### `



# Draft Preliminary Environmental Fate and Ecological Risk

Assessment for the Registration Review C ombined with the Environmental Fate and Ecological Risk Assessment for Proposed

Amendments to Certain Labels for Flutolani l

F F

F O N H O

C H 3 

## C H 3



### CAS 079622

- 59

- 6

PC Code 128975

DP Barcode D410730, D412200



### March 1 8

, 2014

Prepared b y José L. Meléndez, Chemist Justin Housenger

, Biologist U.S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Divi sion

Environmental Risk Branch V 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 

### Reviewed by Mohammed Ruhman, Ph .D., Senior Agronomist Keith Sappington, Senior Advisor

Mah T. Shamim

, Ph.D., Branch Chief- Page 2 of 196

- 

# Table of Contents

1. Executive Summary

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

2. Problem Formulation

................................ ................................ ................................ ................................ .. 9

2.1. Nature of Regulatory Act ion

................................ ................................ ................................ ................... 9

2.2. Stressor Source and Distribution

................................ ................................ ................................ ............ 9

2.2.1. Nature of the Chemical Stressor

................................ ................................ ................................ ........... 9

2.2.2. Overview of Pesticide Usage

................................ ................................ ................................ ........... 11 2.3. Receptors

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

2.3.1. Aquatic and Terrestrial Effects

................................ ................................ ................................ ...... 12 2.3.2. Ecosystems Potentially at Risk

................................ ................................ ................................ ...... 13

2.4. Assessment Endpoints

................................ ................................ ................................ ............................ 13 2.5. Conceptual Model

................................ ................................ ................................ ................................ ... 14 2.5.1. Risk Hypotheses

................................ ................................ ................................ ................................ 14 2.5.2. Conceptual Diagram

................................ ................................ ................................ ......................... 15 2.6. Analysis Plan

................................ ................................ ................................ ................................ ........... 18 2.6.1. Measures of Exposure

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

2.6.2. Measures of Effect

................................ ................................ ................................ .......................... 21 2.6.3. Integration of Exposure and Effects

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

3. Analysis

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

3.1 Use Characterization

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

3.2. Exposure Characterization

................................ ................................ ................................ .................... 28

3.2.1. Environmental Fate and Tran sport Characterization

................................ ................................ . 28

3.2.2. Measures of Aquatic Exposure

................................ ................................ ................................ ....... 33

3.2.3. Measures of Terrestrial Exposure

................................ ................................ ................................ .. 45

3.3. Ecological Effects Characterization

................................ ................................ ................................ ...... 58

3.3.1. Aquatic Toxicity Assessment

................................ ................................ ................................ .......... 58

3. 3.2. Terrestrial Effects Summary

................................ ................................ ................................ ................ 66 Toxicity Effects on Birds

................................ ................................ ................................ ................................ . 66 Toxicity Effects on Mammals

................................ ................................ ................................ .......................... 68 Toxicity Effects on Terrestrial Plants

................................ ................................ ................................ ............. 69 Toxicity Effects on Insects

................................ ................................ ................................ ............................... 71 Toxicity Effects on Se diment

- Dwelling Aquatic Invertebrates

................................ ................................ .... 71

3.3.3. Review of Incident Data

................................ ................................ ................................ .................. 73

4. Risk Characterization

................................ ................................ ................................ ................................ ...... 73

4.1. Screening

- Level Risk Quotient (RQ) Values

................................ ................................ ........................ 73

4.1.1. RQ Values for Aquatic Organisms

................................ ................................ ................................ 74 4.1.2. RQ Values for Aquatic Plants

................................ ................................ ................................ ............... 80

4.1.3. RQ Values for Sediment

- Dwelling Organisms

................................ ................................ .............. 82

4.1.3. RQ Values for Terrestrial Organisms

................................ ................................ ........................... 89 4.1.4. Bioaccumulation Analysis Results

................................ ................................ ................................ ..... 108

4.2. Risk Description

................................ ................................ ................................ ................................ .... 111

4.2.1. Risks to Aquatic Organisms

................................ ................................ ................................ ......... 111

4.2.2. Risks to Terrestrial Organisms

................................ ................................ ................................ .... 129

5. Endocrine Disruptor Scree ning Program (EDSP)

................................ ................................ ...................... 135

6. Federally Threatened and Endangered (Listed) Species of Concern

................................ ........................ 136

6.1. Action Area

................................ ................................ ................................ ................................ ........... 137

6.2. Taxonomic Groups Potentially at Risk

................................ ................................ ............................... 137

6.3. Listed Species Occurrence Associated with Registered Uses

................................ ............................ 139

7. Conclusions

................................ ................................ ................................ ................................ ..................... 140

8. Uncertainties, Limitations, and Identification of Data Gaps

................................ ................................ ...... 145

8.1. Environmental Fate

................................ ................................ ................................ ................................ ..... 145

8.1.1. Data Gaps Uncertainties

................................ ................................ ................................ ............... 145

8.1.2. Maximum Use Scenario

................................ ................................ ................................ ................ 145- Page 3 of 196

- 8.1.3. Aquatic Modeling with PRZM/EXAMS

................................ ................................ ...................... 145

8.1.4. Buffer Zone to Estuarine/Marine Bodies of Water for the Uses on Turf

................................ . 146

8.1.5. Uncertainties regarding dilution and chemical transformations in estuaries

.......................... 147

8.1.7. Uncertainties Related to the Accumulation of Residues with Time

................................ .......... 149 8.2. Ecological Effects

................................ ................................ ................................ ................................ ......... 149 8.2.1. Terrestrial Exposure Assessment

................................ ................................ ................................ ....... 150

8 .2.2. Routes of Exposure

................................ ................................ ................................ ............................. 150 8.2.3. Age Class and Sensitivity of Effects Thresholds

................................ ................................ ................ 1 51 8.2.4. Lack of Effects Data for Amphib ians and Reptiles

................................ ................................ .......... 151 8.2.5. Use of the Most Sensitive Species Tested

................................ ................................ ........................... 151

8.2.7. Sublethal Effects

................................ ................................ ................................ ................................ ... 153

9. References

................................ ................................ ................................ ................................ ....................... 154



## Appendices

Appendix A. PRZM/EXAMS Sample Input/Output Data

................................ ................................ .................. 168 Appendix B. Example T

- REX (v. 1.5.1) Input and Output for Flutolanil

................................ ......................... 172 Appendix C. Example Terrplant (v. 1.2.2) Input and Output for Flutolanil

................................ ..................... 175 Appendix D. STIR Results.

................................ ................................ ................................ ................................ .... 176

A ppendix E. SIP Results.

................................ ................................ ................................ ................................ ....... 177 Appendix F. Classif ications of Environmental Fate Studies Submitted for Flutolanil

................................ ..... 178 Appendix G. Classifications of Ecological Effects Studies Cited in the Risk Assessment for Flutolanil

......... 180 Appendix H. KABAM Output

................................ ................................ ................................ ............................... 182 Appendix I. PFAM Default Values

................................ ................................ ................................ ........................ 187 Appendix J. Hen ryWin v.3.20 Output File and Calculation of Heat of Henry

................................ .................. 189 Appendix K. Flutolanil and its Minor Transformation Products of Environmental Fate Studies

................... 193- Page 4 of 196

- 

## 1. Executive Summary

Th e preliminary risk assessment (PRA) examines the potential ecolo gical risks

associated with labeled uses of the systemic fungicide flutolanil [N

- (3

- (1

- methylethoxy)

- phenyl)

- 2

- (trifluoromethyl)

- benzamide] , based on t he best available scientific and commercial information on the use, environmental fate and transport,

and ecological effects of flutolanil on non

- target organisms

. This assessment also serves to identify and characterize the risk of flutolanil to the prop osed

amendments to i nclude b anded a pplications on p eanuts, u se on b rassica l eafy

v egetables p lus t urnip g reens, and t urf and o rnamentals, and to i ncrease the

s easonal a pplications r ate on t urf

.

The screening level assessment concludes that the use of fl utolanil, a fluorinated toluanilide fungicide, in accordance with registered labels results for acute and

chronic risk to freshwater fish and estuarine/marine water column , and sediment

d w e l ling invertebrates

. Additionally risk above the level of concern was indicated

for nonlisted species of aquatic nonvascular plants, and listed and non listed dicot species of terrestrial plants for the uses to nursery stock and ornamentals and turf

.

Furthermor e acute risk to birds

, mammals, and freshwater water colum n and

sediment

- dwelling invertebrates is stated to have the potential to exceed the level

of concern. The rationale for this is found further below and thro ughout the risk

assessment.

Fi nally, acute risk below the level of concern was determined for estuarine/marine fish due to no mortality in the available acute study with exposure up to the limit of solubility of flutolanil. Although no chronic study is available for estuarine/marine
fish, chronic risk cannot be estimated as non

- definitive endpoint s preclude the ability to estimate toxicity by way of an acute

- to

- chronic ratio (ACR). Risk cannot be ruled out however due to the presence of behavioral effects in the acute toxicity study as well the establishment of a definitive NOAEC in the chronic fr eshwater fish study.

The distinction of potential risk to certain taxa is indicated due to several endpoints in the ecological effects studies determining non

- definitive (i.e. “>”) endpoints. This was the case for acute toxicity to freshwater invertebr ates and estuarine/marine fish, in which test organisms were exposed to concentrations up to the solubility limit of flutolanil without a definitive LC 50 

### being achieved due to lack of 50% mortality in a treatment concentration. In the case of

estuarine/ma rine fish, there was no treatment concentration including the highest tested at the limit of solubility for flutolanil where any mortality was observed yet the highest concentration at the limit of solubility for in the acute freshwater invertebrate study had 45% mortality. As a result, risk below the level of the LOC can be presumed for acute risk to estuarine/marine fish. For freshwater invertebrates, while there is uncertainty in acute RQs estimated from non

- definitive endpoints, EFED cannot discount th e mortality effects nearing the limit of solubility- Page 5 of 196

- 

### for flutolanil and therefore the acute RQs presented for freshwater invertebrates are

determined to have the potential to exceed the LOC for certain uses.

For birds and mammals , although there were no mo rtality effects in either the acute oral studies to birds and mammals and the subacute dietary studies to birds,

T

- REX derived EECs indicate residues on terrestrial food items at concentrations for

some uses at levels 4 times the level of the non

- definitiv e LD 50 

### (>2000 mg a.i/kg

bw) for birds . While there were no effects up to 20 00 mg a.i/k

- bw and 10,000 mg a.i/kg

- bw for birds and mammals, respectively, the LD 50 

### could potentially be anywhere above that level . With repeated applications and high persistenc e of
flutolanil, acute and chronic risk cannot be discounted and so certain acute RQs in

the risk estimation for birds and mammals and chronic RQs in the risk estimation

for mammals are stated to have the potential to exceed the acute LOC. For

chronic ris k to birds , a definitive NOAEC was determined for birds and so these LOC exceedances have a greater level of certainty

.

The proposed uses or label amendments considered in this assessment include brassica, cole leafy vegetables, turf, rice, and ground ban ded applications to peanuts. Adverse effects on birds that follow chronic exposure to flutolanil in laboratory studies include reductions in growth and in offspring fitness and viability;

these effe cts are seen across generations

. Adverse effects on fres hwater fish that follow chronic exposure include reductions in length and effects that follow chronic exposure to freshwater and estuarine/marine invertebrates include reductions in survival, number of young per female, and dry weight.

Expected o ff

- site t ransport of flutolanil to surface water presents risk to listed and

non

- listed species of aquatic nonvascular plants ( e.g ., algae) ; it is uncertain to what degree algicidal or algistatic effects i n the aquatic plant community may result

in indirect effects to organisms consuming algae

.

Flutolanil (with its moderately high K OC 

### ) has a relatively high propensity to sorb to

sediment s . A screening level analysis has shown flutolanil to pose chronic risk to

benthic invertebrates that have RQs above the LOC in both the pore water and sediment compartments. Additionally, based on its Kow, flutolanil may bioconcentrate in fish thus suggesting a route of exposure to birds and mammals

that could consume flutolanil contaminated fish. However, a preliminary analysi s shows that acute and chronic risk to birds and mammals consuming fish exposed to

flutolanil is below levels of concern for the majority of modeled scenarios

, presumably based on flutolanil’s readiness to depurate rapidly from tissues.

Risk determination s for the currently registered uses and proposed uses of flutolanil

are summarized in Tables 1.1 and 1.2 , respectively. These tables collapse all included modeled scenario for a given use and the reader is directed to the risk

characterization section for further information on risk determinations for different scenarios within a given use. In general, the currently registered uses on peanuts, potatoes, soybean, turf, nursery stock as well as the proposed uses on pe a nuts, brassica (cole) crops, turf, and rice all have RQs that exceed the acute and chronic- Page 6 of 196

- 

### levels of concern for estuarine/marine invertebrates in surface water as well as in the sediment. The use on nursery stock has RQs that exceed the acute and chronic LOCs for all assessed taxa while the p roposed uses on peanuts, brassica, and turf

have RQs that exceed the acute LOCs for birds.

In the aquatic environment the input half

- lives used in modeling were indicative of high persistence and further, evaluation of the results of the aquatic modeling shows an increasing trend of the EECs in PRZM/EXAMS. There are a number of reasons why the estimated environmental exposure concentrations (EECs), and consequently the RQs, may have been conservative and possibly they are overestimates. These include: a) the PRZM/EXAMS input parameters may have been overly conservative owing to the 3X uncertainty factor, b) the field dissipation studies point towards lower persistence than noted from the results of PRZM/EXAMS, c) since the chemical shows medium to high pe st resistance [ as indicated by the Fungicide Resistance Action Committee for chemicals in Group 7], it may not be applied as often as modeled in PRZM/EXAMS, and d) that the standard pond used in PRZM/EXAMS does not include flow or turnover, which may

remov e part of the flutolanil received in the pond. While these facts appear to point towards lower persistence for flutolanil than used in the modeling, there is uncertainty as to what degree there is persistence or no persistence for flutolanil. Despite bei ng conservative, the standard input values were used in the absence of additional soils and sediments (as per the current input parameter guidance). Therefore, there is uncertainty as to how much the EECs may have been

overestimated.- Page 7 of 196

- 

### Table 1 .1. Sum mary of Risk Determinations for Currently Registered Uses of Flutolanil (a bolded and shaded “ X ” represents an LOC exceedance) 9

Use (inclusive of all scenarios) FW fish FW

inverts E/M

Fish 8 E/M

inverts FW Benthic

inverts 5 E/M Benthic

Inverts 5 Birds 6 Mammal s 6 Terrestrial plants 7 Aquatic plants 4AcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicListedNon-listedListedNon-listed

Peanuts 1 X X X X X X

Potato 2 X X X X X

Cotton Soybean X X X X Sugarbeet

Rice X X X X X X X X X X

Turf 3 X X X X X X X X X Nursery Stock X X X X X X X X X X X X X X X X X X

1 Inclusive of all use s except pro posed ground banded application

2 Includes in

- furrow and seed treatment applications

3 Includes ornamental lawns and turf, recreation lawns, industrial, commercial, and residential lawns

4 Exceedances are for non

- listed non

- vascular plants

5 Chronic RQs inclus ive of all potential compartments (sediment

- based, pore water

- based, pore water/surface water

- based)

6 Inclusive of both dose and dietary based risk and of all terrestrial food items

7 Inclusive of both monocots and dicots

8 Acute and chronic risk to estuarin e/marine fish was not estimated as there were no mortalities in the acute study up to solubility limit and no chronic fish st udy

is available. An acute

- to

- chronic ratio (ACR) was not utilized to estimate chronic toxicity as there is a high level of uncert ainty in using an ACR with a non

definitive acute toxicity endpoint.

9 An italicized “ X ’ denotes that the acute or chronic exposure has the potential to exceed the LOC. See Risk Characterization section for more information.- Page 8 of 196

- 

### Table 1

. 2 . Summary of R isk Determinations for Proposed Uses of Flutolanil (a bolded and shaded “ X ” represents an LOC exceedance) 8

Use (inclusive of all scenarios) FW fish FW inverts E/M Fish 7 E/M inverts FW

Benthic

inverts 4 E/M

Benthic

Inverts 4 Birds 5 Mammals 5 Terrestrial plants 6 Aquatic plants 3AcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicListedNon-listedListedNon-listed

Peanuts 1 X X X X X

Brassica (cole leafy vegetables plus turnip greens) X X X X X

Rice X X X X X X X X X X

Turf 3 X X X X X X X X X X X

1 Ground banded applications only

2 Includes golf courses, sod farms, spot fields, residential, institutional, municipal and commercial areas

3 Exceedances a re for non

- listed non

- vascular plants

4 Chronic RQs inclusive of all potential compartments (sediment

- based, pore water

- based, pore water/surface water

- based)

5 Inclusive of both dose and dietary based risk and of all terrestrial food items

6 Inclusive of b oth monocots and dicots

7 Acute and chronic risk to estuarine/marine fish was not estimated as there were no mortalities in the acute study up to solub ility limit and no chronic fish study

is available. An acute

- to

- chronic ratio (ACR) was not utilized to estimate chronic toxicity as there is a high level of uncertainty in using an ACR with a non

definitive acute toxicity endpoint.

8 An italicized “ X ’ denotes that the acute or chronic exposure has the potential to exceed the LOC. See Risk Characterization s ection for more information.- Page 9 of 196

- 

## 2 . Problem Formulation

The purpose of problem formulation is to provide the foundation for the environmental fate and ecological risk assessment being conducted for flutolanil as follows:

• Certain p roposed label amendm ents which are described below

,

• A pproximately 17 Section 3 labels, and

• 7 Special Local Needs (Section 24c) labels approved for this chemical.

The registrant requested to include currently registered uses on an SC formulation known under

the brand name Con voy ® 

### . The proposal includes adding peanuts via banded applications ( other methods of application are already approved for peanuts) ; brassica leafy vegetables (Crop Group 5) plus turnip greens ; turf and ornamentals . Additionally, it proposes t o double the annual rate on turf in the product ProStar ® 

### 70WP Fungicide (see Section 3.1 , under the subheading

“ Proposed changes for two product labels ”)

.

The problem formulation sets the objectives for the risk assessment and provides a plan for analyzing the data a nd characterizing the risk (USEPA 1998a). As part of the Registration Review process, a detailed Problem Formulation (DP Barcode D349574) for this risk assessment was published to the docket [Docket ID: EPA

- HQ

- OPP

- 2008

- 0148] in June 9, 2008. The

followin g section summarizes the key points of that document and discusses any differences between the analysis outlined previously and the analysis conducted in this risk assessment.

2.1

. Nature of Regulatory Action

The risk assessment is con ducted as part of th e Agency’s Registration R eview process for pesticide active ingredients. The Registration Review process was established under the Fo od Quality Protection Act (FQPA 1996 ).

2.2

. Stressor Source and Distribution

2.2. 1. Nature of the Chemical Stressor

Flu tolanil ( IUPAC name α
, α
, α

- t rifluoro

- 3′

- isopropoxy

- o

- toluanilide , CAS name N

- [3

- (1

- methylethoxy) phenyl]

- 2

- (trifluoromethyl)benzamide

, CAS No. 66332

- 96

- 5, PC Code 128975) is a syst emic fungicide pesticide for the control of a number of diseases

. Flutolanil belongs to

the chem ical group phenyl

- benzamide or benzalinide fungicides

. It has a trifluoromethyl group in one of the rings and a 1

- methylethoxy group in the other. The rings a re attached by an amide

group.

According to t h e Fungicide Resistance Action Committee (FRAC, av ailabl e at http://www.frac.info/

, accessed October 21, 2013) classifies flutolanil under FRAC Code 7

. Medium to high risk resistan ce management is required for chemical belonging to FRAC Code

7

. Possible measure to pre vent resistance include (see Section 4.2.1.8): use of appropriate- Page 10 of 196

- 

### cultural practices; limit the number of fungicide applications whenever possible and rotate with chemicals belonging to other FRAC Codes; apply at appropriate rate, intervals, and crop stage s; apply making sure the crop is fully covered; and, when possible, avoid preventative applications

if the risk of disease is low. Its target site of action is Complex II; succinate

- dehydrogenase respiration inhibitor (SDHI). Succinate dehydrogenase is a n enzyme complex found in the mitochondrial membrane of eukaryotic ( i.e. , animal, plant, and fungal) cells. It is the only enzyme that participates in the citric acid cycle and the electron transport chain. The complex catalyzes the oxidation of succinat e to fumerate with the reduction of ubiquinone to ubiquinol. Inhibition of this complex results in the inability of the cell to generate adenosine triphosphate (ATP) which serves as the primary energy source. SDHI fungicides were discovered more than

40 years ago

.

The chemical profile of flu tolanil is provided in Table 2.1

. Flutolanil shows a solubility of 6.53 mg/L

, log K OW 

### of 3.7

, and low vapor pressure and Henry’s Law Constants. These properties suggest that the chemical is unlikely to volatilize to a meaningful degree. Gobas et al. 2003 and Armitage & Gobas, 2007 support the presumption, that when the log K OA 

### > 5, and log K OW 

### > 2

there is a potential for a chemical to biomagnify in terrestrial food chains. This presumption is utilized here only as a broad reference to determine the potential for biomagnification . The octanol/water partition coefficient suggests that flutolanil could bioconcentrate in fish . Even though the log K OW 

### is >2, f or flutolanil, the log K OA 

### is not > 5

. Furthermore, s ince th e fish BCF study showed a low degree of bioconcentration and rapid depuration

, high levels of bioaccumulation and biomagnifications are not expected for flutolanil ( Table 3.3 )

.

Table 2.1. Chemical Profile of Flutolanil

Property Value Reference

and Comme nts

Chemical Structure

F F

F O N H O

C H 3 C H 3

Product Chemistry

Pesticide type Fungicide (systemic)

Product Chemistry Chemical class Phenyl

- benzamide

Molecular Formula C 17 H 16 F 3 NO 2 Molecular Weight 323.3 g/mol

CAS No. 66332

- 96

- 5

CAS name α
, α
, α

- Trifluoro

- 3′

- isopropoxy

- o

- toluanilide

IUPAC name N

- [3

- (1

- Methylethoxy)phenyl]

- 2

- (trifluoromethyl)

benzamide Physical State Solid (powder) 42606601 Water Solubility 6.53 mg/L or ppm at 20 o C 41841202, 42606601- Page 11 of 196

- 

### Property Value Reference

and Comme nts

Other Solubilities Acetone 143.9 g/100 mL Methanol 23.2 g/100 m L

Ethanol 37.4 g/100 ml Dimethylformamide 302.8 g/mL

Ethyl acetate 67.5 g/100 mL Chloroform 67.4 g/100 mL

Benzene 13.5 g/100 ml Toluene 5.7 g/100 ml Xylene 2.9 g/100 ml

N

- Hexane 0.09 g/100 ml 42606601

Vapor pressure 4.87 x 10
- 8 torr at 25 o C [‘ Non

- volatile under field conditions’ (from dry non

- adsorbing surfaces) (1) ] 42606601

Henry’s Law Constant 2.12 x 10
- 9 atm

- m 3 /mol 42606601; estimated from

VP and WS

Octanol/Water Partition

Kow (Log K OW ) 5,495 ( 3.74 ) (initial conc. 10

- 2 M) 6,166 ( 3.79 ) (initial conc. 1 0
- 3 M) 42606601; unspecified

temperature

Air

- water partition coefficient (K AW ) K AW = C air /C water = Henry's Law Constant/(RT) = 8.67x10
- 8 (unitless) [Classified as ‘ Non

- v olatile from a water surface’ (1) ] Calculated ( R=8.205746x10
- 5 atm

- m 3 /

K

- mole; assumed T=298K)

Octanol

- air partition

coefficient (K OA ) K OA = K OW /K AW = 1.87x10 3 (unitless) Calculated

C water+soil /C air C water+soil /C air = ( C water /C air )(1/r + K d ) = (1.15x10 7 ) (1/6 + ( 780.7 mL/g OC )(0.02)) = 1.82 x10 8

[Classified as ‘Non

- volatile from a moist soi l’ (1), (2) ] Calculated

(1) Note that all chemicals may volatilize to some extent; this classification simply indicates that the volatility potential is very low. For classification scheme, see USEPA, 2008. See also “ Guidance for Reporting on the

Enviro nmental Fate and Transport of the Stressors of Concern in Problem Formulations,” available at

htt p://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species_reregistration_workg roup/esa_reporting_fate.htm#I (accessed October 18, 2013). (2) Assuming 2% organic carbon, soil to soil water ratio (w/w) = 6, and soil water to so il air (v/v) = 1.



### No major transformation products w ere observed in any of the environmental fate studies for

flutolanil . One minor product was commonly observed in the majority of the laboratory studies

and in the terrestrial field dissipation studies

. This minor transformation is desisopropyl flutolanil ( Table 3.4 ). Since it was only a minor product and it was often sporadically detected

, EFED did not include it as a stressor of concern in prior chemical assessments . This is consistent

with the Heal th Effects Division’s (HED) approach. The Metabolism Assessment Review Committee (MARC) met on 12/16/1999 and concluded that only the parent needs be included in drinking water exposure assessment s for flutolanil (memorandum from Manying Zue to George

Kra mer dated 01/06/2000, DP Barcode D261391)

. Additionally, there is no toxicity data available for this degradate. Therefore, no degradates were modeled in this assessment or considered stressors of concern

.

2.2.2

. Overview of Pesticide Usage

Flutolan il is an active ingredient in several formulated products for use on numerous crops
, nurseries, and turf ; it can be applied using a variety of application equipment

. Flutolanil is- Page 12 of 196

- 

### registered for use on peanuts; brassica (cole) leafy vegetables ; potatoes a nd potato seed piece treatment; cotton, sugarbeet and soybean seed treatment; rice; turf; nursery stocks, ornamentals,

and fruits (unspecified) ; and greenhouses

. It is applied via ground methods of application on all

crops , except for peanuts and rice , fo r which aerial applications are allowed

. Application rates vary by use pattern. Multiple applications are allowed for most crops (notable exceptions are seed treatments) ; the interval is usually 10

- 21 days, with an annual maximum rate of up to

~ 39

lbs a

. i

. /A per season for golf course tees, greens and aprons, and certain ornamental applications

. Specific use rates are discussed in Section 3.1.

Besides registered uses of flutolanil, t he registrant requested to include currently registered uses

on an SC f ormulation known under the brand name Convoy ® 

### . The proposal includes adding peanuts via banded applications ( other methods of application are already approved for peanuts) ; brassica leafy vegetables (Crop Group 5) plus turnip greens ; turf and ornamentals in the product Convoy ® 

### Fungicide . Also, it proposes t o double the annual rate on turf in the product ProStar ®


### 70WP Fungicide (see Section 3.1 , under the subheading “ Proposed changes for two product

labels ”)

.

2.3 . Receptors

2.3.1

. Aquatic and Terr estrial Effects

The receptor is the biological entity that is exposed to the stressor (USEPA 199 8 ). Consistent with the process described in the Overview Document (USEPA 2004), this risk assessment uses a surrogate species approach in its evaluation of f lutolanil

. T oxic ity data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate potential effects on a variety of species (receptors) included under these

tax onomic groupings.

A cute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature through EPA’s database ECOTOX ( http://cfpub.epa.gov/ecotox/ ) are used t o evaluate potential direct effects of flutolanil to aquatic and terrestrial receptors. This database is publically available..

Table 2.2. provides examples of taxonomic groups and the surrogate species tested to eva luat e

p otential ecological effects of pesticides to these non

- target taxonomic groups . The table also provides a summary of the acute toxicity classification s of flutolanil for each described tax on ; note that ecotoxicity data for animals are routinely req uired for the TGAI only

.

Table 2. 2 . Taxonomic Groups and Example Test Species for Potential Effects of Flutolanil

.

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity

Classification

Birds 1 Mallard duck ( Anas platyr hynchos ) Bobwhite quail ( Colinus virginianus ) Practically non

- toxic

Mammals Laboratory rat ( Rattus norvegicus ) Practically nontoxic- Page 13 of 196

- Taxonomic Group Example(s) of Surrogate Species Acute Toxicity

Classification

Insects Honey bee ( Apis mellifera ) Practically nontoxic

Freshwater fish 2 Bluegill sunfish ( Lepomis macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Common carp (Cyprinus carpio)

Fathead minnow ( Pimephales promelas ) Moderately toxic

Freshwater invertebrates Waterflea ( Daphnia magna ) Moderately toxic

Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus ) Moderately toxic

Estuari ne/marine

invertebrates Mysid ( Americamysis bahia ) Eastern oyster ( Crassostrea virginica ) Very highly toxic

Terrestrial plants 3 Monocots

– onion ( Allium cepa )

Dicots

– carrot ( Daucus carota ) Not classified

Aquatic plants and algae Duckweed ( Lemna gibba )

Freshwater blue

- green alga ( Anabaena flos

aquae ) Not classified

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Fre shwater fish may be surrogates for aquatic

- phase amphibians.

3 Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans.



### 2.3. 2. Ecosystems Potentially at Risk

The ecosys tems at risk are often extensive in scope ; therefore , it may not be possible to identify specific ecosystems at the screening level. I n general terms, terrestrial ecosystems potentially at

risk could include the treated site and areas immediately adjacent to the treated site that may

receive drift

, runoff

, eroded sediment

, or discharged subsurface ( ground ) water

. Such areas could include the treatment site itself

, other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, wood lands, riparian habitats

, and other uncultivated areas.

Aquatic ecosystems potentially at risk i nclude water bodies adjacent to or down stream from the

treated area and may include natural or impounded lentic systems such as ponds, lakes and reservoirs, and lotic ( flowing ) waterways

, i.e.

, streams and rivers. Aquatic ecosystems supplied by groundwater , such as cave ecosystems and areas supplied by natural springs, may be at risk if a compound has the potential to leach into the subsurface

. For uses in c oastal areas, aquatic

habitat includes estuarine and marine ecosystems. Within water bod ies, the water column,

sediment , and pore water are all compartments of potential concern.

2.4

. Assessment Endpoints

Assessment endpoints represent the actual envi ronmental value s that are to be protected, defined by ecological entities (species, community, etc. ) and their attr ibute s or characteristics (USEPA

1998 ). For flutolanil , the ecological entities assessed include the following: birds , amphibians, reptiles

, mammals, freshwater and estuarine/marine fish , terrestrial and aquatic invertebrates, aquatic sediment dwelling invertebrates, and terrestrial and aquatic plants. The attributes for- Page 14 of 196

- 

### each of these entities may include growth, survival, and reproduction. (Se e Table 2. 3 in Section

2.6.2 , the Analysi s Plan, for further discussion).

The assessment endpoints are intended to reflect population sustainability and community structure within ecosystems and hence relate t o ecosystems at risk. If risks are identified for given species/taxa based on a screening

- level assessment, then such risks might be expected to translate to higher levels of biological organization.

2.5 . Conceptual Model

For a pesticide to pose a n ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be comp lete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a plausible route of exposure. The conceptual model is intended to provide a written description and visual representati on of predicted relationships

between flutolanil

, potential routes of exposure, and the effects related to the Agency assessment endpoint s

. The conceptual model consists of two major components: the risk hypotheses and a conceptual diagram (USEPA 1998).

The conceptual model used to depict potential ecological risk s associated with the foliar uses of

flutolanil relies on previous assessments and the Agency’s current understanding of the environmental fate and ecological effects of the chemical

. The model assumes that flutolanil is capable of affecting terrestrial vertebrates and aquatic vertebrates and invertebrates , provided

that environmental concentrations are sufficiently elevated as a result of flutolanil’s current uses

. P revious risk assessments [ e. g. , DP Barcode D371381 , deal t with the proposed new uses of flutolanil as in furrow spray for brassica leafy vegetables (crop group 5), turnip greens, and ginseng and as an in furrow with post emergence spray application for sugar beets] ha d identified

pot ential acute risk to threatened and endangered species and chronic risk to non

- endangered, endangered, and threatened species of aquatic organisms including marine/estuarine invertebrates. Further, acute risk to endangered and threatened avian species had been identified.

There were acute and chronic LOC exceedances for freshwater fish and invertebrates, marine/estuarine fish, mammals, and aquatic and terrestrial plants

.

2.5. 1. Risk Hypotheses

For flutolanil , the following ecological risk hypothes is is employed for the ecological risk

assessment:
Given the registered uses of flutolanil

, and its environmental fate properties (persistence and low mobility) , there is possible acute and chronic exposure to non

- target aquatic and terrestrial organisms. Previous risk assessments have identified risk to birds, and listed

and non

- listed species of aquatic estuarine/marine invertebrate s

. This assessment tests the hypothesis that, w hen used in accordance with the label, flutolanil exposure may result in ad verse effects upon the survival, growth, and reproduction of non

- target aquatic and terrestrial plants and animals.- Page 15 of 196

- 

### 2.5.2 . Conceptual Diagram

The potential exposure pathways and effects of the registered and proposed uses of flutolanil are depicted i n Figure 2.1 . Solid arrows depict the most likely routes of exposure and effects; dashed lines depict potential routes of exposure that are not considered likely for flutolanil

. The

a application methods for the registered uses of fl utolanil involve ground applications and aerial applications (only for peanuts and rice ) . Ecological receptors that may be exposed to flutolanil following such applications include terrestrial and semi

- aquatic wildlife ( i.e. , mammals, birds,

terrestrial

- p hase amphibians, terrestrial invertebrates, and reptiles) and plants. In addition, aquatic receptors ( e.g ., freshwater and estuarine/marine fish and invertebrates, aquatic

- phase amphibians, and plants) may be exposed as a result of movement of flutolanil via spray drift and

runoff f rom the site of application

. T he conceptual framework for assessment of potential ecological risk associated with flutolanil use is depicted in Figure 2.1 ; potential endpoints, stressors, and ecological effects are identified ba sed on this model.- Page 16 of 196

- **Route of exposure includes only ingestion of fish and aquatic invertebrates Figure 2

. 1 . Conceptual Model Depicting Potential Risks to Non

- target Species from the R egistered and Proposed Use s of Flutolanil. Solid arrows depict the routes of exposure and effects which are assessed for parent flutolanil based on the available data ; dashed lines depict potential routes of exposure that are not considered likely

. 

### Stressor

Source/ Transport Pathways Direct Deposition Runoff

Erosion Leaching (Infiltration/

Percolation

Source/ Exposure
Media Terrestrial Plants

Terrestrial Invertebrates Terrestrial Plants
Soil Receiving

Water Body/
Sediment Groundwater

Tested Exposure

Rou te Ingestion Direct C ontact Root Uptake Gill or Integument Uptake

Receptors

Attribute Changes Terrestrial

Vertebrates Terrest rial Plants

Individual Animals :

Reduced survival and/or reproduction Aquatic Invertebrates Aquatic Vertebrates

**Piscivorous

mammals and birds

Individual Plants :

Seedling emergence Vegetative vigor Individual Animals:

Reduced surv ival and/or reproduction Plant P opulation : Reduced population growth

Aquatic Plants Uptake/ Adsorption Spray Drift Volatilization Atmospheric Transport 

### Flutolanil

Direct Contact

Terrestrial

Invertebrates- Page 17 of 196

- 

### For a ll the possible uses of flutolanil (those already registered and proposed label amendments )

, the sources and mechanisms of release of the compound are from ground or aerial ( aerial only

for peanuts and rice) spray applications. Surface runoff from the are as o f application is assumed to depend on factors such as topography, irrigation, and rainfall events. Direct deposition may result in contamination of food items that may be consumed by terrestrial organisms. Spray drift results in contaminated adjacent areas, including bodies of water.

For aquatic receptors, the major point of exposure is through direct contact with the water column, sediment, and pore water (gill/ integument) contaminated with spray drift (from spray application) and/ or runoff from tr eated areas. Indirect effects to aquatic organisms (especially fish) can also occur through impact to various food chains. The representative aquatic receptors are certain freshwater and estuarine/marine fish, invertebrates, and aquatic plants. The majo r point of exposure for terrestrial animals is consumption of food contaminated with residues such as grass, foliage, and small insects. The representative terrestrial receptors are mammals, birds, and, in certain cases, terrestrial plants. The attribute changes used to assess risk terrestrial receptors depend on the type of test ( e.g. , reduced survival, growth, or reproduction for animals and seedling emergence and vegetative vigor for plants). It should be noted, that these species

do not cover all the possible species in the animal and plant kingdoms; certain taxa are considered as surrogates for other taxa. For example, fish are considered surrogates for aquatic phase amphibians.

The potential for bioaccumulation of flutolanil will also be examined in the risk assessment.

Because flutolanil has a fairly high K OW 

### (log K OW 

### = 3. 79 ; MRID 42606601; unspecified

temperature ) and the chemical appears to be persistent in water and sediments under most
environments , there is a potential for bioaccumulation. However, t he maximum

bioconcentration factor was 150 L/kg whole fish and depuration rate was rapid (>95% of the total radioactive residues depurated in 3 days

, MRID 41841214 & 41841215 ) . B ioaccumulation will be assessed using the results from bioaccumulat ion in fish studies, as well as the K OW 

### (based) A quatic B io A ccumulation M odel, version 1.0, 2009 ( KABAM ) (refer to Section 4.1.4 ).

For terrestrial organisms, the primary route of exposure assessed at the screening level is the dietary route

, via consumpti on of food items such as plant leaves or insects that have flutolanil residues as a result of spraying. The assessment considers exposure of non

- target terrestrial invertebrates through oral ingestion and through contact, e.g., as a result of direct depos ition or spray drift. Direct contact and spray drift are the major routes of exposure considered for terrestrial and wetland (riparian) plants.

