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 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 was retroactive to December 21 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 within pesticide program, one certainty is that acknowledgements of pesticide notifications are likely to be very long in coming. Given that certain states require require EPA confirmation of notifications, this logjam is likely to cause certain product changes to take months to implement.

Confirmation of EPA Assistant Administrator Prompts Announcement of Pesticide-Related Policy Developments, Including the Worker Protection Standard and Applicator Certification Rule

The U.S. Senate recently confirmed the appointment of Alexandra Dunn as Assistant Administrator for Office of Chemical Safety and Pollution Prevention (“OCSPP”) at the U.S. Environmental Protection Agency (“EPA”). Ms. Dunn had most recently been a Trump appointee as EPA Regional Administrator for Region 1, based in Boston.

During Ms. Dunn’s confirmation process Senator Thomas Carper of Delaware raised issues related to the Agency’s regulation of chemicals, including the approach to the use of science in regulation. Most of the emphasis was on the Toxic Substances Control Act (“TSCA”) and the implementation of the related Frank Lautenberg Chemical Safety Act for the 21st Century. However, several significant pesticide policy issues were also raised, including use of science in reviews of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), as well as regulatory issues related to worker protection and applicator certification. The Agency set forth its position on these issues in a letter from Acting Administrator Wheeler to Senator Carper.

On the science front, at issue was the science policy regulation proposed by OCSPP last April. See 83 Federal Register 18768 (April 30, 2018). The proposal, entitled “Strengthening Transparency in Regulatory Science” The stated overall aim of the proposal was to “ensure that the data and models underlying scientific studies that are pivotal to regulatory action are available to the public.” This change was proposed notwithstanding the fact that multiple Courts have found EPA’s existing practices in relying science to be legally acceptable. See American Trucking Associations v EPA, 283 F.3d 355 (2002.)

In fact the proposal raised significant alarm in the scientific community. Concern was expressed that rather than promoting sound science, the proposal would undermine EPA’s reliance on science because it would rule out otherwise valid studies whose underlying data was confidential. See for example a letter from the editors of four major journals, who objected to the proposed policy and EPA’s assertion that the policy was in line with the policies of the journals in question. http://science.sciencemag.org/content/360/6388/eaau0116 Acting Administrator Wheeler has now committed to having the proposed policy reviewed by the National Academy of Science. Although the outcome of such a process will be somewhat influenced by the charge which is given to the NAS in referring the issue, many critics are likely pleased by this outcome.

In the same exchange policy changes were also announced with respect to pesticide Worker Protection Standards and applicator certification rules. EPA had spent several years developing a new certified applicator rule, which was promulgated on January 4, 2017. See 82 Fed. Reg. 952.
The most controversial aspect of the rule changes was the imposition of a nationwide requirement that person applying restricted use pesticide must be at least 18 years of age. Notwithstanding an exemption for family members under 18 applying pesticides under the supervision of a family member, agricultural interests still pushed back on the age restriction. As a result EPA had proposed extending the effective date of the rule and reconsidering the age restriction. See 82 Fed. Reg.60196 (December 19, 2017). Mr. Wheeler has now announced that EPA will withdraw its proposed revisions from the Office of Management and Budget, and will not lower the age restriction nor designated representative provisions, another controversial aspect of the worker protection rule. Wheeler did state that there may reconsideration of the application exclusion zone (AEZ”) aspect of the worker protection rule, but if so would do so through a public notice and comment process.

Recommendation of U.S. Solicitor General Increases Likelihood of U.S. Supreme Court Review of Emerging Clean Water Act Liability Theory; EPA to Issue Related Guidance in Coming Weeks

On January 4, 2019, in response to a Call for the View of the Solicitor General (“CVSG”) issued by the Supreme Court, the U.S. Solicitor General (“SG”) filed an amicus brief recommending that the Supreme Court grant certiorari in one of two Clean Water Act (“CWA”) citizen suits for which Petitions for Certiorari are pending. In the suits, one of which originated in South Carolina and the other in Hawaii, the U.S. Circuits Courts for the 4th and 9th Circuits respectively held that a party is liable under the CWA for releasing pollutants from a point source which travel through the ground and reach the waters of the U.S.

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. 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 [9th Cir.; 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 has filed a Petition for Certiorari.

Two other Circuit Courts have addressed the issue and arrived at opposite conclusions. In Upstate Forever v. Kinder Morgan Energy Partners LP, 887 F 3d 637 [4th Cir. April 12, 2018] the Court concurred with the analysis in Hawaii and held that gasoline spilled from a pipeline and continuing to leach into the waters of the U.S. was a CWA violation. The 6th Circuit in Kentucky Waterways Alliance v. Kentucky Utilities Company, F. 3d 925 [6th Cir.; September 24, 2018] expressly disagreed with the Hawaii and Upstate Forever decisions. Kinder Morgan has also filed a Petition for Certiorari.

A CVSG is a discretionary action of the Supreme Court through which the Court solicits the official view of the United States in cases in which the U.S. is not a party. Essentially the U.S. becomes an officially-invited amicus curiae, or friend of the Court. A vote of the Court is required to issue a CVSG, which typically occurs in only approximately ten cases a term.

