Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On March 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the publication of its Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (Revised Method), a method for conducting Biological Evaluations under the Endangered Species Act (ESA). 

The Revised Method will be used by EPA to evaluate potential risks from pesticides to federally listed endangered and threatened species and to make effects determinations during initial registration and as part of periodic registration review.  The Revised Method allows EPA to include historical usage data that reflects where and how certain pesticides have been applied to make predictions about the future.

The Revised Method includes a three-step process to identify and evaluate the potential risk to endangered species by the assessed pesticide:

Topic Step 1 Step 2 Step 3
Assessment Biological Evaluation Biological Evaluation Biological Opinion
Scale Individual and Field Individual and Field/Landscape/Watershed1 Population and Landscape/Watershed
Determination No Effect/May Affect Not Likely to Adversely Affect/Likely to Adversely Affect No Jeopardy/Jeopardy2

1 Although Step 2 is conducted at an individual level, consideration is given to the likelihood that an exposure and effect will occur. This step considers the proportion exposed across the landscape/watershed and the distribution of exposure among individuals.

2 This is the determination for listed species. The determination for designated critical habitats is “No Adverse Modification/Adverse Modification.”

EPA Administrator Andrew Wheeler stated: “EPA’s improved methodology will better protect and promote the recovery of endangered species while ensuring pesticide registration review decisions are conducted in a timely, transparent manner and are based on the best available science.”

EPA has also released for public comment draft Biological Evaluations for carbaryl and methomyl, which were conducted using the final Revised Method.  If EPA determines a pesticide may affect a listed species or its critical habitat, it must consult with the Fish and Wildlife Service and the National Marine Fisheries Service (the Services).  The Services will then issue a Biological Opinion to determine if the population of a species would be adversely impacted and, if so, propose ways to reduce risks.

Comments on the draft Biological Evaluations are due on or before May 18, 2020.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2020-0090

Commentary

Critics of the new method for doing Biological Evaluations have alleged that the purpose of the changes in this method, and of other recent revisions in ESA procedures, is to reduce the number of formal consultations that must be conducted with the Services.  Such allegations must be evaluated in the context of the severe bottlenecks in the current consultation process created by the limited resources and personnel that are available at the Services to conduct any required consultations and to prepare formal Biological Opinions.  The EPA method for doing Biological Evaluations has always been intended to use worst case assumptions to quickly remove from consideration those pesticides that are unlikely to pose any potential risk to endangered and threatened species, so that the limited resources available for the more extensive assessment triggered by consultation are used efficiently to address the most significant potential hazards.  Worst case assumptions, however, exaggerate the “reasonable worst case” and other more realistic scenarios.  Given the reality of limited review resources, focus on more uncertain risks draws resources away from attention on more certain risks to species.  Eventually the assessment system is expected to include other techniques (example: use of probabilistic models) to refine the analyses to concentrate further regulatory options on the most effective ways to protect species.

The draft BE for carbaryl and methomyl are available here and here.  More information on ESA issues is available on our blog.


 

By Timothy D. Backstrom and James V. Aidala

On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine.  EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register.  EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review.  For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks.  For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA).  Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.

Common Factors for Triazine Risk Assessment

There are several common factors to consider with regard to the triazines risk assessment.  These include:

  1. Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class.  EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
  2. As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species.  Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
  3. EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect.  Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments.   All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP.  The EDSP screening testing has not been completed yet for propazine.

Risk Mitigation Measures

Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.

For atrazine, the PID includes the following measures to mitigate aggregate human risk:

  • Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
  • Require additional personal protective equipment (PPE) and engineering controls for certain uses.
  • Restrict aerial applications to liquid formulations only.
  • Limit backpack sprayer applications to landscape turf to spot treatment only.
  • Prohibit pressurized handgun application to certain commodities.

To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.

For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk.  Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

For simazine, the PID includes the following measures to mitigate aggregate human risk:

  • Cancel simazine use on residential turf.
  • Require additional PPE and engineering controls for certain uses.
  • Limit pressurized handgun applications to certain commodities to spot treatment only.

Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.

Commentary

In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses.  In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes.  An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.


 

By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide feedback. 

