UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON D.C., 20460 

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

September 28,2005 

PC Code 044309 

DP Barcodes: D313414, D314536 and D313415 

MEMORANDUM \ 

SUBJECT: EFED Registration Chapter for Clothianidin for use on Potatoes and Grapes as a 

spray treatment and as a Seed Treatment for Sorghum and Cotton. 

I FROM: N.E. Federoff, Wildlife Biologist/Team Le 

M. Barrett, Senior ScientistJWater Model 

Environmental Risk Branch V 

Environmental Fate and Effects Division (7507~) - 

THROUGH: Mah T. Shamim, Ph.D., Chief 

Environmental Risk Branch V 

Environmental Fate and Effects Di 

TO: C. Rodia, Risk Manager Reviewer 

D. Kenny, Risk Manager 01 

Registration Division (7505C) 

This memo summarizes the Environmental Fate and Effects Division's (EFED) screening-level I Environmental Risk Assessment for Clothianidin. The registrant, Arvesta Corporation, is 

submitting clothianidin to be used on potatoes, grapes and as a seed treatment for sorghum and 

cotton. 

Clothianidin's major risk concern is to nontarget insects (that is, honey bees). EFED expects 

adverse effects to bees if clothianidin is allowed to be sprayed on blooming, pollen-shedding, or 

nectar producing parts of plants. Because of this, EFED is recommending bee precautionary 

labeling prohibiting such clothianidin applications. 

Clothianidin is a neonicotinoid insecticide that is both persistent and systemic. Acute toxicity 

studies to honey bees show that clothianidin is highly toxic on both contact and oral basis. 

Although EFED does not conduct RQ based risk assessments on non target insects, information 

from standard tests and field studies, as well as incident reports involving other neonicotinoids 

insecticides (e.g., imidacloprid) suggest the potential for long term toxic risk to honey bees and 

other beneficial insects. Other neonicotinoid compounds like imidacloprid (e.g., sunflower seed 

Text Searchable Document
treatment) have resulted in incidents to honey bees. The product to be used for the proposed seed 

treatment for cotton is a mixture of clothianidin and imidacloprid. Since imidacloprid is 

systemic, and clothianidin appears to be also, there is a possibility of adverse effects to beneficial 

insects such as honey bees from products containing either compound. 

Based on proposed application rates and uses, acute and chronic risks to small birds and 

T mammals are unlikely, except for endangered mammals should exposure actually occur. In 

addition, considering the mode of agricultural practice of drilling seeds during planting, EFED , believes that clothianidin seed treatment should result in minimal acute risk to these organisms. 

A Tier I1 assessment for aquatic species (using the PRZMIEXAMS model) indicates that only the 

acute endangered species level of concern was exceeded for freshwater invertebrates (RQs 0.067 

to 0.086) for the potato use, implying a possible level of risk should exposure actually occur. 

Clothianidin does not appear to present risk to terrestrial plants (there were no significant effects 

in the studies submitted). In addition, it does not appear to present risk to aquatic vascular or 

nonvascular plants. 

The available environmental fate data for clothianidin indicates that the chemical is persistent, 

mobile, and systemic. It is stable to hydrolysis at all pHs at environmental temperatures, has the 

potential to leach to groundwater, be transported via runoff to surface water bodies, and could 

accumulate in soils from year to year with repeated uses. The major route of dissipation for 

clothianidin would appear to be photolysis if exposure to sunlight occurs (e.g., the measured 

aqueous photolysis half-life was <1 day and aerobic half-lives were 148 to 1155 days). Major 

degradates include TMG, MNG, and TZNG. 

Risk to Endangered Species 

Based on available information, clothianidin may be of concern to endangered freshwater aquatic 

invertebrates (both single and multiple application to potatoes) and some small (15g) mammal 

species (potato and grape uses), should exposure actually occur. A probit slope response 

relationship was evaluated to calculate the chance of an individual event corresponding to the 

listed species acute LOCs. Analysis of raw data from the mammalian and aquatic acute toxicity 

studies for clothianidin estimated a slope of 7.61 and 4.24 for mammals and freshwater 

invertebrates, respectively. Based on these slopes, the corresponding estimate chance of 

individual mortality following clothianidin exposure is only 1 in 7.21 x 1013 for small mammals 

and 1 in 5.76 x lo7 for freshwater invertebrates. Also, endangered beneficial insects may be at 

risk due to the toxicity profile for honeybees (clothianidin is toxic to honeybees, thus risk is 

assumed). 

EPA's Interim Policv for Potential Endocrine Disruptors 

EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by 

FQPA, to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) "may have an effect in humans that is similar to an effect 

produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator 
may designate." Following the recommendations of its Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for I including, as part of the program, the androgen- and thyroid hormone systems, in addition to the 

estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program 

include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA 

and, to the extent that effects in wildlife may help determine whether a substance may have an 

effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops 

and resources allow, screening of additional hormone systems may be added to the Endocrine 

Disruptor Screening Program (EDSP). When the appropriate screening and or testing protocols 

being considered under the Agency's Endocrine Disruptor Screening Program have been 

developed, clothianidin may be subjected to additional screening and or testing to better 

characterize effects related to endocrine disruption. 

Data suggests that clothianidin cpuld be a candidate for additional screening andlor testing to 

better characterize effects related to endocrine disruption. Effects in avian species included 

significant decreases in eggshell thickness. Effects in mammalian reproduction studies included 

decreased body weight gains and delayed sexual maturation (males only), decreased absolute 

thymus weight in F1 pups (both sexes), increased stillbirths (Fl and F2 litters), decreased sperm 

mobility and increased number of sperm with detatched heads (F1 and F2 litters). 

Outstanding Data Requirements 

Environmental Fate: 

162-4 Aerobic Aauatic metabolism Study. Based on the additional information submitted by the 

registrant, EFED agreed to change the previously-reviewed aerobic aquatic metabolism study 

(MRID 45422324) from "unacceptable" to "supplemental". However, the aerobic aquatic 

metabolism data requirements are still not fulfilled, the registrant must submit a new aerobic 

aquatic metabolism study. Reasons are presented below: 

1. The potential for clothianidin to move from the treated area to the nearby surface water body 

has been increased significantly since 2003 because the registrant has recently added new uses on 

the labels. According to the review completed on 2/20/2003 (Title - "EFED Risk Assessment 

for the Seed Treatment of Clothianidin 600FS on Corn and Canola", the Agency required the 

regilstrant to conduct a new aerobic aquatic metabolism study (162-4). This risk assessment was 

based on the maximum application rate for the seed treatment at 0.1 lb ai/A. However, according 

to the new uses reviewed by EFED (Turfgrass, Tobacco, Apples, Pears, and Ornamentals), this 

cheinical can be directly applied to the soil surface/foliage at much higher application rate (0.4 

lbs ai/A). As a result, the potential for clothianidin to move from the treated area to the nearby 

surface water body under the new uses is much greater than the use as a seed treatment. 

Therefore, there is a need for a better understanding of the fate of clothionidin in the aerobic 

aquatic environment. 

2. The fate of the thiazolyl ring was not monitored in the previously-reviewed aerobic aquatic 

metabolism study (MRID 45422324) because the test substance was labeled on the nitroimino 

side chain. Therefore, the fate of the thiazolyl ring remains unknown. The fate guidelines 
recommend to use the ring-labeled test substance. 

3. A well-designed new aerobic aquatic metabolism study is deemed critical for EPA to fully 

assess the risk of clothionidin in the aquatic environment. 

166-1 Small-Scale Pros~ective Groundwater Monitoring Study. Due to direct soil and foliar 

applications of clothianidin and concerns about the chemical leaching into ground water (see 

below), the Agency will request the registrant to submit a small-scale prospective groundwater 

monitoring study. 

Source: EPA review "EFBD Risk Assessment for the Seed Treatment of Clothianidin 

600FS on Corn and Canola" dated February 20,2003 (page 3): 

"Clothianidin has the properties of a chemical which could lead to widespread groundwater contamination, but no ground-water monitoring studies have been conducted to 

date. Should the registrant request field uses involving direct application of clothianidin 

to the land surface, Prospective Ground-Water Monitoring Studies may be needed to 

evaluate fully the potential impact of such uses." Due to the extreme mobility and 

persistence of clothianidin in the environment, a small-scale prospective groundwater 

monitoring study will provide additional fate information on the better understanding of 

this chemical in the environment and improve the certainty of the risk assessment. 

Ecological Effects: 

The database available for clothianidin to support the assessment was largely complete. EFBD 

received and reviewed a honey bee residue on foliage (141-2). EFED also received a honey bee 

field testing for pollinators (141-5) protocol from Bayer Cropscience's (BCS's) [Clothianidin 

(044309), D2953 181. The protocol title is: An Investigation of the Potential Long-Term Impact 

of Clothianidin Seed Treated Canola on Honey Bees, Apis mellifera L. The study was due in may 

2005 but the registrant has requested an extension. 

EFED and Canada's Pest Management Regulatory Agency (PMRA) completed a joint review of 

BCS's proposed field study at the end of March, 2004. EFED has not received any response 

from BCS since the completion of this joint review. The following ecological studies for 

clothianidin are still outstanding and need to be submitted. 

OPPTS 850.1735: Whole Sediment Acute Toxicity Invertebrates, Freshwater. This is a 28 

day test that measures survival, growth and emergence of Chironomus riparius that have been 

exposed to pesticide spiked sediment. EFED is requesting this acute sediment toxicity test 

because clothianidin is toxic to aquatic invertebrates, persistent in the environment, and binds to 

sediment over time. 

OPPTS 850.1740: Whole Sediment Acute Toxicity Invertebrates, Estuarine and Marine - 

Testing with estuarinelmarine invertebrates using the TGAI is required for clothianidin because 

clothianidin is toxic to aquatic invertebrates, persistent in the environment, binds to sediment 

over time. and the end-use product is expected to reach the marinelestuarine environment 
because of it use in coastal counties. 

Field Test for Pollinators (141-5): The possibility of toxic exposure to nontarget pollinators 

through the translocation of clothianidin residues that result from seed treatment (corn and 

canola) has prompted EFED to require field testing (141-5) that can evaluate the possible chronic 

exposure to honey bee larvae and queen. In order to fully evaluate the possibility of this toxic 

effect, a complete worker bee life cycle study (about 63 days) must be conducted, as well as an 

evaluation of exposure and effects to the queen. 

Seed Leaching Study: EFED believes that a seed leaching study would greatly increase certainty 

regarding a more realistic estimate of the amount of available clothianidin residues on the seed 

surface. This in turn would allow a refinement of exposure estimates and environmental 

concentration values (EECs). 

Uncertainties 

The uncertainties associated with clothianidin exposure in the environment are mainly focused in 

these areas; 1) accumulation of clothianidin in soils after repeated uses and the potential for 

transport/migration to surface water bodies and potential risk to sensitive aquatic invertebrates 

(e.g., sediment-dwelling benthic organisms); 2) repeated or continuous exposure of small 

mammals and birds to the pesticide presenting a potential reproduction and developmental risk; 

3) the possibility of toxic exposure to nontarget pollinators through the translocation of 

clothianidin residues to blooming, pollen-shedding or nectar-producing parts of plants that result 

from clothianidin's uses; and 4) repeated or continuous exposure to soil invertebrates and small 

mammals to clothianidin accumulated in soils after repeated uses. 

For terrestrial screening risk assessments, a generic bird or mammal is assumed to occupy either 

the treated field or adjacent areas receiving pesticide at a rate commensurate with the treatment 

rate on the field. The actual habitat requirements of any particular terrestrial species are not 

considered, and it is assumed that species exclusively and permanently occupy the treated area 

being modeled. This assumption leads to a maximum level of exposure in the risk assessment. 

In the absence of specific data, EFED assumes the most conservative scenario. Screening-level 

risk assessments for spray applications of pesticides usually consider dietary exposure alone. 

EFED Label Recormnendations 

Label Recormnendations 

Manufacturing Use Product 

Do not discharge effluent containing thii product into lakes, streams, ponds, estuaries, oceans, or 

other waters unless in accordance with the requirements of a National Pollutant Discharge 

Elimination System (NPDES) permit and the permitting authority has been notified in writing 

prior to discharge. Do not discharge effluent containing this product to sewer systems without 

previously notifying the local sewage treatment plant authority. For guidance contact your State 

Water Board or Regional Office of the EPA. 
End Use Products 

This product is toxic to aquatic invertebrates. Do not apply directly to water or to areas where 

surface water is present or to intertidal areas below the mean high-water mark. Do not 

contaminate water when cleaning equipment or disposing of equipment washwaters. Do not 

apply where runoff is likely to occur. Do not apply when weather conditions favor drift from 

treated areas. Drift and runoff from treated areas may be hazardous to aquatic organisms in 

neighboring areas. Apply this product only as specified on the label. 

This chemical has properties and characteristics associated with chemicals detected in ground 

water. The use of this chemical in areas where soils are permeable, particularly where the water 

table is shallow, may result in ground water contamination. 

This compound is toxic to birds and mammals. Treated clothianidin seeds exposed on soil 

surface may be hazardous to birds and mammals. Cover or collect clothianidin seeds spilled 

during loading. 

For products applied as a foliar spray, EFED recommends the following labeling statement: 

"This product is toxic to bees exposed to treatment and for more than 5 days following treatment. 

Do not apply this product to blooming, pollen-shedding or nectar-producing parts of plants if 

bees may forage on the plants during this time period, unless the application is made in response 

to a public health emergency declared by appropriate state or federal authorities." 

Label statements for spray drift management: 

Do not allow this product to drift onto neighboring crops or non crop areas or use in a manner or 

at a time other than in accordance with label directions because animal, plant or crop injury, 

illegal residues or other undesirable results may occur. 

AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS THE RESPONSIBILITY OF 

THE APPLICATOR. The interaction of many equipment-and-weather-related factors determine 

the potential for spray drift. The applicator is responsible for considering all these factors when 

making decisions. Where states have more stringent regulations, they should be observed. 
Data Requirement Tables 

161-1 Hydrolysis 454223 17 Core 

161-2 Photodegradation in 454223 18 

Water 454223 19 

45422320 

45422321 

45422322 

Core 

Supplemental 

Core 

Supplemental 

Core 

161-3 Photodegradation on Soil 45422323 Core 

161-4 Photodegradation in Air Waived 

162-1 Aerobic Soil Metabolism Core 

Core 

Supplemental 

Supplemental 

162-2 Anaerobic Soil 

Metabolism 

162-3 Anaerobic Aquatic 

Metabolism 

Core 

162-4 Aerobic Aquatic 

Metabolism 

Supplemental 

Supplemental 

Leaching- 454223 1 1 

Adsorption/Desorption 454223 12 

454223 13 

454223 14 

454223 15 

454223 16 

Laboratory Volatility NIA 

Core 

Ancillary 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Waived 

Field Volatility NIA NIA Waived 
Terrestrial Field 

Dissipation 

Aquatic Field Dissipation 

Accumulation in Fish 

Accumulation- aquatic 

non-target 

Ground Water- small 

prospective 

Droplet Size Spectrum 

Core 

Core 

Core 

Supplemental 

Core 

Core 

Core 

Core 

Core 

Supplemental 

Ancillary 

Ancillary 

Supplemental 

(upgradable) 

Reserved 

Waived 

ReservedYes 

Reserved 

202- 1 Drift Field Evaluation NIA Reserved 
Table of Ecological Tox~city Data Requirements 

Data Requirement MRID # Classification Is more data needed' 

Guideline # 

71-1 Avian acute oral LD, 

(mallard duck) 45422417 

(japanese quail) 45422418 

Core 

Supplemental 

71-2 Av~an subacute dietary LC,, 

(bobwhite quai)l 45422419 

(mallard duck) 45422420 

Core 

Core 

71-4 Avian reproduction 45422421 

(bobwhite quail) 45422422 

(mallard duck) 

Core 

Supplemental 

72-1 Freshwater fish acute LC,, 

(rainbow trout) 

TGAI 45422406 

DEG 45422408 

DEG 45422409 

DEG 45422410 

(bluegill sunfish) 45422407 

TGAI 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Core 

72-2 Freshwater invertebrate acute EC,, 

(daphnia) 

TGAI 

DEG 

DEG 

DEG 

Core 

Core 

Core 

Supplemental 

(chironomid) 

TGAI 45422414 Supplemental 

OPPTS Acute Freshwater Invertebrate Sediment . 850.1735 Toxicity 

TGAI not applicable not applicable Yes 

Estuarinelmarine fish acute LC,, 

(sheepshead minnow) 45422411 Supplemental 

Estuarinelmarine invertebrate acute EC,, 

(eastern oyster) 

45422404 Core 

(mysid) 

45422403 Core 

45422413 Supplemental 

Freshwater fish early life stage 

(fathead minnow) 

Freshwater invertebrate life cycle 

(daphnia) 45422412 Supplemental 

Estuarinelmarine life cycle 

(mysid) 45422405 Core 

Acute Freshwater Invertebrate Sediment 

Toxicity 

TGAI Yes 

No 

not applicable not applicable 

Aquatic Field Study NA 
Table of Ecological Toxicity Data Kcquiremenls 

Data Kequiremcnt MRlD # Classification Is more data needed? Guideline # 

81-1 Acute mammalian oral LD, 

(rat) 45422621 Core 

(mouse) 45422622 Core 

83-1 Mammalian Chronic 

(rat) 45422714-16 Core 

45422825 -26 No 

(rat) Core 

(rabbit) 454227 12- 13 Core 

122-l(a) Seedhng Emergence - Tier I 45422501 Core No 

122- 1 (b) Vegetative Vigor - Tier I 45422502 Core No 

122-2 Aquatic plant algae 

TGAI 45422504 Core 

DEG 45422505 Core Yes1 

DEG 45422506 Core 

DEG 45422507 Core 

123-2 Aquatic plant acute EC, 45422503 Core No 

141-1 - Acute honey bee contact LD,, 45422426 Core No 

Non-guideline Acute honey bee oral LD, 

TGAI 45422426 Supplemental 

DEG 45422427 Supplemental 

DEG 45422428 Supplemental No 

DEG 45422429 Supplemental 

DEG 45422430 Supplemental 

141-2 Honey Bee Residue on Foliage 45490702 Supplemental Yes 

141-5 Honey Bee Field Testing for Pollinators 45422431 

45422432 

45422433 

45422435 

45422436 

45422437 

45422440 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Supplemental 

Yes 

Non-guideline Earthworm Chronic 45422525 Supplemental 

45422526 Supplemental 

1 EFED needs 3 more Tier I or Tier II Core clothianidin studies for the nonvascular surrogate species, marine diatom (Skeletonema costatum), 

blue-green algae (Anabaena flos-aquae), and a freshwater diatom. 
Environmental Fate and Ecological Risk Assessment 

for the Registration of 

CLOTHIANIDIN for Use as a Spray on Potatoes and Grapes and also as 

a Seed Treatment for Sorghum and Cotton 

I . Executive Summary ............................................ Page L of 96 

II . Physical/Chemical Properties Characterization ....................... Page 4 of 96 

Pesticide Type. Class. Mode of Action ............................. Page 5 of 96 

III . Use Characterization ........................................... Page 5 of 96 

Currently Approved Crops ....................................... Page 5 of 96 

IV . Problem Formulation ........................................... Page 6 of 96 

Tier I Aquatic Assessment ....................................... Page 8 of 96 

Tier I Terrestrial Assessment ..................................... Page 9 of 96 

V . Analysis .................................................... Page lOof 96 

Environmental Fate Characterization .............................. Page f 0 of 96 

Aquatic Exposure Characterization ............................... Page 12 of 96 

Terrestrial Exposure Characterization ............................. Paee f 6 of 96 

VI . Risk Characterization .......................................... Page t 7 of 96 

Appendix I . FATE ................................................ Page 38 of 96 

Appendix 11 . Ecological Toxicity Data Summaries ....................... Page 52 of 96 

Appendix III . Bibliography ........................................... Page 68 of 96 

Appendix IV . Structures of Clothianidin and Degradation Products ........... Page 69 of 96 

Appendix V . Results of FATE Model .................................. Page 74 of 96 

Appendix VI: List of Listed EndangeredIThreatened Species ................. Page 76 of 96 

Appendix VII: PRZMIEXAMS output .................................. Page 81 of 96 
I. Executive Summary 

The registrant, Arvesta Corporation, is submitting clothianidin to be used on potatoes and grapes 

and also as a seed treatment on sorghum and cotton. This risk assessment primarily focuses on 

risk to honey bees from application of clothianidin. It also identifies any possible risk to small 

birds and mammals which may be exposed to residual clothianidin from spray and seed 

application methods. No risk was found for birds, mammals or aquatic species from either spray 

or seed treatment applications. The endangered species acute LOC for 15g mammals and 

freshwater invertebrates were exceeded. However, analysis of raw data from the mammalian and 

aquatic acute toxicity studies for clothianidin estimated a slope of 7.61 and 4.24 for mammals 

and freshwater invertebrates, respectively. Based on these slopes, the corresponding estimate 

chance of individual mortality following clothianidin exposure is only 1 in 7.21 x 1013 for small 

mammals and 1 in 5.76 x lo7 for freshwater invertebrates. 

Clothianidin's major risk concern is to nontarget insects (that is, honey bees). EFED expects 

adverse effects to bees if clothianidin is allowed to be sprayed on blooming, pollen-shedding, or 

nectar producing parts of plants. Clothianidin is a neonicotinoid insecticide that is both persistent 

and systemic. Acute toxicity studies to honey bees show that clothianidin is highly toxic on both 

contact and oral basis (contact LD,, = 0.044 pghee; oral LD,, = 0.0037 pghee). A registrant 

submitted residue foliage study (guideline 141-2) showed that clothianidin residues on foliage 

can be expected to remain toxic to bees for 5 days at an application rate of 0.07 lb ai/A from 

foliar sprays. Spray application rates proposed for the new uses to potatoes and grapes are 0.2 lb 

ai/A. Bees are attracted to blooming, pollen-shedding, and nectar producing parts of plants. 

Pesticides with residue toxicity greater than 12 hours will kill bees in substantial numbers if these 

pesticides are applied to the plant parts that attract bees. Because of this, EFED is recommending 

bee precautionary labeling prohibiting such clothianidin applications. 

EFED's May 2003 environmental risk assessment for seed treatment showed that use of 

clothianidin to rape (canola) results in detectable levels (ranging from 1.0 to 8.6 ppb) of 

clothianidin in the nectar sampled from honeybees' stomach, nectar from rape flowers, pollen 

from forage bees, pollen from bee hives, and nectar from bee hives. Detectable levels were 

found in the commodities sampled more than 60 days after the clothianidin treated seeds were 

planted. Although EFED was not able to make an adverse effect determination to honey bees, 

there was uncertainity about the sublethal or chronic risk to bees. At the time it was not clear 

what the effect of exposure on the forage force would be. Exposed foragers could become 

disoriented and fail to return to the colony.' However, this scenario is an uncertainty. The 

likelyhood of clothianidin residues being carried back to the hives resulting in accumulation of 

the pesticide thus adversely effecting the colonies health is also an uncertainty. As a result, 

EFED recommended a honey bee field study to answer these questions. 

' Other neonicotinoid compounds like imidacloprid (e.g., sunflower seed treatment) have resulted in incidents to honey bees. The 

National Union of French Beekeepers had concerns regarding imidacolprid (GAUCHO) seed treatment to sunflowers after beekeepers noted that 

honey bees were showing modifications of behavior that were reflected in foraging and orientation that eventually resulted in a drastic change in 

hive con&tions and bee survival. Further research by the Le Centre Technique Interprofessional des Oleaginenx (CETIOM) confirmed 

imidacloprid toxic residue levels in the sunflower nectar. This action has prompted France to ban the use of imidacloprid for sunflower seed 

treatment. 
EFED still has other uncertainties associated with seed treatment uses of clothianidin. These 

uncertainties are compounded with the new proposed uses of clothianidin. The earlier bee field 

studies for clothianidin demonstrated that clothianidin could be translocated to nectar and pollen 

in rape seed treatment use. EFED believes the proposed bee precautionary labeling would 

prevent clothianidin's direct foliar application to nectar or pollen producing parts of plants. 

However, EFED is uncertain about what would happen when foliar spray or granular applications 

of clothianidin are made prior to bloom. How likley could systemic clothianidin be translocated 

to the nectar or pollen producing parts of plants when applied as spray, as a granular or as a seed 

treatment? From the seed treatment field study results, it seems likely such a translocation would 

occur. If this were to occur, how much clothianidin can be expected in the nectar and pollen and 

would these amounts adversely affect bees? Because of this risk uncertainty EFED is requesting 

another field study for clothianidin's new proposed uses. 

Based on the proposed application rates, acute risk to avian and mammalian species is unlikely. 

Endangered 15g mammals (RQ = 0.12) may be at risk from ingestion of clothianidin treated food 

items. However, analysis of raw data from mammalian terrestrial acute toxicity studies for 

clothianidin provided an estimate of slope (7.61) for females only (LD50 = 389W465F mglkg). 

Based on this slope, the corresponding estimate chance of individual mortality following 

clothianidin exposure is only 1 in 7.2 1 x 1013 for small mammals. 

EFED identified residues on grasses and foliage (in nectar and pollen), residues in fruit, and 

depositions in soil as the most likely sources resulting in clothianidin exposure to nontarget 

terrestrial organisms. The terrestrial effects database for these species is incomplete and thus 

recommendations are made for additional studies or assessments to fill data gaps needed for a 

suitable screening level risk assessment. As part of the Tier 1 terrestrial assessment, EFED 

modeled exposure concentrations of clothianidin to nontarget terrestrial plants and animals 

following the proposed turfgrass application rates provided by the registrant. For terrestrial birds 

and mammals, estimates of initial levels of clothianidin residues on various food items, which 

may be contacted or consumed by wildlife, were determined using the Fletcher nomogram 

followed by a first order decline model. Avian acute and chronic RQs were below LOCs (0.5 to 

0.1 and 1, respectively). Mammalian chronic RQs do not exceed LOCs (highest RQ = 0.64 for 

clothianidin's use on turf). 

The risk concerns for non-endangered aquatic species were evaluated in a Tier II assessment 

using the PRZMIEXAMS model to predict surface water clothianidin concentrations. EFED 

identified spray drift and runoff to adjacent bodies of water as the most likely sources resulting in 

clothianidin exposure to nontarget aquatic organisms. The freshwater fish LC,,s (ranging from 

>I05 to > 117 ppm) showed clothianidin and it's degradates (TMG, MNG, and TZNG) were, 

practically nontoxic to freshwater fish. Since there were no mortalities or effects at these 

imprecise LC,, levels, which exceed predicted clothianidin EECs, EFED does not expect an 

acute risk to freshwater fish. Chronic exposure from the proposed clothianidin usage patterns 

should not pose direct risk to freshwater fish either. The chronic NOAEC for freshwater fish is 

9.7 ppm. Predicted exposure levels are below levels triggering a chronic risk to freshwater fish. 

EFED's risk assessment suggests that toxic risk to estuarinelmarine fish appears low, although 

there were no toxicity data to assess chronic risk. 
Clothianidin does not appear to present risk to terrestrial plants (there were no significant effects 

in the studies submitted). In addition, it does not appear to present risk to aquatic vascular or . 

nonvascular plants. 

For acute endangered aquatic species, levels of concern for freshwater invertebrates (RQs ranged 

from 0.067 to 0.086) were exceeded, should exposure actually occur. A probit slope response * 

relationship was evaluated to calculate the chance of an individual event corresponding to the 

listed species acute LOCs. Analysis of raw data from the aquatic acute toxicity studies for 

clothianidin estimate a slope of 4.24 (95% C.I. 0.276 and 8.22) for freshwater invertebrates. 

However, based on this slope, the corresponding estimate chance of individual mortality 

following clothianidin exposure is only 1 in 5.76 x lo7 for freshwater invertebrates. 

The RQ for 15g mammals slighty exceeded (RQ = 0.12) the endangered species LOC (0.1), thus 

risk is possible should exposure actually occur. Analysis of raw data from mammalian acute 

toxicity studies for clothianidin provided an estimate of slope (7.61). However, based on this 

slope, the corresponding estimate chance of individual mortality following clothianidin exposure 

is only 1 in 7.21 x loi3 for small mammals. 

There is uncertainty surrounding clothianidin's possible role as an endocrine disruptor as noted 

from mammalian developmental and reproductive effects. Data suggests that clothianidin could 

be a candidate for additional screening and/or testing to better characterize effects related to 

endocrine disruption. Effects in avian species included significant decreases in eggshell 

thickness. Effects in mammalian reproduction studies included decreased body weight gains and 

delayed sexual maturation (males only), decreased absolute thymus weight in F1 pups (both 

sexes), increased stillbirths (F1 and F2 litters), decreased sperm mobility and increased number 

of sperm with detatched heads (F1 and F2 litters). 

