UNITED STATES ENVmONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

PC-Code: 392201

OP Barcodes: 362953,363765,

358761

MEMORANDUM

Subject:

To:

From:

Through:

EFED Environmental Risk Assessment for the Proposed Uses of Spirotetramat on

the Production of Catton, Soybean, Legume Vegetables, Tropical Fruit, Pistachio,

Okra, and Dried Prunes, Review of Risk to Pollinators, and GrOlUldwater Label

Requirement Revision.

Rita Kumar, Risk Manager Reyiewer

John Hebert, Risk Manager, R.rn 07

Meredith Laws, Branch Chief

Insecticide·Rodenticide Branch

Registration Division (7505P) A/'

Joseph DeCant, Ecologist, Ecological Effects Reviewer ~//- "'~Y;l) Christina deMariano, Biologist, EcologicaJ Effects Reviewe~..-v-/~ M~@:J fiJi)

. Jtf~7k 7?"~ Jose L. Melendez, Chemist, Environmental Fate Reviewer:t (f

Environmental Risk Branch V

Environmental Fate and Effects Division (7507P)

MahT. Shamim, Ph.D., Branch Chief IJjJgj09

Environmental Risk Branch V

Environmental Fate and Effects Division (7 07 )

This memo addresses a series of requests made by Bayer CropScience related to the use of

spirotetramat. First. this memo assesses the state ofscience regarding pollinators and the results

of recently submitted studies as they pertain to the requested revisions to the bee label language

and 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). A list is attached of

endangered species that may be affected by the proposed uses (Appendix I).

The major conclusions from the assessment of available infonnation are as follows. The

Environmental Fate and Effects Division (EFED) does not concur with the request of B<lyer

1
Page 2 of 216 

CropScience 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 two field studies and the additional data contained in the submitted data package. The 

data gap therefore remains for OPPTS Guideline 850.3040; Field Testing for Pollinators. However, 

the EFED agrees with the registrant that the label statement, “Do not apply until after petal fall” 

in the specific crop sections for tree nuts, stone fruits, and pome fruits is redundant and is already 

stated in the “Application Information” section. The statement, “Do not apply until after petal 

fall”, may therefore be removed from the crop specific sections.

Regarding the groundwater label amendment, spirotetramat, spirotetramat-enol and/or 

spirotetramat-ketohydroxy, which are expected to be important components of spirotetramat total 

toxic residues, under particular conditions, are relatively highly mobile and persistent, and, under 

certain circumstances, as described in the label recommendation (“areas where soils are 

permeable, particularly where the water table is shallow”), could leach into ground waters. 

Based on these conclusions, the EFED does not concur with the registrant’s labels amendment 

request at this time. 

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. The ecological risk 

assessment findings under that review therefore pertain to this request (copy attached1). 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. 

Evaluation of Spirotetramat and Pollinators 

Request from Bayer CropScience 

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

degradates 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 

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

included in this data package. 

 

1

 Appendices can be found at H:\EFED_Chem_Files\392201\Sec 3\D345278. 

2

 MRID Numbers 47576401, 47563302, 47563303, 47563304, 47563305, 47563306, 47563307, 47563308, 

47563309, 47563310, 47563311, 47563312. 
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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 fall” 

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 

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

(MRID 472769-01), 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 
Page 4 of 216 

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 Recently 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). 

Classification: This field study is invalid due to the statistically significant differences between 

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

application as well as the inability to confirm exposure after 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./ha 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./ha treatment groups as compared to the control, respectively. 

Furthermore, 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
Page 5 of 216 

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 deltamethrin were used to control the infestation. 

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

through pollen/nectar analysis. 

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

colonies under a realistic field scenario in a melon crop.

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

spirotetramat on bees in a field scenario; however, the study did not confirm 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 quantify foraging on the 

crop. 

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 

pollen/nectar 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.

Classification: This study is supplemental because it shows the effects of spirotetramat on bee 

brood in a field 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 
Page 6 of 216 

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 1.0% 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 

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). 

Classification: 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 mg/kg. 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 spirotetramat 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 
Page 7 of 216 

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 BYI08330 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. 

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 mg/kg. 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 10mg BYI08330 and BYI08330-enol/kg 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. 
Page 8 of 216 

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 mg/kg after three hours post application in 

the 72 g a.i./ha treatment and 4.690 mg/kg 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 test) in Spain.

Classification: 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 mg/kg after an application of 288 g a.i./ha at 

17 days after treatment and 0.213 mg/kg 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. 

47563309 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.
Page 9 of 216 

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 0.591mg/kg. 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. 

Classification: 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 

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 mg/kg at 4 days after 

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

residues was 4.51 mg/kg 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 mg/kg 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. 

47563311 Residues of Spirotetramat and its metabolites in nectar and pollen of summer 

oilseed rape after spray application in Germany. 

Classification: 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. mellifera). The chemical was applied at 
Page 10 of 216 

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 mg/kg at 6 days after application. In addition, concentrations tended to remain high 

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

total residues in nectar showed much lower concentrations with a maximum of 0.06 mg/kg at 4 

days after application and an upper bound of 0.04 mg/kg 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. 

Classification: 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./ha/m 

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 mg/kg after a treatment of 288 g a.i./ha in melon and 

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

in the pollen stores of a hive up to a maximum of 0.306 mg/kg after a treatment of 288 g a.i./ha 

in melon, 6.35 mg/kg after a treatment of 100 g a.i./ha in phacelia, and 8.31 mg/kg 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 mg/kg. The NOAEC would therefore 
Page 11 of 216 

be 2 mg/kg 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 adverse 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 

mg/kg 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, 47563312), a lack of method reporting for toxicity endpoints 

(47563310, 47563311), a sampling design that may not have captured the maximum exposure 

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

pollen stored inside the hives were not be assessed in field study (47563304) even though one of 

the requested actions is to remove the restriction of applying spirotetramat 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 the labeling language related to both the application to 

blooming citrus or cucurbits and 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. 
Page 12 of 216 

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. Some aspects of the design 

that should be incorporated into a new field study should be: 

• An assessment of the maximum residues that would be collected in the pollen and nectar 

over the crop season 

• Confirm exposure in field trials with pollen identification and pollen and nectar residue 

analysis 

• Maintain an appropriate distance between the control and treatment plots 

• Extend the length of assessment time to assess impacts to overwintering brood 

• Ensure appropriate replication given the apparent variability in honey bee endpoints 

shown by the most recently submitted studies 

• Application rates should be the maximum labeled application rate and preferably the 

maximum seasonal rate as well 

• Report the methods for assessing all toxicity endpoints 

The EFED, however, concurs with the request to remove the statement “Do not apply until after 

petal fall” in the sections for pome fruits, stone fruits, and tree nuts. These statements are a 

reiteration of the label language in the “Application Information” that 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”. 

The EFED acknowledges the efforts of Bayer CropScience and looks forward to working with 

Bayer CropScience to further evaluate the effects of spirotetramat and its residues on pollinators. 

The efforts of Bayer CropScience in this evaluation are greatly appreciated as this study will 

provide needed data to address important information gaps in the risk assessment. 

Groundwater Label Requirement Revision3

Request from Bayer CropScience 

The registrant of spirotetramat, Bayer CropScience, also submitted applications to amend the 

labels of Spirotetramat Technical and its three end use products (as indicated in footnote #3). 

The registrant proposed to delete the following statements 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.” 

 

3

 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); ●BYI 8330 150 OD Insecticide (EPA Reg. No. 264-1051); ●ULTOR (EPA Reg. No. 264-

1065). 
Page 13 of 216 

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 is 

reviewing both submissions concurrently with this request. The issue of the NER is addressed in 

a separate document (refer to DP Barcode 358765+), and affects little the conclusions made in 

the current action. Based on a cursory revision of the available data, the Agency believes that 

the required statements should remain in the label. 

EFED Response 

EFED does not concur with the registrant’s labels amendment request at this time. According to 

the Label Review Manual,4

 “The need for a ground water label advisory is based on the 

environmental fate properties of the chemical and/or detections of the chemical in ground water.” 

The Agency requires a label statement based on its environmental fate characteristics like its 

mobility; firstly, if Kd is less than 5, or the field dissipation results indicate that the chemical 

leaches. For spirotetramat-ketohydroxy, which appears to be the most persistent of the 

compounds derived from spirotetramat, Kd ≤ 2.21 mL/g, indicating relatively high mobility (not 

to mention that for spirotetramat-enol, the range of Kd’s is as low as 0.52-0.86 mL/g, and for the 

parent spirotetramat itself, the Kd’s and KF’s are <5 mL/g as well). 

Secondly, the other characteristic examined is the chemical’s persistence; i.e., 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 hydrolysis of spirotetramat-ketohydroxy is uncertain (it is not available), but the 

spirotetramat-enol, which is the precursor of the ketohydroxy, is “stable” at pHs of 4, 7 and 9. 

Also, the parent spirotetramat shows half-lives of 32.5-47.6 days at pH 4 and a temperature of 

20-25oC. Spirotetramat-ketohydroxy is assumed to be stable to hydrolysis in the absence of 

additional information. Also, the aerobic soil metabolism of spirotetramat-ketohydroxy, ranges 

from 1.5 to 16.7 days, with a 90th percentile of the upper confidence bound on the mean of four 

half-life values of 12.4 days. Although for three of the soils, the half-lives were < 5 days, the 

value of 16.7 days (greater than 2 weeks) was obtained for the Molino sandy loam soil (from 

FL), with the lowest organic carbon content (0.93%) and the lowest microbial biomass (this is 

also the only domestic soil). This may indicate that in certain vulnerable soils, spirotetramatketohydroxy could persist (exhibit a half-life >2 weeks). As additional weight-of-evidence to 

support the conclusion that spirotetramat and/or its metabolites could be persistent under various 

conditions, in the aerobic aquatic environments, spirotetramat-ketohydroxy appears to be 

persistent (suggesting also that its hydrolysis is >30 days), and in anaerobic aquatic 

environments, the ultimate metabolite formed is spirotetramat-enol, which is persistent under the 

testing conditions (no data available for the ketohydroxy, but presumed to be persistent as well). 

 

4

 Available at the following url: http://www.epa.gov/oppfead1/labeling/lrm/ .
Page 14 of 216 

In short, spirotetramat, spirotetramat-enol and/or spirotetramat-ketohydroxy, which are expected 

to be important components of spirotetramat total toxic residues, under particular conditions, are 

relatively highly mobile and persistent, and, under certain circumstances, as described in the 

label recommendation (“areas where soils are permeable, particularly where the water table is 

shallow”), could leach into ground waters. Based on these conclusions, the EFED does not 

concur with the registrant’s labels amendment request at this time. 

Risk Assessment 

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

conducted with the EFED’s PRZM/EXAMS, 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 attached5

). 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. 

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

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

New uses are underlined and shaded gray. 

USE 

SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Cotton 0.08 2 0.16 7 G*, A 21 

Soybean 0.08 2 0.16 7 G*, A 21 

 5

 Appendices can be found at H:\EFED_Chem_Files\392201\Sec 3\D345278. 
Page 15 of 216 

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

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

New uses are underlined and shaded gray. 

USE 

SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Tropical Fruits (acerola, 

atemoya, avocado, birida, black 

sapote, canistel, cherimoya, 

custard apple, feijoa, jaboticaba, 

guava, llama, longan, lychee, 

mamey sapote, mango, papaya, 

passionfruit, persimmon, pulasan, 

rambutan, sapodilla, soursop, 

Spanish lime, star apple, starfruit, 

sugar apple, wax jambo, white 

sapote)

0.16 3 0.4 14 G*, A, 

Airblast 

1 

Legume Vegetables (except dry 

soybean) (succulent shelled pea 

and bean and dry shelled pea and 

bean) (including kidney bean, lima 

bean, navy bean, pinto bean, 

runner bean, snap bean, adzuki 

bean, blackeyed pea, chickpea, 

pigeon pea, soybean-immature 

seed) 

0.08 2 0.16 7 G*, A,

Chemigation

1 edible 

podded 

and succ 

beans 

and 

peas; 7 

dry 

shelled 

beans 

and peas 

Citrus Fruit (Crop Group 10, 

including calamondin, citrus citron, 

citrus hybrids like chironja, tangelo 

and tangor, grapefruit, kumquat, 

lemon, lime, mandarin or tangelo, 

sweet and sour orange, pummelo, 

Satsuma mandarin, and others)

0.16 2 0.32 21 G*, A, 

Airblast 

1 

Grape and Small Fruit Vine 

Climbing Crop Subgroup 13-07F 

(except Fuzzy kiwifruit/ includes 

grape, Gooseberry, Maypop, 

Schisandra berry)

0.12 2 0.2 30 G*, A, 

Airblast 

7 

Pome Fruit (Crop Group 11, 

including apple, crabapple, loquat, 

mayhaw, pear, oriental pear, quince)

0.14 3 0.4 7 G*, A, 

Airblast 

7 

Stone Fruit (Crop Group 12, 

including apricot, sweet and tart 

cherry, nectarine, peach, plumvarious kinds, plumcot and fresh and 

dried prune)

0.14 2 0.24 14 G*, A, 

Airblast 

7 

Tree Nuts (Crop Group 14 plus 

pistachio, including almond, 

beechnut, Brazil nut, butternut, 

cashew, chestnut, chinquapin, filberthazelnut, hickory nut, macadamia 

nut-bush nut, pecan, pistachio, 

walnut-black and English)

0.14 3 0.34 14 G*, A, 

Airblast 

7 
Page 16 of 216 

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

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

New uses are underlined and shaded gray. 

USE 

SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Hops 0.10 2 0.2 14 G*, A, 

Airblast 

7 

Christmas Trees 0.16 2 0.32 14 G*, A, 

Airblast 

N/A 

Cucurbit Vegetables [Crop Group 

9, including 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)] 

0.08 2 0.16 7 G, A, 

Chemigation

1 

Fruiting Vegetables (Crop Group 8 

plus okra including eggplant, 

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

0.08 2 0.16 7 G, A, 

Chemigation

1 

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 2 0.16 7 G, A, 

Chemigation

3 

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 2 0.16 7 G, A, 

Chemigation

1 
Page 17 of 216 

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

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

New uses are underlined and shaded gray. 

USE 

SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Potato and Other Tuberous and 

Corm Vegetables (Crop Subgroup 

1C including arracacha, arrowroot, 

artichoke-Chinese and Jerusalem, 

edible canna, bitter and sweet 

cassava, chayote-root, chufa, 

dasheen-taro, ginger, leren, potato, 

sweetpotato, tanier, turmeric, yam 

bean, true yam)

0.08 2 0.16 7 G, A, 

Chemigation

7 
Page 18 of 216 

Table 2. Estimated exposure concentrations (EECs) of spirotetramat plus degradates of concern (spirotetramat-enol 

and spirotetramat-ketohydroxy) (ppb) in the water column and the highest resultant RQs for aquatic animals. 

Maximum Modeled Exposure Scenario

Considered a 

(Crop Scenario; Max. Annual App. Rate; # 

Apps; App Int.) 

Peak 

EEC 

21-day 

EEC 

60-day 

EEC 

Highest 

Acute RQ b

Highest 

Chronic RQ c

Currently Registered Uses 

(NC apples aerial; 0.4; 3; 7) 11.4 11.1 10.8 0.0173 0.0202 

Proposed New Usesd 

(FL avocado aerial/ 

0.12+0.12+0.14/ 3/ 14) 

4.89 4.84 4.78 0.0074 0.0089 

a

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

highest EECs. Application rate in lb a.i./A and interval between applications in days. b Highest calculated acute RQs are for freshwater invertebrates. Toxicity values are based on studies with midges 

(Chironomus riparius) for freshwater invertebrates (EC50 = 660 μg 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 (0.1), and acute endangered species (0.05) 

LOCs. 

c

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

(Pimephales promelas) for freshwater fish (NOAEC = 534 μg 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. 

d

 Includes non-extracted residues in the EECs. 

Table 3. Estimated exposure concentrations of spirotetramat plus degradates of concern (spirotetramat-enol and 

spirotetramat-ketohydroxy) (ppb) in the water column and the highest resultant RQs for aquatic plants. 

Maximum Modeled Exposure Scenario

Considered a

(Crop Scenario; Max. Annual App. Rate; # 

Apps; App Int.) Peak 

EEC 

Non-endangered Endangered 

Nonvascular 

Plants RQ b

Vascular 

Plants RQ b

Nonvascular 

Plants RQ b

Vascular 

Plants RQ b

Currently Registered Uses 

 (NC apples aerial; 0.4; 3; 7) 11.4 0.0317 0.0025 0.0919 0.0074 

Proposed New Usesc 

(FL avocado aerial/ 

0.12+0.12+0.14/ 3/ 14) 

4.89 0.0136 0.001 0.0394 0.0032 

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

highest EECs. Application rate in lb a.i./A and interval between applications in days. b Toxicity values are based on studies with duckweed (Lemna gibba) for vascular plants (EC50 = 4620 μg a.i./L; 

NOAEC=1540 μg a.i./L) and marine diatoms (Skeletonema costatum) for non-vascular plants (EC50 = 360 μg a.i./L; 

NOAEC=124 μg a.i./L). EC50 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 from 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. 

c

 Includes non-extracted residues in the EECs. 
Page 19 of 216 

Table 4. Input parameters and upper-bound estimated environmental concentrations (EECs; in mg/kg-diet) of 

total spirotetramat (parent + degradates) residues generated for the maximum spirotetramat exposure scenarios 

considered for the currently registered and the proposed new uses using T-REX v1.3.1. 

Max. Single App. Rate 

(lbs a.i./A) 

Min. 

Interval 

(Days) 

Max. No. 

Apps. 

Per Year 

Upper-bound EECs in mg/kg-diet 

Short Grass Long Grass 

Broadleaf 

Plants, 

Small 

Insects 

Fruits, 

Pods, 

Seeds, 

Large 

Insects 

Currently Registered Uses 

0.14 7 3 52.44 24.03 29.50 3.28 

Proposed New Uses 

0.16 14 3 45.54 20.87 25.62 2.85 

Table 5. Estimated environmental concentrations (EECs; in lb a.i./A) of total spirotetramat (parent + degradates) 

residues on plants following the maximum exposure scenario considered for the currently registered and the 

proposed new uses using the TerrPlant model. a

EECs 

Application Method; Rate Runoff to 

Dry Areas b 

Runoff to 

Semi-aquatic 

Areas c 

Drift d Total Loading 

to Dry Areas e 

Total Loading to 

Semi-aquatic Areas 

f

Currently Registered Uses

Aerial Spray Application, 

Unincorporated; 

0.16 lb a.i./A 

0.008 0.08 0.008 0.016 0.088 

Proposed New Uses

Aerial Spray Application, 

Unincorporated; 

0.16 lb a.i./A 

0.008 0.08 0.008 0.016 0.088 

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 mg/L (solubility fraction=0.05). b Sheet runoff 

c

 Channelized Runoff 

d

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

 EEC = Sheet Runoff +Drift 

f

 EEC = Channelized Runoff + Drift
Page 20 of 216 

Appendix I : List of Endangered Species 

Species Listing by State with Use Criteria 

No species were excluded

 Minimum of 1 Acre.

All Medium Types Reported

Mammal, Marine mml, Bird, Amphibian, Reptile, Fish, Crustacean, Bivalve, 

Gastropod, Arachnid, Insect, Dicot, Monocot, Ferns, Conf/cycds, Coral, Lichen

cotton - all, soybeans for beans, bean - yard long, beans - dry (PR), beans - dry edible, 

excluding limas, beans - dry edible, excluding limas (irrigated), beans - green (PR, VI), 

beans - snap, guar, guar (irrigated), lentils, lentils (irrigated), lima beans - dry, lima beans - 

dry (irrigated), lima beans - green, mungbeans for beans, mungbeans for beans (irrigated), 

peas - austrian winter, peas - austrian winter (irrigated), peas - chinese (sugar and snow), 

peas - dry edible, peas - dry edible (irrigated), peas - dry southern (cowpeas), peas - dry 

southern (cowpeas) (irrigated), peas - green (excluding southern), peas - green southern 

(cowpeas) - blackeyed, crowder, etc., pigeon peas (PR), pistachios, okra, avocados, 

avocados (PR), balsam pear, bananas, bananas (PR), breadfruit, citron (PR), citrus fruit, 

all, citrus fruit, other, coconuts, fruits - other (PR), fruits and coconuts (PR), gado, 

grapefruit, grapefruit (PR, VI), guavas, k-early citrus, kiwifruit, kumquats, lemons, lemons

 and limes, limes, mangoes, mangoes (PR), muskmelons and pepinos, nectarines, oranges -

 all, oranges - other, oranges - valencia, oranges (PR), papayas, papayas (PR, VI), passion 

fruit, pineapples, pineapples harvested, pineapples not harvested, plantains (PR, VI), 

pomegranates, soursops, tangelos, tangerines, taro, temples, yams, plums and prunes 

Alabama ( 91) species: Taxa Critical Habitat

Salamander, Flatwoods T Amphibian No

(Ambystoma cingulatum) Terrestrial, Freshwater, Vernal pool

Salamander, Red Hills T Amphibian No

(Phaeognathus hubrichti) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Combshell, Southern (=Penitent mussel) E Bivalve No

(Epioblasma penita) Freshwater

Combshell, Upland E Bivalve Yes

(Epioblasma metastriata) Freshwater

Kidneyshell, Triangular E Bivalve Yes

(Ptychobranchus greenii) Freshwater

Mucket, Orangenacre T Bivalve Yes

(Lampsilis perovalis) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Acornshell Southern E Bivalve Yes

(Epioblasma othcaloogensis) Freshwater

Mussel, Alabama Moccasinshell T Bivalve Yes

(Medionidus acutissimus) Freshwater

Mussel, Coosa Moccasinshell E Bivalve Yes

(Medionidus parvulus) Freshwater

Mussel, Cumberland Combshell E Bivalve Yes
Page 21 of 216 

(Epioblasma brevidens) Freshwater

Mussel, Dark Pigtoe E Bivalve Yes

(Pleurobema furvum) Freshwater

Mussel, Fine-lined Pocketbook T Bivalve Yes

(Lampsilis altilis) Freshwater

Mussel, Fine-rayed Pigtoe E Bivalve No

(Fusconaia cuneolus) Freshwater

Mussel, Flat Pigtoe (=Marshall's Mussel) E Bivalve No

(Pleurobema marshalli) Freshwater

Mussel, Heavy Pigtoe (=Judge Tait's Mussel) E Bivalve No

(Pleurobema taitianum) Freshwater

Mussel, Heelsplitter Inflated T Bivalve No

(Potamilus inflatus) Freshwater

Mussel, Ovate Clubshell E Bivalve Yes

(Pleurobema perovatum) Freshwater

Mussel, Ring Pink (=Golf Stick Pearly) E Bivalve No

(Obovaria retusa) Freshwater

Mussel, Rough Pigtoe E Bivalve No

(Pleurobema plenum) Freshwater

Mussel, Shiny Pigtoe E Bivalve No

(Fusconaia cor) Freshwater

Mussel, Shiny-rayed Pocketbook E Bivalve No

(Lampsilis subangulata) Freshwater

Mussel, Southern Clubshell E Bivalve Yes

(Pleurobema decisum) Freshwater

Mussel, Southern Pigtoe E Bivalve Yes

(Pleurobema georgianum) Freshwater

Pearlymussel, Alabama Lamp E Bivalve No

(Lampsilis virescens) Freshwater

Pearlymussel, Cracking E Bivalve No

(Hemistena lata) Freshwater

Pearlymussel, Cumberland Monkeyface E Bivalve No

(Quadrula intermedia) Freshwater

Pearlymussel, Orange-footed E Bivalve No

(Plethobasus cooperianus) Freshwater

Pearlymussel, Pale Lilliput E Bivalve No

(Toxolasma cylindrellus) Freshwater

Pearlymussel, Turgid-blossom E Bivalve No

(Epioblasma turgidula) Freshwater

Pearlymussel, White Wartyback E Bivalve No

(Plethobasus cicatricosus) Freshwater

Stirrupshell E Bivalve No

(Quadrula stapes) Freshwater

Shrimp, Alabama Cave E Crustacean No

(Palaemonias alabamae) Freshwater

Amphianthus, Little T Dicot No

(Amphianthus pusillus) Freshwater

Barbara Buttons, Mohr's T Dicot No

(Marshallia mohrii) Terrestrial

Bladderpod, Lyrate T Dicot No

(Lesquerella lyrata) Terrestrial

Clover, Leafy Prairie E Dicot No
Page 22 of 216 

(Dalea foliosa) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Leather-flower, Alabama E Dicot No

(Clematis socialis) Terrestrial

Leather-flower, Morefield's E Dicot No

(Clematis morefieldii) Terrestrial

Pitcher-plant, Alabama Canebrake E Dicot No

(Sarracenia rubra alabamensis) Terrestrial, Freshwater

Pitcher-plant, Green E Dicot No

(Sarracenia oreophila) Terrestrial, Freshwater

Potato-bean, Price's T Dicot No

(Apios priceana) Terrestrial

Fern, Alabama Streak-sorus T Ferns No

(Thelypteris pilosa var. alabamensis) Terrestrial

Fern, American hart's-tongue T Ferns No

(Asplenium scolopendrium var. americanum) Terrestrial

Quillwort, Louisiana E Ferns No

(Isoetes louisianensis) Terrestrial, Freshwater

Cavefish, Alabama E Fish Yes

(Speoplatyrhinus poulsoni) Freshwater

Chub, Spotfin T Fish Yes

(Erimonax monachus) Freshwater

Darter, Boulder E Fish No

(Etheostoma wapiti) Freshwater

Darter, Goldline T Fish No

(Percina aurolineata) Freshwater

Darter, Slackwater T Fish Yes

(Etheostoma boschungi) Freshwater

Darter, Snail T Fish No

(Percina tanasi) Freshwater

Darter, Vermilion E Fish No

(Etheostoma chermocki) Freshwater

Darter, Watercress E Fish No

(Etheostoma nuchale) Freshwater

Madtom, Yellowfin T Fish Yes

(Noturus flavipinnis) Freshwater

Sculpin, Pygmy T Fish No

(Cottus paulus (=pygmaeus)) Freshwater

Shiner, Blue T Fish No

(Cyprinella caerulea) Freshwater

Shiner, Cahaba E Fish No

(Notropis cahabae) Freshwater

Shiner, Palezone E Fish No

(Notropis albizonatus) Freshwater

Sturgeon, Alabama E Fish No

(Scaphirhynchus suttkusi) Freshwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Campeloma, Slender E Gastropod No

(Campeloma decampi) Freshwater

Elimia, Lacy T Gastropod No
Page 23 of 216 

(Elimia crenatella) Freshwater

Pebblesnail, Flat E Gastropod No

(Lepyrium showalteri) Freshwater

Riversnail, Anthony's E Gastropod No

(Athearnia anthonyi) Freshwater

Rocksnail, Painted T Gastropod No

(Leptoxis taeniata) Freshwater

Rocksnail, Plicate E Gastropod No

(Leptoxis plicata) Freshwater

Rocksnail, Round T Gastropod No

(Leptoxis ampla) Freshwater

Snail, Armored E Gastropod No

(Pyrgulopsis (=Marstonia) pachyta) Freshwater

Snail, Lioplax Cylindrical E Gastropod No

(Lioplax cyclostomaformis) Freshwater

Snail, Tulotoma E Gastropod No

(Tulotoma magnifica) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Mouse, Alabama Beach E Mammal Yes

(Peromyscus polionotus ammobates) Terrestrial, Coastal

Mouse, Perdido Key Beach E Mammal Yes

(Peromyscus polionotus trissyllepsis) Coastal

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Grass, Tennessee Yellow-eyed E Monocot No

(Xyris tennesseensis) Terrestrial

Trillium, Relict E Monocot No

(Trillium reliquum) Terrestrial

Water-plantain, Kral's T Monocot No

(Sagittaria secundifolia) Freshwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Snake, Eastern Indigo T Reptile Yes

(Drymarchon corais couperi) Terrestrial

Tortoise, Gopher T Reptile No

(Gopherus polyphemus) Terrestrial

Turtle, Alabama Red-bellied E Reptile No

(Pseudemys alabamensis) Terrestrial, Freshwater

Turtle, Flattened Musk T Reptile No

(Sternotherus depressus) Terrestrial, Freshwater

Arizona ( 55) species: Taxa Critical Habitat
Page 24 of 216 

Frog, Chiricahua Leopard T Amphibian No

(Rana chiricahuensis) Terrestrial, Freshwater

Salamander, Sonora Tiger E Amphibian No

(Ambystoma tigrinum stebbinsi) Terrestrial, Freshwater, Vernal pool

Bobwhite, Masked E Bird No

(Colinus virginianus ridgwayi) Terrestrial

Eagle, Bald T Bird No

(Haliaeetus leucocephalus) Terrestrial

Falcon, Northern Aplomado E Bird No

(Falco femoralis septentrionalis) Terrestrial

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Owl, Mexican Spotted T Bird Yes

(Strix occidentalis lucida) Terrestrial

Rail, Yuma Clapper E Bird No

(Rallus longirostris yumanensis) Terrestrial

Blue-star, Kearney's E Dicot No

(Amsonia kearneyana) Terrestrial

Cactus, Arizona Hedgehog E Dicot No

(Echinocereus triglochidiatus var. arizonicus) Terrestrial

Cactus, Brady Pincushion E Dicot No

(Pediocactus bradyi) Terrestrial

Cactus, Cochise Pincushion T Dicot No

(Coryphantha robbinsorum) Terrestrial

Cactus, Nichol's Turk's Head E Dicot No

(Echinocactus horizonthalonius var. nicholii) Terrestrial

Cactus, Pima Pineapple E Dicot No

(Coryphantha scheeri var. robustispina) Terrestrial

Cactus, Siler Pincushion T Dicot No

(Pediocactus (=Echinocactus,=Utahia) sileri) Terrestrial

Cliffrose, Arizona E Dicot No

(Purshia (=cowania) subintegra) Terrestrial

Cycladenia, Jones T Dicot No

(Cycladenia jonesii (=humilis)) Terrestrial

Fleabane, Zuni T Dicot No

(Erigeron rhizomatus) Terrestrial

Groundsel, San Francisco Peaks T Dicot Yes

(Senecio franciscanus) Terrestrial

Milk-vetch, Holmgren E Dicot No

(Astragalus holmgreniorum) Terrestrial

Milk-vetch, Sentry E Dicot No

(Astragalus cremnophylax var. cremnophylax) Terrestrial

Milkweed, Welsh's T Dicot Yes

(Asclepias welshii) Terrestrial

Umbel, Huachuca Water E Dicot Yes

(Lilaeopsis schaffneriana var. recurva) Terrestrial, Freshwater

Catfish, Yaqui T Fish Yes

(Ictalurus pricei) Freshwater

Chub, Bonytail E Fish Yes

(Gila elegans) Freshwater

Chub, Gila E Fish Yes

(Gila intermedia) Freshwater
Page 25 of 216 

Chub, Humpback E Fish Yes

(Gila cypha) Freshwater

Chub, Sonora T Fish Yes

(Gila ditaenia) Freshwater

Chub, Virgin River E Fish Yes

(Gila seminuda (=robusta)) Freshwater

Chub, Yaqui E Fish Yes

(Gila purpurea) Freshwater

Minnow, Loach T Fish Yes

(Tiaroga cobitis) Freshwater

Pupfish, Desert E Fish Yes

(Cyprinodon macularius) Freshwater

Shiner, Beautiful T Fish Yes

(Cyprinella formosa) Freshwater

Spikedace T Fish Yes

(Meda fulgida) Freshwater

Spinedace, Little Colorado T Fish Yes

(Lepidomeda vittata) Freshwater

Squawfish, Colorado E Fish Yes

(Ptychocheilus lucius) Freshwater

Steelhead E Fish Yes

(Oncorhynchus (=Salmo) mykiss) Freshwater, Brackish, Saltwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Topminnow, Gila (Yaqui) E Fish No

(Poeciliopsis occidentalis) Freshwater

Trout, Apache T Fish No

(Oncorhynchus apache) Freshwater

Trout, Gila E Fish No

(Oncorhynchus gilae) Freshwater

Woundfin E Fish Yes

(Plagopterus argentissimus) Freshwater

Ambersnail, Kanab E Gastropod No

(Oxyloma haydeni kanabensis) Terrestrial, Freshwater

Bat, Lesser (=Sanborn's) Long-nosed E Mammal No

(Leptonycteris curasoae yerbabuenae) Terrestrial, Subterraneous

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Jaguar E Mammal No

(Panthera onca) Terrestrial

Jaguarundi, Sinaloan E Mammal No

(Herpailurus (=Felis) yagouaroundi tolteca) Terrestrial

Ocelot E Mammal No

(Leopardus (=Felis) pardalis) Terrestrial

Pronghorn, Sonoran E Mammal No

(Antilocapra americana sonoriensis) Terrestrial

Squirrel, Mount Graham Red E Mammal Yes

(Tamiasciurus hudsonicus grahamensis) Terrestrial

Vole, Hualapai Mexican E Mammal No

(Microtus mexicanus hualpaiensis) Terrestrial

Ladies'-tresses, Canelo Hills E Monocot No

(Spiranthes delitescens) Terrestrial
Page 26 of 216 

Sedge, Navajo T Monocot Yes

(Carex specuicola) Terrestrial

Rattlesnake, New Mexican Ridge-nosed T Reptile Yes

(Crotalus willardi obscurus) Terrestrial

Tortoise, Desert T Reptile Yes

(Gopherus agassizii) Terrestrial

Arkansas ( 20) species: Taxa Critical Habitat

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Fatmucket, Arkansas T Bivalve No

(Lampsilis powelli) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Scaleshell E Bivalve No

(Leptodea leptodon) Freshwater

Mussel, Speckled Pocketbook E Bivalve No

(Lampsilis streckeri) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Rock-pocketbook, Ouachita (=Wheeler's pm) E Bivalve No

(Arkansia wheeleri) Freshwater

Crayfish, Cave (Cambarus aculabrum) E Crustacean No

(Cambarus aculabrum) Freshwater

Bladderpod, Missouri T Dicot No

(Lesquerella filiformis) Terrestrial

Fruit, Earth (=geocarpon) T Dicot No

(Geocarpon minimum) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Cavefish, Ozark T Fish No

(Amblyopsis rosae) Freshwater

Darter, Leopard T Fish Yes

(Percina pantherina) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Shagreen, Magazine Mountain T Gastropod No

(Mesodon magazinensis) Terrestrial

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Ozark Big-eared E Mammal No

(Corynorhinus (=Plecotus) townsendii ingens) Terrestrial, Subterraneous

California ( 284) species: Taxa Critical Habitat

Frog, California Red-legged T Amphibian Yes

(Rana aurora draytonii) Terrestrial, Freshwater

Frog, Mountain Yellow-legged E Amphibian No

(Rana muscosa) Terrestrial, Freshwater
Page 27 of 216 

Salamander, California Tiger E Amphibian No

(Ambystoma californiense) Terrestrial, Vernal pool

Salamander, Desert Slender E Amphibian No

(Batrachoseps aridus) Terrestrial, Freshwater

Salamander, Santa Cruz Long-toed E Amphibian No

(Ambystoma macrodactylum croceum) Terrestrial, Freshwater, Vernal pool

Toad, Arroyo Southwestern E Amphibian Yes

(Bufo californicus (=microscaphus)) Terrestrial, Freshwater

Condor, California E Bird Yes

(Gymnogyps californianus) Terrestrial

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Gnatcatcher, Coastal California T Bird Yes

(Polioptila californica californica) Terrestrial

Murrelet, Marbled T Bird Yes

(Brachyramphus marmoratus) Terrestrial, Freshwater, Saltwater

Owl, Northern Spotted T Bird Yes

(Strix occidentalis caurina) Terrestrial

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Plover, Western Snowy T Bird Yes

