Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Clothianidin and Thiamethoxam
Proposed Interim Registration Review Decision
Case Numbers 7620 and 7614
January 2020
Approved by: '
Elissa Reaves, Ph.D.
Acting Director
Pesticide Re-evaluation Division
Date: 1-22-2020
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Table of Contents
I. INTRODUCTION 4
A. Summary of Clothianidin and Thiamethoxam Registration Review 5
B. Summary of Public Comments on the Draft Risk Assessments and Agency Responses 9
II. USE AND USAGE 17
III. SCIENTIFIC ASSESSMENTS 18
A. Human Health Risks 18
1. Risk Summary and Characterization 19
2. Human Incidents and Epidemiology 24
3. Tolerances 25
4. Human Health Data Needs 27
B. Ecological Risks 27
1. Risk Summary and Characterization 28
2. Ecol ogi cal Inci dents 41
i. Pollinator Incidents 41
ii. Aquatic and Non-Pollinator Terrestrial Incidents 42
3. Ecological and Environmental Fate Data Needs 43
C. Benefits Assessment 43
IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION 50
A. Proposed Risk Mitigation and Regulatory Rationale 50
1. Cancellation of Clothianidin Uses on Bulb Vegetables 52
2. Thiamethoxam Use Restrictions for Risks to Occupational Handlers 52
3. Glove and Respirator Requirements for Certain Occupational Handlers 53
4. Closed System Requirement for Thiamethoxam Corn Seed Treatments 56
5. Poultry House Use Requirements for Clothianidin 56
6. Application Rate Reductions 57
i. Clothianidin 57
ii. Thiamethoxam 60
7. Crop Stage Restrictions 62
i. Clothianidin 62
ii. Thiamethoxam 64
8. Advisory Statements for Clothianidin and Thiamethoxam Seed Treatment Uses 67
9. Residential Ornamental Advisory 67
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10. Spray Drift Reduction and Runoff Reduction 68
11. Pesticide Resistance Management 73
B. Stewardship 74
C. Tolerance Actions 75
D. Proposed Interim Registration Review Decision 76
E. Data Requirements 76
V. NEXT STEPS AND TIMELINE 76
A. Proposed Interim Registration Review Decision 76
B. Implementation of Mitigation Measures 77
Appendix A: Summary of Proposed Actions for Clothianidin and Thiamethoxam 78
Table 1: Summary of Proposed Actions for Clothianidin 78
Table 2: Summary of Proposed Actions for Thiamethoxam 79
Appendix B: Proposed Labeling Changes for Clothianidin and Thiamethoxam Products 80
Table 1: Proposed Labeling Changes for Clothianidin Products 80
Table 2: Proposed Labeling Changes for Thiamethoxam Products 91
Appendix C: Endangered Species Assessment 103
Appendix D: Endocrine Disruptor Screening Program 104
Appendix E: Summary of Proposed Tolerance Actions 106
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I. INTRODUCTION
This document is the Environmental Protection Agency's (EPA or the agency) Proposed Interim
Registration Review Decision (PID) for clothianidin and thiamethoxam (PC Codes 044309 and
060109, case numbers 7620 and 7614, respectively), and is being issued pursuant to 40 CFR §§
155.56 and 155.58. Clothianidin is a registered pesticide active ingredient but is also a major
metabolite and degradate of thiamethoxam. Therefore, the ecological risks for these two
chemicals were assessed together and both are included in this combined PID. 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 clothianidin and thiamethoxam, can be found
in the EPA's public docket (EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581) at
www.reeulatioms. 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.eov/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 clothianidin and thiamethoxam 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 clothianidin and thiamethoxam
prior to completing the clothianidin and thiamethoxam registration review. Likewise, the agency
will complete endocrine screening for clothianidin and thiamethoxam, 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 listed species assessment
and the endocrine screening for the clothianidin and thiamethoxam registration review.
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Clothianidin and thiamethoxam are systemic, neonicotinoid insecticides with unique spectrums
of activity that act on the nicotinic acetylcholine receptors (nAChRs) of the central nervous
system of insects. They are in the N-nitroguanidine group of neonicotinoids, in subclass 4A of
the Insecticide Resistance Action Committee (IRAC) mode of action classification scheme. The
target pests for clothianidin and thiamethoxam products include a diverse set of insect pests, such
as aphids, whiteflies, thrips, caterpillars, beetles, flies, stinkbugs, and others. Clothianidin and
thiamethoxam products are registered for use on a wide variety of crops (e.g. corn, cotton,
soybeans, root and tuber vegetables, pome fruit, stone fruit, berries, tree nuts, legumes, cereal
grains, and oilseed crops and herbs). They are also registered on non-agricultural use sites such
as turf, poultry houses, and ornamental plants. Products containing clothianidin and
thiamethoxam can be applied via methods such as aerial, ground foliar sprays, soil treatments,
chemigation and as a seed treatment. There are currently 45 active registered Section 3 end-use
products containing clothianidin and 77 containing thiamethoxam. Products containing
clothianidin were first registered in 2003 and products containing thiamethoxam were first
registered in 1999, and therefore, neither were subject to reregi strati on.
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 clothianidin and thiamethoxam are used and summarizes data on their respective
uses; Scientific Assessments, which summarizes the EPA's risks, updates or revisions to previous
risk assessments, and provides broader context with a discussion of risk characterization;
Benefits Assessments, which describes the utility of the chemical along with any potential
impacts of mitigation; the Proposed Interim Registration Review Decision, which describes the
mitigation measures proposed to address risks of concern and the regulatory rationale for the
EPA's PID; and, lastly, the Next Steps and Timeline for completion of this registration review.
While this PID focuses on the specific risks, benefits, and mitigation measures for clothianidin
and thiamethoxam, 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 the other N-nitroguanidine neonicotinoid pesticides (i.e., dinotefuran
and imidacloprid) are available in the public dockets established for these cases.
A. Summary of Clothianidin and Thiamethoxam Registration Review
Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for clothianidin and
thiamethoxam with the opening of a registration review docket for each of these cases. The
following summary highlights the docket opening and other significant milestones that have
occurred thus far during the registration review of clothianidin and thiamethoxam. The
registration review docket ID for clothianidin is EPA-HQ-OPP-2011-0865 and the registration
review docket ID for thiamethoxam is EPA-HQ-OPP-2011-0581.
• December 2011 - The clothianidin and thiamethoxam Preliminary Work Plans (PWPs)
and supporting documents were posted to the docket for a 60-day public comment period,
which was extended for 7 days. The following is a list of those documents:
o Clothianidin Summary Document Registration Review
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o Thiamethoxam Summary Document Registration Review
o Clothianidin. Human Health Assessment Scoping Document in Support of
Registration Review
o Thiamethoxam. Human Health Assessment Scoping Document in Support of
Registration Review
o Thiamethoxam Registration Review: Human Health Scoping Information
Regarding the Wood Preservative Uses (Post Peer Review Update)
o Registration Review: Problem Formulation for the Environmental Fate and
Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments
of Clothianidin,
o Registration Review: Problem Formulation for the Environmental Fate and
Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments
of Thiamethoxam
o Problem Formulation for the Environmental Fate and Ecological Risk,
Endangered Species, and Drinking Water Exposure Assessments in Support of the
Registration Review of Thiamethoxam Antimicrobial Uses
• June 2012 - The Final Work Plans (FWPs) for clothianidin and thiamethoxam
{Clothianidin Final Work Plan for Registration Review and Thiamethoxam Final Work
Plan for Registration Review) were issued. During the 60-day public comment period for
the clothianidin and thiamethoxam PWPs, the agency received 175 and 14 public
comments, respectively. The clothianidin and thiamethoxam FWPs included corrections
to the list of data requirements needed to conduct a risk assessment to support a proposed
registration review decision pursuant to 40 CFR § 155.53(b).
• July 2012 - The agency announced the availability of a petition received on March 20,
2012 entitled Emergency Petition to Suspend: Clothianidin from the Center for Food
Safety (CFS) acting on behalf of 27 beekeeper and honey producers, and 4 environmental
and consumer organizations. The petition and the agency's partial response to the petition
were posted on July 27, 2012 in a new docket (EPA-HQ-OPP-2012-03 34) and opened a
60-day public comment period that closed on September 25, 2012. The petition's
remaining claims, as well as the 1,363 comments posted in response to the petition, will
be addressed separately from this PID.
• March 2013 - Generic Data Call-Ins (GDCIs) for clothianidin (GDCI-044309-1185) and
thiamethoxam (GDCI-060109-1309) were issued for data needed to conduct the
registration review risk assessments. For both clothianidin and thiamethoxam, all data
requirements have either been satisfied or waived; there are no outstanding GDCI
requirements.
• January 2017 - The agency announced the availability of the Preliminary Bee Risk
Assessment to Support the Registration Review of Clothianidin and Thiamethoxam for a
60-day public comment period.
• December 2017 - The agency announced the availability of the following assessments to
support Registration Review for a 60-day public comment period:
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o Clothianidin. Draft Human Health Risk Assessment in Support of Registration
Review. September 7, 2017.
o Thiamethoxam. Draft Human Health Risk Assessment in Support of Registration
Review. December 5, 2017.
o Clothianidin. Occupational and Residential Exposure Assessment for Registration
Review. September 7, 2017.
o Clothianidin - Drinking Water Exposure Assessment for Registration Review of
All Registered Uses. July 12, 2017.
o Clothianidin Acute and Chronic Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for Registration Review. August 31, 2017.
o Thiamethoxam: Tier IIDrinking Water Exposure Assessment to Support
Registration Review. July 13, 2017.
o Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking
Water) Exposure Assessments for Registration Review. August 31, 2017.
o Clothianidin - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review. November 27, 2017.
o Thiamethoxam - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review. November 29, 2017.
o Biological and Economic Analysis Division (BEAD) Response to Public
Comments Submitted in Response to BEAD's Assessment entitled "Benefits of
Neonicotinoid Seed Treatments to Soybean Production. " December 5, 2017.
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Cotton. November 21, 2017.
o Benefits of Neonicotinoid Insecticide Use in Pre-Bloom and Bloom Periods of
Citrus. November 21, 2017.
• January 2020 - The agency is now announcing the availability of the PID and the Final
Bee Risk Assessment to Support the Registration Review of Clothianidin and
Thiamethoxam in the clothianidin and thiamethoxam dockets for a 60-day public
comment period. Along with the PID, the following documents are also being posted to
the clothianidin and/or thiamethoxam dockets:
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 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.
o Benefits and Impacts of Potential Mitigation for Neonicotinoid Seed Treatments
on Small Grains, Vegetables, andSugarbeet Crops. August 30, 2018.
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.
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o Benefits of NeonicotinoidInsecticide Use in Berries (Strawberry, Caneberry,
Cranberry, and Blueberry) and Impacts of Potential Mitigation. December 6,
2019.
o Benefits of Neonicotinoid Insecticide Use in Cucurbit Production and Impacts of
Potential Risk Mitigation. December 11, 2019.
o Benefits of Neonicotinoid Insecticides Usage in Grapes and Impacts of Potential
Mitigation. October 23, 2019.
o Clothianidin (044309) Screening Level Usage Analysis (SLUA). July 8, 2019.
o Estimate of Area Treated per Day for Insecticides in Poultry Houses and Amount
of Clothianidin Handled per Day When Using a Mechanically Pressurized
Handgun. July 9, 2019.
o Review of "The Value of Neonicotinoids in North American Agriculture "prepared
by Aglnfomatics, LLC, for Bayer CropScience L.P., Mitsui Chemicals Agro, Inc.,
Syngenta Crop Protection, LLC, and Valent U.S.A. LLC. November 4, 2019.
o Review of "The Value of Neonicotinoids in Turf and Ornamentals" prepared by
Aglnfomatics, LLC for Bayer CropScience, Mitsui, Syngenta, and Valent.
December 11, 2019.
o Thiamethoxam (060109) Screening Level Usage Analysis (SLUA). July 25, 2019.
o Usage and Benefits of Neonicotinoid Insecticides in Rice and Response to
Comments. April 22, 2019.
o Usage, Pest Management Benefits, and Possible Impacts of the Potential
Mitigations of the Use of Four Nitroguanidine Neonicotinoids in Pome Fruits
(Apple, Pear). December 11, 2019.
o Clothianidin. Response to Comments on HED 's Draft Human Health Risk
Assessment in Support of Registration Review, and an Updated Poultry House
Assessment. October 30, 2019.
o Thiamethoxam. Revised Response to Comments on the Thiamethoxam Human
Health Draft Risk Assessments for Registration Review. January 14, 2020.
o EFED Response to Public Comments Common to the Preliminary Pollinator and
Preliminary Non-Pollinator Registration Review Risk Assessments Across the
Four Neonicotinoid Pesticides (Imidacloprid, Thiamethoxam, Clothianidin, and
Dinotefuran). January 6, 2020.
o Comparative analysis of Aquatic Invertebrate Risk Quotients generatedfor
neonicotinoids using Raby et al. (2018) toxicity data. January 7, 2020.
o Clothianidin: Non-pollinator Addendum and Chemical-specific Response to
Comments Document for Public Comments Received on the Registration Review
Preliminary Pollinator and Preliminary Non-pollinator Risk Assessments.
January 8, 2020.
o Thiamethoxam: Addendum to the Non-Pollinator Draft Risk Assessment (DRA)
and Response to Public Comments Received on the Bee and Non-Pollinator
DRAs. January 6, 2020.
o Attachment 1 to the Neonicotinoid Final Bee Risk Assessments: Tier II Methodfor
Assessing Combined Nectar and Pollen Exposure to Honey Bee Colonies. January
14, 2020.
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o Attachment 2 to the Neonicotinoid Final Bee Risk Assessments: Residue Bridging
Analysis of Foliar and Soil Agricultural UsesofNeonicotinoids. January 14,
2020.
o Attachment 3 to the Neonicotinoid Final Bee Risk Assessments: Residue Bridging
Analysis for Foliar and Soil Non-Agricultural Uses of Neonicotinoids. January 14,
2020.
o Attachment 4 to the Neonicotinoid Final Bee Risk Assessments: Residue Bridging
Analysis for Seed Treatment Uses of Neonicotinoids. January 14, 2020.
o NOTE TO READER: Documents Supporting the Registration Review of
Clothianidin. January 17, 2020.
o NOTE TO READER: Documents Supporting the Registration Review of
Thiamethoxam. January 17, 2020.
B. Summary of Public Comments on the Draft Risk Assessments and Agency
Responses
As specified in section I. A., the clothianidin and thiamethoxam risk assessment documents were
released in conjunction with two separate comment periods in 2017. The combined preliminary
bee risk assessment for clothianidin and thiamethoxam was published on May 25, 2017 for a
public comment period ending on July 24, 2017. The draft human health and non-pollinator
ecological risk assessments for clothianidin and thiamethoxam, as well as various supporting
benefits-related registration review documents, published on December 21, 2017 for a 60-day
public comment period, which was extended by an additional 60 days, totaling 120 days in
length and ending on April 21, 2018.
Across these two comment periods, the agency received a total of 996 distinct public comments.
In addition, the comments included approximately 400,000 mass mailer campaign submissions.
Comments were submitted by various individuals, organizations, and companies. Comments of a
broader regulatory nature, and the agency's responses to those comments, are provided in the
memorandum Response from OPP's Pesticide Re-evaluation Division to Comments on the Draft
Risk Assessments of the 4 Nitroguanidine-substituted Neonicotinoid Insecticides. Responses to
comments on the topics of neonicotinoid benefits, ecological effects and human health effects are
captured in the following documents:
• 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 Assessed for Neonicotinoid Insecticides. December 23,
2019.
• Clothianidin. Response to Comments on HED 's Draft Human Health Risk Assessment in
Support of Registration Review, and an Updated Poultry House Assessment. October 30,
2019.
• Thiamethoxam. Revised Response to Comments on the Thiamethoxam Human Health
Draft Risk Assessments for Registration Review. January 14, 2020.
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• EFED Response to Public Comments Common to the Preliminary Pollinator and
Preliminary Non-Pollinator Registration Review Risk Assessments Across the Four
Neonicotinoid Pesticides (Imidacloprid, Thiamethoxam, Clothianidin, and Dinotefuran).
January 6, 2020.
• Clothianidin: Non-pollinator Addendum and Chemical-specific Response to Comments
Document for Public Comments Received on the Registration Review Preliminary
Pollinator and Preliminary Non-pollinator Risk Assessments. January 8, 2020.
• Thiamethoxam: Addendum to the Non-Pollinator Draft Risk Assessment (DRA) and
Response to Public Comments Received on the Bee and Non-Pollinator DRAs. January 6,
2020.
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.
Comments Submitted by Syngenta Regarding the Thiamethoxam Draft Human Health
Risk Assessment in EPA-HQ-OPP-2011-0581-0227
Comment: Syngenta noted that the Cruiser 5FS (100-941) label currently includes the following
use restriction, 'Do not apply more than 38 gallons of Cruiser 5FS per 8-hour day for seed
treatments utilizing an open system,' and requested the EPA to include this restriction in the risk
assessment for the liquid product, open system seed treatment scenarios.
EPA Response: The agency agrees that the seed treatment exposure calculations using
application rates from EPA Reg. # 100-941 should also include the gallons per day restriction
noted on the label. However, the agency identified labels (e.g., EPA Reg. # 100-1184) that did
not include a gallons per day restriction. Additionally, the agency determined risks of concern for
seed crop uses (specifically field, pop and sweet corn) identified on these labels, even when the
maximum personal protection equipment (PPE; double-layer clothing and gloves and a
respirator) were considered. As a result, the agency is proposing a requirement that commercial
facilities perform thiamethoxam corn seed treatments only in closed loading systems. For more
information, please refer to Section III.A.l and IV.A.3 of this PID, as well as Thiamethoxam.
Revised Response to Public Comments on the Thiamethoxam Human Health Draft Risk
Assessment for Registration Review, available in the thiamethoxam docket.
Comment: Syngenta noted that the agency's occupational risk assessment for onion seed
handlers used an onion seed throughput rate of 5,000 lb. seed treated/day. This value is
inconsistent with EPA's SOP 15.1, where the onion seed throughput rate is defined as 3,000 lb.
seed treated/day. The SOP value is also consistent with throughput rate of 3,000 lb. seed
treated/day EPA used for onions in the Clothianidin. Draft Human Health Risk Assessment in
Support of Registration Review. Based on this finding, Syngenta asked the agency to refine the
thiamethoxam assessment to align with EPA's SOP and the clothianidin assessment.
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EPA Response: The agency agrees that the value of 3,000 lbs. seed treated/day should have
been used for the assessment of onion seed. After refining the assessment, the agency determined
that there are no risks of concern for activities associated with treating onion seed (margin of
errors (MOEs) range from 130 to 950; LOC = 100).
Comment: Syngenta noted that the seeding rate of 4 lb. seed/A for bulb onions should have been
used in the risk assessment.
EPA Response: The agency agrees that the seeding rate of 4 lbs. seed/A, which results in 320
lbs. seed planted/day, should have been used for the assessment of onion seed. After refining the
model, the agency determined that there are no risks of concern for activities associated with
planting onion seed.
Comment: Syngenta noted the Cruiser 5FS (100-941) and Cruiser Maxx Rice (100-1369) labels
currently include the following use restriction, 'Do not exceed 120 lb. seed per acre,' and
requested this maximum rate be used in the agency's risk assessment.
EPA Response: The agency agrees that the identified labels include a restriction of 120 lbs.
seed/A for rice. After modifying the rate used, based on this restriction, the agency determined
that there are no risks of concern for activities associated with rice seed.
Comment Submitted by ELANCO Regarding Thiamethoxam's Draft Human Health Risk
Assessment (EPA-HQ-OPP-2011-0581-0233)
Comment: ELANCO expressed concerns over an occupational exposure scenario in the draft
human health risk assessment for thiamethoxam. The agency modeled the
mixer/loader/applicator exposure scenario for dry flowable formulations via mechanically
pressurized handgun (for poultry/livestock/horse barn sites) using an assumption of 1,000 gallons
of product application volume per day. ELANCO did not believe the assumption of 1,000
gallons/day of product applied by mechanically pressurized handgun for these sites reflects
actual use practices and asked the agency to refine this assessment.
EPA Response: The agency agrees that since the product label specifies spot treatment of
poultry houses only, the assumption of 1,000 gallons/day is an overestimate for the
mechanically-pressurized handgun scenario. The agency updated the area treatment assumptions
for poultry houses and determined that 12,300 sq. ft. for a perimeter/feed line treatment of one
house is appropriate. The agency also determined that the maximum number of poultry houses
treated by one worker per day is 10, which resulted in a maximum area of 123,000 sq. ft.
feedline/perimeter treated per day.
Using these refined assumptions for both clothianidin and thiamethoxam, the agency determined
that the risk estimates changed substantially. For clothianidin, there are no longer risks of
concern for poultry house treatments (MOEs range from 370 to 69,000), though there are still
risks of concern for other livestock housing scenarios. For thiamethoxam, there is no risk of
concern to mixers/loaders/applicators of dry flowable (DF) formulations using a mechanically-
pressurized handgun in poultry houses with PPE (single-layer clothing and gloves, and a
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respirator; MOE = 160). However, the refined assessments identified new exceedances for
mixers/loaders/applicators of DF formulations of thiamethoxam using a backpack sprayer, even
if the maximum PPE is considered (e.g., double-layer of clothing and gloves, and a respirator;
MOE = 75). For more detailed information, refer to Section III. A. 1 of this PID, and Estimate of
Area Treated per Day for Insecticides in Poultry Houses and Amount of Clothianidin Handled
per Day When Using a Mechanically Pressurized Handgun, Thiamethoxam. Revised Response to
Public Comments on the Thiamethoxam Human Health Draft Risk Assessment for Registration
Review; and Clothianidin. Response to Comments on HED 's Draft Human Health Risk
Assessment in Support of Registration Review, and an Updated Poultry House Assessment;
available in the dockets.
Comment Submitted by the Massachusetts Office of the Attorney General (EPA-HQ-OPP-
2011-0920-0725):
Comment: The Massachusetts Office of the Attorney General (MA-OAG) expressed concerns
regarding risks to pollinators from residential homeowner applications of neonicotinoids on
gardens, lawns and ornamentals. MA-OAG also highlighted that many retailers have voluntarily
committed to phasing out the sale of plants and other products containing neonicotinoid
insecticides. MA-OAG suggests that the agency severely curtail the use of neonicotinoids.
EPA Response: The agency recognizes the potential risks to pollinators from homeowner
applications of neonicotinoids on gardens, lawns and ornamentals. In response, the agency is
proposing to require advisory label language that states, "Intended for use by professional
applicators". Please refer to Section IV. A of this PID for additional details regarding the
proposed label changes.
Comments Submitted Concerning the Preliminary Pollinator Risk Assessments:
The agency also received a number of comments regarding the preliminary pollinator risk
assessments, including those concerning the scientific methodology or rationale in these
assessments. These comments were considered in the preparation of the final pollinator risk
assessments. The agency's responses can be found below. These comments were received from
Academia, 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 Pollinator Stewardship Council (PSC), the San Francisco Estuary Institute (SFEI), the
University of California - Riverside (UCR), the University of California - San Diego (UCSD),
the United States Department of Agriculture (USDA), and Xerces Society for Invertebrate
Conservation (XSIC).
For a more comprehensive account of the comments related to the preliminary pollinator risk
assessments, including those summarized in this PID, refer to EFED Response to Public
Comments Common to the Preliminary Pollinator and Preliminary Non-Pollinator Registration
Review Risk Assessments Across the Four Neonicotinoid Pesticides (Imidacloprid,
Thiamethoxam, Clothianidin, and Dinotefuran), Clothianidin Non-pollinator Addendum and
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Chemical-specific Response to Comments Document for Public Comments Received on the
Registration Review Preliminary Pollinator and Preliminary Non-pollinator Risk Assessments
and Thiamethoxam: Addendum to the Non-Pollinator Draft Risk Assessment (DRA) and
Response to Public Comments Received on the Bee and Non-Pollinator DRAs, which are
available in the public dockets.
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: EPA relies on the best available science at the time of conducting its
assessments. In the risk assessment process, numerous studies are considered and evaluated for
inclusion in the assessments based on the agency's open literature guidance. Open literature
studies that meet the guidance criteria are then selected for inclusion in the risk assessments. The
selected studies are then weighted based on the scientific evaluation. EPA acknowledges the
growing body of studies/data/methodologies and has considered additional studies in the final
pollinator assessments that were brought to the agency's attention as comments received on the
preliminary pollinator assessments.
Summary of Comments (Academia, BK, CBD, CFS, CLA, DBG, NRDC, NWF, PSC,
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: 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 initial registrations for the four nitroguanidine-substituted neonicotinoids
were not concurrent, and, as a result, the registration review schedule for these chemicals were
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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 no
observed adverse effect concentration (NOAEC; CLA, NCGA). In addition, the USDA had
several specific comments on use of the bee bread method (e.g., unvetted methodology,
seasonality, carbohydrate and protein tracking, foraging assumptions, etc.) to evaluate pollen
exposure in the clothianidin and thiamethoxam preliminary bee risk assessments. For more detail
on USDA's concerns, reference EPA-HQ-OPP-2011-0865-0220.
EPA Response: Based on the public comments received, and new data available, including 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 IIMethodfor 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 by Syngenta Regarding Pollen Residues Used in the Preliminary Bee
Risk Assessment (EPA-HQ-OPP-2011-0581-0075):
Comment: Syngenta expressed concerns that the canola study (MRID 49819502) cited in the
Preliminary Bee Risk Assessment to Support the Registration Review of Clothianidin and
Thiamethoxam did not effectively identify the source (soil vs. treated seeds) of thiamethoxam
residues in pollen. Syngenta was also concerned that the chronic EECs were based on a single
sampling interval. Syngenta requested that the agency use the pollen and nectar residue data
from another canola study (MRID 49775702) to refine the bee risk assessment.
EPA Response: The agency updated the seed treatment risk assessment analysis to include
MRID 49775702. Please refer to the Final Bee Risk Assessment to Support the Registration
Review of Clothianidin and Thiamethoxam, available in the clothianidin and thiamethoxam
dockets.
Comments Submitted Concerning the Preliminary Non-Pollinator Risk Assessments:
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The agency received numerous comments in response to the preliminary non-pollinator risk
assessments conducted for the four nitroguanidine-substituted neonicotinoids, including
comments concerning the scientific methodology or rationale in these assessments. These
comments were considered in the preparation of the final non-pollinator risk assessments. These
comments were received from the AVAAZ, the Bay Area Clean Water Agencies (BACWA),
Bayer CropScience, the California Department of Pesticide Regulation (CDPR), CropLife
America (CLA), the San Francisco Bay Regional Water Quality Control Board (SFBRWQCB),
the Vermont Agency of Agriculture Food and Markets (VAAFM), and Xerces Society for
Invertebrate Conservation (XSIC). The agency's response can be found below.
