UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREYENTION 

MEMORANDUM 

PC Code: 392201 

DP Barcode: 384525 

DE~ 5 r o tJ : 4-06 300 

Subject: (Revised) EFED Environmental Risk Assessment for the Proposed Uses of 

Spirotetrarnat on the Production of Cotton, Soybean, Legume Vegetables, 

Tropical Fruit, Pistachio, Okra, and Dried Prunes, Review of Risk to Pollinators, 

and Groundwater Label Requirement Revision. 

To: Rita Kumar, Risk Manager Reviewer 

John Hebert, Risk Manager, Rrn 07 

Meredith Laws, Branch Chief 

Insecticide-Rodenticide Branch 

Registration Division (7505P) 

From: Joseph Decant, Ecologist, Ecological Effects Reviewer 

Christina deMariano, Biologist, Ecological Effects 

b / 

JosC L. MelCndez, Chemist 

Environmental Risk Branch V 

Environmental Fate and Effects Division (7507P) 

Through: Mah T. Shamim, Ph.D., Branch Chief @p?!- /a / ?/lo 

Environmental Risk Branch V 1 

Environmental Fate and Effects Division (7507P) 

This revised memo addresses a series of requests made by Bayer Cropscience (BCS) related to 

the use of spirotetramat. The revisions include the addition of information related to the 

potential hazard to bees and appropriate label language or additional data needed to address this 

hazard. The revised memo also updates the data requirements remaining for spirotetramat. 

Similar to the original memo, this revised memo assesses the state of science regarding 

pollinators and the results of submitted studies as they pertain to bee label language and the field 

study requirement. It also deals with the groundwater label revision request proposed by the 

registrant. Finally, it addresses the risk to terrestrial and aquatic non-target species associated 

with new use registrations that are currently being requested for spirotetramat products for the 

following crops: cotton, soybean, legume vegetables, tropical fruit, pistachio, okra, and dried 

prunes (see Table 1 below for the proposed rates). 

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TEXT SEARCHABLE DOCUMENT - 2010
The major conclusions related to pollinators and the available information are as follows. The 

Environmental Fate and Effects Division (EFED) does not concur with the request of Bayer 

Cropscience in their white paper entitled, "Position Paper on Toxicity of Spirotetramat to Honey 

Bees" (MRID 47576401), to remove the label language restricting the spraying before and 

during bloom on cucurbits and citrus nor the removal of the label language stating, "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." Nor does the EFED concur with the request 

to consider fulfilled the condition of registration for MoventoTM for field testing with pollinators 

by the submission of the previous field studies and the additional data contained in the submitted 

data package (D357547). While two more field studies have been submitted, MRID7s 48159801 

and 48159802, these studies have not yet been evaluated. At present, the data gap therefore 

remains for Guideline 850.3040; Field Testing for Pollinators. 

The EFED has developed crop specific label language that can be used to eliminate exposure to 

pollinators for some crops, but not all crops. For tree fruits and tree nuts, as well as citrus. the 

EFED believes that additional data on translocated residues is needed to better characterize 

exposure. A field study that satisfies the Guideline 850.3040 will be held in reserve pending the 

outcome of residue characterization in the field. 

Regarding the groundwater label amendment, based on the laboratory and field studies, it 

appears that spirotetramat, spirotetramat-en01 and spirotetramat-ketohydroxy do not leach or 

persist substantially. Therefore, the EFED concurs with the registrant's label amendment 

request. The groundwater label advisory is not required. 

Finally, based on its review of the new studies and the proposed new uses, the EFED concludes 

that the risk picture for all proposed new uses is not substantially altered from the most recent 

assessment covering the currently registered uses of spirotetramat. While new studies have been 

recently submitted to fulfill OPPTS Guideline 850.1075 (Freshwater Fish Toxicity with Fathead 

Minnows) and OPPTS Guideline 850.2 1 00 (Avian Oral Toxicity Study with a Passerine 

Species), these studies are still in review. No additional data has been submitted on OPPTS 

Guideline 850.2300, Avian Reproduction Study with the Mallard Duck (Anas platyrhvnchos). 

The ecological risk assessment findings under that review (~345278') therefore pertain to this 

request. Please rely on the prior assessment and the additional information presented here for the 

evaluation of the ecological risk conclusions for the proposed new uses. The current status of the 

outstanding data requirements based on the previous risk assessment and new pollinator strategy 

are as follows: 

850.1075 Freshwater Fish Toxicity with Fathead Minnows: in review 

850.1350 Aquatic invertebrate life-cycle EstuarineIMarine: in reserve 

850.2100 Avian Oral Toxicity Study with a Passerine Species: in review 

850.2300 Avian Reproduction Study with the Mallard Duck (Anas platvrhvnchos): No 

data submitted 

' Appendices can be found at H:\EFED-Chem_Files\392201\Sec 3\D345278. 

- 3 - 
850.3040 Field Testing for Pollinators: in reserve 

Non-guideline Study for Systemic Field Residues with Tree Crops: No data submitted. 

The following discussion in this memo updates the previous memo (D362953, 363765, 358761) 

regarding the pollinator and groundwater label discussion, new use risk assessment and data 

requirements. 

Evaluation of Spirotetramat and Pollinators 

Request from Bayer CropScience 

New studies on the fate and toxicity of the spirotetramat parent compound and the major 

degradate.~ as they relate to pollinators have been submitted to the EFED since the last risk 

assessment2. Bayer CropScience submitted a document entitled "Position Paper on Toxicity of 

Spirotetramat to Honey Bees" (MRID 47576401), which states their rationale behind their threefold request as outlined below: 

1. The condition of registration for MoventoTM for field testing with pollinators be considered 

klfilled with the previous submission of two field studies and the additional data 

included in this data package. 

2. The environmental hazard statement should be amended as follows. Remove, "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." and replace with "No 

effects on the bee brood have been observed in field testing with Movento". 

3. The restriction on cucurbits and citrus to avoid spraying before and during bloom is not 

necessary and should be removed. The statement, "Do not apply until after petal fall7' 

should also be removed. This is redundant with the statement in the "Application 

Information" section of the label which will remain on the label and states, "Sufficient 

leaf tissue must be present for uptake and translocation of this product; due to this 

requirement, do not apply prior to petal-fall on pome fruits, stone fruits, and tree nut 

crops." 

Bayer CropScience proposes that their products containing spirotetramat are safe for pollinators 

as evidenced by field and semi-field trials with Apis mellifera. These studies range from residue 

studies in pollen, nectar, and blossoms to semi-field trials with spirotetramat spiked pollen to 

field trials using melon and citrus crops. 

