Docket Number: EPA-HQ-OPP-2011-0865 

www.regulations.gov 

Clothianidin Summary Document 

 Registration Review: Initial Docket 

 December 2011 

 

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TABLE OF CONTENTS 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 11 

________________________________________ 

Please Note 

This Preliminary Work Plan (and Fact Sheet) summarizes the Environmental Protection 

Agency's current position on clothianidin based on the following documents: 

1. Registration Review: Problem Formulation for the Environmental Fate and Ecological 

Risk, Endangered Species, and Drinking Water Exposure Assessments of Clothianidin. 

December 13, 2011. 

2. Clothianidin. Human Health Risk Scoping Document in Support of Registration Review. 

December 8, 2011. 

3. Clothianidin: Review of Human Incidents. July 21, 2011. 

4. BEAD Chemical Profile for Registration Review: Clothianidin (044309). December 14, 

2011.

5. Screening Level Use Analysis (SLUA) for Clothianidin. April 18, 2011.

6. Appendix A for Clothianidin. June 23, 2011.

Supporting documents for clothianidin may be found in the docket (EPA-HQ-OPP-2011-0865) 

located on the internet at www.regulations.gov. 
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I. Preliminary Work Plan – Clothianidin 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides sold or distributed in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at: http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of clothianidin. 

Clothianidin is a broad-spectrum, systemic neonicotinoid insecticide registered for use to control 

chewing and sucking pests on a number of row and tree crops and turf. It is also registered for 

use in poultry houses and recreational and residential settings. Clothianidin induces paralysis 

and death in insects by enhancing nicotinic acetylcholine receptor activity. Clothianidin is a 

degradate of thiamethoxam that is also going through the registration review process (Case # 

7614). Products containing clothianidin were first registered in 2003 and, therefore, clothianidin 

was not subject to reregistration. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehensive ecological risk assessment, including an 

endangered species assessment, and a revised human health risk assessment for all uses of 

clothianidin. The following is a summary of the issues relevant to the registration review of 

clothianidin. 
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Ecological Risk: 

 The most recent ecological risk assessment for clothianidin was completed in 2010 in 

support of the registration of clothianidin for use as seed treatments on mustard and 

cotton. 

 The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for clothianidin. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether clothianidin’s use has “no 

effect” or “may affect” federally listed threatened or endangered species (listed species) 

or their designated critical habitats. When an assessment concludes that a pesticide’s use 

“may affect” a listed species or its designated critical habitat, the Agency will consult 

with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the 

Services), as appropriate. 

 On January 19, 2011, the Center for Biological Diversity and the Pesticide Action 

Network North America filed a lawsuit in the United States District Court for the 

Northern District of California, against the EPA for allegedly failing to undergo 

consultation with the United States Fish and Wildlife Service and the National Marine 

Fisheries Service regarding the effects of over 350 pesticides, including clothianidin, on 

over 200 endangered and threatened species throughout the United States (Center for 

Biological Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.).

 Previous risk assessments have assessed most major and minor degradates and the 

Agency concluded that they are expected to be as toxic or less toxic than parent 

clothianidin. Uncertainty regarding the clothianidin degradates thiazolylmethylguanidine 

(TMG) and N-(2-Chloro-5-thiazolylmethyl)-N’-nitroguanidine (TZNG) remain and the 

Agency anticipates requiring data on these degradates to support registration review. 

 The environmental fate and effects database is largely complete for clothianidin with the 

exception of effects data on avian and terrestrial invertebrate species. 

 Based upon the use pattern and the current available database on clothianidin, the Agency 

anticipates requiring the following ecological effects data for use in conducting a 

complete ecological risk assessment, including an endangered species assessment. 

GLN 850.2100 Acute avian oral toxicity for passerines 

GLN 850.3030 Honey bee toxicity of residues on foliage (TEP) 

GLN 850.3040 Field testing for pollinators (TEP) 

GLN 835.6200 Aquatic field dissipation (In Review) 
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Non-Guideline Pollinator larval toxicity 

Non-Guideline Laboratory pollinator feeding study 

Non-Guideline Residues in pollen and nectar/field residue analysis 

study 

Non-Guideline Chronic sediment toxicity test with midge larvae (with 

TGAI and the degradates TZNG and TMG) 

Non-Guideline Poultry litter residue study 

 The Agency is interested in receiving information or data that characterizes the potential 

exposure that may result from drift associated with pesticide products containing 

clothianidin. This should include information on non-traditional routes of exposure (e.g. 

dust drift from seed treatment planting operations. The Agency is also interested in 

receiving information or data on drift reducing technologies or other practices that reduce 

potential drift from both spray applications and seed treatments of clothianidin. 

