Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Dinotefuran
Proposed Interim Registration Review Decision
Case Number 7441
January 2020
Approved by:
Elissa Reaves, Ph.D.
Director
Pesticide Re-evaluation Division
Date: 1-22-2020
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Table of Contents
I. INTRODUCTION 4
A. Summary of Dinotefuran 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 16
3. Tolerances 16
4. Human Health Data Needs 18
B. Ecological Risks 18
5. Risk Summary and Characterization 19
6. Ecological Incidents 26
7. Ecological and Environmental Fate Data Needs 26
C. Benefits Assessment 27
IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION 32
A. Proposed Risk Mitigation and Regulatory Rationale 32
1. Cancellation of Uses 33
2. Application Rate Reductions 34
3. Crop Stage Restrictions 36
4. Residential Ornamental Advisory 37
5. Label Language Improvements 38
6. Spray Drift and Runoff Reduction 38
7. Pesticide Resistance Management 43
B. Stewardship 43
C. Tolerance Actions 45
D. Proposed Interim Registration Review Decision 45
E. Data Requirements 46
V. NEXT STEPS AND TIMELINE 46
A. Proposed Interim Registration Review Decision 46
B. Implementation of Mitigation Measures 46
Appendix A: Summary of Proposed Actions for Dinotefuran 47
2
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Appendix B: Proposed Labeling Changes for Dinotefuran Products 48
Appendix C: Endangered Species Assessment 57
Appendix D: Endocrine Disruptor Screening Program 58
3
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
I. INTRODUCTION
This document is the Environmental Protection Agency's (EPA or the agency) Proposed Interim
Registration Review Decision (PID) for dinotefuran (PC Code 044312, case 7441), 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 dinotefuran, can be found in the EPA's public docket (EPA-HQ-OPP-
2011-0920) at www. regulation s. 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 dinotefuran 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 dinotefuran prior to completing the dinotefuran
registration review. Likewise, the agency will complete endocrine screening for dinotefuran,
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 dinotefuran registration
review.
Dinotefuran is a broad-spectrum systemic, neonicotinoid insecticide (in the nitroguanidine
subclass), which acts on the neonicotinoid acetylcholine receptors (nAChRs) of the central
nervous system of insects. Dinotefuran is categorized in the Mode of Action subclass 4A by the
4
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Insecticide Resistance Action Committee (IRAC), a specialist technical group of the
agrochemical industry association CropLife. Dinotefuran is used to target a variety of pests
including aphids, whiteflies, thrips, leafhoppers, stinkbugs, mole crickets, white grubs, beetles
and lacebugs. Products containing dinotefuran can be applied in both agricultural and non-
agricultural settings. Agricultural use sites include, but are not limited to, cucurbit vegetables,
grapes, nut trees, fruiting vegetables, brassica vegetables and leafy vegetables. Non-agricultural
use sites include forest trees, ornamental plants, turf, animal and pet premises, and
commercial/industrial buildings. There are 58 Section 3 product registrations, 12 Section 24 (c)
Special Local Needs Registrations (SLN), and 13 Section 18 Emergency Exemptions containing
dinotefuran. The first dinotefuran product was registered in the United States in 2004, and
therefore dinotefuran was not subject to the reregi strati on process under FIFRA.
This document is organized into 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 dinotefuran is used and summarizes data on its use; Scientific Assessments, which
summarizes the EPA's risk and benefits assessments, updates or revisions to previous risk
assessments, and provides broader context with a discussion of risk characterization; 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 dinotefuran,
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 Dinotefuran Registration Review
Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for dinotefuran 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 dinotefuran.
December 2011 - The Dinotefuran 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 2012 - The Dinotefuran Final Work Plan (FWP) was issued. During the comment
period for the Dinotefuran Summary Document the agency received one public comment,
which did not result in changes to the work plan, data requirements or timeline in the
PWP.
March 2013 - Generic Data Call-In (GDCI) for dinotefuran was issued for data needed to
conduct the registration review risk assessments. For dinotefuran, all data requirements
were satisfied.
5
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
January 2017 - The agency announced the early availability of the Draft Assessment of
the Potential Effects of Dinotefuran on Bees, a 60-day public comment period was later
opened to coincide with the other neonicotinoids starting May 25, 2017 and ending July
24, 2017.
December 2017 - The agency announced the availability of the following documents to
support Registration Review for 120-day public comment period which included a 60-
day comment period extension:
o Preliminary Ecological Risk Assessment (excluding terrestrial invertebrates) for
the Registration Review of Dinotefuran
o Dinotefuran: Registration Review Drinking Water Assessment and the
Dinotefuran: Human Health Draft Risk Assessment for Registration Review
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Cotton
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Citrus
January 2020 - The agency is now announcing the availability of the PID and the Final
Bee Risk Assessment to Support the Registration Review of Dinotefuran in the docket, for
a 60-day public comment period. Along with the PID, the following documents are also
posted in the dinotefuran 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 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
o Assessment of Usage, Benefits and Impacts of Potential Mitigation in Stone Fruit
Production for Four Nitroguanidine Neonicotinoid Insecticides (Clothianidin,
Dinotefuran, Imidacloprid, and Thiamethoxam), 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, 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
6
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
o Comparative analysis of Aquatic Invertebrate Risk Quotients generatedfor
neonicotinoids using Raby et al. (2018) toxicity data, January 7, 2020
o Final Bee Risk Assessment to Support the Registration Review of Dinotefuran,
January 14, 2020
o Note to Reader: Documents Supporting the Registration Review of Dinotefuran
B. Summary of Public Comments on the Draft Risk Assessments and Agency
Responses
Two separate comment periods were held in 2017 for the dinotefuran risk assessment documents.
The Draft Assessment of the Potential Effects of Dinotefuran on Bees was published on January
12, 2017 for a 60-day public comment period. The draft human health and non-pollinator
ecological risk assessments for dinotefuran, and various supporting benefits-related registration
review documents, published on December 21, 2017 for a 120-day public comment period.
Although the initial comment deadline for these registration review documents was February 20,
2018, the comment period was extended for an additional 60 days, resulting in a revised
comment submission deadline of April 21, 2018.
Across these two comment periods, the agency received a total of 727 public comments.
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 OPP's Pesticide Re-evaluation Division to Comments on the Draft
Risk Assessments of 4 Neonicotinoid Insecticides available in the public docket. 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.
Dinotefuran: Response to Public Comments Regarding the Draft Bee and Non-Bee
Ecological Risk Assessments for the Registration Review of Dinotefuran. January 7, 2020.
Dinotefuran: Response to Comments on the Human Health Risk Assessment for
Registration Review (EPA-HQ-OPP-2011-0920-0753), October 5, 2018.
Additionally, the agency received comments on 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 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
7
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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-HQ-OPP-2011-0920-0583):
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 draft pollinator risk assessments.
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 dinotefuran. 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 Mitsui Chemicals Agro, Inc. (MCAG),
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 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
8
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Registration Review Risk Assessments Across the Four Neonicotinoid Pesticides (Imidacloprid,
Thiamethoxam, Clothianidin, and Dinotefuran) and Dinotefuran: Response to Public Comments
Regarding the Draft Bee and Non-Bee Ecological Risk Assessments for the Registration Review
of Dinotefuran, available in the public dockets.
Summary of MCAG Comments (EPA-HQ-OPP-2011-0920-0588):
MCAG Comment: MCAG stated "On pages 1, 9, 10, 14, 20, 21, 35, 63, 64, 66, 67, 69, 71, 72,
118, and 127, maximum application rates and risk assessment results and conclusions are
presented for Crop Subgroup 14: Tree Nuts. There are no tolerances for dinotefuran on Crop
Subgroup 14: Tree Nuts. Dinotefuran labels show use rates for Ornamental Non-bearing Nut
Trees. As this assessment is not intended to include ornamental uses of dinotefuran, all mention
of Tree Nuts should be removed."
EPA Response: EPA appreciates the clarification on the Crop Subgroup 14: Tree Nuts use. The
final bee assessment includes ornamental non-bearing nut trees as part of the evaluation of
ornamental uses of dinotefuran and removes reference to Crop Subgroup 14.
MCAG Comment: MCAG identified numerous errors throughout the document, including:
reported endpoints, reported residues, and citations.
EPA Response: EPA appreciates the editorial corrections and has incorporated all changes as
appropriate in the final bee risk assessment, which will be published along with the Proposed
Interim Decision for dinotefuran. These corrections do not impact the analyses or conclusions
presented in the final risk assessment.
MCAG Comment: MCAG provided several comments related to the clarification of Tier I risk
conclusions for acute exposures to larval bees and requested EPA modify risk conclusion
statements to clarify that risks from acute larval exposures are not anticipated for tuberous and
corm vegetables or for any soil application.
EPA Response: EPA appreciates the clarification provided on risk conclusions and notes that
conclusions presented in the final bee risk assessment are based on the available Tier I and II
toxicity data as well as the submitted residue studies. The Tier I conclusions, which formed the
basis for the draft bee risk assessment, are now summarized in Table 5.9 of the final
assessment.
MCAG Comment: MCAG commented on the approach to estimating off-field exposure via
spray drift described in the draft bee risk assessment and concludes "exposure to residues
deposited off-site are not significant and given the uncertainties inherent in the risk assessment
assumptions, no spray buffers are needed to protect honeybees."
EPA Response: EPA estimated off-field exposure via spray drift according to label directions,
and current internal guidance and models.
