UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September28,2005 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 ScientistJWaterModel 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 allowedto be sprayed on blooming, pollen-shedding,or nectar producing parts of plants. Because of this, EFED is recommendingbee 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 RQbased 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 seedtreatment) 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 appearsto be also, there is a possibility of adverse effectsto beneficial insects such as honey bees from products containing either compound.
Based on proposed application rates and uses, acute and chronic risks to smallbirds and

T mammals are unlikely, except for endangeredmammals should exposure actually occur. In addition, considering the mode of agricultural practice of drilling seeds duringplanting, 

### 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 terrestrialplants (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 accumulatein soils from year to year with repeated uses. The major route of dissipation for clothianidin would appearto be photolysis if exposure to sunlight occurs (e.g.,the measured aqueousphotolysis half-life was <1 day and aerobic half-lives were 148to 1155days). Major degradates include TMG, MNG, and TZNG. 

### Risk to Endangered Species Based on available information, clothianidinmay 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 correspondingto 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 1in 7.21 x 1013for smallmammals and 1in 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 PotentialEndocrine Disruptors EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by FQPA, to develop a screeningprogram to determinewhether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect producedby a naturally-occurring estrogen, or other such endocrine effects as the Administratormay designate." Following the recommendationsof its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientificbasis for

I including, as part of the program, the androgen- and thyroid hormone systems,in addition to the estrogen hormone system. EPA also adoptedEDSTAC'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 substancemay have an effect in humans, FFDCA authorityto require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systemsmay be addedto the Endocrine Disruptor Screening Program (EDSP).When the appropriate screening and or testing protocols being consideredunder the Agency's Endocrine Disruptor Screening Program have been developed, clothianidinmay be subjectedto additional screening and or testing to better characterize effects related to endocrine disruption. Data suggests that clothianidin cpuld be a candidate for additional screening andlortesting to better characterize effects related to endocrine disruption. Effects in avian species included significant decreases in eggshell thickness. Effects in mammalian reproduction studies included decreasedbody weight gains and delayed sexual maturation (males only), decreased absolute thymus weight in F1pups (both sexes), increased stillbirths (Fl and F2 litters), decreased sperm mobility and increased number of sperm with detatchedheads (F1 and F2 litters). 

### OutstandingData Requirements Environmental Fate: 162-4 Aerobic Aauatic metabolism Study. Based on the additional information submittedby 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 clothianidinto 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 reviewedby EFED (Turfgrass, Tobacco, Apples, Pears, and Ornamentals), this cheinical can be directly applied to the soil surface/foliageat 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 greaterthan the use as a seed treatment. Therefore, there is a need for a better understandingof the fate of clothionidinin the aerobic aquatic environment.
2. The fate of the thiazolyl ring was not monitored in the previously-reviewedaerobic aquatic metabolism study (MRID 45422324) because the test substancewas labeled on the nitroimino side chain. Therefore, the fate of the thiazolyl ring remains unknown. The fate guidelinesrecommend to use the ring-labeled test substance.
3. A well-designednew aerobic aquatic metabolism study is deemed critical for EPA to fully assess the risk of clothionidin in the aquatic environment.
166-1 Small-ScalePros~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 forthe Seed Treatment of Clothianidin 600FS on Corn and Canola" datedFebruary 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 applicationof 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 clothianidinin the environment, a small-scale prospective groundwater monitoring study will provide additional fate information on the better understandingof this chemical in the environment and improve the certainty of the risk assessment. 

### Ecological Effects: The database available for clothianidin to support the assessmentwas 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),D2953181. The protocol title is: An Investigation of the PotentialLong-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 RegulatoryAgency (PMRA) completed ajoint 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 thisjoint review. The following ecological studies for clothianidin are still outstanding and need to be submitted. 

### OPPTS 850.1735: Whole SedimentAcute 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 SedimentAcute Toxicity Invertebrates, Estuarine and Marine

# - Testing with estuarinelmarineinvertebratesusing the TGAI is required for clothianidinbecause clothianidinis toxic to aquatic invertebrates, persistent in the environment, binds to sediment over time. and the end-use product is expected to reach the marinelestuarineenvironmentbecause of it use in coastal counties. 

### Field Test for Pollinators (141-5): The possibility of toxic exposure to nontarget pollinators through the translocation of clothianidinresidues 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 clothianidinresidues on the seed surface. This in turn would allow a refinement of exposure estimates and environmental concentration values (EECs). 

### Uncertainties The uncertainties associatedwith clothianidin exposure in the environment are mainly focused in these areas; 1) accumulation of clothianidinin soils after repeateduses and the potential for transport/migrationto 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 pollinatorsthrough the translocation of clothianidin residues to blooming, pollen-shedding or nectar-producingparts 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 assumedto occupy either the treated field or adjacent areas receiving pesticide at a rate commensuratewith the treatment rate on the field. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumedthat 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 assessmentsfor spray applicationsof pesticidesusually consider dietary exposure alone. 

### EFED Label Recormnendations
Label Recormnendations Manufacturing 

### UseProduct Do not discharge effluent containingthii product into lakes, streams,ponds, estuaries, oceans, or other waters unless in accordancewith 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 treatmentplant authority. For guidance contact your State Water Board or Regional Office of the EPA.End 

### UseProducts 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 specifiedon the label. This chemical has properties and characteristics associatedwith chemicals detected in ground water. The use of this chemical in areas where soils are permeable, particularlywhere 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 surfacemay 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 followingtreatment. Do not apply this product to blooming, pollen-shedding or nectar-producingparts of plants if bees may forage on the plants during this time period, unless the applicationis made in response to a public health emergency declaredby 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 SITEIS 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 shouldbe observed.

### Data Requirement Tables

161-1 Hydrolysis 45422317 Core
161-2 Photodegradation in 45422318 Water 45422319 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 45422312 45422313 45422314 45422315 45422316 Laboratory Volatility NIA Core Ancillary Supplemental Supplemental Supplemental Supplemental Waived Waived Field Volatility NIA NIATerrestrial 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 WaivedReservedYes

Reserved

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

Data Requirement MRID # Classification Is more data needed' Guideline# 71-1 Avian acute oral LD, (mallard duck) 45422417 (japanesequail) 45422418 Core Supplemental
71-2 Av~an subacute dietaryLC,, (bobwhitequai)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 Yes not applicable
Estuarinelmarinefish acute LC,, (sheepsheadminnow) 45422411 Supplemental

Estuarinelmarineinvertebrate acute EC,, (easternoyster) 45422404 Core (mysid) 45422403 Core

45422413 Supplemental Freshwater fish early life stage (fathead minnow)

Freshwater invertebrate life cycle (daphnia) 45422412 Supplemental

Estuarinelmarinelife cycle (mysid) 45422405 Core
Acute Freshwater Invertebrate Sediment Toxicity

TGAI Yes
No not applicable not applicable NA Aquatic Field StudyTable of EcologicalToxicity 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) 45422712-13 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 EcologicalRisk Assessment for the Registration of CLOTHIANIDINfor 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/ChemicalProperties 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 

### t7 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 96I. Executive Summary
The registrant, Arvesta Corporation, is submitting clothianidinto be used on potatoes and grapes and also as a seed treatment on sorghum and cotton. This risk assessmentprimarily 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 15gmammals and freshwater invertebrateswere 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 (contactLD,, 

### =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 producingparts of plants. Pesticides with residue toxicity greaterthan 12hours will kill bees in substantialnumbers 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 showedthat use of clothianidin to rape (canola) results in detectable levels (ranging from 1.0 to 8.6ppb) 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 sampledmore than 60 days after the clothianidintreated 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 likelyhoodof clothianidin residuesbeing carriedback to the hives resulting in accumulationof the pesticide thus adversely effecting the colonieshealth 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 treatmentto sunflowers afterbeekeepers noted that honeybees were showing modificationsof behavior that were reflected in foraging and orientation that eventually resulted in a drastic changein hive con&tions and bee survival. Further researchby the Le Centre Technique Interprofessionaldes Oleaginenx(CETIOM) confirmed imidacloprid toxic residue levels in the sunflower nectar. This action has prompted France to ban the use of imidacloprid for sunflowerseed treatment.EFED still has other uncertainties associatedwith seed treatment uses of clothianidin. These uncertainties are compounded with the new proposed uses of clothianidin. The earlierbee field studies for clothianidin demonstratedthat 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 producingparts of plants. However, EFED is uncertain about what would happen when foliar spray or granular applications of clothianidin are made prior to bloom. How likleycould systemic clothianidin be translocated to the nectar orpollen producing parts of plants when applied as spray, as a granular or as a seed treatment? From the seed treatment field studyresults, it seems likely such a translocation would occur. If this were to occur, how much clothianidincan 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 clothianidintreated 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 1in 7.2 1 x 1013for 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 assessmentsto fill data gaps needed for a suitable screening level risk assessment. As part of the Tier 1 terrestrial assessment, EFED modeled exposure concentrationsof clothianidin to nontarget terrestrial plants and animals following the proposed turfgrass application rates providedby the registrant. For terrestrialbirds and mammals, estimates of initial levels of clothianidin residues on various food items, which may be contacted or consumedby wildlife, were determinedusing the Fletcher nomogram followedby a first order decline model. Avian acute and chronic RQs were below LOCs (0.5 to 0.1 and 1, respectively). Mammalian chronicRQs do not exceedLOCs (highestRQ =0.64 for clothianidin's use on turf). The risk concerns for non-endangeredaquatic specieswere evaluated in a Tier 

### II assessment using the PRZMIEXAMS model to predict surfacewater clothianidin concentrations. EFED identified spray drift and runoff to adjacent bodies of water as the most likely sources resultingin clothianidin exposure to nontarget aquatic organisms. The freshwater fish LC,,s (ranging from >I05 to 

### > 117ppm) 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 impreciseLC,, levels, which exceed predicted clothianidinEECs, EFED does not expect an acute risk to freshwater fish. Chronic exposure from the proposed clothianidinusage 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 suggeststhat toxic risk to estuarinelmarinefish 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 acuteLOCs. 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 1in 5.76 

### x lo7for freshwater invertebrates. The RQ for 15g mammals slighty exceeded (RQ = 0.12) the endangered speciesLOC (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 1in 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 suggeststhat clothianidin could be a candidate for additional screening and/ortesting to better characterize effects related to endocrine disruption. Effects in avian species included significant decreases in eggshell thickness. Effects in mammalian reproduction studies included decreasedbody weight gains and delayed sexual maturation (males only), decreased absolutethymus weight in F1pups (both sexes), increased stillbirths 

### (F1 and F2 litters), decreased spermmobility and increasednumber of sperm with detatchedheads (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 potentialto leach to groundwater, be transportedvia runoff to surfacewater bodies, and could accumulate in soils from year to year with repeated uses. The major route of dissipation for clothianidin would appearto 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 1155days). Major degradates include TMG, 

### MNG, and TZNG.
The uncertainties associatedwith clothianidin exposure in the environment are mainly focusedin these areas; 1) accumulationof clothianidinin soils after repeateduses and the potential for transportlmigrationto 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 pollinatorsthrough the translocation of clothianidin residues to blooming, pollen-shedding or nectar-producingparts 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 theapplication rate, reduction in the number of applications (especially in the presence of pollinators or nesting birds), and increasing the intervalbetween applicationsmay 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 performedto 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 effectsto the queen. Additional modeling shouldbe done to sirmulate the potential affects of repeateduses in order to determineif reproduction and development are affected in birds, mammals, and soil invertebrates. 