Based on flutolanil’s relatively low vapor pressure 4.87 x 10 - 8 

### mm Hg and Henry’s Law

Constant of 2.12 x 10 - 9 

### atm

- m 3 

### /mol, and its moderate tendency to sorb to soils and sediments (mean K OC 

### = 781 mL/g OC 

### ), the chemical is not expected to volatilize readily or substantially

. Furthermore, it is not expected to leach to groun d water in meaningful amounts (compared to

e xposure to surface waters)

. An analysis using the S creening T ool for I nhalation R isk ( STIR

, v.1.0 , 11/23/2010 ) (see Section 2.6.2 ) however indicates that for a nursery stock use, turf use, and golf course greens use, that inhalation of the droplets of vap or phase spray drift from flutolanil applications would result in a potential pathway of concern. T he S creening I mbibition- Page 18 of 196

- 

### P rogram (SIP , v.1.0 , 7/6/2010 ) indicates that drinking water exposure alone is not a potential pathway of concern

. Additionally, t his ecological risk assessment does not account for possible ingestion of flutolanil residues in contaminated grit or from preening activities of terrestrial animals, and it does not evaluate potential uptake through dermal absorption.

2.6 . Analysis Plan

2.6.1 . Measures of Exposure

2.6.1.1. Measures of Aquatic Exposure

Measures of exposure to aquatic animals and plants are concentrations in surface water and pore water simulated by the P esticide R oot Z one M odel (PRZM v3.12.2, May 12, 2005) and Ex posure A nalysis M odeling S ystem (EXAMS v2.98.04.06, Apr. 2005), coupled with the input

P RZM/ E XAMS shell pe5 (August 2007), to generate estimated environmental concentrations (EECs) of flutolanil that may occur from use on adjacent crops based on maximum labeled single and seasonal use rates among many other parameters ( Table 3.5 ) . The EECs used in

assessment of acute risk are 1

- in

- 10 year return frequency daily maximum values (referred to as “peak” values). For chronic risk assessment, mean concentratio ns over a specified duration are generated. In both cases, each modeled site is selected to represent a site expected to be more vulnerable to runoff than most locations where use may occur ( e.g. , based on the crop being grown). The EXAMS model simulates the subsequent fate of the pesticide in an adjacent receiving water body. As routinely employed in ecological risk assessment, the receiving water body is assumed to be a static, 1

- hectare pond of 2

- meter depth (the “standard pond”), into which

a 10

- hect are cropped field drains ( USEPA 2009a ). More detailed information about the models

can be found elsewhere. 1



### For the applications on rice, the P esticides in F looded A pplications M odel (PFAM v.1.00, dated January 23, 2013) will be used. The primary intent during the development of PFAM was to produce a flooded agriculture model for use in pesticide regulatory work. The user interface was specifically designed with this intent. Its greatest strength is for analysis of long

- term pesticide use for hypotheti cal scenarios, as is done during the pesticide registration process. The duration of PFAM simulations is as long as the available meteorological data. Pesticide application and flooding sequences are mapped onto the time series in 1

- year cycles for as lo ng as the simulation continues. Thus, as is typical of a U.S. exposure assessment, the pesticide is assumed to be used every year for 30 years (the length of the U.S. meteorological files). Currently output is delivered as released mass of pesticide as w ell as a daily time series of concentrations. PFAM

version 1.00 was developed as a flooded agriculture model for use in pesticide regulatory work. This model has been developed under USEPA Guidance ( USEPA, 2009 e). External independent

evaluations have b een positive ( Luo, 2011 ). Additionally, a peer reviewed journal article describing PFAM’s mathematics, theories and performance with respect to the requirements of a regulatory model has also been published (Young, 2012).

1 http://www.epa.gov/pesticides/science/models_db.htm- Page 19 of 196

- 

### PFAM is conceptualized in Figure 2.2 and includes both hydrological processes and chemical processes. The water body depth may change due to precipitation, refill, drainage, evaporation,

and weir

- height changes. The model consists of two regions : a water column and a benthic region. E ach individual region is completely mixed and at equilibrium with all phases within the individual region, and equilibrium within each region follows a linear isotherm ( USEPA 2004 a)

. The two regions are coupled by a first

- order mass

- transfer process. Equ ations for c hemical processes ( i.e ., hydrolysis, bacterial metabolism, photolysis, and sorption) within each region are similar to USEPA 2004 a

. The model accounts for plant growth, metabolism, hydrolysis, photolysis, and metabolism in water, sediment, an d soil (when no water is present), sorption, and volatilization. Water, sediment, and pesticide may flow out of the field. Changes in water body conditions (temperature, water levels, wind speed, etc

. ) and the resulting changes in degradation

rates occur on a daily time step. Pesticide application and flooding sequences are mapped onto

the time series in 1

- year cycles for the length of the simulation. For instance, a typical exposure assessment assumes the pesticide is used every year for 30 years (the length of most EFED meteorological files). Output is delivered as released mass of pesticide as well as a daily time

series of concentrations.

Figure 2.2 . Conceptual model of hydrological and chemical processes in PFAM- Page 20 of 196

- 

### 2.6.1.2. Measures of Terrestrial Expos ure

Terrestrial wildlife are exposed to flutolanil via consumption of residues on food items generated by spray applications

. For spray applications, the T

- REX model ( T errestrial R esidue EX posure model ; v. 1. 5 .2 ; June 6, 2013 2 

### ) is used to predict dietar y exposure to flutolanil residues on foliar surfaces and insects using the Kenaga nomogram as modified by Fletcher (Hoerger and Kenaga

1972

, Fletcher et al. 1994). A default 35

- day foliar dissipation half

- life is used for terrestrial exposure modeling in this assessment , as suitable foliar dissipation data specific to flutolanil are not available ( e.g. Wi llis and McDowell 1987). Estimated exposures of terrestrial insects to
flutolanil are evaluated in terms of the insects’ potential relevance as dietary i tems for terrestrial

vertebrates and for use in risk characterization for listed terrestrial invertebrates

. For certain uses of flutolanil including seed treatment uses (specifically, incorporation depth) and soil drench
uses, T

- REX is unable to simulate label specifications. This is further discussed in Section 3.2.3.

The TerrPlant ( v

. 1.2.2 ; December 26, 2006) model is used to derive EECs relevant to terrestrial and wetland plants for the proposed new use s of flutolanil

. The model employs the assumpti on that default fractions of the intended application are transported to an adjacent field through runoff and spray drift. Measures of exposure to terrestrial plants are expressed as a fraction of

the mass of the flutolanil applied to the treated field

.

STIR was used to calculate an upper bound estimate of exposure using flutolanil’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates results fro m several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the “six

- pack” of core studies, which are a series of six guideline studies (including acute oral, acute inhalation, acute dermal contact, and others) that are submitted to the Registration Division of the Office of Pesticide Programs for technical and formulated products of a pesticide ( rat oral LD 50 

### = >10000 mg/kg bw , MRID 40342905 ; and rat inh a lation LC 50 

### >5.98 mg/L, MRID 40342910

, respectively) as well as the most sensitive acute oral avian toxicity endpoint (bobwhite quail

LD 50 

### >2000 mg/kg bw, MRID 40342930 ). Based on the results of the STIR model ( Appendix

F ) , exposure through inhalation of spray drift of the vapor phase of flutolanil was determined to be a potential pathway of concern for avian species on an acute exposure basis.

Th e inhalation pathway via spray drift and/or vapor

- phase of the pesticide is of potential significance. This pathway will be explored further by request ing additional to xicity or exposure

data (non

- guideline acute avian inhalation toxicity) that may reduce uncertainty and the incorporation of this data into the inhalation risk assessment for birds and mammals. It is noted however, that this result was indicated for three uses; golf course greens

, tees, and aprons ; golf course fairways, and nursery stock, ornamentals & fruits (unspecified)

. For a sample of the output generated by STIR v.1.0, please see Appendix D . Detailed information about the STIR

v.1.0 tool can be found on the EPA’s website at: http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial

.

2 Information about the models can be found at http://www.epa.gov/pesticides/science/models_db.htm- Page 21 of 196

- 

### B ioaccumulation will be assessed using the results from bioaccumulation in fis h stud ies, as well as the KABAM model, adjusting for biotransformation rates. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. More information about this model can be found at the following link: http://www.epa.gov/oppefed1/models/water/kabam/kabam_user_g uide.html

.

2 .6.2 . Measures of Effect

Measures of effect are obtained from a suite of registrant

- submitted guideline studies which were conducted with a limited number of surrogate test species ( Table 2.2. ) . The test species are not intended to be representative of the most sensitive species but rather were selected based on their ability to thrive under laboratory conditions. Toxicity testing reported in this risk assessment
utilizes surrogate species to represent all freshwater fish (2000+) and bird (680+) species in the

U.S. T he publically available ECOTOXicology database (ECOTOX), was searched in October

2013 to identify whether additional, more sensitive ecolo gical effects data were available for

flutolanil ; however, no more useful data were identified ( USEPA 20 1 2 ).

The acute measures of effect used in this screening

- level assessment are the LD 50 

### (Lethal Dose),

LC 50 

### (Lethal Concentration)

, EC 50 

### (Effects Concen tration) , and IC 50 

### (Inhibition Concentration)

. These are measures of acute toxicity which result in 50% of the respective effect in tested organisms. The endpoints for chronic measures of exposure are the NOAEC (No Observed Adverse Effects Concentration) and the NOAEL (No Observed Adverse Effects Level). Toxicity studies were submitted for freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants, sediment

- dwelling organisms, birds, mammals

, and bees

. The endpoints used for risk characterization were derived from studies which underwent review and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from guidelines but the r esults we re considered to be scientifically valid and suitable for quantitative risk assessment ).

2.6.3 . Integration of Exposure and Effects

The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecologic al effects on non

- target species. For the risk assessment of flutolanil , the risk quotient (RQ) method is used to compare estimated exposure and measured toxicity values. The RQ method involves dividing EEC s by point estimates of the most sensitive acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s L evels of C oncern (LOC ) (USEPA 2004) ( Table 2.3 ). These criteria are used to indicate when applications of flutolanil , as directed on the label, have the potential to cause adverse e ffects to non

- target organisms.- Page 22 of 196

- 

### Table 2.3. Agency Risk Quotient (RQ) Metrics and Levels of Concern (LOC) Per Risk

Class.

Risk Class Risk Description RQ LOC

Aquatic Animals (fish and invertebrates)

Acu te Potential for effects to non

- listed animals from acute

exposures Peak EEC/LC 50 1 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non

- listed and listed animals from chronic exposures 60

- day EEC/NOAEC (fish) 1 21

- day EEC/NOAEC (invertebrates)

Aquatic Plants

Non

- Listed Potential for effects to non

- listed plants from exposures Peak EEC/LC 50 1 1

Listed Potential for effects to listed plants from exposures Peak EEC/NOAEC 1

Terrestrial Animals (mammals and birds) 2

Acute Potential for effects to non

- listed anim als from acute

exposures EEC/LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification EEC/LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute L isted Species Listed species may be potentially affected by acute

exposures EEC/LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals from chronic exposures EEC/NOAEC 1

Terrestrial and Semi

- Aquatic Plants

Non

- Listed Potential for effects to non

- target, non

- listed plants from

exposures EEC/ EC 25 1

Listed Plant Potential for effects to non

- target, listed plants from

exposures EEC/ NOAEC 1 EEC/ EC 05

1 LC 50 or EC 50

. 2 EEC b ased on upper bound Kenag a nomog ram values for foliar exposure.



### The Agency uses the probit dose

- response relationship as a tool for providing additional information on the potential for acute direct effects to individual listed species and aquatic animals that may indirectly affect the listed species of concern (USEPA 2004). As part of this evaluation, the acute RQ for listed species is presented in terms of the chance of an individual event ( i.e. , mortality or immobilization) should exposure at the EEC actually occur for a species

with sensitivity to flutolanil on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose

- response relationship available from the toxicity study used to establish the acute to xicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is based on the mean estimate of the slope and an assumption of a probit dose

response relationship. I n addition to a single effects probability estimate based on the mean,- Page 23 of 196

- 

### upper and lower estimates of the effects probability are also provided to account for variance in the slope, if available. If no dose response information is available to estimate a sl ope for this analysis, a default slope assumption of 4.5 (with lower and upper bounds of 2 to 9) is used (Urban and Cook 1986).

Individual effect probabilities are calculated based on an Microsoft  

### Excel spreadsheet tool IEC

v 1.1 ( I ndividual E ffect C hanc e Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope paramete r in the spreadsheet. The desired threshold for the probability of an individual effect is entered as the listed species LOC or based on the calculated acute RQ, if

available.



## 3. Analysis

3.1 Use Characterization

There are approximately 1 5 Section 3 end us e labels, 2 Section 3 Technical labels, and 7 Special

Local Needs (Section 24c) labels for flutolanil. Flutolanil can be formulated in products that contain solely flutolanil ( e.g. , Flutolanil 40SC) or in formulations with other active ingredients

such as chlorothalonil, mancozeb, and propiconazole.

A summary table of all use patterns in the current and proposed labels, is presented below ( Table

3.1 ). Two labels involved in label amendment actions included in this assessment are Convoy ®


### Fungicide (also referred as Flutolanil 40SC Fungicide) (EPA Reg. No. 71711

- 28), and ProStar ®


### 70 WP Fungicide (EPA Reg. No. 432

- 1223). Convoy ® 

### is a suspension concentrate containing 3.8 lb a.i./gallon and 40.0% active ingredient. ProStar ® 

### 70 WP Fungicide is a wettable po wder packaged in water soluble bags, containing 70.0% active ingredient.

Table 3. 1

. Summary of Use Information for F lutolanil Based on Current and Proposed

Uses (Proposed Amendments are Bolded)

USE MAXIMUM

SINGLE

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

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE (lbs. a.i./A) MINIMUM

INTERVAL

BETWEEN

APP S

. (days) APP. METHOD INCORPO

RATION

DEPTH (inches) Food Crops

Peanuts 0.950 lb/ A 1

( 1 .90 lb/A

broadcast equivalent ) 1 0.950

lb/ A 1

( 1.90 lb/A

broadcast equivalent ) N/A Ground banded applications , 40

- 60 days after planting; PHI=90 days 0

Peanuts 0.475,

0.950 4,

2 1.90 10,

21 Ground or aerial or chemigation , begin applications ~45

- 60 days

after planting, PHI=40 days 0- Page 24 of 196

- USE MAXIMUM

SINGLE

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

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE (lbs. a.i./A) MINIMUM

INTERVAL

BETWEEN

APP S

. (days) APP. METHOD INCORPO

RATION

DEPTH (inches)
Peanuts 0.742 1 0.742 N/A In furrow 4

- 8 inch band application at plant prior

to covering with soil (Flutolanil 40SC label) 1

- 2 2

Peanuts 2.00, 1.00,

0.50 1, 2,

4 2.00 N/A, 30,

10 Ground, aerial, and chemigation postplant applications 50

- 70 days after planting (1, 2, or 4 appli cation programs)

(disallowed in CA) 0

Brassica (cole) Leafy

Vegetables (Crop Group 5) plus Turnip

Greens 4 0.772 1 0.772 N/A In a narrow band directed at transplanted plant bases immediately after transplanting in 30

- 50 gallons per acre; or to the

row at p lant as an in

furrow directed spray; or, as soil drench at planting; PHI=45 days 0

Potatoes 0.77 1 0.77 N/A In furrow application

to a 4

- 8 inch band prior to covering with

soil 2

- 4 5

Potato seed piece

treatment 0.36 1 0.36 N/A Seed piece treatment 2

- 4 5

C otton seeds

treatment 6 0.0227 1 0.0227 N/A Seed treatment equipment 3⁄4

- 11⁄2 7

Soybean seeds

treatment 6 0.200 1 0.200 N/A Seed treatment equipment 1

- 11⁄2 8

Sugar beet seeds

treatment 6 0.0057 1 0.0057 N/A Seed treatment equipment 3⁄4

- 1 1⁄4 9

Rice 0.980,

0.490 1,

2 0.980 N/A,

10 Ground or aerial; 1 st
application 7

- 14 days after panicle

differentiation ; one or two application programs

available 3 0

Turf Uses

Turf (golf courses, sod

farms, spo r t fields, residential, institutional, municipal and commercial areas) 8.6 2 17.1 /y ear 10 14 Broadcast application 0

Golf course greens,

tees and aprons;

--- Fairways 8.56;

--- Assume

9.77 (4.88 in

FL) ~ 5 39.1;

---

9.77 (4.88 in

FL) 14 Broadcast application 0

Ornamental lawns and

turf ; r ecreation area

lawns; r esidential

lawns 4 .94

~ 4 19.55 14 Broadcast ground

when needed 0- Page 25 of 196

- USE MAXIMUM

SINGLE

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

OF APPS.

AT MAX

RATE MAXIMUM

SEASONAL

APP. RATE (lbs. a.i./A) MINIMUM

INTERVAL

BETWEEN

APP S

. (days) APP. METHOD INCORPO

RATION

DEPTH (inches)
Commercial/ Industrial

lawns 5.94

~ 4 19.54 14 Ground 0

Nursery Stock, Ornamentals and Fruits (Unspecified) Nursery stock,

Ornamentals & Fruits (unspecified) 14.0 4 NS NS Soil drench (ground or raised beds) N/A

Nursery stock,

Ornamentals & Fruits (unspecified) Assume

9.78 11 4 39.1 10 Broadcast, foliar N/A

Nursery stock,

Ornamentals & Fruits (unspecified) Assume

2.1 12 2 4.2 14 Sprayer, foliar (NY) 13 N/A

Nursery stock,

Ornamentals & Fruits (unspecified) 28.6 4 NS 21 Soil drench (plant bed) N/A

Nursery stock,

Ornamentals & Fruits (unspecified) 42.9 4 NS 21 Soil drench, chemigation (containerized 14 ) N/A

Greenhouse Greenhouse (in use) Various 2 or 4 NS, 4.2 or

39.1 NS, 14 or

21 Broadcast, chemigation, dip tre atment, soil drench N/A

Footnotes : NS=not specified; N/A=not applicable 1 Assuming a 16

- inch band and 32

- inch row spacing, the maximum rate is 0.95 lb a.i./A for banded applications. Banded applications on peanuts represent one of the newly proposed chan ges hereby assessed.

2 Seeding depth for peanuts is typically 1

- 2 inches (see e.g. , Texas Peanut Production Guide, Texas Cooperative Extension, Texas A&M University System).

3 Restriction: Do not apply this product within three miles of any estuarine/marin e waterways or watershed.

4 Includes the following crops: Broccoli; broccoli, Chinese (gai lon); broccoli raab (rapini); Brussels sprouts; cabbage; cabbage, Chinese (bok choy); cabbage, Chinese (napa); cabbage, Chinese mustard(gai choy); cauliflower; caval o broccolo; collards; kale; kohlrabi; mizuna; mustard greens; mustard spinach; rape greens. Even though these crops are already approved, they are proposed in the label for Convoy ® Fungicide.

5 Source for incorporation depth of seed pieces: FL and TX crop profiles, from http://www.ipmcenters.org/CropProfiles/ (accessed 08/29/13).

6 The stated application rate for cotton, soybean and sugar beets, the application rate is 0.12 lb a.i./100 lb seeds. The pl anting rates are as follows (reference, T

- REX v.1.5.2): cotton 18.9 lb seeds/A; soybean 167 lb seeds/A; and, sugar beets 4.75 lb seeds/A. 7 Source for soil incorporation depth for cotton seeds: Cotton Production Manual. 1996. E dited by S. Johnson Hake, T. A. Kerby, K. D. Hake. University of California Division of Agriculture and Natural Resources. Publication 3352. p. 25. Available from Google Books at http://books.google.com/ (accessed 08/29/13).

8 Source for incorpor ation depth: MS soybean crop profile, from http://www.ipmcenters.org/CropProfiles/ (accessed 08/29/13).

9 Source for incorporation depth: MT and CO sugar beet crop profile s , from http://www.ipmcenters.org/CropProfiles/ (accessed 08/29/13).

10 Review of previously approved labels for this chemical shows that this application rate is twice as high as previously approved. Increasing the annual rate is a nother of the changes proposed that are being evaluated in this document. For certain pests, the chemical should not be applied to more than 10,000 square feet per acre of turf area. However, for certain other pests ( e.g. , brown ring patch/Waitea patch)

, such a restriction is not applicable. For use rates greater than 4.4 fl oz per 1,000 square feet (~8.4 lb a.i./A), do not apply CONVOY ® within 100 feet of any freshwater or marine estuary, ditches, drainage tiles, or other waterway that drain directly (w ithin 1⁄2 mile or 2640 ft) into estuaries. For use rates greater than 2.2 oz per 1,000 square feet (~4.2 lb a.i./A), do not apply ProStar 70WP Fungicide within 100 feet of an estuary or marine habitat or within 100 ft of any ditches, drainage tiles, or othe r waterway that drain directly (within 1⁄2 mile or 2640 ft) into estuaries or marine habitats. 11 This value represents one fourth of the maximum seasonal application rate. 12 This value represents half of the maximum seasonal application rate.

13 Instructio ns for use in NY.

14 Restrictions in certain counties of NY.- Page 2 6 of 196

- 

### Methods of application for flutolanil include banded applications in furrow or on transplanted plants, seed treatments (potato seed pieces, cotton, soybean, and sugar beet seeds treatment),

foli ar applications which could include both ground or aerial applications (aerial applications are allowed on rice and peanuts). For certain uses there are restrictions on applications in certain New York counties ( i.e. , Nassau and Suffolk).

Proposed change s for two product labels

T he registrant requested to include currently registered uses on an SC formulation known under the brand name Convoy. The proposal includes adding peanuts (via banded applications since other methods of application are already ap proved for peanuts), brassica leafy vegetables (Crop Group 5) plus turnip greens, and turf and ornamentals in the product Convoy ® 

### Fungicide, and to double the annual rate on turf in the product ProStar ® 

### 70WP Fungicide as explained below.

Convoy ® 

### Fungicide

Peanut is already an approved use; however, a change to the Convoy ® 

### Fungicide label includes the addition of banded applications. The maximum rate per acre is the same than for previously approved uses.

Furthermore, brassica (cole) leafy vegetables (Cr op Group 5), plus turnip greens, are also approved crop s ( i.e.

, approved for other products), which are being proposed to be included in the label for Convoy ® 

### Fungicide.

For the use of flutolanil on rice in this product, the lower end of the application r ate range was slightly increased. The maximum rate remained the same (changed from 11.8

- 33.0 fl oz product/A to 12.0

- 33.0 fl oz/A or 0.356

- 0.980 lb a.i./A ).

ProStar ® 

### 70WP Fungicide and Convoy ® 

### 40SC Fungicide

Lastly, the registrant is proposing to includ e applications on turf to the product Convoy ® 

### 40SC and double the application rate on turf from a maximum yearly rate of 8.6 lb a.i./A to 17.1 lb a.i./A, by adding a second application for the product ProStar ® 

### 70WP.

Examples of Environmental Hazard Statem ents

ProStar ® 

### 70WP Fungicide

This product is toxic to aquatic invertebrates. For terrestrial uses, do not apply to water, areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposin g of equipment washwaters.”

Convoy ® 

### Fungicide

“This product is toxic to fish and invertebrates. Do not apply to water, areas where surface water- Page 27 of 196

- 

### is present, or to intertidal waters below the mean high water mark. Do not contaminate water

used for water ing livestock or domestic purposes. Exposed treated seed or seed pieces may be hazardous to birds or other wildlife. Cover or collect treated seed spilled during loading and planting. Dispose of all excess treated seed and seed packaging by burial away f rom bodies of water. Do not contaminate bodies of water when disposing of planting equipment wash water.”

Certain language is presented in the label for Convoy ® 

### Fungicide . It is related to spray drift; however, it is advisory in nature and not mandatory and, thus, it is not further provided in this

document.

Other Label Information

L abels also have restrictions for applications near marine/estuarine areas. For example, the proposed label for Convoy ® 

### Fungicide , for the use on rice, the following statem ent is shown in

the supplemental label: “ This pesticide is toxic to shrimp. Do not apply this product within three miles of any estuarine/marine waterways or watershed.” Further, for the same use

, “Flooded fields may be used for aquaculture of crayfish on ly following rice harvest.”

Additionally, for the uses on turf the following label statements appear in the label, “ For use

rates over 2

. 2 oz per 1,000 sq. ft. do not apply ProStar 70 WP Fungicide within 100 ft

. of any estuary or marine habitat or within 100 ft

. of any ditches, drainage tiles

, or other waterways that
drain directly into (within 

## 1⁄2 mile of estuaries or marine habitats )

. ”

“Use Precautions for Turf Application For use rates greater than 4.4 fl oz per 1,000 square feet, do not apply Flutolanil 40SC within 100 feet of any freshwater or marine estuary, ditches, drainage tiles, or other waterway that drains directly (within 1⁄2 mile) into estuaries. Do not apply more than 13.25 fl oz per 1,000 square feet as a broadcast application during a single g rowing season. ” [Note Flutolanil 40SC is the same product as Convoy ® 

### 40SC.]

Usage of Flutolanil

According to the Screening Level Usage Analysis (SLUA) provided by the Biological and Economic Analysis Division (BEAD) dated February 2013, the major use f or flutolanil is peanuts, followed by potatoes. Rice appears to be a minor use for this chemical; furthermore, the maximum percentage crop treated for this crop is only <2.5% ( Table 3.2 )

. The SLUA does not

include non

- agricultural uses such as turf.

Tab le 3. 2 . Estimates of Agricultural Usage of Flutolanil (Reporting Timeframe: 2004

- 2011) (OPP/BEAD).

Crop Lbs. A.I. Percent Crop Treated

Average Maximum

Peanuts 100,000 10 20

Potatoes 40,000 10 20
Potatoes, Seed Treatment 10 ,000 5 10- Page 28 of 196

- Crop Lbs. A.I. Percent Crop Treated

Average Maximum

Rice 2,000 <1 <2.5 Report dated February 2013.

All numbers rounded. <1 less than 1% crop treated <2.5 less than 2.5% crop treated Data sources: Screening Level Usage Analysis (SLUA), OPP/BEAD, report dated February 7, 2013. These results

ref lect amalgamated data developed by the Agency and are releasable to the public. SLUA data sources include:

USDA

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

Private Pesticide Market Research



### Rice Growing Pra ctices

Since flutolanil has uses on rice, certain relevant rice growing practices are important in estimating exposure concentrations. These are explained in Appendix L

.

3.2

. Exposure Characterization

3.2. 1. Environmental Fate and Transport Characterizat ion

Environmental fate characteristics of the parent compound flu tolanil are listed in Table 3. 3 and are discussed in greater detail following the table . The status of the environmental fate data requirements is presented in Appendix F

.

Table 3. 3 . Summ ary of Environmental Fate Properties of Flutolanil

Guideline Data Requirement Study MRID (Classification) Results

835.2120 Hydrolysis 40342940 (A) Stable at pH 5, 7, and 9

.

835.2240 Photolysis in

Water 41841208 &

41841209 (A) Stable at pH 7

.

835.2410 Photodegradation

on Soil 41841210

43175810 (A) Stable (u pgraded study , see below ).

Additional data submitted by the registrant to upgrade

41841210.

835.4100 Aerobic Soil

Metabolism 40342941 (A)

45756601 (A) t 1/2 = 190 days ( clay loam ); 320 days ( loam); and 300 days (sandy loam) at 30 0 C . Less than 3% of the applied

was detected as DIP.

t 1/2 = 21 7 days (sandy loam) at 25 0 C

. Results indicated that no major degradates were detected . M

- 4 (DIP), M

- 6

and M

- 11 were ≤3.8% of the applied.- Page 29 of 196

- Guideline Data Requirement Study MRID (Classification) Results

835.4200 Ana erobic Soil

Metabolism 49075001 (S) Observed DT 50 ’s as follows: 180 days (loamy sand), and >120 days in three additional foreign soils (sandy loam, a second loamy sand, and clay). For the loamy sand, the representative half

- life was 284 days. For the oth er soils, the representative half

- lives were at or above 1,245 days.

M

- 2, M

- 4 (DIP) and M

- 6 were less than 2.8% of the applied.

835.4300 Aerobic Aquatic

Metabolism 41841212 (A) t 1/2 = 1 year at 25 0 C in a clay sediment from MS Delta

. Study lasted for a short period of time of only 30 days.

835.4 4 00 Anaerobic Aquatic

Metabolism 41841211 (A) t 1/2 > 13 years in a clay sediment at 25 0 C

. Less than

1 .2 % of the applied was found as DIP

.

835.1230 Leac hing

Adsorption/ Desorption 42606627 (A)

40342943 (A)

41841213 (A)

42606626 (A) Parent K OC = 571 (sand); 592 (loam); 457 (clay loam); 628 (clay loam); 1,005 mL/g OC (loamy sand)

.

Parent K OC = 1

, 340 (sand); 883 (clay); 528 (sediment); 653 (clay loam); 1,150 mL/g OC (sandy loam)

. Sorption is correlated with organic carbon content. Mean

Parent K OC from 10 soils ( two studies ) is 780.7 mL/g OC ; moderately mobile according to EFED’s standard soil mobility classification (FAO 2000).

Aged soil (8 month s) shows that no major transformation products were observed and that no metabolites will be of

concern.

Degradate DIP K OC = 288 (sand); 293 (loam); 396 ( clay loam); and 317 mL/g OC (loamy sand)

.

835.6100 Terrestrial Field Dissipation 41837803 (U)

418 37804 (S)

43175809 (S)

45756603 (A)

45756602 (A) Unacceptable study

. Turf plot in CA. t 1/2 = 81 days. Flutolanil was detected through 24

- 30 inch soil depth. DIP was detected in the 0

- 3 inch depth at all intervals at up to 0.20 ppm (single

re plicate).

Peanuts field in FL. Biphasic pattern, t 1/2 = 44 days (0

- 121 days); t 1/2 = 225 days (121 days

– 18 months). DIP

was not detected below 8 cm. It was a maximum of 0.07 ppm at 14 days.

Turf field in CA (sandy loam). t 1/2 = 65.4 days. DIP

reac hed a maximum of only 0.10 ppm at 179 days and

was not detected below 15

- cm depth.

Bare field in FL , loam soil

. Taking into account all data points, the half

- life is 182 days. . t 1/2 = 26.7 days ( initial

half

- life ). DIP was at or below 0.02 ppm (LOQ=0.0 1 ppm).

835.6100 Long Term Field Dissipation 43175804 (S) Peanuts field in FL (loam)

. t 1/2 = 118 days (1 st year); 126 days (2 nd year); 123 days (3 rd year) . DIP was a maximum of 0.09 ppm at 1 month posttreatment #2.- Page 30 of 196

- Guideline Data Requirement Study MRID (Classification) Results

835.6 2 00 Aquatic Field Dissipation 42606618 (A)

43292603 (U) Rice paddies: CA s ediment t 1/2 = 303 days. The parent compound partitioned rapidly to the sediment (soil). Maximum residue in the water was 0.65 ppm and in the soil 0.57 ppm

. Maximum DIP was 0.01 ppm post second

treatme nt in water.

LA s ediment t 1/2 = 63 days . Maximum DIP was 0.04 ppm in water and 0.04 ppm in sediment.

Unacceptable study

.

860.1400 Accumulation in Irrigated Crops 42606615 (A) Rice paddies in AR (sandy loam) and LA (loam) . Parent

and DIP did no t accumu late in irrigated crops (cotton, soybean and turnips).

850.1730 Accumulation in

Fish 40342944 (A)

41841214 &

41841215 (A) Japanese carp ( Cypr inus carpio )

. BCF in whole fish = 13

- 26 L/Kg (in 0.1 ppm water)

BCF in whole fish = 9.3

- 24 L/Kg (in 0.01 pp m water)

. Bluegill sunfi sh ( Lepomis macrochirus ). BCF = 13 L/Kg (edible); 270 L/Kg (non

- edible); 150 L/Kg (whole fish) ; >95

- 99% of the TRR were eliminated after 3 days of depuration. The depuration half

- life was 0.3 days (and
the depuration rate constant was k 2 = 2.33 days

- 1



### .

850.1950 Accumulation in Aquatic Non

- target Organism 42641101 (A) Rice paddy in LA. Parent and degradate DIP were not

found in c rayfish , while the water contained up to 0.20 ppm flutolanil.

Non

guideline Soil Storage Stability 42 606616 (A) Stable at least 2 years in a sandy loam from FL.

850.6100 Analytical Method (Water) 48796401 (S) Reported LOQ = 0.1μg/L; LOD = 0.03 μg/L.

850.6100 Analytical Method (Soil) 48763101 &

4871400 1 (S) Reported LOQ = 0.01mg/kg; LOD = 0.003 mg/kg.

DIP = d esisopropyl flutolanil ; A=acceptable; S=Supplemental; U=unnaceptable



### The main route of dissipation of flutolanil is through slow aerobic soil metabolism (calculated

half

- lives of 190

- 320 days). In laboratory tests, flutolanil was resistant to hyd rolysis at all pHs tested and resistant to photolysis

, both in water (only 8% decline in 1 month) and on soils. Flutolanil also appears to be relatively persistent under anaerobic soil metabolism (representative

half

- lives of ≥284 days), and under aerobic and anaerobic aquatic metabolism ( with half

- lives of greater than one year and greater than 13 years, respectively)

. When flutolanil is applied to the field, it is expected to reach crop canopy (via foliar applications or translocated since it is a

syste mic pesticide), and the soil (through incorporation o n planted seeds, or foliar applications). Flutolanil can reach adjacent bodies of water through drift or runoff (dissolved or in eroded soil). Given the relatively high persistence of this chemical, an d despite its relatively high K OC 

### s, it may also have the potential to leach to subsurfaces. Flutolanil does not have major (>10%) degradation products identified in laboratory studies

. Desisopropyl flutolanil ( DIP ) and other minor product s w ere less than 4% of the applied in all the environmental fate studies. DIP appears to be more mobile than the parent compound.- Page 31 of 196

- 

### Field dissipation studies appear to indicate that in the field various dissipation processes may

occur. There are several terrestrial field dissipation studies and a long term study, which show

half

- lives of 27

- 126 days (excluding the second half

- life calculated for one of the studies for which a biphasic pattern was observed ) . Additionally, aquatic field dissipation studies were

conducted si nce this chemical can be used on rice. Such studies yielded also a wide range of

half

- lives of 63

- 303 and parent flutolanil remained mainly in the sediment. Flutolanil and its very minor degradate DIP may be transported to surface water through erosion o f soil particles containing bound flutolanil or dissolved in runoff water. Partition coefficients were not available for the other degradates, but would appear, based on their structure, to be as mobile as the parent.

Degradation and Metabolism

Mean [ 14 

### C] accountabil it y of all buffered test solutions ranged from 94.5 to 104 %. [ 14 

### C]

- flu tolani l did not hydrolyze in any of the three solutions during the 30 day test period. The range of parent recovered by TLC analysis was 98.1 to 99.5 %. Since no degrad ation was observed, no

half

- life calculations were made.

Aniline ring

- labeled [ 14 

### C]flutolanil was resistant to photodegradation (only ca. 8% decline in 30 days) in sterile aqueous buffer solution (pH 7.0) that was continuously irradiated with a xenon

arc lamp at 25 0 C for 30 days at a radiation intensity approximately one

- half that of natural sunlight. At 30 days posttreatment, flutolanil comprised 91.2 and 99.4% of the applied radioactivity in the irradiated and dark control solutions, respectively

. [ 14 

### C] Flutolan il did not degrade in a sandy loam soil that was irradiated using a borosilicate glass

- filtered xenon arc lamp or in the soil incubated in the dark for 30 days at 25 0 C.

The aerobic soil metabolism studies suggest that this is the main avenue of dissipatio n for this

chemical. Half

- lives were 190 days (clay loam); 320 days (loam); and 300 days (sandy loam) at

30 0 C. In another study, conducted at 25 0 C, the calculated half

- life was 21 7 days (sandy loam). Under anaerobic soil metabolism conditions, the obser ved DT 50 

### ’s were 180 days (loamy sand), and >120 days in three additional foreign soils (sandy loam, loamy sand 2, and clay). For the loamy sand, the representative half

- life was 284 days while for the other soils, the representative

half

- lives were at or above 1,245 days , indicating high persistence in the latter three soils. Under aerobic and anaerobic aquatic conditions, flutolanil was also persistent with calculated half

- lives of 1 year (aerobic) and >13 years (anaerobic) in clay sediments.

