Dr.  Califf, I have deep admiration for your past and ongoing public service.  The hard work of trying to protect the food and drug supply in the United States is a difficult and at times thankless task.  The fact that you have taken this responsibility on more than once speaks volumes to your character.

Your decision post the infant formula scare and shortage in asking the Regan-Udall Foundation to take a critical look at the culture and structure of the FDA took a bit of confidence and a lot of courage.  I had the honor to testify before your chosen panel and stayed to listen to the full two days of testimony from thought leaders – consumer, industry, academia and government – on how the “F” in FDA could best accomplish its mission.

Pulling from the panel’s recommendations, the FDA’s path to a safer food supply seems clear albeit a lot to “chew on”:

Most FDA employees understand the immense responsibility of the Agency’s Human Foods Program, appreciate the importance of their work, and share a common value of striving to protect public health. However, the current culture, structure, and governance model detract from the Program’s effectiveness. 

There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration. 

The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil…. As senior leaders are considered for the Human Foods Program, an ideal leadership skill set should include: 

  • Expertise and knowledge in food safety and/or nutrition 
  • Ability to make decisions in a complex regulatory environment 
  • Ability to lead in a complex work environment 
  • Strong demonstrated management capability 
  • Superb communication skills 
  • Ability to identify and nurture talent 
  • Commitment to collaboration, not isolation 
  • Capable of breaking down silos 
  • Proven abilities to lead, support, and incent teamwork 
  • Ability to support initiatives that increase staff professionalism and performance 
  • Commitment to joint staff development and other activities by the collective parts of the Human Foods Program 

To move the Human Foods Program toward a more enabling and effective culture, the Panel recommends FDA leadership consider the following:

  • Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.
  • Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.
  • Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework. 
  • Commit to transparency, timeliness, and predictability in decision-making, with a preference towards action. 
  • Commit to an on-going process of culture change from the highest levels of FDA leadership. 
  • Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change. 
  • Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork. 
  • Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.
  • Nurture current staff and recruit, hire, and promote top quality staff, including strong managers. 

FDA should increase the visibility and prominence of the Human Foods Program. 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

  • The Human Foods Program should have clear lines of authority. 
  • Within the Human Foods Program, the importance of nutrition should be elevated. 
  • The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.
  • The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program. 
  • A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

My vision of a more empowered food-side of the FDA would have created two Senate appointed commissioners – one with a portfolio of all aspects of food as mentioned above and one with a portfolio of drugs and medical devices.  However, I learned long ago to listen to those who swim in the deeper end of the intelligence pool.  I think you agree with that.  As you were recently quoted in an interview with the Washington Post:

In 2016, there was a deputy commissioner who was empowered. First, I was very comfortable with it. Secondly, it didn’t fix all the problems. There are still issues within that that need to be dealt with. We are coalescing on a plan. I had a deputy commissioner [when I was FDA Commissioner in 2016]. Scott Gottlieb [the next FDA Commissioner] changed that. If a commissioner comes in with grandiose ideas and gets halfway through a change, that’s not good for people. I think we are going to put in structures that are going to survive.

It seems that you, the Regan-Udall Foundation and the recently departed Frank Yiannas agree on the need for a revised structure within the FDA and the need for a person empowered to deliver and be accountable for creating “the safest food supply in the world”. As Mr. Yiannas recently said:

One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more easily make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.

Dr. Califf, thank you for your leadership.  The 48,000,000 who are sickened yearly by food they consume, the 125,000 hospitalized and the 3,000 that die are counting on you.

Dr. Califf, one final thought; lock the door and do not let Frank Yiannas leave the building.  

Although I do not always agree with Mr. Yiannas on policy, the Regan-Udall Foundation’s definition of “ideal leadership” reads like a Frank Yiannas resume.  The FDA needs someone with broad private sector experience who understands that the power of the FDA to effectuate positive food safety changes – including human nutrition – will come from both consumer and industry stakeholders – not exclusively within the present FDA structure.

When you make the FDA structural change, you need to have someone (Frank Yiannas) at your side.  Do not let this moment pass.  We all depend on you.

This just hit my inbox. I’ll have more to say.

January 25, 2023

Dr. Califf:

This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for FoodPolicy and Response effective February 24.

In December of 2018, I joined the FDA with the goal of helping to modernize the food safety oversight system in the United States and protecting the American people from contaminated food.I wanted to build on my work of protecting consumers by elevating food safety standards and building more effective, modern, and innovative food safety approaches, something I did in the private sector for more than 30 years.

Despite the unprecedented challenges we’ve faced in the past four years (such as a globalpandemic, unparalleled food supply chain disruptions, and six different acting or permanentcommissioners), thanks to the dedicated staff working on food safety throughout the FDA, I believewe made real improvements towards this goal.

Advancing FSMA

First, almost a decade since its passage and after the agency experienced three separate lawsuits(before my arrival) for failing to achieve several Food Safety Modernization Act (FSMA) mandates,we made needed and strategic progress by tackling two of the most critical, complicated, andoutstanding FSMA rulemakings by issuing a Final Food Traceability Rule and a new, proposedAgricultural Water Standard. While the FSMA-projected reductions in foodborne illnesses have yetto be realized a decade later, these two rules, once fully implemented, will be gamechangers inallowing those reductions to become a reality.

