UNSTED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

## Environmental Pate and Ecological Risk Assessment New Chemical Registration (Section 3) Spirotetramat CAS NO. 203313-25-5 PC Code 392201

Page 

### 1 of 

### 120TABLE OF CONTENTS 

### I

# . Executive Summary 

## ........................................................................................................................ 4 A

# . Nature of Chemical Stressor

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



## .................................... B

# . Assessment of Potential Risks to Non-Listed Non-Target Organisms 4



## ...................................................... C

# . Assessment of Potential Risks to Federally Listed Species 6 D

# . Exposure Characterization


### ............................................................... : 

## .......................................7



### ............................................................................................................. E

# . Effects Characterization 8



### .................................................................................................... . F

# . Uncertainties and Data Gaps 9



## ................................................................................................................... 1



# . Environmental Fate 9 

### 2

# . Ecological Effects

## ..................................................................................................................... 11 

### I1

# . Problem Formulation 

## ................................................................................................................... 13 A

# . Nature of Regulatory Action


### ....................................................................................................... 13



## ................................................................................................ B

# . Stressor Source and Distribution 13



### .......................................................................................... 1



# . Nature of the Chemical Stressor 13 

### 2

# . Overview of Pesticide Usage


### ...................................................................................................14 C

# . Receptors 

### ................................................................................................................................14 

### 1



# . Aquatic and Terrestrial Effects


### ............................................................................................. 15

a

# . Degradates 

## ........................................................................................................................... 16 b

# . Formulations 

## ....................................................................................................................... 17 c

# . Chronic

## ................................................................................................................................. 17 2

# . Ecosystems Potentially at Risk

## ............................................................................................ 18 D

# . Assessment Endpoints 

## ................................................................................................................ 18 E

# . ConceptualModel 

## ..................................................................................................................... 18 1

# . Risk Hypothesis 

## .................................................................................................................... 19 

### 2

# . Conceptual Diagram 

## ............................................................................................................ 19 F

# . Analysis Plan 

## ............................................................................................................................. 21



## ............................................ 1

# . Preliminary Identification of Data Gaps and Analysis Plan 21 

### 2

# . Measures of Exposure and Effects

## ...................................................................................... 21 111

# . Analysis 

## ......................................................................................................................................... 23 A

# . Use Characterization


### ................................................................................................................. 23 B

# . Exposure Characterization 

## ........................................................................................................27



## ......................................................... 1



# . Environmental Fate and Transport Characterization 27



## .............................................................................................. a

# . Summary of Empirical Data 29 b

# . General 

## ................................................................................................................................. 30 c

# . Degradation


### ....................................................................................................................... 30 d

# . Metabolism and Transformation Products


### ...................................................................... 31



### .............................................................................. e

# . Soil Sorption,Mobility and Transport 33 f

# . Field Dissipation


### ................................................................................................................. 33 g

# . Bioaccumulation

## .................................................................................................................. 34 h

# . Uncertainties and Issues


### ..................................................................................................36



## ............................................................................................... 2

# . Measures of Aquatic Exposure 37 a

# . Aquatic Exposure Modeling


### ............................................................................................37



### ...................................................................... b

# . Aquatic Exposure Monitoring (Field Data) 45



## .......................................................................................... 3

# . Measures of Terrestrial Exposure 45 a

# . Exposure Modeling: Non-Target Mammals and Birds


### .................................................. 45 b

# . Exposure Modeling: Non-target Invertebrates


### ............................................................... 48 c

# . Exposure Modeling: Non-Target Plants Inhabiting Dry (Upland) and Semi-Aquatic Page 

### 2 of 120(Wetland) Areas 

## ........................................................................................................................... 48 C

# . Ecological Effects Characterization 

## ........................................................................................... 49 1

# . Toxicity Data Summary

### ..........................................................................................................50 2

# . Aquatic Toxicity 

## ..................................................................................................................... 53 a

# . Acute Effects

## ....................................................................................................................... 53 b

# . Chronic/Reproductive Effects

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

### 3

# . Terrestrial Toxicity

## .................................................................................................................. 54 a

# . Terrestrial Vertebrates


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



### ................................................................................................................... i

# . Acute Effects 54 

### ii

# . Chronic/ReproductiveEffects


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

. b

# . TerrestrialInvertebrates 

## ...................................................................................................56



### ................................................................................................................ c

# . Terrestrial Plants 58 IV

# . Risk Characterization


### .................................................................................................................. 60



## ................................................... A

# . Risk Estimation 

## - Integration of Exposure and Effects Data 60 

### 1

# . Risks to Non-Target Aquatic Organisms


### ..............................................................................60 2

# . Risks to Non-Target Terrestrial Organisms

## ........................................................................ 62 a

# . Risks to Non-Target Birds


### .................................................................................................. 62 b

# . Risks to Non-Target Mammals


### .......................................................................................... 64



## ................................................................. c

# . Risks to Non-Target Terrestrial Invertebrates 65 d

# . Risks to Non-Target Plants Inhabiting Dry (Upland) and Semi-Aquatic (Wetland) Areas 

### ............................................................................................................................................ 65 

### B

# . Risk Description

## ........................................................................................................................... 66



## .............................................................................. 1



# . Risks to Non-Target Aquatic Organisms 68



## .......................................................................... 2

# . Risks to Non-Target Terrestrial Organisms 70



## ....................................................................................... a

# . Non-Target Birds and Mammals 71 c

# . Non-Target Terrestrial Invertebrates


### ...............................................................................76



## ........ d

# . Non-TArget Plants Inhabiting Dry (Upland) and Semi-Aquatic (Wetland) Areas 79



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

# . 4 Endocrine Effects 79



## ................................................ V

# . Federally Listed Threatened and Endangered Species Concerns 80 A

# . Action Area

## .................................................................................................................................. 80 B

# . Taxonomic Groups Potentially atRisk 

## ......................................................................................81 

### 1 Discussion of Risk Quotients 

## .................................................................................................. 81 2

# . Probit Dose Response Relationship

## ....................................................................................... 82 C

# . Indirect Effects Analysis 

## ............................................................................................................. 85 D

# . Critical Habitat 

## ............................................................................................................................ 85 E

# . Co-occurrence Analysis 

## ............................................................................................................. 86 

### VI

# . Literature Cited 

## .......................................................................................................................... 87 List of Amendices Appendix A

# . Fate and Behavior Data Summaries Appendix B

# . Information About PRZM/EXAMS Runs Appendix C

# . EcologicalEffects Data Summaries Appendix 

### D

# . Final Ecotoxicology Reporting Table Appendix E

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

# . Sample T-REX Model Output Appendix G

# . TerrPlant Appendix 

### H

# . Summary of Endangered Species Appendix I

# . Categories of Acute Toxicity Page 3 of 120

### I. Executive Summary A. Nature of Chemical Stressor 

### Spirotetramat (CASNo. 2033 13-25-5; CAS Name 

### cis-3-(2,5-dimethylpheny1)-8-methoxy-2-0x0-1- 

### azaspiro[4.5]dec-3-en-4-y1 ethyl carbonate;IUPAC Name 

### cis-4-(ethoxycarbony1oxy)-8-methoxy-3-(2,5- xyly1)-1 

### -azaspiro[4.5]dec-3-en-2-one) is a systemic broad spectrumtetramic acid insecticide (ketoenole) that is to be applied as a preventative treatment during an early threshold of developing chewing insect populations including aphids, whiteflies and mealy bugs, when sufficient leaf tissue is present for uptake and translocation to occur within agricultural crops. Spirotetramat's mode of action is lipid biosynthesis inhibition 

### (LBI), which is classified as a Group 23 Insecticide. According to the proposed label, "is active primarily by ingestion against immature insect life stages." Three products are formulated as suspension concentratesandlor oil dispersions (MoventoTM SC, 2 lb a.i./gal; UltorTM SC, 1.25 lb a.i./gal; and, PYI 

### 8330 OD 

### 1.25 lb a.i./gal) and are proposed for use on citrus fruits, grapes and small hit climbing, pome hits, stone hits,tree nuts plus pistachio, hops, Christmas trees, cucurbitvegetables, fruiting vegetablesplus okra, leafy vegetables, brassica (cole) leafy vegetables, and potatoes and other tuberous and corm vegetables. The end-use-products(EUP) 

### may be applied by air, ground equipment (includingairblast), or through chemigation (sprinkler-type irrigation systems only), and are recommended to be tank-mixed with a spray adjuvant (or additive)that enhancesthe systemic nature of spirotetramatby aiding infiltration, penetration, and translocation of or within leaves and root systems. There are two possible stereoisomersof spirotetramat, cis- and trans-isomers;but only the cis-isomer is the active material. The ratio of cis- to trans-isomers is about 98:2. Spirotetramat's major transformation product, spirotetramat-enol, is the product of the hydrolytic cleavage of the ester bond in the parent, resulting in an alcohol. Spirotetramat-en01is further oxidized at the benzylic carbon to yield spirotetramatketohydroxy, another major metabolite. For the structure of spirotetramat, and its major metabolites, please, refer to Tables III.2 

### and 111.4, respectively. Although acute toxicity data with aquatic receptors suggest that the degradates are equivalent to (for duckweed) or lower in toxicity than the parent (all other instances) for the taxonomic groups tested, the dataset is incomplete and there is insufficient evidence for drawing the same conclusion for terrestrial organisms. Therefore, this assessment conservativelyassumed equivalent toxicity among them and includedthe two transformation products in exposure modeling and subsequent risk calculations. The potential presence of these major metabolites was accounted for because they may be of concern in soils, sediments, and water due to their high concentrationsin the laboratory studies (spirotetramat-enol) and their persistence relativeto the parent (spirotetramat-ketohydroxy). 

### B. Assessment of Potential Risks to Non-Listed Non-Target Organisms 

### This is the Environmental Fate and Effects Division's (EFED) national screening level ecological risk assessment for the proposed registration of the new active ingredient spirotetramat.Table 1.1 

### summarizes the major conclusions and uncertainties of this assessment for aquatic and terrestrial receptors. Functionally, the estimated risks may translate to reduced survival and reproduction of impacted species with subsequent effects at higher levels ofbiological organization.

Page 4 of 

### 120Page 5 of 120 to 

### All Freshwater and EstuarinelmarinePlants quotients (RQs) for all aquatic animals and plants are below the Agency's screening levels of concern (LOCs). Although actual chronic risk estimateswere not derived for estuarinelmarineorganisms, acute toxicity estimates appear to be roughly equivalentin sensitivity to those for freshwater organisms, and the low chronicrisk to freshwaterfish

Chronic risk estimates for birds are based upon a non-definitive NOAEC of <28.8 mglkg-diet (effectswere seen at all tested concentrations)and all RQs are greaterthan the reported values. Therefore, until a discreteNOAEC is establishedfor chronic/reproductiveeffectsto birds, it is impossibleto preclude chronicrisk to birds feeding on any forage item under any exposure scenario. Although further discussionofthis uncertainty is provided in

Acute and Chronic Risks to Mammals Risks to Upland and Wetland Plants

Risks to TerrestrialNonTarget Insects None

None

Acute and Chronic the "Risk Description" section of the risk assessment, it is important to note that even based on the currentNOAEC, dietary-based chronic RQs for avian species feeding on short grass meet or exceed the chronic risk LOC for all but two of the evaluated crop use scenarios for both the parent-only (RQ range = B0.82 to B1.50) and total residues approaches (RQ range =B0.93 to B1.82). In addition, the RQ for birds feeding onbroadleafplantsJsmal1insects under the pome hit scenario when using the total residue approach also currently exceeds the chronic risk LOC (RQ = B1.02). The best available information and the results ofthe most conservative scenario considered demonstrated that all acute and chronic RQs for mammals are below the Agency's LOCs. The best available information suggests that even under the most conservativeexposure scenario consideredin this assessment, all RQs for upland and wetland monocots and dicots adjacent to the application site, are below the listed and non-listed plant species LOC. However, due to the systemic nature of spirotetramat,the potential for cumulative effects to plants resulting from combined routes of exposure including root uptake are unclear because current guideline studies do not address potential effects from this route of exposure. Therefore, the potential implications for upland and wetland plant risk estimates remain uncertain. Currently, the Agency does not quantitatively evaluate the potential exposure and risk of terrestrial invertebratesto pesticides for screening level assessments for non-endangered species. However, risks to nontarget listed and non-listed insects cannotbe precluded. Although the intrinsic hazard potential to bees based on the acute oral and contact studies with honey bees appears to be low, brood feeding tests with bees and acute toxicity contact studies with other non-target insects (e.g. parasitoid wasps and predatory mites) conducted at less than theC. 

### Assessment of Potential Risks to Federally Listed Species Table 1.2 summarizes the conclusions of potential concerns for direct and indirect effects to federally-listed threatened and endangered species (listed species). Additional discussion isincluded in Section V (''Federally Listed Threatened and Endangered Species Concerns") of this assessment. maximum application rate suggest there is potential for mortality in adults and pupae, massive perturbation ofbrood development, and early brood termination as a result of spirotetramat use. In addition, data on two other chemicals representing the ketoenole class of compounds (spiromesifen and spirodiclofen) also demonstrate that compounds with this mode of action (i.e., inhibition of lipid biosynthesis) may adversely affect bee broods and developmentwhile displaying low acute toxicity. Although EFED has no currentway to quantitatively estimate exposure and risk to earthworms and soil-dwelling organisms, if one assumes that all of the applied spirotetrarnatwithin a year is applied directly to soil, a very crude estimate of exposure can be derived to qualitatively compare to toxicity estimates. Based on this approach, it appears that risk to soil-dwellingorganisms is likely to be low. Risks to Earthworms None

Page 6 of 

### 120 No LOCs were Terrestrial invertebrates,birds

Terrestrial invertebrates
Mammals Aquatic plants (vascular and nonvascular)

Fish, aquatic amphibians2 Aquatic Invertebrates 

## 'Birds areused as surrogate species for terrestrial-phaseamphibians andreptiles; therefore,potentialdirectand indirect effectsto endangered avian,repand amphibian species are consideredequivalent. No
No
No No No LOCs were exceeded No LOCs were exceeded No LOCs were exceeded No LOCs were exceeded Yes
Yes
Yes Yes Terrestrial invertebrates
Terrestrial invertebrates Terrestrial invertebrates, birds, terrestrial amphibians, and reptiles ~irdk, terrestrial amphibians, and reptilesIconsidered eauivalent. 

### I D. Exposure Characterization 

### Spirotetramat may degrade1transform through various routes, which include hydrolysis in alkaline media, photolysis in natural water and biodegradation in aerobic and anaerobic environments, both in soil and aquaticmedia (calculated half-dissipation times or DTS03s range <<I-2.8 days). Hydrolysis in neutral and acidic environments @T50y~ 8.6-47.6 days at pH's 4-7 and 20-25°C) and photolysis in sterile buffered solution (DT50= 

### 14.4Phoenix, AZ days) appear to be routes of transformationof lower importance for spirotetramat. For the soil metabolism studies, the proposed transformation pathway involves the hydrolytic cleavage of the spirotetramat ester moiety into spirotetramat-en01(assumed to be quantitative); subsequently, spirotetramat-en01is oxidized at the benzylic carbon position into spirotetramatketohydroxy. Spirotetramat-en01may further yield other minor transformation products. Several of the metabolism studies follow a similar transformationpathway. (For the structure and nomenclature of spirotetramat and its major metabolites, please, refer to Tables 

### 111.2 and 

### III.4, respectively. Also, refer to Pig. 

### 111-1, for the proposed metabolic pathway of spirotetramat.) Spirotetramat-en01is also generally short lived in aerobic soil environments(DTSo <1 day), but could be more persistentto hydrolysis or in aquatic or anaerobic media (stable to hydrolysis; DTS0 = 

### 37.9-59.0 days to aerobic aquatic metabolism; stable to anaerobic soil and aquatic metabolism). Spirotetramatketohydroxy showed DTSOYs ranging from 1.5 to 16.7 days in aerobic soils [maximum of 24.0% of the appliedradioactivity (AR)]. 

### These results are generally supportedby an aerobic outdoors study in which spirotetramat degraded quickly (DTSOY 

### s of 1.1-2.9 days in two soils). One likely route of exposureto spirotetramatto aquatic environmentswill be from the contamination of surfacewaters from runoff events occurring shortly after application to a few days after application. There is also the chance that the chemical would be deposited off-targetby spray drift. Spirotetramatis not generally expected to be an important leacher (despite its moderately mobile classification), for its low persistence. Similarroutes of exposure will be observed for spirotetramat-enol, since it is the product of the rapid breakdown of the parent. It appears that parent spirotetramat and its major metabolites spirotetramat-en01and spirotetramatketohydroxy may be of concern in soils and water due to their high concentrationsin the laboratory studies (for the parent and spirotetramat-enol) or to their relative persistence (for spirotetramat-ketohydroxy). 

### The soils may also be repositories of toxic residues since high levels of non-extracted residues were observed in metabolism studies (up to 60% of

### AR). The total residues of spirotetramat, spirotetramat-enol, spirotetramat-ketohydroxy

### and non-extracted residues are much more persistent than the parent or its major metabolites alone. Half-lives (tl/,'s) of 161 -204 days were estimated from the aerobic soil metabolism studies for spirotetramat-en01

## + spirotetramat-ketohydroxy 

## +non-extracted residues; while half-lives of 141-693days were estimated hom the aerobic aquatic metabolism studies for spirotetramat

## + spirotetramat-en01 

### + spirotetramat-ketohydroxy 

### +non-extracted residues. The registrant indicated that the non-extracted residues were immobile and not accessible; however, no data to supportthis contention were provided. A conservative approach was taken and for the half-life calculation, it was assumed that the Page 7 of 

### 120

### non-extracted residues were persistent compounds. Due to their higher persistence, moderate to high solubility, and relatively low levels ofbinding, spirotetramatresidues of concern (i.e. 

### spirotetramat, spirotetramat-enol, 

### spirotetramat-ketohydroxy and non-extracted residues) have a potential to contaminate adjacent bodies of water for periods of weeks to several months posttreatment due to runoff events (both via dissolution or erosion). In addition, there is some potential to move subsurface and contaminategroundwater. It appears that spirotetramatandor its residues may be incorporated translocated into the targeted crop/ canopy/ foliage (leaves and shoots) or young root systems with the aid of an adjuvant added to the applicationmixture. While the total residues are available, the chewing insects will take them. These chemicals could also be released via plant washoff to soils environments during large rain events. The photolysis studies followed different patterns of transformation/ degradation than the soil and aquatic studies. Under aqueous photolysis condition, in sterile natural water at a pH 7.9, spirotetramat degraded with a dark controled corrected half-dissipation time (DT50) of 0.74 Phoenix, AZ 

### days. Two major phototransformation products were formed besides the hydrolysis product spirotetramat-enol:methoxy

### cyclohexylamino-carboxylic acid and methoxy-cyclohexanone (1 1.3-17.5%of AR). 

### In contrast, under aqueousphotolysis condition, in sterile buffered solution at a pH of 5, spirotetramat degraded with a DT50 of 14.4Phoenix, AZ 

### days. In buffered solution, spirotetramatis transformed to the major photorearrangement products 

### spirotetramat-photo-cyclopentyl, 

### spirotetramat-photo-hydroxymethyl, spirotetramat-photo-2-formyl and 

### spirotetramat-photo-2-methyl carbonate (1 1542.9%AR). Furthermore, the soilphotodegradation studywas found to have certain deficienciesthat one could not draw definite conclusions on the rate of soil photodegradation. Information on the identity of the degradates in the study indicated that spirotetramat-enol, 

### spirotetramat-ketohydroxy, methoxycyclohexanone (1 0% AR) and dimethylbenzoic acid (2 1.8% of AR) were observed in the samples. Methoxy-cyclohexanone and dimethylbenzoic acid were observed only in the irradiated samples. For spirotetramat (mean 

## I& =

### 4.39 rnLIg; mean &C = 

### 289 mL/gOc),spirotetramat-en01(mean 

### Gc = 

### 55 mI,/goc) and 

### spirotetramat-ketohydroxy's (mean 

## I&= 

### 1.067rnLIg; mean 

### hc = 

### 65.3 mL/goc), mobility was classified as moderately mobile, mobile and mobile to highly mobile, respectively (according to the FA0mobility classification). Given the low vapor pressure of spirotetramat(4.2~10-l1 mmHg) 

### and its low Henry's Law Constant (6.90~10-l3 ~tm-m3/mol), the chemical and its residues are not expected to volatilize readily or substantially from wet surfaces. Terrestrial field dissipation studies, with a pH range of 7.0 - 

### 8.1 (in water, equivalent to -5.5 - 

### 7.3 in CaC12),conducted in NY, 

### FL, CA and WA, also confirmthe laboratory findings of rapid degradation1 dissipationof spirotetramat @T50'~ of 0.3-1.0 days, in the 0-45 cm soil layer). The major transformation products found in the field are likelyto be spirotetramat-en01and spirotetramat-ketohydroxy. Theywere not present at significant amounts below the 0-15-cm soil layer. Half-dissipation times for the combined residues of spirotetramat-en01and spirotetramat-ketohydroxyranged fiom 4.6-3 1.6 days, in the 0-45 cm soil depth. Spirotetramat-MA-arnide was also monitored in the field, with very limited detections. Spirotetramat, spirotetramat-en01and spirotetramat-ketohydroxyarenot likely to bioaccumulate/ bioconcentrate because their Gw'sare low: 324,2.1 and 20, respectively (or <<1000). E. Effects Characterization 

### The limited available data for formulated products suggested no concern for enhanced toxicity of formulations versus the active ingredient alone. Therefore, regardless of whether data are for the technical Page 8 of 120

### grade or the formulations, they have been considered for use in this assessment and are used to characterize toxic effects of spirotetramatbelow. While acute toxicity data with aquatic receptors suggest that the degradates are equivalent to (for duckweed) or lower in toxicity than the parent (all other instances) for the taxonomic groups tested, the dataset is incomplete and there is insufficient evidence for drawingthe same conclusion for mammals, birds, gamasid mites, and earthworms. Therefore,this assessment conservatively assumes equivalent toxicity among them. Spirotetramat can be classified as practically non-toxic to birds and mammals on an acute basis. Although there currently is no toxicity classification schemefor earthworms, spirotetramat appears to be ofrelatively low toxicityto earthworms asthere were no observed toxic effects up to the highest concentrationtested in the sub-chronic 14-day study. Only a 14-day study with 4-methoxy-cyclohexanone and an 8-week study with spirotetramat-en01demonstrated any toxic effects to earthworms. Although spirotetramat can be classified as practicallynon-toxic to honey bees based on acute oral and contact studies, results of brood feeding studies and tunnel tests suggest the potential for effects to broods following spirotetramat applications at rates lower than the maximum proposed label rates; significant brood effects including increased mortality in adults and pupae, massive perturbation of brood development, early brood termination, and decreased larval abundancewere detected. Spirotetramat also had a wide range in magnitude of acute effects on other various non-target terrestrial arthropods. For plants inhabitingdry and semi-aquatic areas, there were no detrimental effects for any measured parameter in dicots or monocots at or above 25% 

### as compared to the controls in the Tier I 

### seedling emergence study. However, there were some significant adverse effects observed on a number of monocots (corn, oats, ryegrass, and shattercane)in the available vegetative vigor studies, including: reduced shoot 

### dryweight, reduced length, and fiesh weight. The only dicot affected was canola (reduced fresh weight). Spirotetramat can be classified as moderately toxic to freshwater and estuarinelmarine fish, slightlyto highly toxic to freshwater invertebrates, and moderately to highly toxic to estuarinelmarineinvertebrates on an acute basis. Although there is no toxicity classification scheme for aquatic vascular and non-vascular plants, toxic effects were demonstratedin the available studies with duckweed (yield and growth) and algae (biomass and growth rate). There is the also the potential for chronic andlorreproductive effects resulting from spirotetramatuse as demonstrated in studies with birds (e.g., Jmean hatchling bodyweight, J # 

### of 14-daysurvivors, J # 

### of viable 14-day embryos, j.# 

### of live embryos, and J# of eggs hatched), mammals (e.g., j. 

### body weight and body weight gain in 

### parental and offspring generations, f 

### abnormal sperm cells and 

## 4 reproductive performance in parentalmales), fish (e.g., Jfi-y survival),midges (Jemergence and developmental rate), and water fleas (Jreproduction, Jparental growth, and f

### mortality in adults). 

### F. Uncertainties and Data Gaps 1. 

### Environmental Fate 

### The environmental fate data base is essentiallycomplete. However, monitoring data specific for spirotetramat or its residues in U.S. groundwater, drinking water, surface water, and sediment have not been identified. Page 9 of 120

### The available soilphotodegradation study, provides only limited supplemental information and isuncertain because the parent in the dark control samples degraded faster than in the light exposed samples. However, from the study, the degradates dimethyl-benzoic acid (21.8% of the applied radioactivity or AR at 7 days, also observed in the aerobic outdoors study at 3.3% of the AR) and methoxycyclohexanone (10.0% of

### AR at 2 days, also observed in the aqueous photolysis study conducted with sterilenatural water at 17.5%of AR) were identified only in the light exposed samples, in addition to other transformation products identified in other biodegradation studies (e.g., 

### spirotetramat-en01and spirotetramatketohydroxy). The amount of such degradates and the rate of soil photodegradationon soil are uncertain. 

### In order to obtain an 

### adequatedescription of the role of soil photodegradationon the environmentalfate of spirotetramat, and the presence and quantities of degradation1transformation products, a new photodegradation on soil study, conducted on a sterile soil is required. There is uncertainty with one of the five soils used in the batch equilibrium study performed in the parent spirotetramat for which the taxonomic classificationis unknown. Theregistrant provided "Orthic dark brown" as the soil taxonomic classification for the soil (not a soil taxonomic classification). Due to the sampling location, it is believed to be of the suborder Mollisols. This part of the study is considered supplemental. The soil taxonomy for the 'Saskatoon' loam soil (from Saskatchewan, Canada) constitutes a data gap. Spirotetramat-en01 dimers 1 and 2, at up to 5.0 and 7.0% of

### AR, respectivelyin the soil metabolism studies, were 51.5% of 

### AR in the aerobic outdoors study and <0.2%in the field. It is speculated that this may be due to the "hot spots" application method used for spirotetramatin aerobic soil metabolism studies. In the "hot spots" application method, utilized in the laboratory studies, spirotetramatwas applied in acetonitrileat relatively high concentrations. It is argued due to the type of application, spirotetramat may have been concentrated in small regions or sectors (referred to as "hot spots") in/ 

### on the soil, causing an increased formation of the dimers. For the tests conductedwith spirotetramat-en01(with higher solubility, the test substancewas applied dissolved in water and, hence, at lower concentrations) and in the aerobic outdoors study 

### and in the field (with broadcast application of the formulated product, oil dispersion), the levels of the dimers were lower. There is uncertaintywith respect to the possible presence in the environmentof the aqueous photolysates from the study conducted in sterilebuffer solution, compared to thosephotolysates observed in the study conducted in natural water. The major transformation products were spirotetramat-photo-cyclopentyl (maximum 42.9% of AR at 7 days), spirotetramat-photo-methyl(22.9%

### of AR at 6 days), spirotetramatphoto-formyl(11.5% of AR at 3 days) and 

### spirotetramat-photo-methyl(19.3% of 

### AR at 6 

### days), in sterile buffer solution (pH 

### 5, in a studylasting 7 

### days). These transformation products were not observed in the photolysis study conducted with sterile natural water. Spirotetramat-enol's pKa is 5.2, which suggests that it may be ionizable at environmentally relevant pH's; however, the DTS07s for spirotetramat-en01did not appear to depend on the soilpH's in aerobic soil metabolism studiesconducted in four soils. Nonetheless, the ionization potential of spirotetramat-en01 could affect the mobility of the chemical with the soil pH (at high pH's high concentrations of the "enolate" form of the chemical would occur and higher mobility is expected). In the soil column leaching studies, the range ofpH's was 6.1-6.5 for three 

### EU soils and it was 5.4 for the FL SL (as measured in CaC12solution); all the derived &'s 

### were within a relatively thin range (0.52-0.86) and the KoC's did not appear to follow a pattern with the pH's.

Page 

### 10 of 120

### The availableKoc's for spirotetramat-en01were estimated fiom a series of soil column leaching studies instead of the conventional batch equilibrium study. There is uncertainty in those values since the chemicalis labile under various metabolism conditions; furthermore, it was found that spirotetramat-en01is too labile to withstand a batch equilibrium study (even with sterile soils). There is uncertainty related to the high levels of non-extracted residues observed very early on in the aerobic soil metabolism studies conducted with spirotetramat (22-35% of AR) 

### and spirotetramat-enol(40- 60% of 

### AR). The registrant indicated that these residues were immobile, but it is unknown if they are bioavailable. For the purpose of calculation of the half-life of the total residues of spirotetramat (parent, spirotetramat-en01 and spirotetramat-ketohydroxy),the non-extracted residues were added as if they were persistent compounds. The maximum rate of application for spirotetramat to cucurbit vegetables, fruiting vegetables, leafy vegetables and brassica (cole) leafy vegetable crops is 0.08 lb a.i./A with a maximum of 2 applications1 season and a minimum interval of 7 

### days between applications (a total maximum seasonal application rate of 0.16 lb a.i./A). However, for this risk assessment EFED assumed that spirotetramat was applied at a maximum of 2 times per year. If there are conditions under which there is more than one growing season for a crop within a singleyear, exposure estimates and risk to aquatic and terrestrial organisms could be significantlyunderestimated. Examples of crops that have multiple seasonswhere this may be a concern include leafy, brassica, and fruiting vegetables in CA, AZ, FL, GA, LA, NC, TX, andlor SC. 2. 

### Ecological Effects In agreement with international governmental partners associated with registration efforts for this pesticide, ecological effects data evaluation and approval responsibilities are being met through the efforts of the Austrian Agency for Health and Food Safety (AGES). The Agency is using the results of the AGES review as they appear in Volume 3, Annex B.9: Ecotoxicology monograph for registration in Europe. It shouldbe noted that except where specifically reported, independent validation of statistical results for effects studies was not performed during the AGES reviews. In addition, a number of studies on Movento 240 SC have been submittedbut were not formally reviewedby AGES prior to this assessment. However, a cursoryreview of the data suggeststhat all formulationsare ofroughly equivalent or lower toxicity than the technical grade active ingredient. Unless the studies were found to contain the most sensitive endpoint available for a given taxonomic group based on a cursoryEFED review, or they had been reviewed previouslyby AGES, their details are not discussed within the body of this assessment. AGES found that the ecological effects database was largely complete and that all studies were acceptable for risk assessment purposes. However, a few additional data needs have been identified by EFED as described below. OPPTS Guideline 850.2300; Avian Revroduction Studvwith the Mallard Duck 

### (Anas platvrh.vnchos): A definitiveNOAEC based on the available avian reproduction studies has not been established for spirotetramat; adverse reproductive effects were observed at the lowest tested concentrationin the available avian reproduction studywith mallards. The most sensitiveNOAEC value of <28.8 mgkg-diet with which chronic avian RQs were calculated, was based on a statistically significant-6.58% reduction in mean hatchlingbodyweight. Although no additional statistically significant effects were observed at this test level, largereductions in other frank effects that were observed at 28.8 mgkg-diet included reductions in # 

### of 14-daysurvivors (J22%), # 

### of viable 

### 14-dayembryos (Jla%), # 

### of live 

### embryos (Jla%), and # 

### of eggs hatched (J22%). Due to the degree of thesereductions, it is hard to indicate that these effects are not biologically significant and are considered meaningful. Thus, because of the extent of these observed Page 

### 11 of 

### 120

### effects, it is reasonable to assume they are significantbiologically.Therefore, the abilityof this study to statistically detect what could be considered to be biologically relevant endpoints appears to be limited, and an additional studyis needed to reduce uncertaintyby establishing a definitiveNOAEC capable of capturingbiologically relevant reductions 

### in endpoints. OPPTS Guideline 850.3040; Field Testing for Pollinators Despite that the intrinsichazard potential to bees based on the acute oral and contact studies with honey bees appearsto be low, brood feeding tests with bees and acute toxicity contact studies with other nontarget insects (e.g. parasitoid wasps and predatory mites) conducted at less than the maximum application rate suggest there is potential for mortality 

### in adults and pupae, massive perturbation ofbrood development, and early brood termination as a result of spirotetramatuse. This information, coupled with the fact that two other chemicals representing the ketoenole class of compounds (spiromesifen and spirodiclofen) have also demonstratedthe potential for chronic effects on bee broods and development while displaying low acutetoxicity, suggests that the mode of action of these compounds (i.e., inhibition of lipid biosynthesis) may adversely affectbee broods and development. Although 

### a studyhas been submitted for spirotetramat under guideline 850.3040, it was conducted at application rates approximately half of the label-recommended rates and it was not designed in such a manner that adverse effects resulting from treatment couldbe statistically determined. Therefore, it is recommended that a studydesign be developed in collaboration with the EnvironmentalFate and Effects Division. In the interim, the following protectivepollinator label language is recommended: "This product is potentially toxic to honey bee larvae through residues in 

### pollen and nectar, but not to adult honey bees. Exposure of adult bees to direct treatment or residues on blooming crops can lead to effects on honey bee larvae. See the "Directionsfor Use" section of this label for specific crop application instructions that minimize risk to honey bee larvae." OPPTS Guideline 850.1075; FreshwaterFish Toxicitywith Fathead Minnows (Pimephalesoromelas): Under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticideproducts, it is stated that if 

### the speciesused in a single fish early-life stage toxicity test is different from the two species used for the freshwater fish acute toxicity tests, an additional 96hour on the speciestested in the early-life stage studymust be submitted. These conditions apply to spirotetramat and an additional study is requested to fill this data gap. These data would help to reduce the uncertainty associated with chronic risk estimates for freshwater fish. OPPTS Guideline 850.2100: Avian Oral Toxicity Studvwith a Passerine Species: Under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticideproducts, it is stated that data arerequired on one passerine species in addition to either one waterfowl species or one upland gamebird species for terrestrial, aquatic, forestry, and residential outdoor uses. Currently there are no acute oral toxicity studieswith passerine species available for spirotetramat. These data would be helpful for characterizing interspecies sensitivity, and testing of a passerine addresses concerns that broad, untested avian taxa may be more sensitive than previously required mallards and bobwhites. Data in reserve 

### OPPTS Guideline 850.1350; Aauatic invertebratelife-cvcle (EstuarineMarine): Chronictoxicity data for estuarinelmarineinvertebrates would be conditionally required under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticide products since the most sensitive acute ECso is <lmg/L and the highest estimated environmentalconcentration (EEC) in water is 

### 10.01 of the acute 

### ECS0.However, these toxicity estimates are.basedon toxicity to the Page 

### 12 of 

### 120

### eastern oyster, yet the chronic life-cycle studywith estuarinelmarine invertebratesis conducted with mysids. Based on mysid toxicity data, these requirements would not be met. In addition, acute toxicity studies suggest that freshwater and estuarinelmarineorganisms are equally sensitive to spirotetramat, and currently there are no risk concerns for freshwater fish and invertebrates. Therefore, although the value of the studyin this present risk assessment is low, the study is being held in reserve pending a request for new use patterns. 

