On Sept. 5, 2023, the firm was notified by the South Carolina Department of Health and Environmental Control (SCDHEC) that their Not Fried Chicken ice cream treat tested positive for Listeria monocytogenes. The firm also recalled their Life Is Peachy Ice Cream treats because both products were manufactured in the same room.

These products were packaged in lamented buckets and plastic wrap and shipped to Georgia, Illinois, Maryland, North Carolina, New York, South Carolina and Texas distribution centers. The product was also shipped online directly to consumers located in all fifty states plus the District of Columbia.

Recalled products:

As of the posting of this recall, no illnesses have been reported to date.

Consumers who have purchased these products are urged not to consume them and to return the products to the place of purchase for a full refund or they may discard the product. 

About Listeria infections

Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.)

The ice cream, made by Real Kosher Ice Cream of Brooklyn, NY, has been found to be contaminated with the same strain of Listeria monocytogenes as that found in samples from two patients. Both patients, one in New York and the other in Pennsylvania, have been so sick that they required hospitalization.

The company issued a recall of certain ice cream products earlier this month after a link was established between the sick people and its products.

In information released yesterday, the FDA confirmed that Listeria Monocytogenes matching the sick people’s samples was found in an unopened sample of the implicated ice cream during testing by the Pennsylvania Department of Agriculture.

Also, the New York Department of Agriculture and Markets found the outbreak strain of Listeria Monocytogenes in five finished samples of “Soft Serve On the Go” ice cream cups collected from the company’s manufacturing facility.

The ice cream was distributed in California, Colorado, Connecticut, Washington D.C., Delaware, Florida, Illinois, Massacheassetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Virginia and West Virginia.

The company is recalling all flavors of its Soft Serve On The Go 8-ounce ice cream cups”

• Soft Serve On The Go Vanilla Chocolate 
• Soft Serve On The Go Razzle
• Soft Serve On The Go Caramel 
• Soft Serve On The Go Parve Vanilla Chocolate
• Soft Serve On The Go Sorbet Strawberry Mango
• Soft Serve On The Go Lite Peanut Butter

The FDA is continuing to investigate the outbreak along with state officials and the U.S. Centers for Disease Control and Prevention. 

Additional patients are likely part of the outbreak because of the lag time between when people become ill and when testing, confirmation testing and reporting are done. Also, it can take up to 70 days for symptoms of Listeria infections to develop. 

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the recalled ice cream and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News,click here)

A recall in the United States triggered this recall. The U.S. recall resulted from an individual becoming ill and reporting to have eaten this product. Pennsylvania Department of Agriculture tested samples of product and one sample tested positive for Listeria monocytogenes.

As of the posting of the U.S. recall, two cases of illness have been reported in this outbreak in New York and Pennsylvania. Both individuals were hospitalized, but no deaths have been reported to date.

According to the Canadian Food Inspection Agency (CFIA), the products were distributed in Ontario and Quebec, Canada.

Recalled products:

Consumers should not consume, serve, use, sell or distribute recalled products. Recalled products should be thrown out or returned to the location where they were purchased.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled ice cream and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about possible Listeria exposure.

As of the posting of this recall, no reported illnesses have been associated with consuming these products in Canada.

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and cancer patients with weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

Also, anyone who has eaten recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

(To sign up for a free subscription to Food Safety News, click here.)

The recall is the result of an individual becoming ill and reporting to have eaten this product. Pennsylvania Department of Agriculture tested samples of product and one sample tested positive for Listeria monocytogenes.

As of the posting of this recall, two cases of illness have been reported in this outbreak in two states, New York and Pennsylvania. Both individuals were hospitalized but no deaths have been reported to date.

“Soft Serve on the Go Cups” were distributed in the states of California, Colorado, Connecticut, Washington D.C., Delaware, Florida, Illinois, Massacheassetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Virginia and West Virginia.

The recalled product reached consumers through canteens, grocery and convenience stores and more.

The recalled product is packaged in 8-ounce, clear plastic cups. The product looks like a soft serve cup served in an ice cream store, with a clear plastic cover with a seal and spoon attached to it.

Recalled products:

The UPC is the only identifiable code on the package. It does not have any LOT number or best by date. All product produced up to Aug. 4 is being recalled.

The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

Consumers should discontinue consumption of the product immediately. Please dispose of this product or return it for full credit. 

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled ice cream and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled product should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.)

It is also the last of all civil and criminal litigation resulting from the historic 2015 listeriosis outbreak, which found illnesses and deaths from the past associated with the iconic Texas ice cream.

The now-executed plea deal saw Kruse’s agreement to pay a $100,000 monetary penalty for pleading guilty to the sole count of introducing adulterated foods into instate commerce in exchange for dismissal of all felony charges by federal prosecutors.

Federal Judge Robert Pittman entered the final deal in the Western District of Federal Court in Texas in August on March 28. He sentenced Kruse to pay the $100,000 monetary penalty and dismissed the felony charges against Kruse.

“We have said from the very beginning that a misdemeanor was the appropriate result in this case, Mr. Kruse never intended to defraud anyone,” said Houston defense attorney Chris Flood. The Kruse attorney pointed out that last summer’s jury trial “resulted in a hung jury with 10 jurors voting for not guilty.”

Flood said the sentence that has been entered “shows that you can stand up to the government and the truth will prevail.”

Kruse plead guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act, the same charge that Blue Bell as a corporation pleaded guilty to in 2020.

Conspiracy and fraud charges that were brought to a jury trial in August 2022 were not convincing to most jurors. The government only persuaded a couple of jurors that anyone at Blue Bell intended to defraud someone.

In the 2015 listeriosis outbreak, 10 people were sickened and three died.

The 10 confirmed patients were from four states – Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). They all required hospitalization.

During a crisis of more than 60 days in 2015, Kruse ultimately recalled all Blue Bell products and closed its production facilities in Texas, Oklahoma, and Alabama.

But Kruse did not act fast enough for government prosecutors who at the trial said disclosures of the listeriosis problem were withheld from customers and the public for too long.

Through “retrospective review,” the Centers for Disease Control and Prevention (CDC) found isolates collected from Blue Bell ice cream that matched illnesses with onset dates from 2010 to 2014.

This historic Pulsenet data for DNA “fingerprints” including three previous deaths in Kansas where listeriosis was a factor, all occurred before Blue Bell knew of the outbreak in early 2015.

While no one is going to jail, the government with this latest $100,000 has collected a pretty penny from Blue Bell-related contributions.

As a corporate entity, Blue Bell pleaded guilty in a related case in 2020 to two counts of distributing adulterated food products in violation of the Federal Food, Drug, and Cosmetic Act.

The company agreed to pay criminal penalties totaling $17.5 million and $2,1 million to resolve False Claims Act allegations regarding ice cream products manufactured under unsanitary conditions and sold to facilities, including four federal facilities including the military. At that time the total $19.35 million in fines, forfeiture, and civil settlement payments was the second-largest amount ever paid in resolving a food safety matter.

Kruse was the only person charged with individual criminal charges linked to the 2015 outbreak.

