Scientific Debate Over Glyphosate Safety Continues As 3rd Jury Finds Against Monsanto

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.

Conclusion

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.

Challenges to Chlorpyrifos Grow

             In the ongoing saga of the organophosphate insecticide chlorpyrifos, its registration is facing multiple new challenges on a variety of fronts. On the Federal level, attention is focused on the years-long pending Petition to Cancel filed with the U. S. Environmental Protection Agency (“EPA”) by the Natural Resource Defense Council (“NRDC”) and the Pesticide Action Network of North America (“PANNA”). On the state level, the California Department of Pesticide Regulation (“CDPR”) has announced its intention to cancel all registrations of chlorpyrifos, and the state of New York appears headed to enacting a legislative ban on its registration in New York.

Petition to Cancel EPA Registrations

            The Petition to Cancel was filed in 2007.  Its history and related litigation is recounted in the prior blog entry EPA Obtains Stay of Execution for Chlorpyrifos from 9thCircuit Court of Appeals. On 2017 EPA had announced that, contrary to staff recommendation to cancel the registrations of chlorpyrifos, it was denying the Petition. See 82 Fed. Reg. 16581 (April 5, 2017).  EPA announced that more data was required to make a decision and therefore a final determination on the safety of chlorpyrifos the review would not be completed until 2022.

            Petitioners, joined by five states and the District of Columbia, sought to have the 9thCircuit Court of Appeals compel EPA to grant the Petition and cancel the registration. Initially a three-judge panel of the 9thCircuit ordered EPA to cancel the registrations and tolerances for chlorpyrifos. See League of United Latin American Citizens et al v. Wheeler, 899 F. 3d 814 (9thCir.). EPA then sought rehearing by the full 9thCircuit. Following argument before the full panel, the Court on April 19, 2019 revoked the prior opinion and issued a Writ of Mandamus ordering EPA to respond to the Petition within 90 days, making the deadline approximately July 19.

           Given that EPA determined in its Revised Human Health Hazard Assessment and Drinking Water Exposure Assessment for Chlorpyrifos [November 2016] to revoke all food residue tolerances for chlorpyrifos, EPA will face an uphill challenge if it wishes to maintain the chlorpyrifos registrations. It is certain that anything short of a full cancellation will bring this matter back before the 9thCircuit.

California and New York Actions

            California and New York have determined that they will not await the outcome of EPA determination on the Petition and through different channels are both moving to terminate chlorpyrifos in their respective states. 

           In California, CDPR announced on May 8, 2019 that it intends to initiate cancellation proceedings for all chlorpyrifos registrations. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.

           In New York, which is one of the intervenor states in the LULAC matter, as of April 30, 2019, both houses of the legislature have passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021. While the New York Farm Bureau is on record opposing the legislation, the governor has given no indication of whether he will sign the bill. If he does so, opponents would likely have no recourse. Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That authority leaves opponents with little ground upon which to mount any challenge.

May 10, 2019

 

Renewed Pesticide Registration Improvement Extension Act Signed Into Law

 On March 8, 2019 the President signed into law S. 438, the Pesticide Registration Improvement Extension Act of 2018. Thus the PRIA fee for service program, which had lapsed as of February 19, 2019, is back in force. Presumably anyone who submitted an application since the lapse can if they wish withdraw and refile the application. If one does so, by paying the PRIA fee they would have guaranteed decision date for their action. More details are expected from EPA as the new law is implemented.

 

 

EPA Obtains Stay of Execution for Chlorpyrifos from 9th Circuit Court of Appeals

 

In a rare move, on February 6, 2019, the U.S. Court of Appeals for the 9thCircuit agreed to an en bancrehearing of its decision in League of United Latin American Citizens (“LULAC”) v. Wheeler, 899 F. 3d 814 (9th Cir. 2018). That decision had ordered EPA to cancel all registrations of chlorpyrifos and revoke all chlorpyrifos domestic tolerances.

The original decision in LULACwas issued on August 9, 2018. It came some eleven years after Pesticide Action North America (“PANNA”) and the Natural Resources Defense Council filed a Petition with EPA seeking the revocation of chlorpyrifos tolerances. Since tolerances are required for the food use of pesticides, tolerance revocation would eliminate all domestic agricultural uses.  Tolerance revocation was the approach used by EPA when it sought to eliminate all food uses of carbofuran. See National Corn Growers Ass’n v. EPA, 613 F.3d 1131 (D.C. Cir. 2010).

