Former Blue Bell Creameries President Charged In Connection With 2015 Ice Cream Listeria Contamination

A Texas grand jury charged the former president of ice cream manufacturer Blue Bell Creameries L.P. with wire fraud and conspiracy in connection with an alleged scheme to cover up the company’s sales of Listeria-tainted ice cream in 2015, the Justice Department announced today.

In an indictment filed in federal court in Austin, Texas, former Blue Bell president Paul Kruse was charged with seven counts of wire fraud and conspiracy to commit wire fraud related to his alleged efforts to conceal from customers what the company knew about Listeria contamination in certain Blue Bell products. According to the indictment, Texas state officials notified Blue Bell in February 2015 that two ice cream products from the company’s Brenham, Texas, factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems.  Kruse allegedly orchestrated a scheme to deceive certain Blue Bell customers, including by directing employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason for the withdrawal.  The indictment alleges that Kruse directed employees to tell customers who asked about the removal that there was an unspecified issue with a manufacturing machine.  The company did not immediately recall the products or issue any formal communication to inform customers about the potential Listeria contamination.

“American consumers trust that the individuals who lead food manufacturing companies will put the public safety before profits,”  said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “The Department of Justice will take appropriate action against those who ship contaminated products and choose not to tell consumers about known risks.”

“U.S. consumers rely on food producers and suppliers to ensure the safety of the nation’s food supply.  The charges announced today show that if an individual violates food safety rules or conceals relevant information, we will seek to hold them accountable,”  said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration (FDA). “We will continue to investigate and bring to justice those who jeopardize public health.”

“The Defense Criminal Investigative Service’s number one priority is the safety and well-being of America’s warfighters and their families,”  said Michael Mentavlos, Special Agent-in-Charge of the Department of Defense Criminal Investigative Service (DCIS) Southwest Field Office.  “The results of this investigation are an example of DCIS’ determination to enforce food safety standards, as required by Defense Department contracts.  These standards not only protect individuals, but are paramount to military readiness.”

The indictment, returned Tuesday in U.S. District Court for the Western District of Texas, further alleges that March 2015 tests conducted by the FDA and the 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 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 resulted in a second recall announcement on March 23, 2015. Additional positive test results ultimately led Blue Bell to recall all ice cream products in April 2015.

Blue Bell pleaded guilty in a related case in May to two counts of distributing adulterated food products in violation of the Federal Food, Drug, and Cosmetic Act. On Sept. 17, 2020, the court sentenced the company to pay criminal penalties totaling $17.25 million. Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities, including the military.  The total $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food safety matter.

Blue Bell temporarily closed all of its plants in late April 2015 to clean and update its 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.

Kruse was previously charged by criminal information on May 1, 2020, during the temporary closure of grand juries in the Western District of Texas due to the COVID-19 pandemic.  That criminal information later was dismissed without opposition from the government, and the new indictment returned by the grand jury, which has resumed operations, now sets out the charges against Kruse.

The indictment filed against Kruse merely alleges that crimes have been committed.  All defendants are presumed innocent until proven guilty beyond a reasonable doubt.

Patrick Hearn and Matt Lash of the Civil Division’s Consumer Protection Branch are prosecuting the case with assistance from Shannon Singleton of the FDA’s Office of Chief Counsel.  The criminal investigation was conducted by the FDA’s Office of Criminal Investigations and the DCIS.

Registration is now open for the Virtual Food Safety Summit 2020 South Africa, scheduled for 3rd November 2020. This event is a joint venture hosted by Food Focus and Anelich Consulting.

It will be hosted by professor Lucia Anelich, director of Anelich Consulting, and Linda Jackson, director of Food Focus.

With 2020’s widespread global disruption because of the COVID-19 pandemic, the food industry was not spared. In times of crisis, more than ever, the provision of safe, affordable, and nutritious food is key to supporting health, according to the event organizers. Food safety, food security, the food supply chain, and economic challenges, amongst others are all considerations that merit attention.

