A death and a settlement as Bayer continues trying to end Roundup litigation

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Seven months after Bayer AG announced plans for a sweeping settlement of U.S. Roundup cancer litigation, the German owner of Monsanto Co. continues to work to settle tens of thousands of claims brought by people suffering from cancer they say was caused by Monsanto’s weed killing products. On Wednesday, one more case appeared to find closure, though the plaintiff did not live to see it.

Lawyers for Jaime Alvarez Calderon, agreed earlier this week to a settlement offered by Bayer after U.S. District Judge Vince Chhabria on Monday denied summary judgment in favor of Monsanto, allowing the case to move closer to a trial.

The settlement will go to Alvarez’s four sons because their 65-year-old father, a longtime winery worker in Napa County, California, died just over a year ago from non-Hodgkin lymphoma he blamed on his work spraying Roundup around winery property for years.

In a hearing held in federal court Wednesday, Alvarez family lawyer David Diamond told Judge Chhabria that the settlement would close out the case.

After the hearing, Diamond said Alvarez had worked in the wineries for 33 years, using a backpack sprayer to apply Monsanto’s glyphosate-based herbicides to sprawling acreage for the Sutter Home group of wineries. He would often go home in the evenings with clothing wet with herbicide due to leaks in the equipment and weed killer that drifted in the wind.  He was diagnosed in 2014 with non-Hodgkin lymphoma, undergoing multiple rounds of chemotherapy and other treatments before dying in December 2019.

Diamond said he was happy to settle the case but has “400 plus” more Roundup cases still unresolved.

He is not alone. At least half a dozen other U.S. law firms have Roundup plaintiffs they are seeking trial settings for in 2021 and beyond.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides do cause cancer and that Monsanto spent decades hiding the risks.

In addition to efforts to resolve claims currently pending, Bayer also hopes to create a mechanism for resolving potential claims that it could face from Roundup users who develop non-Hodgkin lymphoma in the future. Its initial plan for handling future litigation was rejected by Judge Chhabria and the company has yet to announce a new plan.

Bayer’s bid to settle U.S. Roundup cancer claims making progress

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Monsanto owner Bayer AG is making progress toward a sweeping settlement of thousands of U.S. lawsuits brought by people alleging they or their loved ones developed cancer after exposure to Monsanto’s Roundup herbicides.

Recent correspondence from plaintiffs’ lawyers to their clients underscored that progress, confirming a large percentage of plaintiffs are opting to participate in the settlement, despite complaints by many plaintiffs that they are facing unfairly small payout proposals.

By some calculations, the average gross settlement will leave little to no compensation, perhaps a few thousand dollars, for individual plaintiffs after attorneys’ fees are paid and certain insured medical costs are reimbursed.

Nevertheless, according to a letter sent to plaintiffs in late November by one of the lead law firms in the litigation, more than 95 percent of the “eligible claimants” decided to participate in the settlement plan negotiated by the firm with Bayer. A “settlement administrator” now has 30 days to review the cases and confirm the plaintiffs’ eligibility to receive settlement funds, according to the correspondence.

People can choose to opt out of the settlement and take their claims to mediation, followed by binding arbitration if they wish or try to find a new lawyer who would take their case to trial. Those plaintiffs could have a difficult time finding a lawyer to help them take their case to trial because the law firms agreeing to the settlements with Bayer have agreed not to try any more cases or assist in future trials.

One plaintiff, who asked not to be identified by name due to the confidentiality of the settlement proceedings, said he is opting out of the settlement in hopes of obtaining more money through mediation or a future trial. He said he requires ongoing tests and treatments for his cancer and the proposed settlement structure would leave him nothing to cover those ongoing costs.

“Bayer wants a release by paying as little as possible without going to trial,” he said.

The rough estimate on average gross payouts per plaintiff is about $165,000, lawyers and plaintiffs involved in the discussions have said.  But some plaintiffs could receive far more, and some less, depending upon the details of their case. There are many criteria determining who can participate in the settlement and how much money that person may receive.

To be eligible, the Roundup user has to be a U.S. citizen, have been diagnosed with non-Hodgkin lymphoma (NHL), and had exposures to Roundup for at least one year prior to being diagnosed with NHL.

The settlement agreement with Bayer will be complete when the administrator confirms that more than 93 percent of claimants qualify, according to the terms of the deal.

If the settlement administrator finds a plaintiff ineligible, that plaintiff has 30 days to appeal the decision.

