Stephens trial drags on, toxicologist testifies about studies of herbicide and cancer risk

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A scientist testified Monday that a California woman’s regular use of Monsanto’s Roundup herbicide “vastly” exceeded the exposure scientific research shows more than doubles the risk of developing non-Hodgkin lymphoma (NHL).

William Sawyer, a toxicologist and expert witness for plaintiff Donnetta Stephens in her lawsuit against Monsanto, cited scientific research that links use of Monsanto’s glyphosate-based herbicides, including Roundup, to cancer and specifically to NHL.  Sawyer has testified in prior Roundup cancer trials, including a 2019 trial that resulted in a jury verdict of more than $2 billion for a husband-and-wife who both suffered from NHL.

The Stephens v. Monsanto trial has been underway for roughly three months, starting in late July. The proceedings have been  handled via Zoom, and multiple technical problems have at time hindered the delivery of testimony and sharing of evidence with jury members.

Jurors have heard from Stephens, her son, various cancer  experts and from some of Monsanto’s top scientists, including longtime Monsanto toxicologist Donna Farmer. Farmer now works for Bayer AG, the German pharmaceutical company that bought Monsanto in 2018.

“Perpetual” pain

Stephens’ trial is a “preference” case, meaning her case was expedited after her lawyers informed the court that Stephens was “in a perpetual state of pain” and losing cognition and memory.

The case is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa. Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Juries in the first three trials found in favor of the plaintiffs, agreeing with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma and Monsanto spent decades covering up the risks, and failing to warn users.

Monsanto won a recent trial involving a mother who claimed her son developed NHL because of exposure he experienced while she sprayed the weed killer.

More trouble for Bayer

Angry investors can proceed with litigation against Bayer over allegations that the company made misleading statements about its $63 billion 2018 acquisition of Monsanto, and of the extent of concerns about the company’s herbicide products.

A federal judge ruled last week that a class action led by a group of pension funds can proceed with their claims that Bayer proceeded with its purchase of Monsanto despite analyst warnings and an awareness that acquiring Monsanto brought significant risks, and assuring investors Bayer management had fully assessed those risks.

Bayer has settled several cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle a majority of the more than 100,000 existing Roundup cancer claims. The company recently said it was setting aside another $4.5 billion toward Roundup litigation liability.

Bayer also announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

Bayer wins Roundup trial; plaintiff fails to prove exposure caused child’s disease

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The former Monsanto Co., now owned by Bayer AG, notched its first win in the mass tort U.S. Roundup litigation on Tuesday, defeating at trial a mother who alleged her use of Roundup exposed her child to the pesticide and caused him to develop cancer.

Ezra Clark was born in May 2011 and diagnosed in 2016 with Burkitt’s lymphoma, a form of non-Hodgkin lymphoma (NHL) that has a high tendency to spread to the central nervous system, and can also involve the liver, spleen and bone marrow, according to the court filings. Ezra’s mother, Destiny Clark, is the plaintiff in the case, which was heard in Los Angeles County Superior Court. A different Roundup trial is underway in San Bernardino County Superior Court.

Ezra Clark was “directly exposed” to Roundup many times as he accompanied his mother while she sprayed Roundup to kill weeds around the property where the family lived, according to court documents. Ezra has autism and his mother said it calmed him to play outdoors while she worked in the yard, which meant he often played in areas freshly sprayed with Roundup, according to the court filings.

Fletch Trammell, lead attorney for Clark, said his case was subject to a bifurcation order that organized the case into two phases. In the first phase he was limited to presenting evidence that focused on the child’s personal exposure to Roundup and whether or not it could have been enough to have contributed to his disease. The case would have proceeded to a second phase had the plaintiff won the first phase, but the loss in the first phases ends the trial.

“This was nothing like any of the other three trials,” Trammell said.

The jury was asked to address one key question in the first phase: Whether or not the child’s exposure to  Roundup was a “substantial factor” in his development of Burkitt’s lymphoma.

In a 9 to 3 decision, the jury found that it was not.

Trammell said the jury decision was because the jury doubted the child’s exposure to Roundup could have been enough to cause cancer. The decision did not address the larger question of the alleged carcinogenicity of Roundup overall, he said.

But Bayer, which bought Monsanto in 2018 as the first Roundup trial was getting underway, said the jury’s decision was in line with scientific research showing glyphosate, the main ingredient in Roundup, is safe and does not cause cancer.

“The jury carefully considered the science applicable to this case and determined that Roundup was not the cause of his illness,” the company said in a statement.

80 hours

During the trial, Trammel presented evidence indicating Ezra was exposed to Roundup for about 80 cumulative hours over the years his mother sprayed with him at her side. He paired that with research showing there could ben an increased risk of NHL associated with repeated spraying of glyphosate herbicides, such as Roundup. And he noted language on Roundup labels in Canada that advise users to wear protective gloves and avoid getting the chemical on bare skin.

“The studies… they show that Roundup does three different things when it gets to your
lymphocyte cells…   It can kill cells, which is bad enough; but it also causes the exact DNA damage
that results in Burkitt’s lymphoma; it also, in a variety of ways, devastates your body’s ability to
repair DNA damage,” Trammell told jurors in his closing argument.

Trammell also sought to counter problems with deposition testimony given by Destiny Clark. Trammell said the mother also has suffered from cancer, a cervical cancer that metastasized to her brain. The illness and treatments she has undergone made it difficult for her to recall details and she “made a lot of mistakes” in the deposition she gave to Monsanto’s attorneys, Trammell told jurors. But she was very clear, he told jurors, on recalling her use of Roundup nearly “every weekend” when Ezra was young.

