## IJNTTED 

## STATESENVIRONMENTALPROTECTIONAGENCY WASHINGTON,

## D.C. 20460

Office ofChemical Safety and Pollution Prevention


### PC Code: 044309 Date:December

### 2nd, 20 10 DP 

### Barcodes: 378994,377955 

## b&ct 

## rf

### OAJ 

### :+sj+q2, 

### 46

## 15 74

SUBJECT: Revised Assessment for Clothianidin Registration of Prosper T400 Seed Treatment on Mustard Seed (Oilseed and Condiment) and PonchoNotivo Seed Treatmenton Cotton. /-: 

### FROM: Joseph Decant, Ecologist Pchael Banett, Chemist EnvironmentalRisk Branch V Environmental Fate and Effects Division (7507P)


### THROUGH: 

### Mah T. Shamim,Branch Chief EnvironmentalRisk BranchV .-CC---CC-C-- 

### EnvironmentalFate and Effects Division
TO: Kable Davis, Risk ManagerReviewer Venus Eagle, Risk Manager Insecticide-RodenticideBranch Registration Division (7505P)
This revised memo summarizesthe Environmental Fate and Effects Division's (EFED) attached revised screening-level Environmental Fhsk Assessment for clothianidin. This revised memo and risk assessment provide more informationrelated to the reclassification of a bee field study (46907801146907802)andhow it impactsthe conclusionsofthe assessment.
The registrant, Bayer Cropscience, is submitting a request for registration of clothianidin to be used as a seed treatment on cotton and mustard (oilseed and condiment). The major risk
concerns 'are with aquatic free-swimming and benthic invertebrates, terrestrial invertebrates, birds, and mammals.
The proposed use on cotton poses 

### an acute and chronic risk to freshwater and estuarinelmarine free-swimming invertebrates, but the risk in some cases depends on the incorporation method and the region ofthe U.S. where the crops are grown. The proposed use on mustard only shows
a risk concern on a chronic basis to estuarinelmarine free-swimming invertebrates with a low

### efficiency incorporation method. The proposed uses result in acute risk to freshwater and estuarinelmarine benthic invertebrates, but incorporation and region have minimal impact on the risk conclusions. Chronic risk was only present for estuarinelmarine benthic invertebrates but was independent ofincorporation efficiency and region.
Clothianidin's major risk concern is to nontarget insects (that is, honey bees). 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 a contact and an oral basis. Although 

### EFED does not conduct RQ based risk assessments on non-target insects, information from standard tests and field studies, as well as incident reports involving other neonicotinoids insecticides (e.g., imidacloprid) suggest the potential for long term toxic risk to honey bees and other beneficial insects. An incident in Germany already illustrated the toxicity of clothianidin to honeybees when allowed to drift off-site from treated seed duringplanting.

A previous field study 

### (MRID 46907801146907802) investigated the effects of clothianidin on whole hive parameters and was classified as acceptable. However, after another review of this field study in light of additional information, deficiencies were identified that render the study supplemental.

In this field study, control and treated plots were each 1hectare in size and paired, so that 

### 4 sites were established with a control plot paired with a treated plot. These plots were separated by a minimum of 250 m. The study author states, "Of 23 back-up control nectar samples, 2 

### (field ElC, July 

### 7; field W3C, July 

### 7) had detectable clothianidin residues, at a maximum of 0.922 ppb, suggesting that workers in control colonies may have foraged on clothianidin-treated canola. This may have occurred because the separation between some pairs of control and treated fields was insufficient or because the forage in some control fields was of lower quality..." 

### The inverse may also have occurred. That is, bees placed on treated fields likely foraged on the control fields, which would have reduced the level of exposure to clothianidin residues due to a lack of separation between sites. Bees have been shown to forage up to 

### 6 km (Visscher and Seeley, 1982) or even twice that in some instances when no competing forage is present (Ratnieks, 2000). The distance of 250 m is inadequate for this separation. The inadequacy is evident given contamination in some of the nectar samples taken from control hives.
Furthermore, the study authors state that, "Approximately 5 g of pollen was analyzed under a light microscope, which confirmed that bees foraged on canola, while the remainder.. 

### .". This type ofidentification simply identifies that canola was present in the pollen samples, but does not quantify the proportion of canola pollen present in the sample. 'This type of pollen evaluation does not characterize the foraging of the bees. The bees in the treated fields could have foraged disproportionately on other uncontaminated sources relative to bees in the control fields. Furthermore, the study authors simply state that to their knowledge, no other forage was present with a radius of 

### 1 

### km from the edge of the fields. However, given the ability of bees to forage long distances, this lack of data leaves uncertainty in the exposure and suggests that this study did not provide the worst case exposure scenarionecessary for use in characterizing risk.

### An addendum 

### (MRID 46907802) was submitted later that presented the results of the overwintering part of the study, which revealed that the majority of the hives, including those exposed to clothianidin during the previous season, survived the overwintering period. However, the cross-contamination in the control hives prevents a comparison between the control hives and the treated hives as they relate to whole hive parameters in this addendum. Therefore, this study can only be used to provide a qualitative description of hive survival following the exposureto clothianidinatthe levelsthat were described inthe study.

It does not satisfy the guideline 850.3040, and another field study is needed to evaluate the effects of clothianidin on bees through contaminated pollen and nectar. Exposure through contaminated pollen and nectar and potential toxic effects therefore remain an uncertainty for pollinators.



### EFED expects adverse effects to bees if clothianidin is allowed to drift from seed planting equipment. Because of this and the uncertainty surrounding the exposure and potential toxicity through contaminated pollen and nectar, 

### EFED isrecommending bee precautionary labeling. The proposed application rates and uses also pose an acute and chronic risk to small birds and mammals when clothianidin treated seeds are applied with low efficiency or no incorporation methods.
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.
Both high and low efficiency incorporation resulted in acute risk to freshwater invertebrates in North Carolina and Mississippi cotton, whereas cotton in California and mustard in North Dakota did not result in an exceedenceofthe LOC. These results suggest that certainregions of the country are more vulnerable to run-off and exposure of the proposed application rates of clothianidin, and therefore to the potential for the toxic effects of clothianidin to freshwater invertebrates. The acute lethal toxicity to benthic invertebrates also suggests this conclusion. These organisms are an integral part of the freshwater trophic system and serve as both decomposers/predators that are important for nutrient cycling and a food source for larger predators (e.g., fish). The ecological integrity in these vulnerable areas in the 

### U.S. could therefore be impacted by the use on cotton at the proposed application rate. A reduction in the cotton application rate together with maximum incorporation of the seeds into the ground could therefore limit the exposure of clothianidinto aquatic invertebrates through run-off. Specific label language that clearly states a method of incorporation and incorporation depth would make a significant impact on other risk conclusions of the proposed new uses. Risk to estuarinelmarine invertebrates on an acute basis could be effectively mitigated by this label language, as shown by the lack of LOC 

### exceedences in the high efficiency incorporation scenario (section 5.1.1). In addition, label language that would specify more efficient

### incorporation methods, such as T-banded incorporation with a specified depth, would eliminate all risk to birds and mammals by burying the seeds into the ground and thereby limiting any foraging on these seeds. 

### Outstanding Data Requirements
Environmental Fate: 162-4Aerobic Aquatic metabolism Study. Based onthe additional information submitted by the registrant, EFED agreed to change the previously-reviewed aerobic aquatic metabolism study (MRID 45422324) from "unacceptable" to "supplemental". However, the aerobic aquatic metabolism data requirements are still not fulfilled?the registrant must submit a new aerobic aquatic metabolism study. Reasons are presented below:


### 1. The potential for clothianidin to move from the treated area to the nearby surface water body has been increased significantly since 2003 because the registrant has recently added new uses on the labels. According to the review completed on 212012003 (Title 

## - "EFED Risk Assessment for the Seed Treatment of Clothianidin 600E'S on Corn and Canola", the Agency required the registrant 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 

### Ib ai/A. However, according to the new uses reviewed by EFED (Turfgrass, Tobacco, Apples, Pears, and Ornamentals), this chemical can be directly applied to the soil surface/foliage at much higher application rate (0.4 lbs ai1A). As a result,the potential for clothianidin to move from the treated
area to the nearby surface water body under the new uses is much greater than the use as a seed treatment. Therefore, there is a need for a better understanding of the fate of clothionidin in the aerobic aquatic environment.

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

### (MRID 45422324) because the test substance was labeled on the nitroimino side chain. Therefore, the fate of the thiazolyl ring remains unknown. The fate guidelines recommend to use the ring-labeled test substance.

3. A well-designed new aerobic aquatic metabolism study is deemed critical for EPA to fully
assess the risk of clothionidin in the aquatic environment.

166-1 Small-Scale Prospective 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 "EFED Risk Assessment for the Seed Treatment of Clothianidin 600FS on Corn and Canola" dated February 20, 2003 (page 3):
"Clothianidin has the properties of a chemical which could lead to widespread groundwater contamination, but no ground-water monitoring studies have been conducted to date. Should the registrant request field uses involving direct application of clothianidin

### to the land surface, Prospective Ground-Water Monitoring Studies may be needed to evaluate fully the potential impact of such uses." Due to the extreme mobility and persistence of clothianidin in the environment, a small-scale prospective groundwater monitoring study will provide additional fate information on the better understanding of this chemical in the environment and improve the certainty ofthe risk assessment. Seed Leaching Study: EFED believes that a seed leaching study would greatly increase certainty regarding a more realistic estimate of the amount of available clothianidin residues on the seed surface. This in turn would allow a refinement of exposure estimates and environmental concentration values (EECs). A study has been submitted to the Agency and is currently under review (NIRID 47483002). Ecological Effects: The database available for clothianidin to support the assessment was largely complete. The following ecological studies for clothianidin are still outstanding and need to be submitted. Honey Bee Toxicity of Residues on Foliage 

### (850.3030): This study is required for chemicals that have outdoor terrestrial uses in which honeybees will be exposed and exhibit an LD50 

### < 11 

### pg a.i./bee. The study that was submitted to satisfythis guideline is supplemental but doesnot satisfy the guideline requirement. This study is not required for this assessment due to the lack of exposure to residues on foliage from the seed treatments. This study is placed in reserve pending future new uses.
Field Test for Pollinators 

### (850.3040):The possibility of toxic exposure to nontarget pollinators through the translocation of clothianidin residues that result from seed treatments has prompted EFED to require field testing (850.3040) that can evaluate the possible chronic exposure to honey bee larvae and queen. In order to fully evaluate the possibility ofthis toxic effect, a field study should be conducted and the protocol submitted for review by the Agency prior to initiation. Another study had been submitted to satisfy this guideline requirement. While it had originally been classified as acceptable, after recent reevaluation it is classified as supplemental, and a field study is still being needed for a more refined risk assessment. Algal Toxicity 

### (850.5400):Data on four species of non-vascular plants is required. 

### A study on only one specieshas been submitted to date onSelenastrum capricornutum.



### EFEDLabel Recommendations
Label Recommendations Manufacturing Use Product Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing

### prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office ofthe 

### 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. Runoff from treated areas may be hazardous to aquatic organismsin neighboring areas. Apply this product only as specified on the label. This chemical has properties and characteristics associated with chemicals detected in ground water. The use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground water contamination. This compound is toxic to birds and mammals. Treated clothianidin seeds exposed on soil surface may be hazardous to birds and mammals. Cover or collect clothianidin seeds spilled during loading. This compound is toxic to honey bees. The persistence ofresidues and potential residual toxicity of Clothianidin in nectar and pollen suggests the possibility of chronic toxic risk to honey bee larvae and the eventual instability of the hive.

### UNITED STATESENVIRONMENTALPROTECTIONAGENCY WASHINGTON,D.C. 20460

OFFICE OFPREVENTION, PESTICIDESAND TOXIC SUBSTANCES



## Environmental Fate and Ecological Risk Assessmei~tfor .theRegistration of 

## CLOTHIANIDIN for 

## Use as 

## a SeedTreatment on 

## Mustard Seed (Oilseed and Condiment) and Cotton

ate: 12/02/10 osephDecant,Ecologist

ichael Barrett,Chemist United StatesEnvironmental Protection Agenc Officeof PesticideProgra EnvironmentalFate and Effects Div EnvironmentalRisk Bran ah T.Shamim,Chief 1200 PennsylvaniaAve., Mail Code7507

# Table of

# Contents

............................................................................................................... 1

a 

### Executive Summary 10



### ........................................................................ 1.1 Potential Risk toNon-Target Organisms 10



### .............................................................................................. 1.2 ExposureCharacterization 11



### .................................................................................................. 1.3 EffectsCharacterization 12



### ........................................................................................... 1.4 Data Gaps and Uncertainties 13



### ............................................................................................................. 2 ProblemFormulation 16 

### 2.1 Nature of Regulatory Action



### ........................................................................................... 16

...



### ..................................................................................... 2.2 Stressor Source and Distribution 16



### .............................................................................. 2.2.1 Nature ofthe Chemical Stressor 16



### ............................................................................ 2.2.2 Overview of Clothianidin Usage 17



### ......................................................................................................................... 2.3 Receptors 20



### ........................................................ 2.3.1 Aquatic and Terrestrial Receptors and Effects 20



### ................................................................................ 2.3.2 Ecosystems Potentially at Risk 21



### ..................................................................................................... 2.4 Assessment Endpoints 21



### ........................................................................................................... 2.5 Conceptual Model 21



### ....................................................................................................... 2.5.1 Risk Hypothesis 22



### ................................................................................................ 2.5.2 Conceptual Diagram 23 2.6 Analysis Plan



### ................................................................................................................... 24 2.6.1 Methods of Conducting Ecological Risk Assessment and Identification of Data



### ................................................................................................................................ Gaps -24



### ............................................................................. 2.6.2 Outstanding Data Requirements -28



### ............................................................................ 2.6.3 Measures ofEffect and Exposure 30



### ............................................................................................................ 3 Exposure Assessment 31



### ........................................................................................... 3.1 Aquatic Exposure Estimates 33



### ....................................................................................... 3.2 Terrestrial Exposure Estimates 39 4 Ecological Effects Assessment



### .............................................................................................. 40 4.1 Aquatic Effects Summary



### ...............................................................................................40 4.1.1 Freshwater and Marine Fish



### ........................................................................................ 40



### .......................................................................... 4.1.2 Freshwater and Marine Invertebrates 40 4.1.3 Aquatic Plants



### .............................................................................................................. 43



### ........................................................................................... 4

..

### 2 Terrestrial Effects Summary 43



### ................................................................... 4.2.1 Toxicity Effects on Terrestrial animals 43



### ............................................................................. 4.2.2 Toxicity Effects on Invertebrates 43



### ...................................................................... 4.2.3 Toxicity Effects on Terrestrial Plants 44 4.3 Incident Database Review



### ............................................................................................... 44

. . 

### 5 Risk 

### Characterization



### ............................................................................................................. 45



### ............................................................................................................... 5.1 

### Risk Estimation 45 5.1.1 Aquatic Risk Quotients



### ............................................................................................ 46 5.1.2 Terrestrial Risk Quotients



### ........................................................................................ 49



### .............................................................................................................. 5.2 Risk Description 49



### ...................................................................................... 5.2.1 Risk toAquatic Organisms 50



### .................................................................................. 5.2.2 Risk toTerrestrial Organisms 51 5.2.3 RiskRefinement



### ...................................................................................................... 54

### ................................................................................................................... 5.3 Uncertainties 

### 55



## ........................................................................... 5.3.1 Exposure and Effects Assessment 55 

### 6 Bibliography



## .......................................................................................................................... 55



# List of

# Tables Table 1



### . Summary of physicochemical properties of clothianidin



## ...............................................16 Table 2



## .Use information forthe proposed use of clothianidin on seeds as an insecticide



### ...........18 Table 3



## . Test species evaluated for assessing potential ecological effects of clothianidin

.......... 

### 20 

### Table4



## . Environmental fate data requirements for clothianidin



## .................................................. 24 Table 5



# . Ecological effects data requirements for clothianidin



## ................................................... 26 Table 6



## . Measures of effect and exposure for clothianidin



## .......................................................... 30 

### Table 7



## . Input parameters for PRZMIEXAMS for the calculation of aquatic and benthic EECs of



## ................................................................................................................................... clothianidin -34 Table 8

. Estimated Environmental Concentrations for Clothianidin in Surface Water



### ................ 37 Table

### 9

. Estimated Environmental Concentrations for Clothianidin in Benthic (soil-pore) Water



## .

...................................................................................................................................................... -37 Table 10



### . Estimated bound sediment concentrations for clothianidin



### .......................................... 38



### ................... Table 11



# . Top soil/ 

### sediment organic carbon fraction by PRZMEXAMS scenario 38 Table 12



## . Bound Sediment Concentrations for Clothianidin normalized to Organic Carbon



### ............................................................................................................................................ content 38 Table 13

. Summary of aquatic risk quotients for fishand aquatic invertebratesbased on surface



## .................................................................................................................................... water EECs 46 Table 14



## . Summary of aquatic acute risk quotients for benthic aquatic invertebrates based on pore water EECs



### ............................................................................................................................ 47 Table 15



## .Summary of aquatic acute risk quotients for benthic aquatic invertebrates based on sediment bound (organic carbon normalized) EECs



### ..................................................................... 47 Table 

### 16

.Summary of aquatic chronic risk quotients for benthic aquatic invertebrates based on sedimentbound (organic carbon normalized) EECs



### .....................................................................48 Table 17



### .Summary of Terrestrial Acute and Chronic Risk Quotients



### ..........................................49


# List of

# Figures Figure 1



### . Conceptual diagram depicting potential risks to terrestrial and aquatic animals from the use of clothianidin as a 

### seed-treatment insecticide



## .................................................................. 23


# List of

# Appendices Appendix A



## . REX Methodology to Calculated Nagy Doses 

### (EECs) and Risk Quotients for Birds



### ................................................................................................................................. and Mammals 57 Appendix B

. Summary ofEcotoxicity Data



### ................................................................................. 58 Appendix C



## .TheRisk Quotient Method and Levels of Concern



### .................................................. 72



### .................................. Appendix D: 

### Equilibrium Partitioning and Concentration in the Sediment 73 Appendix 

### E: Aquatic Exposure Model Input and Output



### .............................................................75

## 1. 

# Executive

# Summary The Environmental Fate and Effects Division (EFED) has completed its ecological risk assessment in support of the proposed new uses of PONCHONOTiVO on cotton seed and Prosper T400 Insecticide and Fungicide Treatment on Mustard seed (oilseed and condiment) (Clothianidin as the active ingredient). The major risk concerns are with aquatic free-swimming and benthic invertebrates, terrestrial invertebrates, birds, and mammals. 

## 1

## .I Potential Riskto Non-Target Organisms

The proposed use on cotton poses an acute and chronic risk to freshwater and estuarinelmarine free-swimming invertebrates, but the risk in some cases depends on the incorporation method and the region of the U.S. where the crops are grown. Theproposed use on mustard only shows
a risk concern on a chronic basis to estuarinelmarine free-swimming invertebrates with a low efficiency incorporation method. While EFED does not currently have an established method of assessing risk to benthic freshwater and estuarinelmarine invertebrates, there is the potential for risk when the EECs are compared with the toxicity endpoints for these taxa related to the proposed use on cotton. However, the potential risk only extends to threatened and endangered freshwater species for the mustard use.

Clothianidin's major risk concern is to nontarget insects (that is, honey bees). 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 a contact and an oral basis. Although EFED does not conduct RQ based risk assessments on non-target insects, information from standard tests and field studies, as well as incident reports involving other neonicotinoids insecticides (e.g., imidacloprid) suggest the potential for long term toxic risk to honey bees and other beneficial insects. An incident in Germany already illustrated the toxicity of clothianidin to honeybees when allowed to drift off-site from treated seed during planting.

A previous field study 

### (MRID 46907801146907802) investigated the effects of clothianidin on whole hive parameters and was classified as acceptable. However, after another review of this field study in light of additional information, deficiencies were identified that render the study supplemental. It does not satisfy the guideline 850.3040, and another field study is needed to evaluate the effects of clothianidin on bees through contaminated pollen and nectar. Exposure through contaminated pollen and nectar and potential toxic effects therefore remain an uncertainty for pollinators.

EFED 

### expects adverse effects to bees if clothianidin is allowed to drift from seed planting equipment. Because of this and the uncertainty surrounding the exposure and potential toxicity through contaminated pollen and nectar, EFED is recommending beeprecautionary labeling.

The proposed application rates and uses also pose an acute and chronic risk to small birds and mammals when clothianidin treated seeds are applied with low efficiency or no incorporation methods. 10

### 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. Both high and low efficiency incorporation resulted in acute risk to freshwater invertebrates in North Carolina and Mississippi cotton, whereas cotton in California and mustard in North Dakota, regardless of incorporation method, did not result in an exceedence of the LOC. These results suggest that certain regions of the country are more vulnerable to run-off and exposure from the proposed application rates of clothianidin, and therefore to the potential for the toxic effects of clothianidin to freshwater invertebrates. These organisms are an integral part of the freshwater trophic system and serve as both decomposers/predators that are important for nutrient cycling and a food source for larger predators, such as fish. The ecological integrity in these vulnerable areas in the 

### U.S. could therefore be impacted by the use on cotton at the proposed application rate. A reduction in the application rate together with maximum incorporation of the seeds into the ground could therefore limit the exposure of clothianidin to aquatic invertebrates through run-off. Specific label language that clearly states a method of incorporation would make a significant impact on other risk conclusions of the proposed new uses. Acute risk to free-swimming estuarinelmarine invertebrates on an acute basis could be effectively mitigated by this label language, as shown by the lack of LOC exceedences in the high efficiency incorporation scenario (section 5.1.1). 

### In addition, label language that would specify certain high efficiency incorporation methods, such as T-banded incorporation, would eliminate all risk to birds and mammalsby burying the seeds intothe ground and thereby limiting any foraging on these seeds. 

## 1.2 

## Exposure Characterization Clothianidin appears to be a persistent compound under most field conditions. Based on analysis ofthe laboratory studies alone, the major route of dissipation for clothianidin would appear to be photolysis if exposure to sunlight occurs (e.g., the measured aqueous photolysis half-life was 

### <1 day and aerobic half-lives were 148to 1155 days). Although photolysis appears to be much more rapid than other avenues of degradationldissipation of clothianidin in the laboratory studies, the very slow rate of dissipation that was observed in field studies suggests that photolysis probably is not significantunder most actual-use conditions. Photolysismay be quite importantin surface waters if residues have reached clear bodies of water and are in solution rather than bound to sediment. Clothianidin is stable to hydrolysis at environmental pHs and temperatures. Degradation is also relatively rapid under anaerobic aquatic conditions (overall half-life of 27 

### days); however, metabolic degradation occursvery slowly in aerobic soil. Clothianidinis 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 amountof leachingwas observed in the submitted field studies. Previous studies have confirmed that compounds with a similar combination of mobility and persistence characteristics have a potential to leach to ground water at some use sites. Volatilization is not expectedtobe a significant dissipation process.

## 1.3 

## Effects Characterization The acute studies that were submitted that tested the parent compound showed that clothianidin is practically non-toxic to freshwater fish (LC5o >105.8 -1 

### 17 pprn). Studies on degradates (TMG, MNG, and TZNG) indicated a similar practically non-toxic profile (LC50>I05pprn). A chronic early life stage study conducted on the fathead minnow showed that exposure of 

### 20 ppm has the potential to affect length and dry weight of freshwater fish. 

### The data submitted for estuarinelmarine fish on an acute basis showed that the LC50= 

### 93.6 ppm; therefore, clothianidin is categorized as slightly toxic. No study has been submitted on the chronic effects to estuarinelmarinefish.
Available data that was submitted that tested the parent compound showed that clothianidin is practically non-toxic to Daphnia magna with an acute 48-hour EC50value of >I19ppm, but that it is very highly toxic to Chironomus riparius with an acute 48-hour ECsovalue of 0.022 ppm. Additional data (48-hour EC50) on degradates (TZNG, MNG, and TMG) indicated a practically non-toxic to slightly toxic profile (ECSo= 

### 64.0 to >115.2 ppm). The data showed that clothianidin significantly reduced survival of mysid shrimp at 0.051 ppm, categorizing the compound as very highly toxic. Clothianidin was categorized as practically non-toxic to Eastern oyster because adverse effects did not occur for this species up to concentrations of 129.1 ppm. Regarding chronic toxicity to invertebrates, clothianidin has the potential for chronic toxicity to daphnids and possibly other freshwater invertebrates. Exposure to 0.12 pprn can result in reproductive effects, including the reduced number ofjuveniles produced per adult. The data submitted also indicate that clothianidin reduced the number of young per reproductive day at 9.7 ppb.

Two studies were submitted that assessed toxicity to sediment dwelling freshwater and estuarine/marine invertebrates. One study (MRID 46826902) assessed the toxicity to the midge (Chironomus riparius) during a 10-Day sediment exposure. This study revealed an LCsoof 11 ppb and a NOAEC of 1.1 ppb based on pore water concentrations. The other study (MRID 47199401) evaluated a 10-daywhole sediment toxicity test with Leptocheirusplumulosus using spiked sediment This study revealed an LCsoof 20.4 ppb and a NOAEC of 11.6ppb based on pore water concentrations. Therefore, clothianidin is very highly toxic to sediment dwelling aquatic invertebrates.
Studies submitted for two of the five recommended species showed that exposure to clothianidin at levels greater than or equal to 3.5 ppm reduced biomass of aquatic non-vascular plants and increased the incidence of necrotic fronds in aquatic vascular plants. Studies on degradates (TMG, MNG and TZNG) showed reductions in green algal cell density when exposed to levels 

### >1.46pprn
An extensive assessment of the potential exposure and risk to avian guideline species exposed to clothianidinby oral intubation or in the diet concluded that clothianidin was moderately toxic to bobwhite quail on 

### an acute basis (LD50> 200 mgkg) and non-toxic to the mallard duck and bobwhite quail on a sub-acutebasis (5 day LC50 >5040 pprn and 5230 pprn), respectively. The submitted chronic toxicity data show that exposure of 525 pprn of clothianidin in the diet 12

### adversely affected eggshell thickness 

### (MRID45422421).
Likewise, an assessment of potential exposure and risk to small mammals exposed to clothianidin by the oral route suggests that clothianidin is moderately toxic to small mammals on an acute oral basis (mouse LD50 

### = 389to 465 mgkglday). Reproduction studies in rats indicate that concentrations of 500 ppm clothianidin resulted in increased stillbirths and delayed sexual maturation in males. Developmental studies in rabbits indicate that concentrations of 75 mgkgldayresulted in premature deliveries, decreased gravid uterine weights, and increased litter incidenceofmissing lung lobeslfetus. Currently, EFED does not assess risk to nontarget insects or terrestrial invertebrates using the risk quotient method. However, it appears that clothianidin exposure to honeybees has the potential for high toxicity on both an acute contact and oral basis. Acute toxicity studies to honey bees show that clothianidin has the potential to be highly toxic on both a contact and an oral basis (contact LD50 =0.044 y

### g/bee; oral LD50 =0.0037 pglbee), while its degradates (e.g.,, TMG,

### MNG,

### TZMU, and 

### TZNG) aremoderately topractically non-toxic on an oral basis (LD50

= 

### 3.9 - 

### >I53 pghee). One honey bee field study (MRID 45422435) showed that mortality, pollen foraging activity, and honey yield were negatively affected by residues of clothianidin; however, residues were not quantified in this study. Another honey bee field study (MRID 45422440) showed that pollen treated with clothianidin at a measured concentration level up to 19.7 pg a.i./kg produced no significant adverse effects to mortality, foraging activity (including pollen and honey collection), comb production, honey storage behavior, population growth (including egg, larvae, pupae, and adult growth stages), and behavioral anomalies. However, only one replicate hive per treatment level was tested, therefore, statistical analysis of the data could not be performed. Subchronic invertebrate toxicity studies showed that clothianidin adversely affected earthworm mortality and body weight (LC50 

### = 15.5 ppm) and its degradates reduced body weight (LC50 = 982.6 ppm). There were no apparent effects of clothianidin on earthworm reproduction or population dynamics. For terrestrial plants, the studies that were submitted tested formulated products of clothianidin (49.3% TI-435 50% 

### WDG). The results of these studies showed that exposure elicited no effect (that is, 2 

### 25%) on non-target terrestrial plants.



## 1.4 

## Data 

## Gaps and Uncertainties Outstanding

### Data Requirements


### Environmental Fate: 162-4Aerobic Aquatic metabolism Studv. Based on the additional information submitted by the registrant, EFED agreed to change the previously-reviewed aerobic aquatic metabolism study 

### (MRID 45422324) from "unacceptable" to "supplemental". However, the aerobic aquatic metabolism data requirements are still not fulfilled, the registrant must submit a new aerobic aquatic metabolism study. Reasons arepresented below: 13

### 1. The potential for clothianidin to move from the treated area to the nearby surface water body has been increased significantly since 2003 because the registrant has recently added new uses
on the labels. According to the review completed on 212012003 (Title - 

### "EFED Risk Assessment for the Seed Treatment of Clothianidin 600FS on Corn and Canola", the Agency required the registrant 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, accordingto the new uses reviewed by 

### EFED 

### (Turfgrass,Tobacco, Apples, 

### Pears, 

### and Ornamentals), this chemical can be directly applied to the soil surfacelfoliage at much higher application rate 

### (0.4Ibs aiIA). As aresult, the potential for clothianidin to move from the treated area to the nearby surface water body under the new uses is much greater than the use as a seed treatment. Therefore, there is a need for a better understanding of the fate of clothionidin in the aerobic aquatic environment.
2. The fate of the thiazolyl ring was not monitored in the previously-reviewed aerobic aquatic metabolism study 

### (MRID 45422324) because the test substance was labeled on the nitroimino side chain. Therefore, the fate of the thiazolyl ring remains unknown. The fate guidelines recommend to use the ring-labeled test substance.