The available environmental fate data for clothianidin indicates that the chemical is highly 

persistent, mobile and systemic. It is stable to hydrolysis at all pHs at environmental 

temperatures, has the potential to leach to groundwater, be transported via runoff to surface water 

bodies, and could accumulate in soils from year to year with repeated uses. The major route of 

dissipation for clothianidin would appear to be photolysis if exposure to sunlight occurs (e.g. the 

measured aqueous photolysis half-life was el day and aerobic half-lives were 148 to 1155 days). 

Major degradates include TMG, MNG, and TZNG. 

The uncertainties associated with clothianidin exposure in the environment are mainly focused in 

these areas; 1) accumulation of clothianidin in soils after repeated uses and the potential for 

transportlmigration to surface water bodies and potential risk to sensitive aquatic invertebrates 

(e.g., sediment-dwelling benthic organisms); 2) repeated or continuous exposure of small 

mammals and birds to the pesticide presenting a potential reproduction and developmental risk; 

3) the possibility of toxic exposure to nontarget pollinators through the translocation of 

clothianidin residues to blooming, pollen-shedding or nectar-producing parts of plants that result 

from clothianidin's uses; and 4) repeated or continuous exposure to soil invertebrates and small 

mammals to clothianidin accumulated in soils after repeated uses. 

Prop~sed risk refinement measures include source control measures such as reduction in the 
application rate, reduction in the number of applications (especially in the presence of pollinators 

or nesting birds), and increasing the interval between applications may be implemented for 

clothianidin as possible risk reduction measures. Sediment toxicity testing of sensitive species 

(i.e. burrowing mayflies, 28-day chironomid study) would provide data to address the uncertainty 

of possible risk to invertebrates because clothianidin persists in the environment representing a 

continual source as an environmental sink. Aquatic field studies (simulated or actual) could be 

performed to determine system-wide effects to the assemblages of organisms in aquatic 

communities. In order to fully evaluate the possibility of chronic exposure to honey bees with 

subsequent impacts to pollination, a complete worker bee life cycle continues to be required as 

well as an evaluation of exposure and effects to the queen. Additional modeling should be done 

to sirmulate the potential affects of repeated uses in order to determine if reproduction and 

development are affected in birds, mammals, and soil invertebrates. 

11. PhysicaVChemical Properties Characterization 

A summary of selected physical and chemical parameters for clothianidin is presented in Table 

II.a. 

Chemical Family 

ColorIForm 

Odor 

Melting Point 

Flash Point 

Relative Density 

Water Solubility 

Neonicotinoid 

Clear and colorless/solid, powder 

odorless 

176.8"C 

N/ A 

1.61 g/ml (at 20°C), 1.59 g/cm3 

0.327glL (at 20°C) 
Solubility in other solvent 

dichloromethane 1.32 

methanol 6.26 

octanol0.938 

Pesticide Type, Class, Mode of Action 

Although nicotine has been used as a pesticide for over 200 years, it degraded too rapidly in the 

environment and lacked the selectivity to be very useful in large scale agricultural situations. 

However, in order to address this problem, the neonicotinoids (chloronicotinyl insecticides) were 

developed as a substitute of nicotine, targeting the same receptor site (AChR) and activating 

post-synaptic acetylcholine receptors but not inhibiting AChE. Clothianidin, like other 

neonicotinoids, is an agonist of acetylcholine, the neurotransmitter that stimulates the nAChR. In 

insects, neonicotinoids cause symptoms similar to that of nicotine. The symptoms appear rapidly 

as increased restlessness followed by violent convulsions and death. The advantage of 

clothianidin and other neonicotinoids over nicotine is that they are less likely to break down in 

the environment. 

111. Use Characterization 

Currently Approved Crops 

The following crops appear in the currently approved labels of clothianidin: 
Application Rates 

Table m.b. is a summary of the rates from the various product labels for all proposed 

applications. 

IV. Problem Formulation 

The planning stage for an ecological risk assessment entails initial discussions between risk 

assessor and risk manager in order to define time lines, management goals, and the problem 

formulation. The management goals for the registration of the new (uses of clothianidin is the 

protection of terrestrial and aquatic environments from unreasonable adverse effects (death or 

injury). 

Ground spray (including 

Problem formulation is the critical first step in establishing the direction and scope of an 

ecological risk assessment. Part A of the Guidelines for Ecological Risk assessment states that 

"in problem formulation, the purpose for the assessment is articulated, the problem defined, and 

a plan for analyzing and characterizing risk is determined." The analysis plan and rationale for 

developing a risk assessment for clothianidin is an iterative procedure for determining if the 

proposed new uses of this compound could result in residue exposure that has the potential for 

unreasonable adverse effects (risk) to nontarget organisms, as well as endangeredlthreatened 

organisms. The portion of the problem formulation which is an explicit statement of the 

characteristic of the environment to be protected is encompassed in a delineation of endpoints. 

These endpoints can include a particular species, a functional group of species, a community, or 

Grape 

Potato 

Grape 

Sorghum 

Cotton 

16 WSG 

ClutchTM 

50 WDG 

BelayTM 

16 WSG; 

ClutchTM 

50 WDG 

PonchoTM 600 

AE 1283742 

imidaclopridl 

clothianidin mix 

0.0667 

0.1 

0.02 

0.02 

3 

2 

NIA 

NIA 

0.2 

0.2 

0.02 

0.02 

14 

7 

NIA 

NIA 

drip irrigation/ 

chemigation) 

Foliar spray 

Foliar spray. Proposed 

Clutch label appears to 

only allow 2 app. @ 0.64 

lb. 

Seed treatment 

Seed treatment 
an ecosystem. 

Relative to the proposed use of clothianidin, EFED initially had concerns for risk to aquatic 

organisms due to high persistence and potential mobility of clothianidin to surface waters. In the 

case of this assessment, EFED relied on the clothianidin hazard assessment which considers 

I standard single chemical toxicity testing (acute and chronic endpoints) submitted by the 

registrant and reviewed by the Agency. EFED used this information for selection of the most 

sensitive species tested in order to generate RQ values. Effects data are included under the 

section "Characterization of Ecological Effects," and represent registrant submitted data. The 

effects database is mostly complete for freshwater and estuarinelmarine aquatic organisms and 

thus is suitable for a screening level risk assessment. The major endpoints related to aquatic 

environments at issue are: 

(a). Direct effects to aquatic invertebrates in the water column via acute toxicity. 

(b). Direct effects to benthic aquatic organisms dwelling in the sediment and/or pore 

water via acute and/or chronic toxicity. 

(c). Indirect effects to benthic community assemblages (i.e. reductions in diversity and 

abundance) dwelling in the sediment andlor pore-water. 

(d). Indirect effects to aquatic ecosystems from benthic community disturbances. 

In addition to the concern for aquatic ecosystems, EFED is also concerned with potential impacts 

to terrestrial species and functional groups, including pollinators; nectar and fruit eating birds, 

mammals, and insects; and soil-inhabiting invertebrates and mammals (i.e. earthworms, 

burrowing mammals). Available effects data are included under the section "Characterization of 

Ecological Effects," and represent registrant submitted data. Although EFED does not conduct 

RQ based risk assessments on beneficial insects, there is potential for direct toxic effects to 

honey bees as suggested by the toxicity data. The terrestrial effects database for these species and 

functional groups is incomplete and thus recommendations are made for additional studies or 

assessments to fill data gaps needed for a suitable screening level risk assessment. The major 

endpoints related to terrestrial environments at issue are: 

(a). Direct effects to mammals, insects, and soil invertebrates via acute toxicity. 

(b). Direct effects on reproduction to birds (eggshell thinning), mammals (endocrine 

disruption), and insects via chronic toxicity. 

(c). Direct effects to insects via toxicity of residues on foliage. 

(d). Direct effects to foraging activity of pollinators 

(e). Indirect effects from soil ecosystem alterations 

(f). Indirect effects from reduced crop yield from impact to pollinators. 

Problem formulation focused mainly on laboratory and field studies which indicate that 

clothianidin is persistent and mobile, stable to hydrolysis, has the potential to leach to 

groundwater, be transported via runoff to surface water bodies, and could accumulate in soils 

with repeated uses. Thus, the initial emphasis of the screening risk assessment was primarily 

about possible risk to freshwater and estuarinelmarine fish and invertebrates as well as to 

terrestrial birds, mammals, and invertebrates which may be exposed to residual clothianidin after 
spray and seed treatment applications. 

Tier I Aquatic Assessment 

Since clothianidin is not applied directly to water, EFED identified spray drift and runoff to 

adjacent bodies of water as the most likely sources resulting in clothianidin exposure to nontarget 

aquatic organisms. Relative to these uses, EFED examined the physical/chemical properties of 

clothianidin, its fate and disposition in the environment, and mode of application (e.g., seed 

treatment and foliar spray application) in order to develop a conceptual model (Figure 1.0). This 

scenario depicts seed treatment application to cotton and sorghum or spray application to grape 

and potato, which may cause spray drift and runoff subsequent to a rainfall event resulting in 

potential contamination of adjacent bodies of water. These events involve exposure of the 

stressor (clothianidin) to aquatic organisms (receptor). The direct predicted effects include acute 

morbidity, effects on growth, development, and reproduction. Indirect effects may include 

alterations in the diversity and abundance of benthic organisms, which in turn could affect fish 

populations resulting in possible adverse effects to fish population diversity, recreational 

fisheries and commercial aquaculture, should exposure occur. These indirect effects could result 

in ecosystem instability of water bodies receiving the spray drift and surface runoff. 

The Tier 11 assessment using the PRZMJEXAMS model to predict surface water clothianidin 

concentrations was sufficient for aquatic assessment. The environmental fate database is 

complete for the parent compound clothianidin and suitable for risk assessment. No 

transformation products were considered in the aquatic ecological assessment as the degradates 

database was incomplete with regard to environmental fate data. Degradates, such as MNG, 

TZMU, TZNG, TMG and NTG might potentially contaminate drinking water; however, because 

of the very long persistence of parent clothianidin (and relatively high soil mobility and low 

adsorption to soil and sediment) including the degradates in exposure modeling would not likely 

significantly increase the total exposure level estimates. Available toxicity data for the degradates 

indicates that with the exception of TZNG, the other degradation products (MNG, TMG, TZMU, 

and MU) either exhibited the same toxic responses as clothiniadin or were less toxic to aquatic 

organisms. Daphnia magna were more sensitive to TZNG than clothianidin with an acute 48-hr 

EC,, of 64 mg/L (NOEC of 11.2 mg/L) [MRID 454224011. All of the degradates were less toxic 

than clothianidin to Chironomus riparius (48-hr EC,,'s ranging from >83.6 - >I02 ppm). TZNG 

was also less toxic than clothianidin but more toxic than the other degradates with an EC,, of 

0.386 ppm) [MRD 454224141. Aquatic fate studies indicated that TMG was the primary 

degradate to accumulate significantly in the aerobic aquatic studies (which were not strictly 

aerobic in the sediment where the TMG was found) and that no degradate was found to 

accumulate significantly in the anaerobic aquatic studies. 

The Tier 11 level surface water assessment for clothianidin took into consideration registered and 

proposed label use patterns, application rates and methods of application. This infomation was 

used in combination with both registrant-submitted data (e.g., environmental fate and effects) and 

information gleaned from peer reviewed open literature, in order to characterize possible risk. 

In order to emphasize the relationships between the stressor (clothianidin) and the assessment 

endpoints, and to evaluate the potential risk to aquatic organisms from the use of clothianidin, 
risk quotients (RQs) were calculated. Risk quotients are calculated from the ratio of estimated 

~ environmental concentrations (EECs) to eco-toxicity values. EECs are developed using several 

models which are based on the maximum application rate of clothianidin for the proposed uses 

and the physical and chemical characteristics of clothianidin. These RQs were then compared to 

the LOC's used by EFED for determining potential risk to non-target organisms and the 

subsequent need for possible regulatory action. 

I 

I Tier I Terrestrial Assessment 

Through this evaluation, EFED identified residues on grasses and foliage (in nectar and pollen), 

residues in fruit, and depositions in soil as the most likely sources resulting in clothianidin 

exposure to nontarget terrestrial organisms. Relative to these uses, EFED examined the 

physical/chemical properties of clothianidin, its fate and disposition in the environment, and 

mode of application in order to develop a conceptual model (Figure 1.0). This scenario depicts 

ground application to grapes and potatoes in addition to seed treatment of sorghum and cotton. 

Laboratory and field studies indicate that clothianidin is highly persistent (aerobic soil 

metabolism and terrestrial field dissipation half-lives ranging from half a year to several years) 

and could accumulate in soils with repeated uses. Studies also indicate that residues of 

clothianidin are present in nectar and pollen of summer rape plants 60 days after application 

(MRID 45422431,45422432,45422433,45422435,45422436,454224371. These events 

involve exposure of the stressor (clothianidin) to terrestrial birds, mammals, and invertebrates 

(receptors). The direct predicted effects include acute morbidity, effects on growth, 

development, and reproduction, and effects on behavior (foraging activity of pollinators). 

Indirect effects may include toxic effects to soil communities due to the persistence/accumulation 

of clothianidin in soils from repeated uses and the potential for reduced crop yield from the 

impact to pollinators. 

As part of the Tier I terrestrial assessment, EFED modeled exposure concentrations of 

clothianidin to nontarget terrestrial plants and animals following the proposed application rates 

provided by the registrant. For terrestrial birds and mammals, estimates of initial levels of 

clothianidin residues on various food items, which may be contacted or consumed by wildlife, 

were determined using the Fletcher nomogram followed by a first order decline model. LD50 

sqlft estimates of risk were calculated for the seed treatment applications. 

In order to emphasize the relationships between the stressor (clothianidin) and the assessment 

endpoints, and to evaluate the potential risk to terrestrial organisms from the use of clothianidin, 

risk quotients (RQs) were calculated. Risk quotients are calculated from the ratio of estimated 

environmental concentrations (EECs) to eco-toxicity values. EECs are developed using several 

models which are based on the maximum application rate of clothianidin for the proposed uses 

and the physical and chemical characteristics of clothianidin. These RQs were then compared to 

the LOC's used by EFED for determining potential risk to non-target organisms and the 

subsequent need for possible regulatory action. 

V. Analysis 

Analysis is a process that examines the two primary components of risk, exposure and effects, 

and their relationships between each other and site characteristics. The objective is to provide the 
ingredients necessary for determining or predicting ecological responses to pesticide uses under 

exposure conditions of interest. The products of analysis provide the basis for estimating and 

describing risks in risk characterization. 

Environmental Fate Characterization 

Summary 

Clothianidin appears to be a persistent compound under most field conditions. Based on analysis 

of the laboratory studies alone, the major route of dissipation for clothianidin would appear to be 

photolysis if exposure, to sunlight occurs (e.g., the measured aqueous photolysis half-life was <1 

day and aerobic half-lives were 148 to 1155 days). Although photolysis appears to be much more 

rapid than other avenues of degradationldissipation of clothianidin in the laboratory studies, the 

very slow rate of dissipation that was observed in field studies suggests that photolysis probably 

is not significant under most actual-use conditions. Photolysis may be quite important in surface 

waters if residues have reached'clear bodies of water and are in solution rather than bound to 

sediment. Clothianidin is stable to hydrolysis at environmental pHs and temperatures. 

Degradation is also relatively rapid under anaerobic aquatic conditions (overall half-life of 27 

days); however, metabolic degradation occurs very slowly in aerobic soil. Clothianidin is mobile 

to highly mobile in the laboratory [soil organic carbon partition coefficients (Koc) values were 84 

to 129 for all test soils except for a sandy loam soil which had a Koc value of 3451, although only 

a modest amount of leaching was observed in the submitted field studies. Previous studies have 

confirmed that compounds with a similar combination of mobility and persistence characteristics 

have a potential to leach to ground water at some use sites. Volatilization is not expected to be a 

significant dissipation process. 

Degradation and Metabolism 

Metabolism in aerobic soil occurred very slowly. At 20°C, clothianidin degraded in two soils 

with a first-order half-life of 148 and 239 days (Hofchen and Laacher soil series), in seven soils 

ranging in texture from sand to silt loam with half-lives of 495 to 1,155 days (BBA 2.2, Quincy, 

Sparta, Crosby, Susan, Elder, and Howe soil series), and in a tenth soil with a half-life that was 

nominally calculated to be 6,931 days (Fugay soil series). Degradation was too little in the Fugay 

soil study to accurately calculate the degradation rate over the 1-year study period (r2 = 0.05). 

Under anaerobic aquatic conditions, metabolic degradation occurred relatively quickly (half-life 

of 14 days in water; 37 days in sediment; 27 days overall). Clothianidin was <1% of the applied 

in the water at and after 120 days and was ~2.0% in the silt loam sediment at and after 183 days. 

No major degradates were isolated; clothianidin was converted primarily to soil-bound residues. 

Clothianidin photodegraded with half-lives of c1 day in sterile buffer solution in the laboratory 

and in natural water outdoors, and approximately 34 days in soil in the laboratory. The range of 

values (1 to 34 days) given for surface water-source drinktng water represents uncertainty with 

regard.to the importance of photodegradation in the long-term fate of clothianidin in natural 

waters. In the laboratory, clothianidin photodegraded in sterile aqueous pH 7 buffer solutions 

with a half-life of 6.2-6.8 hours, based on a 12-hour lightll2-hour dark cycle. Major degradates 

were N-(2-clorothiazol-5-ylmethy1)-N'-methylurea (TMZU), methylurea (MU), methylguanidine 
(MG), 4-hydroxy-2-methylamino-2-imidazolin-5-0 (HMIO), 7-methylamino-4H-imidazo[5,1- 

b][l,2,5]thiadiazin-4-one (MIT), formamide (FA), and CO,. Outdoors, clothianidin degraded in 

nonsterile river water with a half-life of 25.1 to 27.7 hours under a cycle of approximately 9 

hours sunlight115 hours darkness. Major transformation products were MG, HMIO, MU, Urea, 

TMG, 3-methylamino-1H-imidazo [1,5-climidazole (MAI), 2-chlorothiazol-5-ylmethanol 

(CTCA), and CO,. There was no degradation in the control samples held in the dark, which is 

consistent with clothianidin's observed stability to hydrolysis. 

On moist soil, clothianidin photodegraded with a half-life of 8.2 days based on continuous 

irradiation (estimated to be equivalent to 34.2 solar summer days in Phoenix, AZ); degradation 

was not significant in the dark. At study termination (equivalent to 71 days solar summer days in 

Phoenix, AZ), 22.3% of the clothianidin remained undegraded. No degradates accumulated to 

significant levels during the study. 

Soil sorption and mobility 

In laboratory batch equilibrium studes, clothianidin had medium mobility in a US sandy loam 

soil and high mobility in US loamy sand and clay loam and German sand and sandy loam soils. 

In batch equilibrium studies using the same soils and similar conditions, MNG was very highly 

mobile, TZMU was highly to very highly mobile, TZNG was moderately mobile, and TMG was 

immobile or had low mobility. The mobility of clothianidin appeared to decrease as the length of 

time clothianidin was in contact with the soil increased; the longer clothianidin was aged in 

treated soil, the less likely it was to desorb from that soil. 

Field dissipation 

Clothianidin is expected to dissipate very slowly under terrestrial field conditions, based on the 

results of five bare ground field experiments conducted in the US and Canada. Half-lives of 

clothianidin, based on residues in the 0-15 cm soil depth, were 277 days (Wisconsin sand soil, 

incorporated), 315 days (Ohio silt loam soil, not incorporated), 365 days (Ontario silt loam soil, 

incorporated), and 1,386 days (North Dakota clay loam soil, not incorporated), and could not be 

determined at a fifth site due to limited dissipation during the 25-month study (Saskatchewan 

silty clay loam soil, incorporated). Incorporation did not appear to be a significant factor in 

determining the rate of dissipation. Clothianidin was generally not detected below the 45 cm soil 

depth except at one site, where it moved into the 45-60 cm depth. No degradates were detected 

at rl0% of the applied, and degradates were generally only detected in the 0-'15 cm soil layer. 

Hohever, in many cases most of the parent remained untransformed at the close of the study; 

further accumulation of degradates could have occurred. Degradates that were increasing in 

concentration or at least continuing to persist towards the close of one or more field dissipation 

studies were: MNG (MRID 45422336) TZNG (MRID 45422335,45422333), and TZMU 

(MRID 45422335). 

Two studies were conducted to investigate leaching of clothianidin under field conditions 

(MRIDS 45422331 and 45422508). These studies were conducted in the Federal Republic of 

Germany and were apparently designed to fulfill certain European regulatory requirements. In 

these monolith lysimeter studies, 42 to 59% of the applied remained in the soil approximately 3 

to 4 years following the first of two applications, and residues were primarily undegraded 
clothianidin. The loss of radioactivity was attributed by the authors to mineralization of 

clothianidin, since I 1% of the total residues were detected in the leachate. Clothianidin was not 

detected in the leachate. There was also a significant amount of TZNG and/ or MNG that 

remained in monolith lysimeters at the close of multi-year studies. In one study (MRID 

45422331), analysis of the soil in the lysimeter three years after the original application of 

clothianidin revealed TZNG was present as about 5% of the applied clothianidin. When the soil 

was analyzed more than 4 years after application in another lysimeter study (MRID 45422508) 

about 3% of the applied was present as MNG and 2% was present as TZNG. The substantial 

amount of clothianidin parent remaining in the soil profile at the close of these studies indicates 

that further leaching of clothianidin may occur in following years if sufficient precipitation 

occurs. 

Aquatic Exposure Characterization 

Based on laboratory and field studies, the available data on clothianidin show that the compound 

is persistent and mobile, stable to hydrolysis and has potential to leach to groundwater as well as 

to runoff to surface waters. Assessments in this analysis have been based on the contamination 

potential of the parent compound clothianidin, which appears to be the most significant 

contaminant of surface and ground waters. However, we note that limited environmental fate 

data for the degradates indicate that some of these compounds may be mobile and persistent. 

Tier 11 EECs for clothianidin were calculated using PRZMIEXAMS. PRZM/EXAMS is a 

screening model designed to estimate the pesticide concentration found in water for use in 

ecological assessments. - 

While no groundwater monitoring studies have been conducted, the registrant did submit 

monolith lysimeter study results. In these studies, (MRIDS 45422508 and 4542233 1) there was 

no parent clothianidin detected in the leachate. The degradates were detected in small quantities 

in the leachate. In one study, MNG and NTG were detected in leachate samples; in the other 

study none of the degradates in the leachate were identified. Clothianidin was extremely 

persistent and still potentially available for leaching at the close of the lysimeter studies (3 or 4 

years after initial application), in both studies 42 to 59% of the applied radioactivity remained in 

the soil approximately 3 to 4 years following the first two applications and residues were 

primarily undegraded clothianidin. These results highlight the potential for very high 

persistence of clothianidin and some degradates and the possibility of leaching to groundwater 

occurring even in soils of fairly low permeability several years after application of clothianidin. 

i 

The current exposure assessment is based solely upon the parent compound. Our understanding 

of the potential exposure to degradates of clothianidin is constrained by the high persistence of 

clothianidin parent and the concomitant lack of significant accumulation of any specific product 

in most laboratory and field studies. Major degradates detected in one or more of the aqueous 

photolysis studies which might or might not be important under some actual use conditions are 

TZMU, TMG, MU and MG (however, these studies were of very short duration and these 

degradates did not accumulate in the longer 17-day soil photolysis studies). TZMU was shown to 

be an important hydrolysis product in pH 9 solution at elevated temperature (no significant 

hydrolysis was observed at any pH at 25' C). Little degradation of parent occurred in each of the 
10 soils used for aerobic metabolism investigation (54 to 95% of the parent compound remaining 

in the soil at the close of these studies) but there was still some evidence of accumulation of 

TZNG, MNG and NTG in some of the test soils. TMG accumulated significantly in the aerobic 

aquatic studies (which were not strictly aerobic in the sediment where the TMG was found). In 

the anaerobic aquatic study, no degradate was found to accumulate significantly. In soil 

adsorption - desorption studies, MNG and TZMU were shown to be extremely mobile in soil and 

could, if they form and persist in the soil, be significant ground water contaminants. All four of 

the degradates for which soil sorption was investigated (MNG, TZMU, TZNG and TMG) could 

occur in runoff water if they form in significant amounts. No soil sorption studies were 

conducted for NTG. We conclude that degradates such as MNG, TZMU, TZNG, TMG and NTG 

might potentially contaminate water; however, because of the very long persistence of parent 

clothianidin (and relatively high soil mobility and low adsorption to soil and sediment) including 

the degradates in exposure modeling would not likely significantly increase the total exposure 

level estimates. 

Estimated Environmental Concentrations (EECs) for Aquatic Ecological Effects 

Table Va summarizes the input values used in the PRZM/EXAMS model. Fate parameters were 

obtained from studies submitted by the registrant and modified, if necessary, according to the 

Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of 

Pesticides, Version 11 (February 28,2002). The modeling results associated with the maximum 

allowable rate per year for representative crops are presented in Table Vb. 

Page 13 of 110 

Aquatic photolysis half-life 

photolysis hald-life because of demonstrated 

persistence in water and on soil surface exposed to 

Organic carbon partition 

coefficient (KOC) 

Soil aerobic metabolic halfLife (days) 

Aquatic metabolic half-life 

(days) 

188 

744* 

1,488 

454223 19, 

45422321 (water) 

MRID 454223 11 

MRIDs 45422325; 

45422326 

MRID 45422324 

sunlight. Lower value of 1.1 days from natural water 

photolysis study was liot used in the modeling for 

this assessment. 

Mean Value 

90% upper confidence bound on 9 values. 

2X aerobic soil half-life used since there was no 

acceptable aerobic aquatic study 

Table V.b. below summarizes results from PRZMlEXAMS. 

-- 

Sorghum (seed) 

Cotton (seed) 

Grape 

Grape 0.1 2 1.070 0.916 0.849 

Potato 0.2 1 1.408 0.548 0.232 

Potato 0.0667 3 1.897 1.045 0.870 

Terrestrial Effects Characterization 

Avian and Mammalian Species 

An extensive assessment of the potential exposure and risk to avian guideline species exposed to 

clothianidin by oral intubation or in the diet concluded that clothianidin was moderately toxic to 

bobwhite quail on an acute basis (LD,,> 200 mglkg) and non-toxic to the mallard duck and 

bobwhite quail on a sub-acute basis (5 day LC,, >5040 ppm and 5230 ppm), respectively. A Tier 

I screening assessment based on the exposure of bobwhite quail to residual clothianidin after 

application (0.2 lb ai/A maximum application rate) was performed using the FATE model. 

Based on the proposed uses and application rates of clothianidin in this assessment, it is assumed 

acute exposure to avian species as the result of residual product on grass, fruits and berries as the 

result of field application would not present a risk to avian species. 

The submitted chronic toxicity data show that exposure of 525 ppm of clothianidin in the diet 

adversely affected eggshell thickness (MRID #45422421). Because birds may be subject to 

repeated or continuous exposure to the pesticide, especially preceding or during the breeding 

season, additional modeling should be done to determine if birds are at risk from repeated uses of 

clothianidin. 

Likewise, an assessment of potential exposure and risk to small mammals exposed to 

clothianidin by the oral route suggests that clothianidin is moderately toxic to small mammals on 
an acute oral basis (mouse LD,, = 389 to 465 mglkglday). A Tier I screening assessment based 

on the exposure of a mouse to residual clothianidin after application (0.2 lb ai/A maximum 

application rate) was performed using a FATE based model. Based on the proposed uses and 

application rates of clothianidin in this assessment it is assumed acute exposure to mammalian 

species as the result of residual product on grass, fruits and berries as the result of field 

application should not present risk. The RQ (0.12) for endangered 15g mammals exceeded the 

LOC. However, analysis of raw data from mammalian terrestrial acute toxicity studies for 

clothianidin provided an estimate of slope (7.61). Based on this slope, the corresponding 

estimate chance of individual mortality following clothianidin exposure is only 1 in 7.21 x 1013 

for small mammals. 

Reproduction studies in rats indicate that concentrations of 500 ppm clothianidin resulted in 

increased stillbirths and delayed sexual maturation in males. Developmental studies in rabbits 

indicate that concentrations of 75 mglkglday resulted in premature deliveries, decreased gravid 

uterine weights, and increased litter incidence of missing lung lobeslfetus. Because small 

mammals may feed on fruit or burrow in the soils and thus, be subject to repeated or continuous 

exposure to the pesticide, additional modeling should be done to determine if mammals are at 

risk from repeated uses of clothianidin. 