Previous laboratory studies have illustrated the ability of spirotetramat to adversely affect bee 

brood (MRID 469044-70, 769044-58). These studies subjected honeybees to sugar solutions 

containing 0.0144% spirotetramat (equivalent to 144ppm in the bee food), and they found that 

spirotetramat has the ability to substantially affect bee brood development. Bayer subsequently 

MRID ~Abers 47576401,47563302,47563303,47563304,47563305,47563306,47563307,47563308, 

47563309,47563310,4756331 1,47563312. 

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sponsored a tunnel study to further evaluate the possible effects of spirotetramat to bee brood 

(MRID 472769-Ol), which also demonstrated the potential for spirotetramat to affect bee brood 

development. 

In response to these studies, Bayer CropScience countered that these studies represent unrealistic 

exposure scenarios. The laboratory studies, they contend, exposed the bees to unrealistically 

high concentrations that will not be found in the environment. Similarly, the bees exposed in the 

tunnel study were forced to forage on the contaminated crop, and therefore represent unrealistic 

worst-case exposure conditions. They therefore conducted two studies, a semi-field (MRID 

469044-59) test with oilseed rape and a field test (MRID 469044-62) with flowering lacy 

phacelia. In both studies, no adverse effects occurred in honey bee adults or brood. 

Despite these studies the EFED continued to state that risk to honey bee brood from 

spirotetramat could not be precluded. The EFED countered with the rationale that the tunnel 

study that showed effects to the bee brood exhibited effects lower than the maximum labeled 

application rate. The tunnel study by Bayer, which did not show effects, was conducted with 

application rates of approximately one-half the maximum labeled application rate. Similarly, in 

the field study conducted by Bayer not only were the highest single application rates 

approximately equal to half the maximum single proposed label application rate, but the overall 

total application rates were approximately half the maximum proposed label seasonal application 

rate. 

The conclusion of the EFED related to honey bee brood and development were based on a 

couple of reasons. The rationale was partly based on the nature of spirotetramat as an insecticide 

that has exhibited effects to bee brood under less than maximum application rates. The other 

part of the rationale was that two other related chemicals (spiromesifen and spirodiclofen) 

showed the potential for chronic effects to bee brood and development while displaying low 

acute toxicity. 

Review of Previously Submitted Studies 

The new studies submitted by Bayer CropScience are in response to the request for a field study 

that assesses the toxicity and exposure of spirotetramat to bees under field conditions. A total of 

11 studies were submitted for review to fulfill the Field Testing for Pollinators requirement in the 

conditional registration. A total of six studies were submitted that examined the residues of 

spirotetramat, which address the exposure of spirotetramat to pollinators. Two studies explore 

the toxic effects of spirotetramat over a range of concentrations in spiked pollen samples when 

given to bees in a tunnel design. Finally, three studies explore the toxicity of spirotetramat when 

bees are exposed under field conditions. The results of each study will be presented below along 

with the limitations of the studies that affect their ability to adequately assess the risk of 

spirotetramat to honey bee brood. 
47563302 Assessment of effects of Spirotetramat OD 150 on honey bee (Apis mellifera) 

colonies under a realistic field scenario in a melon crop in 2007 (non-GLP). 

Class2Jication: This field study is invalid due to the statistically signzjcant differences between 

treatment groups for average larval abundance and number of dead pupae before the jrst 

application as weN as the inability to confirm exposure affer the 2nd application. 

This study assessed the effects of total spirotetramat residues on honey bee colonies in a field 

study design at application rates of 72 g a.i.ka applied four times and 88 g a.i./ha applied four 

times. A review of the study revealed significant differences between the control plot and the 

both treatment groups for average larval abundance by a greater than 34% reduction in both 

groups compared to the control before the first application. For the average number of dead 

pupae, there was a reviewer-estimated effect on the number of dead pupae in the 72 and 88 g 

a.i./ha treatment group before the first treatment was applied. In addition, there were events of 

pupae expulsion from the hives in both treatment groups on different days after the first 

treatment. For the endpoint of number of dead worker bees per hive, the variability within 

groups was extremely high. The average number of dead worker bees was 4 times as high and 3 

times as high in the 72 and 88 g a.i.ka treatment groups as compared to the control, respectively. 

~urthermore, there was significantly higher mortality in the treatment groups before application 

of the test material. In summary, many of the endpoints exhibited high variability or significant 

differences between groups even before the first application, which does not allow for 

meaningful comparisons between treatment groups. 

A number of other limitations arose in the study. The study authors reported that a flower 

density equivalent to approximately 200 melon blossoms/100 m is sufficient to provide an 

attractive.food source for honeybees. However, the crop fell below this threshold after the 2nd 

application. The study authors did not provide a reference for this critical threshold. The study 

authors also stated that a positive proof of the absence of effects could only be provided for the 

study period up to the T1 assessment, because they were uncertain about exposure in the period 

after the 2nd application. The plots were located only three kilometers apart from each other, 

which is within the foraging range of a honeybee (Beekman and Ratneiks, 2000). The study 

showed high variability in the controls. Melon plants on almost all of the plots were heavily 

infested with Bemisia sp., so thiacloprid and deltarnethrin were used to control the infestation. 

Finally, the study authors did not confirm foraging through pollen identification or exposure 

through pollednectar analysis. 

47563303 Assessment of effects of Spirotetramat OD 150 to honey bee (Apis mellifera) 

colonies under a realisticwd scenario in a melon crop. 

Classzjcation: This study is supplemental because it provides information about the effects of 

spirotetramat on bees in a Jield scenario; however, the study did not conjrm foraging or 

exposure through pollen identification or pollen/nectar analysis, showed reduced foraging 

potential after the fourth application of the test material, and did not quantijj foraging on the 

crop. 

- 5 
The study authors examined the effects of total spirotetramat residues on honey bee colonies in a 

field study setting with a melon crop. The study was conducted at three rates: 0 for the control, 

75 g a.i./ha applied four times, and 88 g a.i./ha applied twice. There was no evidence of any 

treatment related effects in any of the endpoints measured. 

There were a number of aspects related to this study that limit the inferences that can be drawn 

from it. All of the treatments exhibited high variability, which may either have masked the 

effects from the test material or may have reflected natural variability in bee colonies. After the 

fourth application of the test material, there was an observed decrease in blossom density. This 

decrease was reported as being normal due to the crop being cultivated later than is done 

regionally that resulted in a shortened flowering period. The plots were again only 3km apart. 

