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 120 

TEXT SEARCHABLE DOCUMENT
TABLE 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 . Conceptual Model ..................................................................................................................... 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 

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(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/Reproductive . Effects ....................................................................................... 55 

b . Terrestrial Invertebrates ................................................................................................... 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 at Risk ...................................................................................... 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 . Ecological Effects 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 (CAS No. 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 spectrum tetramic 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 concentrates andlor 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, cucurbit vegetables, fruiting vegetables plus 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 (including airblast), or through chemigation (sprinkler-type irrigation systems only), and 

are recommended to be tank-mixed with a spray adjuvant (or additive) that enhances the systemic nature of 

spirotetramat by aiding infiltration, penetration, and translocation of or within leaves and root systems. 

There are two possible stereoisomers of 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-en01 is 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 conservatively assumed 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). 

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 of biological organization. 

Page 4 of 120 
Page 5 of 120 

to All Freshwater and 

Estuarinelmarine Plants quotients (RQs) for all aquatic animals and plants are below the 

Agency's screening levels of concern (LOCs). Although actual chronic 

risk estimates were not derived for estuarinelmarine organisms, acute 

toxicity estimates appear to be roughly equivalent in sensitivity to those 

for freshwater organisms, and the low chronic risk to freshwater fish 

Chronic risk estimates for birds are based upon a non-definitive 

NOAEC of <28.8 mglkg-diet (effects were seen at all tested 

concentrations) and all RQs are greater than the reported values. 

Therefore, until a discrete NOAEC 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. Although further discussion of this uncertainty is provided in 

Acute and Chronic Risks 

to Mammals 

Risks to Upland and 

Wetland Plants 

Risks to Terrestrial NonTarget Insects 

None 

None 

Acute and 

Chronic 

the "Risk Description" section of the risk assessment, it is important to 

note that even based on the current NOAEC, 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 on broadleaf plantsJsmal1 insects 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 of the 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 

conservative exposure scenario considered in 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 invertebrates to pesticides for screening 

level assessments for non-endangered species. However, risks to nontarget listed and non-listed insects cannot be 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 the 
C. 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 is included 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 of brood 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 development while 

displaying low acute toxicity. 

Although EFED has no current way to quantitatively estimate exposure 

and risk to earthworms and soil-dwelling organisms, if one assumes 

that all of the applied spirotetrarnat within 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-dwelling organisms 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 are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, repand 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 

Terrestrial invertebrates 

Terrestrial invertebrates, birds, 

terrestrial amphibians, and reptiles 

~irdk, terrestrial amphibians, and 

reptiles 
I considered eauivalent. I 

D. Exposure Characterization 

Spirotetramat may degrade1 transform through various routes, which include hydrolysis in alkaline media, 

photolysis in natural water and biodegradation in aerobic and anaerobic environments, both in soil and 

aquatic media (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 = 14.4 Phoenix, AZ days) appear to be routes of transformation of 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-en01 is oxidized at the benzylic carbon position into spirotetramatketohydroxy. Spirotetramat-en01 may further yield other minor transformation products. Several of the 

metabolism studies follow a similar transformation pathway. (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-en01 is also generally short lived in aerobic soil environments (DTSo <1 day), but could be 

more persistent to 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 

applied radioactivity (AR)]. These results are generally supported by an aerobic outdoors study in which 

spirotetramat degraded quickly (DTSOY s of 1.1-2.9 days in two soils). 

One likely route of exposure to spirotetramat to aquatic environments will be from the contamination of 

surface waters 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-target by spray drift. Spirotetramat is not 

generally expected to be an important leacher (despite its moderately mobile classification), for its low 

persistence. Similar routes 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-en01 and spirotetramatketohydroxy may be of concern in soils and water due to their high concentrations in 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 

141-693 days 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 support this 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 of binding, 

spirotetramat residues 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 contaminate groundwater. It appears that spirotetramat and or 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 application mixture. 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: methoxycyclohexylamino-carboxylic acid and methoxy-cyclohexanone (1 1.3-17.5% of AR). In contrast, under 

aqueous photolysis condition, in sterile buffered solution at a pH of 5, spirotetramat degraded with a DT50 

of 14.4 Phoenix, AZ days. In buffered solution, spirotetramat is 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 soil photodegradation study was found to have certain deficiencies that 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& = 1.067 rnLIg; mean hc = 65.3 mL/goc), mobility 

was classified as moderately mobile, mobile and mobile to highly mobile, respectively (according to the 

FA0 mobility 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 confirm the laboratory findings of rapid degradation1 

dissipation of spirotetramat @T50'~ of 0.3-1.0 days, in the 0-45 cm soil layer). The major transformation 

products found in the field are likely to be spirotetramat-en01 and spirotetramat-ketohydroxy. They were 

not present at significant amounts below the 0-1 5-cm soil layer. Half-dissipation times for the combined 

residues of spirotetramat-en01 and spirotetramat-ketohydroxy ranged 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-en01 and spirotetramat-ketohydroxy are not likely to bioaccumulate/ 

bioconcentrate because their Gw's are 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 spirotetramat below. 

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 drawing the 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 scheme for earthworms, spirotetramat appears to be of relatively 

low toxicity to earthworms as there were no observed toxic effects up to the highest concentration tested in 

the sub-chronic 14-day study. Only a 14-day study with 4-methoxy-cyclohexanone and an 8-week study 

with spirotetramat-en01 demonstrated any toxic effects to earthworms. 

Although spirotetramat can be classified as practically non-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 abundance were detected. Spirotetramat also 

had a wide range in magnitude of acute effects on other various non-target terrestrial arthropods. 

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. 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 dry weight, 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, slightly to 

highly toxic to freshwater invertebrates, and moderately to highly toxic to estuarinelmarine invertebrates on 

an acute basis. Although there is no toxicity classification scheme for aquatic vascular and non-vascular 

plants, toxic effects were demonstrated in the available studies with duckweed (yield and growth) and 

algae (biomass and growth rate). 

There is the also the potential for chronic andlor reproductive effects resulting from spirotetramat use as 

demonstrated in studies with birds (e.g., Jmean hatchling bodyweight, J # of 14-day survivors, 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 parental males), 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 essentially complete. 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 soil photodegradation study, provides only limited supplemental information and is uncertain 

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 sterile natural 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-en01 and spirotetramatketohydroxy). The amount of such degradates and the rate of soil photodegradation on soil are uncertain. 

In order to obtain an adequate description of the role of soil photodegradation on the environmental fate of 

spirotetramat, and the presence and quantities of degradation1 transformation 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 classification is unknown. The registrant 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, respectively in 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 spirotetramat in aerobic soil metabolism studies. 

In the "hot spots" application method, utilized in the laboratory studies, spirotetramat was applied in 

acetonitrile at 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 conducted with spirotetramat-en01 (with higher solubility, 

the test substance was 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 uncertainty with respect to the possible presence in the environment of the aqueous photolysates 

from the study conducted in sterile buffer solution, compared to those photolysates 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 study lasting 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-en01 did not appear to depend on the soil pH's in aerobic soil 

metabolism studies conducted 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 of pH's was 6.1-6.5 for three EU soils and it was 5.4 for the FL SL (as measured in 

CaC12 solution); 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 available Koc's for spirotetramat-en01 were estimated fiom a series of soil column leaching studies 

instead of the conventional batch equilibrium study. There is uncertainty in those values since the 

chemical is labile under various metabolism conditions; furthermore, it was found that spirotetramat-en01 is 

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 single year, exposure estimates and risk to aquatic and terrestrial organisms could be 

significantly underestimated. Examples of crops that have multiple seasons where 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 

should be 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 submitted but were not formally reviewed by AGES prior to this assessment. However, 

a cursory review of the data suggests that all formulations are of roughly 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 cursory EFED review, or they had been reviewed 

previously by 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 Studv with the Mallard Duck (Anas platvrh.vnchos): 

A definitive NOAEC based on the available avian reproduction studies has not been established for 

spirotetramat; adverse reproductive effects were observed at the lowest tested concentration in the available 

avian reproduction study with mallards. The most sensitive NOAEC value of <28.8 mgkg-diet with 

which chronic avian RQs were calculated, was based on a statistically significant -6.58% reduction in 

mean hatchling bodyweight. Although no additional statistically significant effects were observed at this 

test level, large reductions in other frank effects that were observed at 28.8 mgkg-diet included reductions 

in # of 14-day survivors (J22%), # of viable 14-day embryos (J la%), # of live embryos (J la%), and # of 

eggs hatched (J22%). 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 

Page 11 of 120 
effects, it is reasonable to assume they are significant biologically.Therefore, the ability of this study to 

statistically detect what could be considered to be biologically relevant endpoints appears to be limited, and 

an additional study is needed to reduce uncertainty by establishing a definitive NOAEC capable of 

capturing biologically relevant reductions in endpoints. 

OPPTS Guideline 850.3040; Field Testing for Pollinators 

Despite that 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 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 of brood 

development, and early brood termination as a result of spirotetramat use. This information, coupled with 

the fact that two other chemicals representing the ketoenole class of compounds (spiromesifen and 

spirodiclofen) have also demonstrated the potential for chronic effects on bee broods and development 

while displaying low acute toxicity, suggests that the mode of action of these compounds (i.e., inhibition of 

lipid biosynthesis) may adversely affect bee broods and development. Although a study has 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 could be statistically determined. Therefore, it is recommended that a study design be 

developed in collaboration with the Environmental Fate and Effects Division. In the interim, the following 

protective pollinator 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 "Directions for Use" section of this label for specific crop application 

instructions that minimize risk to honey bee larvae." 

OPPTS Guideline 850.1075; Freshwater Fish Toxicity with Fathead Minnows (Pimephales oromelas): 

Under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional 

pesticide products, it is stated that if the species used 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 

species tested in the early-life stage study must 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 Studv with a Passerine Species: 

Under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional 

pesticide products, it is stated that data are required on one passerine species in addition to either one 

waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor 

uses. Currently there are no acute oral toxicity studies with 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 invertebrate life-cvcle (EstuarineMarine): 

Chronic toxicity data for estuarinelmarine invertebrates 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 environmental concentration 

(EEC) in water is 1 0.01 of the acute ECS0. However, these toxicity estimates are.based on toxicity to the 

Page 12 of 120 
eastern oyster, yet the chronic life-cycle study with estuarinelmarine invertebrates is conducted with 

mysids. Based on mysid toxicity data, these requirements would not be met. In addition, acute toxicity 

studies suggest that freshwater and estuarinelmarine organisms are equally sensitive to spirotetramat, and 

currently there are no risk concerns for freshwater fish and invertebrates. Therefore, although the 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. 

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, evaluates the nature of the problem, and provides a plan for analyzing the data and 

characterizing the risk (EPA, 1998). 

A. Nature of Regulatory Action 

Under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FERA), the registrant, 

Bayer Cropscience is seeking the Section 3 registration for the new active ingredient, Spirotetramat, for 

use as an insecticide. This section of the report summarizes the 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 

Spirotetramat is 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 spirotetramat may 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 

subsequently degrades 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. 

Spirotetramat total residues (spirotetramat + transformation products spirotetramat-en01 + spirotetramatketohydroxy + non-extracted residues) are relatively more persistent than the parent or the metabolites 

alone (tl/,'s of 16 1-204 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-en01 and spirotetrarnat-ketohydroxy are considered mobile 

(respective mean 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 study performed with two soils and in all four 

terrestrial field dissipation studies. 

UVNis Absorption 

Spectra 

Although both spirotetramat-en01 and 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 concentrations in the laboratory studies (spirotetramat-enol) and 

their persistence relative to 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 

Peak Maxima Molar Absorptivitv burity 99.2%) 

(nm) (1 000 cm2/ moo 

211 22.0 x 103 

2 76 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 concentrates or 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 chemical may 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 (except kiwifruit), pome fruits (Crop Group 1 I), stone fruits (Crop Group 12), tree nuts (Crop 

Group 14 plus Pistachio), hops, Christmas trees, cucurbit vegetables (Crop Group 9), hiting vegetables 

(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 approaches the analysis for adverse effects through the 

use of broad 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 surrogate for aquatic phase amphibians), 

Freshwater invertebrates (including sediment-dwelling species), 

EstuarineMarine Fish 

EstuarineMarine Invertebrates 

Algae and vascular aquatic plants 

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. Toxicological data generated horn 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 submitted by 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 identified through 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 characteristics of the affected communities. 

Table 11.2 provides a summary of the taxonomic groups and the surrogate species tested to help 

understand potential acute ecological effects of pesticides to these non-target taxonomic groups. In 

addition, the table provides a preliminary overview of the potential acute toxicity of spirotetramat by 

providing the acute toxicity classifications. Acute toxicity classifications are based on the scheme outlined 

in Appendix I. 

Page 15 of 120 

Bobwhite quail (Colinus virginianus) 

Mammals 

Insects 

Freshwater fish2 

Laboratory rat (Rattus nowegicus) 

Honey bee (Apis mellz~era L.) 

Bluegill sunfish (Lepomis macrochirus) 

Rainbow trout (Oncorhynchus mykiss) 

Carp (Cyprinus carpio) 

Practically non-toxic 

Practically non-toxic 

Moderately toxic 
a. 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 acute toxicity data for the degradates. Overall, while the toxicity of the 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 earthworms to 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-en01 and 4-methoxycyclohexanone on rainbow trout (for en01 only; 

practically non-toxic), zebra fish (for methoxycyclohexanone only; practically non-toxic), water fleas 

(practically non-toxic for both), midges (slightly toxic for enol, practically non-toxic for methoxycyclohexanone), green algae, and duckweed (enol only).- For spirotetramat-ketohydroxy and 4- 

Page 16 of 120 

Birds represent surrogates for terrestrial-phase amphibians and reptiles. 

2 Freshwater fish may be surrogates for aquatic-phase amphibians. 

Four species of two families of monocots, of which one is corn; six species of at least four dicot families,of which 

one is soybeans. 

Brassicaceae), soybean (Glycine ma.), sunflower 

(Helianthus annuus L., Asteraceae), sugarbeet 

(Beta vulgaris, Chenopodiaceae), tomato 

(Lycopersicon esculentum, Solanaceae) 

Duckweed (Lemna gibba) 

Green algae (Pseudokirchneriella subcapitata) 

Freshwater diatom (Navicular pellicullosa) 

Blue-green algae (AnabaenaJlos-aqua) 

Marine diatom (Skeletonema costatum) 

Honey bee (Apis mellifera) 

Predatory mite (Typhlodromus pyri) 

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 demonstrating that 

both can be classified as practically non-toxic to these organisms. 