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Big Olaf Creamery LLC dba Big Olaf
Sarasota, FL

A food firm in Florida is on notice from the FDA after a facility inspection prompted by a multistate outbreak of Listeria monocytogenes infections linked to ice cream supplied by Big Olaf Creamery LLC’s facility.

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.

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According to the information released by the FDA, the recall was initiated on April 4, 2022. Consumers may still have some of the ice cream on hand because of its long shelf life.

The recalled products were distributed in Arizona, California, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New Mexico, Nevada, Ohio, Oklahoma, Texas and Wyoming.

Recalled Product:

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The Centers for Disease Control and Prevention reports there were 28 patients across 11 states. Of those patients, 27 were hospitalized, one died and one pregnant woman miscarried.

Sick people’s samples were collected from Jan. 24, 2021, to Aug. 19, 2022. Patients’ ages ranged from less than 1 to 92 years old. The last known illness onset was June 24, 2022.

Big Olaf Creamery of Sarasota, FL, recalled all of its ice creams on July 13. Its facilities were closed down by the Florida Department of Health with the assistance of the Florida Department of Agriculture & Consumer Services.

Florida officials found 16 of 17 flavors of Big Olaf ice cream were contaminated with Listeria monocytogenes. They also found the pathogen in production equipment at the company’s factory.

The state department of agriculture performed whole genome sequencing on samples collected from the finished product and equipment and they matched samples from outbreak patients.

Complete distribution details were not available for the ice cream, but most of it was sold at retail in Florida. Some were served to consumers in restaurants and in senior homes, as well as one location in Fredericksburg, OH, according to the FDA. Some sick people reported traveling to Florida and eating ice cream before becoming ill.

States with patients were: Colorado with 1, Florida with 14, Georgia with 1, Illinois with 1, Kansas with 1, Nebraska with 1, Massachusetts with 2, Minnesota with 1, New Jersey with 1, New York with 4, and Pennsylvania with 1.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has developed symptoms of Listeria infection should seek medical treatment and tell their doctors about possible Listeria exposure.

Also, anyone who has eaten any suspect products should monitor themselves for symptoms during the following weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here)

The Food and Drug Administration along with the Centers for Disease Control and Prevention and Florida state officials have been investigating an outbreak of infections from Listeria monocytogenes for months. The culprit was found to be ice cream from Big Olaf Creamery in Sarasota, FL.

As of Nov. 2 the CDC declared the outbreak over with 28 people sick, 27 hospitalized, one death, and one miscarriage. Health officials found the outbreak strain of Listeria in finished ice cream produced by Big Olaf and in equipment at its plant. The business was closed down by state officials.

In a different outbreak involving E. coli O157:H7 from an unknown source, the patient count has increased to 11, up from 10 reported a week ago. The Food and Drug Administration is continuing to investigate the outbreak. It has initiated traceback efforts but has not revealed what food or foods are being traced.

Other ongoing outbreak investigations

• For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. Recall information was updated on Oct. 28. It reported that seven patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
• The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states. At least 20 people had been confirmed sick as of Oct. 7. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio, and Wisconsin. The most recent illness onset was Sept. 13.
• An outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

(To sign up for a free subscription to Food Safety News, click here)

One patient died and a pregnant woman miscarried after eating the ice cream. Of the 25 original patients, 24 required hospitalization. Illnesses were reported in 11 different states. Patients have been identified in Colorado with 1, Florida with 13, Georgia with 1, Illinois with 1, Kansas with 1, Nebraska with 1, Massachusetts with 2, Minnesota with 1, New Jersey with 1, New York with 2, and Pennsylvania with 1.

Other listeria-linked problems this year included the ongoing Blue Bell trial in Texas, and recalls at Royal Ice Cream, Kingdom Creamery and Greenwood Ice Cream. Food Safety News, recognizing the scope of the outbreaks and the need to identify better preventative production practices, asked EAS Consulting Group to develop a free webinar. The webinar is scheduled for Oct. 25 at 1 p.m. EDT. It will cover:

Current information and data on the outbreak;
FDA guidance for Ready-to-Eat foods;
 Listeria mitigation and control; and
Environmental monitoring best practices.

The webinar will be led by Dr. Kathy Knutson, a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation. 
Dr. Knutson has a Ph.D. in Food Science from the University of Minnesota and worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

To register for this free webinar, click here: https://easconsultinggroup.com/listeria-monocytogenes-in-ice-cream-and-frozen-novelties/

The agency is currently investigating 10 outbreaks. The investigations are at various stages, with traceback, on-site inspection and sample collection and analysis ongoing in several of them.

New this week is the announcement that traceback has begun in a Listeria monocytogenes outbreak, but the FDA is not saying what food or foods are being traced. The cause of the outbreak remains unknown. As of Sept. 21 there are six confirmed patients in the outbreak, but the FDA has not revealed where the patients live.

As with the Listeria monocytogenes outbreak, the FDA has not revealed any patient information such as ages or where they live for any of the other outbreaks under investigation.

Ongoing outbreak investigations

• The patient count in an outbreak caused by Salmonella Mississippi has increased to 103 from the 102 patients reported a week ago. The agency has not made public where the patients live or their ages. The FDA has not identified a source of the pathogen but has initiated traceback efforts. The agency has not reported what food or foods are being traced.
• For a Salmonella Senftenberg outbreak from a not yet identified food, the patient count has increased to 30, up from 27 reported a week ago. Traceback has begun but FDA has not reported what is being traced.
• For a Salmonella Typhimurium outbreak from a not yet identified food, the patient count has increased to 84, up from 78 reported a week ago. Traceback, on-site inspection and sample analysis has been initiated, but the FDA has not reported what is being traced or tested or where the inspection is taking place.
• For a Cyclospora outbreak the patient count has increased to 81, up from 79 a week ago. Traceback has begun but the FDA has not reported what is being traced.
• For another Cyclospora outbreak the patient count has remained steady at 42. Traceback has begun but the FDA has not reported what is being traced. Similarily, sample testing has begun but the agency has not reported what is being tested. 
• An investigation related to adverse effects associated with Daily Harvest brand frozen Leeks & Lentils Crumbles is ongoing. The company has received more than 470 complaints of illnesses and as of its most recent report on Sept, 15 the FDA had received 386 complaints. Some of the patients have gone into liver failure and at least 25 have had to have their gallbladders removed. The FDA is working on traceback efforts and has begun on-site inspection and product testing. Some testing has revealed that tara flour is an ingredient unique to the Daily Harvest crumbles product and could be related to the illnesses.
• In an ongoing outbreak of infections caused by E. coli O157:H7 the FDA has initiated sample collection and analysis. The outbreak, reported by the CDC as being linked to lettuce on Wendy’s sandwiches, has sickened at least 84 people. The four-state outbreak has sickened more people according to the state counts, but all of the reports have not reached the CDC. Wendy’s has stopped serving the romaine-iceberg lettuce hybrid on sandwiches in several states, according to a statement from the company.
• The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
• An outbreak of infections from Cronobacter in four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

(To sign up for a free subscription to Food Safety News, click here)

The recall was initiated on July 29 and is ongoing. There is concern that some products may be in consumers’ freezers.

The recalled products were distributed in Vermont, Maine and Massachusetts.