The study authors did not confirm foraging through pollen identification or exposure through 

pollenJnectar analysis. Finally, the study author stated that they obtained visual verification of 

exposure by observing bees on the blossoms, but this conclusion was not quantified. 

47563304 Assessment of Side Effects of Spirotetramat OD 150 on the Honey Bee (Apis 

mellifera L.) Applied to Citrus in the Field in Spain. 

ClassiJication: This study is su~~lemental because it shows the effects of spirotetramat on bee 

brood in afield setting, but it also shows high variability in the endpoints and that little citrus 

pollen was foraged by bees in the treatment group suggesting limited exposure to the chemical. 

This study assessed the effects of total spirotetramat residues to honey bee colonies in citrus 

crops in Spain. The chemical was applied at a rate of 192.0 g a.i./ha, which was applied at two 

different times and separated by three weeks. The treated and the control orchards were 

appropriately far away from each other (15km). There was no evidence of any treatment related 

effects in any of the endpoints measured. 

This study using citrus crops showed that total spirotetramat residues would not result in any 

adverse effects to honey bee colonies. Yet, the study also showed some results that question the 

usefulness of the study. High variability in the endpoints was apparent in both of the treatments 

in the study. A review of the study revealed that on a day to day basis, the control and treatment 

orchards would exhibit increased mortality or decreased foraging as compared to one another. 

But the effects were minimized when considering the entire post-application period due to the 

high daily variability. The pollen and nectar analysis showed the accumulation of small amounts 

of spirotetramat in the pollen, but not the nectar, inside the hives of the bee colonies (<0.01 to 

0.03 mg/kg of spirotetramat and <0.01 to 0.15 mg/kg of BYI08330-enol). The study authors 

identified the pollen in the hives and remarked that the bees in the control group foraged on a 

variety of crops including citrus (from 8.7% on day 26 after the second application to 23.7% on 

day 14 after the second application) whereas in the treated orchard little citrus pollen was 

collected (from 1 .O% on day 26 after the second application to 2.7% on day 7 after the second 

application). This data shows that bees were foraging on other crops besides citrus and may 

imply that spirotetramat has repellent properties. Furthermore, the residues of spirotetramat 

- 6 
found inside the hive could not be compared to the citrus residue study (MRID 47563312) that 

could not verify the chemical concentrations in the pollen. This comparison would have 

confirmed if the concentration found in this study could be realistic or simply an artifact of a lack 

of foraging on the treated crop. 

47563305 Determination of Effects of Spirotetramat in Spiked Pollen to Honeybee Brood 

under Semi-Field Conditions (Trial 2008). 

ClassiJication: This study is supplemental as it illustrates the impact of spirotetramat in a food 

source over a range of concentrations, but it also revealed several limitations such as high 

variability in the endpoints in all treatment groups, a decrease in larval and pupal abundance in 

all treatment groups until the bees were allowed to forage, and the lack of pollen storage inside 

the hive. 

The purpose of this study was to assess the effects of pollen spiked with total spirotetramat 

residues on honey bee colonies and their brood. The study authors reported no effects on brood 

or brood development after feeding small honeybee colonies for 21 days with the spiked pollen 

with nominal concentrations covering a range of 0, 2, 10, and 20 mglkg. In addition, there 

appeared to be no adverse effects on comb development, hive weight development, honey and 

pollen storage behavior, and foraging activity. After exposure the bees were allowed to forage 

outside of the tunnels. 

The study provided an assessment of total spirotetramat residue toxicity to honey bee brood in a 

tunnel design. This design ensured that the only food source for the hives would be the food 

provided by the study authors, which were the spiked pollen and spirotetrarnat free honey. The 

study showed no adverse effects to any endpoint, however the data also showed some results that 

question the applicability of the study. First, the honeybees in all of the treatments did not store 

pollen in the hives until they could forage outside of the tunnel, yet they stored honey from a 

feeder outside the hive over the course of the whole study. The study authors state that the bees 

did not store pollen because they considered the pollen in the petri dish inside the hive to be a 

part of the comb. This rationale should be a part of future research into this method given the 

propensity of honey bee behavior to store pollen and nectar in the hives. Second, all of the 

treatments, including the controls, showed a decrease in larval and pupal abundance over the 

course of the study until the bees were allowed to forage outside of the tunnel, at which point 

both parameters increased in the various treatments. Finally, the different treatments showed 

high variability in the endpoints with only three replicates per treatment, which may be a result 

of natural honey bee colony variability or may mask any treatment level effects. 

47563306 Determination of Effects of BY108330 in Spiked Pollen to Honeybee Brood under 

Semi-Field Conditions (Trial 2006). 

Classification: This study is supplemental because it provides useful information about the 

effects of spirotetramat on bees in a tunnel design, but it also has deficiencies such as the lack of 

pollen collection inside the hive and the study design lacked replication. 

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This study examined the effects of pollen spiked with a range of concentrations of total 

spirotetramat residues. The concentrations were 0, 0.05, 0.2, 0.5, 2, and 10 mglkg. The bees 

were exposed for 22 days to spiked pollen through a feeder placed outside the hive and one 

placed inside the hive. After exposure the bees were allowed to forage outside of the tunnels. 

The study authors concluded that a slight transient effect to larval abundance in the highest 

treatment group could not be excluded. They also reported that there were no adverse effects to 

other brood-related endpoints, comb development, hive weight development, honey and pollen 

storage behavior, foraging activity and mortality by foraging on and consumption of pollen 

containing up to lOmg BY108330 and BYI08330-enollkg pollen. After a review of the results 

however, egg deposition appeared to decrease at all levels, including the controls. 

While the study employs a tunnel design to ensure exposure, the study has a number of 

deficiencies that render it of little use in risk assessment to pollinators. The study authors did not 

conduct statistical analyses on the data for each endpoint. The mortality data are presented as the 

number of dead bees found, but the exact number of bees in each treatment level at test initiation 

is not known so that percent mortality could not be determined. The honey was placed in a 

feeder outside of the hives, whereas spiked pollen was placed in two feeding dishes- inside the 

tunnel, one inside the hive and one outside the hive. The bees collected honey and stored the 

honey inside the hives; however they did not store pollen in the combs. The study authors state 

that the bees did not store pollen because they considered the pollen in the petri dish inside the 

hive to be a part of the comb. This rationale should be a part of future research into this method 

given the propensity of honey bee behavior to store pollen and nectar in the hives. The most 

important deficiency is the lack of replicates in the study, which places the results in question 

because statistical analyses cannot be performed on the data and severely limits the usefulness of 

the study. 

47563307 Residues of Spirotetramat and its metabolites in blossom samples of melons after 

spray application in Spain. 

