Consumer Reports criticizes withdrawal given recent developments that undermine USDA’s ability to protect the public from foodborne illness 

WASHINGTON DC – The USDA’s decision to withdraw its proposed regulatory framework to reduce salmonella illness from poultry is just the latest development at the agency that weakens its ability to respond to foodborne illness outbreaks, according to Consumer Reports. Earlier this year, CR released an analysis detailing the large number of poultry plants with high levels of Salmonella contamination and urged the USDA to strengthen its proposed framework, which sought to keep poultry contaminated with Salmonella above a certain level off the market and subject to recall.

“The USDA’s decision is disappointing and troubling given the large number of poultry plants that have been found to pose a higher risk of triggering a Salmonella outbreak,” said Brian Ronholm, director of food policy at Consumer Reports. “Combined with recent staff and budget cuts, the delay in the implementation of the food traceability rule, and the elimination of critical food safety advisory committees, the administration is sending the message that consumers will be on their own when it comes to protecting their families from foodborne illness.”

Ronholm continued, “Salmonella infections from poultry have increased steadily over the past decade and sicken hundreds of thousands of Americans every year. Consumers deserve better safeguards against Salmonella and other threats to our food supply.”

The USDA’s proposed regulatory framework would have declared any chicken or turkey product as adulterated if they contain any type of Salmonella at or above 10 colony forming units (CFUs)/per millimeter or gram (10 cfu/mL(g)) and if they are contaminated with Salmonella strains of particular health concern for that commodity.

For any chicken product to be considered of public health concern under the proposed standard, it would have to be at or above 10 CFU for any Salmonellaand have detectable levels of the three serotypes: Enteritidis, Typhimurium, and I, 4 [5], 12:i-. For ground turkey to be considered of public health concern, it would have to be above 10 CFU for any Salmonella and have detectable levels of the following three serotypes: Typhimurium, Hadar, and Muenchen.

In its comment letter to the USDA, CR characterized that standard as too lax and urged the USDA to adopt an enforceable product standard for these poultry products that contain any type of Salmonella at 1 cfu/mL(g) as they did for not-ready-to-eat breaded stuffed chicken products.

While Salmonella can be spread through many foods, poultry is a leading source. Chicken alone accounts for more Salmonella infections than any other food category and has been steadily increasing over the past ten years. An estimated 195,634 illnesses are caused by Salmonella contaminated chicken, costing Americans $2.8 billion per year. According to the Centers for Disease Control and Prevention, the incidence of Salmonella illnesses in people increased between 1996 and 2022, going from 14.5 illnesses per 100,000 population in 1996 to 16.3 illnesses in 2022. Typical Salmonella infection symptoms include nausea, vomiting, severe stomach cramps, diarrhea and low-grade fever.

Salmonella contamination is widespread in chicken in part because of the often crowded and filthy conditions in which they are raised. A 2022 CR investigation, for example, found almost one-third of ground chicken samples tested contained Salmonella. Of those, 91 percent were contaminated with one of the three strains that pose the biggest threat to human health: Infantis, Typhimurium, and Enteritidis.

Media contact: Michael McCauley, michael.mccauley@consumer.org

Since the start of the Trump Administration, the CDC and FDA have withheld from the public details about a Romaine Lettuce E. coli O157:H7 outbreak that sickened 89 in 15 states with 36 hospitalized, 7 with kidney failure – hemolytic uremic syndrome –  and 1 death.

(Bainbridge Island, WA – April 21, 2025)  “It is disappointing, but with 20,000 employees at Health and Human Services (HHS) being fired, investigating, and reporting on outbreaks and alerting the public to the cause is clearly not a priority for this administration.  If the gutted CDC and FDA can no longer do the job, we will step up to inform and protect the public – so much for ‘Make America Healthy Again (MAHA),’” said William “Bill” Marler.  See,Marler Blog post: “CDC and FDA ‘Romaine’ Silent.”

