Search results for: glyphosate

  • Glyphosate’s current approval as an herbicide in the European Union (EU) is set to expire on December 15, 2023. In a decision which marked a key step towards a renewal of the approval, on July 7, 2023, the European Food Safety Authority (EFSA) published an updated risk assessment of glyphosate which concluded glyphosate can be used safely in agricultural practices. Though some risks were identified with certain uses, EFSA found no “critical areas of concern” for humans, animals, or the environment from using glyphosate in agriculture.
  • Glyphosate is a broadly used herbicide but is controversial due to differing opinions regarding its impacts on human health and the environment.
  • In 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” (Group 2A). In contrast, a 2020 interim decision by the Environmental Protection Agency (EPA) found there was “no risk of concern to human health” when glyphosate was used as intended and suggested the benefits of glyphosate outweigh potential ecological risks. That interim decision was vacated in part and withdrawn following a decision by the 9th U.S. Circuit Court of Appeals which found that EPA’s analysis had not met the agency’s legal obligations. However, EPA has indicated that its underlying conclusions, including that glyphosate is not likely to be carcinogenic to humans, remain the same and that it will more fully explain its analysis before issuing its final registration review decision, as part of a program that re-evaluates each registered pesticide on a 15-year cycle.
  • Keller and Heckman will continue to monitor and report on legal and scientific updates related to glyphosate.
  • On June 22, 2020, U.S. District Judge William B. Shubb (Eastern District of California) granted summary judgment in favor of Plaintiffs Monsanto Company and a number of farming groups and associations; denied a competing motion for summary judgment filed by California Attorney General Xavier Becerra; and entered a permanent injunction barring enforcement against Plaintiffs of the Proposition 65 (Prop. 65) cancer warning requirements for glyphosate. See National Assoc. of Wheat Growers et al. v. Becerra, Case No. 2:17-civ-02401, 2020 U.S. Dist. LEXIS 108926 (E.D. Cal. June 22, 2020).
  • On Nov. 14, 2017, Plaintiffs sued Lauren Zeise, director of California’s Office of Environmental Health Hazard Assessment (OEHHA) (who was later dismissed from the case and replaced with the Attorney General), alleging in part that OEHHA’s listing of glyphosate under Prop. 65 as a carcinogen, and the resulting warning requirements, violate Plaintiffs’ First Amendment rights by compelling them to make “false, misleading, and highly controversial statements.” As previously reported in this blog, and reiterated in the Memorandum and Order at issue, the Court initially entered a preliminary injunction precluding enforcement of the warning rules (but declined to prohibit the placement of glyphosate on Prop. 65’s list of carcinogens, as it constituted permissible governmental speech). See Wheat Growers, 2020 U.S. Dist. LEXIS 108926, at ** 8, 26. Without reaching issues such as whether glyphosate is indeed carcinogenic, or whether Prop. 65 is good policy, the Court found that the safe harbor warning language stating that glyphosate is “known to the state of California to cause cancer,” could mislead the average consumer, as “[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 [International Agency for Research on Cancer (IARC)] . . . when apparently all other regulatory and governmental bodies have found the opposite.” See id. at **9-10.
  • After affirming its prior decision that the First Amendment challenge was ripe, the Court determined that the compelled Prop. 65 warning did not constitute “purely factual and uncontroversial information”; thus, the Court refrained from applying the corresponding lower standard of scrutiny under Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985). See id. at **19-24. Instead, having determined that Zauderer was inapplicable, the Court applied intermediate scrutiny under Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), and determined that the government failed to meet its burden of showing that Prop. 65’s warning requirement for glyphosate directly advances the asserted government interest, and that the compelled speech is not more extensive than necessary to achieve that interest. See id. at **34-36.
  • We will continue to monitor this case, throughout the potential period of appeal to the Ninth Circuit Court of Appeals. This ruling (if upheld or not appealed) potentially opens the door to challenge other Prop. 65 warning requirements where evidence of carcinogenicity or reproductive toxicity is arguably inadequate or controversial.

