OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION



# Problem Formulation for the
Environmental Fate
, Ecological Risk , and Endangered Species in Support of the Registration Review of

Buprofezin

PC Code 275100
CAS Number 69327

- 76

- 0

C1=CC=CC(=C1)N2C(N(C(SC2)=NC(C)(C)C)C(C)C)=O



### Prepared by: Ronald Parker, Ph.D., Senior Environmental

Engineer Nicholas Mastrota, Wildlife Biologist

Reviewed by : 

### Melissa Panger, Ph.D. Senior Biologist
Rosanna Louie

- Juzwiak, RAPL

A pproved by: Dana Spatz, Branch Chief

May 21, 2012

### 2 TABLE OF CONTENTS

1.0 Description of Regulatory Action

................................ ................................ ...................... 3
2.0 Stressor Source and Distribution

................................ ................................ ....................... 3

2.1 Nature of Stressor

................................ ................................ ................................ ............... 3

2.2 Mode of Action

................................ ................................ ................................ .................. 3

2.3 Conclusion s from Previous Risk Assessments

................................ ................................ .. 3

2.4 Use Characterization

................................ ................................ ................................ .......... 5
3.0 Environmental Fate Summary

................................ ................................ .......................... 8
4.0 Ecological Effects Summary

................................ ................................ ............................ 12

4. 1 Aquatic Effects

................................ ................................ ................................ ................. 12

4.2 Terrestrial Effects

................................ ................................ ................................ ............. 16

4.3 Ecol ogical Incidents

................................ ................................ ................................ ......... 18
5.0 Ecosystems Potentially at Risk

................................ ................................ ......................... 18
6.0 Assessment Endpoints

................................ ................................ ................................ ....... 19
7.0 Conceptual Model

................................ ................................ ................................ ............. 20

7.1 Risk Hypothesis

................................ ................................ ................................ ................ 20

7.2 Conceptual Diagram

................................ ................................ ................................ ......... 21
8.0 Analys is Plan

................................ ................................ ................................ ..................... 22
8.1 Stressors of Concern

................................ ................................ ................................ ......... 22

8.2 Measures of Exposure

................................ ................................ ................................ ...... 23

8.3 Meas ures of Effect

................................ ................................ ................................ ........... 26

8.4 Integration of Exposure and Effects

................................ ................................ ................. 27

8.5 Endangered Species Assessment

................................ ................................ ...................... 27

8.6 Drinking Water Assessment

................................ ................................ ............................. 28
9.0 Clean Water Act

................................ ................................ ................................ ................ 29
10.0 Anticipated Data Needs

................................ ................................ ................................ .... 30

10.1 Environmental Fate

................................ ................................ ................................ ....... 30

10.2 Ecological Effects

................................ ................................ ................................ ......... 30
11.0 Ref erences

................................ ................................ ................................ .......................... 40

### 3



## 1.0 Description of Regulatory Action

This document serves as a problem formulation for the upcoming ecological risk and drinking
water exposure assessment s that the EPA will conduct for buprofezin during the Registration Review process. The problem formulation provides a framework on the purpose and objectives of the risk assessment, evaluates the nature of the problem, and provides a plan for an alyzing the data and characterizing the risk (USEPA, 1998).



## 2.0 Stressor Source and Distribution

2.1 Nature of Stressor

Buprofezin ( CAS Number 69327

- 76

- 0 ) is an insect growth regulator that is used as an active ingredient in insecticidal products. It is cla ssified as a chitin biosynthesis inhibitor (Group 16) by the Insecticide Resistance Action Committee (IRAC). It is available in multiple products that are used to control insects on the stems and foliage of agricultural crops and ornamental plants

. Insect pests that are controlled by buprofezin include whiteflies, mealybugs, scale, leafhoppers, and planthoppers. Products containing buprofezin are formulated either with buprofezin as the sole active ingredient or in combination with flubendiamide. ( BEAD Ch emical Profile for Registration Review: Buprofezin, 15 December 2011 ).

2.2 Mode of Action

Buprofezin controls insects by interrupting the growth and development of the larval stages by inhibiting chitin biosynthesis. It also suppresses oviposition of adult insects and reduces the viability of insect eggs.

2.3 Conclusions from Previous Risk Assessments

Previous risk assessments include an ecological assessment in support of the 2001 Reregistration Eligibility Decision (RED, D271561) and numerous new use assessments, which are summarized

in Table 1

. All recent assessments have identified a risk of chronic effects to mammals above EPA’s level of concern (LOC). Chronic risk was also concluded for birds for uses with higher application r ates, including on most fruit trees (except apple), almonds, and coffee. Acute risk to small mammals exceeded the LOC for endangered species for most uses, and the LOC for non

endangered species for some uses with high use rates (some fruit trees and coff ee). Risk to birds exceeded the acute endangered species LOC for the use on stone fruit and tropical fruit. For terrestrial insects, while an acute contact toxicity test with adult honey bees showed low toxicity, because buprofezin is an insecticide, som e risk to terrestrial insects has been presumed.

Previous assessments generally concluded low acute and chronic risk to fish and aquatic invertebrates, except for endangered aquatic invertebrates from use on coffee. Also, recent

assessments from 2008 con cluded that adverse effects to endangered aquatic invertebrates were possible, based on sublethal effects observed in an acute toxicity study with the waterflea. Previous assessments did not identify any risk to fish exceeding the LOC. All of the previous assessments concluded low risk to terrestrial and aquatic plants.

### 4

A summary of previous human health drinking water exposure assessments is included in section

8.6 below.

Table 1

. Summary of Previous Ecological Risk Assessments on Buprofezin

Assessment ID (Year) Use Max. Application Rate (lbs ai/A) Max.

Seasonal or Yearly Rate (lbs ai/A) R isk I dentified as Exceeding

the EPA Level of C oncern

D271561 (2001) Almonds 2.0 2.0 Chronic risk to birds, acute risk to endangered small mammals

Citrus Fruit 2.0 4.0 Chronic risk to birds, acute risk to endangered small mammals

Grape 0.50 1.0 Acute risk to endangered small

mammals

Cotton 0.35 0.70 None

Bananas 0.31 1.24 Acute risk to endangered small

mammals

D293231, D292582,
D292035 (2004) Pear 1.58 3.16 Chronic risk to birds and mammals, acute risk to small

mammals

Tropical Fruit 1.58 3.16 Chronic risk to birds and mammals, acute risk to endangered birds

Apple 1.5 1.5 Chronic risk to mammals, acute

risk to small mammals

D323242, D323244, D323245 (2007) Stone Fruit 1.5 3.0 Chronic risk to birds and mammals, acute risk to small mammals, acute risk to endangered birds

D340340, D340342 (2008) Olive 2.0 4.0 Chronic risk to birds and mammals, acute risk to endangered small mammals, possible risk to nontarget insects, possible acute risk to endangered aquatic invertebrates

Berries 0.38 0.76 Chronic risk to mammals, possible risk to nontarget insects, possible acute risk to endangered aquatic invertebrates

Leafy Vegetable 0.38 0.76 Chronic risk to mammals, possible risk to nontarget insects, possible acute risk to endangered aquatic invertebrates

D343066 (2008) Fruiting Vegetables 0.38 0.76 Chronic risk to mammals, possible risk to nontarget insects, possible acute risk to endangered aquatic invertebrates

D354845, D354848, D354881, D354893 Coffee 2.0 4.0 Chronic risk to birds and mammals, acute risk to

### 5

Assessment ID (Year) Use Max. Application Rate (lbs ai/A) Max.

Seasonal or Yearly Rate (lbs ai/A) R isk I dentified as Exceeding

the EPA Level of C oncern

(2009) endangered mammals, acute risk to endangered aquatic

invertebrates

Pomegran a te 2.0 3.0 Chronic risk to birds and mammals, acute risk to endangered small mammals

Brassica vegetables 0.38 1.5 Chronic risk to mammals



### 2.4 Use Characterization

Buprofezin is formulated as a n emulsifiable concentrate, soluble concentrate, dry flowable, and wettable powder products

. Acting as a contact insecticide, buprofezin products are applied as a spray to the foliage of plants to control insect pests. The products are used on a variety of agricultural food crops, including leafy and stem vegetables, herbs, fruiting vegetables, melons, fruit trees, grapes, berries, tree nuts, and coffee. Of the fruit tree uses, oranges and pears are crops with the largest uses of buprofezin, but it may also be used on various other citrus, stone, pome, and tropical fruit trees. Use on grapes i ncludes table grapes, raisin grapes, and wine grapes. A major non

- food agricultural use of buprofezin is on cotton. Buprofezin is also used on ornamental plants, including herbaceous plants, shrubs, vines, and trees. Ornamental use is limited to agricul tural sites such as nurseries and greenhouses. A nation al map with 200 6

- 2010 usage data for buprofezin is presented in Figure 1

.

### 6

Figure 1

. Buprofezin Usage by Crop Reporting District (2006

- 2010). (US EPA , 20 1 2 ).

For all crops, buprofezin products are registered for foliar application using either ground equipment or aircraft. Buprofezin is registered for ultra low volume (ULV) applicati on on tomato and ornamental plants. Application of buprofezin through irrigation systems (i.e., chemigation) is prohibited. Labels of buprofezin products contain no restrictions that would prevent application to the crops during bloom. The label for NNI

- 0871 SC (Vetica Insecticide, EPA Reg. No. 71711

- 32), which contains flubendiamide as well as buprofezin, requires that a 15

- ft buffer zone be maintained between the treated field and any aquatic habitat. Products containing buprofezin

alone do not hav e buffer zone requirements. Table 2 below, summarizes the currently registered uses of buprofezin and application information for each crop or use site.

Table 2 . Use Site and Application Information for Buprofezin

Site Description Products 1 AI Single
Maximum Applicatio

n Rate (lb/A) AI

Maximum
Seasonal

Rate 2 (lb/A) Max.

Apps/ Crop Cycle 3 MRI 4

(days) Application

Methods Restrictions

Almond and Pistachio Applaud, Buprofezin 2.01 2.01 1 NA Ground, Airblast,

Aircraft

### 7

Bean, Succulent Applaud, Buprofezin 0.38 0.692 NS 14 Ground,

Aircraft

NNI 0.31 0.692 NS 14 Ground,

Aircraft No aerial

application in

NY Berries (blueberries, cranberries, strawberries) Buprofezin,

NNI 0.34 0.674 2 10 Ground,

Aircraft

NNI 0.34 0.674 2 10 Ground,

Aircraft No aerial

application in

NY

Coffee Applaud 1.01 3.98 NS 14 Ground,

Aircraft

Cotton Applaud, Buprofezin 0.35 (0.70) 2 28 Ground,

Aircraft

NNI 0.66 0.66 1 28 Ground,

Aircraft No aerial

application in

NY Chrysanthemum

NNI 0.31 0.69 NS 7 Ground,

Aircraft No aerial

application in

NY Fruit, Citrus Applaud 2.01 4.02 2 60 Ground,

Aircraft Fruit, Pome (except pears) Applaud, Buprofezin 1.15 1.15 1 NA Ground, Airblast,

Aircraft

NNI 0.31 0.84 NS 7 Ground, Airblast,

Aircraft Fruit, Pome, Pears Applaud, Buprofezin 2.01 3.02 NS 7 Ground,

Aircraft

NNI 0.31 0.84 NS 7 Ground,

Airblast

Aircraft Fruit, Stone (peach, plum, nectarine, apricot, cherry) and Pomegranate Applaud, Buprofezin 2.01 3.02 NS 14 Ground,

Aircraft

NNI 0.26 0.67 NS 14 Ground, Airblast,

Aircraft Fruit, Tropical (includes avocado, guava, and minor crops, excludes banana, mango, papaya) Applaud 1.51 3.02 2 14 Ground,

Aircraft FL, HI, and

PR only

Fruit, Tropical, Banana Applaud 0.31 (1.23) 4 14 Ground,

Aircraft Fruit, Tropical, Mango and Papaya Applaud 0.53 1.97 NS 14 Ground,

Aircraft FL, HI, and

PR only Fruit, Minor Crops, Except Mayhaw (cantistel, longan, lychee, pulasan, rambutan, and Spanish lime) Applaud 1.51 3.02 2 14 Ground,

Aircraft

Fruit, Minor Crops, Mayhaw Applaud, Buprofezin 1.51 1.51 1 NA Ground

### 8 NNI 0.31 0.83 NS 7 Ground,

Airblast Grape Applaud 1.05 1.05 NS NA Ground,

Aircraft CA, AZ only

Applaud 0.53 1.05 2 14 Ground,

Aircraft

NNI 0.26 0.68 NS 14 Ground,

Airblast

Ornamental Plants (trees, Christmas trees, nonbearing fruit and nut trees, shrubs, vines, ground cover, and herbaceous plants) Applaud, Buprofezin 0.613 1.23 2 NS Ground, ULV Spray,

Aircraft

Vegetables,

Brassicaceae (broccoli, cabbage, cauliflower, celery, cauliflower, etc) Buprofezin 0.38 0.77 2 7 Ground,

Aircraft

NNI 0.36 0.73 2 7 Ground,

Aircraft No aerial

application in

NY Vegetable,

Cucurbitaceae (cucumbers, gourds, melons, pumpkin) Applaud, Buprofezin 0.38 (0.76) 2 (4/yr) 7 Ground,

Aircraft

Vegetables, Fruiting (tomato, pepper, eggplant, etc) Applaud, Buprofezin 0.38 (0.76) 2 5 (28) Ground,

Aircraft

NNI 0.31 0.69 NS 5 Ground,

Aircraft No aerial

application in

NY

Tallus 0.38 (0.69) 2 28 Greenhouse

sprayers For use in

greenhouses only; CA, CO, PA, and VA only

Courier 0.38 (0.69) 2 28 Ground,

Aircraft CA only

Vegetables, Leafy, Excluding Brassicacea (lettuce, spinach, etc) and Herbs (chervil, fennel, parsley) Buprofezin 0.38 0.77 2 (4/yr) 7 Ground,

Aircraft

NNI 0.31 0.69 NS 7 Ground,

Aircraft No aerial

application in

NY

1 Applaud : Applaud 70DF Insect Growth Regulator (71711

- 21) and Applaud 70WP Insect Growth Regulator (71711

- 15); Buprofezin : Buprofezin 40SC (71711

- 20); NNI : NNI

- 0772 SC (Tourismo Insecticide, 71711

- 33) and

NNI

- 0871 SC (Vetica Insecticide, 71711

- 32); Courier : Courier 40SC Insect Growth Regulator (CA050008 and FL040012); Talus : Talus 40SC Insect Growth Regulator (CA070010, CO070005, PA070004. VA07001) 2 Values in parenthesis are not stated on the label but were assumed to be th e product of the single application rate and the maximum number of applications.
3 NS = Not stated

4 MRI = minimum retreatment interval



## 3.0 Environmental Fate Summary

The environmental fate database for buprofezin is considered essentially complete. A summary of buprofezin’s chemical and physical properties, and environmental fate, including degradation

### 9

half

- li ves and BCF values, is provided below

. The limitations and assumptions presented in previous assessments al so are included in this problem formulation

.