### II. Problem Formulation 

### The purpose of this problem formulation is to provide the foundation for the ecological risk assessment being conducted for Spirotetrarnat. As such, it articulates the purpose and objectives of the risk assessment, evaluatesthe nature of the problem, and provides a plan for analyzing the data and characterizingthe risk (EPA, 1998). A. Nature of RegulatoryAction 

### Under the authority of the Federal Insecticide, Fungicide and RodenticideAct (FERA), the registrant, Bayer Cropscience is seekingthe Section 3 

### registration for the new active ingredient, Spirotetramat, for use as an insecticide. This section of the report summarizesthe Environmental Fate and Effects Division's Problem Formulation for the Section 3 

### Registration of the chemical. B. Stressor Source and Distribution 1. 

### Nature of the Chemical Stressor 

### Spirotetramatis a new systemic (xylem and phloem mobile) broad spectrum insecticide. It is effective against chewing insects. It acts by ingestion. Its mode of action (MoA) is lipid biosynthesis inhibition 

### (LBI). According to this MoA, it is classified as a Group 23 Insecticide. A brief summary of the product chemistry data on Spirotetramat is provided in Table 

### II.1.

Page 13 of 

### 120

### Spirotetramat shows various major routes of dissipation:hydrolysis in alkaline media, photolysis in natural water, and biodegradation in aerobic and anaerobic environments(DTS03s range 4-2.8 days). Hydrolysis in acid and neutral media and photolysis in buffered solutions are routes of dissipation of lesser importance (half-lives 8.6-47.6 days). It appears that spirotetramatmay be translocated,with the aid of an adjuvant, into young foliage (or young root systems), or breakdown into its residues. It may also washoff into the soil environment, where it degrades to spirotetramat-en01(theoretically a stoichiometric conversion), which subsequentlydegrades in aerobic environments to spirotetramat-ketohydsoxy

### (maximum 24.0% in the aerobic soil metabolism study) or to various other transformation products. It may also photolyze. Spirotetramattotal residues (spirotetramat

## +transformation products spirotetramat-en01

## + spirotetramatketohydroxy 

## +non-extracted residues) are relatively more persistent than the parent or the metabolites alone (tl/,'sof 161-204 days for aerobic soil metabolism and 141 -693 days for aerobic aquatic metabolism). Spirotetramat is considered moderately mobile according to the FA0 mobility classification (mean Koc of 289 mL/g), while both, spirotetramat-en01and spirotetrarnat-ketohydroxyare considered mobile (respectivemean 

### he's of 55 mL/goc and 65.3 mLlgoc). The later two are major transformation products in the aerobic soil metabolism studies. Spirotetramat-en01 was a product of the hydrolysis as well. Both chemicals were observed in an outdoor metabolism studyperformed with two soils and 

### in all four terrestrial field dissipation studies. UVNis Absorption Spectra



### Although both spirotetramat-en01and spirotetramat-ketohydroxy

### appear to be less toxic than parent based on acute toxicity testing with aquatic receptors, these major metabolites could be of concern in soils, sediments, and water due to their high concentrationsin the laboratory studies (spirotetramat-enol) and their persistence relativeto the parent (spirotetramat-ketohydroxy). In addition, there is insufficient evidence based on effects data to discount the potential contribution of these degradates to the overall risk to mammals and birds from use of spirotetramat. Ethyl acetate 67 Ethanol 44 PeakMaxima MolarAbsorptivitv burity 99.2%) (nm) (1000 cm2/ moo 211 22.0 x 103 276 0.8~ 

### ld

2. Overview of Pesticide Usage 

### The products involved in this Section 3 

### (new chemical) are MOVENTOTM, BY1 8330 150 OD and ULTORTM, which are formulated as a suspension concentratesor as an oil dispersion, containing 1.25 lb a.i. per gallon or 2 lb a.i. per gallon. They are applied foliarly and the maximum total application rate in 

### a season is 0.4 lb a.i./A. The chemicalmay be applied by air, ground equipment, airblast or through chemigation. The proposed labels include uses on citrus fruits (Crop Group 1 O), grapes and small fi-uit climbing (exceptkiwifruit), pome fruits (Crop Group 1I), stone fruits (Crop Group 12),tree nuts (Crop Group 14plus Pistachio), hops, Christmas trees, cucurbit vegetables (Crop Group 9), hitingvegetables (Crop Group 8 plus okra), leafy vegetables (Crop Group 4), brassica (cole) leafy vegetables (Crop Group 5), and potatoes and other tuberous and corm vegetables (Crop Subgroup 1C). Due to the fact that spirotetramat is a broad spectrum insecticide, and it is used on multiple crops, it is anticipated that it will be used in multiple regions of the country. C. Receptors Page 

### 14 of 

### 120

### 1. Aquatic and Terrestrial Effects 

### The receptor is the biological entity that is exposed to the stressor (EPA, 1998.) Due to the outdoor uses of spirotetramat, this screening level risk assessment approachesthe analysis for adverse effects through the use ofbroad plant and animal taxonomic groups including: Birds (also used as surrogate for terrestrial-phase amphibians and reptiles), Mammals, Terrestrial plants, Freshwater fish (also used as a surrogatefor aquatic phase amphibians), Freshwater invertebrates (including sediment-dwelling species), EstuarineMarine Fish EstuarineMarine Invertebrates Algae and vascular aquaticplants Terrestrial invertebrates Consistent with the process described in the Overview Document (EPA 2004), this risk assessment uses a surrogate species approach in its evaluation of spirotetramat. Toxicologicaldata generatedhorn surrogate test species, which are intended to be representative of the broad taxonomic groups mentioned above, are used to extrapolate to potential effects on a variety of species (receptors) included under these taxonomic groupings. Acute and chronic toxicity data from studies submittedby pesticide registrants along with the available open literature are used to evaluate the potential direct effects of spirotetramat to the aquatic and terrestrial receptors identified in this section. This includes toxicity data on the technical grade active ingredient, degradates, and when available, formulated products (e.g. "Six-Pack" studies). The open literature studies are identifiedthrough EPA's ECOTOX database (-, 

### which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of spirotetramat on biotic communities from loss of species that are sensitive to the chemical and from changes in structure and functional characteristicsof the affected communities. Table 

### 11.2 provides a summary of the taxonomic groups and the surrogate species tested to help understandpotential acute ecological effects ofpesticides to these non-target taxonomic groups. In addition,the table provides a preliminary overview of the potential acute toxicity of spirotetramatby providing the acute toxicity classifications. Acute toxicity classifications are based on the scheme outlined in Appendix I.

Page 

### 15 of 120 Bobwhite quail (Colinusvirginianus) Mammals Insects Freshwater fish2 Laboratoryrat (Rattusnowegicus) Honey bee (Apismellz~era L.) Bluegill sunfish (Lepomismacrochirus) Rainbow trout (Oncorhynchusmykiss) 

### Carp (Cyprinuscarpio) Practicallynon-toxic Practicallynon-toxic

Moderately toxica. Degradates Dicots- cucumber (Cucumis sativus, Not classified Cucurbitaceae),canola (Brassica napus,



### In addition to the acute data being available for all species listed in Table 11.2 for the parent spirotetramat, there were also some acutetoxicity data for the degradates. Overall, while the toxicity ofthe degradates to aquatic organisms appears to be equivalent to (for duckweed) or lower than that of the parent (all other instances), there is insufficient evidence for mammals, birds, gamasid mites, and earthwormsto reach the same conclusions. However, based on the currently available data, the overall toxicity of both the parent and degradates to these terrestrial organisms appears to be low. Aquatic plants and algae

Terrestrial invertebrates

Regarding the availability of data specifically for the degradates and aquatic organisms,there were acute toxicity data for spirotetramat-en01and 4-methoxycyclohexanone on rainbow trout (for en01only; practically non-toxic), zebra fish (for methoxycyclohexanone only; practically non-toxic), water fleas (practicallynon-toxic for both), midges (slightly toxic for enol, practicallynon-toxic for methoxycyclohexanone), green algae, and duckweed (enol only).- For 

### spirotetramat-ketohydroxyand 4- Page 16 of 

### 120 Birds represent surrogates for terrestrial-phase amphibians and reptiles. 2 Freshwater fish may be surrogates for aquatic-phaseamphibians.

Four species of two families of monocots, ofwhich one is corn; six species of at least four dicot families,ofwhich one is soybeans. Brassicaceae), soybean (Glycinema.), sunflower (Helianthus annuus L., Asteraceae), sugarbeet (Beta vulgaris, Chenopodiaceae), tomato (Lycopersiconesculentum, Solanaceae) Duckweed (Lemna gibba) Green algae (Pseudokirchneriella subcapitata) Freshwater diatom (Navicular pellicullosa) Blue-greenalgae (AnabaenaJlos-aqua) Marine diatom (Skeletonema costatum) Honey bee (Apis mellifera) Predatorymite (Typhlodromuspyri) Parasitic wasp (Aphidius rhopalosiphi) Green lacewing (Chrysoperla carnea) Ladybird beetle (Coccinella septempunctata) Earthworn (Eisenia fetida) Not Classified Practically non-toxic Not classified Not classified Not classified Not classified Not classified

### methoxycyclohexylamino carboxylic acid, there were acute toxicity data on midges demonstratingthat both can be classified as practically non-toxic to these organisms. For terrestrialorganisms, there were acute oral toxicity data on rats for spirotetramat-ketohydroxy, spirotetramat-desmethyl-ketohydroxy, spirotetetramat-di-hydroxy,and 

### spiroetetramat-mono-hyroxy demonstrating that all can be classified as practicallynon-toxic to these organisms. Lastly, toxicity data for earthworms using spirotetramat-ketohydroxy, spirotetramat-enol,and 4-methoxycyclohexanone, and gamasid mites using spirotetramat-enol, suggestthe overall toxicity to these organisms is low. b. 

### Formulations 

### In additionto acute toxicity data for the parent and degradates, there were also acutetoxicity data available on BY1 

### 08830 150 OD and Movento 240 SC in some instances. Onlythe data available for BY1 

### 08830 150 OD was formally reviewed by the Austrian Agency for Health and Food Safety (AGES) prior to this assessment. However, a cursory review of the data by US EPA reviewers suggest that generallythe toxicity of the parent and two products for which data were available are equivalent, and there is little concern at this time for enhanced toxicity of formulations. Therefore, the most sensitive endpoints, regardless of whether for the technical grade or the formulations,will be considered for use in this assessment for deriving risk estimates. Unless the studieswere found to contain the most sensitive endpoint available for a given taxonomic group based on a cursoryEFED review, or they had been reviewed previously by AGES, their details are not discussed within the body of this assessment. Specifically, for the formulationsBY1 

### 08830 150 OD and Movento 240 SC, 

### acute toxicity data were available for rainbow trout (moderately toxic), midges (highly toxic for 150 OD and moderately toxic for 240 SC), and green algae. There were also acute oral toxicity data on rats for both formulationsthat demonstrate they can be classified as practically non-toxic. For bees, there are acute toxicity data on both of the formulations that demonstratethe technical grade active ingredient and the formulated spirotetramat can both be classified as practically non-toxic. In addition, for BY1 

### 08830 150 OD and Movento 240 SC, there are a number of feeding trials and field studies with honeybees, and a number of acute toxicity studies with other non-target terrestrial arthropods (including green lacewings, ladybird beetles, parasitoid wasps, and predatory mites) that demonstrate a wide range in magnitude of acute effects.

c. Chronic There were no chronic data available on the formulations, and only limited chronic data available for the degradates; one studywith earthworms (4-8 weeks), one with gamasid mites (28 days), and a testicularlsperm toxicity studywith rats, all using spirotetramat-enol. A decrease in the mean number of juveniles was observed in the earthwonn study, increased mortality of parents was observed in the gamasid mite study, and testicularlspermtoxicity was observed in the rat study. In a 2-generation reproduction study with rats, decreased body weight and body weight gain during lactation was observed in both generations, while abnormal sperm cells and decreased reproductive performance was observed in the male parents. Some of the observed effects in the avian reproduction studies include (but are not limited to) a reduction in hatchling body weight, # 

### of 14-day survivors, # 

### of viable 14-day embryos, # 

### of live embryos, and # 

### of eggs hatched. Lastly, decreased fi-y 

### survival in the early-life stage studywith fathead minnows, decreased emergence and developmentalrate in the 28-day
Page 17 of 

### 120

### spiked-water study with midges, and decreased reproduction and weight and length ofparents in the lifecycle studywith water fleas were all chronic/reproductiveeffects observed in the available studies. 2. 

### Ecosystems Potentially at Risk 

### The ecosystems at risk are often extensive in scope, and as a result it may not be possible to identify specific ecosystems during the developmentof a baseline risk assessment. 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 cultivatedfields, fencerows and hedgerows, meadows, fallow fieldsor grasslands, woodlands, riparian habitats and otheruncultivated areas. Aquatic ecosystems potentially at risk 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. 

### D. AssessmentEndpoints 

### Assessment endpointsrepresent the actual environmental value that is to be protected, defined by an ecological entity (species, community,or other entity) and its attribute or characteristics (EPA, 1998). For spirotetramat, the ecological entities may include the following: birds, mammals, freshwater fish and invertebrates, estuarinelmarine fish and invertebrates, terrestrial plants, terrestrial non-target arthropods, and aquatic plants and algae. The attributes for each of these entities may include growth, reproduction, and survival. (See Table II.3 

### in SectionII.P.2, 

### the "Analysis Plan", for further discussion.) E. ConceptualModel 

### For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An 

### exposurepathway is the mewsby which a pesticide 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 feasible route of exposure. A conceptualmodel provides a written description and visual representation of the predicted relationships between spirotetramat, potential routes of exposure, and the predicted effects for the assessment endpoint. A conceptualmodel consists of two major components: risk hypothesis and a conceptual diagram (EPA, 1998).

Page 18 

### of 120

### 1. Risk Hypothesis For spirotetramat,the following ecological risk hypothesis is being employed for this baseline risk assessment: Spirotetrarnat (and its residues: spirotetramat-enoland spirotetramat-ketohydroxy), 

### when used in accordance with the label, results inpotential adverse effects upon the survival, growth, and reproduction ofnon-target terrestrialand aquatic organisms. Given the persistence and mobility ofspirotetrarnat and/ or its residues, there is a likelihood ofexposure to terrestrial and/ or aquatic organisms. 2. 

### Conceptual Diagram The conceptual model is a generic graphic depiction of the risk hypothesis. The conceptual model for spirotetramat assumes that as a systemic broad spectrumtetramic acid insecticide (ketoenole)that is a lipid biosynthesis inhibitor capable of translocation within plants following infiltration of leaves and root systems (xylem and phloem mobile), it may be capable of affecting terrestrial and aquatic animals and plants, provided that environmental concentrationsare sufficiently elevated as a result ofproposed label uses. Through a preliminary iterative process of examining available data, the conceptual model (i.e., the representation of the risk hypothesis) has been refined to reflect the likely exposure pathways and the organisms that are most relevant and applicable to this assessment (Figure 11.1). 

### It includes the potential pesticide or stressor, the sources and/ or transportpathways, exposure media, exposure points, biological receptor types, and attributechanges. Although both spirotetrarnat-en01and spirotetramat-ketohydroxy 

### appear to be less toxic than parent based on acute toxicity testing with aquatic receptors despite retaining the basic backbone structure of the parent, this assessment conservatively assumed equivalent toxicity among them and treated the two transformation products as well as the parent as potential stressors.The potential presence of these major metabolites was accounted for because they may be of concern in soils, sediments, and water due to their high concentrations in the laboratory studies (spirotetramat-enol) and their persistence relative to the parent (spirotetramat-ketohydroxy). 

### The potential sources and mechanisms ofrelease of these stressors as a spray include conventional ground sprayers, airblast equipment, rotary wing aircrafts, or sprinkler-type chemigation methods. Therefore, for both aquatic and terrestrial ecosystems, one major transport pathway is direct deposition of spray on-site or spraydrift 

### to off-target adjacent sites. Once deposited, terrestrial food items could be contaminated and available for consumption by terrestrial organisms. Therefore, ingestion of food items contaminated via spray

### drift is the route of exposure ofprimary concern in this assessment for terrestrial animalreceptors. Although accumulation from soil to plants or animal food sources, inhalation of vapor phase pesticide, and dermal exposure (contact with deposited residues and impingement of spray droplets) are not considered in this risk assessment, the very low octanoVwaterpartitioning coefficient,the low likelihood of volatilization of spirotetramat from soil or water based on a low vapor pressure and Henry's Law constant, the rat acute inhalationLCso(>4.183 mg/L), and the low dermal acute toxicity of the parent in the rat (LDS0 >2000 mgkg-bw), all suggestthat these routes of exposure arenot likely to be significant for terrestrial organisms. Other routes of exposure for terrestrial wildlife that are possible but not considered in this risk assessment include drinking water exposure, inhalation ofpesticide associatedwith suspended soil particulate, inhalation of spray droplets, and oral ingestion of soil particles through incidental contact while Page 

### 19 of 120

### feeding and preening. 

### In addition to spray drift, given their moderate to high solubility, relatively low level of binding, and low tendency to bioaccumulate/bioconcentrate,

### these stressors are considered moderately to highlymobile and couldbe potentiallytransported to adjacent terrestrial areas, wetlands, or bodies of water via surface runoff from rain events. Thus, for aquatic receptors, the major point of exposure is through direct contact with the water column, sediment, and pore water (gill/ integument) contaminatedwith spray driR and/ or runoff from treated areas. Food chain exposures are not considered to be significant for this pesticide because spirotetramathas a low l-octanoVwater partition coefficient. Lastly, potential points of exposure for terrestrial or semi-aquatic plant receptors may include direct contactvia spray drift or through root uptake of spirotetramat in soil or water. However, while the potential for root uptake is possible given the systemic nature of spirotetramat, the potential for cumulativeeffects to plants resulting fi-omcombined routes of exposure including root uptake could not be evaluated and are unclear due to the limitations of current guideline studies.
Figure 11.1. Ecological ConceptualModel for Screening-LevelRisk Assessment of Spirotetramat Applied to Agricultural Fields 

# I Spirotetramat total residues (spirotetramat, spirotetramat-enol, and spirotetramatketohvdroxv) aoolied as aroundlaerial sorav toan aaricultural field 

# I Source1 Transport Pathways Exposure 

## -----v- 

### ---- I"OIatilization 

## / , ---- -t

## --

## --- I Leaching 

## i ! /Wind ! De~osition Erosion ! (Infiltration1 I 

### [ Suspension I 

### ----------- Residues (foliage, 

## i Percolation 

### j ----- 

### , ----

### -I:::, Upland 

# &Am*

FoliagelSoil 

### ----------- Groundwater 

### ; 

## I FoliageISoil Exposure Point 4 

# + + Ingestion Direct contact/ Direct contact1 GilV Integument 

## I Root Uptake Root Uptake Uptake
TerrestrialVertebrates Receptors & Invertebrates Birds, Small Mammals, Reptiles, Terrestrial
Attribute IndividualAnimals Changes Reduced survival Reduced growth Reduced reproductior Amphibians

Plant Po~ulation Reducedsurvival invertebrates Reduced SUNN~~ Reduced growth Reduced reproduction Bioaccumulation *Dotted lines are usedto signify exposure pathways that are not expectedto be appreciable for spirderamat.

Page 20 of 120

### F. Analysis Plan 1. 

### Preliminary Identification of Data Gaps and Analysis Plan The primary method used to assess risk in this screening level assessment is the risk quotient (RQ) and follows closelymethods outlined in the EPA Overview Document (EPA, 2004). The RQ is the primary risk value for the screening level assessment and is the result of dividingthe measures of exposure (estimated exposure concentration; EEC) by the measures of effect (most sensitive acute and chronic toxicity values for each taxonomic group). The resulting RQs are then compared to the Agency's levels of concern (LOCs). These predetermined LOCs are the Agency's interpretive policy and are used to indicate when a pesticide's use as directed on the label has the potential to cause adverse effects on non-target organisms and when regulatory action may need to be considered. Although risk is often defmed as the likelihood and magnitude of adverse ecological effect, the RQ method does not provide an estimated probability of effect andlor magnitude of an adverse effect. However, in general, the higher the RQ, the more certain the potential risks. If RQs exceed the LOCs, the Agency presumes potential for risk to the taxa. Risk presumptions, along with the correspondingRQs, equations, and LOCs are summarized in 

### Appendix E. Generation of robust RQs is dependent on the quality of data from both fate and toxicological studies. 

### In agreement with international governmental partners associated with registration efforts for this pesticide, ecological fate and effects data evaluation and approval responsibilities are being met through the efforts of 

### the Austrian Agency for Health and Food Safety (AGES). Data gaps and associated uncertainties for spirotetramat were previously identified in sections 1.F.land I.F.2 of the "Executive Summary" portion of the chapter. 2. 

### Measures of Exposure and Effects Assessment endpoints, the actual environmental values that are to be protected, require one or more measures of ecological effects, which are measurable changes in the attribute of an assessment endpoint in response to a stressor. It also requires measures of exposure, which are the measures of stressor existence and movement in the environment and their contact or co-occurrence with the assessment endpoint. A brief description of the tools and methods used to generate measures of exposure are described below, and a description of the ecological toxicity data from which measures of effects were derived are presented in the "Effects Characterization" section of the assessment. A summary of the assessment endpoints and their respectivemeasures of exposure and effects for spirotetramatare listed in 

### Table 11.3. For agricultural uses, exposure concentrations for aquatic ecosystems assessmentswere estimated based on EFED's Tier 2 aquatic model PRZMIEXAMS. A graphical user interface (PE5), developedby the EPA 

### <http://www.epa.gov/ovvefedl/models/water>, was used to facilitate inputting chemical and use specific parameters into the appropriate PRZM input files (inp) and EXAMS chemical files. This approach employs PRZM, which simulatesthe processes in the agricultural field, such as runoff and erosion, on a daily time step. The runoff and erosion flux output data from PRZM are used as chemical loadings to EXAMS, which simulates surface water in order to predict the EECs. Eight PRZM field (crop) scenarios were modeled: 

### FL citrus,NYgrapes, NC apples, MI cherries, CA almonds, 

### OR Christmas trees,PA tomatoes andIDpotatoes. 

### An effort was made to cover all areas of the continental United States and to select a variety of crops with the highest application rates. EECs for ecological risk assessment were determined using a pond modeling scenario which describes a generic scenario for the EXAMS component
Page 21 of 120

### of the modeling exercise. The results from PRZMIEXAMS runs and the details on the models appear in the Appendix 

### B. Measures of exposure for terrestrial mammals, birds, reptiles and amphibians incorporate maximum proposed use rates but rely less on fate properties. Acute and chronic terrestrial exposure estimates are derived directlyfrom empirically determined observationsofpesticide residues on various terrestrial food items. The Kenaganomogram, as modified by Fletcher et al., (Kenaga and Hoerger, 1972; Fletcher et al., 1994) is used to relatepesticide application rates to residues on terrestrial food items. The surfaceresidue concentration (ppm) is estimatedby multiplying the applicationrate (pounds active ingredient per acre) by a value specific to each food item. For numerous applications for a given use, the exposure model incorporatesa first-order decayrate dependent on the foliar dissipation half-life of the chemical. The conceptualapproach taken to estimate residues (upper-bound and mean) in potential dietary sources for mammals and birds is presented in the model T-REX (T-REX, Version 1.3.1, dated December 7,2006) For more details see "Exposure Characterization" section of this document. Exposureto terrestrial plants is estimated using the TerrPlant (v1.2.2) Tier 1 screeningmodel. TerrPlant estimates potential exposure of non-listed and listed species of monocots and dicots inhabiting dry (upland) and semi-aquatic areas (wetland) which are adjacent to treatment sites. The model doesnot consider exposures to plants from multiple pesticide applications, but rather, only from a single application using default assumptions for runoff and spray drift. 

### For more details see the "Exposure Characterization" section of this document.

Page 22 

### of 120

### III. Analysis vascular)

A. Use Characterization vascular) ECS0 and NOAEC values for growth rate and biomass measurements

Spirotetramatis a new pesticide against chewing insects. It may be applied a minimum of 2-3 times at the maximum application rate of 0.08-0.16 lb a.i./A, and a maximum seasonal application rate of 0.16-0.40 lb a.i./A. According to the proposed label, the minimum intervalbetween applicationsis 7-30 days, and the '~~50 =Lethal dose to 50% ofthe test population;NOAEC =No observed adverse effect concentration;LOAEC =Lowest observed adverseeffect concentration; = Lethal concentration to 50% of the test population;EC5dEC25 = Effect concentration to 50Yd25% ofthe test population. 2~irds represent surrogates for amphibians (terrestrialphase) and reptiles. Freshwater fish may be surrogates for amphibians (aquatic phase). One in 10-yearreturn tkequency. Four speciesof two families ofmonocots 

### - one is corn, six species of at least four dicot families, ofwhich one is soybeans.

Page 23 

### of 

### 120

### pre-harvest interval (PHI) ranges from 1-7 

### days. A summarytable of 

### all new use patterns is provided 

### in Table III.1.

Page 24 of 

### 120 grapeht,kumquat, lemon, he, mandann or tangelo, sweet and sour orange,

Grape and Small Fruit Vine Climbing (except lawht)(mcludmgAmencan bunch grape, muscadme grape and Weragrape) Pome Fruit (Crop Group 11, mcludmg apple, crabapple, loquat, mayhaw, pear, oriental pear, qmce) StoneFruit (Crop Group 12, mcludmg apncot, sweet and tart cherry, nectarine, peach, plum-vanous hds,plumcot and fiesh and driedprune) Tree Nuts (Crop Group 14 plus p~tacluo, mcludmg almond,beechnut, Brazll nut, butternut, cashew, chestnut, chquapm, filbert-hazelnut, luckory nut, macadarmanutbush nut, pecan, pistacho, walnut-black and Enghsh) Hops
Christmas Trees 0 12

0.14

0.14

0.14

0.10
0.16 2

3

2

3

2
2 0.2

0.4

0.24

0.34

0 2
0.32 30

7

14

14

14
14 G*, A, Airblast

G*, A, Airblast
G*, A, Airblast

G*, A, Airblast

G*, A Airblast G*,A, Airblast 7

7

7

7

7
NIAPage 25 of 

### 120 Cucurbit Vegetables [Crop Group 9, includmg chayote, Chinesewaxgourd-Chinese preserving melon, citron melon, cucumber, gherkin, gourd-variouskinds, Momordica spp.-includes various kinds, muskmelon (various kinds like cantaloupe, casaba, Crenshawmelon, melon, honeydew melon, Persianmelon, pineapple melon, snake melon, and others), pumpkin, squash (includes summer type squash like scallop squash zucchini and others, and winter type squashlike acorn squash calabaza and others), and watermelon (includes hybrids)] Fruiting Vegetables (Crop Group 8plus okra including eggplant, groundclieny, okra, pepinos, pepper-variouskinds, tomatill0 and tomato) Leafy Vegetables (Crop Group 4 including amaranthvarious kinds, arugularoquette, cardoon, celery, celtuce, chervil Chinese celery, chrysanthemum,cornsalad, garden cress, cressvarious kinds, dandelion, sorrel dock, endive, Florence fennel, lettuce-head and leaf, orach, parsley, garden and winter purslane, radicchio-redchicory, rhubarb, spinachvarious kinds, Swiss chard) Brassica (Cole) Leafy Vegetables (Crop Group 5 including broccoli raab, Brussels sprouts, cabbage, cauliflower, cavalobroccolo, Chinesebroccoli, Chinese cabbage, Chinesemustard cabbage, collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, rape greens, turnip greens) 0.08

0.08

0.08

0.08 2

2

2

2 0.16

0.16+

0.16+

0.16+ 7

7

7

7 G,A, Chemigation **

G, A, Chemigation

G, A, Chemigation * *

G,A, Chemigation ** 1

1

3

1arracacha, arrowroot, artichoke-Chineseand Jerusalem, edible canna, bitter and sweet cassava, chayoteroot, chufa, dasheen-taro, otato tanier turmeric



### Spirotetramat may be applied via conventional ground sprayers (conventional, high air velocity, low volume or air curtain sprayers); airblast equipment; rotary wing aircraft; or sprinkler-type chemigation methods (center pivot, lateral move, sideroll, or overhead solid set irrigation systems only). The proposed label does not have a designated buffer zone. Some of the crops that may have multiple seasons per year include leafy, brassica, and fruiting vegetables in CA, AZ, 

### FL, GA, LA, NC, TX, andlor SC; for these crops, the applicationrate per year may be higher than the maximum seasonal applicationrate. The registrant recommends that spirotetramatmay be applied alone or tank-mixed with another Group 23 insecticide(that is, with mode of action of lipid biosynthesisinhibition or LBI), in a block rotation with products from other chemical classes with a different mode of action in order to prevent insect's resistance. The labelsrecommend that spirotetramat's products shouldbe tank-mixed with a spray adjuvant/ additive that may have spreading and penetrating properties to increasethe leaf uptake and systemic nature of the active ingredient within the plants. Nonetheless, it is indicated that sufficient leaf tissue should be present for uptake and translocation to occur. For that reason, applicationsprior to petal-fall on pome hits, stone fruits and tree nut crops are not recommended. For runoffmanagement, it is indicated that the product may contaminatewater through runoff or drift of spray in wind. Poorly draining soils and soils with shallow water tables are indicated to be more prone to produce runoff that contains the product. There is the advice that a level well maintained vegetative buffer strip between areas to which the product is applied and surfacewater bodies such like ponds, streams and springs will reduce the potential for contamination of water from rainfall runoff. It is noted, though, that such buffer strip is not mandatory. Also, the label instructs to avoid applicationswhen rainfall is forecasted

### to occur within 48 

### hours following application. The following are other measures to avoid spray drift, as stated in the proposed label: 1) 

### Select nozzles and pressure that deliver medium spray droplets as indicated in nozzle manufacturer's catalogs and in accordancewith,ASAE Standard S-572. Nozzles that deliver coarse spray droplets may be used to reduce spray drift provided spray volume per acre (GPA) is increased to maintain crop coverage. 2) Applications Page 26 of 

### 120

### more than 10

### feet above the crop canopy shouldbe avoided. 

### 3) Avoid spraying during conditions of low humidity and/ or high temperature (may increase the evaporationrate of spray droplets). 4) Do not apply when winds are greater than 

### 15mph and avoid gusty and windless conditions. 5) Avoid applications when wind direction is toward an aquatic area (can reduce risk exposureto sensitive aquatic areas). 6) 

### Do not make an aerial or ground application during temperature inversions. The proposed label also contains an endangered species advisory: "The use of any pesticide in a manner that may kill or otherwise harm endangered species or adverselymodify their habitat is a violation of Federal law." B. Exposure Characterization 

### 1. Environmental Fate and Transport Characterization 

### For detailed environmental fate and transport information,refer to the Volume 3, 

### Annex B.8: Fate and Behaviour in 

### the Environment, attached in Appendix A. 

### Two stereo isomers of spirotetramat, cis- and trans-isomer, are possible. The cis-isomer is the active substance. The cis-/trans-isomer ratio is about 98:2.

Table 111.3 

### summarizesphysicall chemical and environmentalfate/transport properties of spirotetramat (and transformation products). 373.45

;acetone = 100-120 WAC: cis-3-(2,5-dimethylpheny1)-8-methoxy-2- oxo-l-azaspiro[4.5]dec-3-en-4-yl ethyl carbonate Cb: Carbonicacid, cis-3-(2,5-dimethylpheny1)-8- methoxy-2- oxo-l-azaspiro[4.5]dec-3-en-4-yl ethyl ester

Page 27 

### of 120HLC at 20°C and pH 7, estimated from VP

[pH 4,7,9;(20 and25 "C)] Majormetabolite -spirotetramat-enol.

olutim andnatural water.

DTgo for enol= 0.17,0.07,0.53and 0.06 Respective DT90 for ketohydroxy- 55.6, 13.9, 16.9and 5.1 days. Respective DT9o for MA-amide= 18.1,3.6,

OMC=first order multi-compartment
SFO=single first order kinetics. Page 28 of 

### 120Aerobic Aquatic Metabolism *RespectivespirotetramatDT90's = 3.52 **Respectivespirotetramat-enol DT9,,'s =

Organic Carbon Partition

27,65,29 and 99; mean &= 55 mL/goc

Mean = 1.067 mUg 43.1,48.1,42.0,99.7, 93.7mUgoc Mean = 65.3 dgoc

Half-life for parent spirotetramat SFO=single first order kinetics.or SF0 in

a. Summary 

### of Empirical Data All the following appear to be important routes of degradation/transformation for spirotetramat: hydrolysis in alkaline media, photolysis 

### in natural water and biodegradation 

### in aerobic and anaerobic environments (half-dissipation times or DTS09s range 

### <1-2.8 days). Hydrolysis in neutral and acidic environments and Page 29 of 120photolysis in sterilebuffered solution (half-lives 8.6-32.5 days) appear to be routes of transformation of lower importance for spirotetramat. The chemical degrades to spirotetramat-en01(product of cleavage of the ester link), which fiuther degrades relatively rapidly in aerobic soil environments and under photolytic conditions, and subsequently forms numerous degradatesmost of which have the basic backbone structure of spirotetramat. Spirotetramat-en01is more persistent in aquatic environments and relatively stable in anaerobic media. Spirotetramat's total residues of concern (spirotetramat

## + spirotetramat-en01

### + spirotetramat-ketohydroxy, and the non-extracted residues) are more persistent than the parent and have a potential to contaminate surface waters for a period of weeks to months posttreatment (via surface water runoff or runoff accompanied with erosion), and some potential to move subsurface and contaminate groundwater 

### in vulnerable sites. Field dissipation studies confmthe findings of the laboratory studies, with spirotetramat dissipating with DTS09s in the range of 0.3-1.0 days, and total residues of spirotetramat

## + spirotetramat-en01

## + spirotetramat-ketohydroxydissipating much more slowly. Given the moderate to high solubility of spirotetramat, spirotetramat-en01and spirotetramat-ketohydroxy, and their relatively low level of binding (relativelylow partition coefficients,G7s and Gc7s), and low affinity to organic matter (l-octanoV water partition coefficient or Kow'sf 324 for all three compounds), these particular chemicals could be released via plant wash-off to soils in rain events, especially if they occur shortlyafter application. When applied, spirotetramat andl or its residues may be translocated into the targeted crop/ canopy (leaves and shoots), they may also be taken up through the roots. There is also the chance that the parent would be deposited off-targetby spray &iff (the chemical may be applied by ground and aerial methods or via airblast). It appears that the residues could reach adjacent bodies of water 

### in runoff eventsboth via dissolution or bound to the soils (high levels of non-extractedresidues were observed in most laboratory studies). 

### b. General Spirotetramathas a moderate solubilityin distilled water (33.4 mg/L in water at pH 6.0-6.3, and 29.9 mg/L in buffered solution at pH 7 at 20°C) and a high solubilityin various common organic solvents (e.g. ethanol, toluene and acetone). Spirotetramat's low vapor pressure and Henry's Law constant (4.2~10-" 

### mm Hg and 6.90~10-l3 ~tm-m3/mol, respectively, at 20°C and pH 7) indicatesthat it is not likely to volatilize substantially. Spirotetramat's 1 -octanol/water partition coefficient O(ow) is 324, indicating a low tendency to bioaccumulate/bioconcentrate. For spirotetramat-enol, a major transformation product of spirotetramat, the water solubility is much higher than the one for spirotetramat (2,700 mg/L at pH 

### 7) and the 1-octanollwater partition coefficient is also low (2.1 at pH 7). For 

### spirotetramat-ketohydroxy,the water solubility is also higher than for spirotetramat (228 mg/L), and the 1 -octanoVwater partition coefficient is low (20 at pH 7). These relatively high solubilitiesin water, coupled with the low octanoll water partition coefficients suggestthat these transformation products have a low tendency to bioconcentratelbioaccumulate and do not partition highly with organic matter.
c. Degradation Hydrolysis is relevant for the overall degradation1dissipation of spirotetramat in aquatic systems, especially in neutral to alkaline conditions. Thehydrolysis behavior of spirotetramat depends on the temperature and pH. The rate of reaction increased with increasing temperature and pH. At 25OC, the experimentalhalf-lives for the chemical were 32.5, 8.6 and 0.32 days at pH's of 4, 7 and 9, respectively. The major hydrolysate is spirotetramat-enol, which appeared to be stable to hydrolysis in this and in a separate study conducted on the metabolite at pH's 4, 7 and 9 and 50°C for 5 days. Spirotetramat photolyzes relatively rapidly in sterile natural water. Spirotetrarnatphotolyzes with Page 30 

### of 120hydrolysis-corrected half-lives of 3.0 and 0.22 days, in sterile buffer 

### (pH 5) solution and sterile natural water 

### (pH 7.9), respectively. These half-lives correspondto 14.4 and 0.74 days, respectively,under environmental conditions of summer light in Phoenix, 

### AZ. In sterilized natural water the major products observed were spirotetramat-en01(maximum 81.9% of the applied radioactivity or AR at 1 day), methoxycyclohexanone (maximum 17.5% of AR at 8 days) and methoxy-cyclohexylamino carboxylic acid (maximum 11.3% of 

### AR at 10days). In sterile buffer solution (pH 5), the major transformation products were 

### spirotetramat-photo-cyclopentyl (maximum 42.9% at 7 days), 

### spirotetramat-photo-2-hydroxymethyl (maximum 22.9% of 

### AR at 6 days), 

### spirotetramat-photo-2-formyl(maximum 11.5% of AR at 

### 3 days) and 

### spirotetramat-photo-2-methylcarbonate (maximum 19.3% of AR at 6 days). All the latter metabolites are the result of rearrangement of the parent. Both these studies show that aqueous photolysis can be an important route for the degradation of spirotetramatfrom the environment. The soilphotodegradation study available on spirotetramatwas found to have certain deficiencies and definite conclusions on the rate of soil photodegradationcould not be derived from it. However, some useful information on the identity of the degradates in the studymay be obtained from it. The following degradates were identified (34.8%): spirotetramat-enol, 

### spirotetramat-ketohydroxy, methoxycyclohexanone and dimethylbenzoic acid. Methoxycyclohexanoneand dimethylbenzoic acid were observed only in the irradiated samples. 

### d. Metabolism and TransformationProducts Spirotetramat degraded under aerobic conditions relatively quickly, with calculated half-dissipation times (DTS07s) of <l day in three soils from the EU and one domestic SL soil (range 0.09-0.30 days). Furthermore, spirotetrarnat-en01also degraded relatively quickly, with DT507s of <l day, in three soils from the 

### EU and one domestic SL soil in a separate study conductedwith the metabolite (range 0.02-0.16 days). 

### In the course of the spirotetramat-en01degradation study, spirotetramat-en01showed a biphasic kinetic behavior with >80% of AR degradedby day 1 posttreatment and slower degradation from 1 to 119 days after treatment or DAT (from 10.7 - 17.2% ofthe applied radioactivityor 

### AR to 2.7 - 6.1% of 

### AR). DTS03~ forspirotetramat-ketohydroxy(maximum 24.0% of 

### AR at 1 day) were derived from the results obtained 

### in the study conducted on spirotetramat-en01(range of DTSo7s 1.5-16.7 days). Also, DTS07s for spirotetramat-MA-amide(maximum 5.2% of 

### AR at 1 day, a minor metabolite)were derived from the results obtained in the studyconducted on spirotetramat-en01(range of DTSO's 0.3-5.4 days). Carbon dioxide formation was 9.7-19.4% by 50 days in the study conductedwith spirotetramatand 10.9- 34.9% by 60 days in the study conducted with spirotetramat-en01(four soils in both cases). Volatile organicswere insignificant while non-extracted residues were important (both cases). 