A New Era of Smarter Food Safety

But we didn’t stop there. Modern times require more modern approaches. Therefore, shortly aftermy arrival, we assembled some of the brightest minds in food safety from within and outside theFDA to help us prepare for the future. Based on their input, in 2020 and under the auspices of a NewEra of Smarter Food Safety, we unveiled a new vision and blueprint for the next decade tomodernize the way FDA does its food safety work and to bend the curve of foodborne illness onceand for all in this country. And in two short years, we achieved an amazing amount of work. Forexample, we leveraged smarter tools for prevention used for the very first time in FDA’s foodprogram, such as employing Artificial Intelligence to strengthen our ability to detect and preventviolative shipments of imported seafood from reaching the U.S. consumer. We also expedited andfacilitated the use of Tech-enabled Food Traceability to create a more transparent food system.And at a time of heightened food supply chain disruptions, we unleashed the power of data with the development of 21 Forward, a first of its kind food supply chain analytical platform to identify food facilities at greatest risk of food supply chain disruptions. We also launched a pilot to evaluate if select third party food safety standards aligned with FSMA and determine what role they might play in the nation’s food safety oversight system. And we advanced the concept of Food Safety Culture to achieve higher rates of compliance and to mobilize industry to do the same, realizing that advancing food safety requires going beyond traditional approaches, through a betterunderstanding of human behavior and organizational dynamics.

A Record of Prevention

Importantly, while regulatory activities matter, they’re not what matters most. What matters mostis outcomes or proven results that our work is achieving reductions in foodborne illnesses. Andearly indications are that we’ve been successful here too, whether it’s been through our work torally stakeholders to break the cycle of recurring outbreaks around Thanksgiving linked to fresh leafy greens through FDA’s Leafy Green Action Plan or, after 8 years and 8 outbreaks, breaking the cycle of Salmonellosis during the summer linked to imported papayas, through an enhanced Food Safety Partnership between the U.S. and Mexico, as just a couple of examples.

Tackling Foodborne Outbreaks Faster

And while prevention has been and must always be our focus, tackling foodborne outbreaks fasterand revealing their root cause is also essential to preventing future outbreaks, so here too, we made significant progress. For example, we strengthened FDA’s foodborne outbreak investigations and almost doubled the number of outbreak investigation reports the agency now publishes. Also, as a commitment to greater transparency, we began a process of sharing information about theoutbreaks the FDA is investigating through a weekly outbreak update table, even before there is any actionable information. And importantly, we completed an independent review of our outbreak investigation processes that led to the development of a Foodborne Outbreak Response Improvement Plan.

I want to THANK all of those in the FDA who have committed themselves to these efforts and I hopethat they are given the opportunity to continue this important work in the future. I hold the foodsafety staff throughout the agency in the highest regard, for their expertise, their experience, and –most of all – their commitment to the public.

Looking to the Future

In February 2022, as you rejoined the agency, I shared with you that I was considering leaving,expressing my concern that the decentralized structure of the foods program that you and I bothinherited, significantly impaired FDA’s ability to operate as an integrated food team and protect thepublic.

It was also in February of 2022 that I first learned of the infant formula incidents the had beenreported to various parts of the FDA several months before, so I postponed this decision anddedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facilitynow reopened, infant formula availability more prevalent, and – very importantly – the necessarymonitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position.

My fervent hope is that American consumers, especially mothers and fathers of infants, never againhave to face this type of preventable situation. It is incumbent on any public organization that hasundergone a crisis of this magnitude to undergo an independent and thorough review to understand how the crisis happened, what can be done to prevent it from happening again, and that the findings be transparently shared with the public. I am grateful that Congressional leaders have demanded that this happen and that the Office of the Inspector General has initiated its owninvestigation.

Lastly, while I respect that these are decisions only you can make, I do want to leave you with acouple of points for consideration. One, based on my experience these past four years, I (as well asa diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & IndustryStakeholder Groups) firmly believe the agency would operate more effectively and be better able toprotect the American public from foodborne illness, with the creation of a more integratedoperating structure and a fully empowered and experienced Deputy Commissioner for Foods, withdirect oversight of those centers and offices responsible for human and animal foods. In thismanner, she or he can more easily make the necessary changes that are needed to transform FDA’sFood Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of theDeputy Commissioner for Foods.

In closing, I will always remain grateful for the opportunity to have served our one and only trueboss, the approximate 340 million American consumers nationwide. Serving them has been a honor and privilege.

Frank Yiannas

Deputy Commissioner, Food Policy and Response

In the 30 years since the Jack in the Box outbreak, food safety has come a long way. Here are some of the people who have shaped it.