For terrestrial organisms, 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 practically non-toxic to these organisms. Lastly, toxicity data for 

earthworms using spirotetramat-ketohydroxy, spirotetramat-enol, and 4-methoxycyclohexanone, and 

gamasid mites using spirotetramat-enol, suggest the overall toxicity to these organisms is low. 

b. Formulations 

In addition to acute toxicity data for the parent and degradates, there were also acute toxicity data available 

on BY1 08830 150 OD and Movento 240 SC in some instances. Only the 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 generally the 

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 studies were found to contain the most sensitive 

endpoint available for a given taxonomic group based on a cursory EFED review, or they had been 

reviewed previously by AGES, their details are not discussed within the body of this assessment. 

Specifically, for the formulations BY1 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 formulations that 

demonstrate they can be classified as practically non-toxic. 

For bees, there are acute toxicity data on both of the formulations that demonstrate the 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 honey bees, 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 study with earthworms (4-8 weeks), one with gamasid mites (28 days), and a 

testicularlsperm toxicity study with 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 testicularlsperm toxicity 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 study with fathead minnows, decreased emergence and developmental rate in the 28-day 

Page 17 of 120 
spiked-water study with midges, and decreased reproduction and weight and length of parents in the lifecycle study with water fleas were all chronic/reproductive effects 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 development of 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 

cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian 

habitats and other uncultivated 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. Assessment Endpoints 

Assessment endpoints represent 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 Section II.P.2, the "Analysis Plan", for further discussion.) 

E. Conceptual Model 

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

concentrations. An exposure pathway is the mews by 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 conceptual model 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 conceptual model 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-enol and spirotetramat-ketohydroxy), when used in 

accordance with the label, results in potential adverse effects upon the survival, growth, and 

reproduction of non-target terrestrial and aquatic organisms. Given the persistence and mobility 

of spirotetrarnat and/ or its residues, there is a likelihood of exposure 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 spectrum tetramic 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 concentrations are sufficiently elevated as a result of proposed 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 transport pathways, exposure media, exposure points, biological 

receptor types, and attribute changes. 

Although both spirotetrarnat-en01 and 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 of release 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 spray drift 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 of primary concern in this assessment for terrestrial 

animal receptors. 

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 octanoVwater partitioning 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 

inhalation LCso (>4.183 mg/L), and the low dermal acute toxicity of the parent in the rat (LDS0 >2000 

mgkg-bw), all suggest that these routes of exposure are not 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 of pesticide associated with 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 highly mobile and 

could be potentially transported 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) contaminated with spray driR and/ or runoff 

from treated areas. Food chain exposures are not considered to be significant for this pesticide because 

spirotetramat has a low l-octanoV water partition coefficient. 

Lastly, potential points of exposure for terrestrial or semi-aquatic plant receptors may include direct 

contact via 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 

cumulative effects to plants resulting fi-om combined 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 Conceptual Model for Screening-Level Risk Assessment of 

Spirotetramat Applied to Agricultural Fields 

I Spirotetramat total residues (spirotetramat, spirotetramat-enol, and spirotetramatketohvdroxv) aoolied as aroundlaerial sorav to an 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:::, &Am* FoliagelSoil Upland ----------- Groundwater ; 

I FoliageISoil 

Exposure 

Point 

4 + + 

Ingestion Direct contact/ Direct contact1 GilV Integument 

I Root Uptake Root Uptake Uptake 

Terrestrial Vertebrates 

Receptors & Invertebrates 

Birds, Small Mammals, 

Reptiles, Terrestrial 

Attribute Individual Animals 

Changes Reduced survival 

Reduced growth 

Reduced reproductior 

Amphibians 

Plant Po~ulation 

Reduced survival invertebrates 

Reduced SUNN~~ 

Reduced growth 

Reduced reproduction 

Bioaccumulation 

*Dotted lines are used to signify exposure pathways that are not expected to 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 closely methods 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 dividing the 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 corresponding RQs, 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 

respective measures of exposure and effects for spirotetramat are listed in Table 11.3. 

For agricultural uses, exposure concentrations for aquatic ecosystems assessments were estimated based on 

EFED's Tier 2 aquatic model PRZMIEXAMS. A graphical user interface (PE5), developed by 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 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 

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 and IDpotatoes. 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 directly from empirically determined observations of pesticide residues on various terrestrial food 

items. The Kenaga nomogram, as modified by Fletcher et al., (Kenaga and Hoerger, 1972; Fletcher et al., 

1994) is used to relate pesticide application rates to residues on terrestrial food items. The surface residue 

concentration (ppm) is estimated by multiplying the application rate (pounds active ingredient per acre) by 

a value specific to each food item. For numerous applications for a given use, the exposure model 

incorporates a first-order decay rate dependent on the foliar dissipation half-life of the chemical. The 

conceptual approach 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. 

Exposure to terrestrial plants is estimated using the TerrPlant (v1.2.2) Tier 1 screening model. 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 does not 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 

Spirotetramat is a new pesticide against chewing insects. It may be applied a minimum of 2-3 times at the 

maximum application rate of 0.08-0.1 6 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 interval between applications is 7-30 days, and the 

'~~50 = Lethal dose to 50% of the test population; NOAEC =No observed adverse effect concentration; LOAEC = Lowest observed adverse effect 

concentration; = Lethal concentration to 50% of the test population; EC5dEC25 = Effect concentration to 50Yd25% of the test population. 

2~irds represent surrogates for amphibians (terrestrial phase) and reptiles. 

Freshwater fish may be surrogates for amphibians (aquatic phase). 

One in 10-year return tkequency. 

Four species of two families of monocots - one is corn, six species of at least four dicot families, of which one is soybeans. 

Page 23 of 120 
pre-harvest interval (PHI) ranges from 1-7 days. A summary table 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) (mcludmg Amencan 

bunch grape, muscadme grape 

and Wera grape) 

Pome Fruit (Crop Group 11, 

mcludmg apple, crabapple, 

loquat, mayhaw, pear, oriental 

pear, qmce) 

Stone Fruit (Crop Group 12, 

mcludmg apncot, sweet and 

tart cherry, nectarine, peach, 

plum-vanous hds, plumcot 

and fiesh and dried prune) 

Tree Nuts (Crop Group 14 

plus p~tacluo, mcludmg 

almond, beechnut, Brazll nut, 

butternut, cashew, chestnut, 

chquapm, filbert-hazelnut, 

luckory nut, macadarma nutbush 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 

NIA 
Page 25 of 120 

Cucurbit Vegetables [Crop 

Group 9, includmg chayote, 

Chinese waxgourd-Chinese 

preserving melon, citron 

melon, cucumber, gherkin, 

gourd-various kinds, 

Momordica spp. -includes 

various kinds, muskmelon 

(various kinds like cantaloupe, 

casaba, Crenshaw melon, 

melon, honeydew melon, 

Persian melon, pineapple 

melon, snake melon, and 

others), pumpkin, squash 

(includes summer type squash 

like scallop squash zucchini 

and others, and winter type 

squash like acorn squash 

calabaza and others), and 

watermelon (includes hybrids)] 

Fruiting Vegetables (Crop 

Group 8 plus okra including 

eggplant, groundclieny, okra, 

pepinos, pepper-various kinds, 

tomatill0 and tomato) 

Leafy Vegetables (Crop 

Group 4 including amaranthvarious kinds, arugularoquette, cardoon, celery, 

celtuce, chervil Chinese 

celery, chrysanthemum, corn 

salad, garden cress, cressvarious kinds, dandelion, sorrel 

dock, endive, Florence fennel, 

lettuce-head and leaf, orach, 

parsley, garden and winter 

purslane, radicchio-red 

chicory, rhubarb, spinachvarious kinds, Swiss chard) 

Brassica (Cole) Leafy 

Vegetables (Crop Group 5 

including broccoli raab, 

Brussels sprouts, cabbage, 

cauliflower, cavalo broccolo, 

Chinese broccoli, Chinese 

cabbage, Chinese mustard 

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 

1 
arracacha, arrowroot, 

artichoke-Chinese and 

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, side roll, 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 application rate per year may be higher 

than the maximum seasonal application rate. 

The registrant recommends that spirotetramat may be applied alone or tank-mixed with another Group 23 

insecticide (that is, with mode of action of lipid biosynthesis inhibition 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 labels recommend that spirotetramat's products should be tank-mixed with a spray adjuvant/ additive 

that may have spreading and penetrating properties to increase the 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, applications prior to petal-fall on pome hits, stone 

fruits and tree nut crops are not recommended. 

For runoff management, it is indicated that the product may contaminate water 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 surface water 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 applications when 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 

accordance with,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 should be avoided. 3) Avoid spraying during conditions of low 

humidity and/ or high temperature (may increase the evaporation rate of spray droplets). 4) Do not apply 

when winds are greater than 15 mph and avoid gusty and windless conditions. 5) Avoid applications when 

wind direction is toward an aquatic area (can reduce risk exposure to 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 adversely modify 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 summarizes physicall chemical and environmental fate/ 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: Carbonic acid, cis-3-(2,5-dimethylpheny1)-8- 

methoxy-2- oxo-l-azaspiro[4.5]dec-3-en-4-yl ethyl 

ester 

Page 27 of 120 
HLC at 20°C and pH 7, estimated from VP 

[pH 4,7,9; (20 and 25 "C)] Major metabolite - spirotetramat-enol. 

olutim and natural water. 

DTgo for enol= 0.17,0.07,0.53 and 0.06 

Respective DT90 for ketohydroxy- 55.6, 

13.9, 16.9 and 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 120 
Aerobic Aquatic Metabolism *Respective spirotetramat DT90's = 3.52 

**Respective spirotetramat-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 120 
photolysis in sterile buffered 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 degradates most of which have the basic backbone structure 

of spirotetramat. Spirotetramat-en01 is 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 confm the 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-ketohydroxy dissipating much more slowly. 

Given the moderate to high solubility of spirotetramat, spirotetramat-en01 and spirotetramat-ketohydroxy, 

and their relatively low level of binding (relatively low 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 shortly after 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-target by 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 events both via dissolution or bound to the soils (high levels of non-extracted residues were 

observed in most laboratory studies). 

b. General 

Spirotetramat has a moderate solubility in 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 solubility in 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) indicates that 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-octanoll water 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 -octanoV water partition 

coefficient is low (20 at pH 7). These relatively high solubilities in water, coupled with the low octanoll 

water partition coefficients suggest that these transformation products have a low tendency to 

bioconcentratel bioaccumulate and do not partition highly with organic matter. 

c. Degradation 

Hydrolysis is relevant for the overall degradation1 dissipation of spirotetramat in aquatic systems, 

especially in neutral to alkaline conditions. The hydrolysis behavior of spirotetramat depends on the 

temperature and pH. The rate of reaction increased with increasing temperature and pH. At 25OC, the 

experimental half-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. Spirotetrarnat photolyzes with 

Page 30 of 120 
hydrolysis-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 correspond to 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 10 days). 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-methyl carbonate (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 spirotetramat from the environment. 

The soil photodegradation study available on spirotetramat was found to have certain deficiencies and 

definite conclusions on the rate of soil photodegradation could not be derived from it. However, some 

useful information on the identity of the degradates in the study may be obtained from it. The following 

degradates were identified (34.8%): spirotetramat-enol, spirotetramat-ketohydroxy, methoxycyclohexanone 

and dimethylbenzoic acid. Methoxycyclohexanone and dimethylbenzoic acid were observed only in the 

irradiated samples. 

d. Metabolism and Transformation Products 

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-en01 also degraded relatively quickly, with DT507s of <l day, in three soils from 

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

In the course of the spirotetramat-en01 degradation study, spirotetramat-en01 showed a biphasic kinetic 

behavior with >80% of AR degraded by day 1 posttreatment and slower degradation from 1 to 1 19 days 

after treatment or DAT (from 10.7 - 17.2% of the applied radioactivity or 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 study conducted 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 conducted with spirotetramat and 10.9- 

34.9% by 60 days in the study conducted with spirotetramat-en01 (four soils in both cases). Volatile 

organics were 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 1 to 3 DAT, with no decrease thereafter. In the study conducted on 

spirotetramat-enol, using a slightly alkaline extraction procedure, non-extracted residues increased to reach 

levels of -40-60% of AR by 1 DAT, with no significant decrease thereafter. Fractionation of the nonextracted residues showed a heterogeneous composition, with a high portion of hlvic acids in both studies. 

In an outdoor metabolism study spirotetramat degraded with calculated half dissipation times (DTS0's) of 

1.2 and 2.9 days. Spirotetramat-en01 was a maximum of 7.8%. The degradates spirotetramat-glyoxylic 

amide and dimethyl-benzoic acid were observed besides the aerobic soil metabolites. The latter two 

compounds were also observed in the supplemental photodegradation on 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. Spirotetramat was mostly associated with 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-ketohydroxy was a maximum of 50.8% at study termination. DTS03s for 

spirotetramat-en01 were derived from the study results (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. Mineralization was 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). Mineralization was 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 spirotetramat is provided in Table 111.4. The structures 

of all the transformation products of spirotetramat are 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-en01 and 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-en01 occurs to yield spirotetramat-desmethylen01 and subsequently spirotetrarnat-0x0-en01 (minor products). Furthermore, oxidative spirotetramat-en01 

dimerization may occur to yield spirotetramat-en01 dirner 1 and spirotetrarnat-en01 dimer 2. The 

degradation products in most soil and water1 sediment studies were 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 metabolites mentioned above, dimethyl benzoic acid, 

spirotetramat-glyoxylic amide and methoxy cyclohexanone were observed in the soil photodegradation 

study. 

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. 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 120 
order 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-en01 degraded 

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 during the adsorption phase. 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 leachate fractions, spirotetramat-en01 was 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-ketohydroxy is 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), KF values 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), KF values 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 exposure to spirotetramat to surface water environments will be from spray drift. Due to 

their low persistence in aerobic soils, spirotetramat and spirotetramat-en01 generally should be 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 shortly after 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-en01 are not expected to 

be important leachers (despite their mobility classification). It is noted, however, that spirotetramat-en01 is 

persistent in anaerobic environments. Spirotetramat-ketohydroxy was 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-dissipation times @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 stability of spirotetramat-enol, which degraded to spirotetramat-ketohydroxy during storage, 

accurate individual quantification of these metabolites is not possible. Instead, the combined residues of 

spirotetramat-en01 and spirotetramat-ketohydroxy were calculated. Those residues presented calculated 

DT50'~ of4.6-3 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 0-1 5 

cm soil layer, except for detections in the 15-30 cm soil layer at the Florida site; the chemicals observed 

above the LOQ in 15-30 cm soil layer were spirotetramat-en01 and 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-en01 and spirotetramat-ketohydroxy their 

Kow are also low: 2.1 and 20, respectively, pointing towards a low tendency to 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-amide 

\ Oxidation 

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 

Uncertainties and issues were discussed in Section I.F.l, a brief description follows. 