Terrestrial Environments : In terrestrial environments, buprofezin may persist for weeks to months, with biodegradation in soil as the primary route of dissipation. Aerobic soil metabolism

half

- lives were meas ured at 37 and 101 days for a sandy loam and sandy clay loam soil, respectively, and buprofezin was found to be stable to photolysis on soil. Field dissipation studies indicate that buprofezin dissipated at relatively consistent rates, with half

- lives of 3 8 days in a sandy loam (Fresno, CA) and in a loamy sand (Pikeville, NC) when applied four times to bare ground at an application rate of 0.38 lb a.i./A/app. Buprofezin is not expected to volatilize from

soil ( vapor pressure: 6.4 x e - 6 

### mm Hg). No major degr adates other than carbon dioxide were

found in soil metabolism studies.

Laboratory results suggest that buprofezin has moderate to low mobility in soil with measured K d 

### values ranging from 1 1 mL/g to 277 mL/g

. The fraction of organic matter in the soil wa s not found to explain the variability in sorption and so binding to organic matter may not play as large a role as binding to the mineral fraction of soil.

Given its sorption characteristics , buprofezin also has a low potential to leach or move with

sur face water runoff as a dissolved fraction. Consistent with these results, there is no evidence of buprofezin leaching in the terrestrial field dissipation studies; neither buprofezin n or its degradates were detected below 7.5 cm. (See Buprofezin Degradates section below.) Therefore, buprofezin is expected to be persistent in terrestrial soils, with only slow dissipation by transport in surface and ground water.

Aqueous Environments : As described above, buprofezin binds moderately to soil and therefore is expected to reach surface water primarily by way of spray drift or bound soil particles eroded during runoff events

.

Once in an aquatic system, buprofezin is stable to hydrolysis in neutral and alkaline conditions but it does hydrolyze slowly in acidic conditions (half

- life of 58 days). In clear, shallow water bodies, photolysis may contribute to degradation of buprofezin (half

- life = 38 days).

Volatility studies were not submitted, but some volatilization was observed when buprofezin was applied to a thin, moist soil layer, irradiated, and continuously purged with air (soil photolysis study: MRID 44435902). However, under the conditions of the aerobic soil metabolism study,

volatilization was not detected. EFED believes that buprofezin physical properties (molecular weight of 305, melting point of 105 C and Henry’s Law Constant of 6.73 x 10 - 6 

### atm

- m 3 

### /mole) support the aerobic soil metabolism s tudy findings and volatilization from soil is insignificant under field conditions. For volatility in water, based on Henry's Law constant (6.73 x 10 - 6 

### atm

-

m 3 

### /mole), buprofezin is classified as a semi

- volatile compound. Therefore volatilization of buprof ezin may be expected from water bodies. See Table 3, for a summary of buprofezin’s chemical, physical, and environmental fate properties.

### 10

Table 3 . Chemical, Physical and Environmental Fate Properties of Buprofezin

PARAMETER Valu e Study

Summary of Chemical and Physical Properties

Chemical name(s) 2

- tert

- butylimino

- 3

- isopropyl

5phenylperhydro

- 1,3,5

- thiadiazin

- 4

- one

Chemical Abstract Service number 69327

- 76

- 0

PC Code 275100 Empirical Formula C 16 H 23 N 3 OS
Physical State Solid 428738

- 04

Odor Odorless 428738

- 04

Color White 428738

- 04
Melting Point 104.2

- 105.5 C 428738

- 04
Molecular weight (gr/moles) 305.4 Calculated
Aqueous solubility (at 25 C) 0.382 mg/L 428738

- 04 Henry’s Law Constant 6.73 x 10 - 6 atm

- m 3 /mole Calculated
Vapor pressure (at 20 C) 6.4 x e - 6 mm Hg 428738

- 04

Log Kow (at 20 o C) 4.31 428738

- 04

Summary of Environmental Fate Properties MRID

Hydrolysis half life (pH 5) (days) (pH 7) (pH 9) 51 days

stable

stable 44394041

Aqueous photolysis half life (days) 38 days 44463102
Soil photolysis half life (days) 39 days 44453902

Aerobic soil metabolism half

- lives (days)

- Sandy loam soil

- Sandy clay loam soil 36.5 days 101 days 44394042

Anaerobic aquatic metabolism half

- lives stable 44394043

Soil

- water partition coefficient (K d ) K ads values of 11 mL/g in sand soil; 85 in clay loam soil; 69, 87, and 90 in three sandy loam soils; 70 in loamy sand soil; and 277 in silty clay loam soil.

K des values were 7.7 mL/g in sand soil; 173 in clay loam soil; 65, 85, and 118 in sandy loam soils; 71 in loamy sand soil; and 330 in silty clay loam soil. 44990601



### No data are available for biodegradation of buprofezin in aerobic aquatic environments, but in anaerobic aquatic environments, buprofezin was found to be stable to metabolism.

### 11

Given the soil sorption coefficients observed in laboratory studies, buprofezin is likely to partition to sediment or suspended particles. Along with its relative per sistence in aquatic environments, buprofezin can be expected to accumulate in sediments. An aerobic aquatic metabolism study would help to inform this prediction.

Buprofezin Degradates

Three major degradates were observed in the laboratory aqueous studies : BF

- 12 and BF

- 25 1


### ( formed through hydrolysis at pH 5 ) , and BF

- 21 ( formed through aquatic photolysis )

. No major degradate (except for CO 2 

### ) was detected in the laboratory soil studies; however BF

- 12 was seen as a minor degradate under both aerobic an d anaerobic conditions. This suggests that it is unlikely that any buprofezin degradates found in the laboratory studies will form or accumulate in significant quantities in the field. W hen analyzed for in the terrestrial field samples, BF

- 12 was

detected at maximum

, less than 10% of parent and only in the top soil layer (0

- 12 inches). Therefore, as with the parent, buprofezin degradates do not appear to have the potential to leach into ground water. Table 4 lists all degradates/metabolites (minor (x) and major (X)) identified in both laboratory and field studies. Proposed degradation pathways for buprofezin in soil, water, and light are presente d in Appendix B

. N ames , chemical structures of buprofezin

, and major transformation products are presented in Appendix C

, at the end of this report.

Table 4

. Degradates (Minor(x) and Major(X)) Identified in Laboratory and Field St udies

Degradates /
Metabolites Hydrolysis Photolysis (water) Photolysis

(soil) Aerobic Soil Anaerobic

Water Terrestrial

Field

BF

- 2 x

BF

- 9 x x

BF

- 10 x x x

BF

- 11 x (pH 5) x x

BF

- 12 X (pH 5) x x x x (top layer)

BF

- 16 x

BF

- 19 x x

BF

- 21 X

BF

- 22 x

BF

- 25 X (pH 5) x

Unknown C 14 x

CO 2 X x

1 BF

- 12 : N

- (l

- methylethy1)

- N’

- phenylurea

BF

- 25 : N

- [[(1, l

- dimethylethyl)amino]thioxomethyl]

- N

- (1

- methyleyl)

- N’

- phenylea; thiobiuret

BF

- 21: N

- phenylformamide

### 12

BF

- 2 = 2

- [(1,1

- dimethylethyl)imino]tetrahydro

- 5

- (4

- hydroxyphenyl)

- 3

- (1

- methylethyl)

- 4H

- 1,3,5

- thiadiazin

- 4

- one BF

- 9 = dihydro

- 3

- (1

- methylethyl)

- 5

- phenyl

- 2H

- 1,3,5

- thiadiazine

- 2,4(3H)

- dione

BF

- 10 = 2

- [(1,1

- dimethylethyl)imino]tetrahydro

- 3

- (1

- methylethyl)

- 5

- phenyl

- 4H

- 1,3,5

- thiadiazin

- 4

- one 1

- oxide

BF

- 11 = N

- (1,1

- dimethylethyl)

- 2

- (1

- methylethyl)

- N ’

- phenylimidodicarbonic diamide

BF

- 12 = N

- (1

- methylethyl)

- N ’

- phenylurea

BF

- 13 = N

- (4

- hydroxyphenyl)

- N

- isopropylurea

BF

- 16 = phenylurea

BF

- 19 = 6

- [(1,1

- dimethylethyl)amino]

- 2,3

- dihydro

- 3

- phenyl

- 4H

- 1,3,5

- thiadiazin

- 4

- one BF

- 21 = N

- phenylformamide

BF

- 22 = 4

- aminophenol

BF

- 25 = N

- [[(1,1

- dimethylethyl)amino]thioxomethyl]

- N

- (1

- methylethyl)

- N ’

- phenylurea; thiobiuret



### The environmental fate database for buprofezin ’s major degradates (BF

- 12, BF

- 21, and BF

- 25) is incomplete and does not allow a quantitative assessment of their impact on water resources. However, based on the available data, the proposed use rates, and the estimated EECs of buprofezin, it is not expected that these degradates will form or accumulate in significant quantities in the field, or reach ground and surface water at any appreciable concentration. Furthermore, the HED/MARC meeting concluded that buprofezin (parent) was the only res idue of concern in drinking water (D264546, T. Bloem, 20 Apr il 2000). Additional environmental fate data for buprofezin degradates are therefore not needed.

Buprofezin has a low to moderate propensity to bioaccumulate in aquatic organisms. The log of

t he octanol water partitioning coefficient (log Kow) is 4.31, indicating that it may accumulate in fatty tissue. However, a bioaccumulation study with the bluegill sunfish (44394047) found limited bioconcentration, with measured bioconcentration factors of 86 in fillet, 846 in viscera,

and 537 in whole fish. Depuration was rapid, with depuration of 92%, 99% and 98% of the [ 14 

### C] accumulated residues from the edible, non

- edible and whole fish tissue samples, respectively, within 7 days. The rapid depuration appears to limit the bioconcentration of the compound in

fish.



## 4.0 Ecological Effects Summary

4.1 Aquatic Effects

Table 5 presents the data on the acute toxicity of buprofezin to aquatic animals and plants. Freshwater fish also serve as a surrogate to assess risk to aquatic

- phase amphibians. Acute toxicity test ing demonstrates that buprofezin is not acutely toxic to fish and aquatic invertebrates at the solubility limit. This has been shown in both freshwater and saltwater species. Kikuchi et al . (2000), in a test of the acute toxicity of buprofezin with Daphnia magna , found that the acute

48

- hr EC 50 

### was greater than 320 μg/L. Because the limited solubility of buprofezin in water prevented determination of definitive acute endpoints, the acute toxicity cannot be categorized. However, because buprofezin concentra tions in natural waters are not expected to exceed the solubility limit, results of acute toxicity testing are adequate for concluding that exposure to buprofezin will not result in significant acute toxicity to fish and aquatic invertebrates.

Except for the oyster shell deposition study, the study reports for all of the acute aquatic toxicity studies did not give any indication that the test solutions were filtered or centrifuged prior to

### 13

chemical analysis. Because of concern that the measurements of unf iltered samples overestimated concentrations of dissolved buprofezin, the classification of all of the acute toxicity studies, except for the shell deposition study, was downgraded from acceptable to supplemental

in the EFED risk assessment which was condu cted to support new uses on citrus, almonds, grapes, cotton and bananas ( 5/ 2001).

