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Daily News Blog

26
Jun

Bayer-Monsanto Chalks Up Court Victory that Takes Cancer Warning Off Roundup™-Glyphosate in California, Makes Case for Fundamental Overhaul of Pesticide Law

(Beyond Pesticides, June 26, 2020) A court decision in California, challenging a cancer warning on products containing the weed killer glyphosate, highlights the distinct  ways in which scientific findings are applied under regulatory standards, in toxic tort cases evaluated by juries, and by consumers in the marketplace. These differences came into focus as a U.S. court quashed California’s decision to require cancer warning labels on glyphosate products on June 22. The ruling, by Judge William Shubb of the U.S. District Court for the Eastern District of California, bars the state from requiring labeling that warns of potential carcinogenicity on such herbicides.

The World Health Organization’s International Agency for Research on Cancer (IARC) in 2015 classified glyphosate as a probable human carcinogen. At this point, Monsanto began a worldwide campaign to challenge glyphosate’s cancer classification. The IARC finding spurred the California Office of Environmental Health Hazard Assessment, in the same year, to announce that glyphosate would be listed as a probable cancer-causing chemical under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). With that announcement came another: the state would mandate that cancer warning labels be applied to glyphosate-based products in the state when any of four legal requirements were met. Put simply, Prop 65 requires businesses to “provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm. Monsanto’s campaign had been mostly unsuccessful, except that the Trump administration’s U.S. Environmental Protection Agency (EPA) declared in 2017 that glyphosate is likely not carcinogenic. Following California’s listing of glyphosate under Prop 65 in 2017, Monsanto sued the state to challenge that listing in Fresno County Superior Court and lost. The company then brought suit (along with a variety of industry stakeholders) against California (and the state’s Attorney General) in federal court in late 2017, claiming that the state’s plan to list glyphosate as a probable carcinogen comprised “unconstitutional forced speech.”

The judge cited as justification for the ruling that: (1) scientific evidence of the carcinogenicity of glyphosate is insufficient to merit such a warning on product labels, and (2) mandating that glyphosate product manufacturers use such labels would comprise “compelled speech,” in violation of the First Amendment to the U.S. Constitution. Meanwhile, just two days before the ruling Bayer-Monsanto announced an over $10 billion settlement covering 90,000+ lawsuits against the company filed by those who linked their non Hodgkins lymphoma to glyphosate exposure. (See more below.)

Glyphosate — the active ingredient in Monsanto’s (now Bayer’s) RoundupTM, the most-used herbicide in the U.S. for nearly two decades — is used very intensively around the world as a weed killer, particularly with Monsanto’s companion seeds for soybeans, cotton, corn, canola, alfalfa, and other crops. These seeds are genetically engineered to be glyphosate tolerant, meaning that growers can apply the herbicide to fields of these crops with an expectation that it will kill weeds and not harm the plant.

In reality, use of glyphosate herbicides has been marked by myriad harms to people and the environment: health impacts (e.g., contributions to cardiac, metabolic, endocrine, respiratory, reproductive, gastrointestinal, and immune dysfunction); threats to numerous organisms (fish, amphibians, and aquatic and terrestrial plants, and some endangered species); and transgenerational health impacts. In addition, as all organisms do, many target plants are developing resistance to the compound, resulting in ever-more intensive and unnerving uses and rollouts of “new” (often with multiple active compounds) pesticides. Beyond Pesticides has covered the many links between glyphosate (and adjuvant ingredients in product formulations) and these myriad health issues.

The long litany of glyphosate lawsuits and appeals is dizzying. Those cases have addressed a variety of issues related to glyphosate’s use, and three high-profile cases that resulted in big-dollar awards to people whose exposures led to development of non Hodgkin lymphoma. (Those cases are currently moving through the judicial appeals process.) The jury in Pilliod v. Monsanto issued a $2 billion verdict based on evidence, not only of the herbicide’s carcinogenicity, but also of Monsanto’s role in suppressing and discrediting independent findings regarding Roundup™ toxicity. In an interview with U.S. Right to Know’s Carey Gillam, co-lead trial counsel Michael Miller said, “Unlike the first two Monsanto trials, where the judges severely limited the amount of plaintiffs’ evidence, we were finally allowed to show a jury the mountain of evidence showing Monsanto’s manipulation of science, the media and regulatory agencies to forward their own agenda despite Roundup’s severe harm to the animal kingdom and humankind.” See the Monsanto Papers.

In a recent development, Bayer, facing some 125,000 lawsuits for claims of harm by glyphosate, announced on June 24 its agreement to pay more than $10 billion to settle approximately 75% of those suits. (The three cases mentioned above are not part of this settlement.)

U.S. Right to Know reports: “Bayer said future Roundup claims will be part of a class agreement subject to approval by Judge Vince Chhabria of the U.S. District Court for the Northern District of California, who ordered the year-long mediation process that led to the settlement. The agreement would take any future findings on cancer claims out of the hands of juries, Bayer said. Instead, there will be the creation of an independent ‘Class Science Panel.’ The Class Science Panel will determine whether Roundup can cause non-Hodgkin lymphoma, and if so, at what minimum exposure levels. Both the plaintiffs in the class action and Bayer will be bound by the Class Science Panel’s determination.”

This provision removes these cases from the jury process, which has been successful for the three high-profile cases. Beyond Pesticides reports, “The Class Science Panel’s determination is expected to take several years. Class members will not be permitted to proceed with Roundup™ claims prior to the Class Science Panel’s determination, and cannot seek punitive damages.” It will be important for Beyond Pesticides and other advocates to monitor the work of this Class Science Panel as it evaluates evidence and makes its determinations.