### 11. PhysicaVChemicalProperties Characterization A summary of selectedphysical and chemicalparameters for clothianidin is presentedin 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 1.61g/ml (at 20°C), 

### 1.59 g/cm3 0.327glL (at 20°C)Solubilityin other solvent dichloromethane 

### 1.32 methanol 6.26 octanol0.938



### Pesticide Type, Class, Mode ofAction 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 receptorsbut not inhibitingAChE. Clothianidin, like other neonicotinoids, is an agonist of acetylcholine, the neurotransmitterthat stimulatesthe nAChR.In insects, neonicotinoids cause symptoms similar to that of nicotine. The symptoms appearrapidly as increased restlessness followedby 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 summaryof the rates from the various product labels for all proposed applications.



### IV. Problem Formulation The planning stagefor 

### an ecological risk assessment entails initial discussionsbetween 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 (usesof 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 analysisplan and rationale for developing a risk assessment for clothianidin is an iterativeprocedure for determiningif 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 formulationwhich is an explicit statement of the characteristic of the environmentto be protected is encompassedin 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 50WDG BelayTM 16WSG; ClutchTM 50WDG 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. Seedtreatment

Seed treatmentan ecosystem. Relative to the proposed use of clothianidin, EFED initiallyhad concerns for risk to aquatic organisms due to high persistence and potential mobility of clothianidin to surfacewaters. In the case of this assessment, EFED relied on the clothianidin hazard assessmentwhich considers
I standard single chemical toxicity testing (acute and chronic endpoints) submittedby the registrant and reviewedby 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 EcologicalEffects," and represent registrant submitted data. The effects databaseis mostly complete for freshwater and estuarinelmarine aquatic organisms and thus is suitablefor 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 andlorpore-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 includedunder the section "Characterization of EcologicalEffects," and represent registrant submitted data. Although EFED does not conduct RQ based risk assessmentson beneficial insects, there is potential for direct toxic effectsto honey bees as suggestedby 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 invertebratesvia acute toxicity. (b). Direct effects on reproductionto 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 accumulatein soils with repeated uses. Thus, the initial emphasis of the screening risk assessmentwas primarily about possible risk to freshwater and estuarinelmarine fish and invertebrates as well as to terrestrial birds, mammals, and invertebrateswhich may be exposed to residual clothianidin afterspray and seed treatment applications. 

### Tier I Aquatic Assessment Since clothianidinis 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 inthe diversity and abundanceof benthic organisms,which in turn could affect fish populations resulting in possible adverse effectsto 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 11assessmentusing 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 consideredin 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 clothianidinwith an acute 48-hr EC,, of 64mg/L (NOEC of 11.2mg/L) 

### [MRID 454224011. All of the degradateswere less toxic than clothianidin to Chironomus riparius (48-hrEC,,'s ranging from >83.6 - >I02ppm). TZNG was also less toxic than clothianidin but more toxic than the other degradateswith an EC,, of 0.386 ppm) 

### [MRD454224141. Aquatic fate studies indicated that TMG was the primary degradateto accumulate significantlyin the aerobic aquatic studies (which were not strictly aerobic in the sediment where the TMG was found) and that no degradatewas found to accumulate significantly in the anaerobic aquatic studies.
The Tier 11level 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 relationshipsbetween 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 developedusing several models which are based on the maximum application rate of clothianidin for the proposed uses and the physical and chemical characteristicsof clothianidin. These RQs were then comparedto the LOC's used by EFED for determiningpotential risk to non-target organisms and the subsequentneed for possible regulatory action.

I I 

### Tier 

### I TerrestrialAssessment 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/chemicalproperties of clothianidin,its fate and disposition in the environment, and mode of application in order to develop a conceptualmodel (Figure 1.0). This scenario depicts ground applicationto grapes and potatoes in addition to seed treatment of sorghum and cotton. Laboratory and field studies indicate that clothianidinishighly persistent (aerobic soil metabolism and terrestrial field dissipation half-livesranging from half a year to severalyears) 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 effectsto soil communities due to the persistence/accumulation of clothianidin in soils fromrepeated uses and the potential for reduced crop yield from the impact to pollinators.
As part of the Tier I terrestrial assessment, EFED modeled exposure concentrationsof clothianidin to nontarget terrestrial plants and animals following the proposed application rates provided by the registrant. For terrestrialbirds and mammals, estimates of initial levels of clothianidin residues on various food items, which may be contacted or consumedby wildlife, were determined using the Fletcher nomogram followedby a first order decline model. LD50 sqlft estimates of risk were calculated for the seed treatment applications.
In order to emphasize the relationshipsbetween the stressor (clothianidin)and the assessment endpoints, and to evaluate the potential risk to terrestrial organismsfrom 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 developedusing several models which are based on the maximum application rate of clothianidin for the proposed uses and the physical and chemical characteristicsof clothianidin. These RQs were then compared to the LOC's used by EFED for determiningpotential 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 relationshipsbetween each other and site characteristics.The objective is to provide theingredients 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 appearsto be a persistent compoundunder most field conditions. Based on analysis of the laboratory studies alone, the major route of dissipation for clothianidinwould 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 1155days). Although photolysis appears to be much more rapid than other avenues of degradationldissipationof clothianidin in the laboratory studies, the very slow rate of dissipation that was observed in field studies suggests that photolysis probably is not significantunder most actual-use conditions. Photolysismay be quite important in surface waters if residues have reached'clear bodies of water and are in solutionrather than bound to sediment. Clothianidinis stable to hydrolysis at environmentalpHs and temperatures. Degradation is also relativelyrapid 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 studieshave confirmed that compounds with a similar combinationof mobility and persistence characteristics have a potential to leach to ground water at some use sites. Volatilization is not expectedto 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 1,155days (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 studyto accurately calculatethe degradation rate over the 1-year studyperiod (r2 = 0.05).
Under anaerobic aquatic conditions, metabolic degradation occurred relatively quickly (half-life of 14days in water; 37 days in sediment; 27 days overall). Clothianidin was <1% of the applied in the water at and after 120days and was ~2.0% in the silt loam sediment at and after 183 days. No major degradateswere isolated; clothianidinwas convertedprimarily to soil-bound residues. Clothianidin photodegradedwith half-lives of c1 day in sterilebuffer solutionin 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 surfacewater-source drinktngwater represents uncertainty with regard.to the importance of photodegradation in the long-term fate of clothianidin in natural waters. In the laboratory, clothianidinphotodegraded in sterile aqueous pH 7 buffer solutions with a half-life of 6.2-6.8 hours, based on a 12-hourlightll2-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 sunlight115hours 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, clothianidinphotodegraded with a half-life of 8.2 days based on continuous irradiation (estimatedto be equivalentto 34.2 solar summer days in Phoenix, AZ); degradation was not significant in the dark. At study termination (equivalent to 71days 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 laboratorybatch equilibrium studes, clothianidinhad medium mobility in a US sandy loam soil and high mobility in US loamy sand and clay loam and German sand and sandyloam soils. In batch equilibrium studiesusing the same soils and similar conditions,MNG was very highly mobile, TZMU was highlyto very highly mobile, TZNG was moderatelymobile, 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 expectedto 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 1,386days (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. Clothianidinwas generally not detectedbelow the 45 cm soil depth except at one site, where it moved into the 45-60 cm depth. No degradateswere detected at rl0%of the applied, and degradateswere generally only detected in the 0-'15cm soil layer. Hohever, in many cases most of the parent remained untransformedat the close of the study; further accumulationof degradates could have occurred. Degradatesthat 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 clothianidinunder field conditions (MRIDS 45422331 and 45422508). These studies were conducted in the Federal Republic of Germany and were apparently designed to fulfill certain Europeanregulatory 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 undegradedclothianidin. The loss of radioactivitywas attributedby the authors to mineralizationof clothianidin, since I 1% of the total residues were detected in the leachate. Clothianidinwas not detected in the leachate. There was also a significantamount 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 applicationof 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 clothianidinmay occur in followingyears 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 groundwateras 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 compoundsmay be mobile and persistent.
Tier 11EECs for clothianidinwere calculatedusing PRZMIEXAMS. PRZM/EXAMS is a screening model designedto 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 45422331)there was no parent clothianidin detected in the leachate. The degradates were detectedin small quantities in the leachate. In one study, MNG and NTG were detectedin leachate samples; in the other study none of the degradates in the leachate were identified. Clothianidinwas 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 primarilyundegraded clothianidin. These results highlight the potential for very high persistence of clothianidin and some degradates and the possibility of leachingto 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 degradatesof clothianidin is constrainedby the high persistence of clothianidin parent and the concomitant lack of significant accumulation of any specificproduct in most laboratory and field studies. Major degradates detectedin one or more of the aqueous photolysis studies which might or might not be importantunder 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 the10 soils used for aerobic metabolism investigation (54 to 95% of the parent compoundremaining 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 significantlyin the aerobic aquatic studies (which were not strictly aerobic in the sedimentwhere the TMG was found). In the anaerobic aquatic study,no degradatewas 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 conductedfor 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 relativelyhigh soil mobility and low adsorption to soil and sediment) including the degradatesin exposure modeling would not likely significantly increase the total exposure level estimates.
Estimated Environmental Concentrations (EECs) for Aquatic Ecological Effects Table Va summarizesthe input values used in the PRZM/EXAMS model. Fate parameters were obtained from studies submittedby the registrant and modified, if necessary, according to the Guidance for Selecting Input Parameters 

