### 1



# IR4 New Use for Spirotetramat on Taro Leaves, Watercress, Pomegranate, Banana, Bulb Vegetable, Low Growing Berry, Bushberry, Globe Artichoke, Fruiting Vegetable, Pome Fruit, Citrus Fruit,

Pineapple, and Coffee (PC 392201 ) ; D 398764

Date: 12

- 1 3

- 12 Prepared by: Joseph DeCant, Ecologist

José Mel é ndez

, Chemist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division

Environmental Risk Branch IV 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 Approved by: Mah Shamim, PhD, Branch Chief

### 2

Executive Summary

Spirotetramat (CAS No. 203313

- 25

- 5; CAS Name cis

- 3

- (2,5

- dimethylphenyl)

- 8

- methoxy

- 2

- oxo

1

- azaspiro[4.5]dec

- 3

- en

- 4

- yl ethyl carbonate; IUPAC Name cis

- 4

- (ethoxycarbonyloxy)

- 8

- methoxy

- 3

- (2,5

- xylyl)

- 1

- azaspiro[4.5]dec

- 3

- en

- 2

- one) is a systemic broad spectrum tetramic acid insecticide (ketoenole) that is to be applied as a preventative treatment during an early threshold of developing chewing insect populations including aphids, whiteflies and mealy bugs, when sufficient leaf tissue is present for uptake and translocation to occur within agricultural

crops

. Spirotetramat’s mode of action is lipid biosynthesis inhibition (LBI), which is classified as a Group 23 Insecticide. A ccording to the spirotetramat label it “is active primarily by ingestion against immature insect life stages.”

The Environmental Fate and Effects Division (EFED) has completed its review of a n IR

- 4 petition for the use of Spirotetramat, MOVENTOTM (Reg. No. 264

- 1050) , Ultor (Reg. No. 264

- 1065), and BYI8330 (Reg. No. 264

- 1051)

, on taro leaves, watercress, pomegranate, banana, bulb vegetable, low growing berry, bushberry, globe artichoke, fruiting vegetable, pome fruit, citrus fruit, pineapple, and coffee. The Section 3 New Chemical assessment (D345278, 05/30/2008), is

relevant to t his assessment and provides background information on the chemical, its environmental fate and transport properties, ecotoxicity, and the overall problem formulation and conceptual model for spirotetramat. The recent Section 18 assessment (D403255, 07/26/ 2012), for the use on watercress, also provides information on the risk associated with the use of spirotetramat on watercress. This assessment builds on that foundation, and relies heavily on the previous risk assessments. An evaluation of the appl icati on s to the various proposed uses suggests that this compound has potential to cause risk to the taxa identified in Table 1

.

Table 1. Summary of Environmental Risk Conclusions for Various Taxa Exposed to Spirotetramat for the Proposed Uses

Assessment Endpoint Identified Concerns Proposed Uses Associated with Risk a

Acute and Chronic Risk to

Freshwater and

Estuarine/marine Fish Acute Watercress, Cranberry

Acute and Chronic Risk to

Freshwater and

Estuarine/Marine Invertebrates Acute to all aquatic

invertebrates and Chronic

to benthic invertebrates Watercress, Cranberry

Aquatic Non

- Vascular and

Vascular Plants Risk to Non

- Vascular Watercress, Cranberry

Acute and Chronic Risk to

Birds Chronic Watercress, Banana/Plantain, Globe Artic hoke, Citrus, Pome, Bushberry/Low Growing Berry, Coffee, Pineapple, Pomegranate, Bulb Vegetables

Acute and Chronic Risks to

Mammals Chronic Banana/ Plantain

### 3

Risks to Upland and Wetland

Plants None N/A

Concerns to Terrestrial Non

Target Insects Acute and Chronic Citrus, Bushberry/Low Growing Berry, Pome, Coffee, Bulb Vegetable

Risks to Earthworms None N/A

a N/A = Not Applicable



### Summary of Exposure and Associated Risk Conclusions

The environmental fate database is substantially complete

. Additional fate data uncertainties are

listed in Table 2

.

Table 2 . Environmental Fate Data Requirements for Spirotetramat

Guideline

Number Data Requirement MRID# Study

Classification Are Additional

Data Needed for

Risk Assessment?

Non

- guideline Nature of NERs of Spirotetramat 47576501 Supplemental Yes 1

1 The registrant should provide additional information characterizing the NERs. Unless proven otherwise, EFED will consider the NERs as repositories of toxic material

.



### In order to simplify this document, certain data has been appended as described in Table 3

.

Table 3 . Organization of the Appendices in this Risk Assessment Appendix Title of Appendix Page

A Use i nformation for s pirotetramat n ew u ses 2012 14

B Aquatic e x posure a ssessment for the new u ses of s pirotetramat 2012 18

C Agency risk quotient (RQ) metrics and levels of concern (LOC s ) per risk class 33

D Evaluation of the nature of n on

- extracted r esidues (NERs) in s pirotetramat

m etabolism s tudies (MRID 47576501 ) 34

E Terrestrial e xposure a ssessment for the n ew u ses of s pirotetramat 2012 38



### The majority of the proposed use rates are equal to or less than previously registered uses.
However, as Table A

- 1 in Appendix A shows, for bananas and watercress the proposed use rates are higher than previously registered uses. In addition, the use on cranberry and watercress

represent aquatic use pattern s . The increase in the use rates and the type of application for both

wate rcress and cranberry result ed in higher aquatic EECs.

Aquatic Risk Summary A summary of the aquatic EEC’s along with the related risk quotients is presented in Tables 4

and 5 (for acute and chronic risk, respectively)

.

For the proposed terrestrial agri cultural uses , the Florida citrus scenario, which was used as a surrogate for the proposed use on bananas and plantains, is the most conservative scenario with the highest aquatic EECs. This scenario as shown at the top of Table s 4 and 5 reveals that ther e are no exceedances of levels of concern (LOCs) , for parent alone or for the total toxic residues,

### 4

for any taxa related to acute and chronic exposure to aquatic animals or to exposure to aquatic

vascular and non

- vascular plants. Consequently, EFED conclu de s that the terrestrial agricultural uses do not pose any risk concern to aquatic taxa.

However, the aquatic agricultural uses on watercress and cranberry present risk concerns. Utilizing a Tier 1 aquatic tool ( i.e. , the Modified Tier 1 Rice Model , see the Appendix B ), EEC’s for the watercress and cranberry uses reveal that parent spirotetramat, when considered alone

, does not pose a concern for the most part, either acute or chronic, to any aquatic taxa. The one exception is a slight exceedance o f the LOC for acute endangered species for the proposed use

on watercress (RQ = 0.0 58 for freshwater invertebrates, compared to an LOC of 0.05) . The primary issue, rather, is the role of the degradates and the non

- extracted (or un

- extracted) residues (NER s ). The consideration of the NERs is explained in detail in Appendix D

.

As Table 4 shows, when the total toxic residues (TTR) and NERs are included in the expression

of the EECs , the proposed use on watercress exceeds the acute risk LOC for freshwater

invertebrates. Chronic risk to benthic invertebrates is also a concern ( Table 5 ) . Furthermore, the EEC’s exceed the acute endangered species and the acute restricted use LOCs for freshwater and saltwater invertebrates and fish, while also exceeding the a quatic non

- vascular plant LOC.

Similarly, the proposed use on cranberry poses risk concerns to aquatic taxa. W hen the TTRs and NERs are included regardless of the timing of application, the RQ s exceed the acute restricted use and acute endangered species LOCs for freshwater invertebrates and fish as well as saltwater invertebrates. In this scenario, the acute endangered species LOC is also exceeded for saltwater fish as well as chronic risk being present for benthic invertebrates. Even w hen the

NERs are excluded, there is still acute restricted use and acute endangered species exceedances

of the LOCs to those taxa highlighted in Table 4 , as well as chronic concern for benthic invertebrates, when applications are made one day pre

- flood. The concerns are entirely mitigated when the NERs are excluded and applications must be made no closer to the flood period than 30 days, but note that NERs are not taken into account and may underestimate the risk associated with this use of spirotetramat.

Table 4

. Upper bound exposure and acute risk to aquatic animals and risk to aquatic plants.
Acute Aquatic Animals a Aquatic Plants b

Crop Scenario/App.

rate/No. Apps/Int.

Between Apps. EEC/ppb Freshwater

Invertebrates Freshwater

Fish Estuarine/

Marine

Invertebrates Estuarine/

Marine

Fish Vascular c Non

Vascular (non

listed/ listed)

Terrestrial Uses

FL citrus

0.25/ 5/ 14 1.46 0.0022 0.0010 0.0017 0.00075 0.00095 0.0041/

0.012

FL citrus

TTR + NERs

0.25/ 5/ 14 19.6 0.030 0.014 0.023 0.01 0.013 0.054/

0.16

Aquatic Uses

Watercress

### 5

Table 4

. Upper bound exposure and acute risk to aquatic animals and risk to aquatic plants.
Acute Aquatic Animals a Aquatic Plants b

Crop Scenario/App.

rate/No. Apps/Int.

Between Apps. EEC/ppb Freshwater

Invertebrates Freshwater

Fish Estuarine/

Marine

Invertebrates Estuarine/

Marine

Fish Vascular c Non

Vascular (non

listed/ listed)

Spirotetramat only

0.2/ 2/ 7 38.6 0.058 0.027 0.045 0.020 0.025 0.11/

0.31

TTR + NERs

0.2/ 2/ 7 393 0.60 0.28 0.46 0.20 0.26 1.1/ 3.2

TTR (excluding the NERs)

0.2/ 2/ 7 373 0.57 0.26 0.44 0.19 0.24 1.0/ 3.0

Cranberry Spirotetramat only

0.16/ 3/ 7

– 1 d

pre

- flood 5.50 0.0083 0.0039 0.0065 0.0028 0.0036 0.02/

0.044

TTR + NERs

0.16/ 3/ 7 1 d pre

- flood 162 0.25 0.11 0.19 0.083 0.11 0.45 / 1.3

TTR + NERs

0.16/ 3/ 7 30 d pre

- flood 141 0.21 0.1 0.17 0.072 0.10 0.39 / 1.1

TTR (excluding the NERs)

0.16/ 3/ 7 1 d pre

- flood 114 0.17 0.081 0.13 0.058 0.074 0.32/

0.92

TTR (excluding the NERs)

0.16/ 3/ 7 30 d pre

- flood 22.4 0.034 0.016 0.026 0.011 0.015 0.062/

0.18

a Toxicity values are based on studies with midges ( Chironomus riparius ) for freshwater invertebrates (EC 50 = 660 μ g a.i./L), bluegill sunfish ( Lepomis macrochirus ) for freshwater fish (LC 50 = 1410 μ g a.i./L), eastern oysters ( Crassostrea virginica ) for estuarine/marine invertebrates (EC 50 = 850 μ g a.i./L), and sheepshead minnow ( Cyprinodon variegatus ) for estuarine/marine fish (LC 50 = 1960 μ g a.i./L).

b Toxicity values are based on studies with duckweed ( Lemna gibba ) for vascular plants (EC 50 = 4620 μ g a.i./L; NOAEC=1540 μ g a.i./L) and marine diatoms ( Skele tonema costatum ) for non

- vascular plants (EC 50 = 360 μ g a.i./L; NOAEC=124 μ g a.i./L).

c RQ’s are based on plant toxicity NOAEC’s. There are would also be no exceedances if the RQ’s were based on the EC 50 because the NOAEC is a more sensitive endpoint than the EC 50

.

