From the duh files: FDA says cows may have caused E. coli lettuce contamination, gumshoes are needed

Lettuce and leafy greens are overrated.

Outbreaks of E. coli illness sickened 188 people last year who ate romaine lettuce in three separate outbreaks.

There have been so many outbreaks going back to spinach in 2006, and beyond that, my favorite salad now is a Greek  salad – without the lettuce.

If the Leafy Greens Marketing Association was as rigorous as its press releases maintain this would be minimized.

Instead, between 2009 and 2018, federal authorities identified 40 food-borne outbreaks of E. coli in the U.S. “with a confirmed or suspected link to leafy greens,” the FDA said.

Investigators concluded the most recent outbreaks were centered on ranches and fields owned by the same grower and that were located downslope from public land where cattle grazed.

So if LGMA is doing internal audits, why didn’t they notice this dude?

Because it’s PR not gumshoes, people out in the field.

We figured out 20 years ago that gumshoes are required.

 The U.S. Food and Drug Administration published the findings of an investigation into the contamination of romaine lettuce implicated in three outbreaks of E. coli O157:H7 during the Fall of 2019.

The investigation was conducted at several farms identified in the outbreak tracebacks, as well as at other businesses and public access areas and resulted in several key findings:

Each of these three outbreaks, identified in the report as Outbreaks A, B and C was caused by distinctly different strains of E. coli O157:H7 as determined by whole genome sequencing (WGS) analysis;

Traceback investigations of multiple illness sub-clusters and supply chain information identified a common grower with multiple ranches/fields which supplied romaine lettuce during the timeframe of interest to multiple business entities associated with all three outbreaks. 

The same strain of E. coli O157:H7 that caused Outbreak A was found in two different brands of fresh-cut salads containing romaine lettuce in 2019;

This same outbreak strain of E. coli O157:H7 in Outbreak A was detected in a fecal–soil composite sample taken from a cattle grate on public land less than two miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations;

Other strains of Shiga toxin-producing E.coli (STEC), while not linked to any of the  outbreaks, were found in closer proximity to where romaine lettuce crops were grown, including two samples from a border area of a farm immediately next to cattle grazing land in the hills above leafy greens fields and two samples from on-farm water drainage basins.

These findings, together with the findings from earlier leafy greens outbreaks dating back to 2013, suggest that a potential contributing factor has been the proximity of cattle—a persistent source of E. coli O157:H7 and other STEC—to the produce fields identified in traceback investigations.

Because of  the reoccurring nature of outbreaks associated with leafy greens, the FDA recently released a 2020 Leafy Greens STEC Action Plan, which outlines a three-pronged approach for tackling this problem.  It describes the FDA’s plans for working with industry, federal partners, state and local regulators, academia and others to address the safety of leafy greens by advancing work in three areas: prevention, response, and addressing knowledge gaps.

Outbreak investigation of E. coli: Romaine from Salinas, California (November 2019)

21.may.20

FDA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-romaine-salinas-california-november-2019

Chipotle: Another gift that keeps on giving, $25 million criminal fine for food poisoning

Chipotle Mexican Grill Inc. will, according to Edvard Pettersson of Bloomberg, pay a $25 million criminal fine to resolve allegations by federal prosecutors that its food sickened more than 1,100 people across the U.S. from 2015 to 2018.

It’s the largest fine ever imposed in a food-safety case, according to a statement by the U.S. attorney’s office in Los Angeles.

The criminal charges pertain in part to norovirus outbreaks at Chipotle restaurants. The highly contagious virus can be transmitted by infected food workers handling ready-to-eat foods and their ingredients, according to the statement. It can cause severe symptoms, including diarrhea, vomiting and abdominal cramping.

“Chipotle failed to ensure that its employees both understood and complied with its food safety protocols, resulting in hundreds of customers across the country getting sick,” U.S. Attorney Nick Hanna said in the statement announcing the deferred-prosecution agreement.

The Newport Beach, California-based company said that, as part of the agreement, it will its strengthen its food-safety polices and practices.

“This settlement represents an acknowledgment of how seriously Chipotle takes food safety every day and is an opportunity to definitively turn the page on past events and focus on serving our customers real food made with real ingredients that they can enjoy with confidence,” Brian Niccol, chairman and chief executive officer of the company, said in a statement.

Prosecutors alleged that four norovirus outbreaks were caused by employees showing up to work sick, in violation of company policy, and by food products being stored at the wrong temperatures.