### inModeling 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 13of 110 Aquatic photolysis half-life photolysishald-lifebecause of demonstrated persistencein water and on soil surfaceexposed to

Organic carbon partition coefficient (KOC) Soil aerobic metabolichalfLife (days) Aquatic metabolic half-life (days) 188

744*

1,488 45422319, 45422321 (water)

MRID 45422311

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-lifeused since there was no acceptable aerobic aquatic studyTable 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 andMammalian Species An extensive assessment of the potential exposure and risk to avian guideline species exposed to clothianidinby oral intubation or in the diet concluded that clothianidinwas moderately toxic to bobwhite quail on an acute basis 

### (LD,,> 200 mglkg) and non-toxicto the mallard duck and bobwhite quail on a sub-acute basis (5 day 

### LC,, >5040 ppm and 5230 ppm), respectively. A Tier 

### I screening assessmentbased 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 applicationwould not present a risk to avian species.
The submitted chronic toxicity data show that exposure of 525 ppm of clothianidinin 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 determineif birds are at risk from repeated uses of clothianidin. Likewise, an assessment of potential exposure and risk to small mammals exposed to clothianidinby the oral route suggeststhat clothianidin is moderately toxic to smallmammals onan acute oral basis (mouseLD,, = 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 15gmammals 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 1in 7.21 x 1013 for small mammals. Reproduction studies in rats indicate that concentrationsof 500 ppm clothianidinresulted in increased stillbirths and delayed sexual maturation in males. Developmental studiesin 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 orburrow in the soils and thus, be subject to repeated or continuous exposure to the pesticide, additional modeling shouldbe done to determineif 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 invertebratesusing 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 clothianidinhas the potential to be highly toxic on both a contact and an oral basis (contactLD,, 

### =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 - >I53pgbee). One honey bee field study 

### (MRID # 45422435) showedthat mortality, polleh foraging activity, and honey yield were negatively affectedby residues of clothianidin; howeyer,residues were not quantified in this study. Anotherhoney bee field study 

### (MRID 45422440) showed that pollen treated with clothianidin at a measured concentration level up to 19.7pg a.i./kgproduced no significant adverse effectsto mortality, foraging activity (including pollen and honey collection), comb production,honey storage behavior,population growth (includingegg, 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 could1not be performed.
Pesticides toxic to honey bees require bee precautionary labeling on all end-use formulations and registrants are required to submit data in accordancewith 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 observationswere also

Page 16 of 110made. 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 determinedto be highly hazardous to honey bees. Results indicate that clothianidin, as V-10066, should not be appliedto blooming, pollinating, or nectar producing parts of plants. Subchronic invertebrate toxicity studies showed that clothianidin adversely affectedearthworm mortality and body weight (LC,, = 15.5ppm) and its degradatesreduced 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 calculatedby dividing exposure estimatesby ecotoxicity values, both acute and chronic.

RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteriaused by OPP to indicate potential risk to non-target organisms and the need to considerregulatory action. The criteria indicate that a pesticide used as directedhas 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 chronicrisks 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 ecotoxicityvalues derived from the results of short-term laboratory studiesthat assess acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and mammals) (3) EC50 (aquaticplants and aquatic invertebrates) and (4) EC25 (terrestrial plants). An example of a toxicity test effect level derived from the results of long-term laboratory studiesthat assess chronic effects is: (1) NOAEC (birds,

2 RT,, is the residual time requiredto reduce the activity of the test material and bring bee mortality down to 25% in cage test exposuresto field-weathered spray deposlts (Mayerand Johansen, 1990). The time period determinedby this toxicity value is consideredto be time that the test materlalis expectedto 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 110fish 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 RestrictedUse EECLC50 or LD5OIsqftor LD5OIday (or LD50 < 50mglkg) 0.2 Acute Endangered Species EECILCSO or LDSOlsqft or LDSOlday 0.1 Chronic Risk EECNOAEC 1 WildMammals: Acute High Risk EECKSOor LDSOIsqft or LD5OIday 0.5 Acute RestrictedUse EECfLC50 or LDSO/sqft or LD501day (or LD50 < 50mgkg) 0.2 Acute Endangered Species EEC/LCSO or LDSOlsqft or LDSOIday 0 1 Chronic Risk EEC/NOAEC 1
EEC=abbreviationfor Estimated EnvironmentalConcentration (ppm) on avian/mammalianfood items

m&ft2 ma of toxicant consumedlday LD50 * wt. ofbird LD50 * wt. ofbird



### Table V1.b. 

### Risk Presumptions for Aquatic Animals Risk Presumption RQ LOC
Acute High Risk Acute RestrictedUse 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 Terrestrialand Semi-AquaticPlants: 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 (freshwaterand estuarinelmarinefishes and invertebrates)can be exposed to clothianidinby spray drift and runoff into surface water. 

### Fresh water Fish Acute and chronic risk quotients are tabulated in Table V1.d. An analysisof the acute test results show there were no mortalities or effects at the indefiniteLC,,s shown and, though indecisive, these acute toxicity values are well above predicted EECs. Because of this, EFED did not calculate acuteRQ values for the proposed uses. EFED does not expect risk to freshwater fish. Chronic exposure from the proposed clothianidinusage patterns should not pose directriskto freshwater fish either. The chronic NOAEC for freshwater fish is 9.7ppm. These predicted exposure levels arebelow levels triggering a chronic risk to freshwater fish.

Page 19 of 110Potato (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 (0.02x 1) Rainbow >I05 NIA 0.153 NIA 0.00 NIA trout Fathead Minnow N/A 9.7 NIA 0.143 NIA 0.00



### FreshwaterInvertebrates Page 20 of 1 

### 10The acute and chronic risk quotients are tabulated in Table V1.e. EFED's evaluation of the calculatedRQ 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 appearto be below EFED's 

### LOC, suggestinglow 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 = 0.022ppm Daphnia magnia NOAECILOAEC = 0.04210.12 ppm reproductiveeffects

Page 22 of 110

### Estuarine andMarine 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 (0.1x 2) Sheepshead >93.6 N/A 1.070 0.00 N/A Sorghum seed (0.02x 1) Sheepshead >93.6 N/A 0.044 0.00 N/A Cotton seed (0.02x 1) Sheepshead >93.6 N/A 0.153 0.00 N/A 

### Estuarine andMarine 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). ChronicRQ values (RQs ranged from 0.0to 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 (0.1x 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 110

### Terrestrial Risk Quotientsand 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 chronicRQs were less than the LOCs (0.5to 0.1 and 1,respectively). However, the mammalian acute RQ (RQ 

### = 0.12) for 15g mammals slightlyexceeded the endangered speciesLOC of 0.1. Mammalian chronic RQs did not exceed chronic LOCs forboth 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 1app 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 (1000g) 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 onbobwhite qua11 acute and chronic toxicity values. Mammalian RQsbased on acute mouse toxicity values. Table V1.i Avian Acute Risk Quotients for SingleApplications of Clothianidin Treated Seed Based on a Japanese Quail (Coturnixcoturnix japonica)
SitdApplication Method Pounds Planted Seed per Acre3 Seed Treatment (lb dl00 lb seed) Row width (feet)Cottona/In-furrowIncorporated 10 0.22 0.1Sorghumb/In-furrowIncorporated 9 0.25 0.1 Page 24 of 110 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 9,3261 Exposed =App. Rate (lbs ai/A)* 453,590 mgllbs 

### * % (decimal) on surfacel[linearft 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 seedlseedsper lb 

### * 453,590 mg/lb 5 Number of Seeds Consumed to Reach LD50 = [LD5O(mg ailkg) 

### * Weight of the Animal (g)/1000 (g/kg)]lmgai 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 15inch row spacing or 34,848 linear ft of row per acre

Page 25 of 110 Mammalian Acute Risk Quotients based on LD50 sq ft for SingleApplications of Clothianidin Treated Seed Based on a Mouse

SiteIApplicat ion Method Pounds Planted Seed per Acre3 Seed Treatment (lb ail100lb seed) Row width (feet)Cottona/InfurrowIncorporated 10 0.22 0.1Sorghumb/InfurrowIncorporated 9 0.25 0.1 1 Exposed =App. Rate (lbs ai/A)* 453,590 mg/lbs 

### * % (decimal)on surface/[linearft 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 0.2exceeds 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 8,576RQ greater or equal to 0.1exceeds 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)/100lb seedlseedsper lb 

### * 453,590 mgllb 5 Number of Seeds Consumed to Reach LD50 = [LD5O(mgailkg) 

### * Weight of the Animal (g)/1000 (g/kg)]/mg ai per I seed 6 Incorporationeffieciency:Banded(coveredwith specifiedamount of soil), in-furrow, drill or shanked-in = 99% Side-dress, banded or broadcst (all mixed or lightly incorporatedwith 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 andPlants
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 contactLD,, = 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 indicatethat clothianidin residues may affect foraging behavior. Data from studies determiningthe toxicity of residues on foliage indicate that clothianidin shouldnot be applied to blooming, pollinating or nectar producingparts of plants because clothianidinwill 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 appearto present risk to terrestrialplants (seedling emergenceEC,, 

### >0.2 lbs ai/A; vegetativevigor EC25 

### >0.2 lbs ai/A). In addition, it does not appear to present risk to aquatic vascularplants (Lemna gibba EC 

# ,,> 121ppm) or aquatic nonvascularplants (Selenastrumcapricomutum EC,, averages70 ppm) although EFED is still requesting aquatic nonvascularplant 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 clothianidinis allowed to be sprayed on blooming, pollen-shedding, or nectar producingparts of plants. Avian acute and chronicRQs 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 110slightly exceeded the endangered speciesLOC 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 clothianidintreated seed. It would seem unlikely birds or mammals would or could ingest the amount of seedneeded 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 15g mammals and freshwater invertebrates were exceededthus risk is possible should exposure actbally occur. However, the estimated chance of individual mortality following clothianidin exposure is 