Classification: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in melon blossoms, but it was not conducted according to any 

established guideline. 

This study assessed the magnitude of residues of spirotetramat in melon blossoms at two rates of 

72 and 288 g a.i./ha. The study concluded that total residues can persist as long as 10 days after 

application. Total residue concentrations were 1.463 mglkg after three hours post application in 

the 72 g a.i./ha treatment and 4.690 mglkg after three hours post application in the 288 g a.i./ha 

treatment. This study showed that residues persisted in melon blossoms after both application 

rates. 

47563308 Residues of Spirotetramat and its metabolites in nectar and pollen samples of 

melons after spray application (tunnel tesl) in Spain. 

- 8 
Classzfication: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in honey bee nectar and pollen after foraging on melon blossoms, 

but it was not conducted according to any established guideline. 

The study authors assessed the magnitude of total residues of spirotetramat in nectar and pollen 

collected by honeybees (Apis mellifera) from melon crops in a tunnel design. Spirotetramat was 

applied at two rates: 96 and 288 g a.i./ha. The nectar and pollen were collected from inside the 

hive. Two different application times provided a comparison of total residues when applications 

were made five days before flowering or at full flowering. The maximum concentrations based 

on the sampling design inside the hives were 0.306 mgkg after an application of 288 g a.i./ha at 

17 days after treatment and 0.213 mglkg after an application of 96 g a.i./ha at 11 days after 

treatment. The study addresses the accumulation of spirotetramat in honeybee nectar and pollen 

stores, but it did not include control plots. More importantly, the sampling showed increasing 

concentrations of spirotetramat in the hives over time. Yet the sampling did not capture the point 

at which concentrations remained constant or decreased, which suggests that the study may not 

have captured the maximum concentrations inside the hives. 

4 7563309 Residues of Spirotetramat and its metabolites in citrus blossoms after spray 

application in Spain. 

Classification: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in citrus blossoms, but it was not conducted according to any 

established guideline. 

This study examined the concentrations of spirotetramat in citrus blossoms with a total 

application rate of 112.5g a.i./ha applied two times. The upper bound of reported total residues 

reached 0.742mg/kg, with a mean value of 0.591mglkg. The study showed that total residues of 

spirotetramat will accumulate in citrus blossoms. The study was limited in that it failed to use 

the maximum labeled rates, but in fact used a rate approximately one-half of both the maximum 

application rate and the maximum seasonal application amount. 

47563310 Residues of Spirotetramat and its metabolites in nectar and pollen of phacelia after 

spray application in Germany. 

Classfication: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in phacelia nectar and pollen collected from inside bee hives, but 

it was not conducted according any established guideline, they did not describe their methods for 

analyzing the honeybee toxicity endpoints or condition of the bees, and the study did not have a 

control treatment. 

The focus of this study was on the total residues of spirotetramat in nectar and pollen collected 

by bees (A. mellifera). The chemical was applied at a rate of 100 g a.i./ha over phacelia, and 

- 9 
residues in pollen and nectar were collected from inside the hive. Analysis showed that total 

spirotetramat residues in pollen accumulated to a maximum of 6.35 mglkg at 4 days after 

application. In addition, concentrations tended to remain high where the upper bound of total 

residues was 4.51 mglkg at 10 days after application. However, total residues in nectar showed 

much lower concentrations with a maximum of 0.33 mg/kg at 4 days after application and an 

upper bound of 0.23 mglkg at 10 days after application. The study found no effects to any 

measured endpoint in the honeybee colony. 

The study showed that total spirotetramat residues can accumulate in the pollen and nectar of 

honeybee hives after foraging on treated phacelia and persist for at least ten days. However, the 

study had a number of limitations. The authors did not describe their methods for analyzing the 

honeybee toxicity endpoints, and the source, health, and age of the bees of the honeybee colony 

were not reported, and most importantly the study did not have a control treatment. 

4 756331 1 Residues of Spirotetramat and its metabolites in nectar and pollen of summer 

oilseed rape after spray application in Germany. 

Classz~cation: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in nectar and pollen from summer oilseed rape collected from 

inside bee hives, but it was not conducted according to any established guideline, they did not 

describe their methods for analyzing the honeybee toxicity endpoints or condition of the bees, 

and the study did not have a control treatment. 

Similar to the study on phacelia nectar and pollen, this study focused on the total residues of 

spirotetramat in nectar and pollen collected by bees (A. mellfera). The chemical was applied at 

a rate of 100 g a.i./ha over oilseed rape, and residues in pollen and nectar were collected from 

inside the hive. Analysis showed that total spirotetramat residues in pollen exhibited a maximum 

of 8.31 mglkg at 6 days after application. In addition, concentrations tended to remain high 

where the upper bound on total residues was 7.14 mglkg at 7 days after application. However, 

total residues in nectar showed much lower concentrations with a maximum of 0.06 mglkg at 4 

days after application and an upper bound of 0.04 mglkg at 7 days after application. The study 

found no effects to any measured endpoint in the honeybee colony. 

The study showed that total spirotetramat residues can accumulate in the pollen and nectar from 

honeybee hives after foraging on treated oilseed rape and persist for at least ten days. However, 

the study had a number of limitations. The authors did not describe their methods for analyzing 

the honeybee toxicity endpoints, and the source, health, and age of the bees of the honeybee 

colony were not reported, and most importantly the study did not have a control treatment. 

47563312 Residues of Spirotetramat and its metabolites in nectar and pollen of citrus after 

spray application in Spain. 
ClassiJication: This study is supplemental as it provides useful information related to the 

accumulation of spirotetramat in citrus nectar and pollen collected from inside bee hives, but it 

was not conducted according to any established guideline nor did it assess the accumulation of 

spirotetramat in pollen stores in the hive. 

This study focused on the total residues of spirotetramat in nectar and pollen collected by bees 

(A. mellifera) in a crop of citrus. The chemical was applied twice at a rate of 75 g a.i.kalm 

canopy height over citrus, and residues in nectar were collected from inside the hive. Analysis 

showed that total spirotetramat residues in nectar did not accumulate to quantifiable 

concentrations throughout the entire study. The study failed to assess the accumulation potential 

of spirotetramat residues in pollen because there was not enough pollen to sample. In addition, 

the application rate was approximately one-half of both the maximum application rate and the 

seasonal application rate. 