“As we approach the end of 2020, there is no better time to reflect on the disruptions and challenges that the COVID-19 pandemic has taught us. The provision of safe, affordable, and nutritious food remains key to supporting health, particularly in times of crisis when food (shortages) are often experienced. Join us as we explore the many challenges that COVID-19 has brought to the food industry, together with opportunities it has created, and lessons learned as we prepare for food safety in 2021.” said professor Lucia Anelich, food safety expert and owner of Anelich Consulting.

This food safety summit is designed to do two things — first is to reflect on the emergency preparedness procedures  used this year. For those who have not had to use them, this gives us the ideal opportunity to review what we have in theory and ensure that we have a feasible solution should it be needed.

“Emergency planning has always been part of a food safety management system, but fortunately we very seldom need to deal with emergency situations on a real basis. . .  until 2020. In an unprecedented year, where we have had to deal with a pandemic, food security issues, a potentially disrupted supply chain, staff wellbeing, and many other real emergency situations, we have been taught a lot about our food safety management systems and where our potential weaknesses are,” says Linda Jackson, founder, and owner of Food Focus.

The second aim of the event is to celebrate industry successes. Though the year has been marred with many disappointments and a great deal of stress, the food industry has been operating in full force as an essential service from Day 1 of lockdown and has proved its resilience and courage, the event announcement said. This summit provides an opportunity to celebrate and to thank the many food safety heroes who have made a difference this year.

“Besides all of this,” add Anelich and Jackson, “achieving our targets for implementing the Sustainable Development Goals of 2030 has perhaps been hampered due to the pandemic and this summit will provide a chance to review our progress to determine whether we are still on track.”

In line with social distancing practices and other safety measures, the event is being held virtually this year but is designed to keep attendees engaged and connected throughout. Presentations, Q&A sessions, and virtual sponsor meetings will be part of the event.

The summit features a line-up of speakers, both international and domestic.

Speakers Include: 

  • Bill Marler, attorney and food safety advocate, MarlerClark
  • Frank Yiannas, Deputy Commissioner, Food Policy and Response – U.S. FDA
  • Wayne Anderson, Director of Food Science, and Standards – Food Safety Authority of Ireland
  • Kalmia Kniel, President – International Association for Food Protection
  • Dawie Roodt, chief economist – Efficient Group
  • Kaarin Goodburn, secretary – Chilled Food Association
  • John Donaghy, head of Food Safety (Microbiology/Allergens) Corporate Operations – Quality
    Management – Société des Produits Nestlé S.A.
  • Professor Lucia Anelich – Anelich Consulting
  • Elsabe Mathee, FSSC Foundation
  • Richard Swannell, WRAP
  • Linda Jackson, Food Focus
  • Gerhard Neethling, Red Meat Industry Forum
  • Lianne Jones, Country Manager South Africa – Produce Marketing Association
  • Matlou Setati, FSI Executive – Consumer Goods Council of South Africa
  • Jane Nock, In2Foods
  • Karin Carstensen, regulatory affairs – Woolworths
  • Professor Leon Gorris, independent food safety expert – Food Safety Futures
  • Proffessor Michelle Danyluk, food science – The University of Florida
  • Professor Ryk Lues, Director – CAFSaB, CUT
  • JP. v. Lewinski, AIG Global Insurers
  • Kevin O’Brien, risk executive – SPAR Group

To register for the event, visit https://foodsafetysummit.co.za/

For assistance, send email to: events@foodfocus.co.za 

Over the years, I have had a disagreement or two with the CDC, but I never, ever thought for a moment that the premier public health agency in the world was anything less than that.  Everyone interested in any aspect of public health, and specifically the COVID-19 pandemic should read the letter below.

