UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460



### PC C odes : 028869
DP B arcode : 429606
D ate : December 2 , 2015
MEMORANDUM

SUBJECT: Problem Formulation for the Ecological Risk and Drinking Water Exposure
Assessments to b e Conducted For the Registration Review of Fluoxastrobin

To: Bilin Basu, Chemical Review Manager Jill Bloom, Team Leader Linda Arrington, Chief Risk Management and Implementation Branch V
Pesticide Re

- evaluation Division

FROM: Rochelle F. H. Bohaty, Ph.D., Chemist
Environmental Risk Branch 3 Environmental Fate and Effects Division (7507P)

THROUGH: Dana Spatz, Branch Chief
Environmental Risk Branch 3 Environmental Fate and Effects Division (7507P)

PEER REVIEW: Melissa Panger, Ph.D., Science Advisor
Environmental Risk Branch 2 Environmental Fate and Effects Division (7507P)

Rosanna Louie

- Juzwiak, RAPL
Environmental Risk Branch 3
Environmental Fat e and Effects Division (7507P)

This memo transmits the Problem Formulation for the ecological risk and drinking water

e xposure a ssessments to be conducted for the Registration Review for fluoxastrobin

.

### 2



# Contents

I. Executive Summary

................................ ................................ ................................ ........................ 3
II. Introduction

................................ ................................ ................................ ................................ .. 4
1. Previous Ecological Risk Assessments

................................ ................................ ............................ 4
2. Drinking Water Exposure Assessments

................................ ................................ .......................... 5
3. Clean Water Act Programs

................................ ................................ ................................ ............. 6
III. Stressor Source and Distribution

................................ ................................ ................................ .... 7
A. Description of Stressors

................................ ................................ ................................ ................. 7
B. Mechanism of Action

................................ ................................ ................................ ..................... 8
C. Ove rview of Pesticide Usage

................................ ................................ ................................ .......... 8
1. Label Uncertainties

................................ ................................ ................................ ......................... 9
A. Environmental Fate and Transport

................................ ................................ .............................. 19
IV. Receptors

................................ ................................ ................................ .............................. 26
A. Ecological Incidents

................................ ................................ ................................ ...................... 30
B. E xposure Pathways of Concern

................................ ................................ ................................ .... 30
V. Analysis Plan

................................ ................................ ................................ ................................ 31
A. Ecological Risk Assessment

................................ ................................ ................................ .......... 31
1. Stressors of Concern

................................ ................................ ................................ .................... 31
2. M easures of Exposure

................................ ................................ ................................ .................. 31
3. Measure of Effects

................................ ................................ ................................ ....................... 32
4. Integration of Exposure and Effects

................................ ................................ ............................. 32
5. Endangered Species Assessments

................................ ................................ ................................ 32
6. Endocrine Disruptor Screening Program

................................ ................................ ...................... 33
B. Drinking Water

................................ ................................ ................................ ............................. 33
VI. Preliminary Identification of Data Gaps

................................ ................................ .................. 33
A. Environmental Fate

................................ ................................ ................................ ...................... 33
B. Eco logical Effects

................................ ................................ ................................ .......................... 33
VII. References (general)

................................ ................................ ................................ .............. 55
AP PENDIX A. CHEMICAL IDENTIFICATION OF FLUOXASTROBIN TRANSFORMATION PRODUCTS

.......... 56
APPENDIX B. SIP ANALYSIS RESULTS

................................ ................................ ................................ 58
APPENDIX C. STIR ANALYSIS RESULTS

................................ ................................ ............................... 60

### 3

I. EXECUTIVE S UMMARY

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation (attached) for the ecological risk and drinking water exposure assessments to be conducted as part of the Registration Review of the str obilurin fungicide fluoxastrobin (PC 028869). This document is intended to provide an overview of what is currently known regarding the environmental fate and ecological effects associated with fluoxastrobin and its transformation products, and outlines

un certainties regarding attributes of the se compound s. It describes the preliminary ecological risk hypothesis and the processes that will be used during the completion of the preliminary ecological risk assessment in support of Registration Review. Uncertai nties unique to the risk assessment of
fluoxastrobin are also discussed.

A bibliography that includes the study classification for all of the studies that have been submitted to support the registration of fluoxastrobin is included in the data requirement table at the end of this
document

. EFED recommends requesting the following additional data to better understand the
environmental fate and ecological effects to support the current registrations of fluoxastrobin :

• An independent la boratory validation for fluoxastrobin in water to support the environmental chemistry method (MRID 45865331) ;

A s noted in previous risk assessments, f luoxastrobin has a borderline high Kow and is not expected to rapidly degrade via anaerobic metabolism. In addition, several fate studies have shown fluoxastrobin readily partitions to sediment it is observed to be persistent. Therefore, fluoxastrobin is expected to partition to the sediment where it may persist. Due to the toxicity of fluoxastrobin to other aquatic animals, benthic organisms may also be at risk and t oxicity data are not available to assess such a risk.
This i s consistent with the 2011 EFED guidance. 1



### • Whole Sediment: Chronic Invertebrates Freshwater and Marine (O CSPP 850.1770; O CSPP 850.1760 or OECD 218): A 28

- day spiked sediment study will reduce risk assessment uncertainties regarding freshwater and estuarine/marine sediment

- dwelling organisms.

To date, the conclusions for potential risk to honey bees are based solely on acute ora l and contact toxicity tests for adults. The full Tier I suite of honey bee data is not available but is needed for parent
fluoxastrobin (TGAI, unless otherwise noted below). Based on the new guidance 2 

### for assessing risk to bees the following studies are n eeded:

• Honey Bee Larvae A cute O ral S tudy (Non

- guideline / OECD TG237, Tier 1).

• Honey B ee L arvae Chronic O ral T oxicity S tudy (Non

- guideline, Tier 1).

• Honey B ee A dult Chronic O ral T oxicity S tudy (Non

- guideline, Tier 1)

.

• Semi

- field Testing for Pollinators U sing TEP ( Non

- guideline / OECD 75, Tier 2)

• Field Trial of Residues in P ollen and N ectar using TEP ( Non

- guideline, Tier 2)

• Field Testing for Pollinators U sing TEP ( OCSPP 850.3040, Tier 3)

1 U.S. EPA OCSPP Series 850 Guideline Numbers to Reference when Requesting a Whole Sediment Chronic Toxicity Test, January 20, 2011

2 U.S. EPA Guidance and Implementation of Exposure and Effects Testing for Assessing Risks to Bees, March 18,
2014

### 4

II. INTRODUCTION

Conclusions of the previous assessments are summarized in Table II

. 1 and additional details are provided in the subsections below.

Table II

. 1

. Summary of Previous Risk Concerns a 

### Identified for Fluoxastrobin

Exposure

Basis Birds Mammals Terrestrial
Plants Terr.
Inverts. (honey

bee hazard) Fish Aquatic
Inverts Aquatic
Plants Mobile Persistence Degradates
of Concern

Acute No b No No No Yes Yes No Yes c Yes None Chronic Yes Yes No Yes

a. At least one LOC has been exceeded in previous assessments
b. U ncertain due to lack of data ( e.g. , passerine data not used at time of risk assessment ) ; however, data on other avian species suggest the likelihood of effect is limited.

c. slightly to moderately mobile



### 1. Previous Ecological Risk Assessments

Seven ecological risk assessments have been completed for the regist ration of fluoxastrobin for use on agricultural crops and non

- cropped areas

. Uses assessed include peanut, potato and tuber vegetables, leaf petioles subgroup, fruiting vegetables, turf, and seed treatments for potato, peanut and turf (D028869), field and seed corn, low

- growing berries, soy bean, sweet corn and wheat (D356983, D357729, D366187), squash/cucumber and in

- furrow and banded uses on tuberous and corm vegetables as well as peanut ( D379112, D384375 ), melon and sorghum ( D403574 ), rice ( D392988 ).
Several of the assessment are abbreviat ed drawing conclusions based on similar use patterns previously

assess ed

. Conclusions of the previous assessments are summarized in Table II

. 2

. The only residue of

concern evaluated in these assessment is fluoxastrobin . Based on available data for a variety of taxa, fluoxastrobin is expected to be considerabl y more toxic to non

- targ et species than its environmental

t ransformation products.

Table II

. 2

. Summary of Previous Risk Assessments Conducted on Fluoxastrobin

Use Reference/

Year Completed Maximum Application Rate Assessed (lb a.i./A) Conclusions

Peanut, potato,

t uber vegetables

,

leaf petioles, fruiting vegetables, turf
and seed
treatments for
potato, peanut, and turf D028869 July 2 9

,

2004

Revised

D312237 February 10, 2005 0.55 (single application) 2.2 (yearly application) Risk was identified for estuarine/marine invertebrates, mollusk, listed freshwater fish, and
freshwater invertebrates.

Low

- growing berries, soybean, Risk was identified for estuarine/marine invertebrates, mollusk, listed freshwater fish, listed

### 5

field and seed

corn D356983, D357729,
D366187 July 17,

2009 0.18 (single application) 0.72 (per year) freshwater invertebrates, birds and mammals. However, no risk was identified to terrestrial plants estuarine/marine fish and aquatic plants. Sweet corn and
wheat

Squash/Cucumber
and In

- furrow and

banded uses on

tuberous and corm vegetables and peanut D379112,
D384375
January 10,
2011 0.18 (single application) 0.72 (per year)

Ornamental D349270,
D349282
August 29,
2008 0.55 (single application)

2.2 (yearly application) Risks identified are the same as those previous ly identified for the same as previously identified for the same application rate.

Rice D392988
May 8,
2012 0.18 (single application) 0.36 (per year) Risk was identified for freshwater fish , freshwater invertebrates, estuarine/marine invertebrates, listed

non

- vascular aquatic plants. However, risk to

terrestrial organisms (animals and plants) estuarine/marine fish, and vascular aquatic plants
were not identified.

Melon and sorghum D403574 March 19,
2013 Risks for use on melon (0.18 lb a.i./A single application; 0.72 lb a.i./A per year) are the same as those previously identified for cucurbits. Risks for use on sorghum (0.12 lb a.i./A; 0.24 lb a.i./A) are the same as those identified
for wheat.

Field Corn (seed

treatment) D415725, D417151,
D417733 No level of concern (LOC) exceedances for seed treatment; Risks identified
are the same as those previous ly identified for the same annual application

rate of 0.36 lb a.i./A.



### 2. Drinking Water Exposure Assessments

Several drinking water assessments (DWA) have been completed for fluoxastrobin including for use on peanut, potato and tuber vegetables, leaf petioles subgroup, fruiting vegetables, turf; and seed treatments for potato, peanut, a nd turf (D289104)

, field and seed corn, low

- growing berries, and soybean (D356984, D357669), sweet corn and wheat (D366189 )

, Squash/Cucumber (crop subgroup 9B)
and New In

- Furrow and Banded Uses on Tuberous and Corm Vegetables (crop subgroup 1C) as well as

Peanut (D379114, D384377)

, melon and sorghum (D403757), rice (D401613, D 392990 )

. The only residue
of concern considered in the se drinking water assessments i s fluoxastrobin

. The highest estimated drinking water concentrations (EDWCs) are residues in groundwater resulting from turf applications.

Table II

. 3 . Summary of Previous Drinking Water Assessments

Use Reference / Year Completed Models
Used Estimated Surface Water Concentrations (μg/L) a Estimated Groundwater
Concentrations b (μg/L)

1

- in

- 10 year Peak 1

- in

- 10 year
Annual Mean 30 Year
Mean Peak Post Breakthrough Average Peanut, potato,

t uber D289104 a FIRST, SCI

GROW 71 28 <1 μ g/L

### 6

vegetables , leaf petioles, fruiting vegetables, turf
and seed
treatments for
potato, peanut, and turf November 23, 2004

Low

- growing
berries

, soybean , field
and seed corn D356984,
D357669 June 18,

2009 PRZM

EXAMS,
SCI

- GROW 23.7 17.0 11.9

Sweet corn and
wheat D366189 b PRZM

EXAMS,
SCI

- GROW 38 30 14

Squash/Cucumb
er and In

- furrow

and banded

uses on tuberous and

corm v egetables and p eanut D379114,
D384377 c PRZM

EXAMS,
SCI

- GROW 61 53 24

Rice D392990,
D401613 Tier 1 Rice 93 0.038 0.23

Melon and sorghum D403757 d PRZM

EXAMS,
PRZM

- GW 49 19 12

146 137 Field Corn (seed

treatment) D415725, D417151,
D417733 PRZM

- GW Not referenced

a. Estimations based on turf use (4 x 0.55 lbs ai/A @ 21 day interval, ground application)
b. Estimations based on turf use (4 x 0.55 lbs ai/A @ 14 day interval, ground application)

c. Updated turf EDWCs reflect new input parameter guidance
d. Estimations based on turf use (4 x 0.55 lbs ai/A @7 day interval, ground application)



### 3. Clean Water Act Programs

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

### No Total Maximum Daily Load (TMD L) criteria have been developed

. 4 

### The EPA invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quali ty 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 Management Process 5 

### in order to ensure the data can be used quantitatively or qualitatively in pesticide risk assessments.

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

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_polluta nt_group_name=PESTICIDES

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

### 7

Aquatic benchmarks have not been established for fluoxastrobin

. 6 

### Any data submitted or otherwise located as part of the registration review process may be used to establish aquatic life benchmarks if applicable.