Table 5

. Upper bound chronic exposure and risk quotients for aquatic invertebrates and fish. a

Crop Scenario/App. rate/No. Apps/Int. Between Apps. Chronic /ppb (21d/60d) b Freshwater Free

swimming Invertebrates Benthic

Invertebrates Freshwater

Fish

Terrestrial Uses

FL citrus

0.25/ 5/ 14 0.0622/

0.0462 0.000031 0.00062 0.00012

FL citrus TTR

0.25/ 5/ 14 18.7/ 17.5 0.0094 0.19 0.035

### 6

Table 5

. Upper bound chronic exposure and risk quotients for aquatic invertebrates and fish. a

Crop Scenario/App. rate/No. Apps/Int. Between Apps. Chronic /ppb (21d/60d) b Freshwater Free

swimming Invertebrates Benthic

Invertebrates Freshwater

Fish

Aquatic Uses

Watercress Spirotetramat only

0.2/ 2/ 7 1.99/ 0.695 0.0010 0.020 0.0037

TTR + NERs

0.2/ 2/ 7 381/ 359 0.19 3.81 0.71

TTR (excluding the NERs)

0.2/ 2/ 7 361/ 338 0.18 3.61 0.68

Cranberry Spirotetramat only

0.16/ 3/ 7

– 1 d pre

- flood 0.283/

0.0991 0.00014 0.0028 0.00053

TTR + NERs

0.16/ 3/ 7

– 1 d pre

- flood 157/ 148 0.079 1.57 0.29

TTR + NERs

0.16/ 3/ 7

– 30 d pre

- flood 137/ 129 0.069 1.37 0.26

TTR (excluding the NERs)

0.16/ 3/ 7

– 1 d pre

- flood 110/ 103 0.055 1.1 0.21

TTR (excluding the NERs)

0.16/ 3/ 7

– 30 d pre

- flood 21.6/ 20.3 0.012 0.22 0.040

a Chronic toxicity values are based on studies with water fleas ( Daphnia magna ) for freshwater invertebrates (NOAEC = 2000 μ g a.i./L) and fathead minnows ( Pimephales promelas ) for freshwater fish (NOAEC = 534 μ g a.i ./L). For benthic invertebrates, the chronic toxicity value is

based on Chironomus riparius (NOAEC = 100 μ g a.i./L).

b Chronic 21 day and 60 day average exposure concentrations are shown. The 21 day average relates to aquatic invertebrates whe reas the 60 day exposure concentrations relate to fish.



### As is evident from the above tables, the NERs make a substantial contribution to the overall risk picture for aquatic plants and animals, but only in the case of the aquatic uses. When

s pirotetramat is modele d alone , it does not pose a concern to aquatic taxa, with the exception of

the use on watercress , where there is a slight exceedance of the acute endangered species LOC

for freshwater invertebrates (RQ = 0.06) . The registrant has not provided information related to

the inherent toxicity or identification of the possible compounds present in these NERs . The only rationale that the registrant has provided relates to the environmental fate of these residues

as outlined in Appendix D . EFED maintains that the se residues are environmentally relevant, which underscores the uncertainty related to the toxicity of these residues. It is possible that the RQs above may overestimate the risk due to the potential that the toxicity of spirotetramat is due to the parent and the main degradates that are considered toxic. Yet there is no information to refute the assumption that the NERs are also toxic. Note that for the cranberry use, if applications are made 30 days prior to flooding and if data show that the NERs are of no concern toxicologically , then RQs are below LOCs

. Thus, the application timing can remove all risk

concerns to aquatic organisms for the cranberry use ( i.e. , imposing a 30

- day pre

- flood restriction) . For the watercress use, there would be risk whether the NERs are considered toxic

or not and restrictions such as the ones for cranberry could not be imposed

. Watercress cultivation requires that the crop be flooded all throughout the growing period.

Besides the fact that the model functions as a Tier 1 tool, certain uncertainties surround the use

of the Modified Tier I Rice Model for cranberry and watercress use . They have been described in previous Section 18 reviews (DP Barcodes D399023

, dated 04/20/2012

, and D403255, dated

### 7

07/26/2012) , and in the Appendix B

. It is noted that the endpoint s of the freshwater invertebrate organisms using the midge, Chironomus riparius

, w ere compared against the water column peak

and 21

- day EECs in the absence of pore water EECs. Using the Modified Tier 1 Rice Mo del, benthic sediment or pore water EECs cannot be estimated and a Tier 2 tool would be needed

, such as the Pesticide Flooded Application Model (PFAM), which is currently being tested for quality assurance in EFED

.

Terrestrial Risk Summary A summary of terrestrial risk is found in Tables 6 through 9

. Since the application rates and intervals between applications are similar to previous uses, r isk conclusions from the previous S3

New Chemical assessment (D345278) can be used in place of a ne w assessment for the majority of proposed uses. EFED selected two of the proposed uses that represent the highest application rates that have not been assessed in previous reviews. These higher use rates are for watercress and banana/plantain. For each crop application scenario based on maximum application rates, minimum application intervals, and the maximum number of applications, the use of spirot et ramat, as parent alone or as total toxic residues, does not pose a concern to either birds or

mammals on an acute exposure basis. Chronic exposure presents a concern, however. As Table

8 shows, the EECs exceed the chronic LOC for birds under both crop scenarios whether parent alone or total toxic residues are considered. However, the chronic risk for mamm als only appears when considering small mammals that use short grass as a food source and considers the total toxic residues. It is important to note that the actual chronic exposure levels as shown by Figure s E

- 1 to E

- 4 in Appendix E reveal that peak exp osure crosses the toxic effects threshold multiple times for both birds and mammals, which increases the likelihood of chronic effects that are reflected in the LOC exceedances. Furthermore, the chronic no

- effect endpoint for birds is

uncertain as toxic e ffects were found at the lowest treatment level , which suggests that the chronic RQs for birds may actually be greater than what was calculated

.

Table 6

. Upper bound a cute dose

- based Risk Quotients u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds

.

Use RQ’s

Size

class a Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods Seeds

Parent only b

Watercress Small 0.05 0.02 0.03 0.02 0.00 0.00

Banana/

Plantains Small 0.05 0.02 0.03 0.02 0.00 0.00

Total Residues b

Watercress Small 0.05 0.02 0.03 0.02 0.00 0.00

Banana/

Plantains Small 0.06 0.03 0.03 0.02 0.00 0.00

### 8

Table 6

. Upper bound a cute dose

- based Risk Quotients u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds

.

Use RQ’s

Size

class a Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods Seeds

a There are three size classes of birds including small (20g), medium (100g), and large (1000g). Small birds represent the mos t sensitive size class and therefore the lack of risk concern to small birds from upper

- bound exposure concentrations implies that there will also not be risk to

other sizes of birds.

b For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and

one non

- guideline study (MRID 46904507) for both the parent sp irotetramat as well as for the total residues ( parent spirotetramat, spirotetramat

enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90%

confidence limit of the mean half

- l ives for the parent and total residue approaches are 3.3 and 5.3 days, respectively.

Table 7

. Upper bound a cute and chronic dosed

- based Risk Quotients u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for mammals

.

Use RQ’s (acute/chronic)

Size

class a Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods Seeds

Parent only b

Watercress Small 0.01/0.03 0.01/0.01 0.01/0.01 0.01/0.01 0.00/0.00 0.00/0.00

Banana/

Plantains Small 0.01/0.03 0.01/0.01 0.01/0.02 0.01/0.01 0.00/0.00 0.00/0.00

Total Residues b

Watercress Small 0.01/0.03 0.01/0.01 0.01/0.02 0.01/0.01 0.00/0.00 0.00/0.00

Banana/

Plantains Small 0.02/0.03 0.01/0.01 0.01/0.02 0.01/0.01 0.00/0.00 0.00/0.00

a There are three size classes of mammals including small (15g), medium (35g), and large (1000g). Small mammals represent the most sensitive size class and therefore the lack of risk concern to small mammals from upper

- bound exposure concentrations implies that there will also not be

risk to other sizes of birds.

b For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and

one non

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

enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90%

confidence limit of the me an half

- lives for the parent and total residue approaches are 3.3 and 5.3 days, respectively.

Table 8

. Upper bound c hronic dietary

- based Risk Quotients u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds and mammals

.

Use Taxa Dietary Based RQ’s

Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits, Pods

, Seeds Parent only a

Watercress Bird 2.05 0.94 1.15 0.80 0.13

Mammal 0.83 0.38 0.47 0.05 0.33

Banana/ Plantains Bird 2.20 1.01 1.24 0.86 0.14

Mammal 0.90 0.41 0.50 0.35 0.06

### 9

Table 8

. Upper bound c hronic dietary

- based Risk Quotients u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds and mammals

.

Use Taxa Dietary Based RQ’s

Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits, Pods

, Seeds

Total Residues a

Watercress Bird 2.33 1.07 1.31 0.91 0.15

Mammal 0.95 0.44 0.53 0.37 0.06

Banana/ Plantains Bird 2.48 1.14 1.40 0.16 0.97

Mammal 1.01 0.46 0.57 0.40 0.06

a For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and

one non

- guideline study (MRID 46904507) for both the parent spirotetramat as well as for the total residues ( parent spi rotetramat, spirotetramat

- enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90% confidence limit of the mean half

- lives for the parent and total residue approaches are 3.3 and 5.3 days, respectively.



### It is important to note that these terrestrial risk concerns represent upper bound exposure

scenarios. Related to the risk concerns identified in Table 8 , these concerns for all taxa and all scenarios are removed when using the mean exposure values. Consequently, this difference highlights the concern that under some circumstances, the use of spirotetramat will pose no

concern either on an acute or chronic basis to mammals and birds. Under worst case conditions

that result in high levels of food contamination, however, both federally listed and non

- listed birds would be at risk from chronic exposure when they repeatedly consume food items that are contaminated by these two application scenarios. Federally listed and non

- lis ted mammals that consume primarily short grass food sources would be at risk as well from the proposed uses on banana and plantain due to chronic exposure . Based on the risk conclusions in the S3 New Chemical assessment for uses with similar application r ates, the proposed uses of globe

a rtichoke, c itrus, pome, bushberry/l ow g rowing b erry, c offee, p ineapple, p omegranate, and b ulb

v egetables also present a chronic risk to birds.

The proposed uses of spirotetramat do not present a risk of concern to terrest rial plants. Table 9 illustrates the RQ’s that result from the banana/plantain application scenario, which is the highest application rate of any use for spirotetramat. This application scencario therefore serves as a conservative scenario. In light of the lack of any exceedances of the plant LOCs in this scenario

, none of the proposed uses present a risk of concern to terrestrial plants from either run

- off or spray drift alone

.

Table 9 . RQs for non

- target plants inhabiting dry (upland) and semi

- aquatic (wetland) areas based on EECs of total spirotetramat (parent + degradates) residues on plants following the maximum exposure scenario of all crops (Banana/Plantain Scenario) using the Te rrPlant model (lbs a.i./A) for run

- off and spray drift alone. a

Application Method;

Rate Plant

Type Upland Wetland Drift Only

EEC

lb ai/A Non

Listed RQ b Listed

RQ c EEC

lb ai/A Non

Listed RQ b Listed

RQ c EEC

lb ai/A Non

Listed RQ Listed

RQ

Aerial Spray Application, Unincorp.;

0.25 lb Monocot 0.005 0.11 0.11 0.05 0.39 0.39 0.0625 0.21 <0.1

### 10

Table 9 . RQs for non

- target plants inhabiting dry (upland) and semi

- aquatic (wetland) areas based on EECs of total spirotetramat (parent + degradates) residues on plants following the maximum exposure scenario of all crops (Banana/Plantain Scenario) using the Te rrPlant model (lbs a.i./A) for run

- off and spray drift alone. a

Application Method;

Rate Plant

Type Upland Wetland Drift Only

EEC

lb ai/A Non

Listed RQ b Listed

RQ c EEC

lb ai/A Non

Listed RQ b Listed

RQ c EEC

lb ai/A Non

Listed RQ Listed

RQ

a.i./A

Dicot 0.11 0.11 0.39 0.39 <0.1 <0.1

a EECs and RQs are based on the most conservative modeling scenario possible for spirotetramat. Specifically, it was assumed t hat spirotetramat

was not ground incorporated, it was applied at the maximum single application rate for all uses (0.25 lb a.i/A) with aerial application methods (drift fraction = 0.05), and that the solubility is between 10 and 100 mg/L (solubility fraction=0.02).

b The most sensitive EC 25 value from seedling emergence studies used to derive RQs for non

- listed plants in upland and wetland areas was >0.16

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

c The most sensitive NOAEC value from seedling emergence studies used to derive RQs for listed plants in upland and wetland 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 used to derive RQs for non

- listed plants exposed to drift only were 0.06 and >0.16 lb a.i./A for monocots and dicots, respectively.

e The most sensitive NOAEC values from vegetative vigor studi es used to derive RQs for listed plants exposed to drift only were 0.02 and >0.16 lb a.i./A for monocots and dicots, respectively.



