Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2018
Fifteenth Annual Report

Process Improvements in the Pesticide Program
Human Health Risk Assessments
Science Review Committees. Ensuring scientific integrity is at the core of the Pesticide
Program. Several established review committees routinely consider all manner of issues related
to the development of risk assessments. This includes review of risk assessments and their
component pieces. It also includes development of science policies and administrative processes
which enhance the ability of the organization to be more efficient and to complete quality,
science-based risk assessments in a more consistent manner. Some examples of science policies
have included requiring less residue data under certain conditions and development of more up to
date exposure metrics for evaluating some pesticide uses. The number of meetings for each
committee in 2018 is provided to illustrate the breadth of these activities. The Residues of
Concern Knowledgebase Subcommittee (ROCKS) continues to lead the application of predictive
Tox 21 tools for metabolites, residues, and environmental degradation products. In FY' 18, the
ROCKS reviewed 4 chemicals by conducting meetings and e-reviews. The Dose Adequacy
Review Team (DART) met once. The Cancer Assessment Review Committee (CARC) reviewed
5 chemicals. The Toxicology Science Advisory Council (ToxSAC) reviewed 50 packages in 46
meetings. The Risk Assessment Review Committee (RARC) reviewed 17 chemicals. The
Chemistry Science Advisory Council (ChemSAC) completed 22 meetings while the Dietary
Exposure Science Advisory Council (DESAC) reviewed 59 assessments in 12 meetings. The
Exposure Science Advisory Council (ExpoSAC) conducted 25 meetings and reviewed 81 non-
dietary exposure assessments.
Hazard and Science Policy Committee (HASPOC). As a forum to address science, policy,
hazard data waivers, and risk deliberation and coordination issues, the HASPOC was very active
again in 2018. HASPOC plays an important role in the implementation of the vision of the 2007
NAS report on toxicity testing in the 21st century  moving toward smarter testing strategies by
waiving toxicity studies that do not provide useful information. In FY' 18, HASPOC reviewed
data waiver requests for a variety of toxicity studies, primarily for comparative thyroid assay
(CTA), acute and subchronic neurotoxicity, developmental, reproductive, and subchronic
inhalation toxicity studies. Waivers were granted for 62 of 71 requests resulting in savings of
about 16,500 animals and approximately $8.9 million in the cost of conducting the studies.
Implementation of 21st Century Toxicology and Exposure Assessment: International
Collaboration, Integrated Approaches to Testing and Assessment, and Adverse Outcome
Pathways. Consistent with National Academy of Sciences (NAS) reviews, and in collaboration with
national and international bodies, EPA has continued to develop and implement 21st Century
toxicology and exposure methods, including computer-modeling and in vitro testing techniques, to
advance more efficient and effective risk assessments that support sound, risk-based, regulatory
decision-making. In 2018, EPA made significant progress toward implementing alternative methods
into regulatory use within the U.S. and around the world. The National Toxicology Program (NTP)
Interagency Center for the Evaluation of Alternative Toxicological Methods
(NICEATM)/Interagency Coordinating Committee on the Validation of Alternative Methods
(ICCVAM) held the 5th annual Public Forum. ICCVAM started a new technical workgroup on
ecotoxicology to help support the needs of EPA, Department of Interior, USD A, and other federal
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agencies. Office of Pesticide Programs (OPP) scientists published papers in scientific journals on
regulatory needs regarding alternative approaches related to ICCVAM activities. OPP helped co-
organized and attended a ICCVAM workshop hosted by the National Toxicology Program on
Predictive Models for Acute Oral Systemic Toxicity (
meetings/past-meetings/tox-models-2018/index.htmO that may, in time, support a computational
approach to the oral LD50. Collaborative work by EPA, NICEATM, Consumer Product Safety
Commission (CPSC), the European Union (EU) and Canada to develop a performance-based test
OECD guideline for skin sensitization continues to advance through the technical workgroup on
defined approaches. OPP in collaboration with OPPT released a new draft, interim science policy on
Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal
Testing ( )93-0090). This document
describes an approach using in vitro studies to eliminate the use of laboratory animals for skin
sensitization testing. OPP continued its pilot project requesting registrants voluntarily submit
Globally Harmonized System of Classification and Labelling of Chemicals (GHS) additivity
equation calculations for oral and inhalation formulation acute testing in combination with
submitting the actual study. This pilot is designed to test the performance of the GHS additivity
equation as a possible replacement for the animal study. NICEATM is also supporting OPP's
collaborative project with CropLife America (CLA) & Health Canada's Pest Management
Regulatory Agency (PMRA) related to the eye irritation and dermal irritation that will eventually
lead to scientific improvements in the "six pack".