(Charadrius alexandrinus nivosus) Terrestrial

Rail, California Clapper E Bird No

(Rallus longirostris obsoletus) Terrestrial

Rail, Light-footed Clapper E Bird No

(Rallus longirostris levipes) Terrestrial

Rail, Yuma Clapper E Bird No

(Rallus longirostris yumanensis) Terrestrial

Shrike, San Clemente Loggerhead E Bird No

(Lanius ludovicianus mearnsi) Terrestrial

Sparrow, San Clemente Sage T Bird No

(Amphispiza belli clementeae) Terrestrial

Tern, California Least E Bird No

(Sterna antillarum browni) Terrestrial

Vireo, Least Bell's E Bird Yes

(Vireo bellii pusillus) Terrestrial

Cypress, Gowen T Conf/cycds No

(Cupressus goveniana ssp. goveniana) Terrestrial

Cypress, Santa Cruz E Conf/cycds No

(Cupressus abramsiana) Terrestrial

Crayfish, Shasta E Crustacean No

(Pacifastacus fortis) Freshwater

Fairy Shrimp, Conservancy Fairy E Crustacean Yes

(Branchinecta conservatio) Vernal pool

Fairy Shrimp, Longhorn E Crustacean Yes

(Branchinecta longiantenna) Vernal pool

Fairy Shrimp, Riverside E Crustacean Yes

(Streptocephalus woottoni) Vernal pool

Fairy Shrimp, San Diego E Crustacean Yes

(Branchinecta sandiegonensis) Vernal pool

Fairy Shrimp, Vernal Pool T Crustacean Yes

(Branchinecta lynchi) Vernal pool
Page 28 of 216 

Shrimp, California Freshwater E Crustacean No

(Syncaris pacifica) Freshwater

Tadpole Shrimp, Vernal Pool E Crustacean Yes

(Lepidurus packardi) Vernal pool

Adobe Sunburst, San Joaquin T Dicot No

(Pseudobahia peirsonii) Terrestrial

Allocarya, Calistoga E Dicot No

(Plagiobothrys strictus) Vernal pool

Ambrosia, San Diego E Dicot No

(Ambrosia pumila) Terrestrial

Baccharis, Encinitas T Dicot No

(Baccharis vanessae) Terrestrial

Barberry, Island E Dicot No

(Berberis pinnata ssp. insularis) Terrestrial

Barberry, Nevin's E Dicot No

(Berberis nevinii) Terrestrial

Bedstraw, El Dorado E Dicot No

(Galium californicum ssp. sierrae) Terrestrial

Bedstraw, Island E Dicot No

(Galium buxifolium) Terrestrial

Bird's-beak, Palmate-bracted E Dicot No

(Cordylanthus palmatus) Terrestrial

Bird's-beak, Pennell's E Dicot No

(Cordylanthus tenuis ssp. capillaris) Terrestrial

Bird's-beak, salt marsh E Dicot No

(Cordylanthus maritimus ssp. maritimus) Saltwater

Bird's-beak, Soft E Dicot No

(Cordylanthus mollis ssp. mollis) Brackish, Saltwater

Bladderpod, San Bernardino Mountains E Dicot Yes

(Lesquerella kingii ssp. bernardina) Terrestrial

Bluecurls, Hidden Lake T Dicot No

(Trichostema austromontanum ssp. compactum) Terrestrial

Broom, San Clemente Island E Dicot No

(Lotus dendroideus ssp. traskiae) Terrestrial

Buckwheat, Cushenbury E Dicot Yes

(Eriogonum ovalifolium var. vineum) Terrestrial

Buckwheat, Ione (incl. Irish Hill) E Dicot No

(Eriogonum apricum (incl. var. prostratum)) Terrestrial

Buckwheat, Southern Mountain Wild T Dicot Yes

(Eriogonum kennedyi var. austromontanum) Terrestrial

Bush-mallow, San Clemente Island E Dicot No

(Malacothamnus clementinus) Terrestrial

Bush-mallow, Santa Cruz Island E Dicot No

(Malacothamnus fasciculatus var. nesioticus) Terrestrial

Butterweed, Layne's T Dicot No

(Senecio layneae) Terrestrial

Button-celery, San Diego E Dicot No

(Eryngium aristulatum var. parishii) Terrestrial

Cactus, Bakersfield E Dicot No

(Opuntia treleasei) Terrestrial

Ceanothus, Coyote E Dicot No

(Ceanothus ferrisae) Terrestrial
Page 29 of 216 

Ceanothus, Pine Hill E Dicot No

(Ceanothus roderickii) Terrestrial

Ceanothus, Vail Lake T Dicot Yes

(Ceanothus ophiochilus) Terrestrial

Checker-mallow, Keck's E Dicot Yes

(Sidalcea keckii) Terrestrial

Checker-mallow, Kenwood Marsh E Dicot No

(Sidalcea oregana ssp. valida) Terrestrial

Checker-mallow, Pedate E Dicot No

(Sidalcea pedata) Terrestrial

Clarkia, Pismo E Dicot No

(Clarkia speciosa ssp. immaculata) Terrestrial

Clarkia, Presidio E Dicot No

(Clarkia franciscana) Terrestrial

Clarkia, Springville T Dicot No

(Clarkia springvillensis) Terrestrial

Clarkia, Vine Hill E Dicot No

(Clarkia imbricata) Terrestrial

Clover, Fleshy Owl's T Dicot Yes

(Castilleja campestris ssp. succulenta) Vernal pool

Clover, Monterey E Dicot No

(Trifolium trichocalyx) Terrestrial

Clover, Showy Indian E Dicot No

(Trifolium amoenum) Terrestrial

Coyote-thistle, Loch Lomond E Dicot No

(Eryngium constancei) Terrestrial

Crownbeard, Big-leaved T Dicot No

(Verbesina dissita) Terrestrial

Crownscale, San Jacinto Valley E Dicot No

(Atriplex coronata var. notatior) Terrestrial

Daisy, Parish's T Dicot Yes

(Erigeron parishii) Freshwater

Dudleya, Conejo T Dicot No

(Dudleya abramsii ssp. parva) Terrestrial

Dudleya, Marcescent T Dicot No

(Dudleya cymosa ssp. marcescens) Terrestrial

Dudleya, Santa Clara Valley E Dicot No

(Dudleya setchellii) Terrestrial

Dudleya, Santa Cruz Island T Dicot No

(Dudleya nesiotica) Terrestrial

Dudleya, Santa Monica Mountains T Dicot No

(Dudleya cymosa ssp. ovatifolia) Terrestrial

Dudleya, Verity's T Dicot No

(Dudleya verityi) Terrestrial

Dwarf-flax, Marin T Dicot No

(Hesperolinon congestum) Terrestrial

Evening-primrose, Antioch Dunes E Dicot Yes

(Oenothera deltoides ssp. howellii) Terrestrial

Evening-primrose, San Benito T Dicot No

(Camissonia benitensis) Terrestrial

Fiddleneck, Large-flowered E Dicot Yes

(Amsinckia grandiflora) Terrestrial
Page 30 of 216 

Flannelbush, Mexican E Dicot Yes

(Fremontodendron mexicanum) Terrestrial

Flannelbush, Pine Hill E Dicot No

(Fremontodendron californicum ssp. decumbens) Terrestrial

Fringepod, Santa Cruz Island E Dicot No

(Thysanocarpus conchuliferus) Terrestrial

Gilia, Hoffmann's Slender-flowered E Dicot No

(Gilia tenuiflora ssp. hoffmannii) Terrestrial

Gilia, Monterey E Dicot No

(Gilia tenuiflora ssp. arenaria) Terrestrial

Golden Sunburst, Hartweg's E Dicot No

(Pseudobahia bahiifolia) Terrestrial

Goldfields, Burke's E Dicot No

(Lasthenia burkei) Terrestrial

Goldfields, Contra Costa E Dicot Yes

(Lasthenia conjugens) Terrestrial

Grass, Hairy Orcutt E Dicot Yes

(Orcuttia pilosa) Vernal pool

Grass, Sacramento Orcutt E Dicot Yes

(Orcuttia viscida) Vernal pool

Grass, Slender Orcutt T Dicot Yes

(Orcuttia tenuis) Vernal pool

Jewelflower, California E Dicot No

(Caulanthus californicus) Terrestrial

Jewelflower, Tiburon E Dicot No

(Streptanthus niger) Terrestrial

Larkspur, Baker's E Dicot Yes

(Delphinium bakeri) Terrestrial

Larkspur, San Clemente Island E Dicot No

(Delphinium variegatum ssp. kinkiense) Terrestrial

Larkspur, Yellow E Dicot Yes

(Delphinium luteum) Terrestrial

Layia, Beach E Dicot No

(Layia carnosa) Terrestrial, Coastal

Lessingia, San Francisco E Dicot No

(Lessingia germanorum (=L.g. var. germanorum)) Terrestrial

Liveforever, Laguna Beach T Dicot No

(Dudleya stolonifera) Terrestrial

Liveforever, Santa Barbara Island E Dicot No

(Dudleya traskiae) Terrestrial

Lupine, Clover E Dicot No

(Lupinus tidestromii) Coastal

Lupine, Nipomo Mesa E Dicot No

(Lupinus nipomensis) Coastal

Malacothrix, Island E Dicot No

(Malacothrix squalida) Terrestrial

Malacothrix, Santa Cruz Island E Dicot No

(Malacothrix indecora) Terrestrial

Mallow, Kern E Dicot No

(Eremalche kernensis) Terrestrial

Manzanita, Del Mar E Dicot No

(Arctostaphylos glandulosa ssp. crassifolia) Terrestrial
Page 31 of 216 

Manzanita, Ione T Dicot No

(Arctostaphylos myrtifolia) Terrestrial

Manzanita, Morro T Dicot No

(Arctostaphylos morroensis) Terrestrial

Manzanita, Pallid T Dicot No

(Arctostaphylos pallida) Terrestrial

Manzanita, Santa Rosa Island E Dicot No

(Arctostaphylos confertiflora) Terrestrial

Meadowfoam, Butte County E Dicot Yes

(Limnanthes floccosa ssp. californica) Vernal pool

Meadowfoam, Sebastopol E Dicot No

(Limnanthes vinculans) Terrestrial, Freshwater

Milk-vetch, Braunton's E Dicot No

(Astragalus brauntonii) Terrestrial

Milk-vetch, Clara Hunt's E Dicot No

(Astragalus clarianus) Terrestrial

Milk-vetch, Coachella Valley E Dicot Yes

(Astragalus lentiginosus var. coachellae) Terrestrial

Milk-vetch, Coastal Dunes E Dicot No

(Astragalus tener var. titi) Terrestrial

Milk-vetch, Cushenbury E Dicot Yes

(Astragalus albens) Terrestrial

Milk-vetch, Fish Slough T Dicot No

(Astragalus lentiginosus var. piscinensis) Terrestrial

Milk-vetch, Lane Mountain E Dicot Yes

(Astragalus jaegerianus) Terrestrial

Milk-vetch, Pierson's T Dicot Yes

(Astragalus magdalenae var. peirsonii) Terrestrial

Milk-vetch, Triple-ribbed E Dicot No

(Astragalus tricarinatus) Terrestrial

Milk-vetch, Ventura Marsh E Dicot Yes

(Astragalus pycnostachyus var. lanosissimus) Terrestrial, Freshwater

Mint, Otay Mesa E Dicot No

(Pogogyne nudiuscula) Terrestrial

Mint, San Diego Mesa E Dicot No

(Pogogyne abramsii) Terrestrial

Monardella, Willowy E Dicot No

(Monardella linoides ssp. viminea) Terrestrial

Morning-glory, Stebbins E Dicot No

(Calystegia stebbinsii) Terrestrial

Mountainbalm, Indian Knob E Dicot No

(Eriodictyon altissimum) Terrestrial

Mountain-mahogany, Catalina Island E Dicot No

(Cercocarpus traskiae) Terrestrial

Mustard, Slender-petaled E Dicot No

(Thelypodium stenopetalum) Terrestrial

Navarretia, Few-flowered E Dicot No

(Navarretia leucocephala ssp. Pauciflora) Terrestrial, Vernal pool

Navarretia, Many-flowered E Dicot No

(Navarretia leucocephala ssp. plieantha) Terrestrial, Vernal pool

Navarretia, Spreading T Dicot No

(Navarretia fossalis) Vernal pool
Page 32 of 216 

Oxytheca, Cushenbury E Dicot Yes

(Oxytheca parishii var. goodmaniana) Terrestrial

Paintbrush, Ash-grey Indian T Dicot Yes

(Castilleja cinerea) Terrestrial

Paintbrush, San Clemente Island Indian E Dicot No

(Castilleja grisea) Terrestrial

Paintbrush, Soft-leaved E Dicot No

(Castilleja mollis) Terrestrial

Paintbrush, Tiburon E Dicot No

(Castilleja affinis ssp. neglecta) Terrestrial

Penny-cress, Kneeland Prairie E Dicot Yes

(Thlaspi californicum) Terrestrial

Pentachaeta, Lyon's E Dicot No

(Pentachaeta lyonii) Terrestrial

Pentachaeta, White-rayed E Dicot No

(Pentachaeta bellidiflora) Terrestrial

Phacelia, Island E Dicot No

(Phacelia insularis ssp. insularis) Terrestrial

Phlox, Yreka E Dicot No

(Phlox hirsuta) Terrestrial

Polygonum, Scott's Valley E Dicot Yes

(Polygonum hickmanii) Terrestrial

Potentilla, Hickman's E Dicot No

(Potentilla hickmanii) Terrestrial

Pussypaws, Mariposa T Dicot No

(Calyptridium pulchellum) Terrestrial

Rock-cress, Hoffmann's E Dicot No

(Arabis hoffmannii) Terrestrial

Rock-cress, McDonald's E Dicot No

(Arabis mcdonaldiana) Terrestrial

Rock-cress, Santa Cruz Island E Dicot No

(Sibara filifolia) Terrestrial

Rush-rose, Island T Dicot No

(Helianthemum greenei) Terrestrial

Sandwort, Bear Valley T Dicot Yes

(Arenaria ursina) Terrestrial

Sandwort, Marsh E Dicot No

(Arenaria paludicola) Terrestrial, Freshwater

Sea-blite, California E Dicot No

(Suaeda californica) Terrestrial

Spineflower, Ben Lomond E Dicot No

(Chorizanthe pungens var. hartwegiana) Terrestrial

Spineflower, Howell's E Dicot No

(Chorizanthe howellii) Terrestrial

Spineflower, Monterey T Dicot Yes

(Chorizanthe pungens var. pungens) Terrestrial

Spineflower, Orcutt's E Dicot No

(Chorizanthe orcuttiana) Terrestrial

Spineflower, Robust E Dicot Yes

(Chorizanthe robusta var. robusta) Terrestrial

Spineflower, Scotts Valley E Dicot Yes

(Chorizanthe robusta var. hartwegii) Terrestrial
Page 33 of 216 

Spineflower, Slender-horned E Dicot No

(Dodecahema leptoceras) Terrestrial

Spineflower, Sonoma E Dicot No

(Chorizanthe valida) Terrestrial

Spurge, Hoover's T Dicot Yes

(Chamaesyce hooveri) Vernal pool

Stickyseed, Baker's E Dicot No

(Blennosperma bakeri) Vernal pool

Stonecrop, Lake County E Dicot No

(Parvisedum leiocarpum) Vernal pool

Sunflower, San Mateo Woolly E Dicot No

(Eriophyllum latilobum) Terrestrial

Taraxacum, California E Dicot No

(Taraxacum californicum) Terrestrial

Tarplant, Gaviota E Dicot Yes

(Deinandra increscens ssp. villosa) Terrestrial

Tarplant, Otay T Dicot Yes

(Deinandra (=Hemizonia) conjugens) Terrestrial

Tarplant, Santa Cruz T Dicot Yes

(Holocarpha macradenia) Terrestrial

Thistle, Chorro creek Bog E Dicot No

(Cirsium fontinale var. obispoense) Terrestrial, Freshwater

Thistle, Fountain E Dicot No

(Cirsium fontinale var. fontinale) Terrestrial

Thistle, La Graciosa E Dicot Yes

(Cirsium loncholepis) Freshwater, Brackish, Saltwater, 

Thistle, Suisun E Dicot No

(Cirsium hydrophilum var. hydrophilum) Terrestrial, Brackish

Thornmint, San Diego T Dicot No

(Acanthomintha ilicifolia) Terrestrial

Thornmint, San Mateo E Dicot No

(Acanthomintha obovata ssp. duttonii) Terrestrial

Tuctoria, Green's E Dicot Yes

(Tuctoria greenei) Vernal pool

Vervain, California T Dicot No

(Verbena californica) Terrestrial

Wallflower, Ben Lomond E Dicot No

(Erysimum teretifolium) Terrestrial

Wallflower, Contra Costa E Dicot Yes

(Erysimum capitatum var. angustatum) Terrestrial

Wallflower, Menzie's E Dicot No

(Erysimum menziesii) Terrestrial

Watercress, Gambel's E Dicot No

(Rorippa gambellii) Terrestrial, Freshwater, Brackish

Woodland-star, San Clemente Island E Dicot No

(Lithophragma maximum) Terrestrial

Woolly-star, Santa Ana River E Dicot No

(Eriastrum densifolium ssp. sanctorum) Terrestrial

Woolly-threads, San Joaquin E Dicot No

(Monolopia (=Lembertia) congdonii) Terrestrial

Yerba Santa, Lompoc E Dicot Yes

(Eriodictyon capitatum) Terrestrial
Page 34 of 216 

Chub, Bonytail E Fish Yes

(Gila elegans) Freshwater

Chub, Hutton Tui T Fish No

(Gila bicolor ssp.) Freshwater

Chub, Mohave Tui E Fish No

(Gila bicolor mohavensis) Freshwater

Chub, Owens Tui E Fish Yes

(Gila bicolor snyderi) Freshwater

Goby, Tidewater E Fish Yes

(Eucyclogobius newberryi) Freshwater

Pupfish, Desert E Fish Yes

(Cyprinodon macularius) Freshwater

Pupfish, Owens E Fish No

(Cyprinodon radiosus) Freshwater

Salmon, Chinook E/T Fish Yes

(Oncorhynchus (=Salmo) tshawytscha) Freshwater, Brackish, Saltwater

Salmon, Coho E Fish No

(Oncorhynchus (=Salmo) kisutch) Freshwater, Brackish, Saltwater

Smelt, Delta T Fish Yes

(Hypomesus transpacificus) Freshwater, Brackish

Squawfish, Colorado E Fish Yes

(Ptychocheilus lucius) Freshwater

Steelhead E Fish Yes

(Oncorhynchus (=Salmo) mykiss) Freshwater, Brackish, Saltwater

Stickleback, Unarmored Threespine E Fish Yes

(Gasterosteus aculeatus williamsoni) Freshwater

Sturgeon, North American green T Fish No

(Acipenser medirostris) Freshwater, Saltwater

Sucker, Lost River E Fish No

(Deltistes luxatus) Freshwater

Sucker, Modoc E Fish Yes

(Catostomus microps) Freshwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Sucker, Santa Ana T Fish Yes

(Catostomus santaanae) Freshwater

Sucker, Shortnose E Fish No

(Chasmistes brevirostris) Freshwater

Trout, Lahontan Cutthroat T Fish No

(Oncorhynchus clarki henshawi) Freshwater

Trout, Little Kern Golden T Fish Yes

(Oncorhynchus aguabonita whitei) Freshwater

Trout, Paiute Cutthroat T Fish No

(Oncorhynchus clarki seleniris) Freshwater

Abalone, White E Gastropod No

(Haliotis sorenseni) Saltwater

Snail, Morro Shoulderband E Gastropod Yes

(Helminthoglypta walkeriana) Terrestrial

Beetle, Delta Green Ground T Insect Yes

(Elaphrus viridis) Terrestrial, Vernal pool

Beetle, Mount Hermon June E Insect No

(Polyphylla barbata) Terrestrial, Subterraneous
Page 35 of 216 

Beetle, Ohlone Tiger E Insect No

(Cicindela ohlone) Terrestrial

Beetle, Valley Elderberry Longhorn T Insect Yes

(Desmocerus californicus dimorphus) Terrestrial

Butterfly, Bay Checkerspot (Wright's euphydryas) T Insect Yes

(Euphydryas editha bayensis) Terrestrial

Butterfly, Behren's Silverspot E Insect No

(Speyeria zerene behrensii) Terrestrial

Butterfly, Callippe Silverspot E Insect No

(Speyeria callippe callippe) Terrestrial

Butterfly, El Segundo Blue E Insect No

(Euphilotes battoides allyni) Terrestrial

Butterfly, Lange's Metalmark E Insect No

(Apodemia mormo langei) Terrestrial

Butterfly, Lotis Blue E Insect No

(Lycaeides argyrognomon lotis) Terrestrial

Butterfly, Mission Blue E Insect No

(Icaricia icarioides missionensis) Terrestrial

Butterfly, Myrtle's Silverspot E Insect No

(Speyeria zerene myrtleae) Terrestrial

Butterfly, Oregon Silverspot T Insect Yes

(Speyeria zerene hippolyta) Terrestrial

Butterfly, Palos Verdes Blue E Insect Yes

(Glaucopsyche lygdamus palosverdesensis) Terrestrial

Butterfly, Quino Checkerspot E Insect Yes

(Euphydryas editha quino (=E. e. wrighti)) Terrestrial

Butterfly, San Bruno Elfin E Insect No

(Callophrys mossii bayensis) Terrestrial

Butterfly, Smith's Blue E Insect No

(Euphilotes enoptes smithi) Terrestrial

Fly, Delhi Sands Flower-loving E Insect No

(Rhaphiomidas terminatus abdominalis) Terrestrial

Grasshopper, Zayante Band-winged E Insect Yes

(Trimerotropis infantilis) Terrestrial

Moth, Kern Primrose Sphinx T Insect No

(Euproserpinus euterpe) Terrestrial

Skipper, Carson Wandering E Insect No

(Pseudocopaeodes eunus obscurus) Terrestrial

Skipper, Laguna Mountain E Insect No

(Pyrgus ruralis lagunae) Terrestrial

Fox, San Joaquin Kit E Mammal No

(Vulpes macrotis mutica) Terrestrial

Fox, San Miguel Island E Mammal Yes

(Urocyon littoralis littoralis) Terrestrial

Fox, Santa Catalina Island E Mammal Yes

(Urocyon littoralis catalinae) Terrestrial

Fox, Santa Cruz Island E Mammal Yes

(Urocyon littoralis santacruzae) Terrestrial

Fox, Santa Rosa Island E Mammal Yes

(Urocyon littoralis santarosae) Terrestrial

Jaguar E Mammal No

(Panthera onca) Terrestrial
Page 36 of 216 

Kangaroo Rat, Fresno E Mammal Yes

(Dipodomys nitratoides exilis) Terrestrial

Kangaroo Rat, Giant E Mammal No

(Dipodomys ingens) Terrestrial

Kangaroo Rat, Morro Bay E Mammal Yes

(Dipodomys heermanni morroensis) Terrestrial

Kangaroo Rat, San Bernardino Merriam's E Mammal Yes

(Dipodomys merriami parvus) Terrestrial

Kangaroo Rat, Stephens' E Mammal No

(Dipodomys stephensi (incl. D. cascus)) Terrestrial

Kangaroo Rat, Tipton E Mammal No

(Dipodomys nitratoides nitratoides) Terrestrial

Mountain Beaver, Point Arena E Mammal No

(Aplodontia rufa nigra) Terrestrial, Freshwater

Mouse, Pacific Pocket E Mammal No

(Perognathus longimembris pacificus) Terrestrial

Mouse, Salt Marsh Harvest E Mammal No

(Reithrodontomys raviventris) Terrestrial

Rabbit, Riparian Brush E Mammal No

(Sylvilagus bachmani riparius) Terrestrial

Sheep, Peninsular Bighorn E Mammal Yes

(Ovis canadensis) Terrestrial

Sheep, Sierra Nevada Bighorn E Mammal No

(Ovis canadensis californiana) Terrestrial

Shrew, Buena Vista Lake Ornate E Mammal Yes

(Sorex ornatus relictus) Terrestrial

Vole, Amargosa E Mammal Yes

(Microtus californicus scirpensis) Terrestrial

Woodrat, Riparian E Mammal No

(Neotoma fuscipes riparia) Terrestrial

Otter, Southern Sea T Marine mml No

(Enhydra lutris nereis) Saltwater

Seal, Guadalupe Fur T Marine mml No

(Arctocephalus townsendi) Saltwater, Coastal

Sea-lion, Steller (eastern) T Marine mml Yes

(Eumetopias jubatus) Saltwater, Coastal

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Pacific right E Marine mml Yes

(Eubalaena japonica) Saltwater

Alopecurus, Sonoma E Monocot No

(Alopecurus aequalis var. sonomensis) Terrestrial

Amole, Cammatta Canyon T Monocot Yes

(Chlorogalum purpureum var. reductum) Terrestrial

Amole, Purple T Monocot Yes

(Chlorogalum purpureum var. purpureum) Terrestrial

Bluegrass, Napa E Monocot No

(Poa napensis) Terrestrial, Freshwater

Bluegrass, San Bernardino E Monocot No

(Poa atropurpurea) Terrestrial
Page 37 of 216 

Brodiaea, Chinese Camp T Monocot No

(Brodiaea pallida) Terrestrial

Brodiaea, Thread-leaved T Monocot Yes

(Brodiaea filifolia) Terrestrial

Grass, California Orcutt E Monocot No

(Orcuttia californica) Terrestrial, Vernal pool

Grass, Colusa T Monocot Yes

(Neostapfia colusana) Vernal pool

Grass, San Joaquin Valley Orcutt T Monocot Yes

(Orcuttia inaequalis) Vernal pool

Grass, Solano E Monocot Yes

(Tuctoria mucronata) Terrestrial, Vernal pool

Lily, Pitkin Marsh E Monocot No

(Lilium pardalinum ssp. pitkinense) Freshwater

Lily, Western E Monocot No

(Lilium occidentale) Terrestrial

Onion, Munz's E Monocot Yes

(Allium munzii) Terrestrial

Piperia, Yadon's E Monocot Yes

(Piperia yadonii) Terrestrial

Sedge, White E Monocot No

(Carex albida) Terrestrial, Freshwater

Lizard, Blunt-nosed Leopard E Reptile No

(Gambelia silus) Terrestrial

Lizard, Coachella Valley Fringe-toed T Reptile Yes

(Uma inornata) Terrestrial

Lizard, Island Night T Reptile No

(Xantusia riversiana) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Sea turtle, olive ridley T Reptile No

(Lepidochelys olivacea) Saltwater

Snake, Giant Garter T Reptile No

(Thamnophis gigas) Terrestrial, Freshwater

Snake, San Francisco Garter E Reptile No

(Thamnophis sirtalis tetrataenia) Terrestrial, Freshwater

Tortoise, Desert T Reptile Yes

(Gopherus agassizii) Terrestrial

Whipsnake (=Striped Racer), Alameda T Reptile Yes

(Masticophis lateralis euryxanthus) Terrestrial

Colorado ( 20) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Owl, Mexican Spotted T Bird Yes

(Strix occidentalis lucida) Terrestrial

Beardtongue, Penland E Dicot No

(Penstemon penlandii) Terrestrial

Butterfly Plant, Colorado T Dicot Yes
Page 38 of 216 

(Gaura neomexicana var. coloradensis) Terrestrial

Cactus, Knowlton E Dicot No

(Pediocactus knowltonii) Terrestrial

Cactus, Mesa Verde T Dicot No

(Sclerocactus mesae-verdae) Terrestrial

Cactus, Uinta Basin Hookless T Dicot No

(Sclerocactus glaucus) Terrestrial

Milk-vetch, Mancos E Dicot No

(Astragalus humillimus) Terrestrial

Milk-vetch, Osterhout E Dicot No

(Astragalus osterhoutii) Terrestrial

Wild-buckwheat, Clay-loving E Dicot Yes

(Eriogonum pelinophilum) Terrestrial

Chub, Bonytail E Fish Yes

(Gila elegans) Freshwater

Chub, Humpback E Fish Yes

(Gila cypha) Freshwater

Squawfish, Colorado E Fish Yes

(Ptychocheilus lucius) Freshwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Trout, Greenback Cutthroat T Fish No

(Oncorhynchus clarki stomias) Freshwater

Butterfly, Uncompahgre Fritillary E Insect No

(Boloria acrocnema) Terrestrial

Skipper, Pawnee Montane T Insect No

(Hesperia leonardus montana) Terrestrial

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Mouse, Preble's Meadow Jumping T Mammal Yes

(Zapus hudsonius preblei) Terrestrial

Ladies'-tresses, Ute T Monocot No

(Spiranthes diluvialis) Terrestrial

Connecticut ( 15) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Gerardia, Sandplain E Dicot No

(Agalinis acuta) Terrestrial

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Beetle, Puritan Tiger T Insect No

(Cicindela puritana) Terrestrial, Coastal

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial
Page 39 of 216 

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

Delaware ( 14) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Squirrel, Delmarva Peninsula Fox E Mammal No

(Sciurus niger cinereus) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

Florida ( 104) species: Taxa Critical Habitat

Salamander, Flatwoods T Amphibian No

(Ambystoma cingulatum) Terrestrial, Freshwater, Vernal pool

Caracara, Audubon's Crested T Bird No

(Polyborus plancus audubonii) Terrestrial

Kite, Everglade Snail E Bird Yes

(Rostrhamus sociabilis plumbeus) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Scrub-Jay, Florida T Bird No

(Aphelocoma coerulescens) Terrestrial
Page 40 of 216 

Sparrow, Cape Sable Seaside E Bird Yes

(Ammodramus maritimus mirabilis) Terrestrial

Sparrow, Florida Grasshopper E Bird No

(Ammodramus savannarum floridanus) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Bankclimber, Purple T Bivalve No

(Elliptoideus sloatianus) Freshwater

Mussel, Fat Threeridge E Bivalve No

(Amblema neislerii) Freshwater

Mussel, Gulf Moccasinshell E Bivalve No

(Medionidus penicillatus) Freshwater

Mussel, Ochlockonee Moccasinshell E Bivalve No

(Medionidus simpsonianus) Freshwater

Mussel, Oval Pigtoe E Bivalve No

(Pleurobema pyriforme) Freshwater

Mussel, Shiny-rayed Pocketbook E Bivalve No

(Lampsilis subangulata) Freshwater

Slabshell, Chipola T Bivalve No

(Elliptio chipolaensis) Freshwater

Torreya, Florida E Conf/cycds No

(Torreya taxifolia) Terrestrial

Coral, Staghorn T Coral No

(Acropora cervicornis) Saltwater

Shrimp, Squirrel Chimney Cave T Crustacean No

(Palaemonetes cummingi) Freshwater, Subterraneous

Aster, Florida Golden E Dicot No

(Chrysopsis floridana) Terrestrial

Bellflower, Brooksville E Dicot No

(Campanula robinsiae) Terrestrial

Birds-in-a-nest, White T Dicot No

(Macbridea alba) Terrestrial

Blazing Star, Scrub E Dicot No

(Liatris ohlingerae) Terrestrial

Bonamia, Florida T Dicot No

(Bonamia grandiflora) Terrestrial

Buckwheat, Scrub T Dicot No

(Eriogonum longifolium var. gnaphalifolium) Terrestrial

Butterwort, Godfrey's T Dicot No

(Pinguicula ionantha) Terrestrial, Freshwater

Cactus, Key Tree E Dicot No

(Pilosocereus robinii) Terrestrial

Campion, Fringed E Dicot No

(Silene polypetala) Terrestrial

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Fringe Tree, Pygmy E Dicot No

(Chionanthus pygmaeus) Terrestrial
Page 41 of 216 

Gooseberry, Miccosukee T Dicot No

(Ribes echinellum) Terrestrial

Gourd, Okeechobee E Dicot No

(Cucurbita okeechobeensis ssp. okeechobeensis) Terrestrial

Harebells, Avon Park E Dicot No

(Crotalaria avonensis) Terrestrial

Hypericum, Highlands Scrub E Dicot No

(Hypericum cumulicola) Terrestrial

Jacquemontia, Beach E Dicot No

(Jacquemontia reclinata) Terrestrial, Coastal

Lupine, Scrub E Dicot No

(Lupinus aridorum) Terrestrial

Meadowrue, Cooley's E Dicot No

(Thalictrum cooleyi) Terrestrial

Milkpea, Small's E Dicot No

(Galactia smallii) Terrestrial

Mint, Garrett's E Dicot No

(Dicerandra christmanii) Terrestrial

Mint, Lakela's E Dicot No

(Dicerandra immaculata) Terrestrial

Mint, Longspurred E Dicot No

(Dicerandra cornutissima) Terrestrial

Mint, Scrub E Dicot No

(Dicerandra frutescens) Terrestrial

Mustard, Carter's E Dicot No

(Warea carteri) Terrestrial

Pawpaw, Beautiful E Dicot No

(Deeringothamnus pulchellus) Terrestrial

Pawpaw, Four-petal E Dicot No

(Asimina tetramera) Terrestrial

Pawpaw, Rugel's E Dicot No

(Deeringothamnus rugelii) Terrestrial

Pinkroot, Gentian E Dicot No

(Spigelia gentianoides) Terrestrial

Plum, Scrub E Dicot No

(Prunus geniculata) Terrestrial

Polygala, Lewton's E Dicot No

(Polygala lewtonii) Terrestrial

Polygala, Tiny E Dicot No

(Polygala smallii) Terrestrial

Prickly-apple, Fragrant E Dicot No

(Cereus eriophorus var. fragrans) Terrestrial

Rhododendron, Chapman E Dicot No

(Rhododendron chapmanii) Terrestrial

Rosemary, Etonia E Dicot No

(Conradina etonia) Terrestrial

Rosemary, Short-leaved E Dicot No

(Conradina brevifolia) Terrestrial

Sandlace E Dicot No

(Polygonella myriophylla) Terrestrial

Snakeroot E Dicot No

(Eryngium cuneifolium) Terrestrial
Page 42 of 216 

Spurge, Deltoid E Dicot No

(Chamaesyce deltoidea ssp. deltoidea) Terrestrial

Spurge, Garber's T Dicot No

(Chamaesyce garberi) Terrestrial

Spurge, Telephus T Dicot No

(Euphorbia telephioides) Terrestrial

Warea, Wide-leaf E Dicot No

(Warea amplexifolia) Terrestrial

Water-willow, Cooley's E Dicot No

(Justicia cooleyi) Terrestrial

Whitlow-wort, Papery T Dicot No

(Paronychia chartacea) Terrestrial

Wings, Pigeon T Dicot No

(Clitoria fragrans) Terrestrial

Wireweed E Dicot No

(Polygonella basiramia) Terrestrial

Ziziphus, Florida E Dicot No

(Ziziphus celata) Terrestrial

Darter, Okaloosa E Fish No

(Etheostoma okaloosae) Freshwater

Sawfish, Smalltooth E Fish No

(Pristis pectinata) Freshwater, Brackish, Saltwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Snail, Stock Island Tree T Gastropod No

(Orthalicus reses (not incl. nesodryas)) Terrestrial

Butterfly, Schaus Swallowtail E Insect No

(Heraclides aristodemus ponceanus) Terrestrial

Cladonia, Florida Perforate E Lichen No

(Cladonia perforata) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Deer, Key E Mammal No

(Odocoileus virginianus clavium) Terrestrial

Mouse, Anastasia Island Beach E Mammal No

(Peromyscus polionotus phasma) Terrestrial, Coastal

Mouse, Choctawhatchee Beach E Mammal Yes

(Peromyscus polionotus allophrys) Terrestrial, Coastal

Mouse, Key Largo Cotton E Mammal Yes

(Peromyscus gossypinus allapaticola) Terrestrial

Mouse, Perdido Key Beach E Mammal Yes

(Peromyscus polionotus trissyllepsis) Coastal

Mouse, Southeastern Beach T Mammal No

(Peromyscus polionotus niveiventris) Terrestrial, Coastal

Panther, Florida E Mammal No

(Puma (=Felis) concolor coryi) Terrestrial

Rabbit, Lower Keys Marsh E Mammal No

(Sylvilagus palustris hefneri) Terrestrial
Page 43 of 216 

Rice Rat (=Silver Rice Rat) E Mammal Yes

(Oryzomys palustris natator) Terrestrial

Vole, Florida Salt Marsh E Mammal No

(Microtus pennsylvanicus dukecampbelli) Terrestrial, Brackish

Wolf, Red E Mammal No

(Canis rufus) Terrestrial

Woodrat, Key Largo E Mammal No

(Neotoma floridana smalli) Terrestrial

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Seal, Caribbean Monk E Marine mml No

(Monachus tropicalis) Saltwater, Coastal

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Beargrass, Britton's E Monocot No

(Nolina brittoniana) Terrestrial

Seagrass, Johnson's T Monocot Yes

(Halophila johnsonii) Saltwater, Coastal

Crocodile, American T Reptile Yes

(Crocodylus acutus) Terrestrial, Freshwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Skink, Blue-tailed Mole T Reptile No

(Eumeces egregius lividus) Terrestrial

Skink, Sand T Reptile No

(Neoseps reynoldsi) Terrestrial

Snake, Atlantic Salt Marsh T Reptile No

(Nerodia clarkii taeniata) Terrestrial, Brackish, Saltwater

Snake, Eastern Indigo T Reptile Yes

(Drymarchon corais couperi) Terrestrial

Georgia ( 65) species: Taxa Critical Habitat

Salamander, Flatwoods T Amphibian No

(Ambystoma cingulatum) Terrestrial, Freshwater, Vernal pool

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Warbler (=Wood), Kirtland's E Bird No

(Dendroica kirtlandii) Terrestrial

Woodpecker, Red-cockaded E Bird No
Page 44 of 216 

(Picoides borealis) Terrestrial

Bankclimber, Purple T Bivalve No

(Elliptoideus sloatianus) Freshwater

Combshell, Upland E Bivalve Yes

(Epioblasma metastriata) Freshwater

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Kidneyshell, Triangular E Bivalve Yes

(Ptychobranchus greenii) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Acornshell Southern E Bivalve Yes

(Epioblasma othcaloogensis) Freshwater

Mussel, Alabama Moccasinshell T Bivalve Yes

(Medionidus acutissimus) Freshwater

Mussel, Coosa Moccasinshell E Bivalve Yes

(Medionidus parvulus) Freshwater

Mussel, Fat Threeridge E Bivalve No

(Amblema neislerii) Freshwater

Mussel, Fine-lined Pocketbook T Bivalve Yes

(Lampsilis altilis) Freshwater

Mussel, Gulf Moccasinshell E Bivalve No

(Medionidus penicillatus) Freshwater

Mussel, Oval Pigtoe E Bivalve No

(Pleurobema pyriforme) Freshwater

Mussel, Ovate Clubshell E Bivalve Yes

(Pleurobema perovatum) Freshwater

Mussel, Shiny-rayed Pocketbook E Bivalve No

(Lampsilis subangulata) Freshwater

Mussel, Southern Clubshell E Bivalve Yes

(Pleurobema decisum) Freshwater

Mussel, Southern Pigtoe E Bivalve Yes

(Pleurobema georgianum) Freshwater

Torreya, Florida E Conf/cycds No

(Torreya taxifolia) Terrestrial

Amphianthus, Little T Dicot No

(Amphianthus pusillus) Freshwater

Barbara Buttons, Mohr's T Dicot No

(Marshallia mohrii) Terrestrial

Campion, Fringed E Dicot No

(Silene polypetala) Terrestrial

Dropwort, Canby's E Dicot No

(Oxypolis canbyi) Terrestrial, Freshwater

Pitcher-plant, Green E Dicot No

(Sarracenia oreophila) Terrestrial, Freshwater

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Rattleweed, Hairy E Dicot No

(Baptisia arachnifera) Terrestrial

Skullcap, Large-flowered T Dicot No

(Scutellaria montana) Terrestrial

Spiraea, Virginia T Dicot No
Page 45 of 216 

(Spiraea virginiana) Terrestrial

Sumac, Michaux's E Dicot No

(Rhus michauxii) Terrestrial

Quillwort, Black-spored E Ferns No

(Isoetes melanospora) Vernal pool

Quillwort, Mat-forming E Ferns No

(Isoetes tegetiformans) Vernal pool

Chub, Spotfin T Fish Yes

(Erimonax monachus) Freshwater

Darter, Amber E Fish Yes

(Percina antesella) Freshwater

Darter, Cherokee T Fish No

(Etheostoma scotti) Freshwater

Darter, Etowah E Fish No

(Etheostoma etowahae) Freshwater

Darter, Goldline T Fish No

(Percina aurolineata) Freshwater

Darter, Snail T Fish No

(Percina tanasi) Freshwater

Logperch, Conasauga E Fish Yes

(Percina jenkinsi) Freshwater

Madtom, Yellowfin T Fish Yes

(Noturus flavipinnis) Freshwater

Shiner, Blue T Fish No

(Cyprinella caerulea) Freshwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Virginia Big-eared E Mammal Yes

(Corynorhinus (=Plecotus) townsendii virginianus) Terrestrial, Subterraneous

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Grass, Tennessee Yellow-eyed E Monocot No

(Xyris tennesseensis) Terrestrial

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Trillium, Persistent E Monocot No
Page 46 of 216 

(Trillium persistens) Terrestrial

Trillium, Relict E Monocot No

(Trillium reliquum) Terrestrial

Water-plantain, Kral's T Monocot No

(Sagittaria secundifolia) Freshwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Snake, Eastern Indigo T Reptile Yes

