### Page 2 of 71



# Problem Formulation for the
Environmental Fate and Ecological Risk , Endangered Species, and Drinking Water Assessment s in Support
of the R egistration Review of Fenhexamid

N

- (2,3

- dichloro

- 4

- hydroxyphenyl)

- 1

- methylcyclohexanecarboxamide

CAS No. 126833

- 17

- 8
PC Code: 090209

Prepared by: Katrina White, Ph.D., Biologist (Lead Fate Scientist)
Scott Glaberman , Ph.D., Biologist U. S. Environmental Protection Agency Office of Pesticide Programs
Environmental Fate and Effects Division
Environmental Risk Branch IV 1200 Pennsylvania Ave., NW
Mail Code 7507P Washington, DC 20460 

### Reviewed by:
Jim Carleton , Ph.D., Senior Scientist
Thomas Steeger, Ph

. D., Senior Science Advisor
Marietta Ech e verria, Branch Chief

May 1 5 , 2013

### Page 3 of 71



### Contents

1. Introduction

................................ ................................ ................................ ............................ 4
2. Conclusions from Previous Risk Assessments

................................ ................................ ....... 4
2.1. Ecological Risk Assessments

................................ ................................ ....................... 4
2.2. Drinking Water Exposure Assessments

................................ ................................ ....... 6
2.3. Clean Water Act Programs

................................ ................................ .......................... 7 3. Environmental Fate and Transport

................................ ................................ ......................... 7
3.1. Physical

- Chemical Properties, BCF, and Mobility

................................ ...................... 7
3.2. Laboratory Degradation Studies

................................ ................................ .................. 9
3.3. Transformation Products

................................ ................................ ............................ 11
3.4. Field Dissipation

................................ ................................ ................................ ........ 15
3.5. Monitoring Data

................................ ................................ ................................ ......... 16 4. Receptors

................................ ................................ ................................ .............................. 16
4.1. Effects to Aquatic Organisms

................................ ................................ .................... 17
4.2. Effects to Terrestrial Organisms

................................ ................................ ................ 19
4.3. Ecological Incidents

................................ ................................ ................................ ... 21 5. Exposure Pathways of Concern and Risk Hypothesis

................................ .......................... 21 6. Analysis Plan

................................ ................................ ................................ ........................ 22
6.1. Residues of Concern

................................ ................................ ................................ .. 22
6.2. Measures of Exposure

................................ ................................ ................................ 23
6.3. Measures of Effect

................................ ................................ ................................ ..... 23
6.4. Endangered Species Assessments

................................ ................................ .............. 24
6.5. Endocrine Disruptor Screening Program

................................ ................................ ... 24 7. Preliminary Identification of Data Gaps

................................ ................................ .............. 25
7.1. Environmental Fate Data

................................ ................................ ........................... 25
7.2. Effects Data

................................ ................................ ................................ ................ 28
8. Additional Information on Use

................................ ................................ ............................. 37
9. References

................................ ................................ ................................ ............................ 37
9.1. Literature Cited

................................ ................................ ................................ .......... 37
9.2. Studi es Submitted by the Registrant

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

Appendix A. Supplemental Environmental Fate Information

................................ ....................... 46 Appendix B. Screening Level Usage Analysis

................................ ................................ ............. 57 Appendix C. SIP/STIR Model Results

................................ ................................ .......................... 59 Appendix D. Reference List for OPPTS 835 Guidelines and 850 Guidelines Related to Fate

..... 61 Appendix E. AOPWIN V1.92 Output

................................ ................................ ........................... 63 Appendix F. Currently Registered Products Containing Fenhexamid

................................ .......... 64 Appendix G. Summary of exposure pathways, endpoints, and models that will be used in the risk

assessment.

................................ ................................ ................................ ........................ 65 Appendix H. Preliminary Rough Estimate of Exposure Assuming Unextracted Residues are a
Residue of Concern.

................................ ................................ ................................ .......... 66 Appendix I. Toxicity Profile for Fenhexamid.

................................ ................................ ............... 68 Appendix J. Data Call

- In Justification Tables for Non

- guideline Studies

................................ .... 70

### Page 4 of 71



### 1. Introduction

EFED evaluated the most recent ecological risk and drinking water assessments for fenhexamid in association with the updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support R egistration R eview.
Recent risk assessments include a 2007 assessment for the use of fen hexamid on asparagus ( Sut ton and Steeger, 2007, D340419 ) In addition, EFED considered the latest Agency science policies and risk assessment methodologies. The structure, chemical name, and other identifiers
of fenhexamid and its major transformation products can be found in the chemical identity table
attached to this document ( Appendix A )

.

Fenhexamid (CAS No. 126833

- 17

- 8) is an hydroxyanilide fungicide

, and its mode of action is

as a sterol biosynthesis inhibitor in fungi ( Orton et al. , 2011 )

.

Fenhexamid is currently registered for the following agricultural use s : almond s , asparagus, bushberries, caneberries, cherr ies , cucumber s , flavoring and spice crops, forest conifers, fruiting vegetables, ginseng, grapes, kiwi fruit, leafy greens (except spinach) , pear s , pistachio s , pomegranate s , raspberr ies , stone fruits, strawberr ies , and tomato es

. Non

- agricultural uses include ornamental plant s.

The chemical can be applied by chemigation

, airblast, foliar ground spray, and as a dip

treatment. All end

- use products are formulated as water dispersible granule s. There are three
end

- use products. Two products only contain fenhexamid and one contains fenhexamid (14.3%) and captan (53.6%), a phthalamide fungicide

. 1 

### Appendix F summarizes currently registered products containing fenhexamid. The most recen t assessment evaluated use on asparagus at 0.75 lbs a.i./A with two consecutive applications and a minimum retreatment interval of 7 days. Based on the Label Use Information System (LUIS) EFED Table 1 R eport completed on October 30, 2012, the maximum sing le application rate is 0.75 lbs a.i./A, with a maximum seasonal application rate of 3 lbs a.i./A. When the minimum retreatment interval is specified

, it is seven days

. There is some uncertainty with the maximum single application rate for uses on

ornamen tals and forest conifers. The chemical use profile produced by the Biological and Economic Assessment Division (BEAD), located in the docket, lists the maximum single application rate, minimum retreatment interval, and maximum annual or seasonal applicati on

rates for the current uses of fenhexamid. The Screening Level Usage Analysis (SLUA) developed by BEAD is provided in Appendix B . According to the SLUA, most fenhexamid used on agricultural use sites is applied to strawberries and grapes

.

2. Conclusions from Previous Risk Assessments

2.1. Ecological Risk Assessments

Ecological risk assessments completed on fenhexamid on uses are summarized in Table 1

. These risk assessments , along with studies submitted to support the registration of fenhexamid,

1 The TEP containing multiple active ingredients does have agricultural use patterns and may be applied using ground boom equipment. Thus, it may result in spray drift to adjacent water bodies.

### Page 5 of 71



### were used to develop this problem formulation. P otential risks identified in these assessmen ts are briefly summarized in Table 2 and Table 3 below.

Table 1 . Summary of Drinking Water and Ecological Risk Assessments Completed for
Fenhexamid

Use Site (s) Type of
Action Year Drinking Water Ecological

Grapes, strawberries,
ornamentals New
Chemical 1999 ( Cowles, 1999 ) ( Cowle s and Spatz, 1999,
D244921+ ; Cowles and Steeger, 1999, D244921 )

Pears Section 18
CA 1999 ( Cowles and Steeger, 1999,
D257742 ) ( Cowles and Steeger, 1999,
D257742 )
Almon ds,
Stone Fruit Section 3 2000 ( Felthousen, 2000,
D259999 ) ( Felthousen, 2000, D259999 )

Blueberries, Caneberries,
Pistachios Section 3 2002 ( Sutton, 2002, D279884+ ) ( Sutton, 2002, D279884+ )

Kiwi S ection 18
CA 2003 ( Sutton, 2003, D285210+ ) ( Costello, 2003, D293198 )

Kiwifruit,

Lea fy Greens, Fruiting Vegetables, Cucumber Section 3 2003 ( Sutton, 2003, D285210+ ) ( Sutton, 2003, D285210+ )

Pome Fruit Section 3 2004
2006 ( Sutton and Steeger, 2006,

D326293+ ) ( Phillips and Costello, 2004,
D297963 ) ( Sutton and Steeger, 2006,
D326293+ )

Ginseng, Pomegranate,

Non

- bell Pepper, Cilantro Section 3 2005
2006 ( Phillips and Costello, 2004, D297963 ; Sutton and Steeger, 2006, D 326293+ ) ( Phillips and Costello, 2005,
D312268+ ; Sutton and Steeger, 2006, D326289+ )

Asparagus Section 3 2007 ( Sutton, 2007, D338651 ) ( Sutton and Steeger, 2007,
D340419 )



### Fenhexamid was characterized in previous assessments as stable to hydrolysis, though non

persistent in aerobic environments and slightly persistent in anaerobic environments.

F enhexamid has low to moderate mobility in most soils. Fenhexamid’s low persistence in
aerobic environments will limit the amount of the chemical that is able to m igrate into surface and ground water ( Sutton and Steeger, 2007, D340419 )

.

The only Agency levels of concern (LOC) exceeded in previous risk assessments are those for chronic risk to mammals including Federally

- listed threatened and endangered species (hereafter referred to as “listed”) ( Phillips and Costello, 2005, D312268+ ; Sutton and Ste eger, 2006,
D326289+ ) 2 

### . The LOC exceedances were identified for applications ranging from two applications of 0.375 lbs a

. i

. /A (pome fruit; D326293) to four applications of 0.75 lbs a

. i

. /A (ginseng; D312268+). Based on uncertainties regarding potential adverse effects to plants (no terrestrial plant data are available) and on chronic effects to terrestrial organisms, 16

- 23 foot
buffers from naturally vegetated aquatic habitats were previously recommended ( Cowles and Spatz, 1999, D244921+ ; Cowles and Steeger, 1999, D257742 ) ( Sutton, 2002, D279884+ )

.

The following uncertainties were identified in previous risk assessments:

2 Chronic LOCs for mammals were not exceeded in the earliest completed risk assessments but were exceeded in those completed in 2005 and later.

### Page 6 of 71



### Chronic exposure to fenhexamid resulted in decreased neonatal body weights in rats and was
associated with dimin ished feed consumption in birds. Feed consumption rates decreased ( i.e

. , less food consumed with increasing dietary concentration of fenhexamid) in avian
sub acute dietary studies and a chronic avian reproduct ion study. Whether the reduced feed consumptio n was related to palatability or reflected a chemical ly

- induced anorexia is not known; however, the potential to affect feed consumption and neonatal body weights is a

concern. Although none of the LOCs were exceeded for aquatic plants, fenhexamid treatmen t was associated with both chlorosis (loss of color) and necrosis (cell death) in aquatic vascular plants. No terrestrial plant studies were required

, and EFED is not aware of any that have
been submitted. Therefore, there is uncertainty regarding potential effects on terrestrial plants. In preliminary assessments, there was uncertainty in whether solvents used in fate studies increased polymerization of the parent. In 2003 ( Sutton, 2003, D274862 ) d ata were reviewed
that indicated that acetonitrile did not significantly affect either the formation of metabolites or the behavior (including binding) of fenhexamid in soil as compared with the behavior of the compound following application in aqueous solution . Additional data on aerobi c soil
metabolism studies w ere waived. Conditional registrations were made pending additional information on bioconcentration factors and terrestrial field dissipation studies are still outstanding.

Table 2

. P otential risk c oncerns i dentified in previous a ssessments for fenhexamid 1

Birds 2 Mammals Terrestrial

Invertebrates Aquatic

Vertebrates 3 Aquatic

Invertebrates Terrestrial

Plants Aquatic

Plants

Non

- listed

-- C

-- -- -- No data

-- Listed

-- C

-- -- -- No data

-- A = Acute risk; C = Chronic risk;

-- = N o risk

1 Risk concerns were identified when the RQ exceeded the corresponding level of concern in a previous risk

assessment.

2 Birds serve as surrogates for terrestrial

- phase amphibians and reptiles

3 Fish serve as surrogates for aquatic

- phase amphibians



### Table 3

. P otential environmental concerns identified in previous assessments for
fenhexamid

Bioaccumulation 1 Groundwater

Contamination 2 Sediment Persistence Degrades of Concern

Not assessed No Not assessed No None

1 Based on whether previous assessments indicated this was a risk concern or if previous assessments ran

K
ow Based Aquatic Bioaccumulation Model ( KABAM ) for chemicals with a log K
ow greater than three

. 2 Previous risk assessments did not indicate that residues in ground water were high enough to result in a
risk concern.



### 2.2. Drinking Water Exposure Assessments

A drinking water exposure assessment for the use of fenhexa mid on asparagus was conducted in
20 07 ( Sutton and Steeger, 2007 , D340419 )

. Maximum Tier I Estimated Drinking Water Concentrations (EDWC) were developed using the Food Quality Protection Act Index Reservoir Screening Tool (FIRST

, version 1.1.0; dated 12/12/2005) and the regression model Screening

### Page 7 of 71



### Concentration in G round Water (SCI

- GROW, v ersion 3.2, dated 7/29/2003). Exposure estimates
were for fenhexamid (par ent only)

, and were estimated for applications of 0.75 lbs a.i./A applied
with a 7

- day interval and a maximum yearly application rate of 3.0 lbs a.i./A/year. Monitoring data were not summarized in the drinking water assessment.

Table 4

. Maximum EDWC for fenhexamid

Drinking Water Source EDWC (μg/L)
Acute Chronic
Groundwater 0.0007 0.0007
Surface Water 29 1.1



### 2.3. Clean Water Act Programs

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

### No Total Maximum Daily Load s (TMDL) or section 304(a) ambient water quality criteria have been developed for fenhexamid

. 4 

### Aquatic life
benchmarks 5 

### have not been established for fenhexamid . Any data submitted or otherwise located as part of the R egistration R eview process may be used to prepare aquatic life benchmarks if applicable.

3. Environmental Fate a nd Transport

3.1. Physical

- Chemical Properties , BCF, and Mobility

Table 5 summarizes the identity information and physical

- chemical properties of fenhexamid. Fenhexamid, a weak acid, has a log dissociation constant (pK
a 

### ) of 7.3

, and will therefore be
present in both a conjugate base ( anion ic) form 6



### , and in neutral form in the environment. The

water solubility of fenhexamid is a function of the relative amounts of each of these forms as influenced by pH

. I ncreasing pH from 5 to 9 resulted in roughly a 50

- fold in crease in water solubility, i.e ., from 20 to 1000 mg/L. Fenhexamid is considered nonvolatile from dry non

adsorbing surfaces, water, and moist soil. 7 

### The measured log octanol

- water partition coefficient (log K
ow 

### ) decreases with increasing pH and is 3.62, 3.51, and 2.23 at pH 4, 7, and 9 (25 o 

### C), respectively

. E stimated log octanol

- air partition coefficients (log K OA 

### ) range from 12 to 13

. These partition coefficients indicat e that fenhexamid has the potential to biomagnify in terrestrial organisms ( Armitage and Gobas, 2007 ; Gobas et al. , 2003 ; USEPA, 2009c )

, or to bioconcentrate /bioaccumulate in aquatic organisms under some conditions

. However,

3 Specific state causes of impairment that make up the national pesticides cause of impairment group are listed at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.ca use_detail_303d?p_cause_group_id=885

. 4 Specific state pollutants that make up the National Pesticides Pollutant Group and have TMDLs are listed at http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutan t_ group_name=PESTICIDES

. 5 Aquatic Life Benchmarks are available at ( http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm

. 6 Ionizes at the oxygen on the pheny l ring.

7 Based on the volatility classification scheme in Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in the Problem Formulation for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and Other Relevant Risk
Assessments ( U SEPA, 2010b )

.

### Page 8 of 71



### b ioconcentration and biomagnification will likely be lower than predicted based on partition
coefficients alone

, since fenhexamid rapidly degr ades in soil and aquatic environment s , and is
known to be metabolized in vivo as well ( e.g ., conjugated with glucuronic acid)

, based upon
studies on bluegill sun fish ( Lepomis macrochirus ). The maximum measured bioconcentration factor ( BCF ) based on total radioactivity observed in bluegill sunfish tissue was 540 L/kg

- wet weight viscera. Depuration in one BCF study was rapid

, with a half

- life of less than 1 day.
Available BCF values are uncertain

, as they are based on total radioactivity ra ther than on parent compound alone

.

Fenhexamid is classified as moderately mobile to slightly mobile

, with organic

- carbon
normalized Freundlich soil

- water distribution coefficients (K foc 

### ) ranging from 446 to 1

, 226 L/kg

organic carbon measured in six soi ls (MRID 44342722) 8



### . K foc 

### values for WAK 7004, a transformation product of fenhexamid, range from 2,324 to 5,037 L/kg

- organic carbon in four soils (MRID 44346723) and the transformation product is classifi ed a s slightly mobile. Fenhexamid may move into s urface water in water or sediment runoff

. Fenhexamid may be transported into surface water (as indicated by the estimated environmental concentrations

, EECs) and will also partition into sediment.

Table 5

. Summary of physical

- chemical properties of fenhexamid

Parameter Value Source or MRID Comments

PC Code 090209

-- -- CAS Number 126833

- 17

- 8 ( USEPA, 2012 )

--

Molecular Formula C 14 H 17 Cl 2 NO 2 -- --

Chemical Name N

- (2,3

- dichloro

- 4

- hydroxyphenyl)

- 1

- methylcyclohexanecarboxamide -- --

Molecular Weight (g/mole) 302.20

-- --

Water Solubility at 20 o C (mg/L) pH Solubility

44346719

-- 5

- 7 20

8.5 200
9.3 1000

Vapor Pressure o C Vapor Pressure

44346720 Nonvolatile from dry non

adsorbing surfaces Pascal Torr
20 4×10 - 7 3×10 - 9

25 9×10 - 7 7×10 - 9

Henry’s Law constant at 20 o c (atm

- m 3 /mole) pH Henry’s Law Constant

Calculated 1

-- 5

- 7 6×10 - 11

8.5 6×10 - 12

9.3 1×10 - 12
Log Dissociation Constant (pKa) 7.3 44346714 Weak Acid

Octanol

- Water Partition Coefficient (K

ow ) at 20 o C pH log K

ow K
ow

44346717 Has the potential to
bioconcentrate ( USEPA,
2010a ) 4 3.62 4200

7 3.51 3200

9 2.23 170

Air

- water partition coefficient (K AW ) at 20 o C pH Log K AW K AW Calculated 1 Non

- volatile from water 5

- 7

- 9 2×10 - 9

8 Classification is based on the FAO classification system ( USEPA, 2010 a )

### Page 9 of 71 Parameter Value Source or MRID Comments

8.5

- 10 2×10 - 10

9.3

- 10 5×10 - 11

Octanol

- air partition coefficient (K OA ) at 20 o C (unitless) pH Log K OA K OA

Calculated 1 Potential to biomagnify in terrestrial food chains; however, this will likely be mitigated by rapid degradation rates. 2 5

- 7 12 ~2×10 12

8.5 12 7×10 11

9.3 13 3×10 12

C water+soil /C air 1×10 9 to 2×10 11 Calculated 1 Non

- volatile from moist soil

Freundlich Organic

- carbon
normalized soil

- water distribution coefficients (L/kg

- OC) Soil Parent WAK 7004

44346722 for
parent Acceptable. 1/n range from

0.76

- 0.9. Sorption is influenced by pH and %OC Laacher 446

-- Borstel 888

-- Stanley 1024 2324

Howe 1025 2421

Vero 1226 5037

Napa 658 3212 44346723 for
WAK 7004 Supplemental

Bioconcentration Factor for Total Radioactivity

- steady state L/kg

- wet weight 540 viscera 44346747 Supplemental , pH 6.5

- 7.1,
22 o C. Parent made up ~43%
of residues in fish. Values based on total radioactivity.

