Nearly 60 of these claims are currently pending in the US District Court for the Northern District of California, a federal court in San Francisco where the cases have been consolidated under the guidance of Judge Vince Chhabria.
In San Francisco, the claims against Monsanto will progress through pre-trial proceedings as a group, allowing plaintiffs’ attorneys to coordinate their efforts in pursuit of justice. Elsewhere, several hundred Roundup claims are currently making their way through pre-trial proceedings in a Missouri state court in St. Louis, where Monsanto maintains its US headquarters. An additional 30 to 40 lawsuits are pending in a state court in Delaware, the state in which Monsanto was incorporated.
Despite being scattered across a number of federal and state courts, legal observers say that the growing Monsanto litigation is progressing at a rapid pace. In California, Judge Chhabria has already set key court dates, with the end of discovery, the evidence-gathering stage in a lawsuit, set to end on April 17, 2017. By May 1, plaintiffs and Monsanto are expected to submit their medical expert reports. Daubert hearings, in which the parties can question the credibility of expert witnesses, are scheduled for October 13.
EPA Downgrades Glyphosate As Cancer Risk
Like the FDA’s regulation of pharmaceutical drugs, the Environmental Protection Agency exerts significant control over the pesticide industry, approving sales of only those herbicides that scientific studies have found do not pose unreasonable risks to people or the environment.
At one point, the EPA considered glyphosate to have significant potential risks for human health. In fact, researchers at the Environmental Protection Agency had originally classified glyphosate as a Group C agent – “possibly carcinogenic to humans” – as early as 1985. That’s when Monsanto’s lobbyists ramped up their efforts, plaintiffs say. The company’s vast network of influencers went to work, flooding EPA officials with studies, often funded by Monsanto itself, that appeared to show exposure to glyphosate in a softer light.
After six years, the EPA folded, patients claim, downgrading the herbicide to Group E, where substances with “evidence of non-carcinogenicity in humans” are relegated. Monsanto hadn’t just convinced government regulators that glyphosate didn’t cause cancer. The company had managed an even greater task, according to lawsuits, by convincing the EPA that glyphosate was safe.
How Does Roundup Work?
In reality, Monsanto had been under fire for decades over glyphosate, the active ingredient in the company’s flagship Roundup herbicide. Glyphosate was designed and introduced to the market by Monsanto in 1974. When Monsanto introduced Roundup to the US market, the corporation kicked off an agricultural revolution, starting a trend that has now become ubiquitous under the banner of genetically modified organisms, or GMOs.
Roundup is a designer herbicide, comprised of three ingredients:
- glyphosate – active ingredient – inhibits plant growth, starving weeds for nutrition
- surfactant – reduce surface tension of water droplets, allowing glyphosate to penetrate plant layers
Each of these three ingredients is critical to the weed-killing effects of Roundup. While glyphosate does most of the work, a surfactant is necessary to get glyphosate inside plants in the first place, Penn State University says. To decrease the surface tension of sprayed Roundup, Monsanto used to rely on a surfactant known as polyethoxylated tallow amine, or POEA. In recent years, the company has informed customers that it will be moving away from POEA and other similar ingredients.
Why? The move was a strategic one: POEA has now been banned in the European Union, after researchers found significant evidence of the chemical’s toxicity in humans. While Monsanto continues to maintain that POEA does not “pose an imminent risk for human health,” plaintiffs in Roundup lawsuits disagree. In fact, hundreds of patients contend that both glyphosate and surfactant can cause non-Hodgkin’s lymphoma. Put the ingredients together, the claims continue, and Roundup becomes particularly deadly.
Ubiquitous Weedkiller In Food, Water, Air
Despite long-standing concerns over the chemical’s safety, glyphosate is everywhere. The chemical has seeped into our food and water supplies. In 2011, researchers at the US Geological Survey detected substantial levels of glyphosate in rivers, rain and air moisture in agricultural areas.