For a more comprehensive account of the comments related to the preliminary non-pollinator
risk assessments and their responses, including those summarized in this PID, refer to EFED
Response to Public Comments Common to the Preliminary Pollinator and Preliminary Non-
Pollinator Registration Review Risk Assessments Across the Four Neonicotinoid Pesticides
(Imidacloprid, Thiamethoxam, Clothianidin, andDinotefuran), Clothianidin Non-pollinator
Addendum and Chemical-specific Response to Comments Document for Public Comments
Received on the Registration Review Preliminary Pollinator and Preliminary Non-pollinator
Risk Assessments and Thiamethoxam: Addendum to the Non-Pollinator Draft Risk Assessment
(DRA) and Response to Public Comments Received on the Bee and Non-Pollinator DRAs, which
are available in the public dockets.
Summary of Comment (CDPR and VAAFM): CDPR asserted that the neonicotinoid
assessments did not adequately consider the potential runoff from treated seeds planted greater
than 2 cm below the soil surface as the EPA's Pesticide Water Calculator (PWC) model used in
the assessment does not quantitatively estimate pesticide residues from treated seeds planted
below 2 cm (EPA-HQ-OPP-2008-0844-1116). However, CDPR referenced monitoring data
(Hladik et. al., 2014) that found that pesticide detections in surface water can be associated with
rainfall events following planting of treated seeds, suggesting a link between seed treatments and
pesticide detections in surface water. It was noted, though, that this study does not identify the
depth at which the seed treatments in question were planted. Additionally, VAAFM reported
maximum concentrations of neonicotinoids in the streams receiving effluent from tile drains (see
EPA-HQ-OPP-2008-0844-1175 for additional details). CDPR suggested employing refined
future modeling efforts to include soil runoff modeling to account for subsurface flow such as
tile drains commonly used in agriculture.
EPA Response: The agency recently re-evaluated its surface water modeling for seed
treatments. The agency no longer models applications "at depth", which could potentially
overlook pesticide residues in runoff from treated seeds planted at depths below 2 cm. Instead,
the agency has elected to use the "increasing with depth" application of the PWC model, which
assumes that some portion of the applied chemical will be available to runoff, even when planted
at depth. These assumptions were implemented in the models included in the comparative
aquatic neonicotinoid risk assessment and associated documents, which identified acute and
chronic risk exceedances for aquatic invertebrates (see Section III.B.l of this PID).
The agency is proposing label language to mitigate potential risks from runoff. The proposed
label language covers treated seeds, but also includes statements for spray and foliar
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applications. For a detailed description of the proposed label language please refer to Sections
IV. A.7 and IV. A. 8, and Appendix B.
Summary of Comments (AVAAZ, BACWA, CDPR, CLA, SFBRWQCB, XSIC): Several
commenters (EPA-HQ-OPP-2008-0844-1192, EPA-HQ-OPP-2011-0865-1068, EPA-HQ-OPP-
2008-0844-1116) assert that ample evidence exists in the literature to show that relatively small
concentrations of neonicotinoids can trigger harmful effects; that invertebrates are harmed at
levels well below the current aquatic life benchmarks, and that these benchmarks should be
revised. The commenters also felt that the following studies should be considered in the
assessments:
• Maloney, E. M., Morrissey, C. A., Headley, J. V., Peru, K. M., & Liber, K. (2017).
Cumulative toxicity of neonicotinoid insecticide mixtures to Chironomus dilutus under
acute exposure scenarios. Environmental Toxicology and Chemistry, 36(11), 3091-3101.
• Miles, J. C., Hua, J., Sepulveda, M. S., Krupke, C. H., & Hoverman, J. T. (2017). Effects
of clothianidin on aquatic communities: Evaluating the impacts of lethal and sublethal
exposure to neonicotinoids. PloS One, 12(3), e0174171.
• Raby, M., Nowierski, M., Perlov, D., Zhao, X., Hao, C., Poirier, D. G., & Sibley, P. K.
(2018). Acute toxicity of 6 neonicotinoid insecticides to freshwater invertebrates.
Environmental Toxicology and Chemistry, 37(5), 1430-1445.
Conversely, CLA (EPA-HQ-OPP-2008-0844-1562) asserted that the application of the most
conservative endpoint to assess risk to all aquatic invertebrates is overly conservative and does
not account for diversity of aquatic invertebrate communities.
EPA Response: The agency 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 et.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 the study does not change 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 Syngenta Regarding the Avian Endpoints Used in the Preliminary
Aquatic and Non-Pollinator Risk Assessment for Thiamethoxam (EPA-HQ-OPP-2011-
0581-0228):
Comment: Syngenta noted that the endpoints reported for the mallard reproduction study were
expressed in milligrams of active ingredient per kilogram of bodyweight (mg a.i./kg-bw), but
should have been reported in milligrams of active ingredient per kilogram of diet (mg a.i./kg-
diet; p. 82 of Thiamethoxam - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review). Syngenta asked that the agency
review the reported figures and provide the daily dose calculations.
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EPA Response: The agency confirmed that there was a typographical error in the endpoints
reported for the mallard reproduction study, and that these figures should have been expressed as
mg a.i./kg-diet. Please refer to Thiamethoxam: Addendum to the Non-Pollinator Draft Risk
Assessment (DRA) and Response to Public Comments Received on the Bee and Non-Pollinator
DRAs, available in the thiamethoxam docket, for the daily dose conversion calculation and
further details.
II. USE AND USAGE
Clothianidin
Clothianidin is a nitroguanidine-substituted neonicotinoid insecticide, which was first registered
for use as pesticide in the United States in 2003. Clothianidin is used to target a wide variety of
insect pests including, but not limited to piercing sucking pests such as aphids, mealybugs,
sharpshooters, Asian citrus and pear psyllids and stinkbugs; coleopteran pests such as corn
rootworm, billbugs, white grubs, and plum curculio; and a variety of sporadic pests such seed
maggots and symphylans. Products containing clothianidin are formulated as granular, dust, seed
treatment, solid agar, pressurized liquid, emulsifiable concentrate, soluble concentrate, and
ready-to-use solutions on a variety of agricultural and non-agricultural use sites. Agricultural
sites include vegetable crops, tree fruits, tree nuts, and field crops. Applications can also be made
to poultry litter manure in chicken houses for darkling beetles and other poultry houses pests and
later utilized as outdoor fertilizer. Non-agricultural uses include turf and ornamental plants, and
indoor and outdoor residential, commercial, and industrial sites.
The largest agricultural use for clothianidin, in terms of lbs. a.i. applied, has been in the form of
seed treatments. On average, between 2005 and 2014, over 1,400,000 lbs. a.i. of clothianidin
were used annually for seed treatments on various field crops including corn, cotton, soybean,
and wheat.1 There are also seed treatments registered for various vegetable crops. More recent
data on seed treatment usage are not available.
From 2007-2016, soil and foliar usage (together) averaged about 300,000 lbs. a.i.2, applied to
approximately 400 million acres annually.3 Agricultural sites with the highest usage of
clothianidin in average pounds applied per year are cotton (10,000), rice (6,000), and soybean
(5,000).2 The highest percent crop treated (PCT) values are reported for table grapes (20%),
broccoli (15%), and figs (10%).
The agency has limited usage data on non-agricultural use sites. In 2016, approximately 9,000
lbs. a.i. of clothianidin was used by pest management professionals for outdoor pest control {i.e.,
1 Clothianidin (044309) Screening Level Usage Analysis (SLUA), December 30, 2015.
2 Clothianidin (044309) Screening Level Usage Analysis (SLUA), July 8, 2019
3 Agricultural Market Research Data (AMRD). 2007-2017.
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turf and ornamental plants, including in residential areas) and over 4,000 lbs. a.i. for indoor pest
control.4
Thiamethoxam
Thiamethoxam was first registered for use as a pesticide in the United States in 1999.
Thiamethoxam is commonly used to target piercing sucking pests such as aphids, leafhoppers,
and whitefly in addition to certain hard to kill pests such as pepper weevil and thrips. Products
containing clothianidin are formulated as wettable powder, dust, granular, microencapsulated,
solid agar, soluble concentrate/solid, flowable concentrate, emulsifiable concentrate, and ready-
to-use solutions. Thiamethoxam is registered to control various insects on a wide variety of
agricultural use sites (e.g. field, forage, fruit, spice, and vegetable crops) and non-agricultural use
sites (e.g. in and around residential/domestic dwellings, food handling establishments,
commercial/ institutional/industrial areas, livestock pens, poultry houses, wood or wooden
structures, and transportation vehicles).
As an antimicrobial pesticide, thiamethoxam was also registered for use as a wood preservative,
however, these registrations were cancelled on September 18, 2013.5
The largest agricultural use for thiamethoxam, in terms of lbs. a.i. applied, has been in the form
of seed treatments. On average, between 2005 and 2014, approximately 800,000 lbs. a.i. of
thiamethoxam were used annually for seed treatments on various field crops including corn,
cotton, soybean, potato, and wheat.6 There are also seed treatments registered for various
vegetable crops. More recent data on seed treatment usage are not available.
From 2007-2017, soil and foliar usage (together) averaged about 100,000 lbs. a.i.7, applied to
approximately 1.7 million acres annually.3 Agricultural sites with the highest usage of
thiamethoxam in average pounds applied per year are cotton (36,000 lbs.), soybean (15,000 lbs.),
and potatoes (10,000 lbs.).6 The highest percent crop treated (PCT) values are reported for
grapefruit (30%), lettuce (20%), peppers (20%), and strawberry (20%).
The agency has limited usage data on non-agricultural use sites. Usage of thiamethoxam by pest
management professionals has not been reported in recent years.
III. SCIENTIFIC ASSESSMENTS
A. Human Health Risks
A summary of the agency's human health risk assessments for clothianidin and thiamethoxam
are presented below. The agency used the most current science policies and risk assessment
4 Non-agricultural Market Research Data (NMRD), 2017.
5 78 FR 57379.
6 Thiamethoxam (Q60109) Screening Level Usage Analysis (SLUA), January 26, 2016.
7 Thiamethoxam (Q60109) Screening Level Usage Analysis (SLUA), July 25, 2019.
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methodologies to prepare risk assessments in support of the registration review of clothianidin
and thiamethoxam. For additional details on the human health assessment for clothianidin, see
the Clothianidin. Draft Human Health Risk Assessment in Support of Registration Review,
available in the public docket for clothianidin: EPA-HQ-OPP-2011-0865. For additional details
on the human health assessment for thiamethoxam, see the following documents: Thiamethoxam.
Draft Human Health Risk Assessment for Registration Review; and Thiamethoxam Registration
Review: Human Health Scoping Information Regarding the Wood Preservative Uses (Post Peer
Review Update). Both documents are available on regulations.gov in the thiamethoxam docket:
EPA-HQ-OPP-2011-0581.
1. Risk Summary and Characterization
The toxicology databases for both clothianidin and thiamethoxam are complete. Studies for
clothianidin were performed via the oral, inhalation, and dermal routes of exposure. For
thiamethoxam, studies were only conducted for oral and dermal routes of exposure, where the
agency's Hazard and Science Policy Council (HASPOC) found that the inhalation toxicity study
could be waived based on a weight-of-evidence (WOE) approach (TXR# 0057630, M. Lewis,
09/22/17). The risk assessments for each of these two active ingredients use conservative
assumptions, and the most sensitive endpoint from the respective toxicity databases, and are
therefore protective of all potential reproductive, developmental and neurotoxic effects. Given
the completeness of the toxicity database; clear reproductive and developmental NOAELs; and
protective neurotoxic endpoints, the agency determined that reductions of the Food Quality
Protection Act (FQPA) safety factors to IX are appropriate for both clothianidin and
thiamethoxam. In addition, both clothianidin and thiamethoxam are classified as "not likely to be
carcinogenic to humans" and therefore no quantitative cancer risk assessment was conducted for
either chemical.
There are no adverse effects observed in the route-specific dermal toxicity studies up to the limit
dose in any tissue or organ for either clothianidin or thiamethoxam. However, since increased
susceptibility was observed, oral points-of-departure (PODs) were selected for dermal exposure
scenarios because the dermal toxicity studies did not evaluate developmental or reproductive
endpoints. For clothianidin, oral PODs were also selected for the inhalation routes of exposure
because the inhalation toxicity study did not evaluate developmental or reproductive endpoints.
For thiamethoxam, a route-specific subchronic inhalation study was not recommended (TXR#
0057630, M. Lewis, 09/22/17).
Residues of thiamethoxam are expressed in terms of the combined residues of the insecticide
thiamethoxam and its metabolite CGA-322704, also referred to as clothianidin; A-[(2-chloro-
thiazol-5-yl)methyl]-A"-methyl-A"'-nitro-guanidine. As noted previously, clothianidin is a
registered pesticide active ingredient but is also a major degradate of thiamethoxam. The agency
conducted separate risk assessments for thiamethoxam and for clothianidin, which included
residues resulting from application of thiamethoxam.
There were no dietary, residential, aggregate or bystander risks of concern identified for either
clothianidin or thiamethoxam. However, the agency's human health risk assessments identified
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potential risks of concern for certain occupational handler scenarios, which is described in
further detail below, as well as in Clothianidin. Draft Human Health Risk Assessment in Support
of Registration Review and Thiamethoxam. Draft Human Health Risk Assessment for
Registration Review, which are available in the chemical-specific docket.
Clothianidin
Dietary Risk
There are no acute or chronic dietary (food and drinking water combined) exposure estimates of
concern, as they are all below the agency's level of concern {i.e., 100% of the acute or chronic
population adjusted dose (aPAD or cPAD, respectively)) using conservative assumptions such as
100% crop treated for all commodities, tolerance-level residues (acute), field-trial-average
residues (chronic), high-end estimates for drinking water derived using the highest application
rates and modeling based on the most vulnerable areas. The clothianidin acute risk estimate for
the most highly exposed population subgroup, children 1-2 years old, was 29% of the aPAD.
The chronic dietary estimate for the most highly exposed population subgroup (infants) was 9%
of the cPAD.
Residential Handler, Residential Post-Application, and Non-Occupational Spray Drift Risk
There are no residential risk estimates of concern for handlers, as all scenarios (combined dermal
and inhalation) resulted in margins of exposure (MOEs) greater than the EPA's level of concern
(LOC) of 100, ranging from 460 to 27,000,000. There are also no post-application residential
risks of concern for adults or children; all combined estimates (dermal, inhalation and incidental
oral) are greater than the LOC of 100, with MOEs ranging from 160 to 1,400,000. While there is
the potential for bystander exposure to drift from sprays applied to agricultural areas, exposures
resulting from spray drift were not quantitatively assessed because the turf exposure assessment
is considered to be protective.
Aggregate Risk
There is potential for aggregate exposure to clothianidin from combined exposure through
dietary and residential sources. The EPA assessed potential aggregate risks for all exposure
durations. The acute aggregate assessment is equivalent to the dietary risk assessment which, as
mentioned previously, found no risks of concern. All short-term aggregate exposures are also not
of concern (MOEs range from 150 to 390; LOC = 100). Chronic exposure to clothianidin (i.e.,
continuous exposure for > 6 months) is not expected to occur, therefore, chronic aggregate risk
estimates are equivalent to the dietary risk estimates, which are not of concern.
Occupational Handler and Occupational Post-Application Risk
Except for seed treatment use on corn, there are no agricultural use occupational handler
scenarios that result in risk estimates of concern; MOEs for other agricultural uses range from
510 to 1,200,000 (LOC = 100). The MOE for occupational handlers performing multiple
activities (loading/applying, sewing, bagging, etc) for corn seed treatment is 71 with the
currently label-required personal protective equipment (PPE) of single layer clothing (i.e., long
sleeves and pants) and gloves. With the addition of a respirator, the risk would no longer be of
concern (MOE = 190). All other seed treatment scenarios did not result in risk estimates of
concern, with MOEs ranging from 110 to 250,000.
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Two non-agricultural scenarios resulted in risk estimates of concern (MOEs < LOC of 100). The
first is for mixers/loaders/applicators of liquid formulations via mechanically-pressurized
handguns in poultry houses and other livestock housing (i.e., barns/feedlots), with an MOE of
54. In the 2019 memorandum Clothianidin. Response to Comments on HED's Draft Human
Health Risk Assessment in Support of Registration Review, and an Updated Poultry House
Assessment, the agency updated some of its risk conclusions for non-agricultural use scenarios.
On the basis of updated area treatment assumptions, the agency concluded that there are no
longer occupational risk estimates of concern for use of clothianidin in poultry houses, with risk
estimates (MOEs) ranging from 370 to 69,000 (LOC = 100). However, EPA also noted in the
response-to-comments memo that uses on other livestock housing (i.e., barns/feedlots) are still
assessed assuming the original use assumptions because the updated poultry house treatment area
is not applicable to these scenarios. For scenarios in these other livestock houses, there are
potential risks of concern for barn/feedlot uses with mechanically-pressurized handguns (MOE =
80). The addition of gloves to these use scenarios results in a MOE of 97.
The second non-agricultural scenario is for an applicator treating commercial buildings using
liquid aerosol cans, which resulted in an MOE of 48. Adding gloves and a respirator would raise
the MOE to 140, and the scenario would no longer be of concern. There were no other non-
agricultural scenarios that resulted in risk estimates of concern, with MOEs ranging from 130 to
150,000. In addition, there are no occupational post-application risk estimates of concern, with
all MOEs greater than the LOC of 100.
Thiamethoxam
Dietary Risk
There are no acute or chronic dietary risk estimates of concern for thiamethoxam, as they are all
below 100% of the thiamethoxam aPAD and cPAD, respectively. Children 1-2 years old are
the most highly exposed population subgroup for both acute dietary risk (8% of the aPAD) and
chronic dietary risk (48% of the cPAD).
Residential Handler, Residential Post-Application, and Non-Occupational Spray Drift Risk
There are no residential risk estimates of concern for handlers (combined dermal and inhalation
MOEs range from 770 to 260,000; LOC = 100). There are also no post-application residential
risks of concern for adults or children; all estimates (dermal, inhalation and/or incidental oral
MOEs range from 180 to 9.4 x 108). While there is the potential for bystander exposure to drift
from sprays applied to agricultural areas, exposures resulting from spray drift were not
quantitatively assessed because the turf exposure assessment is considered to be protective.
Aggregate Risk
There is potential for aggregate exposure to thiamethoxam from combined dietary and residential
sources. The EPA assessed potential aggregate risks for all exposure durations. The acute
aggregate assessment is equivalent to the dietary risk assessment, which, as mentioned
previously, identified no risks of concern. There are no short-term aggregate risks of concern
(MOEs range 140 to 610; LOC = 100). Chronic aggregate risk estimates for thiamethoxam are
equivalent to the dietary risk estimates, which are not of concern.
Occupational Risks
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The Thiamethoxam. Draft Human Health Risk Assessment in Support of Registration Review
included an analysis of 92 different agricultural and non-agricultural occupational handler
exposure scenarios. Of those 92 scenarios, 79 are not be of concern (i.e., combined dermal +
inhalation MOEs >100 with baseline attire, or engineering controls in the case of aerial
applications).
For the 13 scenarios where the MOEs do not reach the target LOC of 100:
• Gloves mitigate potential risks of concern for:
o mixing/loading liquid formulations for aerial applications to high-acreage field
crops8 (MOE increases from 98 to 520);
o mixing/loading/applying liquid formulations for crack and crevice (C&C) via
manually-pressurized handwand for applications in warehouses (MOE increases
from 91 to 150);
o mixing/loading/applying liquid formulations for crack and crevice (C&C) via
manually-pressurized handwand for applications in childcare centers, schools and
institutions (MOE increases from 91 to 150);
o mixing/loading/applying liquid formulations for crack and crevice (C&C) via
manually-pressurized handwand for applications in residential living spaces
(MOE increases from 91 to 150);
o mixing/loading/applying liquid formulations for crack and crevice (C&C) via
manually-pressurized handwand for applications to mounds or nests (MOE
increases from 6.7 to 630);
o mixing/loading/applying DF formulations via manually-pressurized handwand to
mounds or nests (MOE increases from 87 to 8,600); and
o mixing/loading/applying DF formulations via mechanically-pressurized handgun
for applications to landscaping trees, shrubs and bushes (MOE increases from 65
to 180).
• Gloves and a respirator would mitigate potential risks of concern for:
o mixing/loading DF formulations for aerial application on sod (MOE increases
from 44 to 200);
o mixing/loading DF formulations for aerial application on high-acreage field crops
(MOE increases from 53 to 250);
o mixing/loading/applying DF formulations via mechanically-pressurized handgun
for poultry-house applications (MOE increases from 57 to 160); and
o mixing/loading/applying liquids with a mechanically-pressurized handgun for
warehouse applications (MOE increases from 55 to 190).
• MOEs do not reach the target LOC for the following scenarios:
o mixing/loading/applying DF formulations via mechanically-pressurized handgun
to poultry /livestock house/horse barn/feed lots (MOE is 29 with double layer of
protective clothing, gloves, and a respirator); and
o commercial seed treatment for corn (field, pop, and sweet), safflower, and
sorghum (MOEs ranged from 13 to 82).
8 High-acreage crops include, but are not limited to barley, wheat, rice, cotton, corn, and other crops where 1,200
acres or more are treated per day.
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During the public comment period on the draft risk assessment, Elanco contended that the
agency's risk estimate was overly conservative because it assumed 1,000 gallons of product
application volume per day.
In the 2019 response-to-comments memorandum Thiamethoxam. Revised Response to Public
Comments on the Thiamethoxam Human Health Draft Risk Assessment for Registration Review,
EPA determined that a treatment assumption of 12,300 ft2 for a perimeter/feed line treatment of
one poultry house, with at most 10 poultry houses treated in a day by one worker, is appropriate
for assessing potential risks from applications in poultry houses with handheld equipment. Using
these updated assumptions, and assuming the use of PPE consisting of gloves and a respirator,
the risk estimate for mixing/loading/applying DF formulations using a mechanically-pressurized
handgun in poultry houses reaches a combined (dermal plus inhalation) MOE of 160, which is
not of concern to the agency.
The response-to-comments memo adds that the revised assumptions for poultry houses also
result in a new risk exceedance for mixing/loading/applying DF formulations of thiamethoxam
using a backpack sprayer. In this poultry house use scenario, the combined MOE for
occupational handler risks is now of concern to the agency even considering maximum PPE
(e.g., double layer of clothing and a respirator; combined MOE = 75).
The agency also received comments from Syngenta that facilitated refinements to some of the
risk calculations presented in the draft human health risk assessment. After incorporating the
volumetric use restriction currently on the label for EPA Reg. #100-941 (Cruiser 5FS) limiting
the gallons of product that may be handled per 8-hour day, EPA found that there are no risks of
concern (i.e., MOEs are above the LOC) for the seed crops listed on this label (including field
corn, popcorn, sweet corn, cotton, flax, mustard, rice, safflower, and sunflower) for all seed
treatment activities. However, other labels exist with corn (field, pop, and sweet) seed treatment
which do not include volumetric use restrictions, and occupational risks for these labels remain
of concern.
Syngenta also provided comments on onion seeding rates. Based on these comments, EPA is
revising its assumptions for onion seed treatment rates, which resulted in no risks of concern for
activities associated with treating onion seed (MOEs range from 130 to 950).
In addition, there are now no risks of concern for activities associated with planting treated onion
seed (MOE= 280).
The EPA has also updated the assumption for the amount of rice seed handled per day. After
incorporating a restriction currently on labels9 capping the allowable amount of rice that may be
planted at 120 lbs. seed/A, the MOE for activities associated with rice seed is no longer of
concern (MOE =120).
9 EPA Reg. numbers 100-941 (Cruiser 5FS) and 100-1369 (Cruiser Maxx Rice).
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Cumulative Risks
EPA has not made a common mechanism of toxicity to humans finding as to clothianidin or
thiamethoxam and any other substance, and they do not appear to produce a toxic metabolite
produced by other substances. Therefore, EPA has not assumed that either clothianidin or
thiamethoxam have a common mechanism of toxicity with other substances.
2. Human Incidents and Epidemiology
The agency reviewed incidents for clothianidin and thiamethoxam using the OPP Incident Data
System (IDS) and the Centers for Disease Control and Prevention/National Institute for
Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for
Occupational Risk Pesticides (SENSOR) databases.
Clothianidin
In Main IDS, from January 1, 2012 to July 13, 2017,17 cases were reported involving
clothianidin, all of which reported multiple active ingredients. For Aggregate IDS, from January
1, 2012 to April 28, 2017, 52 incidents were reported involving clothianidin and were classified
as minor severity.
A query of SENSOR-Pesticides (1998 - 2013) identified four cases involving clothianidin. Of
the clothianidin cases reported, three cases involved multiple active ingredients and the fourth
case involved only clothianidin. One case was classified as moderate severity and three cases
were classified as low severity. All clothianidin cases were occupational in nature.
Based on the continued low frequency of thiamethoxam and clothianidin 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 information available for thiamethoxam and clothianidin
and additional analyses will be conducted if ongoing human incident monitoring indicates a
concern.
Thiamethoxam
In Main IDS, from January 1, 2012 to July 13, 2017, 45 cases were reported involving the active
ingredient thiamethoxam. Of these 45 case reports, thiamethoxam was the only pesticidal active
ingredient in nine incidents, each classified as moderate severity. The remaining 36
thiamethoxam incidents reported involved multiple active ingredients. In Aggregate IDS, from
January 1, 2012 to July 13, 2017, 110 thiamethoxam incidents were reported. These
thiamethoxam incidents were all classified as minor severity.
A query of SENSOR-Pesticides (1998 - 2013) identified 16 cases involving thiamethoxam.
Eleven cases involved multiple active ingredients and five cases involved a single active
ingredient. One case was high in severity, three cases were moderate in severity, and 12 cases
were low in severity. Four of the cases were coded as occupational in nature. The one high
severity thiamethoxam incident occurred in Michigan in 2011 and involved an adult male who
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was not wearing the required PPE (gloves). He experienced a rash that lasted for more than 1.5
months and swelling in his neck that altered his voice.
3. Tolerances
Clothianidin
Tolerances for residues of clothianidin, including its metabolites, are established in 40 CFR
§180.586. The tolerance expression for clothianidin contains a coverage and compliance
statement and is therefore in accordance with current practices. There are clothianidin tolerance
listings for several crop groups that have undergone revisions including Crop Groups/Subgroups
4, 5, 8 and 14, and these changes are summarized in Table 1 below. The analytical reference
standard for clothianidin expired in April 2018, and the registrant is responsible for maintaining
reasonable amounts of this standard as long as tolerances remain published in 40 CFR §180.586.
See Section 2.2.1 of the Clothianidin. Draft Human Health Risk Assessment in Support of
Registration for directions on submitting an analytical reference standard for clothianidin.
