Nonprofit activist group, STOP Foodborne Illness, has announced that the organization has finalized recommendations to the Food and Drug Administration (FDA) to modernize the nation’s food recall system.

The recommendations, titled “Collaborative Plan to Achieve Customer-Focused Recall Modernization,” outline the steps needed for the U.S. to improve its recall process. STOP Foodborne Illness sees the current recall process as antiquated and disjointed.

The nation’s food recall system hasn’t been enhanced in five years. But last year, the FDA in its “New Era for Smarter Food Safety” blueprint made updating procedures for reaching consumers about potentially unsafe food products a priority.

“For nearly a year, we’ve engaged with collaborators representing the nation’s leading food manufacturers, retailers and scholars to develop an innovative, consumer-focused process that can be implemented to update and upgrade our nation’s ability to inform the public about food recalls,” said Ben Chapman, co-chair of the STOP Foodborne Illness board and professor and Food Safety Extension Specialist at North Carolina State University.

“Without question, reaching people about potential food safety issues quickly and effectively is critical to public health. We believe that the recommendations our working group produced will positively impact public health and save lives.”

The proposals will be delivered to Janet Woodcock, FDA Acting Commissioner and to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

“At STOP, we connect with consumers, the food industry and regulators to promote food safety and education,” said Mitzi Baum, CEO of STOP Foodborne Illness.

“Because we bridge all of these constituencies, we bring a collaborative mindset to our work and seek solutions that can be broadly adopted. To that end, we have initiated a conversation with the United States Department of Agriculture to enlist that department’s support in our ongoing efforts to enhance the safety of the U.S. food supply.”

Plan highlights

STOP Foodborne Illness provided a prioritized list of topics for action with proposed plans to support the New Era Blueprint. They recommend that the FDA:

  1. Conduct an evaluation of recall effectiveness (including consumer actions) across federal agencies. Standardize recall coordination and execution across federal agencies.
  2. Support technology application in recall execution, management, and communications with a specific focus on small and mid-size enterprises (SMEs).
  3. Develop and implement a risk communication strategy for regulatory and industry partners. Drive programs resulting in timely, accessible and effective information to protect consumers.

The full plan can be viewed here, “Collaborative Plan to Achieve Customer-Focused Recall Modernization.”

As of April 22, 2020, this outbreak was over according to the CDC.

51 people infected with the outbreak strain of E. coli O103 were reported from 10 states.3 people were hospitalized. No deaths were reported.

Epidemiologic, traceback, and laboratory evidence indicated that clover sprouts were the source of this outbreak.On March 16, 2020, Chicago Indoor Garden recalled all products containing red clover sprouts.

Jimmy John’s LLC reported that all of its restaurants stopped serving clover sprouts on February 24, 2020.

However, litigation – especially in Utah were the vast majority of cases occurred continues.  The Court granted our motion to amend the complaint to add a claim for punitive damages.

For those that want to read the blow by blow, read the below:

Knorr – Motion for Leave to file Second Amended Complaint add punitive damages 4-19-21

Knorr, Travis – Chapman – Jimmy Johns – Declaration-signed copy

Chapman-Jimmy-Johns-expert-report-4-5-21-final

Jimmy Johns – Sprout-Associated-Outbreaks-4-12-21

Ruling – Knorr

As of July 14, 2021, eight people infected with the outbreak strain of Salmonella Typhimurium have been reported from two states. Illnesses started on dates ranging from June 10, 2021, to June 15, 2021.

BrightFarms today initiated a voluntary recall of packaged salad greens produced in its Rochelle, Illinois (Ogle County) greenhouse farm sold in Illinois, Wisconsin, Iowa and Indiana because it has the potential to be contaminated with Salmonella.

The affected BrightFarms-branded products were sold by the following retailers:

  • Illinois: Mariano’s Fresh Markets, Walmart (select stores), Strack Van Till, Sullivan’s Foods, Caputo’s, Jewel-Osco
  • Wisconsin: Pick ‘n Save, Metro Market, Copps, Tadych’s, Walmart (select stores)
  • Iowa: Walmart (select stores)
  • Indiana: Strack Van Till

Additional retailers may be affected.