Nontarget Insects and Terrestrial Invertebrates 

Currently, EFED does not assess risk to nontarget insects or terrestrial invertebrates using the 

risk quotient method. However, it appears that clothianidin exposure to honeybees has the 

potential for high toxicity on both an acute contact and oral basis. Acute toxicity studies to 

honey bees show that clothianidin has the potential to be highly toxic on both a contact and an 

oral basis (contact LD,, = 0.044 pghee; oral LD,, = 0.0037 pghee), while its degradates (e.g.,, 

TMG, MNG, TZMU, and TZNG)'~~~ moderately to practically non-toxic on an oral basis (LD,, 

= 3.9 - >I53 pgbee). One honey bee field study (MRID # 45422435) showed that mortality, 

polleh foraging activity, and honey yield were negatively affected by residues of clothianidin; 

howeyer, residues were not quantified in this study. Another honey bee field study (MRID 

45422440) showed that pollen treated with clothianidin at a measured concentration level up to 

19.7 pg a.i./kg produced no significant adverse effects to mortality, foraging activity (including 

pollen and honey collection), comb production, honey storage behavior, population growth 

(including egg, larvae, pupae, and adult growth stages), and behavioral anomalies. However, 

only one replicate hive per treatment level was tested, therefore, statistical analysis of the data 

could1 not be performed. 

Pesticides toxic to honey bees require bee precautionary labeling on all end-use formulations and 

registrants are required to submit data in accordance with Guideline 141-2 - Honey Bee Toxicity 

of Residues on Foliage. A scientifically sound study was performed. Alfalfa foliage was sprayed 

with Clothianidin, as V-10066, at application rates of 30,60, and 90 g a.i./acre. Honey bees, 

three replicateslrates, were exposed in the lab to the weathered foliage at varying times until the 

mortality of bees exposed to residues was lower than 25%. Sublethal observations were also 

Page 16 of 110 
made. The RT,? for clothianidin (V-10066) at 30 (0.07 lb ai/A), 60 (0.13 lb ai/A), and 90 (0.21 

lb ai/A) g a.i./acre were 111.68 (4.7days), 179.51 (7.5days), and 512.39 (21.3days) hours, 

respectively. The rates of application were determined to be highly hazardous to honey bees. 

Results indicate that clothianidin, as V-10066, should not be applied to blooming, pollinating, or 

nectar producing parts of plants. 

Subchronic invertebrate toxicity studies showed that clothianidin adversely affected earthworm 

mortality and body weight (LC,, = 15.5 ppm) and its degradates reduced body weight (LC,, = 

982.6 ppm). There were no apparent effects of clothianidin on earthworm reproduction or 

population dynamics. 

VI. Risk Characterization 

Risk Estimation 

A means of integrating the results of exposure and ecotoxicity data is called the deterministic 

method. For this method, risk quotients (RQs) are calculated by dividing exposure estimates by 

ecotoxicity values, both acute and chronic. 

RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used by 

OPP to indicate potential risk to non-target organisms and the need to consider regulatory action. 

The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on 

non-target organisms. LOCs currently address the following risk presumption categories: (1) 

acute high - potential for acute risk is high, regulatory action may be warranted in addition to 

restricted use classification (2) acute restricted use - the potential for acute risk is high, but this 

may be mitigated through restricted use classification (3) acute endangered species - the 

potential for acute risk to endangered species is high, regulatory action may be warranted, and (4) 

chronic risk - the potential for chronic risk is high, regulatory action may be warranted. 

Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks 

to non-target insects, or chronic risk from granularhait formulations to mammalian or avian 

species. 

The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk 

quotients are derived from the results of required studies. Examples of ecotoxicity values 

derived from the results of short-term laboratory studies that assess acute effects are: (1) LC50 

(fish and birds) (2) LD50 (birds and mammals) (3) EC50 (aquatic plants and aquatic 

invertebrates) and (4) EC25 (terrestrial plants). An example of a toxicity test effect level derived 

from the results of long-term laboratory studies that assess chronic effects is: (1) NOAEC (birds, 

2 RT,, is the residual time required to reduce the activity of the test material and bring bee mortality down to 25% in cage 

test exposures to field-weathered spray deposlts (Mayer and Johansen, 1990). The time period determined by this 

toxicity value is considered to be time that the test materlal is expected to remain toxic to bees in the field from the 

resldual exposure of the test material on vegetation at an expressed rate of application (lb aiIA). 

Page 17 of 110 
fish and aquatic invertebrates). 

Risk presumptions, along with the corresponding RQs and LOCs are tabulated below: 

Table V1.a. Risk Presuinptions for Terrestrial Animals 

Risk Pres~rnrption RQ LOC 

Birds: 

Acute High Risk EEC1/LC50 or LDSOIsqff or ~D50Iday~ 0.5 

Acute Restricted Use EECLC50 or LD5OIsqft or LD5OIday (or LD50 < 50 mglkg) 0.2 

Acute Endangered Species EECILCSO or LDSOlsqft or LDSOlday 0.1 

Chronic Risk EECNOAEC 1 

Wild Mammals: 

Acute High Risk EECKSO or LDSOIsqft or LD5OIday 0.5 

Acute Restricted Use EECfLC50 or LDSO/sqft or LD501day (or LD50 < 50 mgkg) 0.2 

Acute Endangered Species EEC/LCSO or LDSOlsqft or LDSOIday 0 1 

Chronic Risk EEC/NOAEC 1 

EEC=abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items 

m&ft2 ma of toxicant consumedlday 

LD50 * wt. of bird LD50 * wt. of bird 

Table V1.b. Risk Presumptions for Aquatic Animals 

Risk Presumption RQ LOC 

Acute High Risk 

Acute Restricted Use 

Acute Endangered Species EECILC5O or EC50 0.05 

Chronic Risk EECMATC or NOAEC 1 

EEC = (ppm or ppb) in water 

Page 18 of 110 
Table V1.c. Risk Presumptions for Plants 

Risk Presurnprion RQ LOC 

Terrestrial and Semi-Aquatic Plants: 

Acute High Risk EEC1/EC25 1 

Acute Endangered Species EECECOS or NOAEC 1 

Aquatic Plants: 

Acute High Risk EEC2/EC50 1 

Acute Endangered Species EECECOS or NOAEC 1 

' EEC = lbs ai/A 

EEC = (ppblppm) in water 

Exposure and Risk to Nontarget Freshwater Aquatic Animals 

Non-target aquatic organisms (freshwater and estuarinelmarine fishes and invertebrates) can be 

exposed to clothianidin by spray drift and runoff into surface water. 

Fresh water Fish 

Acute and chronic risk quotients are tabulated in Table V1.d. An analysis of the acute test results 

show there were no mortalities or effects at the indefinite LC,,s shown and, though indecisive, 

these acute toxicity values are well above predicted EECs. Because of this, EFED did not 

calculate acute RQ values for the proposed uses. EFED does not expect risk to freshwater fish. 

Chronic exposure from the proposed clothianidin usage patterns should not pose direct riskto 

freshwater fish either. The chronic NOAEC for freshwater fish is 9.7 ppm. These predicted 

exposure levels are below levels triggering a chronic risk to freshwater fish. 

Page 19 of 110 
Potato (0.2 x 1) Rainbow >I05 NIA 1.408 NIA 0.00 N/A 

trout 

Fathead 

Minnow N/A 9.7 NIA 0.232 N/A 0.00 

Potato (0.0667 x3) Rainbow >I05 N/A 1.897 N/A 0.00 NIA 

trout 

Fathead 

Minnow NIA 9.7 N/A 0.870 NIA 0.00 

Grape (0.2 x 1) Rainbow >I05 NIA 0.600 NIA 0.00 NIA 

trout 

Fathead 

Minnow NIA 9.7 N/A 0.546 NIA 0.00 

Grape (0.01 x 2) Rainbow >I05 N/A 1.070 N/A 0.00 N/A 

trout 

Fathead 

Minnow N/A 9.7 N/A 0.849 NIA 0.00 

Sorghum seed (0.02 x 1) Rainbow >I05 NIA 0.044 N/A 0.00 N/A 

trout 

Fathead 

Minnow NIA 9.7 N/A 0.041 NIA 0.00 

Cotton seed (0.02 x 1) Rainbow >I05 NIA 0.153 NIA 0.00 NIA 

trout 

Fathead 

Minnow N/A 9.7 NIA 0.143 NIA 0.00 

Freshwater Invertebrates 

Page 20 of 1 10 
The acute and chronic risk quotients are tabulated in Table V1.e. EFED's evaluation of the 

calculated RQ values show that the proposed use of clothianidin on potatoes may result in acute 

risk to endangered aquatic freshwater invertebrates (RQs ranged from 0.00 to 0.086). Chronic 

RQ values (RQs ranged from 0.00 to 0.14) for freshwater invertebrates appear to be below 

EFED's LOC, suggesting low chronic risk. 

Page 21 of 110 

--- ----- 
Potato (0.2 x 1) Chironomus 0.022 NIA 1.408 NIA 0.067 NIA 

riparius 

Daphnia NIA 0.042 NIA 0.548 NIA 0.013 

magna 

Potato (0.0667 x 3) Chironomus 0.022 NIA 1.897 NIA 0.086 NIA 

riparius 

Daphnia NIA 0.042 NIA 1.045 N/A 0.024 

magna 

Grape (0.2 x 1) Chonomus 0.022 NIA 0.600 NIA '0.027 NIA 

riparius 

Daphnia NIA 0.042 NIA 0.577 NIA 0.14 

magna 

Grape (0.1 x 2) Chironomus 0.022 NIA 1.070 NIA 0.048 NIA 

ripanus 

Daphnia NIA 0.042 NIA 0.916 NIA 0.02 1 

magna 

Sorghum seed (0.02 x 1) Chironomus 0.022 NIA 0.044 NIA 0.00 NIA 

riparius 

Daphnia NIA 0.042 NIA 0.043 NIA 0.00 

mama 

Cotton seed (0.02 x 1) Chironomus 0.022 NIA 0.153 NIA 0.00 NIA 

riparius 

Daphnia NIA 0.042 NIA 0.149 NIA 0.00 

mama 

'Chironomus riparius 48hr EC50 = 0.022 ppm 

Daphnia magnia NOAECILOAEC = 0.04210.12 ppm reproductive effects 

Page 22 of 1 10 
Estuarine and Marine Fish 

The acute risk quotients are tabulated in Table V1.f. An analysis of the acute test results show 

that since there were no mortality or effects (limited studies) RQ values would not be calculated 

for the proposed usage and that acute risk to estuarinelmarine fish is not expected. 

Potato (0.2 x 1) Sheepshead >93.6 N/A 1.408 0.00 N/A 

Potato (0.0667 x3) Sheepshead >93.6 N/A 1.897 0.00 N/A 

Grape (0.2 x 1) Sheepshead >93.6 N/A 0.600 0.00 NIA 

Grape (0.1 x 2) Sheepshead >93.6 N/A 1.070 0.00 N/A 

Sorghum seed (0.02 x 1) Sheepshead >93.6 N/A 0.044 0.00 N/A 

Cotton seed (0.02 x 1) Sheepshead >93.6 N/A 0.153 0.00 N/A 

Estuarine and Marine Invertebrates 

The acute and chronic risk quotients are tabulated in Table V1.g. EFED's evaluation of the 

calculated RQ values show that the proposed use of clothianidin should not result in acute risk to 

aquatic estuarinelmarine invertebrates (RQs ranged from 0.00 to 0.04). Chronic RQ values (RQs 

ranged from 0.0 to 0.20) also do not exceed the LOC and suggest low chronic risk to 

estuarinelmarine invertebrates. 

Potato (0.2 x 1) Mysid 0.051 0.0051 1.408 0.548 0.03 0.10 

Potato (0.0667 x 3) Mysld 0.051 0.0051 1.897 1.045 0.04 0.20 

Grape (0.2 x 1) Mysid 0.051 0.0051 0.600 0.577 0.01 0.11 

Grape (0.1 x 2) Mysid 0.051 0.0051 1.070 0.916 0.02 0.18 

Sorghum seed (0.02 x 1) Mysid 0.051 0.0051 0.044 0.043 0.00 0.00 

Cotton seed (0.02 x 1) Mysid 0.051 0.0051 0.153 0.149 0.00 0.00 

Page 23 of 1 10 
Terrestrial Risk Quotients and Comparison to LOCs 

Avian and Terrestrial Mammals 

Predicted residual concentrations (EECs) of clothianidin were compared to toxicity values for 

northern bobwhite quail and mouse to estimate acute and chronic risk quotients (Table VI h). 

The quail and mouse were chosen as representative terrestrial bird and mammal, respectively. 

Avian acute and chronic RQs were less than the LOCs (0.5 to 0.1 and 1, respectively). However, 

the mammalian acute RQ (RQ = 0.12) for 15g mammals slightly exceeded the endangered 

species LOC of 0.1. Mammalian chronic RQs did not exceed chronic LOCs for both endangered 

and non-endangered species. Neither endangered and non-endangered birds or mammal species 

are at risk from ingestion of clothianidin treated seed (Table VI i). It would seem unlikely birds 

or mammals would or could ingest the amount of seed needed to reach an LD50 dose. 

Grapes and Avian EEC 48 22 27 3 

potatoes Acute 0.00 0.00 0.00 0.00 

0.2 x 1 app Chronic 0.2 0.1 0.1 0.07 

Grapes and Mammal EEC 48 22 27 3 

potatoes Acute (15g) 0.12 0.05 0.06 0.00 

0.2 x 1 app Acute (35g) 0.08 0.04 0.04 0.00 

Acute (1 000g) 0.019 0.00 0.01 0.00 

Chronic 0.3 0.1 0.2 0.02 

RQs determined by a FATE based model. Avian RQs based on bobwhite qua11 acute and chronic toxicity values. Mammalian 

RQs based on acute mouse toxicity values. 

Table V1.i 

Avian Acute Risk Quotients for Single Applications of Clothianidin Treated Seed Based on a Japanese Quail 

(Coturnix coturnix japonica) 

SitdApplication 

Method 

Pounds Planted Seed 

per Acre3 

Seed Treatment (lb 

dl00 lb seed) 

Row width (feet) 

Cottona/In-furrowIncorporated 

10 

0.22 

0.1 

Sorghumb/In-furrowIncorporated 

9 

0.25 

0.1 

Page 24 of 1 10 

LD50 of 

Application 

Rate 

(lb ai/A) 

0.022 

0.022 

423 mg 

Bird 

Body 

Weight 

(grams) 

20 

180 

1000 

20 

180 

1000 

ail&. 

% 

(decimal) 

of 

Pesticide 

Left on 

the 

Surface 

0.01 

0.01 

I 

Exposed 

(mg dsq. 

ft) 

0.07 

0.03 

Acute RQ 

(LDSOIsq. 

ft) 

0.0081 

0.0009 

0.0002 

0.0035 

0.0004 

0.0001 

Seeds per 

pound 

3,636 

25,000 

Mg ai 

per 

seed 

0.27 

0.045 

Number of 

Seeds 

Consumed to 

Reach LD50 

3 1 

278 

1,544 

187 

1,679 

9,326 
1 Exposed = App. Rate (lbs ai/A)* 453,590 mgllbs * % (decimal) on surfacel[linear ft of rowlA (ft/A)* row 

width(ft)] 

2 RQ = Exposed (mg ai/sq ft)/[LD5O (mg ai/kg) * Weight of the Animal (g)/1000 (glkg)] 

RQ greater or equal to 0.5 exceeds acute high, acute restricted use and acute endangered species LOCs. 

RQ greater or equal to 0.2 exceeds acute restricted use and acute endangered species LOCs. 

RQ greater or equal to 0.1 exceeds acute endangered species LOCs. 

3 Sources: Cotton: (EPA file source); Code of Federal Regulations, Section 7, Part 201, Federal Seed Act 

Regulations (2003) & AE 1283742 label 

Sorghum: (EPA file source); Code of Federal Regulations, section 7, Part 201, Federal Seed Act 

Regulations (2003); & Clothianidin 600 FS label 

4 Mg ai per seed = seed treatment rate (Ib ail1001b seed)/100 lb seedlseeds per lb * 453,590 mg/lb 

5 Number of Seeds Consumed to Reach LD50 = [LD5O(mg ailkg) * Weight of the Animal (g)/1000 (g/kg)]lmg ai per 

seed 

6 Incorporation effieciency: Banded (covered with specified amount of soil), in-furrow, drill or shanked-in = 99% 

Side-dress, banded or broadcst (all mixed or lightly incorporated with soil) = 85% 

Side-dress, banded, broadcast, aerial broadcast (all unincorporated) = 0% 

a Assumes 36 inch row spacing or 14,520 linear ft of row per acre 

b Assumes 15 inch row spacing or 34,848 linear ft of row per acre 

Page 25 of 1 10 

Mammalian Acute Risk Quotients based on LD50 sq ft for Single Applications of Clothianidin Treated Seed 

Based on a Mouse 

SiteIApplicat 

ion Method 

Pounds 

Planted Seed 

per Acre3 

Seed 

Treatment 

(lb ail100 lb 

seed) 

Row width 

(feet) 

Cottona/InfurrowIncorporated 

10 

0.22 

0.1 

Sorghumb/InfurrowIncorporated 

9 

0.25 

0.1 

1 Exposed = App. Rate (lbs ai/A)* 453,590 mg/lbs * % (decimal) on surface/[linear ft of rowlA (ft/A)* row width 

(ft)l 

2 RQ = Exposed (mg ailsq ft)/[LD50 (mg ailkg) * Weight of the Animal (g)/1000 (glkg)] 

RQ greater or equal to 0.5 exceeds acute high, acute restricted use and acute endangered species LOCs. 

RQ greater or equal to 0.2 exceeds acute restricted use and acute endangered species LOCs. 

(Mus 

Application 

Rate 

(lb ai/A) 

0.022 

0.022 

musculus) LD50 

Mammal 

Body 

Weight 

(grams) 

15 

35 

1000 

15 

35 

1000 

of 389 mg 

% 

(decimal) of 

Pesticide 

Left on the 

Surface6 

0.01 

0.01 

ailkg. 

Exposed ' 

(mg ailsq. 

ft) 

0.07 

0.03 

Acute RQ 

(LD50Isq. ft) 

0.012 

0.005 

0.0002 

0.0050 

0.0022 

0.0001 

Seeds per 

pound 

3,636 

25,000 

Mg ai per 

seed 

0.27 

0.045 

Number of 

Seeds 

Consumed 

to Reach 

LD50 

2 1 

50 

1,420 

129 

300 

8,576 
RQ greater or equal to 0.1 exceeds acute endangered species LOCs. 

3 Sources: Cotton (EPA file source); Code of Federal Regulations, Section 7, Part 201, Federal Seed Act 

Regulations (2003) & AE 1283742 label 

Sorghum: (EPA file source); Code of Federal Regulations, Section 7, Part 201, Federal Seed Act 

Regulations (2003); & Clothianidin 600 FS label 

4 Mg ai per seed = seed treatment rate (lb ai11001b seed)/100 lb seedlseeds per lb * 453,590 mgllb 

5 Number of Seeds Consumed to Reach LD50 = [LD5O(mg ailkg) * Weight of the Animal (g)/1000 (g/kg)]/mg ai per I seed 

6 Incorporation effieciency:Banded (covered with specified amount of soil), in-furrow, drill or shanked-in = 99% 

Side-dress, banded or broadcst (all mixed or lightly incorporated with soil) = 85% 

Side-dress, banded, broadcast, aerial broadcast (all unincorporated) = 0% 

a Assumes 36 inch row spacing or 14,520 linear ft of row per acre 

b Assumes 15 inch row spacing or 34,848 linear ft of row per acre 

Nontarget Insects and Plants 

Insects 

Currently, EFED does not assess risk to non-target insects using an RQ method. Results of 

acceptable studies are used for recommending appropriate label precautions. Direct contact and 

dietary exposure studies of honeybees indicate that clothianidin is highly toxic to honeybees 

(acute contact LD,, = 0.0439 pghee and acute oral LQ, = 0.0037 pgfbee). There is the 

potential for toxic exposure to honeybees, as well as other nontarget pollinators, through the 

translocation of clothianidin residues in nectar and pollen. In addition, studies indicate that 

clothianidin residues may affect foraging behavior. Data from studies determining the toxicity of 

residues on foliage indicate that clothianidin should not be applied to blooming, pollinating or 

nectar producing parts of plants because clothianidin will remain toxic to bees for days after a 

spray application. In honey bees, the effects of this toxic exposure may include lethal andlor sublethal effects in the larvae and reproductive effects to the queen. The field study EFED is 

reqhesting should resolve uncertainties dealing with clothianidin's affects on bees. 

Plants 

Clothianidin does not appear to present risk to terrestrial plants (seedling emergence EC,, > 0.2 

lbs ai/A; vegetative vigor EC25 > 0.2 lbs ai/A). In addition, it does not appear to present risk to 

aquatic vascular plants (Lemna gibba EC ,, > 121 ppm) or aquatic nonvascular plants 

(Selenastrum capricomutum EC,, averages 70 ppm) although EFED is still requesting aquatic 

nonvascular plant testing on four more surrogate species. The maximum peak, 21-day, and 60- 

day of modeled EECs were 1.897 to 0.870 ppb for 3 application on potato fields. This predicted 

exposure level is below levels triggering an acute risk to aquatic plants. 

Risk Description Characterization 

Clothianidin's major risk concern is to nontarget insects (that is, honey bees). EFED expects 

adverse effects to bees if clothianidin is allowed to be sprayed on blooming, pollen-shedding, or 

nectar producing parts of plants. Avian acute and chronic RQs were less than the LOCs (0.5 to 

0.1 and 1, respectively). However, the mammalian acute RQ (RQ = 0.12) for 15g mammals 

Page 26 of 1 10 
slightly exceeded the endangered species LOC of 0.1. Mammalian chronic RQs did not exceed 

LOCs for either endangered and non-endangered species. Neither endangered and nonendangered birds or mammal species are at risk from ingestion of clothianidin treated seed. It 

would seem unlikely birds or mammals would or could ingest the amount of seed needed to 

reach an LD50 dose. Clothianidin does not appear to present risk to terrestrial (there were no 

significant effects in the studies submitted), aquatic vascular or nonvascular plants. Lastly, acute 

endangered species LOCs for 15 g mammals and freshwater invertebrates were exceeded thus 

risk is possible should exposure actbally occur. However, the estimated chance of individual 

mortality following clothianidin exposure is 1 in 7.21 x loL3 for small mammals and 1 in 5.76 x 

10' for freshwater invertebrates. 

The available data on clothianidin shows that the compound is relatively persistent to very 

persistent under most circumstances. Clothianidin is stable to hydrolysis at all pH's at 

environmental temperatures, moderately to highly stable under aerobic soil metabolism 

conditions (half-lives range from 148 to 6,900 days), and shows moderate stability under 

anaerobic aquatic metabolism (half-life of 27 days for the overall system). Laboratory data 

suggests that photolysis appears to play a role in the dissipation of the chemical (half-life of 14.4 

hours in sterile water, 25.4 hours in natural water, and 34 days on soil). Clothianidin has 

medium to very high mobility in soils. The fact that the &,'s of four of the five soils were of 

similar order of magnitude (range 84 to 129) indicates that there may be a correlation of the 

mobility with the organic carbon content of the soil. Certain degradates appeared to accumulate 

in some soils under some conditions [e.g., TZNG MNG, NTG, (aerobic) and TMG (anaerobic)]; 

over the very long term significant contamination of soil and water with these products might 

occur. The terrestrial field dissipation studies confirm the findings in the laboratory studies. 

Clothianidin was found to be persistent in the field (half-lives of 277 days, 1,400 days, and too 

high to calculate). Based on the overall picture that the laboratory and field studies provided, 

EFED concluded that there is a very high likelihood that clothianidin would persist and 

accumulate from year to year after repeated uses. 

The potential impact to water quality from the use of clothianidin appears to be most likely due 

to the parent compound. The laboratory studies indicate that clothianihn is initially labile and 

then relatively persistent under most environmental conditions. This makes the chemical 

available for lengthy periods of time for runoff and exposure to aquatic environments. The 

impact of clothianidin to aquatic environments will also be affected by its mobility. The 

available studies indicated that clothianidin is persistent and mobile, stable to hydrolysis and has 

potential to leach to ground water and be transported via runoff to surface water, and will 

accumulate and persist in soils. 

Non-target aquatic organisms (freshwater and estuarinelrnarine fish and invertebrates) can be 

exposed to clothianidin by runoff or spray drift into surface water. However, EFED's risk 

assessment suggests that toxic risk to freshwater and estuarinelmarine fish and invertebrates 

appears low. Acute, restricted use, and endangered species levels of concern for fish and 

invertebrates were not exceeded for application rates and uses evaluated. However, there is the 

Page 27 of 1 10 
possibility of acute toxic risk (RQ = 0.086) to freshwater benthic invertebrates, via runoff 

especially if repeated uses occur. Because the clothianidin toxicity threshold is low for 

freshwater benthic invertebrates on an acute basis, their vulnerability represents acute potential 

risk from accumulations of clothiandin in sediments. As a dynamic trophic level, invertebrates 

add to the diversity of an aquatic system. Since clothianidin is persistent in the sediment, 

sediment toxicity testing will be needed to address the uncertainty of possible risk to the 

assemblages of benthic communities in order to determine potential impacts to aquatic systems. 

EFED's risk characterization of terrestrial animals was focused on the potential for acute and I chronic toxic risk from exposure to residual clothianidin after application. Based on proposed 

application rates and uses, acute risks to terrestrial birds and mammals is unlikely. Mammalian 

chronic RQs also did not exceed LOCs for both endangered and non-endangered species. No 

species were at risk from ingestion of clothianidin treated seed. It would seem unlikely small 

birds or mammals would or could ingest the amount of granules needed to reach an LD50 dose. 

There is uncertainty surrounding clothianidin's possible role as an endocrine disruptor as noted 

from mammalian developmental and reproductive effects. This issue is compounded by the fact 

that clothianidin is an analog of nicotine and that studies in the published literature suggest that 

nicotine, when administered, causes developmental toxicity, including functional deficits, in 

animals and/or humans that are exposed in utero. Mammalian data shows that exposure to 

clothianidin can result in developmental effects (rabbit) that include premature deliveries, 

decreased gravid uterine weights, and increase incidence of missing lung lobe in fetus. The 

mammalian data also suggests that chronic toxicity in mammals can be manifested as systemic 

effects that can include decreased body weight gains and delayed sexual maturation (males only); 

decreased absolute thymus weight in F1 pups (both sexes), and increased stillbirths (F1 and F2 

litters). Reproductive effects were also noted for adult rats that included decreased sperm motility 

and ihcreased number of sperm with detached heads. Although these effects did not reduce rat 

fecunklity, they do raise an uncertainty as to possible reproductive effects to other species that 

may have a more limited (less frequent) reproductive capability. Because small mammals may 

feed on fruit and thus, be subject to repeated or continuous exposure to the pesticide, additional 

modeling should be done to determine if mammals are at risk from repeated uses of clothianidin. 

Accumulation of clothianidin in soils as the result of multiple applications and repeated or 

continuous exposure may adversely affect soil invertebrates. Subchronic invertebrate toxicity 

studies showed that clothianidin adversely affected earthworm mortality and body weight (LC,, = 

15.5 ppm) and its degradates reduced body weight (LC,, = 982.6 ppm). Additional testing 

(chronic study) or modeling is needed to determine if soil invertebrates are at risk from repeated 

uses of clothianidin. Because small mammals may burrow in the soils, additional modeling 

should be done to determine if mammals are at risk from repeated uses of clothianidin. 

Although EFED does not conduct a risk quotient based risk assessment on non target insects, 

information from standard tests and field studies, as well as incident reports involving other 

neonicotinoids insecticides (e.g., imidacloprid) also suggest the potential for long term toxic risk 

Page 28 of 1 10 
to honey bees and other beneficial insects. Other neonicotinoid compounds like imidacloprid 

(e.g., sunflower seed treatment) have resulted in incidents to honey bees. The National Union of 

French Beekeepers had concerns regarding imidacolprid (GAUCHO) seed treatment to 

sunflowers after beekeepers noted that honey bees were showing modifications of behavior that 

were reflected in foraging and orientation that eventually resulted in a drastic change in hive 

conditions and bee survival. Further research by the Le Centre Technique Interprofessional des 

I Oleagineux (CETIOM) confirmed imidacloprid toxic residue levels in the sunflower nectar. This 

action has prompted France to ban the use of imidacloprid for sunflower seed treatment. Since 

clothianidin has a similar toxicity profile as imidacloprid and is a member of the same family of 

compounds, there is uncertainty regarding the toxic risk to honey bee development and foraging 

behavior, as well as the welfare of the queen from long term exposure to clothianidin residues 

that can be stored in the hive in honey andlor pollen. Further studies may be needed to determine 

toxicity to honeybees from granular, seed treatment or foliar spray applications. 