EFED Response 

In summary, these studies show that total spirotetramat residues will accumulate in the blossoms 

of various crops up to a maximum of 4.69 mglkg after a treatment of 288 g a.i./ha in melon and 

0.591 mglkg after a treatment of 112.5 g a.i./ha applied twice in citrus. The residues accumulate 

in the pollen stores of a hive based on specified application and sampling times at 0.306 mglkg 

after a treatment of 288 g a.i./ha in melon, 6.35 mglkg after a treatment of 100 g a.i./ha in 

phacelia, and 8.3 1 mglkg after a treatment of 100 g a.i./ha in oilseed rape. 

These studies also show that in a tunnel study design where honey bees are forced to forage on 

pollen spiked with spirotetramat and its metabolites the results can be mixed. The tunnel study 

in 2006 (47563306) showed slight transient effects at 10 mglkg. The NOAEC would therefore 

be 2 mglkg based on this study. However, a similar study in 2008 (47563305) showed no effects 

at any treatment level up to 20 mg/kg. Both of the field studies (47563303, 47563304) showed 

no advers.e effects to any endpoints. 

It would appear that spirotetramat exposure to the brood, which is conclusive based on the 

residue analyses of the pollen and nectar stores inside the hives in the tunnel studies, will not be 

toxic to honeybees at the application rates tested in the field studies. Furthermore, the tunnel 

studies with spiked pollen show that adverse effects would not occur at concentrations up to 2 

mglkg based upon the 2006 tunnel study (47563306). 

Yet, as previously reviewed, these studies have some substantial limitations in addressing the 

potential toxicity of spirotetramat to honey bee colonies. The deficiencies range from high 

variability and few replicates (47563305, 47563303, and 47563304), questionable hive 

performance given differences between treatments even before chemical application (47563302), 

questions of exposure related to a decrease in blossom density or the lack of pollen identification 

analysis (47563302, 47563303), application rates lower than the maximum labeled use rate and 

maximum seasonal rate (47563309, 475633 12), a lack of method reporting for toxicity endpoints 

(47563310, 475633 1 I), a sampling design that may not have captured the maximum exposure 

11 
level (47563308), to a complete lack of replicates (47563306). Also, concentrations in citrus 

pollen stored inside the hives were not assessed in the field residue study (47563304) even 

though one of the requested actions is to remove the restriction of applying spirotetrarnat to 

blooming citrus. 

An additional limitation of the studies arises from the nature of the risk posed by spirotetramat. 

Previous laboratory studies showed effects to the brood. The current studies show that 

spirotetramat may affect larval abundance (47563306). They also show that spirotetramat 

residues will accumulate and persist in the hives of honey bee colonies. In fact, even though the 

NOAEC as established in the 2006 tunnel study (47563306) is questionable given the high 

variability in the control treatment endpoints, concentrations in the semi-field residue studies for 

phacelia and oilseed rape were greater than this value. Both of these aspects of toxicity and 

exposure, together with the results of the previous laboratory studies, suggest that chronic risk 

needs to be the assessment goal in the field study. However, the maximum length of time that 

these studies assessed the honey bee colonies was approximately 1.5 months (47563303, and 

47563304). 

The EFED does not concur with the requested label changes as requested by Bayer 

CropSciences. An application to blooming citrus or cucurbits could increase the exposure to 

adult bees, which would then allow the adult foragers to return and expose the hive to these 

higher pesticide loads. The removal of protective labeling language related to the effects to 

honey bee broods is inappropriate considering that as previously discussed the recently submitted 

studies have deficiencies that do not allow for a sufficient analysis of exposure and potential 

chronic effects to the brood of honey bee colonies. These deficiencies do not provide sufficient 

evidence to alter the EFED's assessment of the risk of spirotetramat to pollinators and beneficial 

insects as outlined in the attached previous risk assessment. 

Finally, given these deficiencies and the need to assess chronic risk, the most recently submitted 

studies do not satisfy the requirements of a field study. Previous responses and comments by RD 

and the EFED recommended submitting a proposed study design and working with the EFED to 

establish a testing protocol before the study would be implemented. However, the EFED 

believes that crop specific labeling could eliminate exposure for most crops, which may also 

affect the need for a pollinator field study. The EFED has further assessed those crops for which 

specific label lan~uage should be applied. For more information see the revised memo regarding 

crop specific labeling (D379926). 

Specificallv related to the new uses, the label language, "Do not apply until after petal fall" 

is appropriate for the following crops: 

1. Stone Fruits: dried prune 

2. Tree Nuts: pistachio 

Minor crops and/or crops which may be attractive to bees under some conditions, but do 

not warrant crop-specific labeling: 
3. Others: Soybean, legume vegetables, tropical fruit, okra 

Potential hazard from exposure which cannot be mitigated by labeling: 

Cotton: Because cotton has extrafloral nectaries which produce nectar throughout the growing 

season, bees are attracted to the crop even after actual bloom has ceased. Thus, bee precautions 

based on bloom do not mitigate the hazard. The following websites discuss the nature of 

extrafloral nectaries in cotton: 

The crops included in the currently proposed new uses are also included in the revised memo on 

crop specific labeling (D379926). The EFED identified uncertainties in exposure for citrus and 

tree fmits and tree nuts based on the protective label language. The EFED therefore developed a 

strategy to address any remaining uncertainties in exposure. A previous memo (D380617) 

established the current strategy of EFED related to spirotetramat regarding pollinators as follows: 

"The Environmental Fate and Effects Division (EFED) identifies that the period of concern for 

spirotetramat applications, given its systemic nature, is the period before bloom, during bloom, 

and until petal fall is complete. Therefore, EFED believes that the label statement, "Do not 

apply until after petal fall", will be sufficiently protective for most crops. Given the systemic 

nature of spirotetramat, however, there is uncertainty regarding the potential for carry-over of 

residues from one growing season to the next for tree crops. Thus, studies should be conducted 

to determine whether residues will remain in tree crops following post petal-fall application of 

spirotetramat in the previous season at the maximum application rate. Bayer Cropscience (BCS) 

should consult with EPA in development of the protocols for these studies. 

For citrus, EFED suggests that the original label statement, "Do not apply this product within 10 

days prior to bloom, during bloom, or until petal fall is complete", may be used. Data should be 

submitted to EPA to confirm and quantify levels of residues in citrus leaves, pollen, and nectar 

after applications at different times before bloom. The purpose of the study is to evaluate residue 

levels at 10 days before bloom and prior to 10 days before bloom in order to better evaluate 

exposure to bees, and, if necessary, to revise the appropriate pre-bloom "window" necessary to 

protect pollinators. Again, study protocols should be developed through consultation with EPA. 

The previous requirement for a pollinator field study with spirotetramat will be placed in reserve, 

pending the outcome of the residue studies. Should the residue studies indicate potential for 

pollinator exposure in spite of the application restrictions, field studies may be required. 

