Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Imidacloprid
Proposed Interim Registration Review Decision
Case Number 7605
January 2020
Approved by:
Elissa Reaves, Ph.D.
Acting Director
Pesticide Re-evaluation Division
Date: 1-22-2020
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Table of Contents
I. INTRODUCTION 4
A. Summary of Imidacloprid Registration Review 5
B. Summary of Public Comments on the Draft Risk Assessments and Agency Responses 7
II. USE AND US AGE 14
III. SCIENTIFIC ASSESSMENTS 15
A. Human Health Risks 15
1. Risk Summary and Characterization 15
2. Human Incidents and Epidemiology 17
3. Tolerances 18
4. Human Health Data Needs 18
B. Ecological Risks 18
5. Risk Summary and Characterization 19
6. Ecological Incidents 30
7. Ecological and Environmental Fate Data Needs 32
C. Benefits Assessment 32
IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION 39
A. Proposed Risk Mitigation and Regulatory Rationale 39
1. Cancellation of Uses 41
2. Prohibition of On-farm Seed Treatment for Canola, Millet, and Wheat 41
3. Personal Protection Equipment 41
4. Application Rate Reductions 42
5. Crop Stage Restrictions 48
6. Residential Ornamental Advisory 50
7. Label Language Improvements 50
8. Restrictions to Poultry House Uses 50
9. Spray Drift and Runoff Reduction 51
10. Pesticide Resistance Management 56
B. Stewardship 57
C. Tolerance Actions 58
D. Proposed Interim Registration Review Decision 58
E. Data Requirements 59
V. NEXT STEPS AND TIMELINE 59
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A. Proposed Interim Registration Review Decision
B. Implementation of Mitigation Measures
Appendix A: Summary of Proposed Actions for Imidacloprid
Appendix B: Proposed Labeling Changes for Imidacloprid Products
Appendix C: Endangered Species Assessment
Appendix D: Endocrine Disruptor Screening Program
Appendix E: Summary of Proposed Tolerance Actions
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I. INTRODUCTION
This document is the Environmental Protection Agency's (EPA or the agency) Proposed Interim
Registration Review Decision (PID) for imidacloprid (PC Code 129099) and is being issued
pursuant to 40 CFR §§ 155.56 and 155.58. A registration review decision is the agency's
determination whether a pesticide continues to meet, or does not meet, the standard for
registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency may
issue, when it determines it to be appropriate, an interim registration review decision before
completing a registration review. Among other things, the interim registration review decision
may require new risk mitigation measures, impose interim risk mitigation measures, identify data
or information required to complete the review, and include schedules for submitting the
required data, conducting the new risk assessment and completing the registration review.
Additional information on imidacloprid, can be found in the EPA's public docket (EPA-HQ-
OPP-2008-0844) at www.reeutations.gov.
FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the
continuous review of existing pesticides. All pesticides distributed or sold in the United States
must be registered by the EPA based on scientific data showing that they will not cause
unreasonable risks to human health or to the environment when used as directed on product
labeling. The registration review program is intended to make sure that, as the ability to assess
and reduce risk evolves and as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects. Changes in science, public
policy, and pesticide use practices will occur over time. Through the registration review
program, the agency periodically re-evaluates pesticides to make sure that as these changes
occur, products in the marketplace can continue to be used safely. Information on this program is
provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the agency implemented the
registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide
every 15 years to determine whether it continues to meet the FIFRA standard for registration.
The EPA is issuing a PID for imidacloprid so that it can (1) move forward with aspects of the
registration review that are complete and (2) implement interim risk mitigation (see Appendices
A and B). The agency is currently working with the U.S. Fish and Wildlife Service and the
National Marine Fisheries Service (together, the Services) to develop methodologies for
conducting national threatened and endangered (listed) species assessments for pesticides in
accordance with the Endangered Species Act (ESA) § 7. Therefore, although the EPA has not yet
fully evaluated risks to listed species, the agency will complete its listed species assessment and
any necessary consultation with the Services for imidacloprid prior to completing the
imidacloprid registration review. Likewise, the agency will complete endocrine screening for
imidacloprid, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), before
completing registration review. See Appendices C and D, respectively, for additional information
on the endangered species assessment and the endocrine screening for the imidacloprid
registration review.
Imidacloprid is an N-nitroguanidine neonicotinoid insecticide, which causes irreversible
blockage of the postsynaptic nicotinic acetylcholine receptors. It is a xylem and phloem-mobile
systemic compound that is readily taken up by the roots of the plants and translocated through
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the plant via transpiration. There are over five hundred FIFRA § 3 and § 24(c) (Special Local
Needs) products containing imidacloprid registered in the United States. Products containing
imidacloprid can be formulated as granules, ready-to-use solutions, emulsifiable concentrates,
flowable concentrates, water soluble packages (WSP), dust, impregnated materials, etc. Products
can be applied via liquid spray of drench, broadcast granules, baits, and as seed treatment.
Imidacloprid products can be applied to a variety of agricultural crops, including but not limited
to, root and tuber vegetables, fruiting vegetables, oilseed crops, citrus fruit, leafy green
vegetables, cucurbit vegetables and tropical and subtropical fruits. Imidacloprid products are also
registered on non-agricultural use sites including but not limited to, turf and ornamentals,
forestry, Christmas tree plantations, pet spot-on and collar products, baits and pellets, and in
farm/residential/commercial areas. The first imidacloprid product was registered for use in 1994,
and as a result, imidacloprid was not reviewed under the reregi strati on process.
This document is organized in five sections: the Introduction, which includes this summary and a
summary of public comments and the EPA's responses; Use and Usage, which describes how
and why imidacloprid is used and summarizes data on its use; Scientific Assessments, which
summarizes the EPA's risks, and updates or revisions to previous risk assessments, and provides
broader context with a discussion of risk characterization; Benefits Assessments, which describes
the utility of the chemical along with any potential impacts of mitigation; the Proposed Interim
Registration Review Decision, which describes the mitigation measures proposed to address risks
of concern and the regulatory rationale for the EPA's PID; and, lastly, the Next Steps and
Timeline for completion of this registration review.
While this PID focuses on the specific risks, benefits, and mitigation measures for imidacloprid,
the EPA is issuing PIDs for all of the currently registered N-nitroguanidine neonicotinoid
pesticides concurrently to ensure consistency across the class. The PIDs and supporting
documents for clothianidin, dinotefuran, and thiamethoxam are available in the public dockets
established for each of these cases.
A. Summary of Imidacloprid Registration Review
Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for imidacloprid
with the opening of the registration review docket for the case. The following summary
highlights the docket opening and other significant milestones that have occurred thus far during
the registration review of imidacloprid.
• December 2008 - The imidacloprid Summary Document, Human Health Scoping
Document, and Environmental Fate and Effects Problem Formulation were posted to the
docket for a 60-day public comment period.
• June 2009 - The Final Work Plan (FWP) for Imidacloprid was issued. During the
comment period the agency received one comment concerning trade irritants. The Final
Work Plan was amended in July 2010 to include additional data necessary to support the
registration review of imidacloprid.
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• November 2010 - A Generic Data Call-In (GDCI) for imidacloprid was issued for data
needed to conduct the registration review risk assessments; all data requirements have
been satisfied.
• January 2016 - The agency announced the availability of the Preliminary Pollinator
Assessment to Support the Registration Review of Imidacloprid for a 60-day public
comment period which was then extended 30-days.
• January 2017 - The agency announced the availability of the Preliminary Aquatic Risk
Assessment to Support the Registration Review of Imidacloprid for a 60-day public
comment period.
• September 2017 - The agency announced the availability of the Imidacloprid: Human
Health Draft Risk Assessment for Registration Review, Imidacloprid. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the
Registration Review Risk Assessment., and Imidacloprid. Occupational and Residential
Exposure Assessment for Registration Review, for a 60-day public comment period.
• December 2017 - The agency announced the availability of the following documents to
support Registration Review for a 60-day public comment period which was then
extended for an additional 60 days to April 21, 2018:
o Biological and Economic Analysis Division (BEAD) Response to Public
Comments Submitted in Response to BEAD's Assessment entitled "Benefits of
Neonicotinoid Seed Treatments to Soybean Production " Dated October 15, 2014,
OPPDocket: EPA-HQ-OPP-2014-0737, December 5, 2017
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Cotton, December 5, 2017
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Citrus, November 21, 2017
o Imidacloprid Transmittal of the Preliminary Terrestrial Risk Assessment to
Support Registration Review, November 28, 2017
• January 2020 - The agency is now announcing the availability of the PID in the docket
for imidacloprid, for a 60-day public comment period. Along with the PID, the following
documents are also posted to the imidacloprid docket:
o Benefits of Neonicotinoid Insecticide Use in Cucurbit Production and Impacts of
Potential Risk Mitigation, December 11, 2019
o Benefits of Neonicotinoid Insecticide Usage in Grapes and Impacts of Potential
Mitigation, October 23, 2019
o Benefits and Impacts of Potential Mitigation for Neonicotinoid Seed Treatments
on Small Grains, Vegetables, and Sugarbeet Crops, August 30, 2018
o Usage, Pest Management Benefits, and Possible Impacts of the Potential
Mitigation of the Use of the Four Nitroguanidine Neonicotinoids in Pome Fruits
(Apple, Pear), December 11, 2019
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o Assessment of Usage, Benefits and Impacts of Potential Mitigation in Stone Fruit
Production for Four Nitroguanidine Neonicotinoid Insecticides (Clothianidin,
Dinotefuran, Imidacloprid, and '/hiamethoxam), December 6, 2019
o Usage and Benefits of Neonicotinoid Insecticides in Rice and Response to
Comments, April 22, 2019
o Benefits of Neonicotinoid Insecticide Use in Berries (Strawberry, Caneberry,
Cranberry, and Blueberry) and Impacts of Potential Mitigation, December 6,
2019
o Benefits of Neonicotinoid Insecticide Use and Impacts of Potential Risk
Mitigation in Vegetables, Legumes, Tree Nuts, Herbs, and Tropical and
Subtropical Fruit. December 20, 2019
o Review of "The Value of Neonicotinoids in North American Agriculture "
prepared by Aglnfomatics, LLC for Bayer CropScience, Mitsui, Syngenta, and
Valent, November 4, 2019
o Review of "The Value of Neonicotinoids in Turf and Ornamentals" prepared by
Aglnfomatics, LLC for Bayer CropScience, Mitsui, Syngenta, and Valent,
December 11, 2019
o Comparative analysis of Aquatic Invertebrate Risk Quotients generatedfor
neonicotinoids using Raby et al. (2018) toxicity data, January 7, 2020
o Flumethrin: Tier I Update Review of Human Incidents and Epidemiology for
Proposed Interim Decision1, September 17, 2019
o Imidacloprid. Updated Residential Exposure Assessment in Response to Draft
Risk Assessment (DRA) Comments., February 11, 2019
o Imidacloprid. Updated Non-Occupational Spray Drift Exposure Assessment in
Response to Draft Risk Assessment (DRA) Comments, January 10, 2020
o Final Bee Risk Assessment to Support the Registration Review of Imidacloprid,
January 14, 2020
o Note to Reader: Documents Supporting the Registration Review of Imidacloprid
The agency will be posting a reader's guide in the docket to assist with navigation of the
imidacloprid supporting documents.
B. Summary of Public Comments on the Draft Risk Assessments and Agency
Responses
Two separate comment periods were held for imidacloprid risk assessment documents. The
Preliminary Pollinator Assessment to Support the Registration Review of Imidacloprid was
published January 4, 2016 for for an initial 60-day public comment period. The comment period
for the draft human health and non-pollinator ecological risk assessments for imidacloprid, as
well as various supporting benefits-related registration review documents, opened on December
21, 2017 for an initial 60-day public comment period.
1 Flumethrin updated human incident assessment composed of only incidents related to the combined imidacloprid
and flumethrin product.
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Across these comment periods, the agency received a total of 1,433 unique/distinct public
comments to the imidacloprid docket. In addition, the neonicotinoids received approximately
400,000 mass mail campaign submissions. Comments were submitted by various individuals,
organizations, and companies. Comments of a broader regulatory nature, and the agency's
responses to those comments, are provided in the memorandum Response from the Pesticide Re-
evaluation Division to Comments on the Draft Risk Assessments and Benefits Assessments
Supporting the Registration Review of the Nitroguanidine-substituted Neonicotinoid Insecticides.
Comments on the topics of neonicotinoid benefits, ecological effects and human health effects
are noted and responded to in the following memoranda:
• Biological and Economic Analysis Division's (BEAD) Response to Comments on the
Preliminary Risk Assessments and Benefit Assessments for Citrus, Cotton, Soybean Seed
Treatment, and Other Crops Not Assessedfor Neonicotinoid Insecticides. December 23,
2019.
• EFED Response to Public Comments Common to the Preliminary Pollinator and
Preliminary Non-Pollinator Registration Review Risk Assessments Across the Four
Neonicotinoid Pesticides (Imidacloprid, Thiamethoxam, Clothianidin, and Dinotefuran),
January 6, 2020
• Imidacloprid: Response to Public Comments Related to the Preliminary Risk Assessments
and Addendum to the Non-Pollinator Risk Assessments in Support of Registration Review
(Docket No. EPA-HQ-OPP-2008-0844), January 8, 2020
• Imidacloprid: Draft Human Health Risk Assessment (DRA) for Registration Review -
Response to Comments, November 12, 2019
Additionally, the agency received comments to the preliminary risk assessments that resulted in
revised risk assessments and/or adjustments to EPA's risk management approach. These
comments are captured below, along with the agency's responses to those comments. The
agency thanks all commenters for their comments.
Comment Submitted by Bayer Healthcare, LLC, in EPA-HQ-QPP-2008-0844-1247
Comment: In response to EPA's identification of data gaps in the TTR and dermal absorption
studies used in the imidacloprid human health risk assessment, Bayer CropScience (BCS)
submitted the results of an imidacloprid-specific TTR study and a formulation-specific in vivo
dermal absorption study to refine the EPA's imidacloprid human health risk assessment.
EPA Response: The agency thanks BCS for its comment and study submissions. The agency
reviewed these studies and determined that the TTR and dermal absorption data deficiencies are
now satisfied and that the dermal absorption factor (DAF) can be reduced from 7.2% to 4.8%.
The agency refined the residential handler and post-application risk estimates using these studies
and determined that there are no residential handler or post-application risks of concern
associated with the pet collar use. EPA also identified with the newly available data new
potential risks of concern associated with use on turf in non-irrigated plots, however, there are no
remaining residential post-application exposure risks of concern associated with use on turf in
irrigated plots. For a more detailed description of the updated risk estimates, please refer to
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Imidacloprid. Updated Residential Exposure Assessment in Response to Draft Risk Assessment
(DRA) Comments, available in the public docket.
Comment Submitted by the Massachusetts Office of the Attorney General (EPA-HQ-OPP-
2011-0920-0725):
Comment: The Massachusetts Office of the Attorney General (MA-OAG) expressed concerns
regarding risks to pollinators from residential homeowner applications of neonicotinoids on
gardens, lawns and ornamentals. MA-OAG also highlighted that many retailers have voluntarily
committed to phasing out the sale of plants and other products containing neonicotinoid
insecticides. MA-OAG suggests that the agency severely curtail the use of neonicotinoids.
EPA Response: EPA thanks the Massachusetts Office of the Attorney General for its comment.
The agency recognizes the potential risks to pollinators from homeowner applications of
neonicotinoids on gardens, lawns, and ornamentals. In response, the agency is proposing certain
rate reductions and require advisory label language for residential ornamental labels stating,
"Intended for use by professional applicators". Please refer to Section IV. A of this PID for
additional details regarding the proposed label changes.
Comment Submitted by the National Association of State Departments of Agriculture
(EPA-HO-QPP-2008-0844-1043):
Comment: The National Association of State Departments of Agriculture (NASD A) encourages
the agency to fully articulate risk mitigation measures with state lead agencies, registrants,
producers, users, and the agricultural stakeholder community to facilitate an informed risk
assessment. Furthermore, NASDA is concerned that the agency did not articulate the benefits in
the Preliminary Pollinator Assessment to Support the Registration Review of Imidacloprid.
EPA Response: The agency continues to encourage public/stakeholder participation through the
public comment period. Moreover, the agency prepared refined risk assessments in response to
substantive comments, and also provided several additional benefits assessments (see Section
I.A) to support the registration review of all the neonicotinoids, including imidacloprid. The
agency carefully considered the risks and benefits described in these assessments to develop the
risk mitigation proposals, which are detailed in this PID. In accordance with EPA policy, the
agency is opening a 60-day public comment period for the proposed mitigation described in this
PID prior to issuing a final decision.
Comments Submitted Concerning the Preliminary Pollinator Risk Assessments:
The agency received numerous comments in response to publication of the preliminary pollinator
risk assessments for clothianidin, dinotefuran, imidacloprid, and thiamethoxam, which were
considered in the preparation of the final pollinator risk assessments. The agency's responses can
be found below. These comments were received from BCS, Beekeepers (BK), Beyond Pesticides
(BP), the Center for Biological Diversity (CBD), California Citrus Mutual (CCM), the Center for
Food Safety (CFS), CropLife America (CLA), Dancing Bee Gardens (DBG), GreenCAPE (GC),
the National Corn Growers Association (NCGA), the National Cotton Council (NCC), the
Natural Resources Defense Council (NRDC), the National Wildlife Federation (NWF), the
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Pesticide Policy Coalition (PPC), the San Francisco Estuary Institute (SFEI), the University of
California - Riverside (UCR), the University of California - San Diego (UCSD), and the United
States Department of Agriculture (USDA).
The agency also received abundant generalized comments regarding the preliminary pollinator
risk assessments, including those concerning the scientific methodology or rationale in these
assessments. For a more comprehensive account of the comments related to the preliminary
pollinator risk assessments, including those summarized in this PID, refer to EFED Response to
Public Comments Common to the Preliminary Pollinator and Preliminary Non-Pollinator
Registration Review Risk Assessments Across the Four Neonicotinoid Pesticides (Imidacloprid,
Thiamethoxam, Clothianidin, andDinotefuran), available in the public dockets.
Summary of Comment (BCS): Bayer CropScience, commenting on behalf of the Imidacloprid
EPA DCI cost-sharing consortium (Bayer, Nufarm, Ensystex, Helena, UPI, and Albaugh),
expressed concerns over the kinetics model half-life estimates for imidacloprid. BCS asks that
the agency provide more accurate half-life estimates for imidacloprid.
EPA Response: The preliminary pollinator assessment for imidacloprid reported a half-life
range of 305 days to > 2,000 days. The agency has considered additional information since the
assessment was published and identified a half-life range of 139 days to 608 days. This refined
half-life range has a mean half-life of 254 days, which the agency used as the modeling input in
the final pollinator assessment (available in the docket).
Summary of Comments (BK, BP, CBD, CCM, CFS, DBG, GC, NCC, NRDC, NWF, SFEI,
UCR, UCSD): Several commenters asked the agency to refer to open literature studies for data
and/or methodologies to be incorporated into the EPA's pollinator assessment. These studies
covered a range of considerations including, but not limited to, assessing risk to additional
pollinator species (e.g. non-apis), sub-lethal effects, and toxicity endpoints.
EPA Response: The agency thanks the commenters for their comments. EPA relies on the best
available science at the time of conducting its assessments. In the risk assessment process,
numerous studies are considered and evaluated for inclusion in the assessments based on the
agency's open literature guidance. Open literature studies that meet the guidance criteria are then
selected for inclusion in the risk assessments. The selected studies are then weighted based on
the scientific evaluation. EPA acknowledges the growing body of studies/data/methodologies,
and has considered additional studies in the final pollinator assessments that were brought to the
agency's attention as comments received on the preliminary pollinator assessments.
Summary of Comments (Academia, BK, CBD, CFS, CLA, DBG, NRDC, NWF, PSC,
USDA, XSIC): Several commenters suggested the Tier II colony feeding studies were
inadequate, claiming design or conduct flaws (e.g. lack of overwintering, removal of colonies
due to supersedure, failure to consider genetic variability).
EPA Response: The agency reviewed the study protocols prior to test initiation and determined
that the study designs were appropriate for generating data for use in a regulatory risk
assessment. While EPA reviewed protocols and determined that the studies were appropriate for
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risk assessment, the agency acknowledges that there were some issues with the initial studies.
Therefore, EPA incorporated revised studies into the final pollinator assessments. These new
studies all included successful overwintering control hive components such as colony strength,
number of broods, food stores, etc., however, the agency notes that the treatment-related effects
measured after overwintering were equal to or less sensitive than those measured prior to
overwintering; since endpoints were based on effects observed during the season of the
application, they were also protective of effects that may occur after overwintering. Data
evaluation records for these studies are publicly available (regulations.gov; EPA-HQ-OPP-2011-
0581-0040 and EPA-HQ-OPP-2011-0865-0179) and list the perceived strengths and limitations
of these studies.
Summary of Comments: Several commenters expressed concerns that the agency did not
implement a consistent methodology for the four nitroguanidine-substituted neonicotinoids in the
preliminary pollinator risk assessments.
EPA Response: The agency thanks the commenters for their feedback. The initial registrations
for the four nitroguanidine-substituted neonicotinoids were not concurrent, and, as a result, the
registration review schedules for these chemicals were not concurrent. As such, the preparation
of the initial risk assessments for these four chemicals occurred at different times, where
imidacloprid was assessed prior to the remaining three nitroguanidine-substituted neonicotinoids.
However, since the release of the preliminary pollinator assessments, the agency has made a
programmatic decision to align the registration review schedules for all four nitroguanidine-
substituted neonicotinoids. Consequently, the final pollinator assessments are now aligned in
methodology and consistency to the greatest extent possible.
Summary of Comments: Several comments concerned the bee bread method to evaluate pollen
exposure. The nature of these comments include: an unvetted method should not be used in this
risk assessment (NCC, CBD, PPC); the bee bread method overestimates exposures to pollen in
the hive, and that these estimates should be converted to nectar equivalents that can be compared
to the sucrose No Observed Adverse Effects Concentration (NOAEC) (CLA, NCGA).
EPA Response: The agency thanks the commenters for their comments. Based on the public
comments received, and new data available, including a new colony feeding studies with spiked
pollen and a supplement of an expanded suite of available empirical residue in pollen and nectar
studies, the method to evaluate the pollen route of exposure has been updated in the final
pollinator risk assessments. In short, the updated approach considers exposure via contaminated
pollen (and nectar) on a total dietary basis by converting pollen concentrations into nectar
equivalents and summing the residues from both matrices (where appropriate) to estimate a
single exposure number for comparison to a sucrose-based endpoint (NOAEC). See Attachment
1. Tier IIMethod for Assessing Combined Nectar and Pollen Exposure to Honey Bee Colonies,
within each chemical-specific docket for a full explanation of the revised pollen method.
Comments Submitted Concerning the Preliminary Non-Pollinator Risk Assessments:
The agency received numerous comments in response to the preliminary non-pollinator risk
assessments conducted for the four nitroguanidine-substituted neonicotinoids, which were
considered in the preparation of the final non-pollinator risk assessments and comments
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concerned the scientific methodology or rationale in these assessments. These comments were
received from the, AVAAZ, the Bay Area Clean Water Agencies (BACWA), Bayer CropScience
(BCS), the California Department of Pesticide Regulation (CDPR), CropLife America (CLA),
the San Francisco Bay Regional Water Quality Control Board (SFBRWQCB), the Vermont
Agency of Agriculture Food and Markets (VAAFM), and Xerces Society for Invertebrate
Conservation (XSIC). The agency's response can be found below.