Transport and Mobility

Batch equilibrium studies for flutolanil

, and the transformation product desisopropyl flutolanil (DIP ) determined k d 

### values to range from 0.997

– 15.8

, and 0.5

– 11.3 mL/g , respectively. There

is a low propensity for flutolanil to leach base d on K OC 

### s ranging from 457

– 1

, 340 ml/g OC 

### and solubility of 6.53 ppm . For the parent compound sorption is correlated with organic carbon

content. The mean parent K OC 

### is 781 mL/g OC 

### (considered moderately mobile, according to FAO 2000)

. This is supported b y the results obtained in the field dissipation studies in which parent or

DIP were not detected below the 36

- inch sample depth. In field dissipation studies, the half

- lives

observed were shorter than in laboratory studies. However, a prospective ground water study has- Page 32 of 196

- 

### not been conducted nor requested to confirm whether or not it may leach. A prospective ground water study has been waived. Degradate DIP ’s K OC 

### ranged from 288 to 317 mL/g OC



### .

Field Studies

There are several acceptable and supplemental fi eld dissipation studies for flutolanil . These

include t errestrial field dissipation, long term terrestrial field dissipation (3 years), and aquatic field dissipation studies. The terrestrial field dissipation stud ies were conducted in California (two tur f studies) and Florida (two studies: peanuts and bareground). The turf field dissipation studies yielded half

- lives of 65.4 and 81 days. The peanut study yielded a half

- life of 44 days (and a secondary half

- life of 225 days, calculated from data covering the latter 6

- month period). Finally, the bareground study yielded a half

- life of 26.7 days. A long term terrestrial field dissipation study, in which flutolanil was applied during three consecutive years yielded the following half

- lives: 1 1 8 days (1 st 

### y ear); 126 days (2 nd 

### year); and 123 days (3 rd 

### year). In all these studies the monitored degradate desisopropyl flutolanil (DIP) was a minor component.

Additionally, aquatic field dissipation dissipation studies have been conducted for flutolanil, to

suppo rt the use of the chemical on rice. Two sites were used in the studies: California and Louisiana. The respective half

- lives were 303 and 63 days, in the sediments, where the chemical mostly partitioned.

Usually, in the field

, all dissipation pathways ma y take place . They may include degradation, metabolism, and offsite mobility ( e.g. , movement to subsurfaces, runoff in large rain events,

etc. ). H owever, t he terrestrial field dissipation studies suggest that in the field, processes other than degradatio n and metabolism may also be occurring

. Laboratory studies indicate that flutolanil is very persistent under most laboratory testing conditions, while the field dissipation

studies did not show moderate to high persistence. Since flutolanil is systemic, it is possible that

the chemical is also being translocated to the plants tissue (one exception, in which this is not a plausible explanation, is the bareground plot, which yielded a n initial half

- life of only 27 days

, and an overall half

- life or 182 days

, following a biphasic pattern ).

Bioconcentration in Fish

In one bioconcentration in fish study, using Japanese carp, the maximum BCF was 24 L/Kg. Meanwhile, in another study, t he maximum BCF for flutolanil was 270 L/Kg in non

- edible fish

, 13 L/Kg in edi ble tissue, and 150 L/Kg in whole fish

, as determined by total [ 1 4 

### C ]

. The test organism was bluegill sunfish. Depuration after termination of exposure was rapid with more

than 95

- 99% of the total residue recovered depurated in 3 days. These results woul d indicate a low propensity to bioconcentrate or bioaccumulate.

Degradates of Flutolanil

There were no transformation products exceeding 3.8% AR in any of the laboratory environmental fate studies. For example, i n laboratory aerobic soil metabolism stud ies, no major transformation products were identified. Three minor degradates were identified. 3'

- hydroxy

- 2

-- Page 33 of 196

- 

### trifluoromethyl

- benzanilide (DIP or M

- 4) was formed no more than

~ 3% of the applied. Two other degradates were formed in minor amounts (<1%). Th ese were 3'

- methoxy

- 2

- trifluoromethyl

- benzanilide (MDP or M

- 6 ) and 4'

- hydroxy

- 3

- methoxy

- 2

- trifluoromethyl

benzanilide (HMD or M

- 7 ). In l aboratory studies, 2

- [3

- [[2

- ( trifluoromethyl) benzoyl]amino] phenoxy ]propanoic acid (M

- 11), and α,α,α

- t rifluoro

- 4’

- hydr oxy

- 3’

- isopropoxy

- o

- toluanilide (M

2) were observed. Although DIP (or M

- 4) is not a major degradate found in any of the laboratory fate studies; nonetheless, it was monitored in all terrestrial and aquatic field dissipation studies. As expected, in the f ield it was also a minor component. For structures and chemical names of the transformation products of flutolanil, refer to Appendix K

.

Uncertainties in the Environmental Fate Database

The environmental fate database for flutolanil is substantially com plete, as evidenced by the presence of all environmental fate laboratory and field studies. It is noted that for the aquatic metabolism studies, besides the availability of only a single sediment for each study (usually two are available) , the duration of these studies was short compared to the calculated half

- lives. The aerobic aquatic metabolism study was conducted for a period of 1 month, compared to a half

- life of 1 year; meanwhile, the anaerobic aquatic metabolism study was conducted for 1 year,

comp ared to a half

- life of >13 years. Therefore, the results were extrapolated and are uncertain. Furthermore, the aerobic soil metabolism for three of four soils was conducted for 180 days, compared to half

- lives of ≥190 days (with the exception of one soil that was conducted for 1 year), which brings additional uncertainty to the results. It was also noted that the laboratory studies and the terrestrial field dissipation studies yielded substantially different half

- lives. In the field multiple routes of d issipation may be taking place. However, these differences constitute

uncertainties relative to the half

- lives used in modeling (derived from laboratory studies), compared to field studies.

3 .2.2

. Measures of Aquatic Exposure

3.2.2.1 Aquatic Exposure Modeling

Screening

- level EECs of flutolanil in surface water, pore water and sediment were generated based on maximum labeled single and seasonal use rates among many other parameters ( Table

3.5 )

. Given the moderately high sorption for flutolanil, and its likeliho od to occur in sediment, the Agency a lso consider ed the potential exposures resulting from benthic (pore water and sediment) concentrations (EECs). Pore water concentrations are commonly used to predict toxicity of non

- ionic substances in sediments and ch aracterize exposure to organisms that spend time in or near sediments (Di Toro et al. 1991; US EPA 2002). PRZM/EXAMS estimates 1

- in

10

- year peak and 21

- day mean EECs for pore water.

The scenarios listed in Table 3. 4 are those currently approved for Tier II modeling which most closely represent the labeled uses for flutolanil. Additionally, five rice scenarios modeled with the Pesticides in Flooded Applications Model (PFAM v1.00) are included in Table 3. 4

.- Page 34 of 196

- 

### Table 3. 4 . Flutolanil Uses, Scenarios, and App lication Information Used for Aquatic Exposure Inputs in Flutolanil Ecological Exposure Assessment

Run NO, Scenario

(bold font) / Uses

Represented M ethod of App. Drift/ App

Eff iciency Single

A pp R ate

kg

a.i./A

(lb a.i./A) Max

No. of Apps

at

Max

Rate Min.

In terval

Between

Apps (days) Day of

A pp (day

month) CAM IPSCND

Terrestrial Food Use Pa tterns

01 NC peanut /Peanuts In

- furrow at plant

, incorporation depth 1 ” = 2.54

cm 0.01/0.99 0.832 (0.742) 1 N/A 06

- 05 1 4 1

02 NC peanut /Peanuts Ground banded apps 40

- 60 d after planting 0.01/0.99 1.065 (0.950) 1 N/A 06

- 05 1 2 1

03 NC peanut /Peanuts Aerial 0.05/0.95 2.24 (2.00) 1 N/A 06

- 07 2 2 1

04 FL cabbage/ Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens Ground in a

narrow band

directed at transplanted plant

bases immediately after transplanting or

to the row at plant as an in

furrow directed spray; or, as soil drench at planting 0.01/0.99 0.865 (0.772) 1 N/A 16

- 10 3 2 1

05 CA cole crop / Same

as above Ground (same as above) 0.01/0.99 0.865 (0.772) 1 N/A 01

- 01 3 2 1

06 ID potato / Potatoes In furrow application to a

4

- 8 inch band prior to covering with soil, incorporation depth 2 ” = 5.08

cm 0.01/0.99 0.863 (0.77) 1 N/A 20

- 05 1 4 1

07 ME potato / Potatoes Same as above

5.08 cm 0.01/0.99 0.863 (0.77) 1 N/A 20

- 05 1 4 1

08 ID potato / Potatoes Seed piece

treatment 5.08

cm 0.0/1.0 0.403 (0.36) 1 N/A 20

- 05 1 4 1

09 ME potato / Potatoes Same as above

5.08 cm 0.0/1.0 0.403 (0.36) 1 N/A 20

- 05 1 4 1

10 CA cotton /Cotton Seed treatment, incorporation depth 3⁄4” = 1.91

cm 0.0/1.0 0.0254 (0.0227) 1 N/A 20

- 04 1 4 1

11 MS cotton / Cotton Seed treatment, incorporation depth 3⁄4” = 1.91

cm 0.0/1.0 0.0254 (0.0227) 1 N/A 20

- 04 1 4 1- Page 35 of 196

- Run NO, Scenario

(bold font) / Uses

Represented M ethod of App. Drift/ App

Eff iciency Single

A pp R ate

kg

a.i./A

(lb a.i./A) Max

No. of Apps

at

Max

Rate Min.

In terval

Between

Apps (days) Day of

A pp (day

month) CAM IPSCND

12 MS soybean / Soybeans Seed treatment, incorporation depth 1” = 2.54

cm 0.0/1.0 0.224 (0.200) 1 N/A 06

- 04 1 4 1

13 MN sugar

beet / Sugar Beets Seed treatment, incorporation depth 3⁄4” = 1.91

cm 0.0/1.0 0.0064 (0.0057) 1 N/A 06

- 05 1 4 1

Non

- food Use Patterns

14 FL turf/ Golf courses

, sod farms, spot fields,

residential

, institutional, municipal & commercial

areas Grou nd 0.01/0.99 9.64 (8.6) 2 14 15

- 03 4 2 1

15 PA turf / Same as

above Ground 0.01/0.99 9.64 (8.6) 2 14 15

- 03 4 2 1

16 FL turf/ Ornamental lawns and turf; recreation area lawns; residential lawns; Commercial/

Industrial lawns Ground 0.01/0.99 5.48 (4.89) 4 14 15

- 03 4 2 1

17 FL nursery / Nursery stock, ornamentals &

fruits (unspecified) Ground 0.01/0.99 11.0 (9.78) 4 10 01

- 03 5 2 1

18 NJ nursery / Same

as above Ground 0.01/0.99 11.0 (9.78) 4 10 01

- 03 5 2 1

19 FL nursery / Same

as above Soil drench 0.00/1.00 24.0 ( 2 1.5) 6 4 21 01

- 03 5 1 1

20 NJ nursery / Same

as above Soil drench 0.00/1.00 24.0 ( 2 1.5) 6 4 21 01

- 03 5 1 1

Aquatic Use Patterns

21 AR rice/ Rice Aerial 7

- 14 days after

panicle

differentiation N/A 1.10 (0.980) 1 N/A 14

- 06 N/A N/A

22 AR rice/ Rice Aerial (see above) N/A 0.549 (0.490) 2 10 14

- 06 N/A N/A

23 CA rice/ Rice Aerial (see above) N/A 1.10 (0.980) 1 N/A 0 4

- 07 N/A N/A

24 CA rice/ Rice Aerial (see above) N/A 0.549 (0.490) 2 10 0 4

- 07 N/A N/A

25 LA rice/ Rice Aerial (see above) N/A 1.10 (0.980) 1 N/A 06

- 06 N/A N/A

26 MS rice/ Rice Aerial (see above) N/A 1.10 (0.980) 1 N/A 24

- 06 N/A N/A

27 TX rice/ Rice Aerial (see above) N/A 1.10 (0.980) 1 N/A 31

- 05 N/A N/A

N/A=not applicable. CAM : 1= soil applied, default incorporation depth (4 cm), linearly decreasi ng with depth; 2= linear foliar based on crop canopy; 4= soil applied, user defined incorporation depth, uniform with depth. IPSCND : 1= surface applied.- Page 36 of 196

- Run NO, Scenario

(bold font) / Uses

Represented M ethod of App. Drift/ App

Eff iciency Single

A pp R ate

kg

a.i./A

(lb a.i./A) Max

No. of Apps

at

Max

Rate Min.

In terval

Between

Apps (days) Day of

A pp (day

month) CAM IPSCND

1 Assumed to occur 10 days prior to crop emergence. 2 Apply 50

- 70 days after planting.

3 Assumed to b e the same than crop emergence.

4 When conditions are favorable for disease or prior to the onset of high heat. This is interpreted to occur in the early Spri ng. 5 Applications were set to occur in the Spring. Scenarios are all year long.

6 The maximum a pplication rate for drench applications in containerized plants and plant beds is 42.9 lb a.i./A; however, BEAD supplied information indicating that in nursery settings, usually only 50% of the area is occupied by containers (for 6” and 8” containers) . Th erefore, the application rate was corrected for this factor and it is modeled at 21.5 lb a.i./A or 24.0 kg a.i./ha.



### Application parameters were chosen based on the likely method of application at the maximum application rate as indicated in the proposed label instructions. Chemical property and model input values for PRZM/EXAMS ( Table 3. 5 ) were chosen according to the current Input Parameter Guidance, (USEPA 2009b). Based on EFED guidance, aerial spray of liquid

formulations are assumed to have 95% effi ciency and 5% spray drift, and ground spray is expected to have 99% efficiency and 1% spray drift. Based on the registered uses for flu tolanil

, a variety of locations and PRZM crop scenarios were run to simulate national use of the pesticide.

Table 3

. 5

. Environmental Fate Data Used for Aquatic Exposure Inputs in Flu tolanil

E cological Exposure Assessment in PRZM/EXAMS 1

Parameter (units) Value(s) Sources Comments Output File Name Flutolanil

--- --- Chemical Name Flutolanil Label Label Application Rate ( K g a.i./ha) Refer to Table 3. 4 Highest single application rates according to the

label Label

Number of Applications Allowed Refer to Table 3. 4 Maximum allowed by the label, at the

maximum rate. Label

Interval between Applications (days) Refer to Table 3. 4 Minimum allowed by the

label. Label

Crop Names and Days of Application (day

month) Refer to Table 3. 4 Label Label

K OC (ml/g OC ) 780.7 40342943;

42606627 Sorption is correlated with organic carbon content. Represents the mean of the following 10 values: 457, 528, 571, 594, 628, 653, 883, 1,005, 1,150, and 1,340 mL/g OC- Page 37 of 196

- Parameter (units) Value(s) Sources Comments

Aerobic Soil Metabolism (days) t t t s

n input n

= + −

1 2 90 1

/ , ( )

= 308.3 40342941;

45756601 90 th percentile confidence bound on the

mean half

- life value: four values from two studies available: 190, 320, 300 days in one study, and 216.6 days in the other; mean = 256.65 days; std. dev. = 63.08 days, n = 2,

t 90,n

- 1 = 3.078 Method of Application Refer to Table 3. 4 Label Label
Buffer zone (ft) 0 Label Buffer restriction applies only to estuarine/ marine bodies of water (100 ft), for some of the crops. Application Efficiency (fraction) Refer to Table 3. 4 Label Current and proposed labels ; various methods of application. Spray Drift (fraction) Refer to Table 3. 4 Label Current and proposed labels ; various methods of applicati on. Solubility in Water (ppm) 6.53 41841202,

42606601 Solubility at 20oC.

Aerobic Aquatic Metabolism (days) 1

, 095 41841212 Value is multiplied by 3 since only one

value is available t 1/2 = 1 year at 25 0 C. Anaerobic Aquatic Metabolism (days) 0 (stable) 41841211 t 1/2 > 13 years in a clay sediment at 25 0 C; therefore, it is assumed to be stable. Hydrolysis at pH 7 0 (stable) 40342940 Relatively stable at a pH range of 5

- 9. Aqueous Photolysis (days) 0 (st able) 41841208;

41841209 Stable at pH 7.

Molecular Weight (g/mole) 323.3 Product Chemistry ---

Vapor Pressure (torr) 4.87 x 10
- 8 42606601 VP at 25oC Henry’s Law Constant (atm

- m 3 /mol) 3.17 x 10
- 9 42606601 Reviewer calculated from vapor pressure

and water solubility. Assume temperature

of 25 0 C

EXAMS Environment pond298.exv

--- Default for pond scenario.

Field Size EPA Pond

--- Runoff None

--- --- PRZM Scenario and

Metfile As suggested by the shell (PE5). PE shell

---

Incorporation Depth (cm) 0.0 Label Proposed labels 2

CAM, Chemical App lication Method Refer to Table 3. 4 Label CAM: 1= soil applied, default incorporation depth (4 cm), linearly decreasing with depth; 2= linear foliar based on crop canopy; 4= soil applied, user defined incorporation depth, uniform with depth
IPSCND, Conditi on for disposition of pesticide remaining on foliage after harvest) Refer to Table 3. 4 Label

---

FEXTRC, Foliar

extraction 0.5 Default value

---

PLDKRT, Decay rate on foliage 0 Default value

---- Page 38 of 196

- Parameter (units) Value(s) Sources Comments
PLVKRT,

Volatilization rate from foliage 0 Default value

- --

UPTKF, Uptake factor 0 Default value

--- 1 Data were selected according to EFED Guidance on Input Parameters v.2.1, dated 10/22/2009 and approved 11/10/2009 (USEPA 2009b).



### For the applications on rice, the Pesticides in Flooded Application Model (PF AM v1.00, January 23, 2013), was used. PFAM requires the entry of specific dates of applications, emergence, and flooding events. Using regional

- specific data provided in Table L

- 2 ( Appendix L ) , PFAM

required dates have been developed for the various mod eling scenarios as shown in Table 3. 6

. The midpoint of the planting dates in Table L

- 2 ( Appendix L ) was used in the modeling to estimate emergence dates. Emergence generally occurs 5

- 20 days after planting ( University of Arkansas, 2006 ), so, for this ass essment, emergence dates were assumed to occur 10 days after planting. The midpoint of the harvesting dates in Table L

- 2 ( Appendix L ) was used in the modeling to estimate the Days from Zero Height to Full Height input on PFAM’s Crop tab. It

was assumed t hat paddies are drained at least 21 days prior to harvesting ( Hill, et al. , 1997 ). The Days from Zero Height to Full Height were estimated as the difference between the release date (harvest date minus 21 days) and the emergence date. For flutolanil , all applications should

occur 7

- 14 days after panicle differentiation , according to the label directions , which is approximately 43 days after crop emergence ( Table 3.7

, Moldenhauer and Slaton, undated )

. A

four

- inch water column depth (0.1016 m) was modeled at all sites as indicated above

. For all scenarios, to simulate the release of water, flood water heights and weir heights were set to their respective values ( 0.1016 meters and 0.1270 meters, respectively, see Table 3. 8 under Flood

Tab ) for Event 1, but were set to 0 meters on the release day specified as Event 2. It was assumed that wet planting occurred and that flooding occurred 6 days before planting while release of water was set to occur approximately 21 days before harvesting.

Table 3. 6 . Crop

- spe cific dates used for PFAM m odeling (Crop tab)

State Planting 1 Emergence Date 2 Release Date 3 Harvesting 1

AR April 22 May 2 September 3 September 24

CA May 13 May 23 September 17 October 8

LA April 14 April 24 August 4 August 25

MS May 2 May 12 August 30 September 20

TX April 9 April 19 July 31 August 21 1 Midpoint from dates provided in Table 3. 4

. 2 Assumed to occur ~10 days after planting. 3 Assumed to occur ~21 days before harvesting.



### Table 3. 7 . Application rates for flutolanil and site

- specific in put dates used for PFAM modeling (Applications and Floods tabs), based in agronomic practices reported in crop

p rofiles

Use rate, Number of apps, water holding period, application method (wet or dry) State Date of App 1 Flood 2

(Event 1) Release 3

(Event 2) # days

between

events
0.980 lbs a.i./acre (1.10 kg a.i./ha), 1, not applicable, ground or aerial, assume wet AR Jun 14 Apr 15 Sept 3 141

CA Jul 4 May 7 Se pt 17 134- Page 39 of 196

- Use rate, Number of apps, water holding period, application method (wet or dry) State Date of App 1 Flood 2

(Event 1) Release 3

(Event 2) # days

between

events

Or , 0.490 lbs a.i./acre (0.549 kg a.i./ha), 2@14 days, not applicable, ground or aerial, assume

wet LA Jun 6 Apr 8 Aug 4 119

MS Jun 24 Apr 29 Aug 30 124

TX May 31 Apr 3 Jul 31 119

1 Set to occur 7

- 14 days after panicle differentiation or ~43 days after crop emergence. 2 Set to occur ~6 days before planting. 3 Set to occur ~21 days before harvesting.



### The remaining required input parameters used in PFAM were derived from chemical and fate properties and information provided in the crop profiles. These inputs are provided in Table 3. 8

. Inputs for the Crop tab, except for the zero height r eference which is the emergence date, and the Physical tab were left at the pre

- determined default levels ( see Appendix I )

. The Heat of Henry

was derived from the HENRYWIN v3.20 module of EPI Suite v4.1 ( further information about

the model at http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm , accessed October 25,

2013 ). F or further details about how to calculate the Heat of Henry , refer to Appendix J

.

Some of the input values in PFAM a re similar to those in PRZM/EXAMS . Despite the similarities, Tables 3. 5 and 3. 8 were not merged since there are also significant differences. For example, the input value of the aerobic soil metabolism half

- life is corrected for temperature at

25 0 C in PF AM while this is not done in PRZM/EXAMS. Further, input values which are persistent in PRZM/EXAMS (input value is 0), have a non

- zero input value in PFAM (input

1x10 8 

### days).

Table 3. 8

. Flutolanil

- specific PFAM inputs

Input Parameter Value Source Commen t

Chemical Tab

Water Column Half

- life (days) at 25 0 C 1095 41841212 Value is multiplied by 3 since only one value is

available t 1/2 = 1 year at 25 0 C. Benthic Compartment

Half

- Life (days) at 25 0 C 1x10 8 41841211 t 1/2 > 13 years in a clay sediment at 25 0 C; therefore, it is assumed to be stable.

Un

- flooded S oil Half

- life (days) at 25 0 C 435.1 40342941; 45756601 90 th percentile confidence bound on the mean

half

- life value: four values from two studies are available: 190, 320, 300 days in one study

conducted at 30 0 C; results corrected to 25 0 C as follows: 268.7, 452.5, and 424.2 days respectively (see USEPA 2010); additionally, 216.6 days in the other study, which was

conducted at 25 0 C ; mean = 340.5 days; std.

dev. = 115.55 days, n = 4 , t 90,n

- 1 = 3.078 Aqueous Near Surface

Half

- life (days) at 40 0

Latitude 1x10 8 41 841208; 41841209 No evidence of aqueous photolysis at pH 7

.

Hydrolysis Half

- life (days) 1x10 8 40342940 No evidence of degradation (pH range 5 to 9)

.- Page 40 of 196

- Input Parameter Value Source Commen t

Organic Carbon Partition Coefficient (mL/g OC ) (K OC ) 780.7 40342943; 42606627 Sorption is correlated with organic carbon content. Represents the mean of the following

10 values: 457, 528, 571, 594, 628, 653, 883, 1,005, 1,150, and 1,340 mL/g OC

Molecular Weight (g/mol) 323.3

--- ---

Vapor Pressure (torr) 4.87 x10
- 8 42606601

---

Solubility (mg/L) 6.53 4184120 2, 42606601

---

Heat of Henry (J/mol) 84872

--- Estimated using HENRYWIN program in

EPISuite ( Appendix J ). Henry Reference Temperature ( 0 C) 25

--- EPISuite.

Applications Tab Number of Applications See Table 3. 7

--- --- Application dates See Table 3. 7

--- --- Location Tab

Meteorological files AR (w13963)

CA (w23232)

LA (w13970)

MS (w03940)

TX (w13958) --- Meteorological data available in PE5 installation. Stations correspond to Little Rock, AR (w13963), Sacramento, CA (w23232), Baton Rouge, LA (w13970 ), Jackson, MS (w03940), and Austin, TX (w13958)

Latitude AR 35 0

CA 39 0

LA 31 0

MS 32 0

TX 30 0 -- Meteorological files.

Floods Tab

Number of Flood Events 2

--- First event is flooding; second event is release

of flood waters.

Date for Event 1 See Table 3. 7

Fill Level (m) , Event 1 0.1016

--- Permanent flood at 4”

Weir Level (m) , Event 1 0.1270

--- Assumed 1 inch clearance between top of weir

and water (5”)

. Min. Level (m), Event 1 0.1016

--- Keeps paddy full Number of Days, Event 2 See Table 3. 7

Fill Level (m) , Event 2 0

--- Simulate release of water

Weir Lev el (m) , Event 2 0

--- Simulate release of water
Min. Level (m), Event 2 0

--- Simulate release of water

Turn Over (1/day), Events

1 and 2 0

--- Turnover is used for those systems that use a continuous flow through the system and are

maintained at a set d epth . Set to 0. Crop Tab

Zero Height Reference AR: 05/02

CA: 05/23

LA: 04/24

MS: 05/12

TX: 04/19 --- Emergence date, assumed to occur 10 days after planting. See Table 3. 7 for dates.- Page 41 of 196

- Input Parameter Value Source Commen t

Days from Zero Height to Full Height AR: 124

CA: 118

LA: 102

MS: 111

T X: 103 --- Number of days from emergence to maturation. Maturation expected to occur 21 days prior to harvesting. See Table 3. 7 for dates.

Days from Zero Height to

Removal AR: 145

CA: 139

LA: 123

MS: 132

TX: 124 --- Number of days from emergence to harves t.
See Table 3. 7 for dates.

Maximum Fractional Areal Coverage 1.0

--- Conservative assumption

Physical Tab

Mass transfer coefficient (m/s) 1x10
- 8

--- PFAM default value

Leakage (m/d) 0

--- PFAM default value

Reference depth (m) 0.1270

--- Set to same depth as weir height, per PFAM guidance. Benthic depth (m) 0.05

--- PFAM default value Benthic porosity 0.50

--- PFAM default value Dry bulk density (g/cm 3 ) 1.35

--- PFAM default value

F OC Water Column on SS 0.04

--- PFAM default value

F OC benthic 0.0 1

--- PFAM default value SS (mg/L) 30

--- PFAM default value

Water column DOC (mg/L) 5.0

--- PFAM default value

Chlorophyll CHL (mg/L) 0.005

--- PFAM default value

Dfac 1.19

--- PFAM default value
Q10 2

--- PFAM default value Output Tab

Route efflue nt N/A

--- Not applicable to ecological risk assessment. Area of Application (m 2 ) N/A

--- Not applicable to ecological risk assessment. Area of Surrounding Watershed (m 2 ) N/A

--- Not applicable to ecological risk assessment.

Curve Number of Surrounding Watershed N/A

--- Not applicable to ecological risk assessment.

Base flow (m 3 /s) N/A

--- Not applicable to ecological risk assessment. Width of mixing cell (m) N/A

--- Not applicable to ecological risk assessment. Depth of mixing cell (m) N/A

--- Not ap plicable to ecological risk assessment. Length of mixing cell (m) N/A

--- Not applicable to ecological risk assessment. 1 Data were selected according to EFED Guidance on Input Parameters v.2.1, dated 10/22/2009 and approved

11/10/2009.



### The EECs listed in Table 3. 9 reflect 1

- in

- 10 year surface water, porewater and sediment concentrations based on maximum application rates for labeled uses of flu tolanil

.

Additionally, the 90 th 

### percentile peak (acute), 21

- day and 60

- day averages (chronic)

concentration s for the Arkansas, California, Louisiana, Mississippi, and Texas PFAM runs are provided in Table 3. 9 . The 90 th 

### percentile concentration was selected to reflect the 1

- in

- 10 year peak or chronic concentration, similar to the method used in EFED’s modeling using PRZM/- Page 42 of 196

- 

### EXAMS. The concentrations are obtained from the Processed Output files generated by PFAM. This output file provides a time series of water concentration (while flooded), and benthic pore water concentrations. This file was postprocessed by m eans of an Excel worksheet. For the water column concentrations, the time during which the column was dry was excluded from the analysis, as these values are indicative of times when a rice paddy is not present. For the AR and CA scenarios, in addition t o the single application modeled , which is the most conservative circumstance; two applications were also modeled, which are allowed in the label instructions.

EECs were similar for all the rice scenarios and decreased when the applications were divided b y two (as expected).- Page 43 of 196

- 

### Table 3. 9 . Surface Water , Pore Water and Sediment Estimated Environmental Concentrations (EECs) for Labeled Uses of

Flu tolanil 1

Scenario (bold font)/ Crops/Uses Represented App

. Method App

. Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps

. App

. Interval

(days) Water Column Pore Water Sediment 2

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc )

01 NC peanu t /

Peanuts In

- furrow at plant 0.742 06

- 05 1 N/A 30.1 29.8 29.4 28.8 28.8 22800 22800

02 NC peanut /

Peanuts Ground

banded

apps 0.950 06

- 05 1 N/A 41.8 41.3 40.7 39.9 39.9 31500 31500

03 NC peanut /

Peanuts Aerial 2.00 06

- 07 1 N/A 129 126 124 122 122 96400 9 6400

04 FL cabbage/
Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens Ground in

a narrow

band 0.772 16

- 10 1 N/A 36.7 36.0 35.8 34.4 34.0 27200 26900

05 CA cole

crop / Same as

above Ground in

a narrow

band 0.772 01

- 01 1 N/A 71.4 70.6 70.3 6 7.8 67.8 53600 53600

06 ID potato /

Potatoes In furrow band app 0.77 20

- 05 1 N/A 8.27 8.22 8.18 8.03 8.03 6350 6350

07 ME potato /

Potatoes In furrow band app 0.77 20

- 05 1 N/A 30.1 30.0 29.8 29.4 29.4 23200 23200

08 ID potato /

Potatoes Seed piece

treatmen t 0.36 20

- 05 1 N/A 2.33 2.32 2.31 2.24 2.24 1770 1770

09 ME potato

/ Potatoes Seed piece

treatment 0.36 20

- 05 1 N/A 12.5 12.4 12.4 12.3 12.3 9720 9720

10 CA cotton /

Cotton Seed

treatment 0.0227 20

- 04 1 N/A 0.158 0.153 0.147 0.140 0.140 111 111

11 MS cott on /

Cotton Seed

treatment 0.0227 20

- 04 1 N/A 2.67 2.63 2.60 2.47 2.47 1950 1950

12 MS soybean / Soybeans Seed

treatment 0.200 06

- 04 1 N/A 20.0 19.7 19.0 18.8 18.7 14900 14900

13 MN sugar

beet / Sugar Beets Seed

treatment 0.0057 06

- 05 1 N/A 0.289 0.287 0.285 0.279 0.279 220 220- Page 44 of 196

- Scenario (bold font)/ Crops/Uses Represented App

. Method App

. Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps

. App

. Interval

(days) Water Column Pore Water Sediment 2

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc )

14 FL turf/ Golf

courses
, sod farms, spot fields,

residential

, institutional, municipal &

commercial areas Ground 8.6 15

- 03 2 14 170 168 162 157 157 124000 124000

15 PA turf / Same

as above Ground 8.6 15

- 03 2 14 217 214 210 204 204 161 000 161000

16 FL turf/

Ornamental lawns and turf; recreation area lawns; residential lawns;

Commercial/

Industrial lawns Ground 4.89 15

- 03 4 14 178 177 173 169 169 134000 134000

17 FL nursery / Nursery stock,

ornamentals & fruits (unspecified) Ground 9.78 01

- 03 4 10 2300 2240 2170 2010 2010 1590000 1590000

18 NJ nursery /

Same as above Ground 9.78 01

- 03 4 10 2170 2160 2140 2090 2090 1650000 1650000

19 FL nursery /

Same as above Soil

drench 21.5 01

- 03 4 21 4690 4610 4530 4280 4280 3380000 3380000

20 NJ nur sery /

Same as above Soil

drench 21.5 01

- 03 4 21 3700 3650 3590 3480 3480 2750000 2750000

21 AR rice/ Rice Aerial 0.980 14

- 06 1 N/A 1120 600 382 247 246 202000 201000

22 AR rice/ Rice Aerial 0.490 14

- 06 2 10 829 522 366 245 245 201000 201000

23 CA rice/ Rice Aerial 0.980 0 4

- 07 1 N/A 1161 649 431 295 295 241000 241000

24 CA rice/ Rice Aerial 0.490 04

- 07 2 10 870 569 416 294 294 241000 241000

25 LA rice/ Rice Aerial 0.980 0 6

- 06 1 N/A 1100 578 350 225 224 184000 183000

26 MS rice/ Rice Aerial 0.980 24

- 06 1 N/A 1100 588 365 233 230 192000 188000

27 TX rice/ Rice Aerial 0.980 31

- 05 1 N/A 1130 611 393 263 262 215000 214000

1 EECs were rounded to three significant figures , with a few exceptions

. 2 Sediment EECs are organic carbon normalized values.- Page 45 of 196

- 

### 3.2.2.2. Monitoring Data

There is no readily available monitoring data for this chemical. Flutolanil was not found in the USGS National Water Quality Assessment Data Warehouse (NAWQA), when verified by constituent finder (at http://infotrek.er.usgs.gov/apex/f?p=NAWQA:HOME:0 , accessed 08/14/2013). An open literature article was found (Baris et al. , 2010). Despite that this comprehensive review indicates that this chemical has been monitored in surfa ce and groundwater, associated with the use of the chemical on golf courses, individual results were not reported.

3.2.3. Measures of Terrestrial Exposure

3.2.3.1. Ingestion of Terrestrial Food Items by Birds and Mammals

Terrestrial wildlife exposure e stimates are typically calculated for birds and mammals by

e mphasizing the dietary exposure route of uptake of pesticide active ingredients. These exposures are considered to be surrogates for exposures to terrestrial

- phase amphibians and reptiles. For e xposure s to terrestrial organisms

, such as birds and mammals, pesticide residues on food items are estimated based on the assumption that organisms are exposed to pesticide

residues as a function of the pesticide use pattern

.

T

- REX (v. 1. 5

. 2 ) is used to calculate dietary and dose

- based EECs of flutolanil residues on food

items for mammals and birds generated by spray applications for the labeled uses . Input values for deriving EECs using T

- REX are located in Table 3. for foliar uses and Table 3.1 1 for seed

treatment uses. Upper

- bound Kenaga nomogram values are used to derive EECs for flutolanil exposures to terrestrial mammals and birds based on a 1

- year time period. Consideration is given to different types of feeding strategies for mammals, including herbivores, insectivores and granivores. D ose

- based exposures are estimated for three weight classes of birds (20 g , 100 g
, and 1000 g) and three weight classes of mammals (15 g , 35 g , and 1000 g). Terrestrial EE Cs for

foliar spray uses and seed treatment uses of flutolanil are provided in Tables 3.1 2 , 3.1 3

, and

3.1 4 , and 3.1 5

.

Table 3. 1 0 . Input Parameters for Deriving Screening

- Level Terrestrial EECs for Labeled

Uses of Flutolanil ( T

- REX v. 1.5 .2 )

.

Uses Represe nted Single App

Rate
(lb a.i./A) Max No. of Apps

at Max Rate Min. Interval Between Apps (days)

Food crops Brassica (Cole) leafy vegetables, and turnip greens 0.77 2 1 N/A

Peanuts 0.74 1 N/A

Peanuts 0.95 1 N/A

Peanuts 2 1 N/A

Peanuts 0.95 2 21

Peanuts 1 2 30

Peanuts 0.48 4 10

Peanuts 0.5 4 10

Potatoes 0.77 1 N/A- Page 46 of 196

- Uses Represe nted Single App

Rate
(lb a.i./A) Max No. of Apps

at Max Rate Min. Interval Between Apps (days)

Rice 0.98 1 N/A

Rice 0.49 2 10

Turf uses
Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and commercial areas 8.6 2 14

Golf course greens, tees, and a prons 8.56 5 14
Golf course fairways (all states but FL) 9.77 1 N/A
Golf course fairways (only in FL) 4.88 1 N/A

Ornamental lawns and turf; recreation area lawns,

residential lawns 4.89 4 14

Commercial and industrial lawns 5.94 4 14 Nursery stock, or namentals, and fruit s (unspecified) uses Nursery stock, ornamentals & fruits (unspecified) 9.78 4 10

Nursery stock, ornamentals & fruits (unspecified) 2.1 2 14 N/A = not applicable



### Table 3. 1 1 . Input Parameters for Deriving Screening

- Level Terrestrial EECs for Seed

Treatment Uses of Flutolanil (T

- REX v. 1.5 .2 ).

Uses Represented Single App

Rate (fl oz/100 lb

seeds Max No. of Apps

at Max Rate Min. Interval Between Apps (days) Crop Seeding Rate in

lbs/acre (within T

- REX)

Potato 1 1 N/A 6970 (seed pieces)

Cotton 4 1 N/A 18.9 Soybean 4 1 N/A 167 Sugarbeet 4 1 N/A 4.8 N/A = not applicable



### Differences in exposures between ground and aerial applications cannot be assessed with the

current T

- REX model ; exposure and risk estimates from the T

- REX model are co nsidered relevant to both application scenarios. Other u ncertainties in the terrestrial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces.

EFED assumes a default 35

- day foliar dissipation ha lf life, based on the work of Willis and McDowell (1987) when data are absent or are insufficient

. A further uncertainty with the model is the inability to model systemic chemicals like flutolanil as T

- REX only simulates residues directly on food items.