### In the parent study, using an acidic extraction method, the non-extracted residues increased, reaching a concentration in the range of 22-35% of AR by 

### 1to 3 DAT, with no decreasethereafter. 

### In the studyconducted on spirotetramat-enol,using a slightly alkaline extractionprocedure, non-extracted residues increased to reach levels of -40-60% of AR by 1 

### DAT, with no significant decreasethereafter. Fractionation of the nonextractedresidues showed a heterogeneous composition, with a high portion of hlvic acids in both studies. 

### In an outdoor metabolism study spirotetramatdegraded with calculated half dissipation times (DTS0's) of 1.2 and 2.9 days. Spirotetramat-en01was a maximum of 7.8%. The degradates spirotetramat-glyoxylic amide and dimethyl-benzoic acid were observed besides the aerobic soil metabolites. The latter two compoundswere also observed in the supplemental photodegradationon soil study, which provided limited data. The levels of non-extracted residues were lower 

### in the aerobic outdoors study (compared to the two aerobic soil metabolism studies, conducted on the parent and spirotetramat-enol) with 516.8% of the AR. 

### Figure 111.1 provides the proposed degradation pathway for spirotetramat, including all the transformation products (major and minor). Page 31 of 120

### In aquatic environment, under aerobic aquatic conditions, spirotetramat degraded with calculated DTSO9s of -1 day in the total system. Spirotetramatwas mostly associatedwith the aqueous phase. The metabolite spirotetramat-en01 reached a maximum at 14 days at 99.0%, and decreased to <LOQ to 21.0% at 120 days. The degradate spirotetramat-ketohydroxywas a maximum of 50.8% at study termination. DTS03s for spirotetramat-en01were derived from the studyresults (range of DTSo's 37.9-59.0 days). Minor transformation products were 

### 58.7% in total system. Non-extracted residues increased throughout the study to a maximum of 33.9% at 120 days. Mineralizationwas a maximum of 13.5-24.0% at 120 days. In the anaerobic soil metabolism study, the metabolites observed were also generally consistent with the ones for the aerobic soil metabolism studies for spirotetramat and spirotetramat-enol. Under anaerobic soil conditions, spirotetramat degraded quickly with a calculated half-life <<I day. The major degradates were spirotetrarnat-enol, which increased throughout the study (maximum 54.6% at 180 days) and spirotetramatketohydroxy (maximum 19.3% at 1 day). Mineralizationwas very low. Non-extractable residues were a maximum of 17.5% at 0.6 days. In an anaerobic aquatic metabolism system, spirotetramat completely degraded to spirotetramat-enol, which was found to be stable thereafter. The DTS0 for the transformation of spirotetramat was calculated to be 2.8 days in the total anaerobic system. 

### A summary of the major degradation products of spirotetramatis provided in 

### Table 111.4. 

### The structures of all the transformation products of spirotetramatare provided in 

### Table B.8-3 of the monograph (B8. Fate and behaviour). The monograph also contains additional information and details on fate and behavior. Major degradates observed in the laboratory studies were spirotetramat-enol, spirotetramat-ketohydroxy, dimethyl-benzoic acid, methoxy-cyclohexanone, 

### methoxy-cyclohexylaminocarboxylic acid, spirotetramatphoto-cyclopentyl, 

### spirotetramat-photo-2-methylcarbonate, spirotetramat-photo-2-hydroxymethyl, spirotetramat-photo-2-formyl. 

### Spirotetramat-en01and spirotetramat-ketohydroxy were observed under metabolism conditions, while the other metabolites were observed under photolytic conditions (on soil and/ or in water). The major degradation pathway for spirotetramat under aerobic soil condition is hydrolytic cleavage of the ester bond of spirotetramat, yielding spirotetramat-en01(presumed to be quantitative). The latter is oxidized at the benzylic carbon to spirotetramat-ketohydroxy(maximum 24.0% at 1 day in the aerobic soil metabolism study), which is hydrolytically opened to spirotetramat-MA-amide (maximum 5.2% at 1 day). In another possible pathway, demethylation of spirotetramat-en01occurs to yield spirotetramat-desmethylen01 and subsequentlyspirotetrarnat-0x0-en01(minor products). Furthermore, oxidative spirotetramat-en01 dimerization may occur to yield spirotetramat-en01dirner 1 and spirotetrarnat-en01 dimer 2. The degradation products in most soil and water1 sediment studieswere consistent with one or more of these degradation pathways. Information derived from the soil photodegradation allowed to obtain information on the presence of the degradates. In addition to the metabolitesmentioned above, dimethylbenzoic acid, spirotetramat-glyoxylic amide and methoxy cyclohexanone were observed in the soil photodegradation study. Two stereo isomers of spirotetramat, cis- and trans-isomer, arepossible. The cis-isomer is the active substance. The cis-/trans-isomer ratio is about 98:2. Spirotetramat-en01 keeps the cis-/trans-isomer ratio upon reaction, while 

### spirotetramat-ketohydroxy has one additional chiral center due to the presence of a hydroxyl group. The enantiomeric ratio for spirotetramat-ketohydroxy is 1:

### 1,while keeping the cis-/transisomer ratio. Instead of half-lives derived using the log-linear relationship, except where indicated, half-dissipation times (DTS07s), obtained from other kinetic models were used (e.g. single first order [SFO], double first Page 32 of 

### 120order in parallel [DFOP], single first order reverse binding [SFORB]and first order multi-compartment [FOMC]). These kinetic models defined the behaviour of the chemicals (e.g. spirotetramat-en01degraded with a biphasic behavior) and were used in agreement of the EPA with AGES and PMRA. 

### ' Table 111.3 details the kinetic models selected for spirotetramat and its transformation products.

e. Soil Sorption,Mobility and Transport Spirotetramat is moderately mobile in five sterilized soils, with 

### &values ranging from 3.58-5.52 mLIg, Koc values between 184-437 dgoc (mean 289 mLlgoc), 

### KF values ranging from 3.70-4.79 (pglgoc)/(pg/m~)lln, KFoC values ranging from 159-435 (pglgoc)l(C1gl)lln [mean 28 1 (pg/goc)/(pg/mL)lln], and lln values close to unity, ranging from 0.823 to 1.042 (mean 0.941). The degradates spirotetramat-enol, 

### spirotetramat-ketohydroxy and spirotetramat-MA-amide were found to be more mobile than the parent, spirotetramat. There is the risk of offsite transport for these metabolites due to runoff. No definitive batch equilibrium test could be conducted on spirotetramat-en01 because the chemical was labile duringthe adsorptionphase. The mobility of spirotetramat-en01 was assessed using a soil column leaching study. The chemical was found mostly in the 0-6 cm soil depth (9.6-16.5%) and at lower levels in the 6-12 cm soil depth (0.1-1.4%). 

### In the leachatefractions, spirotetramat-en01was a total of 0.1-2.8%. The estimated 

### Gc values for spirotetramat-en01 were between 27-99 &goc (mean 55 mLlgoc) over four soil types (mobile), with 

### &values ranging from 0.52 to 0.86 mL1g. The degradate 

### spirotetramat-ketohydroxyis mobile in five sterilized soils, with 

### &values ranging from 0.529-2.28 rnL/g, 

### Gc values ranging from 43.1-99.7 mLlgoc (mean 65.3 mL/goc), KFvalues ranging from 0.516-2.21 (pglg)l(pg/m~)"n, KFoC values between 41.O-99.1 (pg/goc)/(pg/mL)lln [mean 63.7 (pg/goc)/(pglmL)'/"] and lln values close to unity (range 0.915-0.929, mean 0.922). The 

### Gc values were similar to the Freundlich adsorption constants KFOC. The degradate spirotetramat-MA-amide is mobile to highly mobile in five viable soils, with 

### &values ranging from 0.064-0.179 mL/g, Koc results ranging from 4.2-25.6 mL/goc (mean 9.6 &goc), 

### KFvalues ranging from 0.075-0.179 (pg~~)l(p~/m~)~~~, KFoC values 4.4-25.5 (~cg/~oc)l(p~/mL)~~~ [mean 9.3 (pglgoc)l (pglmL)'ln]and lln results from 0.80-1.07 (mean 0.95, for four of the five soils the range 0.93-1.07). A major route of exposureto spirotetramat to surfacewater environments will be from spray drift. Due to their low persistence in aerobic soils, spirotetramat and spirotetramat-en01generally shouldbe available for runoff only shortly after application to a few days after treatment. Nevertheless, spirotetramatketohydroxy, the terminal product, and the most persistent, may be available for runoff during rain events occurring from shortlyafter application to several weeks or months after application. Spirotetramatketohydroxy was observed in the laboratory at significant concentrations(maximum 24.0% of the AR in the aerobic soil metabolism study). Because of their low persistence in aerobic soils, spirotetramat and spirotetramat-en01are not expected to be important leachers (despitetheir mobility classification). It is noted, however, that spirotetramat-en01is persistent in anaerobic environments. 

### Spirotetramat-ketohydroxywas more persistent than the parent in aerobic soils. Vulnerable soils, with low pH's, and low microbial population could be at risk. f. Field Dissipation Spirotetramat, at approximately 0.4 lb a.i./A, formulated as an oil dispersion, was applied once to four plots (most of which included, both, bareground and planted, total of 7 trials), located in the USA (FL, CA, 

### NY and WA), dissipated rapidly with calculated half-dissipationtimes @T50'~) of 0.3-1.0 days (estimated for the residues of spirotetramat present in the 0-45 cm soil layer). These values are consistent with the Page 33 of 120

### ones observed in laboratory trials. No carryover from year to year is expected for spirotetramat. Due to the low storage stabilityof spirotetramat-enol,which degradedto spirotetramat-ketohydroxy during storage, accurate individualquantification of these metabolitesis not possible. Instead, the combined residues of spirotetramat-en01 and spirotetramat-ketohydroxy

### were calculated. Those residues presented calculated DT50'~ of 4.6-3 1.6 days (0-45 cm soil layer). In addition, the combined residues of spirotetrarnat, spirotetramat-en01 and spirotetramat-ketohydroxy

### were found to degrade at moderate rates with DTS09s ranging from 5.0-23.4 days (0-45 cm soil layer). Spirotetramat and its residues remained in the top 0-15 cm soil layer, except for detections in the 15-30 cm soil layer at the Florida site; the chemicals observed abovethe LOQ in 15-30 cm soil layer were spirotetramat-en01and spirotetramat-ketohydroxy

### at days 1 and 7. The residues went below the LOD and the LOQ by the next test interval.
g. Bioaccumulation 

### Spirotetramat's 1-octanol/water partition coefficient 

### (KO*) is 324, indicating a low tendency to bioaccumulate/ bioconcentrate. In addition, for spirotetramat-en01and spirotetramat-ketohydroxy their Kow

### are also low: 2.1 and 20, respectively, pointing towards a low tendencyto bioaccumulate/ bioconcentrate.

Page 34 of 

### 120

# 1 Hydrolysis (- 2 H) (3"' Oxidation Enol-dimer 1 Enol-dimer 2 Hydratization 

# - / OHO Dihydroxy Enol
Oxidation 

# -

Ketohydroxy- Ketohydroxy Desmethyl-enol carboxv 

# 1 Hydrolysis

H COOH 

# @$\ OCH,

CH3 MA-amideOxidation 

# \ Oxidatio

# 1

Oxidation Oxidatio

CH, 0 

## 1 COOH 

# 6 Molecule 

# Po \ Methoxy Molecule acid** 

# - cyclohexanone

### *** cleavage OCHs OCH3 CH3 CH3 Glyoxylic amide**

C02 Bound residues *: postulated intermediate; ** and *** were identified in studies including light (dependent on radiolabel used) Copied from Volume 3, Annex B8. Fate and Behaviour in the Environment Fig. 111.1. Proposed metabolic pathway for spirotetramat in soil.
Page 35 of 

### 120

### h. 

### Uncertainties and Issues Uncertaintiesand issues were discussed in SectionI.F.l, 

### a brief description follows. There is uncertainty about the role of soil photodegradationon the fate of spirotetramatand,or its transformation products. Results of the available study were deemed supplemental, providing limited data. From the study, the degradates, dimethyl-benzoic acid and methoxycyclohexanone were identified. A new photolysis on soil study, conducted on a sterile soil is in process. There is uncertainty with respect to one of the five soils used in the batch equilibrium study performed in the parent spirotetramat. It was conducted with a Saskatchewan, Canada loam soil. However, the soil taxonomic classification is uncertain. Thispart of the study is considered supplemental. The soil taxonomy for the 'Saskatoon' loam soil constitutes a data gap. Spirotetramat-enol's pKa is 5.2, which suggests that it may be ionizable at environmentally relevant pH's. Nonetheless, the ionization potential of spirotetramat-en01could affect the mobility of the chemical with the soilpH (at high pH's high concentrations of the "enolate" form of the chemical would occur and higher mobility is expected). In 

### the soil column leaching studies,the range ofpH's was 6.1-6.5 for three EU soils and it was 5.4 for the FL SL. There are no studies conducted at higher pH's. The presence of aqueous photolysates of sterile buffer solution in the environmentis uncertain, compared to the presence of aqueous photolysatesin natural water. In 

### sterile buffer solution 

### (pH 5), the four major transformation products were identified. These transformation products were not observed in the photolysis study conducted with sterile natural water. Various other minor degradates were observed in the laboratory studies. Spirotetramat-en01dimers 1 and 2, at up to 5.0 and 3.6% of AR, respectivelyin the aerobic soil metabolism study. It appears that their presence may be due to the called "hot spots" applicationmethod that was utilized 

### in the laboratory studies, where spirotetramatwas applied in acetonitrile at relatively high concentrations. It is speculated that spirotetramat was concentrated in "hot spots" 

### in/ on the soil, causing an increased formation of the dimers. The available Koc's for spirotetramat-en01were estimated from a series of soil column leaching studies. There is uncertainty in those values since the chemical is relatively labile under various conditions; however, it was found that spirotetramat-en01is too labile to withstand a batch equilibrium study. There is uncertainty related to the high levels of non-extracted residues observed very early on in the aerobic soil metabolism studies conducted with spirotetramat (22-35% of AR) and spirotetramat-enol(40- 60% of AR). The registrant indicated that these residues were immobile, but it is unknown if they are bioavailable. For the purpose of calculation of the half-life of the total residues of spirotetramat (parent, spirotetramat-en01and spirotetramat-ketohydroxy), the non-extracted residues were added as if they were persistent compounds.

Page 36 

### of 

### 120Aerobic outdoor: Anaerobic soil:

Aerobic outdoor: 25.3 (14 d) Dimethylpheny1)-3- Anaerobic soil:azaspiro[4.5]decan2. Measures of ~~uatic' Exposure

a. Aquatic Exposure Modeling For agriculturaluses, exposureconcentrationsfor aquatic ecosystems assessmentswere estimated based on EFED's Tier 11 aquatic model PRZWEXAMS. A graphical user interface (PE5 v. 5.0, November 15, 2006), developed by the EPA 

### <htt~:llm.e~a.rrov/ovvefedllmodels/water, was used to facilitate inputting chemical and use specific parameters into the appropriatePRZM input files (inp) and EXAMS chemical files. The Pesticide Root Zone Model (PRZM v. 3.12.2, May 12, 2005) field or orchard crop scenario is the basic file which describes the local or regional climatological information, soil hydrology, soil characteristics, crop characteristics, and the pesticide properties necessary to determine pesticide loadingsto ground 6r surface water. This basic file constitutesthe first part of the "exposure scenario." It simulates the processes in the agricultural field, such as runoff and erosion, on a daily time step. The runoff and erosion flux output data from PRZM are used as chemical loadings to the Exposure Analysis Modeling System (EXAMS v. 2.98.04.06, April 25,2005), which simulates surfacewater, in order to predict the EECs. EECs for ecological risk assessment were determined using a pond modeling scenario which describes a standard scenario for the EXAMS component of the modeling exercise (EXAMS Mississippipond). Tables 111.5 and 111.6 summarizethe input parameters for spirotetramat. Additional background on the models PRZM and EXAMS and the model output files areprovided in the Appendix B. The estimated exposure concentrations are summarizedin Tables 

### lII.7 and 

### III.8. Selection of

### PRZM scenarios Page 37 of 

### 120

### The PRZM scenarios selected for modeling were FL citrus, 

### NY grapes, NC apples, MI cherries, CA almond, OR Christmas trees, PA tomatoes and ID 

### potatoes. An 

### effort was made to model representative crops among all the crops in the label, with emphasis on the crops with the highest seasonal application rate. Furthermore, various regions within the continentalU.S. were selected. The PA tomatoes and ID 

### potatoes scenarios were representative of cucurbit vegetables (Crop Group 9), fruitingvegetables (Crop Group 

### 8 plus okra), leafy vegetables (Crop Group 4), brassica (cole) leafyvegetables (Crop Group 5), and tuberous and corm vegetables (Crop Group 1C). All these crop groups have the same seasonal application rate (0.16 lb a.i./A/season), the same minimum intervalbetween applications of 7 days, and the same maximum single application rate (0.08 lb a.i./A). Input Parameters 

### Maximum seasonal application rates were utilized, with the minimum intervalbetween applications. There are no usage data because spirotetramatis a new chemical. It is unknown if 

### these rates will be representativeof the typical application rates; nevertheless, they represent a conservative estimate. Since the PRZW EXAMS shell (PE5.pl) allows for the input of different application rates at different applicationintervals, when needed, the applications were set so that the maximum individual application rates were utilized for the last applications (most conservative scenario). For example, for NC apples the maximum single application rate is 0.14 lb a.i./A and the maximum seasonal application rate is 0.4 lb a.i./A; therefore, the applications were set as follows: one at 0.12 lb a.i./A and two at 0.14 lb a.i./A, in that order. Also, for CA almonds, the seasonal application rate is 0.34 lb a.i./A/season and the maximum individual application rate is 0.14 lb a.i./A. The applicationsin PRZMI EXAMS 

### were set 

### as follows: one at 0.06 lb a.i./A and two at 0.14 lb a.i./A, in that order. Applicationswere assumed to be during the mid to end of the crop season (it was presumed that during this time period foliage was present, since this chemical is efficacious when applied to foliage). Both, ground and aerial applications were modeled for this and three other crops that had the maximum seasonal applicationrates. For spirotetramat,the average 

### I(d was a better descriptor ofthe mobility of the parent. The aerobic and anaerobic aquatic metabolism half-lives were not corrected for hydrolysis. The aerobic aquatic metabolism values for spirotetramat were 1.05 and 1.06 days vs. 

### 13.1days for hydrolysis at pH 7 

### and 20°C. The average pH of the water in the studies ranged from 6.7 - 

### 7.3. The anaerobic aquatic metabolism value is 2.8 days and the pH range in the water phase was 7.7-7.9, increasing to 8.2-8.3 by the end of the study. Since the hydrolysis is dependent upon the pH and the reaction is faster at pH 9 (0.32 days at 25OC), the hydrolysis may have played a role in the degradation of spirotetramat. However, the extent of such reaction is unknown. One PRZMI EXAMS 

### runwas set for the total residues of spirotetramat

## + spirotetramat-en01

## + spirotetramat-ketohydroxy

## +non-extracted residues, which were considered of concern 

### (Table III.6). Only one crop with the aerial method of applicationwas modeled (NC 

### apples, with the highest seasonal application rate and the most conservative applicationmethod). For the total residues, the average

### li& value (fromthe study of spirotetramat-ketohydroxy), 

### was taken as a better descriptor of the mobility of the total residues since spirotetramat-ketohydroxy

### appears to be the most stable of the chemicals of concern. Also, for the total residues, the representative half-lives were obtainedby adding the values of the concentrations of the parent, spirotetramat-enol,spirotetramat-ketohydroxy and non-extracted residues, and calculatingthe half-life of their decay. In 

### those cases where one of the metabolites was stable, or no data were available, a conservative approach was taken and it was assumed that the total residues were stable (e.g.

### spirotetramat-en01was found to be stableto hydrolysis, therefore, the total residues were considered to be stable). The aerobic soil metabolism input parameter was estimated for the total residues of Page 38 

### of 

### 120

### spirotetramat-en01

## + spirotetramat-ketohydroxy

## +non-extracted residues (from the aerobic soil metabolism study conducted with spirotetramat-enol). Similarly, the aerobic aquatic metabolism input parameter was estimated for the total residues of spirotetramat

### + spirotetramat-en01

### + spirotetramat-ketohydroxy 

## +nonextractedresidues. The water solubility of spirotetramat-ketohydroxy 

### was consideredthe most adequate input parameter.

Page 39 

### of 120 Insecticide (oil dispersion) and MOVENTOm (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) OR Xmas trees

Day of Application (day-month)/ pre-harvest interval

MinimumNumber of Applications Allowed at the Maximum ApplicationRate

Minimum Interval between Applications (days)

CAM (Chemical application method) IPSCND (Flag indicatingthe disposition of pesticide remaining FL citms 0.179 x 2 NY grapes 0.0841 and 0.140 NC apples 0.134 and 0.157 x 2 MIcherries 0.112 and0.157 CA almond 0.0672 and 0.157 x 2 OR Xmas trees 0.179 x 2 PA tomatoes 0.0897 x 2 ID potato - 0.0897 x 2 FL citrus 24-11 NY grapes 01-09 NC apples 25-08 MI chemes 28-06 CA almond 14-07 OR Xmas trees 01-06 PA tomatoes 01-08 ID potato 15-08 FL citrus 2 NY grapes 2 NC apples 3 MI cherries 2 CA almond 3 OR Xmas trees 2 PA tomatoes 2 ID potato -2 FL citrus 21 NY grapes 30 NC apples 7 MI cherries 14 CA almond 14 OR Xmas trees 14 PA tomatoes 7 ID potato -7 2 1 Label PHI: FL citrus 1day NY grapes 7 days NC apples 7 days MI cherries 7 days CA almond 7 days OR Xmas trees N/A PA tomatoes 1day IDpotato 7 days Label

Label

Label 0.075 and 0.125 NC apples 0.12 and 0.14 x 2 MI cherries 0.10 and 0.14 CA almond 0.06 and 0.14 x 2 ORXmastrees 0.16 x 2 PA tomatoes 0.08 x 2 ID potato -0.08 x 2 Estimatedfrommetadata file and proposed labels.

Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOm (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases)
Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOm (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases)

2, linear foliarbased on crop canopy 1,pesticide remaining on foliage is convertedto surfaceapplication toPage 40 of 

### 120 DEPI =Incorporation Depth (cm)

Kd (mug)

Aerobic SoilMetabolism (days)

Method of Application

BufferZone (ft.)

Application Efficiency (hction) SprayDrift (hction) Solubility in Water (ppm)

Aerobic Aquatic Metabolism (days)

Anaerobic Aquatic Metabolism (days)
Hydrolysis at pH 7 half-life (days)

Aqueous Photolysis @pH 7 (days)

Molecular Weight (g/mole) 0.0

4.39

0.298

Ground and aerial

N/A

0.99 for ground application 0.95 for aerial application 0.0 1 for ground application 0.05 for aerial application 335

1.07

8.4

13.1

14.4

373.45 Label

OECD Monopph Annex B. Spirotetramat.B,8 Fate and BebaviOUT
OECD Annex B. S~irotetramat. B.8 Fate and Behaviour

Label

Label

---

--

OECD Annex B. Spirotetramat.B.8 Fate and Behaviour OECD Annex B. S~irotemat. B.8 Fate and BehaviOur

OECD ~~~~~~~~h Annex B. Spirotetramat.B.8 Fate and Behaviour OECD ~~~~~~~h Annex B. Spirotetramat. B.8 Fate and Behaviour OECD Mono~~h Annex B
. Spirotetramat. B.8 Fate and Behaviour OECD Monograph Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOm (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) The averageKn value, asper EKD guidanceon input parameters for PRZMIEXAMS dated 2/28/02. The Kd value representsbetter the mobilityof spirotetramat (relative standard deviationis smaller). Representsthe 90' percentile of the upper confidence bound on the mean of four half-life values (FL SL; tin= 0.30 days, SL; tin= 0.24 days, SL,tin= 0.26 days, Si; tl,z= 0.09 days) (DFOPbest fit kinetics). Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, inboth cases) Proposed labels BY1 8330 150 OD Insecticide (oildispersion) and MOVENTOm (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) EFED guidance on input parameters for PRZMIEXAMS dated 2/28/02, EFED guidance on input parameters for PRZM/EXAMS dated 2/28/02 10Xthe actual solubility as per EFED guidance on input parameters for PRZMEXAMS.
Representsthe 90' percentile of the upper confidencebound on the ma of two half-life values (L sediment;tln=1.06 days, LS sediment;t1,2=1.05 days) (SF0 kinetics). Determined the available half-life (2.8 days) by 3 to for the uncehty associatedwith using a single value (SF0 kinetics). EFED guidance On parameters for PRZM/EXAMS dated 2/28/02 (SF0kinetics).

tin= 14.4 Phoenix, AZ days, maximum darkcontrolled available .,due (SFO kinetics),



### ---Vapor Pressure (torr or mmHg)

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

Environment Field Size Runoff FEXTRC, Foliar extraction
PLDKRT, Decayrate on foliage
PLVKRT, Volatilizationrate from foliage UPTKF, Uptake factor
WriteBenthic PoreWater Concentrations?

Page 41 of 120 ChemicalName

CropNames

ApplicationRate

Day of Application (day-month)/ pre-harvest interval Minimum Number of Applications Mowed at the Maximum ApplicationRate
Minimum Interval between Applications (days) 4.2x10-~~

6.90~10.'~

pond298.exv EPA Pond none 0.5
0
0
0

Yes

Spirotetramat

NC apples

Kg a.i./ha NC apples 0.134 and 0.157 x 2 NC apples 25-08 NC apples 3

NC apples 7 Annex B. Spirotetmmat. B.8 Fate and Behaviour OECD Monograph Annex B. Spirotetramat. B.8 Fate and Behaviour OECD Monograph Annex B. Spirotetramat.B.8 Fate and Behaviour 

### --- --- --- ---

---

---

---

-- --

---

Default forpond scenario, as opposed to index reservoir. 

### --- WED guidance on input parameters for PRZMEXAMS dated 2/28/02 EFED guidanceon input parameters for PRZh4EXAMS dated 2/28/02 EFED guidanceon input parameters for PRZWEXAMS dated 2/28/02 EFED guidanceon input parameters for PRZMIEXAMS dated 2/28/02 For informationonly

Label

Label

Label

Label PHI: NC apples 7 days Label

Label Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) Label applicationrate Ib a.i./A: NC apples 0.12 and 0.14 x 2 Estimated from metadata file and proposed labels. Proposed labels BY1 8330 150OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, inboth cases) Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264-Page 42 of 

### 120 Aerobic SoilMetabolism (days)

Method of Application

BufferZone (ft.)

Application Efficiency (fraction) SprayDrift (fraction) Solubilityin Water (ppm)

Aerobic Aquatic Metabolism (days) Total Residues 222.3 days

Aerial

N/A

0.95 for aerial application
0.05 for aerial application
2280

Total Residues 563.3 days OECD Monograph Annex B. S~irotetramat. B.8 Fate and BehaviOur

Label

Label

---



### ---

OECD Monograph Annex B. Spirotetramat. B.8 Fate and BehaviOur
OECDMonograph Annex B. Spirotetramat.B.8 Fate and BehaviOur represents better the mobility of spirotetramat-ketohydroxy,the termid degradate and the most stable (relative standard deviation is smaller). Representsthe 90& percentile ofthe upper confdence bound on the mean of four half-life values for the total residues of the en01 and the ketohydroxy (all possible significant figures used, use of loglinearparameters) (ttn = 203.82 days, t1,2 = 169.02 days, tl~z = 161i16days, tin= 203.82 days; mean = 184.455 days; std. dev. 22.58984 days). Proposed labels BY1 8330 150 OD Insecticide (oildispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) Proposed labels BY1 8330 150 OD Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264- XXX, proposed, in both cases) EFED guidance on input parameters for PRZMIEXAMS dated 2/28/02. EFED guidance on input parameters for PRZMiEXAMS dated 2/28/02 10Xthe actual solubilityof spirotetramat-ketohydroxy,the more stable and the latter ofthe three species, asper EFED guidanceon input parameters for PRz,M/EXAMS. For the parent + en01+ ketohydroxy, represents the 90" pmentile of the upper confidence bound on the mean oftwo half-life values 385.00; 693.00, 141.43, 256.67 days; std. dev =237.794There is a relatively high degree of certainty on the input parameters for the runs for the parent only. The database was substantially complete. 

### In some instances multiple values were available, from which the input values were derived (e.g. aerobic aquatic metabolism -two half-lives, and aerobic soil metabolism - four half-lives). In other instances, the available value was multipliedby three to account for the uncertainty due to the fact that there was only one value. (e.g. anaerobic aquatic metabolism - 8.4 days, from 3x23 days). For the aqueous photolysis, the single value available was entered - 14.4 days. For the parent, there are various routes of dissipation. This is reflected in the input parameters in PRZMI EXAMS OECD Monograph

Page 43 of 

### 120 Vapor Pressure (ton or mmHg)

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

Environment Field Size Runoff FEXTRC, Foliar extraction
PLDKRT, Decay rate on foliage PLVKRT, Volatilizationrate from foliage WTKF, Uptake factor
WriteBenthic Pore Water Concentrations? 4,2x10-i~

6.90x10-'~

pond298.exv EPA Pond

none 0.5
0
0
0
Yes Spirotetramat.B.8 Fate and Behaviour OECD Monograph Annex B. Spirotetramat.B.8 Fate and Behaviour OECDMonograph Annex B. Spirotetramat.B.8 Fate and Behaviour 

### --- ---
--- ---

---



### ---

---



### -- Assumed to be the samethan for the parent, dueto similar structures.

Assumed to be the samethan for the parent, due to similar structures.

Default for the standard pond scenario, as opposedto index reservoir. 

### --- EFED guidance on input parameters for PRZMIEXAMS dated 2/28/02 EFED guidanceon input parameters for PI1ZMIEXAMS dated 2/28/02 EFED guidance on input parameters for PRZhUEXAMS dated 2/28/02 EFED guidanceon input parameters for PRZMIEXAMS dated 2/28/02 For informationonly

### (input values 0.298 days for aerobic soil metabolism, 1.07 days for aerobic aquatic metabolism, 8.4 days for anaerobic aquatic metabolism, 13.1 days for hydrolysis and 14.4 days for aqueous photolysis). On the other hand, the total residues (spirotetramat

## + spirotetramat-en01

## + spirotetramat-ketohydroxy)were assumed to be stable to hydrolysis, aqueous photolysis and anaerobic aquatic metabolism (the most conservative case). These residues appeared to degrade relatively slowly, compared to the parent alone (input values 222.3 days for aerobic soil metabolism and 563.3 days for aerobic aquatic metabolism). Modeling Results



### For the aerial runs, the peak EECs lied within a relativelynarrow window consideringthe differences in number of applications and rates of applications,the dates of application,the number of crops, the location of such crop scenarios, and other factors (range 0.244 - 

### 0.573 ppb). NC apples ground1 0.4131 7 CA almonds ground 0.34131 14 OR Xmas trees ground/ 0.321 21 14



### For the four crops with the highest seasonal application rate, which were also the crops with the highest peak EECs (0.395-0.573 ppb), aerial and ground applicationswere simulated. For those applications, a clear pattern was observed, with substantial decreasesin the peak EECs when the aerial runs were compared with the ground runs (35% for the NC apples scenario or 0.573 vs. 0.373 ppb; and 7580% decreases for the other three scenarios:0.452,0.395 and 0.450 ppb vs. 0.1 10,0.0812 and 0.0901 ppb for the FL citrus, CA almond and OR Christmas trees scenarios,respectively). Table 111.8. Estimated exposure concentrations of spirotetramat plus degradates of concern (spirotetramat-en01 and spirotetramat-ketohydroxy) (ppb)in the water column.

A chosen representative scenario for spray applications of spirotetramat to agricultural crops. Application rate in lb a.i.lA and interval between applications in days. 0.372 0.0812 0.090 1

Page 44 of 

### 120 0.0602 0.0132 0.0226 0.0227 0.00569 0.00825I I Qchosen representative scenario for spray applications of spirotetramatto agricultud crops. Application rate in lb a.i./A and intervalbetween applications in days. 

### The EECs for the total residues (spirotetramat

## + spirotetramat-en01 

### + spirotetramat-ketohydroxy

## +nonextracted residues) were obtained under the most conservative scenario,with the assumptionsthat the total residues are stableto anaerobic aquatic metabolism, hydrolysis and aqueous photolysis (due to the absence of data or it was inferred from the studies). The other half-lives were obtainedby adding the total residues and watching their decay with time. The peak EEC for the total residues with the NC apples scenario was 20 times higher than the one for spirotetramatonly (1 1.4 vs. 0.573 ppb). The 21-day EEC for the total residues was 72 times higher (1 1.1 vs. 0.154ppb) while the 60-day EEC was 192 times higher than the corresponding EEC for spirotetramat (10.8 vs. 0.0563 ppb). b. 

### Aquatic Exposure Monitoring (Field Data) No products containing spirotetramat are available in the market at this time; accordingly,no monitoring studies are available concerning aquatic exposure (both surface and ground waters). 3. Measures of Terrestrial Exposure

a. Exposure Modeling: Non-Target Mammals and Birds A primary concern with spirotetramatis that birds and mammals may be exposed shortly after application through oral or dietary exposure to vegetative plant material or insects when foraging in the treated fields for nesting material or food. Therefore, for spirotetramat spray applications, estimation ofpesticide concentrations in wildlife food items focuses on quantifying possible dietary ingestion ofresidues on vegetative matter and insects. The EFED terrestrial exposuremodel 

### T-REX (T-REX, Version 1.3.1, dated December 7,2006) is used to estimate exposures and risks to avian and mammalian species. Input values for avian and mammalian toxicity as well as chemical application and foliar dissipation half-life data are required to 

### run the model. The model provides estimates of exposure concentrations and risk quotients (RQs). Specifically,the model provides estimates of concentrations (upper-bound and mean) of chemical residues on the surface of different types of foliage and insects that may be dietary sources of exposure to avian, mammalian, reptilian, or terrestrial-phase amphibian receptors. The surfaceresidue concentration (ppm) is estimated by multiplying the application rate (pounds active ingredient per acre) by a value specific to each food item (termedthe Hoerger-Kenaga estimates). For multiple applications,the EEC is determined by adding the mass on the surface immediately following the application to the mass of the chemical stillpresent on the surfaces on the day of application (determined based on first order kinetics using the foliar half-life as the rate constant). The Hoerger-Kenaga estimates and a more detailed discussion of the methodology implemented by 

### T-REX can be found at 

### h~://cvww.epa.g;ov/oppefedl Imodels/terrestriall. In the case of spirotetramat,the Agency did not have to rely on the T-REX default foliar half-life of 35 days. Instead, scientifically valid and statistically robust foliar dissipation data were available. Following similar lines of reasoning as outlined in the aquatic exposure assessment, terrestrial exposure modeling was performed using both a parent-only approach, as well as a total residues approach that considered the residues of concern to be those of the parent spirotetramat,spirotetrarnat-enol, and spirotetramatPage 45 of 120

### ketohydroxy. To take a total residue approach, representative half-lives were determined based on the data from the available studies by adding the values of the measured concentrations of the parent, spirotetramatenol, and spirotetramat-ketohydroxy, 

### and calculatingthe half-life of their decay based on measurements at various points of time. For the parent-only approach, representative half-lives were obtained using only the available data on the concentrations of the parent, and calculatingthe half-life of their decay. The data on which the calculated half-lives are based were from two studies with leafy vegetables and one study on wheat and soybeans. The two studies on leafy vegetables were both guideline studies (Guideline 17 1-4) that were reviewed and found acceptableby the Office of Pesticide Programs' (OPP) Health Effects Division (HED), 

### and the other study on wheat and soybeans was a non-guideline studythat was reviewed and found acceptable by the Austrian Agency for Health and Food Safety (AGES). All studies were magnitude of residue studies in which the residues in and on plants were measured and accounted for (as opposed to just measuring dislodgeable residues), and all met the basic criteriaby which magnitude of residue studies are deemed acceptable for use in ecological risk assessmentsby EFED scientists (i.e., whole leaflwhole plants residues were measured, time zero measurements were taken, and at least three different samples at three different times were taken). Crops for which sound half-lives could be estimated include celery, spinach, lettuce, cabbage, broccoli, soybeans, and wheat. 

### In total, 16 

### foliar dissipation halflives were calculated for each of the parent-only and total residues approaches. Then assuming these values were distributed normally, the values which representthe one tail upper 90% confidence limit of the mean half-lives for the parent and total residue approacheswere calaculated to be 3.3 and 5.3 days, respectively, as per EFED guidance. It should be noted that the label-recommended minimum application intervals (range from 7 to 30 days depending on the crop) are less than the calculated half-lives for both the parent-only and total residues approach. This suggests that the compound remains effectivein the environment against target pest species for periods of time longer than might be suggested by these estimated half-lives. Whether the discrepancybetween the duration of effectiveness against target pests and the estimated foliar dissipation half-lives can be explained by high toxicity versus the possibility of underestimation ofpersistence of the compound remains unclear. Subsequently, how well the patterns of dissipation observed on the agricultural crops reflects actual foliar dissipation expected in the environmenton relevant food items is uncertain, and therefore, so is the extent to which EECs may be over- or underestimated. For this risk assessment, the T-REX model was run for agricultural uses with the maximum single application rate and number of applications as proposed on the label, and the minimum application interval for various crops. Risks could also be overestimated if the actual application rates, frequency of application,or number of applications are lower than the input parameters used for the conservative exposure scenarios that were modeled for the various crops. Input values used for estimating avian and mammalian exposure risks to spirotetramatare summarized in Table III.9. 