BCS has submitted a letter to EPA regarding amended bee label safety language that EPA has 

proposed for spirotetramat labels. BCS states that the language proposed by EPA for tree crops, 

"Do not apply until after petal fall", is not appropriate for citrus, as it is unclear, is inconsistent 

with a recent memo from EFED, and does not provide enough detail to specify a definite 

11 
application window. In addition, BCS states that this label statement is scientifically 

unacceptable based on the extensive existing dataset, and it renders impractical the uses for 

melon and citrus. According to BCS, two studies on citrus are in the process of being prepared 

for submission to EPA, which show that spirotetramat does not pose any risk to bees at realistic 

application rates to citrus. BCS therefore proposes the original label language for citrus: "Do not 

apply this product within 10 days prior to bloom, during bloom, or until petal fall is complete." 

EFED has reviewed this position statement by BCS. EFED stated in the previous memo that for 

certain crops, the potential hazard to bees could be "mitigated by current labeling," which is the 

proposed label language of "Do not apply until after petal fall". EFED believes that this label 

language will be sufficient for the majority of crops, due to the application window defined by 

leaf fall or harvest. However, EFED agrees with BCS that this label language, "Do not apply 

until after petal fall", is unclear for citrus, because citrus produces new growth year-round with 

no clear endpoint to the treatment season. Thus, the original label statement, "Do not apply this 

product within 10 days prior to bloom, during bloom, or until petal fall is complete", is 

appropriate for citrus, unless data from citrus residue studies indicate that a longer pre-bloom 

restriction is needed." 

In summary, the previous field studies to date have been found to be insufficient to address the 

hazard of spirotetramat to bee brood and hive survival. Protective label language has been 

identified for most crop uses. Uncertainties in exposure remain for citrus, tree fruits, and tree 

nuts given the systemic nature of spirotetramat. Therefore, the EFED is requesting nonguideline studies to be conducted that address the systemic residues in these crops while a field 

study on the toxicity of spirotetramat (850.3040) is being placed in reserve pending the outcome 

of the residue studies. If the residue studies show that bees will continue to be exposed to 

spirotetramat residues despite the protective label language, then a field study may be requested 

to satisfy Guideline 850.3040. 

Groundwater Label Requirement Revision 

Request from Bayer Cropscience 

BCS also requested to amend the labels of Spirotetramat Technical and its three end use 

products.3 The registrant proposed to remove the following advisories from the labels: 

Technical Label: "This chemical has properties and characteristics associated with. chemicals 

detected in ground water. The use of this chemical in areas where soils are permeable, 

particularly where the water table is shallow, may result in ground water contamination." 

Letter from L. Hodges to R. Kumar, Identified as EPA Correspondence No. 09-03S, dated Feb. 5,2009, Re: 

Application to Amend the Registration of ~Spirotetramat Technical (EPA Reg. No. 264-1049); ~Movento (EPA 

Reg. No. 264-1050); .BY1 8330 150 OD Insecticide (EPA Reg. No. 264-1051); 0ULTOR (EPA Reg. No. 264- 

1065). 

- 14 
End Use Products Labels: "This chemical has properties and characteristics associated with 

chemicals detected in ground water. This chemical may leach into ground water if used in areas 

where soils are permeable, particularly where the water table is shallow." 

The registrant cited two submissions in support of their request, a photolysis on soil study, using 

a sterile soil (MRID# 47576502), which was accompanied by a position paper (MRID# 

47576501), related to the nature of the non-extractable residues (NER). The Agency has 

reviewed .the soil photolysis study (supplemental). Moreover, BCS has indicated that: 

Mobility and persistence: The Kd3s are 4.1, 16.8 and 1.0 mL/g for spirotetramat, 

spirotetramat-en01 and spirotetramat-ketohydroxy, respectively, but they degrade rapidly. 

Degradation: The mean half-lives are 0.21, 0.10 and 6.9 days, respectively. The half-life 

for the combined residues of spirotetramat-enol, spirotetramat-ketohydroxy and 

spirotetramat-MA-amide from the spirotetramat-en01 study was a mean of 16.8 days. 

The Non-Extracted Residues (NER) should not be considered as relevant residues or in 

half-life calculations and should not be considered mobile. 

The results of the terrestrial field dissipation confirmed the rapid degradation and low 

mobility of spirotetramat residues. The DTSOs for the combined residues of spirotetramat, 

spirotetramat-en01 and spirotetramat-ketohydroxy was 9.5 days for the four sites, with 

residues remaining in the top soil layers. 

The results obtained from the tier 1 groundwater model SCI-GROW were less than 0.4 

ppt, indicating a low potential for groundwater contamination. 

EFED Response 

EFED concurs with BCS' request, and BCS should request to amend the labels accordingly. 

According to the Label Review Manual (http://www.epa.~ov/oppfeadl/labelin~/ld ), "The 

need for a ground water label advisory is based on the environmental fate properties of the 

chemical andor detections of the chemical in ground water." According to the manual, there are 

two criteea to be used. First, the mobility of the chemicals should be evaluated: e.g., if Kd is less 

than 5 or the field dissipation results indicate that the chemical leaches. Second, the chemical's 

persistence is examined; e.g., the hydrolysis half-life is greater than 30 days at any pH or the 

aerobic soil metabolism half-life is greater than 2 weeks. 

The Kd for spirotetramat ranges from 3.58 - 5.52 mL/g, for spirotetramat-enol, it is 10.86 mL/g, 

and for spirotetramat-ketohydroxy, it is 12.28 mL/g. These values suggest high mobility for all 

the three compounds. Nonetheless, in terrestrial field dissipation studies, conducted in NY, CA 

and WA,.including both, cropped and bareground plots (a total of 5 trials), the test substances 

were confined in the upper 0-15 cm soil depth. In the study conducted in FL, all three test 

substances were also observed in the 15-30 cm soil depth at 1 and or 7 days (but not at 3 days), 

but they were not detected in the 15-30 cm soil depth above the LOQ after the 7 days test 

interval. Despite their low Kd values, the field dissipation studies suggest that these test 

substances do not leach substantially under field condition. 
For spirotetramat, the hydrolysis half-lives are 32.5-47.6 days (pH 4); 8.6-13.1 days (pH 7); and 

0.32 days (pH 9). Spirotetramat-en01 was stable to hydrolysis at a pH range of 4 to 9 and 50°C 

for 5 days. Finally, for spirotetramat-ketohydroxy, there is no hydrolysis study, but the aerobic 

aquatic metabolism study suggests that it could be persistent to hydrolysis. Despite the 

hydrolysis half-lives are >30 days in some instances, the aerobic soil metabolism is very rapid. 