36.7

- 60.1 edible
248

- 339 viscera
132

- 185 whole fish 44346746 Supplemental, pH 7.1

- 7.5. 20

- 23 o C

1 All estimated values were calculated according to “ Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in Problem Formulations for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and Other Relevant Risk
Assessments ” ( USEPA, 2010a ) . Volatility classifications systems are also provided in the same source.

2 A recent FIFRA Scientific Advis ory Panel (SAP) reported, “Gobas et al (2003) concluded that chemicals with a log K OA >5 can biomagnify in terrestrial food chains if log K OW >2 and the rate of chemical transformation is low. However, further proof is needed before accepting these limits without reservations” ( USEPA, 2009c ) . This was also supported by Armitage and Gobas’s work completed in 2007 ( Armitage and Gobas, 2007 )

.



### 3.2. Laboratory Deg radation Studies

Table 6 summarizes other environmental fate data for the parent

, and provides half

- lives for the

pa rent and unextracted residues. Ch emicals with half

- lives greater than 60 days in soil, water, and sediment are considered persistent ( USEPA, 2008 ) ; therefore, aerobic aquatic and soil
metabolism half

- lives for fenhexamid indicate that it is not persistent. However, there is uncertainty in the half

- lives due to significant amounts of unextracted residues in the metabolism studies. If these unidentified residues were found to be parent, then the compound would be classified as persistent. More discussion on this issue is available in Section 3.3

. Primary routes of degradation are via aerobic soil and aerobic aquatic metabolism. Time for decline in
concentration/mass by 50% (DT 50 

### ) in four aerobic soil s ranged from two hours to a little more
than 24 hours for parent alone and 137 to 1239 days for parent and unextracted residues

. Aerobic soil studies were considered to be supplemental because of the high amounts of

unex tracted residues observed and the uncertainty in whether the carrier solvent increased polymerization of the parent. The uncertainty with the carrier solvent causing polymerization is no longer an uncertainty because studies showed that there was no diffe rence in results from
studies conducted with and without the carrier solvent

. DT 50 

### values in two aerobic aquatic systems ranged from 16 to 17 days for parent and 454 to 734 days for parent and unextracted

### Page 10 of 71



### residues

. Aqueous photolysis may also be an impor tant degradation mechanism when exposure to sunlight is significant

, a s the DT 50 

### for this pathway was a few hours . Fenhexamid is stable to hydrolysis at 25 o 

### C pH 5, 7, and 9

. Soil photolysis was assumed to be minimal in aerobic systems because the percent of applied radioactivity remaining as parent in dark control and irradiated samples was similar over time. The study was considered to be supplemental because the
amount of loss due to soil photolysis alone could not be determined.

Table 6 . Summary of transformation studies conducted on fenhexamid

Study System Details

(Kinetic Equation) Kinetic Equation
Fitted Value 1 Representative

Half

- life to
Derive Model Input (days) 2 Reference Or (MRID ), Study Classification
And Comments DT 50 (days) DT 90

(days)

Abiotic Hydrolysis pH 5, 25 o C
Stable Stable 44346725, Acceptable

pH 7, 25 o C pH 9, 25 o C

Atmospheric Degradation Hydroxyl Radical

( SFO ) 0.61 2.03 Not applicable Estimated using EPIWEB v.4.1 for 12

- hour day

, 1.5x10 6 OH molecules/cm 3

. k=1.13 days - 1 ; See Appendix E

Direct Aqueous Photolysis pH 7, 25 o C

Sterile
40 o N sunlight (SFO) 0.08 0.27 SFO T 1/2 = 0.08 MRID 44346726, Acceptable. Corrected for
40 o N latitude. Phenyl ring labeled.

pH 8, 25 o C
Natural water 40 o N sunlight (SFO) 0.03 0.1 SFO T 1/2 = 0.1 MRID 44346732, Supplemental

- May be used in modeling . Phenyl ring lab e led.

Soil Photolysis sandy loam,

pH 7.1, 25 o C Not significant pathway when

microbial degradation is occurring 44346728, Supplemental. Phenyl ring labeled. Portion of loss due to photolysis versus microbial degradation could not be determined. Up to 47% unextracted residues.

Aerobic Soil
Metabolism (20 o C) IN sandy loam/

Howe pH 7.1

, 1% O C (IORE, SFO*) 0.3

1239* 3.3

4115* T IORE = 1.0

SFO

T 1/2 = 1239*

MRID 44346729, Supplemental

- May be used in

modeling

. Phenyl ring labeled. Some s oils were foreign soils. WRB classifications were not provided, and it was not determined whether soils were representative of a U.S. use
site. Up to 75, 58, 69, and 81% unextracted

residues. German sand/
BBA2.1 pH 5.9, 0.7%OC (IORE, SFO*) 0.091

376* 2.12

1250* T IORE = 0.637
SFO T 1/2 = 376*

German loam sand/
BBA 2.2 pH 6.6, 2.5%OC (IORE, DFOP*) 1.36

449* 11.2

1920* T IORE = 3.4

DFOP slow

DT 50 =634*

German, sandy
loam/ Laacher pH 7.0, 1.4%OC (IORE, DFOP*) 0.378

723* 2.86

2401* T IORE = 0.9

SFO T 1/2 = 723*

IN sandy loam/

Howe pH 7.1

, 1% O C (IORE, DFOP*) 0.125

188* 3.06

823* T IORE = 0.922

DFOP slow

DT 50 =273* MRID 44346730, S upplemental

- May be used in

modeling . Carboxamide ring labeled. No replicates. 1.43 mg/kg soil. WRB cl assifications were not provided , and it was not determined
whether German soil w as representative of a
U.S. use site. Up to 60% unextracted residues. German, sandy
loam/ Laacher pH 7.0, 1.4%OC 0.563

137* 5.00

749* T IORE = 1.51

DFOP slow

DT 50 =263*

### Page 11 of 71

Study System Details

(Kinetic Equation) Kinetic Equation
Fitted Value 1 Representative

Half

- life to
Derive Model Input (days) 2 Reference Or (MRID ), Study Classification
And Comments DT 50 (days) DT 90

(days) (IORE, DFOP*)

Aerobic Aquatic (20 o C) German Lake

pH 5.6

, 3.34% O C (SFO) 15.8

734* 52.6

2439* SFO T 1/2 =

15.8, 734* MRID 44518701

, Acceptable. Phenyl ring

labeled. Up to 75 and 77% unextracted residues. Total system values reported. Multiple unidentified minor degradates. US Lake pH 7

, 3.85% O C (SFO) 17.0

454* 56.5

1508* SFO T 1/2 =

17.0, 454*

Anaerobic Soil (20 o C) IN sandy loam/

Howe: DI water pH 7.1

, 1% O C (SFO) 115

1026* 381

3408* SFO T 1/2 =

115, 1026* 44346731, Accept able. Phenyl ring label ed

. 10

unidentified minor degradates. Mixed with sucralose. Up to 73% unextracted residues. System treated with 300 mg HgCl 2 had 24% unextracted residues. Oxygen content reached

4

- 8% during experiment. WRB=World Resources Base; OC=organic carbon; IN=Indiana; DTX=time for concentration/mass to decline by X
percentage ; SFO=single first order; DFOP=double first order in parallel ; IORE=indeterminate order (IORE); SFO

DT 50 =single first order half

- life; T IORE =the half

- life of a SFO model that passes through a hypothetical DT90 of the IORE fit; DFOP slow DT 50 =slow rate half

- life of the DFOP fit

* Value calculated for parent and unext racted residues which may or may not be parent. These values are relevant in understanding the uncertainty in data due to unextracted residues.

1 DT50 and DT90 values were calculated using nonlinear regression and SFO, DFOP, or IORE equations. The
equat ions can be found in the document, Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half

- life Values and Characterizing Pesticide Degradation ( Bohaty et al., 2012 )

, 2 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 model chosen is consistent with that recommended using the, Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media ( USEPA and Canada, 2011 ) . The same kinetic equ ation used to determine the representative model input value was used to describe the DT50 and DT90 results based on standard kinetic equations.



### 3.3. Transformation Products

Fenhexamid has twenty identified degradates (excluding carbon dioxide ) , three of whi ch are major degradates ( Figure 2 ). The maximum percent of applied radioactivity present as the specified degradate is shown in App endix A . M ost structures are available in Figure 2 , with
additional information in Appendix A

. Many minor degradates were not fully chara cterized and chemical names were only provided for a couple of compounds. Almost all of the identified degradates are similar to the parent (an anilide

, Figure 1 ) except for a few changes in functional groups or the parent base structure present as a dimer or trimer. This includes the three major degradates:

C

- C Biphenyl Dimer, M4, and WAK 7004 (7

- Chloro

- 2

- (1

- methylcyclohexyl)

- 1,3

- benzoxazol

- 6

- ol).

WAK 7004 was the only degradate analyzed for in the terrestrial field dissipation studies

, and it

was found at a maximum of 28 μg/kg

- soil. WAK 7004 was a major degradate in aqueous photolysis studies , where i t appeared as a major degradate in the first 5

- hours and then was undetectable after 24 hours. M4 was also a major degradate observed in the aqueous photolysis
stud ies

, where it increased in amounts up to 26% applied radioactivity (AR) over 24 hours

, and

### Page 12 of 71



### then was detected at 4% AR at the next sampling point

, seven days after application . The C

- C
b iphenyl dimer was a major degradate in the soil photolysis study

, where it reached 14% AR in the first day

, decreased to 5% AR on day 7

, and was 2.4% AR on the last sampling day (18 d).

In the aqu eous photolysis study, degradates M1 and M2 were only characterized as a mixture of up to twelve compounds with the highest amount present as 7% 9 

### . Most of the characterized structures for M1 and M2 were similar to the parent (an anilide) with different fu nctional groups. Succinic acid (CAS No. 110

- 15

- 6, butanedioic acid) was also identified as being present in the mixture. Maximum amounts of the M1 and M2 mixture were increasing at the end of the aqueous photolysis study. A mixture identified as M7 was identified in the anaerobic soil study.
All of the M7s are also anilides

, and are similar to the parent structure.

Figure 1 . Structure of anilide

Formation of unextracted residues was the primary loss mechanism in the soil photolysis, aerobic soil, aerobic aquatic, and anaerobic soil studies (up to 40 to 80% of applied radioactivity). The extraction procedures were similar but slightly different in the various fate studies 10 

### and it is not
clear whether the se extraction procedures were exhaustive. Exhaustive extraction procedures use a range of polar and nonpolar solvents. A high percentage of carbon dioxide did form in the aerobic studies (18 to 40 % of applied radioactivity)

, indicat ing that a significant portion of the parent (at least the portion associated with the phenyl ring) did mineraliz e. However, i n some studies unextracted residues occurred prior to formation of the CO 2 

### , suggesting that the unextracted residues were not mineralizing

, and were not forming with degradation of the parent. Lower percentages of carbon dioxide were observed in the soil photolysis and aerobic aquatic studies (9 to 13% applied radioactivity). Finally, unextract ed residues in some studies peaked in the middle of study and extraction recoveries at the beginning of the study were low (as low as 50%) ; these observations suggest that the extraction procedures were not exhaustive

. Therefore, to account conservatively for the uncertainty in the calculated half

- lives, unextracted residues
will be considered a s potential residues of concern. Additional information on the identity of unextracted residues and on the quality of the extraction procedure would reduce uncerta inties in

9 M1 and M2 were two separate peaks observed using high performance liquid chromatography (HPLC). Structures of compounds making up these two peaks (M1 and M2) were summarized as at least 12 different compounds with four representative structures pr ovided (see page 32 of MRID 44346726).

10 The extraction procedures involved shaking three times in acetone:water:1N HCl (94;5:1) (sometimes in full acetone and water for the second and third extraction). Subsamples were refluxed with boiling in methanol f or six hours. Finally, some samples were subject to pyrophosphate extraction and fractionation. In the terrestrial field dissipation study, soils were soxhlet extracted with methanol:water (80:20 v:v) for eight hours, which yielded 77

- 91% recoveries of t he parent. Solvent solubility studies indicated that fenhexamid was most soluble (>100 g/L) in acetone, polyethylene glycol, dimethylformamide, and dimethylsulfoxide (MRID 44346718). Methanol was not one
of the solvents examined. Not enough information is available to evaluate whether the extractions were exhaustive
extractions.

### Page 13 of 71



### the fate of fenhexamid. Residues of concern for human health drinking water were identified by the Health Effects Division to be the parent only ( Herndon, 1999 )

. This determination may be

re

- visited in Registration Review. Residues of concern for ecological risk were determined by EFED in this probl em formulation, to be the parent

, identified residues that retain the anilide base structure of the parent , and unextracted residues

.

### Page 14 of 71



### Figure 2

. Potential Degradation Pathway for Fenhexamid . Bold degradates had greater than 10% applied radioactivity associated with the compound in at least one submitted fate study. The studies listed under the degradate name indicate the studies that the degradat e was observed in and the maximum amount of the degradate observed in the study.

### Page 15 of 71



### 3.4. Field Dissipation

Four supplemental terrestrial field dissipation studies are available for fenhexamid. These studies only provide supplemental information as many did not monitor major degradates , none of the studies have environmental chemistry methods (ECM) with supporting independent laboratory validation (ILV), n or did they have the replication needed to fully characterize the variability in residues expected in the na tural environment. Standard terrestrial field dissipation studies were completed for two bare ground sites in Canada

, and one study examined a cropped strawberry plot and a bare plot. A lysimeter study was completed in Watsonville, CA. A ll four terrestrial field dissipation studies employed four applications at 0.75 kg a.i. /ha each , with a 5

- 8 day interval between applications

. This is similar to the highest registered use rates for agricultural uses

, which is 0.75 lb a.i./acre with a maximum se asonal rate of 3 lb a.i./acre. When a minimum retreatment interval is provided

, it is 7 days 11 

### . The field dissipation half

- lives ranged from <1 to 3 days

, which is similar to DT 50 

### values observed in aerobic soil laboratory fate
studies. A lysimeter study measured a much slower dissipation half

- life of 44 days. Reasons for the higher DT 50 

### in the lysimeter study are unknown; however, it may be noteworthy that extraction procedures were different than those used in other studies

, and a typical end

- use produ ct was not used in the study.

Table 7

. Summary of Terrestrial Field Dissipation Study Results For Fenhexamid

MRID
(Year) Study Site, Crop DT50 (days) DT90

(days) Max.

Depth Max Conc in Soil

(mg/kg

- soil) Comments

Parent WAK

7004

44580303 (1998 ) Branchon

Ontario, bare soil (strawberries) <1 * NR 15 cm 0.21 NA Supplemental. Less than 5% recovery of field spiked samples. Did not
character ize degradation pathway. No
ILV. P araquat applied to site. Storage stability had 70

- 110% recovery. Low
recoveries observed with method.

44346724
(1996) Watsonville, CA 44 * NR 15 cm 0.762 Supplemental. TEP not used in study. No replicates. Lysimeter study.3.05 lb/A, 4x, interval not reported in DER.
Extracted with acetonitrile: 0.1% acetic acid (8:2) stirring for 1 hour

. 45447501
(2000) British Columbia,

bare 3.19+ 18.9+ 15 cm 3.292 0.0280 Supplemental. Not enough samples to
cha racterize variability on plot , no storage stability information, no ILV

. Only 1 of 3 major degradates followed. 45447501
(2000) Abbotsford,

British Columbia,
strawberries 3.05# 16.5# 15 cm 2.902 0.0206

NA=not analyzed, NR=not reported; ILV=independent laboratory validation; TEP=typical end

- use product *The single first order equation was used t o calculate degradation kinetics. + The DFOP equation was used to calculate degradation kinetics. # The IORE equation was used to calculate degradation kinetics. LOQ for parent=0.01 mg/kg

- soil; LOQ for WAK 7004 =0.005 mg/kg

- soil MRID 44346734(soils not typical of those in U.S.) and 44580302 (time 0 concentrations near detection limit) are unacceptable.

11 Some labels do not include a minimum retreatment interval.

### Page 16 of 71



### 3.5. Monitoring Data

The following databases and sources were searched on February 8, 2012 for monitoring
information on fenhexamid:

The United States Environmental Protection Agency (USEPA) STORET Database ( http://www.epa.gov/storet/dbtop.html ) The United States Geological Sur vey (USGS) National Water

- Quality Assessment (NAWQA) Program Data Warehouse ( http://infotrek.er.usgs.gov/traverse/f?p=NAWQA:HOME:1405517206944567 )
The USGS National Stream Quality Accounting Network (NASQAN) program ( http://water.usgs.gov/nasqan /)

Fenhexamid was looked for in 10 sediment samples ( limit of quantitation ( LOQ ) =3.2 μg/kg) and two surface water samples (LOQ=7.6 ng/L) from three creeks in Georgia located in areas classified as agricultural, urban, and as “ other ” in the NAWQA program

. Concentrations of fenhexamid were below LOQs. It is not known whether fenhexamid use occurred in the areas where these samples were collected.

4. Receptors

The most sensitive endpoi nt for each group of organisms will be used in the risk assessment. Assessment endpoints include direct toxic effects on the survival, reproduction, and growth of terrestrial and aquatic life, as well as indirect effects, such as reduction in prey base and/or
modification of habitat. A summary of the available aquatic and terrestrial toxicity data for fenhexamid and its degradates is provided in Sections 4.1 and 4.2, respectively

. In addition, a summary of ecological incidents associated with fenhexami d is provided in Section 4.3 . Further discussion of potential degradate toxicity is provided in the description of the residues of concern
for fenh examid ( Section 6.1 ).

Acute t oxicity to fish and aquatic invertebrates is categorized using the system shown in Table 8 (USEPA 2004) . Acute t oxicity to terrestrial fauna (birds and mammals) is categorized using the system shown in Table 9 . Acute t oxicity categories for plants have not been define d.

Table 8 . Categories of acute toxicity for aquatic animals

LC 50 ( mg/L ) 1 Toxicity Category

< 0.1 Very highly toxic

> 0.1

- 1 Highly toxic

> 1

- 10 Moderately toxic

> 10

- 100 Slightly toxic

> 100 Practically nontoxic

1 LC 50 median lethal concentration to 50% of the organisms tested.

### Page 17 of 71



### Table 9 . Categories of acute toxicity for terrestrial animals

LD 50 (mg/kg) 1 LC 50 (ppm) Toxicity Category

<10 <50 Very highly toxic

10

- 50 50

- 500 Highly toxic

51

- 500 501

- 1000 Moderately toxic

501

- 2000 1001

- 5000 Slightly toxic

>2000 >5000 Practically nontoxic

1 LD 50 median lethal concentration to 50% of the organisms tested



### 4.1. Effects to Aquatic Organisms

Table 10 contains a summary of the most sensitive fenhexamid toxicity data for aquatic organisms.

