vvEPA
Balancing Wildlife Protection and
Responsible Pesticide Use:
How EPA's Pesticide Program Will Meet
its Endangered Species Act Obligations
2022
www.epa.gov/endangered-species
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Table of Contents
3 EXECUTIVE SUMMARY
8 INTRODUCTION
15 A VISION OF SUCCESS
18 BACKGROUND AND CHALLENGES TO VISION
Large and growing workload
26 Lack of process for identifying and requiring practical and timely mitigation
29 FIFRA actions create unique challenges for ESA consultations
Incorporating ESA requirements into the current FIFRA process presents
unique challenges
Challenges related to data and risk assessment tools
36 Need to continue improving the working relationship among agencies
37 STRATEGIES AND ACTIONS TO ADVANCE VISION
41 STRATEGY 1: MEET ESA OBLIGATIONS FOR FIFRA ACTIONS
45 Meet court-enforceable ESA deadlines
45 Meet ESA obligations for new registrations for conventional pesticide ingredients
47 Meet ESA obligations for conventional pesticide ingredients already registered
or undergoing registration review
50 Meet ESA obligations for new use registrations, section 18 emergency use
registrations, and other actions existing conventional pesticides
51 Meet ESA obligations for antimicrobial and biopesticide registration and
registration review decisions
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STRATEGY 2: IMPROVE APPROACHES TO ESA MITIGATION
Identify and incorporate early mitigation for vulnerable ESA species
Focus pesticide consultation process on adopting mitigation for species
likely to receive a jeopardy or adverse modification determination
Identify flexible mitigation for all ESA species
Coordinate mitigation between registration and registration review decisions
Use compensatory mitigation (offsets) to supplement avoidance
and minimization
Pursue other policy and program improvements that support mitigation
STRATEGY 3: IMPROVE INTERAGENCY CONSULTATION PROCESS
STRATEGY 4: IMPROVE STAKEHOLDER ENGAGEMENT
Obtain data for ESA assessments
Expand engagement with growers through USDA
Expand engagement with non-agricultural organizations
CLOSING AND FUTURE STEPS
APPENDIX A
Current schedule for ESA determinations and implementation of NMFS salmonid
biological opinions
APPENDIX B
Pending ESA litigation alleging failure to make effects determinations on FIFRA actions
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EXECUTIVE SUMMARY
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EXECUTIVE SUMMARY
Background
EPA has both an opportunity and a responsibility to address the decades-old challenge of how its
Pesticide Program meets its obligations under the Endangered Species Act (ESA). In past decades, the
Agency has met those obligations for less than 5% of the thousands of pesticide actions it completes
annually under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The reasons for this failure are multifold, including the unusual complexity of ESA pesticide reviews.
The entire process, including consulting with federal wildlife agencies to adopt protections, can take at
least 4 years for a single pesticide and up to 15 years in rare cases. FIFRA requires that EPA reevaluate
every pesticide every 15 years, including the hundreds that affect species listed under the ESA. ESA
obligations also exist for many registrations of new pesticides, new uses of existing pesticides, and
amendments to pesticide labels. In total, thousands of FIFRA actions will require an ESA review over
the next decade alone.
EPA's Pesticide Program has been unable to keep pace with its ESA workload, resulting not only in
inadequate protections for listed species but also litigation against the Agency that has increased in
frequency in recent years. EPA has faced over 20 lawsuits, covering over 1,000 pesticide products,
challenging its failure to meet ESA obligations. As a result, EPA's current ESA priorities are driven
almost entirely by litigation settlements and other court-enforceable deadlines. Over the next six years,
existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides—
the most the Agency estimates it can handle during this period based on its current capacity and
processes. And ongoing litigation and settlement discussions for other lawsuits cover dozens of
additional pesticides and will likely fill the Agency's ESA workload beyond 2030. Even though these
litigation deadlines have determined most of the ESA workload for the next decade, that workload is
estimated to cover less than 5% of EPA's future pesticide actions that trigger ESA obligations. Because
the Pesticide Program currently lacks the capacity and efficient processes to fully meet its ESA
obligations on those remaining pesticide actions, it remains vulnerable to additional lawsuits.
This situation creates significant uncertainty for farmers, other pesticide users, and pesticide
registrants. For example, if a court vacates a pesticide action, users may lose access to the pesticide
for the several years likely needed for EPA to meet its ESA obligations for that action. Without certain
pesticide products, farmers could have trouble growing crops that feed Americans and public health
agencies could lack the tools needed to combat insect-borne diseases.
EPA's Pesticide Program is at a critical juncture and needs a new vision. This is why the Agency has
embarked on an unprecedented effort to improve the current ESA-FIFRA process in collaboration with
the U.S. Fish and Wildlife Service (FWS), National Marine Fisheries Service (NMFS), U.S. Department of
Agriculture (USDA), Council on Environmental Quality (CEQ), and stakeholders especially environmental
and agricultural ones. In the last year alone, EPA has taken several important steps. This includes
deciding to meet ESA obligations when registering new conventional pesticides, incorporating
mitigation for ESA species much earlier in the FIFRA process for certain pesticide decisions, and
revitalizing the ESA-FIFRA Interagency Working Group. This workplan is another important step,
reflecting the Agency's most comprehensive thinking to date on how to improve its ESA-FIFRA work to
meet its mission of protecting human health and the environment while supporting responsible use of
pesticides for agriculture, public health, and other important purposes.
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A Vision of Success and Challenges to the Vision
To guide its ESA-FIFRA work, EPA has developed a vision of a successful process. Success means
that EPA is protecting ESA species and their habitats from pesticide effects to an extent that fulfills
its obligations under all federal laws. EPA would be achieving this goal while minimizing impacts
to pesticide users, supporting the development of safer technologies to control important public
health and agronomic pests, and completing timely pesticide registration decisions. EPA would
also become a trusted expert in protecting listed species through its pesticide decisions, using real-
world, up-to-date information.
To achieve this vision, EPA has identified at least six key challenges that must be overcome.
¦ First is the large and growing number of FIFRA actions that trigger ESA review, at a time
when the Pesticide Program's staffing is roughly at the FY 2013 level.
¦ Second is that the current ESA-FIFRA process generally does not result in protections for
listed species that is both practical for pesticide users to implement and timely to protect
species.
¦ Third is that FIFRA registrations are often geographically broad, cover many pesticide
uses, and affect many types of listed species. All of this creates unique scientific and other
challenges for EPA's ability to meet its ESA obligations.
¦ Fourth is the need to better harmonize the FIFRA process with the ESA process. For example,
the current FIFRA process assesses each pesticide on a chemical-by-chemical basis, but this
approach is unsustainable across hundreds of pesticides, many of which affect hundreds of
listed species. This is one reason that the entire ESA-FIFRA process currently spans at least
4 years for one pesticide.
¦ Fifth is a series of challenges related to data and scientific methods. For example, better
and more refined data on where species occur and how best to protect them from pesticide
exposure would result in more effective and cost-efficient protections. But gathering and
analyzing these data would likely extend the ESA-FIFRA process even longer and require
additional agency capacity. Thus, EPA needs to balance the benefits of more or better data,
with the goal of expediting the ESA-FIFRA process.
¦ Finally, an effective ESA-FIFRA process requires strong working relationships among EPA,
FWS, NMFS, and USDA. All four agencies are working toward this goal but still have room for
improvement.
Strategies and Actions to Achieve Vision
To address these challenges and advance EPA's vision, the workplan establishes four overlapping
strategies and multiple actions to implement each strategy. The first strategy is for EPA to meet its
ESA obligations for all FIFRA actions. Because EPA cannot meet all these obligations immediately
while also complying with statutory deadlines for FIFRA actions, the Agency will generally prioritize
those actions as follows:
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¦ The top tier includes actions with existing and future court-enforceable deadlines and the
registrations of new conventional pesticide active ingredients,
¦ The second tier includes the large number of remaining conventional pesticides, without court-
enforceable deadlines, that EPA reevaluates every 15 years (i.e., FIFRA registration review).
¦ The third tier includes all other FIFRA actions for conventional pesticides [e.g., new uses of
existing pesticides) and FIFRA actions for non-conventional pesticides (e.g., biopesticides).
The workplan provides EPA's rationale for these priority categories and the estimated number of
actions in each category that may require an ESA review.
The second strategy is for EPA to improve its approaches to identifying and requiring ESA protections to
address pesticide effects. These improvements will include the following:
¦ Identify and incorporate protections for ESA species earlier in the FIFRA process, with a focus on
species that EPA considers vulnerable to pesticides.
¦ Proactively adopt protections for ESA species facing the greatest risk to their survival from
pesticides, such that if EPA did not adopt those protections, the Agency may be in violation of
the ESA's substantive obligations.
¦ Identify flexible options for pesticide users to decide how best to protect ESA species affected
by pesticides, including through a federal pilot project being launched in 2022 to identify and
implement practical conservation practices across approximately two-dozen listed species.
¦ Where multiple pesticides are used for the same crops and affect the same species, begin
coordinating species protection measures across those pesticides to ensure the measures
are consistent. In 2022, for example, EPA will begin coordinating opportunities between newly
registered pesticides and existing pesticides undergoing their periodic 15-year reevaluation.
¦ Where pesticide effects on ESA species cannot be practically avoided or minimized, create
opportunities to offset the residual effects through habitat restoration and other conservation
actions. Doing so can provide greater flexibility for pesticide users and directly further species
recovery, especially in response to climate change.
¦ Adopt other policy and program improvements to support the above actions.
The third strategy is to improve the efficiency and timeliness of the ESA-FIFRA process, in collaboration
with FWS, NMFS, and USDA. This strategy includes developing different approaches for EPA to meet its
ESA obligations, which may include assessing all pesticides intended for a particular use at the same
time, and consulting with FWS or NMFS regional staff to efficiently incorporate more localized data on
species, protection measures, and pest control practices.
The final strategy is to improve EPA's stakeholder engagement. This will include seeking help on
more or better data for ESA assessments and expanding dialogues with growers and non-agricultural
pesticide users.
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Closing and Future Steps
The workplan is a living document that will evolve based on lessons learned through
implementation. Within the next two years, EPA will reevaluate its progress under the workplan and
decide whether and how to update it. EPA cannot achieve most of the actions in the workplan on
its own. The Agency welcomes stakeholder feedback on the workplan, especially on opportunities
to help implement species protection measures and provide better data to expedite ESA-FIFRA
analyses.
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INTRODUCTION
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INTRODUCTION
EPA's mission is to protect human health and the environment. The Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA) are important laws that allow
EPA to meet its mission of protecting the environment. Through these and other laws, EPA decides
how best to regulate pesticide uses to ensure they achieve society's pest control goals without
unduly harming human health or the environment, including ESA-listed endangered and threatened
species. This is a formidable task, considering the tens of thousands of pesticide products and
amendments that will require ESA review in the coming decade, combined with the over 1,600
listed species in the United States. Moreover, information on the vulnerability, biology, and location
of many of these species is limited, especially information on how pesticides may impact their
survival. These and other challenges are partly why EPA's Pesticide Program has struggled for
decades with meeting its ESA obligations. Even though EPA has approved over 1,000 pesticide
ingredients and thousands of pesticide uses over the past decades, it has met its ESA obligations
for less than 5 percent of those actions.
This low rate has resulted in over 20 lawsuits against the Agency challenging its failure to meet
its ESA obligations. The lawsuits have compelled EPA to meet these obligations by assessing the
effects of pesticide actions on listed species and, in most cases, consulting with one or both of
the federal wildlife agencies on those effects. Indeed, nearly every consultation on pesticides
is in response to lawsuits, which now largely set EPA's pesticide consultation workload and
schedule. To date, most of these consultations have covered commonly used pesticides that
affect many listed species. The consultations are typically very complex, lengthy, and resource-
intensive for all involved, with many spanning no fewer than 4 years and some extending to 15
years. EPA's pesticide program has already agreed, through court-enforceable settlements, to
completing 18 ESA assessments within the next six years, which is the most assessments it can
accommodate based on its current process and staffing, while also meeting its other near-term
ESA obligations. EPA is also in settlement discussions that could result in similar agreements for
dozens of additional pesticides. Yet all of these assessments reflect less than 5% of the total ESA
assessments that EPA would need to complete as part of past, current, and future FIFRA actions.
If EPA does not complete this work, it will continue to face legal challenges to its pesticide actions.
This creates uncertainty for farmers and other pesticide users, who could lose access to pesticides
if a court vacates a FIFRA action.
EPA must focus on how to achieve the goals of ESA and FIFRA differently than in the past—to break
the decades-old cycle where ESA goals were not met, and the resulting litigation became the
main driver and priority setter of how EPA fulfills its ESA obligations. The old approach has been
expensive for EPA, expensive for the parties to the lawsuits, and frustrating for all stakeholders—all
while listed species remain inadequately protected. These reasons are why EPA's Pesticide Program
is at a critical juncture, and why the Agency has issued this workplan.
In 2021, prompted by the escalating challenges of fulfilling its ESA obligations for pesticide
decisions, EPA began developing a comprehensive, long-term approach to meeting those
obligations. This effort was not the Agency's first attempt to address this complex issue. Over the
decades, EPA has pursued various approaches to this issue and has stated several times that
it would develop a plan to meet its ESA obligations. Although EPA has made some progress on
improving its ESA-FIFRA program, much more work remains.
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Informed by EPA's past efforts and by its recent discussions with stakeholders and lawmakers, EPA
in 2021 began holding a series of internal and external meetings on how the Agency could fully
address its ESA obligations. These include quarterly ESA-FIFRA meetings with stakeholders and a
widely attended January 2022 public listening session on improving the ESA-FIFRA process.1 The
outcome of all those dialogues is this workplan, which reflects EPA's experiences, assesses its
future ESA workload, and describes administrative and other improvements that EPA will pursue or
consider pursuing. The workplan thus reflects the Agency's most comprehensive thinking to date on
how to create a sustainable ESA-FIFRA program.
The Magnitude of EPA's Pesticide Program
Safe pesticide use offers important contributions to society, particularly in the production of
U.S. food and fiber and the protection of public health from insect and rodent pests. Generally,
there are more than 17,000 registered pesticide products containing more than 1,200 active
ingredients, with uses including insect repellents, household cleaners, lawn and garden
chemicals, hospital disinfectants, biotech products, and a wide range of agricultural chemicals.
In arriving at policy decisions that are informed by sound science, EPA seeks to balance the
interests of many stakeholders. These include more than 88 million households; more than two
million farms; 23,000 commercial pest control firms; a dozen major pesticide producers; another
100 small producers; 1,700 pesticide formulators; 25,000 distributors; several industry, grower,
farmworker, and environmental associations and non-government organizations; and state, local,
and tribal entities.
Although this workplan focuses on ESA and FIFRA obligations, EPA also has obligations under the
Federal Food Drug and Cosmetic Act (FFDCA). Further, several amendments to FIFRA, through
successive versions of the Pesticide Registration Improvement Act (PRIA), set timeframes for EPA
to complete pesticide actions. EPA must meet these obligations alongside those of the ESA.
The workplan is structured as follows. The next section, A Vision of Success, describes EPA's
long-term vision for its ESA-FIFRA work. This vision statement acts as the Agency's north star to
navigate the complexities of this issue, and informs the strategies and actions described later in
this document. The following section, Background and Challenges to Vision, provides a detailed
discussion on the background of key ESA-FIFRA issues and the major challenges to achieving
this vision. EPA provides this extended explanation so the public can understand why meeting
ESA obligations in full is difficult and how stakeholders can help EPA solve those challenges more
effectively. The following section, Strategies and Actions to Advance Vision, is the core of the
workplan, describing the strategies and actions that EPA has developed to advance its vision.