### 3. 

### A well-designed new aerobic aquatic metabolism study is deemed critical for EPA to fully assess the risk of clothionidin in the aquatic environment.

166-1 Small-Scale Prospective 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 "EFED Risk Assessment for the Seed Treatment of Clothianidin 600FS on Corn and Canola" dated February 20,2003(page 

### 3): "Clothianidin has the properties of a chemical which could lead to widespread groundwater contamination, but no ground-water monitoring studies have been conducted to date. Should the registrant request field uses involving direct application of clothianidin to the land surface, Prospective Ground-Water Monitoring Studies may be needed to evaluate fully the potential impact of such uses." Due to the extreme mobility and persistence of clothianidin in the environment, a small-scale prospective groundwater monitoring study will provide additional fate information on the better understanding of this chemical in the environment and improve the certainty ofthe risk assessment.

Seed 

### Leaching Study: EFED believes that a seed leaching study would greatly increase certainty regarding a more realistic estimate of the amount of available clothianidin residues on the seed surface. This in turn would allow a refinement of exposure estimates and environmental concentration values (EECs). A study has been submitted to the Agency and is currently under review (MRID 47483002).

### Ecological Effects: The database available for clothianidin to support the assessment was largely complete. The following ecological studies for clothianidin are still outstanding and need to be submitted. 

### Honey Bee Toxicity of Residues on Foliage (850.3030): 

### This study is required for chemicals that have outdoor terrestrial uses in which honeybees will be exposed and exhibit an 

### LD50 

### < 1

### lpga.i./bee. The study that was submitted to satisfy this guideline is supplemental but does not satisfy the guideline requirement. This study is not required for this assessment due to the lack of exposure to residues on foliage from the seed treatments. This study is placed in reserve pending futurenew uses.


### FieldTest

### for Pollinators(850.3040): 

### Thepossibility of toxic exposure to nontarget pollinators through the translocation of clothianidin residues that result from seed treatments has prompted 

### EFED to require field testing (850.3040) 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 field study should be conducted and the protocol submitted for review by the Agency prior to initiation. Another study had been submitted to satisfy this guideline requirement. While it had originally been classified as acceptable, after recent reevaluation it is classified as supplemental, and a field study is still being needed for a more refined risk assessment. 

### Algal Toxicity (850.5400): 

### Data on four species of non-vascular plants is required. A 

### study on only one species has been submitted to date on Selenastrum capricornutum.



### Uncertainties Theuncertainties associated with clothianidin exposure in the environment are mainly focused in these areas: Accumulation of clothianidin in soils after repeated uses and the potential for transport/migration to surface water bodies and potential risk to sensitive aquatic invertebrates (e.g.,sediment-dwelling benthic organisms) Label language that specifiesthe method of incorporation Potential toxic risk to pollinators (e.g. honeybees) as the result of accumulation from seed treatments andforfoliar spray onplants/blooms from repeated uses in cotton and mustard Repeated or continuous exposure to soil invertebrates and small mammals to clothianidin accumulated in soils after repeated uses. Data Gaps: The data gaps that were outlined in Section 2.6.1 were either required or conditionally required for clothianidin and still have to be submitted. Acceptable data from these studies will aid in reducing some of the uncertainty associated with this assessment. For terrestrial screening risk assessments, a generic bird or mammal is assumed to occupy either the treated field or adjacent areas receiving pesticide at a rate commensurate with the treatment rate on the field. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species exclusively and permanently occupy the treated area

### being modeled. This assumption leads to a maximum level of exposure in the risk assessment. In the absence of specific data, EFED assumes the most conservative scenario. Screening-level risk assessments for spray applications of pesticides usually consider dietary exposure alone.



# 2 

# Problem Formulation The purpose of this problem formulation is to provide the foundation for the environmental fate and ecological effects risk assessment being conducted for the seed treatment insecticides with clothianidin. Additionally, this problem formulation is intended to identify data gaps, uncertainties, and potential assumptions to address those uncertainties relative to characterizing the risk associated with the registered uses of clothianidin, which is a neonicotinoid with current
uses as a seed treatment application.



## 2.1 

## Nature of RegulatoryAction

Under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Bayer Cropsciences is seeking registration for the new uses of Clothianidin as a seed-treatment insecticide in cotton and mustard (oilseed and condiment). 

## 2.2 

## Stressor Source and Distribution

2.2.1 

## Natureof the 

## Chemical Stressor
A summary of selected physical and chemical parameters for clothianidin is presented in 

### Table 1.


### Table 1. Summary ofphysicochemical propertiesofclothianidin.

Physical-ChemicalandOther Properties

- - - - CAS Name
IUPAC Name 

### [C(E)]-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N '-nitruguanidine (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyI)-3-methyl-2-nitroguanidine

I



# I PesticideType 

# 1 Insecticide 

# I CAS 

### No Empirical Formula

Molecular Weight

Common Name 

# I Chemical Family 

# I Neonicotinoid 

# 1 210880-92-5 (previously 205510-53-8)
C6H8CIN502S

249.7
Clothianidin

### 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,theneonicotinoids (chloronicotinyl insecticides)were developed as a substitute of nicotine, targeting the same receptor site (AChR) and activating post-synaptic acetylcholine receptors but not inhibiting AChE. Clothianidin, like 

### other neonicotinoids, is an agonist of acetylcholine,the neurotransmitterthat stimulates the nAChR. In insects, neonicotinoids cause symptoms similar to that ofnicotine. The symptoms appear rapidly as increased restlessness followed by violent convulsions and death. The advantage of clothianidin and othcr neonicotinoids over nicotine is that they are less likely to break down in the environment.

Physical-Chemicaland
Color/Form
Odor Melting Point

Flash Point Relative Density Water Solubility Solubilityin other solvents

Vapor Pressure Henry's Law Constant

Kow



### 2.2.2 

### Overview 

## of Clothianidin Usage This assessment is intended to address the proposed new uses of clothianidin as a seed treatment for cotton and mustard (oilseed and condiment). The crop, target pests, and relevant application information are summarizedin 

### Table 

### 2. OtherProperties
Clear and colorless/solid,powder
odorless
176.8"C

NIA
1.61 glml (at 20°C), 1.59dcm3 0.327gL (at 20°C) heptane <O.U0104 g/L (at 25°C) xylene 0.0128 dichloromethane 1.32 methanol 6.26 octanol0.938 acetone 15.2 ethyl acetate 2.03
3.8 x10-" Pa (at 20°C)
2.9 x 10.'' Pa 

### x m3Imol 1.12 (atpH 7)

### Table 2. 

### Use informationforthe proposed useofclothianidinon seedsasan insecticide. Uses being evaluated forD377955 

### andD378994 

### arein boldeddark blue text. Summary of

### Directionsfor

### Useof

### ClothianidinSeed

### Treatments,

I I I I I 

### RootVegetables (Group 

### 1) Use Directions and Limitations
lbai/A

- - 

### Bulb Vegetables (Group3) Applic. Timing, Type, and Equip.

Seed treatmentusing commercial seed treatment equipment only

I I I 

### LeafyGreen Vegetables (Subgroup4A) Form. [EPAReg.No.] Application Rates

# '

Radish: 0.45 Carrot: 0.118 56.25%WP [264-XXX]

Seed treatmentusing commercial seed treatment equipment only



### Bramica

### LeafyVegetables 

### (Group5) g ail1000 seeds

Bulb onion: 0.18 Green onion: 0.106 Leek: 0.20 56.25%WP [264-XXX]

Seed treatment using commercial seed treatment equipment only oz ail 1000 seeds

Radish: 0.01575 Carrot: 0.0042

56.25%WP [264-XXX]

Do not use treated seed for food,feed
or oil processing. Seed treatmentusing commercial seed treatment equipment only Bulb onion: 0.006 Green onion: 0.0037 Leek: 0.0071

Head Lettuce: 0.798 LeafLettuce: 0.64 Spinach:0.16 Radish:0.50- 0.67 Carrot: 0.10- 0.25

Head Lettuce: 0.70-2.25 LeafLettuce: 0.68-2.26 Spinach: 0.09-0.21 Head Lettuce: 0.028 LeafLettuce: 0.0225 Spinach: 0.0055

56.25%WP [264-XXX]



### Fruiting

### Vegetables(Group8 j Do not use treated seed for food,feed or oil processing.

Bulb onion: 0'06-0'l9 Green onion:

0'23-0'42 Leek: 0.30- 0,35

Do not use treated seed for food, feed or oil processing. Do not use treated seed for food,feed
or oil processing,

Cabbage: 1.193 Broccoli: 1.193 Mustard Greens: 0.0995

Seed treatmentusing commercial seed treatment equipment on1y Tomato: 0.099 Pepper: 0.495 56.25%WP [264-XXX] Cabbage: 0.0416 Broccoli: 0.0416 Mustard Greens: 0.0035



# ~ Cabbage: 0.06-0.44 Broccoli: 0.39-0.42 Mustard Greens:0.03- 0.16

Tomato: 0.0035 Pepper: 0.0174 Tomato: 0'02-0.06 Pepper: 0.04-0.21



### Cereal Grains, exceptrice (Group15) Squash: 0.034 Melon: 0.034 Cucumber: 0.034 Squash: 0.04 Melon: 0.02- 0.1 1 Cucumber: 0.04-0.16 Seed treatmentusing commercial seed treatment equipment only Do not use treated seed for food,feed
or oil procesaing.

Do not use treated seed for food, feed
or oil processing. 56'25%WP [264-XXX1 Squash: 0.995 Melon: 0.995 Cucumber: 995Sununary ofDictionsfor

### Use of Clothianidin

### Seed Treatments. Applic. Timing, Type, and Equip.

Seed treatment using commercial seed treatment equipment only Form. [EPAReg. No.]

56.25% WP [264-XXX]

Wheat, Barley

### and Triticale Application Rates 

# '

Seed treatment using
on farm or commercial seed treatment equipment. g ail1000 seeds 70gail100kg seed Use Directions and Limitations

# '

7.5 g ail100 kg seed 0.128IbJgal HC [264-XXX] ozail1000 seeds 1.1250~ ail100 1bs seed ,bailA2
Corn: 0.007- 0.011 Sorghum: 0.001 -0.007 Millet: 0'01 Barley: 1-0'025

0.035-0.067 Oats: 0.034- 0.090 Wheat: 0.02 1-0.105

Potato Do not use treated seed for food, feed
or oil processing.

0.12 oz ail100 1b seed

Seed treatment using commercial seed treatment equipment on1y Barley: 0.004-0.007 Wheat: 0.002-0.01 1

56.25%WP [264-XXX] Do not use treated seed for food, feed or oil processing. Forage may be grazed or harvested 31 days after seeding.

Cotton 12.5g ail100 kg seed pieces

Seed Treatment AE 1283742 imidacloprid/ clothianidn mix 0.20oz ailloo Ibseed pieces

AE 1283742 Poncho 600

COTTON

### -NEW USE RATE

## -DP Barcode#378994 potato: 0.163-0.325

0.15 lbJ100Ibs seed Do not use treated seed for food, feed
or oil processing.

0.02

Seed Treatment 3.53 a.looO seeds 40.3%VOTiVO (unique formulation) MUSTARD SEED 

## -NEW USE RATE

## -DP Barcode#378994 Oso7' Oz aY1000seeds

Seed Treatment Up to 0.063

21.75% ProsperT400 0.215fl0~1100 Ibs seed or0.004 Ib ail 100Ibs seed Up to 0.028

## 2.3 Receptors
2.3.1 

## Aquatic and Terrestrial Receptors and Effects The receptor is a biological entity that is exposed to the stressor (US Environmental Protection Agency, 

### 1998). As described in the risk assessment Overview Document (US EPA, 2004), this risk assessment uses a surrogate species approach in its evaluation of clothianidin. Toxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate the potential effects on a variety of species (receptors) included under these taxonomic groupings. For example, the mallard duck and bobwhite quail are the preferred species in avian toxicity tests (acute and chronic) to represent toxicity for the entire class of bird species.

Acute and chronic toxicity data from studies submitted by the registrant along with the available open literature are used to evaluate potential direct effects of pesticides to aquatic and terrestrial receptors. These data include toxicity studies on the technical grade active ingredient (TGAI). The open literature are indentified through EPA's ECOTOX database (http://cfpub.epa.~ov/ecotox/), 

### which employs a literature search engine for locating chemical toxicity data for aquatic and terrestrial floral and fauna. The evaluation of both sources of data provides insight into the direct and indirect effects of pesticides on biotic communities from the loss of species that are sensitive to the clothianidin, and changes in structural and functional characteristics of the affected communities. A search of the ECOTOX database did not yield any relevant studies additional to those submitted by the registrant that would support this action.


### Table 3 provides examples of taxonomic groups and the surrogate species tested to help understand potential ecological effects of clothianidin on these non-target taxonomic groups. 

### Table 3. 

### Test species evaluatedforassessingpotential ecological effectsofclothianidin. TaxonomicGroup 

### ExIL~~~(s) ofSmgste species 

### Amte

### ToxWyCkss~tion Mallard duck (Anus ~irds' platyrlzynchos) Practically non-toxic on a dietary basis to Bobwhite quail (Colinus moderately toxic on a dose basis virginianus) Mammals Rat (Rattu~ norvegicus) Moderately toxic Bluegill sunfish (Lepomis Freshwater ~ish~ muc~rochirus) Practically non-toxic Rainbow trout (Oncorhynclzus mykiss) Freshwater Invertebrate Midge (Cllironomusriparius) Very highly toxic

Freshwater Benthic Midge (Chironornusriparius) Very highly toxic Invertebrate Estuarinelmarine fish Sheepshead minnow Slightly toxic (Cyprinodon variegates) Estuarinelmarine Mysid shrimp (Mysidopsis bahia) Very highly toxic invertebrates Estuarine Marine Benthic Leptnclzeirusplum~losus Very highly toxic Invertebrate

### Taxo11.0& Group 

### Example(s)ofSumgate Species 

### AaateToxicity

### t3am-tion Eastern oyster (Crassotrea Estuarinelmarine mollusks Practically non-toxic virginica) Terrestrial invertebrates Honey bees (Apismellifera) Highly toxic '~irds represent surrogates for terrestrial-phase amphibians and reptiles 2 Freshwater fish serve as surrogates for aquatic-phase amphibians 

### 2.3.2 

### Ecosystems Potentially at Risk The ecosystems at risk from a stressor are often exclusive in scope, and as a result it may not be possible to identify specific ecosystems at the baseline level. However, in general terms, terrestrial ecosystems potentially at risk could include the treated field and areas immediately adjacent to the treated field that may receive drift or runoff. Areas adjacent to the treated field could include other cultivated fields, fencerows, hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats, and other uncultivated areas. Aquatic ecosystems potentially at risk from a stressor include water bodies adjacent to, or down stream from the treated field and might include impounded bodies such as ponds, lakes, and reservoirs, or flowing waterways such as streams or rivers. For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries.
For clothianidin, the terrestrial ecosystem primarily at risk is the rhizosphere zone in which treated seeds areplanted on the crop field, through contaminated nectar and/or pollen, or due to the seed left (accidental spillage or otherwise) on the soil surface at the time of planting. Seedbound clothianidin may pose risk to aquatic ecosystems through leaching, runoff, or erosion from the crop field. It is noted that for soil incorporated chemicals, or seed treatments, drift is usually aminor component. 

## 2.4 

## Assessment Endpoints Assessment endpoints represent the actual environmental value that is to be protected, definedby
an ecological entity (species, community, or other entity) and its attribute or characteristics 

### (US Environmental Protection Agency 

### 1998 and 

### 2005). For clothianidin, the ecological entities include the following: birds, mammals, terrestrial plants, insects, freshwater fish and invertebrates, estuarinelmarine fish and invertebrates, aquaticplants, and algae. The assessment endpoints for each of these entities include survival, growth, and/or reproduction. This assessment will use the most sensitive toxicity measures of effect from surrogate test species to estimate treatment-related direct effects on acute mortality and chronicreproductive, growth, and survival assessment endpoints. 

## 2.5 

## Conceptual Model For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which apesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be complete, it 

### must have 

### a source, a release mechanism, an environmental .transport medium, a point of exposure for ecological receptors, and a feasibleroute of exposure. 

### 2 1

### A conceptual model is intended to provide a written description and visual representation of the predicted relationships between the stressor, potential routes of exposure, and the predicted effects for the assessment endpoint. A conceptual model consists of two major components: the risk hypothesis and the conceptual diagram (US 

### Environmental Protection Agency 1998 and 

### 2005).


### 2.5.1 

## Risk Hypothesis Risk hypotheses are specific assumptions about potential adverse effects and may be based on theory and logic, empirical data, and mathematical models. For this assessment, the risk is stressor initiated where the stressor is the release of clothianidin into the environment. Relative to the proposed use of clothianidin, EFED initially had concerns for risk to aquatic organisms due to high persistence and potential mobility of clothianidin to surface waters. In the case of this assessment, EFED relied on the clothianidin toxicity studies which considers standard single chemical toxicity testing (acute and chronic endpoints) submitted by the registrant and reviewed by the Agency. EFED used this information for selection of the most sensitive species tested in order to generate RQ values. Effects data are included under the section "Characterization of Ecological Effects," and represent registrant submitted data. The effects database is mostly complete for freshwater and estuarinelmarine aquatic organisms and thus is suitable for a screening level risk assessment. The major endpoints related to aquatic environments at issue


### are: (a). Direct effects to aquatic invertebratesin the water column via acute toxicity. (b). Direct effects to benthic aquatic organisms dwelling in the sediment andlor pore water via acute and/orchronic toxicity.

In addition to the concern for aquatic ecosystems, EFED is also concerned with potential impacts to terrestrial species and functiollal groups, including pollinators; nectar and fruit eating birds, mammals, and insects; and soil-inhabiting invertebrates and mammals (i.e. earthworms, burrowing mammals). Available effects data are included under the section "Characterization of Ecological Effects," and represent registrant submitted data. Although EFED does not conduct RQ based risk assessments on beneficial insects, there is potential for direct toxic effects to honey bees as 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 relatedto terrestrial environments at issue are: (a). Direct effects to mammals, birds, insects, and soil invertebratesvia acute toxicity. (b). Direct effects on reproduction to birds (eggshell thinning), mammals (endocrine disruption), and insects via chronic toxicity. (d). Direct effects to foraging activity of pollinators Therefore, the followingrisk hypothesis is presumed for this screening-level assessment:

### The proposed new use ofclothianidin on cotton and mustard (oilseedand condiment)will likely involve situations where terrestrial animals and aquaticplants and animals will be exposed to the chemical and or its transformation products. Based on information on environmental fate, mode 

## of action, direct toxicity, andpotential indirect eflects, EFED
assumes that clothianidin may have thepotential tocause reduced survival, growth, and reproduction to terrestrial and aquatic animals and aquatic plants as 

## a result of the proposed uses of the pesticide. However, due to the low toxicity of clothianidin to terrestrial plants and the limited exposurefrom the seed treatment, clothianidin is not likely to reduce the survival, growth, and reproduction of terrestrial plants based on the proposed uses. 

## 2.5.2 

## Conceptual Diagram The potential exposure pathways and effects of clothianidin on terrestrial and 

### aquatic environments are depicted in

### Figure 

### 1. Solid arrows represent the most likely routes of exposure and effects for clothianidin.

Stressor 

### Seed Treated with ClothianidinandPlantedin Soil or Left on 

### Soil Surface

........................................ f Leaching Source/ Runoff and Erosion t (Infiltration/ 

### i Transport f Percolation) 

### I Pathway



### ........... .......... Source/ Exposure (foliage,fruit, 

### / Media insects)/Soil Soil FoliagalSoil



### ............................ Exposure GilY Integument Method Root Uptake Uptake

................................ Terrestrial Animals Tzmcsuial Aquatic lnvertcbrates (Birds,Mammals, Upland Plants Aquatic Vertebrates Receptors Reptiles, Terrestrial- Aquatic Plants phase Amphibians, Bees)
I , r-k Individual Aauatic Direct Indi~idual Terrestrial Individual Terrestrial Verrehraresand Aauatic Plant Effects: Animals Plants Invertebrates Population Rerluced Sumii,al Seedling Emergence Reduced Sunival ReducedNonReduced Growth Vegetative Vigor Reduced Growth GrowthRates Endangered Species Reduced Reproduction Reduced Reproduction and Bionlass

Indirect Effects 

### Figure 1. 

### Conceptual diagram depicting potential risksto terrestrialand aquatic animals from the use ofclothianidin as a seed-treatment insecticide. Italicized groups oftaxa are identified asthe taxa ofconcern based on toxicity and results from previous assessments. Food Web Dynamics Perturbed Forage or Prey Availability Habitat Alteration: impacts on nesting ability, ability to scckcover, etc.

## 2.6 

## Analysis Plan

2.6.1 

## Methodsof Conducting Ecological RiskAssessment and Identificationof Data 

## Gaps This document characterizes the environmental fate and effects of clothianidin to assess whether the proposed label new use 

### of the compound results in risk to non-target organisms at levels above the Agency's LOCs. The primary method used to assess risk in this screening-level assessment is the risk quotient (RQ). The RQ is the result of comparing measures of exposureto
measures of effect. A 

### comnlonly used measure of exposure is the estimated exposure concentration (EEC) and commonlyused measures of effect include toxicity values such as 

### LDSo
or NOAEC. The resulting RQ is then compared to a specified level of concern (LOC), which represents a point of departure for concern, 1.e. if 

### the RQ exceeds the LOC, then risks are triggered. Although not necessarily a true estimate of risk since there is no estimated probability of effect, in general, the higher the RQ, the more certain the potential risks.