Fenhexamid is moderately toxic to rainbow trout ( Oncorhynchus mykiss ; LC 50 

### = 1.34 mg a.i./L ; MRlD 443 46742) and bluegill sunfish (LC 50 

### = 3.42 mg a.i. /L ; MRID 44346741) on an acute exposure basis

. Since freshwater fish serve as surrogates for aquatic

- phase amphibians, the endpoint s for fish apply to aquatic

- phase amphibians as well. Acute toxicity testing using
technical end

- prod uct ( WG

- 50; 49% a.i. ) on rainbow trout yielded rou ghly similar toxicity
estimates ( LC 50 

### = 1.23 mg a.i./L; MRID 44523605). A chronic toxicity study of rainbow trout ( early life

- stage ) produced a no observed adverse effect c oncentration ( NOAEC ) of 0. 10 1 mg a.i./L (MRID 44346745) with the most sensitive endpoint b eing time to swim

- up . Trout fry
treated with as low as 0. 391 mg a.i./L exhibited reduced survival.

Fenhexamid is slightly toxic to the freshwater invertebrate Daphni a magna (EC 50 

### >18.8 mg
a.i. /L; MRID 44366507). In tests using technical end

- product (WG 50; 49.6% a.i. ), fenhexamid was practically non

- toxic to daphnids (EC 50 

### = 105 mg a.i./L ; MR I D 44523604). In a 21

- day
chron ic toxicity test with daphnids, the NOAEC was 1.0 mg a.i./L (MRID 44346744) with growth (l ength) being the most sensitive endpoint.

In estuarine/marine animals, f enhexamid is moderately toxic to sheepshead minnow ( Cyprinodon

vari e gatus ; LC 50 

### = 11 mg a.i./L ; MRD 44346743) and mysid shrimp ( America mysis bahia ; EC 50 

### = 4.6 mg a

. i

. /L; MRID 4346740 ) on an acute exposure basis

. No data were previously required
for chronic toxicity to estuarin e/marine fish or in vertebrates.

### Page 18 of 71



### Toxicity testing with both nonvascular aquatic green algae ( Pseudokirchneriella subcapitata ; EC 50 

### = 4.15 mg a.i./L; MRID 445 18706) and vascular aquatic plants duckweed ( Lemna gibba ; EC 50 

### > 2.3 mg a.i./L; MRID 44731 105) yielded similar estimates of toxicity. The percentage of
duckweed fronds exhibiting necrosis and chlorosis was dependent on the concentration of
fenhexamid. In studies with technical end

- product ( WG

- 50; 49.6% a.i. ), green algae was the most sensitive aquatic plant species (EC 50 

### = 1.37 mg a.i./L; MRlD 445187 10).

Table 10

. Most Sensitive Aq uatic Toxicity Endpoints for Fenhexamid.

Group Species

(Common Name) Study Type

(Measured Effect) Test

Substance (% a.i.) End point

(Test Duration) Toxicity Value

m g a

. i

. /L (Acute Toxicity Category) MRID

( Study
Classification )

Freshwater Fish 1 Oncorhynchus mykiss (Rainbow trout) Acute

(Survival) WG

- 50

(49%) L C 50

(96 hours) 1.23

(moderately toxic) 44523605

(Acceptable)

Chronic: Early
Life

- Stage (Time to swim up) Technical

(95.9%) NOAEC

LOAEC 0.101

0.206 44346745

(Acceptable)

Estuarine/
Marine Fish Cyprinodon

variegatus (Sheepshead minnow) Acute

(Survival) Technical

(≥95%) L C 50

(96 hours) 11*

(slightly toxic) 44346743

(Acceptable)

Freshwater
Invertebrates Daphnia

magna Acute

(Immobilization) Technical

(95.7%) EC 50

(48 hours) >18.8 †

(Slightly toxic to practically

non

- toxic) 44366507

(Supplemental)

Chronic life

cycle (growth [length]; larval survival) Technical

(95.9%) NOAEC

LOAEC 1.0

1.9 44346744

(Acceptable)

Estuarine/
Marine
Invertebrates Americamysis

bahia (Mysid shrimp) Acute

(Survival) Technical

(95.8%) L C 50

(96 hours) 4.6

(moderately toxic) 44346740

(Acceptable)

Vascular Aquatic
Plants Lemna gibba

(duckweed) ( Frond number

,

growth rate, biomass) Technical

(97.7%) EC 50

(14 days) > 2.3 † 44731105 (Acceptable) NOAEC (14 days) 0.28

Non

- Vascular Aquatic Plants Pseudokirchneri

ella subcapitata (green algae) ( Ce ll density) WG

- 50 (49.6%) EC 50

(72 hours) 1.37 44523610 (Supplemental) NOAEC (72 hours) 0.558

EC 50 Effect concentration for 50% of the organisms tested; NOAEC no observed adverse effect concentration

† Non

- definitive study endpoint; cannot be used to calculate RQs for risk estimation.
‡ Freshwater fish may be surrogates for aquatic

- phase amphibians.



### See Appendix I for a full list of available aquatic toxicity endpoints for fenhexamid.

### Page 19 of 71



### 4.2. Effects to Terrestrial Organisms

Table 11 contains a summary of the most sensitive fenhexamid toxicity data for terrestrial organisms.

An avian acute oral toxicity test with bobwhite quail ( Colinus virginianus ; MRID 44346750) resulted in no mortality at either of the two concentrations tested, r esulting in a 14

- day LD 50 

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

- bw. Therefore, fenhexamid is classified as practically non

- toxic to bobwhite quail on an acute oral exposure basis. No mortalities were observed in avian subacute dietary studies conducted with either bobwhite quail or mallard ducks ( Anas platyrhynchos ), resulting in 5

- day LC 50 

### values of >4,962 and >5,469 mg a.i./kg

- diet, respectively (MRIDs 44346751 and 44346752). Therefore, fenhexamid is classified as practically non

- toxic to bobwhite quail and malla rd ducks on a subacute dietary exposure basis. However, feed consumption among bobwhite quail was dependent on the concentration of fenhexamid in the diet. In mallard ducks, there was a decline in average body weights with increasing treatment

concentrat ion groups during both the exposure and post

- exposure periods; in addition, a decrease in body weight was observed in the post

- exposure period (days 6

- 8) in mallard ducks treated with fenhexamid at 2,500 mg a.i./kg

- diet relative to controls.

An avian repr oduction study using bobwhite quail (MRID 44346753) did not result in any chronic growth or reproductive effects at the highest concentration tested (2074 mg a.i./kg

- diet), but feed consumption was significantly (P<0.05) reduced at the 458 and 2,074 mg a.i ./kg

- diet levels, and was dependent on the concentration of fenhexamid in the diet. It is unclear if the
decrease in food consumed was due to food palatability ( repellency ) or to fenhexamid

- induced
anorexia. Since reduced feed consumption was no t associat ed with reduced body weight in treatment groups as compared to the control group, the NOAEC for this study is equal to the highest concentration tested (NOAEC: 2074 mg a.i./kg

- diet)

Since birds serve as surrogates for reptiles and terrestrial

- phase amphib ians, and without data to the contrary, toxicity estimates for birds will apply to these other taxa as well.

Based on acute oral toxicity studies on rats, fenhexamid is categorized as practically non

- toxic to rats ( Rattus norvegicus ; LD 50 

### >5,000 mg/kg

- bw; MRID 44346769). In chronic studies with rats (MRID 44346803), there were no compound

- related effects on mortality, clinical signs, behavior, or reproductive parameters for adult animals; however, clinical chemistry and reduced organ weights resulted in a parental NOAEC and lowest observed adverse effect concentration (LOAEC) of 500 and 5,000 mg/kg

- diet, respectively. The neonatal NOAEC and LOAEC were 5500 and 5,000 mg/kg

- diet, respectively, based on decreased body weights on lactation days 7,
14 and 21 f

or first generation (F 1 

### ) pups (6

- 11 % less than controls) and on lactation days 7, 14, and 21 for second generation (F 2 

### ) pups (9

- 11% less than controls).

Fenhexamid is practically non

- toxic to young adult honeybees ( Apis mellifera ) on acute contact
and or al exposure bases (MRID 44346755). In the acute contact toxicity study, no mortalities occurred at either of the two concentrations tested (100 and 200 μg a

. i

. /bee), resulting in a 48

- hour LD 50 

### of > 200 μg a.i./bee. In the acute oral toxicity study with young adult honeybees, 0

### Page 20 of 71



### and 13% mortality rates were observed at 100 and 201 μg a.i. /bee levels, respectively, resulting
in a 48

- hour LC 50 

### of >201 μg a.i./bee. No sublethal effects were noted.

No a cceptable terrestrial plant toxicity data were identified for fenhexamid.

Table 11 . Terrestrial toxicity profile for fenhexamid.

Group Species Study Type (Effect) Test

Substance
(% a.i.) Endpoint

(Test Duration) Toxicity Value

(Acute Toxicity Category) MRID

(Study Classification)

Birds ‡ Anas

platyrhynchos (mallard duck) Sub

- acute dietary

(Survival) Technical

(95.7%) LC 50

(5 days) >4,962 mg a.i./kg

diet †

(Practically non

toxic) 44346752

(Supplemental)

Colinus virginianus (Northern Bobwhite Quail) Acute oral

(Survival) Technical

(95.7%) LD 50

(14 days) >2,000 mg a.i./kg

bw †

(Practically non

toxic) 44346750

(Supplemental)

Reproductive toxicity (Feed consumption rate) Technical

(95.9%) NOAEC/

LOAEC
(23 weeks) 2,0 74/>2,074

mg a

. i

. /kg

- diet 44346753

(Acceptable)

Mammals Rattus

norvegicus
( Norway rat) Acute oral

(Survival) Technical

(95.5%) LD 50

(Survival) >5,000 mg a.i./kg

bw (Practically non

toxic) 44346769

Rat 2

- generation reproductive toxicity test (decreased body weights) Technical

(93.8

- 95.2%) NOAEC/

LOAEC 500/5,000 mg

a

. i

. /kg

- diet 44346803

Terrestrial
Invertebrates Apis mellifera

(honeybee) Acute Contact

Toxicity
(Survival) Technical

(95.7%) LD 50

(48 hours) >200 μg a.i./bee 44346755 (Acceptable)

Acute Oral Toxicity
(Survival) Technical

(94%) LD 50

(48 hours) >201 μg a.i./bee 44346755 (Supplemental)

Terrestrial
Plants No Toxicity Data Available

LC 50 lethal concentration for 50% of the animals tested; LD 50 lethal dose for 50% of the animals tested; NOAEC no observed adverse effect concentration (mg/kg

- diet); NOAEC no observed adverse effect concentration (mg/kg

- diet)
† Non

- definitive study endpoint; cannot be used to calculate RQs for risk estimation.
‡ Bir ds represent surrogates for terrestrial

- phase amphibians and reptiles.



### See Appendix I for a full list of available terrestrial toxicity endpoints for fenhexamid.

### Page 21 of 71



### 4.3. Ecological Incidents

A review of the Ecological Incident Information System (EIIS) f or incidents involving
fenhexamid was completed on January 31, 2013

. Excluding incidents labeled as either unlikely or unrelated, only one incident ( I013636

- 027 ) was identified in EIIS. This incident involv ed ornamental plants in Washington County, Orego n (IO13636

- 027) where unspecified damage to 6 acres of tulips was associated with a direct application of fenhexamid in 2002. Several other chemicals including isoxaben and glyphosate were included with fenhexamid in a tank mix
around the time of the inci dent. Therefore, the likelihood that fenhexamid caused the incident was classified as “possible.”

A search of OPP’s aggregate incident report database on January 31, 2013 revealed no incidents related to fenhexamid. The Avian Incident Monitoring System of the American Bird Conservancy was also queried on January 31, 2013, and did not list any bird incidents associated
with fenhexamid. 12



### 5. Exposure Pathways of Concern and Risk Hypothesis

The environmental fate properties of fenhexamid and its transformati on products indicate that direct application, spray drift, and runoff are transport mechanisms potentially relevant to ecological exposure. Potential risk to birds and mammals from drinking water exposure to fenhexamid was assessed using the screening pro gram SIP (Screening Imbibition Program)

. When the highest available solubility level of fenhexamid (1000 mg/L; pH 9.3) is used in the program, there are potential drinking water risk concerns to mammals and birds on a chronic exposure basis ( Appendix C )

. Since fenhexamid is classified as practically nontoxic to birds on both an acute oral and subacute dietary exposure basis, and to mammals on an acute oral exposure basis, the likelihood of adverse effects from acute drinking water exposures is
considered l ow. When SIP is run with solubility values at a lower pH (200 mg/L at pH 8.5), there are still potential chronic drinking water exposure risks to mammals but not birds . The inhalation exposure pathway for birds and mammals was screened using the STIR (Scre ening Tool for Inhalation Risk) screening model , ( Appendix C ) , and no potential risk concerns were found

. These screening level models indicated that there was a potential exposure at high enough
concentrations to result in a chronic risk concern for bir ds and mammals due to exposure to fenhexamid residues in drinking water. These models assume exposure occurs at the level of solubility and vapor pressure and are very conservative. SIP and STIR are described in detail at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm

.

Based on previous ecological risk assessments, fenhexamid has the potential to result in chronic
risk to non

- listed and listed terrestrial mammals. Howev er, as the prior ass essments did not include the minor anilide degradates as fenhexamid residues of concern, the following risk hypothesis will be used for this risk assessment:

Based on environmental fate parameters and potential transport pathways, fen hexamid total residues have the potential to reduce survival, reproduction, and/or growth in non

- target terrestrial animals, aquatic vertebrates and invertebrates, and aquatic plants when used in

12 http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfm

### Page 22 of 71



### accordance with the current labels. These non

- target organi sms include listed as well as non

listed species.

Exposure pathways of concern for fenhexamid include spray drift, runoff, residues o n foliage, residues in drinking water, bioconcentration/bioaccumulation, and residues in irrigation water. A
risk assessm ent for sediment dwelling organisms will be performed when the risk assessment is completed. Appendix G summarizes the toxicity endpoints, exposure pathways, and models that will be used in the fenhexamid registration review risk assessment.

6. Analysis P lan

6.1. Residues of Concern

The stressors of ecological concern for aquatic and terrestrial organisms are fenhexamid and degradates that retain the anilide structure similar to the parent

. Residues that retain the anilide

structure include the following: WAK 7004, M4, BBJ98

- 8, M1, M2, M7, ZE056401, M9/KBR 5613, KBR3596, BBJ 98

- 9, BBJ 98

- 11, BBJ 98

- 12, KBR 2931, and KBR 6259. 13 

### M3 and M10 will also be considered residues of concern as their structures are unknown and most degradates
observed are anilides. Additionally, since there is uncertainty in the identity of unextracted residues, they will conservatively be included in the half

- life calculations. Because of their structural similarity to fenhexamid or uncertainty in the structure

, and in the absence of data to the contrary

, anilide degradates and unextracted residues are presumed to have toxicity similar to that of the parent and will therefore be included with fenhexamid as part of t otal t oxic r esidue s (TTR)

. In this approach, a single exposure concentration is estimated for total residues and compared to a representative toxicity endpoint (normally for the parent). To estimate exposure
the amounts of the identified residues in fate studies are added and the s um of residues will be
used to estimate a half

- life that is in turn used in model inputs . S orption coefficient s used for model inputs are chosen from those for parent or a degradate (measured or estimated for degradates using Estimation Program Interface Suite ( EPI Suite 14 

### ) ( USEPA, 2011 ) that is expected to be one of the more mobile residues

. A TTR approach for the above degradates is the default option for risk assessment if suitable toxicity informa tion on these degradates is not
available. However, if suitable degradate toxicity data and environmental fate data are submitted or located through the ECOTOX database ( USEPA, 2009a ) , there is the potential to derive exposure and risk values for these degradates independently.

Residues of concern for human health drinking water were identified by the Health Effects Division to be the parent only ( Herndon, 1999 )

. This determination may be re

- visited in Registration Review.

Determinations on residues of concern may be revisited if new fate or toxicity becomes
available.

13 Current modeling for terrestrial plants doe s not consider environmental fate data. Therefore, a total residue approach does not influence the plant risk assessment. In the model used to estimate exposure to terrestrial animals (TREX), the foliar dissipation rate could be influenced if a total res idue approach is used in the risk assessment; however, if a 35

- day default dissipation rate is used in TREX, fate data do not influence the risk assessment.

14 http://www.epa.gov/opptintr/exposure/pubs/episuite.htm

### Page 23 of 71



### Mixtures

Ev aluation of pesticide environmental mixtures is beyond the scope of this assessment because of myriad factors that cannot be quantified based on the available data. Those factors include identification of other possible co

- contaminants and their concentra tions, differences in the pattern and duration of exposure among contaminants, and the differential effects of other physical/chemical characteristics of the receiving waters ( e.g. organic matter present in sediment and suspended water). Evaluation of fac tors that could influence additivity/synergism is beyond the scope of this assessment and the capabilities of the available data to allow for an evaluation. However, it is acknowledged that not considering mixtures could over

- or under

- estimate risks depe nding on the type of interaction and factors discussed above. The assessment will, however, analyze the toxicity of formulated products (including formulations involving more than one active ingredient) and will determine whether formulated products are m ore toxic than the technical grade active ingredient data used for assessing both direct and indirect risks. One agricultural product contains both fenhexamid and captan ( Appendix F )

. Captan, a phthalamide fungicide, is a non

- specific thiol reactant and inhibits respiration of numerous fungi and bacteria ( USEPA, 20 00 ) and this acts as a fungicide in a different manner than fenhexamid. If use of any of these products result in spray drift to a water body, acute aquatic toxicity data on a representative typical end

- use product should be available for that mixture of ingredients. Additionally, terrestrial plant toxicity data should be available for a typical end

- use product containing the combination of active ingredients.

6.2. Measures of Exposure

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

.

Since the previous exposure assessments were completed, three main changes in st andard procedures were made:

1) Transformation rates for fate studies were recalculated according to the North American Free Trade Agreement (NAFTA) Guidance for Evaluating and Calculating Degradation Kinetics
in Environmental Media ( Bohaty et al. , 2012 ; NAFTA, 2012 )

. These u pdated results will be used in estimating model inputs for estimating aquatic exposure. 2) A new model for estimating concentrations in groundwater was developed called the
Pesticide Root Zone Model

– Groundwater (PRZM

- GW) ( Baris et al. , 2013 )

. This model will be used along with SCI

- GROW to estimate concentrations in ground water. 3) Residues of concern for ecological risk were updated. Estimated environmental
concentrations will reflect exposure to total anilides.

The most up to date procedures and models will be used in the registration review exposure

assessments.

6.3. Measures of Effect

Selected t oxicity data presented in Section 4 of this problem formulation will be used to calculate RQ value s. Any relevant additional information submitted by the registrant or found in the open

### Page 24 of 71



### literature prior to conduct of the risk assessment will also be considered. The open literature
studies are identified using EPA’s ECOTOX icity (ECOTOX) 15 

### database , which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight in to 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 characteristics of the affected
communities.

6.4. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency w ill evaluate risks to listed species from registered uses of pesticides in R egistration

R eview . These assessments will be conducted in accordance with standard EPA procedures and good scientific judgment

. The process for evaluating potential risks to listed species is further
described in the Overview Document at http://www.epa.gov/oppfe ad1/endanger/litstatus/riskasses.htm

.