Table 5 . Acute Toxicity of Buprofezin to Aquatic Species

Taxonomic Group, Study Type Surrogate Species Toxicity (Expressed as AI) Citation

MRID Study

Classification

Fish

Freshwater fish,

Acute Bluegill Sunfish

( Lepomis macrochirus ) LC 50 > 330 μg/L (No mortality or adverse effects were observed; highest
test level was close to the solubility limit) 44394015 Supplemental 1

Rainbow Trout ( Oncorhynchus mykiss ) LC 50 > 330 μg/L (No mortality or adverse effects were observed; highest

test level was close to the solubility limit) 44394016 Supplemental 1

Saltwater fish,

Acute Sheepshead minnow

( Cyprinodon variegatus ) LC 50 > 500 μg/L (No mortality or adverse effects were observed; highest

test level was close to the solubility limit) 44394018 Supplemental 1

Aquatic Invertebrates

Freshwater invertebrates,

Acute Water flea

( Daphnia magna ) 48

- hr E C 50 > 420 μg /L 42873833 Supplemental 1

Saltwater mollusc, shell deposition Eastern oyster

( Crassostrea virginica ) 96

- hr IC 50 > 187 μg/L 44394019 Acceptable

Saltwater invertebrate, Acute Grass shrimp

(Palaemonetes pugio) 96

- hr L C 50 > 560 μg/L 44394020 Supplemental 1

Aquatic Plants

Algae Green algae

( Pseudokrichneriella subcapitata ) 72

- hr IC 50 > 382 μg/L

( solubility limit ), 10% growth inhibition at solubility limit. 44394039 Supplemental 1

Vascular Aquatic

Plants Duckweed

( Lemna gibba) 14

- day IC 50 > 400 μg/L,

No inhibition at the solubility

limit. 44394038 Supplemental 1

1 The study was classified as supplemental because the measured test concentration were based on unfiltered samples and thus may have included undi s solved test material. The study nevertheless provides adequate information on acute toxicity for ecological risk assessments.



### Table 6 presents data on the chronic toxicity of buprofezin to fish and aquatic invertebrates. The assessment of chronic effects is uncertain and incomplete because of problems with several of the submitted chronic toxicity studies. For fish, the only acceptable study was a fish early life

- stage study (MRID 44394021), which found that chronic exposure of buprofezin inhibits the growth of

rainbow trout at concentrations as low as 76 μg/L with a NOAEC established at 52 μg/L. A recent supplemental life

- cycle study with the fathead minnow (MRID 48083904) found

### 14

significant decreases in the number of eggs p roduced and percent spawning frequency at all test concentrations, including at the lowest test concentration (8.4 μg ai/L). Because significant effects were observed at all test concentrations, the study failed to establish an NOAEC. These reproductive results are uncertain, because they were confounded by very high variability in reproductive success among replicates, even in the controls. This study also found a significant

reduction of growth at 15 μg ai/L. This result is also uncertain because no s ignificant growth effect was observed at the higher concentration of 28 μg ai/L. The study gave clear evidence that chronic exposure to buprofezin adversely affects growth at concentrations of 55 μg ai/L and above, which is consistent with the results of t he fish early life

- stage study.

Along with the fish life

- cycle study, the registrant provided an additional fecundity study on the adult fathead minnow to better characterize the potential effects of buprofezin on reproduction. This fecundity study yiel ded a NOAEC of 56 μg ai/L, and a LOAEC of 116 μg ai/L, based on significant effects on egg production. It should be noted, however, that the fecundity study was initiated with breeding groups of adult minnow. Thus, the results may not be as sensitive as those obtained during a full life

- cycle toxicity test, which is initiated with embryos. Furthermore, the fecundity study involves only 21 days of exposure, which is a much shorter duration than in the

full life

- cycle study (281 days). Results on reproduc tive endpoints from the original study, while uncertain, indicate that reproduction may be significantly more impaired during the full life

- cycle exposure. Therefore, to address these uncertainties in the chronic toxicity of buprofezin to fish,

the EPA is requesting the registrant to submit a new fish life

- cycle study.

Table 6 . Chronic Toxicity of Buprofezin to Aquatic Species

Taxonomic Group, Study Type Surrogate Species Toxicity (Expressed as AI) Citation

MRID Study

Classification

Fish 1

Freshwater fish, Early Life

- Stage Rainbow Trout

( Oncorhynchus mykiss ) NOAEC = 52 μg/L LOAEC = 76 μg/L (Reduced growth of young) 44394021 Acceptable

Freshwater fish, Life Cycle Fathead Minnow

( Pimephales promelas ) NOAEC = 78 μg/L LOAEC = 170 μg/L (Reduced hatching success and reduced survival of young) 42873834 Supplemental

Freshwater fish, Life Cycle Fathead Minnow

( Pimephales promelas ) Survival: NOAEC = 55 μg/L LOAEC > 55 μg/L
Growth: NOAEC = 8.4 μg/L LOAEC = 15 μg/L Reproduction: NOAEC < 8.4 μg/L LOAEC = 8.4 μg/L 48083904 Supplemental

Aquatic Invertebrates

Freshwater invertebrates,

Chronic Water flea

( Daphnia magna ) Survival: NOAEC = 360 μg/L LOAEC > 360 μg/L Reproduction: NOAEC = 80 μg/L LOAEC = 120 μg/L
Growth: 44435901 Acceptable

### 15

Taxonomic Group, Study Type Surrogate Species Toxicity (Expressed as AI) Citation

MRID Study

Classification

NOAEC = 120 μg/L LOAEC = 200 μg/L

Saltwater
Invertebrate Life

Cycle Mysid

( Americamysis bahia ) Survival: NOAEC = 22.5 μg/L LOAEC = 45.2 μg/L 47676702 Supplemental

Freshwater

Benthic

Invertebrate with Spiked Sediment,

Subchronic (OECD 218) Midge

( Chironomous riparius ) Sediment Concentrations

Survival:

10

- d EC 50 >5.54 mg/kg

10

- d NOAEC: 5.54 mg /kg

10

- d LOAEC: >5.54 mg /kg Emergence : 28

- d EC 50 : >5.54 mg/kg

28

- d NOAEC: 5.54 mg/kg

28

- d LOAEC: >5.54 mg/kg

Dev elopment Rate : 28

- d EC 50 : >5.54 mg/kg

28

- d NOAEC: 2.72 mg/kg

28

- d LOAEC: 5.54 mg/kg

Growth: Not measured 47676703 Supplemental 2

Freshwater

Benthic

Invertebrate with Spiked Water,

subch ronic (OECD 219) Midge

( Chironomous riparius ) Emergence and Development Rate, Pore Water Conc.:

28

- d NOAEC = 15 μ g/L

28

- d LOAEC > 15 μ g/L

28

- d EC 50 > 15 μ g/L Emergence and Development Rate, Overlying Water Conc.:

28

- d NOAEC = 35 μ g/L

28

- d LOAEC > 35 μ g/L

28

- d EC 50 > 35 μ g/L

Growth: Not m easured 46597901 Supplemental

1 F ish serve as surrogate species for aquatic phase amphibians.

2 This study was conducted according to OECD Guideline 218 which measures 28

- day emergence of the midge with spiked sediment exposure. While the test design does not match any OPPTS test guideline, the study does provide information on acute toxicity that is similar to that provided by Guideline 850.1735

.



### The life

- cycle study conducted with Daphnia magna (MRID 44435901) provides acceptable

information on the chronic toxicity of buprofezin to freshwater crustaceans. Based on the observation of significant adverse effects on reproduction at 120 μg ai/L, 

### this study established the chronic NOAEC at 80 μg ai/L. The life

- cycle study conducted with the mysid ( America mysis
bahia ) (MRID 47676702) was classified as supplemental and provides limited information on the chronic toxicity of buprofezin to marine and estuarine crustaceans. Based on the observed reduction of survival at 31 days, this study established the chron ic NOAEC and LOAEC of 22.5 μg ai/L and 45.2 μg ai/L, respectively. These studies indicate that the mysid is more sensitive to chronic exposures of buprofezin than Daphnia magna

.

For chronic effects of buprofezin to sediment

- dwelling invertebrates, current ly, only data from supplemental studies are available. Two studies with Chironomous riparius were submitted and evaluated: one conducted with spiked sediment according to OECD guideline 218 (MRID 47676703) , and a second conducted with spiked water according to OECD guideline 219 (MRID 46597901) . Neither study provides adequate information to fully assess the chronic risk of

### 16

buprofezin to sediment

- dwelling invertebrates. The studies were conducted for a sho rter duration than recommended in the OCSPP test guideline for chronic chironomid testing (850.17 6 0), and also were lacking required measurements on growth (length and dry weight). New acceptable

studies are needed to full y assess risk from buprofezin.

4.2 Terrestrial Effects

Table 7 presents the toxicity data that the EPA plans to use to assess the risk of buprofezin to terrestrial animals and plants. Birds act as surrogates for reptiles and terrestrial

- phase amphibians when data on those species are not available. Overall the toxicity data indicate that buprofezin has low acute toxicity to terrestrial vertebrates. Acute toxicity studies show that buprofezin is practically nontoxic to birds and slightly toxic to mammals . Studies on dermal and inhalation toxicity in mammals found no mortality at the doses tested, indicating low acute toxicity through these exposure routes. These studies categorized the toxicity category for mammalian dermal and inhalation toxicity as IV for the tested formulated product (40% ai), and categories III

- IV for the technical product. Toxicity studies have shown that buprofezin can cause chronic toxic effects to both birds and mammals. An avian reproductive test with the northern bobwhite foun d significant eggshell thinning and reduction of 14

- day

- old chick weights at a dietary exposure of 2000 mg ai/kg diet, establishing an NOAEC at 500 mg ai/kg diet. A 2

- generation reproduction test with mammals found reduced pup weight in rats exposed at 10 00 mg ai/kg diet, and established the chronic NOAEL at 100 mg ai/kg diet.

Table 7 . Acute and Chronic Toxicity of Buprofezin to Terrestrial Species.

Taxonomic Group, Study Type Surrogate Species Toxicity (expressed as AI) Citation

MRID Study

Classification

Birds 1

Birds, Acute
Oral Mallard

( Anas platyrhynchos ) LD 50 > 2000 mg/kg bw 42873827 Acceptable

Northern Bobwhite ( Colinus viginianus ) LD 50 > 2000 mg/kg bw 42873828 Acceptable

Birds, Subacute Dietary Mallard

( Anas platyrhynchos ) LC 50 > 5090 mg/kg diet 42873829 Acceptable

Northern Bobwhite ( Colinus viginianus ) LC 50 > 5243 mg/kg diet 42873830 Acceptable

Birds, Chronic Mallard

( Anas platyrhynchos ) NOAEC= 2000 mg/kg diet LOAEC > 2000 mg/kg diet 44394014 Acceptable

Northern Bobwhite ( Colinus viginianus ) NOAEC= 500 mg/kg diet LOAEC = 2000 mg/kg diet (decreased eggshell thickness, decreased growth of chicks) 44394013 Acceptable

Mammals
Mammals,

Acute Oral Laboratory rat

( Rattus norvegicus ) LD 50 = 1635 mg/kg bw (males) 42873806 Acceptable

Mammals,

Acute Dermal Laboratory rat

( Rattus norvegicus ) LD 50 > 2000 mg/kg bw 2 42873822 Acceptable

Mammals, Laboratory rat LC 50 > 0.832 mg/L 3 45699101 Acceptable

### 17

Taxonomic Group, Study Type Surrogate Species Toxicity (expressed as AI) Citation

MRID Study

Classification

Acute Inhalation ( Rattus norvegicus ) Mammals,

Chronic (2

- generation reproduction) Laboratory rat

( Rattus norvegicus ) NOAEC = 100 mg/kg diet LOAEC = 1000 mg/kg diet (reduced pup weight) 42873814 Acceptable

Terrestrial Insects

Insects Honey bee (adult)

( Apis mellifera L. ) LD 50 (contact) > 200 μg/bee 44394040 Acceptable

Terrestrial Plants

Terrestrial Plants, Seedling Emergence Cabbage, cucumber,

lettuce, radish, soybean, tomato, corn, oat, onion,

wheat Inhibition 0

- 12% at 4.0 lbs

ai/A 44394036 Acceptable

Terrestrial Plants, Vegetative Vigor Cabbage, cucumber,

lettuce, radish, soybean, tomato, corn, oat, onion,

wheat 0

- 16% inhibition

at 4.0 lbs ai/A 44394037 Acceptable

1. Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2. This study was conducted with the formulated product Liquid Applaud 40 SC (40% buprofezin). The toxicity endpoint was converted to represent toxicity of the active ingredient.

3. This study was conducted with the formulated product Buprofezin 40 SC (40% buprofezin). The toxicity endpoint was converted t o represent toxicity of the active ingredient.



### Passerine Toxicity Testing

Toxicity data with the mallard and northern bobwhite has shown that buprofezin is practically nontoxic to birds. No mortality was observed in tests with either species when they were administered a dose of 2000 mg ai/kg bw, or given a dietary concentration of over 5000 mg/kg ( Table 7 ). No frank sublethal effects were observed in these studies. Furthermore, since buprofezin is an insect growth regulator and has a mode of action that is not relevant to terrestrial vertebrates (chitin biosynthesis inhibition), acute toxicity to birds is expected to be minimal. Therefore, an acute oral toxicity test (850.2100) with a passerine bird would not likely show any toxic effects and would not likely change the conclusion of low acute toxicity to birds which have

been made in previous assessment s . Therefore, the EPA does not anticipate needing this study for assessing ecological risk.