This section also describes how EPA will prioritize certain types of FIFRA actions over others for
ESA determinations, given that the Agency cannot immediately meet its ESA obligations for all
backlogged and future FIFRA actions that trigger ESA obligations. The workplan concludes by
discussing opportunities for the public to engage with EPA on implementing the approaches
described in the document.
1 Visit EPA's Interagency Working Group: Public Meeting on Endangered Species Pesticide Issues webpage.
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Primer on ESA Concepts and Process
Under FIFRA, EPA decides whether to register pesticide products containing new active
ingredients and new uses of currently registered pesticides, and reevaluates all existing registered
pesticides every 15 years as part of registration review. Those are the major actions that may
trigger an ESA assessment for potential effects on ESA listed species and their designated critical
habitats.
An ESA assessment begins with EPA determining whether a FIFRA action may have any effect
on a species or critical habitat. If EPA finds "no effect," no further ESA analysis is needed. If EPA
finds "may affect," the agency further assesses whether the pesticide's use is either "not likely
to adversely affect" (NLAA) or "likely to adversely affect" (LAA) the species or designated critical
habitat. In general, likely harm to even one individual of a species triggers an LAA. EPA describes
its findings in a biological evaluation that it provides to the U.S. Fish and Wildlife Service (FWS),
the National Marine Fisheries Service (NMFS), or both agencies (the Services). For brevity, this
workplan refers to all these findings as "ESA determinations."
FWS (Department of the Interior) and NMFS (Department of Commerce) are charged with
administering the ESA. FWS is responsible for most listed species, while NMFS is responsible for
listed marine species and anadromous fish. Most nationwide pesticide consultations involve both
Services.
For an NLAA finding, EPA seeks the concurrence of the Services in that finding. If the Services
concur, no further ESA process is needed. For an LAA finding, EPA formally consults with the
Services. During formal consultation, the Services determine whether the EPA action is likely to
jeopardize any listed species or destroy or adversely modify any critical habitat—both of which the
ESA prohibits. Unlike the LAA/NLAA findings, the jeopardy/adverse modification findings assess
effects on the entire species, including its ability to recover under the ESA. If the Services propose
jeopardy/adverse modification, they work with EPA and the registrant to negotiate mitigation
measures to avoid these findings. If the measures are adequate, the Services conclude no
jeopardy/adverse modification. If the measures are inadequate, the Services conclude jeopardy/
adverse modification and recommend mitigation that, if adopted, will avoid these prohibitions.
Those measures are called reasonable and prudent alternatives (RPAs) and are in addition to
label restrictions adopted under FIFRA or in a biological evaluation. Even for animal species not at
risk of jeopardy/adverse modification, the ESA requires the Services to develop mitigation—called
reasonable and prudent measures (RPMs)—to minimize the effects of any incidental take on
the species. Incidental take includes unintended injury to or death of an individual of any listed
animal species. In practice, the potential for take of an individual animal triggers an LAA finding.
At the end of formal consultation, each of the Services issues a biological opinion that describes
its findings and mitigation recommendations. The biological opinion also includes an incidental
take statement that exempts the pesticide action from the ESA's take prohibition, if the terms
and conditions of the statement are followed. If EPA implements the biological opinion through
changes to a pesticide registration or label, any person who follows those requirements faces no
ESA liability when applying the pesticide.
To implement the mitigations resulting from formal consultation, EPA may require changes to a
pesticide's registration, label, or use instructions. When those changes are needed only in specific
regions rather than nationwide, EPA may implement the changes through geographically specific
Endangered Species Protection Bulletins. Bulletins Live! Two is EPA's current online endangered
species bulletins system.
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Under registration review, EPA reviews each registered pesticide at least every 15 years to ensure
that each pesticide can carry out its intended function(s) without creating unreasonable adverse
effects to human health and the environment. Each pesticide review is unique but all undergo the
same basic registration review process.
EPA initiates a registration review by establishing a public docket for a pesticide registration review
case and opens the docket for public comment. The docket contains a Preliminary Work Plan
(PWP) summarizing information EPA has on the pesticide and the anticipated path forward. The
PWP includes facts about the pesticide and its current use and usage, anticipated risk assessment
and data needs, and an overall estimate of the time needed for the reviews. Once comments are
received during the 60-day comment period for the PWP, the information received will be used
to update the Final Work Plan (FWP), which is also included in the docket. If data are needed to
update the risk assessments, EPA will issue a Data-Call In (DCI) notice to the registrant under
FIFRA section 3(c)(2)(B).
Once all the required data are received, the Agency will review and incorporate all information into
Draft Risk Assessments (DRA), which always strive to include the best available science. The DRAs
are placed in the public docket for a 60-day comment period.
If ecological or human health risks are identified in the DRA, then the Proposed Interim Decision
(PID) will present the Agency's proposed findings on the FIFRA standard, including the results
of formal ESA consultation, if needed, and the bases for these proposed findings; proposed
modifications to the use of the pesticide to address risks of concern; state whether additional data
are needed; specify any proposed labeling changes; and identify deadlines for completing any
required actions. The PID is published in the public docket for a 60-day comment period.
After considering comments on the PID, EPA will issue an Interim Decision (ID), including an
explanation of any changes from the PID and response to significant comments received on the
PID. The Agency then publishes a Federal Register notice announcing the availability of the ID.
The ID may require new or impose interim risk mitigation measures; identify data or information
needed to complete the review (DCI); and require within 60-days of the ID publication the
submission of updated pesticide labels.
EPA will issue a Final Decision (FD) after it completes a listed species assessment and any
necessary ESA section 7 consultation with the Services. The decision will also account for the
Endocrine Disruptor Screening Program.
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At the outset of the workplan, readers should note two limitations in the document's ability to
provide a complete, detailed path for EPA to fully meet its ESA obligations. First, the workplan does
not provide a schedule for completing ESA determinations for all the pesticides in registration
review. One reason is that EPA has already agreed to completing 18 ESA determinations over
the next six years as part of litigation-driven agreements, which is the most the Agency can
accommodate based on current processes and staffing (see Appendix A for current schedule
and Background and Challenges to Vision section for more information). A schedule for ESA
determinations for registration review beyond that timeframe is unlikely to reflect the most efficient
approach for completing those assessments, given the major process improvements EPA expects to
implement during this time. EPA hopes that these improvements will allow the Agency to complete
more ESA determinations in the future. Further, EPA is currently addressing approximately 18
additional ESA lawsuits on FIFRA actions covering over 1,700 pesticide products, with some of
those lawsuits likely to result in EPA agreeing to complete additional ESA determinations, under
court-enforceable deadlines, that extend beyond the next six years.
A second reason for the lack of a schedule is that at the current pace at which EPA and the Services
are completing pesticide consultations, this process would span decades for all pesticides that have
their first cycle of FIFRA registration review ending in October 2022. To address this challenge, the
Agency needs to prioritize certain FIFRA actions over others as part of fulfilling its ESA obligations
and to work with the Services to develop and adopt program improvements that drastically reduce
the complexity and duration of pesticide consultations. Because EPA does not yet know how
much those improvements will expedite the ESA-FIFRA process, it sees limited value at this time
to developing an ESA schedule that is likely to change considerably in several years. EPA plans to
begin adopting the near-term improvements in this workplan and assess how much those actions
improve the ESA-FIFRA process. That experience will give EPA a far better foundation for developing
an overall schedule within the next three years for conducting ESA determinations for registration
review decisions.
A second limitation of this workplan is that although some strategies and actions are well
developed, others are only in their initial stages of discussion. Thus, this document may read more
like a "plan to develop a plan" for certain actions. This is the inevitable outcome of a document
that covers near-, medium-, and long-term actions, with the latter two influenced by factors
largely outside of EPA's control such as its funding levels in annual appropriations and litigation.
Even though those actions are described with less specificity, they remain crucial for readers to
understand EPA's path to achieving its vision. Based on EPA's implementation of the workplan,
other administrative improvement actions will become evident over the coming years. Thus, readers
should consider this workplan as a living document that will evolve based on lessons learned
through implementation. Within the next two years, EPA will reevaluate its progress under the
workplan and decide whether and how to update it. EPA's hope is that within two years, the process
improvements described in this workplan will allow the Agency to begin increasing the number of
ESA assessments it can complete annually.
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A VISION OF SUCCESS
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A VISION OF SUCCESS
Before beginning this significant and challenging process, EPA developed a vision of success. EPA
has adopted the following vision to guide this workplan and the Agency's ESA-FIFRA work generally.
EPA's Office of Pesticide Programs is protecting federally listed threatened and
endangered species and their designated critical habitats from pesticide effects to an
extent that fulfills our obligations under all federal pesticide use and species protection
laws. Our program is achieving this goal while minimizing impacts to pesticide users,
supporting the development of safer technologies to control important public health and
agronomic pests, and completing timely pesticide registration decisions. Our program
is also working with stakeholders and our federal partners so that we are trusted
experts in protecting endangered species through pesticide registration and registration
review decisions. In making these decisions, we are performing credible analyses that
answer the scientific questions needed to protect species using real-world, up-to-date
information.
EPA developed this vision mindful of the goals of stakeholders and other federal agencies. EPA
thus hopes that all its partners and stakeholders see aspects of the vision that resonates with their
goals. After all, meaningful, enduring improvements to the ESA-FIFRA process cannot occur without
broad consensus about what the process is striving to achieve.
EPA wrote this workplan on its own because the ESA imposes duties on all federal agencies,
including EPA, to meet its legal obligations. The workplan describes how EPA will achieve this with
the help of other federal agencies and stakeholders.
Several specific parts of the vision deserve further explanation. First, as evident from the first line of
the vision, EPA will meet its ESA obligations. This objective, however, cannot exist in a vacuum. EPA
also strives to minimize the regulatory impacts of protections because doing so promotes its other
legal and public policy goals of providing pesticides for agriculture, public health protections, and
natural resource management. Further, EPA has FIFRA deadlines for pesticide actions that it strives
to meet independent of ESA obligations. Those deadlines provide certainty to growers and other
pesticide users about the availability of pesticides.
Second, EPA cannot address the ESA-FIFRA challenge on its own. Even though EPA developed this
workplan independently to help meet its ESA duties, it seeks the help of stakeholders, the Services,
USDA, and lawmakers to implement the workplan. Further, the workplan explains the many
ways that EPA needs to change how it approaches its ESA obligations for FIFRA decisions. EPA,
however, will also need to work with other organizations to change how they approach these issues.
For example, in the short term, as EPA strives to build a workable process, EPA will encourage
stakeholders to allow EPA to focus more of its time and resources to implement conservation
measures needed to meet its ESA obligations, and less on certain data, methodology, or modeling
issues that have limited bearing on the outcome of ESA consultations. EPA will also work with
stakeholders to support greater flexibility for EPA to test new policies tailored to the complexities of
pesticide consultations. EPA will continue to work with stakeholders to give EPA the ability to meet
its ESA obligations at a pace that is realistic given the existing workload and EPA's commitment
to follow this workplan. In short, EPA needs all organizations and stakeholders to work toward a
common goal, such as the one in EPA's vision of success.
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Finally, EPA seeks to work closely with its partners and earn their trust in viewing the Agency as an
expert in ensuring that FIFRA decisions are adequately protecting listed species. EPA realizes that it
has much work to do before it reaches this goal. The Agency is working hard to develop the expertise
and capacity to protect listed species by implementing flexible mitigations that reflect real-world
pesticide usage, exposure, and effects.
One Workplan, Multiple Audiences
Given the long and complicated history of pesticide consultations, EPA expects a range of
interest in this workplan. EPA has written the workplan for many audiences, recognizing that no
single document can convey the ideal amount and level of information to any single audience.
Below is information to help the primary audiences understand how they can use this workplan.
¦ For all audiences, the workplan describes EPA's plans to significantly improve its process to
meet its ESA obligations as part of FIFRA decisions.
¦ For the Services and USDA, the workplan describes opportunities for interagency coordination
on ESA-FIFRA improvements, including actions that require the input and leadership of all four
agencies.
¦ For Congress, the workplan describes EPA's progress under the 2018 Farm Bill, Section
10115 (FIFRA Interagency Working Group) and informs general oversight of the Agency's ESA
and FIFRA work.
¦ For pesticide registrants and users, the workplan describes EPA actions to improve
predictability about the ESA-FIFRA process and opportunities to work with EPA on those
improvements.
¦ For environmental organizations, the workplan describes EPA actions to adopt protections for
listed species, better meet its ESA obligations, and provide opportunities to work with EPA on
those improvements.
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W BACKGROUND AND
CHALLENGES TO VISION
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BACKGROUND AND CHALLENGES TO VISION
To meaningfully improve the ESA-FIFRA process, EPA first needs to articulate for the public its
understanding of the current process and the main challenges to developing a more effective one.
Given the unusual complexity of this issue, it is understandable that some aspects of the process
and challenges are not well understood outside of EPA, making it difficult to appreciate the barriers
the Agency faces to meeting its ESA obligations. The goal of this section is to fill that knowledge
gap and help the public and other agencies to engage with EPA more constructively on ESA-
FIFRA issues. As a result, this section is lengthy and detailed. Readers who are more interested in
understanding EPA's plans to improve the ESA-FIFRA process may want to skim or skip this section.
At the same time, this section does not describe every challenge, only those that EPA views as the
most significant in the coming years to EPA meeting its ESA obligations.
Overview of Different Types of Pesticides
Throughout this workplan, EPA will reference the three types of pesticides it regulates.
Conventional pesticides are all active ingredients other than biological pesticides and
antimicrobial pesticides. Conventional active ingredients are generally produced synthetically
{i.e., synthetic chemicals that prevent, mitigate, destroy, or repel a pest or that act as a plant
growth regulator, desiccant, defoliant, or nitrogen stabilizer).
Antimicrobial pesticides are intended to disinfect, sanitize, reduce, or mitigate growth or
development of microbiological organisms or protect inanimate objects, industrial processes
or systems, surfaces, water, or other chemical substances from contamination, fouling, or
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
Biopesticides are certain types of pesticides derived from such natural materials as animals,
plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal
applications and are considered biopesticides. Biopesticides fall into three major classifications:
Biochemical, Microbial, and Plant-Incorporated Protectants (PIPs).
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Large and growing workload
Most EPA actions under FIFRA require an ESA determination and possibly formal consultation.
These decisions fall into three broad categories: (1) registration of new pesticides, (2) registration
review of existing pesticides, and (3) other FIFRA decisions on existing pesticides, including
registration of new uses of existing pesticides and FIFRA section 18 emergency use exemptions.
To date, EPA has completed ESA determinations and, if necessary, consultations for less than 5% of
these actions, leading to a large backlog of actions that continues to grow (Appendix A).
In addition to this backlog, the Agency will also have many future actions that trigger ESA
obligations. In particular, the registration of new active ingredients, the ongoing 15-year cycle of
registration review for each registered active ingredient, and the approval of new uses and pesticide
label amendments of registered pesticides will amount to tens of thousands of FIFRA actions over
the next decade alone that require an ESA review.
To better describe the level of effort required of EPA to meet its ESA obligations for each category of
FIFRA action, Table 1 shows the estimated required full-time equivalents (FTEs) for actions in each
category. These estimates are based on EPA's current processes, which need optimization to meet
the large and growing ESA workload. The process improvements described in this workplan are
expected to reduce the FTEs for most or all actions, but the extent of the reductions is unknown at
this early stage.