The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].”

EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.”  EPA states the revisions are based on: (1) “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; (2) consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; (3) consideration of National Research Council (NRC) recommendations; and (4) “lessons learned during the development of the first three BEs.”

EPA states that the following are major aspects of its proposed revisions on which it is seeking comments:

  • To more accurately represent where and to what extent a pesticide is likely to be applied, EPA is proposing an approach for incorporating pesticide-specific usage data into Steps 1 and 2 of the BEs.  While the pilot BEs relied on use assumptions from pesticide product labels to represent where the pilot chemicals were likely to be applied (e.g., applied to all labeled crops at maximum application rates simultaneously), the Draft Revised Method proposes to incorporate usage data (e.g., survey data, including actual application rates) in the determination.
  • Based on the accuracy of the spatial data utilized and the conservative assumptions related to the action area and potential drift, EPA’s notice states that it is proposing to interpret “a <1% overlap of listed species’ ranges with potential use sites as unreliable and not representative of real exposure potential.”
  • EPA is proposing an approach for introducing components of probabilistic analysis into the BE, as the “goal of the probabilistic analysis is to more fully capture and characterize the variability in the range of potential exposures and toxicological effects to listed species to better inform the biological opinion.”
  • EPA is proposing a weight-of-evidence framework “to distinguish those listed species that are likely to be adversely affected (LAA) from those that are not likely to be adversely affected (NLAA), based on criteria (e.g., dietary preferences, migration patterns, extent of range potentially exposed) associated with the likelihood that an individual will be exposed and affected.”

The June 10 public meeting, which EPA states “is part of the federal government’s coordinated effort to improve the Endangered Species Act (ESA) process that is used when pesticides are federally registered,” will be held from 9:00 a.m. to 12:00 p.m. (EDT) in the lobby-level conference center of EPA’s offices at Potomac Yard South in Arlington, Virginia.  Those wishing to attend either in person or via teleconference/webinar must register by May 30, 2019.  Registration is available online.  Comments on the Draft Revised Method are due by July 1, 2019, in Docket No. EPA-HQ-OPP-2019-0185 on www.regulations.gov.

Commentary

This is the latest chapter in the long saga of coordination between ESA review by the Services and EPA registration activities.  The steps outlined in the Draft Revised Method are designed to improve the coordination of work between the agencies and represent an important step in designing a framework that might make the current situation more reliable, predictable, and efficient.  The current process has been subject to criticism on a number of fronts, with the current BE process seen as unsustainable given the amount of resources and time consumed by the first BEs. 

The goal is eventually to have the Services and EPA “play nice together” and implement a leaner and more efficient process, which is considered absolutely necessary if EPA hopes ever to complete appropriate ESA assessments on hundreds of active ingredients formulated into thousands of end use pesticide products.  Such efforts could also represent a cornerstone of the agencies’ meeting provisions in the 2018 Farm Bill (Section 10115), which includes requirements for the agencies to “… increase the accuracy and timeliness” of the ESA consultation process, as well as implement these same policies stated in the Memorandum of Agreement between EPA, the Department of the Interior, and the Department of Commerce on Establishment of an Interagency Working Group to Coordinate Endangered Species Act Consultations for Pesticide Registrations and Registration Review.


 

By Susan M. Kirsch

On April 12, 2018, House Agriculture Committee Chairman Michael Conaway (R-Texas) released the Committee’s draft Farm Bill reauthorization, the “Agriculture and Nutrition Act of 2018” (H.R. 2). The House Agriculture Committee passed the Farm Bill package on April 18, 2018, setting it up for a floor vote in the House.  The 600-plus page draft legislation includes a number of provisions that will be of interest to pesticide registrants and the pesticide user community, including the following sections:

  • Section 9119. Enactment of Pesticide Registration Improvement Act of 2017: This provision would enact the Pesticide Registration Improvement Extension Act (known as PRIA-4), which authorizes the U.S. Environmental Protection Agency (EPA) to continue to collect $40 million in registration and maintenance fees critical to supporting the pesticide registration process.
  • Section 8303. Consultation under the Endangered Species Act (ESA): Subsection (a) would eliminate ESA Section 7 consultation requirements for U.S. Forest Service projects where a “not likely to adversely affect” determination has been made. Subsection (b) requires ESA Section 7 consultation for forest management activities carried out under the Farm Bill to be completed within a 90-day period.
  • Sections 9117 and 9118. Clean Water Act (CWA) Pesticide Permitting:  Together these two provisions amend the CWA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to eliminate CWA National Pollutant Discharge Elimination System (NPDES) permitting for FIFRA-compliant pesticide applications.  These sections incorporate the regulatory relief language from previously proposed stand-alone bills aimed at eliminating the dual regulation of pesticide applications into, over, and near surface waters, which passed the House in the 115th Congress (H.R. 953) and has been proposed in the Senate (S.340).

The full text of H.R. 2 and a section-by-section summary are available on the House Agriculture Committee Farm Bill webpage along with several related fact sheets.  The Agriculture Committee expects to mark-up the bill this week.


 

By James V. Aidala

On January 31, 2018, Scott Pruitt, the Administrator of the U.S. Environmental Protection Agency (EPA), announced the establishment of an Interagency Working Group to Coordinate Endangered Species Act (ESA) Consultations for Pesticide Registrations and Registration Review.  EPA, the U.S. Fish and Wildlife Service, and the National Marine Fisheries Service (NMFS) (the Services) signed a Memorandum of Agreement (MOA) on the establishment of the working group.  The stated purpose of the working group is that it “will provide recommendations to EPA, FWS, and NMFS leadership on improving the [ESA] consultation process for pesticide registration and registration review (‘pesticide consultation process’) and will ensure that the new process is recorded and formalized as appropriate.”  The working group’s action plan includes the following:

  1. Analyze relevant statutes, regulations, and case law.  The Working Group will review the statutory requirements under ESA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the case law that has developed on the intersection of ESA and FIFRA; and existing regulations for the pesticide consultation process. 
  2. Review past ESA pesticide consultation practices to learn lessons from recent experience and review current and previous pesticide consultation practices to identify problems and areas for improvement, as well as best practices that should be used in future pesticide consultations.
  3. Prepare recommendations to improve scientific and policy approaches to ESA pesticide consultations.  For example, the Working Group will develop a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation.  The Working Group will also help provide clarity as to what constitutes the “best scientific and commercial data available” in the fields of pesticide use and ecological risk assessment, which EPA and the Services are required to use under ESA section 7(a)(2).
  4. To the extent that current authorities and practices do not allow for the timely and accurate review of pesticides consistent with governing authorities, the Working Group may memorialize its recommendations for a revised regulatory framework, including addressing agency responsibilities, recommended technical approaches, and recommendations for new regulations, a memorandum of understanding, or other appropriate documentation. 

Commentary

Like others before them, the Trump Administration is embarking on a journey to address the problem of how to integrate ESA assessment and consultation requirements with the FIFRA registration process.  This directive will help organize a senior level effort to coordinate activities of EPA and the Services and, like past efforts, at the senior management level there will likely be at least a recognition that something needs to be done to fashion a more efficient and predictable process.  Currently ESA reviews add months and years to the registration review process and, to date, that process is followed by seemingly inevitable litigation challenging the EPA decision as not sufficient to meet ESA requirements.

The result has been an exhaustive, time and resource intensive initial set of “pilot” biological opinions, and a very long list of promised consultations resulting from past litigation cases.  Currently, the workload already committed will be virtually unattainable for a number of years, and as EPA plans to have ESA assessments as part of the registration review process for older pesticides (as well as for future new product applications), the budget and staffing implications are staggering.  Meantime, agricultural stakeholders, including pesticide manufacturers and grower groups who use pesticides, fear that the current process might result in the loss or delay in the introduction of needed pest control products.

This is the context for the current attempt to devise an integrated, more efficient process to have any realistic chance to fashion a process which meets the requirements of both statutes.  We wish any and all participants good luck and constant senior political level involvement -- they will likely need much of it.

More information on ESA issues is available on our blog.


 

By Lynn L. Bergeson

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available.  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!