6.5. Endocrine Disruptor Screening Program

As required by FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals.
Collectiv ely, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its reregistration decision, EPA reviewed these data and selected the most sensitive endpoints for
relevant risk assessment scen arios from the existing hazard database. However, as required by FFDCA section 408(p), fenhexamid is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

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

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

- related effects caused by the substance, and
establish a dose

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

15 http://cfpub.epa.gov/ecotox/

### Page 25 of 71



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

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

- ins, requiring the submission of EDSP screening assays for fenhexamid

. For further
information on the status of t he EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

7. Preliminary Identification of D ata Gaps

7.1. Environmental Fate Data

Table 10 identifies environmental fate studies by MRID that provide data on fenhexamid for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment. Several fate studies are needed to better characterize and reduce significant uncertainties on the environmental fate and transport of fenhexamid

. The re are conditional registrations pending additional data on terrestrial field dissipation and fish
bioconcentration 16



### . The studies listed below will decrease the uncertainty in determining the potential exposure to the pesticide.

Aerobic Soil Metabolism (OPPTS Guideline Number 835.4100 17 

### ) for parent Aerobic Aqu a tic Metabolism (OPPTS Guideline Number 835.4300 18 

### ) for parent Anaerobic Aquatic Metabolism (OPPTS Guideline Number 835.4400 19 

### ) for parent

Terrestrial Field Dissipation Study (OPPTS Guideline Number 835.6 1 00 20 

### ) using a typical end

- use product with corresponding Environmental Chemistry Methods (ECM)
for Soil ( OCSPP Guideline 850. 6 100 21 

### ) for parent and major degradates. The ECM should have an independent laboratory validation (ILV). If valid ECM with ILV and storage stability data are submitted for M RID 45447501 that may be used to fulfill this guideline. If additional terrestrial field dissipation studies are conducted

, anilide degradates should be analyzed

. Environmental Chemistry Methods for Water ( OCSPP Guideline 850. 6 100) for parent and major de gradates Fish Bioconcentration Study (OCSPP Guideline 850.1730 22 

### ) for parent

16 A waiver request for a fish bioconcentration study was submitted by the registrant in 2003. EFED did not concur with the waiver request (Sutton, 2003, D274862).

17 USEPA. 2008. http:/

/www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0152

- 0038

18 USEPA. 2008. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0152

- 0039

19 USEPA. 2008. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0152

- 0039

20 USEPA. 2008. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0152

- 0040

21 USEPA. 2009. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0008

22 USEPA. 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/
Drafts/850

- 1730.pdf

### Page 26 of 71



### Due to the uncertainty in the identity of the unextracted residues as described in Section 3.3
additional data are recommended (aerobic soil, aerobic aquatic metabolism, and anaerobic aquatic metabol i sm) to better understand whether these residues are of concern . EFED
recommends that a range of solvents with different polarities be used in the studies to ensure that the extraction procedures are exhaustive for parent and transformation products. Once
exhaustive extraction procedures are identified in preliminary experiments, studies s hould be completed using the exhaustive extraction procedures. It is recommended that studies be completed with both the phenyl and carboximide rings radiolabeled so that all potential degradates may be followed

. This would reduce uncertainty in the pote ntial that carboxamide degradates are forming that were not followed in fate studies. In lieu of additional data being submitted, EFED will assume that unextracted residues are potential residue s of concern for the
risk assessment . Characterization of u ncertainty will be explored by also calculating risk quotients by assuming that unextracted residues are not residue s of concern.

In addition to the studies recommended for data call in, the registrant is encouraged to submit the following information :

W RB Soil Classifications for Foreign Soils: Many of the fate studies were conducted on foreign soils. Additional information on the World Resource Base (WRB) classifications for studies conducted on foreign soils would reduce uncertainty in determining wh ether the
results apply to soils expected to occur in the United States. Batch Equilibrium Data on Degradates: Often when a TTR approach is used in risk

assessment

, additional data on sorption coefficients for other residues of concern are
recommended. Mo st of the fenhexamid degradates were minor degradates in aerobic soil and aerobic aquatic metabolism studies. Therefore, it was determined that EFED would rely on the available sorption coefficients for WAK 7004 and fenhexamid. EPI Suite may also be
used to estimate a sorption coefficient for some degradates. EFED encourages the registrant to submit any batch equilibrium data that may be available on degradates.

Sensitive ECM: In addition to the ECM and ILV requests above, any other ECMs that the registrant has available may be useful for others to have available for monitoring. Having access to sensitive methods (and standards) using a variety of instruments would enable State Agencies and other interested third parties to investigate incidents or other impacts associated
with fenhexamid use and could provide Agency with a better set of field data than we have a t the present to assess the risk

. These methods could be specific to fenhexamid and/or its transformation products, or multi

- residue methods for multiple compounds that include
fenhexamid and/or its degradates. These methods would add to the methods already available for monitoring.

Table 12

. Submitted environmental fate data for fenhexamid

OCSPP
Guideline Data

Requirement Submitted

Studies (Acc. No. or MRID) Study

Classification Are data

needed to
conduct risk
assessment? Justification and Assumptions EPA will Make in
Absence of Data

835.2120 Hydrolysis 44346725 Acceptable No

835.2240 Aqueous

photolysis 44346726 Acceptable No

44346732 Supplemental No

835.2410 Soil photolysis 44342728 Supplemental No

### Page 27 of 71

OCSPP
Guideline Data

Requirement Submitted

Studies (Acc. No. or MRID) Study

Classification Are data

needed to
conduct risk
assessment? Justification and Assumptions EPA will Make in
Absence of Data

835.4100 Aerobic soil

metabolism 44346729 Supplemental

Yes High lev e ls of unextracted residues were observed in available studies and there is uncertainty in whether the extraction procedures were exhaustive. Therefore, additional data are needed to better understand the uncertainty in the identity of the
unextracted residu es. In lieu of additional data,
EFED will assume that unextracted residues are
residues of concern in the risk assessment. 44346730 Supplemental

835.4200 Anaerobic soil

metabolism 44346731 Acceptable No Data are typically required for four soils. Currently, data are only available on one anaerobic soil system. In lieu of additional data, EFED will characterize anaerobic metabolism based on the study available. While anaerobic soil metabolism data are required according the 40 CFR 158.1300, these data are not typically used in exposure modeling and exposure to humans in ground water is currently not a concern. Therefore, these data would likely have little impact
on the risk conclusions.

835.4300 Aerobic

aquatic
metabolism 44518701 Acceptable Yes High lev e ls of unextracted residues were observed in available studies and there is uncertainty in whether the extraction procedures were exhaustive. Therefore, additional data are needed to better understand the uncertainty in the identity of the
unextracted residu es. In lieu of additional data,
EFED will assume that unextracted residues are
residues of concern in the risk assessment.

835.4400 Anaerobic

aquatic
metabolism No data submitted Yes Data are required for two water/sediments systems.
In lieu of additional data, EFED will assume the anaerobic soil metabolism value is representative of anaerobic aquatic metabolism rates and will apply a
3

- fold uncertainty factor (DT 50 ×3) to estimate a model input value

. Additionally, there were high
levels of unex tracted residues in the anaerobic soil study. In lieu of additional data, EFED will assume
that unextracted residues are residues of concern in
the risk assessment.

835.1230 Adsorption/

desorption 44346722

(Parent) Acceptable

No Data are currently required for the parent on five soils and one sediment. Data are available for parent for
six soils. Additional data are needed to characterize sorptio n of fenhexamid to one sediment . In lieu of additional data, EFED will use availabl e sorption
coefficients to estimate a mean sorption coefficient in modeling

. Additional d ata were not requested as they are not expected to substantially impact the risk
conclusions. 44346732 (WAK 7004) Supplemental

835.6100 Terrestrial

field dissipation 445 8 0303 Supplemental

Yes MRID 45447501 was submitted to fulfill this open data requirement. This study does not have an ILV, storage stability data, and only monitored 1 of 3 major degradates. Additionally, several of the minor 44346724 Supplemental

45447501 Supplemental

44346734 Unacceptable

### Page 28 of 71

OCSPP
Guideline Data

Requirement Submitted

Studies (Acc. No. or MRID) Study

Classification Are data

needed to
conduct risk
assessment? Justification and Assumptions EPA will Make in
Absence of Data

44580302 Unacceptable degradates re tain the anilide structure of the parent and are considered residues of concern. Therefore, additional information on terrestrial field dissipation is still needed. In lieu of additional data, there will be uncertainty in how well the laboratory fate stud ies
reflect what occurs in the field. Submission of an
ILV for the ECM used in MRID 45447501 and storage stability information may eliminate the need for additional information on this uncertainty.

850.6100 Analytical

method in soil 44346734 Not classified

Yes These studies are not standard environmental chemistry method studies . The studies examined degradation in soil and sediment. The environmental chemistry method comp o nents of the studies were reviewed

. Methods are not the same methods used in the terrestrial field dissipation studies ( e.g ., MRID 45447501). Additionally ECMs do not ha ve a corresponding ILV. This is a standard data requirement to support terrestrial field dissipation
studies

. Analytical
method in
sediment 44346731 Not classified

Analytical
method in
freshwater no data submitted An ECM and ILV are needed with a limit of quantitation (LOQ) for the parent below 0.06 mg/L that may be used in monitoring. 1 All major degradates
should be included in the method and have an associated LOQ and limit of detection (LOD) lower
than levels that would result in a risk concern. Additionally, it would be very helpful for the method to be able to measure other anilide degradates. Analytical
method in salt

water 44346738 Not classified No

--

Analytical
method in plant tissue Not

submitted
to U.S. Not reviewed No

--

850.1730 Fish BCF 44346747 Supplemental

Yes Radioactivity was not fully characterized in available studies. Fish BCF studies are still needed to fully understand the potential for bioconcentration of
fenhex a mid. In lieu of additional data, KABAM will
be used to e valuate risk based on measured K

ow and

K
oc . 44346746 Supplemental

ILV=independent laboratory validation; ECM=environmental chemistry method; BCF=bioconcentration factor
1 The LOQ is based on the 96

- hour LC 50 of 1.23 mg a.i./L for the rainbow trout and an LOC of 0.05 (MRID 44523605).



### 7.2. Effects Data

### Page 29 of 71



### Table 13 identifies all available ecological effect s studies for fenhexamid by MRI D , as well as a descri ption of whether further data are needed to support risk assessment

.

Table 13 . Submitted terrestrial and aquatic animal ecological effects d ata for fenhexamid

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

Avian and Mammalian Testing

850.2100 Avian acute oral

toxicity,
waterfowl

— TGAI None N/A No

Avian acute oral toxicity, upland game bird species

— TGAI 44346750 Supplemental No Only two dose levels tested (2000 mg a.i./kg

- bw) , but no mortality occurred at any test level. T here
were some indications of frank sublethal effects to body weight in
birds treated with fenhexamid at 1050 mg a.i./kg

- bw.

Accordin g to the EFED Non

Definitive Endpoint Guidance Policy, additional study data would typically be recommended here because exposure levels were not tested up to 10x the EEC (e.g., peak short grass EEC for birds is 383.47 mg a.i./kg

- bw based on 0.75 lbs
a.i. / A application rate of fenhexamid to ginseng at two applications per seasons with a retreatment interval of 7 days); However, since a passerine acute oral toxicity study (OCSPP 850.2100) is already being recommended, and since passerines
tend to be more sen sitive to fee d consumption/body weight effects than upland game birds , additional
toxici ty testing is not being
recommended at this time.

### Page 30 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

Avian acute oral toxicity, passerine species

— TGAI None N/A Yes Part of 40 CFR Part 158 data requirements as of December 2007; moreover, affects on feed consumption observed in other avian studies may impact passerines to a greater degree given their food intake requirements; in addition, only one avian acute toxicity study is available for fenhexamid, rather
than t he two species indicated in the guidelines (risk to passerine birds
will be assumed in the absence of recommended data)

850.2200 Avian dietary

toxicity

, waterfowl species

— TGAI 44346752 Supplemental No Non

- definitive endpoint of >4,962 mg a.i./kg

- diet is not greater than 10 times the dietary EEC for all uses
and/or food items

Avian dietary toxicity , upland game bird

— TGAI 44346751 Supplemental No Non

- definitive endpoint of >5,469 mg a.i./kg

- diet is not greater than 10 times the dietary EEC for all uses
and/or food items

850.2300 Avian

reproduction

, waterfowl species

— TGAI None N/A No Study previously waived based on
low acute oral and sub

- acute dietary toxicity and lack of reproductive effects in the bobwhite quail chronic toxicity test (MRID 44346753).

850.2300 Avian

reproduction, upland game bird species

— TGAI 44346753 Acceptable No

850.2400 Wild mammal

toxicity

— TGAI None N/A No Not trig gere d based on ecotoxicity data, predicted EECs, fate properties, and use pattern criteria.

850.2500 Simulated or

actual field testing

— TEP None N/A No Not trig gere d based on ecotoxicity data, predicted EECs, fate properties, and use pattern criteria.

Aquatic Animal Testing

850.1010 Freshwater

invertebrate, acute toxicity

— TGAI 44366507 Supplemental No

Freshwater invertebrate, acute toxicity

— TEP 44523604 Supplemental No

### Page 31 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

850.10 2 5 Estuarine/Marine

Mollusk acute toxicity

— TGAI None N/A Yes EFED previously waived this study,

g iven the slight to moderate toxicity
of fenhexamid to aquatic organisms; however, in the two other anilide fungicides (boscalid; metalaxyl) for which Eastern oyster and mysid shrimp acute toxicity data are both available, the oyster was the more sensitive of the two species; in addition, oyster data would provide a firmer basis for informing risk estimates of the many (~123) listed freshwater mollusk species 23

850.1035 Estuarine/Marine

crustacean acute toxicity

— TGAI 44346740 Acceptable No Precipitate observed at highest test level, but centrifugation performed prior to measurements

Estuarine/Marine

crustacean acute toxicity

— TEP (Fenhexamid/ Captan
Co

- formulation; EPA Reg. No.
66330

- 48 ) None N/A Yes Acute toxicity data for this multi

- a.i. product is recommended due to the potential for spray drift and uncertainty concerning how the two chemicals, together, would affect aquatic organisms; estuarine/marine organisms are recommended for testing since they are the most
sensitive to fenhexamid TGAI on an acute exposure basi s.

850.1075 Freshwater fish,

acute toxicity,

warm water species

— TGAI 44346741 Acceptable No

Freshwater fish, acute toxicity,
cold water species

— TGAI 44346742 Acceptable No

Freshwater fish, acute toxicity,
cold water species

— TEP (WG

- 50) 44523605 Acceptable No

23 Number of federally listed mollusks based on the US Fish And Wildl ife Endangered Species Program website: http://www.fws.gov/endangered/species/us

- species.html

### Page 32 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

Estuarine/Marine
fish acute toxicity

— TGAI 44346743 Acceptable No Precipitate at two highest
concentrations

, but centrifugation performed prior to measurements;

mean

- measured concentrations did not appear to have been affected

850.1300 Freshwater

invertebrate, reproduction

test

— TGAI 44346744 Acceptable No

850.1350 Estuarine/marine

invertebrate, reproduction

test

— TGAI None N/A Yes Mysid shrimp (E/M invertebrate) are approximately 20 times more
sensitive than Daphnia magna (FW invertebrate) on an acute exposure basis. Therefore, a chronic E/M invertebrate study is being
recommended to account for this potential sensitivity. In addition,
there is no available fate information to suggest that fenhexamid would
not reach the es tuarine or marine environments. (In the absence of this data, risk to estuarine/marine invertebrates will be assumed; an

acute

- to

- chronic ratio cannot be used to derive a chronic toxicity value for the mysid shrimp since the freshwater acute toxicity value for daphnids is non

- definitive)

850.1400 Freshwater fish

,

early life stage

test

— TGAI 44346745 Acceptable No

Saltwater fish, early life stage

test

— TGAI None N/A No Based on acute toxicity data, E/M fish do not appear to be as sensitive
to fenhexamid as FW fish; therefore, additional data is not expected to change the risk picture.

### Page 33 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

850.1500 Freshwater fish

life cycle test None N/A No Aquatic EECs for some previous uses (e.g., ginseng; 60

- day EEC 0.0136 mg/L) are > 0.1 of the FW fish early life

- stage (ELS) NOAEC (0.1 mg a.i./L); however, since there
were no chronic repro ductive effects
to birds at any fenhexamid concentration tested (MRID 44346753), and since the NOAEL values for pup and adults occurred at the same test level (5000 ppm) in the
rat 2

- generation reproduction study (MRID 44346803), there does not appear to be sufficient rationale for recommending a fish fully life cycle

study.

Estuarine/marine
f ish life cycle test None N/A No

850.1950 Simulated or

actual field testing for aquatic organisms None N/A No Higher tier testing to address risk
uncertainties have not been
identified at this time

Sediment Testing

850.1735 Whole sediment

10

- d freshwater
invertebrate

— TGAI None N/A Yes Data requirement triggered since

some K OC and log K

ow values in
submitted fate studies were above 1,000 and 3.0, respectively (see Appendix J and data justification below table for further details)

850.1740 Whole sediment

10

- d
estuarine/marine
invertebrate

— TGAI None N/A Yes Data requirement triggered since

some K OC and log K

ow values in
submitted fate studies were above 1,000 and 3.0, respectively (see Appendix J and data justification below table for further details)

Agency

wide guideline Whole sediment

chronic
freshwater and/or
marine
invertebrate

— TGAI None N/A Yes Data are recommended pending the
outcome of the 10

- day sediment toxicity studies (850.1735; 850.1740) (see Appendix J and data justification below table for further details)

### Page 34 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

Insect Pollinator Testing

850.3020 Honeybee acute

contact toxicity

— TGAI 44346755 Acceptable No

OECD 213 Honeybee acute

oral toxicity study

— TGAI 44346755 Supplemental Yes Submitted under EPPO Guideline
No. 170 24 ; two

- concentration test; multiple mortalities at higher test level (201 μg/bee or 1, 570 mg/kg); did not test high enough to preclude listed species risk for some uses ( e.g

. , LC 50 of 1,570 is less than 20x the ginseng tall grass EEC of 271

mg/kg )

850.3030 Honeybee

toxicity of
residues on foliage

— TEP None N/A No Data requirement not triggered

850.3040 Field testing for

pollinators None N/A No Field testing to address risk
uncertainties have not been
identified at this time

Non

guideline Larval Toxicity

Test

— TGAI None N/A Yes Recommended since data are only available on the toxicity of fenhexamid to young adult bees; no information is available on toxicity of fenhexamid to honeybee brood. A honeybee larval toxicity test is part of EFEDs current screening process for terrestrial invertebrates.

It is recommended that a protocol be
submitt ed before conducting this

test.

Se e Appendix J for further justification for recommending this

study.

Terrestrial Plant Testing

850. 4100 Seedling

emergence (10 species)

— TEP (representative
fenhexamid single a.i. formulation) None N/A Yes Submitted study should test up to highest currently registered application rate of fenhexamid.

Terrestrial plant toxicity studies with the fenhexamid/captan co

formulated product are being

24 https://secure.fera.defra.gov.uk/beebase/index.cfm?sectionid=64

### Page 35 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

Seedling emergence (10 species)

— TEP (Fenhexamid/ Captan
Co

- formulation; EPA Reg. No.
66330

- 48 ) None N/A Yes recommended since it represents a different typical end

- use product
than formulat ions containing
fenhexamid only . In addition, both compounds are fungicides and may result in increased phytotoxic effects

to non

- target plants.