There is a time-limited tolerance for rice which expired in 2012 for residues of clothianidin on
rice seed, which the agency proposes to remove from the 40 CFR 180.586 (a) (2), because there
is a permanent tolerance already for clothianidin on rice (grain). In addition, there are
opportunities for international harmonization with the tolerances for clothianidin. Some listings
are harmonized with Canadian MRLs and others with Codex MRLs. In the case of updates to
Crop Groups 4 and 5, some commodities have moved to different crop groups. EPA recommends
revising US tolerances to harmonize with Codex MRLs for subgroup 13-07H, Group 15 (except
rice), and Group 16 (except rice straw). Additionally, EPA is proposing eliminating trailing zeros
listed in tolerances consistent with agency policy. For a full list of proposed clothianidin
tolerance changes, please refer to Appendix E Table 1 in this PID.
Tsihle 1: ('lolhiiiniilin 40 ( I k § 180.586: Siiinniiirv of Proposed Tolcrsincc Actions
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Tsihle 1: ('lolhiiiniilin 40 ( I k § 180.586: Siiinniiirv of Proposed Tolcrsincc Actions
( lllTCllI ( oillllkidils I.Nlim
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eliminating trailing zeros listed in tolerances consistent with agency policy. For a full list of
proposed thiamethoxam tolerance changes, please refer to Appendix E Table 2 in this PID.
Tsihlc 2: rhiiiiiK'thoxiiin 40 C'l-'k $ 180.565
: Sn in in ii r\ of Proposed TolcmiHT Actions
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Separate listings for:
Leafy greens Subgroup 4-16A,
Vegetable, leafy, except
Brassica, Group 4
4.0
Leafy petiole vegetable Subgroup
22B,
Celtuce, and
Florence fennel
4
Separate listings for:
Brassica, head and stem,
Subgroup 5A
4.5
Vegetable, Brassica, head and stem,
Group 5-16; and
Kohlrabi
4.5 (No change)
Brassica, leafy greens,
Subgroup 5B
3.0
Brassica leafy greens Subgroup 4-16B
3
Vegetables, fruiting,
Group 8
0.25
Vegetables, fruiting, Group 8-10
0.25 (No change)
Fruit, citrus, Group 10
0.4
Fruit, citrus, Group 10-10
0.4 (No change)
Fruit, pome, Group 11
0.2
Fruit, pome, Group 11-10
0.2
Fruit, stone, Group 12
0.5
Fruit, stone, Group 12-12
0.5
Nut, tree, Group 14
0.02
Nut, tree, Group 14-12
0.02
Pistachio
0.02
Remove
—
Caneberry, Subgroup 13-
07A
0.35
Caneberry, Subgroup 13-07A (No
change)
0.5
4. Human Health Data Needs
The human health database is complete for both clothianidin and thiamethoxam, and there are no
data deficiencies at this time. As noted in the thiamethoxam draft human health risk assessment
for registration review, an inhalation toxicity study is not available for thiamethoxam; however,
the agency's HASPOC recommended, based on a WOE approach, that the study could be waived
(TXR# 0057630, M. Lewis, 09/22/17).
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 clothianidin and thiamethoxam. For additional details on the
ecological assessment for clothianidin and thiamethoxam, see the following documents, which
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are available in the public dockets for clothianidin and thiamethoxam EPA-HQ-OPP-2011-0865
and EPA-HQ-OPP-2011-0581) at www.regulations.gov.
o Clothianidin - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review,
o Thiamethoxam - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review,
o Final Bee Risk Assessment to Support the Registration Review of Clothianidin
and Thiamethoxam.
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. After the scientific methods necessary to complete risk assessments for listed species
and their designated critical habitats are finalized, the agency will complete its listed species
assessments for clothianidin and thiamethoxam. See Appendix C for more details. As such,
potential risks for non-listed species only are described below.
1. Risk Summary and Characterization
Both clothianidin and thiamethoxam are water-soluble chemicals with low vapor pressure and
Henry's Law Constants, indicating that these compounds are unlikely to volatilize in field
conditions. Additionally, both active ingredients have low octanol: water partitioning
coefficients, which suggests that clothianidin and thiamethoxam are unlikely to bioaccumulate.
Terrestrial Exposure and Risk - Overview
Thiamethoxam is applied through aerial and ground application methods, which includes
sprayers, chemigation and soil drenching, and seed treatments. Clothianidin is applied via the
same application methods, but also includes basal bark treatments and spot treatments. For
terrestrial wildlife, the agency modeled potential dietary exposure based on consumption of
clothianidin and thiamethoxam residues on food items following spray (foliar or soil)
applications as well as from possible dietary ingestion of residues on treated seeds. For treated
seeds, different seed sizes and planting rates could result in a range of exposures. For
clothianidin, potential dietary exposure was also considered from fields where applied manure
from poultry house operations may contain clothianidin residues resulting in potential
contamination of potential food items (e.g., insects) and/or incidental ingestion of contaminated
soil particles.
Overall, acute risks to avian and mammalian species from foliar and soil treatments of
clothianidin and thiamethoxam appear to be low. Soil incorporation following soil treatments (or
following soil amendment applications of poultry litter with clothianidin residues) decreases
potential risks from this use pattern considerably. Exposures from treated seeds result in the
highest acute and chronic risks to terrestrial organisms. However, the risks vary considerably. A
low number of small treated seeds (e.g. lettuce and sugar beets) are required to reach levels of
concern for smaller birds and mammals because the surface of these seeds have higher
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concentrations of a.i. applied. Also, these smaller seeds are easier for small birds and mammals
to consume because of their small size. However, larger seeds (e.g. corn and soybean) pose far
lower risks to birds and mammals because lower concentrations of a.i. are applied to the seed
surface. Also, the larger size of these seeds prevents smaller birds and mammals from consuming
them.
For terrestrial invertebrates, the primary routes of exposure assessed include contact of bees with
spray droplets and oral ingestion via pollen and nectar. Additionally, exposure can occur from
seed treatment dust. Exposure can vary based on use patterns and the attractiveness of a treated
crop.
Terrestrial and semi-aquatic (i.e. wetland) plant exposure estimates typically include plants that
reside near a use area that may be exposed via runoff and/or spray drift from ground and/or aerial
applications of a pesticide. For clothianidin and thiamethoxam, the agency only modeled the
maximum single foliar (ground) applications (0.4 lbs. a.i./A and 0.265 lbs. a.i./A, respectively) of
each active ingredient to turf and/or ornamentals. Aerial applications are not prevalent based on
clothianidin and thiamethoxam use patterns for turf or ornamentals, and, therefore, are not
considered in these assessments. Risks of thiamethoxam and clothianidin are considered low for
terrestrial and semi-aquatic plants.
Mammals - Risk Estimates
Clothianidin is classified as moderately toxic to mammals on an acute oral exposure basis.
Chronic exposure with the Norway rat (Rattus norvegicus) resulted in effects on growth and
maturation in offspring. The chronic mammalian risk quotients (RQs) calculated for clothianidin
are based on the chronic mammalian rat no observed adverse effect level (NOAEL) of 9.8
mg/kg-bw/day. Thiamethoxam is considered slightly toxic to mammals (LDso = 1563 mg/kg-bw)
on an acute oral basis, and in a chronic exposure reproduction test reduced weight gain was seen
in offspring at 158 mg/kg-bw/day (NOAEL 61 mg/kg-bw/day). Potential risk was evaluated at
three different weight classes of mammal: small (15 g), medium (35 g), and large (1000 g).
Further details on ecological risks are provided below in separate sub-sections for clothianidin
and thiamethoxam.
Clothianidin:
Foliar Applications: There are no acute risks of concern via foliar applications for mammalian
species of any weight class even when assessed using the maximum registered single application
rate of 0.4 lbs. a.i./A (RQs <0.01 - 0.20; LOC = 0.5). Acute RQs are highest for small mammals
feeding on short grass.
There are no chronic mammalian LOC exceedances on a chronic dietary basis for all application
rates (highest RQ = 0.49; LOC = 1.0), but there are exceedances for dose-based RQs based on
single application rates. Risk estimates rose with increases in the modeled application rate. For
single applications at the 0.1 lbs. a.i./A rate, there was only a marginal exceedance of the chronic
LOC (1.0) for small mammals consuming short grass (RQ = 1.06). At that same application rate
but with an assumption of two applications per year, chronic dose-based RQs exceeded the LOC
for small mammals consuming short grass and/or broadleaf plants (RQs = 1.99 and 1.12,
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respectively) as well as medium-sized mammals consuming short grass (RQ = 1.70). Potential
risks of concern are also identified for both small and medium mammals consuming short grass
and/or broadleaf plants (highest RQ = 2.12) at an application rate of 0.2 lbs. a.i./A. At the single
foliar application rate of 0.4 lbs. a.i./A, chronic dose-based risks of concern are identified for all
mammal size classes depending on the dietary item (highest RQ = 4.24), with exception of
fruits/pods/seeds and grains.
Soil Applications'. Based on the acute analysis (LDso/ft2; herein referred to as "area-based
analysis") for soil applications, the acute LOC (0.5) is exceeded for small mammals only at the
highest two application rates assessed: 0.4 lbs. a.i./A (RQ = 0.61), which represents the highest
soil application rate, and 0.49 lbs. a.i./A (RQ = 0.75), which represents residues in fields
following soil amendment applications of manure pulled from clothianidin-treated poultry
houses.
A second way in which the agency assessed potential risks of soil applications of clothianidin to
mammals was by using the upper bound Kenaga EECs in arthropods following soil applications
as a surrogate for potential exposures of likely dietary items following soil exposures. Based on
this analysis, there are no acute risks of concern for mammals (LOC = 0.5; highest RQ = 0.10 for
the scenario of exposed poultry litter used as a soil amendment). However, four chronic risk
estimates exceed the LOC (1.0; highest RQ = 2.04), indicating chronic risks of concern to small-
medium mammals from soil applications at the application rate of 0.4 lbs. a.i./A, as well as
exposure to residues from poultry litter soil amendment applications on agricultural fields (0.49
lbs. a.i./A).
Treated Seed Applications: RQs were calculated for six crops (corn, soybean, cotton, sugar beet
and lettuce) when assessing potential risks to mammals from clothianidin-treated seeds. Modeled
uses were selected to be representative of high-acreage crops (e.g. corn, soybean, cotton), to
provide a range of application rates (e.g. cotton 0.071 lbs. a.i./A to lettuce 0.198 lbs. a.i./A), and
present a range of application rate to seed size ratios (e.g. lettuce and corn).
For all size classes of mammals, the acute LOC was exceeded (RQs ranged from 0.22 to 174) for
dose-based exposures to any of the assessed seeds other than soybeans. Moreover, for all size
classes of mammals, acute exceedances occur where less than 10% of the animal's diet consists
of treated lettuce or sugar beet seeds (or crops for which lettuce and sugar beets serve as
surrogates). Area-based analysis identified no risks of concern for mammals (RQs <0.01 to
0.31).
The chronic LOC was exceeded for all size classes of mammals consuming any of the assessed
treated seed (RQs ranged from 4.57 to 3655). The highest chronic RQ exceedances for treated
seed was for lettuce.
Thiamethoxam:
Foliar and Soil Applications: There were no acute or chronic risks of concern identified for
mammals from any foliar or soil applications. Estimates presented in the agency's Preliminary
Risk Assessment to Support the Registration Review of Thiamethoxam were based on an upper-
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bound application rate for both foliar agricultural (0.086 lbs. a.i./A) and soil agricultural/non-
agricultural uses (0.265 lbs. a.i./A). Modeling accounted for up to three applications of
thiamethoxam are made per growing season.
Treated Seed Applications: There were potential acute risks of concern identified for mammals
from certain thiamethoxam seed treatment uses. Sugar beets were the only crop assessed where
there was an acute LOC exceedance for thiamethoxam-treated seeds. These exceedances were
identified for all size classes of mammals (RQs = 0.99 - 2.16).
There were chronic risk exceedances for corn, cotton, and sugar beet (RQs = 2.73 - 55.33).
There were no chronic LOC exceedances for soybean. Chronic LOC exceedances were an order
of magnitude greater for sugar beet (RQs = 25.33 - 55.33) than for corn (2.79 - 6.08) or cotton
(2.73 - 5.97). For both acute and chronic risks, RQs increased as mammal size decreased.
Mammals - Risk Characterization
Clothianidin and Thiamethoxam
There are several variables impacting potential risks to mammals from seed treatments, such as
how far apart and how many seeds are available at a given time, the amount of cover provided by
field conditions (newly planted fields are likely to be open and provide less cover than no till
fields, making them less attractive as a forage location for smaller mammals), and whether or not
seeds are on the surface of a field vs. incorporated into the soil. Seeds buried below the soil
surface are not as easily found by foraging mammals, reducing the potential for exposure and
increasing the amount of time required to find them, which in turn decreases the likelihood of
potential chronic exposure. However, some mammals are highly capable of burrowing in soil
and acquiring buried seeds and may cache them for later consumption. In addition, in the case of
chronic risks, the impact of consuming treated seeds may vary by life stage. It is currently an
uncertainty whether effects seen in laboratory-based reproduction studies occur at a sensitive life
stage or are due to the entire exposure period.
Another source of uncertainty are the scaling factors used to predict toxicity in different size
mammals. This is important because the number of seeds a mammal needs to consume before
toxicological effects are expected vary by the size of the mammal, with larger mammals
expected to be more sensitive based on standard scaling factors.
• For clothianidin:
o the number of treated seeds required to reach the lowest observed adverse effect
concentration (LOAEC; e.g. decreased body weight, stillbirths, delayed sexual
maturation) for chronic effects would be 1 - 6 corn seeds, 1-10 lettuce seeds, 1 -
12 sugar beet seeds, 1-21 cotton seeds, and 2-58 soybean seeds, depending on
mammal size; and
o chronic exceedances occur when less than 10% of the animal's (all size classes of
mammals) diet consists of clothianidin treated seeds (all evaluated treated seeds
except soybean).
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• For thiamethoxam:
o there were reduced offspring body weight gains reported during the lactation
period (NOAEL = 61 mg/kg-bw/day; LOAEL =158 mg/kg-bw/day) in the
chronic mammalian reproductive study;
o based on the NOAEL, the number of seeds required to reach this chronic effect
for corn, cotton, and sugar beet ranges from 2-37, 5 - 123, and 3 - 64,
respectively; and
o based on the LOAEL, the required number of seeds for these crops are 4-96, 14
- 320, and 7-166, respectively.
Although there are potential acute risks of concern for clothianidin (all seeds evaluated except
soybean) and thiamethoxam (sugar beet) treated seeds, the uncertainties discussed above limit
the likelihood that an animal will consume acutely toxic levels of treated seeds. Overall, for
clothianidin and thiamethoxam, potential risk is associated with chronic consumption of treated
seeds, where the estimated number of seeds required for chronic effects is low.
Birds, Reptiles, and Terrestrial-Phase Amphibians - Risk Estimates
Clothianidin is characterized as moderately toxic to birds on an acute oral exposure basis and
practically nontoxic on a subacute dietary exposure basis. Northern bobwhite quail (Colinus
virginianus) represented the most sensitive chronic toxicity endpoint (NOAEC: 205 mg/kg-diet;
LOAEC: 525 mg/kg-diet), with effects on reduced eggshell thickness. Thiamethoxam is
characterized as slightly toxic to birds on an acute oral exposure basis (LCso = 576 mg/kg-
bw/day) and practically non-toxic on a subacute dietary exposure basis (LCso > 5200 mg/kg-
diet). Weight loss was seen in a chronic avian reproductive study in parental males at 900 mg/kg-
diet (NOAEC 300 mg/kg-diet). The most sensitive avian species assessed for thiamethoxam is
the mallard duck for both acute and chronic exposures. Note that birds are used as surrogates for
potential risks to terrestrial-phase amphibians and reptiles.
Clothianidin:
Foliar Applications: For foliar applications of clothianidin, there are no acute or chronic risks of
concern for birds even when calculated using the maximum registered foliar single application
rate of 0.4 lbs. a.i./A (RQs <0.01 - 0.33; LOCs = 0.5 for acute risks and 1.0 for chronic risks).
RQs decreased with avian weight class and are highest (0.33) for small birds feeding on short
grass.
Soil Applications: Area-based analysis identified LOC exceedances for small birds only at the
highest soil application rate of 0.4 lbs. a.i./A (RQ = 0.63). Acute risks of concern are also
identified following field applications of manure from clothianidin-treated poultry houses. This
scenario is assumed to be equivalent to a soil application rate of clothianidin at 0.49 lbs. a.i./A
and resulted in an RQ of 0.77.
Based on an analysis of using the upper bound Kenaga EECs in arthropods following soil
applications as a surrogate for potential exposures of likely dietary items following soil
exposures, there are no acute risks of concern for species of birds (highest RQ = 0.16 for the
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scenario of spent poultry litter use). Similarly, chronic exposures for birds are below any effect
level thresholds (highest chronic RQ = 0.22 for the scenario of spent poultry litter use).
Seed Treatment Formulations: As mentioned previously in the clothianidin mammal section,
RQs are calculated for various crops when assessing potential risks to birds from treated seeds.
Expected risks are highest for small birds and decreases with increasing avian body weight. For
small and medium birds, there are acute dose-based species LOC exceedances for all crops (RQs
range from 1.20 - 284). For large birds, there are acute dose-based species LOC exceedances for
birds feeding on corn, sugar beets and lettuce (or for crops for which corn, sugar beets and
lettuce serve as surrogates). Area-based analysis identified no risks of concern for avian species,
but there is a chronic LOC exceedance for birds consuming any of the assessed treated seeds
(RQs ranged from 5.0 to 1813). Moreover, for all size classes of birds, acute exceedances occur
where less than 10% of the animal's diet consists of treated lettuce or sugar beet seeds.
Thiamethoxam:
Foliar and Soil Applications: There were no acute or chronic RQ exceedances identified for
birds (acute LOC = 0.5; chronic LOC = 1.0) either directly from any foliar or soil applications,
or from birds consuming arthropods with residues resulting from either a foliar or soil treatment.
Therefore, there are no risks of concern for birds from foliar or soil applications.
Seed Treatment Formulations: RQs were calculated for corn, cotton, soy, and sugar beet when
assessing potential risks to birds from thiamethoxam-treated seeds. No RQ exceedances were
identified using an area-based analysis of potential risks, but there were acute dose-based
exceedances for all crops except soybean, and chronic exceedances for all modeled crops and
size classes. Chronic RQ exceedances range from 12.6 - 117. Both acute and chronic
exceedances were highest for sugar beet (highest acute RQ = 29.6; chronic RQ = 117). Risk
estimates were highest for small birds and decrease with increasing avian body weight.
Birds, Reptiles, and Terrestrial-Phase Amphibians - Risk Characterization
In field conditions, the exposure of birds to clothianidin-treated seed is dependent upon many
variables beyond the amount of active ingredient on a given treated seed. These factors include
whether or not the treated seed is buried or on the surface of a field (as in the case of an
accidental seed spill), the depth at which buried seed is buried, the number and density of treated
areas across the landscape, and the seed size relative to the size and foraging patterns of birds.
For birds of any size, the attractiveness of the treated seed as a source of food is relative to the
color or size of other available food sources. The size of a bird is also important in predicting
effects expected from exposure, because larger birds generally need to consume more treated
seeds before toxicological effects are observed. Using the chronic avian reproduction toxicity
endpoint associated with diminished eggshell thickness, the number of treated seeds required to
reach this level would be 1 - 19 corn seeds, 1-32 lettuce seeds, 1-39 sugar beet seeds, 1-69
cotton seeds, and 4-186 soybean seeds.
The size of a treated seed relative to the size of a given bird is another important variable to
consider when characterizing potential risks from clothianidin-treated seed. In the case of small
birds, treated seeds which are large either due to pelleting or the size of an individual seed may
be too big for a small (20g) passerine bird to swallow. Based on minimum weights of field corn
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seed (-225 mg), and cotton seed (-100 mg), these seeds are considered too big for most small
passerine birds to consume. Therefore, acute and dietary risks from consumption of these seeds
can be discounted for these size classes of passerines. Field corn seed is also considered too big
for medium-sized passerine birds to consume. Other types of corn seed (e.g. sweet, pop, etc.)
exhibit a size range such that the average seed size is below the weight threshold for medium-
sized passerines. Consequently, medium-sized passerines could still potentially be affected by
consuming other corn varieties.
The largest birds would physically be able to consume a wider range of treated seeds, due to their
size, but would need to consume a greater number of seeds than their smaller counterparts to
experience negative health effects. For large birds foraging in corn fields, nearly their entire diet
(99%) would have to be made up of the treated seed in order to reach the acute LOC. Given the
potential availability of other seed sources (i.e. remaining waste grain or seeds from weed
species on the field), this may be more likely in instances of treated seed spillage than through
normal foraging behavior.
Terrestrial Invertebrates - Risk Estimates
This section incorporates information provided in the Preliminary Bee Risk Assessment to
Support the Registration Review of Clothianidin and Thiamethoxam as well as the more recent
Final Bee Risk Assessment to Support the Registration Review of Clothianidin and
Thiamethoxam, which are available on the public docket. The initial preliminary bee assessment
in 2017 evaluated the risk of the registered agricultural uses of clothianidin and/or thiamethoxam
to bees alone. The 2017 assessment utilized available data at the time. For clothianidin and
thiamethoxam this included a robust registrant-submitted dataset to help characterize the acute
and chronic toxicity of clothianidin and/or thiamethoxam to adult and larval honeybees at the
Tier I (individual) level. In each assessment, available open literature data was also reviewed in
addition to the required data.
The final 2019 bee risk assessment updates the preliminary bee assessment and incorporates
additional information, submitted to the EPA since the previous assessment. This new
assessment also includes additional residue study data, which provide residues of clothianidin
and/or thiamethoxam in nectar, pollen, and other plant matrices for registered crop uses; as well
as a residue bridging strategy to extrapolate, where appropriate, residue data among crops,
chemicals, and plant matrices to address lack of residue data for certain crops between the
neonicotinoids. This additional information includes higher tiered, Tier II and III (colony) level
data. Tier II data included both semi-field tunnel (rate-response) and feeding (dose-response)
studies to help better evaluate potential colony-level effects, and tier III data included whole
colony full field studies to better evaluate colony-level effects. For clothianidin, there were Tier
III field studies conducted on canola or maize seeds. Thiamethoxam had available Tier III field
studies conducted on sunflower seed-treated fields, oilseed rape seed-treated fields, and a foliar-
treated apple orchard. These Tier III studies were all included in the most recent assessment.
Data was requested based on a tiered approach, as lower tiered data could trigger the need for
higher tiered data.
During the scoping of the registration review for clothianidin and thiamethoxam, the agency
identified the need to assess risk to terrestrial invertebrates. As a result, the agency issued
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requirements for a robust set of pollinator data, which included both exposure and toxicity data,
along with higher tiered pollinator tests such as Tier II (semi-field) and Tier III tests (full field).
During testing, honeybees (Apis mellifera) were used as a surrogate for other species of bees
(e.g. bumble bees, solitary bees). Risks to these other non-Apis bees are evaluated qualitatively
based on available information. As the bee risk assessment framework used by the EPA
indicates, honeybees are considered to be reasonable surrogates for other bee species and
conclusions from the weight of evidence for the honeybee can be used to help inform about
potential risks to other non-Apis species. An exception is noted based on the differences in
attractiveness of crops to different bee species.
Among the four neonicotinoids (imidacloprid, clothianidin, thiamethoxam, dinotefuran), robust
data sets of pollen and nectar residue data available for foliar and/or soil applications to the
following bee-attractive crops and crop groups: cotton, cucurbits, citrus, stone fruit, pome fruit,
tree nuts, berries/small fruits, and ornamentals. Surrogates were used in some areas where
limited or no residue data was available. Generally, this risk assessment finds that foliar and/or
soil applications of clothianidin and thiamethoxam to honeybee attractive crops which are not
harvested prior to bloom result in a potential for colony-level risk. Robust data are also available
for seed treatments of imidacloprid, clothianidin and thiamethoxam to several crops, including
corn. In general, risks of neonicotinoid seed treatments to honeybee colonies are considered low.
As noted previously, clothianidin is a major degradate of thiamethoxam (in plants). As
clothianidin and thiamethoxam have similar use patterns, and their toxic effects and the
concentrations at which these toxic effects occur are similar for bees, the Final Bee Risk
Assessment to Support the Registration Review of Clothianidin and Thiamethoxam expressed
exposure and effects as "clothianidin equivalents" (c.e.), where thiamethoxam concentrations are
converted using the molecular weight ratio of clothianidin to thiamethoxam (i.e., ratio = 0.856)2.
Based on the evaluated data, clothianidin and thiamethoxam are classified as toxic to adult
honeybees with similar acute oral LD50 values (0.0037 jag c.e./bee and 0.0038 jag c.e./bee,
respectively) and acute contact LDso values (0.0275 jag c.e./bee and 0.021 jag c.e./bee,
respectively). There are no acceptable definitive acute oral larval toxicity studies available for
clothianidin and thiamethoxam. Therefore, acute dose-based RQs were not calculated for larvae.
However, there is an acceptable larval chronic toxicity study for thiamethoxam, which was used
to derive an acute oral toxicity estimate (> 0.03 |ig c.e./larvae; 5% mortality). For clothianidin
and thiamethoxam, there are acute contact risks to adult bees exposed to foliar applications (RQ
= 52 and 5.1, respectively; LOC = 0.4). Also, for clothianidin and thiamethoxam, there are acute
dose-based oral exposure risks from foliar use (RQs = 3,600 and 350, respectively); from soil
(RQs ranged 1.2 - 7.0); and from seed treatment use (RQ = 79). The highest acute exceedances
for clothianidin are from foliar uses on berries and small fruit, soil uses for cucurbits, and foliar
uses for oilseed. For thiamethoxam, the highest acute exceedances are from foliar uses on
ornamentals, soil uses for fruiting vegetables, and foliar uses for berries and small fruit.
For clothianidin and thiamethoxam, there were chronic oral toxicity exceedances (LOC = 1) for
foliar and soil applications. Adult bee chronic RQs ranged from 3,600 - 36,000 for foliar
applications, and 13-70 for soil applications. There were also chronic oral toxicity exceedances
identified for larval bees (RQs ranged 300 to 1,500) from foliar uses of clothianidin and
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thiamethoxam. For soil uses of clothianidin (non-agricultural), there were chronic exceedances to
bee larvae (RQs ranged 2.1 to 2.3). There were also chronic oral exceedances for seed treatment
uses for both adult and larval bees (RQ = 810 and 29, respectively). The highest chronic
exceedances for clothianidin were from soil use for citrus and cucurbits, and foliar use on
oilseed. For thiamethoxam, the highest chronic exceedances occurred from foliar use on
ornamentals, berries and small fruit, and cucurbits.