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis

The recall includes the below salad products packaged in clear, plastic clamshells with “best by” dates through 7/29/2021:

  • BrightFarms NutrigreensTM (3 oz. package)
  • BrightFarms Butter Crisp TM (4 oz. Package)
  • BrightFarms Harvest Crunch® (4 oz. package)
  • BrightFarms Mighty Romaine TM (4 oz. and 8 oz. package)
  • BrightFarms 50/50 Spring & Spinach (4 oz. package)
  • BrightFarms Spring Crunch (4 oz. package)
  • BrightFarms Spring Mix (4 oz. and 8 oz. package)
  • BrightFarms Sunny Crunch ® (4 oz. and 8 oz. package)
PRODUCT NAME PACKAGES UPC LABEL
BrightFarms NutrigreensTM 3 oz. package 5706200458 see image below
BrightFarms Butter Crisp TM 4 oz. package 5706200484 see image below
BrightFarms Harvest Crunch ® 4 oz. package 5706200486 see image below
BrightFarms Mighty Romaine TM 4 oz. package
8 oz. package
5706200452
5706200491
see image below
BrightFarms 50/50 Spring & Spinach 4 oz. package 5706200440 see image below
BrightFarms Spring Crunch 4 oz. package 5706200470 see image below
BrightFarms Lakeside CrunchTM 4 oz. package 5706200470 see image below
BrightFarms Spring Mix 4 oz. package
8 oz. package
4 oz: 5706200441
8 oz: 5706200451
see image below
BrightFarms Sunny Crunch ® 4 oz. package
8 oz. package
4 oz: 5706200460
8 oz: 5706200485
see image below

In April 2021, CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) began collecting different types of data to investigate a multistate outbreak of Salmonella infections.

Epidemiologic, laboratory, and traceback data showed that Jule’s cashew brie was contaminated with Salmonella and made people sick.

As of July 7, 2021, this outbreak is over.

This outbreak included people infected with one of four Salmonella serotypes: Chester, Duisburg, Typhimurium, and Urbana.

A total of 20 sick people were reported from four states – California, Tennessee, Florida and Maryland. Illnesses started on dates ranging from December 11, 2020, to May 9, 2021.

Sick people ranged in age from 1 to 72 years, with a median age of 26 years, and 65% were female. Five people were hospitalized, and no deaths were reported.

State and local public health officials interviewed people about the foods they ate in the week before they got sick, and 15 (79%) reported eating Jule’s cashew brie – the only common product identified.

Officials from California and Tennessee collected samples of Jule’s cashew brie for testing. WGS results showed that samples of Jule’s truffle cashew brie collected in both states were contaminated with Salmonella. California officials found the outbreak strains of Salmonella Chester and Urbana in the brie, and Tennessee officials found the outbreak strain of Salmonella Urbana.

FDA and California Department of Public Health inspectors conducted an inspection at Jule’s Foods. FDA collected food and environmental samples from the facility and found the outbreak strain of Salmonella Urbana in samples of raw cashews. These raw cashews were from the same lot of cashews used to make the recalled brie. Other strains of Salmonella were found in the food and environmental samples, but these strains were not linked to any illnesses.

Tyson Foods Inc., a Dexter, Mo. establishment, is recalling approximately 8,492,832 pounds of ready-to-eat (RTE) chicken products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, fully cooked chicken products were produced between December 26, 2020 and April 13, 2021. The products that are subject to recall are listed here. View the labels here.

The products subject to recall bear establishment number “EST. P-7089” on the product bag or inside the USDA mark of inspection. These items were shipped nationwide to retailers and institutions, including hospitals, nursing facilities, restaurants, schools and Department of Defense locations.