(Drymarchon corais couperi) Terrestrial

Hawaii ( 316) species: Taxa Critical Habitat

Spider, Kauai Cave Wolf E Arachnid Yes

(Adelocosa anops) Terrestrial, Subterraneous

'Akepa, Hawaii E Bird No

(Loxops coccineus coccineus) Terrestrial

'Akepa, Maui E Bird No

(Loxops coccineus ochraceus) Terrestrial

'Akia Loa, Kauai (Hemignathus procerus) E Bird No

(Hemignathus procerus) Terrestrial

'Akia Pola'au (Hemignathus munroi) E Bird No

(Hemignathus munroi) Terrestrial

Albatross, Short-tailed E Bird No

(Phoebastria (=Diomedea) albatrus) Terrestrial, Saltwater

Coot, Hawaiian (=Alae keo keo) E Bird No

(Fulica americana alai) Terrestrial

Creeper, Hawaii E Bird No

(Oreomystis mana) Terrestrial

Creeper, Molokai (Kakawahie) E Bird No

(Paroreomyza flammea) Terrestrial

Creeper, Oahu (Alauwahio) E Bird No

(Paroreomyza maculata) Terrestrial

Crow, Hawaiian ('Alala) E Bird No

(Corvus hawaiiensis) Terrestrial

Duck, Hawaiian (Koloa) E Bird No

(Anas wyvilliana) Terrestrial, Freshwater

Duck, Laysan E Bird No

(Anas laysanensis) Terrestrial, Freshwater

Elepaio, Oahu E Bird Yes

(Chasiempis sandwichensis ibidis) Terrestrial

Finch, Laysan E Bird No

(Telespyza cantans) Terrestrial

Finch, Nihoa E Bird No

(Telespyza ultima) Terrestrial

Goose, Hawaiian (Nene) E Bird No

(Branta (=Nesochen) sandvicensis) Terrestrial, Freshwater
Page 47 of 216 

Hawk, Hawaiian (Io) E Bird No

(Buteo solitarius) Terrestrial

Honeycreeper, Crested ('Akohekohe) E Bird No

(Palmeria dolei) Terrestrial

Millerbird, Nihoa E Bird No

(Acrocephalus familiaris kingi) Terrestrial

Moorhen, Hawaiian Common E Bird No

(Gallinula chloropus sandvicensis) Terrestrial

Nuku Pu'u E Bird No

(Hemignathus lucidus) Terrestrial

'O'o, Kauai (='A'a) E Bird No

(Moho braccatus) Terrestrial

'O'u (Honeycreeper) E Bird No

(Psittirostra psittacea) Terrestrial

Palila E Bird Yes

(Loxioides bailleui) Terrestrial

Parrotbill, Maui E Bird No

(Pseudonestor xanthophrys) Terrestrial

Petrel, Hawaiian Dark-rumped E Bird No

(Pterodroma phaeopygia sandwichensis) Terrestrial

Po'ouli E Bird No

(Melamprosops phaeosoma) Terrestrial

Shearwater, Newell's Townsend's T Bird No

(Puffinus auricularis newelli) Terrestrial, Saltwater

Stilt, Hawaiian (=Ae'o) E Bird No

(Himantopus mexicanus knudseni) Terrestrial

Thrush, Large Kauai E Bird No

(Myadestes myadestinus) Terrestrial

Thrush, Molokai (Oloma'o) E Bird No

(Myadestes lanaiensis rutha) Terrestrial

Thrush, Small Kauai (Puaiohi) E Bird No

(Myadestes palmeri) Terrestrial

Amphipod, Kauai Cave E Crustacean Yes

(Spelaeorchestia koloana) Freshwater, Subterraneous

Abutilon eremitopetalum (ncn) E Dicot Yes

(Abutilon eremitopetalum) Terrestrial

Abutilon sandwicense (ncn) E Dicot Yes

(Abutilon sandwicense) Terrestrial

Achyranthes mutica (ncn) E Dicot Yes

(Achyranthes mutica) Terrestrial

Achyranthes splendens var. rotundata (ncn) E Dicot No

(Achyranthes splendens var. rotundata) Terrestrial

A'e (Zanthoxylum dipetalum var. tomentosum) E Dicot Yes

(Zanthoxylum dipetalum var. tomentosum) Terrestrial

A'e (Zanthoxylum hawaiiense) E Dicot Yes

(Zanthoxylum hawaiiense) Terrestrial

'Aiea (Nothocestrum breviflorum) E Dicot Yes

(Nothocestrum breviflorum) Terrestrial

'Aiea (Nothocestrum peltatum) E Dicot Yes

(Nothocestrum peltatum) Terrestrial

'Akoko (Chamaesyce celastroides var. kaenana) E Dicot Yes

(Chamaesyce celastroides var. kaenana) Terrestrial
Page 48 of 216 

'Akoko (Chamaesyce deppeana) E Dicot Yes

(Chamaesyce deppeana) Terrestrial

'Akoko (Chamaesyce herbstii) E Dicot Yes

(Chamaesyce herbstii) Terrestrial

'Akoko (Chamaesyce kuwaleana) E Dicot Yes

(Chamaesyce kuwaleana) Terrestrial

'Akoko (Chamaesyce rockii) E Dicot Yes

(Chamaesyce rockii) Terrestrial

'Akoko (Chamaesyce skottsbergii var. skottsbe E Dicot No

(Chamaesyce skottsbergii var. kalaeloana) Terrestrial

'Akoko (Euphorbia haeleeleana) E Dicot Yes

(Euphorbia haeleeleana) Terrestrial

Alani (Melicope adscendens) E Dicot Yes

(Melicope adscendens) Terrestrial

Alani (Melicope balloui) E Dicot Yes

(Melicope balloui) Terrestrial

Alani (Melicope haupuensis) E Dicot Yes

(Melicope haupuensis) Terrestrial

Alani (Melicope knudsenii) E Dicot Yes

(Melicope knudsenii) Terrestrial

Alani (Melicope lydgatei) E Dicot Yes

(Melicope lydgatei) Terrestrial

Alani (Melicope mucronulata) E Dicot Yes

(Melicope mucronulata) Terrestrial

Alani (Melicope munroi) E Dicot No

(Melicope munroi) Terrestrial

Alani (Melicope ovalis) E Dicot Yes

(Melicope ovalis) Terrestrial

Alani (Melicope pallida) E Dicot Yes

(Melicope pallida) Terrestrial

Alani (Melicope quadrangularis) E Dicot No

(Melicope quadrangularis) Terrestrial

Alani (Melicope reflexa) E Dicot Yes

(Melicope reflexa) Terrestrial

Alani (Melicope saint-johnii) E Dicot Yes

(Melicope saint-johnii) Terrestrial

Alani (Melicope zahlbruckneri) E Dicot Yes

(Melicope zahlbruckneri) Terrestrial

Alsinidendron obovatum (ncn) E Dicot Yes

(Alsinidendron obovatum) Terrestrial

Alsinidendron trinerve (ncn) E Dicot Yes

(Alsinidendron trinerve) Terrestrial

Alsinidendron viscosum (ncn) E Dicot Yes

(Alsinidendron viscosum) Terrestrial

Amaranthus brownii (ncn) E Dicot Yes

(Amaranthus brownii) Terrestrial

'Anaunau (Lepidium arbuscula) E Dicot Yes

(Lepidium arbuscula) Terrestrial

'Anunu (Sicyos alba) E Dicot Yes

(Sicyos alba) Terrestrial

Aupaka (Isodendrion hosakae) E Dicot Yes

(Isodendrion hosakae) Terrestrial
Page 49 of 216 

Aupaka (Isodendrion laurifolium) E Dicot Yes

(Isodendrion laurifolium) Terrestrial

Aupaka (Isodendrion longifolium) T Dicot Yes

(Isodendrion longifolium) Terrestrial

'Awikiwiki (Canavalia molokaiensis) E Dicot Yes

(Canavalia molokaiensis) Terrestrial

'Awiwi (Centaurium sebaeoides) E Dicot Yes

(Centaurium sebaeoides) Terrestrial

'Awiwi (Hedyotis cookiana) E Dicot Yes

(Hedyotis cookiana) Terrestrial

Bonamia menziesii (ncn) E Dicot Yes

(Bonamia menziesii) Terrestrial

Chamaesyce Halemanui (ncn) E Dicot Yes

(Chamaesyce halemanui) Terrestrial

Cyanea undulata (ncn) E Dicot Yes

(Cyanea undulata) Terrestrial

Delissea rhytodisperma (ncn) E Dicot Yes

(Delissea rhytidosperma) Terrestrial

Dubautia latifolia (ncn) E Dicot Yes

(Dubautia latifolia) Terrestrial

Dubautia pauciflorula (ncn) E Dicot Yes

(Dubautia pauciflorula) Terrestrial

Geranium, Hawaiian Red-flowered E Dicot Yes

(Geranium arboreum) Terrestrial

Gouania hillebrandii (ncn) E Dicot Yes

(Gouania hillebrandii) Terrestrial

Gouania meyenii (ncn) E Dicot Yes

(Gouania meyenii) Terrestrial

Gouania vitifolia (ncn) E Dicot Yes

(Gouania vitifolia) Terrestrial

Haha (Cyanea acuminata) E Dicot Yes

(Cyanea acuminata) Terrestrial

Haha (Cyanea asarifolia) E Dicot Yes

(Cyanea asarifolia) Terrestrial

Haha (Cyanea copelandii ssp. copelandii) E Dicot No

(Cyanea copelandii ssp. copelandii) Terrestrial

Haha (Cyanea copelandii ssp. haleakalaensis) E Dicot Yes

(Cyanea copelandii ssp. haleakalaensis) Terrestrial

Haha (Cyanea Crispa) (=Rollandia crispa) E Dicot Yes

(Cyanea (=Rollandia) crispa) Terrestrial

Haha (Cyanea dunbarii) E Dicot Yes

(Cyanea dunbarii) Terrestrial

Haha (Cyanea glabra) E Dicot Yes

(Cyanea glabra) Terrestrial

Haha (Cyanea grimesiana ssp. grimesiana) E Dicot Yes

(Cyanea grimesiana ssp. grimesiana) Terrestrial

Haha (Cyanea grimesiana ssp. obatae) E Dicot Yes

(Cyanea grimesiana ssp. obatae) Terrestrial

Haha (Cyanea hamatiflora ssp. carlsonii) E Dicot Yes

(Cyanea hamatiflora ssp. Carlsonii) Terrestrial

Haha (Cyanea hamatiflora ssp. hamatiflora) E Dicot Yes

(Cyanea hamatiflora ssp. hamatiflora) Terrestrial
Page 50 of 216 

Haha (Cyanea humboldtiana) E Dicot Yes

(Cyanea humboldtiana) Terrestrial

Haha (Cyanea koolauensis) E Dicot Yes

(Cyanea koolauensis) Terrestrial

Haha (Cyanea longiflora) E Dicot Yes

(Cyanea longiflora) Terrestrial

Haha (Cyanea Macrostegia var. gibsonii) E Dicot No

(Cyanea macrostegia ssp. gibsonii) Terrestrial

Haha (Cyanea mannii) E Dicot Yes

(Cyanea mannii) Terrestrial

Haha (Cyanea mceldowneyi) E Dicot Yes

(Cyanea mceldowneyi) Terrestrial

Haha (Cyanea pinnatifida) E Dicot Yes

(Cyanea pinnatifida) Terrestrial

Haha (Cyanea platyphylla) E Dicot Yes

(Cyanea platyphylla) Terrestrial

Haha (Cyanea procera) E Dicot Yes

(Cyanea procera) Terrestrial

Haha (Cyanea recta) T Dicot Yes

(Cyanea recta) Terrestrial

Haha (Cyanea remyi) E Dicot Yes

(Cyanea remyi) Terrestrial

Haha (Cyanea shipmanii) E Dicot Yes

(Cyanea shipmannii) Terrestrial

Haha (Cyanea stictophylla) E Dicot Yes

(Cyanea stictophylla) Terrestrial

Haha (Cyanea St-Johnii) (=Rollandia St-Johnii) E Dicot Yes

(Cyanea st-johnii) Terrestrial

Haha (Cyanea superba) E Dicot Yes

(Cyanea superba) Terrestrial

Ha'Iwale (Cyrtandra crenata) E Dicot No

(Cyrtandra crenata) Terrestrial

Ha'Iwale (Cyrtandra dentata) E Dicot Yes

(Cyrtandra dentata) Terrestrial

Ha'Iwale (Cyrtandra giffardii) E Dicot Yes

(Cyrtandra giffardii) Terrestrial

Ha'Iwale (Cyrtandra limahuliensis) T Dicot Yes

(Cyrtandra limahuliensis) Terrestrial

Ha'Iwale (Cyrtandra munroi) E Dicot Yes

(Cyrtandra munroi) Terrestrial

Ha'Iwale (Cyrtandra polyantha) E Dicot Yes

(Cyrtandra polyantha) Terrestrial

Ha'Iwale (Cyrtandra subumbellata) E Dicot Yes

(Cyrtandra subumbellata) Terrestrial

Ha'Iwale (Cyrtandra tintinnabula) E Dicot Yes

(Cyrtandra tintinnabula) Terrestrial

Ha'Iwale (Cyrtandra viridiflora) E Dicot Yes

(Cyrtandra viridiflora) Terrestrial

Haplostachys Haplostachya (ncn) E Dicot No

(Haplostachys haplostachya) Terrestrial

Hau Kauhiwi (Hibiscadelphus woodi) E Dicot Yes

(Hibiscadelphus woodii) Terrestrial
Page 51 of 216 

Hau Kuahiwi (Hibiscadelphus distans) E Dicot No

(Hibiscadelphus distans) Terrestrial

Heau (Exocarpos luteolus) E Dicot Yes

(Exocarpos luteolus) Terrestrial

Hedyotis degeneri (ncn) E Dicot Yes

(Hedyotis degeneri) Terrestrial

Hedyotis parvula (ncn) E Dicot Yes

(Hedyotis parvula) Terrestrial

Hedyotis St.-Johnii (ncn) E Dicot Yes

(Hedyotis st.-johnii) Terrestrial

Hesperomannia arborescens (ncn) E Dicot Yes

(Hesperomannia arborescens) Terrestrial

Hesperomannia arbuscula (ncn) E Dicot Yes

(Hesperomannia arbuscula) Terrestrial

Hesperomannia lydgatei (ncn) E Dicot Yes

(Hesperomannia lydgatei) Terrestrial

Hibiscus, Clay's E Dicot Yes

(Hibiscus clayi) Terrestrial

Holei (Ochrosia kilaueaensis) E Dicot No

(Ochrosia kilaueaensis) Terrestrial

Iliau (Wilkesia hobdyi) E Dicot Yes

(Wilkesia hobdyi) Terrestrial

Kamakahala (Labordia cyrtandrae) E Dicot Yes

(Labordia cyrtandrae) Terrestrial

Kamakahala (Labordia lydgatei) E Dicot Yes

(Labordia lydgatei) Terrestrial

Kamakahala (Labordia tinifolia var. lanaiensis) E Dicot No

(Labordia tinifolia var. lanaiensis) Terrestrial

Kamakahala (Labordia tinifolia var. wahiawaen) E Dicot Yes

(Labordia tinifolia var. wahiawaensis) Terrestrial

Kamakahala (Labordia triflora) E Dicot No

(Labordia triflora) Terrestrial

Kanaloa kahoolawensis (ncn) E Dicot Yes

(Kanaloa kahoolawensis) Terrestrial

Kauila (Colubrina oppositifolia) E Dicot Yes

(Colubrina oppositifolia) Terrestrial

Kaulu (Pteralyxia kauaiensis) E Dicot Yes

(Pteralyxia kauaiensis) Terrestrial

Kio'Ele (Hedyotis coriacea) E Dicot Yes

(Hedyotis coriacea) Terrestrial

Kiponapona (Phyllostegia racemosa) E Dicot Yes

(Phyllostegia racemosa) Terrestrial

Koki'o (Kokia drynarioides) E Dicot Yes

(Kokia drynarioides) Terrestrial

Koki'o (Kokia kauaiensis) E Dicot Yes

(Kokia kauaiensis) Terrestrial

Koki'o Ke'oke'o (Hibiscus arnottianus ssp. immaculatus) E Dicot Yes

(Hibiscus arnottianus ssp. immaculatus) Terrestrial

Koki'o Ke'oke'o (Hibiscus waimeae ssp. hannerae) E Dicot Yes

(Hibiscus waimeae ssp. hannerae) Terrestrial

Kolea (Myrsine juddii) E Dicot Yes

(Myrsine juddii) Terrestrial
Page 52 of 216 

Kolea (Myrsine linearifolia) T Dicot Yes

(Myrsine linearifolia) Terrestrial

Ko'oko'olau (Bidens micrantha ssp. kalealaha) E Dicot Yes

(Bidens micrantha ssp. kalealaha) Terrestrial

Ko'oko'olau (Bidens wiebkei) E Dicot Yes

(Bidens wiebkei) Terrestrial

Ko'oloa'ula (Abutilon menziesii) E Dicot No

(Abutilon menziesii) Terrestrial

Kopa (Hedyotis schlechtendahliana var. remyi) E Dicot No

(Hedyotis schlechtendahliana var. remyi) Terrestrial

Kuawawaenohu (Alsinidendron lychnoides) E Dicot Yes

(Alsinidendron lychnoides) Terrestrial

Kulu'I (Nototrichium humile) E Dicot Yes

(Nototrichium humile) Terrestrial

Laukahi Kuahiwi (Plantago hawaiensis) E Dicot Yes

(Plantago hawaiensis) Terrestrial

Laukahi Kuahiwi (Plantago princeps) E Dicot Yes

(Plantago princeps) Terrestrial

Laulihilihi (Schiedea stellarioides) E Dicot Yes

(Schiedea stellarioides) Terrestrial

Lipochaeta venosa (ncn) E Dicot No

(Lipochaeta venosa) Terrestrial

Lobelia monostachya (ncn) E Dicot Yes

(Lobelia monostachya) Terrestrial

Lobelia niihauensis (ncn) E Dicot Yes

(Lobelia niihauensis) Terrestrial

Lobelia oahuensis (ncn) E Dicot Yes

(Lobelia oahuensis) Terrestrial

Lysimachia filifolia (ncn) E Dicot Yes

(Lysimachia filifolia) Terrestrial

Lysimachia lydgatei (ncn) E Dicot Yes

(Lysimachia lydgatei) Terrestrial

Lysimachia maxima (ncn) E Dicot Yes

(Lysimachia maxima) Terrestrial

Mahoe (Alectryon macrococcus) E Dicot Yes

(Alectryon macrococcus) Terrestrial

Makou (Peucedanum sandwicense) T Dicot Yes

(Peucedanum sandwicense) Terrestrial

Ma'o Hau Hele (Hibiscus brackenridgei) E Dicot Yes

(Hibiscus brackenridgei) Terrestrial

Ma'oli'oli (Schiedea apokremnos) E Dicot Yes

(Schiedea apokremnos) Terrestrial

Ma'oli'oli (Schiedea kealiae) E Dicot Yes

(Schiedea kealiae) Terrestrial

Mapele (Cyrtandra cyaneoides) E Dicot Yes

(Cyrtandra cyaneoides) Terrestrial

Mehamehame (Flueggea neowawraea) E Dicot Yes

(Flueggea neowawraea) Terrestrial

Munroidendron racemosum (ncn) E Dicot Yes

(Munroidendron racemosum) Terrestrial

Na'ena'e (Dubautia herbstobatae) E Dicot Yes

(Dubautia herbstobatae) Terrestrial
Page 53 of 216 

Na'ena'e (Dubautia plantaginea ssp. humilis) E Dicot Yes

(Dubautia plantaginea ssp. humilis) Terrestrial

Nani Wai'ale'ale (Viola kauaensis var. wahiawaensis) E Dicot Yes

(Viola kauaiensis var. wahiawaensis) Terrestrial

Nanu (Gardenia mannii) E Dicot Yes

(Gardenia mannii) Terrestrial

Na'u (Gardenia brighamii) E Dicot No

(Gardenia brighamii) Terrestrial

Naupaka, Dwarf (Scaevola coriacea) E Dicot No

(Scaevola coriacea) Terrestrial

Nehe (Lipochaeta fauriei) E Dicot Yes

(Lipochaeta fauriei) Terrestrial

Nehe (Lipochaeta kamolensis) E Dicot Yes

(Lipochaeta kamolensis) Terrestrial

Nehe (Lipochaeta lobata var. leptophylla) E Dicot Yes

(Lipochaeta lobata var. leptophylla) Terrestrial

Nehe (Lipochaeta micrantha) E Dicot Yes

(Lipochaeta micrantha) Terrestrial

Nehe (Lipochaeta tenuifolia) E Dicot Yes

(Lipochaeta tenuifolia) Terrestrial

Nehe (Lipochaeta waimeaensis) E Dicot Yes

(Lipochaeta waimeaensis) Terrestrial

Neraudia angulata (ncn) E Dicot Yes

(Neraudia angulata) Terrestrial

Neraudia ovata (ncn) E Dicot Yes

(Neraudia ovata) Terrestrial

Neraudia sericea (ncn) E Dicot Yes

(Neraudia sericea) Terrestrial

Nioi (Eugenia koolauensis) E Dicot Yes

(Eugenia koolauensis) Terrestrial

Nohoanu (Geranium multiflorum) E Dicot Yes

(Geranium multiflorum) Terrestrial

'Oha (Delissea rivularis) E Dicot Yes

(Delissea rivularis) Terrestrial

'Oha (Delissea subcordata) E Dicot Yes

(Delissea subcordata) Terrestrial

'Oha (Delissea undulata) E Dicot Yes

(Delissea undulata) Terrestrial

'Oha (Lobelia gaudichaudii koolauensis) E Dicot Yes

(Lobelia gaudichaudii ssp. koolauensis) Terrestrial

'Oha Wai (Clermontia drepanomorpha) E Dicot Yes

(Clermontia drepanomorpha) Terrestrial

'Oha Wai (Clermontia lindseyana) E Dicot Yes

(Clermontia lindseyana) Terrestrial

'Oha Wai (Clermontia oblongifolia ssp. brevipes) E Dicot Yes

(Clermontia oblongifolia ssp. brevipes) Terrestrial

'Oha Wai (Clermontia oblongifolia ssp. mauiensis) E Dicot Yes

(Clermontia oblongifolia ssp. mauiensis) Terrestrial

'Oha Wai (Clermontia peleana) E Dicot Yes

(Clermontia peleana) Terrestrial

'Oha Wai (Clermontia pyrularia) E Dicot Yes

(Clermontia pyrularia) Terrestrial
Page 54 of 216 

'Oha Wai (Clermontia samuelii) E Dicot Yes

(Clermontia samuelii) Terrestrial

'Ohai (Sesbania tomentosa) E Dicot Yes

(Sesbania tomentosa) Terrestrial

'Ohe'ohe (Tetraplasandra gymnocarpa) E Dicot Yes

(Tetraplasandra gymnocarpa) Terrestrial

'Olulu (Brighamia insignis) E Dicot Yes

(Brighamia insignis) Terrestrial

Opuhe (Urera kaalae) E Dicot Yes

(Urera kaalae) Terrestrial

Pamakani (Viola chamissoniana ssp. chamissoniana) E Dicot Yes

(Viola chamissoniana ssp. chamissoniana) Terrestrial

Phyllostegia hirsuta (ncn) E Dicot Yes

(Phyllostegia hirsuta) Terrestrial

Phyllostegia kaalaensis (ncn) E Dicot Yes

(Phyllostegia kaalaensis) Terrestrial

Phyllostegia knudsenii (ncn) E Dicot Yes

(Phyllostegia knudsenii) Terrestrial

Phyllostegia mannii (ncn) E Dicot Yes

(Phyllostegia mannii) Terrestrial

Phyllostegia mollis (ncn) E Dicot Yes

(Phyllostegia mollis) Terrestrial

Phyllostegia parviflora (ncn) E Dicot Yes

(Phyllostegia parviflora) Terrestrial

Phyllostegia velutina (ncn) E Dicot Yes

(Phyllostegia velutina) Terrestrial

Phyllostegia waimeae (ncn) E Dicot Yes

(Phyllostegia waimeae) Terrestrial

Phyllostegia warshaueri (ncn) E Dicot Yes

(Phyllostegia warshaueri) Terrestrial

Phyllostegia wawrana (ncn) E Dicot Yes

(Phyllostegia wawrana) Terrestrial

Pilo (Hedyotis mannii) E Dicot Yes

(Hedyotis mannii) Terrestrial

Po'e (Portulaca sclerocarpa) E Dicot Yes

(Portulaca sclerocarpa) Terrestrial

Popolo 'Aiakeakua (Solanum sandwicense) E Dicot Yes

(Solanum sandwicense) Terrestrial

Popolo Ku Mai (Solanum incompletum) E Dicot Yes

(Solanum incompletum) Terrestrial

Pua'ala (Brighamia rockii) E Dicot Yes

(Brighamia rockii) Terrestrial

Remya kauaiensis (ncn) E Dicot Yes

(Remya kauaiensis) Terrestrial

Remya montgomeryi (ncn) E Dicot Yes

(Remya montgomeryi) Terrestrial

Remya, Maui E Dicot Yes

(Remya mauiensis) Terrestrial

Sandalwood, Lanai (='Iliahi) E Dicot No

(Santalum freycinetianum var. lanaiense) Terrestrial

Sanicula mariversa (ncn) E Dicot Yes

(Sanicula mariversa) Terrestrial
Page 55 of 216 

Sanicula purpurea (ncn) E Dicot Yes

(Sanicula purpurea) Terrestrial

Schiedea haleakalensis (ncn) E Dicot Yes

(Schiedea haleakalensis) Terrestrial

Schiedea helleri (ncn) E Dicot Yes

(Schiedea helleri) Terrestrial

Schiedea hookeri (ncn) E Dicot Yes

(Schiedea hookeri) Terrestrial

Schiedea kaalae (ncn) E Dicot Yes

(Schiedea kaalae) Terrestrial

Schiedea kauaiensis (ncn) E Dicot Yes

(Schiedea kauaiensis) Terrestrial

Schiedea lydgatei (ncn) E Dicot Yes

(Schiedea lydgatei) Terrestrial

Schiedea membranacea (ncn) E Dicot Yes

(Schiedea membranacea) Terrestrial

Schiedea nuttallii (ncn) E Dicot Yes

(Schiedea nuttallii) Terrestrial

Schiedea sarmentosa (ncn) E Dicot Yes

(Schiedea sarmentosa) Terrestrial

Schiedea spergulina var. leiopoda (ncn) E Dicot Yes

(Schiedea spergulina var. leiopoda) Terrestrial

Schiedea spergulina var. spergulina (ncn) T Dicot Yes

(Schiedea spergulina var. spergulina) Terrestrial

Schiedea verticillata (ncn) E Dicot Yes

(Schiedea verticillata) Terrestrial

Schiedea, Diamond Head (Schiedea adamantis) E Dicot No

(Schiedea adamantis) Terrestrial

Silene alexandri (ncn) E Dicot Yes

(Silene alexandri) Terrestrial

Silene hawaiiensis (ncn) T Dicot Yes

(Silene hawaiiensis) Terrestrial

Silene lanceolata (ncn) E Dicot Yes

(Silene lanceolata) Terrestrial

Silene perlmanii (ncn) E Dicot Yes

(Silene perlmanii) Terrestrial

Silversword, Haleakala ('Ahinahina) T Dicot Yes

(Argyroxiphium sandwicense ssp. macrocephalum) Terrestrial

Silversword, Ka'u (Argyroxiphium kauense) E Dicot Yes

(Argyroxiphium kauense) Terrestrial

Silversword, Mauna Kea ('Ahinahina) E Dicot No

(Argyroxiphium sandwicense ssp. sandwicense) Terrestrial

Spermolepis hawaiiensis (ncn) E Dicot Yes

(Spermolepis hawaiiensis) Terrestrial

Stenogyne angustifolia (ncn) E Dicot No

(Stenogyne angustifolia var. angustifolia) Terrestrial

Stenogyne bifida (ncn) E Dicot Yes

(Stenogyne bifida) Terrestrial

Stenogyne campanulata (ncn) E Dicot Yes

(Stenogyne campanulata) Terrestrial

Stenogyne kanehoana (ncn) E Dicot Yes

(Stenogyne kanehoana) Terrestrial
Page 56 of 216 

Tetramolopium arenarium (ncn) E Dicot No

(Tetramolopium arenarium) Terrestrial

Tetramolopium capillare (ncn) E Dicot Yes

(Tetramolopium capillare) Terrestrial

Tetramolopium filiforme (ncn) E Dicot Yes

(Tetramolopium filiforme) Terrestrial

Tetramolopium lepidotum ssp. lepidotum (ncn) E Dicot Yes

(Tetramolopium lepidotum ssp. lepidotum) Terrestrial

Tetramolopium remyi (ncn) E Dicot Yes

(Tetramolopium remyi) Terrestrial

Tetramolopium rockii (ncn) T Dicot Yes

(Tetramolopium rockii) Terrestrial, Coastal

Trematolobelia singularis (ncn) E Dicot Yes

(Trematolobelia singularis) Terrestrial

Uhiuhi (Caesalpinia kavaiensis) E Dicot No

(Caesalpinia kavaiense) Terrestrial

Ulihi (Phyllostegia glabra var. lanaiensis) E Dicot No

(Phyllostegia glabra var. lanaiensis) Terrestrial

Vetch, Hawaiian (Vicia menziesii) E Dicot No

(Vicia menziesii) Terrestrial

Vigna o-wahuensis (ncn) E Dicot Yes

(Vigna o-wahuensis) Terrestrial

Viola helenae (ncn) E Dicot Yes

(Viola helenae) Terrestrial

Viola lanaiensis (ncn) E Dicot No

(Viola lanaiensis) Terrestrial

Viola oahuensis (ncn) E Dicot Yes

(Viola oahuensis) Terrestrial

Wahine Noho Kula (Isodendrion pyrifolium) E Dicot Yes

(Isodendrion pyrifolium) Terrestrial

Xylosma crenatum (ncn) E Dicot Yes

(Xylosma crenatum) Terrestrial

Asplenium fragile var. insulare (ncn) E Ferns Yes

(Asplenium fragile var. insulare) Terrestrial

Diellia erecta (ncn) E Ferns Yes

(Diellia erecta) Terrestrial

Diellia falcata (ncn) E Ferns Yes

(Diellia falcata) Terrestrial

Diellia pallida (ncn) E Ferns Yes

(Diellia pallida) Terrestrial

Diellia unisora (ncn) E Ferns Yes

(Diellia unisora) Terrestrial

Diplazium molokaiense (ncn) E Ferns Yes

(Diplazium molokaiense) Terrestrial

Fern, Pendant Kihi (Adenophorus periens) E Ferns Yes

(Adenophorus periens) Terrestrial

'Ihi'Ihi (Marsilea villosa) E Ferns Yes

(Marsilea villosa) Terrestrial, Vernal pool

Pauoa (Ctenitis squamigera) E Ferns Yes

(Ctenitis squamigera) Terrestrial

Pteris lidgatei (ncn) E Ferns Yes

(Pteris lidgatei) Terrestrial
Page 57 of 216 

Wawae'Iole (Phlegmariurus (=Huperzia) mannii) E Ferns Yes

(Huperzia mannii) Terrestrial

Wawae'Iole (Phlegmariurus (=Lycopodium) nutans) E Ferns Yes

(Lycopodium (=Phlegmariurus) nutans) Terrestrial

Snail, Newcomb's T Gastropod Yes

(Erinna newcombi) Freshwater

Fly, Hawaiian picture-wing E Insect No

(Drosophila neoclavisetae) Terrestrial

Fly, Hawaiian picture-wing E Insect No

(Drosophila heteroneura) Terrestrial

Fly, Hawaiian picture-wing E Insect No

(Drosophila tarphytrichia) Terrestrial

Fly, Hawaiian picture-wing E Insect No

(Drosophila ochrobasis) Terrestrial

Fly, Hawaiian picture-wing E Insect No

(Drosophila musaphilia) Terrestrial

Fly, Hawaiian picture-wing T Insect No

(Drosophila mulli) Terrestrial

Moth, Blackburn's Sphinx E Insect Yes

(Manduca blackburni) Terrestrial

Bat, Hawaiian Hoary E Mammal No

(Lasiurus cinereus semotus) Terrestrial, Subterraneous

Seal, Hawaiian Monk E Marine mml Yes

(Monachus schauinslandi) Saltwater, Coastal

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Bluegrass, Hawaiian E Monocot Yes

(Poa sandvicensis) Terrestrial

Bluegrass, Mann's (Poa mannii) E Monocot Yes

(Poa mannii) Terrestrial

Gahnia Lanaiensis (ncn) E Monocot No

(Gahnia lanaiensis) Terrestrial

Grass, Fosberg's Love E Monocot Yes

(Eragrostis fosbergii) Terrestrial

Hala Pepe (Pleomele hawaiiensis) E Monocot Yes

(Pleomele hawaiiensis) Terrestrial

Hilo Ischaemum (Ischaemum byrone) E Monocot Yes

(Ischaemum byrone) Terrestrial

Kamanomano (Cenchrus agrimonioides) E Monocot Yes

(Cenchrus agrimonioides) Terrestrial

Lau'ehu (Panicum niihauense) E Monocot Yes

(Panicum niihauense) Terrestrial

Lo`ulu (Pritchardia affinis) E Monocot No

(Pritchardia affinis) Terrestrial

Lo`ulu (Pritchardia kaalae) E Monocot No

(Pritchardia kaalae) Terrestrial

Lo`ulu (Pritchardia munroi) E Monocot Yes

(Pritchardia munroi) Terrestrial

Lo`ulu (Pritchardia napaliensis) E Monocot No

(Pritchardia napaliensis) Terrestrial

Lo`ulu (Pritchardia remota) E Monocot Yes

(Pritchardia remota) Terrestrial
Page 58 of 216 

Lo`ulu (Pritchardia schattaueri) E Monocot No

(Pritchardia schattaueri) Terrestrial

Lo`ulu (Pritchardia viscosa) E Monocot No

(Pritchardia viscosa) Terrestrial

Mariscus fauriei (ncn) E Monocot Yes

(Mariscus fauriei) Terrestrial

Mariscus pennatiformis (ncn) E Monocot Yes

(Mariscus pennatiformis) Terrestrial

Panicgrass, Carter's (Panicum fauriei var.carteri) E Monocot Yes

(Panicum fauriei var. carteri) Terrestrial

Platanthera holochila (ncn) E Monocot Yes

(Platanthera holochila) Terrestrial

Poa siphonoglossa (ncn) E Monocot Yes

(Poa siphonoglossa) Terrestrial

Pu'uka'a (Cyperus trachysanthos) E Monocot Yes

(Cyperus trachysanthos) Terrestrial

Wahane (Pritchardia aylmer-robinsonii) E Monocot No

(Pritchardia aylmer-robinsonii) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Idaho ( 16) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Catchfly, Spalding's T Dicot No

(Silene spaldingii) Terrestrial

Four-o'clock, Macfarlane's T Dicot No

(Mirabilis macfarlanei) Terrestrial

Howellia, Water T Dicot No

(Howellia aquatilis) Freshwater

Salmon, Sockeye E Fish No

(Oncorhynchus (=Salmo) nerka) Freshwater, Brackish, Saltwater

Steelhead E Fish Yes

(Oncorhynchus (=Salmo) mykiss) Freshwater, Brackish, Saltwater

Sturgeon, White E Fish Yes

(Acipenser transmontanus) Freshwater, Saltwater

Trout, Bull T Fish Yes

(Salvelinus confluentus) Freshwater

Limpet, Banbury Springs E Gastropod No

(Lanx sp.) Freshwater

Snail, Bliss Rapids T Gastropod No

(Taylorconcha serpenticola) Freshwater

Snail, Snake River Physa E Gastropod No

(Physa natricina) Terrestrial

Snail, Utah Valvata E Gastropod No

(Valvata utahensis) Terrestrial

Springsnail, Bruneau Hot E Gastropod No
Page 59 of 216 

(Pyrgulopsis bruneauensis) Freshwater

Bear, Grizzly T Mammal No

(Ursus arctos horribilis) Terrestrial

Caribou, Woodland E Mammal No

(Rangifer tarandus caribou) Terrestrial

Squirrel, Northern Idaho Ground T Mammal No

(Spermophilus brunneus brunneus) Terrestrial

Illinois ( 25) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pearlymussel, Higgins' Eye E Bivalve No

(Lampsilis higginsii) Freshwater

Pearlymussel, Orange-footed E Bivalve No

(Plethobasus cooperianus) Freshwater

Pearlymussel, White Wartyback E Bivalve No

(Plethobasus cicatricosus) Freshwater

Amphipod, Illinois Cave E Crustacean No

(Gammarus acherondytes) Freshwater, Subterraneous

Aster, Decurrent False T Dicot No

(Boltonia decurrens) Terrestrial, Freshwater

Clover, Leafy Prairie E Dicot No

(Dalea foliosa) Terrestrial

Clover, Prairie Bush T Dicot No

(Lespedeza leptostachya) Terrestrial

Daisy, Lakeside T Dicot No

(Hymenoxys herbacea) Freshwater

Milkweed, Mead's T Dicot No

(Asclepias meadii) Terrestrial

Potato-bean, Price's T Dicot No

(Apios priceana) Terrestrial

Thistle, Pitcher's T Dicot No

(Cirsium pitcheri) Terrestrial

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Snail, Iowa Pleistocene E Gastropod No

(Discus macclintocki) Terrestrial

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Dragonfly, Hine's Emerald E Insect Yes

(Somatochlora hineana) Terrestrial, Freshwater

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous
Page 60 of 216 

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Indiana ( 23) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Mussel, Ring Pink (=Golf Stick Pearly) E Bivalve No

(Obovaria retusa) Freshwater

Mussel, Rough Pigtoe E Bivalve No

(Pleurobema plenum) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pearlymussel, Orange-footed E Bivalve No

(Plethobasus cooperianus) Freshwater

Pearlymussel, Tubercled-blossom E Bivalve No

(Epioblasma torulosa torulosa) Freshwater

Pearlymussel, White Cat's Paw E Bivalve No

(Epioblasma obliquata perobliqua) Freshwater

Pearlymussel, White Wartyback E Bivalve No

(Plethobasus cicatricosus) Freshwater

Riffleshell, Northern E Bivalve No

(Epioblasma torulosa rangiana) Freshwater

Clover, Running Buffalo E Dicot No

(Trifolium stoloniferum) Terrestrial

Goldenrod, Short's E Dicot No

(Solidago shortii) Terrestrial

Milkweed, Mead's T Dicot No

(Asclepias meadii) Terrestrial

Thistle, Pitcher's T Dicot No

(Cirsium pitcheri) Terrestrial

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Butterfly, Mitchell's Satyr E Insect No

(Neonympha mitchellii mitchellii) Terrestrial, Perm. wetland

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Snake, Northern Copperbelly Water T Reptile No
Page 61 of 216 

(Nerodia erythrogaster neglecta) Terrestrial, Freshwater

Iowa ( 14) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pearlymussel, Higgins' Eye E Bivalve No

(Lampsilis higginsii) Freshwater

Clover, Prairie Bush T Dicot No

(Lespedeza leptostachya) Terrestrial

Milkweed, Mead's T Dicot No

(Asclepias meadii) Terrestrial

Monkshood, Northern Wild T Dicot No

(Aconitum noveboracense) Terrestrial

Fern, American hart's-tongue T Ferns No

(Asplenium scolopendrium var. americanum) Terrestrial

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Snail, Iowa Pleistocene E Gastropod No

(Discus macclintocki) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Kansas ( 12) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Milkweed, Mead's T Dicot No

(Asclepias meadii) Terrestrial

Madtom, Neosho T Fish No

(Noturus placidus) Freshwater

Shiner, Arkansas River T Fish Yes

(Notropis girardi) Freshwater

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Ferret, Black-footed E Mammal No
Page 62 of 216 

(Mustela nigripes) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Kentucky ( 49) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Warbler (=Wood), Kirtland's E Bird No

(Dendroica kirtlandii) Terrestrial

Warbler, Bachman's E Bird No

(Vermivora bachmanii) Terrestrial

Woodpecker, Ivory-billed E Bird No

(Campephilus principalis) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Mussel, Cumberland Combshell E Bivalve Yes

(Epioblasma brevidens) Freshwater

Mussel, Cumberland Elktoe E Bivalve Yes

(Alasmidonta atropurpurea) Freshwater

Mussel, Oyster E Bivalve Yes

(Epioblasma capsaeformis) Freshwater

Mussel, Ring Pink (=Golf Stick Pearly) E Bivalve No

(Obovaria retusa) Freshwater

Mussel, Rough Pigtoe E Bivalve No

(Pleurobema plenum) Freshwater

Mussel, Winged Mapleleaf E Bivalve No

(Quadrula fragosa) Freshwater

Pearlymussel, Appalachian Monkeyface E Bivalve No

(Quadrula sparsa) Freshwater

Pearlymussel, Cracking E Bivalve No

(Hemistena lata) Freshwater

Pearlymussel, Cumberland Bean E Bivalve No

(Villosa trabalis) Freshwater

Pearlymussel, Dromedary E Bivalve No

(Dromus dromas) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pearlymussel, Little-wing E Bivalve No

(Pegias fabula) Freshwater

Pearlymussel, Orange-footed E Bivalve No

(Plethobasus cooperianus) Freshwater

Pearlymussel, Purple Cat's Paw E Bivalve No

(Epioblasma obliquata obliquata) Freshwater

Pearlymussel, Tubercled-blossom E Bivalve No

(Epioblasma torulosa torulosa) Freshwater
Page 63 of 216 

Pearlymussel, White Wartyback E Bivalve No

(Plethobasus cicatricosus) Freshwater

Pearlymussel, Yellow-blossom E Bivalve No

(Epioblasma florentina florentina) Freshwater

Riffleshell, Northern E Bivalve No

(Epioblasma torulosa rangiana) Freshwater

Riffleshell, Tan E Bivalve No

(Epioblasma florentina walkeri (=E. walkeri)) Freshwater

Shrimp, Kentucky Cave E Crustacean Yes

(Palaemonias ganteri) Freshwater

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Clover, Running Buffalo E Dicot No

(Trifolium stoloniferum) Terrestrial

Goldenrod, Short's E Dicot No

(Solidago shortii) Terrestrial

Goldenrod, White-haired T Dicot No

(Solidago albopilosa) Terrestrial

Potato-bean, Price's T Dicot No

(Apios priceana) Terrestrial

Rock-cress, Braun's E Dicot Yes

(Arabis perstellata E. L. Braun var. ampla Rollins) Terrestrial

Rock-cress, Small E Dicot Yes

(Arabis perstellata E. L. Braun var. perstellata Fernald) Terrestrial

Rosemary, Cumberland T Dicot No

(Conradina verticillata) Terrestrial

Sandwort, Cumberland E Dicot No

(Arenaria cumberlandensis) Terrestrial

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Dace, Blackside T Fish No

(Phoxinus cumberlandensis) Freshwater

Darter, Bluemask (=jewel) E Fish No

(Etheostoma sp.) Freshwater

Darter, Relict E Fish No

(Etheostoma chienense) Freshwater

Shiner, Palezone E Fish No

(Notropis albizonatus) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Virginia Big-eared E Mammal Yes

(Corynorhinus (=Plecotus) townsendii virginianus) Terrestrial, Subterraneous

Wolf, Red E Mammal No

(Canis rufus) Terrestrial

Louisiana ( 25) species: Taxa Critical Habitat

Pelican, Brown E Bird No
Page 64 of 216 

(Pelecanus occidentalis) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, California Least E Bird No

(Sterna antillarum browni) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Heelsplitter Inflated T Bivalve No

(Potamilus inflatus) Freshwater

Pearlshell, Louisiana T Bivalve No

(Margaritifera hembeli) Freshwater

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Fruit, Earth (=geocarpon) T Dicot No

(Geocarpon minimum) Terrestrial

Quillwort, Louisiana E Ferns No

(Isoetes louisianensis) Terrestrial, Freshwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Bear, Louisiana Black T Mammal No

(Ursus americanus luteolus) Terrestrial

Jaguar E Mammal No

(Panthera onca) Terrestrial

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Tortoise, Gopher T Reptile No

(Gopherus polyphemus) Terrestrial

Turtle, Ringed Sawback T Reptile No

(Graptemys oculifera) Terrestrial, Freshwater

Maine ( 12) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial
Page 65 of 216 

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Lousewort, Furbish E Dicot No

(Pedicularis furbishiae) Terrestrial

Salmon, Atlantic E Fish No

(Salmo salar) Freshwater, Brackish, Saltwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Lynx, Canada T Mammal No

(Lynx canadensis) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Maryland ( 22) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Dropwort, Canby's E Dicot No

(Oxypolis canbyi) Terrestrial, Freshwater

Gerardia, Sandplain E Dicot No

(Agalinis acuta) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Joint-vetch, Sensitive T Dicot No

(Aeschynomene virginica) Terrestrial, Brackish

Darter, Maryland E Fish Yes

(Etheostoma sellare) Freshwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Beetle, Northeastern Beach Tiger T Insect No

(Cicindela dorsalis dorsalis) Terrestrial

Beetle, Puritan Tiger T Insect No

(Cicindela puritana) Terrestrial, Coastal

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Squirrel, Delmarva Peninsula Fox E Mammal No

(Sciurus niger cinereus) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes
Page 66 of 216 

(Eubalaena glacialis (incl. australis)) Saltwater

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

Massachusetts ( 18) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Gerardia, Sandplain E Dicot No

(Agalinis acuta) Terrestrial

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Beetle, Northeastern Beach Tiger T Insect No

(Cicindela dorsalis dorsalis) Terrestrial

Beetle, Puritan Tiger T Insect No

(Cicindela puritana) Terrestrial, Coastal

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

Turtle, Plymouth Red-bellied E Reptile Yes

(Pseudemys rubriventris bangsi) Terrestrial, Freshwater
Page 67 of 216 

Michigan ( 19) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Warbler (=Wood), Kirtland's E Bird No

(Dendroica kirtlandii) Terrestrial

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Riffleshell, Northern E Bivalve No

(Epioblasma torulosa rangiana) Freshwater

Daisy, Lakeside T Dicot No

(Hymenoxys herbacea) Freshwater

Goldenrod, Houghton's T Dicot No

(Solidago houghtonii) Terrestrial

Monkey-flower, Michigan E Dicot No

(Mimulus glabratus var. michiganensis) Terrestrial, Freshwater

Thistle, Pitcher's T Dicot No

(Cirsium pitcheri) Terrestrial

Fern, American hart's-tongue T Ferns No

(Asplenium scolopendrium var. americanum) Terrestrial

Beetle, Hungerford's Crawling Water E Insect No

(Brychius hungerfordi) Freshwater

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Butterfly, Mitchell's Satyr E Insect No

(Neonympha mitchellii mitchellii) Terrestrial, Perm. wetland

Dragonfly, Hine's Emerald E Insect Yes

(Somatochlora hineana) Terrestrial, Freshwater

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Lynx, Canada T Mammal No

(Lynx canadensis) Terrestrial

Iris, Dwarf Lake T Monocot No

(Iris lacustris) Terrestrial

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Snake, Northern Copperbelly Water T Reptile No

(Nerodia erythrogaster neglecta) Terrestrial, Freshwater

Minnesota ( 10) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Mussel, Winged Mapleleaf E Bivalve No

(Quadrula fragosa) Freshwater

Pearlymussel, Higgins' Eye E Bivalve No

(Lampsilis higginsii) Freshwater

Clover, Prairie Bush T Dicot No

(Lespedeza leptostachya) Terrestrial

Roseroot, Leedy's T Dicot No

(Sedum integrifolium ssp. leedyi) Terrestrial

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater
Page 68 of 216 

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Lynx, Canada T Mammal No

(Lynx canadensis) Terrestrial

Lily, Minnesota Trout E Monocot No

(Erythronium propullans) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Mississippi ( 35) species: Taxa Critical Habitat

Frog, Dusky Gopher (Mississippi DPS) E Amphibian No

(Rana capito sevosa) Terrestrial, Freshwater

Crane, Mississippi Sandhill E Bird Yes

(Grus canadensis pulla) Terrestrial, Freshwater

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Combshell, Southern (=Penitent mussel) E Bivalve No

(Epioblasma penita) Freshwater

Mucket, Orangenacre T Bivalve Yes

(Lampsilis perovalis) Freshwater

Mussel, Alabama Moccasinshell T Bivalve Yes

(Medionidus acutissimus) Freshwater

Mussel, Black (=Curtus' Mussel) Clubshell E Bivalve No

(Pleurobema curtum) Freshwater

Mussel, Heavy Pigtoe (=Judge Tait's Mussel) E Bivalve No

(Pleurobema taitianum) Freshwater

Mussel, Heelsplitter Inflated T Bivalve No

(Potamilus inflatus) Freshwater

Mussel, Ovate Clubshell E Bivalve Yes

(Pleurobema perovatum) Freshwater

Mussel, Southern Clubshell E Bivalve Yes

(Pleurobema decisum) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Potato-bean, Price's T Dicot No

(Apios priceana) Terrestrial

Quillwort, Louisiana E Ferns No

(Isoetes louisianensis) Terrestrial, Freshwater

Darter, Bayou T Fish No

(Etheostoma rubrum) Freshwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Bat, Gray E Mammal No
Page 69 of 216 

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bear, Louisiana Black T Mammal No

(Ursus americanus luteolus) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Snake, Eastern Indigo T Reptile Yes

(Drymarchon corais couperi) Terrestrial

Tortoise, Gopher T Reptile No

(Gopherus polyphemus) Terrestrial

Turtle, Ringed Sawback T Reptile No

(Graptemys oculifera) Terrestrial, Freshwater

Turtle, Yellow-blotched Map T Reptile No

(Graptemys flavimaculata) Terrestrial, Freshwater

Missouri ( 29) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Scaleshell E Bivalve No

(Leptodea leptodon) Freshwater

Mussel, Winged Mapleleaf E Bivalve No

(Quadrula fragosa) Freshwater

Pearlymussel, Curtis' E Bivalve No

(Epioblasma florentina curtisii) Freshwater

Pearlymussel, Fat Pocketbook E Bivalve No

(Potamilus capax) Freshwater

Pearlymussel, Higgins' Eye E Bivalve No

(Lampsilis higginsii) Freshwater

Crayfish, Cave (Cambarus aculabrum) E Crustacean No

(Cambarus aculabrum) Freshwater

Aster, Decurrent False T Dicot No

(Boltonia decurrens) Terrestrial, Freshwater

Bladderpod, Missouri T Dicot No

(Lesquerella filiformis) Terrestrial

Clover, Running Buffalo E Dicot No

(Trifolium stoloniferum) Terrestrial
Page 70 of 216 

Fruit, Earth (=geocarpon) T Dicot No

(Geocarpon minimum) Terrestrial

Milkweed, Mead's T Dicot No

(Asclepias meadii) Terrestrial

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Sneezeweed, Virginia T Dicot No

(Helenium virginicum) Vernal pool

Cavefish, Ozark T Fish No

(Amblyopsis rosae) Freshwater

Chub, Humpback E Fish Yes

(Gila cypha) Freshwater

Darter, Niangua T Fish Yes

(Etheostoma nianguae) Freshwater

Madtom, Neosho T Fish No

(Noturus placidus) Freshwater

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater

Sturgeon, Gulf T Fish Yes

(Acipenser oxyrinchus desotoi) Freshwater, Saltwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Cavesnail, Tumbling Creek E Gastropod No

(Antrobia culveri) Freshwater, Subterraneous

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Dragonfly, Hine's Emerald E Insect Yes

(Somatochlora hineana) Terrestrial, Freshwater

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Montana ( 10) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Catchfly, Spalding's T Dicot No

(Silene spaldingii) Terrestrial

Howellia, Water T Dicot No

(Howellia aquatilis) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Sturgeon, White E Fish Yes

(Acipenser transmontanus) Freshwater, Saltwater

Trout, Bull T Fish Yes

(Salvelinus confluentus) Freshwater

Bear, Grizzly T Mammal No
Page 71 of 216 

(Ursus arctos horribilis) Terrestrial

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Nebraska ( 10) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Butterfly Plant, Colorado T Dicot Yes

(Gaura neomexicana var. coloradensis) Terrestrial

Penstemon, Blowout E Dicot No

(Penstemon haydenii) Terrestrial

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Beetle, Salt Creek Tiger E Insect No

(Cicindela nevadica lincolniana) Terrestrial

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Nevada ( 24) species: Taxa Critical Habitat

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Rail, Yuma Clapper E Bird No

(Rallus longirostris yumanensis) Terrestrial

Blazing Star, Ash Meadows T Dicot Yes

(Mentzelia leucophylla) Terrestrial

Centaury, Spring-loving T Dicot Yes

(Centaurium namophilum) Terrestrial

Gumplant, Ash Meadows T Dicot Yes

(Grindelia fraxino-pratensis) Terrestrial

Ivesia, Ash Meadows T Dicot Yes

(Ivesia kingii var. eremica) Terrestrial

Milk-vetch, Ash Meadows T Dicot Yes

(Astragalus phoenix) Terrestrial

Niterwort, Amargosa E Dicot Yes

(Nitrophila mohavensis) Terrestrial

Sunray, Ash Meadows T Dicot Yes

(Enceliopsis nudicaulis var. corrugata) Terrestrial

Chub, Bonytail E Fish Yes

(Gila elegans) Freshwater

Chub, Virgin River E Fish Yes

(Gila seminuda (=robusta)) Freshwater

Dace, Ash Meadows Speckled E Fish Yes

(Rhinichthys osculus nevadensis) Freshwater

Dace, Moapa E Fish No

(Moapa coriacea) Freshwater

Poolfish, Pahrump (= Pahrump Killifish) E Fish No
Page 72 of 216 

(Empetrichthys latos) Freshwater

Pupfish, Ash Meadows Amargosa E Fish Yes

(Cyprinodon nevadensis mionectes) Freshwater

Pupfish, Devils Hole E Fish No

(Cyprinodon diabolis) Freshwater

Pupfish, Warm Springs E Fish No

(Cyprinodon nevadensis pectoralis) Freshwater

Spinedace, White River E Fish Yes

(Lepidomeda albivallis) Freshwater

Springfish, Railroad Valley T Fish Yes

(Crenichthys nevadae) Freshwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Trout, Lahontan Cutthroat T Fish No

(Oncorhynchus clarki henshawi) Freshwater

Woundfin E Fish Yes

(Plagopterus argentissimus) Freshwater

Naucorid, Ash Meadows T Insect Yes

(Ambrysus amargosus) Terrestrial

Tortoise, Desert T Reptile Yes

(Gopherus agassizii) Terrestrial

New Hampshire ( 7) species: Taxa Critical Habitat

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Milk-vetch, Jesup's E Dicot No

(Astragalus robbinsii var. jesupi) Terrestrial

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

New Jersey ( 17) species: Taxa Critical Habitat

Curlew, Eskimo E Bird No

(Numenius borealis) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Joint-vetch, Sensitive T Dicot No

(Aeschynomene virginica) Terrestrial, Brackish

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No
Page 73 of 216 

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Beaked-rush, Knieskern's T Monocot No

(Rhynchospora knieskernii) Terrestrial

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

New Mexico ( 45) species: Taxa Critical Habitat

Frog, Chiricahua Leopard T Amphibian No

(Rana chiricahuensis) Terrestrial, Freshwater

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Falcon, Northern Aplomado E Bird No

(Falco femoralis septentrionalis) Terrestrial

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Owl, Mexican Spotted T Bird Yes

(Strix occidentalis lucida) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Amphipod, Noel's E Crustacean Yes

(Gammarus desperatus) Freshwater

Isopod, Socorro E Crustacean No

(Thermosphaeroma thermophilus) Freshwater

Cactus, Knowlton E Dicot No

(Pediocactus knowltonii) Terrestrial

Cactus, Kuenzler Hedgehog E Dicot No

(Echinocereus fendleri var. kuenzleri) Terrestrial

Cactus, Lee Pincushion T Dicot No

(Coryphantha sneedii var. leei) Terrestrial

Cactus, Mesa Verde T Dicot No

(Sclerocactus mesae-verdae) Terrestrial

Cactus, Sneed Pincushion E Dicot No

(Coryphantha sneedii var. sneedii) Terrestrial

Fleabane, Zuni T Dicot No

(Erigeron rhizomatus) Terrestrial

Ipomopsis, Holy Ghost E Dicot No

(Ipomopsis sancti-spiritus) Terrestrial
Page 74 of 216 

Milk-vetch, Mancos E Dicot No

(Astragalus humillimus) Terrestrial

Pennyroyal, Todsen's E Dicot Yes

(Hedeoma todsenii) Terrestrial

Poppy, Sacramento Prickly E Dicot No

(Argemone pleiacantha ssp. pinnatisecta) Terrestrial

Sunflower, Pecos T Dicot Yes

(Helianthus paradoxus) Terrestrial, Perm. wetland

Thistle, Sacramento Mountains T Dicot No

(Cirsium vinaceum) Terrestrial

Wild-buckwheat, Gypsum T Dicot Yes

(Eriogonum gypsophilum) Terrestrial

Chub, Chihuahua T Fish No

(Gila nigrescens) Freshwater

Chub, Gila E Fish Yes

(Gila intermedia) Freshwater

Gambusia, Pecos E Fish No

(Gambusia nobilis) Freshwater

Minnow, Loach T Fish Yes

(Tiaroga cobitis) Freshwater

Minnow, Rio Grande Silvery E Fish Yes

(Hybognathus amarus) Freshwater

Shiner, Arkansas River T Fish Yes

(Notropis girardi) Freshwater

Shiner, Beautiful T Fish Yes

(Cyprinella formosa) Freshwater

Shiner, Pecos Bluntnose T Fish Yes

(Notropis simus pecosensis) Freshwater

Spikedace T Fish Yes

(Meda fulgida) Freshwater

Squawfish, Colorado E Fish Yes

(Ptychocheilus lucius) Freshwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Topminnow, Gila (Yaqui) E Fish No