 In an attempt to address protection of pollinators and other beneficial insects, EPA is 

anticipating requiring data to assess bees as a representative for all beneficial insects. In 

moving forward with addressing potential risk to these organisms, EPA will consider the 

recommendations of the Society of Environmental Toxicology and Chemistry (SETAC) 

Workshop on Pesticide Risk Assessment for Pollinators, and is working with its federal 

and state partners, industry, and academia to determine appropriate assessment 

methodology. For compounds, such as clothianidin, which (1) show acute toxicity to 

bees and (2) have exposure routes for bees, EPA anticipates requiring toxicity and 

exposure studies to allow for evaluation of risks to pollinators. The registrant should 

consult with EPA on the conduct of these studies. 

 Please refer to the document, Registration Review: Problem Formulation for the 

Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water 

Exposure Assessments of Clothianidin, dated December 13, 2011, located in the docket 

for a detailed discussion of the anticipated risk assessment and data needs. 

Human Health Risk:

 The most recent comprehensive human health risk assessment for clothianidin was 

completed in 2009 to support new use registrations on berries, Brassica vegetables, 

cotton, cucurbits, fig, fruiting vegetables, leafy vegetables, peach, pomegranate, soybean, 

tree nuts, and tuberous and corm vegetables. 

 The human health toxicity database is largely complete. The Agency anticipates 

requiring the following data for use in the registration review of clothianidin: 

GLN 870.3465 90 day inhalation toxicity 
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GLN 875.2100 Turf transferable residue study 

Special Study Residue chemistry comparisons of different 

formulations on select commodities 

 Side-by-side trials comparing residues from the WDG 

and SC formulations for leafy vegetables, Brassica

vegetables, non-bell peppers. Furthermore, HED 

determined that side-by-side trials were needed to 

demonstrate the effect of spray mix adjuvants on residue 

levels. 

 Side-by-side trials comparing residues from foliar and 

soil applications to leaf lettuce, mustard greens, peppers, 

and cucumbers.

 For the human health risk assessment, the residue of concern for the dietary assessment 

(i.e., drinking water) is parent clothianidin. The Agency anticipates updating the dietary 

risk assessment for clothianidin to incorporate any changes in policy. 

 The Agency anticipates conducting a new residential exposure assessment to incorporate 

changes in policy and to incorporate new data from the turf transferable residue study that 

is expected to be required. 

 The Agency anticipates calculating new aggregate risk estimates during this registration 

review if residential exposure estimates are revised. 

 In addition to the dermal and oral hand-to-mouth residential exposure assessments, 

residential bystander inhalation exposures resulting from off-site transport (e.g., spray 

drift or volatilization) may occur as a result of applications of clothianidin. The Agency 

is in the process of examining its policies and processes regarding assessment of these 

types of residential exposures. Therefore, the potential need for a bystander inhalation 

risk assessment for clothianidin will be examined during registration review. 

 The Agency anticipates updating the occupational handler and post application risk 

assessment, especially for seed treatment uses, to incorporate changes in policy and new 

agricultural transfer coefficients. 

 The tolerance expression for clothianidin will be reviewed during registration review to 

ensure that it appropriately covers the metabolites and degradates of clothianidin and that 

it specifies the residues to be measured for each commodity. 

 The Agency will modify tolerance levels as needed, and work to harmonize 

tolerances/maximum residue limits (MRL), where possible, in key export markets during 

registration review. 
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 Please refer to the document, Clothianidin. Human Health Assessment Scoping document 

in Support of Registration Review, dated December 8, 2011, located in the docket for a 

detailed discussion of the anticipated risk assessment and data needs for human health. 

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic 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, 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, 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 section 408(p), 

clothianidin is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

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 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 section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Clothianidin is 

not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for clothianidin. For further information 

on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the 

test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 
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Timeline:

EPA has created the following estimated timeline for the completion of the clothianidin 

registration review: 

Registration Review for clothianidin – Projected Registration Review Timeline

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period 2011 – December 

Close Public Comment 2012 – February 

Case Development 

Final Work Plan 2012 – May 

Issue DCI 2013 – Jan. – March 

Data Submission 2016 – Jan. – March 

Open Public Comment Period for Draft Risk Assessments 2017 – July – Sept. 

Close Public Comment Period 2017 – Oct. – Dec. 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

 2018 – Jan. – March 

Close Public Comment Period 2018 – April – June 

Registration Review Decision and Begin Post-Decision Follow-up 2018 

Total (years) 7 

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for clothianidin. 