There is uncertainty about the role of soil photodegradation on the fate of spirotetramat and, 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. This part 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-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 of pH'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 environment is uncertain, compared 

to the presence of aqueous photolysates in 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-en01 dimers 1 and 

2, at up to 5.0 and 3.6% of AR, respectively in the aerobic soil metabolism study. It appears that their 

presence may be due to the called "hot spots" application method that was utilized in the laboratory 

studies, where spirotetramat was 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-en01 were 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-en01 is 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-en01 and spirotetramat-ketohydroxy), the non-extracted residues were added as if they were 

persistent compounds. 

Page 36 of 120 
Aerobic outdoor: 

Anaerobic soil: 

Aerobic outdoor: 25.3 (1 4 d) 

Dimethylpheny1)-3- Anaerobic soil: 

azaspiro[4.5]decan2. Measures of ~~uatic' Exposure 

a. Aquatic Exposure Modeling 

For agricultural uses, exposure concentrations for aquatic ecosystems assessments were 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 appropriate PRZM 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 

loadings to ground 6r surface water. This basic file constitutes the 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 surface water, 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 

Mississippi pond). 

Tables 111.5 and 111.6 summarize the input parameters for spirotetramat. Additional background on the 

models PRZM and EXAMS and the model output files are provided in the Appendix B. The estimated 

exposure concentrations are summarized in 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 continental U.S. were selected. The PA tomatoes and ID 

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

Group 8 plus okra), leafy vegetables (Crop Group 4), brassica (cole) leafy vegetables (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 interval between 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 interval between applications. 

There are no usage data because spirotetramat is a new chemical. It is unknown if these rates will be 

representative of 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 

application intervals, 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 applications in 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. Applications were 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 application rates. 

For spirotetramat, the average I(d was a better descriptor of the 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. 13.1 days 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 run was 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 application was modeled (NC apples, with the highest seasonal 

application rate and the most conservative application method). For the total residues, the average li& 

value (from the 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 obtained by adding the values of the 

concentrations of the parent, spirotetramat-enol, spirotetramat-ketohydroxy and non-extracted residues, and 

calculating the 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-en01 was found to be stable to 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 + nonextracted residues. The water solubility of spirotetramat-ketohydroxy was considered the 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 

Minimum Number of Applications 

Allowed at the Maximum 

Application Rate 

Minimum Interval between 

Applications (days) 

CAM (Chemical application 

method) 

IPSCND (Flag indicating the 

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 1 day 

NY grapes 7 days 

NC apples 7 days 

MI cherries 7 days 

CA almond 7 days 

OR Xmas trees N/A 

PA tomatoes 1 day 

ID potato 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 

Estimated from metadata 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 foliar based on crop 

canopy 

1, pesticide remaining on foliage is 

converted to surface application to 
Page 40 of 120 

DEPI = Incorporation Depth (cm) 

Kd (mug) 

Aerobic Soil Metabolism (days) 

Method of Application 

Buffer Zone (ft.) 

Application Efficiency (hction) 

Spray Drift (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 average Kn value, as per EKD 

guidance on input parameters for 

PRZMIEXAMS dated 2/28/02. The 

Kd value represents better the 

mobility of spirotetramat (relative 

standard deviation is smaller). 

Represents the 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) (DFOP best fit kinetics). 

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 

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 

10X the actual solubility as per 

EFED guidance on input 

parameters for PRZMEXAMS. 

Represents the 90' percentile of the 

upper confidence bound 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 

associated with using a single value 

(SF0 kinetics). 

EFED guidance On 

parameters for PRZM/EXAMS 

dated 2/28/02 (SF0 kinetics). 

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, Decay rate on foliage 

PLVKRT, Volatilization rate from 

foliage 

UPTKF, Uptake factor 

Write Benthic Pore Water 

Concentrations? 

Page 41 of 120 

Chemical Name 

Crop Names 

Application Rate 

Day of Application (day-month)/ 

pre-harvest interval 

Minimum Number of Applications 

Mowed at the Maximum 

Application Rate 

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 for pond scenario, as 

opposed to index reservoir. 

--- 

WED guidance on input 

parameters for PRZMEXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PRZh4EXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PRZWEXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PRZMIEXAMS 

dated 2/28/02 

For information only 

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 application rate 

Ib a.i./A: 

NC apples 0.12 and 0.14 x 2 

Estimated from metadata file and 

proposed labels. 

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- 
Page 42 of 120 

Aerobic Soil Metabolism (days) 

Method of Application 

Buffer Zone (ft.) 

Application Efficiency (fraction) 

Spray Drift (fraction) 

Solubility in 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 

OECD Monograph 

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). 

Represents the 90& percentile of the 

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 loglinear parameters) (ttn = 203.82 

days, t1,2 = 169.02 days, tl~z = 

161i16 days, tin= 203.82 days; 

mean = 184.455 days; std. dev. 

22.58984 days). 

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) 

EFED guidance on input 

parameters for PRZMIEXAMS 

dated 2/28/02. 

EFED guidance on input 

parameters for PRZMiEXAMS 

dated 2/28/02 

10X the actual solubility of 

spirotetramat-ketohydroxy, the 

more stable and the latter of the 

three species, as per EFED 

guidance on input parameters for 

PRz,M/EXAMS. 

For the parent + en01 + 

ketohydroxy, represents the 90" 

pmentile of the upper confidence 

bound on the mean of two half-life 

values 385.00; 693.00, 141.43, 

256.67 days; std. dev = 237.794 
There 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 multiplied by 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, Volatilization rate from 

foliage 

WTKF, Uptake factor 

Write Benthic 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 

OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

--- 

--- 

--- 

--- 

--- 

--- 

--- 

-- 

Assumed to be the same than for 

the parent, due to similar structures. 

Assumed to be the same than for 

the parent, due to similar structures. 

Default for the standard pond 

scenario, as opposed to index 

reservoir. 

--- 

EFED guidance on input 

parameters for PRZMIEXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PI1ZMIEXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PRZhUEXAMS 

dated 2/28/02 

EFED guidance on input 

parameters for PRZMIEXAMS 

dated 2/28/02 

For information only 
(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 relatively narrow window considering the 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 

0.41 31 7 

CA almonds ground 

0.341 31 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 applications were simulated. For those applications, a 

clear pattern was observed, with substantial decreases in 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 

0.00825 
I I 

Q chosen representative scenario for spray applications of spirotetramat to agricultud crops. Application 

rate in lb a.i./A and interval between 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 assumptions that the total 

residues are stable to 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 obtained by 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 spirotetramat only (1 1.4 vs. 0.573 ppb). The 21-day EEC for the total 

residues was 72 times higher (1 1.1 vs. 0.154 ppb) 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 spirotetramat is 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 of pesticide 

concentrations in wildlife food items focuses on quantifying possible dietary ingestion of residues on 

vegetative matter and insects. The EFED terrestrial exposure model 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 surface residue concentration 

(ppm) is estimated by multiplying the application rate (pounds active ingredient per acre) by a value 

specific to each food item (termed the 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 still present 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 calculating the 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 calculating the 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 acceptable by the Office of Pesticide Programs' (OPP) Health Effects 

Division (HED), and the other study on wheat and soybeans was a non-guideline study that 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 criteria by which magnitude of 

residue studies are deemed acceptable for use in ecological risk assessments by 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 represent the one tail upper 90% confidence limit of the 

mean half-lives for the parent and total residue approaches were 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 effective in the environment against target pest 

species for periods of time longer than might be suggested by these estimated half-lives. Whether the 

discrepancy between 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 of persistence of the 

compound remains unclear. Subsequently, how well the patterns of dissipation observed on the agricultural 

crops reflects actual foliar dissipation expected in the environment on 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 spirotetramat are 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 hit scenario based on total residues approach) can be found 

in Appendix F. 

Page 46 of 120 
om 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 directly with dietary toxicity data or 

converted to an oral dose, as is done for small mammals. For mammals, the residue concentration is 

converted to daily oral dose based on the fraction of body weight consumed daily as estimated through 

mammalian allometric relationships. The screening level risk assessment for spirotetramat uses upperbound predicted residues as the measure of exposure. Summaries of the predicted uppa-bound and mean 

residues of spirotetramat that 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 15.26 ppm 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 120 
18.57 ppm for mean residues. Concentrations were 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 

cucurbit vegetable usage scenario. 

b. Exposure Modeling: Non-target Invertebrates 

Currently, the Agency does not quantitatively evaluate the potential exposure of terrestrial invertebrates to 

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) screening model. 

TerrPlant estimates potential exposure from a single application using default assumptions for runoff and 

spray drift (Table lII.10). For runoff plus drift, TerrPlant incorporates two 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 adjacent to 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 10 times 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 inputs to the model 

(besides a drift haction of either 0.01 or 0.05) include the maximum single application rate, incorporation 

depth, and runoff fraction. While the application rate and incorporation depth are label-specified, the 

entered runoff fkaction is selected based on the solubility of the compound of interest, and can be 0.01, 

0.02, or 0.05 if the solubility of the compound is 40 ppm, 10 to 100 ppm, or >I00 ppm, respectively. See 

Appendix G for additional information. 

Specifically for spirotetramat, estimates were generated by assuming that it was not ground incorporated, 

and that 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). Lastly, since plant toxicity data are not 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 solubility of the parent is 29.9 mg/L, the 

degradates of concern are more soluble (solubility= 2700 mg/L and 228 mg/L for spirotetramat-en01 and 

spirotetramat-ketohydroxy, respectively), and the overall solubility of the total residues of concern was 

assumed to be greater than 100 mg/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 seedling emergence studies. For RQs for non-listed and listed species of monocots and dicots 

exposed solely via spray drift, the EECs for spray drift deposition only (without a runoff exposure 

component) are directly compared with the most sensitive measure of effect from either the vegetative 

vigor or seedling emergence studies. 

Page 48 of 120 
As 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 demonstrates that 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 = application rate x 0.05; for ground applications the EEC = application rate 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 characterization is 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 completed by 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 reviewed by 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 cursory EFED review, or they had been reviewed previously by AGES, their details are not 

discussed within the body of this assessment. 

Toxicity testing reported in this section does not represent all species of birds, 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. Estuarinelmarine testing 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 highly toxic" 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-body weight; 

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 appears to be of relatively low toxicity to earthworms as there were no observed toxic effects 

up to the highest concentration tested in the sub-chronic 14-day study (NOAEC= 1000 mgikg-dry weight 

soil). Only a 14-day study with 4-methoxy-cyclohexanone (J body weight; NOAEC=125 mgikg-dry weight 

soil) and an 8-week study with spirotetramat-en01 (J reproduction; NOAEC=32 mag-dry weight soil) 

demonstrated any toxic effects to earthworms. 

Although spirotetramat can be classified as practically non-toxic to honey bees (LDS0 range = 91.7 to 162 

pg a.i./bee for both 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 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 study with 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 application rate of 0.16 lb a.i./A. However, there were some significant 

adverse effects observed in the available vegetative vigor studies including: reduced shoot dry weight of 

shattercane (EC25, =0-06 lb 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= 1.41 to 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 estuarinelrnarine invertebrates (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 demonstrated in 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=0.36 mg a.i./L, NOAEC=0.124 mg a.i./L). 

Avian reproduction studies demonstrate that 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-day embryos (4 1 8%), # of live embryos (4 1 8%), and # of eggs hatched (422%). 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, it is reasonable to assume 

they are significant biologically. 

The 2-generation rat reproduction study demonstrated the potential for parental systemic, reproductive, and 

offspring effects to mammals, and established a NOAEC of 1000 mgkg-diet (LOAEC of 6000 mgkgdiet). Observed effects at the LOAEC included: decreased body weight and body weight during 

lactation in both F1 and F2 generations; abnormal sperm cells and decreased reproductive performance in 

the F1 males; decreased body weight (F1 males and females), weight gain (P males, F1 males and females), 

and food consumption during lactation (P- and F1-generation females); and kidney histopathology and 

decreased kidney weights (FI males and females). 

In the available aquatic studies, observed chronic/reproductive effects included: decreased survival in 

the early-life stage study with fathead minnows (NOAEC=0.534 mg a.i./L, LOAEC=l. 16 mg a.i./L); 

decreased emergence (NOAEC=O. 1 mg a.i./L, LOAEC=0.2 mg a.i./L).and developmental rate 

(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 mortality in adults (NOAEC=2 mg a.i./L, 

LOAEC=5 mg a.i./L) in the life-cycle study with water fleas. 

Page 51 of 120 
I I I Bobwhite quail LC5o >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= 1000 mglkg-diet (70.7 mg/kg- body weight) 

lkshwater fish 

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 

Terrestrial plants 

Reproduction and growth 

- 

Water flea NOAEC= 2.0 mg a.i./L 

Survival 

Reproduction and growth 

Survival 

Reproduction and 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 

Sheepshead minnow 96-hour LC50= 1.96 mg 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. 16 lb a.i./A 

Survival and growth: Non-listed 

P Survival and growth: Listed 

Duckweed (vascular) 96-hour EC5O= 4.49 mg a.i./L 

Skeletonema costatum (non-vascular) EC50=0.36 mg a.i./L 

Duckweed (vascular) 96-hour NOAEC = 1.54 mg a.i./L 

Skeletonema costatum (non-vascular) 96-hour NOAEC=O. 124 

mg a.i./L I I I ' Measurement endpoint was based on a -6.58% reduction in mean hatchling bodyweight at the lowest test level. 

'A conservative estimate of dietary acute toxicity was generated using the existing rat oral LDSo and assuming a conservative ingestion rate of 100 percent of the 

body weight. The resulting estimated dietary acute toxicity endpoint is 22000 m&-diet [(>2000 mgkg-bw)(l kg-bwllkg-diet) = >ZOO0 mgkg-diet]. 

Measurement endpoint was based on a study conducted with a Spirotetramat OD 150. Because a comparison of the available data suggests that the toxicity of 

the technical gradeactive ingredient (TGAI) and formulated spirotetramat is roughly equivalent (overlapping confidence intervals), the most sensitive 

measurement endpoint was chosen regardless of whether it was based on the TGAI or a formulated product. 