MCAG Comment: MCAG stated "the chronic larval toxicity endpoint should be set at a no
observed adverse effect concentration (NOAEC) of 0.33 [j,g/larva (corresponding to 0.0825
9
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
(j,g/larva/day) with a lowest observed adverse effect concentration (LOAEC) of 0.85 jag ai/larva
(corresponding to 0.2125 (j,g/larva/day) based on the 22 -day observation."
EPA Response: EPA updated the statistics for the 8-d larval mortality, 15-d pupal mortality, and
21-d adult emergence endpoints using the Cochran-Armitage trend test (consistent with OECD
guidance). The resulting NOAEC and LOAEC for 8-d larval mortality are <0.13 and 0.13
ug/larvae, respectively, based on statistically significant 14% effect (p = 0.01) at lowest
concentration tested. The DER has been amended with updated statistics but did not change the
most sensitive endpoint or resulting NOAEC/LOAEC values. This does not result in a change to
the risk assessment or prior conclusions.
Summary of Comments (Academia, BK, CBD, CFS, CLA, DBG, NRDC, NWF, PSC,
USD A, 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
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 (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.
10
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 schedule 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 were submitted on the bee bread method to
evaluate pollen exposure, specifically that an unvetted method should not be used (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 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 residues in
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
concerned the scientific methodology or rationale in these assessments. These comments were
received from a variety of stakeholders including, but not limited to, the Agricultural Retailers
Association (ARA), AVAAZ, the Bay Area Clean Water Agencies (BACWA), MCAG, the
California Department of Pesticide Regulation (CDPR), CropLife America (CLA), North Dakota
Grain Growers Association (NDGGA), Louisiana State University Agricultural Center, the San
Francisco Bay Regional Water Quality Control Board (SFBRWQCB), the University of
Minnesota (UMN). 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-
11
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Pollinator Registration Review Risk Assessments Across the Four Neonicotinoid Pesticides
(Imidacloprid, Thiamethoxam, Clothianidin, and Dinotefuran) and Dinotefuran: Response to
Public Comments Regarding the Draft Bee and Non-Bee Ecological Risk Assessments for the
Registration Review of Dinotefuran, available in the public dockets.
Summary of Comments (AVAAZ, BACWA, CDPR, CLA, SFBRWQCB, XSIC):
Commenters (EPA-HQ-OPP-2008-0844-1192, EPA-HQ-2008-0844-1116, EPA-HQ-OPP-2011-
0920-0750, EPA-HQ-OPP-0920-0712, EPA-HQ-OPP-2011-0920-0693) 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-2011-0920-0711) 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
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.
Comment Submitted by MCAG (EPA-HQ-OPP-2011-0920-0728):
MCAG provided information suggesting that dinotefuran is different than the other
nitroguanidine substituted neonicotinoids (imidacloprid, clothianidin, and thiamethoxam), stating
"based on the available toxicity data, dinotefuran is generally less acutely and chronically toxic
than the other neonicotinoids".
12
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
EPA Response: In the ecological risk assessments for the nitroguanidine-substituted
neonicotinoids (referred to as "neonicotinoids"), the aquatic invertebrate toxicity data available
at the time of publication was characterized. The neonicotinoids evaluated include clothianidin,
dinotefuran, imidacloprid and thiamethoxam. Of the four chemicals, imidacloprid has the largest
database of aquatic invertebrate toxicity data. Although clothianidin and thiamethoxam had
fewer data available than imidacloprid, there were still data for several different test species,
including aquatic life stage insects. Dinotefuran had the smallest toxicity database of all four
chemicals, relying heavily upon cladoceran data, which are not sensitive to the neonicotinoids
relative to other tested aquatic invertebrate species.
There are some important notes relevant to the available toxicity databases. First, there is a
difference in sensitivity among test species to the same neonicotinoid. Among different mayfly
species, the neonicotinoids have 96-h LC50 values that span orders of magnitude. Therefore, the
most sensitive toxicity endpoints used in risk assessment may be dependent upon which species
are tested. In the case of imidacloprid, which has the largest database of toxicity data, the fact
that this chemical has the lowest toxicity endpoints may not be a function of its lower toxicity
but rather of the sensitivity of the tested species. The most sensitive test species for imidacloprid
was Cloeon dipterum (a mayfly) for acute exposures and Caenis horaria (also a mayfly) for
chronic exposures. At the time of the original risk assessments, none of the other three chemicals
had toxicity data for this test species.
After the draft ecological risk assessments for the neonicotinoids were posted to the docket,
two studies were published focusing on the toxicity of these compounds to aquatic invertebrates
(Raby et al. 2018a and Raby et al. 2018b). EFED has reviewed these two studies and has
determined that their results may be used quantitatively for risk assessment purposes, i.e., to
derive Risk Quotients (RQs). Given that the toxicity data generated by Raby et al. 2018 (a
and b) were from the same lab, this data set allows for a unique opportunity to compare the
toxicities of the neonicotinoids, decreasing the variability that may be due to tests from different
labs. A complete discussion of the comparative risk of the four nitroguanidine substituted
neonicotinoids can be found in the memorandum "Comparative analysis of Aquatic Invertebrate
Risk Quotients Generated for Neonicotinoids using Raby et al. (2018) Toxicity Data" (US EPA,
2020).
As discussed in the analysis and considering the two most sensitive species tested, the four
chemicals are relatively similar in toxicity on an acute and chronic exposure basis for the mayfly,
but there were differences in sensitivities observed among the chemicals for the midge. When
considering exposure, dinotefuran tends to have the highest EECs among the four chemicals.
Overall, for the same uses, the chemicals represent a similar risk concern.
RQs for dinotefuran based on the acute and chronic toxicity data for the two most sensitive
species presented in Raby et al. are provided in Table 1 of Dinotefuran: Response to Comments
Regarding the Draft Bee and Non-Bee Ecological Risk Assessments for the Registration Review
of Dinotefuran. Those RQs supersede those presented in the draft risk assessment.
13
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
II. USE AND USAGE
Dinotefuran is a neonicotinoid insecticide (in the nitroguanidine subclass) that has contact and
systemic activity used to control a variety of insects. Dinotefuran has numerous agricultural and
non-agricultural uses. Agricultural use sites include field crops, fruits, and vegetables as well as
Christmas tree plantations, and dinotefuran can be applied via soil and foliar applications
methods (both ground and by air) as well as a tree/trunk injection. Non-agricultural uses include
indoor residential and commercial sites, including food handling establishments, outdoor
residential and commercial sites such as gardens, lawns, and ornamental plantings; and pets and
livestock. It is applied by both professional pest control operators and homeowners with surface,
space, and directed crack and crevice sprayers, and aerosol sprays. End-use formulations include
ready-to-use, pressurized liquids, dust, emulsifiable concentrates, granules, soluble concentrates,
pellets/tablets, impregnated material, and water-soluble packaging.
Agricultural Usage
From 2007-2017, dinotefuran usage averaged about 32,000 pounds AI1, applied to
approximately 230,000 acres2. Usage has been increasing over time. Major agricultural uses in
terms of total average pounds applied include rice, cotton, cucurbits, and fruiting vegetables1. In
terms of percent crop treated (PCT), cantaloupes and celery are the highest with an average of 25
percent; around 10 percent of the acreage in brassica vegetables and other cucurbits are treated
with dinotefuran.
In 2016, usage of dinotefuran was reported to be used for industrial vegetation management,
including forestry, but quantitative estimates were not reported3. In 2012, approximately 10,000
lbs AI of dinotefuran was estimated to have been used in horticultural nurseries and
greenhouses4.
Non-Agricultural Use
The agency has limited usage data on non-agricultural use sites. In 2014, approximately 37,000
lbs AI of dinotefuran was used in and around food handling establishments5. There was also
usage by professional pest control operations in and around other commercial establishments and
1 Dinotefuran (044312) Screening Level Usage Analysis (SLUA), July 8, 2019
2 Agricultural Market Research Data (AMRD). various years. 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.
3 Non-Agricultural Market Research Proprietary Data. 2017b. Studies conducted and sold by a consulting and
research firm. Report on vegetation management. [Accessed June 2019.]
4 Kline and Company, 2013. Professional Turf and Ornamental Markets for Pesticides and Fertilizers, 2012.
3 Kline and Company, 2015. Pest Control in Food Handling Establishments 2014: U.S. Market Analysis and
Opportunities. [Accessed June 2019.]
14
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
residential buildings reported in 2016, but quantitative estimates are not available6. Direct to
consumer sales are not reported in available usage data7.
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 dinotefuran. For additional details on the human health
assessment for dinotefuran, see the Dinotefuran: Human Health Draft Risk Assessment for
Registration Review, which is available in the public docket.
1. Risk Summary and Characterization
There are no residue chemistry, toxicology, or occupational/residential exposure data gaps for
dinotefuran. Acute and chronic dietary exposure and risk estimates are not of concern for
dinotefuran. Dinotefuran is classified as "not likely to be carcinogenic to humans" based on lack
of evidence of carcinogenicity in rats and mice and there is no evidence of mutagenicity.