JANUARY FEBRUARY 2023 – https://www.qualityassurancemag.com/article/the-food-safety-set/

Row 1: Caroline Smith DeWaal, James Marsden, Darin Detwiler, Rosa DeLauro. Row 2: Frank Yiannas, Ann Marie McNamara, Dick Durbin, Bill Marler. Row 3: Mike Taylor, Craig Wilson, Sandra Eskin, Bill Keene

Food Safety Over the Last 30 Years

By Steven Mandernach, executive director, Association of Food and Drug Officials

When I talk to food safety leaders across the country and from around the world, we often discuss what has changed, how things are different. Many pathogens are the same: Salmonella, E. coli and Listeria monocytogenes continue to be persistent foodborne illness pathogens of concern, though significant progress has been made with all. Many, such as Cyclospora, norovirus and Hepatitis A, were largely unknown as potential foodborne illnesses. Produce and eggs were not known vehicles for illness, yet they have dominated much of the last 30 years of illnesses. In 1992, we hadn’t really thought that what happens at the farm level can affect food safety throughout the supply chain. 

Thirty years ago, a food safety professional’s work often focused on cleanliness and hygiene, but today, it’s more focused on process and prevention. Our facilities and establishments now often have and are required to have HACCP or food safety plans along with well-developed standard operating procedures. Further, we recognize that much of food safety isn’t necessarily based in microbiology, but rather soft “power” skills such as human behavior. 

Technologically speaking, cell phones were a thing of Hollywood 30 years ago, computers were somewhat rare, and handheld devices were on Star Trek, not found in the real world. Today, we are in an age of instant communication, and information expectations are immediate for everyone in the food chain, including the farmer, consumer and regulator. Further, laboratory testing that may have taken weeks or longer now often takes hours or only minutes. Also, we are regularly using DNA fingerprinting, which has advanced greatly since 1992, to identify smaller and smaller clusters for outbreaks. Many outbreaks now can be solved in days rather than weeks or months. 

Today, like then, we have many curious food safety professionals asking questions and advancing the body of knowledge. We have many areas that require yet more research, for example, on the transmission of pathogens through produce. Knowledge of Cyclospora remains tiny, and we have yet to find the silver bullet for human behavior, which is likely the most challenging component of food safety. 

One common factor across the past 30 years is people. We have had talented people and policy makers in industry, academia, regulatory, public health and consumer groups who have been unwilling to accept the status quo. These passionate food safety leaders insisted on and expected food safety to improve with knowledge, and they pushed to develop the knowledge where none existed. Work by these leaders has nearly eliminated some pathogens such as botulism, made significant reductions in others and kept the spotlight and focus in the public and C-suite on food safety. 

As we reflect on the 30th anniversary of the Jack in the Box E. coli outbreak, which in so many ways provided increased awareness of foodborne illness, we need to celebrate the people who have helped improve the safety of our national and global food supplies. These people have persevered where their message was often unpopular and expensive, and they managed to truly impact our world. 

These leaders would likely tell the emerging food safety leaders a few important things. 

  • You will always want more information than is available — but react with prevention and mitigation in mind, rather than complete certainty.
  • Not everything works. Periodic failures and persistence lead to successes.
  • Think, hypothesize, experiment and try: These actions result in improvements in food safety and the reduction of illness.
  • Build a community: Nothing can be accomplished alone. Everything requires friends, colleagues, critics and others.
  • Mentor and collaborate with others to build the next community of leaders.

Most importantly, though, do what’s right to prevent human illness. These leaders featured in the following pages can each be credited with work that improved food safety and further limited or reduced human illness. Food consumers — all of us — thank them for their courage, leadership and persistence in making food safer and reducing foodborne illness.

In the 30 years since the 1992-93 Jack in the Box E. coli outbreak, food safety policies, advocacy and research have come a long way. While there’s still more to be done, here are some of the people who have helped shape the last 30 years of food safety. 

Rosa DeLauro, The Representative

Rosa DeLauro, U.S. representative for Connecticut’s third congressional district since 1991, has long been vocal about food safety. She was a key leader in writing the Food Safety Modernization Act (FSMA), signed into law in 2011. She championed regular inspections of high-risk industrial food facilities, food companies taking preventive measures, a better system for tracing food and imported food meeting U.S. safety standards. In July 2022, she and Sen. Dick Durbin (also a member of The Food Safety Set) introduced the Food Safety Administration Act, legislation that would establish the Food Safety Administration, a single food safety agency responsible for keeping the food Americans consume safe for market. She and Durbin have advocated for streamlining the country’s food safety system since 2015. 

Darin Detwiler, The Professor 

Darin Detwiler didn’t have to take up the foodborne illness cause after his son, Riley, died in 1993 due to E. coli as part of the Jack in the Box outbreak. But the former U.S. Navy submariner turned tragedy into an opportunity to advocate and educate, working with groups such as IAFP and STOP Foodborne Illness and advising government agencies such as FDA and USDA. With more than 20 years’ teaching experience, he’s currently an associate teaching professor of regulatory affairs of food and food industry at Northeastern University. He’s received many awards, including IAFP’s Ewen C.D. Todd Control of Foodborne Illness Award in 2022. It’s all been part of an effort to help prevent more deaths such as Riley’s. “If 3,000 families are dealing with [foodborne illness] every year, that’s 90,000 families since my son died,” he told us in 2021. 