For spirotetramat, it is 10.30 days (four soils), for spirotetramat-en01 it is 10.16 days (four soils), 

and for spirotetramat-ketohydroxy, it is 1.5-5.1 days for three soils, and 16.7 days for one soil. 

These aerobic soil metabolism half-lives suggest that spirotetrarnat, spirotetrarnat-en01 and 

spirotetramat-ketohydroxy are not persistent. This is substantiated by the results of the terrestrial 

field dissipation studies, where the half-lives for the total residues of spirotetramat, 

spirotetramat-en01 and spirotetramat-ketohydroxy, in six trials conducted in FL, CA and WA 

(cropped and bareground plots) were in the rage of 5.0 - 10.2 days. For a field study conducted 

in NY (bareground plot), the half-life was slightly higher, 23.4 days. 

Based on the laboratory and field studies, it appears that spirotetramat, spirotetramat-en01 and 

spirotetramat-ketohydroxy do not leach or persist substantially. Therefore, the EFED believes 

that the groundwater label advisory is not required. 

The issue of the NER has been deferred and will be considered at a later time since no 

exceedances of the levels of concern were observed for the total spirotetramat residues (see also 

D358765+). 

Risk Assessment 

Based on the maximum exposure scenario allowed under these new uses, exposure modeling was 

conducted with the EFED's PRZMIEXAMS, T-REX (T-REX, Version 1.3.1, dated December 7, 

2006), and TerrPlant (v1.2.2) models to estimate exposure to aquatic organisms (Tables 2 and 

3), terrestrial animals (Table 4), and upland and wetland plants (Table 5), respectively. Based 

on the results of T-REX and TerrPlant, the estimated environmental concentrations (EECs) were 

less than the highest EECs estimated in the previously conducted risk assessment, 

"Environmental Fate and Ecological Risk Assessment for the Section 3 Registration of the New 

Chemical Spirotetramat (DP Barcode 345278; Dated May 30, 2008)" (based on the more 

conservative total residues approach discussed in the assessment). Only EECs for terrestrial and 

aquatic organisms are presented below to demonstrate that exposure, and therefore risk, for the 

proposed new uses will be lower than for the currently registered uses. 

Based on its review, the EFED concludes that the risk picture for all proposed new uses is not 

substantially altered from the previously mentioned assessment covering the currently, registered 

uses of spirotetramat. The ecological risk assessment findings under that review therefore 

pertain to this request (copy attached4). Please rely on the prior assessment and the additional 

information presented here for the evaluation of the ecological risk conclusions for the proposed 

new uses. Data requirements can be found in Tables 6 and 7. 

4 Appendices can be found at H:\EFED-Chem-Files\392201\Sec 3\D345278. 

- 16 
me Fruit (Crop Group 1 1, 
and winter type squash like acorn 

squash, calabaza and others), and 

Fruiting Vegetables (Crop Group 8 

plus including eggplant, 

groundcheny, okra, pepinos, peppervarious kinds, tomatillo and tomato) 

Leafy Vegetables (Crop Group 4 

including amaranth-various kinds, 

arugula-roquette, cardoon, celery, 

celtuce, chervil, Chinese celery, 

chrysanthemum, corn salad, garden 

cress, cress-various kinds, dandelion, 

sorrel dock, endive, Florence fennel, 

lettuce-head and leaf, orach, parsley, 

garden and winter purslane, 

radicchio-red chicory, rhubarb, 

spinach-various kinds, Swiss chard) 

0.08 

0.08 

2 

2 

0.16 

0.16 

7 

7 

(3, A, 

Chemigation 

G, A. 

Chemigation 

1 

3 
Table 1. 'Summary use information for spirotetramat, based on BY1 8330 150 OD Insecticide (oil 

. No. 264-1051) and MOVENTOTM (suspension concentrate) labels (Reg. No. 264-1050). 

Proposed New usesd 

(FL avocado aerial/ 1 4.89 1 4.84 1 4.78 1 0.0074 1 0.0089 

Currently Registered Uses 

(NC apples aerial; 0.4; 3; 7) 

0.12+0.12+0.14/ 31 14) I 

* The representative modeled exposure scenario for spray applications of spirotetramat to agricultural crops 

resultingin the highest EECs. ~p~lication rate in lb &./A and interval between applications in days. 

Highest calculated acute RQs are for fkeshwater invertebrates. Toxicity values are based on studies with midges 

(Chironomus riparius) for freshwater invertebrates (ECSo = 660 pg a.i./L). All RQs from the previous assessment 

and for the proposed new uses are below the Agency's acute risk (0.5), acute restricted use (0. I), and acute 

endangered species (0.05) LOCs. 

' Highest calculated chronic RQs are for freshwater fish. Chronic toxicity values are based on studies with fathead 

minnows (Pimephalespromelas) for freshwater fish (NOAEC = 534 pg a.i./L). The chronic risk LOC is 1. 

Therefore, all chronic RQs from the previous assessment and for the proposed new uses are below the Agency's 

chronic LOC. 

Includes non-extracted residues in the EECs. 

INTERVAL 

BETWEEN 

APPS. (days) 

7 

7 

USE 

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) 

Potato and Other Tuberous and 

Corm Vegetables (Crop Subgroup 

I C including arracacha, arrowroot, 

artichokeChinese and Jerusalem, 

edible canna, bitter and sweet 

cassava, chayote-root, chufa, 

dasheen-taro, ginger, leren, potato, 

sweetpotato, tanier, turmeric, yam 

bean, true yam) 

11.4 

NUMBER 

OF APPS. 

2 

2 

SINGLE 

APP. RATE 

(Ibs. a.i./A) 

0.08 

0.08 

APP. 

METHOD 

G, A, 

Chemigation 

G, A, 

Chemigation 

SEASONAL 

APP. RATE 

(I. aA) 

0.16 

0.16 

11.1 

PHI 

(days) 

1 

7 

10.8 0.0173 0.0202 
0.12+0.12+0.14/ 31 14) 

a The representative modeled exposure scenario for spray applications of spirotetramat to agricultural crops resulting 

Currently Registered Uses 

(NC apples aerial; 0.4; 3; 7) 

Proposed New Usesc 

(FL avocado aerial1 

. -- 

in the highest EECs. ~pplication rate in 1b a.i./A andinterval between applications in days: - 

Toxicity values are based on studies with duckweed (Lemna gibba) for vascular plants (ECS0 = 4620 pg a.i./L; 

NOAEC=1540 pg a.i./L) and marine diatoms (Skeletonema costatum) for non-vascular plants (EC5, = 360 pg a.i./L; 

NOAEC=124 pg 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. All of the highest calculated RQs fiom the previous assessment and 

for the proposed new uses are below the acute LOC (1) for aquatic plants. Therefore, all RQs for both vascular and 

non-vascular aquatic plants for all uses are below the Agency's LOCs. 