Monsanto attorney  Brian Stekloff told jurors that Ezra’s exposure was in doubt. He told jurors that while they might have sympathy for the family, they could not ignore inconsistencies in Destiny Clark’s testimony about how often her son was exposed, and could not ignore statements by other family members that they did not see her spraying around Ezra.

“And there is an old adage or old saying, and it goes like this: The truth is simple because there’s nothing to remember,” Stekloff told jurors. “When you tell the truth, you don’t mix up the facts. It’s when it didn’t happen that you can’t remember what you said the first time and the next time, and the next time, and the next time. And the inconsistencies start piling up and piling up, and the explanations start coming and piling up and piling up. And that’s what you have seen here in this trial.”

Stekloff told jurors the evidence did not support a finding that exposure to Roundup was a substantial factor in causing his cancer.

“This is not a popularity contest. This is not a referendum on Monsanto. It’s not even a referendum on Roundup,” he said in his closing argument. “Roundup did not cause Ezra Clark’s Burkitt’s lymphoma.”

Clark is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to NHL.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer has maintained that there is no cancer risk with the glyphosate herbicides it inherited from Monsanto, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Mike Miller, who heads the Virginia law firm that won two of the three previously held Roundup trials, i but who was not involved in the Clark case, said the verdict does not change anything about the litigation, nor Bayer’s liability.

“Nothing about that verdict change the fact: Roundup causes cancer,” he said.

See transcript of closing arguments in Clark v. Monsanto. 

Monsanto scientist tells jurors company’s side of Roundup cancer controversy

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A senior scientist at the former Monsanto Co. on Tuesday told jurors in a California trial that regulators around the world support the company’s position that its glyphosate-based herbicides, such as the popular Roundup brand, are safe for users.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying in the case of Donnetta Stephens v. Monsanto. Farmer has been a key witness in the Stephens case and was quizzed intently for days by lawyers for Stephens before Monsanto’s lawyers took up the questioning.

Stephens is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s Roundup and other herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

A chance to explain

Monsanto lawyer Monsanto lawyer Manuel Cachan questioned Farmer about several issues that were raised earlier by plaintiffs’ attorneys, telling Farmer it was her chance to explain details about several matters that Stephens’ lawyers had presented as evidence of Monsanto wrong-doing.

One such issue involved comments Farmer wrote in a 2003 email to colleagues about the importance of distinguishing between the chemical glyphosate and the Roundup formulation, which is made with glyphosate as the active ingredient.

In the email, Farmer wrote “The terms glyphosate and Roundup cannot be used interchangeably nor can you use “Roundup” for all glyphosate-based herbicides any more. For example you cannot say that Roundup is not a carcinogen… we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient.”

Plaintiffs’ lawyers have pointed to that language as part of a broad argument disputing Monsanto’s contention that thorough testing of Roundup has demonstrated it does not cause cancer.

In testimony Tuesday, Farmer said that she merely was trying to be “very precise” when explaining to colleagues the distinctions between products. She was not indicating in the email that there was any question about whether or not Roundup might cause cancer, Farmer testified.

She pointed out that in that internal email she also wrote “there is no reason to believe that Roundup would cause cancer.”

And though it was true at that time that Monsanto had not conducted extensive carcinogenicity testing on Roundup formulations, that changed over time, Farmer testified.

“I think we’ve got a lot more studies on Roundup than we had, and so I think we have a lot more information about the Roundup formulations that still supports the conclusions and safety about the formulation,” Farmer told the jury.

A regulatory pass

At another point in the questioning by Monsanto’s lawyer, Farmer told jurors that regulators had never required the company to conduct animal carcinogenicity testing on Roundup. She said not only had the U.S. EPA not demanded such testing, but regulators in Canada, Europe, Australia and Japan had similarly not required any such animal testing on Roundup products.

She also told jurors that while it was true that Roundup products contain formaldehyde, it was a “very, very small amount” and posed no danger to human health. Regulators agreed there was no reason for concern, Farmer testified.

“We produce formaldehyde every day in our bodies,” said Farmer. “Small amounts of formaldehyde like in the formulations at those low levels do not present a health hazard to humans.”

Farmer’s testimony sought to rebut other points of evidence raised by Stephens’ lawyers, seeking to cast Monsanto as a responsible, science-based organization that has been the innocent target of activist-driven misinformation. Plaintiffs’ lawyers have twisted internal conversations seen in emails and other communications to confuse and mislead jurors, according to arguments by Monsanto attorneys.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing they showed intentional efforts by the company to manipulate regulators and control scientific research.

Bayer, which bought Monsanto in 2018, has settled other cases that had been scheduled to go to trial. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. Bayer also recently said it would set aside another $4.5 billion toward Roundup litigation liability.

To try to quell future litigation, Bayer said it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

Paraquat Papers – Updates to U.S. litigation

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Multiple lawsuits are pending in the United States against Syngenta alleging the weedkilling chemical paraquat causes Parkinson’s disease.

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

But more than 100 lawsuits remain pending.

The lawsuits name Syngenta as well as 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.

Here is a list of actions pending through Judicial Council Coordination Proceedings (JCCP) as of Aug. 2, 2021

  • Harker v. Syngenta, et al. Case No. CGC-21-589755 (San Francisco Superior Court) (coordinated June 11, 2021)
  • De La Vega v. Syngenta, et al. Case No. C21-01057. (Contra Costa Superior Court) (coordinated July 19, 2021)
  • Louis Lombardo v. Syngenta et al., Alameda County Superior Court; Case No. RG21100757, filed on May 26, 2021 (coordinated July 19, 2021)
  • Lonnie Owens et al. v. Syngenta et al., Contra Costa Superior Court; Case No. C21-01187, filed on June 4, 2021 (coordinated July 19, 2021)
  • Borrelli v. Syngenta AG, et al. (Case No. MSC21-01217), filed June 24, 2021 in Contra Costa County Superior Court (coordinated July 23, 2021)
  • Isaak v. Syngenta AG, et al., San Francisco Superior Court; Case No. CGC-21591254 (coordinated August 2, 2021)
  • Rubino v. Syngenta, et al., Contra Costa County Superior Court Case No. C2101422 (coordinated August 2, 2021)
  • Aguiar v. Syngenta, et al. Case No. C21-01373. (Contra Costa Superior Court) (coordinated August 2, 2021)

Multidistrict litigation

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.

At least 86 lawsuits were pending within the MDL as of September 10, 2021.

Science

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 recently underwent the EPA’s registration review process,  and on August 2, 2021 the agency said paraquat would remain on the market with new safety measures aimed at reducing farmworker exposures. That followed the Oct. 23, 2020 release of a proposed interim decision (PID) for paraquat.  The interim decision proposed mitigation measures to reduce human health and ecological risks identified in the agency’s 2019 draft human health and ecological risk assessments.

Several organizations in September 2021 petitioned the 9th U.S. Circuit Court of Appeals, asking for the court to review and set aside the EPA’s decision. The petitioners include the California Rural Legal Assistance Foundation, Farmworker Association of Florida, Michael J. Fox Foundation for Parkinson’s Research, Farmworker Justice, Alianza Nacional de Campesinas, Pesticide Action Network North America, Center for Biological Diversity, and Toxic Free North Carolina. The groups claim the EPA is violating the Federal Insecticide, Fungicide, and Rodenticide Act

The EPA had indicated it would likely ban most aerial spraying of paraquat, but after industry lobbying efforts, the agency said it would allow such use with restrictions around residential areas.

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.”

In finding no evidence of a connection between paraquat and Parkinson’s, the EPA relied in part on input from the Agricultural Handler Exposure Task Force (AHETF),  a group that includes large agrochemical companies such as Syngenta AG, Bayer, Dow/Corteva, and others.

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

EPA exposed for hiding chemical risks, favoring corporate interests

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The U.S. Environmental Protection Agency (EPA) has a long and well-documented history of questionable conduct when it comes to regulation of chemicals important to the profit centers for many large and powerful corporations.  Numerous examples show a pattern of agency actions that allow for the use of dangerous chemicals by consumers, farmers, groundskeepers and others despite evidence of harm.

Documents and other evidence, including information provided in public disclosures by multiple EPA scientists, reveals actions in which EPA managers have intentionally covered up risks associated with certain chemicals. According to the evidence from these EPA insiders, pressure from chemical manufacturers, chemical industry lobbyists and from certain U.S. lawmakers drives internal agency manipulations that protect corporate interests but endanger public health.

Evidence indicates the misconduct dates back decades and has occurred in administrations led by Democrats and Republican alike.

A research project sponsored by Harvard University’s Edmond J. Safra Center for Ethics said while the EPA has “many dedicated employees who truly believe in its mission,” the agency has been “corrupted by numerous routine practices,” including a “revolving door” between EPA and industry in which corporate lawyers and lobbyists gain positions of agency power; constant  industry lobbying against environmental regulations; pressure from  lawmakers who are beholden to donors; and meddling by the White House.

Most recent news

Background: Blowing the whistle

The Frank R. Lautenberg Chemical Safety for the 21 Century Act, signed into law on June 22, 2016, was the first substantive reform to Toxic Substances Control Act (TSCA). The law requires EPA to make an affirmative determination on whether a new chemical substance presents an “unreasonable risk” to human health or the environment under “known, intended or reasonably foreseen conditions of use.” See information here.

Despite the law, the EPA has failed to make valid determinations about the risk presented by numerous chemicals.

In June 2021, four EPA scientists, each working within the agency’s Office of Chemical Safety and
Pollution Prevention (OCSPP), publicly accused the the EPA of deliberate tampering with chemical risk assessments. The four whistleblowers made their complaints public through a group called Public  Employees for Environmental Responsibility (PEER).

In a June 28 letter to the U.S. House Committee on Oversight and Reform, PEER said the four EPA scientists were providing “disturbing evidence of fraud and corruption,” involving “deliberate tampering with chemical risk assessments conducted under the Toxics Substances Control Act (TSCA), including PFAS (a.k.a. “forever chemicals”), and the deletion of potential health effects without the knowledge or consent of the human health assessors.”

The letter further states:

“All four clients have experienced numerous instances where their risk assessments were changed
by their managers or by colleagues in response to direction by management. These changes
include –
● Deleting language identifying potential adverse effects, including developmental toxicity,
neurotoxicity, mutagenicity, and/or carcinogenicity;
● Major revisions that alter the report conclusions to indicate that there are no toxicity
concerns despite data to the contrary; and
● Risk assessments being reassigned to inexperienced employees in order to secure their
agreement to remove issues whose inclusion would be protective of human health.”

As a result of the manipulations, people who work with these chemicals are not receiving information they need to protect themselves, such as “proper handling procedures, personal protection needed, accidental release measures, and first aid and firefighting measures,” according to PEER.
This is a particular concern for pregnant women, according to the PEER complaint.

Erasing important information

On August 26, 2021, PEER filed a separate complaint alleging that the EPA has been breaking the law by erasing original versions of internal communications and draft documents and retaining only the final version of key documents. The practice violates the Federal Records Act by eliminating details of the decision-making process from outside review, according to PEER.

PEER states that that discarding of documents trails is not only contrary to law but also violates the EPA’s own records retention policy. According to PEER, its complaint focuses on two classes of documents:

  • Alterations of chemical risk assessments by managers in which both the identity of the manager and the alterations themselves are not apparent; and
  • Internal comments related to the development of its Waters of the United States (WOTUS) rule, in which EPA software overwrote the original and all prior versions any time there was an edit. Thus, only the “final” version was saved.

“It is as if EPA memorializes its internal decision-making in disappearing ink,” PEER Executive Director Tim Whitehouse, a former EPA enforcement attorney, said in a press release. “EPA’s record-keeping practices allow unknown officials to make changes while disguising what precisely was changed and who changed them.”

PEER said it has asked the National Archives and Records Administration to intervene to prevent the EPA from destroying more records and to adopt safeguards to prevent any recurrences.

The case of Ruth Etzel

Ruth Etzel,  former director of the EPA’s Office of Children’s Health Protection (OCHP), filed a  whistleblower complaint with the U.S. Merit Systems Protection Board contending she was subject to illegal retaliation in 2018 and 2019. Etzel said the agency retaliated against her after she complained publicly about what she said was  EPA resistance to stronger public protections against lead poisoning.

At the EPA it was Etzel’s job to determine the impacts of regulations on children. But she alleges she was improperly removed from her position after speaking out about EPA failures, and was assigned to a division where she was not allowed to work on prevention of lead poisoning.

Etzel is both a pediatrician and an epidemiologist and is recognized internationally as an expert on child health and the environment. She was named the 2021 winner of the Public Policy and Advocacy Award by the Academic Pediatric Association.

More than 120 environmental and health organizations  complained to EPA about Etzel’s removal, saying the agency was sending a “signal that children’s health is not a priority for the agency.”

Reporting on EPA’s misconduct

See here information, including news articles, regarding alleged EPA misconduct and regulatory failures:

New evidence of corruption at EPA chemicals division, by Sharon Lerner, The Intercept, September 18, 2021

EPA whistleblower testifies her advocacy for stronger health protections drew agency retaliation, by Carey Gillam, USRTK, September 13, 2021

‘The harm to children is irreparable’: Ruth Etzel speaks out ahead of EPA whistleblower hearing, Carey Gillam, The Guardian, September 12, 2021

The EPA’s rationale for banning chlorpyrifos may make it harder to eliminate other brain-harming pesticides , Sharon Lerner, The Intercept, August 24, 2021.

Formaldehyde causes leukemia, according to EPA assessment suppressed by Trump officials, Sharon Lerner, The Intercept, August 19, 2021.

EPA exposed: Leaked audio shows pressure to overrule scientists in “hair-on-hire” cases,  Sharon Lerner, The Intercept, August 4, 2021.

Whistleblowers expose corruption in EPA chemical safety office, Sharon Lerner, The Intercept, July 2, 2021.

How pesticide companies corrupted the EPA and poisoned America, Sharon Lerner, The Intercept, June 30, 2021.

Flawed analysis of an intentional human dosing study and its impact on chlorpyrifos risk assessment,  Lianne Sheppard, Seth McGrew, Richard Fenske, Environment International, July 2020.

Further Efforts Needed to Uphold Scientific Integrity Policy at EPA,  U.S. Environmental Protection Agency Office of Inspector General, May 20, 2020.

EPA Allowed Companies to Make 40 New PFAS Chemicals Despite Serious Risks, Sharon Lerner, The Intercept, September, 19, 2019.

E.P.A. Won’t Ban Chlorpyrifos, Pesticide Tied to Children’s Health Problems, Lisa Friedman, New York Times, July 18, 2019.

Emails show Trump EPA overruled career staff on Wisconsin air pollution, Timothy Gardner, Reuters, May 28, 2019.

US environment agency cuts funding for kids’ health studies, Sara Reardon, Nature, May 13, 2019.

Meet 3 women who stood up to Trump to protect the American people — and lost their jobs,  The Hill, January 19, 2019.

White House, EPA headed off chemical pollution study, Annie Snider, Politico, May 14, 2018.

Whitewash: The Story of a Weed Killer, Cancer, and the Corruption of Science, Carey Gillam, Island Press, October 10, 2017.

Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto, Carey Gillam, Huffington Post, August 18, 2017.

EPA Official Accused of Helping Monsanto “Kill” Cancer Study, Joel Rosenblatt, Lydia Mulvany, and Peter Waldman, Bloomberg, March 14, 2017.

Poison Spring- The Secret History of Pollution and the EPA, Evaggelos Vallianatos and McKay Jenkins, Bloomsbury Press, April 14, 2014.

Monsanto scientist defends Roundup safety in California trial

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A senior scientist at the former Monsanto Co. told jurors in a California trial that the company’s Roundup herbicide is so safe that the scientist uses it regularly at her home, and suggests friends also use the weed killing product.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying Monday and on multiple days last week in the case of Donnetta Stephens v. Monsanto. The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

Stephens is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer, which bought Monsanto in 2018, insists there is no cancer risk with its glyphosate herbicides, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Combative exchanges

In testimony delivered under cross-examination by Stephens’ lawyer William Shapiro, Farmer was combative, going beyond answering the yes or no questions Shapiro posed to her in an effort to “explain” the context she said Shapiro was misrepresenting.

Shapiro quizzed Farmer about emails and documents dating back to the late 1990s that Shapiro presented as evidence that Farmer and other company scientists engaged in misconduct, including ghostwriting scientific papers to fraudulently assert the safety of its glyphosate-based herbicides and buried information that found cancer risk with the products.

On Monday, Monsanto lawyer Manuel Cachan questioned Farmer about many of the same pieces of evidence focused on by Shapiro, but cast the emails and other evidence as innocent exchanges that bear no signs of deceit or misconduct.

Under Cachan’s questioning, Farmer said that based on the science that she is familiar with, she does not believe glyphosate causes cancer, and is confident that Roundup is safe to use. She said that she is so certain of the safety of Roundup that she has used it around her yard for about 25 years. She does not wear gloves or special protective gear when spraying, she testified. Farmer said she has no worries about recommending the product to family members and friends.

Farmer said the phase-out for consumers is not due to any safety concerns and is being removed from consumer markets simply “because of the litigation and the lawsuits.” Farmer said she does not think the product should be withdrawn.

“The product is in my opinion – and not just my opinion but regulators around the world – the product is safe and is not a carcinogen,” Farmer testified.

Even after Bayer stops selling Roundup to consumers in 2023, Farmer said she plans to keep using it.

“It has a good shelf life so I’ll probably buy some extra bottles,” she said. “You can go to dealerships in farm country, you can buy some of the products there.”

Monsanto has been persecuted by an anti-pesticide movement, according to Farmer.

“There are a lot of people who don’t like pesticides. They don’t like glyphosate and quite frankly don’t like Monsanto. There are a lot of people who make allegations and spread misinformation about the safety of our products,” Farmer testified.

Beyond Pesticides

At one point in her testimony, Farmer weighed in on a nonprofit group and Monsanto critic called Beyond Pesticides, telling jurors that Beyond Pesticides was not a scientific group but rather an activist group that was “misrepresenting the science” about synthetic pesticides such as glyphosate.

“Their mission is to stop the use of synthetic pesticides and so what they publish is misinformation, inaccurate information about pesticides,” she testified.

Monsanto’s lawyer asked her to address a 2008 internal Monsanto email regarding a press release issued by Beyond Pesticides. The press release by the nonprofit group shared a research study that found glyphosate exposure could increase a person’s risk of developing non-Hodgkin lymphoma. The group advised people should embrace organic agriculture and use “non-toxic land care” on residential lawns.

In the email, Farmer had written to colleagues: “We have been aware of this paper for awhile and knew it would only be a matter of time before the activists picked it up.” Mentioning the Beyond Pesticides line about embracing organic agriculture, Farmer had written: How do we combat this?”

Under questioning from Monsanto’s lawyer, Farmer explained that she was not indicating Monsanto should try to combat the scientific research but was addressing only the Beyond Pesticide advice about avoiding pesticide use.

The Stephens trial started as an in-person proceeding but was changed to a Zoom trial due to concerns about the spread of Covid-19, and has been plagued by repeated “technical problems” ever since the change. Several times jurors and/or a witness have lost their audio and/or video connections to the trial.

Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California, is overseeing the proceedings.

The trial does not resume until Monday Oct. 4 because of scheduling conflicts for some of the trial participants.

EPA’s “scientific integrity” program lacks teeth, group alleges

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Insiders at the Environmental Protection Agency (EPA) have alleged dozens of violations of the agency’s “scientific integrity” policy over the last few years, including complaints of political interference and tampering with chemical risk assessments, but nearly all the complaints have been ignored, according to an analysis conducted by a nonprofit group representing EPA employees.

Seven complaints were filed very recently- between January and July of this year, according to EPA data obtained by the group.

Since 2017 there have been a total of 68 allegations of scientific integrity violations inside the EPA, including 35 allegations filed between 2019 and mid-year 2021, according to Public Employees for Environmental Responsibility (PEER).

PEER is currently representing four EPA scientists who have come forward as whistleblowers, offering internal agency emails and other documents as evidence of what they allege is wide-spread corruption driven by powerful political and corporate influences.

Among other things, those whistleblowers have claimed specifically that chemical risk assessments have been altered, or otherwise tampered with, in order to make chemicals entering the marketplace appear safer than they actually are. The result leaves the public exposed to chemicals that may cause cancer, developmental problems or other hidden health risks.

Importantly, the whistleblowers have said that agency misconduct has continued through the first several months of the Biden administration.

The information obtained by PEER shows that of the 35 allegations filed from 2019 through June 2021, 12 were closed, 22 remained unresolved and only one was deemed “substantiated,” but even that one has not led to any punishment.

“It’s a complete sham,” Jeff Ruch, one of PEER’s regional directors and former executive director, said of the EPA’s scientific integrity program. “They give the illusion that they have a program, but it’s worse than nothing because it suggests they’re holding themselves to a high standard of scientific integrity when they’re not.”

Interference

The EPA has publicly reported scientific integrity complaint information through 2018, but has not filed public reports for complaint information since. The data for 2019 through June of 2021 was procured by PEER through a Freedom of Information Act request. The nonprofit requested details about the complaints and their handling but EPA provided only very limited information illustrated in pie charts.

The information in the pie charts shows that “interference” in scientific work ranked as the most often-cited type of complaint. Five of the seven complaints recorded for the first half of 2021 were for interference, for instance.

Shortly after taking office, President Biden launched a review of federal scientific integrity policies, saying “Scientific findings should never be distorted or influenced by political considerations.”

The directive said ”Improper political interference in the work of Federal scientists… undermines the welfare of the Nation, contributes to systemic inequities and injustices, and violates the trust that the public places in government to best serve its collective interests.”

In one example of such interference, PEER filed a complaint last year with the EPA’s Office of  Inspector General charging that then EPA Administrator Andrew Wheeler, along with other high-ranking EPA officials, excluded key scientific information and the analysis of experts​ in changing the definition of “water of the United States” under the Clean Water Act, a move PEER and others said threatened clean drinking water around the country. 

“Major” hindrances

PEER describes what it calls “major” hindrances within the EPA’s Scientific Integrity program, including a “lack of investigative staff,” an “inability to draw upon expertise needed to assess technical issues,” and the “absence of any protocol for reviewing or investigating complaints.”

And notably, violations of the agency’s scientific integrity policy carry no penalties, PEER said.  The group’s experience representing whistleblowers indicates violations are largely addressed by trying to “persuade non-compliant managers to address their own violations,” PEER said.

The group said with respect to the current whistleblower complaints PEER is involved in, the EPA scientists notified the agency’s office of scientific integrity last November about their concerns about a memorandum that made policy changes they scientists said weakened human health assessments in a way that made them less likely to find risks with a new chemical substance. Their concerns were ignored for months, according to PEER. The memorandum was eventually revoked, but the altered chemical assessments were not corrected and the scientists fear the policy memo will be reinstituted, according to PEER.

In the EPA’s 2018 report, the agency said that “Scientific integrity remains an ongoing priority for EPA,” and said the agency works with special advisors and committees and engages the Office of Inspector General (OIG) when needed to protect and advance the integrity of the agency’s scientific work.

“Scientific integrity is the compass that guides EPA in its mission to protect human health
and the environment,” the agency states in the report.

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:

Consumer market withdrawal planned 

In July 2021, Monsanto owner Bayer AG said it would remove glyphosate-based herbicides from the U.S. consumer market by 2023 due to tens of thousands of lawsuits brought by people alleging they developed non-Hodgkin lymphoma from exposure to the company’s glyphosate herbicides, such as Roundup.

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 

  • Statement by the International Federation of Gynecology and Obstetrics (FIGO) Reproductive and Environmental Health Committee: “We recommend that glyphosate exposure to populations should end with a full global phase out.” (7.2019) 
  • Essay in Journal of Epidemiology and Community Health: “Is it time to reassess safety standards for glyphosate based herbicides?” (6.2017)
  • Consensus statement in Environmental Health Journal: “Concerns over use of glyphosate-based herbicides and risks associated with exposures: a consensus statement” (2.2016)
  • Monsanto owner Bayer AG maintains that glyphosate and glyphosate-based herbicides are safe when used as directed and do not cause cancer.  “Glyphosate is one of the most studied herbicides in the world – and, like all crop protection products, it is subject to rigorous testing and oversight by regulatory authorities,” Bayer states on its website. “There is an extensive body of research on glyphosate and glyphosate-based herbicides…  that confirm that glyphosate and our glyphosate-based formulated products can be used safely and do not cause cancer.”  

Concerns with corporate studies

Regulators in Europe and the United States, Canada and elsewhere have repeatedly affirmed the corporate assertions of glyphosate safety. In coming to determinations about safety these regulators have relied in part on tests that are conducted by or for the companies that have not been published or peer reviewed.  

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. More than 50 of those corporate studies were analyzed in 2021 by two independent scientists – Armen Nersesyan and Siegfried Knasmueller, both from the Institute of Cancer Research, Department of Medicine at the Medical University of Vienna.

The goal of the analysis was to determine if the industry studies examined comply with current international guidelines for chemical testing. 

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. See more details here. 

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.

Neurotoxicity

  • A large nationwide study published in the journal NeuroToxicology (December 2021) reports that “several neurotoxic pesticide exposures estimated using residential location were associated with statistically significant increased risk of ALS (amyotrophic lateral sclerosis). These include the herbicides 2,4-D and glyphosate, and the insecticides carbaryl and chlorpyrifos.” ALS is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. 

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

Despite having annual pesticide residue testing programs for more than 30 years, the U.D. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) mostly skipped testing food for glyphosate until after criticism from the Government Accountability Office in 2014. The USDA said it would start testing but then dropped the plan 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. The FDA did later resume limited testing. 

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:

Residues of glyphosate and other pesticides in food

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.”

In 2020, a group of FDA scientists published a research paper  examining pesticide residue data collected from 2009-2017. The scientists said this: “In this study, results for over 56,000 human food samples collected and analyzed under the FDA pesticide residue monitoring program between fiscal years (FY) 2009 to 2017 were reviewed to identify trends not apparent in annual reports. The overwhelming majority of these samples, 98.0% of domestic and 90.9% of import human foods, were compliant with federal standards. Although herbicides may be more widely used, the 10 most frequently detected residues were insecticides and fungicides. On a yearly basis, the violation rate for imported samples is 3-5 times higher than the rate for domestic samples. The import violation rate increased over time, as did the number of residues detected. Targeted sampling of foods with higher commodity-specific violation rates appears to be a major contributor to the increased violation rate. Mismatches between US tolerances and international MRLs can lead to violations; this was especially marked for rice. Overall, the majority of violations are due to residues of pesticides not authorized for use in the US (lack of tolerances). While DDT continues to persist in the environment and was found in 2.2% of domestic samples and 0.6% of imported samples, 42.3% of DDT-positive samples were below the limit of quantitation. The trends and analyses identified in this paper may help FDA plan future sampling and continue to protect the food supply.”

Monsanto owner Bayer AG maintains that residues of glyphosate in food are not harmful at levels approved by the Environmental Protection Agency.  A 2021 paper written by longtime Bayer (former Monsanto) scientist John Vicini and published in Comprehensive Reviews in Food Science and Food Safety states that  “dietary exposures to glyphosate are within established safe limits.” 

For a complete history of the use of glyphosate, including regulatory action and inaction, scientific controversies, human and environmental impact data, read Whitewash – The Story of a Weed Killer, Cancer and the Corruption of Science, winner of the 2018 Rachel Carson Book Award from the Society of Environmental Journalists.

Cancer patient lawyer spars with Monsanto scientist in California Roundup trial

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A lawyer for a woman claiming her use of Roundup herbicide caused her to develop non-Hodgkin lymphoma sparred with a longtime Monsanto scientist in court on Wednesday, forcing the scientist to address numerous internal corporate documents about research showing Monsanto weed killers could be genotoxic and lead to cancer.

The testimony by former Monsanto scientist Donna Farmer marked her second day on the stand and  came several weeks into the case of Donnetta Stephens v. Monsanto, the fourth Roundup trial in the United States, and the first since 2019. Juries in three prior trials all found in favor of plaintiffs who, like Stephens, alleged they developed non-Hodgkin lymphoma due to their use of Roundup or other Monsanto herbicides made with the chemical glyphosate. Thousands of people have filed similar claims.

Bayer AG, which bought Monsanto in 2018, has earmarked more than $14 billion to try to settle all of the U.S. Roundup litigation, but many plaintiffs have refused to settle, and cases continue to go to trial.

A “genotox hole”

In hours of contentious back-and-forth, interrupted repeatedly by objections from a Monsanto attorney, Stephens’ lawyer William Shapiro quizzed Monsanto toxicologist Donna Farmer about emails and documents dating back to the late 1990s that focused on research – and the company’s handling of that research – into whether or not the company’s herbicide products could cause cancer.

In one line of questioning, Shapiro asked Farmer about emails in which she and other company scientists discussed the company’s response to outside research that concluded the company’s glyphosate-based herbicides were genotoxic, meaning they damaged human DNA. Genotoxicity is an indicator that a chemical or other substance may cause cancer.

Shapiro focused during one series of questions on work done by a scientist named James Parry, who Monsanto hired as a consultant in the 1990s to weigh in on the genotoxicity concerns about Roundup being raised at the time by outside scientists. Parry’s report agreed there appeared to be “potential genotoxic activity” with glyphosate, and recommended that Monsanto do additional studies on its products.

In an internal Monsanto email dating from September 1999 written to Farmer and other company scientists, a Monsanto scientist named William Heydens said this about Parry’s report: “let’s step back and look at what we are really trying to achieve here. We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and can be influential with regulators and Scientific Outreach operations when genetox issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there. We simply aren’t going to do the studies Parry suggests.”

In a separate email revealed through the litigation, Farmer wrote that Parry’s report put the company into a “genotox hole” and she mentioned a suggestion by a colleague that the company should “drop” Parry.

Farmer testified that her mention of a “genotox hole” referred to problems with “communication” not about any cancer risk. She also said that she and other Monsanto scientists did not have concerns with the safety of glyphosate or Roundup, but did have concerns about how to respond to paper and research by outside scientists raising such concerns.

Shapiro pressed Farmer on her reaction to Parry’s finding: “You thought it would be okay on behalf of Monsanto to receive information as you did from Dr. Parry that this Roundup product was genotoxic or could be, you thought it would be okay to go ahead and continue to sell the product, correct?”

Farmer replied: “We didn’t agree with Professor Parry’s conclusions at the time that it may be, could be, capable of being genotoxic. We had other evidence….  We had regulators who had agreed with our studies and conclusions that it was not genotoxic.”

Her answer was interrupted as Shapiro objected, saying he was asking a yes or no question and Farmer’s attempt to respond beyond that should be stricken. The judge agreed and struck part of the response.

Continuing his questioning, Shapiro asked: “Well that didn’t work out to have Dr. Parry be the spokesperson for Monsanto, did it Dr. Farmer?

“I would disagree with you because there is still a lot more to this Professor Parry, working with him, and I’d be happy to…” Farmer replied before being cut off by another Shapiro objection and the judge’s striking of everything following the first five words.

A similar pattern played out throughout Farmer’s testimony as Stephens’ lawyer objected to Farmer’s attempts to provide extended answers to multiple questions posed, and Monsanto’s lawyer Manuel Cachan objecting repeatedly to Shapiro’s questions as “argumentative.”

Ghostwriting and “FTO”

Shapiro asked Farmer to address multiple issues expressed in the internal corporate emails, including one series in which Monsanto scientists discussed ghostwriting scientific papers, including a very prominent paper published in the year 2000 that asserted there were no human health concerns with glyphosate or Roundup.

Shapiro additionally asked Farmer to address a strategy Monsanto referred to in emails as “Freedom to Operate” or “FTO”. Plaintiffs’ lawyers have presented FTO as Monsanto’s strategy of doing whatever it took to lessen or eliminate restrictions on its products.

And he asked her about Monsanto emails expressing concerns about research into dermal absorption rates – how fast its herbicide might absorb into human skin.

Farmer said multiple times that information was not being presented in the correct context, and she would be happy to provide detailed explanations for all of the issues raised by Shapiro, but was told by the judge she would need to wait until questioning by Monsanto’s lawyers to do so.

Zoom trial

The Stephens trial is taking place under the oversight of Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California. The trial is being held via Zoom due to concerns about the spread of Covid-19, and numerous technical difficulties have plagued the proceedings. Testimony has been halted multiple times because jurors have lost connections or had other problems that inhibited their ability to hear and view the trial testimony.

Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The three prior trials were all lengthy, in-person proceedings loaded with weeks of highly technical testimony about scientific data, regulatory matters and documents detailing internal Monsanto communications.

Litigation against Syngenta grows; lawyers fight over evidence and trial dates

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Syngenta AG is facing a growing number of U.S. lawsuits over allegations that its paraquat herbicide causes Parkinson’s disease, with a Fresno, California man pushing for an expedited trial that potentially would start within the next few months, and multiple plaintiffs’ lawyers jockeying for power and influence over future trial proceedings.

Plaintiff George Isaak used paraquat to treat weeds on orchard and vineyard property from 1964 through 2004, mixing, loading and spraying the pesticide routinely before he was diagnosed with Parkinson’s in May of 2020, according to his lawsuit.

Isaak used a 200-gallon “spraying rig” on the 60-acre farm where he raised peaches, nectarines, almonds, pistachios, and grapes before retiring in 2005. Isaak, 84, now has such severe Parkinson’s symptoms that he has suffered several falls, finds it hard to speak, and is confined to a wheelchair, according to his lawyers.

Isaak attorney Mike Miller said his client has been left with “horrible” injuries from Parkinson’s.

Isaak should now be given a trial date no later than January due to his decline in cognition and overall debilitation to his health, according to a court filing by The Miller Firm and co-counsel.

Isaak “had no reason to suspect that chronic, low-dose exposure to Paraquat could cause neurological diseases such as Parkinson’s disease,” the lawsuit states. But evidence will show, the lawsuit contends, that the paraquat use was a “substantial factor in causing Plaintiff George Isaak to suffer severe and permanent physical injuries, pain, mental anguish, and disability, and will continue to do so for the remainder of Plaintiff George Isaak’s life.”

Carol Isaak, George Isaak’s wife, is also a plaintiff in the lawsuit and is seeking a claim for loss of consortium.

There are hundreds of cases pending in state and federal courts around the country, according to a June 22 court filing. The plaintiffs in those cases all allege Syngenta was aware of the risks but failed to warn users.

Syngenta, which is owned by a Chinese chemical company, has denied the allegations, and is seeking to dismiss, or limit the lawsuits. The company filed a “partial motion to dismiss” in federal court on Sept. 13, citing various state law provisions in asking the court to dismiss claims “for breach of warranty, fraud, and violation of certain consumer protection statutes.”

Along with Syngenta, the defendants include Chevron Phillips Chemical Cmpany LP, and Chevron USA, Inc. All have denied any liability.

Infighting among plaintiffs’ lawyers

Syngenta said in a Sept. 17 court filing that it opposes the granting of an expedited trial, known as a “preference” trial, for Isaak.

“Mr. Isaak has presented no evidence regarding his alleged paraquat exposures, and his medical records and doctor’s declaration cast doubt on whether he actually has Parkinson’s disease,” the company said in its filing.

Syngenta noted that there are many other plaintiffs expected to request preference trials.

In addition to the objection from Syngenta, Isaak’s lawyers effort to obtain court approval for a preference trial has come into conflict with an effort by other attorneys representing other plaintiffs in the paraquat litigation.

Plaintiffs law firm Walkup, Melodia, Kelly & Schoenberger is seeking to create a special committee made up of plaintiffs’ lawyers that would evaluate and screen cases seeking preference trials. Typically such requests for expedited trials go directly to a judge.

The firm said a committee was needed because many of the plaintiffs in the overall paraquat litigation would “likely qualify” for preference. They are proposing a protocol implemented by a five-member committee of plaintiffs’ lawyers.

“The majority of the plaintiffs, including both filed and unfiled cases known to plaintiffs’ counsel, are over the age of 65. The reality of these cases is that there are many plaintiffs, as well as many potential plaintiffs, whose disease progression is unstable and who have a real and substantial danger of losing their ability to testify, or losing their ability to meaningfully utilize their compensation, if their trials are not prioritized,” the firm stated in a court filing.

The firm added in a separate filing: “An uncontrolled race to file competing preference motions risks sending a plaintiff to trial who does not represent the plaintiff population. And should the initial trials be ultimately unsuccessful, it jeopardizes the rights of all remaining plaintiffs in the proceeding.”

Isaak’s lawyers oppose the formation of such a committee and filed a memorandum explaining that opposition on Sept. 17, arguing that the use of a preference committee is “unconstitutional on its face.”

Whether or not a plaintiff meets the criteria deserving of a preference trial should not be left up to the arbitrary nature of a committee of other plaintiffs’ attorneys, they said.

The attorneys registering opposition to the preference committee additionally allege that the Walkup firm has a conflict of interest because it has already reached a “large, lucrative” settlement agreement with Syngenta for some of its clients, and until that deal is finalized, Syngenta and the other defendants still could walk away from the deal.

Thus, the Walkup firm is “a conflicted law firm,” the attorneys allege. In addition to The Miller Firm, the law firms registering opposition are the Wagstaff Law Firm and Brady Law Group.

A hearing on the matter is set for Sept. 30.

Battle over discovery documents

The lawyers for plaintiffs have also been fighting over access to internal Syngenta corporate documents and other evidence obtained as part of court-ordered “discovery.”

Over the last few years, Syngenta and the other defendants turned over millions of documents to Missouri lawyer Steve Tillery in his representation of a paraquat lawsuit titled Hoffman V. Syngenta, that was pending in St. Clair County, Illinois. The Hoffman case had been set to go to trial earlier this year but Tillery and the defendants agreed to a settlement and no trial was held.

The lawyers for the plaintiffs pursuing trials want to make use of the materials already turned over in the Hoffman case, including internal corporate documents as well as depositions and expert reports. Tillery and Syngenta objected to sharing some of the materials but were ordered to do so by the federal judge overseeing consolidated paraquat proceedings in the Northern District of California.

Scientific studies

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.

A 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.”

Because the paraquat litigation is expected to continue to grow, the U.S. Judicial Panel on Multidistrict Litigation (MDL) in Washington, D.C. approved the consolidation of pretrial proceedings in the Northern District of California, the same federal court that is overseeing the U.S. Roundup MDL.

Similarly, several other cases are consolidated in Judicial Council Coordination Proceedings in Contra Costa County Superior Court in California.