On June 9, 2021, FSIS was notified of two persons ill with listeriosis. Working in conjunction with the Centers for Disease Control and Prevention (CDC) and state public health partners, FSIS determined there is evidence linking the Listeria monocytogenesillnesses to precooked chicken produced at Tyson Foods Inc. The epidemiologic investigation identified three listeriosis illnesses, including one death, between April 6, 2021 and June 5, 2021. During routine sample collection, FSIS collected two precooked chicken samples from two establishments that are closely related genetically to Listeria monocytogenes from ill people. One of the samples was collected at Tyson Foods Inc. FSIS is continuing to work with federal and state public health partners to determine if there are additional illnesses linked to these products.

It was only a matter of time – as commercial marijuana becomes a thing that we would see recalls due to bacterial contamination.  We should expect to see the same in other, especially edible, marijuana products.

Multiple Arizona marijuana establishments and dispensaries are initiating a voluntary recall of specific marijuana products due to possible contamination with Salmonella or Aspergillus. See below for a table with the product, lot numbers, product names it was sold under, and the possible contaminant.

The Arizona Department of Health Services (ADHS) is advising purchasers to dispose of the products described in the table below, which were found in laboratory tests to be positive for Salmonella or Aspergillus.

To date, no illnesses have been reported. This announcement is being made out of an abundance of caution. Patients who have purchased potentially contaminated products should not ingest, inhale, or otherwise consume them and should dispose of them. If you have already consumed any of the products and have any of the symptoms described below, please contact your healthcare provider or seek emergency care in the event of an emergency.

The ADHS laboratory auditors determined during routine inspection of an independent third-party laboratory that marijuana samples that tested positive for Salmonella were reported to dispensaries and marijuana establishments as free of contaminants. In addition, marijuana samples that tested positive for Aspergillus were reported to dispensaries and marijuana establishments as free of contaminants.

Once ADHS discovered the positive test results, the establishments involved were notified and took immediate action to work with all distribution and retail partners to remove any potentially impacted products.

Consumers with any questions may contact the establishment or dispensary they purchased any of the products on the list below.

Salmonella: Symptoms from ingesting salmonella usually start within 6 hours–6 days after infection and last 4–7 days. Ingestion can happen inadvertently after handling Salmonella-contaminated products. Symptoms include:

  • Diarrhea (that can be bloody)
  • Fever
  • Stomach cramps
  • Some people may also have nausea, vomiting, or a headache.

Aspergillus: Aspergillus can cause allergic reactions or infection, usually in people already sick with something else. Symptoms range from asthma or cold like symptoms to fever and chest pain among many others.

PRODUCTS

Brand Name Product Name Batch Number Product Type Implicated Contaminant
Harvest Platinum 14g Pre Pack Indica Flower (Glazed Apricot Gelato) CVGH210406HB Plant, Trim Salmonella
Harvest Platinum 14g Pre Pack Sativa Flower (Tiger Haze) CVGH210406HM (L) Plant, Trim Aspergillus
Modern Flower 3.5g Pre Pack Indica Flower (Orange Acai) CVGH2104210HI Plant, Flower – Cured, Greenhouse Aspergillus sp.
Sol Flower Dispensaries and Establishments Tahiti Lime 0121TILM.33.WT Plant, Flower – Cured Aspergillus sp.
EHF (Elephant Head Farms) HAT Trick #17 Flower 030821F1H12 Plant, Flower – Cured Salmonella
Mohave Cannabis Preroll LAB #454 PR Plant, Preroll, Indoor Salmonella
Tru Infusion Flower Cherry WIFI 0326R12CUC Plant, Flower – Cured indoor Aspergillus sp.
The Pharm Chemistry #1 (HD 3/24/21) Chemistry #1 1 B15B.R1-10 Plant, Flower – Cured, Greenhouse Aspergillus sp.

 

On May 12, 2021, The Washington State Department of Health (DOH) announced a multi-county outbreak of E. coli O157:H7 that began as a Public Health-Seattle & King County investigation involving several children with E. coli. The outbreak is linked to PCC Community Market brand yogurt produced by Pure Eire Dairy.

