### Page 2 of 39 

# Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking

Water Exposure Assessments in Support of the

Registration Review of Flucarbazone Sodium

CAS Registry Number: 181274

- 17

- 9

PC Code: 114009

Prepared by: Elyssa Arnold , Biologist Richard Shamblen, Biologist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division

Environmental Risk Branch I I 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 Reviewed by: Kristina Garber, Senior Biologist Greg Orrick , Environmental Scientist Jean Holmes, DVM, MPH, Risk Assessment Process Leader Brian Anderson, Branch Chief



### October 31

, 201 3

### Page 3 of 39 

## T ABLE OF 

## C ONTENTS



### 1. EXECUTIVE SUMMARY

................................ ................................ ................................ .... 4

2. INTRODUCTION

................................ ................................ ................................ .................. 4

3. USE CHARACTERIZATION

................................ ................................ ................................ 5

4. CONCLUSIONS FROM PREVIOUS ASSESSMENTS

................................ ....................... 5

4.1. Ecological Risk Assessments

................................ ................................ ........................... 5

4.2. Drinking Water Exposure Assessments

................................ ................................ ........... 6

4.3. Clean Water Act Programs

................................ ................................ ............................... 6

5. ENVIRONMENTAL FATE AND TRANSPORT

................................ ................................ . 6

5.1. Transformation Products

................................ ................................ ................................ .. 8

6. R ECEPTORS

................................ ................................ ................................ ........................ 15

6.1. Effects to Aquatic Organisms

................................ ................................ ........................ 15

6.2. Effects to Terrestrial Organisms

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

6.3. Ecological Incidents

................................ ................................ ................................ ....... 18

7. EXP OSURE PATHWAYS OF CONCERN

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

8. ANALYSIS PLAN

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

8.1. Stressors of Concern

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

8.2. M easures of Exposure

................................ ................................ ................................ .... 21

8.3. Measures of Effect

................................ ................................ ................................ ......... 21

8.4. Endangered Species Assessments

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

8.5. Endocrine Disruptor Screening Program

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

9. PRELIMINARY IDENTIFICATION OF DATA GAPS

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

9.1. Environmental Fate

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

9.2. Effects

................................ ................................ ................................ ............................. 24

10. REFERENCES

................................ ................................ ................................ .................. 27 Appendix A. SIP and STIR Results

................................ ................................ .............................. 35 Appendix B. ECOSAR Estimates for Flucarbazone Sodium and its Degradates

......................... 37

### Page 4 of 39 

### 1. EXECUTIVE SUMMARY

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem

formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of flucarbazone sodium (PC 114009; CAS Regi stry Number 181274

- 17

- 9 ) . The problem formulation describes the methods planned for the completion of drinking water and ecological r isk assessments and provide s an

ove rview of the environmental fate, ecological effects , and potential risks associated wit h the use

of flucarbazone sodium . The problem formulation also addresses uncertain ties unique to risk

assessment of flucarbazone sodium . This document identifies additional studies that would be beneficial to the conduct of an ecological risk assessment. Major findings include:

Environmental fate and transport data gaps :

• 835.4100 Aerobic soil metabolism

– Guideline

- compliant data are needed for two

additional soils

.

Ecotoxicology data gap s:

• None

2. INTRODUCTION

Flucarbazone sodium is a selective, post

- e mergent herbicide used to control a variety of grasses

and broadleaf weeds. Registered uses include wheat, turf, and conifer tree nurseries. Flucarbazone sodium (Sodium salt 4,5

- dihydro

- 3

- methoxy

- 4

- methyl

- 5

- oxo

- N

- [2

- trifluoromethoxy)phenyl]solfonyl]

- H

- 1, 2,4

- triazole

- 1

- carboxamide; CAS No. 181274

- 17

- 9; PC

code 114009 ) is a sulfonyamino

- carbonyl

- triazolinone herbicide (Wood

, 2007; Ware and

Whitacre

, 2004) that dissociates to an anion (flucarbazone) in the presence of moisture

. The

terms flucarbazone and fl ucarbazone sodium will be used interchangeably in this document. The

mode of action for sulfonyamino

- carbonyl

- triazolinone herbicides is the inhibition of branched chain amino acid biosynthesis through the inhibition of an enzyme called acetolactate synth etase (ALS) (Ware and Whitacre

, 2004).

T here is concern for surface and ground water contamination due to the high solubility, mobility

, and persistence properties of flucarbazone, and its sulfonamide and sulfonic acid degradates. N o water quality monitoring data for flucarbazone has been identified.

EFED evaluated the most recent ecological risk assessments for flucarbazone sodium in

association with the most recent toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registration review.

Recen t risk assessments include a 2009 assessment for the use of flucarbazone sodium on turf and conifer tree nurseries (DP 357819) . In deter mining if new data or updated assessments will

be needed for registration review, EFED considered the latest Agency science policies and risk assessment methodologies.

### Page 5 of 39 

### 3. USE CHARACTERIZATION

Flucarbazone sodium was first registered in the United States i n 2000 for use as an herbicide on wheat. Registered uses now include wheat, turf, and conifer tree nurseries. Between 2004 and 2011, approximately 30,000 pounds of flucarbazone sodium were applied to wheat annually

, accounting for an average of five perc ent and a maximum of 10 percent of the U.S. wheat crop. Use was also reported in this time period on fallow land, which is not a registered use of flucarbazone sodium (USEPA, 2013). Flucarbazone sodium is formulated as an emulsifiable

concentrate, suspen sion concentrate, and water dispersible granule s

. Products registered for use

on wheat include co

- formulations with the herbicides chlorsulfuron and fluroxypyr 1

- methylheptyl ester. Applications may be made by air or ground boom. The maximum single appl ication rate is 0.026 lb acid equivalents (ae)/acre

.

Table 1 details the registered use patterns for flucarbazone sodium. EFED will use application

parameter s that result in maximum exposure scenarios for a give n use for the registration review

risk assessment.

Table 1 . Use Site and Application Information for Flucarbazone Sodium

Use Site Formulation Type 1 Max imum App

. Rate (lbs ae/Acre) Maximum

Annual

Rate Maximum No. of Apps

per Year Minimum App. Interval (days) Application

Methods

Conifers (Plantations/ Nurseries) EC 0.025 0.025 NS 30 Ground

Grasses G rown for S eed 2 SC/L 0.026 0.026 1 NS Ground or Aerial

Ornamental

Lawns and T urf 3 EC 0.025 0.025 NS 30 Ground

Wheat EC, SC/L,

WD G 0.02 6 0.02 6 1 NS Ground or

Aerial

Abbreviations: NS

- Not Specified ; App.

- Application

1 EC

- Emulsifiable Concentrate; SC/L

- Suspension Concentrate/Liquid; WDG

- Water Dispersible Granules (dry flowable)

2 Special Local Needs registrations for Idaho, Minnesota, Oregon, and Washington only

3 Includes golf course fairways and roughs, seed and sod production fields, commercial and residential sites (including homes, schools, playgrounds, parks, recreational areas and sports fields, common areas)



### 4. CONCLUSIONS FROM PREVIOUS ASSESSMENTS

4.1. Ecological Risk Assessments

The Agency has conducted three ecological risk assessments on flucarbazone sodium that serve

as a basis for this problem formulation , including an assessment for the initial registration for use

on wheat (USEPA, 2000 a ), an asse ssment for aerial applications to wheat (USEPA, 2004) , and

an assessment for new uses on turf and conifer tree nurseries (USEPA, 2009 a )

. Maximum estimated aquatic exposure concentrations in the 2009 assessment for peak, 21

- day , and 60

- day exposures were 0 .996 , 0.9 86 , and 0. 968 μg/L , respectively. The only identified direct risk concern in previous assessments was for terrestrial plan ts. The major ecological risk conclusions

from these assessments are summarized in Table 2

.

### Page 6 of 39 Table 2 . Summary of Risk Concerns Identified for Flucarbazone Sodium in Previous Assessments

Birds Mammals Terr.

Plants Terr.

Inverts Fish Bioaccum

ulation Aquatic

Inverts Aquatic

Plants Ground W ater
Contamination Persistence Degradates

of Concern



### No No Yes No No 1 

### No No 1 

### No No No Yes &

No 2

Abbreviations: Terr.

- Terrestrial

1 No data were available for the assessment of risk to estuarine/marine invertebrates or fish.

2 For the ecological risk assessment, no degradates of concern were identified. For the drinking water assessment, degradates containing the sulfonamide moiety were of concern

.



### 4.2. Drinking Water Exposure Assessments

A drinking water exposure assessment for flucarbazone sodium was conducted for the initial registration for use on wheat at 0. 0 25 lb ae/acre (USEPA, 2000 b ). Exposure estimates of

flucarbazone sodium residues of concern from use on wheat were 1.45 μg/L (1

- i n

- 10

- year peak ), and 1.44 μg/L ( 1

- in

- 10

- year annual mean and 30

- year mean) for surface water and a maximum of 50 μg/L for ground water. The residues of concern included in the calculations were the parent and all degradates containing the sulfonamide moie ty ( i.e. , MKH 6562 Sulfonamide) for consistency with the animal enforcement analytical method

. The new uses on turf and conifer tree nurseries registered in 2009 had the same application rate and therefore a new drinking

water assessment was not conducted for them (USEPA, 2009 b ). No ground or surface water monitoring data were available.

Due to the persiste nce of flucarbazone degradates, SCI

- GROW was not used to estimate ground water exposure for total residues. Instead, the screening value of 50 μg/L was estimated, which

represents the concentration of flucarbazone residues in the soil pore water of the top 1

- foot of soil immediately post

- application . T his value is a n upper limit to the amount of chemical that could be found in ground water (USEPA, 2 000 b )

.

4.3. Clean Water Act Programs

Flucarbazone sodium is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. No Total Maximum Daily Load (TMDL) criteria have been developed for fl ucarbazone sodium . Aquatic benchmarks have not been

established for flucarbazone sodium . Any data submitted or otherwise located as part of the registration review process may be used to develop aquatic life benchmarks if applicable.

5. ENVIRONMENTAL F ATE AND TRANSPORT

Table 3 summarizes select chemical properties and environmental fate and transport

characteristics of f lucarbazone sodium

. H alf

- life da ta are presented for hydrolysis and aqueous and soil photolysis studies. Aerobic soil and water and anaerobic aquatic metabolism disappearance time (DT 50 

### ) data were calculated with PestDF using R v.2.14.1 software

. Aerobic aquatic disappearanc e rates are classified as provisional whi le the study (MRID 48648501) is

under review. As warranted, m etabolism rates were adjusted for temperature ( 25°C ) ( USEPA, 2010).

### Page 7 of 39 

### In the presence of moisture, f lucarbazone sodium dissociat es to an anion (flucarbazo ne) and

sodium

. As an anion, flucarbazone is very soluble (44 g/L) and not likely to bioaccumulate. Because of its low vapor pressure and Henry’s law constant, volatilization from soil or water is not expected to be a major route of dissipation.