Recalled products:

Consumers should not consume, serve, use, sell or distribute recalled products. Recalled products should be thrown out or returned to the location where they were purchased.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.) 

There are now 25 confirmed patients in the outbreak, according to the Centers for Disease Control and Prevention. Manufactured in Florida and originally thought to only be sold in that state, the agency is reporting that the ice cream was also sold to a location in Fredericksburg, OH.

One patient has died and a pregnant woman miscarried after eating the ice cream. Of the 25 patients, 24 have required hospitalization. Sick people have been reported in 11 different states.

Thirteen of the victims are residents of Florida and 10 reported traveling to Florida in the days before becoming ill. Illness dates range from Jan. 24, 2021, to June 24, 2022. Patients range in age from less than 1 to 92 years old. The CDC has used samples from patients and samples of ice cream along with a national database of strains of Listeria to determine that the sick people are all part of the single outbreak.

Patients have been identified in Colorado with 1, Florida with 13, Georgia with 1, Illinois with 1, Kansas with 1, Nebraska with 1,  Massachusetts with 2, Minnesota with 1, New Jersey with 1, New York with 2, and Pennsylvania with 1. 

Additional patients are likely to be identified because it can take up to 70 days after exposure for symptoms of Listeria infection to develop. Also, it takes three to four weeks for the reporting and testing process to confirm outbreak patients.

All flavors, lots, and expiration dates through 6/30/2022 of Big Olaf brand ice cream products have been recalled. Big Olaf brand ice cream was sold to consumers in plastic pint-size containers and plastic one-half gallon containers. The ice cream was sold to independent retail stores in plastic 2.5-gallon tubs.

State testing by the Florida Department of Agriculture and Consumer Services showed Listeria monocytogenes in the Big Olaf production plant as well as in 16 of 17 flavors of its ice cream. The plant has been shutdown.

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Kruse is the retired president of Blue Bell Creameries who, as an individual, faces federal felony conspiracy and fraud charges over how he handled Blue Bell’s role in a 2015 mysterious outbreak.

Kruse shut down Bell Blue’s multistate production and recalled all its products, but before that, the government says he suppressed and covered up Listeria contamination.

Eighty Texans from West Texas counties answered the call for jury duty. Judge Robert Pitman first warned the jurors that this trial could last three or four weeks. Jurors were first asked if the trial length would cause them hardship. About 20 said it would, citing self-employment, moving, pre-paid vacations, and school starting.

It was primarily a quiet day because jurors were individually questioned “at the bench” for the ears of the judge and one or two attorneys from each side. Any juror who wanted to “approach the bench” with something private was also welcome to do so.

The prospective jurors were all asked if they knew anything about the “2015 Blue Bell recall” and their source for the information. They were then asked if they could still render a fair verdict in the case based only on the evidence they’d hear in court.

Seven years have elapsed between the listeriosis outbreak and this trial. Some jurors did speak up for all to hear. When the government asked if anyone might have a problem with “cooperating witnesses,” some did. One woman said “cooperating witnesses” do so under the threat of themselves being charged, and she could not imagine being under that kind of pressure for seven years.

When the judge asked for a show of hands of those who’ve purchased Blue Bell ice cream, almost all hands went up. About half stayed up when asked if they had Blue Bell in their home freezers now. And close to one-quarter were veterans of the famous Blue Bell plant tour in Brenham, TX.

Today’s opening arguments will likely focus on conspiracy and fraud, the heart of the charges.

Each count coincides with 67 days in the spring of 2015 when Blue Bell was confronting a small but deadly listeriosis outbreak.

The outbreak was one of the first where the federal Centers for Disease Control (CDC) used a retrospective review of the PulseNet database for DNA fingerprints to match isolates collected from Blue Bell ice cream samples.

It found ten people infected with several strains of Listeria from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015. Three people died.

It likely means that by the time the outbreak was known, it had done its damage.  

 Blue Bell Creameries recalled on April 20, 2015, 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.

The Grand Jury indictment of Kruse is based mainly on a half dozen emails from Blue Bell employees. These included:

– 02/19/2015 

According to the indictment, a Blue Bell sales employee by email told a Florida school district ice cream was removed for a problem with a manufacturing machine, “a statement created by Paul Kruse.”

2-23-2015

A restaurant chain asks why ice cream was removed, and a sales staff email also cites a problem with the manufacturing machine.

3-6-2915

Email from a Blue Bell sales employee in Oklahoma City, OK, to Arkansas retail chain failed to disclose certain presumptive positive and confirmed positive for possible Listeria contamination.

03-06-2015

A sales employee’s email to a Wichita, KS, hospital did not disclose that the “Scoops” product was unavailable but did not say it was removed due to potential Listeria contamination.

04-04-2015

A third-party distributor in Maryland asked a Blue Bell sales employee why the Broken Arrow facility was closing without any recall. The sales employee responded in an email that said the FDA had not informed the company of any further positive Listeria tests when additional presumptive positive tests were behind Blue Bell’s decision to close Broken Arrow.

04-07-2015

Email from a Blue Bell quality assurance employee to an Arkansas retail chain fails to disclose confident presumptive positive and confirmed positive Listeria test results.

The company itself pleaded guilty to two counts of distributing adulterated food products in violation of the Federal Food, Drug, and Cosmetic Act.

It paid $19.35 million in fines, forfeitures, and civil settlement payments.  That total was the second largest amount ever paid for the resolution of a food safety matter.

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The facility produces ice cream for Big Olaf Creamery, which has been linked to an outbreak of Listeria infections that has sickened 23 people and killed one. An infected pregnant woman also miscarried.

The Florida Department of Agriculture and Consumer Services (FDACS) earlier this week issued a formal shut down order for the manufacturing plant after 9 of 100 samples from the facility and its equipment tested positive for Listeria monocytogenes. The positive tests at the facility included one from a transfer pipe from pre mix to an ice cream machine.

The positive test results from the ice cream samples were released on the evening of July 15. Documents from the state agriculture department show the samples were collected on July 9. The samples for tests of equipment in the plant were taken on July 7.

Please find linked here [dropbox.com] the results for the product subsamples 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. Click  here [dropbox.com] for those results.

A Seattle food safety attorney who is representing the family of the woman who died after eating the ice cream said he was shocked that 16 of 17 product samples were positive for the deadly pathogen.

“What this shows is that this manufacturing facility had a severe Listeria problem, which shows a sanitation problem,” said attorney Bill Marler. “I am actually shocked that there aren’t more people sick. That could be because more people were not tested.

“The biggest surprise is that the facility and stores stayed open for at least a week after it was known there was a problem. Why didn’t the company shut down? Why didn’t the state shut them down?”

The Florida Department of Health told Food Safety News earlier this week that it has been investigating the Listeria outbreak for more than a year.

The U.S. Centers for Disease Control and Prevention has reported that the first person confirmed as an outbreak patient got sick on Jan. 24, 2021. The most recently confirmed patient became ill on June 12, 2022. Twenty-two of the 23 victims had to be hospitalized. They range in age from 1 to 92 years old and live in 10 different states. Twelve victims live in Florida, and nine report traveling to Florida before becoming ill.

