Not so wholesome: Illinois food company agrees to stop production of contaminated sprouts

On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration.

Wholesome_Soy_Products_logoThe consent decree prohibits Wholesome Soy Products from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat mung bean and soybean sprouts. The company sold its products to wholesale distributors and retail stores in Illinois.

“It is FDA’s responsibility to ensure that appropriate action is taken when we conduct inspections and find results that could put consumers at risk,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “Agreeing to the consent decree is a first step in the right direction for this company.”

This action follows a multi-agency collaboration among the FDA, U.S. Department of Justice, the Centers for Disease Control and Prevention and the Illinois Department of Health.

In August 2014, during a routine inspection of the company, the FDA collected environmental and product samples that tested positive for Listeria monocytogenes (L. mono), a foodborne pathogen that can cause serious illness or even death in vulnerable groups including elderly adults and those with impaired immune systems (such as HIV/AIDS, cancer, diabetes, kidney disease and transplant patients). In pregnant women, L. mono can cause miscarriage, stillbirth and serious illness or death in newborn babies.

On Aug. 28, 2014, Wholesome Soy Products agreed to voluntarily recall and temporarily stop production of their sprout products. The company reported that they cleaned and sanitized their facility. They also hired an independent consultant to collect and test several samples that reportedly came back negative for L. mono. They resumed operations on Sept. 15, 2014, after making these corrections.

Later that month, the company was notified of an outbreak of human infections with a strain of L. monolinked to strains found in the samples previously collected by the FDA during its inspection of the company. According to the CDC, there were four cases in Illinois and one in Michigan. Of those five patients, all were hospitalized and two died.

The FDA began a follow-up inspection of Wholesome Soy Products in October 2014 to verify the effectiveness of the company’s corrective actions. Nine samples taken by FDA inspectors tested positive for L. mono. Due to these findings, the FDA concluded that sprouts could not be safely manufactured by the company in that environment.

In November 2014, the company agreed to voluntarily shut down operations, and the Illinois Department of Public Health oversaw the company’s voluntary destruction of their remaining inventory. The CDC closed its investigation in January 2015 and no further cases of illness in connection to the company have been reported.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Seen and heard: Listeria in Blue Bell ice cream

As the coverage of the 10 case/3 death listeriosis outbreak focuses on the expansion of the recall many are looking at the fallout and environmental and product testing in ice cream facilities

Rachel Abrams and Hiroko Tabuchi of the New York Times report on how customers might react:

Analysts voiced concerns that Blue Bell had acted too late, as the recalls eroded customer confidence. Restoring trust as the summer sales season approaches will be difficult, they say.bluebell3

“When there’s a recall and somebody does something quickly and when they handle it properly, we forgive it,” said Phil Lempert, food industry analyst for “When it’s the entire product line or the entire company,” he said, “people are very concerned.”

“Food and safety recalls are something that retailers take very seriously,” said Dya Campos, a spokeswoman for HEB Grocery. She said the grocer was referring all queries from shoppers to Blue Bell and that it would independently assess whether to carry the brand again once its products were deemed safe.

Food safety lawyer Bill Marler was also quoted about the perception of expanding recalls:

“Limiting the recall might seem like a good idea. But then if you keep expanding your recall, it’s a death by a thousand cuts. You look like you’re dragging your feet.”

Karin Robinson – Jacobs and Sherry Jacobson of the Dallas Morning News dive right into Blue Bell’s response.

The company acknowledged that when it issued its first recall notice, portraying the problem as limited, isolated and small, it did so before thoroughly testing for Listeria throughout its operation.

One food safety expert did not fault the company for its initial brevity, but said subsequent events show that the company expressed confidence too soon.

“Maybe the cleaning and sanitation program that Blue Bell was using wasn’t adequate,” said Benjamin Chapman, a food safety expert with North Carolina State University. “As more samples came back … it highlights that this problem was larger than they originally thought.”

Blue Bell spokeswoman Jenny Van Dorf said that before the initial March 13 recall “we were regularly testing our products at that time for bacteria. There was nothing that indicated that there was any issue,” she said.

She added that the production line identified in the initial recall was in an isolated area of the main Brenham plant, which added to the company’s sense that the problem also was isolated. So far, two lines in Brenham and two in Broken Arrow, Okla., have turned up traces of Listeria.

“We’ve always followed industry standards with testing our product,” she said. “But now going forward, we will specifically test for Listeria.”

Van Dorf said Blue Bell has hired an outside lab and will place any newly produced product in cold storage while waiting for results from tests specifically designed to detect Listeria. The wait could be several days.

The new procedure, called “test and hold” marks a more costly departure from the company’s past testing protocols and lengthens the time before product returns to market.