In November 2024, the CDC and FDA began an investigation into an outbreak of E. coli O157:H7. By the time the CDC and FDA closed the investigation in January 2025, and reported it February 5, 20205, the outbreak included 89 people across 15 states: AR (2), CO (1), IL (7), IN (8), KS (1), KY (1), MO (50)[1], MT (1), ND (2), NE (3), OH (8), PA (1), SD (1), TN (1), WI (2). Onset dates ranged from November 4, 2024, to November 30, 2024. Ages ranged from 4 to 90 years, with a median age of 24. Outcome information was available for 74 cases, of which 36 (49%) were hospitalized. There were 7 reported cases of HUS, and 1 death attributed to the outbreak. All cases were linked by whole genome sequencing (WGS) to each other.[2] See NCBI WGS Tree of Outbreak Cases.

According to documents reviewed, 7 subclusters of illnesses were identified across the multistate outbreak. These included 3 MO catered events, an OH secondary school, an IN restaurant, an IL restaurant, and an IL event catered by a different MO-based caterer. Salads were the common link across all 7 subclusters, and cases in all subclusters ate a romaine lettuce blend. At the time, based on information available at the points of service (POS), the traceback focused on romaine lettuce.

The CDC and FDA investigation consisted of three traceback legs representing twenty-eight cases and five POS. The three traceback legs identified four distribution centers, one broker, two processors, one grower, and one ranch – all names redacted in the documents. The traceback investigation determined that a sole processer sourced romaine lettuce from a single grower that would have been available at all points of service during the timeframe of interest. Additionally, romaine lettuce supplied to four of the five POS were traced back to the common ranch and lot. Through analysis of records, four lots of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the outbreak vehicle. Epidemiologic and traceback data supported the conclusion that romaine lettuce was the source of illnesses in the outbreak. The CDC and FDA closed the investigation on January 15, 2025, with the confirmed vehicle being romaine lettuce, without alerting the public who was the source of the outbreak. See, CDC Report and FDA Report.

“Because we represent people and families from several states that were WGS matches to each other, it was not long until our on-staff Epidemiologist determined that there was a common link to romaine lettuce in the outbreak period.  Had the CDC and FDA been allowed to do their jobs they would have publicized the conclusion,” said Marler.

William “Bill” Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli O157:H7 Outbreak which was chronicled in the book “Poisoned” and in the recent Emmy Award winning Netflix documentary by the same name. Bill’s work has been profiled in the New Yorker, “A Bug in the System;” the Seattle Times, “30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;” the Washington Post, “He helped make burgers safer, Now he is fighting food poisoning again;” and several others. 

Dozens of times a year Bill speaks to industry and government throughout the United States, Canada, Europe, Africa, China, and Australia on why it is important to prevent foodborne illnesses.  He is a frequent commentator on food litigation and food safety on Marler Blog. Bill is also the publisher of Food Safety News.

To contact Bill, reach out to Julie Dueck at jdueck@marlerclark.com or 1-206-930-4220.

[1] According to the St. Louis Health Department, there were a total of 115 cases, including 13 hospitalizations with two with HUS.

[2] “What is whole genome sequencing (WGS) and why is it pivotal in foodborne illness investigations?”

Since the start of the Trump Administration, the CDC and FDA have withheld from the public details about a Romaine Lettuce E. coli O157:H7 outbreak that sickened 89 in 15 states with 36 hospitalized, 7 with kidney failure and 1 death.

(Bainbridge Island, WA – April 17, 2025) Today, Marler Clark, Inc., PS, The Food Safety Law Firm, filed two Indiana and one Missouri Federal E. coli O157:H7 lawsuits against Taylor Farms on behalf of two children and one adult woman who all suffered hemolytic uremic syndrome (HUS) – acute kidney failure – due to E. coli O157:H7.  In addition, Marler Clark amended five previously filed E. coli O157:H7 lawsuits to include Taylor Farms as being linked to salads catered at a high school in St. Louis, Missouri that sickened over 50. 

“It is disappointing, but with 20,000 employees at Health and Human Services (HHS) being fired, investigating, and reporting on outbreaks and alerting the public to the cause is clearly not a priority for this administration.  If the gutted CDC and FDA can no longer do the job, we will step up to inform and protect the public – so much for ‘Make America Healthy Again (MAHA),’” said William “Bill” Marler.  See, Marler Blog post: “CDC and FDA ‘Romaine’ Silent.”

