Court Rules that California Proposition 65 Cancer Warning on Glyphosate Products Would Unlawfully Compel Registrants to Engage in Controversial Speech

A ruling this week from the U.S. District Court for the Eastern District of California held that requiring registrants of glyphosate products to be the subject of a Proposition 65 cancer warning would violate the 1st Amendment rights of such registrants.  National Association of Wheat Growers et al v. Becerra, Attorney General of California [No. 2:17-cv-2401 WBS; opinion available only through Federal PACER System.]  The Court ruled that by compelling them to engage in speech that is controversial and in the opinion of the U.S. Environmental Protection Agency (“EPA”) false would make the products misbranded would violate the registrants’ rights under the 1st amendment.

Proposition 65 requires sellers of products in California that the state has determined contain substances which are carcinogenic or teratogenic to provide warnings of exposure to such substances. Warnings can be in the form a statement on the product label or a notice placed at the point of sale.  California can make such a determination on its own but is also required under the law to accept the determinations of outside expert bodies, including EPA, the U.S. National Institute for Occupational Safety and Health (or NIOSH, a component of the Centers for Disease Control), the U.S. National Toxicology Program (or NTP which is part of the National Institutes of Health), and the International Agency for Research on Cancer (or IARC, which is the research arm of the U.N. World Health Organization (“WHO”).

The dispute in this case involves the assertion by California that glyphosate causes cancer. That determination was based upon a 2015 determination by IARC that glyphosate is a probable carcinogen. As an outside expert body whose determination is binding under Prop 65, California proceeded on July 7, 2017, to add glyphosate to the Prop 65 list and advise registrants of their obligation to comply within one year.  

The IARC determination of carcinogenicity of glyphosate is the only review that reached such an outcome. EPA has adamantly contended that glyphosate is not a carcinogen.  See EPA Review of the Carcinogenic Potential of Glyphosate.  Reviews by other international bodies, such as the European Commission for Health and Consumer Protection Directorate-General, the WHO International Programme on Chemical Safety, as well as other individual nations, such as Canada and Australia, concurred with EPA and not IARC.

A group of twelve national and state trade associations and grower groups, as well as the registrant Monsanto brought suit, and on February 26, 2018, the Court preliminarily enjoined California from enforcing the warning requirement. The issue now before the Court was whether to permanently enjoin the warning requirement for glyphosate, which it did.

The Court presented a history of the litigation over commercial speech, beginning with the U.S. Supreme Court decisions in Central Hudson Gas & Electric Corporation v. Public Service Commission  (1980) and Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio  (1988), which addressed respectively a speech limitation imposed by New York State and speech compelled by the State of Ohio. The standard established by Zauderer requires a determination by the reviewing Court that the compelled speech is factual and non-controversial. If not, then the stricter standard of review established by Central Hudson applies.

The Court found that the required notice was not purely factual and was in fact controversial, this triggering the stricter standard of review. The Court found that in the context of the professional disagreements on the carcinogenicity of glyphosate, the required warnings would be false and misleadingly imply that no dispute exists as to the issue of carcinogenicity. The Court also pointed out the irony that while EPA is an expert outside body under Proposition 65 whose position is binding, EPA has determined that placing the required warning on a pesticide would make the product misbranded, since EPA contends the statement is false.

In an effort to salvage a warning requirement, California offered a variety of alternative wordings for the warning. The Court rejected all alternatives, saying they would not adequately advise the public of the underlying scientific conflict and would still subject registrants to potential enforcement litigation brought by private parties.

It remains to be seen whether California will appeal this decision to the 9th Circuit.  If it does so the chances for success seem limited. While this decision may conclude this aspect of the controversies over glyphosate, the various tort suits alleging that glyphosate causes Parkinson’s Disease continue to wend their way through various trials and appeals.   

Meanwhile as of this writing EPA continues to refuse to allow any pesticide registrant whose product is subject to a Proposition 65 notice requirement to place such a notice on a pesticide label. This limitation was originally imposed during the litigation, but EPA gives no indication as to when or how it will address notice requirements for other ingredients  Registrants with such products are left with the unsavory choice of forging the California market or risk State or private enforcement action.

New York to Adminstratively Eliminate All Uses of Chlorpyrifos [Updated]

Despite its registration having been upheld by the U.S. Environmental Protection Agency (“EPA”), the insecticide chlorpyrifos continues to face multiple challenges to its continued use. The continued EPA registration continues to be challenged in Court by a collection of states, while California has secured the agreement of major registrants to administratively cancel all registration. Now the New York Governor has directed the Department of Environmental Conservation (“NYSDEC”) to administratively phase out most uses of the ingredient.

In New York, the legislature 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. In a somewhat contradictory move, rather than signing the legislation, the Governor vetoed it but has directed the NYSDEC to promulgate rules largely mirroring the vetoed legislation. The Governor’s Veto Message stated that pesticides should not be regulated by legislative mandate, but instead by NYSDEC on the basis of science. The Veto Message stated that NYSDEC will act to immediately ban aerial application; most remaining uses are to be eliminated by July 1, 2021.