There were some effects on canola in one vegetative vigor study. A slightly higher, but definitive ECzs=0.17 lb a.i.1A was generated, and so was a lower 

NOAEC = 0.06 lb a.i.1A. However, the more conservative ECzs (N. 16 lb a.i.1A) and the associated NOAEC were selected for use. 

Page 52 of 120 
2. Aquatic Toxicity 

a. Acute Effects 

Chironomus riparius 

Page 53 of 120 
b. Chronic/Reproductive Effects 

3. Terrestrial Toxicity 

a. Terrestrial Vertebrates 

1. Acute Effects 

Page 54 of 120 
ii. Chronic/Reproductive Effects 

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 

Decreased body 

weight, and 

2 mortalities at the 

highest dose 

No treatment-related 

mortalities 

Decreased body 

weight gain and feed 

consumption 

No treatment-related 

mortalities 

Decreased body 

weight gain and feed 

cmumption 

Barflcnecht, 

2003 

Bdecht, 

2004 

Stoughton, 

2005 
NOAEC = 264 mgikg-diet 

b. Terrestrial Invertebrates 

Page 56 of 120 
Page 57 of 120 

adults and pupae. 

No adverse effect. 

Apis mellifra 

(Honey bee) 

Apis rnellifra 

(Honey bee) 

Apis mellifea 

(Honey bee) 

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 

lkg until 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 

crop before 

colony set-up at 

0.064 lb a.i./A + 

2 applications at 

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 

OD1 50 

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 termination rate in two of 

three colonies. 

Increased adult mortality. 

No adverse effect. 

Termination of 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 

Significant mortality (>51%), was 

observed for up 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= 1000 mgkgdw soil 

EC~O~LCS~ 1000 mgkg-dw soil 

NOAEC= 1000 mgkgdw soil 

EC50/LC59 1000 mgkg-dw soil 

NOAEC= 1000 mgkg-dw soil 

EC~O/LC~O> 1000 mgkg-dw soil 

NOAEC= 1000 mgkg-dw soil 

ECswLCso> 1000 mgkg-dw soil 

NOAEC= 1000 mgkg-dw soil 

ECsO/LC5+ 1000 mglkg-dw soil 

NOAEC= 125 mgkg-dw soil 

EC5olLC50> 1000 mgkg-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>lOOO mglkg-dw soil 

NOAEC= 3 16 mgkg-dw soil 

EC5~LC5+1000 mgkg-dw soil 

NOAEC= 1000 mgkgdw soil 

7 days 

days 

Exposure until 

pupation 

Exposure until 

pupation 

14 days 

14 days 

14 days 

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 

clried residues 

(acute and aged 

on treated apple 

leaves 

Contact with 

dried residues on 

treated bean 

leaves 

Contact with 

dried residues 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) 

Lolium perenne (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 dry weight 156.6% at 0.26 lb a.i./A 

Cucumber dry weight 141.3% at 0.26 lb a.i./A 

Cucumber survival 15% at 0.26 lb a.i./A 

Canola dry weight 183.3% at 0.26 lb a.i./A 

Soybean dry weight 140.2% at 0.26 lb a.i./A 

Sunflower dry weight 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 

Ryegrass dry weight: 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, ECz5 N.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=0.19 lb 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 

Shattercane shoot dry weight: NOAEC=0.02 lb a.i./A, EC25=0.06 lb 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~ 

2006b 
Avena saliva (Oats) 

Lolium perenne (Ryegrass) 

Allium cepa (Onion) 

No adverse effects 225% at 0.16 Ib a.i./A 

Cucumis sativus (Cucumber) 

Brassica napus (Canola) 

Glycine max (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 evaluate the 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 generate RQs that are then compared to the Agency's 

levels of concern (LOCs) to determine the 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 spirotetramat to 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 Exposure Modeling" 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 

applications at 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 estuarinelmarine water-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 are presented in Table IV.3. 

fish (LC50 = 1960 pg a.i.L). 

e parent spirotetramat only as well as for total residues (i.e., residues for the 

OAEC = 534 pg a.i./L). 

S are reported for the parent spirotetramat only as well as for total residues (i.e., 

Page 61 of 120 

I Parent only I 0.573 0.0016 0.0001 0.0046 0.0004 
2. Risks to Non-Target Terrestrial Organisms 

As discussed previously in the "Terrestrial Exposure Assessment" portion of the chapter, terrestrial 

exposure modeling 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 considered the 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 

single proposed application rate, the maximum number of applications, and the minimum application 

interval. However, only the most pertinent results of these analyses conducted with 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 chronic toxicity value (dose-based equivalent was calculated by study authors based on food 

consumption during the study). All dietary-based RQs are calculated using EECs expressed in terms of 

residue concentration for the various forage categories, and toxicity values (LC50 or NOAEC) are 

expressed in units of dietary concentration. Dose-based RQs are calculated using a body weight-adjusted 

toxicity value (LD5O or 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 aerial application scenario, based on 3 applications at a rate of 0.4 lb a.i./A/season and a 7-day interval, generated the highest peak 

EECs. 

Toxicity values are based on studies with duckweed (Lemna gibba) 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 are used to derive 

RQs for non-endangered species while NOAEC values are used to determine RQs for endangered species. 

" 24-hour peak EEC values generated from PRZMIEXAMS are reported for the parent spirotetramat only 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 

exposure basis. Therefore, this risk assessment presents only acute avian RQs based on upper-bound 

EECs for total residues for the most conservative modeled 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 Exposure Assessment7') 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. 

0.03 17 0.0919 

Page 62 of 120 

0.0074 
It must be noted that chronic risk estimates for birds are based upon a non-definitive NOAEC 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 

additional chronic LOC exceedances beyond those that have been definitively identified below. Until a 

discrete NOAEC 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, for the sake of RQ 

presentation below, those RQs that are currently exceeding the chronic LOC even based on the nondefinitive NOAEC (<28.8 mgkg-diet) have been identified separately from those that are not currently 

exceeding but have the potential to until a definitive NOAEC is established. Further discussion of this 

uncertainty is provided 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 

available for spirotetramat, dietary-based chronic RQs for avian species (Table IV.5) feeding on short 

grass meet or exceed the chronic risk LOC (1) for all but two of the evaluated crop use scenarios for both 

the parent-only (RQ range = >0.82 to >1 SO) 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 broadleaf plants/small insects under the pome hit scenario when using the total residue 

approach, currently exceeds 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. 

EECS 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. 

' The most sensitive LQo and LC50 values for birds were non-defmitive as they were determined to be greater than the highest tested levels in the 

available toxicity studies. Therefore, because all acute RQs are based on non-definitive toxicity values, they represent conservative estimates of risk and 

are expressed with a '<' sign. 

dAU acute RQs are below the acute LQCs far non listed species (0.5), restricted use (0.2), and listed species (0.1). 

Dose-based 

Dietary-based 

Page 63 of 120 

"The maximum exposure scenario was the pome fit scenario, with a maximum single application rate 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 only mammalian RQs based on upperbound EECs for total residues for the most conservative modeled scenario (Table IV.6); the pome hit 

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 mammals (1 5g 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 are based 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 discrete NOAEC 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 exceeding the chronic LOC (id 

bold) have been identified separately hm those that are not currently exceeding but have the potential to until a definitive NOAEC is. established. 

b~he chronic RQ meets or exceeds the chronic risk LOC (1) even based on the nonldeftnitive NOAEC 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 

>0.06 
that was based on a highly conservative estimate of 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 1000 mgkg-diet 

(NOAEL = 70.7 mgkg bwlday), the highest chronic mammalian RQ for the modeled upper-bound 

exposure scenario was 0.32 (Table IV.6). Because this RQ value calculated under the upper-bound 

exposure scenario is less than the Agency's chronic LOC (I), the chronic RQs 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 quantitatively evaluate 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 hit scenario, with a maximum single application rate of 0.14 lb a.i./A, a 7day application 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 existing rat oral LD50and assuming a conservative ingestion rate of 100 

percent of the body weight. The resulting estimated dietary acute toxicity endpoint is >2000 m&-diet [(>2000 mgkg-bw)(l kg-bwllkg-diet) = 

22000 mgkg-diet]. 

*The most sensitive LD50 and LCs0 values for mammals were non-definitive as they were determined to be greater than the highest tested levels in 

the available toxicity studies. Therefore, because all acute RQs are based on non-definitive toxicity values, they represent 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). 

'AU chronic 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 screening model 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 TerrPlant was modeled and presented in this assessment. Specifically, estimates 

were generated by assuming that spirotetramat was 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 solubility was greater than 100 mg/L (solubility fraction = 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 

126 mg/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 

0.05 
A 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 demonstrates that 

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 exceeded the 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 assessment is 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 spirotetramat in accordance with label directions is expected to result in direct 

adverse effects on survival, growth, and reproduction of both 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 exceeding the 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 exposure modeling, 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 conservative modeling scenario possible for spirotetramat. Specifically, it was assumed that spirotetramat 

was 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 

ktion = 0.05), and that the solubility is greater than 100 mg/L (solubility hction=0.05). Refer to "Exposure Characterization" section of the 

assessment for additional information. 

The most sensitive EC25 value from seedling emergence studies used to derive RQs for non-listed plants in upland and wetland areas was >0.16 lb 

a.i./A for both monocots and dicots. 

' The most sensitive NOAEC value hm seedling emergence studies used to derive RQs for listed plants in upland and wetland areas was 0.16 lb 

a.i./A for both monocots and dicots. 

* The most sensitive ECz5 values from vegetative vigor studies used to derive RQs 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 sensitive NOAEC values from vegetative vigor 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 spectrum tetrarnic 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), UltorTM SC (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, hiting vegetables 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 spirotetramat is direct 

deposition of off-target spray drift. The potential sources and mechanisms of release as a spray include 

conventional ground sprayers, airblast equipment, rotary wing aircrafts, or sprinkler-type chemigation 

methods. Once present in these systems, volatilization of spirotetramat from 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 terrestrial environment, the major route(s) of dissipation for spirotetramat are degradation to 

spirotetramat-en01 and spirotetramat-ketohydroxy (the two 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-en01 is then firther oxidized at the benzylic 

carbon in aerobic environments to yield the other major metabolite, spirotetramat-ketohydroxy (maximum 

24.0% in the aerobic soil metabolism study). 

In addition to spray drift, given their moderate to high solubility, relatively low level of binding, and low 

tendency to 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 

dictated by numerous varying factors including topography, irrigation, and regional meteorological 

patterns, spirotetramat and spirotetramat-en01 generally should only be available for runoff or leaching in 

substantial amounts 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 according to aerobic soil metabolism studies @T50116.7 days), 

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 spirotetramat include 

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 associated with the aqueous phase and rapidly degraded with 

a calculated DTS0 of <lday in the total system. The major transformation products in the aerobic aquatic 

metabolism study, spirotetramat-en01 and spirotetramat-ketohydroxy, were much more persistent than the 

Page 67 of 120 
parent under the same conditions (DT5O = 37.9-59.0 days for spirotetramat-en01 and 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 developing the half-lives for the total residues of concern, all, 

spirotetramat, spirotetramat-enol, spirotetramat-ketohydroxy and the non-extracted residues were 

considered toguether. The aerobic soil half-lives ranged from 161-204 days (mean 184 days); while the 

aerobic aquatic metabolism half-lives ranged hom 141-693 days (mean 364 days). These values indicate 

high persistence of the total residues of spirotetramat. 

Although both spirotetramat-en01 and 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 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 degradates by 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) appear to be close in terms of 

relative toxicity. However, even assuming the 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 

chronic RQ. 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 surrounding the 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.. .wherever the 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 concentrations in any of the aquatic studies 

were based on centrifuged supernatant, there is uncertainty regarding the amount of spirotetramat 

bioavailable to the test organisms and all estimates of toxicity for aquatic organisms. However, 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 

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 exposure concentrations in the environment. Although the label stated that 

spirotetramat can be applied via 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, exposure estimates 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 single year. 

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 ordinarily in this instance 

acute-to-chronic ratios 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 acute toxicity endpoint for fathead minnows. However, by examining the 

predicted 60-day (0.0108 mg a.i./L) and 21-day (0.01 11 mg a.i./L) EECs for total residues and the most 

sensitive chronic toxicity endpoints available for freshwater fish (fathead minnow 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 approximately 49 and 180 times more sensitive than fathead minnow and water fleas on 

a chronic basis, respectively, in order to trigger exceedances of 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 approximately 9485 and 12987 times 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 chronic basis. 

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 species used 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 study must 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 above to re-evaluate chronic risk estimates for freshwater fish. 

For invertebrates, a 28-day study with midges has been submitted; however, the design of the study 

deviates significantly from what would be required under part 158 of Title 40 in the U.S. Code of Federal 

Regulations. Specifically, while the study was conducted in the presence of sediment, the water column 

was spiked once, equilibrium between the water column, pore water, and sediment was not achieved, and 

test concentrations dropped rapidly. In addition, concentrations were 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 compound that is 

expected to degrade rapidly in water. While initial measured concentrations in 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 concentrations in pore 

water were less than the LOQ at all time intervals in all test levels except the 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 exposure in 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 spirotetramat and its major degradates expected to 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 (Chivonomus riparius), 

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=0.66 mg 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 conservative yet reasonable screening level 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-om the study based on initial nominal concentrations in overlying water 

(NOAEC=O. 1 mg a.i./L based on reduced emergence) is most directly comparable to 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 study with 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 any reproductive 

effects), the resultant toxicity value would be compared to the 21 -day parent-only EEC in the water column 

(0.000154 mg a.i./L) and would have to be -650 times higher than the current NOAEC in order to trigger 

any chronic concerns for this taxonomic group. Despite the uncertainties associated with the toxicity 

estimates, it appears that 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 invertebrates 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 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 study with estuarinelrnarine invertebrates is conducted with mysids. Based on mysid 

toxicity data, these requirements would not be met. In addition, acute toxicity studies suggest that 

fi-eshwater and estuarinelmarine organisms are equally sensitive to spirotetramat, and currently there are no 

risk concerns for freshwater fish and invertebrates. Therefore, although the 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 120 
a. Non-Target Birds and Mammals 

Based on the best available information kd terrestrial exposure modeling 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, fall below the Agency's LOCs. 

