Bayer gets lift in pre-trial ruling ahead of Roundup cancer trial

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A California judge gave Monsanto and its German owner Bayer AG a pre-trial boost in a ruling issued Monday, a week before the scheduled start of a new courtroom challenge to the safety of Monsanto’s Roundup herbicides.

Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California agreed with Monsanto that federal law regarding pesticide regulation and labeling preempts “failure to warn” claims under state law, and the plaintiff in the trial set to start next week will not be allowed to pursue such claims.

“The Court grants Defendant Monsanto Motion for Summary Adjudication of the 2nd and 4th causes of action on the grounds the failure to warn or concealment of glyphosate’s link to cancer is expressly and/or impliedly preempted” by federal law, Ochoa wrote in his order.

The decision was “surprising” to plaintiff’s attorney Fletcher Trammell, who is representing plaintiff Donnetta Stephens in the case against Monsanto. “Obviously we disagree,” he said. The issue could be subject of appeal at some point, he added.

The claims that Monsanto made an unsafe product and knowingly pushed it into the marketplace remain intact and will be presented at trial, according to Trammell.

More Than Two Years

It’s been more than two years since Bayer has had to defend the safety of Monsanto’s weed killing products at a trial. Monsanto has lost three out of three previous trials, with a jury in the last trial ordering a staggering $2 billion in damages due to what the jury saw as egregious conduct by Monsanto in failing to warn users of evidence – including numerous scientific studies – showing a connection between its products and cancer.

Lawyers for Stephens, a regular user of Roundup herbicide for more than 30 years, will try to prove that exposure to the glyphosate-based products made popular by Monsanto caused Stephens to develop non-Hodgkin lymphoma (NHL).

The case is set for trial Monday July 26, delayed by one week as the court deals with a variety of pre-trial motions.  Stephens was diagnosed with NHL in 2017 and has suffered from numerous health complications amid multiple rounds of chemotherapy since then. Because of her poor health,  a judge in December granted Stephens a trial “preference,” meaning her case was expedited, after her lawyers informed the court that Stephens is “in a perpetual state of pain,” and losing cognition and memory.

Several other cases have either already been granted preference trial dates or are seeking trial dates for other plaintiffs, including at least two children, suffering from NHL the plaintiffs allege was caused by exposure to Roundup products.

Monsanto was purchased by Bayer AG in 2018 and is no longer a stand-alone company but is the named defendant in ongoing litigation, which began in 2015 after cancer experts consulted by a unit of the World Health Organization determined glyphosate is a probable human carcinogen with a particular association to NHL.

Roughly 100,000 people in the United States have claimed they developed NHL because of their exposure to Roundup or other Monsanto-made glyphosate-based herbicides.

Preemption Argument

Bayer sees the preemption argument as critical to its ability to limit the ongoing litigation liability. The company has made it clear that it hopes at some point to get a U.S. Supreme Court finding that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency’s (EPA) position that Monsanto’s herbicides are not likely to cause cancer essentially bars complaints that Monsanto didn’t warn of any cancer risk.

Critics of that position point to a 2005 U.S. Supreme Court ruling in a case titled Bates v. Dow Agrosciences, which established that the EPA’s approval of a product does not rule out claims of a failure to warn brought under state law. Citing the law and the Bates precedent, more than a dozen federal and state courts have rejected the preemption argument.

But some legal experts argue the rejections of the preemption argument in the Roundup litigation are flawed and believe Bayer has a solid defense on that issue.

If Bayer can ultimately get a U.S. Supreme Court win on the preemption question, it could thwart the key claims brought by tens of thousands of plaintiffs and potentially save Bayer from significant ongoing legal liability costs.

In the first trial against Monsanto, a unanimous jury awarded plaintiff Dewayne Johnson $289 million; the plaintiff in the second trial was awarded $80 million; and the jury in the third trial awarded more than $2 billion to husband-and-wife plaintiffs. All the awards were reduced sharply by judges involved in the cases but the verdicts assigning blame to Monsanto for the cancers have not been overturned.

Bayer settlement

Bayer said last year that it had agreed to pay close to $11 billion to settle existing Roundup cancer claims, but many law firms have dismissed the individual offers for their clients as insufficient, and they continue to press for more trials.

Additionally, Bayer has thus far failed to get court approval for varying proposals to try to create a class action settlement program for people who bring cancer claims in the future. After a stinging rebuke of its plans by a federal judge overseeing much of the litigation, Bayer said it is considering pulling Roundup products from the U.S. market for residential users, though not from farm use.

The case is Stephens v. Monsanto CIVSB2104801 in the Superior Court of California – County of San Bernardino.

New analysis of glyphosate industry studies finds them outdated, flawed

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See Carey Gillam’s article in The Guardian, Corporate studies asserting herbicide safety show many flaws, new analysis finds (July 2, 2021). In this post we provide links to the 53 once-secret studies and related materials. 

Questions about the safety of glyphosate-based herbicides (GBHs) have persisted for years, as scientific research has split over whether or not the widely used weed killing chemical introduced by Monsanto in the 1970s causes cancer or other human health problems.

A number of independent studies show links between glyphosate herbicides and cancer and other health problems, leading the International Agency for Research on Cancer in 2015 to classify glyphosate as a probable human carcinogen.

But Monsanto, purchased by Bayer AG in 2018, has maintained glyphosate is not carcinogenic, nor does it cause other health problems when used as directed. Other large chemical companies that sell glyphosate or related products echo Monsanto’s safety assurances.

Regulators in Europe and the United States, Canada and elsewhere have affirmed the corporate assertions of glyphosate safety. They point to decades of tests conducted by or for the companies that have not been published but which regulators have reviewed, as well as published studies in the scientific literature.

The corporate studies have long been kept secret, even by regulators. But in Europe, litigation by a group of European Parliament lawmakers led to the release of dozens of such studies.

A consumer advocacy group, SumOfUs, provided more than 50 studies to two independent scientists for review – Armen Nersesyan and Siegfried Knasmueller, both from the Institute of Cancer Research, Department of Medicine at the Medical University of Vienna.

Knasmueller, the lead author, is an expert in genetic toxicology and along with his work at the cancer institute is editor-in-chief of two prominent scientific journals, including Mutation Research – Genetic Toxicology and Environmental Mutagenesis.

The goal of the evaluation was to determine if the industry studies examined comply with current international guidelines for chemical testing. The studies are those concerning the genotoxic properties of glyphosate.

The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines. An array of shortcomings and flaws were found in the studies, rendering most of them unreliable, according to the analysis.

In fact, of the 53 studies submitted to regulators by the companies, only two were acceptable under current internationally recognized scientific standards, said Knasmueller.

Knasmueller said there are more reliable methods for detecting carcinogens but those were not used in the industry tests. Read the evaluation here. 

Regulatory renewal sought

The analysis of the older studies comes as the companies that sell glyphosate products are seeking reauthorization in Europe and trying to fight against calls for restrictions and bans on glyphosate across the globe.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Bayer.

Bayer confirmed that the older studies were included in the new dossier given to European regulators, but said the GRG was “required to submit all genotoxicity studies that have been conducted, including those submitted in past registration review cycles.” The company said the dossier also includes “new genotoxicity studies conducted since the previous re-approval of glyphosate and a vast review of thousands of published scientific publications regarding glyphosate.”

The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

 The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are organizing public consultations to start in September.

The Knasmueller analysis drew both criticism and support from a mix of scientists who reviewed the work. Here are two comments:

Paul Demers,  director of the Occupational Cancer Research Centre, Ontario Health, in Canada:

The classification of the carcinogenicity of glyphosate has been particularly contentious with international bodies disagreeing not only on areas of interpretation but even on which studies to consider. The critical evaluation, using the latest OECD criteria, of 53 studies submitted to Bundesinstitut für Risikobewertung and European Food Safety Authority is a valuable contribution to the ongoing debate on the carcinogenicity of glyphosate. The observation by the authors that few of these studies met the OECD criteria should be considered by regulatory authorities tasked with protecting workers and the public. Personally, I agree with the approaches for evaluation taken by the International Agency for Research on Cancer, which were used for glyphosate. That said, I also believe that there needs to room for scientific debate and disagreements on issues of interpretation, criteria for evaluation, and even what studies to include. However, there should not be a debate on transparency when it comes to the evidence considered by public bodies in determining the safety of chemicals.  Studies of health effects, with sufficient details regarding the methods used and the results, need to be accessible and open to the critical eyes of the scientific community and other concerned parties.” 

Raymond Tice, retired scientist, U.S. National Institute of Environmental Health Sciences, former  President of the U.S. Environmental Mutagen Society: “An analysis of the experimental data supporting the safety of any chemical should be conducted using systematic review methodology… which takes into account not only the completeness of the information but also categorizes the risk of bias, whether positive or negative.  Clearly, this was not conducted by EFSA or by Dr. Knasmueller.  In general, it is not appropriate to disregard all studies that do not meet current standards, but rather to consider the results in terms of their limitations. Overall, It seems to me that Knasmueller is selective (i.e., exhibits bias) in what he presents and does not present. At the same time, I would fault EFSA for not doing due diligence in what they considered…  Also, I agree that there is a suggestion that (glyphosate) is linked to the induction of oxidative stress which can result in DNA damage (i.e., oxidative stress is one of the key characteristics of carcinogens) but would be expected to have a threshold below which damage is not likely to result in an adverse effect.”