Some use patterns of flutolanil employ a soil drench method. T

- REX is not able to simulate a soil drench scenario as the resultant EECs and RQs would assume that the entire application rate would be sprayed o n terrestrial food items as the y are for conve ntional aerial and ground applications. For soil drench, even though the label does not specifically preclude application on foliage, it is expected to take place on the root ball of the crop. Since flutolanil is systemic, food items are likely to be con taminated with the chemical even if it is not directly applied , when it is translocated across plant tissue . However, the levels or concentrations of flutolanil in food items are uncertain for the soil drench applications.- Page 47 of 196

- 

### Additionally, some uses of flut olanil are seed treatment uses that require a planting depth of 3⁄4

- 1 inch depth on the label. T

- REX is not able to simulate this and instead assumes that the treated

seeds are broadcast across the field in an unincorporated manner

. An example output fro m the

T

- REX model is provided in Appendix B

.- Page 48 of 196

- 

### Table 3. 1 2

. Screening

- level Dose

- based EECs (mg/kg bw) as Food Residues for Birds , Reptiles, and Terrestrial

- Phase Amphibians from Labeled Uses of Flutolanil (T

- REX v. 1.5

. 2 )

.

Primary Feeding Strategy  Herbi vores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Me

d Larg

e

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 1 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 211 96.7 119 13.2 120 55.2 67.7 7.52 53.9 24.7 30.3 3.37 82.7 47.1 21.1 2.93 1.67 0.75

Peanuts (0.95 lb a.i/A) 2 60 119 146 16.2 148 67. 9 83. 3 9.25 66. 3 30. 4 37. 3 4.14 10 2 58.0 26.0 3.61 2.06 0.92 Peanuts (0.475 lb a.i/ A, 4X) 395 181 222 24.7 225 103 127 14.1 101 46.3 56.8 6.31 155 88.3 39.5 5.49 3.13 1.40

Peanuts (0 .95 lb a.i, 2X) 43 1 198 242 26.9 246 113 138 15.4 110 50.4 61.9 6.88 169 96.3 43.1 5.99 3.41 1.53

Peanuts (2 lbs a.i/A) 54 7 251 30 8 34.2 312 143 175 19.5 140 64.0 78.5 8.72 214. 122 54.7 7.59 4.33 1.94

Peanuts (1 lb a.i/A, 2X) 424 194 239 26.5 242 111 13 6 15.1 108 49.6 60.9 6.77 166 94.8 42.4 5.89 3.36 1.50

Peanuts (0.5 lbs a.i/A, 4x) 416 191 234 26.0 237 109 134 14.8 106 48.7 59.8 6.64 163 93.0 41.6 5.78 3.30 1.48

Peanuts (0.74 lbs a.i/A, 1X) 20 3 93.0 114 12.7 116 53.0 65.1 7.23 51.8 23.7 29.1 3.24 79. 4 45.3 20.3 2.82 1.61 0.72

Potatoes 210 96.5 118 13.2 120 55.0 67.5 7.50 53.7 24.6 30.2 3.36 82.4 47.0 21.0 2.92 1.67 0.75

Rice (0.980 lb a.i/A,

1X 26 8 12 3 15 1 16.7 15 3 70.0 8 6.0 9.55 68. 4 31.3 38. 5 4.27 10 5 59.8 26. 8 3.72 2.12 0.95

Rice (0.490 lbs a.i /A, 2X) 24 4 11 2 137 15.2 13 9 63.7 78.2 8.69 62.2 28.5 35.0 3.89 95. 5 54. 5 24. 4 3. 4 1.93 0.86

Turf Uses- Page 49 of 196

- Primary Feeding Strategy  Herbi vores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Me

d Larg

e

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 1 

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 4132 1894 2324 258 2356 1080 1325 147 1055 484 593 65.9 1618 923 413 57.34 32.7 14.7

Golf course greens, tees, and aprons 7247 3322 4076 453 4133 1894 2325 258 1850 848 1041 116 2838 1619 725 101 57.4 25.7

Golf course fairways (all states but FL) 2670 1224 1502 167 1523 698 857 95.2 682 312 384 42.6 1046 596 267 37.1 21.2 9.47

Golf course fairways (only in FL) 1334 611 750 83.4 761 349 428 47.5 341 156 192 21.3 522 298 133 18.5 10.6 4.73

Ornamental lawns and turf; recreation area lawns, residential

lawns 3699 1695 2080 231 2109 967 1187 132 944 433 531 59.0 1449 826 370 51.4 29.3 13.1

Commercial and

industrial lawns 4493 2059 2528 281 2562 1174 1441 160 1147 526 645 71.7 1760 1004 449 62.4 35.6 15.9

Nursery stock, ornamentals & fruit s (unspecified) uses
Nursery stock,

ornamentals & fruits (unspeci fied) (9.78

lbs a.i/A, 4X) 814 1 3731 4579 509 4642 2128 2611 290 2078 953 1169 130 3189 1818 814 113 64.5 28.9

Nursery stock,

ornamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) 1009 462 568 63.1 575 264 324 36.0 258 118 145 16.1 395 225 101 14.0 7.99 3.58

Values are in mg a.i/kg

- bw

. 1 Represent a proposed use, all other uses are currently registered.- Page 50 of 196

- 

### Table 3. 1 3 . Screening

- level Dose

- based EECs (mg/kg bw) as Food Residues for Mammals from Labeled Uses of Flutolanil (T

REX v. 1.5 .2 ).
Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 1 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 177 81.0 99.4 11.0 122 56.0 68.7 7.63 28.3 13.0 15 .92 1.77 69.2 47.8 11.1 2.45 1.70 0.39

Peanuts (0.95 lb a.i/A) 217 99.6 122 13.6 150 68.9 84.5 9.39 34.8 16.0 19.6 2.18 85.1 58.8 13.6 3.02 2.09 0.48

Peanuts (0.475 lb a.i/ A, 4X) 331 152 186 20.7 229 105 129 14.3 53.0 24.3 29.8 3.31 130 89.6 20.8 4.60 3.18 0.74

Peanuts (0.95 lb a.i, 2X) 36 1 165 203 22.6 250 114 140 15.6 57.8 26.5 32.5 3.61 141 97.7 2 2.6 5.01 3.46 0.80

Peanuts (2 lbs a.i/A) 45 8 210 257 28.6 316 145 178 19.8 73.3 33.6 41.2 4.58 179 124 28.7 6.36 4.39 1.02

Peanuts (1 lb a.i/A, 2X) 355 1 63 200 22.2 245 113 138 15.3 56.9 26.1 32.0 3.56 139 96.1 22.3 4.93 3.41 0.79

Peanuts (0.5 lbs a.i/A, 4x) 348 160 196 21.8 241 110 135 15.1 55.8 25.6 31.4 3.49 136 94.3 21.9 4.84 3.34 0.78

Peanuts (0.74 lbs a.i/A, 1X) 1 70 77.8 95.5 10.6 117 53.8 66.0 7.3 3 27 .2 12.5 15.3 1.70 66.5 46.0 10.7 2.36 1.63 0.38

Potatoes 176 80. 8 99.1 11.0 12 2 55.8 68.5 7.61 28.2 12.9 15. 9 1.76 69.0 47. 7 11. 1 2.45 1.69 0.39

Rice (0.98 lbs a.i/A, 1X) 224 103 126 14.0 155 71.0 87.2 9.69 35.9 16.5 20.2 2.25 87.8 60.7 14.1 3.11 2. 15 0.50

Rice (0.490 lbs a.i/A, 2X) 204 93. 6 11 5 12. 8 141 64. 7 79. 4 8.82 32.7 1 5.0 18.4 2.04 79.9 55. 3 12.8 2.83 1.96 0.45

Turf Uses- Page 51 of 196

- Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

.

Use(s) 1 

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 3459 1585 1946 21 6 2391 1096 1345 149 554 254 312 34.6 1355 936 217 48.0 33.2 7.70

Golf course greens, tees, and aprons 6067 2781 3413 379 4193 1922 2359 262 972 446 547 60.8 2376 1642 381 84.3 58.2 13.5

Golf course fairways all states but FL) 2236 1025 1258 140 1545 708 869 96.6 358 164 202 22.4 876 605 140 31.1 21.5 4.98

Golf course fairways (only in FL) 1117 512 628 69.8 772 354 434 48.2 179 82.0 101 11.2 437 302 70.1 15.5 10.7 2.49

Ornamental lawns and turf; recreation area lawns,

residential lawns 309 7 1419 174 2 19 4 2140 98 1 120 4 133 496 227 279 31.0 121 3 838. 194 43.0 29.7 6.89

Commercial and

industrial lawns 376 2 1724 211 6 235 2 600 119 2 1462 162 60 3 276 339 37. 7 1473 1018 236 52.2 36.1 8.37

Nursery stock, ornamentals & fruit s (unspecified) uses
Nursery stock,

o rnamentals &

fruits (unspecified) (9.78 l bs a.i/A, 4X) 6815 312 4 383 42 6 4710 215 9 2649 294 1092 50 1 614 68. 3 2669 184 5 42 8 94. 7 65.4 15. 2

Nursery stock,

ornamentals &

fruits (unspecified) (2.1 l bs a.i/A, 2X) 84 5 387 475 52. 8 58 4 26 8 328 36. 5 135 62.0 76. 1 8.46 33 1 22 9 53.0 11.7 8.11 1.88

Values are in mg a.i/ kg

- bw

. 1 Represents a proposed use, all other uses are currently registered.- Page 52 of 196

- 

### Table 3. 1 4 . Screening

- level Dietary

- based EECs (mg/kg diet) as Food Residues for Birds, Reptiles, Terrestrial

- phase Amphib ians, and Mammals from Labeled Uses of Flutolanil (T

REX v. 1.5

. 2 ).
Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 185 84.9 104 11.6 72.8

Peanuts (0.95 lb a.i/A) 228 105 128 14.3 89.3

Peanuts (0.475 lb a.i/ A, 4X) 347 159 195 21.7 136

Peanuts (0.95 lb a.i, 2X) 378 173 213 23.7 148

Peanuts (2 lbs a. i/A) 480 220 270 30.0 188

Peanuts (1 lb a.i/A, 2X) 372 171 210 23.3 146

Peanuts (0.5 lbs a.i/A, 4x) 365 168 206 22.8 14 3

Peanuts (0.74 lbs a.i/A, 1X) 178 81.6 100 11.1 69.8

Potatoes 18 5 84.7 10 4 11. 6 72. 4

Rice (0.980 lbs a.i/A, 1X) 235 108 132 14.7 9 2.1

Rice (0.490 lbs a.i/A, 2X) 214 98.1 120 13. 4 83.8

Turf Uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 3628 1663 2041 227 1421

Golf course greens, tees, and aprons 6363 2916 3579 398 2492

Golf course fairways (all states but FL) 2345 1075 1319 147 918

Golf course fairways (only in FL) 1171 537 659 73.2 459
Ornamental lawns and turf; recreation area lawns, residential lawns 3248 1489 1827 203 1272

Commercial and industrial lawns 3945 18 08 2219 247 1545

Nursery stock, ornamentals & fruit s (unspecified) uses
Nursery stock, ornamentals & fruit s (unspecified) (9.78 lbs a.i/A, 4X) 7148 3276 4021 447 2800

Nursery stock, ornamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) 88 6 406 498 55. 4 347 Values are in ppm (mg a.i/kg

- diet)

.- Page 53 of 196

- 

### Table 3.1 5

. Screening

- level EECs (mg/kg bw

- day ) resulting from Seed Treatment Applications of Flutolanil (T

- REX v. 1.5. 2 ).

Use Rate (fl

oz/100

lb seeds) Maximum application

rate (lbs

a.i/A) Maximum

Seed Appli cation

Rate (mg a.i/kg seed) Avian Nagy Dose (mg a.i/kg

- bw/day) Avian Nagy Dose (mg a.i/kg

- bw/day)

Available a.i (mg a.i sq.ft)SmallMediumLargeSmallMediumLarge

Cotton 4 0.01 475 120 68.6 30.7 101 70.0 16.1 0.09 Soybean 4 0.08 475 120 68.6 30. 7 101 70.0 16.1 0.83 Sugarbeet 4 0.002 475 120 68.6 30.7 101 70.0 16.1 0.02

Potato 1 (per

100 lb

seed pieces) 0.07 9.76 2.47 1.41 0.63 2.07 1.43 0.33 0.71



### 3.2.3.2. Runoff and Spray Drift to Terrestrial and Semi

- Aquatic Plants

Exposure of non

- target t errestrial and semi

- aquatic (wetland) plant species is estimated using the TerrPlant (v

. 1.2.2 ) model. Loading via spray drift to dry, non

- target, adjacent areas is assumed

to occur from one acre of treated land to one acre of the non

- target area. Runoff is also expected

to be a source of pesticide loading to non

- target areas. TerrPlant calculates EECs as a function

of application rate, solubility

, and default assumptions regarding spray drift. The default spray drift assumptions are 1% of the applicati on rate for ground spray applications and 5% for aerial spray applications (USEPA 2006b)

. The EECs for terrestrial and semi

- aquatic plants for a single application of flutolanil at the maximum label ed rates for representative uses are presented in

Table 3 .1 6 (see example output in Appendix 3Appendix ).

Table 3. 1 6 . EECs for Terrestrial and Semi

- Aquatic Plants Near Flutolanil Use Areas (TerrPlant v. 1.2.2).

Crop Single Max. Application

Rate (lbs a

. i

. /A) EECs (lbs a i/A)

Runoff to dry areas Runoff to

semi

aquatic

areas Spray

drift Total for dry

areas Total for

semi

aquatic

areas
Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 0.772 0.008 0.077 0.008 0.015 0.085

Peanuts (ground) 0.475 0.005 0.04 8 0.005 0.010 0.052

Peanuts (aerial or chemigation) 0.475 0.005 0.048 0.024 0.029 0.071

Peanuts (ground) 0.5 0.005 0.05 0.005 0.01 0.055

Peanuts (aerial or chemigation) 0.5 0.005 0.05 0.025 0.03 0.075- Page 54 of 196

- Crop Single Max. Application

Rate (lbs a

. i

. /A) EECs (lbs a i/A)

Runoff to dry areas Runoff to

semi

aquatic

areas Spray

drift Total for dry

areas Total for

semi

aquatic

areas

Peanuts 1 0.742 0.007 0.074 0.007 0.015 0.082

Peanu ts (ground) 0.95 0.010 0.095 0.010 0.019 0.105

Peanuts (aerial or chemigation) 0.95 0.010 0.095 0.048 0.057 0.143

Peanuts (ground) 1.0 0.01 0.1 0.01 0.02 0.11

Peanuts (aerial or chemigation) 1.0 0.01 0.1 0.05 0.06 0.15

Peanuts (ground) 2.0 0.02 0.2 0.0 2 0.04 0.22

Peanuts (aerial or chemigation) 2.0 0.02 0.2 0.1 0.12 0.3

Potatoes 2 0.77 0.004 0.039 0.008 0.012 0.046

Rice (aerial) 0.980 0.010 0.098 0.049 0.059 0.147

Rice (aerial) 0.490 0.005 0.049 0.025 0.029 0.074

Rice (ground) 0.980 0.010 0.098 0.01 0 0.020 0.108

Rice (ground) 0.490 0.005 0.049 0.005 0.010 0.054

Turf uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 8.6 0.086 0.86 0.43 0.516 1.29

Golf course greens, tees, and

aprons 8.56 0 .086 0.856 0.428 0.514 1.284

Golf course fairways (except FL) 9.77 0.098 0.977 0.489 0.586 1.466

Golf course fairways (FL) 4.88 0.049 0.488 0.244 0.293 0.732

Ornamental lawns and turf; recreation area lawns,

residential lawns 4.94 0.049 0.494 0.247 0.29 6 0.741

Commercial and industrial

lawns 5.94 0.059 0.594 0.059 0.119 0.653

Nursery stock, ornamentals & fruit s (unspecified) uses

Nursery stock, ornamentals &

fruits (unspecified) 9.78 0.098 0.978 0.489 0.587 1.467

Nursery stock, ornamentals &

fruits ( unspecified) 2.1 0.021 0.210 0.105 0.126 0.315

NA Not applicable.

1 1

- inch incorporation

2 2

- inch incorporation



### 3.2.3.3. Terrestrial Organism Exposure to Residues in Aquatic Food Items (KABAM)

The KABAM model (K OW 

### (based) Aquatic BioAccumulation Model) version 1.0 was used to evaluate the potential exposure and risk of direct effects to birds and mammals via- Page 55 of 196

- 

### bioaccumulation and biomagnification in aquatic food webs. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides i n freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. The bioaccumulation portion of KABAM is based upon work by Arnot and Gobas (2004) who parameterized a bioaccumulation mo del based on PCBs and some pesticides ( e.g ., lindane, DDT) in freshwater aquatic ecosystems (Arnot and Gobas, 2004) . KABAM relies on a

chemical's octanol

- water partition coefficient (K OW 

### ) to estimate uptake and elimination constants through respiration an d diet of organisms in different trophic levels. Pesticide tissue residues are calculated for different levels of an aquatic food web. The model then uses pesticide tissue concentrations in aquatic animals to estimate dose

- and dietary

- based exposures an d associated risks to mammals and birds (surrogate for amphibians and reptiles) consuming aquatic organisms. Seven different trophic levels including phytoplankton, zooplankton, benthic invertebrates, filter feeders, small

- sized (juvenile) forage fish, me dium

- sized forage fish, and larger piscivorous fish, are used to represent an aquatic food web. Importantly, chemical metabolism by biota is assumed to be zero in KABAM unless evidence indicates such metabolism is likely to affect the model predictions su bstantially. Example output from the

bioaccumulation model is provided in Appendix H

.

By default, KABAM assumes zero for the metabolism rate constant (Km). For flutolanil , direct estimates of the metabolism rate constant (k

m 

### ) were not available. A Km value to override the “0,” assumption within KABAM can be used as a refinement as data from two studies on

bioconcentration in fish allow the estimation of a Km value. The calculation is described in the next paragraph. The use of this adjusted Km value results in a lower total concentration across small, medium, and large fish that may serve as flutolanil contaminated potential food items for birds and mammals, and therefore lower resultant RQs. As there are no studies available for the

bioconcentrati on of flutolanil in other aquatic trophic levels such as phytoplankton and aquatic invertebrates, the use of this adjusted Km value does not impact the RQs of birds and mammals that feed exclusively on these non

- fish food items.

Two studies on bioconcentr ation in fish for flutolanil indicated that the potential

bioconcentration factor was smaller than it would be predicted from the octanol/water partition coefficient. Furthermore, the depuration was rapid with ≥95% of TRR depurated after three days. As a result, bioaccumulation estimates using KABAM need to account for metabolism or depuration of flutolanil by aquatic biota. Therefore, KABAM model predictions are adjusted to reflect the depuration rate constant value via respiration (k t 

### ) of biota where a vailable 3 

### . For fish,

a measured BCF of 150 L/kg wet wt is available for whole fish ( MRID 41841214, 41841215 )

. From these studies, a k t 

### value of 1.37 days - 1 

### . The k 2 

### value is defined as the BCF value from the study (150) divided by the KABAM estimated k b w 

### value of 297, yielding a k 2 

### value of 0.51. The

k 2 

### value along with the k values associated with growth and elimination processes of large fish that work in clearing the chemical, were subtracting from the k t 

### value to get an estimated K

m 

### value of 0.86 (1 .36

- 0.51

– 0.0036

– 0.0005). This value was used in KABAM to override the

default k

m 

### value for small, medium, and large fish.

3 Although the depuration rate constant in BCF studies is referred to as k 2 , it actually reflects the combined effect faecal elimination, metabolism and growth dilution on c hemical concentrations in tissue. Therefore, these are

referred to here as k t to reflect total depuration rate.- Page 56 of 196

- 

### Suitable data were not available to estimate depuration rates for other taxa considered in KABAM ( e.g. , benthic invertebrates, phytoplankton, zooplankton, filter feeders). Therefore, KABAM results for these taxa may overestimate bioaccumulation to the extent that flutolanil is metabolized by these taxa.

Four pesticide

- specific inputs are required to estimate flutolanil residue concentrations in aquatic organism tissues: 1) log K

ow 

### , 2) K

oc 

### , 3) aqueous concentration of flutolanil , and 4) sediment pore water concentrations of flutolanil . The K

oc 

### and log K

ow 

### are based on registrant

- submitted studies (see Tables 2.1 and 3.5 ). Flut olanil concentrations in pore water and the water column were based on PRZM/EXAMS scenario that produced the maximum EECs ( nursery stock,

ornamentals and fruits (unspecified) , applied via soil drench ; Table 3.1 7 ). Additional model input parameters related to aquatic organisms (including body weight, and food and water intake) and environmental characteristics ( e.g. , temperature, organic carbon content) are default values

in KABAM

.

There were three additional scenarios modeled that spanned a range of pore water and surface

water concentrations. T he same NJ nursery scenario was run as a ground spray application that resulted in concentrations roughly half of those in the soil drench scenario. The turf scenario that

resulted in the highest concentrations wa s also modeled along with the highest rice exposure scenario and highest other food crop scenario (peanut). These scenarios represent a wide range of uses and applications scenarios that are specified on flutolanil labels.

It is noted that the KABAM est imated time to steady state for flutolanil is 4 days based on

environmental fate properties. PRZM/EXAMS provides 4

- day average EECs as part of the output. For flutolanil, it was determined for all scenarios below that were modeled that the 4

- day

average EEC was identical to that of the peak concentration in sediment pore water and total pesticide concentration in water with the exception of the highest scenario modeled (nursery stock and ornamentals, soil drench method). For this scenario, the peak total pesticide concentration in water as shown below was 4690 ppb whereas the 4

- day average was 4670 ppb. This further illustrates the persistence of flutolanil and the justification for the use of PRZM.EXAMS generated peak EECs.

Table 3.1 7 . Bioaccumulation Model Input Values for Flu tolanil

Parameter Input Value Source

Pesticide Name Flu tolanil Log K OW 

### 3. 79 MRID 42606601

K OC 

### 780.7 L/kg OC 

### MRID s 40342943, 42606627

Fish K

m 

### (estimated) 0.86 (for small, medium, and large fish) Calculated: K

m = 

### K t 

### – K 2 

### – K

e 

### - k g


### Highest Exposure Scenario Modeled

Use patterns

Concentration in sediment Nursery stock, ornamentals & fruits (unspecified) ( FL nursery scenario) (soil drench, app rate 21.5 lb a.i./A x 4 at 21 day interval) pore water (ppb) Peak = 4280 ppb;- Page 57 of 196

- 

### Tota l pesticide concentration in water (ppb) Peak = 4690 ppb;



### Additional Exposure Scenarios Modeled

Use patterns Nursery stock, ornamentals & fruits (unspecified) (NJ nursery scenario) ( ground , app rate 9.78 lb a.i./A x 4 at 10 day interval)

Concentration in sediment pore water (ppb) Peak = 2090 ppb

Total pesticide concentration in water (ppb) Peak = 2170 ppb

Use patterns Golf courses, sod farms, spot fields, residential, institutional, municipal & commercial areas (PA turf scenario) (ground, app rate 8.6 a.i/A, 2 at 14 )

Concentration in sediment pore water (ppb) Peak = 210 ppb

Total pesticide concentration in water (ppb) Peak = 217 ppb

Use patterns Rice (CA Rice) (aerial, 2 lbs a.i/A, 1 app)

Concentration in sediment pore water (ppb) Peak = 295 ppb

T otal pesticide concentration in water (ppb) Peak = 1161 ppb

Use patterns Peanuts (NC Peanuts) (aerial, 2 lbs a.i/A, 1 app)

Concentration in sediment pore water (ppb) Peak = 122 ppb

Total pesticide concentration in water (ppb) Peak = 129 ppb



### Table 3.18 below tabulates the total concentrations in μg/kg of flutolanil residues various aquatic organisms tissues at various trophic levels. As the table shows, the modeled scenarios represent a wide range of resultant concentrations in various tissues.

Table 3. 18 . Predicted Concentrations of Flu tolanil in Aquatic Organism Tissues at Different Trophic Levels Resulting from Use on Selected Scenarios

Trophic Level Estimated Total Concentration (μg/kg)

NJ Nursery (soil drench) NJ Nursery (ground spray) PA turf ( ground spray) CA Rice (aerial) NC Peanuts (aerial)



### Phytoplankton 1,354,033 626,493 62,649 335,188 37,243 Zooplankton 994,709 460,238 46,024 246,238 27,360

Benthic Invertebrates 1,083,210 502,461 50,188 259,270 29,844

Filter Feeders 713,581 33 1,004 33,062 170,798 19,660 Small Forage Fish 1,048,487 486,343 48,579 251,032 28,887 Medium Forage Fish 804,426 373,142 37,271 192,549 22,163

Large Forage Fish 528,245 244,431 24,442 130,636 14,530- Page 58 of 196

- 

### 3.3

. Ecological Effects Characterization

The ecolog ical effects characterization for flutolanil is based up on registrant

- submitted toxicity

data for the TGAI ( parent compound ) and for specified formulations

.

Appendix G l ists these studies

, their review classifications

, and associated deficiencies. The ecotoxicity data for flutolanil and its associated products have been reviewed previously in multiple ecological risk assessments ( e.g., USEPA 2006, 2002, 2000 ) and in the Problem Formulation for Registration Review assessment (USEPA 2008). These data are summarized briefly in Sections 3.3.1 and 3.3.2

. Various studies with terrestrial and aquatic plant s, birds, and aquatic animals exposed to either the TGAI or formulated flutolanil have been received since the

Problem Formulation was issued; the results o f these studies are described briefly in this section

.

T he results of a 201 3 review of the Ecological Incident Information System (EIIS) are described

in Section 3.3. (USEPA 20 12 )

. A search of the ECOTOXicology database in October , 2013

, yielded no new data from suitable studies with more sensitive toxicity endpoints than the registrant

- submitted guideline studies described below

.

3.3.1. Aquatic Toxicity Assessment

Flutolanil exposure effects on aquatic organi sms were determined by assessing freshwater fish, freshwater invertebrates, marine/estuarine fish, marine/estuarine invertebrates, marine/estuarine mollusks, and aquatic plants. Each study’s species tested, endpoint, and MRID number are

tabulated below se parated by taxa.

Toxicity to Freshwater Fish

There are four acute freshwater fish toxicity studies available for flutolanil ( Table 3. 19 ) . In a

static study with the rainbow trout ( Salmo gairdneri , MRID 40342933 ), the 96

- hour LC 50 

### was determined to be 5.4 m g a.i/L where mortality occurred only at the highest treatment

concentration

. Fish were exposed to mean measured concentrations of negative control, solvent control, 0.46, 0.65, 0.86, 2.0, 3.0, and 7.0 mg a.i/L. Percent recovery of the chemical rang ed

from 48

– 82% of nominal at test termination. The four highest treatment concentrations had white precipitate observed in the test chambers. T here were daily observations made for

sublethal effects that included surfacing, loss of equilibrium, dark di scoloration, fish on the bottom of the test chamber, curved spine, and quiescence. It was not noted at what

concentrations these effects were observed at. This study is classified as acceptable . There is uncertainty in how much chemical was bioavailable to test organisms as analytical measurements may have included precipitated chemical.

In a second static study conducted with the bluegill sunfish ( Lepomis macrochirus , (MRID

40342934 ), the 96

- hour LC 50 

### was determined to be >5.4 m g a.i/L. Fish were ex posed to mean measured concentrations of negative control, solvent control, 0.31, 0.79, 0.80, 1.6, 2.5, and 5.4 mg a.i/L. Percent recoveries ranged from 45

– 79% of nominal at test termination. Precipitate of- Page 59 of 196

- 

### the test material was observed on the surface at the 0.80, 1.6, 2.5, and 5.4 mean measured treatment concentrations throughout the course of the study. The top treatment concentration during the definitive test killed only 20% of the test population, while the same treatment

concentration killed 100% during the preliminary range

- finding test. It was noted in the DER that this discrepancy may have been due to a solubility factor or due to an age or condition factor of the fish. There were no sublethal effects reported during the study. This study wa s classified as supplemental due to a definitive LC 50 

### not being achieved. There is uncertainty in how much chemical was bioavailable to test organisms as analytical measurements may have included precipitated chemical.

In a static study conducted wit h the common carp ( Cyprinus carpio ) conditions with the MRID

40342936 ), fish were exposed to concentrations of control 1.69, 2.53, 3.80, and 5.70 mg a.i/L. Mortality was 60, 90, and 100% in the three highest treatment concentrations, respectively. Fish

i n the two highest treatment concentrations were noted as swimming sideways or upside down.

The LC 50 

### was determined to be 2.5 mg a.i/L treatment concentrations was 90 and 100% in the 66 and 93 μg a.i/L concentrations, respectively.

In the same study, ca rp were exposed to two other formulations of flutolanil (25% WP and 1.5% dust). Fish were exposed to controls, 3.9, 5.1, 6.7, 8.7, and 11.2 mg a.i/L (mean measured concentrations) with the highest mortality at 60% in the highest treatment concentration. Fish were observed swimming upside down or sideways in all treatment concentrations. The LC 50 

### was determined to be 5.5 mg a.i/L. Fish were also exposed to the 1.5% dust formulation of flutolanil at concentrations of 3.94, 5.12, 6.65, 8.65, and 11.24 mg a.i/L. Mortality was highest at 60% in the highest treatment concentration. Fish were observed swimming upside down or sideways in all treatment concentrations. The LC 50 

### was determined to be 6.4 mg a.i/L. This study was classified as supplemental as th e carp is not a guideline recommended species. It is worth noting that the three highest treatment concentrations of this study are above the solubility

limit of flutolanil.

In an acute static study conducted with the fathead minnow ( Pimephales promelas

, MRID

41841216 ), fish were exposed to mean measured concentrations of control, solvent control, 1.2, 2.2, 3.7, 6.6 and 11 mg a.i/L. Percent recoveries ranged from 92

- 110 % of nominal values at test termination. White precipitate was observed at the top o f the test chamber in the two highest treatment concentrations. Eighty and 100% mortality occurred in the two highest treatment concentrations, respectively with noted sublethal effects including loss of equilibrium, quiescence, surfacing, and erratic swi mming that were observed at the 3 middle treatment concentrations (2.2, 3.7, and 6.6 mg a.i/L). There were no sublethal effects noted in the highest

treatment concentration as all fish were dead after 24 hours. The LC 50 

### was determined to be 4.8.

This st udy was classified as acceptable. There is uncertainty in how much chemical was bioavailable to test organisms as analytical measurements may have included precipitated

chemical.

These studies indicate that flutolanil is moderately toxic to freshwater fish on an acute exposure

basis. However, it is apparent that acute toxicity to fish occurs near or above the aqueous solubility limit of flutolanil ( 6.53 mg/L )- Page 60 of 196

- 

### 1 Table 3. 19 . Summary of Acute Toxicity Data for Freshwater Fish Expo sed to Flutolanil

Species Study Type Purity of test substance LC 50 (mg a.i/L) 1,2,3
(95% CL; slope) Toxicity

Classification (MRID)

Rainbow trout ( Oncorhynchus mykiss ) 96

- hour,

static 97.8 96

- h LC 50 : 5.4 (N/A; N/A) Moderately toxic ( 40342933 ) Bluegill su nfish ( Lepomis

Macrochirus ) 96

- hour,

static 97.8 96

- h LC 50 : > 5.4 (N/A; N/A) Moderately toxic ( 40342934 ) Carp (Cyprinus carpio) 96

- hour,

static Technical grade (purity not specified) 96

- h LC 50 : 2.5 (2.1

– 3.0; 9.3) Moderately toxic ( 40342936 )

Carp 96

- h our, static 25% WP 96

- h LC 50 : 5.5 (4.6

– 6.2; 10.3) Moderately toxic ( 40342936 )

Carp 96

- hour,

static 1.5% Dust 96

- h LC 50 : 6.4 (5.4

– 7.4; N/A) Moderately toxic ( 40342936 )

Fathead minnow ( Pimephales promelas ) 96

- hour,

static 97.6 96

- h LC 50 : 4.8 (3.8

– 6 .2; 6.5) Moderately toxic ( 41841216 )

CL: Confidence limits. LC 50 : Lethal concentration to 50% of the population. N/A = not applicable

1 Bolded values represent the most sensitive toxicity endpoints for freshwater fish exposed to parent flutolanil an d

therefore will be used in risk estimation.

2 Based on mean measured concentrations.

3 If probit slope data were not available, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effe ct (Urban and Cook 1986).


### In a 3 5

- day chronic early life stage study, fathead minnow were exposed to flutolanil under flow

through conditions ( Table 3.2 0 ) . Fish were exposed to mean measured concentrations of negative control, solvent control 0.17, 0.23, 0.49, 0.93, and 1.9 mg a.i/L. One hundred percent mortality occurred at the highest treatment concentration by the time of test termination. As a result, wet weight and total length measurements were not assessed for this treatment

concentration. There were n o significant physical or behavioral abnormalities that were noted during this study. The NOAEC and LOAEC for this study were determined to be 0.22 and 0.49 mg a.i/L, respectively based on significant reductions in length as compared to the negativ e control. This study was classified as acceptable.

Table 3.2 0

. Summary of Chronic Toxicity Data for Freshwater Fish Exposed to Flutolanil

.

Species Study Type Purity of test

substance NOAEC; LOAEC (mg a.i/L) Endpoints

affected ( MRI D)

Fathead minnow (Pimephales promelas ) 35

- day early life stage 98.9 NOAEC: 0.22

LOAEC: 0.49 Growth (length) ( 43552001 ) N/A: Not applicable or available.

1 Bolded values represent the most sensitive toxicity endpoints for freshwater fish exposed to parent flutolanil, and

therefore will be used in risk estimation.

2 Based on mean measured concentrations



### Toxicity to Freshwater Invertebrates

There are two acute toxicity tests available for the freshwater invertebrate s. ( Table 3.2 1 ) . In a static study Daphnia magna , organis ms were exposed to treatment concentrations of negative control, solvent control, 0.75, 1.4, 2.2, 4.1 and 6.8 mg a.i/L. Percent recoveries ranged from 58

- 68% of the nominal concentrations throughout the course of the study. A precipitate was present

on t he bottom of the test vessel in the highest concentration tested. It is noted that the highest- Page 61 of 196

- 

### mean measured concentration used for this study represents the limit of solubility for flutolanil (6. 53 mg/L). There was less than 50% effect mortality or immo bilization at the highest

treatment concentration and therefore the EC 50 

### was determined to be 6.8 mg a.i/L. It is also noted however that the top concentration (at the limit of solubility) determined 45% mortality at

this level. There were no sublethal e ffects noted during the study. This stud y is classified as acceptable. There is uncertainty in how much chemical was bioavailable to test organisms as analytical measurements may have included precipitated chemical.

In a second study, which was a 96

- h our flow

- through exposure, crayfish ( Procambarus clarkii ) 

### were exposed to mean measured concentrations of negative control, solvent control, 0.51, 0.92, 1.8, 3.2, and 6.0 mg a.i/L. Percent recoveries ranged from 60

– 81% of the nominal

concentrations. It was noted in the DER that a large amount of precipitate was observed in the diluter. The presence of the precipitate, it was noted, indicates that the solubility of flutolanil in water was exceeded under the conditions of the test, despite the attempts t o maximize the solubility with the use of dimethylformamide at the maximum concentration permitted. There were no sublethal effects or mortality observed at any treatment concentration throughout the course of the study. The EC 50 

### was determined to be >6. 0 mg a.i/L and this study is classified as supplemental due to the use of a non

- g uideline recommended species. There is uncertainty in how much chemical was bioavailable to test organisms as analytical measurements may have included precipitated chemical.

These studies indicate that flutolanil is moderately toxic to freshwater invertebrates on an acute exposure basis. Additionally these studies indicate that an EC 50 

### was not achieved at the limit of solubility for flutolanil (6.53 mg/L).

Table 3.2 1

. Sum mary of Acute Toxicity Data for Freshwater Invertebrates Exposed to

Flutolanil

.

Species Study Type Purity of test

substance EC 50 (mg a.i/L) 1,2,3
(95% CL;

slope) Toxicity Classification (MRID)

Water flea ( Daphnia magna ) 48

- hr, static TGAI (98.9%) >6.8 (N /A; N/A) Moderately toxic (41841217) Crayfish ( Procambarus

clarkii ) 96

- hr, flow

through TGAI (98.9%) >6.0 (N/A; N/A) Moderately toxic (42606620)

CL: Confidence limits. NA: Not available or applicable.

1 Bolded values represent the most sensitive toxicit y endpoints for freshwater invertebrates exposed to parent

flutolanil and therefore will be used in risk estimation.

2 Based on mean measured concentrations

3 If probit slope data were not available, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).



### In a chronic life cycle study conducted with Daphnia magna under a static renewal system (MRID 41850807 ), mean measured concentrations were control, solvent control, 0.29, 0.53, 1.1, 2.0, and 4.0 mg a.i/L ( Table 3.2 2 )

. Percent recoveries of the nominal concentrations ranged from

80

- 97% and a precipitate was observed in the three highest treatment concentrations. Percent survival was significantly different (p< 0.05) from the negative control in the highest treatment concentration. Adult Daphnid length and time (in days) to first brood was significantly different- Page 62 of 196

- 

### (p<0.05) as compared to the negative controls in the two highest treatment concentrations. The

numb er of young produced per adult reproductive day was significantly reduced (p<0.05) from the negative control in the three highest treatment concentrations. There were no sublethal effects noted during the study. Based on the number of young per adult rep roductive day, the NOAEC and LOAEC for this study were determined to be 0.53 and 1.1 mg a.i/L, respectively. This study is classified as acceptable.