### 1in 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 stableunder aerobic soil metabolism conditions (half-livesrange from 148to 6,900 days), and shows moderate stabilityunder anaerobic aquatic metabolism (half-lifeof 27 days for the overall system). Laboratory data suggests that photolysis appearsto play a role in the dissipation of the chemical (half-lifeof 14.4 hours in sterile water, 25.4 hours in natural water, and 34 days on soil). Clothianidinhas 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) indicatesthat 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 contaminationof soil and water with these products might occur. The terrestrial field dissipation studies confirmthe findings in the laboratory studies. Clothianidin was found to be persistent in the field (half-livesof 277 days, 1,400days, and too high to calculate). Based on the overall picture that the laboratory and field studiesprovided, EFED concluded that there is a very high likelihood that clothianidinwould 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 indicatethat clothianihn is initially labile and then relatively persistent under most environmental conditions. This makes the chemical available for lengthyperiods of time for runoff and exposure to aquatic environments. The impact of clothianidinto aquatic environmentswill also be affected by its mobility. The available studies indicated that clothianidinis 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 (freshwaterand estuarinelrnarine fish and invertebrates)can be exposed to clothianidinby runoff or spray drift into surfacewater. However,EFED's risk assessment suggeststhat toxic risk to freshwater and estuarinelmarinefish 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 110possibility of acute toxic risk 

### (RQ 

### = 0.086) to freshwaterbenthic invertebrates, via runoff especiallyif repeated uses occur. Because the clothianidin toxicity threshold is low for freshwaterbenthic invertebrates on an acute basis, their vulnerability represents acute potential risk from accumulationsof clothiandinin sediments. As a dynamic trophic level, invertebrates add to the diversityof 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 assemblagesof benthic communitiesin order to determinepotential impacts to aquatic systems.
EFED's risk characterizationof 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 terrestrialbirds and mammals is unlikely.Mammalian chronic RQs also did not exceed LOCs forboth endangered and non-endangered species.No species were at risk from ingestion of clothianidintreated seed. It would seem unlikely small birds or mammals would or could ingest the amount of granulesneeded 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 compoundedby 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 showsthat 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 suggeststhat chronic toxicity in mammals can be manifested as systemic effects that can include decreasedbody weight gains and delayed sexual maturation (males only); decreased absolute thymus weight in F1pups (both sexes), and increased stillbirths (F1 andF2 litters). Reproductive effects were also noted for adult rats that included decreased sperm motility and ihcreasednumber of sperm with detached heads. Although these effects did not reducerat fecunklity, they doraise an uncertainty as to possible reproductive effects to other speciesthat may have a more limited (less frequent) reproductivecapability. Because smallmammals may feed on fruit and thus, be subject to repeated or continuous exposure to the pesticide, additional modeling shouldbe done to determineif mammals are at risk from repeated uses of clothianidin.
Accumulation of clothianidinin soils as the result of multiple applications and repeated or continuous exposure may adverselyaffect soil invertebrates. Subchronic invertebrate toxicity studies showed that clothianidin adversely affected earthworm mortality and body weight (LC,, = 15.5ppm) and its degradates reducedbody weight (LC,, = 982.6 ppm). Additional testing (chronic study) or modeling is needed to determineif soil invertebrates are at risk from repeated uses of clothianidin. Because small mammals may burrow in the soils, additionalmodeling shouldbe done to determineif mammals are at risk from repeated uses of clothianidin. Although 

### EFED does not conduct a risk quotientbased risk assessmenton 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 110to honey bees and other beneficial insects. Other neonicotinoid compounds like imidacloprid (e.g., sunflower seed treatment) have resulted in incidentsto honey bees. The National Union of French Beekeepershad concernsregarding imidacolprid (GAUCHO) seed treatment to sunflowers after beekeepers noted that honey bees were showing modifications of behaviorthat were reflected in foraging and orientationthat 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 andlorpollen. Further studiesmay be needed to determine toxicity to honeybees from granular, seed treatment or foliar spray applications.
The uncertainties associatedwith clothianidin exposure in the environment are mainly focusedin four areas; 1) accumulationof clothianidin in soils after repeated uses and the potential for transportfmiprationto 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 accumulationof foliar spray on plants/blooms from repeated uses in orchards, and 4) repeated or continuous exposureto 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 Beekeepershad concernsregarding imidacloprid (GAUCHO) seed treatment to sunflowers. Beekeepers noted that bees were showing modifications of behavior that was reflected in foraging and orientationthat eventually resulted in a drastic change in hive conditions and bee survival. Furtherresearch by the CETIOM confirmed imidacloprid toxic residue levels in the sunflower nectar. France has banhed the use of imidaclopridfor sunflower seed treatment. This may be a concern since AE 1283742 seed treatment contains not only clothianidin,but also imidacloprid 

### Endocrine Disruption Data suggeststhat clothianidin could be a candidate for additional screening andlortesting to better characterize effects related to endocrine disruption. Effects in avian species included significant decreasesin eggshell thickness. Effects in mammalian reproduction studies included decreasedbody 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 110FQPA, to develop a screeningprogram to determinewhether certain substances (includingall 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 recommendationsof its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determinedthat 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 recommendationthat the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA

I and, to the extent that effects in wildlifemay help determine whether a substancemay have an effect in humans, m;DCA authorityto require the wildlife evaluations. As the science develops and resources allow, screening of additionalhormone systemsmay be added to the Endocrine
I Dismptor Screening Program (EDSP).When the appropriate screening and or testingprotocols being consideredunder the Agency's Endocrine Disruptor Screening Program have been

I developed, clothianidinmay be subjectedto 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, clothianidinmay pose slight acute 

### (RQ 

### =0.12) risk of adverse effects, should exposure actuallyoccur. Endangered small (15g) mammal speciesmay 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 smallbirds or mammals would or could ingest the amount of granulesneeded 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 speciesLOCs. Some of these listed speciesmay not be at risk through exposure to clothianidin based on size, food items and habitat. The entire list of listed endangeredlthreatenedspeciesis given in Appendix VI.

Page 30 of 110Page 31 of 110



## -- --Page 32 of 110Page 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 speciesto the use sites. This requirementmay be satisfiedin one of three ways: 1) having membership in the FIFRA Endangered Species Task Force (Pesticide RegistrationNotice 2000-2); 

### 2) citing FIFRA Endangered Species Task Force data; or 

### 3) independentlyproducing 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 recommendationsto 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 conservativelyassumes that listed species are co-locatedwith the pesticide treatment area. This means that terrestrialplants 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 ofhigh 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 formay 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 considerhow this information would impact the action area for a particular listed organism and may include exposures that are downwind and downstreamof the pesticide use site. 

### Indirect Effects Analysis The Agency acknowledges that pesticides have the potential to exert indirect effects upon the listed organismsby, for example, perturbing forage or prey availability, alteringthe extent of 2 1 6 4 5 1 4 59

Page 34 of 110 2

16 10 1 18

5 2

62 1

2

39 1

1

29nesting 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 concerningthe 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 estimatethe probability of acute effects associatedwith an exposure equivalentto 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 adverselyaffect" determination can be made. The degreeto which additional analyses are performed is commensurate with the predicted probability of adverse effects from the comparison of the dose response informationwith the EECs. The greater the probability that exposures will produce effects on a taxa, the greaterthe concern for potential indirect effects for listed species dependentupon 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 regardingthe 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 applicationsonly 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 effectsto 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 determineif listed organismsfor which plants are a critical componentof 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 organismsthat are either plant species obligates or plant dependent reside within the pesticideuse area, a no effect determinationon listed speciesis made. 

### If plant species obligate or dependent organismmay reside within the pesticide use area, the Agency may consider temporal and geographical nature of exposure, and the scope of the effects data, to determineif any potential effects can be determinedto not likely adverselyaffect a plant species obligate or dependent listed organism.
Indirect effects to terrestrial animalsmay result from reduced food items to animals,behavior modifications from reduced or a modified habitat, and from alterationsof habitats. Alterationsof habitats can affect the reproductive capacity of some terrestrial animals. 

### Probit SlopeAnalysis The probit slope response relationshipis evaluated to calculate the chance of an individual event correspondingto the listed species acute LOCs. If informationis unavailable to estimate a slope
Page 

### 35 of 110for 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 frommammalian terrestrial acute toxicity studies for clothianidinprovided an estimate ofislope (7.61) for females only (LD50 = 389M/465Fmglkg). Based on this slope, the corresponding estimate chance ofinlvidual 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 estuarinelmarineinvertebrates. Based on these slopes, the corresponding estimate chance of individual mortality following clothianidin exposure is only 1in 5.76 x 107,for freshwater invertebrates and 1in 2.1 x 

### lo9for estuarinelmarineinvertebrates. 

### 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 identifiedby the U.S Fish and Wildlife and National Marine Fisheries Services as essential to the conservationof a listed species and which may require specialmanagement 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 assessmenthas 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 elementsthat fall into, the taxa that may be directly or inlrectly impactedby the pesticide. Then EPA would determinewhether use of the pesticide overlaps the critical habitat or the occupiedrange 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 directlyby 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 110features 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 intproblemformulation for further assessmentof 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 (especiallyin the presence of pollinators or nesting birds), and increasing the interval between applicationsmay be implemented for clothianidin as possible risk reduction measures. In order to fully evaluate the possibility of chronic exposureto 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 shouldbe done to simulatethe potential affects of repeated uses in orderto determineif reproduction and development are affected in birds and mammals by chronic exposure. Additional modeling or toxicity testing shouldbe done to determineif 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 uncertaintyof possible risk to invertebratesthat inhabit or come into contact with sediment receiving surface waterrunoff 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 clothianidinpersists in the environment representing a continual source as an environlmental sink. This is a 28 day test that measures survival, growth and emergence of Chironomusriparius that have been exposed to pesticide spiked sedment.
Since clothianidinmay serve as an environmental sink in aquatic sediments, additional informationis needed to addresspotential effects of repeated uses. Aquatic field studies should be performed to determine system-wide effects to the assemblagesof organismsin 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 sterilepH 5,7and 9 buffer solutions at 25°C; 294% of the applied was undegraded at 33 days (study termination; MRID 45422317). Clothianidindid 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 significantdegradates 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 concentrationsof 59.2% and 22:6% of applied, respectively, at 1.9days posttreatment.