Insect Pollinator Testing

An acute contact test with adult honey bees determined the LD 50 

### to be greater than 200 μg/bee, classifying it as practically nontoxic. However, being that buprofezin is an insect growth regulator

that inhibits chitin biosynthesis, toxicity is likely to be much greater to eggs and larval stages of bees and other insect pollinators than to the adult bees. Therefore, a laboratory bee larvae toxicity

stud y would help to better assess the potential effects of buprofezin on insect pollinators.

Toxicity studies b y Mommaerts et al. (2006) with the bumblebee ( Bombus terrestris ) provide some information on the hazard of buprofezin to bees from reproductive and developmental toxicity. While the study found no evidence of acute toxicity of buprofezin to adult bees, adv erse effects on reproduction and survival of larval stages were observed. In one set of tests, worker

### 18

bumblebees were exposed to a concentration of 75 mg ai/L, the maximum field recommended concentration (MFRC) for Applaud® Insecticide. Bees were exposed either dermally through topical application, orally through treated sugar water, or orally through treated pollen. Dermal exposure did not result in any significant adverse effects. Exposure through water caused significant adverse effects to reproduction (decreased number of males produced and decreased egg hatching). Exposure through pollen caused significant adverse effect to reproduction (decreased number of males produced) and larval development (increased number of dead 1 st 

### and

2 nd 

### instar larvae). In a second set of tests using multiple treatment levels at logarithmic serial dilutions, exposure of buprofezin through pollen caused significant adverse effects to reproduction, with NOAEC and LOAEC values established at 1/100 the MFRC (0.75 mg ai/L)

and 1 /10 the MFRC (7.5 mg ai/L) and respectively. Measurements of the number of males produced per nest with five workers yielded EC 50 

### values of 69 mg ai/L with exposure through sugar water and 79 mg ai/L with exposure through pollen. The authors of this paper noted, however, that the adverse effects they observed in tests with buprofezin were relatively weak compared to those they observed in identical tests with two other chitin synthesis inhibiting insecticides, diflubenzuron and teflubenzuron.

Terrestrial P lant Testing

Tier 1 phytotoxicity tests with ten crop species show that buprofezin caused no more than minor inhibition (<25%) of emergence and growth of terrestrial plants when tested at the rate of 4.0 lbs ai/A. Since this application rate equals the hi ghest maximum seasonal application rate (4.0 lbs ai/A for citrus trees and coffee), these data are adequate for demonstrating that buprofezin would pose minimal risk to terrestrial plants.

4.3 Ecological Incidents

A preliminary review of the Ecological Incident Information System (EIIS, version 2.1) in January 2012 did not identify any reported ecological incident of adverse field effects to nontarget plants or animals attributed to the use of buprofezin. Also, rev iew of the Avian Incident Monitoring System (AIMS), which is maintained by the American Bird Conservancy, did not identify any ecological incident associated with the use of buprofezin.

In addition to the incidents recorded in EIIS and AIMS, the EPA mai ntains a database that stores counts of minor incidents that pesticide registrants record in quarterly aggregated incident reports. Ecological incidents recorded in these aggregated reports include those categorized as ‘minor fish and wildlife’ (W

- B), ‘mi nor plant’ (P

- B), and ‘other non

- target’ (ONT) incidents. ‘Other non

target’ incidents include reports of adverse effects to insects and other terrestrial invertebrates. A review of this database in January 2012 did not identify any minor fish, wildlife, plant, or other

non

- target incident associated with use of buprofezin.



## 5.0 Ecosystems Potentially at Risk

Terrestrial habitats near treated agricultural sites may be exposed through spray drift and other

off

- site movement of the applied pesticide. Furthe rmore, terrestrial animals that use treated fields, orchards, and vineyards may be exposed from direct application of spray and from feeding

### 19

on contaminated food items. As the toxicity of buprofezin is specific to early life

- stages of invertebrates, risk to terrestrial habitats is expected to be limited mainly to adverse direct effects on terrestrial arthropods, and indirect effects that may occur to animals that depend on terrestrial arthropods.

Aquatic habitats near and downstream of treated fields and orchards may be at risk. These habitats may be exposed from contaminated runoff from the treated use sites, as well as by spray drift and movement of contaminated soil particles. Because applications of buprofezin can occur in coastal areas, exposure may occur to saltwater as well as freshwater ecosystems. Exposure of aquatic habitats with buprofezin is expected to pose little risk to adult organisms, but toxicity data indicate chronic exposure may pose risk to aquatic animals as the result of adverse ef fects on reproduction and development of early life

- stages. Because buprofezin binds to sediment and is relatively persistent, buprofezin may accumulate in sediment, potentially resulting in risk to ecosystems associated with benthic freshwater and estuar ine habitats.

Use of buprofezin occurs in all regions of the United States, including Hawaii and Puerto Rico. Habitats in regions with high concentrations of fruit, nut, and vegetable production are expected to be at greatest potential risk. Buprofezin is not registered for use on forests, pastures, rangelands, or grain crops. Therefore, ecological risk in regions dominated by these land uses is expected to be minimal. Also, since buprofezin is not registered for residential use, risk to regions domina ted by urban and suburban areas is also expected to be minimal.



## 6.0 Assessment Endpoints

A summary of the assessment and measurement endpoints selected to characterize potential ecological risks associated with exposure to buprofezin are summarized in Table 8 . The ecological relevance of selecting these assessment endpoints is as follows: 1) complete exposure pathways exist for these receptors, 2) the receptors may be potentially sensitive to pesticides in affected media and residues in aquatic organisms, and 3) the receptors could potentially inhabit water bodies receiving pesticides from treated use sites.

The planned risk assessment is not intended to represent a site or time

- specific analysis, but is intended to represent high

- end exposures at a national level. Likewise, the most sensitive toxicity endpoints are used from surrogate test species to estimate treatment

- related direct effects on acute mortality and chronic reproductive, growth and survival assessment endpoints. Toxicity tests are intended to determine effects of pesticide exposure on birds, mammals, fish, terrestrial and aquatic invertebrates, and plants. These tests include short

- term acute, subacute, and reproduction studies and are typically arranged in a hierarchical or tiered system that progresses from basic laboratory tests to applied field studies. The toxicity studies are used to evaluate the potential of a pesticide to cause ad verse effects, to determine whether further testing is required, and to determine the need for precautionary label statements to minimize the potential adverse effects to

non

- target animals and plants (40 CFR §158.202, 2002).

In order to protect threatened and endangered species, all assessment endpoints are measured at the individual level. Measuring endpoints at the individual level also provides insight about risks at higher levels of biological organization (e.g. population and communities). For example,

### 20

pesticide effects on individual survivorship have important implications for both population growth increase and habitat carrying capacity.

Table 8 . Summary of Assessment Endpoints and Measures of Ec ological Effects

Assessment Endpoint Surrogate Species and Measures of Ecological Effect 1 Measures of Exposure

Birds 2 Survival Bobwhite quail acute oral LD 50 Bobwhite quail and mallard duck subacute dietary LC 50 Predicted peak residues

in wildlife food items Reproduction and growth Bobwhite quail and mallard duck

reproduction NOAEC

Mammals Reproduction

and growth Laboratory rat reproduction

NOAEC and NOAEL

Survival Laboratory rat acute oral LD 50

Freshwater fish 3 Survival Rainbow trout and bluegill sunfish

acute LC 50 Peak EEC 4

Reproduction and growth Freshwater fish reproduction NOAEC 60

- day average EEC 4

Freshwater

invertebrates Survival Water flea acute EC 50 Peak EEC 4

Reproduction and growth Water flea reproduction NOAEC 21

- day average EEC 4

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

Estuarine/marine
invertebrates Survival Eastern oyster acute EC 50 and mysid

acute LC 50 Peak EEC 4

Benthic invertebrates Survival Amphipod acute LC 50 and midge

acute LC 50 Peak EEC 4

Reproduction and growth Midge NOAEC 21

- day average EEC 4

Aquatic plants and algae Survival and

growth Algal (green algae) and vascular plant

(duckweed) EC 50 and NOAEC values for growth rate and biomass

measurements Peak EEC 4

1 If species listed in this table represent most commonly encountered species from submitted studies, risk assessment guidance indicates most sensitive species tested within taxonomic group are to be used for baseline risk assessments.

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

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

4 Based on standard pond estimates of aquatic EECs.

5 Four species of two families of monocots

- one is corn, six species of at least four dic ot families, of which one is soybeans.



## 7.0 Conceptual Model

7.1 Risk Hypothesis

The EPA will employ the following risk hypothesis when assessing ecological risks of the use of buprofezin:

### 21

Buprofezin, when used in accordance with current labels, may result in contamination of ecosystems and adverse effects upon the survival, growth, and reproduction of non

- target terrestrial and aquatic organisms, including organisms that are Federally

- listed as threatened and endangered species.

7.2 Conceptual Diagram

The po tential exposure pathways and effects of buprofezin are depicted for aquatic environments

in Figure 2 and for terrestrial environments in Figure 3

.

Figure 2

. Conceptual model depicting stressors, exposure pathways, and potential effects to aquatic animals and plants from the use of buprofezin. Dotted lines depict exposure routes that

are e xpected to be insignificant.

### 22

Figure 3

. Conceptual model depicting stressors, exposure pathways, and potential effects to terrestrial animals and plants from the use of buprofezin. Dotted lines depict exposure routes that

a re expected to be insignificant.



## 8.0 Analysis Plan

In registration review, pesticide ecological risk assessments will follow the EPA ’s Guidelines for Ecological Risk Assessment, will be in compliance with the paper titled “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency” (“Overview Document”) (January 2004), a nd will be done in accordance with Section 7 of the Endangered Species Act (US EPA, 2004).

8.1 Stressors of Concern

The EPA does not routinely include, in its risk assessments, an evaluation of mixtures of active ingredients, either those mixtures of multiple active ingredients in product formulations or those in the applicator’s tank. In the case of the product formulations of multiple active ingredients (that is, a registered product containing more than one active ingredient), each active ingredient is subj ect to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing more than one active ingredient, they may be used qualitatively or qu antitatively in accordance with the

### 23

EPA ’s Overview Document and the Services’ Evaluation Memorandum (U.S., EPA 2004; USFWS/NMFS 2004).

Eleven degradation products of buprofezin have been identified. Neither environmental fate nor ecological effects data for the degradation products have been submitted. However, OPP’s Health Effects Division (HED) concluded that the only residue of conce rn is parent buprofezin. Therefore, ecological risk and drinking water assessments conducted in registration review will focus only on the parent compound.

8.2 Measures of Exposure

In order to estimate risks of buprofezin exposures in aquatic and terres trial environments, all exposure modeling and resulting risk conclusions will be based on registered labels including maximum application rates and methods cited earlier for each use of buprofezin. Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations (EECs) of buprofezin.

The model used to predict terrestrial EECs on food items is T

- REX. Three models are used to to derive EECs relevant to terrestrial and wetland plants

. TerrPlant is used to e stimate exposure to terrestrial plants from runoff from treated sites, whereas AgDrift and AgDisp are used to estimate exposure to terrestrial plants from spray drift . See the following web site for furt her information

on these models: http://www.epa.gov/oppefed1/models/terrestrial/index.htm

.

8.2.1 Aquatic Exposure and Modeling Input Parameters

The appropriate input parameters are selected from the environmental fate data and in accordance

with USEPA

- OPP

- EFED water model parameter selection guidelines. Potential aquatic exposures

will be estimated using the Tier II models Pesticide Root Zone Model (PRZM v3.12.2, May 12, 2005) and Exposure Analysis Modeling System (EXAMS v2.98.04.06, April 25, 2005) coupled with the input shell pe5.pl ( Nov. 16, 2006). PRZM simulates fate and transpo rt of pesticides on the agricultural field and EXAMS simulates the fate and resulting daily concentrations of pesticides that reach an adjacent water body through runoff, erosion, and spray drift. Simulations are based on crop

- specific scenarios developed to represent environmental conditions at sites at high runoff

- vulnerability for pesticide transport to surface waters from a particular crop. Exposure

is estimated using a standard pond scenario based on a 10

- ha field bordering a 1

- ha water body , 2

- m deep ( 20,000 m 3 

### ) with no outlet. Using appropriate scenarios linked with local meteorological data, the model is run for 30 years with the reported EECs representing the values that are expected once every ten years, based on the thirty years of daily values gen erated during the

simulation. A dditional information about model assumptions and uncertainties, input guidance,

and scenario metadata are available at the EPA’s water modeling website, http://www.epa. gov/oppefed1/models/water/

.

The environmental fate values to be used for modeling are summarized in Table 9

. Pesticide specific inputs used are the estimated 90 percent upper bound value of the first

- order kinetics

aerobic soil metabolism half

- lives (T 1/2 

### = 168 days; the 90 % 

### upper

- bound on mean), a maximum

### 24

aquatic photolysis half

- life (T 1/2 

### = 38 days), the lowest non

- sand K d 

### value of 69 mL/g, and 16% spray drift (aerial application). Because the aerobic aquatic metabolism rates are not known it is estimated (as 336 days) using EFED guidance (taking the upper 90 percent half

- life for aerobic soil metabolism and multiplying it by 2).