Once-secret studies

See the full analysis, authors’ comments, industry summaries, a list of studies submitted for the current European Union re-authorization, and links to 53 previously secret corporate glyphosate studies below:

Reference-List-of-Glyphosate-Studies-submitted-for-the-Renewal-of-Approval-AIR5-of-Glyphosate-in-2020-EN

European Assessment Group on Glyphosate report on glyphosate renewal

Evaluation of the scientific quality of industry studies of genotoxic properties of glyphosate

Comments concerning the mutagenic/genotoxic properties of glyphosate

Toxicological and Metabolism Studies summary by industry

Albaugh 2014 glyphosate reverse mutation assay Switzerland

Syngenta 2012 glyphosate technical micronucleus assay in bone marrow cells of the mouse

Dow Chemical 2012 Micronucleus test of glyphosate TGAI in mice

Industrias Afrasa 2012 reverse mutation with glyphosate

Helm 2010 Reverse Mutation Assay glyphosate using bacteria

Helm 2010 reverse mutation assay 

Helm 2010 mutagenicity of glyphosate testing

Helm 2009 mutagenicity study of glyphosate Germany

Helm 2009 Micronucleus test of glyphosate in bone marrow cells of rat

Syngenta 2009 glyphosate reverse mutation

Jingma Chemicals China 2008 evaluation of the mutagenic potential of glyphosate by reverse mutation assay 

Jingma 2008 evaluation of mutagenic potential of glyphosate by micronucleus assay in mice

Syngenta 2008 glyphosate micronucleus assay in bone marrow cells of the mouse

Helm 2007 Mammalian erythrocyte micronucleus test for glyphosate

Helm Do Brasil 2007 Bacterial reverse mutation test glyphosate

Nufarm 2007 reverse mutation glyphosate technical 05068

Nufarm 2007 1061403 reverse mutation glyphosate technical 05067

Nufarm 2007 1061402 reverse mutation glyphosate technical 05070 

Nufarm 2005 glyphosate technical micronucleus test in the mouse

Monsanto 1998 Mouse micronucleus screening assay of MON-0818

Zeneca Glyphosate 1998 acid Invitro 

Cheminova 1996 reverse mutation glyphosate Brazil

Cheminova 1996 A micronucleus study in mice for the product GILFOS

Zeneca 1996 glyphosate mutagenicity potential

Zeneca 1996 Glyphosate acid mouse bone marrow micronucleus test

Zeneca 1996 glyphosate acid mouse lymphoma gene mutation assay

Sanko 1995 glyphosate in vitro cytogenetics

Sanko 1995 glyphosate DNA Repair Test

Sankyo 1995 reverse mutation study 

Mastra and Maruzen Kako 1995 Technical glyphosate

Mastra and Maruzen Kako 1995 reverse mutation assay glyphosate

Agrichem 1995 Evaluation of ability of glyphosate to induce chromosome aberrations

Feinchemie Schwebda 1994 DNA repair test with primary rat hepatocytes

Feinchemie Schwebda 1994 in vivo mammalian bone marrow cytogenetic test

Feinchemie Schwebda 1993 Mutagenicity-micronucleus glyphosate test in swiss albino mice

Feinchemie Schwebda 1992 Dominant lethal test in Wistar rats

Monsanto 1992 Mouse micronucleus study of Roundup

Monsanto 1992 glyphosate mutagenicity assay on Roundup

Monsanto 1992 Mouse micronucleus study of RODEO glyphosate formulation

Monsanto 1992 glyphosate mutagenicity assay on RODEO herbicide

Monsanto 1992 mouse micronucleus study of DIRECT formulation

Monsanto 1992 glyphosate mutagenicity potential DIRECT brand

Hoechst Dodigen 4022 1992 study of mutagenic potential in strains of salmonella and E Coli

Hoechst Dodigen 4022 1992 Chromosome aberrations in vitro in V79 Chinese hamster cells

Cheminova 1991 #12323 glyphosate mutagenicity test

Cheminova 1991 #12324 Mutagenicity test micronucleus glyphosate

Cheminova 1991 #12325 glyphosate mutagenicity test in vitro mammalian cell gene mutation test

Monsanto 1990 Ames Salmonella mutagenicity assay of MON 0818

Monsanto 1983 In vivo bone marrow cytogenetics study of glyphosate in Sprague-Dawley rats

Monsanto 1983 glyphosate gene mutation assay

Monsanto 1981 Ames salmonella mutagenicity assay of MON 8080

Monsanto 1980 Dominant lethal mutagenicity assay with technical glyphosate in mice

Institute of Environmental Toxicology 1978 Glyphosate report of mutagenic study with bacteria

Paraquat Papers

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Multiple lawsuits are pending in the United States alleging the weedkilling chemical paraquat causes Parkinson’s disease, and the first case to go to trial over the allegations against Syngenta over paraquat and Parkinson’s was originally scheduled for April 12 but was rescheduled for May 10 in St. Clair County Circuit Court in Illinois and then was delayed again until June 1 and then was called off on May 28.  The parties reportedly settled the case.

A notice of settlement was filed June 18, 2021 for several paraquat cases. See this document.

There are dozens of lawsuits pending against Syngenta alleging the company’s paraquat products cause Parkinson’s Disease. The Hoffman case also names Chevron Phillips Chemical Co. and Growmark Inc. as defendants. Chevron distributed and sold Gramoxone paraquat product in the United States in an agreement with a Syngenta predecessor called Imperial Chemical Industries (ICI), which introduced paraquat-based Gramoxone in 1962. Under a license agreement, Chevron had the right to to manufacture, use, and sell paraquat formulations in the U.S.

Lawyers around the United States are advertising for plaintiffs, seeking to draw in thousands of people who’ve been exposed to paraquat and now suffer from Parkinson’s.

Some of  the most recently filed cases were brought in federal courts in California and Illinois. Among those cases are Rakoczy V. Syngenta,  Durbin V. Syngenta and Kearns V. Syngenta.

On April 7, 2021, the Fears Nachawati Texas-based law firm filed a motion with the U.S. Judicial Panel on Multidistrict Litigation in Washington, D.C., asking that pending paraquat lawsuits be consolidated for pretrial proceedings in the Northern District of California, the same federal court where Roundup litigation was consolidated. The case with the judicial panel is MDL No. 3004. The panel hearing on the matter was May 27 and on June 7, the panel approved the formation of the paraquat multidistrict litigation, assigning it to Judge  Nancy J. Rosenstengel in the Southern District of Illinois.

Additionally, a class action lawsuit was filed in federal court in Iowa on May 3. The suit seeks “equitable relief in the form of medical monitoring, including, but not limited to, the costs of diagnostic testing” for farmers and others exposed to paraquat who are allegedly at “increased risk” for Parkinson’s, according to the legal filing.

Several scientific studies have linked paraquat to Parkinson’s, including a large study of U.S. farmers jointly overseen by multiple U.S. government agencies.  Farmers use paraquat in the production of many crops, including corn, soy and cotton. The Agricultural Health Study (AHS) said it found that “exposure to agricultural pesticides may increase a person’s risk of developing Parkinson’s disease.” In 2011, AHS researchers reported that “participants who used paraquat or rotenone were twice as likely to develop Parkinson’s disease as people who didn’t use these chemicals.”

A more recent paper from AHS researchers stated that “Extensive literature suggests an association between general pesticide use and Parkinson’s disease (PD). However, with few exceptions, little is known about associations between specific pesticides and PD.”

Parkinson’s is an incurable progressive nervous system disorder that limits a person’s ability to control movement, causing tremors, loss of balance and eventually often leaving victims bedridden and/or bound to a wheelchair. The disease is not necessarily fatal but typically becomes severely debilitating.

Dutch neurologist Bastiaan Bloem, who recently authored a book about Parkinson’s, blames widespread exposure to herbicides such as paraquat, along with other toxic chemicals used in agriculture and manufacturing, for the spread of the disease.

Acutely Toxic 

Along with fears about links between paraquat and Parkinson’s, paraquat is also known to be an extremely acutely toxic chemical that can quickly kill people who ingest very small amounts. In Europe, the sale of paraquat has been banned since 2007, but in the United States the pesticide is sold as a “Restricted Use Pesticide” due to “acute toxicity.”

As part of discovery in the Parkinson’s litigation, lawyers have obtained internal records from Syngenta and its predecessor corporate entities dating back to the 1960s. Many of these documents are sealed, but some have started to come to light.