“The true number of sick people in an outbreak is likely higher than the number reported, and the outbreak may not be limited to the states with known illnesses. In addition, recent illnesses may not yet be reported as it usually takes 3 to 4 weeks to determine if a sick person is part of an outbreak,” according to the CDC.

It can take up to 70 days for symptoms of Listeria infection to develop after exposure to the pathogen.

The Florida agriculture department reports that the following flavors of Big Olaf ice cream tested positive for Listeria monocytogenes: 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.

The company has initiated a recall of all of its products. On July 3 owners of Big Olaf posted this statement on the company’s Facebook page:

“For now it is only speculation as it is an ongoing investigation, our brand has not been confirmed to be linked to these cases, am not sure why only Big Olaf is being mentioned and targeted. The original report we got from the Florida Department of Health on Friday July 1st, was that there are 23 cases reported, the first one reported was January 2022. 6 out of the 23 patients mentioned having consumed Big Olaf ice cream, but nothing has been proven. We have been cooperating with the Florida Department of Health, FDACS and the FDA as soon as we were informed about the situation. We have been transparent and have answered all their questions and provided them with all the information requested from us, as the health and well being of the public is our first priority.“

Anyone who has eaten any Big Olaf ice cream and become ill should immediately seek medical treatment, according to the CDC.

The investigation into the outbreak and the situation at the manufacturing plant is ongoing and includes the state agencies as well as the U.S. Food and Drug Administration. 

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalledice creamand developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News,click here)

Big Olaf Creamery of Sarasota, FL is recalling all flavors and all lots of Big Olaf brand ice cream products because of potential Listeria monocytogenes contamination.

Based on epidemiological information shared by the CDC and state officials, Big Olaf may be a potential source of illness in an ongoing Listeria monocytogenes outbreak.

The CDC reported 23 illnesses in 10 states with one person having died. Five pregnant women were reported ill, with one having miscarried.

The sick people live in Colorado, Florida, Georgia, Illinois, Kansas, Massachusetts, Minnesota, New Jersey, New York and Pennsylvania.

“Of the 18 people interviewed, all reported eating ice cream. Among 18 people who remembered details about the type of ice cream they ate, 10 reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery. Twelve sick people are residents of Florida and nine reported traveling to Florida before getting sick,” according to the FDA July 11 update.

The product was sold at Big Olaf retailers in Florida as well as to consumers in restaurants and senior homes, and one location in Fredericksburg, OH.

Recalled products:

• The Big Olaf brand ice cream was sold to consumers in plastic pint size containers, plastic ½ gallon containers, and plastic 2.5-gallon tubs, scoopable are sold to the independent retail stores. 
• All flavors, lots, codes, and all expiration dates through 6/30/2022 are included in this recall.

Big Olaf has requested retailers to stop sales and dispose of the products. 

Consumers who have purchased Big Olaf Ice Cream Products should not consume these products and dispose of them immediately. Any areas, containers, and serving utensils that may have touched the ice cream should be cleaned.

More information from Big Olaf Creamery

On Friday, July 1, 2022, Big Olaf Creamery was informed of an outbreak investigation by the Florida Department of Health and Florida Department of Agriculture & Consumer Services and immediately ceased production and distribution of the ice cream product.

According to the recall, other ice cream brands not related to Big Olaf were mentioned as a possible source as well.

Big Olaf Creamery and all retailers supplied did not receive any complaints regarding product defect or sickness. No formal complaints were filed with the Florida Department of Health as of July 1st, 2022.

About Listeria infections

Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled product and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for the food poisoning symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.)

The Florida Department of Agriculture & Consumer Services (FDACS) is still waiting for results of product sampling, but the evidence of Listeria in the production plant is enough for the state to take action.

Twenty-three people have been infected with Listeria and one has died. One pregnant women suffered a miscarriage.

A spokesman with the Florida Department of Health told Food Safety News today that the agency has been investigating the outbreak for a year.

The agriculture and consumers services department took more than 100 samples at the manufacturing plant of Big Olaf Creamery and nine came back positive, including one from a transfer pipe from pre mix to an ice cream machine. 

“FDACS has issued a stop use order of the processing equipment where the Listeria monocytogenes was found. This will effectively shut down all operations at this processing facility, which had already been done voluntarily by the company,” according to a statement today from the department.

The department is still waiting for another sample to come back from the lab.

Officials from the federal Food and Drug Administration and the Centers for Disease Control and Prevention are also involved in the outbreak investigation.

“Of the 18 people interviewed, all reported eating ice cream. Among 18 people who remembered details about the type of ice cream they ate, 10 reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery. Twelve sick people are residents of Florida and nine reported traveling to Florida before getting sick,” according to the FDA.

Owners of Big Olaf Creamery have consistently denied any connection between their products and the infections.

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In an update of its investigation released today, the agency urges people to not sell or eat any ice cream made by the Florida company. The company issued a recall this past weekend, but the FDA has information that the ice cream may still be on sale at some unnamed locations.

The FDA, along with the U.S. Centers for Disease Control and Prevention, is assisting the Florida Department of Health (FL DOH) and Florida Department of Agriculture & Consumer Services (FDACS) in investigating the outbreak of Listeria monocytogenes infections linked to ice cream supplied by Big Olaf Creamery of Sarasota, FL.

Media in Florida are reporting that state officials there have been investigating the company for a year, with the most recent health inspection having been completed July 6. Jeremy Redfern, a spokesperson for the Florida Department of Health was not available for comment on the situation.

As of June 30, the CDC reported 23 illnesses in 10 states with one person having died. Five pregnant women were reported ill, with one having miscarried.

The sick people live in Colorado, Florida, Georgia, Illinois, Kansas, Massachusetts, Minnesota, New Jersey, New York and Pennsylvania.

“Of the 18 people interviewed, all reported eating ice cream. Among 18 people who remembered details about the type of ice cream they ate, 10 reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery. Twelve sick people are residents of Florida and nine reported traveling to Florida before getting sick,” according to the FDA announcement today.

Owners of Big Olaf Creamery have consistently denied any connection between their products and the infections.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalledproducts and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News,click here)

Big Olaf Creamery owners stated in a Facebook post “that the investigation is ‘only speculation’ ” and it is unclear why the company is being “targeted” after six of 23 patients had mentioned eating their ice cream. “Our brand has not been confirmed to be linked to these cases…”

The U.S. Centers for Disease Control and Prevention announced on Saturday that the company’s ice cream is the likely source of the 23-person outbreak that has killed one woman and resulted in a pregnant woman’s fetal loss. Twenty-two patients have been hospitalized across 10 states.

Some public health entities are under fire from a Seattle food safety attorney who filed the first lawsuit related to the outbreak on behalf of a woman who died in January this year.

“Why a company that knows it is under scrutiny for a deadly Listeria monocytogenes outbreak would ignore the science and put customers at risk is really beyond comprehension, immoral and likely criminal,” said the attorney Bill Marler.

“Why the Sarasota and Florida Departments of Public Health have not stopped production and sales and ordered a full recall is a failure to protect the public.”

