New York Announces Administrative Elimination 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.

 

EPA Seeks Public Comment on Pending Applications to Amend Existing Registrations to Add Hemp as a Target Site  

On August 23, 2019, the U.S, Environmental Protection Agency (“EPA”) published a notice seeking public comment on ten pending applications to amend existing registrations of agricultural pesticides to add hemp as an approved target site. See 84 Federal Register 44296 (August 23, 2019)

Interest in hemp has grown enormously since the enactment of the Agriculture Improvement Act of 2018, colloquially known as the Farm Bill. Hemp is simply another term for the cannabis plant, also known as marijuana. The Farm Bill legalized the cultivation of and interstate commerce in hemp, defined as the cannabis plant containing less than 0.03 % THC [delta-9-tetrahydrocannabinol; the psychoactive constituent of cannabis]. Plants containing above 0.3% THC remain classified as an illegal Schedule 1 drug under the Controlled Substances Act.

The legalization of what is also known as industrial hemp has been greeted with great interest by the agricultural community. In some areas, such as upstate New York, hemp is seen as an alternative crop that might help save failing dairy farms. It is also seen as a natural corollary to increased cultivation of hops to meet the demands of the burgeoning craft brewery industry.

EPA has received applications to amend the registrations of ten products from three registrants:  Agro Logistic Systems, Inc. of Diamond Bar, California; Marrone Bio Innovations of Davis, California; and Hawthorne Hydroponics of Santa Rosa California. Hawthorne Hydroponics is a subsidiary of Hawthorne Gardening, itself a subsidiary of Scotts Miracle-Gro. Hawthorne is Scott’s vehicle for creating a space servicing the cannabis industry.

The ingredients in question are mostly biologic pesticides, and all hold exemptions from the requirement for a food tolerance. The proposed use patterns are within those already approved for the products in question.

EPA acknowledged that these proposed amendments do not meet the minimum standards of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) for required public notice of pending applications. Nonetheless it stated that sufficient public interest in hemp justified seeking public comment at this initial stage, but would not continue to publicize the increasing number of applications which it expects to receive.

Comments are due September 23, 2019, and can be filed at www.regulations.gov

 

 

 

EPA Denies Chlorpyrifos Cancellation Petition; Six States File Challenge in 9thCircuit  

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 is again being challenged in Court by a collection of states, while California is moving ahead to administratively cancel all registration and New York awaits the Governor’s decision on whether to sign legislation phasing out all use.

Petition to Cancel EPA Registrations

A Petition to Cancel the registration of chlorpyrifos 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 March 29, 22017 EPA denied the Petition (See 82 Fed. Reg. 16581) although it expressly reserved decision on several issues. EPA stated that those issues would be addressed in registration review, due to be completed by 2022. Petitioners sought to overturn the denial by filing a Petition for Review in the 9thCircuit U.S. Court of Appeals. On April 19, 2019, the Court had ordered EPA to respond to the merits of the Petition within 90 days.

On July 24 EPA published its final order denying all aspects of the Petition.  EPA contends that the science addressing the risks of chlorpyrifos remains uncertain, and thus there is no legal basis for canceling the registrations and revoking the tolerances. One particular point of contention is 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.

In response to the Petition denial, six states – California, Maryland, Massachusetts, New York, Vermont and Washington – have again filed a Petition for Review in the 9th Circuit U.S. Court of Appeals.

California and New York Direct Actions

Following up on its earlier announcement, the California Department of Pesticide Regulation (“CDPR”) on August 14, 2019 issued cancellation notices to all California chlorpyrifos registrants. CDPR expressly states that its decision is based upon data from five animal studies. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.  On the same day CDPR also appointed an Alternatives to Chlorpyrifos Workgroup to address the ramifications of the withdrawal of chlorpyrifos from the market.

In New York, the legislature has 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.

The Legislature has yet to send the passed bill to the Governor. Once the bill is transmitted to the Governor, the bill must be signed within thirty days, or it will automatically lapse in a so-called “pocket veto.” 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 to a legislative action.

 

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, also 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. 3d 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 54,000 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.

 

 

U.S. Supreme Court Grants Review of Emerging Clean Water Act Liability Theory

As anticipated, on February 19, 2019 the U.S. Supreme Court acted as recommended by the U.S. Solicitor General (“SG”) and granted certiorari in one of two Clean Water Act (“CWA”) citizen suits for which Petitions for Certiorari were pending, Hawaii Wildlife Fund v County of Maui, 886 F 3d 737[9th Cir.; March 30, 2018].

The CWA requires a permit under the National Pollutant Discharge Elimination System (“NPDES”) or a state counterpart program for any discharge of a pollutant from a point source into the waters of the United States. A typical NPDES permit circumstance involves a pipe discharging pollutants directly into the waters of the U.S. The emerging theory is that pollutant discharges from a point source that travel through the ground to reach the waters of the U.S., rather than being discharged directly into U.S. waters, also violate the CWA.  This application of the CWA is termed the “conduit” theory. EPA’s position has been that CWA jurisdiction does extend to pollutants traveling through the ground only if a direct hydrologically connection to the waters of the U.S. can be demonstrated.

The County of Maui operates injection wells into which it discharges treated wastewater.  It is undisputed that the treated water constitutes a pollutant and that it can be traced and shown to be reaching the Pacific Ocean. In Hawaii Wildlife Fund v County of Maui, 886 F 3d 737[9thCir.; March 30, 2018] the Court upheld a District Court decision finding a violation of the CWA on the theory that a discharge into the waters of the U.S. that was first injected into the ground and then migrated into the Pacific Ocean can still be characterized as originating from a point source, notwithstanding the lack of a direct discharge from the point source to the waters of the U.S. The County then filed a Petition for Certiorari.

Although in submitting the recommendation to grant certiorari the Solicitor General did not take position on the merits of the case, it is anticipated that the U.S. will support the County and oppose the conduit theory.  In its amicus brief the Solicitor’s office stated that EPA would soon be issuing guidance on this topic, but so far no guidance has been issued.

Given the timing of the grant within the 2018-2019 term, this matter will not be heard until the 2019-2020 term. Extensive amicus participation is anticipated.

 

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 the pesticide 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.  It provided reasonable certainty to a system that previously was 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 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.