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.

Wednesday, May 18, 2022
12:00 p.m. - 1:00 p.m. (EDT)

Register Today

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.”

Topics Covered:

  • Achieving sustainability and the promise of the circular economy
  • Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act
  • Federal policy and Toxic Substances Control Act (TSCA) regulatory shifts intended to support sustainability and circularity
  • Transitioning chemicals from research and development (R&D) platforms into the market
  • Changes to TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that affect chemical innovation

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.

Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University

Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.

Register Now


 

Bergeson & Campbell, P.C.’s (B&C®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as they discussed key OPP developments and priorities.
 
With year one of the Biden Administration’s term in the history books, EPA OPP is focusing on long-standing challenges, especially EPA-wide efforts to implement Environmental Justice (EJ) work and determining how best to meet core pesticide registration review obligations in 2022. During this webinar, Messina spoke about the recently released Endangered Species Act (ESA) Workplan, chlorpyrifos and dicamba developments, pesticide product performance data requirements, and per- and polyfluoroalkyl substances (PFAS) issues, as Aidala followed up with questions informed by his many years of experience in senior positions at EPA.
 
We encourage you to view the webinar, subscribe to B&C’s informative FIFRAblog™ and pesticide newsletter, and access more pesticide development news directly from OPP on its website.


 

By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.

Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.

EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.

If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.

EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.

Commentary

This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.

This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.

Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.

In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.

For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.


 

By Lisa R. Burchi and Barbara A. Christianson

On December 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it released the registration review schedule for the next four years through fiscal year (FY) 2025. While historically this schedule has been updated once each year, EPA states that going forward it will be updated on a quarterly basis.

The 2007 amendment of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that EPA review each registered pesticide at least every 15 years. For the 726 pesticide cases that were registered before October 1, 2007, the amendment to FIFRA requires EPA to complete its review by October 1, 2022. This is significant, as it is intended to mark the end of the first 15-year registration review cycle.

Working toward that goal, EPA states that it has completed the following over the past 15 years:

  • Issued more than 550 interim or final decisions;
  • Completed more than 600 proposed interim decisions;
  • Conducted more than 680 human health and ecological draft risk assessments (excluding endangered species assessments);
  • Imposed new risk mitigation requirements for 51 percent of antimicrobial pesticides and 70 percent of conventional pesticides for which EPA issued an interim or final decision; and
  • Canceled some or all uses in 120 cases.

EPA states its updated registration review schedule provides a “roadmap” for the next four years of EPA’s registration review program. EPA’s schedule includes 297 entries describing the registration review “action” (e.g., Draft Risk Assessment, Proposed Interim Decision, Interim Decision, Preliminary Work Plan, Final Work Plan) to be addressed by EPA’s different divisions (e.g., Pesticide Reevaluation Division; Antimicrobials Division, Biopesticides and Pollution Prevention Division). Throughout its review, EPA makes the information, assessments, and supporting material for each case available to the public at regulations.gov.

Significantly, but not surprisingly, EPA acknowledges that for some pesticides registered before October 1, 2007, it “anticipates that its review will extend beyond” the October 1, 2022, deadline “due to a number of challenges including delays in receiving data from registrants; the demands of responding to COVID-19; and a significant increase in recent years of resources devoted to litigation.” EPA also warns that the schedule is “subject to change based on shifting priorities and is intended to be an estimated timeline.” EPA notes further that data that are not submitted on time may affect EPA’s registration review timeline and that “several cases are not found on the schedule due to uncertainty of when necessary data will be received.”

Complying with the Endangered Species Act (ESA) is also part of the registration review process. Since 2007, EPA states that it has completed ESA assessments for certain high-priority pesticides and, in the coming years, plans to assess the effects of many more pesticides on endangered species in registration review. According to EPA, it will release its first ESA pesticides work plan in the coming months, which will outline steps EPA will take to come into compliance with the ESA in ways that are fair and transparent to the agriculture sector.

Information on EPA’s registration review process is available here.


 

By Carla N. Hutton

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.

According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:

  • Focus on improvements that deliver real world benefits for species conservation, public health, and food production. Examples include:
    • Use pilot projects to begin implementing mitigation measures as part of upcoming pesticide consultations and to demonstrate process improvements;
    • Adopt measures early in the pesticide consultation process to avoid, minimize, and offset the effects of pesticide use on ESA-listed species; and
    • Ensure that mitigation measures are effective and practical to implement;
  • Consider opportunities to engage with stakeholders as an interagency body to complement the stakeholder activities of each agency; and
  • Communicate the IWG’s work to stakeholders in a transparent manner.

EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.


 

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.


 
 1 2 3 >