Officials with Big Olaf have advised stores to stop selling its products but has not initiated a recall. The company, based in Sarasota, FL, was founded in 1982 and has 15 retail locations around the state, according to the company website. The stores sell ice cream for consumption on site as well as packaged to take home. Some of them are licensed by the company while others merely feature Big Olaf products.

According to Ryan Ballogg of the Bradenton Herald, the Florida Department of Health is leading the epidemiological investigation of the Listeria outbreak. On Wednesday, spokesman Jeremy Redfern told the Bradenton Herald that consumers should continue to avoid Big Olaf products. 

“The Department of Health advised Big Olaf to suspend sales and production until further notice. They informed us that they’d be contacting those that serve their product to recommend that they stop serving.

“It appears that they aren’t necessarily taking our advice,” Redfern said in an email.” 

The company has posted a rebuttal on its Facebook page stating that it has “been cooperating with the Florida Department of Health, FDACS and the FDA as soon as we were informed about the situation,” the post says. “We have been transparent and have answered all their questions and provided them with all the information requested from us, as the health and well-being of the public is our first priority.”

In its report on Saturday, July 2, The U.S. CDC said of 22 patients with information available, 20 reported living in or traveling to Florida in the month they became sick. Illnesses started on dates ranging from January 24, 2021, through June 12, 2022.

The CDC notice states that the sick people ranged in age from less than 1 to 92 years old.

The Florida Department of Health, CDC, public health and regulatory officials in several other states, and the U.S. Food and Drug Administration (FDA) are involved in the outbreak investigation. Of the 17 people interviewed, 14 reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

According to the Big Olaf Creamery website, the company’s ice cream is “made at a local creamery near Sarasota’s Amish village of Pinecraft … hand mixed with the finest ingredients and is then churned in batch freezers by local Amish Craftsmen.”

Big Olaf products are only sold in Florida but only a dozen of the patients live in the state, according to the CDC.

Patients have been reported in Colorado as well as, one in Georgia, one in Illinois, one in Kansas, two in Massachusetts, one in Minnesota, one in New Jersey, two in New York and one in Pennsylvania. Of 10 people who provided the CDC with their travel information, eight reported travel to Florida in the month prior to getting sick.

Attorney Marler told USA Today that while it can be tough to pinpoint the source of listeria cases, because symptoms can take between three and 70 days to appear in patients, it’s relatively easy to link cases to a single source when genetic fingerprints are used. 

“Whole genome sequence gives you beyond a reasonable doubt – this is the kind of technology used in criminal cases, DNA sampling, that kind of stuff,” he said. “It’s been a game changer in the food space because you know that if people have the same genetic fingerprint, you know it came from the same place.”

Listeria monocytogenes is a deadly bacteria that generally hospitalizes more than 95 percent of those with confirmed cultures and kills at least 25 percent, according to the CDC. 

More about Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the implicated ice cream and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the ice cream should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

Editor’s note: Bill Marler is the publisher of Food Safety News.

Officials have not yet been able to find the food source that is causing the infections, according to an update from the Food and Drug Administration. A week ago the patient count stood at 42. As of July 6 there are 59 people who have been confirmed with infections.

The FDA first posted the Salmonella Braenderup outbreak on June 22.  The agency has begun traceback efforts but has not reported what food or foods are being traced.

For a Listeria monocytogenes outbreak first posted April 13, the FDA has identified Big Olaf ice cream from Florida as the source of the bacteria. The patient count stands at 23 with one death reported. The company has not initiated a recall, but has alerted retailers to not sell its branded products.

In other outbreak news, an investigation of a hepatitis A outbreak linked to fresh strawberries continues in the United States and Canada. In the U.S. 18 confirmed patients have been identified with 13 of them having been hospitalized.

An investigation of Salmonella infections linked to Jif peanut butter continues with the patient count standing at 16 with two hospitalizations.

Several other outbreaks of known and unknown origin are under investigation. For information on additional outbreaks, please see the table below. Click here to go to the FDA page with links to details on specific outbreaks.

Additional outbreak information
The table below shows information about outbreak investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion. The table below has been abbreviated to show only active investigations.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

(To sign up for a free subscription to Food Safety News,click here

That question is being disputed during the pre-trial stage of the United States v. Paul Kruse. Pre-trial motions are scheduled for July 22 in the Texas Western District court in Austin.

Kruse, 67, is the retired president of Blue Bell ice cream, the iconic Texas brand that in 2015 was at the center of a deadline listeriosis outbreak. As they approach the Aug.1 trial date for the start of the federal criminal trial that will decide his guilt or innocence, Kruse’s defense attorneys have moved to exclude sanitary issues from jury review.

The defense team, Chris Flood of House and John Cline of Seattle, have moved to strike sanitation issues from the indictment, thereby preventing that information from ever going to the jury.

The four government prosecutors assigned to the case oppose the defense motion. “Because the allegations regarding sanitation issues are material and relevant to the defendant’s scheme to defraud Blue Bell Creameries, L.P. (Blue Bell) customers, the motion should be denied,” government attorneys say.

Tara M. Shinnick, Matthew Lash, Patrick H. Hearn, and Kathryn A. Schmidt are the four attorneys assigned to represent the government. All four are from the U.S. Department of Justice Consumer Protection Branch.

Kruse was indicted in 2020 for one count of conspiracy and six counts of wire fraud. He pleaded not guilty to the charges.

The indictment claims there was a conspiracy to obtain money from Blue Bell customers by “false and fraudulent” pretenses.

The government attorneys say Kruse “knew for years that appropriate practices to ensure sanitary conditions were not being followed and achieved at Blue Bell manufacturing facilities, a practice which resulted in a deadline outbreak of disease.”

They say the origins of the 2015 listeriosis outbreak at two Blue Bell plants occurred “long before. “The evidence at trial will show that as early as 2010, the defendant was aware of roof leaks, condensation, and other unsanitary conditions at Blue Bell plants and yet allowed them to persist, prosecutors tell the court. “Under his leadership, Blue Bell shipped products with levels of coliforms that he knew exceeded the state standard. 

“.Coliform testing is commonly used in the food industry to indicate the sanitary quality of products and the sanitary conditions of manufacturing facilities,” they add. “It is understood in the food industry that high levels of coliforms indicate unsanitary conditions in the facility, which can lead to bacteria and contamination issues, including the presence of L. mono (Listeria monocytogenes).”

In keeping the sanitation issues before the yet-to-be picked jury, the government says that because of high coliform levels at Blue Bell facilities, the company’s Quality Assurance team started testing finished products for Listeria in 2011. 

They say the Quality Assurance Manager will testify at trial that Kruse ordered it be shut down. “After this instruction from the defendant, two samples that had already been sent for testing came back presumptively positive for Listeria.

 According to the government, the defendant again ordered the program to be shut down when told about the presumptive positive tests. “The evidence at trial will show that Blue Bell shipped those presumptive positive products out to customers without regard to their safety.”

The defense argued that a discussion of sanitary issues is “surplusage” to the indictment. The prosecution cites judicial sources to say that such a motion must be “exacting and strict” and is rarely granted.

The prosecutors say a “court should not grant a defendant’s motion to strike surplusage as prejudicial unless it is clear that the information is not relevant and is prejudicial.” 