### Table 4 

### summarizes the environmental fate data requirements for clothianidin according to 40 

### CFR Part 

### 158 Subpart N. Studies that have been received or not yet received will be noted as such in the table.


### Table4. 

### Environmentalfate data requirementsfor clothianidin.
TableofEnvironmentalFate

### Data Requirements

Guide- Study line # Data 

### Requirement MRID # 

### Classification Is moredata needed?
161-1 Hydrolysis 161-2 Photodegradation in Water

161-3 Photodegradation on Soil 161-4 Photodegradation in Air
162-1 Aerobic Soil Metabolism

162-2 Anaerobic Soil Metabolism Core
Core Supplemental Core Supplemental Core
Core

Waived

Core Core Supplemental Supplemental

### TableofEnvironmental

### FateData

### Requirements

Guide- 

### Study line# DataRequirement MRID # Classification Ismore 

### data needed? 162-3 Anaerobic Aquatic 45422330 Core no Metabolism 162-4 Aerobic Aquatic 46826903 Core no Metabolism 45422324 Supplemental 45422329 Supplemental

163-1 Leaching- 4542231 1 Core Adsorption/Desorpti 454223 12 Ancillary
on 45422313 Supplemental 45422314 Supplemental 45422315 Supplemental 45422316 Supplemental 163-2 Laboratory Volatility NIA N/A 163-3 Field Volatility N/A N/A
164-1 Terrestrial Field 45490703 Core Dissipation 45490704 Core 45490705 Core 45422331 Supplemental 45422332 Core 45422333 Core 45422334 Core 45422335 Core 45422336 Core 45422508 Supplemental 45422604 Ancillary 454226 12 Ancillary 164-2 Aquatic Field N/A N/A Reserved Dissipation
165-4 Accumulation in NIA N/A Waived Fish

165-5 Accumulation- NIA NIA Reserved aquatic non-target

166-1 Ground Water- small N/A N/A Yes prospective 201-1 Droplet Size 45490701 Supplemental Reserved Spectrum (upgradable) Waived
Waived

noTableofEnvironmental

### FateData Requirements

Guide- Study line # Data Requirement MRID # Classification Is moredata needed?
202-1 Drift Field N/A Reserved Evaluation



### Table

### 5 summarizesthe data requirementsfor clothianidin according to 

### 40 

### CFR Part 158 Subpart 

### G. Studiesthat have been received or not yet received will be noted as such in the table.



### Table

### 5. Ecological effects data requirementsfor clothianidin.
TableofJkologicalToxicity Data Requirements

Guideline # Data Requirement 

### MRID # Classification Is more data needed?
850.2100 Avian acute oral LDso (mallard duck) Cjapanese quail)
850.2200 Avian subacute dietary LC5" (bobwhite quai)l (mallard duck)
850.2300 Avian reproduction (bobwhite quail) (mallard duck)
850.1075 Freshwater fish acuteLCSoa (rainbow trout) TGAI DEG DEG DEG Core Supplemental

Core Core

Core Supplemental

Supplemental Supplemental Supplemental Supplemental (bluegill sunfish) 45422407 Core TGAI
850.1010 Freshwater invertebrate acute ECso(daphnia) TGAI 45422338 Core DEG 45422401 Core DEG 45422340 Core DEG 45422339 Supplemental (chironomid) TGAI 45422414 Supplemental No

### TableofEcological

### Toxicity

### Data Requirements



### Guideline # Data 

### Requirement MRID # 

### Classification Is

### more dataneeded? 

# I 850.1075 Estuarinelmarinefish acute LCso(sheepshead minnow) 4542241 1 Supplemental
850.1025 Estuarinelmarine invertebrate 850.1035 acuteEC50 850.1045 (eastern oyster) 45422404 Core
850.1055 (mysid) 45422403 Core 850.1075
850.1400 Freshwater fish early life stage (fathead minnow) 45422413 Supplemental

850.1300 Freshwater invertebrate life cycle (daphnia) 45422412 Supplemental 850.1350 Estuarinelmarine life cycle (mysid) 45422405 Core
850.1735 Acute Freshwater Invertebrate SedimentToxicity TGAI 468269-02 Supplemental 850.1740 AcuteEstuarinefMarine Invertebrate Sediment Toxicity TGAI 47 1994-01 Supplemental 850.1950 Aquatic Field Study NA NA
870..1100 Acute mammalian oral 1,D~o (rat> 45422621 Core (mouse) 45422622 Core
870.4100 Mammalian Chronic (rat) 45422714- 16 Core (rat) 45422825 -26 Core (rabbit) 45422712-13 Core
850.4100 Seedling Emergence - Tier I 45422501 Core 

# 1 850.4150 VegetativeVigor 

### - Tier I 45422502 Core

850.5400 Aquatic plant algae TGAI 45422504 Core DEG 45422505 Core DEG 45422506 Core DEG 45422507 Core 850.4400 Aquaticplant acuteECS0 45422503 Core No 

### 27

### Tableof'Ecologica1Toxicity Data

### Requirements

Guideline # 

### Data Requirement MRID# 

### Classification Is moredata 

### needed?
850.3020 Acutehoney bee contactLD50 45422426 Core No

Non- Acute honey bee oral LD50 guideline TGAI 45422426 Supplemental DEG 45422427 Supplemental DEG 45422428 Supplemental DEG 45422429 Supplemental DEG 45422430 Supplemental 850.3030 Honey Bee Residue on Foliage 45490702 Supplemental $50.3040 Honey Bee Field Testing for 45422431 Supplemental Pollinators 45422432 Supplemental 45422433 Supplemental 45422435 Supplemental 45422436 Supplemental 45422437 Supplemental 45422440 Supplemental 46907801/46 907802 Yes
850.6200 Earthworm Subchronic TGAI 45422511 Core DEG 45422512 Core No DEG 45422513 Core
Non- Earthworm Chronic guideline 45422525 Supplemental No 45422526 Supplemental 'EFEDneeds 3more Tler 1orTler I1 Coreclothianidinstud~es for thenonvascular surrogate species,rnannedlatom(Skeletonerna costaturn), blue-green algae (Anabaena flos-aquae),and a freshwaterdlatorn No

Yes



### 2.6.2 

## Outstanding Data Requirements

Environmental Fate: 162-4Aerobic Aquatic metabolism Study. Based on the additional information submitted by the registrant, 

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

### (MRID 45422324) from "unacceptable" to "supplemental". However, the aerobic aquatic metabolism data requirements are still not fulfilled, the registrant must submit a new aerobic aquaticmetabolism study. Reasons are presented below:

1. The potential for clothianidin to move from the treated area to the nearby surface water body has been increased significantly since 2003 because the registrant 

### has recently added new uses
on the labels. According to the review completed on 212012003 (Title - 

### "EFED Risk 28

### Assessment for the Seed Treatment of Clothianidin 600FS on Corn and Canola", the Agency required the registrant to conduct a new aerobic aquatic metabolism study (162-4). This risk assessment was based on the maximum application rate for the seed treatment at 0.1 lb ai/A. However, according to the new uses reviewed by EFED (Turfgrass, Tobacco, Apples, Pears, and Ornamentals), this chemical can be directly applied to the soil surfacelfoliage at much higher application rate (0.4 lbs ailA). As a result, the potential forclothianidin to move from the treated area to the nearby surface water body under the new uses is much greater than the use as a seed treatment. Therefore, there is a need for a better understanding of the fate of clothionidin in the aerobic aquatic environment.
2. The fate of the thiazolyl ring was not monitored in the previously-reviewed aerobic aquatic metabolism study 

### (MRID 45422324) because the test substance was labeled on the nitroimino side chain. Therefore, the fate of the thiazolyl ring remains unknown. The fate guidelines recommend to use the ring-labeled test substance.

3. A well-designed new aerobic aquatic metabolism study is deemed critical for EPA to fully assess the risk of clothionidin in the aquatic environment. 166-1 Small-Scale Prospective 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 "EFED Risk Assessment for the Seed Treatment of Clothianidin 600FS on Corn and Canola" dated February 20,2003 (page 

### 3):

"Clothianidin has the propcrties of a chemical which could lead to widespread groundwater contamination, but no ground-water monitoring studies have been conducted to date. Should the registrant request field uses involving direct application of clothianidin to the land surface, Prospective Ground-Water Monitoring Studies may be needed to evaluate fully the potential impact of such uses." Due to the extreme mobility and persistence of clothianidin in the environment, a small-scale prospective groundwater monitoring study will provide additional fate information on the better understanding of this chemical in the environment and improvethe certainty of the risk assessment.


### Seed Leaching 

### Study: EFED believes that a seed leaching study would greatly increase certainty regarding a more realistic estimate of the amount of available clothianidin residues on the seed surface. This in turn would allow a refinement of exposure estimates and environmental concentration values (EECs). A study has been submitted and is currently under review (MRID 47483002). 

### Ecological Effects: The database available for clothianidin to support the assessment was largely complete. The following ecological studies for clothianidin are still outstanding and need to be submitted.

### Honey Bee Toxicity of Residues on Foliage (850.3030): 

### This study is required for chemicals that have outdoor terrestrial uses in which honeybees will be exposed and exhibit an LD50 

### < 11pga.i./bee. The study that was submittedto satisfy this guideline is supplemental but does not satisfy the guideline requirement. This study is not required for this assessment due to the lack of exposure to residues on foliage from the seed treatments. This study is placed in reserve pending future new uses.


### Field Test for Pollinators (850.3040): 

### The possibility of toxic exposure to non-target pollinators through the translocation of clothianidin residues that result from seed treatments has prompted 

### EFED to require field testing (850.3040) 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 field study should be conducted and the protocol submitted for review by the Agency prior to initiation. Another study had been submitted to satisfy this guideline requirement. While it had originally been classified as acceptable, after recent reevaluation it is 

### classified as supplemental, and afield study is still being needed for a more refined risk assessment. 

### Algal Toxicity (850.5400): 

### Data on four species of non-vascular plants is required. A study on only one species has been submitted to dateon Pseudokirchneriella subcapitata,formerly known
as Selenastrum capricornutum.



### 2.6.3 

## Measures

## of 

## Effectand Exposure

Table 6 

### lists the measures of environmental exposure and ecological effects used to assess the potential risks of clothianidin to non-target organisms in this assessment based on the concerns in the problem formulation. The methods used to assess the risk are consistent with those outlined in the document "Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs." (2004)


### Table 6. 

### Measuresofeffect and exposureforclothianidin. AssessmentEndgoint S~teS~ladM~ &-weal 

### PW Mwwof Expowve

- Mallard duck acute oral LD,, Survival - Bobwhite quail and mallard ~irds~ duck subacute dietary LC50 Reproduction Mallard duck and bobwhite quail Maximum residues on seed and

and growth chronic reproduction NOAEL soil

Survival Laboratory rat acute oral LDSo Mammals Reproduction Laboratory rat chronic and growth reproduction NOAEL

Survival 

# I Freshwater Water flea acute LCjo Peak EEC~ Invertebrates Reproduction Water flea NOAEC and LOAEC and growth 21-day average EEC~ 

# I Estuarinelmarine Survival Sheepshead minnow acute LC50 Peak EEC~ 

### 30

### Assessment

### Endpoint SwTogtlteSwWM

### ofEcokogical

### Effect' 

### Measuresof

### Exposure fish Reproduction and growth No study submitted 60-day average EEC~

Survival Estuarinelmarine Mysid shrimpacuteLCSo Peak EEC~

invertebrates Reproduction and growth No study submitted 21-day average

### EEC~ '1f species listed in this table represent most commonlyencountered species fromregistrant-submitted studies, 

# I risk assessment guidanceindicates most sensitive tested within taxonomic grouparetobeused forbaseline risk 

# 1 I assessments 

## I 

# I 2~irds represent surrogates for terrestrial phase amphibians and reptiles 

# I j~reshwater fish may be surrogates for amphibians (aquatic phase) 'one in 10-year frequency


# 3 

# ExposureAssessment
Summary Clothianidin appears tobe apersistent compound under 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 appearsto be much more rapid than other avenues of degradatioddissipation of 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. Photolysis may be quite important in surface waters if residues have reached clear bodies of water and are in solution rather than bound to sediment. Clothianidin is stable to hydrolysis at environmental pHs and temperatures. Degradation is also relatively rapid under anaerobic aquatic conditions (overall half-life of 27 

### days); however, metabolic degradation occursvery slowlyin aerobic soil. Clothianidinis 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 amodest amount of leachingwas observed in the submitted field studies. Previous studies have confirmed that compounds with a 

### similar combination of mobility and persistence characteristics have a potential to leach to ground water at some use sites. Volatilization is not 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 study to accurately calculate the degradation rate over the 1-year study period (r2 = 0.05). A 

### total system half-life of 187 days was estimated from a 120-day aerobic aquatic metabolism study 

### (MRID46826903).

### Under anaerobic aquatic conditions, metabolic degradation occurred relatively quickly (half-life of 14

### days in water; 37 days in sediment; 27 days overall). Clothianidin was <I% of the applied in the water at and after 120 days and was <2.0% in the silt loam sediment at and after 183 days. No major degradates were isolated; clothianidin was converted primarily to soil-bound residues. Clothianidin photodegraded with half-livesof 

### <1 day in sterile buffer solution in the laboratory and in natural water outdoors, and approximately 34 days in soil in the laboratory. The range of values (1 to 34 days) given for surface water-source drinking water represents uncertainty with regard to the importance of photodegradation in the long-term fate of clothianidin in natural waters. In the laboratory, clothianidin photodegraded in sterile aqueous 

### pH 7 buffer solutions with a half-life of 6.2-6.8hours, based on a 12-hourlight.42-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- bl[l,2,5]thiadiazin-4-one (MIT), formamide (FA),and C02. Outdoors, clothianidin degraded in nonsterile river water with a half-life of 25.1 to 27.7 hours under a cycle of approximately 

### 9 hours sunlight115 hours darkness. Major transformation products were MG, 

### HMIO, MU, Urea, TMG, 3-methylamino-1 H-imidazo [1,5-c]imidazole (MAI), 2-chlorothiazol-5-ylmethanol (CTCA), and C02. There was no degradation in the control samples held in the dark, which is consistent with clothianidin's observed stabilitytohydrolysis. On moist soil, clothianidin photodegraded with a half-life of 8.2 days based on continuous irradiation (estimated to be equivalent to 34.2 solar summer days in Phoenix, AZ); degradation
was not significantin the dark. At study termination (equivalentto 71 days solar summer days in Phoenix, AZ), 22.3% of the clothianidin remained undegraded. No degradates accumulated to significant levels during the study.


### Soilsorption and mobility 

### In laboratory batch equilibrium studies, clothianidin had medium mobility in a US sandy loam soil and high mobility in US loamy sand and clay loam and German sand and sandy loam soils. In batch equilibrium studies using the same soils and similar conditions, MNG was very highly mobile, TZMU was highly to very highly mobile, TZNG was moderately mobile, and TMG was immobile or had low mobility. The mobility of clothianidin appeared to decrease as the length of time clothianidin was in contact with the soil increased; the longer clothianidin was aged in treated soil, the less likelyit was to desorb from that soil.

Field dissipution 

### Clothianidin is expected to dissipate very slowly under terrestrial field conditions, based on the results of five bare ground field experiments conducted in the 

### US and Canada. Half-lives of clothianidin, based on residues in the 0-15 cm soil depth, were 277 days (Wisconsin sand soil, incorporated), 315 days (Ohio silt loam soil, not incorporated), 365 days (Ontario silt loam soil, incorporated), and 1,386days (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. Clothianidin was generallynot detectedbelow the 45 cm soil

### depth except at one site, where it moved into the 45-60 cm depth. No degradates were detected at >lo% of the applied, and degradates were generally only detected in the 0-15 cm soil layer. However, in many cases most of the parent remained untransformed at the close of the study; further accumulation of degradates could have occurred. Degradates that were increasing in concentration or at least continuing to persist towards the close of one or more field dissipation studies were: MNG (MRID 45422336) 

### TZNG 

### (MRID 45422335, 45422333), and TZMU (MRID 45422335).

Two studies were conducted to investigate leaching of clothianidin under ficld conditions (MRIDS 45422331 and 45422508). These studies were conducted in the Federal Republic of Germany and were apparently designed to fulfill certain European regulatory requirements. In these monolith lysimeter studies, 42 to 59% of the applied remained in the soil approximately 3 to 4 years following the first of two applications, and residues were primarily undegraded clothianidin. The loss of radioactivity was attributed by the authors to mineralization of clothianidin, since 51%

### of the total residues were detected in the leachate. Clothianidin was not detected 

### in the leachate. There was also a significant amount of TZNG and/ or MNG that remained in monolith lysimeters at the close of multi-year studies. In one study (MRID 45422331), analysis of the soil in the lysirneter three years after the original application of clothianidin revealed TZNG was present as about 5% of the applied clothianidin. When the soil
was analyzed more than 4 years after application in another lysimeter study (MRID 45422508) about 

### 3% of the applied was present as MNG and 2% was present as TZNG. The substantial amount of clothianidin parent remaining in the soil profile at the close of these studies indicates that further leaching of clothianidin may occur in following years if sufficient precipitation
occurs. 

## 3.1 

## Aquatic Exposure Estimates

The aquatic exposure estimates presented in this assessment were based on the use of models as limited surface and ground water monitoring data are available for clothianidinl. To simulate the most conservative surface watcr exposure for the ecological risk assessment, the Tier 

### I1 PRZMEXAMS model was used.


### PRZM-EXAMS Model Inputs and 

### Scenarios

### for Clothianidin The Pesticide Root Zone Model, (PRZM, Carsel et 

### al., 

### 1997) and the Exposure Analysis Modeling System (EXAMS, Bums, 

### 1997) were used in tandem to generate aquatic estimated environmental concentrations (EECs). PRZM (3.12beta dated May 24, 2001) simulates fate and transport on the agricultural field whereas EXAMS (2.98.04, dated July 18, 2002) simulates the fate and resulting daily concentrations in the water body. Simulations are carried out with thc

I The primary but indirect exceptionto this are two Small-ScaleProspective Ground-Water Monitoring Studiesfor the related pesticide Thiamethoxam (thiamethoxam degradesreadily to clothianidin). MRID 473797-01 A Small-Scale Prospective Groundwater Monitoring Study for Thiamethoxam Insecticide (platinumm) in Macon County, Georgia.Report dated 1/16/2008. MRID474882.01. A Small-Scale Prospective Groundwater Monitoring Study for Platinum" 2SC (Thiamethoxam, CGA-293343) in St.Joseph County, Michigan.Report dated 6/6/2008.

### linkage program shell, EXPRESS (1.03.02, dated July 20, 2007). Simulations are run for multiple (usually 

### 30) years, and the EECs represent peak values that are expected once every ten years based on the thirty years of daily values generated during the simulation. Additional information onthese models can be found at: 

### http://www.epa.gov/op~efed1/models/water/index.htm and at: http://www.epa.

### ~ov/ceampubl/swater/index.html
The aquatic exposure is estimated for the maximum application pattern to a 10-ha field bordering
a 1-ha pond, 2-m deep (20,000 m3) with no outlet. Exposure estimates generated using this standard pond are intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man-made and natural ponds, and intermittent and first-order streams. As a group, there are factors that make these water bodies more or less vulnerable than the standard surrogate pond. Static water bodies that have larger ratios of pesticide-treated drainage area to water body volume would be expected to have higher peak EECs than the standard pond. These water bodies will be either smaller in size or have large drainage areas. Smaller water bodies have limited storage capacity and thus may overflow and carry pesticide in the discharge, whereas the standard pond has no discharge. As watershed size increases beyond 10-ha, it becomes increasingly unlikely that the entire watershed is planted with a non-major single crop that is all treated simultaneously with the pesticide. For major crops like cereal grains, however, this may not be the case. Headwater streams can also have peak concentrations higher than the standard pond, but they likely persist for only short periods of time and are then carried and dissipated downstream.


### OPP standard 

### PRZM crop scenarios, which consist of location-specific soils, weather, and cropping practices, were used in the simulations to represent proposed labeled uses of Clothianidin. These scenarios were developed to represent high-end exposure sites in 

### terms of vulnerability to runoff and erosion and subsequent off-site transport of pesticide. Model input parameters representing the proposed mustard and cotton seed treatment uses are provided in 

### Table 7 (further details on model input and output areprovided in the Appendix).

for this type of use. Mustard seed treatment is an entirelynew use. 

### Table 7. Input parametersfor

### PRZMIEXAMS forthe calculationof aquatic and benthic 

### EECs ofclothianidin.

Parameter(units) Output FileName Chemical Name Crop Names 

### VaIue(s) CLOTHIANIDIN Clothianidin Mustard seed treatment Cotton seed treatment 

### Sources

--- Label Label 

### Comments

..-
Cotton seed treatment is higher rale than previously registered

### Parameter(units) Application Rate

Day of Application (mm-dd)

Number of Applications Allowed at the Maximum Application Rate Minimum Interval between Applications (days) CAM (Chemical application method)

IPSCND (Flag indicating the 

### Value(s) lb a.iJa Mustard (NDCanola scenario) = 0.028 Ib ai1A Cotton (NC, MS, &CA scenarios) = 0.0633Ib ai/A

CACotton =04-24 MS Cotton =04-24 NC Cotton =05-25 ND Canola =05-09

1

N/A

5 or 8

disposition ofpesticide remaining 

### Sources Proposed Labels

Label

Label

Label

---

DEPI =Incorporation Depth (cm)

Koc

Aerobic Soil Metabolism (days)

Method of Application

- ~ufffer Zone (fF) Application Efficiency (fraction)

Spray Drift (fraction) 

### Comments

Regionally specific typical planting dates.

CAM 8 represents efficient uniform planting at the nominal depth. CAM 5 allows for someof the seed to be distributed above the target planting depth. Applies only if CAM =2 or3

Cotton = 1.27cm Mustard = 1.27 cm 160

745

Broadcast NIA 1

0 Label

MRID454223

MRIDs45422325 and45422326

Label Label

---

--- Typical minimum recommended planting depth The average Koc value (of 129, 345, 123,84 and 119),as per EFED guidance (1). The K, value represents better the mobility of clothianidin (relative standard deviation is smaller). Represents the 9oth percentile of the upper confidence bound
on the mcan of 9 half-life values. tli2=148, 239, 578, 1155,533,533,693,990,and 495days. Mean = 596 days, Std. dev. 321 days, tW,".,= 1.397for n=9. TheFugay soil was excluded because too little degradation occurred to accurately calculate ahalf-life. Proposed label Proposed label For seed treatment. the application efficiency is assumed to be 100%. For seed treatment, the spray drift value is assumed to be 0%.

### Aquatic EEC values derived from PRZMIEXAMS for each of the modeled crop scenarios are summarized in Table 

### 8 and the benthic (soil pore-water) concentrations are provided in Table 9. 

### Both high- and low-efficiency seedings were simulated: in the high efficiency simulation all of the seed is assumed to have been planted at the target depth (1.27 cm for both uses) whereas in 

### the low efficiency application seed density is highest at 1.27 cm but a lesser concentration of seed is assumed to settlein the soil at a lesser depth.?Acute aquaticexposure was estimated to be up to 3.0 ug/L for the cotton seed use and 

### 0.49 ug/L for the mustard seed use. The acute

Refer tothe PRZM user manual (http.//www.epa.gov/athens/uublicationslreportslSuarez600R05 1I IPRZM3.udf ) for further details. 

### 36 

### Comments 10Xthe actual solubility as per EFEDguidance (I ). Highest availablevalue.
3x single measured value Determined by multiplying the availablehalf-life (27 days) by 3 to account for the uncertainty associated with using a single value. EFED guidance(I).
Longest half-life of 34 days used instead of aqueous photolysis half-life because of demonstrated persistence in water and on soil surface exposed to sunlight. Lower value of

## -I day from natural water photolysis study was not used in the modeling for this assessment.

.-- At 20°C

At 20°C (Not used for model input) Default for pond scenario, as opposed to index reservoir.

--- EFED guidance (I) EFED guidance (I) EFED guidance (1)

EFED guidance (1) PRZMIEXAMS (version 2.1.)dated 10122109,available at http://www.epa.gov/oppefedIImodelslwaterlinputgarameter~guidance.htm 2. Sources for seeding rates and dates of application: Label directions andOPP internal compilations. 3. European Commission Health & Consumer Protection Directorate document, Clothianidin SANCOl10533/05,Jan 2005 

### Sources (3)

MRID 46826903

MRID45422330

MRID 454223 17 MRID45422323 (soil); 454223 18, 45222320, 45422322. 45422319, 45422321 (water)

MRlD 454223 17 (3)

Calculated

.--

---

---

-.-

---

---

--- parameters for I

### Parameter(units)

Solubility inWater (ppm)

Aerobic Aquatic Metabolism (days)

Anaerobic Aquatic Metabolism (days)

Hydrolysis at pH 7 half-life (days) Aqueous Photolysis (days)

MolecularWeight (glmole) Vapor Pressure (torrormrnHg)

Henry's Law Constant (~tm-m3/mol) Environment 

## I Field Size Runoff FEXTRC, Foliar extraction PLDKRT, Decay rate on foliage PLVKRT, Volatilization rate from foliage UPTKF, Uptake factor 1.All values were selected according 

### Value(s) 3270mgL

562

81

Stable
34

249.7
3,8xlo.]I Pa =2,9x10-~3 mmHg 2.9e-16 Atm-m3lmole pond298.e~~ EPAPond None 0.5 0 0

0 to the EFEDguidance on input

### concentration in the pore water was estimated to be up to 

### 1.90ug/L for the cotton seed use and 0.33 

### ugL for the mustard seed use. Chronic exposure estimateswere only marginally lower in both surface water and benthic pore water (consistent with the high environmental persistence of clothianidin observed in laboratory and field studies).



### Table8. Estimated Environmental Concentrations for Clothianidin in Surface Water.



# 1 SeedTreatment (high incorp.efficiency) 

# 1 - - 

### Scenarios

CA Cotton 

# I 0.14 

## 1 0.14 

### Peak

0.14
I I I MS Cotton NC Cotton ND Canola 

### 21-day Average

(mustard seed) 

### Seed Treatment (low incorp.eff~ciency) 60-day

### Average

1.47 1.57 0.26

CA Cotton MS Cotton NC Cotton ND Canola (mustard seed)



### Table 9. Estimated Environmental Concentrations for Clothianidin in Benthic (soil-pore) Water.

- 

### - Seed Treatment(highincorp.efficiency) 1.42 1.53 0.25

0.31 2.80 3.OO 0.49



### Scenarios

I I I 1.36 1.48 0.24

21-day

### Average Peak

CA Cotton MS Cotton NC Cotton ND Canola (mustard seed)

MS Cotton

I I

(mustard seed) 0.31 2.74 2.91 0.48

60-day

### Average

0.11 0.81 1.OO 0.17 0.11 0.81 1.OO 0.17



### We also estimated exposureto 

### organisms ingesting residues from sediment. Peak exposures for 0.30 2.62 2.82 0.46

0.11 0.80 1.OO 0.17



### SeedTreatment(lowincorp.efficiency)

I .US NC Cotton ND Canola 1.56 1.58

0.33 0.33 CA Cotton 1.58 1.90 0.33 0.22 0.22

1.89 0.21

### both application efficiency level assumptions ranged from 0.74 to 12.83ug / 

### g of sediment (again, chronic exposure levels were not significantly lower) - 

### see Table 10. Sediment residues normalized for organic carbon content ranged from 

### 0.5to 8.35ug 1

### g of sediment (peak or chronic exposure)- 

### see Table 1

### 1.

1 I I Seed Treatment: Pond Sediment Bound 1/10year EECs (lowincorp. efficiency) 

### Table 10. Estimated bound sediment concentrations for clothianidin.



# I --- ng/g (ppb)

# --- 

# i 60-day Average 21-day Average Scenarios

(mustard seed) Seed Treatment: Pond Sediment Bound 1/10year EECs (high incorp. efficiency) Peak

1.45 10.57 NC Cotton ND Canola



# --- ng/g (ppb)

## --- 

# I 1.46 10.66 CA Cotton MS Cotton 1.47 10.69 12.83 2.25



### Table 11. Ton soil/ 

### sedimentorganic carbon fractionbv PRZMIEXAMS scenario. CA Cotton MS Cotton NC Cotton ND Canola (mustard seed) 12.80 2.25 12.73 2.24

0.74 5.48 6.77 1.18

I Y 4

-- - - -- - -


### Table 12. Bound Sediment Concentrations for Clothianidin normalized to Organic Carbon Scenarios 0.74 5.47 6.77 1.18



### 0.0029 0.0128 

### 0.0232 0.0236 CA Cotton MS Cotton NC Cotton ND Canola

Pond sediment Organic carbon fraction assumed to be equal to the fraction uf organic carbon in horizon 1 for the associated PRZM scenario. 