OPP began developing metrics for the use of in vitro studies for the "six pack" in FY' 18.
Specifically, OPP received 25 in vitro eye irritation assays, 13 skin irritation assays, and one skin
sensitization assay. In addition, OPP received 18 waiver requests under the 2016 "Guidance for
Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective
Analysis." With these new tracking metrics, OPP will in the future be able to gauge the extent to
which new approaches and science policies are leading reductions in animal testing.
Preliminary eye irritation data from formulation testing across different agricultural formulation
types in multiple in vitro studies became available in 2018 and was used to inform the next stage of
prospective eye irritation testing.
In 2018, OPP and the Office of Pollution Prevention and Toxics (OPPT) developed the document
"Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact
Toxicity: A Case Study Using a New Approach Methodology (NAM)"
assessment-pointY This document describes the use of a 3-dimensional in vitro system using human
lung tissue coupled with computational fluid dynamic modeling as a possible replacement to
inhalation testing in laboratory animals. This document was released in FY' 2018 in preparation for
a meeting of the FIFRA SAP held in December 2018.
PBPK Collaboration. In 2018, OPP made significant progress towards implementing more
physiologically based pharmacokinetic (PBPK) models in our human health risk assessments. An
external panel of 10 members conducted a peer review to evaluate whether the PBPK models for
deltamethrin and permethrin and the PBPK/pharmacodynamic (PD) model for carbaryl submitted by
the registrants are appropriate for replacing/refining uncertainty factors applied in inter-species or
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age-dependent extrapolations. The panel had the required expertise (computational modeling,
toxicology/biology, risk assessment) to critically evaluated the model structure, parameterization,
coding and scientific credibility for use in human health risk assessment. Their final report, model
code and associated documents were posted in dockets EPA-HQ-OPP-2010-0230 (carbaryl), EPA-
HQ-OPP-2009-0637 (deltamethrin) and EPA-HQ-OPP-2011-0039 (permethrin). These models are
currently being revised to address reviewers' comments. Other registrants are collecting in vitro and
in vivo data to support the development of PBPK/PD models for malathion and dimethoate. These
models will also be used to replace/refine inter-species and age-dependent extrapolation factors.
OPP and the Office of Research and Development (ORD) are collaborating with a new HESI project
on developing best practices and approaches to PBPK model documentation/reporting, as well as
evaluating model for use in risk assessment. In 2018-2019, OPP is involved in two active HESI
tasks: (1) developing a template for modeler developers to report and submit their PBPK analysis to
regulatory agencies; and (2) developing a framework for evaluating PBPK models for various risk
assessment applications. Although this framework is initially developed for data-rich chemicals,
such as pesticides, it will be expanded in the next phases to include strategies for evaluating models
for data-poor chemicals.
Cumulative Risk Assessment Screening Framework. During FY'18, the Cumulative Risk
Assessment (CRA) Working Group has continued its efforts analyzing groups of pesticides for
potential common mechanisms of toxicity and developing cumulative risk screening
assessments utilizing the recently developed guidance document, Pesticide Cumulative Risk
Assessment: Framework for Screening Analysis Purpose. Specifically, it has determined that the
data for antibiotics, acyl aminoacids, chitin synthesis inhibitors, and dinitroanilines do not
support establishing a common mechanism group (CMG) and no further CRA work is
Comparative Thyroid Assay. In 2005, the EPA developed guidance for conducting a
comparative thyroid assay (CTA) that uses a mechanistic approach to generate thyroid-specific
data to address the uncertainties associated with life stage susceptibility and allow for the
establishment of points of departure that would be protective of the effects of thyroid function
disruption during potentially sensitive life stages (pregnancy, prenatal, and postnatal periods). In
FY' 16, HED worked with ORD to develop a set of criteria that can be used in a weight-of-
evidence approach to determine whether a comparative thyroid assay should be required for risk
assessment. This weight of evidence approach considers all relevant hazard and exposure
information (e.g., pesticide use pattern, toxicity profile, and margins of exposure). In FY' 18, the
Hazard and Science Policy Committee (HASPOC) used this approach to evaluate the need for a
comparative thyroid assay for 8 chemicals (2 required, 6 waived). Until these data are submitted,
a 10X uncertainty factor will be applied to all short-term, intermediate- term, and chronic
exposure scenarios. EPA continues to dialogue with stakeholders about the utility and conduct of
this study.