Includes non-extracted residues in the EECs. 

11.4 

4.89 

0.0317 

0.0136 

0.0025 

0.001 

0.0919 

0.0394 

0.0074 

0.0032 
0.16 lb &A 

" EECs 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 with aerial application methods (drift fraction = 0.05), and that the 

solubility is greater than 100 mgL (solubility fraction=0.05). 

Sheet runoff 

Channelized Runoff 

* For aerial applications the EEC = application rate x 0.05; for ground applications the EEC = application rate x 0.01. 

EEC = Sheet Runoff +Drift 

EEC = Channelized Runoff + Drift 

Data Requirement Tables 

0.088 

Unincorporated; 

0.16 lb a.i./A 

Proposed New Uses 

835.2120 Hydrolysis 46904405, Acceptable 

46904426 no 

0.008 0.016 

835.2240 

835.2410 

Aerial Spray Application, 0.08 

Unincorporated; 

835.2370 

I Anaerobic Soil 

Metabolism 

0.008 

Photodegradation in 

Water 

Photodegradation on Soil 

835.4100 

. I Acceptable 1 46904410 

Photodegradation in Air 

46904406* 

46904503, 

Aerobic Soil Metabolism 

47576502 

No Data 

835.4400 

835.4300 

Acceptable 

Supplemental 

46904408, 

46904409, 

46904428 

no 

Waived** 

Anaerobic Aquatic 

Metabolism 

Aerobic Aquatic 

Metabolism 

no 

no 

Acceptable 

no 

469044 1 1 

469044 12 

Acceptable 

Acceptable 

no 

no 
Test Substantee 

Av~an Reproduct~on 

to BY1 08330 In 

Leaching-Adsorption1 

835 1410 

835.8100 

835.6100 

835.6200 

835.6300 

850.1730 

*An additional study with no MRID; **Waived based on low vapor pressure and Henry's law constant; ***Waived based on low 

octanoll water partition coefficient 

Laboratory Volatility 

Field Volatility 

Terrestrial Field 

Dissipation 

Aquatic Field 

Dissipation 

Forestry Dissipation 

Accumulation in Fish 

46904425, 

46904432, 

46904433 

No Data 

No Data 

4690442 1, 

46904422, 

46904423, 

46904424, 

469044 17 

No Data 

No Data 

No Data 

Waivedf* 

Waived** 

Acceptable 

NIA 

N/A 

Waived*** 

no 

no 

no 

no 

no 

no 
81-1 Acute Mammalian 

870.1 100 Oral LDSO 

TEP (OD 150) 46904576 

TEP (SC 240) 46904585 

Spirotetramat-ketohydroxy 46904593 

Spirotetetramat-di-hyroxy 46904598 

Mammalian I TGAI 1 46904546 1 NO I 

Acute Freshwater Fish 

72-1 

l CrAl 

TG A1 

TGAI Acute Freshwater Fish 717- -- --- Yes 

850.1075 

72-4 

850.1400 

1 46904439 

Dorgerloh, 

2004b 1 l CrAl 

TG A1 

TGAI 

Spirotetramat-ketohydroxy 

Water-only exposure 

Methoxycyclohexylamino carboxylic 

No data submitted 

850.1075 

72-4 

850.1400 

Lcso 

Freshwater Fish Early 

Life-Stage 

46904439 

Dorgerloh, 

2004b 

Lcso 

Freshwater 1 

Life-S 

TEP (OD 150) 

TEP (SC 240) 

Spirotetramat-en01 

TG A1 

Yes I I 

TI 

Spirotetramat-en01 

46904460 

46904468 

46904475 

46904442 No 

1 

I 

1 

I 

I I 
No data submitted 

No data submitted 

No data submitted 
TGAI 46904449 

144-1 Acute Honeybee TEP (SC 240) 46904469 No 

Contact and Oral TEP (OD 150) 46904461 

850.3020 Toxicity Test 

141-2 I Residues on Foliage 

Honev Bee Toxicity I No data submitted 

850.3030 Test I I 

Spirotetramat-4-methoxy- Earthworm Sub- 47319101 No 

850.6200 chronic Toxicity cyclohexanone 

Earthworm Acute TGAI 46904455 Non-guideline 46904472 No 

Toxicity Spirotetramat-ketohydroxy 

Earthworm Growth Moser & 

and Reproductive Spirotetramat-enol Scheffczyk, No Non-guideline 

Toxicity 2005 

48-hour Contact of 

Parasitoid Wasps with Waltersdorfer, TEP (OD 150) No 

Non-guideline Dried Residues on 2005a 

Treated Glass Plates 

7-day Contact of 

Predatory Mite with TEP (OD 150) Waltersdorfer, 

2005b No 

Nan-guideline Dried Residues on 

Treated Glass Plates 

48-hour Contact of 

Parasitoid Wasp with Waltersdorfer, TEP (OD 150) No 

Non-guideline Dried Residues on 2006a 

Treated Barley Plants 

7-day Contact of 

Predatory Mite with Waltersdorfer, TEP (OD 150) No 

~on-~uidkline Dried Residues on 2005c 

Treated Bean Leaves 

7-day Contact of 

Predatory Mite with Waltersdorfer, 

Dried Residues (acute TEP (OD 150) No 2006c Non-guideline and aged on treated 

I apple leaves) I 

1 Exvosure Until I 1 upa at ion of Green I acew win^ with Dried I Residues on Treated I TEP (OD 150) 

I Bean Leaves 

Exposure Until 1 

pupation Ladybird 

Beetle with Dried 

Non-guideline Residues on Treated 

Bean Leaves and 

TEP (OD 150) 

Roehlig, 2005 No 

Waltersdorfer, 

2006b No 

Aph~ds 

28-day Contact of Moser & 

Gamasld M~tes w~th Splrotetramat-en01 Scheffczyk, No 

Non-guldellne Contaminated So11 2005 

Ter&IWStrrdies 

I I 1 46904462 1 

TEP (OD 150) 47563302 Field Test for 

850.3040 47563303 In Reserve 

Pollinators 47563304 

Honey Bee Feeding TEP (OD 100) 46904458 Non-guideline 46904470 No 

Test TEP (SC 240) 
Brood Effects in 

TEP (OD 150)