Those unsealed discovery documents, which include copies of letters, minutes of meetings, study summaries, and emails, are being made available on this page.

Most of the documents unsealed to date deal with corporate discussions about how to keep paraquat herbicides on the market despite its deadliness, through measures designed to reduce accidental poisonings. Specifically, many of the documents detail an internal corporate struggle over the addition of an emetic, a vomit-inducing agent, to paraquat products.  Today, all Syngenta paraquat-containing products include an emetic called “PP796.”  Liquid paraquat-containing formulations from Syngenta also include a stenching agent to produce a foul odor, and a blue dye to differentiate the dark-colored herbicide from tea or cola or other beverages.

EPA Review 

Paraquat is currently undergoing the EPA’s registration review process, and on Oct. 23, 2020, the agency  released a proposed interim decision (PID) for paraquat, which proposes mitigation measures to reduce human health and ecological risks identified in the agency’s 2019 draft human health and ecological risk assessments.

The EPA said that through collaboration with the National Toxicology Program at the National Institute of Environmental Health Sciences, the agency completed a “thorough review” of the scientific information on paraquat and Parkinson’s Disease and concluded that the weight of evidence was insufficient to link paraquat to Parkinson’s disease. The agency published this “Systematic Review of the Literature to Evaluate the Relationship between Paraquat Dichloride Exposure and Parkinson’s Disease.”

USRTK will add documents to this page as they become available.

Glyphosate Fact Sheet: Cancer and Other Health Concerns

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Glyphosate, a synthetic herbicide patented in 1974 by the Monsanto Company and now manufactured and sold by many companies in hundreds of products, has been associated with cancer and other health concerns. Glyphosate is best known as the active ingredient in Roundup-branded herbicides, and the herbicide used with “Roundup Ready” genetically modified organisms (GMOs).

Herbicide tolerance is the most prevalent GMO trait engineered into food crops, with some 90% of corn and 94% of soybeans in the U.S. engineered to tolerate herbicides, according to USDA data. A 2017 study found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. Here are some key facts about glyphosate:

Most Widely Used Pesticide

According to a February 2016 study, glyphosate is the most widely used pesticide: “In the U.S., no pesticide has come remotely close to such intensive and widespread use.” Findings include:

  • Americans have applied 1.8 million tons of glyphosate (or 1.6 billion kilograms) since its introduction in 1974 to 2014. 
  • Worldwide 9.5 million tons (or 8.6 billion kilograms) of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world, according to an examination of data from 1994-2014.
  • Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced. 
  • Approximately 281 million pounds of glyphosate was applied to 298 million acres annually in U.S. agricultural settings, on average, from 2012 to 2016, according to the Environmental Protection Agency. Most glyphosate was applied to soybean (117.4 million lbs applied annually), corn (94.9 million lbs applied annually), and cotton (20 million lbs applied annually). Many citrus fruits, including grapefruit, oranges, and lemons, and field crops such as soybeans, corn, and cotton have  high percentages of their acres treated with glyphosate. Approximately 24 million pounds of glyphosate are applied to non-agricultural sites annually, on average, from 2012 through 2016, according to EPA.  The majority of non-agricultural use is in the homeowner market. About 5 million lbs is applied annually for residential use.

Statements from scientists and health care providers 

Cancer Concerns

The scientific literature and regulatory conclusions regarding glyphosate and glyphosate-based herbicides show a mix of findings, making the safety of the herbicide a hotly debated subject. 

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” after reviewing years of published and peer-reviewed scientific studies. The team of international scientists found there was a particular association between glyphosate and non-Hodgkin lymphoma.

U.S. agencies: At the time of the IARC classification, the Environmental Protection Agency (EPA) was conducting a registration review. The EPA’s Cancer Assessment Review Committee (CARC) issued a report in September 2016 concluding that glyphosate was “not likely to be carcinogenic to humans” at doses relevant to human health. In December 2016, the EPA convened a Scientific Advisory Panel to review the report; members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research. Additionally, the EPA’s Office of Research and Development determined that EPA’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate, and said the evidence could be deemed to support a “likely” carcinogenic or “suggestive” evidence of carcinogenicity classification. Nevertheless the EPA issued a draft report on glyphosate in December 2017 continuing to hold that the chemical is not likely to be carcinogenic. In April 2019, the EPA reaffirmed its position that glyphosate poses no risk to public health. But earlier that same month, the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) reported that there are links between glyphosate and cancer. According to the draft report from ATSDR, “numerous studies reported risk ratios greater than one for associations between glyphosate exposure and risk of non-Hodgkin’s lymphoma or multiple myeloma.” 

The EPA issued an Interim Registration Review Decision in January 2020 with updated information about its position on glyphosate, continuing to hold the position that glyphosate is unlikely to cause cancer. 

European Union: The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. A March 2017 report by environmental and consumer groups argued that regulators relied improperly on research that was directed and manipulated by the chemical industry. A 2019 study found that Germany’s Federal Institute for Risk Assessment report on glyphosate, which found no cancer risk, included sections of text that had been plagiarized from Monsanto studies.  In February 2020, reports surfaced that 24 scientific studies submitted to the German regulators to prove the safety of glyphosate came from a large German laboratory that has been accused of fraud and other wrongdoing.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Monsanto owner Bayer AG. The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

WHO/FAO Joint Meeting on Pesticide Residues determined in 2016 that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, but this finding was tarnished by conflict of interest concerns after it came to light that the chair and co-chair of the group also held leadership positions with the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.

California OEHHA: On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed it would add glyphosate to California’s Proposition 65 list of chemicals known to cause cancer. Monsanto sued to block the action but the case was dismissed. In a separate case, the court found that California could not require cancer warnings for products containing glyphosate. On June 12, 2018, a U.S. District Court denied the California Attorney General’s request for the court to reconsider the decision. The court found that California could only require commercial speech that disclosed “purely factual and uncontroversial information,” and the science surrounding glyphosate carcinogenicity was not proven.

Agricultural Health Study: A long-running U.S. government-backed prospective cohort study of farm families in Iowa and North Carolina has not found any connections between glyphosate use and non-Hodgkin lymphoma, but the researchers reported that “among applicators in the highest exposure quartile, there was an increased risk of acute myeloid leukemia (AML) compared with never users…” The most recent published update to the study was made public in late 2017.

Recent studies linking glyphosate to cancer and other health concerns 

Cancer

Endocrine disruption, fertility and reproductive concerns 

Liver disease 

  • A 2017 study associated chronic, very low-level glyphosate exposures to non-alcoholic fatty liver disease in rats. According to the researchers, the results “imply that chronic consumption of extremely low levels of a GBH formulation (Roundup), at admissible glyphosate-equivalent concentrations, are associated with marked alterations of the liver proteome and metabolome,” the biomarkers for NAFLD.

Microbiome disruption

  • November 2020 paper in the Journal of Hazardous Materials reports that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. With a “large proportion” of bacteria in the gut microbiome susceptible to glyphosate, the intake of glyphosate “may severely affect the composition of the human gut microbiome,” the authors said in their paper. 
  • A 2020 literature review of glyphosate’s effects on the gut microbiome concludes that, “glyphosate residues on food could cause dysbiosis, given that opportunistic pathogens are more resistant to glyphosate compared to commensal bacteria.” The paper continues, “Glyphosate may be a critical environmental trigger in the etiology of several disease states associated with dysbiosis, including celiac disease, inflammatory bowel disease and irritable bowel syndrome. Glyphosate exposure may also have consequences for mental health, including anxiety and depression, through alterations in the gut microbiome.”
  • A 2018 rat study conducted by the Ramazzini Institute reported that low-dose exposures to Roundup at levels considered safe significantly altered the gut microbiota in some of the rat pups.
  • Another 2018 study reported that higher levels of glyphosate administered to mice disrupted the gut microbiota and caused anxiety and depression-like behaviors.

Harmful impacts bees and monarch butterflies

Cancer lawsuits

More than 42,000 people have filed suit against Monsanto Company (now Bayer) alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma (NHL), and that Monsanto covered up the risks. As part of the discovery process, Monsanto has had to turn over millions of pages of internal records. We are posting these Monsanto Papers as they become available. For news and tips about the ongoing legislation, see Carey Gillam’s Roundup Trial Tracker. The first three trials ended in large awards to plaintiffs for liability and damages, with juries ruling that Monsanto’s weed killer was a substantial contributing factor in causing them to develop NHL. Bayer is appealing the rulings. 

