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:

Famous Anthony’s “About Us” Page in its website tells the story of a family run, Roanoke institution that has been taken to its knees in bankruptcy because one employee was not vaccinated against hepatitis A. Sadder still are the 50 customers sickened, some so severely that they required liver transplants, and in four instances they died, including two members of the same family.

As its About Page says:

We are often asked what makes us famous.  We’ve always been known for our food and service, but to us, it’s our customer (you!) that makes us famous.  Since 1986 we’ve been an integral part of the community and our story has been woven by our customers, spanning many generations of families.  It’s their stories that makes ours.   

We are still family owned and operated and you can often find Mr. Anthony out and about in the restaurants.  So come by and give us a visit.  As our customers say, visit once and you’re family.

My guess is that Mr. Anthony wishes that he had taken the About Page to heart and protected his family by offering vaccinations to all employees or seeking free vaccines from the local health department.  But, he did not and now it is too late for many customers and for his 40 year old business.

An outbreak of hepatitis A occurred in the early fall of 2021 in Roanoke City, Virginia. The health department was notified about the outbreak on September 21, 2021, after the first case was reported by a local hospital. The Roanoke City Health Department, along with the Virginia Department of Health, investigated this outbreak. Three different Famous Anthony’s locations were ultimately found associated with this outbreak: 6499 Williamson Road, Roanoke; 4913 Grandin Road, Roanoke; and 2221 Crystal Springs Avenue, Roanoke. A public posting was made by the Virginia Department of Health on September 24, 2021, about this outbreak and the potential exposure risk. 

As of November 2021, a total of 52 primary cases (41 confirmed and 11 probable) were identified in this outbreak. Two secondary cases were also identified. Cases ranged from 30 to 82 years of age (median 63). In all, 57 percent of cases were male. Thirty-three cases included hospitalizations, and at least 4 cases involved deaths. Exposures to the Famous Anthony’s food establishments occurred between August 10 and 27, 2021. Illness onsets occurred between August 25 and October 15, 2021.

A cook, who also had risk factors associated with hepatitis A, was found to be infected with hepatitis A while working at multiple Famous Anthony’s restaurant locations. This index case’s mother and adult son also tested positive for hepatitis A. Following an inspection, the inspector noted, “due to the etiology of Hepatitis A transmission, it is assumed the infectious food handler did not perform proper hand washing or follow glove use policy.” It was determined that person-to-person spread was the most likely mode of transmission in this outbreak. Environmental contamination was also considered a possible mode of transmission. 

Exposure to hepatitis A virus (“HAV”) can cause an acute infection of the liver that is typically mild and resolves on its own.[1] The symptoms and duration of illness vary a great deal, with many persons showing no symptoms at all.[2] Fever and jaundice are two of the symptoms most associated with HAV infection.[3]

Hepatitis A is the only common vaccine-preventable foodborne disease in the United States.[4] This virus is one of five human hepatitis viruses that primarily infect the human liver and cause human illness.[5] Unlike hepatitis B and C, hepatitis A does not develop into chronic hepatitis or cirrhosis, which are both potentially fatal conditions.[6]Nonetheless, infection with the hepatitis A virus (HAV) can lead to acute liver failure and death.[7]

Hepatitis A is a communicable (or contagious) disease that often spreads from person to person.[8] Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water.[9] Food-related outbreaks are usually associated with contamination of food during preparation by a HAV-infected food handler.[10] The food handler is generally not ill because the peak time of infectivity—that is, when the most virus is present in the stool of an infected individual—occurs two weeks before illness begins.[11]

According to Lin & Fang[12], the recent upsurgence of hepatitis A transmitted from person-to-person has raised alarm among public health officials. Although hepatitis A is primarily foodborne, hepatitis A virus (HAV) can also be transmitted through close contact. The authors point to increasing rates of person-to-person transmission of hepatitis A across the world since 2015, which international health organizations now recognize as a reemerging health threat. 

In the United States, the increase in hepatitis A outbreaks from 2016 to the present are thought to be at least partially related to people using drugs and being homeless; however, both medical and nonmedical factors account for the observed increase of hospitalization and deaths. Of particular concern is the rising risk of morbidity during this wave of outbreaks. Recent studies cited by Lin & Fang show that more than half (52%) of patients were hospitalized, of whom 10% required intensive care, 4% developed fulminant hepatitis, and 1% died. This is in sharp contrast to past studies, where serious hepatic complications associated with acute hepatitis A were rarely reported. Nonetheless, these findings highlight the importance of HAV vaccinations for at-risk populations. 