With ha lf

- lives greater than 210 days, f lucarbazone sodium is stable to hydrolysis ( pH 

## 5, 7, and 9) and photolysis in both water and soil. However, the herbicide does photolyze in a non

- sterile pond water environment with a half

- life of approximately 61 days. After becoming incorporated

into soil s
, aerobic in

- situ degradation of the herbicide range s from 23 days to 224 days, varying by soil type

. The herbicide disappearance rates ranging from 13 to 32 days on four separate soils in field dissipation studies ap pear to support the laboratory data. These field d issipation half

lives were due to both leaching and biodegradation

.

In an ana erobic aquatic environment

, flucarbazone is moderately persistent with calculated metabolism rates of 73 to 657 days. Although classified as “ pr ovisional” data while the study is under review, the aerobic aquatic disappearance rates range from 54 to 307 days.

Table 3 : Chemical Properties and Environmental Fate Characteristics of Flucarbazone Sodium

Parameter Value 1 Description Source (MRID)

Selected Physical/Chemical Parameters

Molecular Mass (Molecular Formula) 418. 3 g/mol ( C 12 H 10 F 3 N 4 Na O 6 S

– Na + ) -- 44865801

Vapor pressure (20°C) < 7.5 x 10 - 12 torr N on

- volatile under field

conditions 44865801

Aqueous solubility
(20 ° C) 44 ,000 m g/L Soluble 44865801

Henry’s Law Constant (20°C) <9.9 x 10 - 1 7 [ atm x m 3 ] /

Mole Essentially non

- volatile 44865801

Log octanol

- to

- water partition

coefficient (log K OW ) pH 4:

- 0.89 pH 7:

- 1.8 4 pH 9:

- 1. 88 Not likely to

bioaccumulate 44865801

Acid dissociation constant (pKa) 1.9 Anion ic 44865801

Persistence

Hydrolysis : H alf

- life
(25±1 ° C) pH 5: 520 d pH 7: 520 d pH 9: 750 d Not a major degradation pathway 44848851

Aqueous Photolysis: H alf

- life
(25±1 ° C) Phoenix, AZ:

Sterile Buffer pH 7: 680 d

Pond Water pH 7.9: 61 d Not a major degradation pathway 44848902/

44865802

Soil Photolysis: Half life
(25±1 ° C) Phoenix, AZ:

210 d Not a major degradation pathway 4484890 1

Aerobic Soil Metabolism: DT 50 (21±1°C) 36 d
[ 27 d ] North Dakota

S andy Loam S oil 44848903

### Page 8 of 39 Parameter Value 1 Description Source (MRID)

[DT 50 adjusted to 25±1°C ] 30 d
[ 23 d] 44848904

296 d
[ 224 d] Manitoba Sandy Loam 44848905

Aerobic Aquatic Metabolism 2 : DT 50 (21±1°C)
[DT 50 adjusted to 25±1°C ] 71 d [54 d]

405 d [307 d] -- 48648501

Anaerobic Aquatic Metabolism:

D T 50 [DT 50 adjusted to 25±1°C ] 657 d (5 °C ) [164 d] -- 44848909

73 d (21°C) [55 d] -- 44848910

Mobility

Freundlich soil

- water partition coefficients (K F )

Organic carbon

- normalized Freundlich coefficients (K FOC ) 0.24, 0.57, 0.31, 0.30, 0.02

l/k g

11, 20, 15, 12, 12 l/ k g Mobile 44848912

Field Dissipation

Terrestrial Field Dissipation:

DT 50 L eaching d epth Plot 1: 13 d (0

- 7.5 cm depth); Leached to 22.5cm depth Gray Wooded

loam soil 44848922/

45083705 Plot 2:

14 d (0

- 7.5 cm depth) Leached to 22.5cm depth

Plot 1: 31 d (0

- 7.5 cm depth); Leached to 30.0 cm depth Orthic Dark Brown clay loam soil 44848924 /

4508370 3 Plot 2: 19 d (0

- 7.5 cm depth); Leached to 30.0 cm depth

18 d (0

– 15 cm depth) ; Leached to 75.0 cm depth Timmerman sandy loam soil 46223703

32 d (0

– 15 cm depth) ; Leached to 15.0 cm depth Tillman fine sandy loam soil 46223704

Abbreviations: ° C

- degrees Celsius; DT

- disappearance time; l

- liters; k g

- kilograms

1 Reported values are rounded to 2 significant figures.

2 Study data is classified as provisional while study (MRID 48648501) is in review. The reported half

- life data are presented in italics and represent two systems evaluated during the study.



### 5.1. Transformation Products

Table 4 s ummarizes the transformation products of f lucarbazone sodium and the maximum

amounts formed by the degradation pathway

. M ajor ( ≥ 10%) degradates of f lucarbazone sodium

identified in submitted environmental fate studies include MKH 6562 sulfonamide, MKH 6562

### Page 9 of 39 

### sulfonic acid, O

- desmethyl MKH 6562 NMT

, N

- methyl

- triazolinone ( NMT), and carbon

dioxide

. The sulfonamide forms up to 89% of the ap plied, O

- desmethyl MKH 6562 NMT forms up to 32% of the applied, and the other major degradates are less prominent. M inor (<%10) degradates include MKH 6562 sulfonyl urea, N,O

- dimethyltriazoline (NODT), polar acid

, and unknown or unidentified compounds

.

MKH 6562 s ulfonamide and MKH 6562 sulfonic acid are resistant to metabolism

. T he O

desmethyl flucarbazone degradate rapidly hydrolyzes to NODT, which then degrades rapidly to

NMT. NMT is either immobilized in the soil or metabolized to CO 2 

### and nitrogen compounds.

MKH 6562 s ulfonamide, MKH 6562 sulfonic acid, and NODT degradates are very mobile in all

soils

.

Because of the high solubility and mobility of flucarbazone sodium and the high mobility and persistence of its sulfonamide degradate , both surface and ground water contamination may

occur following flucarbazone sodium application

. None of the degradates have been identified as ecological residues of concern in previous risk assessments. The previous drinking water

assessment included the parent and the degradate MKH 6562 s ulfonamide as residues of

concern.

### Page 10 of 39 Table 4 : Flucarbazone S odium and Major Environmental Degradates

Code Name/

Synonym Chemical Name Chemical

Structure Study
Type Reference
(MRID) 1 Maximum

Percent Recovery 2

, 3

( time period ) Final

Percent

Recover y 2

, 3

( study length )

PARENT

M K H 6562 /

Flucarbazone

sodium Name:

Sodium salt of 4,5

- dihydro

3

- methoxy

- 4

- methyl

- 5

- oxo

N

- [2

- [(trifluoromethoxy) phenyl] sulfonyl]

- 1H

- 1,2,4

- triazole

- 1

- carboxamide

CAS No.:

181274

- 17

- 9

Formula:

C 12 H 10 F 3 N 4 NaO 6 S

Smiles String: [Na+].O=S(=O)(/N=C( \ [O

- ])N1/N=C(/OC)N(C1=O)C) c2ccccc2OC(F)(F)F

Molecular Weight: 418.3 g/mol

TRANSFORMATION PRODUCTS

### Page 11 of 39 Code Name/

Synonym Chemical Name Chemical

Structure Study
Type Reference
(MRID) 1 Maximum

Percent Recovery 2

, 3

( time period ) Final

Percent

Recover y 2

, 3

( study length )

MKH 6562

Sulfonamide Name:

2

- (Trifluoromethoxy)

- benzene

- sulfonamide

- 3,4,6

- d3

Formula:

C 7 H 6 F 3 NO 3 S

Smiles String: c1(S(N)(=O)=O)c(OC(F)(F) F)cccc1

Molecular Weight: 241.2 g/mol Hydrolysis : pH 5 pH 7 pH 9 44848851 4.2 % (30 d)

3.9 % (30 d)

4.0 % (30 d) 4.2 % (30 d)

3.9 % (30 d)

4.0 % (30 d) Aqueous Photolysis : Sterile

– Dark

Sterile

– Light

Pond

– Dark

Pond

- Light 44848902/

44865802 2.2 % (31.1 d)

5.1 % (31.1 d)

2.2 % (32.0 d)

24 % (32.0 d) 2.2% (31 d) 5.1% (31 d)

2.2 % (32 d)

24 % (32 d)

Aerobic

Soil

Metabolism 44848903 69% (181 & 272 d) 67% (366 d)

44848905 46% (272 d) 41% (366 d)

Anaerobic

Aquatic

Metabolism 44848909 S 49 % (275 d) 68 % (365 d)

44848910 89 % (367 d) 8 9 % (367 d)

Terrestrial

Field Dissipation 44848922/

45083705 35% (59 d)

40% (332 d) 29% (505 d)

30% (505 d)

44848924/

45083703 24% (402 d)

21% (28 d) 8% (502 d)

11% (502 d)

44848925 S 7% (14 d) <LOQ (456 d)

44848926 S 33% (28 d) 7% (367 d)

MKH6562

Sulfonic Acid Name:

2

- (Trifluoromethoxy)

- benzene

- sulfonic acid

Formula:

C 7 H 5 F 3 O 4 S

Smiles String: O=S(=O)(c1ccccc1OC(F)(F )F)O

Molecular Weight: 242.2 g/mol Hydrolysis : pH 5 pH7 pH9 44848851 0.6 % (0 d)

0.6 % (1 d & 14 d)

0. 6 % (7 d) 0.5% (30 d)

0.5 % (30 d)

0.4 % (30 d) Aqueous Photolysis : Sterile

– Dark

Sterile

– Light

Pond

– Dark

Pond

- Light 44848902/

44865802 0.8% (13 d ) 1.0% (31 d)

1.1 % (8 d) 1.3% (32 d) 0.8% (31 d)

1.0 % (31 d)

0.8 % (32 d)

1.3 % (32 d)

Aerobic

Soil

Metabolism 44848903 11% (272 d) 10% (366 d)

44848905 6% (366 d) 6% (366 d)

Anaerobic

Aquatic

Metabolism 44848909 NR NR

44848910 NR NR

Terrestrial Field

Dissipation 44848922/

45083705 6% (456 d) <1% (505d )

<LOQ% (

-- d) <LOQ (502 d)

### Page 12 of 39 Code Name/

Synonym Chemical Name Chemical

Structure Study
Type Reference
(MRID) 1 Maximum

Percent Recovery 2

, 3

( time period ) Final

Percent

Recover y 2

, 3

( study length )

44848924/

45083703 11% (91 d) <LOQ (502 d)

8% (91 d) 11% (502 d)

44848925 <LOQ (

-- d) <LOQ (456 d)

44848926 6% (63 d) <LOQ (367 d)

O

- desmethyl

MKH 6562

NMT Name:

4

- methyl

- 3,5

- dioxo

- N

- [[2

- (trifluoromethoxy)phenyl]su lfonyl]

- 1,2,4

- triazolidine

- 1

- carboxamide

Formula:

C 11 H 9 F 3 N 4 O 6 S

Smiles String: c1(S(=O)(=O)NC(=O)N2C( =O)N(C)C(=O)N2)c(OC(F) (F)F)cccc1

Molecular Weight:

382.3 g/mol Aerobic

Soil

Metabolism 44848904 15% (2 m) 2.5% (12 m)

Terrestrial

Field Dissipation 44848922/

45083705 30% (10 d)

32% (28 d) NA (505 d) NA (505 d)

44848924/

45083703 13 % (3 d)

10 % (3 d) NA (502 d) NA (502 d )

44848925 <LOQ <LOQ

44848926 8% (28 d) <LOQ (367 d)

NODT Name: N,O

- dimethyltriazoline

Formula:

C 4 H 7 N 3 O 2

Smiles String: C1(=O)N(C)C(OC)=NN1

Molecular W eight:

129.1 g/mol Aerobic

Soil

Metabolism 44848904 4.7% (1 m) ND (12 m)

### Page 1 3 of 39 Code Name/

Synonym Chemical Name Chemical

Structure Study
Type Reference
(MRID) 1 Maximum

Percent Recovery 2

, 3

( time period ) Final

Percent

Recover y 2

, 3

( study length )

NMT Name:

N

- methyl

- triazolinone

Formula:

C 3 H 5 N 3 O 2

Smiles String: C1(=O)N(C)C(=O)NN1

Molec ular Weight:

115.1 g/mol Aerobic

Soil

Metabolism 44848904 14% (2 m) 3.9% (12 m)

MKH 6562 Sulfonyl

- urea Name:

2

- Trifluoromethoxy

benzenesulfonyl urea

Formula:

C 8 H 7 F 3 N 2 O 4 S

Smiles String: c1(S(=O)(=O)NC(N)=O)c( OC(F)(F)F)cccc1

Molecular Weight:

284.2 g/mol Aerobic

Soil

Metabolism 44848903 2% (272 d) 2% (366 d)

44848905 <1% (90 d) 2% (366 d)

CO 2 Name:

Carbon dioxide

CAS No:

124

- 38

- 9

Smiles String: C(=O)=O

Molecular Weight: 44.0 g/mol Aerobic

Soil

Metabolism 44848903 4% (272 d) 4% (366 d)

44848904 24 % (12 m) 24 % (12 m)

44848905 1% (366 d) 1% (366 d)

Anaerobic

Aquatic

Metabolism 44848909 <1% (275 d) <1% (365 d)

44848910 <1% (275 d) <1% (365 d)

### Page 14 of 39 Code Name/

Synonym Chemical Name Chemical

Structure Study
Type Reference
(MRID) 1 Maximum

Percent Recovery 2

, 3

( time period ) Final

Percent

Recover y 2

, 3

( study length )

Polar

Acid -- -- Aqueous Photolysis : Sterile

– Dark

Sterile

– Light

Pond

– Dark

Pond

- Light 44848902/

44865802 NR

NR

0.00 % (

-- d)

5 .3% (32 d) NR

NR

0.00 % (

-- d) 5.3% (32 d)

Unknown/

Unidentified/ Other -- -- Hydrolysis : pH 5 pH7 pH9 44848851 0. 8% (1 d)

0.7 % (7 d)

0.7 % (7 d) 0.6% (30 d)

0.7 % (30 d)

0.4 % (30 d)

Aerobic

Soil

Metabolism 44848903 2% (272 d) 2% (366 d)

44848904 0.4% (2 m) ND (12 m)

44848905 1% (42 d) ND (366 d)

Anaerobic

Aquatic

Metabolism 44848909 <1% (275 d) <1% (365 d)

44848910 <1% (275 d) <1% (365 d)

Abbreviations: d

- day; m

- month; LOQ

- Level of Quantitation; NA

- not analyzed; ND

- n ot detected; NR

- not reported

. 1 When two MRID numbers are separated by “/”, this indicates that the second number is an addendum to the initial study.

2 V alues are reported to two significant figures.

3 Bolded values indicate a major degradate was formed.

### Page 15 of 39 

### 6. RECEPTORS

Acute (short

- term) and chronic (long

- term) toxicity information is characterized based on registrant

- submitted studies and a comprehensive review of the open literature on

flucarbazone sodium

. Reported ecological incidents associated with flucarbazone sod ium

are also summarized below.

Table 5 and Table 6 provide summaries of the aquatic and terrestrial taxonomic groups, respectively, and surrogate species tested to characterize the potential acute and chronic ecological effects of flucarbazone

. Toxicity data in these tables were converted from measured active ingredient (flucarbazone sodium, 418.28 g/mol) to acid equivalents (flucarbazone, 395.29 g/mol) using a molecular weight conversion. Based on the available ecotoxicity information, flucarbaz one is practically non

- toxic to aquatic and

terrestrial animals on an acute exposure basis and orders of magnitude more toxic to vascular plants, which is expected for an herbicide. Relative to vascular aquatic plants,

non

- vascular aquatic plants are order s of magnitude less sensitive, which is consistent

with the mode of action of this herbicide. Effects to growth and/or reproduction were also observed in birds, mammals, and fish that were exposed to flucarbazone on a chronic

basis

.

6.1. Effects to Aquatic Organisms

Table 5 . Summary of Aquatic Toxicity Studies for Flucarbazone Sodium

Taxonomic

Group Study Type Surrogate Species Toxicity Value ( mg/L measured acid equivalent ) Acute Toxicity

Classification Source (MRID)

Freshwater

fish 1 Acute Rainbow t rout ( Oncorhynchus mykiss ) LC 50 > 9 1.4 Practically

nontoxic 44848936

Bluegill s unfish ( Lepomis

macrochirus ) LC 50 > 93.8 Practically

nontoxic 4484893 7

Chronic (Early

Life

Stage) Rainbow t rout NOAEC / LOAEC

= 1.18 / 2.60 Endpoint:

deformities -- 4484893 8

Freshwater

invertebrates Acute Daphnia magna EC 50 > 103 Practically

nontoxic 4484893 4

Chronic Daphnia magna NOAEC / LOAEC

= 109 / >109 -- 4484893 5

Estuarine/

marine fish Acute Sheepshead m innow ( Cyprinodon variegatus ) LC 50 = >1 33 2 Practically

nontoxic 2 48549305

Estuarine/

marine

invertebrates Acute Eastern o yster ( Crassostrea virginica ) EC 50 = > 78 2 Practically

nontoxic 2 4854930 3

### Page 16 of 39 Taxonomic

Group Study Type Surrogate Species Toxicity Value ( mg/L measured acid equivalent ) Acute Toxicity

Classification Source (MRID)

Acute Mysid s hrimp ( Mysidopsis bahia ) LC 50 = >1 13 2 Practically

nontoxic 2 4854930 4

Aquatic plants and algae Vascular Duckweed ( Lemna gibba ) NOAEC = 0.005 0

EC 50 = 0.01 16 Very highly

toxic 44848950

Non

vascular Green a lgae ( Pseudokirchneriella subcapitata ) NOAEC = 2.37

EC 50 = 5.26 Moderately

toxic 44848946

Blue

- green a lgae ( Anabaena flos

aquae ) NOAEC = 5.13

EC 50 = 1 1 Moderately

toxic 4484894 7

Freshwater d iatom ( Navicula pelliculosa ) NOAEC = 109

EC 50 = >1 09 Practically

nontoxic 4484894 8

Marine d iatom ( Skeletonema

costatum ) NOAEC = 8 4

. 3

EC 50 = >84

. 3 Practically

nontoxic 4484894 9

1 Freshwater fish may be used as surrogates for aquatic

- phase amphibians.

2 Provisional toxicity values and classifications; studies are currently undergoing review.



### 6.2. Effects to Terrestrial Organisms

Table 6

. Summary of Terrestrial Toxicity Studies for Flucarbazone Sodium

Taxonomic

Group Study Type Surrogate Species Toxicity Value (measured acid

equivalent ) Acute Toxicity

Classification Source (MRID)

Birds 1 Acute Bobwhite quail ( Colinus virginianus ) LD 50 > 1890 mg/kg Practically

nontoxic 44848939

Zebra f inch ( Poephila

guttata ) LD 50 >1890 mg/kg 2 Practically

nontoxic 2 48549306

Sub

- acute dietary Bobwhite quail LC 50 >4391 ppm Practically

nontoxic 44848941

Mallard d uck ( Anas platyrhynchus ) LC 50 >4696 ppm Practically

nontoxic 4484894 3

Chronic Bobwhite quail NOAEC / LOAEC =

1239 / >1 239 ppm -- 44848945

Mallard duck NOAEC / LOAEC = 211

/ 1 059 ppm Endpoints: reduced adult body weights, hatching of fertile eggs, number of 3

- week embryos per pen -- 4484894 4

### Page 17 of 39 Taxonomic

Group Study Type Surrogate Species Toxicity Value (measured acid

equivalent ) Acute Toxicity

Classification Source (MRID)

Mammals Acute Oral Laboratory rat ( Rattus norvegicus ) LD 50 > 4725 mg/kg

- bw Practically

nontoxic 44848716

Chronic Laboratory rat NOAEC / LOAEC =

271 / 756 mg/kg

- bw /day (M)

321 / 937 mg/kg

- b w /day (F ) Endpoints: reduced pup weights, decreased liver weight in male pups, marbled liver, air

- filled

stomachs -- 44848745, 44848746,

44848747

Insects Acute

contact Honey bee ( Apis mellifera

L. ) LD 50 = >189 μg/bee Practically

nontoxic 44848933

Acute oral Honey bee LD 50 = > 421 μg/bee

-- 44848933

Terrestrial plants 3 Seedling Emergence Monocot

– rye NOAEC = 0.000624 lb/A

EC 25 = 0.000927 lb/A Endpoint: seedling dry weight -- 44848929

Dicot

– canola NOAEC = 0.000211 lb/A

EC 25 = 0.000455 lb/A Endpoint: seedling dry weight -- 44848929

Vegetative Vigor Monocot

- onion NOAEC = 0.000211 lb/A

EC 25 = 0.000379 lb/A Endpoint: plant dry weight -- 44848929

Dicot

– buckwheat NOAEC = 0.000211 lb/A

EC 25 = 0.000337 lb/A Endpoint: plant dry weight -- 44848929

Abbreviations: F

- female; M

- male

1 Birds may be used as surrogates for terrestrial

- phase amphibians and reptiles.

2 Provisional toxicity values and classifications; studies are currently undergoing review.

3 Note: These endpoints were re

- calculated for the most recent risk assessment (USEPA, 2009 a )

.



### Degradate Toxicity Data

Data on the toxicity of the flucarbazone sodium degradate MKH 6562 sulfonamide to aquatic and terrestrial plants have been submitted to the Agency. The EC 50 

### for duckweed ( Lemna gibba ) was >4.85 mg ai /L in a range

- finding study (MRID 44848951). Limit tests for seedling emergence and vegetative vigor for the monocot oat and dicots lentil and sugar beet resulted in EC 25 

### values of >2.4x10 - 4 

### lb ai/A and no signs of phytotoxicity for all species and endpoints evaluated (MRID s 45694901 and 46103701). These data suggest that MKH 6562 sulfonamide is less toxic to terrestrial and aquatic vascular plants

than the parent compound

.