Monsanto influence in research: In March 2017, the federal court judge unsealed some internal Monsanto documents that raised new questions about Monsanto’s influence on the EPA process and about the research regulators rely on. The documents suggest that Monsanto’s long-standing claims about the safety of glyphosate and Roundup do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science

More information about scientific interference

Sri Lankan scientists awarded AAAS freedom award for kidney disease research

The AAAS has awarded two Sri Lankan scientists, Drs. Channa Jayasumana and Sarath Gunatilake, the 2019 Award for Scientific Freedom and Responsibility for their work to “investigate a possible connection between glyphosate and chronic kidney disease under challenging circumstances.” The scientists have reported that glyphosate plays a key role in transporting heavy metals to the kidneys of those drinking contaminated water, leading to high rates of chronic kidney disease in farming communities. See papers in  SpringerPlus (2015), BMC Nephrology (2015), Environmental Health (2015), International Journal of Environmental Research and Public Health (2014). The AAAS award had been suspended amidst a fierce opposition campaign by pesticide industry allies to undermine the work of the scientists. After a review, the AAAS reinstated the award

Desiccation: another source of dietary exposures 

Some farmers use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate.

Glyphosate in food: U.S. drags its feet on testing

The USDA quietly dropped a plan to start testing food for residues of glyphosate in 2017. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate in April 2017. But the agency killed the project before it started. The U.S. Food and Drug Administration began a limited testing program in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.

Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here is a recap of news about glyphosate found in food:

Pesticides in our food: Where’s the safety data?

USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See “Chemicals on our food: When “safe” may not really be safe: Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned,” by Carey Gillam (11/2018).

Another delay for trial set to examine allegation that Syngenta weed killer causes Parkinson’s

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A highly anticipated first-ever trial pitting a group of farmers against the global agricultural giant Syngenta AG over allegations that Syngenta’s paraquat weed killer causes Parkinson’s disease has been delayed again and may not take place at all, according to sources close to the case.

The trial in the case of Hoffman V. Syngenta was scheduled to start June 1 in St. Clair County Circuit Court in Illinois before Associate Judge Kevin Hoerner. Previously it was set to begin May 10, and prior to that it had a trial date in April.

The cancellation of the June 1 trial date came amid speculation that the parties are deep into settlement talks. No new trial date has yet been set, according to a St. Clair County Circuit Court clerk.

The plaintiffs in the case developed Parkinson’s after repeated exposure to paraquat products, specifically Syngenta’s widely used Gramoxone brand. Three of the original plaintiffs in the case have died, including plaintiff Thomas Hoffman.

The trial was to be livestreamed by Courtroom View Network, and plaintiffs’ attorney Steve Tillery had vowed to unveil decades of internal corporate documents he said would show Syngenta knew its paraquat-based weed killer causes Parkinson’s disease, a disorder that impacts nerve cells in the brain and  leads in advanced cases to severe physical debilitation and often dementia and death.

Tillery would not respond to a request for comment, and a Syngenta spokesman also declined to comment.

Also named as defendants in the case are Chevron Phillips Chemical Co., formed as a joint venture between Chevron USA and Phillips 66. Chevron helped distribute Syngenta’s products in the United States. Illinois agricultural cooperative Growmark is also a defendant for its role in supplying paraquat products.

There are currently at least 20 lawsuits filed in multiple state and federal courts across the country on behalf of plaintiffs who have been diagnosed with Parkinson’s and claim Syngenta’s paraquat weed killers are to blame.

The caseload is expected to grow rapidly, and on Thursday the U.S. Judicial Panel on Multidistrict Litigation heard arguments on a motion filed by the Texas-based law firm of Fears Nachawati asking that pending paraquat lawsuits be consolidated for pretrial proceedings in the Northern District of California, the same federal court where Roundup litigation was consolidated.

Additionally, a class action lawsuit was filed in federal court in Iowa on May 3. The suit seeks “equitable relief in the form of medical monitoring, including, but not limited to, the costs of diagnostic testing” for farmers and others exposed to paraquat who are allegedly at “increased risk” for Parkinson’s, according to the legal filing.

Several scientific studies have linked paraquat to Parkinson’s, including a large study of U.S. farmers jointly overseen by multiple U.S. government agencies.

Farmers use paraquat in the production of many crops, including corn, soy and cotton. The Agricultural Health Study (AHS) said it found that “exposure to agricultural pesticides may increase a person’s risk of developing Parkinson’s disease.” In 2011, AHS researchers reported that “participants who used paraquat or rotenone were twice as likely to develop Parkinson’s disease as people who didn’t use these chemicals.”

Syngenta argues that newer and more robust research, including by AHS scientists, has discounted a tie between paraquat and Parkinson’s.

Judge shoots down Bayer’s plan to limit future Roundup legal liability, issues harsh criticism

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(UPDATED May 27 with Bayer statement about new plans)

The federal judge overseeing nationwide Roundup litigation on Wednesday denied Bayer’s latest attempt to limit its legal liability from future cancer claims associated with its glyphosate-based herbicides, citing numerous “glaring flaws” in a settlement proposed to apply to Roundup users who have not yet sued the company but may want to do so in the future.

Saying parts of the plan were “clearly unreasonable” and unfair to cancer sufferers who would be part of the class settlement, U.S. Judge Vince Chhabria castigated Bayer and the small group of lawyers who put the plan together in conjunction with Bayer.

He pointed out that the company has been “losing trials left and right” in claims brought by people suffering from non-Hodgkin lymphoma (NHL) who alleged exposure to Monsanto’s Roundup and other glyphosate-based herbicides were the cause.

Bayer has owned Monsanto since 2018 and has been struggling to defend the cancer claims ever since. Cancer victims have won three trials held to date, and tens of thousands of other plaintiffs have filed lawsuits alleging exposure to Monsanto’s herbicides caused them to develop NHL while Monsanto spent decades hiding the risks.

Elizabeth Cabraser, one of the lawyers who structured the settlement plan, said the proponents were “disappointed” by the ruling and “continue to believe that a multi-billion-dollar class settlement that includes free legal services and substantial compensation to claimants, NHL diagnostic assistance, research into NHL treatment, and Roundup label reform to inform users and the public on all the science regarding a Roundup/NHL link, would provide tremendous financial, health and safety benefits for class members.”

But one of the lead objectors to the plan, lawyer Majed Nachawati, said Cabraser had attempted to “create a sham settlement” that would have harmed the legal rights of “thousands of injured Americans.”

Bayer issued a statement following the judge’s order saying it would consider “the future of glyphosate-based products in the U.S. residential market,” though any changes there would “not affect the availability of glyphosate-based products in markets for professional and agricultural users.” The company said discussions about the future of residential Roundup products was part of a “five-point plan” the company would now pursue.

“The new package of measures, which combine a number of legal and commercial actions, is designed to help the company achieve a level of risk mitigation that is comparable to the previously proposed national class solution,” Bayer said.

Evidence favors plaintiffs, judge says

Judge Chhabria said in his decision that the company’s desire to set up a “science panel” to determine whether or not the herbicides actually cause cancer rather than leave that question to future juries is because of the trial losses the company has so far suffered.

The “reason Monsanto wants a science panel so badly is that the company has lost the ‘battle of the experts’ in three trials, the judge wrote in his order.  “At present, the playing field on the issue of expert testimony related to causation is slanted heavily in favor of plaintiffs.”

The ruling comes after a lengthy hearing last week held to discuss widespread opposition by personal injury attorneys across the United States to the settlement proposal. The proposed plan called for Bayer to put up roughly $2 billion for a series of actions that would help the company avoid future Roundup cancer trials.

The class action settlement would apply to people exposed to Roundup products as of Feb. 3, 2021 who have not yet sued Monsanto or retained a lawyer to do so. The settlement plan would set up a framework for addressing new claims brought by those exposed individuals who develop NHL they attribute to their Roundup exposure. It would apply to people who already have NHL but who have not yet sued the company and to people who develop NHL in the future.

The plan was structured by Bayer in coordination with a small team of plaintiffs’ lawyers who stood to be paid millions of dollars for their participation.

Proponents of the proposed class action plan told the judge it “will save lives,” and provide “speedy compensation” to people who get NHL they blame on Roundup exposure.

But opponents said the proposal actually did little for cancer patients while benefiting Bayer and the lawyers who helped develop the plan.

At the heart of the objections is the view that if approved, the class action plan could limit the due process rights of people to go to trial and seek punitive damages awards in the future if they are diagnosed with NHL after Roundup exposure, while allowing Bayer to keep selling Roundup products with no express warning of a cancer risk on the label.

The limiting of plaintiffs’ ability to seek punitive damages while not limiting Bayer’s ability to keep selling Roundup distinguishes this settlement from any similar class action, according to an opposition brief filed by the nonprofit legal group Public Justice. The plan is a “blueprint for how manufacturers can cut off victims’ rights to seek punitive damages from injuries caused by hazardous pesticides, the group said.

Another key problem with the plan, according to critics, is that everyone in the United States who meets the criteria as a potential plaintiff would automatically become part of the class and subject to its provisions if they did not actively opt out of the class within a specified time period. If people did not opt out – even if they didn’t know about the plan – they would be stripped of  the right to seek punitive damages if they ever did file a lawsuit.

“Monsanto tried to buy its own system of justice and it is wonderful that the court saw through what they were trying to do,” said lawyer Gerson Smoger, who is among the opponents.  “The settlement would’ve been a travesty for those who use Roundup.”