### Additional discussion with regards to the terrestrial modeling approach and resultant EECs and RQs is presented in the "Risk Description" section of the assessment. Sample model output for the maximum terrestrial exposure scenario considered in this assessment (Pome hitscenario based on total residues approach) can be found in Appendix 

### F.

Page 46 

### of 120om two guideline studies (MRID 46904508 and MRID 46904509) and one nonBy comparing estimated concentrations to acute and chronic toxicity reference values, acute and chronic RQs are calculated. The EECs on food items may be compared directlywith dietary toxicity data or convertedto an oral dose, as is done for small mammals. For mammals, the residue concentration is converted to daily oral dose based on the fraction ofbody weight consumed daily as estimated through mammalian allometric relationships. The screening level risk assessment for spirotetramatuses upperbound predicted residues as the measure of exposure. Summaries of the predicted uppa-bound and mean residues of spirotetramatthat may be expected to occur on selected avian or mammalian food items immediately following application for the maximum use scenarios for various crops are presented in 

### Table 111.9. Based on the maximum spirotetramat spray application scenarios for all crops, the parent-only approach yielded spirotetramat concentrations on foliar surfaces ranging from 1.48 to 43.10 ppm for upper-bound residues and 0.69 to 15.26ppm for mean residues. The total-residues approach yielded spirotetramat concentrations on foliar surfaces ranging from 1.68 to 52.44 ppm for uppa-bound residues and 0.78 to Page 47 of 

### 12018.57 ppm for mean residues. Concentrationswere highest on the surfaces of short grass for the maximum pome fruit usage scenario and lowest on the surfaces of fruits, pods, and large insects for the maximum cucurbitvegetable usage scenario. 

### b. Exposure Modeling: Non-target Invertebrates Currently, the Agency doesnot quantitatively evaluatethe potential exposure of terrestrial invertebratesto pesticides for screening level assessments for non-endangered species.


### c. Exposure Modeling: Non-Target Plants Inhabiting Dry (Upland) and Semi-Aquatic (Wetland) Areas Exposure to upland and wetland plants is estimated using the TerrPlant (v1.2.2) screeningmodel. TerrPlant estimates potential exposure from a single application using default assumptions for runoff and spray drift 

### (Table lII.10). For runoff plus drift, TerrPlant incorporatestwo similar conceptual models for depicting

### dry and semi-aquatic areas of terrestrial habitats. For both models, a non-target area is adjacent to the treated field. Pesticide exposures to plants adjacent to the treated field are estimated to include runoff and drift from the treated field. For a 

### dry area adjacentto the treated field, runoff exposure is estimated as sheet runoff. 

### In the model, sheet runoff is defined as the amount of pesticide in water that runs off of the soil surface of a treated field which is equal in size to the non-target area (1 :1 ratio of areas). For semi-aquatic areas, runoff exposure is estimated as channelized runoff. 

### In the model, channelized runoff is the amount of pesticide that runs off of a treated field 10times the size of the area adjacent to the treated field (10: 1 ratio of areas). The drift component is calculated as 1 % of applied mass (for ground spray) or 5% of applied mass (for aerial spray, airblast, or spray chemigation). Other inputsto the model (besides a drift haction of either 0.01 or 0.05) include the maximum single applicationrate, incorporation depth, and runoff fraction. While the application rate and incorporation depth are label-specified,the enteredrunoff fkaction is selected based on the solubilityof the compound of interest, and can be 0.01, 0.02, or 0.05 if the solubility of the compound is 40 ppm, 10to 100ppm, or >I00 ppm, respectively. See 

### Appendix G for additionalinformation. Specificallyfor spirotetramat, estimates were generatedby assuming that it was not ground incorporated, and that it was applied at the maximum single applicationrate for all uses (0.16 lb a.i/A) with aerial applicationmethods (drift fraction = 0.05). Lastly, since plant toxicity data arenot available for the spirotetramat degradates, it was assumed that they are equivalent to the parent in terms of toxicity and a total residue approach was taken. Subsequetly, although the solubilityof the parent is 29.9 mg/L, the degradates of concern are more soluble (solubility= 2700 mg/L and 228 mg/L for spirotetramat-en01and 

### spirotetramat-ketohydroxy,respectively), and the overall solubilityof the total residues of concern was assumed to be greater than 100mg/L. Therefore, the solubility fraction was entered as 0.05. Once exposure estimates are generated, they can then be compared to measures of plant growth and survival to develop risk quotient (RQ) values. For RQs for non-listed and listed species of monocots and dicots inhabiting

### dry and semi-aquatic areas, EECs for the combined deposition estimates from runoff and spray drift (total loading estimates) are directly compared with most sensitive measure of effect from the available seedlingemergence studies. For RQs for non-listed and listed species of monocots and dicots exposed solelyvia spray drift, the EECs for spray drift deposition only (without a runoff exposure component) are directly compared with the most sensitivemeasure of effect from either the vegetative vigor or seedlingemergence studies.

Page 48 of 120As can be seen in 

### Table III.10 below, the EECs for drift only, total loading to 

### dry areas, and total loading to semi-aquatic environments based on the maximum exposure scenario of all crops are 0.008,0.016, and 0.088 lb a.i./A, respectively. A quick comparison of these EECs to the most sensitive measures of effect from the available vegetative vigor and seedling emergence studies demonstratesthat due to the low toxicity of spirotetramat to terrestrial plants, RQs for listed and non-listed species are not expected to exceed Agency LOCs. Therefore, only the most conservative exposure scenario possible for spirotetramat was modeled and presented in this assessment.

EC =applicationrate x 0.05; for ground applicationsthe EEC = applicationrate x 0.01.

C. 

### Ecological Effects Characterization In screening level ecological risk assessments, effects characterization describes the types of effects a pesticide can produce in an aquatic or terrestrial organism. This characterizationis based on registrantsubmitted studies that describe acute and chronic effects toxicity information for various aquatic and terrestrial animals and plants. 

### In agreement with international governmental partners associated with registration efforts for this pesticide, evaluation and approval responsibilities of submitted studies are being met through the efforts of the Austrian Agency for Health and Food Safety (AGES). The Agency is using the summarized acute and chronic toxicity data as they appear in Volume 3, Annex B.9: Ecotoxicology monograph for registration in Europe, with the regulatory evaluation and approval as completedby the AGES. The full text of the data summaries and evaluations are available in the above volume or in 

### Appendix C of this assessment. Except where specifically reported, independent validation of statistical results for effects studies was not performed during the AGES reviews. 

### In addition, a number of studies on Movento 240 SC have been submitted, but most were not reviewedby AGES prior to this assessment. Unless the studies were found to contain the most sensitive endpoint available for a given taxonomic group based on a cursoryEFED review, or they had been reviewed previouslyby AGES, their details are not discussed within the body of this assessment. Toxicity testingreported in this section does not represent all species ofbirds, mammals, or aquatic organisms. Only a few surrogate species for both freshwater fish and birds are used to represent all fieshwater fish (2000+) and bird (680+) species in the United States. For mammals, acute studies are usually limited to Norway rat or the house mouse. Estuarinelmarinetesting is usually limited to a crustacean, a mollusk, and a fish. Also, neither reptiles nor amphibians are tested. The risk assessment assumes that avian and reptilian toxicities are similar. The same assumption is used for fish and aquatic amphibians.
Page 49 of 120

### In general, categories of acute toxicity ranging from "practically nontoxic" to "very highlytoxic" have been established for aquatic organisms (based on LCSo and ECSO values), mammals (based on LDSO values), avian species (based on and LDSO and LC50 values), and non-target insects (based on LDSO values for honey bees) (U.S. EPA 2001). Toxicity classifications are based on the scheme outlined in 

### Appendix I. 

### 1. Toxicity

### Data Summary The limited available data for formulated products suggested no concern for enhanced toxicity of formulations versus the active ingredient alone. Therefore, the most sensitive endpoints, regardless of whether for the technical grade or the formulations,will be considered for use in this assessment for characterizing toxic effects of spirotetramat and deriving risk estimates. While acute toxicity data with aquatic receptors suggest that the degradates are equivalent to (for duckweed) or lower in toxicity than the parent (all other instances) for the taxonomic groups tested, the dataset is incomplete and there is insufficient evidence for precluding similar toxicity of the degradates to the the parent for mammals, birds, gamasid mites, and earthworms. Therefore, this assessment conservatively assumes equivalent toxicity among them. Spirotetramat can be classified as practically non-toxic to birds (LD50>2000 mag-bodyweight; LCSo>5000 mgikg-diet) and mammals (LDS0>2000 mag-body weight) on an acute basis. Although there currently is no toxicity classification scheme for earthworms, based on the available information, spirotetramat appearsto be of relatively low toxicity to earthworms as there were no observedtoxic effects up to the highest concentration tested in the sub-chronic 14-day study (NOAEC= 1000mgikg-dryweight soil). Only a 14-day studywith 4-methoxy-cyclohexanone (J body weight; NOAEC=125 mgikg-dry weight soil) and an 8-week studywith spirotetramat-en01(J reproduction;NOAEC=32 mag-dryweight soil) demonstrated any toxic effects to earthworms. Although spirotetramat can be classified as practicallynon-toxic to honey bees (LDS0 range = 91.7 to 162 pg a.i./bee for both oral and contact studies), results ofbrood feeding studies and tunnel tests suggest the potential for effects to broods following spirotetramat applications at rates lower than the maximum proposed label rates; significant brood effects including increased mortality in adults and pupae, massive perturbation ofbrood development, early brood termination, and decreased larval abundance were detected. Spirotetramat also had a wide range in magnitude of acute effects on other various non-target terrestrial arthropods, with toxicity values ranging from 

### an LRSO greater than the highest rate tested (0.26 lb a.i./A) for a 48-hour acute contact studywith parasitoid wasp adults exposed to dried residues on treated barley plants, to an = 0.0003 lb a.ilA for a 14-day acute contact toxicity test with predatory mites exposed to dried residues on treated glass plates. For plants inhabiting dry and semi-aquatic areas, there were no detrimental effects for any measured parameter in dicots or monocots at or above 25% as compared to the controls in the Tier 

### I seedling emergence study at the single applicationrate of 0.16 lb a.i./A. However, there were some significant adverse effects observed in the available vegetativevigor studies including: reduced shoot dry weight of shattercane(EC25, =0-06lb a.i./A; NOAEC=0.02 lb a.i./A); reduced length (EC25 =0.09 lb a.i./A; NOAEC=O.OS lb a.i./A), dry weight (EC2~ =0.07 lb a.i.lA; NOAEC=0.04 lb a.i./A), and fresh weight (EC2S =0.20 lb a.i./A; NOAEC=0.13 lb a.i./A) of corn; reduced dry weight of ryegrass (EC2S =O. 15 lb a.i./A; NOAEC=0.08 lb a.i./A); reduced fresh weight of canoh (EC2S =O. 17 lb a.i./A; NOAEC=0.06 lb a.i./A); and reduced fresh weight of oats (EC2S =0.19 lb a.i./A; NOAEC=0.13 lb a.i./A).

Page 50 

### of 

### 120

### Spirotetramat can be classified as moderately toxic to freshwater (LC50 range= 1.41to 2.59 mg a.i./L) and estuarinelmarine fish (LC50=1.96 mg a.i./L), slightly to highly toxic to freshwater invertebrates (EC50 range
= 

### 0.66 to >42.7 mg a.i./L), and moderately to highly toxic to estuarinelrnarineinvertebrates (EC50 range= 0.85 to 5.5 mg a.i./L) on an acute basiq. Although there is no toxicity classification scheme for aquatic vascular and non-vascular plants, toxic effects were demonstratedin the available studies with duckweed (effects on yield and growth; lowest EcSo=4.49 mg a.i./L, NOAEC=1.54 mg a.i./L) and algae (effects on biomass and growth rate; lowest EC5o=0.36mg a.i./L, NOAEC=0.124 mg a.i./L). Avian reproduction studies demonstratethat there is concern for longer-term exposure to spirotetramat with potential for growth and reproductive effects. The NOAEC value of <28.8 mglkg-diet for birds was based on a -6.58% reduction in mean hatchling bodyweight at the lowest test level. Although no additional statistically significant effects were observed at this test level, large reductions in other frank effects that were observed at 28.8 mglkg-diet included reductions in # 

### of 14-day survivors (422%), # 

### of viable 14-dayembryos (4 18%), # 

### of live embryos (4 18%), and # 

### of eggs hatched (422%). Due to the degree of these reductions, it is hard to indicate that these effects arenot biologically significant and are considered meaningful. Thus, because of the extent of these observed effects, it is reasonable to assume they are significant biologically. The 2-generation rat reproduction study demonstratedthe potential for parental systemic, reproductive, and offspring effects to mammals, and established a NOAEC of 1000mgkg-diet (LOAEC of 6000 mgkgdiet). Observed effects at the LOAEC included: decreased body weight and body weight during lactation in both F1and F2generations; abnormal sperm cells and decreased reproductive performance in the F1males; decreasedbody weight 

### (F1males and females), weight gain (P 

### males, F1males and females), and food consumption during lactation (P- 

### and F1-generationfemales); and kidney histopathology and decreased kidney weights (FI

### males and females). In 

### the available aquatic studies, observed chronic/reproductiveeffects included: decreased survival in the early-life stage studywith fathead minnows (NOAEC=0.534 mg a.i./L, LOAEC=l. 16mg a.i./L); decreased emergence (NOAEC=O. 1 mg a.i./L, LOAEC=0.2 mg a.i./L).and developmentalrate (NOAEC=0.8 mg a.i./L, LOAEC=1.6 mg a.i./L) in the 28-day spiked-water study with midges; and decreased reproduction (NOAEC=5 mg a.i./L, LOAEC=12.5 mg a.i./L), decreased parental growth (NOAEC=5 mg a.i./L, LOAEC=12.5 mg a.i./L), and increased mortalityin adults (NOAEC=2 mg a.i./L, LOAEC=5 mg a.i./L) in the life-cycle studywith water fleas.

Page 

### 51 of 

### 120

## I I 

# I Bobwhite quailLC5o >5000 mg/kg-diet 

## I 

# I Birds

Mammals Reproduction and growth 

# I Mallard NOAEC <28.8 mgkg-diet
Survival Rat LD50>2000 mglkg- body weight Reproduction and growth

I I 

## 1 Survival 

## I Midge 48-hour ECS0 = 0.66 mg a.i.lL 

# 1 Rat LCSo >2000 mglkg-diet Rat NOAEC= 1000mglkg-diet (70.7 mg/kg- body weight)

lkshwaterfish

Estuarinelmarine fish Survival Reproduction and growth
Freshwater invertebrates

Estuarinelmarine

invertebrates Rainbow Trout 96-hour LCs0= 1.4 1 mg a.i.1L Fathead minnow NOAEC= 0.534 mg a.i.1L

Terrestrialplants Reproduction and growth - Water flea NOAEC= 2.0 mg a.i./L Survival Reproduction and growth Survival Reproductionand growth Seedling emergence: Non-listed Monocots Listed Monocots Seedling emergence: Non-listed Dicots Listed Dicots Vegetative Vigor: Non-listed Monocots

Listed Dicots 

## I NOAEC>0.16 lb a.i./A 

## I Sheepsheadminnow 96-hour LC50= 1.96mg a.i./L No study available Eastern oyster 96-hour EC50=0.85 mg a.i./L No study available
EC2s>0.16 lb a.i.1A NOAEC>O. 16 lb a.i./A
ECZ5>0. 16 lb a.i.1A NOAEC>O. 16 lb a.i.1A
ECZ5= 0.06 lb a.i./A Listed Monocots Vegetative Vigor: Non-listed Dicots Aquatic plants

(vascular) & Algae (non-vascular) NOAEC= 0.02 lb a.i.1A
EC25>0. 16lb a.i./A
Survival and growth: Non-listed Survival and growth: Listed 

# P Duckweed (vascular) 96-hour EC5O=4.49 mg a.i./L Skeletonema costatum (non-vascular)EC50=0.36mg a.i./L Duckweed (vascular) 96-hour NOAEC = 1.54 mg a.i./L Skeletonema costatum (non-vascular) 96-hourNOAEC=O. 124 mg a.i./L 

# I

I I 

## 'Measurement endpoint was based on a -6.58% reduction in mean hatchlingbodyweight at the lowest test level. 'A conservative estimate of dietary acute toxicity was generated using the existing rat oral LDSo and assuming a conservative ingestionrate of 100 percent of the body weight. The resulting estimated dietary acute toxicity endpointis 22000 m&-diet [(>2000mgkg-bw)(l kg-bwllkg-diet) =>ZOO0 mgkg-diet].

Measurementendpoint was based on a study conductedwith a SpirotetramatOD 150. Because a comparisonofthe availabledata suggeststhat the toxicity of the technical gradeactive ingredient (TGAI) and formulated spirotetramatis roughly equivalent (overlapping confidence intervals),the most sensitive measurement endpoint was chosen regardless ofwhether it was based on the TGAI or a formulated product.

There were some effects on canola in one vegetativevigor study. A slightlyhigher, but definitiveECzs=0.17 lb a.i.1A was generated, and so was a lower NOAEC = 0.06 lb a.i.1A. However, the more conservativeECzs (N. 16 lb a.i.1A) and the associatedNOAEC were selected for use. Page 52 of 

### 120

### 2. Aquatic Toxicity

a. Acute Effects

Chironomusriparius

Page 53 of 120b. Chronic/ReproductiveEffects



### 3. Terrestrial Toxicity a. Terrestrial Vertebrates

1. Acute Effects

Page 54 of 120ii. Chronic/ReproductiveEffects Acute oral LD50 LD50> 2000 mgikg-bw

Page 55 of 120 Acute oral LD50

Acute dietary LCs0

Acute dietary LC50

a Not statistically determined. Spirotetramat

Technical

Spirotetramat

Technical

'Spirotetramat

Technical Colinus virginianus (Northern bobwhite)

Colinus virginianus (Northern bobwhite)

Anus pla~~hYnchos

(Mallard) NOAEL < 500 mgikg-bw a

NOAEL = 1000 mg/kg-bw a

LCso> 5000 mgikgdiet

NOAEC= 1250 mgikg-diet

K50' 6050 mgikg-diet

NoAEc < 344 mglkg-diet Diarrhea, soft excrement, reduced feed consumption Decreasedbody

weight, and 2 mortalities at the

highest dose No treatment-related mortalities

Decreasedbody weight gain and feed consumption
No treatment-related mortalities

Decreasedbody weight gain and feed cmumption Barflcnecht, 2003

Bdecht, 2004

Stoughton,

2005NOAEC = 264 mgikg-diet



### b. Terrestrial Invertebrates

Page 56 of 120Page 57 of 120 adults and pupae.

No adverse effect.

Apis mellifra

(Honey bee)

Apis rnellifra

(Honey bee)

Apis mellifea

(Honeybee)

Aphidius rhopalosiphi (Parasitoid

wasp) Typhlodromus ~~ri (Predatory

mite) Aphidius rhopalosiphi (Parasitoid

wasp) Feeding test, mixed in sucrose solution at 0.0144 % a.i. Each colony received lkguntil gone. Semi-field study, 2 applications on

crop before flowering at 0.064 lb a.i./A 

### + 2 xapplications at

0.064 Ib a.i./A after flowering or 2 applications at 0.086 lb a.i./A Semi-field study (tunnel design), 3 applications on

cropbefore colony set-up at 0.064 lb a.i./A + 2 applicationsat 0.086 lb a.i./A after colony setup, or 1 application at 0.086 lb a.i./A 3 days after colony set-up Contact with dried residues on

treated glass plates Contact with dried residues on

treated glass plates Contact with dried residues on

treated barley plants Spirotetramat SC 240

Spirotetmmat

OD150

Spirotetramat

OD100

Spirotetmmat

OD150 Spirotetramat

OD150 Spirotetramat

OD150 Brood effects Mortality

Behavior Brood effects

Mortality

Behavior

Brood effects

Mortality

Behavior

Brood effects

Mortality
Mortality Mortality Reproduction Fed until gone. Available up

to 7 days. Obsmtions made for 2 1 days.

Observations made for 28 days.

Observation made for 23 

### -

29 days.

48 hours

7 days

48 hours High terminationrate in two of three colonies. Increased adult mortality.

No adverse effect. Terminationof brood development with tendency to recover. No adverse effect.

No adverse effect.

No adverse effect.

No adverse effect.

No adverse effect.

No adverse effect.

LDso = 0.102 lb a.i./A

m5o = 0.0003 lb a.i./A
LD5o >0.26 lb a.i./A NOEC = 0.26 lb a.i./A Schur, 2004b

Schur, 2006

Schur, 2005

Waltersdorfer 2005a
Waltersdorfer 2005b
Waltersdorfa 2006a

### In addition to the data presented in the table above for terrestrial invertebrates,Bayer Cropscience AG has also submitted additional non-GLP tunnel and tent data (without formal reports) under FIFRA 

### 6(a)(2) that evaluate spirotetrarnat's pollinator compatibility. These data are discussed briefly in the "Risk Description" section of the assessment.
c. Terrestrial Plants

Page 58 of 

### 120 LDso = 0.0014 lb a.i./A NOAEC <0.0001 lb a.i./A Significantmortality (>51%), was observed forup to 7 weeks after exposure to apple leaves treated 4 times at 0.064 lb a.i./A L.D50>0.26 lb a.i./A NOEC = 0.26 lb a.i./A LD50 >0.26 lb a.i./A

NOEC = 0.26 lb a.i./A ECso/LC50> 1000 mgkg-dw soil

NOAEC= 1000mgkgdw soil EC~O~LCS~ 1000 mgkg-dw soil NOAEC= 1000mgkgdw soil EC50/LC59 1000 mgkg-dw soil NOAEC= 1000 mgkg-dw soil EC~O/LC~O> 1000 mgkg-dw soil NOAEC= 1000mgkg-dw soil ECswLCso> 1000 mgkg-dw soil NOAEC= 1000mgkg-dw soil ECsO/LC5+ 1000mglkg-dw soil NOAEC= 125 mgkg-dw soil EC5olLC50> 1000mgkg-dw soil NOAEC= 1000 mgkgdw soil ECso/LCso> 1000 mgkg-dw soil NOAEC= 1000 mgkgdw soil EC50/LC5~1269 mgkg-dw soil NOAEC= 32 mgkg-dw soil EC5o/LCso>lOOOmglkg-dw soil NOAEC= 316mgkg-dw soil EC5~LC5+1000 mgkg-dw soil NOAEC= 1000mgkgdw soil 7 days

days
Exposure until

pupation
Exposure until

pupation

14 days

14days

14days

4 weeks

4 weeks

8 weeks

28 days Waltersdorfer 2005c

Waltersdorfer 2006c
Roehlig 2005

Waltersdorfer 2006b

Lechelt-Kunze 2004

Lechelt-Kunze 2005

Leicher 2008

Moser & Scheffczyk

2005

Moser & Scheffczyk

2005 Mortality Reproduction

Mortality
Mortality Reproduction

Mortality
Reproduction

Mortality
Body weight

Mortality
Body weight

Mortality
Body weight

Mortality
Body weight
Reproduction

Mortality
Reproduction Spirotetramat

OD150
Spirotetramat

OD150
Spirotetramat

150 OD
Spirotetramat

150 OD

Spirotetramat

Spirotetramatketohydroxy

4-Methoxycyclohexanone

Spirotetramaten01

Spirotetramaten01 Typhlodromus ~~ri (Predatory

mite) Typhlodromus pyri (PredatOq

mite) Chiysoperla

carnea (Green lacewing) Coccinella septempunctata (Ladybird

beetle)
Eiseniafetida (Earthworm)

Eisenia fetida (Earthworm)

Eisenia fetida (Earthworm)

Eisenia fetida (Earthworm)

Hypoaspis aculeifr (Gamasid mite) Units are mglkg Contact with dried residues on

treated bean

leaves Contact with clriedresidues (acute and aged on treated apple leaves Contact with dried residues on

treated bean

leaves Contact with driedresidues on

treated bean leaves and aphids

Contaminated

soil contact

Contaminated

soil contact

Contaminated

soil contact

Contaminated

soil contact

Contaminated

soil contact dry weight of soil.Page 59 of 120 Vegetative

vigour: Tier 1

Vegetative

vigour: Tier 11

Vegetative

vigour: Tier 11

Vegetative Vigour: Tier JIZ

Seedling emergence:

Tier I Monocots Zea mays(Corn) Avena sativa (Oats)

Dicots Cucumis sativus (Cucumber)

Brassica napus (Canola) Glycine max (Soybean) Helianthus annuus (Sunflower)

Monocots Zea mays(Corn) Avena sativa (Oats) Loliumperenne (Ryegrass) Allium cepa (Onion)

Dicots Cucumis sativus (Cucumber)

Brassica napus (Canola) Glycine max (Soybean) Helianthus annuus (Sunflower) Beta vulgaris (Sugarbeet) Lycopersicon esculentum (Tomato) Monowts Zea mays(Corn) Avena sativa (Oats)

Dicots Brassica napus (Canola)

Monowts Sorghum vulgare (Shattercane)

Monocots Zea mays(Corn) Avena sativa (Oats) Dicots Cucumis satims (Cucumber)

Brassica napus (Canola) Glycine max (Soybean) Helianthus annuus (Sunflower) Corn dry weight /56.9% at 0.26 lb a.i./A Oats dryweight 156.6%at 0.26 lb a.i./A Cucumberdryweight 141.3%at 0.26 lb a.i./A

Cucumber survival 15% at 0.26 lb a.i./A Canola dryweight 183.3% at 0.26 lb a.i./A Soybean dry weight 140.2%at 0.26 lb a.i./A Sunflowerdryweight 143.1% at 0.26 lb a.i./A Corn plant length: NOAEC = 0.04 lb a.i.i.4; ECz5=0.09 lb a.i./A Corn dry weight: NOAEC = 0.04 Ib a.i./A, EC25=0.07 lb a.i./A Ryegrass plant length: NOAEC = 0.08 Ib a.i./A; ECz5>0.16 lb a.i.lA Ryegrassdryweight: NOAEC = 0.08 lb a.i./k, EC25=0.15 lb a.i./A No other statistical effects:NOAEC = 0.16 lb a.i./k, ECz5N.16 lb a.i./A

-

No statistical effects:NOAEC = 0.16 lb a.i./A, ECZ >0.16 lb a.i./A

Corn fiesh weight: NOAEC=O. 13 lb a.i./A, EC25 =0.20 lb a.i./A Oats fiesh weight: NOAEC=0.13 lb a.i./A, ECz5=0.19lb a.i./A No other statistical effects:NOAEC = 0.16 Ib a.i./A; ECz5 N. 16 lb a.i./A
Canola fiesh weight: NOAEC=0.06 lb a.i./A, EC25=0.17 lb a.i.lA No other statistical effects:NOAEC = 0.16 lb a.i./A, EC25 N.16 lb a.i./A

Shattercaneshoot dry weight: NOAEC=0.02 lb a.i./A, EC25=0.06lb a.i.lA No other statistical effects:NOAEC = 0.19 lb a.i./A; ECZ5 N. 19 lb a.i./A

No adverse effects ?25% at 0.26 lb a.i./A Gosch & NWY~ 2006a

Christ & Lam 2006a

L

Friedrich

2006

Gosch 2007

Gosch & NWY~ 2006bAvena saliva (Oats) Loliumperenne (Ryegrass)

Allium cepa (Onion) No adverse effects 225% at 0.16 Ib a.i./A Cucumissativus (Cucumber)

Brassica napus (Canola) Glycinemax (Soybean)



### IV. Risk Characterization Risk characterization is the integration of exposure and effects characterization to determine the ecological risk from the use of spirotetramat and the likelihood of effects on aquatic life, wildlife, and plants based on varying pesticide-use scenarios. The risk characterization provides estimation and a description 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. 

### A. Risk Estimation

# - Integration of Exposure and Effects Data Results of the exposure and toxicity effects data are used to evaluatethe likelihood of adverse ecological effects on non-target species. Laboratory environmental fate, laboratory ecological effects, and use data that provide the basis for risk estimation have been presented previously in the assessment. As discussed in greater detail in the "Analysis Plan" section of the assessment, the risk quotient (RQ) method is used to compare exposure and measured toxicity values to generateRQs that are then compared to the Agency's levels of concern (LOCs) to determinethe need to consider regulatory action. Based on the most sensitive available endpoints for each taxa quantitatively evaluated, only the chronic RQs for avian species exceed the LOC for the proposed uses of spirotetramat. 

### 1. Risks to Non-Target Aquatic Organisms To assess risk of spirotetramatto non-target aquatic animals (i.e., fish and invertebrates) and plants, surface water EECs of parent-only as well as total residues (spirotetramat

### + spirotetrarnat-en01 

### + spirotetramatketohydroxy) were obtained from the Tier 

### 2 aquatic model PRZMIEXAMS as previously described in the "Aquatic ExposureModeling" section of the assessment. Exposure and risk estimates based on both the parent-only and total residues modeling approaches are presented in order to evaluate the impact of the underlying assumptions on the risk conclusions. For both approaches, peak concentrations in surface water were used to represent acute exposure to all aquatic organisms, while the 2 1 -day average concentrations were used to represent chronic exposure to aquatic invertebrates, and the 60-day average concentrations were used for chronic exposure to fish. These EECs were then compared to the measurement endpoints described in 

### Table III.11 to derive RQs. Although many scenarios were considered and modeled for estimating exposure and risk to aquatic organisms resulting from the proposed uses of spirotetramat, only the results of the most conservative Page 60 of 

### 120

### scenario are presented below. Specifically,the NC apple aerial application scenario, based on 3 

### applicationsat a rate of 0.4 lb a.i./A/season and a 7-day interval, generated the highest peak, 21-day, and 60-day EECs. Based on this conservative modeling scenario and the available toxicity endpoints, all estimated acute and chronic RQs for aquatic animals and plants are below the Agency's LOCs for the parent-only approach, as well as the likely conservative total residues approach. Therefore, the RQs for all of the other scenarios are also below the Agency's LOCs and have not been presented here. Calculated acute RQ values for freshwater and estuarinelmarinewater-column dwelling animals can be found in Table

### IV.l, while chronic RQ values can be found in Table IV.2. 

### Calculated RQ values for both vascular and non-vascular aquatic plants arepresented in Table 

### IV.3.

fish (LC50 = 1960 pg a.i.L). e parent spirotetramatonly as well as for total residues (i.e., residues for the

OAEC = 534 pg a.i./L). S are reported for the parent spirotetramatonly as well as for total residues (i.e.,

Page 61 of 

### 120 

## I Parent only 

## I 0.573 0.0016 0.0001 0.0046 0.00042. Risks to Non-Target Terrestrial Organisms As discussed previously in the "Terrestrial Exposure Assessment" portion ofthe chapter, terrestrial exposuremodeling was performed using the 

### T-REX model (T-REX, Version 1.3.1, dated December 7, 2006) and a parent-only approach, as well as a total residues approach that consideredthe residues of concern to be those of the parent spirotetramat,spirotetramat-enol, and 

### spirotetramat-ketohydroxy. Risks were estimated for terrestrial animals in three weight categories, based on upper-bound and mean residues on four (birds) or five (mammals) forage food types for numerous crop use scenarios using the maximum singleproposed application rate, the maximum number of applications, and the minimum application interval. However, onlythe most pertinent results of these analyses conductedwith upper-bound residues " are summarized in the following tables. Total

For birds, acute RQs were derived using dose-based and dietary-based acute toxicity values, and chronic RQs were derived using a dietary-based chronic toxicity value. For mammals, acute RQs were derived using a dose-based acute toxicity value and a conservative estimate of acute dietary toxicity derived using methodology previously described in the "Ecological Effects Characterization" section of this assessment. Mammalian chronic RQs were derived using a dietary-based chronic toxicity value and a calculated dosebased chronictoxicity value (dose-based equivalent was calculatedby study authors based on food consumption during the study). All dietary-basedRQs are calculated using EECs expressed in terms of residue concentration for the various forage categories, and toxicity values (LC50 or NOAEC) are expressedin units of dietary concentration.Dose-based RQs are calculated using a body weight-adjusted toxicity value (LD5Oor NOAEL) and consumption-weighted equivalent dose sorted by food source and body size. The adjustments account for the fact that smaller-sized animals have to consume more food in terms of their body weight than larger animals and that differential amounts of food have to be consumed depending on the water content and nutritive value of the food. Additional discussion of the methodology implemented by T-REX can be found at 

### http:/lwww.epa.gov/op~efedl/models/t~aW. All measurement endpoints used to derive RQs for terrestrial animals are summarized in Table 

### III.11. a NC apple aerialapplication scenario, based on 3 applicationsat a rate of 0.4 lb a.i./A/season and a 7-dayinterval, generatedthe highest peak EECs.

Toxicity values are based on studieswith duckweed (Lemnagibba) for vascular plants (EC50 =4620 pg a.i./L; NOAEC=1540 yg a.i./L) and marine diatoms (Skeletonema costatum) for non-vascular plants (ECso = 360 yg a.i./L; NOAEC=124 yg a.i.L). ECso values areused to derive RQs for non-endangered species while NOAEC values are used to determineRQs for endangered species. " 24-hour peak EEC values generated from PRZMIEXAMSarereported for the parent spirotetramatonly as well as for total residues (i.e., residues for the parent plus degradates of concern). RQs are below the acute LOCs for aquatic plants (1). 0.0025

a. Risks to Non-Target Birds 11.4

Spirotetramat is classified as practically non-toxic to birds on both an acute oral and sub-acute dietary exposurebasis. Therefore, this risk assessment presents only acute avian RQs based on upper-bound EECs for total residues for the most conservativemodeled scenario (Table IV.4); the pome fruit scenario (maximum single application rate of 0.14 lb a.i./A, a 7-day application interval, and a maximum of 3 applications). Even under the most vulnerable scenario for birds (20 g birds foraging on short grass; see "Terrestrial ExposureAssessment7')the RQ value is <0.04, a value less than half the acute endangered species LOC of 0.1. Therefore, because no RQs exceeded the Agency's acute LOCs for birds under this upper-bound exposure scenario, the RQs for all of the other scenarios are also below the Agency's LOCs and are not presented here. 0.0919 0.03 17

Page 62 of 

### 120 0.0074

### It must be noted that chronic risk estimates for birds are based upon a non-definitiveNOAEC of <28.8 mgkg-diet (effects were seen at all tested concentrations) and all RQs are greater than the reported values. Therefore, there is uncertainty with respect to their estimated magnitude and there remains the potential for additionalchronic LOC exceedancesbeyond those that have been definitively identified below. Until a discreteNOAEC is established for chronic/reproductiveeffectsto birds, it is impossible to preclude chronic risk to birds feeding on any forage item under any exposure scenario. However, for the sake of RQ presentation below, those RQs that are currently exceedingthe chronic LOC even based on the nondefinitiveNOAEC (<28.8 mgkg-diet) have been identified separatelyfrom those that are not currently exceeding but have the potential to until a definitiveNOAEC is established. Further discussion of this uncertainty isprovided in the "Risk Description" section of the risk assessment. For chronic exposure and risk estimates to birds, parent-only and total residues modeling approaches are presented in order to evaluate the impact of the underlying assumptions on the risk conclusions. Based upon the most sensitive NOAEC (<28.8 mgkg-diet) from all the available avian reproduction studies availablefor spirotetramat, dietary-based chronic RQs for avian species (Table 

### IV.5) feeding on short grass meet or exceed the chronic risk LOC (1) 

### for allbut two of the evaluated crop use scenarios for both the parent-only (RQ range = 

### >0.82 to >1SO) and total residues approaches (RQ range = 

### >0.93 to >1.82). The two scenarios for which no chronic RQs currently exceed the LOC are the hops (RQ range = 

### >0.05 to >0.88 for parent only; RQ range = 

### >0.06 to >0.97 for total residues) and cucurbit crop scenarios (RQ range

= 

### >0.05 to >0.82 for parent only; RQ range = 

### >0.06 to >0.93 for total residues). Only one other RQ, for birds feeding on broadleafplants/small insects under the pome hitscenario when using the total residue approach, currentlyexceeds the chronic risk LOC (RQ = 

### >1.02). No other chronic RQs for birds currently exceed the LOC in any other instance.

maximum of 3 applications.

EECSandtoxicity values for the dose-basedanalysis are adjusted based on food intake andbody weight differences so that they are comparable for a given weight class of animal. 'The most sensitive LQo and LC50 values for birds were non-defmitiveas they were determined to be greaterthan the highest tested levels in the availabletoxicity studies. Therefore, because all acute RQs are based on non-definitive toxicity values, they representconservative estimates ofrisk and are expressed with a '<' sign. dAUacute RQs are below the acute LQCs far non listed species (0.5),restricteduse (0.2),and listed species (0.1).