Scientists from Norway have confirmed that genetically-modified soybeans retain “high residues of glyphosate,” allowing the chemical to circulate freely on the open market and ultimately reach our plates. Glyphosate has been found in the urine of both agricultural workers and people living in urban areas who have never been directly exposed to the chemical. The understanding that glyphosate has reached our supermarkets and drinking water supplies is widespread.
IARC: Glyphosate “Probably Carcinogenic To Humans”
This research has been growing for decades, but a report issued in 2015 finally broke the story of Roundup’s link to cancer on the global stage.
In March of 2015, the International Agency for Research on Cancer (IARC) released a formal monograph, presenting the group’s analysis of the numerous studies conducted on glyphosate’s potential risks. The IARC, an arm of the World Health Organization, is widely-considered the world’s premier cancer research institute. Alongside basic investigations, the agency’s primary role is to review scientific studies and identify new carcinogens. IARC determinations are frequently referred to as the “gold standard in evaluating evidence on cancer causation,” writes Suzanne H. Reuben of Progressive Health Systems, a long-time writer for the President’s Cancer Panel.
Group 2A Classification
When it comes to identifying carcinogens, the International Agency for Research on Cancer wrote the rules. That’s why the determination announced on March 20, 2015 sent shockwaves around the world. Authored by a working group of 17 cancer experts who had been sequestered in Lyons, France, the IARC’s first monograph listed glyphosate, the active ingredient in Roundup, as a Group 2A chemical:
- Group 2A – probably carcinogenic to humans
- “there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals”
Only 81 other agents have been classified under Group 2A since the IARC began making its determinations in the 1970’s.
Monsanto Strikes Out Against Cancer Experts
All this scared Monsanto, for very obvious reasons. With profits in the billions of dollars, Roundup was – very literally – the company’s cash cow.
Only three days after IARC released its first monograph on glyphosate, the company’s lobbyists were already calling officials at the Environmental Protection Agency, pleading with them to “correct the record.” Monsanto’s lead on regulatory affairs, Dan Jenkins, shot an email to Michael Goodis, asking the Pesticide Registration Division Director to “correct mistakes or absences of fact” that could alter public opinion on the company’s top-selling herbicide.
IARC Targeted By Agrochemical Giant
Meanwhile, Monsanto went on the offensive, in what plaintiffs say was an attack on the credibility of the world’s premier cancer research organization. In court filings, Monsanto’s attorneys denounced the International Agency for Research on Cancer directly, calling the scientific outfit an “unelected, undemocratic, unaccountable, and foreign body.”
In an attempt to comb through the glyphosate working group’s proceedings, Monsanto subpoenaed the emails of Aaron Blair, the well-regarded National Cancer Institute researcher who chaired the IARC’s committee. In an even stranger twist, Congress’ Committee on Oversight and Government Reform petitioned the National Institutes of Health to question the government’s financial support for IARC. In a letter dated September 26, 2016, Arizona State Representative Jason Chaffetz expressed his doubts over the International Agency for Research on Cancer’s pedigree, parroting many of the same arguments made by Monsanto.
In the eyes of many researchers, it’s not IARC we should be questioning. It’s the EPA. Christopher Portier, a former Director at the US Centers for Disease Control and Prevention, was unequivocal in a recent interview with the Huffington Post: “[glyphosate] is a probable human carcinogen by any reasonable definition. It is nonsense to say otherwise.” The Environmental Protection Agency tells a different story, one that appears to be closely-aligned with the narrative offered by Monsanto and other agrochemical corporations.
Second IARC Monograph Outlines Lymphoma Link
IARC, however, was not deterred by the controversy. On July 29, 2015, the organization released its full monograph on glyphosate, outlining the agency’s position over nearly 80 pages of scientific data.