Separate from larger settlement

The class action plan, which is separate from an $11 billion settlement of Roundup litigation announced by Bayer last June to address already filed lawsuits, needs approval from Chhabria. The judge has been overseeing the federal multidistrict Roundup litigation involving thousands of plaintiffs from around the United States.

Bayer’s desire to find a settlement is “not surprising because the alternative to settling – continuing to lose trials left and right – is not attractive,” the judge wrote in his ruling.

“In sum, the settlement proposed by these attorneys would accomplish a lot for Monsanto,” he wrote. “It would substantially diminish the company’s settlement exposure and litigation exposure at the
back end, eliminating punitive damages and potentially increasing its chances of winning trials
on compensatory damages. It would accomplish far less for the Roundup users who have not
been diagnosed with NHL—and not nearly as much as the attorneys pushing this deal contend.”

Bayer’s new plan

Bayer said in addition to consideration of withdrawing Roundup from residential use, the company’s  plan includes the following:

  • Creation and promotion of a new website with scientific studies relevant to Roundup safety, and a request that EPA approves corresponding language on Roundup labels.
  • Exploration of the creation of an independent scientific advisory panel comprised of external scientific experts to review scientific information regarding the safety of Roundup. The results would be released publicly and added to the new website.
  • Continuation of settlement discussions and continuing appeals of the two of the three cases lost at trial. The company already exhausted appeals in the first case it lost at trial. Bayer is hoping to get a case to the U.S. Supreme Court and get a favorable ruling on its position that state-based failure-to-warn claims conflict with, and are preempted by, federal law.

Key Court Hearing Wednesday in Bayer Cancer Liability Litigation

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(UPDATED May 18 with pretrial order)

As Bayer AG works to put an end to costly litigation over alleged connections between Roundup herbicide and cancer, the company faces a critical hearing on Wednesday in federal court in San Francisco.

At issue in the hearing is a proposed $2 billion class action settlement structured by Bayer in coordination with a small team of plaintiffs’ lawyers as a means to address potential future lawsuits.

Proponents of the proposed class action plan say it “will save lives,” and provide “speedy compensation” to people who get NHL.

But the plan has generated widespread opposition from law firms around the country who say the proposal actually does little for cancer patients while benefiting Bayer and the lawyers who structured the proposal and who will be paid millions of dollars in fees if the plan goes through.

The class action settlement would apply to people exposed to Roundup products as of Feb. 3, 2021 who have not yet sued Monsanto or retained a lawyer to do so. The settlement plan would set up a framework for addressing new claims brought by those exposed individuals who develop non-Hodgkin lymphoma (NHL) they attribute to their Roundup exposure.

The class action plan, which is separate from an $11 billion settlement of Roundup litigation announced by Bayer last June to address already filed lawsuits, needs approval from U.S. District Judge Vince Chhabria.  A prior class action settlement plan submitted last year was scorned by Chhabria and then withdrawn. The judge has been overseeing the federal multidistrict Roundup litigation involving thousands of plaintiffs from around the United States.

On Tuesday, Judge Chhabria issued a pretrial order stating that Wednesday’s hearing “will focus on big-picture concerns” with the proposed settlement.

Bayer bought Monsanto in 2018 and has been struggling ever since to defend the line of glyphosate-based herbicide products such as Roundup that Bayer inherited in the acquisition. Cancer victims have won three trials held to date and tens of thousands of other plaintiffs have filed lawsuits alleging exposure to Monsanto’s herbicides caused them to develop non-Hodgkin lymphoma while Monsanto spent decades hiding the risks.

A “Big Prize”

Likening the class action settlement proposal to a “carnival barker hawking a ‘big prize,’” veteran consumer attorney Gerson Smoger told the court in a recent filing: “This is not merely an unfair deal.  It is a deal designed to allow Monsanto to poison future generations. Monsanto knows it can only do this if it can put shackles on our system of justice. After four attempts, it should be clear that this proposed settlement cannot be remedied. This Court should deny preliminary approval and end this exercise in allowing a corporation to buy its own justice system.”

Smoger is one of more than 160 lawyers from more than 90 law firms who have notified the court they object to the proposed class action settlement, which has been rewritten multiple times already to try to appease objections.

At the heart of the objections is the view that if approved, the class action plan could limit the due process rights of people to go to trial and seek punitive damages awards in the future if they are diagnosed with NHL after Roundup exposure, while allowing Bayer to keep selling Roundup products with no express warning of a cancer risk on the label.

The limiting of plaintiffs’ ability to seek punitive damages while not limiting Bayer’s ability to keep selling Roundup distinguishes this settlement from any similar class action, according to an opposition brief filed by the nonprofit legal group Public Justice. The plan is a “blueprint for how manufacturers can cut off victims’ rights to seek punitive damages from injuries caused by hazardous pesticides, the group said.

“Importantly, there has never been a release of punitive damages in a class action settlement involving a hazardous product that was still on the market. If this Court approves this Settlement, it would be the first time that has ever happened in the history of American jurisprudence,” the Public Justice brief states.

The critics also object to the proposed formation of a science panel designed to provide evidence about whether or not the company’s glyphosate-based herbicides actually are carcinogenic, a four-year stay of future litigation, and many other components of the plan.

Proponents Cite Plan Benefits

The legal team pushing the class action settlement forward, counters that the plan actually is a good thing for people who may develop NHL in the future.

“This settlement will save lives. It will deliver notice, outreach, and information, including on the product label itself, to Roundup users—among them those overlooked by the tort system to date—that they may be at risk and should take action,” the proponents of the plan said in a court filing.

According to the class action settlement proponents, the plan will

  • Alert potential class members to be evaluated for NHL, and provide them diagnostic assistance to do so through a medical-monitoring program
  • Provide an option for “significant and speedy compensation” if a class member gets NHL
  • Provide access to free legal services
  • Fund research into treatment and diagnosis of NHL.
  • Allow class members the right to sue Monsanto for compensatory damages if the class member prefers

Judge Chhabria said in an order issued May 10 that along with hearing from the proponents of the plan, he will allow oral arguments from all those who have filed objections to the plan in Wednesday’s hearing.

In his pretrial order issued May 18, Chhabria said several questions would need to be addressed. Among the questions posed by the judge are these:

  • Why is it in the interest of the class to agree in advance to the admission in future trials of
    the conclusions of a court-appointed independent science panel, given how well the trials
    have been going for plaintiffs without such a panel?
  • If the Court understands the settlement correctly, it binds anyone exposed to Roundup
    before February 3, 2021 (assuming they do not opt out), but contemplates that the
    compensation fund and medical monitoring program can be terminated a few years after
    the settlement is approved. Why would it be in the interest of people exposed to Roundup
    before February 2021 to bind themselves to a fund and program that expires so quickly?
  • Is it appropriate to certify a class for settlement purposes when it is obvious that the class could never be certified for litigation purposes?

Another loss for Bayer over Roundup cancer claims as appeals court shoots down preemption argument

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In a blow to Monsanto owner Bayer AG’s bid to block continued liability over Roundup cancer litigation, a federal appeals court shot down the company’s argument that federal regulatory backing of the company’s herbicides preempts claims made by cancer patient Edwin Hardeman.

In a ruling issued Friday, the U.S. Court of Appeals for the Ninth Circuit affirmed the district court’s judgment in favor of Hardeman, and said Monsanto erred in asserting that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts state laws and a duty to warn.

The company’s primary hope since losing all three of three trials held to date is to get a U.S. Supreme Court finding that the U.S. Environmental Protection Agency’s approval of its products under FIFRA  essentially bars complaints that Monsanto didn’t warn of any cancer risk with its herbicides.

The preemption argument is seen as weak by many legal experts because a 2005 U.S. Supreme Court ruling in a case titled Bates v. Dow Agrosciences established that the EPA’s approval of a product does not rule out claims of a failure to warn brought under state law, and FIFRA expressly states that EPA approval doesn’t constitute an absolute defense.

“It’s a dead duck in the water,” Hardeman lawyer Aimee Wagstaff said of the preemption defense. “They need to let that one go.”

Unanimous verdict

Hardeman won a unanimous jury verdict in March 2019 claiming that exposure to Monsanto’s glyphosate-based herbicide products caused his non-Hodgkin lymphoma. He initially was awarded $80 million but the punitive damages were reduced by the trial judge from $75 million to $20 million, leaving him with a total award of approximately $25 million.

The evidence in his case, “showed the carcinogenic risk of glyphosate was knowable at the time of Hardeman’s exposure,” the appeals court ruling states.

The Hardeman case is one of tens of thousands pending against Monsanto for which Bayer is liable after purchasing the company in June of 2018. After Bayer bought Monsanto, four plaintiffs in three trials  won damages against the company. In all, roughly 100,000 U.S. plaintiffs have alleged they developed non-Hodgkin lymphoma after exposure to Monsanto’s glyphosate-based herbicides, such as Roundup. The plaintiffs allege that Monsanto knew for years of scientific evidence showing cancer risks associated with its products, but worked to suppress the information to protect its profits.