### Dose-based Dietary-based

Page 63 of 

### 120 "The maximum exposure scenariowas the pome fit scenario,with a maximum single applicationrate of 0.14 lb a.i./A,a 7day application interval, and a 20 100 1000 NIA >I441 

### mgikg-bw >I834 

### mgikg-bw >259 1 

### mglkg-bw >5000 

### mglkg-diet 59.72

### mg/kg-bw 34.05

### mgikg-bw 15.25

### mg/kg-bw 52.44

### mg/kg-diet <0.04 <0.02 KO.01 <0.01

### b. 

### Risks to Non-Target Mammals Pome hit Xmas trees Citrus hit Tree nuts

Stone fruit Grape Climbing

Hops Cucurbit

No adverse effects were seen at the highest dose tested (2000 mg a.i./kg-bw) 

### in the rat acute oral toxicity study, spirotetramat is classified as practically non-toxic to mammals on an acute oral exposure basis, and risk is presumed to be low. Therefore, this risk assessment presents onlymammalian RQs based on upperbound EECs for total residues for the most conservativemodeled scenario (Table 

### IV.6); the pome hit scenario (maximum single applicationrate of 0.14 lb a.i./A, a 7-day application interval, and a maximum of 3 applications). Even under the most vulnerable scenario for mammals (15g mammals foraging on short grass; see "Terrestrial Exposure Assessment") the RQ value is <0.01, a value an order of magnitude below the acute endangered species LOC of 0.1. In addition, the highest acute RQ of <0.03 for mammals, one Page 64 

### of 120 " Chronic risk estimates for birds arebased upon a nondefinitive NOAEC of <28.8 m&-diet (effects were seen at all tested concentrations) and all RQs are greater than the reported values. Until a discreteNOAEC is established for chronic/reproductive effects to birds, it is impossible to preclude chronic risk to birds feeding on any forage item under any exposure scenario. However, the RQs currently exceedingthe chronic LOC (id bold) have been identified separatelyhm those that are not currently exceeding but have the potential to until a definitiveNOAEC is. established. b~he chronicRQ meets or exceedsthe chronicrisk LOC (1) even based on the nonldeftnitiveNOAEC of Q8.8 mg a.i./kg diet. 0.14 0.16 0.16 0.14 0.14 0.125 0.12 0.1 0.08 7 14 21 14 14 30 30 14 7 3 2 2 3 2 2 2 2 2 52.44 44.55 40.86

. 39.85

38.98 30.59 29.37 27.85 26.89 >1.82~ >1.5Sb r1.42~ >1.3gb >1.3Sb >1.06~ >1.02~ >0.97 >0.93 24.03 20.42 18.73 18.26 17.87 14.02 13.46 12.76 12.32 >0.83 >0.71 >0.65 >0.63 >0.62 >0.49 >0.47 20.44 >0.43 29.50 25.06 22.99 22.41 21.93 17.21 16.52 15.66 15.12 r1.02~ >0.87 >O.80 >0.78 >0.76 >0.60 >0.57 >0.54 >0.53 3.28 2.78 2.55 2.49 2.44 1.91 1.84 1.74 1.68 >O.11 >0.10 >0.09 >0.09 >0.08 >0.07 >0.06 >0.06 >0.06that was based on a highly conservative estimateof dietary toxicity, is less than one-third the acute endangered species LOC of 0.1. Therefore, because no RQs exceeded the Agency's acute LOCs for mammals under this upper-bound exposure scenario, the acute mammalian RQs for all of the other scenarios are also below the Agency's LOCs and are not presented here. Although there were parental systemic, reproductive, and offspring effects at the LOAEC of 6000 mgkgdiet in the available 2-generation rat reproduction study, based upon the NOAEC of 1000mgkg-diet (NOAEL = 70.7 mgkg bwlday), the highest chronic mammalian RQ for the modeled upper-bound exposure scenario was 0.32 (TableIV.6). Because this RQ value calculated under the upper-bound exposure scenario is less than the Agency's chronicLOC 

### (I), the chronicRQs for all of the other scenarios are also below the Agency's LOCs and are not presented here.

c. Risks to Non-Target Terrestrial Invertebrates Dose-based Dietary-based

Currently, the Agency does not quantitativelyevaluate the potential exposure and risk of terrestrial invertebrates to pesticides for screening level assessments for non-endangered species. d. Risks to Non-Target Plants Inhabiting 

### Dry (Upland) and SemiAquatic (Wetland) Areas "The maximum exposure scenario was the pome hitscenario, with a maximum single applicationrate of 0.14 lb a.i./A, a 7dayapplication interval, and a maximum of 3 applications. b~~~s and toxicity values for the dose-based analysis are adjusted based on food intake and body weight differences so that they are comparable for a given weight class of animal.

A conservative estimate of dietary acute toxicity was generated using the existingrat oral LD50and assuming a conservative ingestionrate of 100 percent of the body weight. Theresulting estimated dietary acute toxicity endpointis >2000 m&-diet [(>2000 mgkg-bw)(l kg-bwllkg-diet)= 22000 mgkg-diet]. *Themost sensitiveLD50 and LCs0 values for mammals were non-definitive as they were determined to be greater thanthe highest tested levels in the available toxicity studies. Therefore, because all acute RQs are based on non-definitive toxicity values, theyrepresent conservative estimates of risk and are expressed with a '<' sign
. acute RQs are below the acute LOCs for non listed species (0.5), restricted use (0.2), and listed species (0.1). 'AUchronic RQs are below the chronic risk LOC (1). 35 1000 N/A

As discussed previously in the "Terrestrial Exposure Assessment" portion of the chapter, exposure and risks to upland and wetland plants was estimated using the TerrPlant (v1.2.2), a screeningmodel that estimates potential exposure from a single application using default assumptions for runoff and spray drift. Due to the low expected toxicity of spirotetramat to terrestrial plants, only the most conservative exposure scenario possible with TerrPlantwas modeled and presented in this assessment. Specifically, estimates were generated by assumingthat spirotetramatwas not ground incorporated, it was applied at the maximum single application rate for all uses (0.16 lb a.i/A) with aerial application methods (drift fraction = 0.05)' and that its solubilitywas greater than 100mg/L (solubilityfraction = 0.05; to account for higher levels of solubility for spirotetramat degradates). Page 65 of 

### 120 >3557 mglkg-bw >I538 mglkg-bw >2000 mgkg-diet 126mg/kg-bw 54 mglkg-bw 1000 mg/kg-diet 34.55 mgkg-bw 8.01 mag-bw 52.44 mglkg-diet <0.01 <0.01 <0.03 0.27 0.15 0.05A comparison of the most sensitive measures of effect fiom the available vegetative vigor and seedling emergence studies (summarized in Table 

### IU.11) to the estimated EECs for spirotetramat demonstratesthat all RQs for upland and wetland monocots and dicots adjacent to the application site, are below the listed and non-listed plant species LOC of 1.0 (Table W.7; the highest RQ was 0.55, roughly half of the Agency's LOC. Therefore, because no RQs exceededthe Agency's LOCs under the most conservative exposure scenario possible for spirotetramat using TerrPlant,the RQs for all of the other scenarios are also below the Agency's LOCs and are not presented here.



### B. Risk Description Aerial Spray Application, Unincorp .; 0.161b a.i./A

The risk hypothesis for this assessmentis that based on the mode of action of spirotetramat and the mobility/persistence of its major transformation products (spirotetramat-enol and spirotetramatketohydroxy), the use of spirotetramatin accordancewith label directions is expected to result in direct adverse effects on survival, growth, and reproduction ofboth terrestrial and aquatic organisms. However, the only findings of this baseline deterministic risk assessment that are consistent with this hypothesis are that chronic risk concerns have been triggered by avian RQs exceedingthe Agency's LOCs for birds and risk to some non-target invertebrates cannot be precluded. These concerns include risk to listed and nonlisted birds, reptiles, terrestrial-phase amphibians, and terrestrial invertebrates.

### In spite of the conservative nature of the exposuremodeling, no other acute or chronic RQ for any organism currently exceeds any of the Agency's LOCs.
Page 66 of 120 a EECs and RQs are based on the most conservativemodeling scenario possible for spirotetramat. Specifically,it was assumed that spirotetramat was not ground incorporated, it was applied at the maximum single applicationrate for alluses (0.16 lb a.i/A) with aerial application methods (drift ktion = 0.05), and that the solubilityis greaterthan 100mg/L (solubilityhction=0.05). Refer to "Exposure Characterization" section ofthe assessment for additional information.

The most sensitiveEC25 value from seedling emergence studies used to deriveRQs for non-listed plants in upland and wetland areaswas >0.16 lb a.i./A for both monocots and dicots. ' The most sensitiveNOAEC value hm seedling emergence studies used to deriveRQs for listed plants in upland and wetland areas was 0.16 lb a.i./A for both monocots and dicots. 

### * The most sensitiveECz5values from vegetativevigor studies used to deriveRQs for non-listed plants exposed to drift only were 0.06 and >0.16 lb a.i./A for monocots and dicots, respectively. The most sensitiveNOAEC values from vegetativevigor studies used to derive RQs for listed plants exposed to drift only were 0.02 and >0.16 lb a.i./A for monocots and dicots, respectively. Monocot

Dicot 0.016 <0.1

<O. 1 0.1

0.1 0.088 <0.55

<0.55 0.55

0.55 0.008 0.13

<0.1 0.40

<0.1

### Spirotetramat is a systemic broad spectrumtetrarnic acid insecticide (ketoenole) capable of translocation within plants following infiltration of leaves and root systems (xylem and phloem mobile), that is to be applied as a preventative treatment only when sufficient leaf tissues are present for uptake and translocation to occur. Although there are two possible stereoisomers of spirotetrarnat, cis- and transisomers (ratio of -98:2), the cis-isomer is the active one serving as a lipid biosynthesis inhibitor (LBI) 

### in chewing insects (e.g., aphids, whiteflies, scales, mealy bugs, Psylla, Phylloxera,thrips, and mites). Three products containing spirotetramat,MoventoTM SC (suspension concentrate),UltorTMSC (suspension concentrate), and PYI 

### 8330 OD (oil dispersion), are proposed for use on crops such as citrus hits, grapes and small fruit climbing, pome hits, stone hits,tree nuts plus pistachio, hops, Christmas trees, cucurbit vegetables, hitingvegetables plus okra, leafy vegetables, brassica (cole) leafy vegetables, and potatoes and other tuberous and corm vegetables. For both aquatic and terrestrial ecosystems, one major route of exposure to spirotetramatis direct deposition of off-target spraydrift. The potential sources and mechanisms ofrelease as a spray include conventionalground sprayers, airblast equipment, rotary wing aircrafts, or sprinkler-type chemigation methods. Once present in these systems, volatilization of spirotetramatfrom soil or water is unlikely to be a significant route of dissipation (vapor pressure of 4.2~10-" mm Hg (20°C) and Henry's Law constant of 6.90~10-l3 ~tm-m3/mol at pH 7 and 20 "C). Based on laboratory soil metabolism, outdoor metabolism, and terrestrial field dissipation studies, once in the terrestrialenvironment, the major route(s) of dissipation for spirotetramatare degradation to spirotetramat-en01 and spirotetramat-ketohydroxy(thetwo major transformation products (>lo%) in the aerobic soil metabolism studies) and mineralization to C02. 

### In addition, there is rapid formation of high levels of non-extracted residues in soil. One of spirotetramat's major transformation products, spirotetramat-enol, is the product of the hydrolytic cleavage of the ester bond in the parent (theoretically a stoichiometric conversion). Once formed, spirotetramat-en01is then firther oxidized at the benzylic carbon in aerobic environmentsto yield the other major metabolite, spirotetramat-ketohydroxy(maximum 24.0% in the aerobic soil metabolism study). 

### In addition to spraydrift, 

### given their moderate to high solubility, relatively low level of binding, and low tendencyto bioaccumulate/bioconcentrate, 

### spirotetramat (solubility = 

### 29.9 mgL at pH 7; hc= 289 ml/goc; &,~324), spirotetramat-en01(solubility =2,700 mgL at pH 7; hc= 55 

### mL/goc; &~2. I), 

### and spirotetramat-ketohydroxy(solubility =228 mgL at pH 5.7; I&= 65.3 mI,/goc; G~20) are considered moderately to highly mobile and could be potentially transported to adjacent bodies of water via surface runoff from rain events. Although susceptibility of a wide range of aquatic environments to runoff is dictatedby numerous varying factors including topography, irrigation, and regional meteorological patterns, spirotetramat and spirotetramat-en01generally should only be available for runoff or leaching in substantialamounts up to a few days after application due to their relatively low persistence in aerobic soils (DTS0<l day), except in vulnerable soils with low pH and low microbial populations. On the other hand, although spirotetramat-ketohydroxy 

### may be available for leaching into groundwater and runoff to surface water for weeks or months after application accordingto aerobic soil metabolism studies @T50116.7days), it was observed in much lower amounts (24.0% of the applied at 1 DAT). Once in aquatic environments, important routes of degradation1 transformation for spirotetramatinclude hydrolysis 

### in alkaline media (DTS0 =

### 0.32 days at pH 9), photolysis in natural water (DTS0 =

### 0.74 Phoenix, AZ 

### days) and biodegradation in 

### anaerobic environments(DTS0 52.8 

### days). In 

### addition, under aerobic aquatic conditions, spirotetramat was mostly associatedwith the aqueous phase and rapidly degraded with a calculated DTS0 of <ldayin the total system. The major transformation products in the aerobic aquatic metabolism study, spirotetramat-en01and spirotetramat-ketohydroxy, 

### were much more persistent than the Page 67 of 

### 120parent under the same conditions (DT5O= 37.9-59.0 days for spirotetramat-en01and appeared to be stable for 

### spirotetramat-ketohydroxy). Spirotetramat, spirotetramat-enol, and 

### spirotetramat-ketohydroxy are the chemicals of concern based on the amount of the applied observed in the studies andlor persistence. 

### In addition, in the soil studies, high levels of non-extracted residues were observed (up to around 60% of the applied). Since the registrant did not prove otherwise, these residues were assumed to be bioaccessible (i.e. the non-extracted residues were assumed to be persistent compounds). 

### In developingthe half-lives for the total residues of concern, all, spirotetramat, spirotetramat-enol,

### spirotetramat-ketohydroxyand the non-extracted residues were considered toguether. The aerobic soil half-lives ranged from 161-204days (mean 184 days); while the aerobic aquaticmetabolism half-lives ranged hom 141-693 days (mean 364 days). These values indicate high persistence of the total residues of spirotetramat. Although both spirotetramat-en01and 

### spirotetramat-ketohydroxyappear to be less toxic than parent based on acute toxicity testing with aquatic receptors despite retaining the basic backbone structure of the parent, this assessment conservativelyassumed equivalent toxicity among 

### them and included the two transformation products in exposure modeling and subsequent risk calculations.The potential presence of these major metabolites was accounted for because they may be of concern in soils, sediments, and water due to their high concentrations in the laboratory studies (spirotetramat-enol) and their persistence relative to the parent 

### (spirotetramat-ketohydroxy). 1. Risks to Non-Target Aquatic Organisms Almost all of the available aquatic toxicity data for the metabolites on all tested species indicate that the parent is more toxic than any of the degradatesby at least an order of magnitude. The only data suggesting otherwise, are the studies with duckweed, in which the parent (EC5~=4.49 mg a.i./L, LOAEC=6.06 mg a.i./L) and spirotetramat-en01 (EC5~=5.4 mg a.i./L; LOAEC=3.05 mg a.i./L) appearto be close in terms of relative toxicity. However, even assumingthe parent and degradates are of equivalent toxicity, based on the EECs for total residues (spirotetramat f spirotetramat-en01 

### + spirotetramat-ketohydroxy)generated using the Tier 2 aquatic model PRZMIEXAMS and the most conservative exposure scenario available (NC apple aerial application scenario), concerns for aquatic animals and plants are not triggered by any acute or chronicRQ. Therefore, the conclusion of this risk assessment is that the best available information currently indicates that risks of direct effects to all listed and non-listed aquatic organisms are below the Agency's screening levels of concern. However, there are a number of causes of uncertainty regarding the aquatic risk assessment for spirotetramat. First, there is uncertainty surroundingthe conduct of almost the entire suite of aquatic studies. 

### In all studies using the technical grade active ingredient, in both those that did and did not test above the limit of solubility of spirotetramat(29.9 mg a.i./L), the maximum allowable amount of solvent under US EPA guidelines was used. This indicates that there is adequate reason to believe that it was not possible to achieve the stated water solubility under test conditions.

### In such instances, the US EPA "requires conventional centrifugation for all test media.. .whereverthe solubility and hence bioavailability are in question" (US EPA Pesticide Reregistration Rejection Rate Analysis handbook, Appendix A, p. 10). Therefore, because there has been no indication that measured concentrationsin any of the aquatic studies were based on centrifuged supernatant, there is uncertainty regardingthe amount of spirotetramat bioavailableto the test organisms and all estimates of toxicity for aquatic organisms. However, 

### in agreement with international governmental partners associatedwith registration efforts for this pesticide, ecological effects data evaluation and approval responsibilities are being met through the efforts of the Page 68 of 

### 120

### Austrian Agency for Health and Food Safety (AGES). The Agency is using the results of the AGES review as they appear in Volume 3, Annex B.9: Ecotoxicology monograph for registration in Europe. In 

### addition to the general uncertainty regarding toxicity estimates, aquatic EECs could be an underestimation of actual exposureconcentrationsin the environment. Although the label stated that spirotetramat can be appliedvia foliar spray application up to 2 to 3 times per season depending on the crop, for this risk assessment, EFED assumed that spirotetramat was applied at a maximum of 2 to 3 

### times per year. Therefore, exposureestimates and risk to aquatic organisms could be significantly underestimated for crops such as leafy, brassica, and fruiting vegetables in CAY AZ, FL, GA, LA, NC, TX, andlor SC, for which there are more than one growing season within a singleyear. Another cause of uncertainty for the aquatic assessment is that chronic data were only available for the fathead minnow and water fleas, yet rainbow trout and midges were more acutely sensitive members of the freshwater fish and invertebrate taxonomic groups, respectively. Although ordinarilyin this instance acute-to-chronicratios would be used to derive chronic toxicity estimates for the most acutely sensitive organisms, it could not be done due to the lack of a defkitive acute toxicity endpoint for the water flea (LCSo>50 mg a.i./L) and an acutetoxicity endpoint for fathead minnows. However, by examining the predicted 60-day (0.0108 mg a.i./L) and 21-day (0.01 11mg a.i./L) EECs for totalresidues and the most sensitivechronic toxicity endpoints available for freshwater fish (fatheadminnow NOAEC=0.534 mg a.i./L) and invertebrates (water flea NOAEC=2 mg a.i./L), one can see that rainbow trout and midges would have to be approximately49 and 180times more sensitive than fathead minnow and water fleas on a chronic basis, respectively, in order to trigger exceedancesof the Agency's chronic level of concern (1). Based on predicted 60-day (0.0000563 mg a.i./L) and 21-day (0.000154 mg a.i./L) EECs for parent-only residues, rainbow trout and midges would have to be approximately9485 and 12987times more sensitive than fathead minnow and water fleas, respectively, in order to trigger exceedances of the Agency's chronic level of concern (1). Therefore, the issue is whether it is reasonable to expect such a significantly heightened sensitivity of rainbow trout and midges on a chronicbasis. For freshwater fish, based on part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticide products, if the speciesused in an early-life stage toxicity test is different from the two species used for the acute toxicity tests, an additional 96-hour LC50 on the species tested in the early-life stage studymust be submitted. Because these conditions apply to spirotetramat, an additional acute 96-hour toxicity test with fathead minnows (guideline 850.1075) will be requested to fill this data gap. Once these data are available and are evaluated appropriately,

### an acute-to-chronic ratio can be applied as described aboveto re-evaluate chronic risk estimates for freshwater fish. For invertebrates, a 28-day studywith midges has been submitted; however, the design of the study deviates significantlyfrom what would be required under part 158 of Title 40 in 

### the U.S. Code of Federal Regulations. Specifically, while the studywas conducted in 

### the presence of sediment,the water column was spiked once, equilibrium between the water column, pore water, and sedimentwas not achieved, and test concentrations dropped rapidly. In addition, concentrationswere only measured in 

### pore water and overlying water at the lowest, middle, and highest test level (there were seven test concentrations and a control), and at an inappropriate time interval (on Days 0,7, and 28) for a parent compoundthat is expectedto degraderapidly in water. While initial measured concentrationsin overlying water were close to nominal, concentrations at the other time intervals were less than the limit of quantification (LOQ) in all test levels except the highest, where they were <2% of nominal. In 

### addition, test concentrationsin 

### pore water were less than the LOQ at all time intervals in all test levels exceptthe highest, where the concentration peaked at 0.3% of nominal. Therefore, the applicability of the study and its NOAEC within
Page 69 of 120

### the context of EFED's standard screening level approach in assessing chronic risk to invertebrates is uncertain. Given the nature of the exposure (appears to be acute exposurein the water column) and the effects (appear to be long-term reproductive effects; emergence and development) in the spiked-water study, and the limited amount of spirotetramatand its major degradates expectedto be associated with sediment (low 

### Koc and Kow

### values), it appears that while the presence of sediment in the study is necessary for evaluating the sensitive critical life stages, it is likely that it is the acute exposure in water that is driving the toxicity of these organisms. In 

### addition, based on acute studies with midges (Chivonomusriparius), both spirotetramat-en01 (ECS0=74.9 mg a.i./L; LOAEC=16 mg a.i./L based on 13%mortality) and spirotetramat-ketohydroxy 

### (ECS+lOO mg a.i./L, LOAEC-4 mg a.i./L based on 5% mortality) are less acutely toxic than the parent (EC50=0.66mg a.i./L; LOAEC< 0.32 based on 10%mortality), and it would appear to be more appropriate to use the parent-only EECs for evaluating risk to these organisms. Therefore, for a conservativeyet reasonable screeninglevel risk assessment, given the nature of the exposure in the study (single water column spike in the presence of sediment after which concentrations in all compartments dropped rapidly; short-term exposure primarily via water column), the expected nature of the exposure of these organisms in the environment, and the lower toxicity of the degradates as compared to the parent, the NOAEC fi-omthe studybased on initial nominal concentrationsin overlying water (NOAEC=O.1 mg a.i./L based on reduced emergence) is most directly comparableto peak EECs in the water column derived using a parent-only approach. A comparison of the peak parent-only water column EEC (EEC=0.000573 mg a.i./L) with the NOAEC of 0.1 mg a.i./L results in a theoretical RQ of 0.00573, which is 175 times less than the chronic LOC (1). If a chronic 28-day studywith midges were conducted again using constant water column concentrations (maintained using a flow-through design) in the presence of sediment (to enable the completion of their life-cycle and observation of anyreproductive effects), the resultant toxicity value would be compared to the 21-day parent-onlyEEC in the water column (0.000154 mg a.i./L) and would have to be -650 times higher than the currentNOAEC in order to trigger any chronic concerns for this taxonomic group. Despite the uncertainties associated with the toxicity estimates, it appearsthat risk of long-term reproductive effects to these organisms appears to be low and additional sediment data will not be requested. 

### In addition, based on spirotetramat's chemical characteristics (spirotetramat's maximum Kd 

### is 5.52, its log 

### Kw is -2.5, its maximum 

### K, is 437, its aerobic soil metabolism half-life is <lday, and its maximum aerobic and anaerobic aquatic metabolism half-lives are 0.9 and 2.8 days, respectively),the need for conditionally required acute or chronic sediment toxicity data is not be triggered for the US EPA under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticide products. Lastly, there were no chronic data available for estuarinelmarine invertebrates and fish. Chronic toxicity data for estuarinelrnarine invertebrateswould be conditionally required under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional pesticide products since the most sensitive acute ECS0 is <lmglL and the highest estimated environmental concentration (EEC) in water is 2 

### 0.01 of the acute ECS0.However, these toxicity estimates are based on toxicity to the eastern oyster, yet the chronic life-cycle studywith estuarinelrnarine invertebratesis conductedwith mysids. Based on mysid toxicity data, these requirements would not be met. 

### In addition, acute toxicity studies suggestthat fi-eshwaterand estuarinelmarine organisms are equally sensitive to spirotetramat, and currently there are no risk concerns for freshwater fish and invertebrates. Therefore, althoughthe value of the study in this present risk assessment is low, the study is being held in reserve pending a request for new use patterns. 2. Risks to Non-Target Terrestrial Organisms
Page 70 of 

### 120a. Non-Target Birds and Mammals 

### Based on the best available information kd terrestrial exposuremodeling with T-REX, the only concerns that the Agency has with respect to risk to terrestrial vertebrates resulting fiom the proposed use patterns for spirotetramat are those triggered by avian chronic RQs that exceed the Agency's screening levels of concern. This concern includes risk to listed and non-listed birds, reptiles, and terrestrial-phase amphibians. However, in spite of the use of upper-bound EECs for total residues for the most conservative modeled exposure scenario, all other RQ values for acute risk to birds, and acute and chronic risk to mammals, fallbelow the Agency's LOCs. Currently there is insufficient evidence for mammals and birds to discountthe conclusions derived based on the total residues approach. The acute toxicity data for mammals (all LDS0 values for the parent and degradates are >2000 mgkg-bw) suggests that both the parent and the major degradates are practically non-toxic. A testicular/spermtoxicity studythat was conducted with spirotetramat-en01and reviewed by the Office of PesticideProgram's Health Effects Division, revealed toxic effects in rats at 800 mgkg-bw (the only dose level tested). Similar effects were induced by exposure to the parent at both higher and lower levels, suggesting that the toxicity of spirotetramat-en01is of equivalent or lower toxicity than the parent. Lastly, there were two mutagenic studies available, one with spirotetramat and one with spirotetramat-ketohydroxy; both were negative. No other data are available to evaluatethe relative toxicity of the degradates to the parent for terrestrial vertebrates. Despitethe inadequacy of the toxicity data to support one modeling approach or another, the overall risk conclusions do not appear to be highly dependent on the choice. Although the magnitude ofrisk values is influenced, the magnitude of risk remains unchanged and results ofboth the parent-only and total-residue approachyield the same interpretation of risk (the same LOC exceedances)in all but one instance (specifiedbelow). With regards to acute risk estimates for birds, there are two sources of uncertainty. First, although the quail LDS0 of >2000 mgkg-bw was used to generate acute oral risk quotients,the mallard LCs0 of >6050 mg/kgdiet, and the average body weight and daily feed consumption of the mallards at the highest test level 

### in the sub-acute dietary study, can be used to express the dietary toxicity endpoint 

### in terms of daily dose equivalents (>475 mgkg-bw). If this estimate and the averagebody weight of the birds is used in 

### T-REX to generate acute oral risk estimates of mortality to birds for characterization purposes only, then there is indication that there is some possibility of acute mortality to 20g birds feeding on short grass for some of the exposure scenarios based on both parent-only and total residues (maximumtheoretical RQ= <0.17 for the pome hitscenario; potential exceedance of the endangered speciesLOC (0.1)). However, the fact that the highest RQ estimated using this approach isnon-definitive and is less than the reported value (with no observed mortalities), taken in conjunctionwith an LDS0 of >2000 mgkg-bw established for quail in the only acute oral toxicity studyavailable, suggeststhat the overall potential for acute mortality ofbirds resulting fiom spirotetramatuse is likely low. The other uncertaintyis that although risk of acute mortality to avian species appears to be low, there is some indicationof potential for risk of acute sub-lethal effects to birds. 

### In order to evaluate potential sublethal effects associated with acute exposure to spirotetramat, the lowest spirotetramat concentration where statisticallysignificant sub-lethal effects were observed in an acute study (NOAEC<344mglkg-diet; significantlydecreasedbody weight at all treatment levels in the sub-acute dietary toxicity study) was compared to dietary-basedEECs. This comparison revealed that the highest estimated upper-bound EEC for birds that consume short grass based on the total residues approach was about 15 percent of this estimated NOAEC. Although risk of sub-lethal effects to birds may be significantly higher than risk of Page 71 of 

### 120
\mortality because body weight effects are observed at much lower concentrationsof spirotetramat (lowest NOAEC <344 mgkg-diet vs. lowest LCS0>5000 mg/kg-diet ), it is unclear how these effects would impact the birds7 abilityto survive, forage, reproduce, care for their young, and escape from predators in the environment. 

### In addition, it is difficult to determine whether the observed effects in the sub-acute dietary study were a result of the birds being too sick to eat, whether they werejust avoiding the food due to contamination, or whether the mode of action (MoA; lipid biosynthesis inhibitor) prevented them from adding bodyweight throughout the duration of the study. However, the observed decrease in the body weight of the birds in the acute oral toxicity study despite the availability of clean feed, suggeststhat neither toxic anorexia nor the decreased ability of the birds to add weight due to the MoA cannot be ruled out. As mentioned previously, it must be noted that chronic risk estimates for birds are based upon a nondefmitive NOAEC of <28.8 mg/kg-diet (adverse reproductive effects were observed at the lowest tested concentration in the available avian reproduction study with mallards) and all RQs are greater than the reported values. Therefore, there is uncertainty with respect to their estimated magnitude and there remains the potential for additional chronic LOC exceedancesbeyond those that have been definitively identified (Table 

### IV.5). Until a discrete NOAEC is established for chronic/reproductiveeffects to birds, it is impossible to preclude the potential for chronic risk to birds feeding on any forage item under any exposure scenario. 

### In addition, even based on the current non-defmtiveNOAEC, dietary-based chronic RQs for avian species feeding on short grass meet or exceed the chronic risk LOC for all but two of the evaluated crop use scenarios for both the parent-only (RQ range = >0.82 to >1SO) and total residues approaches (RQ range = >0.93 to >1.82), as does the RQ for birds feeding on broadleafplants/small insects under the pome hitscenario when using the total residue approach (RQ = >1.02). To bound the current estimates of risk to birds feeding on short grass (the forage item that results in the highest exposure of spirotetramat to birds), RQs using mean Kenaga residue values rather than upperbound values were calculated for all modeled exposure scenarios using both the parent-only and total residues approaches. Using the non-conservativemean residue values, implying that higher predicted residue values are expected half the time, RQs ranged from >0.29 to >0.53 for the parent-only approach, and from >0.33 to >Oh4 for the total residues approach. However, two things shouldbe noted. First, all RQs are greater than the reported value so potential chronic LOC exceedances cannot be precluded until a definitiveNOAEC is established. Second, using the mean Kenaga residue values for calculating RQs would not protect birds and mammals that consume food items that have residues on the higher end of the residue distribution. 

### An analysis of the residue distribution for the different food items using input values from Fletcher et al. 

### (1994) and assuming a log-normal distribution of residues on food items shows that the mean Kenaga values range from about the 62-87 percentile indicating that up to 38% of the higher-end food item residue estimates are not captured by using the mean Kenaga values. 

### In contrast, for the upperend Kenaga residue estimates, about 3-13% of the upper-end residue estimateswere not captured. This highlights the fact that the upper-end Kenaga values are not a maximum exposure level. The estimated upper-bound dietary-based EEC for total residues (52.44 mglkg-diet ) on short grass under the most conservative exposure scenario considered in this risk assessment (thepome fruit scenario; maximum single application rate of 0.14 lb a.i./A, a 7-day application interval, and a maximum of 3 applications)is >1.82 times higher 

### than the most sensitiveNOAEC. Based on this scenario,the maximum spirotetramat application rate allowed on the label would have to be reduced by 

### at 

### least 45% in order to ensure that all of the chronic RQ values based on the most sensitiveNOAEC are less than the chronic LOCs for all birds. However, since there is uncertaintywith respect to the estimated magnitude of RQs (all RQs are greater than the reported values), the definitiverate reduction needed to lower all RQs below the LOCs cannot be identified until a defmitiveNOAEC is established for chronic/reproductiveeffects to Page 72 

### of 120birds. A closer look at the most sensitiveNOAEC value of <28.8 mgkg-diet (LOAEC = 28.8 mag-diet) with which chronic avian RQs were calculated, reveals that it was based on a -6.58% reduction in mean hatchlingbodyweight at the lowest test level. Although no other statistically significant effects were observed at the 28.8 mg/kg-diet test level, other affectedendpoints with a NOAEC of 28.8 mgkg-diet (LOAEC = 78.8 mglkg-diet ) include # of hatchlings of live 3-week embryos (520%), # of 14-dayold survivorsof eggs set (517%), # of 14-daysurvivors per hen (538%), # eggs laid per hen (434%), # of eggs set (533%), and # of eggs hatched (536%). While the use of the 28.8 mgkg-diet for risk assessment purposes appears to be reasonable and defensible based on the magnitude of all the observed effects at 78.8 mg/kg-diet, it could be debated whether the most sensitiveNOAEC for the studyis truly less than 28.8 mgkg-diet and whether a request for an additional avian reproduction studyis warranted based on a 6.58% reduction in hatchling bodyweight at this test concentration. To evaluate this further, the minimum significant difference detectable in this studyfor hatchlingbodyweight was calculated, and it corresponded to roughly a 5.78% reduction from the control group. Given that there is less than a one percent differencebetween the effect level at the NOAEC in the study and the minimum significant difference for this endpoint, the value added by having an additional study conducted on the basis of this reduction alone does not appear to be substantial. Conversely, although no additional statistically significant effects were observed at this test level, large reductions in other

### frank effects that were observed at 28.8 mg/kg-diet included reductions in # of 14-day survivors (522%), # of viable 14-dayembryos (J18%), # of live embryos (518%), 

### and # of eggs hatched (522%). Due to the degree of these reductions, it is hard to indicate that these effects are not biologically significant and are considered meaningful. Thus, because of the extent of these observed effects at the lowest tested level, it is reasonable to assume they are significantbiologically, 

### and may warrant the request for an additional avian reproduction study. 

### In addition, at the 78.8 mgkg-diet treatment level, there were effect levelsup to 3 1 % for some endpoints that were not detected as being statistically significantusing either Williams' or Dunnett's tests (e.g., 531% viable embryo (Dayl4) and /3 1% live embryo (Day2l)), and effect levels up to 38% for some endpoints that were not detected as being statistically significant using Dunnett's tests (e.g., 438% hatching survival (Dayl4), 536% #hatched, 533% eggs set, and 534% eggs laid). Therefore, the abilityof this study to detect what could be considered to be ecologically relevant endpoints appears to be limited, and reliance on statistical significance alone could be problematic for interpretation of spirotetramat's risk picture with respect to chronic/reproductiveeffects to avian species. 

### In particular, a calculation of the 

### minimum significant difference for # of 14-day old survivors reveals that anything less than a 35% reduction fiom the control group could not be captured as statistically significant. Subsequently, a curve fitting approach was used to estimate a minimal effect level for the endpoint, # of 14-day old survivors, to explore the possible impacts on risk estimates strictly for characterization purposes. The Benchmark Dose Approach (BMD; US EPA, 2006) was used to fit toxicity data and then estimateto 5, 10, and 15%effect levels, which represent a range of effect levels that likely overlap where ecologically significant effects may be expected to occur. The endpoint chosen for this analysis was the # of 14-day old survivors because it was the one that showed the largest effect level (522%) of those endpoints at the lowest test concentration (28.8 mglkg-diet ) that were not determined to be statistically reduced as compared to the control using either Williams' or Dunnett's tests. The BMD soffware allows the choice of several models; in this case the linear model was the simplest model that had the best fit and appearedto model the data adequately. The linear model generated 5, 10, and 15%effect levels of 8.3, 16.5, and 24.8 mag-diet, respectively. The estimated concentrations that correspondedto the effect Page 73 of 120

### levels were then used to estimate potential risk with 

### T-REX. The result was a range of theoretical chronic RQs for birds feeding on various food items for all modeled exposure scenarios (Table IV.8). Taken as a whole, the results from this exercise indicate that the use of effect levels that may be considered closer to the threshold of ecological relevance result in RQs roughly 1.2 to 3.5 times higher than RQs calculated based on the NOAEC from the avian reproduction study for this endpoint (# 

### of 14-dayold survivors; 28.8 mgkg-diet ). 

### Previously, based on the NOAEC of 28.8 mglkg-diet, onlyRQs for birds feeding on short grass, and one other RQ, for birds feeding on broadleaf plants/small insects under the pome fruit scenario when using the total residue approach, exceededthe chronic risk LOC. However, based on this exercise, there is the potential for chronic risk LOC exceedances for birds feeding on short grass, tall grass, and broadleafplants/small insects for both the parent-onlyand total residues approach, depending on the chosen effects level (Table IV.8). 