Apart from the growing workload and backlog challenges, the Pesticide Program's staffing levels
have declined from a high of 808 (2005) to 603 (2021). Changes in PRIA IV enabled EPA to
more fully use FIFRA maintenance fees to support the Pesticide Program's activities since 2018,
which helped support more FTEs during this time (see Figure 1). Current decreases in the FIFRA
maintenance fee account may result in EPA being unable to maintain the same FTE level using
funds from this account.
Meeting ESA obligations for registration and registration review decisions alone will require a
multifaceted approach, including capacity, resources, improved processes, updated technology,
workload analysis, and increased stakeholder collaboration. For example, assessing effects on
listed species and their critical habitats involves spatially explicit effects determinations that identify
where a pesticide can be used and where species are likely to be found, and an evaluation of
species' habitats and biological characteristics. Likewise, to implement early ESA mitigation as part
of a FIFRA action, EPA must identify effective and feasible mitigation options, which may depend
on acquiring information about species characteristics and habitats, evaluating that information,
evaluating how pesticides may enter those habitats, and mitigating those effects. The increased
complexity and specificity of ESA determinations, and the increased variety of mitigation options,
require additional communication with the regulated community and other stakeholders. Further,
even if EPA were to incorporate early species mitigation as part of a FIFRA action, it is likely that
consultation with the Services would still be needed in many cases.
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Table 1. Level of effort required of EPA to complete both FIFRA and ESA obligations for each category
of FIFRA action, based on current EPA processes.
EPA's Required Effort Per FIFRA Action, including
Meeting ESA Obligations
FIFRA Action
FTEs for Action
New Active Ingredients Registration
Conventional Pesticides
5.5
Antimicrobials
5.5
Biopesticides
1.0
Registration Review
Conventional Pesticides
8.5
Antimicrobials
8.5
Biopesticides
1.0
New Uses for Existing Pesticides
Conventional Pesticides
2.5
Antimicrobials
3.0
Biopesticides
0.5
Other Expansions of Existing Use Patterns
Conventional Pesticides
1.5
Biopesticides
0.5
Geographically Limited Registrations
Section 18 emergency
exemptions (conventional
pesticides)
0.5
Experimental Use Permits
1.0
Commitments Prioritized Due to Litigation
Conventional pesticides
34 (OPP alone)
ESA Pilots and Method/Process Development
Conventional Pesticides
6.0
Antimicrobials
18
This table estimates the required effort (FTE) for EPA to
complete ESA assessments for all FIFRA actions requiring those
assessments. The estimated effort is based on EPA's current
ESA-FIFRA process and methods, and accounts for preparing risk
assessments, identifying appropriate mitigations, implementing
risk management decisions, and consulting with the Services
when appropriate. Based on the actions in this workplan, EPA
expects efficiency gains to its process over time but is currently
unable to quantify those gains.
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These risk assessment, risk management, and consultation processes substantially increase the time
and effort for making pesticide registration decisions. The following are the main types of FIFRA actions
for which EPA expects to increase its ESA workload in the coming years, based on the Agency's goal of
meeting its ESA obligations.
Historically for some actions in registration review, the Pesticide Program has completed ESA
determinations as part of litigation settlements. OPP must continue to meet its court-enforceable
deadlines across various settlement agreements under registration review (Appendix A). Conducting
these biological evaluations currently requires 3 to 4 FTEs for each evaluation, compared with about half
that level of effort for non-ESA registration review ecological risk assessments. The Agency has agreed
to court-enforceable deadlines to complete draft or final biological evaluations for 18 registration review
pesticides over the next six years. In addition, EPA has agreed to or is in discussions that could result
in completing biological evaluations on dozens of additional pesticide registration or registration review
actions under court-enforceable deadlines that would extend beyond six years.
In January 2022, EPA announced that it will incorporate ESA determinations and protections into its
registration process for new conventional active ingredients. The ESA component is expected to more
than double EPA's workload for these actions, including to conduct the ecological assessment and
mitigate for effects to species. EPA conducts approximately 10 new conventional active ingredient risk
assessments per year and may have 15 or more applications for conventional registrations that are in
different stages within the regulatory process. New active ingredients, however, represent a very small
fraction of the total number of registration actions. Each year, EPA receives hundreds of applications for
new uses for existing conventional pesticides, other amendments, and emergency exemptions.
Similarly, under registration review, EPA comprehensively reevaluates hundreds of conventional
pesticide active ingredients on a 15-year cycle. Incorporating ESA assessment and risk management
into registration review, as described above for new active ingredients, similarly requires more effort and
resources. When EPA reevaluates a pesticide through registration review, it considers all registered uses
of the pesticide. Thus, the reevaluation and accompanying ESA determinations are often complicated by
the regulatory history of the pesticide and the availability of additional information on the pesticide.
EPA is currently unable to incorporate ESA assessment and risk management across all the types of
pesticide registration and registration review decisions, while also complying with statutory deadlines
for FIFRA actions. Although some FIFRA actions will not require formal consultation or extensive
ESA analyses, most others likely will. This challenge is heightened by EPA's recent commitment to
incorporate ESA determinations into its new conventional active ingredient decisions and by its need to
address other regulatory and statutory deadlines.
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PESTICIDE PROGRAM FTEs AND COMPLETED PRIA ACTIONS:
FY2004-FY2021
Pesticide Program FTEs and Completed PRIA Actions:
FY2004-FY2021
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Figure 1. The graph above shows the Pesticide Program's total FTEs and the number of completed
PRIA actions from 2004 to 2021. Increasing FTEs since 2018 reflect changes in PRIA IV that has
enabled EPA to more fully use FIFRA fees to support 0PP activities.
24
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These estimates are based on EPA's current approaches to meeting its ESA obligations, including the
2020 Revised Method for ESA determinations for registration review.1 Although EPA developed the
approaches to increase efficiencies, some aspects of the approaches remain resource intensive and
must be made more efficient. Further, ESA assessments require a high level of specialized education,
training, expertise, and judgment that comes from years of experience. Thus, EPA cannot simply assign
unexperienced staff to cover the resource gap. EPA would need to hire scientists with specialized
education and train and mentor them for several years before they could independently conduct
ecological risk and ESA pesticide assessments.
EPA's capacity to fully meet its ESA obligations at this time is limited and continues to place listed
species at risk and the Agency at considerable risk of ESA lawsuits. Further, because the Agency's
ESA workload is already at capacity for conducting ESA determinations for conventional pesticides
in registration review for at least the next six years, any future court decision or legal settlement to
complete an ESA determination during that time will stretch the Agency's already very thin program
capacity and may undermine EPA's ability to meet its other ESA commitments. EPA is striving to increase
the number of ESA determinations it can complete annually, partly through process improvements
described in this workplan and the FY2023 President's proposed budget that includes an additional
$4.9 million and 10 FTE to integrate ESA requirements in conducting risk assessments and making
risk management decisions.2 How these improvements would translate to increased number of ESA
determinations is unclear at this early stage.
A final challenge related to workload is that EPA's ability to fully meet its ESA obligations also depends
on the ability of the Services to provide timely review of EPA's "not likely to adversely affect" findings and,
where necessary, complete formal consultation and issue final biological opinions. Because FWS is the
lead agency for most listed species, EPA will work with the agency's national consultation program to
ensure our joint priorities are aligned, which is especially important to a workable pesticide consultation
process.
Lack of process for identifying and requiring practical and timely mitigation
The most important conservation outcome of pesticide consultations is to mitigate adverse pesticide
effects to ESA species and critical habitat. The current consultation process, however, does not always
produce mitigation that is both practical for pesticide users to implement and timely to protect species.
There are several aspects of this challenge, some related to developing mitigation and others related to
implementing mitigation.
1 EPA. Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (March 2020).
2 EPA. FY 2023 Budget In Brief (March 2022).
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First is the geographic scope of ESA mitigation. In a variety of situations, mitigation should be location-
specific and tailored to the needs of a specific population, ecosystem, and pest control practice. For
example, if a narrow-range endemic beetle may be exposed to pesticides from only two sources, ideal
mitigation for the species should address those sources without regulating other pesticide users. This
outcome, however, requires local knowledge about the sources and the species. National-level pesticide
consultations lack a consistent process of coordinating with local species experts and pesticide users
to identify mitigation options tailored to local conditions. This type of coordination would require
considerable time and resources. Under EPA's system of developing mitigation, some landowners and
pesticide users have regarded those requirements as overly broad or inapplicable to their situation.
This is partly because they may not recognize that national-level consultations must rely on more
precautionary mitigation measures when geographically refined data are unavailable or prohibitively
difficult to obtain. Conversely, other mitigation requirements may sometimes not be refined enough to
address all effects to a species. For example, a uniform 100' spray buffer might not address exposure
in situations where individuals of a species periodically wander beyond the buffer zone. EPA has no
way of knowing the precise location of suitable habitat for all species, so mitigation measures may not
always cover all suitable habitat or areas where individuals of a species occur, especially for migratory
species. To address this uncertainty, EPA will need to work with the Services and others on monitoring
of mitigation measures and updating future mitigation techniques to reflect the results {i.e., adaptive
management).
A second aspect of the challenge is timing. Historically, ESA-specific mitigation for pesticide
consultations has often been developed as part of formal consultation (often with each of the Services
separately, under different timelines), after EPA spends considerable time and resources developing a
biological evaluation. Because that mitigation occurs years later in the ESA process and typically after
FIFRA registration review label mitigations, the opportunity to streamline assessments and consultations
based on early mitigation is lost. EPA does not currently have a specific process for identifying early ESA
mitigation across all its FIFRA decisions, especially an established process that allows registrants to
propose early mitigation.
Third, the current process for developing biological evaluations focuses on effects to individual
organisms, whereas EPA's ultimate obligation is to avoid jeopardy and adverse modification based on
species-level effects on survival and recovery and to minimize the effects of incidental take. Following
longstanding ESA regulations, EPA has historically focused on individual-level effects in determining
whether a pesticide "may affect" and is "likely to adversely affect" individuals of a listed species
or critical habitat. This determination, however, generally does not consider mitigation to protect
survival and recovery for the entire species, which occurs only during formal consultation to evaluate
jeopardy and adverse modification. But when mitigation is identified during formal consultation {e.g.,
NMFS salmonid biological opinions), considerable work has already gone into developing a biological
evaluation, creating a lost opportunity to identify and adopt the mitigation earlier. Recently, however, EPA
has begun to address this issue by also assessing the likelihood that the effects may rise to the level of
jeopardy for the species or adverse modification for their critical habitat, and implementing mitigation
designed to prevent such effects {e.g., January 2022 registration of the herbicide Enlist). The Agency
expects to expand this approach to other pesticides, as discussed in the next section.
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Fourth, during registration review, the process of implementing mitigations in a final biological opinion is
time consuming and cumbersome. One reason is that EPA's current process of reviewing and approving
amended labels in the registration review program requires manual updates, which is resource intensive
and time consuming for long or complex labels. Although shifting to electronic labeling would address
most of the problem, the Agency has not yet adopted this approach.
Fifth, in situations where EPA cannot identify mitigation that adequately avoids and minimizes effects to
listed species, the Agency currently lacks a specific approach to incorporate compensatory mitigation,
also known as offsets, into nationwide pesticide consultations. FWS defines offsets as measures
to "compensate for remaining unavoidable impacts after all appropriate and practicable avoidance
and minimization measures have been applied, by replacing or providing substitute resources or
environments...through the restoration, establishment, enhancement, or preservation of resources...."1
Habitat restoration and preservation are among the most common types of offsets. Because EPA lacks
a process for incorporating offsets into FIFRA actions, the Agency is unable to take advantage of all
mitigation options to address pesticide effects on species. The Agency also has less flexibility to offer
registrants and growers to mitigate effects, because avoidance and minimization in the form of label
restrictions are the only available tools. The flexibility of including offsets as an option is crucial because
EPA must also consider impacts to growers when the Agency decides whether and how to regulate
pesticides. Even if EPA were to adopt significant label restrictions, unavoidable effects to certain species
are likely to remain for many widely used pesticides. For example, it is difficult to conceive that aerial
spraying of adult mosquitocides could be performed in a manner that avoids exposure to all populations
of listed species in all counties where they occur, partly because the presence and location of many
populations of these species are poorly known, especially for highly mobile species (e.g., butterflies) or
species without well-defined habitats (e.g., habitat generalists). Although monitoring or other approaches
for evaluating the effectiveness of mitigation would resolve some of these uncertainties, unavoidable
effects will still occur in many situations. Another example is the sizable number of pesticides that lack
reasonable options to fully avoid effects to pollinators in indeterminately blooming crops. Some of those
pollinators, however, do have existing conservation programs (e.g., wildflower plantings) that could be
augmented through offsets for the species, thus potentially reducing the likelihood of jeopardy/adverse
modification.
The absence of offsets as an available mitigation option also limits EPA's ability to direct mitigation in
ways that contribute the most to species recovery, especially because many recovery actions qualify
only as offsets. That is, those actions cannot be implemented through site-specific avoidance and
minimization of pesticide exposure. For example, species that require conservation measures to
adapt to climate change may benefit disproportionately from offsets that focus on improving future
habitat needed for recovery, even if the species does not yet occupy the habitat. The same may be
true for species threatened primarily by invasive species or disease, which could be alleviated through
conservation measures that directly address those threats.
4 FWS. Endangered Species Act Compensatory Mitigation Policy (Dec. 2016).
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The sixth barrier to effective mitigation is that the current ESA-FIFRA process does not always result
in comparable mitigation for pesticides with similar risks to the same ESA species. For example, if a
species is affected by five pesticides, one of which comes up for registration review five years earlier
than the other four, the ESA mitigation required for that pesticide would take effect before EPA has
determined mitigation for the other pesticides. Thus, the first pesticide has more ESA restrictions than
the others, until they complete registration review. Even if EPA were able to assess multiple pesticides
within a similar timeframe, the most expeditious process to achieve mitigation is generally through
negotiations with pesticide registrants, which vary across pesticides. In addition, EPA currently lacks
an agreed-upon set of mitigation measures for listed species, which makes standardization of ESA
mitigation across pesticides difficult.
FIFRA actions create unique challenges for ESA consultations
Pesticide consultations are truly unusual in terms of their complexity and geographic scope. In
particular, pesticides are applied by millions of people in response to specific pest problems that may
differ widely across time and place. National-level pesticide consultations—a process that includes
developing biological evaluations and opinions—must address all species effects that are reasonably
certain to occur, as there are no subsequent regional- or site-specific consultations through which EPA
can work with the Services' regional or field offices to address site-specific effects.
Another reason these consultations are challenging is that a pesticide may or may not be used to
the full extent allowed by its label (it is extremely unlikely that a pesticide would be applied at the
maximum rate to all treatable acres simultaneously). Pesticide labels are intentionally flexible to allow
users to apply pesticides at different times and rates best suited to a user's particular pest issue, as
it is impossible for EPA to prescribe specific use conditions for every possible application scenario. In
addition, growers typically only use pesticides when needed because of the costs of using pesticides
(with some exceptions such as pesticide seed treatments) consistent with integrated pest management
principles. Thus, EPA's registration action authorizes a variety of application scenarios involving an
unknown but often large number of pesticide users. This variation and uncertainty make pesticide
consultation fundamentally different from consultations on most other federal projects, which have
a well-defined geographic scope (e.g., a bridge either is or is not built in a specific location). Another
difference is that the indirect effects of pesticides on listed species (e.g., effects on prey or habitat) are
often far more difficult to evaluate than for ESA consultations on infrastructure or construction projects.