Dietary Exposure-Review of Proposed Crop Groups. EPA's ChemSAC reviewed proposals for
the following revised crop groups: root and tuber and leaves of roots and tubers and legumes and
foliage of legumes. Proposed rules based on these analyses are forthcoming.
Residue Chemistry-Streamlined Residue Chemistry Review of Import Tolerance Actions.
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Work has continued on a streamlined approach for establishing tolerances without accompanying
U.S. registrations (i.e., "import tolerances"). Instead of submitting the currently required residue
chemistry field trial data, the petitioner will submit the final review of the residue chemistry data
from the Joint FAO/WHO Meeting of Pesticide Residues (JMPR) or a National Authority. EPA
will rely on these reviews to determine the appropriate tolerance level with the intent of
harmonizing with the established Codex or National Authority MRL, provided the required safety
finding can be made. EPA will continue to accept these submissions on a trial basis to determine if
this a feasible approach and what the appropriate parameters would be to accept such submissions.
After previously evaluating several of these pilot petitions a determination was made that this is an
acceptable process and a flow-chart was developed for conducting these registration actions.
Residue Chemistry-Seed Treatment Policy. EPA in collaboration with PMRA, previously
performed a retrospective analysis of all seed treatment (ST) residue data that have been
submitted to EPA/PMRA and developed a tiered approach for determining if current data
requirements are appropriate or if streamlining is possible. A case study was also conducted to
understand potential savings. Potential savings were identified for both petitioners and EPA in
terms of conducting, submitting, and reviewing the studies while still obtaining the data
necessary to establish tolerances, as needed, using the proposed tiered approach. The policy
was published in 2018 (
Updated Occupational Exposure Metrics - Revisions to Unit Exposure (UE) Table.
Continuing a multi-year effort, OPP is maintaining the unit exposure surrogate table, a quick
reference guide that presents the current recommended unit exposures for standard agency
occupational pesticide handler exposure scenarios. OPP will continue to update this surrogate
reference table as additional pertinent exposure data become available from, for example, the
Agricultural Handler Exposure Task Force (AHETF), and other available registrant-submitted
exposure monitoring studies. This effort continues to ensure that all of the data sources used in
the surrogate table are compliant with applicable ethics requirements pursuant to 40 CFR 26. In
FY' 14 OPP began review of new data on backpack and handgun applicators from the AHETF
and in FY' 15 formally incorporated the new data into the reference table and our risk
assessments, superseding any previous datasets. In FY'16 work continued on related data,
including planned reviews of completed studies by the Human Studies Review Board and
completion of seed treatment handler data analysis. In FY' 17, AHETF data for wettable powder
and water-soluble packet formulations were reviewed, and handler UEs were updated. Where
revised UE data impacted post-harvest handler scenarios, they were updated as well. In FY' 18,
new exposure data from the AHETF was reviewed/approved and supplanted older monitoring
data as the data source for assessment of handlers manually loading granule pesticide
Policy Improvements for Non-Dietary Exposure Assessments. During FY'17, several
exposure policies were reviewed and updated to utilize the best available data and
assumptions. AHETF phase II seed treatment survey data for amount of seed treated were
incorporated into handler exposure assumptions. New methodologies were also implemented
to assess a range of potential dust to liquid ratio exposures for residential handlers of pet
collars. Policy or guidance documents that were drafted, updated, or finalized in FY' 17
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include the draft Residential SOP update to add residential exposures from aquatic-use
pesticides, the draft mosquito adulticide SOP for ground and aerial/ultra-low volume
application, and the revised commercial and on-farm seed treatment policy for the amount of
seed treated and planted per day. In FY' 18 OPP formally incorporated the respiratory
protection factor assumed by OSHA and NIOSH for filtering facepiece respirators (PF10:
90% inhalation exposure reduction) and finalized guidance on mapping pesticide application
records in the REJV consumer use pesticide survey to the "Residential SOP" exposure
assessment scenarios, a tool that can help assessors characterize characteristics of consumer
pesticide use such as application frequency.