Currently there is insufficient evidence for mammals and birds to discount the 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/sperm toxicity study that was conducted with spirotetramat-en01 and reviewed by 

the Office of Pesticide Program'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-en01 is 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 evaluate the relative toxicity 

of the degradates to the parent for terrestrial vertebrates. 

Despite the 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 of risk values is 

influenced, the magnitude of risk remains unchanged and results of both the parent-only and total-residue 

approach yield the same interpretation of risk (the same LOC exceedances) in all but one instance 

(specified below). 

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 average body 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 (maximum theoretical RQ= <0.17 for 

the pome hit scenario; potential exceedance of the endangered species LOC (0.1)). However, the fact 

that the highest RQ estimated using this approach is non-definitive and is less than the reported value (with 

no observed mortalities), taken in conjunction with an LDS0 of >2000 mgkg-bw established for quail in the 

only acute oral toxicity study available, suggests that the overall potential for acute mortality of birds 

resulting fiom spirotetramat use is likely low. 

The other uncertainty is that although risk of acute mortality to avian species appears to be low, there is 

some indication of 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 

statistically significant sub-lethal effects were observed in an acute study (NOAEC<344 mglkg-diet; 

significantly decreased body weight at all treatment levels in the sub-acute dietary toxicity study) was 

compared to dietary-based EECs. 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 concentrations of spirotetramat (lowest 

NOAEC <344 mgkg-diet vs. lowest LCS0>5000 mg/kg-diet ), it is unclear how these effects would impact 

the birds7 ability to 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 were just 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, suggests that 

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 exceedances beyond those that have been definitively identified 

(Table IV.5). Until a discrete NOAEC is established for chronic/reproductive effects 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-defmtive NOAEC, 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 >1 SO) and total residues 

approaches (RQ range = >0.93 to >1.82), as does the RQ for birds feeding on broadleaf plants/small 

insects under the pome hit scenario 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-conservative mean 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 should be noted. First, all 

RQs are greater than the reported value so potential chronic LOC exceedances cannot be precluded until a 

definitive NOAEC 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. (1 994) 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 3-1 3% of the upper-end residue estimates were 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 (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) is >1.82 times higher than the most sensitive NOAEC. 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 sensitive NOAEC are less than the chronic 

LOCs for all birds. However, since there is uncertainty with respect to the estimated magnitude of RQs 

(all RQs are greater than the reported values), the definitive rate reduction needed to lower all RQs below 

the LOCs cannot be identified until a defmitive NOAEC is established for chronic/reproductive effects to 

Page 72 of 120 
birds. 

A closer look at the most sensitive NOAEC 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 

hatchling bodyweight at the lowest test level. Although no other statistically significant effects were 

observed at the 28.8 mg/kg-diet test level, other affected endpoints with a NOAEC of 28.8 mgkg-diet 

(LOAEC = 78.8 mglkg-diet ) include # of hatchlings of live 3-week embryos (520%), # of 14-day old 

survivors of eggs set (517%), # of 14-day survivors 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 

sensitive NOAEC for the study is truly less than 28.8 mgkg-diet and whether a request for an additional 

avian reproduction study is 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 study for 

hatchling bodyweight was calculated, and it corresponded to roughly a 5.78% reduction from the control 

group. Given that there is less than a one percent difference between 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-day embryos (J18%), # of live embryos (51 8%), 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 significant biologically, and may warrant the request 

for an additional avian reproduction study. In addition, at the 78.8 mgkg-diet treatment level, there were 

effect levels up to 3 1 % for some endpoints that were not detected as being statistically significant using 

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 ability of 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/reproductive effects 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 

estimate to 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 

appeared to 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 corresponded to 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-day old 

survivors; 28.8 mgkg-diet ). Previously, based on the NOAEC of 28.8 mglkg-diet, only RQs 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, exceeded the 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 broadleaf plants/small insects for both the parent-only and 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/large insects 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 broadleaf plants/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-only residues. 

For the previously discussed 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 closely with the statistically significant experimental LOAEC (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-day old 

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 of birds that rely on a high reproductive 

rate for population sustainability may be the most susceptible to the effects of spirotetramat. 

Page 74 of 120 
In addition to the uncertainty regarding the reproductive NOAEC for birds, there are three major 

uncertainties associated with the predicted EECs for terrestrial vertebrates. First, as for aquatic EECs, 

terrestrial EECs were estimated by assuming that spirotetramat was applied at a maximum of 3 times per 

year, despite that the proposed labels allow for up to 3 applications per 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 exploratory manner to conservatively estimate upper-bound total and 

parent-only EECs for all the exposure scenarios considered in this assessment by assuming that 

spirotetramat could be 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 

application rate. Based on this analysis, although the EECs and RQs increased slightly in magnitude, there 

were still no acute or chronic risk concerns for mammals, or acute risk concerns for birds. In addition, no 

additional RQs 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 

terrestrial vertebrates, 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 

run for 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 application rate. 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 spirotetramat on 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 conservative as 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 application rate estimated by dividing the maximum seasonal application rate 

by the maximum number of applications would result in an underestimate of predicted peak residues. 

However, for characterization purposes only, an application rate estimated by dividing the maximum 

seasonal application rate by the maximum number of applications for each of the affected exposure 

scenarios was 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, climbing fruits, pome fruit, and stone hits dropped 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 approaches by chronic LOC (1) exceedances. 

0.10 to 0.20 

0.07 to 0.13 

Page 75 of 120 

a Upper-bound residues calculated using T-REX model (T-REX, Version 1.3.1, dated December 7,2006). 

5, 10, and 15% effect levels correspond to concentxations of 8.3, 16.5, and 24.8 mgkg-diet , as estimated using The 

Benchmark Dose 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 

1.08 to 2.1 1 
Lastly, 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 spirotetramat in 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 applications may be underestimated. However, as 

mentioned previously, spirotetramat is to be applied as a preventative treatment only when sufficient leaf 

tissues are present for uptake and translocation to occur; thus, the effectiveness of this compound in 

protecting agricultural crops appears to be largely dependent upon efficient and accurate application to 

leaves, and the amount of the compound in the soil versus what is initially in/on plants is expected to be 

low. In addition, given the expected short half-life idon plants based on the magnitude of residue 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 evaluate the potential exposure and risk of terrestrial 

invertebrates to pesticides for screening level assessments for non-endangered species. Risk estimates for 

terrestrial invertebrates would be complicated by the complex and varied life histories of these types of 

organisms, and a lack of data on exposure pathways. The risk characterization for 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 contact toxicity 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./bee and 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 mortality in adults and pupae, massive 

perturbation of brood development, and early brood termination were detected. 

In addition, a semi-field brood test was conducted with a representative formulation (l3YI08330 100 OD) 

in a representative model crop, oil-seed spring rape (Brassica napus). In this study, three pre-flowering 

applications at 0.064 lb a.i./A followed by two applications at 0.086 lb a.i./A were made to a blooming 

flowering bee-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 study was conducted with BY108330 150 OD and the honey bee (Apis mellifera L.) in the 

Valencia region 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 120 
times during flowering and foraging activity of the bees at an application rate 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, as part of its agricultural development (AD) and stewardship program, 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 submitted under FIFRA 

6(a)(2). The data collected under these experimental conditions may exaggerate exposure and are not 

necessarily representative of populations of bees 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 demonstrated that formulated spirotetramat has 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 exclusively on flowering crops, specifically after application to 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 spirotetramat is not classified as highly acutely toxic to honey bees 

based on laboratory acute contact and oral toxicity tests, results of brood 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 conditions by 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 overall bee 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 approximately one 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 employed total application rates were approximately half the maximum proposed seasonal 

application rate. 

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 spirotetramat is 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 (spiromesifen and 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-target Arthro~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 application rate of spirotetramat in a 

season is 0.40 lb a.i./A. Comparing this 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 demonstrated no 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 120 
Formulated 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 study with parasitoid wasp adults (Aphidius rhopalosiphi) exposed to dried residues on 

treated barley plants, to an LDSo= 0.0003 lb a.UA for a 7-day acute contact toxicity test with predatory mite 

protonymphs (Typhlodromuspyri) exposed to 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 study with predatory mite protonymphs 

(Typhlodromus pyri) 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 (>5 1 %), indicating a 

lingering effect post application. 

The only field study that was conducted was in France and was aimed at evaluating the effects of 

spirotetramat on acarine mite fauna, including predatory mites, 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-day studies with spirotetramat and spirotetramat-ketohydroxy, no treatment related 

effects were observed up to the highest tested concentration (EC5&CS0 and NOAEC values were >I000 

mglkg-dry weight soil). In a 14-day study with 4-methoxy-cyclohexanone, a NOAEC was established at 

125 mgkg-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 established based on a decrease in the mean number of 

juveniles. No other effects were seen any of the studies. 

Only one study was conducted with another soil-dwelling organism, other than earthworms. This study was 

a 34-day reproduction study with 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 of up to 3 growing 

seasons per year, the annual application rate can be estimated to be 1.20 lb a.i./year, or -0.0134 mg 

a.i./cm2. Assuming that spirotetramat is 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 

spirotetramat possible 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 indicates that soil exposure concentrations are still more than 

Page 78 of 120 
3 times lower than the most sensitive NOAEC 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 studies to EECs estimated based on the most conservative exposure scenario possible for 

spirotetramat using TerrPlant (v1.2.2), demonstrates that 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 characterization of risk to plants for spirotetramat 

revolves around its systemic nature and the potential uptake via root systems as an additional route 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 exposure threshold 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 EC25 values from the available vegetative vigor study. This approach demonstrates that while all RQs 

for dicots would still be 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 species was 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 conservative EC25 (>0.16 lb a.i./A) and the associated NOAEC >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 

question the 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 screening program to determine whether certain substances 

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

effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may 

designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory 

Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the 

program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA 

also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in 

wildlife. For pesticide chemicals, EPA will use FIFRA, to the extent that effects in wildlife may help 

Page 79 of 120 
determine whether a substance may have an effect in humans, and the FFDCA authority to require the 

wildlife evaluations. As the science develops and the resources allow, screening of additional hormone 

systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate 

screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening 

Program have been developed, spirotetramat may be subjected to additional screening and or testing to 

better characterize effects related 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 decreases in # 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 

survivors of 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-day old 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 reproductive parameters. Observed effects in the submitted 

mammalian reproduction study include, but are not limted to, decreased body weight and body weight gain 

during lactation in both F1 and F2 generations, and abnormal sperm cells and decreased reproductive 

performance in the F1 males. 

Results of studies evaluating chronic/reproductive effects to aquatic organisms also show exposure to 

spirotetramat produces adverse effects on reproductive parameters. Adverse effects include, but are not 

limited to, decreased fathead minnow Ery survival, decreased water flea growth and reproduction, and 

decreased midge emergence and development. 

Results of these reproduction studies suggest that spirotetramat could 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 

screening level, the risk assessment considers broadly described taxonomic 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 assumed to be located in a surface water 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 exposure to the pesticide, and that exposures are likely to 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 

species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, 

and no further refinement of the action area is necessary. Furthermore, RQs below the listed species LOCs 

for a given taxonomic group indicate no concern for indirect effects upon listed species that 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 species LOCs for a given taxonomic group, a potential for a 

"may affect" conclusion exists and may be 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 determine the 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 screening level 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 calculations reveal values that meet or exceed the 

listed species LOCs. For those taxa or measurement endpoints for which RQs are not calculated (i.e., 

terrestrial invertebrates) EFED uses any relevant data to make a qualitative assessment of potential 

exposure pathways and risks. An evaluation of risk conclusions for each taxonomic group is presented 

below in Table V.1. Should estimated exposure levels occur in proximity to listed resources, the available 

screening level information suggests a potential concern for direct effects to listed terrestrial non-target 

invertebrate, avian, reptilian, and amphibian species associated with areas where spirotetramat is used. 

Page 81 of 120 
2. Probit Dose Response Relationship 

Terrestrial invertebrates, birds 

Birds, terrestrial amphibians, and 

The Agency uses 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 interpretation is 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 spirotetramat on par with the acute toxicity 

endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the 

dose response relationship available from the toxicity study used to establish the 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 estuarinelmarine invertebrates was from a study with 

eastern oysters, and was not based on mortality or immobilization. Therefore, the mortalitylimmobilization 

data available for mysids was used to perform these analyses for estuarinelmarine invertebrates. 

Mammals 

Aquatic plants 

(vascular and nonvascular) 

Fish, aquatic 

amphibians2 

Aquatic 

Invertebrates 

The individual effects probability 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 are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, reptiliaq 

and amphibian species are considered equivalent. 

Fish are used as a surrogate for 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 

Terrestrial invertebrates 

Terrestrial invertebrates, birds, 

terrestrial amphibians, and reptiles 

Birds, terrestrial amphibians, and 

reptiles 
based 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 are based on available 

information on the 95% confidence interval of the slope. A statement regarding 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 

confidence is 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% confidence intervals), 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) developed by the U.S. EPA, OPP, Environmental Fate and Effects 

Division (June 22,2004) (Table V.2). The model allows for such calculations by entering the mean slope 

estimate (and the 95% confidence bounds of that estimate) as the slope parameter 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 corresponding to 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 mortality was 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 corresponding estimated chance of individual mortality associated with 

the listed species LOC 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 associated with uncertainty in the resulting 

estimates. To explore possible 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 corresponding estimated 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 lo5 and -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 associated with 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 

corresponding estimated 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 associated with uncertainty in the resulting estimates. To 

explore possible 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. 

Although the Agency has assumed a probit dose response relationship in establishing the listed species 

LOCs, the available data for the toxicity study generating RQs 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 acute toxicity studies (both dietary and dose-based) on avian species were unable to establish 

toxicity values (LCSo or LD50). It was demonstrated that the LCSO and LD50 values 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 acute toxic endpoint for birds is -1 in 2.94 x lo5. It is recognized that 

extrapolation of very low probability events is associated with considerable uncertainty in the resulting 

estimates. To explore possible 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 confidence intervals. 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 acute toxicity studies on mammalian species were 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 

response relationship 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 1.66 x l0l3 

(-1 in 3.79 x lo5 and -1 in 2.26 x 
C. Indirect Effects Analysis 

The Agency acknowledges that pesticides have the potential to exert indirect effects upon the listed 

organisms by, for example, perturbing forage or prey availability, altering the extent of nesting habitat, and 

creating gaps in the food chain. In conducting a screen for indirect effects, direct effect LOCs for each 

taxonomic group are used to make inferences concerning the potential for indirect effects upon listed 

species that rely upon non-endangered organisms in these taxonomic groups as resources critical to their 

life cycle. Species specific concerns for spirotetramat indirect effects to listed organisms will require a 

determination of the coincidence of spirotetramat use 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 

Estuarinelmarine invertebrates 

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 exposure to ascertain if a "not likely to adversely affect" determination can be made. 