A fifth outbreak — which sickened about 647 people in July 2018 who dined at a Chipotle in Ohio — was from Clostridium perfringens, a bacterium found in raw meat and poultry that is one of the most common types of foodborne illness in the U.S. People who get ill from it usually recover in 24 hours and it’s not contagious.

Managers at the company’s restaurants failed on a number of occasions to notify Chipotle’s safety group at its headquarters when an employee had been vomiting at work, according to prosecutors. Instead, the safety analysts would find out only after contacting the restaurant because it had received a complaint from a sick customer. As a result, there were days of delay before the restaurants were sanitized.

Australian rockmelon growers get best practice guide to help food safety

Really?

Are these guidelines actually going to make fewer people barf and die?

It’s all about the implementation and verification, but that’s expensive and rarely undertaken beyond soundbites.

When Listeria killed seven people in Australia last year, linked to rockmelon (cantaloupe for you North American types) growers acted like it never happened before and just wanted to get product back on shelves.

They should never be cut in half, although all retailers do it, and it’s just greed over public health.

In the fall of 2011, 33 people were killed and 147 sickened from Listeria linked to cantaloupe in the U.S.

And it keeps happening.

The NSW Department of Primary Industries has released a best practice guide for rockmelons and speciality melons prompted by the 2018 listeria detection on a NSW farm which severely impacted the entire Australian rockmelon industry.

Domestic and export sales ceased for around six weeks. It has taken the following two years to regain market share.

To support rockmelon growers and combat foodborne illness risks, Hort Innovation launched a review of all industry food safety practices to strengthen food safety measures and provide training support for the industry.

Delivered by the NSW Department of Primary Industries (NSW DPI), the project involved working individually with all Australian rockmelon growers to review and audit current practice and critical control points.

One-on-one food safety consultations with growers, managers and key farm staff also took place.

The project also developed a Melon Food Safety Best-Practice Guide and a “toolbox” for grower use including risk assessment templates, training guides, food safety posters and record sheets to support food safety programs.

Four listeria deaths over three years traced to enoki mushrooms

Enoki mushrooms from South Korea have been recalled and investigators are linking them to a multi-year outbreak of Listeria monocytogenes that has killed four people.

The importer, Sun Hong Foods Inc., Montebello, Calif., recalled the mushrooms March 9 after Michigan Department of Agriculture and Rural Development officials found two samples of the mushrooms were positive for the listeria strain.

According to the Centers for Disease Control and Prevention, public health agencies are using the PulseNet system to identify illnesses linked to the outbreak, using “DNA fingerprinting” through whole genome sequencing. 

The agencies did not report when the deaths occurred. Patients in California, Hawaii and New Jersey died.

The cases traced to the mushrooms have a high rate of hospitalization, with 30 of the 36 patients identified requiring hospitalization, according to the Food and Drug Administration, which released a warning to consumers March 10 to not eat any enoki mushrooms from Sun Hong Foods.

Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes, a bacterium which can cause life-threatening illness or death. Consumers are warned not to even if it does not look or smell spoiled.

CDC’s At A Glance concluded:

Reported Cases: 36

States: 17

Hospitalizations: 30

Deaths: 4

Recall: Yes

Outbreak investigation of Listeria monocytogenes: Hard-boiled eggs (December 2019)

Why did Listeria appear in hard-boiled eggs? Insufficient cooking? Cross-contamination? Dirty pails? This report doesn’t say.

The U.S. Food and Drug Administration, the U.S. Centers for Disease Control, CDC, and state and local partners investigated an outbreak of Listeria monocytogenes infections linked to hard-boiled eggs produced by Almark Foods’ Gainesville, Georgia facility. Almark Foods announced an initial voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019, and then on December 23, 2019 expanded the recall to include all hard-boiled eggs produced at the Gainesville, Georgia facility. All recalled products are now past their “best by” dates.

CDC has announced this outbreak is over. FDA’s investigational activities, including an inspection, are complete. At this time, the firm is no longer producing products at this facility.

Recommendation

Recalled products are now past their “best by” dates and should be thrown away.

FDA recommends that food processors, restaurants and retailers who received recalled products use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.

Case Counts

Total Illnesses: 8
Illnesses in 2019: 5
Hospitalizations: 5
Deaths: 1
Last illness isolation date: December 7, 2019
States with Cases: FL (1), ME (2), PA (1), SC (2), TX (2)
States with Cases in 2019: FL (1), ME (2), SC (2), TX (1)
Product Distribution*: Nationwide
*Distribution has been confirmed for states list, but at this time we believe the product was distributed nationwide. Updates will be provided as more information becomes available.