By 2014, having received only partial responses, the Petitioners filed suit in the 9thCircuit seeking to compel a response to the Petition. That action was dismissed based upon EPA’s commitment to issue a decision by February 2014.  When a decision was not issued Petitioners again filed suit in the 9thCircuit, and were successful in having EPA ordered to issue a decision by October 2015. See In re PANNA, 798 F.3d 809 (9thCir. 2015). Because of this order, EPA proposed to revoke the chlorpyrifos tolerances. See 80 Fed. Reg. 69,080 (Nov. 6, 2015).

However, EPA did not proceed to a final action, as a result of which the 9thCircuit issued another Order requiring EPA to take final action by December 30, 2016. See In re PANNA, 808 F.3d 402 (9thCir. 2015).  Prior to taking final action on the Petition, EPA issued a revised risk assessment. See 81 Fed. Reg. 81,049 (Nov. 17, 2016). It found that the chlorpyrifos tolerances allowed aggregate exposures to chlorpyrifos which exceeded the safety standards of the Food Quality Protection Act, and thus should be revoked.

However, days before the Court-imposed deadline, EPA announced that it was denying the Petition in full. EPA stated that it found that more data was necessary to make a final decision on chlorpyrifos, and that it would complete its review of chlorpyrifos by the registration review deadline of October 1, 2022.  See 82 Fed. Reg. 16,581 (April 5, 2017).  That announcement prompted Petitioners to renew their litigation, resulting in the August 9, 2018 decision ordering the revocation of tolerances and the cancellation of registrations.

Much of the attention in the litigation has been focused on procedural issues unrelated to the actual science surrounding chlorpyrifos. EPA expended significant effort seeking to have the Court find that it did not have jurisdiction to hear the case, and there was a dissent to the August 9, 2018 decision agreeing with EPA’s position. Since EPA acts under the authority of the Food Drug and Cosmetic Act (“FFDCA”) with respect to tolerances, reviewability is determined under that statute. EPA argues that under the FFDCA the matter is not ripe for judicial review until EPA responds to comments to the April 5, 2017 publication. Plaintiffs argue that the response to comments is not jurisdictional and the case should be allowed to proceed, especially since EPA has stated that they do not intend to respond further until the final registration review position is issued, likely in 2022.

EPA was so focused on the jurisdictional issue that it offered no substantive defense on the risks of chlorpyrifos.  Of course any such defense would be hamstrung by the prior public positions supporting the tolerance revocation.  It remains to be seen whether EPA offers any substantive defense in the rehearing.

It is worth stressing again how rare a grant of rehearing en bancis. The Federal Rules of Appellate Procedure set a high standard for granting rehearings, requiring that the original panel decision either directly conflict with another decision of the 9thCircuit or another Circuit Court, or that the issues presented are of “exceptional significance.” Since there does not appear to be another Circuit decision directly at odds, by implication a majority of the active judges in the Circuit must have agreed that the FFDCA and FIFRA issues presented by this case are of such significance.

Another interesting aspect of this litigation is that the author of the LULAC was U.S. District Court Judge New Rakoff from the Southern District of New York, sitting by designation.  Judge Rakoff will not part of the en banc panel, which could shift the balance in the case. Given the time required for briefing, scheduling of argument and deliberation, it is likely that a decision will not be forthcoming until the latter half of 2019.

 

EPA Attempt to Delay Certified Pesticide Applicator Rule Overturned by Court

In an action brought by a major Latino farmworker union,  the U.S. District Court for  the Northern District of California overturned efforts by EPA to delay the implementation of the Certified Pesticide Applicator rule. In January 2017, the EPA determined to revise the rule and in the interim sought to postpone its effective date from March 2017 to  March 2020. The judge ruled that the delay would cause the plaintiffs to suffer injury and that EPA failed to comply with the Administrative Procedures Act. The Court annulled the rulemakings postponing the rule and reinstated the original timeline for implementation.

This decision represents a major victory for agricultural and pesticide workers. Of these revisions, the most significant entail strengthening regulations on certified applicators.  Certification is required for the use of restricted use pesticides (RUPs). RUPs are known to be highly toxic and responsible for acute toxicity issues in persons that apply and handle them. The rule requires states to update their certification plans in accordance with the updated regulations, and to combat poisoning issues and promote worker safety, establishes for the first time a nationwide minimum age for certifying pesticide applicators. The rule mandates that people be at least 18 years old to become certified, with a provision that allows family members at least 16 years old to become certified, effective only on the certified applicator’s family farm.