Dinotefuran has low acute toxicity by oral, dermal, or inhalation exposure routes (Toxicity
Category III or IV). It does not irritate the eye (Toxicity Category IV), but causes a low level of
skin irritation (Toxicity Category IV); it is not a dermal sensitizer. The Food Quality Protection
Act (FQPA) Safety Factor (SF) for dinotefuran has been reduced to IX because (1) there is an
adequate toxicity database for dinotefuran; (2) the prenatal developmental studies in rabbits and
rats and the 2-generation reproduction study in rats showed no indication of increased
susceptibility to in utero and/or postnatal exposure to dinotefuran; (3) the neurotoxic potential of
dinotefuran has been adequately considered; and (4) there are no residual uncertainties identified
in the exposure databases. Therefore, the level of concern (LOC) = 100.
No hazard was identified for the short- and intermediate-term dermal and inhalation routes of
exposure, residential handler, occupational handler, and occupational post-application exposures
were not assessed. The only potential non-dietary exposure pathway that was quantitatively
assessed is the incidental oral exposure pathway for children 1 to <2 years old and the resulting
MOEs are greater than HED's level of concern (LOC = 100); however, although the exposure
pathway potentially exists, incidental oral post-application risk estimates did not result in risk
estimates of concern (MOEs > 100). Additionally, there were no aggregate risks of concern
identified.
6 Non-Agricultural Market Research Proprietary Data. 2017a. Studies conducted and sold by a consulting and
research firm. Report on professional turf and ornamental plants and professional pest control pesticide usage.
[Accessed June 2019.]
7 Non-Agricultural Market Research Proprietary Data. 2017a. Studies conducted and sold by a consulting and
research firm. Report on consumer pesticide usage. [Accessed June 2019.]
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Dietary, Residential Handler, Residential Post-Application, Aggregate, Bystander, and
Occupational Handler and Post-Application Risks
No risks of concern were identified for dietary, residential handler, residential post-application,
aggregate, or occupational handler or post-application exposures. The only potential post-
application exposure pathway that was quantitatively assessed is the incidental oral exposure
pathway for children 1 to <2 years old. The resulting MOEs range from 1,200 to 5,500,000 and
are significantly greater than the LOC of 100; therefore, there are no post-application risks of
concern. A quantitative bystander spray drift assessment for dinotefuran was not needed because
the potential residues from direct applications to residential turf are greater than the potential
residues resulting from drift from nearby agricultural endpoints (i.e., the residential post-
application risk assessment is protective of potential bystander risks.
Since no hazard was identified for the short-term and intermediate-term dermal and inhalation
routes of exposure, occupational handler and post-application exposures were not assessed, and
there are no expected risks of concern.
Cumulative Risks
EPA has not made a common mechanism of toxicity to humans finding as to dinotefuran and any
other substance and it does not appear to produce a toxic metabolite produced by other
substances. Therefore, EPA has not assumed that dinotefuran has a common mechanism of
toxicity with other substances for this assessment.
2. Human Incidents and Epidemiology
One hundred and two dinotefuran incidents were previously reviewed in 2011, and based on the
low severity and frequency of cases reported to IDS, further analysis was not warranted. In the
current analysis covering incidents reported from January 1, 2012 to July 11, 2017, five cases
involving a single active ingredient and 45 cases involving multiple active ingredients were
reported to Main IDS; another 810 cases are recorded in the Aggregate IDS (these incidents are
typically of low severity). A query of SENSOR-Pesticides 1998-2013 identified 31 cases
involving dinotefuran. Based on the continued low severity of dinotefuran incidents reported to
both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time.
The agency will continue to monitor the incident data. Additional analyses will be conducted if
ongoing human incident monitoring indicates a concern.
3. Tolerances
Tolerances are established under 40 CFR § 180.603 for residues of dinotefuran, including its
metabolites and degradates, for plants and livestock commodities as well as food handling
establishments. There are/were time-limited tolerances for stone and pome fruits (expires
12/31/2021) and fuzzy kiwifruit (expires 12/31/2022). EPA intends to update crop group
definitions for several commodities, revoke individual tolerances for some commodities that will
be covered in the appropriate crop groupings, and increase some tolerances to harmonize with
16
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Codex Maximum Residue Limits (MRLs); there are no MRLs established in Canada and Mexico
for dinotefuran.
Revisions are proposed at this time to include updated crop group definitions, update tolerances
per the EPA's guidance on trailing zeros, as well as increased tolerance levels for international
harmonization. Only the proposed tolerance revisions are presented in below. The agency will
use its FFDCA rulemaking authority to undertake the needed tolerance changes.
DinoU-l'iimn 4(1 ( TK 5j ISO.6113: Suniin;ir\ nl' Pnmiisi-ri Toknuuv Aiiiiuis
Commodity
Established
Tolerance
(ppiin
Proposed
Tolerance (ppm)
Comments
(correct commodity definition)
40 CFR 180.603 (a)(1) Plant Commodities
Brassica leafy greens subgroup 4-16B
-
15
1) Crop group conversion/revision
2) Correct number of significant figures to be consistent
with EPA policy
Brassica, head and stem, subgroup 5A
1.4
-
Tolerance should be revoked upon establishment of
Vegetable, Head and Stem Brassica, Group 5-16 and
kohlrabi
Brassica, leafy greens, subgroup 5B
15.0
-
Tolerance should be revoked upon establishment of
Brassica leafy greens subgroup 4-16B
Celtuce
5.08
5
1) Separate tolerance for celtuce is needed as it is left out
when crop group 4 is converted to 4-16A and 4-16B
2) Correct number of significant figures to be consistent
with EPA policy
Cotton, gin byproducts
8.0
8
Correct number of significant figures to be consistent
with EPA policy
Florence fennel
5.01
5
1) Separate tolerance for Florence fennel is needed as it is
left out when crop group 4 is converted to 4-16A and 4-
16B
2) Correct number of significant figures to be consistent
with EPA policy
Grape, raisin
2.5
3
1) Harmonization with Codex MRL
2) Correct number of significant figures to be consistent
with EPA policy
Kohlrabi
1.49
2
1) Separate tolerance for kohlrabi is needed as it is left
out when crop group 5 is converted to 5-16 and 22B
2) Harmonization with Codex MRL (increase from 1.4 to
2.0 ppm)
3) Correct number of significant figures to be consistent
with EPA policy
Leaf Petiole Vegetable Subgroup 22B
5
Crop group conversion/revision
Leafy greens subgroup 4-16A
-
5
Crop group conversion/revision and correct number of
significant figures to be consistent with EPA policy
Onion, green, subgroup 3-07B
5.0
5
Correct number of significant figures to be consistent
with EPA policy
Peach
1.0
1
Rice, grain
9.0
9
Tomato, paste
1.0
1
Turnip, greens
15.0
15
Vegetable, fruiting, group 8
0.7
-
Tolerance should be revoked upon establishment of
Vegetable, fruiting, group 8-10
Vegetable, fruiting, group 8-10
0.7
Crop group conversion/revision
Vegetable, Head and Stem Brassica,
Group 5-16
-
2
1) Crop group conversion/revision
8 At present, celtuce and Florence fennel are covered by crop group 4 tolerance.
9 At present, kohlrabi is covered by crop group 5A tolerance.
17
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
DinoU-l'iimn 4(1 ( TK 5j ISO.6113: Suniin;ir\ nl' Pnmiisi-ri Toknuuv Aiiiiuis
Commodity
1 Established
Tolerance
(ppm)
Proposed
Tolerance (ppm)
Comments
(correct commodity definition)
2) Harmonization with Codex MRL (increase from 1.4 to
2.0 ppm)
3) Correct number of significant figures to be consistent
with EPA policy
Vegetable, leafy, except Brassica, group
4
5.0
--
Tolerance should be revoked upon establishment of Teafy
greens subgroup 4-16A, Teaf Petiole Vegetable Subgroup
22B, celtuce, and Florence fennel
40Ch'R I HO. 603 (hj-Seclion IS
l i'Mii, pome, group 11-10
23
1) Commodity definition correction
2) Correct number of significant figures to be consistent
with EPA policy
Fruit pome, group 11
2.0
Remove
Fruit stone, group 12
2.0
Remove
4. Human Health Data Needs
There are no residue chemistry, toxicology, or occupational/residential exposure data gaps for
dinotefuran. No additional human health data are anticipated to be needed to support this
registration review at this time.
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 dinotefuran. For additional details on the ecological
assessment for dinotefuran, see the following documents, which are available in the public
docket (EPA-HQ-OPP-2011-0920) at www.regulations.gov.
o Preliminary Ecological Risk Assessment (excluding terrestrial invertebrates) for
the Registration Review of Dinotefuran
o Draft Assessment of the Potential Effects of Dinotefuran on Bees
o Final Bee Risk Assessment to Support the Registration Review of Dinotefuran
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 dinotefuran. See Appendix C for more details. As such, potential risks for
non-listed species only are described below.
18
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
5. Risk Summary and Characterization
Terrestrial Exposure
Dinotefuran is applied through aerial and ground application methods, which includes sprayers,
chemigation and soil drenching. For terrestrial wildlife, the agency modeled potential dietary
exposure based on consumption of dinotefuran residues on food items following spray (foliar or
soil) applications. Overall, acute risks to avian and mammalian species from foliar and soil
treatments of dinotefuran are not expected. Soil incorporation following soil treatments,
decreases potential risks from this use pattern considerably.
For terrestrial invertebrates, the primary routes of exposure assessed include contact of bees with
spray droplets and oral ingestion via pollen and nectar. Exposure can vary based on use patterns
and the attractiveness of a treated crop.