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

Clothianidin is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act1. No Total Maximum Daily Load (TMDL) criteria 

have been developed for clothianidin2. More information on impaired water bodies and TMDLs 

 

1

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 2

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES 
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can be found at the Agency’s website3

. The Agency invites submission of water quality data for 

this pesticide. To the extent possible, data should conform to the quality standards in Appendix 

A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other

Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process4

 in 

order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to clothianidin, compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population. 

Other Information:

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining the ecological and human health risk assessments, including any speciesspecific effects determinations. The Agency is interested in receiving the following information: 

1. suggestions from stakeholders on ways to reduce non-target organism exposures to 

clothianidin 

2. confirmation on the following label information 

a. maximum application rates 

b. geographic limitations on use 

c. label language that specifies the method of incorporation to seed 

3. use or potential use distribution (e.g., acreage and geographical distribution of 

relevant crop) 

4. use history 

5. median and 90th percentile reported use rates (lbs. a.i./acre) from usage data – 

national, state, and county 

6. application timing (date of first application and application intervals) by crop – 

national, state and municipality 

7. sub-municipality crop location data 

8. directly acquired municipality-level usage data (not derived from state level data) 

a. maximum reported use rate (lbs. a.i./acre) from usage data – county 

b. percent crop treated – county 

c. median and 90th percentile number of applications – county 

d. total pounds per year – county 

e. the year the pesticide was last used in the county/sub-county area 

 

3

http://www.epa.gov/owow/tmdl/

4

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm 
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f. the years in which the pesticide was applied in the county/sub-county area 

9. state or local use restrictions 

10. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency 

11. monitoring data 

12. seasonal application rate limits and reapplication intervals for some labeled uses 

13. usage data associated with clothianidin use on ornamental plants and turf. Requested 

usage data should include use site, application rate on a per acre basis, application 

method, timing of application, acres/area treated, and registered alternative 

insecticides 

14. data that characterizes the potential exposure that may result from dust associated 

with seed treatment products 

15. data or information that characterizes either practices or technology that reduces 

potential exposure from spray drift or “dust off” from seed treated with clothianidin 

16. data or information on resistance to clothianidin 

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner, and then issue its Final Work Plan (FWP) for the registration 

review of clothianidin.
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II. FACT SHEET 

Background Information:

 Clothianidin PC Code: 044309, CAS#: 210880-92-5 

 Technical registrant: Valent USA Corporation (EPA Company Number 59639) 

 First registered in 2003 and therefore was not subject to reregistration. 

 There are 29 active FIFRA section 3 registrations (technical and end use) and 2 (special 

local need) section 24(c) registrations. 

 Tolerances for residues of clothianidin in or on a number of vegetables, fruits, and nuts 

and livestock feed and food commodities are codified in 40 CFR § 180.586. 

 Pesticide Re-evaluation Division Chemical Review Manager (CRM): Russell Wasem, 

wasem.russell@epa.gov

 Registration Division Product Manager (PM): Venus Eagle, eagle.venus@epa.gov 

Use & Usage Information: (For additional details, please refer to the BEAD Chemical Profile 

for Registration Review: Clothianidin, dated December 14, 2011, and Appendix A document, 

dated June 23, 2011, in the clothianidin docket.) 

 Clothianidin is a broad-spectrum, systemic neonicotinoid insecticide registered for use to 

control chewing and sucking pests on various food sites including pome fruits, stone 

fruits, citrus fruits, fruiting vegetables, cucurbit vegetables, cranberries, artichokes, and 

leafy vegetables, in poultry houses, and on turf. 

 Major usage of clothianidin is on corn with 700,000 lbs active ingredient applied 

annually. 

 Clothianidin is formulated as an emulsifiable concentrate, ready-to-use solution, flowable 

concentrate, soluble concentrate, dust, water-dispersible granule, and granule. 

 Clothianidin is applied foliarly, through soil drench, tree trunk injection, and seed 

treatments. 

Recent Actions:

 There are three pending new use registrations for clothianidin use as a seed treatment on 

leafy green vegetables and rice and as a foliar treatment for rice. 

 In 2011, new uses were registered for mustard and cotton seed treatments and as a trunk 

spray on ornamental trees. 

 In 2010, clothianidin was registered for use on berries, Brassica vegetables, cotton, 

cucurbit vegetables, fig, fruiting vegetables, leafy green vegetables, peach, pomegranate, 

soybean, tree nuts, and tuberous and corm vegetables. 
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Ecological Risk Assessment Status:

The following are key findings of the most recent clothianidin ecological risk assessment. Please 

refer to the Registration Review: Problem Formulation for the Environmental Fate and 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments of 

Clothianidin, dated December 13, 2011, for additional details. 