III. STRESSOR SOURCE AND DISTRIBUTION

A. Description of Stressors

The chemical structure of fluoxastrobin along with the chemical identification and select physical

chemical properties are provided i n Table III

. 5

. In addition to the technical grade products [ fluoxastrobin ( 264

- 1137 and 66330

- 65 ), there are nine fluoxastrobin registered end

- use prod ucts ( 264

- 1169

, 66330

- 64

, 66330

- 379

, 66330

- 380 and 66330

- 383, 66330

- 388, 66330

- 407, 66330

- 409, 66330

- 424

. Of the nin e end

- use products five contain other active ingredients ( Table III

. 2 )

. Environmental t ransformation products of fluoxastrobin include HEC 5725

- oxazepine

, HEC 5725

- phenoxy

- amino

- pyrimidine

, HEC 5725

- E

- des

- chlorophenyl (HEC 7155)

, HEC 5725

- 4

- hydroxyphenyl and HEC 5725

- amide (HEC 7338.), EC 5725

- des

- chlorophenyl carboxylic acid (HEC 7334), and HEC 5725

- carboxylic acid (HEC 7180). A dditional information on these transformation products is included in the Environmental Fate Section of this
document as well as in A ppendix B

. The only residue of concern is fluoxastrobin.

Table III

. 1

. Chemical Identification and Physical Chemical Properties of Fluoxastrobin

Common Chemical Name Fluoxastrobin Company Code HEC5725

Chemical Name [(1E)

- [2

- [[6

- (2

- Chlorophenoxy)

- 5

- fluoro

- 4

- pyrimidinyl]oxy]phenyl] 5,6

- dihydro

1,4,2

- dioxazin

- 3

- yl) methanone

- O

- methyloxime] CAS Registry Number 361377

- 29

- 9 [E

- isomer]

Chemical Structure 

### O

N N O N O O N

C l F

O
C H 3

Molecular Formula C 21 H 16 ClFN 4 O 5 SMILES NOTATION C1=NC(=C(C(=N1)OC2=C(C=CC=C2)Cl)F)OC3=C(C=CC=C3) \ C(=N/OC)C4=NOCCO4 Molecular Mass (g/mol) 458.83 Vapor Pressure (25 °C) 4.23 x 10

- 12 torr (5.63 x 10

- 10 Pa at 20 and 8.72 x 10

- 10 Pa at 25)

Water Solubility ( m g/L;

2 0 °C) pH 4: 2.431 pH 7: 2.292 pH 9: 2.292 unbuffered: 2.559

Henry’s Law Constant 1.01 x 10

- 7 Pa m 3 / mole (9.98 atm

- m 3 /mol ) Log K ow ( 20 °C) 2.86 pKa

- 2.1 (estimated) Most data were obtained from product chemistry submitted for technical fluoxastrobin submission (MRID 45865303)

6 http://www.e pa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm ; http://www2.epa.gov/pesticide

science

- and

- assessing

- pesticide

- risks/aquatic

- life

- benchmarks

- pesticide

- registration

### 8

Table III

. 2

. Multiple Active Ingredient Formulations of Fluoxastrobin

Formulation

Reg. No. Percent (%)
Fluoxastrobin in
Formulated End

- Use Product Other Active Ingredient; Percent (%)
in Formulated End

- Use Product

66330

- 379 2.44 Chlorothalonil;
38.4

66330

- 383 18 Tebuconazole;
25

66330

- 388 18 Myclobutanil ; 25.6

66330

- 407 14.84 Flutriafol ; 19.3

66330

- 424 17.76 Tetraconazole ; 17.76



### B. Mechanism of Action

Fluoxastrobin is a “leaf

- systemic” strobilurin fungicide. Strobilurin fungicides (Q o 

### I family) are site

- specific compounds that provide significant control of plant diseases caused by pathogens. These compounds work by interfering with respiration in plant

- pathogenic fungi. This is done by binding th e Q o 

### - centre on cytochrome b block ing electron transfer between cytochrome b and cytochrome c1. This disrupts the energy cycle within the fungus by halting the production of ATP. Strobilurin fungicides also have

t ranslaminar activity, therefore, enabling movement through treated leaves providing control on leaf surfaces. Fluoxastrobin is also shown to be effective in inhibiting spore germination and mycelial growth.

C. Overview of Pesticide Usage

Fluoxastrobin was first registered in the United States on September 20, 2005 . It is curre ntly registered
for use on berries, corn, fruiting vegetables, leafy vegetables, melons, ornamentals, peanuts, potato, rice, sorghum, soybeans, squash/cucumber, tuber/corm vegetables, turf (commercial/institutional lawns, golf course, ornamental, sod farms, residential lawns), and wheat.

Most products are formulated as a flowable, emulsifiable or soluble concentrate ; ho wever, there is one granular product (Reg. 66330

- 380) and one water dispersible granule product (Reg. No. 66330

- 407). Application types include seed treatment, broadcast (aerial and ground), chemigation , ground band
treatment, drench and in

- furrow

.

Bas ed on current labels, the maximum single application rate ranges from 0.006 to 2.0 pounds of active ingredient per acre (lb a.i./acre) . U p to four applications per year is allowed for some uses ; however, it
should be noted that for several uses the number of application s per year is not specified. A complete
list of all current fluoxastrobin uses and how EFED currently understands the uses is presented in Table

III

. 3

. This table was developed based on the label data information provided to EFED by Biological Economic Analysis Division (BEAD).

### 9

Based on the BEAD chemical profile for Registration Review 7 

### , b etween 200 8

- 2013 , 33,000 pounds of active ingredient were applied on average annually to 363,000 acres. According to the BEAD Screening Level Usage Analysis (SLUA) 8 

### , between 2004

- 2013 , the average percent crop treated (PCT) for all crops (corn, peanuts, peppers, potatoes, soybean, and wheat) screened <2.5% . The highest average annual pounds a.i. applied was 10,000 lb active ingredient to corn , soyb eans, and whea t.

Approximately 20,000 lbs active ingredient of fluoxastrobin was reportedly used in the professional turf management and horticultural and horticultural segments.



### 1. Label Uncertainties

For some terrestrial uses, the number of applications of fluoxastrobin that can be applied per calendar year or the maximum annual application rate for a given use is not explicitly stated on many of the
current labels. See Table III

. 3 for specifics. Assumptions that will be made in absence of label
clarific ations are provided in brackets in the aforementioned table

.

7 Yourman, L., Doucoure, C. Berwald, D. BEAD Chemical Profile for Registration Revi ew: Fluoxastrobin (028869) May 13, 2015

8 Yourman, Leonard, Doucoure, C., Berwald, D., Fluoxastrobin Label Use Report Package in Support of Registration Review, June 10, 2015

### 10

Table III

. 3

. Fluoxastrobin Label SummaryCrop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

Low growing berry subgroup (13

- 07G) Foliar;
broadcast (aerial and ground), chemigation 0.177 7 0.7107 NS NS [4] NS 1 14 New York c Reg. No. 66330

- 64

At planting; in
furrow

Tuberous and corm vegetables subgroup (1C) Foliar;
broadcast (aerial and ground), chemigation 0.1216 0.7107 NS NS [6] NS 7 7 New York c Reg. No. 66330

- 64

At planting; in
furrow

Leaf petioles subgroup (4B) Foliar;
broadcast (ground), chemigation 0.1777 0.7107 0.7107 NS [4] 4 7 New York c Reg. No. 66330

- 64

Melon subgroup (9A) Foliar;
broadcast (aerial and ground), chemigation 0.1777 0.7107 0.7107 NS [4] 4 1 7 New York c Reg. No. 66330

- 64

### 11Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

At planting; in
furrow

Squash/Cucumber subgroup (9B) Foliar;
broadcast (aerial and ground), chemigation 0.1777 0.7107 0.7107 NS [4] 4 1 7 New York c Reg. No. 66330

- 64

At planting; in
furrow

COMMERCIAL/INDUSTRIAL

LAWNS Foliar;
broadcast (ground), chemigation 0.7189 NS [1.6542] 1.6542 NS [3] NS [3] NA 14 Reg. No. 66330

- 379

CORN (ALL OR UNSPECIFIED) Foliar;
broadcast (aerial and ground), chemigation 0.1777 0.7107 0.7107 NS [4] 4 30 7 New York c Reg. No. 66330

- 64

At planting; in
furrow

### 12Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

CORN, FIELD Foliar;
broadcast (aerial and ground), chemigation 0.1777 0.3553 NS [0.3553] NS [2] 2 36 7 New York c Reg. No. 66330

- 64, 66330

- 383

At planting; in
furrow

Seed

Treatment 0.0006 lb/lb
seed 0.36 0.36 NS [3] d NS [3] d NS NS None 264

- 1169

CORN, SWEET Foliar;
broadcast

(aerial), chemigation 0.1184

0.4738 NS [0.4738] NS [4] 4 See footnote
h

14 New York c Reg. No. 66330

- 64 Foliar; banded (ground)
0.1777 At planting; in
furrow

Foliar;
broadcast (aerial and

ground ) 0.1172 0.4688 0.2344 NS [4] 2 None Reg. No. 66330

- 383

### 13Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

FRUITING VEGETABLES Foliar;
broadcast (ground), chemigation 0.1777 0.7107 NS [0.7107] NS [4] 4 3 7 New York c Reg. No. 66330

- 64

GOLF COURSE TURF Foliar;
broadcast (ground), chemigation 0.4644 NS [1.6542] 1.6542 NS [4] NA

NS 7 None Reg. No. 66330

- 379

Foliar;
broadcast (ground) 0.5079 2.1161 NS [2.1161] 4 NA 21 New York Reg. No.
66330

- 383

0.509 NS [2.2395] 2.2395 NS [1] NA 14 None Reg. No.
66330

- 379; do not make more than 2 applications at a rate greater than 14.6 pt/a per growing season

ORNAMENTAL LAWNS AND
TURF When needed;
broadcast (ground) 0.4987 2.132 NS [2.0] NS [5]

4 NS 7 New York c Reg. No. 66330

- 64

0.5067 2.1804 NS [2.0] NS [5] NS California e Reg. No. 66330

- 388

0.5 2.2 NS [2.0] NS [5] 4 7 California Granular Reg. No. 66330

- 380

### 14Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

When needed;
broadcast (ground) 1.19 NS [1.19] 4 NS [4] 14 None f Reg. No. 66330

- 407

ORNAMENTAL SOD FARM (TURF) Foliar;
broadcast (ground) 0.8271 NS [1.65] 0.8271 NS [2] NS [2 ]

NS 14 Residential
lawns Reg. No. 66330

- 379

When needed;
broadcast (ground) 0.5 2.2 NS [2.0] NS [5]
4 7 California Granular Reg. No. 66330

- 380

0.5067 2.1804 NS [2.0] NS [5] NS California e Reg. No. 66330

- 388

ORNAMENTALS (UNSPECIFIED) Foliar;
broadcast (ground), chemigation 0.1255 0.8087 NS [0.8087] 4

NA NS 14 New York c Reg. No. 66330

- 388

0.9968 2.132 NS [2.132] 4 7 New York c Reg. No. 66330

- 64 Label error reported g

0.1281 lb/ 100 gal 1.23 NS [1.23] NS [1 ] 7 New York c Reg. No. 66330

- 388

0.1247 2.132 NS [2.132] NS [17] NS [17] 7 Reg. No. 66330

- 64 Label error reported g

### 15Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

When needed;

soil drench,
soil treatment (ground) 2 2.132 NS [2.132] NS [2] NS [2] 14

Pre

- plant, Soil
mix 0.0001 lb/cu ft [0.55] 2.2 NS [2.2] NS [4] 4 28 Reg. No. 66330

- 380

PEANUTS (UNSPECIFIED) Foliar;
broadcast

(aerial) 0.1458 0.5834 NS [0.5834]