(Poeciliopsis occidentalis) Freshwater

Trout, Gila E Fish No

(Oncorhynchus gilae) Freshwater

Snail, Pecos Assiminea E Gastropod Yes

(Assiminea pecos) Freshwater

Springsnail, Alamosa E Gastropod No

(Tryonia alamosae) Freshwater

Springsnail, Koster's E Gastropod No

(Juturnia kosteri) Terrestrial

Springsnail, Roswell E Gastropod Yes

(Pyrgulopsis roswellensis) Freshwater

Springsnail, Socorro E Gastropod No

(Pyrgulopsis neomexicana) Freshwater

Bat, Lesser (=Sanborn's) Long-nosed E Mammal No

(Leptonycteris curasoae yerbabuenae) Terrestrial, Subterraneous

Bat, Mexican Long-nosed E Mammal No

(Leptonycteris nivalis) Terrestrial, Subterraneous
Page 75 of 216 

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Jaguar E Mammal No

(Panthera onca) Terrestrial

Rattlesnake, New Mexican Ridge-nosed T Reptile Yes

(Crotalus willardi obscurus) Terrestrial

New York ( 22) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Amaranth, Seabeach T Dicot No

(Amaranthus pumilus) Coastal

Gerardia, Sandplain E Dicot No

(Agalinis acuta) Terrestrial

Monkshood, Northern Wild T Dicot No

(Aconitum noveboracense) Terrestrial

Roseroot, Leedy's T Dicot No

(Sedum integrifolium ssp. leedyi) Terrestrial

Fern, American hart's-tongue T Ferns No

(Asplenium scolopendrium var. americanum) Terrestrial

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Snail, Chittenango Ovate Amber T Gastropod No

(Succinea chittenangoensis) Terrestrial, Freshwater

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater
Page 76 of 216 

North Carolina ( 60) species: Taxa Critical Habitat

Spider, Spruce-fir Moss E Arachnid Yes

(Microhexura montivaga) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Elktoe, Appalachian E Bivalve Yes

(Alasmidonta raveneliana) Freshwater

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Mussel, Heelsplitter Carolina E Bivalve Yes

(Lasmigona decorata) Freshwater

Mussel, Oyster E Bivalve Yes

(Epioblasma capsaeformis) Freshwater

Pearlymussel, Little-wing E Bivalve No

(Pegias fabula) Freshwater

Purple Bean E Bivalve Yes

(Villosa perpurpurea) Freshwater

Spinymussel, James River E Bivalve No

(Pleurobema collina) Freshwater

Spinymussel, Tar River E Bivalve No

(Elliptio steinstansana) Freshwater

Amaranth, Seabeach T Dicot No

(Amaranthus pumilus) Coastal

Avens, Spreading E Dicot No

(Geum radiatum) Terrestrial

Bittercress, Small-anthered E Dicot No

(Cardamine micranthera) Terrestrial

Blazing Star, Heller's T Dicot No

(Liatris helleri) Terrestrial

Bluet, Roan Mountain E Dicot No

(Hedyotis purpurea var. montana) Terrestrial

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Coneflower, Smooth E Dicot No

(Echinacea laevigata) Terrestrial

Dropwort, Canby's E Dicot No

(Oxypolis canbyi) Terrestrial, Freshwater

Goldenrod, Blue Ridge T Dicot No

(Solidago spithamaea) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Heartleaf, Dwarf-flowered T Dicot No

(Hexastylis naniflora) Terrestrial

Heather, Mountain Golden T Dicot Yes

(Hudsonia montana) Terrestrial

Joint-vetch, Sensitive T Dicot No
Page 77 of 216 

(Aeschynomene virginica) Terrestrial, Brackish

Loosestrife, Rough-leaved E Dicot No

(Lysimachia asperulaefolia) Terrestrial

Meadowrue, Cooley's E Dicot No

(Thalictrum cooleyi) Terrestrial

Pitcher-plant, Green E Dicot No

(Sarracenia oreophila) Terrestrial, Freshwater

Pitcher-plant, Mountain Sweet E Dicot No

(Sarracenia rubra ssp. jonesii) Terrestrial, Freshwater

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Sumac, Michaux's E Dicot No

(Rhus michauxii) Terrestrial

Sunflower, Schweinitz's E Dicot No

(Helianthus schweinitzii) Terrestrial

Chub, Spotfin T Fish Yes

(Erimonax monachus) Freshwater

Shiner, Cape Fear E Fish Yes

(Notropis mekistocholas) Freshwater

Silverside, Waccamaw T Fish Yes

(Menidia extensa) Freshwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Snail, Noonday T Gastropod No

(Mesodon clarki nantahala) Terrestrial

Butterfly, Saint Francis' Satyr E Insect No

(Neonympha mitchellii francisci) Terrestrial

Lichen, Rock Gnome E Lichen No

(Gymnoderma lineare) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Virginia Big-eared E Mammal Yes

(Corynorhinus (=Plecotus) townsendii virginianus) Terrestrial, Subterraneous

Squirrel, Carolina Northern Flying E Mammal No

(Glaucomys sabrinus coloratus) Terrestrial

Wolf, Red E Mammal No

(Canis rufus) Terrestrial

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Arrowhead, Bunched E Monocot No

(Sagittaria fasciculata) Freshwater

Irisette, White E Monocot No
Page 78 of 216 

(Sisyrinchium dichotomum) Terrestrial

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sedge, Golden E Monocot No

(Carex lutea) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Ohio ( 22) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Pearlymussel, Purple Cat's Paw E Bivalve No

(Epioblasma obliquata obliquata) Freshwater

Pearlymussel, White Cat's Paw E Bivalve No

(Epioblasma obliquata perobliqua) Freshwater

Riffleshell, Northern E Bivalve No

(Epioblasma torulosa rangiana) Freshwater

Clover, Running Buffalo E Dicot No

(Trifolium stoloniferum) Terrestrial

Daisy, Lakeside T Dicot No

(Hymenoxys herbacea) Freshwater

Monkshood, Northern Wild T Dicot No

(Aconitum noveboracense) Terrestrial

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Madtom, Scioto E Fish No

(Noturus trautmani) Freshwater
Page 79 of 216 

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Butterfly, Mitchell's Satyr E Insect No

(Neonympha mitchellii mitchellii) Terrestrial, Perm. wetland

Dragonfly, Hine's Emerald E Insect Yes

(Somatochlora hineana) Terrestrial, Freshwater

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Snake, Lake Erie Water T Reptile No

(Nerodia sipedon insularum) Terrestrial, Freshwater

Snake, Northern Copperbelly Water T Reptile No

(Nerodia erythrogaster neglecta) Terrestrial, Freshwater

Oklahoma ( 18) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Curlew, Eskimo E Bird No

(Numenius borealis) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Vireo, Black-capped E Bird No

(Vireo atricapilla) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Mussel, Scaleshell E Bivalve No

(Leptodea leptodon) Freshwater

Rock-pocketbook, Ouachita (=Wheeler's pm) E Bivalve No

(Arkansia wheeleri) Freshwater

Cavefish, Ozark T Fish No

(Amblyopsis rosae) Freshwater

Darter, Leopard T Fish Yes

(Percina pantherina) Freshwater

Madtom, Neosho T Fish No

(Noturus placidus) Freshwater

Shiner, Arkansas River T Fish Yes

(Notropis girardi) Freshwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Ozark Big-eared E Mammal No
Page 80 of 216 

(Corynorhinus (=Plecotus) townsendii ingens) Terrestrial, Subterraneous

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Oregon ( 37) species: Taxa Critical Habitat

Murrelet, Marbled T Bird Yes

(Brachyramphus marmoratus) Terrestrial, Freshwater, Saltwater

Owl, Northern Spotted T Bird Yes

(Strix occidentalis caurina) Terrestrial

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Plover, Western Snowy T Bird Yes

(Charadrius alexandrinus nivosus) Terrestrial

Fairy Shrimp, Vernal Pool T Crustacean Yes

(Branchinecta lynchi) Vernal pool

Catchfly, Spalding's T Dicot No

(Silene spaldingii) Terrestrial

Checker-mallow, Nelson's T Dicot No

(Sidalcea nelsoniana) Terrestrial

Daisy, Willamette E Dicot Yes

(Erigeron decumbens var. decumbens) Terrestrial

Four-o'clock, Macfarlane's T Dicot No

(Mirabilis macfarlanei) Terrestrial

Lomatium, Bradshaw's E Dicot No

(Lomatium bradshawii) Terrestrial, Freshwater

Lomatium, Cook's E Dicot No

(Lomatium cookii) Vernal pool

Lupine, Kincaid's T Dicot Yes

(Lupinus sulphureus (=oreganus) ssp. kincaidii (=var. kincaidii)) Terrestrial

Meadowfoam, Large-flowered Woolly E Dicot No

(Limnanthes floccosa ssp. Grandiflora) Vernal pool

Milk-vetch, Applegate's E Dicot No

(Astragalus applegatei) Terrestrial

Popcornflower, Rough E Dicot No

(Plagiobothrys hirtus) Vernal pool

Thelypody, Howell's Spectacular T Dicot No

(Thelypodium howellii spectabilis) Terrestrial

Chub, Hutton Tui T Fish No

(Gila bicolor ssp.) Freshwater

Chub, Oregon E Fish No

(Oregonichthys crameri) Freshwater

Dace, Foskett Speckled T Fish No

(Rhinichthys osculus ssp.) Freshwater

Salmon, Chum T Fish Yes

(Oncorhynchus (=Salmo) keta) Freshwater, Brackish, Saltwater

Salmon, Sockeye E Fish No

(Oncorhynchus (=Salmo) nerka) Freshwater, Brackish, Saltwater

Steelhead E Fish Yes

(Oncorhynchus (=Salmo) mykiss) Freshwater, Brackish, Saltwater

Sucker, Lost River E Fish No

(Deltistes luxatus) Freshwater
Page 81 of 216 

Sucker, Shortnose E Fish No

(Chasmistes brevirostris) Freshwater

Sucker, Warner T Fish Yes

(Catostomus warnerensis) Freshwater

Trout, Bull T Fish Yes

(Salvelinus confluentus) Freshwater

Butterfly, Fender's Blue E Insect Yes

(Icaricia icarioides fenderi) Terrestrial

Butterfly, Oregon Silverspot T Insect Yes

(Speyeria zerene hippolyta) Terrestrial

Deer, Columbian White-tailed E Mammal No

(Odocoileus virginianus leucurus) Terrestrial

Sea-lion, Steller (eastern) T Marine mml Yes

(Eumetopias jubatus) Saltwater, Coastal

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Pacific right E Marine mml Yes

(Eubalaena japonica) Saltwater

Fritillary, Gentner's E Monocot No

(Fritillaria gentneri) Terrestrial

Lily, Western E Monocot No

(Lilium occidentale) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Pennsylvania ( 8) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Riffleshell, Northern E Bivalve No

(Epioblasma torulosa rangiana) Freshwater

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Squirrel, Delmarva Peninsula Fox E Mammal No

(Sciurus niger cinereus) Terrestrial

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Turtle, Bog (Northern population) T Reptile No

(Clemmys muhlenbergii) Terrestrial, Freshwater

Puerto Rico ( 68) species: Taxa Critical Habitat

Coqui, Golden T Amphibian Yes

(Eleutherodactylus jasperi) Terrestrial, Freshwater

Guajon T Amphibian Yes

(Eleutherodactylus cooki) Terrestrial, Freshwater

Toad, Puerto Rican Crested T Amphibian No

(Peltophryne lemur) Terrestrial, Freshwater
Page 82 of 216 

Blackbird, Yellow-shouldered E Bird Yes

(Agelaius xanthomus) Terrestrial

Hawk, Puerto Rican Broad-winged E Bird No

(Buteo platypterus brunnescens) Terrestrial

Hawk, Puerto Rican Sharp-shinned E Bird No

(Accipiter striatus venator) Terrestrial

Nightjar, Puerto Rico E Bird No

(Caprimulgus noctitherus) Terrestrial

Parrot, Puerto Rican E Bird No

(Amazona vittata) Terrestrial

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Pigeon, Puerto Rican Plain E Bird No

(Columba inornata wetmorei) Terrestrial

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Roseate E Bird No

(Sterna dougallii dougallii) Terrestrial

Auerodendron pauciflorum (ncn) E Dicot No

(Auerodendron pauciflorum) Terrestrial

Bariaco E Dicot No

(Trichilia triacantha) Terrestrial

Boxwood, Vahl's E Dicot No

(Buxus vahlii) Terrestrial

Calyptranthes Thomasiana (ncn) E Dicot No

(Calyptranthes thomasiana) Terrestrial

Capa Rosa E Dicot No

(Callicarpa ampla) Terrestrial

Catesbaea Melanocarpa (ncn) E Dicot No

(Catesbaea melanocarpa) Terrestrial

Chamaecrista glandulosa (ncn) E Dicot No

(Chamaecrista glandulosa var. mirabilis) Terrestrial

Chumbo, Higo T Dicot No

(Harrisia portoricensis) Terrestrial

Chupacallos E Dicot No

(Pleodendron macranthum) Terrestrial

Cobana Negra T Dicot No

(Stahlia monosperma) Terrestrial

Cordia bellonis (ncn) E Dicot No

(Cordia bellonis) Terrestrial

Daphnopsis hellerana (ncn) E Dicot No

(Daphnopsis hellerana) Terrestrial

Erubia E Dicot No

(Solanum drymophilum) Terrestrial

Eugenia Woodburyana E Dicot No

(Eugenia woodburyana) Terrestrial

Gesneria pauciflora (ncn) T Dicot No

(Gesneria pauciflora) Terrestrial

Goetzea, Beautiful (Matabuey) E Dicot No

(Goetzea elegans) Terrestrial

Higuero De Sierra E Dicot No

(Crescentia portoricensis) Terrestrial
Page 83 of 216 

Holly, Cook's E Dicot No

(Ilex cookii) Terrestrial

Ilex sintenisii (ncn) E Dicot No

(Ilex sintenisii) Terrestrial

Lyonia truncata var. proctorii (ncn) E Dicot No

(Lyonia truncata var. proctorii) Terrestrial

Mitracarpus Maxwelliae E Dicot No

(Mitracarpus maxwelliae) Terrestrial

Mitracarpus Polycladus E Dicot No

(Mitracarpus polycladus) Terrestrial

Myrcia Paganii E Dicot No

(Myrcia paganii) Terrestrial

Palo Colorado (Ternstroemia luquillensis) E Dicot No

(Ternstroemia luquillensis) Terrestrial

Palo de Jazmin E Dicot No

(Styrax portoricensis) Terrestrial

Palo de Nigua E Dicot No

(Cornutia obovata) Terrestrial

Palo de Ramon E Dicot No

(Banara vanderbiltii) Terrestrial

Palo de Rosa E Dicot No

(Ottoschulzia rhodoxylon) Terrestrial

Peperomia, Wheeler's E Dicot No

(Peperomia wheeleri) Terrestrial

Prickly-ash, St. Thomas E Dicot No

(Zanthoxylum thomasianum) Terrestrial

Schoepfia arenaria (ncn) T Dicot No

(Schoepfia arenaria) Terrestrial

Ternstroemia subsessilis (ncn) E Dicot No

(Ternstroemia subsessilis) Terrestrial

Uvillo E Dicot No

(Eugenia haematocarpa) Terrestrial

Vernonia Proctorii (ncn) E Dicot No

(Vernonia proctorii) Terrestrial

Walnut, Nogal E Dicot No

(Juglans jamaicensis) Terrestrial

Fern, Adiantum vivesii E Ferns No

(Adiantum vivesii) Terrestrial

Fern, Elaphoglossum serpens E Ferns No

(Elaphoglossum serpens) Terrestrial

Fern, Thelypteris inabonensis E Ferns No

(Thelypteris inabonensis) Terrestrial

Fern, Thelypteris verecunda E Ferns No

(Thelypteris verecunda) Terrestrial

Fern, Thelypteris yaucoensis E Ferns No

(Thelypteris yaucoensis) Terrestrial

Polystichum calderonense (ncn) E Ferns No

(Polystichum calderonense) Terrestrial

Tectaria Estremerana E Ferns No

(Tectaria estremerana) Terrestrial

Tree Fern, Elfin E Ferns No

(Cyathea dryopteroides) Terrestrial
Page 84 of 216 

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Aristida chaseae (ncn) E Monocot No

(Aristida chaseae) Terrestrial

Cranichis Ricartii E Monocot No

(Cranichis ricartii) Terrestrial

Lepanthes eltorensis (ncn) E Monocot No

(Lepanthes eltoroensis) Terrestrial

Manaca, palma de T Monocot No

(Calyptronoma rivalis) Terrestrial

Pelos del Diablo E Monocot No

(Aristida portoricensis) Terrestrial

Boa, Mona T Reptile Yes

(Epicrates monensis monensis) Terrestrial

Boa, Puerto Rican E Reptile No

(Epicrates inornatus) Terrestrial

Gecko, Monito E Reptile Yes

(Sphaerodactylus micropithecus) Terrestrial

Iguana, Mona Ground T Reptile Yes

(Cyclura cornuta stejnegeri) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Rhode Island ( 13) species: Taxa Critical Habitat

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Gerardia, Sandplain E Dicot No

(Agalinis acuta) Terrestrial

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No
Page 85 of 216 

(Caretta caretta) Saltwater, Coastal

South Carolina ( 39) species: Taxa Critical Habitat

Salamander, Flatwoods T Amphibian No

(Ambystoma cingulatum) Terrestrial, Freshwater, Vernal pool

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Warbler, Bachman's E Bird No

(Vermivora bachmanii) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Mussel, Heelsplitter Carolina E Bivalve Yes

(Lasmigona decorata) Freshwater

Amaranth, Seabeach T Dicot No

(Amaranthus pumilus) Coastal

Amphianthus, Little T Dicot No

(Amphianthus pusillus) Freshwater

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Coneflower, Smooth E Dicot No

(Echinacea laevigata) Terrestrial

Dropwort, Canby's E Dicot No

(Oxypolis canbyi) Terrestrial, Freshwater

Gooseberry, Miccosukee T Dicot No

(Ribes echinellum) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Heartleaf, Dwarf-flowered T Dicot No

(Hexastylis naniflora) Terrestrial

Loosestrife, Rough-leaved E Dicot No

(Lysimachia asperulaefolia) Terrestrial

Pitcher-plant, Mountain Sweet E Dicot No

(Sarracenia rubra ssp. jonesii) Terrestrial, Freshwater

Pondberry E Dicot No

(Lindera melissifolia) Terrestrial

Sunflower, Schweinitz's E Dicot No

(Helianthus schweinitzii) Terrestrial

Quillwort, Black-spored E Ferns No

(Isoetes melanospora) Vernal pool

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Lichen, Rock Gnome E Lichen No

(Gymnoderma lineare) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Wolf, Red E Mammal No

(Canis rufus) Terrestrial

Manatee, West Indian E Marine mml Yes

(Trichechus manatus) Saltwater

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater
Page 86 of 216 

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Arrowhead, Bunched E Monocot No

(Sagittaria fasciculata) Freshwater

Irisette, White E Monocot No

(Sisyrinchium dichotomum) Terrestrial

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Trillium, Persistent E Monocot No

(Trillium persistens) Terrestrial

Trillium, Relict E Monocot No

(Trillium reliquum) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Snake, Eastern Indigo T Reptile Yes

(Drymarchon corais couperi) Terrestrial

South Dakota ( 8) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Shiner, Topeka E Fish Yes

(Notropis topeka (=tristis)) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Orchid, Western Prairie Fringed T Monocot No

(Platanthera praeclara) Terrestrial

Tennessee ( 86) species: Taxa Critical Habitat

Spider, Spruce-fir Moss E Arachnid Yes

(Microhexura montivaga) Terrestrial

Stork, Wood E Bird No

(Mycteria americana) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial
Page 87 of 216 

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Combshell, Upland E Bivalve Yes

(Epioblasma metastriata) Freshwater

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Kidneyshell, Triangular E Bivalve Yes

(Ptychobranchus greenii) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Alabama Moccasinshell T Bivalve Yes

(Medionidus acutissimus) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Mussel, Coosa Moccasinshell E Bivalve Yes

(Medionidus parvulus) Freshwater

Mussel, Cumberland Combshell E Bivalve Yes

(Epioblasma brevidens) Freshwater

Mussel, Cumberland Elktoe E Bivalve Yes

(Alasmidonta atropurpurea) Freshwater

Mussel, Cumberland Pigtoe E Bivalve No

(Pleurobema gibberum) Freshwater

Mussel, Fine-lined Pocketbook T Bivalve Yes

(Lampsilis altilis) Freshwater

Mussel, Fine-rayed Pigtoe E Bivalve No

(Fusconaia cuneolus) Freshwater

Mussel, Ovate Clubshell E Bivalve Yes

(Pleurobema perovatum) Freshwater

Mussel, Oyster E Bivalve Yes

(Epioblasma capsaeformis) Freshwater

Mussel, Ring Pink (=Golf Stick Pearly) E Bivalve No

(Obovaria retusa) Freshwater

Mussel, Rough Pigtoe E Bivalve No

(Pleurobema plenum) Freshwater

Mussel, Shiny Pigtoe E Bivalve No

(Fusconaia cor) Freshwater

Mussel, Southern Pigtoe E Bivalve Yes

(Pleurobema georgianum) Freshwater

Pearlymussel, Alabama Lamp E Bivalve No

(Lampsilis virescens) Freshwater

Pearlymussel, Appalachian Monkeyface E Bivalve No

(Quadrula sparsa) Freshwater

Pearlymussel, Birdwing E Bivalve No

(Conradilla caelata) Freshwater

Pearlymussel, Cracking E Bivalve No

(Hemistena lata) Freshwater

Pearlymussel, Cumberland Bean E Bivalve No

(Villosa trabalis) Freshwater

Pearlymussel, Cumberland Monkeyface E Bivalve No

(Quadrula intermedia) Freshwater

Pearlymussel, Dromedary E Bivalve No

(Dromus dromas) Freshwater
Page 88 of 216 

Pearlymussel, Green-blossom E Bivalve No

(Epioblasma torulosa gubernaculum) Freshwater

Pearlymussel, Little-wing E Bivalve No

(Pegias fabula) Freshwater

Pearlymussel, Orange-footed E Bivalve No

(Plethobasus cooperianus) Freshwater

Pearlymussel, Pale Lilliput E Bivalve No

(Toxolasma cylindrellus) Freshwater

Pearlymussel, Purple Cat's Paw E Bivalve No

(Epioblasma obliquata obliquata) Freshwater

Pearlymussel, Tubercled-blossom E Bivalve No

(Epioblasma torulosa torulosa) Freshwater

Pearlymussel, Turgid-blossom E Bivalve No

(Epioblasma turgidula) Freshwater

Pearlymussel, White Wartyback E Bivalve No

(Plethobasus cicatricosus) Freshwater

Pearlymussel, Yellow-blossom E Bivalve No

(Epioblasma florentina florentina) Freshwater

Purple Bean E Bivalve Yes

(Villosa perpurpurea) Freshwater

Rabbitsfoot, Rough E Bivalve Yes

(Quadrula cylindrica strigillata) Freshwater

Riffleshell, Tan E Bivalve No

(Epioblasma florentina walkeri (=E. walkeri)) Freshwater

Crayfish, Nashville E Crustacean No

(Orconectes shoupi) Freshwater

Aster, Ruth's Golden E Dicot No

(Pityopsis ruthii) Terrestrial

Avens, Spreading E Dicot No

(Geum radiatum) Terrestrial

Bladderpod, Spring Creek E Dicot No

(Lesquerella perforata) Floodplain

Bluet, Roan Mountain E Dicot No

(Hedyotis purpurea var. montana) Terrestrial

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Clover, Leafy Prairie E Dicot No

(Dalea foliosa) Terrestrial

Coneflower, Tennessee Purple E Dicot No

(Echinacea tennesseensis) Terrestrial

Goldenrod, Blue Ridge T Dicot No

(Solidago spithamaea) Terrestrial

Ground-plum, Guthrie's E Dicot No

(Astragalus bibullatus) Terrestrial

Pitcher-plant, Green E Dicot No

(Sarracenia oreophila) Terrestrial, Freshwater

Potato-bean, Price's T Dicot No

(Apios priceana) Terrestrial

Rock-cress, Braun's E Dicot Yes

(Arabis perstellata E. L. Braun var. ampla Rollins) Terrestrial

Rock-cress, Small E Dicot Yes

(Arabis perstellata E. L. Braun var. perstellata Fernald) Terrestrial
Page 89 of 216 

Rosemary, Cumberland T Dicot No

(Conradina verticillata) Terrestrial

Sandwort, Cumberland E Dicot No

(Arenaria cumberlandensis) Terrestrial

Skullcap, Large-flowered T Dicot No

(Scutellaria montana) Terrestrial

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Fern, American hart's-tongue T Ferns No

(Asplenium scolopendrium var. americanum) Terrestrial

Chub, Slender T Fish Yes

(Erimystax cahni) Freshwater

Chub, Spotfin T Fish Yes

(Erimonax monachus) Freshwater

Dace, Blackside T Fish No

(Phoxinus cumberlandensis) Freshwater

Darter, Amber E Fish Yes

(Percina antesella) Freshwater

Darter, Bluemask (=jewel) E Fish No

(Etheostoma sp.) Freshwater

Darter, Boulder E Fish No

(Etheostoma wapiti) Freshwater

Darter, Duskytail E Fish No

(Etheostoma percnurum) Freshwater

Darter, Slackwater T Fish Yes

(Etheostoma boschungi) Freshwater

Darter, Snail T Fish No

(Percina tanasi) Freshwater

Logperch, Conasauga E Fish Yes

(Percina jenkinsi) Freshwater

Madtom, Pygmy E Fish No

(Noturus stanauli) Freshwater

Madtom, Smoky E Fish Yes

(Noturus baileyi) Freshwater

Madtom, Yellowfin T Fish Yes

(Noturus flavipinnis) Freshwater

Shiner, Blue T Fish No

(Cyprinella caerulea) Freshwater

Shiner, Palezone E Fish No

(Notropis albizonatus) Freshwater

Sturgeon, Pallid E Fish No

(Scaphirhynchus albus) Freshwater

Marstonia, Royal (=Royal Snail) E Gastropod No

(Pyrgulopsis ogmorhaphe) Terrestrial

Riversnail, Anthony's E Gastropod No

(Athearnia anthonyi) Freshwater

Snail, Painted Snake Coiled Forest T Gastropod No

(Anguispira picta) Terrestrial

Lichen, Rock Gnome E Lichen No

(Gymnoderma lineare) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous
Page 90 of 216 

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Squirrel, Carolina Northern Flying E Mammal No

(Glaucomys sabrinus coloratus) Terrestrial

Wolf, Red E Mammal No

(Canis rufus) Terrestrial

Grass, Tennessee Yellow-eyed E Monocot No

(Xyris tennesseensis) Terrestrial

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Texas ( 89) species: Taxa Critical Habitat

Salamander, Barton Springs E Amphibian No

(Eurycea sosorum) Terrestrial, Freshwater

Salamander, San Marcos T Amphibian Yes

(Eurycea nana) Terrestrial, Freshwater

Salamander, Texas Blind E Amphibian No

(Typhlomolge rathbuni) Freshwater, Subterraneous

Toad, Houston E Amphibian Yes

(Bufo houstonensis) Terrestrial, Freshwater

Harvestman, Bee Creek Cave E Arachnid No

(Texella reddelli) Terrestrial, Subterraneous

Harvestman, Bone Cave E Arachnid No

(Texella reyesi) Terrestrial, Subterraneous

Harvestman, Robber Baron Cave E Arachnid Yes

(Texella cokendolpheri) Terrestrial, Subterraneous

Meshweaver, Braken Bat Cave E Arachnid Yes

(Cicurina venii) Terrestrial, Subterraneous

Pseudoscorpion, Tooth Cave E Arachnid No

(Tartarocreagris texana) Terrestrial, Subterraneous

Spider, Government Canyon Cave E Arachnid No

(Neoleptoneta microps) Terrestrial, Subterraneous

Spider, Madla's Cave E Arachnid Yes

(Cicurina madla) Terrestrial, Subterraneous

Spider, Robber Baron Cave E Arachnid Yes

(Cicurina baronia) Terrestrial, Subterraneous

Spider, Tooth Cave E Arachnid No

(Leptoneta myopica) Terrestrial, Subterraneous

Spider, Vesper Cave E Arachnid Yes

(Cicurina vespera) Terrestrial, Subterraneous

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Curlew, Eskimo E Bird No

(Numenius borealis) Terrestrial

Falcon, Northern Aplomado E Bird No

(Falco femoralis septentrionalis) Terrestrial

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Owl, Mexican Spotted T Bird Yes

(Strix occidentalis lucida) Terrestrial

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Plover, Piping E Bird Yes
Page 91 of 216 

(Charadrius melodus) Terrestrial

Prairie-chicken, Attwater's Greater E Bird No

(Tympanuchus cupido attwateri) Terrestrial

Tern, Interior (population) Least E Bird No

(Sterna antillarum) Terrestrial

Vireo, Black-capped E Bird No

(Vireo atricapilla) Terrestrial

Warbler (=Wood), Golden-cheeked E Bird No

(Dendroica chrysoparia) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Amphipod, Peck's Cave E Crustacean No

(Stygobromus (=Stygonectes) pecki) Freshwater, Subterraneous

Ambrosia, South Texas E Dicot No

(Ambrosia cheiranthifolia) Terrestrial

Ayenia, Texas E Dicot No

(Ayenia limitaris) Terrestrial

Bladderpod, White E Dicot No

(Lesquerella pallida) Terrestrial

Bladderpod, Zapata E Dicot Yes

(Lesquerella thamnophila) Terrestrial

Cactus, Black Lace E Dicot No

(Echinocereus reichenbachii var. albertii) Terrestrial

Cactus, Bunched Cory T Dicot No

(Coryphantha ramillosa) Terrestrial

Cactus, Chisos Mountain Hedgehog T Dicot No

(Echinocereus chisoensis var. chisoensis) Terrestrial

Cactus, Lloyd's Mariposa T Dicot No

(Echinomastus mariposensis) Terrestrial

Cactus, Nellie Cory E Dicot No

(Coryphantha minima) Terrestrial

Cactus, Sneed Pincushion E Dicot No

(Coryphantha sneedii var. sneedii) Terrestrial

Cactus, Star E Dicot No

(Astrophytum asterias) Terrestrial

Cactus, Tobusch Fishhook E Dicot No

(Ancistrocactus tobuschii) Terrestrial

Cat's-eye, Terlingua Creek E Dicot No

(Cryptantha crassipes) Terrestrial

Dawn-flower, Texas Prairie (=Texas Bitterweed) E Dicot No

(Hymenoxys texana) Terrestrial

Dogweed, Ashy E Dicot No

(Thymophylla tephroleuca) Terrestrial

Frankenia, Johnston's E Dicot No

(Frankenia johnstonii) Terrestrial

Fruit, Earth (=geocarpon) T Dicot No

(Geocarpon minimum) Terrestrial

Manioc, Walker's E Dicot No

(Manihot walkerae) Terrestrial

Oak, Hinckley T Dicot No

(Quercus hinckleyi) Terrestrial

Phlox, Texas Trailing E Dicot No
Page 92 of 216 

(Phlox nivalis ssp. texensis) Terrestrial

Pitaya, Davis' Green E Dicot No

(Echinocereus viridiflorus var. davisii) Terrestrial

Poppy-mallow, Texas E Dicot No

(Callirhoe scabriuscula) Terrestrial

Rush-pea, Slender E Dicot No

(Hoffmannseggia tenella) Terrestrial

Sand-verbena, Large-fruited E Dicot No

(Abronia macrocarpa) Terrestrial

Snowbells, Texas E Dicot No

(Styrax texanus) Terrestrial

Sunflower, Pecos T Dicot Yes

(Helianthus paradoxus) Terrestrial, Perm. wetland

Wild-buckwheat, Gypsum T Dicot Yes

(Eriogonum gypsophilum) Terrestrial

Darter, Fountain E Fish Yes

(Etheostoma fonticola) Freshwater

Gambusia, Big Bend E Fish No

(Gambusia gaigei) Freshwater

Gambusia, Clear Creek E Fish No

(Gambusia heterochir) Freshwater

Gambusia, Pecos E Fish No

(Gambusia nobilis) Freshwater

Gambusia, San Marcos E Fish Yes

(Gambusia georgei) Freshwater

Minnow, Devils River T Fish No

(Dionda diaboli) Freshwater

Pupfish, Comanche Springs E Fish No

(Cyprinodon elegans) Freshwater

Pupfish, Leon Springs E Fish Yes

(Cyprinodon bovinus) Freshwater

Shiner, Arkansas River T Fish Yes

(Notropis girardi) Freshwater

Snail, Pecos Assiminea E Gastropod Yes

(Assiminea pecos) Freshwater

Beetle, American Burying E Insect No

(Nicrophorus americanus) Terrestrial

Beetle, Coffin Cave Mold E Insect No

(Batrisodes texanus) Subterraneous

Beetle, Comal Springs Dryopid E Insect No

(Stygoparnus comalensis) Freshwater, Subterraneous

Beetle, Comal Springs Riffle E Insect No

(Heterelmis comalensis) Freshwater, Subterraneous

Beetle, Helotes Mold E Insect Yes

(Batrisodes venyivi) Subterraneous

Beetle, Kretschmarr Cave Mold E Insect No

(Texamaurops reddelli) Subterraneous

Beetle, Tooth Cave Ground E Insect No

(Rhadine persephone) Subterraneous

Rhadine exilis (ncn) E Insect Yes

(Rhadine exilis) Terrestrial, Subterraneous

Rhadine infernalis (ncn) E Insect Yes
Page 93 of 216 

(Rhadine infernalis) Terrestrial, Subterraneous

Bat, Mexican Long-nosed E Mammal No

(Leptonycteris nivalis) Terrestrial, Subterraneous

Bear, Louisiana Black T Mammal No

(Ursus americanus luteolus) Terrestrial

Jaguar E Mammal No

(Panthera onca) Terrestrial

Jaguarundi, Gulf Coast E Mammal No

(Herpailurus (=Felis) yagouaroundi cacomitli) Terrestrial

Jaguarundi, Sinaloan E Mammal No

(Herpailurus (=Felis) yagouaroundi tolteca) Terrestrial

Ocelot E Mammal No

(Leopardus (=Felis) pardalis) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Ladies'-tresses, Navasota E Monocot No

(Spiranthes parksii) Terrestrial

Wild-rice, Texas E Monocot Yes

(Zizania texana) Freshwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Snake, Concho Water T Reptile Yes

(Nerodia paucimaculata) Terrestrial, Freshwater

Utah ( 33) species: Taxa Critical Habitat

Flycatcher, Southwestern Willow E Bird Yes

(Empidonax traillii extimus) Terrestrial

Owl, Mexican Spotted T Bird Yes

(Strix occidentalis lucida) Terrestrial

Bearclaw poppy, Dwarf E Dicot No

(Arctomecon humilis) Terrestrial

Buttercup, Autumn E Dicot No

(Ranunculus aestivalis (=acriformis)) Terrestrial

Cactus, Siler Pincushion T Dicot No

(Pediocactus (=Echinocactus,=Utahia) sileri) Terrestrial

Cactus, Uinta Basin Hookless T Dicot No

(Sclerocactus glaucus) Terrestrial

Cactus, Winkler T Dicot No

(Pediocactus winkleri) Terrestrial

Cactus, Wright Fishhook E Dicot No

(Sclerocactus wrightiae) Terrestrial

Cycladenia, Jones T Dicot No

(Cycladenia jonesii (=humilis)) Terrestrial
Page 94 of 216 

Daisy, Maguire T Dicot No

(Erigeron maguirei) Freshwater

Milk-vetch, Deseret T Dicot No

(Astragalus desereticus) Terrestrial

Milk-vetch, Heliotrope T Dicot Yes

(Astragalus montii) Terrestrial

Milk-vetch, Holmgren E Dicot No

(Astragalus holmgreniorum) Terrestrial

Milk-vetch, Shivwits E Dicot No

(Astragalus ampullarioides) Terrestrial

Phacelia, Clay E Dicot No

(Phacelia argillacea) Terrestrial

Primrose, Maguire T Dicot No

(Primula maguirei) Terrestrial

Reed-mustard, Barneby E Dicot No

(Schoenocrambe barnebyi) Terrestrial

Reed-mustard, Shrubby E Dicot No

(Schoenocrambe suffrutescens) Terrestrial

Ridge-cress (=Pepper-cress), Barneby E Dicot No

(Lepidium barnebyanum) Terrestrial

Townsendia, Last Chance T Dicot No

(Townsendia aprica) Terrestrial

Chub, Bonytail E Fish Yes

(Gila elegans) Freshwater

Chub, Humpback E Fish Yes

(Gila cypha) Freshwater

Chub, Virgin River E Fish Yes

(Gila seminuda (=robusta)) Freshwater

Squawfish, Colorado E Fish Yes

(Ptychocheilus lucius) Freshwater

Sucker, June E Fish Yes

(Chasmistes liorus) Freshwater

Sucker, Razorback E Fish Yes

(Xyrauchen texanus) Freshwater

Trout, Lahontan Cutthroat T Fish No

(Oncorhynchus clarki henshawi) Freshwater

Woundfin E Fish Yes

(Plagopterus argentissimus) Freshwater

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Prairie Dog, Utah T Mammal No

(Cynomys parvidens) Terrestrial, Subterraneous

Ladies'-tresses, Ute T Monocot No

(Spiranthes diluvialis) Terrestrial

Sedge, Navajo T Monocot Yes

(Carex specuicola) Terrestrial

Tortoise, Desert T Reptile Yes

(Gopherus agassizii) Terrestrial

Vermont ( 4) species: Taxa Critical Habitat

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Milk-vetch, Jesup's E Dicot No
Page 95 of 216 

(Astragalus robbinsii var. jesupi) Terrestrial

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Virginia ( 65) species: Taxa Critical Habitat

Salamander, Shenandoah E Amphibian No

(Plethodon shenandoah) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Woodpecker, Red-cockaded E Bird No

(Picoides borealis) Terrestrial

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Cumberland Combshell E Bivalve Yes

(Epioblasma brevidens) Freshwater

Mussel, Cumberland Elktoe E Bivalve Yes

(Alasmidonta atropurpurea) Freshwater

Mussel, Dwarf Wedge E Bivalve No

(Alasmidonta heterodon) Freshwater

Mussel, Fine-rayed Pigtoe E Bivalve No

(Fusconaia cuneolus) Freshwater

Mussel, Oyster E Bivalve Yes

(Epioblasma capsaeformis) Freshwater

Mussel, Rough Pigtoe E Bivalve No

(Pleurobema plenum) Freshwater

Mussel, Shiny Pigtoe E Bivalve No

(Fusconaia cor) Freshwater

Pearlymussel, Appalachian Monkeyface E Bivalve No

(Quadrula sparsa) Freshwater

Pearlymussel, Birdwing E Bivalve No

(Conradilla caelata) Freshwater

Pearlymussel, Cracking E Bivalve No

(Hemistena lata) Freshwater

Pearlymussel, Cumberland Bean E Bivalve No

(Villosa trabalis) Freshwater

Pearlymussel, Cumberland Monkeyface E Bivalve No

(Quadrula intermedia) Freshwater

Pearlymussel, Dromedary E Bivalve No

(Dromus dromas) Freshwater

Pearlymussel, Green-blossom E Bivalve No

(Epioblasma torulosa gubernaculum) Freshwater

Pearlymussel, Little-wing E Bivalve No

(Pegias fabula) Freshwater

Purple Bean E Bivalve Yes

(Villosa perpurpurea) Freshwater

Rabbitsfoot, Rough E Bivalve Yes

(Quadrula cylindrica strigillata) Freshwater

Riffleshell, Tan E Bivalve No

(Epioblasma florentina walkeri (=E. walkeri)) Freshwater
Page 96 of 216 

Spinymussel, James River E Bivalve No

(Pleurobema collina) Freshwater

Isopod, Lee County Cave E Crustacean No

(Lirceus usdagalun) Freshwater

Isopod, Madison Cave T Crustacean No

(Antrolana lira) Freshwater

Amaranth, Seabeach T Dicot No

(Amaranthus pumilus) Coastal

Birch, Virginia Round-leaf T Dicot No

(Betula uber) Floodplain

Bittercress, Small-anthered E Dicot No

(Cardamine micranthera) Terrestrial

Chaffseed, American E Dicot No

(Schwalbea americana) Terrestrial

Coneflower, Smooth E Dicot No

(Echinacea laevigata) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Joint-vetch, Sensitive T Dicot No

(Aeschynomene virginica) Terrestrial, Brackish

Mallow, Peter's Mountain E Dicot No

(Iliamna corei) Terrestrial

Rock-cress, Shale Barren E Dicot No

(Arabis serotina) Terrestrial

Sneezeweed, Virginia T Dicot No

(Helenium virginicum) Vernal pool

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Sumac, Michaux's E Dicot No

(Rhus michauxii) Terrestrial

Sunflower, Schweinitz's E Dicot No

(Helianthus schweinitzii) Terrestrial

Chub, Slender T Fish Yes

(Erimystax cahni) Freshwater

Chub, Spotfin T Fish Yes

(Erimonax monachus) Freshwater

Dace, Blackside T Fish No

(Phoxinus cumberlandensis) Freshwater

Darter, Duskytail E Fish No

(Etheostoma percnurum) Freshwater

Logperch, Roanoke E Fish No

(Percina rex) Freshwater

Madtom, Yellowfin T Fish Yes

(Noturus flavipinnis) Freshwater

Sturgeon, Shortnose E Fish No

(Acipenser brevirostrum) Freshwater, Saltwater

Snail, Virginia Fringed Mountain E Gastropod No

(Polygyriscus virginianus) Terrestrial

Beetle, Northeastern Beach Tiger T Insect No

(Cicindela dorsalis dorsalis) Terrestrial

Butterfly, Mitchell's Satyr E Insect No

(Neonympha mitchellii mitchellii) Terrestrial, Perm. wetland
Page 97 of 216 

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Virginia Big-eared E Mammal Yes

(Corynorhinus (=Plecotus) townsendii virginianus) Terrestrial, Subterraneous

Squirrel, Delmarva Peninsula Fox E Mammal No

(Sciurus niger cinereus) Terrestrial

Whale, Finback E Marine mml No

(Balaenoptera physalus) Saltwater

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Atlantic right E Marine mml Yes

(Eubalaena glacialis (incl. australis)) Saltwater

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Pink, Swamp T Monocot No

(Helonias bullata) Terrestrial, Freshwater

Pogonia, Small Whorled T Monocot No

(Isotria medeoloides) Terrestrial

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, hawksbill E Reptile Yes

(Eretmochelys imbricata) Saltwater, Coastal

Sea turtle, Kemp's ridley E Reptile No

(Lepidochelys kempii) Saltwater, Coastal

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

Sea turtle, loggerhead T Reptile No

(Caretta caretta) Saltwater, Coastal

Washington ( 23) species: Taxa Critical Habitat

Murrelet, Marbled T Bird Yes

(Brachyramphus marmoratus) Terrestrial, Freshwater, Saltwater

Owl, Northern Spotted T Bird Yes

(Strix occidentalis caurina) Terrestrial

Pelican, Brown E Bird No

(Pelecanus occidentalis) Terrestrial

Plover, Western Snowy T Bird Yes

(Charadrius alexandrinus nivosus) Terrestrial

Catchfly, Spalding's T Dicot No

(Silene spaldingii) Terrestrial

Checker-mallow, Nelson's T Dicot No

(Sidalcea nelsoniana) Terrestrial

Checker-mallow, Wenatchee Mountains E Dicot Yes

(Sidalcea oregana var. calva) Terrestrial

Howellia, Water T Dicot No

(Howellia aquatilis) Freshwater

Lupine, Kincaid's T Dicot Yes

(Lupinus sulphureus (=oreganus) ssp. kincaidii (=var. kincaidii)) Terrestrial

Paintbrush, Golden T Dicot No
Page 98 of 216 

(Castilleja levisecta) Terrestrial

Stickseed, Showy E Dicot No

(Hackelia venusta) Terrestrial

Salmon, Chum T Fish Yes

(Oncorhynchus (=Salmo) keta) Freshwater, Brackish, Saltwater

Salmon, Sockeye E Fish No

(Oncorhynchus (=Salmo) nerka) Freshwater, Brackish, Saltwater

Steelhead E Fish Yes

(Oncorhynchus (=Salmo) mykiss) Freshwater, Brackish, Saltwater

Trout, Bull T Fish Yes

(Salvelinus confluentus) Freshwater

Bear, Grizzly T Mammal No

(Ursus arctos horribilis) Terrestrial

Deer, Columbian White-tailed E Mammal No

(Odocoileus virginianus leucurus) Terrestrial

Rabbit, Pygmy E Mammal No

(Brachylagus idahoensis) Terrestrial

Sea-lion, Steller (eastern) T Marine mml Yes

(Eumetopias jubatus) Saltwater, Coastal

Whale, Humpback E Marine mml No

(Megaptera novaeangliae) Saltwater

Whale, North Pacific right E Marine mml Yes

(Eubalaena japonica) Saltwater

Sea turtle, green E Reptile Yes

(Chelonia mydas) Saltwater

Sea turtle, leatherback E Reptile Yes

(Dermochelys coriacea) Saltwater, Coastal

West Virginia ( 16) species: Taxa Critical Habitat

Salamander, Cheat Mountain T Amphibian No

(Plethodon nettingi) Terrestrial, Freshwater

Fanshell E Bivalve No

(Cyprogenia stegaria) Freshwater

Mucket, Pink (Pearlymussel) E Bivalve No

(Lampsilis abrupta) Freshwater

Mussel, Clubshell E Bivalve No

(Pleurobema clava) Freshwater

Pearlymussel, Tubercled-blossom E Bivalve No

(Epioblasma torulosa torulosa) Freshwater

Spinymussel, James River E Bivalve No

(Pleurobema collina) Freshwater

Clover, Running Buffalo E Dicot No

(Trifolium stoloniferum) Terrestrial

Harperella E Dicot No

(Ptilimnium nodosum) Freshwater

Rock-cress, Shale Barren E Dicot No

(Arabis serotina) Terrestrial

Spiraea, Virginia T Dicot No

(Spiraea virginiana) Terrestrial

Snail, Flat-spired Three-toothed T Gastropod No

(Triodopsis platysayoides) Terrestrial

Bat, Gray E Mammal No

(Myotis grisescens) Terrestrial, Subterraneous
Page 99 of 216 

Bat, Indiana E Mammal Yes

(Myotis sodalis) Terrestrial, Subterraneous

Bat, Virginia Big-eared E Mammal Yes

(Corynorhinus (=Plecotus) townsendii virginianus) Terrestrial, Subterraneous

Squirrel, Carolina Northern Flying E Mammal No

(Glaucomys sabrinus coloratus) Terrestrial

Bulrush, Northeastern (=Barbed Bristle) E Monocot No

(Scirpus ancistrochaetus) Terrestrial, Freshwater

Wisconsin ( 14) species: Taxa Critical Habitat

Crane, Whooping E Bird Yes

(Grus americana) Terrestrial, Freshwater

Plover, Piping E Bird Yes

(Charadrius melodus) Terrestrial

Warbler (=Wood), Kirtland's E Bird No

(Dendroica kirtlandii) Terrestrial

Mussel, Winged Mapleleaf E Bivalve No

(Quadrula fragosa) Freshwater

Pearlymussel, Higgins' Eye E Bivalve No

(Lampsilis higginsii) Freshwater

Clover, Prairie Bush T Dicot No

(Lespedeza leptostachya) Terrestrial

Locoweed, Fassett's T Dicot No

(Oxytropis campestris var. chartacea) Terrestrial

Monkshood, Northern Wild T Dicot No

(Aconitum noveboracense) Terrestrial

Thistle, Pitcher's T Dicot No

(Cirsium pitcheri) Terrestrial

Butterfly, Karner Blue E Insect No

(Lycaeides melissa samuelis) Terrestrial

Dragonfly, Hine's Emerald E Insect Yes

(Somatochlora hineana) Terrestrial, Freshwater

Lynx, Canada T Mammal No

(Lynx canadensis) Terrestrial

Iris, Dwarf Lake T Monocot No

(Iris lacustris) Terrestrial

Orchid, Eastern Prairie Fringed T Monocot No

(Platanthera leucophaea) Terrestrial

Wyoming ( 5) species: Taxa Critical Habitat

Butterfly Plant, Colorado T Dicot Yes

(Gaura neomexicana var. coloradensis) Terrestrial

Yellowhead, Desert T Dicot Yes

(Yermo xanthocephalus) Terrestrial

Bear, Grizzly T Mammal No

(Ursus arctos horribilis) Terrestrial

Ferret, Black-footed E Mammal No

(Mustela nigripes) Terrestrial

Mouse, Preble's Meadow Jumping T Mammal Yes

(Zapus hudsonius preblei) Terrestrial

No species were selected for exclusion.