For plaintiffs deemed eligible the settlement administrator will award each case a number of points based on specific criteria. The amount of money each plaintiff will receive is based on the number of points calculated for their individual situation.

Basis points are established using the age of the individual at the time they were diagnosed with NHL and the level of severity of the “injury” as determined by the degree of treatment and outcome. The levels run 1-5. Someone who died from NHL is assigned basis points for a level 5, for instance. More points are given to younger people who suffered multiple rounds of treatment and/or died.

In addition to the basis points, adjustments are allowed that give more points to plaintiffs who had more exposure to Roundup. There are also allowances for more points for specific types of NHL. Plaintiffs diagnosed with a type of NHL called Primary Central Nervous System (CNS) lymphoma receive a 10 percent boost to their points tally, for example.

People can also have points deducted based on certain factors. Here are a few specific examples from the points matrix established for the Roundup litigation:

  • If a Roundup product user died before January 1, 2009, the total points for the claim brought on their behalf will be reduced by 50 percent.
  • If a deceased plaintiff had no spouse or minor children at the time of their death there is a deduction of 20 percent.
  • If a plaintiff had any prior blood cancers before using Roundup their points are cut by 30 percent.
  • If the span of time between a claimant’s Roundup exposure and the diagnosis of NHL was less than two years the points are cut 20 percent.

The settlement funds should begin to flow to participants in the spring with final payments hopefully made by summer, according to lawyers involved.

Plaintiffs can also apply to be part of an “extraordinary injury fund,” set up for a small group of plaintiffs who suffer from severe NHL-related injuries. A claim may be eligible for the extraordinary injury fund if the individual’s death from NHL came after three or more full courses of chemotherapy and other aggressive treatments.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides, such as Roundup, do cause cancer and that Monsanto spent decades hiding the risks.

The jury awards totaled well over $2 billion, though the judgments have been ordered reduced by trial and appellate court judges.

The company’s efforts to resolve the litigation have been stymied in part by the challenge of how to head off claims that could be brought in the future by people who develop cancer after using the company’s herbicides.

Trial Appeals Continue

Even as Bayer aims to head off future trials with settlement dollars, the company continues to try to overturn the outcomes of the three trials the company lost.

In the first trial loss – the Johnson v. Monsanto case – Bayer lost efforts to overturn the jury finding that Monsanto was liable for Johnson’s cancer at the appellate court level, and in October, the California Supreme Court refused to review the case.

Bayer now has 150 days from that decision to ask for the matter to be taken up by the U.S. Supreme Court. The company has not made a final decision regarding that move, according to a Bayer spokesman, but has indicated previously that it does intend to take such action.

If Bayer does petition the U.S. Supreme Court, Johnson’s attorneys are expected to file a conditional cross-appeal asking the court to examine the judicial actions that slashed Johnson’s jury award from $289 million to $20.5 million.

Other Bayer/Monsanto court cases

In addition to the liability Bayer faces from Monsanto’s Roundup cancer litigation, the company is struggling with Monsanto liabilities in PCB pollution litigation and in litigation over crop damage caused by Monsanto’s dicamba herbicide-based crop system.

A federal judge in Los Angeles last week rejected a proposal by Bayer to pay $648 million to settle class-action litigation brought by claimants alleging contamination from polychlorinated biphenyls, or PCBs, made by the Monsanto.

Also last week, the trial judge in the case of Bader Farms, Inc. v. Monsanto rejected Bayer’s motions for a new trial.  The judge cut the punitive damages awarded by the jury, however, from $250 million to $60 million, leaving intact compensatory damages of $15 million, for a total award of $75 million.

Documents obtained through discovery in the Bader case revealed that Monsanto and chemical giant BASF were aware for years that their plans to introduce a dicamba herbicide-based agricultural seed and chemical system would probably lead to damage on many US farms.

New glyphosate papers point to “urgency” for more research on chemical impact to human health

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Newly published scientific papers illustrate the ubiquitous nature of the weed killing chemical glyphosate and a need to better understand the impact exposure to the popular pesticide may be having on human health, including the health of the gut microbiome.

In one of the new papers, researchers from the University of Turku in Finland said that they were able to determine, in a “conservative estimate,” that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. The researchers said they used a new bioinformatics method to make the finding.

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, which was published this month in the Journal of Hazardous Materials.

The microbes in the human gut include a variety of bacteria and fungi and are believed to impact immune functions and other important processes. Unhealthy gut microbiomes are believed by some scientists to contribute to a range of diseases.