In November 2024, the CDC and FDA began an investigation into an outbreak of E. coli O157:H7. By the time the CDC and FDA closed the investigation in January 2025, the outbreak included 89 people across 15 states: AR (2), CO (1), IL (7), IN (8), KS (1), KY (1), MO (50)[1], MT (1), ND (2), NE (3), OH (8), PA (1), SD (1), TN (1), WI (2). Onset dates ranged from November 4, 2024, to November 30, 2024. Ages ranged from 4 to 90 years, with a median age of 24. Outcome information was available for 74 cases, of which 36 (49%) were hospitalized. There were 7 reported cases of HUS, and 1 death attributed to the outbreak. All cases were linked by whole genome sequencing (WGS) to each other.[2] See NCBI WGS Tree of Outbreak Cases.

According to documents reviewed, 7 subclusters of illnesses were identified across the multistate outbreak. These included 3 MO catered events, an OH secondary school, an IN restaurant, an IL restaurant, and an IL event catered by a different MO-based caterer. Salads were the common link across all 7 subclusters, and cases in all subclusters ate a romaine lettuce blend. At the time, based on information available at the points of service (POS), the traceback focused on romaine lettuce.

The CDC and FDA investigation consisted of three traceback legs representing twenty-eight cases and five POS. The three traceback legs identified four distribution centers, one broker, two processors, one grower, and one ranch – all names redacted in the documents. The traceback investigation determined that a sole processer sourced romaine lettuce from a single grower that would have been available at all points of service during the timeframe of interest. Additionally, romaine lettuce supplied to four of the five POS were traced back to the common ranch and lot. Through analysis of records, four lots of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the outbreak vehicle. Epidemiologic and traceback data supported the conclusion that romaine lettuce was the source of illnesses in the outbreak. The CDC and FDA closed the investigation on January 15, 2025, with the confirmed vehicle being romaine lettuce, without alerting the public that Taylor Farms[3] was the source of the outbreak. See, CDC Report and FDA Report.

“Because we represent people and families from several states that were WGS matches to each other, it was not long until our on-staff Epidemiologist determined that the common link was that all clients consumed Taylor Farms romaine lettuce in the outbreak period.  Had the CDC and FDA been allowed to do their jobs they would have publicized the same conclusion,” said Marler.

See, complaints: Carnaghi, Graham, Mujkanovic, Swearington, Everding, George, Hasenour and Hefling.

William “Bill” Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli O157:H7 Outbreak which was chronicled in the book “Poisoned” and in the recent Emmy Award winning Netflix documentary by the same name. Bill’s work has been profiled in the New Yorker, “A Bug in the System;” the Seattle Times, “30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;” the Washington Post, “He helped make burgers safer, Now he is fighting food poisoning again;” and several others. 

Dozens of times a year Bill speaks to industry and government throughout the United States, Canada, Europe, Africa, China, and Australia on why it is important to prevent foodborne illnesses.  He is a frequent commentator on food litigation and food safety on Marler Blog. Bill is also the publisher of Food Safety News.

To contact Bill, reach out to Julie Dueck at jdueck@marlerclark.com or 1-206-930-4220.

[1] According to the St. Louis Health Department, there were a total of 115 cases, including 13 hospitalizations with two with HUS.

[2] “What is whole genome sequencing (WGS) and why is it pivotal in foodborne illness investigations?”

[3] Taylor Farms was also the source of an onion E. coli O157:H7 outbreak in 2024 that caused 104 illnesses, 34 hospitalizations and 1 death. See, Outbreak Investigation of E. coli O157:H7: Onions (October 2024).

Whole genome sequencing (WGS) is a laboratory process that determines the complete DNA sequence of an organism’s genome at a single time. This includes identifying the order of bases in the DNA molecules (adenine (A), cytosine (C), guanine (G), and thymine (T)) and assembling them to map out all of an organism’s genetic material.

WGS examines the entire genome, covering all the genetic material in the organism, rather than focusing on specific genes or regions. This offers a detailed and complete view of the genome.

Because WGS investigates the entire genome, it provides high-resolution data that can distinguish even slight genetic variations between different strains of an organism.

The process begins with extracting DNA from an organism’s cells. This DNA is then broken into smaller fragments that are sequenced using advanced technologies. The sequences from these fragments are computationally assembled to reconstruct the complete genome sequence.

