### 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 of science 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 labe l language stating, “Expos ure of adult bees to

direct treatment or residues on bl ooming 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 re quest 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 registra nt that the label statement, “Do not apply until after petal fall” in the specific crop sections for tree nuts, stone fruits, and pome fr uits is redundant and is already stated in the “Application Information” section. The statement, “Do not apply until after petal fall”, may therefore be removed fr om the crop specific sections.

Regarding the groundwater label amendment, sp irotetramat, spirotetramat-enol and/or spirotetramat-ketohydroxy, which ar e expected to be important components of spirotetramat total toxic residues, under particular c onditions, 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 conc ur 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 pr oposed new uses is not substantia lly altered from the most recent assessment covering the currently registered us es of spirotetramat. The ecological risk assessment findings under that review therefore pertain to this request (copy attached 1 

### ). 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 th e spirotetramat parent compound and the major degradates as they relate to pollinators have been submitted to the EFED since the last risk

assessment 2 

### . Bayer CropScience submitted a document entitled “Position Paper on Toxicity of Spirotetramat to Honey Bees” (MRID 47576401), whic h states their ration ale behind their threefold request as outlined below:

1. The condition of registration for MoventoTM for field testing with pollin ators 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.

### Page 3 of 216 

### 2. The environmental hazard statement should be amended as follows. Remove, “Exposure

of adult bees to direct treatment or residue s on blooming crops can lead to effects on honey bee larvae. See the “Directions for Us e” 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 observ ed in field testing with Movento”.

3. The restriction on cucurbits and citrus to av oid spraying before and during bloom is not necessary and should be removed. The statem ent, “Do not apply unt il 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 c ontaining 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-fie ld 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 furthe r evaluate the possible effects of spirotetramat to bee brood (MRID 472769-01), which also demonstrated the poten tial for spirotetramat to affect bee brood development.

In response to these studies, Bayer CropScience countered that these stud ies 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 contam inated crop, and therefore represent unrealistic worst-case exposure conditions. They theref ore conducted two studies, a semi-field (MRID 469044-59) test with oilseed rape and a fiel d test (MRID 469044-62) w ith flowering lacy phacelia. In both studies, no adverse effect s 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 precl uded. The EFED countered with the rationale that the tunnel study that showed effects to the bee brood exhi bited effects lower than the maximum labeled application rate. The tunnel st udy by Bayer, which did not show effects, was conducted with application rates of approximately one-half the ma ximum labeled application rate. Similarly, in the field study conducted by Bayer not only we re the highest singl e application rates approximately equal to half the maximum single proposed label applicati on rate, but the overall total application rates were appr oximately 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 wa s partly based on the nature of spirotetramat as an insecticide

### Page 4 of 216 

### that has exhibited effects to bee brood under le ss than maximum applica tion rates. The other part of the rationale was that two other related chemicals (s piromesifen and spirodiclofen) showed the potential for chronic effects to bee brood and developmen t while displaying low acute toxicity.



## Review of Recently Submitted Studies

The new studies submitted by Bayer CropScience ar e in response to the request for a field study that assesses the toxicity and e xposure 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 pol linators. 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 resu lts of each study will be presented below along

with the limitations of the studies that affect th eir ability to adequately assess the risk of spirotetramat to honey bee brood.

47563302 Assessment of effects of Spirotetrama t OD 150 on honey bee (Apis mellifera) colonies under a realistic field scen ario 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 confir m exposure after the 2 nd 

### 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 abund ance 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 treatmen t 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 gr oups as compared to the control, respectively. Furthermore, there was significantly higher mortal ity in the treatment groups before application of the test material. In summary, many of the endpoints exhibited high va riability 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 ar ose in the study. The study au thors 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 2 nd

### Page 5 of 216 

### application. The study authors di d not provide a reference for this critical thres hold. The study authors also stated that a positiv e proof of the absence of effect s could only be provided for the study period up to the T1 assessment, because th ey were uncertain abou t exposure in the period

after the 2 nd 

### application. The plots were located onl y 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 no t confirm foraging through polle n identification or exposure through pollen/nectar analysis.

47563303 Assessment of effects of Spirotetrama t 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; ho wever, the study did not confirm foraging or exposure through pollen identificat ion or pollen/nectar analysis , showed reduced foraging potential after the fourth application of the te st 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 wa s 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 re lated to this study th at 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 variab ility in bee colonies. After the fourth application of the test material, there wa s 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 shor tened flowering period. The plots were again only 3km apart. The study authors did not confirm foraging thro ugh pollen identification or exposure through pollen/nectar analysis. Finally, th e 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 Citr us 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 vari ability in the endpoints and that little citrus pollen was foraged by bees in the treatment gro up suggesting limited exposur e to the chemical.

This study assessed the effects of total spirotetramat residues to honey bee colonies in citrus crops in Spain. The chemical wa s 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 s howed 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 e ndpoints 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 an d treatment orchards would exhibit increased mortality or d ecreased 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 citr us (from 8.7% on day 26 after the second application to 23.7% on day 14 after the second applica tion) whereas in the treated or chard little citrus pollen was collected (from 1.0% on day 26 afte r 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 c ould be realistic or simply an artifact of a lack of foraging on the treated crop.

47563305 Determination of Effects of Spirotetra mat in Spiked Pollen to Honeybee Brood under Semi-Field Conditions (Trial 2008).

Classification: This study is supplemental as it illustrates the impac t of spirotetramat in a food source over a range of concentrations, but it al so revealed several limitations such as high variability in the endpoints in all treatment groups, a decrease in larv al and pupal abundance in all treatment groups until the bees were allowe d to forage, and the lack of pollen storage inside

the hive.

The purpose of this study was to assess the effect s 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 deve lopment, hive weight development, honey and pollen storage behavior, and foragi ng activity. After exposure the bees were allowed to forage

outside of the tunnels.

The study provided an assessment of total spirotetramat residue t oxicity 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, wh ich were the spiked pollen and spirotetramat free honey. The study showed no adverse effects to any endpoint, howev er the data also show ed some results that question the applicability of the st udy. 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 author s state that the bees did not store pollen because they considered the po llen 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 contro ls, showed a decreas e in larval and pu pal 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 treatment s. Finally, the differe nt treatments showed high variability in the endpoints with only three re plicates per treatment, which may be a result of natural honey bee colony variability or may mask a ny 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 th e hive and the study desi gn 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 e xposure the bees were allowed to forage outside of the tunnels. The study authors concluded that a slight transien t 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 developmen t, hive weight development, honey and pollen storage behavior, foraging activity and mortal ity 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, incl uding 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 mort ality data are pr esented 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 mo rtality could not be determine d. The honey was placed in a feeder outside of the hives, wh ereas 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 stor e pollen in the combs. The study authors state that the bees did not store pollen because they c onsidered the pollen in the petri dish inside the hive to be a part of the comb. Th is rationale should be a part of future research into this method given the propensity of honey bee be havior to store pollen and nect ar in the hives. The most important deficiency is the lack of replicates in th e study, which places th e results in question because statistical analyses cannot be performed on the data and severely limits the usefulness of the study.

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### 47563307 Residues of Spirotetramat and its metabo lites 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 blosso ms, 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 tota l residues can persist as long as 10 days after application. Total residue concentrations were 1.463 mg/kg after three hour s post application in the 72 g a.i./ha treatment and 4.690 mg/kg after th ree 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 met abolites in nectar and pollen samples of melons after spray applicatio n (tunnel test) in Spain.

Classification: This study is supplemental as it provides useful information related to the accumulation of spirotetramat in honey bee nect ar 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 fu ll flowering. The maximum concentrations based on the sampling design inside the hi ves were 0.306 mg/kg after an ap plication 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 suggest s that the study may not have captured the maximum concen trations inside the hives.

47563309 Residues of Spirotetramat and its met abolites 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 blosso ms, but it was not conducted according to any established guideline.

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### This study examined the concentrations of sp irotetramat in citrus blossoms with a total application rate of 112.5g a.i./h a 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 maximu m seasonal application amount.

47563310 Residues of Spirotetramat and its metabolit es 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 guide line, they did not describe their methods for analyzing the honeybee toxicity endpoints or cond ition 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 nect ar 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 te nded to remain high where the upper bound of total residues was 4.51 mg/kg at 10 days af ter application. However, to tal residues in nectar showed

much lower concentrations with a maximum of 0.33 mg/kg at 4 days afte r application and an upper bound of 0.23 mg/kg at 10 da ys after application. The study found no effects to any measured endpoint in the honeybee colony.

The study showed that total spirotetramat residu es 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 di d not describe their methods for analyzing the honeybee toxicity endpoints, and the source, hea lth, and age of the bees of the honeybee colony were not reported, and most importantly th e study did not have a control treatment.

47563311 Residues of Spirotetramat and its met abolites 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 est ablished guideline, they did not describe their methods for analyzing the honeybee toxicity endpoints or condition of the bees, and the study did not ha ve a control treatment.

Similar to the study on phacelia nectar and poll en, 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 re sidues in pollen and nectar were collected from inside the hive. Analysis show ed 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 con centrations with a maxi mum 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 spirot etramat 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 author s did not describe their methods for analyzing the honeybee toxicity endpoints, and the source, health, and ag e 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 metabolit es 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 a nd pollen collected from in side bee hives, but it was not conducted according to any established guideline nor di d it assess the accumulation of spirotetramat in pollen stores in the hive.

This study focused on the total residues of spirot etramat 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 residu es in nectar were collected fr om inside the hive. Analysis showed that total spirotetramat residues in nectar did not accumulate to quantifiable concentrations throughout the en tire study. The study failed to assess the accumulation potential of spirotetramat residues in pollen because ther e was not enough pollen to sample. In addition, the application rate was approximately one-half of both the maximum app lication rate and the seasonal application rate.



## EFED Response

In summary, these studies show that total spirot etramat residues will accumulate in the blossoms of various crops up to a maximum of 4.69 mg/kg af ter 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 ci trus. The residues accumulate in the pollen stores of a hive up to a maximum of 0.306 mg/kg after a treat ment 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 metabolit es the results can be mixed. The tunnel study in 2006 (47563306) showed slight transient eff ects at 10 mg/kg. The NOAEC would therefore

### Page 11 of 216 

### be 2 mg/kg based on this study. However, a si milar study in 2008 (47563 305) showed no effects at any treatment level up to 20 mg/kg. Bo th 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 in side the hives in the tunnel studies, will not be toxic to honeybees at the applic ation rates tested in the field studies. Furthermore, the tunnel studies with spiked pollen show that adverse e ffects would not occur at concentrations up to 2 mg/kg based upon the 2006 tunnel study (47563306).

Yet, as previously reviewed, th ese studies have some substantia l 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 treatmen ts even before chemical application (47563302), questions of exposure related to a decrease in blo ssom density or the lack of pollen identification analysis (47563302, 47563303), applica tion rates lower than the ma ximum 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 la ck of replicates (47563306). Al so, concentrations in citrus pollen stored inside the hives were not be as sessed in field study (47563304) even though one of the requested actions is to remove the restricti on of applying spirotetrama t to blooming citrus.

An additional limitation of the studies arises from the nature of the risk posed by spirotetramat. Previous laboratory studies show ed effects to the brood. Th e current studies show that spirotetramat may affect larval abundance (4 7563306). 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 stu dy (47563306) is questionable given the high variability in the control treatmen t endpoints, concentrations in th e 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 resu lts of the previous laboratory st udies, suggest that chronic risk needs to be the assessment goal in the field st udy. However, the maximum length of time that these studies assessed the honey bee coloni es 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 citr us or cucurbits could increase the exposure to adult bees, which would then allow the adult fora gers to return and e xpose the hive to these higher pesticide loads. The removal of the labe ling language related to both the application to blooming citrus or cucurbits and the effects to ho ney bee broods is inappr opriate considering that as previously discussed the recently submitted studi es have deficiencies that do not allow for a sufficient analysis of exposure and potential chr onic effects to the brood of honey bee colonies. These deficiencies do not provide sufficient eviden ce to alter the EFED’s assessment of the risk of spirotetramat to pollinators and beneficial ins ects 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 woul d be implemented. Some aspects of the design that should be incorporated in to a new field study should be:

• An assessment of the maximum residues that w ould be collected in the pollen and nectar over the crop season

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

• Maintain an appropriate distance betw een 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 la beled application rate and preferably the

maximum seasonal rate as well

• Report the methods for assess ing 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 th is 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 effort s of Bayer CropScience and l ooks forward to working with Bayer CropScience to further evalua te the effects of spirotetramat and its residues on pollinators. The efforts of Bayer CropScience in this evalua tion are greatly appreciat ed as this study will provide needed data to address important in formation gaps in the risk assessment.



## Groundwater Label Requirement Revision 3



## Request from Bayer CropScience

The registrant of spirotetramat, Bayer CropSci ence, also submitted applications to amend the labels of Spirotetramat Technical and its three e nd use products (as indicated in footnote #3). The registrant proposed to delete the following statements from the labels:

Technical Label : “This chemical has proper ties and characteristics a ssociated with chemicals detected in ground water. The use of this chemical in ar eas where soils are permeable, particularly where the water table is shallo w, may result in ground water contamination.”

3 Letter from L. Hodges to R. Kumar, Identified as EP A 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 submissi ons 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 na ture of the non-extractable re sidues (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 s hould remain in the label.