The degree to which additional analyses are performed is commensurate with the predicted probability of 

adverse effects from the comparison of the dose response information with the EECs. The greater the 

probability that exposures will produce effects on a taxa, the greater the concern for potential indirect 

effects for listed species 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 identified the potential for direct 

effects (risks) to beneficial insects/terrestrial invertebrates 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, consideration is given to the physical 

and biological features (constituent elements) of a critical habitat identified by the U.S Fish and Wildlife 

and National Marine Fisheries Services as essential to the conservation of a listed species and which may 

require special management considerations or protection. The evaluation of impacts for a screening level 
pesticide risk assessment focuses on the biological features that are constituent elements and is 

accomplished using the screening level taxonomic analysis (risk quotients, RQs) and listed species levels 

of concern (LOCs) that are used to evaluate direct and indirect effects to listed organisms. 

The screening level risk assessment has identified potential concerns for indirect effects on listed species 

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 determine whether the action area 

overlaps critical habitat or the occupied range of any listed species. If so, EPA would examine whether the 

pesticide's potential impacts on non-endangered species would affect the listed species indirectly, or 

directly affect a constituent element of the critical habitat. Alternatively, the agencies could determine 

which listed species depend on biological resources, or have constituent elements that fall into the taxa that 

may be directly or indirectly impacted by the pesticide. Then EPA would determine whether use of the 

pesticide overlaps the critical habitat or the occupied range of those listed species. At present, the 

information reviewed by EPA does not permit use of either analytical approach to make a definitive 

identification of species that are potentially impacted indirectly or critical habitats that is potentially 

impacted directly by the use of the pesticide. EPA and the Service(s) are working together to conduct the 

necessary analysis. 

This screening level risk assessment for critical habitat provides a listing of potential biological features 

that, if they are constituent elements of one or more critical habitats, would be of potential concern. These 

correspond to the taxa identified above as being of potential concern for indirect effects and include 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 determine whether sites of pesticide use are geographically 

associated with known locations of listed species. At the screening level, 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 species that are located within counties known to produce the 

crop upon which the pesticide will 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 spirotetramat is 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 endangeredlthreatened species 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 clams to 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 quality to meet FFRA 

requirements. The information will be used by the OPP Endangered Species Protection Program to 

develop recommendations to avoid adverse effects to listed species. 

VI. Literature Cited 

Environmental Fate Studies Discussed in Assessment 

MRID 46904408 

Bayer CropScience AG, 

Report No.: MEF-041169, 

Edition Number: M-256849-02-2 

Date: 07.07.2005, Amended: 05.05.2006 

Bayer CropScience AG, 

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 

Edition Number: 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 CropScience AG, 

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 Cropscience AG, 

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 CropScience AG, 

Report No.: 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 

BCS 
Report No.: MEF-041169, 

Edition Number: M-256849-02-2 

Date: 07.07.2005, Amended: 05.05.2006 

eport No.: 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 CropScience AG, 

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 CropScience AG, 

Report No.: MEF-061199, 

Edition Number: M-277178-01-2 

Date: 31.05.2007 

Non GLP, unpublished 

[Carbonyl-14C] 4-methoxycyclohexanone: Aerobic soil 

degradation in three soils 

Bayer CropScience AG, 

Report No.: MEF-051485, 

Edition Number: M-269022-02-2 

Date: 28.02.2006, Amended: 18.07.2006 

GLF', unpublished 

BYI08330: Anaerobic soil metabolism ' 

Bayer CropScience AG, 

Report No.: MEF-051515, 

Edition Number: M-270739-01-2 

Date: 03.05.2006 

GLP, unpublished 

also filed. KUA 7.1.2 101 

Jn house laboratory validation of an analytical method far 

the determination of BY108330 and its metabolites 

BYI08330-enol, BYI08330-ketohydroxy and BYI08330- 

MA-amide in soil and sediment by LC/MS/MS 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNX012, 

Yes 

Yes 

Yes 

Yes 

Yes 

BCS 

BCS 

BCS 

BCS 

BCS 
Date: 29.08.2006 

Bayer CropScience AG, 

Report No.: MEFNY004, 

Edition Number: M-277191-01-1 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MEFWXO55, 

Edition Number: M-277184-01-1 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

KK4 7.3.1 I051 

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, 

Edition Number: M-277186-01-1 

Date: 05.09.2006 

GLP, unpublished 

Terrestrial field dissipation of BYI08330 in Washington 

soil, 2004 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MEFNY003, 

Edition Number: M-277189-01-1 

Date: 05.09.2006 

GLP, unpublished 

Stability of AE 03 17309 and AE B197555 in soil during 

him storage, USA, 2005 (reported through a maximum 

of 320 days storage) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNXO18, 

Edition Number: M-277371-01-1 

Date: 29.08.2006 

GLP, unpublished 

Independent laboratory validation of method FN-002-SO5- 

02 for the determination of BYI08330 and its metabolites 

BY108330-en04 BYI08330-keto-hydroxy and BYI08330- 

MA-amide in soil and sediment by LSNSIMS 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MR-061037, 

Yes 

Yes 

Yes 

BCS 

BCS 

BCS 
Edition Number: - 

Date: 31.05.2007 

Bayer CropScience AG, 

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 7.4.2 I051 

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, 

Edition Number. M-266755-01-2 

Date: 21.10.2005 

GLP, unpublished 

Adsorpton/desorption of BYI08330-cis-en01 in five 

different soils 

Rheinland-Pfalz AgroScience GmbH, Neustadt, Germany 

Bayer CropScience AG, 

Report No.: IM2000, 

Edition Number: M-267858-01-2 

Date: 05.09.2005 

GLP, unpublished 

[Azaspirodecenyl-3-l4C]BYIO8330-enol: Time-dependent 

sorption in soils 

Bayer CropScience AG, 

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-Pfalz AgroScience GmbH, Neustadt, Germany 

Bayer CropScience AG, 

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 

from five soils 

Battelle UK Ltd.; Ongar; United Kingdom 

Bayer CropScience AG, 

Report No.: CXl041070, 

Edition Number: M-263686-01-2 

Date: 07.09.2005 

GLP, unpublished 

Estimation of the adsorption coefficient (Koc) of BYI 

08330-en01 dimer 1 (ROI 6,14C-labelled) and BY1 

08330-en01 dimer 2 (ROI 7,14C-labelled) on soil using 

high performance liquid chromatography (HPLC) 

Bayer CropScience AG, 

Report No.: MEF-061123, 

Yes 

Yes 

Yes 

Yes 

Yes 

BCS 

BCS 

BCS 

BCS 

BCS 
KIIA 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 I011 MRID 

46904405 

KIIA 7.5 I021 MRID 

46904426 

KIIA7.61011MRID 

46904406 

Babczinski, P. 

Hamme1 K. 

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 CropScience AG, 

Report No.: M-270280-02-2, 

Edition Number: M-270280-02-2 

Date: 24.03.2006, Amended: 22.05.2006 

GLP, unpublished 

Analysis of the sorption behaviour of BYI08330-En01 

using a column leaching experiment 

Bayer CropScience AG, 

Report No.: MEF-071220 

Edition number: -, 

Date: 04.06.2007, 

Non GLP, unpublished 

BYI 08330, Mix-Batch 0~04510003 - Vapour pressure 

Siemens Axiva GmbH & Co. KG, FrankFurt am Main, 

Bayer CropScience AG, 

Report No.: 20040156.02, 

Edition Number: M-066171-01-1 

Date: 26.04.2004 

GLP, unpublished 

also fild KUA 2.3.1 101 

Henry's law constant of BY1 08330(AE 1302943) at pH 7 

and pH 9 

Bayer CropScience GmbH, Fmnkfwt am Main, Germany 

Bayer CropScience AG, 

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 CropScience AG, 

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 CropScience AG, 

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 CropScience AG, 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

\ 

BCS 

BCS 

BCS 

BCS 

BCS 

BCS 

BCS 
Date: 15.1 1.2005 

Report No.: MEF-051262, 

Edition Number: M-266753-01-2 

Date: 15.1 1.2005 

Bayer CropScience AG, 

Report No.: MEF-041080, 

Edition Number: 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 CropScience AG, 

Report No.: MEF-041438, 

Edition Number: M-243787-01-2 

Date: 10.01.2005 

GLP, unpublished 

BY1 08330 - Biodegradation 

Bayer Industry Services, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: 200510077101, 

Edition Number: M-263287-01-1 

Date: 16.11.2005 

GLP, unpublished 

BYI08330: Aerobic aquatic metabolism 

Bayer Cropscience AG, 

Report No.: MEF-0415 11, 

Edition Number: M-269307-01-2 

Date: 29.03.2006 

GLP, unpublished 

Kinetic evaluation of the aerobic aquatic metabolism of 

BM08330, BYI08330-en01 and BYIO8330-ketohydroxy in 

water sediment systems 

Bayer CropScience AG, 

Report No.: MEF-061279, 

Edition Number: M-277415-01-1 

Date: 30.08.2006 

Non GLP, unpublished 

Yes 

Yes 

Yes 

BIS 

BCS 

BCS 
Bayer CropScience AG, 

Report No.: M-261943-01-1, 

Edition Number: M-26194341-1 

Date: 06.12.2005 

Report No.: MEF-041400, 

KlIA 7.10 I021 No 

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 

Edition Number: M-09284041-1 

Date: 14.09.2004 

Non GLP, unpublished 

also filed: KIIA 2.10 101 

Calculation of the chemical lifetime of BY1 08330-en01 in 

the troposphere 

Bayer CropScience AG, 

Report No.: MEF-041401, 

Edition Number: M-09284141-1 

Date: 21.09.2004 

Non GLP, unpublished 

Position Paper: Spirotetramat (BYIO8330) - Fate and 

Behaviour 

Bayer CropScience Deutschland GmbH, Fmnkfwt am 

Main, Germany 

Bayer CropScience AG, 

Report No.: MEF-071299, 

Edition Number: - 

Date: 06.07.2007 

GLP, unpublished 

Water solubility of BY1 08330-en01 (AE 1302944) at pH 5, 

pH 7 and pH 8 (Flask Method) 

Bayer CropScience GmbH, Fmnkfwt am Main, Germany 

Bayer CropScience AG, 

Report No.: PA061035, 

Edition Number: M-27582941-2 

Date: 11.08.2006 

GLP, unpublished 

Partition coefficients 1-Octanoll water of BY1 08330-en01 

(AE 1302944) at pH 5, pH 7 and pH 9 (Shake flask 

method) 

Bayer CropScience Deutschland GmbH, Frankhrt am 

Main, Germany 

Bayer CropScience AG, 

Report No.: PA061036, 

Edition Number: M-27609 1-01 -2 

Date: 17.08.2006 

GLP, unpublished 

BYI 08330-en01 (AE 1302944) - Determination of the 

dissociation constant (spectrophotometric screening 

Yes 

Yes 

Yes 

Yes 

Yes 

BCS 

BCS 

BCS 

BCS 

BCS 
Ecolopical Effects Studies Discussed in this Assessment Or~anized Accordinp to Annex 

PointIReference Number 

ropscience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: AFO61031, 

Edition Number: M-274084-0 1-2 

Date: 05.07.2006 

am Main, Germany 

Bayer CropScience AG, 

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 11 Data and Information 

Edition Number: M-268425-01-2 

Date: 06.09.2005 

GLP, unpublished 

BY1 08330-cis-ketohydroxy partition coefficient 1- 

Octanollwater (HPLC-method) 

Bayer CropScience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: PA05-098, 

Edition Number: 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 CropScience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: AF051098, 

Edition Number: M-263603-01-2 

Date: 16.12.2005 

Non GLP, unpublished 

11.4 8.1.1 2003 

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 CropScience AG, 

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 BCS 
Owner 

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-daydietary LC50 bobwhite 

quail (Colinus virginianus) 

Bayer CropScience AG, 

Report No.: BAR/LC017, 

Edition Number: M-084796-01-2 

Date: 18.08.2004 

GLP 

unpublished 

Technical BYI 08330: A subacute dietary LC50 with 

mallards 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX012, 

EditionNumber: M-274385-01-1 

Date: 03.05.2006 

GLP 

unpublished 

Effect of technical BYI 08330 on northern bobwhite 

reproduction 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFN0220, 

Edition Number: M-277757-01-1 

Date: 21.09.2006 

GLP 

unpublished 

Effect of technical BY1 08330 on mallard reproduction 

Bayer Cropscience, Stilwell, KS, USA 

Bayer CropScience AG, 

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 CropScience AG, 

Report No.: EBFNP033 

Edition Number: M-290165-01-1 

Date: 05.07.2007 

GLP 

unpublished 

Semi-Field Study of the Effects of Dermal and Dietary 

Exposure to BYI 08330 in Mallard Ducks (Anas 

platyrhynchos) 

Bayer CropScience AG, 

Report No.: EBFNP034 

Edition Number: M-290000-0 1-1 

Date: 26.06.2007 

GLP 

unpublished 
Data 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 

BY1 08330 technical: A reproduction study with the 

mallard 

Wildlife International Ltd., Easton, MD, USA 

Bayer CropScience AG, 

Report No.: EBFNP024, 

Edition Number: M-278058-0 1-1 

Date: 29.09.2006 

GLP 

unpublished 

Acute toxicity of BY1 08330 (tech.) to fish 

(Oncorhynchus mykiss) 

Bayer CropScience AG, 

Report No.: DOM 24025, 

Edition Number: M-182649-0 1-2 

Date: 16.12.2004 

GLP 

unpublished 

Acute toxicity of BY1 08330 (tech.) to fish (Cyprinus 

carpio) 

Bayer CropScience AG, 

Report No.: DOM24022, 

Edition Number: M-128667-01-2 

Date: 25.1 1.2004 

GLP 

unpublished 

Acute toxicity of BY1 08330 (tech.) to fish (Lepomis 

macrochirus) 

Bayer CropScience AG, 

Report No.: DOM 24056, 

Edition Number: M-242689-01-2 

Date: 12.01.2005 

GLP 

unpublished 

Acute toxicity of BY1 08330-en01 to fish 

(Oncorhynchus mykiss) 

Baya CropScience AG, 

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 CropScience AG, 

Report No.: 2006/0032/02, 

Edition Number: M-274305-01-1 

Date: 10.07.2006 

GLP 

unpublished 
Data 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-life stage toxicity of BYI 08330 tech to fish 

(Pimephales promelas) 

Bayer CropScience AG, 

ReportNo.: EBFN0305, 

Edition Number: M-260676-01-2 

Date: 16.1 1.2005 

GLP 

unpublished 

Acute toxicity of BYI 08330 (tech.) to the waterflea 

Daphnia magna under static conditions 

Bayer CropScience AG, 

Report No.: DOM 24004, 

Edition Number: M-242683-01-2 

Date: 14.01.2005 

GLP 

unpublished 

Acute toxicity of BYI 08330-en01 to the waterflea 

Daphnia magna in a static laboratory test system -limit 

test 

Bayer CropScience AG, 

Report No.: EBFNM012, 

. Edition Number: M-254487-01-2 

Date: 14.07.2005 

GLP 

unpublished 

4-Methoxycyclohexanone - Acute daphnia toxicity 

Bayer Industry Services, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: 2006/0032101, 

Edition Number: M-274275-01-1 

Date: 10.07.2006 

GLP 

unpublished 

Influence of BY1 08330 (tech.) on development and 

reproductive output of the waterflea Daphnia magna 

in a static renewal laboratory test system 

Bayer CropScience AG, 

Report No.: EBFN0245, 

Edition Number: M-25 1843-01-2 

Date: 13.05.2005 

GLP 

unpublished 

Pseudokirchneriella subcapitata - Growth inhibition 

test with BY1 08330 (tech.) 