Rachel Ray Dog Food Once Again Ducks False Ad Suit (Law360 subscription required)

  • We reported on a proposed class action lawsuit filed in 2018 against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that found residues of the herbicide, glyphosate.  The New York District Judge in the Nutrish case dismissed the claims in April of last year for failure to indicate the level of glyphosate detected and to say whether it was harmful.
  • An amended complaint provided analytical results but did not address harm, continuing to argue instead that any amount of glyphosate in the pet food renders the “natural” claim false and misleading.  The judge dismissed the complaint a second time upon finding the total glyphosate alleged to be present in the Nutrish samples is between 0.005% to 0.01% of the Food and Drug Administration’s (FDA) allowed tolerance, and ruled that labeling such pet food as “natural” is not materially misleading to a reasonable consumer.
  • There may be less potential for consumer confusion for pet food, as compared to human food, because the pet food term “natural” has an official definition through the Association of American Feed Control Officials (AAFCO).  The lawsuit against Nutrish, however, while unsuccessful, pending any possible appeal, shows that natural claims on pet food could nevertheless be a target for litigation.

 

  • In a direct rebuke of Proposition 65’s listing of glyphosate as a carcinogen, the US Environmental Protection Agency (EPA) issued a press release on August 8, 2019 announcing that it would no longer approve glyphosate labels with the Proposition 65 warning for cancer.  EPA Administrator Andrew Wheeler is quoted in the press release as stating, “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.”
  • On August 12, 2019, the California agency that administers Proposition 65, the Office of Environmental Health Hazards Assessment (OEHHA), released a statement responding to EPA’s press release, highlighting that glyphosate was added to Proposition 65 based on findings by the World Health Organization’s International Agency for Research on Cancer (IARC).  OEHHA stated, “It is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
  • The exchange between EPA and OEHHA is the latest chapter in the ongoing controversy concerning the safety of glyphosate, which was listed as a carcinogen under Proposition 65 in 2017, subject to a safe harbor level of 1,100 micrograms per day.  It is unclear how EPA’s announcement will impact Proposition 65 liability for glyphosate in California.
  • A California plaintiff, who used Roundup on his 56-acre Santa Rosa property and alleged glyphosate caused his non-Hodgkin lymphoma, has been awarded $80 million by a jury in the U.S. District Court for the Northern District of California.  The docket of the case, Hardeman v. Monsanto Co. et al., is available here (subscription required).  This verdict is the second significant glyphosate judgment against Bayer-owned Monsanto, following on the August 2018 verdict that awarded a former school groundskeeper $289 million (later reduced to $78 million by a judge reviewing the case). 
  • In a statement after the verdict, Bayer expressed disappointment but stressed that the science supports that its glyphosate products are not carcinogenic.  In particular, Bayer quoted a recent Health Canada statement that “no pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed.”
  •  Hundreds of additional cases are forthcoming, including a federal multi-district litigation scheduled to begin at the U.S. District Court for the Northern District of California on May 20, 2019. 

 