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: assumptions on available attractive forage off field, use
of individual level toxicity data, BeeREX default estimates for residues, and unrefined
AgDRIFT™ modeling. Soil applications are assumed to have a low off-field risk because of low
potential to drift. Off-field estimates of risk are based on screening-level exposure estimates,
which cannot be refined with available residue data. Moreover, these estimates relied on
assumptions regarding crop-attractiveness to bees, exposures, cultural practices {i.e. harvest
cycles), environmental conditions {i.e. canopy coverage), wind conditions (i.e. unidirectional and
constant), etc. Therefore, potential off-field risks may be overestimated. Additionally, exposure
to individual bees from off-site movement of abraded seed dust during planting is noted as a
potential exposure route of concern.
Due to neonicotinoid persistence in the environment, poultry litter usage estimates indicated
potential risk to bees when applied at the maximum allowed rate (0.49 lbs. a.i./A; clothianidin
only) when applied on multiple occasions (six whole house treatments) and then utilized as
fertilizer on agricultural fields. Based on that maximum rate, RQs calculated using the Bee-REX
model showed acute and chronic exceedances to adult bees (RQs 7 and 70, respectively) and
chronic risk to larval bees (RQ of 2.3).
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 clothianidin and
thiamethoxam residues measured in pollen and nectar in various crops to levels that affect honey
bee colonies. At the Tier III level, this involved analysis of full field studies that were conducted
for clothianidin and thiamethoxam seed treatments (various crops). In addition, this involved
analysis of full field studies that were conducted on thiamethoxam foliar applications to orchards
or melons. These Tier III studies contained significant uncertainties associated with the study
design and availability of data which limited their utility. These uncertainties include the origin
of the pollen and nectar brought back to the hives, high variability in the data collected
(including in control hives), and inadequate replication or pseudo-replication (e.g. studies
conducted using only one field). Ecological incidents were also considered as a line of evidence.
For a detailed explanation of these risk estimates, please refer to the Final Bee Risk Assessment
to Support the Registration Review of Clothianidin and Thiamethoxam, available in the dockets.
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
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relative to bloom) to determine if exposure was present, a comparison of residues to adverse
effects levels for entire hives (residues above NOAEC and LOAEC), and major categories of
incidents. For comparison of residues to adverse effects levels for entire hives, EPA considered
duration and frequency of exceedance, the magnitude of exceedance (including the ration of max
residue value to NOAEC/LOAEC and percent of diet from the treated field needed to reach the
NOAEC/LOAEC), as well as consideration of usage and geographic scale/spatial distribution of
exposure.
It is important to note that multiple factors can influence the strength and survival of bees
whether they are solitary or social. These factors, including disease, pests (e.g., mites), nutrition,
and bee management practices, can confound the interpretation of studies intended to examine
the relationship of the test chemical to a receptor (i.e., larval or adult bee). Therefore, most
studies attempt to minimize the extent to which these other factors impact the study; however,
higher-tier studies afford less control over these other factors, and their role may become
increasingly prominent as the duration of the study is extended. Although studies attempt to
minimize the confounding effects of other environmental factors, there is uncertainty regarding
the extent to which the effects of a chemical may be substantially different had these other
factors been in place.
Strongest Evidence of On-field Risk: For foliar and soil applications of clothianidin and
thiamethoxam, the lines of evidence are considered "strongest" for supporting the finding of
colony-level risk resulting from applications to:
• For Clothianidin:
o Cotton (foliar);
o Cucurbits (foliar);
o Grapes (foliar, pre-bloom); and
o Ornamentals (foliar and soil).
• For Thiamethoxam:
o Cotton (foliar);
o Cucurbits (foliar);
o Orchard crops (i.e., citrus, pome, stone and tropical fruits, tree nuts; foliar, pre-
bloom);
o Citrus (soil, pre-bloom);
o Berries (foliar and soil, pre-bloom;
o Honeybee attractive fruiting vegetables (i.e., okra, roselle, chilis and peppers;
foliar); and
o Ornamentals (foliar and soil).
These findings are supported by multiple lines evidence indicating residues exceed the
clothianidin and/or thiamethoxam colony-level endpoints by a high magnitude, frequency and/or
duration. In some cases, they are also supported by modeled residues or ecological incidents
involving bees that are associated with the use.
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Moderate Evidence of On-field Risk: For foliar and soil application of clothianidin and
thiamethoxam, the strength of evidence is considered "moderate" in indicating a colony-level
risk to honeybees for the following registered uses:
• Clothianidin and Thiamethoxam:
o Citrus (soil, post-bloom);
o Cucurbits (soil);
o Residential lawns (foliar); and
o Ornamentals (foliar and soil).
• Thiamethoxam only:
o Honeybee attractive fruiting vegetables (soil).
These findings are supported by lines of evidence indicating residues exceed the clothianidin
and/or thiamethoxam colony-level endpoints but the magnitude, frequency and/or duration of
exceedance is limited.
Weakest Evidence of On-field Risk: For foliar, soil and seed treatment applications of
clothianidin and thiamethoxam, the strength of evidence is considered "weakest" in indicating a
colony-level risk to honeybees for the following registered uses:
• Clothianidin
o Honeybee attractive root and tuber crops {i.e., sweet potato, Jerusalem artichoke,
edible burdock, dasheen, horseradish; foliar and soil); and
o Turmeric (seed treatment).
• Thiamethoxam
o Honeybee attractive root and tuber crops (foliar and soil);
o Citrus (soil, post-bloom); and
o Mint (foliar).
For thiamethoxam applications (foliar) to mint, the evidence is considered weakest because risk
findings rely exclusively on residue data that are extrapolated (bridged) from other
neonicotinoids or different crop groups where the influence of crop on the magnitude of the
residue is highly uncertain. The clothianidin use for treated turmeric seed pieces, the evidence is
considered weakest because risk findings rely on nectar and pollen exposures extrapolated from
the size of treated seeds, but turmeric is planted as large seed pieces.
For clothianidin and thiamethoxam applications to honeybee attractive root and tuber crops, the
evidence is considered weakest because of the following. Clothianidin residue data are available
for potato pollen; however, this crop does not produce nectar like other crops in this group {e.g.,
sweet potatoes). Residues in potato {Solanum tuberosum) pollen are below the colony level
endpoints, however, the agency cannot conclude that nectar-producing honeybee attractive root
and tuber crops pose a low risk because there are no residue data for nectars in this crop group.
When considering residue data for other field crops (e.g., cotton, cucurbits), foliar and soil
applications result in residues in nectar that are above the colony level endpoints. This suggests a
potential concern for nectar-producing root and tuber crops. Available information suggests that
several of these honeybee attractive root and tuber crops are cultivated primarily through their
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roots and not through setting seed, however without further information on the timing of
cultivation relative to bloom periods, honeybee exposure cannot be precluded.
Terrestrial Plants
No risks of concern to terrestrial plants are identified for either clothianidin or thiamethoxam.
For further detail, please refer to Clothianidin - Transmittal of the Preliminary Aquatic and Non-
Pollinator Terrestrial Risk Assessment to Support Registration Review and Thiamethoxam -
Transmittal of the Preliminary Aquatic and Non-Pollinator Terrestrial Risk Assessment to
Support Registration Review, both available in their respective dockets.
Aquatic Risks
Although clothianidin and thiamethoxam were assessed together in one bee risk assessment,
separate aquatic assessments were conducted. In terrestrial plants, clothianidin is observed as a
major degradate of thiamethoxam. In other environmental fate studies (e.g., hydrolysis, aerobic
soil metabolism), clothianidin is a minor degradate. Therefore, in the aquatic risk assessment of
thiamethoxam, only the parent compound is considered as a residue of concern. This section
describes the risks to aquatic organisms from clothianidin and thiamethoxam applications.
Freshwater Fish. Estuarine/Marine Fish, and Aquatic-Phase Amphibians
On an acute basis, clothianidin is characterized as practically non-toxic to freshwater fish and no
more than slightly toxic for estuarine/marine fish. Thiamethoxam is also characterized as
practically non-toxic to fish on an acute exposure basis. Clothianidin and thiamethoxam both had
minor effects on fish growth after chronic exposure. There are no risks of concern to fish or
aquatic-phase amphibians from either clothianidin or thiamethoxam. The acute and chronic RQs
for fish (which were used as surrogates for aquatic-phase amphibians when calculating RQs) did
not exceed the acute (0.5) or chronic (1.0) LOC for any uses (clothianidin RQs < 0.001;
thiamethoxam RQs < 0.002). Potential risks to fish and aquatic-phase amphibians are therefore
considered low for these chemicals.
Freshwater Invertebrates
For aquatic invertebrates, the level of sensitivity varies greatly among species on an acute
toxicity basis. For example, clothianidin is practically non-toxic to water fleas (Daphnia magna),
but is very highly toxic to other taxa, including shrimp and aquatic insects. Reproduction is
affected in both freshwater and estuarine/marine invertebrates. Effects on development were also
observed in benthic invertebrates.
On an acute exposure basis, thiamethoxam is very highly toxic {i.e., LCso < 100 jag a.i./L) to
aquatic invertebrates. Tested insect species are more sensitive on an acute exposure basis
compared to tested species in other classes {e.g., daphnids and mysid shrimp). On a chronic
exposure basis, a decrease in survival is observed in aquatic insects exposed to 2.23 jag a.i./L,
resulting in aNOAEC of 0.74. As with acute exposure, daphnids and mysid shrimp are orders of
magnitude less sensitive when exposed to thiamethoxam on a chronic exposure basis.
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
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publication of the Clothianidin - Transmittal of the Preliminary Aquatic and Non-Pollinator
Terrestrial Risk Assessment to Support Registration Review (2017) and the Thiamethoxam -
Transmittal of the Preliminary Aquatic and Non-Pollinator Terrestrial Risk Assessment to
Support Registration Review (2017).The studies, located in the docket, were used to determine
risks quotients using acute and chronic toxicity data provided in the two open literature papers
published by researchers from the University of Guelph.10'11 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 (clothianidin, thiamethoxam, dinotefuran, 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. On average, LCso values for clothianidin were 2.4 times higher than
those of imidacloprid and dinotefuran, suggesting that clothianidin may be relatively less acutely
toxic than imidacloprid and dinotefuran. Thiamethoxam's LCso values were 5.6 times higher
than those of imidacloprid across all tested species, which suggests that thiamethoxam is
potentially the least acutely toxic.
All four neonicotinoids present chronic risks of concern to freshwater invertebrates, where
clothianidin and imidacloprid have similar toxicities. Based on midge data (generally more
sensitive than mayflies), dinotefuran and thiamethoxam are relatively less sensitive (decreased
factors of-2.3 and 5.3, respectively) than imidacloprid and clothianidin. There is a ~4X factor
difference in sensitivity across the four neonicotinoids where dinotefuran is the least sensitive.
Dinotefuran and thiamethoxam are also reported as the least sensitive in mayfly data as well.
Two notable uncertainties within the Raby et. al. data include: 1) inconsistent analytical
verification of concentrations, and 2) different control performance in the imidacloprid testing.
For 1), not all test concentrations were confirmed through analytical verification. As a result, the
LCso and NOAEC values are based on nominal concentrations. From the limited subset of test
concentrations that were analyzed, the measured values were similar to the nominal
concentrations, and are 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
10 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.
11 Raby, M; Zhao, X.; Hao, C.; Poirier, D.G. and P.K. Sibley. 2018b. Chronic toxicity of 6 neonicotinoid
insecticides to Chironomus dilutus and Neocloeon triangulifer. Environmental Toxicology and Chemistry, 37 (10):
2727-2739. MRID 50776201.
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imidacloprid controls did meet EPA test method standards and was generally one of the most
sensitive endpoints across chemicals.
Both mayfly and midge studies tested all four neonicotinoids, however when considering
exposure, dinotefuran tended to have the highest estimated exposure concentrations (EECs)
among the four chemicals. The other three neonicotinoids were estimated to have similar EECs
to each other. On an acute basis, for the mayfly and midge acute RQs, the majority of
clothianidin and dinotefuran RQs were greater than those of imidacloprid. Thiamethoxam
appears to present a lower acute risk concern when considering the midge RQs. On a chronic
basis more generally, clothianidin, dinotefuran, and imidacloprid, have similar chronic RQs with
a few exceptions: tree fruit RQs for imidacloprid were eleven times higher than the other A.I.s;
foliar nursery and soil forestry applications RQs for clothianidin were an order of magnitude
higher than imidacloprid; foliar and soil applications as well as seed treatment RQs for
imidacloprid were 13-220 times higher than thiamethoxam. Overall thiamethoxam was found to
have lower exceedances to aquatic invertebrates than the other three nitroguanidine
neonicotinoids.
Estuarine/Marine Invertebrates
For clothianidin foliar applications, there are no acute risks identified for all uses (RQs < 0.5)
except for use on rice (RQs = 1.6; foliar and seed treatment). The chronic LOC (1) is only
exceeded for foliar uses on fruit and nut trees, ornamentals/shade trees, and rice (RQs ranged
from 1.1 - 5.2). The chronic LOC (1) for soil applications is exceeded for tree fruits and nuts,
cucurbits, fruiting and leafy vegetables, and low growing berries (RQs ranged 1.6 - 1.9). For
clothianidin seed treatments, there are no acute LOC (0.5) exceedances, except for the use on
rice (RQ < 1.4). There are also no chronic LOC (1) exceedances except for use on rice (RQ =
1.7). For the poultry house use of clothianidin (0.49 lbs. a.i./A), the acute LOC is not exceeded
(RQs < 0.31), however, the chronic LOC is exceeded (RQ < 3.0).
None of the saltwater (SW) invertebrate acute or chronic RQs exceeded the LOCs for
thiamethoxam uses with foliar, soil and seed treatments.
Aquatic Vascular and Non-Vascular Plants
There are no risks of concern to aquatic plants from either clothianidin or thiamethoxam.
The RQs for aquatic vascular and non-vascular plants did not exceed the LOC (1) for any uses
(clothianidin RQs < 0.16; thiamethoxam (RQs <0.001). For clothianidin, effects on yield were
observed in both aquatic vascular and non-vascular plants but only at high test concentrations
(0.075 lbs. a.i./A; single application).
2. Ecological Incidents
i. Pollinator Incidents
The Office of Pesticide Programs (OPP) maintains a database called the Incident Database
System (IDS) in which wildlife incidents reported to the agency from a variety of sources are
maintained. The sources of information for incidents include registrant reports (aggregated
incidents) submitted under the FIFRA §6(a)(2) reporting requirement, as well as reports from
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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. A search of IDS for aggregated incidents was
conducted on May 2, 2019 for clothianidin and thiamethoxam. Incidents in IDS are classified as
"not determined," "unlikely," "possible," "probable," and "highly probable".
There were 54 ecological incidents affecting bees in the United States associated with the use of
clothianidin that were reported in the IDS between 2010 and 2018. Some incidents involved
clothianidin and other chemicals. The majority of reported incidents involved commercial
honeybees. The incident reports' classifications ranged from unlikely to highly probable, where
15 incidents were classified as "highly probable," and 16 incidents were classified as "probable".
Considering all reported incidents, 19 of the incidents were attributed to registered uses of
clothianidin (i.e., corn, cotton, canola, and sugar beet) at the time of the incident, but the legality
of use was not determined in 34 of the reported incidents, and a single incident was considered a
misuse. There were 27 incidents where entire honeybee colonies were affected that were
associated with corn, however, there was insufficient evidence to correlate clothianidin or the
other neonicotinoids to these incidents. All but four of these 27 incidents occurred prior to 2015.
From 2002 - 2018, there were 22 incidents reported in the US for honeybees in association with
agricultural uses of thiamethoxam. Seven of the incidents with certainties of highly probable or
possible have been reported in association with corn planting in Indiana, Minnesota, and Illinois.
Observations included hundreds to thousands of dead bees and bees with behavioral impacts.
Twelve incidents considered probable or possible were reported by the state of Washington in
2002 in association with applications of thiamethoxam to orchards (as unspecified, or to pears or
cherries). In most of these incidents, the bee hives were located within the treated orchards. In
addition, an incident was reported in California in association with thiamethoxam applications to
lemon trees. In 2018, an incident was reported in association with an application to watermelons.
One additional incident was associated with applications to an "agricultural area".
ii. Aquatic and Non-Pollinator Terrestrial Incidents
A review of the IDS database for incidents involving wildlife including aquatic organisms as
well as plants was completed on June 15, 2017. There was one incident submitted for
clothianidin for the Poncho Beta formulation, which reported crop damage in Idaho in August
2014 from spray drift. However, that incident was also associated with several other insecticides,
fungicides, and herbicides. There were four incidents submitted for thiamethoxam. Three of the
four incidents involved plant crops (i.e. beans, corn, etc.), and one incident involved birds. All
four incidents listed thiamethoxam as a "possible" cause for the reported incident, however,
these incidents were also associated with other chemicals.
In addition to the incidents described above, additional incidents are reported to the agency in
aggregated incident reports. Pesticide registrants report certain types of incidents to the agency as
aggregate counts of incidents occurring per product per quarter. Ecological incidents reported in
aggregate reports include those categorized as 'minor fish and wildlife' (W - B), 'minor plant' (P
- B), and 'other non-target' (ONT) incidents. 'Other non-target' incidents include reports of
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adverse effects to insects and other terrestrial invertebrates. No aggregate incident reports for W
- B or P - B have been submitted to the agency for clothianidin or thiamethoxam.
Although there were limited or no incident reports received by the agency for clothianidin or
thiamethoxam related to terrestrial wildlife and/or plants, the absence of reported incidents
should not be construed as the absence of incidents. Incident reports for non-target organisms
typically provide information only on mortality events and plant damage incidents. Except for
phytotoxic effects in terrestrial plants, sublethal effects, such as reduced growth or impaired
reproduction, are rarely reported. EPA's changes in the registrant reporting requirements for
incidents in 1998 may account for a reduced number of reported incidents. Registrants are now
only required to submit detailed information on 'major' fish, wildlife, and plant incidents. Minor
fish, wildlife, and plant incidents, as well as all other nontarget incidents, are generally reported
aggregately and are not included in the Ecological Incident Information System (EIIS). In
addition, there have been changes in state monitoring efforts due to lack of resources.
The agency will continue to monitor ecological incident information as it is reported to the
agency. Detailed analyses of these incidents are conducted if reported information indicates
concerns for risk to non-target organisms.
3. Ecological and Environmental Fate Data Needs
The ecological and environmental fate database for clothianidin and thiamethoxam is complete.
No additional fate data is needed for the clothianidin and thiamethoxam registration review.
C. Benefits Assessment
This section of the PID is organized to begin with a brief benefits overview for clothianidin and
thiamethoxam, followed by a more detailed summary of their usage in several crop groups (e.g.
berries, citrus, cucurbits, pome fruit, stone fruit, etc.). Crop groups described below were the
subjects of in-depth benefits assessment memoranda that are part of the documents being
released in the neonicotinoid dockets at www.reeulatioms.gov for public comment.
The EPA conducted a number of use site-specific benefits assessments for the neonicotinoids as
a pesticide class. Each assessment considered the advantages of the individual neonicotinoid
active ingredients, including their use in targeting particular pests, average application rates,
acres treated and potential alternatives, which are described in detail in the benefits assessments
available in the docket (see Section I. 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 different pests depending on the use setting;
• Offer both immediate, contact control and systemic, residual control of pests over an
extended period of time; and
• Are comparatively less expensive and more effective than some alternatives.
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Clothianidin is a nitroguanidine-substituted neonicotinoid insecticide used to control damaging
pests of concern across a wide range of agricultural and non-agricultural use sites.
Neonicotinoids act on the central nervous system of insects, causing irreversible blockage of the
postsynaptic nicotinergic acetylcholine receptors (via a selective agonistic mechanism). The
primary pests targeted for control with clothianidin include piercing and sucking pests such as
aphids, mealybugs, sharpshooters, Asian citrus and pear psyllids and stinkbugs; coleopteran pests
such as corn rootworm, billbugs, white grubs, and plum curculio; and a variety of sporadic pests
such seed maggots and symphylans. Clothianidin is registered for use on root and tuber
vegetables, bulb vegetables, leafy vegetables (brassica and non-brassica), legumes, fruiting
vegetables, cucurbits, citrus fruit, pome fruit, stone fruit, berries and small fruit, tree nuts, cereal
grains, oilseed crops, and other unclassified crops.
Thiamethoxam is a second-generation neonicotinoid insecticide, belonging to the thianicotinyl
subclass. Thiamethoxam acts on the central nervous system of insects by binding to the
postsynaptic nicotinic acetylcholine receptor and has systemic and contact activity. The primary
pests targeted for control with thiamethoxam include piercing sucking pests such as aphids,
leafhoppers, and whitefly in addition to certain hard to kill pests such as pepper weevil and
thrips. Thiamethoxam is also highly water soluble and is readily translocated in plant tissue
giving it good systemic activity. Registered uses for thiamethoxam encompass a wide range of
agricultural use sites, which includes root and tuber vegetables, leafy vegetables (brassica and
non-brassica), legumes, fruiting vegetables, cucurbits, citrus fruit, pome fruit, stone fruit, berries
and small fruit, cereal grains, etc. There are also a number of non-agricultural use sites (e.g.
warehouses, schools, residential living spaces, etc.).
The following are summaries of the benefits assessments available in the public docket. 12'13
Berries
Berries refer to strawberry, caneberry (blackberry, raspberry, etc.), cranberry, and blueberry, as
well as multiple other small soft fruit grown on very small acreage. Neonicotinoids, including
clothianidin and thiamethoxam, provide both contact and systemic control of numerous
economically significant pests in berry crops.
Clothianidin is registered for use on cranberry and blueberry. Clothianidin is recommended for
control of cranberry girdler and weevils in cranberry production. Weevil damage can result in
plant damage and cranberry feeding damage can result in plant death. Alternatives for the control
of weevils include chlorpyrifos and indoxacarb as well as other neonicotinoids (such as
imidacloprid, dinotefuran, and acetamiprid). Clothianidin is the only insecticide recommended
for control of cranberry girdler.
Thiamethoxam is registered for soil and foliar applications on several berry crops including
blueberry, caneberry (including raspberry and blackberry), strawberry and cranberry. Strawberry
and caneberry growers rely heavily on thiamethoxam, treating around a third of the acres grown.
It is less used in blueberry, where use of imidacloprid is more common. There are no usage data
12 fattps ://www. regulations. gov/docket?D=EP A-HQ-QPP-20.1. .1. -0865
13 https://www.regutations.gov/doeket?D=EPA~HQ~OPP~ |1
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available for cranberry production. Thiamethoxam is used for the control of aphids and
whiteflies, but primarily for Lygus bug in strawberry; aphids, potato leafhopper, root weevils,
and spotted wing drosophila in caneberry; cranberry flea beetle, leafhopper, and weevil in
cranberry; and aphids, sharpnosed leafhopper, and Japanese beetle in blueberry production.
These pests cause direct feeding damage (i.e. Japanese beetle and cranberry flea beetle) and
transmit diseases (i.e. aphids and leafhoppers). Alternatives vary greatly by crop and target pest,
but generally include: organophosphates, pyrethroids and other neonicotinoids (such as
imidacloprid and acetamiprid)
For more information, refer to Benefits ofNeonicotinoidInsecticide Use in Berries (Strawberry,
Caneberry, Cranberry, and Blueberry) and Impacts of Potential Mitigation available in the docket.
Citrus
On average from 2011 to 2015, there were 3,100 total citrus acres treated annually with
clothianidin and 284,000 total citrus acres treated annually with thiamethoxam.14 Data from 2014
to 2018 indicate substantial increases in usage, by 67% and 40% respectively.15 In general, the
Asian Citrus Psyllid (ACP) is the primary pest targeted by the neonicotinoids; thiamethoxam
also targets rust mites and the Fuller rose beetle. ACP is an invasive species that transmits the
pervasive bacterial disease Huanglongbing (HLB), also known as the citrus greening disease.
Infected trees experience premature fruit drop, and the fruit available at harvest are smaller and
have a bitter, metallic taste that impacts the quality of fruit produced. More than 90% of all
Florida citrus acres are now affected by HLB. There is no cure for HLB and all infected trees
eventually die; infected trees must be removed from commercial orchards to avoid contributing
to the spread of the disease. Without thiamethoxam, growers would increase use of insecticides
such as organophosphates (e.g., acephate, malathion) and pyrethroids (e.g., bifenthrin, lambda-
cyhalothrin, cyfluthrin), as well as acetamiprid, a chloropyridinyl neonicotinoid. Control costs
would increase, and control would likely be compromised as well, leading to an increased
number of trees infected with HLB, which would have to be removed and replaced at substantial
cost.
Thiamethoxam also targets citrus leafminer and mites, and, in California, the Fuller rose beetle.
Alternatives for leafminer and mite include abamectin and spirotetramat. There do not appear to
be good alternatives to thiamethoxam for the Fuller rose beetle.
For more information, see Benefits of Neonicotinoid Insecticide Use in the Pre-Bloom and Bloom
Periods of Citrus.
Cotton
An average of 6.4 million acres of cotton are treated with a neonicotinoid insecticide. EPA
estimates that almost 69% of acres receive at least one application of a neonicotinoid, primarily
with imidacloprid and thiamethoxam. Accounting for multiple treatments per acre, nearly 9
million acres of cotton are treated with neonicotinoids annually. Seed treatments account for
about 6 million acres, approximately 100,000 acres are treated at-plant, and over 2.8 million
14 Market research data. 2011-2015.
15 Market research data. 2014-2018.
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acres are treated after crop emergence. Thiamethoxam accounts for more than 1.5 million acres
of the area treated after crop emergence, clothianidin is used on just over 100,000 acres and the
rest, about 1.2 million acres, is treated with imidacloprid.
Foliar usage of clothianidin and thiamethoxam in cotton most commonly targets plant and stink
bugs. There are regional differences in usage and target pests. Clothianidin is rarely used in the
Mid-South and Plains states. In the Plains states, the primary target pest of thiamethoxam is the
flea hopper and there is some usage against aphids. These pests cause a variety of damage by
piercing the boll to feed on developing seeds resulting in yield loss and loss of fiber quality.
Without clothianidin, thiamethoxam, or other nitroguanidine neonicotinoids, growers would
probably use a combination of an organophosphate with a pyrethroid, such as acephate or
dicrotophos with lambda-cyhalothrin or bifenthrin, to control plant and stink bugs, which would
increase costs - and lower income - by $3 to $7/acre, depending on the region, which could be
as much as three percent of a grower's net operating revenue.
For more information, see Benefits of Neonicotinoid Insecticide Use in the Pre-Bloom and Bloom
Periods of Cotton.
Cucurbits
Clothianidin has very limited use for foliar and soil applications on cucurbits, with 5,700 total
acres treated annually, on average from 2011 - 2015. Thiamethoxam is primarily used as a soil
or foliar application for cucumbers (12,000 total acres treated annually), but is also applied by
other growers of other cucurbits (e.g. cantaloupes, squash, watermelon, pumpkins) via the same
application methods. Nationally-targeted pests for cucurbits include the whitefly, aphid, thrips
and cucumber beetle. There are several species of whiteflies and aphids that can vary by region,
but these pests all threaten cucurbit crops by direct-feeding and by vectoring viruses or disorders.