Table 3.2 2 . Summary of Chronic Toxicity Data for Freshwater Invertebrates Exposed to

Flutolanil

.

Speci es Study Type Test Substance (Purity) NOAEC;

LOAEC (m g a.i /L) 1,2 Endpoints

affected (MRID)

Water flea ( Daphnia magna ) 21

- day Life Cycle, static

renewal TGAI (98.9%) 0.53; 1.1 Number of young per female and

dry weight (41850807)

1 Bolded values repres ent the most sensitive toxicity endpoints for freshwater invertebrates exposed to parent

flutolanil and therefore will be used in risk estimation.

2 Based on mean measured concentrations



### Toxicity to Estuarine/Marine Fish

Table 3.2 3 shows the acute toxici ty study results for the estuarine/marine fish species Cyprinodon variegatus , MRID 41841218. Fish were exposed to mean measured concentrations of negative control, solvent control, 0.61, 1.2, 2.1, 3.7, and 6.1 mg a.i/L. Percent recoveries ranged from 78

– 103% throughout the course of the study. Sublethal effects that were noted during the study included loss of equilibrium, quiescence, surfacing, labored respiration, and fish being observed on the bottom of the test vessel. These effects were noted at the two highest treatment concentrations. As there was no mortality observed in the study, the LC 50 

### was determined to be >6.1 mg a.i/L. This study was formally considered supplemental as a definitive

LC 50 

### had not been achieved but it was upgraded to ac ceptable upon re

- review based on lack of toxicity at the solubility limit of flutolanil (6.53 mg/L).

Table 3.2 3 . Summary of Acute Toxicity Data for Estuarine/marine fish Exposed to

Flutolanil.

Species Study Type Purity of test

substance LC 50 (mg a.i/L) 1 ,2,3
(95% CL; slope) Toxicity

Classification (MRID) Sheepshead minnow ( Cyprinodon variegatus ) 96

- hour, static 98.9 > 6.1 (N/A; N/A) Moderately Toxic (41841218)

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine fish exp osed to parent flutolanil

and therefore will be used in risk estimation.

2 Based on mean measured concentrations.

3 Probit slope data were not available; therefore, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive t he probability of an individual effect (Urban and Cook 1986).- Page 63 of 196

- 

### A chronic early life stage (ELS) toxicity study with marine/estuarine fish may be conditionally required for flutolanil solely based on its persistence in water of > 4 days. 4 

### In response to a previous data request associated with the 2000 assessment on potato seed pieces, the registrant submitted a waiver request for a full life cycle study for marine/estuarine fish in 2002. This waiver request was based on the toxicological profile of the c hemical and expected

concentrations in the marine/estuarine environment and was considered sufficient to waive the full life cycle study. Based on similar lines of evidence, the Agency placed the conditionally

required, chronic ELS test with marine/estuar ine fish on reserve pending receipt and review of any additional information (e.g. from the registrant or public literature) that would suggest that marine/estuarine fish might be sufficiently sensitive to flutolanil such that the risk assessments

conclusi ons would be affected by additional data for marine/estuarine fish. The Agency has yet

to receive such information.

The Agency, when possible, employs the use of an acute

- to

- chronic ratio (ACR) to estimate an indefinite (i.e. unbounded) measure of toxici ty for chronic taxa when sufficient data are available. In this case, acute and chronic toxicity data from freshwater fish species and acute toxicity data from estuarine/marine species would be used to estimate a chronic NOAEC for

estuarine/marine fish. As stated in the summary for the acute toxicity study for estuarine/marine fish however, there was no mortality that occurred up to the limit of solubility, and therefore no

definitive LC 50 

### was reached. There is inherent uncertainty when estimating an ACR with definitive toxicity endpoints and even greater uncertainty when an ACR is estimated with non

definitive endpoints and therefore chronic risk to estuarine/marine fish will not be estimated. See

the Risk Characterization Section for the impact on the o verall risk assessment.

Toxicity to Estuarine/Marine Invertebrates

Two acute estuarine/marine invertebrate studies have been submitted in support of flutolanil ( Table 3.2 4 ) . In a 96

- hour oyster shell deposition study with the eastern oyster ( Crassostrea virginica , MRID 41841219 ), oysters were exposed to mean measured concentrations of negative control, solvent control, 0.017, 0.46, 0.68, 0.91, and 1.5 mg a.i/L

. These values represented 19

- 31% recovery of the nominal values. It was noted in the DER that concentrations generally increased slightly during the exposure period. There was no insoluble material observed in any treatment vessel for the first 72 hours of the study, but by 96 hours, all test vessels has white particles present at the bottom. Th ere was a decrease in shell growth (12% reduction) in the highest treatment concentration as compared to the negative control. As a result t he EC 50 

### was determined to be >1.5 m g a.i/L. There were no s ublethal effects that were noted in the study.

This st udy is classified as acceptable.

In an acute toxicity study conducted with the mysid shrimp ( Americamysis bahia , MRID 41841220), organisms were exposed to mean measured concentrations of negative control, solvent control, 0.020, 0.027, 0.049, 0.087, 0.16, and 0.29 mg a.i/L. Percent recoveries ranged

from 84

– 111% of nominal concentrations. Ninety and 100% mortality occurred at the two highest treatment concentrations, respectively. There were no sublethal effects noted during the

4 Pesticide Data Requirements for Conventional Chemicals. CFR Part 158. Federal Register. Vol. 72 (No. 207):

60934

- 60988. October, 26, 2007- Page 64 of 196

- 

### study and the LC 50 

### was determined to be 0.13 mg a.i/L. This study is classified as acceptable.

Table 3.2 4

. Summary of Acute Toxicity Data for Estuarine/Marine Invertebrates Exposed

to Flutolanil

.

Species Study Type Test Substance (Purity) E C 50 LC/ 50 (m g a.i /L) 1,2 ,3
(95% CL; s lope) Toxicity

Classification (MRID) Eastern oyster ( Crassostrea virginica ) 96

- hour, flow

through TGAI ( 98.9 %) >1.5 (N/A; N/A) Moderately Toxic (41841219) Mysid shrimp (Americamysis bahia) 96

- hour, static TGAI ( 98.9 %) 0.13 (0.087

– 0.16; N/R) Highly Tox ic (41841220)

N/R = Not reported

1 Bolded values represent the most sensitive toxicity endpoints for estuarine/marine invertebrates exposed to parent

flutolanil and therefore will be used in risk estimation.

2 Based on mean measured concentrations.

3 Prob it slope data were not available; therefore, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).



### In a chronic toxicity study with the mysid shrimp (MRID 43511601), mysids were exposed t o mean measured concentrations of negative control, solvent control, 4.23, 11.3, 21.7, 42.8, and 89.7 μg a.i/L ( Table 3.2 5 ) . There was a significant decrease (p<0.05) from the negative control for percent survival, product ion of young per female, and dry weight in the three highest treatment concentrations. There were no sublethal effects noted as having been observed in the study. Based on effect to survival, number of young per female, and dry weight, the NOAEC

and LOAE C of this study are 11.3 and 21.7 μg a.i/L, respectively. This represents a 42% reduction on survival, 67% reduction in number of young per female, and 16% reduction in dry weight. This study is classified as acceptable.

2 Table 3.2 5

. Summary of Chronic Toxicity Data for Estuarine/Marine Invertebrates Exposed to Flutolanil

.

Species Study Type % Active Ingredient (a.i.) Toxicity Endpoint ( μg a.i/L ) Endpoints affected (MRID)

Mysid shrimp (Americamysis bahia) 28

- d Life Cycle 98.9 N OAEC: 11.3

LOAEC: 21.7 Number of young per female, percent survival, dry weight ( 43511601 )

1 Bolded values represent the most sensitive toxicity endpoints for freshwater invertebrates exposed to parent

flutolanil and therefore will be used in risk estimat ion.

2 Based on mean measured concentrations



### Toxicity to Aquatic Plants

There are six aquatic plant toxicity studies available for flutolanil ( Table 3.2 6 ) . In a vascular aquatic plant study conducted with Lemna gibba (MRID 42606622), the test species wa s exposed to a single nominal concentration of 8.01 mg a.i/L. There was a 30% reduction in frond number that occurred in the single treatment concentration as compared to the negative control.

An EC 50 

### was undetermined as there was no effect greater than 50%. A two

- sample t

- test indicates that this percent reduction from the negative control is a significant (p<0.05) effect and therefore a definitive NOAEC could not be determined. This study is classified as acceptable- Page 65 of 196

- 

### with an EC 50 

### of >8.01 mg a.i/L an d a NOAEC of <8.01 mg a.i/L.

In an algal toxicity study conducted with the estuarine/marine diatom Skeletonema costatum (MRID 42606623), cells were exposed to a single nominal concentration of flutolanil of 8.01 mg

a.i/L. There was a 12% reduction in cel l counts in the limit concentration as compared to the negative control. An EC 50 

### was undetermined as there was no effect greater than 50%. A two sample t

- test indicates that this reduction from the negative control is a significant (p<0.05)

effect and th erefore a definitive NOAEC could not be determined. This study is classified as acceptable with an EC 50 

### of >8.01 mg a.i/L and a NOAEC of <8.01 mg a.i/L.

In an algal toxicity study conducted with the cyanobacteria Anabaena flos

- aquae (MRID 42606621), ce lls were exposed to a single nominal concentration of flutolanil of 8.01 mg a.i/L. There was a 28% reduction in cell counts in the limit concentration as compared to the negative control. A two sample t

- test indicates that this reduction from the negat ive control is a significant (p<0.05) effect and therefore a definitive NOAEC could not be determined. This study is classified as acceptable with an EC 50 

### of >8.01 mg a.i/L and a NOAEC of <8.01 mg

a.i/L.

In an algal toxicity study conducted with the fr eshwater diatom Navicula pelliculosa (MRID 42606624), cells were exposed to a single nominal concentration of flutolanil of 8.01 mg a.i/L. There was a 61% reduction in cell counts in the limit concentration as compared to the negative control. A two samp le t

- test indicates that this reduction from the negative control is a significant (p<0.05) effect and therefore a definitive NOAEC could not be determined. This study is classified as acceptable with an EC 50 

### of <8.01 mg a.i/L and a NOAEC of <8.01 mg

a.i/ L.

In a second toxicity study conducted with the freshwater diatom Navicula pelliculosa (MRID 42606625), cells were exposed to a single nominal concentration of flutolanil of 0.8 mg a.i/L mg a.i/L, presenting the maximum labeled rate for rice applicatio ns. There was an 11% reduction in cell counts in the limit concentration as compared to the negative control , which was not determined to be statistically significant (p>0.05) . An EC 50 

### was undetermined as there was no effect greater than 50%. This study is classified as acceptable with an EC 50 

### of >0.80 mg a.i/L and a NOAEC of 0.80 mg a.i/L.

In an algal toxicity study conducted with the freshwater green algae Selenastrum capricornutum (MRID 41841224), cells were exposed to a single nominal concentratio n of flutolanil of 8.01 mg a.i/L. There was a 58% reduction in cell counts in the limit concentration as compared to the negative control. A two sample t

- test indicates that this reduction from the negative control is a significant (p<0.05) effect and th erefore a definitive NOAEC could not be determined. This study is classified as acceptable with an EC 50 

### of <8.01 mg a.i/L and a NOAEC of <8.01 mg

a.i/L.

It is worth noting that for every study except the freshwater diatom study using the rice applicati on rate (MRID 42606625 ), that the limit concentration of 8.01 mg a.i/L exceeds the solubility limit of flutolanil (6.53 mg/L)- Page 66 of 196

- 

### 3 Table 3.2 6

. Summary of Toxicity Data for Vascular and Nonvascular Aquatic Plants Exposed to Flutolani l

Species Exposure Duration, Type Test Substance (Purity) NOAEC;

EC 50 (mg a.i./L) (95% CL) 1 Effect ( MRID)

Duckweed (Lemna gibba) 14

- day, static TGAI (98.4%) < 8.01 ; >8.01 (N/A) 3 0 % reduction in frond

count

( 42606622 )

Marine d iatom ( Skeletonema costatum ) 5

- day, static TGAI ( 98.4 %) < 8.01 ; >8.01 (N/A) 1 2 % inhibition for cell

counts

( 42606623 )

Cyanobacteria ( Anabaena flos

- aquae ) 5

- day, static TGAI ( 98.4 %) < 8.01 ; >8.01 (N/A) 28 % inhibition for cell

counts

( 42606621 )

Freshw ater d iatom ( Navicula pellicu losa ) 5 day, static TGAI ( 98.4 %) < 8.01 ; <8.01 (N/A) 61 % inhibition for cell

counts

( 42606624 )

Freshw ater d iatom ( Navicula pelliculosa ) 5 day, static TGAI ( 98.4 %) 0.80; >0.80 (N/A) 11% inhibition for cell

counts

( 42606625 )

Freshwater g reen a lgae

(Sele nastrum capricornutum) 5 day, static TGAI ( 98.4 %) < 8.01 ; <8.01 (N/A) 58 % growth inhibition

( 41841224 )

N / A Not available.

1 Bolded values represent the most sensitive toxicity endpoints for nonvascular aquatic plants exposed to parent

flutolanil and theref ore will be used for risk estimation.



### 3.3.2. Terrestrial Effects Summary

There have been nine studies submitted to characterize flutolanil’s effects on terrestrial organisms. These studies included two avian acute oral toxicity studies, two avian dietar y studies, two avian reproduction studies, and one acute contact toxicity study to the honey bee. In addition, two studies submitted to the Health Effects Division (HED), were used to obtain endpoints to be used for the evaluation of the effects on mammal s. These studies were a rat acute oral toxicity study and a rat two

- generation study. Additionally, there are two terrestrial plant studies available , one each of seedling emergence and vegetative vigor.

Toxicity Effects on Birds

There are two available avian acute oral toxicity studies available for flutolanil ( Table 3.2 7 ) . In a study with the northern bobwhite quail ( Colinus virginianus , MRID 40342930), birds were- Page 67 of 196

- 

### exposed to treatment levels of control, 500, 1000, and 2000 mg a.i/kg bw. There were no mortalities observed nor were they any clinical sings of toxicity, effect on body weight, or on food consumption. As there were no mortalities, the LD 50 

### of this study was determined to be >2000 mg a.i/kg bw. This study is classified as acceptable.

In a second avian acute oral toxicity study conducted with the mallard duck ( Anas platyrhynchos

, MRID 40342929), birds were exposed to treatment levels of control, 500, 1000, and 2000 mg a.i/kg bw. There were no mortalities observed nor were they any clinic al sings of toxicity, effect on body weight, or on food consumption. As there were no mortalities, the LD 50 

### of this study was determined to be >2000 mg a.i/kg bw. This study is classified as acceptable.

There are two available avian sub

- acute dietary toxicity studies available for flutolanil ( Table

3.29 ) . In a study conducted with the northern bobwhite quail (MRID 40342932), birds were exposed to treatment concentrations of control, 500, 800, 1280, 2048, 3277, and 5243 ppm

flutolanil. The sole mortal ity in the study was observed in the control group on Day 3. There were no observed clinical signs of toxicity, effects on body weight, or on food consumption. The

LC 50 

### for this study was determined to be >5243 ppm and this study is classified as accepta ble.

In a second study conducted with the mallard duck (MRID 40342931), birds were exposed to treatment concentrations of control, 500, 800, 1280, 2048, 3277, and 5243 ppm flutolanil. There were no mortalities observed in this study nor were there obser ved clinical signs of toxicity, effects on body weight, or on food consumption. The LC 50 

### for this study was determined to be >5243 ppm and this study is classified as acceptable.

These studies indicate that flutolanil is practically non

- toxic to birds o n an acute oral and sub

acute dietary basis.

4 Table 3.2 7

. Summary of Acute and Sub

- acute Toxicity Data for Birds Exposed to

Flutolanil

Species Study Type Test

Substance

(Purity) LD 50 (mg/kg bw) or LC 50 mg/kg diet); (95% CI; slope) 1,2 Toxicity

Classification (MRID)

Northern Bobwhite Quail

(Colinus virginianus ) Acute oral toxicity TGAI ( 97.5 %) 14

- d LD 50 : >2000 (N/A; N/A) Practically non

toxic ( 40342930 )

Mallard Duck ( Anas platyrhynchos ) Acute oral toxicity TGAI ( 97.5 %) 14

- d LD 50 : > 2000 (N/A; N/A) Practically non

toxic ( 40342929 )

Northern Bobwhite Quail

(Colinus virginianus ) Subacute dietary toxicity TGAI ( 97.5 %) 8

- d L C 50 : >5243 (N/A; N/A) Practically non

toxic ( 40342932 )

Mallard Duck ( Anas platyrhynchos ) Subacute dietary toxicity TGAI ( 97.5 %) 8

- d LC 50 : >5243 (N/A; N/A) Practically non

toxic ( 40342931 ) N.A = not applicable

1 Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation

2 Based on mean measured concentrations- Page 68 of 196

- 

### There are two available studies characterizing the reproductive effects of flutolanil on birds ( Table 3. 28 ) . In a study with the northern bobwhite quail (MRID 42932301), birds were exposed to treatment concentrations of control, 400, 960, 1920, and 4800 ppm. There were no

trea tment

- related mortalities, overt signs of toxicity, or treatment related effects on body weight at any concentration tested. When compared to the negative control, there were no statistically significant effects (p<0.05) on any reproductive parameters. W hile not statistically significant, there was a slight reduction in the number of eggs laid at the highest concentration tested that study authors attributed to a increase in the number of hens that laid a smaller number of eggs (<20) during the study. Th is reduction in egg production was also reflected in the number of hatchlings and 14

- day survivors as percentages of the maximum number of eggs set. While not statistically significant, the reduction in eggs laid at the highest treatment concentration as compared to the negative control is a 17% reduction and is viewed as biologically meaningful. The NOAEC and LOAEC for this study based on eggs laid (and consequently normal hatchlings,

and 14

- day old survivors) was determined to be 1920 and 4800 ppm, resp ectively. This study is classified as acceptable.

In a study with the mallard duck (MRID 42932302), birds were exposed to treatment concentrations of control, 400, 960, 1920, and 4800 ppm. There were no treatment

- related mortalities, overt signs of to xicity, or treatment related effects on body weight at any concentration tested. There were statistically significant (p<0.05) reductions in eggshell thickness at the 400 and 4800 ppm treatment groups, the lowest and highest levels tested

. At the 4800 pp m treatment level, the mean eggshell thickness was 0.382 ± 0.026 mm. This thickness

was comparable to both the historical control value of 0.385 ± 0.0 14 mm, and the 400 ppm group
mean value of 0.383 ± 0.0 23 mm. The 400 pp m treatment value was not statisti cally significant

from the control value of 0.403 ± 0.0 24 mm. However, while only one pen in the 400 ppm group had an egg shell thickness value below 0.357 mm, four pens (25%) from the 4800 ppm group

were below that value. The reduction in egg shell thickn ess at 4800 ppm was considered to biologically significant , while the reduction observed at the 400 ppm test level was not. Furthermore, it was determined that since the effect did not follow a dose

- responsive pattern, that

the effect at the lowest treatm ent level could be discounted. The NOAEC and LOAEC for this study based on eggshell thickness was 1920 and 4800 ppm . This stud y is classified as acceptable.

5 Table 3. 28 . Summary of Chronic Toxicity Data for Birds Exposed to Fluto lanil.

Species Study Type % Active Ingredient (a.i.) Toxicity Endpoint

(ppm) Endpoints

affected (MRID) Northern Bobwhite Quail (Colinus virginianus ) Chronic reproduction TGAI (98.9%) NOAEC: 1920

LOAEC: 4800 Eggs laid

42932301

Mallard Duck ( Anas platyrhyn chos ) Chronic reproduction TGAI ( 98.9 %) NOAEC: 1920

LOAEC: 4800 Eggshell

thickness

42932302

Bold ed values indicate the most sensitive endpoint used for flutolanil risk estimation.



### Toxicity Effects on Mammals- Page 69 of 196

- 

### In an acute oral exposure study to the laborat ory rat ( Rattus norvegicus , MRID 40342905), the

LD 50 

### was determined to be >10000 mg a.i/kg bw which classifies flutolanil as practically non

toxic to mammals on an acute oral basis ( Table 3. 29 )

. 6 Table 3. 29

. Summary of Acute and Chronic Mammalian Toxicity Data for Rats Exposed

to Flutolanil 1,2

Species Study Type Acute

LD 50 (mg/kg bw) Toxicity

Classification (MRID) NOAEC (mg/kg diet) Endpoints (MRID)

Norway rat

( Rattus norvegicus ) 98.2 LD 50 : >10,000 Practically non

- toxic Accep table 40342906

1 Mammalian toxicity data for flutolanil TGAI provided by EPA Health Effects Division

2 Bolded values represent the most sensitive toxicity endpoint and will be used for risk estimation



### In a two

- generation reproductive toxicity study (MRID 4 1850805), TGAI flutolanil was administered daily in the diet at treatment concentrations of control, 200, 2000, or 20000 ppm. This approximates to 0, 16, 159, or 1625 mg/kg/d for males and 0, 19, 190, or 1936mg/kg/d for

females. There were no treatment r elated parental effects observed in either sex or generation. There was also no treatment related reproductive toxicity observed. Consequently, the NOAEL was determined to be 20,000 ppm and the LOAEL was >20,000 ppm ( Table 3.3 0 )

7 Table 3.3 0

. Toxic Effects in Mammals Due to Chronic Exposure to Flutolanil

Species % Active Ingredient (a.i.) Toxicity Endpoint (mg/kg

- diet ) Study Classification MRID #

Rat 98.3 NOAEL: 20,000 LOAEL : >20,000 Acceptable 41850805

Bolded values indicate t he most sensitive endpoint used for flutolanil risk estimation.



### Toxicity Effect s on Terrestrial Plants

There are two Tier II terrestrial plant studies available for flutolanil ( Table 3.3 1 ) . In a seedling emergence study (MRID 48603202), flutolanil was a pplied as a formulation (40.6% a.i) to 4 species of monocots and 6 species of dicots in concentrations of control, 0.54, 1.1, 2.2, 4.3, and 8.6 lbs a.i/A (nominal concentrations). In lettuce inhibitions ranged from 6.5 to 29% and in flax

from 16 to 32%. Emergence was significantly (p<0.05) reduced from the negative control in all but the lowest treatment concentration (0.54 lbs a.i/A) for flax and the two highest treatment concentrations (4.3 and 8.38 lbs a.i/A) in lettuce. Survival in the negative contr ol ranged from 65 to 98%. Inhibition for lettuce was a maximum of 38.5% and for flax ranged from 10 to 38%. Survival was significantly (p<0.05) reduced from the negative control in all but the lowest treatment concentration (0.54 lbs a.i/A) for flax an d the two highest treatment concentrations (4.3 and 8.38 lbs a.i/A) in lettuce

Plant h eight was significantly reduced (p<0.05) at the three highest treatment concentrations (2.2, 4.3, and 8.38 lbs a.i/A) in wheat and in the highest treatment concentration for ryegrass.- Page 70 of 196

- 

### Inhibitions ranged from maximums of 40 to 43% for lettuce and flax. Inhibitions in ryegrass were 29, 24 and 43% at the 2.2, 4.3 and 8.6 lb ai/A treatment levels. Corn, onion, soybean, and tomato generally experienced promotion only. Dry weight was significantly reduced from the negative control in all but the lowest treatment concentration (0.54 lbs a.i/A) for flax and wheat and for the (ryegrass). This study partially satisfies the guideline requirement for a Tier II seedling emergence study as the most sensitive endpoints for flax (most sensitive dicot) was survival and emergence. Further examination of the data revealed that multiple replicates in all

but one treatment concentration had emergence of 50% or below. This confounded the ability to interpret sublethal effects on plant height and weight. This study is still suitable for quantitative risk assessment and is classified as supplemental. The most sensitive monocot was ryegrass with

EC 25 

### and NOAEC values of 3.66 and 2.20 lbs a.i /A, respectively based on effects to plant weight. The most sensitive dicot was flax with EC 25 

### and NOAEC values of 1.45 and 0.54 lbs a.i/A, respectively based on effects to survival.

In a Tier II Vegetative Vigor (MRID 48603201), flutolanil was exposed as a formulation (40.6% a.i) to 4 species of monocots and 6 species of dicots at concentrations of control, 0.54, 1.1, 2.2, 4.3, an d8.17 lbs a.i/A (mean measured). Survival in the negative control ranged from 96.7 to 100%. There was generally promotion or no change in survival compared to the negative control in cabbage, flax, lettuce, radish, soybean and wheat. Inhibitions in survival for corn, onion, ryegrass, and tomato ranged from maximums of 3 to 7%. There was promotion of height in onion, radish and soybean. Inhibitions in height ranged from maximums of 2.2 to 10% for all other species with the highest inhibition in ryegrass of 13%. There was general promotion of weight in lettuce and soybean. Inhibitions in dry weight ranged from maximums of 2 to 12% for all other species with the exception of onion and ryegrass. The highest inhibitions were observed for onion and ryegrass (17 and 26%, r espectively). A most sensitive dicot species could not be determined due to a lack of toxicity, with an ove rall NOAEC value of 8.17 lb ai/A.

T his toxicity study is scientifically sound and partially satisfies the guideline requirement for a Tier II vegetative vigor study (all crops except ryegrass had definitive endpoints) . For ryegrass, length and weight r esponses at the lowest treatment concentrations were significantly reduced (p<0.05). Ryegrass length had a 12.7% reduction from control at the lowest treatment level (0.54 lb a.i/A). For weight, percent reductions were 26.3, 22.1, 8.8, 12.0, and 25.2% fro m the control for the 0.54, 1.1, 2.2, 4.3, and 8.2 lb a.i/A treatment concentrations, respectively. As two levels (lowest and highest) exhibited a 25% inhibition, and due to the U

- shaped pattern of the data, the regression model did not converge and there fore an EC 25 

### was not able to be estimated

fro m this dataset. As a result, the most sensitive monocot species could not be determined in

this study as a NOAEC was not achieved and an EC 05 

### could not be used in its place for risk

estimation to listed monoco ts. Data from all other species is suitable. Therefore, this study is classified as supplemental. As there is no definitive EC 25 

### or NOAEC (or EC 05 

### ) values, toxicity

to listed and nonlisted monocots cannot be fully characterized

.

Table 3.3 1

. Toxic Effec ts in Terrestrial Plants D ue to Exposure to Flutolanil

Species Study Type % Active Ingredient (a.i.) Toxicity Endpoint ( lbs a.i/A ) Endpoints

affected (MRID) Multiple Seedling TEP ( 40.6 %) Monocot (ryegrass) : EC 25 : 3.66 (0.747

– Monocots:- Page 71 of 196

- Species Study Type % Active Ingredient (a.i.) Toxicity Endpoint ( lbs a.i/A ) Endpoints

affected (MRID) Species Emergence 17.9); NOA EC: 2.20

Dicot (Flax) : EC 25 : 1.45 (N/A);

NOAEC: 0.54 Weight

Dicots:

Survival

48603202

Multiple species Vegetative Vigor TEP ( 40.6 %) Monocot (ryegrass): EC 25 : <0.54 (N/A ); NOAEC: <0.54

Dicot ( could not determined ): EC 25 : >8.17 (N/A); NOAEC: 8 .17 Monocots: Weight

Dicots:

Survival

48603201

N/A = Not available



### Toxicity Effects on Insects

An acute contact study using the formulated flutolanil (Moncut Dry Flowable, 65% a.i) was conducted with the results listed below in Table 3.3 2

. Mortality was 8.7% in the highest dose level (650 ppm). This acute contact study also examined the toxicity of residues on foliage. Flutolanil (as Moncut Dry Flowable, 65% a.i) was blended with water and applied to rapeseed plants. Bees were caged on treated foliage for at predetermined intervals post treatment. There was no further information in the DER regarding results of the study other than that flutolanil was practically non toxic to honey bees as a foliar residue. This study is classified as acceptable.

8 Table 3.3 2 . Toxic Effects in Insects Due to Acute Exposure to Flutolanil

Species % Active Ingredient (a.i.) Toxicity Endpoint

(ppm) Toxicity

Classification Study

Classification MRID #

Honey bee ( Apis mellifera ) 65 (Monocot dry

flow able) LD 50 (contact):

> 650 Practically non

toxic Acceptable 40342938

Bold values indicate the most sensitive endpoint used for flutolanil risk estimation.



### Toxicity Effects on Sediment

- Dwelling Aquatic Invertebrates

In a 10

- day sediment toxicity tes t with the freshwater midge ( Chironomus tentans , MRID 48776801), flutolanil was spiked into the sediment at mean measured concentrations of control, solvent control, 49, 131, 233, 415, and 1060 mg TRR/kg. The TRR denotes total radioactive

residues as the chemical was radiolabeled to track it through the sediment and pore water. Corresponding mean measured pore water concentrations were control, solvent control, 14.1, 20.8, 32.5, 51.9, and 80.6 mg TRR/L. Mean survival after 10 days ranged from 88

– 96% am ong the controls and treatment groups and there were no significant reductions (p>0.05) indicated when compared to the negative control. Differences were statistically reduced when compared to the solvent control (p>0.05) at the highest treatment concentr ation. A two sample t

- test
indicates a non

- significant difference between the negative and solvent control (6.7% effect). The results of the comparisons to the negative control are therefore used , per EFED guidance

.

Ash

- free dry weight (AFDW) averaged 1.27, 1.48, 1.49, 1.62, 1.48, 1.68, and 1.59 mg per midge- Page 72 of 196

- 

### in the negative control, solvent control, 49, 131, 233, 415, and 1060 mg TRR/kg treatment groups, respectively. Differences were not statistically

- significant compared to each of the

control level s independently. There was a significant (p<0.05) difference between the negative and solvent control (14.5% increase for solvent over negative), but again, there were no significant reductions (p>0.05) when compared to either the negative or solvent cont rol. Since all treatments contained the same amount of solvent and none showed a statistically

- significant difference relative to either control, the significant increase in AFDW in solvent controls is

considered not to be solvent or treatment related.

T he NOAEC and LOAEC (survival and growth) for this study were determined to be 1060 mg and >1060 mg TRR/kg sediment respectively, based on mean m easured sediment concentrations; 80.6 mg TRR/L and >80.6 mg TRR/L respectively based on mean mea sured pore wate r concentrations; and 35,300 mg TRR/kg TOC (total organic carbon) and >35,000 TRR/kg TOC based on organic

- carbon normalized mean measured sediment concentrations. This study is classified as acceptable.

In a 10

- day sediment toxicity test with the estuari ne/marine amphipod ( Leptocheirus plumulosus

, MRID 48802201), flutolanil was spiked into the sediment a mean measured concentrations of negative control, sol vent control, 1.7, 2.8, 7.4, 14, a nd 34 mg TRR/kg sediment. Mean measured pore water concentrations were negative control, solvent control, 2.6, 5.4, 10, 7, and 8.4 mg TRR/L. The pore water concentrations do not follow an increasing trend in measurements and

an examination of the replicate sampling data indicate the initial day 0 measurement of the 7.4 mg TRR/kg sediment level was substantially elevated above the Day 10 measurement. There was no explanation in the study report regarding this observation.

Survival after 10 days averaged 94 and 97% for the negative and solvent control levels, respectiv ely, compared to 90, 90, 82, 85, and 78% for the mean

- measured 1.7, 2.8, 7.4, 14, and 34 mg TRR/kg sediment levels, respectively. Differences were statistically

- significant (p<0.05) compared to the negative control (96%) at the 34 mg TRR/kg level (the hig hest treatment concentration). The 10

- day NOAEC and LOAEC were 14 and 34 mg TRR/kg, respectively based on mean measured sediment concentrations; 7.0 and 8.4 mg TRR/L based on mean measured pore water concentrations; and 519 and 1260 mg TTR/kg TOC based on organic normalized mean measured sediment concentrations. This study is classified as acceptable.

For the purposes of risk estimation, 1 mg TRR/kg sediment, mg TRR/L, and mg TRR/kg TOC is assumed to be 1 mg a.i/kg sediment, mg a.i/L, and mg a.i/kg TOC, respectively. Please see the risk description section for further details regarding the rationale for this assumption.

Table 3.3 3 . Toxic Effects in Sediment

- Dwelling Organ i sm due to Exposure to Flutolanil

Species Study Type Test

Substance

(Purity) Sedi ment L C 50 (mg a.i / kg

sediment ) 1
(95% CL;

slope) 3 Pore

water
LC 50 (mg a.i/L) Sediment

NOAEC (mg a.i/kg sediment) 1,2 Pore

water
NOAEC (mg a.i/L) MRID- Page 73 of 196

- Species Study Type Test

Substance

(Purity) Sedi ment L C 50 (mg a.i / kg

sediment ) 1
(95% CL;

slope) 3 Pore

water
LC 50 (mg a.i/L) Sediment

NOAEC (mg a.i/kg sediment) 1,2 Pore

water
NOAEC (mg a.i/L) MRID

Freshwater midge

Chironomus

tentans 10

- day,

whole

sediment TGAI (9 8.7 %) Mean measured

= > 1060 (N/A; N/A)

O C

- normalized =

> 35300 (N/A; N/A) >80.6 mg a.i/L

(N/A; N/A) Mean

measured =

1060

OC

normalized =

35

, 300 80.6 48776801

Estuarine /

marine amphipod Leptocheirus plumulosus 10

- day,

whole

sediment TGAI (98.9 %) Mean measured

= > 34 (N/A; N/A)

OC

- normalized =

> 1260 (N/A; N/A) > 8.4 mg a.i/L (N/A; N/A) Mean

measured =

14

OC

normalized =

519 7.0 48802201

1 Bolded values represent the most sensitive toxicity endpoints for fresh water sediment

- dwelling invertebrates exposed to parent flutolanil and therefore will b e used in risk estimation.

2 Based on mean measured concentrations. Endpoints in these studies were expressed as mg TRR (total radioactive residues)/kg sediment. This was assumed to be equivalent to mg a.i/kg sediment. See the risk description section

fo r more information.

3 OC

- normalized refers to the mean measured sediment concentrations being normalized for the organic carbon

content in the test sediment.



### 3.3. 3

. Review of Incident Data

The Ecological Incident Information System (EIIS)

, which is mainta ined by the Agency’s Office of Pesticide Programs, was searched to determine if ecological incidents have been reported for

flutolanil

. Based on a search of EIIS conducted in October, 2013

, there was one reported

incident associated with flutolanil

. In th is incident, (Incident ID I014123

- 001) the observed effect (yellowing and stunting of 40 acres of oats) was determined to be more likely due to fertility issues than flutolanil and was classified as ‘unlikely.’

The American Bird Conservancy (ABC) Avian In cident Monitoring System (AIMS) was searched in October 2013 and returned no records of incidents associated with flutolanil (ABC

, 2007).

A search in October 2013 of the Incident Database System (IDS) maintained by OPP’s

Information Technology and Resour c e Manag ement Division (ITRMD) yielded no incident s for

flutolanil in the main database nor in the aggregate incident module. Because of limitations in the incident reporting system, the lack of additional incident reports cannot be construed as the

absenc e of incidents from the registered use of flutolanil

.



## 4. Risk Characterization

4.1. Screening

- Level Risk Quotient (RQ) Values- Page 74 of 196

- 

### This screening

- level ass essment of the labeled use s of flutolanil relies on the deterministic RQ method to provide a metric of potential risks. The RQ provides a comparison of exposure estimates to toxicity endpoints ( i.e. , the estimated exposure concentrations are divided by acute and chronic toxicity values , respectively ). The resulting unitless RQ values are compared to the Agency’s LOCs, as shown in Table s 4.1 through Table 4. 18

. The LOCs are used by the Agency to indicate when the use of a pesticide, as directed by the label, has the potential to cause adverse

effects to non

- target organisms. In this assessment, RQ s that exceed the non

- listed species LOC

also exceed the listed species LOC.

T ables 4.1

– 4.17 provide the resulting, screening

- level RQ values, for taxa with sufficient data. Note that with plants, unlike with animals, RQ values are not presented for acute ver sus chronic risk; instead, RQ values are presented for listed and nonlisted species based on a comparison of a given EEC to NOAEL and E C 25 

### /EC 50 

### values, respectively. A discussion of the RQ values for

flutolanil and of other information that provides conte xt for the interpretation of potential risk to various taxa is presented in the Risk Description in Section 4.2

.

4.1.1. RQ Values for Aquatic Organisms

Acute risk to freshwater fish and aquatic

- phase amphibians is based on 1 in 10 year peak EECs

in the s tandard pond and the lowest acute toxicity value for freshwater fish

. Chronic risk is based on the 1 in 10 year 60

- day EECs and the lowest chronic toxicity value for freshwater fish.