  • On October 1, 2018, the U.S. Food and Drug Administration (FDA) released a report showing the majority of human and pet foods produced and imported into the U.S. during FY 2016 tested below the federal limits for pesticide chemical residues. FDA tested for 711 pesticides and industrial chemicals in 6946 human food products and 467 animal foods during the fiscal year running from Oct. 1, 2015 to Sept. 30, 2016 under the FDA’s Pesticide Monitoring Program. For human food products, FDA found that over 99% of domestic and 90% of import human foods were compliant with federal standards. Further, no pesticide chemical residues were found in 52.9% of the domestic and 50.7% of the import samples that FDA analyzed.
  • FDA also publicized the findings of its “Collection of Selected Domestic and Imported Foods for Herbicides Analysis” study that examined residues of glyphosate, glufosinate, and 30 selected acid herbicides in foods.  Glyphosate, the active ingredient in popular garden weed killers and one of the most-used agricultural chemicals in the world, has been the subject of much controversy. As previously reported on this blog, on August 10, 2018, a San Francisco jury awarded a former school groundskeeper dying of non-Hodgkin’s lymphoma $289 million against Monsanto for claims that the Roundup herbicide was a substantial contributing factor in causing his cancer.
  • Analyzing 274 grain corn, 267 soybean, 113 milk, and 106 egg samples, FDA found non-volatile levels of glyphosate in 63.1% of corn samples and 67% of soybean samples. Non-volatile levels of glufosinate were found in 1.4% of corn tested and 1.1% of soybeans. In a statement accompanying the release of the results, FDA Commissioner Scott Gottlieb said, “…the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”
  • A California Court of Appeals has rejected various arguments made by Monsanto Company, challenging the listing of glyphosate based on the Proposition 65 Labor Code listing mechanism, where carcinogens listed by the International Agency for Research on Cancer are automatically listed under Proposition 65.
  • The court did not agree that the Labor Code listing of IARC carcinogens amounted to an unconstitutional delegation of “a quasi-legislative authority to an outside agency without providing for adequate standards or appropriate safeguards.”  The court noted that Californians voted to pass Proposition 65 in part because they felt that state agencies had failed to adequately protect individuals from chemical exposures and decided that—at a minimum—some substances would be listed based on the Labor Code listing mechanism as a matter of course.
  • This decision adds to the caselaw concerning glyphosate under Proposition 65.  It remains to be seen where the dust will settle with regard to Proposition 65 warnings for glyphosate, which is now the subject of a 1,100 microgram safe harbor level, given the outcome of a recent decision in which a California federal court agreed that such warnings would be misleading commercial speech under the First Amendment of the Constitution.
  • On April 6, 2018, California’s Office of Environmental Health Hazard Assessment adopted a No Significant Risk Level (NSRL) of 1,100 micrograms per day for glyphosate.
  • Glyphosate was listed as a carcinogen on July 7, 2017.  In theory, failure to warn for glyphosate exposure exceeding the NSRL would become mandatory on July 7, 2018.
  • However, a federal district court recently granted an injunction to plaintiffs from providing warnings for glyphosate because such warnings would not be “factually accurate.”  Given that the litigation is still pending, it is not yet certain how the duty to warn for glyphosate exposures will be enforced in the future.

 

  • A California court has granted an injunction enjoining various growers associations from providing Proposition 65 cancer warnings for crops grown with glyphosate.  In a motion for preliminary injunction, National Association of Wheat Growers et al. v. Zeise, the court held that a Proposition 65 warning conveying that glyphosate causes cancer would not be “factually accurate” and would be “misleading to the ordinary consumer” because almost all other regulators (i.e., apart from California’s Office of Environmental Health Hazard Assessment (OEHHA)) “have concluded that there is insufficient evidence that glyphosate causes cancer.”
  • Glyphosate was listed on Proposition 65 in July 2017, and enforcement of the warning requirement would begin in July 2018.  For more on upcoming changes to Proposition 65 “clear and reasonable” warning requirements, see https://www.khlaw.com/9500.
  • The decision may be a useful precedent in the event that other companies and organizations decide to push back on Proposition 65 warnings based on arguably inadequate evidence of carcinogenicity or reproductive toxicity.
  • As previously covered on this blog, back in February of this year, FDA announced that it would begin testing foods for glyphosate residues. By way of background, glyphosate is the active ingredient in popular garden weed killers and is reported to be the most-used agricultural chemical in the world.  Some environmental groups have called for a ban on the use of this substance in agriculture.  The International Agency for Research on Cancer (IARC) has labeled this herbicide as “probably carcinogenic to humans,” although the European Food Safety Authority (EFSA) disputes that conclusion.  In the United States, FDA has not routinely tested foods for the presence of glyphosate, in spite of a U.S. Government Accountability Office (GAO) recommendation that the Agency improve its testing methods and be more transparent with the public regarding the limitations of its analytical testing.
  • In media reports last week, FDA confirmed that the Agency’s testing for residues of glyphosate has been put on hold.  The FDA’s residue testing for glyphosate was part of a broader herbicides analysis program which commenced earlier this year.  According to media reports, FDA’s glyphosate testing has been somewhat challenging as there has been some disagreement regarding testing methodology.  When glyphosate testing resumes (at a date to be determined), testing is slated to be significantly expanded.  In the meantime, FDA has said that preliminary results showed no violations of legal tolerance levels allowed for glyphosate in the foods tested.
  • To be sure, glyphosate will continue to be the subject of controversy – both here at home and abroad.