Direct context for the California District Court decision includes a number of lawsuits and resulting outcomes. Following California’s listing of glyphosate under Prop 65, Monsanto sued the state to challenge that listing in Fresno County Superior Court and lost. The company then brought suit (along with a variety of industry stakeholders) against California (and the state’s Attorney General) in federal court in late 2017, claiming that the state’s plan to list glyphosate as a probable carcinogen comprised “unconstitutional forced speech.” The Environmental Protection Agency (EPA) declared in 2017 that glyphosate was likely not carcinogenic — contradicting (IARC’s) 2015 classification of glyphosate as a probable human carcinogen.

In 2018, Beyond Pesticides and the Organic Consumers Association prevailed against Monsanto’s motion to dismiss their lawsuit, which addressed not California’s situation, but glyphosate labeling broadly. In the case, U.S. District Judge Timothy Kelly found that the plaintiffs had provided “enough evidence to support that Monsanto’s labeling of its flagship weed killer, Roundup, misleads consumers.” In that same year, a California Appellate Court ruled against Monsanto’s challenge to the state’s Prop 65 label listing. Also in 2018, Judge Shubb issued a preliminary injunction preventing California regulators from requiring the cancer warning labels.

In 2019, EPA refused to approve product labels with carcinogenicity warnings. In January of 2020, EPA released an interim decision on glyphosate, asserting a “lack of evidence the chemical causes cancer in humans.” Perhaps anticipating the potential impacts of the maxim, “as goes California, so goes the nation,” EPA Administrator Andrew Wheeler then commented, “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.” EPA’s stance on glyphosate is currently informed by the pro-business, anti-environment, public health–indifferent Trump administration.

Globally, most regulators have decided that glyphosate herbicides are “safe” enough to use — despite the documented harms of exposure. As reported by The New York Times, “Regulators worldwide have determined glyphosate to be safe with the exception of the World Health Organization’s cancer research arm [IARC], which determined the herbicide to be a ‘probable carcinogen’ in 2015. [Judge] Shubb on Monday said that finding alone did not support California’s requirement to label glyphosate products with the term ‘known to the state of California to cause cancer.’”

This June 2020 subject decision came in a suit brought against California’s Attorney General, Xavier Becerra, by Monsanto and a host of trade associations for pesticide manufacturers, agribusinesses, growers, and retailers. It confirmed Judge Shubb’s 2018 preliminary injunction, and asserted: “[I]t is inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization . . . when apparently all other regulatory and governmental bodies have found the opposite. . . . Providing misleading or false labels to consumers also undermines California’s interest in accurately informing its citizens of health risks at the expense of plaintiffs’ First Amendment rights. . . . Accordingly, the balance of equities and public interest weigh in favor of permanently enjoining Proposition 65’s warning requirement for glyphosate.”

The 34-page decision continues, “California has options available to inform consumers of its determination that glyphosate is a carcinogen, without burdening the free speech of businesses, including advertising campaigns or posting information on the Internet (noting that even assuming an advertising campaign would be less effective at broadcasting California’s message than mandated disclosures, the state may not ‘co-opt’ businesses ‘to deliver its message for it’ because ‘the First Amendment does not permit the State to sacrifice speech for efficiency’).” The court denied the defendant’s motion for reconsideration, and Monsanto, et al., welcomed the decision, saying in a statement, “It is widely regarded as one of the safest herbicides ever developed, and the overwhelming scientific consensus is that it does not pose any risk of cancer.”

Judge Shubb’s decision did not comment on whether or not glyphosate has a carcinogenic role; it went only to the “level” of evidence for carcinogenicity and to the First Amendment argument. Juries in the “big three” glyphosate awards cases appear to have had a different take on glyphosate’s carcinogenicity.

Despite the financial and reputational costs to date (with more to come) of Bayer’s glyphosate products, the company appears intent on continuing production and sale of its glyphosate products. Indeed, as Beyond Pesticides reports, “The company said that before deciding to settle, it considered the alternative course of continuing to litigate Roundup™ cases. In the company’s risk assessment, potential negative outcomes of further litigation, including more advertising and growing numbers of plaintiffs, upwards of twenty trials per year and uncertain jury outcomes, and associated reputational and business impacts, likely would substantially exceed the settlement and related costs.” That sounds like a company looking to the future viability of its product line.

Although Bayer logged a “win” in the California labeling suit, the outcome is anything but for residents of the state, and for the U.S. public. With this addition to the ongoing failures of the federal government — whether legislative, executive, or judicial — to enact and enforce protections from glyphosate herbicides, at this moment it falls largely to individuals to protect themselves as best they can. Avoidance of exposure to glyphosate is best achieved in several ways:

Beyond Pesticides has for years monitored developments in the glyphosate saga and advocated for the removal of this dangerous compound from use. This pesticide and hundreds of others on the market and being brought to market, tell the story of a failed federal regulatory system that requires a fundamental overhaul. It provides the justification for the adoption of local and state laws that embrace practices that eliminate toxic pesticides and advance organic management. Beyond Pesticides, and other public and environmental health advocates, will continue the work to move this country — at federal, state, and local levels — toward genuinely precautionary and safe approaches with organic systems.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Sources: https://www.courthousenews.com/judge-halts-california-bid-for-cancer-warning-on-roundup/ and https://www.agri-pulse.com/ext/resources/pdfs/courts/2020-06-22-155-Memorandum.pdf

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