“If the evidence of the allegation is admissible and relevant to the charge, then despite prejudice, the language will not be stricken,” they add.

Kruse is a resident of Brenham, TX, the headquarters of Blue Bell, and its long association with his family.

He issued, in 2015, the first recall in the company’s century-long history and suspended all production for several weeks. In the four-state outbreak, there were three deaths among 10 illnesses. All 10 patients were hospitalized.

A federal Grand Jury indicted Kruse in 2020 after a five-year investigation.

The Austin-based federal Western District Court for Texas has state that it “finds the United States v. Kruse a complex criminal case.” 

As a corporate entity, Blue Bell pleaded guilty in a related case in 2020 to two counts of distributing adulterated food products in violation of the Federal Food, Drug, and Cosmetic Act.

The company agreed to pay criminal penalties totaling $17.5 million and $2.1 million to resolve False Claims Act allegations regarding ice cream products manufactured under unsanitary conditions and sold to federal facilities, including the military. The total $19.35 million in fines, forfeiture, and civil settlement payments was the second-largest amount ever to resolve a food safety matter.

Kruse is the only individual facing criminal charges because of the 2015 outbreak.

Blue Bell Creameries, founded in 1907 in Brenham, TX, today produces Blue Bell ice cream for national distribution.

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“As a result of this investigation, Big Olaf Creamery in Sarasota, FL, is voluntarily contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product,” according to a notice posted tonight by the federal Centers for Disease Control and Prevention.

As of June 30 there were 23 confirmed patients, one of whom died. Another patient was a pregnant woman who lost her baby because of the infection, the CDC reported earlier this week. Twenty-two of the patients were so sick they had to be hospitalized.

Of the 17 people interviewed as of today, 14 reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

The investigation is ongoing. The company has not initiated a recall.

“Of the 22 people with information, 20 sick people reported living in or traveling to Florida in the month before they got sick, although the significance of this is still under investigation. Illnesses started on dates ranging from Jan. 24, 2021, through June 12, 2022,” the CDC reported.

Whole genome sequencing showed that bacteria from sick people’s samples are closely related genetically. This means that people in this outbreak likely got sick from the same food.

Sick people range in age from less than 1 to 92 years, with a median age of 72, and 52 percent are male. Five people got sick during their pregnancies, and one illness resulted in a fetal loss.

The true number of sick people in an outbreak is likely higher than the number reported, and the outbreak may not be limited to the states with known illnesses, according to the CDC. In addition, recent illnesses may not yet be reported as it usually takes 3 to 4 weeks to determine if a sick person is part of an outbreak.

Seattle food safety attorney Bill Marler represented victims in recent years who were infected with Listeria monocytogenes found in Blue Bell ice cream. He said it is unfortunate to see the scope of the current outbreak in the wake of the Blue Bell outbreak.

The former president of Blue Bell, Paul Krouse, is set to go on trial beginning Aug. 1. The sanitary record of Blue Bell has become a pretrial issue that could spill over into any pre-outbreak record.

The CDC did not specifically report where the Big Olaf ice cream implicated in the current outbreak was manufactured.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the implicated Big Olaf ice cream and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

The fact is that neither the prosecutors nor the defense attorneys have had reason to raise any issues in the Western District Court of Texas since Jan. 6.

That’s when federal Judge Robert Pitman signed the amended scheduling order that remains enforced for jury selection and trial, set for Aug. 1 in Austin.

It’s been a long quiet period in the criminal prosecution of the retired president of the Texas icon known as Blue Bell ice cream. Paul Kruse is charged for actions he allegedly took during a 2015 listeriosis outbreak.

In that four-state outbreak, there were three deaths among the 10 patients, all hospitalized. Blue Bell recalled all ice cream products, and all production was suspended.

In less than 60 days, a Texas jury will decide if Kruse is guilty or innocent of conspiracy and fraud charges brought against him by a federal Grand Jury.

Both the prosecution and defense are under a series of orders in Judge Pitman’s schedule to get the parties ready for trial. While there haven’t been any motion hearings or other pretrial sessions, important dates are ticked off. For example:

• Any pretrial motions related to the potential exclusion of expert testimony that might require a so-called Daubert hearing were due May 26, 2022. (Responses due no later than June 13, 2022.
• The Department of Justices had to file witness and exhibit lists no later than June 2, 2022
• DOJ by no later than June 2, 2022, had to provide the defense with so-called impeachment evidence
• DOJ has until June 2, 2022, to provide the defense with notice of evidence it intends to pursue. — The defense has until June 16, 2022, to object.
• The defense list of witnesses and exhibits is due no later than June 17, 2022.
• All pretrial motions, including motions in limine, are due no later than June 22, 2022.

A motion in limine is made away from the jury to include and exclude evidence.

The parties agree that United States v. Kruse is a “complex criminal case.” Jury instructions will be filed on June 17, 2022, with the defense having until July 1, 2022, to object and DOJ has until July 18 to file any response.

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The recalled products have been sold nationally in Canada, according to a recall notice posted by the Canadian Food Inspection Agency.

There is concern that consumers may have the products in their homes because of the long shelf life of ice cream. Consumers can use the following information to determine whether they have the products on hand.

Recalled products:

Recalled products should be thrown out or returned to the location where they were purchased.

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The ice cream products were distributed in Massachusetts.

The company said testing by the Food and Drug Administration revealed the presence of the Listeria monocytogenes.

The products were packaged in paper 16-ounce pints with the “Batch Ice Cream” name and flavors printed on the front.

The products have a date of manufacture of 1/19/22 and best-by date of 7/19/23, located on the bottom of the cup, according to the recall announcement.

There is concern that consumers may have the products in their homes because of the long shelf life of the ice cream.

Consumers can use the following label information to determine whether they have the ice cream in their home freezers.

The products have the following UPC numbers:

• Vanilla — 837654968505
• Ginger — 83765496856
• Mocha chip — 83765496853

As of the posting of the recall notice the company said no illnesses have been linked to the recalled products.

Consumers who purchased the recalled products are urged to return them to the place of purchase for a refund, the company said.

Those with questions can call the company at 860-649-5358.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

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“The problem was identified and was promptly corrected. No injuries have been reported. The items that may have been impacted and are subject to the recall are listed below the recall actions requested,” according to a recall notice on the Costco website.

Any consumers who have the affected products are urged to dispose of them immediately. Consumers can contact [email protected] with proof of purchase for reimbursement in the form of a print-at-home or physical coupon, according to the recall notice.

“Our team remains in close communications with the FDA (Food and Drug Administration) and has taken proactive measures in remedying this situation. We are working with our trusted retail partners to implement the recall and remove the affected lots from shelf,” according to the Clio notice.

Consumers with questions can also contact the company via email at [email protected].

The recalled products are:

• Clio Snacks Mixed Berry & Peach Less Sugar, 16 count, UCP number 854021008220, expiration dates ranging from 2/14/2021 to 7/11/2021;
• Clio Snacks Vanilla & Strawberry Minis 24 count, UPC number 854021008138, expiration dates from 2/21/2021 to 7/4/2021; and
• Clio Snacks Vanilla & Strawberry 16 count, UPC number 854021008022, expiration dates from 2/14/2021 to 5/9/2021.