### Currently, the Agency does not quantitatively evaluate the risk to terrestrial invertebrates from pesticides for screening level assessments for non

- endangered species. However, risks to non

target listed insects cannot be precluded. Although the intrinsic hazard potential to bees based on

the acute oral and contact studies with adult honey bees appears to be low, brood feedin g tests with bees and acute toxicity contact studies with other non

- target insects (e.g. parasitoid wasps and predatory mites) suggest that there is potential for mortality primarily in pupae, 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 to adult honey bees

.

Higher tier studies to date for spirotetramat hav e been found to be insufficient to address the hazard of spirotetramat to bee brood and hive survival. The previous S3 New Use (D384525, dated 12/7/2010) provides a review of many of the higher tier studies submitted for spirotetramat. Two new Tier III f ull field studies have been submitted to the Agency since the

last S3 New Use , and EFED has reviewed these studies as well. The first tier III field study, MRID 48159802, evaluated the impact of spirotetramat to honey bee colonies under full field

conditi ons after two applications of 96 g a.i./ha/m canopy height (0.086 lb a.i./acre/m canopy height), which resulted in total applications of 278.4, 240.0, 230.4, and 172.8 g a.i./ha (0.25, 0.21, 0.21, and 0.15 lb a.i./acre). Note that the maximum seasonal app lication rate in the U.S. is

0.31 lb a.i./acre. This study is also classified as supplemental because it provides useful information on the residue levels. However, the study also has deficiencies related to the evaluation of the toxicity of the test com pound. Due to the lack of confirmation of hive exposure to spirotetramat residues, the likely alternative sources of forage, and the unequal fluctuations in the blossom abundance between and within treatment and control citrus groves over time

### 11

preclude th e ability to adequately evaluate the toxicity of spirotetramat residues on hive brood and hive stability.

Another study, MRID 48159801, is classified as supplemental. The study was conducted with one application of spirotetramat at 0.16 lbs ai/A to citru s at bloom and followed the condition of

both treated and control hives as they progressed through a season of commercial pollination. Note that this rate is equivalent to the maximum single application rate, but is half of the maximum seasonal applicatio n rate that may be applied to citrus in the U.S. Due to the many stresses placed on both the control and treated groups over the course of the commercial pollination, the study did not provide a useful evaluation of the toxicity of spirotetramat to honey bee colonies. However, the study provided useful information on the residue levels that would be encountered with an application to citrus at bloom. Yet there are uncertainties in the levels of residues as well. The study measured the parent and the eno l metabolites, but it did not measure

the keto

- hydroxy metabolite, which is also of concern to honeybees. Furthermore , EFED reviewed a protocol (D397343, 397373) for a field residue study for citrus that included a justification from Bayer CropScience (BC S) as to why they intended to only evaluate the parent

and the enol

- metabolite. From the data that they submitted, EFED was able to conclude that there remains insufficient justification for ruling out the keto

- hydroxy metabolite as a metabolite

of concer n. EFED also concluded that the enol

- glucoside metabolite should be measured in

future residue studies.

This previous review of spirotetramat residues (D 397343+) also highlighted an other uncertainty surrounding the residue data. The uncertainty relate s to the enol

- glucoside metabolite, which forms when plants metabolize the enol metabolite into the enol

- glucoside metabolite. The latter can then be metabolized back into the enol metabolite through biologically mediated processes in the digestive system of the rat. It is possible that enzymatic processes in the honey bee hive may

also effect the same transformation of the enol

- glucoside into the enol metabolite, the latter of which is of toxicological concern to the honey bee hive. Data presented in a field study on citrus (MRID48159802) that measured residues of the enol

- glucoside in citrus blossoms showed that

these residues continued to increase at the final sampling date of 15 days following the last application. These data suggest that while the p arent compound and primary metabolites of concern (enol and keto

- hydroxy) decrease in concentration after 7 days, the enol

- glucoside actually increases in concentration after 7 days with the potential to be transformed back into the enol metabolite through biologically mediated processes.

Based on the physical properties of spirotetramat and its systemic nature as well as the higher tier

studies , EFED identifies that the period of concern for spirotetramat applicati ons is the period before bloom, during bloom, and until petal fall is complete. In most cases for the proposed uses, the crops are not attractive to pollinators, are harvested before flowering, or are of relatively low acreage to be of concern to bees within the landscape. Uncertainties in exposure

to invertebrate pollinators related to the proposed uses remain primarily for the proposed tree crops and bushberry/low growing berry use due to the potential for carry

- over of residues from

one season to the next

. Therefore, non

- guideline residue data are needed that address es the systemic residues in th ese crop group s while a field study on the toxicity of spirotetramat (850.3040) is being placed in reserve pending the outcome of the residue studies. If the resi due

### 12

studies show that bees will continue to be exposed to sp irotetramat residues despite any potential

pr otective label language, then additional data may be needed

.

In addition, though bulb vegetables are of low attractiveness to pollinators, many bulb vegetables are commercially pollinated for seed production. These crops are sources of nectar for these commercially managed hives, which the bees will bring back to the hive to serve as a food source for the colony. An appropriate pre

- bloom application window may potentially support a reduction of risk concern for the colonies. Several studies submitted by Bayer CropScience support this conclusion. Study MRID 47563310 shows that total residues in nectar for Phacelia tanacetifolia begin to decline at 7 days after application, though total residues (parent + enol +

keto

- hydroxy) persist at least 10 days in nectar with a mean value of 0.22 mg/kg . A study with summer oilseed rape (MRID 47563311) also shows that spirotetramat total residues (parent +

enol + keto

- hydroxy) begin to decline at 7 days in nectar (mean = 0.04 mg/kg) , though the

decline is slow. In contrast, a study on residues in citrus nectar (MRID47563312) show that the

total residues were below the LOQ at 7 days following the last application, though this may be a function of a relatively high LOQ of 0.0545 mg a.i./kg. Similarly, when evaluating nectar

residues in melon (47563308) , residue levels were below the LOQ of 0.0545 mg/kg at even 5 days after treatment when spirotetramat was applied a t flowering. A field study with spirotetramat on citrus (MRID 48159801) revealed that total residues (parent + enol) in nectar remain fairly constant up to 7 days after application when made at bloom with mea n concentrations of 0.01 mg /kg. Another field study with spirotetramat on citrus (MRID 47563304) revealed that concentrations were less than 0.01 mg/kg total residues (parent + enol) at 7 days and beyond the last application. Given all of this data, it appears that total residues (parent + enol + keto

- hydroxy) of spirotetramat in nectar remain relatively low compared to pollen and decline after 7 days following application , but the decline occurs slowly and with some plants retaining mean total residue levels as high as 0.22 mg/kg

. However, uncertainty

remains related to the relationship for the time between application and flowering and the residue

levels in the nectar.

For the proposed use, there is therefore uncertainty related to the bulb vegetables grown specifically for seed production with pre

- bloom applications of spirotetramat

. With that in mind, the currently available data do not provide enough information on pre

- bloom applications to address the efficacy of pre

- bloom use patterns or restrictions to eliminate exposure t o invertebrate pollinators. There is also insufficient toxicity data to establish a toxic threshold. In order to address concerns related to the commercially managed hives that are used to pollinate these specific crops, data needs would include residue levels in these bulb vegetables in the flower nectar with the expected application dates of spirotetramat at the maximum application rate and the minimum appl ication interval. Information on the potential transformation of the

enol

- glucoside by honey bees would be highly beneficial as well. Finally, toxicity data to bee brood at the levels expected in these bulb vegetables. However, it is also important to note that these bulb vegetables grown for seed production would comprise a relatively low total acr eage.

Even with protective label language that may limit applications to after petal fall

, other concerns

remain for spray drift of spirotetramat to blooming plants adjacent to the site of application that may be contaminated , regardless of the crop . T hese blooming plants may serve as a food source to bees. The absence of data on effects to invertebrate pollinators from spray drift to adjacent

### 13

blooming plants is an uncertainty, and so efforts should be made to minimize drift to adjacent

areas with bloo ming flowers.

For citrus, EFED suggests that the original label statement, “ Do not apply this product within 10 days prior to bloom, during bloom, or until petal fall is compl ete”, may be used. Data should be submitted to EPA to confirm and quantify levels of residues in citrus leaves, pollen, and nectar after applications at different times before bloom. The purpose of the study is to evaluate residue levels at 10 days before bloom and prior to 10 days be fore bloom in order to better evaluate exposure to bees, and, if necessary, to revise the appropriate pre

- bloom “window” necessary to protect pollinators. EFED has previously commented on a protocol for evaluating residues in citrus (D397343, 397373), bu t this data has not yet been submitted to the Agency.

### 14



## Appendix A. Use Information for Spirotetramat New Uses 2012

Table A

- 1 is a summary of all agricultural use patterns for spirotetramat in the l abels for BYI 8330 150 OD Insecticide (oil dispersion

, Reg. No. 264

- 1051 )

, MOVENTO ® 

### SC (suspension

concentrate , Reg. No. 264

- 1050 ) , and the ULTOR® (suspension concentrate, Reg. No. 264

- 1075)

.

Table A

- 1 . Summary use information for spirotetramat based on labels for BYI 8330 150 OD Insecticide), MOVENTO ® 

### and ULTOR ®



### . The new uses are shaded yellow

.

USE SINGLE

APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN

APP S . (days) APP.

METHOD PHI

(days)

Soybean 0.08 2 0.16 7 G*, A 21

Tropical Fruits (acerola, avocado, black sapote, canistel, feijoa, guava, longan, lychee, mamey sapote, mango, papaya, passionfruit, persimmon, pulasan, rambutan, sapodilla, Spanish lime, star apple, starfruit, wax jambo, white sapote

, jaboticaba ) 0.16 3 0 .40 14 G*, A,

Airblast 1

Legume Vegetables (Crop Group 6, except dry soybean) ( Edible Podded and Succulent

Shelled Pea and Bean and Dried

Shelled Pea and Bean

Bean ( Lupinus spp., including grain lupin, sweet lupin, white lupin, and white sweet lupin)

Bean ( Phaseolus spp., including field bean, kidney bean, lima bean, navy bean, pinto bean, runner bean, snap bean, tepary bean, wax bean)

Bean ( Vigna spp., including adzuki bean, asparagus bean, blackeyed pea, catjang, Chinese longbean, cowpea, Crowder pea , moth bean, mung bean, rice bean, Southern pea, urd bean, yardlong bean)

Pea ( Pisum spp. including dwarf pea, edible

- pod pea, English pea, field pea, garden pea, green pea, snow pea, sugar snap pea)

Other Beans and Peas (Broad bean (fava), Chickpea (garba nzo bean), Guar, Jackbean, Lablab bean (hyacinth bean), Lentil, Pigeon pea, soybean (immature seed), Sword bean) 0.08 2 0.16 7 G*, A, C 1 edible podded,

succulent

beans and

peas;

7 dry

shelled

beans and

peas

Globe artichoke 0.12 ~5 0.5 7 G, A, C 3

### 15

Table A

- 1 . Summary use information for spirotetramat based on labels for BYI 8330 150 OD Insecticide), MOVENTO ® 

### and ULTOR ®



### . The new uses are shaded yellow

.

USE SINGLE

APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN

APP S . (days) APP.