The uncertainties associated with clothianidin exposure in the environment are mainly focused in 

four areas; 1) accumulation of clothianidin in soils after repeated uses and the potential for 

transportfmipration to surface water bodies and potential risk to sensitive aquatic invertebrates 

(e.g., sediment-dwelling benthic organisms), 2) repeated or continuous exposure of small 

mammals and birds to the pesticide presenting a potential reproduction and developmental risk, 

3) potential toxic risk to pollinators (e.g. honeybees) as the result of accumulation of foliar spray 

on plants/blooms from repeated uses in orchards, and 4) repeated or continuous exposure to soil 

invertebrates and small mammals to clothianidin accumulated in soils after repeated uses. 

Incident Characterization 

The EPAIOPP 6(a)(2) incident reporting data base currently does not contain incident reports for 

clothianidin. However, other neonicotinoid compounds like imidacloprid have resulted in 

incidents to honey bees. The National Union of French Beekeepers had concerns regarding 

imidacloprid (GAUCHO) seed treatment to sunflowers. Beekeepers noted that bees were 

showing modifications of behavior that was reflected in foraging and orientation that eventually 

resulted in a drastic change in hive conditions and bee survival. Further research by the 

CETIOM confirmed imidacloprid toxic residue levels in the sunflower nectar. France has 

banhed the use of imidacloprid for sunflower seed treatment. This may be a concern since AE 

1283742 seed treatment contains not only clothianidin, but also imidacloprid 

Endocrine Disruption 

Data suggests that clothianidin could be a candidate for additional screening andlor testing to 

better characterize effects related to endocrine disruption. Effects in avian species included 

significant decreases in eggshell thickness. Effects in mammalian reproduction studies included 

decreased body weight gains and delayed sexual maturation (males only), decreased absolute 

thymus weight in F1 pups (both sexes), increased stillbirths (F1 and F2 litters), decreased sperm 

mobility and increased number of sperm with detatched heads (F1 and F2 litters). 

I 

I EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by 

Page 29 of 1 10 
FQPA, to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) "may have an effect in humans that is similar to an effect 

produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator 

may designate." Following the recommendations of its Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for 

including, as part of the program, the androgen- and thyroid hormone systems, in addition to the 

estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program 

include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA 

I and, to the extent that effects in wildlife may help determine whether a substance may have an 

effect in humans, m;DCA authority to require the wildlife evaluations. As the science develops 

and resources allow, screening of additional hormone systems may be added to the Endocrine I Dismptor Screening Program (EDSP). When the appropriate screening and or testing protocols 

being considered under the Agency's Endocrine Disruptor Screening Program have been 

I developed, clothianidin may be subjected to additional screening and or testing to better - 

characterize effects related to endocrine disruption. 

Threatened and Endangered Species Concerns , 

The following section dscusses the screening level assessment for Federally listed threatened 

and endangered species (listed species). 

I 

Applications 

For scenarios used to evaluate risk to aquatic organisms, the LOC (0.05) for acute effects to listed 

species of freshwater invertebrates (RQs ranged from 0.067 to 0.086) were exceeded for the 

I potato use for both single and multiple applications. 

For listed species of small mammals, clothianidin may pose slight acute (RQ = 0.12) risk of 

adverse effects, should exposure actually occur. Endangered small (15g) mammal species may 

be at risk from ingestion of clothianidin treated food items. No species were found to be at risk 

from ingesting treated seed. It would seem unlikely that small birds or mammals would or could 

ingest the amount of granules needed to reach an LD50 dose. 

Endangered insects may also be at risk due to the toxicity profile for honeybees (clothianidin is 

toxic to honeybees thus risk is assumed) should exposure actually occur. 

Listed Species 

The following table lists the number of listed species within taxonomic groups for which RQs 

exceed the listed species LOCs. Some of these listed species may not be at risk through exposure 

to clothianidin based on size, food items and habitat. The entire list of listed 

endangeredlthreatened species is given in Appendix VI. 

Page 30 of 110 
Page 31 of 110 

-- -- 
Page 32 of 110 
Page 33 of 110 
Taxonomic Groups Potentially at Risk 

For the mammalian and aquatic invertebrate species evaluated in this risk assessment, RQs 

exceeded the LOCs for endangered species for the exposure scenarios considered other than seed 

treatment. The registrant must provide information on the proximity of Federally listed 

endangered species to the use sites. This requirement may be satisfied in one of three ways: 1) 

having membership in the FIFRA Endangered Species Task Force (Pesticide Registration Notice 

2000-2); 2) citing FIFRA Endangered Species Task Force data; or 3) independently producing 

these data, provided the information is of sufficient quality to meet FIFRA requirements. The 

information will be used by the OPP Endangered Species Protection Program to develop 

recommendations to avoid adverse effects to listed species. 

UT 

VT 

VA 

WA 

wv 

WI 

WY 

TOTALS 

Action Area 

The Endangered Species Act defines the action area for a Federal action as being the footprint of 

possible effects stemming from the action, not necessarily limited to where the immediate action 

occurs. For screening-level purposes, the risk assessment conservatively assumes that listed 

species are co-located with the pesticide treatment area. This means that terrestrial plants and 

wildlife are assumed to be located on or adjacent to the treated field and aquatic organisms are 

assumed to be located in a surface water body adjacent to the treated field. This assumption 

places the listed species within an assumed area of high potential exposure to the pesticide. If 

these assumptions result in RQs that are below the listed species LOCs, a no effect conclusion is 

made. .However, in situations where the screening assumptions lead to RQs in excess of the 

listed species LOCs there a potential for may affect conclusion exists. In such cases, additional 

information on the biology of listed species, the locations of these species, and the locations of 

use sites would be considered to determine the extent to which screening assumptions apply to a 

particular listed organism. These subsequent refinement steps would consider how this 

information would impact the action area for a particular listed organism and may include 

exposures that are downwind and downstream of the pesticide use site. 

Indirect Effects Analysis 

The Agency acknowledges that pesticides have the potential to exert indirect effects upon the 

listed organisms by, for example, perturbing forage or prey availability, altering the extent of 

2 

1 

6 

4 

5 

1 

4 

59 

Page 34 of 1 10 

2 

16 10 

1 

18 

5 

2 

62 

1 

2 

39 

1 

1 

29 
nesting habitat, and creating gaps in the food chain. In conducting a screen for indirect effects, 

direct effect LOCs for each taxonomic group are used to make inferences concerning the 

potential for indirect effects upon listed species that rely upon non-endangered organisms in 

these taxonomic groups as resources critical to their life cycle. 

Because screening-level acute RQs exceed the endangered species acute LOCs, the Agency uses 

the dose response relationship from the toxicity study used for calculating the RQ to estimate the 

probability of acute effects associated with an exposure equivalent to the EEC (see Probit 

Analysis below). This information seryes as a guide to establish the need for and extent of 

additional analysis that may be performed using Services-provided "species profiles" as well as 

evaluations of the geographical and temporal nature of the exposure to ascertain if a "not likely to 

adversely affect" determination can be made. The degree to which additional analyses are 

performed is commensurate with the predicted probability of adverse effects from the 

comparison of the dose response information with the EECs. The greater the probability that 

exposures will produce effects on a taxa, the greater the concern for potential indirect effects for 

listed species dependent upon that taxa, and therefore, the more intensive the analysis on the 

potkntial listed species of concern, their locations relative to the use site, and information 

regarding the use scenario (e.g., timing, frequency, and geographical extent of pesticide 

application). 

Birds and Mammals 

Screening-level chronic RQs for birds and mammals that feed on short grass, tall grass, broadleaf 

plants and small insects, and fruits, pods, and large insects (multiple applications only for fruit 

foliar type) that exceed the LOC may indicate a potential concern for indirect effects. The 

Agency considers this to be indicative of a potential for adverse effects to those listed species that 

rely either on a specific plant species (plant species obligate) or multiple plant species (plant 

dependent) for some important aspect of their life cycle. The Agency may determine if listed 

organisms for which plants are a critical component of their resource needs are within the 

pesticide use area. This is accomplished through a comparison of Service-provided "species 

profiles" and listed species location data. If no listed organisms that are either plant species 

obligates or plant dependent reside within the pesticide use area, a no effect determination on 

listed species is made. If plant species obligate or dependent organism may reside within the 

pesticide use area, the Agency may consider temporal and geographical nature of exposure, and 

the scope of the effects data, to determine if any potential effects can be determined to not likely 

adversely affect a plant species obligate or dependent listed organism. 

Indirect effects to terrestrial animals may result from reduced food items to animals, behavior 

modifications from reduced or a modified habitat, and from alterations of habitats. Alterations of 

habitats can affect the reproductive capacity of some terrestrial animals. 

Probit Slope Analysis 

The probit slope response relationship is evaluated to calculate the chance of an individual event 

corresponding to the listed species acute LOCs. If information is unavailable to estimate a slope 

Page 35 of 110 
for a particular study, a default slope assumption of 4.5 is used as per original Agency 

assumptions of typical slope cited in Urban and Cook (1986). 

a. Terrestrial Species 

Analysis of raw data from mammalian terrestrial acute toxicity studies for clothianidin provided 

an estimate ofi slope (7.61) for females only (LD50 = 389M/465F mglkg). Based on this slope, 

the corresponding estimate chance of inlvidual mortality following clothianidin exposure is only 

1 in 7.21 x loi3 for small mammals. 

b. Aquatic Species 

Analysis of raw data from the aquatic acute toxicity studies for clothianidin estimate slopes of 

4.24 (95% C.I. 0.276 and 8.22) for freshwater invertebrates and 4.70 (95% C.I. 2.70 and 6.70) for 

estuarinelmarine invertebrates. Based on these slopes, the corresponding estimate chance of 

individual mortality following clothianidin exposure is only 1 in 5.76 x 107,for freshwater 

invertebrates and 1 in 2.1 x lo9 for estuarinelmarine invertebrates. 

Critical Habitat 

In the evaluation of pesticide effects on designated critical habitat, consideration is given to the 

physical and biological features (constituent elements) of a critical habitat identified by the U.S 

Fish and Wildlife and National Marine Fisheries Services as essential to the conservation of a 

listed species and which may require special management considerations or protection. The 

evaluation of impacts for a screening level pesticide risk assessment focuses on the biological 

features that are constituent elements and is accomplished using the screening-level taxonomic 

analysis (risk quotients, RQs) and listed species levels of concern (LOCs) that are used to 

evaluate direct and indirect effects to listed organisms. 

The screening-level risk assessment has identified potential concerns for indirect effects on listed 

species. In light of the potential for indirect effects, the next step for EPA and the Service(s) is to 

identify which listed species and critical habitat are potentially implicated. Analytically, the 

identification of such species and critical habitat can occur in either of two ways. First, the 

agencies could determine whether the action area overlaps critical habitat or the occupied range 

of any listed species. If so, EPA would examine whether the pesticide's potential impacts on 

non-endangered species would affect the listed species indirectly or directly affect a constituent 

element of the critical habitat. Alternatively, the agencies could determine which listed species 

depend on biological resources, or have constituent elements that fall into, the taxa that may be 

directly or inlrectly impacted by the pesticide. Then EPA would determine whether use of the 

pesticide overlaps the critical habitat or the occupied range of those listed species. At present, 

the information reviewed by EPA does not permit use of either analytical approach to make a 

definitive identification of species that are potentially impacted indirectly or critical habitats that 

is potentially impacted directly by the use of the pesticide. EPA and the Service(s) are working 

together to conduct the necessary analysis. 

This screening-level risk assessment for critical habitat provides a listing of potential biological 

Page 36 of 110 
features that, if they are constituent elements of one or more critical habitats, would be of 

potential concern. These correspond to the taxa identified above as being of potential concern 

for indirect effects and include small and medium sized mammals. This list should serve as an 

initial step intproblem formulation for further assessment of critical habitat impacts outlined 

above, should additional work be necessary. 

Possible Risk Refinement Measures \ 

Source control measures such as reduction in the application rate, reduction in the number of 

applications (especially in the presence of pollinators or nesting birds), and increasing the 

interval between applications may be implemented for clothianidin as possible risk reduction 

measures. 

In order to fully evaluate the possibility of chronic exposure to honey bees with subsequent , 

impacts to pollination, a complete worker bee life cycle study has been'required as well as an 

evaluation of exposure and effects to the queen. 

Additional modeling should be done to simulate the potential affects of repeated uses in order to 

determine if reproduction and development are affected in birds and mammals by chronic 

exposure. 

Additional modeling or toxicity testing should be done to determine if repeated uses may present 

a risk to soil invertebrates and burrowing mammals. 

Sediment toxicity testing of sensitive species (i.e. burrowing mayflies) would provide data to 

address the uncertainty of possible risk to invertebrates that inhabit or come into contact with 

sediment receiving surface water runoff or drift from treated fields. An OPPTS 850.1735 

(Whole Sediment Acute Toxicity Invertebrates, Freshwater) toxicity test would also provide data 

concerning the potential chronic effects to benthic organisms because clothianidin persists in the 

environment representing a continual source as an environlmental sink. This is a 28 day test that 

measures survival, growth and emergence of Chironomus riparius that have been exposed to 

pesticide spiked sedment. 

Since clothianidin may serve as an environmental sink in aquatic sediments, additional 

information is needed to address potential effects of repeated uses. Aquatic field studies should 

be performed to determine system-wide effects to the assemblages of organisms in aquatic 

communities. 

Page 37 of 110 
Appendix I. Summary of Individual Environmental Fate Studies 

161 -1 Hydrolysis (MRID 454223 17) 

[~hiazolyl-14C]clothianidin did not significantly hydrolyze in sterile pH 5,7 and 9 buffer 

solutions at 25°C; 294% of the applied was undegraded at 33 days (study termination; MRID 

45422317). Clothianidin did degrade quickly in pH 9 buffer solutions at 62°C and 74"C, with 

half-lives of 3.7 and 0.7 days, respectively. At pH 9 and the elevated temperatures, two 

significant degradates were formed. At 62"C, 2-chlorothiazol-5-ylmethylamine (ACT) and N-(2- 

chlorothiazol-5-ylmethy1)-N'-methylurea (TZMU) reached a maximum concentration of 53.6% 

and 14.7% of applied, respectively, at 7 days posttreatment. At 74"C, ACT and TZMU reached 

maximum concentrations of 59.2% and 22:6% of applied, respectively, at 1.9 days posttreatment. 

161-2 Photolysis in Water (MRIDs: 454223 18,454223 19,45422320,45422321,45422322) 

Nitroimino- and thiazolyl- [14C]clothianidin photodegraded rapidly in sterile pH 7 buffer solution 

at 25°C under continuous irradiation; half-lives were 3.4 and 3.1 hours, respectively (MRIDs 

454223-18,20,22). Less than 1% of the clothianidm remained undegraded after 24 hours of 

irradiation. No significant degradation occurred in the dark controls. The predicted 

environmental half-life was 14.4 hours (extrapolating from the actual study conditions assuming 

mid-summer sunny conditions in Phoenix, Arizona; based on continuous irradiation; 5.76 hours 

of irradiation were equivalent to 1 day of clear midday midsummer sunlight). 

[~itroimino-14C]clothianidin degraded mainly to methylguanidine (MG), TZMU, 4-hydroxy-2- 

methylamino-2-imidazolin-5-one (HMIO) and methylurea (MU), with maximum concentrations 

of 34.7% (432 hours), 29.3% (24 hours), 26.6% (24 hours), and 11.0% (432 hours) of the 

applied, respectively. [Thiazolyl-14C]clothianidin degraded mainly to TZMU, forrnamide (FA), 

7-methylamino-4H-imidazol[5,1 -b] [I ,2,5]thiadiazin-4-one (MIT), and CO,, with maximum 

concentrations of 39.7% (24 hours), 16.1 % (120 hours), 11.8% (24 hours), and 34.1 % (432 

hours) of the applied, respectively. In nonsterile river water (pH 7.0-9.6) under sunlight, 

nitroimino- and thiazolyl-[14C]clothianidin degraded with half-lives of 25.1 and 27.7 hours, 

respectively (MRIDs 454223-19, -21 ). Temperatures averaged approximately 25°C (range 21.5 

to 31.3OC) and average daylight was 8.7 hours (range 0.7 to 14.4 hours). Clothianidn was ~5% 

of the applied at and after 4 days posttreatment. No significant degradation occurred in the dark 

controls. This study suggests a longer transformation period than the sterile buffer study; 

however, variable conditions (temperature, pH, sunlight) make precise comparisons difficult. 

In the river water, [nitroimino-14C]clothianidin degraded mainly to MG, HMIO, and MU with 

maximum concentrations of 46.5% (696 hours), 28.0% (120 hours), and 12.0% (432 hours) of 

the applied, respectively. [~hiazolyl-14C]clothianidin degraded mainly to CO,, with a maximum 

concentrations of 28.5% (696 hours) of the applied; other major degradates were Urea, N-(2- 

clorothiazol-5-ylmethy1)-N'-methyguanidine (TMG), 3-methylamino-1H-imidazo [I ,5- 

climidazole (MAI), and 2-chlorothiazol-5-lymethanol (CTCA) with maximum concentrations of 

18.1% (264 hours), 17.2% (120 hours), 13.6% (120 hours), and 13.3% (432 hours) of the 

Page 38 of 110 
applied, respectively. 

161-3 Photodegradation on Soil (MRID: 45422323) 

Clothianidin degraded with a half-life of 8.2 days in a sandy loam soil at 20°C, based on 

continuous irradiation; 5.76 hours of irradiation were equivalent to 1 day of clear midday 

midsummer sunlight at 40°N latitude (MRID 45422323). The equivalent environmental half-life 

calculated assuming 5.76 hours under study conditions equals one day under natural summer 

sunlight is 34 days. At study termination (17 days), 22.3% of the clothianidin remained 

undegraded. No significant degradation occurred in the dark controls. No degradates 

accumulated to significant levels during the study. 

16 1-4 Photodegradation in Air (Waived) 

162-1 Aerobic Soil Metabolism (MRIDs 45422325,45422326) 

Clothianidin degraded in two soils with a half-life of 148 and 239 days, in seven soils ranging in 

texture from sand to silt loam with half-lives of 495 to 1,155 days, and in a tenth soil (loamy 

sand, 0.35% OC) with a half-life of 6,932 days (MRDs 45422325 and 45422326). In all cases, 

the data were extrapolated beyond the duration of the study and assumed that decay would 

continue at a first order rate. 

All of the soils were studied at 20°C with a moisture content of 75% of 113 bar except for the 

Laacher Hof silt loam and Hofchen silt soils from Germany, which were studied at a moisture 

content of 40% of maximum water holding capacity. Since all studies were conducted at 20°C, 

clothianidin might have been less persistent than if the studies had been conducted at 25OC, the 

temperature of most laboratory soil metabolism studies. The Hofchen, Laacher Hof, and BBA 2.2 

soils were treated with [nitroimido-14C]clothianidin. The remaining soils were treated with 

[thiazolyl-14C]clothianidin. 

Page 39 of 110 

jummary of aerobic soil metabolism study for clothianidin, presented in order of ascending halfives. 

Soil 

Hofchen silt from Germany 

(MRID 45422325) 

Laacher Hof (AII) silt loam 

from Germany 

(MRID 45422325) 

Loamy sand (BBA 2.2) 

from Germany 

(MRID 45422325) 

Quincy loamy sand 

(MRID 45422326) 

% OC 

2.66 

0.86 

2.5 

0.4 

pH in water 

10.01 M CaC12 

7.817.2 

8.117.3 

6.016.3 

6.81--- 

% Remaining at end of 

study 

54.3% at 120 days 

68.6% at 120 days 

57.8% at 365 days 

80.8% at 181 days 

Extrapolated halflife, days 

148 

239 

495 

533 
Residue analvsis. Residues were analyzed using thin-layer chromatography (TLC) in multiple 

solvent systems and radiographic imaging. In MRID 45422325, clothianidin and four nonvolatile 

degradates [&methyl-N'-nitroguanidine (MNG); nitroguanidine (NTG); N-(2-chlorothiazol-5- 

ylmethy1)-N'-nitroguanidine (TZNG); and N-(2-chlorothiazol-5-ylmethy1)-w-methylurea (TZMU)] 

were identified by comparison to reference standards. In MRID 45422326, clothianidin, TZNG, 

and TZMU were identified by comparison to reference standards and LCIMS. There were no 

unidentified extractable degradation products. 

Soil 

Sparta sand 

(MRID 45422326) 

Crosby silt loam 

(MRID 45422326) 

Susan silt loam 

(MRID 45422326) 

Howe sandy loam . (MRID 45422325) 

Elder loam 

(MRID 45422326) 

Fuguay loamy sand 

(MRID 45422326) 

MNG, a degradate originating from the nitroimino moiety, was a maximum 0.7 and 9.5% of the 

applied in the Laacher Hof and Hofchen soils and 5.9% in the BBA 2.2 soils (MRID 45422325). 

The maximum concentrations were measured either at the final sampling interval or, if measured 

prior to the final interval, showed no pattern of decline through study termination. In sandy loam 

and silt loam Laacher Hof soils and the Hofchen silt soil at 20°C and 50% of maximum water 

holding capacity, MNG degraded with half-lives of 65-1 16 days (MRID 45422327). 

NTG, a degradate originating from the nitroirnino moiety, was a maximum 3.7-6.7% of the applied; 

in all three soils the maximum was measured at the final sampling interval (MRID 45422325). 

TZNG was a maximum 5.1-9.1 % of the applied in the Laacher Hof, Hofchen, and BBA 2.2 soils 

and 2.5% in the Howe sandy loam soil at the final sampling interval (MRID 45422325). In all other 

soils, the maximum was 50.5% of the applied (MRID 45422326). In sandy loam and silt loam 

Laacher Hof soils and the Hofchen silt soil at 20°C and 50% of maximum water holding capacity, 

TZNG degraded with half-lives of 53-122 days (MRID 45422328). 

% OC 

0.73 

1.37 

3.27 

1.12 

1.41 

0.35 

TZMU was <2.4% of the applied in all soils (MRIDs 45422325 and 45422326). 

The maximum concentrations of MNG and TZNG in the soils are probably limited by the relatively 

pH in water 

10.01 M CaCl2 

6.2215.3 1 

6.7416.01 

6.6615.91 

6.716.7 

6.6715.84 

6.6715.84 

Page 40 of 1 10 

% Remaining at end of 

study 

79.5% at 181 days 

60.3% at 379 days 

78.3% at 181 days 

75.8% at 365 days 

87.5% at 181 days 

95.3% at 181 days 

Extrapolated halflife, days 

533 

578 

693 

990 

1155 

6932 
rapid rate of degradation of these compounds compared to the slower rate of degradation of 

clothianidin. No additional information was submitted on the rate of degradation of NTG, so it is 

not certain if significant additional accumulation would occur. TZMU is most likely a minor 

degradate under all conditions. 

CO, was a major transformation product in soils in several soils in which significant degradation 

occurred prior to study termination (MRIDs 45422325 and 45422326). 

162-2 Anaerobic Soil Metabolism 

No anaerobic soil metabolism study has been conducted; however, an anaerobic aquatic soil 

metabolism study was conducted in lieu of this study. 

162-3 Anaerobic Aquatic Metabolism (MRID: 45422330) 

Clothianidin degraded in with half-lives of 14 days in the water phase, 37 days in the sediment 

phase, and 27 days overall in an anaerobic water:silt loam sediment (3:1, v:w) system at 20°C 

(MRID 45422330). Clothianidin was <1% of the applied in the water phase at and after 120 days 

and was ~2.0% in the sediment at and after 183 days. No major degradates were isolated and no 

minor degradates were identified, in large part because the majority of the residues were not 

extracted from the sediment at later sampling intervals despite the use of more harsh extraction 

procedures. 

162-4 Aerobic Aquatic Metabolism (MRIDs: 45422324 and 45422329) 

No acceptable aerobic aquatic metabolism studies have been conducted. Although two studies were 

1 submitted by the registrant under this guideline, the experimental designs of both were inadequate 

to define the pattern of decline of clothianidin under aerobic aquatic conditions (MRIDs 45422324 

I and 45422329). The experimental design was not in compliance with guidelines (soil and water 

were pre-incubated before applying the test substance) and aerobic conditions were not fully 

maintained during the course of the study as indicated by the low redox potential that developed in 

the sediment 

163-1 Mobility, AdsorptionIDesorption Batch Equilibrium (MRIDs: 4542231 1 and 45422312) 

Clothianidin has medium to very high mobility in soils ranging from sand to clay loam, with 

Freundlich adsorption coefficients ranging between 0.52 and 4.14 (MRID 454223 11). Soil organic 

carbon partition coefficients (kc) values were 84 to 129 for all test soils except the US sandy loam 

soil, which had a KO, value of 345. For all five test soils, Freundlich desorption coefficients and soil 

desorption carbon coefficients were slightly higher than those obtained for adsorption. 

Page 41 of 110 

Freundlich adsorption and desorption constants of clothianidin in the soils. 

Soil 

Quincy loamy sand 

BBA 2.1 sand 

Adsorption 

K, 

0.52 

0.59 

Desorption 

K, 

0.62 

0.85 

lln 

0.8351 

0.8648 

lln 

0.8068 

0.8843 

r2 

0.9952 

0.9974 

Kw 

129 

119 

r2 

0.9982 

0.9966 

I&c 

154 

170 
I 

In addition, the desorption of aged clothianidin was studed using Laacher Hof AXXa sandy loam 

and Laacher Hof AID silt loam soils from Germany, adjusted to 40% of the maximum water 

holding capacity, dosed at 0.13 or 1.35 mg a.i./kg, and incubated at 20 2 1°C for up to 99 days 

(MRID 45422312). After aging, the soils were equilibrated for 24 hours. Clothianidn 

I comprised approximately 57% of the applied in the soil at 99 days. Clothianidin has low to 

moderate mobility in the soils after aging. Freundlich desorption coefficients and soil organic 

carbon partition coefficients (Koc) increased over time in the low-dose soils. 

Soil 

Crosby clay loam 

Laacher Hof sandy 

loam 

Elder sandy loam 

7reundlich desorption constants of clothianidin in the low-dose soils. 

Similar results were observed in the high-dose soils aged for 99 days. Freundlich adsorption 

coefficients increased from 1.56 to 3.30 for the sandy loam soil and from 0.96 to 3.05 for the silt 

loam soil after 99 days; corresponding increases in soil organic partition coefficients were 153 to 

323 and 98 to 3 11. The study author attributed the increasing Koc values to changes in the sorption 

process, leading to stronger adsorption to soil and diffusion processes into less accessible sorption 

sites. 

Adsorption 

Soil 

Sandy loam 

163-1 Mobility of the transformation products of clothianidin (MRIDs: 45422313,454223 14, 

454223 15, 454223 16) 

The mobility of four clothianidjn degradates (MNG, TZMU, TZNG, and TMG) was also studied in 

three US and two German soils using batch equilibrium experiments. The mobilities of the 

degradates varied from very highly mobile to immobile. MNG had very high mobility in the five 

test soils, with Freundlich adsorption coefficients between 0.0199 and 0.3736, and soil organic 

Desorption 

Kd 

Koc 

Page 42 of 1 10 

Kd 

1.67 

1.99 

4.58 

Kd 

1.48 

1.77 

4.14 

Days of Aging Prior to Desorption 7 

r2 

0.9992 

0.9998 

0.9997 

l/n 

0.8216 

0.8146 

0.8088 . 

0 

2.09 

205 

K, 

123 

84 

345 

l/n 

0.8240 

0.8136 

0.8115 

Silt loam 

2 

2.51 

246 

rZ 

0.9987 

0.9981 

0.9987 

Kd 

KO, 

KO, 

139 

95 

382 

7 

3.99 

39 1 

2.37 

242 

1.17 

120 

14 27 

3.26 

319 

1.40 

143 

2.01 

205 

55 

3.65 

357 

3.34 

34 1 

2.23 

228 

99 

4.05 

413 

4.86 

477 

5.94 

582 
carbon partition coefficients ranging from 5.2 to 34.3 (MRID 45422313). TZMU had high to very 

high mobility, with Freundlich adsorption coefficients ranging between 0.1764 and 1.0445, and 

corresponding soil organic carbon partition coefficients between 46.4 and 95.8 (MRID 454223 15). 

TZNG was moderately mobile in the test soils, with Freundlich adsorption coefficients ranging 

between 0.6274 and 4.7 137 and corresponding soil organic carbon partition coefficients between 

204.5 to 432.5 (MRID 454223 14). TMG was immobile or had low mobility in the test soils; 

Freundlich adsorption coefficients were between 2.4381 and 39.4584 and corresponding soil 

organic carbon partition coefficients were 525.0 to 6159.4 (MRID 454223 16). Freundlich 

desorption coefficients and soil organic carbon partition coefficients (when calculated) for the four 

degradates were higher than those obtained for adsorption, except were lower for MNG in the US 

silt loam soil. 

Page 43 of 110 

Freundlich adsorption and desorption constants of clothianidin degradates MNG, TZMU, TZNG, 

and TMG in three US and two German soils. 