Nancy Donley, The Advocate 

After the death of her son, Alex, in 1993 due to E. coli, Donley dedicated herself to extensive advocacy with STOP Foodborne Illness, including serving as the organization’s president. She worked collaboratively with federal food safety agencies, industry, academia and other consumer groups in advancing stronger food safety practices and policies. Donley participated in numerous media interviews in efforts to build awareness of foodborne risk and educate the public on how best to protect themselves. Among other awards, Donley received NSF International’s 2011 International Lifetime Achievement Award for her “extraordinary efforts, outstanding dedication, and endless passion for food safety.” 

Dick Durbin, The Reformer 

Now in his fifth term, Sen. Dick Durbin of Illinois co-authored the FDA Food Safety Modernization Act — signed into law in 2011 and described by FDA as the most comprehensive food safety reform in 70 years — after receiving a letter from the mother of a child who died in 1993 after eating a hamburger contaminated with E. coli. Most recently, in July 2022, he and former Chair of the House Appropriations Committee Rosa DeLauro (also a member of The Food Safety Set) introduced the Food Safety Administration Act, legislation that would establish the Food Safety Administration, a single food safety agency responsible for keeping the food Americans consume safe for market. Durbin and DeLauro have argued in favor of consolidating the country’s food safety functions into one independent agency since 2015.

Sandra Eskin, The Consultant 

Sandra Eskin, deputy under secretary for food safety at the United States Department of Agriculture (USDA), spent nearly 20 years as a public-policy consultant to numerous consumer advocacy and public-interest organizations, providing strategic and policy advice on consumer protection issues such as food safety, dietary supplement safety and food and drug labeling and advertising. Prior to joining USDA, she was project director for food safety at The Pew Charitable Trusts. She currently oversees the Food Safety and Inspection Service (FSIS), which last year proposed regulatory framework for a new strategy to control Salmonella contamination in poultry products. Aside from her food safety work, she is also an award-winning children’s playwright. 

Bill Marler, The Lawyer

Bill Marler is recognized as one of the most prominent foodborne illness lawyers in America and a major force in food policy in the U.S. and around the world. He began litigating foodborne illness cases in 1993 and has since represented victims of nearly every large foodborne illness outbreak in the U.S. “If you do everything you can to prevent illness, you’re likely to prevent illness,” he told QA magazine in 2020. “And if that’s not something you think is doable, then maybe you’re not in the right business.” Marler’s advocacy for a safer food supply includes petitioning the USDA to better regulate pathogenic E. coli, working with nonprofit food safety and foodborne illness victims’ organizations and helping spur the passage of FSMA. 

Bill Keene, The Epidemiologist 

Bill Keene was a senior epidemiologist who, prior to his death in 2013, dedicated 23 years to the Oregon Health Authority’s Acute and Communicable Disease Prevention section. He and his team were able to trace the origins of numerous foodborne illnesses across the nation, including a 2008 Salmonella outbreak involving jalapeño peppers that sickened more than 1,200 and killed two people. Keene had a remarkable impact on the field of food safety and was known around the world for his persistence, curiosity and enthusiasm for fieldwork. Considered by many, including USA Today, as one of the nation’s foremost food safety sleuths, his work likely saved countless lives. Keene created the International Outbreak Museum in Portland, Ore. 

James Marsden, The Problem Solver

James Marsden was enlisted to turn the food safety program around at Chipotle Mexican Grill in 2016 following a series of norovirus, E. coli and Salmonella outbreaks at various Chipotle locations. No stranger to crisis, Marsden, who has over 40 years of experience in the industry, previously served as vice president of scientific and technical affairs at the American Meat Institute, working to improve the meat inspection process following the 1993 Jack in the Box E. coli outbreak. A retired Kansas State University professor of meat science for 21 years, Marsden’s research focused on the safety of meat products and food safety training for the meat industry. Fun fact: he is father to actor James Marsden of “Enchanted” and “X-Men” fame. 

Ann Marie McNamara, The Industry Stalwart 

Currently the vice president of food safety and quality for supply chain at US Foods, Ann Marie McNamara’s other notable leadership roles include vice president of food safety and regulatory compliance at Jack in the Box, director of the microbiology division at USDA’s FSIS and more. She co-authored USDA’s Pathogen Reduction/HACCP rule that, for the first time, required microbiological testing and a risk-based approach to controlling hazards in foods. In 2022, IAFP presented her with their Food Safety Award in recognition of her long history of outstanding contributions to food safety research and education. McNamara delivered IAFP’s 2018 John H. Silliker Lecture, speaking on the topic of “Heroes Past and Future.” 

Caroline Smith DeWaal, The International Activist

Caroline Smith DeWaal founded Safe Food International in 2004, where she helped develop guidelines for consumer organizations to promote national food safety systems, as well as an information resource to track food outbreaks in multiple world regions to identify emerging trends and public health priorities. For 21 years, she was the director of food safety at the Center for Science in the Public Interest, where she directed policy formulation and execution on food safety issues and made numerous appearances before congressional committees to deliver testimony on food safety issues. She then spent five years as FDA’s International Food Safety Policy Manager, coordinating international projects and leading negotiations with foreign governments. She is now deputy director of EatSafe, working to improve food safety in countries with high rates of foodborne illness. 