Acute and chronic r isk quotients for freshwater fish are shown in Tab le 4.1

. Acute RQs ranged

from <0.01

– 1. 88 and chronic RQs ranged from <0.01

– 20.59

. Five of ten ( 50 %) of the

flu tolanil uses (at least one modeled scenario) exceeded at least one acute risk LOC and two uses exceeded the chronic risk LOC. The probabil ity of an individual chance of effect was estimated using the study derived slope of 9.3 from the most sensitive freshwater fish study (carp, MRID

40342936 )

. For all food uses except peanut and rice, RQ values were below levels of concern except for one m odeled scenario for peanuts (aerial application) in which the acute endangered species LOC was met.

Table 4. 1 . Acute and Chronic RQs for Direct Effects to Freshwater Fish from Flutolanil

TGAI. 1

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Fish

EC 50 = 2500

μg a.i/L 60

- day

EECs

(μg

a

. i

. /L) Freshwater

Fish

NOAEC = 220 μg a.i/L

Acute RQ Chronic RQ

Peanut NC

peanut In

- furrow at plant 30.1 0.01 29.4 0.13

Peanut NC

peanut Ground banded apps 41.8 0.02 40.7 0.19

Peanut NC

peanut Aerial 12 9 0.05 124 0.56

Brassica (cole) Leafy Vegetables (Crop Group 5) plus CA cole

crops Ground in a

narrow band 36.7 0.01 35.8 0.16- Page 75 of 196

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Fish

EC 50 = 2500

μg a.i/L 60

- day

EECs

(μg

a

. i

. /L) Freshwater

Fish

NOAEC = 220 μg a.i/L

Acute RQ Chronic RQ

Turnip Greens

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens FL cabbage Ground in a

narrow band 71.4 0.03 7 0.3 0.32

Potatoes ID Potato In furrow band app 8.27 <0.01 8.18 0.04

Potatoes ME

Potato In furrow band app 30.1 0.01 29.8 0.14

Potatoes ID Potato Seed piece

treatment 2.33 <0.01 2.31 0.01

Potatoes ME

Potato Seed piece

treatment 12.5 0.01 12.4 0.06

Cott on CA cotton Seed

treatment 0.158 <0.01 0.147 <0.01

Cotton MS cotton Seed

treatment 2.67 <0.01 2.6 0.01

Soybeans MS soybean Seed

treatment 20 0.01 19 0.09

Sugarbeet MN sugarbeet Seed

treatment 0.289 <0.01 0.285 <0.01

Golf courses

, sod farms, spot

field s, residential

, institutional, municipal & commercial areas FL turf Ground 170 0.07 162 0.74

Golf courses

, sod farms, spot fields, residential

, institutional, municipal & commercial areas PA turf Ground 217 0.09 210 0.95

Ornamental lawns and turf;

recrea tion area lawns; residential lawns; Commercial/

Industrial lawns FL turf Ground 178 0.07 173 0.79

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Ground 2300 0.92 2170 9.86

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Ground 2170 0.87 2140 9.73

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Soil drench 4690 1.88 4530 20.59

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Soil drench 3700 1.48 3590 16.32

Rice 3 AR rice Aerial 1120 0.45 382 1.74

Rice 4 AR rice Aerial 829 0.33 366 1.66

Rice 3 CA rice Aerial 1161 0.46 431 1.96

Rice 4 CA rice Aerial 870 0.35 416 1.89

Rice LA rice Aerial 1100 0.44 350 1.59

Rice MS rice Aerial 1100 0.44 365 1.66- Page 76 of 196

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Fish

EC 50 = 2500

μg a.i/L 60

- day

EECs

(μg

a

. i

. /L) Freshwater

Fish

NOAEC = 220 μg a.i/L

Acute RQ Chronic RQ

Rice TX rice Aerial 1130 0.45 393 1.79

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

2 Slope was available from most sensitive acute freshwater fish toxicity study which was 9.3

3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### Acute risk to freshwater invertebrates is based on 1 in 10 year peak EECs in the standard pond and the lowest acute toxicity value for freshwater invertebrates. Chronic risk is based on the 1 in 10 year 21

- day EECs and the lowest chronic toxicity value for freshwater invertebrates. Acute and chronic risk quotients for freshwater invertebrates are shown in Table 4. 2

. There is uncertainty with respect to the acute RQs in that the y were estimated using non

- definitive endpoints ( i.e. “>” value). While there was no treatment concentration in the available acute toxicity study, tested up to the solubility limit of flutolanil, where 50% or more mortality was observed, there was 45% mo rtality observed at the highest treatment concentration. While there are no EECs that were estimated that exceed the limit of solubility, the potential risk of exposures that approach the highest treatment (where 45% mortality occurred) cannot be

discount ed. If the assumption was made that the top treatment dose was the EC 50 

### , resultant RQs

would indicate a potential for risk above the LOC for the nursery stock and rice uses only.

C hronic RQs ranged from <0.01

– 8.70

. Two of ten ( 2 0 %) of the flutolanil u ses (at least one modeled scenario) exceeded the chronic LOC. It is noted that for freshwater invertebrates, the

EC 50 

### was a “greater than,” value and therefore the resultant RQs represent an upper bound “worst case,” scenario of risk. There is uncertaint y with respect to how far below the estimates

of acute risk to freshwater invertebrates would be. For example, the uses on rice ( RQs range from <0.12

- <0.17) could all be below the restricted use LOC of 0.1 and even below the endangered species LOC of 0. 05 but this statement cannot be made with certainty. The probability of an individual chance of effect was estimated using the default slope of 4.5 as there was not a suitable slope that could be derived from the most sensitive freshwater invertebrate

tox icity study.

Table 4

. 2

. Acute and Chronic RQs for Direct Effects to Freshwater Invertebrates from

Flutolanil TGAI

. 1

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = >6800 μg a.i/L 21

- day

EECs

(μg

a

. i

. /L) Freshwater

Inver tebrates

NOAEC = 530 μg a.i/L

Acute RQ Chronic RQ

Peanut NC

peanut In

- furrow at plant 30.1 <0.01 29.8 0.06- Page 77 of 1 96

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = >6800 μg a.i/L 21

- day

EECs

(μg

a

. i

. /L) Freshwater

Inver tebrates

NOAEC = 530 μg a.i/L

Acute RQ Chronic RQ

Peanut NC

peanut Ground

banded

apps 41.8 <0.01 41.3 0.08

Peanut NC

peanut Aerial 129 <0.02 126 0.24

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens CA cole

crops Ground in a

narrow

band 36.7 <0.01 36 0.07

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens FL cabbage Ground in a

narrow

band 71.4 <0.01 70.6 0.13

Potatoes ID Potato In furrow band app 8.27 <0 .01 8.22 0.02

Potatoes ME

Potato In furrow band app 30.1 <0.01 30 0.06

Potatoes ID Potato Seed piece

treatment 2.33 <0.01 2.32 <0.01

Potatoes ME

Potato Seed piece

treatment 12.5 <0.01 12.4 0.02

Cotton CA cotton Seed

treatment 0.158 <0.01 0.153 <0.01

C otton MS

cotton Seed

treatment 2.67 <0.01 2.63 <0.01

Soybeans MS soybean Seed

treatment 20 <0.01 19.7 0.04

Sugarbeet MN sugarbeet Seed

treatment 0.289 <0.01 0.287 <0.01

Golf courses

, sod farms, spot fields, residential

, institutional, municipal &

commer cial areas FL turf Ground 170 <0.03 168 0.32

Golf courses

, sod farms, spot fields, residential

, institutional, municipal &

commercial areas PA turf Ground 217 <0.03 214 0.40

Ornamental lawns and turf; recreation area lawns;

residential lawns;

Commercial/ Industrial

lawns FL turf Ground 178 <0.03 177 0.33

Nursery stock, ornamentals

& fruits (unspecified) FL

nursery Ground 2300 <0.34 2240 4.23

Nursery stock, ornamentals

& fruits (unspecified) NJ

nursery Ground 2170 <0.32 2160 4.08

Nursery stock, ornament als

& fruits (unspecified) FL

nursery Soil drench 4690 <0.69 4610 8.70- Page 78 of 196

- Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = >6800 μg a.i/L 21

- day

EECs

(μg

a

. i

. /L) Freshwater

Inver tebrates

NOAEC = 530 μg a.i/L

Acute RQ Chronic RQ

Nursery stock, ornamentals

& fruits (unspecified) NJ

nursery Soil drench 3700 <0.54 3650 6.89

Rice 3 AR rice Aerial 1120 <0.16 600 1.13

Rice 4 AR rice Aerial 829 <0.12 522 0.98

Rice 3 CA rice Aerial 1161 <0.17 649 1.22

Rice 4 CA rice Aerial 870 <0.13 569 1.07

Rice LA rice Aerial 1100 <0.16 578 1.09

Rice MS rice Aerial 1100 <0.16 588 1.11

Rice TX rice Aerial 1130 <0.17 611 1.15

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

, italicized values represent a potential to exceed an

LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

2 Slope was not available from most sensitive acute freshwater invertebrate toxicity study and therefore default slope
of 4.5 was employed for probably of acute effect estimates



### . 3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### The available acute toxicity study with estuarine/marine fish indic ated that there were no concentrations tested (including and up to 6.1 mg a.i/L) where mortality was observed. A

definitive LC 50 

### therefore was not established. As all peak EECs that were modeled for the proposed and registered uses of flutolanil were bel ow 6.1 mg a.i/L and no mortalities were observed up to and including this treatment , acute risk levels below the level of concern can be presumed for estuarine/marine fish.

As discussed in Section 4, an acute

- to

- chronic ratio (ACR) is typically used when available data allow for the estimation of an indefinite (i.e. unbounded) measure of toxicity for either acute or chronic data. There is uncertainty that is inherent in the use of an ACR but it can serve to provide an estimate of where risk will fall. In the case of flutolanil, while freshwater acute and chronic toxicity studies yielded definitive endpoints, the available acute estuarine /marine study

observed no mortalities (as discussed above). The usage of an ACR with a non

- definitive endpoint would in troduce further uncertainty into any estimate of toxicity and therefore no chronic risk to estuarine/marine fish will be estimated for flutolanil. See the Risk Description Section for the impact on the overall risk assessment.

Acute risk to estuarine/mar ine invertebrates is based on 1 in 10 year peak EECs in the standard pond and the lowest acute toxicity value for estuarine/marine invertebrates . Chronic risk is based on the 1 in 10 year 21

- day EECs and the lowest chronic toxicity value for estuarine/mar ine

invertebrates . Acute and chronic risk quotients for estuarine/marine invertebrates are shown in

Table 4.3 . Acute RQs ranged from <0.01

– 36.1 and chronic RQs ranged from 0.01

– 408.- Page 79 of 196

- 

### Eight of ten ( 80 %) flutolanil uses that (at least one modeled scen ario) exceeded at least one acute

risk LOC and the chronic LOC

. The probability of an individual chance of effect was estimated using the default slope of 4.5 as a slope was not available from the most sensitive acute estuarine/marine fish toxicity study

. In contrast with previous taxa assessed, RQ values for

estuarine/marine invertebrates exceed levels of concern all food uses except sugarbeet and all

non

- food uses.

Table 4.3 . Acute RQs for Direct Effects to Estuarine/Marine Invertebrates from Flutola nil

TGAI. 1

Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 130 μg a.i/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 11.3 μg

a.i/L

Acute RQ Chronic RQ

Peanut NC

peanut In

- furrow at plant 30.1 0.2 3 29.8 2.64

Peanut NC

peanut Ground

banded

apps 41.8 0.32 41.3 3.65

Peanut NC

peanut Aerial 129 0.99 126 11. 2

Brassica (cole) Leafy

Vegetables (Crop Group 5) plus Turnip

Greens CA cole

crops Ground in

a narrow

band 36.7 0.28 36 3.19

Brassica (cole) Lea fy

Vegetables (Crop Group 5) plus Turnip

Greens FL cabbage Ground in

a narrow

band 71.4 0.55 70.6 6.25

Potatoes ID Potato In furrow band app 8.27 0.06 8.22 0.73

Potatoes ME

Potato In furrow band app 30.1 0.23 30 2.65

Potatoes ID Potato Seed piece

treatm ent 2.33 0.02 2.32 0.21

Potatoes ME

Potato Seed piece

treatment 12.5 0.10 12.4 1.10

Cotton CA

cotton Seed

treatment 0.158 <0.01 0.153 0.01

Cotton MS

cotton Seed

treatment 2.67 0.02 2.63 0.23

Soybeans MS soybean Seed

treatment 20 0.15 19.7 1.74

Sugarbe et MN sugarbeet Seed

treatment 0.289 <0.01 0.287 0.03

Golf courses

, sod farms, spot fields,

residential

, institutional, municipal

& commercial areas FL turf Ground 170 1.31 168 14. 9- Page 80 of 196

- Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 130 μg a.i/L 21

- day

EECs

(μg ai/L) Estuarine/marine

Invertebrates

NOAEC = 11.3 μg

a.i/L

Acute RQ Chronic RQ

Golf courses

, sod farms, spot fields,

residential

, institutional, munici pal

& commercial areas PA turf Ground 217 1.67 214 18.9

Ornamental lawns and

turf; recreation area

lawns; residential lawns; Commercial/

Industrial lawns FL turf Ground 178 1.37 177 15. 7

Nursery stock,

ornamentals & fruits (unspecified) FL

nursery Ground 2300 17. 7 2240 198

Nursery stock,

ornamentals & fruits (unspecified) NJ

nursery Ground 2170 16. 7 2160 191

Nursery stock,

ornamentals & fruits (unspecified) FL

nursery Soil

drench 4690 36. 1 4610 40 8

Nursery stock,

ornamentals & fruits (unspecified) NJ

n ursery Soil

drench 3700 28. 5 3650 323

Rice 3 AR rice Aerial 1120 8.62 600 53.1

Rice 4 AR rice Aerial 829 6.38 522 46. 2

Rice 3 CA rice Aerial 1161 8.93 649 57.4

Rice 4 CA rice Aerial 870 6.69 569 50. 4

Rice LA rice Aerial 1100 8.46 578 51. 2

Rice MS rice Ae rial 1100 8.46 588 52.0

Rice TX rice Aerial 1130 8.69 611 54. 1

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

2 Slope was not available from most sensitive acute estuarine/marine invertebrate toxicity study and therefore default slope of 4.5 was employed for probably of acute effect estimates.

3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### 4.1 .2. RQ Values for Aquatic Plants

Risk to aquatic non

- vascular plants is based on 1 in 10 year peak EECs in the standard pond and

the lowest EC 50 

### value and NOAEC value. Listed species RQs are derived from a compar i son of the peak EEC to t he most sensitive NOAEC and non lis t ed RQs are derived from a comparison of the peak EEC to the most sen s it i ve EC 50 

### value available. Risk quotients for listed aquatic nonvascular plants were not estimated since there are currently no list ed aquatic non

- vascular- Page 81 of 196

- 

### species

. F or nonlisted aquatic nonvascular plants

, t here is un certainty

, in the nonlisted species RQs as these RQs were determined using a non

- definitive EC 50 

### value (“<”) and therefore the RQs represent an lower bound, “ best case,” scenario of risk. For the nursery and turf uses in particular, it can be stated with high certainty based on the data and the level of the EECs that risk to aquatic non

- vascular plants would be indicated for nursery stock and rice. For all other uses, there is potential for an exceedance of the LOC but it is an uncertainty as to what extent

those exceed a nces would be.

Non

- listed species RQs for aquatic vascular plants were determined using a non

- definitive EC 50 

### (“>”) and therefore represent an upper bound “worst case,” scenario of risk. Consequently, the resultant RQs are preceded by a “<” value to indicate what level of risk would be yielded at

most

. There were no exceedances for listed species for aquatic vascular plants. There is uncertainty with these RQs as well as they were dete rmined using a non

- definitive NOAEC (“<”) in which the resultant RQs represent a lower bound, “best case,” scenario of risk. Resultant RQs therefore are preceded with a “>” sign in which the values denote a level of risk that at least be

indicated (Table 4. 4 )

.

Table 4. 4

. RQ Values for Direct Effects to Aquatic Nonvascular Plants from Flutolanil

TGAI. 1 ,2

Use (s) Scenario Application

Method Peak

EECs

(μg

ai /L) Aquatic

Nonvascular

Plants

E C 50 = < 800 μg

a.i/L Aquatic Vascular

Plants

E C 50 = >8010 μg

a.i/L

NOAEL = <8010 μg

a.i/L

Nonlisted RQs 4 Listed RQs 3 Nonlisted RQs 4

Peanut NC

peanut In

- furrow at plant 30.1 > 0.04 >0.0 1 <0.01

Peanut NC

peanut Ground banded apps 41.8 > 0.05 >0.01 <0.01

Peanut NC

peanut Aerial 129 > 0.16 >0.02 <0.02

Brassica (cole) L eafy Vegetables (Crop Group 5) plus Turnip Greens CA cole

crops Ground in a

narrow band 36.7 > 0.05 >0.0 1 <0.01

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens FL cabbage Ground in a

narrow band 71.4 > 0.09 >0.01 <0.01

Potatoes ID Potato In furrow band

app 8.27 > 0.01 >0.0 1 <0.01

Potatoes ME

Potato In furrow band

app 30.1 > 0.04 >0.0 1 <0.01

Potatoes ID Potato Seed piece

treatment 2.33 > 0.01 >0.0 1 <0.01

Potatoes ME

Potato Seed piece

treatment 12.5 > 0.02 >0.0 1 <0.01

Cotton CA cotton Seed treatment 0.158 > 0.01 >0.0 1 <0.01

Cotton MS cotton Seed treatment 2.67 > 0.01 >0.0 1 <0.01- Page 82 of 196

- Use (s) Scenario Application

Method Peak

EECs

(μg

ai /L) Aquatic

Nonvascular

Plants

E C 50 = < 800 μg

a.i/L Aquatic Vascular

Plants

E C 50 = >8010 μg

a.i/L

NOAEL = <8010 μg

a.i/L

Nonlisted RQs 4 Listed RQs 3 Nonlisted RQs 4

Soybeans MS soybean Seed treatment 20 > 0.03 >0.0 1 <0.01

Sugarbeet MN sugarbeet Seed treatment 0.289 > 0.01 >0.0 1 <0.01

Golf courses

, sod farms, spot fields, residen tial

, institutional, municipal & commercial areas FL turf Ground 170 > 0.21 >0.02 <0.02

Golf courses

, sod farms, spot fields, residential

, institutional, municipal & commercial areas PA turf Ground 217 > 0.27 >0.03 <0.03

Ornamental lawns and turf;

recreati on area lawns; residential lawns; Commercial/

Industrial lawns FL turf Ground 178 > 0.22 >0.02 <0.02

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Ground 2300 > 2.88 >0.29 <0.29

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Gr ound 2170 > 5 .71 >0.27 <0.27

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Soil drench 4690 > 5 .86 >0.59 <0.59

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Soil drench 3700 > 4.63 >0.46 <0.46

Rice 5 AR rice Aerial 1120 > 1.40 > 0.14 <0.14

Rice 6 AR rice Aerial 829 > 1.04 >0.10 <0.10

Rice 5 CA rice Aerial 1161 > 1.45 >0.14 <0.14

Rice 6 CA rice Aerial 870 > 1.09 >0.11 <0.11

Rice LA rice Aerial 1100 > 1.38 >0.14 <0.14

Rice MS rice Aerial 1100 > 1.38 >0.14 <0.14

Rice TX rice Aerial 113 0 > 1.41 >0.14 <0.14

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Listed aquatic plant LOC = 1; Non

- listed aquatic plant LOC = 1

3 Estimated by dividing the peak EEC by the most sensitive NOAEC

4 Estimated by dividing the peak EEC by the most sensitive EC 50 5 1 application of 0.980 lbs a.i/A

6 2 applications of 0.490 lbs a.i/A



### 4.1. 3

. RQ Values for Sediment

- Dwelling Organisms

Acute and chronic risk to freshwater and estuarine/marine benthic invertebrates is estimated in several different ways to account for multiple exposure routes of flutolanil to benthic invertebrates and to account for factors contributing to the bioavailability of flutolanil across those exposure routes. Acute risk quotients are based on the peak pore water EEC and the most- Page 83 of 196

- 

### sensitive water column EC 50



### . Chronic RQs are derived several different ways, accounting for the multiple exposure routes and differing bioavailability . Modeled 21

- day pore water EECs are compared to the measured pore water NOAEC from available sediment s tudies; modeled 21

- day sediment EECs are compared to the measured sediment NOAEC; and modeled 21

- day pore water EECs are compared to the most sensitive surface water NOAEC.

Acute risk quotients for freshwater benthic invertebrates ranged from <0.01

– < 0.6 3 (Table 4. 5 )

. There is uncertainty with respect to these RQs as they were estimated using a non

- definitive endpoint (“>”) and therefore the resultant RQs are preceded with a “<” that represent an upper bound “worst case,” scenario of risk. As with the to xicity endpoint for water column freshwater invertebrates, which is used to derive acute risk to freshwater sediment dwelling invertebrates, the RQ exceedances that exceed the acute level of concern cannot be discounted as there was 45% mortality observed at the limit of solubility. Therefore, for the nursery stock and ornamental uses, there is the potential for the exceedance of the acute LOC.

Chronic RQs for benthic invert e brates based off of toxicity values expressed in terms of

sedimen t concentratio n s (EECs and toxicity endpoints) ranged from < 0.1

– 0.01 and therefore there were no registered or proposed uses of flutolanil that exceeded the LOC when concentrations were expressed in terms of sediment concentrations. When expressed in terms of

pore water EECs and endpoints from sediment toxicity studies expressed in terms of pore water, there no uses of flutolanil that exceeded the LOC (RQs ranged from <0.01

– 0.05). Finally

, chronic RQs based on pore water EECs compared to surface water endpoints resu lted in RQs that exceeded the LOC for one use of flutolanil (nursery stock, ornamentals and fruits

, unspecified ), RQs ranged from 0.01

– 8.08

.

Table 4. 5 . Acute RQ and Chronic RQs for Direct Effects to Freshwater Sediment

- Dwelling

Invertebrates from F lu tolanil TGAI. 1, 6

Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface

water ) 5

Peanut NC

peanut In

furrow at

plant 28.8 < 0.0 1 22800 28.8 <0.01 <0.01 0.05

Peanut NC

peanut Ground

banded

apps 39.9 < 0.01 31500 39.9 <0.01 <0.01 0.08

Peanut NC

peanut Aerial 122 < 0.02 96400 122 <0.01 <0.01 0.23- Page 84 of 196

- Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface

water ) 5

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip

Greens CA cole

crops Ground

in a

narrow

band 34.4 < 0.01 26900 34.0 <0.01 <0.01 0.06

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip

Greens FL cabbage Ground

in a

narrow

band 67.8 < 0.01 53600 67.8 <0.01 <0.01 0.13

Potatoe s ID

Potato In

furrow band app 8.03 <0.01 6350 8.03 <0.01 <0.01 0.02

Potatoes ME

Potato In

furrow band app 29.4 <0.01 23200 29.4 <0.01 <0.01 0.06

Potatoes ID

Potato Seed piece

treatment 2.24 <0.01 1770 2.24 <0.01 <0.01 <0.01

Potatoes ME

Potato Seed piec e

treatment 12.3 <0.01 9720 12.3 <0.01 <0.01 0.02

Cotton CA

cotton Seed

treatment 0.140 <0.01 111 0.140 <0.01 <0.01 <0.01

Cotton MS

cotton Seed

treatment 2.47 <0.01 1950 2.47 <0.01 <0.01 <0.01

Soybeans MS soybean Seed

treatment 18.8 <0.01 14900 18.7 <0. 01 <0.01 0.04

Sugarbeet MN sugarbeet Seed

treatment 0.279 <0.01 220 0.279 <0.01 <0.01 <0.01

Golf

courses
, sod farms, spot

fields,

residential

, institutional, municipal &

commercial

areas FL turf Ground 157 < 0.02 124000 157 <0.01 <0.01 0.30

Golf

courses
, sod farms, spot PA turf Ground 204 < 0.03 161000 204 <0.01 <0.01 0.38- Page 85 of 196

- Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface

water ) 5

fields,

residential

, institutional, municipal &

commercial

areas Ornamental

lawns and turf;

recreation area lawns;

residential

lawns;

Commercial/

Industrial

lawns FL turf Ground 169 < 0. 02 134000 169 <0.01 <0.01 0.32

Nursery

stock,

ornamentals

& fruits (unspecified) FL

nursery Ground 2010 <0.30 1590000 2010 0.05 0.02 3.79

Nursery

stock,

ornamentals

& fruits (unspecified) NJ

nursery Ground 2090 <0.31 1650000 2090 0.05 0.03 3.94

Nursery

stock,

ornamentals

& fruits (unspecified) FL

nursery Soil

drench 4280 <0.63 3380000 4280 0.10 0.05 8.08

Nursery

stock,

ornamentals

& fruits (unspecified) NJ

nursery Soil

drench 3480 <0.51 2750000 3480 0.08 0.04 6.57

Rice AR rice Aerial 247 < 0.04 201000 2 46 0.01 <0.01 0.46

Rice AR rice Aerial 245 < 0.04 201000 245 0.01 <0.01 0.46

Rice CA rice Aerial 295 < 0.04 241000 295 0.01 <0.01 0.56

Rice CA rice Aerial 294 < 0.04 241000 294 0.01 <0.01 0.55

Rice LA rice Aerial 225 < 0.03 183000 224 0.01 <0.01 0.42

Rice MS rice Aerial 233 < 0.03 188000 230 0.01 <0.01 0.43

Rice TX rice Aerial 263 < 0.04 214000 262 0.01 < 0.0 1 0.49- Page 86 of 196

- 1 Bolded and shaded values indicate an exceedance of an LOC

, italicized values represent a potential to exceed an

LOC

2 Based on peak pore water E EC divided by >6800 ug a.i/L ( E C 50 value of most sensitive fresh water water column

invertebrate )

3 Based on 21

- day organic carbon (OC)

- normalized sediment EECs divided by OC

- normalized NOAEC of

Chironomus dilutus (MRID 48776801 ) of 80600 μg a.i/kg sediment.

4 Based on 21

- day pore water EECs divided by pore water NOAEC of Chironomus dilutus (MRID 48776801 ) of

35300000 μg a.i/L.

5 Based on 21

- day pore water EECs divided by 530μg a.i/L (NOAEC value of most sensitive freshwater water

column invertebrate )

6 Acute li sted species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### Acute risk quotients for estuarine/marine benthic invertebrates ranged from <0.01

– 32.92 (Table

4. 6 )

. There were 8 of 10 ( 8 0%) of flutolanil uses tha t exceeded at least one acute LOC for at least

one modeled scenario.

Chronic RQs for benthic invertebrates based off of toxicity values expressed in terms of

sediment concentration s (EECs and toxicity endpoints) ranged from < 0.1

– 6.51

. Only the

nursery stock, ornamentals and fruits (unspecified) use exceeded the chronic LOC. When expressed in terms of pore water EECs and endpoints from sediment toxicity studies expressed in terms of pore water, there no uses of flutolanil that exceeded the LOC (RQs rang ed from <0.01

– 0.61). Finally

, chronic RQs based on pore water EECs compared to surface water endpoints resulted in RQs that ranged from 0.01

– 379. There were 8 of 10 (80%) of flutolanil uses that

exceeded at least one acute LOC for at least one mod eled scenario.

Table 4. 6 . Acute RQ and Chronic RQs for Direct Effects to Estuarine/Marine Sediment

Dwelling Invertebrates from Flutolanil TGAI. 6

Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs ( mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface water) 5

Peanut NC

peanut In

furrow at

plant 28.8 0.22 22800 28.8 0.04 < 0.0 1 2.55

Peanut NC

peanut Ground

banded

apps 39.9 0.31 3150 0 39.9 0.06 0.01 3.53

Peanut NC

peanut Aerial 122 0.94 96400 122 0.19 0.02 10.8

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip

Greens CA cole

crops Ground

in a

narrow

band 34.4 0.26 26900 34.0 0.05 <0.01 3.01

Brassica (cole) Leafy FL cabbage Ground

in a 67.8 0.52 53600 67.8 0.10 0.01 6.00- Page 87 of 196

- Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs ( mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface water) 5

Vegetable s (Crop Group 5) plus Turnip

Greens narrow band

Potatoes ID

Potato In

furrow band app 8.03 0.06 6350 8.03 0.01 < 0.0 1 0.71

Potatoes ME

Potato In

furrow band app 29.4 0.23 23200 29.4 0.04 < 0.0 1 2.6 0

Potatoes ID

Potato Seed piece

treatment 2.24 0.02 1770 2.24 < 0.0 1 < 0.0 1 0.20

Potatoes ME

Potato Seed piece

treatment 12.3 0.09 9720 12.3 0.02 < 0.0 1 1.09

Cotton CA

cotton Seed

treatment 0.140 < 0.0 1 111 0.140 < 0.0 1 < 0.0 1 0.01

Cotton MS

cotton Seed

trea tment 2.47 0.02 1950 2.47 < 0.0 1 < 0.0 1 0.22

Soybeans MS soybean Seed

treatment 18.8 0.14 14900 18.7 0.03 < 0.0 1 1.65

Sugarbeet MN sugarbeet Seed

treatment 0.279 <0.01 220 0.279 <0.01 < 0.0 1 0.02

Golf

courses
, sod farms, spot

fields,

residential

, institutio nal, municipal &

commercial

areas FL turf Ground 157 1.21 124000 157 0.24 0.02 13.9

Golf

courses
, sod farms, spot

fields,

residential

, institutional, municipal &

commercial

areas PA turf Ground 204 1.57 161000 204 0.31 0.03 18.1

Ornamental

lawns and

turf ; FL turf Ground 169 1.30 134000 169 0.26 0.02 15.0- Page 88 of 196

- Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs ( mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface water) 5

recreation area lawns;

residential

lawns;

Commercial/

Industrial

lawns Nursery

stock,

ornamentals

& fruits (unspecified) FL

nursery Ground 2010 15.5 1590000 2010 3.06 0.29 178

Nursery

stock,

ornamentals

& fruits (unspecified) NJ

nursery Ground 2090 16.1 1650000 2090 3.18 0.30 185

Nursery

stock,

ornamentals

& fruits (unspecified) FL

nursery Soil

drench 4280 32.9 3380000 4280 6.51 0.61 379

Nursery

stock,

ornamentals

& fruits (unspecified) NJ

nursery Soil

drench 3480 26.8 2750000 3480 5.30 0.50 308

Rice AR rice Aerial 247 1.90 201000 246 0.39 0.04 21.8

Rice AR rice Aerial 245 1.88 201000 245 0.39 0.04 21.7

Rice CA rice Aerial 295 2.27 241000 295 0.46 0.04 26.1

Rice CA rice Aerial 294 2.26 241000 294 0. 46 0.04 26.0

Rice LA rice Aerial 225 1.73 183000 224 0.35 0.03 19.8

Rice MS rice Aerial 233 1.79 188000 230 0.36 0.03 20.4

Rice TX rice Aerial 263 2.02 214000 262 0.41 0.04 23.2

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Based on peak pore water EEC divided by 130 ug a.i/L (EC 50 value of most sensitive estuarine/marine water column invertebrate)

3 Based on 21

- day organic carbon (OC)

- normalized sediment EECs divided by OC

- normalized NOAEC of Leptocheirus plumulosus (MRID 48802201 ) of 519 000 μg a.i/kg sediment.

4 Based on 21

- day pore water EECs divided by pore water NOAEC of Leptocheirus plumulosus (MRID 48802201 )

of 7000 μg a.i/L.

5 Based on 21

- day pore water EECs divided by 11.3 μg a.i/L (NOAEC value of most sensitive estuarine/marine

wate r column invertebrate )- Page 89 of 196

- 6 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### 4.1. 3

. RQ Values for Terrestrial Organisms

As previously discussed in Section 3.2.3 potential direct effects to terre strial species are based on foliar, airblast, ground spray, and aerial spray applications of flutolanil . Potential risks to birds and, thus, terrestrial

- phase amphibians are evaluated using T

- REX, acute and chronic toxicity

data for the most sensitive bir d species for which data are available, and the most sensitive dietary item and size class for that species. For terrestrial

- phase amphibians, the most sensitive RQ in T

- REX is for the small bird consuming small insects. For birds the most sensitive RQ i n
T

- REX is for the small bird consuming short grass

. The specific EECs for each species are for the same size birds and same dietary items as those considered for acute exposure. Chronic effects are estimated using the lowest available NOAEC from a chron ic study for birds, amphibians, and reptiles. Dietary

- based EECs are divided by toxicity values to estimate chronic dietary

- based RQs.

The acute dietary

- based RQs for birds, reptiles and terrestrial

- phase and amphibians derived using T

- REX are shown in Table 4. 7

. The RQs in Table 4. 7 are expressed as being “less than,” values due to the fact that they are based on a non

- definitive “greater than,” LC 50 

### estimate s

. While there is uncertainty in estimating risk from a non

- d efinitive endpoint, even these up per bound RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ

would be at most

.

The available acute oral toxicity study did not determine a definitive L D 50 

### as there were no

mortalities observed up t o and including the highest treatment group (2000 mg a.i.kg

- bw)

. Despite a LD 50 

### not being achieved , some use modeled in T

- REX estimate flutolanil residues several fold higher than the available toxicity study tested up to. While it cannot be definitively

stated that there is a true LOC exceedance for acute dose

- based risk to birds, some uses indicate

the potential to exceed an acute LOC based on the fact that the true LD 50 

### could lie anywhere above the 2000 mg a.i/kg

- bw threshold.

Similarly , for acute dietary

- based risk to birds, some uses indicate a potential to exceed the acute LOC despite there being no mortality effects up to treatment concentrations of >5243 mg a.i/kg

diet. Uses that have the potential to exceed the LOC are a result of uses that have repeated applicati ons and the presence of residues greater than the highest concentration tested in the dietary study to be available.

Chronic dietary

- based RQs are tabulated in Table 4. 8

. These RQs were determined using

definitive NOAEC values from available avian repr oduction studies. There were 6 of 11 (55%) flutolanil uses that exceeded the dietary

- based chronic LOC for at least one food item. As the available avian reproduction data show that a definitive NOAEC was determined, these exceedances have more certainty the acute RQs discussed earlier.

Table 4. 7

. Acute Dietary

- Based RQs for Birds, Reptiles, and Terrestrial

- phase Amphibians of Different Feeding Classes (T

- REX v. 1.5

. 2 ). 1,2 

### (Note: As a definitive acute dietary LC 50 

### was not achieved for birds, “>”, all RQ s presented in this table are preceded- Page 90 of 196

- 

### with a “<.” )
Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Food crops

Bra ssica (Cole) Leafy Vegetables , plus Turnip

Greens 0.04 0.02 0.02 <0.01 0.01

Peanuts (0.95 lb a.i/A , 1X ) 0.04 0.02 0.02 <0.01 0.02

Peanuts (0.475 lb a.i/ A, 4X) 0.07 0.03 0.04 <0.01 0.03

Peanuts (0.95 lb a.i, 2X) 0.07 0.03 0.04 <0.01 0.03

Peanuts (2 l bs a.i/A) 0.09 0.04 0.05 0.01 0.04

Peanuts (1 lb a.i/A, 2X) 0.07 0.03 0.04 <0.01 0.03

Peanuts (0.5 lbs a.i/A, 4x) 0.07 0.03 0.04 <0.01 0.03

Peanuts (0.74 lbs a.i/A, 1X) 0.03 0.02 0.02 <0.01 0.01

Potatoes 0.04 0.02 0.02 <0.01 0.01

Rice (0.980 lbs a.i/ A, 1X) 0.04 0.02 0.03 <0.01 0.02

Rice (0.490 lbs a.i/A, 2X) 0.04 0.02 0.02 <0.01 0.02

Turf Uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas < 0.69 < 0.32 < 0.39 0.04 < 0.27

Golf course greens, tee s, and aprons < 1.21 < 0.56 < 0.68 0.08 < 0.48

Golf course fairways (all states but FL) < 0.45 < 0.20 < 0.25 0.03 < 0.18

Golf course fairways (only in FL) < 0.22 < 0.10 < 0.13 0.01 0.09

Ornamental lawns and turf; recreation area lawns, residential lawns < 0.62 < 0.2 8 < 0.35 0.04 < 0.24

Commercial and industrial lawns < 0.75 < 0.34 < 0.42 0.05 < 0.29

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock, ornamentals & fruits (unspecified) (9.78 lbs a.i/A, 4X) < 1.36 < 0.62 < 0.77 0.09 < 0.53

Nursery stock, o rnamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) < 0.17 0.08 < 0.10 0.01 0.07

1 Italacized cells indicate that the RQ has the potential to exceed an LOC for acute risk to listed and nonlisted birds

. See risk description section for more information.