### 3

### 8 0.74 5.43 6.75 1.17

Seed Treatment: Pond SedimentOrganic Carbon Levels, Cotton and Canola scenario$ Organic Carbon (Percent)



### 0.29% 1.28% 

### 2.32% 

### 2.36%



### content. Organic Carbon (Fraction)

Scenarios Peak 21-day Average 60-dayAverage

Seed Treatment: Pond SedimentBound 1/10year EECs (lowincorp. efficiency)


# --- nglg (ppb)

# --- CA Cotton 5 00 507 503

## 3.2 

## Terrestrial 

## Exposure Estimates Consumption of clothianidin-treated seed is the most likely exposureroute for terrestrial animals. The Terrestrial Exposure Model (Version 

### 1.4.1),was used to estimate the dietary exposure to terrestrial birds and mammals. Because of the differences in foliar application and seed treatment uses of pesticides, the seed treatment worksheet of TREX was used as a "stand-alone" tool for estimating the avian and mammalian exposureconcentrations for various crops. MS Cotton NC Cotton ND Canola (mustard seed)



### The seed treatment worksheet of TREX assesses dietary exposure in two different ways. The first approach estimates the dietary dose assuming that an organism has been eating only treated seed. Using this assumption, the seed treatment worksheet calculates the food consumed by birds and mammals using Nagy's allometric food consumption equations. Food consumption is calculated for the smallest avian (20-gram weight) and mammalian (15-gram weight) species 

### (AppendixA). Using a scaling factor approach, which adjusts food intake and toxicity values to account for the differences in the size of the animal assessed compared with the size of the animal used in the toxicity tests, daily doses or Nagy doses are calculated. Avian and mammalian Nagy doses for clothianidin were calculated using the equation - 

### (daily food intake glday 

## * 0.001

### kg/g 

## * maximum seed application rate mglkg-seed) 1body weight of animal (kg).

The second method calculates the available concentration of pesticide on the basis of pesticide applied per square foot. Maximum clothianidin application for each crop is converted to mg a.i./sq ft in order to derive an estimateofthe pesticide exposure per square foot. 835 553
95



### Typical input values (for foliar treatments) for TREX include application rate, time interval between two applications, total number of applications and foliar half-life periods. All seeding rate information was obtained from 

### U.S. 

### EPA, 2004b. Since clothianidin is a seed-treatment insecticide, terrestrial EECs were derived using 1 

### application for the maximum proposed use rates for each crop-The TREX model assumes a default density of 8.33 

### lblgal. This density was therefore used in the TREX model. Also, as clothianidin is a seed-treatment, foliar half-life periods are irrelevant for this analysis. Seed Treatment: Pond SedimentBound 1/10year EECs (highincorp. efficiency)


# --- nglg (ppb)

# --- 833 552
95

CA Cotton MS Cotton NC Cotton ND Canola (mustard seed) 826 549
95

255 428 292
50 255 427 292
50 255 424 291
50

# 4 

# Ecological EffectsAssessment The short-term and long-term exposure effects of clothianidin on aquatic and terrestrial organisms were characterized based on the studies submitted by the registrant only as the ECOTOX database review did not reveal any open literature studies for clothianidin that were relevant. Toxicity studies available for this risk-assessment and the measurement endpoints selected for each taxonomic group are included in

### Appendix 

### B of this document. 

## 4.1 Aquatic Effects Summary
4.1.1 Freshwater and Marine Fish

Two freshwater fish toxicity studies using the TGAI arerequired to establish the acute toxicity of clothianidin to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish 

### (a warmwater fish). The acute studies that were submitted that tested the parent compound showed that clothianidin is practically non-toxic to freshwater fish (LC5o>105.8 -1 17 

### pprn). Studies on degradates (TMG, MNG, and TZNG) indicated a similar practically non-toxic profile (LC5() >lo5 pprn). 

### EFED will use the worst case value (LC50 >105.8 ppm) for evaluating acute toxic exposureto freshwater fish.

A 

### freshwater fish early life-stage 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)

### clothianidin is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity; 

### (2) studies on aquatic invertebrates showed reproductive effects (daphnid 21-day LOAEC = 

### 0.12 ppm) and (3) 

### clothianidin is persistent in water (e.g., half-life of 744 days aerobic soil metabolism).

A chronic early life stage study conducted on the fathead minnow showed that exposure of 20 pprn has the potential to affect length and dry weight of freshwater fish. 

### The NOAEC of 9.7 

### pprn will be used forrisk assessment purposes.

The preferred test species is sheepshead minnow. The data submitted showed that the LC5, = 

### 93.6 ppm; therefore, clothianidin is categorized as slightly toxic to estuarinelmarine fish on an acute basis.



## 4.1.2 Freshwater and Marine Invertebrates

A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of clothianidin to aquatic invertebrates. The preferred test species is Daphnia magna. The data that was submitted that tested the parent compound showed that clothianidin is practically nontoxic to Daphnia magna with an acute48-hour ECsovalue of >I19ppm, but that it is very highly toxic to Chironomus riparius with an acute 48-hour EC50value of 0.022 ppm. 

### EFED will use the worst case value (ECSo= 0.022 ppm) for evaluating acute toxic exposure to freshwater

### invertebrates. Additional data (48-hourEC50) on degradates (TZNG,MNG, and TMG) indicated
apractically non-toxicto slightly toxicprofile (EC50=

### 64.0to >115.2pprn). Acute toxicity testing with estuarinelmarine invertebrates using the TGAI is required for clothianidin because the end-use product is expected to reach this environment due to its potential use on crops with significant acreage in coastal counties. Thepreferred test species 

### are mysid shrimp and eastern oyster. The data showed that clothianidin significantly reduced survival of mysid shrimp at 0.051 ppm, categorizing the compound as very highly toxic. Clothianidin was categorized as practically non-toxic to Eastern oyster because adverse effects did not occur for this species up to concentrations of 129.1 ppm. 

### EFED will use the worst case value, LCso=0.05 1ppm, for evaluating acute toxic exposure to estuarinelmarine invertebrates.

A freshwater aquatic invertebrate life-cycle test using the TGAI is 

### required for clothianidin because the end-use product may be transported to water from the intended use site, and the following conditions are met: (1) the presence of clothianidin in water is llkely to be continuous or recurrent and (2)aquatic acute LCsoor ECsovalues are less than 1pprn (i.e., 0.022 ppm), and 

### (3)physicochemical properties indicate that clothianidin is persistent in the aquatic environment (e.g.,half-life of 744 days aerobic soil metabolism). The preferred test is a 21-day life cycle on Daphnia magna. The data that were submitted show that clothianidin has the potential for chronic toxicity to daphnids and possibly other freshwater invertebrates. Exposure to 0.12 ppm can result in reproductive effects, including the reduced number ofjuveniles produced per adult. The NOAEC of 0.042 pprn will be used in assessing risk.

An estuarinelmarine invertebrate life-cycle toxicity test using the TGAI 

### is required for clothianidin because the end-use product is expected to transport to an estuarinelmarine environment from the intended use site, and the following conditions are met: (1)the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity, (2) an aquatic acute LCs0or 

### EC5() is less than 1pprn (e.g., mysid LCso=

### 0.051 pprn), and (3) 

### studies 

### of other organisms indicate that the reproductive physiology of fish andlor invertebrates may be affected, physicochemical properties indicate cumulative effects, or the pesticide is persistent in water (e.g.,half-life of 744 days aerobic soil metabolism).

Thepreferred test species is mysid shrimp. Thedata submitted indicatethat clothianidin reduced the number of young per reproductive day at 9.7 ppb. The NOAEC of 5.1 ppb will be used in assessing risk.

Two studies were submitted that assessed toxicity to sediment dwelling freshwater and estuarinelmarine invertebrates. One study (MRID 46826902) assessed the toxicity to the midge (Chironomus riparius) during a 10-Day sediment exposure. This study revealed an LCs0of 11 ppb and a 

### NOAEC 

### of 1.1ppb based on pore water concentrations. It also showed an LCso based on mean-measured sediment concentrations (OC normalized) of 12.91 mg/kg TOC and a NOAEC of 1.65 mg ailkg TOC. The other study (MRID 47199401) evaluated a 10-day whole

### sedimenttoxicity test with Leptocheirusplumulosus 

### using spiked sediment. This studyrevealed
an LCsoof 20.4 ppb and a NOAEC of 11.6 

### ppb based on pore water concentrations. It also revealed an LC5()of 315 

### yg ailkg TOC and a NOAEC of 204 yg ailkg TOC 

### based on meanmeasured sediment concentrations(OC normalized). Therefore, clothianidinis very highly toxic to sediment dwelling aquatic invertebrates.
Calculations for sediment exposure to benthic organisms followed the equilibrium partitioning model as noted in Appendix 

### D and applied in a previous risk assessment for cypermethrin (DP289427). The pore water based endpoints were measured in the studies, however the sedimentbased endpoints (OC normalized) are a function of the whole sediment LC50 divided by the proportion of organic carbon in the sediment. PRZM-EXMS provides both pore water and sediment concentrations (which were also adjusted based on the sediment concentration divided by the proportion of organic carbon in the sediment), so these values provided a direct comparison to the endpointsderived fromthe studiesnoted above.
Chronic toxicity studies in benthic organisms were not submitted. To assess chronic risk to benthic organisms, chronic toxicity values were derived for both sediment and pore water. The chronic NOAEC estimated for benthic organisms in terms of yg a.i.kg sediment is based on the acute-to-chronic ratio method, determined by the following mathematical relationships :


### Freshwater invertebrateLCs0(22 pg a.i./L) 

## 1 Freshwater invertebrate NOAEC (42 yg a.i./L) =

### Benthic LCSo in sediment 12.91mg a.i./kg sediment (OCnormalized)/ 

### X (estimated benthic NOAEC value in sediment), where 

### X =

### 24,600 pg a.i./kg TOC.

Estuarinelmarine invertebrateLC50 

### (51pg a.i./L) 1Estuarinelrnarine invertebrate NOAEC (5.1 pg a.i./L) =

### EstuarinelmarineBenthicLC5()in sediment 315pg a.i./kg sediment(oc normalized) 

## 1X (estimated benthic NOAEC value in sediment-oc normalized), where 

### X = 

### 31.5y

### g a.i./kg TOC.

The chronic NOAEC estimated for benthic organisms in units of yg 

### a.i.kg pore water is based on the acute-to-chronic ratio method, determined by the following mathematical relationships:

Freshwater invertebrateLCso(22 yg 

### a.i./L) 

### 1 Freshwater invertebrate NOAEC (42 yg a.i./L) =

### Benthic LCsoin pore water (1

### 1yg

### a.i./L)/

## X (estimated benthic NOAEC value in pore water ), 

### where 

### X =

### 21 pg a.i./L pore water.
Estuarinelrnarine invertebrateLCSo 

### (51pg a.i./L)/ 

### Estuarinelrnarine invertebrate NOAEC (5.1 pg a.i./L) =

### BenthicLC5() in pore water (20.4 pg a.i./L) 1

### X (estimated benthic NOAEC value in pore water ), 

### where 

### X =

### 2.4yg a.i./L pore water.

### No chronictoxicity tests onclothianidin formulations orclothianidin degradates in freshwater orestuarinelmarine benthic organisms were submitted.



## 4.1.3 

## Aquatic Plants

Several aquatic plant toxicity studies using the TGAI are required to establish the toxicity of clothianidin to non-target aquatic plants. The recommendation is for testing on five species: freshwater green alga (Selenastrum capricornutum), 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 exposureto clothianidin at levels greater than or equal to 3.5 pprn reduced biomass of aquatic non-vascular plants and increased the incidence of necrotic fronds in aquatic vascular plants. Studies on degradates (TMG, MNG 

### and TZNG) showed reductions in green algal cell density when exposed to levels >1.46ppm. The ECsoof 64 pprn will be used for evaluating acute toxic exposure to non-target aquatic plants. EFED needs 3 

### more Core clothianidin studies for the nonvascular surrogate species, marine diatom (Skeletonema costatum), blue-green algae (AnahaenaJlosaquae), and a freshwater diatom.



## 4.2 

## Terrestrial Effects Summary

4.2.1 

## Toxicity Effects on Terrestrial animals An extensive assessment of the potential exposure and risk to avian guideline species exposed to clothianidin by oral intubation or in the diet concluded that clothianidin was moderately toxic to bobwhite quail on an acute basis (LD50> 200 mglkg) and non-toxic to the mallard duck and bobwhite quail on a sub-acute basis 

### (5 day 

### LC50 >5040 pprn and 

### 5230 pprn), respectively. The submitted chronic toxicity data show that exposure of 

### 525 pprn of clothianidin in the diet adversely affected eggshell thickness (MRID45422421).
Likewise, an assessment of potential exposure and risk to small mammals exposed to clothianidin by the oral route suggests that clothianidin is moderately toxic to small mammals on
an acute oral basis (mouse 

### LD50 = 389 

### to 465 mglkglday). Reproduction studies in rats indicate that concentrations of 

### 500 pprn clothianidin resulted in increased stillbirths and delayed sexual maturation in males. Developmental studies in rabbits indicate that concentrations of 

### 75 mg/kg/day resulted in premature deliveries, decreased gravid uterine weights, and increased litter incidence of missing lung lobeslfetus. 

## 4.2.2 

## Toxicity Effects on Invertebrates Currently, 

### EFED does not assess risk to nontarget insects or terrestrial invertebrates using the risk quotient method. However, it appears that clothianidin exposure to honeybees has the potential for high toxicity on both an acute contact and oral basis. Acute toxicity studies to honey bees show that clothianidin has the potential to be highly toxic on both a contact and an

### oral basis (contactLD50 =

### 0.044 yghee;oral LD50 =

### 0.0037 pghee), while its degradates (e.g.,, TMG, MNG, TZMU, and TZNG) are moderately to practically non-toxic on an oral basis (LD50



### = 3.9 - 

### >I53 ygtbee). One honey bee field study (MRID # 

### 45422435) showed that mortality, pollen foraging activity, and honey yield were negatively affected by residues of clothianidin; however, residues were not quantified in this study. Another honey bee field study (MRID 45422440) showed that pollen treated with clothianidin at a measured concentration level up to 19.7 yg a.i./kg produced no significant adverse effects to mortality, foraging activity (including pollen and honey collection), comb production, honey storage behavior, population growth (including egg, larvae, pupae, and adult growth stages), and behavioral anomalies. However, only one replicate hive per treatment level was tested, therefore, statistical analysis of the data could not be performed.

Subchronic invertebrate toxicity studies showed that clothianidin adversely affected earthworm mortality and body weight (LC50 = 

### 15.5ppm) and its degradates reduced body weight (LC50 = 

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

## 4.2.3 

## Toxicity Effectson Terrestrial Plants Terrestrial Tier I1 studies are required for all low dose pesticides (those with the maximum use rate of 0.5 Ibs a.i./A or less) and for any pesticide showing a negative response equal to or greater than 25% in Tier 

### I studies. Two Tier I 

### terrestrial plant toxicity studies were conducted to establish the toxicity of clothianidin to non-target terrestrial plants. The recommendations for seedling emergence and vegetative vigor studies are for testing of 

### (1) six species of at least four dicotyledonous families, one species of which is soybean (Glycine max) and the second of which is a root crop, and 

### (2) four species of at least two monocotyledonous families, one of which is
corn (Zea mays). The studies that were submitted tested formulated products of clothianidin (49.3% TI-435 50% WDG). The results of these studies showed that exposure elicited no effect (that is, 

### 2 25%) on non-target terrestrial plants, so Tier 11

### tests were not necessary.



## 4.3 

## Incident Database Review

One incident was report inthe EIIS, which was related to toxic effects to terrestrial invertebrates. The incident (1019743-001) involved hundreds of thousands of honeybees and was listed as highly probable, indicating that exposure to clothianidin was the llkely cause of death. According to a press release by a German government agency (BVL) and various news reports, beekeepers in Baden-Wurttembergregion of Germany had reported that two-thirds of their bees died in May 2008following the application of a pesticide called clothianidin. Tests on dead bees showed that almost all of those examined had a build-up of clothianidin. The chemical, produced by Bayer Cropscience, is sold in Europe under the trade name Poncho. The seeds were treated in advance ofbeing planted or were sprayed while in the field.The company said an application error by the seed company, which failed to use the glue like substance ("stickers") that sticks the pesticide to the seed,led to the chemical being dispersed into the air. Clothianidin is a systemic chemical that works its way through a plant and attacks the nervous system of any

### insect it comes into contact with and it is highly toxic to honeybees. The German Office for Consumer Protection and Food Safety has ordered the immediate suspension of the approval for eight seed treatment products including clothianidin as well as the related neonicotinoid ingredients imidacloprid and thiamethoxam, and the carbamate methiocarb. Germany temporarily pulled the registration for these seed treatments because of these incidents and the result of their studies. Investigations of bee kills determined that use of a particular type of pneumatic drilling equipment with treated seeds was causing ahigh exposure to bees. It appears that poorly applied corn seed treatments, together with physical abrasion of the treated seed by the pneumatic planters, led to dust clouds of pesticides being formed. These dust clouds drifted ontoneighboring crops where bees were foraging.


# 5 

# RiskCharacterization Risk characterization is the integration of exposure and effects to determine the ecological risk from the use of such stressors as clothianidin. Therisk characterization provides estimations and descriptions of the risk; articulates risk assessment assumptions, limitations, and uncertainties; synthesizes 

### an overall conclusion; and provides the risk managers with information to make regulatory decisions. 

## 5.1 

## Risk Estimation The risk quotient 

### (RQ) method was used to provide a metric for potential adverse ecological risks from the proposed uses of clothianidin. The risk quotient, a comparison of exposure estimates and toxicity endpoints, is estimated by dividing exposure concentrations by acute or chronic toxicity values (Appendix 

### C). Theresulting unitless RQs are compared to the Agency's levels of concern (LOC) to determine theneed for regulatory action.

These LOCs are criteria used by 

### OPP to indicate potential risk to non-target organisms and the need to consider regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on non-target organisms. LOCs currently address the following risk presumption categories: (1) 

### acute 

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

### (2) acute restricted use 

# - 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 ishigh, regulatory action may be warranted, and (4) chronic 

### risk

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

### EFED does not perform assessment for chronic risk to plants, acute or chronic risks to non-target insects or chronic risks from granularhait formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies. Examples of ecotoxicity values derived from results of short-term laboratory studies that assess acute effects are (1) LCso(fish and birds), (2) 

### LDso(birds and mammals), (3)

### ECso(aquatic plants and aquatic invertebrates, and (4)EC15(terrestrial plants). An example of a toxicity test effect level derived from the 

### results of
a long-term laboratory study that assesses chronic effects is (1)NOAEC (birds, fish, and aquatic invertebrates). Risk presumptions, along with corresponding RQs and LOCs are tabulated in

### Appendix 

### B.



## 5.1

## .I Aquatic Risk 

## Quotients The proposed seed treatments did not appear to pose an acute or chronic risk to either freshwater
or saltwaterlestuarine fish 

### (Table 

### 10). However, chronic risk to saltwaterlestuarine fish could not be evaluated due to a lack of data on these taxa. 

### h two of the scenarios, Mississippi and North Carolina cotton, the new uses pose acute risk to threatened and endangered freshwater invertebrates for both low efficiency and high efficiency incorporation applications. Only the low efficiency incorporation scenario with Mississippi and North Carolina cotton pose acute risk to threatened and endangered estuarinelmarine invertebrates. Regarding chronic risk to aquatic invertebrates, only two scenarios showed risk in the high efficiency incorporation scenarios: the Mississippi and North Carolina cotton scenarios with risk to estuarinelmarine invertebrates. However, with low efficiency incorporation there was risk in all scenarios to estuarinelmarine invertebrates and risk to freshwater invertebrates in the North Carolina and Mississippi cotton scenarios.



### Table 13. 

### Summaryof aquatic risk quotientsfor 

### fish and aquatic invertebrates based on surfacewater

### EECs. 

### LOCexceedancesarein bold.

### Risk to sediment dwelling freshwater and estuarinelmarine invertebrates was assessed using the methods established for cypermethrin 

### (DP289427)and described in section4.1.2. Acute risk is a function of the peak pore water and organic carbon normalized sediment concentrations from 

### PRZM-EXMS and the corresponding LCsoidentified in the studies. Chronic risk is a function of the average 21 day OC normalized sediment bound concentration and the corresponding estimated chronic LCsovalues also described in section 4.1.2. ND Canola (mustard)



### The proposed uses result in acute risk to aquatic benthic invertebrates through exposure to both pore water and sediment bound OC normalized concentrations of clothianidin for cotton and mustard 

### (Tables 11 and 

### 12). Risk was present for both low efficiency and high efficiency application scenarios. However, chronic risk was only found for estuarinelmarine invertebrates I~cute RQs are based on the peak EEC 'chronic RQs arebased on the 21-day averageEEC for invertebrates and the 60-day averageEEC for fish 3~~'s exceedthe threatened and endangeredaquatic invertebrateLOC of 0.05 N/A



### exposed to sediment bound residues, but risk was present for all application scenarios 

### (Table 13). 4.74E-05 0.09413



### Table 14. Summary of aquatic acuterisk quotientsforbenthic aquatic invertebratesbased 0.0114



### Table 15.

### Summaryofaquaticacute risk quotientsfor benthic aquatic invertebratesbased
on sedimentbound (organiccarbon normalized)EECs. Potential

### LOC exceedances are in bold. 0.03 0.3' 0.0162 0.0284



### Crop 

# I BenthicAquatic Invertebrate

### Risk~uotients' High Efficiency 

# 1 AcuteRQsfor 

# I SublethalRQs for 

### ( Acute RQsfor 

## I SublethalRQs for LowEfficiency

Incorporation

CA Cotton MS Cotton NC Cotton ND Canola (mustard) 

## cute RQs arebased on the peak pore-waterEEC and the LCs0.Sublethal RQs are based on the peak pore-water EEC for invertebrates and the NOAEC. 'RQS exceed the threatened and endangered aquatic invertebrateLOC of 0.05 'RQS exceed the acuterisk LOC of 0.5 and the endangered species LOC of 0.05 AcuteRQs for

Freshwater Invertebrates 0.0222 0.197~ 0.225' 0.0374 SublethalRQs for Freshwater Invertebrates 0.222~ 1.97~ 2.253 0.374' Acute RQsfor EstuarineJMarine

Invertebrates 0.01 19 0.106' 0.121' 0.0201 SublethalRQs for EstuarineIMarine

Invertebrates 0.0210 0.187~ 0.214' 0.0354

### Table 

### 16.Summaryofaquatic chronic risk quotientsfor benthicaquatic invertebrates based on sediment bound (organic carbonnormalized)EECs. Potential 

### LOC exceedances

Incorporation

CA Cotton MS Cotton NC Cotton
(mustard)
Low Efficiency

Incorporation

CA Cotton MS Cotton NC Cotton ND Canola (mustard)



### are

### in bold. Estuarinemarine Invertebrates 0.810~ 1.36~ 0.926~ Estuarine/Marine Invertebrates 1.25~ 2.10~ 1.43~ Freshwater Invertebrates 0.0198 0.0332 0.0226



## c cute RQs arebased on the peak OC normalized sedimentbound EEC and the OC normalizedLC50. Sublethal RQs arebased on thepeak OC normalized sedimentbound EEC for invertebratesand the OC normalized NOAEC. 2~~s exceed the threatened and endangered aquatic invertebrateLOC of 0.05 3~~s exceed the acute risk LOC of 0.5 and the endangered speciesLOC of 0.05 0.00387 Acute RQs for

Freshwater Invertebrates 0.0393 0.0647' 0.0428

0.00738



### 1 ND Canola 

### I 1 1 I I Freshwater Invertebrates 0.155~ 0.259' 0.177'

MS Cotton 0.0303 SublethalRQsfor Freshwater Invertebrates 0.307' 0.506~ 0.335'
0.0578'

0.0386 

# 1 0.0174

(mustard) 

### - Low Efficiency Incorporation

CACotton



### 1 ND Canola 

### I I 

## I I 1 0.159' Acute RQs for EstuarinelMarine

Invertebrates l.613 2.65j 1.75~
0.303'

- -MS Cotton 0.245' SublethalRQs for EstuarineIMarine

Invertebrates 2.483 4.09~ 2.713
0.467'

0.337 NC Cotton

0.00809 Freshwater Invertebrates

# -

Pore Water 0.0105

chronicECS0 'ROS exceed the chronicLOC of I 13.6~ 0.01 19 0.0476

0.0752

(mustard)



### Risk to vascular and non-vascular plants was negligible. Using data on Lemna gibba 

### and the most sensitive algal species, Selenastrum capricornutum, 

### RQ's ranged from 0.00205 for listed non-vascular plants and 5.08E-05 for listed vascular plants in the most conservative scenario for low efficiency incorporation applications. Neither of these values, which represents the maximum RQ's that canbe expected, exceeds the endangered aquatic plant LOC 

### of 1. 0.00203 Freshwater Invertebrates

# - Sediment Bound 0.0205

NC Cotton 0.4 17

0.0338

'RQSarebased on the 21 day pore-water and OC normalized sedimentbound residue EEC and the estimated 0.0157 9.26'

0.0708 Estuarinemarine Invertebrates

## -Pore Water 0.0917

0.0900 1.59' EstuarineIMarine

Invertebrates

## - Sediment Bound 16.0' 0.658

0.00387 - 26.4' 0.0224

0.137 0.787
3.03' 17.5'

## 5.1.2 

## Terrestrial RiskQuotients Table 

### 14 summarizes the acute and chronic avian and mammalian RQs. Two scenarios were modeled for birds and mammals. The first scenario is based on the lack of a specific method of incorporation in the label language. In this scenario, 100% availability of the treated seed was assumed based on a broadcast application without incorporation or minimal incorporation. In this scenario, maximum avian acute RQ's ranged from 2.67 to 

### 3.06 for cotton and mustard, respectively, and chronic RQ's ranged from 17.07 to 19.51. These RQ's result in risk to listed on non-listed birds. Maximum mammalian acute RQ's ranged from 1.64to 1.87 for cotton and mustard, respectively, and chronic RQ's ranged from

### 23.33 to 26.67. These RQ's also result in risk to listed and non-listed mammals. However, under the second scenario in which an incorporation method is specified (i.e. T-Banded - 

### covered with specified amount of soil, Infurrow, drill, or shanked-in) the resulting RQ's showed a maximum value of 0.03 for acute risk and 0.27 for chronic risk, neither of which result in risk to listed ornon-listed birds or mammals. Currently, 

### EFED does not assess risk to non-target insects. Results of acceptable studies are used for recommending appropriate label precautions. Available registrant submitted studies for the honey bee indicated that clothianidin is highly toxicto bees. While bees will generally not be exposed to clothianidin residues through direct contact due to the seed treatment, exposure to contaminated pollen and nectar could not be evaluated. Therefore, 

### EFED cannot pedict risk in any capacity towards insects.


### Table 17.

### Summary of Terrestrial Acute 

### and Chronic Risk Quotients. Values 

### in bold represent an exceedenceof the respectiveLOC. Amle

### h-Brtsed

### RQs 

## I ChronicRQS~ 

### MammalianRQs 23.33



## 5.2 

## Risk 

## Description cotton5 Mustard4

oilseed) Mustard5 

### (condiment,

oilseed)



### Theresults of this baseline risk assessment show that the proposed new uses may pose acute risk 

### to both freshwater and saltwater invertebrates. The results also indicate that the proposed uses for clothianidin may pose risk to both non-listed and listed mammalian and avian taxa, 0.03



### oi cute RQs for birds and mammals aredetermined by dividing the estimated dietary intakes (mglkg-bwlday)by a body weight adjusted avian 

### LD50 of 1333mgkg-bw for mallard duck and a body weight adjusted mammalianLDjo of 5000 mg/kg-bw for the rat. 

## cute RQs were based onpesticide applied per square foot (mg a.i./ft*/L~~~*bw) 'chronic RQs were based on clothianidin seed application rate (mg a.i./kg seed) divided by adietary-based NOAEC (550mglkg-diet for the mallard duck and a 200mag-dietfor the rat). 4RQ's based on broadcast application ~ith 100% availability of application rate on seeds. 'RQ's based on specified incorporationmethod and 1%availability of application rate on seeds. 0.03 

### (condiment, 3.06 0.00

0.00 0.04 0.02

0.02 1.87 0.00

0.00 0.04 0.17

0.02 0.23

19.51

0.27 26.67

### depending on the presence or absence of protective label language. Therefore, the hypothesis is supported that clothianidinhas the potential to compromise survival and cause sub-lethal effects in non-target species. Risk to non-target beneficial insects cannot be assessed, but will be qualitatively discussed in the following sections.