In his 2019 ruling cutting the award but upholding the jury finding, U.S. District Judge Vince Chhabria had harsh words for Monsanto, writing: “Despite years of colorable claims in the scientific community that Roundup causes NHL, Monsanto presented minimal evidence suggesting that it was interested in getting to the bottom of those claims… While Monsanto repeatedly intones that it stands by the safety of its product, the evidence at trial painted the picture of a company focused on attacking or undermining the people who raised concerns, to the exclusion of being an objective arbiter of Roundup’s safety.”

Chlorpyrifos: common pesticide tied to brain damage in children

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Chlorpyrifos, a widely used pesticide, is strongly linked to brain damage in children. These and other health concerns have led several countries and some U.S. states to ban chlorpyrifos, but the chemical is still allowed on food crops in the U.S. after successful lobbying by its manufacturer.

Chlorpyrifos in food

Chlorpyrifos insecticides were introduced by Dow Chemical in 1965 and have been used widely in agricultural settings. Commonly known as the active ingredient in the brand names Dursban and Lorsban, chlorpyrifos is an organophosphate insecticide, acaricide and miticide used primarily to control foliage and soil-borne insect pests on a variety of food and feed crops. Products come in liquid form as well as granules, powders, and water-soluble packets, and may be applied by either ground or aerial equipment.

Chlorpyrifos is used on a wide variety of crops including apples, oranges, strawberries, corn, wheat, citrus and other foods families and their children eat daily. USDA’s Pesticide Data Program found chlorpyrifos residue on citrus and melons even after being washed and peeled. By volume, chlorpyrifos is most used on corn and soybeans, with over a million pounds applied annually to each crop. The chemical is not allowed on organic crops.

Non-agricultural uses include golf courses, turf, green houses, and utilities.

Human health concerns

The American Academy of Pediatrics, which represents more than 66,000 pediatricians and pediatric surgeons, has warned that continued use of chlorpyrifos puts developing fetuses, infants, children and pregnant women at great risk.

Scientists have found that prenatal exposures to chlorpyrifos are associated with lower birth weight, reduced IQ, the loss of working memory, attention disorders, and delayed motor development. Key studies are listed below.

See these comments to regulators from the Endocrine Society citing “ample evidence that chlorpyrifos has extensive effects on neurological and endocrine systems with demonstrated evidence of harm to humans and wildlife.”

Chlorpyrifos is also linked to acute pesticide poisoning and can cause convulsions, respiratory paralysis, and sometimes, death.

FDA says food and drinking water exposures unsafe

Chlorpyrifos is so toxic that the European Food Safety Authority banned sales of the chemical as of January 2020, finding that there is no safe exposure level. Some U.S. states have also banned chlorpyrifos from farming use, including California and Hawaii.

The U.S. Environmental Protection Agency (EPA) reached agreement with Dow Chemical in 2000 to phase out all residential uses of chlorpyrifos because of scientific research showing the chemical is dangerous to the developing brains of babies and young children. It was banned from use around schools in 2012.

In October 2015, the EPA said it planned to revoke all food residue tolerances for chlorpyrifos, meaning it would no longer be legal to use it in agriculture. The agency said “expected residues of chlorpyrifos on food crops exceed the safety standard under the Federal Food, Drug, and Cosmetic Act.” The move came in response to a petition for a ban from the Natural Resources Defense Council and Pesticide Action Network.

In November 2016, the EPA released a revised human health risk assessment for chlorpyrifos confirming it was unsafe to allow the chemical to continue in use in agriculture.  Among other things, the EPA said all food and drinking water exposures were unsafe, especially to children 1-2 years old. The EPA said the ban would take place in 2017.

Trump EPA delays ban

Following the election of Donald Trump as President of the United States, the proposed chlorpyrifos ban was delayed. In March 2017, in one of his first formal actions as the nation’s top environmental official, EPA Administrator Scott Pruitt rejected the petition by environmental groups and said the ban on chlorpyrifos would not go forward.

The Associated Press reported in June 2017 that Pruitt had met with Dow CEO Andrew Liveris 20 days before halting the ban. Media also reported that Dow contributed $1 million to Trump’s inaugural activities.

In February of 2018, EPA reached a settlement requiring Syngenta to pay a $150,000 fine and train farmers in pesticide use after the company failed to warn workers to avoid fields where chlorpyrifos was recently sprayed and several workers who entered the fields were sickened and required medical care. The Obama EPA had initially proposed a fine nearly nine times larger.

In February 2020, after pressure from consumer, medical, scientific groups and in face of growing calls for bans around the world, Corteva AgriScience (formerly DowDuPont) said it would phase out production of chlorpyrifos, but the chemical remains legal for other companies to make and sell.

According to an analysis published in July 2020, U.S. regulators relied on falsified data provided by Dow Chemical to allow unsafe levels of chlorpyrifos into American homes for years. The analysis from University of Washington researchers said the inaccurate findings were the result of a chlorpyrifos dosing study done in the early 1970s for Dow.

In September 2020 the EPA issued its third risk assessment on chlorpyrifos, saying “despite several years of study, peer review, and public process, the science addressing neurodevelopmental effects remains unresolved,” and it still could be used in food production.

The decision came after multiple meetings between the EPA and Corteva.

Groups and states sue EPA

Following the Trump administration’s decision to delay any ban until at least 2022, Pesticide Action Network and Natural Resources Defense Council filed suit against the EPA in April 2017, seeking to force the government to follow through with the Obama administration’s recommendations to ban chlorpyrifos. In August 2018, a federal appeals court found that the EPA broke the law by continuing to allow use of chlorpyrifos, and ordered EPA to finalize its proposed ban within two months. After more delays, EPA Administrator Andrew Wheeler announced in July 2019 that EPA would not ban the chemical.

Several states have sued the EPA over its failure to ban chlorpyrifos, including California, New York, Massachusetts, Washington, Maryland, Vermont and Oregon. The states argue in court documents that chlorpyrifos should be banned in food production due to the dangers associated with it.

Earthjustice has also filed a lawsuit in the U.S. Court of Appeals for the Ninth Circuit Court seeking a nationwide ban on behalf of groups advocating for environmentalists, farmworkers and people with learning disabilities.

On April 29, 2021, the U.S. Judge Jed S. Rakoff  of the Ninth Circuit issued a decision, finding the EPA had engaged in an “egregious delay” that exposed a generation of American children to unsafe levels of chlorpyrifos.”  He ordered the EPA to issue a final regulation within 60 days that modifies or revokes the registration for chlorpyrifos.

Medical and scientific studies

Developmental neurotoxicity

“The epidemiological studies reviewed herein have reported statistically significant correlations between prenatal exposures to CPF [chlorpyrifos] and postnatal neurological complications, particularly cognitive deficits that are also associated with disruption of the structural integrity of the brain…. Various preclinical research groups throughout the world have consistently demonstrated that CPF is a developmental neurotoxicant. The developmental CPF neurotoxicity, which is well supported by studies using different animal models, routes of exposure, vehicles, and testing methods, is generally characterized by cognitive deficits and disruption of the structural integrity of the brain.” Developmental neurotoxicity of the organophosphorus insecticide chlorpyrifos: from clinical findings to preclinical models and potential mechanisms. Journal of Neurochemistry, 2017.

“Since 2006, epidemiological studies have documented six additional developmental neurotoxicants—manganese, fluoride, chlorpyrifos, dichlorodiphenyltrichloroethane, tetrachloroethylene, and the polybrominated diphenyl ethers.” Neurobehavioural effects of developmental toxicity. Lancet Neurology, 2014.

Childrens’ IQ & cognitive development

Longitudinal birth cohort study of inner-city mothers and children found that “higher prenatal CPF [chlorpyrifos] exposure, as measured in umbilical cord blood plasma, was associated with decreases in cognitive functioning on two different WISC-IV indices, in a sample of urban minority children at 7 years of age…the Working Memory Index was the most strongly associated with CPF exposure in this population.” Seven-Year Neurodevelopmental Scores and Prenatal Exposure to Chlorpyrifos, a Common Agricultural Pesticide. Environmental Health Perspectives, 2011.

Birth cohort study of predominantly Latino farmworker families in California associated a metabolite of organophosphate pesticides found in the urine in pregnant women with poorer scores in their children for memory, processing speed, verbal comprehension, perceptual reasoning and IQ.  “Our findings suggest that prenatal exposure to OP [organophosphate] pesticides, as measured by urinary DAP [dialkyl phosphate] metabolites in women during pregnancy, is associated with poorer cognitive abilities in children at 7 years of age. Children in the highest quintile of maternal DAP concentrations had an average deficit of 7.0 IQ points compared with those in the lowest quintile. Associations were linear, and we observed no threshold.” Prenatal Exposure to Organophosphate Pesticides and IQ in 7-Year-Old Children. Environmental Health Perspectives, 2011.