 

By Lisa R. Burchi, Timothy D. Backstrom, and James V. Aidala

On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in Center for Biological Diversity (CBD), et al. v. U.S. Environmental Protection Agency (EPA), Case No. 14-1036, resolving jurisdictional and substantive issues following complaints alleging that EPA violated Section 7(a)(2) of the Endangered Species Act (ESA) by failing to make an effects determination or to consult with the U.S. Fish and Wildlife Service (FWS) or the National Marine Fisheries Service (NMFS) before registering cyantraniliprole (CTP) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Regarding the jurisdictional issue and the appropriate court in which to bring such a challenge, the U.S. District Court for the District of Columbia on May 14, 2015, had dismissed the ESA complaint of CBD, the Center for Food Safety, and the Defenders of Wildlife (Conservation Groups), finding that the Conservation Groups’ “Complaint gives rise to an ‘actual controversy as to the validity’ of the FIFRA Registration Order and is therefore governed by that Act’s jurisdictional grant.”  The D.C. Circuit affirmed the U.S. District Court’s ruling to dismiss the ESA petition on jurisdictional grounds, concluding that FIFRA “grants the court of appeals exclusive jurisdiction to review an ESA claim that is ‘inextricably intertwined’ with a challenge to a pesticide registration order.”

The D.C. Circuit also, however, granted the Conservation Groups’ FIFRA petition, finding that EPA registered CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required under ESA Section 7(a)(2).  The court remanded the case to EPA for further proceedings, but allowed the CTP registration order to remain in effect until it is replaced by an order consistent with the court’s opinion.

Considering the growing number of complaints that allege a failure to consult with the FWS and/or the NMFS under the ESA, this decision could have broad reaching implications for how these complaints are filed and reviewed.

Background

On February 29, 2012, EPA announced that it had received applications to register pesticide products containing CTP under FIFRA.  On June 6, 2013, EPA announced its proposal to register CTP as a pesticide under FIFRA.  As part of its review, EPA prepared an “Environmental Fate and Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole” in which EPA states that CTP is “highly toxic or very highly toxic” to multiple taxonomic groups, including terrestrial invertebrates such as butterflies and beetles.

On January 24, 2014, EPA registered CTP as a pesticide under FIFRA and approved fourteen end-use products containing CTP.  At issue in this case was EPA’s decision to register CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required by ESA Section 7(a)(2) and implementing regulations (50 C.F.R. § 402.13-14).

Under the ESA citizen-suit provision, “any person” may “commence a civil suit on his own behalf … to enjoin any person, including the United States and any other governmental instrumentality or agency … who is alleged to be in violation of any provision of this chapter or regulation issued under the authority thereof.” 16 U.S.C. § 1540(g)(1).  “The district courts … have jurisdiction” of ESA citizen suits, id., but no action may be commenced “prior to sixty days after written notice of the violation has been given to the Secretary, and to any alleged violator.” Id. § 1540(g)(2)(A)(i).

FIFRA’s citizen-suit provision at 7 U.S.C. § 136n(b) provides the federal circuit court with exclusive jurisdiction to affirm or set aside an EPA pesticide registration order following a public hearing, provided a challenge is filed within 60 days of the registration decision.

With potentially conflicting statutory provisions regarding the court in which to file a complaint and the timing to do so, the Conservation Groups initiated two actions:  a complaint against EPA in D.C. District Court under the ESA’s citizen-suit provision; and a petition for review in D.C. Circuit Court pursuant to FIFRA’s citizen-suit provision.

Jurisdictional Issues

The D.C. Circuit first addressed the jurisdiction issue, which involved a determination of standing and a resolution of the “dueling jurisdictional provisions of the ESA and of FIFRA.”

On the issue of standing, the D.C. Circuit found that petitioners did in fact have standing, as not only did EPA make procedural omissions through “its failure to make an effects determination and to consult,” but the plaintiffs show that EPA’s failure affected the plaintiffs’ members’ “concrete aesthetic and recreational interests.” 