### 5.2.1 

## Riskto Aquatic Organisms The available data on clothianidin show that the compound is relatively persistent to very persistent under most circumstances. Clothianidin is stable to hydrolysis at all pH's at environmental temperatures, moderately to highly stable under aerobic soil metabolism conditions (half-lives range from 148-6,900 days), and shows moderate stability under anaerobic aquatic metabolism (half-life of 27 days for the overall system). Laboratory data suggests that photolysis appears to play a role in the dissipation of the chemical (half-life of 14.4 hours in sterile water, 25.4 hours in natural water, and 34 days on soil). Clothianidinhas medium to very high mobility in soils. The fact that the KOC's of four of the five soils were of similar order of magnitude (range 84-129) indicates that there may be a correlation of the mobility with the organic carbon content of the soil. Certain degradates appeared to accumulate in some soils under some conditions [e.g., TZNG MNG, NTG, (aerobic) and TMG (anaerobic)]; over the very long term significant contamination of soil and water with these products might occur. The terrestrial field dissipation studies confirm the findings in the laboratory studies. Clothianidin was found to be persistent in the field (half-lives of 277 days, 1,400 days, and too high to calculate). Based on the overall picture that the laboratory and field studies provided, EFED concluded that there is a very high likelihood that clothianidin would persist and accumulate from year to year after repeated uses.

The potential impact to water quality from the use of clothianidin appears to be most likely due to the parent compound. The laboratory studies indicate that clothianidin is initially labile and then relatively persistent under most environmental conditions. This makes the chemical available for lengthy periods of time for runoff and exposure to aquatic environments. The impact of clothianidin to aquatic environments will also be affected by its mobility. The available studies indicated that clothianidin is persistent and mobile, stable to hydrolysis and has potential to leach to ground water and be transported via runoff to surface water, and will accumulate and persist in soils. Non-target aquatic organisms (freshwater and estuarinelmarine fish and invertebrates) can be exposed to clothianidin from the proposed uses mainly by runoff into surface water. EFED's risk assessment suggests that toxic risk to freshwater and estuarinelmarine fish appears low. Acute, restricted use, and endangered species acute and chronic levels of concern for freshwater and estuarinelrnarine fish were not exceeded for the application rates and uses evaluated. Chronicrisk to estuarinelrnarine fish could not be evaluated in this assessment due to the lack of data on this taxa. Given the low level of chronic toxicity of freshwater fish as well as the low acute toxicity of estuarinelmarine fish, as well as the resulting very low RQ 

### values to these taxa, it appears unlikely that the proposed uses of clothianidin would pose a chronic risk to estuarine and marine fish.
The proposed uses for mustard did not result in acute or chronic risk to either freshwater or

### estuarine/marine free-swimming invertebrates, except in the low efficiency incorporation where chronic risk was found for estuarine/marine invertebrates. However, the proposed cotton use in two of the scenarios, North Carolina and Mississippi, posed acute risk to freshwater invertebrates in both the low efficiency and high efficiency incorporation methods. Only the low efficiency incorporation method posed acute risk in the same scenarios to estuarine and marine invertebrates, suggesting that the method of incorporation is important in determining risk to these taxa. Chronic risk to free-swimming estuarinelmarine invertebrates was present in all of the cotton scenarios with low incorporation efficiency, but only in North Carolina and Mississippi with high incorporation efficiency. High incorporation efficiency eliminated chronic risk to freshwater free-swimming invertebrates.

The clothianidin toxicity threshold is low for freshwater benthic invertebrates on an acute basis,
so their vulnerability represents acute potential risk from accumulations of clothiandin in sediments. 

### A comparison of peak EECs, both pore water and sediment bound residues, with the LCs0(mortality) and the 

### NOAEC (sublethal) reveals that the proposed uses have the possibility of acute toxic risk to non-endangered and endangered freshwater and estuarinelmarine benthic invertebrates, via runoff especially if repeated uses occur 

### (Table 12). The acute risk, based on both lethal and sublethal effects, to estuarine/marine benthic invertebrates was independent of the region and the incorporation efficiency when exposure occurs via sediment bound concentrations. Chronic risk to this taxa also shows a similar result. This conclusion suggests that the application rates would need to be amended or other mitigation options that would reduce run-off arerequired to refine therisk any further.



### 5.2.2 

## Riskto 

## Terrestrial Organisms EFED's risk characterization of terrestrial animals focused on the potential for acute and chronic toxic risk from exposure to residual clothianidin after application. Based on proposed application rates and uses, acute risks is possible to terrestrial small birds and mammals. Results from exposure modeling of representative species indicatesthat acute (small birds and mammals) and chronic (birds and mammals) RQs exceed LOCs.

The exceedences and thus the risk are only present when no label language specifies the incorporation method. Given no incorporation or only minimal incorporation, the proposed uses for mustard and cotton pose an acute and chronic risk to birds and mammals. Incorporation of the treated seeds into the soil by certain methods as modeled in TREX eliminated all of the risk to both birds and mammals in the risk picture. According to current modeling approaches in EFED using TREX, the modeling assumptions for the various incorporation methods are as follows in terms ofpercent a.i. still available on the seeds that couldbe forage:

T-Banded -

### covered with specified amount of soil: 1% 

### In-furrow, drill, or shanked-in: 1% Side-dress, banded, mix, or lightly incorporate with soil: 15% Broadcast, mix, or lightly incorporated: 15% Side-dress,banded, unincorporated: 100% Broadcast, aerial broadcast, unincorporated: 100%

### These modeling assumptions illustrate the typical types of seed incorporation that can best mitigate any risk tobirds and mammals.

Another source of potential concern is the uncertainty surrounding clothianidin's possible role as an endocrine disrupter as noted from mammalian developmental and reproductive effects. This issue is compounded by the fact that clothianidin is an analog of nicotine and that studies in the published literature suggest that nicotine, when administered, causes developmental toxicity, including functional deficits, in animals and/or humans that are exposed in utero. Mammalian data shows that exposure to clothianidin can result in developmental effects (rabbit) that include premature deliveries, decreased gravid uterine weights, and increase incidence of missing lung lobe in fetus. The mammalian data also suggests that chronic toxicity in mammals can be manifested as systemic effects that can include decreased body weight gains and delayed sexual maturation (males only); decreased absolute thymus weight in F1 pups (both sexes), and increased stillbirths (Fl and 

### F2 litters). Reproductive effects were also noted for adult rats that included decreased sperm motility and increased number of sperm with detached heads. Although these effects did not reduce rat fecundity, they do raise an uncertainty as to possible reproductive effects to other species that may have a more limited (less frequent) reproductive capability.

Accumulation of clothianidin in soils as the result of multiple applications and repeated or continuous exposure may adversely affect soil invertebrates. Subchronic invertebrate toxicity studies showed that clothianidin adversely affected earthworm mortality and body weight (LC5o

= 

### 15.5ppm) and its degradates reduced body weight (LC5o= 

### 982.6 ppm). Additional testing (chronic study) or modeling may be needed to determine if soil invertebrates are at risk from repeated uses of clothianidin. Although 

### EFED does not do a risk assessment on non target insects, information from standard tests and field studies, as well as incident reports involving other neonicotinoid insecticides (e.g., imidacloprid) also suggest the potential for long term toxic risk to honey bees and other beneficial insects. Other neonicotinoid compounds like imidacloprid (e.g., sunflower seed treatment) have resulted in incidents to honey bees. The National Union of French Beekeepers had concerns regarding imidacolprid (GAUCHO) seed treatment to sunflowers after beekeepers noted that honey bees were showing modifications of behavior that were reflected in foraging and orientation that eventually resulted in a drastic change in hive conditions and bee survival. Further research by the Le Centre Technique Interprofessional des Oleagineux (CETIOM) confirmed imidacloprid toxic residue levels in the sunflower nectar. This action has prompted France to ban the use of imidacloprid for sunflower seed treatment. Since clothianidin has a similar toxicity profile as imidacloprid and is a member of the same family of compounds, there is uncertainty regarding the toxic risk to honey bee development and foraging behavior, as well
as the welfare of the queen from long term exposure to clothianidin residues that can be stored in the hive in honey andlor pollen.

A previous field study 

### (MRID46907801146907802) investigated the effects of clothianidin used
as a seed treatment on whole hive parameters and was classified as acceptable. However, after

### another review of this field study in light of additional information, deficiencies were identified that render the study supplemental.

In this field study, control and treated plots were each 1 hectare in size and paired, sothat 4 sites
were established with a control plot paired with a treated plot. These plots were separated by a minimum of 250 m. The study author states, 

### "Of 

### 23 back-up control nectar samples, 2 (field EIC, July 7; field W3C, July 7) had detectable clothianidin residues, at a maximum of 0.922 ppb, suggesting that workers in control colonies may have foraged on clothianidin-treated canola. This may have occurred because the separation between some pairs of control and treated fields was insufficient or because the forage in some control fields was of lower quality..

## ." The inverse may also have occurred. That is, bees placed on treated fields likely foraged on the control fields, which would have reduced the level of exposure to clothianidin residues due to a 

### lack of separation between sites. Bees have been shown to forage up to 6 km (Visscher and Seeley, 1982) or even twice that in some instances when no competing forage is present (Ratnieks, 2000). The distance of 250 m is inadequate for this separation. The inadequacy is evident given contamination in some of the nectar samples taken from control hives.
Furthermore, the study authors state that, "Approximately 

### 5 g 

### of pollen was analyzed under a light microscope, which confirmed that bees foraged on canola, while the remainder.. .". 

### This type of identification simply identifiesthat canola was present in the pollen samples, but does not quantify the proportion of canola pollen present in the sample. This type of pollen evaluation does not characterize the foraging of the bees. The bees in the treated fields could have foraged disproportionately on other uncontaminated sources relative to bees in the control fields. Furthermore, the study authors simply state that to their knowledge, no other forage was present with a radius of 1km from the edge of the fields. However, given the ability of bees to forage long distances, this lack of data leaves uncertainty in the exposure and suggests that this study did not provide the worst case exposure scenario necessary foruse in characterizing risk.

An addendum 

### (MRID 46907802) was submitted later that presented the results of the overwintering part of the study, which revealed that the majority of the hives, including those exposed to clothianidin during the previous season, survived the overwintering period. However, the cross-contamination in the control hives prevents a comparison between the control hives and the treated hives as they relate to whole hive parameters in this addendum. Therefore, this study can only be used to provide a qualitative description of hive survival following the exposure to clothianidin at the levels that were described 

### in the study.

It does not satisfy the guideline 850.3040, and another field study is needed to evaluate the effects of clothianidin on bees through contaminated pollen and nectar. Exposure through contaminated pollen and nectar and potential toxic effects therefore remain an uncertainty for pollinators. Further studies are needed to determine the toxicity to honeybees from seed treatment applications. Bayer has submitted 

### an interim report 

### (MRID 477987-01) on a study they are conducting in Austria. According to the report, the objective of the study was to investigate the frequency at which maize seedlings exude guttation fluid and to assess the relevance of guttation fluid to

### honeybees. Although not specifically mentioned in the text of the report, the study material appears to be clothianidin (based on one of the report figures). Over the two study areas, roughly 83%

### of the maize seedlings exuded guttation liquid. According to the report 16% of the assessment days at which guttation fluid was observed, honeybees were present when no alternative water supply was available; however, when alternative water was available, the honeybee visitation rate was 4%. 

### Clothianidin residue levels in bees were greater than the level of quantification up to 14 

### days after seedling emergence; in bees without alternative water supply, honeybee mortality appeared to be correlated with clothianidin residues; however, the number of bees for which this relationship existed is uncertain. The study authors state that despite an increased bee mortality in some hives for 1 - 

### 3 

### days during the survey, the overall development ofthe hives was not adversely affected by guttation fluid even under realistic, worst
case exposure conditions.
This is an interim report and it does not contain sufficient detail or raw data with which to understand the study. The methods section does not describe the placement of colonies with and without water, nor is it possible to determine what bees were actually foraging on during the study period. It appears from the study that at least some of the bees did take advantage of the guttation liquid and that they were exposed to clothianidin. In some cases, bees exhibited behavioral effects and increased incidence of mortality that appeared to be associated with elevated clothianidin residues.

Clothianidin is a neonicotinoid insecticide that is relatively persistent in the environment; the compound is intended tobe systemic in plants and the extent to which residues may be present in various plant tissues from seed treatments is uncertain. Clothianidin is highly toxic to bees on both an acute contact and oral exposure basis. A concern from the current seed treatment uses may be to beneficial insects (pollinators) that forage on crops grown from treated seed where exposure may occur through ingestion of residues in pollen and nectar as well as through guttation water produced by developing seedlings. Seed treatments are normally considered a lower exposure element to bees due to possible full ground incorporation of the seeds as well as a low drift component of the application to adjacent areas where bees may forage. However, recent incidents in Europe resulting from seed treatments where appropriate stickers were not utilized, indicate that dust-off drift can also have a significant impact on pollinators foraging in the vicinity of recently seeded fields under some environmental conditions. As such, there is uncertainty regarding the extent to which seed treatments may represent a route of exposure due to the compound's systemicand persistent nature.



### 5.2.3 

## Risk Refinement

Both high and low efficiency incorporation resulted in acute risk to freshwater invertebrates in North Carolina and Mississippi cotton, whereas cotton in California and mustard in North Dakota did not result in an exceedenceof the LOC. These results suggests that certain regions of the country are more vulnerable to run-off and exposure of the proposed application rates of clothianidin, and therefore to the potential for the toxic effects of clothianidin to freshwater invertebrates. The acute lethal toxicity to benthic invertebrates also suggests this conclusion.

### These organisms are an integral part of the freshwater trophic system and serve as both decomposerslpredators that are important for nutrient cycling and a food source for larger predators (e.g., fish). The ecological integrity in these vulnerable areas in the 

### U.S. could therefore be impacted by the use on cotton at the proposed application rate. A reduction in the cotton application rate together with maximum incorporation of the seeds into the ground could therefore limit the exposure ofclothianidin to aquatic invertebrates through run-off. Specific label language that clearly states a method of incorporation and incorporation depth would make a significant impact on other risk conclusions of the proposed new uses. Risk to estuarinelmarine invertebrates on an acute basis could be effectively mitigated by this label language, as shown by the lack of 

### LOC exceedences in the high efficiency incorporation scenario (section 5.1.1). In addition, label language that would specify more efficient incorporation methods, such as T-banded incorporation with a specified depth, would eliminate all risk to birds and mammals by burying the seeds into the ground and thereby limiting any foraging on these seeds.



## 5.3 

## Uncertainties
5.3.1 

## Exposure

## and EffectsAssessment

Accumulation of clothianidin in soils after repeated uses and the potential for transportlmigration to surface water bodies and potential risk to sensitive aquatic invertebrates (e.g., sediment-dwelling benthic organisms) Potential toxic risk to pollinators (e.g.honeybees) as the result of accumulation from seed treatments and/or foliar spray on plants/blooms from repeated uses in cotton and mustard Repeated or continuous exposure to soil invertebrates and small mammals to clothianidin accumulatedin soils after repeated uses. Data Gaps: The data gaps that were outlined in Section 2.6.1 were either required or conditionally required for clothianidin and still have to be submitted. Acceptable data from these studies will aid in reducing some of the uncertainty associated with this assessment.



## 6 

# Bibliography

Nagy, 

### K. A. 1987. Field metabolic rate and food requirement scaling in mammals andbirds. Ecological Monographs. 57:11

### 1-128.


### U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPAl6301R951002F.April 1998.


### U.S. Environmental Protection Agency. 2004a. Overview of the Ecological Risk Assessment

### Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs,Washington, 

### D.C. January 23,2004.


### U.S. Environmental Protection Agency. 2004b. Science Advisory Council for Exposure Standard Operating Procedure (SOP)#15: Amount of Seed Treated or Planted Per Day.

U.S. Environmental Protection Agency. 2005. GenericFormat and Guidance for the Level 

### I ScreeningEcological Risk Assessments Conducted in theEnvironmental Fate and Effects Division. Office of Pesticide Programs, Washington, 

### D.C. January 24, 2005.


### U.S. Environmental Protection Agency. 2004. Overview of theEcological Risk Assessment Process in the Office of PesticidePrograms. 

### http:Nwww.epa.govloppfeadl/ endanger/consultationlecorisk-overview .pdf

# Appendix 

# A. 

# REX Methodologyto CalculatedNagy Doses (EECs) 

# andRisk QuotientsforBirds andMammals

The seed treatment worksheet ofTREX calculates the avian and mammalian doses or exposure concentrations using two approaches: Nagy doses (mg a.i./kg-bw day-')and pesticide available on unit soil surface area (mg a.i. ft2). Nagy doses are used in the calculation of both acute and chronic RQsforbirds and mammals. Only acute RQs are calculated using thepesticide available on unit soil area. Nagy doses for seed treatment applications are calculated using the scaling factor approach for a 20-grambird and 15-gram mammal. Thescaling factor approach adjusts the food intake and toxicity values to account for the differences in the size of the animal assessed compared with the size of the animal used in the toxicity tests. The Agency calculates the avian and mammalian Nagy dosesusing the equation below:
Avian andMammalian Nagy Doses (mga.i./kg-bw)= (daily food intake glday "0.001 kglg 

## * maximum seed application (mg/kg-seed)/ (body weight of animal (kg)

In the second approach, the amount ofpesticide available onunit soil surface area is calculated by converting the maximum application rate from Ib acre-' to rng a.i.lft2. Theequation used for this calculation is presented below:
Availablea.i.(rnga.i.lft2)=(Maximum application rate (IbsIAcre) 

## * lo6mgkg)l(43,560squarefeetlacre

## * 2.2 IbJkg)
Calculation ofRisk Quotients (RQs)for Seed Treatment Applications

Acute risk quotients arecalculated using the adjusted LD50 value for the smallest weight class of animal (20g for birds and 15g for mammals). Acute RQs arecalculated using the two methods:
Method 1orEEC/LDSo method

Acute RQ =mg a.i./kg-' day-'/adjustedLDSo
Method 2 orEEC/LDso ft" method

Acute RQ =mg/kg-' a.i. ft2/ (adjustedLDso

## *body weight (kg)
ChronicRQs, which are not adjusted to different weight classes ofbirds ormammals, are calculated using the following equation:

# Appendix

# B. Summary

# ofEcotoxicityData
Toxicity to TerrestrialAnimals
Birds, Acute and Subacute An oral toxicity study using the technical grade of the active ingredient (TGAI)is required to establish the acute toxicity ofclothianidin to birds. Thepreferred 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 LD50is >2.000 mgkg for bobwhite quail. The NOAEL is 500mgkg with observed effects including reduced mean body weights, mortality and clinical effects (subdued birds) in the 1,000 and 2,000 mgkgtest groups. A study conducted on a non-guideline species, Japanese quail, showed that the 14-day oral LD50 is 423 mglkg. The NOAEL is 12.5mdkg bw based on clinical signs of toxicity (lethargy and ruffled appearanced) at the 25 mg/kg treatment level. Based on these results, clothianidin is categorized as ranging from practically non-toxic to moderately toxic to avian species
on an acute oral basis; the guideline (71 - 1

) is fultilled (MRID$45422417).

Avian Acute Oral Toxicity I 

### species % 

### ai 

### LDSO Toxicity 

### MRlDNo. 

### Study (Wm2) Category Author,

### Year Classification Northern bobwhite quail 96.0 >2,000 Practically non- 454224 17 Core (Colinus virginianus) toxic Johnson, 1998 Japanese Quail 97.6 423 Moderately toxic 45422418 Supplemental (Coturnix coturnix Gallagheret japonica) al., 2000

Two dietary studies using the TGAI arerequired to establish the subacutetoxicity ofclothianidin to birds. The preferred test species are mallard duck and bobwhite quail. The data that were submitted showthat the 8-day acute dietary LC50is >5,000ppm; therefore, clothianidin is categorized aspractically non-toxic to avian species on a subacute dietary basis. The 8-day NOAEC's for each speciesbased on sublethal effects (reducedbody 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 

### I 1



### Species % 

### ai 5-Day

### LC50 Toxicity 

### MRlDNo. Study (PP~)' Category Author, Year Classification Northern 96 bobwhite quail (Colinus virginianus) >5,230 Practically non- 45422419 Core toxic Johnson. 1998

Mallard duck 96 >5,040 Practically non- 45422420 Core (Anas toxic Johnson, 1998 platyrhynchos)
Birds, Chronic Avian reproduction studies using the TGAI are required for clothianidin because birds may be subject to repeated or continuous exposure to the pesticide, especiallypreceding or during the breeding season. Thepreferred test species
are mallard duck and bobwhite quail. The submitted data show that clothianidin exposure of 525 ppm adverselyaffected eggshell thickness for bobwhite quail,but did not result in chronic effects during reproduction for mallard duck; the guideline (71-4)is fulfilled (MRID#4542242 1;MRID #45422422).

Avian Reproduction I I I



### Species

Northern bobwhite quail (Colinus virginianus) % 

### ai

Mallard duck (Anasplatyrhynchos) Eggshell thickness 

### LOAEC End~oints NOAECnOAEC (PP~)
97.6 45422421 Gallagheretal., 2000 

### MRID. 

### No. Author. 

### Year
2051525

97.6 No effect on 

### ( 45422422 5251>525 

### Study 

### Classification

reproduction Core

Gallagher et al..,2000 Supplemental

Mammals, Acute and Chronic Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier laboratory mammalian studies,intended use pattern and pertinent environmental fatecharacteristics. 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 arereported below.

Mammalian Acute and Chronic Toxicity 

### Toxicity Species % 

### ai.

Rat (Rattus norvegicus) 

### Test 

### Type

Mouse (Mus musculus)


# INOAEL (M)=3 1.2mg/kg/day (500ppm0)5 96

Rat (Rattus norvegicus)

LOAEL (M)= 163.4mgkglday (2500

### vurnl5 96 Acute

96 LDso=5,000 mglkglday

Acute

Rabbit (Sylvilagus SP.) 

### Affected Endpoints

Mortality

LDSo =389-465mglkglday

2-Generation Reproduction 

### MRIDNo. Author, 

### Year
45422621 Gardner, 1997

Mortality

NOAEL (MIF) =9.811 1.5 mg/kg/day (1 501500pprn)'

LOAEL (M/F)=31.2136.8 mglkglday (5001500ppm)5

'~ecreased body weight gains and delayed sexual maturation (males only);dec F1 pups (both sexes), and increased stillbirths (F1 and F2 litters). 2Decreased sperm mobility and increased number of sperm with detatched heac 3~remature deliveries, decreased gravid uterine weights, and increased litter in( 96 ~evelo~ment~ 45422712and 

# /

-13,

1998 .eased absolute thymus weight in 45422622 Gardner, 1997

Offsprinf systemic

s (FI and F2 litters). idenceof missing lobe ofthe lung 45227 14-16 and 45422825-26, 2000and2001

Developmental NOAEL/LOAEL=25/75 mgkglda~ (82512,475ppm)4Theresults indicate that clothianidin is categorized as practically non-toxic to small mammals on an acute oral basis (LDSo =389->5,000mg/kg/day). In the 2-generation rat reproduction study, offspring systemic toxicity was detected for males and females at 500 ppm and reproductive toxicity was detected in males at 2500 ppm. TheNOAEL for offspring systemic toxicity was 150and 500pprn for males and females,respectively, and the NOAEL for reproduction was 500 ppm. In the rabbit developmental study, toxicity was observed at 75 mg/kg/day: the NOAEL was 25 mg/kg/day.
Insects, Acute Contact and Oral A honey bee acute contact study using the TGAI is required for clothianidin because its foliar application treatment use will result in honey bee exposure. The acute contact LD50,using the honey bee. Apis mellifera, is an acute contact, single-dose laboratory study designed to estimatethe quantity oftoxicant required to cause 50%mortality in
a test population of bees. The acute contact LD50for clothianidin is 0.0439 yg a.i./bee and it is, therefore, classified
as highly toxic to bees on a contact exposure basis < 2 ~(g a.i./bee, based on toxicity categories in Atkins (198I)]. Theguideline (141-1)is fulfilled (MRIDNo. 45422426).

per fetus. 4 pprn conversionbased on: 1 mg/kg/day = 20pprn in adult rats, I0pprn in younger rats, 7 pprn in mice and 33pprn in rabbits. (Nelson, 1975) 5pprn value determined from study. 

### Toxicity Affected Endpoints

Five acute oral toxicity studies are available for clothianidin and its metabolites: however, they are categorized as supplemental because the submission of honey bee acute oral toxicity studies is not a guideline requirement. The Office of Pesticide Programs (OPP) does not have a categorization scheme for acute oral toxicity to honey bees. However, based on the ICBB (1985) acute oral toxicity categorization scheme, clothianidin would be considered highly toxic to the honey bee by the oral route. With the exception of TZNG, the clothianidin metabolites TMG. MNG, and TZMU would be virtually non-toxicto honey bees. TZNG would be moderately toxic. 

### MRIDNo. 

### Author, Year Test Type 

### Species % 

### a.i.

( Honey bee Acute Contact Toxicity - Clothianidin 

# I Nontarget Insect Acute Contact and Oral Toxicity

SpecieslStudy Duration

Honeybee (Apis mellifera) 48 hour LD50 (~g ailbee) %ai

highly toxic

Honey bee Acute Oral Toxicity - Clothianidin 96

Honey bee (Apismellifera) 48 hour



# I Honey bee Acute Oral Toxicity - ClothianidinMetabolite - MNG 

# I Toxicity Category

0.0439 45422426 Weyman, 1998

Honey bee Acute Oral Toxicity - Clothianidin Metabolite -TMG Core

96

Honey bee (Apismellifera) 48 hour MRIDNo. Author,Year

Honeybee Study Classification

0.0037

96 not applicable

2152

99.2 >I53 not applicable 45422426 Weyman, 1998

not applicable Supplemental

45422428 45422427 Wilkins, 2000

Supplemental SupplementalInsects, Mortality, Reproduction, and Feeding Capacity Two studies were submitted to show acute effects of corn (MRID45422520) and summer rape (MRID 45422521) seeds treated with TI 435 FS600 (formulated product) on carabid beetles (Poecilus cupreus) under extended laboratory test conditions. The goal of these studies was to evaluate whether or not exposing carabid beetles to clothianidin treated corn or rape seeds increased 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 Ib ai/A showed abnormalities (undescribed signs of intoxication). Rape seed treated with clothianidin at an application rate of 0.095 Ib ai/A caused behavioral impacts (intoxication) to 63 % of adult carabid beetles in the treatment group. The feedingrate 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.

Three studies (MRTDNos. 45422524,45422522, & 45422523) were submitted to show effectsof clothianidin onthe life cycle of rove beetles (Aleochara bilineata) under extended laboratory conditions. The first study (MRTD No. 45422524) was designed to evaluatethe effects clothianidin would have on the beneficial ground beetles exposed to the pesticide in treated soil. Study endpoints were adult mortality and reproduction (total number of progeny produced). In this study, there were no significant differences observed between the control and clothianidin treatment groups for adult mortality. Reproductiveperformance (as indicated by decreased number of progeny) was affected in the two highest clothianidin treatment groups (200 and 250 pg a.i./kg soil). The goal of final two (2) rove beetle studies was to evaluate whether or not exposure of rove beetles to corn seeds (MRID No. 45422522) treated at a rate of 0.55 Ib ai/A and to rape seeds (MRID No. 45422523) treated at a rate of 0.095 lb ai/A (10 g a.i./kg TI 435 FS 600) would result in significantly increased mortality of parent beetles and whether or not the offspring production rate would be adversely affected. The beetles exposed to the treated corn seed experienced a significant increase in mortality (55%) but no significant reproductive difference when compared to the controls. The reproductive performance of the rove beetles was determined by counting the number of rove beetles which emerged from the host pupae between days 39 and 77 after treatment. Rovebeetles exposed to the treated rape seed experienced an increase in mortality and a reduced parasitization capacity. The number of offspring that emerged (reproductive performance) in the rape seed treated test groups was not significantly lower than the control group. These studies were scientifically sound and classified as Supplemental.