Soil 

Adsorption 

MNG 

Kd l/n r2 

Desorption 

Quincy sand 

BBA 2.1 sand 

Crosby silt loam 

Laacher Hof AIIa 

sandy loam 

Elder sandy loam 

KO, K, I l/n r2 KO, 

0.0514 

0.0199 

0.1928 

0.2584 

0.3736 

TZMU 

1.1012 

0.7017 

0.9249 

0.9005 

0.9083 

Quincy sand 

BBA 2.1 sand 

Crosby silt loam 

Laacher Hof AIIa 

sandy loam 

Elder sandy loam 

0.1280 

0.1764 

0.6547 

0.5867 

1.0445 

0.9726 

0.8920 

0.9983 

0.9999 

0.9988 

TZNG 

21.4 

5.2 

16.5 

25.3 

34.3 

Not calculated 

Not calculated due to low adsorption 

0.9276 

0.8695 

0.8645 

0.8804 

0.8430 

0.1520 

0.3561 

0.4795 

Quincy sand 

BBA 2.1 sand 

Crosby silt loam 

Laacher Hof 

AXXa sandy loam 

0.6274 

0.7772 

2.8387 

2.4072 

0.9010 

0.8059' 

0.8070 

0.8003 

0.8764 

0.8907 

0.9697 

0.9999 

0.9999 

0.9999 

0.9996 

0.9996 

53.3 

46.4 

56.0 

57.5 

95.8 

0.1511 

0.2604 

0.8329 

0.7832 

1.3390 

0.9963 

0.9994 

0.9999 

0.9999 

0.9812 

0.9998 

0.9993 

13.0 

34.9 

44.0 

0.8463 

0.8659 

0.8716 

0.8781 

0.8554 

261.4 

204.5 

242.6 

236.0 

0.9995 

0.9999 

1.0000 

0.9996 

0.9998 

0.8309 

1.0290 

3.2321 

2.8622 

63.0 

68.5 

71.2 

76.8 

122.8 

0.8975 

0.7923 

0.8059 

0.7924 

0.9958 

0.9988 

0.9999 

0:9999 

346.2 

270.8 

276.2 

280.6 
Soil 

Elder sandy loam 

Quincy sand 

BBA 2.1 sand 

Crosby silt loam 

Laacher Hof AIIa 

sandy loam 

Elder sandy loam 

I 

I Adsorption ! Desorption 

163-2 Laboratory Volatility 

Data waived due to low vapor pressure. 

163-3 Field Volatility 

Data waived due to low vapor pressure. 

164-1 Terrestrial Field Dissipation (MRIDs: 45422332,45422333,45422334,45422335, 

45422336,45490703,45490704,45490705) 

TI2435 FS 600 Terrestrial field dissipation. Terrestrial field dissipation studies of clothianidin 

applied to bare soil have been submitted from Wisconsin (MRID 45422332), Ohio (MRID 

45422333), North Dakota (MRID 45422334), Ontario (MRID 45422335) and Saskatchewan 

(MRID 45422336). Clothianidin was applied as a broadcast spray using the test formulation (a 

seed treatment for corn and canola seeds) in all five studies. The application rate in the field 

studies was 243 or 660 g a.i/ha, approximately two and six times the maximum proposed label 

rate (corn; 1.5 mglseed, equivalent to 122 g a.i./ha). 

Half-lives of clothianidin, based on residues in the 0-15 cm soil depth, ranged from 277 days 

(Wisconsin test site, sand soil) to 1,386 days (North Dakota test site, clay loam soil); a half-life 

could not be determined for the Saskatchewan (clay loam soil) test site due to limited dissipation 

during the study. DT90 values ranged from 980 days to 2,780 days and could not be determined 

for the Saskatchewan test site. No degradates were detected at >lo% of the applied, with the 

exception of a single detection of TZMU at 10.1 % of the applied the Ohio test site. Clothianidin 

was generally not detected below the 45 cm soil depth, except in the Wisconsin sand soil at a 

maximum depth of 45-60 cm. Degradates were generally onlyxetected in the 0-15 cm soil layer. 

Page 44 of 110 
Reviewer-calculated, based on residues in the 0-15 cm soil layer. 

Registrant-calculated, based on residues in all soil layers. 

Excludes outlier at 842 days posttreatment (TI-435 detected at 0.146 mglkg, mean of three replicates). ' Two trials were conducted at the Saskatchewan test site. 

Day 0 (post-incorporated values). The maximum concentration of TI-435 observed in trials 1 and 2 occurred at 61 days (0.122 mgkg) and 678 days (0.0916 

mglkg), respective1 y. 

' A half-life could not be determined at the Saskatchewan test site due to limited dissipation during the study. 

Dissipation of clothianidin in five field studies following a single application of TI-435 FS 600 to bare soil. 

Page 45 of 1 10 

, 

' Concentration in the 0-15 cm soil layer. 

Geographic 

location 

Wisconsin, USA 

- 

Ohio, USA 

North Dakota, 

USA 

Ontario, Canada 

Saskatchewan, 

Canada5 

Soil texture 

(0-15 cm) 

Sand 

Silt loam 

Clay loam 

Silt loam 

Silty clay loam 

Application 

rate (target) 

660 g a.i./ha 

660 g a.i./ha 

243 g a.i./ha 

660 g a.i./ha 

243 g a.i./ha 

Incorporated 

Yes, depth not 

reported 

No 

No 

Yes, 5 cm 

Yes, 5 cm 

Time to maximum 

conc.' 

0.319 mglkg (7 days) 

0.235 mgkg (7 days) 

0.124 mgkg (15 days)4 

0.278 mgkg (7 days) 

0.08 11-0.0985 mgkg 

(day w6 

Conc. at study 

termination1 

0.030 mgkg (823 

days) 

0.0305 mgkg (735 

days) 

0.0353 mglkg (864 

days) 

0.0576 mgkg (798 

days) 

0.0638-0.0796 

mglkg (775 days) 

Half-life2 

277 days 

(r2 = 0.80) 

315 days 

(r2 = 0.85) 

1,386 

(r2 = 0.10) 

365 days 

(r2 = 0.5 1) 

Could not be 

determined7 

DT903 

1,330 days 

980 days 

2,780 days 

1,160 days 

Could not be 

determined7 
TI-435 5OWDG Terrestrial field dissipation. Terrestrial field dissipation studies of clothianidln 

(TI-435 5OWDG) applied to bare soil have been submitted from California (MRID 45490703), 

Washington (MRID 45490704) and Georgia (MRID 45490705). Clothianidin was applied as a 

broadcast spray using the test formulation TI-435 5OWDG in all three studies. The application 

rate in the field studies was 229 g a.i/ha. The label application rate was not provided. 

Cothianidon concentrations in the California study varied widely with no pattern of decline; 

sequently, it was not possible to calculate half-lives or DT90. In the other studies half-lives of 

clothianidin, based on residues in the 0-15 cm soil depth, ranged from 257 days for the 

Washington study to 990 days for the Georgia test site. However, due to the extreme variability 

of the data for the Georgia study the calculated half-life is deemed to have limited value by the 

reviewer. DT90 values ranged from 686 days (Washington) to 3070 days (Georgia). No 

degradates were detected at >lo% of the applied. 

Page 46 of 1 10 
~f TI-435 50 WDG to bare soil. 

IlGeographic I Soil-texture (~""lication I Tn~nrnnraterl I 1 

I Not calculable 1 

Dissipation of clothianidin in three field studies following a single application ( 

1 I 

- -----A r--..w.. rime to maximum 1 (0-15 cm) ( rate (target) ( c0nc.l 

California, USA 

Washington, 

USA 

Georgia, USA 

Conc. at study 

termination1 

Loadsandy loam 

Loamlsandy loam 

Sandy loadsandy 

Half-life2 

clay loam 

DT903 

225 g a.i.ka 

225 g a.i./ha 

225 g a.i./ha 

Concentration in the 0-15 cm soil layer. 2 Reviewer-calculated, based on residues in the 0-15 cm soil layer. 

3 Registrant-calculated, based on residues in all soil layers. 

Excludes outlier at 365 days posttreatment, reviewer considers half-life calculation of limited value due to variability of data. 

(739 days) 

No 

No 

No 

(r2= 0.15) 

96.8 pglkg (day 0) 

129' pglkg (day 0) 

82.6 pglkg (365 days) 

78.1 pglkg 

(982 days) 

12.6 pglkg 

(623 days) 

23.9 pglkg 

Not calculable 

257 days 

(r2= 0.43) 

9904 days 

686 days 

30704 days 
In lysimeter studies conducted in the Federal Republic of Germany (FRG), clothianidin was 

applied to the same sandy loam soil (0-10 cm depth: 70.8% sand, 20.7% silt, 8.6% clay, pH 7.2, 

1.8% organic carbon; Appendix 5, p. 45) in Monheim, FRG. In the first study, [nitroimino14C]clothianidin, formulated as TI-435 200 SC, was applied twice (10 months apart) at 

approximately 160 g a.i./ha/application to an enclosed plot (1 m2 x 1.3 m depth) of sandy loam 

soil planted with turf (MRID 45422508). In the second study, [Thiazolyl-14C]clothianidin, 

formulated as TI-435 70 WS, was applied twice (400 days apart) as a seed treatment at 

approximately 100 g a.i./ha and 138 g a.i./ha, respectively, to an enclosed plot (1 m2 x 1.3 m 

depth) of sandy loam soil (MRID 45422331). 

In the MRID 45422508 study, approximately three years following the first application, 42-45% 

of the applied was detected in the soil and approximately 1% was detected in the leachate; the 

loss of radioactivity, approximately 54-56%, was attributed to mineralization of clothianidin. 

Grass clippings were not analyzed separately. Approximately 39.5-40.4% of the applied was 

detected within the top 0-30 cm of soil, with clothianidin accounting for the majority of the 

extracted radioactivity (maximum of 18.02 pglkg soil in the 0-10 cm soil layer). The degradates 

MNG, TZNG and NTG were detected at maximum concentrations of 1.57 pglkg soil, 3.05 /@kg 

soil and 0.77 pglkg soil, respectively, in the 10 cm soil layer. MNG and NTG were also detected 

in the leachate samples; clothianidin was not detected in any leachate samples. 

In the MRlD 4542233 1 study, winter barley seeds were treated and sown for the first application 

and winter wheat seeds were treated and sown for the second application; the lysimeter was 

cropped with untreated winter wheat during the third year of the study. Approximately three 

years following the first application, 59% of the applied was detected in the soil, 3% was 

detected in the harvested crops and 0.3% was detected in the leachate; the loss of radioactivity, 

approximately 37%, was attributed to mineralization of clothianidin. Approximately 57% of the 

applied was detected within the top 0-30 cm of soil, with clothianidin accounting for the majority 

of the extracted radioactivity (maximum of 25.4 pglkg soil in the 0-10 cm soil layer). The only 

degradate detected was TZNG, at a maximum concentration of 5.21 pglkg soil in the 10 cm soil 

layer. Clothianidin and TZNG were detected in the harvested crops, with the majority of the 

radioactivity being detected in the hulls/straw and chaff. Four unknown degradates were 

detected in the leachate samples; clothianidin was not detected in any leachate samples. 

Ancillary studies - The extraction efficiency of two analytical methods to determine clothianidin 

and its degradates TZNG, MNG, TZMU and TNG was compared in two aged German soils 

(MRID 45422604). Radiolabeled test substances were applied to the two soils (a sandy loam and 

a silt loam) at a concentration equivalent to 300 g a.i./ha and maintained in the dark at 20 -+ 1 OC 

and at 75% of 1/3 bar moisture under static aerobic conditions for 92 days. For the "lab 

method", 100 g soil samples were extracted four times with acetonitrile and once with water by 

shaking; following centrifugation, extracts were filtered and analyzed by TLC. For the "field 

method", 20 g soil samples were mixed with 4 g hydromatrix and extracted using an Accelerated 

Solvent Extractor with acetonitri1e:water:acetic acid:guanidine hydrochloride (200:800:0.8:8, 

v:v:v:w) at a temperature of 140°C and a pressure of 140 bar; extracts were analyzed by TLC. 

Page 48 of 110 
Both total radioactive residues extracted and extraction efficiencies for each individual test 

substance were generally greater with the field method as compared to the lab method. The study 

author speculated that the lower recoveries for the lab method may have been a result of the 

higher metabolism/mineralization capacity of the 100 g soil samples used in the lab method as 

compared to the 20 g soil samples used in the field method; however, neither bound residues nor 

CO, were measured. 

In a storage stability study, no significant degradation of clothianidin and the degradates TZNG, 

TZMU, TMG, and MNG was observed in frozen samples of Howe soil fortified with parent and 

degradates at approximately 50 pgkg and stored frozen for 12 months at temperatures between -18 

and -25°C (MRID 45422612). Following storage, clothianidin and the degradates were extracted 

from soil with acetonitri1e:water:acetic acid:guanidine hydrochloride (200:800:0.8:8, v:v:v:w) using 

an Accelerated Solvent Extractor (ASE). After extraction, an internal standard solution was added 

and the volume adjusted with acetonitri1e:water (1:4, v:v). Extracts were analyzed by LC-MSIMS. 

Isotopically labeled internal standards (d3-TI-435; 13C, 15N-TZNG; d3-TZMU; d3-MNG and d3- 

TMG) were used to compensate for possible matrix effects in the MSIMS detector. Mean 

recoveries of TI-435 were 106% at day 0,98.4% at 118 days, 96.1% at 180 days, and 91.2% 

following 356 days of storage. Mean recoveries of TZNG were 94.6% at day 0, 101% at 118 days, 

98.6% at 180 days, and 92.4% following 356 days of storage. Mean recoveries of TZMU were 

104% at day 0 and 118 days, 95.6% at 180 days, and 93.7% following 356 days of storage. Mean 

recoveries of TMG were 95.6% at day 0, 82.3% at 118 days, 94.4% at 180 days, and 83.4% 

following 356 days of storage. Mean recoveries of MNG were 95.7% at day 0,96.1% at 118 days, 

110% at 180 days, and 101% following 356 days of storage. The study "is still running for at least 

one more year." 

164-2 Aquatic Field Dissipation 

Reserved. 

Soil 

Sandy loam 

TI-435 

. TZNG 

MNG 

TZMU 

TMG 

Silt loam 

TI-435 

TZNG 

MNG 

TZMU 

TMG 

Page 49 of 110 

Field method 

Total extracted 14C 

102.9 

90.1 

90.4 

61.0 

83.5 

109.4 

89.5 

79.5 

34.6 

84.6 

Lab method 

Total identified 14C 

82.2 

69.9 

66.8 

41.6 

78.9 

81.9 

61.4 

49.0 

20.8 

80.7 

Total extracted 14C 

105.3 

89.3 

89.4 

35.8 

73.3 

100.2 

85.1 

86.6 

20.9 

64.3 

Total identified 14C 

76.5 

52.4 

56.0 

20.2 

62.1 

70.3 

50.1 

44.4 

13.4 

58.2 
I 165-4 Bioaccumulation in Fish (waived) 

This data requirement has been waived. Octanol/water partitioning (Kow) data provided in an 

aerobic aquatic metabolism study indicates a low potential for clothianidin to accumulate (Kow for 

clothianidin = 1.12 at pH 7; MRID 45422329). 

165-5 Accumulation - Aquatic Non-target Organisms 

Reserved. 

166-1 Groundwater - Small Prospective 

The study was requested and is required. 

20 1 - 1 Droplet Size Spectrum (MRIDs: 4549070 1) 

A single droplet size spectrum study has been complete which has been classified as supplemental 

(upgradedable). It was considered to be scientifically valid, but cannot be used to fulfill the 

requirement for an atomization droplet size spectra because the test substance/solution was not 

adequately characterized. The atomization droplet size spectra of (E)-N-[(2-~hloro-5- 

thiazolyl)methyl]-N'-methyl-N"-nitroguanidine (clothianidin; TI-435 50 WDG) was studied by 

spraying the test substance mixed with water and oil (0.25% v:v) under controlled conditions at a 

rate of 90 g a.i./acre in spray mixture volumes of 150 and 300 gallons/acre. Spray conditions were 

simulated through four disk-core nozzle types, D14-25, D10-25, D6-25 and D3-46 (0" nozzle 

orientation, straight back from the wind tunnel airstream), in combination with wind tunnel 

airstream velocities of 74 and 136 mph. Liquid pressure at the nozzle tips was either 150 psi 

(treatments 1-16) or 100 psi (treatments 17-24). 

For application methods at a liquid pressure of 150 psi (airstream velocities of 74 and 136 mph, rate 

150 and 300 gallons/acre), the mean D,,, ranged from 161-274 pm. At a liquid pressure of 100 psi, 

D,,, ranged from 185-343 pm. 

Although no statistical analysis was reported, there was good agreement in atomization data 

between replicates of each treatment. The sprays became finer in the following nozzle order: D3-46 

(coarsest)> D14-25> D10-25> D6-25 (finest). Sprays were also slightly coarser at the greater. 

dilution rate (300 gallons/acre). The study author proposed that likely resulted from the higher 

dynamic surface tension expected with the more dilute tank mix. 

Sprays were much finer with at the higher airstream velocity due to greater air shear, with the 

exception of the D3-46 nozzle, which was only slightly finer at the higher velocity. Higher pressure 

(150 psi) at the nozzle tips also produced a finer spray. The effect of the application volume rate 

dilution on atomization was much lower than effects of nozzle size, airstream velocity and spray 

pressure. 

The sprays were classified as fine to medium (V < 141pm) according to the British Crop Protection 

Council (BCPC) and American Society of Agricultural Engineers (ASAE) spray quality 

classification scheme for droplet size categories. 

202- 1 Drift Field Evaluation 

Page 50 of 1 10 
Reserved. 

Appendix 11. Ecological Toxicity Data Summaries 

Toxicity to Terrestrial Animals 

Page 51 of 110 
Birds, Acute and Subacute 

An oral toxicity study using the technical grade of the active ingredient (TGAI) is required to 

establish the acute toxicity of clothianidin to birds. The preferred guideline test species is either 

mallard duck (a waterfowl) or bobwhite quail (an upland gamebird). The data that were 

submitted show that the 14-day oral LD,, is >2,000 mgkg for bobwhite quail. The NOAEL is 

500 mg/kg with observed effects including reduced mean body weights, mortality and clinical 

effects (subdued birds) in the 1,000 and 2,000 mgkg test groups. A study conducted on a nonguideline species, Japanese quail, showed that the 14-day oral LD,, is 423 mg/kg. The NOAEL 

is 12,5 mg/kg bw based on clinical signs of toxicity (lethargy and ruffled appearanced) at the 25 

mg/kg treatment level. Based on these results, clothianidin is categorized as ranging from 

practically non-toxic to moderately toxic to avian species on an acute oral basis; the guideline 

(7 1- 1) is fulfilled (MRID #45422417). 

Avian Acute Oral Toxicity 

Species % ai LD50 Toxicity MRLD No. Study 

0w.k) Category Author, Year Classification 

Northern bobwhite quail 96.0 >2,000 Practically non- 45422417 Core 

(Colinus virginianus) toxic Johnson, 1998 

Japanese Quail 97.6 423 Moderately toxic 454224 18 Supplemental 

(Coturnix coturnix Gallagher et 

j aponica) al., 2000 

Two dietary studies using the TGAI are required to establish the subacute toxicity of clothianidin 

to birds. The preferred test species are mallard duck and bobwhite quail. The data that were 

submitted show that the 8-day acute dietary LC,, is >5,000 ppm; therefore, clothianidin is 

categorized as practically non-toxic to avian species on a subacute dietary basis. The 8-day 

NOAEC's for each species based on sublethal effects (reduced body weight gain) were 309 ppm 

for the quail and 646 ppm for the mallard. The guideline (71-2) is fulfilled (MRID #45422419; 

MRID #45422420). 

Avian Subacute Dietary Studies 

Species 9% ai 5-Day LC50 Toxicity MRJD No. Study 

(PP~)' Category Author, Year Classification 

Northern 96 >5,230 Practically non- 45422419 Core 

bobwhite quail toxic Johnson, 1998 

(Colinus 

vir~inianus) a 

Mallard duck 96 >5,040 Practically non- 45422420 Core 

(Anas toxic Johnson, 1998 

platyrhynchos) 

Birds, Chronic 

Avian reproduction studies using the TGAI are required for clothianidin because birds may be 

subject to repeated or continuous exposure to the pesticide, especially preceding or during the 

breeding season. The preferred test species are mallard duck and bobwhite quail. The submitted 

Page 52 of 110 
data show that clothianidin exposure of 525 ppm adversely affected eggshell thickness for 

bobwhite quail, but did not result in chronic effects during reproduction for mallard duck; the 

guideline (7 1-4) is fulfilled (MRID #4542242 1 ; MRID #45422422). 

Avian Reproduction 

Species % ai NOAECILOAEC LOAEC MRID. No. Study 

(PP~) Endpoints Author, Year Classification 

Northern bobwhite 97.6 203525 Eggshell 45422421 Core 

quail thickness Gallagher et al., 

(Colinus virginianus) 2000 

Mallard duck 97.6 525/>525 No effect on 45422422 Supplemental 

(Anas platyrhynchos) reproduction Gallagher et 

al.., 2000 

Mammals, Acute and Chronic 

Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier 

laboratory mammalian studies, intended use pattern and pertinent environmental fate 

characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health 

Effects Division (HED) substitute for wild mammal testing. These toxicity values are reported 

below. 

Mammalian Acute and Chronic Toxicity I I I I I I I 

Species 

1 96 1 Acute I LD,, =5,000 mg/kg/day I Rat (Rattus 

Page 53 of 110 

% 

a.i. 

Mortality I 45422621 

Gardner, 1997 I 

Rabbit 

(S ylvilagus 

SP.) 

Test 

Type 

Decreased body weight gains and delayed sexual maturation (males only); decreased absolute thymus weight in F1 

pups (both sexes), and increased stillbirths (F1 and F2 litters). 

96 

Toxicity 

Developmental 

Affected 

Endpoints 

NOAELLOAEL = 25/75 

mglkglday 

(82512,475 ppm)4 

MRID No. 

Author, 

Year 

~evelo~ment~ 454227 12 and 

-13, 

1998 
Decreased sperm mobility and increased number of sperm with detatched heads (F1 and F2 litters). 

Premature deliveries, decreased gravid uterine weights, and increased litter incidence of missing lobe of the lung 

per fetus. 

pprn conversion based on: 

1 mg/kg/day = 20 pprn in adult rats, 10 pprn in younger rats, 7 pprn in mice and 33 pprn in rabbits. (Nelson, 

1975) 

pprn value determined from study. 

The results indicate that clothianidin is categorized as practically non-toxic to small mammals on 

an acute oral basis (LD,, = 389->5,000 mg/kg/day). 

In the 2-generation rat reproduction study, offspring systemic toxicity was detected for males and 

females at 500 pprn and reproductive toxicity was detected in males at 2500 ppm. The NOAEL 

for offspring systemic toxicity was 150 and 500 pprn for males and females, respectively, and the 

NOAEL for reproduction was 500 ppm. In the rabbit developmental study, toxicity was observed 

at 75 mg/kg/day; the NOAEL was 25 mg/kg/day. 

Insects, Acute Contact and Oral 

A honey bee acute contact study using the TGAI is required for clothianidin because its foliar 

application treatment use will result in honey bee exposure. The acute contact LD,,, using the 

honey bee, Apis mellifera, is an acute contact, single-dose laboratory study designed to estimate 

the quantity of toxicant required to cause 50% mortality in a test population of bees. The acute 

contact LD,, for clothianidin is 0.0439 pg a.i./bee and it is, therefore, classified as highly toxic to 

bees on a contact exposure basis [LD,, < 2 pg a.i./bee, based on toxicity categories in Atkins 

(1981)l. The guideline (141-1) is fulfilled (MRID No. 45422426). 

Five acute oral toxicity studies are available for clothianidin and its metabolites; however, they 

are categorized as supplemental because the submission of honey bee acute oral toxicity studies 

is not a guideline requirement. The Office of Pesticide Programs (OPP) does not have a 

categorization scheme for acute oral toxicity to honey bees. However, based on the ICBB (1985) 

acute oral toxicity categorization scheme, clothianidin would be considered highly toxic to the 

honey bee by the oral route. With the exception of TZNG, the clothianidin metabolites TMG, 

MNG, and TZMU would be virtually non-toxic to honey bees. TZNG would be moderately 

toxic. 

Nontarget Inscct Acute Contact and Oral Toxicity 

Honey bee Acute Contact Toxicity - Clothianidin 

I Honey bee Acute Oral Toxicity - Clothianidin Metabolite -TMG I 

SpeciesIStudy 

Duration 

Honey bee 

(Apis mellifera) 

48 hour 

Honey bee Acute Oral Toxicity - Clothianidin 

Page 54 of 110 

MKII) No. 

Author, Year 

Honey bee 

(Apis mellifera) 

48 hour 

Study 

% ai Classification 

96 

96 

LD50 

(pg ailbee) 

0.0439 

Toxicity 

Category 

highly toxic 

0.0037 45422426 

Weyman, 1998 

not applicable 

45422426 

Weyman, 1998 

Supplemental 

Core 
Insects, Mortality, Reproduction, and Feeding Capacity 

Two studies were submitted to show acute effects of corn (MRID 45422520) and summer rape 

(&ID 45422521) seeds treated with TI 435 FS600 (formulated product) on carabid beetles 

(Poecilus cupreus) under extended laboratory test conditions. The goal of these studies was to 

evaluate whether or not exposing carabid beetles to clothianidin treated corn or rape seeds 

incqeased mortality or decreased feeding rate compared to the controls. About one third of the 

adult carabid beetles exposed to the treated corn seeds at a seed treatment rate of 0.45 lb ai/A 

showed abnormalities (undescribed signs of intoxication). Rape seed treated with clothianidin at 

an application rate of 0.095 lb ai/A caused behavioral impacts (intoxication) to 63 % of adult 

cardbid beetles in the treatment group. The feeding rate of beetles in the treatment group was 

significantly reduced. There was also a significant difference in mortality (13.3 %) of the 

treatment group compared to the control. These studies were scientifically sound and classified 

as Supplemental. 

(Apis mellifera) 

48 hour 

Three studies (MRID Nos. 45422524,45422522, & 45422523) were submitted to show effects of 

clothianidin on the life cycle of rove beetles, (Aleochara bilineata) under extended laboratory 

conditions. The first study (MRID No. 45422524) was designed to evaluate the effects 

clothianidin would have on the beneficial ground beetles exposed to the pesticide in treated soil. 

Study endpoints were adult mortality and reproduction (total number of progeny produced). In 

this study, there were no significant differences observed between the control and clothianidin 

Wilkins, 2000 

treatment groups for adult mortality. Reproductive performance (as indicated by decreased 

number of progeny) was affected in the two highest clothianidin treatment groups (200 and 250 

pg a.i./kg soil). The goal ,of final two (2) rove beetle studies was to evaluate whether or not 

exposure of rove beetles to corn seeds (MRID No. 45422522) treated at a rate of 0.55 lb ai/A and 

to rape seeds (MRID No. 45422523) treated at a rate of 0.095 lb ai/A (10 g a.i./kg TI 435 FS 600) 

would result in significantly increased mortality of parent beetles and whether or not the offspring 

production rate would be adversely affected. The beetles exposed to the treated corn seed 

experienced a significant increase in mortality (55%) but no significant reproductive difference 

Page 55 of 110 

Honey bee Acute Oral Toxicity - Clothianidin Metabolite - TZMU 

Honey bee 

(Apis mellifera) 

48 hour 

98.8 

Honey bee Acute Oral Toxicity - Clothianidin Metabolite - TZNG 

Hohey bee 

(Abis mellifera) 

48 Ihour 

>I13 not applicable 45422429 

Wilkins, 2000 

98.6 

Supplemental 

3.95 not applicable 45422430 

Wilkins, 2000 

Supplemental 
when compared to the controls. The reproductive performance of the rove beetles was determined / by counting the number of rove beetles which emerged from the host pupae between days 39 and 

77 after treatment. Rove beetles exposed to the treated rape seed experienced an increase in 

mortality and a reduced parasitization capacity. The number of offspring that emerged 

(reproductive performance) in the rape seed treated test groups was not significantly lower than 

the control group. These studies were scientifically sound and classified as Supplemental. 

Insects, Residual Contact 

A honey bee toxicity of residues on foliage study is required on an end-use product for any 

pesticide intended for outdoor application when the proposed use pattern indicates that honey bees 

may be exposed to the pesticide and when the formulation contains one or more active ingredients 

having an acute contact honey bee LD,, which falls in the moderately toxic or highly toxic range. 