METHOD PHI

(days)

Citrus Fruit (Crop Group 10

- 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, Australian lime (desert, finger , and round), Brown River finger lime, Japanese summer grapefruit, Mediterranean mandarin, Mount White lime, New Guinea wild lime, Russell River lime, s weet lime, Tachibana orange, T ahiti lime, Trifoliate orange, u niq fruit, including cultivars, varieties and/or hybrids of these commodities ) 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, hardy kiwifruit) 0.13 2 0.2 30 G*, A,

Airblast 7

Pome Fruit (Crop Group 11

- 10

, including apple, crabapple, loquat, mayhaw, pear, Asian pear, quince

, azarole, Chinese quince, Japanese quince, medlar, tejocote , hybrids,

cultivars and/or varieties of these ) 0.14 3 0.4 14 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 or hazelnut, hickory nut, macadamia nut or bush nut, pecan, pistachio,

black walnut

, and English or Persian walnut) 0.14 3 0.34 14 G*, A,

Airblast 7

Hops 0.10 2 0.2 14 G*, A,

Airblast 7

Christmas Tree Plantations 0.16 2 0.32 14 G*, A,

Airblast N/A

### 16

Table A

- 1 . Summary use information for spirotetramat based on labels for BYI 8330 150 OD Insecticide), MOVENTO ® 

### and ULTOR ®



### . The new uses are shaded yellow

.

USE SINGLE

APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN

APP S . (days) APP.

METHOD PHI

(days)

Fruiting Vegetables (Crop Group 8

- 10 including eggplant, groundcherry, okra, pepinos, bell

and non

- bell pepper ( cayenne, chili pepper, habanero, jalapeno, pablano, pimento and serranero ) , tomatillo

, tomato

, African eggplant, Bush

tomato, cocona, currant tomato, garden huckleberry, goji berry, martynia, naranjilla, pea eggplant, roselle, scarlet eggplant, sunberry, tree tomato, including varieties and/ or hybrids of these commodities ) 0.08 2 0.16 7 G, A, C 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

- hea d and leaf, orach, parsley, garden and winter purslane, radicchio or red chicory, rhubarb, spinach

- various kinds, Swiss chard

, taro leaves ) 0.08 2 0.16 7 G, A, C 3

Brassica (Cole) Leafy Vegetables (Crop Group 5 including broccoli, broccoli raab

, Brussels sprouts, cabbage, cauliflower, cavalo broccolo, Chinese broccoli, Chinese cabbage (bok choy), Chinese cabbage (napa)

, Chinese mustard cabbage (gai choy) , collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, rape greens) 0.08 2 0.1 6 7 G, A, C 1

Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C including arracacha, arrowroot, Chinese and Jerusalem artichoke, edible canna, bitter and sweet cassava, chayote

- root, chufa, dasheen or taro, ginger, leren

, potato, sweet potato, tanier, turmeric, yam bean, true yam) 0.08 2 0.16 7 G, A, C 7

### 17

Table A

- 1 . Summary use information for spirotetramat based on labels for BYI 8330 150 OD Insecticide), MOVENTO ® 

### and ULTOR ®



### . The new uses are shaded yellow

.

USE SINGLE

APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN

APP S . (days) APP.

METHOD PHI

(days)

Bushberry and Low Growing Berry Subgroups ( Crop Subgroups 13

- 07B and 13

- 07H including a ronia berry, bearberry, bilberry, blueberry (highbush and lowbush), Chilean guava, cloudberry, cranberry , currant (black, buffalo, native, and red), elderberry, European barberry, gooseberry, edible honeysuckle, jostaberry, Juneberry, muntries, lingonberry , Partridgeberry, salal, sea buckthorn, and cultivars, varieties, and/or hybrids of these) 0.16 3 0.47 7 G*, A,

Airblast 7

Watercress 0.2 2 0.4 7 G, A, C 3

Banana and Plantains 0.25 5 1.25 14 G*, A,

Airblast 1

Coffee 0.16 3 0.47 21 G*, A,

Airblast 14

Pineapple 0.16 2 0.32 14 G*, A,

Airblast 1

Pomegranate 0.16 2 0.32 14 G*, A,

Airblast 1

Bulb Vegetables

Crops of Crop Subgroup 3

- 07A
(i ncluding: d aylily (bulb), f ritillaria (bulb), g arlic ( bulbs of common,

great

- headed, s erpent), l ily (bulb),

o n ion (bulbs of common, Chinese,

p earl, potato onion), s hallot (bulb), plus cultivars, varieties, and/or hybrids of these );

Crops of Crop Subgroup 3

- 07B

, (i ncluding: Chinese chive (fresh leaves), c hive (fresh leaves), e legans hosta, f ritillaria (leaves), k

urrat

, l eek (Allium porrum, Lady’s, w ild),

o nion (Beltsville bunching, fresh, green, macrostem, tree [tops], w elsh [tops]), s hallot (fresh leaves), plus cultivars, varieties, and/or hybrids of

these ) 0.08 2 0.16 7 G, A, C 3 for CS

3

- 07A;

7 for CS

3

- 07B

*High air velocity, low volume or air curtain sprayers; G = ground; A = aerial; C = chemigation

### 18



## Appendix B . Aquatic Exposure Assessment for the New Uses of Spirotetramat

2012

I. Conventional Agricultural Crops

Approach to Model Conventional Crops

For agricultural uses, exposure concentrations for aquatic ecosystems assessments were estimated based on EFED’s Tier II linked 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/index.htm , accessed 07/20/2012), was used to facilitate inputting chemical and use specific parameters into the appropriate PRZM input files (inp) and EXAMS chemical files. The Pesticide Root Zone Model (PRZM v. 3.12.2, May 12, 2005) field or orchard crop scenario is the basic file which describes the local or regional climatological information, soil hydrology, soil characteristics, crop characteristics, and the pesticide p roperties necessary to determine pesticide loadings to ground or surface water. This basic file constitutes the first part of the “exposure scenario.” It simulates the processes in the agricultural field, such as runoff and erosion, on a daily time step. The runoff and erosion flux output data from PRZM are used as chemical loadings to the Exposure Analysis Modeling System (EXAMS v. 2.98.04.06, April 25, 2005), which simulates surface water, in order to predict the estimated exposure concentrations (EECs ). EECs for ecological risk assessment were determined using a pond modeling scenario which describes a standard scenario for the EXAMS component of the modeling exercise (EXAMS Mississippi pond). Tables B 1

- 1 and B 1

- 2 summarize the input parameters for s pirotetramat and for the total residues of concern (total toxic residues or TTR). The estimated exposure concentrations are summarized in Tables B 1

- 3

.

Selection of PRZM scenarios The PRZM scenarios selected for modeling were CA row crops, OR berries, PR coffee and FL citrus. These crops were selected to represent artichoke, bushberries and low growing berries, coffee, and bananas and plantains, respectively. An effort was made to model representative crops among the crops in the label with the highest s easonal application rate . Information from the Census of Agriculture shows that by far California is the greatest producer of artichokes. Other states with reported production are Arizona, Hawaii, Oregon, Texas and Washington. The CA row crops scenario was considered the most suitable to represent the artichoke crop. OR was among the top five producers of blueberries in 2010 and 2011 and it had the third highest harvested area in 2010 and 2011 (refer to Tables 02 and 06 of the USDA data at http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1765 (accessed 07/20/2012). Even though the OR berries scenario was initially intended for organophosphat e assessments, it was regarded as a good representative scenario for bushberries and low growing berries. The PR coffee scenario was used to represent the intended crop. Only two US states and territories appear to produce coffee (according to the 2007 C ensus of Agriculture, 37,422 acres in PR and 7,891 acres in HI). Finally, there was no PRZM/EXAMS scenario for bananas and plantains, which were the crops with the highest application rate. According to the Census of Agriculture, in 2009 and 2010, 1,100 acres were harvested (bananas) in HI. Meanwhile, in PR 17,500 acres were planted to plantains and 6

, 810 acres were planted to bananas in 2007. In order to appropriately represent this crop that may be planted year round, the FL citrus scenario was

### 19

utilized. It has a south FL climate (West Palm Beach) and well drained sandy soil. Since the EECs were well below the LOCs, runs with additional weather stations were not deemed necessary. It is noted that the FL citrus scenario was used in a past asses sment to represent the intended crop ( i.e. , citrus crops). In that instance in contrast, the application rate was much smaller (0.16 lb a.i./A, two applications at 21 day intervals and applications made in the month of November).

Input Parameters

Maximum seasonal application rates were utilized, with the minimum interval between applications. There is no usage data because these are new crops for spirotetramat. It is unknown if these rates will be representative of the typical application rates; neverth eless, they represent a conservative estimate. Applications were assumed to occur 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). For bananas and plantains, applications were assumed to occur in the summer. For all the crops and crop scenarios, runs were performed for the parent compound, spirotetramat. For the crop that yielded the highest estimated exposure concentrations ( EECs ) , an additional run was performed for the total toxic residues (spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy + non

- extracted residues)

, consistent with previous assessments

.

Only the aerial method of application w as modeled. For spirotetram at ( Table B I

- 1 ), the average
K d 

### was a better descriptor of the mobility of the parent ( i.e. , the coefficient of variation is smaller

for K d 

### than for K OC 

### ). The aerobic and anaerobic aquatic metabolism half

- lives were not adjusted for hydrolysis. The aerob ic 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 actual value was 0.26 days when adjusted for temperature at 25 0 C). The average pH of the water in the studies ranged from 6.7

– 7.3. The anaerobic aquatic metabolism value is 2.8 days and the pH range in the water phase was 7.7

- 7.9, increasing to 8.2

- 8.3 by the end of the study. Since the hydrolysis is dependent upon the pH and the reaction is faster at pH 9 (0.32 days at 25°C), the h ydrolysis may have played a role in the degradation of spirotetramat. However, the extent of such reaction is unknown. The actual input parameter, when adjusted for temperature at 25 0 C is 0.70 days x 3 (factoring that there is only one value) = 2.1 days.

As indicated above, one PRZM/EXAMS run was set for the total residues of spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy + un

- or non

- extracted residues, which were considered of concern ( Table B I

- 2 ). The soils and sediments may also be r epositories of toxic residues since high levels of non

- extracted residues were observed in metabolism studies (up to 60% of AR). The total residues of spirotetramat, spirotetramat

- enol, spirotetramat

- ketohydroxy

and non

- extracted residues are much more pe rsistent than the parent or its major metabolites

considered 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 (prior to adjusting to temperature of 25 0 C), were estimated from the aerobic aquatic metabolism studies for spirotetramat + spirotetramat

- enol + spirotetramat

ketohydroxy + non

- extracted residues. The registrant indicated that the non

- extracted residues

were immobile and not accessible ; this issue is explored with more detail later in this appendix

.

### 20

A conservative approach was taken and for the half

- life calculation, it was assumed that the non

ex tracted residues were persistent compounds.

The crop selected for modeling the total toxic residues (TTR), was the FL citrus , which

represent s bananas and plantains, with the highest seasonal application rate and the most conservative application method a nd the highest EECs . For the total residues (TTR) , 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 appears to be the most stable of the chemicals of concern. Also, f or the total residues, the representative half

- lives were obtained by adding the values of the concentrations of the parent, spirotetramat

- enol, spirotetramat

ketohydroxy and non

- extracted residues, and calculating the ha lf

- life of the decay of their sum

. 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 TTR were stable ( e.g. spirotetramat

- enol was

found to be stable to hydrolys is, therefore, the TTR were considered to be stable to that route of degradation). The aerobic soil metabolism input parameter was estimated for the total residues of spirotetramat

- enol + spirotetramat

- ketohydroxy + non

- extracted residues (from the aerobi c soil metabolism study conducted with spirotetramat

- enol). Similarly, the aerobic aquatic metabolism input parameter was estimated for the total residues of spirotetramat + spirotetramat

enol + spirotetramat

- ketohydroxy + non

- extracted residues. The wat er solubility of spirotetramat

- ketohydroxy was considered the most adequate input parameter for the TTR , since it is the last degradate in the pattern of formation and decay. Since spirotetramat amide was a minor degradate, it was not considered in the mo deling

. 1



### There is a relatively high degree of certainty on the input parameters for the runs for the parent only. The database was substantially complete. In some instances multiple values were available, from which the input values were derived ( e.g. f or aerobic aquatic metabolism

– two
half

- lives were available, and for aerobic soil metabolism

– four half

- lives were available). In other instances, the available value was multiplied by three to account for the uncertainty due to

the fact that there was only one value. ( e.g. anaerobic aquatic metabolism

– 8.4 days, from 3 x 2.8 days , subsequently corrected for temperature ). For the aqueous photolysis, the single value

available was entered

– 14.4 days. For the parent, there are various routes of dissip ation. This is reflected in the input parameters in PRZM/EXAMS (input values 0.298 days for aerobic soil metabolism, 0.2676 days for aerobic aquatic metabolism, 2.1 days for anaerobic aquatic metabolism, 13.1 days for hydrolysis, and 14.4 days for aqueous photolysis). Note that the aerobic aquatic metabolism and anaerobic aquatic metabolism input values were adjusted for temperature at 25 0 C. On the other hand, the total residues (spirotetramat + spirotetramat

- enol + spirotetramat

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

metabolism and 140 .9 days for aerobic aquatic metabolism). Table B I

- 1 provides the input parameters for the parent compound.