Table 9 . Summary of model input parameters used for assessing aquatic exposure

Fate Property Value Model used

Molecular Weight 305.4 EXAMS

Henry’s constant 6.73 x 10
- 6 atm

- m 3 /mole EXAMS

Vapor Pressure 6.4 x 10
- 6 mm Hg at 25 C EXAMS

Solubility in Water 0.382 mg/L at 25 C EXAMS

Photolysis in Water 38 days EXAMS

Aerobic Soil Metabolism Half

- life 168 days (90% upper bound on mean)

68.75 days (mean) PRZM
SCI

- GROW 1

Anaerobic Soil Metabolism Half

- life No data EXAMS

Hydrolysis stable @ pH = 7 EXAMS

Aerobic Aquatic Metabolism 336 ( 2 * 168) EXAMS

Anaerobic Aquatic Metabolism Stable EXAMS

Kads 69 PRZM/ EXAMS

Koc 2791 SCI

- GROW 1

Spray Drift 0.16

– aerial; 0.064 ground EFED guidance

Application Efficiency 0.95;

- aerial 0.99

– ground EFED guidance

1 

### http://www.epa.gov/oppefed1/models/water/scigrow_description.htm

8.2.2 Monitoring Data for Surface Water

No surface or ground water monitoring data were found for buprofezin. Sources checked include

the U.S Geological Service National Water Quality Assessment database (NAWQA, 2007), the USGS/EPA Reservoir Monitoring Program (Blomquist et al., 2001), the California Department of Pesticide Regulation Surface Water Database (DPR, 2006), the National Stream Qual ity Accounting Network database (NASQAN, 2006), the USDA Pesticide Data Program (PDP) surface water monitoring program, and the USEPA STORET database of water quality
parameters.

8.2.3 Terrestrial Exposure

Exposure to terrestrial animals and plants will be assessed for general crop groups to represent all uses of buprofezin. For each crop group, exposure will be quantitatively assessed based on

### 25

restrictions on the product labels for the maximum application rate, maximum seasonal use rate,

maximum number of applications allowed per season, and minimum reapplication interval, as given in Figure 1

. Buprofezin Usage by Crop Reporting District (2006

- 2010). (US EPA , 20 1 2 ).

For all crops, buprofezin products are registered for foliar application using either ground equipment or aircraft. Buprofezin is registered for ultra low volume (ULV) applicati on on tomato and ornamental plants. Application of buprofezin through irrigation systems (i.e., chemigation) is prohibited. Labels of buprofezin products contain no restrictions that would prevent application to the crops during bloom. The label for NNI

- 0871 SC (Vetica Insecticide, EPA Reg. No. 71711

- 32), which contains flubendiamide as well as buprofezin, requires that a 15

- ft buffer zone be maintained between the treated field and any aquatic habitat. Products containing buprofezin

alone do not hav e buffer zone requirements. Table 2 below, summarizes the currently registered uses of buprofezin and application information for each crop or use site.

Table 2

. Since all buprofezin products are applied only as foliar spray, EPA will use its standard methodology for assessing terrestrial exposure based on consumptions of contaminated food items on sprayed use sites. The current version of the Terrestrial Residue Exposure Model (T

Rex) will be used to estimate maximum concentrations of buprofezin active ingredients on various types of on wildlife food items, including short grass, broadleaf plants, fruit, seeds, and insects. For uses involving a single application, the maximum concentration will be the initial concentration immediately following spraying, and for uses with multiple applications allowed, the maximum concentration will be the predicted peak application of accumulated residues, taking into account diss ipation. The peak concentrations from multiple applications will be modeled assuming a reasonably conservative (slow) rate of dissipation based on data available from submitted studies on magnitude of residue, reduction of residue, and foliar dissipation f or registered uses on appropriate commodities, such as leafy vegetable crops . If these studies do not provide adequate data to estimate the foliar dissipation half

- life for buprofezin, then the division’s default value of 35 days will be assumed.

The T

- Rex model assesses risk to birds and mammals based on dietary exposure. Dietary exposure then will be assessed for animals which are assumed to consume each of the various terrestrial food types, assuming that 100% of their diet consists of contaminated fo od of a single type. EPA has used the Screening Tool for Inhalation Risk (STIR, Version 1.0) and the Screening Imbibition Program (SIP, version 1.0) to screen for the potential for registered uses of buprofezin to result in significant exposure through in halation and drinking water. Because of the low volatility and solubility of buprofezin, relative to its toxicity, these models have found that exposure through drinking water and inhalation will not significantly contribute to the exposure or

risk to te rrestrial birds and mammals. Therefore, these routes of exposure will not be included in

the assessment of risk to terrestrial wildlife . While the terrestrial risk assessment will be conducted for risk to birds and mammals, the risk conclusions will be pre sumed to be protective of reptiles and terrestrial phases of amphibians as well.

The T

- Rex model does not predict exposure to terrestrial insects. Because buprofezin is highly toxic to immature developing insects, exposure to larvae and pupae stages of bees and other insect pollinators is a concern. Exposure to immature stages of insect may occur when adult insects forage on treated fields and carry nectar and/or pollen back to feed developing young. Therefore, to assess exposure to terrestrial insect pollinator, EPA will seek information in the open literature on residues buprofezin in the nectar, pollen, honey, and bee bread. If such information is not

### 26

available, EPA may request additional data to measure exposure and effects to bees from use of bupr ofezin.

EECs for terrestrial plants inhabiting upland and wetland areas will be derived using TerrPlant. This model uses estimates of pesticides in runoff and in spray drift to calculate EECs. EECs are based upon solubility, application rate and minimum incorporation depth in addition to type of formulation and method of application. Two spray drift models, AGDisp and AgDRIFT, are used to assess exposures of terrestrial plants to buprofezin deposited in terrestrial habitats by spray

drift.

Exposure wil l also be assessed for piscivorous (fish

- eating) terrestrial wildlife which feed on aquatic organisms, such as the bald eagle. Exposure and risk to piscivorous wildlife feeding on aquatic organisms will be assessed using the current version of the KABAM m odel ( http://www.epa.gov/oppefed1/models/water/#kabam ). Guidance for this model recommends using the model for non

- ionic organic compounds for which the log of the octanol

- water partition coefficient (log K
ow 

### ) is between 4 and 8. The log K
ow 

### for buprofezin at 20oC is 4. 31

.

8.3 Measures of Effect

Ecological effects data are used as measures of direct and indirect effects to biological receptors.

Measures of effects to animals with acute e xposure are the LD 50 

### and LC 50 

### , or for aquatic invertebrates, an EC 50 

### based on immobility. Measures of effects to animals from chronic exposure are the NOAEL or NOAEC for based on observable lethal and sublethal effects. Toxicity endpoints used to measure effects to terrestrial plants are the IC 25 

### for nonlisted species

and either the NOAEL or IC 05 

### for listed species.

Data are obtained from registrant

- submitted studies and/or from literature studies identified by ECOTOX. The ECOTOX database provides more ecological effects data in an attempt to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was

created and is maintained by EPA, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory's Mid

- Continent Ecology Division.

Information on the potential effects of buprofezin on non

- target animals is also collected f rom the Ecological Incident Information System (EIIS; USEPA, 2007 c ). The EIIS is a database containing adverse effect (typically mortality) reports on non

- target organisms where such effects have been associated with the use of pesticides. Incidents repo rted in the aggregate incident reports and the Avian Incident Monitoring System (AIMS) will also be searched. AIMS is a database administered by the American Bird Conservancy (partially funded by EPA). It contains publicly available data on reported avia n incidents involving pesticides ( http://www.abcbirds.org/abcprograms/policy/pesticides/aims/aims/index.cfm ). Finally, the Incident Data System (IDS), a component of the PRISM database maintained by ITRMD, is also

a source of incident information.

Where available, sub

- lethal effects observed in both registrant

- submitted and open literature studies will be evaluated qualitatively. Such effects may include behavioral c hanges ( e.g. ,

### 27

lethargy and changes in coloration). Quantitative assessments of risks, though, are limited to those endpoints that can be directly linked to the EPA ’s assessment endpoints of impaired survival, growth and reproduction.

The assessment of ri sk for direct effects to non

- target organisms makes the assumption that toxicity of buprofezin to birds is similar to terrestrial

- phase amphibians and reptiles. The same assumption is made for fish and aquatic

- phase amphibians.

8.4 Integration of Exposure a nd Effects

Risk characterization is the integration of exposure and ecological effects characterization to determine the potential ecological risk from the use of buprofezin and the likelihood of direct and

indirect effects to non

- target organisms in aqua tic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on

non

- target species. For the assessment of buprofezin risks, the risk quotient (RQ) method is used
to compa re exposure and measured toxicity values. EECs are divided by acute and chronic toxicity values. The resulting RQs are then compared to the EPA ’s Levels of Concern (LOC) (USEPA, 2004). These criteria are used to indicate when buprofezin’s use, as direct ed on the labels, has the potential to cause adverse direct or indirect effects to non

- target organisms. In addition, incident data from EIIS, incident data system reports, and AIMS will be considered as part of the risk characterization.

When calculati ng risk quotients (RQ’s) for aquatic invertebrates, EFED typically compares acute toxicity endpoints with the peak predicted water concentration of the pesticide, whereas chronic

invertebrate life

- cycle toxicity endpoints are typically compared with a pred icted water concentration averaged over 21 days. The 21

- day average EEC is typically used to match the duration of exposure encountered in the laboratory effects testing. However, the inhibition of chitin synthesis during specific stages of larva l develo pment is considered an acute event that requires only a short

- term exposure during the specific stage of development (Touart and Rao, 1987; MRID 44460702 ) . Risk assessment for other chitin

- synthesis inhibitors, such as diflubenzuron, have therefore calcu lated chronic RQs using the acute peak EEC rather than the

21

- day average EEC (e.g. Section 3 Registration Request for Uses of Diflubenzuron on Pears, Stone Fruits, Tree Nuts, Peppers, and Pasture Grass (Chemical # 108201, DP Barcode D279732, D279735, D278 770). EPA plans on using this approach in calculating chronic RQs for the effects of buprofezin on aquatic invertebrates.

8.5 Endangered Species Assessment

Consistent with the EPA ’s responsibility under the Endangered Species Act (ESA), the EPA will

evaluat e risks to Federally

- listed threatened and/or endangered (listed) species from registered uses of buprofezin. Risk assessments will be conducted i n accordance with the Overview Document (USEPA, 2004), provisions of the ESA, and the Services’ Endangered Sp ecies
Consultation Handbook (USFWS/NMFS, 1998).

### 28

8.6 Drinking Water Assessment

OPP/ EFED has recently finaliz ed a new human health drinking water exposure assessment (DWA) for buprofezin on for the proposed uses of buprofezin, requested by IR

- 4, on leafy brassica vegetables, turnip greens, and persimmon and expanding use to the full crop subgroup for fruiting vegetables, except non

- bell pepper (Group 8

- 10); citrus fruit (Group 10

- 10), pome fruit (Group 11

- 10), and succulent bean

. (See 275100 D 395217 and D3 93932 New Uses DWA

, issued April 5, 2012 )

. This new DWA reconfirms the EDWC values calculated previously (See
275100 D360583 Amended DWA

, issued January 12, 2009). Using the PRZM/EXAMS 2 

### model to estimate potential concentrations in water, t he highest

, peak , surface water concentration value
is 58.2 μg/L , and the 1

- in

- 10 year average (chronic) EDWC is 18.6 μg/L , based on the Puerto
Rico coffee scenario

. For citrus, the highest

, peak , surface water concentration value is 57.1 μg/L

, and the 1

- in

- 10 year averag e EDWC is 12.4 μg/L , based on the Florida citrus scenario . Using
SCI

- GROW 1 

### model to estimate potential residues in groundwater, the concentration value for
both citrus and coffee is 0.09 μg/L

. Therefore, this assessment reconfirms that the estimated
drinki ng water concentrations (EDWC) previously calculated for the reduced application rate on coffee continue to produce the highest EDWC.

Two Tier II screening level Drinking Water Assessments ha d been previously conducted for buprofezin uses at the maximum rate (DP Barcode D339828 dated January 7, 2008 and D343066 dated April 23, 2008). Surface water EDWCs for all modeled uses are listed below in Table 8

. EDWCs ranged from 4.5 to 58.2 ppb for acute exposure in su rface water and from 1.5 to 18.6 ppb for chronic exposure. Groundwater EDWCs do not reflect site

- specific environments or agricultural practices other than application rates, so all uses with the maximum application rate share the highest values. The proposed use on olives, as well as cu rrently registered uses on citrus, peaches, and pears, all lead to acute and chronic groundwater EDWCs of 0.09 ppb

.

` Table 8

. Summary of Previous Human Health Drinking Water EDWCs for Buprofezin

Table 8. Tier II EDWCs in surface water drinking water s ources resulting from application of buprofezin.

Use PRZM Scenario 1

- in

- 10 year acute (ppb) 1

- in

- 10 year chronic

(ppb) 30

- year average

(ppb)

Strawberry CA strawberry 11.0 3.0 2.1

FL strawberry 11.2 3.8 2.9

Low

- growing

berries OR berry 4.5 1.5 1.3

GA peach 6.5 1.7 1.3

MI cherry 11.6 4.2 3.1

CA wine grape 13.1 3.6 2.6

Olive CA olive 7.0 3.5 2.6

Leafy vegetables CA row crop 9.6 2.6 2.0

FL pepper 16.1 4.3 3.1

CA lettuce 19.1 6.4 4.5

2 For additional information o n the PRZM/EXAMs and SCI

- GROW models, refer to http://www.epa.gov/pesticides/science/models_pg.htm#aquatic

.