The purpose of this guideline study is to develop data on the residual toxicity to honey bees. Bee 

mortality determinations are made from bees exposed to treated foliage harvested at various time 

periods after treatment. Clothianidin, as indicated in the acute toxicity test (MRID 45422426), is 

highly toxic to honey bees on a contact basis. Pesticides toxic to honey bees require bee 

precautionary labeling on all end-use formulations and registrants are required to submit data in 

accordance with Guideline 141-2 - Honey Bee Toxicity of Residues on Foliage. A scientificallysound study was performed. 

Alfalfa foliage was sprayed with Clothianidin, as V-10066, at application rates of 30,60, and 90 g 

a.i./acre. Honey bees, three replicateslrate, were exposed in the lab to the weathered foliage at 

varying times until the mortality of bees exposed to residues was lower than 25%. Sublethal 

observations were also made. The RT2, for V-10066 at 30,60, and 90 g a.i.1acre were 11 1.68, 

179.51, and 512.39 hours, respectively. EFED expects clothianidin's residue on treated foliage to 

remain toxic to bees for days after clothianidin is applied. Results indicate that clothianidin, as V10066, should not be applied to blooming pollen-shedding or nectar-producing parts of plants. 

Non-target Insects - Toxicity of Residues on Foliage 

Species g a.i.lacre RT, (hours)' MRID No. Study Classification 

AuthorIYear 

Honey Bee 30 111.68 45490702 Supplemental 

(Apis mellifera) (0.07 lb ai/A) (4.7 days) Mayer, 2000 

Honey Bee 60 179.51 45490702 Supplemental 

(Apis mellifera) (0.13 lb ai/A) (7.5 days) Mayer, 2000 

Honey Bee 90 512.39 45490702 Supplemental 

(Apis mellifera) 0.21 (lb aiIA) (21.3 days) Mayer, 2000 

1 RT,, is the residual time required to reduce the activity of the test material and bring bee mortality down to 25% in cage test exposures to 

field-weathered spray deposits (Mayer and Johansen, 1990). The time period determinedby this toxicity value is considered to be time that 

the test material is expected to remain toxic to bees in the field from the residual exposure of the test material on vegetation at an expressed 

rate of application (Ib ai1A). 

Insects, Field Testing for Pollinators 

Six honey bee field studies were undertaken in various locations (Sweden, United Kingdom, 

France, Canada, United States, and Germany) to determine the residue levels of clothianidin in 

various parts of summer rape plants grown from seeds treated at various application rates (8.62 lb 

ail1000 lb seed or 0.038 lb ailacre; 10.4 lb ail1000 lb seed or 0.046 lb ailacre; 6 lb ail1000 lb seed 

Page 56 of 1 10 
or 0.04 lb ailacre; and 1 lb ail100 lb seed or 0.025 1b ailacre). Residue levels in the honey bees 

that foraged on the plants grown from the treated seeds were also determined. These studies were 

considered scientifically sound; however, they do not fulfill the requirements for a pollinator field 

test (OPPs Guideline 141-5) because the protocol was not approved by EPA. They are classified 

as Supplemental. An approved protocol would have required that the studies be conducted in the 

United States, longer duration of honey bee activity observations, and the use of replications in the 

treatments and controls for statistical analyses. Field exposure to the test substance and the bee 

observation period were too brief (< 30 days) to fully evaluate the impact the exposure levels of 

clothianidin would have had on the bee colonies tested. The complete life cycle for an individual 

worker bee during the time period tested would be approximately 63 days. 

These field studies evaluated the effects to small honey bee colonies hived on clothianidin rape 

seed treated and untreated (control) plots. Colonies were placed on the treated and untreated plots 

during the rape bloom stage approximately two months after the rape crops were planted. Bees 

were monitored for short periods of time to determine if they were being adversely affected by the 

clothianidin exposure as a result of the systemic activity demonstrated by clothianidin. Residues 

of clothianidin in the nectar from rape flowers ranged from 1.0 to 7.2 pg aikg. Nectar sampled 

from beehives ranged from 0.9 to 3.7pg aikg and nectar sampled from forage bees honey 

stomachs contained 8.6 pg aikg clothianidin. Residues of clothianidin were also found in forage 

bees (1.4 pg ailkg), rape flowers (3.3 - 4.1 pg ailkg), pollen taken from foraging bees (1.7 - 2.5 pg 

ailkg), and pollen from beehives (1.6 - 3.0 pg ailkg). These residues were a result of the 

clothianidin seed treatments performed approximately 60 days prior to sampling the commodities. 

Two (2) studies (MRID 45422436 & 45422437) also tested for the clothianidin metabolites, 

TZMU and TZNG, but residues of these metabolites were not found in the nectar and pollen 

samples analyzed. With the exception of one study (MRID 45422435), none of the studies 

reported mortality or adverse effects to the foraging activity of the bees. However, the residue 

levels in the nectar taken from the bees, 8.6 pg ailkg, exceeds the honey bee acute oral LD,, of 

3.7pg ailkg (MRID 45422426). One honey bee field study (MRID # 45422435) showed that 

mortality, pollen foraging activity, and honey yield were negatively affected by residues of 

clothianidin; however, residues were not quantified in this study. 

Non-target Insect Field Studies 

MRID# Study 

Location & 

Plant Date 

of Treated 

Seed 

Study 

Classification 

4542243 1 

- - 

BorlundaSkelinge, 

Sweden 

4/28/98 

Supplemental 

Chemical 

Application 

Rate 

Clothianidin 

8.6 g a.i./k+g seed 

or 

8.62 lb ail1000 lb 

seed 

or 

0.038 lb ailacre 

Sample 

Date(s) 

IS' week of 

July '98 

1'' week of 

July '98 - - 

7/3/98 

and 

7/2/98 

IS' week of 

July '98 

forage bees 1 1.4 I 

nectar from 1.2 and 

Page 57 of 1 10 

rape flowers 4.1 
Page 58 of 110 
Non-target Insect Field Studies 

* <Level of Quantification (LOQ) =1.0 pgkg and Level of Detection (LOD) = 0.3 pg/kg 

A seventh honey bee field study (MRID No. 45422440), reviewed under guideline 141-5, 

evaluated the effects of clothianidin treated pollen on the development of small honey bee 

colonies and on the behavior and mortality of honey bees. Three treatment levels and two 

controls were tested. One small beehive (about 500 bees) per treatment and control was tented on 

oat plots in cages and fed treated maize pollen. Pollen treated with clothianidin at a measured 

concentration level up to 19.7 pg ailkg produced no significant adverse effects to the parameters 

measured in this study based upon the visual inspection of the data. The parameters measured 

included mortality, foraging activity (including honey and pollen collection), comb production, 

honey storage behavior, population growth (including egg, larvae, pupae, and adult growth 

stages) and behavioral anomalies. Since there was only one replicate hive per treatment level, a 

statistical analysis could not be made of the data provided. MRID No. 45422440 was determined 

to be scientifically sound and classified as Supplemental. 

Spider, Mortality and Feeding Capacity 

Two extended laboratory studies (MRID Nos. 454225 18 & 454225 19) evaluated the effects of 

clothianidin treated seed on the wolf spider, Pardosa spp. (Araneae, Lycosidae). The goal of 

these studies was to evaluate whether or not exposing wolf spiders to treated corn and rape seeds 

increased mortality or decreased feeding rate compared to the controls. The seed treatment rate 

for the corn seeds was 48.8 g a.i./Unit (1 Unit = 50,000 seed) with 2 corn seeds per 1170 cm2 test 

box equivalent to 0.15 lb aiIA. The seed treatment rate for the rape seeds was 10 g a.i./kg TI 435 

FS 600 with 4 rape seeds per 178 cm2 test box equivalent to 0.06 lb ai/A. The studies' results 
indicated that the wolf spider mortality and feeding capacity in the clothianidin treatments were 

not significantly different from the controls. These studies were scientifically sound and classified 

as Supplemental. - 

Earthworm, Acute and Chronic 

Five acutelchronic earthworm studies were reviewed for clothianidin and its 

metaboliteltransformation products. These studies were conducted in compliance with the 

Organization for Economic Cooperation and Development (OECD) guidelines for testing of 

chemicals and were reviewed, by EFED, under EPA Ecological Effects Test Guidelines (U.S. 

EPA Ecological Effects Test Guidelines, April, 1996). EFED does not have a toxicity I 

categorization for earthworms. The clothianidin earthworm LC,, (conc. in soil) was determined 

to be 15.5 mglkg (MRID No. 454225 11) with the metabolite, MNG, and transformation product, 

TZNG, being less toxic to earthworms than the parent compound. EPA does not presently require 

reproductive or population toxicity testing with earthworms for pesticide registration; however, 

two studies indicate that clothianidin exhibits no apparent effect to earthworm reproduction at 

application rates equal to or greater than 0.054 lb ai1A (MRID 45422525) or population 

density/biomass at application rates equal to or greater than 0.08 lb ai/A (MRID 45422526). 

Clothianidin Metabolite - MNG 

Page 60 of 1 10 
I 

Earthworm Acute a1 

SpecieslStudy 

Duration 

Eisenia fetida 

14 days 

Clothianidin Transfo~ 

Eisenia fetida 

14 days 

d Chronic Toxicit 

LC501 NOAECI 

+ I (mglkg in dry (mg/kg in dry 

ai soil or lb I soil or lb ai/A) 

99.2 

- 

nation - 

99 

7 

ai/A) 

> 1,000 I 320 mgkg 

mgkg (nominal) 

(nominal) 

'roduct - TZNG 

I 

(nominal) (nominal) 

63 mgkg 

Endpoints 

reduction in 

body weights 

mortality 

reduction in 

body weight 

MRID# 

AuthorNear 

Study 

Classification 

454225 12 

Noack, 2000 

1 Equivalent to >500,000 clothianidin dressed corn seedsha 

Acceptable 

454225 13 

Noack, 2000 

MRID No. 45422525 - Earthworm (continued) 

2.7 x Ib ai * 500,000 seed 1.33 Ib ai 0.054 Ib ai - - corn seed HA HA Acre 

Acceptable 

MRID No. 45422526 - Earthworm 

91.4 g ai 0.2015 1b ai 0.08 lb ai -7 -- - ha 2.47 Acre Acre 

Toxicity to Aquatic Organisms 

Freshwater Fish, Acute 

Two freshwater fish toxicity studies using the TGAI are required to establish the acute toxicity of 

clothianidin to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill 

sunfish (a warmwater fish). The acute studies that were submitted that tested the parent 

compound showed that clothianidin is practically non-toxic to freshwater fish (LC,, >105.8 -1 17 

ppm). Studies on degradates (TMG, MNG, and TZNG) indicated a similar practically non-toxic 

profile (LC,, >I05 ppm). EFED will use the worst case value (LC,, >105.8 ppm) for evaluating 

acute toxic exposure to freshwater fish. The guideline (72-1) is fulfilled (MRID #45422407; 

MRID# 45422406). 

Bluegill sunfish 97.6 >I17 Practically non- 45422407 Core 

(Lepomis macrochirus) toxic Palmer et al., 

2000 

Page 61 of 110 
Freshwater Fish Acute Toxicity 

Species %ai 96-hour Toxicity MRlD No. Study 

LC50 (ppm) Category AuthorIYear Classification 

(nominal) 

Rainbow trout 96 >105.8 Practically non- 45422406 Supplemental 

(Oncorhynchus mykiss) toxic Wilhelmy et al., 

1998 

Rainbow trout 95.1 >I10 

(Oncorhynchus mykiss) TMG 

Rainbow trout 99.0 >lo5 

(Oncorhynchus mykiss) MNG 

Rainbow trout 99.0 >I16 

(Oncorhynchus mykiss) TZNG 

Practically non- 45422408 Supplemental 

toxic Dorgerloh, 2000 

Practically non- 45422409 Supplemental 

toxic Dorgerloh, 2000 

Practically non- 4542241 0 Supplemental 

toxic Dorgerloh, 2000 

Freshwater Fish, Chronic 

A freshwater fish early life-stage test using the TGAI is required for clothianidin because the enduse product may be transported to water from the intended use site, and the following conditions 

are met: (1) clothianidin is intended for use such that its presence in water is likely to be 

continuous or recurrent regardless of toxicity; (2) studies on aquatic invertebrates showed . 

reproductive effects (daphnid 21-day LOAEC = 0.12 ppm) and (3) clothianidin is persistent in 

water (e.g., half-life of 744 days aerobic soil metabolism). 

A chronic early life stage study conducted on the fathead minnow showed that exposure of 20 

pprn has the potential to affect length and dry weight of freshwater fish. The NOAEC of 9.7 pprn 

will be used for risk assessment purposes. The guideline (72-4) is fulfilled (MRID #45422413). 

Freshwater Fish Early Life-Stage Toxicity Under Flow-Through Condit~ons 

Species % ai NOAECILOAEC Endpoints MRID No. Study Classification 

(PP~) Affected AuthorIYear 

Fathead Minnow 97.6 9.7120 Length and dry 45422413 Supplemental 

(Pimephales promelas) weight Drottar et al., 2000 

Freshwater Invertebrates, Acute 

A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity 

of clothianidin to aquatic invertebrates. The preferred test species is Daphnia magna. The data 

that was submitted that tested the parent compound showed that clothianidin is practically nontoxic to Daphnia magna with an acute 48-hour EC,, value of >I19 ppm, but that it is very highly 

toxic to Chironomus riparius with an acute 48-hour EC,, value of 0.022 ppm. EFED will use the 

worst case value (EC,,= 0.022 ppm) for evaluating acute toxic exposure to freshwater 

invertebrates. Additional data (48-hour EC,,) on degradates (TZNG, MNG, and TMG) indicated 

a practically non-toxic to slightly toxic profile (EC,, = 64.0 to >115.2 pprn). The guideline 

requirements (72-2) for acute invertebrate toxicity are fulfilled (MRID #45422338; MRID 

#454224 14). 

Freshwater Invertebrate Acute Toxicity for Clothianidin 

Page 62 of 110 
Species % ai 48-hour EC,, Toxicity category MRID No. Study 

(PP~) Authornear Cliwslfication 

Waterflea 99 >I19 Practically non- 45422338 Core 

(Daphnia toxic Palmer, 2000 

mama) 

Midge 97.6 0.022* Very highly toxic 45422414 Supplemental 

(Chironomus Mattock, 2001 

ripanus) 

Waterflea 99.0 TZNG 64 Slightly toxic 45422401 Core 

(Daphnia Hendel, 2000 

mama) 

Waterflea 99.0 MNG >100.8 Practically non- 45422340 Core 

(Daphnia toxic Hendel, 2000 

magna) 

Waterflea 95.1 TMG >115.2 Practically non- 45422339 Supplemental 

(Daphnia toxic Hendel, 2000 

magna) 

* The EC,, value for exposure to Clothianidin TI-435 was the most sensitive; EC,, values for TZMU, MU, and TZNG were >I02 

ppm, A3.6 ppm, and 0.386 ppm, respectively. 

Freshwater Invertebrate, Chronic 

A freshwater aquatic invertebrate life-cycle test using the TGAI is required for clothianidin 

because the end-use product may be transported to water from the intended use site, and the 

following conditions are met: (1) the presence of clothianidin in water is likely to be continuous or 

recurrent and (2) aquatic acute LC,, or EC,, values are less than 1 ppm (i.e., 0.022 ppm), and (3) 

physicochemical properties indicate that clothianidin is persistent in the aquatic environment (e.g., 

half-life of 744 days aerobic soil metabolism). 

The preferred test is a 21-day life cycle on Daphnia magna. The data that were submitted show 

that clothianidin has the potential for chronic toxicity to daphnids and possibly other freshwater 

invertebrates. Exposure to 0.12 ppm can result in reproductive effects, including the reduced 

number of juveniles produced per adult. The NOAEC of 0.042 ppm will be used in assessing 

risk. The guideline (72-4) is fulfilled (MRID #45422412). 

Freshwater Aquatic Invertebrate Chronic Toxicity 

Spec~csl % ai 2 I -day MATC' Endpoints MRlD No. Study 

Static Renewal NOAEClLOAEC (PP~) Affected AuthorlYear Classification 

(PP~) 

Waterflea 96 0.042/0.12 ND Reproduction 45422412 Supplemental 

(Daphnia Noack et al., 

magna) Static 1998 

Renewal 

Freshwater Field Studies 

No data submitted. 

Estuarine and Marine Fish, Acute 

Page 63 of 1 10 
The preferred test species is sheepshead minnow. The data submitted showed that the LC,, = 93.6 

ppm; therefore, clothianidin is categorized as slightly toxic to estuarinelmarine fish on an acute 

basis. The guideline (72-3) is fulfilled (MRID #45422411). 

EsluarinelMarine Fish Acute Toxicity 

96-hour Toxicity MRlD No. Study 

SpeciesIStatic 8 ai LC50 (PP~) Category AuthorlYear Classification 

(nominal) 

Sheepshead minnow 97.6 >93.6 Slightly toxic 4542241 1 Supplemental 

Scheerbaum, 

1999 

Estuarine and Marine Fish, Chronic 

No data submitted. 

Estuarine and Marine Invertebrates, Acute I Acute toxicity testing with estuarinelmarine invertebrates using the TGAI-is required for 

clothianidin because the end-use product is expected to reach this environment due to its potential 

use on crops with significant acreage in coastal counties. The preferred test species are mysid 

shrimp and eastern oyster. The data showed that clothianidin significantly reduced survival of 

mysid shrimp at 0.05 1 ppm, categorizing the compound as very highly toxic. Clothianidin was 

categorized as practically non-toxic to Eastern oyster because adverse effects did not occur for this 

species up to concentrations of 129.1 ppm. EFED will use the worst case value, LC,, = 0.051 

ppm, for evaluating acute toxic exposure to estuarinelmarine invertebrates. The data requirements 

(72-3b) are fulfilled (MRID # 45422404; MRID #45422403). 

EstuarineIMarine Invertebrate Acute Toxicity 

SpecieslStatic or 9% ai. 96-hour Toxicity Category MRID No. Study 

Flow-through LC50 (ppm) AuthorIYcar Classification 

Eastern oyster 97.6 ECs0>129. 1 Practically non- 45422404 Core 

(Crassostrea virginica) toxic Scheerbaum, 1999 

Mysid 97.6 LCso=0.05 1 Very highly toxic 45422403 Core 

(Americamysis bahia) Drottar et al., 2000 

Estuarine and Marine Invertebrate, Chronic 

An estuarinelmarine invertebrate life-cycle toxicity test using the TGAI is required for 

clothianidin because the end-use product is expected to transport to an estuarinelrnarine 

environment from the intended use site, and the following conditions are met: (1) the pesticide is 

intended for use such that its presence in water is likely to be continuous or recurrent regardless of 

toxicity, (2) an aquatic acute LC,, or EC,, is less than 1 ppm (e.g., mysid LC,, = 0.051 ppm), and 

(3) studies of other organisms indicate that the reproductive physiology of fish and/or 

invertebrates may be affected, physicochemical properties indicate cumulative effects, or the 

pesticide is persistent in water (e.g., half-life of 744 days aerobic soil metabolism). 

The preferred test species is mysid shrimp. The data submitted indicate that clothianidin reduced 

the number of young per reproductive day at 9.7 ppb. The NOAEC of 5.1 ppb will be used in 

Page 64 of 110 
assessing risk. The guidelines (72-4c) have been fulfilled (MRID #45422405). 

Mysid 97.6 5.119.7 Reproduction 45422405 Core 

(Mysidopis bahia) Drottar et al., 2000 

Estuarine and Marine Field Studies 

No data submitted. 

Aquatic Plants 

Several aquatic plant toxicity studies using the TGAI are required to establish the toxicity of 

clothianidin to non-target aquatic plants. The recommendation is for testing on five species: 

freshwater green alga (Selenastrum ~'a~ricornutum), duckweed (Lemna gibba), marine diatom 

(Skeletonema costatum), blue-green algae (Anabaena flos-aquae), and a freshwater diatom. 

Studies submitted for two of the five recommended species showed that exposure to clothianidin 

at levels greater than or equal to 3.5 ppm reduced biomass of aquatic non-vascular plants and 

increased the incidence of necrotic fronds in aquatic vascular plants. Studies on degradates 

(TMG, MNG and TZNG) showed reductions in green algal cell density when exposed to levels 

>1.46 ppm. The EC,, of 64 ppm will be used for evaluating acute toxic exposure to non-target 

aquatic plants. The guideline requirements (122-2 and 123-2) are fulfilled (MRID #45422503; 

MRID #45422504) for two of the five required species. EFED needs 3 more Core clothianidin 

studies for the nonvascular surrogate species, marine diatom (Skeletonema costatum), blue-green 

algae (Anabaenaflosaquae), and a freshwater diatom. 

Page 65 of 1 10 

'able B-16: Non-target Aquatic Plant Toxicity 

Species 

[Study Type1 

Duckweed 

(Lemna gibba) 

[Tier 21 

Green Algae 

(Selenastrum 

capricomutum) 

[Tier 21 

Green Algae 

(~el'enastrum 

capricomutum) 

[Tier 21 

Green Algae 

(Selenastrum 

capricomutum) 

[Tier 11 

% a.i. 

97.6 

97.6 

95.1 

TMG 

99.0 

MNG 

Endpoints 

Affected 

Necrotic fronds 

Biomass 

Cell density 

None 

EC,dNOAEC 

(PP~) 

>I21159 

6413.5 

1011.46 

>100.61100.6 

MRID No. 

Author, Year 

45422503 

Palmer et al., 2000 

45422504 

Sutherland et al., 

2000 

45422505 

Dorgerloh, 2000 

45422506 

Dorgerloh, 2000 

Study 

Classification 

Core 

Core 

Core 

Core 
Page 66 of 1 10 

Terrestrial Plants 

Terrestrial Tier II studies are required for all low dose pesticides (those with the maximum use 

rate of 0.5 lbs a.i./A or less) and for any pesticide showing a negative response equal to or greater 

than 25% in Tier I studies. Two Tier I terrestrial plant toxicity studies were conducted to establish 

the toxicity of clothianidn to non-target terrestrial plants. The recommendations for seedling 

emergence and vegetative vigor studies are for testing of (1) six species of at least four 

dicotyledonous families, one species of which is soybean (Glycine max) and the second of which 

is a root crop, and (2) four species of at least two monocotyledonous families, one of which is 

corn (Zea mays). The studies that were submitted tested formulated products of clothianidin 

(49.3% TI-435 50% WDG). The results of these studies showed that exposure elicited no effect 

(that is, 2 25%) on non-target terrestrial plants, so Tier I1 tests were not necessary. The 

guidelines (122- 1 a and 122-lb) are fulfilled (MRID #4542250 1; MRID #45422502). 

45422507 

Dorgerloh, 2000 

Green Algae Cell density 

(Selenastrum 

capricomutum) 

[Tier 11 

99.0 Core 

TZNG 

>103/<103 
Appendix III. Bibliography 

Page 67 of 1 10 
The following studies have been submitted to the Agency and provide either core or some 

sumlemental information about clothianidin. 

MRID 45490703 Cassidy, P.S. 2001. TI-435 - Terrestrial field dissipation study, California 

1998. Unpublished study performed by Plant Sciences, Inc., Watsonville, CA and Ricerca, LLC, 

Concord, OH; sponsored and submitted by Tomen Agro, Inc., San Francisco, CA. Plant Sciences 

Project No. 98.322, Ricerca Project No. 7572-98-0092; Tomen Report No. TMN-0153 and 

Ricerca Report No.: 7572-98-0092-CR-001. Experiment initiation July 8, 1998 (p. 13) and 

completion March 16,2001 (field phase; p. 32). Final report issued July 19, 2001. 

MRID 45490704 Cassidy, P.S. 2001. TI-435 - Terrestrial field dissipation study, Washington 

1998. Unpublished study performed by Qualls Agricultural Laboratory, Ephrata, WA and 

Ricerca, LLC, Concord, OH; sponsored and submitted by Tomen Agro, Inc., San Francisco, CA. 

Qualls Project No. 98-54, and Ricerca Project No. 7570-98-0093; Tomen Report No. TMN-0155, 

and Ricerca Report No.: 7570-98-0093-CR-001. Experiment initiation July 7, 1998 and 

completion March 7,2001 (field phase; p. 30). Final report issued July 19,2001. 

MRID 45490705 Cassidy, P.S. 2001. TI-435 - Terrestrial field dissipation study, Georgia 1998. 

Unpublished study performed by Research Options, Inc., Montezuma, GA, Ricerca, LLC, 

Concord, OH, and A&L Great Lakes Laboratory, Inc., Fort Wayne, IN; sponsored and submitted 

by Tomen Agro, Inc., San Francisco, CA. Research Options Project No. 98-051, Ricerca Project 

No. 7574-98-0091-CR, A&L Great Lakes Laboratories, Inc. Project No.: F98845-001, Tomen 

Report No. TMN-0154 and Ricerca Report No. 7574-98-0091-CR-001. Experiment initiation 

July 22, 1998 and completion January 15,2001 (field phase; p. 31). Final report issued July 19, 

2001. 

MRID 45490701 Hewitt, A.J. Orchard airblast atomization droplet size spectra for V-10066lTI435 50 WDG. Unpublished study performed by Stewart Agricultural Research Services, Inc., 

Macon, MO; sponsored by Valent USA Corp., Walnut Creek CA (p. 26); and submitted by 

Tomen Agro, Inc., San Francisco, CA; Laboratory project no.: V00-22832. Final report issued 

August 29,2001. 

Mayer, D. and C. Johansen. Pollinator Protection: A Bee & Pesticide Handbook. Wicwas Press. 

Cheshire, CT (1990). 

Nelson, A.N. 1975. Appraisal of the Safety of Chemicals: Approximate Relation of Parts Per 

I Million in Diet to Mg/Kg/Day. Quarterly Report to the Editor on Topics of Current Interest. 

Association of Food and Drug Officials of the United States. 

Page 68 of 110 
Appendix IV. Structures of Clothianidin and Degradation Products 

Clothianidin (TI 435) 

WAC name: (E)- l-(2-Chloro- 1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine. 

CAS name: [C(E)]-N- [(2-Chloro-5-thiazolyl)methyl] -N'-methyl-N"-nitroguanidine. 

CAS No: 210880-92-5 (formerly 205510-53-8) 

SMILES string: CNC(=NN(=O)=O)NCc lcnc(s 1)Cl 

Unlabeled 

clothianidin-d, 

D = deuterium, 2H. 

Page 69 of 110 
TZNG (thiazolyl-nitroguanidine) 

IUPAC name: Not reported. 

CAS name: 

CAS No: 

N-(2-Chlorothiazol-5-ylmethyl)-N'-nitroguanidine. 

Not reported. 

Unlabeled 

* Position of the radiolabel. 

Page 70 of 1 10 
TZMU (thiazol yl-meth ylurea) 

IUPAC name: Not reported. 

CAS name: N-(2-Chlorothiazol-5-ylmethy1)-N'-methylurea. 

CAS No: Not reported. 

Unlabeled 

D = deuterium, 2H. 

Page 71 of 110 
MNG (methyl-nitroguanidine) 

IUPAC name: Not reported. 

CAS name: N-Methyl-N'-nitroguanidine. 

CAS No: Not reported. 

Unlabeled 

D = deuterium, 2H. 
TMG (thiazolyl-methylguanidirie) 

IUPAC name: Not reported. 

CAS name: N-(2-Chlorothiazol-5-ylmethy1)-N' -methylguanidine. 

CAS No: Not reported. 

Unlabeled 

D = deuterium, 2~. 

Page 73 of 110 
Appendix V. Results of FATE Model 

As part of the Tier I screening risk assessment, EPA uses models to estimate exposure of 

nontarget plants and animals to clothianidin. For terrestrial birds and mammals, estimates of 

initial levels of clothianidin residues on various food items consumed by wildlife using the 

Fletcher nomogram followed by a first order decline model such as FATE. The following table 

shows predicted residues immediately after a single turfgrass application (proposed label) on 

terrestrial food items following a single application of clothianidin calculated from Hoerger and 

Kenaga (1972) as modified by Fletcher et al. (1994). 

Table ma. Estimated Environmental Concentrations on Avian and Mammalian Food Item (ppm) Following a Single 

Application of Clothianidin at 0.2 Ib ai/A. 

Food Items EEC (PP~) 

Predicted Maximum Kesidue 

Short Grass 48 

Tall Grass 22 

Forage and small insects 27 

Fruits, pods, seeds and large insects 3 

EECs determined by FATE5 model 

Predicted residual concentrations (EECs) of clothianidin were compared to toxicity values for 

northern bobwhite quail and mouse to estimate acute and chronic risk quotients. The quail and 

mouse were chosen as representative terrestrial bird and mammal. 