### However, there still are no exceedances of the chronic risk LOC for birds feeding on fruits/pods/seeds/largeinsects based on either residue approach or on any effects level (overall RQ range=0.06 to 0.39). With regards to potential exceedances, RQs for birds feeding on short grass ranged from 1.08 (15% effect level for the least conservative modeled exposure scenario, cucurbits) to 6.32 (5% effect level for the most conservative modeled exposure scenario,pome fruit) for total residues, and from 0.95 (15% effect level for the least conservative modeled exposure scenario, cucurbits) to 5.19 (5% effect level for the most conservative modeled exposure scenario, pome fruit) for parent-only residues. RQs for birds feeding on tall grass ranged from 0.5 (15% effect level, cucurbits) to 2.90 (5% effect level, pome fruit) for total residues, and from 0.44 (15% effect level, cucurbits) to 2.38 (5% effect level, pome fruit) for parent-only residues. RQs for birds feeding on broadleafplants/small insects ranged from 0.61 (15% effect level, cucurbits) to 3.55 (5% effect level, pome hit)for total residues, and from 0.54 (15% effect level, cucurbits) to 2.92 (5% effect level, pome fruit) for parent-onlyresidues. For the previouslydiscussed endpoint, hatchling bodyweight, a less drastic reduction compared to control (J6-7%) was observed, but was found to be statistically significant.For that effect, ecologically relevant effect levels are likely to correspond closelywith the statistically significant experimentalLOAEC (28.8 mglkg-diet). However, ecologically and statistically significant levels do not appear to correspond'as closely for some of the other endpoints, such as the one considered more closely here, # 

### of 14-dayold survivors. Although the results from this exercise would be more robust if 

### an ecologically significant effect level had been identified or established, they suggest that species ofbirds that rely on a high reproductive rate for population sustainabilitymay be the most susceptible to the effects of spirotetramat.

Page 74 

### of 120

### In addition to the uncertainty regarding the reproductiveNOAEC for birds, there are three major uncertainties associated with the predicted EECs for terrestrial vertebrates. First, as for aquatic EECs, terrestrial EECs were estimatedby assuming that spirotetramatwas applied at a maximum of 

### 3 times per year, despite that the proposed labels allow for up to 3 applicationsper season. 

### In order to evaluate the affect of this assumption on the overall conclusions of the risk assessment with respect to terrestrial vertebrates, T-REX was run in an exploratorymanner to conservatively estimate upper-bound total and parent-only EECs for all the exposure scenarios considered in this assessment by assumingthat spirotetramat couldbe applied up to 9 times a year (based on a conservative estimate of 3 applications in 3 growing seasons for all crops within a single year) at the label-recommended interval and maximum single applicationrate. Based on this analysis, although the EECs and RQs increased slightly in magnitude, there were stillno acute or chronic risk concerns for mammals, or acute risk concerns for birds. 

### In addition, no additionalRQs for chronic risk to birds that had not already exceeded the chronic LOC were increased to point that would trigger Agency concerns, due to the short foliar half-life estimated for spirotetramat. As a point of reference, for the pome fruit exposure scenario (the one with the highest estimated exposure to terrestrialvertebrates, the second highest application rate, and shortest interval), RQs based on total residues for birds that feed on short grass, tall grass, broadleaf plants/small insects, and fruits/pods/seeds/large insects, increased from >1.82 to >1.94,>0.83 to >0.89, >1.02 to >1.09, and >0.11 to >0.12, respectively. The second uncertainty associated with the terrestrial EECs predicted using 

### T-REX is that the model was 

### runfor agricultural uses with the maximum single application rate and number of applications as proposed on the label, despite that in some instances this approach resulted in a minimal exceedance of the maximum label-recommended seasonal applicationrate. Specifically, the maximum label-recommended seasonal application rates of 0.34 (vs. modeled 0.42), 0.2 (vs. modeled 0.25), 0.2 (vs. modeled 0.24), 0.4 (vs. modeled 0.42), and 0.24 (vs. modeled 0.28) lb a.i./A for the use of spirotetramaton tree nuts, grapes, grape and small vine-climbing fruits, pome fruits, and stone fruits, respectively, are all below the modeled seasonal rates. However, this approach was taken in order to be as conservativeas possible; 

### T-REX has no current provisions that allow for an automated process by which to vary application rates within a given season or year, and using an applicationrate estimated by dividing the maximum seasonal application rate by the maximum number of applications would result in an underestimate ofpredicted peak residues. However, for characterization purposes only, an application rate estimatedby dividingthe maximum seasonal application rate by the maximum number of applications for each of the affected exposure scenarioswas used in order to evaluate how the magnitude of RQs would change 

### if a less conservative approach were taken. Only chronic RQs for birds feeding on short grass were derived for this exploratory analysis since this is currently the Agency's primary area of concern with respect to risks to terrestrial vertebrates based on the available data. Based on this approach,RQs based on total residues for tree nuts, grapes, climbingfruits, pome fruit, and stone hitsdropped fiom >1.35 to >1.12, >1.06 to >0.85, >1.02 to >0.85, >1.82 to >1.69, and >1.35 to >1.16, respectively. RQs based on parent-only residues for tree nuts, grapes, climbing fruits,pome fruit, and stone fruits dropped fiom >1.23 to >0.99, >1.04 to >0.83, >1.00 to >0.83, >1.50 to >1.39, and >1.23 to >1.05, respectively. Therefore, even based on this less conservative approach, some chronic risk concerns for avian species feeding on short grass are still triggered for both the parent-only and total residues approachesby chronic LOC (1) exceedances. 0.10 to 0.20 0.07 to 0.13

Page 75 

### of 120 a Upper-bound residues calculatedusing T-REX model (T-REX, Version 1.3.1,datedDecember7,2006).

5, 10, and 15%effectlevels correspond to concentxations of 8.3, 16.5,and 24.8 mgkg-diet ,as estimated using The BenchmarkDose Approach (BMD; US EPA, 2006). 0.92 to 1.79 0.61 to 1.19 0.75 to 1.46 0.50 to 0.97 10 15 1.63 to 3.18 1.08to 2.1 1Lastly, the Kenaga nomogram is used by 

### T-REX to predict residue levels on dietary items present on Day 0 following different application rates of a chemical to different categories of plants or plants parts; however, it does not appear to account for the systemic nature of spirotetramatin plants and the uptake from soil via root systems over time. Subsequently, estimates of risks to terrestrial vertebrates feeding on various plant forage items over time following spirotetramat applicationsmay be underestimated. However, as mentioned previously, spirotetramatis to be applied as a preventative treatment only when sufficient leaf tissues are present for uptake and translocation to occur; thus, the effectivenessof this compound in protecting agricultural crops appears to be largely dependentupon efficient and accurate application to leaves, and the amount of the compound in the soil versus what is initiallyin/on plants is expected to be low. 

### In addition, given the expected short half-life idon plants based on the magnitude ofresidue studies, the short residence time of the parent and spirotetramat-en01 in soil (based on laboratory soil metabolism, outdoor metabolism, and terrestrial field dissipation studies), and the relatively lower amount of spirotetramat ketohydroxy expected to be present in soil, the relative contribution of uptake from roots over a period of time beyond the initial application versus to the overall residues in plants is also expected to low.
c. Non-Target Terrestrial Invertebrates Currently, the Agency does not quantitatively evaluatethe potential exposure and risk of terrestrial invertebratesto pesticides for screening level assessments for non-endangered species. Risk estimates for terrestrial invertebrates would be complicated by the complex and varied lifehistories of these types of organisms, and a lack of data on exposurepathways. The risk characterizationfor terrestrial invertebrates that follows below is based solely on available toxicity data. Honev Bees Although some toxic effects, including 2-4% mortality, were observed at the limit dose in the acute oral and contacttoxicity tests with honey bees, spirotetramat technical grade active ingredient (TGAI) is classified as practically non-toxic with the LDso values established as >107.3 pg a.i./bee and >lo0 pg a.i./bee, respectively. 

### In addition, according to other acute toxicity studies, a spirotetramat formulation (Spirotetrarnat OD 150) is also classified as practically non-toxic to bees with acute oral and contact LDS0 values established as 91.7 pg a.i./beeand 162.0 pg a.i./bee, respectively. Although the intrinsic hazard potential to bees based on the acute oral and contact studies appears to be low, brood feeding tests where BY108330 100 OD and BY108330 240 SC were fed to bee colonies in a pure liquid sucrose solution containing 0.0144% a.i. (1371 mg product per colony) suggest otherwise. 

### In these tests, significant brood effects including increased mortalityin adults and pupae, massive perturbation of brood development, and early brood termination were detected. 

### In addition, a semi-field brood test was conductedwith a representative formulation (l3YI08330 100 OD) in a representativemodel crop, oil-seed spring rape (Brassica napus). 

### In this study, three pre-flowering applicationsat 0.064 lb a.i./A followedby two applications at 0.086 lb a.i./A were made to a blooming floweringbee-attractive crop during bee flight. Based on this study, no treatment-related effects to bee brood and colony development were found. Likewise, no effects to other endpoints, as adult mortality, foraging activity, or bee behavior were detected. Another field studywas conducted with BY108330 150 OD and the honey bee (Apis mellifera L.) in the Valenciaregion of Spain. In one field, BYI08330 150 OD was applied at rate of 0.064 lb a.i./A at a 7-day interval on the crop, Phacelia tanacetifolia,two times before flowering (no bees in the field) and two times during flowering and foraging activity of the bees. 

### In the second field the applications were carried out two Page 76 of 

### 120times during flowering and foraging activity of the bees at an applicationrate each of 0.086 lb a.i./A and a 7-day interval. Based on this study, neither treatment fields revealed an adverse effect on honey bee mortality, flight intensity, behavior, colony strength, or brood size. Lastly, aspart of its agricultural development (AD) and stewardshipprogram, Bayer Cropscience AG has also conducted trials with spirotetramat to evaluate its pollinator compatibility. These trials were not conducted under GLP and formal reports were not preppred, but some data were submittedunder 

### FIFRA 6(a)(2). The data collected under these experimental conditionsmay exaggerate exposure and are not necessarily representative of populations ofbees because the test subjects were confined in tentsltunnels and forced to forage exclusively on treated plants, despite that bees generally forage farther then the study allowed. However, all of the trials were conducted at use rates similar to those proposed for field use in the USA (0.032 -0.141 lb a.i./A). These trials demonstratedthat formulated spirotetramathas the potential to affect honey bee broods and larval abundance for the range of rates examined when the adults of the hive are forced to forage exclusivelyon flowering crops, specificallyafter applicationto the crop at bloom or up to 

### 5 days prior to bloom. Where effects to the honey bee brood were observed, recovery was noted within 2-3 weeks. However, due to the design of these tests, not statistics could be performed. 

### In summary, it appears that although spirotetramatis not classified as highly acutely toxic to honey bees based on laboratory acute contact and oral toxicity tests, results ofbrood feeding studies and tunnel tests suggest the potential for effects to broods following spirotetramat applications. While it has been offered by the registrant that the tunnel tests represent exaggerated exposure conditionsby containing foraging bees to treated fields, it should also be pointed out that rates lower than the maximum proposed label rates induced toxic effects affecting the overallbee broods in these studies. 

### In addition, one of the field trials conducted on oilseed spring rape that supposedly represents more realistic exposure conditions, was conducted using single application rates approximatelyone half the maximum proposed single application rate of 0.16 lb a.i./A, but an overall application rate that was close to the maximum seasonal application rate of 0.40 lb a.i./A. However, for the field trial conducted in Spain, not only were the highest employed single application rates approximately equal to half the maximum single proposed application rate, but the overall employedtotal application rates were approximately half the maximum proposed seasonal applicationrate. Overall, the magnitude and nature of the effects in the environment are difficult to accurately predict based on the varied responses of the organisms and the uncertainties associated with the available field studies. However, based on the facts that spirotetramatis proposed for use as an insecticide, it has demonstrated toxic effects to bee broods under less than maximum application rates, data on two other chemicals representing the ketoenole class of compounds (spiromesifenand spirodiclofen) have also demonstrated the potential for chronic effects on bee broods and development while displaying low acute toxicity, it appears that the mode of action of these compounds (i.e., inhibition of lipid biosynthesis) may adversely affect bee broods and development and risk to honey bees cannot be precluded. 

### Miscellaneous Non-targetArthro~ods At first principles, it would appear reasonable that an insecticide would pose some risk to non-target terrestrial invertebrates, including non-target insects. The highest applicationrate of spirotetramat

### in a season is 0.40 lb a.i./A. Comparingthis application rate to the available insect toxicity data presented below suggests that acute effects on some insects (e.g. parasitoid wasps and predatory mites) are possible. In addition, even those studies that demonstratedno toxic effects did not test up to the highest proposed seasonal rate for spirotetramat. Therefore,the conclusion of this screening level risk assessment is that effects on non-target insects cannot be precluded.
Page 77 of 

### 120Formulated spirotetramat (Spirotetramat 150 OD) had a wide range in magnitude of acute effects on various non-target arthropods, fiom an LDSo greater than the highest rate tested (0.26 lb a.i./A) for a 48- - - hour acute contact studywith parasitoid wasp adults (Aphidius rhopalosiphi) exposed to dried residues on treated barleyplants, to an LDSo= 0.0003 lb a.UA for a 7-day acute contact toxicity test with predatory mite protonymphs (Typhlodromuspyri)exposedto dried residues on treated glass plates. Other acute contact studies included a 48-hour acute study with parasitoid wasp adults (Aphidius rhopalosiphi) exposed to dried residues on treated glass plates (LDSo=O. 10 lb a:i./A), a 7-day acute study with predatory mite protonymphs (Typhlodromuspyri)exposed to dried residues on treated bean leaves (LD50=0.0014 lb a.i./A; J, reproduction NOAEC 

### < 0.0001 lb a.i./A), a study with green lacewing larvae (Chvysoperia carnea) exposed to dried residues on treated bean leaves until pupation (LDS0 

### >0.26 lb a.i./A and no effects on reproduction), and a study with ladybird beetle larvae (Coccinella septempunctata)exposed to dried residues on treated bean leaves and fed treated aphids until pupation (LDSO 

### > 0.26 lb a.i./A and no effects on reproduction). 

### In addition, a 7-day acute contact studywith predatory mite protonymphs (Typhlodromuspyri) exposed to aged dried residues on apple leaves treated 4 times at 0.064 lb a.i./A demonstrated that residues aged 7 weeks or less could cause significant mortality (>51 %), indicating a lingering effect post application. The only field study that was conducted was in France and was aimed at evaluatingthe effects of spirotetramat on acarine mite fauna, including predatorymites, rust mites, and fimgivorous mites. Based on the results, it was concluded that BY108330 150 OD, applied twice at a nominal rate of 0.086 lb a.i./A or lower under a 15-day interval, or four times at a nominal rate of 0.004 lb a.i./A with a 6 to 8-day spray interval, has no effects on the acarine mite fauna. Earthworms and Other Soil-dwell in^ Invertebrates Based on the available information, spirotetramat and its degradates appear to be of relatively low toxicity to earthworms. 

### In 14-daystudies with spirotetramat and 

### spirotetramat-ketohydroxy,no treatment related effects were observed up to the highest tested concentration (EC5&CS0and NOAEC values were >I000 mglkg-dry weight soil). 

### In a 14-day study with 

### 4-methoxy-cyclohexanone, a NOAEC was established at 125mgkg-dry weight soil based on body weight effects. Lastly, in an 8-week study with spirotetramatenol, a 

### NOAEC of 32 mgkg-dry weight soil was establishedbased on a decrease 

### in the mean number of juveniles. No other effects were seen any of the studies. Only one studywas conducted with another soil-dwelling organism, other 

### than earthworms. This studywas a 34-dayreproduction studywith gamasid mite protonymphs (Hypoaspis aculeifer) and spirotetramat-enol. The NOAEC for mortality and decreased reproduction in this study were 3 

### 16 and >I000 mgkg-dry weight soil, respectively, while the LC50/EC50 for both was >I000 mglkg-dry weight soil. Although EFED has no current way to quantitatively estimate exposure and risk to earthworms and soildwelling organisms, if one assumes that all of the applied spirotetramat within a year is applied directly to soil, and very conservative and unrealistic estimate of exposure can be derived. Based on a maximum seasonal application rate of 0.40 lb a.i./season, and a possibility in some instances ofup to 3 growing seasons per year, the annual applicationrate can be estimated to be 1.20 lb a.i./year, or -0.0134 mg a.i./cm2. Assuming that spirotetramatis applied with a single application at this annual rate directly to soil with a bulk density of 1.3 g/cm3,and is integrated at a 1 cm depth, the maximum concentration of spirotetramatpossible in soil is -10 mg a.i./kg soil (0.0134mg a.i./cm2 1(1.3g/cm3 *lcm 

## * O.OOlkg/g) = -10 mg a.i.kg soil) 

## .Although this estimated concentration represents an unrealistically

### high exposure for the parent, let alone for the degradates, it still indicatesthat soil exposure concentrations are still more than
Page 78 of 120

### 3 times lower than the most sensitiveNOAEC currently available for soil-dwelling organisms and that risk to these organisms appears to be low. 

### d. Non-Target Plants Inhabiting Dry (Upland) and Semi-Aquatic (Wetland) Areas A comparison of the most sensitive measures of effect from the available vegetative vigor and seedling emergence studiesto EECs estimated based on the most conservative exposure scenario possible for spirotetramatusing TerrPlant (v1.2.2), demonstratesthat all RQs for upland and wetland monocots and dicots adjacent to the application site, are below the listed and non-listed plant species LOC of 1.0; the highest RQ was 0.55, roughly half of the Agency's LOCs. Therefore, the conclusion of this risk assessment is that the best available information currently available for the tested plants species indicates that risks of direct effects to all listed and non-listed upland and wetland plants are below the Agency's screening levels of concern. The one major uncertainty with respect to estimation and characterizationof risk to plants for spirotetramat revolves around its systemic nature and the potential uptake via root systems as an additionalroute of exposure. Due to the nature of exposure in the vegetative vigor study (foliar spray), endpoints derived from that study are inappropriate for estimating risk from runoff exposure; only the seedling emergence results are used to evaluate potential risk from runoff. However, if effects were seen on vegetative vigor at the same exposurethreshold via root uptake as via foliar spray, one could reasonably approximate risks to plants resulting from exposure via root uptake for characterization purposes only using the current NOAEC and EC25values from the available vegetative vigor study. This approach demonstratesthat while all RQs for dicots would stillbe below the LOCs, RQs for monocots inhabiting semi-aquatic areas (wetlands) would exceed both the non-listed and listed plant LOCs by less than an order of magnitude. However, the potential for cumulative effects to plants resulting from combined routes of exposure including root uptake are unclear because current guideline studies do not address potential effects from this route of exposure. Therefore, the potential implications for upland and wetland plant risk estimates remain uncertain. Another uncertainty results from the measures of effect selection for estimating risk to dicots from exposure to drift. Only one dicot specieswas affected in the available vegetative vigour studies; canola with an EC25=0. 17 lb a.i./A and NOAEC = 0.06 lb a.i./A. Although these results generated definitive toxicity estimates, the more conservativeEC25(>0.16 lb a.i./A) and the associatedNOAEC >0.16 lb a.i./A were selected for use to generate risk estimates for dicots exposed to 

### drift. Subsequently, risk to non-listed dicots may have been overestimated while risk to listed dicots was underestimated. Although some may questionthe selection of a non-definitive endpoint over one that was based on quantifiable effects, the choice in measurement endpoints did not affect the overall risk conclusions. 4. 

### Endocrine Effects Under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA), EPA is required to develop a screeningprogram to determinewhether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendationsof its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendationthat the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA, to the extent that effects in wildlife may help Page 79 of 

### 120determinewhether a substance may have an effect in humans, and the FFDCA authorityto require the wildlife evaluations. As the science develops and the resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor ScreeningProgram (EDSP). When the appropriate screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, spirotetramatmay be subjectedto additional screening and or testing to better characterize effectsrelated to endocrine disruption. Results of the avian reproduction studies demonstrate that dietary exposure to spirotetramat produces adverse effect on reproductive parameters. Observed effects in the submitted avian reproduction studies include, but are not limited to, treatment-related decreasesin # viable embryos of eggs set, mean hatchling body weight, mean 14-day survivor body weight, # of hatchlings of live 3-week embryos, # of 14-day survivorsof hatchlings, # of hatchlings of eggs set, # 14-day old survivors per hen, # of eggs laid per hen, # of eggs set, # of eggs set of eggs laid, # of 14-dayold viable embryos, # of 21-day old live embryos, # of eggs hatched, and # of eggs hatched of eggs laid. Results of the submitted 2-generation chronic reproduction study in mammals also show exposure to spirotetramat produces adverse effects on reproductiveparameters. Observed effects in the submitted mammalian reproduction studyinclude, but are not limted to, decreased body weight and body weight gain during lactation in both F1and F2generations, and abnormal sperm cells and decreased reproductive performance in the F1 males. Results of studies evaluating chronic/reproductiveeffects to aquatic organisms also show exposureto spirotetramat produces adverse effects on reproductiveparameters. Adverse effects include, but are not limited to, decreased fathead minnow 

### Ery survival, decreasedwater flea growth and reproduction, and decreased midge emergence and development. Results of these reproduction studies suggestthat spirotetramatcould be a candidate for additional screening and/or testing to better characterize effects related to endocrine disruption. V. 

### Federally Listed Threatened and Endangered Species Concerns A. Action Area For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by the Federal action and not merely the immediate area involved in the action. At the initial screeninglevel, the risk assessment considers broadly describedtaxonomic groups 

### and so conservatively assumes that listed species within those broad groups are collocated with the pesticide treatment area. This means that terrestrial plants and wildlife 

### are assumed to be located on or adjacent to the treated site and aquatic organisms are assumedto be located in a surfacewater body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area which has the relatively highest potential exposureto the pesticide, and that exposures are likelyto decrease with distance from the treatment area. The "Use Characterization" section of this risk assessment presents the pesticide use sites that are used to establish initial collocation of species with treatment areas. If the assumptions associated with the screening level action area result in RQs that are below the listed speciesLOCs, a "no effect" determinationconclusion is made with respect to listed species in that taxa, and no furtherrefinement of the action area is necessary. Furthermore,RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effectsupon listed speciesthat depend upon the taxonomic group covered by the RQ as a resource. However, in situations where the screening Page 80 

### of 

### 120

### assumptions lead to RQs in excess of the listed speciesLOCs for a given taxonomic group, a potential for 

### a "may affect" conclusion exists and maybe associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species,the locations of these species, and the locations of use sites could be considered to determinethe extent to which screening assumptions regarding an adtion area apply to a particular listed organism. These subsequent refinement steps could consider how this information would impact the action area for a particular listed organism and may potentially include areas of exposure that are dawnwind and downstream of the pesticide use site. 

### B. Taxonomic Groups Potentially at Risk 1. 

### Discussion of Risk Quotients 

### The screeninglevel risk assessment process for listed species employs the generic-taxonomic group-based process to make inferences on direct effect concerns for listed species. The first iteration of reporting the results is a listing of taxonomic groups for which RQ calculationsreveal values that meet or exceed the listed species LOCs. For those taxa or measurement endpoints for which RQs are not calculated (i.e., terrestrialinvertebrates) EFED uses any relevant data to make a qualitative assessment of potential exposurepathways and risks. An 

### evaluation ofrisk conclusionsfor each taxonomic group is presented below in Table V.1. 

### Should estimated exposure levels occur in proximity to listed resources, the available screeninglevel information suggests a potential concern for direct effects to listed terrestrial non-target invertebrate, avian, reptilian, and amphibian species associated with areas where spirotetramatis used.

Page 81 of 

### 1202. 

### Probit Dose ResponseRelationship Terrestrialinvertebrates, birds

Birds, terrestrial amphibians, and

The Agencyuses the probit dose response relationship as a tool for providing additional information on the listed animal species acute levels of concern. Acute listed species LOCs of 0.1 and 0.05 are used for terrestrial and aquatic animals, respectively. As part of the risk characterization, an interpretation of acute LOCs for listed species is discussed. This interpretationis presented in terms of the chance of an individual event (i.e., mortality or immobilization) should exposure at the estimated environmental concentration actually occur for a species with sensitivity to spirotetramaton par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation,the Agency uses the slope of the dose responserelationship available from the toxicity study used to establishthe acute toxicity measures of effect for each taxonomic group. However, in the specific case of spirotetramat,the most sensitive acute toxicity measure of effect used to derive RQs for estuarinelmarineinvertebrateswas from a study with eastern oysters, and was not based on mortality or immobilization. Therefore,the 

### mortalitylimmobilization data availablefor mysids was used to perform these analyses for estuarinelmarineinvertebrates.

Mammals Aquatic plants (vascular and nonvascular)

Fish, aquatic amphibians2 Aquatic Invertebrates

The individual effectsprobability associated with the LOCs is based on the mean estimate of the slope and an assumption of a probit dose response relationship. In addition to a single effects probability estimate 'Birds areused as surrogate species for terrestrial-phaseamphibians andreptiles; therefore, potential direct andindirect effectsto endangered avian,reptiliaq and amphibian species are considered equivalent.

Fish areused as a surrogatefor aquatic phase amphibians; therefore,potential direct and indirect effects to endangered fish and amphibian species are considered equivalent. No
No
No No No LOCs were exceeded No LOCs were exceeded No LOCs were exceeded No LOCs were exceeded Yes
Yes
Yes Yes Terrestrial invertebrates
Terrestrialinvertebrates Terrestrial invertebrates,birds, terrestrial amphibians, and reptiles Birds, terrestrial amphibians, and reptilesbased on the mean, upper and lower estimates of the effects probability are also provided to account for variance in the slope. The upper and lower bounds of the effects probability arebased on available information on the 95% confidence interval of the slope. A statementregarding the confidence in the estimated event probabilities is also included. Studies with good probit fit characteristics (i.e., statistically appropriate for the data set) are associated with a high degree of confidence. Conversely, a low degree of confidenceis associated with data from studies that do not statistically support a probit dose response relationship. In addition, confidence in the data set may be reduced by high variance in the slope (i.e., large 95% confidenceintervals), despite good probit fit characteristics. Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.l (Individual Effect Chance Model Version 1.l)developedby the U.S. EPA, OPP, EnvironmentalFate and Effects Division (June 22,2004) (TableV.2). The model allows for such calculationsby entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slopeparameter for the spreadsheet. 

### In addition,the LOC (0.1 for terrestrial animals and 0.05 for aquatic animals) is entered as the desired threshold. The chance of an individual event correspondingto the listed species acute LOCs is calculated based on the formula logLCk = logLCso+(z/b),where z is the standard normal deviate and b equals the slope. If an LDsO or LCSO has been established for a particular taxonomic group, but information is unavailable to estimate a slope from a study, a default slope assumption of 4.5 is used as per original Agency assumptions of typical slope cited in Urban and Cook (1986). In instances where an LCs0 or LDSO has not been established for a particular taxonomic group and no mortalitywas observed in the available studies, an individual effects probability is not estimated. Freshwater Fish (Nieden. 2005b) Based on an assumption of a probit dose response relationship (Pearson Chi-Square; 

### p = 0.0576) with a mean estimated slope of 5.6, the correspondingestimated chance of individual mortality associated with the listed speciesLOC of 0.05 the acute toxic endpoint for freshwater fish is 

### -1 in 6.25 

### x 1012. It is recognized that extrapolation of very low probability events is associatedwith uncertainty in the resulting estimates. To explorepossible bounds to such estimates,the upper and lower values for the mean slope estimate (0.99 to 10.22) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are 

### -1 in 10.1 and 

### -1 in 8.25 

### x respectively. EstuarineIMarine Fish Banman & Lam. 2005) Based on an assumption of a probit dose response relationship (Pearson Chi-Square; 

### p = 0.733) with a mean estimated slope of 5.7, the correspondingestimated chance of individual mortality associated with the listed species LOC of 0.05 the acute toxic endpoint for estuarinelmarine fish 

### is -1 in 1.66 

### x 1013. It is recognized that extrapolation of very low probability events is associated with uncertainty in the resulting estimates. To explore possible bounds to such estimates, the upper and lower values for the mean slope estimate (3.50 to 7.90) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are 

### -1 in 3.79 

### x 

## lo5and -1 in 2.26 

### x loz4, respectively. Freshwater Invertebrates CDorgerloh. 2006b) Based on 

### an assumption of a probit dose response relationship (Pearson Chi-Square; 

### p = 0.97) with a mean estimated slope of 6.73, the corresponding estimated chance of individual mortality associated with the listed species LOC of 0.05 the acute toxic endpoint for freshwater invertebrates is -1 in 9.88 

### x 10". It is recognized that extrapolation of very low probability events is associatedwith uncertainty in the

### resulting estimates. To explore possible bounds to such estimates,the upper and lower values for the mean slope estimate (4.92 to 

### 8.54) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are -1 in 

### 1.30 

### x 10'' and 

### -1 in 

### 1.80 

### x lo2', respectively. EstuarineIMarine Invertebrates (Based on Mvsid data: Cafarelle. 

### 2005aj Based on an assumption of a probit dose response relationship with a mean estimated slope of 2.93, the correspondingestimated chance of individual mortality associated with the listed species LOC of 0.05 the acute toxic endpoint for estuarinelmarine invertebrates 

### is -1 

### in 

### 1.45 

### x 

## lo4. It is recognized that extrapolation of very low probability events is associatedwith uncertainty in the resulting estimates. To explorepossible bounds to such estimates,the upper and lower values for the mean slope estimate (0.79 to 

### 5.06) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are -1 

### in 

### 6.58 and -1 

### in 

### 4.34 

### x 101°,respectively. Althoughthe Agency has assumed a probit dose response relationship in establishingthe listed species LOCs, the available data for the toxicity study generatingRQs for this taxonomic group do not statistically support a probit dose response relationship (Pearson Chi-Square;

### p = 

### 0.0041) and so the confidence in estimated event probabilities based on this dose response relationship and the listed species LOC is low. Birds (Barfknecht, 

### 2003) The available acutetoxicity studies (both dietary and dose-based)on avian species were unable to establish toxicityvalues (LCSo or LD50). It was demonstratedthat the LCSO and LD50values were greater than the highest levels tested. However, in the acute oral study, there were two treatment-related mortalities at the highest tested concentration. Therefore, a 

### default slope value of 4.5 with upper and lower bounds of 2 and 9, respectively, were assumed. Based on an assumption of a probit dose response relationship with a mean estimated slope of 4.5, the corresponding estimated chance of individual mortality associated with the listed species LOC of 0.1 the acutetoxic endpoint for birds 

### is -1 

### in 

### 2.94 

### x lo5.It is recognized that extrapolation of very low probability events is associatedwith considerable uncertainty in the resulting estimates. To explorepossible bounds to such estimates, the upper and lower values for the mean slope estimate (2 to 

### 9) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are -1 in 

### 44 and 

### -1 in 

### 8.86 x 

### lo1', respectively. The uncertainty in estimated event probabilities for this taxonomic group is high based on the use of default slope estimates and large confidenceintervals. Given the large uncertainty associated with the probability estimates, it is not possible to predict the chance of an individual mortality event for listed avian species. Mammals (Eigenberg. 

### 2004) The available acutetoxicity studies on mammalian specieswere unable to establish toxicity values (i.e., LD50). It was demonstrated that the LDSO is greater than 2000 mg a.i./kg-bw with no treatment-related mortality occurring up to this test level. Therefore, this risk assessment is unable to fit a probit dose responserelationship to the available data to estimate an individual effects probability for mammalian species based on LDSO values.

Freshwater fish Estuarine/marine fish 5.61 (0.99, 10.22) 5.70 (3.50, 7.70) -1 in 6.25 x 1012 (-1 in 10.1 and-1 in 8.25 x 

### -1 in 

### 1.66x l0l3 (-1 in 

### 3.79 x lo5

### and -1 in 2.26 x

### C. Indirect Effects Analysis The Agency acknowledgesthat pesticides have the potential to exert indirect effects upon the listed organisms by, for example, perturbing forage or prey availability, altering the extent of nesting habitat, and creating gaps in the food chain. 

### In conducting a screen for indirect effects, direct effect LOCs for each taxonomic group are used to make inferences concerningthe potential for indirect effects upon listed species that rely upon non-endangered organismsin these taxonomic groups as resources critical to their life cycle. Species specific concerns for spirotetramat indirect effects to listed organisms will require a determination of the coincidence of spirotetramatuse with locations of listed species and the biologically based resources upon which they depend. -1 in 9.88 x l0l7 (-1 in 1.30 x 10'' and -1 in 1.80 x lo2') -1 in 1.45 x lo4 (-1 in 6.58 and -1 in 4.34 

### x lo1') -1 in 2.94 x lo5 (-1 in44 and-1 in 8.86 

### x 10") Not calculated;no mortality observed Freshwater invertebrates Estuarinelmarineinvertebrates Birds Mammals

The Agency uses the dose response relationship from the toxicity study used for calculating the RQ to estimate the probability of acute effects associated with an exposure equivalent to the EEC (see "Probit Dose Response Relationship" section above). In instances where information on the dose response is available, it serves as a guide to establish the need for and extent of additional analysis that may be performed using Services-provided "species profiles" as well as evaluations of the geographical and temporal nature of the exposureto ascertain if a "not likely to adverselyaffect" determinationcan be made. The degree to which additional analyses are performed is commensurate with the predicted probability of adverse effects from the comparison of the dose response information with the EECs. The greater the probability that exposures will produce effects on a taxa, the greaterthe concern for potential indirect effects for listed species dependant upon that taxa, and therefore, the more intensive the analysis on the potential listed species of concern, their locations relative to the use site, and information regarding the use scenario (e-g.,timing, frequency, and geographical extent of pesticide application). 6.73 (4.92, 8.54) 2.93 (0.79,5.06) 4.5 (2,9) None available

Relative to spirotetramat proposed usage, EFED's screening level analysis shows that there is a concern for indirect effects to listed species that may depend upon other taxonomic group for their survival (e.g., invertebrates as a food source for listed fish, etc.). This assessment identifiedthe potential for direct effects (risks)to beneficial insects/terrestrialinvertebrates and birds as result of the proposed uses of spirotetramat. Therefore, the nature of the toxicological endpoint, Services-provided "species profiles", and further evaluation of the geographical and temporal nature of the exposure will need to be considered to determine if a rationale for a "not likely to adversely effect" determination is possible. Indirect effects analyses for organisms that depend on insects and birds as a critical component of their resource needs are summarized in 

### Table 

### V.1. D. Critical Habitat 

### In the evaluation of pesticide effects on designated critical habitat, considerationis given to the physical and biological features (constituent elements) of a critical habitat identifiedby the U.S Fish and Wildlife and National MarineFisheries Services as essentialto the conservationof a listed species and which may require specialmanagement considerationsor protection. The evaluation of impacts for a screening level

### pesticide risk assessment focuses on the biological featuresthat are constituent elements and is accomplished using the screening level taxonomic analysis (risk quotients, RQs) and listed species levels of concern (LOCs) that are used to evaluate direct and indirect effects to listed organisms. The screening level risk assessmenthas identified potential concerns for indirect effects on listed species for those organisms dependant upon beneficial insectslterrestrial invertebrates and birds. 

### In light of the potential for indirect effects, the next step for EPA and the Service(s)is to identify which listed species and critical habitat are potentially implicated. Analytically, the identification of such species and critical habitat can occur in either of two ways. First, the agencies could determinewhether the action area overlaps critical habitat or the occupied range of any listed species. If 

### so, EPA would examine whether the pesticide's potential impacts on non-endangered species would affectthe listed species indirectly, or directlyaffect a constituent element of the critical habitat. Alternatively, the agencies could determine which listed species depend on biological resources, or have constituent elements that fall into the taxa that may be directlyor indirectly impactedby the pesticide. Then EPA would determine whether use of the pesticide overlaps the critical habitat or the occupied range of those listed species. At present, the information reviewed by EPA does not permit use of either analytical approach to make a definitive identification of species that are potentially impacted indirectly or critical habitats that is potentially impacted directlyby the use of the pesticide. EPA and the Service(s)are working together to conduct the necessary analysis. This screeninglevel risk assessment for critical habitat provides a listing ofpotential biological features that, if they are constituent elements of one or more critical habitats, would be ofpotential concern. These correspondto the taxa identified above as being ofpotential concern for indirect effects and include the following: beneficial insectslterrestrial invertebrates and birds. This list should serve as an initial step in problem formulation for 

### fUrther assessment of critical habitat impacts outlined above, should additional work be necessary. 

### E. Co-occurrence Analysis 

### The goal of the analysis for co-location is to determinewhether sites ofpesticide use are geographically associated with known locations of listed species. At the screeninglevel, this analysis is accomplished using the LOCATES database. The database uses location information for listed species at the county level and compares it to agricultural census data for crop production at the same county level of resolution. The product is a listing of federally listed speciesthat are located within counties known to produce the crop upon which the pesticidewill be used. Because the Level 

### I screening assessment considers both direct and indirect effects 

### across generic taxonomic groupings, it is not possible to exclude any taxonomic group from a 

### LOCATES database run 

### for a screening level risk assessment. Given the extent of spirotetramat usage across the U.S. 

### for the proposed uses and the expected large number of listed species that are likely to occur in 

### counties where spirotetramatis used, a list of endangeredlthreatened species and crop acreage at the county level for the taxonomic groups and crops of concern is not included in this phase of the risk assessment process. Given that the potential extent of spirotetrarnat usage for the proposed uses includes every state, and that all taxonomic groups are included in the initial LOCATES run for a screening level risk assessment, Appendix H 

### provides the entire list of endangeredlthreatenedspecies at the state level. The registrant must provide information on the proximity of Federally listed birds, fish, mammals, amphibians, crustaceans, reptiles, arachnids, insects, plants, snails, and clamsto the spirotetramat use sites. This requirement may be satisfied 

### in one of three ways: 1)having membership in the FIFRA Endangered Species Task Force

### (Pesticide Registration 

### [PR] Notice 2000-2); 2) citing FIFRA Endangered Species Task Force data; or 

### 3) independently producing these data, provided the information is of sufficient qualityto meet FFRA requirements. The information will be used by the OPP Endangered Species Protection Program to develop recommendationsto avoid adverse effects to listed species. VI. Literature Cited Environmental Fate Studies Discussed in Assessment

MRID 46904408 Bayer CropScienceAG, Report No.: MEF-041169, Edition Number: M-256849-02-2 Date: 07.07.2005, Amended: 05.05.2006

Bayer CropScienceAG, Report No.: MEF-061041,

KIIA 7.1.1 1031 MRTD 46904428

KIIA 7.1.2 1011 MRID 46904410

KIIA 7.1.3 1011 MRID 46904503

KIIA 7.2.1 101 Babczinski, P.