As before, researchers had categorized the chemical in Group 2A, based on a number of studies that had found abnormally high rates of non-Hodgkin’s lymphoma in workers exposed to glyphosate, including a more than doubling in the risk for subtypes of lymphoma like multiple myeloma. The researchers drew their conclusion from studies that involved a wide array of agricultural workers, including:
- farmers and tree nursery workers in the US
- forestry workers in Canada and Finland
- municipal weed-control workers in the UK
Animal studies had also hit on troubling results, with rare tumors developing at an accelerated rate in mice exposed to the chemical. The IARC’s conclusion was simple:
“Glyphosate is probably carcinogenic to humans […] In addition to limited evidence for the carcinogenicity of glyphosate in humans and sufficient evidence for the carcinogenicity of glyphosate in experimental animals, there is strong evidence that glyphosate can operate through two key characteristics of known human carcinogens, and that these can be operative in humans.”
With the International Agency for Research on Cancer’s opinion now in full view of the public, Monsanto’s position had gone from bad to worse.
World Reacts Quickly To Roundup Cancer Risk
IARC determinations are taken extremely seriously. In California, a state law known as Proposition 65 forces manufacturers to place warning labels on products that contain carcinogens or teratogens, chemicals that can cause birth defects. When the IARC determines that a substance should be classified in Group 2A, Proposition 65 kicks in automatically. IARC classification also triggers action in the federal government, prompting increased workplace safety standards.
International health regulators also take note. After glyphosate was first labeled a probable carcinogen, France’s Ecology Ministry moved quickly, Newsweek reports, restricting Roundup sales in garden centers. Bermuda suspended imports of Roundup entirely. Sri Lanka’s Prime Minister placed an immediate ban on glyphosate-based herbicides in both commercial and private use. Columbia announced that it would stop using Roundup and other glyphosate-containing herbicides to eliminate unlawful coca plantations.
European Union Battles Over Glyphosate Authorization
The international response was swift and unambiguous. Meanwhile, regulators in the United States and Europe were locked in a battle over whether to reauthorize glyphosate sales.
The Environmental Protection Agency regularly re-evaluates the safety of herbicides every 15 years, allowing the agency’s authorizations to keep up with emerging medical research. The European Union’s Food Safety Authority (EFSA) uses a similar scheme, approving herbicides for general sale and then allowing member nations to make their own decisions based on the agency’s safety determinations.
Both governmental organizations were set to reassess the safety of glyphosate in 2016, but those plans were shaken up by the release of the International Agency for Research on Cancer’s findings.
European Food Safety Authority Review “Flawed”
Even more controversial was the publication of a report from the European Food Safety Authority on November 12, 2015, which baldly contradicted the conclusions reached by IARC. Glyphosate is “unlikely to be genotoxic (i.e. damaging to DNA) or to pose a carcinogenic threat to humans,” the EFSA wrote. Sparking waves of confusion and anger in the scientific community, Europe’s primary food supply watchdog asked officials at the European Commission to disregard IARC’s report.
Soon, many of Europe’s most distinguished scientists had fired their own shot in the debate. In a letter to EU Commissioner of Health and Food Safety Vytenis Andriukaitis, 96 epidemiologists and cancer experts asked the official to ignore the EFSA’s “flawed” report, which had questioned the link between glyphosate and cancer. How could two well-regarded health organizations come to such different opinions on the safety of glyphosate? Noting that six of the studies reviewed by the Food Safety Authority had been funded and submitted by chemical manufacturers, the European scientists suggested that industry pressure may have swayed the EFSA’s opinion:
“We reviewed these two differing decisions on the human carcinogenicity of glyphosate and conclude that the IARC […] decision is by far the more credible. The IARC […] decision was reached relying on open and transparent procedures by independent scientists who completed thorough conflict-of-interest statements and were not affiliated or financially supported in any way by the chemical manufacturing industry. It is fully referenced and depends entirely on reports published in the open, peer-reviewed biomedical literature.
In contrast, the [Food Safety Authority] decision is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner.”
