Implementing the Pesticide Registration
Improvement Act - Fiscal Year 2013

Tenth Annual Report

March 1, 2014

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Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013

Process Improvements in the Pesticide Program

Science Review	ements

EPA's Office of Pesticide Programs (OPP) is engaged in a number of projects to advance our
strategic direction using "Integrated Approaches to Testing and Assessment" (IATA), which
promotes a hypothesis based, systematic, integrative use of exposure and hazard information.
Consistent with the 2007 report of the National Research Council (NRC) of the National
Academy of Sciences on "Toxicology Testing in the 21st Century", the goal of IATA is to refine,
reduce or even replace data requirements for complex laboratory animal studies while
maintaining the scientific defensibility of pesticide assessments.

In 2013 OPP provided staff the "Guiding Principles for Data Requirements" to enhance
consistency in the identification of data needs and to promote and optimize full use of existing
knowledge and focus on the critical data needed for risk assessment. We also developed policies
designed to reduce animal testing such as the "Part 158 Toxicology Data Requirements:
Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and
Immunotoxicity Studies" for guidance on using a weight-of-evidence evaluation to determine
data needs and the policies "Advances in Genetic Toxicology and Integration of in vivo Testing
into Standard Repeat Dose Studies" and "Alternate Testing Framework for Classifying Eye
Irritation Potential" for labeling antimicrobial pesticide products with cleaning claims under the
U.S. EPA classification and labeling system. To increase the availability of alternative testing
strategies, OPP played a major role in leading significant changes in leadership and strategic
direction of the Interagency Coordinating Committee on the Validation of Alternative Methods
(ICCVAM) (http://iccvam.niehs.nih.gov/announcements/ICCVAM-all/2013-02-Q6-EHP.htm).
In July 2013 OPP collaborated with stakeholders through the Pesticide Program Dialogue
Committee's (PPDC) 21st Century Toxicology/New Integrated Testing Strategies Workgroup to
hold a workshop entitled "Where Vision Meets Action: Practical Application of 21st Century
Methods" intended to provide an opportunity to dialogue with stakeholders on how OPP
envisions applying new science to change the way we evaluate the risks of pesticides, and to
examine the challenges and benefits of making this transition.

Ecological Risk Assessments

The agency continued to develop and implement new scientific methods, tools, models, and
databases for use in pesticide ecological risk and drinking water assessments. Examples of these
improvements include the following:

OECD Pollinator Activities. The EPA Pesticide Program is a member and co-chair of the
international Organization for Economic Cooperation and Development (OECD) Pesticide
Effects on Insect Pollinators (PEIP) sub-group of the Pollinator Expert Group. This sub-group
was formed to address four main goals: (1) develop a mechanism for efficiently communicating
accurate and necessary information on pollinator incidents among regulatory authorities of
member countries; (2) review 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; (3) develop a mechanism for sharing risk
management tools, including precautionary labeling, use restrictions, technologies, training

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materials, best management practices, and integrated pest management practices used by various
countries to mitigate pollinator risks and to recommend when and how tools should best be
applied and characterize their effectiveness; and (4) establish a communication "clearinghouse"
on research efforts to facilitate coordination and collaboration of research activities.

In 2013, the PEIP began developing portals for communicating pollinator incidents and sharing
risk mitigation tools. In addition, the subgroup updated the pollinator testing guideline inventory
and proposed priorities for future work related to testing and assessment needs.

In 2013, EPA staff participated in the OECD expert group meeting on larval honey bee toxicity
test designs. As a result of this effort, OECD issued a formal guideline (OECD 237) on single
dose toxicity testing with honey bee larvae in 2013. The OECD is currently considering a testing
guideline on repeat dose testing of larvae that extends the study through adult bee emergence.

EPA staff are also working with the International Committee for Plant Pollinator Relationships
(ICPPR) on possible standardized study designs for semi-field and full field pollinator toxicity
tests as well as methods for laboratory-based toxicity tests with bumble bees (Bombus terrestris).

More Pollinator Activities. The EPA Pesticide Program continued to reach out and to meet
with its state, federal, and global regulatory partners and advisory committees (the Pesticide
Program Dialogue Committee) as well as other stakeholders, including the 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, presented posters and symposium papers at conferences and scientific
meetings concerned with pollinator issues this year. OPP staff have also presented a series of
webinars to EPA regional offices and to stakeholder groups on agency pollinator protection
efforts.