From the pages of The Washington Post as first reported by USA Today:

WILLIAM FOEGE, a legendary figure in public health who helped devise the strategy that curtailed smallpox in West and Central Africa in the late 1960s and who led the Centers for Disease Control and Prevention under Presidents Jimmy Carter and Ronald Reagan, wrote a letter Sept. 23 to the current CDC director, Robert Redfield. The letter has now been disclosed by USA Today and should be read by everyone concerned by President Trump’s dreadful response to the coronavirus pandemic and his corrosive politicization of public health.

Foege-Letter

It is true, “Everything Tump Touches, Dies”.

Peaches sicken at least 126 in the US and Canada – Onions sicken at least 1,527 in the US and Canada

Wawona Packing Peaches: The FDA and CDC reported that as of August 27, 2020, a total of 78 people infected with the outbreak strain of Salmonella Enteritidis have been reported from 12 states. Illnesses started on dates ranging from June 29, 2020, to August 3, 2020. Ill people range in age from 1 to 92 years, with a median age of 44. Sixty-four percent of ill people are female. Of 67 ill people with available information, 23 hospitalizations have been reported. No deaths have been reported.

Whole genome sequencing analysis shows that an outbreak of Salmonella Enteritidis infections in Canada is related genetically to this outbreak in the United States. This means that people in both of these outbreaks are likely to share a common source of infection.

As of September 2, 2020, there have been 48 confirmed case of Salmonella Enteritidis illness linked to this outbreak in two provinces: Ontario (32) and Quebec (16). Individuals became sick between June and August 2020. Eleven individuals have been hospitalized. No deaths have been reported. Individuals who became ill are between 0 and 91 years of age. The majority of cases (58%) are female.

Epidemiologic evidence indicates that peaches are the likely source of this outbreak. This investigation is ongoing to identify other retailers that may have sold contaminated peaches packed or supplied by Prima Wawona or Wawona Packing Company LLC.

Thomson International Onions: The FDA and CDC reported that as of August 31, 2020, a total of 1,012 people infected with the outbreak strain of Salmonella Newport have been reported from 47 states. Illnesses started on dates ranging from June 19, 2020, to August 11, 2020. Ill people range in age from less than 1 to 102 years, with a median age of 40. Fifty-seven percent of ill people are female. Of 581 ill people with information available, 136 hospitalizations have been reported. No deaths have been reported.

Whole genome sequencing analysis shows that an outbreak of Salmonella Newport infections in Canada is related genetically to this outbreak in the United States. This means that people in both of these outbreaks are likely to share a common source of infection.

In total, there were 515 confirmed cases of Salmonella Newport illness linked to this outbreak in the following provinces: British Columbia (121), Alberta (293), Saskatchewan (35), Manitoba (26), Ontario (14), Quebec (25) and Prince Edward Island (1). Individuals became sick between mid-June and late-August 2020. Seventy-nine individuals were hospitalized. Three people died, but Salmonella did not contribute to the cause of these deaths. Individuals who became ill were between 1 and 100 years of age. The majority of cases (54%) were female.

Epidemiologic and traceback information indicates that red onions are a likely source of this outbreak. Due to the way onions are grown and harvested, other onion types, such as, white, yellow, or sweet yellow, are also likely to be contaminated. The traceback information collected from several of these illness clusters identified Thomson International, Inc., of Bakersfield, California, as a likely source of red onions. Due to the way onions are grown and harvested, other onion types, such as white, yellow, or sweet yellow, are also likely to be contaminated. Traceback is ongoing to determine if other onions are linked to the outbreak.

Some would say, why it took so long?

Canada Food Inspection Agency (CFIA) is now requiring testing of romaine lettuce from the Salinas Valley, but not from Yuma.

Romaine lettuce imported from the United States has been associated with several outbreaks of foodborne E. coli O157:H7 illnesses in Canada and the USA. Food safety investigations and trace-backs from U.S. authorities have identified a recurring geographical area as the source of the outbreaks. This area encompasses the California Salinas valley counties of Santa Cruz, Santa Clara, San Benito and Monterey.