Dispersed species included in report. 
Page 100 of 216 

10/28/2009 11:34:39 AM Ver. 2.10.4

 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, 

PESTICIDES AND TOXIC SUBSTANCES

Environmental Fate and Ecological Risk Assessment 

New Chemical Registration (Section 3) 

Spirotetramat 

CAS No. 203313-25-5 

PC Code 392201 
Page 101 of 216 

N

H

O

O

O

O

CH3

H3C H3C

O

H3C

Prepared by: 

Michael Hoffmann, Biologist 

José L. Meléndez, Chemist 

United States Environmental Protection Agency 

Office of Pesticide Programs 

Environmental Fate and Effects Division 

Environmental Risk Branch V 

Ariel Rios Building 

1200 Pennsylvania Ave., NW 

Mail Code 7507P 

Washington, DC 20460 

Reviewed by: 

Nicholas E. Federoff, Wildlife Biologist

Michael Barrett, Ph.D., Chemist 

Mah T. Shamim, Ph.D., Branch Chief 

Environmental Risk Branch V 

Date: May 13, 2008 

TABLE OF CONTENTS 

I. Executive Summary .................................................................................................................... 103

A. Nature of Chemical Stressor .................................................................................................. 103

B. Assessment of Potential Risks to Non-Listed Non-Target Organisms ............................... 104

C. Assessment of Potential Risks to Federally Listed Species ................................................. 105

D. Exposure Characterization .................................................................................................... 106

E. Effects Characterization ......................................................................................................... 108

F. Uncertainties and Data Gaps ................................................................................................ 109

1. Environmental Fate ............................................................................................................... 109

2. Ecological Effects ................................................................................................................... 110

II. Problem Formulation ................................................................................................................. 112

A. Nature of Regulatory Action ..................................................................................................... 112

B. Stressor Source and Distribution ............................................................................................. 112

1. Nature of the Chemical Stressor ........................................................................................ 112

2. Overview of Pesticide Usage ................................................................................................. 114

C. Receptors ................................................................................................................................ 114

1. Aquatic and Terrestrial Effects ............................................................................................ 114

a. Degradates ......................................................................................................................... 115

b. Formulations ...................................................................................................................... 116

c. Chronic ............................................................................................................................... 116
Page 102 of 216 

2. Ecosystems Potentially at Risk .......................................................................................... 117

D. Assessment Endpoints ............................................................................................................... 117

E. Conceptual Model ................................................................................................................... 117

1. Risk Hypothesis .................................................................................................................. 118

2. Conceptual Diagram .......................................................................................................... 118

F. Analysis Plan ............................................................................................................................ 119

1. Preliminary Identification of Data Gaps and Analysis Plan .......................................... 120

2. Measures of Exposure and Effects .................................................................................... 120

III. Analysis ....................................................................................................................................... 122

A. Use Characterization ................................................................................................................. 122

B. Exposure Characterization ....................................................................................................... 126

1. Environmental Fate and Transport Characterization ....................................................... 126

a. Summary of Empirical Data ............................................................................................ 128

b. General ............................................................................................................................... 129

c. Degradation ....................................................................................................................... 129

d. Metabolism and Transformation Products ..................................................................... 130

e. Soil Sorption, Mobility and Transport ............................................................................ 132

f. Field Dissipation ................................................................................................................ 132

g. Bioaccumulation ................................................................................................................ 133

h. Uncertainties and Issues ................................................................................................... 135

2. Measures of Aquatic Exposure ............................................................................................. 136

a. Aquatic Exposure Modeling ............................................................................................. 136

b. Aquatic Exposure Monitoring (Field Data) .................................................................... 144

3. Measures of Terrestrial Exposure ........................................................................................ 144

a. Exposure Modeling: Non-Target Mammals and Birds ................................................ 144

b. Exposure Modeling: Non-target Invertebrates ............................................................. 147

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

(Wetland) Areas ......................................................................................................................... 147

C. Ecological Effects Characterization ......................................................................................... 148

1. Toxicity Data Summary ........................................................................................................ 149

2. Aquatic Toxicity .................................................................................................................... 152

a. Acute Effects ...................................................................................................................... 152

b. Chronic/Reproductive Effects .......................................................................................... 153

3. Terrestrial Toxicity................................................................................................................ 153

a. Terrestrial Vertebrates ..................................................................................................... 153

i. Acute Effects .................................................................................................................. 153

ii. Chronic/Reproductive Effects ...................................................................................... 154

b. Terrestrial Invertebrates .................................................................................................. 155

c. Terrestrial Plants .............................................................................................................. 157

IV. Risk Characterization ................................................................................................................ 159

A. Risk Estimation - Integration of Exposure and Effects Data ................................................. 159

1. Risks to Non-Target Aquatic Organisms ............................................................................ 159

2. Risks to Non-Target Terrestrial Organisms ....................................................................... 161

a. Risks to Non-Target Birds ................................................................................................ 161

b. Risks to Non-Target Mammals ........................................................................................ 163

c. Risks to Non-Target Terrestrial Invertebrates ............................................................... 164

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

Areas ........................................................................................................................................... 164

B. Risk Description ......................................................................................................................... 165

1. Risks to Non-Target Aquatic Organisms ............................................................................ 167
Page 103 of 216 

2. Risks to Non-Target Terrestrial Organisms ....................................................................... 169

a. Non-Target Birds and Mammals ..................................................................................... 169

c. Non-Target Terrestrial Invertebrates ............................................................................. 175

d. Non-Target Plants Inhabiting Dry (Upland) and Semi-Aquatic (Wetland) Areas ..... 177

4. Endocrine Effects ................................................................................................................... 178

V. Federally Listed Threatened and Endangered Species Concerns ............................................. 179

A. Action Area ................................................................................................................................. 179

B. Taxonomic Groups Potentially at Risk .................................................................................... 179

1. Discussion of Risk Quotients ................................................................................................ 179

2. Probit Dose Response Relationship ...................................................................................... 181

C. Indirect Effects Analysis ............................................................................................................ 184

D. Critical Habitat .......................................................................................................................... 184

E. Co-occurrence Analysis ............................................................................................................. 185

VI. Literature Cited ......................................................................................................................... 185

List of Appendices

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 

I. Executive Summary

A. Nature of Chemical Stressor 

Spirotetramat (CAS No. 203313-25-5; CAS Name cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-

azaspiro[4.5]dec-3-en-4-yl ethyl carbonate; IUPAC Name cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-

xylyl)-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 and/or 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 fruit climbing, pome fruits, stone fruits, 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. 
Page 104 of 216 

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-enol is further oxidized at the benzylic carbon to yield 

spirotetramat-ketohydroxy, another major metabolite. For the structure of spirotetramat, and its major 

metabolites, please, refer to Tables III.2 and III.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 I.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. 

Table I.1. Summary of Environmental Risk Conclusions for Non-Listed Taxa Exposed to Spirotetramat 

Assessment Endpoint Identified 

Concerns 

Summarized Risk Characterization and Major Uncertainties 

Acute and Chronic Risk 

to All Freshwater and 

Estuarine/marine Plants 

and Animals 

None The best available information and the results of the most conservative 

scenario considered demonstrated that all acute and chronic risk 

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 estuarine/marine 

organisms, acute toxicity estimates appear to be roughly equivalent in 

sensitivity to those for freshwater organisms, and the low chronic risk 

to freshwater fish and invertebrates is presumed to apply also to 

estuarine/marine organisms. 

Acute and Chronic Risk 

to Birds 

Chronic No acute RQs exceeded the Agency’s acute LOCs for birds under the 

upper-bound exposure scenario considered. 

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

NOAECof <28.8 mg/kg-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 

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 
Page 105 of 216 

both the parent-only (RQ range = >0.82 to >1.50) and total residues 

approaches (RQ range = >0.93 to >1.82). In addition, the RQ for birds 

feeding on broadleaf plants/small insects under the pome fruit scenario 

when using the total residue approach also currently exceeds the 

chronic risk LOC (RQ = >1.02). 

Acute and Chronic Risks 

to Mammals 

None 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. 

Risks to Upland and 

Wetland Plants 

None 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. 

Risks to Terrestrial NonTarget Insects 

Acute and 

Chronic 

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 

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. 

Risks to Earthworms None 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 spirotetramat 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. 

C. Assessment of Potential Risks to Federally Listed Species 

Table I.2 summarizes the conclusions of potential concerns for direct and indirect effects to federallylisted threatened and endangered species (listed species). Additional discussion is included in Section V 

(“Federally Listed Threatened and Endangered Species Concerns”) of this assessment. 
Page 106 of 216 

Table I.2. Potential Direct and Indirect Effects to Listed Species 

Listed 

Taxonomic 

Group 

Is there 

Potential for 

Direct 

Effects? 

Basis for Direct 

Effects Potential 

Is there Potential 

for Indirect Effects 

Based on Direct 

Effects LOCs?

Taxonomic Groups Potentially 

Directly Affected that Could 

Result in Indirect Effects 

Terrestrial and 

semi-aquatic plants 

– monocots and 

dicots 

No No LOCs were 

exceeded Yes Terrestrial invertebrates, birds 

Terrestrial 

invertebrates Yes 

Toxic effects 

observed in 

available studies at 

less than the 

proposed maximum 

application rate 

Yes Birds, terrestrial amphibians, and 

reptiles 

Birds, terrestrial 

amphibians, and 

reptiles1

Yes Chronic LOCs were 

exceeded Yes Terrestrial invertebrates 

Mammals No No LOCs were 

exceeded Yes Terrestrial invertebrates 

 Aquatic plants 

(vascular and nonvascular) No No LOCs were 

exceeded Yes Terrestrial invertebrates 

Fish, aquatic 

amphibians2 No No LOCs were 

exceeded Yes Terrestrial invertebrates, birds, 

terrestrial amphibians, and reptiles 

Aquatic 

Invertebrates No No LOCs were 

exceeded Yes Birds, terrestrial amphibians, and reptiles 1 Birds are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, 

reptilian, and amphibian species are considered equivalent. 

2 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.

D. Exposure Characterization 

Spirotetramat may degrade/ 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 DT50’s range <<1-2.8 days). Hydrolysis in neutral and 

acidic environments (DT50’s 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-enol (assumed to be quantitative); 

subsequently, spirotetramat-enol is oxidized at the benzylic carbon position into spirotetramatketohydroxy. Spirotetramat-enol 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 III.2 and III.4, respectively. Also, refer to 

Fig. III-1, for the proposed metabolic pathway of spirotetramat.) 

Spirotetramat-enol is also generally short lived in aerobic soil environments (DT50 <1 day), but could be 

more persistent to hydrolysis or in aquatic or anaerobic media (stable to hydrolysis; DT50 = 37.9-59.0 

days to aerobic aquatic metabolism; stable to anaerobic soil and aquatic metabolism). Spirotetramat-
Page 107 of 216 

ketohydroxy showed DT50’s 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 (DT50’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-enol 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 (t1⁄2’s) of 161-204 days were estimated from the 

aerobic soil metabolism studies for spirotetramat-enol + spirotetramat-ketohydroxy + non-extracted 

residues; while half-lives of 141-693 days were estimated from the aerobic aquatic metabolism studies for 

spirotetramat + spirotetramat-enol + 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 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 (11.3-17.5% 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 (11.5-42.9% 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 (10% AR) and dimethylbenzoic acid (21.8% of AR) were observed in the 
Page 108 of 216 

samples. Methoxy-cyclohexanone and dimethylbenzoic acid were observed only in the irradiated 

samples. 

For spirotetramat (mean Kd = 4.39 mL/g; mean KOC = 289 mL/gOC), spirotetramat-enol (mean KOC = 55 

mL/gOC) and spirotetramat-ketohydroxy’s (mean Kd = 1.067 mL/g; mean KOC = 65.3 mL/gOC), mobility 

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

FAO mobility classification). Given the low vapor pressure of spirotetramat (4.2x10-11 mmHg) and its 

low Henry’s Law Constant (6.90x10-13 Atm-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 

CaCl2), conducted in NY, FL, CA and WA, also confirm the laboratory findings of rapid degradation/ 

dissipation of spirotetramat (DT50’s 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-enol and spirotetramat-ketohydroxy. They were 

not present at significant amounts below the 0-15-cm soil layer. Half-dissipation times for the combined 

residues of spirotetramat-enol and spirotetramat-ketohydroxy ranged from 4.6-31.6 days, in the 0-45 cm 

soil depth. Spirotetramat-MA-amide was also monitored in the field, with very limited detections. 

Spirotetramat, spirotetramat-enol and spirotetramat-ketohydroxy are not likely to bioaccumulate/ 

bioconcentrate because their KOW’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 

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-enol 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 
Page 109 of 216 

monocots (corn, oats, ryegrass, and shattercane) in the available vegetative vigor studies, including: 

reduced shoot dry weight, reduced length, and fresh weight. The only dicot affected was canola (reduced 

fresh weight). 

Spirotetramat can be classified as moderately toxic to freshwater and estuarine/marine fish, slightly to 

highly toxic to freshwater invertebrates, and moderately to highly toxic to estuarine/marine invertebrates 

on an acute basis. Although there is no toxicity classification scheme for aquatic vascular and nonvascular 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 and/or reproductive effects resulting from spirotetramat use as 

demonstrated in studies with birds (e.g., ↓mean hatchling bodyweight, ↓ # of 14-day survivors, ↓ # of 

viable 14-day embryos, ↓# of live embryos, and ↓# of eggs hatched), mammals (e.g., ↓ body weight and 

body weight gain in parental and offspring generations, ↑abnormal sperm cells and ↓ reproductive 

performance in parental males), fish (e.g., ↓fry survival), midges (↓emergence and developmental rate), 

and water fleas (↓reproduction, ↓parental growth, and ↑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. 

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-enol and 

spirotetramat-ketohydroxy). 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 degradation/ 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-enol dimers 1 and 2, at up to 5.0 and 7.0% of AR, respectively in the soil metabolism 

studies, were ≤1.5% 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 
Page 110 of 216 

an increased formation of the dimers. For the tests conducted with spirotetramat-enol (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 DT50’s for spirotetramat-enol 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-enol 

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 

CaCl2 solution); all the derived Kd’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. 

The available KOC’s for spirotetramat-enol were estimated from 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-enol 

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-enol 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 applications/ 

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, and/or 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 
Page 111 of 216 

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 Reproduction Study with the Mallard Duck (Anas platyrhynchos):

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 mg/kg-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 mg/kg-diet included 

reductions in # of 14-day survivors (↓22%), # of viable 14-day embryos (↓18%), # of live embryos 

(↓18%), and # of eggs hatched (↓22%). 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.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 promelas): 

Under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registration of conventional 
Page 112 of 216 

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 96–hour LC50

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 Study 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; Aquatic invertebrate life-cycle (Estuarine/Marine):

Chronic toxicity data for estuarine/marine 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 EC50 is <1mg/L and the highest estimated environmental concentration 

(EEC) in water is ≥ 0.01 of the acute EC50. However, these toxicity estimates are based on toxicity to the 

eastern oyster, yet the chronic life-cycle study with estuarine/marine 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 estuarine/marine 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 Spirotetramat. 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 (FIFRA), 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 113 of 216 

Table II.1. Nature of the Chemical Stressor

Common name Spirotetramat 

Chemical name Carbonic acid, cis-3-(2,5-dimethylphenyl)-8-methoxy-2- oxo-1-azaspiro[4.5]dec-3-en-4-yl ethyl ester 

Pesticide type Insecticide 

Chemical class Tetramic acid derivative (ketoenole) 

Mode of action Lipid biosynthesis inhibithor (LBI), classified as Group 23 Insecticide 

CAS number 203313-25-1 

Empirical formula C21H27NO5

Molecular mass 373.45 

Vapor pressure 5.6x10-9 Pa = 4.2x10-11 mm Hg at 20°C; 1.5x10-8 Pa = 1.13x10-10 mm Hg at 25°C 

Henry’s Law Const. 6.99x10-8 Pa-m3/mol = 6.90x10-13 atm-m3/mol at 20°C and pH 7 

Solubility in water 29.9 mg/L at pH 7 and 20°C; 33.4 in distilled water at pH 6.0-6.3 and 20°C 

Log KOW / KOW 2.51 / 324 (at pH 7) 

PKa 10.7 (loss of the H attached to the nitrogen in spirotetramat) 

Solubility in Organic 

Solvents 

Solvent g/L

n-hexane 0.055 

Dichloromethane >600 

Dimethyl Sulfoxide 200-300 

Toluene 60 

Acetone 100–120 

Ethyl acetate 67 

Ethanol 44 

UV/Vis Absorption 

Spectra 

Peak Maxima Molar Absorptivity (purity 99.2%) 

 (nm) (1000 cm2/ mol) 

 211 22.0 x 103 

 276 0.8 x 103

Spirotetramat shows various major routes of dissipation: hydrolysis in alkaline media, photolysis in 

natural water, and biodegradation in aerobic and anaerobic environments (DT50’s range <1-2.8 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-enol (theoretically a 

stoichiometric conversion), which subsequently degrades in aerobic environments to spirotetramatketohydroxy (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-enol + spirotetramat-ketohydroxy + non-extracted residues) are relatively more persistent 

than the parent or the metabolites alone (t1⁄2’s of 161-204 days for aerobic soil metabolism and 141-693 

days for aerobic aquatic metabolism). Spirotetramat is considered moderately mobile according to the 

FAO mobility classification (mean KOC of 289 mL/g), while both, spirotetramat-enol and spirotetramatketohydroxy are considered mobile (respective mean KOC’s of 55 mL/gOC and 65.3 mL/gOC). The later 

two are major transformation products in the aerobic soil metabolism studies. Spirotetramat-enol 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. 

Although both spirotetramat-enol 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. 
Page 114 of 216 

 2. Overview of Pesticide Usage

The products involved in this Section 3 (new chemical) are MOVENTOTM, BYI 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 10), grapes and small fruit 

climbing (except kiwifruit), pome fruits (Crop Group 11), stone fruits (Crop Group 12), tree nuts (Crop 

Group 14 plus Pistachio), hops, Christmas trees, 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 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 

 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: 

o Birds (also used as surrogate for terrestrial-phase amphibians and reptiles), 

o Mammals, 

o Terrestrial plants, 

o Freshwater fish (also used as a surrogate for aquatic phase amphibians), 

o Freshwater invertebrates (including sediment-dwelling species), 

o Estuarine/Marine Fish 

o Estuarine/Marine Invertebrates 

o Algae and vascular aquatic plants 

o 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 from 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 (http://cfpub.epa.gov/ecotox/), 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. 
Page 115 of 216 

Table II.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. 

Table II.2. Test Species Evaluated for Assessing Potential Ecological Effects of the Parent Spirotetramat and 

the Associated Acute Toxicity Classification 

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity 

Classification 

Birds1 Mallard (Anas platyrhynchos) 

Bobwhite quail (Colinus virginianus) Practically non-toxic 

Mammals Laboratory rat (Rattus norvegicus) Practically non-toxic 

Insects Honey bee (Apis mellifera L.) Practically non-toxic 

Freshwater fish2 

Bluegill sunfish (Lepomis macrochirus) 

Rainbow trout (Oncorhynchus mykiss) 

Carp (Cyprinus carpio) 

Fathead minnow (Pimephales promelas) 

Moderately toxic 

Freshwater invertebrates Water flea (Daphnia magna) 

Midges (Chironomus riparius) 

Slightly toxic 

Highly toxic 

Estuarine/marine fish Sheepshead minnow (Cyprinodon variegatus) Moderately toxic 

Estuarine/marine 

invertebrates 

Mysid shrimp (Americamysis bahia)

Eastern oyster (Crassostrea virginica)

Moderately toxic 

Highly toxic 

Terrestrial plants3

Monocots- Corn (Zea mays, Poaceae), oat (Avena 

sativa, Gramineae), ryegrass (Lolium perenne, 

Poaceae), onion (Allium cepa, Alliaceae), 

shattercane (Sorghum vulgare) 

Dicots- cucumber (Cucumis sativus,

Cucurbitaceae), canola (Brassica napus, 

Brassicaceae), soybean (Glycine max.), sunflower 

(Helianthus annuus L., Asteraceae), sugarbeet 

(Beta vulgaris, Chenopodiaceae), tomato 

(Lycopersicon esculentum, Solanaceae) 

Not classified 

Aquatic plants and algae 

Duckweed (Lemna gibba) 

Green algae (Pseudokirchneriella subcapitata)

Freshwater diatom (Navicular pellicullosa) 

Blue-green algae (Anabaena flos-aqua) 

Marine diatom (Skeletonema costatum) 

Not Classified 

Terrestrial invertebrates 

Honey bee (Apis mellifera) 

Predatory mite (Typhlodromus pyri) 

Parasitic wasp (Aphidius rhopalosiphi) 

Green lacewing (Chrysoperla carnea) 

Ladybird beetle (Coccinella septempunctata) 

Earthworm (Eisenia fetida) 

Practically non-toxic 

Not classified 

Not classified 

Not classified 

Not classified 

Not classified 1

 Birds represent surrogates for terrestrial-phase amphibians and reptiles. 

2

 Freshwater fish may be surrogates for aquatic-phase amphibians. 

3

 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.

a. Degradates 
Page 116 of 216 

In addition to the acute data being available for all species listed in Table II.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. 

Regarding the availability of data specifically for the degradates and aquatic organisms, there were acute 

toxicity data for spirotetramat-enol and 4-methoxycyclohexanone on rainbow trout (for enol 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-

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 BYI 08830 150 OD and Movento 240 SC in some instances. Only the data available for BYI 

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 BYI 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 BYI 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 
Page 117 of 216 

testicular/sperm toxicity study with rats, all using spirotetramat-enol. A decrease in the mean number of 

juveniles was observed in the earthworm study, increased mortality of parents was observed in the 

gamasid mite study, and testicular/sperm 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 fry survival in the 

early-life stage study with fathead minnows, decreased emergence and developmental rate in the 28-day 

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, estuarine/marine 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.F.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 means 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 118 of 216 

 1. Risk Hypothesis 

For spirotetramat, the following ecological risk hypothesis is being employed for this baseline risk 

assessment: 

Spirotetramat (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 spirotetramat 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 II.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 spirotetramat-enol 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 sprinklertype 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 octanol/water 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 LC50 (>4.183 mg/L), and the low dermal acute toxicity of the parent in 

the rat (LD50 >2000 mg/kg-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 feeding and preening. 
Page 119 of 216 

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 drift and/ or 

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

because spirotetramat has a low 1-octanol/ 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 from combined routes of exposure including root uptake could not 

be evaluated and are unclear due to the limitations of current guideline 

studies.

Figure II.1. Ecological Conceptual Model for Screening-Level Risk Assessment of

Spirotetramat Applied to Agricultural Fields

Stressor Spirotetramat total residues (spirotetramat, spirotetramat-enol, and spirotetramatketohydroxy) applied as ground/aerial spray to an agricultural field

Source/

Transport

Pathways

Volatilization

/ Wind 

Suspension

Direct

Deposition

Spray

Drift

Runoff/

Erosion

Leaching

(Infiltration/

Percolation

Source/

Exposure

Media

Terrestrial Food 

Residues (foliage, 

fruit, insects

Upland

Foliage/Soil

Riparian/

Wetland 

Foliage/Soil

Water Column, 

Sediment

Groundwater

Exposure

Point

Ingestion Direct contact/

Root Uptake

Direct contact/

Root Uptake

Gill/ Integument 

Uptake

Receptors

Attribute

Changes

Terrestrial Vertebrates 

& Invertebrates

Birds, Small Mammals,

Reptiles, Terrestrial 

Amphibians, Arthropods

Terrestrial

Upland

Plants

Individual Animals

Reduced survival

Reduced growth

Reduced reproduction

Aquatic Invertebrates

Aquatic Vertebrates

Amphibians 

Aquatic Plants

Wetland/ 

Riparian

Plants

Plant Population

Reduced survival

Reduced growth

Individual vertebrates and 

invertebrates

Reduced survival

Reduced growth

Reduced reproduction

Bioaccumulation

Plant population

Reduced

population

growth

*Dotted lines are used to signify exposure pathways that are not expected to be appreciable for spiroteramat.

 

 F. Analysis Plan 
Page 120 of 216 

 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 defined as the likelihood and magnitude of adverse ecological effect, the RQ 

method does not provide an estimated probability of effect and/or 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 I.F.1and 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 II.3. 

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

on EFED’s Tier 2 aquatic model PRZM/EXAMS. A graphical user interface (PE5), developed by the 

EPA <http://www.epa.gov/oppefed1/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, NY grapes, NC apples, MI cherries, CA almonds, OR 

Christmas trees, PA tomatoes and ID potatoes. 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 of the modeling exercise. The results from PRZM/EXAMS runs and the details on 

the models appear in the Appendix B. 
Page 121 of 216 

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 122 of 216 

Table II.3. Measures of Ecological Effects 1 and Exposure for Spirotetramat.

Assessment Endpoint Most Sensitive Surrogate 

Species Tested and Measures 

of Ecological Effect

Measures of Exposure 

Birds2 Survival Bobwhite acute oral LD50 and 

bobwhite and mallard sub-acute 

dietary LC50

Upper-bound residues on food 

items (foliar) 

Reproduction and growth Mallard chronic reproduction 

NOAEC and LOAEC 

Mammals Survival Laboratory rat acute oral LD50

Reproduction and growth Laboratory 2-generation rat 

reproduction chronic NOAEC and 

LOAEC 

Freshwater fish3 Survival Rainbow trout acute LC50 Peak EEC4

Reproduction and growth Fathead minnow chronic (early lifestage) NOAEC and LOAEC 60-day average EEC4

Freshwater invertebrates Survival Midge 48-hour acute EC50 Peak EEC4

Reproduction and growth Water flea chronic (life-cycle) 

NOAEC and LOAEC 

21-day average EEC4

Estuarine/marine fish Survival Sheepshead minnow acute LC50 Peak EEC4

Reproduction and growth No study available 60-day average EEC4

Estuarine/marine 

invertebrates 

Survival Eastern oyster acute EC50 Peak EEC4

Reproduction and growth No study available 21-day average EEC4

Terrestrial plants5 Survival and growth Monocot and dicot seedling 

emergence and vegetative vigor 

EC25, EC05, and NOAEC values Estimates of runoff and spray drift 

to non-target areas 

Insects Survival (not quantitatively 

assessed)

Parasitoid wasp LD50 Maximum application rate 

Aquatic plants (vascular) 

and algae (nonvascular) 

Survival and growth Duckweed (vascular) and 

Skeletonema costatum (nonvascular) EC50 and NOAEC values 

for growth rate and biomass 

measurements

Peak EEC 

1

LD50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; LOAEC = Lowest observed adverse effect 

concentration; LC50 = Lethal concentration to 50% of the test population; EC50/EC25 = Effect concentration to 50%/25% of the test population. 

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

3 Freshwater fish may be surrogates for amphibians (aquatic phase). 4 One in 10-year return frequency. 

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

 

III. Analysis 

A. Use Characterization 

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

maximum application rate of 0.08-0.16 lb a.i./A, and a maximum seasonal application rate of 0.16-0.40 lb 

a.i./A. According to the proposed label, the minimum interval between applications is 7-30 days, and the 
Page 123 of 216 

pre-harvest interval (PHI) ranges from 1-7 days. A summary table of all new use patterns is provided in 

Table III.1. 

Table III.1. Summary use information for spirotetramat, based on BYI 8330 150 OD 

Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 

264-xxx, proposed in both cases). Modeled uses are bolded. 

USE SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Citrus Fruit (Crop Group 

10, including calamondin, 

citrus citron, citrus hybrids 

like chironja, tangelo and 

tangor, grapefruit, kumquat, 

lemon, lime, mandarin or 

tangelo, sweet and sour 

orange, pummelo, Satsuma 

mandarin, and others)

0.16 2 0.32 21 G*, A, 

Airblast 

1 

Grape (including American 

bunch grape, muscadine grape 

and vinifera grape)

0.125 2 0.2 30 G*, A, 

Airblast 

7 

Grape and Small Fruit 

Vine Climbing (except 

kiwifruit) (including 

American bunch grape, 

muscadine grape and vinifera 

grape)

0.12 2 0.2 30 G*, A, 

Airblast 

7 

Pome Fruit (Crop Group 11, 

including apple, crabapple, 

loquat, mayhaw, pear, oriental 

pear, quince)

0.14 3 0.4 7 G*, A, 

Airblast 

7 

Stone Fruit (Crop Group 12, 

including apricot, sweet and 

tart cherry, nectarine, peach, 

plum-various kinds, plumcot 

and fresh and dried prune)

0.14 2 0.24 14 G*, A, 

Airblast 

7 

Tree Nuts (Crop Group 14 

plus pistachio, including 

almond, beechnut, Brazil nut, 

butternut, cashew, chestnut, 

chinquapin, filbert-hazelnut, 

hickory nut, macadamia nutbush nut, pecan, pistachio, 

walnut-black and English)

0.14 3 0.34 14 G*, A, 

Airblast 

7 

Hops 0.10 2 0.2 14 G*, A, 

Airblast 

7 

Christmas Trees 0.16 2 0.32 14 G*, A, 

Airblast 

N/A 
Page 124 of 216 

Table III.1. Summary use information for spirotetramat, based on BYI 8330 150 OD 

Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 

264-xxx, proposed in both cases). Modeled uses are bolded. 

USE SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Cucurbit Vegetables [Crop 

Group 9, including 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)] 

0.08 2 0.16 7 G, A, 

Chemigation

**

1 

Fruiting Vegetables (Crop 

Group 8 plus okra including 

eggplant, groundcherry, okra, 

pepinos, pepper-various kinds, 

tomatillo and tomato)

0.08 2 0.16+ 7 G, A, 

Chemigation

1 

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)

0.08 2 0.16+ 7 G, A, 

Chemigation

**

3 

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 2 0.16+ 7 G, A, 

Chemigation

**

1 
Page 125 of 216 

Table III.1. Summary use information for spirotetramat, based on BYI 8330 150 OD 

Insecticide (oil dispersion) and MOVENTOTM (suspension concentrate) labels (Reg. No. 

264-xxx, proposed in both cases). Modeled uses are bolded. 

USE SINGLE 

APP. RATE 

(lbs. a.i./A) 

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A) 

INTERVAL 

BETWEEN 

APPS. (days) 

APP. 

METHOD 

PHI 

(days) 

Potato and Other Tuberous 

and Corm Vegetables (Crop 

Subgroup 1C including 

arracacha, arrowroot, 

artichoke-Chinese and 

Jerusalem, edible canna, bitter 

and sweet cassava, chayoteroot, chufa, dasheen-taro, 

ginger, leren, potato, 

sweetpotato, tanier, turmeric, 

yam bean, true yam)

0.08 2 0.16 7 G, A, 

Chemigation*

*

7 

*High air velocity, low volume or air curtain sprayers. **Center pivot, lateral move, side roll or overhead solid set irrigation 

systems. +These are examples of crops that may have multiple seasons per year. 

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, and/or 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 petalfall on pome fruits, 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 

more than 10 feet above the crop canopy should be avoided. 3) Avoid spraying during conditions of low 
Page 126 of 216 

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 III.2: Structure of spirotetramat 

Structure Mass 

[g/mol] Chemical name 

N

H

O

O

O

O

CH3

H3C H3C

O

H3C

373.45 

IUPAC: cis-3-(2,5-dimethylphenyl)-8-methoxy-2-

oxo-1-azaspiro[4.5]dec-3-en-4-yl ethyl carbonate 

CAindex: Carbonic acid, cis-3-(2,5-dimethylphenyl)-

8-methoxy-2- oxo-1-azaspiro[4.5]dec-3-en-4-yl 

ethyl ester

Table III.3 summarizes physical/ chemical and environmental fate/ transport properties of spirotetramat 

(and transformation products). 

Table III.3. Summary of physical/ chemical and environmental fate and transport properties of 

spirotetramat and its major transformation products.

PARAMETER VALUE(S) (units) COMMENT 

 Solubility (20 oC) At pH 4, 7 and 9, 33.5, 29.9 and 19.1 mg/L, respectively; in distilled water (pH 6.0-6.3), 33.4 mg/L 

 Solubility of Spirotetramat in 

Organic Solvents (20 oC) 

Ethanol = 44 g/L; n-hexane = 0.055 g/L; toluene = 60 g/L; dichloromethane = >600 g/L; acetone = 100-

120 g/L; ethylacetate = 67 g/L; dimethyl sulfoxide = 200-300 g/L 

 Vapor Pressure (20 oC)/ 

 Henry’s Law constant 

5.6x10-9 Pa = 4.2x10-11 mm Hg 

6.99x10-8 Pa-m3

/mol = 6.90x10-13 Atm-m3/mol 

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

and S
Page 127 of 216 

Table III.3. Summary of physical/ chemical and environmental fate and transport properties of 

spirotetramat and its major transformation products.

PARAMETER VALUE(S) (units) COMMENT 

 pKa Spirotetramat 10.7 Loss of the H attached to the nitrogen in 

spirotetramat 

 Octanol-Water Partition Coefficient 

Spirotetramat (KOW, at 20 oC) 324 – 

 Spirotetramat-enol 

 Solubility; KOW and log KOW; pKa

Solubility at 20°C, pH 5 = 0.09 g/L, pH 7 = 2.7 g/L, pH 8 = 28 g/L; KOW and log KOW at pH 5 = 109 and 

2.0, respectively, at pH 7 = 2.1 and 0.3, respectively, at pH9 = 0.06 and -1.3, respectively; pKa = 5.2 

 Spirotetramat-ketohydroxy 

 Solubility; KOW and log KOW; pKa 

Solubility =0.228 g/L; KOW and log KOW = 20 and 1.3, respectively at pH 7; pKa = 11.0 

 Hydrolysis Half-life Spirotetramat 

 [pH 4, 7, 9; (20 and 25 oC)] 

SFO; pH 4, 25°C, t1/2 = 32.5 days 

pH 4, 20°C, t1/2 = 47.6 days 

pH 7, 25°C, t1/2 = 8.6 days 

pH 7, 20°C, t1/2 = 13.1 days

pH 9, 25°C, t1/2 = 0.32 days 

SFO=single first order kinetics. 

Major metabolite – spirotetramat-enol. 

 Hydrolysis Half-life of 

spirotetramat-enol (pH 4, 7, 9; 50 oC) 

Stable 

The study was conducted for 5 days at 50 oC. . 

 Aqueous Photolysis Half-life t1/2 = 14.4 Phoenix, AZ days (pH 5.0) vs.

[t1/2 = 0.74 Phoenix, AZ days in natural water at pH 7.9] 

SFO=single first order kinetics. All values 

are corrected for dark control. Different 

metabolites were observed in buffered 

solution and natural water. 

 Soil Photolysis Half-life A fine SL and a L; Dimethyl benzoic acid & methoxycyclohexanone observed in irradiated samples only: Supplemental study, the dark control 

degraded faster than the irradiated 

samples. 

 Aerobic Soil Metabolism Half-life 

of parent spirotetramat 

Half-lives for spirotetramat (DFOP-best fit)

For FL SL, SL, SiL and Si; t1/2’s = 0.30, 0.24, 0.26 and 0.09 

days, respectively 

Upperbound 90th percentile = 0.298 days

DT90 (for DFOP kinetics) = 1.26, 0.89, 

0.97 and 0.34, respectively. 

DFOP=double first order kinetics. 

 Aerobic Soil Metabolism Half-life 

study conducted with spirotetramatenol 

DT50’s derived from the study (days) 

Chemical: enol ketohydroxy MA-amide 

Kinetics: SFORB SFO SFO 

FL SL 0.05 16.7 5.4 

SL 0.02 4.2 1.1 

SiL 0.16 5.1 1.8 

Si 0.02 1.5 0.3 

Upperbound 

90th perc. 

0.117 12.38 3.99 

For FL SL, SL, SiL and Si, 

DT90 for enol = 0.17, 0.07, 0.53 and 0.06 

days, respectively. 

Respective DT90 for ketohydroxy= 55.6, 

13.9, 16.9 and 5.1 days. 

Respective DT90 for MA-amide= 18.1, 3.6, 

6.3 and 1 days. 

SFORB=single first order reverse binding 

kinetics. SFO=single first order kinetics. 

 Aerobic Soil Metabolism Half-life 

of 4-methoxycyclohexanone 

Half-lives for 4-methoxycyclohexanone (SFO)

<1day (obs.), <1day (obs.) and 0.6 days, for SiL, L and FL 

LS, respectively 

DT90 = 1.8 days for LS; DT90 could not be 

calculated for SiL and L. SFO=single first 

order kinetics. 

 Anaerobic Soil Metabolism 

 Half-life 

SL; t1/2 = 0.06 days (FOMC) 

The spirotetramat-enol reached a maximum amount at the 

last test interval; spirotetramat-ketohydroxy was a maximum 

at 1 day interval. 

DT90 = 1.33 days. 

FOMC=first order multi-compartment 

 Anaerobic Aquatic Metabolism 

 Half-life 

KS CL sediment; t1/2 = 2.8 days (SFO) DT90 = 9.3 days. 

SFO=single first order kinetics. 
Page 128 of 216 

Table III.3. Summary of physical/ chemical and environmental fate and transport properties of 

spirotetramat and its major transformation products.

PARAMETER VALUE(S) (units) COMMENT 

 Aerobic Aquatic Metabolism 

 Half-life 

Spirotetramat* SFO, total system: 

For L and LS sediment; t1/2 =1.06 and 1.05 days, 

respectively. 

90th percentile = 1.070 days 

Rates for spirotetramat-enol**, SFO: 

For L and LS sediment; t1/2 = 59.0 and 37.9 days, 

respectively 90th percentile = 80.92 days 

Rates for spirotetramat-ketohydroxy: could not be evaluated, 

there is no decline or last test interval with maximum value 

*Respective spirotetramat DT90‘s = 3.52 

and 3.50 days. 

**Respective spirotetramat–enol DT90‘s = 

196 and 126 days. 

SFO=single first order kinetics.four 

compartment model 

 Organic Carbon Partition 

Coefficient (KOC)and (Kd) – parent 

spirotetramat 

 Organic Carbon Partition 

Coefficient (KFOC) – parent 

spirotetramat (mg/kg)/(mg/L)1/n; 

(KF) – parent spirotetramat 

(mg/kgOC)/(mg/L)1/n

soil KOC Kd KFOC KF

LS 184 4.38 201 4.79 

SL 437 3.80 435 3.78 

SiL 201 4.69 176 4.10 

Mol SL 385 3.58 435 4.05 

L 237 5.52 159 3.70 

mean 289 4.39 na na 

Mol = Molino 

Soil Partition Coefficient (Kd) 

Organic Carbon Partition 

Coefficient (KOC) – spirotetramatenol 

Range 0.52-0.86 mL/g 

27, 65, 29 and 99; mean KOC = 55 mL/gOC

(mobile) 

SL, L, SiL and SL, respectively. 

Estimated values from the soil column 

leaching study: 

 Soil Partition Coefficient (Kd) 

 Organic Carbon Partition 

Coefficient (KOC) for spirotetramatketohydroxy 

0.560, 0.529, 1.10, 0.867, 2.28 mL/g

Mean = 1.067 mL/g

43.1, 48.1, 42.0, 99.7, 93.7 mL/gOC

Mean = 65.3 mL/gOC

(mobile) 

SL, SiL, SiL, SL and CL, respectively 

 Soil Partition Coefficient (Kd) 

Organic Carbon Partition 

Coefficient (KOC) for spirotetramatMA-amide 

0.071, 0.064, 0.116, 0.119, 0.126 mL/g; mean = 0.099 mL/g

4.2, 7.0, 5.0, 25.6, 5.6 mL/gOC

(mobile to highly mobile) 

SL, SiL, SiL, LS and L, respectively 

 Organic Carbon Partition 

Coefficient (KOC), obtained using 

HPLC method, for spirotetramat-enol 

dimer 1 and spirotetramat-enol dimer 

2 

dimer 1, at pHs 6.0 and 1.7, 1771 and 1477 mL/gOC, 

respectively; a mean of 1624 mL/gOC (slightly mobile) 

dimer 2, at pHs 6.0 and 1.7, 3115 and 3301 mL/gOC, 

respectively; a mean of 3208 mL/gOC (slightly mobile) 

– 

 Terrestrial Field Dissipation 

 Half-life for parent spirotetramat 

 Half-life for total residues of 

spirotetramat-enol + spirotetramatketohydroxy and for total residues of 

spirotetramat + spirotetramat-enol + 

spirotetramat-ketohydroxy 

DT50’s (days), Upper 0-45 cm Soil Depth, SFO 

Chemical parent 

enol + 

ketohydroxy 

All 

residues 

NY LS, bg 0.5 31.6 23.4 

FL S, bg 0.9 6.6 7.6 

FL S, cr 1.0 4.8 5.7 

CA SL, bg 1.0 7.6 8.4 

CA SL, cr 1.0 8.7 10.2 

WA SL, bg 0.4 5.2 6.3 

WA SL, cr 0.3 4.6 5.0 

FL S; Cropped; bush beans ‘Blue Lake’; 

CA SL; Cropped; tomatoes ‘Germain’s 

Seed’; WA LS; Cropped; yellow sweet 

Spanish onions. 

SFO=single first order kinetics.or SFO in 

series. 

bg = bareground; cr = cropped. 

 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 
Page 129 of 216 

environments (half-dissipation times or DT50’s range <1-2.8 days). Hydrolysis in neutral and acidic 

environments and 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-enol 

(product of cleavage of the ester link), which further 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-enol is more persistent in aquatic 

environments and relatively stable in anaerobic media. Spirotetramat’s total residues of concern 

(spirotetramat + spirotetramat-enol + 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 confirm 

the findings of the laboratory studies, with spirotetramat dissipating with DT50’s in the range of 0.3-1.0 

days, and total residues of spirotetramat + spirotetramat-enol + spirotetramat-ketohydroxy dissipating 

much more slowly. 