NS [4] 4 14 14 None Reg. Nos. 66330

- 383, 66330

- 64 Foliar; banded (ground)
0.1777 0.7107 NS [0.7107] At planting; in
furrow

POTATO, WHITE/IRISH (OR UNSPECIFIED) Foliar; banded (ground)
0.1216 0.7107 NS [0.7107] NS [6] 6 7 7 Only
allowed in

Idaho Reg. No. ID080006 At planting; in
furrow

RESIDENTIAL LAWNS When needed;
broadcast (ground) 0.4 1.19 NA 4 NA NS 14 None Reg. No. 66330

- 407

### 16Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

RICE Foliar;
broadcast (aerial and ground), chemigation 0.1777 0.3553 NS [0.3553] NS [2] 2 28 27 New York c
California Reg. No. 66330

- 64

SORGHUM (UNSPECIFIED) Foliar;
broadcast (aerial and ground), chemigation 0.1247

0.2494 NS [0.2494] NS [2] 2 14 14 New York c
California Reg. No. 66330

- 64 At planting; in
furrow

Foliar; banded (ground)

0.1309

### 17Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

SOYBEANS (UNSPECIFIED) Foliar;
broadcast (aerial and ground), chemigation
0.1777 0.3553 NS [0.3553] NS [2] 2 30 14 New York c
California Reg. Nos. 66330

- 383, 66330

- 64,
66330

- 409

Foliar; banded (ground)

At planting; in
furrow Reg. No. 66330

- 64

WHEAT Foliar;
broadcast (aerial and ground), chemigation 0.1247 0.2494 NS [0.2494] NS [2] 2 See footnote
i 14 New York c
California Reg. No. 66330

- 64; lower applications permitted with shorter MRIs (0.0781 lb a.i./A has 7 days MRI)

a. Reported as per crop cycle or per season
b. PHI

– Preharvest Interval; MRI

– Minimum Retreatment Interval

c. In New York State, this product may not be applied within 100 feet of a coastal marsh or stream that drains directly into a c oastal marsh; Sale, use, an d distribution of this product in Nassau and Suffolk Counties of New York State is prohibited.
d. Assumes seed treatment and foliar applications can occur for a single crop.

e. Not for use in California to control Rhizoctonia Sheath Spot (Rhizoctonia zea I Waitea circinata varzeae); Not for homeowner use. May only be applied to residential turf by a certified pest control operator
f. Non

- residential turf "

g. Label error: The soil rates are less than the max yearly rate and the broadcast/chemigation exceeds the ma x yearly rate. Intended use needs to be clarified.

### 18Crop/Site Timing; Application Type; Method/ Equipment Maximum Single Application

Rate by
Formulation Maximum Application Rate Maximum Application

NumberPHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year lb/A Per CC a lb/A Per
Year Per
CC a

h. 49 day(s) preharvest interval (fodder).,7 day(s) preharvest interval (forage) at higher application rates; 7 day(s) preharves t interval (forage, fodder).,23 (days) preharvest interval (stover) at lower app lication rates
i. 40 day(s) preharvest interval (fodder).,7 day(s) preharvest interval (forage).,40 day(s) preharvest interval (grain).,7 day(s ) preharvest interval (dry hay).

### 19

A. Environmental Fate and Transport

Based on physicochemical properties ( Table III

. 1 ) alone, volatility is not expected to be a major dissipation pathway for fluoxastrobin , and fluoxastr obin is not expected to bio concentrate

. In summary, b ased on laboratory studies, fluoxastrobin persists in soils for several months to more than a year, and is slightly to moderately mobile in soils. As for aquatic environments, fluoxastrobin has been show n to be stable to hydrolysis. Fluoxastrobin is slightly susceptible to microbial degradation in aquatic
environments. E nvironmental fate parameters of fluoxastrobin are presented in Table III

. 5 and
summarized below

.

Fluoxastrobin is stable in sterile solutions at pH 4, 7, and 9 at 50 °C (MRID 45865304). Aqueous photolysis of fluoxastrobin has been shown to be a major route of fluo xastrobin (chlorophenyl labeled ring 98:2 E:Z isomer ratio) transformation in sterile water (MRIDs 45865306, 45865403). The
concentration of the z

- isomer increased upon radiation reaching an E:Z isomer ratio of approximately 7:1 during the study. One majo r transformation product (HEC 5725

- oxazepine; 23.6% of maximum concentration of applied) and one minor (HEC 5725

- phenoxy

- amino

- pyrimidine; 4.7% maximum concentration of applied) was observed. A n additional photolysis study performed in natural water/sedim ent systems (MRID 45865327 ) indicates that the majority of applied fluoxastrobin adsorbs to sediment and no transformation occurs under pseudo environmental conditions. Thus, the dissipation of fluoxastrobin in water is expected to depend on physical characteristics of the water (e. g., sediment loading, depth, etc.) which have an effect on sunlight penetration as well as the rate of fluoxastrobin sediment partitioning.

A erobic soil metabolism half

- life values for extracted residues 15.3 to 5 40 days in four soils (MRID 45865309, 4586 5310 ) . Both of these studies have been reclassified to supplement al as there is approximately 20 to 70% unextracted residues depending on the test soil. Examination of the suite of
studies indicates that a s the amount of unextracted residues increase the h alf

- life value decreases. Given the wide range in calculated half

- life values and the large amount of unextracted residues
fluoxastrobin is thought to be persistent. Major transformation products observ ed in these studies
include HEC 7155 and carbon dioxid e. Minor transformation products include HEC 5725

- 4

- hydroxyphenyl and HEC 7338

.

Aerobic aquatic metabolism total system (sediment and water) half

- life values for fluoxastrobin are 227
and 3 90 days (MRID 45865313 )

. HEC 7155 is the only major transformation product observed with a maximum observed concentration of approximately 20% ; however, several minor transformation prod ucts were observed including HEC 7334

, HEC 7180 and HEC 7338. I n anaerobic environments,
fluoxastrobin degr aded with total system half

- l ife value of 310 days ( MRID 45865312 )

. I n anaerobic aquatic environments

, the major transformation product observed was HEC 7180 with a maximum observed concentration of approximately 20%. The only minor transformation product identified was
HEC 7338. Fluoxastrobin was observed to partition to sediment under aerobic and anaerobic aquatic
conditions.

Based upon batch equilibrium data (K oc 

### 424

– 1580; MRID 45865315) fluoxastrobin is considered mobile to moderately mobile based on FAO mobility classifica tion 9 

### . None of the test soils had an organic matter
content ≤1%. Fluoxastrobin transformation product s , HEC 7155 and HEC 7334, are both more mobile

9 USEPA, 2006. Standardized Soil Mobility Classification Guidance. Memorandum: S. Bradbury, April 21, 2006.

### 20

than fluoxastrobin (K oc 

### 14

– 181.5; MRID 45865314 , K oc 

### 37

– 87; MRID 45865316, respectively ). Adsorption and desorption constants are provided in Table III

. 4

. High performance liquid chromatography was used to estimate adsorption coefficients (K oc 

### ) for HEC5725

- amide, HEC5725

- hydroxyphenyl, and HEC5725

- carboxylic acid (MRID 45865401) . The values (estimated 505, 319, and 39, respectively) suggest these transformation products are generally more mobile than fluoxastrobin.

Table III

. 4

. Adsorption and Desorption Constants

Soil Adsorption Desorption

K 1/N R 2 K oc K 1/N R 2 K oc
Fluoxastrobin ; MRID 45865315, acceptable

Laacher Hof AXXa sandy loam 12.70 0.8356 0.9886 628.8 20.33 0.8781 0.9995 1006.3

Höfchen am Hohenseh 4a silt 16.21 0.8738 0.9946 757.6 23.30 0.8922 0.9999 1088.7

Stanley silty clay loam 26.26 0.8749 0.9969 1582.1 23.91 0.8645 1.0000 1440.4

Byromville loamy sand 3.35 0.8493 0.9994 424.3 5.09 0.8666 0.9982 644.6

HEC 5725

- E

- des

- chlorophenyl (HEC 7155) ; MRID 45865314, acceptable

Laacher Hof AXXa sandy loam 0.28 0.94 1.0000 14.0 1.36 0.97 0.9995 67.3

Höfchen am Hohenseh 4a silt 0.47 0.95 0.9999 22.1 1.29 0.98 0.9997 60.3

Stanley silty clay loam 3.01 0.98 0.9999 181.5 3.01 0.97 0.9999 181.5

Byromville loamy sand 0.18 0.92 0.9999 23.4 1.29 0.99 0.9994 163.0

HEC 5725

- des

- chlorophenyl carboxylic acid (HEC 7334) ; MRID 45865316, acceptable

BBA 2.2 loamy sand 1.12 0.9590 0.9999 56 3.46 0.9560 0.9985 174

Laacher Hof AXXa sandy loam 0.58 0.8610 0.9989 56 2.49 0.8449 0.9987 244

Boden LUFA Speyer sandy loam 0.50 0.8993 0.9998 37 2.69 0.9366 0.9971 196

Stanley silty clay 1.41 0.8979 0.9994 87 5.21 0.9467 0.9993 322

K

- Freundlich adsorption and desorption coefficients (L/Kg

- soil) ; 1/N

- Slope of Freundlich adsorption/desorption isotherms; K oc - Coefficient adsorption per organic carbon (L/kg OC) ; R 2

- Regression coefficient of Freundlich equation.



### Terrestrial field dissipation studies indicate that fluoxastrobin persists for over a year. However, it was not observed to leach through soil. Out of the three major metabolites mentioned above, only HEC 7155 was detected in the terrestrial field studies. The observed concentration of HEC 7155 is below 10% of the total applied. This metabolite is also observed in the deeper soil layers, but at less than 1% of the total applied. A recently submitted aqu atic field dissipation study conducted on rice has several deficiencies; however, the study suggests fluoxastrobin readily dissipates from the water column but may persist in sediment. The rapid dissipation of fluoxastrobin from the water column is due to partitioning to sediment; however, the role of transformation was not investigated. The route of fluoxastrobin dissipation under aquatic field conditions could not be determined as soil and water samples were not analyzed for transformation products. The t otal system (water and soil/sediment)
half

- life as well as residual residues indicate fluoxastrobin persists beyond the study duration. This suggests that accumulation (carry over) of fluoxastrobin in rice paddies is possible. The mobility of

### 21

fluoxastrobin in the soil profile could not be assessed based on the data included in this study. These results are consistent with laboratory studies.

The storage stability study (MRID 46569701) indicates fluoxastrobin and relevant transformation products are stable up to 37

- 38 months in soils. No acceptable storage stability data are available for
fluoxastrobin in aquatic systems

. I t should be noted that an aquatic field dissipation study was submitted as part of the request to register fluoxastrobin for use on rice. This study was classified as upgradable because storage stability data were not provided with the submission.

The environmental chemistry method for soil reports the limit of quantification (LOQ) of fluoxastrobin (E/Z isomers), HEC 5725

- E

- des

- chloropheny l and HEC 5725

- E/Z

- carboxylic acid as 5 μg/kg (0.01 lb/A ) 10 

### with a limit of detection of 2 μg/kg (M RID 45865328 )]. An environmental chemistry method for water reports a LOQ for HEC 5725 0.05 μg/L (0.000005 lb a.i./A; MRID 45865331). An independent laborator y valida tion is not available for the water method. Based on toxicity information presented in Table IV

. 1 and Table IV

. 2 these methods are adequate for detecting fluoxastrobin at concentration s that are below
the level of concern for all taxa that data are available.

M aximum bioco ncentration factor (BCF) for fluoxastrobin residues was 19.5

- 26.2 for the edible tissues,

1 19.1

- 131.1 for the nonedible tissues, and 6 1.6

- 66.9 for the whole fish (MR ID 458654

- 21) . The steady
state bioconcentration factor (BCF) ranged from 13.3

- 18.2 for both isomers in whole fish tissue. Depuration occurred rapidly with approximately 80 % of the residues eliminated one day after exposure
ceased. Approximately 95% of the residues were eliminated after 14 days of no exposure. The E

- isomer was favored with an approximate ratio of 13:1 at 7 days and 10:1 at 14 days. Three transformation products were identified: HEC5725

- E

- des

- chlorophenyl and HEC5725

- di

- OH

- diene

.