1 The registrant submitted their own modeling calculations including the degradate; however, EFED did not consider it necessary.

### 21

Table B I

- 1 . Input Parameters for PRZM/ EXAMS for the Estimation of the EECs of Spirotetramat 

### Parameter (units) Value(s) Sources Comments / Other

Output File Name SPIROTET

--- --- Chemical Name Spirotetramat Label Proposed labels
Crop Name s CA row crops

OR berries

PR coffee

FL citrus Label Proposed labels: CA row crops represents globe artichoke while OR berries represents

bushberries and low growing berries and FL citrus is used as a surrogate for bananas Application Rate Crop/ lb a.i./A/ kg a.i./ha CA row crops/ 0.10/ 0.1121

OR berries/ 0.16/ 0.1793

PR coffee/ 0.16/ 0.1793

FL citrus/ 0.25/ 0.2808 Label For globe artichoke, the single max application rate is 0.12. In order to accommodate the max seasonal rate, five applications at 0.10 lb a.i./A were assumed.

Day of Application (day

- month) /

pre

- harvest interval CA row crops 10

- 02

OR berries 10

- 05

PR coffee 01

- 06

FL citrus 01

- 05 PHI (days) : CA row crops 3

OR berries 7

PR coffee 14

FL citrus 1 Estimated from metadata file & labels. Crop emergence/ maturity/ harvest day

- mo : CA row crops 01

- 01/ 01

- 04/ 08

- 04

OR berries 01

- 04/ 30

- 07/ 30

- 07

PR coffee 01

- 01/ 02

- 01/ 31

- 12

FL citrus 01

- 01/ 02

- 01/ 31

- 12

Maximum Number of Applications Allowed at the Maximum Application Rate CA row crops 5

OR berries 3

PR coffee 3

FL citrus 5 Label Proposed labels

Minimum Interval between Applications (days) CA row crops 7

OR berries 7

PR coffee 21

FL citrus 14 Label Proposed labels

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 Input Parameter

Guidance 1, pesticide remaining on foliage is converted to surface application to the top soil layer

DEPI = Incorporation Depth (cm) 0.0 Label Proposed labels

K d ( m L/g ) 4.39 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

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

EXAMS

. 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 sandy loam ; t 1/2 = 0.30 days, sandy loam ; t 1/2 = 0.24 days, silty loam ; t 1/2 = 0.26 days, silt ; t 1/2 = 0.09 days ) (DFOP best

fit kine tics). Method of Application A erial Label Proposed labels
Buffer Zone (ft.) N/A Label Proposed labels Application Efficiency (fraction) 0.95 for aerial application

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

--- EFED guidance Solubility in Water (ppm) 33.5 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

and Behaviour EFED guidance

Aerobic Aquatic Metabolism (days) 0.2676 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 at 20 0 C ( loam sediment; t 1/2 =1.06 days, loamy sand sediment; t 1/2 =1.05 days) (SFO kinetics). Adjusted values at 25 0 C: 0.265 days and 0.2625 days, mean 0.26375,

std. dev. 0.00178 days, t 90,n

- 1 = 3.078. Anaerobic Aquatic Metabolism (days) 2.1 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 s ingle value (SFO kinetics). Since the value was

obtained at 20 0 C, it was adjust ed to 25 0 C (0.70 days x 3 = 2.1 days). Hydrolysis at pH 7 half

- life (days) 13.1 OECD Monograph

Annex B. EFED guidance (SFO kinetics).

### 22

Table B I

- 1 . Input Parameters for PRZM/ EXAMS for the Estimation of the EECs of Spirotetramat 

### Parameter (units) Value(s) Sources Comments / Other

Spirotetramat. B.8 Fate

and Behaviour 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

Annex B. Spirotetramat. B.8 Fate

and Behaviour ---

Henry’s Law Constant ( A tm

- 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 PLDKRT, Decay rate on foliage 0

--- EFED guidance
PLVKRT, Volatilization rate from foliage 0

--- EFED guidance

UPTKF, Uptake factor 0

--- EFED guidance

Write Benthic Pore Water

Concentrations? Yes

--- For information only



### Table B I

- 2 provides the input parameters for the TTRs.

Table B I

- 2. Input Parameters for PRZM/EXAMS for the Estimation of the EECs of Spirotetramat + Degradates (Total Residues : Spirotetramat + Spirotetramat

- enol + Spirotetramat

- ketohydroxy + Non

Extracted Residues ) for a Representative Crop With the Highest EECs: FL citrus (bananas and plantains)
Parameter (units) Value ( s ) S ources C omments
Output File Name SPIROTET

--- --- Chemical Name Spirotetramat Label Proposed labels
Crop Name s FL citrus Label Proposed labels (represents bananas and plantains

– crop with the highest EECs using the parent only. Application Rate Crop/ lb a.i./A/ kg a.i./ha

FL citrus/ 0.25/ 0.2808 Label Proposed labels

Day of Application (day

- month) /

pre

- harvest interval

FL citrus 01

- 05 PHI (days) : FL citrus 1 Estimated from metadata file & labels. Crop emergence/ maturity/ harvest day

- mo : FL citrus 01

- 01/ 02

- 01/ 31

- 12

Maximum Number of Applications Allowed at the Maximum Application Rate FL citrus 5 Label Proposed labels

Minimum Interval between Applications (days) FL citrus 14 Label Proposed labels

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 Input Parameter

Guidance 1, pesticide remaining on foliage is converted to surface application to the top soil layer

DEPI = Incorporation Depth (cm) 0.0 Label Proposed labels

K OC ( m L/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. The K OC value represents better the mobility of spirotetramat

ketohydroxy , the terminal degradate and the

### 23

Table B I

- 2. Input Parameters for PRZM/EXAMS for the Estimation of the EECs of Spirotetramat + Degradates (Total Residues : Spirotetramat + Spirotetramat

- enol + Spirotetramat

- ketohydroxy + Non

Extracted Residues ) for a Representative Crop With the Highest EECs: FL citrus (bananas and plantains)
Parameter (units) Value ( s ) S ources C omments

most stable (relative standard deviation is smaller).

Aerobic Soil Metabo lism (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 possible significant figures used , use of log

- linear 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 A erial Label Proposed labels
Buffer Zone (ft.) N/A Label Proposed labels Application Efficiency (fraction) 0.95 for aerial application

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

--- EFED guidance Solubility in Water (ppm) 228 OECD Monograph

Annex B. Spirotetramat. B.8 Fate

and Behaviour EFED guidance

Aerobic Aquatic Metabolism (days) Total Residues 140.9 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 four half

life values 385.00 ; 693.00, 141.43, 256.67 days at 20 0 C, which are adjust ed to 25 0 C: 96.25, 173.25, 35.36, and 64.17 days; std. dev = 59.447 days, mean = 92.26 days ( use d of log

- linear para meters). 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.

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 ( A tm

- 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 pon d scenario, as opposed to index reservoir. Field Size EPA Pond

--- Runoff none

--- --- FEXTRC, Foliar extraction 0.5

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

--- EFED guidance
PLVKRT, Volatilization rate from foliage 0

--- EFED guidance

UPTKF, Uptake factor 0

--- EFED guidance

Write Benthic Pore Water

Concentrations? Yes

--- For information only

### 24

The modeling results using PRZM/EXAMS are presented in Table B I

- 3

,

Table B I

- 3. Estimated exposure concentrations of spirotetramat (parent only) in the water column. Artichoke (represented by CA row crops), bushberries and low growing berries (represented by OR berries), bananas (represented by FL citrus), and coffee (PR coffee ) calculated with PRZM/ EXAMS. 2



### Crop Scenario/App. rate/No. Apps/Int. Between Apps. 

### Peak/ppb 21

- day/ppb 60

- day/ppb CA row crops

0.10/ 5/ 7 0.284 0.0464 0.0265

OR berry

0.16/ 3/ 7 0.449 0.0658 0.0230

PR coffee

0.16/ 3/ 21 0.491 0.0197 0.0155

FL citrus

0.25/ 5/ 14 1.46 0.0622 0.0462

TTR = total toxic residues = spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy + NERs



### For the parent spirotetramat, the FL citrus scenario yielded peak EECs that were higher by a

factor of around 3. These results are consistent with the higher application rate for bananas and plantains. Since the chemical is labile, the 21

- day and 60

- day EECs were much lower than the peak EECs. It is noted that this pattern is not followed by the NC a pples (previously assessed crop), since when it was modeled, the guidance for temperature adjustment for the aerobic and anaerobic aquatic metabolism input values had not been implemented. Since these studies were

conducted at 20 0 C, the input half

- lives, adjusted to 25 0 C are lower than in the previous assessment and as a consequence, the long term values decrease faster than previously modeled.

In contrast, because the TTR are relatively persistent to most of the routes of degradation and metabolism, the EECs do not decrease as quickly as for the parent only (see Table B I

- 4 ).

Table B I

- 4. Estimated exposure concentrations of spirotetramat TTR in the water column calculated with PRZM/ EXAMS. Bananas (represented by FL citrus), is the scenario that yielded the highest EECs when modeling the parent only (see previous table). 3



### Crop Scenario/App. rate/No. Apps/Int. Between Apps. 

### Peak/ppb 21

- day/ppb 60

- day/ppb

FL citrus TTR

0.25/ 5/ 14 19.6 18.7 17.5

2 All values are rounded to t hree significant figures.

3 All values are rounded to three significant figures.

### 25



## II. Aquatic Crops

Approach to Modeling Aquatic Crops

Watercress Watercress is typically grown in clean, flowing water, 2 to 3 inches deep. 4 

### The Agency does not currently have a methodology for exposure assessment for crops cultivated in flowing water,

such as watercress. The Tier 1 Rice model v.1.0 5 

### was, therefore, used as the basis of the assessment of surface waters, and the results were characterized to reflect differences between the capabilities of this model and the watercress cultivation practices

. Wa tercress is a very minor use (<700 acres were harvested in 2002 and 2007 across the U.S. and there were <65 farms, according to the U.S. Census of Agriculture, National Agricultural Statistics Service, U.S. Department of Agriculture) . Based on a previous review, and according to information provided by the registrant and IR

- 4, it appears that according to agricultural practices, watercress is grown in a bed of water which drains to a ditch which is constantly recirculated. 6 

### (In Florida, as per the Florida Department of Agricultur e and Consumer Services Section 18 request, f ield plots are 4

- acres sized each and laser leveled. R efer also to the Section 18 for the use on watercress in Florida, DP Barcode D399575, which is dated 04/05/2012

. ) The circulation of water is stopped

24 ho urs before and is started 24 hours after chemical applications.