Chapman noted that there is no federal mandate for how food manufacturers are to test. He said “industry standards” are more like common practices.

But he cautioned against the urge to mandate specific testing methods because each plant is so different.

“I think you get into a very dangerous situation when you start to say there should be a minimum amount of environmental [testing] that goes on because each business has their own particulars. What we need are really good operators who understand where pathogens come from and they know what to do to … reduce the risk.”

Raleigh NBC affiliate WNCN asked me about the outbreak, you can see the interview below.
WNCN: News, Weather, Raleigh, Durham, Fayetteville

130 sickened by soft cheese in 2002: It was the birds

In 2005, Chapman and I went on a road trip featuring a lot of food and funny hats (I also met my wife, got a job at Kansas State and we birthed; 10 years, over 10,000 posts and 42,000 direct subscribers).

DSC00012.JPGFirst stop was Prince George, British Columbia (that’s in Canada) where Chapman was afraid he would get eaten by bears and they had foam parties.

Our host was Lynn Wilcott (on the left, wearing a funny hat).

DSC00009.JPGIn 2002, Lynn and Lorraine McIntyre investigated two outbreaks of Listeria related to soft cheese.

They weren’t allowed to publish for a while because the cases were in litigation, and then well, 10 years went by.



 Soft ripened cheese (SRC) caused over 130 foodborne illnesses in British Columbia (BC), Canada, during two separate listeriosis outbreaks. Multiple agencies investigated the events that lead to cheese contamination with Listeria monocytogenes (L.m.), an environmentally ubiquitous foodborne pathogen. In both outbreaks pasteurized milk and the pasteurization process were ruled out as sources of contamination. In outbreak A, environmental transmission of L.m. likely occurred from farm animals to personnel to culture solutions used during cheese production. In outbreak B, birds were identified as likely contaminating the dairy plant’s water supply and cheese during the curd-washing step. Issues noted during outbreak A included the risks of operating a dairy plant in a farm environment, potential for transfer of L.m. from the farm environment to the plant via shared toilet facilities, failure to clean and sanitize culture spray bottles, and cross-contamination during cheese aging. L.m. contamination in outbreak B was traced to wild swallows defecating in the plant’s open cistern water reservoir and a multibarrier failure in the water disinfection system. These outbreaks led to enhanced inspection and surveillance of cheese plants, test and release programs for all SRC manufactured in BC, improvements in plant design and prevention programs, and reduced listeriosis incidence.

 DSC00013.JPGMcIntyre, L., Wilcott, L and Naus, M. 2015. Listeriosis outbreaks in British Columbia, Canada, caused by soft ripened cheese contaminated from environmental sources. BioMed Research International, vol. 2015, Article ID 131623, 12 pages, 2015. doi:10.1155/2015/131623.


Listeria monocytogenes linked to whole apples used in commercially produced, prepackaged caramel apples – United States, 2014-2015

To be presented at the U.S. Centers for Disease Control and Prevention’s 64th Annual Epidemic Intelligence Service (EIS) conference April 20-23 in Atlanta.

caramel.appleBackground: Listeria monocytogenes (Lm) infection is the third leading cause of death from foodborne illness in the United States. Lm isolates undergo pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS) to identify disease clusters. In November 2014, two multistate clusters of Lm infections with distinct PFGE patterns were detected. Due to geographic and temporal overlap and a case with co-infection, they were investigated together to identify the source and prevent illnesses.

Methods: Cases were defined as illnesses with highly related Lm strains by WGS reported to PulseNet, the national molecular subtyping network for foodborne disease surveillance, with onset from 10/17/2014 to 2/12/2015. Information was collected on foods consumed in the weeks before illness onset using hypothesis-generating questionnaires and open-ended interviews. Case-patient food exposures were compared with data from listeriosis patients with genetically unrelated Lm using Fisher’s exact test. Traceback was performed to identify the suspect food source. WGS was performed on all case-patient, produce, and environmental isolates.

Results: Thirty-five cases from 12 states and 1 from Canada were identified; 34 patients were hospitalized and seven died. Three cases of meningitis occurred among healthy children. Twenty-eight (90%) of 31 patients reported consuming prepackaged caramel apples (multiple brands) compared with 1 (2.8%) of 36 patients with unrelated Lm isolates (p<0.001). Environmental and produce samples from a common apple supplier were highly related to clinical isolates by WGS. Three caramel apple producers and the apple supplier issued voluntary recalls.

Conclusions: Whole apples used in prepackaged caramel apples were the outbreak source. This is a new vehicle for Lm infections. Research is needed to understand factors specific to caramel apple production to prevent further contamination and illness.