Bayer CropScience AG, 

Report No.: DOM 23092, 

Edition Number: 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 (where relevant) 

Published or not 

Toxicity of BY1 08330 to the heshwater diatom 

Navicula pelliculosa 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX008, 

Edition Number: M-252794-0 1-1 

Date: 15.06.2005 

Non GLP 

unpublished 

Toxicity of BYI 08330 to the blue-green alga 

Anabaena Jlos-aquae 

Bayer Cropscience, Stilwell, KS, USA / 

Bayer CropScience AG, 

Report No.: EBFNX007, 

Edition Number: M-264055-0 1-1 

Date: 12.01.2006 

GLP 

unpublished 

Pseudokivchneriella subcapitata - Growth inhibition 

test with BY1 08330-en01 

Bayer CropScience AG, 

Report No.: EBFNMOIO, 

Edition Number: M-252531-01-2 

Date: 06.06.2005 

GLP 

unpublished 

4-Methoxycyclohexanone - Alga growth inhibition test 

Bayer Industry Services, Leverhen, Germany 

Bayer CropScience AG, 

Report No.: 2006/0032/03, 

Edition Number: M-275954-0 1-1 

Date: 28.07.2006 

GLP 

unpublished 

Acute toxicity of BY1 08330 (tech.) to larvae of 

Chironomus riparius in a 48 h water-only study 

Bayer CropScience AG, 

Report No.: EBFNX072, 

Edition Number: M-262632-0 1-2 

Date: 08.12.2005 

GLP 

unpublished 

Acute toxicity of BY1 08330-en01 to larvae of 

Chironomus rigarius in a 48 h water-only study 

Bayer CropScience AG, 

Report No.: EBFNX073, 

Edition Number: 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 

BCS 
Data 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 (where relevant) 

Published or not 

Acute toxicity of BY1 08330-ketohydroxy to larvae of 

Chironomus riparius in a 48 h static laboratory test 

system 

Bayer CropScience AG, 

Report No.: EBFN0347, 

Edition Number: M-263956-01-2 

Date: 16.01.2006 

GLP 

unpublished 

Acute toxicity of 4-Methoxycyclohexanon to Larvae of 

Chironomus riparius in a 48 h static laboratory test 

system (Limit-Test) 

Bayer CropScience AG, 

Report No.: EBFX104, 

Edition Number: M-287218-01-1 

Date: 27.04.2007 

GLP 

unpublished 

Acute toxicity of BYI 08330-cis-methoxycyclohexylamino carboxylic acid to Larvae of 

Chironomus riparius in a 48 h static laboratory test 

system (Limit-Test) 

Bayer CropScience AG, 

Report No.: EBFX105, 

Edition Number: M-287220-01-1 

Date: 27.04.2007 

GLP 

unpublished 

Chironomus riparius 28day chronic toxicity test with 

BYI 08330 (tech.) in a water-sediment system using 

spiked water 

Bayer CropScience AG, 

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-renewal test conditiom 

Bayer CropScience AG, 

Report No.: DOM 24019, 

Edition Number: M-255296-01-2 

Date: 29.07.2005 

GLP 

unpublished 
Annex 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, Report No 

GLP or GEP status (where relevant) 

Published or not 

Lemnu gibba G3: Growth inhibition test with BY1 

08330-en01 under static conditions 

Bayer CropScience AG, 

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 CropScience AG, 

Report No.: 20091035, 

Edition Number: M-08 1227-01-2 

Date: 12.07.2004 

GLP 

unpublished 

Assessment of the side-effects of BY1 08330 OD 100 

on the honey bee (Apzi mellifru L.) in a feeding test 

GAB Biotechnologie GmbH & IFU Umweltanalytik 

GmbH, Niefem-Oeschelbronn, Germany 

Bayer CropScience AG, 

Report No.: 20031 168101-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 

Assessment of the sidseffects of BYI 08330 SC 240 

on the honey bee (Apis mellifea L.) in a feeding test 

GAB GmbH, Niefem-Oeschelbrom, Germany 

Bayer CropScience AG, 

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 

Toxicity to the parasitoid wasp Aphidius rhopalosiphi 

(DeStephani-Perez) (Hymenoptera: Bracconidae) in 

the laboratory; BY1 08330 150 OD; Code: AE 

1302943 00 OD15 A101 

Bayer CropScience AG, 

Report No.: CW051023, 

Edition Number: 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 

BCS 
Owner 

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 (where relevant) 

Published or not 

Toxicity to the predatory mite Typhlodromus pyri 

Scheuten (Acari, Phytoseiidae) in the laboratory, BY1 

08330 150 OD; Code AE 1302943 00 OD15 A101 

Bayer CropScience GmbH, FranlGurt am Main, 

G-Y 

Bayer CropScience AG, 

Report No.: CW051024, 

Edition Number: M-254269-0 1-1 

Date: 12.07.2005 

GLP 

unpublished 

Toxicity to the parasitoid wasp Aphidius rhopalosiphi 

(DeStephani-Perez) (Hymenoptera: Braconidae) using 

an extended laboratory test with BY1 08330 150 OD 

Bayer CropScience GmbH, Fraalurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/071, 

Edition Number: M-2641794 1-1 

Date: 18.01.2006 

GLP 

unpublished 

Toxicity to the predatory mite Typhlodromuspyn' 

SCHEUTEN (Acari, Phytoseiidae) using an extended 

laboratory test BY1 08330 150 OD 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW051030, 

Edition Number: M-25630641-1 

Date: 25.08.2005 

GLP 

unpublished 

Dose-response toxicity (LR50) of BY1 08330 150 OD 

to the green lacewing Chrysoperla carnea (STEPH.) 

under extended laboratory conditions (including foodapplication) 

BioChem agrar, Gerichshain, Germany 

Bayer CropScience AG, 

Report No.: 051048082, 

Edition Number: M-26265041-1 

Date: 14.12.2005 

GLP 

unpublished 
Owner 

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 (where relevant) 

Published or not 

Toxicity to the ladybird Coccinella septempunctata L. 

(Coleoptera, Coccinellidae) using an extended 

laboratory test including exposure to and oral uptake of 

BY1 08330 150 OD 

Bayer CropScience GmbH, FranlGurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW051053, 

Edition Number: 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 CropScience AG, 

Report No.: LKCRG-A-18/03, 

Edition Number: M-104 105-0 1-2 

Date: 07.01.2004 

GLP 

unpublished 

BYI 08330-cis-ketohydroxy: Acute toxicity to 

earthworms (Eiseniafetida) tested in artificial soil 

Bayer CropScience AG, 

Report No.: LKCIRG-A-47105, 

Report includes Trial Nos.: Rg08105 

Edition Number: M-258925-01-2 

Date: 17.10.2005 

GLP, unpublished 

BY1 08330-Enol: Reproduction toxicity to the 

earthworm Eisenida fetida in artificial soil 

ECT Oekotoxikologie GmbH, Floersheim, Germany 

Bayer CropScience AG, 

Report No.: P18RR, 

Edition Number: M-243305-0 1-2 

Date: 19.01.2005 

GLP, unpublished 

Spirotetramat - 4-methoxycyclohexanon: Acute 

toxicity to earthworms (Eisenia fetida) tested in 

artificial soil with 5 percent peat 

Bayer CropScience AG, 

Report No.: LRT-RG-A-98/07, 

Edition Number: M-296072-01-1 

Date: 09.01.2008 

GLP, unpublished 

BY1 08330 tech.: Determination of effects on nitrogen 

transformation in soil 

Bayer CropScience AG, 

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.: Determination of effects on carbon 

transformation in soil 

Bayer CropScience AG, 

Report NO.: LKC-C-30104, 

Edition Number: M-087840-01-1 

Date: 01.09.2004 

GLP, unpublished 

Acute toxicity of BY1 08330 technical to the 

sheepshead minnow (Cyprinodon variegatus) under 

flow-trough conditions 

Bayer Cropscience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNXOOG, 

Edition Number: M-255363-01-1 

Date: 27.07.2005 

GLP 

unpublished 

BY1 08330 - Acute toxicity to mysids (Americamysis 

bahia) under flow-through conditions 

Springborn Smithers Laboratories, Wareham, MA, 

USA 

Bayer CropScience AG, 

Report No.: EBFNXOIO, 

Edition Number: M-270200-01-1 

Date: 06.01.2005 

GLP 

unpublished 

BY1 08330 - Acute toxicity to eastern oysters 

(Crassostvea virginica) under flow-through conditions 

Springborn Smithers Laboratories, Inc., Wareham, 

MA, USA 

Bayer CropScience AG, 

Report No.: EBFNXO 11, 

Edition Number: M-257677-01-1 

Date: 15.06.2005 

GLP 

unpublished 

Toxicity of BY1 08330 technical to the saltwater 

diatom Skeletonema costatum 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNXOO9-1, 

Edition Number: M-271037-02-1 

Date: 23.02.2006, Amended: 16.06.2006 

GLP 

unpublished 
Owner 

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 of BY1 08330 OD 150 in the vegetative vigour 

test (Tier 1) 

Bayer CropScience GmbH, FrankfUrt am Main, 

Germany 

Bayer CropScience AG, 

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 BY1 08330 150 OD 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX016, 

Edition Number: M-276131-01-1 

Date: 09.08.2006 

GLP 

unpublished 

Spirotetramat OD 150: Vegetative vigour test on nontarget terrestrial plants 

BioChem agrar, Gerichshain, Germany 

Bayer CropScience AG, 

Report No.: 061048126, 

Edition Number: M-279698-01-1 

Date: 30.10.2006 

GL? 

unpublished 

Non-target terrestrial plants: an evaluation of the 

effects of BYI 08330 OD 150 in the seedling 

emergence and growth test (Tier 1). 

Bayer CropScience GmbH, Fmnkfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: SE06103, 

Edition Number: 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 CropScience AG, 

Report No.: EBFNX017, 

Edition Number: M-276244-01-1 

Date: 09.08.2006 

GLP 

unpublished 
Annex 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 

BY1 08330-Enol: Effects on survival and reproduction 

of the predaceous mite Hypoaspis aculeife Canestrhi 

(Acari: Laelapidae) in standard soil (LUFA 2.1) 

ECT Oekotoxikologie GmbH, Floersheim, Germany 

Bayer CropScience AG, 

Report No.: P1 lHR, 

Edition Number: M-243307-0 1-1 

Date: 19.01.2005 

GLP 

unpublished 

BYi 08330 - Toxicity to bacteria 

Bayer Industry Services GmbH, Leverkusen, Germany 

Bayer CropScience AG, 

ReportNo.: 1312 N/04 B, 

Edition Number: M-275364-01-1 

Date: 05.10.2004 

GLP 

unpublished 

Residues of Spirotetramat in arthropods after spray 

application in citrus - magnitude and time course of 

residue decline 

RIFCON GmbH, Heidelberg, Germany 

Bayer CropScience AG, 

Report No.: 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 CropScience AG, 

Report No.: 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 following treatment with Spirotetramat 

Bayer CropScience AG, 

Edition Number: not yet fmlised 

Non GLP, unpublished 

Residues of Spirotetmnat in arthropods after spray 

application in citrus - magnitude and time come of 

residue decline 

RIFCON GmbH, Heidelberg, Germany 

Bayer CropScience AG, 

Report No.: 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 

BCS 
Data 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 - Magnitude of the residue idon 

soybeanslwheat, potential wildlife feed items 

Bayer CropScience, Stilweu, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNP002, 

Edition Number: M-2773 15-01-1 

Date: 06.09.2006 

GLP 

unpublished 

Generic field monitoring of birds in potato cultivation 

in northern Germany 

Bayer CropScience AG, 

Report No.: WFC/FS 019, 

Edition Number: M-090336-02-1 

Date: 29.09.2004, Amended: 04.01.2005 

GLP 

unpublished 

Acute toxicity of BY1 08330 OD 150 to fish 

(Oncorhynchus mykiss) under static conditions 

Bayer CropScience GmbH, Monheim, Germany 

Bayer CropScience AG, 

Report No.: EBFNMOO8, 

Edition Number: M-253916-01-2 

Date: 29.06.2005 

GLP, unpublished 

Acute toxicity of BY1 08330 OD 150 to larvae of 

Chironomus riparius in a 48 h static laboratory test 

system 

Bayer CropScience AG, 

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 CropScience AG, 

Report No.: EBFNM006, 

Edition Number: 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-fetal development in rabbit 

Publisher:2005 Wiley-Liss, Inc., 

JodBirth Defects Research (Part B), 

Volume:74, 

Pages:424430, 

Year:2005, 

Report No.: Lit. 8639, 

Edition Number: M-274544-01-1 

Non GLP 

published 

Acute toxicity of BYI 08330 150 OD to the honeybee 

Apis mellifru L. under laboratory conditions 

BioChem agrar, Gerichshrun, Germany 

Bayer CropScience AG, 

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 CropScience AG, 

Report No.: 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 CropScience AG, 

Report No.: 05 1048032, 

Edition Number: M-259122-01-2 

Date: 18.10.2005 

GLP 

unpublished 

Assessment of side effects of Spirotetramat OD 150 

on the honey bee (Apis mellifru L.) in the field 

eurofm-GAB GmbH, ~iefern-~schelbronn, Germany 

Bayer CropScience AG, 

Report No.: 20061 133lS1-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 

BCS 
Data Protection 

Claimed 

Y/N-RiNR 

Yes 

Yes 

Yes 

Yes 

Yes 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

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 CropScience AG, 

Report No.: 20041 14410 1-BZEU, 

Edition Number: M-244490-01-2 

Date: 02.02.2005 

GLP 

unpublished 

Summary of orientating research tunnel aials on 

effects of spirotetramat to honey bees according to 

EPPO 170 

RIFCon GmbH, Leichlingen, Germany 

Bayer CropScience AG, 

Report No.: PA07-174, 

Edition Number: M-2942 16-01-1 

Date: 17.10.2007 

Non GLP, unpublished 

BY1 08330 150 OD; Toxicity to the predatory mite 

Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) 

using an extended laboratory test (under semi-field 

conditions aged residues on apple trees); AE 1302943 

00 OD15 A101 

Bayer CropScience GmbH, Frankfkt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW051028, 

Edition Number: 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 Cropscience AG, 

Report No.: B127AFG, 

Edition Number: M-269107-01-1 

Date: 14.03.2006 

GLP 

unpublished 

Spirotetramat SC 240 g/L + (Inert Ingredient): Effects 

on the Vegetative Vigour of the Non-Target Terrestial 

Plant Shattercane (Tier 2). 