SpecieslStudy Duration (Apis mellifera) 48 hour

Insects, Residual Contact A honey bee toxicity of residues on foliage study is required on an end-use product for any pesticide intended for outdoor application when the proposed use pattern indicates that honey bees may be exposed to the pesticide and when the formulation contains one or more active ingredients having an acutecontact honey bee LD50 which falls in the moderately toxic or highly toxic range. The purpose of this guideline study is to develop data on the residual toxicity to honey bees. Bee mortality determinations are made from bees exposed to treated foliage harvested at various time periods after treatment. Clothianidin, as indicated in the acute toxicity test (MIUD 45422426), is highly toxic to honey bees on a contact basis. Pesticides toxic to honey bees require bee precautionary labeling on Toxicity Category %ai

Honey bee Acute Oral Toxicity - ClothianidinMetabolite - TZMU MRIDNo. Author,Year Wilkins, 2000 LD50 (pg~ihe) Study Classification

Honey bee (Apismellifera) 48 hour Supplemental 98.8 not applicable

Honey bee Acute Oral Toxicity- ClothianidinMetabolite - TZNC >I13 45422429 Wilkins,2000

Honeybee (Apistnellifera) 48 hour 98.6 3.95 not applicable 45422430 Wilkins, 2000 Supplementalall end-use formulations and registrants are required to submit data in accordance with Guideline 141-2

### - Honey Bee Toxicity of Residues onFoliage. A scientifically-sound study was performed.

Alfalfa foliage was sprayed with Clothianidin. as V-10066, at application rates of 30, 60, and YO g a.i.1acre. Honey bees, three replicateslrate, were exposed in the lab to the weathered foliage at varying times until the mortality of bees exposed to residues was lower than 25%. Sublethal observations were also made. The RT,, for V-10066 at 30, 60, and 90 g a.i./acre were 111.68, 179.5 1,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 indicatethat clothianidin, a5 V10066, should not be applied to blooming pollen-shedding or nectar-producing parts of plants. Non-target Insects - Toxicity of Residues on Foliage I I MRID

### No.

Honey Bee 30 111.68 45490702 Supplemental (Apismellifera) (0.07lb ai/A) (4.7days) Mayer. 2000 Honey Bee 60 179.51 45490702 Supplemental (Apismellifera) (0.13Ib ai/A) (7.5 days) Mayer, 2000 Honey Bee 90 512.39 45490702 Supplemental (Apis mellifera) 0.21 (Ib ai/A) (21.3days) Mayer, 2000 

## ' RTZ5 isthe residual timerequiredto reduce the activity ofthe test materialand bring bee mortality down to 25% in cage test exposures to field-weatheredspray deposits (MayerandJohansen, 1990). The time period determinedby this toxicity value is consideredtobe time that the test material is expected to remain toxic tobees in the field from the residual exposure ofthe test materialon vegetationat an expressed rate of application(Ib ai/A).
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 application rates (8.62 Ib ai/1000 Ib seed or 0.038 Ib ai/acre; 10.4 Ib ai/1000 Ib seed or 0.046Ib ai/acre; 6 Ib ai/1000 Ib seed or 0.04 Ib ailacre; and 1Ib ail100 Ib seed or 0.025 Ib ai/acre). Residue levels in the honey bees that foraged on the plants grown from the treated seeds were also determined. These studies were considered scientifically sound; however, they do not fulfill the requirements for a pollinator field test (OPPs Guideline 141-5) because the protocol was not approved by EPA. They are classified as Supplemental. An approved protocol would have required that the studies be conducted in the United States, longer duration of honey bee activity observations. and the use of replications in the treatments and controls for statistical analyses. Field exposure to the test substance and the bee observation period were too brief (< 30 daysj lo fully evaluate the impact the exposure levels of clothianidin would have had on the bee colonies tested. The complete life cycle for an individual worker bee during the time period tested would be approximately 63 days.

These field studies evaluated the effects to small honey bee colonies hived on clothianidin rape seed treated and untreated (control) plots. Colonies were placed, on the treated and untreated plots during the rape bloom stage approximately two months after the rape crops were planted. Bees were monitored for short periods of time to determine if they were being adversely affected by the clothianidin exposure as a result of the systemic activity demonstrated by clothianidin. Residues of clothianidin in the nectar from rape flowers ranged from I .O to 7.2 pg ai/kg. Nectar sampled from beehives ranged from 0.9 to 3.7pg adkg and nectar sampled from forage bees honey stomachs contained 8.6 pg ai/kg clothianidin. Residues of clothianidin were also found in forage bees (1.4 pg ai/kg), rape flowers (3.3 - 4.1 pg ailkg). pollen taken from foraging bees (1.7 - 2.5 yg ai/kg), and pollen from beehives (1.6 - 3.0 pg ailkg). These residues were a result of the clothianidin seed treatments performed approximately 60 days prior to sampling the commodities. Two (2) studies (MFUD 45422436 & 45422437) also tested for the clothianidin metabolites, TZMU and TZNG, but residues of these metabolites were not found in the nectar and pollen samples analyzed. With the exception of one study (MRID 45422435): none of the studies reported mortality or adverse effects to the foraging activity of the bees. However, the residue levels in the nectar taken from the bees, 8.6 pg ailkg, exceeds the honey bee acute oral LDSo of 3.7pg ai/kg (MRID 45422426). One honey bee field study (MRID # 45422435) showed that mortality, pollen foraging activity, and honey yield werenegatively affected by residues of clothianidin; however, residues were not quantified in this study.
Non-targetInsectReldStudies MRID# Study Study Classification Location & Plant Date of Treated Seed Chemical Sample Commodity Application Date(s) Sampled Rate Clothianidin ResiduesFound 

### (Pg

45422431 Supplemental BorlundaSkelinge, Sweden Clothianidin lSt week of forage bees July '98 8.6g a.i./kg seed
or 1" week of nectar in bces 8.62 Ib ail1000 Ib July '98 seed
or 7/3/98 nectar from 0.038 Ib ailacre and rape flowers 7/2/98 1.4

8.6

1.2 and

1" week of rape flowers July '98 45422432 Supplemental Elm Farm., United Kingdom Clothianidin 6122-6124198 rape flowers 3.3

none detected 10.4Ib ai/1000Ib seed
or 0.046 Ib ailacre 6122-6124198 foragebees

45422433 Supplemental Conches in Northern France Clothianidin 6115-6/18/98 pollen taken from forage bees 10.4Ib ail1000Ib seed
or 0.046Ih ailacre 45422435 Supplemental Ontario, Canada Clothianidin 6126-7/20/00 pollen from bee hives 3.0 (61days after application) 6 Ib ai/1,000Ib seed
or 0.04 Ib ai/A 1.6 (68days after application)

nectar from bee hives 3.7 (61 days after application)
0.9 

### * (68 days after application) Minnesota, US 5116/00 6128-7/28/00 pollen from bee hives 2.3 (50days after application)
2.8 (57days after application)Non-targetInsectField Studies
MRID# Study Study Chemical ClassBcation Location& Application PlantDate Rate ofTreated Seed

45422436 Supplemental Monheim. Clothianidin Germany 1056g a.i.1100 5/2/00 kg seed or I Ib ail100Ib seed
or 0.025Ib ai/A 45422437 Supplemental Burscheid. Clothianidin Germany 1056ga.i.llOO 4/28/00 kg seed or 1 Ib ail100Ib seed or 0.025lb ai/A Sample Commodity Clothianidin Dates) Sampled Residues Found (agailkg)

nectar from 1.1 bee hives (50days after application)
1.0 (57days after application
7/6/00 nectarfrom 2.8 and rape flowers and 7/7/00 3.0

6130100 nectar from 5.4 and rape flowers and 7/6/00 I .0
combs pollen from 1.9to 2.5 sampled combslforage 7112/00; bees foragebees sampled on 712 and 7118/00 

# 1 * <Level of Quantitication(LOQ)=10pgkg and Level of Detection (LOD)=0.3 pgkp 

# I

A seventh honey bee field study (MRID No. 45422440), reviewed under guideline 141-5, evaluated the effects of clothianidin treated pollen on the development of small honey bee colonies and on the behavior and mortality of honey bees. Three treatment levels and two controls were tested. One small beehive (about 500bees) per treatment and control was tented on oat plots in cages and fed treated maize pollen. Pollen treated with clothianidin at a measured concentration level up to 19.7 pg ailkg produced no significant adverse effects to the parameters measured in this study based upon the visual inspection of the data. The parameters measured included mortality, foraging activity (including honey and pollen collection). comb production, honey storage behavior, population growth (including egg, larvae, pupae, and adult growth stages) and behavioral anomalies. Since there was only one replicate hive per treatment level, a statistical analysis could not be made of the data provided. MIUD No. 45422440 was determined to be scientifically sound and classified as Supplemental.

An eight honey bee field study (MRID46907801/46907802) evaluated the long-term effects of clothianidin treated canola seed on whole hive parameters. This study was classified as scientifically sound and satisfied the guideline requirements for a field toxicity test with honeybees (OPPGdln. No. 141-5;OPPTS 850.3040). Overall. there was no difference between colonies from clothianidin-treated and control fields. Although sporadic treatment or site differences were found on various dates, essentially no differences in worker or drone mortality, worker longevity,
or brood development occurred during the study. Colonies in treated fields had similar weight gains and honeyyields as those in control fields. Qualitative assessments, made the following spring by experienced bee researchers, confirmed that colonies from clothianidin-treated fields were as strong and healthy as those from control fields. It
was concluded that honey bees that forage on clothianidin seed-treated canola will be exposed to clothianidin residues in pollen, nectar, and honey; however. exposure concentrations are below those required to elicit acute and sublethal effects. This study has recently been re-reviewed and found to contain deficiencies that limit its ability to determine the effects of clothianidin treated seed on honeybees. It is classified Supplemental due to cross contamination of the control hives that foraged in treated fields. Spider, Mortality and Feeding Capacity Two extended laboratory studies (MRID Nos. 45422518 & 454225 19) evaluated the effects of clothianidin treated seed on the wolf spider, Pardosa spp. (Araneae, Lycosidae). The goal of these studies was to evaluate whether or not exposing wolf spiders to treated corn and rape seeds increased mortality or decreased feeding rate compared to the controls. The seed treatment rate for the corn seeds was 48.8 g a.i./Unit(1 Unit =50,000 seed)with 2 corn seeds per 1170 cm2test box equivalent to 0.15 Ib ai/A. The seed treatment rate for the rape seeds was 10 g a.i./kg TI 435 FS 600 with 4 rape seeds per 178 cm2 test box equivalent to 0.06 lb ai/A. The studies' results indicated that the wolf spider mortality and feeding capacity in the clothianidin treatments were not significantly different from the controls. These studies were scientifically sound and classified as Supplemental.
Earthworm, Acute and Chronic Five acutelchronic earthworm studies were reviewed for clothianidin and its metabolite/transformation products. These studies were conducted in compliance with the Organization for Economic Cooperation and Development (OECD) guidelines for testing of chemicals and were reviewed, by EFED, under EPA Ecological Effects Test Guidelines (U.S. EPA Ecological Effects Test Guidelines, April, 1996). EFED does not have a toxicity categorization for earthworms. The clothianidin earthworm LCSo (conc. in soil) was determined to be 15.5mglkg (MRID No. 45422511) with the metabolite, MNG, and transformation product, TZNG, being less toxic to earthworms than the parent compound. EPA does not presently require reproductive or population toxicity testing with earthworms for pesticide registration; however, two studies indicate that clothianidin exhibits no apparent effect to earthworm reproduction at application rates equal to or greater than 0.054 Ib ai/A (MRID 45422525) or

opulation densityhiomass at application rates equal to or greater than 0.08 Ib ai/A (MRID 45422526). 

# I EarthwormAcute and ChronicToxicity
LC501 NOAEC/ EC50 LOAEC MRID# Study Endpoints Authornear Classification % (mgflrgindry (m%kg in dry Spedes/Study ai sdl orIb soil orIb &A) Duration ai/A) Eisenia foetida 96 15.5mgkg < 10.0 mglkg mortality 45422511 Acceptable (nominal) (nominal) Weyman. 1998 14days
Eisenia fetida 48 >0.054Ib 2 0.054Ib ai/A1 no significant 45422525 Supplemental 

### ail^' (nominal) treatment- Meisner, 2000 56days (nominal) related effects on mortality, body weight,
or # offspring1 surviving adult
Lumbricus 47.8 >0.08Ib ai/A2 2 0.08 Ib ai/~' no significant 45422526 Supplemental terrestris, (measured) (measured) treatment- Heimbach, 2000 L.rubellus, related effect L. castaneus, on number and hiomass of Apporrectodea earthworms caliginosa,EarthwormAcuteand Chronic Toxicity 

### LC501 NOAEU ECSO LOAEC MRID# 

### Study Endpoints Author~Year Cldcation % (rng/kgindry (mg/kg

### indry SpeciedStudy ai soilorIb soilorIb ailA) Duration aVA) Allolohophora chlorotica

1year Clothianidin Metabolite - MNG
Eisenia fetida 99.2 > 1,000 320mglkg reduction in 45422512 Acceptable mgkg (nominal) hody weights Noack, 2000 14 days (nominal)
Clothianidin Transformation Product - TZNG
Eiseniafetida 99 982 mgkg 125 mgkg mortality 454225 13 Acceptable (nominal) (nominal) Noack, 2000 14days 63 mgkg reduction in (nominal) body weight 

## ' Equivalent to >500,000clothianidin dressed corn seedsha 'Equivalent to >91.4 g a.i./ha


## Toxicityto 

## Aquatic Organisms

Freshwater Fish, Acute Two freshwater fish toxicity studies using the TGAI are required to establish the acute toxicity of clothianidin to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish (a warmwater fish). The acute studies that were submitted that tested the parent compound showed that clothianidin is practically non-toxic to freshwater fish (LCSo >105.8 -1 17 ppm). Studies on degradates (TMG, MNG, and TZNG) indicated a similar practically non-toxic profile (LCs0 >lo5 ppm). EFED will use the worst case value (LC5,) >105.8 ppm) for evaluating acute toxic exposure to freshwater Ash. The guideline (72-1) is fulfilled (MRID 45422407; MRID 45422406).

FreshwaterFishAcute Toxicity Species % ai %-hour Toxicity MRIDNo. Study LC50(PP~) Category AuthorNear Classification

(nominal) Bluegill sunfish 97.6 >I 17 Practicallynon- 45422407 Core (Lepomis macrochirus) toxic Palmer et al



## . 2000 Rainbow trout 96 >105.8 Practically non- 45422406 Supplemental (Oncorhynchusmykiss) toxic Wilhelmyet al., 1998 Rainbow trout 95.1 >I 10 Practically non- 35422408 Supplemental (Oncorhynchusmykiss) TMG toxic Dorgerloh, 2000 Rainbow trout 99.0 >I05 Practically non- 45422409 SupplementalFreshwater FishAcuteToxicity Species % ai %-hour Toxicity MRID No. Study LC50 (ppm) Category Author/Year Classiffcation

(nominal) (Oncorhynchusmykiss) MNG toxic Dorgerloh, 2000
Rainbow trout 99.0 >I16 Practically non- 45422410 Supplemental (Oncorhynchusmykiss) TZNG toxic Dorgerloh, 2000

Freshwater Fish, Chronic A freshwater fish early life-stage 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 aremet: (I)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 744days aerobic soil metabolism).

A chronic early life stage study conducted on the fathead minnow showed that exposure of 20 ppm has the potential to affect length and dry weight of freshwater fish. TheNOAEC of 9.7ppm will be used forrisk assessment purposes. The guideline (72-4) is satisfied (MRID#45422413).

Freshwater FishEarly Life-StageToxicity UnderFlow-Through Conditions Species % ai NOAEULOAEC Endpoints MRID No. Study (PP~) Affected Authornear Classification Fathead Minnow 97.6 9.7/20 Length and dry 45422413 Supplemental (Pimephales promelas) weight Drottaret al.,2000

Freshwater Invertebrate Acute Toxicity for Clothianidin Species %ai 48-hourECSn Toxicity MRIDNo. Study (PP~) CatetZOrY AuthorIYear Classification

Waterflea 99 (Daphnia magna) >I19 Practically non- 45422338 Core toxic Palmer. 2000

Midge 97.6 0.022* Very highlytoxic 45422414 Supplemental (Chironomus Mattock,2001

riparius)
Waterflea 99.0TZNG 64 Slightlytoxic 45422401 Core (Daphnia Hendel, 2000 magna)
Waterflea 99.0MNG >100.8 Practically non- 45422340 Core (Daphnia toxic Hendel, 2000 magna)
Waterflea 95.1TMG >115.2 Practical1ynon- 45422339 Supplemental (Daphnia toxic Hendel, 2000 magna) Midge LC5o = I 1ppb (Chironomus Very highly >99 NOAEC 1.lppb toxic 468269-02 Supplemental riparius) Putt,A.E. 2006

### * The ECso value forexposure to Clothianidin TI-435was the most sensitive;ECSo values forTZMU,MU, and TZNG were >I02ppm, $33.6ppm, and 0.386ppm, respectively.

Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of clothianidin to aquatic invertebrates. Thepreferred test species is Daphnia magna. The data that was submitted that tested the parent compound showedthat clothianidin is practically non-toxic to Daphnia magna with an acute 48-hour ECS0 value of >I 19ppm, but that it is very highly toxic to Chironomusriparius with an acute 48-hour ECSo value of 0.022 ppm. EFED will use the worst case value (ECSo= 0.022ppm) for evaluating acute toxic exposure to freshwater invertebrates. Additional data (48-hourECSo)on degradates (TZNG, MNG, and TMG) indicated a practically nontoxic to slightly toxic profile (ECso=64.0 to >I 15.2 pprn). Another study (MRID46826902) assessed the toxicity to the midge (Chironomus riparius) during a 10-Day sediment exposure. This study revealed anLCs0of 1I ppb and
a NOAEC of 1.1ppb based onpore water concentrations. The guideline requirements (72-2)for acute invertebrate toxicity are fulfilled (MRID45422338; MIUD 45422414).

Freshwater Invertebrate, Chronic A freshwater aquatic invertebrate life-cycle test using the TGAI is required for clothianidin because the end-use product may be transported to water fromthe intended use site, and the following conditions are met: (1) the presence of clothianidin in water is likely to be continuous or recurrent and (2) aquatic acute LCsoor ECsO values are less than 1 pprn (i.e., 0.022ppm), and (3)physicochemical properties indicate that clothianidin is persistent in the aquatic environment (e.g., half-life of 744days aerobic soil metabolism).

Thepreferred test is a 21-day life cycle on Daphnia magna. The data that were submitted showthat clothianidin has the potential for chronic toxicity to daphnids and possibly other freshwater invertebrates. Exposure to 0.12pprn can result in reproductive effects, including the reduced number ofjuveniles produced per adult. TheNOAEC of 0.042 pprn will be used in assessing risk. The guideline (72-4) is fulfilled (MIUD 454224 12).

Freshwater Aquatic Invertebrate ChronicToxicity sped& kai 21-day MATC' Endpoints MRIDNo. Study StaticRenewal NOAEXXOAEC (PPm) Affected Authornear Classification (PP~) Waterflea 96 0.032/0.12 ND Reproduction 45422412 Supplemental (Daphnia Noack et al., magna) Static 1998 Renewal

Freshwater Field Studies No data submitted.
Estuarine and Marine Fish, Acute Thepreferred test species is sheepshead minnow. The data submitted showed that the LCs0= 93.6ppm; therefore, clothianidin is categorized as slightly toxic to estuarinelmarine fish on an acutebasis. The guideline (72-3)is fulfilled (MRID45422411).

Estuarine/Marine FishAcute Toxicity 96-hour Toxicity MRIDNo. Study Species/Static % ai LC50(PP~) Category Authornear Classification (nominal) Sheepsheadminnow 97.6 >93.6 Slightlytoxic 45422411 SupplementalEstuarinelMarineFishAcuteToxicity %-hour Toxicity MRIDNo. Study Spedeslstatic % ai LC50 (PP~) Category AuthorrYear Classification (nominal) (Cyprinodonvariegatus) Scheerbaum, 1999

Estuarine and Marine Fish, Chronic No data submitted.

Estuarine and Marine Invertebrates,Acute Acute toxicity testing with estuarinelrnarine invertebrates using the TGAI is required for clothianidin because the end-use product is expectedto reach this environment dueto its potential use oncrops with significant acreage in coastal counties. Thepreferred test species are mysid shrimp and eastern oyster. Thedata showed that clothianidin significantly reduced survival of mysid shrimp at 0.051ppm, categorizing the compound as very highly toxic. Clothianidin was categorized as practically non-toxic to Eastern oyster because adverse effects did not occur forthis species up to concentrations of 129.1 ppm. EFED will use the worst casevalue, LC50=0.05 1ppm, for evaluating acute toxic exposureto estuarinelmarine invertebrates. A 10-day whole sediment toxicity test with Leptocheirus plurnulosus using spiked sediment was submittedto the Agency. This study is classified as supplemental,and showsthat clothianidinis very highly toxic to benthic estuarinelmarine invertebrates with anLC50 of 20.4 pg/L and a NOAEC of 1 1.6 pg/L based onpore water concentrations. The datarequirements (72-3b) are fulfilled (MRID 45422404; MRID45422403).

EstuarineMarineInvertebrateAcute Toxicity Species/Staticor %ai. %-hour ToxicityCategory MRIDNo. Study

Flow-through LC9 (PP~) Author/Year ClassiP~cation

Eastern oyster 97.6 ECx,>I29.1 Practically non- 45422404 Core (Crassostrea virginica) toxic Scheerbaum, 1999 Mysid 97.6 LCSo=0.05 1 Very highly toxic 45422403 Core (Americarnysisbahia) Drottaret a].,2000 LC50 =20.4 Leptocheirusplurnulosus 99.4 ppb Veryhighlytoxic 47 1994-01 Supplemental NOAEC = Thomas et al., 2007 11.6ppb
Estuarine and Marine Invertebrate, Chronic An estuarinelrnarine invertebrate life-cycle toxicity test using the TGAI is required for clothianidin because the enduse product is expected to transport to an estuarinelrnarine environment from the intended use site, and the following conditions are met: (I)the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity, (2) an aquatic acuteLCSo orECso is less than 1ppm (e.g.,mysid LC50 

### =0.051ppm), and (3)studiesof other organisms indicate that the reproductivephysiology of fish and/or invertebrates may be affected,physicochemical properties indicate cumulativeeffects, orthe pesticide is persistent in water (e.g., half-life of 744days aerobic soil metabolism).

Thepreferred test species is mysid shrimp. The data submitted indicate that clothianidin reduced the number of young per reproductive day at 9.7 ppb. TheNOAEC of 5.1 ppb will beused in assessingrisk. The guidelines (72-4c) have been fulfilled (MRID 45422405).

EstuarinelMarineInvertebrateLie-CycleToxicity spedes % ai 39-day Endpoints MRIDNo. StudyEstuarine/MarineInvertebrateLifecycle Toxicity NOAECnOAEC Affected Authornear Classification (PP~) Mysid 97.6 5.119.7 Reproduction 45422405 Core (Mysidopisbahia) Drottaret al.. 2000

Estuarine and Marine Field Studies No data submitted. Aquatic Plants Several aquatic plant toxicity studies using the TGAIarerequired to establish thetoxicity of clothianidin to nontarget aquaticplants. Therecommendation is for testing onfive species: freshwater green alga (Selenastrum capricornutum), duckweed (Lemna gibba), marine diatom (Skeletonema costatum),blue-green algae (Anabaena flos-aquae), and a freshwater diatom. Studies submitted for two of the five recommended species showed that exposure to clothianidin at levels greater than orequal to 3.5 ppm reduced biomass of aquatic non-vascular plants and increased the incidenceof necrotic fronds in aquatic vascular plants. Studiesondegradates (TMG,MNG and TZNG) showed reductions in green algal cell density when exposed to levels >I .46ppm. TheECSo of 64ppm will be used for evaluating acute toxic exposure to non-target aquaticplants. Theguidelinerequirements (122-2 and 123-2)are fulfilled (MRID45422503;MRID 45422504) for two of the five required species. EFED needs 3 more Coreclothianidin studies for the nonvascular surrogate species, marine diatom (Skeletonema costatum), blue-green algae (Anabaenujlosaquae), and a freshwater diatom. Non-target Aquatic Plant Toxicity I 1 

### Species [StudyType1

Green Algae 6413.5 (Selenastrum capricornutum)

Duckweed (Lernnagibba) [Tier21

Green Algae 95.1 (Selenastrum TMG capricomutum) [Tier21 % ai.

97.6 EC-AEC (PP~) Endpoints MRIDNo. Author, Year

Green Algae (Selenastrum capricornutum) [Tier 11 Biomass 45422504 Sutherlandet al., 2000 Necrotic fronds

99.0 MNG Cell density 45422505 Dorgerloh. 2000 45422503 Palmerel al.,2000

>100.6/100.6 Study Classification

None Core

45422506 Dorgerloh.2000 Core

Core

Core

Core

Terrestrial Plants Terrestrial Tier I1studies arerequired for all low dosepesticides (thosewith the maximum use rate of 0.5 Ibs a.i./A
or less) and for anypesticide showing a negative response equal to or greater than 25% in Tier I studies. Two Tier I terrestrial plant toxicity studies were conducted to establish the toxicity of clothianidinto non-target terrestrial plants. Therecommendations for seedling emergence and vegetative vigor studies are for testing of (1) six species Green Algae (Selenastmm capricomutum) [Tier 11 Cell density 45422507 Dorgerloh,2000 99.0 TZNG >103/<103of at least four dicotyledonous families, one species of which is soybean (Glycine max) and the second of which is a root crop, and (2) four species of at least two monocotyledonous families, one of which is corn (Zea mays). The studies that were submitted tested formulated products of clothianidin (49.3%TI-435 50%WDG). Theresults of these studies showed that exposure elicited no effect (that is, 2 25%) onnon-target terrestrial plants, soTier I1tests
were not necessary. Theguidelines (122-laand 122-1 b) are fulfilled (MRID45422501;MRID45422502).