A Journey Through the Past: additional illnesses linked to Blue Bell

Following Blue Bell’s recall of all of their products last night, CDC updated their Blue Bell Creameries investigation website to include two additional illnesses in Arizona and Oklahoma (in 2010 and 2012).MPW-12530

As of April 21, 2015, a total of ten patients infected with several strains of Listeria monocytogenes were reported from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015. The patients with illness onsets ranging from 2010-2014 were identified through a retrospective review of the PulseNet database for DNA fingerprints that were similar to isolates collected from Blue Bell ice cream samples. Since the last update on April 8, 2015, two additional patients, one each from Arizona and Oklahoma, were confirmed to be a part of the outbreak by whole genome sequencing. All ten (100%) patients were hospitalized. Three deaths were reported from Kansas.

What we haven’t heard from Blue Bell is whether they had Listeria issues in their plants in the past, and if so, what they did to address them.

Blue Bell recalls all of their ice cream

According to the Dallas News, Blue Bell has recalled all of the ice cream that they have ever produced throughout their 108-year existence.

The initial recall was announced on March 13 after products manufactured in a Brenham TX plant were linked to a cluster of listeriosis including 3 deaths and 2 illnesses. With additional information came additional recall expansions. And now it’s all the ice cream products.

A message from CEO and President, Paul Kruse on the Blue Bell website states:BLUEBELL_43460737

Through further internal testing, we learned today that Listeria monocytogenes was found in an additional half gallon of ice cream in our Brenham facility. While we initially believed this situation was isolated to one machine in one room, we now know that was wrong. We need to know more to be completely confident that our products are safe for our customers.

As Blue Bell moves forward, we are implementing a procedure called “test and hold” for all products made at all of our manufacturing facilities. This means that all products released will be tested first and held for release to the market only after the tests show they are safe.

In addition to the “test and hold” system, Blue Bell is implementing additional safety procedures and testing including:

-          Expanding our already robust system of daily cleaning and sanitizing of equipment

-          Expanding our system of swabbing and testing our plant environment by 800 percent to include more surfaces (what was it before -ben?)

-          Sending samples daily to a leading microbiology laboratory for testing

-          Providing additional employee training
We are heartbroken about this situation and apologize to all of our loyal Blue Bell fans and customers.  Our entire history has been about making the very best and highest quality ice cream, and we intend to fix this problem.   We want enjoying our ice cream to be a source of joy and pleasure, never a cause for concern, so we are committed to getting this right.

Too bad it takes such a tragic event to lead to the action.

It is embarrassing and deadly: Blue Bell working to get past Listeria contamination scare

Blue Bell Creameries will survive the crisis caused by a recent recall of products prompted by a finding of bacterial contamination in some of its products, but it will take a lot of work and a lot of money, experts said.

blue.bell.creameriesThe U.S. Centers for Disease Control and Prevention reported earlier this month that three people in Texas had the same strain of listeria bacteria linked to some Blue Bell ice cream products previously found in five others at a Wichita, Kansas, hospital. Three of the five in Kansas died. That prompted the first recall in the family-owned creamery’s 108-year history, and some major retail and customer clients pulled all Blue Bell products from their offerings until they could be assured those products were safe.

Consultant Gene Grabowski, who has been a “crisis guru” to food manufacturers in about 150 recalls, has been advising the Brenham, Texas-based creamery, the Austin American-Statesman ( ) reported. Blue Bell, he said, has worked around the clock since the listeria concerns arose to identify and correct any contamination sources.

“This company cares more about the health and well-being of consumers than any company I’ve ever worked for,” he told the newspaper. “This is a company that’ always trying to do the right thing. This has been embarrassing for the family.”

Food safety nonsense from leading Toronto hospital

In 2008, Listeria in Maple Leaf cold-cuts killed 23 Canadians and sickened another 55.

listeria(4)(2)An outbreak of listeria in cheese in Quebec in fall 2008 led to 38 hospitalizations, of which 13 were pregnant and gave birth prematurely. Two adults died and there were 13 perinatal deaths.

A Sept. 2008 report showed that of the 78 residents of the Canadian province of British Columbia who contracted listeriosis in the past six years, 10 per cent were pregnant women whose infections put them at high risk of miscarriage or stillbirth.

The majority — nearly 60 per cent — of pregnant women diagnosed with listeriosis either miscarry or have stillbirths.

In the April 2010 edition of the journal, Canadian Family Physician, the Motherisk team at the previously reputable Toronto Hospital for Sick Children published a piece that said, without any references, that pregnant women need not avoid soft-ripened cheeses or deli meats, so long as they are consumed in moderation and obtained from reputable stores.”