Mammals. Birds. Reptiles, and Terrestrial-Phase Amphibians
Dinotefuran is practically non-toxic to moderately toxic to birds (and to terrestrial-phase
amphibians and reptiles for which birds serve as surrogates) and practically non-toxic to
mammals on an acute basis. Overall, potential acute risks to birds and mammals from foliar and
trunk injection treatments appear to be low. There is the potential for acute effects to birds from
soil (spray) treatments at the highest application rate (0.54 lb AI/A; ornamentals including non-
bearing nut trees), with Risk Quotients (RQs) ranging from 0.01 to 0.8310 (soil incorporation
following soil treatments decreases potential risks from this use pattern considerably). Unlike the
other nitroguanidine substituted neonicotinoids, dinotefuran is not registered as a seed treatment
and thus, not a route of exposure.
Although the possibility of exposure exists for terrestrial wildlife such as mammals, birds,
reptiles, and terrestrial-phase amphibians, acute and chronic risks of concern have not been
identified for any of the assessed dinotefuran uses or application methods.
Terrestrial Invertebrates (honeybees) - Risk Estimates
This section incorporates information provided in the Draft Assessment of the Potential Effects of
Dinotefuran on Bees as well as the more recent Final Bee Risk Assessment to Support the
Registration Review of Dinotefuran, which are available in the public docket. The 2017 draft
pollinator assessment utilized available data to evaluate potential risk associated with the
registered agricultural uses of dinotefuran to bees alone. The available data included a
registration review required Tier I (individual bee) level dataset to help characterize the acute
and chronic toxicity of dinotefuran to adult and larval honeybees. In both assessments, available
open literature data were also reviewed.
The final 2019 bee risk assessment updates the draft pollinator assessment and incorporates
additional information submitted to the EPA since the time of the previous draft assessment. This
10 RQs exceeding the LOC represent potential risks of concern. The LOC for acute risks is 0.5.
19
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
new assessment includes data on residues of dinotefuran in nectar, pollen, and other plant
matrices associated with registered crop uses. It utilizes a residue bridging strategy to extrapolate
between 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 (colony) level) pollinator studies. Tier II data included a sucrose colony feeding
(dose-response) study to better evaluate potential colony level effects. Data were required based
on a tiered approach, as lower tiered data could trigger the need for higher tiered data.
The agency is concerned about potential risks from neonicotinoid use to all pollinators. During
testing, honeybees (Apis mellifera) were used as a surrogate for other species of pollinators (e.g.
bumblebees, monarchs, etc.). 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, the honeybees (Apis mellifera) are considered to be reasonable surrogates (in the
absence of data to the contrary) 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 nitroguanidine neonicotinoids (imidacloprid, clothianidin, thiamethoxam,
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, berries/small fruits, and ornamentals (including non-bearing nut trees).
Surrogate data were used where limited or no residue dinotefuran data were available. Generally,
the dinotefuran risk assessment finds that applications of dinotefuran to honeybee attractive
crops that are not harvested prior to bloom result in a potential for colony-level risk.
Dinotefuran is highly toxic to adult bees on an acute contact (48-hr LD50 = 0.024 |Lxg a.i./bee) and
oral (48-hr LD50 = 0.0076 |Lxg a.i./bee) basis. Dinotefuran is classified as non-toxic with
endpoints up to 3.3 |ig a.i./larva (111 mg a.i./kg diet) to honey bee larvae on an acute (single
dose dietary) exposure basis. RQ exceedances for larvae are orders of magnitude lower than
those of adults, with acute contact RQs ranging from 7.4 to 20. Acute RQ exceedances
associated with on-field foliar use of dinotefuran range from <0.3 to 760 and soil use
exceedances range from <0.1 to 12 (LOC = 0.4). The highest acute foliar RQ exceedances noted
are associated with use on brassica head and stem vegetables, fruiting vegetables, cucurbit
vegetables, bulb vegetables, stone fruit, and low growing berries (except strawberry); while the
highest soil-applied RQ exceedances result from use on potatoes, leafy vegetables, brassica head
and stem vegetables, fruiting vegetables, cucurbits, kiwi, tuberous and corm vegetables, and
small fruit vine climbing subgroup (except kiwi).
One study is available that examines the chronic toxicity of dinotefuran for adult honeybees
through dietary exposure. The NOAEC and the LOAEC based on mortality are 0.0015 and
0.0035 |Lxg a.i./bee, respectively. In a larval chronic 21-day study, individual honeybee (Apis
mellifera) larvae were exposed in vitro to technical grade dinotefuran. No statistically significant
differences were detected between the negative control and treatment groups for pupal mortality,
adult emergence, or growth (body weight of emerged bees); however, high mortality in the
control group observed at Day 14 limits the extent to which the study can detect treatment
20
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
effects. The NOAEC is less than the lowest dinotefuran treatment level {i.e., NOAEC: <0.0325
|ig a.i./larva/day). As with the acute data, RQ exceedances for honeybee larvae are orders of
magnitude lower than those of adults. Chronic RQ exceedances associated with on-field foliar
use of dinotefuran range from 28 to 3900 and soil use RQ exceedances range from 0.9 to 60.
Based on an analysis of Tier I data, for foliar applications, potential off-field dietary risks to
individual bees exposed to spray drift extend 1000 feet from the edge of the treated field. There
is uncertainty in this analysis including: assumption of 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.
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 dinotefuran residues measured
in pollen and nectar in various crops to levels that affect honey bee colonies. These analyses may
not reasonably represent non-Apis bees (e.g., bumblebees), due to different crop attractiveness.
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, which are conducted outside the laboratory, afford less control over these
other factors, and their role may become increasingly prominent as the duration of the study is
extended. Although study protocols attempt to minimize the confounding effects of other
21
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
environmental factors, there is uncertainty regarding the extent to which the effects of a chemical
may be substantially different had these other factors been not be in place.
Strongest Evidence of Risk: For foliar, soil, and trunk injection applications of dinotefuran, 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):
cotton (foliar)
stone fruit (foliar, pre-bloom)
berries (foliar, pre-bloom),
pollinator-attractive fruiting vegetables (foliar), and
pollinator-attractive ornamentals and forest trees (foliar, soil, trunk injection)
These findings are supported by multiple lines of evidence indicating that residues exceed the
dinotefuran colony-level NOAEC 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.
Moderate Evidence of Risk: For foliar and soil application of dinotefuran, the strength of
evidence is considered "moderate" in indicating a colony-level risk to honey bees for the
following registered uses:
cucurbits (foliar),
berries (soil, pre-bloom), and
turf (residential lawns with bee-attractive blooming weeds).
These findings are supported by lines of evidence indicating that residues exceed the dinotefuran
colony-level NOAEC but the magnitude, frequency and/or duration of exceedance is limited.
Weakest Evidence of Risk: For foliar and soil applications of dinotefuran, the strength of
evidence is considered "weakest" in indicating a colony-level risk to honey bees for the
following registered uses:
pollinator-attractive root/tubers (foliar, soil),
pollinator-attractive fruiting vegetables (soil), and
stone fruit (soil, pre-bloom)
Honeybees in particular play an important role in commercial pollination services for certain
crops. 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
22
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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.
Off-field drift of dinotefuran (from foliar spray applications) is another potential route of
exposure which can present risks to bees. Off-field drift was calculated via the AgDRIFT model
which considers a variety of factors including wind speed, spray nozzle type, release height, etc.
Spray drift from foliar treatments resulted in risks at greater than 1,000 feet from the field for
honey bees. Off-field estimates of risk are based on exposure estimates which cannot be refined
with available residue data. Moreover, these estimates relied on conservative 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, adult
chronic endpoints were considered very sensitive, even with the additional modeling (section
5.1.3 of the final pollinator assessment) using coarser droplet sizes, the drift distances were not
appreciably affected.
Terrestrial Plants
No risks of concern are identified for terrestrial plants. No effects were observed in the available
vegetative vigor and seedling emergence studies, which tested the maximum application rate for
dinotefuran. RQs were not calculated because the highest test concentrations did not yield
adverse effects.
Aquatic Risks
Dinotefuran is applied through aerial and ground application methods, which includes sprayers,
chemigation and soil drenching. For aquatic wildlife, the agency modeled potential exposure
based on the likelihood of dinotefuran residues reaching aquatic waterbodies. Dinotefuran's
chemical properties indicate it is readily soluble in water and that volatilization and
bioaccumulation in aquatic organisms are negligible. Dinotefuran is considered persistent in
aquatic environments with the exception of conditions that favor aqueous photolysis. The major
routes transporting dinotefuran from treatment sites to aquatic habitats include runoff and spray
drift.
Freshwater Invertebrates
From the initial Preliminary Ecological Risk Assessment (excluding terrestrial invertebrates) for
the Registration Review of Dinotefuran, meaningful acute and chronic RQs for dinotefuran to
freshwater invertebrates could not be calculated because definitive toxicity endpoints were not
available for data classified as quantitative. The RQs available were calculated based on
available qualitative data. EECs were highest for rice with a 1-day average water column level of
349 [j,g/L from combined (soil and foliar) applications. The use of dinotefuran on rice yielded the
highest chronic RQ for freshwater invertebrates (84, LOC = 1). Chronic RQs for all other crops
were at least an order of magnitude lower, ranging from 1.38 - 8.23. The acute RQ exceedance
for rice was highest at 34.9; with all other acute RQs ranging from 0.48 - 6.52 based on the most
23
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
sensitive species (trichoptera) data. Aquatic invertebrate exposure from the rice use is expected;
however, potential impacts could be limited based on available use practice information, limited
national geographic footprint, and best management practices such as increased water holding
times, water conservation practices, and in-furrow/row rice (non-flooded field) usage. These
factors, along with current buffer and spray drift label language, have the potential to
significantly reduce the potential for dinotefuran runoff to adjacent aquatic water bodies from the
aquatic risk driver, rice.