 The most recent comprehensive ecological risk assessment for clothianidin was 

completed in 2010 in support of the registration of clothianidin as a seed treatment for 

mustard and cotton. 

 The Agency concluded that risks exceeded the level of concern (LOC) for freshwater 

invertebrates, estuarine/marine invertebrates, birds, and mammals. Although the Agency 

did not quantitatively assess risk for non-target terrestrial invertebrates in the 2010 

assessment, information from standard tests, field studies, and incident reports suggest 

the potential for long-term toxic risks to honey bees and other beneficial insects. 

Human Health Risk Assessment Status:

The following are key findings of the most recent clothianidin human health risk assessment. 

Please refer to the Clothianidin. Human Health Assessment Scoping Document in Support of 

Registration Review, dated December 8, 2011, for additional detail. 

Hazard Characterization: 

 The most recent human health risk assessment for clothianidin was completed in 2009 

when clothianidin was registered for use on berries, Brassica vegetables, cotton, cucurbit 

vegetables, fig, fruiting vegetables, leafy green vegetables, peach, pomegranate, soybean, 

tree nuts, and tuberous and corm vegetables. Clothianidin causes decreased body weight 

gain, delayed sexual maturation and decreased thymus weights. 

 The Agency classified clothianidin as not likely to be carcinogenic to humans and 

determined that clothianidin is not mutagenic. 

Dietary (Food and Drinking Water): 

 The Agency concluded that dietary risk estimates were below the Agency’s level of 

concern for all durations and population subgroups. 

Residential: 

 EPA concluded that residential risk estimates were below the Agency’s level of concern 

for all scenarios and all population subgroups. 
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Aggregate: 

 Aggregate risk estimates (combined exposure from food, drinking water, and residential 

uses) were also below the Agency’s level of concern for all population subgroups. 

Occupational: 

 Occupational handler and post-application exposure risks for all applicable scenarios, 

were below the Agency’s level of concern with a single layer of clothing or with the 

addition of personal protective equipment or engineering controls. 

Human Studies: 

 Past clothianidin risk assessments rely in part on data from studies in which adult human 

subjects were intentionally exposed to a pesticide to determine their dermal and 

inhalation exposure. Many such studies, involving exposure to many different pesticides, 

comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure 

Database (PHED) and the Agricultural Reentry Task Force (ARTF) Database. EPA has 

reviewed all the studies supporting these multi-pesticide generic exposure databases, and 

has found no clear and convincing evidence that the conduct of any of them was either 

fundamentally unethical or significantly deficient relative to the ethical standards 

prevailing at the time the research was conducted. All applicable requirements of EPA’s 

Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies. 

Cumulative

 The most sensitive toxicological effect in mammals differs across the neonicotinoids. 

There is currently no evidence to indicate that neonicotinoids share common mechanisms 

of toxicity, and EPA is not following a cumulative risk approach based on a common 

mechanism of toxicity for the neonicotinoids. The Agency does not have other data that 

indicate clothianidin shares a common mechanism of toxicity with other chemical 

substances. If, in the future, new information on clothianidin is available that could 

potentially impact a cumulative risk assessment and result in a risk of concern, the 

Agency will revisit the need for a cumulative risk assessment. 

Incidents: 

 The Office of Pesticide Programs Incident Data System (IDS) was reviewed for reports 

of clothianidin human incidents. From 2006 to 2011, there were 25 incidents involving 

products containing clothianidin—all incidents were minor or of moderate severity. The 

Agency will continue to monitor human health incidents for clothianidin. 

 A review of the Agency’s Ecological Incident Information System (EIIS) identified one 

ecological incident attributed to clothianidin. The incident occurred in 2008 in Germany 
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and involved approximately 11,000 honeybee colonies. A review of the Avian 

Monitoring Information System (AIMS), which is maintained by the American Bird 

Conservancy, did not identify any bird incidents associated with clothianidin. The 

Agency will continue to monitor ecological incidents for clothianidin. Other bee 

incidents were reported in aggregate format, however neither the legality of use or the 

probability that clothianidin caused these incidents has been determined. 

Status of Data Call-Ins (DCIs): 

 There have been no data call-in notices issued for clothianidin. 

Tolerances and International Harmonization: 

 Tolerances are established under 40 CFR 180.586 for residues that result from 

agricultural uses. Also, tolerances for inadvertent residues in/on animal feed and a 

temporary tolerance on rice (expires June 23, 2012) exist for clothianidin. 

 U.S. tolerances are harmonized with Canadian MRLs but differ, in many cases, from 

Codex MRLs. 

Labels: 

 The labels for clothianidin can be obtained from the Pesticide Product Label System 

(PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home.