In September 2012, the Pesticide Program, in collaboration with the Canadian Pest Management
Regulatory Agency (PMRA) and the California Department of Pesticide Regulation (CalDPR),
presented a proposed framework for quantifying the potential risks of pesticides to honeybees to
the FIFRA Scientific Advisory Panel (SAP). In response to comments received from the SAP,
we have worked with PMRA and CalDPR to finalize the guidance document for assessing risk to
bees. Consistent with our current pesticide risk assessment processes, the guidance describes a
multi-tiered approach that initially relies on laboratory-based studies on individual bees, and then
transitions to more realistic field-based studies involving whole colonies for chemicals that do
not pass the screening-level assessment. The process has served as a basis for data call-ins in
support of Registration Review and has been proposed for adoption by Mexico under the North
American Free Trade Agreement (NAFTA).

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In 2013, EPA in collaboration with USDA hosted a pollinator summit to discuss the multiple
ways in which stakeholders have been engaged in reducing potential exposure of pollinators to
dust generated through the abrasion of pesticide-treated seed during planting (dust-off). We have
been working closely with USDA and Health Canada's PMRA to encourage the development of
alternative lubricants to talc and graphite to reduce the potential for dust-off during planting.

OPP is working with EPA Region 5 and the EPA's Office of Research and Development (ORD)
through a Regionally-Administered Research Effort (RARE) grant to collaborate with USDA
and Health Canada's PMRA in examining factors associated with pollinator bee kill incidents in
the Midwest and to develop a simulation model for estimating the potential effects on honeybee
colonies from pesticides. This effort is consistent with recommendations from the FIFRA SAP
on the importance of developing tools such as simulation models for characterizing potential
risks from pesticides.

CETIS Implementation. In FY 2013, OPP implemented use of a new statistical program
known as CETIS (Comprehensive Environmental Toxicity Information System). The platform is
a Microsoft Access-based system, and functions as both a tool for statistical analysis as well as a
central repository for all data analyzed within. With this latter function as a database, future
plans are to conduct a meta-analysis, e.g. identify the most sensitive endpoint for a given taxa for
a given class of chemicals. The platform effectively replaces five different statistical programs
previously used by OPP scientists, some being outdated in terms of user interface and data entry,
others requiring a license available only to a few staff. As part of the CETIS implementation,
OPP conducted a thorough QC process, in which studies were analyzed using CETIS and older
statistical programs to ensure consistency in endpoint selection. In the past year that the
program has been implemented, OPP and its contractor have successfully transitioned to the
CETIS platform, which will allow greater flexibility to analyze additional guideline studies in the
future, such as pollinator toxicity studies.

OPP/OW Harmonization of Aquatic Life Assessments. OPP and EPA's Office of Water
(OW), with support from the Office of Research and Development (ORD), presented a Common
Effects Methodology showing possible methods to harmonize the analysis and characterization
of aquatic ecotoxicity data, to the (SAP) on January 31 through February 2, 2012. The methods
and subsequent analysis included examples of approaches that could be used to leverage OPP
data to meet OW's minimum data requirements for Aquatic Life Criteria derivation. In the SAP
meeting, the EPA evaluated several possible approaches for analyzing available data to estimate
effects on aquatic organisms.

Feedback from this external peer review is a key step in establishing new approaches and
methods. The SAP issued a written response to these analyses on April 30, 2012. In general, the
SAP report provided positive feedback on the analysis and made recommendations for future
efforts. OPP, OW and ORD have identified short term and long term research efforts to advance

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and achieve the EPA's goal of improved harmonization between OPP and OW in the
characterization of aquatic effects (toxicity) of pesticides. OPP and OW are currently piloting an
interim approach to develop community-level benchmarks that relies on the existing Tier II
method that utilizes extrapolation factors developed under the Great Lakes Initiative (GLI).

These community-level benchmarks will conservatively approximate an Aquatic Life Criteria
(ALC) value and will initially be piloted for a few pesticides.