Page 74 of 1 10 

----- -- - 
Qlenical Name: 

Use 

Fumdation 

LIpplication Rate 

Half-life 

Frequency d mication 

Nlaximun#ml~ear 

Shat Crass 

Tall Grass 

Boadeaf plawsn Insects 

FruiWpoMg insects 

Avian - 

Shatccass 

Tall Crass 

Boadeaf pladsn lnseds 

FruiWpoMg insects 

Pwte FQ 

v\l.ichdsesFKXexceed 

alron'c R3 Ah Acute 

Auanalraic , 

Mian 

Pane 

Mim 

Chronic 

fin first 56) 

Pwte FQ AcuteR3 Pale ~n --- - (dt. aA3s) (dt. aFps) 

ShcrtGrass (dl. aFps) 

a12 am 

Tall Grass 

a02 

a05 aa am 

Boadeaf plawsn insects a07 a05 am 

FruiWpoMginaeds Q01 am am 

am am am 

Figure Appendix V-2: Clothianidin's Use on Apples 

ELL-Fate Version 1.4 

Page 75 of 1 10 
Appendix VI: List of Listed EndangeredlThreatened Species 

Species Detail by State for Preliminary Assessment 

* Some species (gray wolf, etc ...) were omitted from the listings because they are not likely to be exposed due to to 

size, habitat, eating habits or other mitigating factors. 

SPIDER, MADLA'S CAVE Cicurina madla 

Arachnid 

SPIDER, KAUAI CAVE WOLF Adelocosa anops Arachnid 

SPIDER, ROBBER BARON CAVE Cicur~na baronia 

Arachnid 

SPIDER, SPRUCE-FIR MOSS Microhexura montivaga 

Arachnid 

HARVESTMAN, ROBBER BARON CAVE Texella cokendolpheri Arachnid 

SPIDER, TOOTH CAVE Neoleptoneta myopica Arachnid 

CICURINA VEND (NCN) Cicurina venii 

Arachnid 

SPIDER, VESPER CAVE Cicurina vespera 

Arachnid 

PSEUDOSCORPION, TOOTH CAVE Tartarocreag~s texana 

Arachnid 

SPIDER, GOVERNMENT CANYON CAVE Neoleptoneta microps Arachnid 

HARVESTMAN, BEE CREEK CAVE Texella reddelli 

Arachnid 

HARVESTMAN, BONE CAVE Texella reyesl 

Arachnid 

PEARLYMUSSEL, TURGID-BLOSSOM Epioblasma turgidula 

Clam 

PEARLYMUSSEL, PALE LILLIPUT Toxolasma cylindrellus 

Clam 

RIFFLESHELL, TAN Ep~oblasma florentina walkeri (=E. walkeri) 

Clam 

ROCK-POCKETBOOK, OUACHITA (=WHEELER'S Arkausia wheeleri 

Clam 

PM) 

PEARLYMUSSEL, PINK MUCKET Lampsilis abrupta Clam 

I PEARLYMUSSEL, WHlTE CATS PAW Epioblasma obliquata perobliqua Clam 

PEARLYMUSSEL, TUBERCLED-BLOSSOM Epioblasma torulosa torulosa Clam 

PEARLYMUSSEL, WHlTE WARTYBACK Plethobasus cicatricosus Clam 

PEARLYMUSSEL, YELLOW-BLOSSOM Epioblasma florentina florentina Clam 

PEARLYMUSSEL, PURPLE CATS PAW Epioblasma obliquata obliquata Clam 

PIGTOE, FINE-RAYED Fusconaia cuneolus Clam 

POCKETBOOK, FAT Potamilus capax Clam 

POCKETBOOK, SHINY-RAYED Lampsilis subangulata Clam 

PEARLYMUSSEL, DROMEDARY Dromus dromas Clam 

POCKETBOOK, SPECKLED Lamps~hs strecker~ Clam 

PEARLYMUSSEL, ORANGE-FOOTED Plethobasus cooperianus Clam 

PIGTOE, SOUTHERN Pleurobema georgianum Clam 

SLABSHELL, CHIPOLA Ellipho chipolaensis Clam 

RABBITSFOOT, ROUGH Quadrula cylindrica strigillata Clam 

PIGTOE, SHINY Fusconaia cor Clam 

Page 76 of 1 10 

-.d 
PIGTOE, ROUGH Pleurobema plenum 

PIGTOE, OVAL Pleurobema pyriforme 

CLUBSHELL, OVATE Pleurobema perovatum 

PIGTOE, FLAT (=MARSHALL'S MUSSEL) Pleurobema rnarshalli 

RIFFLESHELL, NORTHERN Epioblasma tomlosa rangiana 

PIGTOE, DARK Pleurobema furvum 

PIGTOE, CUMBERLAND (=CUMBERLAND Pleurobema gibberum 

PIGTOE MUSSEL 

CLUBSHELL 

POCKETBOOK, FlNE-LINED 

CLUBSHELL, BLACK (=CURTUS' MUSSEL) 

SPINYMUSSEL, JAMES RIVER 

SPINYMUSSEL, TAR RIVER 

CLUBSHELL, SOUTHERN 

COMBSHELL, CUMBERLAND 

COMBSHELL, SOUTHERN (=PENITENT MUSSEL) 

COMBSHELL, UPLAND 

PIGTOE, HEAVY (=JUDGE TAWS MUSSEL) 

MUSSEL, DWARF WEDGE 

ACORNSHELL, SOUTHERN 

HEELSPLITTER, INFLATED 

HEELSPLITI'ER, CAROLINA 

MOCCASINSHELL, COOSA 

THREERIDGE, FAT 

FANSHELL 

MUSSEL, WINGED MAPLELEAF 

MUSSEL, SCALESHELL 

BANKCLIMBER, PURPLE 

MUSSEL, OYSTER 

KIDN~Y SHELL, TRIANGULAR 

MUCKET, ORANGE-NACRE 

MOCCASINSHELL, OCHLOCKONEE 

MOCCASINSHELL, GULF 

PEARLYMUSSEL, LIl'TLE-WING 

PEARLYMUSSEL, HIGGINS' EYE 

MOCCASINSHELL, ALABAMA 

ELKTOE, APPALACHIAN 

ELKTOE, CUMBERLAND 

FATMUCKET, ARKANSAS 

MUSSEL, RING PINK (=GOLF STICK PEARLY) 

PEARLYMUSSEL, CUMBERLAND MONKEYFACE 

PEARLYMUSSEL, CRACKING 

PEARLYMUSSEL, BIRDWING 

BEAN, PURPLE 

PEARLYMUSSEL, CUMBERLAND BEAN 

STIRRUP SHELL 

PEARLSHELL, LOUISIANA 

PEARLYMUSSEL, APPALACHIAN 

PEARLYMUSSEL, CURTIS' 

PEARLYMUSSEL, GREEN-BLOSSOM 

PEARLYMUSSEL, ALABAMA LAMP 

AMPHIPOD, KAUAI CAVE 

SHRIMP, ALABAMA CAVE 

Pleurobema clava 

Lampsilis altilis 

Pleurobema curtum 

Pleurobema collina ' 

Elliptio steinstansana 

Pleurobema decisum 

Epioblasma brevidens 

Epioblasma penita 

Eploblasma metastriata 

Pleurobema taitianqm 

Alasmidonta heterodon 

Epioblasma othcaloogensis 

Potamilus inflatus 

Lasmigona decorata 

Medionidus parvulus 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Amblema neislerii Clam 

Cyprogenia stegaria Clam 

Quadrula fragosa Clam 

Leptodea leptodon Clam 

Elhptoldeus sloatianus Clam 

Epioblasma capsaeformis Clam 

Ptychobranchus greeni Clam 

Lampsilis perovalis Clam 

Medionidus simpsonianus Clam 

Mediouidus penicillatus Clam 

Pegias fabula Clam 

Lampsilis higginsii Clam 

Medionidus acutissimus Clam 

Alasmidonta raveneliana 

Alasmidonta atropurpurea 

Lampsilis powelli 

Obovaria retusa 

Quadrula intermedia 

Hemistena lata 

Conradilla caelata 

Villosa perpurpurea 

Villosa trabalis 

Quadrula stapes 

Margaritifera hembeli 

Quadrula sparsa 

Epioblasma florentina curtisii 

Epioblasma torulosa gubemaculum 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Clam 

Lamps~lis virescens Clam 

Spelaeorchestia koloana Crustacean 

Palaemonias alabamae Crustacean 

Page 77 of 1 10 
CRAYFISH, SHASTA Pacifastacus fortis 

SHRIMP, CALIFORNIA FRESHWATER Syncaris pacifica 

SHRIMP, CONSERVANCY FAIRY Branchinecta conservatio 

SHRIMP, KENTUCKY CAVE Palaemonias ganten 

CRAYFISH, NASHVILLE Orconectes shoupi 

CRAYFISH, CAVE (CAMBARUS ACULABRUM) Cambarus aculabrum 

AMPHIPOD, ILLINOIS CAVE Gammarus acherondytes 

SHRIMP, SAN DIEGO FAIRY Branchinecta sandiegonensis 

SHRIMP, SQUIRREL CHIMNEY CAVE Palaemonetes cummingi 

ISOPOD, LEE COUNTY CAVE Lirceus usdagalun 

ISOPOD, MADISON CAVE Antrolana lira 

ISOPOD, SOCORRO Thermosphaeroma thermophilus 

AMPHIPOD, PECK'S CAVE Stygobromus (=Stygonectes) pecki 

sH~IMP, RIVERSIDE FAIRY Streptocephalus woottonl 

SHRIMP, VERNAL POOL FAIRY Branchinecta lynch1 

SHRIMP, VERNAL POOL TADPOLE Lepidurus packardi 

SHRIMP, LONGHORN FAIRY Branchinecta longiantenna 

SKIPPER, PAWNEE MONTANE Hesperia leonardus montana 

GRASSHOPPER, ZAYANTE BAND-WINGED Trimerotropls infantilis 

BEETLE, OHLONE TIGER Cicindela ohlone 

MOTH, BLACKBURN'S SPHINX Manduca blackbumi 

MOTH, KERN PRIMROSE SPHINX Euproserpinus euterpe 

BEETLE, VALLEY ELDERBERRY LONGHORN Desmocerus califomicus chmorphus 

SKIPPER, LAGUNA MOUNTAIN Pyrgus ruralis lagunae 

BEEPE, TOOTH CAVE GROUND Rhadine persephone 

BEETLE, PURITAN TIGER Cicindela puritana 

BEETLE, NORTHEASTERN BEACH TIGER Cicindela dorsalis dorsahs 

BEETLE, KRETSCHMARR CAVE MOLD Texamaurops reddelli 

BEE~E, AMERICAN BURYING Nicrophorus americanus 

BEE~E, DELTA GREEN GROUND Elaphrus viridis 

BEETLE, COMAL SPRINGS RIFnE Heterelmis comalensis 

BEETLE, COMAL SPRINGS DRYOPID Stygopamns comalensis 

BEETLE, COFFIN CAVE MOLD Batrisodes texanus 

BEETLE, MOUNT HERMON JUNE Polyphylla barbata 

SKIPPER, CARSON WANDERING Pseudocopaeodes eunus obscurus 

FLY, DELHI SANDS FLOWER-LOVING Rhaphlomidas terminatus abdorninahs 

DRAGONFLY, HINES EMERALD Somatochlora hineana 

NAUCORID, ASH MEADOWS Ambrysus amargosus 

BU'ITERFLY, PALOS VERDES BLUE Glaucopsyche lygdamus palosverdesensis 

BEETLE, HELOTES MOLD Batrisodes venyivi 

RHADINE EXILIS (NCN) Rhadine exilis 

BUTTERlXY, FENDER'S BLUE Icaricia icarioides fenderi 

BUTTERFLY, LANGE'S METALMARK Apodemia mormo langei 

B~RFLY, K~RNER BLUE Lycaeides melissa samuehs 

BUTTERFLY, MlTCHELL'S SATYR Neonympha mitchellil mitchellii 

BUTTERFLY, MYRTLE'S SILVERSPOT Speyeria zerene myrtleae 

BUlTERFLY, UNCOMPAHGRE FRITILLARY Boloria acrocnema 

BUTTERFLY, SMITH'S BLUE Euphilotes enoptes smithi 

BUTTERFLY, LOTIS BLUE Lycaeides argyrognomon lotis 

BEETLE, HUNGERFORD'S CRAWLING WATER Brychius hungerfordi 

BUTTERFLY, MISSION BLUE Icaricia icanoides missionensis 

RHADINE INFERNALIS (NCN) Rhadine infernalis 

BUTTERFLY, BAY CHECKERSPOT Euphydryas editha bayensis 

BU'ITERFLY, BEHREN'S SILVERSPOT Speyeria zerene behrensii 

Page 78 of 1 10 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Crustacean 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect I 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 
BUTTERFLY, CALLIPPE SILVERSPOT 

BU?TERFLY, EL SEGUNDO BLUE 

BUTTERFLY, SCHAUS SWALLOWTAIL 

BUTTERFLY, SAN BRUNO ELFIN 

BUTTERFLY, SAINT FRANCIS' SATYR 

BUlTERFLY, OREGON SILVERSPOT 

BUTTERFLY, QUINO CHECKERSPOT 

BAT, GRAY 

WOODRAT, RIPARIAN 

SQUIRREL, VIRGINIA NORTHERN FLYING 

SQUIRREL, NORTHERN IDAHO GROUND 

SQUIRREL, MOUNT GRAHAM RED 

SQUIRREL, DELMARVA PENINSULA FOX 

SQUIRREL, CAROLINA NORTHERN PLYING 

SHREW, BUENA VISTA 

MOUSE, ALABAMA BEACH 

MOUSE, ANASTASIA ISLAND BEACH 

MOUSE, CHOCTAWHATCHEE BEACH 

MOUSE, PACIFIC POCKET 

MOUSE, PERDIDO KEY BEACH 

MOUSE, PREBLE'S MEADOW JUMPING 

MOUSE, SALT MARSH HARVEST 

MOUSE, SOUTHEASTERN BEACH 

BAT, INDIANA 

VOLE, AMARGOSA 

VOLE, FLORIDA SALT MARSH 

VOLE, HUALAPAI MEXICAN 

BAT, HAWAIIAN HOARY 

KANGAROO RAT, FRESNO 

BAT, LESSER (=SANBORN'S) LONG-NOSED 

BAT, MEXICAN LONG-NOSED 

BAT, OZARK BIG-EARED 

KANGAROO RAT, SAN BERNARDINO 

KANGAROO RAT, STEPHENS' 

KANGAROO RAT, TIPTON 

RABBm, PYGMY 

KANGAROO RAT, MORRO BAY 

BAT, VIRGINIA BIG-EARED 

KANGAROO RAT, GIANT 

SNAIL, FLAT-SPIRED THREE-TOOTHED 

SNAIL, NEWCOMB'S 

PEBBLESNAIL, FLAT 

CAVESNAIL, TUMBLING CREEK 

CAMPELOMA, SLENDER 

RIVERSNAIL, ANTHONY'S 

ELIMIA, LACY 

ROCKSNAIL, PAINTED 

ROCKSNAIL, PLICATE 

ROCKSNAIL, ROUND 

MARSTONIA, ROYAL (=ROYAL SNAIL) 

SHAGREEN, MAGAZINE MOUNTAIN 

SNAIL, ARMORED 

SNAIL, BLISS RAPIDS 

Speyeria callippe callippe 

Euphilotes battoides allynl 

Heraclides aristodemus ponceanus 

Callophrys mossil bayensis 

Neonympha mitchellii franclsci 

Speyeria zerene hippolyta 

Euphydryas editha quino (=E. e. wrighti) 

Myotis grisescens 

Neotoma fuscipes riparia 

Glaucomys sabrinus fuscus 

Spermophllus brunneus brunneus 

Tamiasciurus hudsonlcus grahamensis 

Sciurus niger cinereus 

Glaucomys sabrinus coloratus 

Sorex ornatus relictus 

Peromyscus pohonotus ammobates 

Peromyscus polionotus phasma 

Peromyscus pohonotus allophrys 

Perognathus longimembris pacificus 

Peromyscus polionotus trissyllepsis 

Zapus hudsonius preblei 

Reithrodontomys raviventris 

Peromyscus polionotus niveiventris 

Myotis sodalis 

Microtus californicus scirpensis 

Microtus pennsylvanicus dukecampbelli 

Microtus mexicanus hualpaiensls 

Lasiurus cinereus semotus 

Dipodomys nitratoides exilis 

Leptonycteris curasoae yerbabuenae 

Leptonycteris nivalis 

Corynorhinus (=Plecotus) townsendii ingens 

Dipodomys memami parvus 

Dipodomys stephensi (incl D. cascus) 

Dipodomys nitratoides nitratoides 

Brachylagus idahoensis 

Dlpodomys heermanni morroensis 

Corynorhinus (=Plecotus) townsendii virginianus 

Dipodomys ingens 

Triodopsis platysayoides 

Erinna newcombi 

Lepyrium showalteri 

Antrobia culveri 

Campeloma decampi 

Athearnia anthonyi 

Ehmia crenatella 

Leptoxis taeniata 

Leptoxls phcata 

Leptoxis ampla 

Pyrgulopsis ogmorhaphe 

Mesodon magazinensis 

Pyrgulopsis (=Marstonia) pachyta 

Taylorconcha serpenticola 

5 

Page 79 of 1 10 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Insect 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Mammal 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 
SNAIL, MORRO SHOULDERBAND 

SNAIL, IOWA PLEISTOCENE 

AMBERSNAIL, KANAB 

SNAIL, NOONDAY 

SNAIL, OAHU TREE (MANY SPECIES) 

SNAIL, PAINTED SNAKE COILED FOREST 

SNAIL, SNAKE RIVER PHYSA 

SNAIL, TULOTOMA 

SNAIL, UTAH VALVATA 

SNAIL, VIRGINIA FRINGED MOUNTAIN 

SPRINGSNAIL, ALAMOSA 

SPRINGSNAIL, BRUNEAU HOT 

SPRINGSNAIL, IDAHO 

SPRINGSNAIL, SOCORRO 

LIOPLAX, CYLINDRICAL 

LIMPET, BANBURY SPRINGS 

SNAIL, CHlTENANGO OVATE AMBER 

Helminthoglypta wakeriana 

Discus macclintocki 

Oxyloma haydeni kanabensis 

Mesodon clarki nantahala 

Achatinella spp. 

Anguispira picta 

Physa narricina 

Tulotoma magnifica 

Valvata utahensis 

Polygyriscus virginianus 

Tryonia alamosae 

Pyrgulopsis bruneauensis 

Fontelicella idahoensis 

Pyrgulopsis neomexicana 

Lioplax cyclostomaformis 

Lanx sp. 

Succinea chittenangoensis 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 

Snail 
Appendix VII: PRZMIEXAMS output 

A-VII. Part 1: Modeling of Clothianidin Cotton Seed Treatment 

Key files: 

PRZM In~ut: 

\Sorgh-Cott~Seed0506O9WE4~CottSd~O5O6O9ddprzm3.inp 

EXAMS Environment Input: 

\~or~h-~ott~~eed050609~~4~~ott~d~050609d~~z2e~.exa 

EEC Summarv File: 

\Sorgh-Cott~Seed050609WE4~CottSdC050609d.out 

Page 81 of 110 
PRZM Input File: 

MS Cotton; 8/13/2001 

"Yazoo County; MLRA 134; Metfile: W03940.dvvf (old: Metl31.met); 

*** Record 3: 

EECs (0.1 exceedance probability), Clothianidin on Cotton Seed: 

0.74 0.15 0 17 1 1 

*** Record 6 -- ERFLAG 

4 

*** Record 7: 

Probabllrty 

0.1 

0 -49 0.4 0.75 10 

*** Record 8 

3 

*** Record 9 

Peak 

0.1 5291 

1 0.2 125 9 8 3 99 93 92 

2 0.2 125 0 

12 0 

9 8 3 94 84 83 

3 0.2 125 0 

12 0 

9 8 3 99 83 83 0 12 0 *** Record 9a-d 

1 2 5 

0101 1601 0102 1602 0103 1603 0104 1604 2504 0105 1605 0106 1606 0107 1607 

0108 

.500 .517 .532 .549 .567 .591 .617 .667 .705 .718 .699 .620 .496 .354 .303 

.3 05 

.014 .014 .014 -014 .014 -014 .014 -014 .014 -014 .014 .014 .014 .014 .014 

.014 

Page 82 of 110 

96 hr 

0.1 5208 

a UaY 

0.1 4928 

60 Day 

0.14297 

90 Uay 

0.1 382 

Yearly 

0.09993: 
1608 0109 1609 0110 1610 0111 1611 0112 1612 

.289 -343 .359 .223 .327 .376 .425 .465 .494 

.014 .014 .014 .014 .014 .014 .014 .014 .014 

*** Record 10 -- NCPDS, the number of cropping periods 

3 0 

*** Record 11 

010561 070961 220961 1 

010562 070962 220962 2 

010563 070963 220963 3 

010564 070964 220964 1 

010565 070965 220965 2 

010566 070966 220966 3 

010567 070967 220967 1 

010568 070968 220968 2 

010569 070969 220969 3 

010570 070970 220970 1 

010571 070971 220971 2 

010572 070972 220972 3 

010573 070973 220973 1 

010574 070974 220974 2 

010575 070975 220975 3 

010576 070976 220976 1 

010577 070977 220977 2 

010578 070978 220978 3 

010579 070979 220979 1 

010580 070980 220980 2 

010581 070981 220981 3 

010582 070982 220982 1 

010583 070983 220983 2 

010584 070984 220984 3 

010585 070985 220985 1 

010586 070986 220986 2 

010587 070987 220987 3 

010588, 070988 220988 1 

010589 070989 220989 2 

010590 070990 220990 3 

*** Record 12 -- PTITLE 

Clothianidin - 1 applications @ 0.0224 kg/ha *** Record 13 

3 0 1 0 0 

*** Record 15 -- PSTNAM 

Clothianidin 

Page 83 of 110 
*** Record 16 

260461 0 8 1.90.0224 1 0 

260462 0 8 1.90.0224 1 0 

260463 0 8 1.90.0224 1 0 

260464 0 8 1.90.0224 1 0 

260465 0 8 1.90.0224 1 0 

260466 0 8 1.90.0224 1 0 

260467 0 8 1.90.0224 1 0 

260468 0 8 1.90.0224 1 0 

260469 0 8 1.90.0224 1 0 

260470 0 8 1.90.0224 1 0 

260471 0 8 1.90.0224 1 0 

260472 0 8 1.90.0224 1 0 

260473 0 8 1.90.0224 1 0 

2'60474 0 8 1.90.0224 1 0 

260475 0 8 1.90.0224 1 0 

260476 0 8 1.90.0224 1 0 

260477 0 8 1.90.0224 1 0 

260478 0 8 1.90.0224 1 0 

260479 0 8 1.90.0224 1 0 

260480 0 8 1.90.0224 1 0 

260481 0 8 1.90.0224 1 0 

260482 0 8 1.90.0224 1 0 

26P483 0 8 1.90.0224 1 0 

26b484 0 8 1.90.0224 1 0 

26i0485 0 8 1.90.0224 1 0 

2610486 0 8 1.90.0224 1 0 

2610487 0 8 1.90.0224 1 0 

26i0488 0 8 1.90.0224 1 0 

26i0489 0 8 1.90.0224 1 0 

26i0490 0 8 1.90.0224 1 0 

*** Record 17 

0 1 0 

*** Record 19 -- STITLE 

Loring Silt Loam; HYDG: C 

*** Record 20 

155 001000000 

*** Record 26 

0 0 0 

*** Record 30 

4 188 

*** Record 33 

6 

1 13 1.4 0.385 0 0 0 

0.0009320.000932 0 

0.1 0.385 0.151 2.18 0 

2 2 3 1.4 0.37 0 0 0 

0.0009320.000932 0 

1 0.37 0.146 0.49 0 

3 3 3 1.4 0.37 0 0 0 

0.0009320.000932 0 

3 0.37 0.146 0.16 0 

4 3 0 1.45 0.34 0 0 0 

0.0009320.000932 0 

5 0.34 0.125 0.124 0 

5 2 3 1.49 0.335 0 0 0 

0.0009320.000932 0 

1 0.335 0.137 0.07 0 

6 3 3 1.51 0.343 0 0 0 

0.0009320.000932 0 

3 0.343 0 .I47 0.06 0 

***Record 40 

Page 84 of 110 
0 

YEAR 10 YEAR 10 YEAR 10 1 

1 

1 ----- 

7 YEAR 

PRCP TCUM 0 0 

RUNF TCUM 0 0 

INFL TCUM 1 1 

ESLS TCUM 0 0 1.OE3 

RFLX TCUM 0 0 1.OE5 

EFLX TCUM 0 0 1.OE5 

RZFX TCUM 0 0 1.OE5 

A-VII, Part 2: Modeling of Clothianidin Sorghum Seed Treatment 

Key files: 

PRZM Input: 

\Sorgh-Cott~SeedO50609\PE4E4SorghSd~O5O6O9~Cprzm3 .inp 

EXAMS Environment Input: 

\Sorgh-Cott~Seed050609\PE44SorghSd~O50609c~pz2ex.exa 

EEC Summarv File: 

\Sorgh-Cott~Seed050609\PE4~SorghSd~050609c.out 

Page 85 of 110 
PRZM Sorghum Seed Input File: 

KSSorghum; 10/09/02 

EECs (0.1 exceedance probability), Clothianidin on Sorghum Seed: 

"Osage County in MLRA 112; County nearest weather station Topeka (W13996) and 

still in MLRA 112 (East Central KS); Metfile: W13996.dvf, (old metfile: 

Met112 .met) " 

Probabllrty 

0.1 

*** Record 3: 

0.73 0.3 0 17 1 3 

*** Record 6 -- ERFLAG 

peak 

0.044403 

** * Recbrd 7 : 

0.43 0.264 1 10 

*** Record 8 

1 

*** Record 9 

1 0.1 12 0 100 3 89 86 87 0 12 0 *** Record 9a-d 

1 2 6 

Page 86 of 110 

96 hr 

0.0441 14 

2' 'Jay 

0.0431 22 

60 'Jay 

0.041 163 

90 Day 

0.039691 

yearly 

0.03005E 
0101 1601 0102 1602 0103 1603 0104 1604 0105 0505 1605 2005 0106 1606 0107 1607 

.I61 .I63 .I65 .I68 .I74 .I85 .I99 .217 .231 .372 .425 .449 .448 .385 .224 .I17 

.023 .023 .023 -023 .023 .023 -023 .023 .023 .023 .023 .023 .023 .023 .023 .023 

0108 1608 0109 1609 0110 1610 0111 1611 0112 1612 

.076 .076 .078 .I86 .I94 .I71 .I62 .I71 .I75 .I78 

.023 .023 .023 .023 .023 .023 .023 .023 .023 .023 

*** Record 10 -- NCPDS, the number of cropping periods 

3 0 

*** Record 11 

200561 200961 011061 1 

200562 200962 011062 1 

200563 200963 011063 1 

200564 200964 011064 1 

200565 200965 011065 1 

200566 200966 011066 1 

200567 200967 011067 1 

200568 200968 011068 1 

200569 200969 011069 1 

200570 200970 011070 . 1 

200571 200971 011071 1 

200572 200972 011072 1 

200573 200973 011073 1 

200574 200974 011074 1 

200575 200975 011075 1 

200576 200976 011076 1 

200577 200977 011077 1 

200578 200978 011078 1 

200579 200979 011079 1 

200580 200980 011080 1 

2100581 200981 011081 1 

200582 200982 011082 1 

200583 200983 011083 1 

2100584 200984 011084 1 

200585 200985 011085 1 

200586 200986 011086 1 

200587 200987 011087 1 

200588 200988 011088 1 

200589 200989 011089 1 

200590 200990 011090 1 

*** Record 12 -- PTITLE 

Clothianidin - 1 applications @ 0.0224 kg/ha 

*** Record 13 

3 0 1 0 0 

*** Record 15 -- PSTNAM 

Clothianidin 

*** Record 16 

150561 0 8 1.90.0224 1 0 

150562 0 8 1.90.0224 1 0 

150563 0 8 1.90.0224 1 0 

150564 0 8 1.90.0224 1 0 

150565 0 8 1.90.0224 1 0 

150566 0 8 1.90.0224 1 0 

150567 0 8 1.90.0224 1 0 

150568 0 8 1.90.0224 1 0 

150569 0 8 1.90.0224 1 0 

150570 0 8 1.90.0224 1 0 

150571 0 8 1.90.0224 1 0 

150572 0 8 1.90.0224 1 0 

150573 0 8 1.90.0224 1 0 

150574 0 8 1.90.0224 1 0 

150575 0 8 1.90.0224 1 0 

150576 0 8 1.90.0224 1 0 

Page 87 of 110 
150577 0 8 1.90.0224 1 0 

150578 0 8 1.90.0224 1 0 

150579 0 8 1.90.0224 1 0 

150580 0 8 1.90.0224 1 0 

150581 0 8 1.90.0224 1 0 

150582 0 8 1.90.0224 1 0 

150583 0 8 1.90.0224 1 0 

150584 0 8 1.90.0224 1 0 

150585 0 8 1.90.0224 1 0 

150586 0 8 1.90.0224 1 0 

150587 0 8 1.90.0224 1 0 

150588 0 8 1.90.0224 1 0 

150589 0 8 1.90.0224 1 0 

150590 0 8 1.90.0224 1 0 

*** Record 17 

0 1 0 

*** Record 19 -- STITLE 

"Dennis Silt Loam; Benchmark Soil, Hydrologic Group C" 