As recommended in the United States by the Advisory Committee on Immunization Practices (ACIP), from a public health perspective, HAV vaccination is the most effective prevention strategy to control a person-to-person transmitted hepatitis A outbreak. HAV vaccines are highly immunogenic, and >95% of immunocompetent individuals achieve seroconversion within 4 weeks after the first dose. Despite the benefits of vaccination, several barriers and missed opportunities to vaccination were identified from the experiences during the hepatitis A outbreaks. Hofmeister et. al[13]cite recent research describing that information on HAV vaccination status was missing in nearly two-thirds of study participants, and nearly 90% of those with available information had not previously received HAV vaccines. Citing another study reporting a hepatitis A outbreak in San Diego County, no hepatitis A case patients had ever received a full series of HAV vaccinations.

HAV is relatively stable and can survive for several hours on fingertips and hands, and up to two months on dry surfaces.[14] The virus can be inactivated by heating to 185°F (85°C) or higher for one minute or disinfecting surfaces with a 1:100 dilution  of household bleach in tap water.[15] HAV can still be spread from cooked food if it is contaminated after cooking.[16]

Hepatitis A may cause no symptoms at all when it is contracted, especially in children.[17] Asymptomatic individuals will only know they were infected (and have become immune, given that you can only get hepatitis A once) by getting a blood test later in life.[18] Approximately 10 to 12 days after exposure, HAV is present in blood and is excreted via the biliary system into the feces.[19] Although the virus is present in the blood, its concentration is much higher in feces.[20] HAV excretion begins to decline at the onset of clinical illness, and decreases significantly by 7 to 10 days after onset of symptoms.[21] Most infected persons no longer excrete virus in the feces by the third week of illness. Children may excrete HAV longer than adults.[22]

Seventy percent of HAV infections in children younger than six years of age are asymptomatic; in older children and adults, infection tends to be symptomatic with more than 70% of those infected developing jaundice.[23] Symptoms typically begin about 28 days after contracting HAV but can begin as early as 15 days or as late as 50 days after exposure.[24] The symptoms include muscle aches, headache, anorexia (loss of appetite), abdominal discomfort, fever, and malaise.[25]

After a few days of typical symptoms, jaundice (also termed “icterus”) sets in.[26] Jaundice is a yellowing of the skin, eyes, and mucous membranes that occurs because bile flows poorly through the liver and backs up into the blood.[27] The urine will also turn dark with bile and the stool light or clay-colored from lack of bile.[28] When jaundice sets in, initial symptoms such as fever and headache begin to subside.[29]

In general, symptoms usually last less than two months, although 10% to 15% of symptomatic persons have prolonged or relapsing disease for up to 6 months.[30] It is not unusual, however, for blood tests to remain abnormal for six months or more.[31] The jaundice so commonly associated with HAV can also linger for a prolonged period in some infected persons, sometimes as long as eight months or more.[32] Additionally, pruritus, or severe “itchiness” of the skin, can persist for several months after the onset of symptoms. These conditions are frequently accompanied by diarrhea, anorexia, and fatigue.[33]

Relapse is possible with hepatitis A, typically within three months of the initial onset of symptoms.[34] Although relapse is more common in children, it does occur with some regularity in adults.[35] The vast majority of persons who are infected with hepatitis A fully recover, and do not develop chronic hepatitis.[36] Persons do not carry HAV long-term as with hepatitis B and C.[37]

Fulminant hepatitis A, or acute liver failure, is a rare but devastating complication of HAV infection.[38] As many as 50% of individuals with acute liver failure may die or require emergency liver transplantation.[39] Elderly patients and patients with chronic liver disease are at higher risk for fulminant hepatitis A.[40] In parallel with a declining incidence of acute HAV infection in the general population, however, the incidence of fulminant HAV appears to be decreasing.[41]

HAV infects the liver’s parenchymal cells (internal liver cells).[42] Once a cell has been penetrated by the viral particles, the hepatitis A releases its own toxins that cause, in essence, a hostile takeover of the host’s cellular system.[43] The cell then produces new viral components that are released into the bile capillaries or tubes that run between the liver’s parenchymal cells.[44] This process results in the death of liver cells, called hepatic necrosis.[45]