Drift Reduction Technologies. In FY 2013, the Pesticide Program continued to work on
developing the Drift Reduction Technology (DRT) Program. The purpose of this voluntary
program is to encourage the identification and use of spray application technologies capable of
significantly reducing pesticide spray drift. Under ORD's Environmental and Sustainable
Technology Evaluation program, OPP and ORD, with input from external experts, developed a
draft verification protocol and guidance document. The DRT testing protocol was adapted from
standard test methods and regulatory methods used in the U.S. and other countries, and it
describes the testing approach that will be used to generate high-quality, peer-reviewed data for
DRTs. The protocol also describes the test design and quality assurance aspects. On November
21, 2012, EPA published a Notice in the Federal Register announcing this proposed information
collection activity and providing a 60-day public comment period. That Notice as well as the
support documents (draft DRT testing protocol and descriptions of the program) and the
comments submitted are available at regulations.gov using the docket identifier EPA-HQ-OPP-
2012-0631. The agency revised the draft protocol and guidance document based on the
comments. In early 2014, EPA plans to publish another Federal Register Notice that the revised
documents will be submitted to OMB. The focus of this test protocol is for technologies used for
ground boom and aerial applications to row and field crops. Additional information is available
at: http://www.epa.gov/oppfeadl/cb/csb page updatcs/2012 drift-rcduction.html.

Endangered Species. In April of 2013, the National Research Council (NRC) of the National
Academy of Sciences (NAS) released a report entitled, "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 under the Endangered Species Act
(ESA) posed by pesticides considered for registration under FIFRA in a report entitled,. The
EPA, USDA and the Departments of Commerce and Interior sought the NAS's advice regarding
the approaches used by the EPA, the Fish and Wildlife Service (FWS), and the National Marine
Fisheries Service (NMFS) 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 and use of models, the use of geospatial information and datasets and finally
uncertainty. The report is available at: http://www.nap.edu/catalog.php7record id 18344.

Since receiving the NAS report, the four agencies have been working together to collectively
develop shared scientific approaches that reflect the advice provided by NAS and have
developed interim scientific approaches for assessing the risks of pesticides to listed species.
The interim approaches for the pesticide ESA consultation process, which are based on shared

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assumptions, data, analytical processes and models, will be applied collaboratively as part of
EPA's Registration Review program beginning in 2014.

ESA Knowledge Base. EPA's current ecological risk assessments for pesticides consider
potential impacts of pesticides on broad taxa (e.g., freshwater fish, terrestrial plants, birds). For
terrestrial animals, including mammals, birds, reptiles and terrestrial-phase amphibians, generic
body weights and diets are used to estimate pesticide exposures and subsequent risks. The most
conservative exposure estimates from these generic animals are currently used to assess risks to
federally listed endangered and threatened species (referred to as "listed species"). In order to
consider species-specific body weights and diets that result in more representative, less
conservative estimates of pesticide exposure and risk, the EPA has compiled data on all currently
listed species of mammals, birds, reptiles and amphibians. We obtained these data from USFWS
and NMFS documentation describing species (e.g., recovery plans, critical habitat descriptions)
as well as published scientific literature. We have entered species specific parameters into our
current exposure models (T-REX and KABAM) to allow our scientists to calculate risk quotients
for individual listed species of mammals, birds, reptiles and amphibians. We have also collected
other data, such as obligate relationships, habitat descriptions, and elevation restrictions, all of
which may be used in species-specific effects determinations for pesticides that may be used on a
national scale. All data are captured in a series of reports that include the source information as
well as justification for model parameterization. In addition, species specific information are
being captured in a database that is designed to house biological and geographic data on all listed
species (including terrestrial animals as well as aquatic animals and plants). This database will
allow users to search for species based on their characteristics.

In 2013, data entry was completed for all listed terrestrial birds, mammals, amphibians, and
reptiles following a strict and formal review process. Additional information including
identification of federal lands with listed species and primary constituent elements associated
with designated critical habitat was also gathered. A number of database functions were added
or enhanced in 2013 including searching and reporting functionalities in addition to document
storage capabilities. Reports were completed that summarize biological data necessary for
making pesticide effects determinations for listed mammals, birds, reptiles, and amphibians.
Biological characteristics necessary for making pesticide effects determinations were identified
for listed plants and aquatic organisms as well. Data collection has begun for listed plant species
and will soon begin for listed aquatic species.