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The products were distributed to Indiana, Kentucky, Ohio,and West Virginia through various drug stores, convenience stores and supermarkets. They are packaged in various sizes and containers.

The issue was identified as a result of the company’s routine testing.

As of the posting of this recall, there have been no illnesses associated with the recalled products.

There is concern that consumers could have unused portions of the recalled ice cream products in their homes because of the long shelf life of the products.

The products were distributed and sold in supermarkets on or after March 24 with the following product codes, which can be found at the bottom or side of the container.

Recalled products:

• 21104 Buehler’s Chocolate Pail
• 21104 Buehler’s Neapolitan Pail
• 21104 Buehler’s Vanilla Pail
• 21089 Discount Drug Mart Chocolate Swirl Pail
• 21106 Discount Drug Mart Neapolitan 56oz
• 21095 Discount Drug Mart Strawberry 56
• 21091 Discount Drug Mart Vanilla 56
• 21083 Discount Drug Mart Vanilla Pail
• 21096 North Star Frog Spit
• 21097 North Star Frog Spit
• 21098 North Star Frog Spit
• 21099 North Star Frog Spit
• 21089 Whale of a Pail Chocolate Fudge Pai
• 21090 Whale of a Pail Cookies n Cream
• 21104 Whale of a Pail Neapolitan
• 21103 Ruggle’s Orange Sherbet Quarts
• 21104 Whale of a Pail Vanilla Chocolate
• 21089 Whale of a Pail Vanilla
• 21090 Whale of a Pail Vanilla
• 21090 Super Dip Chocolate Pail
• 21103 Super Dip Chocolate Swirl Pail
• 21083 Super Dip Chocolate Swirl Pail
• 21089 Super Dip Chocolate Swirl Pail
• 21083 Super Dip Cookie n Cream Pail
• 21106 Super Dip Neapolitan 56oz
• 21104 Super Dip Neapolitan Pail
• 21095 Super Dip Strawberry 56
• 21106 Super Dip Superfriends 56oz
• 21091 Super Dip Vanilla 56
• 21083 Super Dip Vanilla Pail
• 21103 Super Dip Vanilla Pail
• 21089 Super Dip Vanilla Pail
• 21090 Super Dip Vanilla Pail
• 21106 Super Dip Vanilla/Orange 56oz
• 21106 Velvet erVanilla Lovers Trio 56oz
• 21091 Velvet Banana Cream Pie 56
• 21088 Velvet Birthday Cake 3 gallon
• 21084 Velvet Black Walnut 3 gallon
• 21099 Velvet Blackberry Cobbler 56
• 21095 Velvet Blueberry Cheesecake 56
• 21095 Velvet Buckeye Brownie 56
• 21091 Velvet Buckeye Brownie 56
• 21095 Velvet Buckeye Classic 56
• 21096 Velvet Buckeye Classic Pint
• 21102 Velvet Buckeye Sandwich 12/10pk 
• 21096 Velvet Butter Pecan & Cashew Pint
• 21105 Velvet Campfire Smores 56oz
• 21100 Velvet Caramel Pecan 56
• 21106 Velvet Chocolate Pint
• 21096 Velvet Chocolate Pint
• 21105 Velvet Cookie Dough Extreme 56oz
• 21105 Velvet Cookie Dough Extreme 3 gallon
• 21084 Velvet Cookie n Cream 3 gallon
• 21092 Velvet Cookies n Cream Pint
• 21103 Velvet Cotton Candy 3 gallon
• 21092 Velvet Dutch Chocolate 56
• 21089 Velvet Dutch Chocolate 3 gallon
• 21102 Velvet Dutch Chocolate 3 gallon
• 21099 Velvet Elephant Ear 56
• 21084 Velvet Elephant Ear 3 gallon
• 21092 Velvet Homemade Vanilla 56
• 21105 Velvet Homemade Vanilla 56oz
• 21100 Velvet Kentucky Praline Pecan 56
• 21085 Velvet Lime Sherbet Quart
• 21103 Velvet Lime Sherbet Quarts
• 21091 Velvet Mint Chocolate Chip 56
• 21102 Velvet Mint Chocolate Chip 3 gallon
• 21091 Velvet Moose Tracks 56
• 21095 Velvet Moose Tracks 56
• 21096 Velvet Moose Tracks Pint
• 21092 Velvet Olde Tyme Vanilla 56
• 21105 Velvet Olde Tyme Vanilla 56oz
• 21102 Velvet Olde Tyme Vanilla 3 gallon
• 21084 Velvet Orange Sherbet 3 gallon
• 21085 Velvet Orange Sherbet Quart
• 21103 Velvet Orange Sherbet Quarts
• 21091 Velvet Original Vanilla 56
• 21084 Velvet Original Vanilla 3 gallon
• 21089 Velvet Original Vanilla 3 gallon
• 21100 Velvet Original Vanilla 3 gallon
• 21102 Velvet Original Vanilla 3 gallon
• 21084 Velvet Pineapple Sherbet 3 gallon
• 21084 Velvet Pineapple Sherbet Quart
• 21085 Velvet Pineapple Sherbet Quart
• 21103 Velvet Pineapple Sherbet Quarts
• 21103 Velvet Rainbow Sherbet 3 gallon
• 21103 Velvet Rainbow Sherbet Quarts
• 21085 Velvet Raspberry Sherbet Quart
• 21084 Velvet Sea Salt Caramel Toffee 3 gallon
• 21099 Velvet Summertime Peach 56
• 21099 Velvet Summertime Peach 3 gallon
• 21084 Velvet Summertime Peach 3 gallon
• 21092 Velvet Triple Chocolate Chunk 56
• 21100 Velvet Vanilla Bean 3 gallon
• 21088 Velvet Vanilla Pint
• 21106 Velvet Vanilla Pint

Anyone who has the recalled product in their possession should dispose of it immediately or return it to the place of purchase for a refund.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled product and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.)

The company reports the recall includes 10,869 containers of Weis Quality Cookies and Cream Ice Cream and 502 bulk containers of Klein’s Vanilla Dairy Ice Cream, according to a notice posted by the Food and Drug Administration.

According to the recall notice, the implicated Weis Quality Cookies and Cream Ice Cream in 48-ounce containers has been removed from sale. It was sold in 197 stores in Pennsylvania, Maryland, Virginia, New Jersey, New York, Delaware and West Virginia.

There is concern that consumers and retailers may have unused portions of the recalled ice cream on hand because of its long shelf life.

Consumers can use the following label information to determine whether they have the recalled ice cream:

• Weis Quality Cookies and Cream ice cream is packaged in round 48-ounce containers with a UPC number of 041497-01253 and a sell-by date of 10/28/21. The ice cream was produced on Oct. 28, 2020, and released for sale on Oct. 29, 2020. The sell-by date is located on the bottom of the container.
• The Klein’s Vanilla bulk ice cream is packaged in 3-gallon containers with a code stamp of 0302 and are not for retail sale. This product was sold to one retail establishment in New York and has been removed from sale.