If terrestrial plant toxicity studies are only submitted for the fenhexamid/captan formulation, then
this data will be used to estimate risk of all fenhexamid formations (both single and multi

- a.i.) to terrestrial plants during risk assessment. If terrestrial plant toxicity studies are only submitted for a single a.i. TEP ( i.e. , fenhexamid only), risk to
terrestri al plants will be assumed for the fenhexamid/captan formulation. 850. 41 50 Vegetative vigor

(10 species)

— TEP (representativ
e fenhexamid single a.i. formulation) None N/A Yes

Vegetative vigor (10 species)

— TEP (Fenhexamid/ Captan
Co

- formulation; EPA Reg. No.
66330

- 48 ) None N/A Yes

Aquatic Plant Testing

850.4400 Aquatic plant

growth, vascular plant

— TGAI 44731105 Acceptable No If uses result in peak EECs that are near or above 2.3 mg/L, then
additional data would be needed. The most recent peak EECs for ginseng were 0.024 mg/L.

850.4500 * Aquatic Plant,

freshwater green alga species

— TGAI 44518706 Supplemental No

44518705 Invalid No Additional data are not needed as there is an existing green algae study (MRID 44518706) that can be used
for risk assessment

Aquatic Plant,
freshwater
diatom

— TEP None N/A Yes Study should test up to highest application rate and/or aquatic EECs

as defined in this problem formulation or previous risk

assessments

Aquatic Plant,
marine diatom

— TEP None N/A Yes Study should test up to highest application rate and/or aquatic EECs as defined in this problem formulation or previous risk

assessments

### Page 36 of 71

Guideline Description

—

Test Substance MRID Study
Classification Are data

Needed for
Risk
Assessment? Comments

( Justification and Assumptions
EPA will Make in Absence of

Data )

850.45 5 0 † Aquatic Plant,

cyanobacterium

— TEP None N/A Yes Study should test up to highest application rate and/or aquatic EECs as defined in this problem formulation or previous risk

assessments TGAI = Technical Grade Active Ingredient
TEP = technical end product

* Algal toxicity tests are now under guideline OCSPP 850.4500 (formerly 850.5400)
† Cyanobacterium tests are now under guideline 850.4550 (formerly 850.5400)



### Request for Sediment Toxicity Studies for Fenhexamid TGAI :

The use pattern, chemical properties, estimated exposure, and toxicity profile of fenhexamid indicate need for chronic (life cycle) sediment toxicity tests to fully evaluate potential risks to benthic invertebrates. These sediment toxicity studies include two freshwater species ( the midge, Chironomus dilutus and the amphipod, Hyalella azteca ) and one saltwater species (the amphipod, Leptocheirus plumulosus ). Multiple species are being recommended in order to account for differential sensitivity and exposure potential of benthic i nvertebrates to fenhexamid. This recommendation is being made because some K OC 

### and log K
ow 

### values in submitted fate
studies were above the thresholds of 1,000 and 3.0, respectively

.

As an alternative to the conduct of three chronic (life cycle) sediment toxicity tests, EFED would also consider a tiered testing approach for sediment toxicity testing. In this approach, sediment toxicity testing would first be conducted with the aforementioned species using the 10

- d (subchronic) sediment toxicity test guide lines (OSCPP 850.1735 25 

### and 850.1740 26 

### ). Then, pending a comparison of estimated environmental concentrations (EEC) in sediment and pore water with toxicity results from the 10

- d sediment toxicity studies, the need for one or more chronic sediment toxicity studies would be determined. This tiered testing approach has the potential advantage of reducing the number of chronic (life cycle) studies that would be needed
when results of the 10

- d (subchronic) tests in conjunction with sediment EECs indicate chroni c testing is not likely to alter risk assessment conclusions. In some cases, however, this tiered testing approach may result in the conduct of both a 10

- d (subchronic) and a chronic (life cycle) study.

If the tiered test approach described above is not preferred, then chronic life

- cycle sediment toxicity studies be carried out on the three preferred species, C. dilutus

, H. azteca , and L. plumulosus

.

25 USEPA. 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/
Drafts/850

- 1735.pdf

26 USEPA. 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/
Drafts/850

- 1740.pdf

### Page 37 of 71



### 8. Additional Informat i on on Use

For risk assessment purposes

, EFED will employ application scenarios that are expected to result in maximum exposure for each given use. Absence of information on the labels regarding maximum single application rates, application intervals, allowable annual maximum rates, or applicat ion methods will result in conservative assumptions as illustrated in the following examples:

If a label does not specify an application interval, an application interval of 3 days will be
assumed.

It would be help f

ul for the registrant to provide suppor ting information on the following label
uncertainties: EPA registration number 66330

- 00035 states that for agricultural uses, applications may be made by ground only. Then in some sections of the label (almonds, pear, pistachios, stone fruit) it provides information for applications by air. EPA intends to engage the registrant to gain additional understanding on this label uncertainty. Maximum single application rates are provided on a crop cycle basis. The maximum number of crop cycles per year for each crop would help to understand the maximum yearly application rate for each crop.

A m aximum single application rate in lbs a.i./A for nursery and ornamentals, forest conifers, and non

- bearing fruit trees and vines is not provided on some labels

.

9. References

9.1. Literature Cited

Armitage, J. M., & Gobas, F. A. P. C. 2007. A terrestrial food

- chain bioaccumulation model for
POPs. Environmental Science and Technology, 41 , 4019

- 4025. Baris, R., Barrett, M., Bohaty, R. F. H., Echeverria, M., Villaneuva, P., Wolf, J., et al. 2013. Guidance for Using PRZM

- GW in Drinking Water Exposure Assessments . December 11, 2012. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Availa ble at http://www.epa.gov/oppefed1/models/water/przm_gw/wqtt_przm_gw_guidance.htm (Accessed January 22, 2013). Bohaty, R. F. H., Eckel, W., White, K., & Young, D. F. 2 012. Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half

- life Values and Characterizing Pesticide Degradation . November 30, 2012. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Available at http://www.epa.gov/oppefed1/ecorisk_ders/degradation_kinetics/NAFTA_Degradation_
Kinetics.htm (Accessed February 8, 2013). Costello, K. 2003.D293198. Section 18 for Fenhexamid to Control Gray Mold (Botrytis cinerea) on Kiwi in California . D293198. September 9, 2003. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency.

### Page 38 of 71



### Cowles, J. 1999. Tier 1 Estimated Environmental Concentrations for Fenhexamid . February 1, 1999. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agenc y. Cowles, J., & Spatz, D. 1999.D244921+. EFED Risk Assessment for Section 3 Registration of Fenhexamid (Elevate TM 50 WDG) . D244921, D244932, D249057, D250286, D253050 & D254139. April 15, 1999. Environmental Fate and Effects Division. Cowles, J., & S teeger, T. 1999.D244921. Fenhexamid Section 3: Strawberries, Grapes, and Ornamentals. Environmental Fate and Ecolgoical Risk Assessment. A Joint Review with
Health Canada . D244921. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Cowles, J., & Steeger, T. 1999.D257742. Section 18 for Fenhexamid to Control Gray Mold (Botrytis cinerea) on pears in California . D257742. July 27, 1999. Environmental Fate
and Effects Division. Office o f Pesticide Programs. United States Environmental Protection Agency. Felthousen, R. W. 2000.D259999. Section 3 Request for the use of Fenhexamid on Almonds and
Stone Fruit . D259999. January 21, 2000. Environmental Fate and Effects Division.
Office of Pesticide Programs. United States Environmental Protection Agency. Gobas, F. A. P. C., Kelly, B. C., & Arnot, J. A. 2003. Quantitative structure activity relationships for predicting the bioaccumulation of POPs in terrestrial food

- webs. QSAR Comb. Sci, 22 , 329

- 336. Herndon, J. G. 1999. Fenhexamid. Results of the HED Metabolism Assessment Review Committee Meeting Held on 03/02/99 . D253792. March 11, 1999. Health Effects Division. Office of Pesticide Programs. United States Environmental Protection Age ncy. NAFTA. 2012. Guidance for Evaluating and Calculating Degradation Kinetics in
Environmental Media . December 2012. NAFTA Technical Working Group on
Pesticides. Available at http://www.epa.gov/oppfead1/international/naftatwg/guidance/degradation

- kin.pdf (Accessed June 12, 2012). Orton, F., Rosivatz, E., Scholze, M., & Kortenkamp, A. 2011. Widely used pesticides with previously unknown endocrine activity reveal ed as in Vitro Antiandrogens. Environmental Health Perspectives, 119 (6), 794

- 800. Phillips, T., & Costello, K. 2004.D297963. Risk Assessment for Proposed Use of Fenhexamid

on Pome Fruit . D297963. May 1, 2004. Environmental Fate and Effects Division.
Off ice of Pesticide Programs. United States Environmental Protection Agency. Phillips, T., & Costello, K. 2005.D312268+. Risk Assessment for Proposed Uses of Fenhexamid on Ginseng, Pomegranate, Non

- Bell Pepper, and Cilantro . D312268, D312269 &
D312270. Ma y 25, 2005. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A. 2002.D279884+. Section 3 Request for the Use of Fenhexamid on Blueberries, Caneberries, and Pistachios . D279 884 & D279885. January 31, 2002. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A. 2003.D274862. Fenhexamid: Response to Waiver Requests for Additional
Aerobic Soil Meta bolism Data and Additional Fish Bioaccumulation Data . D274862.

### Page 39 of 71



### May 27, 2003. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A. 2003.D285210+. Fenhexamid: Tier I Drinkin g Water EEC's for Use in the
Human Health Risk Assessment . D285210, D287861 & D285215. May 13, 2003. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A. 2007.D338651. Drin king Water Assessment for the IR

- 4 Petition for the Use of Fenhexamid on Asparagus . D338651. July 26, 2007. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A., & Steeger, T . 2006.D326289+. Section 3 Registration of Fenhexamid for Use on Ginseng, Pomegranite, Cilantro, and Non

- bell Peppers . D326289 & D326292. February 16, 2006. Environmental Fate and Effects Division. Office of Pesticide Programs.
United States Environmen tal Protection Agency. Sutton, C. A., & Steeger, T. 2006.D326293+. Section 3 Registration of Fenhexamid for Use on Pome Fruit Crop Group . D326293 & D326291. February 16, 2006. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Sutton, C. A., & Steeger, T. 2007.D340419. IR

- 4 Petition for Fenhexamid Use on Asparagus

. D340419. June 14, 2007. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency.
USEPA. 2000. National Pesticide Information Center. Captan Technical Fact Sheet . Oregon State University. U nited States Environmental Protection Agency. Available at http://npic.orst.edu/factsheets/captantech.pdf (Accessed February 13, 2013).
USEPA. 2008. White paper on Methods for Assessing Ecologica l Risks of Pesticides with Persistent, Bioaccumulative, and Toxic Characteristics . In Submitted to the FIFRA Scientific Advisory Panel for Review and Comment (Ed.), October 7, 2008 . Washington,
D.C. Available at http://www.epa.gov/scipoly/SAP/meetings/2008/october/sap_pbt_whitepaper_final_Oct_ 7_08d.pdf (Accessed January 27, 2010).
USEPA. 2009a. ECOTOXicology Database

, United States Environmental Protec tion Agency (USEPA) . Available at http://cfpub.epa.gov/ecotox/ (Accessed June 19, 2009).
USEPA. 2009b. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Versi on 2.1 . Available at http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm (Accessed November 12, 2010).
USEPA. 2009c. SAP Minutes No. 2009

- 01. A set of S cientific Issues Being Considered by the Environmental Protection Agency Regarding: Selected Issues Associated with the Risk Assessment Process for Pesticides with Persistent, Bioaccumulative, and Toxic
Characteristics. October 28

- 31, 2008.

, January 29, 2009 . Available at http://www.epa.gov/scipoly/sap/meetings/2008/102808_mtg.htm (Accessed July 9, 2009).
USEPA. 2010a. Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in the Problem Formulation for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and Other Relevant Risk Assessments

, January 25, 2010

.

### Page 40 of 71



### USEPA. 2010 b. Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in the Problem Formulation for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, an d Other Relevant Risk Assessments . January 25, 2010. Environmental Fate and Effects Division, . Available at http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_s pecies_reregistration_workgroup/esa_reporting_fate.htm (Accessed July 5, 2012). USEPA. 2011. Estimation Program Interface (EPI) Suite: United States Environmental

Pr otection Agency. Available at http://www.epa.gov/oppt/exposure/pubs/episuite.htm (Accessed January 25, 2013). USEPA. 2012. Office of Pesticide Programs Chemical Search. Office of Pesticide Pr ograms. United States Environmental Protection Agency. Available at http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1 (Accessed July 5, 2012). USEPA, & Canada, H. 2011. Guidance for Evaluating and Calculating Degradation Kinetics in
Environmental Media . December 21, 2011. NAFTA Technical Working Group on
Pesticides. Available at http://www.epa.gov/oppfead1/international/naftatwg/guidance/degradation

- kin.pdf (Accessed February 6, 2013). Vonk, J. W. 2000. A steam distillation/extraction method for analysis of soil

- bound residues of
chlorinated anilines and chloroaniline

- containing pesticides. In J. Comejo & P. Jamet (Eds.), Pesticide/soil Interactions (pp. 249

- 254). Paris: Institut National De La Recherche Agronomique.

9.2. Studies Submitted by the Registrant

63

- 8 Solubility
44346718 Krohn , J. (1993) Solubility of KBR 2738 in Representative Organic Solvents:

Lab Project Number: PC 1119: TMN

- 018G: Q 504 0517. Unpublished study prepared by Bayer Ag. 10 p.
44346719 Krohn, J. (1996) Water Solubility of KBR 2738 as a Function of pH: Lab

Projec t Number: PC 1411: TMN

- 018H: 14 660 0896. Unpublished study prepared by Bayer Ag. 14 p.
63

- 9 Vapor Pressure
44346720 Krohn , J. (1995) Vapor Pressure Curve of KBR 2738: Lab Project Number: PC

1064: TMN

- 018J: 14 215 0857. Unpublished study prepared by Bayer Ag. 18 p.
63

- 10 Dissociation Constant
44346714 Stupp , H. (1995) Dissociation Constant and pH of KBR 2738: Lab Project

Number: PC 939: TMN

- 018K: 15 550 202. Unpublished study prepared by Bayer Ag. 11 p.

63

- 11 Oct/Water partition Coef.
44346717 Krohn , J. (1995) Partition Coefficient of KBR 2738 in Octanol

- Water as a

Function of pH: Lab Project Number: PC 1096: TMN

- 018L: 14 447 0884. Unpublished study prepared by Bayer Ag. 14 p.

63

- 13 Stability

### Page 41 of 71



### 44346707 Eberz , A.; Berg, G. (1995) Thermal Stability of the Active Ingredient KBR

2738 (950821ELB04): Lab Project Number: PC 1065: TMN

- 018M: 95/10391. Unpublished study prepared by Bayer Ag. 16 p.
44346708 Lunkenheimer , W. (1997) KBR 2738 Technical: Stability to Metals and Metal

Ions: Lab Project Number: STATEMENT: TMN

- 0018MM. Unpublished study prepared by Bayer Ag. 4 p.
161

- 1 Hydrolysis
44346725 Brumhard, B. (1995) Hydrolysis of KBR 2738 in Sterile Aqueous Buffer

Solutions: Lab Project Number: PF 4098: TMN

- 014H: M 111 0568

- 2. Unpublished study prepared by Bayer Ag. 35 p.
44346761 Reigner, K. (1996) Aqueous Hydrolysis of KBR 2738 Under Conditions of

Processing Studies: Lab Project Number: PF

- 4166: TMN

- 014M: M 177 0800

- 3. Unpublished study prepared by Bayer Ag. 31 p.
161

- 2 Photodegradation

- water
44346726 Brumhard, B.; Bornatsch, W. (1996) Photolysis of KBR 2738 in Aqueous

Solutions: Lab Project Number: 4194: TMN

- 014J: M 112 0569

- 4. Unpublished study prepared by Bayer Ag. 113 p. OPPTS 835.2240.
44346732 Brumhard, B. (1996) Photodegradation of KBR 2738 in Natural Water: Lab

Project Number: PF 4182: TMN

- 0141: M 112 0731

- 5. Unpublished study prepared by Bayer Ag. 56 p.
161

- 3 Photodegradation

- soil
44346728 Brumhard, B. (1996) Photolysis of KBR 2738 on Soil Surfaces: Lab Project

Number: PF

- 4167: TMN

- 014A: M 113 0642

- 7. Unpublished study prepared by Bayer Ag. 67 p.
162

- 1 Aerobic soil metabolism
44346729 Brumhard, B.; Bornatsch, W. (1997) Aerobic Degradation and Metabolism of

KBR 2738 in Soil (Including Amendment): Lab Project Number: PF

- 4195:

TMN

- 014BB: M 125 0550

- 8. Unpublished study prepared by Bayer Ag. 117 p.
44346730 Brumhard, B. (1997) Aerobic Deg radation of (Carboxamide

- (carbon 14))KBR

2738 in Soil: Lab Project Number: PF 4239: TMN

- 014B

- 1: M 999 0844

- 3. Unpublished study prepared by Bayer Ag. 50 p.

162

- 3 Anaerobic aquatic metab.
44346731 Hennebole , J.; Bornatsch, W. (1997) Anaerobic Aquatic (Soil) Metabolism of

KBR 2738: Lab Project Number: PF

- 4203: MR 17/97: TMN

- 014EE. Unpublished study prepared by Bayer Ag. 72 p.

162

- 4 Aerobic aquatic metab.
44518701 Brumhard, B.; Bornatsch, W. (1997) Degradation and Metabolism of KBR 2738

in the System Water/Sediment: Lab Project Number: PF

- 4202: TMN

- 014JJ: M
151 0564

- 2. Unpublished st udy prepared by Bayer Ag. 114.

163

- 1 Leach/adsorp/desorption
44346722 Brumhard, B. (1996) Adsorption/Desorption of KBR 2738 on Different Soils:

Lab Project Number: PF

- 4136: TMN

- 014AA: M 313 0613

- 5. Unpublished study prepared by Bayer Ag. 54 p.

### Page 42 of 71



### 44346723 Fent, G. (1997) Adsorption/Desorption of (Benzoxazol

- 2

- (carbon 14))WAK

7004 on Four Different Soils: (Final Report): Lab Project Number: FM762:

TMN

- 014FF: BAY21. Unpublished study prepared by Staatliche Lehr

- Und Forschungsanstalt fuer Landwirtschaft. 40 p.
164

- 1 Terrestrial field dissipation
44346724 Obrist , J. (1997) Mobility and Degradation of (carbon 14)

- TM

- 402 as

Determined Using Field Lysimeters: Lab Project Number: 96568: TMN

014CCC: 402USATD96.001. Unpublished study prepared by Plant Sciences, Inc. and ABC Laboratories California. 197 p.
44346734 Mo ntonaga, K.; Morishima, N. (1996) Degradation of KBR 2738 in Upland

Soil: Lab Project Number: NR 96050/ESR: TMN

- 014CC: 96032/ESR. Unpublished study prepared by Nihon Bayer Agrochem K. K. 30 p.
44580302 Vaughn, F.; Parnell, J. (1998) Dissipation of TM

- 402 on Bare Soil in Canada

(To Support Registration for Use on Grapes): Lab Project Number: KBR

- SOIL

GRAPE: 97TOM02. Unpublished study prepared by Enviro

- Test Laboratories. 158 p.
44580303 Vaughn, F.; Parn ell, J. (1998) Dissipation of TM

- 402 on Bare Soil in Canada

(To Support Registration for Use on Strawberries): Lab Project Number: KBR

SOIL

- STBRY: 97TOM01. Unpublished study prepared by Enviro

- Test Laboratories. 160 p.
45447501 Vaughn, F. (2000) Dissipat ion of TM

- 402 on Bare Soil and in Strawberry

Culture in Canada: Lab Project Number: 99TOM01: TMN

- 014B

- 4: 1732

- A. Unpublished study prepared by Analytical Development Corporation. 837 p.