## EFED Response

EFED does not concur with the regi strant’s labels amendment request at this time. According to the Label Review Manual, 4 

### “The need for a ground water la bel 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 K d 

### is less than 5, or the field dissipation results indicate that the chemical leaches. For spirotetramat-ketohydroxy, which a ppears to be the most persistent of the compounds derived from spirotetramat, K d 

### ≤ 2.21 mL/g, indicating rela tively high mobility (not to mention that for spirotet ramat-enol, the range of K d 

### ’s is as low as 0.52-0.86 mL/g, and for the parent spirotetramat itself, the K d 

### ’s and K F 

### ’s are <5 mL/g as well).

Secondly, the other characteristic examin ed is the chemical’s persistence; i.e. , the hydrolysis half-life is greater than 30 days at any pH or the aerobic soil metabolism ha lf-life is greater than 2 weeks. The hydrolysis of spirotetramat-ketoh ydroxy is uncertain (it is not available), but the spirotetramat-enol, which is the precursor of th e 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-ketohydrox y is assumed to be stable to hydrolysis in the absence of additional information. Also, the aerobic soil metabolism of spirotet ramat-ketohydroxy, ranges from 1.5 to 16.7 days, with a 90 th 

### percentile of the upper confidence bound on the mean of four half-life values of 12.4 days. Al though for three of the soils, the half-lives were < 5 days, the value of 16.7 days (greater than 2 weeks) wa s obtained for the Molino sandy loam soil (from FL), with the lowest organic ca rbon content (0.93%) and the lowe st microbial biomass (this is also the only domestic soil). This may indicate th at in certain vulnerable soils, spirotetramatketohydroxy could persist (exhibit a half-life >2 weeks). As additional weight-of-evidence to support the conclusion that spirotet ramat and/or its metabolites coul d be persistent under various conditions, in the aerobic aquatic environmen ts, spirotetramat-ketohydroxy appears to be persistent (suggesting also th at 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 pres umed 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 a nd/or spirotetramat-ketohydr oxy, which are expected to be important components of spirotetramat tota l toxic residues, under particular conditions, are relatively highly mobile and persistent, and, unde r certain circumstances, as described in the label recommendation (“areas where soils are perm eable, 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 allowe d 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 esti mate 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 TerrP lant, the estimated environmenta l concentrations (EECs) were less than the highest EECs estimated in the previously conducted risk assessment, “Environmental Fate and Ecological Risk Assessme nt for the Section 3 Registration of the New Chemical Spirotetramat (DP Barcode 345278; Dated May 30, 2008)” (based on the more conservative total residues appro ach discussed in the assessment). Only EECs for terrestrial and aquatic organisms are presented below to demonstr ate 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 conc ludes that the risk picture for all proposed new uses is not substantially altered from the previously menti oned assessment covering the currently registered uses of spirotetramat. The ecological risk assessment findings under that review therefore pertain to this request (copy attached 5 

### ). 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 spirotetra mat, based on BYI 8330 150 OD Insecticide (oil dispersion) (Reg. No. 264-1051) and MOVENTOTM (suspe nsion 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 spirotetra mat, based on BYI 8330 150 OD Insecticide (oil dispersion) (Reg. No. 264-1051) and MOVENTOTM (suspe nsion 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 tartcherry, 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 spirotetra mat, based on BYI 8330 150 OD Insecticide (oil dispersion) (Reg. No. 264-1051) and MOVENTOTM (suspe nsion 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 spirotetra mat, based on BYI 8330 150 OD Insecticide (oil dispersion) (Reg. No. 264-1051) and MOVENTOTM (suspe nsion 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 concentratio ns (EECs) of spirotetramat plus degr adates 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 Uses d
(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 applica tions 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 (EC 50 = 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), acu te restricted use (0.1), and acu te 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 spirotetra mat 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 Uses c (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 applica tions 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 (EC 50 = 4620 μg a.i./L; NOAEC=1540 μg a.i./L) and marine diatoms ( Skeletonema costatum ) for non-vascular plants (EC 50 = 360 μg a.i./L; NOAEC=124 μg a.i./L). EC 50 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 environmen tal concentrations (EEC s; in mg/kg-diet) of total spirotetramat (parent + degradates) residues gene rated for the maximum spirotetramat exposure scenarios considered for the currently registered and th e 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 concen trations (EECs; in lb a.i./A) of to tal spirotetramat (parent + degradates) residues on plants following the maximum exposure scen ario 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 possibl e for spirotetramat. Specifica lly, it was assumed that spiro tetramat was not ground incorporated, it was applied at the maximum single application rate with aerial application methods (drift fraction = 0.05), an d that the solubility is greater than 100 mg/L (s olubility fraction=0.05).

b Sheet runoff

c Channelized Runoff

d For aerial applications the EEC = a pplication rate x 0.05; for ground applica tions 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, Mono cot, 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 (=Mars tonia) 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 triglochid iatus 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 (=Echinocac tus,=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 Me xican 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 (=Plecot us) 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 lentiginos us 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 lentiginos us 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 bachm ani 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 (i ncl. 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 (i ncl. 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 okeechobeens is 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 (i ncl. 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 (i ncl. 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 (Hem ignathus 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 tini folia 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 chamiss oniana 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 (S olanum 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 sandwic ense ssp. macrocephalum) Terrestrial

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

(Argyroxiphium kauense) Terrestrial Silversword, Mauna Kea ('Ahinahina) E Dicot No

(Argyroxiphium sandw icense 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 (Caesalpi nia 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 (i ncl. 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 (i ncl. 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 (i ncl. 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 (i ncl. 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 Me xican 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 (i ncl. 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 (i ncl. 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 (=Plecot us) 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 virgin ianus 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 (i ncl. 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 (i ncl. 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 chisoens is 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 viridi florus 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 (=Echinocac tus,=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 (i ncl. 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 virgin ianus 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 CH 3 

# C H 3 

# C H 3



# O C H 3

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:

N icholas E. Federoff, Wildlife Biologis t 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 ............................................................................................................................ 1 19 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 Tr ansport 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 I nhabiting 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 (Upl and) 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 dur ing 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 Insec ticide. According to the proposed label, “is active primarily by ingestion against immature insect life stages.”

Three products are formulated as suspension concentr ates 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, st one 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 th rough chemigation (sprinkler-type irrigation systems only), and are recommended to be tank-mixed with a spray adjuvant (or add itive) that enhances the systemic nature of spirotetramat by aiding infiltratio n, 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 evid ence for drawing the same conclusion for terrestrial organisms. Therefore, this assessment conserva tively assumed equivalent toxicity among them and included the two transformation products in exposur e 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 concentrati ons in the laboratory studies (spirotetramat–enol) and their persistence relative to the pare nt (spirotetramat–ketohydroxy).

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

This is the Environmental Fate and Effects Divi sion’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 re duced survival and reproduction of impacted species with subsequent effects at higher levels of biological organization.

Table I.1. Summary of En vironmental Risk Conclusions for Non-Li sted Taxa Exposed to Spirotetramat

Assessment Endpoint Identified

Concerns Summarized Risk Characteriza tion 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 invertebrate s 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

NOAEC of <28.8 mg/kg-diet (effects were seen at all tested concentrations) and all RQs are gr eater 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 curr ent 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 in sects 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 consid ered in this assessment, all RQs for upland and wetland monocots and dicots adjacent to the application site, are below the listed and non-lis ted 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 ar e 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 inve rtebrates to pesticides for screeninglevel assessments for non-endangered species. However, risks to nontarget listed and non-listed insects cannot be precluded. Although the intrinsic hazard potential to bees ba sed 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 ot her 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 w ithin a year is applied directly to soil, a very crude estimate of exposure can be derived to qualitatively compare to toxicity estimates. Base d 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 sp ecies (listed species). Additional discussion is included in Section V (“Federally Listed Threatened and Endange red Species Concerns”) of this assessment.

### Page 106 of 216 Table I.2. Potential Direct and In direct 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 inve rtebrates, 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 reptiles 1 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 amphibians 2 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 amphibi ans and reptiles; therefore, pot ential direct and indirect eff ects to endangered avian, reptilian, and amphibian species are considered equivalent.

2 Fish are used as a surrogate for aquatic phase amphibians; th erefore, potential direct and indi rect effects to endangered fish and amphibian species are considered equivalent.



### D. Exposure Characterization

Spirotetramat may degrade/ transform through various r outes, 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 DT 50 

### ’s range <<1-2.8 days). Hydrolysis in neutral and acidic environments (DT 50 

### ’s 8.6-47.6 days at pH’s 4-7 and 20- 25°C) and photolysis in sterile buffered solution (DT 50 

### = 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 shor t lived in aerobic soil environments (DT 50 

### <1 day), but could be more persistent to hydrolysis or in aquatic or anaerobic media (stable to hydrolysis; DT 50 

### = 37.9-59.0 days to aerobic aquatic metabolism; stable to an aerobic soil and aquatic metabolism). Spirotetramat-

### Page 107 of 216 ketohydroxy showed DT 50 

### ’s ranging from 1.5 to 16.7 days in aerobic soils [maximum of 24.0% of the applied radioactivity (AR)]. These results are genera lly supported by an aerobic outdoors study in which spirotetramat degraded quickly (DT 50 

### ’s of 1.1-2.9 days in two soils).

One likely route of exposure to spirotetramat to aqua tic environments will be from the contamination of surface waters from runoff events occurring shortly afte r 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 (d espite its moderately mobile classification), for its low persistence. Similar routes of exposure will be observed for spirot etramat-enol, since it is the product of the rapid breakdown of the parent.

It appears that parent spirotetramat and its majo r 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-e xtracted residues are much more persistent than the parent or its major metabolites alone. Half-lives (t 1⁄2 

### ’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 estim ated from the aerobic aquatic metabolism studies for spirotetramat + spirotetramat-enol + spirotetramat-ke tohydroxy + 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 appro ach 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 contaminat e 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 groundw ater. It appears that spirotetramat and/ or its residues may be incorporated/ transl ocated 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. The se chemicals could also be released via plant washoff to soils environments during large rain events.

The photolysis studies followed different patterns of tr ansformation/ 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 (DT 50 

### ) of 0.74 Phoenix, AZ days. Two major phototransformation products were formed besides the hydrolysis product spirotetramat-enol: methoxycyclohexylamino-carboxylic acid and methoxy-cyclohexa none (11.3-17.5% of AR). In contrast, under aqueous photolysis condition, in sterile buffered soluti on at a pH of 5, spirotetramat degraded with a DT 50 

### of 14.4 Phoenix, AZ days. In buffered solution, spirotetramat is transfor med to the major photorearrangement products spirotetramat-photo-cy clopentyl, spirotetramat-photo-hydroxymethyl, spirotetramat-photo-2-formyl and spirotetrama t-photo-2-methyl carbonate (11.5-42.9% AR). Furthermore, the soil photodegradation study was fou nd to have certain deficiencies that one could not draw definite conclusions on the rate of soil ph otodegradation. Information on the identity of the degradates in the study indicated that spir otetramat-enol, spirotetramat-ketohydroxy, methoxycyclohexanone (10% AR) a nd dimethylbenzoic acid (21.8% of AR) were observed in the

### Page 108 of 216 samples. Methoxy-cyclohexanone and dimethylbe nzoic acid were observed only in the irradiated samples.

For spirotetramat (mean K d 

### = 4.39 mL/g; mean K OC 

### = 289 mL/g OC 

### ), spirotetramat-enol (mean K OC 

### = 55 mL/g OC 

### ) and spirotetramat-ketohydroxy’s (mean K d 

### = 1.067 mL/g; mean K OC 

### = 65.3 mL/g OC 

### ), mobility was classified as moderately mobile, mobile and mobile to highly mobile, resp ectively (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-m 3 

### /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

CaCl 2 

### ), conducted in NY, FL, CA and WA, also confirm the laboratory findings of rapid degradation/ dissipation of spirotetramat (DT 50 

### ’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 spirotetra mat-enol and spirotetramat-ketohydroxy. They were not present at significant amounts below the 0-15-cm so il layer. Half-dissipation times for the combined residues of spirotetramat-enol and spirotetramat-ke tohydroxy ranged from 4.6-31.6 days, in the 0-45 cm soil depth. Spirotetramat-MA-amide was also monito red in the field, with very limited detections.

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

bioconcentrate because their K OW 

### ’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. Therefor e, regardless of whether data are for the technical grade or the formulations, they have been consid ered 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 ev idence 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 de monstrated any toxic effects to earthworms.

Although spirotetramat can be classified as practica lly non-toxic to honey bees based on acute oral and contact studies, results of brood feeding studies and tunne l 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 adu lts and pupae, massive perturbation of brood development, early brood termination, and decreased larv al 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, th ere 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 moderate ly to highly toxic to estuarine/marine invertebrates on an acute basis. Although there is no toxici ty 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 co mplete. 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, provid es only limited supplemental information and is uncertain because the parent in th e dark control samples degraded f aster than in the light exposed samples. However, from the study, the degradat es 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 p hotolysis study conducted with sterile natural water at 17.5% of AR) were identi fied 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 d escription of the role of soil photodegradation on the environmental fate of spirotetramat, and the pr esence 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 sector s (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 pr esence 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 spirotetrama t-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 w ith sterile natural water.

Spirotetramat-enol’s pKa is 5.2, which suggests that it may be ionizable at envi ronmentally relevant pH’s; however, the DT 50 

### ’s for spirotetramat-enol did not appear to depend on the soil pH’s in aerobic soil

metabolism studies conducted in four soils. Nonethel ess, 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

CaCl 2 

### solution); all the derived K d 

### ’s were within a relatively thin range (0.52-0.86) and the K OC 

### ’s did not appear to follow a pattern with the pH’s.

The available K OC 

### ’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 equ ilibrium 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 spirotetra mat (22-35% of AR) and spirotetramat-enol (40- 60% of AR). The registrant indicated that these r esidues were immobile, but it is unknown if they are bioavailable. For the purpose of calculation of the hal f-life of the total residues of spirotetramat (parent, spirotetramat-enol and spirotetramat-ketohydroxy), th e non-extracted residues were added as if they were persistent compounds.

The maximum rate of application for spirotetrama t 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 appli cations (a total maximum seasonal application rate of 0.16 lb a.i./A). However, fo r this risk assessment EFED assumed th at 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 ri sk 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 part ners associated with registration efforts for this pesticide, ecological effects data evaluation and appr oval 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 specifi cally reported, independent validation of statistical

### Page 111 of 216 results for effects studies was not performed during th e AGES reviews. In addition, a number of studies

on Movento 240 SC have been subm itted but were not formally revi ewed 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 grad e active ingredient. Unless the studies were found to contain the most sensitive endpoint available fo r a given taxonomic group based on a cursory EFED review, or they had been reviewed previously by AG ES, their details are not discussed within the body of

this assessment.

AGES found that the ecological effects database was la rgely complete and that all studies were acceptable for risk assessment purposes. However, a few additi onal data needs have been identified by EFED as

described below.

OPPTS Guideline 850.2300; Avian Reproductio n 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 obser ved at the lowest tested concentration in the available avian reproduction study w ith 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 e ffects 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 reduc tions, it is hard to indicate that these effects are not biologically significant and are c onsidered 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 st udy 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 ba sed 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 mi tes) 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 th e mode of action of these compounds (i.e., inhibition of lipid biosynthesis) may adversely affect bee br oods 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 determ ined. Therefore, it is recommended that a study design be developed in collaboration with the Environm ental 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 fo r 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 Fe deral Regulations for the re gistration 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 fi sh acute toxicity tests, an additional 96–hour LC 50 

### on the species tested in the early-life stage stud y must be submitted. These conditions apply to spirotetramat and an additional study is requested to f ill 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 Toxi city Study with a Passerine Species: Under part 158 of Title 40 in the U.S. Code of Fe deral Regulations for the re gistration of conventional pesticide products, it is stated that data are requi red on one passerine species in addition to either one waterfowl species or one upland game bird species fo r terrestrial, aquatic, forestry, and residential outdoor uses. Currently there are no acute oral t oxicity studies with passerine species available for spirotetramat. These data would be helpful for char acterizing interspecies sensitivity, and testing of a passerine addresses concerns that broad, untested avia n taxa may be more sensitive than previously required mallards and bobwhites.