There are also several species of thrips that vary by region, and, these pests are known to cause
leaf silvering, leaf curling, flower deformations, and fruit damage. Cucumber beetles occur
nationally but are particularly a pest of concern in the northeast United States. Cucumber beetle
larvae feed on the roots of cucurbit plants, while adults feed on leaves. The alternatives to
neonicotinoids currently in use are bifenthrin, chlorpyrifos, permethrin, carbaryl and zeta-
cypermethrin.
For more information, see Benefits of Neonicotinoid Insecticide Use in Cucurbit Production and
Impacts of Potential Risk Mitigation.
Fruiting Vegetables, Brassica Vegetables, Leafy Green Vegetables, Tree Nuts, Root & Tuber
Vegetables, Bulb Vegetables, and Tropical and Subtropical Fruit
These crop groups account for approximately 35% of neonicotinoids used in agriculture and
about 25% of the acreage treated with neonicotinoids, not including seed treatments. Growers of
fruiting vegetables and Brassica vegetables rely relatively heavily on clothianidin and
thiamethoxam with about 10 to 15 percent of the crop treated, on average.6 Only about five
percent of the leafy greens, tree nuts, and carrots are treated with clothianidin and thiamethoxam;
imidacloprid generally is the dominant neonicotinoid for these crops, as well as for pest control
in tropical/sub tropical fruit. There is little usage of clothianidin and thiamethoxam, or of other
neonicotinoids, in bulb vegetables.
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In general, neonicotinoids, including clothianidin and thiamethoxam, are used in both soil and
foliar applications to manage piercing and sucking pests that feed off the sap of plants, these
pests may also vector diseases. While imidacloprid is often used against aphids and whiteflies,
clothianidin and thiamethoxam often target bagrada bug, stink bugs, leafhoppers, and thrips, as
well as a number of soil-dwelling pests such as springtail and root maggots. Alternatives for
these pests tend to be contact insecticides like OPs and pyrethroids, but which do not provide the
residual systemic control of the neonicotinoids and may have to be applied multiple times
throughout the season. Extension guides discourage use of broad-spectrum insecticides like
pyrethroids early in the season because it may reduce populations of predatory and parasitic
insects and result in secondary pest outbreaks later.
For more information, see Benefits of Neonicotinoid Use and Impacts of Potential Mitigation in
Vegetables, Legumes, Tree Nuts, Herbs, Tropical and Subtropical Fruit Crops.
Grapes
Thiamethoxam has very limited use on grapes with an average of one percent of grape acreage
treated or lower. Thiamethoxam is primarily used for the control of leafhoppers (which includes
glassy-winged sharpshooter). Additionally, thiamethoxam is recommended for the control of
grape pylloxera. These pests cause quality and yield impacts due to direct feeding damage and
disease spread. Alternatives vary by target pest but consist generally of pyrethroids and
organophosphate as well as other neonicotinoids (such as imidacloprid and acetamiprid).
Clothianidin accounts for 29,000 total acres treated (or 25PCT) in table grapes, 8,800 total acres
treated (or 1PCT) in wine grapes, and 2,800 total acres treated (or 1PCT) in raisin grapes.
Clothianidin is used almost exclusively for the control of mealybugs but is also recommended for
the control of leafhoppers (which includes glassy-winged sharpshooters). These pests can cause
quality and yield loss from direct feeding damage and disease transmission. Mealybugs
contaminate fruit with egg clusters and honey dew produced by adults can render the fruit
unmarketable. Grape mealybugs are also the primary vectors of the grapevine leafroll associated
virus (GLRaV), which can spread across vineyards resulting in a 40% loss of crop yields.
Alternative control options include spirotetramat and lime sulfur.
For more information, refer to Benefits of Neonicotinoid Insecticides Usage in Grapes and
Impacts of Potential Mitigation available in the docket.
Pome Fruit
Clothianidin and thiamethoxam are registered for use in pome fruit crops (which includes apple
and pear). Clothianidin accounts for 1,000 of the total acres treated (or 1PCT) in pear production;
20,300 of the total acres treated (or 13PCT) in eastern apple production; and there is no reported
usage in western apple production. Clothianidin is used the control of pear psylla and mealybug
in pear production and for the control of plum curculio and brown marmorated stinkbugs
(BMSB) in apple production. These pests cause quality and yield impacts associated with direct
feeding and mold growth due to honeydew secretion. Alternatives generally include pyrethroids,
organophosphates, and other neonicotinoids (such as imidacloprid and acetamiprid).
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Thiamethoxam accounts for 8,900 of the total acres treated (or 15PCT) in pear production;
80,800 of the total acres treated (or 50PCT) in eastern apple production; and 4,400 of the total
acres treated (or 1PCT) in western apple production. Thiamethoxam is used for the control of
pear psylla and mealybugs in pear production and plum curculio, aphid, and BMSB in apple
production. These pests cause quality and yield impacts associated with direct feeding damage
and mold growth due to honeydew secretions. Alternatives generally consist of pyrethroids,
organophosphates, and other neonicotinoids (such as imidacloprid and acetamiprid).
For more information, refer to Usage, Pest Management Benefits, and Possible Impacts of
Potential Mitigation of the Use of the Four Nitroguanidine Neonicotinoids in Pome Fruits
(Apple, Pear) available in the docket.
Rice
The primary use of thiamethoxam and clothianidin is via seed. Foliar applications of clothianidin
target the many of the same early season pests as seed treatment applications (e.g., rice water
weevil, chinch bugs, aphids); therefore, foliar applications likely only occur when seed
treatments are not used. Foliar applications of clothianidin occur between emergence and early
tillering on less than 1,000 acres of rice annually. Depending on the target pest, foliar alternatives
to clothianidin include pyrethroids, diflubenzuron, and neonicotinoid and chlorantraniliprole
seed treatments, depending on the target pest.
For more information, refer to Usage and Benefits of Neonicotinoid Insecticides in Rice and
Response to Comments, available in the docket.
Seed Treatments
Clothianidin and thiamethoxam are currently registered as a seed treatment for multiple field
crops, such as canola, corn, cotton, soybean, sugarbeet, rice, and wheat, and vegetable crops,
such as brassica, carrots, cucurbits, lettuce, and onion. The highest usage is on corn and soybean,
simply by virtue of the large number of acres planted.
Clothianidin and thiamethoxam, along with imidacloprid, are some of only a few insecticidal
seed treatments available. The neonicotinoids are valuable tools because they have both contact
and systemic activity. Thus, they control both soil pests and above ground pests that attack early
stages of the crop. Soil pests include corn rootworms, wireworms, grape colaspis, and maggots,
but there are also many soil pests that are not well-identified. It is difficult to scout for soil pests
in advance of planting and their presence is often hard to predict. Damage can be extensive; soil
pests may attack the seed and/or developing roots and sprouts resulting in poor stand
establishment and substantial yield reductions. Above ground pests such as aphids, leafhoppers,
and thrips feed on newly emerged seedlings. In addition to direct feeding damage, such pests can
transmit diseases. Depending on the crop, other pests include Hessian fly, leafminers, beetles,
and the bagrada bug. As with soil pests, damage to seedlings can result in poor stands and
substantial yield reductions.
Imidacloprid would be the most likely alternative for clothianidin and thiamethoxam seed
treatments where imidacloprid is registered. A few other insecticides are available for a limited
number of sites. For example, chlorpyrifos is registered for treating wheat, sorghum, and some
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vegetable seeds; acetamiprid is registered for canola seed; and cyromazine is used to treat some
vegetable seeds. Pyrethroids, such as permethrin and cyfluthrin, are registered for some sites as
well. None of these, except for acetamiprid, has systemic activity and would only control soil
pests. Chlorantraniliprole has limited systemic activity and only controls some of the insects
controlled by noenicitinoid seed treatments in rice seed. At-plant soil applications may be used in
lieu of seed treatments. Application rates are higher than for seed treatments, increasing chemical
costs, but a larger zone around the seed may be protected from soil pests. Common insecticides
applied at-plant include various carbamates, organophosphates, pyrethroids, and neonicotinoids.
For above ground pests, insecticide applications immediately after the crop emerges. Compared
to seed treatments, application rates and chemical costs are higher, and the growers are likely to
incur additional equipment and labor costs to make the application.
For more information, refer to Usage and Benefits of Neonicotinoid Insecticides in Rice and
Response to Comments, and Benefits and Impacts of Potential Mitigation for Neonicotinoid Seed
Treatments on Small Grains, Vegetables, and Sugarbeet Crops available in the docket.
Stone Fruit
Clothianidin and thiamethoxam each account for about 6% of the peach/nectarine crop treated
(9,000 and 11,500 total acres treated, respectively). Among stone fruit crops, clothianidin is
registered only for peaches; thiamethoxam is registered for the entire crop group. Thiamethoxam
is used to a fairly large extent in cherries (23% average annual crop treated at 49,300 total acres
treated).
Important stone fruit pests targeted by clothianidin and thiamethoxam include the plum curculio,
aphids, plant bugs, stink bugs, June beetles, and Oriental fruit moth. Treatments for all these
pests is typically done soon after petal fall or close to harvest to avoid insect contamination of
fruit. Alternative insecticides currently used or recommended include, carbamates,
organophosphates, and pyrethroids, other nitroguanidine neonicotinoids (mainly imidacloprid),
and the chloropyridinyl neonicotinoid acetamiprid. Use of these chemicals is likely to rise in the
absence of clothianidin or thiamethoxam.
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).
Turf and Ornamentals
Clothianidin and thiamethoxam have limited use on turf and ornamentals, where professional
applicators reported that these two active ingredients were applied on approximately 3% of the
acres treated. Clothianidin and thiamethoxam were reported to be important rotation partners for
the management of southern chinch bugs in St. Augustine grass. Neonicotinoids are typically
important to managing aphids, borers, white grubs, armored scales and whiteflies in the
management of turf and ornamentals. Alternatives to clothianidin and thiamethoxam include
other neonicotinoid chemistries (namely imidacloprid and dinotefuran), pyrethroids,
organophosphates, avermectins, carbaryl and diamides.
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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.
IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION
A. Proposed Risk Mitigation and Regulatory Rationale
As discussed previously, EPA recognizes that the neonicotinoids, including clothianidin and
thiamethoxam, are a key tool for growers that provide unique and effective pest control.
However, the agency has identified ecological risks of concern, particularly to pollinators and
aquatic invertebrates, as a result of many of the same attributes that make the neonicotinoids
effective pest management tools. Risk mitigation measures are being proposed to address
ecological risks of concern identified for pollinators, birds, mammals, and to aquatic
invertebrates; and human health risks of concern to occupational handlers from certain
clothianidin and thiamethoxam uses, as described in Section III.
There are human health exceedances identified for several occupational use scenarios. EPA is
proposing to mitigate these risks through the requirement of additional Personal Protection
Equipment (PPE) such as gloves, respirators, or requiring closed loading systems for seed
treatment on labels. Technical registrants are in general agreement with the proposed label
changes that will significantly reduce, and eliminate in many scenarios, potential exposure to
workers.
There are significant exceedances noted for honeybees. The protection of honeybee colonies is
particularly important as, although honeybees are not native to the United States, they play a
critical role in the pollination needs of many U.S. crops. While honeybees are often the focus,
non-honeybees such as bumble bees, leafcutter bees, and blue orchard bees also play a unique
and important role in commercial pollination services, and therefore are also important to protect
both bees and agriculture. Additionally, it is important to put forth mitigation that reduces impact
to wild native species of bees, as well as honeybees. Rate reductions for certain crops where bee
exposure exists or crop stage restrictions that limit exposure during critical periods in the
growing season, are expected to have the highest potential impact in reducing risks to all bees.
Due to the persistence of neonicotinoids in the environment, there are also potential exceedances
to bees noted for clothianidin and thiamethoxam from usage on poultry litter in chicken houses at
the maximum rate and number of applications annually. Once applied, this litter can be taken out
of the chicken houses and utilized as fertilizer on agricultural fields, allowing for exposure to
bees. The agency is proposing to mitigate these potential risks by reducing the number of poultry
house (whole house) applications allowed annually for clothianidin and thiamethoxam.
There are potential risks to birds and small mammals associated with seeds that are coated with
neonicotinoids. Mitigation was considered with the understanding of the high benefits associated
with seed treatment uses (e.g., early-stage crop protection from soil and above-ground pests),
which have the potential to reduce overall neonicotinoid exposure and offer a lower overall risk
profile compared to foliar uses. The agency is proposing additional advisory label language,
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amplifying Best Management Practices (BMPs), and education programs to help inform farmers
about the importance of picking up spilled seed, in order to reduce overall exposure to birds and
mammals. High-tech planting equipment using GPS and computer controls is becoming
increasingly common in the U.S., and these technologies also help decrease incidence of spills
over older, human-operated equipment.
Potential risks to aquatic invertebrates, which fill a foundational role in ecological food webs, are
a concern. EPA is proposing several measures for reducing overall exposure including targeted
annual application rate reductions and drift and runoff mitigation.
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 dollars16. 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
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 drafting its mitigation strategy in order to
gain a better grasp of growing practices and potential benefits. EPA also conducted an analysis
of common or rare application rates, which was helpful in identifying when conservative
assumptions were made in the risk assessments regarding maximum rates. This analysis also
allowed the agency to determine where targeted rate reductions would decrease overall potential
risks, while minimizing potential impacts to users. Proposed 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 to address potential risks posed by current registered uses of
clothianidin and/or thiamethoxam through the following risk mitigation measures:
• Cancelling certain clothianidin uses
• Restricting certain thiamethoxam uses
• Requiring additional PPE
16 USD A, National Agricultural Statistics Service (NASS), Agricultural Statistics Board. (2018).
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• Reducing maximum application rates or restricting applications during pre-bloom and/or
bloom, targeting certain uses with potentially higher pollinator risks and lower benefits
• Preserving the current restrictions for application at-bloom
• Requiring additional label language reducing use by homeowners
• Applying targeted rate reductions for higher risk uses
• Requiring additional spray drift and runoff reduction label language
• Promoting voluntary stewardship efforts to encourage the use of best management
practices, education, and outreach to applicators and beekeepers
In selecting appropriate mitigation, EPA considered the benefits of the use of clothianidin and/or
thiamethoxam to determine whether any risks present unreasonable adverse effects. For many
uses, the benefits are very high. In contrast, significant risks of concern were noted for certain
crops. Due to the potential impact to growers' ability to address certain critical pest issues, in
accordance with FIFRA's requirement to EPA to take into account the benefits of the use of
pesticides in its decision-making, there are cases where the EPA is not proposing risk mitigation.
An example of a crop in which the benefits of clothianidin and/or thiamethoxam were weighed
against potential impacts of mitigation was citrus crops, where neonicotinoids, including
clothianidin and thiamethoxam, are a key element in programs to control the ACP, an invasive
pest that transmits HLB, a devastating and incurable disease. See section III.C. for more
information. Additionally, EPA considered the overall extent and likelihood of exposure of
certain risks of concern. For example, tree injections showed significant risk extending into the
following growing season. However, they are an expensive and relatively infrequently used
method to prevent tree loss. Due to the low amount of overall usage and strong benefits of the
tree injection use, the agency is not proposing risk mitigation.
The proposed mitigation does not eliminate all potential risks of concern from the use of
clothianidin or thiamethoxam, however, the proposed mitigation reduces the overall potential of
risk and/or exposure. The agency finds the remaining risks to be reasonable under FIFRA, given
the benefits of using clothianidin and thiamethoxam. The EPA is also proposing label changes to
address general labeling improvements for all clothianidin and thiamethoxam products and uses.
1. Cancellation of Clothianidin Uses on Bulb Vegetables
The agency is proposing that cancellation of clothianidin use on bulbs is necessary in order to
mitigate potential exceedances to aquatic invertebrates. The highest neonicotinoid exceedances
to aquatic invertebrates from bulb use reached an RQ of 556. A benefits assessment was
available for this use, which showed limited usage of neonicotinoids with no usage reported for
clothianidin. Although the benefits assessment noted that there are some benefits of
neonicotinoid use on bulbs in targeting thrips, alternatives to the neonicotinoids remain available
for use on bulbs. In consideration of the high potential risk exceedances and the relatively low
expected impacts to bulb growers, EPA is proposing that cancellation of these uses is necessary.
2. Thiamethoxam Use Restrictions for Risks to Occupational Handlers
As noted in Section III.A.l. of this PID, potential risks of concern have been identified for
occupational handlers associated with:
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• Mixing/loading/applying dry flowable formulations of thiamethoxam for application via
backpack sprayer for poultry house applications
• Mixing/loading/applying dry flowable formulations of thiamethoxam for application via
mechanically-pressurized handgun to livestock houses, horse barns, and feed lots
These potential risks exceed the EPA's level of concern even when maximum PPE is considered.
Therefore, to protect the health of occupational handlers of thiamethoxam, the agency is
proposing to restrict all uses for these two use scenarios: 1) DF formulations of thiamethoxam
via backpack sprayer for poultry house applications, 2) DF formulations of thiamethoxam via
mechanically-pressurized handgun for livestock houses, horse barns, and feed lot applications. It
should be noted that even after these proposed restrictions, applicators would still have the
option of making thiamethoxam applications in poultry houses, livestock houses, horse barns,
and feed lots using alternative application technologies (e.g. manually-pressurized handwands)
as allowed on labels, taking into account the various mitigation updates proposed in this PID.
3. Glove and Respirator Requirements for Certain Occupational Handlers
Human health exceedances are identified for clothianidin and thiamethoxam for several
registered agricultural, seed treatment and non-agricultural (e.g. spray applications in
commercial buildings) use scenarios. EPA is proposing to mitigate these risks by adding
requirements for Personal Protection Equipment (PPE) such as gloves and/or respirator, along
with requiring certain application restrictions for commercial facilities.
Most occupational handler risk estimates were not of concern with current baseline attire or with
PPE, however, there were some scenarios where risks of concern were identified for workers
performing activities (e.g., mixing, loading and/or applying). To mitigate potential dermal and/or
inhalation risks to handlers, the agency is proposing the following:
For Clothianidin:
• Proposed uses to add requirement for gloves and a respirator:
o Corn - seed treatment use (e.g., loading, applying, sewing, bagging, etc.)
o Commercial Buildings - liquid (i.e. aerosol cans) application
• Proposed uses to add requirement for gloves:
o Livestock housing (i.e., non-poultry, barns/feedlots) - Mixing/loading/applying
liquid formulation via mechanically-pressurized handgun
As stated in Section III. 1 of this PID, there were several potential risks of concern to
occupational handlers, including, dermal and inhalation scenarios for corn seed treatment
handlers performing several activities (e.g. loading, applying, sewing, bagging, etc.). The MOE
is 71 (LOC = 100) with the current label-required single layer. The agency is therefore proposing
the use of a respirator and updating the glove statements for all handlers of clothianidin corn seed
treatments. The MOE for the liquid application via aerosol can to treat for bed bugs in
commercial buildings was 48. The agency is proposing a label requirement for gloves and a
respirator, which results in no risk of concern. The MOE for mixers/loaders/applicators of liquid
formulations via mechanically-pressurized handguns in livestock housing was 80. The agency
proposes a glove requirement, which no longer results in a risk of concern.
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For Thiamethoxam:
• Proposed uses to add requirement for gloves and a respirator:
o Sod - Mixing/loading dry flowable (DF) formulations for aerial application
o High-acreage field crops (e.g., barley, wheat, rice, cotton, corn) - Mixing/loading
DF formulations for aerial application
o Warehouses - Mixing/loading/applying liquid formulations via mechanically-
pressurized handgun
o Poultry Houses - Mixing/loading/applying DF formulations via mechanically-
pressurized handgun
• Proposed uses to add requirement for gloves:
o Warehouses - Mixing/loading/applying liquid crack and crevice (C&C) treatment
via manually-pressurized handwand
o Childcare centers, schools and institutions - Mixing/loading/applying liquid C&C
treatment via manually-pressurized handwand
o Residential living spaces - Mixing/loading/applying liquid C&C treatment via
manually-pressurized handwand
o Mounds or nests - Mixing/loading/applying liquid formulations via manually-
pressurized handwand
o Mounds or nests - Mixing/loading/applying DF formulations via manually-
pressurized handgun
o Landscaping trees, shrubs and bushes - Mixing/1 oading/applying DF formulations
via mechanically-pressurized handgun
As noted in Section III. 1 of this PID, there were several potential risks of concern to
occupational handlers from thiamethoxam uses. Potential risks of concern were identified for
mixers/loaders of DF formulations for aerial applications to sod and high-acreage field crops
(sod, MOE = 44; high-acreage field crops, MOE = 53). EPA proposes requiring gloves and a
respirator, which resolves these potential risks of concern. The MOE for
mixers/loaders/applicators of liquid formulations using a mechanically-pressurized handgun to
warehouses was 55. This scenario no longer results in a risk of concern with the addition of
gloves and a respirator. A potential risk of concern was identified for mixers/loaders/applicators
of DF formulations via mechanically-pressurized handguns to poultry houses (MOE = 57),
which is eliminated with the addition of gloves and a respirator.
Also, there were six non-agricultural use scenarios with potential risks of concern for
mixers/loaders/applicators. For liquid formulations applied via manually-pressurized handwands,
there were potential risks of concern associated with crack & crevice (C&C) applications in
warehouses (MOE = 91); C&C applications in childcare centers, schools and institutions (MOE
= 91); C&C applications to residential living spaces (MOE = 91); and applications to mounds or
nests (MOE = 6.7). For these use scenarios, the agency proposes a glove requirement to the label,
which eliminates these risks. The MOE for DF formulations applied via manually-pressurized
handgun to mounds or nests was 87. The addition of gloves negates this potential risk. Finally, a
potential risk of concern was identified for DF formulations applied via mechanically-
pressurized handgun to landscaping trees, shrubs and bushes (MOE = 65). Therefore, the agency
proposes requiring gloves, which results in no risk of concern.
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In addition, the agency is proposing to update the glove statements currently on labels to be
consistent with the Label Review Manual. The proposed new language does not fundamentally
change the personal protective equipment that workers need to use, and therefore should impose
no impacts on users. With cooperation from stakeholders, the proposed label changes would
significantly reduce, and eliminate in many scenarios, risks of concern to workers.
The EPA has recently required fit testing, training, and medical evaluations17 for all handlers
who are required to wear respirators and whose work falls within the scope of the WPS.18 If a
clothianidin handler currently does not have a respirator, an additional cost will be incurred by
the handler or the handler's employer, which includes the cost of the respirator plus, for WPS-
covered products, the cost for a respirator fit test, training, and medical exam.
Respirator costs are extremely variable depending upon the protection level desired,
disposability, comfort, and the kinds of vapors and particulates being filtered. Based on available
information that the EPA has, the average cost of a disposable particulate filtering face-piece
respirator) is about $5 and an elastomeric half mask respirator is $35, with their replacement
cartridges averaging around $19.19 The agency expects that the average cost of a particulate
filtering facepiece respirator is lower than the average cost of an elastomeric half mask
respirator. The estimated cost of a respirator fit test, training and medical exam is about $180
annually.20 The impact of the proposed respirator requirement is likely to be substantially lower
for a clothianidin or thiamethoxam handler who is already using a respirator because the handler
or handler's employer uses other chemicals requiring a respirator in the production system or as
part of the business {i.e., the handler or employer will only incur the cost of purchasing filters for
the respirator on a more frequent basis). Respirator fit tests are currently required by the
Occupational Safety and Health Administration (OSHA) for other occupational settings to ensure
proper protection.21
The EPA acknowledges that requiring a respirator and the associated fit testing, training, and
medical evaluation places a burden on handlers or employers. However, the proper fit and use of
respirators is essential to accomplish the protections respirators are intended to provide. In
estimating the inhalation risks, and the risk reduction associated with different respirators, the
EPA's human health risk assessments assume National Institute for Occupational Safety and
Health (NIOSH) protection factors {i.e., respirators are used according to OSHA's standards). If
the respirator does not fit properly, use of clothianidin and thiamethoxam may cause
unreasonable adverse effects on the pesticide handler.
17 Fit testing, training, and medical evaluations must be conducted according to OSHA regulations 29 CFR §
1910.134, 29 CFR § 1910.134(k)(l)(i) through(vi), and 29 CFR § 1910.134, respectively.
18 40 CFR 170 (see also Appendix A of chapter 10 of the Label Review Manual, available at
https://www.epa.gov/pesticide-registration/label-review-mannal')
19Gempler's. 2016. Commercial-Grade Outdoor Work Gear Online Catalogue. Accessed online on August 26, 2016,
at http://www. gemplers.com/respirators
20 Economic Analysis of the Agricultural Worker Protection Standard Revisions. Biological and Economic Analysis
Division, Office of Pesticide Programs, U.S. EPA. 2015. p. 205. Available at www.regnlations.gov. docket number
EPA-HQ-OPP-2011 -0184-2522
21 29 CFR § 1910.134
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4. Closed System Requirement for Thiamethoxam Corn Seed Treatments
As noted in Section III.A.l. of this PID, potential risks of concern have been identified for
occupational handlers from the use of thiamethoxam for corn seed treatments in commercial
facilities. Even with maximum PPE (double layer of clothing, gloves, and an elastomeric half-
mask respirator) required for these uses, certain field, pop, and sweet corn seed treatment
scenarios still have MOEs of concern for certain activities, ranging from 13-43. These MOEs
are well below the agency's level of concern of 100. To protect the health of workers involved in
commercial seed treatments of corn using thiamethoxam, EPA is therefore proposing that the use
of a closed loading system be required for all thiamethoxam corn seed treatments conducted in
commercial facilities. With the addition of a closed loading system, EPA would no longer expect
any potential risks of concern to human health for corn seed treatments of thiamethoxam in
commercial facilities.
EPA is proposing that all thiamethoxam products registered for corn seed treatment uses must
include the following statement on labels:
• "Must be applied by closed system seed treatment application processes when applied in
commercial seed treatment facilities."
EPA identified no risk estimates of concern for corn seed treatment uses of thiamethoxam in the
case of on-farm seed treatments, and mitigation is therefore not being proposed for that use
scenario. The closed system requirement being proposed in this PID is for commercial facilities
only.
5. Poultry House Use Requirements for Clothianidin
Ecological risks of concern for both bees and aquatic invertebrates have been identified as a
result of poultry house uses of clothianidin. Single application rates associated with non-
agricultural uses account for some of the highest application rates, where poultry house
applications were up to 0.49 lbs. a.i./A. There is a potential chronic risk for aquatic invertebrates
from the application of clothianidin to poultry houses (RQs < 7.2). Additionally, soil
amendments of clothianidin-treated poultry litter (from the use in poultry houses) pose a risk
when applied to fields with honeybee attractive plants (e.g., pasture). Screening level RQs for
applications of poultry litter from treated poultry houses resulted in acute and chronic LOC
exceedances for adult bees (RQs = 7 and 70, respectively).