The fulminant form of hepatitis occurs when this necrotic process kills so many liver cells—upwards of three-quarters of the liver’s total cell count—that the liver can no longer perform its job.[46] Aside from the loss of liver function, fulminant hepatic failure can lead to encephalopathy and cerebral edema.[47] Encephalopathy is a brain disorder that causes central nervous system depression and abnormal neuromuscular function.[48] Cerebral edema is a swelling of the brain that can result in dangerous intracranial pressure.[49] Intracranial hypertensions leading to a brain stem death and sepsis with multiple organ failure are the leading causes of death in individuals with fulminant hepatic failure.[50]

[1]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” in Mandell, Douglas, & Bennett’s PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASES, Fifth Edition, Chap. 161, pp. 1920-40 (2000); Mayo Clinic Staff, “Hepatitis A,” (last updated Sept 1, 2011). Articles available online at http://www.mayoclinic.com/health/hepatitis-a/DS00397.

[2]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[3]           Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[4]           Id.; See also Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” Clinical Infectious Diseases, Vol. 38, 705-715 (March 1, 2004). Full text online at http://www.cdc.gov/hepatitis/PDFs/fiore_ha_transmitted_by_food.pdf.

[5]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[6]           Id.

[7]           Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7; Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

[8]           Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[9]           Id.; See also Jaykus Lee Ann, “Epidemiology and Detection as Options for Control of Viral and Parasitic Foodborne Disease,” Emerging Infectious Diseases, Vol. 3, No. 4, pp. 529-39 (October-December 1997). Full text of the article is available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640072/pdf/9366607.pdf

[10]         Fiore, Anthony, supra note 7; CDC, “Hepatitis A,” supra note 5; See also CDC, “Surveillance for Acute Viral Hepatitis – United States, 2007, Morbidity and Mortality Weekly Report, Surveillance Summaries, Vol. 58, No. SS03 (May 22, 2009) at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5803a1.htm.

[11]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7. 

[12]         Lin, K. Y., & Fang, C. T. (2021). Public health responses to person-to-person hepatitis A outbreaks. The Journal of Infectious Diseases, 223(3), 359-361.

[13]          Hofmeister, M. G., Xing, J., Foster, M. A., Augustine, R. J., Burkholder, C., Collins, J., … & Spradling, P. R. (2021). Hepatitis A person-to-person outbreaks: Epidemiology, morbidity burden, and factors associated with hospitalization—Multiple States, 2016–2019. The Journal of Infectious Diseases, 223(3), 426-434.

[14]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[15]         CDC, “Updated recommendations from Advisory Committee on Immunization Practices (ACIP) for use of hepatitis A vaccine in close contacts of newly arriving international adoptees,” Morbidity and Mortality Weekly Report, Vol. 58, No. 36,  (Sept. 18, 2006), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a4.htm; Fiore, Anthony, et al., Advisory Committee on Immunization Practices (ACIP), Prevention of Hepatitis-A Through Active or Passive Immunization: Recommendations, Morbidity & Mortality Weekly Review, Vol. 55, Report 407, (May 29, 2006) at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm; Todd, Ewan C.D., et al., “Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation-environment,” Journal of Food Protection, Vol. 72, 202-19 (2009). Full text of the article is available online at http://courses.washington.edu/eh451/articles/Todd_2009_food%20processing.pdf.

[16]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7.

[17]         Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7

[18]         Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

[19]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1

[20]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1

[21]         Id.

[22]         Id.; See also Sagliocca, Luciano, et al., “Efficacy of Hepatitis A Vaccine in Prevention of Secondary Hepatitis A Infection: A Randomized Trial,” Lancet, Vol. 353, 1136-39 (1999). Abstract at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(98)08139-2/abstract.

[23]         CDC, “Hepatitis A,” supra note 5.

[24]         Id.: See also Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Fiore, Anthony, Division of Viral Hepatitis, CDC, “Hepatitis A Transmitted by Food,” supra note 7.

[25]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[26]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[27]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[28]         CDC, “Hepatitis A,” supra note 5; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1. 

[29]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[30]         Fiore, Anthony, et al., Advisory Committee on Immunization Practices (ACIP), Prevention of Hepatitis-A Through Active or Passive Immunization: Recommendations,” supra note 20; Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” Medicine, Vol. 71, No. 1, 14-23 (Jan. 1992). Abstract of article online at http://www.ncbi.nlm.nih.gov/pubmed/1312659.

[31]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[32]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[33]         CDC, “Hepatitis A,” supra note 5; Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[34]         Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” supra note 37.

[35]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Gilkson Miryam, et al., “Relapsing Hepatitis A. Review of 14 cases and literature survey,” supra note 37.