EFED is concerned primarily about the total toxic residues (TTR), as opposed to the parent

chemical per sé , or the individual metabolites (spirotetramat

- enol

, spirotetramat

- ketohydroxy

and no n

- extracted residues ), from discharge towards adjacent bodies of water likely to occur at the end of the season. EFED does not have a standard model for applications on watercress. As indicated above, i n order to represent the proposed use on watercress, the Tier 1 Rice model v.1.0 was provisionally used (USEPA 2007 , see footnote ). Individual metabolites were not modeled because this would double count mass of pesticide and transformation products in this particular model. The simplified equation for th e Tier 1 Rice Model v.1.0 is as follows:

Equation B 1

Where:

C

w 

### = E EC = water concentration [μg/L or ppb]

m ai 

### ' = mass applied per unit area [kg/ha] ( i.e. , the seasonal application rate)

K d 

### = water

- sediment partitioning coefficient [L/kg]

4 E.g. , see http://www.naturesherbal.com/Watercress.htm ; see also http://www.bwqualitygrowers.com/ourfarms.aspx (accessed 07/12/2012)

5 U.S. Environmental Protection Agency 2007. Guidance for Tier I Estimation of Aqueous Pesticide Concentrations in Rice Paddies ( dated 05/08/2007)

. Available at http://www.epa.gov/oppefed1/models/water/rice_tier_i.htm (accessed 07/17/2012).

6 Per information provided by the registrant in email from John Bell ( Product Development Manager, Bayer CropScience ) to Laura Nollen (C hemical Review Manager , R egistration Division ), dated 07/16/2012.

### 26

For the applications of spirotetramat on watercress, the E EC expression is based on spirotetramat

- ketohydroxy, which is the last and more persistent metabolite of the degradation pathwa y:

Spirotetramat  Spirotetramat

- enol  Spirotetramat

- ketohydroxy (  NERs)

For spirotetramat, the calculation is therefore:

Where the input parameters selected for the model and their justifica tion and sources are specified in Table B I I

- 1

.

Table B I I

- 1. Tier I Rice Model v1.0 input parameters for spirotetramat use on watercress

Input

Parameter Value Justification Source

Application Rate ( m ai ' ) 0.44832 0.20 lb a.i ./A/application x 2 applications = 0.4 lb a.i./A (x 1.1208 Kg·A/ha·lb) = 0.44832 kg a.i./ha Proposed spirotetramat

labels

Soil

- to

- Water

Partition Coefficient (K d ) 0.6532 K d = Mean K OC (65.32 L/Kg

oc ) x 1% organic carbon content = 0.6532 L/kg for the total spirotetramat

residues 1 OECD Monograph Annex B. Spirotetramat. B.8 Fate

and Behaviour

1. The representative partition coefficient used is the one for spirotetramat

- ketohydroxy, which is the last metabolite in the degradation sequence and for which the K OC model is more suitable than the K d model ( i.e. , the coefficient of variation is smaller).



### Assumptions of the Tier 1 Rice Model v.1.0 ( Provisional

ly Used for Watercress )

Most of the assumptions used in the Tier 1 Rice Model v.1.0 model help ensure that the outputs are protective of most environments associated with rice agriculture (noted though, that it is provisionally being used to represent the uses on watercress). Rice cultivation differs from

watercress in that for the latter the water is constant ly flowing while for rice, the field is flooded. The model assumptions include the following (see USEPA 2007 , referenced in a footnote, for parameterization information and further details):

1. Movement of pesticide on suspended sediment is not considered ( while for this use, water is constantly circulated except when pesticides are applied; the water circulation may promote pesticide movement).

2. Degradation does not occur (notwithstanding, the TTR are relatively persistent to aerobic aquatic metabolism and m oderately persistent to aerobic soil metabolism).

3. Volatilization and other dissipation processes are not considered (for spirotetramat, the vapor pressure and Henry’s Law Constant are low, indicating a low potential for volatilization, but other dissipatio n processes like degradation and metabolism are not considered).

4. The partitioning to sediment is instantaneous.

### 27

5. Water is available for non

- target animal exposure instantaneously (because the chemical is likely circulated, it appears that the water would be discharged into adjacent bodies of water and would be of concern primarily at the end of the season).

6. Water column depth is 10 cm. (Based upon unofficial data, it appears that actual depth is in the range of 1 to 3 inches or around 2.5 to ~8 cm). As per the registrant, chemical applications occur 24 hours after water circulation is stopped and water circulation is restarted 24 hours after application.)

7. Sediment depth is 1 cm.

8. All pore space is saturated with water.

9. Organic carbon fraction is 0.01 ( i.e.

, 1% OC).

10. Bulk density is 1300 kg/m 3



### . 11. Grain density is 2650 kg/m 3



### .

The aerobic soil half

- life for the TTR is on the order of 222.3 days and their partitioning is not too strong with a K OC 

### of 65.32 L/Kg OC 

### (mobile according to FAO mobility classification, FAO

2000 7 

### , using spirotetramat

- ketohydroxy as the representative chemical). The aerobic soil

metabolism half

- life for spirotetramat TTR is 140.9 days. It is noted that neither the degradation of the pesticide nor the mass transfer from the aqueous phase to the sediment are considered in this conceptualization, which greatly simplifies the model. The absence of degradation adds conservatism to the model ( i.e. , estimated concentrations should be higher than those usually found in rice paddies, considered repr esentative of use on watercress). The absence of mass transfer processes can either add or reduce conservatism depending on numerous conditions such as whether the pesticide is soil or water applied and whether actual degradation occurs preferentially in the sediment or the water compartment; however, consideration of this parameter is a refinement beyond a Tier 1 conceptualization. Spirotetramat is actually foliarly applied and the chemicals (spirotetramat, spirotetramat

- enol and spirotetramat

- ketohydrox y) do not readily bind to bottom sediment. The nature of the non

- extracted residues is uncertain.

Refinements to the Tier 1 Rice Model v.1.0 In order to refine the results, and due to expected exceedances of the acute LOCs, the rice model, provisionally used for this crop, was modified in order to accommodate degradation and/or metabolism. Thus, the aerobic soil and the aerobic aquatic metabolism were incorporated. The former is assumed to occur only for a period of 1 day for each application (prior to flooding), and the latter is assumed to occur from the time of the last application. The results of the modeling watercress are presented in Table B II

- 2 a

.

Cranberry For cranberry, similar refinements over the provisional Tier I Rice Model v.1.0 were per formed. Cranberry bogs are not typically flooded until the night before harvesting. According to the Cranberry Institute site 8



### , “[t]he plant produces stolons (horizontal stems) up to 6 feet (2 m) long. Short vertical branches, or uprights, 2 to 8 inches (5 to 20 cm) in height, grow from buds on the

7 Food and Agriculture Organization of the United Nations. FAO PESTICIDE DISPOSAL SERIES 8. Assessing

Soil Contamination: A Reference Manual. Appendix 2. Parameters of pesticides that influence processes in the soil. Editorial Group, FAO Information Division: Rome, 2000. http://www.fao.org/DOCREP/003/X2570E/ X2570E00.htm (accessed 07/17/2012).

8 Available at http://www.cranberryinstitute.org/about_cranberry.htm (accessed 07/25/2012).

### 28

stolons and these can be either vegetative or fruiting.” When cranberry fields are flooded, the water depth is typically 12

- 18 in (0.305

- 0.457 m) to cover the plants with water above the vine.

The lowest val ue was selected, since it is more conservative. The results of the modeling cranberries are presented in Table B II

- 2 b

.

Modeling Results Using the Modified Tier 1 Rice Model v.1.0

For both, watercress and cranberry, the parent only was modeled. Furthermore, the total residues of spirotetramat ( spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy + NERs) were modeled. Finally, for characterization purposes, the total residues, excluding the NERs were calculated. In all instances, appli cations were assumed to occur 1 day pre

- flood. According to the label, the proposed pre

- harvest interval is 7 days. It is noted that the registrant indicated previously that for cranberry , they could p ut restrictions in their labels , limiting application s to a

pre

- flooding interval of 30 days. Therefore, the EFED evaluated for additional characterization, the total residues with a period of 30 days pre

- flood.

Table B II

- 2a. Estimated exposure concentrations of spirotetramat (ppb) in the

water column. W atercress use, calculated with the modified Tier 1 Rice model

v.1.0. 9



### Crop Scenario/App. rate/No. Apps/Int. Between Apps. 

### Peak/ppb 21

- day/ppb 60

- day/ppb Spirotetramat only

0.2/ 2/ 7 38.6 1.99 0.695

TTR + NERs

0.2/ 2/ 7 393 381 359

TTR (excluding the NERs)

0.2/ 2/ 7 373 361 338

TTR with and without NERs = total toxic residues = spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy

with and without NERs . One day pre

- flood was assumed in all instances.



### The aerobic aquatic metabolism half

- life value for the TTR excluding the NERs was assumed to be the same than for spirotetramat

- ketohydroxy since it is the most persistent of the degradates and the last one in the degradation sequence. Furthermore, it is the rate determining step.

For watercress, since the time pre

- flood is 1 day (considered fixed), the peak EECs were not considered to vary substantially for the TTR; however, since the parent compound is very labile, the peak EECs were around one order of magnitude smaller. For cranberry, there was substantial variability between the TTR which included the NERs vs. the TTR which excluded the NERs. The discussion of the EECs is relatively limited because there was concern of exceedances of the LOCs only for the peak EECs.

9 All values are rounded to three significant figures.

### 29

Table B II

- 2b. Estimated exposure concentrations of spirotetramat (ppb) in the water column. Cranberry use (a member of the bushberry and low growing berries group),

calculated with the modified Tier 1 Rice model v.1.0. 10


### Crop Scenario/App. rate/No. Apps/Int. Between Apps. Peak/ppb 21

- day/ppb 60

- day/ppb Spirotetramat only

0.16/ 3/ 7

– 1 d pre

- flood 5.50 0.283 0.0991

TTR + NERs

0.16/ 3/ 7

– 1 d pre

- flood 162 157 148

TTR + NERs

0.16/ 3/ 7

– 30 d pre

- flood 141 137 129

TTR (excluding the NERs)

0.16/ 3/ 7

– 1 d pre

- flood 114 110 103

TTR (excluding the NERs)

0.16/ 3/ 7

– 30 d pre

- flood 22.4 21.6 20.3

TTR with and without NERs = total toxic residues = spirotetramat + spirotetramat

- enol + spirotetramat

- ketohydroxy

with and without NERs

.



## Provisional Tier I Rice Model Equations Used for Watercress and Cranberry

Provisional Modified Rice Model (Jones, 2006) 11 

### Equation B 2 incorporates the aerobic aquatic

metabolism.

Equation B 2

where,

C

w 

### = water concentration [μg/L] t = interval since last application [d] k = upper 90 th 

### percentile of aerobic aquatic metabolism study rate constants [1/d]

For cranberry use, the provisional Modified Rice Model water column depth was lengthened to a dept h that is used to flood cranberry bogs ( i.e. , 12 inches; Cape Cod Cranberry Growers Association, 2001 ) 12



### .

i.e.

, d

w 

### = water column depth = 0.305 m (for cranberry bogs)

10 All values are rounded to three significant figures.

11 Jones, R. 2006. Rice Screen Documentation. U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC. Feb. 21, 2006

12 A vailable a t http://www.cranberries.org/

.

### 30

In order to model degradation prior to the flood at harvest, the application rates for n number of pre

- harvest applications were independently degraded over the interim until flooding and then summed (Equation B 3).

Degradation in a Dry Bog , incorporating aerobic soil metabolism is presented in Equation B 3 :

Equation B 3

where,

m ai 

### ' = mass per unit area at flood [kg/ha]

m ai 

### '

n 

### = mass applied per unit area on the n th 

### application [kg/ha]

k 2 

### = upper 90 th 

### percentile of aerobic soil metabolism study rate constants [1/d]

t n 

### = interval from the n th 

### application to harvest [d] n = number of pre

- harvest applications

These equations and parameter sets constitute the provisional Tier I Cranberry Model,

which was similarly used to refine the use on watercress.

Provisional Tier I Cranberry and Watercress Model.