Project Number: Wl071034, EBFNXI 11, 

Ml28861210111. 

Unpublished study prepared by 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 

Completion of This Risk Assessment 

Guideline: 71-2 Avian Dietary Toxicity 

MRID: 46904446 

Stoughton, T. (2006) Technical BYI 08330: A Subacute Dietary LC50 with Mallards. Project Number: 

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 Study with the 

Mallard. Project Number: 1491208, EBFNP024. Unpublished study prepared by Wildlife International, 

Ltd. 162 p. 

MRID: 46904447 

Sabbert, T.; Nuessle, C. (2004) Effect of Technical BYI 08330 on Northern Bobwhite Reproduction. 

Project Number: EBFN0220, M/277757/01/1. Unpublished study prepared by Bayer CropScience LP. 

138 p. 

MRID: 46904448 

Sabbert, T.; Nuessle, C. (2005) Effect of Technical BYI 08330 on Mallard Reproduction. Project 

Number: EBFNX013, MY27779410112. Unpublished study prepared by Bayer Cropscience LP. 154 p. 

Guideline: 72-1 Acute Toxicity to Freshwater Fish 

MRID: 46904438 

Dorgerloh, M. (2004) Acute Toxicity of BYI 08330 (tech.) to Fish (Onchorhynchus mykiss). Project 

Number: DOMY24025, E12801269411, MI1 8264910112. 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: DOMY2405 6, El280/2747/0, MI24268910 112. Unpublished study prepared by Bayer Ag. 53 p. 

MRlD: 46904460 

Nieden, D. (2005) Acute Toxicity of BY1 08330 OD 150 to Fish (Onchorhynchus mykiss) 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: 21 37 1035. Unpublished study prepared by Bayer Cropscience Gmbh. 

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. Project Number: 2003 1 16610 l/BFEU, ELECTRONICICOPY. 
Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 3 1 p. 

MRID: 46904475 

Nieden, D. (2005) Acute Toxicity of BY1 08330-en01 to Fish (Oncorhynchus mykiss). Project Number: 

EBFNMO 13, El2801283417, Pl6841037060. Unpublished study prepared 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-en01 to the Waterflea Daphnia magna in a Static 

Laboratory Test System. Project Number: El320128 1218, EBFNMO 12. Unpublished study prepared by 

Bayer Ag, Institute of Product Info. & Residue Anal. 69 p. 

Guideline: 72-3 Acute Toxicity to EstuarineIMarine Organisms 

MRID: 46904436 

Cafarella, M. (2005) BY1 08330 - Acute Toxicity to Mysids (Americarnysis bahia) Under Flow-Through 

Conditions. Project Number: 1379816170, EBFNXO10, M/270200101/1. Unpublished study prepared by 

, Springborn Smithers Laboratories. 53 p. 

MRID: 46904437 

Cafarella, M. (2005) BYI 08330 - Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under FlowThrough Conditions. Project Number: 13798161 75, EBFNXO 1 1, 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 prepared by Bayer Cropscience LP. 42 p. 

Guideline: 72-4 Fish Early Life StageIAquatic Invertebrate Life 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. Project Number: EBFN0245, 

El3211253713, MI25 184310112. Unpublished study prepared 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 study prepared by Bayer Ag. 
96 p. 

Guideline: 122-1 Seed Germinatiodseedline Emergence and Vegetable Vigor 

MRID: 46904463 

Christ, M.; Lam, C. (2006) Tier I Seedling Emergence Non-Target Plant Study Using 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 II Vegetative Vigor Non-Target Plant Study Using BYI 08330 

150 OD. Project Number: EBFNXO 16. Unpublished study prepared 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 study prepared 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 study prepared by Bayer Ag, 

Institute of Product Info. & Residue Ana. 129 p. 

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 study prepared 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. EBFNXO 16 Tier I and Tier 11 Vegetative Vigor Non-Target Plant Study Using BY1 08330 150 

OD. Project Number: G20 1 834. Unpublished study prepared by Bayer CropScience LP. 15 p. 

Guideline: 123-2 Aquatic plant growth 

MRID: 46904451 

Dorgerloh, M. (2004) Pseudokirchneriella subcapitata - Growth Inhibition Test with BY1 08330 (tech.). 

Project Number: DOMl23092, El3231260612, P6041047065. Unpublished study prepared by Bayer Ag, 

Institute of Product Info. & Residue Ana. 129 p. 

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 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-en01 to the Waterflea Daphnia magna in a Static 

Laboratory Test System. Project Number: El320128 1218, EBFNMO 12. Unpublished study prepared 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 (Crassostrea virginica) Under FlowThrough Conditions. Project Number: 1379816175, EBFNXO11, M/257677/01/1. Unpublished study 

prepared by Springborn Smithers Laboratories. 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 study prepared 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 (Onchorhynchus mykiss). 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 Technical to the Sheepshead Minnow 

(Cyprinodon variegatus) Under Flow-Through Conditions. Project Number: EBFNX006, M/255363/01/1. 

Unpublished study prepared by Bayer Cropscience LP. 42 p. 

MRID: 46904460 

Nieden, D. (2005) Acute Toxicity of BY1 08330 OD 150 to Fish (Onchorhynchus mykiss) Under Static 

Conditions. Project Number: 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 study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 3 1 p. 

MRID: 46904475 

Nieden, D. (2005) Acute Toxicity of BY1 08330-en01 to Fish (Oncorhynchus mykiss). Project Number: 

EBFNMO 13, El28012 83417, PI6 841037060. 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 184310 112. Unpublished study prepared by Bayer Ag. 6 1 p. 

Guideline: 850.1400 Fish early-life stage toxicity test 

MRID: 46904442 

Dorgerloh, M. (2005) Early-Life Stage Toxicity of BYI 08330 tech. to Fish (Pimephales promelas). 

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 1 110212. 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 study prepared by Bayer Ag. 

44 p. 
MRID: 46904446 

Stoughton, T. (2006) Technical BY1 08330: A Subacute Dietary LC50 with Mallards. Project Number: 

EBFNXO 12, MI2743 8510 111. Unpublished study prepared by Bayer CropScience LP. 52 p. 

Guideline: 850.2300 Avian reproduction test 

MRID: 46904434 

Temple, D.; Martin, K.; Beavers, J.; et. al. (2006) BY1 08330 Technical: A Reproduction Study with the 

Mallard. Project Number: 1491208, EBFNP024. Unpublished study prepared by Wildlife International, 

Ltd. 162 p. 

MRID: 46904447 

Sabbert, T.; Nuessle, C. (2004) Effect of Technical BYI 08330 on Northern Bobwhite Reproduction. 

Project Number: EBFN0220, M/277757/01/1. Unpublished study prepared by Bayer CropScience LP. 

138 p. 

MRID: 46904448 

Sabbert, T.; Nuessle, C. (2005) Effect of Technical BYI 08330 on Mallard Reproduction. Project 

Number: EBFNXO 13, MI27779410 112. Unpublished study prepared by Bayer Cropscience LP. 154 p. 

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 mellifera L.) in 

the Laboratory. Project Number: 20091 035, MI08 122710112. Unpublished study prepared by Institut fUer 

Biologische Analytik und Consulting IBACON. 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 study prepared by 

Arbeitsgemeinschaft GAB 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 Terrestrial Plants: Final 

Report. Project Number: 06/10148/126. Unpublished study prepared 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 1R81 A102) in the 

Vegetative Vigour Test (Tier 1). Project Number: W06/09,08330, EBFNX103. Unpublished study 

prepared by Bayer Cropscience Gmbh. 17 p. 
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, 

MI28 86 1210 111. 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 study prepared by 

Bayer Ag, Institute of Product Info. & Residue Anal. 144 p. 

MRID: 46904476 

Dorgerloh, M. (2005) Lemna gibba G3: Growth Inhibition Test with BYI 08330-en01 Under Static 

Conditions. Project Number: EBFNX065, El4 121287610, MR113 1 103. Unpublished study prepared by 

Bayer Ag, Institute of Product Info. & Residue Anal. 120 p. 

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 subcapitata Growth 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 subcapitata Growth 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. 19 p. 

MRID: 46904576 

Schungel, M. (2005) BYI 08330 150 OD: Acute Toxicity in the Rat After Oral Administration. Project 

Number: Tl0075503, AT021 61. Unpublished study prepared 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: AT021 62, Tl2075523. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 24 p. 

MRID: 46904593 

Schungel, M. (2005) Acute Toxicity in the Rat after Oral Administration of BY1 08330. Project Number: 

T1075 865. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 24 p. 

MRID: 46904596 

Schungel, M. (2006) Acute Toxicity in the Rat after Oral Administration of BY1 08330. Project Number: 

T9076402. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 27 p. 

MRID: 46904598 

Schungel, M. (2006) Acute Toxicity in the Rat after Oral Administration of BY1 08330. Project Number: 

T3076767. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. 

MRID: 46904603 

Schungel, M. (2005) Acute Toxicity in 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 Fertility Effects Study of Rat. Project 

Number: 20142611. Unpublished study prepared by Bayer Corp. 1565 p. 

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 101341 113, LRT/RGlAl98/07, RGl37107. 

Unpublished study prepared 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 System Using Spiked Water. Project Number: EBFN0050, El4 16/28 1315, 

M/248099/02/2. Unpublished study prepared 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 

study prepared 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 Biotechnologie Gmbh. 1 17 p. 

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: 0511 01481032. Unpublished study prepared 

by Biochem Agrar, Lab her Biologische 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 study prepared by 

Arbeitsgemeinschaft GAB Biotechnologie. 88 p. 

MRID: 46904471 

Citation: Dorgerloh, M. (2006) Pseudokirchneriella subcapitata Growth Inhibition Test 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. Project Number: El3 101288416. Unpublished study prepared 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. Project Number: EBFN0347, El3221292818, 

P/604/057004. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 62 p. 

MRID: 46904478 

Citation: Dorgerloh, M. (2005) Acute Toxicity of BY1 08330-en01 to Larvae of Chrionomus riparius in a 

48 h Water-only Study. Project Number: EBFNX073, El3221292919, MR113 1 103. 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. Project Number: 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 Reproductive Toxicity in the Male Rat 

Following Daily Oral Administration by Gavage. Project Number: SAl0418 1. Unpublished study 

prepared by Bayer Cropscience. 196 p. 

MRID: 46904571 

Citation: Young, A. (2006) Technical Grade BYI 08330: A Dose Range-Finding Reproductive Toxicity 

Study in the Wistar Rat: Revised Report. Project Number: 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 study prepared 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. Project Number: RGFNYOO5. Unpublished study prepared by Bayer Corp. 

89 p. 

MRID: 47182302 

Citation: Stafford, J. (2007) Long-term Mallard Duck Dermal Exposure to BY1 08330. Project Number: 

13798141 14, EBFNP033. Unpublished study prepared by Springborn Smithers Laboratories. 46 p. 

MRID: 47182303 

Citation: Stafford, J. (2007) Semi-Field Study of the Effects of Dermal and Dietary Exposure to BY1 

08330 in Mallard Ducks (Anas platyrhynchos). Project Number: 1379814 1 1 6, EBFNP034. Unpublished 

study prepared by Springborn Smithers Laboratories. 1 19 p. 

MRID: 47276901 

Citation: Kolzer, U. (2007) Summary of Orientating Research Tunnel Trials on Effects of Spirotetramat to 

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 Government Reuorts Discussed in Assessment 

Burns, L.A. 2000. Exposure Analysis 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; Environmental Research Laboratory, Office of Research and Development, U.S. 

Environmental Protection Agency, Athens, GA. 
Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994. Literature review 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: correlation of 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 Leafy Vegetables. 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 Rate Analysis: 

Ecological Effects. Office of Pesticide Programs. Washington, D.C. 

U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment. Risk 

Assessment Forum, Office of Research and Development, Washington, D.C. EPAl630lR-951002F. April 

1998. 

U.S. Environmental Protection Agency. 2000. Risk Characterization Handbook. 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. Ecological Risk Assessor Orientation Package. Office of 

Pesticide Programs, 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 Pesticide Programs, 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 Ssk Assessment Process in the 

Office of Pesticide Programs. 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 Guidance for the Level I Screening 

Ecological Risk Assessments Conducted in the Environmental Fate and Effects Division. 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 Protection Agency. 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 Protection Agency. 2006. TerrPlant: Exposure to Terrestrial Plants including 

Wetlands.Version 1.2.2. Office of Pesticide Programs, Environmental Fate and Effects Division. 

December 26,2006. Washington, D.C. 

U.S. Environmental Protection Agency. 2007. Benchmark Dose Software, Version 1.4. lc. National 

Center for Enviromental Assessment, Office of Research and Development. Washington, D.C. 

httu://www.epa. govlncealbmds 

U.S. Environmental Protection Agency. 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=bc2dedal fD8 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 Persistence on 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 Laboratory USEPA, Athens, GA; AQUA TERRA Consultants, Mountain View, CA; 

and Waterborne Environmental, Inc., Leesburg, VA. p. 5-12.