Non-target Terrestrial Plant Toxicity I

- - - 

# m: Soybean (Glycine max), Pintobean (Phaseolusvulgaris), Radish (Raphanus sativus), Cabbage (Brassicaoleracea), Lettuce (Lactuca sativa),Tomato (Lycopersiconesculentum) 49.3 TI-435 50% WDG

Monocots: Corn (Zeamays). Wheat (Triticumaesti\ium). Ryegrass(Loliumperenne), Onion (Alliumcepa) [TierISeedling Emergence]

Dicots: Soybean (Glycine max), Pinto bean (Phaseolusvulgaris), Radish (Raphanussativus), Cabbage (Brassicaoleracea), Lettuce (Lactuca sativa),Tomato (Lycopersicon esculentum)

Monocots:Corn (Zeamays), Wheat (Triticumaestivum). Ryegrass (Loliumperenne), Onion (Allium cepa) Application Rate (ib &A)
0.2 Endpoints MIUDNo. APfected Author,

### Year

- - 45422501
effect on 2000 seedling emergence

45422502 sic 

# /
Brignolzt al., reduction in 

### I Study I Classification

Core

Core

# Appendix C. The Risk Quotient Method and Levels of Concern

The Risk QuotientMethod is the meansby which theEnvironmental Fate and EffectsDivision 

### (EFED) integratesthe results of exposure and ecotoxicity data. In this method, both acute and chronicrisk quotients(RQs)are calculatedby dividing exposure estimatesby the most sensitive ecotoxicityvalues or toxicity endpoints derived from the studies. CalculatedRQs arethen comparedto OPP's levelsof concern (LOCs). The LOCs arethe criteriaused by OPPto indicatepotential riskto non-target organisms and the need to considerregulatory action.EFED has definedLOCs for acute risk, potential restricted use, and for endangered species. Risk presumptions, alongwith the correspondingRQs and LOCs are summarized in the table below.

Birds
Acute Risk EEC/LCTO or LD5dsqftor LDSrjday 0.5
Acute Restricted Use EEC/LC50 or LD5dsqftor LDTdday (orLDTo <50 0.2 mg/kg) Acute Endangered Species EEC/I,CSoor LDSo/sqft or LD5dday 0.1 Chronic Risk EEC/NOAEC 1
Mammals
Acute Risk EEC/LCSo 

### orLD,dsqft or LD5rjday 0.5
Acute RestrictedUse EEC/LC50 or LD50/sqft or LDSdday(orLDso

### <50 0.2 mg/kg) Acute Endangered Species EEC/LCSo or LDSdsqftor LD5u/day 0.1 ChronicRisk EEC/NOAEC I Aquatic Animals
Acute Risk EEC/LCSo or ECso 0.5 Acute RestrictedUse EEC/LCSo or ECSO 0.1 Acute Endangered Species EEC/LCSO or ECS~ 0.05 ChronicRisk EEC/NOAEC 1 Terrestrialand Semi-Aquatic Plants
Acute Risk EEC/EC25 1 Acute Endangered Species EEC/EC05 or NOAEC I Aquatic Plants Acute Risk EEC/ECSO 

# 0 1

# Appendix 

# D:Equilibrium Partitioning and Concentrationin the Sediment

In general, pyrethroid insecticides are lipophilic compounds that can adsorb readily to particulate and sediment, thus possibly limiting its exposure to aquatic life in the water column but increasing toxic exposure in the benthos. Sediment can act as a reservoir for lipophilic persistent compounds. The sediment and particulate likely adsorb a high percentage ofpyrethrin, as indicatedby its high KO,. Therefore, coupled with cypermethrin's expected persistence in anaerobic environments, sedimentbound cypermethrin couldpresent
a toxicity risk for benthic aquatic life and aquatic ecosystems in general. Exposure to this sediment can result in a direct impact to aquatic life through respiration, ingestion, dermal contact, as well as indirect impact through alterationsof the food chain. Pesticide compounds that bind readily to particulate and organic carbon in the water column can eventually settle onto the benthos. This increase in particulatebound pesticides can result in 

### an accumulation of compounds in or on the sediment that may have the potential for toxic impact to benthic and epibenthic aquatic organisms (e-g., early life stage of many invertebrates and fish, as well as crabs and shrimp). However, evaluating the risk to aquatic life fiom this exposure becomes problematic given the lack of adequate sediment toxicity and exposuredata.
Therefore, in order to assess this potential for pesticide risk to aquatic benthic systems, EFED has adopted the method used by the USEPA Office of Water (OW) that relies on equilibrium partitioning (EqP) of chemicals. Th EqP theory is based on the hydrophobicity and concentrations of the chemical normalized to organic carbon (OC) in sediment (De Toro et 

### al., 

### 1991) and holds that a nonionic chemical in sediment partitions between sediment organic carbon, interstitial (pore) water and benthic organisms. At equilibrium, if the concentration in any phase is known, then the concentration in the other phases can be predicted.A key componentto this theory is the chemicals organic carbon coefficient (Koc), which is constant for every chemical andrepresentstheratio of the chemical concentrationin water to the concentration in organic carbon. The document, 

## " Technical Basis for the Derivation of Equilibrium Partitioning Sediment Guidelines (ESG) for the Protection of Benthic Organisms: Nonionic Organics" (USEPA, 2000a), demonstrates that biological responses of benthic organisms to nonionic organic chemicals in sediments are different when the sediment concentrations are expressed on a dry weight basis, but similar when expressed on a ug chemicallg organic carbon basis (uglg,,). Similar responses were also observed across sediments when interstitial water concentrations were used to normalize biological availability. The TechnicalBasis Document further demonstratesthat ifthe toxic effect concentration in water is known (e.g.,

### LC,,),the effect concentrationin sediment on a uglg,,basis can be predictedby multiplying the effect concentrationin water by the chemical Koc. (LC50ug/L x KocLlkgoc x 1

### kgoc/1000goc =

### LC50 pg/goc)
Since EFED uses a deterministic method for its screening level risk assessment, the calculation of risk quotient values (RQ) is 

### important for assessing possible risk. The RQ

### values are calculated by taking the ratio of the estimated exposure concentrations (EEC) to the toxicity effect value (e.g., LC,,, NOAEC). The EEC values are model generated (e.g., PRZW EXAMS) and reflect peer evaluated and approved scenarios for assessing pesticide exposure to an aquatic environment. However, the PRZNII EXAMS output produces water column EEC values, as well as sediment and porewater EEC values. Therefore, in order to assess possible toxic pesticide exposure to aquatic organisms from sediments, EFED uses the 

### PRZMI EXAMS model, which incorporates the principles of the equilibrium partitioning theory, in order to generate EECs from sediment and pore water. 

### By relying on sediment andlor porewater output values, EFED uses two methods to calculate 

### RQ values for sedimentsby using porewater exposure values and bulk sediment values.

Risk calculations that rely on pore water concentrations can be calculated by dividing the PRZMI EXAMS output value for pore water by the dissolved concentrations in the water column that cause toxicity inbioassays (e.g.,LC50).EEC pore water ug/L 

### 1 LC50 ugL

If sediment effects data are available (LC50 uglkg,), 

### RQs can be produced by using the PRZMI EXAMS sediment output value for sediment.

EEC sedimentuglugoc 1LC50ugkgoc

The following three principle observations underlie the equilibrium partitioning (EqP) approach: The concentrations of nonionic organic chemicals in sediments (expressed on an organic carbon basis) and in interstitial waters correlate with observed biological effects on sediment-dwelling organisms across arange of sediments. Partitioning models can relate sediment concentrations for nonionic organic chemicals on an organic carbon basis to freely-dissolved concentrations in interstitial water. The distribution of sensitivities of benthic organisms is similar to that of water column species.

# Appendix

# E:Aquatic Exposure Model Input and Output

MASTER INPUT COMPILATION (Project File) for EXPRESS 

### PRZM-EXAMS Modeling Interface (includes scenarios for several other crops that wererun at the sametime). 

### CAM =

### 5forcotton and mustard seedtreatment simulations.
Master Project File Created: 2010-10-07 at 10:56:07 Express v. 1.03.02 (2007-07-20) Parent Compound: Clothianidin Scenario Group File: 1 1STDEFED.GRP Scenario Type: 3 PRZM Crop Selector: 00000000000000000000000000000000000000010000110000 PRZM Crop Selector: 00000001000110000110000001110010010100001000011000 PRZM Crop Selector: 00000001010100000000000000000100000000000000000000 PRZM Crop Selector: 00100010111000001000000000000000000000000000000000 Chemical Input Data Controls: 1 1 0 1 0 Express Operational Mode: OPP Chemical Name(s) : Clothianidin 

## I Molecular Weight: 249.7 Plant Uptake Factor: 0.000 Partition Coefficient Method: 1

Partition Coefficient Value: 160.0 160.0 Vapor Pressure: 0.2900E-12 Solubility : 3270. Soil Degradation Half-Life: 745.0 % Degradate formed: 0.000 0.000 Foliar Half-Life: 0.000 Foliar Washoff Coefficient: 0.5000

Air Diffusion Coefficient: 4300.

Enthalpy of Vaporization: 20.00 Application DataSets Number: 27 Application Parameters: 1 2 1 2 1 0 0 Days Relative/Absolute 0 Month 0 CAM 1 Depi (cm) : 4.000 Rate : 0.2000 Drift Farm Pond % : 1.000 Drift Index Reservoir % : 6.400 Efficiency % : 99.00 Application Parameters: 1 4 1 2 1 0 0 Days Relative/Absolute 0 Month 0 CAM 5 Depi (cm) : 1.270 Rate : 0.2800E-01 Drift Farm Pond % : 0.000Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir 8 : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond B : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters:Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM ~epi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAMDepi (cm) Rate Drift Farm Pond % : Drift Index Reservoir 8 : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency 8 : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond 8 : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % :Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Product chem./hydr. status:Aerobic Dissipation (days) : Q10 Base Temperature : Q10 Lirnnetic Anaerobic Dissipation(days): Q10 Base temperature: Q10 Benthic Photolysis Half-Life (days): Number of Hydrolysis Obs.: Hydrolysis Temperatures: Hydrolysis C1: 0.000E+00 0.( pH Hydrol. C1: 5.00 Melting Point:



### MASTERINPUT COMPILATION (Project

### File)for EXPRESS PRZM-EXAMS Modeling Interface (includes scenarios for several other crops that were run at the same time). CAM = 

### 8 for cotton and mustard seed treatment simulations.
Master Project File Created: 2010-10-07 at 12:27:57 Express v. 1.03.02 (2007-07-20) Parent Compound: Clothianidin Scenario Group File: 1 1STDEFED.GRP Scenario Type: 3 PRZM Crop Selector: 00000000000000000000000000000000000000010000110000 PRZM Crop Selector: 00000001000110000110000001110010010100001000011000 PRZM Crop Selector: 00000001010100000000000000000100000000000000000000 PRZM Crop Selector: OOlOOOlOlllOOoOOlOOOOOOOOOOOOOOOOOOOOOOOoooooooooo Chemical Input Data Controls: 1 1 0 1 0 Express Operational Mode: OPP Chemical Name(s): Clothianidin 

## I Molecular Weight: 249.7 Plant Uptake Factor: 0.000 Partition Coefficient Method: 1 1

Partition Coefficient Value: 160.0 160.0 Vapor Pressure: 0.2900E-12 Solubility : 3270. Soil Degradation Half-Life: 745.0 8 Degradate formed: 0.000 0.000 0.000 Foliar ~alf-Life: 0.000 Foliar Washoff Coefficient: 0.5000

Air Diffusion Coefficient: 4300.

Enthalpy of Vaporization: 20.00 Application DataSets Number: 27 Application Parameters: 1 2 1 2 1 0 0 87.00 0 Days Relative/Absolute 0 Month 0 CAM 1 Depi (cm) : 4.000 Rate : 0.2000 Drift Farm Pond % : 1.000 Drift Index Reservoir 8 : 6.400 Efficiency 8 : 99.00Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute MonthCAM Depi (crn) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond 8 : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond 8 : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir 8 : Efficiency 8 : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir 8 : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) RateDrift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % :Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond 8 : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM ~epi (cm) Rate Drift Farm Pond 8 : Drift Index Reservoir % : Efficiency 8 : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute Month CAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir % : Efficiency % : Application Parameters: Days Relative/Absolute MonthCAM Depi (cm) Rate Drift Farm Pond % : Drift Index Reservoir 8 : Efficiency % : Product chem./hydr. status: Aerobic Dissipation (days) : Q10 Base Temperature : Q10 Limnetic Anaerobic Dissipation(days) : Q10 Base temperature: Q10 Benthic Photolysis Half-Life (days): Number of Hydrolysis Obs.: Hydrolysis Temperatures: Hydrolysis C1: 0.000E+00 0. pH Hydrol. C1: 5.00 Melting Point:



## SamplePRZM Input

## Files
MISSISSIPPI 

### COTTON SCENARIO, CAM 5 

### FILE NAME 

### =

### MS1Ctt-P.INP
*** Record 1: (A78),TITLE - label for simulation title Express v. 1.03.02 (2007-07-20) **"S Cotton; 8/13/2001 Title of input file Existing *** *** Record 2: (A78),HTITLE 

### - Hydrology Information Title "Yazoo County; MLRA 134; Metfile: W03940.dvf (old:Met13 *** *** Record 3: (2F8.0,18,F8.0,218,514) PFAC,SFAC,IPEIND,ANETD,INICRP,ISCOND ***PFAC SFAC IPEIND ANETD INICRP ISCOND (WDM data sets not used) 7.50E-013.60E-01 02.50E+01 1 1 **

### * *** Record 6: (18) ERFLAG: Flag to calculate erosion 4 *** *** Record 7: (4F8.0,8X,I8,2F8.0) USLEK,USLELS,USLEP,AFIELD,IREG,SLP,HL ***USLEKUSLELS USLEP AFIELD IREG SLP HL 4.90E-011.34E+005.00E-011.00E+Ol 3 6.00 356.80 *** *** Record 8: (18)NDC - Number of different crops simulated; FLITNUM 10 * ** *** Record 9 for Crop 1: (18,3F8.0,18,3(1X,I3),2F8.0) ICNCN,CINTCP,AMXDR,COVMAX,ICNAH,(3)CN,WFMAX,HTMAX ***ICNCNCINTCP AMXDR COVMAX ICNAH CN1 CN2 CN3WFMAX HTMAX 12.00E-016.50E+011.0OE+02 3 89 86 870.00E+001.22E+02 *** *** Record 9A (218): CROPN0,NUSLEC - Crop, Number of USLE C (covermanagement) factors 1 2 6 *** Record 9B: (16!12,12,1X) GDUSLEC,GMUSLEC for each USLEC ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM0105 1605 0106 1606 0107 1607 0108 1608 0109 1609 2209 0110 1610 0111 1611 0112 *** Record 9C: (16(F4.0,1X))- USLEC (USLE Cover management factors) .718 .699 .620 .496 .354 .303 .305 .289 .343 .359 .359 .223 .327 .376 .425 .465 *** Record 9D: (16(F4.0,1X))- MNGN - Manning's N for each USLEC .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .OX4 .014 .014 *** Record 9E: (16(14,1X)) - CN(I1) for each USLEC 86 86 86 86 86 86 86 86 86 86 86 89 89 89 89 89 *** *** Continuation of Records 9B,9C,9D,9E for USLEC 17-26 ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 1612 0101 1601 0102 1602 0103 1603 0104 1604 2504 .494 .500 .517 .532 .549 .567 .591 .617 .667 .705 .014 .014 .014 .014 .014 .014 .014 .014 ,014 .014

89 89 89 89 89 89 89 89 89 89 *

### ** *** Record 10: (18) NCPDS - number of cropping periods 3 0 

### ** * *** Record(s) 11: (2X,312,2X,312,3X,312,18) - dates of crop EMergence, MAturation, and HArvest *** EMD,EMM,IYREM,MAD,MAM,IYRMAT,HAD,HAM,IYRHAR,INCROP ***EMerge MAture HArvest ***DMMYY DDMMYY DDMMYY Crop NO. 010561 070961 220961 1 010562 070962 220962 1 010563 070963 220963 1 010564 070964 220964 1 010565 070965 220965 1 010566 070966 220966 1 010567 070967 220967 1 010568 070968 220968 1 010569 070969 220969 1 010570 070970 220970 1 010571 070971 220971 1 010572 070972 220972 1 010573 070973 220973 1 010574 070974 220974 1 010575 070975 220975 1 010576 070976 220976 1 010577 070977 220977 1 010578 070978 220978 1 010579 070979 220979 1 010580 070980 220980 1 010581 070981 220981 1 010582 070982 220982 1 010583 070983 220983 1 010584 070984 220984 1 010585 070985 220985 1 010586 070986 220986 1 010587 070987 220987 1 010588 070988 220988 1 010589 070989 220989 1 010590 070990 220990 1 *** *** Record 12: (A78) PTITLE - Label for pesticide Chemical Input Data: ** * *** Record 13: (418) NAPS,NCHEM,FRMFLG,DK2FLG *** NAPS NCHEM FRMFLG DK2FLG 3 0 1 0 0 

### ** * *** Record 15: (3A20)Name(s) of pesticides for output titles Clothianidin*

### ** *** Record(s) 16: (2X,312,13,3(12,F5.0,F6.O,F5.O,F5.0)) - application data *** including the application date (APD,APM,IAPYR), WINDAY, and (1)(CAM,DEPI,TAPP,APPEFF,DRFT) ***DMMYYWinCmDepi Tapp Eff Drft CmDepi Tapp Eff Drft CmDepi Tapp Eff Drft 240461 0 5 1.270.07091.000.0000 240462 0 5 1.270.07091.000.0000 240463 0 5 1.270.07091.000.0000 240464 0 5 1.270.07091.000.0000 240465 0 5 1.270.07091.000.0000 240466 0 5 1.270.07091.000.0000 240467 0 5 1.270.07091.000.0000 240468 0 5 1.270.07091.000.0000 240469 0 5 1.270.07091.000.0000 240470 0 5 1.270.07091.000.0000 240471 0 5 1.270.07091.000.0000 240472 0 5 1.270.07091.000.0000 240473 0 5 1.270.07091.000.0000 240474 0 5 1.270.07091.000.0000 240475 0 5 1.270.07091.000.0000 240476 0 5 1.270.07091.000.0000 240477 0 5 1.270.07091.000.0000 240478 0 5 1.270.07091.000.0000 240479 0 5 1.270.07091.000.0000 240480 0 5 1.270.07091.000.0000 240481 0 5 1.270.07091.000.0000 240482 0 5 1.270.07091.000.0000 240483 0 5 1.270.07091.000.0000 240484 0 5 1.270.07091.000.0000 240485 0 5 1.270.07091.000.0000 240486 0 5 1.270.07091.000.0000 240487 0 5 1.270.07091.000.0000 240488 0 5 1.270.07091.000.0000 240489 0 5 1.270.07091.000.0000 240490 0 5 1.270.07091.000.0000 *** *** Record 17: (includesdata for each chemical) (F8.0,3(18,F8.0)) FILTRA, (1)(IPSCND,UPTKF) ***FILT IPSCNDl UPTKFl IPSCND2 UPTKF2 IPSCND3 UPTKF3 0.00E+00 10.00E+00 ** * *** Record 19: (A78) STITLE - label for soil properties Loring Silt Loam; HYDG: C Brief description of soil pr * * * *** Record 20: (F8.0,8X8914) CORED,BDFLAG,THFLAG,KDFLAG,HSWZT,MOC,IRFLAG,ITFLAG,IDFLAG,BIOFLG ***CORED (cm) BD TH KD HS MOC IR IT ID BIO 1.55E+02 000000000 *** *** Record 26: (9F8.0) (l)DAIR, (l)HENRYK, (1)ENPY 4.30E+031.19E-152.OOE+01 **

### * *** Record 33: (18)NHORIZ (total number of soil horizons) 6 *

### ** *** Record 34 for Horizon 1: (I8,8F8.0) HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 11.30E+011.40E+003.85E-010.00E+OOO.OOE+O00.00E+00 *** *** Record 36 for Horizon 1: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO ** * *** Record 37 for Horizon 1: (8X,7F8.0)DPN,THEFC,THEWP,OC,(l)KDs 1.00E-013.85E-011.51E-011.28E+002.05E+00



### 87** * *** Record 34 for Horizon 2: (I8,8F8.0)HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 22.30E+011.40E+003.7OE-010.00E+OOO.OOE+O00.00E+00 *** *** Record 36 for Horizon 2: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * * * *** Record 37 for Horizon 2: (8X,7F8.0)DPN,THEFC,THEWP,OC, (1)KDs 1.00E+003.70E-011.46E-014.90E-017.84E-01 

### *** *** Record 34 for Horizon 3: (18,8F8.0) HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 33.30E+011.40E+003.7OE-010.00E+OOO.OOE+O00.00E+00 *

### ** *** Record 36 for Horizon 3: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * ** *** Record 37 for Horizon 3: (8X,7F8.0) DPN,THEFC,THEWP,OC, (1)KDs 3.00E+003.70E-011.46E-011.60E-012.56E-01 ** * *** Record 34 for Horizon 4: (18,8F8.0)HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 43.00E+011.45E+003.4OE-010.00E+OOO.OOE+O00.00E+00 **

### * *** Record 36 for Horizon 4: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * *

### * *** Record 37 for Horizon 4: (8X,7F8.0) DPN,THEFC,THEWP,OC, (1)KDs 5.00E+003.4OE-O11.25E-011.20E-011.92E-O1 * *

### * *** Record 34 for Horizon 5: (I8,8F8.0)HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 52.30E+011.49E+003.35E-010.00E+OOO.OOE+O00.00E+00 * * * *** Record 36 for Horizon 5: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * * * *** Record 37 for Horizon 5: (8X.7F8.0)DPN,THEFC,THEWP,OC, (1)KDs 1.00E+003.35E-O11.37E-017.00E-O21.12E-O1 *** *** Record 34 for Horizon 6: (18,8F8.0)HORIZN,THKNS,BD,THETO,AD,(I)DISP,ADL 63.30E+011.51E+003.43E-010.00E+OOO.OOE+000.00E+00 *** *** Record 36 for Horizon 6: (8X, 9F8.0) (l)DWRATE,(l)DSRATE, (1)DGRATE 9.30E-049.30E-040.00E+OO 

### ** * *** Record 37 for Horizon 6: (8X,7F8.0)DPN,THEFC,THEWP,OC,(l)KDs 3.00E+003.43E-011.47E-016.00E-029.60E-02 * * * *** Record 40: (218) ILP; CFLAG (blank if ILP=O) 0 *** *** Record 42: (3(4X,A4,4X,A4, I8), 14) ITEMl,STEP1,LFREQl,ITEM2,STEP2,LFREQ2,ITEM3,STEP3,LFREQ3,E~FLG WATR YEAR 10 PEST YEAR 10 CONC YEAR ** * *** Record 43: (18) EXMENV 9 9 *** *** Record 44 for Chemical 1: EXMCHM,CAS Number,NPROC,RFORM,YIELD 1 CASSNO: 999 1 10.00E+00 * * * *** Record 45: NPLOTS (number of time series variables,STEP4 0 YEAR * ** *** Records 46: Plotting variables

### NORTH CAROLINA COTTON SCENARIO, CAM 5 FILE NAME =

### NC 1Ctt-P.INP
*** Record 1: (A78),TITLE - label for simulation title Express v. 1.03.02 (2007-07-20) *** NCcottonTitle of input file Develope 

### *** *** Record 2: (A78),HTITLE - Hydrology Information Title "MLRA 133A; Metfile: W13722.dvf (old:Metl33A.met)," Sh * * * *** Record 3: (2F8.0,18,F8.0,218,514) PFAC,SFAC,IPEIND,ANETD,INICRP,ISCOND ***PFAC SFAC IPEIND ANETD INICRP ISCOND (WDM data sets not used) 7.50E-013.60E-01 01.75E+01 1 1 *** *** Record 6: (18) ERFLAG: Flag to calculate erosion 4 

### *** Record 7: (4F8.0,8X,I8,2F8.0) USLEK,USLELS,USLEP,AFIELD,IREG,SLP,HL ***USLEKUSLELS USLEP AFIELD IREG SLP HL 3.40E-011.34E+001.00E+001.00E+01 3 6.00 356.80 **

### * *** Record 8: (18) NDC 

### - Number of different crops simulated; FLITNUM 10 *** *** Record 9 for Crop 1: (18,3F8.0,18,3(1X,I3),2F8.0) ICNCN, CINTCP,AMXDR, COW, ICNAH,( 3) CN, WFMAX, HTMAX ***ICNCNCINTCP AMXDR COVMAX ICNAH CN1 CN2 CN3WFMAX HTMAX 12.00E-016.50E+011.0OE+02 3 92 89 900.00E+001.22E+02 *** *** Record 9A (218): CROPN0,NUSLEC - Crop, Number of USLE C (cover management) factors 1 2 5 *** Record 9B: (16(12,12,1X) GDUSLEC,GMUSLEC for each USLEC ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 0106 1606 0107 1607 0108 1608 0109 1609 0110 1610 0111 1611 0112 1612 0101 1601 *** Record 9C: (16(F4.0,1X))- USLEC (USLE Cover management factors) .640 .511 .364 .311 .314 .299 .359 .376 .228 .326 .362 .396 .427 .460 .474 .504 *** Record 9D: (16(F4.0,1X))- MNGN - Manning's N for each USLEC .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 *** Record 9E: (16(14,1X)) - CN(I1) for each USLEC 89 89 89 89 89 89 89 89 89 89 92 92 92 92 92 92 *** *** Continuation of Records 9B,9C,9D,9E for USLEC 17-25 ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 0102 1602 0103 1603 0104 1604 2504 0105 1605 .532 .557 .584 .615 .645 .707 .741 .748 .720 .014 .014 .014 .014 .014 .014 .014 .014 .014

92 92 92 92 92 92 92 92 92 * * * *** Record 10: (18)NCPDS - number of cropping periods 3 0 *** *** Record(s) 11: (2X, 312,2X, 312,3X, 312,18) - dates of crop EMergence, MAturation, and HArvest *** EMD,EMM,IYREM,MAD,MAM,IYRMAT,HAD,HAM,IYRHAR,INCROP ***EMergeMAture HArvest ***DMMYY DDMMYY DDMMYY Crop No. 010661 010861 011161 1 010662 010862 011162 1 010663 010863 011163 1 010664 010864 011164 1010665 010865 011165 010666 010866 011166 010667 010867 011167 010668 010868 011168 010669 010869 011169 010670 010870 011170 010671 010871 011171 010672 010872 011172 010673 010873 011173 010674 010874 011174 010675 010875 011175 010676 010876 011176 010677 010877 011177 010678 010878 011178 010679 010879 011179 010680 010880 011180 010681 010881 011181 010682 010882 011182 010683 010883 011183 010684 010884 011184 010685 010885 011185 010686 010886 011186 010687 010887 011187 010688 010888 011188 010689 010889 011189 010690 010890 011190 * *

### * *** Record 12 : (A78) PTITLE Chemical Input Data: *** - Label for pesticide

*** Record 13: (418)NAPS,NCHEM,FRMFLG,DK2FLG *** NAPS NCHEM FRMFLG DK2FLG 30 1 0 0 * * * *** Record 15: (3A20)Name(s) of pesticides for output titles Clothianidin 