Five years later, the hospital has finally decided to take action.

sick-kids.jpg.size.xxlarge.letterboxBut not because of bogus advice.

The Hospital for Sick Children has permanently discontinued hair drug and alcohol tests at its embattled Motherisk Drug Testing Laboratory after an internal review “further explored and validated” previous, and as yet undisclosed, “questions and concerns.”

The decision, announced on Friday, comes amid a Star investigation and mounting pressure from critics to shutter the lab, whose hair drug and alcohol tests have been used in criminal and child protection cases across the country, typically as evidence of parental substance abuse.

In March, Sick Kids temporarily suspended all non-research operations at Motherisk, after Lang’s review and the hospital’s review revealed new information, pending the results of Lang’s review, which are expected by June 30.

The hospital has declined to elaborate on the nature of that information. A hospital spokeswoman said on Friday that Sick Kids is not taking media inquiries.

Health Minister Eric Hoskins refused to answer questions on why there is so much secrecy surrounding the problems uncovered at Motherisk and instead issued a statement by email about Lang’s review.

“The independent review is ongoing and we have confidence in the work that is being carried out by the Honourable Susan Lang,” he said.

Sick Kids recently temporarily reassigned medical oversight of Motherisk, which also counsels pregnant women on which medications are safe to take, amid questions from the Star about the ties between Motherisk director and founder Gideon Koren and the drug company Duchesnay.

The questions related to the lack of disclosure of the funding Motherisk receives from Duchesnay in a booklet for pregnant women co-written by Koren and featured on the Motherisk website, which heavily promotes the use of Duchesnay’s drug Diclectin to treat morning sickness.

It’s all about trade: CFIA sucks at communication

In 1997, I co-wrote a book called Mad Cows and Mother’s Milk, which included a chapter about how the newly formed Canadian Food Inspection Agency sucked at communication and enforcement regarding bovine spongiform encephalopathy.

mad.cows.mother's.milkA few years later, when Canada had its first case of mad cow disease, the chief vet was proactive, and consumption of beef actually rose.

But when the Maple Leaf listeriosis outbreak killed 23 in 2008, CFIA was left castrated.

It was probably a political thing.

Kelsey Johnson, a reporter with iPolitics, writes in Canada’s Western Producer that there is nothing more frustrating for a journalist than the inability to get basic information for a story from official channels, particularly at the federal level.

The relationship between the federal government and the Parliamentary Press Gallery is especially strained, one that is unlikely to improve much in the coming months thanks to the rapidly approaching federal election.

Which is why the Canadian Food Inspection Agency’s communication response to the single case of H5N2 avian flu in Ontario has been a pleasant surprise.

The CFIA’s last communications effort, which had been prompted by a leak that revealed a case of BSE had been found on an Alberta farm in February, received heavy criticism from some reporters, including yours truly.

In that particular case, obtaining basic information such as the location of the index farm and the birth farm, was like pulling teeth. The agency’s initial plan was to not make the case public until its monthly reporting period in March, a policy that CFIA and the cattle industry insist is simply standard practice.

RS64This time around CFIA appears to have amended its communication strategy.

Reporters were first informed of the single case of avian flu April 7 through a CFIA news release that was sent to the entire Parliamentary Press Gallery. That in itself is an improvement over the BSE case, when the agency put out a response but didn’t send it to the gallery’s main email, which frustrated several reporters who were unaware of the CFIA’s response.

Kelsey, it’s all about trade.

And while is only 20-years-old, the Rolling Stones released their first album, 51 years ago today (thank you, Buddy Holly).


Listeria in raw milk, again

Public health types got other things to do than police the raw milk biz, especially when there is an alternative – pasteurization.

raw.milk.claravale (1)New York State Agriculture Commissioner Richard A. Ball today warned consumers in Sullivan County and the surrounding area not to consume unpasteurized raw farm milk from the Richard Dirie Farm due to possible Listeria contamination.  The Dirie Farm is located at 1345 Shandelee Road, Livingston Manor, New York, 12758.

A sample of the milk, collected by an inspector from the department’s Division of Milk Control and Dairy Services on April 7, 2015 was subsequently tested by the Department’s Food Laboratory and discovered to be contaminated with Listeria monocytogenes.     

On April 9, 2015, the producer was notified of a preliminary positive test result. He volunteered to suspend raw milk sales until the sample results were confirmed.  Further laboratory testing, completed on April 15, 2015, confirmed the presence of Listeria monocytogenes in the raw milk sample.  The producer is now prohibited from selling raw milk until subsequent sampling indicates that the product is free of harmful bacteria.

To date, the department knows of no illnesses associated with this product.