In public health, it is instrumental in identifying and tracking pathogens in outbreaks of infectious diseases, like foodborne illnesses.

In summary, whole genome sequencing is a powerful tool that provides a complete picture of an organism’s genetic makeup, allowing for in-depth analysis and understanding of its biological functions, evolutionary history, and role in causing diseases.

Whole genome sequencing (WGS) has become a pivotal technology in the investigation of foodborne illnesses due to its capability to provide comprehensive insights into the genetic makeup of pathogens.

WGS allows for precise identification of pathogens at the strain or sub-strain level. This level of detail surpasses traditional methods, enabling investigators to differentiate between closely related strains, which is crucial during outbreak investigations.

By comparing the whole genome sequences of pathogens isolated from different sources, WGS helps trace the source of an outbreak. It can identify the point of contamination along the food supply chain, whether it’s on the farm, processing plant, or point of sale.

WGS can detect and link seemingly sporadic cases by identifying common genetic markers, revealing unrecognized outbreaks. It allows public health officials to compare current strains with those from past outbreaks globally, aiding in pinpointing sources and connections.

WGS can identify genes linked to antibiotic resistance, providing insights into resistance patterns and helping guide treatment options for affected individuals. This data is crucial for managing public health responses and developing regulatory policies.

The detailed genetic information obtained through WGS helps scientists understand the evolution and adaptation mechanisms of pathogens, including mutations and horizontal gene transfer, leading to better risk assessments and prevention strategies.

Integrated WGS-based surveillance systems, like those utilized by public health agencies (e.g., PulseNet in the U.S.), enhance the ability to monitor and respond to foodborne illnesses in real time. The technology supports a shift towards proactive rather than reactive public health responses.

While initially more expensive, advances in WGS technology have made it more cost-effective and faster than many traditional typing methods, allowing for more rapid public health interventions.

Overall, the implementation of whole genome sequencing in foodborne illness investigations represents a transformative step in public health, providing comprehensive and actionable data that enhances the ability to prevent and control outbreaks effectively.

Come on now!

2411MOEXH-2

Closeout Summary

Closeout Date: January 15, 2025

CDC Primary Contact: Angelo Lodato

Classification: Outbreak

Vehicle: Romaine Lettuce

Vehicle Status: Confirmed

Exposure Type: Multistate

Hello Colleagues,

On November 25, 2024, PulseNet coded an outbreak of E. coli O157:H7 2411MOEXH-2. At the time of closing, this investigation included 89 cases across 15 states: AR (2), CO (1), IL (7), IN (8), KS (1), KY (1), MO (50), MT (1), ND (2), NE (3), OH (8), PA (1), SD (1), TN (1), WI (2), all related within 0-4 alleles by cgMLST. Isolation dates ranged from November 7, 2024, to December 1, 2024. Reported onset dates (n=83) ranged from November 4, 2024, to November 30, 2024. Ages ranged from 4 to 90 years with a median age of 24. Sixty of 88 cases (68%) were female. Outcome information was available for 74 cases, of which 36 (49%) were hospitalized. There were 7 reported cases of HUS, and 1 death attributed to this outbreak.

A case in this investigation was defined as infection with E. coli O157:H7 with an isolate related to the outbreak strain within 0-4 alleles by cgMLST and isolation date ranging from November 7 to December 1, 2024.

This outbreak was related to six historical investigations: 2302MLEXH-1, 2210MLEXH-3, 2210MLEXH-2, 2209MLEXH-1, 2112MLEXH-1, and 2106CAEXH-1. The only vehicle identified was for 2112MLEXH-1, which was closed with a confirmed vehicle of organic power greens. The NCBI tree for this strain included numerous nonclinical beef isolates.

This outbreak was coded following notification from colleagues in MO after they identified and investigated multiple illness linked to events catered by the same MO-based caterer. These events occurred between November 6 and November 8. All events included the same menu items with a few modifications. MO colleagues conducted a retrospective cohort study at 2 of the events and found that salads were the only statistically significant menu item across both events. Salads contained an iceberg/romaine lettuce blend, carrots, purple cabbage, onions, canned pimento, canned artichokes, parmesan cheese, and a house made salad dressing.