165

- 1 Confined rotational crop
44346767 Reiner, H. (1997) Confined Rotational Crop Study with KBR 2738: Lab Project

Number: PF

- 4240: TMN

- 014DD: M 13007146. Unpublished study prepared by Bayer Ag. 113 p.

165

- 4 Bioaccumulation in fish
44346746 Dorgerloh, M. (1996) (Carbon 14)KBR 2738

-- Uptake, Depuration and

Bioconcentration in Bluegill (Lepomis macrochirus) Under Flow

- Through Conditions: Lab Project Number: DOM 95086: TMN

- 001M: E 2440990

- 8. Unpublished study prepared by Bayer Ag. 62 p.
44346747 Printz, H. (1997) (Phenyl

- UL

- (carbon 14))KBR 2738: Identification of

Radioactive Residues in Bluegill Sunfish (Lepomis macrochirus): Lab Project
Number: PF

- 4204: TMN

- 014K: M 289 0788

- 2. Unpublished study prepared by Bayer Ag. 77 p.
9.3.

71

- 1 Avian Single Dose Oral Toxic ity
44346750 Grau, R. (1995) KBR 2738 Technical: Acute Oral Toxicity to Bobwhite

Quail: Lab Project Number: VB

- 038: TMN

- 001Q: E2920907

- 9. Unpublished study prepared by Bayer Ag. 26 p.
71

- 2 Avian Dietary Toxicity
44346751 Grau, R. (1995) KBR 2738 Technical: 5

- Day Dietary LC50 to Bobwhite

Quail: Lab Project Number: VB

- 042: TMN

- 001P: E 295 0875

- 6. Unpublished study prepared by Bayer Ag. 34 p.

### Page 43 of 71



### 44346752 Grau, R. (1995) KBR 2738 Technical: 5

- Day Dietary LC50 to Mallard Duck:

Lab Project Number: VE

- 008: TMN

- 001R: E2970874

- 7. Unpublished study prepared by Bayer Ag. 35 p.
71

- 4 Avian Reproduction
44346753 Schmuck, R. (1997) Effects of a Subchronic Dietary Exposure of KBR 2738

(Technical) on Bobwhite Quail Including Effects on Reproduction and Health (Including Amendment): Lab Project Number: SXR/REP 06: TMN

- 001N: E
293 1027

- 9. Unpublished study prepared by Bayer Ag. 134 p.
72

- 1 Acute Toxicity to Freshwater Fish
44346741 Dorgerloh , M. (1995) KBR 2738 Technical

-- Acute Toxicity (96 Hours) to

Bluegill (Lepomis macrochirus) Under Flow

- Through Conditions: Lab Project Number: DOM 95002: TMN

- 001D: E 252 0916

- 5. Unpublished study prepared by Bayer Ag. 44 p.
44346742 Dorgerloh, M. (1995) KBR 2738 Technical

-- Acute Toxicity (96 Hours) to

Rainbow Trout (Oncorhynchus mykiss) Under Flow

- Through Conditions: Lab Project Number: DOM 95001: TMN

- 001E: E 250 0915

- 2. Unpublished study prepared by Bayer Ag. 46 p.
44523605 Dorgerloh, M. (1996) KBR 273 8 WG 50

-- Acute Toxicity (96 Hours) to

Rainbow Trout (Oncorhynchus mykiss) in a Semi

- Static Test: Lab Project
Number: DOM 95042: TMN

- 001EE: E 281 0995

- 4. Unpublished study prepared by Bayer Ag. 36 p.
72

- 3 Acute Toxicity to Estuarine/Marine Organisms
44346740 Roberts, C.; Swigert, J. (1996) TM

- 402: A 96

- Hour Flow

- Through Acute

Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab Project
Number: 443A

- 101: TMN

- 001A. Unpublished study prepared by Wildlife International Ltd. 68 p.
44346743 Ro berts, C.; Swigert, J. (1996) TM

- 402: A 96

- Hour Flow Through Acute

Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Lab Project Number: 443A

- 102: TMN

- 001B. Unpublished study prepared by Wildlife International Ltd. 68 p.
72

- 4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study
44346744 Heimbach, F. (1996) Influence of KBR 2738 (Tech.) on the Reproduction

Rate of Water Fleas: Lab Project Number: HBF/RDM 56: TMN

- 001I: E 321
1038

- 8. Unpublished study prepared by Bayer Ag. 89 p

. 44346745 Dorgerloh, M. (1996) KBR 2738: Early Life Stage Toxicity to Rainbow Trout

(Oncorhynchus mykiss) Under Flow

- Through Conditions: Lab Project
Number: DOM 96050: TMN

- 001G: E 2841013

- 9. Unpublished study prepared by Bayer Ag. 101 p.
44366507 Heimbach, F. (1995) Acute Toxicity of KBR 2738 (Tech.) to Water Fleas

(Daphnia magna): Lab Project Number: HBF/DM 139: TMN

- 001F: E 320
0913

- 8. Unpublished study prepared by Bayer Ag, Crop Protection. 37 p.
81

- 1 Acute oral toxicity in rats
44345908 Kroetlinger, F. (1995) KBR 2738 50 WG 04258/0214: Study for Acute Oral

Toxicity in Rats: Lab Project Number: 24227: TMN

- 025B: T 4059136. Unpublished study prepared by Bayer Ag Germany. 32 p.

### Page 44 of 71



### 44346769 Bomann , W. (1991) KBR 2738: Study for Acute Oral Toxicity in Rats: Lab

Project Number: 20640: TMN

- 028: T 3037355. Unpublished study prepared by Bayer Ag. 38 p.

81

- 2 Acute dermal toxicity in rabbits or rats
44345909 Kroetlinger, F. (1995) KBR 2738 50 WG 04258/0214: Study for Acute

Dermal Toxicity in Rats: Lab Project Number: 24183: TMN

- 025C: T 5059137. Unpublished study prepared by Bayer Ag Germany. 31 p.
44346770 Bomann, W. (1991) KBR 2738: Study for Acute Dermal Toxicity in Rats:

Lab Project Number: 20 639: TMN

- 026: T 4037356. Unpublished study prepared by Bayer Ag. 37 p.
83

- 4 2

- generation repro.

- rat
44346802 Eigenberg, D.; Hoss , H. (1996) Pilot Study to Establish Dose Levels for a

Two

- Generation Reproduction Study in Rats Using Technical Grade KBR 2738 Administered via the Diet: Lab Project Number: 107460: 8007: TMN

030J. Unpublished study prepared by Bayer Corp. 256 p.
44346803 Eigenberg, D.; Hastings, T. (1997) A Two Generation Dietary Reproduction

Study in Rats Using Technical Grade KBR 2738 (Including Amendment): Lab Project Number: 107461: 8008: TMN

- 030K. Unpublished study prepared by Bayer Corp. 1378 p.
122

- 2 Aquatic plant growth
44518705 Anderson, J. (1996) Influence of KBR 2738 on the Growth of the Green Alga,

Scenedesmus subspicatus: Lab Project Number: AJO/133595: TMN

- 001J: E
323 0948

- 9. Unpublished study prepared by Bayer Ag. 26 p.
44518706 Anderson, J. (1995) Influence of KBR 2738 on the Growth of the Green Alga,

Selenastrum capricornutum: Lab Project Number: AJO/128695: TMN

- 001K:
E3230926

- 5. Unpublished study prepared by Bayer Ag. 41 p.
44523610 Anderson, J. (1995) Influence of KBR 2738 W G 50 on the Growth of the

Green Alga, Selenastrum capricornutum: Lab Project Number: AJO/128795:

TMN

- 001L: E 323 0925 4. Unpublished study prepared by Bayer Ag. 40 p.
44731104 Smith, C. (1998) Fenhexamid Technical: Aquatic Vascular Plant Data

Summary: Lab Project Number: KBR

- 9.8.1

- SUM. Unpublished study prepared by Bayer AG. 5 p.
44731105 Palmer, S.; Krueger, H. (1998) Fenhexamid Technical (TM

- 402): A 14

- Day

Toxicity Test with Duckweed (Lemna gibba G3): Lab Project Number: 443A103. Unpublished study prepared by Wildlife International LTD. 46 p.

123

- 2 Aquatic plant growth
44518705 Anderson, J. (1996) Influence of KBR 2738 on the Growth of the Green Alga,

Scenedesmus subspicatus: Lab Project Number: AJO/133595: TMN

- 001J: E
323 0948

- 9. Unpublished study prepared by Bayer Ag. 26 p.
44518706 Anderson, J. (1995) Influence of KBR 2738 on the Growth of the Green Alga,

Selenastrum capricornutum: Lab Project Number: AJO/128695: TMN

- 001K:
E3230926

- 5. Unpublished study prepared by Bayer Ag. 41 p.
44523610 Anderson, J. (1995) Influence of KBR 2738 W G 50 on the Growth of the

Green Alga, Selenastrum capricornutum: Lab Project Number: AJO/128795:

TMN

- 001L: E 323 0925 4. Unpublished study prepared by Bayer Ag. 40 p.
141

- 1 Honey bee acute contact

### Page 45 of 71



### 44346755 Winkler, R. (1995) Testing Toxicity to Honeybee

-- Apis mellifera L.

(Laboratory) According to EPPO Guideline No. 170: KBR 2738 (Technical): Lab Project Number: 95 10 48 058: TMN

- 017A: 0097201. Unpublished study prepared by Biochem Gmbh Karlsruhe. 23 p.
141

- 2 Honey bee residue on foliage
44346755 Winkler, R. (1995) Testing Toxicity to Honeybee

-- Apis mellifera L.

(Laboratory) According to EPPO Guideline No. 170: KBR 2738 (Technical): Lab Project Number: 95 10 48 058: TMN

- 017A: 0097201. Unpublished s tudy prepared by Biochem Gmbh Karlsruhe. 23 p.
143

- 1 Toxicity to Predator and Parasite Insects
44523608 Mead

- Briggs, M. (1995) A Laboratory Evaluation of the Side

- Effects of the

Fungicide KBR 2738 WG 50 on the Parasitic Wasp Aphidius rhopalosiphi: Lab Project Number: BAY

- 95

- 1: TMN

- 017D. Unpublished study prepared by University of Southampton. 19 p.
870.110 0 Acute oral toxicity
45829702 Mezin, L.; Kuhn, J. (2002) CaptEvate 68 WDG: Acute Oral and Dermal

Toxicity in Rats and Dermal Irritation in Rabbits: Lab Project Number: TMN

0070: 7039

- 02: 7040

- 02. Unpublished study prepared by Stillmeadow, Inc.
and Arvesta Corporation. 43 p.
870.1200 Acute dermal toxicity
45829702 Mezin, L.; Kuhn, J. (2002) CaptEvate 68 WDG: Acute Oral and Dermal

Toxicity in Rats and Dermal Irritation in Rabbits: Lab Project Number: TMN

0070: 7039

- 02: 7040

- 02. Unpublished study prepared by Stillmeadow, Inc. and Arvesta Corporation. 43 p.
870.1300 Acute inhalation toxicity
45829703 Carter, L. (2002) Acute Inhalation Toxicity Study in Rats: Captan 80 WP:

Final Report: Lab Project Number: 7038

- 02. Unpublished study prepared by Stillmeadow, Inc. 27 p.
870.2500 Acute dermal irritation
45829702 Mezin, L.; Kuhn, J. (2002) CaptEvate 68 WDG: Acute Oral and Dermal

Toxicity in Rats and Dermal Irritation in Rabbits: Lab Project Number: TMN

0070: 7039

- 02: 7040

- 02. Unpublished study prepared by Stillmeadow, Inc. and Arvesta Corporation. 43 p.

### Page 46 of 71



### App endix A . Supplemental Environmental Fate Information

Table A1. Structures of Fenhexamid and Its Environmental Transformation Products.
Code Name/ Synonym/
Chemical Name/ Formula/MW/ SMILES Chemical Structure

Fenhexamid, KBR 2738, TM

- 402, KBA 2738 , FEX
IUPAC: 2',3'

- dichloro

- 4'

- hydroxy

- 1

- methylcyclohexanecarboxanilide

CAS: N

- (2,3

- dichloro

- 4

- hydroxyphenyl)

- 1

- methylcyclohexanecarboxamide

CAS No.: 126833

- 17

- 8
Formula: C 14 H 17 Cl 2 NO2
MW: 302.2 g/mole
SMILES: O=C(Nc1ccc(O)c(Cl)c1Cl)C2(C)CCCCC2
WAK 7004, BB J 99

- 3
IUPAC: 7

- Chloro

- 2

- (1

- methylcyclohexyl)

- 1,3

- benzoxazol

- 6

- ol

Formula: C 14 H 16 ClNO
MW: 265.74 g/mol
SMILES: C1=CC(=C(C3=C1N=C(C2(CCCCC2)C)O3)Cl)O[H]

Log K OC =3.9 to 4.9

M1 and M2

SMILES: (a) O=C(NC1=C(C(=C(C(=C1O)O)O)O)O)C2(C)CCCCC2 (b) O=C(NC1=CC=C(C(=C1O)O)O)C2(C)CCCCC2.CO (c) O=C(NC1=C(C(C(=C(C1=O)O)O)=O)O)C2(C)CCCCC2 (d) succinic acid
CAS Number 110

- 15

- 6
SMILES: C(CCC(O)=O)(O)=O 12 compounds not readily separated, see Page 33 of MRID
44434 6726, 4 structures for single components were provided

(a)

(b)

(c)

### Page 47 of 71

Code Name/ Synonym/
Chemical Name/ Formula/MW/ SMILES Chemical Structure

(d)

M4, BBJ98

- 11, Trishydroxyl

- KBR
SMILES: O=C(N(C1=CCC(C=C1)O[H])[H])C2(C)CCCCC2.O.O

C

- C Biphenyl, BBJ98

- 8
SMILES: O=C(N(C1=C(C(=C(C=C1)O[H])Cl)Cl)[H])C 2(C)CCCCC2.O=C(N(C3=C(C(=C(C=C3)O[H])Cl)Cl)[ H])C4(C)CCCCC4.CC

ZE056401, suflonic ester of parent , sulfonic ester Fex
SMILES: O=C(NC1=C(C(=C(C=C1)O[S](O)(O)O)Cl)Cl)C2(C)CC
CCC2

M7

- B
N

- acetyl

- 2,3

- dichloro

- p

- aminophenol (proposed)

SMILES: O=C(N(C1=C(C(=C(C=C1)O[H])Cl)Cl)[H])C

### Page 48 of 71

Code Name/ Synonym/
Chemical Name/ Formula/MW/ SMILES Chemical Structure

Ketoisomers (proposed), M7

- C, M7

- F, M7

- H

- M7

- K

SMILES: O=C(N(C1=C(C(=C(C=C1)O[H])Cl)Cl)[H])C2(C)CCCC
C2.=O

KBR 7133, M7

- I, OH

- KBR

SMILES: O=C(N(C1=C(C(=C(C= C1)O[H])Cl)Cl)[H])C2(C)C(CC CC2)O[H]

KBR7115, M7

- G, OH

- KBR
SMILES: O=C(N(C1=C(C(=C(C=C1)O[H])Cl)Cl)[H])C2(C)CC(C CC2)O

KBR6720, KBR6798, M7

- E
OH

- KBR
SMILES: O=C(N(C1=C(C(=C(C=C1)O[H])Cl)Cl)[H])C2(C)CCC( CC2)O

BNF 5537C
MW: 178.02 g/mol e SMILES: C1=CC(=C(C(=C1N)Cl)Cl)O Log K OW =1.53 Water Solubility=2813.6 mg/L

K OC =246.7 (MCI method) and 82.53 (K OW method)
KBR 2931, WAK 6919
MW: g/mol
SMILES: C1=C(C(=CC=C1N(C(C2(CCCCC2)C)=O)[H])O[H])Cl

CH3

- phenyl FEX, KBR 3596, BBJ 98

- 7
SMILES: C1(=C(C(=CC=C1N(C(C2(CCCCC2)C)=O)[H])OC)Cl)
Cl

### Page 49 of 71

Code Name/ Synonym/
Chemical Name/ Formula/MW/ SMILES Chemical Structure

KBR3954
SMILES: C1(=C(C(=CC=C1N(C(C2(CCCCC2)C)=O)[H])O)Cl)Cl

KBR5613, WAK6920, M9
SMILES: C1(=CC(=CC=C1N(C(C2(CCCCC2)C)=O)[H])O)Cl

KBR6259, WAK 6918
SMILES: C1=CC(=CC=C1N(C(C2(CCCCC2)C)=O)[H])O[H]

LSH 2344
SMILES: C1=C(C(=C(C(=C1)O)Cl)Cl)O

M5, BBJ98

- 12
SMILES: O=C(N(C1=CC(C(C=C1)=O)=O)[H])C2(C)CCCCC2.O

BBJ 98

- 11, deschloro

- [C

- O

- C]biphenyl Dimer

Trimer 1, BBJ 98

- 9

### Page 50 of 71

Code Name/ Synonym/
Chemical Name/ Formula/MW/ SMILES Chemical Structure

Trimer 2, BBJ 98

- 12

BBJ 98

- 13

* SMILES: C1=CC(=C(C(=C1NC(C2(CCCCC2)C)=O)OC3=C(C(= C(C=C3)NC(C4(CCCCC4)C)=O)Cl)Cl)Cl)O

M3 Structure not provided

M10 Structre not provided

Abbreviations MW =molecular weight; IUPAC: International Union of Pure and Applied Chemistry name; SMILES: Simplified Molecular

- input Line

- entry System



### Table A2. Summary of Maximum Degradate Amounts in Environmental Fate Studies of
Fenhexamid b

C ompound c Max Degradate % of AR Associated with Compound (Time of Peak)
Amount Detected at Final Sampling Interval in Corresponding Study Max Conc in

TFD (μg/kg soil) Hydrolysis Aqueous

Photolysis Soil

Photolysis Aerobic

Soil Anaerobic

Soil Aerobic

Aquatic

WAK 7004

-- 24 (1 d) nd (15 d) -- -- -- -- 28.0

M4

-- 26 (1 d) nd (15 d) -- -- 2.4 (360 d)a NA NA

C

- C biphenyl
dimer/
BBJ 98

- 8 -- -- 14 (1 d) 2.4 (18 d) 6 (1 d)

1 (100 d) NA

M1 Mixture

-- 27 (15 d)a

-- -- -- -- NA

M2 Mixture

-- 17 (15 d)a

-- -- -- -- NA

M7 Mixture

-- -- -- -- 9 (120 d) 4 (360 d) -- NA

M3

-- -- -- -- 4.4 (120 d) <0.1 (360 d) -- NA

### Page 51 of 71

C ompound c Max Degradate % of AR Associated with Compound (Time of Peak)
Amount Detected at Final Sampling Interval in Corresponding Study Max Conc in

TFD (μg/kg soil) Hydrolysis Aqueous

Photolysis Soil

Photolysis Aerobic

Soil Anaerobic

Soil Aerobic

Aquatic

Sulfonic Ester FEX/
ZE056401 -- -- -- -- -- 7.4 (7 d) 0.15 (100 d) NA

M9, KBR 5613

-- 6 (5 h) nd (15 d) -- -- 5 (365 d)a

-- NA

KBR 2931

-- 7 (0.5 h) nd (24 h)

-- -- -- -- NA

M10

-- -- -- -- 3.2 (251 d) 2.3 (365 d) -- NA

CH 3 - phenyl FEX/
KBR 3596/ BBJ
98

- 7 -- -- 3 (0.25 d)
2 (18 d ) 5 (3 d)

0.3 (365 d) -- -- NA

Trimer 1/
BBJ 98

- 9 -- -- 4 (0.25 d) 1 (18 d) -- -- -- NA

COC Biphenyl
Dimer/
BBJ 98

- 11 -- -- 6 (0 d) 0.5 (18 d) 4 (1 d)

0.5 (100 d) -- -- NA

Trimer 2/
BBJ 98

- 12 -- -- 5 (0.25 d) 1 (18 d) 2 (0 d)

1 (365 d) -- -- NA

KBR 6259

-- 3 (2 h) nd (24 hr) -- -- -- -- NA

NA=not analyzed; h=hours; d=days; Max=maximum; Conc=concentration; TFD=terrestrial field dissipation study; nd=not detected. Degradate structures are available in App endix A and 

### Figure 2

.

a Peak at final sampling interval in some studies
b See Appendix A for more information on source of information in this table

. c The structure of M3 and M10 are unknown.