OECD Activities. OPP continued to coordinate US Government participation in the Organization
for Economic Cooperation and Development (OECD) Test Guideline Program. The program
develops and updates test guidelines and guidance documents that are the most relevant for testing
the safety of chemicals. Harmonizing testing across the 34-member countries of the OECD can
reduce testing costs for industry since a study conducted under the test guidelines and Good
Laboratory Practices will be accepted for review by all member countries. The OECD harmonized
Test guidelines are the foundation of the global pesticide review process. Several new and updated
test guidelines and guidance documents were approved this year, including in vitro tests that avoid
testing on animals, studies that can be used to test toxicity of pesticides to bees, and tests that can
be used to test the efficacy of antimicrobial products, higher tier tests that support the Endocrine
Disruptor Screening Program (EDSP), and updated genotoxicity test guidelines. OPP also
continued to support OECD programs on integrated testing and assessment (IATA) and adverse
outcome pathways (AOP). Although the Office of Pesticide Programs coordinates the OECD Test
Guideline efforts, other EPA offices participate, as do representatives of the Food and Drug
Administration, Consumer Product Safety Commission, National Institute for Environmental
Health Sciences, and the US Army Corp of Engineers.
EPA provided international collaboration for review and comment on several documents in the
areas of human heath, ecotoxicity, antimicrobials and manufactured nanomaterials during FY' 18.
EPA input included the review of 21 new or revised test guidelines and guidance documents,
review of 15 new project proposals, review of 3 new Adverse Outcome Pathways and input to 3
surveys (e.g., Use of Systematic Literature Review for ED; Country-Specific Guidance or Other
Relevant Documents on OECD's Joint Integrated Approach to Testing and Assessment (IATA)).
Additionally, EPA nominated experts to participate in 6 newly formed OECD Test Guidelines
Programme Expert Groups (EGs) during 2018 (e.g.; EG on Pig-a Gene Mutation Assay;
Transgenic Rodent Assay Expert Group; EG for Guidance on Best Practices for Licensing of
Protected Elements in OECD TGs; Consolidate the EG on Biotransformation; EG on Defined
Approaches for Skin Sensitization; and EG for Developing a GD on Reporting of Metabolomics
Data) and OPP continued to lead the project on the development of the Performance Based Test
Guideline for Defined Approaches for Skin Sensitization.
Chemistry and Acute Toxicology Science Advisory Council (CATSAC). The Chemistry and
Acute Toxicology Science Advisory Council (CATSAC), which was formalized in 2016, plays an
important role in the implementation of the vision of the 2007 NAS report on toxicity testing in the
21st century  moving toward smarter testing strategies by waiving acute toxicity and product
chemistry studies that do not provide useful information for product registration. In 2018 the
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CATSAC continued to follow the newly finalized Standard Operating Procedure (2017) and worked
toward developing a Standard Evaluation Procedure (SEP) which will provide guidance on criteria
for substantially similar products and the potential for bridging data. The SEP will support
consistency in evaluations across OPP. In FY 2018, the CATSAC bridged the acute toxicity 6-pack
requirement 3 times, saving almost 400 animals and over $100,000 in study costs.
Ecological Risk Assessments
The EPA continued to develop and implement new scientific methods, tools, models, and
databases for use in pesticide ecological risk (including endangered species) and drinking water
assessments. Examples of these improvements are described in the sections below.