Modeling - Use of Geospatial Tools. The EPA is developing a Spatial Aquatic Model (SAM)
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

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vulnerable areas where a pesticide may be used, these modeling scenarios do not identify
specific geographic areas where off site transport of a pesticide may pose a risk. With the
increased demand for a spatial context to both human health (drinking water) and ecological
(endangered species) aquatic exposure assessments, we need a way to add a spatial context to
aquatic exposure in an efficient, consistent way without increasing the workload for the risk
assessor.

In 2013 we succeeded in running a pilot version of SAM for the Ohio River basin, simulating
water flow and pesticide concentrations over a range of water body sizes for both reservoirs and
streams/rivers. Model results are being compared with USGS streamgage stations (for
hydrology) and intensive pesticide monitoring data in order to improve the model components.
Based on the pilot results, a remote server, cloud, or similar options for data storage, analysis,
and model processing will be necessary to run the model on a national scale. Model users would
connect with SAM remotely from their desktops. We plan to engage end users, risk managers,
and other interested parties as we develop and implement SAM for national scale modeling.

Modeling - PRZM-GW. EPA scientists have been using SCI-GROW (Screening Concentration
in Groundwater) as a screening-level tool to estimate drinking water exposure concentrations
from groundwater resulting from pesticide use (Barrett, 1997). SCI-GROW is strictly a
screening-level exposure tool and does not have the capability to consider mitigating
circumstances such as variability in leaching potential of different soils, weather (including
rainfall), cumulative yearly applications or depth to aquifer. If SCI-GROW-based assessment
results indicate that pesticide concentrations in drinking water exceed the level of risk concern,
the ability to refine the assessment is limited. In 2004, we initiated evaluation of advanced
methods for estimating pesticide concentrations in groundwater as part of the cumulative risk
assessment of carbamate pesticides. Similarly in 2004, Health Canada's Pest Management
Regulatory Agency (PMRA) published information outlining an initial direction on use of
modeling to estimate pesticides in groundwater. Because groundwater resources in Canada and
the United States are similar and many modeling aspects and needs are the same, the two
organizations combined efforts as part of the North American Free Trade Agreement (NAFTA)
to develop a harmonized groundwater modeling protocol. The NAFTA team developed and
harmonized the groundwater conceptual model with input from the FIFRA Scientific Advisory
Panel. The NAFTA project was finalized in 2013. Concurrently we are phasing in
implementation of PRZM-GW. During 2013, PRZM-GW and SCI-GROW results were
compiled. This information will be evaluated as part of the final implementation of PRZM-GW,
and the results will be reported at an Exposure Modeling Public Meeting in 2014.
Implementation of PRZM-GW in OPP's assessment methodology increases our ability to refine
assessments and tailor risk mitigation decisions to various geographic conditions across the
country, supporting the agency's mission by ensuring the safe use of pesticides and protecting
human health.

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Human Health Risk Assessments

Science Review Committees. 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 fiscal year 2013, the ROCKS held four meetings on
four chemicals. The Dose Adequacy Review Team (DART) reviewed study protocols submitted
by various registrants for 4 chemicals. The Cancer Assessment Review Committee (CARC) met
ten times on numerous chemicals, and the Toxicology Science Advisory Council (ToxSAC) met
28 times to discuss and determine end-points of concern. The Risk Assessment Review
Committee (RARC) met nineteen times to peer review risk assessments that will undergo public
comment.

Integrated Approaches to Testing and Assessment. Agency scientists continue to participate
in the NAFTA Joint Integrated Approach to Testing and Assessment (IATA) Projects on
computational tools such as Quantitative Structure-Activity Relationship models ((Q)SAR) and
MetaPath. Included in this NAFTA project is the development of a guidance document for use
of (Q)SAR in pesticide risk assessments. This is an on-going project that includes collaboration
between the EPA, Canada's Pest Management Regulatory Agency (PMRA), and the Food and
Drug Administration (FDA). Efforts continued within the Organization for Economic and
Cooperative Development (OECD) MetaPath Users Group (MUG) to further explore
opportunities to use MetaPath in global pesticide risk assessments and to continue its database
development, along with the customization of the MetaPath DER Composer. The Pesticide
Program is using the composer for rat and livestock metabolism studies. Current international
collaborators include: Health Canada, PMRA, the European Food Safety Authority (EFSA), the
Australian Pesticides and Veterinary Medicines Authority (APVMA), France, and Germany. In
addition, the OECD initiated a project on Adverse Outcome Pathways (AOP), a conceptual
framework designed to portray causal and predictive linkages between molecular-cellular
disruption (initiation of a toxicity or disease pathway) and adverse outcomes of regulatory
significance in individuals or populations.