2 A cute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5- Page 91 of 196

- 

### Table 4. 8 . Chronic Dietary

- Based RQs for Birds , Reptiles, and Terrestrial

- phase Amphibians of Different Feeding Classes (T

- REX v. 1.5

. 2 )

. 1

Primary Feeding Strate gy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 0.10 0.04 0.05 0.01 0.0 4

Peanuts (0.95 lb a.i/A , 1X ) 0.12 0.05 0.07 0.01 0.05

Peanuts (0.475 lb a.i/ A, 4X) 0.18 0.08 0.10 0.01 0.07

Peanuts (0.95 lb a.i, 2X) 0.20 0.09 0.11 0.01 0.08

Peanuts (2 lbs a.i/A) 0.25 0.11 0.14 0.02 0.10

Peanuts (1 lb a.i/A, 2X) 0.19 0.09 0.11 0. 01 0.08

Peanuts (0.5 lbs a.i/A, 4x) 0.19 0.09 0.11 0.01 0.07

Peanuts (0.74 lbs a.i/A, 1X) 0.09 0.04 0.05 0.01 0.04

Potatoes 0.10 0.04 0.05 0.01 0.04

Rice (0.980 lbs a.i/A, 1X) 0.12 0.06 0.07 0.01 0.05

Rice (0.490 lbs a.i/A , 2X) 0.11 0.05 0.06 0.01 0. 04

Turf Uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 1.89 0.87 1.06 0.12 0.74

Golf course greens, tees, and aprons 3.31 1.52 1.86 0.21 1.30

Golf course fairways (all states but FL) 1.22 0. 56 0.69 0.08 0.48

Golf course fairways (only in FL) 0.61 0.28 0.34 0.04 0.24

Ornamental lawns and turf; recreation area lawns, residential lawns 1.69 0.78 0.95 0.11 0.66

Commercial and industrial lawns 2.05 0.94 1.16 0.13 0.80

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock, ornamentals & fruits (unspecified) (9.78 lbs a.i/A, 4X) 3.72 1.71 2.09 0.23 1.46

Nursery stock, ornamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) 0.46 0.21 0.26 0.03 0.18

1 Bolded and shaded cells indic ate that the RQ exceeds the LOC for chronic risk to listed and nonlisted birds (LOC = 1).



### The acute dose

- based RQs for birds, reptiles and terrestrial

- phase amphibians derived using T

REX are shown in Table 4. 9

. The RQs in Table 4. 9 are expressed as bei ng “less than,” values due to the fact that they are based on a non

- definitive “greater than,” L D 50 

### estimate s . While there is uncertainty in estimating risk from a non

- d efinitive endpoint, even these upper bound RQs can be thought of as a “worst case,” sc enario of risk as they represent what the RQ would be- Page 92 of 196

- 

### at most

. There were 10 of 11 ( 91 %) of flutolanil uses that resulted in the exceedance of at least one acute LOC for at least one size class of birds consuming flutolanil contaminated food items

.- Page 93 of 196

- 

### T able 4. 9 . Acute Dose

- based RQ values for Birds Exposed to Flutolanil (T

- REX v. 1.5. 2 ). 1 ,2,3 

### (Note: As a definitive acute oral

LD 50 

### was not achieved for birds, “>”, all RQs presented in this table are preceded with a “<.”
Primary Feeding Strategy  Herbivo res and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Food crops

B rassica (Cole) Leafy Vegetables , plus Turnip Greens < 0.15 0.07 0.08 0.01 0.07 0.03 0.04 <0.01 0.02 0.01 0.01 <0.01 0.06 0.03 0.01 <0.01 <0.0 1 <0.01

Peanuts (0.95 lb

a.i/A , 1X ) < 0.18 0.08 < 0.10 0.01 0.08 0.04 0.05 0.01 0.03 0.01 0.01 <0.01 0.07 0.03 0.01 <0.01 <0.01 <0.01

Peanuts (0.475 lb a.i/ A, 4X) < 0.27 < 0.13 < 0.15 0.02 < 0.12 0.06 0.07 0.01 0.04 0.02 0.02 <0.01 < 0.11 0.05 0.02 <0.01 <0.0 1 <0.01

Peanuts (0.95 lb a.i, 2X) < 0.30 < 0.14 < 0.17 0.02 < 0.13 0.06 0.08 0.01 0.04 0.02 0.02 <0.01 < 0.12 0.05 0.02 <0.01 <0.01 <0.01

Peanuts (2 lbs a.i/A) < 0.38 < 0.17 < 0.21 0.02 < 0.17 0.08 < 0.10 0.01 0.05 0.02 0.03 <0.01 < 0.15 0.07 0.02 0.01 <0.01 <0.01

Peanuts (1 lb a.i/A, 2X) < 0.29 < 0.13 < 0.17 0.02 < 0.13 0.06 0.07 0.01 0.04 0.02 0.02 <0.01 < 0.12 0.05 0.02 <0.01 <0.01 <0.01

Peanuts (0.5 lbs a.i/A, 4x) < 0.29 < 0.13 < 0.16 0.02 < 0.13 0.06 0.07 0.01 0.04 0.02 0.02 <0.01 < 0.11 0.05 0.02 <0.01 <0.01 <0.01

Pe anuts (0.74 lbs a.i/A, 1X) < 0.14 0.06 0.08 0.01 0.06 0.03 0.04 <0.01 0.02 0.01 0.01 <0.01 0.06 0.02 0.01 <0.01 <0.01 <0.01

Potatoes < 0.15 0.07 0.08 0.01 0.07 0.03 0.04 <0.01 0.02 0.01 0.01 <0.01 0.06 0.03 0.01 <0.01 <0.01 <0.01

Rice (0.980 lbs a.i/A, 1X ) < 0.19 0.09 < 0.10 0.01 0.08 0.04 0.05 0.01 0.03 0.01 0.01 0.00 0.07 0.03 0.01 0.00 0.00 0.00

Rice (0.490 lbs a.i/A, 2X) < 0.17 0.08 < 0.10 0.01 0.08 0.03 0.04 0.00 0.02 0.01 0.01 0.00 0.07 0.03 0.01 0.00 0.00 0.00

Turf uses

Turf (golf courses, sod < 2.87 < 1.31 < 1.61 < 0.18 < 1.28 < 0.59 < 0.72 0.08 < 0.41 < 0.19 < 0.23 0.03 < 1.12 < 0.50 < 0.16 0.04 0.02 0.01- Page 94 of 196

- Primary Feeding Strategy  Herbivo res and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

farms, spot fields, residential, institutional, municipal, and

commercial areas Golf course greens, tees, and

aprons < 5.03 < 2.31 < 2.83 < 0.31 < 2.25 < 1.03 < 1.27 < 0.14 < 0.71 < 0.33 < 0.40 0.04 < 1.97 < 0.88 < 0.28 0.07 0.03 0.01

Golf course fairways (all states but FL) < 1.85 < 0.85 < 1.04 < 0.12 < 0.83 < 0.38 < 0.47 0.05 < 0.26 < 0.12 < 0.15 0.02 < 0.73 < 0.33 < 0.10 0.03 0.01 <0.01

Golf course fairways (only in FL) < 0.93 < 0.42 < 0.52 0.06 < 0.41 < 0.19 < 0.23 0.03 < 0.13 0.06 0.07 0.01 < 0.36 < 0.16 0.05 0.01 0.01 <0.01

Ornamental lawns and turf;

recreation area lawns, residential

lawns < 2.57 < 1.18 < 1.44 < 0.16 < 1.15 < 0.53 < 0.65 0.07 < 0.36 < 0.17 < 0.21 0.02 < 1.01 < 0.45 < 0.14 0.04 0.02 0 .01

Commercial and

industrial lawns < 3.12 < 1.43 < 1.75 < 0.19 < 1.40 < 0.64 < 0.79 0.09 < 0.44 < 0.20 < 0.25 0.03 < 1.22 < 0.55 < 0.17 0.04 0.02 0.01

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock,

ornamentals &

fruits (unspecified) (9.78 lb s a.i/A, 4X) < 5.65 < 2.59 < 3.18 < 0.35 < 2.53 < 1.16 < 1.42 < 0.16 < 0.80 < 0.37 < 0.45 0.05 < 2.21 < 0.99 < 0.31 0.08 0.04 0.01

Nursery stock,

ornamentals &

fruits < 0.70 < 0.32 < 0.39 0.04 < 0.31 < 0.14 < 0.18 0.02 < 0.10 0.05 0.06 0.01 < 0.27 < 0.12 0.04 0.01 <0.01 <0.01- Page 95 of 196

- Primary Feeding Strategy  Herbivo res and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

(unspecified) (2.1

lbs a.i/A, 2X)

1 Italicized cells indicate that the RQ as the potential to exceed an LOC for acute risk to listed and nonlisted bird . See Risk Description section more for more

information.

2 Using adjusted LD 50 values of 1283, 1634, and 2 308 for small , medium, and large birds, respectively.

3 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5- Page 96 of 196

- 

### Potential risks to mammals are evaluated using T

- REX, acute and chronic toxic ity data for laboratory ra t s
, and the most sensitive dietary item and size class for that species. For mammals the most sensitive RQ in T

- REX is for the small mammal consuming short grass. The specific EECs for each species are for the same size mammals and same dietary items as tho se considered for acute exposure. Chronic effects are estimated using the lowest available NOAEC from a chronic study for mammals . Dietary

- based EECs are divided by toxicity values to estimate chronic dietary

- based RQs.

The acute and chronic dose

- based and dietary

- based RQs for mammals are tabulated below in

Table s 4. 10

, 4. 1 1 , and 4. 12

, respectively

. The RQs in Table 4. 10

, Table 4. 1 1 , and Table 4. 12 are expressed as being “less than,” values due to the fact that they are based on a non

- definitive “gre ater than,” L D 50 

### and NOAEL estimate s , respectively . While there is uncertainty in estimating risk from a non

- d efinitive endpoint, even these upper bound RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ would be at mo st

.

The available acute oral toxicity study for mammals did not determine a definitive LD 50 

### as there

were no mortalities observed up to and including the highest treatment group (10000 mg a.i/kg

bw). Despite a LD 50 

### not being achieved , some uses modeled in T

- REX estimate flutolanil residues several fold higher than the available toxicity study tested up to (when repeated applications and the persistence of flutolanil are taken into account ; e.g. 8141 mg a.i/kg

- bw for a small bird eating short grass in the a nursery stock scenario ) . While it cannot be definitively

stated that there is a true LOC exceedance for acute dose

- based risk to mammals , some uses indicate the potential to exceed an acute LOC based on the fact that the true LD 50 

### could lie anywhere ab ove the 10000 mg a.i/kg

- bw threshold.

Similarly , for chronic dose and dietary

- based risk to birds, some uses indicate a potential to
exceed the chronic LOC despite there being no effects up to treatment concentrations of 20,000 mg a.i/kg

- diet, equivalent to 1936 mg a.i/kg

- diet. Uses that have the potential to exceed the LOC are a result of uses that have repeated applications and the presence of residues greater than the high est concentration tested in the chronic study to be available.

Chronic dose

- base d RQs are tabulated in Table 4. 1 1

. Chronic dietary

- based RQs are presented

in Table 4. 1 2

. There were no uses of flutolanil that had the potential to exceed the chronic LOC when expressed as dietary

- based RQs.- Page 97 of 196

- 

### Table 4. 1 0

. Acute Dose

- based RQ values f or Mammals Exposed to Flutolanil (T

- REX v. 1. 5

. 2 ) 1 ,2,3 

### (Note: As a definitive acute

oral LD 50 

### was not achieved for mammals, “>”, all RQs presented in this table are preceded with a“<.”
Primary Feeding Strategy  Herbivores and Omnivores Insectivores Graniv ores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 0.01 <0.01 <0.01 <0.01 0.01 0.00 0.00 <0.01 0.00 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (0.95 lb

a.i /A , 1X ) 0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.00 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (0.475 lb a.i/ A, 4X) 0.02 <0.01 <0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01

Peanuts ( 0.95 lb a.i, 2X) 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (2 lbs a.i/A) 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 0.01 <0.01 0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (1 lb

a.i/ A, 2X) 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (0.5 lbs a.i/A, 4x) 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01

Peanuts (0.74 lbs

a.i /A, 1X) 0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.00 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Potatoes 0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 <0.01 0.00 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Rice (0.980 lbs a.i/A, 1X) 0.01 <0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Rice (0.490 lbs a.i/A, 2X) 0.01 <0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Turf uses

Turf (golf courses, sod < 0.16 0.07 0.09 0.01 < 0.13 0.06 0.08 0.01 0.07 0.03 0.04 <0.01 0.06 0.05 0.03 <0.01 <0.01 <0.01- Page 98 of 196

- Primary Feeding Strategy  Herbivores and Omnivores Insectivores Graniv ores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

farms, spot fields, residential, institutional, municipal, and

commercial areas Golf course greens, tees, and

aprons < 0.28 < 0.13 < 0.16 0.02 < 0.24 < 0.11 < 0.13 0.01 < 0.13 0.06 0.07 <0.01 < 0.11 0.09 0.05 <0.01 <0.01 <0.01

Golf course fairways (all states but FL) < 0.10 0.05 0.06 0.01 0.09 0.04 0.05 0.01 0.05 0.02 0.03 <0.01 0.04 0.03 0.02 <0.01 <0.01 <0.01

Golf course fairways (only in FL) 0.05 0.02 0.03 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Ornamental lawns and turf;

recreation area lawns, residential

lawns < 0.14 0.06 0.08 0.01 < 0.12 0.06 0.07 <0.01 0.06 0.03 0.04 <0.01 0.06 0.05 0.03 <0.01 <0.01 <0.01

Commercial and

industrial lawns < 0.17 0.08 < 0.10 0.01 < 0.15 0.07 0.08 <0.01 0.08 0.04 0.04 <0.01 0.07 0.06 0.03 <0.01 <0.01 <0.01

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock,

ornamentals &

fruits (unspecified) (9.78 lbs a.i/A, 4X) < 0.31 < 0.14 < 0.17 0.02 < 0.26 < 0.12 < 0.15 0.02 < 0.14 0.07 0.08 0.01 < 0.12 < 0.10 0.06 <0.01 <0.01 <0.01

Nursery stock,

ornamentals &

fruits 0.04 0.02 0.02 <0.01 0.03 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01- Page 99 of 196

- Primary Feeding Strategy  Herbivores and Omnivores Insectivores Graniv ores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

(unspecified) (2.1

lbs a.i/A, 2X)

1 Italacized cells indicate that the RQ has the potential to exceed an LOC for acute risk to listed and nonlisted mammals . Se Risk Description section for more

information.

2 Using adjusted LD 50 values of 9011

, 7291 , and 3154 for small , m edium, and large mammals, respectively.

3 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5



### Table 4. 1 1

. Chronic Dose

- based RQ Values for Mammals Exposed to Flutolanil (T

- REX v.1. 5

. 2 ). 1,2,3

Primary Feeding

Stra tegy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.ShortGrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 0.04 0.02 0.02 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

Peanuts (0.95 lb a.i/A

, 1X ) 0.05 0.02 0.03 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Peanuts (0.475 lb a.i/ A, 4X) 0.08 0.04 0.04 <0.01 0.07 0.03 0.04 <0.01 0.04 0.02 0.02 <0.01 0.03 0.03 0.0 1 <0.01 <0.01 <0.01

Peanuts (0.95 lb a.i, 2X) 0.16 0.08 0.09 0.01 0.14 0.06 0.08 0.01 0.08 0.03 0.04 <0.01 0.06 0.05 0.03 <0.01 <0.01 <0.01- Page 100 of 196

- Primary Feeding

Stra tegy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.ShortGrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Peanuts (2 lbs a.i/A) 0.11 0.05 0.06 0.01 0.09 0.04 0.05 0.01 0.05 0.02 0.03 <0.01 0.04 0.04 0.02 <0.01 <0.01 <0.0 1

Peanuts (1 lb a.i/A, 2X) 0.08 0.04 0.05 0.01 0.07 0.03 0.04 <0.01 0.04 0.02 0.02 <0.01 0.03 0.03 0.01 <0.01 <0.01 <0.01

Peanuts (0.5 lbs a.i/A, 4x) 0.08 0.04 0.05 0.01 0.07 0.03 0.04 <0.01 0.04 0.02 0.02 <0.01 0.03 0.03 0.01 <0.01 <0.01 <0.01

Peanuts (0.74 lbs a.i/A, 1X) 0.04 0.02 0.02 <0.01 0.03 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

Potatoes 0.04 0.02 0.02 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

Rice (0.980 lbs a.i/A, 1X) 0.05 0.02 0.03 <0.01 0.05 0.02 0.03 <0.01 0.02 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Rice (0.490 lbs a.i/A, 2X) 0.05 0.02 0.03 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.02 0.01 <0.01 <0.01 <0.01

Turf uses

Turf (golf courses, sod

farm s, spot fields, residential, institutional, municipal, and

commercial areas 0.81 0.37 0.46 0.05 0.69 0.32 0.39 0.04 0.37 0.17 0.21 0.02 0.32 0.27 0.15 0.01 0.01 0.01

Golf course greens, tees, and aprons < 1.43 0.65 0.80 0.09 < 1.22 0.56 0.69 0.08 0.65 0.30 0.37 0.04 0.56 0.48 0.26 0.02 0.02 0.01

Golf course fairways (all states but FL) 0.53 0.24 0.30 0.03 0.45 0.21 0.25 0.03 0.24 0.11 0.14 0.02 0.21 0.18 0.09 0.01 0.01 <0.01

Golf course fairways (only in FL) 0.26 0.12 0.15 0.02 0.22 0.10 0.13 0.01 0.12 0.0 6 0.07 0.01 0.10 0.09 0.05 <0.01 <0.01 <0.01

Ornamental lawns and turf; recreation area lawns, residential

lawns 0.73 0.33 0.41 0.05 0.62 0.28 0.35 0.04 0.33 0.15 0.19 0.02 0.29 0.24 0.13 0.01 0.01 <0.01

Commercial and

industrial lawns 0.88 0.41 0.50 0.0 6 0.76 0.35 0.42 0.05 0.40 0.19 0.23 0.03 0.35 0.30 0.16 0.01 0.01 <0.01- Page 101 of 196

- Primary Feeding

Stra tegy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.ShortGrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.

Arthropods Seeds, grains, etc

. Use(s) 

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock,

ornamentals & fruits (unspecified) (9.78 lbs a.i/A, 4X) < 3.10 < 1.42 < 1.74 0.19 < 2.65 < 1.21 < 1.49 0.17 < 1.42 0. 65 0.80 0.09 < 1.21 < 1.04 0.56 0.04 0.04 0.02

Nursery stock,

ornamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) 0.38 0.18 0.22 0.02 0.33 0.15 0.18 0.02 0.18 0.08 0.10 0.01 0.15 0.13 0.07 0.01 <0.01 <0.01

1 Italacized cells indicate that the RQ has the potential to exceed an LOC for acute risk to listed and nonlisted mammals

. Se Risk Description section for more

information.

2 Using adjusted NOAEL values of 23.30

, 18.85 , and 8.15 for small , medium, and large mammals, respectively.

3 Chronic risk LOC = 1.- Page 102 of 1 96

- 

### Table 4. 1 2

. Chronic Dietary

- Based RQs for Mammals of Exposed to Flutolanil (T

- REX

v.1.5 .2 ). 1,2

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short Grass Tall Grass Broad

- leaf

Plants Fruits, pods, seeds,

e tc

. Arthropods

Use(s) 

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip

Greens 0.01 <0.01 0.01 <0.01 <0.01

Peanuts (0.95 lb a.i/A , 1X ) 0.01 0.01 0.01 <0.01 <0.01

Peanuts (0.475 lb a.i/ A, 4X) 0.02 0.01 0.01 <0.01 0.01

Peanuts (0.95 lb a.i, 2X) 0.02 0.01 0.01 <0.01 0.01

Peanuts (2 lbs a.i/A) 0.02 0.01 0.01 <0.01 0.01

Peanuts (1 lb a.i/A, 2X) 0.02 0.01 0.01 <0.01 0.01

Peanuts (0.5 lbs a.i/A, 4x) 0.02 0.01 0.01 <0.01 0.01

Peanuts (0.74 lbs a.i/A, 1X) 0.01 <0.01 0.01 <0.01 <0.01

Potat oes 0.01 <0.01 0.01 <0.01 <0.01

Rice (0.980 lbs a.i/A, 1X) 0.01 0.01 0.01 <0.01 <0.01

Rice (0.490 lbs a.i/A, 2X) 0.01 <0.01 0.01 <0.01 <0.01

Turf Uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial ar eas 0.18 0.08 0.10 0.01 0.07

Golf course greens, tees, and aprons 0.32 0.15 0.18 0.02 0.12

Golf course fairways (all states but FL) 0.12 0.05 0.07 0.01 0.05

Golf course fairways (only in FL) 0.06 0.03 0.03 <0.01 0.02

Ornamental lawns and turf; recreati on area lawns, residential lawns 0.16 0.07 0.09 0.01 0.06

Commercial and industrial lawns 0.20 0.09 0.11 0.01 0.08

Nursery stock ornamentals and fruit s (unspecified) uses
Nursery stock, ornamentals & fruits (unspecified) (9.78 lbs a.i/A, 4X) 0.36 0.16 0 .20 0.02 0.14

Nursery stock, ornamentals & fruits (unspecified) (2.1 lbs a.i/A, 2X) 0.04 0.02 0.02 <0.01 0.02

1 Bolded and shaded cells indicate that the RQ exceeds an LOC for acute risk to listed and nonlisted mammals.

2 Chronic risk LOC = 1 , NOAEL used f or RQ estimation was 20,000 ppm.- Page 103 of 196

- 

### Table 4. 1 3 summarizes the acute and chronic RQs for birds and mammals resulting from the seed treatment uses of flutolanil. For the avian acute and mammalian acute and chronic RQs,

non

- definit i ve ( i.e. “>”) endpoint s were used in the risk estimation and therefore the resultant RQs are preceded with an “<,” that represent an upper bound, “worst case,” scenario of risk.

There was no acute or chronic risk above the LOC indicated fo r bird and mammals resulting

from the seed treatment uses of flutolanil.- Page 104 of 196

- 

### Table 4. 13 . Acute and Chronic RQs for Birds and Mammals Resulting from Seed

- Treatment uses of Flutolanil 1

Use Birds Mammals

Acute

Chronic Acute

Chronic Small Medium Large Small Medium Large RQ1 RQ2 RQ1 RQ2 RQ1 RQ2 RQ1 RQ2 RQ1 RQ2 RQ1 RQ2

Cotton 0.08 <0.01 0.04 <0.01 0.01 <0.01 0.25 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 Small 0.02

Medium 0.02

Large 0.01

Soybean 0.08 0.03 0.04 <0.01 0.01 <0.01 0.25 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 Small 0.02

Medium 0.02

Large 0.01

Sugarbeet 0.08 <0.01 0.04 <0.01 0.01 <0.01 0.25 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 Small 0.02

Medium 0.02

Large 0.01

Potato <0.01 0.02 <0.01 <0.01 <0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 Small <0.01

Medium <0.01

Large <0.01 RQ#1 = mg a.i/kg

- bw

- day/LD 50 RQ#2 = mg a.i ft 2 /(LD 50 *bw) Avian chronic RQ = mg kg

- 1 seed/NOAEL Mammalian chronic = mg a.i/kg

- bw/day/adjusted NOAEL

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5; chronic LOC = 1- Page 105 of 196

- 

### Risk to terrestrial plants in dry areas and semi

- aquatic areas resulting from runoff and spray drift

of flutolanil was estimated using th e TerrPlant (v.1.2.2) model. The TerrPlant derived EECs are compared to the most sensitive monocot and dicot EC 25 

### to generate a non

- listed species RQ and compared to the most sensitive NOAEC or EC 05 

### to generate a listed species RQ. The listed and

non

- lis ted terrestrial plant LOC is 1. For vegetative vigor, the most sensitive monocot was ryegrass based on significant effects on weight at all concentrations. An EC 25 

### and NOAEC was therefore not able to be established definitively and so risk to listed mono cots resulting from spray drift was not able to be assessed. For dicots, there was not a most sensitive species determined based on lack of toxicity and therefore the EC 25 

### was a “>” value

. Consequently, all nonlisted dicots RQs in Table 4. 1 5 in the spray drift only estimates will be preceded by a “<.

All endpoints from the seedling emergence study were definitive.

Table 4. 14 . RQs for Nontarget Monocots Adjacent to Flutolanil Use Areas 1

Crop Single Max. Application

Rate (lbs ai /A) Monocot RQ Values

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species Nonlisted Species Listed Species

Food crops

Brassica (Cole) Leafy Vegetables , plus

T urnip Greens 0.772 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (ground) 0.475 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (aerial or chemigation) 0.475 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (ground) 0.5 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (aerial or chemigation) 0.5 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts 1 0.742 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (ground) 0.95 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (aerial or chemigation) 0.95 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (ground) 1.0 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (aerial or chemigation) 1.0 < 0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (ground) 2.0 <0.1 <0.1 <0.1 <0.1 0.10

Peanuts (aerial or chemigation) 2.0 <0.1 <0.1 <0.1 <0.1 0.14

Potatoes 2 0.77 <0.1 <0.1 <0.1 <0.1 <0.1

Rice (aerial) 0.980 <0.1 <0.1 <0.1 <0.1 <0.1

Rice (aerial) 0.490 <0.1 <0.1 <0.1 <0.1 <0.1

Rice (ground) 0.980 <0.1 <0.1 <0.1 <0. 1 <0.1

Rice (ground) 0.490 <0.1 <0.1 <0.1 <0.1 <0.1- Page 106 of 196

- Crop Single Max. Application

Rate (lbs ai /A) Monocot RQ Values

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species Nonlisted Species Listed Species

Turf uses

Turf (golf courses, sod farms, spot fields, residential, institutional, municipal, and

commercial areas 8.6 0.12 0.14 0.23 0.35 0.59

Golf course greens, tees, and aprons 8.56 0.12 0.14 0.23 0.35 0.58

Golf course fairways (all states but FL) 9.77 0.13 0.16 0.27 0.40 0.67

Golf course fairways (only in FL) 4.88 <0. 1 <0. 1 0.13 0.20 0.33

Ornamental lawns and turf; recreation area

lawn s, residential

lawns 4.94 0.1 <0.1 0.13 0.20 0.3 4

Commercial and

industrial lawns 5.94 <0.1 <0.1 0.16 0.24 0.41

Nursery stock ornamentals and fruit s (unspecified) uses

Nursery stock,

ornament als & fruits (unspecified) 9.78 0.13 0.16 0.27 0.40 0.67

Nursery stock,

ornamentals & fruits (unspecified) 2.10 <0.1 <0.1 <0.1 <0.1 0.14

N/D = Not determined

1 LOC for listed and non

- listed species = 1



### Table 4. 1 5 . RQs for Nontarget Dicot Ad jacent to Flutolanil Use Areas 1

Crop Single Max. Application

Rate (lbs ai /A) Dicot RQ Values 2

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species Nonlisted Species Listed Species

Food crops

Brassica (Cole) Leafy Vegetables , plus Turnip Greens 0.772 <0.1 <0.1 <0.1 <0.1 <0.1 0.16

Peanuts (ground) 0.475 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

Peanuts (aerial or chemigation) 0.475 <0.1 <0.1 <0.1 <0.1 <0.1 0.13

Peanuts (ground) 0.5 <0.1 <0.1 <0.1 <0.1 <0.1 0.1

Peanut s (aerial or chemigation) 0.5 <0.1 <0.1 <0.1 <0.1 <0.1 0.14

Peanuts 1 0.742 <0.1 <0.1 <0.1 <0.1 <0.1 0.15- Page 107 of 196

- Crop Single Max. Application

Rate (lbs ai /A) Dicot RQ Values 2

Spray Drift Only Runoff and Spray Drift ( Dry Areas ) Runoff and Spray Drift ( Semi

- Aquatic Areas )

Nonlisted

Species Listed Species Nonlisted Species Listed Species Nonlisted Species Listed Species

Peanuts (ground) 0.95 <0.1 <0.1 <0.1 <0.1 <0.1 0.19

Peanuts (aerial or chemigation) 0.95 <0.1 <0.1 <0.1 0.11 <0.1 0.26

Peanuts (ground) 1.0 <0.1 <0 .1 <0.1 <0.1 <0.1 0.20

Peanuts (aerial or chemigation) 1.0 <0.1 <0.1 <0.1 0.11 0.10 0.28

Peanuts (ground) 2.0 <0.1 <0.1 <0.1 <0.1 0.15 0.41

Peanuts (aerial or chemigation) 2.0 <0.01 0.19 <0.1 0.22 0.21 0.56

Potatoes 2 0.77 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

Rice (aerial) 0.980 <0.1 <0.1 <0.1 0.11 0.10 0.27

Rice (aerial) 0.490 <0.1 <0.1 <0.1 <0.1 <0.1 0.14

Rice (ground) 0.980 <0.1 <0.1 <0.1 <0.1 <0.1 0.20

Rice (ground) 0.490 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

Turf uses

Turf (golf courses, sod farms, spot fiel ds, residential, institutional, municipal, and

commercial areas 8.6 0.30 0.80 0.36 0.96 0.89 2.39

Golf course greens, tees, and aprons 8.56 0.30 0.79 0.35 0.95 0.89 2.38

Golf course fairways (all states but FL) 9.77 0.34 0.90 0.40 1.09 1.01 2.71

Golf co urse fairways (only in FL) 4.88 0.17 0.45 0.20 0.54 0.50 1.36

Ornamental lawns and turf; recreation area lawns, residential

lawns 4.94 0.17 0.46 0.20 0.55 0.51 1.37

Commercial and

industrial lawns 5.94 0.20 0.55 0.25 0.66 0.61 1.65

Nursery stock ornamen tals and fruit s (unspecified) uses

Nursery stock,

ornament als & fruits (unspecified) 9.78 0.34 0.91 0.40 1.09 1.01 2.72

Nursery stock,

ornamen tals & fruits (unspecified) 2.10 <0.01 0.19 <0.1 0.23 0.22 0.58

N/D = Not determined

1 LOC for listed and non

- li sted species = 1- Page 108 of 196

- 

### 4.1.4. Bioaccumulation Analysis Results

KABAM was used to calculate risk quotients from a bioaccumulation pathway for food items that may be consumed by birds and mammals for the modeled scenarios of flutolanil. ( Table

4. 16

– 4. 20 ). There were no scenarios that resulted in RQs that exceeded the chronic LOC for dose or dietary based risk to birds or mammals. For the scenario that resulted in the highest exposure (nursery stock, NJ nursery scenario, soil drench application), there we re acute LOCs for mammals exceeded, however for birds there were two species exceeding all acute LOCs for dose based risk (sandpipers and rails), and all avian species exceeded the acute endangered species LOC with one species meeting the acute restricted use LOC. The nursery stock scenario as a ground spray application and the rice scenario as an aerial application similarly had acute

dose based exceedances of one or more acute LOC for birds for sandpipers and rails but no dietary based risk above the LOC was indicated. There were no acute LOC exceedances for the turf or peanut scenarios.

It is important to note that all acute avian and mammalian RQ s are estimated using a non

definitive endpoint, that is a “>” value in which an LD 50 

### /LC 50 

### was not achieved and therefore are preceded with a “<”. As with the acute avian and mammalian RQs, as non

- definitive endpoints were reached in these studies, RQs indicated as having the potential to exceed the

acute LOC are indicated with italics. Further details can be found in the risk description section.

Table 4. 1 6 . Summary of RQ Values f or Mammals and Birds C onsuming F ish

C ontaminated by Flu tolanil Resulting from the Soil Drench Use on Nursery Stock 1 ,2

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew < 0.03 0.30 0.05

Rice rat/star nosed

mole < 0.03 0.32 0.0 5

Small mink < 0.03 0.25 0.04 Large mink < 0.03 0.2 8 0.04

Small river otter < 0.03 0.30 0.04 Large river otter < 0.02 0.21 0.0 3

Avian Sandpipers < 0.9 5 < 0.18 0.49

Cranes < 0.0 5 < 0.1 7 0.45

Rails < 0.49 < 0.20 0.5 6

Herons < 0.0 7 < 0.18 0.49 Small osprey < 0.08 < 0.15 0.4 2 White pelican < 0.02 < 0.10 0.2 8 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acu te high risk LOC = 0.5; chronic risk LOC

=1.

2 RQs having the potential to exceed the acute LOC are indicated with italics. Further information in the risk description section.- Page 109 of 196

- 

### Table 4. 1 7 . Summary of RQ Values for Mammals and Birds Consuming Fish

Conta minated by Flutolanil Resulting from the Ground Spray Use on Nursery Stock 1 ,2

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew < 0.01 0.14 0.0 3

Rice rat/star nosed

mole < 0.0 2 0.15 0.02

Small mink < 0.01 0.1 2 0.0 2 Large mink < 0.01 0.1 3 0.0 2

Small river otter < 0.01 0.1 4 0.0 2 Large river otter < 0.01 0. 10 0.01

Avian Sandpipers < 0.44 < 0.08 0.2 3

Cranes < 0.02 < 0.08 0.2 1

Rails < 0.2 3 < 0.09 0.2 6

Herons < 0.03 < 0.08 0.2 3 Small osprey < 0.0 4 < 0.07 0.19 White pelican < 0.01 < 0.0 5 0.1 3 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5; chronic risk LOC

=1.

2 RQs having the potential to exceed the acute LOC are indicated with i talics. Further information in the risk description section.



### Table 4. 1 8 . Summary of RQ Values for Mammals and Birds Consuming Fish Contaminated by Flutolanil Resulting from the Ground Spray use on Golf Courses 1

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew < 0.0 1 0.01 < 0.0 1

Rice rat/star nosed

mole < 0.0 1 0.0 2 < 0.0 1

Small mink < 0.0 1 0.01 < 0.0 1 Large mink < 0.0 1 0.01 < 0.0 1

Small river otter < 0.0 1 0.01 < 0.0 1 Large river otter < 0.0 1 0.0 1 < 0.0 1

Avian Sandpipers < 0.04 < 0.0 1 0.02

Cranes < 0.0 1 < 0.0 1 0.02

Rails < 0.02 < 0.0 1 0.0 3

Herons < 0.0 1 < 0.0 1 0.02 Small osprey < 0.0 1 < 0.0 1 0.0 2 White pelican < 0.0 1 < 0.0 1 0.01 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute res tricted use LOC = 0.2; acute high risk LOC = 0.5; chronic risk LOC

=1.- Page 110 of 196

- 

### Table 4. 19 . Summary of RQ Values for Mammals and Birds Consuming Fish Contaminated by Flutolanil Resulting from the Aerial use on Rice 1 ,2

Wildlife Species Acute Chronic

Dose Base d Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew <0.01 0.07 0.01

Rice rat/star nosed

mole <0.01 0.0 8 0.01

Small mink <0.01 0.06 0.01 Large mink <0.01 0.0 7 0.01

Small river otter <0.01 0.07 0.01 Large river otter <0.01 0.05 <0 .01

Avian Sandpipers < 0.23 < 0.04 0.1 2

Cranes < 0.01 < 0.04 0.1 1

Rails < 0.12 < 0. 05 0.13

Herons < 0.02 < 0.04 0.1 2 Small osprey < 0.02 < 0.0 4 0.10 White pelican <0.01 < 0.0 3 0.0 7 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute restric ted use LOC = 0.2; acute high risk LOC = 0.5; chronic risk LOC

=1.

2 RQs having the potential to exceed the acute LOC are indicated with italics. Further information in the risk description section.



### Table 4. 20 . Summary of RQ Values for Mammals and Birds C onsuming Fish Contaminated by Flutolanil Resulting from the Aerial Use on Peanuts 1

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian Fog/water shrew <0.01 <0.01 <0.01

Rice rat/star nosed

mole <0.01 <0.01 <0.0 1

Small mink <0.01 <0.01 <0.01 Large mink <0.01 <0.01 <0.01

Small river otter <0.01 <0.01 <0.01 Large river otter <0.01 <0.01 <0.01

Avian Sandpipers < 0.0 3 <0.01 0.01

Cranes <0.01 <0.01 0.01

Rails < 0.01 <0.01 0.02

Herons <0.01 <0.01 0.01 Small osprey <0.01 <0.01 0.01 White pelican <0.01 <0.01 0.01 N/A = Not applicable

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5; chronic risk LOC

=1.- Page 111 of 196

- 

### 4. 2

. Risk Description

4. 2 .1. Risks to Aquatic Organis ms

Flutolanil is a persistent chemical under most dissipation pathways evaluated . It is expected to dissipate slowly mainly through aerobic soil metabolism, with half

- lives of 190

- 320 days. Further the chemical did not show any major metabolites in the laboratory studies ( < 10 % of the applied). Field dissipation studies appear to indicate that in the field various dissipation processes may occur. There are several terrestrial field dissipation studies and a long term study,

which show half

- lives of 27

- 126 days (excluding the second half

- life calculated for one of the studies for which a biphasic pattern was observed ) . Aquatic field dissipation studies yielded also a wide range of half

- lives of 63

- 303 and parent flutolanil remained mainly in the sedimen t. When flutolanil is applied to the field, it is expected to reach crop canopy (via foliar applications or translocated since it is a systemic pesticide), and the soil (through incorporation in planted seeds, or foliar applications). Flutolanil may be t ransported to surface water through erosion of soil particles containing bound flutolanil or dissolved in runoff water. It is worth noting that the

21

- day and 60

- day EEC modeled for flutolanil (all uses) are only marginally reduced from that of the peak c oncentration due to flutolanil’s persistence in the aquatic media.