What Products are Recalled?

Recalled products include bulk product sold in pails, as well as products sold at retail. Companies who received recalled product from Almark Foods have initiated recalls of products containing these eggs. A list of all these recalls is available on the FDA website.

 

Lettuce is overrated: FDA’s leafy greens STEC action

I’ll say it again, as a comic in all seriousness: Lettuce is overrated.

My favorite salad is a Greek one with all those veggies and no lettuce.

The U.S. Food and Drug Administration announced last week that between 2009 and 2018, FDA and the Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens.

Holy shit.

This is why The Tragically Hip were so great, and why they never appealed much beyond Canada.

I feel the same about academia.

And why Osterholm called me 15 years ago as a consultant for Fresh Express, and asked me how dare I the lettuce and skull picture, and I said because I can and it was fairly apt given there have been 40 outbreaks.

Holy shit (this is me echoing my John Oliver voice).

Coronavirus is just confirming: Go public, go often, go hard.

It’s the only way people will pay attention.

And as this story in the N.Y. Times points out, there have been spectacular public health failures by people who tell others, just shut the fuck up.

According to the FDA, it has an unwavering commitment to advancing the safety of fresh leafy greens. Leafy greens are among the most widely consumed vegetables and an important part of an overall healthy diet. While millions of servings are consumed safely every day, this produce commodity has been implicated too often in outbreaks of foodborne illness, and we believe that FDA, along with leafy greens sector stakeholders, can do more.

Between 2009 and 2018, FDA and Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens. While most strains of E. coli are harmless, STEC can cause bloody diarrhea, anemia, blood-clotting problems, and kidney failure – conditions that are potentially life-threatening. The most common STEC, E. coli O157:H7, is the type most often associated with outbreaks.

Most leafy greens are grown outdoors, where they are exposed to soil, animals, and water, all of which can be a source of pathogen contamination. In addition, leafy greens are mostly consumed raw, without cooking or other processing steps to eliminate microbial hazards. The Produce Safety Rule under the FDA Food Safety Modernization Act (FSMA) sets science-based standards to help ensure that water, soil amendments (e.g., fertilizer or compost), food contact surfaces and other materials that touch produce during growing, harvesting, packing, and holding do not contribute to produce contamination. The Produce Safety Rule also addresses animal intrusion into fields and worker hygiene.

Due to the recurring nature of outbreaks associated with leafy greens, FDA has developed this commodity-specific action plan. What follows is an overview of the actions FDA plans to take in 2020 to advance work in three areas: (1) prevention, (2) response, and (3) addressing knowledge gaps.

It’s not a war: FDA arming itself with science to help prevent Cyclospora infections

Steven Musser Ph.D., Deputy Director for Scientific Operations, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Alexandre da Silva, Ph.D., Lead Parasitologist at CFSAN’s Office of Applied Research and Safety Assessment, write that Cyclospora cayetanensis is so small that it can only be seen with a microscope. However, there is nothing small about the U.S. Food and Drug Administration’s work to help protect consumers from the foodborne illness that this parasite can cause.

Of course it’s small. So are the trillion of microorganisms inside each of us.

Cyclospora has been on the public radar since at least 1996.

Cyclosporiasis is an intestinal illness caused by consumption of foods, mainly fresh produce, that are contaminated with Cyclospora. The FDA has been working to help prevent contaminated product from reaching consumers, gathering the scientific knowledge that will help to better detect the parasite in food and the environment, and gathering data to better understand how food is contaminated by the parasite and help prevent contamination in the future. We’re also sharing what we know with stakeholders in the public and private sectors.

Because several past outbreaks have been associated with fresh herbs, the FDA has been conducting surveillance sampling of fresh cilantro, parsley and basil. A quarterly update on this food surveillance study was released today. As this effort continues, our goal is to collect enough samples to provide a precise estimate of the prevalence of contamination of Cyclospora in our food supply, enabling us to better understand our vulnerability to Cyclospora contamination.     

The FDA is also acting on what we already know about where Cyclospora is found and how contamination can be prevented.   

In 2019, 10% of the Cyclospora infections reported between May and August were linked to a multi-state outbreak associated with fresh imported basil that started in mid-June and was declared over in October. FDA increased its screening at the border of basil exported by the company tied to the outbreak before the company voluntarily recalled its product and ceased shipping while corrective measures were implemented.

The FDA is also tracking contamination in domestically-grown produce. The first confirmed evidence of Cyclospora in domestically grown produce was detected in 2018 in cilantro, a finding not associated with an outbreak of illnesses. As with bacterial pathogens, if the parasite is found on produce, the FDA follows up with inspections and sampling, working with the business to take the actions needed to protect public health.