International Collaboration for 21st Century Toxicology and Exposure Assessment.

Consistent with National Academy of Sciences reviews, and in collaboration with national and
international bodies, the agency worked to develop and implement 21st Century toxicology and
exposure methods, including computer-modeling and in vitro techniques, to advance more
efficient and effective risk assessments that support sound, risk-based regulatory decision-
making. In 2013, advancements were made in the completion of guiding principles for data
requirements; waiver guidance for inhalation, dermal, neurotoxicity, and immunotoxicity studies;
and in alternative testing for skin irritation (See

http://www.epa.gov/pesticides/science/guidelines.htm). The international community has made
great strides towards developing an integrated testing strategy for skin sensitization based on the
adverse outcome pathway that does not involve whole animal testing

(http://www.oecd.Org/env/ehs/testing/listsofproiectsontheaopdevelopmentprogrammeworkplan.h
tm). In 2014, we will be working with OECD, WHO, and ICCVAM to continue progress on

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such an integrated testing strategy for skin sensitization. In 2013, we initiated a collaborative
project with NIEHS-NICEATM to evaluate oral and dermal acute lethality studies to consider
the potential for waiving such dermal studies to reduce the use of animals and to improve
efficiency in labeling. In addition, we have improved the integration of in vitro and in vivo
experimental toxicology and human information by applying the adverse outcome pathway
concept as the unifying concept for evaluating the strengths and limitations of data across
different levels of biological organization. An example of the implementation of 21st century
approaches is a large scale research effort by a group of pyrethroid registrants to evaluate
potential for juvenile sensitivity to pyrethroids. This research involves a combination of multiple
in vitro assays, computational approaches, and sophisticated pharmacokinetic and population-
based modeling. These data and models are expected to become available for review in FY2014
and will be used directly for the pyrethroid risk assessment. However, the overall approach and
associated lessons learned can be used as a foundation for similar 21st century approaches for
more classes of chemicals.

Hazard and Science Policy Committee (HASPOC). As the central forum to address science,
policy, hazard data waivers, and risk deliberation and coordination issues of central importance
to OPP, the HASPOC was very active this year. HASPOC plays an important role in the
implementation of the vision of the 2007 NAS report on toxicity testing in the 21st century —
moving towards smarter testing strategies by waiving toxicity studies that do not provide useful
information. In 2013, HASPOC reviewed data waivers for a variety of toxicity studies, primarily
for the immunotoxicity, acute and subchronic neurotoxicity, and subchronic inhalation toxicity
studies. Waivers were granted for 232 of 322 requests resulting in the saving of over 15,000
animals and over $20 million in the cost of conducting the studies.

Crop Grouping Work. The EPA and PMRA approved two tropical fruit groups with over 250
commodities. In addition, work continues with the American Herbal Association, the American
Spice Trade Association and other groups on updating the Herb and Spice crop group in 2014.
This update is expected to greatly expand the number of herbs and spices that are included in this
crop group and facilitate international harmonization and trade for these important products.

Dietary Exposure Assessment. The EPA released an updated version of the Dietary Exposure
Evaluation Model-Food Commodity Intake Database (DEEM-FCID)/Calendex software, which
replaces the previous version posted on the EPA website, in June 2012. The DEEM-FCID
software can be found and downloaded at: http://www.epa.gov/pesticides/science/deem/.

As an additional move to increase the transparency and public availability of dietary exposure
software, the data used by DEEM were made available on the website of the University of
Maryland's Joint Institute of Food Safety and Nutrition (JIFSAN) at http://fcid.foodrisk.org.

With the release of the updated version of DEEM-FCID/Calendex software, the JIFSAN website
also makes available the 2003-2008 FCID raw data files that were incorporated into DEEM-
FCID/Calendex. In addition, JIFSAN developed and posted several online applications to
facilitate public access to and interpretation of information from the raw data, including a
consumption calculator that considerably simplifies the use of the data for routine food and food
commodity consumption queries. A FAQ list describes the data and information available on the

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JIFSAN foodrisk.org website as well as the history of, sources for, and background behind the
EPA's development of FCID for dietary exposure assessments. Efforts to make these files more
publically available, transparent, and considerably easier to use were funded by the U.S.
Department of Agriculture and the U.S. Food and Drug Administration.