### T able A 3 . Maximum amount of applied radioactivity present as a specified compound in
environmental fate studies submitted on fenhexamid. 1,2,3

Compound Study Type Max %AR (Sampling Interval) Final %AR (Sampling Interval) Comment MRID

Parent Hydrolysis

Not Applicable 100.1 (35 d) pH 5 44346725
100.1 (35 d) pH 7 44346725
99.0 (35 d) pH 9 44346725

Aqueous Photolysis nd (15 d) sterile water, phe 44346726 nd (24 h) natural water, phe 44346732 Soil Photolysis 1.1 (18 d) sandy loam, phe 44346728

Aerobic Soil 1.0 (365 d) Howe soil U.S., phe 44346729
1.0 (100 d) BBA 2.1 soil, phe 44346729
2.3 (100 d) BBA 2.2 soil, phe 44346729

### Page 52 of 71

Compound Study Type Max %AR (Sampling Interval) Final %AR (Sampling Interval) Comment MRID

1.0 (100 d) Laacher Hof Soil,

phe 44346729

0.6 (100 d) Howe soil U.S., phe 44346730

0.8 (100 d) Laacher Hof Soil,

carb 44346730

Aerobic Aquatic 6.82 (100 d) Lake Honniger , phe 44518701
1.14 (100 d) Lake Stanley, phe 44518701

Anaerobic Soil 3.8 (360 d) Howe soil, phe 44346731

Terrestrial Field Dissipation 0.21 mg/kg

- soil (0 d) <0.01 mg/kg

soil (120 d) Ontario, bare 44580303

0.762 mg/kg

- soil (0 d) 0.303 mg/kg

- soil (120 d) California, bare 44346724

3.292 mg/kg

- soil (0 d) 0.089 mg/kg

- soil (63 d) British Columbia,

bare 45447501

2.902 mg/kg

- soil (0 d) 0.081 mg/kg

- soil (63 d) British Columbia,

strawberrry 45447501

0.03 mg/kg

- soil (0 d) <0.01 mg/kg

soil (60 d) Ontario, bare 44580302

Major Degradates

WAK 7004 Aqueous Photolysis 23.6 (1 h) nd (15 d) water, phe 44346726

23.5 (0.5 h) nd (24 h) natural water, phe 44346732

Terrestrial Field Dissipation 0.0280 mg/kg

- soil <LOQ British Columbia,
bare 45447501

0.0206 mg/kg

- soil <LOQ British Columbia, strawberrry 45447501

M4 Aqueous Photolysis ~26.3 (1 d)* nd (15 d) water, phe 44346726

Anaerobic Soil 2.4 (360 d) 2.4 (360 d) howe soil, phe 44346731

BBJ

- 98

- 8 Soil Photolysis 13.8 (0.25,1 d) 2.4 (18 d) sandy loam , phe 44346728

Aerobic Soil 4.7 (0 d) 0.5 (365 d) Howe soil U.S. , phe 44346729

5.8 (1 d) 1.2 (100 d) BBA 2.1 soil , phe 44346729
1.5 (3 d) 0.6 (100 d) BBA 2.2 soil , phe 44346729
2.4 (1 d) 0.6 (100 d) Laacher Hof Soil

, phe 44346729
2.9 (2 d) 0.6 (100 d) Howe soil U.S., carb 44346730
1.0 (2 d) 0.2 (100 d) Laacher Hof Soil,
carb 44346730 Minor Degradates M1(mixture) 4 Aqueous Photolysis 27.3 (15 d) 27.3 (15 d) water, phe 44346726

M2(mixture) 4 Aqueous Photolysis 16.7 (15 d) 16.7 (15 d) water, phe 44346726
M7 (mixture) Anaerobic Soil 9.3 (120 d) 4.1 (360 d) Howe soil, phe 44346731

M3 Anaerobic Soil 4.4 (120 d) <0.1 (360 d) Howe soil, phe

ZE056401 Aerobic Aquatic 0.89 (14 d) 0.18 (100 d) Lake Honniger, phe 44518701
7.4 (7d) 0.15 (100 d) Lake Stanley, phe 44518701

M9 , KBR 5613 Anaerobic Soil 4.9 (365 d) 4.9 (365 d) Howe soil, phe 44346731

Aqueous Photolysis 5.9 (5 h) nd (15 d) sterile water, phe pheny Aqueous 44346726

### Page 53 of 71

Compound Study Type Max %AR (Sampling Interval) Final %AR (Sampling Interval) Comment MRID

4.4 (1 h) nd (24 h) natural water, phe 44346732

M10 Anaeroibic Soil 3.2 (251 d) 2.3 (365 d) Howe soil, phe 44346731

KBR 3596,
BBJ 98

- 7 Soil Photolysis 3.4 (0.25 days) 1.7 (18 days) sandy loam , phe 44346728

Aerobic Soil 2.8 (0 d) 0.3 (365 d) Howe soil U.S. , phe 44346729

1.7 (1 d) 0.5 (100 d) BBA 2.1 soil , phe 44346729
5.1 (3 d) 1.0 (100 d) BBA 2.2 soil , phe 44346729

3.7 (1 d) 0.4 (100 d) Laacher Hof Soil

, phe 44346729

2.2 (0 d) 0.5 (100 d) Howe soil U.S. , carb 44346730

4.5 (2 d) 0.5 (100 d) Laacher Hof Soil,
carb 44346730

BBJ 98

- 9 Soil Photolysis 4.2 (0.25 days) 1.3 (18 days) sandy loam , phe 44346728

Aerobic Soil 3.8 (0 d) 1.6 (365 d) Howe soil U.S. , phe 44346729

5.5 (1 d) 2.1 (100 d) BBA 2.1 soil , phe 44346729
1.2 (3 d) 0.7 (100 d) BBA 2.2 soil , phe 44346729

1.7 (1 d) 1.0 (100 d) Laacher Hof Soil

, phe 44346729

3.4 (0 d) 1.1 (100 d) Howe soil U.S., phe 44346730

1.1 (8 d) 0.3 (100 d) Laacher Hof Soil,
carb 44346730

BBJ98

- 11 Soil Photolysis 5.5 (0 d) 0.5 (18 d) sandy loam , phe 44346728

Aerobic Soil 2.9 (0 d) nd (365 d) Howe soil U.S. , phe 44346729

3.7 (1 d) 0.5 (100 d) BBA 2.1 soil , phe 44346729
2.9 (3 d) 2.3 (100 d) BBA 2.2 soil , phe 44346729
2.7 (1 d) 0.3 (100 d) Laacher Hof s oil , phe 44346729
2.2 (0 d) 0.1 (100 d) Howe soil U.S., phe 44346730

2.0 (2 d) 0.1 (100 d) Laacher Hof s oil,
carb 44346730

BBJ 98

- 12 Soil Photolysis 4.5 (0.25 days) 0.9 (18 days) sandy loam , phe 44346728

Aerobic Soil 2.4 (0 d) nd (365 d) Howe soil U.S. , phe 44346729

2.0 (1 d) nd (100 d) BBA 2.1 soil , phe 44346729
1.2 (3 d) 0.6 (100 d) BBA 2.2 soil , phe 44346729

1.2 (1 d) 0.6 (100 d) Laacher Hof s oil , phe 44346729

1.7 (0 d) 0.5 (100 d) Howe soil U.S., carb 44346730

1.9 (2 d) 0.5 (100 d) Laacher Hof Soil,
carb 44346730

KBR 5613 Aqueous Photolysis 5.9 (5 h) nd (15 d) sterile water, phe pheny Aqueous 44346726
4.4 (1 h) nd (24 h) natural water, phe 44346732

KBR 2931 Aqueous Photolysis 4.4 (3 h) nd (15 d) water, phe 44346726
6.9 (0.5 h) nd (24 hs) natural water, phe 44346732

KBR 6259 Aqueous Photolysis 3.2 (2 h) nd (24 h) natural water, phe 44346732
Other Degradates

CO 2 Aqueous Photolysis 39.3 (15 h) 39.3 (15 d) sterile water, phe 44346726

### Page 54 of 71

Compound Study Type Max %AR (Sampling Interval) Final %AR (Sampling Interval) Comment MRID

28.2 (24 hr) 28.2 (24 h) natural water, phe 44346732
Soil Photolysis 8.7 (18 d)M1 8.7 (18 d) sandy loam

, phe 44346728

Aerobic Soil 30 (365 d) 30 (365 d) Howe soil U.S. , phe 44346729

20.6 (100 d) 20.6 (100 d) BBA 2.1 soil , phe 44346729
19.9 (100 d) 19.7 (100 d) BBA 2.2 soil , phe 44346729
17.8 (1 d) 17.8 (100 d) Laacher Hof s oil , phe 44346729

36 (100 d) 36 (100 d) Howe soil U.S. , carb 44346730

40 (100 d) 40 (100 d) Laacher Hof s oil,
carb 44346730

Aerobic Aquatic 4.7 (100 d) 4.7 (100 d) Lake Honniger , phe 44518701

12.8 (100 d) 12.8 (100 d) Lake Stanley , phe 44518701

Unidentified Compound(s) 3 Aqueous Photolysis 13.5 (5 h)+ nd (15 d)+ sterile water, phe 44346726

Soil Photolysis 22 (0.25 d) 13 (18 d) sandy loam , phe 44346728

Unextracted
Residues Soil Photolysis 47.3 (18 d) 47.3 (18 d) sandy loam , phe 44346728

Aerobic Soil 75 (14 d) 60.9 (365 d) Howe soil U.S. , phe 44346729

58 (30 d) 50 (100 d) BBA 2.1 soil , phe 44346729
69 (100 d) 62 (100 d) BBA 2.2 soil , phe 44346729

81 (1 d) 77 (100 d) Laacher Hof s oil

, carb 44346729

60 (8 d) 50 (100 d) Howe soil U.S. , carb 44346730

40 (100 d) 40 (100 d) Laacher Hof Soil,
carb 44346730

Aerobic Aquatic 74.61 (100 d) 74.6 (100 d) Lake Honniger, phe 44518701

76.7 (60 d) 70.0 (100 d) Lake Stanley, phe 44518701

Anaerobic Soil 73.1 (360 d) 73.1 (360 d) Howe soil U.S., phe 44346731 na=not analyzed; nd=not detected; AR=applied radioactivity; d=days; h=hours ; phe=phenyl ring radiolabeled; carb=carbmoxide ring radiolabeled

1 This Table was created from information in the data evaluation records ( Cowles and Steeger, 1999, D244921 ) and the MRIDs. Many values reflect averaged data.

2 Maximum amounts of organic volatiles were minimal.

3 Many of the metabolism studies had multiple unidentified minor degradates that were not identified. They were not added together and placed under the unidentified compound(s) list as their presence was expected to have little impact on decision making.

4 M1 and M2 structures were characterized together as the exact structures and radioactivity associated with each
structure were uncertain. The maximum amount of a single compound (excluding succinic acid was reportedly 7%).
+Denotes that the value ref lects radioactivity associated with multiple compounds, when considered alone made up less than 10% of applied radioactivity.



### Mobility/Sorption Summary

Fenhexamid is classified as moderately mobile to slightly mobile with organic carbon
normalized Freun dlich soil

- water distribution coefficients (K foc 

### ) ranging from 446 to 1226 L/kg

organic carbon measured in six soils (MRID 44342722) 27



### . Linear sorption coefficients were not

27 Classification is based on the FAO classif ication system ( USEPA, 2010a )

### Page 55 of 71



### previously determined. Freundlich exponents ranged from 0.76 to 0.86 indicating t hat the equilibrium concentration in water influences sorption. The mean K f oc 

### was 878 L/kg

- organic
carbon and the coefficient of variation for K foc 

### values (32%) is less than that for K f 

### values (39%) indicating that K foc 

### values will be better at predicting sorption across soils than K f 

### values. Additionally, K f 

### s tend to be higher as the percent organic carbon increases. Consistent with water solubility increasing with pH, K foc 

### values decrease with increasing pH. Based o n the range of sorption coefficients, fenhexamid has the potential to reach ground water, especially in vulnerable sandy soils with low organic

- carbon content and/or the presence of shallow ground

water. Leaching may be mitigated by rapid formation of une xtracted residues in soils. The maximum depth at which it was detected in terrestrial field dissipation studies was 15 cm. The mobility of the degradate WAK 7004 has higher K foc 

### values (2324 to 5037 L/kg in four soils )
than fenhexamid

.

Table A3. Freun dlich Sorption Coefficients for Fenhexamid Measured at 19 o 

### C

Soil K f K foc 1/n pH %OC
Laacher Haf Germany loamy sand 8.02 446 0.83 7 1.8

Borstel
German loamy sand 10.21 888 0.86 6.3 1.2

Stanley

Kansas silty clay 10.75 1024 0.81 5.6 1.1

Howe
Indiana sandy loam 7.69 1025 0.76 7.1 0.75

Vero Beach
Florida
sand 2.45 1226 0.85 5.1 0.2

Napa
California clay loam 6.52 658 0.86 7.7 1.0



### Table A4. Freundlich Sorption Coefficients for WAK7004

Soil K F K foc 1/n pH %OC Stanley

Kansas silty clay 24.4 2324 0.86 5.6 1.1

Howe
Indiana sandy loam 26.4 2421 0.86 7.1 0.75

Vero Beach
Florida
sand 10.1 5037 0.89 5.1 0.2

Napa
California clay loam 32.1 3212 0.9 7.7 1.0

### Page 56 of 71



### Bioconcentration Summary

Bluegill sunfish ( MRIDs 44346746 ) were exposed to 14 

### C

- fenhexamid (phenyl label) for 28 days under flow through conditions at high and low concentrations (20 and 200 μg/L, pH 7.0 to 7.5; supplemental ; 20

- 23 o 

### C ). The bioconcentration factor for total radioactivity was 132

- 185 L/kg

wet weight whole fish and 36 .7 to 60.1 L/kg

- wet weight in edible tissue, and 248 to 339 in
viscera .Total 14 

### C residues in fish were measured via combustion. Tissue residues were further
characterized via solvent extraction and HPLC and LC

- MS. Transformation products observed
incl ude 4

- hydroxy

- KBR 2738, 3

- hydroxy

- KBR 2738 and KBR

- glucuronide. Conjugation occurred at the aromatic hydroxyl group and with hydroxylation of the cyclohexyl ring. The depuration half

- life was less than 1 day. As previously identified, there is still unc ertainty in the BCF as concentrations of fenhexamid and degradates were not fully characterized.

### Page 57 of 71



### Appendix B

. Screening Level Usage Analysis

Fenhexamid ( 090209 ) Screening Level Usage Analysis (SLUA)

Date: June 19, 2012

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active ingredient that is
used on agricultural crops in the United States. Pesticide usage data obtained from various sources. The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.
What does it contain?

Pesticide usage data for a single acti ve ingredient only. Agricultural use sites (crops) that the pesticide is reported to be used on. Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the sc ope of the survey and available resources. Annual percent of crop treated (average & maximum) for each agricultural crop. Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United St ates). What assumptions can I make about the reported data?

Average pounds of active ingredient applied

- Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding. Note: If the estimated value is less than 500, then that value is labeled <500. Estimated values between 500 & <1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.) Average percent of crop treated

- Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled <2.5. If the estimated value is less than 1, then the value is labeled <1. Maximum percent of crop treated

- Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.
Note: If the estimated value is less than 2.5, then the va lue is labeled <2.5.
What are the data sources used?

USDA

- NASS (United States Department of Agriculture’s National Agricultural Statistics Service)

– pesticide usage data from 200 3 to 20 10

. Private pesticide market research

– pesticide usage data from 200 3 to 20 10

. California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 200 3 to 20 10.
What are the limitations to the data?

Additional registered uses may exist but are not included because the available surveys do not report u sage (e.g., small acreage crops). Lack of reported usage data for the pesticide on a crop does not imply zero usage.

### Page 58 of 71 

### Usage data on a particular site may be noted in data sources, but not quantified . In these instances, the site would not be reported in th e SLUA.

Non

- agricultural use sites (e.g., turf, post

- harvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates. Some sites show some use, even though they are not on the label. This usage co uld be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).

June 19, 2012 Screening Level Estimates of Agri cultural Uses of Fenhexamid ( 090209 ) Sorted Alphabetically Reporting Years: 2003

- 2010

Percent Crop Ttd.

Crop Lbs. A.I. Avg. Max.

1 Apricots <500 10 10

2 Blueberries 2,000 5 15

3 Caneberries 4,000 20 40

4 Cherries 1,000 <2.5 10

5 Grapes 30,000 5 15

6 Peaches <500 <1 <2.5

7 Pistachios* 2,000 NC NC

8 Plums/Prunes <500 <1 <2.5

9 Strawberries 40,000 50 65

All numbers are rounded.

<500 : indicates less than 500 pounds of active ingredient.

<2.5 : indicates less than 2.5 percent of crop is treated.

<1 : indicates less than 1 percent of crop is treated.
* California data only

. NC: not calculated, only pounds a.i. is available.

SLUA data sources include:
USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service)
Private Pesticide Market Research California DPR (Department of Pesticide Regulation) These results reflect amalgamated data developed by the Agency and are releasable to the public.

### Page 59 of 71



### Appendix C

. SIP

/STIR M odel Resul ts

(a) SIP Version 1.0 Model Output

### Page 60 of 71



### (b) STIR Version 1.0 Model Output

### Page 61 of 71



### Appendix D . Reference List for OPPTS 835 Guidelines and 850 Guidelines Related to Fate

The Office of Prevention, Pesticides, and Toxic Substances (OPPTS) became the Office of Chemical Safety and Pollution Prevention (OCSPP) in 2011. The guidelines have not been updated since the name change and the titles still use OPPTS.

OPPTS or OCSPP
Guideline Citation

Hydrolysis
835.2120 (161

- 1) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.2120 Hydrol ysis . E.

712

- C

- 08

- 012. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 5, 2012).
Aqueous Photolysis
835.2240 (161

- 2) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.2240

Photodegradation in Water . E. 712

- C

- 08

- 013. October 2008. Office of Prevention, Pesticides, and
Toxic Substances. United States Environmenta l Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 5, 2012).
Soil Photolysis
835.2410 (161

- 3) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.2410

Photodegradation in Soil . E. 712

- C

- 08

- 015. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Acc essed May 5, 2012).