Prospective cohort study of women and their children findings “suggest that prenatal exposure to organophosphates is negatively associated with cognitive development, particularly perceptual reasoning, with evidence of effects beginning at 12 months and continuing through early childhood.” Prenatal Exposure to Organophosphates, Paraoxonase 1, and Cognitive Development in Childhood. Environmental Health Perspectives, 2011.

Prospective cohort study of an inner-city population found that children with high levels of exposure to chlorpyrifos “scored, on average, 6.5 points lower on the Bayley Psychomotor Development Index and 3.3 points lower on the Bayley Mental Development Index at 3 years of age compared with those with lower levels of exposure. Children exposed to higher, compared with lower, chlorpyrifos levels were also significantly more likely to experience Psychomotor Development Index and Mental Development Index delays, attention problems, attention-deficit/hyperactivity disorder problems, and pervasive developmental disorder problems at 3 years of age.” Impact of Prenatal Chlorpyrifos Exposure on Neurodevelopment in the First 3 Years of Life Among Inner-City Children. Journal of the American Academy of Pediatrics, 2006.

Longitudinal birth cohort study in an agricultural region of California extends “previous findings of associations between PON1 genotype and enzyme levels and certain domains of neurodevelopment through early school age, presenting new evidence that adverse associations between DAP [dialkyl phosphate]levels and IQ may be strongest in children of mothers with the lowest levels of PON1 enzyme.” Organophosphate pesticide exposure, PON1, and neurodevelopment in school-age children from the CHAMACOS study.  Environmental Research, 2014.

Autism and other neurodevelopmental disorders

Population based case-control study found that, “Prenatal or infant exposure to a priori selected pesticides—including glyphosate, chlorpyrifos, diazinon, and permethrin—were associated with increased odds of developing autism spectrum disorder.” Prenatal and infant exposure to ambient pesticides and autism spectrum disorder in children: population based case-control study. BMJ, 2019.

Population-based case-control study “observed positive associations between ASD [autism spectrum disorders] and prenatal residential proximity to organophosphate pesticides in the second (for chlorpyrifos) and third trimesters (organophosphates overall)”. Neurodevelopmental Disorders and Prenatal Residential Proximity to Agricultural Pesticides: The CHARGE Study. Environmental Health Perspectives, 2014.

See also: Tipping the Balance of Autism Risk: Potential Mechanisms Linking Pesticides and Autism. Environmental Health Perspectives, 2012.

Brain anomalies

“Our findings indicate that prenatal CPF [chlorpyrifos] exposure, at levels observed with routine (nonoccupational) use and below the threshold for any signs of acute exposure, has a measureable effect on brain structure in a sample of 40 children 5.9–11.2 y of age. We found significant abnormalities in morphological measures of the cerebral surface associated with higher prenatal CPF exposure….Regional enlargements of the cerebral surface predominated and were located in the superior temporal, posterior middle temporal, and inferior postcentral gyri bilaterally, and in the superior frontal gyrus, gyrus rectus, cuneus, and precuneus along the mesial wall of the right hemisphere”. Brain anomalies in children exposed prenatally to a common organophosphate pesticide.  Proceedings of the National Academy of Sciences, 2012.

Fetal growth

This study “saw a highly significant inverse association between umbilical cord chlorpyrifos levels and both birth weight and birth length among infants in the current cohort born prior to U.S. EPA regulatory actions to phase out residential uses of the insecticide.” Biomarkers in assessing residential insecticide exposures during pregnancy and effects on fetal growth. Toxicology and Applied Pharmacology, 2005.

Prospective, multiethnic cohort study found that “when the level of maternal PON1 activity was taken into account, maternal levels of chlorpyrifos above the limit of detection coupled with low maternal PON1 activity were associated with a significant but small reduction in head circumference. In addition, maternal PON1 levels alone, but not PON1 genetic polymorphisms, were associated with reduced head size. Because small head size has been found to be predictive of subsequent cognitive ability, these data suggest that chlorpyrifos may have a detrimental effect on fetal neurodevelopment among mothers who exhibit low PON1 activity.” In Utero Pesticide Exposure, Maternal Paraoxonase Activity, and Head Circumference.  Environmental Health Perspectives, 2003.

Prospective cohort study of minority mothers and their newborns “confirm our earlier findings of an inverse association between chlorpyrifos levels in umbilical cord plasma and birth weight and length…Further, a dose-response relationship was additionally seen in the present study. Specifically, the association between cord plasma chlorpyrifos and reduced birth weight and length was found principally among newborns with the highest 25% of exposure levels.” Prenatal Insecticide Exposures and Birth Weight and Length among an Urban Minority Cohort. Environmental Health Perspectives, 2004.

Lung Cancer  

In an evaluation of over 54,000 pesticide applicators in the Agricultural Health Study, scientists at the National Cancer Institute reported that the incidence of lung cancer was associated with chlorpyrifos exposure. “In this analysis of cancer incidence among chlorpyrifos-exposed licensed pesticide applicators in North Carolina and Iowa, we found a statistically significant trend of increasing risk of lung cancer, but not of any other cancer examined, with increasing chlorpyrifos exposure.” Cancer Incidence Among Pesticide Applicators Exposed to Chlorpyrifos in the Agricultural Health Study. Journal of the National Cancer Institute, 2004.

Parkinson’s Disease

Case-control study of people living in California’s Central Valley reported that ambient exposure to 36 commonly used organophosphate pesticides separately increased the risk of developing Parkinson’s disease. The study “adds strong evidence” that organophosphate pesticides are “implicated” in the etiology of idiopathic Parkinson’s disease. The association between ambient exposure to organophosphates and Parkinson’s disease risk. Occupational & Environmental Medicine, 2014.

Birth outcomes

Multiethnic parent cohort of pregnant women and newborns found that chlorpyrifos “was associated with decreased birth weight and birth length overall (p = 0.01 and p = 0.003, respectively) and with lower birth weight among African Americans (p = 0.04) and reduced birth length in Dominicans (p < 0.001)”. Effects of Transplacental Exposure to Environmental Pollutants on Birth Outcomes in a Multiethnic Population. Environmental Health Perspectives, 2003.

Neuroendocrine disruption

“Through the analysis of complex sex-dimorphic behavioral patterns we show that neurotoxic and endocrine disrupting activities of CPF [chlorpyrifos] overlap. This widely diffused organophosphorus pesticide might thus be considered as a neuroendocrine disruptor possibly representing a risk factor for sex-biased neurodevelopmental disorders in children.” Sex dimorphic behaviors as markers of neuroendocrine disruption by environmental chemicals: The case of chlorpyrifos. NeuroToxicology, 2012.

Tremor

“The present findings show that children with high prenatal exposure to chlorpyrifos were significantly more likely to show mild or mild to moderate tremor in one or both arms when assessed between the ages of 9 and 13.9 years of age….Taken together, growing evidence suggests that prenatal exposure to CPF [chlorpyrifos], at current standard usage levels, is associated with a range of persistent and inter-related developmental problems.” Prenatal exposure to the organophosphate pesticide chlorpyrifos and childhood tremor. NeuroToxicology, 2015.

Cost of chlorpyrifos

Cost estimates of exposure to endocrine-disrupting chemicals in the European Union found that “Organophosphate exposures were associated with 13.0 million (sensitivity analysis, 4.24 million to 17.1 million) lost IQ points and 59 300 (sensitivity analysis, 16 500 to 84 400) cases of intellectual disability, at costs of €146 billion (sensitivity analysis, €46.8 billion to €194 billion).” Neurobehavioral Deficits, Diseases, and Associated Costs of Exposure to Endocrine-Disrupting Chemicals in the European Union. Journal of Clinical Endocrinology & Metabolism, 2015.

Thyroid in mice

“The present study showed that exposure of CD1 mice, during critical windows of prenatal and postnatal development, at CPF [chlorpyrifos] dose levels below those inhibiting brain AchE, can induce alterations in thyroid.” Developmental Exposure to Chlorpyrifos Induces Alterations in Thyroid and Thyroid Hormone Levels Without Other Toxicity Signs in Cd1 Mice.  Toxicological Sciences, 2009.

Problems with industry studies

“In March 1972, Frederick Coulston and colleagues at the Albany Medical College reported results of an intentional chlorpyrifos dosing study to the study’s sponsor, Dow Chemical Company. Their report concluded that 0.03 mg/kg-day was the chronic no-observed-adverse-effect-level (NOAEL) for chlorpyrifos in humans. We demonstrate here that a proper analysis by the original statistical method should have found a lower NOAEL (0.014 mg/kg-day), and that use of statistical methods first available in 1982 would have shown that even the lowest dose in the study had a significant treatment effect. The original analysis, conducted by Dow-employed statisticians, did not undergo formal peer review; nevertheless, EPA cited the Coulston study as credible research and kept its reported NOAEL as a point of departure for risk assessments throughout much of the 1980′s and 1990′s. During that period, EPA allowed chlorpyrifos to be registered for multiple residential uses that were later cancelled to reduce potential health impacts to children and infants. Had appropriate analyses been employed in the evaluation of this study, it is likely that many of those registered uses of chlorpyrifos would not have been authorized by EPA. This work demonstrates that reliance by pesticide regulators on research results that have not been properly peer-reviewed may needlessly endanger the public.” Flawed analysis of an intentional human dosing study and its impact on chlorpyrifos risk assessments. Environment International, 2020.