Because of these differences, the adverse effects of pesticide actions and the estimation of incidental
take is considerably more difficult than for the average federal action undergoing consultation.
At various times since the 1980s, EPA and the Services have tried to develop workable ESA consultation
approaches for FIFRA decisions, with mixed success. Examples include the 2004 Overview Document,
2013 National Academies of Sciences report on this topic, and the 2015 interagency Interim
Approaches for Nationwide Pesticide Consultations to implement some of the report recommendations.
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EPA then developed its Revised Method for conducting its biological evaluations for registration review
chemicals in 2020, but a complementary document for conducting formal consultation and developing
Services biological opinions does not currently exist. In March 2022, EPA finished consulting with FWS
on its first national-level pesticide biological opinion, based on a biological evaluation that used the 2015
Interim Approaches and supplemented with elements of the 2020 Revised Method. Although NMFS has
completed consultation on over 30 pesticides, three of which were national-level consultations, EPA will
continue discussing with NMFS some of those biological opinions with the intention of implementing the
opinions under EPA's FIFRA authorities and processes. Thus, the three agencies are still improving the
process for formal nationwide pesticide consultation and have not yet developed standalone interagency
guidance for the entire process (i.e., aside from recent biological opinions serving as examples of a
process).
Another challenge associated with the existing consultation process is that most nationwide
consultations involve both Services, with each Service completing its own biological opinion after EPA
consults with each agency. Because FWS has approximately 16 times as many domestic listed species
as NMFS, it is not surprising that FWS will likely take longer to complete a consultation than will NMFS
(although the ranges of NMFS anadromous fish can be considerably larger than those of many FWS
terrestrial species that are habitat specialists). This approach creates several inefficiencies.
First, EPA and the registrants must participate in two separate consultations conducted over different
time periods using different approaches and assumptions, and must implement two different sets of
labels and Bulletins Live Two! changes. Second, this approach generally increases EPA's workload as
the Agency often has to provide updated information for the consultation with each of the Services,
particularly when the consultation spans several years {e.g., update section 7 "action" to reflect agreed
upon mitigations).
Incorporating ESA requirements into the current FIFRA process presents
unique challenges
Similar to how the pesticide consultation process is not adapted to the complexity and volume of FIFRA
decisions, the current FIFRA process poses challenges to pesticide consultation needs.
First, EPA's current chemical-by-chemical approach for addressing ESA creates unequal mitigation
requirements among pesticides and may not result in optimal species protection. Further, this approach
does not scale well to addressing the over 1,000 pesticide ingredients and over 18,000 registrations
that EPA must evaluate every 15 years as part of registration review. Another reason the current
approach is problematic is that growers can often choose among multiple pesticides to address their
pest issues. Thus, listed species may not benefit from mitigation for a particular pesticide if a grower
switches to another comparable pesticide for which EPA has not yet required ESA mitigation.
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Second, as part of final registration review decisions, EPA needs to consider the outcomes of any
biological opinion and implement any mitigation the Agency determines is needed. This process will
likely include working with the registrants to incorporate the measures onto product labels. If the
registrants are not amenable to making these changes, EPA may need to initiate cancellation of uses or
products, which is protracted and resource intensive, involving public comment and interagency review.
Even when a registrant voluntarily agrees to incorporate ESA mitigation on the label, the current FIFRA
process includes spending additional resources to review labels, particularly if the ESA consultation is
not completed until several years after the registration review interim decision and if the labels require
additional revisions because of the consultation and any public comments. All these processes apply
regardless of the number of measures needed to meet ESA obligations.
Finally, the registration review schedule is based on the date of the initial registration of a pesticide or,
if a pesticide has completed registration review, the date of the most recent final registration review
decision. EPA's schedule for conducting ESA analyses, however, has been largely driven by litigation
and court-ordered deadlines. These two schedules are often different, creating misalignments between
when EPA evaluates a pesticide in registration review and when the Agency performs the ESA analyses
on the pesticide. This misalignment is inefficient for EPA, because the Agency is not conducting all of its
analyses for a pesticide at the same time.
Challenges related to data and risk assessment tools
In recent years, EPA and the Services (all of whom have focused their efforts mostly on conventional
pesticides) have seen a welcome shift to using more refined data, models, and other risk assessment
tools for ESA determinations. This includes better information on species ranges, pesticide use and
usage (e.g., typical application rates and number of applications, geographic area treated), and
toxicological effects of pesticides on species. The shift in data and tools to increase efficiency, however,
has also resulted in biological evaluations that are considerably more detailed, complex, and longer.
This trend toward more and better information has generally improved the foundation of both FIFRA and
ESA findings but can result in a very lengthy ESA-FIFRA process. Below, EPA discusses several aspects of
this tradeoff and other challenges related to data for pesticide consultations.
First, better species data would benefit several aspects of pesticide consultations. For example,
spatially refined, subcounty range maps are not available from the Services for all species. Without this
refinement, EPA must assume a species occurs in an entire county or multiple counties, even when
it likely does not. As a result, mitigation measures will apply even in areas where the species may not
occur, creating unnecessary restrictions on pesticide users. In addition, more refined data could also
increase the number of EPA's "no effect" or "not likely to adversely affect" determinations, increase
stakeholder confidence in EPA's effect determinations, and avoid formal consultation on species or
habitat that are unlikely to experience pesticide exposure.
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Beyond range species data, pesticide consultations would also benefit from better information on
individual species biological responses to pesticides and effective mitigation techniques, especially
for species facing the greatest risks from pesticides (those species are still being identified). For
instance, information on the effectiveness of offset measures would inform how much EPA must rely
on avoidance and minimization.
Despite the value of better data, incorporating the data into biological evaluations can be very
resource intensive for EPA and thus extend consultations by several months or longer. For example,
incorporating county-specific information for a wide ranging species (e.g., found in many states, such
as the Indiana bat) can be much more difficult than for a species with a small range (e.g., may only
be found in several counties, such as the Barton Springs salamander). Another example comes from
EPA's ESA methods, which have led to increasingly refined analyses to guide its "may affect" and
"likely to adversely affect" findings for currently registered pesticides in registration review where
usage data are available.1 Although this trend has generally increased the scientific rigor of the
findings, EPA's experience applying the Revised Method is that the process is very resource-intensive
when addressing the over 1,600 U.S. listed species and over 800 critical habitat designations. This
level of work—which requires adequate staff, subject-matter expertise, and computer resources and
which typically spans two years—far exceeds what EPA can handle across the hundreds of pesticides
for which it must issue ESA determinations in the coming years. Moving forward, EPA must better
distinguish between refined data and methods that generate a good return on investment for the
Agency, and those that do not. Stakeholders can help with this tradeoff by focusing their interactions
with EPA on the types of data and analyses that are likely to improve ESA effects determination or
mitigation. To support this approach, EPA will need to clarify the types of data useful for refinements
and the timing to submit the data, as sometimes data submitted in response to a draft biological
evaluation are not used in a meaningful way.
EPA is mindful of the limits to which more or better toxicological effects data will increase the number
of "no effect" findings or add value to the consultation process. By their nature, pesticides are
designed to affect organisms. At the same time, the "may affect" threshold is inherently sensitive,
currently defined as covering situations "when a proposed action may pose any effects on listed
species or designated critical habitat."2 Particularly for wide ranging species or species that frequently
occur in or near lands or items treated with pesticides, "no effect" findings may be very difficult, if not
impossible, to reach without significant mitigation. Thus, better data need to be augmented with more
efficient regulatory approaches to handling "may affect" and "likely to adversely affect" situations,
especially those accompanied by mitigation that reduces the effects. EPA will thus need to develop
approaches that are consistent with the principles of the Revised Method for conventional registration
review pesticides but far more efficient to apply.
5 EPA. Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (March 2020).
6 See the definition for "may affect" in U.S. Fish and Wildlife Service and National Marine Fisheries Service Endangered Species
Consultation Handbook at page xvi.
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Second, another drawback of EPA's historical approach for conducting ESA analyses (focusing on
effects determinations) is that it does not direct identify or implement ESA mitigation. As such, EPA
has not yet developed a process for registrants to offer mitigation for listed species or critical habitats
as part of the FIFRA process. As explained earlier, the Revised Method focuses on assessing exposure
and effects at the level of individual organisms, rather than on developing mitigation at the level of the
entire species. The former is necessary under the regulations for section 7 consultations, but the latter
is more relevant to the ESA's goal of species recovery and the prohibitions on jeopardy and adverse
modification. Because pesticide consultations are unique and would benefit from early mitigation, EPA
seeks to expand the scope of its ESA assessment to assess and focus on species-level impacts and
associated mitigation needs while minimizing resources needed to make effects determinations at the
level of the individual.
Third, EPA's current processes and infrastructure limit the Agency's ability to expeditiously or
consistently incorporate all updated species or pesticide data it receives from the Services or
stakeholders into its biological evaluations and ESA determinations. For example, the current process
of developing a biological evaluation for a registration review pesticide takes over two years. Refined
data that become available 18 months into the process cannot be incorporated into a draft or final
evaluation, without delaying release of the document and without further increasing the resources
needed to produce a biological evaluation. In almost all situations, EPA has no ability to delay because
it is under a legal deadline to produce a draft or final evaluation. Thus, the Agency has cutoff dates by
which it can no longer incorporate additional data into its ESA analyses. Similarly, biological opinions
can take several years to produce, and the current timeline in which the Services can complete
consultations exacerbates this challenge to updating data. Incorporating additional data during
consultation would similarly require EPA resources that have transitioned to working on the next court-
ordered biological evaluation, to return to the prior assessment and update information that would
not have been needed had the consultation been completed more quickly. EPA's current information
management systems for species maps and other key data, combined with the current consultation
process, impede the Agency's ability to incorporate all updated data into its ESA determinations.
Fourth, data on pesticide usage for currently registered pesticides are important for accurate risk
assessments and meaningful mitigation but must be used in the proper context. Given the strong
public interest in usage data, EPA first needs to explain why it uses usage data in ESA assessments.
EPA registers pesticide products that include labels with use patterns that are intentionally flexible to
allow users to apply pesticides at different intervals and rates depending on a particular pest issue.
Although an individual may apply a pesticide at the maximum labeled use, it is highly unlikely that a
pesticide would be applied at this maximum rate in all areas by all users simultaneously (or even within
a single year).1 Thus, EPA uses pesticide usage data to better understand where and how the pesticide
has been used historically, and to inform where and how it is likely to be used in the future. This
prediction allows EPA to refine its assessments to focus resources and mitigation in areas where uses
are most likely to occur and thus affect ESA species.
7 Some pesticides require exact application rates, but most do not.
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When usage data are unavailable or inadequate—which is especially a challenge for new pesticides
with no usage data, and for biopesticides and antimicrobial pesticides for which these data are rarely
if ever available—EPA typically makes conservative assumptions (e.g., that 100% of treatable use sites
will actually be treated at the maximum label rate). These assumptions overestimate exposure and the
potential for incidental take and could result in EPA imposing unnecessary mitigation. Unnecessary
mitigation can also complicate pesticide labels, thus stretching limited EPA resources. Certain
mitigations can also reduce access to pest management tools or exacerbate pest resistance problems.
Thus, high-quality usage data are key to prioritizing limited EPA resources and supporting better risk
assessment and management decisions for currently registered pesticides. For new pesticides, other
information is necessary to characterize how the pesticide will likely be used.
Despite the importance of usage data for assessing currently registered pesticides, EPA acknowledges
several important limits to the use of these data when they are highly spatially refined (e.g., county
level). Although high resolution data provide more precise information about how a pesticide was used
in a particular location in the past, those data may incorrectly predict future pesticide usage in that
area because the actions of a single user can strongly bias historical usage estimates. By contrast,
geographically coarser usage data in areas experiencing similar pest pressure (e.g., state level) can
offer better insights into the potential for future usage by averaging usage across multiple users, thus
accounting for variability in use (e.g., crop rotations) and usage. For conventional pesticides, EPA uses
state-level usage averages in its ESA assessments because this approach is unlikely to underestimate
future exposure to ESA species.
Further, current usage data for registered pesticides vary considerably in quality. For example,
California's Department of Pesticide Regulation usage data are unmatched in their spatial and temporal
resolution. Usage in California, however, cannot readily extrapolate to other states. Currently, the only
annually collected nationwide data on agricultural pesticide usage come from a pesticide usage survey
conducted by Kynetec USA, Inc., that covers approximately 70 of the largest agricultural use sites. The
data are provided only through a license and cannot be redistributed to or explored by unlicensed groups
in their raw format. As a result, EPA's ability to provide full transparency of usage data is contractually
limited. EPA does, however, provide in its biological evaluations the summarized usage data averaged
by crop over five years. Besides the Kynetec dataset, EPA also uses other nationwide datasets including
USDA National Agricultural Statistics Service (NASS) Chemical Use Program. Although the NASS dataset
is publicly available, it does not survey most agricultural use sites annually. EPA uses this dataset to
inform and validate usage data from Kynetec, but the publicly available NASS data cannot currently
replace the usage data from Kynetec for most crops. EPA generally has high confidence in the usage
data from these various sources. Certain use sites, however, are rarely or never surveyed (e.g., small
acreage crops and non-agricultural use sites), and usage data sources for biopesticide and antimicrobial
active ingredients are generally unavailable.
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State-level usage estimates strike a balance between national-level usage, which can mask regional
or local differences in usage, and substate usage, which can vary in quality because of the potential
low number of individuals used to derive the estimate. State-level estimates can be readily applied in a
manner that adequately protects ESA species (e.g., allocate all projected acres treated in the state onto
the species range).
In certain cases, EPA could benefit from more spatially refined usage data than those generally available
today. One solution may be for pesticide applicators, working with USDA and other organizations, to
provide those substate data. If available, the data could also allow EPA to incorporate species mitigation
at the substate level, which could avoid unnecessary restrictions in areas where a species and its
critical habitat does not occur.
There are additional challenges for conducting ESA assessments for antimicrobial pesticides. For
antimicrobial use patterns that could result in outdoor exposures, the highest environmental exposures
are expected to occur in aquatic habitats. Out of the many potential use sites that could result in aquatic
exposures, EPA currently only has screening level exposure models for a very limited set of uses that
are believed to result in the highest potential exposures (i.e., anti-fouling paints, cooling towers, paper
mills and other industrial settings, down-the-drain uses, wood treatments for docks, and material
preservation for outdoor paints). All the available exposure models are conservative, FIFRA screening-
level models intended to inform whether there is the expected potential for risks from a registered
antimicrobial use. None of the available screening-level models allows EPA to quantify potential effects
to listed species.
Additionally, because of the focus on aquatic exposures, there are generally no existing methods that
allow EPA to conduct an exposure assessment for any terrestrial species. Further, ecotoxicity data for
terrestrial species are often more limited for antimicrobial pesticides than for conventional pesticides
because of differences in data requirements, and EPA receives frequent FIFRA requests to waive these
data. This situation may limit EPA's ability to fully address direct and indirect effects without calling in
additional data for antimicrobial pesticides. Additionally, data that identify the locations of potential use
sites are not currently available for any antimicrobial use patterns. Usage data are generally lacking for
antimicrobial uses and are limited to production volumes per year at the national level, if available at all.