Comparative Analysis of Aquatic Invertebrate Risk Quotients
The agency generated a Comparative analysis of Aquatic Invertebrate Risk Quotients generated
for neonicotinoids using Raby et al. (2018) toxicity data, which became available following
publication of the Preliminary Ecological Risk Assessment (excluding terrestrial invertebrates)
for the Registration Review of Dinotefuran. 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. 2018a11 and
Raby et al. 2018b12). 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
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.
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.
12 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.
24
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
For 1), not all test concentrations were confirmed through analytical verification. As a result, the
LC50 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 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 RQs for estuarine/marine invertebrates in the initial dinotefuran non-pollinator draft risk
assessment did not show exceedances. Meaningful RQs could not be calculated for
estuarine/marine invertebrates on a chronic exposure basis because the available study showed
effects at all test concentration, resulting in a non-definitive NOAEC of < 44 (J,g/L, the lowest
concentration tested. At this lowest test concentration, effects on female dry weight were seen,
up to 17% decrease. This LOAEC of 44 ug/L was lower than modeled concentration for
maximum exposure scenario (rice) and within an order of magnitude of all other scenarios (EECs
range from 4.14 to 24.7 for all uses except rice, which is 252 ppb), suggesting that risk to
estuarine/marine invertebrates from chronic exposure to dinotefuran is uncertain, but cannot be
precluded.
Fish and Aquatic-Phase Amphibians
No effects were observed at the highest treatment levels tested for freshwater and
estuarine/marine fish (surrogate for aquatic-phase amphibians), RQ values therefore were not
25
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
particularly meaningful. As estimated environmental concentrations (EECs) do not approach
these treatment levels, direct risk to fish is not a concern.
While the potential risk of direct effects of dinotefuran 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
No risks of concern were identified for aquatic plants. Non-listed species RQs for vascular and
non-vascular aquatic plants could not be calculated because definitive toxicity endpoints are not
available for the tested species.
6. Ecological Incidents
There are no incidents reported for plants, aquatic or terrestrial vertebrates, or aquatic insects. All
of the available incidents reported are regarding bees. The search reflects reported incidents since
the initial registration of dinotefuran and includes any reports in the Incident Database System
(IDS) as of March 2019. The sources of information for incidents include, registrant reports
submitted under the FIFRA § 6(a)(2) reporting requirement, as well as reports from local, state,
national and international level government reports on bee kills, news articles, and
correspondence made to the EPA by phone or via email (through beekill@epa.eov) generally
reported by homeowners and beekeepers.
All reported incidents were associated with dinotefuran use on ornamentals, and their relevance
to agricultural uses are unknown. Four major incidents dated between June of 2013 and August
2015 on the west coast were noted, all involving large numbers of bumblebees and other insects
found dead around the treated ornamental trees (Myoporum and linden). Three of the four
incidents were associated with spray applications and one from basal trunk application. One
incident was associated with a June 2013 basal trunk application to linden trees resulting in a
number of bee deaths months was later found to be made by the Oregon Department of
Agriculture (ODA) in accordance with the label. During a similar timeframe, ODA also deduced
that another dinotefuran incident which resulted in 25,000 to 50,000 bumblebees killed as a
result of a misuse application not in accordance with label requirements. The remaining two
major incidents listed are still of unknown legality. More detail can be found in EPA's Final Bee
Risk Assessment to Support the Registration Review of Dinotefuran.
The agency will continue to monitor ecological incident information as it is reported to the
agency. Detailed analyses of these incidents will be conducted if reported information indicates
concerns for risk to non-target organisms.
7. Ecological and Environmental Fate Data Needs
There are no data deficiencies for the registered uses of dinotefuran with regards to ecological
and environmental fate and effects. The agency does not anticipate any further ecological and
environmental fate and effects data needs for the dinotefuran registration review at this time.
26
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 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;
Alternatives to dinotefuran, depending on the crop or use site and target pest, include
organophosphates, pyrethroids, and carbamates, as well as alternative nitroguanidine and
chloropyridinyl neonicotinoids such as imidacloprid, thiamethoxam, and acetamiprid,
respectively.
The following are summaries of the benefits assessments available in the public docket13.
Cotton
Although registered for cotton, surveys of insecticide use in an available cotton report showed
little or no usage of dinotefuran as of 2015. More recent data14, through 2017, show an increase
in usage. There are anecdotal reports of dinotefuran used against Silverleaf whitefly in the
Southeast. The Silverleaf whitefly is a pest that only sporadically reaches damaging levels.
For more information, see Benefits of Neonicotinoid Insecticide Use in the Pre-Bloom and Bloom
Periods of Cotton.
Citrus
Dinotefuran is only registered for non-bearing ornamental citrus trees. Its primary benefit is
likely as part of an overall strategy to control the Asian citrus psyllid (ACP) and other citrus
pests in residential and nursery setting to ultimately protect commercial production from
Huanglongbing bacterial disease (HLB), also known as citrus greening disease (UC IPM,
2019)15. ACP vectors HLB, which negatively affects both the quantity and quality of fruit and
may kill trees within a few years. There may be limited options for insecticides to control the
ACP in residential areas; dinotefuran and other neonicotinoids may provide both immediate
13 https://www.re giitations.gov/doeket?D=EPA~HQ~OPP~ 10
14 Dinotefuran (044312) Screening Level Usage Analysis (SLUA), July 8, 2019
15 UC IPM, 2019. "Floriculture and Ornamental Nurseries: Citrus Pests." University of California Agricultural
Extension
27
-------
Docket Number EPA-HQ-OPP-2011 -0920
www.regulations.gov
contact and residual control, reducing the need for frequent applications of contact insecticides
like pyrethroids.
Grape
Usage of dinotefuran on grapes is relatively low compared to imidacloprid and clothianidin;
however, in terms of agricultural crops to which dinotefuran is applied, grapes are one of the top
three in average pounds of dinotefuran applied. Applications of nitroguanidine neonicotinoids to
table, raisin, and wine grapes are often made post-bloom, with imidacloprid being the leading
insecticide prior to and during bloom. Neonicotinoids, like dinotefuran, provide rapid control via
contact activity and residual control through systemic activity, as well as an important rotation
partner for resistance management and in providing disease control and prevention.
Dinotefuran is used to target primarily leafhoppers, including sharpshooter, and mealybugs.
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.
For more information, see Benefits of Neonicotinoid Insecticide Use in Grapes and Impacts of
Potential Mitigation.
Rice
Dinotefuran is a foliar-applied insecticide to control rice stink bugs late season. Dinotefuran is
applied to 92,300 acres annually. The national PCT for rice is only 3%, but rice is a top
agricultural use site with 3,000 lbs. AI applied per year. Use in Texas accounts for nearly 90% of
dinotefuran applied to rice nationally and the average PCT for rice grown in Texas is 43%. The
average application rate used in Texas is 0.095 pounds active ingredient per acre compared to the
maximum labeled rate of 0.131 pounds active ingredient per acre. In Texas, an average of 1.2
applications are made per year.
While there is potential for yield losses associated with rice stink bug feeding, the major concern
with their feeding is reduction in quality of grain, because the discoloration reduces the price
farmers are paid for their crop and reduces the ability to export. Rice stink bug is only considered
a pest in the Mid-South and Gulf Coast. Dinotefuran is a critical tool to combat pyrethroid-
resistant rice stink bugs in Texas. Dinotefuran provides growers with the greatest flexibility in
rice stink bug control over alternatives, such as pyrethroids or carbaryl, due to its greater residual
control, short pre-harvest interval (PHI), and no water-holding period requirements.
For more information, see Usage and Benefits of Neonicotinoid Insecticides in Rice and
Response to Comments.
Stone Fruit
Among the stone fruits, dinotefuran is only registered for use on peaches and nectarines. The
nitroguanidine neonicotinoids as a group are used to control a variety of pests in stone fruits.
Important pests targeted by dinotefuran in these crops include the plum curculio, plant bugs, and
stinkbugs. Approximately 2% of the peach and nectarine crops are treated with dinotefuran, and
about 200 pounds of active ingredient are applied to 1,800 acres of peaches and nectarines
annually. The average single application rate of dinotefuran use on peaches and nectarines is
28
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
0.123 pounds of active ingredient per acre. On average, one treatment is made annually. Given
the low usage of dinotefuran in peaches and nectarines, the agency did not assess rate reduction
impacts.
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).
Pome Fruit
Neonicotinoid target pests for pome fruit (apple and pear) include several economically
significant pests that can reduce pome fruit yield. The major use of the nitroguanidine
neonicotinoids is during the post-bloom to harvest periods of the pome fruit production cycle.
However, 20-30% of neonicotinoid usage occurs during the pre-bloom and bloom period. Early
season control can be important to manage early season pests that can build up to high
population densities if not controlled early season.