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

and their relatively low level of binding (relatively low partition coefficients, Kd’s and KOC’s), and low 

affinity to organic matter (1-octanol/ water partition coefficient or KOW’s≤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 and/ 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 drift (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 (4.2x10-11

mm Hg and 6.90x10-13 Atm-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 (KOW) 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-octanol/ 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-octanol/ water partition 

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

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

bioconcentrate/ bioaccumulate and do not partition highly with organic matter.

 c. Degradation 

Hydrolysis is relevant for the overall degradation/ 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 25°C, 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. 
Page 130 of 216 

Spirotetramat photolyzes relatively rapidly in sterile natural water. Spirotetramat photolyzes with 

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-enol (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 (≥4.8%): 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 

(DT50’s) of <1 day in three soils from the EU and one domestic SL soil (range 0.09-0.30 days). 

Furthermore, spirotetramat-enol also degraded relatively quickly, with DT50’s of <1 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-enol degradation study, spirotetramat-enol showed a biphasic 

kinetic behavior with >80% of AR degraded by day 1 posttreatment and slower degradation from 1 to 119 

days after treatment or DAT (from 10.7 – 17.2% of the applied radioactivity or AR to 2.7 – 6.1% of AR). 

DT50’s for spirotetramat-ketohydroxy (maximum 24.0% of AR at 1 day) were derived from the results 

obtained in the study conducted on spirotetramat-enol (range of DT50’s 1.5-16.7 days). Also, DT50’s 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-enol (range of DT50’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-enol (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 

non-extracted residues showed a heterogeneous composition, with a high portion of fulvic acids in both 

studies. In an outdoor metabolism study spirotetramat degraded with calculated half dissipation times 

(DT50’s) of 1.2 and 2.9 days. Spirotetramat-enol was a maximum of 7.8%. The degradates spirotetramatglyoxylic 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 ≤16.8% of 

the AR. Figure III.1 provides the proposed degradation pathway for spirotetramat, including all the 

transformation products (major and minor). 
Page 131 of 216 

In aquatic environment, under aerobic aquatic conditions, spirotetramat degraded with calculated DT50’s 

of ~1 day in the total system. Spirotetramat was mostly associated with the aqueous phase. The 

metabolite spirotetramat-enol 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. 

DT50’s for spirotetramat-enol were derived from the study results (range of DT50’s 37.9-59.0 days). 

Minor transformation products were ≤8.7% 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 <<1 day. The major 

degradates were spirotetramat-enol, which increased throughout the study (maximum 54.6% at 180 days) 

and spirotetramat-ketohydroxy (maximum 19.3% at 1 day). Mineralization was very low. Nonextractable 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 

DT50 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 III.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, 

spirotetramat-photo-cyclopentyl, spirotetramat-photo-2-methylcarbonate, spirotetramat-photo-2-

hydroxymethyl, spirotetramat-photo-2-formyl. Spirotetramat-enol 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-enol (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-enol occurs to yield spirotetramatdesmethyl-enol and subsequently spirotetramat-oxo-enol (minor products). Furthermore, oxidative 

spirotetramat-enol dimerization may occur to yield spirotetramat-enol dimer 1 and spirotetramat-enol 

dimer 2. The degradation products in most soil and water/ 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-enol 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-

/trans-isomer ratio. 

Instead of half-lives derived using the log-linear relationship, except where indicated, half-dissipation 

times (DT50’s), obtained from other kinetic models were used (e.g. single first order [SFO], double first 
Page 132 of 216 

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-enol degraded 

with a biphasic behavior) and were used in agreement of the EPA with AGES and PMRA. Table III.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 Kd values ranging from 3.58-5.52 mL/g, 

KOC values between 184-437 mL/gOC (mean 289 mL/gOC), KF values ranging from 3.70-4.79 

(μg/gOC)/(μg/mL)1/n, KFOC values ranging from 159-435 (μg/gOC)/(μg/mL)1/n [mean 281 

(μg/gOC)/(μg/mL)1/n], and 1/n 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-enol 

because the chemical was labile during the adsorption phase. The mobility of spirotetramat-enol 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-enol was a total of 0.1-2.8%. The estimated KOC values for spirotetramat-enol were 

between 27-99 mL/gOC (mean 55 mL/gOC) over four soil types (mobile), with Kd values ranging from 0.52 

to 0.86 mL/g. The degradate spirotetramat-ketohydroxy is mobile in five sterilized soils, with Kd values 

ranging from 0.529-2.28 mL/g, KOC values ranging from 43.1-99.7 mL/gOC (mean 65.3 mL/gOC), KF

values ranging from 0.516-2.21 (μg/g)/(μg/mL)1/n, KFOC values between 41.0-99.1 (μg/gOC)/(μg/mL)1/n

[mean 63.7 (μg/gOC)/(μg/mL)1/n] and 1/n values close to unity (range 0.915-0.929, mean 0.922). The KOC

values were similar to the Freundlich adsorption constants KFOC. The degradate spirotetramat-MA-amide 

is mobile to highly mobile in five viable soils, with Kd values ranging from 0.064-0.179 mL/g, KOC results 

ranging from 4.2-25.6 mL/gOC (mean 9.6 mL/gOC), KF values ranging from 0.075-0.179 (μg/g)/(μg/mL)1/n, 

KFOC values 4.4-25.5 (μg/gOC)/(μg/mL)1/n [mean 9.3 (μg/gOC)/ (μg/mL)1/n] and 1/n 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-enol 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-enol are not expected to 

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

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 (DT50’s) of 0.3-1.0 days 

(estimated for the residues of spirotetramat present in the 0-45 cm soil layer). These values are consistent 
Page 133 of 216 

with the 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-enol and spirotetramat-ketohydroxy were calculated. Those residues 

presented calculated DT50’s of 4.6-31.6 days (0-45 cm soil layer). In addition, the combined residues of 

spirotetramat, spirotetramat-enol and spirotetramat-ketohydroxy were found to degrade at moderate rates 

with DT50’s ranging from 5.0-23.4 days (0-45 cm soil layer). Spirotetramat and its residues remained in 

the top 0-15 cm soil layer, except for detections in the 15-30 cm soil layer at the Florida site; the 

chemicals observed above the LOQ in 15-30 cm soil layer were spirotetramat-enol and spirotetramatketohydroxy 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 (KOW) is 324, indicating a low tendency to 

bioaccumulate/ bioconcentrate. In addition, for spirotetramat-enol and spirotetramat-ketohydroxy their 

KOW are also low: 2.1 and 20, respectively, pointing towards a low tendency to bioaccumulate/ 

bioconcentrate. 

 
Page 134 of 216 

NH

O

O

O O

CH3

CH3

H3C

NH

O

O

CH3

CH3

OH

CO2

N

H

O

CH3

CH3

OH

COOH

NH

HO

O

CH3

CH3

OCH3

NH

HO

O

CH3

CH3

OH

NH

HO

O

CH3

CH3

O

NH

O

CH3

CH3

NH

O

O

CH3

CH3

OH

OH

NH

O

O

CH3

CH3

OH

O

N

H

O

CH3

CH3

CH O COOH 3

CH3

O

COOH

OCH3

NH

O

O

CH3

CH3

O

OCH3

OCH3

OCH3

NH

HO

O

CH3

CH3

OCH3

OCH3

OCH3 OCH3

NH

O

O

R

R1

OH

OCH3

NH

HO

O

CH3

CH3

OH

OCH3

BYI08330

Enol

Ketohydroxy

Bound residues

(- 2 H)

Enol-dimer 1

2

MA-amide

Desmethyl-enol

Oxo-enol

Hydrolysis

Oxidation

x 2

Hydrolysis

Desmethylation

Oxidation

Enol-dimer 2

Desmethylation

ketohydroxy

DesmethylOxo-ketohydroxy

Oxidation

*

Benzoic 

acid**

Methoxy 

Molecule cyclohexanone

cleavage

Glyoxylic amide**

Oxidation

***

x 2

(- 2 H)

Oxidation

Oxidation

Ketohydroxycarboxy

Oxidation

R,R1= -CH3, -COOH

Oxidation

Oxidation

cleavage

Molecule

Dihydroxy

Oxidation

Hydratization

*: 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. III.1. Proposed metabolic pathway for spirotetramat in soil. 
Page 135 of 216 

 h. Uncertainties and Issues 

Uncertainties and issues were discussed in Section I.F.1, 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-enol 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-enol 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-enol 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-enol 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-enol and spirotetramat-ketohydroxy), the non-extracted residues were added as if they were 

persistent compounds. 
Page 136 of 216 

Table III.4: Chemical name, structure, molecule mass and occurrence of major metabolites of 

spirotetramat. 

Substance Chemical name Structure 

Mole 

mass 

(g/mol) 

Occurrence 

(maximum amounts 

based on mean of replicates)

[% of AR]** 

Spirotetramatenol 

CAS: cis-3-(2,5-

Dimethylphenyl)-4-

hydroxy-8-methoxy1-azaspiro[4.5]dec3-en-2-one 

301.39 

Aerobic soil: 100.0 (0 d)

(most conservative assumption) 

Aerobic outdoor: 7.8 (7 d) 

Anaerobic soil: 54.6 (180 d) 

Field soil: naa

Soil photolysis: 10.1 (1 d) 

Hydrolysis (pH 7): 91.8 (29 d) 

Photolysis water: 81.9 (1 d) 

Aerobic water/sed.: 79.7 / 41.2

Spirotetramatketohydroxy 

CAS: cis-3-(2,5-

Dimethylphenyl)-3-

hydroxy-8- 

methoxy-1-

azaspiro[4.5]decan2,4-dione 

317.39 

Aerobic soil: 24.0 (1 d) 

Aerobic outdoor: 25.3 (14 d) 

Anaerobic soil: 19.3 (1 d) 

Field soil: naa

Soil photolysis: 20.9 (2 d) 

Hydrolysis: - 

Photolysis water: - 

Aerobic water/sed.: 17.4 / 42.8

a

 Not applicable owing to distinct storage instability of spirotetramat-enol (degrading to spirotetramat-ketohydroxy during frozen storage) 

** Bolded values at or above 10% of the applied. 

2. Measures of Aquatic Exposure 

a. Aquatic Exposure Modeling 

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

on EFED’s Tier II aquatic model PRZM/EXAMS. A graphical user interface (PE5 v. 5.0, November 15, 

2006), developed by the EPA <http://www.epa.gov/oppefed1/models/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 or 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 III.5 and III.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 III.7 and III.8. 

Selection of PRZM scenarios 
Page 137 of 216 

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 PRZM/ 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 PRZM/ 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 Kd 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 25°C), the hydrolysis may have played a role in the degradation of spirotetramat. However, the 

extent of such reaction is unknown. 

One PRZM/ EXAMS run was set for the total residues of spirotetramat + spirotetramat-enol + 

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 KOC

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-enol 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 spirotetramat-enol + spirotetramat-ketohydroxy + non-extracted residues (from the 

aerobic soil metabolism study conducted with spirotetramat-enol). Similarly, the aerobic aquatic 
Page 138 of 216 

metabolism input parameter was estimated for the total residues of spirotetramat + spirotetramat-enol + 

spirotetramat-ketohydroxy + non-extracted residues. The water solubility of spirotetramat-ketohydroxy 

was considered the most adequate input parameter. 

Table III.5. Input Parameters for PRZM/ EXAMS for the Estimation of the EECs of Spirotetramat 

Parameter (units) Value(s) Sources Comments 

Output File Name SPIROTET --- --- 

Chemical Name Spirotetramat Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Crop Names FL citrus 

NY grapes 

NC apples 

MI cherries 

CA almond 

OR Xmas trees 

PA tomatoes 

ID potatoes 

Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Application Rate 

kg a.i./ha

FL citrus 0.179 x 2 

NY grapes 0.0841 and 0.140 

NC apples 0.134 and 0.157 

 x 2 

MI cherries 0.112 and 0.157 

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 

Label 

 

Label application rate 

lb a.i./A:

FL citrus 0.16 x 2 

NY grapes 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 

OR Xmas trees 0.16 x 2 

PA tomatoes 0.08 x 2 

ID potato – 0.08 x 2 

Day of Application (day-month)/ 

pre-harvest interval FL citrus 24-11 

NY grapes 01-09 

NC apples 25-08 

MI cherries 28-06 

CA almond 14-07 

OR Xmas trees 01-06 

PA tomatoes 01-08 

ID potato 15-08 

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 

Estimated from metadata file and 

proposed labels. 

Minimum Number of 

Applications Allowed at the 

Maximum Application Rate 

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 

Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Minimum Interval between 

Applications (days) 

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 

Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

CAM (Chemical application 

method) 

2 Label 2, linear foliar based on crop 

canopy 

IPSCND (Flag indicating the 

disposition of pesticide remaining 

on foliage after harvest) 

1 1, pesticide remaining on foliage is 

converted to surface application to 

the top soil layer 

DEPI = Incorporation Depth (cm) 0.0 Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 
Page 139 of 216 

Table III.5. Input Parameters for PRZM/ EXAMS for the Estimation of the EECs of Spirotetramat 

Parameter (units) Value(s) Sources Comments 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Kd (mL/g) 4.39 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

The average Kd value, as per EFED 

guidance on input parameters for 

PRZM/EXAMS dated 2/28/02. 

The Kd value represents better the 

mobility of spirotetramat (relative 

standard deviation is smaller). 

Aerobic Soil Metabolism (days) 0.298 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Represents the 90th percentile of 

the upper confidence bound on the 

mean of four half-life values (FL 

SL; t1/2 = 0.30 days, SL; t1/2 = 0.24 

days, SiL; t1/2 = 0.26 days, Si; t1/2 = 

0.09 days) (DFOP best fit kinetics). 

Method of Application Ground and aerial Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Buffer Zone (ft.) N/A Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Application Efficiency (fraction) 0.99 for ground application 

0.95 for aerial application 

--- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02. 

Spray Drift (fraction) 0.01 for ground application 

0.05 for aerial application 

--- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

Solubility in Water (ppm) 335 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

10X the actual solubility as per 

EFED guidance on input 

parameters for PRZM/EXAMS. 

Aerobic Aquatic Metabolism 

(days) 

1.07 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Represents the 90th percentile of 

the upper confidence bound on the 

mean of two half-life values (L 

sediment; t1/2 =1.06 days, LS 

sediment; t1/2 =1.05 days) (SFO 

kinetics). 

Anaerobic Aquatic Metabolism 

(days) 

8.4 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Determined by multiplying the 

available half-life (2.8 days) by 3 

to account for the uncertainty 

associated with using a single 

value (SFO kinetics). 

Hydrolysis at pH 7 half-life (days) 13.1 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 (SFO kinetics). 

Aqueous Photolysis @ pH 7 

(days) 

14.4 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

t1/2 = 14.4 Phoenix, AZ days, 

maximum dark-controlled 

available value (SFO kinetics). 

Molecular Weight (g/mole) 373.45 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

--- 

Vapor Pressure (torr or mmHg) 4.2x10-11 OECD Monograph --- 
Page 140 of 216 

Table III.5. Input Parameters for PRZM/ EXAMS for the Estimation of the EECs of Spirotetramat 

Parameter (units) Value(s) Sources Comments 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Henry’s Law Constant 

(Atm-m3

/mol) 

6.90x10-13

OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

--- 

Environment pond298.exv --- Default for pond scenario, as 

Field Size EPA Pond --- opposed to index reservoir. 

Runoff none --- --- 

FEXTRC, Foliar extraction 0.5 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

PLDKRT, Decay rate on foliage 0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

PLVKRT, Volatilization rate from 

foliage 

0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

UPTKF, Uptake factor 0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

Write Benthic Pore Water 

Concentrations? 

Yes --- For information only 

Table III.6. Input Parameters for PRZM/EXAMS for the Estimation of the EECs of Spirotetramat + 

Degradates (Total Residues: Spirotetramat + Spirotetramat-enol + Spirotetramat-ketohydroxy + 

Non-Extracted Residues) 

Parameter (units) Value(s) Sources Comments 

Output File Name SPIROTET --- --- 

Chemical Name Spirotetramat Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Crop Names NC apples Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Application Rate 

Kg a.i./ha 

NC apples 0.134 and 0.157 

 x 2 

Label 

 

Label application rate 

lb a.i./A: 

NC apples 0.12 and 0.14 x 2 

Day of Application (day-month)/ 

pre-harvest interval NC apples 25-08 

Label PHI: 

NC apples 7 days 

Estimated from metadata file and 

proposed labels. 

Minimum Number of 

Applications Allowed at the 

Maximum Application Rate 

NC apples 3 Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Minimum Interval between 

Applications (days) 

NC apples 7 Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

CAM (Chemical application 

method) 

2 Label 2, linear foliar based on crop 

canopy 

IPSCND (Flag indicating the 

disposition of pesticide remaining 

on foliage after harvest) 

1 1, pesticide remaining on foliage is 

converted to surface application to 

the top soil layer 
Page 141 of 216 

Table III.6. Input Parameters for PRZM/EXAMS for the Estimation of the EECs of Spirotetramat + 

Degradates (Total Residues: Spirotetramat + Spirotetramat-enol + Spirotetramat-ketohydroxy + 

Non-Extracted Residues) 

Parameter (units) Value(s) Sources Comments 

DEPI = Incorporation Depth (cm) 0.0 Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

KOC (mL/gOC) 65.32 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

The average KOC value, as per 

EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02. The KOC value 

represents better the mobility of 

spirotetramat-ketohydroxy, the 

terminal degradate and the most 

stable (relative standard deviation 

is smaller). 

Aerobic Soil Metabolism (days) Total Residues 222.3 days OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Represents the 90th percentile of 

the upper confidence bound on the 

mean of four half-life values for 

the total residues of the enol and 

the ketohydroxy (all possible 

significant figures used, use of loglinear parameters) (t1/2 = 203.82 

days, t1/2 = 169.02 days, t1/2 = 

161.16 days, t1/2 = 203.82 days; 

mean = 184.455 days; std. dev. 

22.58984 days). 

Method of Application Aerial Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Buffer Zone (ft.) N/A Label Proposed labels BYI 8330 150 OD 

Insecticide (oil dispersion) and 

MOVENTOTM (suspension 

concentrate) labels (Reg. No. 264-

XXX, proposed, in both cases) 

Application Efficiency (fraction) 0.95 for aerial application --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02. 

Spray Drift (fraction) 0.05 for aerial application --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

Solubility in Water (ppm) 2280 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

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 

PRZM/EXAMS. 

Aerobic Aquatic Metabolism 

(days) 

Total Residues 563.3 days OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

For the parent + enol + 

ketohydroxy, represents the 90th

percentile 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 

days, mean = 369.025 days (use of 

log-linear parameters). 

Anaerobic Aquatic Metabolism 

(days) 

OVERALL – Stable OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

The enol is stable and there are no 

adequate data on the ketohydroxy; 

the most conservative scenario is 

presumed. 
Page 142 of 216 

Table III.6. Input Parameters for PRZM/EXAMS for the Estimation of the EECs of Spirotetramat + 

Degradates (Total Residues: Spirotetramat + Spirotetramat-enol + Spirotetramat-ketohydroxy + 

Non-Extracted Residues) 

Parameter (units) Value(s) Sources Comments 

Hydrolysis at pH 7 half-life (days) OVERALL – Stable OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

The enol is stable and there are no 

adequate data on the ketohydroxy; 

the most conservative scenario is 

presumed. 

Aqueous Photolysis @ pH 7 

(days) 

OVERALL – Stable OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

The enol and the ketohydroxy are 

not photodegradates; therefore, in 

the absence of data, the most 

conservative scenario is presumed. 

Molecular Weight (g/mole) 373.45 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Assumed to be the one for the 

parent. 

Vapor Pressure (torr or mmHg) 4.2x10-11 OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Assumed to be the same than for 

the parent, due to similar 

structures. 

Henry’s Law Constant 

(Atm-m3

/mol) 

6.90x10-13

OECD Monograph 

Annex B. 

Spirotetramat. B.8 Fate 

and Behaviour 

Assumed to be the same than for 

the parent, due to similar 

structures. 

Environment pond298.exv --- Default for the standard pond 

scenario, as opposed to index 

reservoir. 

Field Size EPA Pond --- 

Runoff none --- --- 

FEXTRC, Foliar extraction 0.5 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

PLDKRT, Decay rate on foliage 0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

PLVKRT, Volatilization rate from 

foliage 

0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

UPTKF, Uptake factor 0 --- EFED guidance on input 

parameters for PRZM/EXAMS 

dated 2/28/02 

Write Benthic Pore Water 

Concentrations? 

Yes --- For information only 

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 3x2.8 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 PRZM/ 

EXAMS (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-enol + spirotetramatketohydroxy) were assumed to be stable to hydrolysis, aqueous photolysis and anaerobic aquatic 

metabolism (the most conservative case). These residues appeared to degrade relatively slowly, 
Page 143 of 216 

compared to the parent alone (input values 222.3 days for aerobic soil metabolism and 563.3 days for 

aerobic aquatic metabolism). 

Modeling Results

Table III.7. Estimated exposure concentrations of spirotetramat (ppb) in the 

water column. 

Crop Scenario a/App. 

rate/No. Apps/Int. 

Between Apps. Peak 21-day 60-day 

FL citrus aerial/ 

0.32/ 2/ 21 0.452 0.0558 0.0347 

NY grapes aerial/ 

0.2/ 2/ 30 0.352 0.0690 0.0325 

NC apples aerial/ 

0.4/ 3/ 7 0.573 0.154 0.0563 

MI cherries aerial/ 

0.24/ 2/ 14 0.393 0.0726 0.0260 

CA almonds aerial/ 

0.34/ 3/ 14 0.395 0.0659 0.0284 

OR Xmas trees aerial/ 

0.32/ 2/ 14 0.450 0.113 0.0412 

PA tomatoes aerial/ 

0.16/ 2/ 7 0.254 0.0482 0.0169 

ID potatoes aerial/ 

0.16/ 2/ 7 0.244 0.0475 0.0167 

FL citrus ground/ 

0.32/ 2/ 21 0.110 0.0182 0.00940 

NC apples ground/ 

0.4/ 3/ 7 0.372 0.0602 0.0227 

CA almonds ground/ 

0.34/ 3/ 14 0.0812 0.0132 0.00569 

OR Xmas trees ground/ 

0.32/ 2/ 14 0.0901 0.0226 0.00825 a

 A chosen representative scenario for spray applications of spirotetramat to agricultural crops. 

Application rate in lb a.i./A and interval between applications in days.

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). 

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 75-80% 

decreases for the other three scenarios: 0.452, 0.395 and 0.450 ppb vs. 0.110, 0.0812 and 0.0901 ppb for 

the FL citrus, CA almond and OR Christmas trees scenarios, respectively). 

Table III.8. Estimated exposure concentrations of spirotetramat plus 

degradates of concern (spirotetramat-enol and spirotetramat-ketohydroxy) 

(ppb) in the water column. 

Crop Scenario a/App. 

rate/No. Apps/Int. 

Between Apps. Peak 21-day 60-day 

NC apples aerial/ 

0.4/ 3/ 7 11.4 11.1 10.8 a

 A chosen representative scenario for spray applications of spirotetramat to agricultural crops. 

Application rate in lb a.i./A and interval between applications in days.
Page 144 of 216 

The EECs for the total residues (spirotetramat + spirotetramat-enol + 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 (11.4 vs. 0.573 ppb). The 21-day EEC 

for the total residues was 72 times higher (11.1 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 

http://www.epa.gov/oppefed1/models/terrestrial/. 

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, spirotetramat-enol, and spirotetramatketohydroxy. 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, 

spirotetramat-enol, 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. 
Page 145 of 216 

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 

171-4) 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 leaf/whole 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 half-lives 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 fruit scenario based on total residues approach) can be 

found in Appendix F. 

Table III.9. Input parameters and upper-bound and mean estimated environmental concentrations (EECs) 

generated using T-REX v1.3.1 for the maximum spirotetramat spray application scenarios of various crops. 1

Use 

Max. Single 

App. Rate 

(lbs a.i./A) 

Min. 

Interval 

(Days) 

Max. No. 

Apps. 

Per Year 

EECs in ppm (upper-bound / mean) 

Short Grass Long Grass 

Broadleaf 

Plants, 

Small 

Insects 

Fruits, 

Pods, 

Seeds, 

Large 

Insects 

Parent only 2

Pome fruit 0.14 7 3 43.10 / 15.26 19.75 / 6.46 24.24 / 8.08 2.69 / 1.26 

Xmas trees 0.16 14 2 40.43 / 14.32 18.53 / 6.06 22.74 / 7.58 2.53 / 1.18 

Citrus fruit 0.16 21 2 38.87 / 13.77 17.81 / 5.83 21.86 / 7.29 2.43 / 1.13 
Page 146 of 216 

Table III.9. Input parameters and upper-bound and mean estimated environmental concentrations (EECs) 

generated using T-REX v1.3.1 for the maximum spirotetramat spray application scenarios of various crops. 1

Use 

Max. Single 

App. Rate 

(lbs a.i./A) 

Min. 

Interval 

(Days) 

Max. No. 

Apps. 

Per Year 

EECs in ppm (upper-bound / mean) 

Short Grass Long Grass 

Broadleaf 

Plants, 

Small 

Insects 

Fruits, 

Pods, 

Seeds, 

Large 

Insects 

Tree nuts 0.14 14 3 35.47 / 12.56 16.26 / 5.32 19.95 / 6.65 2.22 / 1.03 

Stone fruit 0.14 14 2 35.38 / 12.53 16.21 / 5.31 19.90 / 6.63 2.21 / 1.03 

Grape 0.125 30 2 30.06 / 10.64 13.78 / 4.51 16.91 / 5.64 1.88 / 0.88 

Climbing 3 0.12 30 2 28.85 / 10.22 13.22 / 4.33 16.23 / 5.41 1.80 / 0.84 

Hops 0.1 14 2 25.27 / 8.95 11.58 / 3.79 14.21 / 4.74 1.58 / 0.74 

Cucurbit 4 0.08 7 2 23.61 / 8.36 10.82 / 3.54 13.28 / 4.43 1.48 / 0.69 

Total Residues 2

Pome fruit 0.14 7 3 52.44 / 18.57 24.03 / 7.87 29.50 / 9.83 3.28 / 1.52 

Xmas trees 0.16 14 2 44.55 / 15.78 20.42 / 6.68 25.06 / 8.35 2.78 / 1.30 

Citrus fruit 0.16 21 2 40.86 / 14.47 18.73 / 6.13 22.99 / 7.66 2.55 / 1.19 

Tree nuts 0.14 14 3 39.85 / 14.11 18.26 / 5.98 22.41 / 7.47 2.49 / 1.16 

Stone fruit 0.14 14 2 38.98 / 13.81 17.87 / 5.85 21.93 / 7.31 2.44 / 1.14 

Grape 0.125 30 2 30.59 / 10.84 14.02 / 4.59 17.21 / 5.74 1.91 / 0.89 

Climbing 3 0.12 30 2 29.37 / 10.40 13.46 / 4.41 16.52 / 5.51 1.84 / 0.86 

Hops 0.1 14 2 27.85 / 9.86 12.76 / 4.18 15.66 / 5.22 1.74 / 0.81 

Cucurbit 4 0.08 7 2 26.89 / 9.52 12.32 / 4.03 15.12 / 5.04 1.68 / 0.78 1

 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 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. 

2

 For foliar dissipation, 16 foliar half-life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and one 

non-guideline study (MRID 46904507) for both the parent spirotetramat as well as for the total residues (parent spirotetramat, spirotetramat-enol, and 

spirotetramat-ketohydroxy). Assuming these values are 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 are 3.3 and 5.3 days, respectively. 3

 This group includes grapes and other small vine climbing fruit. 4

 This group includes: cucurbit vegetables, fruiting vegetables, leafy vegetables, brassica (cole) leafy vegetables, and potato and other tuberous and 

corm vegetables.

By 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 upper-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 III.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 upper-bound residues and 0.78 to 

18.57 ppm for mean residues. Concentrations were highest on the surfaces of short grass for the 
Page 147 of 216 

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 III.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 fraction 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 labelspecified, the entered runoff fraction 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 <10 ppm, 10 to 100 ppm, or >100 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-enol 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. 

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 
Page 148 of 216 

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. 

Table III.10. Estimated environmental concentrations (EECs) of total spirotetramat (parent + degradates) 

residues on plants following the maximum exposure scenario of all crops using the TerrPlant model (lb 

a.i./A). 

EECs 

Application Method; 

Rate 

Runoff to 

Dry Areas a 

Runoff to 

Semi-aquatic 

Areas b 

Drift c Total Loading 

to Dry Areas d 

Total Loading 

to Semiaquatic Areas e

Aerial Spray Application, 

Unincorporated; 

0.16 lb a.i./A 

0.008 0.08 0.008 0.016 0.088 

a Sheet runoff 

b

 Channelized Runoff 

c

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

 EEC = Sheet Runoff +Drift 

e

 EEC = Channelized Runoff + Drift

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 

freshwater fish (2000+) and bird (680+) species in the United States. For mammals, acute studies are 

usually limited to Norway rat or the house mouse. Estuarine/marine 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. 

In general, categories of acute toxicity ranging from “practically nontoxic” to “very highly toxic” have 

been established for aquatic organisms (based on LC50 and EC50 values), mammals (based on LD50 

values), avian species (based on and LD50 and LC50 values), and non-target insects (based on LD50 values 
Page 149 of 216 

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 mg/kg-body weight; 

LC50>5000 mg/kg-diet) and mammals (LD50>2000 mg/kg-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 mg/kg-dry 

weight soil). Only a 14-day study with 4-methoxy-cyclohexanone (↓ body weight; NOAEC=125 mg/kgdry weight soil) and an 8-week study with spirotetramat-enol (↓ reproduction; NOAEC=32 mg/kg-dry 

weight soil) demonstrated any toxic effects to earthworms. 

Although spirotetramat can be classified as practically non-toxic to honey bees (LD50 range = 91.7 to 162 

μg 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 LR50 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 LR50 = 0.0003 lb a.i/A 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=0.08 lb a.i./A), dry weight (EC25 =0.07 lb a.i./A; NOAEC=0.04 lb a.i./A), and fresh weight 

(EC25 =0.20 lb a.i./A; NOAEC=0.13 lb a.i./A) of corn; reduced dry weight of ryegrass (EC25 =0.15 lb 

a.i./A; NOAEC=0.08 lb a.i./A); reduced fresh weight of canola (EC25 =0.17 lb a.i./A; NOAEC=0.06 lb 

a.i./A); and reduced fresh weight of oats (EC25 =0.19 lb a.i./A; NOAEC=0.13 lb a.i./A). 

Spirotetramat can be classified as moderately toxic to freshwater (LC50 range= 1.41 to 2.59 mg a.i./L) and 

estuarine/marine 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 estuarine/marine invertebrates (EC50

range= 0.85 to 5.5 mg a.i./L) on an acute basis. Although there is no toxicity classification scheme for 
Page 150 of 216 

aquatic vascular and non-vascular plants, toxic effects were demonstrated in the available studies with 

duckweed (effects on yield and growth; lowest EC50=4.49 mg a.i./L, NOAEC=1.54 mg a.i./L) and algae 

(effects on biomass and growth rate; lowest EC50=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 mg/kg-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 mg/kg-diet included reductions in # of 14-day survivors (↓22%), # of 

viable 14-day embryos (↓18%), # of live embryos (↓18%), and # of eggs hatched (↓22%). 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 mg/kg-diet (LOAEC of 6000 

mg/kg-diet). Observed effects at the LOAEC included: decreased body weight and body weight gain 

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 (F1 males and females). 

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

the early-life stage study with fathead minnows (NOAEC=0.534 mg a.i./L, LOAEC=1.16 mg a.i./L); 

decreased emergence (NOAEC=0.1 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. 

Table III.11. The effects measurement endpoints used for quantitative risk estimation purposes for spirotetramat. 
Page 151 of 216 

Taxonomic Group Assessment Endpoint Effects Measurement Endpoint 

Birds

Survival Bobwhite quail LD50 >2000 mg/kg-body weight 

Bobwhite quail LC50 >5000 mg/kg-diet

Reproduction and growth Mallard NOAEC <28.8 mg/kg-diet 1

Mammals 

Survival Rat LD50 >2000 mg/kg- body weight 

Rat LC50 >2000 mg/kg-diet 2

Reproduction and growth Rat NOAEC= 1000 mg/kg-diet (70.7 mg/kg- body weight)

Freshwater fish 

Survival Rainbow Trout 96-hour LC50= 1.41 mg a.i./L 3

Reproduction and growth Fathead minnow NOAEC= 0.534 mg a.i./L 

Freshwater 

invertebrates 

Survival Midge 48-hour EC50 = 0.66 mg a.i./L 3

Reproduction and growth Water flea NOAEC= 2.0 mg a.i./L 

Estuarine/marine fish 

Survival Sheepshead minnow 96-hour LC50= 1.96 mg a.i./L 

Reproduction and growth No study available 

Estuarine/marine 

invertebrates 

Survival Eastern oyster 96-hour EC50= 0.85 mg a.i./L

Reproduction and growth No study available 

Terrestrial plants 

Seedling emergence: 

Non-listed Monocots 

Listed Monocots 

EC25>0.16 lb a.i./A 

NOAEC>0.16 lb a.i./A 

Seedling emergence: 

Non-listed Dicots 

Listed Dicots 

EC25>0.16 lb a.i./A 

NOAEC>0.16 lb a.i./A 

Vegetative Vigor: 

Non-listed Monocots 

Listed Monocots 

EC25= 0.06 lb a.i./A 

NOAEC= 0.02 lb a.i./A 

Vegetative Vigor: 

Non-listed Dicots 

Listed Dicots 4

EC25>0.16 lb a.i./A 

NOAEC>0.16 lb a.i./A 

Aquatic plants 

(vascular) 

& 

Algae 

 (non-vascular) 

Survival and growth: Non-listed Duckweed (vascular) 96-hour EC50= 4.49 mg a.i./L 

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

Survival and growth: Listed Duckweed (vascular) 96-hour NOAEC = 1.54 mg a.i./L 

Skeletonema costatum (non-vascular) 96-hour NOAEC=0.124 

mg a.i./L 1 Measurement endpoint was based on a ~6.58% reduction in mean hatchling bodyweight at the lowest test level. 2

A conservative estimate of dietary acute toxicity was generated using the existing rat oral LD50 and assuming a conservative ingestion rate of 100 percent of 

the body weight. The resulting estimated dietary acute toxicity endpoint is >2000 mg/kg-diet [(>2000 mg/kg-bw)(1 kg-bw/1kg-diet) = >2000 mg/kg-diet]. 3 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. 4 There were some effects on canola in one vegetative vigor study. A slightly higher, but definitive EC25=0.17 lb a.i./A was generated, and so was a lower 

NOAEC = 0.06 lb a.i./A. However, the more conservative EC25 (>0.16 lb a.i./A) and the associated NOAEC were selected for use. 
Page 152 of 216 

2. Aquatic Toxicity

a. Acute Effects

Table III.12. Summary of the toxicity data available to evaluate the acute effects of spirotetramat on aquatic organisms. 

Test organism Test Substance Test 

condition Time Test concentration Endpoint NOEC [mg a.i./L] 

EC50/LC50 

[mg a.i./L] Reference 

Freshwater Fish 

Oncorhynchus mykiss

(Rainbow trout)

Spirotetramat 

Technical Semi-static 96 hr Meanmeasured Mortality 0.825 2.54 Dorgerloh, 

2004a 

Oncorhynchus mykiss 

(Rainbow trout)

Formulation OD 

150 

(15.3 % a.i.)

Static 96 hr Nominal Mortality 0.38 1.41 Nieden, 

2005b 

Oncorhynchus mykiss 

(Rainbow trout)

Spirotetramatenol Staticb 96 hr Nominal Mortality 100 > 100 Nieden, 

2005a 

Cyprinus carpio 

(Common carp)

Spirotetramat 

Technical Semi-static 96 hr Meanmeasured Mortality 1.02 2.59 Dorgerloh, 

2004b 

Lepomis macrochirus 

(Bluegill sunfish)

Spirotetramat 

Technical Semi-static 96 hr Nominal Mortality 0.5 2.2 Dorgerloh, 

2005a 

Danio rerio 

(Zebra fish)

Spirotetramat-4-

Methoxycyclohe

xanone 

Staticb 96 hr Nominal Mortality 100 > 100 Neuhahn, 

2006a 

Estuarine/Marine Fish 

Cyprinodon 

variegatus 

(Sheepshead 

minnow)

Spirotetramat 

Technical 

Flowthrough 96 hr Meanmeasured Mortality 0.52 1.96 Banman& 

Lam, 2005 

Freshwater Invertebrates 

Daphnia magna 

(Water flea)

Spirotetramat 

Technical Static 48 hr Meanmeasured Immobility 20.3 > 42.7 Dorgerloh, 

2005c 

Daphnia magna 

(Water flea)

Spirotetramat-4-

Methoxycyclohe

xanone

Staticb 48 hr Nominal Immobility 100 > 100 Neuhahn, 

2006b 

Daphnia magna 

(Water flea)

Spirotetramatenol Staticb 48 hr Nominal Immobility 100 > 100 Dorgerloh, 

2005d 

Chironomus riparius 

(Midge)

Spirotetramat 

Technical 

Static 

(water-only) 48 hr Meanmeasured Mortality <0.53 1.30 Dorgerloh, 

2005g 

Chironomus riparius 

(Midge)

Formulation OD 

150 

(15.3 % a.i.) 

Static 

(water-only) 48 hr Meanmeasured Mortality 0.36 a 0.66 Dorgerloh, 

2006b 

Chironomus riparius 

(Midge)

Spirotetramat-4-

Methoxycyclohe

xylamino 

carboxylic acid 

Static b

(water-only) 48 hr Nominal Mortality 100 > 100 Dorgerloh, 

2007b 

Chironomus riparius 

(Midge)

Spirotetramatenol Static 

(water-only) 48 hr Nominal Mortality 17.1a

 74.9 Dorgerloh, 

2005h 

Chironomus riparius 

(Midge)

Spirotetramatketohydroxy Static 

(water-only) 48 hr Nominal Mortality 23.9 a > 100 Dorgerloh, 

2006a 

Chironomus riparius 

(Midge)

Spirotetramat-4-

Methoxycyclohe

xanone 

Static b

(water-only) 48 hr Nominal Mortality 100 > 100 Dorgerloh, 

2007a 

Estuarine/Marine Invertebrates 

Americamysis bahia 

(Saltwater mysid)

Spirotetramat 

Technical 

Flowthrough 96 hr Meanmeasured Mortality < 0.73 4.27 Cafarelle, 

2005a 

Crassostrea virginica 

(Eastern oyster)

Spirotetramat 

Technical 

Flowthrough 96 hr Meanmeasured 

Shell 

deposition 0.33 0.85 Cafarelle, 

2005b 

Non-Vascular Aquatic Plants 

P. subcapitata 

(Green alga) 

Spirotetramat 

Technical Static 72 hr Meanmeasured 

Biomass 

Growth rate 1.46 6.58 

8.15 

Dorgerloh, 

2004c 

P. subcapitata 

(Green alga) 

Formulation OD 

150 

(15.3 % a.i.) 

Static 72 hr Nominal 

Biomass 

Growth rate 

2.02 

6.56 

> 8.2 

Dorgerloh, 

2006c 

P. subcapitata 

(Green alga) 

Spirotetramatenol Static 72 hr Nominal Biomass 

Growth rate 31 > 100 Dorgerloh, 

2005f 

Navicular 

pellicullosa 

(Diatom-freshwater) 

Spirotetramat 

Technical Static 96 hr Meanmeasured 

Biomass 

Growth rate 

0.19 

1.00 

4.05 

15.0 

Kern&Lam, 

2005 
Page 153 of 216 

Table III.12. Summary of the toxicity data available to evaluate the acute effects of spirotetramat on aquatic organisms. 

Test organism Test Substance Test 

condition Time Test concentration Endpoint NOEC [mg a.i./L] 

EC50/LC50 

[mg a.i./L] Reference 

D. subspicatus 

(Green alga) 

Spirotetramat-4-

Methoxycyclohe

xanone

Staticb 72 hr Nominal Biomass 

Growth rate 100 > 100 Weyers, 2006 

Anabaena flos-aqua 

(Blue-green alga) 

Spirotetramat 

Technical Static 96 hr Meanmeasured 

Biomass 

Growth rate 

5.68 

15.1 

15.2 

> 15.1 

Kern&Lam, 

2006 

Skeletonema 

costatum 

(Diatom-marine) 

Spirotetramat 

Technical Static 96 hr Meanmeasured 

Biomass 

Growth rate 0.124 0.36 0.96 

Banman& 

Lam, 2006 

Vascular Aquatic Plants 

Lemna gibba 

(Duckweed) 

Spirotetramat 

Technical Semi-static 7 d Meanmeasured 

Yield 

Growth rate 1.54 4.49 

6.21 

Dorgerloh, 

2005j 

Lemna gibba 

(Duckweed) 

Spirotetramatenol Static 7 d Meanmeasured Yield 

Growth rate 

0.95 

3.05 

5.4 

19.3 

Dorgerloh, 

2005k 

Test conc.: test concentration based on mean measured (mm) or nominal (nom) concentration 

a) LC10, NOEC was not determined 

b) Limit test 

b. Chronic/Reproductive Effects 

Table III.13. Summary of the toxicity data available to evaluate the chronic/reproductive effects of spirotetramat on aquatic organisms. 

Test 

Organism 

Test 

Substance 

Test 

Conditions Time Test Concentration Endpoint NOEC [mg/L] 

LOEC

[mg//L] Reference 

Freshwater Fish 

Pimephales 

promelas 

Fathead 

minnow

Spirotetramat 

Technical Flowthrough

33 

days Mean-measured 

Hatchability 

Fry survival 

Growth 

1.16 

0.534 

1.16 

> 1.16 

1.16 

> 1.16 

Dorgerloh 

2005b 

Estuarine/Marine Fish 

No data available 

Freshwater Invertebrates 

Daphnia 

magna 

Water flea 

Spirotetramat 

Technical Semi-static 21 

days Nominal 

Mortality adults 

Reproduction 

Growth 

2.0 

5.0 

5.0 

5.0 

12.5 

12.5 

Dorgerloh 

2005e 

Chironomus 

riparius 

Midge (larvae)

Spirotetramat 

Technical

Static 

(spiked 

water) 

28 

days Nominal Emergence 

Development 

0.1 

0.8 

0.2 

1.6 

Dorgerloh 

2005i 

Estuarine/Marine Invertebrates 

No data available 

3. Terrestrial Toxicity 

a. Terrestrial Vertebrates

i. Acute Effects 
Page 154 of 216 

Table III.14. Summary of the toxicity data available to evaluate the acute/sub-acute effects of spirotetramat on terrestrial vertebrates. 

Test Type Test Substance Test Organism Measurement Endpoint Effects Reference 

Mammals 

Acute oral LD50

Spirotetramat 

Technical 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Eigenberg 

(2004) 

Acute oral LD50

Formulation OD 150 

(15.3 % a.i.) 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Schüengel 

(2005) 

Acute oral LD50

Formulation SC 240 

(22.4% a.i.) 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg -bw None Schüengel 

(2005) 

Acute oral LD50

Spirotetramatketohydroxy 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Schüengel 

(2005) 

Acute oral LD50

Spirotetramatdesmethylketohydroxy 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Schüengel 

(2006) 

Acute oral LD50

Spirotetetramat-dihyroxy 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Schüengel 

(2006) 

Acute oral LD50

Spiroetetramat-monohyroxy 

Ratus norvegicus 

(Rat, female) LD50 > 2000 mg/kg-bw None Schüengel 

(2005) 

Birds 

Acute oral LD50

Spirotetramat 

Technical 

Colinus 

virginianus 

(Northern 

bobwhite)

LD50 > 2000 mg/kg-bw 

NOAEL < 500 mg/kg-bw a

NOAEL = 1000 mg/kg-bw a

Diarrhea, soft 

excrement, reduced 

feed consumption 

Decreased body 

weight, and 

2 mortalities at the 

highest dose 

Barfknecht, 

2003 

Acute dietary 

LC50

Spirotetramat 

Technical 

Colinus 

virginianus 

(Northern 

bobwhite)

LC50 > 5000 mg/kg-diet 

NOAEC= 1250 mg/kg-diet 

No treatment-related 

mortalities 

Decreased body 

weight gain and feed 

consumption 

Barfknecht, 

2004 

Acute dietary 

LC50

Spirotetramat 

Technical 

Anas 

platyrhynchos 

(Mallard)

LC50 > 6050 mg/kg-diet 

NOAEC < 344 mg/kg-diet 

No treatment-related 

mortalities 

Decreased body 

weight gain and feed 

consumption 

Stoughton, 

2005 

a

 Not statistically determined. 

ii. Chronic/Reproductive Effects 
Page 155 of 216 

Table III.15. Summary of the toxicity data available to evaluate the chronic/reproductive effects of spirotetramat on terrestrial 

vertebrates. 