### Page 18 of 39 

### 6.3. Ecological Incidents

Three databases were searched for ecological incidents possibly associated with

flucarbazone sodium: the Ecological Incident Information System ( EIIS )

, the aggregate
incident database

, and t he Avian Monitoring System ( AIMS )

. The EIIS is an OPP

database that hou ses ecological incidents that have been reported to the Agency. When available, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to

the incid ent, and results of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the incident resulted from pesticide exposure. The AIMS database is administered by the American Bird Conservancy and contains publicly available data on reported avian incidents involving pesticides. Many of the incidents listed in this database are also in

the EIIS. The aggregate incident database reports provide count s of ecological incidents considered “minor.” These are reported to the Agency quarterly by registrants.

EIIS returned 23 terrestrial plant incidents attributed to flucarbazone sodium use , 18 incidents with “probable” certainty and 5 with “possible” cert ainty (USEPA, 2007 a )

. The reported incidents for flucarbazone sodium involved 1 8 uses that are currently registered and two in which the legality of the use was not specified. With the exception of the two incidents involving potato crops, all reported i ncidents were to treated fields. Three additional incidents were reported involving use on corn, one of which was reported as a registered use and two in which the legality of the use was not specified. However, flucarbazone sodium has never been registe red for use on corn, so these

incidents should be considered the result of misuses of the herbicide. See Table 7 for a list of the incidents reported in EIIS. As of November 8, 2012, AIMS identified no ecological incidents involving flucarbazone sodium.

Table 7

. Incidents Rep orted in EIIS for Flucarbazone Sodium

Incident # Date County State Certainty

Code 1 Legality

Code 2 Formul

ation 3 App.

Method Total Magnitude

Crop Treated: Corn

I012211

- 002 6/20/2001 Fremont ID 2 RU DF N/R Plant damage to 50%

of treated corn

I012177

- 006 9/10/2001 McCone MT 2 UN N/R N/R Stunted growth in 60%

of treated corn

I013425

- 005 8/23/2002 Roosevelt MT 3 UN WDG Broadcast Plant damage to 1 1 00

acres of treated corn

Crop Treated: Wheat

I012211

- 001 6/21/2001 Washington OR 2 RU DF N/R Plant damage to 50%

of treated wheat

I012177

- 005 9/24/2001 Washington OR 2 RU DF N/R Stunted growth in

100% of treated wheat

I013218

- 007 6/27/2002 Cavalier ND 2 RU DF Broadcast Plant damage to 100%

of treated wheat

I013312

- 006 7/17/2002 Pondera MT 3 RU WDG Broadcast Plant damage to 72%

of 200 acres of treated

wheat

I013218

- 010 7/17/2002 Chouteau MT 3 RU DF N/R Plant damage to 100%

of treated wheat

I013218

- 011 7/18/2002 Gallatin MT 3 RU DF Broadcast Plant damage to 100%

### Page 19 of 39 Incident # Date County State Certainty

Code 1 Legality

Code 2 Formul

ation 3 App.

Method Total Magnitude

of treated wheat

I013312

- 007 7/22/2002 Dawson MT 3 RU WDG Broadcast Plant damage to 200

acres of treated wheat

I013312

- 003 7/24/2002 Fremont ID 3 RU WDG Broadcast Plant damage to 500

acres of treated wheat

I013312

- 004 7/31/2002 Dawson MT 3 RU WDG Broadcast Plant damage to 580

acres of treated wheat

I013312

- 005 8/7/2002 Liberty MT 3 RU WDG Broadcast Plant damage to 645 of

720 acres of treated

wheat

I013218

- 009 8/29/2002 Cavalier ND 3 RU DF Broadcast Plant damage to 65% of crop of treated

wheat

I013218

- 008 8/29/2002 Pondera MT 3 RU DF Broadcast Plant damage to 100%

of treated wheat

I013425

- 004 9/5/2002 Gallatin MT 3 RU WDG Broadcast Plant damage to 180

acres of treated wheat

Crop Treated: Spring Wheat

I013425

- 003 7/18/2002 Teton MT 3 RU WDG Broadcast Plant damage to 727

acres of treated spring

wheat

I013425

- 010 7/22/2002 Power ID 3 RU DF Broadcast Plant damage to 147

acres of treated spring

wheat

I013425

- 006 7/26/2002 McLean ND 3 RU DF Broadcast Plant damage to 145

acres of treated spring

wheat

I013425

- 007 8/11/2002 Chouteau MT 3 RU DF Broadcast Plant damage to 160

acres of treated spring

wheat

Crop Treated: Winter Wheat

I013425

- 008 9/22/2002 Blaine MT 3 RU DF Broadcast Plant damage to 440

acres of treated winter

wheat

Crop Treated: Not Recorded

I013425

- 009 9/19/2002 Fremont ID 3 UN DF N/R Plant damage to 30

acres of potato crop from carryover

I013548

- 015 10/2/2002 Fremont ID 3 UN WDG N/R Plant damage to 302

acres of potato crop from carryover Abbreviations: App.

- Application

1 Certainty Code: 0=Unrelated, 1=Unlikely, 2=Possible, 3=Probable, 4=Highly Probable. N/R=Not Reported

2 Legality Code: RU=Registered Use, M=Misuse, MA=Misuse (Accidental), MI=Misuse (Intentional),

U N =Unknown

3 WDG=Water Dispersible Granule, DF=Dry Flowable



### The number of documented incidents in the EIIS is believed to be a very small fraction of total mortality caused by pesticides for a variety of reasons. Incident reports for non

target organisms typically provide information only on mortality events and plant damage. Sub

- lethal effects in organisms such as abnormal behavior, reduced growth and/or impaired reproduction are rarely reported, except for phyto toxic effects in

### Page 20 of 39 

### terrestrial plants. An absence of reports does not necessarily equate to an absence of incidents given the nature of the incident reporting.

In addition to the incidents recorded in the EIIS, registrants have reported minor

flucarbazone sodium incidents to the Agency in aggregate reports. Registrants reported 39 minor plant incidents between 2001 and 2002. All minor incidents occurred with use of the water dispersible granule formulation. Thirty

- one of the 39 minor incidents

occurred b etween July 1 and September 30. Unless additional information on these aggregated incidents becomes available, they will be assumed to be representative of registered uses of flucarbazone sodium in the risk assessment.

7. EXPOSURE PATHWAYS OF CONCERN

The e nvironmental fate properties of flucarbazone sodium indicate that direct spray, spray drift, runoff, and leaching represent potential transport mechanisms of th is chemical to aquatic and terrestrial organisms. Drinking water and inhalation exposure pathways were screened for this problem formulation using the SIP (Screening Imbibition Program ) and STIR (Screening Tool for Inhalation Risk) screening methods (see Appendix A. SIP and STIR Results for details). Potential exposure pathways of concern were found for flucarbazone sodium for drinking water but not for inhalation.

SIP and STIR are described in detail at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm

.

Because flucarbazone sodium is persistent and can leach into ground water, there is a potential for adverse effects on terrestrial plants when irrigated with a ground water

de rived source, particularly in areas where the soil is permeable and/or ground water is

shallow.

8. ANALYSIS PLAN

8.1. Stressors of Concern

Ecological Risk Assessment

The stressor of ecological concern is the parent compound only. As described in Section

6 , MKH 6562 sulfonamide toxicity data suggest that the primary degradates of flucarbazone sodium do not retain the mode of action of the parent compo und. ECOSAR estimates for all degradates suggest low toxicity and support the use of the parent compound as the sole stressor of concern (see Appendix B

. ECOSAR Estimates for Flucarbazone Sodium and its Degradates )

.

Drinking Water Assessment

The drinking water assessments conducted to support future human health risk

assessments of flucarbazone sodium will incorporate model estimates and available monitoring data fo r flucarbazone sodium residues of concern, which are the parent

### Page 21 of 39 

### compound and the degradate containing the sulfonamide moiety ( USEPA, 2000 b ), in surface and ground waters. E stimates of exposure to the total residues of flucarbazone sodium containing the sulfonamide moiety will be calculated for consistency with the animal enforcement analytical method. The flucarbazone sodium residues of concern may be reevaluated pending re ceipt and review of additional environmental fate and toxicity data for flucarbazone sodium and its degradates.

8.2. Measures of Exposure

EFED will use standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm

.

Screening level calculations have suggested that the drinking water exposure pathway may be significant for flucarbazone sodium for acute and chronic risk to terrestrial

wildlife

. The acute exposure risk was conservatively estimated using non

- definitive endpoints for both mammals and birds and , based on the lack of any effects observed in the studies, it is unlikely that drinking water exposure to flucarbazone poses a risk to terrestrial wildlife on an acute basis. Chronic risk to terrestrial wildlife through the drinking water exposure pathwa y may be further considered at t he time of the risk

assessment

.

Estimated concentrations of mobile and persistent herbicides, such as flucarbazone, in irrigation water may be calculated to determine potential risk to irrigated crops. As detailed above, t he persistence, mobility, and solubility of flucarbazone indicate the potential for the chemical to reach ground and surface water.

N o water quality monitoring data have been identified for flucarbazone sodium. A preliminary review of four national w ater monitoring programs was completed for this problem formulation

, including : 1) the California Department of Pesticide Regulation (CDPR) surface water database 1 

### (searched 8/9/2013); 2) the USGS NAWQA surface and ground water database 2 

### (searched 8/9/2013 ); 3) the USEPA STORET Data Warehouse 3


### (searched 8/9/2013); and, 4) the USDA Pesticide Data Program drinking water monitoring survey 4 

### (searched 8/14/2013). If monitoring data become available, they will

be considered at the time of the assessment.

8.3. Measur es of Effect

Toxi city data presented in Section 6 of this problem formulation will be used to calculate risk quotients. Any additional information submitted by the registrant or found in the

1 http://www.cdpr.ca.gov/docs/emon/surfwtr/surfcont.htm

, 2 http://infotrek.er.usgs.gov/apex/f?p=136:1:0::NO:::

3 http://www.epa.gov/storet/

4 http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateG&navID=&rightNav 1=&topNav=&leftNav=ScienceandLaboratories&page=PDPDownloadData/Reports&resultType=&acct=p estcddataprg

### Page 22 of 39 

### open literature prior to conduct of the risk asse ssment will also be considered. The open literature studies are identified using EPA’s ECOTOXicology database ( ECOTOX) (USEPA, 2007 b ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and w ildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in

structure and functional charact eristics of the affected communities.

8.4. Endangered Species Assessments

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

. The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/endanger/lits tatus/riskasses.htm

.

8.5. Endocrine Disruptor Screening Program

Flucarbazone sodium was not included in the first group of 67 chemicals issued an order

t o conduct Tier 1 EDSP testing nor in the second group of 109 chemicals. For additional information the EDSP program, visit http://www.epa.gov/endo/

.

9. PRELIMINARY IDENTIFICATION OF DATA GAPS

9.1. Environmental Fate

Table 8 i dentifies 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 to support risk assessment

. A erobic soil metabolism data for two additional soils are needed , since only two soils were studied in submitted reports . An additional aerobic

aquat ic metabolism study is also needed if the submitted study is classified as unacceptable ( MRID 48648501 is currently under review )

.