With regard to the appropriate court in which to bring this claim, the D.C. Circuit found that “FIFRA vests the courts of appeals with exclusive jurisdiction over controversies arising from an EPA pesticide registration, so long as, inter alia, registration follows a public hearing.”  The court thus also found:

  • Because FIFRA’s grant of exclusive jurisdiction to the court of appeals to review registration orders is more specific than the ESA’s citizen-suit provision, we believe the Conservation Groups must bring their ESA section 7(a)(2) challenge to us if 7 U.S.C. § 136n(b) is satisfied.  And the Conservation Groups do satisfy the requirements of 7 U.S.C. § 136n(b): they are adversely affected by the registration of CTP; they challenge the validity of the CTP registration order based on the EPA’s failure to make an effects determination and to consult; and their challenge comes after a “public hearing” by way of three notice and comment periods.  We therefore have “exclusive jurisdiction” to review their claim under FIFRA and the district court correctly dismissed their ESA citizen suit. (citations omitted).

Merits

While the ESA citizen suit was dismissed, the FIFRA citizen suit remained under the D.C. Circuit’s exclusive jurisdiction and review.  The court found that EPA violated ESA Section 7(a)(2) by registering CTP before making an effects determination or consulting with the FWS or the NMFS.

Significantly, the court decided to remand the case to EPA for further proceedings without vacating the CTP registration.  The court stated that remand without vacatur is appropriate in this case because “[n]otwithstanding the EPA’s failure to make an effects determination and to engage in any required consultation, it did not register CTP in total disregard of the pesticide’s potential deleterious effects; indeed, the Conservation Groups themselves rely heavily on the EPA’s ‘Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole.’”  The court further stated that “allowing the EPA’s CTP registration order to remain in effect until it is replaced by an order consistent with our opinion will maintain ‘enhanced protection of the environmental values covered by the CTP registration order.’”

Commentary

This case is significant in at least two respects and should have implications in other cases being brought under ESA and FIFRA citizen suit petitions.  First, the court provides the same answer concerning the “dueling jurisdictional provisions of the ESA and of FIFRA” as prior decisions in the Ninth Circuit, finding that FIFRA’s jurisdictional grounds take precedence and that the Courts of Appeal have exclusive jurisdiction to review cases claiming ESA violations in the context of an approved FIFRA pesticide registration.  The court found the Conservation Groups’ arguments to the contrary “unavailing,” including but not limited to their argument that the public notice and comment periods that were provided did not constitute a “public hearing” under FIFRA Section 16(b) as well as their argument that the ESA challenge was not “inextricably intertwined” with FIFRA, even though the Conservation Groups were challenging the CTP registration order itself.  It also is significant that the court, while remanding the registration order to EPA for further actions under the ESA, did not immediately vacate the existing CTP registration order.

Some observers of the extensive ESA-FIFRA litigation over recent years wondered whether the CTP registrations would be vacated once challenged for conformity to ESA requirements.  EPA effectively admitted that it did not follow the full consultation process with FWS and NMFS, in this case substituting a relative risk argument that CTP was an improvement that would provide more species protection compared to the compounds it is expected to replace in the marketplace.  The remand without vacatur does not resolve what some have called the “train wreck” scenario, where the need to complete ESA consultation, combined with time and resource constraints at the respective agencies, will result in a virtual freeze on new pesticide product registrations.  The court makes it clear that, if EPA makes an affirmative ESA effects determination for CTP, consultation with the FWS and/or the NMFS must follow.


 

By Susan M. Kirsch

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides in the Federal Register, which applies to discharges of pesticides to waters of the United States.  EPA is requesting comments on the draft permit by March 11, 2016.  This draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP, which will expire on October 31, 2016.  EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs.  Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year.