“Although data on glyphosate residues in human gut systems are still lacking, our results suggest that glyphosate residues decrease bacterial diversity and modulate bacterial species composition in the gut,” the authors said. “We may assume that long-term exposure to glyphosate residues leads to the dominance of resistant strains in the bacterial community.”

The concerns about glyphosate’s impact on the human gut microbiome stem from the fact that glyphosate works by targeting an enzyme known as 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS.) This enzyme is critical to the synthesizing of essential amino acids.

“To determine the actual impact of glyphosate on the human gut microbiota and other organisms, further empirical studies are needed to reveal glyphosate residues in food, to determine the effects of pure glyphosate and commercial formulations on microbiomes and to assess the extent to which our EPSPS amino acid markers predict bacterial susceptibility to glyphosate in in vitro and real-world scenarios,” the authors of the new paper concluded.

In addition to the six researchers from Finland, one of the authors of the paper is affiliated with the department of biochemistry and biotechnology at Rovira i Virgili University, Tarragona, Catalonia, in Spain.

“The consequences for human health are not determined in our study. However, based on previous studies… we know that alterations in the human gut microbiome may be connected to several diseases,” University of Turku researcher Pere Puigbo said in an interview.

“I hope that our research study opens the door to further experiments, in-vitro and in the field, as well as population-based studies to quantify the effect the use of glyphosate has on human populations and other organisms,” Puigbo said.

Introduced in 1974

Glyphosate is the active ingredient in Roundup herbicides and hundreds of other weed killing products sold around the world. It was introduced as a weed killer by Monsanto in 1974 and grew to become the most widely used herbicide after Monsanto’s introduction in the 1990s of crops genetically engineered to tolerate the chemical. Residues of glyphosate are commonly found on food and in water. Consequently, residues are also often detected in the urine of people exposed to glyphosate through either diet and/or application.

U.S. regulators and Monsanto owner Bayer AG maintain there are no human health concerns with glyphosate exposure when the products are used as intended, including from residues in the diet.

The body of research contradicting those claims is growing, however. The research on the potential impacts of glyphosate on the gut microbiome is not nearly as robust as the literature associating glyphosate to cancer, but is an area many scientists are probing.

In a somewhat related paper published this month, a team of researchers from Washington State University and Duke University said that they had found a correlation between the levels of bacteria and fungi in the gastrointestinal tracts of children and the chemicals found in their homes. The researchers did not look at glyphosate specifically, but were alarmed to find that children with higher levels of common household chemicals in their bloodstream showed a reduction in the amount and diversity of important bacteria in their gut.

Glyphosate in urine

An additional scientific paper published this month underscored a need for better and more data when it comes to glyphosate exposure and children.

The paper, published in the journal Environmental Health by researchers from the Institute for Translational Epidemiology at the Icahn School of Medicine at Mount Sinai in New York, is the outcome of a literature review of multiple studies reporting actual values of glyphosate in people.

The authors said they analyzed five studies published in the last two years reporting glyphosate levels measured in people, including one study in which urinary glyphosate levels were measured in children living in rural Mexico. Of 192 children living in the Agua Caliente area, 72.91 percent had detectable levels of glyphosate in their urine, and all of the 89 children living in Ahuacapán, Mexico, had detectable levels of the pesticide in their urine.

Even when including additional studies, overall, there is sparse data regarding glyphosate levels in people. Studies globally total only 4,299 people, including 520 children, the researchers said.

The authors concluded that it is not currently possible to understand the “potential relationship” between glyphosate exposure and disease, especially in children, because data collection on exposure levels in people is limited and not standardized.

They noted that despite the lack of solid data about the impacts of glyphosate on children, the amount of glyphosate residues legally allowed by U.S. regulators on food has increased dramatically over the years.

“There are gaps in the literature on glyphosate, and these gaps should be filled with some urgency, given the large use of this product and its ubiquitous presence,” said author Emanuela Taioli.

Children are especially vulnerable to environmental carcinogens and tracking exposure to products such as glyphosate in children is “a pressing public health priority,” according to the authors of the paper.

“As with any chemical, there are multiple steps involved in evaluating risk, which include gathering information about human exposures, so that the levels that produce harm in one population or animal species can be compared to typical exposure levels,” the authors wrote.

“However, we have previously shown that data on human exposure in workers and the general population are very limited. Several other gaps in knowledge exist around this product, for example results on its genotoxicity in humans are limited. The continued debate regarding the effects of glyphosate exposure makes establishing exposure levels in the general public a pressing public health issue, especially for the most vulnerable.”