The lack of available spatial data for antimicrobial use patterns limits the ability to conduct an overlap
analysis to identify the species and critical habitats that may need to be assessed. For these reasons,
the risk assessment methods and processes developed for conventional pesticides do not apply to
assessing antimicrobial uses. Further, the ability to complete ESA determinations for antimicrobial
pesticides would require significant model development, data collection, and coordination across
stakeholders and the Services.
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Need to continue improving the working relationship among agencies
A major aspect of an effective consultation process is trust and mutual respect between EPA and the
Services. As many close observers of the ESA-FIFRA process know, there is room for improvement in
this area. Particularly as EPA embarks on major improvements to the ESA-FIFRA process, the Agency
will need strong working relationships with headquarters and regional or field staff in the Services. For
example, identifying and overseeing species mitigation will sometimes require EPA to work with regional
staff that are the lead in conserving a species and that have relationships with landowners. Only through
mutual trust can the interagency relationships lead to more efficient consultations and conservation.
One reason that EPA has written this workplan is to show its federal agency partners and stakeholders
how the Agency intends to work in good faith toward the goals of ESA consultation.
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STRATEGIES AND
ACTIONS TO
ADVANCE VISION
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STRATEGIES AND ACTIONS TO ADVANCE VISION
To achieve EPA's vision, the workplan establishes four overlapping strategies and multiple actions to
implement each strategy. The first strategy is for EPA to meet its ESA obligations for all FIFRA actions
that require ESA determinations and consultations. These actions include those with pending court-
enforceable deadlines to complete ESA assessments, and the considerably larger number of actions
without court-enforceable deadlines. The second strategy is for EPA to improve its approaches to
identifying and requiring ESA mitigation earlier in the FIFRA process. These improvements will include
prioritizing mitigation for species most vulnerable to pesticides, offering pesticide users greater flexibility
in adopting mitigation, and developing internal policy and program changes to support EPA's mitigation
goals. The third strategy is to improve the efficiency and timeliness of the consultation process. Unlike
the first two strategies, this strategy relies heavily on collaboration with the Services and USDA.
Similarly, the fourth strategy of improving EPA's stakeholder engagement is external facing. The Agency
is especially interested in working with stakeholders on data and analyses to support more timely and
efficient ESA determinations and consultations.
For each action, EPA has also identified the timeframe for implementation relative to the date of this
workplan. In general, actions that are expected to be developed farther in the future are described with
less specificity than those in the near term. Many of those details will depend on how EPA implements
the latter and on other factors such as its future litigation, workload, backlogs, and resources.
Throughout this section, EPA has been deliberate in conveying whether it is committing to pursue an
action. For actions that the Agency will definitively pursue, the workplan uses "will" or other affirmative
language. For actions that the Agency cannot yet commit to or is still evaluating, the workplan uses
"may," "could," "will consider," or other equivocating words. The workplan thus contains a mix of
definitive and aspirational actions.
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Divisions of EPA's Pesticide Office
EPA has identified the divisions within its Office of Pesticide Program that will lead each of the
actions described in this section. The main responsibilities of each division are as follows.
Antimicrobials Division (AD). AD is responsible for all registration and registration review activities
for antimicrobial pesticides including the review of scientific data, development of human
health and ecological risk assessments, and regulatory decision making for new registrations,
registration review, and reregistration.
Biological and Economic Analysis Division (BEAD). BEAD evaluates use information for identifying
the action area, usage information for refining the extent of exposure, and the potential impacts of
mitigation on pesticide users in support of biological evaluations and biological opinions through
analyses provided to OPP and the Services, respectively.
Biopesticides and Pollution Prevention Division (BPPD). BPPD is responsible for all registration
and registration review activities for biopesticides (microbials, biochemicals, and emerging
technologies) including the review of scientific data, development of human health and ecological
risk assessments, and regulatory decision making for new registrations and registration review.
Environmental Fate and Effects Division (EFED). EFED is responsible for conducting ecological,
drinking water, and endangered species assessments to evaluate potential risks posed by
conventional pesticides for registration and registration review and effects to listed species. EFED
also houses Bulletins Live! Two.
Health Effects Division (HED). HED is responsible for conducting human health risk assessments
to evaluate potential risks posed by conventional pesticides for registration and registration
review.
Pesticide Re-Evaluation Division (PRD). PRD is responsible for the re-evaluation of currently
registered conventional pesticides and for the development of risk mitigation measures to ensure
that they continue to meet the FIFRA registration standard.
Registration Division (RD). RD is responsible for developing regulatory decisions for conventional
pesticides. This involves risk management and regulatory determinations for all conventional
new chemicals, new uses, new products, and product amendments. RD is the office lead for
emergency exemption requests submitted under section 18 of FIFRA. RD completes product
specific science review for acute toxicity, chemistry, and efficacy for public health products.
RD also develops risk assessments and regulatory decisions for inert ingredients contained in
pesticides.
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STRATEGY 1: MEET ESA OBLIGATIONS FOR FIFRA ACTIONS
The overarching purpose of this workplan is for EPA to meet its ESA obligations for all FIFRA actions
that require ESA review. Given the hundreds of FIFRA actions annually that trigger these obligations,
the Agency cannot simultaneously and immediately meet these obligations for all these actions.
Rather, EPA will increase the number of its ESA determinations and consultations as efficiencies
and resources allow. As part of this phased approach and as outlined in this workplan, the Agency
has identified at this time which types of actions are the highest priorities for addressing ESA
obligations and which are lower priorities.
The top priority is for EPA to meet its existing and future court-enforceable deadlines, most of which
cover existing pesticides in registration review, newly registered active ingredients, and new uses
of existing pesticides. The next priority covers registrations of new conventional active ingredients,
which EPA has committed to assessing through its January 2022 announcement on these actions.
This means that EPA will not register a new conventional pesticide without ensuring that EPA meets
its ESA obligations before granting the registration. EPA has prioritized these actions for several
reasons, including to help ensure the legal defensibility of new chemistries, which are often safer
than existing chemistries, and because EPA can negotiate mitigation more expeditiously for new
registrations than during registration review.
The next tier of priority is for the remaining conventional pesticides in registration review. Given
the hundreds of registration review cases that still require an ESA determination, EPA currently
needs many years to complete these determinations and, if needed, consult with the Services on
each pesticide. The time and resources to complete this work on the part of all three agencies is
the main reason EPA has not assigned a higher priority to these actions. With that said, certain
actions for pesticides in registration review that are not already subject to litigation-related
deadlines are especially urgent and are among EPA's highest priorities for its ESA-FIFRA program
within its portfolio of registration review chemicals. In particular, implementing existing NMFS
biological opinions with jeopardy findings is crucial to minimizing extinction risks. In addition, EPA
is developing early mitigation for a subset of species predicted to be at risk of jeopardy/adverse
modification for several registration review pilot chemicals, as outlined in this workplan, and then
plans to expand these measures to certain other high priority registration review chemicals. EPA's
vulnerable species initiative and the federal interagency mitigation pilot project, both discussed in
the mitigation strategy section below, will also inform the Agency's early ESA mitigation efforts.
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The final tier of priorities consists of all other FIFRA actions for conventional pesticides {e.g., new uses)
and FIFRA actions for non-conventional pesticides. In general, ERA'S work to address its ESA obligations
for this final tier of actions is the least developed. For example, EPA does not have ESA methods specific
to antimicrobials, and ESA methods for biopesticides are not as developed as those for conventional
pesticides. Nonetheless, EPA will develop efficient approaches for these actions and will continue to
determine, on a case-by-case basis, how best to address its ESA obligations for the actions. For example,
certain mitigation actions in this workplan may allow EPA to make ESA determinations and, where
necessary, consult on some new uses. In those cases, EPA may be able to prioritize the determinations/
consultations by conducting them concurrent with consultations for new active ingredient registrations
or for chemicals in registration review. Similarly, through this workplan, EPA expects to adopt systemwide
process efficiencies that will allow the Agency to complete more ESA assessments and consultations
over time. In that scenario, EPA expects to meet its ESA obligations for this final tier of FIFRA actions
sooner.
To help readers better understand the number of FIFRA actions associated with each of the three tiers,
Table 2 shows the approximate number of actions that EPA completes annually that may require an ESA
analysis and, where the information is available, the approximate number of ESA "no effect" findings for
each category of action. As readers can see, the number of actions for new uses, expansion of existing
uses, and geographically limited registrations far exceed the number of actions for new active ingredient
registrations and registration review. As discussed above, this is one reason that EPA has prioritized the
latter for ESA review.
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Table 2. Estimated number of FIFRA actions completed annually that may require ESA review. As
explained throughout this workplan, EPA does not currently complete an ESA review for most of these
actions.
FIFRA Action
No. of
Actions
Comments
New Active Ingredients (Als) Registration
Conventional
Pesticides
10
EPA may have 15 in-house submissions at any time.
Antimicrobials
5
EPA may have 5 antimicrobial in-house submissions at any
time in different stages of registration. EPA estimates that
l/5th of these will have "no effect" on ESA species.
Biopesticides
30
EPA may have 40-50 new Als in-house at any given time in
different stages of registration. While many biopesticides
result in "no effect" (approx. 2/3), some will require additional
ESA work.
Registration Review
Conventional
Pesticides
40
There is a wide range of the number of registration review
risk assessments depending on where EPA stands in its
registration review cycle. EPA averaged approximately 40
conventional pesticide DRAs per year over the past 10 years
and typically ranges from approximately 20 to 60 annually.
Antimicrobials
15
There is a wide range in the number of registration review
risk assessments depending on where EPA stands in its
registration review cycle. AD averaged approximately 15
antimicrobial pesticide DRAs per year over the past several
years. AD expects that approximately 30 percent of DRAs will
be "no effect."
Biopesticides
30
cases
There is a wide range of the number of registration review
risk assessments depending on where EPA stands in its
registration review cycle. BPPD works on about 30 biopesticide
"cases" (some cases have multiple Als) per year over the past
10 years, on average. While many biopesticides result in "no
effect" (approx. 2/3), these calls will need to be reconfirmed,
and other cases will require additional work.
New Uses for Existing Pesticides
Conventional
Pesticides
80
Approximately 60 to 100 new use applications are received
each year that could require ESA analysis. Many additional
new use applications are submitted that may not require new
ecological risk assessments to make a FIFRA determination.
The amount of risk assessment effort for new use registrations
has historically been lower compared to the effort required
for new chemical registrations. For example, ecological risk
assessments may simply refer to existing assessments if
sufficient to inform the FIFRA determination.
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Table 2 (cont.). Estimated number of FIFRA actions completed annually that may require ESA review.
As explained throughout this workplan, EPA does not currently complete an ESA review for most of
these actions.
New Uses for Existing Pesticides
Biopesticides
20
Approximately 20 new use applications are received each
year for BPPD with about l/3rd of them having the potential
to require ESA analysis. Some measure of efficiency would be
expected in future years as more BPPD chemicals undergo
ESA analyses.
Other Expansions of Existing Use Patterns
Conventional
Pesticides
140
Other actions that may increase ecological exposure and,
therefore, require science support may include requests
to change existing product application methods for a
registered use site (e.g., increase application rate, number
of applications, etc.) or applications for products in a new
physical form. The number of applications received each year
varies and may range from approximately 120 to 160.
Biopesticides
50
Other actions that may increase ecological exposure and,
therefore, require science support may include requests
to change existing product application methods for a
registered use site (e.g., increase application rate, number
of applications, etc.) or applications for products in a new
physical form. The number of applications received each year
varies but only about l/3rd would be expected to require ESA
work.
Geographically Limited Registrations
Section 18
emergency
exemptions
(conventional
pesticides)
100
Science support is historically more limited for these types of
actions and focuses on a review of information submitted by
the state applicant. The number of applications received each
year varies and may range from approximately 80 to 120. ESA
analysis for antimicrobial and biopesticides is expected to be
minimal.
Experimental
Use Permits
(EUPs)
5
EUPs for emerging technologies are basically treated as new
Al assessments for BPPD. In recent years, many of these EUPs
already receive some type of an ESA analysis. Some of these
may result in "no effect," but others will require additional
work. ESA analysis for antimicrobial and conventional
pesticides is expected to be minimal.
Commitments Prioritized Due to Litigation
Conventional
pesticides
5
This represents resource commitments from various
litigations. Litigation discussions are ongoing for dozens of
pesticides related to ESA.
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Having described the relative priorities of these different types of FIFRA actions, the section below
summarizes the steps that EPA will or plans to pursue for each type of action.
Meet court-enforceable ESA deadlines
EPA's highest priority for the pesticide program is to meet its court-enforceable ESA deadlines and
other commitments to courts. The deadlines cover dates for issuing draft biological evaluations, final
biological evaluations, and implementing biological opinions for a variety of pesticide active ingredients
and pesticide decisions (see Appendix A). Although EPA's current ESA workload is largely driven by
these settlement deadlines, with this workplan the Agency expects to reduce the number of deadlines
established through litigation and be able to set its own priorities using far more efficient approaches to
meeting its ESA obligations. Fewer litigation-driven deadlines allow EPA more opportunities to complete
the other actions in this workplan and to accommodate ESA assessments for all FIFRA actions that
trigger ESA requirements. This is why in the long term, EPA seeks to set deadlines for its ESA obligations
based on priorities the Agency establishes on its own.
Lead division(s): EFED, PRD, RD
Timing: In progress. As Appendix A shows, EPA has 18 chemicals with court-enforceable deadlines
or other court commitments through 2028, with additional chemicals in current litigation where
litigants are likely to request EPA add more chemicals to this schedule.
Meet ESA obligations for new registrations for conventional pesticide ingredients
As announced in January 2022, EPA will meet its ESA obligations for all new registrations for
conventional pesticide active ingredients.1 To further this objective, EPA will not issue new registrations
for these ingredients without first making ESA assessments (effects determinations and predicting
the likelihood of jeopardy and adverse modification), implementing needed mitigation, and initiating
consultation with the Service(s) if necessary (consultation is unnecessary if EPA makes "no effect"
findings for all covered species and critical habitats). In phasing in the policy, consistent with its ESA
obligations, EPA may need to issue a final registration for a pesticide even if the Agency has initiated but
not completed consultation for the pesticide. The policy allows the Agency to meet its ESA obligations
and to provide regulatory certainty to pesticide registrants and users, and to strive to meet the
applicable PRIA deadlines for new pesticide ingredient registrations.
Where EPA initiates consultation and then registers a new pesticide before completing formal
consultation, the Agency will include a determination that issuing the registration will not violate the
ESA's section 7(d) prohibition on making "any irreversible or irretrievable commitment of resources" that
prevent the Agency from formulating or implementing any reasonable and prudent alternatives identified
through formal consultation. If EPA deems that a new pesticide submission is unable to adequately
mitigate for effects that are likely to trigger a jeopardy or adverse modification finding during formal
consultation, the Agency will notify the applicant that its registration cannot be granted until consultation
can be completed. At that point the applicant could wait for consultation to be completed, withdraw their
application, or request a denial of the registration.