To help mitigate these potential risks, EPA is proposing that the all clothianidin products
registered for poultry house uses must include the following statements:
• "Limit applications to one whole house treatment and 5 perimeter (partial house)
treatments per year."
• "Do not apply to more than 30,000 sq. ft. per year per house."
The goal of these proposed statements is to reduce the total environmental loading of
clothianidin resulting from poultry house uses. Limiting both the number and square footage of
allowable poultry house treatments per year will limit the amount of clothianidin entering the
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environment, when treated poultry litter is removed from poultry houses and used as a soil
amendment in agricultural fields, while still retaining the benefits of clothianidin for poultry
producers as a treatment for darkling beetles and other poultry houses pests. These proposed
limits on poultry house uses of clothianidin will also reduce the exposure of applicators to this
pesticide.
6. Application Rate Reductions
Application rate reductions are being proposed for several uses in order to reduce risks to both
bees and aquatic invertebrates. For pollinators, these rate reductions focus on certain crops with
the highest potential reduction of risks to bees. For bees and aquatic invertebrates, measured rate
reductions are a part of a multi-faceted approach to reducing overall exposure. The additional
approaches include spray drift and runoff reduction language, current application timing
restrictions, and pesticide education and outreach efforts. The goal of these proposed maximum
annual application rate reductions is to reduce the total environmental loading of clothianidin
and/or thiamethoxam resulting from the various uses specified, while still providing growers
with the ability to use these tools as an effective means of pest control.
As part of the assessments of the benefits for the neonicotinoids, EPA also assessed the impacts
of potential mitigation, including the effect of reducing rates. This information was critical in
identifying sites and rates where rate reductions would achieve the greatest reduction in risk
while minimizing the potential impacts on users of clothianidin and/or thiamethoxam. Although
these proposed rate reductions do not eliminate all risks, they are expected to contribute to
reducing risk overall. The benefits of these uses outweigh the remaining reduced risks of
concern.
To help mitigate risks to non-target organisms, EPA is proposing the following reductions in the
maximum allowable annual application rates for foliar and/or soil applications of clothianidin
and thiamethoxam products:
i. Clothianidin
Table 3. Proposed Maximum Annual Application Rates for Clothianidin
Crop/Crop (iroup
C'linvnl K:ilc(M:i\. Aiimiitl)
Proposed Kitlc (Mux. Annunl)
Berries and small fruit
(excluding grape and
strawberry)
Maximum combined annual
application rate, regardless of
formulation type: 0.20 lbs. a.i./A per
year
Maximum combined annual
application rate, regardless of
formulation type: 0.16 lbs. a.i./A per
year
Cotton
Maximum combined annual
application rate, regardless of
formulation type: 0.20 lbs. a.i./A per
year
Maximum combined annual
application rate, regardless of
formulation type: 0.15 lbs. a.i./A per
year
Fruiting Vegetables
Foliar: 0.20 lbs. a.i./A per year
Foliar: 0.17 lbs. a.i./A per year
Pome Fruit
Foliar: 0.20 lbs. a.i./A per year
Foliar: 0.16 lbs. a.i./A per year
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Crop/Crop (iroup
C'linvnl K:ilc(M:i\. Aiimiitl)
Proposed Kitlc (Mux. Annunl)
Production/Commercial
Ornamentals
Foliar and soil: 0.40 lbs. a.i./A per year
Foliar and soil: 0.30 lbs. a.i./A per
year
Tree Nuts
Foliar: 0.20 lbs. a.i./A per year
Soil: 0.40 lbs. a.i./A per year
Foliar: 0.16 lbs. a.i./A per year
Soil: 0.38 lbs. a.i./A per year
Turf
Foliar: 0.40 lbs. a.i./A per year
Foliar: 0.30 lbs. a.i./A per year
Berries and small fruits
In this crop group, clothianidin is registered for use only on cranberry and blueberry. EPA is
proposing to reduce the current maximum annual application rate, regardless of the application
method, from 0.20 lbs. a.i./A per year to 0.16 lbs. a.i./A per year. This mitigation is being
proposed to address aquatic invertebrate exceedances.
Potential risks to aquatic invertebrates are noted for foliar applications of clothianidin to
cranberries, with RQs up to 96. The agency is uncertain as to the impact this mitigation will have
on growers. Clothianidin was registered for use on cranberries and blueberries in 2016 and usage
data are not available. EPA encourages comment on the feasibility of pest control at these rates
and the extent to which growers' production practices will be affected.
Cotton
For cotton, EPA is proposing reducing the current maximum combined rate of 0.20 lbs. a.i./A per
year, regardless of formulation type, and reducing it to 0.15 lbs. a.i./A per year applied annually.
This mitigation measure is being proposed to address pollinator and aquatic invertebrate risk
exceedances.
Potential risks from cotton foliar use is considered under the strongest category of evidence for
pollinator exceedances. Acute and chronic foliar exceedances are identified for adult bees (RQs
= 346 and 2,729, respectively). Foliar applications of clothianidin resulted in chronic RQs that
ranged from 30 to 59 for freshwater aquatic invertebrates. Cotton is considered one of the major
drivers of potential pollinator risk. However, clothianidin is also considered highly beneficial to
cotton growers throughout the growing season for a variety of pests.
Available usage data show that an average of 8,900 lbs. of clothianidin is applied as a foliar
treatment each year; less than two percent of the cotton crop is treated with a foliar application of
clothianidin, although over 12% of the cotton crop in California and Arizona receives foliar
treatment. Nationally, the average annual application rate is 0.097 lbs. a.i./A per year, which is
well below the proposed new annual rate of 0.15 lbs. a.i./A per year, however, annual application
rates of 0.160 lbs. a.i./A per year are observed on about 13% of the acres treated with
clothianidin. With consideration of current usage and typical rates, these rate reductions are
expected to have impact on some users. The proposed rate would allow only one application at
the maximum single application of 0.10 lb a.i./A per year. Growers who would normally make a
second application may have to use alternative insecticides.
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Fruiting Vegetables
For the fruiting vegetables crop group, EPA is proposing reducing the current maximum foliar
annual application rate from 0.20 lbs. a.i./A per year to 0.17 lbs. a.i./A per year. This rate
reduction is targeted at reducing potential risk to aquatic invertebrates.
Potential risks to aquatic invertebrates are noted for both foliar and soil applications of
clothianidin from fruiting vegetable use, with RQs ranging up to 768 and the highest
exceedances identified for foliar uses. The agency expects that the potential impacts to growers
from this mitigation will be low. According to usage data, annual rates above 0.12 lbs. a.i./A per
year are used on only about one percent of the area treated with clothianidin, inclusive of soil
applications. The proposed rate allows at least two foliar applications of clothianidin per year.
Pome Fruit
For pome fruit, EPA is proposing to reduce the current maximum annual foliar application rate
of 0.20 lbs. a.i./A per year to 0.16/year lbs. a.i./A. This mitigation is being proposed for aquatic
invertebrate risk exceedances.
Potential risks to aquatic invertebrates are noted for applications of clothianidin from pome fruit
use, with a chronic RQ of 108. A rate reduction of clothianidin in apple will impact about 11% of
the Eastern apple crop acreage that use clothianidin to control plum curculio and brown
marmorated stink bug. For apple orchards treated with clothianidin, approximately 90% of the
base acres are treated with average annual rates of 0.16 lbs. a.i./A per year (MRD, 2013-2017).
Thus, a reduction in the annual rate is likely to affect about 10% of Eastern apple crop acreage
facing severe pest pressure. For pear, about 1% of the crop acreage is treated with clothianidin to
control pear psylla and mealybug. Of the pear crop acreage treated with clothianidin, nearly 98%
are treated at the maximum annual rate of 0.20 lbs. a.i./A per year. For these pear crops, a rate
reduction is likely to have a significant impact on the use clothianidin. Benefits are considered
high for pome fruit use of clothianidin. Alternatives to clothianidin in pome fruit include
organophosphates, pyrethroids, and other neonicotinoids (such as imidacloprid and acetamiprid).
Production/Commercial Ornamentals
For production/commercial ornamentals, EPA is proposing a reduction of the current maximum
annual foliar and soil application rate from 0.40 lbs. a.i./A per year to 0.30 lbs. a.i./A per year.
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 greenhouses/nurseries. This
mitigation does not apply to indoor commercial nursery, Christmas trees, greenhouse uses, or
forestry use on public land and quarantine application by USD A.
Potential risks from ornamentals are considered under the strongest category of evidence for
pollinator exceedances based on bridged residue studies and three bee kill incident reports (see
Final Bee Risk Assessment to Support the Registration Review of Clothianidin and
Thiamethoxam). Also, potential risks to aquatic invertebrates are noted for foliar and soil
applications, with chronic RQs ranging from 30 to 86 for foliar applications and from 29 to 83
for soil applications. Benefits are considered high for the use of neonicotinoids, however,
clothianidin is one of the least used neonicotinoid active ingredients for these use sites (3%).
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Other than the available 2014 Aglnfomatics report and review, usage data is limited. This rate
reduction is considered to have potentially moderate impacts on current usage.
Tree nut
For tree nuts, EPA proposes reducing the current maximum foliar annual application rate from
0.20 lbs. a.i./A per year to 0.166 lbs. a.i./A per year, and a reduction in the maximum soil annual
application rate from 0.40 lbs. a.i./A per year to 0.38 lbs. a.i./A per year. This mitigation measure
is being proposed for aquatic invertebrate exceedances.
Potential risks from tree nut uses are noted for aquatic invertebrates. Aquatic invertebrate
exceedances for foliar applications ranged from 256 to 433 and for soil applications from 18 to
84. Highest benefits of clothianidin use on tree nuts are in pecans where PCTs may be as high as
10 and average around 5.4 The average annual rate is 0.127 lbs. a.i./A per year. Therefore, the
proposed annual foliar rate reduction is expected to have low impact on growers. Reductions in
the annual soil application rates are expected to have low impacts on current usage; soil
applications appear rare to nonexistent.
Turf
For turf, EPA is proposing reducing the current maximum annual foliar and soil application rate
from 0.40 lbs. a.i./A per year to 0.30 lbs. a.i./A per year. This rate reduction is targeted at
reducing potential risk to aquatic invertebrates.
Potential risks to aquatic invertebrates are noted for foliar applications of clothianidin on turf,
where RQs ranged from 46 to 71. There is also moderate evidence (high initial residues and a
bee kill incident) indicating that use of clothianidin on attractive flowering weed species presents
potential risk to honeybee colonies. Benefits are considered high for the use of neonicotinoids,
however, clothianidin is one of the least used neonicotinoid active ingredients for this use site.
Other than the available 2014 Aglnfomatics report and review, usage data is limited.
Aglnfomatics reported that clothianidin is important for southern chinch bug control in St.
Augustine grass, and a rate reduction of clothianidin in turf may negatively impact turf
management efficacy against southern chinch bugs in St. Augustine grass. Overall, this rate
reduction is considered to have potentially moderate impact on turf given the current usage.
ii. Thiamethoxam
Table 4. Proposed Maximum Annual Application Rat
es for Thiamethoxam
Crop/Crop
(i roup
Ciirivnt Rale (M;i\. Annual)
Proposed Rale (Mux. Annual)
Berries and
Small Fruit
(Foliar
Applications)
Bushberrv Subgroup (including but not limited to highbush blucberrv. gooseberry, etc.)
0.188 lbs. a.i./A per year
0.15 lbs. a.i./A per year
Caneberrv Subgroup (including but not limited to blackberry, raspberry, etc.)
0.094 lbs. a.i./A per year
0.07 lbs. a.i./A per year
Low Growing Berry Subgroup (including but not limited to lowbush blueberry,
strawberry, cranberry, etc.)
0.188 lbs. a.i./A per year
0.15 lbs. a.i./A per year
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Crop/Crop
(i roup
Ciirivnt Rale (M;i\. Annual)
Proposed Rale (Mux. Annual)
Small Fruit Vine Climbing Subgroup (including but not limited to mavpop: excluding
grape, fuzzv kiwi fruit and gooseberry)
0.109 lbs. a.i./A per year
0.09 lbs. a.i./A per year
Berries and
Small Fruit
(Soil
Applications)
Bushberrv Subgroup (including but not limited to highbush blueberry, gooseberry, etc.)
0.188 lbs. a.i./A per year
0.15 lbs. a.i./A per year
Low Growing Berry Subgroup (including but not limited to lowbush blueberry,
strawberry, cranberry, etc.)
0.188 lbs. a.i./A per year
0.15 lbs. a.i./A per year
Small Fruit Vine Climbing Subgroup (including but not limited to maypop: excluding
grape, fuzzy kiwi fruit and gooseberry)
0.266 lbs. a.i./A per year
0.22 lbs. a.i./A per year
Cotton
Maximum combined annual application
rate, regardless of formulation type: 0.125
lbs. a.i./A per year
Maximum combined annual application
rate, regardless of formulation type: 0.09
lbs. a.i./A per year
Berries and small fruits
The berries and small fruits group includes several subgroups of crops such as bushberry,
caneberry, low growing berry, and vine climbing small fruit, but not including grape. EPA is
proposing reducing the current maximum foliar annual application rate for the bushberry
subgroup from 0.188 lbs. a.i./A per year to 0.15 lbs. a.i./A per year; the caneberry subgroup from
0.094 lbs. a.i./A per year to 0.07 lbs. a.i./A per year; the low growing berry subgroup from 0.188
lbs. a.i./A per year to 0.15 lbs. a.i./A per year; and the small fruit vine climbing subgroup from
0.109 lbs. a.i./A per year to 0.09 lbs. a.i./A per year.
The agency is also proposing reducing the current maximum soil annual application rate for the
bushberry subgroup from 0.188 lbs. a.i./A per year to 0.15 lbs. a.i./A per year; the low growing
berry subgroup from 0.188 lbs. a.i./A per year to 0.15 lbs. a.i./A per year; and the small fruit vine
climbing subgroup from 0.266 lbs. a.i./A per year to 0.22 lbs. a.i./A per year. This mitigation is
being proposed to reduce potential pollinator risk.
Potential risks from foliar and soil, pre-bloom applications to berries is considered under the
strongest category of evidence for pollinator exceedances. Foliar exceedances for adult
pollinators are identified with an acute RQ of 170 and a chronic RQ of 860. A foliar chronic
exceedance is also identified for larval bees (RQ = 35). Soil exceedances to adult pollinators are
identified with an acute RQ of 15 and a chronic RQ of 71. A soil exceedance is also identified
for larval bees (Chronic RQ = 3.9). Benefits are also considered substantial for thiamethoxam's
use on berries and small fruit, where PCTs ranged 7 - 32%. The agency expects a potential
moderate impact on usage.
The agency expects variable impacts on growers, depending on the crop. Growers of caneberry
are most likely to experience an impact; the average annual application rate is 0.092 lbs. a.i./A
per year {i.e., most users apply thiamethoxam at or near the current maximum application rate).
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In some years, 10% of blueberry acres are treated at rates of 0.163 lbs. a.i./A per year, implying
that some growers may face potential sporadic constraints. However, proposed rates would allow
strawberry growers at least two applications per year and is likely to affect very few acres.
Cotton
For cotton, EPA is proposing to reduce the current maximum combined rate of 0.125 lbs. a.i./A
per year, regardless of formulation type, and reducing it to 0.09 lbs. a.i./A per year applied
annually. This mitigation is being proposed to reduce potential pollinator risk.
Potential risks from cotton foliar use is considered under the strongest category of evidence for
pollinator exceedances. There are acute and chronic foliar exceedances for adult bees (RQs = 53
and 66, respectively). There is also a chronic foliar exceedance for larval bees (RQ = 2.7). Cotton
is considered to be one of the major drivers of potential pollinator risk. Thiamethoxam is also
considered highly beneficial to cotton growers throughout the growing season for a variety of
pests.
Available usage data show that an average of 62,300 lbs. of thiamethoxam is applied as a foliar
treatment each year to 1.5 million acres. Also, the average annual application rate is 0.065 lbs.
a.i./A per year, which is well below the proposed new annual rate of 0.098 lbs. a.i./A; rates of
0.10 lbs. a.i./A per year are used on about 8% of the acres. With consideration of current usage
and typical rates, these rate reductions may impact some users. The proposed rate would allow
only one application at the maximum single application of 0.063 lbs. a.i./A. Growers who would
normally make a second application may have to use alternative insecticides.
7. Crop Stage Restrictions
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 are easily identifiable by growers.
i. Clothianidin
Table 5. Proposed Crop Stage-based Application Restrictions for Clothianidin
Crop/Crop (iroup
Proposed Kisk Mitigation
Cucurbits
The agency is proposing a crop stage restriction for both foliar and
soil labels, to prohibit use from vining to harvest or after the
emergence of the first true (non-cotyledon) leaf
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Crop/Crop (iroup
Proposed Risk Miligiilion
Avocado, banana, dates
and olives
The agency is proposing a crop stage restriction for foliar labels,
to prohibit foliar application pre-bloom until after flowering is
complete and all petals have fallen off.
Cucurbits
For cucurbits, EPA is proposing a crop stage restriction for both foliar and soil labels, to prohibit
use on vining to harvest or after the emergence of the first true (non-cotyledon) leaf. The
applicator has a choice to either utilize crop stage frame of reference (e.g., vining to harvest or
first true (non-cotyledon) leaf). The agency encourages input from stakeholders regarding the
best identifier for crop stage.
Potential risks to pollinators are noted under the strongest evidence of risk for cucurbit foliar
uses, and under the moderate evidence of risk for cucurbit soil uses. Foliar RQ exceedances for
adult pollinators are identified with an acute RQ of 0.5 and a chronic RQ of 4.1. RQ exceedances
for adult pollinators from soil applications are identified for both acute and chronic (RQs = 5.2
and 53, respectively). Also, there is an RQ exceedance from soil application for larval pollinators
(max larval RQ = 2.16). Neonicotinoid residue data indicate that residues remained in the plant
at high levels for weeks after application as seen by the lowest observed adverse effect
concentration (LOAEC) shown reached at 19 days after application for foliar and 47 days for
soil. Available benefits information identified clothianidin's usage as mostly negligible, and
neonicotinoids are not typically used after vining. Therefore, a restriction from vining to harvest
is not likely to significantly impact current usage.
Tropical and Subtropical Fruit
For avocado, banana, dates, and olives; EPA is proposing a crop stage restriction for foliar use,
to prohibit foliar application pre-bloom until after flowering is complete and all petals have
fallen off. The agency is not proposing crop stage restrictions for other fruit trees in this crop
group.
Potential risks to pollinators are noted under the weakest evidence of risk for foliar and soil post-
bloom. Mitigation is being proposed on crops in this group that are considered to have higher
acreage and to be pollinator attractive, and no mitigation is being done on low acreage or non-
bee attractive crops. Clothiani din's usage varies across the crops in the tropical and subtropical
fruit group, with relatively high usage on fig and pomegranate trees. From the information
available on avocado, dates, and olives, the agency anticipates low impacts to users. California
accounts for about 90% of total U.S. acreage of these crops and, based on data from California
Pesticide Use Reports, usage of clothiani din is rare on avocado, dates, and olives. EPA is
specifically requesting public comments to better understand potential impacts on banana
production.
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ii. Thiamethoxam
Table 6. Proposed Crop Si
age-based Application Restrictions for Thiamethoxam
C rop/Crop (Iroup
Proposed Mili<>;ilion
Cucurbits
The agency is proposing a crop stage restriction for foliar labels only, to
prohibit use vining to harvest or after the emergence of the first true
(non-cotyledon) leaf.
Fruiting Vegetables
The agency is proposing a crop stage restriction for both foliar and soil
labels, to not apply 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.
Pome Fruit
The agency is proposing crop stage restrictions for foliar labels only, to
not apply from bud-break (also known as "swollen bud stage" in pear or
"silver-tip stage" in apple) until after petal fall is complete.
Stone Fruit
The agency is proposing a crop stage restriction for foliar labels, to
prohibit foliar application from bud break until after petal fall is
complete.
Tree Nuts
The agency is proposing the following crop stage restrictions for foliar
labels only:
For walnuts and pecans: "Do not applv prior to bud break or until after
petal fall is complete."
For other tree nut crops: "Do not applv prior to bloom or until after petal
fall is complete."
Avocado, banana, dates and
olives
The agency is proposing a crop stage restriction for foliar labels, to
prohibit foliar application pre-bloom until after flowering is complete
and all petals have fallen off.
Cucurbits
For cucurbits, EPA is proposing a crop stage restriction for foliar labels, to prohibit use from
vining to harvest or after the emergence of the first true (non-cotyledon) leaf. The applicator has
a choice to utilize either crop stage frame of reference (e.g., vining to harvest or first true (non-
cotyledon) leaf). The agency encourages input from stakeholders regarding the best identifier for
crop stage.
Potential risks to pollinators are noted under the strongest evidence of risk for cucurbit foliar
uses, and under the strongest evidence of risk for cucurbit foliar uses. Foliar exceedances to adult
pollinators are identified with an acute RQ of 23 and a chronic RQ of 1400. Acute and chronic
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risk exceedances to adult pollinators from soil applications are identified (RQs = 4.6 and 23,
respectively). Also, there are chronic foliar and soil RQ exceedances for larval pollinators (larval
RQs = 56 and 1.2, respectively). Neonicotinoid residue data indicate that residues remained in
the plant at high levels for weeks after application as seen by the lowest observed adverse effect
concentration (LOAEC) shown reached at 19 days after application for foliar and 47 days for
soil. According to EPA's assessment, thiamethoxam's usage is primarily at-plant or immediately
after crop emergence. Therefore, a restriction from vining to harvest is likely to have a marginal
impact on current usage.
Fruiting Vegetables
For the fruiting vegetables crop group, EPA is proposing a crop stage restriction for both foliar
and soil labels, to 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, EPA is
also proposing to restrict application after 5 days after planting or transplanting regardless of
application method.
Potential risks to pollinators are noted under the strongest evidence of risk for foliar and under
the moderate evidence of risk for soil uses of pollinator attractive fruiting vegetables. Pollinator
risk exceedances from foliar application are identified with an adult bee acute RQ of 38 and a
chronic RQ of 240; soil application risk exceedances for adult bees are identified for both acute
(RQ = 109) and chronic (RQ = 430). Chronic risk exceedances are also identified for larval bees
from foliar and soil applications (RQs =1.3 and 18, respectively). Benefits are considered to be
high for thiamethoxam's use on fruiting vegetables, where PCTs ranged from 19 - 31%.
Thiamethoxam is particularly important to pepper growers. Applications after crop emergence or
transplanting account for around two-thirds of the neonicotinoid-treated acres of peppers and
tomato acres. Thiamethoxam targets season-long pests. Thrips and leafhopper can target fruit
directly and viral diseases vectored by these pests can seriously impact the development, quality
and/or yield of the harvested fruit. Aside from neonicotinoids, California extension only
recommends carbaryl for leafhopper control; it is not systemic and may have to be applied
multiple times to achieve control throughout the season. Alternatives for thrips include
pyrethroids, OPs, acetamiprid, and cyantraniliprole; oxamyl might provide good systemic control
but EPA has previously proposed cancelling use of oxamyl on tomato.
Pome Fruit
For pome fruit, the agency is proposing crop stage restrictions for foliar labels only. For pears,
the agency proposes to prohibit foliar applications from swollen bud stage until after petal fall is
complete. For non-pear pome fruit (including but not limited to apple), the agency proposes a
prohibition on foliar applications from the silver-tip stage until after petal fall is complete.
Potential risks to pollinators are noted under the strongest evidence of risk for foliar, pre-bloom
applications of thiamethoxam to pome fruit. Acute and chronic foliar exceedances are identified
for adult bees (RQs = 52 and 400, respectively). Additionally, a chronic exceedance is identified
for larval bees (RQ = 18). Foliar exceedances are also identified for freshwater invertebrates
(RQs ranged 5.2 to 5.6). Benefits are also considered to be low to high for thiamethoxam's use
on pome fruit, where PCTs ranged from 1 - 50%. Thiamethoxam is particularly important to
eastern apple growers. Available benefits information identified thiamethoxam as most used
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post-bloom (65 - 80%), therefore, the proposed restrictions are likely to have low to moderate
impact on current usage. Thiamethoxam is the primary control option of plum curculio during
the pre-bloom and bloom period in eastern apple production (accounting for 17 PCT). The
prohibition of thiamethoxam use during this time period will likely lead to an increase in the use
of the leading alternatives, lambda-cyhalothrin and phosmet. There is likely a limited impact to
pear and western apple growers from this restriction.
Stone Fruit
For stone fruit, the agency is proposing crop stage restriction for foliar labels, to prohibit foliar
application from bud break until after petal fall is complete.
Potential risks to pollinators are noted under the strongest evidence of risk for foliar, pre-bloom
applications of thiamethoxam to stone fruit. Acute and chronic foliar exceedances are identified
for adult bees (RQs =1.1 and 5.2, respectively). Foliar RQ exceedances are also identified for
freshwater invertebrates (RQs ranged 5.2 to 5.6). Available benefits information identified
thiamethoxam as most used post-bloom (>80%), therefore, the proposed restrictions are likely to
have low impact on current usage.
Tree Nuts
For tree nuts, EPA is proposing crop stage restrictions for foliar labels. For walnuts and pecans,
the agency proposes to prohibit use prior to bud break or until after petal fall is complete, and for
other tree nut crops, the agency proposes to prohibit use prior to bloom or until after petal fall is
complete. The applicator has a choice to utilize either crop stage frame of reference (e.g., prior to
bud break or until after petal fall is complete). EPA is specifically requesting public comments to
better understand potential impacts from these proposed crop stage restrictions. Available data
for pecans indicates that almost 20% of total acres treated with neonicotinoids occurs prior to or
around bloom although this time period includes a period after bloom and prior to nut swell. The
proposal would allow dormant season applications of thiamethoxam prior to bud break.
Potential risks to pollinators are noted under the strongest evidence of risk for foliar, pre-bloom
applications of thiamethoxam to tree nuts. Residue studies report residue exceedances, where
residues persisted for 13 - 21 days before exceeding the LOAEC, and 21 days before exceeding
the NOAEC. Benefits are also considered low for thiamethoxam's use on tree nuts, where PCTs
are about 1% or less for pecans and pistachios. Given thiamethoxam's minimal use on tree nut
crops, the agency anticipates low impacts on growers.
Tropical and Subtropical Fruit - Avocado, Banana, Dates and Olives
For avocado, banana, dates and olives; EPA is proposing a crop stage restriction for foliar labels,
to prohibit foliar application pre-bloom until after flowering is complete and all petals have
fallen off. The agency is not proposing crop stage restrictions for other fruit trees in this crop
group.