161-2 Photolysis in Water (MRIDs: 45422318,45422319,45422320,45422321,45422322) Nitroimino- and thiazolyl- [14C]clothianidin photodegraded rapidly in sterilepH 

### 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 14.4hours (extrapolating from the actual study conditions assuming mid-summer sunny conditions in Phoenix, Arizona; based on continuous irradiation; 5.76hours of irradiationwere equivalentto 1day 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-livesof 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 8.7hours (range 0.7 to 14.4hours). Clothianidn was ~5% of the applied at and after 4 days posttreatment. No significant degradation occurred in the dark controls. This study suggests a longertransformation period than the sterilebuffer 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 concentrationsof 46.5% (696hours), 28.0% (120 hours), and 12.0% (432 hours) of the applied, respectively. 

### [~hiazolyl-14C]clothianidin degraded mainly to CO,, with a maximum concentrationsof 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% (432hours) of the
Page 38 of 110applied, respectively. 161-3 Photodegradation on Soil 

### (MRID: 45422323) Clothianidindegraded with a half-life of 8.2 days in a sandy loam soil at 20°C, based on continuous irradiation; 5.76hours of irradiation were equivalent to 1 day of clear midday midsummer sunlight at 40°N latitude 

### (MRID45422323). The equivalent environmental half-life calculated assuming 5.76hours under study conditions equals one day under natural summer sunlight is 34 days. At study termination (17 days), 22.3% of the clothianidinremained undegraded. No significant degradation occurred in the dark controls. No degradates accumulated to significantlevels during the study.
161-4 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 soilsranging in texture from sand to silt loam with half-lives of 495 to 1,155days, and in a tenth soil (loamy sand, 0.35% OC) with a half-life of 6,932 days (MRDs45422325 and 45422326). 

### In all cases, the data were extrapolatedbeyond 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 113bar 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 temperatureof 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 (BBA2.2) from Germany (MRID45422325) 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 120days

68.6% at 120days

57.8% at 365 days

80.8% at 181 days Extrapolatedhalflife, days 148

239

495

533Residue 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 nitroiminomoiety, 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 10.01M CaCl2 6.2215.31

6.7416.01

6.6615.91

6.716.7

6.6715.84

6.6715.84

Page 40 of 110 % Remainingat end of study 79.5% at 181days

60.3% at 379 days

78.3%at 181days

75.8%at 365 days

87.5% at 181days

95.3% at 181days Extrapolated halflife, days 533

578

693

990

1155

6932rapid 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 (MRIDs45422325 and 45422326).
162-2Anaerobic SoilMetabolism 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 14days 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 120days and was ~2.0% in the sediment at and after 183days. 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: 45422311 and 45422312) Clothianidin has medium to very high mobility in soilsranging from sand to clay loam, with Freundlich adsorption coefficients ranging between 0.52 and 4.14 (MRID45422311). Soil organic carbon partition coefficients (kc) values were 84 to 129for 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 inthe 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 170I In addition, the desorption of aged clothianidin was studedusing 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 1.35mg a.i./kg, and incubated at 20 2 1°Cfor 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.

Similarresults 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 153to 323 and 98 to 3 11. The study author attributed the increasing Koc values to changes in the sorption process, leadingto 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, 45422315, 454223 16) The mobility of four clothianidjn degradates (MNG, TZMU, TZNG, and TMG) was also studied in three US and two German soilsusing 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 110 Kd 1.67 1.99

4.58 Kd 1.48 1.77

4.14

Days ofAging 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 582carbon partition coefficients ranging from 5.2 to 34.3 (MRID 45422313). TZMU had high to very high mobility, with Freundlich adsorption coefficients rangingbetween 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 degradatesMNG, 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 calculateddue 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 346.2 270.8 276.2 280.6Soil 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 studieswas 243 or 660 g a.i/ha, approximately two and six times the maximum proposed label rate (corn; 1.5mglseed, equivalent to 122g 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 1,386days (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 forthe Saskatchewan test site. No degradates were detected at >lo% of the applied, with the exceptionof 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 110Reviewer-calculated, based on residues in the 0-15 cm soil layer. Registrant-calculated,based on residues in all soil layers. Excludes outlier at 842 daysposttreatment (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 (0.122mgkg) and 678 days (0.0916 mglkg), respective1 y. 

## 'A half-life could not be determined at the Saskatchewan test site due to limited dissipation duringthe study. Dissipation of clothianidinin five field studies following a single application of 

### TI-435 FS 600 to bare soil.

Page 

### 45 of 110 ,



## 'Concentrationin the 0-15 cm soil layer. Geographic location Wisconsin,USA 

# - Ohio, USA

North Dakota, USA Ontario, Canada
Saskatchewan, Canada5 Soil texture (0-15cm) 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.' 0.319mglkg (7 days)

0.235 mgkg (7 days)

0.124mgkg (15 days)4

0.278mgkg (7 days)

0.08 11-0.0985mgkg (day

# w6 Conc. at study termination1 0.030 mgkg (823 days) 0.0305 mgkg (735 days) 0.0353mglkg (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
1,330days

980 days
2,780 days
1,160days

Could not be determined7TI-435 5OWDG Terrestrial field dissipation. Terrestrial field dissipation studies of clothianidln (TI-435 5OWDG) applied to bare soil have been submittedfrom California (MRID 45490703), Washington (MRID 45490704) and Georgia 

### (MRID 45490705). Clothianidin was applied as a broadcast sprayusing 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 degradateswere detected at >lo% of the applied.

Page 46 of 1 10

### ~fTI-435 50 

### WDG to bare soil. IlGeographic 

## I Soil-texture (~""lication 

## I Tn~nrnnraterl 

### I1 

# I Not calculable 

# 1 Dissipation of clothianidin in three field studies following

### a single application ( 1 I 

## -
-----A r--..w.. rime to maximum 

### 1 (0-15cm) 

### ( 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
Concentrationin 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 variabilityof 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) 9904days 686 days

30704 daysIn lysimeter studies conducted in the Federal Republic of Germany (FRG), clothianidinwas 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/applicationto an enclosed plot (1m2x 1.3m 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 100g a.i./ha and 138 g a.i./ha,respectively,to an enclosed plot (1m2x 1.3m 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 detectedin the leachate;the loss of radioactivity, approximately54-56%,was attributedto 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 accountingfor the majority of the extracted radioactivity (maximum of 18.02pglkg soil in the 0-10 cm soil layer). The degradates MNG, TZNG and NTG were detected at maximum concentrationsof 1.57pglkg 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 appliedwas detectedin the soil, 3% was detected in the harvested crops and 0.3% was detected in the leachate; the loss of radioactivity, approximately37%, was attributed to mineralizationof 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 concentrationof 5.21 pglkg soil in the 10cm soil layer. Clothianidin and TZNG were detected in the harvested crops, with the majority of the radioactivitybeing detected in the hulls/straw and chaff. Four unknown degradates were detected in the leachate samples; clothianidinwas not detected in any leachate samples. Ancillary studies - The extraction efficiencyof two analytical methods to determine clothianidin and its degradatesTZNG, MNG, TZMU and TNG was compared in two aged German soils (MRID 45422604). Radiolabeled test substanceswere 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 1/3bar moisture under static aerobic conditions for 92 days. For the "lab method", 100g soil samples were extracted four times with acetonitrile and once with water by shaking; following centrifugation, extracts were filtered and analyzedby 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:aceticacid:guanidine hydrochloride (200:800:0.8:8, v:v:v:w) at a temperature of 140°Cand a pressure of 140 bar; extracts were analyzedby TLC.
Page 48 of 110Both 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/mineralizationcapacity of the 100g 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 degradatesTZNG, 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 12months at temperaturesbetween -18 and -25°C (MRID 45422612). Following storage, clothianidin and the degradates were extracted from soil with acetonitri1e:water:aceticacid:guanidinehydrochloride (200:800:0.8:8, v:v:v:w) using an Accelerated SolventExtractor (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-MNGand d3- TMG) were used to compensate for possiblematrix effects in the MSIMS detector. Mean recoveries of TI-435 were 106% at day 0,98.4% at 118 days, 96.1% at 180days, and 91.2% following356 days of storage. Mean recoveries of TZNG were 94.6% at day 0, 101% at 118days, 98.6% at 180days, and 92.4% following 356 days of storage. Mean recoveries of TZMU were 104% at day 0 and 118days, 95.6% at 180days, and 93.7% following 356 days of storage. Mean recoveries of TMG were 95.6% at day 0, 82.3% at 118days, 94.4% at 180days, and 83.4% following 356 days of storage. Mean recoveries of MNG were 95.7% at day 0,96.1% at 118days, 110% at 180days, and 101%following356 days of storage. The study "is still running for at least one more year."
164-2Aquatic 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 58.2I 165-4 Bioaccumulation in Fish (waived) This data requirement has been waived. Octanol/waterpartitioning (Kow) data provided in an aerobic aquatic metabolism study indicates a low potential for clothianidin to accumulate (Kow for clothianidin = 1.12at pH 7; MRID 45422329).
165-5 Accumulation 

### -Aquatic Non-target Organisms Reserved.
166-1 Groundwater - Small Prospective The study was requested and isrequired.
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 50WDG) was studiedby 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 150and 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, straightback 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 150psi (treatments 1-16) or 100psi (treatments 17-24). For application methods at a liquid pressure of 150psi (airstream velocities of 74 and 136mph, rate 150and 300 gallons/acre), the mean D,,, ranged from 161-274pm. At a liquid pressure of 100psi, 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 (150psi) 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 110Reserved.