8 EPA. EPA Announces Endangered Species Act Protection Policy for New Pesticides (Jan. 2022).
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The ability to complete consultation before a final registration decision will depend on various factors,
some of which are outside of EPA's control. These include EPA's and the Services' capacity to complete
pesticide consultations, devising a more efficient consultation process, registrant willingness to
change labels prior to EPA approval, and existing court-enforceable deadlines for completing biological
evaluations. Where EPA has initiated consultation and issues a final registration before completing that
consultation, it will have, at a minimum, completed its ESA analysis and made its effects determinations,
required early mitigation for ESA species as part of the registration, and required terms of the
registration that allow EPA to amend the registration to reflect the outcome of consultation. In particular,
for geographically specific mitigation requirements, EPA may implement them through pesticide labels
that refer users to EPA's Bulletins Live! Two or through updating existing bulletins. Where applicable, EPA
will update bulletins shortly after registration to ensure prompt protections for species and to ensure
that pesticide users regard bulletins as a reliable source of information.
In the future, EPA expects that any necessary consultation would be completed before registering a new
conventional pesticide. Exactly when this will begin depends on the factors identified above.
To implement the January 2022 policy, EPA will:
¦ Consult on new conventional registration submissions. As of January 2022, EPA began
implementing this requirement and will continue doing so for new pesticide active ingredient
submissions. EPA is currently phasing in this action, starting with new conventional registration
submissions that it had already received as of January 2022.
Lead division(s): RD, EFED, and BEAD
Timing: Started January 2022
¦ Adopt mitigation for species. EPA plans to predict whether the new Al registration could
jeopardize listed species or adversely modify its critical habitat. If jeopardy or adverse
modification is predicted to occur, EPA will adopt mitigation intended to avoid both. EPA may
also adopt additional mitigation to reduce exposure to listed species even when effects are not
predicted to result in jeopardy/adverse modification.
¦ Adopt flexible mitigation. EPA will identify and offer pesticide users more flexible approaches to
mitigating for effects to listed species (see mitigation strategy below for more information).
¦ Coordinate mitigation between new registrations and registration review. EPA will begin
coordinating mitigation between new registrations of pesticide ingredients and related
registration review conventional pesticides, to help ensure consistent mitigation among
pesticides that cover similar uses (see mitigation strategy below for more information).
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Process for ESA Review for New Conventional Active Ingredient Submissions
Figure 3."J/AM" analysis refers to EPA's prediction of whether a pesticide is likely to cause jeopardy or
adverse modification.
Meet ESA obligations for new registrations for conventional pesticide ingredients
already registered or undergoing registration review
Meeting ESA obligations for registration review will continue to represent the bulk of the Agency's ESA
workload, as there are far more pesticide cases in registration review than new pesticide ingredient
submissions. EPA's current and future ESA workload for registration review consists of (1) pesticides for
which the Agency has committed to court-enforceable deadlines, as described earlier, and (2) pesticides
not covered by any court-enforceable deadlines, which are the focus of this section.
Under court settlements, EPA has already been consulting on several conventional pesticide registration
review pesticides, creating a foundation for the Agency to increase the number and speed of consultations
it can complete as part of future registration review decisions for pesticides not covered by a court-
enforceable deadline. Although EPA and the Services are improving the consultation process, far more
efficiencies are still needed as the current situation creates an unsustainable workload for EPA and the
Services and does not result in timely mitigation. The lack of greater efficiencies has resulted in EPA
completing biological evaluations for only a small fraction of the pesticides in registration review. Moving
forward, EPA, working with the Services, will strive to fulfill its ESA obligations far more efficiently, with
priority on early mitigation for vulnerable species {i.e., species at greatest risk of pesticide exposure, as
defined later in the mitigation strategy).
The Agency will do so through a multistep process that includes working with the Services to develop
general guidance on using offsets for pesticide consultations including ecosystem-scale and advance
mitigation opportunities, working with registrants to identify and adopt offsets for specific pesticides
and species, ensuring that adopted offsets are legally binding as a condition of a FIFRA registration, and
working with the Services to oversee implementation of offsets.
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To implement EPA's obligations for registered pesticides, the Agency will:
¦ Implement the terms of existing pesticide biological opinions. Besides the biological opinions
for which EPA has court-enforceable deadlines to implement, EPA has other NMFS biological
opinions that it is implementing with NMFS. See Appendix A.
Lead division(s): PRD, EFED
Timing: In process
¦ For select conventional pesticides, mitigate for certain species. Given EPA's large ESA workload
for registration review, the Agency needs to identify a set of pesticides and species as a starting
point to focus its early ESA mitigation measures, before the start of formal consultation. To
further this objective, EPA has identified the following pesticides with court-enforceable deadlines
(some of which have been fulfilled) as pilots to incorporate early mitigation under registration
review: methomyl, carbaryl, certain neonicotinoids, and rodenticides. Each of these pesticides or
pesticide classes are at different stages in the FIFRA process (e.g., risk assessments conducted,
proposed interim decision, interim decision) and in the ESA process (e.g., biological evaluation
not yet conducted, biological evaluation in process, formal consultation initiated). This variety will
allow EPA to determine how best to incorporate early mitigation at each of those stages. Each of
the pilot chemicals will focus on a subset of species that EPA determines has a high likelihood
of jeopardy or adverse modification for that chemical. EPA plans to incorporate early mitigation
to address likely effects to those selected species as part of the FIFRA process or through EPA's
biological evaluations (more details in the mitigation strategy section).
For these registration review pilots, EPA plans to provide information on the species and
associated mitigations in the preliminary interim decision (PID) or an amended PID. In addition to
providing a formal opportunity for our stakeholders to provide feedback, EPA hopes this
information will help registrants and growers to better understand how EPA identified species
for these actions and how EPA selected the proposed mitigations. Although this effort starts with
the pesticides/pesticide classes listed above, it will expand to other pesticides in registration
review based on staff capacity. As this effort expands, it will benefit from EPA's vulnerable species
initiative and the federal interagency mitigation pilot project, both discussed in the mitigation
strategy section below.
Lead division(s): EFED, PRD, BEAD
Timing: In process
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Meet ESA obligations for new registrations for conventional pesticide ingredients
already registered or undergoing registration review
¦ Meet ESA obligations for all other registration review cases. EPA is also required to complete
ESA determinations for the large number of registration review cases not covered by existing
court deadlines or currently in litigation. The first cycle of registration review covers over
450 conventional pesticide cases, but EPA is unable to complete most of the remaining ESA
determinations before the end of this cycle. Under this workplan, however, EPA will begin
developing a plan on when and how to make those determinations.
As explained in the earlier Background and Challenges section, the optimal order for making
those determinations will depend on the interplay between multiple factors. Those factors may
include:
~ How a pesticide affects listed species and critical habitat.
~ The amount of use for a pesticide that overlaps with listed species and critical habitat,
especially EPA-identified vulnerable species.
~ Early mitigations EPA incorporates that benefits species affected by a pesticide, even
before EPA has completed consultation, following public comment and notification
procedures under FIFRA.
~ Coordination of mitigation on newly registered pesticides and the existing pesticides they
are intended to replace, including through any discussions with USDA and pesticide users.
~ Process efficiencies that allow EPA to group multiple pesticides or classes of pesticides for
concurrent ESA determinations and formal consultation.
~ EPA capacity and infrastructure to make ESA effects determinations.
Developing an efficient ESA schedule that balances these and other factors presents a major
challenge for EPA. For this reason, the Agency cannot currently set a timeline for when it can
conduct ESA assessments for all the pesticides currently in registration review. The Agency,
however, does appreciate the importance of providing a timeline and clear commitments
about when these assessments will occur. During the next year, the Agency will continue
working toward a timeline. As part of this process, the Agency may determine the order in
which it will complete ESA assessments for each conventional chemical, even if it cannot
yet identify the dates for the assessments.
Lead division(s): EFED, PRD, BEAD
Timing: In process
¦ Adopt mitigation for vulnerable species. Through EPA's vulnerable species effort (see mitigation
strategy below for more information) EPA will identify and incorporate early ESA mitigation for
those species as part of registration review. This effort is also designed to benefit other ESA
species not covered by the vulnerable species effort.
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¦ Adopt flexible mitigation. EPA will identify and offer pesticide users more flexible approaches to
mitigating for effects to listed species (see mitigation strategy below for more information).
¦ Coordinate mitigation between new registrations and registration review. EPA will coordinate
mitigation measures on new conventional pesticide active ingredient registrations and related
registration review conventional pesticides, to help ensure consistent mitigation among
pesticides that cover similar uses (see mitigation strategy below for more information).
Meet ESA obligations for new use registrations, section 18 emergency use
registrations, and other actions on existing conventional pesticides
EPA will develop a strategy to meet its ESA obligations, as needed, for the large number of actions that
its registration program receives under PRIA and FIFRA. These include new uses for an existing pesticide,
requests for label amendments to an existing pesticide, new product combinations or physical form,
temporary permission for an unregistered use in response to a pest emergency under FIFRA section 18,
and other FIFRA actions, all of which may invoke ESA obligations. Collectively, these actions far exceed
the number of registration review decisions. New food use requests for existing chemicals are especially
important to agriculture and have averaged approximately 140 decisions per year. New products and
amendments also have a high volume (about 700) of decisions annually.
With the current approaches to ESA determinations and existing agency capacity, EPA is currently unable
to meet its ESA obligations for all the large number of new uses, section 18s, and other registration
actions. A major reason is that over the next six or more years, EPA has prioritized its workload on ESA
assessments for registration and registration review cases needed to meet settlement agreements. New
uses, section 18s, and other FIFRA actions will generally be lower priority during this period. Thus, EPA
will need to develop considerably more efficient ESA approaches for those FIFRA actions, as its approach
for new active ingredients is not designed to apply to the actions. EPA will develop the approaches after it
makes progress on the three types of FIFRA actions described earlier. As EPA develops more experience
incorporating ESA mitigation through registration of new active ingredients and registration review, it will
use this experience to inform mitigation for the FIFRA actions described in this section. Over the long-
term, EPA envisions that it can complete enough consultations for commonly used pesticides, so that the
Agency can update those consultations to include the other FIFRA actions.
In the meantime, EPA will continue to determine, on a case-by-case basis, how best to address its ESA
obligations for these other FIFRA actions. The one exception is new uses for herbicides used on crops
genetically engineered for tolerance to those herbicides. For those uses, EPA will continue to meet its
ESA obligations by making ESA determinations, initiating consultation as appropriate, and requiring any
necessary mitigation before a registration is granted.
Lead division(s): RD, EFED, BEAD
Timing: Case-by-case decision for all FIFRA actions, with development of comprehensive strategy
no sooner than 3 years.
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Meet ESA obligations for antimicrobial and biopesticide registration and registration
review decisions
The ESA-FIFRA assessment methods that EPA has developed were designed for conventional pesticides,
rather than antimicrobials or biopesticides. Nonetheless, EPA has completed ESA determinations for
some antimicrobials and has often concluded "no effect" because many antimicrobials are used indoors
and thus have no direct or indirect exposure to listed species or critical habitats. Similarly, EPA has been
able to find "no effect" for some biopesticides based on lack of exposure or lack of toxicity to listed
species or critical habitats.
To further meet its ESA obligations in these areas, the Agency will develop ESA assessment methods for
antimicrobials and biopesticides that allow it to go beyond the may effect/no effect analysis. EPA does
not expect that all future antimicrobial and biopesticide assessments will result in "no effect," so the
Agency will need to consider how to assess any potential "likely to adversely affect" determinations for
those pesticides and to require early and flexible mitigation. As part of this process, EPA will work with
stakeholders to determine when higher tier toxicological data may be needed to support any needed
biopesticide or antimicrobial biological evaluations.
EPA will learn important information through the process for addressing ESA obligations in the new
conventional pesticide actions. This will inform EPA's development of the process for non-conventional
pesticide actions.
To implement these obligations, EPA will:
Develop ESA approaches for biopesticides. Many biopesticides are used similarly to
conventional pesticides, so EPA expects to adapt some of the approaches for conventionals to
biopesticides, although EPA may also need to develop ESA approaches specific to biopesticides.
EPA will describe in any new approaches how the Agency will determine whether a biopesticide
"may affect" and is "likely to adversely affect" ESA species and critical habitats.
Lead division(s): BPPD, EFED
Timing: Within 18 months
Meet ESA obligations for biopesticides. EPA will adopt policy and program improvements, similar
to those for conventional pesticides, to help meet its ESA obligations for biopesticides. These
include early and flexible mitigation, and coordination between registration and registration
review of biopesticides. EPA plans to use pilot chemical(s) to demonstrate these approaches. EPA
will also start reaching out to biopesticide stakeholders who are likely unfamiliar with the ESA
process and EPA's obligations.
Lead division(s): BPPD
Timing: Pilots ongoing; significant progress on overall action within 18 months
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Develop ESA approaches for antimicrobials. EPA will develop ESA approaches specific to
antimicrobials. This will describe how the Agency will determine whether an antimicrobial "may
affect" and is "likely to adversely affect" listed species and critical habitats. The EPA will try to
use data from available sources to help identify the location of potential use sites (e.g., NPDES
permits for industrial uses; marina locations for anti-fouling paint uses) and work towards
refining available exposure models that will allow EPA to quantify risk to species. EPA will also
develop a list of antimicrobial use sites that are not expected to result in any outdoor exposures
(e.g., indoor uses that do not go down the drain) for which the EPA can make "no effect"
determinations.
Lead division(s): AD, EFED
Timing: 3 years
Meet ESA obligations for antimicrobials. EPA will adopt policy and program improvements,
similar to those for conventional pesticides, to help meet its ESA obligations for antimicrobials.
These include early and flexible mitigation, and coordination between registration and
registration review of antimicrobials. EPA plans to use pilot chemical(s) to demonstrate these
approaches. EPA will also start reaching out to antimicrobial pesticide stakeholders who are
likely unfamiliar with the ESA process and EPA's obligations.
Lead division(s): AD
Timing: Within 5 years
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STRATEGY 2: IMPROVE APPROACHES TO ESA MITIGATION
This section describes actions that support the mitigation measures that EPA will incorporate into its
registration and registration review decisions, including those resulting from litigation-related deadlines.
The implementation and rollout of these actions will vary, depending on the nature of each action. Some
actions will be announced through an EPA press release or OPP Update, while other actions do not warrant
a standalone announcement and will simply be incorporated into future EPA decisions.
Identify and incorporate early mitigation for vulnerable ESA species
EPA will identify and implement early mitigation for vulnerable ESA species, so that the Agency can
incorporate the mitigation into its registration and registration review decisions that require ESA mitigation.
The goal of this effort is to ensure that EPA is beginning to adopt meaningful protections for species most
affected by pesticide use, without the Agency waiting until consultation with the Services is completed.
Early mitigation for vulnerable species will also expedite any future pesticide consultation that covers those
species, because much of the mitigation needed for those consultations may have already been identified
through the vulnerable species effort discussed in step 1 below. Early mitigation for vulnerable species
entails three related but distinct steps: (1) identify vulnerable species, (2) identify mitigation for those
species, and (3) incorporate mitigation into FIFRA decisions.
The three steps are described below.
¦ Step 1: Identify vulnerable species. Throughout this workplan, "vulnerable species" refers to the
subset of ESA species that EPA is currently identifying based on characteristics of the species
or its habitat that predisposes it to experiencing pesticide effects. Those characteristics include
extent of range in proximity to pesticide use sites, sensitivity of species to pesticidal effects (e.g.,
insecticide's effects on insects), ability of species to recover from effects, and identification of
pesticides as a contributor to a species' declines in ESA recovery documents. EPA expects to
publish its working list of vulnerable species in the near future.
When EPA predicts the likelihood of a future jeopardy or adverse modification finding, that analysis
is specific to the pesticide at issue. This is a major difference between those predictions and
the identification of vulnerable species, which are not pesticide specific. EPA may predict a high
likelihood of jeopardy/adverse modification even for ESA species not on the vulnerable species list.
