On April 23, 2019, EPA took another step toward upholding the registration of glyphosate by issuing a Proposed Interim Registration Review Document (“PID”) which concludes that the herbicide is not likely to be a human carcinogen. This decision comes as three juries have awarded hundreds of millions of dollars to four individuals suffering from Non-Hodgkin’s Lymphoma alleged to have been caused by repeated exposure to glyphosate.
EPA Actions Support Continued Registration
A PID is a step in the Pesticide Registration Review process under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) by which EPA regularly revisits registered ingredients to determine whether they continue to present an acceptable risk to humans and the environment. It is the latest in a series of actions beginning in 2009 focused on the risks presented by glyphosate. The glyphosate proposed PID represents a major marker in the international debate over whether glyphosate is a potential carcinogen. It was posted in the glyphosate docket on May 6, 2019, and comments are due by July 5, 2019. See https://www.regulations.gov/document?D=EPA-HQ-OPP-2009-0361-2340.
EPA had in December 2016 convened a FIFRA Scientific Advisory Panel meeting to consult on a draft risk assessment of the carcinogenic potential of glyphosate. Based on comments received from the SAP EPA revised its cancer assessment and issued theResponse to the Final Report of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) on the Evaluation of the Human Carcinogenic Potential of Glyphosate. EPA’s final cancer conclusion and its rationale for reaching this conclusion are described in the Revised Glyphosate Issue Paper: Evaluation of Carcinogenic Potential.The EPA’s final cancer assessment includes the newly published analysis of glyphosate use and cancer incidence in the Agricultural Health Study (AHS). The AHS study is a long-term epidemiological study of over 54,000 pesticide applicators to investigate the association between pesticide exposures and incidence of various types of cancer and non-cancer outcomes. The EPA’s review of the AHS study is described in the Summary Review of Recent Analysis of Glyphosate Use and Cancer Incidence in the Agricultural Health Study. The agency has determined that glyphosate is not likely to be carcinogenic to humans and therefore a quantitative cancer assessment was not conducted.
NGO and Organic Food Producers File Petition to Lower Glyphosate Tolerance for Oats
On September 27, 2018, the Environmental Working Group and a series of organic food producers filed a petition to lower the tolerance for glyphosate in or on oats from 30 ppm to 0.1 ppm and to prohibit preharvest use on oats. The petition was posted on Docket EPA-HQ-OPP-2019-0066 on May 6, and comments are due by June 5, 2019. EPA has stated that it anticipates responding to the petition as part of finalizing the PID.
IARC Classification & Proposition 65
The opponents to glyphosate use were bolstered by a March 2015 determination of the World Health Organization’s International Agency for the Review of Cancer (“IARC”), which found glyphosate to be a probable human carcinogen. See https://www.iarc.fr/featured-news/media-centre-iarc-news-glyphosate/. That decision has been hotly disputed by industry and regulators, including EPA, but continues to be supported by IARC. Neither the European Union’s Food Safety Authority (2015) nor the U.S. National Toxicology Program (2016) have classified glyphosate as a human carcinogen.
The IARC classification resulted in glyphosate being added as a probable carcinogen under California’s Proposition 65. While the listing continues in place, as a result of industry litigation registrants of glyphosate have been relieved of the obligation to advise persons exposed to it of the cancer risk. See National Association of Wheat Growers v. Zeise (Civ. No. 2:17-2401 WBS EFB) (February 26, 2018)
Private Tort Litigation
As the regulatory actions play out a series of thousands of private actions have been filed in Federal and state courts. Plaintiffs have prevailed in the first three trials to proceed to a verdict.
In Johnson v. Monsanto,the jury in a San Francisco County Superior Court action awarded approximately $289 million in damages, which was reduced by the judge to approximately $78 million. Bayer, which now owns Monsanto, is appealing the verdict and the plaintiff is appealing the reduction of damages.
In Hardeman v. Monsanto, the first of thousands of cases consolidated in a Multi-District Litigation (“MDL”) in the Northern District of California, the jury awarded $5.2 million in compensatory damages and $75 million in punitive damages. On April 11, 2019, the judge hearing the MDL cancelled the next scheduled bellwether trial, scheduled a hearing May 22 to address how to proceed in the MDL and ordered the parties to engage in mediation.
Most recently on May 13, 2019 the jury inPilliod v. Monsantoin California’s Alameda County Superior Court awarded a married couple $1 million each in compensatory damages and $1 billion in punitive damages. This scale of punitive damages exceeds the permissible ratio of punitive damages to compensatory damages allowed in California, so even if the verdict survives appeal the punitive damage amount will be reduced.
The litigation has proved to be a challenge for Bayer, whose stock has dropped approximately 50% from its 52-week high. In addition, at the April 26 Bayer annual meeting, in a non-binding resolution, a majority of shareholders voted to disapprove Bayer’s actions related to glyphosate.
It remains to be seen whether the two verdicts to date will withstand appeal. Expert testimony is critical to any toxic tort plaintiff’s case, because without expert testimony the necessary causation link can never be established. In Federal court the admissibility of any proposed expert witness testimony must be evaluated according to the five-part standard established by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The Federal judge in the Hardeman bellwether case held that “So long as an opinion is premised on reliable scientific principles, it should not be excluded by the trial judge; instead the weaknesses in an unpersuasive expert opinion can be exposed at trial, through cross-examination or testimony by opposing experts.”
More sense of the directions in which the Federal MDL litigation may go should be learned from the May 22, 2019 conference. Other than directing the parties to select a mediator, nothing further is scheduled at the moment. Several trials are scheduled for the fall of 2019 in St. Louis, Missouri County Court.
While the litigation continues, EPA appears determined to continue the registration of glyphosate. Evidence introduced in one of the trials contained assertions that the administration supports Bayer and the continued registration. Assuming EPA denies the petition related to oats, that matter will no doubt be litigated.