### Appendix 

### 11. Ecological Toxicity Data Summaries Toxicity to Terrestrial Animals

Page 

### 51 of 110Birds, 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 >2,000mgkg 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 1,000and 2,000 mgkgtest groups. A study conducted on a nonguideline species, Japanese quail, showed that the 14-day oral

### LD,, is 423 mg/kg. The NOAEL is 12,5mg/kg bw based on clinical signs of toxicity (lethargy and ruffled appearanced)at the 25 mg/kg treatment level. Based on these results, clothianidinis categorized as ranging from practicallynon-toxic to moderately toxic to avian specieson 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 Practicallynon- 45422417 Core (Colinusvirginianus) toxic Johnson, 1998 Japanese Quail 97.6 423 Moderatelytoxic 454224 18 Supplemental (Coturnixcoturnix Gallagheret japonica) 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 >5,000ppm; therefore, clothianidin is categorized as practicallynon-toxic to avian specieson a subacute dietary basis. The 8-day NOAEC's for each speciesbased 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 SubacuteDietary Studies

Species 9% ai 5-DayLC50 Toxicity MRJD No. Study (PP~)' Category Author, Year Classification Northern 96 >5,230 Practicallynon- 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 requiredfor 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 110data show that clothianidin exposure of 525 ppm adversely affected eggshell thickness for bobwhite quail, but did not result in chronic effects during reproductionfor 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 Gallagheret al.., 2000 Mammals, Acute and Chronic Wild mammal testing is required on a case-by-case basis, dependingon 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 (Rattus 

# I Rat

Page 

### 53 of 110 % a.i.
Mortality 

# I45422621 Gardner, 1997

# I

Rabbit (Sylvilagus SP.) Test Type

Decreased body weight gains and delayed sexual maturation (males only); decreased absolutethymus weight in F1 pups (both sexes), and increased stillbirths (F1and 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, 1998Decreased 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: 1mg/kg/day = 20 pprn in adult rats, 10pprn in younger rats, 7 pprn in mice and 33pprn in rabbits. (Nelson, 1975) pprn value determined from study. The results indicate that clothianidin is categorized as practically non-toxic to smallmammals on an acute oral basis (LD,, = 389->5,000mg/kg/day).
In the 2-generation rat reproduction study, offspring systemic toxicity was detected for males and females at 500pprn 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 forreproduction was 500ppm. 

### 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 honeybee acute contact studyusing the TGAI is required for clothianidinbecause its foliar application treatment use will result in honey bee exposure. The acute contactLD,,, 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 contactLD,, for clothianidin is 0.0439 pg a.i./beeand 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 availablefor clothianidin and its metabolites; however,they are categorized as supplemental because the submissionof honey bee acute oral toxicity studies is not a guideline requirement. The Office of Pesticide Programs (OPP) does not have a categorization schemefor acute oral toxicity to honey bees. However,based on the ICBB (1985) acute oral toxicity categorization scheme, clothianidinwould 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 Classification % ai

96

96 LD50 (pgailbee)

0.0439 Toxicity Category

highly toxic

0.0037 45422426 Weyman, 1998 not applicable 45422426 Weyman, 1998

Supplemental CoreInsects, 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 carabidbeetles (Poeciluscupreus) under extended laboratorytest conditions. The goal of these studies was to evaluate whether or not exposing carabidbeetles 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 causedbehavioral 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 designedto 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 observedbetween the control and clothianidin Wilkins, 2000

treatment groups for adult mortality. Reproductive performance (as indicatedby decreased number of progeny) was affected in the two highest clothianidin treatment groups (200 and 250 pg a.i./kg soil). The goal ,offinal two (2) rove beetle studies was to evaluate whether or not exposure of rove beetles to corn seeds (MRID No. 45422522) treated at arate 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./kgTI 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 Hoheybee (Abismellifera) 48Ihour >I13 not applicable 45422429 Wilkins, 2000

98.6 Supplemental

3.95 not applicable 45422430 Wilkins, 2000 Supplementalwhen comparedto the controls. The reproductiveperformance 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 increasein 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 scientificallysound 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 applicationwhen the proposed use pattern indicatesthat 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 studyis to develop data on the residual toxicity to honey bees. Bee mortality determinations are made from bees exposedto treated foliage harvested at various time periods after treatment. Clothianidin, as indicated in the acute toxicity test (MRID45422426),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 accordancewith Guideline 141-2 - Honey Bee Toxicity of Residues on Foliage. A scientificallysound study was performed. Alfalfa foliage was sprayedwith 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 observationswere 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 requiredto reduce the activity of the test material and bring bee mortality down to 25% in cage test exposures to field-weatheredspray deposits (Mayer and Johansen, 1990). The time period determinedby this toxicity value is consideredto be time that the test material is expectedto remain toxic to bees in the field from the residual exposureof 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 seedstreated at various applicationrates (8.62 lb ail1000 lb seed or 0.038 lb ailacre; 10.4lb ail1000 lb seed or 0.046 lb ailacre; 

### 6 lb ail1000 lb seed Page 56 of 110or 0.04 lb ailacre; and 1lb 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 requirementsfor 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 conductedin the United States, longer duration of honey bee activity observations, and the use of replicationsin the treatments and controls for statistical analyses. Field exposureto the test substance and the bee observationperiod 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 approximately63 days.
These field studies evaluated the effects to smallhoney bee colonies hived on clothianidin rape seed treated and untreated (control) plots. Colonies were placed on the treated and untreatedplots during the rape bloom stage approximatelytwo months after the rape crops were planted. Bees were monitored for shortperiods of time to determineif they were being adversely affected by the clothianidin exposure as a result of the systemic activity demonstratedby clothianidin. Residues of clothianidin in the nectar from rape flowersranged from 1.0 to 7.2pg aikg. Nectar sampled from beehives ranged from 0.9 to 3.7pg aikg and nectar sampled from foragebees honey stomachs contained 8.6pg aikg clothianidin. Residues of clothianidinwere also found in forage bees (1.4 pg ailkg),rape flowers (3.3 - 4.1 pg ailkg), pollen taken from foragingbees (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 treatmentsperformed approximately60 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 metaboliteswere 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 effectsto the foraging activity of the bees. However, the residue levels in the nectar taken from the bees, 8.6 pg ailkg, exceedsthe 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 affectedby residues of clothianidin; however, residues were not quantifiedin 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 ail1000lb 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 foragebees 

# 1 1.4 

# I

nectar from 1.2 and

Page 57 of 110 rape flowers 4.1

### Page 58 of 110Non-targetInsect Field Studies



### * <Level of Quantification (LOQ) =1.0 pgkg and Level of Detection (LOD) = 0.3 pg/kg
A seventhhoney bee field study (MRID No. 45422440),reviewed under guideline 141-5, evaluated the effects of clothianidin treated pollen on the developmentof small honey bee colonies and on the behavior and mortalityof 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 19.7pg ailkgproduced no significant adverse effects to the parameters measured in this studybased upon the visual inspection of the data. The parameters measured included mortality, foraging activity (includinghoney and pollen collection), comb production, honey storage behavior, population growth (includingegg, 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 comparedto 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 seedsper 1170 cm2test 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' resultsindicated that the wolf spider mortality and feeding capacity in the clothianidin treatments were not significantly differentfrom the controls. These studies were scientifically sound and classified as Supplemental.

- Earthworm, Acute and Chronic Five acutelchronic earthworm studieswere reviewed for clothianidin and its metaboliteltransformation products. These studies were conducted in compliancewith the Organization for Economic Cooperation and Development (OECD) guidelinesfor 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 earthwormLC,, (conc. in soil) was determined to be 15.5mglkg (MRID No. 454225 11)with the metabolite,

### MNG, and transformation product, TZNG, being less toxic to earthwormsthan the parent compound. EPA does not presently require reproductive or population toxicity testing with earthworms for pesticide registration; however, two studies indicate that clothianidin exhibitsno 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 110EarthwormAcute a1 

# I
SpecieslStudy Duration

Eisenia fetida
14days ClothianidinTransfo~ Eisenia fetida
14days d Chronic Toxicit LC501 NOAECI

+ 

# I(mglkgin dry (mg/kgin 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
reductionin body weight MRID# AuthorNear Study Classification

454225 12 Noack, 2000

1Equivalent to >500,000 clothianidin dressed corn seedsha Acceptable

45422513 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 requiredto establish the acute toxicity of clothianidinto fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish (a warmwater fish). The acute studiesthat were submittedthat tested the parent compound showed that clothianidinispractically non-toxic to freshwater fish (LC,, >105.8 -117 ppm). Studies on degradates (TMG, MNG, and TZNG) indicated a similarpractically non-toxic profile (LC,, >I05ppm). 

### EFED will use the worst case value 

### (LC,, >105.8ppm) 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 110Freshwater 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 (Oncorhynchusmykiss) toxic Wilhelmy et al., 1998 Rainbow trout 95.1 >I10 (Oncorhynchusmykiss) TMG Rainbow trout 99.0 >lo5 (Oncorhynchusmykiss) MNG Rainbow trout 99.0 >I16 (Oncorhynchusmykiss) 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 TGAIis required for clothianidinbecause 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 fatheadminnow showed that exposure of 20 pprn has the potential to affect length and dry weight of freshwater fish. The NOAEC of 9.7pprn will be used for risk assessment purposes. The guideline (72-4) is fulfilled (MRID#45422413).

Freshwater Fish Early Life-StageToxicity 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 showedthat clothianidin is practically nontoxic to Daphnia magna with an acute 48-hour EC,, value of >I19ppm, but that it is very highly toxic to Chironomusriparius with an acute 48-hourEC,, 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-hourEC,,) 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 #45422414).
Freshwater InvertebrateAcute Toxicity for Clothianidin Page 62 of 110Species % ai 48-hour EC,, Toxicity category MRID No. Study (PP~) Authornear Cliwslfication

Waterflea 99 >I19 Practicallynon- 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 Practicallynon- 45422340 Core (Daphnia toxic Hendel, 2000 magna) Waterflea 95.1 TMG >115.2 Practicallynon- 45422339 Supplemental (Daphnia toxic Hendel, 2000 magna) 

### * TheEC,, value for exposure to Clothianidin TI-435 was the most sensitive;EC,, values for TZMU, MU, and TZNG were >I02 ppm, A3.6ppm, and 0.386 ppm, respectively. Freshwater Invertebrate, Chronic A freshwater aquatic invertebratelife-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 likelyto be continuous or recurrent and (2) aquatic acuteLC,, or EC,, values are less than 1ppm (i.e., 0.022 ppm), and (3) physicochemical properties indicate that clothianidinis 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 toxicityto daphnids and possibly other freshwater invertebrates. Exposure to 0.12ppm can result in reproductive effects, including the reduced number ofjuveniles 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 2I -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 110The 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).