Test Type Test Substance Test 

Organism Measurement Endpoint Effects Reference 

Mammals 

2-generation 

reproduction 

Spirotetramat 

Technical 

Ratus 

norvegicus 

(Rat) 

NOAEC = 1000 mg/kg-diet 

NOAEL = 70.7 mg/kg-bw 

Decreased body weight 

and body weight gain in 

both generations, 

reproductive performance 

in males, food 

consumption, and kidney 

histopathology and 

decreased kidney weights. 

Young (2006) 

Birds 

Avian 

reproduction 

Spirotetramat 

Technical 

Colinus 

virginianus 

(Northern 

bobwhite) 

NOAEC = 264 mg/kg-diet 

Decreased body weight 

gain of adult females, 

mean hatchling body 

weight, and embryos/eggs 

set (%) endpoint. 

Sabbert & 

Nuessle, 

2006a 

Avian 

reproduction 

Spirotetramat 

Technical 

Anas 

platyrhynchos

(Mallard) 

NOAEC < 89 mg/kg-diet 

Decreased mean hatchling 

body weight and doseresponse in foot lesions 

Sabbert & 

Nuessle, 

2006b 

Avian 

reproduction 

Spirotetramat 

Technical 

Anas 

platyrhynchos

(Mallard) 

NOAEC < 28.8 mg/kg-diet Decreased mean hatchling 

body weight 

Temple et al., 

2006 

 b. Terrestrial Invertebrates 
Page 156 of 216 

 

Table III. 16. Summary of the toxicity data available to evaluate the effects of spirotetramat on non-target terrestrial invertebrates. 

Test Species Exposure route Test substance Endpoint Exposure 

Duration 

Measurement Endpoint Reference 

Apis mellifera 

(Honey bee) 

Oral 

Contact 

Spirotetramat 

technical Mortality 48 hours LD50 > 107.3 μg a.i./bee

LD50 > 100 μg a.i./bee 

Schmitzer, 

2004a 

Apis mellifera 

(Honey bee) 

Oral 

Contact 

Spirotetramat 

OD150 Mortality 48 hours LD50 = 91.7 μg a.i./bee 

LD50 = 162 μg a.i./bee Barth, 2005a 

Apis mellifera 

(Honey bee)

Feeding test, 

mixed in sucrose 

solution at 

0.0144 % a.i. 

Each colony 

received 1kg 

until gone. 

Spirotetramat 

OD100 

Mortality 

Behavior 

Brood 

effects 

Fed until 

gone. 

Available up 

to 7 days. 

Observation 

made for 21 

days. 

Slightly increased mortality of 

adults and pupae. 

No adverse effect. 

High termination rate in two of 

three colonies. 

Schur, 2004a 

Apis mellifera 

(Honey bee)

Feeding test, 

mixed in sucrose 

solution at 

0.0144 % a.i. 

Each colony 

received 1kg 

until gone. 

Spirotetramat 

SC 240 

Mortality 

Behavior 

Brood 

effects 

Fed until 

gone. 

Available up 

to 7 days. 

Observations 

made for 21 

days. 

Increased adult mortality. 

No adverse effect. 

Termination of brood development 

with tendency to recover. 

Schur, 2004b 

Apis mellifera 

(Honey bee)

Semi-field study, 

2 applications on 

crop before 

flowering at 

0.064 lb a.i./A + 

2 xapplications at 

0.064 lb a.i./A 

after flowering or 

2 applications at 

0.086 lb a.i./A 

Spirotetramat 

OD150 

Mortality 

Behavior 

Brood 

effects 

Observations 

made for 28 

days. 

No adverse effect. 

No adverse effect. 

No adverse effect. 

Schur, 2006 

Apis mellifera 

(Honey bee) 

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 

Spirotetramat 

OD100 

Mortality 

Behavior 

Brood 

effects 

Observation 

made for 23 - 

29 days. 

No adverse effect. 

No adverse effect. 

No adverse effect. 

Schur, 2005 

Aphidius 

rhopalosiphi 

(Parasitoid 

wasp)

Contact with 

dried residues on 

treated glass 

plates 

Spirotetramat 

OD150 Mortality 48 hours LD50 = 0.102 lb a.i./A Waltersdorfer 

2005a 

Typhlodromus 

pyri 

(Predatory 

mite)

Contact with 

dried residues on 

treated glass 

plates 

Spirotetramat 

OD150 Mortality 7 days LD50 = 0.0003 lb a.i./A Waltersdorfer 

2005b 

Aphidius 

rhopalosiphi 

(Parasitoid 

wasp)

Contact with 

dried residues on 

treated barley 

plants 

Spirotetramat 

OD150 

Mortality 

Reproductio

n 

48 hours 

LD50 > 0.26 lb a.i./A 

NOEC = 0.26 lb a.i./A 

Waltersdorfer 

2006a 
Page 157 of 216 

Typhlodromus 

pyri 

(Predatory 

mite)

Contact with 

dried residues on 

treated bean 

leaves 

Spirotetramat 

OD150 

Mortality 

Reproductio

n 

7 days 

LD50 = 0.0014 lb a.i./A 

NOAEC < 0.0001 lb a.i./A 

Waltersdorfer 

2005c 

Typhlodromus 

pyri 

(Predatory 

mite)

Contact with 

dried residues 

(acute and aged 

on treated apple 

leaves 

Spirotetramat 

OD150 Mortality 7 days 

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 

Waltersdorfer 

2006c 

Chrysoperla 

carnea 

(Green 

lacewing)

Contact with 

dried residues on 

treated bean 

leaves 

Spirotetramat 

150 OD 

Mortality 

Reproductio

n 

Exposure until 

pupation 

LD50 > 0.26 lb a.i./A 

NOEC = 0.26 lb a.i./A 

Roehlig 2005 

Coccinella 

septempunctata

(Ladybird 

beetle) 

Contact with 

dried residues on 

treated bean 

leaves and aphids 

Spirotetramat 

150 OD 

Mortality 

Reproductio

n 

Exposure until 

pupation 

LD50 > 0.26 lb a.i./A 

NOEC = 0.26 lb a.i./A 

Waltersdorfer 

2006b 

Eisenia fetida 

(Earthworm)

Contaminated 

soil contact 

Spirotetramat 

Mortality 

Body weight 

14 days 

EC50/LC50> 1000 mg/kg-dw soil 1

NOAEC= 1000 mg/kg-dw soil 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

LecheltKunze 2004 

Eisenia fetida 

(Earthworm)

Contaminated 

soil contact 

Spirotetramatketohydroxy 

Mortality 

Body weight 

14 days 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

LecheltKunze 2005 

Eisenia fetida 

(Earthworm)

Contaminated 

soil contact 

4-Methoxycyclohexanone 

Mortality 

Body weight 

14 days 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 125 mg/kg-dw soil 

Leicher 2008 

Eisenia fetida 

(Earthworm)

Contaminated 

soil contact 

Spirotetramatenol 

Mortality 

Body weight 

Reproductio

n 

4 weeks 

4 weeks 

8 weeks 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

EC50/LC50> 1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

EC50/LC50=1269 mg/kg-dw soil 

NOAEC= 32 mg/kg-dw soil 

Moser & 

Scheffczyk 

2005 

Hypoaspis 

aculeifer 

(Gamasid mite) 

Contaminated 

soil contact 

Spirotetramatenol 

Mortality 

Reproductio

n 

28 days 

EC50/LC50>1000 mg/kg-dw soil 

NOAEC= 316 mg/kg-dw soil 

EC50/LC50>1000 mg/kg-dw soil 

NOAEC= 1000 mg/kg-dw soil 

Moser & 

Scheffczyk 

2005 

1 Units are mg/kg dry weight of soil. 

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 spirotetramat’s pollinator compatibility. These data are discussed briefly in the “Risk 

Description” section of the assessment. 

c. Terrestrial Plants 
Page 158 of 216 

Table III. 17. Summary of the toxicity data available to evaluate the effects of spirotetramat on terrestrial plants. 1

Test 

system Species Tested Observed Effects / Measurement Endpoints Reference 

Vegetative 

vigour: 

Tier 1 

Monocots 

Zea mays(Corn) 

Avena sativa (Oats) 

Corn dry weight ↓56.9% at 0.26 lb a.i./A 

Oats dry weight ↓56.6% at 0.26 lb a.i./A 

Gosch & 

Nguyen 

2006a 

Dicots 

Cucumis sativus (Cucumber) 

Brassica napus (Canola) 

Glycine max (Soybean) 

Helianthus annuus (Sunflower)

Cucumber dry weight ↓41.3% at 0.26 lb a.i./A 

Cucumber survival ↓5% at 0.26 lb a.i./A 

Canola dry weight ↓83.3% at 0.26 lb a.i./A 

Soybean dry weight ↓40.2% at 0.26 lb a.i./A 

Sunflower dry weight ↓43.1% at 0.26 lb a.i./A 

Vegetative 

vigour: 

Tier 1I 

Monocots 

Zea mays(Corn) 

Avena sativa (Oats) 

Lolium perenne (Ryegrass)

Allium cepa (Onion) 

Corn plant length: NOAEC = 0.04 lb a.i./A; EC25=0.09 lb a.i./A 

Corn dry weight: NOAEC = 0.04 lb a.i./A; EC25=0.07 lb a.i./A 

Ryegrass plant length: NOAEC = 0.08 lb a.i./A; EC25>0.16 lb a.i./A 

Ryegrass dry weight: NOAEC = 0.08 lb a.i./A; EC25=0.15 lb a.i./A 

No other statistical effects: NOAEC = 0.16 lb a.i./A; EC25 >0.16 lb a.i./A Christ & 

Dicots Lam 2006a 

Cucumis sativus (Cucumber) 

Brassica napus (Canola) 

Glycine max (Soybean) 

Helianthus annuus (Sunflower) 

Beta vulgaris (Sugarbeet) 

Lycopersicon esculentum (Tomato)

No statistical effects: NOAEC = 0.16 lb a.i./A; EC25 >0.16 lb a.i./A 

Vegetative 

vigour: 

Tier 1I 

Monocots 

Zea mays(Corn) 

Avena sativa (Oats) 

Corn fresh weight: NOAEC=0.13 lb a.i./A; EC25 =0.20 lb a.i./A 

Oats fresh weight: NOAEC=0.13 lb a.i./A; EC25 =0.19 lb a.i./A 

No other statistical effects: NOAEC = 0.16 lb a.i./A; EC25 >0.16 lb a.i./A Friedrich 

2006 

Dicots 

Brassica napus (Canola)

Canola fresh weight: NOAEC=0.06 lb a.i./A; EC25 =0.17 lb a.i./A 

No other statistical effects: NOAEC = 0.16 lb a.i./A; EC25 >0.16 lb a.i./A 

Vegetative 

Vigour: 

Tier II 2

Monocots 

Sorghum vulgare (Shattercane) 

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

No other statistical effects: NOAEC = 0.19 lb a.i./A; EC25 >0.19 lb a.i./A Gosch 

2007 

Seedling 

emergence: 

Tier I 

Monocots 

Zea mays(Corn) 

Avena sativa (Oats) 

Dicots 

Cucumis sativus (Cucumber) 

Brassica napus (Canola) 

Glycine max (Soybean) 

Helianthus annuus (Sunflower)

No adverse effects ≥25% at 0.26 lb a.i./A Gosch & 

Nguyen 

2006b 
Page 159 of 216 

Table III. 17. Summary of the toxicity data available to evaluate the effects of spirotetramat on terrestrial plants. 1

Test 

system Species Tested Observed Effects / Measurement Endpoints Reference 

Seedling 

emergence: 

Tier I 

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) 

No adverse effects ≥25% at 0.16 lb a.i./A Christ & 

Lam 2006b 

1

 All studies conducted with formulation Spirotetramat OD 150, unless otherwise indicated. 2

 Conducted with Spirotetramat SC 240. 

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 + spirotetramat-enol + 

spirotetramat-ketohydroxy) were obtained from the Tier 2 aquatic model PRZM/EXAMS 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 

21-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 160 of 216 

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 estuarine/marine water-column dwelling animals can be 

found in Table IV.1, 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. 

Table IV.1. Comparison of acute RQs for freshwater and estuarine/marine fish and invertebrates based on the 

crop/use scenario that resulted in the highest peak EECs of all modeled scenarios and the most sensitive acute 

toxicity values for each taxonomic group. a , b

Acute Aquatic Animal RQs d

Residues c Peak EEC 

(μg a.i./L) 

Freshwater 

Invertebrates 

Freshwater 

Fish 

Estuarine/Marine 

Invertebrates 

Estuarine/Marine 

Fish 

Parent only 0.573 0.0009 0.0004 0.0007 0.0003 

Total 11.4 0.0173 0.0081 0.0134 0.0058 

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. b

 Toxicity values are based on studies with midges (Chironomus riparius) for freshwater invertebrates (EC50 = 660 μg a.i./L), bluegill sunfish (Lepomis 

macrochirus) for freshwater fish (LC50 = 1410 μg a.i./L), eastern oysters (Crassostrea virginica) for estuarine/marine invertebrates (EC50 = 850 μg 

a.i./L), and sheepshead minnow (Cyprinodon variegatus) for estuarine/marine fish (LC50 = 1960 μg a.i./L). c

 24-hour peak EEC values generated from PRZM/EXAMS are reported for the parent spirotetramat only as well as for total residues (i.e., residues for 

the parent plus degradates of concern). 

d All RQs are below the acute risk (0.5), acute restricted use (0.1), and acute endangered species (0.05) LOCs.

Table IV.2. Comparison of chronic RQs for freshwater fish and invertebrates based on the crop/use 

scenario that resulted in the highest 21- and 60-day EECs of all modeled scenarios and the most sensitive 

chronic toxicity values for each taxonomic group. a , b

Chronic Aquatic Animal RQs d

Residues c

21-day EEC 

μg a.i./L 

60-day EEC 

μg a.i./L 

Freshwater Invertebrates Freshwater Fish 

Parent only 0.154 0.0563 0.0001 0.0001 

Total 11.1 10.8 0.0056 0.0202 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 21-day 

and 60-day EECs.

b

 Chronic toxicity values are based on studies with water fleas (Daphnia magna) for freshwater invertebrates (NOAEC = 2000 μg a.i./L) and 

fathead minnows (Pimephales promelas) for freshwater fish (NOAEC = 534 μg a.i./L). c

 21-day and 60-day EEC values generated from PRZM/EXAMS are reported for the parent spirotetramat only as well as for total residues (i.e., 

residues for the parent plus degradates of concern). 

d All RQs are below the chronic risk LOC (1).

Table IV.3. Comparison of acute RQs for aquatic vascular and non-vascular plants based on the crop/use 

scenario that resulted in the highest peak EECs of all modeled scenarios and the most sensitive acute toxicity 

values for each taxonomic group. a , b

Acute Aquatic Plant RQs d

Non-endangered Endangered 

Residues c Peak EEC 

(μga.i./L) 

Non-vascular 

Plants RQ 

Vascular Plants 

RQ 

Non-vascular 

Plants RQ 

Vascular Plants 

RQ 

Parent only 0.573 0.0016 0.0001 0.0046 0.0004 

Total 11.4 0.0317 0.0025 0.0919 0.0074 

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 
Page 161 of 216 

EECs.

b

 Toxicity values are based on studies with duckweed (Lemna gibba) for vascular plants (EC50 = 4620 μg a.i./L; NOAEC=1540 μg a.i./L) and 

marine diatoms (Skeletonema costatum) for non-vascular plants (EC50 = 360 μg a.i./L; NOAEC=124 μg a.i./L). EC50 values are used to derive 

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

 24-hour peak EEC values generated from PRZM/EXAMS are reported for the parent spirotetramat only as well as for total residues (i.e., 

residues for the parent plus degradates of concern). 

d All RQs are below the acute LOCs for aquatic plants (1).

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. 

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 (LD50 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://www.epa.gov/oppefed1/models/terrestrial/. All 

measurement endpoints used to derive RQs for terrestrial animals are summarized in Table III.11. 

a. Risks to Non-Target Birds 

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 Assessment”) 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. 

It must be noted that chronic risk estimates for birds are based upon a non-definitive NOAECof <28.8 

mg/kg-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 
Page 162 of 216 

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 non-definitive NOAEC (<28.8 mg/kg-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 mg/kg-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 >1.50) 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 fruit 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. 

Table IV.4. Dose- and dietary-based acute RQs for birds exposed to spirotetramat based on upper-bound total 

residues on short grass as calculated by T-REX for the maximum exposure scenario. a

Type of 

Analysis 

Size 

Class (g) 

LC50 or Adjusted Acute LD50 b Food Item 

Short Grass 

EEC b Acute RQ c, d

Dose-based 

20 >1441 mg/kg-bw 59.72 mg/kg-bw <0.04 

100 >1834 mg/kg-bw 34.05 mg/kg-bw <0.02 

1000 >2591 mg/kg-bw 15.25 mg/kg-bw <0.01 

Dietary-based N/A >5000 mg/kg-diet 52.44 mg/kg-diet <0.01 

a The maximum exposure scenario was the pome fruit scenario, with a maximum single application rate of 0.14 lb a.i./A, a 7-day application interval, 

and a maximum of 3 applications. 

b 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. 

c The most sensitive LD50 and LC50 values for birds 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 . 

d

All acute RQs are below the acute LOCs for non listed species (0.5), restricted use (0.2), and listed species (0.1). 

Table IV.5. Dietary-based chronic RQs for birds exposed to spirotetramat based on upper-bound residues 

(total and parent-only) on short grass as calculated by T-REX for the all exposure scenarios. a

Use 

Max. 

Single 

App. 

Rate 

lbs 

a.i./A 

Min. 

Interval 

Days 

Max. 

No. 

Apps. 

Per 

Year 

Short Grass Tall Grass Broadleaf Plants 

/Small Insects 

Fruits/Pods/ 

Seeds/Large 

Insects 

EEC 

mg/kgdiet RQ 

EEC 

mg/kgdiet RQ 

EEC 

mg/kgdiet RQ 

EEC 

mg/kgdiet RQ 

Parent-Only Residues

Pome 

fruit 0.14 7 3 43.10 >1.50b 19.75 >0.69 24.24 >0.84 2.69 >0.09 

Xmas 

trees 0.16 14 2 40.43 >1.40b 18.53 >0.64 22.74 >0.79 2.53 >0.09 
Page 163 of 216 

Citrus 

fruit 0.16 21 2 38.87 >1.35b 17.81 >0.62 21.86 >0.76 2.43 >0.08 

Tree nuts 0.14 14 3 35.47 >1.23b 16.26 >0.56 19.95 >0.69 2.22 >0.08 

Stone 

fruit 0.14 14 2 35.38 >1.23b 16.21 >0.56 19.90 >0.69 2.21 >0.08 

Grape 0.125 30 2 30.06 >1.04b 13.78 >0.48 16.91 >0.59 1.88 >0.07 

Climbing 0.12 30 2 28.85 >1.00b 13.22 >0.46 16.23 >0.56 1.80 >0.06 

Hops 0.1 14 2 25.27 >0.88 11.58 >0.40 14.21 >0.49 1.58 >0.05 

Cucurbit 0.08 7 2 23.61 >0.82 10.82 >0.38 13.28 >0.46 1.48 >0.05 

Total Residues

Pome 

fruit 0.14 7 3 52.44 >1.82b 24.03 >0.83 29.50 >1.02b 3.28 >0.11 

Xmas 

trees 0.16 14 2 44.55 >1.55b 20.42 >0.71 25.06 >0.87 2.78 >0.10 

Citrus 

fruit 0.16 21 2 40.86 >1.42b 18.73 >0.65 22.99 >0.80 2.55 >0.09 

Tree nuts 0.14 14 3 39.85 >1.38b 18.26 >0.63 22.41 >0.78 2.49 >0.09 

Stone 

fruit 0.14 14 2 38.98 >1.35b 17.87 >0.62 21.93 >0.76 2.44 >0.08 

Grape 0.125 30 2 30.59 >1.06b 14.02 >0.49 17.21 >0.60 1.91 >0.07 

Climbing 0.12 30 2 29.37 >1.02b 13.46 >0.47 16.52 >0.57 1.84 >0.06 

Hops 0.1 14 2 27.85 >0.97 12.76 >0.44 15.66 >0.54 1.74 >0.06 

Cucurbit 0.08 7 2 26.89 >0.93 12.32 >0.43 15.12 >0.53 1.68 >0.06 

a Chronic risk estimates for birds are based upon a non-definitive NOAEC of <28.8 mg/kg-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 

(in bold) have been identified separately from those that are not currently exceeding but have the potential to until a definitive NOAEC is 

established. 

b The chronic RQ meets or exceeds the chronic risk LOC (1) even based on the non-definitive NOAEC of <28.8 mg a.i./kg diet. 

b. Risks to Non-Target Mammals

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 

upper-bound EECs for total residues for the most conservative modeled scenario (Table IV.6); 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 mammals (15g mammals 

foraging on short grass; see “Terrestrial Exposure Assessment”) the RQ value is <0.01, a value an order 

of magnitude below the acute endangered species LOC of 0.1. In addition, the highest acute RQ of <0.03 

for mammals, one that was based on a highly conservative estimate of dietary toxicity, is less than onethird 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. 
Page 164 of 216 

Although there were parental systemic, reproductive, and offspring effects at the LOAEC of 6000 mg/kgdiet in the available 2-generation rat reproduction study, based upon the NOAEC of 1000 mg/kg-diet 

(NOAEL = 70.7 mg/kg bw/day), 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 (1), the chronic RQs for all of the other 

scenarios are also below the Agency’s LOCs and are not presented here. 

Table IV.6. Dose- and dietary-based acute and chronic RQs for mammals exposed to spirotetramat based on 

upper-bound total residues on short grass as calculated by T-REX for the maximum exposure scenario.a

Type of 

Analysis 

Size 

Class 

(g) 

Acute LC50 or 

Adjusted Acute 

LD50 b

Chronic NOAEC 

or Adjusted 

Chronic NOAEL b

Food Item 

Short Grass 

EEC b Acute 

RQ d, e Chronic RQ f 

Dose-based 

15 >4396 mg/kg-bw 155 mg/kg-bw 49.99 mg/kg-bw <0.01 0.32 

35 >3557 mg/kg-bw 126 mg/kg-bw 34.55 mg/kg-bw <0.01 0.27 

1000 >1538 mg/kg-bw 54 mg/kg-bw 8.01 mg/kg-bw <0.01 0.15 

Dietary-based N/A >2000 mg/kg-diet c 1000 mg/kg-diet 52.44 mg/kg-diet <0.03 0.05 a The maximum exposure scenario was the pome fruit scenario, with a maximum single application rate of 0.14 lb a.i./A, a 7-day application 

interval, and a maximum of 3 applications. 

b 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. 

c A conservative estimate of dietary acute toxicity was generated using the existing rat oral LD50 and assuming a conservative ingestion rate of 100 

percent of the body weight. The resulting estimated dietary acute toxicity endpoint is >2000 mg/kg-diet [(>2000 mg/kg-bw)(1 kg-bw/1kg-diet) = 

>2000 mg/kg-diet]. 

d

The most sensitive LD50 and LC50 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 . 

e

All acute RQs are below the acute LOCs for non listed species (0.5), restricted use (0.2), and listed species (0.1). f All chronic RQs are below the chronic risk LOC (1). 

c. Risks to 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. 

d. Risks to Non-Target Plants Inhabiting Dry (Upland) and SemiAquatic (Wetland) Areas 

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). 

A comparison of the most sensitive measures of effect from the available vegetative vigor and seedling 

emergence studies (summarized in Table III.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 IV.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 
Page 165 of 216 

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. 

Table IV.7. RQs for non-target plants inhabiting dry (upland) and semi-aquatic (wetland) areas based on 

EECs of total spirotetramat (parent + degradates) residues on plants following the maximum exposure 

scenario of all crops using the TerrPlant model (lbs a.i./A).a 

Application 

Method; 

Rate 

Plant 

Type 

Upland Wetland Drift Only 

EEC 

lbai/A 

NonListed 

RQb 

Listed 

RQc 

EEC 

lbai/A 

NonListed 

RQb 

Listed 

RQc 

EEC 

lbai/A 

NonListed 

RQd 

Listed 

RQe 

Aerial Spray 

Application, 

Unincorp.; 

0.16lb a.i./A 

Monocot 

0.016 

<0.1 0.1 

0.088 

<0.55 0.55 

0.008 

0.13 0.40 

Dicot <0.1 0.1 <0.55 0.55 <0.1 <0.1 

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 fraction = 0.05), and that the solubility is greater than 100 mg/L (solubility fraction=0.05). Refer to “Exposure Characterization” section of 

the assessment for additional information. 

b

 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. 

c

 The most sensitive NOAEC value from 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. 

d

 The most sensitive EC25 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. 

e

 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. 

B. Risk Description 

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 spirotetramat–

ketohydroxy), 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.

Spirotetramat is a systemic broad spectrum tetramic 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 spirotetramat, 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 
Page 166 of 216 

concentrate), and PYI 8330 OD (oil dispersion), are proposed for use on crops such as citrus fruits, grapes 

and small fruit climbing, pome fruits, stone fruits, 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. 

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 4.2x10-11 mm Hg (20°C) and Henry’s Law constant 

of 6.90x10-13 Atm-m3

/mol at pH 7 and 20 oC). 

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-enol and spirotetramat-ketohydroxy (the two major transformation products (>10%) in the 

aerobic soil metabolism studies) and mineralization to CO2. 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-enol is then further 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 mg/L at pH 7; KOC= 289 

mL/gOC; KOW=324), spirotetramat-enol (solubility =2,700 mg/L at pH 7; KOC= 55 mL/gOC; KOW=2.1), and 

spirotetramat-ketohydroxy (solubility =228 mg/L at pH 5.7; KOC= 65.3 mL/gOC; KOW=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-enol 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 (DT50<1day), 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 

(DT50≤16.7 days), it was observed in much lower amounts (24.0% of the applied at 1 DAT). 

Once in aquatic environments, important routes of degradation/ transformation for spirotetramat include 

hydrolysis in alkaline media (DT50 = 0.32 days at pH 9), photolysis in natural water (DT50 = 0.74 

Phoenix, AZ days) and biodegradation in anaerobic environments (DT50 ≤2.8 days). In addition, under 

aerobic aquatic conditions, spirotetramat was mostly associated with the aqueous phase and rapidly 

degraded with a calculated DT50 of <1day in the total system. The major transformation products in the 

aerobic aquatic metabolism study, spirotetramat-enol and spirotetramat-ketohydroxy, were much more 

persistent than the parent under the same conditions (DT50 = 37.9-59.0 days for spirotetramat-enol 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 and/or 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, 
Page 167 of 216 

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 from 141-693 days (mean 364 days). These values indicate 

high persistence of the total residues of spirotetramat. 

Although both spirotetramat-enol 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 (EC50=4.49 mg a.i./L; 

LOAEC=6.06 mg a.i./L) and spirotetramat–enol (EC50=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 + spirotetramat-enol + 

spirotetramat-ketohydroxy) generated using the Tier 2 aquatic model PRZM/EXAMS 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 

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 CA, AZ, FL, GA, LA, NC, 

TX, and/or SC, for which there are more than one growing season within a single year. 
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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 definitive acute toxicity endpoint for the water flea 

(LC50>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 (0.0111 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 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 (Chironomus riparius), 

both spirotetramat–enol (EC50=74.9 mg a.i./L; LOAEC=16 mg a.i./L based on 13% mortality) and 

spirotetramat–ketohydroxy (EC50>100 mg a.i./L; LOAEC<1 mg a.i./L based on 5% mortality) are less 
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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 from the study based on initial nominal concentrations in overlying 

water (NOAEC=0.1 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 Kow is ~2.5, its maximum Koc is 437, its 

aerobic soil metabolism half-life is <1day, 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 estuarine/marine invertebrates and fish. Chronic toxicity 

data for estuarine/marine 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 EC50 is <1mg/L and the highest estimated environmental concentration (EEC) in water is 

≥ 0.01 of the acute EC50. However, these toxicity estimates are based on toxicity to the eastern oyster, yet 

the chronic life-cycle study with estuarine/marine 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 estuarine/marine 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 

a. Non-Target Birds and Mammals

Based on the best available information and terrestrial exposure modeling with T-REX, the only concerns 

that the Agency has with respect to risk to terrestrial vertebrates resulting from 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 LD50 values for the parent and 
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degradates are >2000 mg/kg-bw) suggests that both the parent and the major degradates are practically 

non-toxic. A testicular/sperm toxicity study that was conducted with spirotetramat-enol and reviewed by 

the Office of Pesticide Program’s Health Effects Division, revealed toxic effects in rats at 800 mg/kg-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-enol 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 LD50 of >2000 mg/kg-bw was used to generate acute oral risk quotients, the mallard LC50 of >6050 

mg/kg-diet, 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 mg/kg-bw). If this estimate and the average body weight of the birds is used in TREX 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 fruit 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 LD50 of >2000 mg/kg-bw established 

for quail in the only acute oral toxicity study available, suggests that the overall potential for acute 

mortality of birds resulting from 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 mg/kgdiet; 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 

mortality because body weight effects are observed at much lower concentrations of spirotetramat (lowest 

NOAEC <344 mg/kg-diet vs. lowest LC50>5000 mg/kg-diet ), it is unclear how these effects would 

impact the birds’ 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 nondefinitive NOAECof <28.8 mg/kg-diet (adverse reproductive effects were observed at the lowest tested 
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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-defintive 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 >1.50) 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 fruit 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 >0.64 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. (1994) and assuming a log-normal distribution of residues on food items shows that 

the mean Kenaga values range from about the 62-87 percentile indicating that up to 38% of the higherend food item residue estimates are not captured by using the mean Kenaga values. In contrast, for the 

upper-end Kenaga residue estimates, about 3-13% 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 mg/kg-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 definitive NOAEC is established for chronic/reproductive effects to 

birds. 

A closer look at the most sensitive NOAEC value of <28.8 mg/kg-diet (LOAEC = 28.8 mg/kg-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 mg/kg-diet 

(LOAEC = 78.8 mg/kg-diet ) include # of hatchlings of live 3-week embryos (↓20%), # of 14-day old 

survivors of eggs set (↓17%), # of 14-day survivors per hen (↓38%), # eggs laid per hen (↓34%), # of eggs 

set (↓33%), and # of eggs hatched (↓36%). 

While the use of the 28.8 mg/kg-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 mg/kg-diet and whether a request for an 

additional avian reproduction study is warranted based on a 6.58% reduction in hatchling bodyweight at 
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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 (↓22%), # of viable 14-day embryos (↓18%), # of live embryos (↓18%), and # of eggs hatched 

(↓22%). 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 mg/kg-diet treatment level, 

there were effect levels up to 31% for some endpoints that were not detected as being statistically 

significant using either Williams’ or Dunnett’s tests (e.g., ↓31% viable embryo (Day14) and ↓31% live 

embryo (Day21)), and effect levels up to 38% for some endpoints that were not detected as being 

statistically significant using Dunnett’s tests (e.g., ↓38% hatching survival (Day14), ↓36% # hatched, 

↓33% eggs set, and ↓34% 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 from 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 (↓22%) of those endpoints at the lowest test concentration (28.8 mg/kg-diet ) that were not 

determined to be statistically reduced as compared to the control using either Williams’ or Dunnett’s tests. 

The BMD software 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 mg/kg-diet, respectively. The estimated concentrations that 

corresponded to the effect 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 mg/kg-diet ). Previously, based on the NOAEC of 28.8 mg/kg-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). 
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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 fruit) 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 

(↓6-7%) 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 

mg/kg-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. 

Table IV.8. Ranges of theoretical dietary-based avian chronic RQs for the all exposure 

scenarios (for characterization purposes only) based on estimated upper-bound residues and 

estimated 5, 10, and 15% effects levels. a, b

Effect Level 

(% Effect) 

Range of RQs for Birds That Feed on Various Food Items 

Short Grass Tall Grass Broadleaf Plants/ 

Small Insects 

Fruits/Pods/Seeds/ 

Large Insects 

Parent-only residues 

5 2.84 to 5.19 1.30 to 2.38 1.60 to 2.92 0.18 to 0.32 

10 1.43 to 2.61 0.66 to 1.20 0.80 to 1.47 0.09 to 0.16 

15 0.95 to 1.74 0.44 to 0.80 0.54 to 0.98 0.06 to 0.11 

Total residues 

5 3.24 to 6.32 1.48 to 2.90 1.82 to 3.55 0.20 to 0.39 

10 1.63 to 3.18 0.75 to 1.46 0.92 to 1.79 0.10 to 0.20 

15 1.08 to 2.11 0.50 to 0.97 0.61 to 1.19 0.07 to 0.13 a Upper-bound residues calculated using T-REX model (T-REX, Version 1.3.1, dated December 7, 2006). b 5, 10, and 15% effect levels correspond to concentrations of 8.3, 16.5, and 24.8 mg/kg-diet , as estimated using The 

Benchmark Dose Approach (BMD; US EPA, 2006).

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 
Page 174 of 216 

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 labelrecommended 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 fruits 

dropped from >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 from >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.

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 in/on plants based on the magnitude of 

residue studies, the short residence time of the parent and spirotetramat-enol 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. 
Page 175 of 216 

 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. 

Honey 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 LD50 values established as >107.3 μg a.i./bee and >100 μg 

a.i./bee, respectively. In addition, according to other acute toxicity studies, a spirotetramat formulation 

(Spirotetramat OD 150) is also classified as practically non-toxic to bees with acute oral and contact LD50

values established as 91.7 μg a.i./bee and 162.0 μg 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 BYI08330 100 OD and BYI08330 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 (BYI08330 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 BYI08330 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 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 prepared, 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 tents/tunnels 

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. 
Page 176 of 216 

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 Arthropods

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. 

Formulated spirotetramat (Spirotetramat 150 OD) had a wide range in magnitude of acute effects on 

various non-target arthropods, from an LD50 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 LD50 = 0.0003 lb a.i/A for a 7-day acute contact toxicity test with predatory 

mite protonymphs (Typhlodromus pyri) 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 (LD50=0.10 lb a.i./A), a 7-day acute study with predatory 

mite protonymphs (Typhlodromus pyri) exposed to dried residues on treated bean leaves (LD50=0.0014 lb 

a.i./A; ↓ reproduction NOAEC < 0.0001 lb a.i./A), a study with green lacewing larvae (Chrysoperia 

carnea) exposed to dried residues on treated bean leaves until pupation (LD50 > 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 (LD50 > 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 (>51%), indicating a 

lingering effect post application. 
Page 177 of 216 

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 fungivorous mites. Based 

on the results, it was concluded that BYI08330 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-Dwelling 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 (EC50/LC50 and NOAEC values were >1000 

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

125 mg/kg-dry weight soil based on body weight effects. Lastly, in an 8-week study with spirotetramatenol, a NOAEC of 32 mg/kg-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 316 and 

>1000 mg/kg-dry weight soil, respectively, while the LC50/EC50 for both was >1000 mg/kg-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

 / (1.3g/cm3 *1cm * 0.001kg/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 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), 
Page 178 of 216 

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 nonlisted 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 

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 
Page 179 of 216 

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 fry 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 

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 action 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 downwind 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 
Page 180 of 216 

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.
181

Table V.1. Potential Direct and Indirect Effects to Listed Species 

Listed 

Taxonomic 

Group 

Is there 

Potential for 

Direct 

Effects? 

Basis for Direct 

Effects Potential 

Is there Potential 

for Indirect Effects 

Based on Direct 

Effects LOCs?

Taxonomic Groups Potentially 

Directly Affected that Could 

Result in Indirect Effects 

Terrestrial and 

semi-aquatic plants 

– monocots and 

dicots 

No No LOCs were 

exceeded Yes Terrestrial invertebrates, birds 

Terrestrial 

invertebrates Yes 

Toxic effects 

observed in 

available studies at 

less than the 

proposed maximum 

application rate 

Yes Birds, terrestrial amphibians, and 

reptiles 

Birds, terrestrial 

amphibians, and 

reptiles1

Yes Chronic LOCs were 

exceeded Yes Terrestrial invertebrates 

Mammals No No LOCs were 

exceeded Yes Terrestrial invertebrates 

 Aquatic plants 

(vascular and nonvascular) No No LOCs were 

exceeded Yes Terrestrial invertebrates 

Fish, aquatic 

amphibians2 No No LOCs were 

exceeded Yes Terrestrial invertebrates, birds, 

terrestrial amphibians, and reptiles 

Aquatic 

Invertebrates No No LOCs were 

exceeded Yes Birds, terrestrial amphibians, and reptiles 1 Birds are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, 

reptilian, and amphibian species are considered equivalent. 

2 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.

 2. Probit Dose Response Relationship 

 

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 estuarine/marine invertebrates was from a study 

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

mortality/immobilization data available for mysids was used to perform these analyses for 

estuarine/marine 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 based on the mean, upper and lower estimates of the effects probability are also provided to 
182

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 IECV1.1 (Individual 

Effect Chance Model Version 1.1) 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 = logLC50+(z/b), where z is the standard normal deviate and b equals the 

slope. 

If an LD50 or LC50 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 LC50 or LD50 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 1039, respectively. 

Estuarine/Marine 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 estuarine/marine 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 105

 and ~1 in 2.26 x 

1024, respectively. 

Freshwater Invertebrates (Dorgerloh, 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 1017. 

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 1010 and ~1 in 1.80 x 

1028, respectively. 
183

Estuarine/Marine Invertebrates (Based on Mysid data; Cafarelle, 2005a)

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 estuarine/marine invertebrates is ~1 in 1.45 x 104

. 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 1010, 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 (LC50 or LD50). It was demonstrated that the LC50 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 

105

. 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 1018, 

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 LD50 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 LD50 values. 

Table V.2. A summary of the probit slope analyses performed for spirotetramat. 

Taxonomic Group Slope (95% CI) Probability of Individual Effect at LOC 

Freshwater fish 5.61 (0.99, 10.22) ~1 in 6.25 x 1012 

 (~1 in 10.1 and ~1 in 8.25 x 1039) 

Estuarine/marine fish 5.70 (3.50, 7.70) ~1 in 1.66 x 1013 

(~1 in 3.79 x 105 and ~1 in 2.26 x 1024)

Freshwater invertebrates 6.73 (4.92, 8.54) ~1 in 9.88 x 1017

(~1 in 1.30 x 1010 and ~1 in 1.80 x 1028)

Estuarine/marine invertebrates 2.93 (0.79, 5.06) ~1 in 1.45 x 104

(~1 in 6.58 and ~1 in 4.34 x 1010)

Birds 4.5 (2, 9) ~1 in 2.94 x 105
184

(~1 in 44 and ~1 in 8.86 x 1018)

Mammals None available Not calculated; no mortality observed 

 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. 

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). 

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 insects/terrestrial 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 
185

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 insects/terrestrial 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 

endangered/threatened 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 spirotetramat 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 endangered/threatened 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 FIFRA 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
186

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Annex II Data and Information 

KIIA 7.1.1 /01/ 

MRID 46904408 

Babczinski, P. 2006a Aerobic degradation/metabolism of BYI8330 in four 

different soils 

Bayer CropScience AG, 

Report No.: MEF-04/169, 

Edition Number: M-256849-02-2 

Date: 07.07.2005, Amended: 05.05.2006 

GLP, unpublished 

 also filed: KIIA 7.2.1 /01 

Yes BCS 

KIIA 7.1.1 /02/ 

MRID 46904409 

Babczinski, P. 2006b Outdoor metabolism of [azaspirodecenyl-3-

14C]BYI08330 in two soils 

Bayer CropScience AG, 

Report No.: MEF-06/041, 

Edition Number: M-270597-01-2 

Date: 03.04.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.1.1 /03/ 

MRID 46904428 

Babczinski, P. 2006c [Azaspirodecenyl-3-14C]- and [azaspirodecenyl-5-14C]-

labelled BYI08330-cis-enol: Comparative aerobic soil 

metabolism/degradation in four soils 

Bayer CropScience AG, 

Report No.: MEF-05/157, 

Edition Number: M-269304-01-2 

Date: 17.01.2006 

GLP, unpublished 

 also filed: KIIA 7.2.3 /01 

Yes BCS 

KIIA 7.1.2 /01/ 

MRID 46904410 

Menke, U. 2006 BYI08330: Anaerobic soil metabolism 

Bayer CropScience AG, 

Report No.: MEF-05/515, 

Edition Number: M-270739-01-2 

Date: 03.05.2006 

GLP, unpublished 

 also filed: KIIA 7.2.4 /01 

Yes BCS 

KIIA 7.1.3 /01/ 

MRID 46904503 

Heinemann, O. 2005 [Azaspirodecenyl-3-14C]- and [azaspirodecenyl-5-

14C]BYI08330: Phototransformation on soil 

Bayer CropScience AG, 

Report No.: MEF-04/481, 

Edition Number: M-252907-01-2 

Date: 25.04.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.2.1 /01 Babczinski, P. 2006a Aerobic degradation/metabolism of BYI8330 in four 

different soils 

Bayer CropScience AG, 

Report No.: MEF-04/169, 

Edition Number: M-256849-02-2 

Date: 07.07.2005, Amended: 05.05.2006 

GLP, unpublished 

 also filed: KIIA 7.1.1 /01 

Yes BCS 

KIIA 7.2.1 /02/ No 

MRID 

Ramanarayanan, 

T.; Roepke, B. 

2006 Degradation of BYI08330 in four soils under aerobic 

conditions: kinetic evaluation 

Bayer CropScience AG, 

Report No.: MEF-05/249, 

Edition Number: M-277096-01-2 

Date: 30.08.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 7.2.3 /01 Babczinski, P. 2006c [Azaspirodecenyl-3-14C]- and [azaspirodecenyl-5-14C]-

labelled BYI08330-cis-enol: Comparative aerobic soil 

metabolism/degradation in four soils 

Yes BCS 
187

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Bayer CropScience AG, 

Report No.: MEF-05/157, 

Edition Number: M-269304-01-2 

Date: 17.01.2006 

GLP, unpublished 

 also filed: KIIA 7.1.1 /03 

KIIA 7.2.3 /02/ No 

MRID 

Roepke, B. 2007 Kinetic evaluation of laboratory soil degradation studies 

of BYI08330-Enol, BYI08330-ketohydroxy, BYI08330-

MA-amide 

Bayer CropScience AG, 

Report No.: MEF-06/199, 

Edition Number: M-277178-01-2 

Date: 31.05.2007 

Non GLP, unpublished 

Yes BCS 

KIIA 7.2.3 /03/ 

MRID 46904420 

Dehner, D.; 

Heinemann, O. 

2006 [Carbonyl-14C] 4-methoxycyclohexanone: Aerobic soil 

degradation in three soils 

Bayer CropScience AG, 

Report No.: MEF-05/485, 

Edition Number: M-269022-02-2 

Date: 28.02.2006, Amended: 18.07.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.2.4 /01 Menke, U. 2006a BYI08330: Anaerobic soil metabolism 

Bayer CropScience AG, 

Report No.: MEF-05/515, 

Edition Number: M-270739-01-2 

Date: 03.05.2006 

GLP, unpublished 

 also filed: KIIA 7.1.2 /01 

Yes BCS 

KIIA 7.3.1 /01/ 

MRID 46904414 

Netzband, D. J. 2006a In house laboratory validation of an analytical method for 

the determination of BYI08330 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, 

Edition Number: M-277365-01-1 

Method Report No US: RAFNX012 

Date: 29.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.3.1 /02/ 

MRID 46904424 

Lenz, Mark 2006a Terrestrial field dissipation of BYI08330 in New York 

soil, 2004 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MEFNY004, 

Edition Number: M-277191-01-1 

Date: 05.09.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.3.1 /03/ 

MRID 46904421 

Lenz, Mark 2006b Terrestrial field dissipation of BYI08330 in Florida soil, 

2004 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MEFNX055, 

Edition Number: M-277184-01-1 

Date: 05.09.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.3.1 /04/ 

MRID 46904422 

Lenz, Mark 2006c Terrestrial field dissipation of BYI08330 in California 

soil, 2004 

Bayer CropScience, Stilwell, KS, USA 

Yes BCS 
188

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Bayer CropScience AG, 

Report No.: MEFNY002, 

Edition Number: M-277186-01-1 

Date: 05.09.2006 

GLP, unpublished 

KIIA 7.3.1 /05/ 

MRID 46904423 

Lenz, Mark 2006d 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 

Yes BCS 

KIIA 7.3.1 /06/ 

MRID 46904417 

Netzband, D. J. 2006b Stability of AE 0317309 and AE B197555 in soil during 

frozen storage, USA, 2005 (reported through a maximum 

of 320 days storage) 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNX018, 

Edition Number: M-277371-01-1 

Date: 29.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.3.1 /07/ Brumhard, B. 2006 Independent laboratory validation of method FN-002-S05-

02 for the determination of BYI08330 and its metabolites 

BYI08330-enol, BYI08330-keto-hydroxy and BYI08330-

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

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: MR-06/037, 

Edition Number: M-276038-01-2 

Date: 14.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.3.1 /08 Röpke, B.; 

Ramanarayanan, 

T. 