Due to the reoccurring nature of the outbreaks in Canada the CFIA is implementing temporary import conditions for romaine lettuce originating from these growing areas. This import requirement will require importers of romaine lettuce from the implicated regions in the USA to provide a Certificate of Analysis for each shipment to demonstrate that the product does not contain detectable levels of E. coli O157:H7. This measure is in effect for all shipments arriving in Canada between October 7 and December 31, 2020.

The CFIA will allow the importation of romaine lettuce from the USA if:

  • the importer has a valid Safe Food for Canadians license
  • the importer indicates the geographical origin of the romaine lettuce
  • romaine lettuce grown in California has been handled by a certified member of the California LGMA
  • romaine lettuce grown in Arizona has been handled by a shipper that is a certified member of the Arizona LGMA
  • romaine lettuce from the California counties of Santa Clara, Santa Cruz, San Benito and Monterey is accompanied by a certificate of analysis demonstrating that sampling was conducted according to the sampling and testing requirements and the product does not contain detectable levels of E. coli O157:H7
  • if a declaration of origin of the romaine lettuce is not available, a certification of analysis must be provided

Why not Yuma?

As of September 24, 2020, a total of 41 people infected with the outbreak strain of Salmonella Stanley have been reported from 10 states – Arizona, California, Connecticut, Georgia, Illinois, Louisiana, New Jersey, New York City, Pennsylvania and Wisconsin.

Illnesses started on dates ranging from January 21, 2020, to August 26, 2020. Ill people range in age from 2 to 74 years, with a median age of 27. Sixty-two percent of ill people are female. Of 32 ill people with information available, 4 hospitalizations have been reported. No deaths have been reported.

Epidemiologic and traceback information show that wood ear mushrooms distributed by Wismettac Asian Foods, Inc., are the likely source of this outbreak.

The California Department of Public Health collected dried fungus at one of the restaurants linked to an illness cluster for testing. Testing identified Salmonella in a sample of dried fungus distributed by Wismettac Asian Foods, Inc. WGS analysis is being done to determine if the Salmonella identified in the dried fungus is the same as the Salmonella from ill people.

On September 24, 2020, Wismettac Asian Foods, Inc., issued a recallof all Shirakiku imported dried fungus after the California Department of Public Health found Salmonella in the product.

From FDA Press Release from yesterday:

Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more.

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). If finalized, the proposal would standardize the data elements and information firms must establish and maintain, and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability. While limited to only certain foods, this proposal lays the foundation for a standardized approach to traceability recordkeeping, paving the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future. Where possible, FDA has drawn on existing consensus standards that industry members may already be using.

Existing FDA regulations require much of the food industry to establish and maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping). These requirements form a baseline for traceability recordkeeping, but they provide limited information to effectively and rapidly link shipments of food through each point in the supply chain. This — and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry– can make it difficult to trace a product to its original source when necessary.

As a result, many foodborne illness outbreak investigations have been slowed, resulting in more illnesses and economic loss. Improved traceability, as envisioned by the proposed rule, would allow the FDA to more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct more timely root-cause investigations to learn more about how contamination occurred in order to prevent future outbreaks.

At the heart of the proposal is a requirement for those who manufacture, process, pack, or hold a food on the Food Traceability List (FTL) to establish and maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating, and shipping. For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs). Examples of KDEs include the traceability lot code, the date the product was received, the date the product was shipped, and a product description. The traceability lot code is an important KDE throughout the supply chain intended to establish critical linkages that will help to facilitate rapid traceback and traceforward investigations during foodborne illness outbreaks and recall events. In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations.

The proposed rule would require records to be maintained as either electronic, original paper records, or true copies. In addition, the proposal states that in the event of a foodborne illness outbreak, a product recall, or other threat to public health, the FDA could require that firms submit, within 24 hours, an electronic sortable spreadsheet containing relevant traceability information for specific foods and date ranges. More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible, to expedite the identification of traceability information when needed to address threats to public health.