Update June 17, 2021:

One new child case has been identified who was infected with the outbreak strain of E. coli O157:H7 and was hospitalized for their illness. This brings the total number of outbreak-associated cases to 16.

The two Arizona cases infected by the outbreak strain of E. coli O157 did not consume PCC or Pure Eire brand yogurt.

  • The first Arizona case is considered a secondary infection. This person was infected after having close contact with a Washington state resident who regularly ate Pure Eire yogurt and developed diarrhea (but was not tested) shortly before traveling to Arizona.
  • The newest Arizona case added on 6/17/2021 is also considered a secondary infection.

 Public health message

  • If you have PCC Community Market brand yogurt or Pure Eire yogurt at home, do not eat it and throw it away.
  • E. coli infections can cause serious complications. Symptoms include diarrhea, stomach cramps and blood in the stool.
  • If you notice symptoms, especially bloody diarrhea, contact your health care provider right away.

Case information

DOH is reporting confirmed cases infected with bacteria that have been genetically linked. Local health jurisdictions may report higher numbers for their counties that include cases still under investigation and may provide additional detail on their cases.

Case information will be updated twice a week, as new information is available.

Summary

Statewide total

Cases

Confirmed cases – updated 6/17/21

16

Hospitalized – updated 6/17/21

10

Developed hemolytic uremic syndrome (HUS)

4

Died

0

Cases by county of residence

County

Cases

Benton

1

Clark

1

King

9

Snohomish

2

Walla Walla

1

Yavapai (AZ)

1

Maricopa (AZ) – updated 6/17/21 1

Cases by age

Age range

Cases

0-9 years old – updated 6/17/21

10

10-19 years old

2

20-29 years old

1

30-39 years old

1

40-49 years old

1

50-59 years old

0

60-69 years old

0

70-79 years old

1

80+ years old

0

Public health action

DOH works closely with local health jurisdictions to collect data from interviews of sick individuals to help identify common exposures between, the Washington State Department of Agriculture (WSDA) and other partner agencies on this type of outbreak investigation.

DOH’s role includes:

  • Coordinating with local health and Washington State Public Health Laboratories to identify cases related to the outbreak using genetic testing of the bacteria
  • Collecting data from in-depth interviews conducted by local health jurisdictions with patients about the food they’ve eaten
  • Identifying foods in common between cases and working with partner agencies to trace back foods that may have caused the illness
  • Working with partners to notify food manufacturers and retailers whose products may be linked to the outbreak
  • Supporting partners working to test product samples for presence of bacteria

The investigation process can be long and complex. Only those who are severely ill tend to visit a healthcare provider and get tested, and each step of the process takes time.

Sometimes people don’t get sick until several days after they eat food containing E. colibacteria. It can take a lot of time and effort to test samples from people who are ill, interview them for a detailed history of foods they’ve eaten and look for commonalities between cases.

Linked product information

On May 15, DOH announced a link to PCC Community Market brand yogurt produced by Pure Eire Dairy. Pure Eire Dairy issued a voluntary recall of affected products and PCC removed the products from shelves. Anyone who has PCC Community Market or Pure Eire brand yogurt at home should not eat it and should throw it away.

The investigation is ongoing, and we may identify additional links to products as we continue to gather information from new cases. DOH will provide updates as the investigation progresses.

Over 1,000 sickened with over 200 dead from Listeria tainted polony.  I have the honor to be working with counsel in South Africa – See Listeria Class Action.

Following the declaration of the Listeria outbreak in December 2017, a multi-sectoral outbreak response was initiated. Findings were shared by the Minister of Health, Dr. Aaron Motsoaledi at a public media briefing on 4 March 2018 (statement available at www.nicd.ac.za), and are summarized below. In addition, the National Department of Health requested a full recall of implicated processed meat products.  According to Dr. Aaron Motsoaledi:

In our constant search for the source of the outbreak and the treatment of people who are affected, a team from the NICD has interviewed 109 ill people to obtain details about foods they had eaten in the month before falling ill. Ninety-three (85%) people reported eating ready-to-eat (RTE) processed meat products, of which polony was the most common followed by viennas/sausages and then other ‘cold meats’.