The draft 2016 PGP retains coverage of the previous pesticide use patterns (mosquito/flying insect; weed and algae; animal pest; and forest canopy), and leaves unchanged the reliance on technology-based effluent limitations (TBELs) to satisfy permit requirements, which require proper maintenance and calibration of equipment along with visual inspections to minimize discharges and meet water quality standards and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements.  The draft 2016 PGP also retains the distinctions in compliance requirements of “For-hire Applicators” and “Decision Makers,” and includes the same requirements for recordkeeping and reporting of adverse incidents.  The draft permit now mandates electronic reporting, which will make Notice of Intent (NOI) and Annual Report submissions public on EPA’s e-reporting website.  The draft permit retains the “joint and several liability” provision that would extend potential legal risks to all parties involved in decision-making and application of pesticides.  In spite of the lack of new or altered provisions, there are some aspects of the draft 2016 PGP that could signal an EPA policy change going forward, and could potentially appear in the final version of the permit.  These areas include:

  • Absence of a definition for “Waters of the U.S.,” which could create confusion as to the scope of jurisdiction;
  • An ongoing Endangered Species Act (ESA) consultation, which could expand the list of requirements included in the final permit;
  • Request for comments on whether water quality-based effluent limitations (WQBELs), such as water quality monitoring and fish tissue testing (i.e., laboratory studies), should be included in the final permit;
  • Request for comments on whether additional information should be included in NOI submissions, including whether the treatment area includes a source water for public drinking water supplies;  and
  • An expanded discussion of required compliance with all other applicable state and federal laws, including FIFRA storage and handling requirements, which could be perceived to attach Clean Water Act liability to a PGP permittee’s violations of FIFRA and other laws.

EPA’s webpage for pesticide NPDES permitting includes links to the draft permit, fact sheet, and Federal Register docket.


 

By Lisa M. Campbell and Timothy D. Backstrom

On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), the U.S. Environmental Protection Agency (EPA) filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor DowAgroSciences LLC (DowAgro) for Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  DowAgro responded to the motion by agreeing that remand is appropriate but opposing vacatur as an effort to circumvent the normal cancellation process, while the petitioners Center for Food Safety, et al. (CFS) filed a response supporting the motion for vacatur.  More information on the DowAgro and CFS responses is available in our blog entry DowAgro and Center for Food Safety File Responses to EPA’s Motion for Voluntary Vacatur and Remand.

In its reply, EPA rejects the argument by DowAgro that it is trying to “short-circuit” the normal cancellation procedures under FIFRA.  Citing recent Ninth Circuit precedent on vacatur, EPA argues that “vacatur would be more protective of the environment during the time in which EPA evaluates the new information, and Dow has failed to demonstrate any disruptive consequences of vacatur.” 

EPA also takes issue with certain statements by CFS that it characterizes as “erroneous or irrelevant.”  EPA contradicts assertions by CFS that EPA overlooked important evidence concerning the synergistic effects of Enlist Duo’s principal ingredients, that EPA determined that Enlist Duo will not protect endangered non-target plants, that EPA has violated the ESA, and that EPA is approaching synergistic effects as a new issue.  EPA also objects to the efforts of CFS to introduce an extra-record newspaper article.

This case will continue to be watched closely, as there is widespread industry concern about EPA’s effort to use a judicial process in lieu of normal adjudicatory procedures and about EPA’s substantive approach to evaluating synergistic efficacy data.  In this regard, it is noteworthy that the issue of potential synergistic effects is relatively narrow and does not appear to be among the purported deficiencies in the EPA decision originally cited by the petitioners. 


 

By James V. Aidala and Margaret R. Graham

On December 11, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated:  chlorpyrifos, diazinon, and malathion.  For each chemical, the following supporting documents are now available:  problem formulation; fate and effects characterizations; and related appendices.  The provisional models are available here

EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process.  The entire draft biological evaluations for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016

These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions on endangered and threatened species and their critical habitats, and provided recommendations.

USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns.  The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017.

Commentary

This is the opening blow for developing the next round of the EPA-Services’ Endangered Species Act (ESA) assessment process.  This bolus of information, in the range of 30,000 pages, is the EPA part of the assessment process -- now to be examined by the Services to become the complete ESA assessment of the pesticide products and their possible impact.

It is less clear what these extensive efforts will achieve; in essence, it is likely to indicate little more than “everything affects everything.”  On the other hand, it will provide information useful to indicate where the greatest risks to certain species in specific habitats may lie.  Separately, the mere volume of the information and the amount of effort needed to produce it presents a daunting prospect for the ability of the government agencies (EPA and the Services) to further refine the process into anything resembling a timely and efficient process (not to mention the implications for any public review of the information or associated regulatory conclusions).


 
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