The requirements of the proposed rule would only apply to foods that are on the FTL, which includes foods that have listed foods as ingredients. The proposed rule includes several exemptions, including that the additional traceability records would not be required after a kill-step (a process that significantly minimizes pathogens in a food) is applied to a food, but documentation of the kill-step application would have to be established and maintained.

The proposed rule and draft Food Traceability List are available for public comment for a 120 days from the date of publication. The FDA will also be holding three public meetings during the public comment period. Information about the public meetings will be provided in a forthcoming announcement.

For More Information

Marler Clark, Bainbridge Island, lowered our flag out of respect for Justice Ginsberg.

From the Justice:

My mother told me to be a lady. And for her, that meant be your own person, be independent.

I said on the equality side of it, that it is essential to a woman’s equality with man that she be the decision-maker, that her choice be controlling.

Women will only have true equality when men share with them the responsibility of bringing up the next generation.

The state controlling a woman would mean denying her full autonomy and full equality.

Someone who used whatever talent she had to do her work to the very best of her ability. And to help repair tears in her society, to make things a little better through the use of whatever ability she has.

To do something, as my colleague David Souter would say, outside myself. ‘Cause I’ve gotten much more satisfaction for the things that I’ve done for which I was not paid.

I tell law students… if you are going to be a lawyer and just practice your profession, you have a skill—very much like a plumber. But if you want to be a true professional, you will do something outside yourself… something that makes life a little better for people less fortunate than you.

Real change, enduring change, happens one step at a time.

Fight for the things that you care about, but do it in a way that will lead others to join you.

Women will have achieved true equality when men share with them the responsibility of bringing up the next generation.

A federal court in Texas sentenced ice cream manufacturer Blue Bell Creameries L.P. to pay $17.25 million in criminal penalties for shipments of contaminated products linked to a 2015 listeriosis outbreak, the Justice Department announced today.

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.

“American consumers must be able to trust that the foods they purchase are safe to eat,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division.  “The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”

“The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company,”  said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration.  “Americans expect and deserve the highest standards of food safety and integrity.  We will continue to pursue and bring to justice those who put the public health at risk by distributing contaminated foods in the U.S. marketplace.”

“The results of this investigation reflect the determination of the Defense Criminal Investigative Service to hold companies that sell food products to the military accountable and ensure they comply with food safety laws,”  said Michael Mentavlos, Special Agent-in-Charge of the DCIS Southwest Field Office.  “The health and safety of our service members and their dependents is of paramount importance.”

The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act.  According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems.  Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination.  Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional state-led testing confirmed Listeria in a third product.  Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.

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.

Trial Attorneys Patrick Hearn and Matt Lash of the Civil Division’s Consumer Protection Branch prosecuted the case with assistance from Shannon Singleton and Michael Varrone of the FDA’s Office of Chief Counsel.  The criminal investigation was conducted by the FDA’s Office of Criminal Investigations and the Department of Defense Criminal Investigative Service.

For more information about the enforcement efforts of the Consumer Protection Branch visit its website at http://www.justice.gov/civil/consumer-protection-branch.

“Fight like you live here” was always the tag at the end of any of Tony’s frequent email missiles.

It it is was a great empty feeling of loss that I learned about his death today.  My thoughts to his family and friends.  From Food and Water Watch’s website:

Tony Corbo is the senior lobbyist for the food campaign at Food & Water Watch. He is responsible for food-related legislative and regulatory issues that come before Congress and the Executive Branch. Tony has extensive organizing experience having directed major public employee representation campaigns in several states. He has also directed political campaigns at various levels, and he served as the administrative assistant to a Member of Congress. He holds a Bachelor of Arts degree in Public Affairs from The George Washington University and a master’s degree in industrial and labor relations from Cornell University.

Tony would not need time to think or process – I do – but I will have more to say about a friend who I greatly admired.