### 29 FL tomato 20.4 5.0 3.7

Cranberries a N/A 47.9 N/A N/A

Coffee PR coffee 58.2 18.6 13.6

Citrus FL citrus 57.4 12.5 9.1

a Modeled using Tier I Rice Model v. 1.0.



### 8.7 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxici ty, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its reregistration decision

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), buprofezin is subject to the end ocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect p roduced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal system s will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and

es tablish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the EPA must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Buprofezin is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EP A will issue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for buprofezin. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines an d the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.



## 9.0 Clean Water Act

### 30

Buprofezin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 3 

### . In addition, no Total Maximum Daily Loads (TMDL) have been developed for buprofezin 4 

### . More information on impaired water bodies and

TMDLs can be found at the EPA ’s website 5 

### . The EPA invites submission of water quality data

for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and
Other Water Quality Data in OPP’s Registration Review Risk Assessment and Mana gement
Process 6 

### in order to ensure they can be used quantitatively or qualitatively in pesticide risk

assessments.



## 10.0 Anticipated Data Needs

The EPA does foresee requiring additional fate and ecological effects studies prior to conducting the planned assessments. Data gaps, uncertainties and potential paths forward for the assessment of buprofezin are described below.

10.1 Environmental Fate

The followi ng information is needed in order to conduct the planned assessments. According to EPA records, these studies have never been submitted for review:

835.4300 Aerobic Aquatic Metabolism 835.6100 Environmental Chemistry Method and Independent Laboratory Va lidation

- soil 835.6200 Environmental Chemistry Method and Independent Laboratory Validation

- water

Additional data are requested to upgrade the storage stability data of the Terrestrial Field Dissipation study (MRID 44394044, Guideline 835.6100) from "Upg radable" to "Acceptable" in

accordance to the Subdivision N Guidelines.

10.2 Ecological Effect

s

EPA anticipates that the following additional ecological effects studies are needed to characterize risk for buprofezin in the upcoming risk assessment f or Regist ration Review. S ee Appendix A for a complete listing of the current status of data requirements.

850.1350 Chronic Toxicity with the Mysid

The methodology used in the mysid life

- cycle toxicity test (47676702) deviated significantly from the methodology recommended by the 850 test guidelines. Significant deficiencies of the study

include no measurement of time to first brood and measurements of length which were not recorded by gender. In addition, measurements of test concentrations over time showed high variability in all treatment levels (CV of 26

- 38%). While uncertain, the results of this study do

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

4 http://iaspub.e pa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES

5 http://www.epa.gov/owow/tmdl/

6 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

### 31

indicate greater toxicity than does earl ier invertebrate life

- cycle testing with a freshwater waterflea ( Daphnia magna ), and thus may change the previous conclusions of low chronic risk to aquatic invertebrates. Furthermore, the chronic toxicity of buprofezin to the mysid cannot be

estimated wi th available data using the acute

- to

- chronic ratio method because the acute toxicity endpoints for the mysid and the waterflea are nondefinitve. Therefore, a new life

- cycle test with the mysid is needed.

Chronic Sediment Toxicity with Freshwater Benthic Invertebrate s
Because buprofezin is persistent, binds to sediment, may reach aquatic habitats, and exhibits

toxic ity to aquatic invertebrates, obtaining good information on the toxicity of buprofezin to

sediment

- dwelling invertebrates is important for characterizing ecological risk. The chemical meets all of the EPA criteria for requesting chronic sediment toxicity tes ting. The chemical has

been shown to have half

- lives greater than 10 days in both the terrestrial environment (aerobic

soil half

- lives 36.5

- 101 days, MRID 44394042) and the aquatic environment (stable under anaerobic aquatic metabolism conditions, MRID 44 394043). The chemical also meets all of the physical chemistry triggers for chronic sediment toxicity testing (K d 

### >50, log K
ow 

### >3, and

K
oc 

### >1000). Chronic testing may be requested when any one of these physical chemistry triggers

are met.

The registrants h ave submitted two 28

- day subchronic stud ies on the effects of buprofezin on the emergence of the midge, Chironomus riparius , one with spiked water (MRID 46597901) and one with spiked sediment (MRID 47676703). However, these studies were done according to the OECD guidelines (OECD guidelines 218 and 219), which differs substantially from the OCSPP test guidelines for acute and chronic sediment toxicity testing. Differences include the test species, the duration of exposure, and the toxicity endpoints measu red. Because of these

substantial differences , the submitted study is not acceptable for fulfilling any test requirements for testing toxicity of buprofezin to benthic organisms. Nevertheless, the study was adequate to demonstrate that buprofezin has rel atively low toxicity to Chironomus sp. with short

- term exposure. MRID47676703 provided evidence that the 10

- day LC 50 

### of developing midges exposed to spiked water exceeds 5.54 mg ai/L. As t his provides adequate data for assessing acute toxicity to sedimen t

- dwelling invertebrates

, additional 10

- day sediment toxicity tests with a freshwater species (Guideline 850.1735) and a saltwater species (Guideline 850.1740) will not

needed.

The observation of relatively low acute toxicity to benthic invertebrates agre es with studies with other aquatic crustaceans that show buprofezin is much more toxic on a chronic basis than on an

acute basis. An acute test with the waterflea found the 48

- hr EC 50 

### to be greater than 420 μg ai/L (MRID 42873833), whereas a chronic test with the same species established an NOAEC at 80 μg ai/L (MRID 44435901). Similarly, an acute test with the grass shrimp found the 96

- hr LC 50 

### to be greater than 560 μg ai/L (MRID 44394020), whereas a life

- cycle study with the mysid (another

saltwater crus tacean) established an NOAEC at 22.5 μg ai/L (MRID 47676702). The life

- cycle studies with the water flea (MRID 44435901), as well as supplemental life

- cycle studies with the fathead minnow (MRID 42873834 and 48083904), found that the most sensitive endpoi nts were reproductive measures such as percent egg hatching and number of young produced. The m uch greater toxicity observed in chronic studies relative to acute studies is also consistent with the mode of action of buprofezin, the inhibition of chitin sy nthesis. Chronic testing with the

### 32

sediment

- dwelling invertebrates (OCSPP in prep. Guidelines 850.1760, 850.1770, and 850.1780) are therefore needed as these are the only sediment toxicity guideline which measures reproductive endpoints.

Maximum concen trations expected in pore water were compared to results of the supplemental

28

- day Chironomus toxicity study to determine if expected environmental concentrations are toxicologically relevant. Modeling with PRZM and EXAMS, based on the scenario for use o f buprofezin on citrus in Florida, determined that the maximum EEC for pore water to be 14.4 μg.

In the 28

- day Chironomus toxicity study with spiked sediment (MRID476767

- 03), the measured pore water concentration associated with the NOAEC ( at the test lev el with an overlying water concentration of 2.8 mg/L) was 21 μg/L. Since this EEC is greater than 1/10 the NOAEC of the

28

- day study, expected environmental concentrations are at toxicologically relevant levels where significant chronic effects may occur.

Chronic sediment testing with three benthic invertebrates is recommended to ensure protection of all benthic invertebrate species which may be exposed to buprofezin. The three test species the EPA recommends for chronic sediment toxicity testing are a f reshwater midge ( Chironomus

dilutes or C. tentans ), the freshwater amphipod Hyaella azteca , and the saltwater amphipod Leptocheirus plumulosus . Testing of the freshwater midge is needed because it is an egg

- laying insect, and thus likely would have similar sensitivity to buprofezin as target species. Furthermore, as stated above, 28

- day testing with Chironomous riparius indicates that expected environmental concentrations are at toxicologically relevant for Chironomous species. Testing with a freshwater and a saltwater amphipod are also desired to determine the sensitivity of these divergent taxonomic groups to chronic toxicity of buprofez i n. However, chronic tests with freshwater and saltwater amphipods would not be needed if data could be provided which demonstrates that these groups of organisms are no more sensitive to buprofezin than the freshwater midge, or that the chronic risk assessment for aquatic crustaceans inhabiting overlying water, based on chronic

toxic ity data for the waterflea ( Daphnia magna ) and the mysid ( Americamysis bahia ) , would be protective of sediment

- dwelling crustaceans.

850.1500 Fish Life

- Cycle Toxicity, Freshwater or Saltwater Species

The methodology of the fish life

- cycle study with a fat head minnow (MRID 48083904) had relatively minor deviations from the test guideline, but the study failed to establish an NOAEC for reproductive effects, and the reproductive results were confounded by very inconsistent reproductive performance among the r eplicate test vessels. At lower concentrations, some replicates showed very poor reproduction while others showed reproduction similar to that observed in the control. One replicate in the control also showed very poor reproduction. Because of this, the study author concluded that the reproductive results were “inconclusive.” However, the statistically significant reduction in egg production and percent spawning observed

at all treatment levels cannot be discounted. A high

- quality fish life

- cycle study is critical for risk

assessment because life

- cycle testing with the waterflea and the mysid indicate that reproductive toxicity is the most sensitive endpoint . Furthermore , comparison of the results of the supplemental

fish life

- cycle study with th ose of the fish early life

- stage study (MRID 44394021) suggest that

life

- cycle test is a more sensitive for detecting chronic effects of buprofezin. Therefore, a new

fish life

- cycle study is needed to establish the fish chronic NOAEC. This study may be cond ucted with either a freshwater or a saltwater fish species.

### 33

Special Study: Honey Bee Larvae Feeding Study

In an attempt to address protection of pollinators, EPA is anticipating needing data to assess the potential hazard to insect pollinators from exposu re to buprofezin. In this assessment, the honeybee (

Apis mellifera ) will likely be used as a surrogate for all insect pollinators. In moving forward with addressing potential risk to these organisms, EPA will consider the recommendations of the Society o f Environmental Toxicology and Chemistry (SETAC) Workshop on Pesticide Risk Assessment for Pollinators and the FIFRA Science Advisory Panel, and will be working with its federal and state partners, industry, and academia to determine appropriate assessment methodology. For compounds such as buprofezin, which is (1) known to be toxic to insects and (2) known to have exposure routes to bees, the EPA is requesting toxicity and exposure studies to allow for evaluation of risks to pollinators. The study of Mom maerts et al. (2006) provide evidence that buprofezin is toxic to reproduction and development of the honeybee, although the exact level of exposure of the bees in this study is uncertain (see Section 4.2). The potential for exposure of bees and other ins ect pollinators to buprofezin is believed to be significant because it is used on many flowering crops which are attractive to pollinators, including fruit trees, berries, grapes, fruiting vegetables, and ornamental plants. Furthermore, the product labels do not prohibit application during times when the crops are in bloom.

At this time, the most important gap in the understanding of the potential risk of buprofezin to insect pollinators is the toxicity of the compound to larval stages. Therefore, EPA anticipates the need for a bee larvae study with buprofezin. As there is not currently an OCSPP guideline for conducting a bee larvae test, the registrant is requested to consult with the EPA on the proposed protocol to be used prior to conducting the study. The published method of Aupinel et al . (2007)

is recommended as an ex ample of a protocol for this type of study.

The EPA will evaluate the need for higher tier toxicity testing of buprofezin after reviewing results of the bee larvae toxicity study and other available data, such as residues of buprofezin in plant parts. Hi gher

- tiered testing may include field or semi

- field honey bee studies and studies that measure residues in nectar and pollen of treated crops. EPA will consider the recommendations of the SETAC workshop on Pesticide Risk Assessment for Pollinators and the FIFRA Scientific Advisory Panel in deciding on the type of testing needed and the test protocols which should be used. At this time, however, the need for higher

- tier toxicity testing with insect pollinators is not anticipated for buprofezin because it i s not a systemic insecticide and evidence does exist not indicate that its use poses a serious hazard to pollinators

.

Data call

- in justification tables are provided for the special studies which are needed. S ee Appendix A for a complete listing of the current status of data requirements for ecological effects.

### 34

Data Call

- In Justification Tables

Guideline Number: 835.4300 (Aerobic Aquatic Metabolism)

Rationale for Requiring the Data 

### Buprofezin has a moderate capacity for sorption (binding) to soils and therefore can enter shallow or deep surface waters by such routes as direct application, spray drift,

run

- off, and/or through attachment to eroding soil. The conditions in natural aquat ic sediment systems are often aerobic in the upper water phase. The surface layer of sediment can be either aerobic or anaerobic, whereas the deeper sediment is usually anaerobic. An aerobic aquatic test simulates an aerobic water column over an aerobic

se diment layer that is underlain with an anaerobic gradient. This study is used for chemicals which are directly applied to water or which are likely to reach the aqueous environment by the routes described above. This study is also required for uses such as aquatic food crop, aquatic nonfood outdoor, aquatic nonfood industrial, aquatic nonfood residential and forestry. Practical Utility of the Data

How will the data be used? Aerobic aquatic metabolism data is used to estimate the rate by which the pesticide will disappear from aquatic environmental through the route of metabolism by microbiota in the

water.

How could the data change the Agency’s decision, or impact the Agency ’s future decision

making? Aerobic aquatic metabolism data is required as an input to EFED environmental fate and transport surface water and groundwater models. Having this data will eliminate the need to use conservative default values in the modeling.