The authors said monitoring of urinary glyphosate levels should be conducted in the general population.

“We continue to suggest that inclusion of glyphosate as a measured exposure in nationally representative studies like the National Health and Nutrition Examination Survey will allow for a better understanding of the risks that glyphosate may pose and allow for better monitoring of those who are most likely to be exposed and those who are more susceptible to the exposure,” they wrote.

New research adds evidence that weed killer glyphosate disrupts hormones

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New research is adding worrisome evidence to concerns that the widely used weedkilling chemical glyphosate may have the potential to interfere with human hormones.

In a paper published in the journal Chemosphere titled Glyphosate and the key characteristics of an endocrine disruptor: A review, a trio of scientists concluded that glyphosate appears to have eight out of ten key characteristics associated with endocrine disrupting chemicals . The authors cautioned, however, that prospective cohort studies are still needed to more clearly understand the impacts of glyphosate on the human endocrine system.

The authors, Juan Munoz, Tammy Bleak and Gloria Calaf, each affiliated with the University of Tarapacá in Chile, said their paper is the first review to consolidate the mechanistic evidence on glyphosate as an endocrine-disrupting chemical (EDC).

Some of the evidence suggests that Roundup, Monsanto’s well-known glyphosate-based herbicide, can alter the biosynthesis of the sexual hormones, according to the researchers.

EDCs may mimic or interfere with the body’s hormones and are linked with developmental and reproductive problems as well as brain and immune system dysfunction.

The new paper follows publication earlier this year of an assortment of animal studies that indicated glyphosate exposures impact reproductive organs and threaten fertility.

Glyphosate is the world’s most widely used herbicide, sold in 140 countries. Introduced commercially in 1974 by Monsanto Co, the chemical is the active ingredient in popular products such as Roundup and hundreds of other weed killers used by consumers, municipalities, utilities, farmers, golf course operators, and others around the world.

Dana Barr, a professor at Emory University’s Rollins School of Public Health, said the evidence “tends to overwhelmingly indicate that glyphosate has endocrine disrupting properties.”

“It’s not necessarily unexpected since glyphosate has some structural similarities with many other endocrine disrupting pesticides; however, it is more concerning because glyphosate use far surpasses other pesticides,” said Barr, who directs a program within a National Institutes of Health-funded human exposure research center housed at Emory. “Glyphosate is used on so many crops and in so many residential applications such that aggregate and cumulative exposures can be considerable.”

Phil Landrigan, director of the Global Observatory on Pollution and Health, and a professor of biology
at Boston College, said the review pulled together “strong evidence” that glyphosate is an endocrine disruptor.

“The report is consistent with a larger body of literature indicating that glyphosate has a wide range of adverse health effects – findings that overturn Monsanto’s long-standing portrayal of glyphosate as a benign chemical with no negative impacts on human health,” said Landrigan.

EDCs have been a subject of concern since the 1990s after a series of publications suggested that some chemicals commonly used in pesticides, industrial solvents, plastics, detergents, and other substances could have the capacity to disrupt connections between hormones and their receptors.

Scientists generally recognized ten functional properties of agents that alter hormone action, referring to these as ten “key characteristics” of endocrine-disruptors. The ten characteristics are as follows:

EDC’s can:

  • Alter hormone distribution of circulating levels of hormones
  • Induce alterations in hormone metabolism or clearance
  • Alter the fate of hormone-producing or hormone-responsive cells
  • Alter hormone receptor expression
  • Antagonize hormone receptors
  • Interact with or activate hormone receptors
  • Alter signal transduction in hormone-responsive cells
  • Induce epigenetic modifications in hormone-producing or hormone-responsive cells
  • Alter hormone synthesis
  • Alter hormone transport across cell membranes

The authors of the new paper said a review of the mechanistic data showed that glyphosate met all of the key characteristics with the exception of two:  “Regarding glyphosate, there is no evidence associated with the antagonistic capacity of hormonal receptors,” they said. As well, “there is no evidence of its impact on hormonal metabolism or clearance,” according to the authors.

Research over the last few decades has largely focused on links found between glyphosate and cancer, particularly non-Hodgkin lymphoma (NHL.) In 2015, the World Health Organization’s International Agency for Research on Cancer classified glyphosate as a probable human carcinogen.