Dinotefuran use on apples is small, and negligible in pears as it is currently only available in that
crop as a FIFRA Section-18 emergency exception use. There are relatively few instances of
dinotefuran use in the market research database in recent years and thus the agency did not assess
the impact of a potential application rate reduction on users. Dinotefuran use on pome fruit
accounts for an average of 1,700 total acres treated and 200 pounds applied at 1% PCT. The
average application rate for dinotefuran use on pome fruit is 0.122 pounds active ingredient per
acre.
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)
Berries
Berries refer to strawberry, caneberry (e.g., blackberry and raspberry), cranberry, and blueberry,
as well as multiple other small soft fruit grown on very small acreage. Dinotefuran is only
registered for use on cranberry and blueberry.
Berry pests, targeted by the neonicotinoids, cause direct feeding damage which can cause
reductions in the aesthetic quality of harvested fruit (e.g., tarnished plant bug, cranberry root
weevil, blueberry maggot), transmit diseases which can result in plant death and/or crop loss
(e.g., aphids, leafhoppers). The detection of a single individual of some of these pests (e.g.,
blueberry maggot) in harvested fruit can result in processors or buyers rejecting all of the harvest
from an entire field.
To date, imidacloprid and thiamethoxam are the most frequently used and/or recommended
neonicotinoids. Dinotefuran was registered for cranberry and blueberry in 2016; current usage
data and recommendations do not provide much information. It is recommended in crop manuals
for control of cranberry root weevil16 in cranberry. Dinotefuran can be utilized as both a foliar
16 Murray et al., 2017; Rodriguez-Saona, 2013b; Guedot et al., 2018; DeLange et al., 2015
29
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
application (for immediate contact control) and soil application (for residual control) for some
berry crops.
For more information, see Benefits of NeonicotinoidInsecticide Use in Berries (Strawberry,
Caneberry, Cranberry, and Blueberry) and Impacts of Potential Mitigation.
Cucurbits
The cucurbits benefits assessment 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 primarily aphids, whitefly, and cucumber
beetle. Although imidacloprid is the most utilized neonicotinoid active ingredient on cucurbits,
there is considerable usage of dinotefuran. Dinotefuran usage however is relatively low, except
for usage on cantaloupe (4,200 average lbs. applied per year; 23 PCT) and squash (1,000; 9
PCT).
Extension publications recommend up to three applications of neonicotinoids on cucurbits,
primarily dinotefuran, to control whiteflies and prevent cucurbit yellow stunting disorder virus
(CYSDV) across the season (Palumbo 2017). Dinotefuran is also recommended at-plant with
two subsequent applications during emergence-to-vining (Palumbo 2017). According to pesticide
market research data (2013-2017), imidacloprid is most commonly used in cucurbits prior to
crop emergence while dinotefuran may be more commonly applied in the emergence-to-vining
period.
Dinotefuran is mostly applied to cucurbits foliarly, accounting for two-thirds of all dinotefuran-
treated acres, and soil applications make up the other third. Growers applied dinotefuran at or
near the foliar labeled maximum application rate on 46% of foliarly-treated acres and applied
dinotefuran at or near 0.267 lbs. AI/A on 97% of soil-treated acres. Thus, a 10% rate reduction
would have a significant impact on growers using dinotefuran via foliar application. A 20% rate
reduction to 0.262 lbs. AI/A, would impact more than 90% of soil-treated acres of dinotefuran.
For more information, see Benefits of Neonicotinoid Insecticide Use in Cucurbit Production and
Impacts of Potential Risk Mitigation.
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
In general, neonicotinoids, including dinotefuran, are widely used and provide high benefits to
the producers of fruiting vegetables, leafy vegetables, and Brassica vegetables. Dinotefuran
provides 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 it is
systemic, both soil and foliar applications can be used, permitting growers flexibility in terms of
application timing and method. Dinotefuran is less widely used in production of root and tuber
crops, bulb vegetables, 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,
which may include other neonicotinoids such as imidacloprid. Proposed restrictions on the use of
imidacloprid may increase the use of, and the benefits of, dinotefuran.
30
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
For more information, see Benefits of Neonicotinoid Use and Impacts of Potential Mitigation in
Vegetables, Legumes, Tree Nuts, Herbs, Tropical and Subtropical Fruit Crops.
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 ornamentals 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 ornamentals.
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 ornamentals, 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.
31
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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,
including dinotefuran 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
EPA's risk management approach for the neonicotinoids aims to preserve a key tool for growers
while maximizing targeted risk reduction. Mitigation is being proposed for the potential
ecological risks of concern noted for pollinators and 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 dollars17. 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
proposing mitigation that reduces impact to honeybees that are also expected to benefit other
17 USD A, National Agricultural Statistics Service (NASS), Agricultural Statistics Board. (2018).
32
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 dinotefuran uses
through the following risk mitigation measures:
Cancel use on bulb vegetables;
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 dinotefuran
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 dinotefuran,
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 dinotefuran. The EPA is also proposing
label changes to address general labeling improvements for all dinotefuran products.
1. Cancellation of Uses
The agency is proposing cancellation of dinotefuran use on bulb vegetable crops in order to
mitigate potential exceedances to aquatic invertebrates. In a review of available comparative
data, dinotefuran was found to have similar chronic LOC exceedances to the other
neonicotinoids which calculated potential risk to aquatic invertebrates from bulb use reached
33
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
RQs over 500 for aquatic invertebrates. Dinotefuran is rarely used on bulb vegetables; between
2013 and 2017, less than one percent of the acres grown was treated with dinotefuran. Although
there are some particular benefits of neonicotinoids in general for the control of thrips, effective
alternatives to the neonicotinoids, including dinotefuran, remain available for use on bulbs. In
consideration of the high potential risk and the relatively low expected impacts to bulb growers,
EPA is proposing cancellation of this use.
See Benefits of Neonicotinoid Use and Impacts of Potential Risk Mitigation in Vegetables,
Legumes, Tree Nuts, Herbs, and Tropical and Subtropical Fruit Crops for more information.
2. Application Rate Reductions
As noted in section III.B. of this PID, EPA has identified several categories of ecological risks of
concern as a result of dinotefuran uses, including pollinators and aquatic invertebrates. To help
mitigate these risks, EPA is proposing the following reductions in the maximum allowable
annual application rates for foliar and soil applications of dinotefuran products:
Table 1. Proposed Maximum Annual Application Rates for Dinotefuran
Crop/Crop (Jroup
Current Rale (M:i\. Annual)
Proposed Milion (Max. Annual)
Leafy Vegetables
Foliar: 0.268 lbs. AI/A/yr
Foliar: 0.23 lbs. AI/A/yr
Brassica/Cole
Foliar: 0.266 lbs. AI/A/yr
Foliar: 0.23 lbs. AI/A/yr
Fruiting Vegetables
Foliar: 0.268 lbs. AI/A/yr
Foliar: 0.23 lbs. AI/A/yr
Cotton
Maximum combined annual
application rate regardless of
formulation type: 0.263 lbs.
AI/A/yr
Maximum combined annual
application rate regardless of
formulation type: 0.19 lbs. AI/A/yr
Production/Commercial
Ornamentals
Foliar and soil: 0.54 lbs. AI/A/yr
Foliar and soil: 0.40 lbs. AI/A/yr
Application rate reductions are being proposed for several uses in order to reduce potential risk
exceedances to both pollinators and aquatic invertebrates. For pollinators, these proposed rate
reductions focus on certain crops where pollinator/bee exposure and where the highest potential
reduction of risks to pollinators is possible. For pollinators and aquatic invertebrates, measured
rate reductions are a part of a multi-faceted approach to reducing overall exposure. The goal of
these proposed maximum annual application rate reductions is to reduce the total environmental
loading of neonicotinoids resulting from the various uses specified, while still providing growers
with the ability to use these tools as an effective means of pest control. Additional measures to
reduce risk to pollinators and aquatic invertebrates include spray drift and runoff reduction
language discussed in Section IV. A. 5 of this document.
As part of the assessments of the benefits of neonicotinoids, EPA also analyzed 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 reductions in risk
while minimizing the impacts on users of dinotefuran. Although these proposed rate reductions
do not eliminate all risks, they are expected to contribute to reducing risk overall. The benefits of
these uses outweighs the remaining reduced risks of concern.
34
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Leafy vegetables
For the leafy vegetables crop group, EPA is proposing reducing the current maximum annual
foliar application rate from 0.268 lbs. AI/A to 0.23. This rate reduction is targeted at reducing
potential risk to aquatic invertebrates.
Potential risk to aquatic invertebrates was noted for foliar applications of dinotefuran from leafy
vegetable use, with comparative neonicotinoid foliar RQs up to 989. Benefits of the use of
neonicotinoids are high, in general, but dinotefuran use on leafy vegetables is low, with PCTs
around 1%. Proposed restrictions on the use of imidacloprid, however, may result in growers
shifting to dinotefuran. Average annual application rate is 0.222 lbs. AI/A/year, lower than the
proposed mitigation. Around 40% of the acres treated with dinotefuran are treated at rates of
0.210 lbs AI/A/year or more although soil applications are included in this estimate. This
mitigation could preclude a grower from making a second application of dinotefuran; the
applicator would have to use an alternative insecticide. However, the number of acres affected
may be small.
Brassica/Cole
For the brassica/cole crop group which includes broccoli, cabbage, cauliflower, and similar
crops, EPA is proposing reducing the current maximum annual application rate from 0.266 lbs.
AI/A to not exceed a rate of 0.23 lbs. AI/A annually for foliar applications only. This rate
reduction is targeted at reducing potential risk to aquatic invertebrates and to align more with
average annual rates.