Guideline Number: 835.6100 (Environmental Chemistry Method and Independent Laboratory Validation Only)

– Soil

Guideline Number: 835.6200 (Environmental Chemistry Method and Independent Laboratory Validation Only)

- Water

Rationale for Requiring the Data Independently validated analytical methods for residues in soil, water, sediment, and plant material (environmental chemistry methods) submitted by the registrant are used to evaluate analyses described in submitted environmental fate and ecological effects studies. Submitted analytical methods are also used by various federal, state, tribal, and local agencies to detect and monitor residues that are or are suspected to be in environmental compartments due to outdoor

uses and accidental releases. In dependent laboratory validations for submitted analytical methods are necessary to confirm that the methods are functional and to confirm the levels of detection and quantitation reported in registrant

- prepared validations.

Use of buprofezin may impact te rrestrial or aquatic environments due to residues of concern

### 35

during the application process. Therefore, outside agencies may request analytical methods with which to monitor for buprofezin residues of concern in soil and water. An independently validated environmental chemistry method for buprofezin residues in soil and one for water have not been submitted by the registrant. Validated environmental chemistry methods and independent laboratory validations of the methods are required to support monitoring for buprofezin residues and to evaluate newly submitted environmental fate and ecological effects data.

Practical Utility of the Data

How will the data be used? In the absence of independently validated environmental chemistry methods, submitted environmental fate and ecological effects data may not be reviewable and entities outside the

EPA may lack chemical

- specific methods for analyses in environmental compartm ents. Independently validated environmental chemistry methods will be used to evaluate newly submitted environmental fate and ecological effects data and will be made available for enforcement and monitoring purposes at the federal, state, and local level s.

How could the data change the Agency’s decision, or impact the Agency’s future decision

making? Risk assessment conclusions could be altered if they are not supported by either study data or environmental monitoring detections that are based on indep endently validated environmental chemistry methods. Furthermore, while not directly related to EPA decision

- making, independently validated environmental chemistry methods are necessary to ensure the safety of those in proximity to releases of buprofezin residues in the environment.

No chronic whole sediment toxicity data for freshwater or saltwater invertebrates are available. 40 CFR 158 conditionally requires whole sediment chronic toxicity data for freshwater and estuarine/marine invertebrates. Buprofezin meets conditions for requiring these data based on high persistence (aerobic soil and aquati c metabolism half

- lives > 10 days) and based on physical

- chemical properties associated with high binding to sediment (K d >50, log K

ow >3, and K

oc >1000). Furthermore, a life

- cycle study with the water flea, as well as supplemental life

- cycle studies with th e fathead minnow, found that the most sensitive endpoints were reproductive measures such as percent egg hatching and number of young produced. Chronic tests with the sediment

- dwelling invertebrates are therefore needed as these are the only sediment toxi city tests which measures reproductive endpoints.

Current EFED recommendations for freshwater sediment testing follow Agency

- wide guidance stated in

Test Method 100.4:

“ Hyalella azteca 42

- d Test for Measuring the Effects of Sediment Associated Contaminants on Survival, Growth, and Reproduction” contained in USEPA 2000 Methods for Measuring the Guideline Number: Non

- guideline study (OCSPP 850.1770, in prep.), use test method 100.4 (citation included in text). Study Title: Whole Sediment: Chronic Toxicity to Freshwater Invertebrate

- Examining Survival, Growth, and Reproduction for Hyaella azteca

. Rationale for Requiring the Data

### 36

Toxicity and Bioaccumulation of Sediment

- associated Contaminants with Freshwater

Invertebrates EPA 600/R

- 99/064 (OCSPP 850.1770)

.

A protocol should be submitted for approval prior to testing. Based on test variability for the endpoints of concern and the need to establish a NOAEC/LOAEC the following number of replicates and test animals

are rec ommended for the freshwater amphipod H. azteca : 12 replicates per treatment (4 for 28

- d survival and growth and 8 for the remainder of the test) with 10 neonates per replicate.

In the absence of data, toxicity will be estimated using the lowest chronic t oxicity endpoint for freshwater invertebrates and the estimated pore water concentrations in sediment. This does not consider possible exposure via ingestion or contact with contaminated sediment, and therefore would be uncertain.

The requested data woul d allow EPA to estimate chronic risks to benthic invertebrates, including defining an effect area for endangered species. Risk mitigation strategies, such as determining the maximum application rate at which the RQ would not exceed the LOC, cannot be eval uated without these data. Practical Utility of the Data

How will the data be used?
The data would allow the EPA to determine chronic risk to benthic freshwater invertebrates from buprofezin in water and sediment. The effects data would be used to determine the likelihood that the chronic risks can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision

- making? Risk assessment and mitigation strategies, such as determining the maximum application rate that results in RQs that do not exceed the LOC, cannot be evaluated without these data. If future endangered species risk assessments are performed without these data, the EPA would have to assume that buprofezin “may affect” endangered freshwater benthic invertebrates directly (and endangered species from other taxa indirectly), and use of buprofezin might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the EPA and registrants have in coming into compli ance with the Endangered Species Act and could result in use restrictions for buprofezin which are unnecessarily severe.

No chronic whole sediment toxicity data for freshwater or saltwater invertebrates are available. 40 CFR 158 conditionally requires whole sediment chronic toxicity data for freshwater and estuarine/marine invertebrates. Buprofezin meets conditions for requiring these data based on high persistence (aerobic soil and aquati c metabolism half

- lives > 10 days) and based on physical

- chemical properties associated with high binding to sediment (K d >50, log K

ow >3, and K

oc >1000). Furthermore, a life

- cycle study with the water flea, as well as supplemental life

- cycle studies with th e fathead minnow, found that the most sensitive endpoints were reproductive measures such as percent egg hatching and number of young produced. Chronic tests with the sediment

- dwelling invertebrates are therefore needed as these are the only sediment toxi city tests which measures reproductive endpoints.

Current EFED recommendations for freshwater sediment testing follow Agency

- wide guidance stated in Guideline Number: Non

- guideline study (OCSPP 850.1760, in prep.), use test method 100.5 (citation included in text). Study Title: W hole Sediment: Chronic Toxicity to Freshwater Invertebrates

- Examining Survival, Growth, and Reproduction for Chironomus dilutus or C. tentans

. Rationale for Requiring the Data

### 37

Test Method 100.5:

“Life

- cycle Test for Measuring the Effects of Sediment

- associated Contaminants on Chironomus
dilutus or C. tentans ” contained in USEPA 2000 Methods for Measuring the Toxicity and
Bioaccumulation of Sediment

- associated Contaminants with Freshwater Invertebrates EPA 600/R

99/064 (OCSPP 850.1760)

.

A protocol should be submitted for approval prior to testing. Based on test variability for the endpoints of concern and the need to establish a NOAEC/LOAEC the following number of replicates and test animals are recommended for the midge test with C. di lutus or C. tentans : 16 replicates per treatment containing 12 test organisms each (12 replicates at test initiation; 4 added at 10 days for auxiliary males).

In the absence of data, toxicity will be estimated using the lowest chronic toxicity endpoint f or freshwater invertebrates and the estimated pore water concentrations in sediment. This does not consider possible exposure via ingestion or contact with contaminated sediment, and therefore would be uncertain.

The requested data would allow EPA to est imate chronic risks to benthic invertebrates, including defining an effect area for endangered species. Risk mitigation strategies, such as determining the maximum application rate at which the RQ would not exceed the LOC, cannot be evaluated without thes e data. Practical Utility of the Data

How will the data be used?
The data would allow the EPA to determine chronic risk to benthic freshwater invertebrates from buprofezin in water and sediment. The effects data would be used to determine the likelihood that the chronic risks can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision

- making? Risk assessment and mitigation strategies, such as determining the maximum application rate that results in RQs that do not exceed the LOC, cannot be evaluated without these data. If future endangered species risk assessments are performed without these data, the EPA would have to assume that buprofezin “may affect” endangered freshwater benthic invertebrates directly (and endangered species from other taxa indirectly), and use of buprofezin might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the EPA and registrants have in coming into compli ance with the Endangered Species Act and could result in use restrictions for buprofezin which are unnecessarily severe.

No chronic whole sediment toxicity data for freshwater or saltwater invertebrates are available. 40 CFR 158 conditionally requires whole sediment chronic toxicity data for freshwater and estuarine/marine invertebrates. Buprofezin meets conditions for requiring these data based on high persistence (aerobic soil and aquatic metabolism half

- lives > 10 days) an d based on physical

- chemical properties associated with high binding to sediment (K d >50, log K

ow >3, and K

oc >1000). Furthermore, a life

- cycle study with the water flea, as well as supplemental life

- cycle studies with the fathead minnow, found that the most sensitive endpoints were reproductive measures such as percent egg hatching and number of young produced. Chronic tests with the sediment

- dwelling invertebrates is therefore needed as these are the only Guideline Number: Non

- guideline study (OCSPP 850.1780, in prep.), use citation included in text. Study Title: Whole Sediment: Chron ic Toxicity to Saltwater Invertebrates

- Examining Survival, Growth, and Reproduction for Leptocheirus plumulosus

. Rationale for Requiring the Data

### 38

sediment toxicity tests which measures reproductive endpoints.

Current EFED recommendations for freshwater sediment testing follow Agency

- wide guidance stated in:

“Method for Assessing the Chronic Toxicity of Marine and Estuarine Sediment

- associated Contaminants with the Amphipod Leptocheirus plumulosus EPA 600/R

- 01/020 (OCSPP 850.1780).

A protocol should be submitted for approval prior to testing. In the absence of data, toxicity will be estimated using the lowest chronic toxicity endpoint for saltwater invertebrates and the estimated pore water concentrations in sediment. This does not consider possible exposure via ingestion and could underestimate risk for some invertebrates where ingestion is an important exposure pathway; therefore, there will be considerable uncertainty in risk concl usions.

In the absence of data, toxicity will be estimated using the lowest chronic toxicity endpoint for freshwater invertebrates and the estimated pore water concentrations in sediment. This does not consider possible exposure via ingestion or contact with contaminated sediment, and therefore would be uncertain.

The requested data would allow EPA to estimate chronic risks to benthic invertebrates, including defining an effect area for endangered species. Risk mitigation strategies, such as determining the maximum application rate at which the RQ would not exceed the LOC, cannot be evaluated without these data. Practical Utility of the Data

How will the data be used?
The data would allow the EPA to determine chronic risk to benthic saltwater invertebrates from buprofezin
in water and sediment. The effects data would be used to determine the likelihood that the chronic risks can potentially impact aquatic communities, either by direct effects or by indirect effects on other organisms by reducing their food sources.

How could the data impact the Agency’s future decision

- making? Risk assessment and mitigation strategies, such as determining the maximum application rate that results in RQs that do not exceed the LOC, cannot be evaluated without these data. If future endangered species risk assessments are performed without these data, the EPA would have to assume that buprofezin “may affect” endangered saltwater benthic invertebrates directly (a nd endangered species from other taxa indirectly), and use of buprofezin might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the EPA and registrants have in coming into complian ce with the Endangered Species Act and could result in use restrictions for buprofezin which are unnecessarily severe.

### 39

Study Title: Acute Honey Bee Larvae Feeding Study

Guideline Number: 

### Non

- guideline Rationale for Requiring the Data 

### While buprofezin has low toxicity to adult bees, the mode of action (chitin biosynthesis inhibitor) suggests that it is likely much more toxic to larval stages. A published study demonstrated toxic effects of buprofezin to developing bumblebees ( Bombus terrestris ) (Momma erts et al. 2006). Buprofezin is sprayed to the foliage of many flowering crops which are attractive to bees, and thus foraging bees are expected to collect contaminated food (pollen and nectar) from treated plants and carry residues back to the hive, whe re developing larval stages could be exposed. Furthermore, environmental fate properties indicate that residues of buprofezin will persist in the terrestrial environment for weeks to months. Because of the potential for pollen and nectar to be contaminat ed with buprofezin, it is important to determine the toxicity of this compound to pollinator larvae. The registrant should consult the EPA on the design of the protocol prior to the initiation of the study. Practical Utility of the Data

How will the data be used? 

### This study would allow EPA to refine the screening level risk assessment for beneficial terrestrial arthropods, including insect pollinators. The effects data will be used to determine the potential for hazard to insect pollinators through direc t effects on the larvae. The toxicity levels measured in this study would be compared to residue levels expected in nectar and pollen from treated crops to assess risk. How could the data change the Agency’s decision or impact the Agency’s future decisi on
- making? 

### Toxicity testing with adult bees indicate that buprofezin is not a hazard to adult insect pollinators; however, since buprofezin is more toxic to developing larval stages than to the adults, an assessment based on toxicity to bee larvae may reveal a risk to nontarget beneficial insects, and this risk could warrant imposing label warnings or other risk mitigation measures. In addition, bee larvae toxicity data could impact EPA’s decisions on whether or not use of buprofezin is likely to jeopa rdize the continued existence of endangered or threatened species of terrestrial arthropods.

### 40



## 11.0 References

Aupinel, P., D. Fortini, B. Michaud, F. Marolleau, J

- N Tasei and J

- F Odoux. 2007. Toxicity of dimethoate and fenoxycarb to honey bee brood (Apis mellifera), using a new in vitro standardized feeding method. Pest Management Science 63: 1090

– 1094.

Blomquist, J.D. and J.M. Denis, J.L. Cowles, J.A. Hetrick, R.D. Jones, N.B. Birchfield. 2001.

Pesticides in Selected Water

- Supply Reservoirs and Fi nished Drinking Water, 1999

- 2000: Summary of Results from a Pilot Monitoring Program. USGS Open File Report 01

- 456. Sacramento, CA

Burns, L. A. 2002. EXAMS (Exposure Analysis Modeling System) Version 2.98.04. (Compiled 07/18/04). Environmental Resea rch Laboratory., U. S. Environmental Protection Agency. Athens, GA.