On Friday 12th January, nine children under the age of 5 years presented to Chris Hani Baragwanath Hospital with febrile gastro-enteritis. The paediatrician suspected foodborne disease, including listeriosis, as a possible cause. The environmental health practitioners (EHPs) were informed and on the same day visited the crèche, and obtained samples from two unrelated polony brands (manufactured by Enterprise and Rainbow Chicken Limited (RCL) respectively) and submitted these to the laboratory for testing.

Listeria monocytogenes was isolated from stool collected from one of the ill children, and from both of the polony specimens collected from the crèche. These isolates were sent to the NICD Centre for Enteric Diseases, and underwent whole genome sequencing and genomic analysis. The ST6 sequence type was confirmed on all three isolates on Saturday 27th January. Remember that in the last press conference I informed you that from clinical isolates obtained from patients (patient blood), 9 sequence types of Listeria monocytogenes were isolated and 91% were of sequence type 6 (ST6). We had then concluded that time that this outbreak is driven by ST6.

Following the lead from the tests performed on these children from Soweto and the food they had ingested, the EHPs (Environmental Health Practitioners), together with the NICD and DAFF representatives, accompanied by 3 technical advisors from the World Health Organisation in Geneva, visited a food- production site in Polokwane and conducted an extensive food product and environmental sampling.

Listeria monocytogenes was isolated from over 30% of the environmental samples collected from this site, which happens to be the Enterprise factory in Polokwane.

To conclude the investigation, whole genome sequencing analysis was performed from this Enterprise factory and the results became available midnight or last night. The outbreak strain, ST6, was confirmed in at least 16 environmental samples collected from this Enterprise facility. 

THE CONCLUSION FROM THIS IS THAT THE SOURCE OF THE PRESENT OUTBREAK CAN BE CONFIRMED TO BE THE ENTERPRISE FOOD-PRODUCTION FACILITY IN POLOKWANE

According to the Centre for Enteric Diseases (CED) and Division of Public Health Surveillance and Response, Outbreak Response Unit (ORU), National Institute for Communicable Diseases (NICD)/ National Health Laboratory Service (NHLS) the current number of ill and deceased are as follows:

As of 26 July 2018, 1060 laboratory-confirmed listeriosis cases have been reported to NICD from all provinces since 01 January 2017.

To date, 749 cases were reported in 2017, and 311 cases in 2018. Females account for 56% (549/979) cases where gender is reported. Neonates ≤28 days of age are the most affected age group, followed by adults aged 15 – 49 years of age. Most cases have been reported from Gauteng Province (58%, 614/1060) followed by Western Cape (13%, 136/1060) and KwaZulu-Natal (8%, 83/1060) provinces. Final outcome data is available for 76% (806/1060) of cases, of which 27% (216/806) died.

The U.S. Food and Drug Administration announced that today Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.

U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction on June 1between the U.S. and AffinityLifestyles.com Inc. (majority shareholder of Real Water Inc.), Real Water Inc., Brent A. Jones, president of Real Water Inc., and Blain K. Jones, vice president of Real Water Inc.

“We are committed to preventing harmful products from entering the nation’s food supply, and we will take enforcement action when a company fails to follow the law,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “The FDA, together with our federal counterparts at the U.S. Department of Justice (DOJ), aggressively pursued this injunction and we will continue to take swift action to protect consumers.”

According to the complaint filed by DOJ on behalf of the FDA, defendants violate the FD&C Act by operating facilities that fail to meet preventive controls requirements to control food hazards. The complaint also alleges that defendants violate the FD&C Act by failing to follow current good manufacturing practice (CGMP) requirements for bottled water. The complaint further alleges that defendants’ products are adulterated within the meaning of the FD&C Act because they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. Additionally, the complaint alleges the defendants’ products are misbranded because their labels fail to declare the common or usual name of each ingredient.