More than 100,000 people have sued Monsanto in the United States alleging exposure to the company’s glyphosate-based herbicides caused them or their loved ones to develop NHL.

The plaintiffs in the nationwide litigation also claim Monsanto has long sought to hide the risks of its herbicides. Monsanto lost three out of three trials and its German owner Bayer AG has spent the last year and a half trying to settle the litigation out of court.

The authors of the new paper took note of the ubiquitous nature of glyphosate, saying “massive use” of the chemical has “led to a wide environmental diffusion,” including rising exposures tied to human consumption of the weed killer through food.

The researchers said that though regulators say the levels of glyphosate residue commonly found in foods are low enough to be safe, they “cannot rule out” a “potential risk” to people consuming foods containing contaminated with the chemical,  particularly grains and other plant-based foods, which often have higher levels than milk, meat or fish products.

U.S. government documents show glyphosate residues have been detected in a range of foods, including organic honey, and granola and crackers.

Canadian government researchers have also reported glyphosate residues in foods. One report issued in 2019 by scientists from Canada’s Agri-Food Laboratories at the Alberta Ministry of Agriculture and Forestry found glyphosate in 197 of 200 samples of honey they examined.

Despite the concerns about glyphosate impacts on human health, including through dietary exposure, U.S. regulators have steadfastly defended the safety of the chemical. The Environmental Protection Agency maintains that it has not found any human health risks from exposure to glyphosate.”

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.

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 addressingneurodevelopmental 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.

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

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.  

California Supreme Court denies review of Monsanto Roundup trial loss

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The California Supreme Court will not review a California man’s trial win over Monsanto, dealing another blow to Monsanto’s German owner, Bayer AG.

The decision to deny a review in the case of Dewayne “Lee” Johnson marks the latest in a string of court losses for Bayer as it tries to complete settlements with close to 100,000 plaintiffs who each claim they or their loved ones developed non-Hodgkin lymphoma from exposure to Roundup and other Monsanto weed killers. Juries in each of three trials held to date have found not only that the company’s glyphosate-based herbicides cause cancer but also that Monsanto spent decades hiding the risks.

“We are disappointed with the Court’s decision not to review the intermediate appeals court’s decision in Johnson and will consider our legal options for further review of this case,” Bayer said in a statement.  

The Miller Firm, Johnson’s Virginia-based law firm, said the California Supreme Court’s decision denied “Monsanto’s latest attempt to skirt responsibility” for causing Johnson’s cancer.

“Multiple judges have now affirmed the jury’s unanimous finding that Monsanto maliciously  concealed Roundup’s cancer risk and caused Mr. Johnson to develop a deadly form of cancer. The time has come for Monsanto to end its baseless appeals and pay Mr. Johnson the money it owes him,” the firm said.

A unanimous jury found in August 2018 that exposure to Monsanto’s herbicides  caused Johnson to develop a deadly form of non-Hodgkin lymphoma. The jury further found that Monsanto acted to hide the risks of its products in conduct so egregious that the company should pay Johnson $250 million in punitive damages on top of $39 million in past and future compensatory damages.

Upon appeal from Monsanto, the trial judge reduced the $289 million to $78 million. An appeals court then cut the award to $20.5 million, citing the fact that Johnson was expected to live only a short time.

The appeals court said it reduced the damages award despite finding there was “abundant” evidence that glyphosate, together with the other ingredients in Roundup products, caused Johnson’s cancer and that “there was overwhelming evidence that Johnson has suffered, and will continue to suffer for the rest of his life, significant pain and suffering.”

Both Monsanto and Johnson sought review by the California Supreme Court, with Johnson asking for restoration of a higher damage award and Monsanto seeking to reverse the trial judgment.

Bayer has reached settlements with several of the leading law firms who collectively represent a significant share of the claims brought against Monsanto. In June, Bayer said it would provide $8.8 billion to $9.6 billion to resolve the litigation.

Bayer’s Monsanto headache persists

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The migraine that is Monsanto doesn’t appear to be going away anytime soon for Bayer AG.

Efforts at settling the mass of lawsuits brought in the United States by tens of thousands of people who claim Monsanto’s Roundup herbicides gave them cancer continue to inch forward, but are not addressing all outstanding cases, nor are all plaintiffs offered settlements agreeing to them.

In a letter to U.S. District Judge Vince Chhabria, Arizona attorney David Diamond said that representations made by the lawyers leading settlement talks with Bayer on behalf of plaintiffs did not accurately reflect the situation for his own clients. He cited a “lack” of “settlement-related experiences” with Bayer and he requested that Judge Chhabria advance several of Diamond’s cases forward for trials.