Potential risks to pollinators are noted under the strongest evidence of risk for foliar, pre-bloom
applications of thiamethoxam. Mitigation is being proposed on crops in this group that are
considered both higher acreage and pollinator attractive, no mitigation is being done on low
usage or non-bee attractive crops. Neonicotinoids are generally considered important to
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pomegranate production (PCT = -46%, neonicotinoids). From the information available on
avocado, dates, and olives, the agency anticipates low impacts to users. California accounts for
about 90% of total U.S. acreage of these crops and, based on data from California Pesticide Use
Reports, usage of thiamethoxam is rare on avocado, dates, and olives. EPA is specifically
requesting public comments to better understand potential impacts on banana production.
8. Advisory Statements for Clothianidin and Thiamethoxam Seed Treatment Uses
Acute and chronic dietary risks of concern have been identified for birds and mammals exposed
to clothianidin and/or thiamethoxam treated seeds. The potential for risk depends on the size of
the animal and the treated seed. However, the risk potential is also dependent on factors affecting
exposure (e.g. application rates, timing, seed depth).
To help mitigate these risks, EPA is proposing that all pesticide products that contain either
clothianidin and/or thiamethoxam and are registered for seed treatment uses must include the
following advisory statements:
• "Cover or collect treated seeds spilled during loading and planting in areas (such as in
row ends)."
• "Dispose of all excess treated seed by burying seed away from bodies of water."
• "Do not contaminate bodies of water when disposing of planting equipment wash water."
The purpose of these required advisory statements is to encourage the adoption of best
management practices when handling and planting clothianidin- and/or thiamethoxam-treated
seeds that will reduce the exposure of birds and mammals to treated seeds. Covering or
collecting spilled seed and burying excess seed are measures that will reduce the likelihood that
animals will find and consume treated seeds. Water bodies tend to be gathering points for birds
and mammals. Therefore, disposing of equipment wash-water away from these water bodies will
decrease the chance of contaminating these water bodies with neonicotinoid residues. Likewise,
disposing of excess seeds away from these water bodies will decrease the likelihood of animals
incidentally ingesting treated seeds while visiting a body of water. Finally, although these
advisory statements were developed with the primary intention of reducing the exposure of birds
and mammals to neonicotinoid-treated seed, adding these statements to labels is also expected to
benefit aquatic organisms by reducing neonicotinoid loading in aquatic systems.
9. Residential Ornamental Advisory
For application to ornamental plants, the agency identified significant risks of concern. In the
agency's final bee risk assessment, ornamentals are designated under the strongest evidence for
potential pollinator risk. Potential risks to aquatic invertebrates are also identified, with RQs
ranging up to 86. Clothianidin and thiamethoxam use on ornamentals is limited, with both
chemistries applied to approximately 3% of the crop acreage treated. However, other than the
available 2014 Aglnfomatics report and review, usage data is limited. To help mitigate these
risks, the agency is proposing the following advisory language for residential uses:
• "Intended for use by professional applicators."
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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.
10. Spray Drift Reduction 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 clothianidin and thiamethoxam
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
clothianidin or thiamethoxam.
The agency is proposing the following spray drift mitigation language be included on all
clothianidin and thiamethoxam 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 clothianidin and thiamethoxam registrants to standardize all
advisory language on clothianidin and thiamethoxam 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.
• 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.
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• 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 clothianidin and thiamethoxam that can enter waterbodies from runoff,
EPA is proposing a vegetative filter strip (VFS) requirement for all clothianidin and
thiamethoxam agricultural products of 10 feet. Currently some clothianidin and thiamethoxam
product labels already have a VFS requirement of 10 feet on labels. VFS are intended to reduce
sediment loads to adjacent water bodies, and also show some efficacy in reducing runoff volume
as well. As a consequence, they may have some utility in reducing movement of pesticides,
particularly those bound to sediments into natural waters.
They are somewhat expensive to implement and maintain, and they must be maintained, or they
will lose efficacy and channelized flow across the VFS will develop after a few years. VFS are
most effective at removing non-source point pollutants (e.g., pesticides) from runoff water
sources. However, the effectiveness of a VFS is influenced by various land management
practices (e.g., flood and furrow irrigated fields, etc.) which may impact their utility. The agency
has considered several additional sources of research which contextualize the benefits of VFS
and has determined that proposing the use of VFS is appropriate mitigation to reduce
clothianidin and thiamethoxam 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 clothianidin and
thiamethoxam. 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:
• 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
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states: WA, OR, CA, ID, NV, UT, AZ, MT, WY, CO, NM, and TX (west
of 1-3 5).
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 clothianidin and thiamethoxam 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 over-
spraying. 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 clothianidin and thiamethoxam 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 Spray Drift and Runoff Mitigation
Wind Speed, Boom Length/Swath Displacement, and Release Height
Current requirements for aerial applications are:
• Do not apply thiamethoxam when wind speeds exceed 10 mph at the application site. The
boom length must be 75% or less of the wingspan or rotor diameter.
• Do not apply clothianidin when wind speeds exceed 10 and 15 mph at the application site
(the label provides conflicting directions). The boom length must be 75% or less of the
wingspan and 90% of rotor diameter.
• The release height of both active ingredients 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 requirements for swath displacement on current labels.
There are no proposed changes for release height. Proposed changes will allow applications of
thiamethoxam 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
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complete an application, likely decreasing application costs. The proposed changes will provide
clarity to clothianidin users. To the extent that users make applications at wind speeds between
10 and 15 mph, boom lengths will be reduced under the proposal, which may necessitate more
passes to complete an application, potentially increasing application costs. Currently, there are
no requirements for swath displacement. The agency has not assessed the impacts of a '/2 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 thiamethoxam when wind speeds exceed 10 mph at the application site.
• The release height for thiamethoxam must be no higher than 10 feet from the top of the
crop canopy or ground (i.e., same as for aerial applications)
• Do not apply clothianidin when wind speeds exceed 15 mph at the application site.
• The release height for thiamethoxam must be no higher than 4 feet from the top of the
crop canopy or ground
Proposed changes will allow thiamethoxam applications at higher wind speed, which will
increase the flexibility growers have to make applications in a timely manner.
Proposed changes will allow applications of thiamethoxam 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
clothianidin or thiamethoxam.
Temperature Inversions (Ground and Aerial Applications)
Labels are currently silent on inversions or have advisory language to discourage applying
during inversions. The proposed requirement could result in delays to intended applications and,
more generally, reduce the amount of time users have to apply clothianidin and thiamethoxam.
Management of production activities will be more complex. Potentially, growers could switch to
a different active ingredient that does not have this restriction, but that would be costly and
potentially difficult in a short period of time. Moreover, temperature inversions are more likely
to occur a couple of hours before sunset and after sunrise, which is also when applications may
be timed to avoid spraying when pollinators are active, complicating growers' ability to follow
good stewardship programs.
Droplet Size
Currently, growers are advised to apply using medium or coarser droplets or the largest droplet
that provides effective control.
The agency is establishing a mandatory droplet size of medium or coarser for all neonicotinoids
to address the potential risks of neonicotinoids to terrestrial and aquatic invertebrates.
Components of applications, including droplet size, are complex, but essentially insects need to
come into contact with, or ingest, a lethal dose of insecticide to be effectively controlled which
requires proper coverage throughout the plant or foliage. Systemic insecticides, like clothianidin
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and thiamethoxam, control some insects regardless of droplet size due to the systemic movement
within the plant. However, neonicotinoids, including clothianidin and thiamethoxam, are
valuable because they also have immediate, contact activity, especially when applied to the
foliage.
Generally, entomologists accept that good coverage is required for maximum efficacy during an
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,
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
otherwise would, if allowed; make more frequent applications; and/or select alternative products.
These actions would likely increase pest control costs.
Requirements for Air Blast Sprayers
There are currently no specific requirements air blast applications. The agency does not
anticipate impacts to the users of clothianidin or thiamethoxam from requirements to direct spray
into the canopy and to turn off nozzles that would treat the outer orchard rows as this
corresponds to good application practices. The agency invites comments if this mitigation would
impact applicators.
Buffers and Vegetative Filter Strips
Currently, users of clothianidin and thiamethoxam are not to cultivate or plant crops within 25-
foot of aquatic areas to provide a VFS. The proposed requirement for would reduce the size of
the VFS to 10 feet or less for irrigated agriculture, but maintain the 25-foot area as a buffer.
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
thiamethoxam or clothianidin within the area previously part of the VFS due to the proposed
buffer.
However, the proposed 150-foot buffer from aquatic habitats for aerial applications represents a
substantial change that could impact usage of thiamethoxam and clothianidin. Currently, aerial
applications are used for nearly 30% of the area treated with clothianidin and almost 20% of the
area treated with thiamethoxam. Aerial applications are most common in soybean, in terms of
total acres and the proportion of acres treated by air, but aerial applications are relatively
common in some small acreage crops including lettuce, and brassica vegetables.22 Aerial
applications account for over 10% of the Florida orange acreage treated with clothianidin.
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.
22 Market Research Data. 2013-2017.
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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 are 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
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, clothianidin and thiamethoxam have
significant aerial applications to soybeans and cotton. The median size soybean field is 13.6
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 $116 per acre for the increase in lost cropped area from a buffer
change to 150 feet from 25 feet. The impacts are greater for smaller fields as is typical for
vegetable production. For example, ten percent of tomato fields are 2.2 acres or smaller and a
150-foot buffer for clothianidin and thiamethoxam could mean that almost 68% of the field could
be lost to a buffer if the field were adjacent to a water body.
The greatest impacts may be incurred by Florida orange growers who may be constrained from
making aerial applications of clothianidin for ACP control. Aerial applications may be part of
coordinated treatment programs among multiple growers. EPA encourages comments on the
impacts the buffer may have. Instead of taking land out of production, a grower could switch to a
different chemical that does not have a buffer requirement, apply an alternative to only those
areas of the field that is within the buffer or accept pest damage in the buffered areas. Leaving an
area untreated in a field can harbor insects and serve as a source of re-infestation, requiring
subsequent applications.
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, these
measures appear consistent with good application practices. The agency invites comments if this
mitigation would impact applicators.
11. 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
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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 clothianidin and thiamethoxam, 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/prn-2017-l-eiiidance-pesticide-reeistrants-
pesticide-resistance-management.
B. Stewardship
In addition to establishing both advisory and compulsory language for product labels, EPA's
registration review provides an opportunity to inform stakeholders and the general public about
opportunities to minimize potential ecological risks and promote pollinator health more
generally. Beyond the mitigation measures proposed above, voluntary stewardship activities and
use of best management practices (BMPs) can be effective in further reducing pesticide exposure
to at risk taxa. Examples of these activities include:
• promoting the creation of additional pollinator habitat;
• improving pesticide users' understanding and adherence to label directions which advise
users on seed spill clean-clean up, reduction in drift/runoff, and minimizing exposure to
pollinators;
• promoting integrated pest management (IPM) solutions;
• encouraging growers to take care when planting treated seed to reduce the amount of
exposed seed; and,
• increasing awareness of potential impacts of pesticides through education (e.g., training
courses, pamphlets, workshops/conferences, and through tv, radio, social media and other
communication platforms).
Habitat loss is a significant issue with negative impacts on the health of bees. With access to a
healthy and diverse diet through a thriving habitat, bees may be better able to tolerate stressors
such as pests, disease, and exposure to pesticides. As a healthy diet is crucial to maintaining
flourishing pollinator populations, and the protection of pollinator habitat is not something that
can be directly addressed on a pesticide product label, EPA and other federal/state/tribal and
local government agencies and non-government organizations (NGOs) promote pollinator
habitat through active education and outreach programs. Helpful guidance on pollinator
protection can be found on the EPA's pollinator protection webpage23.
Users should take several precautions while using neonicotinoid products to minimize potential
exposure to pollinators. First, users should not apply neonicotinoids when bees and other
pollinators are actively foraging on pollinator-attractive plants during bloom. Secondly, users
should consider a pesticide's ability to drift to other non-target areas and be aware of the
presence of bee colonies or highly bee-attractive plants nearby an application site. With
23 https://www.epa.gov/poHinator-protection
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applications to lawns, its beneficial to mow prior to applications, as this reduces the potential for
pollinator attractive weeds that could expose bees to pesticides. 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 webpage24.
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. The American
Seed Trade Organization has published a guide25 to help educate applicators on practices to help
reduce potential risks to the environment from seed treatments. The agency encourages public
and private participation in creating tools and fostering effective communication to help reach
applicators and educate them on practices that can reduce risks to the environment.
The technical registrants for the neonicotinoids, including Bayer, BASF, Mitsui, Syngenta, and
Valent, coordinated to develop a voluntary proposal to promote product stewardship for their
product seed treatments and applications in agricultural crops, production and landscape
ornamental plants, turfgrass and pest-management setting (structural, commercial and
residential). Their proposal includes a summary of the current neonicotinoid stewardship
program, as well as their proposal for an enhanced registrant-initiated stewardship program for
expansion and amplification of stewardship efforts. This document, Neonicotinoid Stewardship
Program - Current Summary and Proposal, is included in the public docket for each of the
neonicotinoids along with their PIDs.
The agency encourages strong pollinator protection stewardship in both the public and private
sector. EPA will continue to work with its partners at the federal, state, tribal, and local levels,
along with non-governmental organizations to promote pollinator protection, education, and
outreach. This includes coordinating with states and tribes on pollinator protection plans {i.e.;
managed pollinator protection plans), coordinating with stakeholders on extension of, and
education around, existing BMPs, and continued education and outreach to the public on
pollinator protection. In addition, the agency plans on continuing conversations with the
registrants on the Neonicotinoid Stewardship Program.
C. Tolerance Actions
Tolerance actions are proposed for clothianidin and thiamethoxam. The agency plans to modify
several established tolerances, mainly in response to revisions to the uses included in various
crop groups and subgroups. There are also opportunities for international harmonization with the
tolerances for clothianidin and thiamethoxam. Some listings are proposed to be harmonized with
Canadian MRLs and others with Codex MRLs. Additionally, EPA is proposing eliminating
24 https://www.epa.gov/poHinator-protection/what-YOii-can-do-protect-honeY-bees-and-other-poHinators
25 https://seed-treatinent-giiide.com/
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trailing zeros listed in tolerances consistent with agency policy. All proposed tolerance revisions
for clothianidin and thiamethoxam are listed in Section III.A.3 and Appendix E.
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), 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 clothianidin and thiamethoxam, nor is it making a complete
endangered species finding. Although the agency is not making a complete endangered species
finding at this time, the proposed mitigation described in this document is expected to reduce the
extent of environmental exposure and may reduce risk to listed species whose range and/or
critical habitat co-occur with the use of clothianidin and thiamethoxam. The agency's final
registration review decision for clothianidin and thiamethoxam 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
• Reference Standards:
o The analytical reference standard for clothianidin has expired and must be
submitted to the EPA's National Pesticide Standards Repository (see
https://www.epa.gov/pesticide-analvtical-methods/national-pesticide-standard-
repository).
o An analytical reference standard for thiamethoxam is available at the EPA's
National Pesticide Standards Repository (see https://www.epa.gov/pesticide-
analytical-methods/national-pesticide-standard-repository). However, the agency
proposes to require analytical reference standards for thiamethoxam's metabolite
CGA-322704 to be submitted to National Pesticides Standards Repository. Note
that the current analytical reference standard for thiamethoxam will expire on
October 31, 2020.
V. NEXT STEPS AND TIMELINE
A. Proposed Interim Registration Review Decision
A Federal Register Notice will announce the availability of this PID for clothianidin and
thiamethoxam 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
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leads the agency to change its PID, the EPA may issue an interim registration review decision for
clothianidin and thiamethoxam. However, a final decision for clothianidin and thiamethoxam
may be issued without the agency having previously issued an interim decision. A final decision
on the clothianidin and thiamethoxam 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 clothianidin and thiamethoxam
registrants must submit amended labels that include the label changes described in Appendix B.
The revised labels and registration amendments must be submitted to the agency for review
within 60 days following issuance of the Interim Registration Review Decision in the
clothianidin and thiamethoxam dockets.
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Appendix A: Summary of Proposed Actions for Clothianidin and Thiamethoxam
Table 1: Summary of Proposed Actions for Clothianidin
Registration Review Case#: 7620
PC Code: 044309
Chemical Type: insecticide
Chemical Family: nitroguanidine-substituted neonicotinoid
[Mode or Mechanism (for herbicides)] of Action: Nicotinic acetylcholine receptor (NACHR) competitive modulators
Affected Population(s)
Source of Exposure
Route of Exposure
Duration of
Exposure
Potential Risk(s) of
Concern
Proposed Actions
Occupational Handlers
Aerial and ground
application, treated
seeds
Dermal and inhalation
Short and
intermediate
term
Systemic effects
• Require additional PPE (e.g.,
gloves and respirators)
• Precautionary statements
• Use Restrictions
Pollinators
Residues on treated
Ingestion and contact
Acute and
Acute and chronic
• Reduce application rates
site
chronic
toxicity
• Crop stage restrictions
• Use deletions
• Use restrictions
• Buffers
• Spray drift reduction
Aquatic Invertebrates
Runoff from treated
Contact and ingestion
Acute and
Acute and chronic
• Spray drift reduction
sites
chronic
toxicity
• Prevent runoff
• Vegetative filter strips
• Reduce perimeter treatment
applications
Birds and Mammals
Residues on
ingested seeds
Dietary and ingestion
Acute and
chronic
Acute and chronic
toxicity
• Clean up spills of treated seeds
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Table 2: Summary of Proposed Actions for Thiamethoxam
Registration Review Case#: 7614
PC Code: 060109
Chemical Type: insecticide
Chemical Family: nitroguanidine-substituted neonicotinoid
[Mode or Mechanism (for herbicides)] of Action: Nicotinic acetylcholine receptor (NACHR) competitive modulators
Affected Population(s)
Source of Exposure
Route of Exposure
Duration of
Exposure
Potential Risk(s) of
Concern
Proposed Actions
Occupational Handlers
Aerial and ground
application
Dermal and inhalation
Short and
intermediate
term
Systemic effects
• Require additional PPE (gloves
and respirators)
• Precautionary statements
• Require closed loading for seed
treatment
• Cancel equipment/application
uses
Pollinators
Residues on treated
site
Ingestion and contact
Acute and
chronic
Acute and chronic
toxicity
• Reduce application rates
• Bloom restrictions
• Use deletions
• Use restrictions
• Buffers
• Spray drift reduction
Aquatic Invertebrates
Runoff from treated
sites
Contact and ingestion
Acute and
chronic
Acute and chronic
toxicity
• Spray drift reduction
• Prevent runoff
• Vegetative filter strips
• Reduce perimeter treatment
applications
Birds and Mammals
Residues on
ingested seeds
Dietary and ingestion
Acute and
chronic
Acute and chronic
toxicity
• Clean up spills of treated seeds
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Appendix B: Proposed Labeling Changes for Clothianidin and Thiamethoxam Products
Table 1: Proposed Labeling Changes for Clothianidin Products
Description
Proposed Label Language for Clothianidin Products
Placement on
Label
IVihnii-.il I'riiilik lo
For any product that allows
use on bulb vegetables
Delete foliar and soil use on bulbs.
Directions for Use
KihI I si1 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.
4A
CLOTHIANIDIN
GROUP
INSECTICIDE
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.
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 inEPA's chemical-resistance category
selection chart and list the appropriate chemical-resistant glove types to use.
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves
and a respirator) for seed
treatments to corn
"Handlers must wear chemical resistant gloves and a respirator while handling (e.g., loading,
applying, sewing, bagging, etc.) treated corn seeds."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves
and a respirator) for liquid
aerosol application to
commercial buildings
"Applicators must wear chemical resistant gloves and a respirator while treating commercial
buildings with liquid aerosol formulations."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves)
for liquid/foliar application
to barn/feedlot applied via
mechanically-pressurized
handgun
"Applicators and handlers must wear chemical resistant gloves while mixing, loading, or
applying liquid foliar formulations for a mechanically-pressurized handgun for livestock houses
(Note: This does not include poultry houses. Only non-poultry livestock houses (i.e.,
barns/feedlots))."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Requirements for
Non-WPS Uses,
including the use of
any products requiring
respirators for in-field,
seed, or post-harvest
treatments.
Respirator fit testing, medical qualification, and training
Using a program that conforms to OSHA's requirements (see 29 CFR Part
1910.134), employers must verily that any handler who uses a respirator is:
• Fit-tested and fit-checked,
• Trained, and
• Examined by a qualified medical practitioner to ensure physical ability to safely wear the style
of respirator to be worn. A qualified medical
practitioner is a physician or other licensed health care professional who
will evaluate the ability of a worker to wear a respirator. The initial
evaluation consists of a questionnaire that asks about medical conditions
(such as a heart condition) that would be problematic for respirator use. If
concerns are identified, then additional evaluations, such as a physical
exam, might be necessary. The initial evaluation must be done before
respirator use begins. Handlers must be reexamined by a qualified
medical practitioner if their health status or respirator style or use conditions change. Upon
request by local/state/federal/tribal enforcement personnel, employers must provide
documentation demonstrating how they have complied with these requirements.
Precautionary
Statements under the
heading "Hazards to
Humans and
Domestic Animals"
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
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.
Directions for Use for
mixing/loading WSP
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
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
verily 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
Directions for Use
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
pollination services must be notified no less than 48 hours prior to the time of the planned
application so that the bees can be removed, covered or otherwise protected prior to spraying."
For foliar spray application to crops not under contract pollinator services:
"Do not apply this product while bees are foraging. Do not apply this product until flowering is
complete and all petals have fallen off unless the application is made in response to a public
health emergency declared by appropriate State or Federal authorities."
All outdoor foliar spray
uses
"Do not apply by ground within 25 feet, or by air within 150 feet of lakes, reservoirs, rivers,
permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds."
Directions for use
Resistance-management
labeling statements for
insecticides and acaricides
Include resistance management label language for insecticides/acaricides from PRN 2017-1
(httDs://www.eDa.20v/Desticide-re2istration/Desticide-registration-notices-vear).
Directions for Use,
prior to directions for
specific crops
Additional Required
Labeling Action
Applies to all products
delivered via liquid spray
applications
Remove information about volumetric mean diameter from all labels where such information
currently appears.
Directions for Use
Berries and small fruit,
excluding grape and
strawberry, set maximum
annual rate
Maximum annual application rate for berries, regardless of application method, is not to exceed
0.16 lbs. a.i./A per year.
Directions for Use
Cotton, set maximum
annual rate
Regardless of application method, apply no more than 0.15 lbs. a.i./A per year, including seed
treatment, soil drench and foliar sprays.
Directions for Use
Fruiting Vegetables, set
maximum annual rate for
foliar spray
For foliar spray only: maximum annual application rate is not to exceed 0.17 lbs. a.i./A per year.
Directions for Use
Ornamentals, which
includes ornamental trees,
forestry, ornamental
woody shrubs and vines,
and outdoor
greenhouse/nursery. This
mitigation does not include
For both foliar spray and soil drench: maximum annual application rate is not to exceed 0.30 lbs.
a.i./A per year.
Directions for Use
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
indoor commercial
nursery, Christmas trees,
greenhouse uses, or
forestry use on public land
and quarantine application
by USD A.
Pome fruit, set maximum
annual rate for foliar spray
For foliar spray only: maximum annual application rate is not to exceed 0.16 lbs. a.i./A per year.
Directions for Use
Tree nuts, set maximum
annual rate for foliar spray
and soil drench
For foliar spray only: maximum annual application rate is not to exceed 0.16 lbs. a.i./A per year.
Soil drench: maximum annual application rate is not to exceed 0.38 lbs. a.i./A per year.
Directions for Use
Turf, set maximum annual
rate for foliar spray
For foliar spray only: maximum annual application rate is not to exceed 0.30 lbs. a.i./A per year.
Directions for Use
Avocado, banana, dates,
and olives, add application
timing restriction based on
crop stage
For foliar spray only: "Do not apply before bloom until after flowering is complete and all petals
have fallen off."
Directions for Use
Cucurbit, add application
timing restriction based on
crop stage
For foliar spray and soil drench: "Do not apply after vining or appearance of the first true (non-
cotyledon) leaf until harvest."
Directions for Use
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).
Only apply products containing clothianidin 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.
httDs://www.nrcs.iisda.eov/Internet/FSE DOCUMENTS/nrcsl44D2 030970.Ddf"
Directions for Use
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
Ornamentals, which
includes Ornamental
ground cover, Christmas
tree plantations,
Ornamental and/or shade
trees, ornamental
herbaceous plants,
ornamental nonflowering
plants, and ornamental
woody shrubs and vines
"Intended for use by professional applicators."
Directions for Use
Poultry houses set
maximum number of
applications and add
maximum application area
"Do not apply more than one whole house treatment and 5 perimeter (partial house) treatments
per year."
"Do not apply to more than 30,000 sq. ft. per year per house."
Directions for Use
Seed treatments, add to
seed bad tag
Add the following statements to tags to clean up spills, dispose of excess seed to avoid
contamination of water bodies:
"Cover or collect treated seeds spilled during loading and planting in areas (such as in row
ends)."
"Dispose of all excess treated seed by burying seed away from bodies of water."
"Do not contaminate bodies of water when disposing of planting equipment wash water."
Directions for use
All outdoor non-
agricultural spray
applications
"All outdoor spray applications must be limited to spot or crack-and-crevice treatments only,
except for the following permitted uses:
1. Application to soil, lawn, turf, and other vegetation;
2. Perimeter band treatments of 7 feet wide or less from the base of a man-made structure to
pervious surfaces (e.g., soil, mulch, or lawn)
3. Applications to the side of a man-made structure, up to 2 feet above ground level;
4. Applications to underside of eaves, soffits, doors, or windows permanently protected from
rainfall by a covering, overhang, awning, or other structure;
5. Applications around potential exterior pest entry points into man-made structures such as
doorways and windows, when limited to a band not to exceed one inch;
Directions for Use
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
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."
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
Outdoor non-agricultural
spray applications - rain
related statements (except
for products that require
watering-in)
"Do not make applications during rain. Avoid making applications when rainfall is expected
within 24 hours to allow product sufficient time to dry."
"Excessive rainfall within 24 hours after application may cause unintended run-off of pesticide
application."
Directions for Use
Outdoor non-agricultural
spot treatments
"Spot treatment is application to limited areas on which insects are likely to occur, but which
will not be in contact with food or utensils and will not ordinarily be contacted by workers.
These areas may occur on floors, walls, and bases or undersides of equipment. Spot treatments
must not exceed two square feet in size (2ft. by 1 ft.), not to exceed 10 % of the entire treatment
area"
Directions for Use
Spray Drift Management
Application Restrictions
for all products delivered
via liquid spray application
and allow aerial
application
"MANDATORY SPRAY DRIFT MANAGEMENT
Aerial ADDlications:
• Do not release spray at a height greater than 10 ft above the ground or vegetative
canopy, unless a greater application height is necessary for pilot safety.
• Applicators are required to use a medium or coarser (ASABE S572.1) droplet size.