The debate over glyphosate had become bitter – and protracted. Subsequent events would see the controversy around Roundup sail further into uncharted waters, with leaked EPA documents prompting allegations of collusion between the federal regulatory agency and the world’s largest agrochemical manufacturer.
Leaked EPA Documents Say Cancer Link “Not Likely”
Europe’s Food Safety Authority was not the only governmental agency to release a report contradicting the International Agency for Research on Cancer’s classification of glyphosate as a probable carcinogen. In May of 2016, an unapproved review of the chemical’s safety mysteriously appeared on the Environmental Protection Agency’s website.
The document spanned 87 pages, but its effect on the debate around glyphosate could have been guessed from just 7 words nestled in the report’s executive summary: “not likely to be carcinogenic in humans.” Almost as soon as the review had been released, it disappeared. The EPA removed the report within three days, telling reporters at Reuters that the “preliminary” assessment had been published “inadvertently.” Despite these assurances, Monsanto quickly pounced on the EPA’s apparent findings, which seemed to contradict the IARC’s position.
Regulators Stall Decisions On Weedkiller
Today, the European Union has yet to finalize an approval or denial for sales of Roundup in member states. The approval was harshly opposed by four member nations – Italy, France, Sweden and the Netherlands – which forced the vote to be rescheduled. With no hope of a resolution anytime soon, the European Commission interceded, extending glyphosate’s approval for another 18 months, according to Science. The vote is now slated for December 2017.
Likewise, regulators at the Environmental Protection Agency have stalled for years, repeatedly delaying a decision on glyphosate’s safety.
Glyphosate “Authoritatively Classified” As Carcinogen
In light of these setbacks, serious concerns within the scientific community have only grown. In February of 2016, the journal Environmental Health published a “consensus statement” on the cancer risks of glyphosate-based herbicide (GBH). The paper, written by 14 preeminent environmental scientists and genetics researchers, expressed a unified Statement of Concern on the rising use of GBH worldwide. Considering a wide range of published research, the scientists came to 7 notable conclusions:
- GBHs are the most heavily applied herbicide in the world and usage continues to rise
- Worldwide, GBHs often contaminate drinking water sources, precipitation, and air, especially in agricultural regions
- The half-life of glyphosate in water and soil is longer than previously recognized
- Glyphosate and its metabolites are widely present in the global soybean supply
- Human exposures to GBHs are rising
- Glyphosate is now authoritatively classified as a probable human carcinogen
- Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science
Keying in on an important problem, the researchers noted that government health regulators often disregard “published research” because the standards and procedures used in peer-reviewed publications can be “different from those codified in regulatory agency data requirements.” The IARC, for example, bases its determinations on higher scientific standards than are used in the reviews performed by the Environmental Protection Agency.
Controversy Threatens Monsanto’s $16 Billion Baby
Glyphosate-based herbicides aren’t Monsanto’s biggest source of revenue, but the chemical cocktails are crucial to the company’s profits. Roundup is a designer weedkiller, cooked up in Monsanto’s laboratories and quickly patented. But the product is only one part of Monsanto’s business strategy.
To unlock the potential of glyphosate, Monsanto needs to sell a special brand of seeds that can withstand the weed-killing power promised by Roundup. These “Roundup Ready” seeds thrive, even after being covered with glyphosate, because they were artificially designed to do just that.
With Roundup in hand and Roundup Ready seeds in the ground, farmers, landscapers, nurseries and home gardeners can forget about the weeds that could quickly starve their desired crops for nutrition and space.
Weed Resistance Drives Increased Herbicide Use
Roundup Ready Seeds are where the real money is, the Motley Fool reports. Analyzing Security & Exchange Commission filings for the financial year ending August 2015, reporters found that Monsanto had raked in more than $4.75 billion in revenue for sales of herbicide products.
That might sound like a lot – until you look at seed sales. In the same year, Monsanto’s revenue for selling Roundup Ready seeds and licensing the genetic code that creates glyphosate-resistant seeds soared to nearly $10.25 billion.