Data in reserve OPPTS Guideline 850.1350; Aquatic inverteb rate life-cycle (Estuarine/Marine): Chronic toxicity data for estuarine/marine invertebra tes would be conditionally required under part 158 of Title 40 in the U.S. Code of Federal Regulations fo r the registration of conventional pesticide products

since the most sensitive acute EC 50 

### is <1mg/L and the highest estimat ed environmental concentration (EEC) in water is ≥ 0.01 of the acute EC 50 

### . However, these toxicity estimates are based on toxicity to the eastern oyster, yet the chronic life-cycle study with estuarine/marine inverteb rates is conducted with mysids. Based on mysid toxicity data, these requirement s would not be met. In addition, acute toxicity studies suggest that freshwater and estuarine/marine or ganisms 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 assessmen t 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 pr ovide 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, Fungi cide and Rodenticide Act (FIFRA), the registrant, Bayer CropScience is seeking the Section 3 registratio n for the new active ingredient, Spirotetramat, for use as an insecticide. This section of the repor t 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 m obile) broad spectrum insecticide. It is effective against chewing insects. It acts by ingestion. Its mode of action (MoA) is lip id 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 C 21 H 2 7

NO 5 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-m 3 /mol = 6.90x10 -13 atm-m 3 /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 K O W / K OW 2.51 / 324 (at pH 7)

PK

a 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 cm 2 / mol)

211 22.0 x 10 3

276 0.8 x 10 3



### Spirotetramat shows various major routes of dissipatio n: hydrolysis in alkaline media, photolysis in natural water, and biodegradation in aerobic and anaerobic environments (DT 50 

### ’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 appear s 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 meta bolism study) or to various other transformation products. It may also photolyze. Spirotetramat tota l residues (spirotetramat + transformation products spirotetramat-enol + spirotetramat-ketohydroxy + non- extracted residues) are relatively more persistent than the parent or the metabolites alone (t 1⁄2 

### ’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 K OC 

### of 289 mL/g), while both, spirotetramat-enol and spirotetramatketohydroxy are considered mobile (respective mean K OC 

### ’s of 55 mL/g OC 

### and 65.3 mL/g OC 

### ). The later two are major transformation products in the aerobic soil metabolism studies. Spirotetramat-enol was a product of the hydrolysis as well. Both chemic als 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, th ese major metabolites could be of concern in soils, sediments, and water due to their high concentrati ons in the laboratory studies (spirotetramat–enol) and their persistence relative to the parent (spirotetram at–ketohydroxy). In addition, there is insufficient evidence based on effects data to discount the potentia l 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 concentr ates or as an oil dispersion, containing 1.25 lb a.i. per gallon or 2 lb a.i. per gallon. They are app lied foliarly and the maximum total application rate in a season is 0.4 lb a.i./A. The chemical may be applie d 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, cu curbit vegetables (Crop Group 9), fruiting vegetables (Crop Group 8 plus okra), leafy vegetables (Crop Gr oup 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 Overvi ew Document (EPA 2004), this risk assessment uses a surrogate species approach in its evaluation of spirotet ramat. Toxicological data generated from surrogate test species, which are intended to be representativ e of the broad taxonomic groups mentioned above, are used to extrapolate to potential effects on a vari ety 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 di rect 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, form ulated products (e.g. “Six-Pack” studies). The open

literature studies are identified th rough 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 char acteristics 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 pes ticides 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. Acut e toxicity classifications are based on the scheme

outlined in Appendix I.

Table II.2. Test Species Evaluated for Assessing Pote ntial Ecological Effects of the Parent Spirotetramat and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity

Classification

Birds 1 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 fish 2 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 plants 3 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 bei ng available for all species listed in Table II.2 for the parent spirotetramat, there were also some acute toxicity data for the degradates. Overa ll, while the toxicity of the degradates to aquatic organisms appears to be equi valent 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 th e degradates and aquatic organisms, there were acute toxicity data for spirotetramat-enol and 4-met hoxycyclohexanone on rainbow trout (for enol only; practically non-toxic), zebra fish (for methoxycyc lohexanone 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 acu te toxicity data on midges demonstrating that both can be classified as practically non-toxic to these organisms.

For terrestrial organisms, there were acute oral t oxicity data on rats for spirotetramat-ketohydroxy, spirotetramat-desmethyl-ketohydroxy, spirotetetra mat-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, sp irotetramat-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 Movent o 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 th e 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 form ulations. 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), midge s (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 th e formulations that demonstrate the technical grade active ingredient and the formulated spirotetramat ca n both be classified as practically non-toxic. In addition, for BYI 08830 150 OD and Movento 240 SC, th ere 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, parasito id wasps, and predatory mites) that demonstrate a wide range in magnitude of acute effects.

c. Chronic

There were no chronic data available on the formulati ons, and only limited chronic data available for the degradates; one study with earthworms (4-8 week s), 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, in creased 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, d ecreased 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 developmen tal rate in the 28-day spiked-water study with midges, and decreased reproduc tion and weight and length of parents in the lifecycle study with water fleas were all chronic/re productive 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 base line risk assessment. However, in general terms, terrestrial ecosystems potentially at risk could includ e 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 he dgerows, 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 re ach 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 medi um, a point of exposure for ecological receptors, and a feasible route of exposure.

A conceptual model provides a written description and vi sual 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 hypot hesis is being employed for this baseline risk

assessment:

Spirotetramat (and its residues: spirotetramat-enol and spirotetramat-ketohy droxy), when used in accordance with the label, results in potentia l 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 spectru m tetramic acid insecticide (ketoenole) that is a lipid biosynthesis inhibitor capable of translocation w ithin 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 ar e sufficiently elevated as a result of proposed label uses. Through a preliminary iterative process of examin ing available data, the conceptual model (i.e., the representation of the risk hypothesis) has been refi ned 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 pa thways, 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 d espite retaining the basic backbone structure of the parent, this assessment conservatively assumed equiva lent toxicity among them and treated the two transformation products as well as the parent as pot ential stressors. The potential presence of these major

metabolites was accounted fo r because they may be of concern in soils, sediments, and water due to their high concentrations in the laboratory studies (spiro tetramat–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, airblastequipment, 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 s ites. Once deposited, terrestrial food items could be contaminated and available for consumption by terrestri al 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 partitioni ng coefficient, the low likelihood of volatilization of spirotetramat from soil or wa ter based on a low vapor pressure and Henry’s Law constant, the rat acute inhalation LC 50 

### (>4.183 mg/L), and the low dermal acute toxicity of the parent in the rat (LD 50 

### >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 droplet s, and oral ingestion of soil particles through incidental contact while feeding and preening.

### Page 119 of 216 In addition to spray drift, given th eir moderate to high solubility, relatively low level of binding, and low tendency to bioaccumulate/bioconcentrate, these stressor s are considered moderate ly to highly mobile and could be potentially transported to adjacent terrest rial areas, wetlands, or bodies of water via surface runoff from rain events. Thus, for aquatic receptors, th e 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 sp irotetramat in soil or water. However, while the potential for root uptake is possible given the syst emic 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 screen ing 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 meas ures 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 Agen cy’s interpretive policy and are used to indicate when a pesticide’s u se 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 a nd magnitude of adverse ecological effect, the RQ method does not provide an estimated probability of e ffect and/or magnitude of an adverse effect. However, in general, the higher the RQ, the more certa in 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 government al partners associated with regist ration efforts for this pesticide, ecological fate and effects data evaluation and appr oval 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.1 and 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 meas ures 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 met hods used to generate measures of exposure are described below, and a description of the ecological t oxicity data from which measures of effects were derived are presented in the “Effects Characterizati on” section of the assessment. A summary of the assessment endpoints and their respective measures of e xposure 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 proce sses in the agricultural fi eld, 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 th e 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, bird s, 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 observati ons 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 th e 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, da ted 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 pes ticide 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

Birds 2 Survival Bobwhite acute oral LD 50 and

bobwhite and mallard sub-acute dietary LC 50 Upper-bound residues on food items (foliar)

Reproduction and growth Mallard chronic reproduction

NOAEC and LOAEC

Mammals Survival Laboratory rat acute oral LD 50

Reproduction and growth Laboratory 2-generation rat reproduction chronic NOAEC and

LOAEC

Freshwater fish 3 Survival Rainbow trout acute LC 50 Peak EEC 4

Reproduction and growth Fathead minnow chronic (early lifestage) NOAEC and LOAEC 60-day average EEC 4

Freshwater invertebrates Survival Midge 48-hour acute EC 50 Peak EEC 4

Reproduction and growth Water flea chronic (life-cycle)

NOAEC and LOAEC 21-day average EEC 4

Estuarine/marine fish Survival Sheepshead minnow acute LC 50 Peak EEC 4

Reproduction and growth No study available 60-day average EEC 4

Estuarine/marine
invertebrates Survival Eastern oyster acute EC 50 Peak EEC 4

Reproduction and growth No study available 21-day average EEC 4

Terrestrial plants 5 Survival and growth Monocot and dicot seedling emergence and vegetative vigor

EC 25, EC 05 , and NOAEC values Estimates of runoff and spray drift

to non-target areas

Insects Survival (not quantitatively assessed) Parasitoid wasp LD 50 Maximum application rate

Aquatic plants (vascular)and algae (nonvascular) Survival and growth Duckweed (vascular) and

Skeletonema costatum (nonvascular) EC 50 and NOAEC values for growth rate and biomass

measurements Peak EEC

1 LD 50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; LOAEC = Lowest observed adverse effect concentration; LC 50 = Lethal concentration to 50% of the test population; EC 50 /EC 25 = Effect concentration to 50%/25% of the test population.

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

3 Freshwater fish may be surrogate s 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 familie s, 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, a nd 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 su mmary 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 (CropGroup 4 including amaranthvarious kinds, arugularoquette, cardoon, celery, celtuce, chervil, Chinese celery, chrysanthemum, cornsalad, garden cress, cressvarious kinds, dandelion, sorrel dock, endive, Florence fennel, lettuce-head and leaf, orach, parsley, garden and winter purslane, radicchio-redchicory, rhubarb, spinachvarious kinds, Swiss chard) 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, bitterand 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. **Cente r pivot, lateral move, side roll or overhead solid set irrigati on systems. +These are examples of crops that may have multiple seasons per year.



### Spirotetramat may be applied via conventional gro und 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 pe r 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 bios ynthesis inhibition or LBI), in a block rotation with products from other chemical classes with a differe nt mode of action in order to prevent insect’s resistance. The labels recommend that spirotetra mat’s products should be tank-mixed with a spray adjuvant/ additive that may have spreading and pene trating properties to increase the leaf uptake and systemic nature of the active ingredient within the pl ants. Nonetheless, it is indicated that sufficient leaf tissue should be present for uptake and translocation to o ccur. 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 produc t may contaminate water through runoff or drift of spray in wind. Poorly draining soils and soils with sh allow 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 contamin ation of water from rainfall runoff. It is noted, though, that such buffer strip is not mandatory. Al so, the label instructs to avoid applications when

rainfall is forecasted to occur with in 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 de liver coarse spray droplets may be used to reduce spray drift provided spray volume per acre (GPA) is incr eased to maintain crop coverage. 2) Applications more than 10 feet above the crop canopy should be avoi ded. 3) Avoid spraying during conditions of low

### Page 126 of 216 humidity and/ or high temperature (may increase the eva poration rate of spray droplets). 4) Do not apply when winds are greater than 15 mph and avoid gust y and windless conditions. 5) Avoid applications when wind direction is toward an aquatic area (can re duce risk exposure to sens itive aquatic areas). 6) Do not make an aerial or ground appli cation during temperature inversions.

The proposed label also contains an endangered speci es advisory: “The use of any pesticide in a manner that may kill or otherwise harm e ndangered 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 CH 3 C H 3 C H 3

O C H 3 373.45 IUPAC: cis-3-(2,5-dimet hylphenyl)-8-methoxy-2- oxo-1-azaspiro[4.5]dec-3-en -4-yl ethyl carbonate

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

8-methoxy-2- oxo-1-azaspi ro[4.5]dec-3-en-4-yl ethyl ester



### Table III.3 summarizes physical/ chemical and environmenta l 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 o C) 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 o C) 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 o C)/

Henry’s Law constant 5.6x10 -9 Pa = 4.2x10 -11 mm Hg

6.99x10 -8 Pa-m 3 /mol = 6.90x10 -13 Atm-m 3 /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 th e H attached to the nitrogen in spirotetramat

Octanol-Water Partition Coefficient Spirotetramat (K OW , at 20 o C) 324 –

Spirotetramat-enol

Solubility; K OW and log K OW ; pKa Solubility at 20°C, pH 5 = 0.09 g/L, pH 7 = 2.7 g/L, pH 8 = 28 g/L; K OW and log K OW at pH 5 = 109 and 2.0, respectively, at pH 7 = 2.1 and 0.3, respectiv ely, at pH9 = 0.06 and -1.3, respectively; pKa = 5.2

Spirotetramat-ketohydroxy

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

Hydrolysis Half-life Spirotetramat

[pH 4, 7, 9; (20 and 25 o C)] SFO ; pH 4, 25°C, t 1/2 = 32.5 days pH 4, 20°C, t 1/2 = 47.6 days pH 7, 25°C, t 1/2 = 8.6 days

pH 7, 20°C, t 1/2 = 13.1 days

pH 9, 25°C, t 1/2 = 0.32 days SFO=single first order kinetics.

Major metabolite – spirotetramat-enol.

Hydrolysis Half-life of spirotetramat-enol (pH 4, 7, 9; 50 o C) Stable The study was conducted for 5 days at 50 o C. .

Aqueous Photolysis Half-life t 1/2 = 14.4 Phoenix, AZ days (pH 5.0) vs.

[t 1/2 = 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; t 1/2 ’s = 0.30, 0.24, 0.26 and 0.09 days, respectively Upperbound 90 th percentile = 0.298 days DT 90 (for DFOP kinetics) = 1.26, 0.89, 0.97 and 0.34, respectively.

DFOP=double first order kinetics.

Aerobic Soil Metabolism Half-lifestudy conducted with spirotetramatenol DT 50 ’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

90 th perc. 0.117 12.38 3.99 For FL SL, SL, SiL and Si,

DT 90 for enol = 0.17, 0.07, 0.53 and 0.06 days, respectively.

Respective DT 90 for ketohydroxy= 55.6, 13.9, 16.9 and 5.1 days.

Respective DT 90 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 DT 90 = 1.8 days for LS; DT 90 could not be calculated for SiL and L. SFO=single first

order kinetics.

Anaerobic Soil Metabolism

Half-life SL; t 1/2 = 0.06 days (FOMC) The spirotetramat-enol reached a maximum amount at the last test interval; spirotetra mat-ketohydroxy was a maximum at 1 day interval. DT 90 = 1.33 days.

FOMC=first order multi-compartment

Anaerobic Aquatic Metabolism

Half-life KS CL sediment; t 1/2 = 2.8 days (SFO) DT 90 = 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; t 1/2 =1.06 and 1.05 days, respectively.

90 th percentile = 1.070 days Rates for spirotetramat-enol**, SFO :

For L and LS sediment; t 1/2 = 59.0 and 37.9 days, respectively 90 th 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 DT 90 ‘s = 3.52 and 3.50 days.

**Respective spirotetramat–enol DT 90 ‘s = 196 and 126 days.

SFO=single first order kinetics.four compartment model

Organic Carbon Partition Coefficient (K OC )and (K d ) – parent spirotetramat

Organic Carbon Partition Coefficient (K FOC ) – parent spirotetramat (mg/kg)/(mg/L) 1/n ; (K F ) – parent spirotetramat (mg/kg OC )/(mg/L) 1/n soil K OC K d K FOC K F

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 (K d )

Organic Carbon Partition Coefficient (K OC ) – spirotetramatenol Range 0.52-0.86 mL/g

27, 65, 29 and 99; mean K OC = 55 mL/g OC (mobile) SL, L, SiL and SL, respectively.