The reason is that the specific interaction between a particular pesticide use and a species may
reveal a high likelihood of jeopardy, which was not evident without the pesticide-specific analysis.
Conversely, EPA may not predict a species on the vulnerable species list as having a high likelihood
of jeopardy/adverse modification for a particular pesticide because, for example, the species range
may not overlap with the pesticide's registered uses.
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Step 2: Identify mitigation for vulnerable species. EPA intends to identify early mitigation for
vulnerable species through two approaches. First is through EPA's internal efforts to determine
suitable mitigation for each vulnerable species, based on ESA documents for the species,
ecological principles, coordination with Services biologists, and other ESA-FIFRA efforts. These
mitigation measures are not specific to a particular FIFRA action but instead designed to address
effects from most pesticides to which the species may be exposed.
Second is through a federal mitigation pilot project with the Services and USDA. Through this
pilot, the agencies will develop approaches for identifying and implementing mitigation earlier in
the ESA-FIFRA process for select species particularly vulnerable to pesticides. The Services have
selected approximately 20 species for the pilot, and EPA has selected an herbicide, an insecticide,
and a fungicide with uses that overlap with these species. For each species, the agencies will
develop an initial list of suitable mitigation measures to reduce the likelihood of a future jeopardy
or adverse modification finding and to minimize the effects of incidental take. The initial list may
be based on existing mitigation measures the Service(s) have developed and conservation actions
in recovery plans and other ESA documents (e.g., recovery outline, 5-year status review, species
status assessment), and will reflect input from species experts. Based on additional input from
USDA, registrants, pesticide users, conservation organizations, and others, the agencies will
identify the most feasible and effective mitigation measures from the initial list to create a refined
list of mitigation measures to incorporate into FIFRA and ESA decisions. The agencies will also
assess the success of the refined mitigation measures and expand the approach to include other
pesticides and species. The agencies will provide more details on the pilot project later in 2022.
Relationship Among the Three Categories of Species for Targeted Mitigation
Figure 4. Currently, EPA is compiling a list of vulnerable species based on characteristics of the
species or their habitat that predisposes them to pesticide effects. Some of those species are also
likely to be at risk of a future jeopardy finding for certain pesticides. But not all species facing a
future jeopardy risk have been identified as vulnerable species. All species selected for the federal
mitigation pilot project are vulnerable species and some may be at risk of a future jeopardy finding,
absent adequate early mitigation. Because the number of species represented by each of the circles
has not yet been determined, the size of the circles are not proportionally accurate. Further, the
extent of overlap among the inner circles will depend on various factors that EPA is still assessing.
Species with J/AM
determinations from
individual pesticide
evaluation
Species included in
federal mitigation
pilot project
Species identified as
* being particularly
vulnerable to
pesticide exposure
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Step 3: Incorporate any necessary ESA mitigation into FIFRA actions. EPA expects to incorporate
the identified necessary mitigation measures for vulnerable species into any relevant FIFRA
action that invokes ESA obligations. This may include registration of new pesticide active
ingredients, registration review, and other registration actions. Further, the measures can
be incorporated in any of the following stages of the FIFRA process, before the completion of
consultation:
~ Mitigation required to meet the FIFRA standard, before EPA completes a biological
evaluation or before the Services complete their biological opinions.
~ Mitigation as part of a FIFRA action where EPA has made a "may affect" finding.
~ Mitigation as part of a FIFRA action where the Agency has made an ESA likely to adversely
affect finding. This includes when EPA finds likely to adversely affect but is unable to
complete formal consultation with the Service(s) prior to registering a new active
ingredient.
As EPA continues identifying vulnerable species and any necessary mitigation for them, it
will explore how to apply those measures. In general, EPA intends to apply the mitigation
measures for vulnerable species as broadly as feasible. For example, effective, practical
mitigation measures that protect a listed insect species from an insecticide may apply across all
insecticides. Depending on the type of mitigation, EPA may first need to complete public notice
and comment (e.g., voluntary use deletions).
Lead division(s): EFED, RD, PRD, BEAD
Timing: In process for some FIFRA actions
Focus pesticide consultation process on adopting mitigation for species likely to
receive a jeopardy or adverse modification determination
To streamline the pesticide consultation process and to address species most affected by pesticides,
EPA will prioritize mitigation for species most likely to receive a jeopardy or adverse modification finding
during formal consultation. Because both findings focus on effects to species survival and recovery
(rather than effects only to individuals of a species, as is the case with "may affect" and "likely to
adversely affect" findings), EPA must perform some analysis of those species-level effects before
initiating formal consultation with the Services.
This approach will entail two shifts in how the Agency conducts its ESA-FIFRA analyses. First, as part
of EPA's effects determinations for certain pesticides, the Agency will assess population-level effects
to inform (1) the likelihood of a jeopardy or adverse modification finding during formal consultation
and (2) mitigation to address those effects. This approach will help ensure that EPA's assessments are
relevant to the ESA's goal of recovering species. It should also reduce the overall length and complexity
of consultations.
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Thus, although EPA needs to make trade-offs in the type of analyses it performs, the Agency expects
those tradeoffs to improve its ability to meet its ESA obligations more expeditiously and to adopt more
meaningful mitigation. Nothing about this new approach is intended to lessen the Services' role under
the ESA or to abrogate EPA's duty to issue effects findings or consult with the Services.
The second shift is that EPA seeks to work with the Services to expedite formal consultation for species
that benefit from early mitigation such that the likelihood of jeopardy or adverse modification becomes
negligible or nonexistent, but that still trigger a "likely to adversely affect" finding. In practice, "likely to
adversely affect" is triggered if even one individual of a species is likely to experience incidental take.
This is the case regardless of the species' recovery status or the overall effects of the proposed action
on a species. As a result, for certain species that are wide ranging or that occur near agricultural lands,
a likely to adversely affect may be unavoidable even with early mitigation and even if the probability
of jeopardy or adverse modification is very low or none. In those situations, EPA seeks to work with
the Services to expedite formal consultation for those species, thus creating a tangible incentive
for registrants to offer early mitigation to minimize the probability of future jeopardy and adverse
modification findings. This approach will require the agreement of both Services.
Lead division(s): EFED, RD, PRD, BEAD
Timing: In process
Identify flexible mitigation for all ESA species
When EPA gives registrants and pesticide users more flexibility in identifying ESA mitigation, those
measures are more likely to be implemented. EPA can offer more flexibility in at least two ways. One
is by engaging users and registrants earlier in the FIFRA process to identify and adopt suitable ESA
mitigation, based on input from those stakeholders about effective mitigation techniques that work best
for them. Another is by creating a menu of mitigation that users or registrants can select from, similar to
the approach taken by NMFS in recent pesticide biological opinions. A more comprehensive approach
for developing mitigation options is to gather information from species experts about effective mitigation
techniques and from pesticide registrants and users about techniques that are practical to implement.
For both options, EPA anticipates working with the Services on how best to determine the amount of
mitigation necessary to meet ESA obligations, and with USDA and other groups (e.g., American Mosquito
Control Association, National Agricultural Aviation Association, and university and extension researchers)
on how best to engage with pesticide users to identify and implement mitigation, including existing
conservations practices. To promote flexible mitigation, EPA will pursue the following two actions.
Start with federal mitigation pilot project. As described above, EPA is developing menus of
mitigation options with the Services and USDA through a pilot project for select species and
pesticides. EPA plans to incorporate lessons learned from this pilot to registration review
chemicals that overlap with other species that face the likelihood of a future jeopardy or adverse
modification finding. EPA hopes the federal pilot will provide additional insight on opportunities
to engage pesticide users and registrants on mitigation earlier in the FIFRA registration review
process, thereby improving EPA's ability to meet its ESA obligations.
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Start with federal mitigation pilot project (cont.). Additionally, as EPA incorporates early
mitigation for new conventional pesticide registrations and for the pilot pesticides in registration
review (discussed earlier) and completes consultations, it anticipates the resulting mitigations
will likely apply to other pesticides and will form the basis of mitigation menus for those
pesticides. For example, EPA recently developed a menu of mitigation to address run-off from the
herbicide Enlist that may also serve as a starting point to address the effects of run-off to listed
species and their critical habitat from other mobile herbicides.
Lead division(s): EFED, RD, PRD, BEAD
Timing: In process
Expand to other pesticides and species. EPA will work with the Services and USDA to expand the
actions in the efforts described above to other conventional pesticides and other species.
Lead division(s): RD, PRD, EFED, BEAD, BPPD
Timing: Within 2-3 years
Coordinate mitigation between registration and registration review decisions
EPA supports the registration of newer chemistries that likely have lower environmental and human
health risks. This is one reason that EPA is prioritizing resources to meet its ESA obligations for
registration of new active ingredients, especially those designed to replace older chemistries that have
greater effects on ESA species. This approach, however, can impose ESA mitigation for those pesticides
before mitigation is imposed on a corresponding older pesticide used for the same purposes (e.g.,
where ESA consultation on the older pesticide has not yet occurred), and in some cases, the older
pesticide may have a more harmful health or environmental profile. This disparity in mitigation may be
seen as incentivizing use of the older pesticides, because the older pesticide may not have as many use
restrictions. The disparity may also be seen as discouraging the development of new pesticides if they
are restricted more than older pesticides, thus possibly reducing their market share. To address these
problems, EPA will begin coordinating ESA mitigation between new pesticides and corresponding older
pesticides.
To identify these pairings, EPA will need to match new and older pesticides based on crop use,
target pests, timing of FIFRA and ESA reviews, registrants, and other factors. EPA does not yet have
a framework for this type of assessment, so will begin piloting an approach in 2022 through a new
pesticide registration decision that the Agency will link to a corresponding conventional pesticide in
registration review. This could include new biopesticide registrations that lead to reduced use of existing
conventional pesticides with more significant effects on ESA species. EPA will then evaluate how to
coordinate its ESA mitigation more broadly between its registration and registration review decisions.
Lead division(s): RD, PRD, EFED, BEAD, BPPD
Timing: Begin within 12 months
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Use compensatory mitigation (offsets) to supplement avoidance and minimization
To meet ESA obligations, federal agencies often use compensatory mitigation (also known as offsets)
to address the effects of their actions that cannot be avoided or minimized. Offsets can include actions
such as habitat preservation or restoration, invasive species control, and species reintroductions. These
actions directly further species recovery (sometimes more than on-site avoidance and minimization)
and should provide registrants with greater flexibility by creating more options for EPA to meet its ESA
obligations. EPA will thus identify opportunities for offsets to complement traditional FIFRA avoidance
and minimization measures for ESA species. The Agency will do so through a multistep process
that includes working with the Services to develop general guidance on using offsets for pesticide
consultations, working with registrants to identify and adopt offsets for specific pesticides and species,
ensuring that adopted offsets are legally binding as a condition of a FIFRA registration, and working with
the Services to oversee implementation of offsets. In 2022, EPA will be working to pilot the use of offsets
for certain chemicals and species, in cooperation with registrants who are seeking to include offsets in
their registration. Based on these pilots, EPA seeks to work with the Services to clarify the process for
incorporating offsets into pesticide consultations and scaling up that process to handle large numbers of
species and pesticide actions.
Lead division(s): EFED, PRD, RD, BEAD
Timing: Pilot projects in 2022
Pursue other policy and program improvements that support mitigation
Require Bulletins Live! Two language on certain pesticide labels. Bulletins Live! Two is EPA's
web-based system for incorporating geographically specific restrictions for ESA species and
critical habitats. To help meet ESA obligations, especially for conventional pesticides that EPA
registers before completing formal consultation, EPA expects to require that certain labels for
new conventional registration actions, certain non-conventional registration actions, and many
registration review actions include language directing users to check Bulletins Live! Two for
restrictions that the user must follow before applying a pesticide. For example, when EPA expects
that a pesticide in registration review may require mitigation implemented through Bulletins, the
Agency will seek Bulletins language as part of the label it approves through an Interim Decision.
Because EPA will not be able to immediately populate Bulletins with mitigation for all listed
species affected by approved pesticide uses, the Agency will prioritize developing mitigation for
EPA vulnerable species and species covered by the interagency mitigation pilot project, both
discussed earlier. To facilitate EPA's efforts to adopt mitigation for these species, the Agency
is considering the option to retract or revise the antiquated 2005 Federal Register Notice on
its Endangered Species Protection Program (OPP-2002-0311). The reason is that much has
changed since 2005 about how EPA addresses its ESA obligations, and the Agency seeks to
update and modernize its guidance.
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Require Bulletins Live! Two language on certain pesticide labels (cont.). The Agency is also
considering rulemaking in the future to require the Bulletins language on all or a subset of all
labels, where that language is necessary, thus standardizing the use of the language across
labels that require spatially explicit mitigation. Incorporating the language where necessary
also helps with the legal defensibility of EPA's registration and registration review decisions
and reduces agency resources to update labels after formal consultation has concluded and
a biological opinion is finalized. This approach will also facilitate adopting timely mitigation
because the pesticide labels in commerce will already contain the requirement to follow Bulletins
when EPA issues the Bulletin language, thus bypassing the lengthy process from EPA approval of
a label to field implementation of that label, which typically takes 18 months or longer.
Lead division(s): RD, PRD, BPPD
Timing: In process
Update Bulletins Live! Two. Given that Bulletins Live! Two will be the main interface for conveying
most future geographically specific ESA label restrictions, EPA will upgrade the interface to be
more user friendly. In February 2022, EPA completed initial updates to Bulletins. The Agency will
continue identifying additional updates to implement over the coming years.
Lead division(s): EFED
Timing: Ongoing
Adopt electronic labeling system. In the longer term, EPA will focus on shifting to an electronic
labeling process that supports quicker label revisions during registration and registration
review, in implementing non-geographic mitigations in biological opinions, and that may replace
Bulletins Live! Two with a more comprehensive system for conveying ESA label restrictions. EPA
has been working for several years to set up an electronic labeling program, but implementing
the program may require rulemaking, transitioning labels to the electronic system, and other
major administrative actions that will span 3-5 years. In the meantime, EPA is considering
whether pilot projects with willing registrants can demonstrate how electronic labeling can
streamline label amendments that incorporate ESA mitigation.
Lead division(s): PRD, RD, EFED, BPPD, other OCSPP divisions
Timing: No earlier than 2 years
Develop policies or processes to integrate meeting ESA obligations into FIFRA decisions. To
streamline the ESA-FIFRA program, EPA will consider policies that integrate meeting its ESA
obligations into the FIFRA process. EPA will be considering issues such as the situation where
the Agency determines that a registration may present a high likelihood of jeopardy or adverse
modification, EPA may find that the application does not meet the FIFRA approval standard
without adequate mitigation because of ESA concerns.
Lead division(s): OCSPP, OPP
Timing: Within 2 years
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Use existing conservation practices to inform ESA mitigation. Many landowners are likely
implementing stewardship and best management practices to reduce pesticide drift and runoff,
but those practices are not often identified and incorporated into EPA's risk assessments nor
consistently used to inform ESA mitigation. By addressing this gap, EPA can develop mitigation
that landowners are more likely to be familiar with and effectively implement. EPA will work
with the Services, USDA, and stakeholders to develop a plan to identify pesticide stewardship
practices that EPA and the Services are not currently considering in pesticide consultations, and
then determine how best to incorporate that information into the consultation process.