Menke, U.

Heinemann, 0.

Babczinski, P. 2006c

2006

2005

2006a EditionNumber: M-270597-01-2 Date: 03.04.2006 GLP, unpublished [Azaspirodecenyl-3-l4CI- and [azaspirodecenyl-5-l4CIlabelled BYI08330-cis-enol: Comparative aerobic soil metabolisddegradation in four soils Bayer CropScienceAG, Report No.: MEF-051157, Edition Number: M-269304-01-2 Date: 17.01.2006 GLP, unpublished also filed. KIIA 7.2.3 I01 BYI08330: Anaerobic soil metabolism Bayer CropscienceAG, Report No.: MEF-051515, Edition Number: M-270739-01-2 Date: 03.05.2006 GLP, unpublished also filed: KIIA 7.2.4 101 [Azaspirodecenyl-3-14Cl- and [azaspirodecenyl-5- 14ClBYI08330: Phototransformation on soil Bayer CropScienceAG, ReportNo.: MEF-04/48 1, Edition Number: M-252907-01-2 Date: 25.04.2005 GLP, unpublished Aerobic degradatidmetabolism of BY18330 in four Yes

Yes

Yes

Yes BCS

BCS

BCS

BCSReport No.: MEF-041169, EditionNumber: M-256849-02-2 Date: 07.07.2005, Amended: 05.05.2006

eportNo.: MEF-051249,

KIIA 7.2.3 I01

KIIA 7.2.3 1021 No MRID

KIIA 7.2.3 I031 MRID 46904420

KIIA 7.2.4 101

KlJA 7.3.1 1011 MRID 46904414 Babczinski, P.

Roepke, B.

Dehner, D.; Heinemann, 0.

Menke, U.

Netzband, D. J. 2006c

2007

2006

2006a

2006a Edition Number: M-277096-0 1-2 Date: 30.08.2006 Non GLP, unpublished [Azaspirodecenyl-3-l4CI-and [azaspirodecenyl-5-l4Cllabelled BYI08330cis-enol:Comparative aerobic soil metabolisddegradation in four soils Bayer CropScienceAG, Report No.: MEF-051157, Edition Number: M-269304-01-2 Date: 17.01.2006 GLP, unpublished alsofiled: KUA7.1.1 103 Kinetic evaluation of laboratory soil degradation studies of BYI08330-Enol, BYI08330-ketohydroxy, BYI08330-MAamide Bayer CropScienceAG, Report No.: MEF-061199, Edition Number: M-277178-01-2 Date: 31.05.2007 Non GLP, unpublished [Carbonyl-14C] 4-methoxycyclohexanone: Aerobic soil degradationin three soils Bayer CropScienceAG, Report No.: MEF-051485, EditionNumber: M-269022-02-2 Date: 28.02.2006, Amended: 18.07.2006 GLF', unpublished BYI08330: Anaerobic soil metabolism ' Bayer CropScienceAG, Report No.: MEF-051515, Edition Number: M-270739-01-2 Date: 03.05.2006 GLP, unpublished also filed. KUA 7.1.2 101 Jnhouse laboratory validation of an analyticalmethod far the determinationof BY108330 and its metabolites BYI08330-enol, BYI08330-ketohydroxy and BYI08330- MA-amide in soil and sedimentby LC/MS/MS Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, ReportNo.: RAFNX012, Yes

Yes

Yes

Yes

Yes BCS

BCS

BCS

BCS

BCSDate: 29.08.2006

Bayer CropScienceAG, Report No.: MEFNY004, EditionNumber: M-277191-01-1

Bayer CropScience, Stilwell, KS,USA Bayer CropScienceAG, ReportNo.: MEFWXO55, Edition Number: M-277184-01-1

Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG,

KK4 7.3.1I051 MRJD 46904423

KIIA 7.3.1 I061 MRID 46904417

KU.4 7.3.1 /07/ Lenz,Mark

Netzband, D. J.

Brumhard, B. 2006d

2006b

2006 Report No.: MEFNY002, EditionNumber: M-277186-01-1 Date: 05.09.2006 GLP, unpublished Terrestrial field dissipationof BYI08330 in Washington soil, 2004 Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, Report No.: MEFNY003, EditionNumber: M-277189-01-1 Date: 05.09.2006 GLP, unpublished StabilityofAE 03 17309 and AE B197555 in soil during himstorage,USA, 2005 (reported through a maximum of 320 days storage) Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, Report No.: RAFNXO18, Edition Number: M-277371-01-1 Date: 29.08.2006 GLP, unpublished Independentlaboratory validationofmethod FN-002-SO5- 02 for the determinationof BYI08330 and its metabolites BY108330-en04 BYI08330-keto-hydroxyand BYI08330- MA-amide in soil and sediment by LSNSIMS Bayer CropScience, Stilwell,KS, USA Bayer CropScienceAG, Report No.: MR-061037, Yes

Yes

Yes BCS

BCS

BCSEdition Number: - Date: 31.05.2007
Bayer CropScienceAG,

KUA 7.4.2 I011 MRID 46904429

KIIA 7.4.2 I021 MRID 46904430

KIIA 7.4.2 1031 MRID 46904425

KllA 7.4.2 1041 MRID 46904432

KUA 7.4.2I051 MRID 46904433 Hein, W.

Menke, U.

Hein, W.

Simmonds,M.; Early, E.

Neumann, B.; Klempner,A. 2005a

2006b

2005b

2005

2006 Report No.: MEF-041373, EditionNumber. M-266755-01-2 Date: 21.10.2005 GLP, unpublished Adsorpton/desorption of BYI08330-cis-en01 in five different soils Rheinland-PfalzAgroScience GmbH, Neustadt, Germany Bayer CropScienceAG, Report No.: IM2000, EditionNumber: M-267858-01-2 Date: 05.09.2005 GLP, unpublished [Azaspirodecenyl-3-l4C]BYIO8330-enol: Time-dependent sorptionin soils Bayer CropScienceAG, Report No.: MEF-051222, Edition Number: M-268122-01-2 Date: 25.01.2006 GLP, unpublished 14C-BYI08330-ketohydroxy: Adsorption/desorption in five soils Rheinland-PfalzAgroScience GmbH, Neustadt, Germany Bayer CropScienceAG, Report No.: IM200 1, Edition Number: M-267955-02-2 Date: 09.09.2005, Amended: 30.08.2006 GLP, unpublished [14C]-BYI08330-MA-amide: Adsorption to and description fromfive soils BattelleUKLtd.; Ongar; United Kingdom Bayer CropScienceAG, ReportNo.: CXl041070, EditionNumber: M-263686-01-2 Date: 07.09.2005 GLP, unpublished Estimationofthe adsorption coefficient(Koc) of BYI 08330-en01 dimer 1 (ROI 6,14C-labelled) and BY1 08330-en01 dimer 2 (ROI7,14C-labelled) on soil using high performance liquid chromatography (HPLC) Bayer CropScienceAG, Report No.: MEF-061123, Yes

Yes

Yes

Yes

Yes BCS

BCS

BCS

BCS

BCSKIIA 7.4.4 I011 MRID 4690443 1

KIIA 7.4.4 I02

KIIA 7.4.9 I011 No MRID

KIIA 7.4.9 1021 No MRID

KIIA 7.5 I011MRID 46904405

KIIA 7.5 I021MRID 46904426

KIIA7.61011MRID 46904406 Babczinski, P.

Hamme1K.

Franke, J.

Bogdoll, B.

Heinemam, 0.

Heinemann, 0.

Stupp,H.-P. 2006d

2007

2004

2005

2004a

2004b

2005a Date: 19.05.2006, Amended: 01.06:2007 GLP, unpublished BYI08330-enol: Soil column leaching Bayer CropScienceAG, Report No.: M-270280-02-2, Edition Number: M-270280-02-2 Date: 24.03.2006, Amended: 22.05.2006 GLP, unpublished Analysis ofthe sorptionbehaviour of BYI08330-En01 using a column leaching experiment Bayer CropScienceAG, Report No.: MEF-071220 Edition number: -, Date: 04.06.2007, Non GLP, unpublished BYI 08330, Mix-Batch0~04510003 - Vapour pressure SiemensAxiva GmbH & Co. KG, FrankFurt am Main, Bayer CropScienceAG, Report No.: 20040156.02, EditionNumber: M-066171-01-1 Date: 26.04.2004 GLP, unpublished also fild KUA 2.3.1 101 Henry's law constant ofBY108330(AE 1302943) at pH 7 and pH 9 Bayer CropScienceGmbH, Fmnkfwt am Main, Germany Bayer CropScienceAG, Report No.: AF051085, Edition Number: M-262215-01-1 Date: 08.12.2005 Non GLP, unpublished also filed: KUA 2.3.2 101 [Azaspircdecenyl-3-l4CI- and [azaspirodecenyl-5- 14C]BYI08330:Hydrolytic degradation Bayer CropScienceAG, Report No.: MEF-041176, Edition Number: M-093124-01-2 Date: 08.09.2004 GLP, unpublished also filed: KUA 2.9.1 101 [Azaspirodecenyl-3-l4CI- and [azaspirodecenylJ14C]BYIO8330-enol: Hydrolytic degradation Bayer CropScienceAG, Report No.: MEF-0413 11, Edition Number: M-242999-01-2 Date: 03.12.2004 GLP, unpublished BYI08330: Phototransformation of BYI08330 in sterile water Bayer CropScienceAG, Yes

Yes

Yes

Yes

Yes

Yes

Yes

\ BCS

BCS

BCS

BCS

BCS

BCS

BCSDate: 15.11.2005

Report No.: MEF-051262, Edition Number: M-266753-01-2 Date: 15.11.2005

Bayer CropScienceAG, Report No.: MEF-041080, EditionNumber: M-092941-01-2 Date: 28.09.2004

photodegradation in water

IUIA 7.7 1011 No MRZD

IUIA 7.8.3 I011 MRID 469044 12

KUA 7.8.3 1021 No MRlD Weyers, A.

Menke, U.

Roepke, B. 2005

2006

2006 ' Bayer CropScienceAG, Report No.: MEF-041438, Edition Number: M-243787-01-2 Date: 10.01.2005 GLP, unpublished BY108330 

### - Biodegradation Bayer Industry Services,Leverkusen, Germany Bayer CropScienceAG, Report No.: 200510077101, EditionNumber: M-263287-01-1 Date: 16.11.2005 GLP, unpublished BYI08330: Aerobic aquatic metabolism Bayer CropscienceAG, Report No.: MEF-0415 11, Edition Number: M-269307-01-2 Date: 29.03.2006 GLP, unpublished Kinetic evaluation ofthe aerobic aquatic metabolism of BM08330, BYI08330-en01 and BYIO8330-ketohydroxy in water sediment systems Bayer CropScienceAG, Report No.: MEF-061279, EditionNumber: M-277415-01-1 Date: 30.08.2006 Non GLP, unpublished Yes

Yes

Yes BIS

BCS

BCSBayer CropScienceAG, Report No.: M-261943-01-1, EditionNumber: M-26194341-1 Date: 06.12.2005

Report No.: MEF-041400,

KlIA 7.10 I021No MRID

KIIA 7.13 101

KIL47.131021No MRTD

KIIA 7.13 1031 No MRID

KIIA 7.13 1041 No MRID Hellpointner,E.

Hellpointner, E.

Eyrich,U.; Bogdoll, B.

Bogdoll, B.; Eyrich, U.

Bogdoll, B.; Me, G.; 2004b

2007

2006

,

2006

2006 EditionNumber: M-09284041-1 Date: 14.09.2004 Non GLP, unpublished also filed: KIIA 2.10 101 Calculationofthe chemical lifetime of BY108330-en01 in the troposphere Bayer CropScienceAG, Report No.: MEF-041401, Edition Number: M-09284141-1 Date: 21.09.2004 Non GLP, unpublished Position Paper: Spirotetramat(BYIO8330) -Fate and Behaviour Bayer CropScienceDeutschland GmbH, Fmnkfwt am Main, Germany Bayer CropScienceAG, Report No.: MEF-071299, Edition Number: - Date: 06.07.2007 GLP, unpublished Water solubilityofBY108330-en01 (AE 1302944)at pH 5, pH 7 and pH 8 (Flask Method) Bayer CropScienceGmbH, Fmnkfwt am Main, Germany Bayer CropScienceAG, Report No.: PA061035, EditionNumber: M-27582941-2 Date: 11.08.2006 GLP, unpublished Partition coefficients 1-Octanollwater of BY108330-en01 (AE 1302944) at pH 5, pH 7 and pH 9 (Shake flask method) Bayer CropScienceDeutschland GmbH, Frankhrt am Main, Germany Bayer CropScienceAG, Report No.: PA061036, EditionNumber: M-27609 1-01-2 Date: 17.08.2006 GLP, unpublished BYI 08330-en01 (AE 1302944)

### - Determinationofthe dissociation constant (spectrophotometricscreening Yes

Yes

Yes

Yes

Yes BCS

BCS

BCS

BCS

BCS

### Ecolopical Effects StudiesDiscussed in this Assessment Or~anized Accordinp to Annex PointIReference Number ropscienceGmbH, Frankfurt am Main, Germany Bayer CropScienceAG, Report No.: AFO61031, EditionNumber: M-274084-0 1-2 Date: 05.07.2006

am Main, Germany Bayer CropScienceAG, Report No.: PA051099,

KIIA 7.13 1061 No MRID

KIIA 7.13 I071 No MRID

Annex point1 reference number or MRID Number Bogdoll, B.; Lemke, G.

Bogdoll, B.; Lemke, G.; Kaussmann,M.

Author(s) 2005b

2005

Year

Annex 11Data and Information Edition Number: M-268425-01-2 Date: 06.09.2005 GLP, unpublished BY1 08330-cis-ketohydroxypartition coefficient 1- Octanollwater(HPLC-method) Bayer CropScienceGmbH, Frankfurtam Main, Germany Bayer CropScienceAG, Report No.: PA05-098, EditionNumber: M-268428-01-2 Date: 06.09.2005 GLP, unpublished BYI 08330-cis-ketohydroxy (AE 1422479) Determination of the dissociation constant (spectrophotometric screening method) - Code: PBF-2005-0070-TOX-06867 Bayer CropScienceGmbH, Frankfurtam Main, Germany Bayer CropScienceAG, Report No.: AF051098, EditionNumber: M-263603-01-2 Date: 16.12.2005 Non GLP, unpublished

2003 11.4 8.1.1 Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not Barfknecht, R. Yes

Yes

Acute oral toxicity for bobwhite quail (Colinus virginianus) for the test item BY1 08330 (tech.) Bayer CropScienceAG, Report No.: M-115911-02-2, Edition Number: M-115911-02-2 Date: 29.10.2003, Amended: 13.01.2006 GLP unpublished BCS

BCS

Data Protection Claimed Y/N-RINR Owner

Yes BCSOwner

BCS

BCS

BCS

BCS

BCS

BCS Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes

Yes Annex point/ reference number or MRID Number IIA 8.1.2

IIA 8.1.3

IIA 8.1.4

IIA 8.1.4

IIA 8.1.4

IIA 8.1.4 Year

2004

2006

2006a

2006b

2007a

2007b Author(s)

Barfknecht, R.

Stoughton,T. L.

Sabbert, T. J.; Nuessle, C.

Sabbert,T. J.; Nuessle, C.

Stafford, J. M.

Stafford,J. M. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not BYI 08330 techn. a.s.: 5-daydietaryLC50 bobwhite quail (Colinusvirginianus) Bayer CropScienceAG, Report No.: BAR/LC017, Edition Number: M-084796-01-2 Date: 18.08.2004 GLP unpublished TechnicalBYI 08330: A subacute dietaryLC50 with mallards Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, ReportNo.: EBFNX012, EditionNumber:M-274385-01-1 Date: 03.05.2006 GLP unpublished Effect oftechnical BYI 08330 on northern bobwhite reproduction Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, Report No.: EBFN0220, EditionNumber: M-277757-01-1 Date: 21.09.2006 GLP unpublished Effect oftechnicalBY108330 on mallardreproduction Bayer Cropscience, Stilwell, KS, USA Bayer CropScienceAG, Report No.: EBFNX013, Edition Number: M-277794-01-2 Date: 22.09.2006 GLP unpublished Long-Tam Mallard Duck Dermal Exposure to BY1 08330 Bayer CropScienceAG, ReportNo.: EBFNP033 Edition Number: M-290165-01-1 Date: 05.07.2007 GLP unpublished Semi-Field Studyofthe Effects of Dermal and Dietary Exposure to BYI 08330 in MallardDucks (Anas platyrhynchos) Bayer CropScienceAG, Report No.: EBFNP034 EditionNumber: M-290000-0 1-1 Date: 26.06.2007 GLP unpublishedData Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes

Yes Annex point1 reference number or MRID Number IIA 8.1.4 I03

IIA8.2.1.1

IIA 8.2.1.2

IIA 8.2.1.2

IIA 8.2.1.3

IIA 8.2.1.3 Owner

BCS

BCS

BCS

BCS

BCS

BCS Year

2006

2004a

2004b

2005a

2005a

2006a Author@)

Temple, D.L; Martin, K.H.; Beavers, J.B.; Jaber, M.

Dorgerloh, M.

Dorgerloh, M.

Dorgerloh, M.

Nieden, D.

Neuhahn, A. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not BY108330 technical: A reproduction study with the mallard Wildlife InternationalLtd., Easton, MD, USA Bayer CropScienceAG, Report No.: EBFNP024, EditionNumber: M-278058-0 1-1 Date: 29.09.2006 GLP unpublished Acute toxicity of BY108330 (tech.) to fish (Oncorhynchus mykiss) Bayer CropScienceAG, Report No.: DOM 24025, Edition Number: M-182649-0 1-2 Date: 16.12.2004 GLP unpublished Acute toxicity ofBY108330 (tech.) to fish (Cyprinus carpio) Bayer CropScienceAG, Report No.: DOM24022, Edition Number: M-128667-01-2 Date: 25.1 1.2004 GLP unpublished Acute toxicity of BY108330 (tech.) to fish (Lepomis macrochirus) Bayer CropScienceAG, Report No.: DOM 24056, Edition Number: M-242689-01-2 Date: 12.01.2005 GLP unpublished Acute toxicity of BY108330-en01to fish (Oncorhynchusmykiss) BayaCropScienceAG, Report No.: EBFNM013, Edition Number: M-251850-01-2 Date: 18.05.2005 GLP unpublished 4-Methoxycyclohexanone - Acute fish toxicity Bayer Industry Services,Leverhen Bayer CropScienceAG, ReportNo.: 2006/0032/02, Edition Number: M-274305-01-1 Date: 10.07.2006 GLP unpublishedData Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes

Yes Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not Early-lifestagetoxicity of BYI 08330 tech to fish (Pimephalespromelas) Bayer CropScienceAG, ReportNo.: EBFN0305, EditionNumber: M-260676-01-2 Date: 16.11.2005 GLP unpublished Acute toxicity of BYI 08330 (tech.) to the waterflea Daphnia magna under static conditions Bayer CropScienceAG, Report No.: DOM 24004, EditionNumber: M-242683-01-2 Date: 14.01.2005 GLP unpublished Acute toxicity of BYI 08330-en01to the waterflea Daphnia magna in a static laboratory test system -limit test Bayer CropScienceAG, Report No.: EBFNM012,

. Edition Number: M-254487-01-2

Date: 14.07.2005 GLP unpublished 4-Methoxycyclohexanone - Acute daphniatoxicity Bayer Industry Services,Leverkusen, Germany Bayer CropScienceAG, Report No.: 2006/0032101, EditionNumber: M-274275-01-1 Date: 10.07.2006 GLP unpublished Influence ofBY108330 (tech.) on development and reproductive output ofthe waterfleaDaphnia magna in a static renewal laboratory test system Bayer CropScienceAG, Report No.: EBFN0245, EditionNumber: M-25 1843-01-2 Date: 13.05.2005 GLP unpublished Pseudokirchneriella subcapitata - Growthinhibition test with BY108330 (tech.) Bayer CropScienceAG, Report No.: DOM 23092, EditionNumber: M-128874-0 1-2 Date: 29.11.2004 GLP unpublished Owner

BCS

BCS

BCS

BCS

BCS

BCS Year

2005b

2005c

2005d

2006b

2005e

2004c Annex point/ reference number or MRID Number IIA 8.2.4

JL4 8.3.1.1

IIA 8.3.1.1

IIA 8.3.1.1

IIA 8.3.2.1

IIA 8.4 Author@)

Dorgerloh, M.

Dorgerloh, M.

Dorgeloh, M.

Neuhahn, A.

Dorgerloh, M.

Dorgerloh, M.Annex point1 reference number or MRID Number IIA 8.4

IIA 8.4

IIA 8.4

IIA 8.4

IIA 8.5.1

IIA 8.5.1 Year

2005

2006

2005f

2006

2005g

2005h Anthor(s)

Kern, M.E.; Lam, C.V.

Kern, M. E.; Lam, C. V.

Dorgerloh, M.

Weyers, A.

Dorgerloh, M.

Dorgerloh, M. Title Source (where different from company) Company, Report No GLP or GEP status (whererelevant) Published or not Toxicityof BY1 08330 to the heshwater diatom Naviculapelliculosa Bayer CropScience,Stilwell,KS, USA Bayer CropScienceAG, ReportNo.: EBFNX008, Edition Number: M-252794-0 1-1 Date: 15.06.2005 Non GLP unpublished Toxicityof BYI 08330 to the blue-green alga AnabaenaJlos-aquae Bayer Cropscience, Stilwell,KS, USA / Bayer CropScienceAG, Report No.: EBFNX007, EditionNumber: M-264055-0 1-1 Date: 12.01.2006 GLP unpublished Pseudokivchneriella subcapitata - Growth inhibition test with BY108330-en01 Bayer CropScienceAG, ReportNo.: EBFNMOIO, Edition Number: M-252531-01-2 Date: 06.06.2005 GLP unpublished 4-Methoxycyclohexanone

### - Alga growth inhibitiontest Bayer Industry Services,Leverhen, Germany Bayer CropScienceAG, Report No.: 2006/0032/03, EditionNumber: M-275954-0 1-1 Date: 28.07.2006 GLP unpublished Acute toxicity ofBY108330 (tech.) to larvaeof Chironomusriparius in a 48 h water-only study Bayer CropScienceAG, Report No.: EBFNX072, EditionNumber: M-262632-0 1-2 Date: 08.12.2005 GLP unpublished Acute toxicity ofBY1 08330-en01to larvae of Chironomusrigarius in a 48 h water-only study Bayer CropScienceAG, Report No.: EBFNX073, EditionNumber: M-262638-01-2 Date: 08.12.2005 GLP unpublished Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes

Yes Owner

BCS

BCS

BCS

BCS

BCS

BCSData Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes Annex point/ reference number or MRID Number IIA>.5.1

IIA 8.5.1

IIA 8.5.1

IIA 8.5.2

IIA 8.6 Owner

BCS

BCS

BCS

BCS

BCS Year

2006a

2007a

2007b

2005i

2005j Author@)

Dorgerloh, M.

Dorgerloh, M.

Dorgerloh, M.

Dorgerloh, M.

Dorgerloh, M. Title Source (where different from company) Company, Report No GLP or GEP status (whererelevant) Published or not Acute toxicity of BY1 08330-ketohydroxyto larvae of Chironomusriparius in a 48 h static laboratory test system Bayer CropScienceAG, Report No.: EBFN0347, EditionNumber: M-263956-01-2 Date: 16.01.2006 GLP unpublished Acute toxicity of 4-Methoxycyclohexanonto Larvae of Chironomusriparius in a 48 h static laboratory test system (Limit-Test) Bayer CropScienceAG, Report No.: EBFX104, EditionNumber: M-287218-01-1 Date: 27.04.2007 GLP unpublished Acute toxicity of BYI 08330-cis-methoxycyclohexylaminocarboxylic acid to Larvae of Chironomusriparius in a 48 h static laboratory test system (Limit-Test) Bayer CropScienceAG, Report No.: EBFX105, EditionNumber: M-287220-01-1 Date: 27.04.2007 GLP unpublished Chironomusriparius 28day chronic toxicity test with BYI 08330 (tech.) in a water-sediment systemusing spiked water Bayer CropScienceAG, Report No.: EBFN0050, Edition Number: M-248099-02-2 Date: 16.03.2005,Amended: 29.06.2006 GLP unpublished Lemna gibba G3 - Growth inhibition test with BYI 08330 (tech.) under static-renewaltest conditiom Bayer CropScienceAG, Report No.: DOM 24019, EditionNumber: M-255296-01-2 Date: 29.07.2005 GLP unpublishedAnnex point1 reference number or MRID Number IIA 8.6

IIA 8.7.1

IIA 8.7.4

IIA 8.7.4

IIA8.8.1.1 Author(s)

Dorgerloh, M.

Schmitzer, S.

Schur, A.

Schur, A.

Waltersdorfer,A. Year

2005k

2004

2004a

2004b

2005a Title Source (where different from company) Company, ReportNo GLP or GEP status (whererelevant) Published or not Lemnu gibba G3: Growth inhibitiontest with BY1 08330-en01under static conditions Bayer CropScienceAG, Report No.: EBFNXO65, Edition Number: M-252412-01-2 Date: 07.06.2005 GLP unpublished Effects of BYI 08330 (acute contact and oral) on honey bees (Apis mellifru L.) in the laboratory Ibcaon GmbH, Rossdorf, Germany Bayer CropScienceAG, Report No.: 20091035, EditionNumber: M-08 1227-01-2 Date: 12.07.2004 GLP unpublished Assessmentofthe side-effectsof BY1 08330 OD 100 on the honey bee (Apzi mellifru L.) in a feedingtest GAB Biotechnologie GmbH & IFU Umweltanalytik GmbH, Niefem-Oeschelbronn, Germany Bayer CropScienceAG, Report No.: 20031168101-BFEU, Edition Number: M-000345-01-2 Date: 23.02.2004 GLP unpublished also filed: IIIA2 10.4.2.1 also filed: IIIA2 10.4.2.2 Assessmentofthe sidseffects of BYI 08330 SC 240 on the honey bee (Apis mellifea L.) in a feeding test GAB GmbH, Niefem-Oeschelbrom, Germany Bayer CropScienceAG, Report No.: 2003 1166101-BFEU, Edition Number: M-12 1877-01-2 Date: 05.02.2004 GLP unpublished also fded:IIL43 10.4.2.1 Toxicityto the parasitoidwasp Aphidius rhopalosiphi (DeStephani-Perez)(Hymenoptera: Bracconidae) in the laboratory; BY108330 150 OD; Code: AE 130294300 OD15 A101 Bayer CropScienceAG, Report No.: CW051023, EditionNumber: M-254442-01-1 Date: 15.07.2005 GLP unpublished Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes Owner

BCS

BCS

BCS

BCS

BCSOwner

BCS

BCS

BCS

BCS Data Protection Claimed YIN-R/NR Yes

Yes

Yes

Yes Annex point/ reference number or MRID Number IIA 8.8.1.2

IIA 8.8.2.1

IIA 8.8.2.2

IIA 8.8.2.4 Year

2005b

2006a

200%

2005 Author(s)

Waltersdorfer, A.

Waltersdorfer,A.

Waltersdorfer,A.

Roehlig, U. Title Source (where different from company) Company, Report No GLP or GEP status (whererelevant) Published or not Toxicityto thepredatory mite Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the laboratory, BY1 08330 150 OD; Code AE 130294300 OD15 A101 Bayer CropScienceGmbH, FranlGurt am Main, G-Y Bayer CropScienceAG, Report No.: CW051024, EditionNumber: M-254269-0 1-1 Date: 12.07.2005 GLP unpublished Toxicity to the parasitoidwaspAphidius rhopalosiphi (DeStephani-Perez) (Hymenoptera: Braconidae)using an extended laboratory test with BY108330 150 OD Bayer CropScienceGmbH, Fraalurt am Main, Germany Bayer CropScienceAG, Report No.: CW05/071, EditionNumber: M-2641794 1-1 Date: 18.01.2006 GLP unpublished Toxicity to the predatory mite Typhlodromuspyn' SCHEUTEN (Acari, Phytoseiidae) using an extended laboratory test BY108330 150 OD Bayer CropScienceGmbH, Frankfurtam Main, Germany Bayer CropScienceAG, Report No.: CW051030, EditionNumber: M-25630641-1 Date: 25.08.2005 GLP unpublished Dose-response toxicity (LR50) of BY108330 150 OD to the green lacewing Chrysoperlacarnea (STEPH.) under extendedlaboratory conditions (includingfoodapplication) BioChem agrar, Gerichshain,Germany Bayer CropScienceAG, Report No.: 051048082, Edition Number: M-26265041-1 Date: 14.12.2005 GLP unpublishedOwner

BCS

BCS

BCS

BCS

BCS

BCS 

# I Data Protection Claimed Y/N-RlNR Yes

Yes

Yes

Yes

Yes

Yes Title Source (where different from company) Company, Report No GLP or GEP status (whererelevant) Published or not Toxicityto the ladybird Coccinella septempunctataL. (Coleoptera, Coccinellidae) using an extended laboratory test including exposure to and oral uptake of BY108330 150 OD Bayer CropScienceGmbH, FranlGurtam Main, Germany Bayer CropScienceAG, ReportNo.: CW051053, EditionNumber: M-264175-01-1 Date: 18.01.2006 GLP unpublished BYI 08830 (tech.): Acute toxicity to earthworms (Eiseniafetida)tested in artifical soil with 5 %peat Bayer CropScienceAG, Report No.: LKCRG-A-18/03, EditionNumber: M-104 105-01-2 Date: 07.01.2004 GLP unpublished BYI 08330-cis-ketohydroxy: Acute toxicity to earthworms (Eiseniafetida)tested in artificial soil Bayer CropScienceAG, ReportNo.: LKCIRG-A-47105, Report includes TrialNos.: Rg08105 EditionNumber: M-258925-01-2 Date: 17.10.2005 GLP, unpublished BY108330-Enol: Reproduction toxicity to the earthwormEisenidafetida in artificial soil ECT Oekotoxikologie GmbH, Floersheim, Germany Bayer CropScienceAG, Report No.: P18RR, EditionNumber: M-243305-0 1-2 Date: 19.01.2005 GLP, unpublished Spirotetramat- 4-methoxycyclohexanon:Acute toxicity to earthworms (Eiseniafetida) tested in artificial soil with 5 percent peat Bayer CropScienceAG, Report No.: LRT-RG-A-98/07, Edition Number: M-296072-01-1 Date: 09.01.2008 GLP, unpublished BY108330 tech.: Determinationof effects on nitrogen transformationin soil Bayer CropScienceAG, Report NO.:LKC-N-32104, EditionNumber:M-087831-01-1 Date: 01.09.2004 GLP, unpublished Year

2006b

2004a

2005

2005

2008

2004b Annex point1 reference number or MRID Number 11.4 8.8.2.4

IIA 8.9.1

IIA 8.9.1

IIA 8.9.1

IIA 8.9.1

IIA 8.10.1 Author@)

Waltersdorfer, A.

Lechelt-Kunze, C.

Lechelt-Kunze, C.

Moser, T.; Scheffczyk,A.

Leicher, T.

Lechelt-Kunze,C.Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes Annex point1 reference number or MIUD Number IIA 8.10.1

IIA 8.11.1

IIA 8.11.1

IIA 8.11.1

IIA 8.11.1 Owner

BCS

BCS

BCS

Springborn

BCS Year

2004c

2005

2005a

2005b

2006 Author@)

Lechelt-Kunze, C.

Banman, C. S.; Lam, C. V.

Cafarelle,M. A.

Cafarella, M. A.

Banman, C. S.; Lam, C. V. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not BYl08330 tech.: Determinationof effects on carbon transformationin soil Bayer CropScienceAG, ReportNO.:LKC-C-30104, EditionNumber: M-087840-01-1 Date: 01.09.2004 GLP, unpublished Acute toxicity of BY108330 technical to the sheepsheadminnow (Cyprinodon variegatus)under flow-trough conditions Bayer Cropscience, Stilwell, KS, USA Bayer CropScienceAG, ReportNo.: EBFNXOOG, EditionNumber: M-255363-01-1 Date: 27.07.2005 GLP unpublished BY108330 

### - Acute toxicity to mysids (Americamysis bahia) under flow-through conditions SpringbornSmithersLaboratories, Wareham, MA, USA Bayer CropScienceAG, Report No.: EBFNXOIO, EditionNumber: M-270200-01-1 Date: 06.01.2005 GLP unpublished BY108330 - Acute toxicity to eastern oysters (Crassostvea virginica)under flow-through conditions SpringbornSmithers Laboratories, Inc., Wareham, MA, USA Bayer CropScienceAG, Report No.: EBFNXO 11, EditionNumber: M-257677-01-1 Date: 15.06.2005 GLP unpublished Toxicityof BY108330 technical to the saltwater diatom Skeletonema costatum Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, ReportNo.: EBFNXOO9-1, Edition Number: M-271037-02-1 Date: 23.02.2006, Amended: 16.06.2006 GLP unpublishedOwner

BCS

BCS

BCS

BCS

BCS Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes Annex point1 reference number or MRID Number IIA 8.12

IIA 8.12

IIA 8.12

IIA 8.12

IIA 8.12 Year

2006a

2006a

2006

2006b

2006b Author@)

Gosch, H.; Nguyen, D.H.

Christ, M. T.; C. V.

Friedrich, S.

Gosch, H.; Nguyen, D.H.

Christ, M. T.; Lam, C. V. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not Non-target tarestrial plants: an evaluation of the effects ofBY108330 OD 150in the vegetative vigour test (Tier 1) Bayer CropScienceGmbH, FrankfUrt am Main, Germany Bayer CropScienceAG, Report No.: W06103, Edition Number: M-273381-01-1 Date: 20.06.2006 Non GLP unpublished Tier I and Tier II - Vegetative vigor non-target plant study using BY108330 150 OD Bayer CropScience, Stilwell, KS, USA Bayer CropScienceAG, Report No.: EBFNX016, EditionNumber: M-276131-01-1 Date: 09.08.2006 GLP unpublished SpirotetramatOD 150: Vegetative vigour test on nontarget terrestrial plants BioChem agrar, Gerichshain,Germany Bayer CropScienceAG, ReportNo.: 061048126, Edition Number: M-279698-01-1 Date: 30.10.2006 GL? unpublished Non-target terrestrialplants: an evaluation ofthe effects ofBYI 08330 OD 150inthe seedling emergenceand growth test (Tier 1). Bayer CropScienceGmbH, Fmnkfurt am Main, Germany Bayer CropScienceAG, Report No.: SE06103, EditionNumber: M-273373-01-1 Date: 20.06.2006 Non GLP unpublished Tier I seedling emergence- Non-target plant study using BYI 08330 150 OD Bayer CropScience,Stilwell,KS, USA Bayer CropScienceAG, ReportNo.: EBFNX017, Edition Number: M-276244-01-1 Date: 09.08.2006 GLP unpublishedAnnex point/ reference number or MRID Number IL4 8.14

IL4 8.15

ILA 8.16

Annex Dl Data and IDA1 10.1.2

IDA1 10.1.2

mAl 10.1.2 Year

2005

2004

2008

2006

2008

2008 Author@)

Moser, T.; Scheffczyk A.

Bruns; Caspers, N.

Schneider, K

Information Wolf, C.; Gerlach,J.