New York has a procedurally complex rulemaking process. To propose a rule, the moving agency must first secure approval of the State Division of the Budget. A proposed rule is then published, which must be accompanied by a series of documents assessing the impacts of the proposed rule, including a Regulatory Flexibility Analysis, a Rural Area Flexibility Analysis and a Job Impact Statement. If not finalized within a year of publication, a proposed rule expires. In fact, it often consumes most of that year to arrive and publish a final rule.  To achieve the objective of immediately eliminating aerial application, NYSDEC will need to promulgate an emergency regulation, followed by a proposed permanent rule.  The emergency rule will need to be supported by a statement justifying the need for an emergency rule.

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 said, a state must still follow its own procedures and meet its own legal standards to support a rulemaking. Although EPA has concluded that chlorpyrifos does not present an unacceptable risk, that decision was arrived at in part by excluding epidemiological data developed by the Columbia University’s Center for Children’s Environmental Health and Mt. Sinai Hospital.  EPA asserts that the data is not valid, complete and reliable data unless EPA is granted access to the underlying raw data.  The study sponsors have refused to supply such information, claiming that to do so would violated subject confidentiality. New York will be free to include that study as a basis for its action without demanding the underlying data and is likely to do so.  Bottom line: even if challenged, done correctly New York’s anticipated rule is likely to be upheld.

With chlorpyrifos on its way out in two major states, it remains to be seen whether chlorpyrifos remains on the market, regardless of the outcome of the litigation.

 

California Reaches Agreement with Registrants to End Chlorpyrifos Use 

           After previously issuing a Notice of Intent to Cancel the California registrations of chlorpyrifos, the California Department of Pesticide Regulation (“CDPR”) has announced that an agreement has been reached with Dow AgroSciences and other producers to eliminate all agricultural uses.  Given its major role in agricultural, the cancellation in California could well be a harbinger of the end of chlorpyrifos.  As recounted in prior blog entries, EPA and chlorpyrifos registrants have been fending off challenges for almost ten years.  See our previous blog entry EPA Denies Chlorpyrifos Cancellation Petition; Six States File Challenge in 9thCircuit.  California’s action represents the most significant victory to date for opponents.

The California agreement provides for the following staged elimination of the product:

November 8, 2019:   Final date for sales by registrants into or within California;

February 6, 20020:   Final dates for any sales by dealers in California; and

December 31, 2020:  Final date for any use or possession other than for the purpose of disposal.

Any use until the deadline is subject to CDPR’s will now mandatorily be subject to the Chlorpyrifos Interim Recommended Permit Conditions issued in November 2018. See our previous blog entry EPA Denies Chlorpyrifos Cancellation Petition; Six States File ChLLCDPR also has created a “cross-sector working group” to develop recommendations for alternatives.

Meanwhile the litigation challenging the EPA registration continues in the 9thCircuit U.S. Court and the legislation eliminating use in New York still awaits a Governor’s decision as to whether to sign it.

U.S. Environmental Protection Agency Determines that California Proposition 65 Cancer Warnings on Glyphosate (“Roundup®)” Labels Are Misleading; Orders Their Removal

On August 7, 2019, the U.S. Environmental Protection Agency (“EPA”) announced that it had determined that cancer warnings placed on glyphosate (“Roundup®)” labels in compliance with California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known as Proposition 65, are misleading, since EPA does not recognize the data used to determine that glyphosate is a potential carcinogen. In a letter to glyphosate registrants, EPA stated that the presence of such a misleading statement on a pesticide label renders the product misbranded, and has ordered registrants to file proposed amended labels removing the Proposition 65 statement.

The determination that glyphosate is a potential carcinogen was made by the International Agency for Research on Cancer (“IARC”), a unit of the World Health Organization. That determination in turn triggered an automatic classification as a carcinogen under Proposition 65, thereby triggering the obligation to place a cancer warning on glyphosate labels. EPA has disagreed with the IARC classification since it issuance. It issued its revised Evaluation of Carcinogenic Potential on December 17, 2017, and in April 2018, issued its final determination that glyphosate does not pose a threat of cancer.

Industry brought a successful challenge to the automatic listing, and secured a preliminary injunction preventing California from enforcing the label notice requirement.  See National Association of Wheat Growers v. Zeise,  309 F. Supp. 842 (EDCA February 26, 2018).  Notwithstanding the lack of enforcement, a number of labels already bore the Proposition 65 notice, which, given the nature of pesticide label regulation, cannot simply be removed.

It remains undetermined how the label amendment process will play out. The EPA letter simply requested that a proposed amended label be submitted, without specifying whether a notification pursuant to EPA Pesticide Registration Notice 98-10 will suffice, or whether a formal amendment is required. Either way this process is bound to prove cumbersome for affected glyphosate registrants.

 

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 thousand 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 Hardemanbellwether 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 mater will no doubt be litigated.

May 14, 2019

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 LULACmatter, 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, 2018