[36]         Mayo Clinic Staff, “Hepatitis A,” supra note 1.

[37]         CDC Summary, “Disease Burden from Viral Hepatitis A, B and C in the United States, 2004-2009, at http://www.cdc.gov/hepatitis/pdfs/disease_burden.pdf; CDC, “Hepatitis A,” supra note 5.

[38]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” World Journal of Gastroenterology, Vol. 12, No. 46 pp. 7405-7412 (Dec. 14, 2006). Full article is available online at http://www.wjgnet.com/1007-9327/12/7405.pdf.

[39]         Taylor, Ryan, et al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” Hepatology, Vol. 44, 1589-1597. Full text http://deepblue.lib.umich.edu/bitstream/2027.42/55879/1/21349_ftp.pdf.

[40]         Id.: See also Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[41]         Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46. 

[42]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[43]         Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1; Schiff, E.R., “Atypical Manifestations of hepatitis-A,” supra note 23. 

[44]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

[45]         Id.; See also Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46. 

[46]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46.

[47]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

[48]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supranote 45; Feinstone, Stephen and Gust, Ian, “Hepatitis A Virus,” supra note 1.

[49]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45.

[50]         Detry, Oliver, et al., “Brain Edema and Intracranial Hypertension in Fulminant Hepatic Failure: Pathophysiology and Management,” supra note 45; Taylor, Ryan, et. al., “Fulminant Hepatitis A Virus Infection in the United States: Incidence, Prognosis, and Outcomes,” supra note 46.

ophs-esteban2-profile

Dr. Jose Emilio Esteban as been appointed and confirmed as the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) Under Secretary for Food Safety.Hanukkah

Dr. Esteban was appointed as Chief Scientist of the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) in August 2018. In this capacity, Dr. Esteban serves as the primary scientific advisor on matters of public health and food safety that affect the mission of the Agency, with primary responsibility for scientific initiatives within the Office of Public Health Science (OPHS). Dr. Esteban’s efforts directly support FSIS’ Strategic Goals 1: Prevent Foodborne Illness and Protect Public Health, and 2: Modernize Inspection Systems, Policies, and the Use of Scientific Approaches.

In 2002, Dr. Esteban joined OPHS as the Director of the Western Laboratory. In this role, he directed the implementation of the sampling program and was responsible for the physical plant, equipment and personnel infrastructure. In 2008, he was appointed as the FSIS Science Advisor for Laboratory Services, where he harmonized the operation of all three FSIS laboratories, maintained operations to meet with the ISO17025 standard and coordinated emergency response.

Prior to joining FSIS, Dr. Esteban worked in several positions at the Centers for Disease Control and Prevention (CDC). From 1994 to 2002, he was as an Epidemic Intelligence Service Officer; a Staff Epidemiologist in the National Center for Environmental Health; and an Assistant Director for the CDC Food Safety Office.

He received his Doctorate in Veterinary Medicine from Mexico’s National University, a Master of Business Administration Degree from the Panamerican Institute, and a Master of Preventive Veterinary Medicine Degree, as well as a Doctorate in Epidemiology from the University of California at Davis.

Dr. Esteban, here is some Christmas reading:

Remember this as you prepare Christmas dinner for your family and as you read this post – it is Food Safety and Inspection Service (FSIS) Mission Statement:

Protecting the public’s health by ensuring the safety of meat, poultry, and processed egg products.

USDA/FSIS has the authority to deem Salmonella and other pathogens adulterants – they just need to use it.

In a few days millions of Americans will bring a food product (a turkey) into their homes that is likely teeming with Salmonella that the manufacturer – by law and with the USDA stamp of approval – knowingly can sell knowing that it may well be tainted with a pathogen that sickens over 1,000,000 yearly.  This is because USDA/FSIS does not consider Salmonella an adulterant.

Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense.

Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed’, ” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable.

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different? According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration?

Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been 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; …

Here is the law specifically related to poultry:

Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION

(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been 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;

Hmmm. It is hard to read the above and not think that the words equate to all E. coli as well as Salmonella — frankly, all pathogens in food.

I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.

FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been 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 …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef, poultry, fish and produce industry representatives, and consumers discussing this.

I would pay to watch it.

And so now onto some history to ruin your appetite.

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

Perhaps it is just time for the FSIS to take the the position that all pathogens that can kill you in meat are adulterants.  You have the authority – you just need to use it.

Let the meat industry sue you.  I know a good lawyer to defend you.

Dr. Esteban – I will see you in the New Year.