EsluarinelMarineFish Acute Toxicity 96-hour Toxicity MRlD No. Study SpeciesIStatic 8 ai LC50 (PP~) Category AuthorlYear Classification (nominal) Sheepsheadminnow 97.6 >93.6 Slightlytoxic 45422411 Supplemental Scheerbaum, 1999 Estuarine and Marine Fish, Chronic No data submitted. Estuarine and Marine Invertebrates, Acute

I Acute toxicity testing with estuarinelmarine invertebratesusing 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 showedthat clothianidin significantly reduced survival of mysid shrimp at 0.05 1ppm, categorizing the compound as very highly toxic. Clothianidinwas categorized as practically non-toxic to Eastern oysterbecause adverse effects did not occur for this speciesup to concentrationsof 129.1ppm. 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).

EstuarineIMarineInvertebrateAcute Toxicity SpecieslStaticor 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 (Americamysisbahia) 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-useproduct is expectedto transport to an estuarinelrnarine environment from the intended use site, and the following conditions are met: (1) the pesticideis intended for use such that its presence in water is likelyto be continuous or recurrentregardless of toxicity, (2) an aquatic acuteLC,, orEC,, is less than 1ppm (e.g.,mysid LC,, =0.051 ppm), and (3) studies of other organisms indicate that the reproductivephysiology of fish and/or invertebratesmay 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 clothianidinreduced the number of young per reproductive day at 9.7ppb. The NOAEC of 5.1ppb will be used in Page 64 of 110assessing 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 aquaticplant 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 greaterthan or equal to 3.5 ppm reduced biomass of aquaticnon-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 64ppm will be used for evaluating acute toxic exposure to non-target aquatic plants. The guidelinerequirements (122-2 and 123-2) are fulfilled (MRID#45422503; MRID #45422504) for two of the five required species. EFED needs 3 more Core clothianidin studiesfor 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 Sutherlandet al., 2000

45422505 Dorgerloh, 2000

45422506 Dorgerloh, 2000 Study Classification Core

Core

Core

CorePage 

### 66 of 110 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 terrestrialplant 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 formulatedproducts of clothianidin (49.3% TI-435 50% WDG). The results of these studies showedthat exposure elicited no effect (that is, 2 25%) on non-target terrestrial plants, soTier 

### I1 tests were not necessary. The guidelines (122-1 a and 122-lb)

### are fulfilled 

### (MRID #45422501;

### MRID #45422502). 45422507 Dorgerloh, 2000 Cell density Green Algae (Selenastrum capricomutum) [Tier 11 Core 99.0 TZNG >103/<103Appendix 

### III. Bibliography
Page 67 of 110The following studies have been submittedto 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 studyperformed by Plant Sciences, Inc., Watsonville, CA and Ricerca,LLC, Concord, OH; sponsored and submittedby 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 submittedby 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, 1998and completionMarch 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 (fieldphase; p. 31). Final report issued July 19, 2001.
MRID 45490701 Hewitt, A.J. Orchard airblast atomization droplet size spectra for V-10066lTI435 50WDG. Unpublished studyperformed by Stewart AgriculturalResearch Services,Inc., Macon, MO; sponsoredby Valent USA Corp.,Walnut Creek CA (p. 26); and submittedby 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. Structuresof Clothianidinand 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 110TZNG (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 110

### 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 110MNG (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, estimatesof initial levels of clothianidin residues on various food items consumed by wildlife using the Fletcher nomogram followedby a first order declinemodel such as FATE. The followingtable 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 MammalianFood Item (ppm) Following a Single Applicationof Clothianidinat 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 Predictedresidual 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 representativeterrestrial bird and mammal.

Page 74 of 110

----- -- -Qlenical Name: Use Fumdation

LIpplication Rate Half-life Frequency d mication Nlaximun#ml~ear

ShatCrass Tall Grass BoadeafplawsnInsects FruiWpoMginsects
Avian 

# -

Shatccass
Tall Crass
Boadeafpladsnlnseds FruiWpoMginsects Pwte FQ v\l.ichdsesFKXexceed alron'c R3 Ah Acute Auanalraic , Mian Pane Mim Chronic finfirst 56)

Pwte FQ AcuteR3 Pale ~n --- - (dt.aA3s) (dt.aFps) ShcrtGrass (dl. aFps) a12 am Tall Grass a02 a05 aa am Boadeafplawsninsects a07 a05 am FruiWpoMginaeds Q01 am am am am am Figure Appendix V-2: Clothianidin's Use onApples ELL-Fate Version 1.4

I

Page 75 of 110

### Appendix 

### VI: List 

### of Listed EndangeredlThreatened Species 

## Species Detail by 

## Statefor 

## PreliminaryAssessment * Some species (gray wolf, etc...) were omitted from the listingsbecausethey are not likelyto be exposed due to to size, habitat, eating habits or other mitigating factors.

SPIDER,MADLA'S CAVE Cicurinamadla

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 Neoleptonetamyopica Arachnid CICURINA VEND (NCN) Cicurina venii Arachnid SPIDER,VESPER CAVE Cicurina vespera Arachnid PSEUDOSCORPION,TOOTH CAVE Tartarocreag~s texana Arachnid SPIDER, GOVERNMENTCANYON CAVE Neoleptoneta microps Arachnid HARVESTMAN, BEE CREEK CAVE Texellareddelli Arachnid HARVESTMAN, BONE CAVE Texella reyesl Arachnid PEARLYMUSSEL, TURGID-BLOSSOM Epioblasmaturgidula Clam PEARLYMUSSEL, PALE LILLIPUT Toxolasma cylindrellus Clam RIFFLESHELL, TAN Ep~oblasma florentinawalkeri (=E. walkeri) Clam ROCK-POCKETBOOK, OUACHITA (=WHEELER'S Arkausia wheeleri Clam PM) PEARLYMUSSEL, PINK MUCKET Lampsilis abrupta Clam

I PEARLYMUSSEL, WHlTE CATSPAW Epioblasma obliquata perobliqua Clam PEARLYMUSSEL, TUBERCLED-BLOSSOM Epioblasmatorulosatorulosa Clam PEARLYMUSSEL, WHlTE WARTYBACK Plethobasus cicatricosus Clam PEARLYMUSSEL, YELLOW-BLOSSOM Epioblasma florentina florentina Clam PEARLYMUSSEL, PURPLE CATSPAW Epioblasma obliquata obliquata Clam PIGTOE, FINE-RAYED Fusconaia cuneolus Clam POCKETBOOK, FAT Potamiluscapax 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 Fusconaiacor Clam Page 76 of 110

-.dPIGTOE, ROUGH Pleurobema plenum PIGTOE, OVAL Pleurobemapyriforme CLUBSHELL, OVATE Pleurobemaperovatum PIGTOE, FLAT (=MARSHALL'S MUSSEL) Pleurobemarnarshalli RIFFLESHELL,NORTHERN Epioblasmatomlosarangiana 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 (=PENITENTMUSSEL) COMBSHELL,UPLAND PIGTOE, HEAVY (=JUDGE TAWS MUSSEL) MUSSEL, DWARFWEDGE 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 (=GOLFSTICK PEARLY) PEARLYMUSSEL, CUMBERLANDMONKEYFACE PEARLYMUSSEL, CRACKING PEARLYMUSSEL, BIRDWING BEAN, PURPLE PEARLYMUSSEL, CUMBERLANDBEAN STIRRUPSHELL PEARLSHELL,LOUISIANA PEARLYMUSSEL, APPALACHIAN PEARLYMUSSEL, CURTIS' PEARLYMUSSEL, GREEN-BLOSSOM PEARLYMUSSEL, ALABAMA LAMP AMPHIPOD, KAUAI CAVE SHRIMP,ALABAMA CAVE Pleurobema clava Lampsilis altilis Pleurobema curtum Pleurobemacollina ' Elliptio steinstansana Pleurobema decisum Epioblasma brevidens Epioblasmapenita Eploblasmametastriata Pleurobema taitianqm Alasmidonta heterodon Epioblasma othcaloogensis Potamilusinflatus Lasmigonadecorata 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 Cyprogeniastegaria Clam Quadrula fragosa Clam Leptodea leptodon Clam Elhptoldeus sloatianus Clam Epioblasma capsaeformis Clam Ptychobranchusgreeni Clam Lampsilisperovalis Clam Medionidus simpsonianus Clam Mediouidus penicillatus Clam Pegias fabula Clam Lampsilis higginsii Clam Medionidus acutissimus Clam Alasmidonta raveneliana Alasmidonta atropurpurea Lampsilispowelli Obovaria retusa Quadrula intermedia Hemistena lata Conradillacaelata Villosa perpurpurea Villosa trabalis Quadrula stapes Margaritiferahembeli Quadrula sparsa Epioblasma florentina curtisii Epioblasmatorulosa 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 110CRAYFISH,SHASTA Pacifastacus fortis SHRIMP,CALIFORNIA FRESHWATER Syncarispacifica 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, SANDIEGO FAIRY Branchinecta sandiegonensis SHRIMP, SQUIRREL CHIMNEY CAVE Palaemonetes cummingi ISOPOD, LEE COUNTY CAVE Lirceususdagalun ISOPOD, MADISON CAVE Antrolanalira ISOPOD, SOCORRO Thermosphaeroma thermophilus AMPHIPOD, PECK'S CAVE Stygobromus(=Stygonectes)pecki sH~IMP, RIVERSIDE FAIRY Streptocephaluswoottonl SHRIMP,VERNALPOOLFAIRY Branchinectalynch1 SHRIMP,VERNALPOOLTADPOLE Lepiduruspackardi SHRIMP,LONGHORN FAIRY Branchinecta longiantenna SKIPPER,PAWNEE MONTANE Hesperia leonardusmontana GRASSHOPPER, ZAYANTE BAND-WINGED Trimerotroplsinfantilis BEETLE, OHLONETIGER Cicindelaohlone MOTH, BLACKBURN'S SPHINX Manducablackbumi MOTH, KERN PRIMROSE SPHINX Euproserpinus euterpe BEETLE, VALLEY ELDERBERRYLONGHORN Desmocerus califomicus chmorphus SKIPPER,LAGUNA MOUNTAIN Pyrgusruralis lagunae BEEPE,TOOTH CAVE GROUND Rhadine persephone BEETLE, PURITANTIGER Cicindela puritana BEETLE, NORTHEASTERN BEACH TIGER Cicindeladorsalisdorsahs BEETLE, KRETSCHMARR CAVEMOLD Texamauropsreddelli BEE~E, AMERICAN BURYING Nicrophorus americanus BEE~E, DELTA GREEN GROUND Elaphrus viridis BEETLE, COMALSPRINGS RIFnE Heterelmis comalensis BEETLE, COMALSPRINGS DRYOPID Stygopamns comalensis BEETLE, COFFIN CAVE MOLD Batrisodestexanus BEETLE, MOUNT HERMON JUNE Polyphylla barbata SKIPPER, CARSON WANDERING Pseudocopaeodes eunus obscurus FLY, DELHI SANDS FLOWER-LOVING Rhaphlomidasterminatus 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 Icariciaicarioidesfenderi BUTTERFLY, LANGE'S METALMARK Apodemia mormolangei B~RFLY, 