Potential risk to aquatic invertebrates was noted for both foliar and soil applications of
neonicotinoids from brassica/cole crop use, with comparative neonicotinoid RQs ranging up to
680 with the highest exceedances identified for foliar uses. In general, there are high benefits
from the use of neonicotinoids in brassica. Dinotefuran's use on brassica/cole crops averages less
than 10% of the crop treated, considerably less than imidacloprid and thiamethoxam. Average
annual application rates of dinotefuran applied nationally to brassica/cole is approximately 0.222
lbs. AI/A/year, below the proposed new rate, but around 40% of the acres treated with
dinotefuran are treated at rates of 0.210 lbs AI/A/year or more. This mitigation could preclude a
grower from making a second application of dinotefuran; the applicator would have to use an
alternative insecticide.
Fruiting Vegetables
For the fruiting vegetables crop group, EPA is proposing reducing the current maximum annual
foliar application rate from 0.268 to 0.23 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 dinotefuran from
fruiting vegetable use, with comparative neonicotinoid RQs up to 768. Benefits of neonicotinoid
use are high, but dinotefuran's use on fruiting vegetables, with PCTs around 5 - 10%, is much
lower than that of imidacloprid and thiamethoxam. The average annual rate for dinotefuran to
fruiting vegetables is 0.25 lbs. AI/A, above the proposed new rate, and annual rates above 0.210
lbs. AI/A are observed on about 75% of the treated acreage. However, soil applications are used
on some of these acres. This mitigation could preclude a grower from making a second
35
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
application of dinotefuran; the applicator would have to use an alternative insecticide, but the
number of acres affected, given the PCT, may be low.
Cotton
For cotton, EPA is proposing reducing the current maximum combined rate of 0.263 lbs. AI/A
regardless of formulation type and reducing it to 0.19 lbs. AI/A applied annually. This mitigation
is being proposed to address pollinator exceedances.
Potential risks from dinotefuran cotton foliar use was considered under the strongest category of
evidence for pollinator exceedances. Foliar adult honeybee RQs reached 56 on an acute basis and
2900 on a chronic basis. Cotton is considered to be one of the major drivers of potential
pollinator risk. To date, usage of dinotefuran on cotton has been sporadic; multiple applications
in a year appear rare. With consideration of current usage, the reduction in the annual rate is
unlikely to impact users.
Production/Commercial Ornamentals
For production/commercial ornamentals, EPA is proposing reducing the current maximum
annual foliar and soil application rate from 0.54 lbs. AI/A to 0.40. 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 mitigation does not include indoor
commercial nursery, greenhouse uses, Christmas trees, or forestry use on public land and
quarantine application by USD A.
Potential risks from dinotefuran use on ornamentals was included under the strongest category of
evidence for pollinator exceedances. Residues exceeded the colony-level endpoint for periods of
time ranging from 22 days (foliar applications) to 617 days (soil applications). In addition,
multiple ecological incidents have been associated with dinotefuran applications to ornamental
plants that span foliar and soil applications methods. Ornamentals are considered to be one of the
major drivers of potential pollinator and aquatic invertebrate risk. Benefits are considered to be
high for this use of dinotefuran as data showed that an average of 139,000 lbs. are applied
annually. Other than the available 2014 Aglnfomatics report and review, usage data was limited.
This rate reduction is considered to potentially have moderate impacts on usage.
3. Crop Stage Restrictions
As noted in section III.B.l., 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 showing residues of neonicotinoids in
pollen and nectar over time. 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.
36
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Table 2. Proposed Crop St
age Restrictions for Dinotefuran
Crop/Crop (Jroup
Proposed Mili»;ilion
Fruiting Vegetables
The agency 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.
Additionally, for tomatoes, peppers, chili peppers and okra only, EPA is
also proposing to not apply after 5 days after planting or transplanting
regardless of application method.
Stone Fruit
The agency is proposing a crop stage restriction to prohibit application
from bud break until after petal fall is complete and all petals have fallen
off
Fruiting Vegetables
For the fruiting vegetables crop group, EPA is proposing a crop stage restriction for both foliar
and soil labels, 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 only, EPA is also proposing to prohibit application 5 days after planting or transplanting
regardless of application method for all crops in the crop group.
Potential risk to pollinators was noted under the strongest evidence of risk for foliar uses of
fruiting vegetables, and soil uses were listed under weakest evidence of risk. LOC exceedances
for pollinators were identified with RQs up to 3800. Benefits of neonicotinoid use are high, but
dinotefuran's use on fruiting vegetables, with PCTs about 5 - 7%, is much lower than that of
imidacloprid and thiamethoxam.
Applications of neonicotinoids after crop emergence or transplanting account for around two-
thirds of the treated acres of peppers and tomato acres. Dinotefuran targets season-long pests,
particularly aphids and whitefly that vector viral diseases, which can seriously impact the
development, quality and/or yield of the harvested fruit. The proposed restriction will preclude
most of these applications and is likely to result in impacts on growers.
Stone Fruit
For stone fruit, EPA is proposing a crop stage restriction to prohibit application from bud break
until after petal fall is complete and all petals have fallen off. Potential risk to pollinators was
noted under the strongest evidence of risk for foliar pre-bloom uses on stone fruit crops, while
soil uses were listed under weakest evidence of risk pre-bloom. There was low risk deemed to
pollinators from post-bloom uses. Exceedances to pollinators were identified with RQs ranging
up to 3900. EPA is targeting a 12-day pre-bloom interval to reduce potential exposure.
Dinotefuran has limited overall usage on stone fruit, and the majority of this use applied post-
bloom, therefore the proposed changes are not expected to significantly impact growers.
4. 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
37
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
identified. Benefits were considered high for this use, 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.
5. Label Language Improvements
EPA is proposing several advisory label language changes intended to better inform applicators
of pollinator risks and reduce pollinator exposures. 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.
6. 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 dinotefuran 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 dinotefuran.
The agency is proposing the following spray drift mitigation language be included on all
dinotefuran 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 dinotefuran registrants to standardize all advisory language on dinotefuran 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.
38
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 dinotefuran that can enter waterbodies from runoff, EPA is proposing a
vegetative filter strip (VFS) requirement for all dinotefuran agricultural products of 10 feet.
Currently some dinotefuran product labels have a 25 feet VFS requirement on labels, the
proposed mitigation would reduce this requirement to 10 feet across all relevant 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 dinotefuran
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 dinotefuran. 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:
39
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
"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 Reduction Mitigation
Applications are currently prohibited during temperature inversions, therefore the requirement
listed above does not represent a change in use directions. Requirements listed above for airblast
applications are also consistent with current requirements.
Wind Speed. Boom Length/Swath Displacement and Release Height
Current requirements for aerial applications are:
Do not apply when wind speeds exceed 10 mph at the application site. The boom length
must be 75% or less of the wingspan or rotor diameter.
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.
There are no proposed changes for release height. Proposed changes will allow applications at
higher wind speed, which will provide growers with greater flexibility to make applications in a
timely manner. Further, at wind speeds of 10 mph or less, the boom length for helicopter is
increased to 90 percent of the rotor diameter, which may necessitate fewer passes to complete an
application, likely decreasing application costs. Currently, there are no requirements for swath
displacement. The agency has not assessed the impacts 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.
Current requirements for ground applications are:
Do not apply when wind speeds exceed 10 mph at the application site.
The release height must be no higher than 10 feet from the top of the crop canopy or
ground
Proposed changes will allow applications at higher wind speed, which will provide growers with
greater flexibility to make applications in a timely manner. Based on previous reviews of
recommended release heights for optimal coverage across common nozzle types, a release height
of 4 feet or less should not impact growers when making applications of dinotefuran.
40
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Droplet Size
The agency is considering establishing a mandatory droplet size of medium or coarser.
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. Systemic insecticides, like dinotefuran, control
some insects regardless of droplet size due to the systemic movement within the plant. However,
neonicotinoids, including dinotefuran, are valuable because they have immediate, contact
activity, especially when applied to the foliage.
Generally, entomologists accept that good coverage is required for maximum efficacy during a
foliar application and that fine droplets provide better coverage than medium or coarser droplets.
Requiring larger droplet size than a grower would normally use could decrease the immediate,
contact control of pests, which could result in reduced yields or quality of produce. Furthermore,
higher rates of survival of the target pest(s) could undermine resistance management efforts by
selecting for more tolerant biotypes. To compensate, growers could use higher application rates
than they would otherwise, make more frequent applications, and/or select alternative products
(pyrethroids, carbaryl, diflubenzuron, etc., depending on the target pest). These actions would
increase pest control costs.
Buffers and Vegetative Filter Strips
Currently, a 25-foot VFS is required between the field edge and down gradient aquatic habitat to
prevent runoff. The proposed requirement for would reduce the size of the VFS to 10 feet and
require a 25-foot buffer from aquatic habitats for ground applications. Reducing the size of the
VFS could reduce the costs growers incur to maintain the VFS and potentially increase the
cultivated area of their fields, although they could not apply dinotefuran within the area
previously part of the VFS due to the proposed buffer.
However, the new 150-foot buffer from aquatic habitats for aerial applications represents a
substantial change that could impact usage of dinotefuran. Currently, aerial applications are used
for nearly two-thirds of the area treated with dinotefuran and is particularly common in rice,
lettuce, and brassica vegetables (MRD, 2013-2017).