*** Record 20 

12 0 001000000 

*** Record 26 

0 0 0 

*** Record 30 

4 18 8 

*** Record 33 

4 

1 ' 10 1.55 0.247 0 0 0 

0.0009320.000932 0 

0.1 0.247 0.097 1.74 0 

2 2 4 1.55 0.247 0 0 0 

0.0009320.000932 0 

2 0.247 0.097 1.74 0 

3 10 1.6 0.316 0 0 0 

0.0009320.000932 0 

5 0.316 0.166 0.174 0 

4 7 6 1.6 0.348 0 0 0 

0.0009320.000932 0 

2 0.348 0.198 0.116 0 

***Record 40 

0 

YEAR 10 YEAR 10 YEAR 10 1 

1 

1 ----- 

7 YEAR 

PRCP TCUM 0 0 

RUNF TCUM 0 0 

INFL TCUM 1 1 

ESLS TCUM 0 0 1.OE3 

RFLX TCUM 0 0 1.OE5 

EFLX TCUM 0 0 1.OE5 

RZFX TCUM 0 0 1.OE5 

A-VII, Part 3: Modeling of Clothianidin Multiple (3) Foliar Applications on Potatoes 

Key files: 

PRZM Input: , 

\Potato-ME050603\Potato~3appsLateSeasn~CAM2~Clothainprzm3 .inp 

r EXAMS Environment Input: 

Page 88 of 110 

--- - - 
\Potato-MEO50603\Potato~3appsLateSeasn~CAM2~Clothain~pz2ex.exa 

EEC Summarv File: 

\Potato-ME050603WE4~Potat050603b.out 

Also presented, but not used in EEC calculations (same scenario, early season applications): 

PRZM Input: 

\Potato-ME050603Wotato~3appsEarlySeasn~CAM2~Clothain~przm3 .inp 

EXAMS Environment Input: 

Wotato-ME050603\Potato~3appsEarlySeasn~CAM2~C1othain~pz2ex.exa 

EEC Summarv File: 

\Potato-ME050603WE4~Potat050603a.out 

Estimated Environmental ( Dissolved Water) Concentrations, 3 Late-Season Applications of 

C1 

Page 89 of 1 10 
EECs (0.1 exceedance probability), Clothianidin on Potatoes (3 late-season 

1 I I I I I I 

pplications): 

Probability 

0.1 

PRZM - Maine Potatoes, 3 Late-Season applications Input File: 

Mepotato; 8/05/02 

"Maine Potato, MLRA 146, Modified from MEPOTIRl.inp from F Drive; Metfile: 

W14607.dvf (old: Metl46.met), 

*** Record 3: 

0.8 0.36 0 12.5 1 3 

*** Record 6 -- ERFLAG 

4 

*** Record 7: 

0.28 1.34 1 10 3 6 354 

*** Record 8 

1 

*** Record 9 

1 0.1 6 0 4 0 3 89 86 87 0 3 0 

*** Record 9a-d 

1 2 8 

Peak 

1.8969 

Page 90 of 1 10 

-.--- --- "- 

96 hr 

1.5305 

21 Day 

1.0448 

60 Day 

0.86999 

90 Day 

0.81 952 

Yearly 

0.27206 
0101 1601 0102 1602 0103 1603 0104 1604 0105 0505 1505 1605 2005 0106 1606 0107 

.593 .592 .591 .590 .589 .594 .604 .623 .640 .631 .758 .762 .801 .788 .645 .400 

.014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 ,014 .014 .014 .014 .014 

1607 0108 1608 0109 1609 0110 0510 1610 0111 1611 0112 1612 

.310 .I73 .056 .053 .I35 .267 .511 .544 .570 .586 .591 .593 

.014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 

*** Record 10 -- NCPDS, the number of cropping periods 

3 0 

*** Record 11 

300561 011061 051061 1 

300562 011062 051062 1 

300563 011063 051063 1 

300564 011064 051064 1 

300565 011065 051065 1 

300566 011066 051066 1 

300567 011067 051067 1 

300568 011068 051068 1 

300569 011069 051069 1 

300570 011070 051070 1 

300571 011071 051071 1 

300572 011072 051072 1 

300573 011073 051073 1 

300574 011074 051074 1 

300575 011075 051075 1 

300576 011076 051076 1 

3'00577 011077 051077 1 

300578 011078 051078 1 

300579 011079 051079 1 

3100580 011080 051080 1 

300581 011081 051081 1 

300582 011082 051082 1 

300583 011083 051083 1 

3100584 011084 051084 1 

3l00585 011085 051085 1 

3'00586 011086 051086 1 

3100587 011087 051087 1 

3'00588 011088 051088 1 

300589 011089 051089 1 

3100590 011090 051090 1 

*** Record 12 -- PTITLE 

Clothianidin - 3 applications @ 0.0747 kg/ha 

*** Record 13 

9 0 1 0 0 

*** Record 15 -- PSTNAM 

Clothianidin 

*** Record 16 

020961 0 2 0.00.0747 0.99 0.01 

090961 0 2 0.00.0747 0.99 0.01 

160961 0 2 0.00.0747 0.99 0.01 

020962 0 2 0.00.0747 0.99 0.01 

090962 0 2 0.00.0747 0.99 0.01 

160962 0 2 0.00.0747 0.99 0.01 

020963 0 2 0.00.0747 0.99 0.01 

090963 0 2 0.00.0747 0.99 0.01 

160963 0 2 0.00.0747 0.99 0.01 

020964 0 2 0.00.0747 0.99 0.01 

090964 0 2 0.00.0747 0.99 0.01 

160964 0 2 0.00.0747 0.99 0.01 

020965 0 2 0.00.0747 0.99 0.01 

090965 0 2 0.00.0747 0.99 0.01 

160965 0 2 0.00.0747 0.99 0.01 

020966 0 2 0.00.0747 0.99 0.01 

Page 91 of 1 10 

m- 
Page 92 of 1 10 
020987 0 2 0.00.0747 0.99 0.01 

090987 0 2 0.00.0747 0.99 0.01 

160987 0 2 0.00.0747 0.99 0.01 

020988 0 2 0.00.0747 0.99 0.01 

090988 0 2 0.00.0747 0.99 0.01 

160988 0 2 0.00.0747 0.99 0.01 

020989 0 2 0.00.0747 0.99 0.01 

090989 0 2 0.00.0747 0.99 0.01 

160989 0 2 0.00.0747 0.99 0.01 

020990 0 2 0.00.0747 0.99 0.01 

090990 0 2 0.00.0747 0.99 0.01 

160990 0 2 0.00.0747 0.99 0.01 

*** Record 17 

0 1 0 

*** Record 18 

0 0 0.5 

*** Record 19 -- STITLE 

"Conant Silt Loam MLRA M-146, Aroostook County, ME" 

*** Record 20 

100 001000000 

*** Record 26 

0 0 0 

*** Record 30 

4 18 8 

*** Record 33 

4 

1 10 1.25 0.341 0 0 

0.0009320.000932 0 

0.1 0.341 0.121 4.64 0 

2 16 1.25 0.341 0 0 

0.0009320.000932 0 

1 0.341 0.121 4.64 0 

3 6 4 1.4 0.266 0 0 

0.0009320.000932 0 

1 0.266 0.116 0.174 0 

4 10 1.6 0.261 0 0 

0.0009320.000932 0 

1 0.261 0.111 0.116 0 

***Record 40 

0 

1 

1 

7 

PRCP 

RUNF 

INFL 

ESLS 

RFLX 

EFLX 

RZFX 

YEAR 

----- 

YEAR 

TCUM 

TCUM 

TCUM 

TCUM 

TCUM 

TCUM 

TCUM 

10 YEAR 10 YEAR 10 1 

Estimated Environmental ( Dissolved Water) Concentrations, 3 Early-Season Applications of 

Clothianidin on Potatoes (total season rate of 0.2 lb ai per acre). (not used in ecological risk 

assessment). 

Page 93 of 110 
Page 94 of 1 10 
A-VII, Part 4: Modeling of Clothianidin Single Broadcast Application on Potatoes 

EECs (0.1 exceedance probability), Clothianidin on Potatoes (3 early-season applications): 

Key files: 

PRZM Input: 

\Potato-ME050603\Potato-ME050603~przm3.inp 

Yearly 

0.057842 

EXAMS Environment Input: 

file accidently erased. 

90Day 

0.16045 

EEC Summarv File: 

\Potato-MEO50603YPRZM-EX-Clothia-ME-pota-050603 .out 

60Day 

0.22252 

Estimated Environmental ( Dissolved Water) Concentrations, Single Broadcast Application of 

21 Day 

0.46441 

Clothianidin on Potatoes (0.2 lb ai per acre). 

Year Peak 60 Day 90 Day Yearly I I I n ni nni 

96 hr 

0.90965 

Probability 

0.1 

Page 95 of 110 

Peak 

1.1506 
EECs (0.1 exceedance probability), Clothianidin on Potatoes (single soil apI ication): 

PRZM - Maine Potatoes, Single Soil application Input File: 

C:\Doc2003\Actions\Clothianidin\Model-CIothia\PRZM-input-stdfile-used0506~MEpotato 

C-mrb.rtf 

Mepotato; 8/05/02 

"Maine Potato, MLRA 146, Modified from MEPOTIRl.inp from F Drive; Metfile: 

W14607.dvf (old: Metl46.met), 

*** Record 3: 

0.8 0.36 0 12.5 1 3 

*** Record 6 -- ERFLAG 

4 

*** Record 7: 

0.28 1.34 1 10 3 6 354 

Page 96 of 110 

Probability 

0.1 

Peak 

1.40788 

96 hr 

1 .I 0988 

21 Day 

0.54766 

60 Day 

0.2321 2 

90 Day 

0.16479 

Yearly 

0.050529 
*** Record 8 

1 

*** Record 9 

1 0.1 6 0 4 0 3 89 86 87 0 3 0 

*** Record 9a-d 

1 2 8 

0101 1601 0102 1602 0103 1603 0104 1604 0105 0505 1505 1605 2005 0106 1606 0107 

.593 .592 .591 .590 .589 -594 .604 .623 .640 .631 .758 .762 .801 .788 .645 .400 

.014 .014 .014 .014 .014 -014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 

1607 0108 1608 0109 1609 0110 0510 1610 0111 1611 0112 1612 

.3LO .I73 .056 .053 .I35 .267 .511 .544 .570 .586 .591 .593 

.014 .014 .014 .014 .014 .014 .014' .014 .014 .014 -014 .014 

*** Record 10 -- NCPDS, the number of cropping periods 

3 0 

*** Record 11 

300561 011061 051061 1 

300562 011062 051062 1 

300563 011063 051063 1 

300564 011064 051064 1 

300565 011065 051065 1 

300566 011066 051066 1 

300567 011067 051067 1 

300568 011068 051068 1 

300569 011069 051069 1 

300570 011070 051070 1 

300571 011071 051071 1 

300572 011072 051072 1 

300573 011073 051073 1 

300574 011074 051074 1 

300575 011075 051075 1 

300576 011076 051076 1 

300577 011077 051077 1 

300578 011078 051078 1 

300579 011079 051079 1 

300580 011080 051080 1 

300581 011081 051081 1 

300582 011082 051082 1 

300583 011083 051083 '1 

300584 011084 051084 1 

300585 011085 051085 1 

300586 011086 051086 1 

300587 011087 051087 1 

300588 011088 051088 1 

300589 011089 051089 1 

300590 011090 051090 1 

*** Record 12 -- PTITLE 

Clothianidin - 1 applications @ 0.224 kg/ha 

*** Record 13 

3 0 1 0 0 

*** Record 15 -- PSTNAM 

Clothianidin 

*** Record 16 

300561 0 1 0.0 0.224 0.99 0.01 

300562 0 1 0.0 0.224 0.99 0.01 

300563 0 1 0.0 0.224 0.99 0.01 

300564 0 1 0.0 0.224 0.99 0.01 

300565 0 1 0.0 0.224 0.99 0.01 

300566 0 1 0.0 0.224 0.99 0.01 

300567 0 1 0.0 0.224 0.99 0.01 

300568 0 1 0.0 0.224 0.99 0.01 

300569 0 1 0.0 0.224 0.99 0.01 

300570 0 1 0.0 0.224 0.99 0.01 

Page 97 of 110 
300571 0 1 0.0 0.224 0.99 0.01 

300572 0 1 0.0 0.224 0.99 0.01 

300573 0 1 0.0 0.224 0.99 0.01 

300574 0 1 0.0 0.224 0.99 0.01 

300575 0 1 0.0 0.224 0.99 0.01 

300576 0 1 0.0 0.224 0.99 0.01 

300577 0 1 0.0 0.224 0.99 0.01 

300578 0 1 0.0 0.224 0.99 0.01 

300579 0 1 0.0 0.224 0.99 0.01 

300580 0 1 0.0 0.224 0.99 0.01 

300581 0 1 0.0 0.224 0.99 0.01 

300582 0 1 0.0 0.224 0.99 0.01 

300583 0 1 0.0 0.224 0.99 0.01 

300584 0 1 0.0 0.224 0.99 0.01 

300585 0 1 0.0 0.224 0.,99 0.01 

300586 0 1 0.0 0.224 0.99 0.01 

300587 0 1 0.0 0.224 0.99 0.01 

300588 0 1 0.0 0.224 0.99 0.01 

300589 0 1 0.0 0.224 0.99 0.01 

300590 0 1 0.0 0.224 0.99 0.01 

*** Record 17 

0 1 0 

*** Record 19 -- STITLE 

"Conant Silt Loam MLRA M-146, Aroostook County, ME" 

*** Record 20 

10 0 001000000 

*** Record 26 

0 0 0 

*** Record 30 

4 188 

*** Record 33 

4 

1 10 1.25 0.341 0 0 0 

0.0009320.000932 0 

0.1 0.341 0.121 4.64 10 

2 16 1.25 0.341 0 0 0 

0.0009320.000932 0 

1 0.341 0.121 4.64 0 

3 6 4 1.4 0.266 0 0 0 

0.0009320.000932 0 

1 0.266 0.116 0.174 0 

4 10 1.6 0.261 0 0 0 

0.0009320.000932 0 

1 0.261 0.111 0.116 0 

***Record 40 

0 

YEAR 10 YEAR 10 

1 

1 ----- 

7 YEAR 

PRCP TCUM 0 0 

RUNF TCUM 0 0 

INFL TCUM 1 1 

ESLS TCUM 0 0 1.0E3 

RFLX TCUM 0 0 1.OE5 

EFLX TCUM 0 0 1.OE5 

RZFX TCUM 0 0 1.OE5 

Page 98 of 110 

YEAR 10 1 
A-VII, Part 5: Modeling of Clothianidin Applications on Grapes 

Key files: 

EECs, 2 applications: 

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 

1961 0.3591 0.3566 0.3471 0.2483 0.1 96 0.05984 

1962 0.3283 0.3267 0.3204 0.3095 0.3024 0.273 

Page 99 of 1 10 
Selected EECs: 

EECs (0.1 exceedance probability), Clothianidin on Grapes (two soil application): 

Ir I I I I I I 11 

EECs for Grapes, single soil application: 

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 

1961 0.1 12 0.1 109 0.1 071 0.1 005 0.09658 0.06849 

Probability 

0.1 

Page 100 of 1 10 

Peak 

1.0701 

96 hr 

1.0623 

21 Day 

0.91612 

60 Day 

0.84872 

90 Day 

0.82327 

Yearly 

0.6532E 
Probabilit 

Y 

Peak 21 Day 60 Day 90 Day Yearly 

Clothianidin, Grapes, inputs, 2 foliar applications: 

CAgrapes 

"~difornia central valley grapes, MLRA-17, rnetfile: W93193.dvf (old: Metl8.met or Metl7.met), 

*** Record 3: 

0.7 0.55 0 17 1 3 

*** Record 6 -- ERFLAG '1 

4 

*** Record 7: 

0.28 0.2 1 10 1 2 354 

*** Record 8 

1 

*** Record 9 

1 0.25 100 70 3 84 79 82 0 200 

*** Record 9a-d 

1 26 

0101 1601 0102 1602 0103 1603 0104 1504 1604 0105 1605 0106 1606 0107 1507 1607 

.360 .410 ,428 .444 .459 ,478 .493 .511 .514 .517 .491 .472 ,463 .462 .471 .471 

.023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 

0108 16080109 1609 0110 16100111 1611 0112 1612 

.470 .470 .479 .481 .483 ,489 .274 .293 .309 .322 

.023 .023 .023 .023 .023 .023 .023 .023 .023 .023 

*** Record 10 -- NCPDS, the number of cropping periods 

30 

*** Record 11 , 

010261 150861 310861 1 

010262 150862 310862 1 

Page 101 of 110 
01 0263 1150863 310863 1 

010264 150864 31 0864 1 

010265 150865 310865 1 

010266 150866 310866 1 

010267 150867 310867 1 

010268 150868 310868 1 

010269 150869 310869 1 

010270 150870 31 0870 1 

010271 150871 310871 1 

01 0272 150872 310872 1 

010273 150873 310873 1 

010274 150874 31 0874 1 

010275 150875 310875 1 

010276 150876 310876 1 

010277 150877 310877 1 

010278 150878 31 0878 1 

old279 150879 310879 1 

010280 150880 310880 1 

010281 150881 310881 1 

old282 150882 310882 1 

01 0283 150883 310883 1 

010284 150884 310884 1 

010285 150885 310885 1 

I 010286 150886 310886 1 

010287 150887 310887 1 

010288 150888 310888 1 

010289 150889 310889 1 

010290 150890 310890 1 

*** Record 12 -- PTITLE 

Clothianidin - 2 applications Q 0.1 121 kglha 

*** Record 13 

60100 

*** Record 15 -- PSTNAM 

Clothianidin 

*** Record 16 

160861 0 2 0.00.1 121 0.99 0.01 

300861 0 2 0.00.1 121 0.99 0.01 

160862 0 2 0.00.1 121 0.99 0.01 

300862 0 2 0.00.1 121 0.99 0.01 

160863 0 2 0.00.1 121 0.99 0.01 

300863 0 2 0.00.1 121 0.99 0.01 

160864 0 2 0.00.1 121 0.99 0.01 

300864 0 2 0.00.1 121 0.99 0.01 

160865 0 2 0.00.1 121 0.99 0.01 

300865 0 2 0.00.1 121 0.99 0.01 

160866 0 2 0.00.1 121 0.99 0.01 

300q66 0 2 0.00.1 121 0.99 0.01 

1608,67 0 2 0.00.1 121 0.99 0.01 

3008;67 0 2 0.00.1 121 0.99 0.01 

160868 0 2 0.00.1 121 0.99 0.01 

3008b8 0 2 0.00.1 121 0.99 0.01 

160869 0 2 0.00.1 121 0.99 0.01 

300889 0 2 0.00.1 121 0.99 0.01 

1608i70 0 2 0.00.1 121 0.99 0.01 

300870 0 2 0.00.1 121 0.99 0.01 

160871 0 2 0.00.1 121 0.99 0.01 

3008P1 0 2 0.00.1 121 0.99 0.01 

160872 0 2 0.00.1 121 0.99 0.01 

300872 0 2 0.00.1 121 0.99 0.01 

160873 0 2 0.00.1 121 0.99 0.01 

300873 0 2 0.00.1 121 0.99 0.01 

160874 0 2 0.00.1 121 0.99 0.01 

300874 0 2 0.00.1 121 0.99 0.01 

160875 0 2 0.00.1 121 0.99 0.01 

Page 102 of 110 
300875 0 2 0.00.1 121 0.99 0.01 

160876 0 2 0.00.1 121 0.99 0.01 

300876 0 2 0.00.1 121 0.99 0.01 

160877 0 2 0.00.1 121 0.99 0.01 

300877 0 2 0.00.1 121 0.99 0.01 

160878 0 2 0.00.1 121 0.99 0.01 

300878 0 2 0.00.1 121 0.99 0.01 

160879 0 2 0.00.1 121 0.99 0.01 

300879 0 2 0.00.1 121 0.99 0.01 

160880 0 2 0.00.1 121 0.99 0.01 

300880 0 2 0.00.1 121 0.99 0.01 

160881 0 2 0.00.1 121 0.99 0.01 

300881 0 2 0.00.1 121 0.99 0.01 

160882 0 2 0.00.1 121 0.99 0.01 

300882 0 2 0.00.1 121 0.99 0.01 

160883 0 2 0.00.1 121 0.99 0.01 

300883 0 2 0.00.1 121 0.99 0.01 

160884 0 2 0.00.1 121 0.99 0.01 

300884 0 2 0.00.1 121 0.99 0.01 

160885 0 2 0.00.1 121 0.99 0.01 

300885 0 2 0.00.1 121 0.99 0.01 

160886 0 2 0.00.1 121 0.99 0.01 

300886 0 2 0.00.1 121 0.99 0.01 

160887 0 2 0.00.1 121 0.99 0.01 

300887 0 2 0.00.1 121 0.99 0.01 

160888 0 2 0.00.1 121 0.99 0.01 

300888 0 2 0.00.1 121 0.99 0.01 

160889 0 2 0.00.1 121 0.99 0.01 

300889 0 2 0.00.1 121 0.99 0.01 

160890 0 2 0.00.1 121 0.99 0.01 

300890 0 2 0.00.1 121 0.99 0.01 

*** Record 17 

010 

*** Record 18 

0 0 0.5 

*** Record 19 -- STITLE 

"San Joaquin loam, Hyd grp C" 

*** Record 20 

340 001002000 

*** Record 26 

0 0 0 

*** Record 27 -- irrigation 

1 0.1 0.55 0.4 

*** Record 30 

4 188 

*** Record 33 

2 

1101.840.21 0 0 0 

0.0009320.000932 0 

0.1 0.21 0.1 0.72 0 

2 330 1.6 0.28 0 0 0 

0.0009320.000932 0 

30 0.28 0.15 0.16 0 

***Record 40 

0 

YEAR 10 YEAR 10 

1 

1 ----- 

7 YEAR 

PRCP TCUM 0 0 

RUNF TCUM 0 0 

INFL TCUM 1 1 

ESLS TCUM 0 0 1.OE3 

RFLX TCUM 0 0 1.OE5 

YEAR 10 1 

Page 103 of 110 
EFLX TCUM 0 0 1.OE5 

RZFX TCUM 0 0 1.OE5 

Clothianidin, Grapes, inputs, 1 soil application: 

CAgrapes 

"California central valley grapes, MLRA-17, metfile: W93193.dvf (old: Metl8.met or Metl7.met), 

*** Record 3: 

0.7 0.55 0 17 1 3 

*** Record 6 -- ERFLAG 

4 

*** Record 7: 

0.28 0.2 1 10 1 2 354 

*** Record 8 

1 

*** Record 9 

1 0.25 100 70 3 84 79 82 0 200 

*** Record 9a-d 

I 26 

0101 1601 0102 1602 0103 1603 0104 1504 1604 0105 1605 0106 1606 0107 1507 1607 

.360 .410 ,428 .444 .459 .478 .493 .511 .514 .517 .491 .472 .463 .462 .471 .471 

.023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 

0108 16080109 16090110 16100111 1611 0112 1612 

.470 .470 .479 .481 .483 .489 .274 .293 .309 .322 

.023 .023 ,023 .023 .023 .023 .023 .023 .023 .023 

*** Record 10 -- NCPDS, the number of cropping periods 

30 

. *** Record 11 

010261 150861 310861 1 

010262 150862 310862 1 

010263 150863 310863 1 

010264 150864 310864 1 

010265 150865 310865 1 

010266 150866 310866 1 

010267 150867 310867 1 

010268 150868 31 0868 1 

010269 150869 310869 1 

010270 150870 310870 1 

010271 150871 310871 1 

01 0272 150872 31 0872 1 

010273 150873 310873 1 

010h74 150874 310874 I 

010275 150875 310875 1 

010276 150876 310876 1 

010277 150877 310877 1 

010278 150878 310878 1 

010279 150879 31 0879 1 

010280 150880 310880 1 

010281 150881 310881 1 

010b82 150882 310882 1 

010b83 150883 310883 1 

010284 150884 310884 1 

010285 150885 310885 1 

010286 150886 310886 1 

010h87 150887 310887 1 

010288 150888 310888 1 

010289 150889 310889 1 

010290 150890 310890 1 

*** Re'cord 12 -- PTITLE 

PE4-Grape-050608d - 1 applications Q 0.2242 kglha 

*** Record 13 

30100 

Page 104 of 110 
*** Record 15 -- PSTNAM 

PE4-Grape-050608d 

*** Record 16 

010261 0 1 0.00.2242 0.99 0.01 

010262 0 1 0.00.2242 0.99 0.01 

010263 0 1 0.00.2242 0.99 0.01 

01 0264 0 1 0.00.2242 0.99 0.01 

01 0265 0 1 0.00.2242 0.99 0.01 

010266 0 1 0.00.2242 0.99 0.01 

010267 0 1 0.00.2242 0.99 0.01 

010268 0 1 0.00.2242 0.99 0.01 

010269 0 1 0.00.2242 0.99 0.01 

010270 0 1 0.00.2242 0.99 0.01 

010271 0 1 0.00.2242 0.99 0.01 

01 0272 0 1 0.00.2242 0.99 0.01 

01 0273 0 1 0.00.2242 0.99 0.01 

010274 0 1 0.00.2242 0.99 0.01 

010275 0 1 0.00.2242 0.99 0.01 

01 0276 0 1 0.00.2242 0.99 0.01 

01 0277 0 1 0.00.2242 0.99 0.01 

010278 0 1 0.00.2242 0.99 0.01 

010279 0 1 0.00.2242 0.99 0.01 

Old280 0 1 0.00.2242 0.99 0.01 

01 0281 0 1 0.00.2242 0.99 0.01 

010282 0 1 0.00.2242 0.99 0.01 

010283 0 1 0.00.2242 0.99 0.01 

01 0284 0 1 0.00.2242 0.99 0.01 

old285 0 1 0.00.2242 0.99 0.01 

01 0286 0 1 0.00.2242 0.99 0.01 

01 0287 0 1 0.00.2242 0.99 0.01 

01 9288 0 1 0.00.2242 0.99 0.01 

010289 0 1 0.00.2242 0.99 0.01 

010290 0 1 0.00.2242 0.99 0.01 

*** Record 17 

010 

*** Record I9 -- STITLE 

"San Joaquin loam, Hyd grp C" 

*** Record 20 

340 001002000 

*** Record 26 

0 0 0 

*** Record 27 -- irrigation 

1 0.1 0.55 0.4 

*** Record 30 

4 188 

*** Record 33 

2 

1101.840.21 0 0 0 

0.0009320.000932 0 

0.1 0.21 0.1 0.72 0 

2 330 1.6 0.28 0 0 0 

0.0009320.000932 0 

30 0.28 0.15 0.16 0 

***Record 40 

0 

YEAR 10 YEAR 10 YEAR 10 1 

1 

1 ----- 

7 YEAR 

PRCP TCUM 0 0 

RUNF TCUM 0 0 

INFL TCUM 1 1 

ESLS TCUM 0 0 1.OE3 

RFLX TCUM 0 0 1.OE5 

Page 105 of 110 
EFLX TCUM 0 0 1.OE5 

RZFX TCUM 0 0 1.OE5 

Page 106 of 110 
PE4 lnput screens 

Figurel4. PE4 Input screen for clothianidin cotton seed 

treatment. 

PE4 lnput screen for clothianidin cotton seed treatment. 

Page 107 of 1 10 
Figure 16. PE4 Input screen for clothianidin on potatoes, 3 late-season 

applications totalling 0.2 Ib ail acre. 

FigurelS. PE4 Input screen for clothianidin sorghum seed 

treatment. 

Page 108 of 110 
Figure 18. PE4 lnput screen for clothianidin on potatoes, single soil 

application of 0.2 Ib ail acre. 

Figure 17. PE4 lnput screen for clothianidin on potatoes, 3 early-season 

applications totalling 0.2 Ib ail acre (yielded lower EECs than with 3 lateseason applications, therefore not used in the ecological risk assessment). 

Page 109 of 110 
Figure 19. PE4 Input screen for clothianidin on grapes, 2 late-season 

applications totalling 0.2 Ib ail acre. 

Page 110 of 110