Ebeling, M. Kyriazi, K

Wikem, S., Schneider, K. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not BY108330-Enol: Effects on survival and reproduction of the predaceous miteHypoaspis aculeife Canestrhi (Acari: Laelapidae) in standard soil (LUFA2.1) ECT Oekotoxikologie GmbH, Floersheim,Germany Bayer CropScienceAG, ReportNo.: P1lHR, EditionNumber: M-243307-0 1-1 Date: 19.01.2005 GLP unpublished BYi 08330 - Toxicity to bacteria Bayer Industry ServicesGmbH, Leverkusen, Germany Bayer CropScienceAG, ReportNo.: 1312N/04 B, Edition Number: M-275364-01-1 Date: 05.10.2004 GLP unpublished Residues of Spirotetramatin arthropods after spray applicationin citrus 

### - magnitude and time course of residue decline RIFCON GmbH, Heidelberg, Germany Bayer CropScienceAG, ReportNo.: RAO7-03 1, Edition Number: M-296043-01-1 Date: 09.01.2008 GLP, unpublished Insectivorous birds in southern European citrus plantations focal species and their diet composition RIFCON GmbH, Hirschberg,Germany Bayer CropScienceAG, ReportNo.: RC06-067, Edition Number: M-277503-01-1 Date: 15.09.2006 Non GLP unpublished Refinement for the risk assessment for the Great Tit in citrus orchards followingtreatment with Spirotetramat Bayer CropScienceAG, EditionNumber: not yet fmlised Non GLP, unpublished Residues of Spirotetmnatin arthropods after spray application in citrus - magnitude and time comeof residue decline RIFCON GmbH, Heidelberg,Germany Bayer CropScienceAG, ReportNo.: RA07-03 1, Edition Number: M-296043-01-2 Date: 09.01.2008 GLP, unpublished Data Protection Claimed Y/N-R/NR Yes

Yes

Yes

Yes

Yes

Yes Owner

BCS

BCS

BCS

BCS

BCS

BCSData Protection Claimed YIN-R/NR Yes

Yes

Yes

Yes

Yes Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not BY108330 150 OD - Magnitudeof the residue idon soybeanslwheat, potential wildlife feed items Bayer CropScience, Stilweu,KS, USA Bayer CropScienceAG, Report No.: RAFNP002, EditionNumber: M-2773 15-01-1 Date: 06.09.2006 GLP unpublished Genericfieldmonitoring of birds inpotato cultivation innorthern Germany Bayer CropScienceAG, Report No.: WFC/FS 019, EditionNumber: M-090336-02-1 Date: 29.09.2004, Amended: 04.01.2005 GLP unpublished Acute toxicity of BY108330 OD 150 to fish (Oncorhynchus mykiss)under static conditions Bayer CropScienceGmbH, Monheim, Germany Bayer CropScienceAG, Report No.: EBFNMOO8, Edition Number: M-253916-01-2 Date: 29.06.2005 GLP, unpublished Acute toxicity of BY108330 OD 150to larvae of Chironomusriparius in a 48 h static laboratory test system Bayer CropScienceAG, Report No.: EBFNM007, Edition Number: M-2640 18-01-2 Date: 19.01.2006 GLP, unpublished Pseudokirchneriella subcapitata growth inhibition test with BYI 08330 OD 150 Bayer CropScienceAG, Report No.: EBFNM006, EditionNumber: M-264263-01-2 Date: 16.01.2006 GLP unpublished Owner

BCS

BCS

BCS

BCS

BCS Year

2006

2004

2005d

2006d

2006c Annex point/ reference number or MRID Number IIIA1 10.1.7 MRID 46904507

IDA1 10.1.7

IIIA 10.2.2.1

IIIA 10.2.2.2

IIIA 10.2.2.3 Author(s)

Fischer, D. R., Ramanarayanan,T. & Ortegoy L'

Wolf, C.

Nieden, D.

Dorgerloh, M.

Dorgerloh, M.Annex point1 reference number or MRID Number EL41 10.3.1.3

JIM1 10.4.2

EL41 10.4.2.1

IIIA1 10.4.2.2

EL41 10.4.5 Year

2005

2005a

2005b

2005

2006 Author@)

G.D. Cappon, T.L. Fleeman, R.E. Chapin, and M.E. Hurtt

Barth, M.

Barth, M.

Earth, M.

Schur, A. Title Source (where different from company) Company, Report No GLP or GEP status (where relevant) Published or not Effects of feed restriction during organogenesis on embryo-fetaldevelopment in rabbit Publisher:2005Wiley-Liss, Inc., JodBirth Defects Research (Part B), Volume:74, Pages:424430, Year:2005, Report No.: Lit. 8639, EditionNumber: M-274544-01-1 Non GLP published Acute toxicity ofBYI 08330 150 OD to the honeybee Apis mellifru L. under laboratory conditions BioChem agrar, Gerichshrun, Germany Bayer CropScienceAG, Report No.: 051048032, Edition Number: M-25912241-2 Date: 18.10.2005 GLP unpublished Acute toxicity of BYI 08330 150 OD to the honeybee Apis mellifeu L. under laboratory conditions BioChem agrar, Gerichshain,Germany Bayer CropScienceAG, ReportNo.: 051048032, Edition Number: M-25912241-2 Date: 18.10.2005 GLF' unpublished Acute toxicity of BYI 08330 150 OD to the honeybee Apis mellifra L. under laboratory conditions BioChem agrar, Gerichshain,Germany Bayer CropScienceAG, Report No.: 05 1048032, EditionNumber: M-259122-01-2 Date: 18.10.2005 GLP unpublished Assessmentof side effects of SpirotetramatOD 150 on the honey bee (Apis mellifru L.) in the field eurofm-GAB GmbH, ~iefern-~schelbronn, Germany Bayer CropScienceAG, Report No.: 20061133lS1-BFEU, Edition Number: M-277 194-02-2 Date: 11.09.2006 GLP unpublished Data Protection Claimed Y/N-R/NR No

Yes

Yes

Yes

Yes Owner

BioChem

BioChem

BioChem

BCSData Protection Claimed Y/N-RiNR Yes

Yes

Yes

Yes

Yes Title Source (where different from company) Company, Report No GLP or GEP status (whererelevant) Published or not Assessment of side effects of BY1 08330 OD 100 on the honey bee (Apis mellifeva L.) in the semi-field GAB GmbH, Niefan-Oeschelbronn,Germany Bayer CropScienceAG, Report No.: 20041144101-BZEU, Edition Number: M-244490-01-2 Date: 02.02.2005 GLP unpublished Summaryof orientating research tunnel aials on effects of spirotetramatto honey bees according to EPPO 170 RIFCon GmbH, Leichlingen, Germany Bayer CropScienceAG, Report No.: PA07-174, EditionNumber: M-2942 16-01-1 Date: 17.10.2007 Non GLP, unpublished BY108330 150 OD; Toxicity to the predatory mite Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) using an extended laboratory test (under semi-field conditionsaged residues on apple trees); AE 1302943 00 OD15 A101 Bayer CropScienceGmbH, Frankfkt am Main, Germany Bayer CropScienceAG, Report No.: CW051028, EditionNumber: M-264153-01-1 Date: 18.01.2006 GLP unpublished Evaluating effects of BY1 08330 OD 150 applications on mite fauna (Acari) in the field (grape vines, France) MITOX Consultants,Amsterdam, The Netherlands Bayer CropscienceAG, ReportNo.: B127AFG, Edition Number: M-269107-01-1 Date: 14.03.2006 GLP unpublished SpirotetramatSC 240 g/L+ (InertIngredient): Effects on the Vegetative Vigour ofthe Non-Target Terrestial Plant Shattercane (Tier 2). ProjectNumber: Wl071034, EBFNXI 11, Ml28861210111. Unpublished study preparedby Bayer Cropscience Gmbh. Owner

BCS

BCS

BCS

Mitox

BCS Year

2005

2007

2006c

2006

2007 Annex point1 reference number or MRID Number mAl 10.4.7

mA1 10.4.7

JJIAl 10.5.2

mA1 10.5.4

Not included in

monograph.

MRID 47167902 Author(s)

Schur, A.

Koelzer, U.

Waltersdorfer, A.

Aldershof, S.A.

Gosch, H.

### Ecolo~ical Effects Studies As Or~anized According:to Guideline Number in OPPIN at the Completionof This Risk Assessment Guideline: 71-2 Avian Dietary Toxicity MRID: 46904446 Stoughton, T. (2006) TechnicalBYI 08330: A Subacute Dietary LC50 with Mallards. ProjectNumber: EBFNXO12, M/274385/01/1. Unpublished study prepared by Bayer CropScience LP. 52 p. 

### Guideline: 71-4 Avian Reproduction MRID: 46904434 Temple, D.; Martin, K.; 

### Beavers, 

### J.; et. al. (2006) BYI 08330 Technical: A Reproduction Studywith the Mallard. Project Number: 1491208,EBFNP024. Unpublished study prepared by Wildlife International, Ltd. 162p. MRID: 46904447 Sabbert, T.; Nuessle, C. (2004) Effect of Technical BYI 08330 on Northern Bobwhite Reproduction. Project Number: EBFN0220, M/277757/01/1. Unpublished studyprepared by Bayer CropScienceLP. 138p. MRID: 46904448 Sabbert, T.; Nuessle, C. (2005) Effect of Technical BYI 08330 on Mallard Reproduction. Project Number: EBFNX013, MY27779410112. Unpublished study prepared by Bayer CropscienceLP. 154p. 

### Guideline: 72-1 Acute Toxicity to Freshwater Fish MRID: 46904438 Dorgerloh, M. (2004)Acute Toxicity of BYI 08330 (tech.)to Fish (Onchorhynchusmykiss). Project Number: DOMY24025, E12801269411, MI18264910112. Unpublished studyprepared by Bayer Ag. 52 p. MRID: 46904439 Dorgerloh, M. (2005)Acute Toxicity of BY1 08330 (tech.) to Fish (Lepomis macrochirus). Project Number: DOMY24056, El280/2747/0,MI24268910 112. Unpublished studyprepared by Bayer Ag. 53 p. MRlD: 46904460 Nieden, D. (2005)Acute Toxicity of BY1 08330 OD 150to Fish (Onchorhynchusmykiss) Under Static Conditions. Project Number: EBFNMOO8, El2801293519. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 51 p. MRID: 46904468 Dorgerloh, M. (2006)Acute Toxicity of BYI 08330 SC 240 

### + RME to Fish (Oncorhynchus mykiss) Under Static Conditions. Project Number: 2137 1035. Unpublished studyprepared by Bayer CropscienceGmbh. 54 p. MRID: 46904469 Dorgerloh, M. (2005) Effects of BY1 08330 240 SC (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) 

### in the Laboratory. ProjectNumber: 2003 116610 l/BFEU, ELECTRONICICOPY.

### Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 3 1p. MRID: 

### 46904475 Nieden, D. (2005) Acute Toxicity of BY1 08330-en01to Fish (Oncorhynchusmykiss). ProjectNumber: EBFNMO 13,El2801283417, Pl6841037060. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 72 p.

Guideline: 72-2 Acute Toxicity to Freshwater Invertebrates 

### MRTD: 46904435 Dorgerloh, M. 

### (2005)Acute Toxicity of BYI 08330 (tech.) to the Waterflea Daphnia magna Under Static Conditions. Project Number: E/320/2536/1,M/242683/0112, DOM124004. Unpublished study prepared by Bayer Ag. 44 p. MRID: 46904474 Dorgeloh, 

### M. (2005)Acute Toxicity of BYI 08330-en01to the Waterflea Daphnia magna in a Static Laboratory Test System. ProjectNumber: El320128 1218,EBFNMO 12. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 69 p. Guideline: 72-3 Acute Toxicity to EstuarineIMarine Organisms 

### MRID: 46904436 Cafarella, M. (2005) BY108330 

### - Acute Toxicity to Mysids (Americarnysis bahia) Under Flow-Through Conditions. Project Number: 1379816170,EBFNXO10, M/270200101/1. Unpublished studyprepared by

, 

### Springborn SmithersLaboratories. 53 p.

MRID: 46904437 Cafarella, 

### M. (2005) BYI 08330 

## - Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under FlowThrough Conditions. Project Number: 13798161 75, EBFNXO 11,M/257677/01/1. Unpublished study prepared by Springborn Smithers Laboratories. 54 p. MRID: 

### 46904440 Banman, C.; 

### Lam, C. (2005) Acute Toxicity of BY1 08330 Technical to the Sheepshead Minnow (Cyprinodon variegatus)Under Flow-Through Conditions. Project Number: EBFNX006, M/25536310111 Unpublished study preparedby Bayer CropscienceLP. 42 p. Guideline: 72-4 Fish Early Life StageIAquaticInvertebrateLife Cycle Study 

## ---- 

## .............................. MRID: 46904441 Dorgerloh, 

### M. (2005) Influence of BY1 08330 (tech.) on Development and Reproductive Output of the Waterflea Daphnia magna in 

### a Static Renewal Laboratory Test System. ProjectNumber: EBFN0245, El3211253713, MI25 184310112. Unpublished studyprepared by Bayer Ag. 61 p. MRID: 

### 46904442 Dorgerloh, M. 

### (2005) Early-Life Stage Toxicity of BYI 08330 tech. to Fish (Pimephales promelas). Project Number: EBFN0305, E/284/2681/1,M/260676/0112. Unpublished studyprepared by Bayer Ag.

### 96 p.

Guideline: 122-1 Seed GerminatiodseedlineEmergence and Vegetable Vigor MRID: 46904463 Christ, M.; Lam, C. (2006) Tier I Seedling Emergence Non-Target Plant StudyUsing BYI 08330 150 OD. Project Number: EBFNX017. Unpublished study prepared by Bayer Corp. 43 p. MRID: 46904464 Christ, M.; Lam, C. (2006) Tier I and Tier 

### IIVegetative Vigor Non-Target Plant Study Using BYI 08330 150 OD. Project Number: EBFNXO 16. Unpublished studyprepared by Bayer Corp. 55 p. MRID: 47330401 Ortego, L.; Nguyen, D.; Christ, M. (2008) Response to AGESAJS EPA Request for Additional Analysis of Study No. EBFNX016 Tier I and Tier 11

### Vegetative Vigor Non-Target Plant Study Using BYI 08330 150 OD. Project Number: G20 1 

### 834. Unpublished studyprepared by Bayer CropScience LP. 15 p. Guideline: 122-2 Aquatic plant growth MRID: 46904451 Dorgerloh, M. (2004) Pseudokirchneriella subcapitata 

## - Growth Inhibition Test with BYI 08330 (tech.). Project Number: DOMl23092, El3231260612, P6041047065. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Ana. 129p. Guideline: 123-1 Seed germinationheedling emergence and vegitative vigor MRID: 46904464 Christ, M.; Lam, C. (2006) Tier I and Tier 

### II Vegetative Vigor Non-Target Plant Study Using BY1 08330 150 OD. Project Number: EBFNXO 16. Unpublished studyprepared by Bayer Corp. 55 p. MRID: 47330401 Ortego, L.; Nguyen, D.; Christ, M. (2008) Responseto AGESAJS EPA Request for Additional Analysis of StudyNo. EBFNXO 16Tier I and Tier 11

### Vegetative Vigor Non-Target Plant Study Using BY1 08330 150 OD. Project Number: G20 1834. Unpublished studyprepared by Bayer CropScience LP. 15p. Guideline: 123-2 Aquatic plant growth MRID: 46904451 Dorgerloh, M. (2004) Pseudokirchneriella subcapitata 

### - Growth InhibitionTest with BY1 08330 (tech.). Project Number: DOMl23092, El3231260612, P6041047065. Unpublished studyprepared by Bayer Ag, Instituteof Product Info. & 

### Residue Ana. 129p.
MRID: 46904452 Kern, M.; Lam, C. (2006) Toxicity of BYI 08330 Technical to the Blue-Green Alage Anabaena flosaquae. Project Number: EBFNX007. Unpublished studyprepared by Bayer Corp. 50 p.

### MRID: 46904453 

### Kern, M.; Lam, C. (2005) Toxicity of BY1 08330 to the Freshwater Diatom Navicula pelliculosa. Project Number: EBFNX008. Unpublished study prepared by Bayer Corp. 52 p. MRID: 46904454 Banman, C.; Lam, C. (2006) Toxicity of BY1 08330 Technical to the Saltwater Diatom Skeletonema costaturn. Project Number: EBFNX00911. Unpublished study prepared by Bayer Corp. 50 p. Guideline: 850.1010 Aquatic invertebrate acute toxicity, test, 

### Fw daphnids



## ........................................................................... MRID: 46904435 Dorgerloh, 

### M. (2005) Acute Toxicity of BY1 08330 (tech.) to the Waterflea Daphnia magna Under Static Conditions. Project Number: El320/2536/1, W24268310112, DOW24004. Unpublished study prepared by Bayer Ag. 44 p. MRID: 46904474 Dorgeloh, M. (2005) Acute Toxicity of BY1 08330-en01to the Waterflea Daphnia magna 

### in a Static Laboratory Test System. Project Number: El320128 1218,EBFNMO 12. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 69 p. Guideline: 850.1025 Oyster acute toxicity test (shell deposition)



## ........................................................................... MRID: 46904437 Cafarella, M. (2005) BYI 08330 

### - Acute Toxicity to Eastern Oyster (Crassostreavirginica) Under FlowThrough Conditions. Project Number: 1379816175,EBFNXO11, M/257677/01/1. Unpublished study prepared by Springborn SmithersLaboratories. 54 

### p. Guideline: 850.1035 Mysid acute toxicity test MRID: 46904436 Cafarella, M. (2005) BYI 08330 

### - Acute Toxicity to Mysids (Americamysis bahia) Under Flow-Through Conditions. Project Number: 1379816170,EBFNXO10, M/270200/01/1. Unpublished studyprepared by Springborn Smithers Laboratories. 53 p.

Guideline: 850.1075 Fish acute toxicity test, freshwater and marine MRID: 46904438 Dorgerloh, M. (2004) Acute Toxicity of BYI 08330 (tech.) to Fish (Onchorhynchusmykiss). Project Number: DOW24025, E/280/2694/1, W18264910 112. Unpublished study prepared by Bayer Ag. 52 p. MRID: 46904439 Dorgerloh, M. (2005) Acute Toxicity of BY1 08330 (tech.) to Fish (Lepomis macrochirus). Project Number: DOW24056, E1280/274710, W24268910112. Unpublished study prepared by Bayer Ag. 53 p. MRID: 46904440

### Banman, C.; Lam, C. (2005) Acute Toxicity of BY1 08330 Technicalto the Sheepshead Minnow (Cyprinodon variegatus) Under Flow-Through Conditions. Project Number: EBFNX006, M/255363/01/1. Unpublished studyprepared by Bayer Cropscience LP. 42 p. MRID: 46904460 Nieden, D. (2005) Acute Toxicity of BY1 08330 OD 150 to Fish (Onchorhynchusmykiss) Under Static Conditions. ProjectNumber: EBFNM008, El2801293519. Unpublished study prepared by Bayer Ag, Institute of Product Irifo. & 

### Residue Anal. 5 1 p. MRID: 46904469 Dorgerloh, M. (2005) Effects of BY1 08330 240 SC (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory. Project Number: 20031 166/01/BFEU,ELECTRONICICOPY. Unpublished studyprepared by ArbeitsgemeinschaftGAB 

### Biotechnologie. 3 1 p. MRID: 46904475 Nieden, D. (2005) Acute Toxicity of BY1 08330-en01to Fish (Oncorhynchusmykiss). Project Number: EBFNMO 13, El2801283417, PI6841037060. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 72 p. Guideline: 850.1300 Daphnid chronic toxicity test



## ............................................................................. MRID: 46904441 Dorgerloh, M. (2005) Influence of BYI 08330 (tech.) on Development and Reproductive Output of the Watefflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: EBFN0245, El3211253713, MI25 184310112. Unpublished studyprepared by Bayer Ag. 6 1p.

Guideline: 850.1400 Fish early-lifestage toxicity test MRID: 46904442 Dorgerloh, M. (2005) Early-Life Stage Toxicity of BYI 08330 tech. to Fish (Pimephalespromelas). Project Number: EBFN0305, El2841268 111, MI26067610 112. Unpublished study prepared by Bayer Ag. 96 p. Guideline: 850.2100 Avian acute oral toxicity test MRID: 46904444 Barhecht, R. (2003) Acute Oral Toxicity for Bobwhite Quail (Colinus virgianus) for the Test Item BY108330 (tech.). Project Number: BAR/LD/47, El2041252914,MI1 159 1110212. Unpublished study prepared by Bayer Ag. 41 p. Guideline: 850.2200 Avian dietary toxicity test

- ................................... 

### MRID: 46904445 Barfknecht, R. (2004) BYI 08330 techn. a.s. :

### 5-Day-Dietary LC50 Bobwhite Quail (Colinus virgianus). Project Number: BAR/LC017, E/206/2612/9, M/084796/01/2. Unpublished studyprepared by Bayer Ag. 44 p.

### MRID: 46904446 Stoughton, T. (2006) TechnicalBY1 08330: A SubacuteDietary LC50 with Mallards. ProjectNumber: EBFNXO 12,MI27438510 111. Unpublished studyprepared by Bayer CropScience LP. 52 p. Guideline: 850.2300 Avian reproductiontest MRID: 

### 46904434 Temple, D.; Martin, K.; Beavers, J.; 

### et. al. (2006) BY1 08330 Technical: A Reproduction Studywith the Mallard. Project Number: 1491208,EBFNP024. Unpublished studyprepared by Wildlife International, Ltd. 162p. MRID: 46904447 Sabbert, T.; Nuessle, C. (2004) Effect of Technical BYI 08330 on Northern Bobwhite Reproduction. Project Number: EBFN0220, M/277757/01/1. Unpublished studyprepared by Bayer CropScienceLP. 138p. MRID: 46904448 Sabbert, T.; Nuessle, C. (2005) Effect of Technical BYI 08330 on Mallard Reproduction. Project Number: EBFNXO 13,MI27779410112. Unpublished studyprepared by Bayer CropscienceLP. 154p. Guideline: 850.3020 Honey bee acute contact toxicity 

### MRID: 46904449 Schmitzer, S. 

### (2004) Effects of BYI 08330 (Acute Contact and Oral) on Honey Bees (Apis melliferaL.) in the Laboratory. Project Number: 20091035, MI08 122710112. Unpublished studyprepared by Institut 

### fUer Biologische Analytikund ConsultingIBACON. 26 p. Guideline: 850.3040 Field testing for pollinators 

### MRID: 46904462 Schur, A. (2006)Assessmnet of Side Effects of Spirotetramat OD 150 on the Honey Bee (Apis mellifera L.) in the Field: Final Report. Project Number: 20061 133lSllBFEU. Unpublished studyprepared by ArbeitsgemeinschaftGAB Biotechnologie. 57 p. Guideline: 850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor) 

### MRID: 47202101 Friedrich, S. (2006) Spirotetramat OD 150: Vegetative Vigour Test on Non-Target TerrestrialPlants: Final Report. Project Number: 06/10148/126. Unpublished studyprepared by Biochem Agrar, Lab her Biologische und Chemische. 35 p. MRID: 47381301 Bach, F.; Nguyen, D.; Gosch, H. (2006)Non-Target Terrestrial Plants: An 

### Evaluation of the Effects of Spirotetramat SC 240glL (BYI 08330 SC 240) +0.2% RME EW 500 

### (AE 0297441 00 1R81A102) in the Vegetative Vigour Test (Tier 1). ProjectNumber: W06/09,08330, EBFNX103. Unpublished study prepared by Bayer CropscienceGmbh. 17p.

### Guideline: 850.4250 Vegetative vigor, Tier 11 

### MRID: 47167902 Gosch, 

### H. (2007) Spirotetramat SC 240 glL 

## + (Inert Ingredient): Effects on the Vegetative Vigour of the Non-Target Terrestial Plant Shattercane (Tier 2). Project Number: VVl071034, EBFNXl11, MI28861210111. Unpublished study prepared by Bayer Cropscience Gmbh. 48 p. 

### Guideline: 850.4400 Aquatic plant toxicity test using Lemna spp. Tiers 

### I and 

### II



## ............................................................................... MRID: 46904450 Dorgerloh, M. (2005) Lemna gibba G3: Growth Inhibition Test with 

### BY1 08330 (Tech.) Under StaticRenewal Test Conditions. Project Number: DOMl24019, El4121267618. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & Residue Anal. 144p. MRID: 46904476 Dorgerloh, M. (2005) Lemna gibba G3: Growth Inhibition Test with BYI 08330-en01Under Static Conditions. Project Number: EBFNX065, El4 121287610,MR113 1103. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & Residue Anal. 120p. 

### Guideline: 850.5400 Algal toxicity, Tiers 1 and 

### I1 MRID: 46904452 Kern, M.; Lam, C. (2006) Toxicity of BYI 08330 Technical to the Blue-Green Alage Anabaena flosaquae. Project Number: EBFNX007. Unpublished study prepared by Bayer Corp. 50 p. MRID: 46904453 Kern, M.; Lam, C. (2005) Toxicity of BYI 08330 to the Freshwater Diatom Navicula pelliculosa. Project Number: EBFNX008. Unpublished study prepared by Bayer Corp. 52 p. MRID: 46904465 Dorgerloh, M. (2006) Pseudokirchneriella subcapitataGrowth Inhibition Test with the BYI 08330 OD 150. Project Number: EBFNM006, El3231294114. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 81 p. MRID: 46904477 Dorgerloh, M. (2005) Pseudokirchneriella subcapitataGrowth Inhibition Test with BYI 08330-enol. Project Number: EBFNMO10, E/323/2816/5,00836. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 94 p. 

### Guideline: 870.1100 Acute oral toxicity MRID: 46904527 Eigenberg, D. (2004) An Acute Oral LD50 Study

### in the Rat with BYI08330. Project Number: 02IA12lNQ. Unpublished study prepared by Bayer Corp. 19p. MRID: 46904576 Schungel, M. (2005) BYI 08330 150 OD: Acute Toxicity 

### in the Rat After Oral Administration. Project Number: Tl0075503, AT021 61. Unpublished studyprepared by Bayer Ag Inst. of Toxicology. 24 p.

### MRID: 46904585 Schungel, M. (2005)BY1 08330 240 SC: Acute Toxicity in the Rat after Oral Administration. Project Number: AT02162, Tl2075523. Unpublished studyprepared by Bayer Ag Inst. of Toxicology. 24 p. MRID: 46904593 Schungel, M. (2005) Acute Toxicity in the Rat after Oral Administration of BY1 08330. ProjectNumber: T1075865. Unpublished studyprepared by Bayer Ag Inst. of Toxicology. 24 p. MRID: 

### 46904596 Schungel,

### M. (2006)Acute Toxicity in the Rat after Oral Administration of BY1 08330. ProjectNumber: T9076402. Unpublished studyprepared by Bayer Ag Inst. of Toxicology. 27 p. MRID: 46904598 Schungel,

### M. (2006)Acute Toxicity in the Rat after Oral Administration of BY1 08330. ProjectNumber: T3076767. Unpublished studyprepared by Bayer Ag Inst. of Toxicology. 26 p. MRID: 46904603 Schungel,M. (2005)Acute Toxicityin the Rat After Oral Administration: BYI 08330-mono-hydroxy. Project Number: Tl2076045, AT02687. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 24 P

## . Guideline: 870.3800 Reproduction and fertility effects 

### MRID: 46904546 Young, 

### A. (2006) Revised Report: BYI 08330: Reproduction and FertilityEffects Study of Rat. Project Number: 20142611. Unpublished studyprepared by Bayer Corp. 1565p. Guideline: 850.6200 Earthworm subchronic toxicity test 

### MRID: 47319101 Leicher, T. (2008) Spirotetramat

### - 4-Methoxycyclohexanon: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil With 5% Peat. Project Number: El3 101341113, LRT/RGlAl98/07, RGl37107. Unpublished studyprepared by Bayer Cropscience. 24 p. Non-Guideline Study

---- 

### MRID: 46904443 Citation: Dorgerloh, M. (2005) Chironomus riparius 28-Day Chronic Toxicity Test with BY1 08330 (tech.) in a Water-Sediment SystemUsing Spiked Water. Project Number: EBFN0050, El4 16/281315, M/248099/02/2. Unpublished studyprepared by Bayer Ag. 87 p. MRID: 46904455 I 

### Citation: Lechelt-Kunze, C. 

### (2004) BY1 08330 (tech.): Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil with 5% Peat. Project Number: El31012552/8, LKC/RG/A/l8/03. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 23 

### p. MRID: 46904456

### Citation: Dorgerloh,

### M. (2005)Acute Toxicity of BYI 08330 (tech.)to Larvae of Chironomus riparius in a 48 h Water-Only Study. Project Number: EBFNX072, El3221292717, B6841037060. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 

### 83 p. MRID: 46904458 Citation: Schur, A. (2004) Assessment of the Side-Effects of BYI 08330 OD 100 on the Honey Bee (Apis mellifera L.) in a Feeding Test: Final Report. Project Number: 2003 11 68/01/BFEU. Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 85 p. MRID: 46904459 Citation: Schur, A. (2005) Assessment of Side Effects of BYI 08330 OD 100 on the Honey Bee (Apis mellifera L.) in the Semi-Field: Final Report. Project Number: 20041 144/01/BZEU. Unpublished study prepared by GAB BiotechnologieGmbh. 117p. MRID: 46904461 Citation: Barth, M. (2005) Acute Toxicity of BYI 08330 150 OD to the Honeybee Apis mellifera 

### L. Under Laboratory Conditions: Final Report. Project Number: 051101481032. Unpublished studyprepared by Biochem Agrar, Lab herBiologische und Chemische. 30 p. MRID: 46904466 Citation: Dorgerloh,M. (2006) Acute Toxicity of BY1 08330 OD 150 to Larvae of Chironomus riparius in a 48 h Static Laboratory Test System. Project Number: El3221293617, EBFNM007. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 80 p. MRID: 46904470 Citation: Schur, A. (2004) Assessment of the Side-Effects of BY1 08330 SC 240 on the Honey Bee (Apis mellifera L.) in a Feeding Test. Project Number: 20003 1166/01/BFEU. Unpublished studyprepared by ArbeitsgemeinschaftGAB Biotechnologie. 88 p. MRID: 46904471 Citation: Dorgerloh,M. (2006) Pseudokirchneriella subcapitata Growth InhibitionTest with BY1 08330 SC 240 & 

### RME. Project Number: EBFN0290, El3231288212, MRl13 1/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 92 p. MRID: 46904472 Citation: Lechelt-Kunze,C. (2005) BY1 08330-cis-ketohydroxy: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil. ProjectNumber: El3 101288416. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 23 p. MRID: 46904473 Citation: Dorgerloh, M. (2006) Acute Toxicity of BY1 08330-Ketohydroxy to Larvae of Chironomus riparius in a 48 h Static Laboratory Test System. ProjectNumber: EBFN0347, El3221292818, P/604/057004. Unpublished studyprepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 62 p. 

### MRID: 46904478 Citation: Dorgerloh,M. (2005)Acute Toxicity of BY1 08330-en01to Larvae of Chrionomus riparius in a 48 h Water-only Study. Project Number: EBFNX073, El3221292919, MR113 1103. Unpublished study prepared by Bayer Ag, Institute of Product Info. & 

### Residue Anal. 83 p.

### MRID: 46904507 Citation: Fischer, D. (2006)BY108330 150 OD: Magnitude of the Residue inton SybeanstWheat, Potential Wildlife Feed Items. ProjectNumber: RAFNP002, N106805. Unpublished study prepared by Bayer Cropscience LP, Bayer Corp. and Battelle. 264 p. Citation: Kennel, P. (2005) BYI 08330: Evaluation of the Potential ReproductiveToxicity in the Male Rat Following Daily Oral Administration by Gavage. Project Number: SAl04181. Unpublished study prepared by Bayer Cropscience. 196p. MRID: 46904571 Citation: Young, A. (2006) Technical Grade BYI 08330: A Dose Range-Finding Reproductive Toxicity Study in the Wistar Rat: Revised Report. ProjectNumber: 03P721S1, 20130011. Unpublished study prepared by Bayer Corp. and Charles River Laboratories. 543 p. MRID: 46904601 Citation: Tinwell, H. (2006) BYI 08330-ENOL: Exploratory 10-Day Toxicity Study in the Rat by Gavage. Project Number: SAl05323. Unpublished studyprepared by Bayer France. 50 p. MRID: 46904607 Citation: Lemke, 

### V. (2006)Evaluation of Acute and Chronic Dietary Exposure to BY108330 and Assessment of Potential Risk. ProjectNumber: RGFNYOO5. Unpublished studyprepared by Bayer Corp. 89 p. MRID: 47182302 Citation: Stafford, J. (2007) Long-term Mallard Duck Dermal Exposure to BY1 08330. ProjectNumber: 1379814114,EBFNP033. Unpublished studyprepared by Springborn Smithers Laboratories. 46 p. MRID: 47182303 Citation: Stafford, J. (2007) Semi-Field Study of the Effects of Dermal and Dietary Exposureto BY1 08330 in Mallard Ducks (Anas platyrhynchos). Project Number: 13798141

### 1 6, EBFNP034. Unpublished studyprepared by Springborn Smithers Laboratories. 119p. MRID: 47276901 Citation: Kolzer, U. (2007) Summary of Orientating Research Tunnel Trials on Effects of Spirotetramatto Honey Bees According to EPPO 170: Evaluation of Brood Effect Endpoints. Project Number: PA07174. Unpublished study prepared by RifCon GmbH &Bayer Cropscience Ag. 37 p. Additional Studies, Open Literature and GovernmentReuorts Discussed in Assessment 

### Burns, L.A. 2000. ExposureAnalysis Modeling System (EXAMS), Environmental Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Athens, GA. Carsel R.F., J.C.Itnhoff, P.R.Humme1, J.M.Cheplick and J.S.Donigian, Jr. 1997. PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in 

### Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; EnvironmentalResearch Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Athens, GA.Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994. Literaturereview and evaluation of the EPA foodchain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environ. Tox. And Chem. 13(9):1383-1391. Food and Agriculture Organization of the United Nations. FA0 PESTICIDE DISPOSAL SERIES 8. Assessing Soil Contamination: A Reference Manual. Appendix 2. Parameters of pesticides that influence processes in the soil. Editorial Group, FA0 Information Division: Rome, 2000. 

### h~://~~~.fao.org/DOCREP/003/X2570E/X2570E00.htm Hoerger, F. and E.E. Kenaga. 1972. Pesticide residues on plants: correlationof representative data as a basis for estimation of their magnitude in the environment. 

### IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxicology and Technology. Vol 1. George Theime Publishers, Stuttgart, Germany. pp. 9-28. 

### MRlD 46904508 Fischer, D. (2006) BY108330 100 OD and BY108330 240 SC: Magnitude of the Residue idon LeafyVegetables. Project Number: RAFNY002. Unpublished study prepared by Bayer Corp. 703 p. 

### MRID 46904509 Freeseman, P. (2006)BY1108330 100 OD and BY1108330 240 SC: Magnitude of the Residue idon Brassica Leafy Vegetables (Crop Subgroup 5A, Head and Stem Brassica, and 5B, Leafy Brassica Greens) Including Residue Reduction Information. Project Number: RAFNY003. Unpublished study prepared by Bayer Corp., Coastal Ag Research, Inc. and Bayer Cropscience. 606 p. U. S. Environmental Protection Agency. 1994.

### Pesticide Reregistration Rejection RateAnalysis: Ecological Effects. Office of Pesticide Programs. Washington,D.C. U.S. Environmental Protection Agency. 1998. Guidelines for EcologicalRisk Assessment. Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPAl630lR-951002F. April 1998. U.S. Environmental Protection Agency. 2000. Risk CharacterizationHandbook. Science Policy Council, U.S. Environmental Protection Agency, Washington, D.C. 20460. EPA 100-B-00-002. December 2000. U.S. Environmental Protection Agency. 2001. EcologicalRisk Assessor Orientation Package. Office of PesticidePrograms, Ecological Fate and Effects Division. Draft Version, August 2001. Washington, D.C. U.S. Environmental Protection Agency. 2002. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. Office of Prevention, Pesticides and Toxic Substances, Office of PesticidePrograms, Environmental Fate and Effects Division, Feb. 28,2002. Online at: 

### httu://www.e~a.e;ov/ovvefedl/models/water/input widance2 28 02.htmI U.S. Environmental Protection Agency. 2004. Overview of the Ecological SskAssessment Process in the Office of PesticidePrograms. Office of Prevention, Pesticides, and Toxic Substances. Office of Pesticide Programs. Washington, D.C. January 23,2004. httu://www.e~a. 

### rrov/esvp/consultation~ecorisk-overview.pdf

### US. Environmental Protection Agency. 2005. Generic Format and Guidancefor the Level I Screening Ecological Risk Assessments Conducted in the Environmental Fate and EffectsDivision. Office of Pesticide Programs, Washington, D.C. January 24,2005. U.S. Environmental Protection Agency. 2006. ECOTOX User Guide: ECOTOXicology Database System. Version 4.0. Available: http:/www.epa.g;ov/ecotox/ U.S. Environmental ProtectionAgency. 2006. Terrestrial Residue Exposure Model (T-REX). Office of Pesticide Programs, Environmental Fate and Effects Division. Washington, D.C. 

### httu://www.eva.~ov/oupefed1Imodelslterrestriall U.S. Environmental ProtectionAgency. 2006. TerrPlant: Exposureto Terrestrial Plants including Wetlands.Version 1.2.2. Office of PesticidePrograms, Environmental Fate and Effects Division. December 26,2006. Washington, D.C. U.S. EnvironmentalProtection Agency. 2007. Benchmark Dose Software, Version 1.4.lc. National Center for EnviromentalAssessment, Office of Research and Development. Washington, D.C. httu://www.epa.govlncealbmds U.S. Environmental ProtectionAgency. 2007. Electronic Code of Federal Regulations (e-CFR): Title 40 Protection of Environment, Part 

## 5 158.80 Acceptability of data. Updated July 16,2007.h~://ecfr.moaccess.g;ovlcgiltltextltextidx?c=ecfr&sid=bc2dedalfD8 1243 

### 8b6~5fac3554afe23&rrm=div5&view=text&node=40:23 .O. 1.1.9&idno= 40 

## - Willis, G.H., and L.L. McDowell. 1987. Pesticide Persistenceon Foliage in Reviews of Environmental Contamination and Toxicology. 100:23-73. Willis and McDowell 1987, as cited in Carsel, R.F., et.al., "PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil Zones: User's Manual for Release 3.0." National Exposure Research LaboratoryUSEPA, Athens, GA; AQUA TERRA Consultants, Mountain View, CA; and Waterborne Environmental, Inc., Leesburg, VA. p. 5-12.