Equation B 4

where,

m ai 

### ' = mass per unit area at flood [kg/ha]

m ai 

### '

n 

### = mass applied per unit area on the n th 

### application [kg/ha]

k 2 

### = upper 90 th 

### percentile of aerobic soil metabolism study rate constants [1/d]

t n 

### = interval from the n th 

### application to harvest [d] n = number of pre

- harvest applications

This is followed by (note that this is an expanded version of Equation B 2 ) :

Equation B 5

Also , if appropriate , like in this instance :

Equation B 6

where,

C

w 

### = water concentration [μg/L]

### 31 t = interval since flood [d]

k = upper 90 th 

### percentile of aerobic aquatic metabolism study rate constants [1/d]

K d 

### = water

- sediment partitioning coefficient [L/kg]

K OC 

### = organic carbon partitioning coefficient [L/kg]

d

w 

### = water column depth = 0.305 m

d sed 

### = sediment depth = 0.01 m θ sed 

### = porosity of sediment = 0.509

ρ b 

### = bulk density of sediment = 1300 kg/m 3



## Sample PRZM/EXAMS Output File

stored as SPIROTET.out
Chemical: Spirotetramat PRZM environment: CARowCropRLF_V2.txt modified Wedday, 26 March 2008 at 10:38:52

EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:07

Metfile: w23234.dvf modified Tueday, 26 August 2008 at 06:15:38
Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 0.2804 0.07003 0.04167 0.02396 0.01597 0.003939

1962 0.281 0.0803 0.04624 0.02674 0.01783 0.004396

1963 0.2807 0.07324 0.04162 0.02384 0.0159 0.003919

1964 0.2805 0.07327 0.04249 0.02486 0.01657 0.004075

1965 0.2806 0.07672 0.04468 0.02554 0.01702 0.004198

1966 0.2806 0.07871 0.04599 0.02632 0 .01755 0.004327

1967 0.2809 0.0737 0.04281 0.0249 0.0166 0.004094

1968 0.2805 0.07634 0.04132 0.02377 0.01585 0.003896

1969 0.2841 0.08409 0.04756 0.02659 0.01773 0.004372

1970 0.2803 0.06884 0.0392 0.02267 0.01511 0.003727

1971 0.2843 0.08275 0.04559 0.02 655 0.0177 0.004364

1972 0.2804 0.0736 0.04261 0.02417 0.01612 0.003963

1973 0.2806 0.07434 0.04313 0.0248 0.01653 0.004077

1974 0.282 0.07705 0.04545 0.0256 0.01707 0.004208

1975 0.2805 0.07549 0.04387 0.02567 0.01711 0.00422

1976 0.282 0.07702 0.04571 0.02641 0.01761 0.00433

1977 0.2805 0.07622 0.04404 0.02514 0.01676 0.004132

1978 0.2833 0.07139 0.04122 0.02355 0.0157 0.003871

1979 0.2812 0.08124 0.04613 0.02559 0.01706 0.004207

1980 0.2823 0.0739 0.04153 0.02397 0.01598 0.003929

1981 0.2805 0.07021 0. 0408 0.02366 0.01578 0.00389

1982 0.2837 0.07462 0.04433 0.02558 0.01705 0.004205

1983 0.2805 0.0732 0.04104 0.02378 0.01585 0.003909

1984 0.2804 0.07044 0.04088 0.02293 0.01529 0.003759

1985 0.2808 0.07591 0.04396 0.0255 0.017 0.004192

1986 0.4 0.09431 0. 04369 0.02578 0.01719 0.004238

1987 0.2832 0.07683 0.04226 0.02387 0.01591 0.003924

1988 0.2804 0.06877 0.03977 0.02287 0.01525 0.003749

1989 0.2893 0.08128 0.04762 0.0259 0.01727 0.004258

1990 0.2836 0.07953 0.0464 0.02607 0.01738 0.004285

Sorted results

Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly

0.032258064516129 0.4 0.09431 0.04762 0.02674 0.01783 0.004396

0.0645161290322581 0.2893 0.08409 0.04756 0.02659 0.01773 0.004372

0.0967741935483871 0.2843 0.08275 0.0464 0.02655 0.0177 0.004364

0.1290322580645 16 0.2841 0.08128 0.04624 0.02641 0.01761 0.00433

0.161290322580645 0.2837 0.08124 0.04613 0.02632 0.01755 0.004327

0.193548387096774 0.2836 0.0803 0.04599 0.02607 0.01738 0.004285

0.225806451612903 0.2833 0.07953 0.04571 0.0259 0.01727 0.004258

0.25806451 6129032 0.2832 0.07871 0.04559 0.02578 0.01719 0.004238

0.290322580645161 0.2823 0.07705 0.04545 0.02567 0.01711 0.00422

### 32

0.32258064516129 0.282 0.07702 0.04468 0.0256 0.01707 0.004208

0.354838709677419 0.282 0.07683 0.04433 0.02559 0.01706 0.004207

0.387096774193548 0.2812 0.07672 0.04404 0.02558 0.01705 0.004205

0.419354838709677 0.281 0.07634 0.04396 0.02554 0.01702 0.004198

0.451612903225806 0.2809 0.07622 0.04387 0.0255 0.017 0.004192

0.483870967741936 0.2808 0.07591 0.04369 0.02514 0.01676 0.004 132

0.516129032258065 0.2807 0.07549 0.04313 0.0249 0.0166 0.004094

0.548387096774194 0.2806 0.07462 0.04281 0.02486 0.01657 0.004077

0.580645161290323 0.2806 0.07434 0.04261 0.0248 0.01653 0.004075

0.612903225806452 0.2806 0.0739 0.04249 0.02417 0.01612 0 .003963

0.645161290322581 0.2805 0.0737 0.04226 0.02397 0.01598 0.003939

0.67741935483871 0.2805 0.0736 0.04167 0.02396 0.01597 0.003929

0.709677419354839 0.2805 0.07327 0.04162 0.02387 0.01591 0.003924

0.741935483870968 0.2805 0.07324 0.04153 0.02384 0.01 59 0.003919

0.774193548387097 0.2805 0.0732 0.04132 0.02378 0.01585 0.003909

0.806451612903226 0.2805 0.07139 0.04122 0.02377 0.01585 0.003896

0.838709677419355 0.2804 0.07044 0.04104 0.02366 0.01578 0.00389

0.870967741935484 0.2804 0.07021 0.04088 0.02355 0.0157 0.003871

0.903225806451613 0.2804 0.07003 0.0408 0.02293 0.01529 0.003759

0.935483870967742 0.2804 0.06884 0.03977 0.02287 0.01525 0.003749

0.967741935483871 0.2803 0.06877 0.0392 0.02267 0.01511 0.003727

0.1 0.28428 0.082603 0.046384 0.026536 0.0 17691 0.0043606
Average of yearly averages: 0.00408843333333333

Inputs generated by pe5.pl

- Novemeber 2006

Data used for this run:
Output File: SPIROTET

Metfile: w23234.dvf

PRZM scenario: CARowCropRLF_V2.txt

EXAMS environment file: pond298.exv

Chemical Name: Spirotetramat
Description Variable Name Value Units Comments Molecular weight mwt 373.45 g/mol

Henry's Law Const. henry 6.90e

- 13 atm

- m^3/mol

Vapor Pressure vapr 4.2e

- 11 torr Solubility sol 33.5 mg/L

Kd Kd 4.39 mg/L

Koc Koc mg/L
Photolysis h alf

- life kdp 14.4 days Half

- life
Aerobic Aquatic Metabolism kbacw 0.2676 days Halfife
Anaerobic Aquatic Metabolism kbacs 2.1 days Halfife

Aerobic Soil Metabolism asm 0.298 days Halfife
Hydrolysis: pH 7 13.1 days Half

- life

Method: CAM 2 integer See PRZM man ual
Incorporation Depth: DEPI 0.0 cm Application Rate: TAPP 0.1121 kg/ha
Application Efficiency: APPEFF 0.95 fraction
Spray Drift DRFT 0.05 fraction of application rate applied to pond
Application Date Date 10

- 02 dd/mm or dd/mmm or dd

- mm or dd

- mmm

Interval 1 interval 7 days Set to 0 or delete line for single app.
app. rate 1 apprate 0.1121 kg/ha

Interval 2 interval 7 days Set to 0 or delete line for single app.
app. rate 2 apprate 0.1121 kg/ha

Interval 3 interval 7 days Set to 0 or delete line for single ap p. app. rate 3 apprate 0.1121 kg/ha

Interval 4 interval 7 days Set to 0 or delete line for single app.
app. rate 4 apprate 0.1121 kg/ha

Record 17: FILTRA

IPSCND 1

UPTKF 0

Record 18: PLVKRT 0

PLDKRT 0

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)

### 33



## Appendix C

. Agency risk quotient (RQ) metrics and levels of concern (LOC) per risk class

Risk Class Risk Description RQ LOC

Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non

- listed animals from acute

exposures Peak EEC/LC 50 1 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use

classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non

- listed and listed animals

from chronic exposures 60

- day EEC/NOEC (fish) 1

21

- day EEC/NOEC (invertebrates)

Terrestrial Animals (mammals and birds)

Acute Potential for effects to non

- listed animals from acute

exposures EEC 2 /LC 50 (Dietary) 0.5

EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use

classification EEC 2 /LC 50 (Dietary) 0.2

EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC 2 /LC 50 (Dietary) 0.1

EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals

from chronic exposures EEC 2 /NOAEC 1

Plants

Non

- Listed Potential for effects to non

- target, non

- listed plants

from exposures EEC/ EC 25 1

Listed Plant Potential for effects to non

- target, listed plants from

exposures EEC/ NOEC 1

EEC/ EC 05

1 LC 50 or EC 50

. 2 Based on upper bound Kenaga values.

### 34



## Appendix D . Evaluation of the Nature of Non

- Extracted Residues (NERs) in Spirotetramat Metabolism Studies (MRID 47576501)

Ramanarayanan, T. 2008. Nature and Fate of Non

- Extractable Residues in Spirotetramat Soil Metabolism Studies. Unpublished study performed by Bayer CropScience Environmental Research, Stilwell, KS, and submitted by Bayer CropScience, RTP, NC. Report No. G201953.

Table 1. Environmental Fate Data Requirements for Spirotetr amat

Guideline

Number Data Requirement MRID# Study

Classification Are Additional

Data Needed

for Risk

Assessment ?

Non

- guideline Nature of NERs of Spirotetramat 47576501 Supplemental Yes 1

1 The registrant should provide additional information characterizing the NERs. Unless proven otherwise, EFED will consider the NERs as repositories of toxic material.



### Summary : Based upon the available data, the Environmental Fate and Effects Division ( EFED )

believes that the un

- extracted or non

- extracted residues (NERs) do not contain parent, or the degradates of concern spirotetramat

- enol or spirotetramat

- ketohydroxy. However, the presence of other toxic chemicals cannot be precluded. 13 

### Unless data are provided that pro ves otherwise, the NERs will continue to be considered repositories of possible toxic material.

Background : Various aerobic and anaerobic soil and aquatic m etabolism studies are available for spirotetramat

, and for its major transformation product, spi rotetramat

- enol. These studies

revealed moderate to rapid degradation of the test subs tances spirotetramat, spirotetramat

- enol and spirotetramat

- ketohydroxy, with formation of very high levels of NERs . In past assessments EFED regarded the formation of high levels of NERs in soils and sediments as a n issue of concern, and the NERs were considered repositories of potentially toxic material. Thus, in its aquatic exposure assessments, the EFED used the rates of degradation of the parent material and

additi onally , calculated half

- lives for the total toxic residues (TTRs)

, which included parent compound, degradates of concern (spirotetramat

- enol and spirotetramat

- ketohydroxy), plus the

NERs. This report submitted by the registrant (MRID 47576501) , is a posit ion paper intended to

address the issue of the NERs.

In a past review ( DP Barcodes D 358765, D362966 , dated 11/08/ 2010 ) , it was stated that since at
the time there were no exceedances of the aquatic levels of concern (LOCs), the issue of the

NERs would be postponed and revisited in case there would be an exceedance of an LOC in a

future assessment

. Since in preliminary calculations there are exceedances of the aquatic LOCs for uses of spirotetramat, at this time EFED is re

- evaluating the NER topic in this review

.

Registrant’s Comments and Its Position on the Issue (MRID 47576501) : According to the registrant, i n aerobic soil metabolism studies, b oth spirotetramat and spirotetramat

- enol degraded rapidly and formed very high levels of NERs (up to 58% AR). The extractions included

13 A sediment toxicit y study (Dorgerloh, 2005 ) that was conducted for a period of 28 days in a spiked water system shows high toxicity towards Chironomus riparius , and likely the sediments contained very high levels of NERs.