For a more comprehensive account of the comments related to the preliminary non-pollinator
risk assessments and their responses, including those summarized in this PID, refer to EFED
Response to Public Comments Common to the Preliminary Pollinator and Preliminary Non-
Pollinator Registration Review Risk Assessments Across the Four Neonicotinoid Pesticides
(Imidacloprid, Thiamethoxam, Clothianidin, and Dinotefuran) and Imidacloprid: Response to
Public Comments Related to the Preliminary Risk Assessments and Addendum to the Non-
Pollinator Risk Assessments in Support of Registration Review (Docket No. EPA-HQ-OPP-2008-
0844), available in the public dockets.
Summary of Comment (BCS): Bayer CropScience, on behalf of the imidacloprid EPA DCI
cost-sharing consortium members (Bayer, Nufarm, Ensystex, Helena, UPI, and Albaugh) noted
(EPA-HQ-OPP-2008-0844-1186) that the foliar rate for tobacco (0.561 kg a.i./ha) was
incorrectly listed in the seed treatment column of Table 3-6, p. 38 in the Preliminary Aquatic
Risk Assessment to Support the Registration Review of Imidacloprid.
EPA Response: The agency thanks BCS for their comment. The agency confirmed that there is
a typographical error in Table 3-6. The application rate (0.561 kg a.i./ha) should have been listed
under "soil application".
Summary of Comment (BCS): Bayer, on behalf of the imidacloprid EPA DCI cost-sharing
consortium members, noted (EPA-HQ-OPP-2008-0844-1187) that the "Commercial (Perimeter
Treatment): (0.5 lbs a.i./A, CA)" scenario in the Preliminary Aquatic Risk Assessment to Support
the Registration Review of Imidacloprid (see Table 5-3, p. 89), incorrectly indicates a LOC
exceedance for freshwater chronic risk.
EPA Response: The agency confirmed that there is a typographical error in Table 5-3. A chronic
RQ of 0.9 is below the LOC (1), and not a risk of concern.
Summary of Comment (CPDR and VAAFM): CPDR asserted that the neonicotinoid
assessments did not adequately consider the potential runoff from treated seeds planted greater
than 2 cm below the soil surface as the EPA's Pesticide Water Calculator (PWC) model used in
the assessment does not quantitatively estimate pesticide residues from treated seeds planted
below 2 cm. However, CPDR referenced monitoring data (Hladik et. al., 2014) that found that
pesticide detections in surface water can be associated with rainfall events following planting of
treated crop-seeds, thus suggesting a link between seed treatments and pesticide detections in
surface water. It was noted, though, that this study does not identify the depth at which the seed
treatments in question were planted. Additionally, VAAFM reported maximum concentrations of
neonicotinoids in the streams receiving effluent from tiles drains (see EPA-HQ-OPP-2008-0844-
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1175 for detail). CDPR suggested employing refined future modeling efforts to include soil
runoff modeling to account for subsurface flow such as tile drains commonly used in agriculture.
EPA Response: The agency thanks CDPR and VAAFM for their comments and submitting this
monitoring data. The agency recently re-evaluated its surface water modeling for seed
treatments. The agency no longer models applications "at depth", which could potentially
overlook pesticide residues in runoff from treated seeds planted at depths below 2 cm. Instead,
the agency has elected to use the "increasing with depth" application of the PWC model, which
assumes that some portion of the applied chemical will be available to runoff, even when planted
at depth. These assumptions were implemented in the models included in the comparative
aquatic neonicotinoid risk assessment and associated documents, which identified acute and
chronic risk exceedances for aquatic invertebrates (see Section III.B.l of this PID).
Moreover, the agency is proposing label language to mitigate potential risks from runoff. The
proposed label language covers treated seeds, but also includes statements for spray and foliar
applications. For a detailed description of the proposed label language please refer to Section
IV. A. 8 and Appendix B.
Summary of Comments (AVAAZ, BACWA, CDPR, CLA, SFBRWQCB, XSIC):
Commenters (EPA-HQ-OPP-2008-0844-1192, EPA-HQ-OPP-2008-0844-1116) assert that
ample evidence exists in the literature to show that relatively small concentrations of
neonicotinoids can trigger harmful effects; that invertebrates are harmed at levels well below the
current aquatic life benchmarks, and that these benchmarks should be revised. The commenters
also felt that the following studies should be considered in the assessments:
• Maloney, E. M., Morrissey, C. A., Headley, J. V., Peru, K. M., & Liber, K. (2017).
Cumulative toxicity of neonicotinoid insecticide mixtures to Chironomus dilutus under
acute exposure scenarios. Environmental Toxicology and Chemistry, 36(11), 3091-3101.
• Miles, J. C., Hua, J., Sepulveda, M. S., Krupke, C. H., & Hoverman, J. T. (2017). Effects
of clothianidin on aquatic communities: Evaluating the impacts of lethal and sublethal
exposure to neonicotinoids. PloS One, 12(3), e0174171.
• Raby, M., Nowierski, M., Perlov, D., Zhao, X., Hao, C., Poirier, D. G., & Sibley, P. K.
(2018). Acute toxicity of 6 neonicotinoid insecticides to freshwater invertebrates.
Environmental Toxicology and Chemistry, 37(5), 1430-1445.
Conversely, one commenter (EPA-HQ-OPP-2008-0844-1562) asserted that the application of the
most conservative endpoint to assess risk to all aquatic invertebrates is overly conservative and
does not account for diversity of aquatic invertebrate communities.
EPA Response: The agency thanks the commenters for their feedback. The agency has
considered the additional information provided from the above studies. Raby et. al. conducted a
comparative analysis by testing the four nitroguanidine-substituted neonicotinoids on 7 aquatic
invertebrate species in a controlled laboratory environment. The agency also performed a cursory
review of Maloney et. al. and Miles el.al, which report lethal concentrations (LCso) similar to
those reported in Raby et. al. Overall, the agency found the Raby et. al. study acceptable for
quantitative use in risk assessment, however, the agency concluded that there are no significant
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changes in the risk conclusions for aquatic invertebrates as described in the preliminary
ecological risk assessments. For more information, refer to the Comparative analysis of Aquatic
Invertebrate Risk Quotients generatedfor neonicotinoids using Raby et al. (2018) toxicity data
available in each docket.
II. USE AND USAGE
Imidacloprid is a nitroguanidine neonicotinoid insecticide with the first product registered for use
in the United States in 1994. Products containing imidacloprid are used to control a variety of
sucking and piercing insect pests including thrips, aphids, and whiteflies, as well as soil insects
such as beetles, grubs, and wireworms. Products containing imidacloprid are formulated as
wettable powders, granules, seed treatment, trunk injection and soluble concentrates on a wide
variety of agricultural and non-agricultural use sites. Agricultural sites include but are not limited
to vegetable crops, tree fruits, tree nuts, and field crops as well as forestry (including lumber and
pulp production; non-agricultural uses include but are not limited to turf and ornamental plants,
and indoor and outdoor residential and commercial sites including pet products. There are over
five hundred FIFRA § 3 and § 24 (c) registrations in the United States, including eighteen
registrations for the technical grade active ingredient.
Agricultural Usage
The largest agricultural use for imidacloprid, in terms of pounds active ingredient (AI) applied,
has been in the form of seed treatments. On average, between 2005 and 2015, over 700,000 lbs.
of imidacloprid were used annually for seed treatments on various field crops including corn,
cotton, soybean, potato, and wheat2. There are also seed treatments registered for various
vegetable crops. More recent data on seed treatment usage are not available.
From 2007-2017, soil and foliar usage averaged about 800,000 lbs. AI3, applied to
approximately 5.6 million acres4 annually. Agricultural sites with the highest usage of
imidacloprid in average pounds applied per year are cotton (100,000 lbs), oranges (80,000 lbs),
and potatoes (80,000 lbs)3. The highest percent crop treated (PCT) values are reported for
broccoli (70%), cauliflower (70%), and lettuce (70%)3.
In 2016, approximately 5,000 pounds of imidacloprid was reported to be used for industrial
vegetation management, including forestry5.
2 Imidacloprid (129099) Screening Level Usage Analysis (SLUA), March 14, 2017
3 Imidacloprid (129099) Screening Level Usage Analysis (SLUA), December 9, 2019
4 Agricultural Market Research Data (AMRD). 2007-2017. Data collected and sold by a private market research
firm. Data collected on pesticide use for about 60 crops by annual surveys of agricultural users in the continental
United States. Survey methodology provides statistically valid results, typically at the state level.
5 Non-agricultural Market Research Data (NMRD), 2017. Data on consumer and professional pest control
markets collected and sold by a private market research firm.
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Non-Agricultural Usage
The agency has limited usage data on non-agricultural use sites. In 2016, approximately 300,000
lbs of imidacloprid was used by pest management professionals {i.e., applicators who typically
apply pesticides to turf and ornamental plants, including in residential areas)5. Additionally,
approximately 40,000 lbs of imidacloprid was purchased in 2016 directly by consumers for
indoor and outdoor use.
III. SCIENTIFIC ASSESSMENTS
A. Human Health Risks
A summary of the agency's human health risk assessment is presented below. The agency used
the most current science policies and risk assessment methodologies to prepare a risk assessment
in support of the registration review of imidacloprid. For additional details on the human health
assessment for imidacloprid, see the Imidacloprid: Human Health Draft Risk Assessment for
Registration Review, Imidacloprid: Updated Residential Exposure Assessment in Response to
Draft Risk Assessment (DRA) Comments, and Imidacloprid. Updated Non-Occupational Spray
Drift Exposure Assessment in Response to Draft Risk Assessment (DRA) Comments, which are
available in the public docket.
1. Risk Summary and Characterization
Humans may be exposed to imidacloprid in food and drinking water from crop uses, residential
applications, in occupational settings, and from exposures to spray drift. The primary target
system for mammals via the oral route is the nervous system; observed effects include
tremors/trembling, decreased motor activity, etc., in multiple neurotoxicity studies in the dog and
rat. No signs of toxicity were observed through the dermal and inhalation routes in the available
studies and there was no evidence of carcinogenic potential in the database. Imidacloprid is
classified as a Group E chemical ("Evidence of non-carcinogenicity for humans"), oral Toxicity
Category II (high oral lethality), and dermal Toxicity Category IV (low lethality by the dermal
and inhalation routes). Because the toxicology database is sufficient to support risk assessment,
the assessments are unlikely to underestimate exposure, and the observed neurotoxic and fetal
and offspring effects are well characterized and protected for, and the FQPA Safety Factor was
reduced to IX. Therefore, the level of concern (LOC) for all assessments is 100 based on the
interspecies (10X) and intraspecies (10X) extrapolation. The toxic effects used by the agency to
estimate risk in the human health assessment are based on evidence of neurotoxicity in the 90-
day rat study. As a result of information received as part of public comments, EPA has drafted an
updated assessment, Imidacloprid: Updated Residential Exposure Assessment in Response to
Draft Risk Assessment (DRA) Comments, which is available in the public docket.
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Dietary (Food + Water) Risks
The acute dietary assessment assumed tolerance-level residues for most registered commodities,
and all crops were assumed to have 100% of the crop treated. No acute dietary risks of concern
were identified, as all populations resulted in acute population adjusted doses (aPAD) of less
than 100% which is HED's level of concern. The highest exposed population subgroup was
children 1-2 years old with an aPAD of 93%.
The chronic dietary assessment also assumed tolerance-level residues but incorporated average
percent crop treated for several commodities. All chronic exposure analyses were below the level
of concern. The most highly exposed population subgroup was children 1-2 years old at 12% of
the chronic population adjusted dose (cPAD).
Residential Risks
Residential uses of imidacloprid include lawns and gardens, homes, commercial establishments,
crack-and-crevice treatments, pet uses, structural pest control, and wood preservation. Generally,
short-term dermal and incidental oral post-application exposures (short-term) are expected as a
result of these residential uses, with the exception of intermediate- and long-term exposures from
the pet collar and spot-on uses, as they present the potential for prolonged exposure via a
continuous source and frequent contact {i.e., playing with pets).
All residential handler scenarios resulted in margins of exposure (MOEs) greater than HED's
LOC of 100, which makes these risks not of concern. MOEs ranged from 110 to 950,000; the
lowest MOE was associated with applying pet collars to large dogs. Since the previous human
health risk assessment, the combined residential post-application exposure risk estimates for the
pet collar use have been updated and are no longer of concern {i.e., MOEs > the LOC of 100) for
all scenarios.
The post-application residential MOEs (combined dermal and inhalation) for foliar spray and
granular irrigated turf are not of concern (MOEs > LOC of 100) however, there are risk estimates
that indicate potential concern for adults (dermal exposure, high-contact activities), and children
1 to <2 years old (dermal exposure, high contact activities and hand-to-mouth) using additional
turf transferable residue (TTR) data submitted during the public comments on the human health
risk assessment from the foliar and granular non-irrigated plots. Following review of this data,
the agency updated its exposure assumptions, resulting in these risks of concern. For children 1
to <2 years old, combined dermal and incidental oral estimates are of concern with an MOE of
25, dermal high-contact play on treated turf scenarios resulted in an MOE of concern of 36, and
the hand to mouth scenario resulted in an MOE of concern of 83. For adults, the high-contact
play modeled scenario resulted in an MOE of concern of 71. Detailed discussion of this data and
the resulting risks of concern are in, Imidacloprid: Human Health Draft Risk Assessment for
Registration Review and Imidacloprid: Updated Residential Exposure Assessment in Response to
Draft Risk Assessment (DRA) Comments, available in the imidacloprid docket.
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Bystander Risks
Previously, a quantitative spray drift assessment for imidacloprid was not required because the
residential turf post-application MOEs was not of concern and was protective of bystander risks.
After review of the TTR data submitted during the public comment period, non-occupational
spray drift exposure was reassessed and determined to not be of concern. For more information
please see, Imidacloprid. Updated Non-Occupational Spray Drift Exposure Assessment in
Response to Draft Risk Assessment (DRA) Comments, available in the imidacloprid docket.
Occupational Risks
Most occupational handler risk estimates were not of concern (i.e., MOEs > 100) with current
baseline attire (long-sleeved shirt, long pants, shoes and socks) or with personal protective
equipment (PPE and gloves). The exception was for workers performing activities related to: on-
farm seed treatment to barley, canola, cotton, millet, and wheat (MOEs ranged from 4 to 94); the
handgun application for citrus (MOE = 58); and seed planter exposure for flax which showed a
slight exceedance (MOE = 98). Workers conducting seed treatment on barley and cotton would
need to wear double layer clothing and gloves to reach acceptable MOEs; for workers applying
imidacloprid to citrus using handguns, only the addition of gloves would be needed; uses such as
canola, millet, and wheat show lower MOEs ranging from 4 to 37, which would require further
mitigation such as conducting applications in commercial seed treatment facilities, to reduce
risks below EPA's level of concern.
The occupational post-application dermal exposure assessment resulted in MOEs greater than the
LOC of 100 and were not of concern; MOEs ranged from 440 to 4,800.
Cumulative Risks
EPA has not made a common mechanism of toxicity to humans finding for imidacloprid and any
other substance, and it does not appear to produce a toxic metabolite produced by other
substances. Therefore, EPA has not assumed that imidacloprid has a common mechanism of
toxicity with other substances for this assessment.
2. Human Incidents and Epidemiology
An incident review was conducted from January 1, 2000 to August 27, 2008 and there were a
large number (436) of single chemical incidents involving imidacloprid reported in the Office of
Pesticide Program's Incident Data System (IDS). In the most recent IDS analysis, including
search results from January 1, 2011 to April 26, 2016, 44 incidents were reported for single
chemical (exposure to imidacloprid only), and 518 incidents reported for multiple active
ingredients (combined exposure to imidacloprid and other active ingredients). In the aggregate
IDS, 2,828 incidents were reported involving imidacloprid. In addition, the Sentinel Event
Notification System for Occupational Risk (SENSOR) was queried from 1998 to 2013, and 318
cases involved imidacloprid (114 involved only imidacloprid). A query of the National Pesticide
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Information Center (NPIC) from January 1, 2010 to December 31, 2015, identified 111
incidents, and 96 of those were reported to the California's Pesticide Incident Surveillance
Programs (PISP) involving imidacloprid and other chemicals (2010 to 2013).
Since the 2017 draft human health risk assessment, a new human health incident memo,
Flumethrin: Tier I Update Review of Human Incidents and Epidemiology for Proposed Interim
Decision, was posted to the docket. Although the report was made as part of the flumethrin
registration review, all incidents noted were from a single combined flumethrin-imidacloprid
product (Seresto™ Collar, EPA Reg. No. 11556-155) and incorporate incidents from January 1,
2016 to August 27, 2019. During this time in the Main IDS there were 252 human health
incidents reported that involved the active ingredient imidacloprid. Of these 252 incidents, 19
were classified as major severity and 233 were classified as moderate severity. In Aggregate
IDS, there were 374 human health incidents reported involving imidacloprid. These incidents
were classified as minor severity.
Of the 19 major severity incidents in main IDS that were further reviewed, the symptoms most
often reported were dermal (8) and neurological (7). However, a patient could exhibit multiple
symptoms. Dermal symptoms reported include rash, redness, skin lesions, hives, and pruritus.
Neurological symptoms reported include headaches, numbness, tingling and one person reported
seizures. The total number of imidacloprid incidents reported to IDS, from 2013 to 2018,
appeared to be increasing over time. The agency will continue to monitor the incident data and if
a concern is triggered, additional analysis will be conducted.
3. Tolerances
Tolerances for imidacloprid are established on a variety of raw agricultural and livestock
commodities for the U.S.; for Canada, Mexico and Codex the residue definition is harmonized.
However, there are many international tolerances that are not harmonized with the U.S.
tolerance. Most cannot be harmonized because the U.S. uses have higher application rates, and
thus higher tolerance levels. The agency proposes increasing the US tolerances for residues of
imidacloprid on citrus fruits and coffee to harmonize with Canada and Codex MRLs.
Additionally, EPA is proposing eliminating trailing zeros listed in tolerances consistent with
agency policy. All proposed tolerance revisions for imidacloprid are listed in Appendix E:
Summary of Proposed Tolerance Actions.
4. Human Health Data Needs
The human health database for imidacloprid is complete. No additional data is needed for the
imidacloprid registration review.
B. Ecological Risks
A summary of the agency's ecological risk assessment is presented below. The agency used the
most current science policies and risk assessment methodologies to prepare a risk assessment in
support of the registration review of imidacloprid. For additional details on the ecological
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assessment for imidacloprid, see the following documents, which is available in the public
docket (EPA-HQ-OPP-2008-0844) at www.regulations.gov.
o Preliminary Aquatic Risk Assessment to Support the Registration Review of
Imidacloprid
o Imidacloprid Transmittal of the Preliminary Terrestrial Risk Assessment to
Support the Registration Review
o Final Bee Risk Assessment to Support the Registration Review of Imidacloprid
o Comparative Analysis of Aquatic Invertebrate Risk Quotients generatedfor
neonicotinoids using Raby et al. (2018) toxicity data
The EPA is currently working with its federal partners and other stakeholders to implement an
interim approach for assessing potential risk to listed species and their designated critical
habitats. Once the scientific methods necessary to complete risk assessments for listed species
and their designated critical habitats are finalized, the agency will complete its endangered
species assessment for imidacloprid. See Appendix C for more details. As such, potential risks
for non-listed species only are described below.
5. Risk Summary and Characterization
Terrestrial Exposure
Imidacloprid is applied through aerial and ground application methods, which includes sprayers,
chemigation and soil drenching, and seed treatment. For terrestrial wildlife, the agency modeled
potential dietary exposure based on consumption of imidacloprid residues on food items
following spray (foliar or soil) applications as well as from ingestion of residues on treated seeds.
For treated seeds, different seed sizes and planting rates could result in a range of exposures.
EPA also considered potential bird and mammal dietary exposure from fields where applied
manure from poultry house operations may contain imidacloprid residues resulting in
contamination of food items (e.g., insects) and/or incidental ingestion of contaminated soil
particles.
Overall, acute risks to avian and mammalian species from foliar and soil treatments of
imidacloprid appear to be low. Soil incorporation following soil treatments, including
incorporation of treated poultry litter, decreases potential risks from this use pattern
considerably. Exposures from treated seed results in the highest acute and chronic risks to
terrestrial organisms. However, the risks vary considerably. A low number of small treated seeds
(e.g. lettuce and sugar beets) are required to reach levels of concern for smaller birds and
mammals because the surface of these seeds have higher concentrations of a.i. applied. Also,
these smaller seeds are easier for small birds and mammals to consume because of their small
size. However, larger seeds (e.g. corn and soybean) pose far lower risks to birds and mammals
because lower concentrations of a.i. are applied to the seed surface. Also, the larger size of these
seeds prevents smaller birds and mammals from consuming them.
For terrestrial invertebrates, the primary routes of exposure assessed include contact of bees with
spray droplets and oral ingestion via pollen and nectar. Additionally, exposure can occur from
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seed treatment dust. Exposure can vary based on use patterns and the attractiveness of a treated
crop.
For terrestrial plants, available data indicate they are not sensitive to imidacloprid up to 2X its
maximum single foliar application rate of 0.25 lb a.i./A. Therefore, exposure modeling (and risk
estimation) for terrestrial plants was not conducted.
Mammals - Risk Estimates
Imidacloprid is classified as moderately toxic to mammals on an acute oral exposure basis.
Chronic exposure in the Norway rat (Rattus norvegicus) resulted in reductions in parental and
offspring body weight. The chronic mammalian risk quotients (RQs) calculated for imidacloprid
were based on the chronic mammalian rat 2-generation reproduction NOAEL of 16.5 mg/kg-
bw/d. Potential risk was evaluated at three different weight classes of mammal: small (15 g),
medium (35 g), and large (1000 g). Further details on mammalian risks are provided below.
Foliar Applications: There were no acute risks of concern via foliar applications for mammalian
species of any weight class, even when assessed using the maximum registered single application
rate of 0.4 lb a.i./A (RQs <0.01 - 0.11; LOC = 0.5). Acute RQs were highest for small mammals
feeding on short grass.
There were no chronic LOC exceedances on a chronic dietary basis for all application rates
(highest RQ = 0.44; LOC = 1.0), but there were exceedances for dose-based RQs for 15 of 17
uses (highest RQ = 2.9 on citrus/pome). Expected risks rose with increases in the modeled
application rate and for smaller sized mammals.
Soil Applications: There were no acute risks of concern via soil applications for mammalian
species of any weight class even when assessed using the maximum registered single application
rate of 0.4 lb a.i./A (RQs <0.01 - 0.37). Acute RQs decreased with weight class and were highest
for small mammals feeding on short grass.
There were no chronic LOC exceedances on a chronic dietary bases for all application rates
(highest RQ = 0.19), but there were dose-based risks of concern for 18 uses (highest RQ = 1.2).
Expected risks rose with increases in the modeled application rate and for smaller mammals. No
exceedances to mammals were noted from use on poultry litter.
Treated Seed Applications: RQs were calculated for six crops (corn, soybean, cotton, wheat,
sorghum, and potato) when assessing potential risks to mammals from imidacloprid-treated
seeds. Modeled uses were selected to be representative of high acreage crops (e.g., corn,
soybean, cotton), to provide a range of application rates (e.g., sorghum 0.023 to potato 0.878 lb
a.i./A) and present a range of application rate to seed size ratios. The acute species LOC was
exceeded for four of the six scenarios (RQs ranged from <0.01 to 1.1; LOC = 0.5) for dose-based
exposures. The highest acute RQ exceedances were for use on cotton.