“The recall was issued after a customer discovered an intact piece of metal equipment in the Weis Quality Cookies and Cream Ice Cream — 48 oz. There is concern of an additional piece of equipment present in the ice cream that could present a choking hazard,” according to the recall notice.

The FDA recommends that consumers who have purchased this product return it for a full refund.

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Inspectors at the Czech Agriculture and Food Inspection Authority (SZPI) looked at safety and quality of scooped and soft whipped ice creams and ice used for beverages, including equipment for their preparation. These checks were mainly in confectioneries and on public catering premises.

Results showed a number of operators failed to follow prescribed production procedures and a significant amount of samples did not comply with legislative requirements, especially on ​​limits for the presence of bacteria. In the period up to July 31, 2020, 30 percent of ice creams and almost 43 percent of ice samples for beverages failed.

Ice cream findings
In 2020, SZPI inspectors have evaluated 64 samples of soft whipped and scooped ice cream and 19 did not meet hygiene limits. Laboratory analyses confirmed numbers of Enterobacteriaceae bacteria above the limit. The number of samples evaluated is slightly lower compared to previous years due to the later start of the season.

During inspections in 2019, 37 percent of samples failed to comply with legislation compared to 30 percent in 2018, and 26 percent in 2017.

The main cause of unsatisfactory results is insufficient sanitation of ice cream production equipment as well as contaminated raw materials, the assessment of which often consists of only visual inspection by food businesses. Insufficient staff training can also play a role, said SZPI.

One of the common causes of the problem with soft whipped ice cream is the practice of operators putting remaining ice cream into the machine the next day and not disposing of it at the end of the previous day. This procedure may cause transmission of bacterial contamination from the machine into the ice cream mixture and vice-versa.

Checks on ice
Inspectors evaluated 21 ice samples used for beverages and nine did not meet health or hygiene limits. The monitored parameters included occurrence of E. coli, Clostridium perfringens, enterococci, coliform bacteria and bacterial colonies.

During inspections in 2019, 40 percent of samples failed legal limits while 47 percent failed in 2018, and 45 percent in 2017. The main cause of these findings is underestimation of hygiene practices during the production of ice.

Results from 2020 and previous inspections show that many operators still significantly underestimate the risks related to neglecting hygiene procedures during production, storage and sale of these products.

However, the share of non-compliant samples cannot be generalized for the entire market, because SZPI selects them according to a risk analysis and problematic establishments are checked more frequently.

In sites where SZPI inspectors took unsatisfactory samples, a ban on using equipment was imposed on the spot and the operator was ordered to perform sanitation and subsequent microbiological analysis by an accredited laboratory. Inspectors will only allow equipment to be used again after a satisfactory result from this analysis.

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Findings highlight the public health risk associated with these items and provide further justification for continued surveillance and controls during production and throughout the food chain, according to the study published in the journal Epidemiology and Infection.

It reviewed microbiology results from 2,500 raw drinking milk and dairy products made with unpasteurized milk examined in England between 2013 and 2019. Samples were collected from the point of sale and place of manufacture as part of incidents of contamination, investigation of infections, or routine monitoring and were tested using standard methods for pathogens and hygiene indicators.

Raw cow’s milk for drinking can only be sold at farms and farm shops at production, including local deliveries and farmer’s markets. These restrictions do not apply to milk from other species or other dairy products made from unpasteurized milk.

Results and outbreaks
The dataset included: 719 raw cow’s milk from 2017 to 2019, 584 raw milk from non-bovine animals; 100 cream, two ice cream, 37 butter, 24 kefir, and 1,063 cheeses from 2013 to 2019.

Amongst all 2,529 samples tested, 69 percent were classed as satisfactory microbiological quality, 10 percent were borderline, 16 percent were unsatisfactory and 5 percent were unsatisfactory and posed a potential risk to public health due to pathogens. Results from routine monitoring were satisfactory for 62 percent of milk, 82 percent of cream, all ice cream, 51 percent of butter, 63 percent of kefir, and 79 percent of cheeses.

For all samples, 56 bovine milks and 79 cow or goats milk cheeses were associated with six incidents of infection. These included three raw cow’s milk outbreaks in 2017 with seven cases of STEC O157: H7, four Campylobacter infections, and one patient with Salmonella Dublin.

One person got Salmonella Mbandaka from cheese made at the same farm previously linked to a STEC outbreak, one listeriosis patient bought cheese from a farm shop in 2016, and coagulase-positive staphylococci (CPS) contamination involved hard goat’s milk cheese which did not enter the food chain in 2013.

Results of microbiological testing of cow’s drinking milk and cheese samples collected during incidents and foodborne outbreaks showed a higher proportion as potentially injurious to health: 44 percent compared to 20 percent for those taken for routine monitoring.

Routine monitoring findings
In raw drinking milk collected for routine monitoring, cow’s milk was generally of poorer microbiological quality than goat’s or sheep’s milk, for the presence of indicators and pathogens. Two unsatisfactory goat’s milk samples had high levels of CPS and unsatisfactory levels of aerobic colony counts (ACC) and coliforms: both samples came from the same farm in the same year.

For raw cow’s drinking milk tested in routine monitoring, results from 24 samples were unsatisfactory because of the presence and levels of pathogens. Campylobacter spp. were isolated from 18 cow’s milk samples, 13 of which came from three producers. In five other samples, Salmonella Mbandaka was isolated from one, unsatisfactory levels of coliforms detected in three, and unsatisfactory ACCs were found in the final sample. In one cow’s milk sample there was an unsatisfactory level of Listeria monocytogenes.

Salmonella was detected in three samples, once it was Salmonella Mbandaka and in the other two, Salmonella Dublin was isolated on different occasions from the same dairy. In the remaining three cow’s milk samples potentially risky to health, STEC was isolated. Two isolates came from different samples from the same farm and were both STEC O113: H4, the final isolate was STEC O15: H16.

Amongst the 984 kinds of cheese tested as part of routine monitoring, 80 percent were of satisfactory microbiological quality, 5 percent were borderline, 10 percent were unsatisfactory and 5 percent potentially injurious to health.

Goat milk cheeses were of poorer microbiological quality than those from the milk of other species. The 47 cheese were categorized as posing a risk to health because of high levels of Listeria monocytogenes or CPS, or isolation of Salmonella, E. coli O157, or STEC. Two possible cases with indistinguishable Salmonella Newport isolated from a hard cow’s milk cheese were found. Two samples of kefir were unsatisfactory due to CPS: one was prepared from cow’s milk and the other from goat’s milk.

Results indicated statutory hygiene indicator tests for raw drinking milk do not correlate well with the presence of pathogens but analysis of data from cheese showed an association between increasing levels of indicator E. coli with elevated levels of CPS and detection of stx genes. Isolation of STEC was significantly associated with lower levels of indicator E. coli.

The review found a similar level of adverse results to that reported previously for samples tested between 2014 and 2016 showing there is no evidence to support improvement in microbiological quality despite efforts by the Food Standards Agency. The FSA recommends businesses test raw bovine milk for indicator bacteria (E. coli, Listeria spp., ACCs, coliforms) and pathogenic bacteria (Salmonella, STEC, Campylobacter, CPS, and Listeria monocytogenes).

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