National Strategy to Improve Pollinator Health. In 2015, the White House issued the National
Strategy to Promote the Health of Honey Bees and other Pollinators that identified factors
associated with declines in honey bee (Apis mellifera) health and outlined efforts to address those
factors. OPP is continuing to collaborate with the Office of Research and Development (ORD) to
address uncertainties regarding exposure and effects of pesticides on honey bees and non-Apis
bees. In 2018, the ORD Strategic Research Action Plan identified pollinators as a priority
research area aimed at addressing needs identified in the Pollinator Research Action Plan
(PRAP), which is part of the National Strategy. Researchers the ORD National Health and
Environmental Effects Research Laboratory (NHERL) are collaborating with OPP's
Environmental Fate and Effects Division (EFED) technical staff and EPA Regional offices to
develop methods for testing the effects of pesticides on bumble bee (Bombus impatiens)
microcolonies. Also, consistent with recommendations from the 2012 FIFRA Scientific Advisory
Panel on assessing risks of pesticides to bees, OPP and ORD have also continued to collaborate
with researchers in the USD A Agricultural Research Service to further parameterize and validate
the USDA honey bee colony simulation model (VarroaPop). Once sufficiently vetted, the model
can be used to evaluate the potential effects of pesticides on honey bee colony performance and
potentially reduce the need for whole colony testing.
Also consistent with the Pollinator Partnership Action Plan of the National Strategy, EPA has
continued to engage with external stakeholder groups (e.g., Pollinator Partnership; Honey Bee
Health Coalition) and has contributed to the development of outreach materials to better inform
beekeepers and the agricultural community of challenges and means of addressing factors
affecting pollinator declines including best management practices for beekeepers and growers.
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Assessing Exposure and Effects of Pesticides. In December 2018, the proceedings of an EPA-
hosted workshop on assessing pesticide exposure to non-Apis bees and determining whether
honey bees are suitable surrogates for assessing exposure were published in the peer-reviewed
journal Environmental Toxicology. The international workshop and subsequent publication
underscored the utility of using honey bees as a surrogate when examining the primary routes of
exposure for honey bees, i.e., contact and ingestion of residues in pollen and nectar. The
publication identified areas where additional research is needed to determine whether current
methods for evaluating exposure are protective for non-Apis bees contacting/ingesting leaf
materials and/or mud used in constructing nests.
In 2018, OPP initiated a retrospective analysis of honey bee toxicity data from laboratory-based
studies. These analyses are responsive to National Academy of Sciences recommendations for
toxicity testing in the 21st Century toward reduced reliance on whole animal testing and will help
inform decisions on whether missing toxicity endpoints can be reliably/consistently extrapolated
for particular chemical classes based on existing data. The analyses are intended to also identify
possible situations where testing burden may be reduced and still support risk
assessment/characterization while reducing the level of resources needed to conduct and review
such studies.
In response to questions from the regulated community and the public, in 2018 OPP published to
the web responses to frequently asked questions (FAQs) surrounding the conduct and analysis of
both laboratory-based studies of individual bees and field-based exposure and effect studies on
honey bee colonies. The FAQs are intended to complement existing EPA and OECD test
guidelines and guidance documents and provide researchers with additional information on study
design elements toward increasing consistency and reliability of studies conduct to support
regulatory decisions.
Stakeholder Outreach. The EPA Pesticide Program also continued to reach out and to meet with
its state, federal, and global regulatory partners and its federal advisory committee (the Pesticide
Program Dialogue Committee), as well as other stakeholders, including beekeeping
organizations (American Beekeeping Association and the American Honey Producers
Association), pesticide registrants, academic researchers, industry, and environmental groups, on
pollinator protection efforts that focus on (1) advancing tools for risk assessment, (2) advancing
tools for risk management, and (3) communication and outreach. EPA staff also co-chaired
platform sessions and presented posters and symposium papers at conferences and scientific
meetings on pollinator issues this year.
In 2018, EPA worked with the PPDC to identify a means of evaluating voluntary state and tribal
Pollinator Protection Plans focusing on managed pollinators {i.e., MP3s) and/or native pollinators
{i.e., P3s). These plans are intended to foster/increase communication between relevant
stakeholders within states and Indian Lands to reduce potential exposure of bees to pesticides.