Carsel, R. F., J. C. Imhoff, P. R. Hummel, J.M. Cheplick, and A.S. Donigian, Jr. 1998. PRZM

- 3, Version 3.12 beta (Compiled (05/24/01). A Model for Predicting Pesticide and Nitrogen

Fate in the Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0. United State Environmental Protection Agency. Athens, GA.

DPR. 2007. Surface Water Database. California Environmental Protection Agency, Department of Pesticide Regulation, Surfac e Water Protection Program. Available at: http://pestreg.cdpr.ca.gov/docs/sw/surfdata.htm. Accessed December, 2007.

Environmental Fate and Effects Division. 2002. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II. U. S. Environmental Protection Agency. Washington, D.C. http://www.epa.gov/oppefed1/models/water/input_guidance2_28_02.htm/

IRAC. 2011. IRAC MoA Classification buprofezin. Version 7.1. IRAC International MoA Working Group. 23 pp. Available online at: http://www.irac

- online.org/wp

- content/uploads/2009/09/MoA_ Classification.pdf

Jones, R.D. et al., 2000. Guidance for use of the Index Reservoir and Percent Crop Area Factor in Drinking Water Assessments (March 21, 2000). Office of Pesticide Programs, Environmental Fate and Effects Division, U.S. Environmental P rotection Agency. Arlington, VA.

Kikuchi, M., Y. Sasaki, and M. Wakabayashi. 2000. Screening of organophosphate pollution in water by using Daphnia magna

. Ecotoxicology and Environmental Safety . 47:239

- 245.

Lyman WJ, Reehl WF, Rosenblatt DH. 1990. Han dbook of Chemical Property Estimation Methods: Environmental Behavior of Organic Compounds. American Chemical Society, Washington, DC, USA.

Mommaets, V., G. Sterk, and G. Smagghe. 2006. Hazard and uptake of chitin synthesis

inhibitors in bumblebees Bombus terrestris

. Pest Management Science . 62:752

- 758.

### 41

NASQAN. 2007. National Stream Quality Accounting Network. United States Geological Survey. Available at: http://water.usgs.gov/nasqan/. Accessed December, 2007.

NAWQA. 2007. USGS National Water Qua lity Assessment Data Warehouse. United States Geological Survey. Available at: http://infotrek.er.usgs.gov/traverse/f?p=NAWQA:HOME:3765519528892019. Accessed December, 2007.

Office of Pesticide Programs. 2000. Drinking Water Screening Level Assessments. http://www.epa.gov/oppfead1/trac/science/reservoir.pdf

.

USEPA. 1999. Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessments. Arlington, VA.

USEPA. 2000. Drinking Water Screening Level Assessment. Part A: Applying a Percent Crop Area Adjustment to Tier II Surface Water Model Estimates for Pesticide Drinking Water Exposure Assessments. FQPA Science Policy Document .Public Comment Draft September 1, 2000. Federal Re gister: October 11, 2000 (volume 65, number 197). Electronic copy available at http://www.epa.gov/pesticides/trac/science/ .

USEPA. 2002a. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II (February 28, 2002). Office of Pesticide Programs, Environmental Fate and Effects Division, U.S. Environmental Protection Agency. Arlington, VA.

U.S. EPA. 2002b. Pesticide Root Zone Model (PRZM) Field and Orchard Crop Scenarios:

Standard Procedures for Conducting Quality Control and Quality Assurance. Office of Pesticide Programs, Environmental Fate and Effects Division, U.S. Environmental Protection Agency. Arlington, VA.

USEPA. 2002b. Pesticide Root Zone Model (PRZM) Field and Orchard Crop Scenarios : Standard Procedures for Conducting Quality Control and Quality Assurance. Office of Pesticide Programs, Environmental Fate and Effects Division, U.S. Environmental Protection Agency. Arlington, VA.

U.S. EPA. 2003b. Use of Regional Percent Crop Area Fact ors in Refined Drinking Water Assessments. US EPA Office of Pesticide Programs (OPP), Environmental Fate and Effects Division (EFED), Water Quality Technical Team (WQTT). Arlington, VA

USEPA

. 2003c. SCI

- GROW 2.3: Windows Version of SCI

- GROW. September 30, 2003. Office of Pesticide Programs, Environmental Fate and Effects Division, U.S. Environmental Protection Agency. Arlington, VA.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs . United States Environm ental Protection Agency (USEPA). Environmental

### 42

Fate and Effects Division. Office of Pesticide Programs. Available at http://www.epa.gov/espp/consultation/ecorisk

- overview.pdf

.

USEPA. 2012. Buprofezin Usage Map by Crop Reporting District (PC Code: 275100)

. Memorandum from Biological and Economical Analysis Division to the Environmental Fate and Effects Division. April 26, 2012.

### 43 APPENDIX A

DATA REQUIREMENTS FOR 

## Buprofezin

PC Code: 129032

Data Requirement Use

Pattern 1 Does EPA Have

Data To Satisfy This Requirement?
(Yes, No, or Partially) Bibliographic

Citation Must Additional

Data Be Submitted
Under FIFRA 3(c)(2)(B)?

§158.630 WILDLIFE AND AQUATIC ORGANISMS

850.2100/71

- 1(a) Acute Avian Oral, Quail/Duck 1,2,3 Yes 42872827

42873828 No

850.2100 Acute Avian Oral, Passerine 1,2,3 No No 2

850.2200/71

- 2(a) Avian Dietary, Quail 1,2,3 Yes 42873830 No

850.2200/71

- 2(b) Acute Dietary, Duck 1,2,3 Yes 42873829 No

850.2300/71

- 4(a) Avian Reproduction, Quail 1,2,3 Yes 44394013 No

850.2300/71

- 4(b) Avian Reproduction, Duck 1,2,3 Yes 44394014 No

850.1075/72

- 1 (a) Acute Freshwater Fish, Bluegill 1,2,3 No 44394015,

42873831 No 3

850.1075/ 72

- 1(c) Acute Freshwater Fish, Trout 1,2,3 No 44394016

42873832 No 3

850.1010/ 72

- 2(a) Acute Freshwater Invertebrate 1,2,3 Yes 42873833 No 3

850.1075/72

- 3(a) Acute Estuarine/Marine, Fish 1,2,3 Yes 44394018 No 3

850.1025/72

- 3(b) Acute Estuarine/Marine, Bivalve

850.1055 1,2,3 Yes 44394019 No

850.1035/72

- 3(c) Acute Estuarine/Marine, Crustacean
850.1045 1,2,3 Yes 44394020 No 3

850.1400/72

- 4(a) Fish Early

- Life Stage Fish 1,2,3 Yes 44394021 No

850.1300/72

- 4(b) Freshwater Invertebrate Life Cycle 1,2,3 Yes 44435901

42873835 No

850.13 5 0/72

- 4(b) Saltwater Invertebrate Life Cycle 1,2,3 No 47676702 Yes 4

850.1500/72

- 5 Fish Life Cycle 1,2,3 No 48083904

42873834 Yes 4

850.1710/165

- 4 Fish BCF 1,2,3 Yes 44394047 No

850.1735 Whole Sediment Acute Invertebrate,

Freshwater 1,2,3 No 47676703

46597901 No 5

850.1740 Whole Sediment Acute Invertebrate, Marine 1,2,3 No No 5

850.1 60 (in prep) Whole Sediment Chronic Freshwater Invertebrate, Chironomus dilutes 1,2,3 No Yes

### 44

Data Requirement Use

Pattern 1 Does EPA Have

Data To Satisfy This Requirement?
(Yes, No, or Partially) Bibliographic

Citation Must Additional

Data Be Submitted
Under FIFRA 3(c)(2)(B)?

850.170 (in prep) Whole Sediment Chronic Freshwater Invertebrate, Hyalella azteca 1,2,3 No Yes 6

850.180 (in prep) Whole Sediment Chronic Marine/Estuarine Invertebrate, Leptocheirus plumulosus 1,2,3 No Yes 6

§158.660 PLANT PROTECTION

850.4100/122

- 1(a) Seedling Emergence, Tier 1 1,2,3 Yes 44394036 No

850.4150/122

- 1(b) Vegetative Vigor, Tier 1 1,2,3 Yes 44394037 No

850.4100/123

- 1(a) Seedling Emergence, Tier 2 No

850.4150/123

- 1(b) Vegetative Vigor, Tier 2 No

850.4400/122

- 2 Aquatic Plant Growth, Vascular Plant,

Tier 1 1,2,3 No 44394038 No 3

850.5400/122

- 2 Aquatic Plant Growth, Algae, Tier 1 1,2,3 No 44394039 No 3

850.4400/123

- 2 Aquatic Plant Growth, Vascular Plant,

Tier 2 No

850.5400/123

- 2 Aquatic Plant Growth, Algae, Tier 2 No

§158.630 NONTARGET INSECT TESTING

850.3020/141

- 1 Honeybee Acute Contact 1,2,3 Yes 44394040 No

850.3030/141

- 2 Honeybee, Residues on Foliage No

850.3040/141

- 5 Field Test for Pollinators No

Special Study: Honey Bee Larvae Toxicity 1,2,3 No Yes 7

§158.1300 ENVIRONMENTAL FATE

Degradation Studies

— Lab

835.2120/161

- 1 Hydrolysis 1,2,3 Yes 44394041 No

835.2240/161

- 2 Photodegradation In Water 1,2,3 Yes 44463102 No

835.2410/161

- 3 Photodegradation On Soil 1,2,3 Yes 44453903 No

Metabolism Studies

— Lab

835.4100/162

- 1 Aerobic Soil 1,2,3 Yes 44394042 No

835.4200/162

- 2 Anaerobic Soil No

835.4300/162

- 3 Anaerobic Aquatic 1,2,3 Yes 44394043 No

835.4400/162

- 4 Aerobic Aquatic 1,2,3 No No data w ere submitted Yes

Mobility Studies

835.1230/163.1 Leaching

- Adsorption/Desorption

835.1240 1,2,3 Yes 42990601 No

### 45

Data Requirement Use

Pattern 1 Does EPA Have

Data To Satisfy This Requirement?
(Yes, No, or Partially) Bibliographic

Citation Must Additional

Data Be Submitted
Under FIFRA 3(c)(2)(B)?

835.1410/163

- 2 Volatility (Lab) Yes No

Dissipation Studies

— Field

835.6100/164

- 1 Terrestrial 1,2,3 Yes 44394044 No

835.6200/164

- 2 Aquatic (Sediment) No

FOOTNOTES:

1. 1=Terrestrial Food; 2=Terrestrial Feed; 3=Terrestrial Non

- Food; 4=Aquatic Food; 5=Aquatic Non

- Food(Outdoor);6=Aquatic Non

- Food (Industrial);7=Aquatic Non

Food (Residential);8=Greenhouse Food; 9=Greenhouse Non

- Food;10= Forestry; 11=Residential Outdoor; 12=Indoor Food; 13=Indo or Non

- Food; 14=Indoor Medicinal;15=Indoor Residential.

2. Acute toxicity testing with a passerine species is not needed because existing acute toxicity data, as well as the mode of ac tion of buprofezin, indicate that the acute toxicity of buprofezin to vertebrates is low.

3. All acute aquatic toxicity studies, except for the oyster shell deposition study, were classified as supplemental because the study reports did not indicate that the analysis conducted to measure test concentrations were filtered prior to analysis to remove suspended solids, making the concentration dissolved test material uncertain. Nevertheless, the studies were sufficient to show that no mortality occurs at the solubility limit of buprofezin. Therefore, no additional acute aqua tic toxicity testing is required.

4 . The study(studies) submitted for this guideline is (are) classified as supplemental and does not provide adequate informat ion to characterize the chronic toxicity. A new study for this guideline is needed.

5 . The two supplemental studies provided do not fulfill the test guideline but are sufficient to characterize the acute toxicity of buprofezin to sediment

- dwelling

invertebrates.

6

. These studies may not be needed if data are provided which demonstrates that th ese test organisms are no more sensitive to buprofezin than the freshwater midge, or that the chronic risk assessment for aquatic crustaceans inhabiting overlying water, based on chronic toxicity data for the w aterflea ( Daphnia magna ) and the mysid ( Americ amysis bahia ) , would be protective of sediment

- dwelling crustaceans.

7. Although this guideline has been fulfilled, a special study is needed to provide data on the toxicity of buprofezin to honeyb ee larvae.

8. A laboratory study on v olatility is not required because existing data on the vapor pressure and Henry’s Law Constant of buprofezin indicate that it has low volatility.

### 46

Appendix B . Proposed Degradation Pathways for Buprofezin in Soil(s), Water (w) and Light (l).

### 47 Appendix C. Names and Chemical Structures of Buprofezin and

Major Transformation Products

PARENT COMPOUND

Buprofezin

2

- tert

- butylimino

- 3

- isopropyl

- 5

- phenyl

- 1, 3,5

- thiadiazin

- 4

- one

MAJOR DEGRADATES (≥10%)

BF

- 12

N

- (l

- methylethy1)

- N’

- phenylurea

BF

- 21

N

- phenylformamide

BF

- 25

N

- [[(1, l

- dimethylethyl)amino]thioxomethyl]

- N

- (1

- methyleyl)

- N’

- phenylea; thiobiuret