“Leadership’s representations regarding settlement do not represent my clients’ settlement
related experiences, interests or position,” Diamond told the judge.

Diamond wrote in the letter that he has 423 Roundup clients, including 345 who have cases pending before Chhabria in the multidistrict litigation (MDL) in the U.S. District Court for the Northern District of California. Alongside the MDL are thousands of plaintiffs whose cases are pending in state courts.

Diamond’s outreach to the judge followed a hearing late last month in which several of the leading firms in the litigation and lawyers for Bayer told Chhabria they were close to resolving most, if not all, of the cases before the judge.

Bayer has reached important settlements with several of the leading law firms who collectively represent a significant share of the claims brought against Monsanto. In June, Bayer said it would provide $8.8 billion to $9.6 billion to resolve the litigation.

But controversy and conflict have dogged the overall settlement offers.

Several plaintiffs represented by the large firms and who spoke on condition that their names not be used, said they are not agreeing to the terms of the settlements, meaning their cases will be directed into mediation and, if that fails, to trials.

After buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs. The company lost all three of the three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides, such as Roundup, do cause cancer and that Monsanto spent decades hiding the risks.

The company’s efforts to resolve the litigation have been stymied in part by the challenge of how to head off claims that could be brought in the future by people who develop cancer after using the company’s herbicides.

Problems Just Keep Mounting  

Bayer has threatened to file for bankruptcy if it cannot quell the Roundup litigation and on Wednesday the company issued a profit warning and announced billions in cost cuts, citing a “lower than expected outlook in the agricultural market” amid other factors. The news sent shares in the company tumbling.

In reporting Bayer’s troubles Barron’s noted: “The problems just keep mounting for Bayer and its investors, who by now must be used to regular bouts of disappointing news. The stock has now fallen more than 50% since the Monsanto deal was closed in June 2018. “This latest update only adds to the case for the Monsanto deal being one of the worst in corporate history.”

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 since its introduction in 1974.
  • Worldwide 9.4 million tons 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.
  • Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced.

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. 

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.

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).

Roundup cancer trials still a threat to Bayer, but settlement talks progressing

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Lawyers for Monsanto owner Bayer AG and for plaintiffs suing Monsanto told a federal judge on Thursday that they were continuing to make progress in settling sweeping nationwide litigation brought by people who claim Monsanto’s Roundup caused them to develop cancer.

In a video hearing, Bayer lawyer William Hoffman told U.S. District Judge Vince Chhabria the company had reached deals – or was close to reaching deals – to resolve more than 3,000 lawsuits that are grouped together in multidistrict litigation (MDL) filed in U.S. District Court for the Northern District of California.

The company separately has already settled thousands of cases outside the MDL, cases that have been proceeding through state courts. But controversy and conflict have dogged the overall settlement offers, with allegations from some plaintiffs’ firms that Bayer reneged on agreements reached months ago, and some plaintiffs’ firms unwilling to agree to what they consider inadequate offers from Bayer.

There was no discussion of those complaints, however,  in Thursday’s hearing, with both sides expressing optimistic views.

“The company has moved forward and finalized several agreements with firms…. we’re also hopefully going to finalize additional agreements in the next several days,” Hoffman told the judge.

“Where we are right now… these figures are somewhat estimates but I think they are reasonably close: There are approximately 1,750 cases that are subject to agreements between the company and law firms and another approximately 1,850 to 1,900 cases that are in various stages of discussion right now,” Hoffman said. “We are working to put in place a program to accelerate discussions and hopefully bring agreements to fruition with those firms.”

Plaintiffs’ lawyer Brent Wisner told the judge it was important to note that there remain a “handful of cases” within the MDL that are not settled yet. But, he said – “We anticipate they will be shortly.”

Judge Chhabria said that given the progress he will continue a stay of the Roundup litigation until November 2 but that he will start moving cases to trial if they are not resolved by that point.

Bayer Bad Dealing Alleged

The cooperative tone expressed in Thursday’s hearing was a far cry from a hearing held last month when plaintiffs’ attorney Aimee Wagstaff  told Judge Chhabria that Bayer was not honoring tentative settlement agreements made in March and intended for finalization in July.

Bayer announced in June that it had reached a $10 billion settlement with U.S. law firms to resolve most of more than 100,000 Roundup cancer claims. But at that time the only major law firms leading the litigation that had final signed agreements with Bayer were The Miller Firm and Weitz & Luxenburg.