If growing areas are adjacent to water bodies, buffers may require growers to leave a portion of
the land dedicated to crops untreated or remove land from production. 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.
Removing land from production can decrease revenue from lost crop area. EPA previously
estimated impacts of lost productive lands from increasing vegetative filter strips for pyrethroids,
which also restrict application near water bodies. Buffers do not need to be maintained like
vegetative filter strips, but the value of lost cropped area is likely to be similar. For the earlier
BEAD analysis, lost crop areas were presented for increases in lost area of 15 and 25 feet.
However, the proposed buffer for aerial applications is 150 feet, an increase of 125 feet over the
existing vegetative filter strip. Using the same method that was used for pyrethroids, the value of
the potential lost crop area from the increased buffer can also be estimated. The estimated
41
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
impacts disproportionally affect growers producing crops from small acreage fields, as a greater
portion of the total field is lost to a buffer. For example, dinotefuran is widely used on various
vegetable crops such as tomato. The median size tomato field is 5.4 acres, and if that field is
assumed to be rectangular with a waterbody along the long side, the lost crop value is estimated
to be $1,748 per acre for the increase in lost cropped area of 125 feet. The impacts are greater
for smaller fields. Ten percent of tomato fields are 0.2 acres or smaller and a 150-foot buffer
would preclude use of dinotefuran if the field were adjacent to a water body. Aerial applications
are particularly common on brassica crops. For broccoli, the median field size is 7.4 acres, and if
the aerial buffer meant production would be lost, the estimated revenue loss would be equivalent
to $1,985 per acre. For crops with lower revenue per acre or grown on larger fields, the
estimated loss per acre is lower, however impacts as a proportion of grower income may be
similar or even greater. The crop with the highest area treated with dinotefuran is rice, and the
median field size is 38.4 acres. The estimated cost, in terms of foregone production, of a 125-
foot increase in the buffer over the existing VFS in that field is equivalent to $112 per acre.
Instead of taking land out of production, a grower could switch to a different chemical that does
not have a buffer requirement, accept pest damage in the buffered areas, or apply an alternative
to only those areas of the field that is within the buffer.
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 dinotefuran 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 dinotefuran 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
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 for residential and
commercial use sites, in particular the definition of 'spot treatment'. In general, however, the
42
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
agency considers these measures consistent with application practices. The agency invites
comments if this mitigation would impact applicators.
In addition to including the following spray drift restrictions on dinotefuran labels, all references
to volumetric mean diameter (VMD) information for spray droplets are proposed to be removed
from all dinotefuran 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.
7. 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 dinotefuran, 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.eov/pesticide-reeistration/pm-2 guidance-pesticide-registrants-pesticide-
resi stan ce-management.
B. Stewardship
In addition to updating product labels to ensure pesticides continue to meet the safety standard,
EPA's registration review for the N-nitroguanidine neonicotinoids 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;
43
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 webpage18.
As highlighted by several of the proposed mandatory and advisory label statements outlined in
section IV. A. 1, users should not apply neonicotinoids when bees and other pollinators are
actively foraging on pollinator-attractive plants during bloom; 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 webpage19.
As highlighted in section III.B.l, 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 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. While the EPA is proposing advisory language for covering seeds and
cleaning up spillage, the American Seed Trade Organization has also published a guide20 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.
18 ll!tpsi//www^
19 https://www.epa.gov/poHinator-protection/what-yoii-can-do-protect-honey-bees-aiKl-other-poHiiBtors
20 https://seed4reatment-guide.coni/
44
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 conversion to updated crop groups for several crop groups, updates for
consistency with the EPA's policy on trailing zeros, and harmonization of certain tolerances with
Codex Maximum Residue Limits (MRLs); there are no MRLs established in Canada and Mexico
for dinotefuran. Tolerances are proposed to be revoked for vegetable leafy (except Brassica)
group 4, Brassica leafy greens subgroup 5B, Brassica head and stem subgroup 5A, and
vegetable fruiting group 8. Tolerances are proposed to be established for leafy greens subgroup
4-16 A, leaf petiole vegetable subgroup 22B, Brassica leafy greens subgroup 4-16B, vegetable
head and stem Brassica group 5-16, and vegetable fruiting group 8-10. For more details, all
proposed tolerance revisions for dinotefuran are listed in Section III.A.3. The agency will use its
FFDCA rulemaking authority to undertake needed tolerance 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 or
their labeling are needed at this time, as described in Section IV. A and Appendices A and B.
In this PID, the agency is making no human health or environmental safety findings associated
with the EDSP screening of dinotefuran, 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
45
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
the use of dinotefuran. The agency's final registration review decision for dinotefuran 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 dinotefuran 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 dinotefuran 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 dinotefuran. However, a
final decision for dinotefuran may be issued without the agency having previously issued an
interim decision. A final decision on the dinotefuran 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 dinotefuran registrants must submit
amended labels that include the label changes described in Appendices A - D. 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.
46
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Appendix A: Summary of Proposed Actions for Dinotefuran
Registration Rc\ic\\ Case . 7441
PC'Vodc < >443 12
Cheniieal Type insecticide
Chemical family \eonicotinoids
[Mode or Mechanism (for herhi ci ties )J of Action Nicotinic acetylcholine receptor (V\CI IR) compctili\c modulators
Affected
Populalion(s)
Source ol"
|-xposurc
Route of l-xposure
Duration ol"
Exposure
Potential Risk(s) ol"
Concern
Proposed Actions
Pollinators
Residues on
treated site
Ingestion and contact
Acute and
chronic
Acute and chronic
toxicity
Reduce application rates
Crop stage restrictions
(icncral other use restrictions
Spray drift reduction
Aquatic
ln\ ertehrates
RunolV from
treated sites
Ingestion and contact
Acute and
chronic
Acute and chronic
toxicity
Reduce application rates
Spray drift and runoff reduction
Vegetati\ e filter strips
I sc deletion for bulb \ cgclaMcs
Reduce perimeter treatment
applications
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Appendix B: Proposed Labeling Changes for Dinotefuran Products
Description
Proposed l.ahcl Language lor Dinoleruran Products
Placcmciil on l.ahcl
Technical Products
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.
Dinotefuran
GROUP
4A
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
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 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
48
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
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.
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.
49
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
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
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
Directions for use
50
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
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."
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
Brassica (cole) leafy
vegetables, set maximum
annual rate for foliar spray
Foliar spray only: maximum annual application rate is not to exceed 0.23 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 0.23 lbs. AI/A/yr
Directions for use
Fruiting vegetables, set
maximum annual rate for
foliar spray, and add
application timing restriction
based on crop stage
Foliar spray only: maximum annual application rate is not to exceed 0.23 lbs. AI/A/yr
For all outdoor uses: "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."
Directions for use
Stone Fruit add application
timing restriction based on
crop stage
"Do not apply from bud break until after petal fall is complete and all petals have fallen
off."
Directions for use
Cotton set maximum annual
rate
Regardless of application method, apply no more than 0.19 lbs. active ingredient per
acre per year, including soil drench and foliar sprays.
Directions for use
For 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
51
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
Only apply products containing dinotefuran 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.
httos://www.nrcs.usda.eov/Internet/FSE DOCUMENTS/nrcsl44D2 030970.Ddf"
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
Production/Commercial
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
0.40 lbs. AI/A/yr
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:
Directions for Use
52
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
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."
For 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
For 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
Spot treatment guidance
statement
"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 (2 ft. 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.
Directions for Use, in a box
titled "Spray Drift
Management" under the
heading "Aerial
Applications"
53
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
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."
Spray Drift Management
Application Restrictions for
products that allow airblast
applications
"SPRAY DRIFT
Airblast applications:
Sprays must be directed into the canopy.
Do not apply when wind speeds exceed 15 miles per hour at the application site.
User must turn off outward pointing nozzles at row ends and when spraying outer
row.
Do not apply during temperature inversions."
Directions for Use, in a box
titled "Spray Drift
Management" under the
heading "Airblast
Applications"
Spray Drift Management
Application Restrictions for
products that are applied as
liquids and allow ground
boom applications
"SPRAY DRIFT
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 "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
"SPRAY DRIFT
Boomless 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 "Spray Drift
Management" under the
heading "Boomless
Applications"
54
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccilicilt oil l.sihel
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.
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
Directions for Use, just
below the Spray Drift box,
under the heading "Spray
Drift Advisories"
55
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
Description
Proposed l.sihcl l.iingiiiige lor Dinolerursin Products
Phiccmcnt on l.sihel
Shielding the boom or individual nozzles can reduce spray drift. Consider using
shielded sprayers. Verily 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.
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"
56
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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 pesticides21. 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 dinotefuran 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 dinotefuran. 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 dinotefuran as part of completing this registration review.
21 https://www.epa.gov/endangered-species/draft-revised-method-national-level-endangered-species-risk-
assessment-process
57
-------
Docket Number EPA-HQ-OPP-2011-0920
www.regulations.gov
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
dinotefuran, 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), dinotefuran 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, 2013,22 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. Dinotefuran 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.23
In this PID, the EPA is making no human health or environmental safety findings associated with
the EDSP screening of dinotefuran. Before completing this registration review, the agency will
make an EDSP FFDCA § 408(p) determination.
22 See http://www.regiitations.gov/#idoeumentDetait;D=EPA~HQ~OPPT~2009~0477~0074 for the final second list of
chemicals.
23 https://www.epa.gov/endocrine-dismption
58
------- |