The consumption of “Real Water” brand alkaline water was the only known common link between five cases of acute liver failure in children that occurred in November and December 2020 that was reported to the FDA in March. Since then, 11 additional cases of acute non-viral hepatitis in adults, including one death of a woman with underlying medical conditions, have been identified as possibly linked to the consumption of Real Water brand alkaline water. The FDA issued an outbreak advisory on March 16 and continues to investigate, along with the U.S. Centers for Disease Control and Prevention and the Southern Nevada Health District. On March 24, Real Water Inc. of Mesa, Arizona, and Henderson, Nevada, issued a recall of all sizes of its Real Water brand drinking water and concentrate.

The consent decree requires defendants to cease operations until they complete corrective actions, including, hiring a qualified independent expert to inspect their facilities to ensure they comply with the FD&C Act and its implementing regulations. Under the consent decree, defendants may not resume operations until they establish and implement procedures that are adequate to ensure continuing compliance with CGMP and preventive controls requirements and receive authorization from the FDA.

Consumers who think they may have been sickened by defendants’ products, including Real Water Drinking Water, Real Alkalized Water and Real Alkalized Water Concentrate, should seek the assistance of a health care professional and contact the FDA to report problems with this or any FDA-regulated product.

According to the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO), with an estimated 600 million cases of foodborne illnesses annually, unsafe food is a threat to human health and economies, disproportionally affecting vulnerable and marginalized people, especially women and children, populations affected by conflict, and migrants. An estimated 420 000 people around the world die every year after eating contaminated food and children under 5 years of age carry 40% of the foodborne disease burden, with 125 000 deaths every year.

World Food Safety Day on 7 June aims to draw attention and inspire action to help prevent, detect and manage foodborne risks, contributing to food security, human health, economic prosperity, agriculture, market access, tourism and sustainable development. The World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) jointly facilitate the observance of World Food Safety Day, in collaboration with Member States and other relevant organizations. This international day is an opportunity to strengthen efforts to ensure that the food we eat is safe, mainstream food safety in the public agenda and reduce the burden of foodborne diseases globally.

I think about it more on a personal level.  It has been over 28 years since the 1993 Jack in the Box E. coli outbreak sickened several hundred – many with kidney failure – some died – and, changed the trajectory of my legal work.  It was about this time in 1993 that Bri Kiner – who became the face of the litigation – was still months from discharge from the hospital – see Video 

I still recall visiting her and her family in the hospital – I still remember the smell of the room and the look of a shriveled 9-year-old with a gapping wound where once were her large intestines.  It was an honor to try and do justice for her – see the book Poisoned – soon to be a documentary.

I could not even begin to to list all the people around the world that have been impacted by the failures of the food safety system that I have met or represented.  But, there are many that I cannot forget:

Linda Rivera – hospitalized for two years after eating Nestle Toll House Cookie Dough and developing one of the most complex E. coli infections for anyone that survived the acute phase of the infection – see also the Washington Post.

Stephanie Smith – a dancer who lost her ability to even walk because of a E. coli tainted Cargill hamburger – see Pulitzer Prize winning article in the New York Times.

Clifford Tousignant – a Korean War Purple Heart winner who died from Salmonella tainted peanut butter.

Dr. Michael Hauser – who was one of at least 33 people who died from Listeria tainted cantaloupe.

Lucas Parker – a 4-year-old who cannot walk, talk or feed himself due to the severity of his E. coli infection.

You get my point, it has impacted me deeply, but tragically impacted these people and their families.  I could spend hours talking about the Listeria tragedy in South Africa – 1,000 sickened with 200 dead and three years later no justice.

These people all need our concerted efforts.

To all food safety I professionals – we have still much to do.

I will leave you with this video – this, I can never shake.