The chronic LOC was exceeded for all size classes of mammals consuming each of the assessed
treated seed with the exception of potato (RQs ranged from 0.3 to 29; LOC = 1.0), indicating
potential chronic risk. The highest chronic RQ exceedances for treated seed was for cotton.
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Mammals - Risk characterization
There are several variables impacting exposure to mammals from seed treatments, such as how
far apart and how many seeds are available at a given time, the amount of cover provided by
field conditions (newly planted fields are likely to be open and provide less cover than no till
fields, making them less attractive as a forage location for smaller mammals), and whether or not
seeds are on the surface of a field vs. incorporated into the soil. Seeds buried below the soil
surface are not as easily found by foraging mammals, reducing the potential for exposure and
increasing the amount of time required to find them, which in turn decreases the likelihood of
potential chronic exposure. However, some mammals are highly capable of burrowing in soil
and acquiring buried seeds and may cache them for later consumption. In addition, in the case of
chronic risks, the impact of consuming treated seeds may vary by life stage. It is currently an
uncertainty whether effects seen in laboratory-based reproduction studies occur at a specific
sensitive life stage or are due to exposure over the entire exposure period.
Another source of uncertainty are the scaling factors used to predict toxicity in different size
mammals. This is important because the number of seeds a mammal needs to consume before
toxicological effect are expected varies by the size of the mammal, with larger mammals
requiring a larger dosage for toxicological effects to be likely. According to the agency's
Imidacloprid Transmittal of the Preliminary Terrestrial Risk Assessment to Support the
Registration Review, the percent of a mammals' diet that would need to be imidacloprid-treated
seed in order to exceed the acute level of concern would be 34-78% for sorghum/wheat seed, 37-
82% for corn seed, 160-331%) for soybean seed, 47-96%> for cotton seed, and 2200-3688%) for
potato seed, depending on mammal size. Dietary percentages greater than 100%> indicate a low
potential for risk while risk increases as the dietary percentage decreases below 100%> since it is
presumed more likely that a mammal would consume smaller fraction of its diet from the treated
field. The highest potential risk scenario identified was small (<15g) mammals consuming
sorghum seed. In this example, an individual small sized mammal would need to consume 34%
of its daily diet as treated sorghum/wheat seed in a day to exceed the acute level of concern.
Although our risk estimates indicate the potential for acute risks of concern, specifically for
smaller sized mammals, there is uncertainty associated with the percentage of an individual
mammal is likely ot be treated seed. Overall, risk of concern is more likely from chronic (long-
term) consumption of treated seed.
Birds, Reptiles, and Terrestrial-Phase Amphibians - Risk Estimates
Imidacloprid is characterized as highly toxic to birds on an acute oral exposure basis and slightly
toxic on a subacute dietary exposure basis. Japanese quail (Coturnix coturnix japonica)
represents the most sensitive acute toxicity endpoint while mallard duck (Anasplatyrhynchos)
represents the most sensitive chronic toxicity endpoint with effects on egg production, egg
hatchability, and adult body weight. Further details on ecological risks to birds, reptiles, and
terrestrial phase amphibians from exposure to imidacloprid are provided below. Note that birds
are used as surrogates for potential risks to terrestrial-phase amphibians and reptiles.
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Foliar Applications: For foliar applications of imidacloprid, there were no acute or chronic risks
of concern for birds on a dietary basis even when calculated using the maximum registered foliar
single application rate of 0.4 lb a.i./A (RQs <0.01 - 0.86; LOCs = 0.5 for acute risks and 1.0 for
chronic risks). Acute exceedances were identified on a dose basis with RQs ranging from <0.01
to 9.8 among all bird types, dietary items, and uses. Small and medium size herbivorous birds
have the greatest frequency of exceeding the acute risk LOC, with exceedances in all 17 crop
scenarios (representing 26 registered use patterns) for at least 3 of the 4 dietary categories. For
large herbivorous birds, acute dose-based RQs range from 0.02 to 1.2, and LOC exceedances
mainly occur for birds consuming short grass. For insectivores, acute dose-based RQ values
range from 0.13 to 3.8 and exceed the acute LOC for small and medium insectivores, except for
marginal exceedances for tree nuts and citrus/pome fruits. Lowest overall risk from foliar
applications of imidacloprid is expected for granivores, with no exceedances of the acute risk
LOC. RQs decreased with avian weight class and were highest for small birds feeding on short
grass. In practice, given that most herbivorous avian species are expected to be classified as large
birds (>1,000 g), it is unlikely that herbivorous species will be at risk. However, it is possible
that smaller omnivorous species that consume available foliage (e.g., seedlings) may be at risk.
Soil Applications: The potential for acute risk to birds consuming contaminated arthropods was
identified for small and medium size birds for all crop exposure scenarios modeled (RQ range =
0.68 to 4.2). Chronic dose-based RQ values were not calculated for birds per the T-REX model.
On a dietary basis, acute risk was not indicated (maximum acute RQ = 0.03). On a chronic
dietary basis, risks to birds are not indicated since the chronic RQ values are below the LOC for
all uses (RQs range from 0.14 to 0.38).
Based on an acute analysis (LDso/ft2) for soil applications of imidacloprid, the acute LOC was
exceeded for small and medium size birds for all crop exposure scenarios modeled (acute RQ
range from 1.2 to 20). For large birds, the crop uses with the highest application rates (e.g., bulb
vegetables, fruiting vegetables, citrus) slightly exceed the acute LOC of 0.2 with an RQs of 0.23.
Potential risk to birds from use in poultry litter was not assessed in the terrestrial draft
imidacloprid risk assessment.
Seed Treatment Formulations: As mentioned previously in the section for mammals, RQs
representing potential risks to birds from imidacloprid-treated seeds were calculated for various
crops and rates. Expected risks are highest for small birds and decrease with increasing avian
body weight. For small and medium birds, there are acute dose-based LOC exceedances for all
crops (RQs range from 0.15 to 99). For large birds, there are acute dose-based species LOC
exceedances for birds feeding on soybean, wheat, corn, sorghum, and cotton seeds. On a chronic
basis, the LOC was exceeded for birds consuming all of the assessed treated seeds (RQs ranged
from 1.0 to 41). The highest chronic exceedances for all sizes of birds was from treated cotton
seed with an RQ of 41.
Birds. Reptiles, and Terrestrial-Phase Amphibians - Risk characterization
In field conditions, the exposure of birds to imidacloprid seed is dependent upon many variables
beyond the amount of active ingredient on a given treated seed. These factors include whether or
not the treated seed is buried or on the surface of a field (as in the case of an accidental seed
spill), the depth at which buried seed is buried, the number and density of treated areas across the
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landscape, and the seed size relative to the size and foraging patterns of birds. For birds of any
size, the attractiveness of the treated seed as a source of food is relative to the color or size of
other available food sources. The size of a bird is also important in predicting effects expected
from exposure, because larger birds generally need to consume more treated seeds before
toxicological effects are observed.
Based on the agency's Imidacloprid Transmittal of the Preliminary Terrestrial Risk
Assessment to Support the Registration Review, the percent of which a bird's diet would need to
consist of imidacloprid-treated seed in order to exceed the acute level of concern would be only
3% for field corn seed (risk only to large birds), 12% soybean seed (risk only to large birds), 1-
4% cotton seed, and 1-3% sorghum/wheat seed, depending on bird size. The highest risk was
identified for small size birds which would need to consume less than a single treated sorghum
and wheat seed to exceed the acute level of concern, while with small or medium size birds
consuming cotton, sorghum, and wheat seed, a bird would only need to consume 1-4 seeds [two
(cotton) or four (sorghum and wheat)] to exceed the acute level of concern.
The size of a treated seed relative to the size of a given bird is another important variable to
consider when characterizing potential risks from imidacloprid-treated seed. In the case of small
birds, treated seeds which are large either due to pelleting or the size of an individual seed, may
be too big for a small bird to swallow. Based on minimum weights of field corn seed (-225 mg),
and cotton seed (-100 mg), these seeds are considered too big for most small passerine birds to
consume. Examples of seeds too large for small passerine (20g) bird consumption includes are
field corn, soybean, cotton, and potato. Therefore, acute and dietary risks from consumption of
these seeds can be discounted for these size classes of passerines. Field corn and potato seeds are
also considered too big for medium-sized passerine birds to consume. Other types of corn seed
(e.g., sweet, pop, etc.) exhibit a size range such that the average seed size is below the weight
threshold for medium-sized passerines. Consequently, medium-sized passerines could still
potentially be affected by consuming other corn varieties.
The largest birds would physically be able to consume a wider range of treated seeds, due to their
size, but would need to consume a greater number of seeds than their smaller counterparts to
experience negative health effects. As an example, for large birds foraging in cotton fields, 4% of
their diet would have to be made up of the imidacloprid-treated seed in order to reach the species
acute LOC compared to 1% of a medium bird's diet. Given the potential availability of other
seed sources (i.e. remaining waste grain or seeds from weed species on the field), eating diets
made up entirely of a specific seed type is unlikely but may be more likely in instances of treated
seed spillage than through normal foraging behavior.
Terrestrial Invertebrates - Risk Estimates
This section incorporates information provided in the Preliminary Pollinator Assessment to
Support the Registration Review of Imidacloprid as well as the more recent Final Bee Risk
Assessment to Support the Registration Review of Imidacloprid, which are available in the public
docket. The initial preliminary pollinator assessment published in 2016 evaluated the potential
risk associated with the registered agricultural uses of imidacloprid to bees alone. The 2016
assessment utilized available data at the time. This included a robust registration review required
dataset to help characterize the acute and chronic toxicity of imidacloprid to adult and larval
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honeybees at the Tier I (individual bee effects) level. In each assessment (2016 and 2019), a
plethora of available open literature data were also reviewed in addition to the required data.
The final 2019 bee risk assessment then updates the preliminary pollinator assessment and
incorporates additional information submitted to the EPA since the previous assessment. This
new assessment also includes additional residue study data, which provide information on
residues of imidacloprid in nectar, pollen, and other plant matrices for registered crop uses; as
well as a residue bridging strategy to extrapolate residue data among crops, chemicals, and plant
matrices to address lack of residue data for certain crops between the neonicotinoids where
appropriate. This additional information includes higher tiered (Tier II and III) data. Tier II data
included both semi-field tunnel (rate-response) and feeding (dose-response) studies to help better
evaluate potential colony-level effects, and tier III data evaluated colony-level effects which
represented a more real-world scenario, however was associated with more uncertainty.
Imidacloprid is unique compared to the other neonicotinoids as it had the availability of Tier III
full-field studies conducted on pumpkin and cotton, which were incorporated into the recent
assessment. Data were requested based on a tiered approach, as lower tiered data could trigger
the need for higher tiered data.
During the scoping of the registration review for imidacloprid, the agency identified the need to
assess risk to terrestrial invertebrates. As a result, the agency issued requirements for a robust set
of pollinator data, which included both exposure and toxicity data, along with higher tiered
pollinator tests such as Tier II (semi-field) and Tier III tests (full field). During testing,
honeybees (Apis mellifera) were used as a surrogate for other species of bees (e.g. bumblebees,
solitary bees). Risks to these other non-Apis bees are evaluated qualitatively based on available
information. As the pollinator risk assessment framework used by the EPA indicates, honeybees
are intended to be reasonable surrogates for other bee species, and conclusions from the weight
of evidence for the honeybee can be used to help inform about potential risks to other non-Apis
species. An exception is noted based on the differences in attractiveness of crops to different bee
species.
Among the four neonicotinoids (imidacloprid, clothianidin, thiamethoxam, and dinotefuran),
robust data sets of pollen and nectar residue data are available for foliar and/or soil applications
to the following bee-attractive crops and crop groups: cotton, cucurbits, citrus, stone fruit, pome
fruit, tree nuts, berries/small fruits, and ornamentals. Surrogate residue data from the other
neonicotinoids were used to represent uses on crops where limited or no residue data were
available. Generally, the imidacloprid risk assessment found that foliar or soil applications of
imidacloprid to honeybee attractive crops that are not harvested prior to bloom result in the
potential for colony-level risks of concern. Risks associated with pre-bloom applications are
generally greater than those associated with post-bloom applications.
Based on the evaluated data, imidacloprid is classified as very highly toxic to adult honeybees
with acute oral and acute contact LD50 values of 0.0039 and 0.043 |ig a.i/bee, respectively. For
larval toxicity, there was no acute oral study available. At the Tier 1 (individual bee) level, acute
contact RQs ranged from 2.5 to 31 (LOC = 0.4). Acute oral exposure to adult honey bees
foraging on the treated field based on refined exposure (measured residues) from foliar
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applications resulted in RQ exceedances up to 32 (orange), soil use RQ exceedances up to 126
(ornamentals), and combined foliar and soil exceedances up to 208 (cotton). The highest acute
exceedances were from uses on citrus, pome fruit, ornamentals and turf.
For chronic oral toxicity to adult bees, a 10-day study indicated a No Observed Adverse Effect
Concentration (NOAEC), at 0.0011 |ig a.i/bee/day. The Lowest Observed Adverse Effect
Concentration (LOAEC) based on significant effects on food consumption for this study was
0.0018 |ig a.i/bee/day. A 21-day chronic toxicity test did not show significant effects up to and
including the highest concentration tested, 40 |ig a.i/L (equivalent to 0.00183 |ig a.i/bee). At the
Tier 1 (individual bee) level, chronic adult oral RQ exceedances from on-field foliar use of
imidacloprid based on refined exposure (measured residues) are up to 86 (orange), soil use
exceedances are up to 224 (ornamental), foliar and seed exceedances are up to 7.7 (cotton) and,
foliar and soil exceedances are up to 518 (cotton) (LOC = 1.0). Like with the acute risk
exceedances, the highest chronic risk exceedances noted were from uses on citrus, pome fruit,
ornamentals and turf.
Based on an analysis of Tier I data, for foliar applications, potential off-field dietary risks to
individual bees exposed to spray drift extend greater than 1000 feet from the edge of the treated
field. There is uncertainty in this analysis including: assumptions on available attractive forage
off field, use of individual level toxicity data, BeeREX default estimates for residues, and
unrefined AgDRIFT™ modeling. Soil applications are assumed to have a low off-field risk
because of low potential to drift.
Off-field estimates of risk are based on screening-level exposure estimates, which cannot be
refined with available residue data. Moreover, these estimates relied on assumptions regarding
crop-attractiveness to bees, exposures, cultural practices {i.e. harvest cycles), environmental
conditions {i.e. canopy coverage), wind conditions (i.e. unidirectional and constant), etc.
Therefore, potential off-field risks may be overestimated. Additionally, exposure to individual
bees from off-site movement of abraded seed dust during planting is noted as a potential
exposure route of concern.
Imidacloprid exposure to pollinators also exists where applications are made to poultry litter
manure in broiler houses which are later used as outdoor fertilizer. Due to neonicotinoid
persistence in the environment, poultry litter use resulted in acute risks of concern for bees when
applied at the maximum allowed rate (0.032 - 0.756 lb a.i./A) and number of applications (six
whole house treatments) and then utilized as fertilizer on agricultural fields. Based on that
maximum rate, RQs calculated using the Bee-REX model showed exceedances up to 5.5 (larval
chronic) and up to 21 (adult chronic). For the lowest application rate of 0.032 lb ai/A, RQ values
are 0.23 (larval chronic) and 0.91 (adult chronic); below the LOC of 1.
On a colony-level, potential risks were identified for several scenarios. Since risks to honey bees
were identified at the Tier 1 (individual bee) level, the Agency evaluated risks at the colony level
(Tier II and Tier III). At the Tier II level, this involved comparing imidacloprid residues
measured in pollen and nectar in various crops to levels that affect honey bee colonies. At the
Tier III level, this involved analysis of full field studies that were conducted for pumpkin and
cotton. These Tier III studies contained significant uncertainties associated with the study design
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and availability of data which limited their utility. These uncertainties include the origin of the
pollen and nectar brought back to the hives, high variability in the data collected (including in
control hives), and inadequate replication or pseudo-replication (e.g. studies conducted using
only one field). Ecological incidents were also considered as a line of evidence. For a detailed
explanation of these risk estimates, please refer to the Final Bee Risk Assessment to Support the
Registration Review of Imidacloprid, available in the docket. The findings of the higher tier
assessment are summarized below.
Terrestrial Invertebrates - Risk Characterization
The agency utilized several lines of evidence to better refine the risk calls including:
incorporating information on crop bee attractiveness, agronomic practices (e.g., harvest time
relative to bloom) to determine if exposure was present, a comparison of residues to adverse
effects levels for entire hives (residues above NOAEC and LOAEC), and major categories of
incidents. For comparison of residues to adverse effects levels for entire hives, EPA considered
duration and frequency of exceedance, the magnitude of exceedance (including the ration of max
residue value to NOAEC/LOAEC and percent of diet from the treated field needed to reach the
NOAEC/LOAEC), as well as consideration of usage and geographic scale/spatial distribution of
exposure.
It is important to note that multiple factors can influence the strength and survival of bees
whether they are solitary or social. These factors, including disease, pests (e.g., mites), nutrition,
and bee management practices, can confound the interpretation of studies intended to examine
the relationship of the test chemical to a receptor (i.e., larval or adult bee). Therefore, most
studies attempt to minimize the extent to which these other factors impact the study; however,
higher-tier studies afford less control over these other factors, and their role may become
increasingly prominent as the duration of the study is extended. Although studies attempt to
minimize the confounding effects of other environmental factors, there is uncertainty regarding
the extent to which the effects of a chemical may be substantially different had these other
factors not been present.
Strongest Evidence of Risk: For foliar and soil applications of imidacloprid, the lines of evidence
are considered "strongest" for supporting the finding of colony-level risk resulting from
applications to (with corresponding application method and timing of application with highest
level of concern):
• citrus, banana/plantain (foliar and soil, pre-bloom),
• cotton (combined foliar + soil)
• berries (foliar and soil, pre-bloom),
• cucurbits (soil)
• attractive fruiting vegetables (chilies, peppers, foliar and soil), and
• attractive ornamentals and forest trees (foliar, soil)
These findings are supported by multiple lines of evidence indicating that residues exceed the
imidacloprid colony-level endpoints by a high magnitude, frequency and/or duration. In some
cases, they are also supported by modeled residues or ecological incidents involving bees that are
associated with the use.
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Moderate Evidence of Risk: For foliar, soil, and trunk injection application of imidacloprid, the
strength of evidence is considered "moderate" in indicating a colony-level risk to honeybees for
the following registered uses:
• citrus (soil, post-bloom),
• tree nuts (soil, post-bloom),
• cotton (foliar and soil),
• turf (including residential lawns), and
• ornamentals and forestry (trunk injection).
These findings are supported by lines evidence indicating that residues exceed the imidacloprid
colony-level endpoints but the magnitude, frequency and/or duration of exceedance is limited. In
some cases, residues exceed only for a subset of sites or crops, possibly due to the impact of soil
type (e.g., soil applications to cotton).
Weakest Evidence of Risk: For foliar, soil and seed treatment applications of imidacloprid, the
strength of evidence is considered "weakest" in indicating a colony-level risk to honeybees for
the following registered uses:
• root/tubers (foliar, soil),
• legumes (soil, seed, beans),
• citrus (foliar, post-bloom),
• pome and stone fruit (foliar & soil, post-bloom),
• herbs and spices (foliar, soil),
• tropical fruit (foliar & soil, post-bloom), and
• hops/peanut (foliar, soil, seed)
Terrestrial Plants
Imidacloprid was not found to be toxic to terrestrial plants when tested up to its maximum single
application rate. Due to the low sensitivity of terrestrial plants to imidacloprid applications up to
the maximum single rate, a quantitative risk assessment was not conducted for terrestrial plants.
Aquatic Risks
Imidacloprid is applied through aerial and ground application methods, which includes sprayers,
chemigation and soil drenching, and seed treatment. For aquatic wildlife, the agency modeled
potential exposure based on the likelihood of imidacloprid residues reaching aquatic
waterbodies. Imidacloprid's chemical properties indicate it is readily soluble in water and that
volatilization and bioaccumulation in aquatic organisms are negligible. Imidacloprid is
considered persistent in aquatic environments with the exception of conditions that favor
aqueous photolysis. The major routes transporting imidacloprid from treatment sites to aquatic
habitats include runoff and spray drift.
Freshwater Invertebrates
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Based on the Preliminary Aquatic Risk Assessment to Support the Registration Review of
Imidacloprid dated December 22, 2016, acute and chronic risks of concern to freshwater
invertebrates for imidacloprid were identified for both agricultural and non-agricultural soil,
foliar, and combined application method uses. All uses associated with foliar spray and
combination application methods showed the potential for acute and chronic risks to freshwater
invertebrates. Acute RQs ranged from <0.01 to 44 and exceeding the LOC of 0.5, while chronic
RQs ranged from <0.01 to 2130 exceeding the chronic LOC of 1.0. Chronic freshwater RQ
exceedances were generally highest for combined applications (39 to 2130), then foliar (82 to
1020), followed by soil (<0.01 to 699), and then seed (<0.01 to 84). A similar trend was seen
with acute risks of concern.
Comparative Analysis of Aquatic Invertebrate Risk Quotients
While imidacloprid had a fairly comprehensive dataset for the agency to estimate potential
aquatic risk, the other neonicotinoids in this group had much more limited dataset for the draft
aquatic risk assessment. The agency generated a Comparative analysis of Aquatic Invertebrate
Risk Quotients generatedfor neonicotinoids using Raby et al. (2018) toxicity data, which
became available following publication of the Preliminary Aquatic Risk Assessment to Support
the Registration Review of Imidacloprid (2016). The studies, located in the docket, were used to
determine RQs using acute and chronic toxicity data provided in the two open literature papers
published by researchers from the University of Guelph, Raby data (Raby et al. 2018a6 and Raby
et al. 2018b7). With use of the available raw data, EPA determined the results could be used
quantitatively for risk assessment purposes {i.e., to derive RQs). Upon the review of the Raby
data, risks of concern were identified for all four neonicotinoid insecticides (dinotefuran,
clothianidin, thiamethoxam, and imidacloprid) to freshwater invertebrates on both an acute and
chronic basis.
On an acute basis across all tested species, LCso values for dinotefuran were similar, but slightly
higher than imidacloprid. LCso values for clothianidin on average were 2.4 times higher than
those of imidacloprid and dinotefuran, suggesting that clothianidin may be somewhat less toxic
on an acute basis than imidacloprid and dinotefuran. Thiamethoxam LCso values were 5.6 times
higher than those of imidacloprid across all tested species, suggesting that thiamethoxam is
potentially the least toxic on an acute basis.
All four neonicotinoids present risks of concern to freshwater invertebrates on a chronic basis as
well, with clothianidin and imidacloprid having similar toxicity, dinotefuran being -2.3 times
less sensitive, and thiamethoxam being -5.3 times less sensitive than imidacloprid and
clothianidin based on midge data (which was generally more sensitive than mayfly, the other
tested species in the chronic test). There is a -4 times difference in sensitivity across the four
neonics with dinotefuran being the least sensitive; despite an almost 20 times difference between
1 Raby, M; Nowierski, M.; Perlov, D; Zhao, X.; Hao, C; Poirier, D.G. and P.K. Sibley. 2018a. Acute Toxicity of 6
Neonicotinoid Insecticides to Freshwater Invertebrates. Environmental Toxicology and Chemistry, 37 (5): 1430-
1445. MRID 50776401.
7 Raby, M; Zhao, X.; Hao, C.; Poirier, D.G. and P.K. Sibley. 2018b. Chronic toxicity of 6 neonicotinoid insecticides
to Chironomus dilutus and Neocloeon triangulifer. Environmental Toxicology and Chemistry, 37 (10): 2727-2739.