Trevor Suslow, The Produce Safety Specialist 

As one QA advisory board member put it, Trevor Suslow “has been at the forefront of the research on food safety for leafy greens and is a driving force behind the food safety standards for produce. He’s smart, innovative and someone who is respected by industry, academia and regulators.” Suslow helped found DNA Plant Technology Corp. before joining the faculty at University of California-Davis, teaching and leading research around the safety and quality of whole and fresh-cut produce. Suslow also served as vice president of food safety at the Produce Marketing Association for two years. He’s been recognized for his impact, receiving IAFP’s 2018 Elmer Marth Educator Award and the 2019 IAFP President’s Recognition Award. 

Dr. Robert Tauxe, The CDC Constant 

Dr. Robert Tauxe first joined the CDC in 1985, where he played a role in foodborne illness outbreaks such as the 2008 jalapeno Salmonella outbreak. He also helped develop PulseNet, a network of state public health departments across the U.S. to keep track of E. coli O157 and other foodborne illness pathogens. “Because of PulseNet, we’re able to identify outbreaks sooner than we used to,” he told PBS back in 2002. “And we’re able to identify a new category of outbreaks that we never would have identified before.” Tauxe holds faculty appointments at the Emory University School of Public Health in the Department of International Health as well as the Emory University Department of Biology. He has authored or co-authored more than 250 scientific journal articles, letters and book chapters. After retiring from the agency in 2008, he stayed on as a civilian employee. 

Mike Taylor, The Consumer Advocate 

As administrator of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), Mike Taylor was the government official who, after the deadly Jack in the Box outbreak, ruled that the pathogen E. coli is an adulterant in meat. He helped establish a new food safety regulatory program to prevent foodborne illness from meat and poultry in response to the outbreak. He was Deputy Commissioner for Foods and Veterinary Medicine at FDA for six years, where he oversaw implementation of the Food Safety Modernization Act (FSMA). He currently co-chairs the board of STOP Foodborne Illness, a nonprofit consumer advocacy group that supports victims of foodborne illness and their families in efforts to strengthen food safety culture and practices in government and industry. 

Dave Theno, The Crusader 

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 E. coli outbreak and is credited by many with having saved the company. Theno’s prior positions include food safety and quality programs at Armour Food, Kellogg’s, Foster Farms and his own consulting company. Food safety industry veteran Bruce Ferree once wrote that Theno often said, “Food safety is not a competitive advantage. We need to share and work together to achieve this level of success.” His leadership in industry-wide improvement in food safety is recognized by many, including posthumously through the Dave Theno Food Safety Fellowship at STOP Foodborne Illness. 

Craig Wilson, The Retailer 

Craig Wilson’s title is probably longer than yours. He’s vice president, general merchandising manager of quality assurance/food safety, non-foods product safety and quality assurance, environmental services/HAZMAT and merchandise services for Costco Wholesale Corp. So, imagine having to say or write that out every time he gives a keynote address or joins an industry board, both of which happen a lot. Aside from numerous appearances at events such as the Food Safety Summit, Wilson has served on the steering committee for the National Food Safety Consortium and the technical committee at the Global Food Safety Initiative. And he’s not just a good talker. Wilson holds patents, such as one for steam pasteurization of food, and published a number of research papers covering food processing and safety. 

Frank Yiannas, The Forward Thinker 

Innovation is one of Frank Yiannas’ favorite words. He told us so himself in a 2019 QA cover story. “It’s important to advance food safety with change and innovation,” he said at the time. At each career stop he’s made, first at Walt Disney Co., then at Walmart and now at FDA, he’s helped usher in a transformation of some kind. Whether it’s food safety culture, which he’s written two books on, or traceability via blockchain, Yiannas has long advocated for and implemented technological innovations for food safety advancement and supply chain traceability and transparency and helped usher in FDA’s New Era for Smarter Food Safety. A registered microbiologist, he’s also taught as an adjunct professor at Michigan State University and received numerous industry awards, such as the 2015 Industry Professional Food Safety Hero Award from STOP Foodborne Illness.

Here are some cases where prosecutors brought criminal charges:

In 1998 in what the first criminal conviction in a large-scale food-poisoning outbreak was, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other people in several states in 1996. Odwalla, based in Half Moon Bay, California pleaded guilty to 16 counts of unknowingly delivering ”adulterated food products for introduction into interstate commerce” in the October 1996 outbreak, in which a batch of its juice infected with the toxic bacteria E. coli O157:H7 sickened people in Colorado, California, Washington and Canada. Fourteen children developed a life-threatening disease (hemolytic uremic syndrome -HUS) that ravages kidneys. At the time, the $1.5 million penalty was the largest criminal penalty in a food poisoning case.  Odwalla also was on court-supervised probation for five years, meaning that it had to submit a detailed plan to the food and drug agency demonstrating its food safety precautions and that any subsequent violations could have resulted in more serious charges.

 In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth-generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. They eventually pleaded guilty and were sentenced to five years’ probation.

In 2013 Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010 and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail.

 In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. Stewart Parnell, Michael Parnell, and Mary Wilkerson were all found guilty on multiple charges.  Stewart and Michael are spending decades in prison.

In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.