Lead division(s): BEAD, EFED
Timing: Within 3 years
Evaluate ESA section 7(a)(1) conservation program for pesticides. Section 7(a)(1) of the
ESA requires all federal agencies to use their authorities to help conserve ESA species and
complements the section 7(a)(2) requirement for agencies to consult with the Services to avoid
jeopardy and adverse modification. How agencies fulfill their section 7(a)(1) duty, however, is
flexible and open-ended (e.g., the Services have no regulations on section 7(a)(1)). EPA will
consider developing a section 7(a)(1) approach for its pesticide program that can help with
meeting its section 7(a)(2) obligations. For example, EPA could work with registrants, pesticide
users, and the Services to adopt proactive conservation that, if implemented and shown to be
effective, can be incorporated into future pesticide consultations. In this case, USDA could help
identify these conservation practices and then EPA could work with the Services and USDA to
determine how future pesticide consultations should account for the practices. This approach
should also help expand the use of offsets in pesticide consultations. A section 7(a)(1) program
could also help address species research needs to inform future pesticide consultations (e.g.,
effectiveness of specific mitigation techniques). EPA proposes to work with the Services to
identify the various opportunities for a section 7(a)(1) program to benefit EPA's ESA-FIFRA work
and determine whether and how to pursue those opportunities.
Lead division(s): EFED, PRD, RD, OCSPP 10
Timing: Within 3 years
Coordinate on research. OPP will continue coordinating with EPA's Office of Research and
Development to help ensure that its research can inform the ESA-FIFRA process. Current
coordination already covers important questions on species risk assessments. The two offices
may consider expanding this work to cover ESA mitigation and other emerging topics important
to ESA pesticide consultations. EPA also envisions coordinating on research with other federal
agencies and with academic institutions. In particular, EPA will explore work with the NMFS
Northwest Fisheries Science Center on pesticides research, given the Center's long history of
pesticide research and their science support for NMFS biological opinions. All these efforts will
increase the resources for improving the scientific foundation of pesticide consultations.
Lead division(s): EFED
Timing: In progress
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STRATEGY 3: IMPROVE INTERAGENCY CONSULTATION PROCESS
Although progress has been made over the last decade, over the next decade far more improvements to
the pesticide consultation process are needed to keep pace with EPA's ability to meet its ESA obligations,
including for the large backlog of conventional pesticides in registration review. The current consultation
process does not optimize use of EPA resources or optimally engage stakeholders, irrespective of resource
levels. Improving the consultation process, however, requires considerable interagency coordination; EPA
cannot accomplish any of the actions on its own. This section describes how EPA seeks to work with the
Services to improve the efficiency of the consultation process.
EPA has determined that the current approach to consulting on individual pesticide ingredients cannot
efficiently scale to the hundreds of pesticides that EPA must assess under the ESA within the next decade.
This inefficiency applies not only to the individual ESA determinations that EPA must make, but to the
process of developing and implementing mitigation. Based on its experience with current and upcoming
pesticide consultations, EPA will coordinate with the Services to develop more efficient approaches
to consulting on pesticides. For example, programmatic consultations for groups of pesticides (e.g.,
herbicides) or for all pesticides that share similar use patterns in a region would enable mitigations to be
identified together and would be far more efficient than the current pesticide-by-pesticide approach. This
approach also avoids the problem of imposing disparate mitigation requirements across pesticides with
similar use patterns.
Another example is for EPA to consider consulting with certain regional or field offices of the Services for
a pesticide used only in a region, in coordination with the agency's headquarters staff. Although there are
barriers to this approach, which would first require Services agreement, there are also benefits such as
working directly with the Services biologists who may have connections to the landowners who implement
mitigations. In the past, EPA has successfully consulted with FWS headquarters and a regional office on
two rodenticides (Rozol and Kaput).
Developing alternatives to the current approach to pesticide consultations will require EPA and the
Services to address various logistical and legal issues, all of which take time. EPA, however, sees no choice
but to identify more efficient approaches that enable each consultation to cover far more pesticides or that
the agencies can complete in far less time than under the current approach.
Lead division(s): EFED, RD, PRD, BEAD
Timing: In process
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STRATEGY 4: IMPROVE STAKEHOLDER ENGAGEMENT
Stakeholder engagement is crucial not only to providing transparency about EPA's work, but also for
stakeholders to help with ESA-FIFRA improvements. Registrants and pesticide users will especially benefit
from many of these improvements that increase the predictability and speed of pesticide consultations.
Obtain data for ESA assessments
In some cases, EPA may lack sufficient data to begin an ESA assessment or complete one efficiently. In
these situations, EPA will work with registrants and others to obtain the necessary data before the start
of the assessments. This will likely include use and usage data, where applicable, and recommendations
on when and how to incorporate those data into ESA determinations. For example, state agricultural
extension agencies and USDA may be able to inform EPA about anticipated uses of a new active ingredient
for which no usage data exist. EPA may also issue new Data Call-in notices, especially for antimicrobial and
biopesticides, to seek data needed for its ESA determinations. In those situations, EPA will also update its
Information Collection Request that describes the type of information EPA seeks, the reasons for seeking
the information, and the time and cost for the public to provide the information. EPA is also considering
issuing a Pesticide Registration Notice to help registrants draft labels that consider ESA mitigation and
to discuss other approaches to facilitate the adoption of mitigation. Further, through EPA's quarterly
registration review schedule, the Agency may notify stakeholders of upcoming data needs for pesticides in
registration review.
Lead division(s): PRD, RD, EFED, BEAD, BPPD, AD
Timing: No earlier than 12 months
Expand engagement with growers through USDA
Growers have an important stake in the outcome of many FIFRA actions and an important role in growing
our nation's food and protecting its natural resources. EPA already works with growers on a variety of
pesticide matters and envisions a larger role for growers to offer information to support FIFRA actions
and ESA determinations and mitigation decisions. EPA views USDA as an important conduit for growers
to provide this information and will work with the agency to identify process improvements for grower
engagement, including through the federal pilot project described earlier.
Lead division(s): PRD, RD, EFED, BEAD, BPPD
Timing: In process
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Expand engagement with non-agricultural organizations
EPA already works with non-agricultural organizations that have an interest in ESA-FIFRA issues. This
includes environmental, tribal, and public interest organizations, as well as organizations that represent
pesticide users (e.g., American Mosquito Control Association, National Pest Management Association).
EPA will expand its engagement with non-agricultural organizations on specific ESA-FIFRA issues and
improvements to the ESA-FIFRA process.
Lead division(s): PRD, RD, EFED, BEAD, BPPD
Timing: Beginning within the next 12 months
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CLOSING
AND FUTURE STEPS
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CLOSING AND FUTURE STEPS
Through this workplan, EPA's Pesticide Program hopes that readers appreciate its strong commitment to
addressing its historic lapses in fulfilling its ESA obligations. The Program's vision statement will guide
the workplan as the Agency works through the monumental backlog of FIFRA actions that require ESA
review, compounded by ongoing and future FIFRA actions. The Program understands the limitations
of its current capacity and expertise and has taken steps to start addressing this challenge. These
steps include major process improvements, many of which depend on collaboration with the Services,
USDA, and stakeholders. This workplan is EPA's most comprehensive effort to date that describes the
improvements it will pursue and the external partnerships it is seeking.
EPA welcomes feedback from stakeholders about the workplan and particularly about opportunities
to partner with EPA on implementing the highest priority actions in the document. Through those
partnerships, EPA expects that it can increase the number of ESA assessments it completes on its
own without the need for litigation to compel this work, deliver more meaningful conservation for listed
species, and offer pesticide registrants and users more practical and flexible mitigation to protect those
species.
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APPENDIX A
CURRENT SCHEDULE FOR
ESA DETERMINATIONS AND
IMPLEMENTATION OF NMFS SALMONID
BIOLOGICAL OPINIONS
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APPENDIX A
CURRENT SCHEDULE FOR ESA DETERMINATIONS AND IMPLEMENTATION
OF NMFS SALMONID BIOLOGICAL OPINIONS
EPA has the following court-enforceable deadlines and other agreements (not yet court-enforceable)
for ESA determinations and biological evaluations (BE). Pending litigation may add other deadlines to
this schedule. The table includes EPA's expected/known timing to complete its biological evaluations as
well as work to implement some recent biological opinions from U.S. Fish and Wildlife Service (FWS) or
National Marine Fisheries Service (NMFS). "TBD" indicates that timing has not yet been determined for
the specified step in the process.
Each date (or TBD) in the table is either green, yellow, or red, where: green = completed; red = expected/
planned future work; and yellow = expected/planned future work for pesticides without ESA litigation.
Chemical
EPA Draft BE
EPA Final BE
Court Enforceable or Court Committed Dates
Methomyl
2020
2021
Carbaryl
2020
2021
Atrazine
2020
2021
Simazine
2020
2021
Glyphosate
2020
2021
Propazine1
2020
NA
Enlist One
NA
2022
Enlist Duo
NA
2022
Imidacloprid
2021
June 2022
Clothianidin
2021
June 2022
Thiamethoxam
2021
June 2022
Sulfoxaflor
NA
Spring 2022
Inpyrfluxam
NA
2023
Cyantraniliprole
2023
2023
Dinotefuran
2023
2024
Acetamiprid
2023
2024
Brodifacoum
2023
2024
Warfarin
2023
2024
Bromadiolone
2023
2024
Zinc phosphide
2023
2024
Chlorophacinone
2023
2024
Diphacinone
2023
2024
Difenacoum
2023
2024
Bromethalin
2023
2024
Difethialone
2023
2024
Cholecalciferol
2023
2024
Flupyradifurone
2024
2025
Bicyclopyrone
2024
2025
Streptomycin
2025
20262
Benzovindiflupyr
2026
2027
Halauxifen-methyl
2026
2027
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APPENDIX A
CURRENT SCHEDULE FOR ESA DETERMINATIONS AND IMPLEMENTATION
OF NMFS SALMONID BIOLOGICAL OPINIONS
Chemical
EPA Draft BE
EPA Final BE
Expected BE Completion Dates
Approximately 10 new
active ingredients
2022
2022/2023
Acephate
2026
2026
Dimethoate
2026
2026
Naled
2026
2026
Tribufos
2026
2026
Bensulide
2027
2027
Ethoprop
2027
2027
Phorate
2027
2027
Phosmet
2027
2027
Active Ingredients in Pending Litigation Without Current Commitments
1,3-D (Telone)
TBD
TBD
2,4-D
TBD
TBD
Captan
TBD
TBD
Chlorothalonil
TBD
TBD
Dicamba
TBD
TBD
Diuron
TBD
TBD
MCPA
TBD
TBD
Mancozeb
TBD
TBD
Metolachlor
TBD
TBD
Metribuzin
TBD
TBD
Oxyfluorfen
TBD
TBD
Paraquat
TBD
TBD
Pendimethalin
TBD
TBD
Propanil
TBD
TBD
Propargite
TBD
TBD
Phosphorotrithioate
TBD
TBD
Thiobencarb
TBD
TBD
Trifludimoxazin3
TBD
TBD
Trifluralin
TBD
TBD
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APPENDIX A - continued
Recent Biological Opinions from the Services that EPA is Working to Implement
Chemical
FWS/NMFS
Final BiOp
1080
FWS
114
M-44
FWS
20214
Metolachlor5
NMFS
2021
Telone5
NMFS
2021
Prometryn5
NMFS
2021
Bromoxynil5
NMFS
2021
Malathion
FWS
2022
Diazinon6
NMFS
2022
Chlorpyrifos6
NMFS
2022
Malathion6
NMFS
2022
1 Propazine registrations were voluntarily cancelled; therefore, consultation was no longer
necessary.
2 No sooner than Fall 2026
3 Trifludimoxazin registrations are going through a voluntary cancellation process.
4 EPA re-initiated consultation on these two predacides in 2011; a biological opinion was not
necessary because the action was changed during the consultation process to avoid jeopardy.
Consultation was completed in December 2021.
5 Consultation was limited to salmonid species in the Pacific Northwest; EPA is working to
implement additional salmonid BiOps through the registration review process.
6 NMFS's 2022 BiOps are the result of a re-initiation process.
Many of the dates in this table are part of various settlement agreements and subject to change
depending on the terms of those agreements.
Some dates are not associated with settlement agreements and are subject to change pending
resources and prioritization.
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APPENDIX A - continued
Implementation of NMFS Salmonid Biological Opinions
EPA is currently working to implement the NMFS salmonid biological opinions #2, 4, and 7 in 2022 as
part of registration review proposed interim decisions (PID) or interim decisions (ID) for these pesticides.
EPA anticipates focusing on the next set of NMFS salmonid biological opinions once these three
biological opinions are implemented.
NMFS Biological
Opinion No. and
Year Issued
Chemicals
(strikeout = cancelled product)
Action/Status
2 (2009)
Carbaryl, Methomyl
Carbofuran,
In process, with initial steps in
2022
3 (2010)
Bensulide, Dimethoate, Ethoprop,
Naled, Phorate, Phosmet
Azinphos-methyl, Disulfoton,
Fenamiphos, Methamidophos,
Methidathion, Methyl parathion,
Implement through ID
4 (2011)
2,4-D, Captan, Chlorothalonil, Diuron,
Linuron, Triclopyr BEE
In process, with initial steps in
2022
5 (2012)
Oryzalin, Pendimethalin, Trifluralin
Implement through amended
IDs
6 (2012)
Thiobencarb
Implemented through Bulletins
Two! Live (2014)
7 (2014)
Diflubenzuron, Fenbutatin-oxide,
Propargite
In process, with initial steps in
2022
9 (2021)
Bromoxynil, Prometryn
Label amendments scheduled
for December 2022
10 (2021)
1, 3-dichloropropene (1,3-D),
Metolachlor
Label amendments scheduled
for December 2022
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APPENDIX B
PENDING ESA LITIGATION ALLEGING
FAILURE TO MAKE EFFECTS
DETERMINATIONS ON
FIFRA ACTIONS
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APPENDIX B
PENDING ESA LITIGATION ALLEGING FAILURE TO MAKE EFFECTS
DETERMINATIONS ON FIFRA ACTIONS
Litigation involving new actions to older chemicals for failure to consult:
• Center for Biological Diversity (CBD) v. EPA. No. ll-cv-00293-JCS (N.D. Cal.): "megasuit"
challenging 2200 products re 35 active ingredients
• National Research Defense Council (NRDC) v. EPA. No. 20-70787, (9th Cir,), registration
review of glyphosate. EPA is awaiting decision from the court.
Litigation involving new uses of existing pesticides
• Migrant Clinicians Network (MCN) v. EPA. No. 21-70719 (9th Cir.). Challenge to select
streptomycin registrations. Litigation is currently at briefing stage.
• Center for Food Safety (CFS) v. EPA. No. 19-72109 (9th Cir.). Challenge to registrations of
new uses of sulfoxaflor. Parties are awaiting decision from the court.
Litigation involving new Al registrations
• Center for Biological Diversity (CBD) v. EPA. No. 15-1054, (DC Cir.). Challenge to
registrations of new Als flupyradifurone, bicyclopyrone, and benzovindiflupyr, and
halauxifen-methyl. Parties are awaiting decision from the court.
• Center for Biological Diversity (CBD) v. EPA. No. 20-73146 (9th Cir.). Challenge to
inpyrfluxam registrations. Litigation is currently at briefing stage.
• Center for Food Safety (CFS) v. EPA. No. 21-71180, (9th Cir.). Challenge to trifludymoxazin
registrations, for which the registrant has requested voluntary cancellation.
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spi I
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