MRID 50776201.
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mayfly toxic endpoints. There is a similar trend with the mayfly data with dinotefuran (and
thiamethoxam) being the least sensitive.
Two notable uncertainties with the Raby data include: 1) inconsistent analytical verification of
concentrations, and 2) differing control performance in the imidacloprid testing.
For 1), not all test concentrations were confirmed through analytical verification. As a result, the
LCso and NOAEC values are based on nominal concentrations. From the limited subset of test
concentrations that were analyzed, the measured values were similar to the nominal
concentrations, and is not expected to have a substantial impact on the reliability of the acute and
chronic toxicity values.
For 2), the chronic midge test showed a reduction in the performance of control organisms with
regards to growth and reproductive endpoints, relative to controls in the other tests. Due to this,
there is potential that the imidacloprid midge toxicity endpoints underestimate the actual toxicity
of imidacloprid to midges. However, the chronic endpoint used for comparison of the
neonicotinoids done by the agency was the percent emergence endpoint, which for the
imidacloprid controls did meet EPA test method standards and was generally one of the most
sensitive endpoints across chemicals.
Both mayfly and midge studies tested all four neonicotinoids, however when considering
exposure, dinotefuran tended to have the highest estimated exposure concentrations (EECs)
among the four chemicals. The other three neonicotinoids were estimated to have similar EECs
to each other. On an acute basis, for the mayfly and midge acute RQs, the majority of
clothianidin and dinotefuran RQs were greater than those of imidacloprid. Thiamethoxam
appears to present a lower acute risk concern when considering the midge RQs. On a chronic
basis more generally, clothianidin, dinotefuran, and imidacloprid, have similar chronic RQs with
a few exceptions: tree fruit RQs for imidacloprid were eleven times higher than the other A.I.s;
foliar nursery and soil forestry applications RQs for clothianidin were an order of magnitude
higher than imidacloprid; foliar and soil applications as well as seed treatment RQs for
imidacloprid were 13-220 times higher than thiamethoxam. Overall thiamethoxam was found to
have lower exceedances to aquatic invertebrates than the other three nitroguanidine
neonicotinoids.
Estuarine/Marine Invertebrates
Acute risks were not identified for saltwater invertebrates. Chronic risks to saltwater
invertebrates were identified for all application methods with RQs ranging from <0.01 to 131.
The highest exceedances being identified from combined uses (2.4 to 131) followed by foliar
(5.0 to 63), soil (<0.01 to 43), then seed treatment (<0.01 to 5.1) (LOC = 1.0).
Freshwater/Estuarine/Marine Fish and Aquatic-Phase Amphibians
The Preliminary Aquatic Risk Assessment to Support the Registration Review of Imidacloprid,
dated December 22, 2016, noted no direct risks of concern to fish or aquatic phase amphibians
from any of the agricultural or non-agricultural uses assessed. The limited number of aquatic
incidents reported for imidacloprid indicate a lack of direct adverse impacts on fish.
Furthermore, available monitoring data indicate detected concentrations of imidacloprid are
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several orders of magnitude below levels shown to cause adverse effects in fish and aquatic-
phase amphibians. While the potential risk of direct effects of imidacloprid to fish and
amphibians is considered low, the potential exists for indirect risks to fish and aquatic-phase
amphibians through reduction in their invertebrate prey base.
Aquatic Vascular and Non-Vascular Plants
Potential imidacloprid risk to aquatic plants is expected to be low. Aquatic plants were not
assessed as available data for vascular and non-vascular aquatic plants indicate toxicity endpoints
that are several orders of magnitude above the highest EECs in surface waters.
6. Ecological Incidents
Ecological incidents were noted as possibly stemming from imidacloprid usage for several taxa.
The certainty of these incidents stemming directly from imidacloprid use varies. It is important
to note incident information serves as one line of evidence, and that the absence of reports does
not indicate an absence of general incidents or pollinator losses due to pesticides.
Terrestrial non-pollinator incidents
A review of the Environmental Information Incident System (EIIS) incident database yielded 16
reported terrestrial organism incidents from 1995 to 2017. These incidents are discussed in more
detail in, Imidacloprid Transmittal of the Preliminary Terrestrial Risk Assessment to Support
the Registration Review. For incidents originating from foliar applications, the reports primarily
concern plant damage to agricultural crops, but are all associated with either "unlikely" or
"possible" certainty indices due to the presence of multiple pesticides or no confirmatory residue
analysis to confirm the presence of imidacloprid.
For the soil or ground-applied related incidents reported, 4 of the 7 incidents (57%) were
associated with a "possible" certainty. Three of these incidents involved deaths to birds, yet there
was no confirmatory residue analysis conducted in any of these cases to implicate imidacloprid
or any other chemical as the cause of the mortality. In two other reports associated with higher
certainty, plant damage was the reported effect, although at least one of these reports cites a
misuse of the chemical. As described previously, imidacloprid did not show significant effects to
ten species of plants at the highest application rate (0.5 lbs. AI/A) permitted, therefore it is
unlikely to be the cause of the incident. In a recent (2016) report, 25 American goldfinches were
reported dead shortly following a soil drench application to elm trees with a product containing
75% imidacloprid. A subsequent residue analysis of the livers and stomachs detected
imidacloprid residues at 2.1 and 2.2 ppm, respectively, which indicates imidacloprid's presence
in the bird. The pathology report also noted grass seeds in the stomachs of the birds.
For the sole report associated with a seed treatment application, although a large number of birds
were reported as allegedly dying due to ingestion of imidacloprid-treated wheat seeds, a
subsequent residue analysis did not detect imidacloprid in the birds. This incident was
categorized as "possible."
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For 3 of the 4 incidents in the unknown method of application category, the incidents appear to
be associated with homeowner lawn care products, specifically grub control products. Although
these incidents list damage to the homeowner lawns, the relevancy of these incidents relative to
others where agricultural crops and or avian and mammalian wildlife is concerned is low given
that homeowner-applied products are subject to a greater chance of misuse relative to those made
by certified applicators.
Aquatic incidents
The incident database (1995 to 2017) also noted two wildlife incident reports concerning aquatic
organisms {i.e., fish and invertebrates). Both incidents were associated with non-agricultural uses
of imidacloprid on turf. One of these incidents was notably a misuse, which in addition to
imidacloprid, also contained the pesticides thiophanate-methyl and deltamethrin, the latter of
which is known to be more toxic to fish which was the affected species in the incident report.
These two aquatic incidents are categorized in more detail in, Preliminary Aquatic Risk
Assessment to Support the Registration Review of Imidacloprid.
Pollinator incidents
The source of pollinator incidents includes not only EIIS but registrant reports submitted under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) §6(a)(2) reporting requirement,
as well as reports from local, state, national and international level government reports on bee
kill incidents, news articles, and correspondence made to the agency by phone or via email
(through beekill@epa.eov) generally reported by homeowners and beekeepers. These incidents
are described in more detail in, Final Bee Risk Assessment to Support the Registration Review of
Imidacloprid, in the imidacloprid docket.
14 of the 19 incidents summarized either included a follow-up investigation that confirmed
through residue analysis the presence of imidacloprid in at least one matrix (dead bees, floral
pollen, nectar), or were submitted by the registrant under FIFRA 6(a)(2), which provides a
higher confidence of imidacloprid being associated with these incidents. Ten of these incidents
originated from an agricultural use while others were mainly from residential and commercial
use on ornamentals. In some of these instances, other chemicals (including other neonicotinoid
chemicals) were also detected. For others, the incident was determined to originate from a
misuse of imidacloprid.
Of the ten incidents reported on agricultural crops, half were from soil applications and half were
from seed treatment applications. Of the soil applications, four reported dead honeybees near
citrus and soybean fields, while one reported dead bumble bees in greenhouse tomatoes. Most
non-agricultural incidents involved applications to ornamental tree species; linden, arbutus, and
laurel.
Several other incident reports were more anecdotal in the narrative, as they provided information
without a confirmatory residue analysis such as news reports and beekeeper organization
newsletters. Of the incidents that provided a residue analysis, imidacloprid concentrations of
dead bee samples were quantified as high as 2,456 |ig/L.
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Pet incidents
The EPA has received and evaluated numerous pet incidents since imidacloprid's registration in
1994; however, a comparative assessment of pet incidents across all registered pet products
based on usage data is not available. The agency is conducting similar analyses on other
pesticides registered for direct treatments to pets, such as spot-ons, and may consider conducting
such analyses for other active ingredients with products registered for direct treatments to pets,
such as collars. EPA has been engaged with stakeholders on a variety of different actions to
address potential risks to pets from the use of pet spot-on products; additional information on this
project can be found here: https://www.epa.gov/pets/epa-evaluation-pet-spot-products-analysis-
an d-pl an s-reducin g-harmful-effects. As additional information is gathered through this project,
EPA will be evaluating the use of pet products generally, including those that contain
imidacloprid, to determine if additional changes are needed to pet product registrations.
The agency will continue to monitor ecological incident information as it is reported to the
agency. Detailed analyses of these incidents are conducted if reported information indicates
concerns for risk to non-target organisms.
7. Ecological and Environmental Fate Data Needs
The ecological and environmental fate database for imidacloprid is complete. No additional data
are needed for the imidacloprid registration review.
C. Benefits Assessment
The EPA conducted a number of use site-specific benefits assessments for the neonicotinoids as
a pesticide class. Each assessment considered the advantages of the individual neonicotinoid
active ingredients, including their use in targeting particular pests, average application rates,
acres treated, and potential alternatives, which are described in detail in the benefits assessments
available in the docket (see section l.A. for a full list of available benefits documents).
The agency found that as a group, the neonicotinoid insecticides:
can control a variety of piercing and sucking pests including those that vector plant
diseases such as aphids and whitefly;
each show certain benefits for the control of particular pests;
offer both immediate, contact control and systemic, residual control of pests over an
extended period of time;
are comparatively less expensive and more effective than some alternatives;
For imidacloprid specifically, the agency found benefits of usage includes selective activity, a
unique mode of action for resistance management, systemic and translaminar activity, minimal
toxicity to most predatory or parasitoid insects, and the capacity to target hard-to-control pests.
Imidacloprid usage suggests it provides superior control of aphids and whitefly (while other
neonicotinoids are beneficial for control of other insects). Alternatives to imidacloprid,
depending on the crop or use site and target pest, include organophosphates, pyrethroids, and
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carbamates, as well as alternative nitroguanidine and chloropyridinyl neonicotinoids such as
thiamethoxam and acetamiprid, respectively.
The following are summaries of the benefits assessments available in the public docket8:
Cotton
An average of 6.4 million acres of cotton are treated with a neonicotinoid insecticide. EPA
estimates that almost 69% of acres receive at least one application of a neonicotinoid primarily
with imidacloprid and thiamethoxam. Accounting for multiple treatments per acre, nearly 9
million acres of cotton are treated with neonicotinoids annually; imidacloprid accounts for about
35% of these acres. Imidacloprid is applied primarily via seed treatment but is also registered for
foliar and soil treatments. An average total of 3.2 million acres are treated with imidacloprid
annually with a total of 192,000 average pounds of active ingredient applied at an average
application rate of 0.060 lbs. AI/A. The vast majority of treated cotton acreage is via seed
treatment at rates below the overall average. Rates of at-plant soil applications and in-season
foliar applications average 0.169 lbs AI/A and 0.071 lbs AI/A, respectively. Of cotton foliar
applications (both via ground and aerial applications), imidacloprid accounts for over half of the
neonicotinoid use in terms of pounds applied but less than 40% of the acres treated.
Foliar usage of imidacloprid in cotton most commonly targets plant bugs, aphids, and stink bugs.
There are regional differences in pest pressure. Stink bugs are somewhat more common targets
in the Southeast than in the Mid-South and Plains states. In the Plains states, the primary target
pest is the fleahopper. These pests cause a variety of damage throughout the growing season and
can account for not only early season yield losses but in the case of "sticky cotton", when lint
and other contaminants adhere to cotton processing equipment, caused by late season whiteflies
and aphids, limiting the viability and sale of final product. Without imidacloprid or other
nitroguanidine neonicotinoids, growers would probably use a combination of an
organophosphate with a pyrethroid, such as acephate or dicrotophos with lambda-cyhalothrin or
bifenthrin, which would increase costs - and lower income - by $3 to $7/acre, depending on the
region.
For more information, see Benefits of Neonicotinoid Insecticide Use in the Pre-Bloom and Bloom
Periods of Cotton, available in the public docket.
Citrus
Based on information from market research data, imidacloprid and thiamethoxam were the main
neonicotinoid active ingredients used on citrus groves nationally from 2011 - 2015. On average,
104,000 pounds of imidacloprid were used annually on 274,000 acres of citrus with over 417,000
total acres treated with imidacloprid for an average of 1.5 applications per year. Neonicotinoids
are used on citrus as part of programs to control the Asian citrus psyllid (ACP), a vector for
Huanglongbing bacterial disease (HLB), also known as citrus greening disease. HLB is currently
incurable; it negatively affects both the quantity and quality of fruit and may kill trees within a
few years. Without imidacloprid, used in conjunction with other neonicotinoids, growers would
increase use of other insecticides such as organophosphates and pyrethroids like acephate,
8 https://www.regulations.gov/doeket?D=EPA~HQ~OPP~2008~Q844
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dicrotophos, bifenthrin, lambda-cyhalothrin, and cyfluthrin, as well as acetamiprid, a
chloropyridinyl neonicotinoid. Control costs would increase, and control would likely be
compromised as well, leading to an increased number of trees infected with HLB, which would
have to be removed and replaced at substantial cost.
In citrus production, neonicotinoids are also used to control a variety of other insect pests such as
aphids, leafminers, citrus rust mite, fuller rose beetle, and scale insects, that occur outside the
bloom period.
For more information, see Benefits of Neonicotinoid Insecticide Use in the Pre-Bloom and Bloom
Periods of Citrus, available in the public docket.
Grape
Pesticide usage data from 2013 -2017 indicate that over 500,000 acres of grapes are treated
annually in the U.S. with imidacloprid, or around 50% of table, raisin, and wine grapes.
Applications are most often made post-bloom, but imidacloprid is also a leading insecticide prior
to and during bloom. Extension guides recommend imidacloprid in a regiment for most grape
insect pests. The primary target pests are leafhoppers, including sharpshooters, and mealy bugs,
with the grape berry moth and Japanese beetle being important pests of grapes in the northeast.
Damage from these pests can result in quality and yield reductions. Sharpshooters vector Pierce's
Disease which is a fatal bacterial disease for grapes that can result in 100% yield loss.
Imidacloprid provides rapid control via contact activity and residual control through systemic
activity. More generally, neonicotinoids are important rotation partners for resistance
management.
Neonicotinoids provide substantial benefits to grape growers, given that the alternative
insecticides are limited and/or more expensive depending on target pest. If imidacloprid and
other neonicotinoids were unavailable, yield and quality loss, including losses from disease,
would be likely.
For more information, see Benefits of Neonicotinoid Insecticide Use in Grapes and Impacts of
Potential Mitigation, available in the public docket.
Rice
While EPA conducted a benefits assessment for rice, imidacloprid is not registered for use in rice
and thus was not included in the rice benefits assessment.
Stone Fruit
The stone fruit benefits assessment included apricot, sweet and tart cherries, peaches/nectarines,
and plums/prunes as well as several other varieties and hybrids. The proportion of U.S. cherry
crop treated with either imidacloprid (40%) or thiamethoxam (23%) is substantial while
applications to peach/nectarine crop treated with neonicotinoids is far less, imidacloprid makes
up the most with 8%. For apricot and plums/prune, about 5% of the crop is treated with
imidacloprid, while use of other neonicotinoids is negligible. Thus, the focus of the benefits
assessment was on cherry and peach.
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Pests on stone fruit for which imidacloprid may be used include plum curculio, aphids, cherry
fruit fly, stink bugs, plant bugs, oriental fruit moth, and spotted wing Drosophila. Of these, plum
curculio is a significant pest for which post-bloom control is critical. However, among the
nitroguanidine neonicotinoids, thiamethoxam is considered more efficacious than imidacloprid
for this pest. Plum curculio is a beetle which deposits eggs on or near developing fruit. Its larvae
feed inside fruit and this can lead to fruit drop or cosmetic damage to larger fruit (USDA 2011).
In addition, buyers and processors have a zero-tolerance policy for infestations, and detection of
a single larva will result in rejection of the entire harvest from a given orchard block.
Imidacloprid is more often utilized to manage fruit flies, another critical pest in terms of both
yield/quality loss and the threat of harvest rejection, as any fly infestation in harvested fruits also
faces a 'zero tolerance' policy among buyers. Aphids targeted by imidacloprid use can be
occasionally serious pests, particularly to young trees. The spotted wing Drosophila is a tiny
"vinegar" fly, native to east Asia, which was accidentally introduced into the United States in
2009. It prefers soft-skinned fruit for oviposition and (unlike fruit flies) has the ability to lay eggs
in undamaged fruit. Like the curculio and fruit flies, Drosophila larvae are internal fruit feeders,
and feeding increases the incidence of fungal and bacterial diseases in the affected fruit. Among
stone fruit, however, cherries are most vulnerable to this pest, though it can be found on ripe
plums and peaches as well. Due in part to the difficulty of detecting this tiny insect, its damage,
and the zero tolerance among buyers for any infestation in the harvest, cherry growers in
particular rely on frequent treatments of multiple insecticides in affected areas. Imidacloprid is
one of these options.
For more information, see Assessment of Usage, Benefits and Impacts of Potential Mitigation in
Stone Fruit Production for Four Nitroguanidine Neonicotinoid Insecticides (Clothianidin,
Dinotefuran, Imidacloprid, and Thiamethoxam), available in the public docket.
Pome Fruit
Imidacloprid is applied to approximately 158,200 total acres of pome fruit with a total of
approximately 18,700 pounds applied (2013-2017). Imidacloprid use on Western apples accounts
for approximately 95% of the total acres treated with nitroguanidine neonicotinoids.
Imidacloprid is applied at an average rate of 0.106 lbs. AI/A for Western apples and 0.128 lbs.
AI/A for Eastern apples. Imidacloprid is also used on pear, about 11% of the acres grown are
treated at an average rate of 0.204 lbs. AI/A.
Imidacloprid is used for the control of pear psylla and mealybugs in pear and aphids and brown
marmorated stink bug (BMSB) in apple production. These target pests can result in quality and
yield loss. The majority of imidacloprid use is during the post-bloom to harvest periods of the
pome fruit production cycle. However, 20-30% of the pome fruit crop is treated with
neonicotinoids during the pre-bloom and bloom periods. For aphid control in Western apple
production, imidacloprid is the second most used insecticide, following chlorpyrifos, during the
pre-bloom and bloom periods, and the number one control option post-bloom. Early season
control can be important to manage early season pests that can build up to high population
densities if not controlled early season.
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For more information, see Usage, Pest Management Benefits, and Possible Impacts of Potential
Mitigation of the Use of the Four Nitroguanidine Neonicotinoids in Pome Fruits (Apple, Pear),
available in the public docket.
Berries
Berries refer to strawberry, caneberry (blackberry, raspberry, etc.), cranberry, and blueberry, as
well as multiple other small soft fruit grown on very small acreage. Neonicotinoids, of which
imidacloprid is often the most commonly used, provide both contact and systemic control of
numerous economically significant pests in berry crops. Imidacloprid is used for the control of
strawberry aphids, spittlebug, potato leafhopper, and whiteflies in strawberry; aphids, potato
leafhopper, spotted wing drosophila (SWD), and thrips in caneberry; blackheaded fireworm,
cranberry flea beetle, rootgrubs/rootworms, and weevils in cranberry; and aphids, sharpnosed
leafhopper, blueberry maggot, and Japanese beetle in blueberry. These target pests cause direct
feeding damage which can cause reductions in the aesthetic quality of harvested fruit (e.g.,
Japanese beetle), transmit diseases which can result in plant death and/or crop loss (e.g., aphids,
leafhoppers, whiteflies), and can present damage during harvest that can potentially result in
complete crop rejection, of a grower's entire field (e.g., blueberry maggot).
A very high proportion of caneberries and blueberries are treated with imidacloprid while about
ten percent of strawberry acreage is treated with imidacloprid. Data are not available for
insecticide usage in cranberry. The alternatives to imidacloprid vary by crop and target pest and
consist primarily of organophosphates, pyrethroids, flupyradifurone and acetamiprid in
strawberry; organophosphates and pyrethroids in caneberry; organophosphates and spinosyns in
cranberry; and acetamiprid, pyrethroids, organophosphates, and carbamates in blueberries.
Imidacloprid, compared to its alternatives, offers flexibility of application method, cheaper cost
compared to some alternatives, superior control compared to some alternatives, and longer
residual control which reduces the number of applications needed resulting in further reduction
of application costs.
For more information, see Benefits of NeonicotinoidInsecticide Use in Berries (Strawberry,
Caneberry, Cranberry, and Blueberry) and Impacts of Potential Mitigation, available in the
public docket.
Cucurbits
The cucurbits benefits assessment for the neonicotinoids includes usage in cantaloupes,
watermelon, squash, cucumber, and pumpkin from emergence to harvest in the Western,
Southern, and Northern production regions. Key pests treated by neonicotinoids include
whiteflies and aphids. Imidacloprid is the most utilized neonicotinoid active ingredient on
cucurbits followed by dinotefuran. Imidacloprid is applied most to cantaloupe (8,600 lbs. AI/A
annually); however, in total, an average of 26,000 pounds of imidacloprid are applied annually to
cucurbits.
According to pesticide market research data (2013-2017), imidacloprid is the most commonly-
used insecticide prior to crop emergence. Imidacloprid is most commonly used on cucurbits to
target aphids both prior-to-crop emergence and crop emergence-to-vining followed closely by its
use to target cucumber beetle.
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For more information, see Benefits of NeonicotinoidInsecticide Use in Cucurbit Production and
Impacts of Potential Risk Mitigation, available in the public docket.
Other Crops: Fruiting vegetables, Brassica vegetables, Leafy Green vegetables, Tree Nuts, Root
& Tuber vegetables, Bulb vegetables, Herbs, Peanut, Legume Vegetables, and Tropical and
Subtropical Fruit
Neonicotinoids provide both contact and residual control of several important insect pests,
primarily piercing and sucking pests that feed off the sap of plants and that may vector disease.
Because they are systemic, both soil and foliar applications can be used, permitting growers
flexibility in terms of application timing and method. Neonicotinoids are less widely used in
production of bulb vegetables, succulent and dried legumes, peanut, and certain tropical fruits
like avocados, dates, and olives. In these crops, target pests may be uncommon or rarely
damaging and/or there are cost effective alternatives. Data for some small-acreage crops, such as
herbs, are not available from which to draw conclusions.
In general, usage of imidacloprid is highest among the neonicotinoids. Most of the neonicotinoid
usage in tree nuts is associated with imidacloprid although relatively little is used in almond
production. Imidacloprid is also the primary neonicotinoid used in production of tropical fruits,
for which acreage in the continental United States is generally very small. Of the crops grown on
more than 10,000 acres, usage of imidacloprid is high in pomegranate, but low in avocado, dates,
and olive. On peppers and tomatoes, 32% and 65% of the acreage is treated with imidacloprid,
respectively. Similarly, the percent of acres treated with imidacloprid is high in most of the leafy
vegetables and Brassica vegetables, ranging from nearly 35% to 75%. Imidacloprid is also the
primary neonicotinoid used in production of root and tuber crops; over 20% of carrot acreage
and over 35% of potato acreage are treated with imidacloprid, often by chemigation. However,
10%) or less of peanut, dry and succulent beans and peas, and bulb vegetables are treated with
imidacloprid.
To some extent, other neonicotinoids could be used as alternatives to imidacloprid. However, the
pest spectrum is slightly different; imidacloprid tends to provide control over a greater range of
sucking and piercing insects. Dinotefuran is not registered for use in tree crops; thiamethoxam is
the only other nitroguanidine neonicotinoid registered for foliar application in carrot and
imidacloprid is the only neonicotinoid registered for soil and foliar applications in legumes and
peanut. Absent imidacloprid, alternative pest control strategies would vary widely across these
crops and pests. Broad-spectrum insecticides such as organophosphates and pyrethroids may be
used in some situations; more selective insecticides possibly in conjunction with insect growth
regulators might be feasible in other situations. Few, if any, of these options have systemic
activity and multiple applications may be needed to provide similar control to a single
imidacloprid application.
F or more information, see Benefits of Neonicotinoid Use and Impacts of Potential Mitigation in
Vegetables, Legumes, Tree Nuts, Herbs, Tropical and Subtropical Fruit Crops, available in the
public docket.
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Turf and Ornamentals
The registrants of neonicotinoid insecticides commissioned a series of reports, prepared by the
agricultural consulting firm Aglnfomatics in 2014 on the value of neonicotinoids, or equivalently
the impacts of a ban on their use on turf and omamentals in the United States and Canada. The
reports quantified the agronomic, environmental, and socio-economic values of neonicotinoids
using a Choice Experiment to homeowners and professionals who manage turf and omamentals.
The turf and ornamentals industries in the U.S. account for over 400,000 businesses, millions of
jobs, and billions in annual revenues. Turf and ornamentals add value to the homes of consumers
through various means such as aesthetics, recreation, energy and water conservation. Insects can
damage areas with turf and omamentals, and thus reduce their value to consumers. Over 19,000
homeowners were surveyed by Aglnfomatics and segmented into three markets based on the
predominate "homescape" type: "flowers and shrubs," "lawns," and "trees." Over 700 turf and
ornamentals professionals were surveyed through various professional associations and
segmented into five business types: trees, greenhouse, lawn, nursery, and landscape ornamentals.
The results of the homeowner survey showed that homeowners value neonicotinoid insecticides.
The top concerns of homeowners applying insecticides to their homescape center around efficacy
and safety (humans, pets, wildlife and bees) according to the data gathered in the choice
experiment. The results show that when given a choice between two options, both of which are
efficacious and safe for humans, the homeowners preferred the option that had the additional
attribute of being safe on bees.
The results of the professional survey showed that professionals value neonicotinoids because
professionals reported that neonicotinoids offer systemic properties; exhibit long-term efficacy;
and provide a low-risk to the applicators, customers and their pets. The most used neonicotinoid
active ingredient was imidacloprid (75% of survey respondents), followed by dinotefuran (17%),
clothianidin (3%) and thiamethoxam (3%). Based on the results of this report, the most difficult
pests to manage in the absence of neonicotinoids would be aphids, borers, white grubs, armored
scales and whiteflies, respectively. Professionals stated that the negative business impacts from
the absence of neonicotinoids would be driven mostly by the cost increases associated with the
use of alternatives (e.g., chemical and labor costs) and lower customer satisfaction. The possible
alternatives in the absence of the neonicotinoids in order of preference are pyrethroids,
organophosphates, avermectins, carbamates, and diamides.
Results from the econometric analysis using the Choice Experiment indicated that homeowners
had different willingness to pay for pesticides based on their attributes. Although the authors
used a rigorous approach, there were inconsistencies between model results and interpretation of
results in the text. For example, Aglnfomatics" survey omitted pertinent information relevant to
the decision-making process of consumers. These omissions resulted in conclusions where
Aglnfomatics overvalued or undervalued the benefits of neonicotinoids within certain
homeowner market segments relative to alternatives.
In addition to the homeowner and professionals" surveys, there were three case studies
completed by Aglnfomatics highlighting the benefits of neonicotinoids to control Southern
chinch bugs in turf, silverleaf whiteflies in ornamentals, and emerald ash borers in trees. The
emerald ash borer case study provided additional support on the value of neonicotinoids.
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including imidacloprid in USD A pest management programs for additional invasive species
(e.g., spotted lantern fly, Asian longhorned beetle) attacking trees on federal lands.
Although there were areas for improvement in the report's methodology, results, and general
conclusions; EPA agrees with Aglnfomatics that neonicotinoids are a useful tool and often a top
choice for pest control in the turf and ornamental industries.
For more information, see Review of "The Value of Neonicotinoids in Turf and Ornamentals"
prepared by Aglnfomatics, LLC for Bayer CropScience, Mitsui, Syngenta, and Valent, available
in the public docket.
IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION
A. Proposed Risk Mitigation and Regulatory Rationale
As discussed previously, EPA recognizes that the neonicotinoids, including imidacloprid, are a
key tool for growers that provide unique and effective pest control. However, the agency has
identified ecological risks of concern, particularly to pollinators and aquatic invertebrates, as a
result of many of the same attributes that make the neonicotinoids effective pest management
tools. Risk mitigation measures are being proposed to address human health risks of concern
from imidacloprid to occupational handler and residential post-application scenarios; and
ecological risks of concern identified for pollinators, birds, mammals, and to aquatic
invertebrates, as described in Section III.
Risks of concern were identified to aquatic invertebrates, which play a foundational role in
aquatic ecosystems. The agency is proposing several risk mitigation measures for reducing
exposure to aquatic invertebrates, including targeted annual application rate reductions, along
with spray drift and runoff management measures.
Risks of concern were identified to honeybees in EPA's assessments. The protection of honeybee
populations is particularly important as honeybees play a critical role in the pollination needs of
many U.S. crops. In 2017, pollination services from operations with more than 5 colonies were
valued at over 160 million dollars, and annual honey production in the US was valued at over
340 million dollars9. Although the focus of the pollinator risk assessments is on honeybees, the
agency recognizes that numerous other species of bees occur in North America and that these
non-Apis bees have ecological importance in addition to commercial importance in some cases.
For example, it is important to note that several species of non-Apis bees are commercially
managed for their pollination services, including bumble bees (Bombus spp.), leaf cutting bees
(Megachile rotundata), alkali bees (Nomia melanderi), blue orchard bees (Osmia lignaria), and
the Japanese horn-faced bee (Osmia cornifrons). Importantly, a growing body of information
indicates native bees play an important role in crop and native plant pollination, in addition to
their overall ecological importance via maintaining biological diversity. EPA is therefore
9 USD A, National Agricultural Statistics Service (NASS), Agricultural Statistics Board. (2018).
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proposing mitigation that reduces impact to honeybees that are also expected to benefit other
pollinating insects. Of these measures, reductions in maximum application rates for certain crops
where pollinator/bee exposure may occur, or crop stage restrictions which limit exposure during
critical periods in the growing season, are expected to have the highest potential impact in
reducing risks to all pollinators. These measures were developed in a manner intended to
preserve the majority of pest management utility, while also considering risk reductions for bees.
EPA reached out to a variety of stakeholders while developing the mitigation strategy in order to
gain a better grasp of growing practices and potential benefits. As part of its assessments of the
impacts of potential mitigation, EPA reviewed available information on the distribution of
application rates used by applicators, and this information contributed to identifying when
assumptions were made in the risk assessments regarding maximum rates may have
overestimated certain risks. These analyses also allowed the EPA to determine where targeted
rate reductions would decrease overall potential risks, while minimizing potential impacts to
users. Proposed risk mitigation measures were identified by evaluating each neonicotinoid active
ingredient and each use scenario for each crop individually, to determine the best path forward.
Overall, EPA is proposing addressing risk posed by current registered uses of imidacloprid uses
through the following risk mitigation measures:
• Cancel residential spray applications to turf, on-farm seed treatment (of canola, millet,
and wheat), and use on bulb vegetables;
• Require additional PPE;
• Reduce maximum application rates or restricting applications during pre-bloom and/or
bloom, targeting certain uses with potentially higher pollinator risks and lower benefits;
• Preserve the current restrictions for application at-bloom;
• Require advisory language for residential ornamental uses;
• Apply targeted application rate reductions for higher risk uses;
• Require additional spray drift and runoff reduction label language; and,
• Promote voluntary stewardship efforts to encourage employment of best management
practices, education, and outreach to applicators and beekeepers.
In selecting appropriate mitigation, EPA considered both the risks and benefits of imidacloprid
use. Due to the potential impact to growers' ability to address certain critical pest issues, the
agency did not propose risk mitigation on several uses, including citrus and grapes. For citrus
crops, the neonicotinoids are a key element in programs to control the ACP, an invasive pest that
transmits HLB, a devastating and incurable disease. In grapes, the neonicotinoids are used
similarly to combat sharpshooters which vector Pierce's Disease, a fatal bacterial disease for
grapes that can result in 100% yield loss. For other uses where mitigation was proposed, the
mitigation does not completely eliminate all risks of concern from the use of imidacloprid,
however does reduce overall risk and/or exposure. The agency finds the remaining risks to be
reasonable under FIFRA given the benefits of the use of imidacloprid. The EPA is also
proposing label changes to address general labeling improvements for all imidacloprid products.
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1. Cancellation of Uses
The agency is proposing cancellation of imidacloprid residential spray applications to turf. This
cancellation would eliminate risks of concern to both children and adults from the residential turf
use. Although this use has potentially high benefits to homeowners, EPA is required to address
non-occupational residential risks of concern under FQPA to ensure, "reasonable certainty that
no harm will result from aggregate exposure" from each pesticide from dietary or other sources
such as food, drinking water, and residential uses. Therefore, cancellation of the residential turf
use is necessary and is being proposed.
The agency is also proposing cancellation of imidacloprid use on bulb vegetables to mitigate
risks of concern to aquatic invertebrates. The highest risk estimates to aquatic invertebrates from
bulb vegetable use were up to an RQ of 556. A benefits assessment was conducted for this use
which showed limited usage of neonicotinoids, with an average of approximately 2,000 lbs.
applied annually and a percent crop treated of 2-3% for imidacloprid. Although the benefits
assessment noted that there were some benefits of neonicotinoids to target thrips, effective
alternatives to the neonicotinoids remain available for use on bulbs. Cancellation of this use
would also eliminate the risks identified for birds from foliar use of bulbs. In consideration of the
potential risks and the relatively low expected benefits, EPA is proposing cancellation of this
use.
2. Prohibition of On-farm Seed Treatment for Canola, Millet, and Wheat
As noted in Section III.A.l. of this PID, risks of concern have been identified for occupational
handlers for the use on canola, millet, and wheat via on-farm seed treatment activities. Even with
the maximum PPE (double layer of clothing, gloves, and an elastomeric half-mask respirator)
required for these uses, MOEs ranged from 2 - 25, (LOC= 100). To address potential
occupational risk concerns for workers involved in on-farm seed treatments of canola, millet, and
wheat using imidacloprid, EPA is proposing prohibiting use of on-farm treatment facilities for
these crops, and a requirement that treatment be conducted in commercial seed treatment
facilities only. EPA is proposing that all imidacloprid products registered for canola, millet, and
wheat seed treatment uses must include the following statement:
• "Must be applied in commercial seed treatment facilities only."
The aggregate impacts of this prohibition are uncertain because data on the extent of on-farm
treatment of canola, millet, and wheat seed are unknown.
3. Personal Protection Equipment
Human health risks of concern were identified for several registered agricultural, seed treatment
and liquid/foliar citrus handgun spray application use scenarios. EPA is proposing to mitigate
these risks through cancellation of certain uses, where necessary, and adding requirements for
Personal Protection Equipment (PPE) such as gloves, along with requiring certain applications
take place in commercial seed treatment facilities. With cooperation from stakeholders there was
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mutual agreement on the proposed label changes that would significantly reduce, and eliminate
in many scenarios, risks of concern to workers.
Most occupational handler risk estimates were not of concern with current baseline attire or with
personal protective equipment, however, several scenarios for workers performing activities
related to: on-farm seed treatment to barley, cotton, and citrus were of concern. As stated in
Section III. 1 of this PID, there were several potential risks of concern to occupational handlers,
including, short- and intermediate-term combined dermal and inhalation scenarios for barley and
cotton seed treatment use and citrus handgun application. MOEs for seed treatment uses included
barley and cotton, both with an MOE of 39 (LOC=100) with the current label-required single
layer clothing and gloves. The agency is therefore proposing adding double-layer clothing and
gloves for all handlers of imidacloprid barley and cotton on-farm seed treatments. The MOE for
the liquid/foliar handgun application use on citrus was 58 without the current label language
which does not require gloves. With the addition of single-layer gloves the MOE would be 160
and not of concern. The agency does not anticipate any risks of concern to handlers of
imidacloprid with the addition of this risk mitigation.
Therefore, to mitigate potential dermal and/or inhalation risks to handlers, the agency is
proposing requiring double-layer clothing and gloves for certain uses.
• Proposed uses to add requirement for double-layer clothing and gloves:
o Barley - on-farm seed treatment use
o Cotton - on-farm seed treatment use
• Proposed uses to add requirement for gloves:
o Citrus - liquid/foliar handgun application
In addition, the agency is proposing to update the glove statements currently on labels to be
consistent with the Label Review Manual10. The proposed new language does not fundamentally
change the personal protective equipment that workers need to use, and therefore should impose
no impacts on users. With cooperation from stakeholders, there was mutual agreement on the
proposed label changes that would significantly reduce, and eliminate in many scenarios, risks of
concern to workers.
4. Application Rate Reductions
Ecological risks of concern were identified for terrestrial and aquatic invertebrates as well as to
birds and mammals, described in more detail in the draft risk assessments. To help mitigate these
risks, EPA is proposing the following reductions in the maximum allowable annual application
rates for foliar and soil applications of imidacloprid products.
10 https://www.epa.gov/pesticide-registratloti/label-review-mannal
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Table 1. Proposed Maximum Annual Application Rates for Imidacloprid
Crop/Crop (Jroup
Current Rale (M:i\. Annual)
Proposed Rale (M;i\. Annual)
Berries and small fruits (non-
Foliar and soil: 0.50 lbs.
Maximum combined annual
grapes)
AI/A/yr
application rate for any berries
regardless of formulation type should
not exceed 0.40 lbs. AI/A/yr.
Brassica/Cole
Foliar: 0.23 lbs. AI/A/yr
Foliar: 0.20 lbs. AI/A/yr
Leafy Vegetables
Foliar: 0.23 lbs. AI/A/yr
Foliar: 0.20 lbs. AI/A/yr
Fruiting Vegetables
Foliar: 0.23 lbs. AI/A/yr
Foliar: 0.20 lbs. AI/A/yr
Root and tuber (not including
potato)
Foliar: 0.12 lbs. AI/A/yr
Soil: 0.38 lbs. AI/A/yr
Foliar: 0.10 lbs. AI/A/yr
Soil: 0.31 lbs. AI/A/yr
Legumes (not including
soybeans or peanuts)
Foliar: 0.13 lbs. AI/A
Foliar: 0.11 lbs. AI/A
Peanuts
Foliar: 0.13 lbs. AI/A
Foliar: 0.12 lbs. AI/A
Stone Fruit
Foliar: 0.50 lbs. AI/A
Foliar: 0.40 lbs. AI/A
Soil: 0.38 lbs. AI/A
Soil: 0.34 lbs. AI/A
Pome Fruit
Foliar: 0.50 lbs. AI/A
Foliar: 0.40 lbs. AI/A
Tree Nuts
Foliar: 0.36 lbs. AI/A
Foliar: to 0.30 lbs. AI/A
Soil: 0.50 lbs. AI/A
Soil: 0.36 lbs. AI/A
Cotton
Maximum combined annual
Maximum combined annual
application rate regardless of
formulation type: 0.50 lbs.
AI/A
application rate regardless of
formulation type: 0.37 lbs. AI/A
Turf
Foliar and soil: 0.40 lbs. AI/A
Foliar and soil: 0.30 lbs. AI/A.
Production/Commercial
Foliar and soil: 0.40 lbs. AI/A
Foliar and soil: 0.30 lbs. AI/A
Ornamentals
Application rate reductions are being proposed for several uses in order to reduce risks to both
bees and aquatic invertebrates. For pollinators, these rate reductions focus on certain crops with
the highest potential reduction of risks to bees. For bees and aquatic invertebrates, measured rate
reductions are a part of a multi-faceted approach to reducing overall exposure. The additional
approaches include spray drift and runoff reduction language, current application timing
restrictions, and pesticide education and outreach efforts. The goal of these proposed maximum
annual application rate reductions is to reduce the total environmental loading of imidacloprid
resulting from the various uses specified, while still providing growers with the ability to use
these tools as an effective means of pest control.
As part of the assessments of the benefits for the neonicotinoids, EPA also assessed the impacts
of potential mitigation, including the effect of reducing rates. This information was critical in
identifying sites and rates where rate reductions would achieve the greatest reduction in risk
while minimizing the potential impacts on users of imidacloprid. Although these proposed rate
reductions do not eliminate all risks, they are expected to contribute to reducing risk overall. The
benefits of these uses outweigh the remaining reduced risks of concern.
Berries and small fruits (non-grape)
The berries and small fruits crop group includes crops such as, strawberries, cranberry,
caneberry, and other berries and small fruit for which benefits and impacts have not been
assessed by the agency. EPA is proposing reducing the current maximum annual application rate
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of 0.5 lbs. AI/A, to not exceed a combined annual application rate of 0.40 lbs. AI/A/yr for any
berries regardless of formulation type. This mitigation is being proposed to address both
pollinator and aquatic invertebrate risks.
Risks from the berries and small fruits category were considered in the category, strongest
evidence of potential pollinator risk pre-bloom, in the agency's bee risk assessment. Both acute
and chronic risks of concern were identified to aquatic invertebrates with risk estimates up to an
RQ of 172. In addition to addressing risks of concern to bees, rate reductions also help reduce
potential aquatic invertebrate risk. Available data indicates that 90% of blueberry acres were
treated at 0.20 lbs. AI/A/year or less and the other 10% are treated at the higher 0.48 lbs
AVA/year rate. The average annual application rate for imidacloprid is 0.11 lbs. AI/A on
caneberries and 0.42 lbs. AI/A on strawberry, therefore for cases like caneberries, limited
impacts of the proposed mitigation are expected. However, it is uncertain whether there may be
greater impacts to use of imidacloprid on strawberries. The agency does not have information on
application rates for cranberry and blueberry and therefore the potential impacts of this
mitigation for those crops could not be assessed.
Brassica/Cole
For the brassica/cole crop group, which includes broccoli, EPA is proposing reducing the current
maximum annual application rate from 0.23 lbs. AI/A to 0.20 lbs. AI/A annually for foliar
applications. This rate reduction is targeted at reducing potential risk to aquatic invertebrates and
represents a reduction in the foliar rate to align closer with the average rate.
Potential risk to aquatic invertebrates was noted for both foliar and soil applications of
imidacloprid to brassica/cole, with RQs up to 680 with the highest risk identified for foliar use.
Benefits were considered to be high for imidacloprid's use on brassica/cole crops, with PCT's
ranging from 10 - 67%. Imidacloprid is particularly important to broccoli growers for general
control whitefly in brassica. The average annual application rates of imidacloprid applied
nationally to brassica/cole is 0.206 lbs. AI/A, slightly above the proposed rate. Potential impacts
to growers from this mitigation could vary. Data show that over 25% of the brassica and leafy
vegetable acres treated with imidacloprid utilize annual application rates of 0.304 lbs AI/A/year,
but this figure includes soil applications. Nearly 40% of the vegetable acres treated with
imidacloprid are treated at rates above 0.20 lbs AI/A/year. Thus, there are likely some situations
where growers make multiple applications of imidacloprid and would have to use an alternative
insecticide or insecticides for one of those applications.
Leafy vegetables
For the leafy vegetables, EPA is proposing to reduce the current maximum annual foliar
application rate from 0.23 lbs. AI/A to 0.20 lbs. AI/A. This rate reduction is targeted at reducing
potential risk to aquatic invertebrates only and represents a reduction in rates to align closer with
the average rate.
Potential risk to aquatic invertebrates was noted for both foliar and soil applications of
imidacloprid to leafy vegetables, with RQs up to 989 with the highest risk identified for foliar
use. The benefits were considered to be high for imidacloprid's use on leafy vegetables with
PCTs ranging from 33 - 74%. Imidacloprid is particularly important to lettuce growers to
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combat contamination issues at harvest. The average annual rate for imidacloprid to leafy
vegetables is 0.206 lbs. AI/A, just above the proposed rate. Potential impacts to growers from
this mitigation could vary. Data show that over 25% of the brassica and leafy vegetable acres
treated with imidacloprid utilize annual application rates of 0.304 lbs AI/A/year, but this figure
accounts includes soil applications. Nearly 40% of the vegetable acres treated with imidacloprid
are treated at rates above 0.20 lbs AVA/year. Thus, there are likely some situations where
growers make multiple applications of imidacloprid and would have to use an alternative
insecticide or insecticides for one of those applications.
Fruiting Vegetables
For fruiting vegetables, EPA is proposing reducing the current maximum annual foliar
application rate from 0.23 lbs. AI/A to 0.20 lbs. AI/A. This rate reduction is targeted at reducing
potential risk to aquatic invertebrates.
Potential risk to aquatic invertebrates was noted for both foliar and soil applications of
imidacloprid to fruiting vegetables, with RQs ranging up to 768 with the highest risk identified
for foliar use. Imidacloprid plays an important role in early season crop protection in carrots, and
based on usage on potato, it is likely important for use on other root and tubers. The PCT is 23%
for carrots and is primarily applied by chemigation. The average annual application rate for
imidacloprid on carrots is 0.277 lb AI/A/year and around 90% of acres are treated at rates of
0.304 lb AI/A/year or more. 74% of the treated carrot acres are treated at a single application rate
of 0.304 lb AI/A or more. EPA would expect a decrease in product performance at the lower
rate. Foliar applications are less important in carrots; however, they may be a valuable method
for other root and tuber crops. However, based on the magnitude of the risk exceedance for
carrots, a rate reduction is being proposed.
Root and tuber (not including potato)
For the root and tuber crop group (not including potato), EPA is proposing reducing the current
maximum annual foliar application rate from 0.12 lbs. AI/A to 0.10 lbs. AI/A and the maximum
annual soil application rate from 0.38 to 0.31. These rate reductions are targeted at reducing
potential risk to aquatic invertebrates.
Potential risk to aquatic invertebrates was noted for both foliar and soil applications from root
and tuber use, with foliar RQs ranging up to 2130, and soil RQs up to 998. Benefits were
considered moderate for imidacloprid's use on root and tubers, with PCTs as high as 23%.
Imidacloprid is particularly important to carrot growers. The average annual rate for
imidacloprid on root and tuber is 0.277, however due to substantial aquatic invertebrate risk, a
rate reduction is being proposed.
Legumes (not including soybeans or peanuts)
For the legumes crop group (dry and succulent beans and peas, not including soybeans or
peanuts), EPA is proposing reducing the current maximum annual foliar application rate from
0.13 lbs. AI/A to 0.11 lbs. AI/A. This rate reduction is targeted at reducing potential risk to
aquatic invertebrates only and represents a reduction in the foliar rate to align closer with the
average rate.
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Potential risk to aquatic invertebrates was identified for both foliar applications of imidacloprid
to legumes (not including soybeans or peanuts), with RQs ranging up to 400. Benefits were
considered low for imidacloprid's use on legumes (not including soybeans or peanuts), with
PCTs ranging from 4 - 6%. The average annual rate for imidacloprid to this crop group is 0.087
lbs. AI/A, below the proposed rate so potential impacts to growers from this mitigation are
considered likely to be low.
Peanuts
For peanuts, EPA is proposing reducing the current maximum annual foliar application rate from
0.13 lbs. AI/A to 0.12 lbs. AI/A. This rate reduction is targeted at reducing potential risk to
aquatic invertebrates.
Potential risk to aquatic invertebrates was noted for foliar applications of imidacloprid to
peanuts, with RQs up to 149. Benefits were considered high for this use as it is the only
neonicotinoid registered for peanuts, however, the PCT was less than 1% with a total of 41,000
lbs. applied annually. This rate reduction is likely to have very low impacts to growers on current
usage, which is primarily soil applications prior to crop emergence.
Stone Fruit
For stone fruit, EPA is proposing reducing the current maximum soil annual application rate of
0.38 lbs. AI/A to 0.34 lbs. AI/A, and a reduction in the maximum foliar annual application rate
from 0.50 lbs. AI/A to 0.40. This mitigation is being proposed both for pollinator and aquatic
invertebrate risk.
Risks from stone fruit use were assigned the category, weakest evidence of potential pollinator
exceedances post-bloom, in the agency's bee risk assessment. The systemic fate properties of
imidacloprid contributed to risks of concern both after bloom and before harvest. Foliar RQs
ranged up to 824 on an acute basis and 2920 on a chronic basis. Aquatic invertebrate risk for
foliar applications ranged up to 330. Soil risks were identified for pollinators with RQs up to 11.
For soil application, the agency expects little impact on the growers from a 10% reduction in the
current maximum annual application rate as soil treatment to stone fruit is rare. For foliar
application, a 20% reduction in the current maximum annual application rate is likely to affect a
sizeable number of cherry acres. As discussed in Section III C, the agency's stone fruit
assessment focuses on cherries and peaches, because imidacloprid is little used on peaches, the
agency did not assess potential impacts to growers for peaches. Other neonicotinoid alternatives
are available for stone fruit however impacts to growers could vary.
Pome Fruit
For pome fruit, EPA is proposing reducing the current maximum foliar annual application rate of
0.50 lbs. AI/A to 0.40. This mitigation is being proposed both for pollinator and aquatic
invertebrate risks.
Risk from pome fruit use assigned the category, weakest evidence of potential pollinator risk
post-bloom, in the agency's bee risk assessment. The systemic fate properties of imidacloprid
contributed to risks of concern both after bloom and before harvest. Foliar adult honeybee RQs
ranged up to 7301. Aquatic invertebrate risk for foliar applications ranged up to 743. These risks
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of concern represent some of the greatest risks compared to other agricultural uses. Benefits are
considered high for pome fruit use of imidacloprid post-bloom and medium for pre- and at-
bloom usage. Other neonicotinoid alternatives are available for pome fruit however impacts to
growers is considered moderate.
Tree nut
For tree nuts, EPA is proposing reducing the current maximum soil annual application rate of
0.50 lbs. AI/A to 0.36 lbs. AI/A; and a reduction in the maximum foliar annual application rate
from 0.36 lbs. AI/A to 0.30. This mitigation is being proposed both for pollinator and aquatic
invertebrate risks.
Risks from tree nut use were assigned the category moderate category of evidence for pollinator
risk from soil applications post-bloom in the agency's bee risk assessment, and aquatic risk from
primarily foliar usage. Adult honeybee RQs ranged up to 14. Aquatic invertebrate risks ranged
up to 433. The proposed soil rate was based on a safety finding for current tolerances of no
greater than 0.36 lbs. AI/A per year, while the proposed foliar rate was below this requirement.
These rate reductions are expected to have low impacts on current usage because, across all
application methods, around 5-10% of acres are treated at rates greater than 0.30 lbs. AH A/year.
Cotton
For cotton, EPA is proposing reducing the current maximum combined rate of 0.50 lbs. AI/A
regardless of formulation type and reducing it to 0.37 lbs. AI/A applied annually. This mitigation
is being proposed for pollinator risk.
Potential risks from cotton combined foliar and soil use was considered under the strongest
category of evidence for pollinator risk. Soil adult honeybee RQs ranged reached 2.6 on an acute
basis and 9.3 on a chronic basis to adults, while foliar adult honeybee RQs reached up to 494 on
an acute basis and 1752 chronic. Cotton is considered one of the major drivers of potential
pollinator risk. Imidacloprid is considered highly beneficial to cotton growers throughout the
growing season for a variety of pests.
Available usage data show that the average annual application rate is 0.151 lbs. AI/A per year
with less than 3% of acres treated with rates of 0.37 lbs. AI/A annually or more. The majority of
growers were found to apply imidacloprid to cotton at an average of less than 0.3 lbs. AI/A
annually, well below the proposed annual rate of 0.37 lbs. AI/A. Affected users may have to
switch to alternative insecticides or mix additional insecticides with imidacloprid to maintain
pest control. With consideration of current usage and typical rates, these rate reductions are
considered to have potentially low to medium impacts to users.
Turf
For turf, EPA is proposing reducing the current maximum annual foliar and soil application rate
from 0.40 lbs. AI/A to 0.30. This rate reduction is targeted at reducing potential risk to aquatic
invertebrates.
Potential risk to aquatic invertebrates was noted for applications of imidacloprid from turf, with
RQs ranging up to 236. Risk to bees assigned the category, moderate evidence of potential
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pollinator risk, in the agency's bee risk assessment. Benefits were considered high for this use
for imidacloprid, as it accounts for 75% of turf treated with neonicotinoids. Other than the
available 2014 Aglnfomatics report and review, current usage data was limited. This rate
reduction is considered to potentially have moderate impacts on usage.
Production and Commercial Ornamentals
For production and commercial ornamentals, EPA is proposing reducing the current maximum
annual foliar and soil application rate from 0.40 lbs. AI/A to 0.30. This rate reduction is targeted
at reducing potential risk to pollinators and aquatic invertebrates (nursery only). These rate
reductions apply to ornamental ground cover, ornamental trees, forestry, ornamental woody
shrubs and vines, and outdoor greenhouse/nursery. This risk mitigation does not include indoor
commercial nursery, Christmas trees, greenhouse uses, or forestry use on public land and
quarantine application by USD A.
Potential risks from use on ornamentals assigned the category, strongest evidence of potential
pollinator risk, in the agency's bee risk assessment. Risk to aquatic invertebrates were identified,
with RQs ranging up to 1020. Benefits were considered high for this use, as 75% of
neonicotinoid usage on ornamentals is with imidacloprid. Other than the available 2014
Aglnfomatics report and review, usage data was limited. This rate reduction is considered to
have potentially moderate impacts on current usage.
5. Crop Stage Restrictions
As noted in section four, risks were identified for several taxa described in the draft risk
assessments. Crop stage restrictions can limit exposure during critical periods in the growing
season when exposures to pollinators are more likely to occur. In its final bee risk assessment,
the agency analyzed a large volume of scientific data assessing residues of neonicotinoids in
pollen and nectar overtime. Through this analysis the agency calculated pre-bloom intervals to
determine at what stage in the growing season risk exceedances went above the level of concern.
By selecting application restrictions based on crop stage, the agency expects potential exposure
can be significantly reduced. These proposed restrictions were preferable only in crops with
distinct phenological stages which were easily identifiable by growers.
Table 2. Proposed Crop St
age-based application Restrictions for Imidacloprid
Crop/Crop (Jroup
Proposed Risk Mili»;ition
Fruiting Vegetables
For both foliar and soil applications: prohibit application after the
appearance of the initial flower buds until flowering is complete and all
petals have fallen off.
For tomatoes, peppers, chili peppers and okra only: Do not apply after 5
days after planting or transplanting regardless of application method.
Cucurbits
For both foliar and soil applications: prohibit use from vining to harvest
or after the emergence of the first true (non-cotyledon) leaf
Tropical and Subtropical
Fruit (avocado, banana,
dates, and olives only)
For foliar applications: prohibit foliar application pre-bloom until after
flowering is complete and all petals have fallen off; and
For soil applications: prohibit post-bloom application.
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Fruiting Vegetables
For the fruiting vegetables crop group, EPA is proposing a crop stage restriction for both foliar
and soil applications, to prohibit application after the appearance of the initial flower buds until
flowering is complete and all petals have fallen off. For tomatoes, peppers, chili peppers and
okra, EPA is proposing to prohibit application after 5 days after planting or transplanting
regardless of application method for all crops in the crop group.
Potential risk to pollinators was assigned the category, strongest evidence of potential pollinator
risk, in the agency's bee risk assessment for foliar and soil uses of pollinator attractive fruiting
vegetables. Benefits were considered high for imidacloprid's use on fruiting vegetables, though
PCTs ranged from 32% to 65%. Imidacloprid is considered particularly important to tomato
growers. Applications after crop emergence or transplanting account for around two-thirds of the
treated acres of peppers and tomato acres. Imidacloprid targets season-long pests. Thrips,
stinkbug and pepper weevil can target fruit directly and viral diseases vectored by aphids and
whitefly can seriously impact the development, quality and/or yield of the harvested fruit. The
proposed changes are expected to potentially impact growers.
Cucurbits
For cucurbits, EPA is proposing a crop stage restriction for both foliar and soil applications, to
prohibit use from vining to harvest or after the emergence of the first true (non-cotyledon) leaf.
The applicator would have a choice to either utilize either crop stage description [e.g., vining to
harvest or first true (non-cotyledon) leaf]. The agency encourages input from stakeholders
regarding the best identifier for crop stage.
Risk to pollinators was assigned the category, strongest evidence of potential pollinator risk, in
the agency's bee risk assessment for cucurbit soil uses. Based on available residue data,
imidacloprid remained in the plant matrices at high levels for months after application. Residues
exceeded the lowest observed effect concentration (LOEC) at 65 days after application for foliar
applications and 67 days for soil applications. Available benefits information identified
imidacloprid usage to most commonly occur prior to crop emergence, therefore, a restriction
from vining to harvest is likely to not significantly impact current usage.
Tropical and Subtropical Fruit
For avocado, banana, dates, and olives, EPA is proposing a crop stage restriction for foliar labels
to prohibit foliar application from pre-bloom until after flowering is complete and all petals have
fallen off; and to prohibit post-bloom application for soil applications. No mitigation is proposed
for other fruit trees in this crop group.
Risk to pollinators was assigned the category, weakest evidence of potential pollinator risk, in
the agency's bee risk assessment for foliar and soil post-bloom applications. Risk mitigation is
being proposed on crops in this group considered to have higher usage and to be pollinator
attractive, however, no risk mitigation is being proposed for lower acreage or non-bee attractive
crops. An exception is provided for pomegranate as well, due to available usage data showing
imidacloprid use on pomegranate as particularly beneficial. From the information available on
avocado, dates, and olives, the agency anticipates low impacts to users. California accounts for
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about 90% of total U.S. acreage of these crops and, based on data from California Pesticide Use
Reports, usage of imidacloprid is rare on avocado, dates, and olives. EPA is specifically
requesting public comments to better understand potential impacts on banana production.
6. Residential Ornamental Advisory
For application to ornamental plants, the agency identified significant risks of concern. Potential
risks from use on ornamentals was assigned the category, strongest evidence of potential
pollinator risk, in the agency's bee risk assessment. Risk to aquatic invertebrates was also
identified, with RQs ranging up to 1020. Benefits were considered high for this use, as 75% of
neonicotinoid usage on ornamentals is with imidacloprid. However, other than the available 2014
Aglnfomatics report and review, usage data was limited. The agency is proposing adding
language to residential labels advising that ornamental products are, "Intended for use by
professional applicators". This is due to the high risks of concern, the potential extent of
exposure, particularly to bees, and to decrease the likelihood of misapplication or overapplication
where significant risks of concern have been identified for these uses.
7. Label Language Improvements
EPA is proposing several advisory label language changes intended to better inform and/or
discourage the applicator from creating exposures that may lead to increased risks of concern.
This includes updates to the current advisory bee language, water soluble packaging, and
language to better clarify whether products are for indoor or outdoor use. For more information,
please see Appendix B.
The agency is also proposing revising the PHI to 7-days on the Admire® 2F label to reflect other
pomegranate labels, based on information listed in the 2008 scoping document (PP# 5E6920, J.
Tyler, 14-JUN-2006; D322834).
Risks of concern were identified to birds and small mammals associated with seeds that are
treated with imidacloprid for which EPA is proposing additional advisory label language,
encouraging the promotion of Best Management Practices (BMPs) and education programs to
help inform users about the importance of picking up spilled seed in order to reduce exposure to
birds and mammals. The agency's understanding of these risks includes characterization that
indicate only a portion of birds and mammals are likely to be impacted. Risk mitigation measures
were considered with the understanding of the high benefits associated with seed treatment uses,
which through their use, have the potential to reduce overall neonicotinoid exposure and offer a
lower overall ecological risk compared to foliar uses.
8. Restrictions to Poultry House Uses
Due to the persistence of neonicotinoids in the environment, potential risks of concern to
honeybees were also identified for imidacloprid from use on poultry litter in broiler houses at the
maximum annual application rate. Once applied, the litter can be applied as a fertilizer on
agricultural fields, contributing to ecological exposure. EPA is proposing to reduce risk from this
use by reducing the number of whole house applications allowed annually for imidacloprid.
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In order to reduce exposure to pollinators, EPA is proposing that all imidacloprid products
registered for poultry house uses must include the following statements:
• "Limit applications to one whole house treatment and 5 perimeter (partial house)
treatments per year."
• "Do not apply to more than 30,000 sq. ft. per year per house."
The goal of these proposed statements is to reduce the total environmental loading of
imidacloprid resulting from poultry house uses. Limiting both the number and square footage of
allowable poultry house treatments per year will limit the amount of imidacloprid entering the
environment when treated poultry litter is removed from poultry houses and used as a soil
amendment in agricultural fields. The proposed mitigation retains the use of imidacloprid for
poultry producers, recognizing its importance in treating for darkling beetles and other poultry
house pests.
9. Spray Drift and Runoff Reduction
EPA is proposing label changes to reduce off-target spray drift and establish a baseline level of
protection against spray drift that is consistent across all imidacloprid products. Reducing spray
drift will reduce the extent of environmental exposure and risk to non-target plants and animals.
Although the agency is not making a complete endangered species finding at this time, these
label changes are expected to reduce the extent of exposure and may reduce risk to listed species
whose range and/or critical habitat co-occur with the use of imidacloprid.
The agency is proposing the following spray drift mitigation language be included on all
imidacloprid product labels. The proposed spray drift language is intended to be mandatory,
enforceable statements and supersede any existing language already on product labels (either
advisory or mandatory) covering the same topics. The agency is providing recommendations
which allow imidacloprid registrants to standardize all advisory language on imidacloprid
product labels. Registrants must ensure that any existing advisory language left on labels does
not contradict or modify the new mandatory spray drift statements proposed in this proposed
interim decision once effective.
These mandatory spray drift mitigation measures are proposed for aerial applications for all
products delivered via liquid spray:
• Applicators must not spray during temperature inversions.
• For aerial applications, do not apply when wind speeds exceed 15 mph at the application
site. If the windspeed is greater than 10 mph, the boom length must be 65% or less of the
wingspan for fixed wing aircraft and 75% or less of the rotor diameter for helicopters.
Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing aircraft
and 90% or less of the rotor diameter for helicopters.
• For aerial applicators, if the windspeed is 10 miles per hour or less, applicators must use
'/2 swath displacement upwind at the downwind edge of the field. When the windspeed is
between 11-15 miles per hour, applicators must use 3/4 swath displacement upwind at the
downwind edge of the field.
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• For aerial applications, the release height must be no higher than 10 feet from the top of
the crop canopy or ground, unless a greater application height is required for pilot safety.
• Specify spray droplet size of medium or coarser (ASABE S572.1)
• Do not apply by air within 150 feet of lakes, reservoirs, rivers, permanent streams,
marshes or natural ponds, estuaries and commercial fish farm ponds.
These mandatory spray drift mitigation measures are proposed for ground applications delivered
via liquid spray:
• Applicators must not spray during temperature inversions.
• Do not apply when wind speeds exceed 15 mph at the application site.
• User must only apply with the release height recommended by the manufacturer, but no
more than 4 feet above the ground or crop canopy.
• Specify spray droplet size of medium or coarser (ASABE S572.1)
• For air blast applications, nozzles directed out of the orchard must be turned off in the
outer row.
• For air blast applications, applications must be directed into the canopy foliage.
• Do not apply by ground within 25 feet of lakes, reservoirs, rivers, permanent streams,
marshes or natural ponds, estuaries and commercial fish farm ponds.
To reduce the amount of imidacloprid that can enter waterbodies from runoff, EPA is proposing
a vegetative filter strip (VFS) requirement for all imidacloprid agricultural products of 10 feet.
Currently some imidacloprid product labels already have a VFS requirement of 10 feet on labels.
VFS are intended to reduce sediment loads to adjacent water bodies, and also show some
efficacy in reducing runoff volume as well. As a consequence, they may have some utility in
reducing movement of pesticides, particularly those bound to sediments into natural waters.
They are somewhat expensive to implement and maintain, and they must be maintained, or they
will lose efficacy and channelized flow across the VFS will develop after a few years. VFS are
most effective at removing non-source point pollutants (e.g., pesticides) from runoff water
sources. However, the effectiveness of a VFS is influenced by various land management
practices (e.g., flood and furrow irrigated fields, etc.) which may impact their utility. The Agency
has considered several additional sources of research which contextualize the benefits of VFS
and has determined that proposing the use of VFS is appropriate mitigation to reduce
imidacloprid residues in aquatic habitats. EPA is not proposing a VFS requirement in Western
irrigated agriculture because a VFS would be more expensive to maintain, and runoff is less
likely. In the west, areas where agriculture is irrigated would likely require irrigation to maintain
a VFS, and on fields where water is managed carefully there is less likely to be runoff and
erosion into a waterbody.
The following proposed mitigation measure applies to all agricultural uses of imidacloprid. This
proposed mitigation requirement is separate and in addition to the spray drift buffer zones
described above; spray drift buffer zones are still proposed to be required if a vegetated filter
strip is present. The proposed vegetative filter strip requirement reads as follows:
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• Construct and maintain a vegetative filter strip, according to the width specified below, of
grass or other permanent vegetation between the field edge and nearby down gradient
aquatic habitat (e.g., lakes, reservoirs, rivers, permanent streams, marshes, natural ponds,
estuaries, commercial fish farm ponds).
o Only apply products onto fields where a maintained vegetative filter strip of at
least 10 feet exists between the field edge and where a down gradient aquatic
habitat exists. This minimum required width of 10 feet may be reduced under the
following conditions:
¦ Western irrigated agriculture is exempt from this requirement. Western
irrigated agriculture is defined as irrigated farmland in the following
states: WA, OR, CA, ID, NV, UT, AZ, MT, WY, CO, NM, and TX (west
of 1-35).
Impacts of Spray Drift and Runoff Mitigation
EPA examined a subset of labels from single AI products of imidacloprid (EPA Reg # 264-827,
34704-931). These labels represent more than 40% of all imidacloprid applied to agricultural
crops (MRD 2013-2017). This was not an exhaustive label review, but this was preformed to
have an idea of the spray drift statements currently on labels to determine if any of the changes
would lead to an impact to growers.
Wind Speed. Percent Usable Boom Length. Swath Displacement and Release Height (aerial
applications)
Labels reviewed have a wind speed restriction of 15 mph and the boom length must not exceed
75% of the wing span or rotor diameter. Therefore, there should be little impact when applications
are made when wind speed is 15 mph when applications are made with fixed wing aircraft.
Additionally, there would be increased percent usable boom length (90% or less) of the rotor
diameter for helicopters which could mean more area can be covered in less time. However, when
wind speeds are between 10 and 15 mph, applicators using fixed wing aircraft, will need to reduce
the swath width. This will lead to more passes being made and will cause applications to take
longer which is likely to be more expensive. Another option would be to use a different, more
expensive chemical that does not have this restriction.
Labels reviewed do not address swath displacement based upon wind speed. The agency has not
assessed the impacts of windspeed restrictions for aerial applications and the requirement of a V2
or 3/4 swath displacement upwind at the downwind edge of the field. The agency invites
comments if this mitigation would impact growers.
Labels reviewed currently require applicators to release imidacloprid at a height no higher than
10 feet from the top of the crop canopy or ground, unless a greater application height is required
for pilot safety. Therefore, the agency does not expect an impact for requiring this language as
mandatory for all imidacloprid labels.
Wind Speed and Release Heights (ground applications)
Labels reviewed have a mandatory wind speed restriction of 15-mph, and one of the labels
reviewed indicate wind speed restrictions do not apply to applications made in-furrow or below
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soil-level (EPA Reg # 264-827). Therefore, the agency does not anticipate an impact of a 15-
mph wind speed restriction.
Labels reviewed currently do not specify a release height for ground application. However,
previous analysis for release heights for most nozzles indicate a release height of 4ft should not
impact grower when making applications of imidacloprid.
Temperature Inversions (ground and aerial applications)
Labels reviewed have a mandatory language prohibiting applications during inversions;
therefore, the agency does not anticipate an impact in restricting applications during temperature
inversions. The agency notes that some applicators may make applications in the evening hours
to avoid spraying during the daytime to avoid making applications when pollinators are active.
Temperature inversions are generally considered to be more likely to occur a couple of hours
before and after sunset and sunrise. These growers would likely switch to a different active
ingredient that does not have this restriction.
Droplet Size (aerial and ground applications, excluding airblast sprayers)
The Agency is considering establishing a mandatory droplet size of medium to coarser for all
neonicotinoids to address the potential risks of neonicotinoids to terrestrial and aquatic
invertebrates. Components of applications, including droplet size, are complex, but essentially
insects need to come into contact with, or ingest, a lethal dose of insecticide to be effectively
controlled which requires proper coverage throughout the plant. Hypothetically, systemic
insecticides, like neonicotinoids, might control some insects with a larger droplet size due to the
systemic movement within the plant, but systemic activity alone does not mean effective control
will still occur. Buchholz and Nauen (2001)11 showed that the control from neonicotinoids was
more complex than an active ingredient being systemic, i.e., control was a "combination of
systemic and contact properties." The authors indicate that factors such as the cuticular
properties of leaves, metabolism and stage of insect (e.g., mobile versus quiescent stages), and
the physio-chemical properties of the insecticide contribute to the performance of neonicotinoids.
Furthermore, Basso et al. (2016)12 showed that contact with neonicotinoids was needed to
control insects on large plants compared with smaller plants, presumably due to poor
translocation in large plants.
The labels reviewed provide advisory language that suggests growers should apply with the
largest droplet that provides effective control. Generally, entomologists accept that good
coverage is required for maximum efficacy during an application and that fine droplets provide
better coverage than coarse droplets. BEAD expects that droplet size restrictions could decrease
the control of pests with contact neonicotinoids. If control was reduced, BEAD anticipates
growers would increase rates, make more frequent applications, and/or select alternative
products (pyrethroids, carbaryl, diflubenzuron, etc., depending on the target pest). Additionally,
growers may face financial impacts due to increased cost of applications and/or reduced yields or
11 Buchholz, A. and R. Nauen. 2001. Translocation and translaminar bioavailability of two neonicotinoid
insecticides after foliar application to cabbage and cotton. PestMgmt. Sci. 58: 10-16.
12 Basso, C.J., C.C. Kuss, O.H. de Castro Pias, D.S. Muraro, andL. Cutti. 2016. Neonicotinoid insecticide
systemicity in soybean plants and its effect on brown stink bugs. Pesq. Agropec. Trop., Goiania 46: 96-101.
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quality due to poor control. Furthermore, mandatory droplet size could lead to reduced rates
being successfully delivered to the target pest(s) via poor coverage and undermine resistance
management efforts.
Buffers (ground and aerial applications)
Labels reviewed prohibit applications within 25 feet (ground), or within 150 feet (aerially) of lakes;
reservoirs; rivers; permanent streams; marshes or natural ponds; estuaries and commercial fish
farm ponds. Therefore, the agency does not anticipate an impact with buffer requirements.
However, the agency did not assess this mitigation on a crop by crop basis or review labels for
specific crops that may be impacted by this mitigation. The impact of this mitigation can be highly
localized and depends on the size and shape of a field. Leaving an area untreated in a field can
harbor insects and serve as a source of re-infestation, requiring subsequent applications. If a grower
were using an imidacloprid product that does not currently have this restriction, the grower would
likely switch to a different chemical that does not have this restriction. These impacts will
disproportionally affect growers producing crops from small acreage fields.
Requirements for Air Blast Sprayers
Labels reviewed have mandatory language requiring that spray is only directed in the canopy, is
prohibited from going beyond the edge of the cultivated area and is directed inward, toward the
orchard/vineyard when treating the outer row. Therefore, the agency does not expect impacts
associated with the proposed mitigation.
Impacts of Vegetative Filter Strips
Labels reviewed require a 10-foot VFS. Therefore, the agency does not anticipate an impact with
VFS requirements. However, the agency did not assess this mitigation on a crop by crop basis or
review labels for specific crops that may be impacted by this mitigation. The impact of this
mitigation can be highly localized and depends on the size and shape of a field. In some situations,
VFS may require growers to remove land from production thus decreasing revenue. These impacts
will disproportionally affect growers producing crops from small acreage fields. If a grower were
using an imidacloprid product that does not currently have this restriction, the grower would likely
switch to a different chemical that does not have this restriction.
In addition to the drift reduction measures and VFS discussed above, EPA is proposing measures
to reduce the perimeter treatment area and increase label clarity and consistency, thus reducing
the overall amount of imidacloprid that enters waterbodies and outdoor drainage systems.
Specific measures are intended to ensure areas sprayed are permeable and less runoff-prone,
reduce offsite-drift to waterbodies, as well as to reduce the potential for overspraying. Although
potential risks to aquatic organisms are expected to remain after the implementation of the
measures, these proposed label changes are directionally correct with respect to reducing the
amount of environmental exposure. The following mandatory and advisory mitigation measures
for all imidacloprid outdoor residential and commercial use sites to reduce the amount of runoff
entering waterbodies and drainage systems:
• Band and perimeter treatment is limited to an area of application no more than T out x 2'
feet up maximum around buildings or structures.
• Spot treatment is application to limited areas on which insects are likely to occur, but
which will not be in contact with food or utensils and will not ordinarily be contacted by
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workers. These areas may occur on floors, walls, and bases or undersides of
equipment. For this purpose, a "spot treatment" will not exceed 2' x 1' square feet.
• Do not apply to impervious horizontal surfaces such as sidewalks, driveways, and patios
except as a spot or crack and crevice treatment.
• Do not apply to the point of runoff.
• Do not apply during rainfall.
• Avoid applying when rain is expected within 24 hours except when product requires
watering in.
Impacts of Mitigation Measures for Residential and Commercial Use Sites
The agency did not assess the impacts of runoff mitigation measures residential and commercial
use sites; however, the agency considers these measures are consistent with application practices.
The agency invites comments if this mitigation would impact applicators.
In addition to including the following spray drift restrictions on imidacloprid labels, all
references to volumetric mean diameter (VMD) information for spray droplets are proposed to
be removed from all imidacloprid labels where such information currently appears and to
establish label consistency by requiring standardized spray drift advisory language. The proposed
new language below, which cites American Society of Agricultural & Biological Engineers
(ASABE) S572.1, eliminates the need for VMD information.
10. Pesticide Resistance Management
Pesticide resistance occurs when genetic or behavioral changes enable a portion of a pest
population to tolerate or survive what would otherwise be lethal doses of a given pesticide. The
development of such resistance is influenced by a number of factors. One important factor is the
repeated use of pesticides with the same mode (or mechanism) of action. This practice kills
sensitive pest individuals but allows less susceptible ones in the targeted population to survive
and reproduce, thus increasing in numbers. These individuals will eventually be unaffected by
the repeated pesticide applications and may become a substantial portion of the pest population.
An alternative approach, recommended by resistance management experts as part of integrated
pest management (IPM) programs, is to use pesticides with different chemical modes (or
mechanisms) of action against the same target pest population. This approach may delay and/or
prevent the development of resistance to a particular mode (or mechanism) of action without
resorting to increased rates and frequency of application, possibly prolonging the useful life of
pesticides.
The EPA is proposing resistance-management labeling, as listed in Appendix B, for products
containing imidacloprid, in order to provide pesticide users with easy access to important
information to help maintain the effectiveness of useful pesticides. Additional information on the
EPA's guidance for resistance management can be found at the following website:
https://www.epa.gov/pesticide-registration/pm-2 guidance-pesticide-registrants-pesticide-
resi stan ce-management.
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B. Stewardship
In addition to establishing both advisory and compulsory language for product labels, EPA's
registration review provides an opportunity to inform stakeholders and the general public about
opportunities to minimize potential ecological risks and promote pollinator health more
generally. Beyond the mitigation measures proposed above, voluntary stewardship activities and
use of best management practices (BMPs) can be effective in further reducing pesticide exposure
to at risk taxa. Examples of these activities include:
• promoting the creation of additional pollinator habitat;
• improving pesticide users' understanding and adherence to label directions which advise
users on seed spill clean-clean up, reduction in drift/runoff, and minimizing exposure to
pollinators;
• promoting integrated pest management (IPM) solutions;
• encouraging growers to take care when planting treated seed to reduce the amount of
exposed seed; and,
• increasing awareness of potential impacts of pesticides through education (e.g., training
courses, pamphlets, workshops/conferences, and through tv, radio, social media and other
communication platforms).
Habitat loss is a significant issue with negative impacts on the health of bees. With access to a
healthy and diverse diet through a thriving habitat, bees may be better able to tolerate stressors
such as pests, disease, and exposure to pesticides. As a healthy diet is crucial to maintaining
flourishing pollinator populations, and the protection of pollinator habitat is not something that
can be directly addressed on a pesticide product label, EPA and other federal/state/tribal and
local government agencies and non-government organizations (NGOs) promote pollinator
habitat through active education and outreach programs. Helpful guidance on pollinator
protection can be found on the EPA's pollinator protection webpage13.
Users should take several precautions while using neonicotinoid products to minimize potential
exposure to pollinators. First, users should not apply neonicotinoids when bees and other
pollinators are actively foraging on pollinator-attractive plants during bloom. Secondly, users
should consider a pesticide's ability to drift to other non-target areas and be aware of the
presence of bee colonies or highly bee-attractive plants nearby an application site. With
applications to lawns, its beneficial to mow prior to applications. Although the cultivation and
protection of pollinator habitat is typically encouraged, in this case, taking steps to ensure a lawn
is mowed prior to neonicotinoid applications can reduce potential direct exposure for visiting
pollinators. Other things the public can do to minimize potential exposure of pollinators are
listed on EPA's, What You Can Do to Protect Honey Bees and Other Pollinators webpage14.
Treated seed is most likely to become available to birds and mammals through accidental spills,
excess unplanted seed on the edges of the field, shallow planted seed, and the improper disposal
13 https://www.epa.gov/poHinator-protection
14 https://www.epa.gov/poHinator-protection/what-yoii-can-do-protect-honey-bees-and-other-poHiiBtors
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of treated seed. An effective method to reduce exposure would be encouraging growers to take
additional care when planting treated seed to ensure any exposed seed is retrieved. The American
Seed Trade Organization has published a guide15 to help educate applicators on practices to help
reduce potential risks to the environment from seed treatments. The agency encourages public
and private participation in creating tools and fostering effective communication to help reach
applicators and educate them on practices that can reduce risks to the environment.
The technical registrants for the neonicotinoids, including Bayer, BASF, Mitsui, Syngenta, and
Valent, coordinated to develop a voluntary proposal to promote product stewardship for their
product seed treatments and applications in agricultural crops, production and landscape
ornamental plants, turfgrass and pest-management setting (structural, commercial and
residential). Their proposal includes a summary of the current neonicotinoid stewardship
program, as well as their proposal for an enhanced registrant-initiated stewardship program for
expansion and amplification of stewardship efforts. This document, Neonicotinoid Stewardship
Program - Current Summary and Proposal, is included in the public docket for each of the
neonicotinoids along with their PIDs.
The agency encourages strong pollinator protection stewardship in both the public and private
sector. EPA will continue to work with its partners at the federal, state, tribal, and local levels,
along with non-governmental organizations to promote pollinator protection, education, and
outreach. This includes coordinating with states and tribes on pollinator protection plans {i.e.;
managed pollinator protection plans), coordinating with stakeholders on extension of, and
education around, existing BMPs, and continued education and outreach to the public on
pollinator protection. In addition, the agency plans on continuing conversations with the
registrants on the Neonicotinoid Stewardship Program.
C. Tolerance Actions
The agency proposes increasing the tolerances for residues of imidacloprid on citrus fruits and
coffee to harmonize with Canada and Codex MRLs. Tolerances are proposed to be revoked for
apple, okra, pecan, pistachio, watercress, watercress (upland), and vegetable legume group 6.
Tolerances are proposed to be established for celtuce, fennel/florence/fresh leaves and stalk,
kohlrabi, and soybean vegetable. Additionally, EPA is proposing eliminating trailing zeros listed
in tolerances consistent with agency policy. All proposed tolerance revisions for imidacloprid are
listed in Section III. A 3 for more details. The agency will use its FFDCA rulemaking authority to
undertake needed tolerances changes.
D. Proposed Interim Registration Review Decision
In accordance with 40 CFR §§ 155.56 and 155.58, the agency is issuing this PID. Except for the
Endocrine Disruptor Screening Program (EDSP) and the Endangered Species Act (ESA)
components of this case, the agency has made the following PID:
(1) no additional data are required at this time; and (2) changes to the affected registrations and
their labeling are needed at this time, as described in Section IV. A and Appendices A and B.
15 https://seed4reatment-guide.coni/
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In this PID, the agency is making no human health or environmental safety findings associated
with the EDSP screening of imidacloprid, nor is it making a complete endangered species
finding. Although the agency is not making a complete endangered species finding at this time,
the proposed mitigation described in this document is expected to reduce the extent of
environmental exposure and may reduce risk to listed species whose range and/or critical habitat
co-occur with the use of imidacloprid. The agency's final registration review decision for
imidacloprid will be dependent upon the result of the agency's ESA assessment and any needed
§ 7 consultation with the Services and an EDSP FFDCA § 408(p) determination.
E. Data Requirements
The agency does not anticipate calling-in additional data for the imidacloprid registration review
at this time.
V. NEXT STEPS AND TIMELINE
A. Proposed Interim Registration Review Decision
A Federal Register Notice will announce the availability of this PID for imidacloprid and will
allow a 60-day comment period on the PID. If there are no significant comments or additional
information submitted to the docket during the comment period that leads the agency to change
its PID, the EPA may issue an interim registration review decision for imidacloprid. However, a
final decision for imidacloprid may be issued without the agency having previously issued an
interim decision. A final decision on the imidacloprid registration review case will occur after:
(1) an EDSP FFDCA § 408(p) determination and (2) an endangered species determination under
the ESA and any needed § 7 consultation with the Services.
B. Implementation of Mitigation Measures
Once the Interim Registration Review Decision is issued, the imidacloprid registrants must
submit amended labels that include the label changes described in Appendix B. The revised
labels and registration amendments must be submitted to the agency for review within 60 days
following issuance of the Interim Registration Review Decision.
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Appendix A: Summary of Proposed Actions for Imidacloprid
Registration Review Case#: 7605
PC Code: 129099
Chemical Type: Insecticide
Chemical Family: Neonicotinoids
Mode of Action: Nicotinic acetylcholine receptor (NACHR) competitive modulators
Affected
Population(s)
Source of
Exposure
Route of Exposure
Duration of
Exposure
Potential Risk(s) of
Concern
Proposed Actions
Pollinators
Residues on
treated site
Ingestion and contact
Acute and
chronic
Acute and chronic
toxicity
• Reduce application rates
• Crop stage restrictions
• General other use restrictions
• Spray drift reduction
Occupational
Handlers
Aerial and
ground
application
Dermal and inhalation
Short and
intermediate
term
Portal of entry effects
• Require additional PPE (e.g.,
double layer clothing, gloves)
• Precautionary statements
• Prohibition of on-farm seed
treatments for canola, millet, and
wheat
Residential post-
application (adults
and children)
Ground
application
Dermal and inhalation
Short and
intermediate
term
Portal of entry effects
• Use deletion for residential spray
applications to turf
Aquatic
Invertebrates
Runoff from
treated sites
Ingestion and contact
Acute and
chronic
Acute and chronic
toxicity
• Reduce application rates
• Spray drift and runoff reduction
• Vegetative filter strips
• Use deletion for bulb vegetables
• Reduce perimeter treatment
applications
Birds and
Mammals
Residues on
ingested seeds
Dietary and ingestion
Acute and
chronic
Acute and chronic
toxicity
• Clean up spills of treated seeds
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Appendix B: Proposed Labeling Changes for Imidacloprid Products
Description
Proposed l.ahcl Language lor Imidacloprid Products
Placement on Label
Technical Products
Residential turf use
Delete residential spray use on turf.
Directions for Use
Foliar spray and soil drench
use on bulb vegetables
Delete foliar spray and soil drench use on bulb vegetables.
Directions for Use
I'lnri I so Products |
Mode/Mechanism of Action
Group Number
Note to registrant:
• Include the name of the ACTIVE INGREDIENT in the first column
• Include the word "GROUP" in the second column
• Include the MODE/MECHANISM OF ACTION CODE in the third column
(for herbicides this is the Mechanism of Action, for fungicides this is the FRAC
Code, and for insecticides this is the Primary Site of Action)
• Include the type of pesticide in the fourth column.
Front Panel, upper right
quadrant.
All text should be black,
bold face and all caps on a
white background, except
the mode of action code,
which should be white, bold
face and all caps on a black
background; all text and
columns should be
surrounded by a black
rectangle.
Imidacloprid
GROUP INSECTICIDE
Updated Gloves Statement
Update the gloves statements to be consistent with Chapter 10 of the Label Review
Manual. In particular, remove reference to specific categories in EPA's chemical-
resistance category selection chart and list the appropriate chemical-resistant glove types
to use.
In the Personal Protective
Equipment (PPE) within the
Precautionary Statements
and Agricultural Use
Requirements, if applicable
Additional PPE (double layer
clothes and gloves) for seed
treatments to barley and
cotton
"Applicators must wear two layers of clothing and chemical resistant gloves while
applying on-farm seed treatments to barley and cotton."
Personal Protective
Equipment (PPE) within the
Precautionary Statements
Additional PPE (gloves) for
liquid spray applications to
citrus by handgun
"Applicators must wear chemical resistant gloves for liquid spray applications by
handgun."
PPE within the
Precautionary Statements
Resistance-management
labeling statements for
insecticides and acaricides
Include resistance management label language for insecticides/acaricides from PRN
2017-1 (httDs://www.eDa.eov/t>esticide-reeistration/Desticide-reeistration-iiotices-year)
Directions for Use, prior to
directions for specific crops
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Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
Additional Required Labelling
Action
Applies to all products
delivered via liquid spray
applications
Remove information about volumetric mean diameter from all labels where such
information currently appears.
Directions for Use
Seed treatments to canola,
millet, and wheat
"Apply in a commercial seed treatment facility."
Directions for Use
Directions for mixing/loading
products packaged in water
soluble bags
Instructions for Introducing Water Soluble Packages Directly into Spray tanks:
"Soluble Packages (WSPs) are designed to dissolve in water. Agitation may be used, if
necessary, to help dissolve the WSP. Failure to follow handling and mixing instructions
can increase your exposure to the pesticide products in WSPs. WSPs, when used
properly, qualify as a closed mixing/loading system under the Agricultural Worker
Protection Standard [40 CFR 170.607(d)].
Handling Instructions
Follow these steps when handling pesticide products in WSPs.
1. Mix in spray tank only.
2. Handle the WSP in a manner that protects package from breakage and/or
unintended release of contents. If package is broken, put on PPE required for clean-up
and then continue with mixing instructions.
3. Keep the WSP in outer packaging until just before use.
4. Keep the WSP dry prior to adding to the spray tank.
5. Handle with dry gloves and according to the label instructions for PPE.
6. Keep the WSP intact. Do not cut or puncture the WSP.
7. Reseal the WSP outer packaging to protect any unused WSP(s).
Mixing Instructions
Follow the steps below when mixing this product, including if it is tank-mixed with
other pesticide products. If being tank-mixed, the mixing directions 1 through 9 below
take precedence over the mixing directions of the other tank mix products. WSPs may, in
some cases, be mixed with other pesticide products so long as the directions for use of all
the pesticide product components do not conflict. Do not tank-mix this product with
products that prohibit tank-mixing or have conflicting mixing directions.
Directions for Use for
mixing/loading WSP
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Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
1. If a basket or strainer is present in the tank hatch, remove prior to adding the
WSP to the tank.
2. Fill tank with water to approximately one-third to one-half of the desired final
volume of spray.
3. Stop adding water and stop any agitation.
4. Place intact/unopened WSP into the tank.
5. Do not spray water from a hose or fill pipe to break or dissolve the WSP.
6. Start mechanical and recirculation agitation from the bottom of tank without
using any overhead recirculation, if possible. If overhead recirculation cannot be turned
off, close the hatch before starting agitation.
7. Dissolving the WSP may take up to 5 minutes or longer, depending on water
temperature, water hardness and intensity of agitation.
8. Stop agitation before tank lid is opened.
9. Open the lid to the tank, exercising caution to avoid contact with dusts or spray
mix, to verify that the WSP has fully dissolved and the contents have been thoroughly
mixed into the solution.
10. Do not add other allowed products or complete filling the tank until the bags
have fully dissolved and pesticide is thoroughly mixed.
11. Once the WSP has fully dissolved and any other products have been added to
the tank, resume filling the tank with water to the desired level, close the tank lid, and
resume agitation.
12. Use the spray solution when mixing is complete.
13. Maintain agitation of the diluted pesticide mix during transport and application.
14. It is unlawful to use any registered pesticide, including WSPs, in a manner
inconsistent with its label.
ENGINEERING CONTROLS STATEMENT
Water soluble packets, when used correctly, qualify as a closed mixing/loading system
under the Worker Protection Standard [40 CFR 170.607(d)]. Mixers and loaders
handling this product while it is enclosed in intact water soluble packets may elect to
wear reduced PPE of long-sleeved shirt, long pants, shoes, socks, a chemical-resistant
apron, and chemical-resistant gloves. When reduced PPE is worn because a closed
system is being used, handlers must be provided all PPE specified above for "applicators
and other handlers" and have such PPE immediately available for use in an emergency,
such as in case of a spill or equipment break-down."
All outdoor foliar spray uses
Update the bee advisory box according to the following:
httDs://www.eDa.20v/Dollinator-Drotection/new-labeling-neonicotinoid-Desticides
Follows directly after the
Environmental Hazard
statement
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Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
All outdoor foliar spray uses
For foliar spray application to crops under contract pollinator services:
"Do not apply this product while bees are foraging. Do not apply this product until
flowering is complete and all petals have fallen unless the following condition has been
met. If an application must be made when managed bees are at the treatment site, the
beekeeper providing the pollination services must be notified no less than 48 hours prior
to the time of the planned application so that the bees can be removed, covered or
otherwise protected prior to spraying."
For foliar spray application to crops not under contract pollinator services:
"Do not apply this product while bees are foraging. Do not apply this product until
flowering is complete and all petals have fallen off unless the application is made in
response to a public health emergency declared by appropriate State or Federal
authorities."
Directions for use
All outdoor foliar spray uses
"Do not apply by ground within 25 feet, or by air within 150 feet of lakes, reservoirs,
rivers, permanent streams, marshes or natural ponds, estuaries and commercial fish farm
ponds."
Directions for use
Resistance-management
labeling statements for
insecticides and acaricides
Include resistance management label language for insecticides/acaricides from PRN
2017-1 rhttDs://www.eDa.eov/Desticide-reeistration/Desticide-reeistration-notices-vear).
Directions for Use, prior to
directions for specific crops
Additional Required Labeling
Action Applies to all products
delivered via liquid spray
applications
Remove information about volumetric mean diameter from all labels where such
information currently appears.
Directions for Use
Berries and small fruits, not
including grapes, set
maximum annual rate
Maximum annual application rate for berries regardless of application method is not
exceed 0.40 lbs. AI/A/yr.
Directions for use
Brassica (cole) leafy
vegetables, set maximum
annual rate for foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.20 lbs. AI/A/yr.
Directions for use
Leafy vegetables, set
maximum annual rate for
foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.20 lbs. AI/A/yr.
Directions for use
Fruiting vegetables, set
maximum annual rate for
Foliar spray only: maximum annual application rate is not to exceed 0.20 lbs. AI/A/yr.
Directions for use
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Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
foliar spray, and add
application timing restriction
based on crop stage
All: "Do not apply after the appearance of the initial flower buds until flowering is
complete and all petals have fallen off."
For tomatoes, peppers, chili peppers and okra only: "Do not apply after 5 days after
planting or transplanting regardless of application method."
Root and tuber vegetables, not
including potatoes, set
maximum annual rate for
foliar spray and soil drench
Foliar spray: maximum annual application rate is not to exceed 0.10 lbs. AI/A/yr.
Soil drench: maximum annual application rate is not to exceed 0.31 lbs AI/A/yr.
Directions for use
Legumes, not including
soybeans and peanuts, set
maximum annual rate for
foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.11 lbs. AI/A/yr.
Directions for use
Peanuts, set maximum annual
rate for foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.12 lbs. AI/A/yr.
Directions for use
Stone fruit, set maximum
annual rate for foliar spray
and soil drench
Foliar spray: maximum annual application rate is not to exceed 0.40 lbs. AI/A/yr.
Soil drench: maximum annual application rate is not to exceed 0.34 lbs. AI/A/yr.
Directions for use
Pome fruit, set maximum
annual rate for foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.40 lbs. AI/A/yr.
Directions for use
Tree nut set maximum annual
rate for foliar spray and soil
drench
Foliar spray: maximum annual application rate is not to exceed 0.30 lbs. AI/A/yr.
Soil drench: maximum annual application rate is not to exceed 0.36 lbs. AI/A/yr.
Directions for use
Cotton set maximum annual
rate
Regardless of application method, apply no more than 0.37 lbs. active ingredient per acre
per year, including seed treatment, soil drench and foliar sprays.
Directions for use
Cucurbit, add application
timing restriction based on
crop stage
For foliar spray and soil drench: "Do not apply after vining or appearance of the first true
(non-cotyledon) leaf until harvest."
Directions for use
Avocado, banana, dates, and
olives, add application timing
restriction based on crop stage
Foliar spray: "Do not apply before bloom until after flowering is complete and all petals
have fallen off."
Soil drench: "Do not apply once bloom has occurred until the next growing season."
Directions for use
All agricultural foliar spray
uses
"VEGETATIVE FILTER STRIPS
Construct and maintain a vegetative filter strip, according to the width specified below,
of grass or other permanent vegetation between the field edge and nearby down gradient
aquatic habitat (such as, but not limited to, lakes; reservoirs; rivers; permanent streams;
marshes or natural ponds; estuaries; and commercial fish farm ponds).
Directions for use
65
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
Only apply products containing imidacloprid onto fields where a maintained vegetative
filter strip of at least 10 feet exists between the field edge and where a down gradient
aquatic habitat exists.
Western irrigated agriculture is exempt from this requirement. Western irrigated
agriculture is defined as irrigated farmland in the following states: WA, OR, CA, ID,
NV, UT, AZ, MT, WY, CO, NM, and TX (west of 1-35).
For further guidance on vegetated filter strips, refer to the following publication for
information on constructing and maintaining effective buffers: Conservation Buffers to
Reduce Pesticide Losses. Natural Resources Conservation Services.
fatt.Ds://www.tiresJisda.eov/Inteniet/FSE DOCIJMENTS/nrcsl44o2 030970.odf"
Ornamentals, which includes
ornamental ground cover,
Christmas trees, ornamental
and/or shade trees, ornamental
herbaceous plants, ornamental
nonflowering plants,
ornamental woody shrubs and
vines
"Intended for use by professional applicators."
Directions for use
Ornamentals, which includes
ornamental trees, forestry,
ornamental woody shrubs and
vines, and outdoor
greenhouse/nursery set
maximum annual rate for
foliar spray and soil drench.
Does not include indoor
commercial nursery,
Christmas trees, greenhouse
uses, or forestry use on public
land and quarantine
application by USD A.
For both foliar spray and soil drench: maximum annual application rate is not to exceed
0.30 lbs. AI/A/yr.
Directions for use
Turf/sod set maximum annual
rate
Maximum annual application rate regardless of application method is not to exceed 0.34
lbs. AI/A/yr.
Directions for use
66
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
Poultry houses set maximum
number of applications and
add maximum application
area
"Do not apply more than one whole house treatment and 5 perimeter (partial house)
treatments per year."
"Do not apply to more than 30,000 sq. ft. per year per house."
Directions for use
Seed treatments, add to seed
bad tag
Add the following statements to labels to clean up spills, dispose of excess seed to avoid
contamination of water bodies:
"Cover or collect treated seeds spilled during loading and planting in areas (such as in
row ends)."
"Dispose of all excess treated seed by burying seed away from bodies of water."
"Do not contaminate bodies of water when disposing of planting equipment wash
water."
Directions for use
All outdoor non-agricultural
spray applications
"All outdoor spray applications must be limited to spot or crack-and-crevice treatments
only, except for the following permitted uses:
1. Application to soil, lawn, turf, and other vegetation;
2. Perimeter band treatments of 7 feet wide or less from the base of a man-made
structure to pervious surfaces (e.g., soil, mulch, or lawn)
3. Applications to the side of a man-made structure, up to 2 feet above ground level;
4. Applications to underside of eaves, soffits, doors, or windows permanently protected
from rainfall by a covering, overhang, awning, or other structure;
5. Applications around potential exterior pest entry points into man-made structures such
as doorways and windows, when limited to a band not to exceed one inch;
6. Applications to vertical surfaces directly above pervious surfaces such as bare soil,
lawn, turf, mulch or other vegetation, and not over a hard impervious surface (e.g.,
driveways, sidewalks), drainage, or other condition that could result in runoff into storm
drains, drainage ditches, gutters, or surface waters, to control occasional invaders or
aggregating pests."
Directions for Use
Outdoor non-agricultural
spray applications
"Do not apply directly to impervious horizontal surfaces such as sidewalks, driveways,
and patios except as a spot or crack-and-crevice treatment."
"Do not apply or irrigate to the point of run-off."
Directions for use
67
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
Outdoor non-agricultural
spray applications - rain
related statements (except for
products that require
watering-in)
"Do not make applications during rain. Avoid making applications when rainfall is
expected within 24 hours to allow product sufficient time to dry."
"Excessive rainfall within 24 hours after application may cause unintended run-off of
pesticide application."
Directions for use
Outdoor non-agricultural spot
treatments
"Spot treatment is application to limited areas on which insects are likely to occur, but
which will not be in contact with food or utensils and will not ordinarily be contacted by
workers. These areas may occur on floors, walls, and bases or undersides of
equipment. Spot treatments must not exceed two square feet in size (2ft. by 1 ft.), not to
exceed 10% of the entire treatment area."
Directions for use
Spray Drift Management
Application Restrictions for
all products delivered via
liquid spray application and
allow aerial application
"MANDATORY SPRAY DRIFT MANAGEMENT
Aerial ADDlications:
• Do not release spray at a height greater than 10 ft above the ground or vegetative
canopy, unless a greater application height is necessary for pilot safety.
• Applicators are required to use a medium or coarser (ASABE S572.1) droplet size.
• Do not apply when wind speeds exceed 15 mph at the application site. If the
windspeed is greater than 10 mph, the boom length must be 65% or less of the
wingspan for fixed wing aircraft and 75% or less of the rotor diameter for
helicopters. Otherwise, the boom length must be 75% or less of the wingspan for
fixed-wing aircraft and 90% or less of the rotor diameter for helicopters
For aerial applicators, if the windspeed is 10 miles per hour or less, applicators must
use Vi swath displacement upwind at the downwind edge of the field. When the
windspeed is between 11-15 miles per hour, applicators must use 3/i swath
displacement upwind at the downwind edge of the field
Do not apply during temperature inversions."
Directions for Use, in a box
titled "Mandatory Spray
Drift Managment" under the
heading "Aerial
Applications"
Spray Drift Management
Application Restrictions for
products that allow airblast
applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Airblast annlications:
• Sprays must be directed into the canopy foliage.
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
Directions for Use, in a box
titled "Mandatory Spray
Drift Management" under
the heading "Airblast
Applications"
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Docket Number EPA-HQ-OPP-2008-0844
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Description
Proposed l.sihel l.singusige lor Imidncloprid Products | Phiccmcnl on l.sihcl
• User must turn off outward pointing nozzles at row ends and when spraying outer
row.
• Do not apply during temperature inversions."
Spray Drift Management
Application Restrictions for
products that are applied as
liquids and allow ground
boom applications
"MANDATORY SPRAY DRIFT MANGEMENT
Ground Boom ADDlications:
• User must only apply with the release height recommended by the manufacturer, but
no more than 4 feet above the ground or crop canopy.
• Applicators are required to use a medium or coarser droplet size (ASABE S572.1).
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
• Do not apply during temperature inversions."
Directions for Use, in a box
titled "Mandatory Spray
Drift Management" under
the heading "Ground Boom
Applications"
Spray Drift Management
Application Restrictions for
products that are applied as
liquids and allow boom-less
ground sprayer applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Boom less Ground ADDlications:
• Applicators are required to use a medium or coarser droplet size (ASABE S572.1)
for all applications.
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
• Do not apply during temperature inversions."
Directions for Use, in a box
titled "Mandatory Spray
Drift Management" under
the heading "Boomless
Applications"
Advisory Spray Drift
Management Language for all
products delivered via liquid
spray application
"SPRAY DRIFT ADVISORIES
THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT.
BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL
CONDITIONS.
IMPORTANCE OF DROPLET SIZE
An effective way to reduce spray drift is to apply large droplets. Use the largest droplets
that provide target pest control. While applying larger droplets will reduce spray drift,
the potential for drift will be greater if applications are made improperly or under
unfavorable environmental conditions.
Controlling Droplet Size - Ground Boom (note to registrants: remove if ground boom
is prohibited on product labels)
• Volume - Increasing the spray volume so that larger droplets are produced will reduce
spray drift. Use the highest practical spray volume for the application. If a greater spray
volume is needed, consider using a nozzle with a higher flow rate.
• Pressure - Use the lowest spray pressure recommended for the nozzle to produce the
target spray volume and droplet size.
• Spray Nozzle - Use a spray nozzle that is designed for the intended application.
Consider using nozzles designed to reduce drift.
Directions for Use, just
below the Spray Drift box,
under the heading "Spray
Drift Advisories"
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Description
Proposed I.:ihc-l I.;iii«ii;i«c lor Iniidncloprid Products
Phiceinenl on l.sihcl
Controlling Droplet Size - Aircraft (note to registrants: remove if aerial application is
prohibited on product labels)
• Adjust Nozzles - Follow nozzle manufacturers' recommendations for setting up
nozzles. Generally, to reduce fine droplets, nozzles should be oriented parallel with the
airflow in flight.
BOOM HEIGHT - Ground Boom (note to registrants: remove if ground boom is
prohibited on product labels)
For ground equipment, the boom should remain level with the crop and have minimal
bounce.
RELEASE HEIGHT - Aircraft (note to registrants: remove if aerial application is
prohibited on product labels)
Higher release heights increase the potential for spray drift.
SHIELDED SPRAYERS
Shielding the boom or individual nozzles can reduce spray drift. Consider using
shielded sprayers. Verify that the shields are not interfering with the uniform deposition
of the spray on the target area.
TEMPERATURE AND HUMIDITY
When making applications in hot and dry conditions, use larger droplets to reduce
effects of evaporation.
TEMPERATURE INVERSIONS
Drift potential is high during a temperature inversion. Temperature inversions are
characterized by increasing temperature with altitude and are common on nights with
limited cloud cover and light to no wind. The presence of an inversion can be indicated
by ground fog or by the movement of smoke from a ground source or an aircraft smoke
generator. Smoke that layers and moves laterally in a concentrated cloud (under low
wind conditions) indicates an inversion, while smoke that moves upward and rapidly
dissipates indicates good vertical air mixing. Avoid applications during temperature
inversions.
WIND
Drift potential generally increases with wind speed. AVOID APPLICATIONS
DURING GUSTY WIND CONDITIONS.
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Description
Proposed l.sihel l.singusige lor Imidncloprid Products
Phiccmcnl on l.sihcl
Applicators need to be familiar with local wind patterns and terrain that could affect
spray drift."
Advisory Spray Drift
Management Language for
products that are applied as
liquids and allow boom-less
ground sprayer applications
"SPRAY DRIFT ADVISORIES
Boom less Ground ADDlications:
• Setting nozzles at the lowest effective height will help to reduce the potential for
spray drift."
Directions for Use, just
below the Spray Drift box,
under the heading "Spray
Drift Advisories"
Advisory Spray Drift
Management Language for all
products that allow liquid
applications with handheld
technologies
"SPRAY DRIFT ADVISORIES
Handheld Technology ADDlications:
• Take precautions to minimize spray drift."
Directions for Use, just
below the Spray Drift box,
under the heading "Spray
Drift Advisories"
Admire' 2I (I.P \ Resist r;K ion Number 2(i4-75S) lahel chan^e
PHI revision for pomegranate
PHI for pomegranate is 7-days.
Directions for use
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Appendix C: Endangered Species Assessment
In 2013, the EPA, along with the Fish and Wildlife Service (FWS), the National Marine
Fisheries Service (NMFS), and the United States Department of Agriculture (USDA) released a
summary of their joint Interim Approaches for assessing risks to endangered and threatened
(listed) species from pesticides16. These Interim Approaches were developed jointly by the
agencies in response to the National Academy of Sciences' (NAS) recommendations that
discussed specific scientific and technical issues related to the development of pesticide risk
assessments conducted on federally threatened and endangered species.
Since that time, EPA has conducted biological evaluations (BEs) on three pilot chemicals
representing the first nationwide pesticide consultations. These initial consultations were pilots
and were envisioned to be the start of an iterative process. The agencies are continuing to work
to improve the consultation process. For example, advancements to the initial pilot interim
methods have been proposed based on experience conducting the first three pilot BEs. Public
input on those proposed revisions is currently being considered.
Also, a provision in the December 2018 Farm Bill included the establishment of a FIFRA
Interagency Working Group to provide recommendations for improving the consultation process
required under section 7 of the Endangered Species Act for pesticide registration and
Registration Review and to increase opportunities for stakeholder input. This group includes
representation from EPA, NMFS, FWS, USDA, and the Council on Environmental Quality
(CEQ). Given this new law and that the first nationwide pesticide consultations were envisioned
as pilots, the agencies are continuing to work collaboratively as consistent with the congressional
intent of this new statutory provision. EPA has been tasked with a lead role on this group, and
EPA hosted the first Principals Working Group meeting on June 6, 2019.
Given that the agencies are continuing to develop and work toward implementation of
approaches to assess the potential risks of pesticides to listed species and their designated critical
habitat, the ecological risk assessment supporting this PID for imidacloprid does not contain a
complete ESA analysis that includes effects determinations for specific listed species or
designated critical habitat. Although the EPA has not yet completed effects determinations for
specific species or habitats, for this PID, the EPA's evaluation assumed, for all taxa of non-target
wildlife and plants, that listed species and designated critical habitats may be present in the
vicinity of the application of imidacloprid. This will allow the EPA to focus its future evaluations
on the types of species where the potential for effects exists once the scientific methods being
developed by the agencies have been fully vetted. Once that occurs, these methods will be
applied to subsequent analyses for imidacloprid as part of completing this registration review.
16 https://www.epa.gov/endangered-species/draft-revised-method-national-level-endangered-species-risk-
assessment-process
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Appendix D: Endocrine Disruptor Screening Program
As required by FIFRA and FFDCA, the EPA reviews numerous studies to assess potential
adverse outcomes from exposure to chemicals. Collectively, these studies include acute, sub-
chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity,
developmental, reproductive, and general or systemic toxicity. These studies include endpoints
which may be susceptible to endocrine influence, including effects on endocrine target organ
histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates,
reproductive loss, and sex ratios in offspring. For ecological hazard assessments, the EPA
evaluates acute tests and chronic studies that assess growth, developmental and reproductive
effects in different taxonomic groups. As part of its most recent registration decision for
imidacloprid, the EPA reviewed these data and selected the most sensitive endpoints for relevant
risk assessment scenarios from the existing hazard database. However, as required by FFDCA §
408(p), imidacloprid is subject to the endocrine screening part of the Endocrine Disruptor
Screening Program (EDSP).
The EPA has developed the EDSP to determine whether certain substances (including pesticide
active and other ingredients) may have an effect in humans or wildlife similar to an effect
produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator
may designate." The EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a
chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal
systems. Chemicals that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where the
EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data.
Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the
substance, and establish a dose-response relationship between the dose and the E, A, or T effect.
Under FFDCA § 408(p), the agency must screen all pesticide chemicals. Between October 2009
and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals,
which contains 58 pesticide active ingredients and 9 inert ingredients. The agency has reviewed
all of the assay data received for the List 1 chemicals and the conclusions of those reviews are
available in the chemical-specific public dockets. A second list of chemicals identified for EDSP
screening was published on June 14, 2013,17 and includes some pesticides scheduled for
Registration Review and chemicals found in water. Neither of these lists should be construed as a
list of known or likely endocrine disruptors. Imidacloprid is not on either list. For further
information on the status of the EDSP, the policies and procedures, the lists of chemicals, future
lists, the test guidelines and the Tier 1 screening battery, please visit the EPA website.18
In this PID, the EPA is making no human health or environmental safety findings associated with
the EDSP screening of imidacloprid. Before completing this registration review, the agency will
make an EDSP FFDCA § 408(p) determination.
17 See http://www.regiitations.gov/#idoeumentDetait;D=EPA~HQ~OPPT~2009~0477~0074 for the final second list of
chemicals.
18 https://www.epa.gov/endocrine-dismption
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Appendix E: Summary of Proposed Tolerance Actions
Imidacloprid 40 CFR §180.472. Summary of Proposed Tolerance Actions
Commodity
Currently
Established
Tolerance (ppm)
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition)
§180.472(a) General
Acerola
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Almond, hulls
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Apple
0.5
-
Tolerance should be revoked upon establishment
of Fruit, pome, group 11-10
Apple, wet pomace
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Aspirated grain fractions
240
240
Grain, aspirated fractions
Atemoya
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Avocado
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Banana
0.50
0.5
Correct number of significant figures to be
consistent with EPA policy
Beet, sugar, molasses
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Beet, sugar, tops
0.50
0.5
Correct number of significant figures to be
consistent with EPA policy
Biriba
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Caneberry, subgroup 13-A
2.5
2.5
Caneberry subgroup 13-07A
Canistel
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Cattle, fat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Cattle, meat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Cattle, meat byproducts
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Celtuce
-
6
Commodity displaced by the crop group
conversion.
Cherimoya
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Citrus, dried pulp
5.0
5
Correct number of significant figures to be
consistent with EPA policy
Coffee, green bean
0.8
1
Flarmonize with Codex MRL
Cotton, gin byproducts
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Cotton, meal
8.0
8
Correct number of significant figures to be
consistent with EPA policy
Cotton, undelinted seed
6.0
6
Correct number of significant figures to be
consistent with EPA policy
Custard apple
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Feijoa
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Fennel, florence, fresh leaves
and stalk
-
6
Commodity displaced by the crop group
conversion.
Fruit, citrus, group 10
0.7
1
Fruit, citrus, group 10-10, Flarmonize with Codex
MRL
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Imidacloprid 40 CFR §180.472. Summary of Proposed Tolerance Actions
Commodity
Currently
Established
Tolerance (ppm)
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition)
Fruit, pome, group 11
0.60
0.6
Corrected value to be consistent with EPA
Rounding Class Practice. Fruit, pome, group 11-10
Fruit, stone, group 12
3.0
3
Corrected value to be consistent with EPA
Rounding Class Practice. Fruit, stone, group 12-12
Goat, fat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Goat, meat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Goat, meat byproducts
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Grain, cereal, forage, fodder
and straw, group 16, forage,
except rice
7.0
7
Correct number of significant figures to be
consistent with EPA policy
Grain, cereal, forage, fodder
and straw, group 16, hay,
except rice
6.0
6
Correct number of significant figures to be
consistent with EPA policy
Grain, cereal, forage, fodder
and straw, group 16, stover,
except rice
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Grain, cereal, forage, fodder
and straw, group 16, straw,
except rice
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Grape
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Grape, juice
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Grape, raisin
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Guava
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Herbs subgroup 19A, dried
herbs
48.0
48
Herb subgroup 19A, dried herbs. Correct number
of significant figures to be consistent with EPA
policy
Herbs subgroup 19-A, fresh
herbs
8.0
8
Corrected value to be consistent with EPA
Rounding Class Practice. Herb subgroup 19A,
fresh herbs
Hog, fat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Hog, meat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Hog, meat byproducts
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Hop, dried cones
6.0
6
Correct number of significant figures to be
consistent with EPA policy
Horse, fat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Horse, meat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Horse, meat byproducts
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
llama
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Jaboticaba
1.0
1
Correct number of significant figures to be
consistent with EPA policy
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Imidacloprid 40 CFR §180.472. Summary of Proposed Tolerance Actions
Commodity
Currently
Established
Tolerance (ppm)
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition)
Kava, leaves
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Kava, roots
0.40
0.4
Correct number of significant figures to be
consistent with EPA policy
Kohlrabi
-
6
Commodity displaced by the crop group
conversion.
Leaf petioles subgroup 4B
6.0
6
Correct number of significant figures to be
consistent with EPA policy
Leaf petioles subgroup 4B
6.0
6
Corrected value to be consistent with EPA
Rounding Class Practice. Leaf petiole vegetable
subgroup 22B
Leafy greens subgroup 4A
3.5
3.5
Leafy greens subgroup 4-16
Lettuce, head
3.5
-
See Leafy greens subgroup 4-16
Lettuce, leaf
3.5
-
See Leafy greens subgroup 4-16
Longan
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Lychee
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Mango
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Milk
0.10
0.1
Correct number of significant figures to be
consistent with EPA policy
Nut, tree, group 14
0.05
0.05
Nut, tree, group 14-12
Okra
1
-
Tolerance should be revoked upon establishment
of Vegetable, fruiting, group 8-10
Onion, dry bulbs, subgroup 3-
07A
0.15
0.15
Onion, bulb, subgroup 3-07A
Papaya
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Passionfruit
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Pecan
0.05
-
Tolerance should be revoked upon establishment
of Nut, tree, group 14-12
Persimmon
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Pistachio
0.05
-
Tolerance should be revoked upon establishment
of Nut, tree, group 14-12
Pomegranate
0.90
0.9
Correct number of significant figures to be
consistent with EPA policy
Potato, chip
0.40
0.4
Corrected value to be consistent with EPA
Rounding Class Practice. Potato, chips
Potato, processed potato waste
0.90
0.9
Correct number of significant figures to be
consistent with EPA policy
Pulasan
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Rambutan
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Sapodilla
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Sapote, black
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Sapote, mamey
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Sheep, fat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
76
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Docket Number EPA-HQ-OPP-2008-0844
www.regulations.gov
Imidacloprid 40 CFR §180.472. Summary of Proposed Tolerance Actions
Commodity
Currently
Established
Tolerance (ppm)
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition)
Sheep, meat
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Sheep, meat byproducts
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Soursop
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Soybean, forage
8.0
8
Correct number of significant figures to be
consistent with EPA policy
Soybean, meal
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Spanish lime
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Star apple
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Starfruit
1.0
1
Correct number of significant figures to be
consistent with EPA policy
Strawberry
0.50
0.5
Correct number of significant figures to be
consistent with EPA policy
Sugar apple
0.30
0.3
Correct number of significant figures to be
consistent with EPA policy
Tomato, paste
6.0
6
Correct number of significant figures to be
consistent with EPA policy
Tomato, puree
3.0
3
Correct number of significant figures to be
consistent with EPA policy
Vegetable, brassica leafy,
group 5
3.5
3.5
Brassica head and stem vegetable group 5-16
Vegetable, cucurbit, group 9
0.50
0.5
Corrected value to be consistent with EPA
Rounding Class Practice.
Vegetable, fruiting, group 8
1.0
1
Corrected value to be consistent with EPA
Rounding Class Practice. Vegetable, fruiting,
group 8-10
Vegetable, leaves of root and
tuber, group 2
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Vegetable, legume, group 6,
except soybean
4.0
4
Correct number of significant figures to be
consistent with EPA policy
Vegetable, root and tuber,
group 1, except sugar beet
0.40
0.4
Correct number of significant figures to be
consistent with EPA policy
Vegetable, root and tuber,
group 1, except sugar beet
0.40
0.4
Corrected value to be consistent with EPA
Rounding Class Practice. Vegetable, root and tuber
(except sugar beet), subgroup IB
Watercress
3.5
-
Tolerance should be revoked upon establishment
of Leafy greens subgroup 4-16
Watercress, upland
3.5
-
Tolerance should be revoked upon establishment
of Leafy greens subgroup 4-16
Waxjambu
1.0
1
Correct number of significant figures to be
consistent with EPA policy
§180.472(d) Indirect or inadvertent residues
Soybean, vegetable
-
0.3
Only commodity not covered by vegetable,
legume, group 6, except soybean tolerance in (a).
Vegetable, legume, group 6
0.3
-
Covered by vegetable, legume, group 6, except
soybean tolerance in (a) and soybean, vegetable in
(d).
77
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