In total, 7 subclusters were identified across the multistate outbreak. These included 3 MO catered events, an OH secondary school, an IN restaurant, and IL restaurant, and an IL event catered by a different MO-based caterer. Salads were the common link across all 7 subclusters, and cases in all subclusters ate an iceberg/romaine lettuce blend. CDC deployed a focused questionnaire on November 26, 2024; 27 questionnaires were returned. Epi information was available for 65 cases, of which 60 (95%) reported consuming any type of leafy green prior to illness. Of 57 cases who could remember the exact type of leafy green consumed, 50 (88%) consumed romaine lettuce. This is statistically significantly higher than the background rate of 49% from the FoodNet Population survey. 

A traceback investigation was initiated in response to an E. coli O157 outbreak with leafy greens as the suspected vehicle. Each case included in the traceback investigation reported consumption of leafy greens prior to illness onset. Based on information available at the points of service (POS), the traceback focused on iceberg and romaine lettuce. The investigation consisted of three traceback legs representing twenty-eight cases and five POS. The three traceback legs identified four distribution centers, one broker, two processors, one grower, and one ranch. The traceback investigation determined that a sole processer sourced romaine lettuce from a single grower that would have been available at all points of service during the timeframe of interest. Additionally, romaine lettuce supplied to four of the five POS was traced back to a common ranch and lot. Through analysis of records, four lot of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the vehicle. 

Epidemiologic and traceback data supported the conclusion that romaine lettuce was the source of illnesses in this outbreak. CDC closed this investigation on January 15, 2025, following the elapsing of the surveillance reporting lag period and lack of new uploads. CDC closed this investigation as an outbreak with a confirmed vehicle of romaine lettuce. This outbreak will be reported to NORS with NORS ID: 511856.

Thank you all for your help with this investigation!

Here is what I have been able to get from the CDC and FDA to date:

https://www.marlerblog.com/files/2025/04/2411MOEXH-2-Romaine-CO-DPHE-Records.pdf

https://www.marlerblog.com/files/2025/04/2411MOEXH-2-Romaine-E.-coli-FDA-Records.pdf

I am a firm believer that people and companies can change and improve after doing something horrible, but what happened should not be ignored. the International Daily Foods Association – and Blue Bell should not forget. Here is a bit of a reminder.

The Award:

Blue Bell Creameries of Brenham, Texas was recognized today with the International Dairy Foods Association’s (IDFA) 2025 Food Safety Leadership Award during IDFA’s Dairy Forum. The award, now in its ninth year, honors an individual, group or organization for demonstrating outstanding leadership directed at enhancing food safety within the dairy products industry.

Blue Bell Creameries has been a premier ice cream and frozen dessert maker for 118 years. Established as the Brenham Creamery Company in 1907, the company changed its name to Blue Bell Creameries in 1930 after the native Texas bluebell wildflower. Today, Blue Bell products are available in nearly half the states in the country and rank as one of the best-selling ice creams in the United States. Over the past decade, the company has transformed itself by implementing one of the dairy industry’s most rigorous food safety protocols and quality assurance programs, going beyond regulatory and industry standards to set one of the highest bars in dairy.

“IDFA is pleased to present the 2025 Food Safety Leadership Award to Blue Bell Creameries and to recognize the company’s strong commitment to embracing a ‘culture of food safety’ across the entire business, in all employees, in all aspects of its work,” said IDFA Senior Vice President for Regulatory and Scientific Affairs Roberta Wagner, one of the panelists who reviewed this year’s nominees.

In addition to testimonials from third-party industry experts, Wagner said it was the company’s investment and commitment to ongoing food safety training for staff that elevated Blue Bell.

“Food safety systems, protocols, and data are essential, but nothing is more important than rigorous and consistent training for all staff,” said Wagner.

“This award is a reflection of the hard work and dedication of an entire team that shares a common goal. Together, Blue Bell has built and embraced a culture over the years where food safety is not just a priority, but a fundamental value that shapes everything we do. We are proud to be a part of IDFA, and to share in their commitment to working together to make a positive difference for the dairy industry and consumers,” said Jimmy Lawhorn, President, Blue Bell Creameries.