2007 Environmental behaviour of spirotetramat and its 

metabolites in U.S. field dissipation trials 

Report No.; MEF-07/120 

Edition Number: - 

Date: 31.05.2007 

GLP, unpublished 

Yes BCS 

KIIA 7.4.1 /01/ 

MRID 46904413 

Haas, M. 2005 BYI08330: Adsorption/desorption in five soils 

Bayer CropScience AG, 

Report No.: MEF-04/373, 

Edition Number: M-266755-01-2 

Date: 21.10.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.4.2 /01/ 

MRID 46904429 

Hein, W. 2005a Adsorption/desorption of BYI08330-cis-enol 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 

Yes BCS 

KIIA 7.4.2 /02/ 

MRID 46904430 

Menke, U. 2006b [Azaspirodecenyl-3-14C]BYI08330-enol: Timedependent sorption in soils 

Bayer CropScience AG, 

Report No.: MEF-05/222, 

Edition Number: M-268122-01-2 

Date: 25.01.2006 

Yes BCS 
189

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

GLP, unpublished 

KIIA 7.4.2 /03/ 

MRID 46904425 

Hein, W. 2005b 14C-BYI08330-ketohydroxy: Adsorption/desorption in 

five soils 

Rheinland-Pfalz AgroScience GmbH, Neustadt, Germany 

Bayer CropScience AG, 

Report No.: IM2001, 

Edition Number: M-267955-02-2 

Date: 09.09.2005, Amended: 30.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.4.2 /04/ 

MRID 46904432 

Simmonds, M.; 

Early, E. 

2005 [14C]-BYI08330-MA-amide: Adsorption to and 

desorption from five soils 

Battelle UK Ltd.; Ongar; United Kingdom 

Bayer CropScience AG, 

Report No.: CX/04/070, 

Edition Number: M-263686-01-2 

Date: 07.09.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.4.2 /05/ 

MRID 46904433 

Neumann, B.; 

Klempner, A. 

2006 Estimation of the adsorption coefficient (Koc) of BYI 

08330-enol dimer 1 (ROI 6, 14C-labelled) and BYI 

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

high performance liquid chromatography (HPLC) 

Bayer CropScience AG, 

Report No.: MEF-06/123, 

Edition Number: M-274184-01-2 

Date: 19.05.2006, Amended: 01.06:2007 

GLP, unpublished 

Yes BCS 

KIIA 7.4.4 /01/ 

MRID 46904431 

Babczinski, P. 2006d 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 

Yes BCS 

KIIA 7.4.4 /02 Hammel, K. 2007 Analysis of the sorption behaviour of BYI08330-Enol 

using a column leaching experiment 

Bayer CropScience AG, 

Report No.: MEF-07/220 

Edition number: -, 

Date: 04.06.2007, 

Non GLP, unpublished 

Yes BCS 

KIIA 7.4.9 /01/ No 

MRID 

Franke, J. 2004 BYI 08330, Mix-Batch 08045/0003 - Vapour pressure 

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

Germany 

Bayer CropScience AG, 

Report No.: 20040156.02, 

Edition Number: M-066171-01-1 

Date: 26.04.2004 

GLP, unpublished 

 also filed: KIIA 2.3.1 /01 

Yes BCS 

KIIA 7.4.9 /02/ No 

MRID 

Bogdoll, B. 2005 Henry's law constant of BYI 08330(AE 1302943) at pH 7 

and pH 9 

Bayer CropScience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: AF05/085, 

Edition Number: M-262215-01-1 

Date: 08.12.2005 

Non GLP, unpublished 

 also filed: KIIA 2.3.2 /01 

Yes BCS 

KIIA 7.5 /01/ 

MRID 46904405 

Heinemann, O. 2004a [Azaspirodecenyl-3-14C]- and [azaspirodecenyl-5-

14C]BYI08330: Hydrolytic degradation 

Yes BCS 
190

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Bayer CropScience AG, 

Report No.: MEF-04/176, 

Edition Number: M-093124-01-2 

Date: 08.09.2004 

GLP, unpublished 

 also filed: KIIA 2.9.1 /01 

KIIA 7.5 /02/ 

MRID 46904426 

Heinemann, O. 2004b [Azaspirodecenyl-3-14C]- and [azaspirodecenyl-5-

14C]BYI08330-enol: Hydrolytic degradation 

Bayer CropScience AG, 

Report No.: MEF-04/311, 

Edition Number: M-242999-01-2 

Date: 03.12.2004 

GLP, unpublished 

Yes BCS 

KIIA 7.6 /01/ 

MRID 46904406 

Stupp, H. - P. 2005a BYI08330: Phototransformation of BYI08330 in sterile 

water 

Bayer CropScience AG, 

Report No.: MEF-05/206, 

Edition Number: M-266695-01-2 

Date: 15.11.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.6 /02/ No 

MRID 

Stupp, H. - P. 2005b [Azaspirodecenyl-3-14C]BYI08330 and 

[Azaspirodecenyl-5-14C]BYI08330: Phototransformation 

in natural water 

Bayer CropScience AG, 

Report No.: MEF-05/262, 

Edition Number: M-266753-01-2 

Date: 15.11.2005 

GLP, unpublished 

 also filed: KIIA 2.9.4 /02 

Yes BCS 

KIIA 7.6 /03/ 

MRID 46904407 

Heinemann, O. 2004 BYI08330: Determination of the quantum yield and 

assessment of the environmental half-life of the direct 

photodegradation in water 

Bayer CropScience AG, 

Report No.: MEF-04/080, 

Edition Number: M-092941-01-2 

Date: 28.09.2004 

GLP, unpublished 

 also filed: KIIA 2.9.3 /01 

 also filed: KIIA 2.9.4 /01 

Yes BCS 

KIIA 7.6 /04/ 

MRID 46904427 

Heinemann, O. 2005c BYI08330-enol: Determination of the quantum yield and 

assessment of the environmental half-life of the direct 

photodegradation in water 

Bayer CropScience AG, 

Report No.: MEF-04/438, 

Edition Number: M-243787-01-2 

Date: 10.01.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.7 /01/ No 

MRID 

Weyers, A. 2005 BYI 08330 - Biodegradation 

Bayer Industry Services, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: 2005/0077/01, 

Edition Number: M-263287-01-1 

Date: 16.11.2005 

GLP, unpublished 

Yes BIS 

KIIA 7.8.3 /01/ 

MRID 46904412 

Menke, U. 2006 BYI08330: Aerobic aquatic metabolism 

Bayer CropScience AG, 

Report No.: MEF-04/511, 

Edition Number: M-269307-01-2 

Yes BCS 
191

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Date: 29.03.2006 

GLP, unpublished 

KIIA 7.8.3 /02/ No 

MRID 

Roepke, B. 2006 Kinetic evaluation of the aerobic aquatic metabolism of 

BYI08330, BYI08330-enol and BYI08330-ketohydroxy 

in water sediment systems 

Bayer CropScience AG, 

Report No.: MEF-06/279, 

Edition Number: M-277415-01-1 

Date: 30.08.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 7.8.3 /03/ 

MRID 46904411 

Shepherd, J.; 

Arthur, E. L.; 

Dominic, A. 

2005 BYI08330[azaspirodecenyl-3-14C]: Anaerobic aquatic 

metabolism 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

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

Edition Number: M-261943-01-1 

Date: 06.12.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.10 /01/ No 

MRID 

Hellpointner, E. 2004a Calculation of the chemical lifetime of BYI 08330 in the 

troposphere 

Bayer CropScience AG, 

Report No.: MEF-04/400, 

Edition Number: M-092840-01-1 

Date: 14.09.2004 

Non GLP, unpublished 

 also filed: KIIA 2.10 /01 

Yes BCS 

KIIA 7.10 /02/ No 

MRID 

Hellpointner, E. 2004b Calculation of the chemical lifetime of BYI 08330-enol in 

the troposphere 

Bayer CropScience AG, 

Report No.: MEF-04/401, 

Edition Number: M-092841-01-1 

Date: 21.09.2004 

Non GLP, unpublished 

Yes BCS 

KIIA 7.13 /01 Hellpointner, E. 2007 Position Paper: Spirotetramat (BYI08330) – Fate and 

Behaviour 

Bayer CropScience Deutschland GmbH, Frankfurt am 

Main, Germany 

Bayer CropScience AG, 

Report No.: MEF-07/299, 

Edition Number: - 

Date: 06.07.2007 

GLP, unpublished 

Yes BCS 

KIIA 7.13 /02/ No 

MRID 

Eyrich, U.; 

Bogdoll, B. 

2006 Water solubility of BYI 08330-enol (AE 1302944) at pH 

5, pH 7 and pH 8 (Flask Method) 

Bayer CropScience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: PA06/035, 

Edition Number: M-275829-01-2 

Date: 11.08.2006 

GLP, unpublished 

Yes BCS 

KIIA 7.13 /03/ No 

MRID 

Bogdoll, B.; 

Eyrich, U. 

2006 Partition coefficients 1-Octanol / water of BYI 08330-enol 

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

method) 

Bayer CropScience Deutschland GmbH, Frankfurt am 

Main, Germany 

Bayer CropScience AG, 

Report No.: PA06/036, 

Edition Number: M-276091-01-2 

Yes BCS 
192

Annex point/ 

reference number Author(s) Year 

Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data 

Protection 

Claimed 

Y/N 

Owner 

Date: 17.08.2006 

GLP, unpublished 

KIIA 7.13 /04/ No 

MRID 

Bogdoll, B.; 

Lemke, G.; 

Kaussmann, M. 

2006 BYI 08330-enol (AE 1302944) - Determination of the 

dissociation constant (spectrophotometric screening 

method) 

Bayer CropScience GmbH, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: AF06/031, 

Edition Number: M-274084-01-2 

Date: 05.07.2006 

Non GLP, unpublished 

Yes BCS 

KIIA 7.13 /05/ No 

MRID 

Bogdoll, B.; 

Lemke, G. 

2005a Water solubility of BYI 08330-cis-ketohydroxy in 

distilled water (flask method) 

Siemens AG, Frankfurt am Main, Germany 

Bayer CropScience AG, 

Report No.: PA05/099, 

Edition Number: M-268425-01-2 

Date: 06.09.2005 

GLP, unpublished 

Yes BCS 

KIIA 7.13 /06/ No 

MRID 

Bogdoll, B.; 

Lemke, G. 

2005b BYI 08330-cis-ketohydroxy partition coefficient 1-

Octanol/water (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 

Yes BCS 

KIIA 7.13 /07/ No 

MRID 

Bogdoll, B.; 

Lemke, G.; 

Kaussmann, M. 

2005 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.: AF05/098, 

Edition Number: M-263603-01-2 

Date: 16.12.2005 

Non GLP, unpublished 

Yes BCS 

Ecological Effects Studies Discussed in this Assessment Organized According to Annex 

Point/Reference Number

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

Annex II Data and Information 

IIA 8.1.1 Barfknecht, R. 2003 Acute oral toxicity for bobwhite quail (Colinus 

virginianus) for the test item BYI 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 

Yes BCS 
193

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.1.2 Barfknecht, R. 2004 BYI 08330 techn. a.s.: 5-day-dietary LC50 bobwhite 

quail (Colinus virginianus) 

Bayer CropScience AG, 

Report No.: BAR/LC017, 

Edition Number: M-084796-01-2 

Date: 18.08.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.1.3 Stoughton, T. L. 2006 Technical BYI 08330: A subacute dietary LC50 with 

mallards 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX012, 

Edition Number: M-274385-01-1 

Date: 03.05.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.1.4 Sabbert, T. J.; 

Nuessle, C. 

2006a Effect of technical BYI 08330 on northern bobwhite 

reproduction 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNO220, 

Edition Number: M-277757-01-1 

Date: 21.09.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.1.4 Sabbert, T. J.; 

Nuessle, C. 

2006b Effect of technical BYI 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 

Yes BCS 

IIA 8.1.4 Stafford, J. M. 2007a Long-Term Mallard Duck Dermal Exposure to BYI 

08330 

Bayer CropScience AG, 

Report No.: EBFNP033 

Edition Number: M-290165-01-1 

Date: 05.07.2007 

GLP 

unpublished 

Yes BCS 

IIA 8.1.4 Stafford, J. M. 2007b 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-290000-01-1 

Date: 26.06.2007 

GLP 

unpublished 

Yes BCS 
194

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.1.4 /03 Temple, D.L; 

Martin, K.H.; 

Beavers, J.B.; Jaber, 

M. 

2006 BYI 08330 technical: A reproduction study with the 

mallard 

Wildlife International Ltd., Easton, MD, USA 

Bayer CropScience AG, 

Report No.: EBFNP024, 

Edition Number: M-278058-01-1 

Date: 29.09.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.2.1.1 Dorgerloh, M. 2004a Acute toxicity of BYI 08330 (tech.) to fish 

(Oncorhynchus mykiss) 

Bayer CropScience AG, 

Report No.: DOM 24025, 

Edition Number: M-182649-01-2 

Date: 16.12.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.2.1.2 Dorgerloh, M. 2004b Acute toxicity of BYI 08330 (tech.) to fish (Cyprinus 

carpio) 

Bayer CropScience AG, 

Report No.: DOM24022, 

Edition Number: M-128667-01-2 

Date: 25.11.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.2.1.2 Dorgerloh, M. 2005a Acute toxicity of BYI 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 

Yes BCS 

IIA 8.2.1.3 Nieden, D. 2005a Acute toxicity of BYI 08330-enol to fish 

(Oncorhynchus mykiss) 

Bayer CropScience AG, 

Report No.: EBFNM013, 

Edition Number: M-251850-01-2 

Date: 18.05.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.2.1.3 Neuhahn, A. 2006a 4-Methoxycyclohexanone - Acute fish toxicity 

Bayer Industry Services, Leverkusen 

Bayer CropScience AG, 

Report No.: 2006/0032/02, 

Edition Number: M-274305-01-1 

Date: 10.07.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.2.4 Dorgerloh, M. 2005b Early-life stage toxicity of BYI 08330 tech. to fish 

(Pimephales promelas) 

Bayer CropScience AG, 

Report No.: EBFN0305, 

Edition Number: M-260676-01-2 

Date: 16.11.2005 

GLP 

unpublished 

Yes BCS 
195

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.3.1.1 Dorgerloh, M. 2005c 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 

Yes BCS 

IIA 8.3.1.1 Dorgeloh, M. 2005d Acute toxicity of BYI 08330-enol 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 

Yes BCS 

IIA 8.3.1.1 Neuhahn, A. 2006b 4-Methoxycyclohexanone - Acute daphnia toxicity 

Bayer Industry Services, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: 2006/0032/01, 

Edition Number: M-274275-01-1 

Date: 10.07.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.3.2.1 Dorgerloh, M. 2005e Influence of BYI 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-251843-01-2 

Date: 13.05.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.4 Dorgerloh, M. 2004c Pseudokirchneriella subcapitata - Growth inhibition 

test with BYI 08330 (tech.) 

Bayer CropScience AG, 

Report No.: DOM 23092, 

Edition Number: M-128874-01-2 

Date: 29.11.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.4 Kern, M.E.; Lam, 

C.V. 

2005 Toxicity of BYI 08330 to the freshwater diatom 

Navicula pelliculosa

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX008, 

Edition Number: M-252794-01-1 

Date: 15.06.2005 

Non GLP 

unpublished 

Yes BCS 
196

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.4 Kern, M. E.; Lam, 

C. V. 

2006 Toxicity of BYI 08330 to the blue-green alga 

Anabaena flos-aquae

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX007, 

Edition Number: M-264055-01-1 

Date: 12.01.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.4 Dorgerloh, M. 2005f Pseudokirchneriella subcapitata - Growth inhibition 

test with BYI 08330-enol 

Bayer CropScience AG, 

Report No.: EBFNM010, 

Edition Number: M-252531-01-2 

Date: 06.06.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.4 Weyers, A. 2006 4-Methoxycyclohexanone - Alga growth inhibition 

test 

Bayer Industry Services, Leverkusen, Germany 

Bayer CropScience AG, 

Report No.: 2006/0032/03, 

Edition Number: M-275954-01-1 

Date: 28.07.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.5.1 Dorgerloh, M. 2005g Acute toxicity of BYI 08330 (tech.) to larvae of 

Chironomus riparius in a 48 h water-only study 

Bayer CropScience AG, 

Report No.: EBFNX072, 

Edition Number: M-262632-01-2 

Date: 08.12.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.5.1 Dorgerloh, M. 2005h Acute toxicity of BYI 08330-enol to larvae of 

Chironomus riparius 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 

Yes BCS 

IIA 8.5.1 Dorgerloh, M. 2006a Acute toxicity of BYI 08330-ketohydroxy to larvae of 

Chironomus riparius in a 48 h static laboratory test 

system 

Bayer CropScience AG, 

Report No.: EBFNO347, 

Edition Number: M-263956-01-2 

Date: 16.01.2006 

GLP 

unpublished 

Yes BCS 
197

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.5.1 Dorgerloh, M. 2007a 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 

Yes BCS 

IIA 8.5.1 Dorgerloh, M. 2007b 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 

Yes BCS 

IIA 8.5.2 Dorgerloh, M. 2005i Chironomus riparius 28-day 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 

Yes BCS 

IIA 8.6 Dorgerloh, M. 2005j Lemna gibba G3 - Growth inhibition test with BYI 

08330 (tech.) under static-renewal test conditions 

Bayer CropScience AG, 

Report No.: DOM 24019, 

Edition Number: M-255296-01-2 

Date: 29.07.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.6 Dorgerloh, M. 2005k Lemna gibba G3: Growth inhibition test with BYI 

08330-enol under static conditions 

Bayer CropScience AG, 

Report No.: EBFNX065, 

Edition Number: M-252412-01-2 

Date: 07.06.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.7.1 Schmitzer, S. 2004 Effects of BYI 08330 (acute contact and oral) on 

honey bees (Apis mellifera L.) in the laboratory 

Ibcaon GmbH, Rossdorf, Germany 

Bayer CropScience AG, 

Report No.: 20091035, 

Edition Number: M-081227-01-2 

Date: 12.07.2004 

GLP 

unpublished 

Yes BCS 
198

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.7.4 Schur, A. 2004a Assessment of the side-effects of BYI 08330 OD 100 

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

GAB Biotechnologie GmbH & IFU Umweltanalytik 

GmbH, Niefern-Oeschelbronn, Germany 

Bayer CropScience AG, 

Report No.: 20031168/01-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 

Yes BCS 

IIA 8.7.4 Schur, A. 2004b Assessment of the side-effects of BYI 08330 SC 240 

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

GAB GmbH, Niefern-Oeschelbronn, Germany 

Bayer CropScience AG, 

Report No.: 20031166/01-BFEU, 

Edition Number: M-121877-01-2 

Date: 05.02.2004 

GLP 

unpublished 

 also filed: IIIA3 10.4.2.1 

Yes BCS 

IIA 8.8.1.1 Waltersdorfer, A. 2005a Toxicity to the parasitoid wasp Aphidius rhopalosiphi

(DeStephani-Perez) (Hymenoptera: Bracconidae) in 

the laboratory; BYI 08330 150 OD; Code: AE 

1302943 00 OD15 A101 

Bayer CropScience AG, 

Report No.: CW05/023, 

Edition Number: M-254442-01-1 

Date: 15.07.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.8.1.2 Waltersdorfer, A. 2005b Toxicity to the predatory mite Typhlodromus pyri

Scheuten (Acari, Phytoseiidae) in the laboratory, BYI 

08330 150 OD; Code AE 1302943 00 OD15 A101 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/024, 

Edition Number: M-254269-01-1 

Date: 12.07.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.8.2.1 Waltersdorfer, A. 2006a Toxicity to the parasitoid wasp Aphidius rhopalosiphi 

(DeStephani-Perez) (Hymenoptera: Braconidae) 

using an extended laboratory test with BYI 08330 150 

OD 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/071, 

Edition Number: M-264179-01-1 

Date: 18.01.2006 

GLP 

unpublished 

Yes BCS 
199

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.8.2.2 Waltersdorfer, A. 2005c Toxicity to the predatory mite Typhlodromus pyri

SCHEUTEN (Acari, Phytoseiidae) using an extended 

laboratory test BYI 08330 150 OD 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/030, 

Edition Number: M-256306-01-1 

Date: 25.08.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.8.2.4 Roehlig, U. 2005 Dose-response toxicity (LR50) of BYI 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-262650-01-1 

Date: 14.12.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.8.2.4 Waltersdorfer, A. 2006b Toxicity to the ladybird Coccinella septempunctata L. 

(Coleoptera, Coccinellidae) using an extended 

laboratory test including exposure to and oral uptake 

of BYI 08330 150 OD 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/053, 

Edition Number: M-264175-01-1 

Date: 18.01.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.9.1 Lechelt-Kunze, C. 2004a BYI 08830 (techn.): Acute toxicity to earthworms 

(Eisenia fetida) tested in artifical soil with 5 % peat 

Bayer CropScience AG, 

Report No.: LKC/RG-A-18/03, 

Edition Number: M-104105-01-2 

Date: 07.01.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.9.1 Lechelt-Kunze, C. 2005 BYI 08330-cis-ketohydroxy: Acute toxicity to 

earthworms (Eisenia fetida) tested in artificial soil 

Bayer CropScience AG, 

Report No.: LKC/RG-A-47/05, 

Report includes Trial Nos.: Rg08/05 

Edition Number: M-258925-01-2 

Date: 17.10.2005 

GLP, unpublished 

Yes BCS 

IIA 8.9.1 Moser, T.; 

Scheffczyk, A. 

2005 BYI 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-243305-01-2 

Date: 19.01.2005 

GLP, unpublished 

Yes BCS 
200

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.9.1 Leicher, T. 2008 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 

Yes BCS 

IIA 8.10.1 Lechelt-Kunze, C. 2004b BYI 08330 tech.: Determination of effects on 

nitrogen transformation in soil 

Bayer CropScience AG, 

Report No.: LKC-N-32/04, 

Edition Number: M-087831-01-1 

Date: 01.09.2004 

GLP, unpublished 

Yes BCS 

IIA 8.10.1 Lechelt-Kunze, C. 2004c BYI 08330 tech.: Determination of effects on carbon 

transformation in soil 

Bayer CropScience AG, 

Report No.: LKC-C-30/04, 

Edition Number: M-087840-01-1 

Date: 01.09.2004 

GLP, unpublished 

Yes BCS 

IIA 8.11.1 Banman, C. S.; 

Lam, C. V. 

2005 Acute toxicity of BYI 08330 technical to the 

sheepshead minnow (Cyprinodon variegatus) under 

flow-trough conditions 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX006, 

Edition Number: M-255363-01-1 

Date: 27.07.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.11.1 Cafarelle, M. A. 2005a BYI 08330 - Acute toxicity to mysids (Americamysis 

bahia) under flow-through conditions 

Springborn Smithers Laboratories, Wareham, MA, 

USA 

Bayer CropScience AG, 

Report No.: EBFNX010, 

Edition Number: M-270200-01-1 

Date: 06.01.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.11.1 Cafarella, M. A. 2005b BYI 08330 - Acute toxicity to eastern oysters 

(Crassostrea virginica) under flow-through 

conditions 

Springborn Smithers Laboratories, Inc., Wareham, 

MA, USA 

Bayer CropScience AG, 

Report No.: EBFNX011, 

Edition Number: M-257677-01-1 

Date: 15.06.2005 

GLP 

unpublished 

Yes Springborn 
201

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.11.1 Banman, C. S.; 

Lam, C. V. 

2006 Toxicity of BYI 08330 technical to the saltwater 

diatom Skeletonema costatum

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: EBFNX009-1, 

Edition Number: M-271037-02-1 

Date: 23.02.2006, Amended: 16.06.2006 

GLP 

unpublished 

Yes BCS 

IIA 8.12 Gosch, H.; Nguyen, 

D.H. 

2006a Non-target terrestrial plants: an evaluation of the 

effects of BYI 08330 OD 150 in the vegetative vigour 

test (Tier 1) 

Bayer CropScience GmbH, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: VV06/03, 

Edition Number: M-273381-01-1 

Date: 20.06.2006 

Non GLP 

unpublished 

Yes BCS 

IIA 8.12 Christ, M. T.; Lam, 

C. V. 

2006a Tier I and Tier II - Vegetative vigor non-target plant 

study using BYI 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 

Yes BCS 

IIA 8.12 Friedrich, S. 2006 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 

GLP 

unpublished 

Yes BCS 

IIA 8.12 Gosch, H.; Nguyen, 

D.H. 

2006b 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, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: SE06/03, 

Edition Number: M-273373-01-1 

Date: 20.06.2006 

Non GLP 

unpublished 

Yes BCS 

IIA 8.12 Christ, M. T.; Lam, 

C. V. 

2006b 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 

Yes BCS 
202

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIA 8.14 Moser, T.; 

Scheffczyk, A. 

2005 BYI 08330-Enol: Effects on survival and 

reproduction of the predaceous mite Hypoaspis 

aculeifer Canestrini (Acari: Laelapidae) in standard 

soil (LUFA 2.1) 

ECT Oekotoxikologie GmbH, Floersheim, Germany 

Bayer CropScience AG, 

Report No.: P11HR, 

Edition Number: M-243307-01-1 

Date: 19.01.2005 

GLP 

unpublished 

Yes BCS 

IIA 8.15 Bruns; Caspers, N. 2004 BYi 08330 - Toxicity to bacteria 

Bayer Industry Services GmbH, Leverkusen, 

Germany 

Bayer CropScience AG, 

Report No.: 1312 N/04 B, 

Edition Number: M-275364-01-1 

Date: 05.10.2004 

GLP 

unpublished 

Yes BCS 

IIA 8.16 Schneider, K. 2008 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.: RA07-031, 

Edition Number: M-296043-01-1 

Date: 09.01.2008 

GLP, unpublished 

Yes BCS 

Annex III Data and Information 

IIIA1 10.1.2 Wolf, C.; Gerlach, 

J. 

2006 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 

Yes BCS 

IIIA1 10.1.2 Ebeling, M. 

Kyriazi, K. 

2008 Refinement for the risk assessment for the Great Tit 

in citrus orchards following treatment with 

Spirotetramat 

Bayer CropScience AG, 

Edition Number: not yet finalised 

Non GLP, unpublished 

Yes BCS 

IIIA1 10.1.2 Wikens, S., 

Schneider, K. 

2008 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.: RA07-031, 

Edition Number: M-296043-01-2 

Date: 09.01.2008 

GLP, unpublished 

Yes BCS 
203

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIIA1 10.1.7 

MRID 

46904507 

Fischer, D. R., 

Ramanarayanan, T. 

& Ortego, L. 

2006 BYI08330 150 OD - Magnitude of the residue in/on 

soybeans/wheat, potential wildlife feed items 

Bayer CropScience, Stilwell, KS, USA 

Bayer CropScience AG, 

Report No.: RAFNP002, 

Edition Number: M-277315-01-1 

Date: 06.09.2006 

GLP 

unpublished 

Yes BCS 

IIIA1 10.1.7 Wolf, C. 2004 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 

Yes BCS 

IIIA 10.2.2.1 Nieden, D. 2005d Acute toxicity of BYI 08330 OD 150 to fish 

(Oncorhynchus mykiss) under static conditions 

Bayer CropScience GmbH, Monheim, Germany 

Bayer CropScience AG, 

Report No.: EBFNM008, 

Edition Number: M-253916-01-2 

Date: 29.06.2005 

GLP, unpublished 

Yes BCS 

IIIA 10.2.2.2 Dorgerloh, M. 2006d Acute toxicity of BYI 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-264018-01-2 

Date: 19.01.2006 

GLP, unpublished 

Yes BCS 

IIIA 10.2.2.3 Dorgerloh, M. 2006c 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 

Yes BCS 

IIIA1 10.3.1.3 G.D. Cappon, T.L. 

Fleeman, R.E. 

Chapin, and M.E. 

Hurtt 

2005 Effects of feed restriction during organogenesis on 

embryo-fetal development in rabbit 

Publisher:2005 Wiley-Liss, Inc., 

Journal:Birth Defects Research (Part B), 

Volume:74, 

Pages:424-430, 

Year:2005, 

Report No.: Lit. 8639, 

Edition Number: M-274544-01-1 

Non GLP 

published 

No 
204

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIIA1 10.4.2 Barth, M. 2005a Acute toxicity of BYI 08330 150 OD to the honeybee 

Apis mellifera L. under laboratory conditions 

BioChem agrar, Gerichshain, Germany 

Bayer CropScience AG, 

Report No.: 051048032, 

Edition Number: M-259122-01-2 

Date: 18.10.2005 

GLP 

unpublished 

Yes BioChem 

IIIA1 10.4.2.1 Barth, M. 2005b Acute toxicity of BYI 08330 150 OD to the honeybee 

Apis mellifera L. under laboratory conditions 

BioChem agrar, Gerichshain, Germany 

Bayer CropScience AG, 

Report No.: 051048032, 

Edition Number: M-259122-01-2 

Date: 18.10.2005 

GLP 

unpublished 

Yes BioChem 

IIIA1 10.4.2.2 Barth, M. 2005 Acute toxicity of BYI 08330 150 OD to the honeybee 

Apis mellifera L. under laboratory conditions 

BioChem agrar, Gerichshain, Germany 

Bayer CropScience AG, 

Report No.: 051048032, 

Edition Number: M-259122-01-2 

Date: 18.10.2005 

GLP 

unpublished 

Yes BioChem 

IIIA1 10.4.5 Schur, A. 2006 Assessment of side effects of Spirotetramat OD 150 

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

eurofins-GAB GmbH, Niefern-Öschelbronn, 

Germany 

Bayer CropScience AG, 

Report No.: 20061133/S1-BFEU, 

Edition Number: M-277194-02-2 

Date: 11.09.2006 

GLP 

unpublished 

Yes BCS 

IIIA1 10.4.7 Schur, A. 2005 Assessment of side effects of BYI 08330 OD 100 on 

the honey bee (Apis mellifera L.) in the semi-field 

GAB GmbH, Niefern-Oeschelbronn, Germany 

Bayer CropScience AG, 

Report No.: 20041144/01-BZEU, 

Edition Number: M-244490-01-2 

Date: 02.02.2005 

GLP 

unpublished 

Yes BCS 

IIIA1 10.4.7 Koelzer, U. 2007 Summary of orientating research tunnel trials 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-294216-01-1 

Date: 17.10.2007 

Non GLP, unpublished 

Yes BCS 
205

Annex point/ 

reference 

number or 

MRID Number 

Author(s) Year Title 

Source (where different from company) 

Company, Report No 

GLP or GEP status (where relevant) 

Published or not 

Data Protection 

Claimed 

Y/N-R/NR 

Owner 

IIIA1 10.5.2 Waltersdorfer, A. 2006c BYI 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, Frankfurt am Main, 

Germany 

Bayer CropScience AG, 

Report No.: CW05/028, 

Edition Number: M-264153-01-1 

Date: 18.01.2006 

GLP 

unpublished 

Yes BCS 

IIIA1 10.5.4 Aldershof, S.A. 2006 Evaluating effects of BYI 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 

Yes Mitox 

Not included in 

monograph. 

MRID 

47167902 

Gosch, H. 

2007 Spirotetramat SC 240 g/L + (Inert Ingredient): 

Effects on the Vegetative Vigour of the Non-Target 

Terrestial Plant Shattercane (Tier 2). 

Project Number: VV/07/034, EBFNX111, 

M/288612/01/1. 

Unpublished study prepared by Bayer Cropscience 

Gmbh. 

Yes BCS 

Ecological Effects Studies As Organized 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: 

EBFNX012, 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: 149/208, EBFNP024. Unpublished study prepared by Wildlife International, 

Ltd. 162 p. 

MRID: 46904447 
206

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, M/277794/01/2. 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: DOM/24025, E/280/2694/1, M/182649/01/2. Unpublished study prepared by Bayer Ag. 52 p. 

MRID: 46904439 

Dorgerloh, M. (2005) Acute Toxicity of BYI 08330 (tech.) to Fish (Lepomis macrochirus). Project 

Number: DOM/24056, E/280/2747/0, M/242689/01/2. Unpublished study prepared by Bayer Ag. 53 p. 

MRID: 46904460 

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

Conditions. Project Number: EBFNM008, E/280/2935/9. 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: 21371035. Unpublished study prepared by Bayer Cropscience 

Gmbh. 54 p. 

MRID: 46904469 

Dorgerloh, M. (2005) Effects of BYI 08330 240 SC (Acute Contact and Oral) on Honey Bees (Apis 

mellifera L.) in the Laboratory. Project Number: 20031166/01/BFEU, ELECTRONIC/COPY. 

Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 31 p. 

MRID: 46904475 

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

EBFNM013, E/280/2834/7, P/684/037060. Unpublished study prepared by Bayer Ag, Institute of 

Product Info. & Residue Anal. 72 p. 

Guideline: 72-2 Acute Toxicity to Freshwater Invertebrates 

------------------------------------------------------------------------------------- 

MRID: 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/242683/01/2, DOM/24004. Unpublished study prepared 

by Bayer Ag. 44 p. 

MRID: 46904474 

Dorgeloh, M. (2005) Acute Toxicity of BYI 08330-enol to the Waterflea Daphnia magna in a Static 

Laboratory Test System. Project Number: E/320/2812/8, EBFNM012. Unpublished study prepared by 

Bayer Ag, Institute of Product Info. & Residue Anal. 69 p. 
207

Guideline: 72-3 Acute Toxicity to Estuarine/Marine Organisms 

------------------------------------------------------------------------------------- 

MRID: 46904436 

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

Conditions. Project Number: 13798/6170, EBFNX010, M/270200/01/1. 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: 13798/6175, EBFNX011, M/257677/01/1. Unpublished study 

prepared by Springborn Smithers Laboratories. 54 p. 

MRID: 46904440 

Banman, C.; Lam, C. (2005) Acute Toxicity of BYI 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. 

Guideline: 72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study 

------------------------------------------------------------------------------------- 

MRID: 46904441 

Dorgerloh, M. (2005) Influence of BYI 08330 (tech.) on Development and Reproductive Output of the 

Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: EBFN0245, 

E/321/2537/3, M/251843/01/2. 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/260676/01/2. Unpublished study prepared by Bayer Ag. 

96 p. 

Guideline: 122-1 Seed Germination/Seedline 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: EBFNX016. Unpublished study prepared by Bayer Corp. 55 p. 

MRID: 47330401 

Ortego, L.; Nguyen, D.; Christ, M. (2008) Response to AGES/US EPA Request for Additional Analysis 

of Study No. EBFNX016 Tier I and Tier II Vegetative Vigor Non-Target Plant Study Using BYI 08330 

150 OD. Project Number: G201834. Unpublished study prepared by Bayer CropScience LP. 15 p. 

Guideline: 122-2 Aquatic plant growth 

------------------------------------------------------------------------------------- 

MRID: 46904451 
208

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

Project Number: DOM/23092, E/323/2606/2, P604/047065. Unpublished study prepared by Bayer Ag, 

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

Guideline: 123-1 Seed germination/seedling emergence and vegitative vigor 

------------------------------------------------------------------------------------- 

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: EBFNX016. Unpublished study prepared by Bayer Corp. 55 p. 

MRID: 47330401 

Ortego, L.; Nguyen, D.; Christ, M. (2008) Response to AGES/US EPA Request for Additional Analysis 

of Study No. EBFNX016 Tier I and Tier II Vegetative Vigor Non-Target Plant Study Using BYI 08330 

150 OD. Project Number: G201834. 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 BYI 08330 (tech.). 

Project Number: DOM/23092, E/323/2606/2, P604/047065. 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 BYI 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 BYI 08330 Technical to the Saltwater Diatom Skeletonema 

costatum. Project Number: EBFNX009/1. 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 BYI 08330 (tech.) to the Waterflea Daphnia magna Under Static 

Conditions. Project Number: E/320/2536/1, M/242683/01/2, DOM/24004. Unpublished study prepared 

by Bayer Ag. 44 p. 

MRID: 46904474 

Dorgeloh, M. (2005) Acute Toxicity of BYI 08330-enol to the Waterflea Daphnia magna in a Static 

Laboratory Test System. Project Number: E/320/2812/8, EBFNM012. 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 
209

Cafarella, M. (2005) BYI 08330 - Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under FlowThrough Conditions. Project Number: 13798/6175, EBFNX011, 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: 13798/6170, EBFNX010, 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: DOM/24025, E/280/2694/1, M/182649/01/2. Unpublished study prepared by Bayer Ag. 52 p. 

MRID: 46904439 

Dorgerloh, M. (2005) Acute Toxicity of BYI 08330 (tech.) to Fish (Lepomis macrochirus). Project 

Number: DOM/24056, E/280/2747/0, M/242689/01/2. Unpublished study prepared by Bayer Ag. 53 p. 

MRID: 46904440 

Banman, C.; Lam, C. (2005) Acute Toxicity of BYI 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 BYI 08330 OD 150 to Fish (Onchorhynchus mykiss) Under Static 

Conditions. Project Number: EBFNM008, E/280/2935/9. Unpublished study prepared by Bayer Ag, 

Institute of Product Info. & Residue Anal. 51 p. 

MRID: 46904469 

Dorgerloh, M. (2005) Effects of BYI 08330 240 SC (Acute Contact and Oral) on Honey Bees (Apis 

mellifera L.) in the Laboratory. Project Number: 20031166/01/BFEU, ELECTRONIC/COPY. 

Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 31 p. 

MRID: 46904475 

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

EBFNM013, E/280/2834/7, P/684/037060. 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 

Waterflea Daphnia magna in a Static Renewal Laboratory Test System. Project Number: EBFN0245, 

E/321/2537/3, M/251843/01/2. Unpublished study prepared by Bayer Ag. 61 p. 
210

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, E/284/2681/1, M/260676/01/2. Unpublished study prepared by Bayer Ag. 

96 p. 

Guideline: 850.2100 Avian acute oral toxicity test 

------------------------------------------------------------------------------------- 

MRID: 46904444 

Barfknecht, R. (2003) Acute Oral Toxicity for Bobwhite Quail (Colinus virgianus) for the Test Item 

BYI08330 (tech.). Project Number: BAR/LD/47, E/204/2529/4, M/115911/02/2. 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 BYI 08330: A Subacute Dietary LC50 with Mallards. Project Number: 

EBFNX012, M/274385/01/1. 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) BYI 08330 Technical: A Reproduction Study with the 

Mallard. Project Number: 149/208, 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, M/277794/01/2. 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: 20091035, M/081227/01/2. Unpublished study prepared by Institut 

fuer Biologische Analytik und Consulting IBACON. 26 p. 

Guideline: 850.3040 Field testing for pollinators 

------------------------------------------------------------------------------------- 
211

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: 20061133/S1/BFEU. 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: 06/10/48/126. Unpublished study prepared by Biochem Agrar, Lab fuer 

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 240g/L (BYI 08330 SC 240) +0.2% RME EW 500 (AE 0297441 00 1R81 A102) in the 

Vegetative Vigour Test (Tier 1). Project Number: VV06/09, 08330, EBFNX103. Unpublished study 

prepared by Bayer Cropscience Gmbh. 17 p. 

Guideline: 850.4250 Vegetative vigor, Tier II 

------------------------------------------------------------------------------------- 

MRID: 47167902 

Gosch, H. (2007) Spirotetramat SC 240 g/L + (Inert Ingredient): Effects on the Vegetative Vigour of the 

Non-Target Terrestial Plant Shattercane (Tier 2). Project Number: VV/07/034, EBFNX111, 

M/288612/01/1. 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 BYI 08330 (Tech.) Under StaticRenewal Test Conditions. Project Number: DOM/24019, E/412/2676/8. 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-enol Under Static 

Conditions. Project Number: EBFNX065, E/412/2876/0, MR/131/03. Unpublished study prepared by 

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

Guideline: 850.5400 Algal toxicity, Tiers 1 and II 

------------------------------------------------------------------------------------- 

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, E/323/2941/4. Unpublished study prepared by Bayer Ag, Institute of 

Product Info. & Residue Anal. 81 p. 
212

MRID: 46904477 

Dorgerloh, M. (2005) Pseudokirchneriella subcapitata Growth Inhibition Test with BYI 08330-enol. 

Project Number: EBFNM010, 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: 

02/A12/NQ. 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: T/0075503, AT02161. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 24 p. 

MRID: 46904585 

Schungel, M. (2005) BYI 08330 240 SC: Acute Toxicity in the Rat after Oral Administration. Project 

Number: AT02162, T/2075523. 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 BYI 08330. Project Number: 

T1075865. 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 BYI 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 BYI 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: T/2076045, 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: 201426/1. 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: E/310/3411/3, LRT/RG/A/98/07, 

RG/37/07. Unpublished study prepared by Bayer CropScience. 24 p. 

Non-Guideline Study 
213

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MRID: 46904443 

Citation: Dorgerloh, M. (2005) Chironomus riparius 28-Day Chronic Toxicity Test with BYI 08330 

(tech.) in a Water-Sediment System Using Spiked Water. Project Number: EBFN0050, E/416/2813/5, 

M/248099/02/2. Unpublished study prepared by Bayer Ag. 87 p. 

MRID: 46904455 

Citation: Lechelt-Kunze, C. (2004) BYI 08330 (tech.): Acute Toxicity to Earthworms (Eisenia fetida) 

Tested in Artificial Soil with 5% Peat. Project Number: E/310/2552/8, LKC/RG/A/18/03. 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, E/322/2927/7, B684/037060. 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: 20031168/01/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: 20041144/01/BZEU. Unpublished study 

prepared by GAB Biotechnologie Gmbh. 117 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: 05/10/48/032. Unpublished study prepared 

by Biochem Agrar, Lab fuer Biologische und Chemische. 30 p. 

MRID: 46904466 

Citation: Dorgerloh, M. (2006) Acute Toxicity of BYI 08330 OD 150 to Larvae of Chironomus riparius 

in a 48 h Static Laboratory Test System. Project Number: E/322/2936/7, 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 BYI 08330 SC 240 on the Honey Bee (Apis 

mellifera L.) in a Feeding Test. Project Number: 200031166/01/BFEU. Unpublished study prepared by 

Arbeitsgemeinschaft GAB Biotechnologie. 88 p. 

MRID: 46904471 

Citation: Dorgerloh, M. (2006) Pseudokirchneriella subcapitata Growth Inhibition Test with BYI 08330 

SC 240 & RME. Project Number: EBFN0290, E/323/2882/2, MR/131/03. Unpublished study prepared 

by Bayer Ag, Institute of Product Info. & Residue Anal. 92 p. 

MRID: 46904472 

Citation: Lechelt-Kunze, C. (2005) BYI 08330-cis-ketohydroxy: Acute Toxicity to Earthworms (Eisenia 

fetida) Tested in Artificial Soil. Project Number: E/310/2884/6. Unpublished study prepared by Bayer 

Ag, Institute of Product Info. & Residue Anal. 23 p. 
214

MRID: 46904473 

Citation: Dorgerloh, M. (2006) Acute Toxicity of BYI 08330-Ketohydroxy to Larvae of Chironomus 

riparius in a 48 h Static Laboratory Test System. Project Number: EBFN0347, E/322/2928/8, 

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 BYI 08330-enol to Larvae of Chrionomus riparius in a 

48 h Water-only Study. Project Number: EBFNX073, E/322/2929/9, MR/131/03. Unpublished study 

prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 83 p. 

MRID: 46904507 

Citation: Fischer, D. (2006) BYI08330 150 OD: Magnitude of the Residue in/on Sybeans/Wheat, 

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: SA/04181. 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: 03/P72/SI, 201300/1. 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: SA/05323. Unpublished study prepared by Bayer France. 50 p. 

MRID: 46904607 

Citation: Lemke, V. (2006) Evaluation of Acute and Chronic Dietary Exposure to BYI08330 and 

Assessment of Potential Risk. Project Number: RGFNY005. Unpublished study prepared by Bayer 

Corp. 89 p. 

MRID: 47182302 

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

13798/4114, 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 BYI 

08330 in Mallard Ducks (Anas platyrhynchos). Project Number: 13798/4116, EBFNP034. Unpublished 

study prepared by Springborn Smithers Laboratories. 119 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 Reports Discussed in Assessment
215

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.Imhoff, P.R.Hummel, 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. FAO PESTICIDE DISPOSAL SERIES 8. 

Assessing Soil Contamination: A Reference Manual. Appendix 2. Parameters of pesticides that influence 

processes in the soil. Editorial Group, FAO Information Division: Rome, 2000. 

http://www.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. 

MRID 46904508 Fischer, D. (2006) BYI08330 100 OD and BYI08330 240 SC: Magnitude of the 

Residue in/on Leafy Vegetables. Project Number: RAFNY002. Unpublished 

study prepared by Bayer Corp. 703 p. 

MRID 46904509 Freeseman, P. (2006) BYI108330 100 OD and BYI108330 240 SC: Magnitude 

of the Residue in/on 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. EPA/630/R-95/002F. 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: 

http://www.epa.gov/oppefed1/models/water/input_guidance2_28_02.htm/
216

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

http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

U.S. 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.gov/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. 

http://www.epa.gov/oppefed1/models/terrestrial/

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 1.4.1c. National 

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

http://www.epa.gov/ncea/bmds

U.S. Environmental Protection Agency. 2007. Electronic Code of Federal Regulations (e-CFR): Title 40 

Protection of Environment, Part §158.80 Acceptability of data. Updated July 16, 2007. 

http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=bc2deda1f0812438b6c5fac3554afe23&rgn=div5&view=text&node=40:23.0.1.1.9&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. 

http://www.epa.gov/ceampubl/gwater/przm3/index.htm 

http://www.epa.gov/ceampubl/swater/exams/exams2980406.htm