The Miller Firm’s deal alone totaled $849 million to cover the claims of more than 5,000 Roundup clients, according to settlement documents.

The  California-based Baum Hedlund Aristei &  Goldman law firm; the Andrus Wagstaff firm from Colorado; and the Moore Law Group of Kentucky had tentative deals but not final agreements.

According to a letter written by Wagstaff filed with the court, Bayer requested repeated extensions until the deal with her firm fell apart in mid-August. After reporting the issues to Judge Chhabria, the settlement talks resumed and were ultimately resolved with the three firms this month.

Some details of how the settlements will be administered were filed earlier this week in a court in Missouri. The Garretson Resolution Group, Inc., doing business as Epiq Mass Tort, will act as the
Lien Resolution Administrator,” for instance, for clients of Andrus Wagstaff whose settlement dollars will need to be used in part or in whole to repay cancer treatment expenses paid by Medicare.

Bayer bought Monsanto in 2018 just as the first Roundup cancer trial was getting underway. It has since lost all three of the three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s herbicides do cause cancer and that Monsanto spent decades hiding the risks.

The jury awards totaled well over $2 billion, though the judgments have been ordered reduced by trial and appellate court judges.

Bayer had threatened to file for bankruptcy if no nationwide settlement was reached, according to communications from the plaintiffs’ firms to their clients.

Thailand’s reversal on glyphosate ban came after Bayer scripted U.S. intervention, documents show

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A year ago Thailand was set to ban the widely used weed killing chemical glyphosate, a move applauded by public health advocates because of evidence the chemical causes cancer, along with other harms to people and the environment.

But under heavy pressure from U.S. officials, Thailand’s government reversed the planned ban on glyphosate last November and delayed imposing bans on two other agricultural pesticides despite the fact that the country’s National Hazardous Substances Committee said a ban was necessary to protect consumers.

A ban, particularly on glyphosate, would “severely impact” Thai imports of soybeans, wheat and other agricultural commodities, U.S. Department of Agriculture Undersecretary Ted McKinney warned Thailand Prime Minister Prayuth Chan-Ocha in pushing for the reversal. Imports could be impacted because those commodities, and many others, typically are laced with residues of glyphosate.

Now, newly revealed emails between government officials and Monsanto parent Bayer AG show that McKinney’s actions, and those taken by other U.S. government officials to convince Thailand not to ban glyphosate, were largely scripted and pushed by Bayer.

The emails were obtained through a Freedom of Information Act request by the Center for Biological Diversity, a nonprofit conservation organization. The group sued the U.S. Department of Agriculture (USDA) and the U.S. Department of Commerce on Wednesday seeking additional public records regarding the actions of the departments of trade and agriculture in pressuring Thailand on the glyphosate issue. There are several documents the government has thus far refused to release regarding communications with Bayer and other companies, the organization said.

“It’s bad enough that this administration has ignored independent science to blindly support Bayer’s self-serving assertions of glyphosate’s safety,” said Nathan Donley, a senior scientist at the Center for Biological Diversity. “But to then act as Bayer’s agent to pressure other countries to adopt that position is outrageous.”

Glyphosate is the active ingredient in Roundup herbicides and other brands developed by Monsanto, which are worth billions of dollars in annual sales. Bayer bought Monsanto in 2018 and has been struggling ever since to suppress mounting global concerns about scientific research showing that glyphosate herbicides can cause a blood cancer called non-Hodgkin lymphoma. The company is also fighting off lawsuits involving more than 100,000 plaintiffs who claim their development of non-Hodgkin lymphoma was caused by exposure to Roundup and other Monsanto glyphosate-based herbicides.

Glyphosate weed killers are the most widely used herbicides in the world, in large part because Monsanto developed genetically engineered crops that tolerate being sprayed directly with the chemical. Though useful to farmers in keeping fields free of weeds, the practice of spraying herbicide over the tops of growing crops leaves varying levels of the pesticide in both raw grain and finished foods. Monsanto and U.S. regulators maintain pesticide levels in food and livestock feed are not harmful to humans or livestock, but many scientists disagree and say even trace amounts can be dangerous.

Different countries set different legal levels for what they determine to be safe amounts of the weed killer in food and raw commodities. Those “maximum residue levels” are referred to as MRLs. The U.S. allows the highest MRLs of glyphosate in food when compared to other countries.