The PPDC recommended that EPA consider the offer by state lead agencies {i.e., the State FIFRA
Issues Research and Evaluation Group [SFIREG] and the American Association of Pest Control
Officers [AAPCO]) to develop a survey instrument to collectively evaluate the individualized,
state-specific approaches to pollinator protection. Tribal Nations are working with the Tribal
Pesticide Program Council (TPPC) to develop similar metrics for evaluating the native pollinator
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protection efforts; however, the tribes have the option of utilizing the MP3 survey instrument
developed by the state lead agencies. The MP3 survey will be administered annually beginning in
2019 and the results will serve as a line evidence with which EPA can determine the efficacy of
MP3 and P3 relative to reducing bee exposure of pesticides.
EPA is continuing to work collaboratively with the USDA on the guidance entitled Attractiveness
of Agricultural Crops to Pollinating Bees for the Collection of Nectar and/or Pollen. Consistent
with the process used since the USDA guidance was first released in 2015, both agencies have
continued to review petitions from various commodity groups to update the Guidance document
on the extent to which particular crops are attractive sources of pollen and/or nectar to honey bees
and non-Apis bees and to accurately reflect the extent to which and circumstances when a crop
may require managed pollination services.
EPA has continued to work in collaboration with USDA and researchers in academia and industry
in identifying new tools for controlling varroa mites, a serious pest of honey bees. In 2018, the
first year of a 3-yr grant from the Foundation for Food and Agriculture Research (a foundation of
the USDA), approximately 8 out of 24 chemicals tested for varroacidal activity under laboratory
conditions will be advanced to semi-field testing with honey bees.
OECD and International Pollinator Activities. EPA is continuing to work with its international
regulatory counterparts to develop appropriate assessment tools for evaluating the potential lethal
and sublethal effects of pesticides on managed and native pollinators using both laboratory and field-
based measures of exposure and effects. EPA has continued its efforts as a member of the
international OECD's Pesticide Effects on Insect Pollinators (PEIP) sub-group of the Pollinator
Expert Group. This sub-group was formed to develop portals for communicating information on
pollinator incidents and risk mitigation tools among OECD member countries. The sub-group also
reviews study designs for pollinator toxicity tests to determine if they can be enhanced or if new
tests are needed to better assess acute, chronic, and sub-lethal effects on pollinators and to develop
such guidelines. As part of that effort, in 2018 OPP science staff provided OECD comments on a
proposed test guideline for evaluating the acute toxicity of pesticides to the solitary non-Apis mason
bee (Osmia spp). This test design, if ratified, would provide a further means of evaluating the extent
to which non-Apis bees may be affected by exposure to pesticides when such higher-tier tests are
deemed necessary. This methodology compliments the standardized OECD test guidelines published
in 2017 for evaluating the effects of pesticides on social non-Apis bumble bees (Bombus spp)
EPA has continued to serve as a member of the Steering Committed for International Commission
for Plant-Pollinator Relationships (ICP-PR) Bee Protection Group which is helping to coordinate
international research efforts to advance testing methods for consideration by OECD. EPA staff
members are co-chairing subgroups tasked with identifying standardized testing methods for
conducting semi-field and full-field studies of conventional pesticides with honey bee colonies and for
identifying suitable test methods for evaluating microbial pesticides. International researchers within
the ICP-PR network have been largely responsible for developing the protocols for conducting
such tests and have participated in the ring testing used to verify the reproducibility and reliability
of these test methods. The collective efforts of these researchers will be presented at the 14th
International Symposium of the ICP-PR Bee Protection Group in Bern, Switzerland in October
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21st Century Methods and Reducing Animal Testing. Furthering the Agency's goal of
incorporating 21st century methods into risk assessment, EPA initiated a collaborative project
with the National Institute of Environmental Health Sciences to analyze warm water and cold-
water fish species acute toxicity data to guide testing requirements to reduce animal testing.
The goal of the effort is to determine if testing on fewer test species will allow the Agency to
sufficiently assess hazard to fish.
EPA has also collaborated with People for the Ethical Treatment of Animals (PETA) on a
project to determine if avian risks can be confidently and protectively assessed for most
chemicals using acute single oral dose study endpoints, thereby obviating the need for sub-
acute dietary studies in birds. PETA and EPA are collaborating on the publication of our
findings in the scientific literature, with publication expected in 2019. EPA also anticipates
developing a policy clarifying our avian toxicity data needs.