Blue Bell has developed and implemented comprehensive training programs on food safety for all staff, conducts rigorous internal audits, and is BRCGS-certified at all three of the company’s main production facilities since 2021, receiving the highest possible scores in each of the past two years. Additionally, the company has invested in new equipment with enhanced sanitary design, implemented new software and data solutions, upgraded its facilities, and established a robust ingredient screening and approval program.

The Outbreak:

A total of 10 people infected with several strains of Listeria were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015. The people with illness onsets during 2010–2014 were identified through a retrospective review of the PulseNet database for DNA fingerprints matching isolates collected from Blue Bell ice cream samples. All 10 (100%) people were hospitalized. Three deaths were reported from Kansas.

Investigation of the Outbreak

February 2015

In February 2015, the South Carolina Department of Health and Environmental Control isolated Listeria as part of routine sampling from Blue Bell brand single-serving ice cream products collected from a distribution center: Chocolate Chip Country Cookie Sandwiches and Great Divide Bars. In response to the findings in South Carolina, the Texas Department of State Health Services collected product samples from the Blue Bell Creameries production facility in Brenham, Texas, that made these products. Testing by Texas health officials yielded Listeria isolates from some samples of the same two products tested by South Carolina and from another Blue Bell ice cream product called “Scoops.” This product was made on the same production line as the Chocolate Chip Country Cookie Sandwiches and Great Divide Bars. PFGE was performed on the Listeria isolated from the ice cream samples; seven different PFGE patterns were identified and uploaded to PulseNet.

March 2015

In March 2015, Kansas health officials identified two people from the same hospital who were infected with Listeria bacteria that had the same PFGE pattern. Three additional listeriosis cases with three other PFGE patterns had previously been identified from the same hospital. All five people were hospitalized for unrelated problems before developing invasive listeriosis — a finding that strongly suggested their infections were acquired in the hospital. Listeria isolates from four of the five people had PFGE patterns that were also identified in ice cream tested by South Carolina and Texas. Although some of the illnesses occurred more than a year before this investigation began, all four people with available information consumed milkshakes made with the “Scoops” Blue Bell ice cream product while they were in the hospital. Isolates from four of these people were highly related to each other by whole genome sequencing. Listeria isolated from the fifth person was not related to isolates from the other four ill people. In addition, the PFGE pattern was not identified in any ice cream samples. However, this person was part of a recognized illness cluster at the hospital and consumed milkshakes made with “Scoops” while hospitalized. As a result, this person was included as a case in the outbreak.  Illness onset dates for the five people ranged from January 2014 through January 2015. Three of these people died as a result of their Listeria infection.

On March 13, 2015, Blue Bell Creameries reported removing the “Scoops” ice cream product and other products made on the same production line from the market. The company also reported that it had shut down that production line at its Brenham, Texas, facility.

On March 22, 2015, the Kansas Department of Health and Environment (KDHE) reported that Listeria was isolated from a previously unopened, single-serving Blue Bell brand 3 oz. institutional/food service chocolate ice cream cupcollected from the Kansas hospital involved in the outbreak. Samples of Blue Bell brand 3 oz. institutional/food service chocolate ice cream cups collected from the company’s Broken Arrow, Oklahoma, facility also yielded Listeria. Listeria isolated from ice cream cup samples were indistinguishable from each other by PFGE, but were different from those isolated from people in Kansas and from other Blue Bell brand ice cream products previously sampled in Texas and South Carolina. On March 23, 2015, Blue Bell announced a recall of 3 oz. institutional/food service ice cream cups (with tab lids) of several flavors produced at the company’s Broken Arrow, Oklahoma, facility.

April 2015

On April 3, 2015, CDC reported that illnesses might be linked to ice cream made in Blue Bell Creameries’ Oklahoma facility, but lacked sufficient information to include them as cases in the outbreak at the time. These illnesses were identified when investigators searched the PulseNet database and identified 6 people from Arizona (1), Oklahoma (1), and Texas (4) with listeriosis between 2010 and 2014 who had Listeria isolates with PFGE patterns indistinguishable from isolates from the chocolate ice cream cups made in the Broken Arrow, Oklahoma, facility. The four people reported from Texas were hospitalized for unrelated problems before developing listeriosis. Information available for one person indicated that they consumed ice cream in a Texas hospital before developing listeriosis; the Texas Department of State Health Services reported that the hospital had received Blue Bell brand ice cream cups. None of the four people in Texas died from Listeria infection. At this point in the investigation, CDC recommended that consumers not eat and institutions and retailers not serve any products made at the company’s Oklahoma facility, in addition to any previously recalled or withdrawn products. That day, Blue Bell Creameries reported that they had voluntarily suspended operations at their facility in Oklahoma.