If Thailand banned glyphosate, the allowed level of glyphosate in food likely would be zero, Bayer warned U.S. officials.

High-level help

The emails show that in September 2019 and again in early October of 2019 James Travis, senior director for Bayer international government affairs and trade, sought assistance in reversing the glyphosate ban from multiple high-level officials from the USDA and the Office of the United States Trade Representative (USTR).

Among those Bayer sought aid from was Zhulieta Willbrand, who at that time was chief of staff of trade and foreign agricultural affairs at the U.S. Department of Agriculture.  After Thailand’s decision to reverse the ban on glyphosate, Willbrand was hired to work directly for Bayer on international trade matters.

When asked if the assistance from Willbrand while she was a government official helped her get a job at Bayer, the company said that it “ethically strives” to hire people from “all backgrounds” and any inference that she was hired for any reason other than the immense talent she brings to Bayer is false.”

In an email to Willbrand dated Sept. 18, 2019, Travis told her Bayer thought there was “real value” for U.S. government engagement on the glyphosate ban, and he noted that Bayer was organizing other groups to protest the ban as well.

“On our end, we are educating farmer groups, plantations and business partners so that they too can articulate concerns and the need for a rigorous, science based process,” Travis wrote to Willbrand. Willbrand then forwarded the email to McKinney, the USDA’s Under Secretary for Trade and Foreign Agricultural Affairs.

In an Oct. 8, 2019, email string with the subject line “Summary of Thailand Ban – Developments Moving Quickly,” Travis wrote to Marta Prado, deputy assistant U.S. Trade Representative for Southeast Asia and the Pacific, copying Willbrand and others, to update them on the situation.

Travis wrote that Thailand looked poised to ban glyphosate at a “dramatically” accelerated pace, by December 1, 2019. Along with glyphosate, the country was planning to also ban chlorpyrifos, an insecticide made popular by Dow Chemical that is known to damage babies’ brains; and paraquat, a herbicide scientists say causes the nervous system disease known as Parkinson’s.

Travis pointed out the risk a glyphosate ban would pose to sales of U.S. commodities because of the MRL issue and provided other background material the officials could use to engage with Thailand.

“In light of recent developments, we are growing more concerned that some policymakers and lawmakers are rushing the process and will not thoroughly consult all farming stakeholders nor fully consider the economic and environmental impact of banning glyphosate,” Travis wrote to the U.S. officials.

The email exchanges show that Bayer and U.S. officials discussed potential personal motivations of Thai officials and how such intelligence could be useful. “Knowing what motivates her may help with USG counter arguments,” one U.S. official wrote to Bayer about one Thai leader.

Travis suggested that U.S. officials engage much as they had with Vietnam when that country moved in April 2019 to ban glyphosate.

Shortly after the appeal from Bayer, McKinney wrote to the Thailand Prime Minister about the matter. In an Oct. 17, 2019 letter McKinney, who previously worked for Dow Agrosciences, invited Thailand officials to Washington for an in-person discussion about glyphosate safety and the Environmental Protection Agency’s determination that glyphosate “poses no meaningful risk to human health when used as authorized.”

“Should a ban be implemented it would severely impact Thailand’s imports of agricultural commodities such as soybean and wheat,” McKinney wrote. “I urge you to delay a decision on glyphosate until we can arrange an opportunity for U.S. technical experts to share the most relevant information to address Thailand’s concerns.”

A little more than a month later, on Nov. 27, Thailand reversed the planned glyphosate ban. It also said it would delay bans on paraquat and chlorpyrifos for several months.

Thailand did finalize bans of paraquat and chlorpyrifos on June 1, of this year. But glyphosate remains in use. 

When asked about its engagement with U.S. officials on the issue, Bayer issued the following statement:

Like many companies and organizations operating in highly regulated industries, we provide information and contribute to science-based policymaking and regulatory processes. Our engagements with all those in the public sector are routine, professional, and consistent with all laws and regulations.

The Thai authorities’ reversal of the ban on glyphosate is consistent with the science-based determinations by regulatory bodies around the world, including in the United StatesEuropeGermanyAustraliaKoreaCanadaNew ZealandJapan and elsewhere that have repeatedly concluded that our glyphosate-based products can be used safely as directed.

 Thai farmers have used glyphosate safely and successfully for decades to produce essential crops including cassava, corn, sugar cane, fruits, oil palm, and rubber. Glyphosate has helped farmers to improve their livelihoods and meet community expectations of safe, affordable food that is produced sustainably.”