Estimated values from the soil column leaching study:

Soil Partition Coefficient (K d )

Organic Carbon Partition Coefficient (K OC ) 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/g OC Mean = 65.3 mL/g OC (mobile) SL, SiL, SiL, SL and CL, respectively

Soil Partition Coefficient (K d ) Organic Carbon Partition Coefficient (K OC ) 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/g OC

(mobile to highly mobile) SL, SiL, SiL, LS and L, respectively

Organic Carbon Partition Coefficient (K OC ), 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/g OC , respectively; a mean of 1624 mL/g OC (slightly mobile)

dimer 2, at pHs 6.0 and 1.7, 3115 and 3301 mL/g OC , respectively; a mean of 3208 mL/g OC (slightly mobile) –

Terrestrial Field Dissipation

Half-life for parent spirotetramat

Half-life for total residues ofspirotetramat-enol + spirotetramatketohydroxy and for total residues of spirotetramat + spirotetramat-enol + spirotetramat-ketohydroxy DT 50 ’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 natura l water and biodegradation in aerobic and anaerobic

### Page 129 of 216 environments (half-dissipation times or DT 50 

### ’s range <1-2.8 days). Hydrolysis in neutral and acidic environments and photolysis in sterile buffered soluti on (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 fu rther 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 mo re persistent in aquatic environments and relatively stable in anaerobic me dia. Spirotetramat’s total residues of concern (spirotetramat + spirotetramat-enol + spirotetramat-ketohydroxy, and the non-extracted residues) are more persistent than the parent and ha ve a potential to contaminate surface waters for a period of weeks to months posttreatment (via surface water runoff or ru noff accompanied with erosion), and some potential to move subsurface and contaminate groundwater in vu lnerable sites. Field dissipation studies confirm the findings of the laboratory studies, with spirotetramat dissipating with DT 50 

### ’s in the range of 0.3-1.0 days, and total residues of spirotetramat + spirotet ramat-enol + spirotetramat-ketohydroxy dissipating much more slowly.

Given the moderate to high solubility of spirotetrama t, spirotetramat-enol and spirotetramat-ketohydroxy, and their relatively low level of binding (relatively low partition coefficients, K d 

### ’s and K OC 

### ’s), and low affinity to organic matter (1-octanol/ water partition coefficient or K OW 

### ’s ≤ 324 for all three compounds), these particular chemicals could be released via plant w ash-off to soils in rain ev ents, especially if they occur shortly after application. When applied, spirotet ramat 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-targe t by spray drift (the chemical may be applied by ground and aerial methods or via airblast). It a ppears 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 wa ter (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 hi gh 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-m 3 

### /mol, respectively, at 20°C and pH 7) indicates that it is not likely to volatilize substantially. Spirotetramat’s 1-octanol/ water partition coefficient (K OW 

### ) is 324, indicating a low tendency to bioaccumulate/ bioconcentrate. For spirotetramat-enol, a major transformation product of spirotetramat, the water solubility is much higher than the one for spirotetramat (2,700 mg/L at pH 7) and the 1-octanol/ water partition coefficient is also lo w (2.1 at pH 7). For spirotetramat-ketohydroxy, the water solubility is also higher than for spirotet ramat (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 no t 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 h ydrolysis 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 appear ed 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 co rrespond 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 (max imum 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 carbona te (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 spirotet ramat was found to have certain deficiencies and definite conclusions on the rate of soil photodegrada tion 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 rela tively quickly, with calculated half-dissipation times (DT 50 

### ’s) of <1 day in three soils from the EU a nd one domestic SL soil (range 0.09-0.30 days). Furthermore, spirotetramat-enol also degraded relatively quickly, with DT 50 

### ’s of <1 day, in three soils from the EU and one domestic SL soil in a separate study conducted with the me tabolite (range 0.02-0.16 days). In the course of the spirotetramat-enol degr adation study, spirotetramat-enol showed a biphasic kinetic behavior with >80% of AR degraded by da y 1 posttreatment and slower degradation from 1 to 119 days after treatment or DAT (from 10.7 – 17.2% of the a pplied radioactivity or AR to 2.7 – 6.1% of AR).

DT 50 

### ’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 DT 50 

### ’s 1.5-16.7 days). Also, DT 50 

### ’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 DT 50 

### ’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 con ducted 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 extrac tion procedure, non-extracted residues increased to reach levels of ~40–60% of AR by 1 DAT, with no si gnificant decrease thereafter. Fractionation of the non-extracted residues showed a heterogeneous compos ition, with a high portion of fulvic acids in both studies. In an outdoor metabolism study spirotetrama t degraded with calculated half dissipation times (DT 50 

### ’s) of 1.2 and 2.9 days. Spirot etramat-enol was a maximum of 7.8%. The degradates spirotetramatglyoxylic amide and dimethyl-benzoic acid were obser ved besides the aerobic soil metabolites. The latter two compounds were also observed in the supplemen tal photodegradation on soil study, which provided

limited data. The levels of non-extracted residues we re 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 aer obic aquatic conditions, spirotetramat degraded with calculated DT 50 

### ’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.

DT 50 

### ’s for spirotetramat-enol were derive d from the study results (range of DT 50 

### ’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 me tabolites observed were also generally consistent

with the ones for the aerobic soil metabolism studies fo r 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% at1 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

DT 50 

### for the transformation of spirotetramat was calculat ed 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. Spirot etramat-enol and spirotetramat-ketohydroxy were observed under metabolism conditions, while the ot her metabolites were observed under photolytic conditions (on soil and/ or in water).

The major degradation pathway for spirotetramat unde r aerobic soil condition is hydrolytic cleavage of the ester bond of spirotetramat, yielding spirotetrama t-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 opene d to spirotetramat-MA-amide (maximum 5.2% at 1 day). In another possible pathway, demethylation ofspirotetramat-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. Informati on derived from the soil photodegradation allowed to obtain information on the presence of the degradates. In addition to the me tabolites 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 on e 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 (DT 50 

### ’s), obtained from other ki netic models were used ( e.g. single first order [SFO], double first

### Page 132 of 216 order in parallel [DFOP], single first order rever se 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 spir otetramat and its transformation products.

e. Soil Sorption, Mobility and Transport

Spirotetramat is moderately mobile in five sterilized soils, with K d 

### values ranging from 3.58-5.52 mL/g,

K OC 

### values between 184-437 mL/g OC 

### (mean 289 mL/g OC 

### ), K F 

### values ranging from 3.70-4.79 (μg/g OC 

### )/(μg/mL) 1/n 

### , K FOC 

### values ranging from 159-435 (μg/g OC 

### )/(μg/mL) 1/n 

### [mean 281 (μg/g OC 

### )/(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-ke tohydroxy 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 equilib rium test could be conduc ted on spirotetramat-enol

because the chemical was labile dur ing the adsorption phase. The mobility of spirotetramat-enol was assessed using a soil column leaching study. The ch emical 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 K OC 

### values for spirotetramat-enol were between 27-99 mL/g OC 

### (mean 55 mL/g OC 

### ) over four soil types (mobile), with K d 

### values ranging from 0.52 to 0.86 mL/g. The degradate spirotetramat-ketohydr oxy is mobile in five sterilized soils, with K d 

### values ranging from 0.529-2.28 mL/g, K OC 

### values ranging from 43.1-99.7 mL/g OC 

### (mean 65.3 mL/g OC 

### ), K F 

### values ranging from 0.516-2.21 ( μ g/g)/( μ g/mL) 1/n 

### , K FOC 

### values between 41.0-99.1 ( μ g/g OC 

### )/( μ g/mL) 1/n



### [mean 63.7 ( μ g/g OC 

### )/( μ g/mL) 1/n 

### ] and 1/n values close to unity (range 0.915-0.929, mean 0.922). The K OC 

### values were similar to the Fr eundlich adsorption constants K FOC 

### . The degradate spirotetramat-MA-amide is mobile to highly mobile in five viable soils, with K d 

### values ranging from 0.064-0.179 mL/g, K OC 

### results ranging from 4.2-25.6 mL/g OC 

### (mean 9.6 mL/g OC 

### ), K F 

### values ranging from 0.075-0.179 ( μ g/g)/( μ g/mL) 1/n



### , K FOC 

### values 4.4-25.5 ( μ g/g OC 

### )/( μ g/mL) 1/n 

### [mean 9.3 ( μ g/g OC 

### )/ ( μ g/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 an d spirotetramat-enol generally should be available for runoff only shortly after application to a few da ys after treatment. Nevertheless, spirotetramatketohydroxy, the terminal product, and the most persis tent, may be available for runoff during rain events occurring from shortly after application to several w eeks or months after application. Spirotetramatketohydroxy was observed in the laboratory at significa nt concentrations (maximum 24.0% of the AR in the aerobic soil metabolism study).

Because of their low persistence in aerobic soils, spirot etramat and spirotetramat-enol are not expected to be important leachers (despite their mobility classificati on). It is noted, however, that spirotetramat-enol is persistent in anaerobic environments. Spirotetrama t-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, formul ated as an oil dispersion, was applied once to four plots (most of which included, both, bareground and plan ted, total of 7 trials), located in the USA (FL, CA, NY and WA), dissipated rapidly with calculated half-dissipation times (DT 50 

### ’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-e nol, which degraded to spirotetramat-ketohydroxy during storage, accurate individual quantification of these metabolites is not possible. Instead, the combined residues of spirotetramat-enol and spirotet ramat-ketohydroxy were calculated. Those residues presented calculated DT 50 

### ’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 DT 50 

### ’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 be low the LOD and the LOQ by the next test interval.

g. Bioaccumulation

Spirotetramat’s 1-octanol/water partition coefficient (K OW 

### ) is 324, indicating a low tendency to bioaccumulate/ bioconcentrate. In addition, for spir otetramat-enol and spirot etramat-ketohydroxy their

K OW 

### are also low: 2.1 and 20, respectively, poi nting towards a low tendency to bioaccumulate/

bioconcentrate.

### Page 134 of 216 NH O

O O O

CH 3

CH 3 H 3 C

NH O

O CH 3

CH 3 OH

CO 2 N H

O CH 3

CH 3 OH COOH NH O H

O CH 3

CH 3 OCH 3

NH O H

O CH 3

CH 3 OH

NH O H

O CH 3

CH 3 O NH

O CH 3

CH 3

NH O

O CH 3

CH 3 OH OH

NH O

O CH 3

CH 3 OH O

N H

O CH 3

CH 3 O COOH CH 3

CH 3 O
COOH OCH 3

NH O

O CH 3

CH 3 O OCH 3

OCH 3

OCH 3

NH O H

O CH 3

CH 3

OCH 3

OCH 3

OCH 3 OCH 3 NH O

O R

R1 OH OCH 3 NH O H

O CH 3

CH 3 OH OCH 3 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

ketohydroxyDesmethylOxo-ketohydroxy Oxidation 

### *

Benzoic

acid 

### ** Methoxy cyclohexanone Molecule

cleavage

Glyoxylic amide 

### ** Oxidation



### *** x 2 (- 2 H)

Oxidation Oxidation

Ketohydroxycarboxy Oxidation

R,R 1 = -CH 3 , -COOH Oxidation

Oxidation

cleavage Molecule Dihydroxy

Oxidation Hydratization

*: postulated intermediate; ** and *** we re 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 photodegr adation on the fate of spirotetramat and/ or its transformation products. Results of the availabl e study were deemed suppl emental, providing limited data. From the study, the degradates, dimethyl-benzo ic 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 envir onmentally relevant pH’s. Nonetheless, the ionization potential of spirotetramat-e nol could affect the mobility of the chemical with the soil pH (at high pH’s high concentrations of th e “enolate” form of the chemical would occur and higher mobility is expected). In the soil column leac hing 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 e nvironment 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 tr ansformation products were not observed in the photolysis study conducted w ith sterile natural water.

Various other minor degradates were observed in the la boratory 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” appli cation 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 K OC 

### ’s for spirotetramat-enol were estimated from a series of soil column leaching studies. There is uncertainty in those values since the chem ical 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 spirotetra mat (22-35% of AR) and spirotetramat-enol (40- 60% of AR). The registrant indicated that these r esidues were immobile, but it is unknown if they are bioavailable. For the purpose of calculation of the hal f-life of the total residues of spirotetramat (parent, spirotetramat-enol and spirotetramat-ketohydroxy), th e non-extracted residues were added as if they were persistent compounds.

### Page 136 of 216 Table III.4: Chemical name, structure, molecu le 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: na a
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: na a
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 spirotet ramat-enol (degrading to spirotetramat-ketohydroxy during froz en 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 inform ation, soil hydrology, soil characteristics, crop characteristics, and the p esticide properties necessary to determine pesticide loadings to ground or surface water. This basic file co nstitutes the first part of the “exposure scenario.” It simulates the processes in the agricu ltural field, such as runoff and erosion, on a daily time step. The runoff and erosion flux output data from PRZM are u sed as chemical loadings to the Exposure Analysis Modeling System (EXAMS v. 2.98.04.06, April 25, 2 005), which simulates surface water, in order to predict the EECs. EECs for ecological risk assessme nt were determined using a pond modeling scenario

which describes a standard scenar io for the EXAMS component of the modeling exercise (EXAMS Mississippi pond).

Tables III.5 and III.6 summarize the input parameters for spir otetramat. 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 pota toes. An effort was made to model representative crops among all the crops in the label, with emphasi s on the crops with the highest seasonal application rate. Furthermore, various regions within the contin ental 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/sea son), the same minimum interval be tween 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, w ith the minimum interval between applications. There are no usage data because spirotetramat is a ne w chemical. It is unknown if these rates will be representative of the typical application rates; nevert heless, they represent a conservative estimate. Since the PRZM/ EXAMS shell (PE5.pl) allows for the in put 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 c onservative 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 applica tion 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 or der. 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 applic ations were modeled for this and three other crops that had th e maximum seasonal application rates.

For spirotetramat, the average K d 

### was a better descriptor of the mob ility 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 th e 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 resi dues of spirotetramat + spirotetramat-enol + spirotetramat-ketohydroxy + non-extracted resi dues, which were considered of concern ( Table III.6 ). Only one crop with the aerial method of applicati on was modeled (NC apples, with the highest seasonal application rate and the most conservative applica tion method). For the total residues, the average K OC 

### value (from the study of spirotetramat-ketohydroxy), was taken as a better descriptor of the mobility of the total residues since spirotetramat-ketohydroxy app ears to be the most stable of the chemicals of concern. Also, for the total resi dues, 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 d ecay. 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 aer obic soil metabolism input parameter was estimated for the total residues of spirotetramat-enol + spirot etramat-ketohydroxy + non-extracted residues (from the aerobic soil metabolism study conducted with spirotet ramat-enol). Similarly, the aerobic aquatic

### Page 138 of 216 metabolism input parameter was estimated for the tota l 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 La bel 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)

K d (mL/g) 4.39 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

and Behaviour The average K d value, as per EFED guidance on input parameters for

PRZM/EXAMS dated 2/28/02.

The K d 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 90 th percentile of the upper confidence bound on the mean of four half-life values (FL SL; t 1/2 = 0.30 days, SL; t 1/2 = 0.24 days, SiL; t 1/2 = 0.26 days, Si; t 1/2 = 0.09 days) (DFOP best fit kinetics).

Method of Application Ground and aeria l 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 (fracti on) 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 90 th percentile of the upper confidence bound on the mean of two half-life values (L sediment; t 1/2 =1.06 days, LS sediment; t 1/2 =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 t 1/2 = 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-m 3 /mol) 6.90x10 -13 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

and Behaviour ---

Environment pond298.exv --- Default for 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

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 La bel 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)

K OC (mL/g OC ) 65.32 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

and Behaviour The average K OC value, as per EFED guidance on input parameters for PRZM/EXAMS

dated 2/28/02. The K OC 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 90 th 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 possiblesignificant figures used, use of loglinear parameters) (t 1/2 = 203.82 days, t 1/2 = 169.02 days, t 1/2 = 161.16 days, t 1/2 = 203.82 days; mean = 184.455 days; std. dev. 22.58984 days).

Method of Application Aerial La bel 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 90 th
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-m 3 /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 in put parameters for the runs for the parent only. The database was substantially complete. In some inst ances 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 availa ble value was multiplied by three to account for the uncertainty due to the fact th at there was only one value. ( e.g. anaerobic aquatic metabolism – 8.4 days, from 3x2.8 days). For the aqueous photolysis, the sing le 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 metabo lism, 1.07 days for aerobic aquatic metabolism, 8.4 days for anaerobic aquatic metabolism, 13.1 da ys for hydrolysis and 14.4 days for aqueous photolysis). On the other hand, the total residues (s pirotetramat + spirotetramat-enol + spirotetramatketohydroxy) were assumed to be stable to h ydrolysis, aqueous photolys is and anaerobic aquatic metabolism (the most conservative case). These r esidues 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 in terval between applications in days.



### For the aerial runs, the peak EECs lied within a re latively 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 applicati on rate, which were also the crops with the highest peak EECs (0.395-0.573 ppb), aerial and ground applica tions were simulated. For those applications, a clear pattern was observed, with substantial decrea ses 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 Christ mas trees scenarios, respectively).

Table III.8. Estimated exposure con centrations of spirotetramat plus degradates of concern (s pirotetramat-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 in terval between applications in days.

### Page 144 of 216 The EECs for the total residues (spirotetramat + spir otetramat-enol + spirotetramat-ketohydroxy + nonextracted residues) were obtained under the most conservative scenario, with the assumptions that the total residues are stable to anaerobic aquatic metabolis m, hydrolysis and aqueous photolysis (due to the absence of data or it was inferred from the studies). Th e other half-lives were obtained by adding the total residues and watching their decay with time. The pe ak EEC for the total residues with the NC apples scenario was 20 times higher than the one for spirotet ramat 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 e xposure (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 ma terial or insects when foraging in the treated fields for nesting material or food. Therefore, for spir otetramat spray applications, estimation of pesticide concentrations in wildlife food items focuses on qua ntifying possible dietary ingestion of residues on vegetative matter and insects. The EFED terrestrial ex posure 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 estim ates 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 an d insects that may be dietary sources of exposure to avian, mammalian, reptilian, or terrestrial-phase am phibian receptors. The su rface residue concentration (ppm) is estimated by multiplying the application ra te (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 immediat ely following the application to the mass of the chemical still present on the surfaces on the day of ap plication (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 ro bust 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 we ll as a total residues appro ach that considered the residues of concern to be those of the parent sp irotetramat, spirotetramat-enol, and spirotetramatketohydroxy. To take a total residue approach, re presentative half-lives were determined based on the data from the available studies by adding the valu es 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 th e parent-only approach, representative half-lives were obtained using only the available data on the concentra tions 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 resi dues in and on plants were measured and accounted for (as opposed to just measuring dislodgeable r esidues), 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 measur ements 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, ca bbage, 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 mini mum application intervals (range from 7 to 30 days depending on the crop) are less than the calculated half-lives for both the pare nt-only and total residues approach. This suggests that the compound remains e ffective in the environment against target pest species for periods of time longer than might be sugg ested by these estimated half-lives. Whether the discrepancy between the duration of effectiveness agai nst target pests and the estimated foliar dissipation half-lives can be explained by high toxicity versus th e possibility of underestimation of persistence of the compound remains unclear. Subsequently, how we ll the patterns of dissipation observed on the agricultural crops reflects actual foliar dissipation expect ed 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 pr oposed on the label, and the minimum application interval for various crops. Risks could also be overest imated if the actual application rates, frequency of application, or number of applications are lower th an the input parameters used for the conservative exposure scenarios that were mode led for the various crops. Input va lues used for estimating avian and mammalian exposure risks to sp irotetramat 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 m odel output for the maximum terrestrial exposure scenario considered in this assessment (Pome fruit scenario based on total r esidues approach) can be

found in Appendix F

.

Table III.9. Input parameters and upper-bound and mean estimated environ mental 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 environ mental 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 a pplication 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-climb ing 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 st udies (MRID 46904508 and MRID 4690 4509) and one non-guideline study (MRID 46904507) for both the parent spirotetrama t as well as for the total residues (parent spirotetramat, spirotetramat-enol, and spirotetramat-ketohydroxy). Assuming these values are dist ributed normally, the values which represent the one tail upper 90% confidence limit of the mean half-lives for the parent and total residue approaches ar e 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 ma mmals. 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 applicati on scenarios for all crops, the parent-only approach yielded spirotetramat concentrations on foliar surf aces 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 we re highest on the surfaces of short grass for the

### Page 147 of 216 maximum pome fruit usage scenario and lowest on th e 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 quantita tively evaluate the potential exposure of terrestrial invertebrates to pesticides for screening level assess ments for non-enda ngered 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 a pplication using default assumptions for runoff and spray drift ( Table III.10 ). For runoff plus drift, TerrPlant inco rporates two similar conceptual models for depicting dry and semi-aquatic areas of terrestrial ha bitats. 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 ar ea adjacent to the treated fi eld, 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 es timated 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). Th e drift component is calculated as 1% of applied mass (for ground spray) or 5% of applied mass (for aerial sp ray, 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 base d 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 gene rated by assuming that it was not ground incorporated, and that it was applied at the maximum single appli cation 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 e quivalent 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 fo r spirotetramat-enol and spirotetramat-ketohydroxy, respectively), and the over all 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 comp ared 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 spra y drift deposition only (without a runoff exposure component) are directly compared with the most sen sitive 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 e xposure 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 emerge nce 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 mo st conservative exposure scenario possible for spirotetramat was modeled and presented in this assessment.

Table III.10. Estimated en vironmental concentrations (EECs) of to tal spirotetramat (parent + degradates) residues on plants following the maximum exposure sc enario 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 = a pplication rate x 0.05; for ground applica tions 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, effect s characterization describes the types of effects a pesticide can produce in an aquatic or terrestrial or ganism. This characterization is based on registrantsubmitted studies that describe acute and chronic e ffects toxicity informati on for various aquatic and terrestrial animals and plants. In agreement with in ternational 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 su mmaries and evaluations are available in the above

volume or in Appendix C of this assessment. Except where specifica lly reported, inde pendent validation of statistical results for effects studies was not perfo rmed during the AGES review s. In addition, a number

of studies on Movento 240 SC have b een 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 re present all species of birds, mammals, or aquatic organisms. Only a few surrogate species for both fresh water 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 re ptiles 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 fro m “practically nontoxic” to “very highly toxic” have been established for aquatic organisms (based on LC 50 

### and EC 50 

### values), mammals (based on LD 50 

### values), avian species (based on and LD 50 

### and LC 50 

### values), and non-target insects (based on LD 50 

### values

### Page 149 of 216 for honey bees) (U.S. EPA 2001). Toxicity classifi cations 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. Th erefore, 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 eviden ce for precluding similar toxicity of the degradates to the the parent for mammals, birds, gamasid mite s, and earthworms. Therefore, this assessment conservatively assumes equivalent toxicity among them.

Spirotetramat can be classified as practically non-toxic to birds (LD 50 

### >2000 mg/kg-body weight;

LC 50 

### >5000 mg/kg-diet) and mammals (LD 50 

### >2000 mg/kg-body weight) on an acute basis. Although there currently is no toxicity classification scheme fo r earthworms, based on the available information, spirotetramat appears to be of relatively low toxi city 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 (LD 50 

### 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 spirotetrama t 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 LR 50 

### greater than the highest rate tested (0.26 lb a.i./A) for a 48-hour acute contact study with pa rasitoid wasp adults exposed to dried residues on treated barley plants, to an LR 50 

### = 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, th ere 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 ava ilable vegetative vigor studies including: reduced shoot dry weight of shattercane (EC 25 

### =0.06 lb a.i./A; NOAEC=0.02 lb a.i./A); reduced length (EC 25 

### =0.09 lb a.i./A; NOAEC=0.08 lb a.i./A), dry weight (EC 25 

### =0.07 lb a.i./A; NOAEC=0.04 lb a.i./A), and fresh weight (EC 25 

### =0.20 lb a.i./A; NOAEC=0.13 lb a.i./A) of corn; reduced dry weight of ryegrass (EC 25 

### =0.15 lb a.i./A; NOAEC=0.08 lb a.i./A); reduced fresh weight of canola (EC 25 

### =0.17 lb a.i./A; NOAEC=0.06 lb a.i./A); and reduced fresh weight of oats (EC 25 

### =0.19 lb a.i./A; NOAEC=0.13 lb a.i./A).

Spirotetramat can be classified as moderately toxic to freshwater (LC 50 

### range= 1.41 to 2.59 mg a.i./L) and estuarine/marine fish (LC 50 

### =1.96 mg a.i./L), slightly to highly toxic to freshwater invertebrates (EC 50 

### range = 0.66 to >42.7 mg a.i./L), and moderately to highly toxic to estuarine/marine invertebrates (EC 50 

### 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 EC 50 

### =4.49 mg a.i./L, NOAEC=1.54 mg a.i./L) and algae (effects on biomass and gr owth rate; lowest EC 50 

### =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 bodywe ight at the lowest test level. Although no additional statistically significant effects were observe d 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 F 1 

### and F 2 

### generations; abnormal sperm cells and decreased reproductive performance in the F 1 

### males; decreased body weight (F 1 

### males and females), weight gain (P males, F 1 

### males and females), and food consum ption during lactation (P- and F 1 

### -generation females); and kidney histopathology and decreased kidney weights (F 1 

### males and females).

In the available aquatic studies, observed chronic/repr oductive effects included: d ecreased 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 in creased 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 Measu rement Endpoint

Birds Survival Bobwhite quail LD 50 >2000 mg/kg-body weight Bobwhite quail LC 50 >5000 mg/kg-diet

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

Mammals Survival Rat LD 50 >2000 mg/kg- body weight

Rat LC 50 >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 LC 50 = 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 EC 50 = 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 LC 50 = 1.96 mg a.i./L

Reproduction and growth No study available

Estuarine/marine

invertebrates Survival Eastern oyster 96-hour EC 50 = 0.85 mg a.i./L

Reproduction and growth No study available

Terrestrial plants Seedling emergence:

Non-listed Monocots

Listed Monocots EC 25 >0.16 lb a.i./A

NOAEC>0.16 lb a.i./A

Seedling emergence:

Non-listed Dicots

Listed Dicots EC 25 >0.16 lb a.i./A

NOAEC>0.16 lb a.i./A

Vegetative Vigor:

Non-listed Monocots

Listed Monocots EC 25 = 0.06 lb a.i./A

NOAEC= 0.02 lb a.i./A

Vegetative Vigor:

Non-listed Dicots

Listed Dicots 4 EC 25 >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 EC 50 = 4.49 mg a.i./L

Skeletonema costatum (non-vascular) EC 50 =0.36 mg a.i./L

Survival and growth: Listed Duckweed (vascular) 96-hou r 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 toxic ity was generated using the existing rat oral LD 50 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-die t) = >2000 mg/kg-diet].

3 Measurement endpoint was based on a study conducted with a Spirot etramat OD 150. Because a comparison of the available data su ggests that the toxicity of the technical gradeactive ingredient (TGA I) and formulated spirotetramat is roughl y equivalent (overlapping confidence inter vals), the most sensitive measurement endpoint was chosen regardless of whethe r it was based on the TGAI or a formulated product.

4 There were some effects on canola in one vegetativ e vigor study. A slightly higher, but definitive EC 25 =0.17 lb a.i./A was generated, and so was a lower NOAEC = 0.06 lb a.i./A. However, the more conservative EC 25 (>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 da ta available to evaluate th e acute effects of spirotet ramat on aquatic organisms.

Test organism Test Substance Test

condition Time Test

concentration Endpoint NOEC [mg a.i./L] EC 50 /LC 50 [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 Static b 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 Static b 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 Static b 48 hr Nominal Immobility 100 > 100 Neuhahn,

2006b

Daphnia magna (Water flea) Spirotetramatenol Static b 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 17.1 a 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 da ta available to evaluate th e acute effects of spirotet ramat on aquatic organisms.

Test organism Test Substance Test

condition Time Test

concentration Endpoint NOEC [mg a.i./L] EC 50 /LC 50 [mg a.i./L] Reference

D. subspicatus (Green alga) Spirotetramat-4- Methoxycyclohe

xanone Static b 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 spirotet ramat on aquatic o rganisms.

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 ve rtebrates.

Test Type Test Substance Test Organism Measurement Endpoint Effects Reference

Mammals

Acute oral LD 50 Spirotetramat

Technical Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Eigenberg (2004)

Acute oral LD 50 Formulation OD 150
(15.3 % a.i.) Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Schüengel (2005)

Acute oral LD 50 Formulation SC 240
(22.4% a.i.) Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg -bw None Schüengel (2005)

Acute oral LD 50 Spirotetramatketohydroxy Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Schüengel (2005)

Acute oral LD 50 Spirotetramatdesmethylketohydroxy Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Schüengel (2006)

Acute oral LD 50 Spirotetetramat-dihyroxy Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Schüengel (2006)

Acute oral LD 50 Spiroetetramat-monohyroxy Ratus norvegicus (Rat, female) LD 50 > 2000 mg/kg-bw None Schüengel (2005)

Birds

Acute oral LD 50 Spirotetramat

Technical Colinus virginianus (Northern bobwhite) LD 50 > 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

LC 50 Spirotetramat

Technical Colinus virginianus (Northern bobwhite) LC 50 > 5000 mg/kg-diet

NOAEC= 1250 mg/kg-diet No treatment-related

mortalities

Decreased body weight gain and feed consumption Barfknecht,

2004

Acute dietary

LC 50 Spirotetramat

Technical Anas platyrhynchos

(Mallard) LC 50 > 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 ch ronic/reproductive effects of spirotetrama t on terrestr ial

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 hatchlingbody 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 evalua te the effects of spirotetramat on non-target terrestrial inver tebrates.

Test Species Exposure route Test substance Endpoint Exposure

Duration Measurement Endpoint Reference

Apis mellifera
(Honey bee) Oral

Contact Spirotetramat

technical Mortality 48 hours LD 50 > 107.3 μg a.i./bee

LD 50 > 100 μg a.i./bee Schmitzer,

2004a

Apis mellifera
(Honey bee) Oral

Contact Spirotetramat

OD150 Mortality 48 hours LD 50 = 91.7 μg a.i./bee

LD 50 = 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./Aafter 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 LD 50 = 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 LD 50 = 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 LD 50 > 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 LD 50 = 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 LD 50 > 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 LD 50 > 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 EC 50/ LC 50 > 1000 mg/kg-dw soil 1

NOAEC= 1000 mg/kg-dw soil

EC 50/ LC 50 > 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 EC 50/ LC 50 > 1000 mg/kg-dw soil
NOAEC= 1000 mg/kg-dw soil

EC 50/ LC 50 > 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 EC 50/ LC 50 > 1000 mg/kg-dw soil
NOAEC= 1000 mg/kg-dw soil

EC 50/ LC 50 > 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 EC 50/ LC 50 > 1000 mg/kg-dw soil
NOAEC= 1000 mg/kg-dw soil

EC 50/ LC 50 > 1000 mg/kg-dw soil
NOAEC= 1000 mg/kg-dw soil

EC 50/ LC 50 =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 EC 50/ LC 50 >1000 mg/kg-dw soil
NOAEC= 316 mg/kg-dw soil

EC 50/ LC 50 >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 compatib ility. 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; EC 25 =0.09 lb a.i./A
Corn dry weight: NOAEC = 0.04 lb a.i./A; EC 25 =0.07 lb a.i./A

Ryegrass plant length: NOAEC = 0.08 lb a.i./A; EC 25 >0.16 lb a.i./A
Ryegrass dry weight: NOAEC = 0.08 lb a.i./A; EC 25 =0.15 lb a.i./A

No other statistical effects: NOAEC = 0.16 lb a.i./A; EC 25 >0.16 lb a.i./A Christ &

Lam 2006a Dicots

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; EC 25 >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; EC 25 =0.20 lb a.i./A

Oats fresh weight: NOAEC=0.13 lb a.i./A; EC 25 =0.19 lb a.i./A

No other statistical effects: NOAEC = 0.16 lb a.i./A; EC 25 >0.16 lb a.i./A Friedrich

2006

Dicots Brassica napus (Canola) Canola fresh weight: NOAEC=0.06 lb a.i./A; EC 25 =0.17 lb a.i./A
No other statistical effects: NOAEC = 0.16 lb a.i./A; EC 25 >0.16 lb a.i./A

Vegetative

Vigour:

Tier II 2 Monocots
Sorghum vulgare (Shattercane) Shattercane shoot dry weigh t: NOAEC=0.02 lb a.i./A; EC 25 =0.06 lb a.i./A
No other statistical effects: NOAEC = 0.19 lb a.i./A; EC 25 >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 Spir otetramat OD 150, unless otherwise indicated.

2 Conducted with Spirotetramat SC 240.



### IV. Risk Characterization

Risk characterization is the integration of expos ure 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 as sumptions, 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 gene rate RQs that are then co mpared 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 evalua ted, 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 th e 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 modeli ng 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 represen t 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 chroni c 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 modele d for estimating exposure and risk to aquatic organisms resulting from the proposed uses of spirotet ramat, 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 scen ario 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 Agen cy’s LOCs and have not been presented here. Calculated acute RQ values for freshwater and estua rine/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 an d 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, ba sed on 3 applications at a rate of 0.4 lb a.i./A/season and a 7-day interval, generate d the highest peak EECs.

b Toxicity values are based on studies with midges ( Chironomus riparius ) for freshwater invertebrates (EC 50 = 660 μg a.i./L), bluegill sunfish ( Lepomis

macrochirus ) for freshwater fish (LC 50 = 1410 μg a.i./L), eastern oysters ( Crassostrea virginica ) for estuarine/marine invertebrates (EC 50 = 850 μg a.i./L), and sheepshead minnow ( Cyprinodon variegatus ) for estuarine/marine fish (LC 50 = 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 chroni c RQs for freshwater fish and inve rtebrates 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, ba sed on 3 applications at a rate of 0.4 lb a.i./A/season and a 7-day interval, generate d the highest 21-day and 60-day EECs.

b Chronic toxicity values are based on studies with water fleas ( Daphnia magna ) for freshwater invertebrate s (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 res idues (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 vas cular 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, ba sed on 3 applications at a rate of 0.4 lb a.i./A/season and a 7-day interval, generate d the highest peak

### Page 161 of 216 EECs.

b Toxicity values are based on studies with duckweed ( Lemna gibba ) for vascular plants (EC 50 = 4620 μg a.i./L; NOAE C=1540 μg a.i./L) and marine diatoms ( Skeletonema costatum ) for non-vascular plants (EC 50 = 360 μg a.i./L; NOAEC=124 μg a.i./L). EC 50 values are used to derive RQs for non-endangered species while NOAEC values ar e 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 LO Cs for aquatic plants (1).



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

As discussed previously in the “Terrestrial Expos ure Assessment” portion of the chapter, terrestrial exposure modeling was performed using the T-REX m odel (T-REX, Version 1.3.1, dated December 7, 2006) and a parent-only approach, as well as a total re sidues approach that considered the residues of concern to be those of the parent spirotetramat, spir otetramat-enol, and spirotetramat-ketohydroxy. Risks

were estimated for terrestrial animals in three wei ght 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 numb er of applications, and the minimum application interval. However, only the most pertinent resu lts of these analyses conducted with upper-bound residues are summarized in the following tables.

For birds, acute RQs were derived using dose-based a nd dietary-based acute toxicity values, and chronic RQs were derived using a dietary-based chronic toxi city value. For mammals, acute RQs were derived using a dose-based acute toxicity value and a conserva tive estimate of acute dietary toxicity derived using methodology previously described in the “Ecological E ffects 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 equivale nt 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 fora ge categories, and toxicity values (LC 50 

### or NOAEC) are expressed in units of dietary concentration. Dose-b ased RQs are calculated using a body weight-adjusted toxicity value (LD 50 

### or NOAEL) and consumption-weighted e quivalent dose sorted by food source and body size. The adjustments account for the fact that sm aller-sized animals have to consume more food in terms of their body weight than larger animals and th at differential amounts of fo od 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 avia n 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 scenar io 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 exceede d the Agency’s acute LOCs for birds under this upper-bound exposure scenario, the RQs for all of the other scenarios are also be low the Agency’s LOCs and are not presented here.

It must be noted that chronic risk estimat es for birds are based upon a non-definitive NOAEC of <28.8 mg/kg-diet (effects were seen at all tested concen trations) 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 chroni c/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 ch ronic 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 un til a definitive NOAEC is established. Further discussion of this uncertainty is provided in the “R isk Description” section of the risk assessment.

For chronic exposure and risk estimates to birds, pa rent-only and total residues modeling approaches are presented in order to evaluate the impact of the u nderlying 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 a ll but two of the evaluated crop use scenarios for both the parent-only (RQ range = >0.82 to >1.50) and to tal 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 residu es) 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 inse cts 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) LC 50 or Adjusted Acute LD 50 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 applic ation rate of 0.14 lb a.i./A, a 7-day ap plication 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 we ight differences so that they are comparable for a given weight class of animal.

c The most sensitive LD 50 and LC 50 values for birds were non-definitive as they were determin ed to be greater than the hi ghest tested levels in the available toxicity studies. Therefore, because all acute RQs ar e based on non-definitive toxicity values, they represent conser vative 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

EECmg/kgdiet RQ EECmg/kgdiet RQ EECmg/kgdiet RQ EECmg/kgdiet RQ

Parent-Only Residues

Pome

fruit 0.14 7 3 43.10 >1.50 b 19.75 >0.69 24.24 >0.84 2.69 >0.09

Xmas

trees 0.16 14 2 40.43 >1.40 b 18.53 >0.64 22.74 >0.79 2.53 >0.09

### Page 163 of 216 Citrus

fruit 0.16 21 2 38.87 >1.35 b 17.81 >0.62 21.86 >0.76 2.43 >0.08

Tree nuts 0.14 14 3 35.47 >1.23 b 16.26 >0.56 19.95 >0.69 2.22 >0.08

Stone

fruit 0.14 14 2 35.38 >1.23 b 16.21 >0.56 19.90 >0.69 2.21 >0.08

Grape 0.125 30 2 30.06 >1.04 b 13.78 >0.48 16.91 >0.59 1.88 >0.07

Climbing 0.12 30 2 28.85 >1.00 b 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 >1.82 b 24.03 >0.83 29.50 >1.02 b 3.28 >0.11

Xmas

trees 0.16 14 2 44.55 >1.55 b 20.42 >0.71 25.06 >0.87 2.78 >0.10

Citrus

fruit 0.16 21 2 40.86 >1.42 b 18.73 >0.65 22.99 >0.80 2.55 >0.09

Tree nuts 0.14 14 3 39.85 >1.38 b 18.26 >0.63 22.41 >0.78 2.49 >0.09

Stone

fruit 0.14 14 2 38.98 >1.35 b 17.87 >0.62 21.93 >0.76 2.44 >0.08

Grape 0.125 30 2 30.59 >1.06 b 14.02 >0.49 17.21 >0.60 1.91 >0.07

Climbing 0.12 30 2 29.37 >1.02 b 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 N OAEC 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 ar e not currently exceeding but have the potential to until a definit ive NOAEC is

established.

b The chronic RQ meets or exceeds the chroni c risk LOC (1) even based on the non-defi nitive 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 Assess ment”) 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 conservativ e estimate of dietary toxicity, is less than onethird the acute endangered species LOC of 0.1. Th erefore, because no RQs exceeded the Agency’s acute LOCs for mammals under this upper-bound exposure scenario, the acute mammalia n 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 reproductio n study, based upon the NOAEC of 1000 mg/kg-diet (NOAEL = 70.7 mg/kg bw/day), the highest chr onic 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 chroni c 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 calcul ated by T-REX for the ma ximum exposure scenario. a

Type of Analysis Size

Class

(g) Acute LC 50 or Adjusted Acute

LD 50 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 applic ation rate of 0.14 lb a.i./A, a 7-day ap plication 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 we ight differences so that they are comparable for a given weight class of animal.

c A conservative estimate of dietary acute toxic ity was generated using the existing rat oral LD 50 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 LD 50 and LC 50 values for mammals were non-definitive as they were dete rmined to be greater than th e highest tested levels in the available toxicity studies. Therefore, because all acute RQs are based on non-defi nitive toxicity values, they represent co nservative 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 evalua te the potential exposure and risk of terrestrial invertebrates to pesticides for screening le vel assessments for non-endangered species.

d. Risks to Non-Target Plants Inhabiting Dry (Upland) and SemiAquatic (Wetland) Areas

As discussed previously in the “Terrestrial Expos ure Assessment” portion of the chapter, exposure and risks to upland and wetland plants was estimated us ing the TerrPlant (v1.2.2), a screening model that estimates potential exposure from a single applicati on using default assumptions for runoff and spray drift. Due to the low expected toxi city of spirotetramat to terrestrial plants, only the most conservative exposure scenario possible with TerrPlant was mode led and presented in this assessment. Specifically, estimates were generated by assuming that spirotetrama t 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 e ffect 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, becau se no RQs exceeded the Agency’s LOCs under the most conservative

### Page 165 of 216 exposure scenario possible for spirotetramat using Te rrPlant, 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 plan ts inhabiting dry (upland) and semi -aquatic (wetland) areas based on EECs of total spirotetramat (parent + degradates) res idues on plants following the maximum exposure scenario of all crops using th e TerrPlant model (lbs a.i./A). a

Application

Method;

Rate Plant Type Upland Wetland Drift Only

EEC

lbai/A NonListed

RQ b Listed RQ c EEC

lbai/A NonListed

RQ b Listed RQ c EEC

lbai/A NonListed

RQ d Listed RQ e

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 <0.5 5 0.55 <0.1 <0.1

a EECs and RQs are based on the most conservative modeling scenar io possible for spirotetramat. Specifically, it was assumed th at spirotetramat was not ground incorporated, it was applied at the maximum single a pplication rate for all uses (0.16 lb a.i/A) with aerial app lication methods (drift fraction = 0.05), and that the solubility is greater th an 100 mg/L (solubility fraction= 0.05). Refer to “Exposure Charac terization” section of

the assessment for additional information.

b The most sensitive EC 25 value from seedling emergence studies used to derive RQ s 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 are as was 0.16 lb

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

d The most sensitive EC 25 values from vegetative vigor studies us ed to derive RQs for non-listed plants e xposed 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 us ed 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 b ased on the mode of action of spirotetramat and the mobility/persistence of its major transformation pr oducts (spirotetramat–e nol 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 assess ment 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 precl uded. These concerns include risk to listed and nonlisted birds, reptiles, terrestrial-phase amphibians, and te rrestrial 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 su fficient leaf tissues are present for uptake and translocation to occur. Although there are two possi ble stereoisomers of spirotetramat, cis- and transisomers (ratio of ~98:2), the cis-isomer is the activ e 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 (s uspension concentrate), UltorTM SC (suspension

### Page 166 of 216 concentrate), and PYI 8330 OD (oil dispersion), are propo sed for use on crops such as citrus fruits, grapes and small fruit climbing, pome fruits, stone fruits, tr ee nuts plus pistachio, hops, Christmas trees, cucurbit vegetables, fruiting vegetables plus okra, leafy vegeta bles, brassica (cole) leafy vegetables, and potatoes and other tuberous and corm vegetables.

For both aquatic and terrestrial ecosystems, one majo r 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, rota ry 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 dissip ation (vapor pressure of 4.2x10 -11 

### mm Hg (20°C) and Henry’s Law constant

of 6.90x10 -13 

### Atm-m 3 

### /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 (t he two major transformation products (>10%) in the aerobic soil metabolism studies) and mineralization to CO 2



### . 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 cl eavage of the ester bond in the parent (theoretically a stoichiometric conversion). Once formed, spirotetra mat-enol is then further oxidized at the benzylic carbon in aerobic environments to yield the other ma jor metabolite, spirotetramat-ketohydroxy (maximum 24.0% in the aerobic soil metabolism study).

In addition to spray drift, given th eir moderate to high solubility, relatively low level of binding, and low tendency to bioaccumulate/bioconcentrate, spir otetramat (solubility = 29.9 mg/L at pH 7; K OC 

### = 289 mL/g OC 

### ; K OW 

### =324), spirotetramat-enol (solubility =2,700 mg/L at pH 7; K OC 

### = 55 mL/g OC 

### ; K OW 

### =2.1), and spirotetramat-ketohydroxy (solubility =228 mg/L at pH 5.7; K OC 

### = 65.3 mL/g OC 

### ; K OW 

### =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 wi de range of aquatic envi ronments to runoff is dictated by numerous varying factors including t opography, irrigation, and regional meteorological patterns, spirotetramat and spirotetramat-enol genera lly should only be available for runoff or leaching in substantial amounts up to a few days after applicati on due to their relatively low persistence in aerobic soils (DT 50 

### <1day), except in vulnerable soils with low pH and low microbial populations. On the other hand, although spirotetramat-ketohydroxy may be av ailable for leaching into groundwater and runoff to surface water for weeks or months after appli cation according to aerobic soil metabolism studies (DT 50 

### ≤ 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 de gradation/ transformation for spirotetramat include hydrolysis in alkaline media (DT 50 

### = 0.32 days at pH 9), photolysis in natural water (DT 50 

### = 0.74 Phoenix, AZ days) and biodegradation in anaerobic environments (DT 50 

### ≤ 2.8 days). In addition, under aerobic aquatic conditions, spirotetramat was mostly associated with the aqueous phase and rapidly degraded with a calculated DT 50 

### 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 (DT 50 

### = 37.9-59.0 days for spirotetramat-enol and appeared to be stable for spirotetramat-ketohydroxy).

Spirotetramat, spirotetramat-enol, and spirotetrama t-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, spirotetrama t-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 d espite retaining the basic backbone structure of the parent, this assessment conservatively assumed equiva lent toxicity among them and included the two transformation products in exposure modeling and su bsequent 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 fo r 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 w ith duckweed, in which the parent (EC 50 

### =4.49 mg a.i./L; LOAEC=6.06 mg a.i./L) and spirotetramat–enol (EC 50 

### =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 ae rial 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 th e Agency’s screening levels of concern.

However, there are a number of causes of uncerta inty regarding the aquatic risk assessment for spirotetramat. First, there is uncertainty surroundi ng 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 th ere 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 medi a...wherever the solubility and hence bioavailability are in question” (US EPA Pesticide Reregistration Re jection 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 government al partners associated with regist ration efforts for this pesticide, ecological effects data evaluation and approval respon sibilities 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 regardi ng toxicity estimates, aquatic EECs could be an underestimation of actual exposure c oncentrations in the environment. Although the label stated that spirotetramat can be applied via foliar spray appli cation 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 ri sk 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.

### Page 168 of 216 Another cause of uncertainty for the aquatic assessment is that chronic data we re only available for the fathead minnow and water fleas, yet rainbow trout an d 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 chr onic 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 (LC 50 

### >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 mo re sensitive than fathead minnow and water fleas on a chronic basis, respectively, in order to trigger excee dances of the Agency’s chronic level of concern (1). Based on predicted 60-day (0.0000563 mg a.i./L) an d 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 sp ecies used in an early-life stage toxicity test is different from the two species used for the acu te toxicity tests, an additional 96-hour LC 50 

### 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-evaluat e 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 conduct ed in the presence of sediment, the water column was spiked once, equilibrium betw een the water column, pore water, and sediment was not achieved, and test concentrations dropped rapidly. In addition, concentrations were only me asured 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 initia l measured concentrations in overlying water were close to nominal, concentrations at the other time in tervals were less than the limit of quantification (LOQ) in all test levels except the highest, wher e 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 no minal. Therefore, the applicability of the study and

its NOAEC within the context of EFED’s standard scr eening 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; emergenc e and development) in the spiked-water study, and the limited amount of spirotetramat and its major degrad ates expected to be associated with sediment (low

K OC 

### and K OW 

### 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 add ition, based on acute studies with midges ( Chironomus riparius ), both spirotetramat–enol (EC 50 

### =74.9 mg a.i./L; LOAEC=16 mg a.i./L based on 13% mortality) and spirotetramat–ketohydroxy (EC 50 

### >100 mg a.i./L; LOAEC<1 mg a.i. /L based on 5% mortality) are less

### Page 169 of 216 acutely toxic than the parent (EC 50 

### =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 screeni ng 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 rapidl y; short-term exposure primarily via water column), the expected nature of the exposure of these organisms in the envi ronment, and the lower toxicity of the degradates as compared to the parent, the NOAEC from the study b ased 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 appro ach. 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 concentr ations (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 comp ared 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 gr oup. Despite the uncertain ties 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 K d 

### is 5.52, its log K

ow 

### is ~2.5, its maximum K

oc 

### 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 n eed 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 registrati on of conventional pesticide products.

Lastly, there were no chronic data available for estua rine/marine invertebrates and fish. Chronic toxicity

data for estuarine/marine invertebrates would be cond itionally required under part 158 of Title 40 in the U.S. Code of Federal Regulations for the registrati on of conventional pesticide products since the most

sensitive acute EC 50 

### is <1mg/L and the highest estimated enviro nmental concentration (EEC) in water is

≥ 0.01 of the acute EC 50 

### . 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 terrestri al 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 chroni c 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 valu es for acute risk to birds, and acute and chronic risk to mammals, fall below the Agency’s LOCs.

Currently there is insufficient evid ence for mammals and birds to disc ount the conclusions derived based on the total residues approach. The acute toxicity data for mammals (all LD 50 

### values for the parent and

### Page 170 of 216 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 w as conducted with spirotetramat-enol and reviewed by the Office of Pesticide Program’s Health Effects Divisi on, 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 spirotetrama t-enol is of equivalent or lower toxicity than the parent. Lastly, there were two mutagenic studies av ailable, 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 pare nt for terrestrial vertebrates.

Despite the inadequacy of the toxicity data to suppor t 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 a nd results of both the parent-only and total-residue approach yield the same interpretation of risk (t he same LOC exceedances) in all but one instance (specified below).

With regards to acute risk estimates for birds, th ere are two sources of uncertainty. First, although the quail LD 50 

### of >2000 mg/kg-bw was used to generate acute oral risk quotients, the mallard LC 50 

### 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 mort ality 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; pot ential exceedance of the endangere d species LOC (0.1)). However, the fact that the highest RQ estimated using this a pproach is non-definitive and is less than the reported value (with no observed mortalities), taken in conjunction with an LD 50 

### of >2000 mg/kg-bw established for quail in the only acute oral toxicity study ava ilable, 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 mo rtality 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 sp irotetramat, the lowest spirotetramat concentration where statistically significant sub-lethal effect s 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 compar ison revealed that the highest estimated upper-bound EEC for birds that consume short grass based on the tota l 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 LC 50 

### >5000 mg/kg-diet ), it is unclear how these effects would impact the birds’ ability to survive, forage, reprodu ce, care for their young, and escape from predators in the environment. In addition, it is difficult to dete rmine 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 (M oA; 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 NOAEC of <28.8 mg/kg-diet (adverse reproductive effects were observed at the lowest tested

### Page 171 of 216 concentration in the available avian reproduction stud y with mallards) and all RQs are greater than the reported values. Therefore, there is uncertainty w ith respect to their estimated magnitude and there remains the potential for additional chronic LOC ex ceedances 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 ex ceed 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 th e RQ for birds feeding on broadleaf plants/small insects under the pome fruit scenario when using th e total residue approach (RQ = >1.02).

To bound the current estimates of risk to birds feedin g on short grass (the forage item that results in the highest exposure of spirotetramat to birds), RQs us ing mean Kenaga residue values rather than upperbound values were calculated for a ll 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 range d 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 potentia l chronic LOC exceedances cannot be precluded until a definitive NOAEC is established. Second, using th e mean Kenaga residue values for calculating RQs would not protect birds and mammals that consume f ood items that have residues on the higher end of the residue distribution. An analysis of the residue dist ribution 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 pe rcentile indicating that up to 38% of the higherend food item residue estimates are not captured by usi ng 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 Ke naga values are not a maximum exposure level.

The estimated upper-bound dietary-based EEC for tota l 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 sensitiv e NOAEC are less than the chronic LOCs for all birds. However, since there is uncerta inty with respect to the estimated magnitude of RQs (all RQs are greater than the reported values), the defi nitive rate reduction needed to lower all RQs below

the LOCs cannot be identified until a definitive NOAE C 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. A lthough 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 assess ment 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 base d on a 6.58% reduction in hatchling bodyweight at

### Page 172 of 216 this test concentration. To evaluate this further, the minimum significant difference detectable in this study for hatchling bodyweight was calculated, a nd 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 redu ction alone does not appear to be substantial.

Conversely, although no additional statistically significan t 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, b ecause of the extent of these observed effects at the lowest tested level, it is reasonable to assume th ey are significant biologically, and may warrant the request for an additional avian repr oduction study. In addition, at the 78.8 mg/kg-diet treatment level, there were effect levels up to 31% for some endpoi nts 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% fo r 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 interpretati on of spirotetramat’s risk picture with respect to chronic/reproductive effects to avian species.

In particular, a calculation of the minimum significan t difference for # of 14-day old survivors reveals that anything less than a 35% reduction from the c ontrol group could not be captured as statistically significant. Subsequently, a curve fitting approach w as 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 A pproach (BMD; US EPA, 2006) was used to fit toxicity data and then estimate to 5, 10, and 15% e ffect levels, which represent a range of effect levels that likely overlap where ecologically significant effect s may be expected to occu r. 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 th e control using either Williams’ or Dunnett’s tests.

The BMD software allows the choice of several mode ls; in this case the linear model was the simplest model that had the best fit and appeared to model the data adequately. The lin ear model generated 5, 10, and 15% effect levels of 8.3, 16.5, and 24.8 mg/kg-di et, 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 feedi ng on various food items for all modeled exposure scenarios ( Table IV.8 ).

Taken as a whole, the results from this exercise indica te 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 th is 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 bi rds feeding on broadleaf plants/small insects under the pome fruit scenario when using the total residue a pproach, exceeded the chroni c risk LOC. However, based on this exercise, there is th e potential for chronic risk LOC ex ceedances for birds feeding on short grass, tall grass, and broadleaf plants/small insects fo r 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).

### Page 173 of 216 With regards to potential exceedances, RQs for bird s feeding on short grass ranged from 1.08 (15% effect level for the least conservative modeled exposure scenari o, 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 scenari o, 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 bodywe ight, 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 th e statistically significant experimental LOAEC (28.8 mg/kg-diet). However, ecologically and statistica lly 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 w ould be more robust if an ecologically significant effect level had been identified or established, th ey suggest that species of birds that rely on a high reproductive rate for population sustainability may be the mo st susceptible to the eff ects 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 re productive NOAEC for birds, there are three major uncertainties associated with the pred icted 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 labe ls 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 ma nner 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 yea r) 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 Ag ency concerns, due to the short foliar half-life estimated for spirotetramat. As a point of referenc e, for the pome fruit exposure scenario (the one with the highest estimated exposure to terrestrial vertebra tes, the second highest application rate, and shortest interval), RQs based on total residu es for birds that feed on short grass, tall grass, broadleaf plants/small insects, and fruits/pods/seeds/large insects, increased fr om >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 applica tion 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. m odeled 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 a llow for an automated process by which to vary application rates within a given season or year, and us ing an application rate estimated by dividing the maximum seasonal application rate by the maximu m 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 scenario s 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 expl oratory analysis since this is curre ntly the Agency’s primary area of concern with respect to risks to terrestrial verteb rates based on the available data. Based on this approach, RQs based on total residues for tree nuts, gr apes, 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 th is 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 ch ronic LOC (1) exceedances.

Lastly, the Kenaga nomogram is used by T-REX to pr edict 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, est imates of risks to terrestrial vertebrates feeding on various plant forage items over time following spir otetramat 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 translo cation 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 pare nt 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 appli cation 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 evalua te the potential exposure and risk of terrestrial invertebrates to pesticides for screening level assess ments for non-endangered species. Risk estimates for terrestrial invertebrates would be complicated by th e complex and varied life histories of these types of organisms, and a lack of data on exposure pathways. Th e 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 LD 50 

### values established as >107.3 μg a.i./bee and >100 μg a.i./bee, respectively. In addition, according to othe r acute toxicity studies, a spirotetramat formulation (Spirotetramat OD 150) is also classified as practically non-toxic to bees with acute oral and contact LD 50 

### 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 in creased 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 appli cations at 0.086 lb a.i./A were made to a blooming flowering bee-attractive crop during bee flight. B ased 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 fo raging activity of the bees at an a pplication rate each of 0.086 lb a.i./A and a 7-day interval. Based on this study, neith er 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 evalua te its pollinator compatibility. These trials were not

conducted under GLP and form al reports were not prepared, but some data were submitted under FIFRA 6(a)(2). The data collected under these experiment al conditions may exaggerate exposure and are not necessarily representative of populations of bees because th e test subjects were confined in tents/tunnels and forced to forage exclusively on treated plants, desp ite that bees generally forage farther then the study allowed. However, all of the tria ls were conducted at use rates simila r to those proposed for field use in the USA (0.032 – 0.141 lb a.i./A). These trials de monstrated 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 flower ing crops, specifically after application to the crop at bloom or up to 5 days prior to bloom. Where effect s to the honey bee brood were observed, recovery was noted within 2-3 weeks. However, due to the desi gn 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 sp irotetramat applications. While it has been offered by the registrant that the tunnel tests represent ex aggerated exposure conditions by containing foraging bees to treated fields, it should also be pointed out th at 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 ra tes approximately one half the ma ximum 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 c onducted 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 th e uncertainties associated with the available field studies. However, based on the facts that spirotet ramat 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 conclu sion of this screening level risk assessment is that effects on non-target insects cannot be precluded.

Formulated spirotetramat (Spirotetramat 150 OD) ha d a wide range in magnitude of acute effects on various non-target arthropods, from an LD

50 

### greater than the highest rate t ested (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 LD

50 

### = 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 (LD 50 

### =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 (LD 50 

### =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 (LD 50 

### > 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 (LD 50 

### > 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 Fr ance and was aimed at evaluating the effects of spirotetramat on acarine mite fauna, including predator y mites, rust mites, and fungivorous mites. Based on the results, it was concluded that BYI08330 150 OD, a pplied twice at a nominal rate of 0.086 lb a.i./A or lower under a 15-day interval, or four times at a nomi nal 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 (EC 50 

### /LC 50 

### 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-dwe lling 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 LC 50 

### /EC 50 

### 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 applie d 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 es timated to be 1.20 lb a.i./year, or ~0.0134 mg

a.i./cm 2 

### . Assuming that spirotetramat is applied with a si ngle application at this annual rate directly to soil with a bulk density of 1.3 g/cm 3 

### , 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./cm 2 

### / (1.3g/cm 3 

### *1cm * 0.001kg/g) = ~10 mg a.i./kg soil) . Although this estimated con centration represents an unrealistically high exposure for the parent, let alone for the degradates, it still indi cates that soil exposure concentrations are still more

than 3 times lower than the most sensitive NOAEC cu rrently 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 e ffect 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), demonstrat es 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 curre ntly 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 estima tion 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 potentia l 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 fro m exposure via root uptake for characterization purposes only using the current NOAEC and EC 25 

### values from the available vegetative vigor study. This approach demonstrates that while all RQs for dico ts 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 potentia l 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 effe ct selection for estimating risk to dicots from exposure to drift. Only one dicot species was affect ed in the available vegetative vigour studies; canola

with an EC 25 

### =0.17 lb a.i./A and NOAEC = 0.06 lb a.i./A. Although these results generated definitive toxicity estimates, the more conservative EC 25 

### (>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 (F FDCA), 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) “m ay 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 th ere was scientific basis for including, as part of the program, the androgen- and thyroid hormone syst ems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommendation that the Pr ogram include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFR A, 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 th e resources allow, screeni ng 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 demonstr ate that dietary exposure to spirotetramat produces adverse effect on reproductive pa rameters. Observed effects in th e submitted avian reproduction studies include, but are not limited to, treatment-related d ecreases 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 reprodu ction study in mammals also show exposure to spirotetramat produces adverse effects on reproductiv e 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 F 1 

### and F 2 

### generations, and abnormal sper m cells and decreased reproductive performance in the F 1 

### males.

Results of studies evaluating chronic/reproductive eff ects 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 fl ea growth and reproduction, and decreased midge emergence and development.

Results of these reproduction studies suggest that sp irotetramat could be a candidate for additional screening and/or testing to better characteri ze 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 broadl y 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 assu med 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 ar e located within an assumed area which has the relatively highest potential exposure to the pesticid e, and that exposures are likely to decrease with

distance from the treatment area. The “Use Characteriza tion” 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 ne cessary. Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concer n for indirect effects upon listed species that depend upon the taxonomic group covered by the RQ as a res ource. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonom ic 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 sit es 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 th is information would impact the action area for a particular listed organism and may potentially in clude 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 liste d 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 occu r in proximity to listed resources, the available screening level information suggests a potentia l concern for direct effects to listed terrestrial non-target invertebrate, avian, reptilian, and amphibi an species associated with areas where spirotetramat

is used.181 Table V.1. Potential Direct and I ndirect 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 inve rtebrates, 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 reptiles 1 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 amphibians 2 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 amphibi ans and reptiles; therefore, pot ential direct and indirect eff ects to endangered avian, reptilian, and amphibian species are considered equivalent.

2 Fish are used as a surrogate for aquatic phase amphibians; th erefore, potential direct and indi rect effects to endangered fish and amphibian species are considered equivalent.



### 2. Probit Dose Response Relationship

The Agency uses the probit dose response relationshi p 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 interpre tation 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 sp ecies with sensitivity to spirotetra mat on par with the acute toxicity endpoint selected for RQ calculation. To accomplish th is 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 th e specific case of spirotet ramat, 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 mysi ds 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 relationshi p. In addition to a single effects probability estimate based on the mean, upper and lower estimates of the effects probability are also provided to182 

### 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 fro m 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 th e 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 corres ponding to the listed species acute LOCs is calculated based on the formula logLC k 

### = logLC 50 

### +(z/b), where z is the standard normal deviate and b equals the slope.

If an LD 50 

### or LC 50 

### has been established for a particular taxonomic group, but information is unavailable to estimate a slope from a study, a default slope assu mption of 4.5 is used as per original Agency assumptions of typical slope cited in Urban and Cook (1986). In instances where an LC 50 

### or LD 50 

### 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 10 12 

### . It is recognized that extrapolation of very low probability ev ents is associated with uncertainty in the resulting estimates. To explore possible bounds to such estim ates, 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 sp ecies LOC. These values are ~1 in 10.1 and ~1 in 8.25 x 10 39 

### , 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 10 13 

### . It is recognized that extrapolation of very low probab ility 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 a nd lower estimates of the effects probability associated with the listed species LOC. These values are ~1 in 3.79 x 10 5 

### and ~1 in 2.26 x 10 24 

### , 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 10 17



### . It is recognized that extrapolation of very low prob ability 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 a nd lower estimates of the effects probability associated with the listed species LOC. These values are ~1 in 1.30 x 10 10 

### and ~1 in 1.80 x 10 28 

### , 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 mort ality associated with the listed species LOC of 0.05 the acute toxic endpoint for estuarine/marine invertebrates is ~1 in 1.45 x 10 4 

### . It is recognized that extrapolation of very low probability events is associat ed with uncertainty in the resulting estimates. To explore possible bounds to such estimates, the uppe r and lower values for the mean slope estimate (0.79 to 5.06) were used to calculate upper and lower estimat es of the effects probability associated with the listed species LOC. These values are ~1 in 6.58 and ~1 in 4.34 x 10 10 

### , respectively.

Although the Agency has assumed a probit dose resp onse relationship in establishing the listed species LOCs, the available data for the toxicity stud y 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 th is dose response relationship and the listed species

LOC is low.

Birds (Barfknecht, 2003) The available acute toxicity studies (both dietar y and dose-based) on avian species were unable to establish toxicity values (LC 50 

### or LD 50 

### ). It was demonstrated that the LC 50 

### and LD 50 

### 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. Ther efore, a default slope value of 4.5 with upper and lower bounds of 2 and 9, respectively, were assume d. 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

10 5 

### . It is recognized that extrapolation of very low probability events is associated with considerable uncertainty in the resulting estimates. To explore po ssible 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 10 18



### , respectively. The uncertainty in estimated event probabilities for this taxonomic group is high based on the use of default slope estimates and large confiden ce intervals. Given the la rge uncertainty associated with the probability estimates, it is not possible to pr edict the chance of an individual mortality event for listed avian species.

Mammals (Eigenberg, 2004) The available acute toxicity studies on mammalian speci es were unable to establish toxicity values (i.e.,

LD 50 

### ). It was demonstrated that the LD 50 

### 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 estim ate an individual effects probability for mammalian species based on LD 50 

### values.

Table V.2. A summary of the probit slop e 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 10 12
(~1 in 10.1 and ~1 in 8.25 x 10 39 ) Estuarine/marine fish 5.70 (3.50, 7.70) 

### ~1 in 1.66 x 10 13


### (~1 in 3.79 x 10 5 

### and ~1 in 2.26 x 10 24 

### ) Freshwater invertebrates 6.73 (4.92, 8.54) 

### ~1 in 9.88 x 10 17


### (~1 in 1.30 x 10 10 

### and ~1 in 1.80 x 10 28 

### ) Estuarine/marine invertebrates 2.93 (0.79, 5.06) 

### ~1 in 1.45 x 10 4


### (~1 in 6.58 and ~1 in 4.34 x 10 10 

### ) Birds 4.5 (2, 9) 

### ~1 in 2.94 x 10 5184 

### (~1 in 44 and ~1 in 8.86 x 10 18 

### ) 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 scr een for indirect effects, direct effect LOCs for each taxonomic group are used to make inferences concer ning 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 us e with locations of listed species and the biologically based resources upon which they depend.

The Agency uses the dose response relationship from th e toxicity study used for calculating the RQ to estimate the probability of acute effects associated wi th an exposure equivalent to the EEC (see “Probit Dose Response Relationship” section above). In in stances where information on the dose response is available, it serves as a guide to establish the need fo r 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 a ffect” determination can be made. The degree to which additional analyses ar e 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 effe cts on a taxa, the greater the concern for potential indirect effects for listed species dependant upon that ta xa, 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 ge ographical extent of pesticide application).

Relative to spirotetramat proposed u sage, EFED’s screening level analysis shows that there is a concern for indirect effects to listed species that may depe nd 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 inve rtebrates 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 adver sely effect” determination is possible. Indirect effects analyses for organisms that depend on insects and bird s 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 criti cal habitat, consideration is given to the physical and biological features (constituent elements) of a criti cal 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 protecti on. 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 di rect and indirect effects to listed organisms.

The screening level risk assessment has identified potentia l concerns for indirect effects on listed species for those organisms dependant upon beneficial insects/terr estrial 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. Analyt ically, the identification of such species and critical185 

### 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 an y listed species. If so, EPA would examine whether the pesticide's potential impacts on non-endangered speci es would affect the listed species indirectly, or directly affect a constituent element of the critical ha bitat. 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 occupi ed 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 habita t 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 bi rds. This list should serve as an initial step in problem formulation for further assessment of critic al habitat impacts outlined above, should additional work be necessary.

E. Co-occurrence Analysis

The goal of the analysis for co-location is to determ ine 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 loca tion 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 u ses 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 th e county level for the taxon omic groups and crops of concern is not included in this ph ase of the risk assessment process.

Given that the potential extent of spirotetramat usage for the proposed uses includ es every state, and that all taxonomic groups are included in the initial LO CATES 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 Fede rally 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 wa ys: 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 th ese data, provided the information is of sufficient quality to meet FIFRA requirements. The inform ation 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 Assessment186 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 degradat ion/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 me tabolism 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 [Azaspirodecen yl-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 [Azaspi rodecenyl-3-14C]- and [azaspirodecenyl-5-14C]- labelled BYI08330-cis-enol: Comparative aerobic soil metabolism/degradation in four soils Yes BCS187 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 BY I08330 and its metabolites BYI08330-enol, BYI08330-ket ohydroxy 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 di ssipation 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 dissi pation 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 di ssipation of BYI08330 in California soil, 2004
Bayer CropScience, Stilwell, KS, USA Yes BCS188 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 di ssipation 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 Independe nt laboratory validati on of method FN-002-S05-

02 for the determination of BY I08330 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 BCS189 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 consta nt 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 [Azaspirodecen yl-3-14C]- and [azaspirodecenyl-5- 14C]BYI08330: Hydrolytic degradation Yes BCS190 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 [Azaspirodecen yl-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: Phototra nsformation 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 [Azaspi rodecenyl-3-14C]BYI08330 and [Azaspirodecenyl-5-14C]BYI 08330: 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: Determ ination of the quantum yield and

assessment of the environmen tal 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: Dete rmination of the quantum yield and

assessment of the environmen tal 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: Ae robic aquatic metabolism
Bayer CropScience AG,
Report No.: MEF-04/511,

Edition Number: M-269307-01-2 Yes BCS191 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 a nd 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 th e 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 th e 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 Deutschl and 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-Oc tanol / water of BYI 08330-enol (AE 1302944) at pH 5, pH 7 and pH 9 (Shake flask method)
Bayer CropScience Deutschl and GmbH, Frankfurt am Main, Germany
Bayer CropScience AG,
Report No.: PA06/036,

Edition Number: M-276091-01-2 Yes BCS192 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 BCS193 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 St udy 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 BCS194 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-Methoxy cyclohexanone - 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 BCS195 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 toxic ity 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 toxi city 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-Methoxy cyclohexanone - 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 BCS196 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-Methoxycycl ohexanone - 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 toxi city 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 toxic ity 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 BCS197 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 toxi city 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 BCS198 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-Oesc helbronn, 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 laborat ory 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 BCS199 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 BCS200 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 Spirotet ramat - 4-methoxycyclohexanon: Acute toxicity to earthworms (Eis enia 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 Springborn201 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 Spirotetra mat 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 pl ants: 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 BCS202 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 - magn itude 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 - magn itude 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 BCS203 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, potentia l 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 m onitoring 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 t oxicity 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 restri ction 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 No204 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 toxic ity 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 toxi city 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 A ssessment 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 BCS205 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 Evaluati ng 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: 46904447206 

### Sabbert, T.; Nuessle, C. (2004) Effect of Techni cal 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 Tec hnical 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 (t ech.) 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 1 50 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. Unpublishe d 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-e nol 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. Unpublis hed 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 Labor atory 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 Vege tative 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 Vegeta tive 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: 46904451208 

### 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 Vege tative 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 Vegeta tive 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 T echnical 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 th e 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-e nol 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: 46904437209 

### 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. Unpublis hed 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 (t ech.) 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 1 50 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. Unpublishe d 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 Labor atory 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-Di etary 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 Techni cal 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 Tec hnical 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/08 1227/01/2. 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: Vegeta tive Vigour Test on Non-Target Terrestrial Plants: Final Report. Project Number: 06/10/48/126. Unpubl ished 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 Numb er: 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 (Tie r 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 I nhibition Test with BYI 08330 (Tech.) Under StaticRenewal Test Conditions. Project Number: DOM/24019, E/412/2676/8. Unpublis hed study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 144 p.

MRID: 46904476 Dorgerloh, M. (2005) Lemna gibba G3: Growth I nhibition 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 T echnical 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 th e Freshwater Diatom Navicula pelliculosa. Project Number: EBFNX008. Unpublished study prepared by Bayer Corp. 52 p.

MRID: 46904465 Dorgerloh, M. (2006) Pseudokirchneriella subcapita ta Growth Inhibition Test with the BYI 08330 OD 150. Project Number: EBFNM006, E/323/2941/4. Unpub lished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 81 p.212 

### MRID: 46904477 Dorgerloh, M. (2005) Pseudokirchneriella subcapita ta Growth Inhibition Test with BYI 08330-enol. Project Number: EBFNM010, E/323/2816/5, 00836. U npublished 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 Af ter 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 E ffects 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-Methoxycyclo hexanon: 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 Study213 

### ------------------------------------------------------------------------------------- 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 Repor t. 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 Si de-Effects of BYI 08330 SC 240 on the Honey Bee (Apis mellifera L.) in a Feeding Test. Project Number : 200031166/01/BFEU. Unpublis hed 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-ke tohydroxy: 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 Ac ute 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 Du ck 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). Pr oject 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 G overnment Reports Discussed in Assessment215 

### Burns, L.A. 2000. Exposure Analysis Modeling Syst em (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 estimati ng pesticide residues on plants. Environ. Tox. And Chem. 13(9):1383-1391.

Food and Agriculture Organization of the Unite d Nations. FAO PESTICIDE DISPOSAL SERIES 8. Assessing Soil Contamination: A Reference Manual. A ppendix 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 resi dues on plants: correlation of representative data as a basis for estimation of their magnitude in the e nvironment. IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxi cology and Technology. Vol 1. George Theime Publishers, Stuttgart, Germany. pp. 9-28.

MRID 46904508 Fischer, D. (2006) BYI08330 1 00 OD and BYI08330 240 SC: Magnitude of the Residue in/on Leafy Vegetables. Pr oject Number: RAFNY002. Unpublished study prepared by Bayer Corp. 703 p.

MRID 46904509 Freeseman, P. (2006) BY I108330 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, In c. 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. Gu idelines for Ecological Risk Assessment. Risk Assessment Forum, Office of Research and Developm ent, 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. Ecologi cal 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. O ffice of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate a nd Effects Division, Feb. 28, 2002. Online at: http://www.epa.gov/oppefed1/models/w ater/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 Preven tion, 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. Gene ric 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. ECOT OX 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 Program s, Environmental Fate and Effects Division. December 26, 2006. Washington, D.C.

U.S. Environmental Protection Agency. 2007. Be nchmark 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 Accep tability of data. Upda ted July 16, 2007.http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=bc2deda1f0812438 b6c5fac3554afe23&rgn=div5&view=t ext&node=40:23.0.1.1.9&idno

=40

Willis, G.H., and L.L. McDowell. 1987. Pesticide Pers istence 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 Environmenta l, Inc., Leesburg, VA. p. 5-12.

http://www.epa.gov/ceampubl/gwater/przm3/index.htm

http://www.epa.gov/ceampubl/swater/exams/exams2980406.htm