10 LOQ = 0.0 05 m g/kg (LOD = 0.0 02 m g/kg )

0.0 05 mg/kg (s) = [x] kg/ha x 10 6 mg/kg / [0.15 m (depth) x 10 4 m 2 /ha x 1.5 x 10 3 kg(s)/m 3 (density)]

0.0 05 mg/kg(s) = [x] kg/ha x 10 6 mg/kg / 2.25 x 10 6 kg (s)/ha

= 1.1 x 10

- 2 kg/ha = LOQ = 0.0 1 lb a.i. /A

### 22

Table III

. 5

. Environmental Fate Parameters of Fluoxastrobin

Study/
Guideline System Name/
Characteristics Kinetic Model Fitted a Value
and Unit (Fitting Equation) Representative Half

- life
Value

-- Value Used to Derive

Model Input Values (days) b

-- Source/
Classification Comments

DT50 (days) DT90 (days)

Hydrolysis
835.2010 pH 4, 50  ̊C

stable 0 MRID
45865304 acceptable pH 7, 50  ̊C pH 9, 50  ̊C

Aqueous Photolysis
835.2240 0.02 M phosphate, pH 7 adjusted: 8.2 (4.1) MRIDs 45865306,
45865403 acceptable Adjusted value reflects 12

- h light/12

- h dark cycle; 1 hours of irradiation were reported to be equivalent to 4.9 days in June in Phoenix, Arizona (33.26  ̊N); 1 hour or irradiation were reported to be equivalent to 6.9 days in june in Edmonton, Alberta, Canada (53.33  ̊N). Representative half

- life value reflects adjustment to 40  ̊N. Pond (Hönniger Weiher) pH

5.8 (sediment, CaCl 2 ), 6.7

(H 2 0), 4.80% OC, 25  ̊C MRID
458365327 supplemental Previously reported values 51 days

Lake (Angler Weiher) pH 7.4 (sediment, CaCl 2 ),pH 7.2 (H 2 O) 1.37% OC, 25  ̊C Previously reported value 39 days

Soil Photolysis
835.2410 Loamy sand, pH 6. 1; 0.79% OC, 20  ̊C stable 0 MRID
45865308 acceptable

Aerobic Soil
Metabolism

835.4100 Sandy loam ( Monheim, Germany ; Laacher Hof

AXXa ), pH 6.4

- 7.0, 1.8% O C,
3.1% OM 18.5 (IORE) 74.8 (IORE) T R = 22.5 (IORE) MRID
45865309

Reclassified as supplemental Methoxyiminotolyl

- ring labeled study; Previously reported half

- life value was 29.4 days. The presented half

- life value only represents extracted residues. The soil extraction methods utilized in this study are not
considered exhaustive and a n increasing

am ount of non

- extracted residues were observed (70.6% at 120 DAT).

Silt (Burscheid, Germany;
Hoefchen Am Hohenseh 11.2 (IORE) 50.7 (IORE) T R = 15.3 (IORE) MRID
45865310 Previously reported half

- life value was 26.2 and
30.1 days. The presented half

- life value represents extracted residues of both

### 23

Study/
Guideline System Name/
Characteristics Kinetic Model Fitted a Value
and Unit (Fitting Equation) Representative Half

- life
Value

-- Value Used to Derive

Model Input Values (days) b

-- Source/
Classification Comments

DT50 (days) DT90 (days) 4A) pH 7.8 (H 2 O), 2.6% OC,
4.5% OM Reclassified as supplemental radiolabeled compounds. The soil extraction methods utilized in this study are not considered exhaustive and an increasing

amoun t of non

- extracted residues were observed ( Pyrimidine

- labeled study: 35.2% at
120 DAT and Methoxyiminotolyl

- ring: 57.8% at
120 DAT). Neither radiolabeled experiment had replicates.

Silt loam (Monheim, Germany; Laacherhof A II)

pH 8.1 (H 2 O), 0.86% OC,
1.48% OM 47.1 (SFO) 156 (SFO) t 1⁄2 = 47.1 (SFO) Methoxyiminotolyl

- ring labeled study; Previously reported half

- life value was 46.6 days. The presented half

- life value only represents extracted residues. The soil extraction methods utilized in this study are not considered exhaustive and an increasing
amount of non

- extracted residues were observed (38.7% at 120 DAT).

Loamy sand (Georgia, USA); Byromville) pH 6.1,

- % OC,
0.43% OM 331 (DFOP) 1585 (DFOP) t 1⁄2 slow = 540 (DFOP) Previously reported half

- life value were 323 and 393 days for fluoxastrobin labeled in two different locations. The presented half

- life value represents extracted residues of both radiolabeled compounds. The soil extraction methods utilized in this study a re not considered exhaustive and an increasing
amount of non

- extracted residues were observed (Pyrimidine

- labeled study: 22.6% at DAT 270 and Methoxyiminotolyl

- ring labeled study: 23.4% at 365 DAT). Neither radiolabeled experiment had replicates.

Anaerobic Soil

Metabolism

835.4200 No data

### 24

Study/
Guideline System Name/
Characteristics Kinetic Model Fitted a Value
and Unit (Fitting Equation) Representative Half

- life
Value

-- Value Used to Derive

Model Input Values (days) b

-- Source/
Classification Comments

DT50 (days) DT90 (days)

Aerobic Aquatic
Metabolism

835.4300 Loam (Wipperfürth, Germany; Hӧnnlger) pH 6.6 (H 2 O), 4.8% OC, 8.28% OM 263 1168 t 1⁄2 slow = 390 (DFOP) MRIDs 45865313,
46925806 acceptable Previously reported half

- life values were 150 and 190 days for fluoxastrobin in the two different test systems. The registrant responded (MRID 46925806) to the deficiencies in the data evaluation report and the acceptability of the aerobic aquatic study submitted in support of the fluoxastrob in registration (MRID 45865313). The study was reevaluated and determined to be acceptable as EFED does not expect fluoxastrobin to sorb to the glass test apparatus to a sufficient degree to affect the study results, as demonstrated by the material balance

. Unextracted residues were observed at concentrations up to 12% at 122 DAT. Loamy sand (Leverkusen, Germany; Anglerweiher) pH 8.5, 1.37% OC, 2.36% OM 164 (DFOP) 691 (DFOP) t 1⁄2 slow = 227 (DFOP)

Anaerobic

Aquatic
Metabolism

834.4400 Sandy loam/loamy sand (Georgia, USA; Fuquay) pH 5.3, 0.46% OC, 0.79% OM 122 (DFOP) 810 (DFOP) t 1⁄2 slow = 310 (DFOP) MRIDs 45865312,
46925806 acceptable Previously reported half

- life value was 187 days for fluoxastrobin. The registrant responded (MRID 46925806) to the deficiencies in the data evaluation report and the acceptability of the anaerobic aquatic studies submitted in support of the fluoxastrobin registration (MRID 45865312). The study was reevaluated and determined to be acceptable as EFED doe s not expect fluoxastrobin to sorb to the glass test apparatus to a sufficient degree to affect the study results, as demonstrated by the material
balance. Unextracted residues were observed at concentrations up to 36.2% at 360 DAT.
Terrestrial
Field Dissipation
835.6100 Burscheid, Germany/Silt
loam soil 78.8, (SFO) Not
calculated - MRIDs 45865317,
45865402 Transformation was observed to be biphasic; however, the kinetic analyses were not updated as the results are not used for modeling. Monheim, Germany/Sandy
loam soil 92.4 (SFO)

### 25

Study/
Guideline System Name/
Characteristics Kinetic Model Fitted a Value
and Unit (Fitting Equation) Representative Half

- life
Value

-- Value Used to Derive

Model Input Values (days) b

-- Source/
Classification Comments

DT50 (days) DT90 (days) Thurston, Great Britain/Sandy clay loam soil 169.1 (SFO) Feuquerolles, France/Silt
loam soil 123.8 (SFO) Watsonville, California/sandy loam 578 (SFO) Not
calculated - MRID
45865318 The kinetic analysis were not updated as the results are not used for modeling North Rose, New York/Loamy sand 533 (SFO) Not
calculated - MRID
45865320 The kinetic analysis were not updated as the results are not used for modeling North Rose, New York/Loamy sand (turf) 347 (SFO) Not calculated - MRID
45865324 The kinetic analysis were not updated as the results are not used for modeling

239 Not
calculated - MRID
45865323 Supplemental T urf ; Frozen storage stability study was inadequate. Test samples were stored frozen for up to 1,032 days ( ca . 34 months) prior to extraction, while storage stability data were only provided for up to a period of 15 months.

L e aching was observed for fluoxastrobin and to
a greater exten t for the E

- des

- chlorophenyl.

Aquatic Field

Dis sipation
835.6200 Silt loam (rice paddy, Arkansas) pH 5.3, 0.8% OC (0

- 5 cm) 135 (total
system following

second application;
DFOP slow

half

- life) Not calculated - MRID
48532004 Upgradeable The storage stability data reported were
insufficient to determine the stability of fluoxastrobin. Soil and water samples were not analyzed for transformation products . An independent laboratory method validation was not provided.

DT50 and DT90 values were calculated using single first

- order (SFO), double first

- order in parallel (DFOP), or indeter minate

- order equation (IORE). For DFOP, the overall DT50 and DT90 are reported when available. The equations can be found in the document, Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half

- life Values and Characterize Pesticide Degradation, U.S. Environmental Protection Agency, March 23, 2012. The value used to estimate a model input value is the calculated SFO DT 50 , T IORE , or the 2 nd DT 50 from the DFOP equation. The mod el chosen is consistent with that recommended using the, Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media , Health Canada, U.S. Environmental Protection Agency, December 21, 2012. The same model used to estimate the value used to derive a model input, is used to describe the DT50 and DT90 results.

### 26

IV. RECEPTORS

Table IV

. 1 and Table IV

. 2 provide a summary of the terrestrial and aquatic toxicity data, respectively, and the most sensitive surrogate species tested to characteri ze the potential acute and chronic ecological effects of fluoxastrobin

. Table IV

. 3 provides information on the non

- guideline toxicit y data
available f or fluoxastrobin

.

Table IV

. 1

. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for
Fluoxastrobin

Study Type Endpoint Value Used in Risk

Assessment Toxicity
Classification Study Rating MRID Comments

Acute
Mammalian
O ral
870.1100 (r at ) LD 50 > 2,000 mg a.i./kg

bw Practically
nontoxic Acceptable 45865612

-

Mammalian Reproduction

870.3800 (rat) NOAEC/

LOAEC 70 mg a.i./kg

- bw

- Acceptable 45865634

Avian Acute Oral
850.2100 (Bobwhite) LD 50 > 2,000 mg a.i./kg

bw Practically
Nontoxic Acceptable 45865422

-

Avian Dietary Toxicity
850.2200 (Bobwhite) LC 50 > 4845 mg a.i./kg

diet - Acceptable 45865423

-

Avian Reproductive

(chronic)

850.2300 (Mallard Duck) NOAEC/

LOAEC 461 mg a.i./kg

- diet /

1394 mg a.i./kg

- diet - Acceptable 45865426 Based on
reductions
in female body weight

and egg production.

Honey Bee Adult

Acute Oral And Contact Toxicity (850.3020) LD 50 > 200 μg a.i./bee (contact) Practically
Nontoxic Acceptable 45865427

-

Terrestrial Plant Toxicity, Seedling Emergence
850.4100 EC 25 > 0.54 lb a.i./acre

-

Acceptable 45865428 -

NOAEC 0.54 lb a.i./acre

- No reductions
exceeded
25%

### 27

Study Type Endpoint Value Used in Risk

Assessment Toxicity
Classification Study Rating MRID Comments

Terrestrial Plant Toxicity, Vegetative Vigor
850.4150 EC 25 > 0.54 lb a.i./acre

-

Acceptable 45865428 -

NOAEC 0.54 lb a.i./acre

- No
reductions
exceeded
25%



### Table IV

. 2

. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Fluoxastrobin

Study

Guideline

(taxa) Endpoint Toxicity Value Toxicity
Classification Study Rating MRID Comments

F ish Acute Toxicity

, F reshwater
850.1075 ( Rainbow Trout ) LC 50 0.435 mg a.i./L Highly Toxic Acceptable 45865414

-

F ish Early

- Life Stage

,

Freshwater
850.1400 ( Rainbow Trout ) NOAEC/

LOAEC 0.0557 mg a.i./L

> 0.0557 mg a.i./L - Supplemental 45865420 No effects at

any concertation

tested (no

LOAEC was established)

Aquatic
Invertebrate Acute Toxicity

,

F reshwater
850.1010 ( Gammarus pulex ) EC 50 0.12 mg a.i./ L Highly Toxic Supplemental 46080402 Study was
conducted
with non

guideline species

Life

- Cycle
Freshwater
Invertebrate NOAEC 0.045 mg a.i./L

- Value based on acute

- to

- chronic ratio using acute/chronic data on daphnids 0.48 mg a.i./L (MRID 45865406) / 0.18 mg a.i./L (MRID 45865418) x 0.12 mg a.i./L (MRID 46080402)

F ish Acute Toxicity

, E stuarine/
Saltwater
850.1075 (Sheepshead

Minnow) 96

- hr

LC 50 >1.374 mg a.i./L Moderately
Toxic Supplemental 45865417 Reported practical solubility in
salt water is
1600 μ g/L.