On April 8, 2015, CDC reported that whole genome sequencing confirmed that three of the four isolates from people in Texas were nearly identical to Listeria strains isolated from ice cream produced at Blue Bell Creameries’ Oklahoma facility. These three people were added to the case count for the outbreak, bringing the total to 8. The fourth isolate was later determined not to be part of the outbreak by whole genome sequencing and this illness was not added to the case count.

On April 20, 2015, Blue Bell Creameries voluntarily recalled all products currently on the market made at all of its facilities, including ice cream, frozen yogurt, sherbet, and frozen snacks. Blue Bell announced this recall after sampling by the company revealed that Chocolate Chip Cookie Dough Ice Cream half gallons produced on March 17, 2015, and March 27, 2015, contained Listeria.

On April 21, CDC reported that whole genome sequencing confirmed that the people from Arizona (1) and Oklahoma (1) were part of the outbreak, bringing the total case count to 10.

May 2015

On May 7, 2015, FDA released the findings from recent inspections at the Blue Bell production facilities in Brenham, Texas; Broken Arrow, Oklahoma; and Sylacauga, Alabama.
 
The Criminal Penatly

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.   

This afternoon, the Minnesota Department of Health (MDH) sent layoff and separation notices to 170 employees whose positions were funded by recently terminated federal grants. Additionally, “at risk” notices will be going to MDH staff at risk for layoffs due to seniority rules around layoffs. An estimated 300 notices are going to MDH employees today. Additionally, nearly 20 employees slated to start with the department in the last week have had their offers rescinded.  

These layoffs and separations are a direct consequence of the unprecedented and unexpected action by the federal government last week to cut more than $220 million in previously approved federal funding. These layoffs and separations will impact services across the agency that Minnesotans rely on, including those that support the state’s response to measles and H5N1, wastewater surveillance, the state’s public health laboratory, and community clinics and vaccination efforts.  

“We are working now to figure out how much of this critical public health work we can save and continue,” said Minnesota Commissioner of Health Dr. Brooke Cunningham. “The sudden and unexpected action from the federal government left us with no choice but to proceed with layoffs immediately. It is devastating to be forced to reduce critical services and give notices to so many dedicated public health professionals because the federal government decided to renege on its commitment to our state. They left us in the lurch, with no advance notice, no close-out period, halting work that would have helped us address chronic gaps in the system and be better prepared for future threats.”

The impact of these cuts to our public health system also include:

  • Significantly reduced support for nursing homes, including funding for HVAC upgrades and staff training around disease prevention, as well as support for county jails and other congregate settings.  
  • Slower response times to infectious disease outbreaks.  
  • Immediate suspension of partner-led vaccine clinics and emergency preparedness activities.  
  • Reduced laboratory support for hospitals and health care systems that could delay lab results and patient care.  
  • An inability to upgrade the Minnesota Immunization Information Connection, the state’s immunization information system, which means it will remain outdated.  
  • Suspension of the INSPIRE Program, a program to get middle and high school students excited about and interested in public health.  
  • Reduced funding for Tribal Public Health.

Minnesota Department of Health (MDH) epidemiologists oversee a team of 8 to 10 interviewers (“Team Diarrhea”) who are part-time MDH employees hired  from a pool of MPH students at the University of Minnesota, School of Public Health. 

Each student works approximately 20 hours per week. Team Diarrhea’s hours of operation are Monday through Thursday, 9 a.m. to 8:30 p. m.; Friday, 9 a.m. to 5 p.m.; and Sunday 4 p.m. to 8 p.m. Scheduling night and weekend hours for interviewers increases the likelihood that cases will be able to be reached for interview.

Team Diarrhea was first formed in 1995. From 1999 through 2022, a total of 215 students have worked as part of Team Diarrhea.