### K~RNER BLUE Lycaeides melissa samuehs BUTTERFLY, MlTCHELL'S SATYR Neonympha mitchellilmitchellii BUTTERFLY, MYRTLE'S SILVERSPOT Speyeria zerenemyrtleae BUlTERFLY, UNCOMPAHGRE FRITILLARY Boloria acrocnema BUTTERFLY, SMITH'S BLUE Euphilotes enoptes smithi BUTTERFLY, LOTIS BLUE Lycaeides argyrognomon lotis BEETLE, HUNGERFORD'S CRAWLING WATER Brychiushungerfordi BUTTERFLY, MISSION BLUE Icaricia icanoides missionensis RHADINE INFERNALIS(NCN) Rhadine infernalis BUTTERFLY, BAY CHECKERSPOT Euphydryasedithabayensis BU'ITERFLY, BEHREN'S SILVERSPOT Speyeria zerene behrensii Page 78 of 110 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 InsectBUTTERFLY, CALLIPPE SILVERSPOT BU?TERFLY, EL SEGUNDO BLUE BUTTERFLY, SCHAUSSWALLOWTAIL 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, CHOCTAWHATCHEEBEACH MOUSE, PACIFICPOCKET MOUSE, PERDIDO KEY BEACH MOUSE, PREBLE'SMEADOW JUMPING MOUSE, SALTMARSH HARVEST MOUSE, SOUTHEASTERN BEACH BAT, INDIANA VOLE, AMARGOSA VOLE, FLORIDA SALTMARSH 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' KANGAROORAT, 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 (=ROYALSNAIL) SHAGREEN,MAGAZINE MOUNTAIN SNAIL, ARMORED SNAIL, BLISS RAPIDS Speyeria callippe callippe Euphilotes battoides allynl Heraclidesaristodemusponceanus Callophrysmossil bayensis Neonympha mitchelliifranclsci Speyeriazerene hippolyta Euphydryaseditha quino (=E. e. wrighti) Myotis grisescens Neotoma fuscipesriparia Glaucomys sabrinus fuscus Spermophllusbrunneus brunneus Tamiasciurushudsonlcus grahamensis Sciurus niger cinereus Glaucomys sabrinus coloratus Sorex ornatusrelictus Peromyscus pohonotus ammobates Peromyscus polionotusphasma Peromyscus pohonotus allophrys Perognathuslongimembris pacificus Peromyscus polionotustrissyllepsis Zapus hudsonius preblei Reithrodontomys raviventris Peromyscus polionotusniveiventris Myotis sodalis Microtus californicus scirpensis Microtus pennsylvanicus dukecampbelli Microtus mexicanus hualpaiensls Lasiurus cinereus semotus Dipodomys nitratoides exilis Leptonycteris curasoae yerbabuenae Leptonycteris nivalis Corynorhinus(=Plecotus)townsendiiingens 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 Antrobiaculveri Campeloma decampi Athearniaanthonyi Ehmia crenatella Leptoxis taeniata Leptoxls phcata Leptoxisampla Pyrgulopsis ogmorhaphe Mesodon magazinensis Pyrgulopsis (=Marstonia)pachyta Taylorconcha serpenticola

5 Page 79of 110 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 SnailSNAIL,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 Helminthoglyptawakeriana Discus macclintocki Oxyloma haydeni kanabensis Mesodon clarkinantahala Achatinella spp. Anguispirapicta Physa narricina Tulotomamagnifica Valvata utahensis Polygyriscus virginianus Tryonia alamosae Pyrgulopsisbruneauensis 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 SeedTreatment Key files: 

### PRZM In~ut: 

### \Sorgh-Cott~Seed0506O9WE4~CottSd~O5O6O9ddprzm3.inp EXAMS EnvironmentInput: \~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 0.15291

1 0.2 125 9 8 3 99 93 92 2 0.2 125 0 120 9 8 3 94 84 83 3 0.2 125 0 12 0 9 8 3 99 83 83 0 120 *** 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 .305 .014 .014 .014 -014 .014 -014 .014 -014 .014 -014 .014 .014 .014 .014 .014 .014 Page 82 of 110 96 hr 0.15208 

### a UaY 0.14928 60 Day 0.14297 90 Uay 0.1382 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 1100 YEAR 10 YEAR YEAR 10 1 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 EFLX TCUM 0 0 1.OE5 RZFX TCUM 0 0 1.OE5


### A-VII, Part 

### 2:Modeling of ClothianidinSorghum 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 17 0.73 0.3 1 3 *** Record 6 -- ERFLAG peak
0.044403



### *** Recbrd 7 : 0.43 0.264 1 10 *** Record 8 1 *** Record 9 1 0.1 120 100 3 89 86 87 0 120 *** Record 9a-d 1 2 6 Page 86 of 110 96 hr
0.0441 14 2' 'Jay
0.043122 60 'Jay
0.041 163 90 Day
0.039691 yearly
0.03005E0101 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 110150577 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 20 120 001000000 *** Record 26 0 0 0 *** Record 30 4 188 *** 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 SummarvFile: 

### \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, 

### 3Late-Season Applicationsof C1

Page 89 of 110EECs (0.1 exceedance probability), Clothianidinon Potatoes 

### (3 late-season 

### 1 I I I I I I pplications):

Probability

0.1

PRZM - Maine Potatoes, 

### 3 Late-Season applicationsInput 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 28 Peak

1.8969

Page 90 of 1 10

-.--- 

### --- "- 96 hr

1.5305 21 Day

1.0448 60 Day

0.86999 90 Day

0.81952 Yearly

0.272060101 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 110020987 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,3Early-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 110Page 94 of 110A-VII, Part 

### 4:Modeling of Clothianidin SingleBroadcast Application on Potatoes EECs (0.1 exceedanceprobability), 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 SummarvFile: 

### \Potato-MEO50603YPRZM-EX-Clothia-ME-pota-050603.out 60Day

0.22252

Estimated Environmental (DissolvedWater) Concentrations, SingleBroadcast 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 ninni 96 hr
0.90965 Probability

0.1

Page 

### 95 of 110 Peak

1.1506ication): EECs (0.1 exceedanceprobability), Clothianidin on Potatoes (single soil apI

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.I0988 21 Day

0.54766 60 Day

0.23212 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 110300571 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 20 100 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 0.196 0.05984 1962 0.3283 0.3267 0.3204 0.3095 0.3024 0.273

Page 99 of 110

### 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 0.1071 0.1005 0.09658 0.06849 Probability

0.1

Page 100of 110 Peak 1.0701 96 hr 1.0623 21 Day 0.91612 60 Day 0.84872 90 Day 0.82327 Yearly 0.6532EProbabilit 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 *** Record6 

### -- ERFLAG '1 4 *** Record7: 0.28 0.2 1 10 1 2 354 *** Record8 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 101of 11001 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 0.1121 kglha *** Record 13 60100 *** Record 15 -- PSTNAM Clothianidin *** Record 16

160861 0 2 0.00.1 121 0.990.01 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 0.990.01 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 1608,670 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 0.990.01 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 0.990.01 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 0.990.01 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 0.990.01 160874 0 2 0.00.1 121 0.990.01 300874 0 2 0.00.1 121 0.99 0.01 160875 0 2 0.00.1 121 0.99 0.01 Page 102of 110300875 0 2 0.00.1121 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 0.00.1121 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 0.00.1121 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 0.00.1121 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 0.00.1121 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 0.00.1121 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 0.00.1121 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 0.00.1121 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" *** Record20 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 ***Record40 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 103of 110EFLX TCUM 0 0 1.OE5 RZFX TCUM 0 0 1.OE5

Clothianidin, Grapes, inputs, 1 soil application: CAgrapes "California centralvalley 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 16010102 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 310868 1 010269 150869 310869 1 010270 150870 310870 1 010271 150871 310871 1 01 0272 150872 310872 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 310879 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 010264 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 010272 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 010276 0 1 0.00.2242 0.99 0.01 010277 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 010281 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 010284 0 1 0.00.2242 0.99 0.01 old285 0 1 0.00.2242 0.99 0.01 010286 0 1 0.00.2242 0.99 0.01 010287 0 1 0.00.2242 0.99 0.01 019288 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" *** Record20 340 001002000 *** Record 26 0 0 0 *** Record 27 -- irrigation 1 0.1 0.55 0.4 *** Record 30 4 188 *** Record33 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 ***Record40 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 110EFLX 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 110

### Figure 16. PE4 Input screen for clothianidin on potatoes, 3 late-season applications totalling 0.2 Ib ailacre.

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 ailacre.



### Figure 

### 17. PE4 lnput screen for clothianidin on potatoes, 3 early-season applications totalling 0.2 Ib ailacre (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 ailacre.

Page 110of 110