### 35

aqueous/organic solvents and more aggressive extractions using strong acidic organic/aqueous

solvents and/or heat (see EFED’s response on the use of high temperature)

. They argue that in

the en vironment, water is the only solvent, and the NERs cannot be expected to be released under these conditions. The NERs should not be considered as a relevant residue in aquatic

exposure assessments.

It was also noted that i n the soil photolysis study that used sterile soil, spirotetramat degraded to spirotetramat

- enol (and spirotetramat

- ketohydroxy in the irradiated samples), with very low

formation of NERs (≤2.1% AR) . In contrast, in the viable sample s of a similar soil photolysis study, and the aerobic soil metabolism studies, spirotetramat degrade d with rapid formation of high levels of NERs. The registrant believes that these results show that spirotetramat degrades to spirotetramat

- enol via hydrolysis and biolysis, but that further degradation of spi rotetramat

enol is only biologically mediated and that formation of NERs in soil is due to the biological degradation of spirotetramat

- enol. “[I]t can be concluded that NER from spirotetramat degradation would be a part of the soil organic matter and not be a relevant residue...”

EFED’s Response: The reason why the NERs are considered to be of concern in certain

assessments is that in the environment, natural solvents, compounds in product formulations, and compounds from tank mixtures may keep pesticides, their transformation products, or both from binding to soil. In the laboratory, pesticide residues may not be studied in the presence of these solvents and may be kinetically inhibited from extraction by soil colloids that are not well disturbed by water , single organic solvents, or extraction conditions such as vigorous shaking, elevated temperatures, and sonication. Also, pesticide residues in the environment may undergo repeated extractions with water over longer time periods than are replicable in th e laboratory.

C onditions in laboratory tests do not reflect the changes in temperature and humidity that soils in the environment undergo. Also , plant roots actively modify soils and s ediments, which can

result in de creased compound binding to soil in th e environment that is not replicated in the laboratory.

EFED note d that only in the aerobic soil metabolism study conducted for spirotetramat

- enol,

microwave extraction was conducted for 10 minutes at 70oC. In all other laboratory studies,

o ther extracti ons were conducted mainly with acetonitrile/water solutions ( at various ratios ) and

at RT . Exhaustive extractions of polar compounds should also involve use of multiple mild solvents with different chemical properties

, since the transformation products ma y be less or

more polar than the parent compound

. A sterile treated system (sterilized using a method that does not alter the soil structure) with low NERs, may be evidence that the NERs at higher levels

in a non

- sterile treated system are not the test co mpound or its transformation products of

concern. It appears from the studies performed with sterile soils that the extraction methods used were efficient in removing the available spirotetramat

, spirotetramat

- enol and spirotetramat

ketohydroxy from the sterile soils since low levels of NERs were observed in such studies

. S pirotetramat

- ketohydroxy was a minor component in the dark control samples, but it reached high levels in the irradiated samples; since the NERs were also low in the irradiated samples

, extraction methods used also appear to be efficient in removing the available spirotetramat

ketohydroxy overall . Since similar extraction methods were used in the aerobic and anaerobic soil metabolism studies for spirotetramat ( i.e. , acetonitrile/water solutions) , compared to the soil photolysis study, the methods were also likely efficient in removing the available spirotetramat

,

### 36

spirotetramat

- enol and spirotetramat

- ketohydroxy from the viable soils; however, what was not extracted may be of concern. I t is further noted that a closer inspection of the study shows that the sterilization method was autoclaving , a method of sterilization with a potential to change the properties and structure of the soil.

In order to evaluate the formation of NERs, severa l of the environmental fate study extraction methods were further inspected. In an aerobic soil metabolism study conducted with the parent compound, intended to follow only the decay of spirotetramat, since the chemical hydrolyzes rapidly in alkaline solu tions, three extractions with acetonitrile/water (1:1, v/v, containing 0.5 % formic acid) , followed by two extract ions with acetonitrile/1N HCl (1:1, v/v, pH ca. 1) , and with acetonitrile (1 x 50 mL) were performed . Very high levels of NERs were observed.

In an another study, conducted with spirotetramat

- enol, to follow only the degradates of spirotetramat, s oil samples were extracted once with water containing 0.025 % NH 3 

### at RT ( pH ~ 7.0 to 8.5) , followed by extract ion three times with acetonitrile/water (1:1, containing 0.1 % ammonium chloride [w/v] and 0.06 % NH 3 

### [v/v]; pH

~ 8.5) by shaking at RT, and finally an “aggressive” microwave extraction was performed at 70 °C ( only 10 min) using the same medium as above. Similarly, very high levels of NERs were observed in this study

.

In the soil photolysis study that used sterile soils, the extractions occurred three times with

acetonitrile / water with 0.5% formic acid (1:1, v:v), shaken at RT for 30 minutes, then two times

with acetonitrile /aqueous 1 N HCl (1:1 , v:v ) and once with acetonitrile. The acetonitrile extract contained <3% AR and was not processed further. The levels of NERs were high only in the

viable soil study conducted separately (and prior to this study). This could indicate that the

extractio n were acceptable for the chemicals spirotetramat, spirotetramat

- enol and spirotetramat

ketohydroxy, which are of concern. Both, the study conducted with the viable and sterile soils have been regarded as supplemental.

Finally, by comparison, in the meth od validation soils were mixed with [25 mL of a solution of ethyl acetate (5 %, v/v) and cysteine hydrochloride (8 g L - 1 

### ) in water, 0.5 mL formic acid, 25 mL acetonitrile], fortified with 1 ml of 13 

### C internal standard solution and extracted by microwave

ex traction (70 °C, 30 min). Extraction (without addition of internal standard) was repeated once. In the method validation, the recoveries of all the test compounds were appropriate ; similar

methods were used in the terrestrial field dissipation studie s.

The parent spirotetramat shows very high solubilities in common solvents such as acetone, dichloromethane and ethyl acetate . None of these solvents were used in the soil metabolism

studies . The degradates spirotetramat

- enol and spirotetramat

- ketohydroxy are likely more polar than the parent compound. In the environmental fate studies the extractions were performed mainly or solely in acetonitrile solutions and with one exception, at RT . It was noted that in the method validation, a solution containing ethyl acetate/cysteine hydrochloride/formic acid/

acetonitrile/water

, was used in combination with high temperatures and a long extraction period (30 minutes)

. The nature of the non

- extracted residues (NERs) has not been clearly elucidated in any of the metabolism studies. Instead, the remaining soils were fractionated to determine fulvic acid, humic acid and humin fractions. This methodology could be misleading and extractable

### 37

residues may have been omitted and not measured. In short, the NERs were no t elucidated in any of the studies and should be regarded as a source of toxic material.

### 38



## Appendix E . Terrestrial Exposure Assessment for the New Uses of Spirotetramat 2012

Table D

- 1

. Input parameters and upper

- bound dose

- based estimated environmental concentrations (EECs) generated u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds

.

Use Max.

Single App.

Rate

(lbs a.i./A) Min.

Interval (Days) Max. No.

Apps. Per

Year EECs in ppm

Size

class 1 Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods Seeds

Parent only 2

Watercress 0.2 7 2 Small 67.23 30.81 37.82 26.33 4.2 0.93

Mid 38.34 17.57 21.57 15.02 2.40 0.53 Large 17.16 7.87 9.66 6.72 1.07 0.24

Banana/

Plantain 0.25 14 5 Small 72.15 33.07 40.58 28.26 4.51 1.00

Mid 41.14 18.86 23.14 16.11 2.57 0.57 Large 18.42 8.44 10.36 7.21 1.15 0.26

Total Residues 2

Watercress 0.2 7 3 Small 76.55 35.09 43.06 29.98 4.78 1.06

Mid 43.65 20.01 24.55 17.10 2.73 0.61 Large 19.54 8.96 10.99 7.65 1.22 0.27

Banana/

Plantain 0.25 14 2 Small 81.37 37.29 45.77 31.87 5.09 1.13

Mid 46.40 21.27 26.10 18.17 2.90 0.64 Large 20.77 9.52 11.68 8.14 1.30 0.29

a There are three size classes of birds including small (20g), medium (100g), and large (1000g). Small birds represent the mos t sensitive size class and therefore the lack of risk concern to small birds from upper

- bound exposure concentrations implies that there will also not be risk to other sizes of birds.

b For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and one non

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

- enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90% confidence limit of the mean half

- lives for the parent and total residue approaches are 3.3 and 5.3 days, respectively.

### 39

Table D

- 2

. Input parameters and upper

- bound dose

- based estimated environmental concentrations (EECs) generated u sing T

- REX v1.5 for the maximum spirotetrama t spray application scenarios of various crops for mammals

.

Use Max.

Single App.

Rate

(lbs a.i./A) Min.

Interval (Days) Max. No.

Apps. Per

Year EECs in ppm

Size

class a Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods Seeds

Parent only b

Watercress 0.2 7 2 Small 56.28 25.80 31.66 22.04 3.52 0.78

Mid 38.90 17.83 21.88 15.24 2.43 0.54 Large 9.02 4.13 5.07 3.53 0.56 0.13

Banana/

Plantains 0.25 14 5 Small 60.40 27.68 33.97 23.66 3.77 0.84

Mid 41.74 19.13 23.48 16.35 2.61 0.58 Large 9.68 4.44 5.44 3.79 0.60 0.13

Total Residues b

Watercress 0.2 7 3 Small 64.08 29.37 36.05 25.10 4.01 0.89

Mid 44.29 20.30 24.91 17.35 2.77 0.62 Large 10.27 4.71 5.78 4.02 0.64 0.14

Banana/

Plantains 0.25 14 2 Small 68.12 31.22 38.32 26.68 4.26 0.95

Mid 47.08 21.58 26.48 18.44 2.94 0.65 Large 10.91 5.00 6.14 4.28 0.68 0.15

a There are three size classes of mammals including small (15g), medium (35g), and large (1000g). Small mammals represent the most sensitive size class and therefore the lack of risk concern to small mammals from upper

- bound exposure concentrations implies that there will also not be risk to other sizes of birds.

b For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and one non

- guideline study (MRID 46904507) for both the paren t spirotetramat as well as for the total residues ( parent spirotetramat, spirotetramat

- enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90% confidence limit of the mean ha lf

- lives for the parent and total residue approaches are 3.3 and 5.3 days, respectively.

### 40

Table D

- 3

. Input parameters and upper

- bound dietary

- based estimated environmental concentrations (EECs) generated u sing T

- REX v1.5 for the maximum spirotetramat spray application scenarios of various crops for birds and mammals

.

Use Max. Single App.

Rate

(lbs a.i./A) Min. Interval

(Days) Max. No. Apps. Per

Year EECs in ppm

Short

Grass Long

Grass Broadleaf

Plants Arthropods Fruits,

Pods
, Seeds Parent only a

Watercress 0.2 7 2 59.03 27.06 33.21 23.12 3.69

Banana/

Plantains 0.25 14 5 63.35 29.03 35.63 24.81 3.96

Total Residues a

Watercress 0.2 7 3 67.22 30.81 37.81 26.33 4.20

Banana/

Plantains 0.25 14 2 71.44 32.74 40.19 27.98 4.47

a For foliar dissipation, 16 foliar half

- life measurements are available from two guideline studies (MRID 46904508 and MRID 46904509) and one non

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

- enol, and spirotetramat

- ketohydroxy) . Assuming these values are distributed normally, the values which represent the one tail upper 90% confidence limit of the mean half

- lives for the parent and total r esidue approaches are 3.3 and 5.3 days, respectively.

### 41

Figure E

- 1. Parent only e xposure l evels from an application of spirotetramat to watercress.

### 42

Figure E

- 2

. Total residue e xposure l evels from an application of spirotetramat to

watercress.

### 43

Figure E

- 3

. Parent only e xposure l evels from an application of spirotetramat to bananas/plantains.

### 44

Figure E

- 4

. Total residue e xposure l evels from an application of spirotetramat to bananas/plantains.