Table 9 summarize s submitted environmental fate studies for flucarbazone sodium degradates

. Additional data on degradates are not needed since these degradates were determined to be less toxic than the parent compound to aquatic organisms and sufficient

data are available for human drinking water assessment

.

### Page 23 of 39 Table 8 . Submitted Environmental Fate Data for Flucarbazone Sodium

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) 1 Study

Classification Are additional

data needed to

conduct risk

assessment? Justification

835.2120 Hydrolysis 44848851 Acceptable No

-- 835.2240 Aqueous Photolysis 44848902 /

44865802 Acceptable No

--

835.2410 Soil Photolysis 44848901 Supplemental No

--

835.4100 Aerobic

Soil

Metabolism 44848903 Acceptable Yes Guideline

- compliant data are

needed for two additional

soils. 44848904 Acceptable

44848905 Acceptable

835.4300 Aerobic Aquatic

Metabolism 44848906 Unacceptable ND 2 If MRID 48648501 is unacceptable upon review,

then a guideline

- compliant study of two systems will be

needed. 44848907 Unacceptable

44848908 Unacceptable

48648501 (In review)

835.4400 Anaerobic Aquatic

Metabolism 44848909 (In review) No

-- 44848910 Acceptable

44848911 Unacceptable

835.1230 /

835.1240 Adsorption/ Desorption and Leaching 44848912 Acceptable No

-- 44848918 Acceptable

44848919 Acceptable

44848921 (In review)

835.6100 Terrestrial Field Dissipation 44848922/

45083705 Acceptable No

--

44848923/

45083704 Acceptable

44848924/

45083703 Acceptable

44848925 Supplemental

44848926 Supplemental

46223703 Acceptable

46223704 Acceptable

Analytical

Method in Soil 3 44848845 &

44848848 (In review)

46223702 (46926101) Acceptable

Freezer Storage Stability (in soil) 44848920 (In review)

850.6100 Analytical

M ethod in

Water 3 44848850 (46926102) Acceptable No

--

45602401 (46926102) Acceptable No

1 When two MRID numbers are listed and separated by a “/”, this indicates the second MRID is an addendum to the original MRID.

2 ND means “not yet determined; studies are in review.”

### Page 24 of 39 3 MRID in parenthesis reflect an independent laboratory validation (ILV).



### Table 9 . Submitted Environmental Fate Data for Flucarbazone Sodium Degradates

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) 1 Degradate Study

Classification Are additional

data needed to

conduct risk

assessment? Justification

835.2120 Hydrolysis 45823001 O

- desmethyl (In review) No

--

835.4100 Aerobic

Soil

Metabolism 46083801 Sulfonamide (In review) No

--

835.1230

835.1240 Adsorption/ Desorption and Leaching 44848913 Methyltriazoli

none (NMT) Unacceptable No

--

44848914/

45083702 Sulfonamide Acceptable

44848915 Sulfonic Acid Acceptable

44848916/

45083701 Dimethoxytrizo

linone Acceptable

44848917 Sulfonamide; Sulfonic Acid;

O

- desmethyl; Dimethoxytrizo

linone Unacceptable

Analytical

method

in

Soil 44848845/

44848848 Sulfonamide; Sulfonic Acid; Methoxytrizoli

none (NMT) (In review) No

--

44848847 &

44848927 O

- desmethyl (In review)

4622 3702/

46926101 Sulfonamide;

Sulfon ic Acid; Dimethoxytrizo linone (NODT) Acceptable

46223701/

46926103 O

- desmethyl Acceptable No

--

835.7100 Analytical

M ethod

in

Water 2 45602401/ ( 46926102 ) Sulfonamide;

Sulfon ic Acid; Dimethoxytrizo linone (NODT) (In review) No

--

1 When two MRID numbers are listed and separated by a “/”, this indicates the second MRID is an addendum to the original MRID.

2 MRID in parenthesis reflect an independent laboratory validation (ILV).



### 9.2. Effects

Table 10 and Table 11 identify ecological effects studies by MRID that offer data for

each guideline requirement, as well as study classifications and whether or not further data are needed in order to support ris k assessment. Additional data will be required only if one or more of the submitted studies currently undergoing review are classified as unacceptable. These studies are indicated in the tables below.

### Page 25 of 39 Table 10 . Submitted Aquatic Ecological Effects Data for Flucarbazone Sodium

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are additional

data needed to

conduct risk

assessment? Justification

850.1010 Freshwater

invertebrate acute toxicity 4484893 4 Acceptable No

--

850.1025

850.1035 Saltwater

invertebrate acute toxicity 48549303 (I n review) ND 1 A new study is needed if the

studies in review are unacceptable. 48549304 (I n review)

850.1075 Freshwater

fish acute toxicity 44848936 Acceptable No

--

44848937 Acceptable

850.1075 Saltwater fish acute toxicity 48549305 (I n review) ND 1 A new study is needed if the study in review is unacceptable.

850.1300 Freshwater

invertebrate life cycle 4484893 5 Acceptable No

--

850.1350 Saltwater

invertebrates life cycle (None) (N/A) No No acute effects were seen in toxicity studies of f lucarbazone

sodium on freshwater or saltwater aquatic invertebrates.

No chronic effects were seen in a toxicity study on freshwater invertebrates. Therefore,

flucarbazone sodium is not expected to pose a risk to

saltwater invertebrates on a chronic exposure basis.

850.1 400 Freshwater

fish early

- life
stage 4484893 8 Acceptable No

--

### Page 26 of 39 OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are additional

data needed to

conduct risk

assessment? Justification

850.1400 Saltwater fish early

- life

stage (None) (N/A) No No acute effects were seen in toxicity studies of flucarbazone

sodium on freshwater or

saltwater fish. Effects were seen in the early

- life stage study with freshwater fish, however the NOAEC was 1.18 mg ae/L, over three orders of magnitude greater than th e 60

- day EEC calculated in the previous assessment. Therefore,

flucarbazone sodium is not expected to pose a risk to

saltwater fish on a chronic exposure basis at environmentally relevant

concentrations.

850.1500 Fish life cycle (None) (N/A) No

--

850.4400 Aquatic plant growth:

Tier II

vascular plants 44848950 Acceptable No

--

850. 4 5 00 (previously 850.5400) Aquatic Plant

Growth: Tier II algae 44848946 Acceptable No

--

4484894 7 Acceptable

4484894 8 Acceptable

4484894 9 Acceptable

1 ND means “n ot yet determined; studies are in review. ”



### Table 11 . Submitted Terrestrial Ecological Effects Data for Flucarbazone Sodium

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are additional

data needed to

conduct risk

assessment? Justification

850.2100 Avian oral toxicity 44848939 Acceptable N D 1 A new study is needed if the study in review is unacceptable. 48549306 (In review)

850.2200 Avian dietary toxicity 44848941 Acceptable No

--

4484894 3 Acceptable

850.2300 Avian reproduction 44848944 Acceptable No

--

4484894 5 Acceptable

### Page 27 of 39 OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are additional

data needed to

conduct risk

assessment? Justification

Non

guideline Avian

inhalation (None) (N/A) No Inhalation was not identified as a potential exposure pathway of concern by the screening level model STIR.

850.3020 Honey bee

acute contact toxicity 44848933 Acceptable No

--

850.3030 Honey bee

residue on foliage (None) (N/A) No

--

850.3040 Field testing

for pollinators (None) (N/A) No

--

850.4100 Terrestrial plant toxicity:

S eedling

emergence 44848929 Acceptable No

--

850.4150 Terrestrial plant toxicity:

V egetative vigor 44848929 Acceptable No

--

1 ND means “n ot yet determined; studies are in review. ”



### 10. REFERENCES

USEPA. 2000 a . EFED New Chemical Review for Flucarbazone

- Sodium. U.S. Environmental Protection Agency

, Office of Prevention, Pesticides and Toxic Substances, Environmen tal Fate and Effects Division. Sept 13, 2000

.

USEPA. 2000 b . Values to be used in estimating Drinking Water exposure from residues of Flucarbazone sodium (MKH 6562) from use on wheat. U.S. Environmental Protection Agency

, Office of Prevention, Pesticides and Toxic Substances,

Environmental Fate and Effects Divisio n. Memorandum to the Health Effects Division. Aug 14, 2000

.

USEPA. 2004 . Flucarbazone

- Sodium: 24C Request for Aerial Application. DP Barcode

251602. U.S. Environmental Protection Agency

, Office of Prevention, Pesticides and Toxic Substances, Environmental Fate and Effects Division. Memorandum to the Registration Division. July 20, 2004.

USEPA. 2006. Standardized Soil Mobility Classification Guidance. U.S. Environmental Protection Agency

, Office of Prevention, Pesticides and Toxic Substances,

Environmental Fate and Effects Division. Memorandum to the Environmental Fate and Effects Division. April 21, 2006.

### Page 28 of 39 

### USEPA. 2007 a . Ecological Incident Information System. http://www.epa.gov/espp/co nsultation/ecorisk

- overview.pdf

USEPA. 2007 b . ECOTOXicology Database. Office of Research and Development National Health and Environmental Effects Research Laboratory’s (NHEERL’s)

Mid

- Continent Ecology Division (MED). http://cfpub.epa.gov/ecotox/

USEPA. 2009 a

. Ecological Risk Assessment for the Proposed Registration of

Flucarbazone sodium for New Uses on Turf and Conifer Tree Nurseries. U.S. Environmental Protection Agency

, Office of Prevention, Pesticides and To xic Substances, Environmental Fate and Effects Division. Memorandum to the Registration Division. July 22, 2009.

USEPA.2009 b . Tier I Drinking Water Assessment for Flucarbazone

- Na on turf, tree nurseries, and Christmas tree farms. U.S. Environmental Protec tion Agency

, Office of Prevention, Pesticides and Toxic Substances, Environmental Fate and Effects Division. Memorandum to the Registration Division. Mar 24, 2009.

USEPA. 2009 c

. Guidance for Selecting Input Parameters in Modeling the Environmental

Fat e and Transport of Pesticides. Version 2.1. U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Ef fects Division, Oct. 22, 2009. Online at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

USEPA.20 10. Guidance for Making Temperature Adjustments to Metabolism Inputs to EXAMS and PE5. U.S. Environmental Protection Agency, Office of Prevention,

Pesticides and Toxic Substances, Environmental Fate and Effects Division. Memorandum to the Registration Division. October 18, 2010.

USEPA. 2013. Screening Level Usage Analysis. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Biologic al and Economic Analysis Division. May 7, 2013.

Ware, G. W. and D. M. Whitacre. 2004. An Introduction to Herbicides. In The

Pesticide Book

, 6 th 

### ed ; Radcliffe, E. B, Hutchison, W. D. Eds.; MeisterPro Information Resources: Willoughby, OH, 2004. Availa ble at http://ipmworld.umn.edu/chapters/whitacreherb.htm

.