In 2020 Chipotle was ordered to pay $25 million to resolve criminal charges related to the company’s involvement in foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. Chipotle was implicated in at least five foodborne illness outbreaks between 2015 and 2018 connected to restaurants in the Los Angeles area, Boston, Virginia, and Ohio.  These incidents primarily stemmed from store-level employees’ failure to follow company food safety protocols at company-owned restaurants, including a Chipotle policy requiring the exclusion of employees who were sick or recently had been sick. For example, in August 2015, 234 consumers and employees of a Chipotle restaurant in Simi Valley, California reported becoming ill.  Although company policies required the restaurant to report certain employee illnesses to Chipotle safety officials and to implement enhanced food safety procedures, the restaurant did not pass along information regarding an ill employee until multiple consumers already had reported being sick. In December 2015, a norovirus incident at a Chipotle restaurant in Boston sickened 141 people.  According to the DPA, that outbreak likely was the result of an ill apprentice manager who was ordered to continue working in violation of company policy after vomiting in the restaurant.  Two days later, the same employee helped package a catering order for a Boston College basketball team, whose members were among the consumers sickened by the outbreak. In July 2018, approximately 647 people who dined at a Chipotle restaurant in Powell, Ohio reported illness related to Clostridium perfringens, a pathogen that grows rapidly when food is not held at appropriate temperatures.  The local health department found critical violations of local food regulations, including those specific to time and temperature controls for lettuce and beans.

In 2020 Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products.  The sentence, imposed by U.S. District Judge Robert Pitman in Austin, Texas, was consistent with the terms of a plea agreement previously filed in the case.  The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case. In March 2015, tests conducted by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food.  The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015.  Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement on March 23, 2015. According to the plea agreement with the company, FDA inspections in March and April 2015 revealed sanitation issues at the Brenham and Broken Arrow facilities, including problems with the hot water supply needed to properly clean equipment and deteriorating factory conditions that could lead to insanitary water dripping into product mix during the manufacturing process.  Blue Bell temporarily closed all of its plants in late April 2015 to clean and update the facilities. Since re-opening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment. Paul Kruse, President and CEO of Blue Bell Ice Cream, is faced a felony trial in 2022. 

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

Abbott Under Federal Criminal Investigation Over Baby Formula

Michigan plant at center of probe was temporarily closed by the company last year after potentially deadly bacteria was found. https://www.wsj.com/articles/abbott-under-criminal-investigation-over-baby-formula-11674255871?mod=business_lead_pos1

The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and worsened a nationwide formula shortage, people familiar with the matter said.

Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, the people said. 

The branch, which has criminal as well as civil authority, was involved last year in a settlement with Abbott that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there. 

“The DOJ has informed us of its investigation, and we’re cooperating fully,” an Abbott spokesman said.

The investigation signals further scrutiny of Abbott’s operation of the plant, a major source of baby formula in the U.S., and perhaps of the more than $4 billion formula industry.

The Justice Department in the past decade has investigated numerous food companies that have shipped contaminated products that resulted in illnesses or deaths. 

Several have led to criminal prosecutions under the 1938 Federal Food, Drug and Cosmetic Act of companies or executives involved in producing goods from ice cream to peanut butter. The law allows government officials to prosecute entities or individuals who introduce adulterated food into interstate commerce.

In many recent cases, DOJ has been able to successfully prosecute defendantson misdemeanor charges for introducing contaminated food into the market even without proof that officials acted with criminal intent, according to Bill Marler, a Seattle lawyer who represents victims of food-borne illnesses.  

Abbott, based outside Chicago, is one of the biggest manufacturers of baby formula. The company sells Similac, among other brands.

Last January, FDA inspectors found bacteria at the plant after receiving reports of babies who drank the company’s formula and became sick. The inspectors also found standing water, damage to drying equipment and defects in the seams of formula cans, among other problems at the Sturgis plant. 

Federal officials couldn’t conclusively link the bacteria at the plant to the infants’ illnesses, however. Abbott has said genetic sequencing of the bacteria in the sick babies didn’t match the strains found at the plant.

Abbott temporarily halted production at the Sturgis factory in February, and recalled baby formula made at the plant. The moves contributed to an infant formula shortage that sent parents and federal officials scrambling for months.

To bolster supplies, the federal government waived regulatory requirements and tariffs to allow more foreign formula into the country, and the White House organized planes to fly baby formula to the U.S. 

Abbott last May signed a legal agreement, called a consent decree, detailing the steps it would need to take to reopen the plant. 

In the complaint accompanying that civil agreement, the Justice Department said Abbott and several of its employees had caused “adulterated food” to enter interstate commerce.

“Ongoing inadequacies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department said in the complaint.

In May I wrote:

According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula.  Abbott denies the connection.  However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula.  The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.

Screen-Shot-2022-09-06-at-4.50.46-PM

I must admit I was a bit suspect when I flew from Seattle to DC a few months ago to testify for 5 minutes before the Independent Expert Panel. Putting aside if they would pay attention to me, but would the panel take to heart the experience and thoughtfulness of all the panels and the panel members. From a read of the report, I think they did. Now the question is will Congress and the FDA Commissioner take the recommendations to heart?