“In our review of raw data on a prominent pesticide, chlorpyrifos, and a related compound, discrepancies were discovered between the actual observations and the conclusions drawn by the test laboratory in the report submitted for authorization of the pesticide.” Safety of Safety Evaluation of Pesticides: developmental neurotoxicity of chlorpyrifos and chlorpyrifos-methyl. Environmental Health, 2018.

Other fact sheets

Harvard Kennedy School Shorenstein Center: A controversial insecticide and its effect on brain development: Research and resources

Harvard University: The Most Widely Used Pesticide, One Year Later

Earthjustice: Chlorpyrifos: The toxic pesticide harming our children and environment

Sierra Club: Kids and Chlorpyrifos

Journalism and Opinion

Imaging by Bradley Peterson, via Proceedings of the National Academy of Sciences; New York Times

Court Rules that EPA’s Delay “Exposed a Generation of American Children” to Brain-Damaging Pesticide Chlorpyrifos , by Sharon Lerner, The Intercept. “After 14 years of legal battles, a federal court ordered the Environmental Protection Agency to take actions that will likely force the neurotoxic pesticide chlorpyrifos off the market. The federal agency has for years been considering mounting evidence that links the pesticide to brain damage in children — including loss of IQ, learning difficulties, ADHD, and autism — but, as the court acknowledged, has repeatedly delayed taking action.”

Trump’s Legacy: Damaged Brains, by Nicholas Kristof, New York Times. “The pesticide, which belongs to a class of chemicals developed as a nerve gas made by Nazi Germany, is now found in food, air and drinking water. Human and animal studies show that it damages the brain and reduces I.Q.s while causing tremors among children.”

Protect Our Children’s Brains, by Sharon Lerner, New York Times. “The widespread use of chlorpyrifos does point to the fact that it’s not the kind of chemical that harms everyone who comes in contact with it — or causes them to drop dead on impact. Instead, the research shows increases in the risk of suffering from certain developmental problems that, while less dramatic, are also, alarmingly, enduring.”

Poison Fruit: Dow Chemical Wants Farmers to Keep Using a Pesticide Linked to Autism and ADHD, by Sharon Lerner, The Intercept. “Dow, the giant chemical company that patented chlorpyrifos and still makes most of the products containing it, has consistently disputed the mounting scientific evidence that its blockbuster chemical harms children. But the government report made it clear that the EPA now accepts the independent science showing that the pesticide used to grow so much of our food is unsafe.”

When enough data are not enough to enact policy: The failure to ban chlorpyrifos, by Leonardo Trasande, PLOS Biology. “Scientists have a responsibility to speak up when policymakers fail to accept scientific data. They need to emphatically declare the implications of policy failures, even if some of the scientific underpinnings remain uncertain.”

How Has This Pesticide Not Been Banned? by the editorial board of The New York Times. “The pesticide known as chlorpyrifos is both clearly dangerous and in very wide use. It is known to pass easily from mother to fetus and has been linked to a wide range of serious medical problems, including impaired development, Parkinson’s disease and some forms of cancer. That’s not entirely surprising. The chemical was originally developed by Nazis during World War II for use as a nerve gas. Here’s what is surprising: Tons of the pesticide are still being sprayed across millions of acres of United States farmland every year, nearly five years after the Environmental Protection Agency determined that it should be banned.”

This pesticide is closely related to nerve agents used in World War II. Trump’s EPA doesn’t care, by Joseph G. Allen, Washington Post. “What we know about chlorpyrifos is alarming. Perhaps the most well-known study is one done by researchers at Columbia University who performed brain imaging on young kids with high exposure to chlorpyrifos. The results are shocking and unambiguous. In the words of the researchers: “This study reports significant associations of prenatal exposure to a widely used environmental neurotoxicant, at standard use levels, with structural changes in the developing human brain.”

A Strong Case Against a Pesticide Does Not Faze E.P.A. Under Trump, by Roni Caryn Robin, New York Times. “An updated human health risk assessment compiled by the E.P.A. in November found that health problems were occurring at lower levels of exposure than had previously been believed harmful. Infants, children, young girls and women are exposed to dangerous levels of chlorpyrifos through diet alone, the agency said. Children are exposed to levels up to 140 times the safety limit.”

Babies Are Larger After Ban On 2 Pesticides, Study Finds, by Richard Pérez-Peña, New York Times. “Pregnant women in upper Manhattan who were heavily exposed to two common insecticides had smaller babies than their neighbors, but recent restrictions on the two substances quickly lowered exposure and increased babies’ size, according to a study being published today.”

Poisons Are Us, by Timothy Egan, New York Times. “When you bite into a piece of fruit, it should be a mindless pleasure. Sure, that steroidal-looking strawberry with a toothpaste-white interior doesn’t seem right to begin with. But you shouldn’t have to think about childhood brain development when layering it over your cereal. The Trump administration, in putting chemical industry toadies between our food and public safety, has forced a fresh appraisal of breakfast and other routines that are not supposed to be frightful.”

On your dinner plate and in your body: The most dangerous pesticide you’ve never heard of, by Staffan Dahllöf, Investigative Reporting Denmark. “The poisonous effect of chlorpyrifos on insects is not disputed. The unresolved question is to what extent the usage of chlorpyrifos is dangerous to all living organisms like fish in nearby waters or farm workers in the fields, or to anybody eating the treated products.”

Neurotoxins on your kid’s broccoli: that’s life under Trump, by Carey Gillam, The Guardian. “How much is your child’s health worth? The answer coming from the leadership of the US Environmental Protection Agency is: not that much… So here we are – with scientific concerns for the safety of our innocent and vulnerable children on one side and powerful, wealthy corporate players on the other. Our political and regulatory leaders have shown whose interests they value most.”

Common Insecticide May Harm Boys’ Brains More Than Girls, by Brett Israel, Environmental Health News. “In boys, exposure to chlorpyrifos in the womb was associated with lower scores on short-term memory tests compared with girls exposed to similar amounts.“

More science fact sheets on chemicals in our food 

Find more U.S. Right to Know fact sheets:

Aspartame: Decades of Science Point to Serious Health Risks

Glyphosate Fact Sheet: Cancer and Other Health Concerns

Dicamba Fact Sheet 

U.S. Right to Know is an investigative public health group working globally to expose corporate wrongdoing and government failures that threaten the integrity of our food system, our environment and our health.  You can donate here to our investigations and sign up for our weekly newsletter.  

Trial pitting farmers against Syngenta delayed until June

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A highly anticipated first-ever trial pitting a group of farmers against the global agricultural giant Syngenta AG over allegations that Syngenta’s paraquat weed killer causes Parkinson’s disease has been delayed until June, the parties involved said on Saturday.

The trial was set to begin Monday, livestreamed by Courtroom View Network, but a continuance was ordered setting a new trial date for June 1. A spokesman for the plaintiffs’ legal team said the delay was not due to any settlement efforts, but due to “a combination of scheduling and Covid issues.”

The case is titled Hoffman V. Syngenta and is set for a bench trial in St. Clair County Circuit Court in Illinois before Associate Judge Kevin Hoerner.

The plaintiffs are farmers who developed Parkinson’s after repeated exposure to paraquat products, specifically Syngenta’s widely used Gramoxone brand, and the spouses of those farmers. Three of the original plaintiffs in the case have died, including plaintiff Thomas Hoffman.

Parkinson’s is a disorder that impacts nerve cells in the brain and  leads in advanced cases to severe physical debilitation and often dementia and death.

Experts in the study and treatment of Parkinson’s warn that the disease is on the rise. One such expert, Dutch neurologist Bastiaan Bloem, predicts the number of people suffering from Parkinson’s will double to more than 13 million in the next 20 years.

Bloem is one of many scientists who blame exposure to paraquat as among multiple risk factors for developing Parkinson’s.

Also named as defendants in the case are Chevron Phillips Chemical Co., formed as a joint venture between Chevron USA and Phillips 66. Chevron helped distribute Syngenta’s products in the United States. Illinois agricultural cooperative Growmark is also a defendant for its role in supplying paraquat products.

There are currently at least 20 lawsuits filed in multiple state and federal courts across the country on behalf of plaintiffs who have been diagnosed with Parkinson’s, and claim Syngenta’s paraquat weed killers are to blame.

Lawyer C. Calvin Warriner III, who is not involved in the Hoffman case but has other plaintiffs suing over the same issues, said he predicts “hundreds if not thousands of cases” will be filed in the next year because of “solid” scientific evidence linking paraquat to Parkinson’s.