Weeds are hardy, though. After repeated exposure to glyphosate-containing herbicides, successive generations of an invasive plant ultimately develop a resistance to the once-deadly chemicals. Farmers don’t have to just keep buying Roundup; they have to keep buying more and more of the stuff, in order to keep with an evolving enemy. At the same time, Roundup has largely supplanted other herbicides on the marketplace, leading to trends that become clear after even a cursory look at US Department of Agriculture statistics. While America’s overall usage of herbicide has declined by nearly 22% since 1990, the usage of glyphosate has more than doubled.
Monsanto Sparks Backlash Among Farmers
As a result, yields have grown and farmers have been able to cut down on other herbicides that are, arguably, more harmful to the environment. Many agricultural workers, however, say that Monsanto’s business practices are unnecessarily harsh. Farmers, for example, can be severely disadvantaged by signing the labyrinthine contracts that Monsanto requires before the purchase of genetically-modified seeds. The company prohibits every one of its customers from saving or reusing seeds developed by GMO crops, locking growers into a constant cycle of annual purchases.
Monsanto even inspects fields to make sure no one’s cheating. If inspections don’t turn up evidence of patent infringement, there’s always the company’s toll-free snitch line, where farmers are encouraged to report unauthorized seed usage. Even more invasive enforcement strategies have been reported. The Canadian Broadcasting Corporation has a story on the Kram family of Raymore, Saskatchewan, who say that Monsanto agents dropped herbicide on their canola field, without permission, to see if the crops were resistant to glyphosate.
Legal options can also be limited, as many contracts with seed companies contain a binding arbitration clause that automatically forfeits a customer’s right to file a lawsuit. More often than not, Monsanto is the one suing farmers, not the other way around. In 2004, for example, the company filed suit against Percy Schmeiser, a family farmer in Saskatchewan, over genetically-modified canola seeds that had blown inadvertently onto Schmeiser’s land.
Monsanto’s Relationship With EPA “Highly Suspicious”
Monsanto’s lobbying dollars have reached the highest echelons of American politics. During her tenure as Secretary of State, Hillary Clinton helped the corporation expand into international markets, according to a report in the New York Daily News. After analyzing hundreds of diplomatic cables, public safety advocates at the non-profit Food & Water Watch discovered evidence that high-level officials in the State Department had intervened on Monsanto’s behalf in numerous countries, managing patent and intellectual property issues while quashing international criticism of GM seeds.
In a 2014 keynote address for the Biotechnology International Institute, a major Monsanto lobbying group, Clinton coached the lobbyists on how to change the “vocabulary” for genetically-modified products and avoid raising “red flag[s]” in public relations. Clinton was paid $335,000 for her remarks and, as HealthLine reported in August of 2016, Monsanto has donated up to $1 million to the Clinton Foundation. President Donald Trump owns around $50,000 of Monsanto stock.
EPA Official Served As Shill For Monsanto, Patients Claim
On a smaller, but no less important, scale, recent allegations have cast an unfavorable spotlight on Jess Rowland, a former EPA official who plaintiffs say has maintained a “highly suspicious” relationship with Monsanto for years.
As Deputy Division Director, Rowland led the federal agency’s Cancer Assessment Review Committee, according to Lorraine Chow, a reporter for EcoWatch. It was Rowland who chaired the Committee when the EPA’s “unauthorized” review of glyphosate – a report that Rowland himself co-authored – was leaked to the press in May 2016. Just days after the document’s “inadvertent” publication, Rowland suddenly ended his tenure at the EPA.
Now, plaintiffs’ attorneys have cast doubt on Rowland’s role at the agency. “It is clear that Monsanto enjoyed considerable influence within the EPA’s [Office of Pesticide Programs], and was close with Mr. Rowland,” one attorneys in a recent court filing. “The documentary evidence strongly suggests that Mr. Rowland’s primary goal was to serve the interests of Monsanto.”
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