### 28

Study

Guideline

(taxa) Endpoint Toxicity Value Toxicity
Classification Study Rating MRID Comments

I nvertebrate

Acute T oxicity

Estuarine/

S altwater
850.1025 (eastern oyster) 96

- hr

E C 50 0.83 mg a.i./L Highly Toxic Supplemental 45865410 N ew shell growth did not

meet
minimum requirement

.

I nvertebrate

Acute T oxicity

Estuarine/

S altwater
850.1035 (mysid shrimp) 96

- hr

L C 50 0.0516 mg a.i./L Highly Toxic Acceptable 45865411 The solubility
limit under the
test conditions

(salt water)

was not provided ; however, solubility is expected to be

much higher

than test
concentrations

. Chronic Life

- Cycle Estuarine/ Marine
Invertebrate

850.1350

(m ysid) NOAEC /

LOEC 0.00061 mg a.i./L /

0.00119 mg a.i./L

- Supplemental 45865419 Based on
reduced
survival and

growth

Whole Sediment:
Acute Freshwater

Invertebrates

850.1735 (midge) 10

- day Sediment:

EC 50 = 103 mg a.i./kg

NOAEC = 12 mg a.i./kg LOEC = 31 mg a.i./kg - In Review 49317701 This study is
under review.
The endpoints provided are study author

reported
values based
on survival.

Whole Sediment:

Acute Marine
Invertebrates

850.1740 10

- day Sediment:

L C 50 = 0.51 mg a.i./kg

NOAEC = 0.19 mg a.i./kg LOEC = 0.38 mg a.i./kg - In Review 49317702 This study is
under review. The endpoints provided are study author

reported
values based
on survival.

Aquatic Plant, Tier

I

– Vascular
850.4400 (Duckweed) EC 50 1.2 mg a.i./L

-

Acceptable 45865430 -

NOAEC 0.16 mg a.i./L

- Based on
reduced frond
number.

EC 50 0.26 mg a.i./L

- Acceptable 45865431

-

### 29

Study

Guideline

(taxa) Endpoint Toxicity Value Toxicity
Classification Study Rating MRID Comments

Aquatic Plant, Tier

I

– Non

- Vascular
850.5400 (green algae ) NOAEC 0.076 mg a.i./L

- Based on
reduced cell

density

For aquatic plants, the EC 50 is used to calculate the non

- listed plant RQ and the NOAEC is used to calculate the listed plant RQ.

### 30

Table IV

. 3

. Summary of the N on
- Guideline Toxicity Endpoints for Fluoxastrobin

Study Endpoint Toxicity Value Toxicity
Classification Study Rating MRID Comment

Chronic Indoor

Microcosm, amphipod LC 50 0.086 mg a.i./L Supplemental 46404901 Day 7

NOEC 0.015 mg a.i./L Day 28

Earthworm

toxicity,
Subchronic LR 50 > 1000 mg a.i./kg Supplemental 45865502



### A. Ecological Incidents

Three incident databases are available: 1) the Ecological Incident Information System v. 2.1.1 (EIIS), maintained by EFED; 2) the Avian Incident Monitoring System (AIMS), maintained by the American Bird Conservancy; and, 3) the Incident Data System (IDS) m aintained by OPP. These databases were searched
and the results are summarized below

.

The Ecological Incident Information System (EIIS) database was queried on November 5, 2015 for
incidents related to fluoxastrobin use and no incidents were identified.

The Avian Incident Monitoring System (AIMS), a database administered by the American Bird Conservancy, was not working properly and was not queried ; however, the AIMS database has not been updated since the last fluoxastrobin assessment was conducted and no inc idents to birds were reported
at that time.

A query of the aggregate Incident System (IDS) on November 9, 2015 reported no incidents.

The absence of documented incidents in these databases does not necessarily mean that such incidents
did not occu r. Mortality incidents must be seen, reported, investigated, and submitted to the Agency in order to be recorded in the incident databases. In addition, incident reports for non

- target organisms typically provide information only on mortality events and plant damage. Sublethal effects in organisms such as abnormal behavior, reduced growth and/or impaired reproduction are rarely reported, except for phytotoxic effects in terrestrial plants.

B. Exposure Pathways of Concern

Based on the use pattern and environm ental fate characteristics of this pesticide, the following exposure pathways are expected to be most relevant for determining exposure and potential risk to non

- target organisms:

• Direct spray

• Spray drift

• Runoff

• Leaching to ground water followed by irriga tion

In addition, terrestrial animals that use treated fields may be exposed to fluoxastrobin from consuming contaminated plants and invertebrates, dermal absorption, and drinking from contaminated puddles. Drinking water exposure pathways were screened u sing SIP (Screening Imbibition Program) and indicate

### 31

that drinking from contaminated puddles is not a pathway of potential concern for fluoxastrobin

. The potential for i nhalation exposure was screened using S TIR (Screening Tool for Inhalation Risk )

. Based on this analysis inhalation is a pathway of low concern

.

SIP and STIR are described in detail at http://www.epa.gov/oppefed1/models/terrestrial/index.htm and the SIP and STIR model inputs and outputs for fluoxastrobin are available in APPENDICES B AND C

, respectively.

While fluoxastrobin is expected to be taken up by plants and translocated

, concentrations in nectar and pollen are unknown. Nevertheless, both oral and contact exposure to pollinators is expected to occur as a result of direct sp r ay o nto crop during blooming periods

.

V. ANALYSIS PLAN

A. Ecological Risk Assessment



### 1. Stressors of Concern

Fluoxastrobin is the only residue considered as a stressor of concern. Based on available data for a variety of taxa, fluoxastrobin is expected to be considerably more toxic than its environmental degradation products to non

- target species.

Data on the degradate HEC 7155 ha ve been submitted for aquatic invertebrate D aphnia magna (MRID 45865409), the fresh water fish rainbow trout (MRID 45865 4 16), the aquatic non

- vascular plant green alga (MRID 45865501)

. Data on the transformation products HEC 7180 ha ve been submitted for the aquatic invertebrate D aphnia magna (MRID 45865408), the aquatic non

- vascular plant green alga (MRID
45865432 ) , and the fresh water fish rainbow trout (MRID 45865 4 15). For both compounds , the sensitivity of the test species to the transformation products appears to be orders of magnitude less than the sensitivity to the parent fluoxastrobin

. The H ealth E ffects D ivision has not in dicated that
fluoxastrobin environmental transformation products are residues of concern

. No additional data, are available to know the toxicity of the transformation products to other taxa ; however, based on the available data, the transformation products appear to be less toxic than the parent.



### 2. Measures of Exposure

In order to estimate risks of fluoxastrobin exposure to aquatic and terrestrial organisms, all exposure modeling and resulting risk conclusions will be made based on maximum application rates , application methods, and any mitigation measures specifically indicated on the label. The models that will be used to predict the EECs are discussed on OPP’s model website. 11



### Available monitoring data will be evaluated and considered in an assessment conducted for Registration
Review.

Exposure to terrestrial animals is estimated using the Terrestrial Residue Exposure (T

- REX) model. Exposure to terrestrial plants is estimated using the TerrPlant model. For terrestrial plants, exposure is
based on the c alculated maximum application rates with assumed exposure from runoff, but not spray

11 http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/models

- pesticide

- risk

- assessment

### 32

drift. A description of t hese models may be found at: http://www2.epa.gov/pesticide

- science

- and

assessing

- pesticide

- risks/models

- pesticide

- risk

- assessment

.



### 3. Measure of Effects

Ecological effects data are used as measures of direct and indirect effects to biological receptors. Data are typically obtained from registrant

- submitted studies and from literature studies identified by
ECOTOX (USEPA 2014) . 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 the U.S. EPA, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory 's Mid

- Continent Ecology Division. Toxicity data presented in
Section IV of this problem formulation will be used in the quantitative risk assessment. Any additional toxicity data submitted by the registrant , as well as relevant toxicity information found in the open
literature

, will also be considered.



### 4. Integration of Exposure and Effects

Exposure and effects will be integrated in an updated risk assessment for fluoxastrobin (described in the stressors of concern section of this document) , incorporating new data (described in the identification of data gaps section of this document) and analytical approaches (current as of the time of the updated assessment) , label clarifications, and any additional information obtained since the previous risk

assessments we re conducted.



### 5. Endangered Species Assessments

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in

a ccordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obliga tions under the ESA and FIFRA. EPA will address concerns specific to
fluoxastrobin in connection with the development of its final registration review decision for
fluoxastrobin

.

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the Services), and
USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interi m Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper

, Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the

Nat ional Academy of Sciences April 2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this ecological problem formulation supporting the Preliminary Work Plan for f luoxastrobin does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during regi stration review. While the agencies continue to

### 33

develop a common method for ESA analysis, the planned risk assessment for the registration review of
fluoxastrobin will describe the level of ESA analysis completed for this particular registration review

ca se. This assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed an d implemented the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of fluoxastrobin as part of completing this registration review.



### 6. Endocrine Disruptor Screening Program

Fluoxastrobin was not included in the first group of 67 chemicals issued an order to conduct Tier 1 EDSP testing. Tier 1 screening results for List 1 chemicals are available at http://www2.epa.gov/ingredients

used

- pesticide

- products/endocrine

- disruptor

- screening

- program

- tier

- 1

- assessments

. For additional information on the EDSP, visit http://www.epa.gov/endo/

.

B. Drinking Water

Unless additional data are provided on unextracted residues observed in the environmental fate studies

an updated drinking water assessment fo r registration review will be completed in order to capture the uncertainty associated with these unextracted residues. Unextracted residues were not addressed in previous drinking water assessments. The most recent drinking water assessment conducted fo r seed treatment of corn (based on applications to turf) will be used as the basis for the updated assessment following the unextracted residues guidance

. 12



### VI. PRELIMINARY IDENTIFI CATION OF DATA GAPS

A. Environmental Fate

Table VI

. 1 identif ies environmental fate studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in orde r to support risk

assessment.

B. Ecological Effects

Table VI

. 2 and identify ecological effects studies for aquatic and terrestrial organisms, respectively, that provide data for each guideline requirement. These tables also identify the study classifications and indicate whether EFED recommends requesting additional d ata in order to support risk assessment and the rationale for the data request.

12 Brady, D. Guidance for Addressing Unextracted Residues in Laboratory Studies, September 12, 2014

### 34

Table VI

. 1

. Environmental Fate Data for Fluoxastrobin and Its Environmental Transformation Products

OCSPP Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

835.2120 Hydrolysis Hellpointner, E. (1999) Hydrolysis of (Methoxyiminotolyl

- Ring

- UL

- (Carbon 14)) HEC 5725 in Sterile Aqueous Buffer Solutions: Lab Project Number: M
1110904

- 6: MR

- 058

- 99: PF

- E/MR. Unpublished study prepared by Bayer AG. 44 p. 45865304 Acceptable

No --

Brumhard, B. (2001) Aqueous Hydrolysis of HEC5725 Under Conditions of Processing Studies: Lab Project
Number: M1771 136

- 6: MR

- 426

- 01: PF

- E/MR. Unpublished study prepared by Bayer AG. 34 p. 45865305 Unacceptable

835.2240 Aqueous Photolysis Stupp, H. (2001) Photolysis of HEC 5725 in Aqueous Solution: Lab Project Number: MR 072

- 00: M 1120905

- 8. Unpublished study prepared by Bayer AG. 81 p. 45865306 Acceptable

No

-- Hellpointner, E. (2001) Determination of the Quantum
Yield and Assessment of the Environmental Half

- Life of the Direct Photogradation in Water of HEC5725: Lab Project Number: M1430940

- 1: MR 540/00. Unpublished study prepared by Bayer AG. 39 p. 45865307

Schafer, H. (2001) Calculation of a DT

- 50 Value of HEC5725 Metabolite Oxazepine Generated by Photolysis in Aqueous Solution: Lab Project Number: MR

- 262/0 1:

MR262

- 01: P 668 01 6521. Unpublished study prepared by Bayer Ag. 16 p. 45865403 Acceptable

Stupp, H. (20) Photolysis of HEC5725 in Water/Sediment Systems: Lab Project Number: MR 322/01: M 112 1135

- 4: PF

- E/MR. Unpublished study prepared by Bayer AG. 54 p. 45865327 Supplemental

835.2410 Soil Photolysis Hellpointner, E. (2001) Photolysis of HEC5725 on Soil Surface: Lab Project Number: M1 130939

- 6: MR 347/00. Unpublished study prepared by Bayer AG. 92 p. 45865308 Acceptable No --

### 35

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

835.4100 Aerobic Soil
Metabolism Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation of (Methoxyiminotolyl

- Ring

- UL

- (Carbon 14)) HEC5725 in Soil Laacher Hof AXXa: Lab Project Number: M 125 0886

- O: MR 230/01: THS 4727. Unpublished study prepared by Bayer AG. 58 p. 45865309 Supplemental

No The soil ex traction methods utilized in

t he s e study are not considered exhaustive and an increasing amount of non

extracted residues were observed . In absence of additional, the non

- extracted
residues will be considered in the calculation of the model input values used
for risk assessment. Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation and Metabolism of (Methoxyiminotolyl

- Ring

- UL

- (Carbon 14)

- and (Pyrimidine

- 2

- (Carbon 14) HEC5725 in Thre Soils: Lab Project Number: M 125 0894

- 9: MR

- 231/01:

MR

- 23 1

- O 1. Unpublished study prepared by Bay er Ag. 124 p. 45865310 Supplemental

Stupp, H. (2002) HEC2725 Carboxylic Acid: Degradation of HEC5725 Carboxylic Acid (HEC71 SO) in Three Soils Under Aerobic Conditions: Lab Project Number: M125
1146

- O: MR522/01. Unpublished study prepared by Bayer Ag. 54 p. 45865311 Unacceptable Material balances were incomplete as the soil extract were analyzed for parent HEC

5725

- carboxylic acid.