Wood, A. 2007. Compendium of Pesticide Common Names. Available at:

ht tp://www.alanwood.net/pesticides/index.html

.

### Page 29 of 39 MRID Citation Environmental Fate and Product Chemistry Studies

44848845 Peterson, R.; Bethem, R.; Lam, C. et al. (1997) Method Validation for the Analysis of

Soils for MKH 6562 and Three Metabolite Residues: Lab Project Number: 107530:

M2112101: BAYKS01E

- 2. Unpublished study prepared by Alta Analytical Laboratory, Inc. 105 p.

44848847 Morby, R.; McKinney, M.; Lam, C. et al. (1998) Analytical Method for the Determination

of O

- Desmethyl MKH 6562 (Metabolite of MKH 6562) in Soil by High

- Performance Liquid Chromatography Tandem Mass Spectrometry (HPLC/MS/MS): Lab Project

Number: 98B38: 107530

- 2. Unpublished study prepared by Bayer Corp. 43 p.

44848848 Perkins, J.; Anderson, D.; Lowes, S. (1997) Independent Labora tory Validation of Analytical Method for the Determination of MKH 6562 and Three Metabolite Residues in Soil: Lab Project Number: AL6562ILV: 107811: M6112102. Unpublished study prepared by Advance BioAnalytical Services, Inc. and Alta Analytical Laboratory , Inc. 61 p.

44848850 Mattern, G.; Lam, C. (1998) Determination of MKH 6562 in Water by HPLC: Lab Project Number: 108125. Unpublished study prepared by Bayer Corp. 14 p.

44848851 Mattern, G.; Green, D. (1995) Aqueous Hydrolysis of (Phenyl

- U

- (carbon

- 14)) MKH 6562 in Sterile Buffer Solutions: Lab Project Number: 106950: M2072401. Unpublished study prepared by Bayer Corp. 30 p.

44848901 Green, D.; Mattern, G. (1997) Photolysis of (Phenyl

- U

- (carbon

- 14)) MKH 6562 in North Dakota Sandy Loam: Lab Project Number: 107393: M2082101. Unpublished study prepared by Bayer Corporation. 49 p.

44848902 Mattern, G.; Green, D.; Leimkuehler, W. (1996) Aqueous Photolysis of (Phenyl

- U

- (carbon

- 14)) MKH 6562 in Sterile Buffer and Manitoba Pond Water: Lab Project Number:

1 06969: M2082401. Unpublished study prepared by Bayer Corporation. 59 p.

44848903 Pangilinan, N.; Smith, D.; Jackson, S. et al. (1997) Aerobic Metabolism of (Phenyl

- U

- (carbon

- 14)) MKH 6562 in North Dakota Sandy Loam: Lab Project Number: M2042102:

107814. Unpublished study prepared by Bayer Corporation. 64 p.

44848904 Pangilinan, N.; Jackson, S.; Jones, L. et al. (1998) Aerobic Metabolism of (Triazolinone

- 3

- (carbon

- 14)) MKH 6562 in North Dakota Sandy Loam: Lab Project Number: M2042103: 107823. Unpublished study prepared by Bayer Corporation. 72 p.

44848905 Pangilinan, N.; Smith, D.; Jones, L. et al. (1938) Aerobic Metabolism of (Phenyl

- UL

- (carbon

- 14)) MKH 6562 in Manitoba Sandy Loam: Lab Project Number: M2042104: 107815. Unpublished study prepared by Baye r Corporation. 78 p.

44848906 Kelley, I.; McKinney, M.; Bormann, T. (1997) Degradation and Fate of (Phenyl

- UL

- (carbon

- 14)) MKH 6562 in Pond Water: Lab Project Number: M2042402: 107140. Unpublished study prepared by Bayer Corporation. 51 p.

44848907 Parker, G.; Kelley, I. (1998) Aerobic Aquatic Biotransformation of (Phenyl

- UL

- (carbon

14)) MKH 6562: Lab Project Number: M2042405: 107911. Unpublished study prepared by Bayer Corporation. 42 p.

44848908 Kelley, I.; McKinney, M. (1997) Aerobic Aquatic Bio transformation of (Triazolinon

- 3

- (carbon

- 14)) MKH 6562: Lab Project Number: M2042403: 107827. Unpublished study prepared by Bayer Corporation. 43 p.

44848909 Blumhorst, M.; Chopade, H. (1998) Anaerobic Aquatic Metabolism of (Phenyl

- UL

- (carbon

- 14)) MKH 65 62 at 5 (degrees) C: Lab Project Number: M2042406: 122S22: 108313. Unpublished study prepared by EPL Bio

- Analytical Services, Inc. 89 p.

44848910 Halarnkar, P.; Irwin, D. (1997) Anaerobic Aquatic Metabolism of (Phenyl

- UL

- (carbon

14)) MKH 6562: Lab Project Number: M2042401: 107742. Unpublished study prepared by Bayer Corporation. 49 p.

44848912 Blumhorst, M.; Lin, H. (1995) Soil Adsorption/Desorption of MKH 6562: Lab Project Number: M2182101: 122S21: 106976. Unpublished study prepared by EPL Bio

Analytical Services, Inc. 90 p.

### Page 30 of 39 MRID Citation

44848913 Hein, W.; Yen, P. (1998) Adsorption/Desorption of (Carbon

- 14)N

- Methyltriazolinone, an (Carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number: M2182102: BAC10: 108272. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fuer Landwirtschaft, Weinbau und Gartenbau. 41 p.

44848914 Hein, W.; Yen, P. (1998) Adsorption/Desorption of (Carbon

- 14)MKH 6562 Sulfonamide, an (Carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number:

M2182103: B AC07: 108273. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fuer Landwirtschaft, Weinbau und Gartenbau. 55 p.

44848915 Hein, W.; Yen, P. (1998) Adsorption/Desorption of (Carbon

- 14)MKH 6562 Sulfonic Acid, an (Carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number: M2182104: BAC08: 108274. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fuer Landwirtschaft, Weinbau und Gartenbau. 26 p.

44848916 Hein, W.; Yen, P. (1998) Adsorption/Desorption of ( Carbon

- 14)N,O

Dimethyltriazolinone, an (Carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number: M2182105: BAC09: 108275. Unpublished study prepared by Staatliche

Lehr

- und Forschungsanstalt fuer Landwirtschaft, Weinbau und Gartenbau. 55 p.

4 4848917 Blumhorst, M.; Yen, P. (1998) Adsorption/Desorption of (carbon

- 14)MKH 6562 Sulfonamide, (carbon

- 14)MKH Sulfonic Acid, (carbon

- 14)N,O

- Dimethyltriazolinone, (carbon

- 14)

- Methyltriazolinone, and (carbon

- 14)O

- Desmethyl MKH 6562 by Soil from

Richland Cou nty, ND; and (carbon

- 14)Methyltriazolinone by Sand: Lab Project Number: M2182106: 108276: 122S26. Unpublished study prepared by EPL Bio

- Analytical Services, Inc. 109 p.

44848918 Smith, D.; Pangilinan, N. (1998) Leaching of Aged (Phenyl

- UL

- (carbon

- 14))MKH 6562 Residues Through Tiffany Sandy Loam: Lab Project Number: M2092101: 107816. Unpublished study prepared by Bayer Corporation. 61 p.

44848919 Jackson, S.; Pangilinan, N. (1998) Leaching of Aged (Triazolinone

- 3

- (carbon

- 14))MKH 6562 Residues Through Tiffany Sandy Loam: Lab Project Number: M2092102: 108256. Unpublished study prepared by Bayer Corporation. 67 p.

44848920 Billesbach, K. (1998) Freezer Storage Stability of (carbon

- 14)MKH 6562 Sulfonamide,

and (carbon 14)MKH 6562 Sulfonic Acid in Soil: Lab Project Number: M2132101:

108138. Unpublished study prepared by Bayer Corporation. 45 p.

44848921 Mattern, G.; Green, D.; Parker, G. (1995) Outdoor Metabolism and Leaching of (Phenyl

UL

- (carbon

- 14))MKH 6562 in Lysimeters: Lab Project Number: M2042101 : 106931. Unpublished study prepared by Bayer Corporation. 44 p.

44848922 Philpot, J.; Yen, P. (1998) Terrestrial Field Dissipation of MKH 6562 on Bare Loam in Alberta, 1996: Lab Project Number: M2022103: 108133. Unpublished study prepared by Ag

- Quest (ALTA) Inc. and Bayer Corporation. 201 p.

44848923 Philpot, J.; Yen, P. (1998) Terrestrial Field Dissipation of MKH 6562 on Orthic Brown Soil in Outlook, Saskatchewan, 1996: Lab Project Number: M2022104: 108134. Unpublished study prepared by Ag

- Quest (ALT A) Inc., and Bayer Corporation. 194 p.

44848924 Philpot, J.; Yen, P. (1998) Terrestrial Field Dissipation of MKH 6562 on Dark Brown Soil in Saskatoon, Saskatchewan, 1996: Lab Project Number: M2022105: 108135. Unpublished study prepared by Ag

- Quest (ALTA) Inc. and Bayer Corporation. 186 p.

44848925 Harbin, A.; Wood, S. (1998) Terrestrial Field Dissipation of MKH 6562 in Washington Soil, 1996: Lab Project Number: BAYKS01E

- 4: M2022102: 108255. Unpublished study prepared by Qualls Agricultural Laboratory and Alta Analytical Laboratory, Inc. 226 p.

44848926 Harbin, A.; Wood, S. (1998) Terrestrial Field Dissipation of MKH 6562 in North Dakota Soil, 1996: Lab Project Number: AGV96034: BAYKS01E

- 3: M2022101. Unpublished study prepared by Agvise Laboratories Inc. a nd Alta Analytical Laboratory, Inc. 186 p.

44848927 Wiedmann, J. (1999) Independent Laboratory Validation of Bayer Method (Report

Number 107530

- 2) for the Determination of O

- Desmethyl MKH 6562 (Metabolite of MKH 6562) in Soil: Lab Project Number: 7672

- 98

- 0154

- CR

- 001: M2112103: 108810. Unpublished study prepared by Ricerca, Inc. 149 p.

### Page 31 of 39 MRID Citation

44865801 Fontaine, L. (1999) Product Chemistry of MKH 6562 Technical: Lab Project Number: 107273: 108409: 108410. Unpublished study prepared by Bayer Corporation. 102 p.

44865802 Hellpointner, E. (1995) Assessment of the Environmental Half

- life of the Direct Photodegradation of MKH 6562 in Water: Lab Project Number: M143 0710

- 6: 107 \ 123. Unpublished study prepared by Bayer Corporation. 18 p.

45083701 Hein, W. (1999) Adsor ption/Desorption of (carbon

- 14)N,O

- Dimethyltriazolinone, an (carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number: M2182105:

108275

- 1: BAC09. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fur Landwirtschaft, Weinbau, und Gartenbau. 21 p.