Here are a few highlights cut from the final report:

Culture

Most FDA employees understand the immense responsibility of the Agency’s Human Foods Program, appreciate the importance of their work, and share a common value of striving to protect public health. However, the current culture, structure, and governance model detract from the Program’s effectiveness. 

There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration. 

The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil…. As senior leaders are considered for the Human Foods Program, an ideal leadership skill set should include: 

·       Expertise and knowledge in food safety and/or nutrition 

·       Ability to make decisions in a complex regulatory environment 

·       Ability to lead in a complex work environment 

·       Strong demonstrated management capability 

·       Superb communication skills 

·       Ability to identify and nurture talent 

·       Commitment to collaboration, not isolation 

·       Capable of breaking down silos 

·       Proven abilities to lead, support, and incent teamwork 

·       Ability to support initiatives that increase staff professionalism and performance 

·       Commitment to joint staff development and other activities by the collective parts of the Human Foods Program 

To move the Human Foods Program toward a more enabling and effective culture, the Panel recommends FDA leadership consider the following:

·       Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.  

·       Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.

·       Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework. 

·       Commit to transparency, timeliness, and predictability in decision-making, with a preference towards action. 

·       Commit to an on-going process of culture change from the highest levels of FDA leadership. 

·       Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change. 

·       Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork. 

·       Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.

·       Nurture current staff and recruit, hire, and promote top quality staff, including strong managers. 

Structure

FDA should increase the visibility and prominence of the Human Foods Program. 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

The Human Foods Program should have clear lines of authority. 

Within the Human Foods Program, the importance of nutrition should be elevated. 

The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.

The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program. 

A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

Structure changes should be implemented with cultural transformation efforts.

Honestly, this is what I focused on. I am convinced if you get the structure right and the right leaders in place, the culture will develop and the resources will be available. The Panel had five structural option. My preference is the first one:

Resources

The expectations of the FDA Human Foods Program and its impact on public health and our nation’s economy are immense. However, relatively modest increases in federal budget authority, flat staffing levels, and lack of sustained and sufficient commitment to upgrading information technology (IT)— contrasting with a rapidly changing food industry– have constricted the ability of the Human Foods Program to carry out its mission efficiently and effectively. In addition to aforementioned cultural and structural changes, the FDA’s Human Foods Program urgently needs additional personnel, financial, and IT resources to perform its Congressional mandate more effectively.

Here is the full report: https://www.marlerblog.com/files/2022/12/Human-Foods-Program-Independent-Expert-Panel-Final-Report-120622.pdf

Criminal sanctions – Please.

Here are the low lights of the FDA Warning Letter to Big Olaf’s on December 9, 2022.

According to the Centers for Disease Control and Prevention (CDC), 28 ill people from 11 states were infected with the outbreak strain of L. monocytogenes. One patient died and there was a miscarriage in a pregnant patient. On July 13, 2022, the firm recalled all ice cream products and lots of Big Olaf brand ice cream through June 30, 2022, because they had the potential of being contaminated with L. monocytogenes.

In a Dec. 9, 2022, warning letter, the FDA described a July 19 through Sept. 1, 2022, inspection of Big Olaf Creamery LLC in Sarasota, FL.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

Multi-state outbreak of Listeriosis linked to Big Olaf ice cream

The CDC, FDA, Florida Department of Health, and Florida Department of Agriculture and Consumer Services (FDACS) investigated this multi-state outbreak of Listeria. monocytogenes infections linked to ice cream produced by Big Olaf Creamery. This investigation determined at least 28 ill people in 11 states were infected with the outbreak strain of Listeria monocytogenes. Whole genome sequencing was performed on Listeria bacteria from the 28 ill people and showed that the Listeria were closely related genetically to one another indicating that ill people became sick from consuming the same food. Fourteen ill people are residents of Florida, and eleven reported traveling to Florida prior to illness onset. Among 28 ill people with available information, 27 were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis have been reported.

In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of 23 people interviewed, all reported eating ice cream and 16 specifically reported eating Big Olaf ice cream or at locations supplied by Big Olaf Creamery in the month before their illnesses started; one additional ill person reported eating ice cream more than one month prior to illness onset. It can take up to 70 days for symptoms of Listeria infection to develop.

The overall epidemiologic data, illness sub-cluster information, and food histories of travelers to Florida strongly indicate that Big Olaf Creamery ice cream is the source of illnesses in this outbreak of Listeria monocytogenes infections, according to the warning letter.

Furthermore, on July 7 and 9, 2022, FDACS collected samples (environmental swabs of Big Olaf’s production environment and finished, packaged ice cream product), in which 10 environmental swab isolates and 20 ice cream product isolates match the clinical outbreak isolates from 2022 and 2021 based on WGS analysis.

After the product recall and in response to FDACS’s positive Listeria monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, the firm contracted with a third-party laboratory to conduct environmental swabbing (redacted). Multiple pieces of equipment used to manufacture ready-to-eat (RTE) ice cream products were reported positive for Listeria monocytogenes by their contract laboratory, including (redacted). Additionally, four swabs of finished product ice cream buckets (redacted) were reported positive for Listeria monocytogenes.