835.4200 Anaerobic Soil
Metabolism No data No

--

835.4300 Aerobic Aquatic
Metabolism Hellpointner, E. (2002) Anaerobic Aquatic Degradation and Metabolism of HEC5725: Lab Project Number:

M152006

- 3: MR

- 406/01: HPO

- 225. Unpublished study prepared by Bayer Ag. 76 p. 45865312

Acceptable No The registrant responded (MRID 46925806) to the deficiencies in the data
evaluation report and the acceptability of the aerobic aquatic study submitted in support of the fluoxastrobin registration (MRID 458653

- 12 and 13). The study was
reevaluated and determined to be acceptable as EFED does not expect fluoxastrobin to sorb to the glass t est apparatus to a sufficient degree to affect the study results, as demonstrated by the
material balance. Allan, J. (2006) Response to the EPA Data Evaluation Reports on the Acceptability of the Fluoxastrobin Aerobic and Anaerobic Aquatic Studies. Project Number: HEC083006. Unpublished study prepared by Bayer CropScience LP. 7 p. 46925806

835.4400 Anaerobic Aquatic
Metabolism Brumhard, B.; Oi, M. (2002) Aerobic Degradation and Metabolism of (Methoxyiminotolyl

- Ring

- UL

- (Carbon 14))
HEC 5725 in the Water/Sediment System: Lab Project
Number: M15 1 0903

- 9: MR

- 396/01: M151 0903

- 9. Unpublished study prepared by Bayer Ag. 75 p. 45865313 Acceptable No

### 36

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

Durando, J. (2008) Fluoxastrobin

- Myclobutanil SC: Primary Eye Irritation Study in Rabbits. Project Number: 26083, P324. Unpublished study prepared by Product Safety Laboratories. 16 p. 46925806

835.1230
835.1240 Adsorption/ desorption and Leaching Hein, W. (2000) Adsorption/Desorption of (Phenyl

- UL

- (Carbon 14)) HEC 7155 (Deschlorophenyl HEC 5725) on Four Different Soils: Lab Project Number: BAY33: FM776. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fuer Landwirtschaft. 44 p. 45865314 Acceptable

No

-- Fent, G. (1998) Adsorption/Desorption of (Methoxyiminotolyl

- Ring

- UL

- (Carbon 14)) HEC5725 on Four Different Soils: Lab Project Number: BAY27: FM767. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fuer Landwirtschaft. 46 p. 45865315 Acceptable

Stupp, H. (2001) Adsorption and Desorption of HEC5725

- Carboxylic Acid in Soil: Lab Project Number: MR411

- 01:
M1311123

- 2: MR41 1/01. Unpublished study prepared by Bayer Ag. 63 p. 45865316 Acceptable

Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC57275

- Carboxylic Acid on Soil Using High Performance Liquid Chromatography (HPLC): Lab Project Number: M 138 1130

- 7: 247/01: MR247

- 01. Unpublished study prepared by Bayer Ag. 34 p. 45865401 Supplemental

835.6100 Terrestrial Field Dissipation Schramel, O. (2001) Dissipation of HEC5725 (100 EC) in Soil under Field Conditions: France, Germany, Great Britain, Italy: Lab Project Number: R812390: R812404: R812412. Unpublished study prepared by Bayer Ag. 184

p. 45865317 Supplemental No P atterns of formation and decline of the
fluoxastrobin transformation products were not adequately determined. The only transformation product detected in the soil, HEC5725

- E

- des

- chlorophenyl, was not detected above the LOQ at five of the eight test sites and was not detected
at more than three s ampling intervals at any of the test sites.

### 37

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in California Soil, 1999: Final Report: Lab Project Number: AG990009: F99568

- 001: 99.109. Unpublished study prepared by Batt elle Memorial Institute and Plant Services, Inc. 236 p. 45865318 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in Georgia Soil, 1999: Final Report: Lab Project Number: AG990010: F99541

- 001: HC022102. Unpublished study prepared by Battelle Memorial Institute and Bayer Research Farm. 197 p. 45865319 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in New York Soil, 1999: Final Report: Lab Project Number: AG990011: F99565

- 001: AR99352. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 241 p. 45865320 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in New York Soil, 1999: Final Report: Lab Project Number: HC022104: 200217: AG990012. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 174 p. 45865321 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in Washington Soil, 1999: Final Report: Lab Project Number: AG990013: F99538

- 001:
99

- 40. Unpublished study prepared by Battelle Memorial Institute and Qualls Agricultural Laboratories,
Inc. 191 p. 45865322 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in California Turf, 1999: Final Report: Lab Project Number: AG990014: HC022701: 200219. Unpublished study prepared by Battelle
Memorial Institute and Plant Sciences, Inc. 253 p. 45865323 Acceptable See footnote 1.

### 38

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in New York Turf, 1999: Final Report: Lab Project Number: AG990015: F99565

- 001:
HC022702. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 261 p. 45865324 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in Manitoba Soil, 1999: Final Report: Lab Project Number: AG990024: F99559

- 001: HC022107. Unpublished study prepared by Battelle
Memorial Institute and Enviro

- Quest. 188 p. 45865325 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 5725 in Prince Edward Island Soil, 1999: Final Report: Lab Project Number: AG990025:
F99564

- 001: HC022106. Unpublished study prepared by Battelle Memorial Institute and Atlantic AgriTech. 173 p. 45865326 Supplemental

Storage Stability Andre, J. (2005) Freezer Storage Stability of HEC 5725 and Relevant Metabolites on Soil from California, Washington, Georgia, New York, Manitoba, and Prince Edward Island. Project Number: 201275, AG010002. Unpublished study prepared by Battelle. 102 p. 46569701 Acceptable No While the current storage stability data are not adequate, the assumption is that
fluoxastrobin is stable.

Schramel, O. (2001) Determination of the Storage Stability of HEC5725

- E

- Isomer, HEC5725

- Z

- Isomer,
HEC5725

- E

- Des

- Chlororphenyl and HEC5725

- E/Z

Carboxylic Acid in Soil After a Storage Period of 14 Months: Lab Project Number: P64190032: M R

- 646199:
MR

- 646

- 99. Unpublished study prepared by Bayer Ag. 85 p. 45865332 na No

### 39

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

835.6200 Aquatic Field Dissipation Culligan, J. (2009) Aquatic Field Soil Dissipation of Evito 480 SC Fungicide Following Application to Flooded Rice Field in Arkansas. Project Number: ARAP/07A/004. Unpublished study prepared by Ag Research Associates and ALS Laboratory Group, Environmental. 185 p. 48532004 Upgradable no Several study deficiencies were noted including: the storage stability data reported were insufficient to determine the stability of fluoxastrobin in test site water and soil; soil cores were not sectioned into increments; a plot history
was not report ed; meteorological data for the study period were not provided; and an independent laboratory method validation was not performed.

850.6100
850. 7 100 Analytical
Method in Soil Schramel, O. (2001) Residue Analytical Method 00611 (MR

- 645/99) for the Determination of HEC 5725

- E

Isomer, HEC 5725

- Z

- Isomer, HEC

- 5725

- E

- Des

Chlorophenyl and HEC 5725

- E/Z

- Carboxylic Acid in Soil by HPLC

- MS/MS: Lab Project Number: P 60190031: MR

645/99: 00611. Unpublished study prepared by Bayer AG. 74 p. 45865328 Acceptable

n o Environmental Chemistry Method

Bauer, M. (2002) Independent Laboratory Validation of Bayer Method 00611 "Residue Analytical Method for the
Determination of HEC 5725

- E

- Isomer, HEC 5725

- Z

Isomer, HEC

- 5725

- E

- Des

- Chlorophenyl and HEC 5725

- E/Z

- Carboxylic Acid in Soil by HPLC

- MS/MS": Lab Project Number: AG000082: HC112101: 200317. Unpublished study prepared by Battelle. 85 p. 45865329 Acceptable Independent laboratory validation of

MRID 45865328.

Analytical
Method in

Water Sommer, H. (1999) Method for Determination of HEC 5725 and HEC 7155 in Test Water from Aquatic Toxicity Test by HPLC: Lab Project Number: P 604 97052: 109230: 00579. Unpublished study prepared by Bayer Ag. 15 p. 45865330 Acceptable

yes Results are to support aquatic toxicity testing.

Sommer, H. (2001) Enforcement Methods for Determination of HEC 5725 in Drinking and Surface Water by HPLC

- MS/MS: Lab Project Number: P 684

017047: MR

- 201/01: 00692. Unpublished study prepared by Bayer Ag. 27 p. 45865331 Acceptable No independent laboratory validation study has been provided to support this environmental chemistry method (enforcement method).

### 40

OCSPP
Guideline Da ta Requirement Citation Submitted
Studies (MRID) Study
Classifications Are data
needed? Comments

165

- 4
850.1730 Fish Bio

concentration Dorgerloh, M.; Weber, E. (2001) (Carbon 14)

- HEC 5725

-- Bioconcentration and Biotransfor mation in Bluegill (Lepomis macrochirus) under Flow

- Through Conditions: Lab Project Number: DOM 20032: E 244 1857

- 1: DOMA 20032. Unpublished study prepared by Bayer Ag. 160 p.

45865421 Supplemental no T he bioaccumul ation and
biotransformation of fluoxastrobin we re conducted in separate experiments using bluegill sunfish at different life stages; therefore, it is uncertain whether the
formation and distribution of transformation products in the adult fish
tested in the biotransformation experiment would be the same for the juvenile fish tested in the bioaccumulation experiment. In addition, no storage stability data for fish tissues were submitted, although the fish samples were stored frozen for up to 6 months prior to extraction and analysis. BCF
values were calculated based on total radioactivity. 1. The supplemental storage stability study (MRID 46569701) indicating fluoxastrobin and relevant transformation products are stable (37

- 38 months) in the test soils.