45083702 Hein, W. (1999) Adsorption/Desorption of (carbon

- 14)MKH 6562 Sufonamide, an (carbon

- 14)MKH 6562 Metabolite, in Four Soil Types: Lab Project Number: M2182103:

BAC07: 108273

- 1. Unpublished study prepared by Staatliche Lehr

- und Forschungsanstalt fur Landwirtschaft, Weinbau, und Gartenbau. 21 p.

45083703 Mattern, G. (1999) Terrestrial Field Dissipation of MKH 6562 on Dark Brown Soil in Saskatoon, Saskatchewan, 1996

- Report Addendum 1: Lab Project Number: M2022105:

108135: 108135

- 1. Unpublished study prepared by Bayer Corporation. 8 p.

45083704 Mattern, G. (1999) Terrestrial Field Dissipation of MKH 6562 on Orthic Brown Soil in Outlook, Saskatchewan, 1996

- Report Addendum 1: Lab Project Number: M2022104:

108134: 108134

- 1. Unpublished study prepared by Bayer Corporation. 8 p.

45083705 Mattern, G. (1999) Terrestrial Field Dissipation of MKH 6562 on Bare Loam in Alber ta,
1996

- Report Addendum 1: Lab Project Number: M2022103: 108133: 108133

- 1. Unpublished study prepared by Bayer Corporation. 8 p.

4560240 1 Lam, C.; Morby, R.; Leimkuehler, W. (1999) Analytical Method for the Determination of

MKH 6562 and Three Metabolites in Ground Water by High

- Performance Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS): Lab Project Number: 108919. Unpublished study prepared by Bayer Corp. 36 p.

45823001 Aga, D.; Smith, D.; Arthur, E. (2002) Hydrolysis of O

- desmethyl MKH 6562

- t riazolidinine

- 3,5

- (Carbon 14) at pH 3, 5, 7 and 9 in Sterile Aqueous Buffer: Lab Project Number: M2072402: 200145. Unpublished study prepared by Bayer Corporation. 57 p.

46083801 Ripperger, R.; Hall, L. (2003) Aerobic Soil Metabolism of (Carbon 14) MKH 65 62 Sulfonamide. Project Number: 200255, M2042105. Unpublished study prepared by Bayer Corp. 54 p.

46223701 Lam, C.; Qadri, S. (2003) Analytical Method for the Determination of O

- Desmethyl MKH 6562 (Metabolite of MKH 6562) in Soil by High

- Performance Liqui d Chromatography Tandem Mass Spectrometry (LC

- MS/MS). Unpublished study prepared by Bayer Corp. 36

p.
46223702 Lam, C.; Qadri, S. (2003) Analytical Method for the Determination of MKH 6562 and Metabolites NODT, Sulphonic Acid, and Sulphonamide in Soil by High

- Performance Liquid Chromatography Tandem Mass Spectrometry (LC

- MS/MS). Unpublished study prepared by Bayer Corp. 43 p.

46223703 Wood, S. (2004) Terrestrial Field Dissipation of MKH6562 in Washington Soil, 2002. Project Number: M2022107, F02502/0001. Unpublished study prepared by Qualls Agricultural Laboratories, I, Bayer Corp. and A & L Great Lakes Laboratories. 117 p.

46223704 Wood, S.E. (2004) Terrestrial Field Dissipation of MKH6562 in Oklahoma Soil, 2001. Project Number: M2022106, F02500

- 0001. Un published study prepared by South Central Ag Research, Bayer Corp. and A & L Great Lakes Laboratories. 111 p.

46926101 Nelson, S. (2006) Independent Laboratory Validation of Method 200748: "Analytical

Method for the Determination of MKH 6562 and Metabolit es NODT, Sulfonic acid, and Sulfonamide in Soil by High Performance Liquid Chromatography Tandem Mass Spectrometry (LC

- MS/MS): Final Report. Project Number: 05ILV01ARY, 06ARY01/REP, 200748. Unpublished study prepared by ALS Laboratory Group,

Environmental and Bayer Corp. 172 p.

### Page 32 of 39 MRID Citation

46926102 Nelson, S. (2006) Independent Laboratory Validation of Method 108919

- "Analytical Method for the Determination of MKH 6562 and Three Metabolites in Ground Water by High Performance Liquid Chromatography Tandem Mass Spectro metry (LC

- MS/MS)": Final Report. Project Number: 05ILV02ARY, 06ARY02/REP, 108919. Unpublished study prepared by ALS Laboratory Group, Environmental and Bayer Corp. 171 p.

46926103 Nelson, S. (2006) Independent Laboratory Validation of Method 200747

- "Ana lytical

Method for the Determination of O

- Desmethyl MKH 6562 (Metabolite of MKH 6562) in Soil by High Performance Liquid Chromatography Tandem Mass Spectrometry (LCMS/ MS)". Project Number: 05ILV03ARY, 06ARY03/REP, 200747. Unpublished study prepared by ALS Laboratory Group, Environmental and Bayer Corp. 102 p.

48648501 Stenzel, J.I.; E.C. Schaefer (2011) Flucarbazone: Aerobic Aquatic Metabolism. Project Number: 443E/101/OCR. Unpublished study prepared by Wildlife International, Ltd. 103p. Ecological Effects Studies

44848716 Krotlinger, F. (1998) MKH 6562: Study for Acute Oral Toxicity in Rats: Lab Project Number: 23612: T 9055577: 107197. Unpublished study prepared by Bayer AG. 28 p.

44848745 Eiben, R. (1998) MKH 6562: Two

- Generation Study in Wistar

- Rats: Lab Project Number: 27555: T8061038: 108382. Unpublished study prepared by Bayer AG. 976 p.

44848746 Eiben, R. (1998) MKH 6562: Two

- Generation Study in Wistar

- Rats: Supplemental Report: Lab Project Number: 27555 A: T8061038: 108382

- 1. Unpubli shed study prepared by Bayer AG. 29 p.

44848747 Eiben, R. (1998) MKH 6562: Two

- Generation Study in Wistar

- Rats: Supplemental Report: Lab Project Number: 108382

- 2: T8061038: 27555 B. Unpublished study prepared by Bayer AG. 22 p.

44848928 Bowers, L. (1997) Toxicity of MKH 6562 70 WG to Lemna gibba G3 Under Spray Application Conditions: Lab Project Number: M2883702: 107697. Unpublished study prepared by Bayer Corporation. 35 p.

44848929 Hancock, G.; Hansen, C. (1998) Tier 2 Seedling Emergence and Vegetativ e Vigor: Nontarget Phytotoxicity Study Using MKH 6562 70% WG: Lab Project Number: M2201602: 108315. Unpublished study prepared by Bayer Corporation. 97 p.

44848930 Hancock, G.; Hansen, C. (1998) Supplemental Data for Report Number 108315: Tier 2 Seedling Emergence and Vegetative Vigor: Nontarget Phytotoxicity Study Using MKH 6562 70% WG: Lab Project Number: M2201602: 108315

- 1. Unpublished study prepared by Bayer Corporation. 28 p.

44848931 Heimbach , F. (1997) Acute Toxicity of MKH 6562 (tech.) to Earthworms (Eisenia fetida): Lab Project Number: E 310 1220

- 9: 108271: HBF/RG 252. Unpublished study prepared by Bayer AG. 19 p.

44848932 Heimbach, F. (1998) Acute Toxicity of 4

- Methylurazole (a Metabolit e of MKH 6562) to Earthworms (Eisenia fetida): Lab Project Number: E 310 1318

- 7: 108743: HBF/RG 266. Unpublished study prepared by Bayer AG. 21 p.

44848933 Schmitzer, S. (1998) Laboratory Testing for Toxicity (Acute Contact and Oral LD50) of

MKH 6562 tec hn. on Honey Bees (Apis mellifera L.) (Hymnoptera, Apidae): Lab Project Number: 4180036: 108537. Unpublished study prepared by Institute for Biological Analysis and Consulting IBACON GmbH. 30 p.

44848934 Bowers, L. (1996) Acute Toxicity of MKH 6562 to th e Waterflea (Daphnia magna) Under Static Conditions: Lab Project Number: M2820701: 107340. Unpublished study prepared by Bayer Corporation. 29 p.

44848935 Bowers, L. (1996) Chronic Toxicity of MKH 6562 to the Waterflea (Daphnia magna)

Under Static Renewa l Conditions: Lab Project Number: M2840701: 107356. Unpublished study prepared by Bayer Corporation. 52 p.

44848936 Bowers, L. (1995) Acute Toxicity of MKH 6562 Technical to the Rainbow Trout (Ocorhynchus mykiss) Under Static

- Renewal Conditions: Lab Proj ect Number: M2812201: 107143. Unpublished study prepared by Bayer Corporation. 27 p.

### Page 33 of 39 MRID Citation

44848937 Bowers, L. (1995) Acute Toxicity of MKH 6562 Technical to the Bluegill (Lepomis

machrochirus ) Under Static

- Renewal Conditions: Lab Project Number: M2810301: 107136. Unpublished study prepared by Bayer Corporation. 27 p.

44848938 Hall, A. (1998) Early Life Stage Toxicity of MKH 6562 to the Rainbow Trout (Oncorhynchus mykiss) Under Flow

- Through C onditions: Lab Project Number: M2842201: 107838. Unpublished study prepared by Bayer Corporation. 74 p.

44848939 Toll, P. (1995) Technical MKH 6562: An Acute Oral LD50 with Northern Bobwhite (Colinus viginianus): Lab Project Number: M2711701: 107100. Unp ublished study prepared by Bayer Corporation. 25 p.

44848940 Hancock, G. (1997) Technical MKH 6562: A Subacute Dietary LC50 with Northern Bobwhite: Lab Project Number: M2721701: 107359. Unpublished study prepared by Bayer Corporation. 43 p.

44848941 Hancock, G. (1998) Technical MKH 6562: A Subacute Dietary LC50 with Northern Bobwhite: Lab Project Number: M2721702: 108461. Unpublished study prepared by Bayer Corporation. 47 p.

44848942 Hancock, G. (1997) Technical MKH 6562: A Subacute Dietary LC50 wi th Mallard Ducks: Lab Project Number: M2720801: 107102. Unpublished study prepared by Bayer Corporation. 42 p.

44848943 Hancock, G. (1998) Technical MKH 6562: A Subacute Dietary LC50 with Mallards: Lab Project Number: M2720802: 108460. Unpublished study prepared by Bayer Corporation. 46 p.

44848944 Hancock, G. (1998) Effect of Technical MKH 6562 on Mallard Reproduction: L ab Project Number: M2740801: 108491. Unpublished study prepared by Bayer Corporation. 106 p.

44848945 Hancock, G. (1998) Effect of Technical MKH 6562 on Northern Bobwhite Reproduction: Lab Project Number: M2741701: 108492. Unpublished study prepared by B ayer Corporation. 117 p.

44848946 Dobbs, M. (1996) Toxicity of MKH 6562 to Freshwater Green Alga Selenastrum capricornutum: Lab Project Number: M2883501: 107377. Unpublished study prepared by Bayer Corporation. 30 p.

44848947 Bowers, L. (1998) Toxicity of MKH 6562 to the Blue

- Green Alga Anabaena flos

- aquae: Lab Project Number: M2831401: 107836. Unpublished study prepared by Bayer Corporation. 32 p.