Updated Transfer Coefficient (TC) Policy. We updated the policy that provides a systematic
basis for evaluating the risks associated with hand labor activities for all major commercial
crops. It also identifies activities that do not require assessments because their exposure potential
is deemed to be negligible (e.g., operation of a mechanical combine for grain harvest). This
guidance represents the culmination of a 25-year effort that a 1992 Data Call-In, guideline
development, collaboration with the Agricultural Re-Entry Task Force (ARTF) and other
regulatory agencies (e.g., Cal-DPR and PMRA), and a consultation with the FIFRA Scientific
Advisory Panel.

Revised Residential SOPs. The Revised Residential SOPs were first released in January 2012
and billed as a "living document" subject to revision based on new or more contemporary
information. In early FY' 13, we released the second update to include revisions to the outdoor
fogger and insect repellent SOPs. In addition, it included new versions of the SOP spreadsheet
calculators. All of these changes were the result of close work with stakeholders to ensure the
SOPs stay up-to-date and reflect the current state of the science.

Updated Unit Exposure (UE) Surrogate Table. Continuing a multi-year effort, OPP updated
elements of the unit exposure surrogate table, a quick reference guide that presents the current
recommended unit exposures for standard agency occupational pesticide handler exposure
scenarios. This surrogate reference table continues to be updated as additional pertinent
exposure data become available including data from the Pesticide Handler Exposure Database
(PHED), the Outdoor Residential Exposure Task Force (ORE I F), the Agricultural Handler
Exposure Task Force (AHE I F), 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.

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.
Although the Office of Pesticide Programs coordinates the OECD Test Guideline efforts, several
EPA offices participate, as well as representatives of the Food and Drug Administration,

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Consumer Product Safety Commission, National Institute for Environmental Health Sciences,
and the US Army.

Global Review Work. OPP continued to lead in collaboration on global joint review activities
for new conventional pesticides. In addition to tackling a larger portion of the primary reviews
for several large submissions, OPP prepared documents to support the international residues of
concern discussion through the agency's Residues of Concern Knowledge-Based Subcommittee
(ROCKS) of the RARC. For each of the global reviews, we shared documentation and proposed
decisions with international partners and considered their perspectives in preparing the final
decision. Without this leadership, decisions would have to be made by individual teams on a
per-chemical basis. In addition to the ROCKs committee, international partners were invited to
participate in numerous peer review committees, including ChemSAC, ToxSAC, RARC, and
CARC. The agency has taken a leadership role by providing draft documents for review,
ultimately resulting in better support for proposed decisions, including buy-in from global
partners.

Global Harmonization Work. OPP worked closely with the OECD's Residue Expert Working
Group (REWG) and others on issues associated with translation of field trial data across
application rates to estimate internationally harmonized MRLs. Issues associated with adjusting
field trial residues by application rate were resolved in the REWG and forwarded to, discussed
in, and agreed to in principle by Codex. The work does "double-duty" in that it completes one
component of the joint US-Canada Regulatory Cooperation Counsel (RCC) agreements. The
advancement of this "proportionality principle" completes an effort that was originally conceived
more than a decade ago and is expected to result in broader international acceptance of field
trials. It is designed to complement an effort beginning in earnest in 2014 that will attempt to
evaluate the importance of global zones in determining pesticide residues and the extent to which
field trials can be exchanged among regions.

Human Health Benchmarks for Pesticides (HHBPs). We updated the HHBPs in water to
include cancer quantification values for 40 chemicals and to add non-cancer values for 11 new
chemicals and revisions for 11 existing chemicals. HHBPs can be found on the EPA's website at
www.epa.gov/pesticides/hhbp. The HHBPs were developed jointly by OPP and OW under
Administrator Jackson's new drinking water strategy and will be used to assist states, the public
and other stakeholders to determine whether the detection of a pesticide in drinking water or
source waters for drinking water may indicate a potential health risk. The water benchmarks
were derived using peer reviewed Reference Dose values from OPP's human health risk
assessments along with typical methods used to develop OW's drinking water health advisories.
Stakeholders can use HHBPs when evaluating the significance of detections of pesticides in both
surface water and groundwater sources of drinking water.

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