Aquatic Life Benchmarks for Pesticides. OPP's Aquatic Life Benchmarks for Pesticides
Registration webpage (
risks/aquatic-life-benchmarks-and-ecological-risk) currently includes entries for hundreds of
pesticide active ingredients and degradates. This is a collaborative effort between EPA and the
California Department of Pesticide Regulation and is responsive to requests from state lead
agencies for hazard information on pesticide active ingredients. Since 2015, EFED continues to
add new benchmarks or updates to existing benchmarks for active ingredients and
degradates/transformation products for which updated risk assessment or problem formulation
documents become publicly available. The FY' 18 aquatic life benchmarks report includes 615
chemicals, an increase of 6% from the FY' 17 report.
Greater Than Additive Effects. EPA developed an approach to considering information from
patent data suggesting synergistic effects, or greater than additive effects, in ecological risk
assessment, which ensures that the Agency is adhering to the National Academy of Science's
recommendation to consider pesticide interactions to the extent supported by scientific evidence
in regulatory decision making. EPA anticipates releasing that approach for public comment in
Endangered Species. In FY' 18, EPA, U.S. Fish and Wildlife Service (USFWS) and National
Marine Fisheries Service (NMFS), collectively referred to as the Services, continued to work
together to carry out the advice of the National Research Council (NRC) of the National
Academy of Sciences (NAS) for assessing the risks posed by pesticides to species listed as
endangered or threatened under the Endangered Species Act (ESA). In its 2013 report,
"Assessing Risks to Endangered and Threatened Species from Pesticides" the NAS considered
a range of scientific and technical questions related to determining the risks to listed species
covered under the Endangered Species Act (ESA) posed by pesticides considered for
registration under FIFRA.
EPA, the Services, and USD A had sought the NAS's advice regarding the approaches used by
EPA and the Services to assess the effects of proposed FIFRA actions on endangered species and
their habitats. Topics included best available scientific data, consideration of sub-lethal, indirect,
and cumulative effects, assessing the effects of pesticide mixtures and inert ingredients, the role
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and use of models, the use of geospatial information and datasets, and finally, uncertainty. The
report is available at: id 18344.
During FY' 18, EPA and the Services along with USD A continued to work together to further
refine shared interim scientific approaches that reflect NAS advice
(http://www.epa.gOv/sites/production/files/2015- 07/documents/interagencv.pdf) for assessing
the risks of pesticides to listed species. An interagency workshop was held to evaluate how usage
data can be incorporated into the consultation process. From that workshop, an interagency
workgroup met on a regular basis to develop methods to incorporate usage data into Step 1
(identify the action area) of the consultation process. EPA also presented updates on the
consultation process and the potential utility of usage data at scientific/technical conferences.
A final biological opinion (BiOp) was released in early FY' 18 from the National Marine
Fisheries Services (NMFS) on the first three pilot chemicals, chlorpyrifos, diazinon, and
malathion. EPA initiated consultation on these pesticides the prior fiscal year. EPA sought public
comments on the final BiOp and received approximately 125 substantive comments. An
additional approximately 19,000 comments were received as part of a signature campaign.
Additional refinements based on lessons learned from the first pilot BEs, including public input,
continue to be developed.
Also in FY' 18, EPA along with Department of the Interior and Department of Commerce signed
a memorandum of agreement creating a working group to provide recommendations for
improving the ESA consultation process for pesticide registration and registration review. They
are charged with reviewing statutory requirements, regulations and case, and making
recommendation to improve scientific and policy approaches.
Modeling - Use of Geospatial Tools. The EPA is developing updated scenarios for use in
aquatic exposure assessments for pesticides. Currently we model aquatic exposures with PRZM-
EXAMS, which uses scenarios to represent a combination of factors that are expected to
contribute to high-end pesticide concentrations in water. Although representative of vulnerable
areas where a pesticide may be used, these modeling scenarios do not identify the full extent of
specific geographic areas where off-site transport of a pesticide may pose a risk.
During FY' 18, EPA scientists initited an update to the modeling scenarios, and plans to get
public input in 2019.
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