• Do not apply when wind speeds exceed 15 mph at the application site. If the windspeed
is greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed
wing aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom
length must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of
the rotor diameter for helicopters.
• For aerial applicators, if the windspeed is 10 miles per hour or less, applicators must use
Vi swath displacement upwind at the downwind edge of the field. When the windspeed
is between 11-15 miles per hour, applicators must use 3/i swath displacement upwind at
the downwind edge of the field.
• Do not apply during temperature inversions."
Directions for Use, in
a box titled
"Mandatory Spray
Drift" under the
heading "Aerial
Applications"
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
Spray Drift Management
Application Restrictions
for products that are
delivered via spray
applications and that allow
airblast applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Airblast annlications:
• 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
"Mandatory Spray
Drift" under the
heading "Airblast
Applications"
Spray Drift Management
Application Restrictions
for products that are
delivered via liquid spray
applications and allow
ground boom applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Ground Boom ADDlications:
• User must only apply with the release height recommended by the manufacturer, but no
more than 4 feet above the ground or crop canopy.
• Applicators are required to use a medium or coarser droplet size (ASABE S572.1).
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
• Do not apply during temperature inversions."
Directions for Use, in
a box titled
"Mandatory Spray
Drift" under the
heading "Ground
Boom Applications"
Spray Drift Management
Application Restrictions
for products that are
delivered via liquid spray
applications and that allow
boom-less ground sprayer
applications
"MANDATORY SPRAY DRIFT MANAGEMENT
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
"Mandatory Spray
Drift" under the
heading "Boomless
Applications"
Advisory Spray Drift
Management Language for
all products delivered via
liquid spray application
"SPRAY DRIFT ADVISORIES
THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT.
BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL CONDITIONS.
IMPORTANCE OF DROPLET SIZE
An effective way to reduce spray drift is to apply large droplets. Use the largest droplets that
provide target pest control. While applying larger droplets will reduce spray drift, the potential
for drift will be greater if applications are made improperly or under unfavorable environmental
conditions.
Controlling Droplet Size - Ground Boom (note to registrants: remove if ground boom is
prohibited on product labels)
Directions for Use,
just below the Spray
Drift box, under the
heading "Spray Drift
Advisories"
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r
Description
• 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
Shielding the boom or individual nozzles can reduce spray drift. Consider using shielded
sprayers. Verify that the shields are not interfering with the uniform deposition of the spray on
the target area.
TEMPERATURE AND HUMIDITY
When making applications in hot and dry conditions, use larger droplets to reduce effects of
evaporation.
TEMPERATURE INVERSIONS
Drift potential is high during a temperature inversion. Temperature inversions are characterized
by increasing temperature with altitude and are common on nights with limited cloud cover and
light to no wind. The presence of an inversion can be indicated by ground fog or by the
movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and
moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion,
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Description
Proposed Label Language Cor C'lotliianidin Products
Placement on
Label
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
Boomless 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"
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Table 2: Proposed Labeling Changes for Thiamethoxam Products
Description
Proposed Label Language for Tliianicllioxani Products
Placement on
label J
l iul I sc 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.
THIAMETHOXAM
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
Additional PPE (gloves
and a respirator) for
mixing/loading/applying
dry flowable formulations
for poultry houses and
warehouses
"Handlers and applicators must wear chemical resistant gloves and a respirator while mixing,
loading, or applying using a mechanically pressurized handgun."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves)
for mixing/loading liquids
for aerial applications to
barley, beans (dry),
"Handlers must wear chemical resistant gloves while mixing or loading."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
canola/rapeseed, corn
(field), cotton,
cowpea/blackeyed pea,
flax, garbanzos (including
chick peas), lentils, lupine
(grain), mustard, peas
(field), potato, rice,
sorghum, soybeans, sugar
beet, sunflower, tobacco,
triticale, and wheat
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves)
for
mixing/loading/applying
dry flowable formulations
with a manually-
pressurized handwand to
poultry/livestock house/
horse barn/feed lot, and
mounds/nests
"Handlers and applicators must wear chemical resistant gloves while mixing, loading, or
applying with a manually-pressurized handwand."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves)
for mixing
/loading/applying liquids
with a manually-
pressurized handwand to
mounds/nests
"Handlers and applicators must wear chemical resistant gloves while mixing, loading, or
applying with a manually-pressurized handwand."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Additional PPE (gloves)
for
mixing/loading/applying
dry flowable formulations
with a mechanically-
pressurized handgun to
landscaping,
trees/shrubs/bushes
"Handlers and applicators must wear chemical resistant gloves while mixing, loading, or
applying with a mechanically-pressurized handgun."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
Additional PPE (gloves)
for
mixing/loading/applying
crack and crevice
treatments with a
manually-pressurized
handwand to warehouses,
childcare
center/schools/institutions,
and residential living
spaces
"Handlers and applicators must wear chemical resistant gloves while mixing, loading, or
applying crack and crevice treatments with a manually-pressurized handwand."
In the Personal
Protective Equipment
(PPE) within the
Precautionary
Statements and
Agricultural Use
Requirements, if
applicable
Requirements for
Non-WPS Uses requiring
respirators
"Respirator fit testing, medical qualification, and training:
Using a program that conforms to OSHA's requirements (see 29 CFR Part
1910.134), employers must verify that any handler who uses a respirator is:
• Fit-tested and fit-checked,
• Trained, and
• Examined by a qualified medical practitioner to ensure physical ability to safely wear the style
of respirator to be worn. A qualified medical practitioner is a physician or other licensed health
care professional who will evaluate the ability of a worker to wear a respirator. The initial
evaluation consists of a questionnaire that asks about medical conditions (such as a heart
condition) that would be problematic for respirator use. If concerns are identified, then additional
evaluations, such as a physical exam, might be necessary. The initial evaluation must be done
before respirator use begins. Handlers must be reexamined by a qualified medical practitioner if
their health status or respirator style or use conditions change. Upon request by
local/state/federal/tribal enforcement personnel, employers must provide documentation
demonstrating how they have complied with these requirements."
Precautionary
Statements under the
heading "Hazards to
Humans and
Domestic Animals"
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.
Directions for Use for
mixing/loading WSP
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
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.
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.
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
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 application to crops under contract pollinator services:
"Do not apply this product while bees are foraging. Do not apply this product until flowering is
complete and all petals have fallen unless the following condition has been met. If an application
must be made when managed bees are at the treatment site, the beekeeper providing the
pollination services must be notified no less than 48 hours prior to the time of the planned
application so that the bees can be removed, covered or otherwise protected prior to spraying."
For foliar application to crops not under contract pollinator services:
"Do not apply this product while bees are foraging. Do not apply this product until flowering is
complete and all petals have fallen off unless the application is made in response to a public
health emergency declared by appropriate State or Federal authorities."
Directions for use
All outdoor foliar spray
uses
"Do not apply by ground within 25 feet, or by air within 150 feet of lakes, reservoirs, rivers,
permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds."
Directions for Use
Resistance-management
labeling statements for
insecticides and acaricides
Include resistance management label language for insecticides/acaricides from PRN 2017-1
dittos ://www.eDa.eov/Desticide-reeistration/Desticide-reeistration-notices-veari
Directions for Use,
prior to directions for
specific crops
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
Additional Required
Labeling Action
Applies to all products
delivered via liquid spray
applications
Remove information about volumetric mean diameter from all labels where such information
currently appears.
Directions for Use
Seed treatments to corn
"Must be applied by closed system seed treatment application processes in a commercial seed
treatment facility."
Directions for Use
Berries and small fruits,
not including grapes, set
maximum annual rate for
foliar spray and soil drench
uses
Foliar SDravs:
Bushberrv SubarouiP (including but not limited to hiehbush blueberry, eooseberrv. red currant.
Directions for Use
etc.): maximum annual amplication rate is not to exceed to 0.15 lbs. a.i./A ocr year.
Caneberrv Suberout) (including but not limited to blackberry, rasobcrrv. etc.): maximum annual
application rate is not to exceed 0.07 lbs. a.i./A per year.
Low Growine Berrv SubarouiP (includine but not limited to lowbush blueberry, strawberry.
cranberry, etc.): maximum annual amplication rate is not to exceed 0.15 lbs. a.i./A oer year.
Small Fruit Vine Climbine Suberout) (includins but not limited to may do d: excludine aranc.
fuzzy kiwi fruit and eooseberrv): maximum annual amplication rate is not to exceed 0.09 lbs.
a.i./A per year.
Soil Drench:
Bushberrv SubarouiP (includins but not limited to hiehbush blueberry, eooseberrv. red currant.
etc.): maximum annual amplication rate is not to exceed 0.15 lbs. a.i./A oer vear.
Low Growine Berrv Suberoiup (includine but not limited to lowbush blueberry, strawberry.
cranberry, etc.): maximum annual amplication rate is not to exceed 0.15 lbs. a.i./A oer vear.
Small Fruit Vine Climbine Suberoiup (includine but not limited to maviPOD: excludine eraoe.
fuzzy kiwi fruit and eooseberrv): maximum annual amplication rate is not to exceed 0.22 lbs.
a.i./A per year.
Cotton, set maximum
annual rate
Regardless of formulation or method of application, apply no more than 0.09 lbs. a.i./A per year,
including seed treatment, soil drench and foliar spray uses.
Directions for Use
Avocado, banana, dates,
and olives, add application
For foliar spray only: "Do not apply before bloom until after flowering is complete and all petals
have fallen off."
Directions for Use
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Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
timing restriction based on
crop stage
Cucurbit, add application
timing restriction based on
crop stage for foliar spray
uses
For foliar spray only: "Do not apply after vining or appearance of the first true (non-cotyledon)
leaf until harvest."
Directions for Use
Fruiting vegetables, set
maximum annual rate for
foliar spray, and add
application timing
restriction based on crop
stage
For foliar spray only: "Do not apply after the appearance of the initial flower buds until
flowering is complete and all petals have fallen off."
For soil drench only: "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
Pome fruit, add application
timing restriction for foliar
spray uses
For foliar spray only: "Do not apply from bud break (also known as "swollen bud stage" in pear,
or "silver-tip stage" in apple) until after flowering is complete and all petals have fallen off."
Directions for Use
Stone Fruit, add
application timing
restriction for foliar spray
uses
For foliar spray only: "Do not apply from bud break until after flowering is complete and all
petals have fallen off."
Directions for Use
Tree nut, add application
timing restriction for foliar
spray uses
For walnuts and pecans:
"Do not apply prior to bud break until after flowering is complete and all petals have fallen off."
For other tree nuts crops:
"Do not apply prior to bloom until after flowering is complete and all petals have fallen off."
Directions for Use
All agricultural foliar spray
uses
"VEGETATIVE FILTER STRIPS
Construct and maintain a vegetative filter strip, according to the width specified below, of grass
or other permanent vegetation between the field edge and nearby down gradient aquatic habitat
(such as, but not limited to, lakes; reservoirs; rivers; permanent streams; marshes or natural
ponds; estuaries; and commercial fish farm ponds).
Only apply products containing thiamethoxam 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.
Directions for Use
97
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
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.
fattDS://www.nrcs.usda.eov/Internet/FSE DOCUMENTS/nrcsl44D2 030970.Ddf"
Ornamentals, which
includes Ornamental
ground cover, Christmas
tree plantations,
Ornamental and/or shade
trees, ornamental
herbaceous plants,
ornamental nonflowering
plants, and ornamental
woody shrubs and vines
"Intended for use by professional applicators."
Directions for Use
All outdoor non-
agricultural spray
applications
"All outdoor spray applications must be limited to spot or crack-and-crevice treatments only,
except for the following permitted uses:
1. Application to soil, lawn, turf, and other vegetation;
2. Perimeter band treatments of 7 feet wide or less from the base of a man-made structure to
pervious surfaces (e.g., soil, mulch, or lawn)
3. Applications to the side of a man-made structure, up to 2 feet above ground level;
4. Applications to underside of eaves, soffits, doors, or windows permanently protected from
rainfall by a covering, overhang, awning, or other structure;
5. Applications around potential exterior pest entry points into man-made structures such as
doorways and windows, when limited to a band not to exceed one inch;
6. Applications to vertical surfaces directly above pervious surfaces such as bare soil, lawn, turf,
mulch or other vegetation, and not over a hard impervious surface (e.g., driveways, sidewalks),
Directions for Use
98
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
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."
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
Outdoor non-agricultural
spray applications - rain
related statements (except
for products that require
watering-in)
"Do not make applications during rain. Avoid making applications when rainfall is expected
within 24 hours to allow product sufficient time to dry."
"Excessive rainfall within 24 hours after application may cause unintended run-off of pesticide
application."
Directions for Use
Outdoor non-agricultural
spot treatments
"Spot treatment is application to limited areas on which insects are likely to occur, but which
will not be in contact with food or utensils and will not ordinarily be contacted by workers.
These areas may occur on floors, walls, and bases or undersides of equipment. Spot treatments
must not exceed two square feet in si/e (2ft. by 1 ft.), not to exceed 10 % of the entire
treatment area."
Directions for Use
Spray Drift Management
Application Restrictions
for all products delivered
via liquid spray application
and allow aerial
application
"MANDATORY SPRAY DRIFT MANAGEMENT
Aerial ADDlications:
• Do not release spray at a height greater than 10 ft above the ground or vegetative canopy,
unless a greater application height is necessary for pilot safety.
• Applicators are required to use a medium or coarser (ASABE S572.1) droplet size.
• Do not apply when wind speeds exceed 15 mph at the application site. If the windspeed is
greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing
aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length
must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor
diameter for helicopters.
• For aerial applicators, if the windspeed is 10 miles per hour or less, applicators must use Vi
swath displacement upwind at the downwind edge of the field. When the windspeed is
between 11-15 miles per hour, applicators must use 3/i swath displacement upwind at the
downwind edge of the field.
• Do not apply during temperature inversions."
Directions for Use, in
a box titled
"Mandatory Spray
Drift" under the
heading "Aerial
Applications"
Spray Drift Management
Application Restrictions
for products that are
delivered via liquid spray
applications and that allow
airblast applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Airblast annlications:
• Sprays must be directed into the canopy.
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
Directions for Use, in
a box titled
"Mandatory Spray
Drift" under the
heading "Airblast
Applications"
99
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
• User must turn off outward pointing nozzles at row ends and when spraying outer row.
• Do not apply during temperature inversions."
Spray Drift Management
Application Restrictions
for products that are
delivered via liquid spray
applications and that allow
ground boom applications
"MANDATORY SPRAY DRIFT MANAGEMENT
Ground Boom ADDlications:
• User must only apply with the release height recommended by the manufacturer, but no
more than 4 feet above the ground or crop canopy.
• Applicators are required to use a medium or coarser droplet size (ASABE S572.1).
• Do not apply when wind speeds exceed 15 miles per hour at the application site.
• Do not apply during temperature inversions."
Directions for Use, in
a box titled
"Mandatory Spray
Drift" under the
heading "Ground
Boom Applications"
Spray Drift Management
Application Restrictions
for products that are
delivered via liquid spray
applications and that allow
boom-less ground sprayer
applications
"MANDATORY SPRAY DRIFT MANAGEMENT
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
"Mandatory Spray
Drift" under the
heading "Boomless
Applications"
Advisory Spray Drift
Management Language for
all products delivered via
liquid spray application
"SPRAY DRIFT ADVISORIES
THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT.
BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL CONDITIONS.
IMPORTANCE OF DROPLET SIZE
An effective way to reduce spray drift is to apply large droplets. Use the largest droplets that
provide target pest control. While applying larger droplets will reduce spray drift, the potential
for drift will be greater if applications are made improperly or under unfavorable environmental
conditions.
Controlling Droplet Size - Ground Boom (note to registrants: remove if ground boom is
prohibited on product labels)
• Volume - Increasing the spray volume so that larger droplets are produced will reduce spray
drift. Use the highest practical spray volume for the application. If a greater spray volume is
needed, consider using a nozzle with a higher flow rate.
• Pressure - Use the lowest spray pressure recommended for the nozzle to produce the target
spray volume and droplet size.
• Spray Nozzle - Use a spray nozzle that is designed for the intended application. Consider using
nozzles designed to reduce drift.
Directions for Use,
just below the Spray
Drift box, under the
heading "Spray Drift
Advisories"
100
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
Controlling Droplet Size - Aircraft (note to registrants: remove if aerial application is
prohibited on product labels)
• Adjust Nozzles - Follow nozzle manufacturers' recommendations for setting up nozzles.
Generally, to reduce fine droplets, nozzles should be oriented parallel with the airflow in flight.
BOOM HEIGHT - Ground Boom (note to registrants: remove if ground boom is prohibited
on product labels)
For ground equipment, the boom should remain level with the crop and have minimal bounce.
RELEASE HEIGHT - Aircraft (note to registrants: remove if aerial application is prohibited
on product labels)
Higher release heights increase the potential for spray drift.
SHIELDED SPRAYERS
Shielding the boom or individual nozzles can reduce spray drift. Consider using shielded
sprayers. Verify that the shields are not interfering with the uniform deposition of the spray on
the target area.
TEMPERATURE AND HUMIDITY
When making applications in hot and dry conditions, use larger droplets to reduce effects of
evaporation.
TEMPERATURE INVERSIONS
Drift potential is high during a temperature inversion. Temperature inversions are characterized
by increasing temperature with altitude and are common on nights with limited cloud cover and
light to no wind. The presence of an inversion can be indicated by ground fog or by the
movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and
moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion,
while smoke that moves upward and rapidly dissipates indicates good vertical air mixing. Avoid
applications during temperature inversions.
WIND
Drift potential generally increases with wind speed. AVOID APPLICATIONS DURING
GUSTY WIND CONDITIONS.
Applicators need to be familiar with local wind patterns and terrain that could affect spray drift."
101
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Description
Proposed Label Language for Tliianiellioxani Products
Placement on
Label
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"
102
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
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 pesticides. 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 clothianidin and thiamethoxam
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 clothianidin or thiamethoxam. 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 clothianidin and thiamethoxam
as part of completing this registration review.
103
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
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
Clothianidin, 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), clothianidin and and thiamethoxam are 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, 2013,26 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. Neither clothianidin nor thiamethoxam are 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.27
26 See http://www.regutations.gov/#idoeumentDetait;D=EPA~HQ~OPPT~2009~0477~0074 for the final second list of
chemicals.
27 https://www.epa.gov/endocrine-dismption
104
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
In this PID, the EPA is making no human health or environmental safety findings associated with
the EDSP screening of clothianidin and thiamethoxam. Before completing this registration
review, the agency will make an EDSP FFDCA § 408(p) determination.
105
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Appendix E: Summary of Proposed Tolerance Actions
Table 1: Clothianidin
/•'I. * I. ! .lik /--I'll *.•«!.
('l. Siimman of Proposed Tolerance Actions
Commodity
Currently
Kslablished
Tolerance (ppm)
lVoposed
Tolerance
(ppm)
Comments
(correct commodity definition) ¦
8180.586(a) General
Barley, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Barley, hay
None
0.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Barley, straw
None
0.3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Berry, low-growing, Subgroup
13-07H, except strawberry
0.01
0.07
Update to harmonize with Codex MRLs.
Brassica leafy greens
Subgroup 4-16B
None
1.9
Commodity displaced by crop group
conversion.
Celtuce
None
3
Commodity displaced by crop group
conversion.
Corn, field, forage
None
0.6
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, field, stover
None
0.3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, pop, stover
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, sweet, forage
None
0.7
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, sweet, stover
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Cotton, undelinted seed
0.20
0.2
Correct number of significant figures to be
consistent with EPA policy.
Florence fennel
None
3
Commodity displaced by crop group
conversion.
Fruit, pome
1.0
1
Correct number of significant figures to be
consistent with EPA policy.
Grain, cereal, forage, fodder
and straw, Group 16, except
rice, straw
0.05
0.2
Update to harmonize with Codex MRLs.
Grain, cereal, Group 15, except
rice
0.01
0.04
Update to harmonize with Codex MRLs.
Grape
0.60
0.6
Correct number of significant figures to be
consistent with EPA policy.
Kohlrabi
None
1.9
Commodity displaced by crop group
conversion.
106
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
( lothiiinidin 40 (T'R §1X0.5X6. Siimman of Proposed lolcriinci' Actions
Currently
Kstablished
Tolerance (ppm)
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition) ¦
Leafy greens Subgroup 4-16A
None
3
Commodity displaced by crop group
conversion.
Leafy petiole vegetable
Subgroup 22B
None
3
Commodity displaced by crop group
conversion.
Oat, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Peach
0.80
0.8
Correct number of significant figures to be
consistent with EPA policy.
Pepper
0.8
Remove
Change definition to:
Pepper/eggplant Subgroup 8-10B
Pepper/eggplant Subgroup 8-
10B
None
0.8
Commodity displaced by crop group
conversion.
Pomegranate
0.20
0.2
Correct number of significant figures to be
consistent with EPA policy.
Potato, chips
0.6
0.8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Potato, granules/flakes
1.5
2
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Rice, grain
None
0.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Rice, seed
0.01
Remove
Expired June 23, 2012.
Rye, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, forage
None
1
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, stover
None
0.8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Tomato Subgroup 8-10A
None
0.2
Commodity displaced by crop group
conversion.
Triticale, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Vegetable, brassica, leafy,
Group 5
1.9
Remove
Divide into separate listings:
Brassica leafy greens Subgroup 4-16B;
Vegetable, Brassica, head and stem, Group 5-
16; and Kohlrabi.
Vegetable, fruiting, Group 8,
except pepper
0.2
Remove
Divide into separate listings:
Tomato Subgroup 8-1 OA;
Pepper/eggplant Subgroup 8-10B.
107
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
( lothiiinidin 40 (T'R §1X0.5X6. Siimman of Proposed Tolcnincc Actions
i hireiiih
1 MaNklieil
1 ''leiaiice i ppm '
Proposed
Tolerance
(ppm)
Comments
(correct commodity definition) ¦
Vegetable, head and stem
Brassica Group 5-16
None
1.9
Commodity displaced by crop group
conversion.
Vegetable, leafy, except
brassica, Group 4
3
Remove
Divide into separate listings:
Leafy green Subgroup 4-16A;
Correct number of significant figures to be
consistent with EPA policy.
Vegetable, tuberous and corm,
Subgroup 1C
0.3
0.4
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, forage
None
0.8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, grain
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, hay
None
1.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, straw
None
0.8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Table 2. Thiamethoxam
1 11ianielho\;iill 40 (T'R §IX0.5(o. Sumiliars of Proposed Tolcmncc Actions
1
C
CJ
l mi cull'.
Kslablished
1 ' l'' | ' "^L'l 1
1 •'lelaikv
¦ npii) i
(correct commodity definition) «
§180.5
65(a) General
Alfalfa, forage
0.05
10
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Alfalfa, hay
0.12
8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Alfalfa, seed
None
1
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Barley, grain
0.4
0.9
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Barley, hay
0.4
1.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Barley, straw
0.4
3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Brassica leafy greens Subgroup
4-16B
None
3
Update definition, and correct number of
significant figures to be consistent with
EPA policy.
108
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Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Thiaim-lhoxiim 40 (T'R §l80.5(o. Su miliars ol" Proposed Tok-raiKT Actions
Currently
Kslablislied
1'olcrancc (ppm)
Proposed
Tolerance
Comments
(correct commodity definition ) «
-
Brassica, head and stem,
Subgroup 5-A
4.5
Remove
Divide into separate listings:
Vegetable, Brassica, head and stem, Group
5-16; and
Kohlrabi.
Brassica, leafy greens,
Subgroup 5-B
3
Remove
See Brassica leafy greens Subgroup 4-
16B.
Caneberry Subgroup 13-07A
0.35
0.5
Update to harmonize with Codex MRLs.
Cattle meat byproducts
0.04
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Celtuce
None
4
Commodity displaced by group
conversion.
Corn, field, forage
0.1
0.7
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, field, stover
0.05
1
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, pop, forage
0.1
0.7
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, pop, stover
0.05
0.7
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, sweet, forage
0.1
5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Corn, sweet, stover
0.05
0.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Florence fennel
None
4
Commodity displaced by group
conversion.
Fruit, citrus, Group 10
0.4
Remove
See Fruit, citrus, Group 10-10.
Fruit, citrus, Group 10-10
None
0.4
Update definition.
Fruit, pome, Group 11
0.2
Remove
See Fruit, pome, Group 11-10.
Fruit, pome, Group 11-10
None
0.2
Update definition.
Fruit, stone, Group 12
0.5
Remove
See Fruit, stone, Group 12-12.
Fruit, stone, Group 12-12
None
0.5
Update definition.
Goat meat byproducts
0.04
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Horse meat byproducts
0.04
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Kohlrabi
None
4.5
Commodity displaced by group
conversion.
Leafy greens Subgroup 4-16A
None
4
Commodity displaced by group
conversion.
109
-------
Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Thiaim-lhoxiim 40 (T'R §l80.5(o. Su miliars ol" Proposed Tok-raiKT Actions
Currently
Kslablislied
1'olcrancc (ppm)
Proposed
Tolerance
Comments
(correct commodity definition ) «
-
Leafy petiole Subgroup 22B
None
4
Commodity displaced by group
conversion.
Milk
0.02
0.07
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Nut, tree, Group 14
0.02
Remove
See Nut, tree, Group 14-12.
Nut, tree, Group 14-12
None
0.02
Update definition.
Oat, grain
None
0.9
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Pistachio
0.02
Remove
See Nut, tree, Group 14-12.
Potato
None
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Rice, grain
None
6
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Rice, straw
None
2
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Rye, grain
None
0.9
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sheep meat byproducts
0.05
0.15
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, forage
0.02
0.9
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, grain
None
0.6
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, grain, stover
0.02
1.5
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sorghum, sweet, stalk
None
0.7
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Sugarcane
None
0.2
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Triticale, grain
None
0.3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Vegetable, fruiting, Group 8
0.25
Remove
See Vegetables, fruiting, Group 8-10
Vegetable, head and stem
Brassica Group 5-16
None
4.5
Commodity displaced by group
conversion.
110
-------
Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581
www.regulations.gov
Thiaim-lhoxiim 40 (T'R §l80.5(o. Su miliars ol" Proposed Tok-raiKT Actions
Currently
Kslablislied
1'olcrancc (ppm)
Proposed
Tolerance
Comments
(correct commodity definition ) «
-
Vegetable, leafy, except
brassica, Group 4
4.0
Remove
Divide into separate listings:
Leafy greens Subgroup 4-16A,
Leafy petiole vegetable Subgroup 22B,
Celtuce, and
Florence fennel
Vegetables, fruiting, Group 8-
10
None
0.25
Commodity displaced by group
conversion.
Wheat, bran
None
0.4
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, forage
0.5
3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, grain
None
0.3
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, hay
0.02
8
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
Wheat, straw
0.02
6
Based on new uses of thiamethoxam.
Recommended tolerance levels from HED,
30 January 2019, D446686.
111
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