44848948 Hall, A. (1998) Toxicity of MKH 6562 to the Freshwater Diatom Navicula pelliculosa: Lab Project Number: M2883401: 107743. Unpublished study prepared by Bayer Corporation. 32 p.

44848949 Bowers, L.; Lam, C. (1998) Toxicity of MKH 6562 Technical to the Marine Diatom Skeletonema costatum: Lab Project Number: M2883601: 108452. Unpublished study prepared by Bayer Corporation. 33 p.

44848950 Bowers, L.; Lam, C. (1998) Toxicity of MKH 6562 Tec hnical to Lemna gibba G3: Lab Project Number: M2883701: 107917. Unpublished study prepared by Bayer Corporation. 34 p.

44848951 Hall, A.; Lam, C. (1999) Toxicity of MKH 6562 Sulfonamide, a Metabolite of MKH 6562, to Lemna gibba G3: Lab Project Number: 96

- B

- 158: 108933. Unpublished study prepared by Bayer Corporation. 28 p.

45694901 Bowers, L. (2000) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using MKH 6562 Sulfonamide (a Metabolite of MKH 6562): Lab Project Number: M245 1301: M2451302: 109475. Unpublished study prepared by Bayer Corporation. 79 p.

46103701a Bowers, L.M. 2005. Tier 1 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using MKH 6562 sulfonamide (a metabolite of MKH 6562) on Lentil,

Oat , and Sugarbeet. Unpublished study performed and sponsored by Bayer CropScience, Stillwell, Kansas, and Research Triangle Park, North Carolina, respectively. Report no.: 200711. Study completed October 9, 2003.

### Page 34 of 39 MRID Citation

46103701b Bowers, L.M. 2005. Tier 1 S eedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using MKH 6562 sulfonamide (a metabolite of MKH 6562) on Lentil, Oat, and Sugarbeet. Unpublished study performed and sponsored by Bayer CropScience, Stillwell, Kansas, and Research Trian gle Park, North Carolina, respectively. Report no.: 200711. Study completed October 9, 2003.

48549303 Minderhout, T.; Krueger, H.; Kendall, T. (2011) Flucarbazone: A 96

- Hour Shell Deposition Test with the Eastern Oyster (Crassostrea virginica). Project Number: 443A/145, 443A/145/OCR. Unpublished study prepared by Wildlife International, Ltd. 58p.

48549304 Minderhout, T.; Kendall, T.; Krueger, H. (2011) Flucarbazone: A 96

- Hour Flow

- through Acute Toxicity Test with the Saltwater Mysid (Americamysi s bahia). Project Number: 443A/143, 443A/143/OCR. Unpublished study prepared by Wildlife International, Inc. 58p.

48549305 Minderhout, T. ; Kendall, T. ; Krueger, H. (2011) Flucarbazone: A 96

- Hour Flow

- through Acute Toxicity Test with the Sheepshead Minno w (Cyprinodon variegatus). Project Number: 443A/144, 443A/144/OCR. Unpublished study prepared by Wildlife International, Ltd. 56p.

48549306 Hubbard, P.; Beavers, J. (2011) Flucarbazone: An Acute Oral Toxicity Study with the Zebra Finch (Poephila guttata). Project Number: 443/132, 443/132/OCR. Unpublished study prepared by Wildlife International, Ltd. 33p.

### Page 35 of 39 

### Appendix A. SIP and STIR Results

SIP

The Scre ening Imbibition Program (SIP version 1.0 ; 6/ 15 / 2010) was used to calculate an upper bound estimate of exposure via drinking water using the solubility of flucarbazone sodium (44,000 mg/L). T he most sensitive acute and chronic avia n toxicity endpoints (bobwhite q uail LD 50 

### >2,000 mg/kg

- bw and mallard du ck NOAEC = 223 mg/kg

- diet

, respectively) and the most sensitive acute and chronic mammalian toxicity endpoints (rat,

LD 50 

### >5,000 mg/kg

- bw and NOAEL = 287 mg/kg

- bw /day, respectively) for flucarbazone

sodium were used

. The non

- definitive acute endpoints res ult in conservative estimates of

LC 50 

### s here. Drinking water exposure to flucarbazone sodium was determined to be a pathway of concern for both avian and mammalian species (LOC exceedances are expected). Results are presented in the tables below

.

SIP Avian R esults for Flucarbazone Sodium

Parameter Acute Chronic
Upper bound exposure (mg/kg

- bw) 35

, 640 35

, 640
Adjusted toxicity value (mg/kg

- bw) 1

, 440 11. 1
Ratio of exposure to toxicity 24.7 322 0

Conclusion* Exposure through drinking

water alone is a potential

concern for birds Exposure through drinking water alone is a potential

concern for birds



### SIP Mammalian R esults for Flucarbazone Sodium

Parameter Acute Chronic
Upper bound exposure (mg/kg

- bw) 7

, 5 70 7,570
Adjusted toxicity value (mg/kg

- bw) 3

, 8 50 22 0
Ratio of exposure to acute toxicity 1.9 7 34. 3

Conclusion* Exposure through drinking water alone is a potential

concern for mammals Exposure through drinking water alone is a potential

concern for mammals

*Conclusion s are 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 potenti al for effects to non

- target animals.



### STIR The Screening Tool for Inhalation Risk (STIR version 1.0; 11/23/2010) was used to calculate upper bound estimates of flucarbazone sodium exposures via inhalation. The exposure pathways assessed include both drop let inhalation and vapor phase inhalation. Model inputs for flucarbazone sodium included molecular weight ( 418.28 g/mole), vapor pressure (<1.00 x10 - 9 

### mmHg ), highest application rate ( 0.025 lb ae /A), most sensitive

acute avia n toxicity endpoint (bobwhite q uail

, LD 50 

### >2,000 mg/kg

- bw ), and most sensitive acute oral and inhalation mammalian toxicity endpoints (rat, LD 50 

### >5,000 mg/kg

- bw and 4 hr inhalation LC 50 

### >5.13 mg/L, respectively). The non

- definitive acute and inhalation endpoints and vapor pressure resu lt in conservative estimates of LC 50 

### s here. Neither droplet nor vapor inhalation were determined to be potential pathways of concern for avian or mammalian species.

### Page 36 of 39 STIR Avian (0.020 kg) Results for Flucarbazone Sodium

Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.25E

- 05

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.83E

- 06

Adjusted Inhalation LD 50 1.14E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.47E

- 07 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.40E

- 03

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 2.10E

- 04 Exposure not Likely Significant



### STIR M ammalian (0.15 kg) Results for Flucarbazone Sodium

Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.25E

- 05

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 3.56E

- 06

Adjusted Inhalation LD 50 3.05E+02

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.16E

- 08 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 3.02E

- 03

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 9.88E

- 06 Exposure not Likely Significant

### Page 37 of 39 

### Appendix B

. ECOSAR Estimates for Flucarbazone Sodium and its Degradates

Chemical Taxa ECOSAR estimate (ppm ai) ECOSAR class

Flucarbazone Sodium (parent)

Log Kow =

- 1.84

Water solubility = 44 g/L FW Fish acute 5190* Ester

FW Fish chronic 800 Daphnid acute 15500* Daphnid chronic 28300*

SW fish acute 9730*

SW fish chronic 755 Mysid acute 51300* Mysid chronic 3.93x10 9 * Green algae acute 960

Earthworm acute 64900*

FW Fish acute 64 Hydrazine

FW Fish chronic 9.7 (ACR) Daphnid acute 660 Daphnid chronic 86 (ACR) Green algae acute 12 Green algae chronic 2.4

FW Fish acute 32500* Amide

FW Fish chronic 7.3 Daphnid acute 1.72x10 5 * Daphnid chronic 1020

SW fish acute 27700* Mysid acute 600 Green algae acute 490 Green algae chronic 110

MKH 6562

Sulfonamide

Log Kow = 1.42 (estimated)

Water solubility = 1.6 g/ L (estimated) FW fish acute 188 Amides

FW fish chronic 0.23 Daphnid acute 271 Daphnid chronic 10

SW fish acute 165 Mysid acute 8.7 Green algae acute 5.2 Green algae chronic 3.8

MKH6562 Sulfonic

Acid

Log Kow =

- 0.118 (estimated)

Water solubility = 33 g/ L (estimated) FW fish acute 1.59x10 5 * Neutral Organics

acid FW fish 14

- day 1.50 x10 5 *

FW fish chronic 12300 Daphnid acute 74400* Daphnid chronic 4200

SW fish acute 1.98 x10 5 *

SW fish chronic 5880 Mysid acute 6.17 x10 5 * Mysid chronic 99900* Green algae acute 51500* Green algae chronic 4170

Earthworm acute 6980

O

- Desmethyl MKH

6562 NMT

Log Kow = 2.83 FW fish acute 1.85 Hydrazines

FW fish chronic 0.080 (ACR) Daphnid acute 6.83 Daphnid chronic 0.396 (ACR) Green algae acute 0.538

### Page 38 of 39 Water solubility = 15 mg/L Green algae chronic 0.183

FW fish acute 16.2* Carbonyl Ureas

FW fish chronic 0.115 Daphnid acute 1.93 Daphnid chronic 0.256

SW fish acute 14.1

SW fish chronic 0.898 Mysid acute 1.19 Green algae acute 0.029 Green algae chronic 0.008

NODT

Log Kow =

- 1.25

Water solubility = 53 g/L FW fish acute 1360 Esters

FW fish chronic 202 Daphnid acute 3990 Daphnid chronic 6930

SW fish acute 2520

SW fish chronic 201 Mysid acute 12200 Mysid chronic 6.71x10 8 * Green algae acute 2840 Green algae chronic 254

Earthworm acute 18700

FW fish acute 87100* Hydrazines

FW fish chronic 5980 Daphnid acute 24900 Daphnid chronic 1550

Green algae acute 22700 Green algae chronic 1060

NMT

Log Kow =

- 0.22

Water solubility = 7.8 g/L FW fish acute 6.90 Hydrazines

FW fish chronic 0.736 (ACR) Daphnid acute 53.5 Daphnid chronic 5.58 (ACR) Green algae acute 1.48 Green algae chronic 0.341

FW fish acute 243 Carbonyl Ureas

FW fish chronic 1.75 Daphnid acute 650 Daphnid chronic 7.45

SW fish acute 212

SW fish chronic 4.68 Mysid acute 4540 Green algae acute 0.009 Green algae chronic 0.002

MKH 6562 Sulfonyl

urea

Log Kow = 0.97

Water solubility = 2.3 g/L FW fish acute 1980 Neutral Organics

FW fish 14

- day 1970

FW fish chronic 173 Daphnid acute 1020 Daphnid chronic 76.4

SW fish acute 2480*

SW fish chronic 143 Mysid acute 3710* Mysid chronic 436 Green algae acute 794 Green algae chronic 109

### Page 39 of 39 Earthworm acute 633
*Estimated toxicity value is greater than the limit of solubility

ACR

– estimate calculated using acute

- to

- chronic ratios