### * ** *** Record(s) 16: (2X,312,13,3(12,F5.0,F6.O,F5.O,F5.0)) - application data *** including the application date (APD,APM,IAPYR), WINDAY, and ( 1) (CAM, DEPI ,TAPP,APPEFF ,DRFT) ***DMMYYWinCmDepiTapp Eff Drft CmDepi Tapp Eff Drft CmDepi Tapp Eff Drft 250561 0 5 1.270.07091.000.0000 250562 0 5 1.270.07091.000.0000 250563 0 5 1.270.07091.000.0000 250564 0 5 1.270.07091.000.0000 250565 0 5 1.270.07091.000.0000 250566 0 5 1.270.07091.000.0000 250567 0 5 1.270.07091.000.0000 250568 0 5 1.270.07091.000.0000 250569 0 5 1.270.07091.000.0000 250570 0 5 1.270.07091.000.0000 250571 0 5 1.270.07091.000.0000 250572 0 5 1.270.07091.000.0000 250573 0 5 1.270.07091.000.0000 250574 0 5 1.270.07091.000.0000 250575 0 5 1.270.07091.000.0000 250576 0 5 1.270.07091.000.0000 250577 0 5 1.270.07091.000.0000 250578 0 5 1.270.07091.000.0000 250579 0 5 1.270.07091.000.0000 250580 0 5 1.270.07091.000.0000 250581 0 5 1.270.07091.000.0000 250582 0 5 1.270.07091.000.0000250583 0 5 1.270.07091.000.0000 250584 0 5 1.270.07091.000.0000 250585 0 5 1.270.07091.000.0000 250586 0 5 1.270.07091.000.0000 250587 0 5 1.270.07091.000.0000 250588 0 5 1.270.07091.000.0000 250589 0 5 1.270.07091.000.0000 250590 0 5 1.270.07091.000.0000 * * * *** Record 17: (includes data for each chemical) (F8.0,3(18,F8.0)) FILTRA, ( 1) ( IPSCND,UPTKF) ***FILT IPSCNDl UPTKFl IPSCND2 UPTKF2 IPSCND3 UPTKF3 0.00E+00 10.00E+00 *** *** Record 19: (A78) STITLE - label for soil properties "Boswell, sandy loam, HYDG: D" Brief description of s ** * *** Record 20: (F8.0,8X,914) CORED,BDFLAG,THFLAG,KDFLAG,HSWZT,MOC,IRFLAG,ITFLAG,IDFLAG,BIOFLG ***CORED (cm) BD TH KD HS MOC IR IT ID BIO 1.00E+02 000000000 *** *** Record 26: (9F8.0) (l)DAIR, (l)HENRYK, (1)ENPY 4.30E+031.19E-152.00E+01

C C I *** Record 33: (18)NHORIZ (total number of soil horizons) 3 * * * *** Record 34 for Horizon 1: (I8,BFg.O)HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 11.00E+011.80E+002.13E-010.00E+OOO.OOE+OOO.OOE+OO *** *** Record 36 for Horizon 1: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * *

### * *** Record 37 for Horizon 1: (8X,7F8.0) DPN,THEFC,THEWP,OC, (1)KDs 1.00E-012.13E-016.30E-O22.32E+OO3.71E+OO * * * *** Record 34 for ~orizon 2: (18,gFg.O)HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 22.00E+001.80E+002.13E-01O.OOE+OOO.OOE+OOO.OOE+OO * * * *** Record 36 for Horizon 2: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO *** *** Record 37 for Horizon 2: (8X,7F8.0) DPN,THEFC,THEWP,OC,(l)KDs 2.OOE+002.13E-016.30E-O22.32E+OO3.71E+OO ** * *** Record 34 for Horizon 3: (18,8F8.0) HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 38.80E+011.70E+003.54E-010.00E+OOO.OOE+OOO.OOE+OO * *

### * *** Record 36 for Horizon 3: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO *** *** Record 37 for Horizon 3: (8X,7F8.0) DPN,THEFC,THEWP,OC,(l)KDs 4.00E+003.54E-012.13E-012.90E-014.64E-01 *** *** Record 40: (218) ILP; CFLAG (blank if ILP=O) 0 * * * *** Record 42: (3(4X,A4,4X,A4,18], 14) ITEMl,STEPl,LFREQl,ITEM2,STEP2,LFREQ2,ITEM3,STEP3,LFREQ3,EXMFLG WATR YEAR 10 PEST YEAR 10 CONC YEAR 10 1 *** *** Record 43: (18) EXMENV



### 91*** Record 44 for Chemical 1: EXMCHM,CAS Number,NPROC,RFORM,YIELD 1 CASSNO: -999 1 10.00E+00 *** *** Record 45: NPLOTS (number of time series variables,STEP4 0 YEAR *** *** Records 46: Plotting variables


### NORTH DAKOTA CANOLA SCENARIO, CAM

### 5 FILE NAME =

### ND 1 Cno-P. INP
*** Record 1: (A78),TITLE - label for simulation title Express v. 1.03.02 (2007-07-20) *** NDCanolaTitle of input file "Existin * * * *** Record 2: (A78),HTITLE - Hydrology Information Title "Cavalier County, ND MLRA 55a; Metfile: W24013.dvf (Old * * * *** Record 3: (2F8.0,18,F8.0,218,514) PFAC,SFAC,IPEIND,ANETD,INICRP,ISCOND ***PFAC SFAC IPEIND ANETD INICRP ISCOND (WDM data sets not used) 7.60E-013.60E-01 01.25E+01 1 1 ** * 

### *** Record 6: (18) ERFLAG: Flag to calculate erosion 4 * * * *** Record 7: (4F8.0,8X,I8,2F8.0) USLEK,USLELS,USLEP,AFIELD,IREG,SLP,HL ***USLEKUSLELS USLEP AFIELD IREG SLP HL 2.80E-012.5OE-O11.00E+001.OOE+O1 3 1.50 356.80 

### * ** *** Record 8: (18)NDC - Number of different crops simulated; FLITNUM 10 *

### ** *** Record 9 for Crop 1: (18,3F8.0,18,3(lX,I3),2F8.0) ICNCN,CINTCP,AMXDR,COVMAX,ICNAH, (3)CN,WFMAX,HTMAX ***ICNCNCINTCP AMXDR COVMAX ICNAH CN1 CN2 CN3WFMAX HTMAX 11.OOE-O11.2OE+O21.OOE+02 3 87 82 830.00E+001.25E+02 ** * *** Record 9A (218):CROPN0,NUSLEC - Crop, Number of USLE C (covermanagement) factors 1 2 9 *** Record 9B: (16(12,12,1X) GDUSLEC,GMUSLEC for each USLEC ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 1605 0106 1606 0107 1607 0108 0508 1008 1608 2508 0109 1609 0110 1610 0111 1611 *** Record 9C: (16(F4.0,1X))- USLEC (USLE Cover management factors) .562 .468 .268 .092 .064 .065 .036 .098 .I10 .I10 .I26 .I39 .I52 .I62 .I68 .I70 *** Record 9D: (16(F4.0,1X))- MNGN - Manning's N for each USLEC .014 .014 .014 ,014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 *** Record 9E: (16(I4,lX) ) - CN(I1) for each USLEC 82 82 82 82 82 82 82 82 82 82 87 87 87 87 87 87 *** *** Continuation of Records 9B,9C,9D,9E for USLEC 17-29 ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 0112 1612 0101 1601 0102 1602 0103 1603 0104 1604 2004 0105 0505 .I71 .I71 .583 .581 .579 .577 .574 .574 .575 .575 .611 .617 .610 -014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014

87 87 87 87 87 87 87 87 87 87 87 87 87 * ** *** Record 10: (18)NCPDS 

### - number of cropping periods 2 8 * * **** Recordls) 11: (2X,312,2X,312,3X,312,18) - dates of crop EMergence, MAturation, and HArvest *** EMD,EMM,IYREM,MAD,MAM,IYRMAT,HAD,HAM,IYRHAR,INCROP ***EMerge MAture HArvest ***DMMYY DDMMYY DDMMYY Crop NO. 160561 150861 250861 1 160562 150862 250862 1 160563 150863 250863 1 160564 150864 250864 1 160565 150865 250865 1 160566 150866 250866 1 160567 150867 250867 1 160568 150868 250868 1 160569 150869 250869 1 160570 150870 250870 1 160571 150871 250871 1 160572 150872 250872 1 160573 150873 250873 1 160574 150874 250874 1 160575 150875 250875 1 160576 150876 250876 1 160577 150877 250877 1 160578 150878 250878 1 160579 150879 250879 1 160580 150880 250880 1 160581 150881 250881 1 160582 150882 250882 1 160583 150883 250883 1 160584 150884 250884 1 160585 150885 250885 1 160586 150886 250886 1 160587 150887 250887 1 160588 150888 250888 1 * ** *** Record 12: (A78) PTITLE - Label for pesticide Chemical Input Data: *

### ** 

### *** Record 13: (418)NAPS,NCHEM,FRMFLG,DK2FLG *** NAPS NCHEM FRMFLG DK2FLG 2 8 1 0 0 * * * 

### *** Record 15: (3A20)Name(s) of pesticides for output titles Clothianidin * * * *** Record(s) 16: (2X,312,13,3(12,F5.0,F'6.0,F5.O,F5.0)) - application data *** including the application date (APD,APM,IAPYR), WINDAY, and (1)(CAM, DEPI, TAPP, APPEFF, DRFT) ***DMMYYWinCmDepi Tapp Eff Drft CrnDepi Tapp Eff Drft CrnDepi Tapp Eff Drft 090561 0 5 1.270.03141.000.0000 090562 0 5 1.270.03141.000.0000 090563 0 5 1.270.03141.000.0000 090564 0 5 1.270.03141.000.0000 090565 0 5 1.270.03141.000.0000 090566 0 5 1.270.03141.000.0000 090567 0 5 1.270.03141.000.0000 090568 0 5 1.270.03141.000.0000 090569 0 5 1.270.03141.000.0000 090570 0 5 1.270.03141.000.0000 090571 0 5 1.270.03141.000.0000 090572 0 5 1.270.03141.000.0000 090573 0 5 1.270.03141.000.0000 090574 0 5 1.270.03141.000.0000 090575 0 5 1.270.03141.000.0000*** Record 17: (includesdata for each chemical) (F8.0,3(18,F8.0)) FILTRA, (1)(IPSCND, UPTKF) ***FILT IPSCNDl UPTKFl IPSCND2 UPTKF2 IPSCND3 UPTKF3 0.00E+00 10.00E+00 *

### * * *** Record 19: (A78) STITLE - label for soil properties Hamerly loam; HYDG: C Brief description of soil proper *** *** Record 20: (F8.0,8X,914) CORED,BDFLAG,THFLAG,KDFLAG,HSWZT,MOC,IRFLAG,ITFLAG,IDFLAG,BIOFLG ***CORED (cm) BD TH KD HS MOC IR IT ID BIO 1.50E+02 000000000 *

### * * *** Record 26: (9F8.0) (l)DAIR, (l)HENRYK, (1)ENPY 4.30E+031.19E-152.00E+01 *** *** Record 33: (18)NHORIZ (totalnumber of soil horizons) 4 

### *** *** Record 34 for Horizon 1: (18,8F8.0)HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 11.00E+011.48E+002.24E-010.00E+OOO.OOE+OOO.OOE+OO *** *** Record 36 for Horizon 1: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * * * *** Record 37 for Horizon 1: (8X,7F8.0)DPN,THEFC,THEWP,OC, (1)KDs 1.00E-012.24E-011.08E-012.36E+003.78E+00 * * * *** Record 34 for Horizon 2: (I8,8F8.0) HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 21.50E+011.48E+002.24E-010.00E+OOO.OOE+O00.00E+00 

### * * * *** Record 36 for Horizon 2: (8X,9F8.0) (l)DWRATE, (l)DSRATE, (1)DGRATE 9.30E-049.30E-040.00E+OO * * * *** Record 37 for Horizon 2: (8X,7F8.0) DPN,THEFC,THEWP,OC,(l)KDs 5.00E+002.24E-011.08E-012.36E+003.78E+00 *

### ** *** Record 34 for Horizon 3: (18,8F8.0) HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 32.50E+011.48E+O02.24E-010.00E+OOO.OOE+O00.00E+00 *

### ** 

### *** Record 36 for Horizon 3: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO * * * *** Record 37 for Horizon 3: (8X.7F8.0) DPN,THEFC,THEWP,OC, (1)KDs 5.00E+002.24E-011.08E-018.20E-011.31E+00 *** *** Record 34 for Horizon 4: (18,8F8.0) HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 41.00E+021.48E+002.28E-010.00E+OOO.OOE+O00.00E+00 ***** Record 36 for Horizon 4: (8X, 9F8.0) (1) DWRATE,(1) DSRATE,(1) DGRATE 9.30E-049.30E-040.00E+OO **

### * *** Record 37 for Horizon 4: (8X,7F8.0)DPN,THEFC,THEWP,OC, (1)KDs 5.00E+O02.28E-011.10E-012.50E-014.00E-01 *** 

### *** Record 40: (218) ILP; CFLAG (blank if ILP=O) 0 *** 

### *** Record 42: (3(4X,A4,4X,A4,18), 14) ITEM~,STEP~,LFREQ~,ITEM~,STEP~,LFREQ~,ITEM~,STEP~,LFREQ~,E~FLG WATR YEAR 10 PEST YEAR 10 CONC YEAR 10 3 *** *** Record 43: (18) EXMENV 9 9 *** *** Record 44 for Chemical 1: EXMCHM,CAS Number,NPROC,RFORM,YIELD 1 CASSNO: -999 1 10.00E+00 *** *** Record 45: NPLOTS (number of time series variables,STEP4 0 YEAR

k * * *** Records 46: Plotting variables



### CALIFORNIA COTTON SCENARIO, CAM5 FILE NAME =

### CAI

### Ctt-P.INP
*** Record 1: (A78),TITLE - label for simulation title Express v. 1.03.02 (2007-07-20) *** "CaCotton.xls- Created August 6, 2001" Title of i * ** *** Record 2: (A78),HTITLE 

### - Hydrology Information Title "Fresno County, CA - MLRA 17, Metfile: W93193.dvf (old: * * * *** Record 3: (2F8.0,18,F8.0,218,514) PFAC,SFAC,IPEIND,ANETD,INICRP,ISCOND ***PFAC SFAC IPEIND ANETD INICRP ISCOND (WDM data sets not used) 7.30E-010.00E+OO 01.75E+01 1 1 ** * *** Record 6: (18) ERFLAG: Flag to calculate erosion 4 *** *** Record 7: (4F8.0,8X,I8,2F8.0) USLEK,USLELS,USLEP,AFIELD,IREG,SLP,HL ***USLEKUSLELS USLEP AFIELD IREG SLP HL 2.1OE-O13.7OE-O11.OOE+OO1.OOE+O1 1 2.50 356.80 * ** *** Record 8: (18)NDC - Number of different crops simulated; FLITNUM LO ** * *** Record 9 for Crop 1: (18,3F8.0,18,3(lX,I3),2F8.0) ICNCN,CINTCP,AMXDR,COVMAX,ICNAH, (3)CN,WFMAX,HTMAX ***ICNCNCINTCP AMXDR COVMAX ICNAH CN1 CN2 CN3WFMAX HTMAX 12.00E-016.50E+011.0OE+02 3 89 86 870.00E+001.22E+02 *** *** Record 9A (218):CROPN0,NUSLEC - Crop, Number of USLE C (covermanagement) factors 1 26 *** Record 9B: (16(12,12,1X) GDUSLEC,GMUSLEC for each USLEC ***M DDIYIM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 0105 1605 0106 1606 0107 1607 0108 1608 0109 1609 0110 1610 0111 1111 1611 0112 *** Record 9C: (16(F4.0,1X))- USLEC (USLE Cover management factors)

,.I61 .085 -062 .062 .062 .054 .054 .054 .054 .054 .055 .091 .098 .098 .lo8 .I23 *** Record 9D: (16(F4.0,1X)) - MNGN - Manning's N for each USLEC .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 *** Record 9E: (16(14,1X))- CN(I1) for each USLEC 86 86 86 86 86 86 86 86 86 86 86 86 86 86 89 89 *** *** Continuation of Records 9B,9C,9D,9Efor USLEC 17-26 ***M DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM DDMM 1612 0101 1601 0102 1602 2502 0103 1603 0104 1604 .I37 .I57 .I75 .I96 .351 -395 .412 .392 .337 .259 .023 .023 .023 .023 .023 .023 .023 .023 .023 ,023

89 89 89 89 89 89 89 89 89 89 *** *** Record 10: (18)NCPDS - number of cropping periods 3 0 *** *** Record(s) 11: (2X,312,2X,312,3X,312,18) - dates of crop EMergence, MAturation, and HArvest *** EMD,EMM,IYREM,MAD,MAM,IYRMAT,HAD,HAM,IYRHAR,INCROP ***EMerge MAture HArvest ***DMMYY DDMMYY DDMMYY Crop No. 010561 200961 111161 1 010562 200962 111162 1 010563 200963 111163 1 010564 200964 111164 1 010565 200965 111165 1 010566 200966 111166 1 010567 200967 111167 1 010568 200968 111168 1 010569 200969 111169 1 010570 200970 111170 1 010571 200971 111171 1 010572 200972 111172 1 010573 200973 111173 1 010574 200974 111174 1 010575 200975 111175 1 010576 200976 111176 1 010577 200977 111177 1 010578 200978 111178 1 010579 200979 111179 1 010580 200980 111180 1 010581 200981 111181 1 010582 200982 111182 1 010583 200983 111183 1 010584 200984 111184 1 010585 200985 111185 1 010586 200986 111186 1 010587 200987 111187 1 010588 200988 111188 1 010589 200989 111189 1 010590 200990 111190 1 **

### * *** Record 12: (A78) PTITLE - Label for pesticide Chemical Input Data: *** *** Record 13: (418)NAPS,NCHEM,FRMFLG,DK2FLG *** NAPS NCHEM FRMFLG DK2FLG 3 0 1 0 0 *** *** Record 15: (3A20) Name(s) of pesticides for output titles Clothianidin *** *** Record(s) 16: (2X,312,13,3(12,F5.O,F6.O,F5.O,F5.0)) - application data



### 96*** including the application date (APD,APM,IAPYR), WINDAY, and ( 1) (CAM, DEPI,TAPP, APPEFF, DRFT) ***DMMYYWinCmDepi Tapp Eff Drft CmDepi Tapp Eff Drft CmDepi Tapp Eff Drft 240461 0 5 1.270.07091.000.0000 240462 0 5 1.270.07091.000.0000 240463 0 5 1.270.07091.000.0000 240464 0 5 1.270.07091.000.0000 240465 0 5 1.270.07091.000.0000 240466 0 5 1.270.07091.000.0000 240467 0 5 1.270.07091.000.0000 240468 0 5 1.270.07091.000.0000 240469 0 5 1.270.07091.000.0D00 240470 0 5 1.270.07091.000.0000 240471 0 5 1.270.07091.000.0000 240472 0 5 1.270.07091.000.0000 240473 C 5 1.270.07091.000.0000 240474 0 5 1.270.07091.000.0000 240475 0 5 1.270.07091.000.0000 240476 0 5 1.270.07091.000.0000 240477 0 5 1.270.07091.000.0000 240478 0 5 1.270.07091.000.0000 240479 0 5 1.270.07091.000.0000 240480 0 5 1.270.07091.000.0000 240481 0 5 1.270.07091.000.0000 240482 0 5 1.270.07091.000.0000 240483 0 5 1.270.07091.OOO.OOOO 240484 0 5 1.270.07091.000.0000 240485 0 5 1.270.07091.000.0000 240486 0 5 1.270.07091.000.0000 240487 0 5 1.270.07091.000.0000 240488 0 5 1.270.07091.000.0000 240489 0 5 1.270.07091.000.0000 240490 0 5 1.270.07091.000.0000 *** *** Record 17: (includes data for each chemical) (F8.0,3(18,F8.0)) FILTRA, (1) (IPSCND,UPTKF) ***FILT IPSCNDl UPTKFl IPSCND2 UPTKF2 IPSCND3 UPTKF3 0.00E+00 10.00E+00 * * * *** Record 19: (A78) STITLE - label for soil properties Twisselman Clay - Hydg: C Brief description of soil pr * * * *** Record 20: (F8.0,8X,914) CORED,BDFLAG,THFLAG,KDFLAG,HSWZT,MOC,IRFLAG,ITFLAG,IDFLAG,BIOFLG ***CORED (cm) BD TH KD HS MOC IR IT ID BIO 1.00E+02 000002000 *** *** Record 26: (9F8.0) (l)DAIR, (l)HENRYK, (1)ENPY 4.30E+031.19E-152.00E+01 *** *** Record 27 (18,3F8.0)IRTYP,FLEACH,PCDEPL,RATEAP- irrigation specifications ***IRTYPFLEACH PCDEPL RATEAP 41.00E-015.50E-017.4OE-02 *** *** Record 33: (18) NHORIZ (totalnumber of soilhorizons) 3 * *

### * *** Record 34 for Horizon 1: (18,8F8.0) HORIZN,THKNS,BD,THETO,AD,(l)DISP,ADL 11.00E+011.45E+003.6OE-O1O.OOE+OOO.OOE+OOO.OOE+OO * * * *** Record 36 for Horizon 1: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO ****** Record 37 for Horizon -1: (8X,7F8.0)DPN,THEFC,THEWP,OC, (1)KDs 1.00E-013.60E-012.20E-012.90E-014.64E-01 *** *** Record 34 for Horizon 2: (I8,8F8.0) HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 22.60E+011.50E+003.6OE-010.00E+OOO.OOE+OOO.OOE+OO *** *** Record 36 for Horizon 2: (8X, 9F8.0) (l)DWRATE, (l)DSRATE, (1)DGRATE 9.30E-049.30E-040.00E+OO * * * 

### *** Record 37 for Horizon 2: (8X,7F8.0)DPN,THEFC,THEWP,OC,(l)KDs 2.00E+003.60E-012.20E-012.90E-014.64E-01 *** *** Record 34 for Horizon 3: (18,8F8.0)HORIZN,THKNS,BD,THETO,AD, (l)DISP,ADL 36.40E+011.60E+003.17E-010.00E+OOO.OOE+OOO.OOE+OO *** *** Record 36 for Horizon 3: (8X,9F8.0) (l)DWRATE,(l)DSRATE,(l)DGRATE 9.30E-049.30E-040.00E+OO 

### *** *** Record 37 for Horizon 3: (8X,7F8.0)DPN,THEFC,THEWP,OC,(l)KDs 4.00E+003.17E-011.97E-011.74E-012.78E-01 * ** *** Record 40: (218) ILP; CFLAG (blank if ILP=O) 0 * * * *** Record 42: (3 (4X,A4,4X,A4,18), 14) ITEMl,STEPl,LFREQl,ITEM2,STEP2,LFREQ2,ITEM3,STEP3,LFREQ3,EmFLG WATR YEAR 10 PEST YEAR 10 CONC YEAR 10 1 *** *** Record 43: (I81 EXMENV 9 9 * * * *** Record 44 for Chemical 1: EXMCHM,CASNumber,NPROC,RFORM,YIELD 1 CASSNO: -999 1 10.00E+00 * ** *** Record 45: NPLOTS (number of time series variables,STEP4 0 YEAR * ** *** Records 46: Plotting variables



## ...................................................................

## Table ofEstimatedEnvironmental Concentrations from PRZM-EXAMS
CAM =5 

### for SeedTreatments, 

### CAM 

## = 1

### or 2

### for surfaceapplications (pond waterEECs): 

## Upper 10th Percentile Limnetic 

## EECs in 

## FarmPond Chemical

# - Clothianidin Scenarios 

# I lmtantaneous 

# / 96-Hour 

# I 2l-Day 

# I GO-Day 

# I 90-Day 

# I Annual 

# I

RUN ID: GAlOni-P 31 .4 31.2 30.6 29.3 27.9 18.6 RUN ID: FLlCar-P 17.4 17.2 16.8 15.9 14.4 9.15 

### RUN ID: FLICuc-P 

### 1 10.8 ( 10.8 ( 10.6 

### 1 10.2 

### 1 8.85 

### 1 6.13 

### 1 RUN ID: FLlPep-P 

### 1 10.6 

### 1 10.8 

### 1 10.4 

### 1 9.85 

### 1 9.44 

### 1 8.06 (



### IRUN ID: NCICtt-P ( 3.00 

### 1 2.98 

### 1 2.91 

### 1 2.82 

### 1 2.78 ( 2.18 

### 1 RUN ID: FLICbb-P RUN ID: PAITur-P RUN 10: FLITur-P 5.58 4.47 3.05

RUN ID: NY2Gra-P RUN ID: FLlTrna-P RUN ID: CAlGra-P RUN ID: MSISyb-P RUN ID: CAlOni-P

(RUN ID: MEIPm-P 

### 1 0.265 

### 1 0.265 

### 1 0.264 

### 1 0.260 

### 1 0.258 

### 1 0.214 

### 1 RUN 10: P A1Trna-P RUN ID: NCITba-P RUN ID: NDIWhe-P RUN ID: NDICno-P RUN ID: CAlCtt-P 

### RUN ID: MSICor-P ( 0.152 ( 0.151 

### 1 0.148 

### 1 0.141 

### 1 0.137 ( 0.106 

### 1 5.54 4.46 3.04

2.26 1.15 1.I1 1.07 1.07

(RUN ID: IL1Cor-P 

### I O.672E-01 

### I 0.668E-01 

### I O.663E-01 

### I 0.641E-01 

### 1 0.623E-01 

### 1 0.508E-01 

### 1 0.998 0.983 0.798 0.491 0.310 5.43 4.39 2.97

2.25 1.I4 I .I0 1 .07 I .06



### 1 RUN ID: NC1Cor-P ( 0.305E-01 

### I O.304E-01 

### I 0.302E-01 ( 0.296E-01 

### I 0.292E -01 

### 1 0.224E -01 

### I 0 .Q9# 0.977 0.793 0.488 0.309

RUN ID: OH1Car-P 5.22 4.28 2.85

2.23 1.I1 1.08 1.05 1.04 0.978 0.955 0.782 0.480 0.308

RUN ID: P A1 Cor-P 

### I 0.369E-01 

### 1 0.367E-01 

### 1 0.362E-01 

### 1 0.351E-01 

### 1 0.344E-01 

### 1 0.302E-01 

### 1 0.556E-01 4.82 4.14 2.76

2.16 1.07 I .02 1.Ol 0.997 3.42 3.41 2.17

0943 0.935 0.770 0.462 0.300

0.553E-01 2.13 1.08 0.993 0.976 0.987 1.65 0.829 0 701 0.708 0.729 0.016 0.91 6 0.757 0.450 0.296

0.53QE -01 0.759 0.893 0.829 0.367 1 0.224

O.524E-01 0.51OE -01 O.438E -01

### CAM 

### =8for Seed Treatments,

### CAM 

### = 1

### or2

### for surface applications (pond water EECs):


## Upper 10th Percentile Limnetic EECs 

## in Farm Pond Chemical

# - Clothianidin

RUN ID: OHICor-P RUN ID: PAlCor-P RUN ID: IDlPa-P RUN ID: MElPat-P RUN ID: MSISyb-P RUN 10: NDlWhe-P Eqea u. 103m @@?07.@- bans29BD+D8uihPRZU3.122[q 0.00 0.00 0.00 0.00 0 .OO 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0 .00 0.00 0.00 0.00 0.00 0.00 0.00 0 .OO 0 .OO 0.00 0.00 0.00 0 .OO 0 .00 0 .OO 0 .00 0 .OO 0 .00 0.00 0 .OO 0 .OO 0 .00 0.00 0.00

### CAM = 

### 8

### for Seed Treatments,CAM = 

### 1

### or 2 for surface applications (benthicpore water EECs): 

## Upper 

## 10th Percentile Benthic 

## EECsin FarmPond Chemical

# - Clothianidin

bpree u. lmD.2 @O?U-~QJ- hs2~1I+D6uih P~3.122[(8]