### 41

Table VI

. 2 . Aquatic Ecological Effects Data for Fluoxastrobin

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

850.1010 Aquatic
Invertebrate Acute Toxicity

,

F reshwater Heimbach, F. (1999) Acute Toxicity of HEC 5725 (tech.) to Water Fleas (Daphnia magna): Lab Project Number: HBF/DM 211:

E 320 1674

- 3. Unpublished study prepared by Bayer Ag. 47 p. 45865406 (TGAI ) Acceptable

No D aphnia magna

Dorgerloh, M.; Sommer, H. (2002) Acute Toxicity of HEC 5725 (E:Z; 65:35) to Water Fleas (Daphnia magna): Lab Project
Number: E 320 2187

- 3: DOMA 21071. Unpublished study prepared by Bayer Ag. 51 p. 45865407 E:Z (65:35) Acceptable

Hendel, B.; Sommer, H. (2001) Acute Toxicity of HEC 5725

- Carboxylic Acid (tech.) to Water Fleas (Daphnia magna): Lab Project Number: E 320 1976

- 8: HDB/DM 249. Unpublished study prepared by Bayer Ag. 26 p. 45865408 (HEC 7180) Acceptable HEC 5725

- Carboxylic Acid Daphnia magna

Hendel, B. (2000) Acute Toxicity of HEC

5725

- Deschlorophenyl to Water Fleas (Daphnia magna): Lab Project Number: E

320 1800

- 4: HDB/DM 227. Unpublished study prepared by Bayer Ag. 24 p. 45865409 (HEC 7155) Acceptable HEC 5725

- Deschlorophenyl Daphnia magna

van Wijngaarden, R.; (2003) Acute Toxicity
of Fluoxastrobin to Freshwater Invertebrates: Final Report. Project Number: ALT/RW/2003/1, ALTERRA/RW/2003/1. Unpublished study prepared by Alterra, Green World Research.
93 p. 46080402 (TGAI) Supplemental This study was conducted with aquatic invertebrate species ( Daphnia gr. galeata

, Simocephalus vetulus

, Acanthocyclops venustus

, Gammarus pulex

, Asellus aquaticus

, Chaoborus obscuripes , and Cloeon dipterum )

.

### 42

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

van Wijngaarden, R. (2003) Screening
Studies on the Effects of Fluoxastrobin to Freshwater Invertebrates. Project Number: F03069. Unpublished study prepared by Alterra, Green World Research. 12 p. 46080401 (TGAI) Invalid No solvent control was tested.

850.1025

I nvertebrate

Acute T oxicity

Estuarine /
Saltwater Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC

5725: A 96

- Hour Shell Deposition Test with the Eastern Oyster (Crassostrea virginica): Lab Project Number: 99

- B

- 133: HC831501:
2357

- BR. Unpublished stud y prepared by T.R. Wilbury Laboratories, Inc. 30 p. 45865410 (TGAI) Supplemental No New shell growth in the solvent control did not satisfy the mini mum requirement of 2.0 mm at 1.5 ± 1.3 mm; however, the shell deposition observed in the negative control was
2.1 ± 0.9 mm ; eastern oyster

850.1035
850.1045 Boeri, R.; Wyskiel, D.; Ward, T. (2002) HEC
5725: A 96

- Hour Flow

- Through Acute Toxicity Test with the Saltwater Mysid, (Americamysis bahia): Lab Project Number:

99

- B

- 131: HC833101: 2358

- BR. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 31 p. 45865411 (TGAI) Acceptable No Salt Water Mysid

850.1075 F ish Acute Toxicity

, F reshwater Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Bluegill (Lepomis macrochirus) in a Static Test: Lab Project
Number: E 252 1696

- 1: DOMA 99089: 00579. Unpublished study prepared by Bayer Ag. 48 p. 45865412 (TGAI) Acceptable

No Bluegill

Dorgerloh, M. (2000) HEC 5725 Acute Toxicity (96 Hours) to Common Carp (Cyprinus carpio) in a Static Test: Lab Project Number: DOMA 20011: E
28601782

- 4. Unpublished study prepared by Bayer Ag. 37 p. 45865413 (TGAI) Supplemental

### 43

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test: Lab Project Number: E 250 1605

- 9: DOMA 99065: 00579. Unpublished study prepared by Bayer Ag. 48 p. 45865414 (TGAI) Acceptable Rainbow Trout

Dorgerloh, M.; Sommer, H. (2001) HEC
5725

- Carboxylic Acid

-- Acute Toxicity (96 Hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test (Limit Test): Lab Project Number: E 280 2104

- 7: DOMA 21020: 00683. Unpublished study prepared by Bayer Ag. 41 p. 45865415 (HEC 7180) Supplemental Rainb ow Trout; the study was conducted at only one concentration (95.7 mg/L) , and the mean

- measured
concentration was below the limit level of 100 ppm.

Dorgerloh, M. (2000) HEC 5725

- Deschlorophenyl

-- Acute Toxicity (96 Hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test: Lab Project Number: E 280
1761

- 5: DOMA 20012: 00579. Unpublished study prepared by Bayer Ag. 46 p. 45865416 (HEC 7155) Acceptable Rainbow Trout

850.1075 F ish Acute Toxicity

, Estuarine /Salt

water Kern, M.; Woodard, D.; Mattern, G. (2002) Acute Toxicity of HEC 5725 (Technical) to the Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions: Lab Project Number: HC830901: 110322. Unpublished study prepared by Bayer CropScience. 30 p. 45865417 (TGAI) Supplemental No The solubility limit under the test conditions (salt water) were not provided; however, the practical solubility is expected to be much higher than the tested
concentrations. Sheepshead Minnow

850.1300 Freshwater
Invertebrate

Life Cycle Hendel, B. (2000) Influence of HEC 5725 (tech.) on the Reproduction Rate of Water Fleas (Daphnia magna): Lab Project
Number: E 321 1798

- 1: HDB/RDM 64. Unpublished study prepared by Bayer Ag. 80 p. 45865418 (TGAI ) Acceptable No Daphnia magna

### 44

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

850.1350 Estuarine /
Saltwater
Invertebrates

Life Cycle Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC
5725: A Flow

- Through Life Cycle Toxicity Test with the Saltwater Mysid (Americamysis bahia): Lab Project Number:

99

- B

- 132: HC843101: 2359

- BR. Unpublished study prepared by T.R. Wilbury La boratories, Inc. 48 p. 45865419 (TGAI) Supplemental No Salt Water Mysid; following pairing, male survival data were not reported;
second

- generation mysids were not monitored daily for 4 days for survival, development, and behavior, and terminal growth measurements were not provided by gender

850.1735/

OECD 218 Benthic
Invertebrates (Freshwater, Prolonged) Ortego, L. (2006) Fluoxastrobin Ecotoxicological Studies

- Response to Deficiencies. Project Number: HEC082906. Unpublished study prepared by Bayer
C ropScience LP. 7 p. 46925805 (TGAI) na Yes This is not a study but rather is a

r esponse to study deficiencies identified by EPA. The document was submitted by the registrant.

850.1740 Benthic
Invertebrates (Marine, 10

- Day) Ortego, L. (2006) Fluoxastrobin Ecotoxicological Studies

- Response to Deficiencies. Project Number: HEC082906. Unpublished study prepared by Bayer CropScience LP. 7 p. 46925805 (TGAI) na Yes This is not a study but rather is a response to study deficiencies identified by EPA. The document was submitted by the registrant.

850.1400 F ish Early

- Life

Stage

, F reshwater Scheerbaum, D. (2001) HEC 5725

-- Fish (Rainbow Trout), Early

- Life Stage Toxicity Test, Under Flow

- Through Conditions: (Final Report): Lab Project Number: 991028BD: FSR69122. Unpublished study prepared by
Dr. U. Noack

- Laboratorium. 84 p. 45865420 (TGAI) Supplemental No Rainbow Trout; although reduction in time to swim up and increase in yolk sacs were observed at statistically significant levels, it appears that these effects are transient, and in the case of time to swim up, not dose=dependent. Because no

treatment

- rela ted effects were observed in any of the other endpoints, a LOAEC values was not
established.

### 45

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

850.4400 Aquatic P lant Toxicity

, Vascular Dorgerloh, M. (2001) HEC 5725

-- Toxicity (7 Days) to Lemna gibba G3: Lab Project
Number: E 412 1602

- 6: DOM 20017: MR

238/00. Unpublished study prepared by Bayer Ag. 31 p. 45865429 (TGAI) Acceptable

No Kern, M.; Lam, C. (2002) Toxicity of HEC 5725 Technical to Duckweed (Lemna gibba G3): Lab Project Number: HC883701: 200340. Unpublished study prepared by Bayer CropScience. 36 p. 45865430 (TGAI) Acceptable

850.45 00 Aquatic P lant Toxicity

,

Algal Dorgerloh, M. (2000) HEC 5725

-- Influence on the Growth of the Green Alga, Selenastrum capricornutum: Lab Project
Number: E 323 1609

- 4: DOM 99061. Unpublished study prepared by Bayer Ag. 38 p. 45865431 (TGAI) Acceptable

No Dorgerloh, M.; Sommer, H. (2001) HEC
5725

-- Carboxylic Acid

-- Influence on the Growth of the Green Alga, Selenastrum capricornutum: Lab Project Number: E 323
1878

- 2: DOM 20061: MR

- 110/01. Unpublished study prepared by Bayer Ag. 47 p. 45865432 (HEC 7180) Acceptable

Dorgerloh, M. (2000) HEC 5725

-- Deschlorophenyl

-- Influence on the Growth of the Green Alga, Selenastrum capricornutum: Lab Project Number: E 323
1756

- 7: DOM 20015: MR

- 245/00. Unpublished study prepared by Bayer Ag. 30 p. 45865501 (HEC 7155) Supplemental This study was conducted at only one
concentration (98.8 mg a.i./L; solubility note reported) and that
concentration elicited a reduction in cell density which exceeded 10%. The
test concentration is more 100x higher than estimated environmental
concentrations.

### 46

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

850.1735 Whole
Sediment:

Acut e Freshwater
Invertebrates Thomas, S.; Krueger, H.; Kendall, T. (2012) (Carbon 14)

- Fluoxastrobin: A 10

- Day Survival and Growth Toxicity Test with the Midge (Chironomus tentans) Using Spiked Sediment: Final Report. Project Number: 443A/147A. Unpublished study prepared by Wildlife International Ltd. 72p. 49317701 In Review No

850.1740 Whole
Sediment:
Acute Marine
Invertebrates Thomas, S.; Krueger, H.; Kendall, T.; et al. (2012) (Carbon 14)

- Fluoxastrobin: A 10

- Day Survival Toxicity Test with the Marine Amphipod (Leptocheirus plumulosus) Using Spiked Sediment: Final Report. Project Number: 443A/148. Unpublished study prepared by Wildlife In ternational, Ltd. 68p. 49317702 In Review No

850.1770/

850.1760 Whole
Sediment:

Chronic
Invertebrates

Freshwater
and Marine No data Yes

Non

guideline Development and Emergence
sediment

dwelling ( Chironomus

riparius ) Hendel, B. (2000) Influence of HEC 5725 (tech.) on Developement and Emergence of Larvae of Chironomus riparius in a Water Sediment System: Lab Project Number: E
416 1774

- 0: HDB/CH 41: MR

- 277/00. Unpublished study prepared by Bayer Ag. 45 p. 45865505 (TGAI) Invalid na Overlying and pore wat er concentrations were not analyzed at every nominal level during the study; therefore, the toxicity values do not represent actual exposure
concentrations

.

### 47

OCSPP
Guideline Data Requirement
Test Material Citation Submitted
Studies (MRID) Study
Classifications Are data needed
for risk
assessment? Comments

Non

guideline Chronic Indoor Microcosm, amphipod Liebig, M. (2003) A Long

- Term Indoor
Microcosm Study on the Toxicity of Fluoxastrobin (EC 100) to the Amphipod Gammarus pulex L. in a Natural Water

Sediment System. Project Number: P1MG. Unpublished study prepared by ECT Oekotoxikologie Gmbh. 135 p. 46404901 (TEP) Supplemental na The results of this study are not comparable to the chronic freshwater
invertebrate studies because reproductive endpoints were not
measured. Concentrations in the sediment and pore

- water were not measured.

Non

guideline Midge Chronic Toxicity Dorgerloh, M.; Sommer, H. (2001) Influence
of HEC 5725

-- Carboxylic Acid on Development and Emergence of Larvae of Chironomus riparius in a Water Sediment System: Lab Project Number: E 416 2091

- 3: DOM 21061: 00683. Unpublished study prepared by Bayer Ag. 56 p. 4586550 6 (HEC 7180) Invalid na

### 48

Table VI

. 3 . Terrestrial Ecological Effects Data for Fluoxastrobin

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

850.2100 Avian Acute Oral Toxicity , bobwhite Barfknecht, R. (2000)
HEC 5725 Techn. Ai: Acute Oral Toxicity for Bobwhite Quail: Lab Project Number: E 292
1560

- 5: BAR/LD032. Unpublished study prepared by Bayer Ag. 38

p. 45865422 (TGAI) A cceptable No No data are available for passerine ; however, toxicity of
fluoxastrobin to other avian species do not suggest effects are likely.

