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

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 a guaranteed decision date for their action. More details are expected as EPA implements the new law.

Congress Allows Pesticide Registration Improvement Act to Expire

Despite both EPA and industry support, Congress failed to include a renewal of the Pesticide Registration Improvement Act (“PRIA”) in the budget adopted for EPA for the remainder of fiscal year 2019, ending September 30, 2019. PRIA is a fee for service program, under which applicants for pesticide registrations or amendments pay a specified fee for the type of action and in return are given a firm date by which the action can be expected to be completed.  Originally enacted in 2004, this enactment would have been the fourth iteration of the program.  The program added certainty to process that previously had been chaotic.

In its absence, EPA has advised industry participants that as of February 16, 2019, fees will be reduced by 70%, but no deadlines will apply to actions in question.  All applications submitted prior to February 16 will still be subject to the PRIA decision times.

The Senate has passed a stand-alone re-enactment of PRIA, but is future remains uncertain.  Until the picture becomes clearer, it might be the wiser course to refrain at the moment from filing any applications.  If PRIA is re-enacted, it may retroactively cover filings during the lapse of the Act, but that is by no means a certainty.

EPA Pesticide Program Reopens to Challenging Workloads

Now that EPA is again operating, some signals are coming from the Agency as to how the pesticide work backlog will be addressed. Points of interest are:

  • As to actions subject to the Pesticide Registration Improvement Act (“PRIA”) for which the decisions deadline fell during the shutdown, EPA intends to renegotiate the deadline with the applicant.
  • The budget extender that runs through February 15, 2018, was retroactive to December 21, 2019, so actions submitted during the shutdown that fall within PRIA are subject to the full PRIA fee and the PRIA timeframes.  
  • Since reopening EPA has experienced a significantly increased volume of pesticide submissions and expects high submission volumes over the next two weeks because of the uncertainty around another shutdown.

Given the strained circumstances with pesticide program, one certainty is that acknowledgments of pesticide notifications are likely to be very long in coming.

U.S. Environmental Protection Agency’s Office of Pesticide Programs Issues Guidance on Impacts of Agency Closure on Pesticide Regulatory Actions

The U.S. Environmental Protection Agency’s Office of Pesticide Programs has issued the following guidance to the registrants and producers of pesticides describing the impacts of the partial closing of the U.S. government, which includes EPA:

Due to the government shutdown, any submissions to EPA after December 28, 2018, will not be considered received or processed until after a change in EPA’s operational status for work to resume. Please note that the Pesticide Registration Improvement Renewal Act (PRIA 3) expired on December 21, 2018. Per phase-out provisions described in FIFRA sec. 33(m)(2)(B), registration service fees for new applications received after that date will be reduced by 70% from the fiscal year 2017 levels. In addition, such applications will not be subject to the decision review time frames specified in PRIA 3. Pending a change in EPA’s operational status, applications received after December 21, 2018, will be subject to these new provisions, and applications received on or prior to December 21, 2018, will continue to be reviewed under the decision time frames specified in PRIA 3.

Aside from the obvious impact that work will not be performed while OPP employees are furloughed, the major impact will be on parties seeking new registrations or amendments to existing registrations. PRIA is a fee-for-service statute governing all major pesticide regulatory actions by EPA. Each covered action is assigned a review period and a processing fee. PRIA has added certainty to the regulatory process, providing applicants with a firm decision date that facilitates regulatory and business planning. With PRIA now suspended, no deadline will apply to any applications filed during the closure, although a reduced fee will still apply. It is highly unlikely that many parties will continue with filings during this period, as there can be no estimate of when EPA might complete processing of the application.

A resolution of the closure will likely include the enactment of a new PRIA. Once PRIA is again operative, EPA will likely see a wave of applications filed, putting any application not subject to PRIA in further uncertainty. Depending upon EPA’s position on these applications once business resumes, parties who filed during this period of ambiguity may want to consider refiling in order to become subject to the new PRIA.

© 2019

Compliance Date Fast-Approaching for Revisions to Minimum Risk Pesticide Labeling

In a Final Rule published on December 28, 2015, EPA has revised its regulations to more clearly describe the active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption (40 CFR 152.25(f)). EPA is doing this by codifying the inert ingredients list and reformatting the active and inert ingredients lists, adding specific chemical identifiers (through the use of Chemical Abstracts Service Registry Numbers), where available, for each eligible active and inert ingredient.

In addition, labeling requirements for minimum risk products have been revised so that producers of these products must list designated label display names of ingredients and producers must provide contact information on product labeling. The compliance date for the revised label requirements is February 26, 2019. In anticipation of this date, some states that require registration are expecting revisions to labels to be completed and submitted with a producer’s 2019 renewal. 

We assist our clients with reviewing and updating minimum risk labeling and registering minimum risk pesticide products with state agencies. Please contact us if you need our assistance with ensuring your labels comply with new regulations and if you need assistance in submitting updated labels to states that require registration. https://enviroreg.com/contact-us/

© 2019

EPA Extends the Registration of Dicamba on Dicamba-tolerant Crops for Certain Applications

The U.S. Environmental Protection Agency (EPA) announced on October 31, 2018, that it is extending the registration of dicamba until December 20, 2020, for “over-the-top” use to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. This extension was made in response to EPA’s review of new information and thus determined that the continued registration of these dicamba products meets FIFRA’s registration standards and using these products under the new safety measures will not affect endangered species.

To ensure products can be used effectively and safely around sensitives crops and other plants, the following restrictions were made for the 2019-2020 growing season:

• Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications)
• Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting
• For cotton, limit the number of over-the-top applications from 4 to 2 (soybeans remain at two over-the-top applications)
• Applications will be allowed only from 1 hour after sunrise to 2 hours before sunset
• In counties where endangered species may exist, the downwind buffer will remain at 110 feet, and there will be a new 57-foot buffer around the other sides of the field (the 110-foot downwind buffer applies to all applications, not just in counties where endangered species may exist)
• Clarify the training period for 2019 and beyond, ensuring consistency across all three products
• Enhanced tank cleanout instructions for the entire system
• Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba
• Label clean up and consistency to improve compliance and enforceability

For more information, see: https://www.epa.gov/ingredients-used-pesticide-products/registration-dicamba-use-genetically-engineered-crops

© 2018

EPA Releases Draft Atrazine Human Health Risk Assessment for Public Comment

EPA’s Office of Pesticide Programs has released for public comment Atrazine Draft Human Health Risk Assessment.

To support Registration Review for atrazine, the Health Effects Division has evaluated the hazard and exposure data and conducted dietary, residential, aggregate, and occupational exposure assessments to estimate the risk to human health that will result from the registered uses of pesticides.

The Draft Risk Assessment includes updates to neuroendocrine effects using PBPK modeling and to drinking water exposure assessment; and completion of aggregate exposure assessments, non-occupational spray drift exposure assessment, and an occupational exposure assessment.

You may submit comments to EPA by September 24, 2018: https://www.regulations.gov/comment?D=EPA-HQ-OPP-2013-0266-1161 

© 2018

 

EPA Webinar seeking input on developing product testing strategies on Hospital Disinfectants

The EPA plans to host a webinar June 21st between 1-3 p.m. ET to focus on the effectiveness of disinfecting agents in hospitals. The EPA is seeking input from registrants of antimicrobial products and laboratory personnel with efficacy testing responsibilities. Additional details on the webinar can be found here. To register for the webinar, you can follow this link.

After the webinar, the docket EPA-HQ-OPP-2018-0265 at www.regulations.gov will be open for comments.

 

© 2018