The presence of Listeria monocytogenes in the firm’s facility and their products is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

1. The firm did not prepare, or have prepared, and implement a food safety plan, as required. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required. The firm’s food safety plan must also include the following:

1) Written hazard analysis;

2) Written preventive controls;

3) Written supply-chain program;

4) Written recall plan;

5) Written procedures for monitoring the implementation of the preventive controls;

6) Written corrective action procedures;

7) Written verification procedures.

However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of the (redacted) different RTE ice cream products manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. 

Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the RTE ice cream products manufactured, processed, packed, or held by their facility will not be adulterated or misbranded. 

Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. They must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically, for their RTE ice cream products:

a) The firm did not identify and evaluate contamination with environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Their facility manufactures RTE ice cream products which are exposed to the environment during processing. The ice cream machine is (redacted). Also, (redacted). The packaged RTE ice cream products (redacted) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control.

b) The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures (redacted) different RTE milk-based ice cream products, with a variety of flavors and inclusions. Some inclusions contain allergens (such as tree nuts (e.g., pecans), peanuts, and cookie pieces (wheat)). (redacted). In addition, inclusions are (redacted). These bins and scoops (redacted). Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be declared are included on the label.

c) The firm did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard in certain ingredients to determine whether they require a preventive control. Their process does not apply a (redacted) step to any of their (redacted). A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control in these ingredients, and because these hazards are controlled at their suppliers, the appropriate type of control is a supply-chain control. Further, a facility that identifies raw materials and other ingredients with hazards such as bacterial pathogens that require a supply-chain-applied control must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities.

During the inspection, the firm provided a draft SOP (standard operating procedure) that included various operational procedures intended to address food safety hazards associated with their manufacturing operations. It included a statement that going forward their firm will (redacted). However, this draft procedure did not fully explain how they will ensure control of hazards requiring a preventive control in their ice cream products.

For example:

  • Regarding the hazard of contamination with environmental pathogens, the draft procedure did not describe (redacted). Also, it did not include details of their (redacted).
  • Regarding the hazard of allergens, the draft procedure did not describe (redacted). Also, it did not include a (redacted) to ensure the appropriate allergens are declared on labels for each product.
  • Regarding the hazard of pathogens associated with ingredients such as nuts, the draft procedure did not (redacted). Also, it did not indicate that they (redacted).

The full warning letter can be viewed here.

Here is how and why to prosecute.

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.

This Listeria outbreak is a mess. Illnesses began in January 2021 and are likely to be continuing. Listeria has been found on equipment in the the ice cream processing facility and in 16 of 17 flavors. Big Olaf first refused to recognize that it was the cause of the outbreak and refused to stop production and stop ice cream sales. According to the Florida Department of Agriculture and Consumer Services (FDACS):

“The results from product sampling taken from the Big Olaf production facility last week by FDACS found that 16 of the 17 flavors tested were positive for Listeria monocytogenes (L. mono). This includes Blueberry Cheesecake, Butter Pecan, Cherry Cordial, Chocolate, Chocolate Chip, Coconut, Coconut Almond Joy, Cookie Dough, Cookies & Cream, Kahlua Krunch, Mint Chip, Pistachio, Plantation Praline, Superman, Vanilla, and White Chocolate Raspberry. With these results, FDACS is currently issuing formal stop sales on the 16 products where L. mono was found, which were previously part of a voluntary recall. Our department continues to work closely with our state and federal partners on this investigation and enforcement of the stop sale.”

Please find linked here [dropbox.com] the results for the product samples that represent the 16 positive flavors. The one outstanding environmental sample [dropbox.com] noted previously has also come back positive, bringing the total positive environmental samples to 10, and I’m linking here [dropbox.com] to those results.

According to the CDC, as of December 29, 2022, a total of 15 people infected with the outbreak strain of Salmonella have been reported from three states Nebraska (8), Oklahoma (1) and South Dakota (6). Illnesses started on dates ranging from December 2, 2022, to December 13, 2022 linked to SunSprout alfalfa sprouts. That number is likely and undercount and that number will likely increase.

I have lost track of the numbers of “Sproutbreaks” over the years linked to E. coli, Salmonella or Listeria. My fiends at Barblog have been tracking “Sproutbreaks” for years: “We document at least 55 sprout-associated outbreaks occurring worldwide affecting a total of 15,233 people since 1988. A comprehensive table of sprout-related outbreaks can be found here.“

Is it past time for a warning label for sprouts?

Perhaps the labeling could mirror the requirements now found on unpasteurized juices?

WARNING: This product may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

Or, perhaps a bit further?

As far back as September 1998, FDA issued a warning against sprouts urging:

Children, pregnant women and the elderly should not eat alfalfa sprouts until growers find a way to reduce the risk of a potentially deadly bacteria that infects some sprouts, the Food and Drug Administration said this week. The FDA, which is investigating sprout industry practices, said children, the elderly and people with weakened immune systems should avoid eating sprouts. The agency’s statement, issued Monday, repeated similar but little-noticed advice the U.S. Centers for Disease Control gave to doctors and researchers a year ago.

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present. Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide. Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts. Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

I think it is time for a warning label — past time. Here is my idea: