PFAS: Health Concerns and Efforts to Regulate “Forever Chemicals”

Posted on November 22, 2021 by Carey Gillam

Per- and Polyfluoroalkyl Substances (PFAS) are a group of thousands of manufactured chemicals widely used by a range of industries and commonly found in a large number of household products. One common characteristic of PFAS is that they persist in the environment and can accumulate in humans and animals. For this reason, they are often referred to as “forever chemicals.”

Some PFAS have been linked to cancer, birth defects, liver disease, thyroid disease, decreased immunity, hormone disruption and a range of other serious health problems.

The U.S. Centers for Disease Control and Prevention (CDC) says that most people in the United States have been exposed to some PFAS. The chemicals have been documented in the blood of people and animals around the world, and also have been found to be pervasive in the environment, particularly in areas where manufacturers or other industrial users are actively handling PFAS.

In response to a Freedom of Information Act request, the U.S. Environmental Protection Agency (EPA) in 2021 released a spreadsheet of more than 120,000 facilities around the United States the regulatory agency fears are handling PFAS. Download that spreadsheet here.

Researchers have identified the following routes of exposure to PFAS:

Drinking water – in public drinking water systems and private drinking water wells.
Soil and water at or near waste sites – at landfills, disposal sites, and hazardous waste sites.
Fire extinguishing foam – used in training and emergency response events at airports, shipyards, military bases, firefighting training facilities, chemical plants, and refineries.
Manufacturing or chemical production facilities that produce or use PFAS – such as oil and gas drilling sites, chrome plating, electronics, and certain textile and paper manufacturers.
Food – such as fish caught from water contaminated by PFAS and dairy products from livestock exposed to PFAS, and other foods.
Food packaging – such as grease-resistant paper, fast food containers/wrappers, microwave popcorn bags, pizza boxes, and candy wrappers.
Household products- such as stain and water-repellent used on carpets, upholstery, clothing, and other fabrics; cleaning products; non-stick cookware; paints, varnishes, and sealants.
Personal care products- such as shampoos, dental floss, and cosmetics.

Long history of warnings about health risks of PFAS

Environmental and human health experts and advocates have long been critical of the EPA for a lack of research into, and regulation of, PFAS. Researchers, lawyers and environmental and human health advocates have warned about the dangers of PFAS for roughly 20 years, and evidence has come to light showing that companies involved in manufacturing PFAS have known about dangers to human health even longer.

Research has demonstrated that two types of PFAS – Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS), are very harmful to humans and animals. In 2016, the National Toxicology Program (NTP) concluded that PFOA and PFOS were a specific hazard to immune system function in humans. U.S. manufacturers have been replacing those types of PFAS with other types, though concerns persist about the replacements.

On Nov. 16, 2021, the EPA said it was sending four “draft documents” to its Scientific Advisory Board that contain new data and analyses. The new information indicates that “negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is a likely carcinogen,” according to the EPA.

PFOA, also known as C8, was a key ingredient in non-stick Teflon products. C8 was originally manufactured by 3M and then by DuPont until the health hazards of the chemical were made public through a class-action lawsuit. A replacement chemical called GenX was introduced by DuPont in 2009 as a safer alternative to PFOA, but an investigation by The Intercept found that DuPont filed 16 reports with the EPA citing numerous harmful health effects of the chemical on animals, sparking concerns about the safety of the substitute.

A C8 science panel was formed as part of the settlement of a class-action lawsuit approved in February 2005 by West Virginia Circuit Court. That case involved allegations that human health problems were caused by releases of C8 from a DuPont facility in West Virginia.

The science panel was charged with conducting a community study to help evaluate potential links between C8 exposure and any human disease. The research findings are detailed here.

The litigation and settlement were largely the work of U.S. lawyer Robert Bilott.

Bilott has spent the last two decades advocating for strict PFAS regulation and corporate accountability for PFAS pollution. His investigation into PFAS, including the corporate efforts to cover up the harms of the chemicals, have been documented in a book, a feature film and a documentary film, among other works.

In 2018, the U.S. Centers for Disease Control and Prevention (CDC) published a 852-page review of PFAS health dangers, challenging the EPA’s determination of what the regulator considered safe levels for some of the compounds, finding that exposures could be a threat at many times lower than what the EPA had established.

In October 2021, the EPA released what it described as a “strategic roadmap” aimed at restricting PFAS from being released into the environment. The plan also is supposed to accelerate the cleanup of existing PFAS contamination. The EPA said highlights of its plan include:

“Aggressive” timelines to set enforceable drinking water limits under the Safe Drinking Water Act “to ensure water is safe to drink in every community”.

Timelines for actions involved in the establishment of “effluent guideline limitations”, for nine industrial categories.

Establishment of a hazardous substance designation under the federal Superfund law that enhances the government’s ability to hold PFAS polluters financially accountable.

A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficient.

Increased monitoring, data collection and research so that the agency can identify what actions are needed and when to take them.

A final toxicity assessment for a type of PFAS called GenX used in manufacturing nonstick coatings that has been found in drinking water, rainwater and air samples.

Continued efforts to address PFAS emissions into the air.

The agency said it will also be increasing investments in research related to PFAS. U.S. President Joe Biden has called for more than $10 billion in funding to “monitor and remediate PFAS in drinking water” among other water system.

The EPA has also been pursuing research into “PFAS destruction technology” and other possible mitigation measures amid mounting evidence of the pervasiveness of the PFAS compounds.

Politics

In November 2021 Michigan Democratic congresswoman Debbie Dingell introduced a bill in the U.S. House of Representatives proposing to ban PFAS in US food packaging and significantly reduce exposure to the highly toxic compounds. Similar legislation introduced in the last legislative session failed to pass.

PFAS manufacturers have actively lobbied against such laws on the chemicals. U.S. Sen. Jim Inhofe, who sits on the environmental committee and has opposed PFAS legislation, has received at least $60,000 from PFAS producers, according to The Guardian.

State actions

Many states have moved to investigate the extent of PFAS contamination, protect residents from PFAS exposures and to hold companies accountable for PFAS pollution. Here are a few recent actions:

Alabama – PFAS manufacturer 3M agreed to pay local government agencies in Alabama $98.4 million in October 2021 in a deal reached through court-ordered mediation over claims that one of the company’s chemical plants polluted the Tennessee River in northern Alabama. The money is to be used to fund cleanup efforts and reimburse water agencies prior efforts to remediate PFAS from the drinking water. 3M also agreed to pay $12 million to settle a potential class action lawsuit by Alabama drinking water customers.

California – In October 2021, the state enacted new laws that prohibit the use of PFAS in children’s products; ban the sale or distribution of any food packaging that contains PFAS after Jan. 1, 2023; and order that by Jan.1, 2024, labels on cookware must list any PFAS in the product and provide a link or QR code to a webpage that contains more details.

Maine – Maine environmental regulators said in October 2021 that they were launching a statewide investigation to identify PFAS contamination sites related to the state’s municipal sludge and paper mills. State lawmakers have earmarked $30 million to test for PFAS and to install filtration systems on contaminated water systems. The state also said it will assist farmers whose land or water is found to have unsafe levels of PFAS.

Michigan – In October 2021, Michigan Governor Gretchen Whitmer signed an executive directive telling the state to “use its purchasing power—an estimated $2.5 billion annually” to buy products that do not contain PFAS chemicals.

New Hampshire – The New Hampshire Department of Natural Resources said in November 2021 that PFAS contamination was so high in five of its lakes that people should limit fish consumption, particularly children.

North Carolina – In November 2021, North Carolina’s attorney general filed lawsuits against 14 manufacturers of a fire suppressant made with PFAS, asking the court to require the manufacturers to pay for investigations to determine the extent of the pollution damage and clean up the damage, replace water treatment systems and wells, and restore damaged natural resources, and monitor water quality going forward. The lawsuits focus on PFAS contamination at Charlotte-Douglas International Airport and at an Air National Guard Base.

Oregon – Oregon said in October 2021 it would test about 150 drinking water systems across the state to determine levels of PFAS contamination.

Pennsylvania- Pennsylvania regulators in November 2021 said they would set enforceable limits on toxic “forever chemicals” in drinking water. Specifically, Pennsylvania officials said they plan to set drinking water limits on the two best-studied of the chemicals, known as PFOA and PFOS.

News & Opinion

Two ‘forever chemicals’ more toxic than previously thought: EPA drafts, by Rachel Frazen, The Hill, Nov. 16, 2021.

North Carolina AG sues 14 companies over fire suppressant, Associated Press, Nov. 5, 2021. “Attorney General Josh Stein filed four lawsuits which named 3M, Corteva, and DuPont, among others. In the lawsuit, Stein is asking the court to require the manufacturers to pay for investigations to determine the extent of the damage, clean up the damage, replace water treatment systems and wells, restore damaged natural resources and to monitor water quality.”

Senator, clean water advocates ask for state action after troubling GenX toxicity report, by Johanna Still, Port City Daily, Oct. 31, 2021. “Chemours’ trademark unregulated chemical GenX is more toxic than previously understood, according to a final toxicity report released by the Environmental Protection Agency Monday. The EPA’s new lifetime chronic reference dose for GenX, calculated with the most vulnerable populations in mind, is 3 parts per trillion (ppt). Concentrations of the chemical ingested over a lifetime at or below this threshold are unlikely to lead to negative health effects in humans, the report concludes.”

Forever chemicals widespread in Mass. Surface and ground water, says new report, by Barbara Moran, WBUR, Oct. 29, 2021. “The new analysis of state data follows reports of PFAS contamination in Cape Cod ponds and many Massachusetts rivers, pointing to widespread contamination throughout state lakes, ponds, rivers and aquifers used as sources for drinking water.”

EPA finds chemical contaminating NC river more toxic than previously assessed, by Rachel Frazin, The Hill, Oct. 25, 2021.

Lethal ‘forever chemical’ taint our food, water and even blood. The EPA is stalling, by David Bond, The Guardian, Oct. 24, 2021. “There is no longer any population or place on earth untouched by PFAS contamination. We are living through a toxic experiment with no control group.”

How chemical companies avoid paying for pollution, by David Gelles and Emily Steel, The New York Times, Oct. 20, 2021. “To avoid responsibility for what many experts believe is a public health crisis, leading chemical companies like Chemours, DuPont and 3M have deployed a potent mix of tactics. They have used public charm offensives to persuade regulators and lawmakers to back off. They have engineered complex corporate transactions to shield themselves from legal liability. And they have rolled out a conveyor belt of scantly tested substitute chemicals that sometimes turn out to be just as dangerous as their predecessors.”

Bad Chemistry series of articles by Sharon Lerner, The Intercept, September 2015-ongoing. “The U.S. has refused to regulate the chemicals in this class, known as PFAS, despite the fact that they persist indefinitely in the environment and have been linked to cancer and many other illnesses.”

EPA unveils new strategy to address US contamination of ‘forever’ chemicals, by Carey Gillam, The Guardian, Oct. 18, 2021. “The US Environmental Protection Agency (EPA) on Monday announced a “strategic roadmap” it said would help restrict a class of toxic chemicals from being released into the environment and accelerate the cleanup of existing contamination of “forever chemicals” that are associated with a range of human health dangers.”

Revealed: More than 120,000 US sites feared to handle harmful PFAS ‘forever’ chemicals, by Carey Gillam, The Guardian, Oct. 17, 2021 “The US Environmental Protection Agency (EPA) has identified more than 120,000 locations around the US where people may be exposed to a class of toxic “forever chemicals” associated with various cancers and other health problems that is a frightening tally four times larger than previously reported, according to data obtained by the Guardian.”

Suppressed Study: The EPA underestimated dangers of widespread chemicals, by Abrahm Lustgarten, ProPublica, , June 20, 2018. “A major environmental health study that had been suppressed by the Trump administration because of the “public relations nightmare” it might cause the Pentagon and other polluters has been quietly released online.”

The lawyer who became DuPont’s worst nightmare, by Nathaniel Rich, The New York Times, Jan. 6, 2016. “Rob Bilott was a corporate defense attorney for eight years. Then he took on an environmental suit that would upend his entire career — and expose a brazen, decades-long history of chemical pollution.”

The Teflon toxin, three-part series of articles by Sharon Lerner, The Intercept, Aug. 11, 2015 – Aug. 20, 2015. “In this series, Sharon Lerner exposes DuPont’s multi-decade cover-up of the severe harms to health associated with a chemical known as PFOA, or C8, and associated compounds such as PFOS and GenX.”

The Teflon toxin goes to court, by Sharon Lerner, The Intercept, Sept. 19, 2015. “DuPont went to court this week, defending its use of C8, the chemical that spread from the company’s Parkersburg, West Virginia, plant into the drinking water of some 80,000 people in West Virginia and Ohio. A jury in Columbus, Ohio, is now hearing the case of Carla Bartlett, a 59-year-old woman who developed kidney cancer after drinking C8-contaminated water for more than a decade.”

Papers: DuPont hid chemical risk studies, by John Heilprin, Associated Press, Nov. 16, 2005. “DuPont Co. hid studies showing the risks of a Teflon-related chemical used to line candy wrappers, pizza boxes, microwave popcorn bags and hundreds of other food containers, according to internal company documents and a former employee.”

Statements

Zürich Statement on Future Actions on Per- and Polyfluoroalkyl Substances (PFASs), Environmental Health Perspectives, August 2018.

Comment on “Fluorotechnology Is Critical to Modern Life: The FluoroCouncil Counterpoint to the Madrid Statement,” Environmental Health Perspectives July 2015.

The Madrid Statement on Poly- and Perfluoroalkyl Substances (PFASs), Environmental Health Perspectives, May 2015.

Helsingør statement on poly- and perfluorinated alkyl substances (PFASs), Chemosphere, November 2014.

Research

Ulcerative colitis

PFOA and ulcerative colitis, Environmental Research, May 2018.

Ulcerative colitis and perfluorooctanoic acid (PFOA) in a highly exposed population of community residents and workers in the Mid-Ohio Valley, Environmental Health Perspectives, August 2013.

Exposure, water contamination issues, general

Evaluation and management strategies for per- and polyfluoroalkyl substances (PFASs) in drinking water aquifers: perspectives from impacted U.S. northeast communities, Environmental Health Perspectives, June 2018.

Half-lives of PFOS, PFHxS and PFOA after end of exposure to contaminated drinking water, Occupational and Environmental Medicine, November 2017.

Technical Report: Half-lives of PFOS, PFHxS and PFOA after end of exposure to contaminated drinking water, The Sahlgrenska Academy Institute Of Medicine, University of Gothenburg, 2017.

A cohort incidence study of workers exposed to perfluorooctanoic acid (PFOA), Occupational Environmental Medicine, May 2015.

Associations Between Serum Perfluoroalkyl Acids and LINE-1 DNA Methylation, Environment International, February 2014.

Cohort mortality study of workers exposed to perfluorooctanoic acid, American Journal of Epidemiology, November 2012.

Environmental fate and transport modeling for perfluorooctanoic acid emitted from the Washington Works Facility in West Virginia, Environment Science & Technology, January 2011.

Private drinking water wells as a source of exposure to PFOA in communities surrounding a fluoropolymer production facility, Environmental Health Perspectives, January 2011.

Biomarker-based calibration of retrospective exposure predictions of perfluorooctanoic acid, Environmental Science & Technology, May 2014.

Accumulation and clearance of PFOA in current and former residents of an exposed community, Environmental Health Perspectives, January 2011.

Epidemiologic evidence on the health effects of perfluorooctanoic acid (PFOA), Environmental Health Perspectives, August 2010.

The C8 Health Project: Design, methods, and participants, Environmental Health Perspectives, December 2009.

Other fact sheets and resources

Interstate Technology and Regulatory Council

Agency for Toxic Substances and Disease Registry

National Institute of Environmental Health Sciences

Centers for Disease Control and Prevention

Environmental Working Group

Great Lakes PFAS Policy Agenda.

Center for the Advancement of Public Action (CAPA) at Bennington College

Books and film

Exposure – Poisoned Water, Corporate Greed, and One Lawyer’s Twenty-Year Battle against DuPont, by Robert Bilott, Atria Books (July 14, 2020).

The Devil We Know documentary film

Dark Waters feature film

Cancer patient lawyer spars with Monsanto scientist in California Roundup trial

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Posted on September 22, 2021 by Carey Gillam

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.

Bayer seeks U.S. Supreme Court review of Roundup trial loss

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Posted on August 16, 2021 by Carey Gillam

Monsanto owner Bayer AG on Monday filed a petition with the U.S. Supreme Court, seeking the high court’s review of one of its trial losses in the nationwide Roundup cancer litigation.

The move is widely seen as Bayer’s best hope for putting an end to claims that exposure to Monsanto’s glyphosate-based herbicides, such as the popular Roundup brand, cause non-Hodgkin lymphoma, and the company failed to warn users of the risks. The company has thus far lost three out of three trials, and there are currently more than 100,000 existing plaintiffs as well as many more potential future plaintiffs expected to bring similar claims. Bayer has been trying to settle the cases and come up with a plan to limit, block or settle future claims.

Bayer’s writ of certiorari asks the court to review the Ninth Circuit Court of Appeals’ decision in the case of Hardeman v. Monsanto.

During the month-long trial in 2019, lawyers for plaintiff Edwin Hardeman presented jurors with a range of scientific research showing cancer connections to Monsanto’s herbicides as well as evidence of many Monsanto strategies aimed at suppressing the scientific information about the risks of its products. Internal Monsanto documents showed the company’s scientists had engaged in secretly ghost-writing scientific papers that the company then used to help convince regulators of product safety.

The plaintiffs’ attorneys argued that Monsanto should have warned consumers about the risks that its products could cause cancer. Lawyers in the other trials Monsanto lost presented similar arguments and evidence of cancer risk.

FIFRA fight

Bayer has said it hopes the Supreme Court will agree with Bayer’s position that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the registration, distribution, sale, and use of pesticides in the United States, preempts those “failure-to-warn” claims that are central to the Roundup lawsuits. Because the Environmental Protection Agency (EPA) has approved labels with no cancer warning, the failure-to-warn claims should be barred, the company maintains.

The petition filed Monday urges the Supreme Court to review the Ninth Circuit Court of Appeals’ decision upholding the Hardeman trial loss on the grounds that FIFRA preempts a state-law failure to-warn claim “where the warning cannot be added to a product without EPA approval and EPA has repeatedly concluded that the warning is not appropriate.”

The petition also asks the court to address whether or not the Ninth Circuit’s standard for admitting expert testimony “is inconsistent with this Court’s precedent and Federal Rule of Evidence 702.” Bayer argues that the admission of expert testimony in the Hardeman case “departed from federal standards, enabling plaintiff’s causation witnesses to provide unsupported testimony on the principal issue in the case, Roundup’s safety profile.”

In its petition, Bayer argues: “The Ninth Circuit’s errors mean that a company can be severely punished for marketing a product without a cancer warning when the near-universal scientific and regulatory consensus is that the product does not cause cancer, and the responsible federal agency has forbidden such a warning.”

Hardeman lawyer Aimee Wagstaff said her legal team had been preparing for Bayer’s bid for Supreme Court review.

“While paying out billions of dollars to settle claims, Monsanto continues to refuse to pay Mr. Hardeman’s verdict. That doesn’t seem fair to Mr. Hardeman. Even so, this is Monsanto’s last chance Hail Mary,” Wagstaff said. “We are eager and ready to beat Monsanto at the Supreme Court and put this baseless preemption defense behind us once and for all.”

Bayer cites broad impact

The petition states that the decision in the Hardeman case, which was part of the multidistrict litigation handled in federal court, will “undoubtedly influence still others pending across the country.”

Bayer said in a statement: “The Petition underscores that consistent regulatory assessments in the U.S. and worldwide, and the overwhelming weight of scientific evidence, support the conclusion that glyphosate-based herbicides are safe and not carcinogenic. In light of the EPA’s approval of the Roundup label without a cancer warning, any state-law failure-to-warn claims premised on such warning would plainly conflict with federal law and thus are preempted. Courts across the U.S. have divided on this basic question of when federal law preempts state law, which makes review by the U.S. Supreme Court both important and necessary. Indeed, it has been 16 years since the Supreme Court ruled on FIFRA preemption, and the prior case did not involve a warning that EPA had rejected.”

Lawyers for Hardeman did not respond to a request for comment.

Bayer has so far said it has earmarked more than $16 billion toward settling the Roundup litigation.

Trial pitting farmers against Syngenta delayed until June

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Posted on May 8, 2021 by Carey Gillam

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

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

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

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

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

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

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

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

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

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

Move to consolidate U.S. paraquat litigation as cases mount against Syngenta

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Posted on April 9, 2021 by Carey Gillam

Lawyers suing Swiss chemical company Syngenta are asking a U.S. judicial panel to consolidate more than a dozen similar lawsuits under the oversight of a federal judge in California. The move is a telling sign of the expansion of litigation that alleges the company’s weed killing products cause Parkinson’s Disease.

According to the motion, filed April 7 by the Texas-based Fears Nachawati law firm with the U.S. Judicial Panel on Multidistrict Litigation, there are currently at least 14 lawsuits filed by eight different law firms in six different federal courts across the country. The lawsuits are all filed on behalf of plaintiffs who have been diagnosed with the neurodegenerative disorder, and they allege exposure to Syngenta’s weed killers made with a chemical called paraquat for the disease. Several other cases making the same allegations are pending in state courts.

“The cases are excellent candidates for coordinated pretrial proceedings because they arise from the same poisonous toxin causing the same crippling disease resulting from the wrongful conduct of the same three defendants,” the Fears Nachawati brief in support of its motion states. “Movant expects that the number of similar cases filed in state and federal courts across the country will expand rapidly.”

The motion seeks transfer specifically to Judge Edward Chen in the U.S. District Court for the Northern District of California.

Majed Nachawati, a partner with the Fears Nachawati firm, said the firm was still investigating the size and scope of the overall litigation but believes the paraquat litigation against Syngenta “will be significant and material in nature…”

“Very soon, there is going to be litigation in dozens of federal courts across the country,” Nachawati said.

The plaintiffs’ lawyers will be seeking internal corporate documents as well as depositions of corporate officials related to the “testing, design, labeling, marketing, and safety of paraquat herbicides,” along with corporate research and evaluations of the toxicity and safety of its paraquat products.

The Miller Firm of Virginia, which helped lead the Roundup cancer litigation against Monsanto that resulted in an $11 billion settlement with Monsanto owner Bayer AG, is among the law firms joining in the paraquat litigation. The Miller firm supports the effort to consolidate the federal actions in California, where thousands of Roundup cases were also consolidated for pretrial proceedings, according to the firm’s lead attorney Mike Miller.

“We are confident that science strongly supports the causal connection between paraquat and the devastation of Parkinson’s disease,” Miller said of the motion. “The Northern District of California is well equipped to handle these cases.”

The cases against Syngenta also name Chevron Phillips Chemical Co. as a defendant. Chevron distributed and sold Gramoxone paraquat products in the United States starting with 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 manufacture, use, and sell paraquat formulations in the U.S.

Syngenta and Chevron have denied the allegations.

Syngenta says that its paraquat products have been approved as “safe and effective” for more than 50 years and it will “vigorously” defend the lawsuits. Syngenta is owned by China National Chemical Corporation, known as ChemChina.

Scientific studies

Parkinson’s is an incurable progressive disorder that affects nerve cells in the brain, leading in advanced cases to severe physical debilitation and often dementia. Many Parkinson’s experts say the disease can be caused by a range of factors, including exposure to pesticides such as paraquat, as well as other chemicals.

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. That 2011 research reported that people who used paraquat were twice as likely to develop Parkinson’s disease as people who did not use it.

“Numerous epidemiological and animal studies have linked paraquat to Parkinson’s disease,” said Ray Dorsey, a professor of neurology and director of the Center for Human Experimental Therapeutics at University of Rochester in New York. Dorsey is also the author of a book about prevention and treatment of Parkinson’s Disease.

“The evidence linking paraquat to Parkinson’s disease is probably the strongest of any pesticide commonly used,” he said.

Some studies have not found any clear links between paraquat and Parkinson’s and Syngenta asserts that the most recent and authoritative research does not show a connection.

Indeed, a study published in 2020 found connections between some other pesticides and Parkinson’s, but no strong evidence showing paraquat causes the disease.

Upcoming trial

One case filed in a state court is scheduled to go to trial next month. Hoffman V. Syngenta is slated for trial May 10 in St. Clair County Circuit Court in Illinois. A status conference is scheduled for the end of this month.

Missouri lawyer Steve Tillery, who is representing the plaintiffs in the Hoffman case as well as several other plaintiffs in other paraquat lawsuits, said despite Syngenta’s assertions to the contrary, he has accumulated evidence that includes internal company records showing Syngenta has known for decades that its product causes Parkinson’s Disease.

“They shouldn’t be selling this product, said Tillery. “This chemical should be off the market.”

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

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Posted on November 23, 2020 by Carey Gillam

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.

Appeals court upholds groundskeeper’s Roundup cancer trial win over Monsanto

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Posted on July 20, 2020 by Carey Gillam

In yet another court loss for Monsanto owner Bayer AG, an appeals court rejected the company’s effort to overturn the trial victory notched by a California school groundskeeper who alleged exposure to Monsanto’s glyphosate herbicides caused him to develop cancer, though the court did say damages should be cut to $20.5 million.

The Court of Appeal for the First Appellate District of California said Monday that Monsanto’s arguments were unpersuasive and Dewayne “Lee” Johnson was entitled to collect $10.25 million in compensatory damages and another $10.25 million in punitive damages. That is down from a total of $78 million the trial judge allowed.

“In our view, Johnson presented abundant—and certainly substantial— evidence that glyphosate, together with the other ingredients in Roundup products, caused his cancer,” the court stated. “Expert after expert provided evidence both that Roundup products are capable of causing non-Hodgkin’s lymphoma… and caused Johnson’s cancer in particular.”

The court further noted that “there was overwhelming evidence that Johnson has suffered, and will continue to suffer for the rest of his life, significant pain and suffering.”

The court said that Monsanto’s argument that scientific findings about glyphosate’s links to cancer constituted a “minority view” was not supported.

Notably, the appeals court added that punitive damages were in order because there was sufficient evidence that Monsanto acted with “willful and conscious disregard of others’ safety.”

Mike Miller, whose Virginia law firm represented Johnson at trial along with the Baum Hedlund Aristei & Goldman firm of Los Angeles, said he was cheered at the court’s confirmation that Johnson developed cancer from his use of Roundup and that the court affirmed the award of punitive damages for “Monsanto’s willful misconduct.”

“Mr Johnson continues to suffer from his injuries. We are proud to fight for Mr Johnson and his pursuit of justice,” Miller said.

Monsanto owes annual interest at the rate of 10 percent from April of 2018 until it pays the final judgment.

The reduction in damages is tied in part to the fact that doctors have told Johnson his cancer is terminal and he is not expected to live very much longer. The court agreed with Monsanto that because compensatory damages are designed to compensate for future pain, mental suffering, loss of enjoyment of life, physical impairment, etc… Johnson’s short life expectancy legally means the future “non-economic” damages awarded by the trial court must be reduced.

Brent Wisner, one of Johnson’s trial attorneys, said the reduction in damages was the result of a “deep flaw in California tort law.”

“Basically, California law does not allow a plaintiff to recover for a shortened life expectancy,” Wisner said. “This effectively rewards a defendant for killing a plaintiff, as opposed to just injuring him. It is madness.”

A spotlight on Monsanto’s conduct

It was just two months after Bayer bought Monsanto, in August 2018, that a unanimous jury awarded Johnson $289 million, including $250 million in punitive damages, finding that not only did Monsanto’s herbicides cause Johnson to develop non-Hodgkin lymphoma, but that the company knew of the cancer risks and failed to warn Johnson. The lawsuit involved two Monsanto glyphosate herbicide products – Roundup and Ranger Pro.

The trial judge lowered the total verdict to $78 million but Monsanto appealed the reduced amount. Johnson cross appealed to reinstate the $289 million verdict.

The Johnson trial was covered by media outlets around the world and put a spotlight on questionable Monsanto conduct. Lawyers for Johnson presented jurors with internal company emails and other records showing Monsanto scientists discussing ghostwriting scientific papers to try to shore up support for the safety of the company’s products, along with communications detailing plans to discredit critics, and to quash a government evaluation of the toxicity of glyphosate, the key chemical in Monsanto’s products.

Internal documents also showed that Monsanto expected the International Agency for Research on Cancer would classify glyphosate as a probable or possible human carcinogen in March of 2015 (the classification was as a probable carcinogen) and worked out a plan in advance to discredit the cancer scientists after they issued their classification.

Tens of thousands of plaintiffs have filed lawsuits against Monsanto making claims similar to Johnson’s, and two additional trials have taken place since the Johnson trial. Both those trials also resulted in large verdicts against Monsanto. Both are also under appeal.

In June, Bayer said it had reached a settlement agreement with attorneys representing 75 percent of the roughly 125,000 filed and yet-to-be filed claims initiated by U.S. plaintiffs who blame exposure to Monsanto’s Roundup for their development of non-Hodgkin lymphoma. Bayer said it will provide $8.8 billion to $9.6 billion to resolve the litigation. But lawyers representing more than 20,000 additional plaintiffs say they have not agreed to settle with Bayer and those lawsuits are expected to continue to work their way through the court system.

In a statement issued after the court ruling, Bayer said it stands behind the safety of Roundup: “The appeal court’s decision to reduce the compensatory and punitive damages is a step in the right direction, but we continue to believe that the jury’s verdict and damage awards are inconsistent with the evidence at trial and the law. Monsanto will consider its legal options, including filing an appeal with the Supreme Court of California.”

Attorney for Roundup Cancer Plaintiffs Arrested on Criminal Charges

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Posted on December 18, 2019 by Carey Gillam

The legal drama surrounding the mass tort Roundup cancer litigation just got ratcheted up a notch.

Federal criminal charges were filed this week against attorney Timothy Litzenburg alleging the 37-year-old lawyer demanded $200 million in “consulting fees” in exchange for keeping quiet about information that he threatened would be potentially devastating to a chemical compound supplier to Monsanto.

Litzenburg was charged with one count each of attempted extortion, conspiracy and transmission of interstate communications with intent to extort. He was arrested Tuesday but has been released on bond.

Litzenburg was the attorney for Dewayne “Lee” Johnson leading up to Johnson’s 2018 trial against Monsanto, which resulted in a $289 million jury award in Johnson’s favor. The trial was the first of three that have taken place against Monsanto over allegations that the company’s glyphosate-based herbicides such as Roundup cause non-Hodgkin lymphoma. Monsanto, and its German owner Bayer AG, have lost all three trials to date but are appealing the verdicts.

Though Litzenburg had been responsible for preparing Johnson for trial, he was not allowed to participate during the actual event because of concerns about his behavior held by The Miller Firm, which was his employer at the time.

The Miller firm subsequently fired Litzenburg and filed a lawsuit alleging Litzenburg engaged in self-dealing, and “disloyal and erratic conduct.” Litzenburg responded with a counter-claim. The parties recently negotiated a confidential settlement.

The new trouble for Litzenburg came in the form of a criminal complaint filed Monday in federal court in Virginia. The complaint does not name the company Litzenburg was demanding money from, referring to it as “Company 1.” According to the charges, Litzenburg contacted Company 1 in September of this year stating that he was preparing a lawsuit that would allege Company 1 and related companies supplied chemical compounds used by Monsanto to create its branded Roundup herbicide and that Company 1 knew the ingredients were carcinogenic but had failed to warn the public. He also attempted to involve an entity referred to in the complaint as Company 2, described by prosecutors as a U.S. publicly traded company that bought Company 1 in 2018.

Earlier this year Litzenburg told US Right to Know that he was drafting such a complaint against chemical supplier Huntsman International and related entities, but it is not clear if Huntsman is involved in this action.

Litzenburg, who is now a partner with the firm of Kincheloe, Litzenburg & Pendleton, did not respond to a request for comment. Neither did his law partner Dan Kincheloe. Litzenburg has claimed to be representing roughly 1,000 clients suing Monsanto over Roundup cancer causation allegations.

According to the complaint, Litzenburg told a lawyer for Company 1 that he believed if he filed an initial lawsuit many more would follow. To prevent that, Company 1 could enter into a “consulting arrangement” with Litzenburg, the lawyer allegedly told the company. As a consultant Litzenburg would have a conflict of interest that would prevent him from filing the threatened litigation.

According to information the complaint states was provided by an attorney for Company 1, Litzenburg said he would need a $5 million settlement of the drafted lawsuit and a consulting arrangement for $200 million for himself and an associate. The criminal complaint states that Litzenburg put the terms of his demand in writing in an email to the company attorney, warning that if the company did not comply, Litzenburg would create “Roundup Two,” which would cause “an ongoing and exponentially growing problem” for Company 1.

Litzenburg wrote in the email that the $200 million consulting agreement for himself and an associate was “a very reasonable price,” according to the criminal complaint. At least two such “associates” were involved in the scheme, according to the complaint.

The attorney for Company 1 contacted the U.S. Department of Justice in October and investigators subsequently recorded a phone call with Litzenburg discussing the $200 million he was seeking, the complaint states.

According to the complaint, Litzenburg was recorded as saying: “The way that I guess you guys will think about it and we’ve thought about it too is savings for your side. I don’t think if this gets filed and turns into mass tort, even if you guys win cases and drive value down… I don’t think there’s any way you get out of it for less than a billion dollars. And so, you know, to me, uh, this is a fire sale price that you guys should consider…”

During other communications with Company 1, Litzenburg allegedly said that if he received the $200 million, he was willing to “take a dive” during a civil deposition of a Company 1 toxicologist to undermine the prospects for future plaintiffs to try to sue the company.

If Company 1 entered into a deal with him, Litzenburg allegedly said, it would mean Company 1 would “avoid the parade of horribles that has been the Roundup litigation for Bayer/Monsanto.”

Prosecuting the case for the U.S. Department of Justice are Assistant Chief L. Rush Atkinson and Principal Assistant Chief Henry P. Van Dyck of the Criminal Division’s Fraud Section.

See the Email Trail Showing Influence Peddling by Press Association to Bayer

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Posted on November 22, 2019 by Carey Gillam

Journalists around the globe have reacted with outrage to revelations published in The Guardian this week that show Thanos Dimadis, the former executive director of the Foreign Press Foundation, offered an unusual arrangement to Bayer AG that called for using the press organization, which is dedicated to protecting a free press, in ways that would also protect and benefit Bayer’s business interests. In exchange for the influence and access into the press association, Bayer agreed to provide generous funding, the emails show, including extra money for Dimadis personally.

Dimadis has recently become president of a new organization called the Association of Foreign Correspondents in the USA (AFC-USA), which is primarily funded by Bayer, the German pharmaceutical and chemical giant that last year bought Monsanto Co.

Monsanto was mired in litigation over allegations its Roundup herbicide causes cancer when Bayer bought the company in June 2018. Three trial losses since the acquisition have worried Bayer investors and left Bayer to defend against Monsanto’s documented history of trying to manipulate media, scientists and regulators to benefit its own interests.

Bayer officials assert Bayer is dedicated to truth and transparency and supports a free press. The company denies it sought or received any undue influence within the Foreign Press Association or the new Association of Foreign Correspondents.

Here is a list of several of the emails:

Details of arrangement with Bayer

List of journalists for Bayer to select for engagement

Dimadis asks Bayer’s direction for press association “to strategize properly”

Dimadis asks for extra money for himself from Bayer

Bayer appreciates Dimadis’ actions and agrees to add money to the budget for Dimadis

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Introduced in 1974

Glyphosate in urine

A spotlight on Monsanto’s conduct