850.2200 Avian dietary toxicity Barfknecht, R. (2001)
HEC 5725 Techn.: 5

- Day Dietary LC50 for Bobwhite Quail (Colinus virginianus): Lab Project
Number: E 295 1558

- 5: BAR/LC007. Unpublished study prepared by Bayer Ag. 34 p. 45865423 (TGAI) Acceptable

No Barfknecht, R. (2001)
HEC 5725 Techn.: 5

- Day Dietary LC50 for Mallard Duck (Anas platyrhynchos): Lab Project Number: E 297
1559

- 8: BAR/LC 009. Unpublished study prepared by Bayer Ag. 35

p. 45865424 (TGAI) Acceptable

### 49

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

850.2300 Avian reproduction Frieling, W. (2001) Reproduction Study in Bobwhite Quail with HEC
5725 Techn.: (By Dietary Admixture): Lab Project
Number: 259774. Unpublished study prepared by Notox B.V. 211 p. 45865425 (TGAI) Acceptable

No Bowers, L.; Stoughton, T. (2003) Effect of
Technical HEC 5725 on Mallard Reproduction: Lab Project Number:
HC740801: 200084. Unpublished study prepared by Bayer CropScience. 129 p. 45865426 (TGAI) Acceptable

Non

- guideline Earthworm toxicity,
Subchronic LC 50 Meisner, P. (2000) Acute Toxicity of HEC 5725
Techn. Ai: to Earthworms (Eisenia fetida): Lab Project Number: E 310

1771

- 0: MPE/RG 318/00. Unpublished study prepared by Bayer Ag. 19

p. 45865502 (TGAI) Supplemental N A

### 50

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

Meisner, P. (2000) Acute Toxicity of HEC 5725

-- Deschlorophenyl to Earthworms (Eisenia fetida): Lab Project
Number: E 310 1759

- 6: MPE/RG 335/00. Unpublished study prepared by Bayer Ag. 19

p. 45865503 (HEC 7155) Supplemental

Non

- guideline Earthworm toxicity, reproduction and growth Luehrs, U. (2002) HEC

5725

-- Deschlorophenyl: Effects on Reproduction
and Growth of Earthworms (Eisenia fetida) in Artificial Soil: Lab Project Number: 14661022. Unpublished study prepared by Ibacon GmbH. 36 p. 45865504 (HEC 7155) Supplemental NA Study type is not typically required.

Non

- guideline Avian inhalation No data No Based on STIR analysis, risks through inhalation pathway are not expected.

870.1100 Acute Mammalian
Oral (rat) Krotlinger, F. (1996) HEC 5725: Study for Acute Oral Toxicity in Rats: Lab Project Number: 25231:
T8060660: 109158. Unpublished study prepared by Bayer Ag. 29

p. 45865612 Acceptable No

### 51

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

870.3800 Mammalian Reproduction (rat) Young, A.; Christenson, W. (2001) A Two

Generation Reproductive Toxicity Study with HEC
5725 in the Wistar Rat: Lab Project Number: 99

- R72

- BW: 110249. Unpublished study prepared by Bayer Corporation and Pathology Associates International. 1473 p. 45865634 (TGAI) Acceptable No

850.3020 Honey Bee Adult

Acute Oral And Contact Toxicity Bruhnke, C. (2000) HEC

5725 A.I.

-- Acute Effects on the Honeybee Apis mellifera (Hymenoptera, Apidae); Limit Test: Lab Project Number:
990222BN: IBA64041. Unpublished study prepared by Noack

Laboratorium. 30 p. 45865427 (TGAI) Acceptable No Used in place of non

- target insect testing (880.4350)

850.3030 Honey Bee Toxicity
Of Residues On Foliage No data No This study is not triggered based on the reported endpoint in the honey bee adult acute contact study.

Non

- guideline
OECD TG 213 Honey Bee Adult Acute Oral Toxicity No data No Tier 1 toxicity test. See note
above

.
Non

- guideline
OECD TG 237 Honey Bee Larvae Acute Oral Toxicity No data Yes Tier 1 toxicity test; TGAI

### 52

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

Non

- guideline Honey Bee Larvae Chronic Oral Toxicity No data Yes Tier 1 toxicity test; TGAI

Non

- guideline Honey Bee Adult Chronic Oral Toxicity No data Yes Tier 1 toxicity test; TGAI

Non

- guideline
OECD
Guidance 75 Semi

- Field Testing
For Pollinators No data Yes Tier 2 test contingent on results
of tier 1 tes ts and screening level residues; TEP

Non

- guideline Field Trial Of
Residues In Pollen

a nd Nectar No data Yes Tier 2 test contingent on results
of tier 1 tes ts and screening level residues; TEP

850.3040 Field Testing For
Pollinators No data Yes Tier 3 test contingent on results
of earlier t iers of testing; TEP

850.4100 Terrestrial Plant Toxicity, Seedling Emergence Bowers, L. (2003) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using HEC 5725 SC 480: Lab Project
Number: 200313:
HC451601: HC451602.

Unpublished study prepared by Bayer CropScience. 97 p. 45865428 (TEP) Acceptable

No

48520001 (TEP) Invalid Study is invalid for lettuce, onion, and ryegrass due to poor emergence in the controls.

### 53

OCSPP Guideline Data Requirement
Test Material Citation Submitted Studies (MRID) Study Classifications Are data needed
for risk
assessment? Comments

Greenland, R. (2011) Tier

1 Seedling Emergence Study Assessing
Fluoxastrobin 480 SC Formulation. Project Number: SARS/10/60. Unpublished study prepared by Stewart Agricultural Research Services, Inc. 51 p. Supplemental Study is supplemental for remaining species due to excessively high temperature during the study that may have stressed the plants.

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor Greenland, R. (2011) Tier 1 Vegetative Vigor Study Assessing Fluoxastrobin
480 SC Formulation. Project Number: SARS/10/61. Unpublished study prepared by Stewart Agricultural Research Services, Inc. 51 p. 48520002 (TEP) Acceptable No

### 54

Bowers, L. (2003) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using HEC 5725 SC 480: Lab Project
Number: 200313:
HC451601: HC451602. Unpublished study prepared by Bayer CropScience. 97 p. 45865428 (TEP) Acceptable

### 55

VII. REFERENCES (GENERAL)

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs

. January 23, 2004 . Office of Pesticide Programs. Office of Prevention, Pesticides, and Toxic
Substances

. Available at : http://www.epa.gov/espp/consultation/ecorisk

- overview.pdf

USEPA. 2014. ECOTOX User Guide: ECOTOXicology Database System . Version 4.0. Available: http:/www.epa.gov/ecotox/

Bohaty. R, Hetrick, J. Drinking Water Assessment to Support Fluoxastrobin Use on Sweet Cron and Wheat January 13, 2010 (DP Barcode: 366189)

Bohaty, R. Drinking Water Assessment for Fluoxastrobin Use on Squash/Cucumber (crop subgroup 9B)
and New In

- Furrow and Banded Uses on Tuberous and Corm Vegetables (crop subgroup 1C) as
well as Peanut December 15, 2010 (DP Barcode: D379114, D384377)

Boh a ty, R. Drinking Water Assessment for Fluoxastrobin Use on Melon and Sorghum February 5, 2013 (DP Barcode: D403757)

Bohaty, R. Revised Drinking Water Assessment for fluoxastrobin Use on Rice May 8, 2012 (DP Barcode 401613)

Nguyen, T., Pease, A. EFED Ecological Risk Assessment for the Section 3 Registration of the New Chemical Fluoxastrobin for Uses on Peanuts, Potato and Tuber Ve getables, Leaf Petioles subgroup, Fruiting vegetables, Turf, and Seed Treatments for Potato, Peanut, and Turf July 27, 2004 (DP Barcode: D289104)

Panger, M. Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on Melon (Crop Subgroup 9a) and Sorghum March 19, 2013 (DP Barcode: D403574)

Panger, M., Bohaty, R., Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on Rice May 8, 2012 (DP Barcode: D392988)

Panger, M., Bohaty, R ., Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on Squash/Cucumber Subgroup 9B and the Proposed Label Amendment to Add Infurrow and Banded Applications for TuberICorm Vegetables and Peanuts January 10, 2011 (DP Barcode: D379112, D384375)

Crk, T., Hetrick, J. Ecological Risk Assessment for the Section 3 New Use Registration of Fluoxastrobin on new food uses (berry subgroup; field corn and soybean; and, sweet corn and wheat) July 17,
2009 (DP Barcode: D356983, D357729, D366187)

Shanaman, Lucy, Frankenberry, M. Section 3 Regist ration for Proposed New Use of Fluoxastrobin on
Ornamental Plants August 29, 2008 (DP Barcode: D349270, D349282)

### 56

APPENDIX A

. CHEMICAL IDENTIFICATION OF FLUOXASTROBIN TRANSFORMATION PRODUCTS

Company Code Major/ Minor

Tra nsformation
Product Study Observed Chemical Structure

HEC 5725

- oxazepine Major Aquatic Photolysis

MRIDs 45865306, 45865403

HEC 7339
HEC 5725

- phenoxy

- amino

pyrimidine Minor Aquatic Photolysis

MRIDs 45865306, 45865403

HEC 7155,
HEC5725

- E

- des

chlorophenyl Major Aerobic Soil Metabolism

MRIDs 45865309, 45865310 Aerobic Aquatic Metabolism

MRID 45865313

HEC 7180,
HEC5725

- carboxylic acid Minor Aerobic Soil Metabolism

MRIDs 45865309, 45865310 Aerobic Aquatic Metabolism

MRID 45865313

HEC5725

- E

- 4

- hydroxyphenyl Minor Aerobic Soil Metabolism

MRIDs 45865309, 45865310

HEC 7334 Minor Aerobic Aquatic Metabolism

MRID 45865313

### 57

Company Code Major/ Minor

Tra nsformation
Product Study Observed Chemical Structure

HEC 7338

HEC 5725

- amide Minor Aerobic Aquatic Metabolism

MRID 45865313

### 58



### APPENDIX B . SIP ANALYSIS RESULTS

Table B. 1. 

### SIP Inputs ( solubility at 20  ̊C at pH 7 of 2.292 mg/L )

Parameter Value
Chemical name Fluoxastrobin Solubility (in water at 25 o C; mg/L) 2.559

Mammalian LD 50 (mg/kg

- bw) 2000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 70 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 461 Avian test species mallard duck Body weight (g) of "other" avian species Mineau scaling factor

Mallard NOAEC (mg/kg

- diet) 590 Bobwhite quail NOAEC (mg/kg

diet) 1029 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

### 59

Table 2. Mammalian Results
Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.4401 0.4401 Adjusted toxicity value (mg/kg

- bw) 1538.3211 53.8412 Ratio of exposure to toxicity 0.0003 0.0082

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results
Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 2.0728 2.0728 Adjusted toxicity value (mg/kg

- bw) 36419.0000 29.2714 Ratio of exposure to acute toxicity 0.0001 0.0708

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Drinking water exposure alone is NOT a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals.

### 60



### APPENDIX C . STIR ANALYSIS RESULTS

The S creening T ool for I nhalation R isk (STIR v.1.0, November 19, 2010) was used to calculate an upper bound estimate of exposure using fluoxastrobin ’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the “six

- pack” of core studies, wh ich are a series of six guideline studies that are submitted to the Registration Division of the Office of Pesticide Programs for technical and formulated products of a pesticide [acute oral LD 50 

### >2,000 mg a.i./kg

- bw, rat (MRID 45902118); acute
inhalation LC 50 

### > 5.05 mg/L, rat (MRID 45902124)] as well as the most sensitive acute oral avian toxicity endpoint [LD 50 

### > 2,000 mg a.i./kg

- bw, bobwhite quail (MRID 45902309)]. Based on the results of the STIR model, inhalation exposure alone was not determined to be a potential pathway of concern for avian or mammalian species on an acute basis for either ground or aerial spray types. Detailed information about STIR v.1.0, as well as the tool, can be found on the EPA’s website at: http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial

.



# Input

Application and Chemical Information

Enter Chemical Name Fluoxastrobin
Enter Chemical Use Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 458.83 Enter Chemical Vapor Pressure (mmHg) 4.12E

- 12 Enter Application Rate (lb a.i./acre) 2

Toxicity Properties

**Bird** Enter Lowest Bird Oral LD 50 (mg/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178
**Mammal** Enter Lowest Rat Oral LD 50 (mg/kg bw) 2000 Enter Lowest Rat Inhalation LC 50 (mg/L) 4.9 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35 **NOTE**: When entering values, press the "Enter" key in order to update linked cells.

### 61



# Output

Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.02E

- 07 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 1.28E

- 08
Adjusted Inhalation LD 50 2.73E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 4.68E

- 10 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.11E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 7.74E

- 03 Exposure not Likely Significant



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.02E

- 07 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 1.61E

- 08
Adjusted Inhalation LD 50 2.92E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 5.51E

- 11 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.66E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 9.11E

- 04 Exposure not Likely Significant