The SG urged the Court to accept the Hawaii case but not the Kinder Morgan case, and to address only the single issue of whether a discharge into the waters of the U.S. that was first released on or into the ground and which then migrated into the waters of the U.S. 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. Each case raised ancillary issues, which is why the SG recommended that only the Hawaii case be accepted and the issues to be addressed be limited to the primary substantive issue.

Although it could have, the SG did not take a position on the merits of the case. The SG pointed out that in February, 2018 EPA sought public input on whether the CWA should be interpreted as the citizen plaintiffs in these cases have alleged. In its brief the SG revealed that EPA will in the “next several weeks” issue a response on the issue, which the SG asserted could be taken into consideration if the Court accepts the case.

This recommendation significantly increases the likelihood that the Court will do so and thereby decide whether an emerging theory of liability is a correct interpretation of the CWA. Out of the thousands of Petition for Certiorari that are filed each year, the Court grants approximately 0.9% of them. In the case of so-called “paid Petitions” such as these, where the parties have not sought pauper status, the rate increases to approximately 42%, meaning the Court is 47 times more likely to grant the Petition. Put differently, the Court follows the SG’s recommendation almost 80% of the time.*

Bottom line: expect the Court to grant certiorari.

*Statistics excerpted from “An Empirical Analysis of Supreme Court Certiorari Petition Procedures: The Call for Response and the Call for the Views of the Solicitor General” appearing in the George Mason Law Review, Vol 16, at 237 [Winter 2009]

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 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.

Supreme Court Decision Opening Door to Sports Wagering Offers No Precedent for Marijuana Legalization

With the Supreme Court striking down the Professional and Amateur Sports Protection Act (“PASPA”), the ruling opens the way for states to legalize sports betting. In wake of the ruling, many news organizations have been quick to compare how this ruling might affect future state legalization of cannabis. While on the surface the legal posture on each issue appears to share commonalities, the legislative differences mean this decision offers no route to state cannabis legalization.
To understand the differences between the two legislative efforts, one must understand the difference between Federal statutory directions to state versus private actors. As the name suggests, state conduct refers to state actions while private conduct refers to the actions of individuals. PASPA controlled state conduct, forbidding states from legalizing sports betting. The Supreme Court ruling on PASPA rested on the “anti-commandeering” principle, which dictates the Federal government is constitutionally precluded from dictating state conduct. Since there are no Federal statutes that contain a prohibition for private conduct on sports betting, legislatively state legalization on sports betting will face no impediment.
In the case of cannabis, there are multiple Federal laws that make private cannabis-related conduct illegal, rendering the PASPA legislative ruling fundamentally different. Due to these multiple Federal laws prohibiting cannabis-related private conduct, even if states move to authorize legislation legalizing cannabis-related private conduct, Federal criminal laws would still prohibit its criminal use.

Syngenta Agrees to $550,000 EPA Pesticide Worker Protection Enforcement Settlement

Syngenta Seeds LLC (“Syngenta”), a subsidiary of Swiss agrochemical company Syngenta, reached a settlement with the EPA for violations of The Federal Insecticide, Fungicide, Rodenticide Act (“FIFRA”) Worker Protection Standard. In a Consent Agreement and Final Order (CAFO) document, Syngenta agreed to a civil penalty of $150,000 and to implement a Supplemental Environmental Project (SEP) costing no less than $400,000.

The administrative complaint filed against Syngenta alleged that seasonal workers were exposed to chlorpyrifos and permethrin before the restricted entry interval (REI) of 24 hours had passed, were not warned by Syngenta employees before entering, and were not properly decontaminated after the incident. Exposure events occurred on two occasions in 2016 and 2017. The matter came to EPA attention through a worker reporting adverse reactions after working in the Syngenta field. The complaint goes further stating that the warning sign that notifies workers of pesticide applications was folded up, obscuring its full view from the workers and Syngenta employees failed to verbally inform the workers to not enter the restricted areas.

The resulting SEP will develop and help promote use of Worker Protection Standard (WPS) Compliance Kits, and train employees on how to comply with FIFRA Worker Protection Standards. Due to most of the violations occurring in-house, the SEP will focus on training Syngenta’s full-time employees. While the CAFO does not explain how the EPA came to the $400,000 figure, it explicitly notes the $400,000 “shall not include the following categories of Respondent’s costs: Respondent’s overhead, Respondent’s additional employee time and salary, Respondent’s administrative expenses, Respondent’s legal fees, and Respondent’s costs of oversight of the contractor who will develop and implement the SEP.” More details of the CAFO can be found here.

04/03/2018

© 2018

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.

Budget Bill Continues Protection of State Medical Marijuana Programs

The budget bill which passed the House on March 22 contains the Rohrabacher (R-CA)-Blumenauer (D-OR) amendment, which prohibits the expenditure of Federal funds to take any enforcement action against anyone acting in compliance with a state medical marijuana program. Enactment by the Senate and signing by the President is anticipated. Assuming enactment the protection will continue until September 30, 2018, the end of the Federal fiscal year. Efforts by the Colorado delegation to extend protection to state recreational marijuana programs failed.