Aerobic Soil
Metabolism
835.4100 (162

- 1) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4100 Aerobic Soil

Metabolism; OPPTS 835.4200 Anaerobic Soil Metabolism . EPA712

- C

- 08

- 016 & E. 712

- C

- 08

- 017.
October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 17, 2012). Anaerobic Soil
Metabolism
835.4200 (162

- 2) Aerobic Aquatic
Metabolism
835.4300 (162

- 4) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4300 Aerobic Aquatic

Metabolism; OPPTS 835.4400 Anaerobic Aquatic Metabolism . EPA 712

- C

- 08

- 018 & E. 712

- C

- 08

- 019. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 17, 2012). Anaerobic Aquatic
Metabolism
835.4400 (162

- 3) Sorption coefficients
835.1230 (163

- 1) USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.1230

Adsorption/Desorption (Batch Equilibrium) . E. 712

- C

- 08

- 009. October 2008. Office or Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 5, 2012).
Leaching and Aged Column Leaching
835.1240 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.1240 Leaching Studies

.

E. 712

- C

- 08

- 010. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.regulations.gov/#!documentDetail;D=E PA

- HQ

- OPPT

- 2009

- 0152

- 0007 (Accessed May 5, 2012).

### Page 62 of 71

OPPTS or OCSPP
Guideline Citation

Terrestrial Field Dissipation
835.6100 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.1230

Adsorption/Desorption (Batch Equilibrium) . E. 712

- C

- 08

- 009. October 2008. Office or Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 5, 2012).
Aquatic Field Dissipation
835.6200 USEPA. 2008. Fate, Transport, and Transformation Test Guidelines. OPPTS Aquatic (Sediment)

Field Dissipation . EPA 712

- C

- 08

- 021. October 2008. Office of Prevention, Pesticides, and Toxic
Substances. United States Environmental Available at http://www.epa. gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed May 15, 2012).

Bioconcentration

Factor
850.1730 USEPA. 1996. Ecological Effects Test Guidelines. OPPTS 850.1730 Fish BCF . E. 712

- C

- 96

- 129.

April 1996. Environmental Fate and Effects Division. Office of Pesticide Programs. United States Environmental Protection Agency. Available at http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_T est_Guidelines/Drafts/850

- 1730.pdf (Accessed May 14, 2012).

Environmental Chemistry Method
850.6100 USEPA. 2012. Ecological Effects Test Guidelines. OCSPP 850.6100: Environmental Chemistry

Methods . EPA 712

- C

- 001. January 2012. Office of Chemical Safety and Pollution Prevention.
United States Environmental Prot ection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm (Accessed August 10, 2012).

### Page 63 of 71



### Appendix E

. AOPWIN V1.92 Output

SMILES : c1cc(c(CL)c(c1NC(=O)C2(CCCCC2)C)CL)O
CHEM :
MOL FOR: C14 H17 CL2 N1 O2
MOL WT : 302.20

------------------- SUMMARY (AOP v1.92): HYDROXYL RADICALS (25 deg C)

-------- Hydrogen Abstraction = 13.7303 E

- 12 cm3/molecule

- sec Reaction with N, S and

- OH = 0.1400 E

- 12 cm3/molecule

- sec Addition to Triple Bonds = 0.0000 E

- 12 cm3/molecule

- sec Addition to Olefinic Bonds = 0.0000 E

- 12 cm3/molecule

- sec **Addition to Aromatic Rings = 3.5808 E

- 12 cm3/molecule

- sec Addition to Fused Rings = 0.0000 E

- 12 cm3/molecule

- sec

OVERALL OH Rate Constant = 17.4511 E

- 12 cm3/molecule

- sec HALF

- LIFE = 0.613 Days (12

- hr day; 1.5E6 OH/cm3)
HALF

- LIFE = 7.355 Hrs ........................ ** Designates Estimation(s) Using ASSUMED Value(s)

------------------- SUMMARY (AOP v1.91): OZONE REACTION (25 deg C)

-----------

****** NO OZONE REACTION ESTIMATION ****** (ONLY Olefins and Acetylenes are Estimated)

NOTE: Reaction with Nitrate Radicals May Be Important!

Experimental Database: NO Structure Matches

### Page 64 of 71



### Appendix F . Currently Registered Products Containing Fenhexamid

Table F1. Currently Registered Products Containin g Fenhexamid

Registration
Number Product Name Registration Status 

### Company

Name Percent

Active Ingredient Active

Ingredient

264

- 780 FENHEXAMID

50 WDG Conditionally

Registered (16

- Apr

2002) BAYER

CROPSCIENCE

LP 50 Fenhexamid

264

- 785 FENHEXAMID

TECHNICAL Conditionally

Registered (07

- Jun

2002) BAYER

CROPSCIENCE

LP 98.6 Fenhexamid

66330

- 35 ELEVATE 50

WDG
FUNGICIDE Conditionally

Registered (21

- May

1999) ARYSTA

LIFESCIENCE
NORTH AMERICA,
LLC 50 Fenhexamid

66330

- 36 FENHEXAMID

TECHNICAL Conditionally

Registered (21

- May

1999) ARYSTA

LIFESCIENCE
NORTH AMERICA,
LLC 98.6 Fenhexamid

66330

- 48 CAPTEVATE 68

WDG
FUNGICIDE Conditionally

Registered (09

- Jul

2003) ARYSTA

LIFESCIENCE
NORTH AMERICA,
LLC 14.3 Fenhexamid

53.6 Captan

### Page 65 of 71



### Appendix G

. Summary of exposure pathways, endpoints, and models that will be used in
the risk assessment.

Table G1. Summary of exposure pathways, endpoints, and models used in the registration
review risk assessment for fenhexamid.
Assessed Group Endpoints

Evaluated Transport and Exposure Pathway Method of Estimating Exposure Aquatic
Vertebrates Acute: 96

- hr LC 50

Chronic: NOAEC Spray drift and runoff to water
column and sediment PRZM/EXAM S , AgDRIFT or AgDISP

Method to be determined Aquatic
Invertebrates Acute: 48

- hr LC 50 / E C 50

Chronic: NOAEC

Aquatic Plants EC 50

Terrestrial
Vertebrates Acute: Oral LD 50 /

DietaryLC 50 Chronic: NOAEC Spray Drift and direct spray to

Residues on foliage

Residues in drinking water

Inhalation

Bioconcentration /Bioaccumulation AgDRIFT or AgDISP

TREX, AgDRIFT or AgDISP

Method to be determined

Method to be determined

KABAM
Terrestrial
Invertebrates Method under development

Terrestrial
Plants EC 25, EC 05, and

NOAEC Runoff (vegetative vigor and seedling emergence) and Spray Drift (vegetative vigor)

Water used as irrigation water TERRPLANT and AgDRIFT or AgDISP

PRZM

- GW, SCIGROW, and
PRZM/EXAMs

Human Health Drinking Water See Human Health

Toxicity Assessment Surface Water

Ground Water PRZM/EXAMs

SCIGROW and PRZM

- GW

### Page 66 of 71



### Appendix H . Preliminary Rough Estimate of Exposure Assuming Unextracted Residues
are a Residue of Concern.

This analysis does not account for potential exposure with anilides as residues of concern. It only considers parent and u nextracted residues as residues of concern. Additionally, only one scenario was modeled. These are preliminary estimates of exposure only.

1 in 10 Year Estimated Environmental Concentrations of Fenhexamid and unextracted residues using PRZM/EXAMs

Residu es Fenhexamid Residue concentration in Surface Water (μg/L) Ecological Sediment Pore Water Human Health Drinking Water

peak 21

-

day 60

- day peak 21

-

day 60

- day Peak Annual Average
Fenhexamid +

U nextracted
Residues 69 45 23 15 14 12 165.2 6.9

Fenhexamid Alone 14 8.8 3.8 2.1 2.1 1.9 24 0.37



### Table H1. PRZM/EXAMs Input Parameter Values for Fenhexamid (Parent and
Unextracted Residues ) 1

Parameter Value Source Comment

PRZM Scenario FLcucumberSTD.txt

--

EXAMs environment pond298.exv (Eco)
ir298.exv (DW) --

Field Size EPA Pond (Eco) Reservoir (DW) --

Runoff flow None

-- Molecular Weight (g/mole) 302.2

-- Henry’s Law Constant (atm

- m 3 /mole) 6×10 - 11 Calculated

Vapor Pressure (Torr) 7×10 - 9 MRID 44346720
Solubility 20 MRID 44346719 pH 5

- 7

Soil

- water distribution Coefficient (Kd; L/kg soil) no input

--

Organic

- carbon
normalized soil

- water distribution coefficient (K OC ; L/ k g OC ) 878 MRID 44346722 Mean of six K F OC values. K OC values
were not calculated.

CAM 2

-- Incorporation Depth 0

-- Application Efficiency 0.95

--
Spray Drift Fraction 0.05 (Eco) 0.16 (DW) --
Application Date 16

- 10

-- Date of emergence in scenario

### Page 67 of 71

Parameter Value Source Comment

Application Rate kg a.i./hectare (lbs a.i ./A) 1 0.84 (0.75)

EFED Table 1 LUIS Report Application rates on ornamentals are

uncertain and could be higher

Number of Applications 4 Assumed from the maximum single application rate and maximum annual application rate of 3 lbs a.i./A.

Interval between Applications (days) 3 The interval between application is not specified for all uses

IPSCND 3 (Left As is on foliage)

-- -- Hydrolysis (days) 0 MRID 44346725

-- Aquatic Photolysis
Half

- life at pH 7 (days ) 0.1 MRID 44346732

--

Water Half

- life (days) Parent: 19

Parent+Unextracted: 1025 MRID 44518701 T he 90 th percentile upper confidence
bound on the mean of four half

- life

values.

Benthic half

- life (days) Parent: 345

Parent+Unextracted: 3078 MRID 44346731 Anaerobic Soil Half

- life x 3

Aerobic Soil
Metabolism Half

- life (days) Parent: 2.6
Parent+Unextracted
Residues: 700 MRID 45643802 T he 90 th percentile upper confidence
bound on the mean of four half

- life values. When a study on one soil was conducted with different rings labeled the values were averaged so that there
was one value for each soil tested. Eco=input value for ecological risk assessment; DW=input value for human health drinking water assessment All input parameters were chosen consistent with S tandard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half

- life Value s and Characterizing Pesticide Degradation

. ( Bohaty et al. , 2012 ; NAFTA,
2012 ) and Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1 ( USEPA, 2009b )

.

### Page 68 of 71



### Appendix I

. Toxicity P rofile for Fenhexamid.

Table 1. Aquatic toxicity studies for fenhexamid.

Group Species

(Common Name) Study Type

(Measured Effect) Test

Substance (% a.i.) End point

(Test Duration) Toxicity Value

m g a

. i

. /L (Acute Toxicity Category) MRID

( Study
Classification )

Freshwater Fish 1 Oncorhynchus mykiss (Rainbow trout) Acute

(Survival) Technical

92.7% L C 50

(96 hours) 1.34

(moderately toxic) 44346742

(Acceptable)

WG

- 50 (49%) L C 50

(96 hours) 1.23*

(moderately toxic) 44523605

(Acceptable)

Chronic: Early
Life

- Stage (Time to swim up) Technical

(95.9%) NOAEC

LOAEC 0.101*

0.206 44346745

(Acceptable)

Lepomis
macrochirus (Bluegill sunfish) Acute

(Survival) Technical

(94.64%) L C 50

(96 hours) 3.42

(moderately toxic) 44346741

(Acceptable)

Estuarine/
Marine Fish Cyprinodon

variegatus (Sheepshead minnow) Acute

(Survival) Technical

(≥95%) L C 50

(96 hours) 11*

(slightly toxic) 44346743

(Acceptable)

Freshwater
Invertebrates Daphnia

magna Acute

(Immobilization) Technical

(95.7%) EC 50

(48 hours) >18.8 †

(Slightly toxic to practically

non

- toxic) 44366507

(Supplemental)

WG

- 50 (49.6%) EC 50

(48 hours) 105

( Practically

non

- t oxic) 44523604

(Supplemental)

Chronic life

cycle (growth [length]; larval survival) Technical

(95.9%) NOAEC

LOAEC 1.0*

1.9 44346744

(Acceptable)

Estuarine/
Marine
Invertebrates Americamysis

bahia (Mysid shrimp) Acute

(Survival) Technical

(95.8%) L C 50

(96 hours) 4.6*

(moderately toxic) 44346740

(Acceptable)

Vascular Aquatic
Plants Lemna gibba

(duckweed) ( Frond number

,

growth rate, biomass) Technical

(97.7%) EC 50

(14 days) > 2.3 † 44731105 (Acceptable) NOAEC (14 days) 0.28*

Non

- Vascular Aquatic Plants Pseudokirchneri

ella subcapitata (green algae) ( Ce ll density) Technical (95.7%) EC 50

(120 hours) 4.82 44518706 (Supplemental) NOAEC (120 hours) 2.95

WG

- 50 (49.6%) EC 50

(72 hours) 1.37 * 44523610 (Supplemental) NOAEC (72 hours) 0.558 *

EC 50 Effect concentration for 50% of the organisms tested; NOAEC no observed adverse effect concentration

### Page 69 of 71

* Most sensitive endpoint and will be used for RQ calculations unless more sensitive data become available.

† Non

- definitive study endpoint; cannot be used to calculate RQs for risk estimation.
‡ Freshwater fish may be surrogates for aquatic

- phase amphibians.



### Table 2. Terrestrial toxicity studies for fenhexamid.

Group Species Study Type (Effect) Test

Substance
(% a.i.) Endpoint

(Test Duration) Toxicity Value

(Acute Toxicity Category) MRID

(Study Classification)

Birds ‡ Anas

platyrhynchos (mallard duck) Sub

- acute dietary

(Survival) Technical

(95.7%) LC 50

(5 days) >4,962 mg a.i./kg

diet †

(Practically non

toxic) 44346752

(Supplemental)

Colinus virginianus (Northern Bobwhite Quail) Acute oral

(Survival) Technical

(95.7%) LD 50

(14 days) >2,000 mg a.i./kg

bw †

(Practically non

toxic) 44346750

(Supplemental)

Sub

- acute dietary (Survival) Technical

(95.7%) LC 50

(5 days) > 5,469 mg a.i./kg

diet †

(Practically non

toxic) 44346751

(Supplemental)

Reproductive toxicity (Feed consumption rate) Technical

(95.9%) NOAEC/

LOAEC
(23 weeks) 2,0 74/>2,074

mg a

. i

. /kg

- diet* 44346753

(Acceptable)

Mammals Rattus

norvegicus
( Norway rat) Acute oral

(Survival) Technical

(95.5%) LD 50

(Survival) >5,000 mg a.i./kg

bw (Practically non

toxic) 44346769

Rat 2

- generation reproductive toxicity test (decreased body weights) Technical

(93.8

- 95.2%) NOAEC/

LOAEC 500/5,000 mg

a

. i

. /kg

- diet 44346803

Terrestrial
Invertebrates Apis mellifera

(honeybee) Acute Contact

Toxicity
(Survival) Technical

(95.7%) LD 50

(48 hours) >200 μg a.i./bee 44346755 (Acceptable)

Acute Oral Toxicity
(Survival) Technical

(94%) LD 50

(48 hours) >201 μg a.i./bee 44346755 (Supplemental)

Terrestrial
Plants No Toxicity Data Available

### Page 70 of 71



### Appendix J

. Data Call

- In Justifi cation Tables for Non

- guideline Studies

Study Title: Honeybee Larval Toxicity Study
Guideline Number: Non

- guideline
Test Substance: Fenhexamid

— TGAI Rationale for Requiring the Data Although fenhexamid is practically non

- toxic to adult worker bees on an acute contact exposure basis, a larval toxicity study is needed to determine the toxicity of the compound to developing brood. This study is part of EFED’s current screening level process for determining potential effects to terrestrial invertebrates. Therefore, a non

- guideline honeybee larval toxicity study is recommended. The registrant should submit a proposed protocol f or review and approval by EFED prior to initiation of the study. Practical Utility of the Data
How will the data be used?
Data will be used to assess risk to non

- target listed and non

- listed terrestrial invertebrate species. This study would allow the Agency to refine the screening

- level hazard assessment for beneficial
terrestrial invertebrates. The effects data will be use d to determine the potential for adverse effects on beneficial terrestrial invertebrates through direct effects on larval bees.

How could the data impact the Agency’s future decision

- making? EPA is required by section 7(a)(2) of the Endangered Species A ct (ESA) to ensure that any action
it authorizes or takes “... is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat ” and “ to use the best scientifi c data available ” in carrying out this obligation. The data EPA intends to call in are necessary to inform the determination required by ESA as to whether continued registration of a pesticide is or is not likely to jeopardize the species or its designated critical habitat. The lack of these data will limit the flexibility that the Agency has in coming into compliance with ESA and could result in use restrictions that are unnecessarily severe. In addition, the lack of these data may result in an uncertain a ssumed risk and potential mitigation of fenhexamid formulations under
FIFRA.

Study Title: Whole sediment chronic freshwater and/or marine invertebrate (3 Studies)
Guideline Number: Agency

- wide Guideline
Test Substance: Fenhexamid

— TGAI

Rationale for R equiring the Data The use pattern, chemical properties, estimated exposure, and toxicity profile of fenhexamid indicate need for chronic (life cycle) sediment toxicity tests to fully evaluate potential risks to benthic invertebrates. These sediment toxicity studies include two freshwater species (the midge,
Chironomus dilutus and the amphipod, Hyalella azteca ) an d one saltwater species (the amphipod, Leptocheirus plumulosus ). Multiple species are being recommended in order to account for differential sensitivity and exposure potential of benthic invertebrates to fenhexamid. This recommendation is being made beca use some K OC 

### and log K
ow 

### values in submitted fate studies
were above the thresholds of 1,000 and 3.0, respectively

. The registrant should submit a proposed protocol for review and approval by EFED prior to initiation of the study.

(Note: As an alternative to the conduct of three chronic (life cycle) sediment toxicity tests, EFED

### Page 71 of 71



### would also consider a tiered testing approach for sediment toxicity testing. In this approach, sediment toxicity testing would first be conducted with the aforementioned species u sing the 10

- d (subchronic) sediment toxicity test guidelines (OSCPP 850.1735 28 

### and 850.1740 29 

### ). Then, pending a comparison of estimated environmental concentrations (EEC) in sediment and pore water with toxicity results from the 10

- d sediment toxicity studi es, the need for one or more chronic sediment toxicity studies would be determined. This tiered testing approach has the potential advantage of reducing the number of chronic (life cycle) studies that would be needed
when results of the 10

- d (subchronic) tests in conjunction with sediment EECs indicate chronic testing is not likely to alter risk assessment conclusions. In some cases, however, this tiered testing approach may result in the conduct of both a 10

- d (subchronic) and a chronic (life cycle)
stud y. If the tiered test approach described above is not preferred, then chronic life

- cycle sediment toxicity studies be carried out on the three preferred species, C. dilutus

, H. azteca , and L. plumulosus .) Practical Utility of the Data

How will the data b e used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms
associated with uses of fenhexamid . The data will reduce uncertainties associated with the current risk assessment for benthic species and will impro ve our understanding of the potential effects of
fenhexamid on aquatic ecosystems.

How could the data impact the Agency’s future decision

- making? If the data indicates that registered fenhexamid uses may pose a risk of adverse effects to non

target benthic organisms above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in
use restrictions for fenhexamid which may otherwise be avoided, or which are unnecessarily

severe.

28 USEPA. 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/
Drafts/850

- 1735.pdf

29 USEPA. 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/
Drafts/850

- 1740.pdf