The FDA has been reaching out to farmers to increase awareness of Cyclospora and actions that can be taken on the farm to reduce the likelihood of contamination. For example, ways to control sources of contamination include proper use, maintenance and cleaning of toilet and handwashing facilities. We created education and outreach materials for farmers, including the Cyclosporiasis and Fresh Produce Fact Sheet

In late 2014, the FDA’s Center for Food Safety and Applied Nutrition established a Foodborne Parasitology Research Program, and in collaboration with the CDC, has been sequencing the genomes of several different strains of C. cayetanensis, enabling the development of genetic typing methods. In 2016, we created a genome database named “CycloTrakr” to be used as a public repository of genomic data at the National Center for Biotechnology Information (NCBI). This is an important first step towards the goal of linking, in real-time, the genetic fingerprints of Cyclospora in contaminated food and sick people to pinpoint the source of the outbreaks.

The agency has also pioneered ways to detect the parasite, developing and validating new methods to test for Cyclospora in produce and water. The first of these new methods was used for the first time in 2018 to confirm the presence of the parasite in a salad mix product tied to an outbreak that sickened hundreds of people. 

In July 2019, the FDA made its second major advance in Cyclospora detection, completing studies that resulted in a novel, validated method to test agricultural water for the presence of the parasite. Water used on farms is a potential source of the contaminants that cause foodborne illnesses. Analysts from FDA laboratories are being trained in the use of this method for regulatory testing. 

From the duh files: Corinthian Foods recalls fish nuggets mislabeled as chicken nuggets

Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The product is packaged in clear 5 lb. bags with a white label with black writing.

Product was distributed in the state of Michigan, and may reach consumers through retail stores.

All allergens are properly declared, and no illness have been reported.

The problem was discovered when cases were opened to put out for retail sale, and the label on the retail package did not match the label and description of the master case. Subsequent investigation indicates the problem was caused during the packaging process. The incorrect labels were applied to the product causing the product to be mislabeled.

Nestle invests $200 million more in Aimmune after peanut allergy drug approval

Saumya Joseph of Reuters reports Aimmune Therapeutics Inc said on Wednesday the health science arm of Nestle SA will invest an additional $200 million, days after the drugmaker won U.S. approval for its peanut allergy therapy, touted as a potential blockbuster.

The funding brings Nestle’s total investment to $473 million, increasing the Swiss company’s stake to 19.9% of Aimmune’s outstanding stock and voting power.

Aimmune shares rose 5.7% in early morning trading, after falling 11% on Tuesday. Its therapy, Palforzia, was approved on Friday after markets close.

Nestle’s investment is an incremental positive for Aimmune’s shares, which have seen some weakness due to investor worries over financing, Piper Sandler analyst Christopher Raymond wrote in a note.

“With this additional investment, we think the prospect of an outright take out by Nestle (or anyone else for that matter) has to be factored in more than before,” Raymond said.

Nestle has been trying to become a “nutrition, health and wellness” company, with its Nestle Health Science unit playing a pivotal role, as packaged food sales slow amid changing tastes.

The unit invested $145 million in Aimmune in 2016, followed by $30 million as part of the drugmaker’s public offering in February 2018, and another $98 million in November 2018.

Aimmune would use the latest Nestle investment to fund the launch of Palforzia, which is the first approved therapy for reducing and potentially eliminating allergic reactions to peanuts in children.

FDA warns Purell to stop making ‘unproven’ claims that sanitizer can eliminate Ebola

WTKR reports that the U.S. Food and Drug Administration has issued a warning to the maker of Purell hand sanitizer to stop making unproven claims that the product can help eliminate diseases like Ebola, MRSA and the flu.

According to CNN, the FDA’s director of compliance sent a “warning letter” to Gojo, Purell’s parent company, to stop making unproven claims for marketing purposes that could position the hand sanitizer as a pharmaceutical drug.

The letter from the FDA reportedly notes that Purell says on its website and on social media that the sanitizer “kills more than 99.99% of the most common germs that may cause illness in a healthcare setting, including MRSA & VRE.” Purell and Gojo also note that “Purell Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug resistant clinical strain of Candida auris in lab testing.

Finally, the FDA chastized Purell for claiming on the Q&A section on its website that the product can be “effective against viruses such as the Ebola virus, norovirus and influenza.” The FDA says it is not aware of any hand sanitizers that have been tested against Ebola.