4.2.1.1. Freshwater Fish and Aquatic

– Phase Amphibians

The results of this screening

- level risk assessment indicate that 3 of 10 (30%) of all assessed uses

of flutolanil have the potent ial for direct adverse effects to listed species of freshwater fish on an acute basis. There are 2 of 10 (20%) uses that have the potential for direct adverse effects to

non

- listed species of freshwater fish on an acute basis for at least one modeled scen ario. There are 5 of 10 (50%) of uses that have the potential for direct adverse effects to listed species for at

least one modeled scenario. Acute RQs for freshwater fish across all uses ranged from <0.01

– 1.88

.

T here were no ecological incidents re ported for freshwater fish resulting from the use of

flutolanil . For risk assessment purposes, freshwater fish serve as surrogates for aquatic

- phase amphibians. While the carp was the most sensitive freshwater fish species tested and is therefore

used in risk estimation, there were three other species tested, the rainbow trout, bluegill sunfish, and fathead minnow. These studies yielded LC 50 

### values that were 5.4, >5.4, and 4.8 mg a.i/L, respectively. The values approach the solubility limit of flutolanil of 6.53 mg/L. It’s also worth noting that were no EECs derived from any PRZM/EXAMS scenario that exceeded the solubility

limit of flutolanil.

Chronic RQs for freshwater fish exceeded the LOC for at least one scenario for 2 of 10 flutolanil uses (20%) (r ice and nursery stock uses). The NOAEC for the chronic freshwater fish was based on significant reductions in length. There were no behavioral effects noted during the study and total mortality was observed in the highest concentration (1.9 mg a.i/L) by the end of the study.

Ch ronic RQs ranged from <0.01

– 20.59. The highest RQs resulted from the soil drench nursery stock scenario, with the ground spray nursery stock resulting in RQs roughly half of the soil- Page 112 of 196

- 

### drench application method. The chronic exceed ances for rice was slightly marginal, ranging

from 1.59

– 1.96 , depending on the scenario modeled

.

The pro bability of a chance of an individual effect is estimated using the probit

- dose response (9.3 for freshwater fish) and the median lethal concentratio n. For uses that exceeded an acute LOC, the model is run using the RQ of a specific use as the threshold. The results of this analysis, expressed as a probability are tabulated below ( Table 4.21 ) for the applicable uses.

The results indicate that for th e lower RQs associated with mainly the food uses of flutolanil that

the chances of individual effect of mortality are substantially less than some of those associated with nursery stock uses, where some scenarios indicate a 1 in 1 chance of effect.

Table 4

. 2 1. Probabilities for an Individual Chance of an Effect for Uses that Exceed an

Acute LOC for Freshwater Fish

Use(s) Scenario App. Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Fish

EC 50 = 2500

μg a.i/L Probability of

chance of

individual effect (1 in...) 2 Acute RQ

Peanut NC peanut Aerial 129 0.05 1.88 X 10 33

Golf courses

, sod farms, spot fields,

residential

, institutional, municipal

& commercial areas FL turf Ground 170 0.07 3.05 X 10 26

Golf courses

, sod farms, spot fields,

residential

, institutional, municipal

& commercial areas PA turf Ground 217 0.09 8.52 X 10 21

Ornamental lawns and turf; recreation area lawns; residential

lawns; Commercial/ Industrial

lawns FL turf Ground 178 0.07 3.05 X 10 26

Nursery stock, ornamentals & fruits (unspecified) FL n ursery Ground 2300 0.92 2.72

Nursery stock, ornamentals & fruits (unspecified) NJ nursery Ground 2170 0.87 3.49

Nursery stock, ornamentals & fruits (unspecified) FL nursery Soil drench 4690 1.88 1

Nursery stock, ornamentals & fruits (unspecified) NJ nur sery Soil drench 3700 1.48 1.1

Rice 3 AR rice Aerial 1120 0.45 1588

Rice 4 AR rice Aerial 829 0.33 2.65 X 10 5

Rice 3 CA rice Aerial 1161 0.46 1169

Rice 4 CA rice Aerial 870 0.35 8.95 X 10 4

Rice LA rice Aerial 1100 0.44 2189

Rice MS rice Aerial 1100 0.44 2189

Rice TX rice Aerial 1130 0.45 1588

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5- Page 113 of 196

- 2 Slope was available from most sensitive acut e freshwater fish toxicity study which was 9.3

3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### 4.2.1.2. Freshwater Invertebrates

Freshwater invertebrates were shown in toxicity studies to be less sensitive to flutolanil than

freshwa ter fish and the acute RQs reflect this ranging from < 0.01

– 0.69

. The exceedances occurred for the same 2 uses as for freshwater fish, th at is, nursery stock and rice. Additionally, there were no ecological incidents reported to freshwater invertebrate s resulting from the use of

flutolanil

It is important to note that the acute exceedances were marginal, ranging from 0.12

– 0.69 . Also worth noting is the fact that these RQs were estimated from non

- definitive endpoints, specifically “>” toxicity endpoi nts, and therefore the RQs represent upper bound “<” values. These RQs therefore represent an “at worst,” case of risk, as the true level of risk is below the estimated value but by how much is an uncertainty. The toxicity endpoint from which acute RQs t o freshwater invertebrates is derived is > 6.8 mg a.i/L, which is slightly above the solubility limit of

flutolanil of 6.53 mg/L. However, there was 45% mortality observed at the highest treatment concentration in the acute freshwater invertebrate study, wh ich was at the limit of solubility.

EFED cannot discount these effects and so non

- definitive RQs estimated to be above the level of

the LOC are stated to have the potential to exceed.

There were 2 of 10 (20%) uses of flutolanil where chronic RQs exceeded the LOC for freshwater

invertebrates. These 2 uses (rice and nursery stock) were the same uses that resulted in acute

exceedances of the LOC for freshwater invertebrates as well as for acute and chronic LOC

exceedances for freshwater fish. Chronic RQs f rom the multiple nursery stock and rice scenarios ranged from 1.07

– 8.70

.

Refer to the section above, Section 4.2.1.1, regarding degradate toxicity to freshwater

invertebrates.

The probability of a chance of an individual effect is estimated using the p robit

- dose response (4.5 as a default for freshwater invertebrates as there was no definitive EC 50 

### reached) and the median lethal concentration. For uses that exceeded an acute LOC, the model is run using the RQ of a specific use as the threshold. The re sults of this analysis, expressed as a probability are tabulated below ( Table 4.22 ) for the applicable uses.

The results indicate that for the lower RQs associated with rice uses flutolanil that the chances of

individual effect of mortality are substant ially less than some of those associated with nursery stock uses. There is a higher level of uncertainty in these probabilities than for the freshwater

fish since the freshwater invertebrate LOC exceedances were potential and a default slope of 4.5

was us ed.- Page 114 of 196

- 

### Table 4. 22

. Probabilities for an Individual Chance of an Effect for Uses that Exceed an

Acute LOC for Freshwater Invertebrates

Use(s) Scenario App.

Method Peak

EECs

(μg

a

. i

. /L) Freshwater

Invertebrates

EC 50 = >6800 μg

a.i/L Probability of chance of

i ndividual effect (1 in...) 2

Acute RQ

Nursery stock,

ornamentals & fruits (unspecified) FL

nursery Ground 2300 <0.34 57.1

Nursery stock,

ornamentals & fruits (unspecified) NJ

nursery Ground 2170 <0.32 77.0

Nursery stock,

ornamentals & fruits (unsp ecified) FL

nursery Soil

drench 4690 <0.69 4.27

Nursery stock,

ornamentals & fruits (unspecified) NJ

nursery Soil

drench 3700 <0.54 8.75

Rice 3 AR rice Aerial 1120 <0.16 5853

Rice 4 AR rice Aerial 829 <0.12 5.85 X 10 4

Rice 3 CA rice Aerial 1161 <0.17 3744

Rice 4 CA rice Aerial 870 <0.13 2.99 X 10 4

Rice LA rice Aerial 1100 <0.16 5853

Rice MS rice Aerial 1100 <0.16 5853

Rice TX rice Aerial 1130 <0.17 3744

App. = Application

Bolded and shaded values indicate an exceedance of an LOC, italicized values repr esent a potential to exceed an

LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5

2 Slope was not available from most sensitive acute freshwater invertebrate toxicity study and therefore default slope

of 4.5 was employed for probably of acute effect estimates



### . 3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### 4.2.1.3. Estuarine/Marine Fish

Estuarine/marine fish were shown to be less sensitive in available toxicity studies than

freshwater fish. In the available acute toxicity study, fish were exposed to treatment concentrations approaching the limit of solubility for flutolanil (6.53 mg/L). There were no mortalities observed in the study at all treatment concentrations. As there were no EECs that exceeded 4.7 mg a.i/L for any use of flutolanil, acute risk to estuarine/marine fish is presumed to

be below the LOC.

As discussed previously in the assessment, there is too great a level of uncertainty with using an

acute

- to

- chronic ratio (ACR) that is estimated from non

- definitive endpoints, as was the case with acute toxicity to estuarine/marine fish. In that study flutolanil was exposed to fish up to- Page 115 of 196

- 

### levels nearing the limit of solubility and there was no mortality observed at any concentrat ion. There were observations however, of behavioral effects at the top two concentrations that included lethargy, loss of equilibrium, surfacing, and fish observed to be on the bottom of the tank. It is unclear how these sublethal effects would impact fi sh in a chronic exposure study and so while chronic RQs to estuarine/marine fish are not being estimated, chronic risk cannot be

ruled for estuarine/marine fish.

The probability of an individual chance of effect was estimated using the default slope of 4. 5 as there was not one that could be derived from the available study. This resulted in a probability

chance of 1 in 4.8 X 10 8 

### , however as indicated above, there were no mortalities in the available acute toxicity study that exposed fish up near the limit of solubility

. 

### Furthermore, there were no reported wildlife incidents with flutolanil involving estuarine/marine fish.

4.2.1.4. Estuarine/Marine Invertebrates

Estuarine/marine invertebrates were shown to be at least one order of magnitude more toxic than freshwater invertebrates on an acute and chronic basis. As a result, there were more flutolanil

uses in which acute and chronic risk above the level of the LOC was indicated. Specifically, 8 of 10 (80%) of flutolanil uses (at least one modeled scena rio) exceeded at least one acute risk LOC and the chronic LOC. Acute RQs ranged from <0.01

– 36.1 and chronic RQs ranged from 0.01

– 408. The NOAEC for this study was based on significant reductions in survival, number of young produced per female, and d ry weight at the top three treatment concentrations in the studies, ranging from 22

– 97 μg a.i/L. Several scenarios yielded 21

- day EECs that greatly exceeded this range that include a few food uses and all turf and nursery stock use s. Additionally the re were no reported wildlife incidents reported for flutolanil involving

estuarine/marine invertebrates

.

For the uses on rice, a cute and chronic RQs exceeded the LOCs for all the scenarios evaluated. The acute RQs ranged from 6.38 to 42.2 (13 to 84 times above the acute non

- listed LOC) and the chronic RQs ranged from 46.2 to 57.4 (46 to 57 times above the chronic LOC). H owever, for the

rice use

, for which EEC results returned among the highest EECs out of a ll registered and proposed uses, label language prohibits the use of flutolanil application within 3 miles of any estuarine/marine waterway s or watershed. As a consequence of this restriction, the EECs calculated using PFAM, may have been overestimated , and all RQs that exceeded the LOCs for

the use on rice may also be overestimated (refer to Section 4.2.1.7 for further characterization)

. This is relevant in all instances where the LOCs are exceeded for the use on rice

. Given that for

estuarine/marine invertebrates the RQs exceeded LOCs by factors of up to 57X, there is a

likel i hood that in some instances, despite label restrictions, EECs in real world environments would by high enough to cause exceedances of LOCs.

The probability of a chance of an individual effect is estimated using the probit

- dose response (4.5 as a default for estuarine/marine invertebrates as there was no definitive LC 50 

### reached) and the median lethal concentration. For uses that exceeded an acute LOC, the model is run using the RQ of a specific use as the threshold. The results of this analysis, expressed as a probability are tabulated below ( Table 4.23 ) for the applicable uses.- Page 116 of 196

- 

### The results indicate that for the lower RQs generally associated the food uses of flutolanil (except rice) that the chances of individual effect of mo rtality are substantially less than some of those associated with nursery stock uses , turf, and rice uses where the probability is 1 in 1

.

Table 4. 23

. Probabilities for an Indiv idua l Chance of an Effect for Uses that Exceed an

Acute LOC for Estuari n e/m arine Invertebrates

Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 130 μg a.i/L Probability of

chance of individual effect (1 in...) 2

Acute RQ

Peanut NC

peanut In

- furrow at plant 30.1 0.23 491

Peanut NC

peanu t Ground banded apps 41.8 0.32 77.0

Peanut NC

peanut Aerial 129 0.99 2.03

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens CA cole

crops Ground in a

narrow band 36.7 0.28 156

Brassica (cole) Leafy Vegetables (Crop Group 5) plus Turnip Greens FL cabbage Ground in a

narrow band 71.4 0.55 8.24

Potatoes ID Potato In furrow band app 8.27 0.06 5.22 X 10 7

Potatoes ME

Potato In furrow band app 30.1 0.23 491

Potatoes ME

Potato Seed piece

treatment 12.5 0.10 2.94 X 10 5

Soybeans MS soybean See d

treatment 20 0.15 9558

Golf courses

, sod farms, spot fields, residential

, institutional, municipal &

commercial areas FL turf Ground 170 1.31 1.43

Golf courses

, sod farms, spot fields, residential

, institutional, municipal &

commercial areas PA turf Gr ound 217 1.67 1.19

Ornamental lawns and turf; recreation area lawns;

residential lawns;

Commercial/ Industrial lawns FL turf Ground 178 1.37 1.37

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Ground 2300 17. 7 1

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Ground 2170 16. 7 1

Nursery stock, ornamentals &

fruits (unspecified) FL

nursery Soil drench 4690 36. 1 1

Nursery stock, ornamentals &

fruits (unspecified) NJ

nursery Soil drench 3700 28. 5 1- Page 117 of 196

- Use(s) Scenario App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 130 μg a.i/L Probability of

chance of individual effect (1 in...) 2

Acute RQ

Rice 3 AR rice Aerial 1120 8.62 1

Rice 4 AR rice Aerial 829 6.38 1

Rice 3 CA rice Aerial 1161 8.93 1

Rice 4 CA rice Aerial 870 6.69 1

Rice LA rice Aerial 1100 8.46 1

Rice MS rice Aerial 1100 8.46 1

Rice TX rice Aerial 1130 8.69 1

App. = Application

Bolded and shaded values indicate an exceedance of an LOC

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute hig h risk LOC = 0.5

2 Slope was not available from most sensitive acute estuarine/marine invertebrate toxicity study and therefore default slope of 4.5 was emplo yed for probably of acute effect estimates.

3 1 application of 0.980 lbs a.i/A

4 2 applications of 0.490 lbs a.i/A



### 4.2.1. 5

. Sediment

- dwelling Organisms

Flutolanil is shown to have a moderately high octanol/water partition coefficient (log K OW 

### = 3.79) and a tendency to partition with soils with moderately high K OC 

### s. When taken with the

fact that half lives are long in the aquatic media, the chemical is relatively persistent in both

aerobic and anaerobic soils , and the propensity to bind to soils, sediment exposure cannot be discounted. Batch equilibrium studies show parent flutolanil to be moderately mobile ( mean
K OC 

### = 780.7 mL/g OC 

### )

.

As mentioned previously, acute and chronic to sediment

- dwelling organisms is estimated i n a variety of ways. There are a few reasons for this that will be discussed briefly. First, multiple routes of exposure are taken into account. Sediment

- dwelling organisms are simultaneously respiring pore and overlying water, ingesting potentially chemical contaminated sediment, and potentially receiving the chemical through dermal uptake. Additionally, differing factors affecting bioavailability are accounted for. Different compartments have differing levels of organic carbon quality, to which the chemical may sorb to, as well taki ng into account the influence of other sorption matrices, and the fact that non

- equilibrium conditions may be present. Finally, there is shown to be a broad range of sensitivity among invertebrate taxa, and therefore a risk estimation paradigm that estima tes RQs in several ways, using sediment and water column

invertebrate data accounts for this.

This discussion is illustrated in the freshwater and estuarine/marine sediment

- dwelling organism acute and chronic RQs for flutolanil. Acute risk quotients ar e based on the peak pore water EEC

and the most sensitive water column EC 50 

### . Chronic RQs are derived either by: m odeled 21

- day

por e water EECs are compared to the measured pore water NOAEC from available sediment- Page 118 of 196

- 

### studies; modeled 21

- day sediment EECs are compared to the measured sediment NOAEC; and

modeled 21

- day pore water EECs are compared to the most sensitive surface water NOAEC.

Acute risk quotients for freshwater benthic invertebrates ranged from <0.01

– <0.63

. There is some uncertainty in these RQ s however, since they were estimated using a non

- definitive endpoint (“>”) and therefore the resultant RQs are preceded with a “<” that represent an upper bound “worst case,” scenario of risk. Exactly how far below that determined non

- definitive RQ

is an uncertainty. The nursery stock uses are stated to have the potential to exceed the acute LOC for freshwater sediment dwelling invertebrates as the limit of solubility was determined to have a 45% mortality effect on water column freshwater invertebrates fr om which these RQs are

derived.

Chronic RQs for freshwater benthic invertebrates based off of toxicity values expressed in terms

of sediment concentration s (EECs and toxicity endpoints) ranged from < 0.1

– 0.01 and therefore there were no registered or pro posed uses of flutolanil that exceeded the LOC when concentrations were expressed in terms of sediment concentrations. When expressed in terms of pore water EECs and endpoints from sediment toxicity studies expressed in terms of pore water,

there no uses o f flutolanil that exceeded the LOC (RQs ranged from <0.01

– 0.05). Finally

, chronic RQs based on pore water EECs compared to surface water endpoints resulted in RQs that exceeded the LOC for one use of flutolanil (nursery stock), RQs r anged from 0.01

– 8.08

. As was the case with water column invertebrate data, estuarine/marine sediment toxicity endpoints are more sensitive than available freshwater sediment toxicity data. As a result, a cute risk quotients for estuarine/marine benthic invertebrates r anged from <0.01

– 32.92 . There were 8 of 10 (80%) of flutolanil uses that exceeded at least one acute LOC for at least one modeled

scenario.

Chronic RQs for estuarine/marine sediment

- dwelling invertebrates based off of toxicity values expressed in terms of sediment concentrations (EECs and toxicity endpoints) ranged from <0.1

– 6.51. Only the nursery stock use exceeded the chronic LOC. When RQs were estimated using pore water EECs and endpoints from sediment toxicity studies expressed in terms of pore water, there no uses of flutolanil that exceeded the LOC (RQs ranged from <0.01

– 0.61). Finally

, chronic RQs based on pore water EECs compared to surface water endpoints resulted in RQs that ranged from 0.01

– 379. There were 8 of 10 (80%) of flutola nil uses that exceeded at least

one acute LOC for at least one modeled scenario.

In both available sediment toxicity studies, radio

- labeling was performed to track the chemical throughout the course of the study. The endpoints were subsequently provided in terms of mg

TRR /kg sediment or mg TRR/L (TRR = total radioactive residues). The RQs were estimated using the assumption that1 mg TRR/kg sediment and 1 mg TRR/L is equal to 1 mg a.i/L sediment and 1 mg a.i/L, respectively . While this approach may seem under conservative as if the chemical undergoes degradation, then the actual a.i will be a lower concentration than the TRR, flutolanil is shown to be stable in both aerobic and anaerobic aquatic conditions. Aerobic aquatic metabolism half life value was determined to be 1095 days while anaerobic conditions

were assumed to be stable (half life > 13 years). Sediment toxicity studies are substantially less- Page 119 of 196

- 

### time in durat ion and therefore the aforementioned assumption is considered to be appropriate for

estim ating risk to freshwater and estuarine/marine sediment dwelling invertebrates.

4.2.1. 6

. Aquatic Plants

The results of this screening level risk assessment indicate that certain uses has the potential to pose risk to nonlisted aquatic vascular plants. Risk quotients for listed aquatic nonvascular plants were not estimated since there are currently no listed aquatic non

- vascular species. For nonlisted aquatic nonvascular plants, there were 2 of 10 uses that exceeded the LOC (RQs ranged from <0.01

- <5.8 6 ) . There is some uncertainty however, in the nonlisted species RQs for aquatic nonvascular plants as these RQs were determined using a non

- definitive EC 50 

### value (“>”) and therefore the RQs represent an upper bound, “worst case,” scenario of risk. Simila rly,

non

- listed species RQs for aquatic vascular plants were determined using a non

- definitive EC 50 

### (“>”) and therefore represent an upper bound “worst case,” scenario of risk. Consequently, the resultant RQs are preceded by a “<” value to indicate what l evel of risk would be yielded at most (RQs range from <0.01

– <0.59) . There were no exceedances for listed species for aquatic vascular plants. There is uncertainty with these RQs as well as they were determined using a

non

- definitive NOAEC (“<”) in whi ch the resultant RQs represent a lower bound, “best case,” scenario of risk. Resultant RQs therefore are preceded with a “>” sign in which the values

denote a level of risk that at least be indicated. There are currently no listed species of aquatic

non vascular plants and therefore no RQs were estimated.

4.2.1. 7

. Refinement of Estuarine/Marine Organism Risk

Rice Use

L abels have restrictions for applications near marine/estuarine areas for uses on rice . For example, for Convoy ® 

### Fungicide, for the us e on rice, the following statement is shown in the supplemental label: “This pesticide is toxic to shrimp. Do not apply this product within three miles of any estuarine/marine waterways or watershed.” Currently EFED does not have a tool to

estimate the l evel of reduction that such a restriction would mean, since PFAM cannot account for this type of buffer zone. The actual EECs to which an estuarine/marine body of water would be exposed (and hence the RQs), may have been overestimated. P rocesses that are expected to occur in transit to the estuarine/marine bodies of water are likely dilution and aerobic aquatic metabolism (half

- life is 1 year). Flutolanil does not degrade readily under most testing

conditions , but field studies did not show very high per sistence overall

. Although residence

times are not high, some aquatic metabolism will occur; further , dilution may take a major role in the ‘dissipation’ of flutolanil in such circumstances. Additionally, it is possible that the chemical

will bind to sed iments and particulate found in the course of a 3

- mile travel to encounter an estuarine/ marine body of water. Thus, i t is likely that the EECs found in those bodies of water are lower than the estimated ones; nonetheless, the levels of reduction are high ly uncertain.- Page 120 of 196

- 

### Turf Use

For the uses on turf the following sample label statements appear in the label of ProStar 70WP Fungicide, “For use rates over 2.2 oz per 1,000 sq. ft. do not apply ProStar 70WP Fungicide within 100 ft. of any estuary or marine habitat or within 100 ft. of any ditches, drainage tiles, or
other waterways that drain directly into (within 

## 1⁄2 mile of estuaries or marine habitats.” Another example, in the label for Flutolanil SC (also named Convoy ® 

### 40SC) , “ For use rates greater than

4 .4 fl oz per 1,000 square feet, do not apply Flutolanil 40SC within 100 feet of any freshwater or marine estuary, ditches, drainage tiles, or other waterway that drains directly (within 1⁄2 mile) into

estuaries.”

As a refinement, the spray drift value for a buffer zone of 100 ft towards freshwater bodies of water for ground applications was determined. Using a low boom height (which is the one likely for applications on turf , but high boom is not precluded ), a droplet size of ASAE Very Fine to Fine (default used by EFED), and the 90 th 

### percentile value, the spray drift value in AgDRIFT

v.2.1.1 is 0.5 % (or 0.005 if expressed as a fraction) . This is compared against the default spray drift of 1% for ground applications. The estimated environmental exposure co ncentrations (EECs) are presented in Table 4. 2 4 . As expected, the EECs decreased when the value of spray drift was decreased. For the Florida turf scenario, the peak EEC in the water column decreased by 15%, while for the Pennsylvania turf scenario, the peak EEC decreased by 16%. EPA also expects that EECs would decrease due to reduction of runoff and sediment transport over the

100

- foot buffer. However, the extent of such reductions are highly variable, depending on the quality and type of vegetation in the 100

- foot zone and whether channelized flow corridors that might bypass the buffers exist, and cannot be quantified.- Page 121 of 196

- 

### Table 4. 2 4

. Surface Water Estimated Environmental Concentrations (EECs) for the Golf Course and Other Turf Uses of

Flu tolanil, Assumin g Various Buffer Zones 1

Scenario (bold font)/ Crops/Uses Represented App

. Method 2

(% drift) App

Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps

. App

. Interval

(days) Water Column Pore Water Sediment 3

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L) Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) Peak

EEC (μg/ kg

oc ) 21

- day

average

EEC (μg/ kg

oc )

14a FL turf/ Golf

courses
, sod farms, spot fields,

residential

, institutional, municipal &

commercial areas Ground (1.0%) 8.6 15

- 03 2 14 170 168 162 157 157 124000 124000

15a PA turf /

Same as above Ground (1.0%) 8.6 15

- 03 2 14 217 214 210 204 204 161000 161000

14b FL turf/

Same as above Ground (0.5%) 8.6 15

- 03 2 14 145 143 139 134 134 106,000 106,000

15b PA turf /

Same as above G round (0.5%) 8.6 15

- 03 2 14 183 181 177 171 171 135,000 135,000

1

. EECs were rounded to three significant figures.

2

. 1.0% drift represents the scenario with no buffer zone; 0.5% is the scenario with a 100 ft buffer zone. All results are pres ented for co mparison purposes.

3

. Sediment EECs are organic carbon normalized values.- Page 122 of 196

- 

### Refinement of risk was not conducted for estuarine/marine fish as previous sections have

indicated that acute risk to estuarine /marine fish would be presumed to be below the level of

concern and chronic risk could not be estimated based on lack of data and suitable means to estimate toxicity.

When compared to the available acute and chronic toxicity data for estuarine/marine invertebrates, the refined scenarios of exposure resulte d in RQs that were very similar to those that were estimated without the use of a buffer zone ( Table 4. 2 5 ). Acute RQs for the ground turf

use exceeded all acute endangered species, acute restricted, and acute LOC s for the turf uses (RQs ranged from 1.12

– 1.67 for both the FL and PA turf scenarios ). Similarly, t here were

chronic LOC exceedances for the turf use (both scenarios) and all buffer scenarios (0, 100 and 2,640 ft) exceeded the chronic LOC of 1 (RQs ranged from 0.15

– 18.9 for both the FL and PA

turf scenarios ).

Table 4. 2 5 . Acute RQs for Direct Effects to Estuarine/Marine Invertebrates from

Flutolanil TGAI. 1,2

Use(s) Scenario (% drift) App.

Method Peak

EECs

(μg ai/L) Estuarine/marine

Invertebrates

EC 50 = 130 μg

a.i/L 21

- day

EECs

(μg ai/L) Estuar ine/marine

Invertebrates

NOAEC = 11.3 μg

a.i/L

Acute RQ Chronic RQ

Golf courses

, sod farms, spot fields, residential

, institutional, municipal &

commercial areas FL turf (1%) Ground 170 1.31 168 14. 9

Golf courses

, sod farms, spot fields, residentia l

, institutional, municipal &

commercial areas PA turf (1%) Ground 217 1.67 214 18.9

Golf courses

, sod farms, spot fields,

residential

, institutional, municipal & commercial

areas FL turf (0.5%) Ground 145 1.12 139 12.3

Golf courses

, sod farms, spot

field s, residential

, institutional, municipal &

commercial areas PA turf (0.5%) Ground 183 1.41 177 15.7

App. = Application

1 Bolded and shaded values indicate an exceedance of an LOC

2 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1

3 Slope was not available from most sensitive acute estuarine/marine invertebrate toxicity study and therefore default slope of 4.5 was employed for probably of acute effect estimates.



### When compared to the available acu te and chronic toxicity data fo r estuarine/marine species living in the benthos , the refined scenarios of exposure resulted in RQs that also were very similar to those that were estimated without the use of a buffer zone ( Table 4. 2 6 ). Acute RQs for the gr ound turf use exceeded all acute endangered species, acute restricted, and acute LOC s for turf uses (RQs ranged from 1.03

– 1.5 7 ) for both the FL and PA turf scenarios ). Similarly,- Page 123 of 196

- 

### t here were chronic LOC exceedances for the turf use (both scenarios) and a ll buffer scenarios (0 and 100 ft) exceeded the chronic LOC of 1 when the EECs were compared against endpoints generated using a water column study (RQs ranged from 11.9

– 18.05 for both the FL and PA

turf scenarios ).

Table 4. 2 6 . Acute RQ and Chronic RQs for Direct Effects to Estuarine/Marine Sediment

Dwelling Invertebrates from Flutolanil TGAI. 6

Use(s) Scenario App.

Method Acute Chronic

Peak

Pore

Water

EECs

(μg ai/L) Acute RQ 2 21

- day

sediment

EECs (mg / Kg OC ) 21

- day

pore
water
EECs

(μg ai/L) Chronic RQ (sediment) 3 Chronic RQ (pore water) 4 Chronic RQ (pore

water /

surface water) 5

Golf courses

,

sod farms, spot fields,

residential

, institutional, municipal &

commercial

areas FL turf (1%) Ground 157 1.21 124000 157 0.24 0.02 13.9

Golf courses

,

sod farms, spot fields,

residential

, institutional, municipal &

commercial

areas PA turf (1%) Ground 204 1.57 161000 204 0.31 0.03 18.1

Golf courses

,

sod farms, spot fields,

residential

, institutional, municipal &

commercial

areas FL turf (0.5%) Ground 134 1.03 106 ,000 134 0.20 0.02 11.9

Golf courses

,

sod farms, spot fields,

residential

, institutional, municipal &

commercial

areas PA turf (0.5%) Ground 171 1.32 135,000 171 0.26 0.02 15.1

1 Bolded and shaded values indicate an exceedance of an LOC.

2 Based on peak po re water EEC divided by 130 ug a.i/L (EC 50 value of most sensitive estuarine/marine water column invertebrate)

3 Based on 21

- day organic carbon (OC)

- normalized sediment EECs divided by OC

- normalized NOAEC of Leptocheirus plumulosus (MRID 48802201) of 519000 μg a.i/kg sediment.- Page 124 of 196

- 4 Based on 21

- day pore water EECs divided by pore water NOAEC of Leptocheirus plumulosus (MRID 48802201) of 7000 μg a.i/L.

5 Based on 21

- day pore water EECs divided by 11.3 μg a.i/L (NOAEC value of most sensitive estuarine/marine

water c olumn invertebrate )

6 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### 4.2.1. 8

. Evaluating PR ZM/EXAMS Results and Accumulation

Evaluation of the results of the modeling shows an increasing trend of the EECs in PRZM/

EXAMS. For example, the following is a portion of the output file for the NC peanut aerial application EECs ( in the surface waters ) . The table shows the maximum values for each year. From the output file, it is evident that fl utolanil was increasing throughout the run at least through around 198 4

.

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 9.373 9.192 8.645 7.767 7.322 3.256

1962 19.84 19.52 19 17.56 17.03 11.62

1963 29.48 29.17 28.08 26.5 24.28 19.18

1964 37.22 37.01 36 .45 35.88 35.41 28.85

1965 40.17 39.97 39.23 38.33 38.05 35.34

1966 48.79 48.45 47.28 46.29 45.92 40.55

1967 51.12 50.89 50.16 49.12 48.71 45.66

1968 59.05 58.7 57.35 56.2 55.73 51.16

1969 66.96 66.59 65.58 64.26 63.7 58.29

1970 76.01 75.51 74.71 73.49 72. 51 65.55

1971 76.33 76.02 74.89 74.37 74.24 70.9

1972 87.96 87.6 86.08 84.42 83.8 76.86

1973 87.53 87.24 86.68 85.66 85.08 81.79

1974 92.51 92.14 90.82 89.89 89.28 85.27

1975 107 106 104 100 98.71 91.24

1976 102 102 101 100 99.68 95.15

1977 108 108 106 105 104 99.61

1978 112 111 110 107 106 103

1979 115 114 113 112 112 107

1980 111 111 110 110 109 109

1981 115 115 114 114 113 110

1982 114 114 113 112 112 111

1983 112 112 112 111 110 109

1984 129 128 126 123 121 114

1985 123 123 122 121 120 117

1986 129 128 127 124 123 119

1987 129 128 127 126 125 121

1988 125 125 124 124 123 121

1989 127 127 125 124 124 121

1990 122 122 121 121 121 119



### There are a number of reasons why the estimated environmental exposure concentrations (EECs) may have been conservative and possibly they are overestimates. These include: a) that the PRZM/EXAMS input parameters may have been overly conservative, b) that field dissipation studies point towards lower persistence than noted from the results of PRZM/EXAMS, c) since

the chemical shows m edium to high pest resistance (as indicated by F ungicide Resistance Action

Committee for chemicals in Group 7), it may not be applied as often as modeled in PRZM/EXAMS, and d) that the standard pond used in PRZM/EXAMS does not include flow or

turnov er, which may remove part of the flutolanil received in the pond.- Page 125 of 196

- 

### Even though the aerobic soil metabolism half

- life used in modeling in PRZM/EXAMS shows moderate persistence (input value 308 days), in the aquatic environment the input half

- lives were

indic ative of high persistence as follows : stable to hydrolysis , stable to aqueous photolysis , 1095 days for aerobic aquatic metabolism (3X the available value)

, and stable to anaerobic aquatic

metabolism . These input values were derived from laboratory studie s . The aerobic aquatic metabolism study yielded a half

- life of 1 year

. Additionally, the anaerobic aquatic metabolism study yielded a half

- life of 13 years (assumed to be stable in modeling). In the absence of additional metabolism studies, th ese half

- l i ves are multiplied by 3 as per current Input Parameter Guidance v.2.1, dated 10/22/2009 and approved 11/10/2009 (USEPA 2009b). These assumptions are conservative and may have caused the increasing trend in the aquatic

environment in PRZM/EXAMS. Despite being conservative, they are used in the absence of additional soils and sediments (per the guidance).

There are five terrestrial field dissipation studies conducted in CA and FL, one of which is a long term study conducted for a period of three years. T hese studies included both cropped (turf, peanuts), and bareground plots. Half

- lives derived from the field studies ranged from 27 to 225 days (the latter value of 225 days being a secondary half

- life) . Three half

- lives derived from the long term study were 118, 126 and 123 days, respectively, for the first, second and third years (note the consistency of these half

- lives throughout a three

- year period ) . These results suggest

little or no buildup of material with time in the terrestrial field. Addition ally, there is an aquatic field dissipation study, conducted in two sites: CA and LA ; that yielded half

- lives of 303 and 63 days, respectively . Again, these half

- lives do not suggest substantial buildup of flutolanil with time in the aquatic environment.

Additionally, this chemical belongs to the p henyl benzamide class , which shows m edium to high risk ( meaning resistance management is required) according to FRAC

. According to the Crop and Pest Management Guidelines ( http://ipmguidelines.org/Turfgrass/Chapters/CH05/default

4.aspx , accessed 01/31/14 , in this instance for turf uses

, although they may appl y to other crops in general), some of the possible management practices used to avoid resistance include the following (see also Fungicide Resistance Management from Oklahoma Cooperative Extension

Services at http://pods.dasnr.okstate.edu/ docushare/dsweb/Get/Document

- 2317/F

- 7663web.pdf

, accessed 01/31/14) :

• Use appropriate cultural practices ( e.g. , crop rotations, use resistant varieties of plants,

maintain appropriate soil fertility).

• Limit the number of fungicide applications and in gener al u se a fungicide no more than two times before rotating to another fungicide with a different mode of action and another

FRAC code ;

• Avoid applications at lower rates than specified in the labels ; apply at appropriate rate, intervals, and crop stages, acc ording to the labels specifications ;

• Apply making sure the crop is fully covered; and,

• When possible, avoid preventative applications if the risk of disease is low; chemicals of this class are not intended for well established pests

.

It appears that the c hemical would not be used on the field for several consecutive years, or that

there would not be many consecutive applications in a given year (for the above example, on- Page 126 of 196

- 

### peanuts, a single application was modeled)

. Some l abels for other fungicides direct t he user to apply up to twice a chemical and rotate the applications with another pesticide with a different

mode of action. Flutolanil labels do not have such restriction. Nonetheless, EFED’s Preliminary

Risk Assessments are based on the maximum use rate s and minimum intervals between applications and EECs are based on maximum use scenarios

. The standard PRZM/EXAMS scenario consists of application to a 10

- hectare field bordering a 1

- hectare, 2

- meter deep (20,000 m 3 

### ) pond with no outlet . Exposure estimate s generated using the EXAMS pond is intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man

- made and natural ponds, and intermittent and lower order streams. As a group, there are factors that make these water bodies more or less vulnerable than the EXAMS pond. Static water bodies that have larger ratios of pesticide

- treated drainage area to water body volume would be expected to have higher p eak EECs than the EXAMS pond. These water bodies will be either smaller in size or have larger drainage areas. Smaller water bodies have limited storage capacity and thus may overflow and carry pesticide in the discharge, whereas the EXAMS pond has no di scharge

.

The standard pond does not have flow or water turnover which would have caused a portion of the chemical to be discharged away from the pond . This may cause that, for moderately to highly persistent chemicals, they would build up with time and t he model would overestimate EECs, when compared to real life concentrations in the environment for a similarly sized pond that does have an outlet. Comparisons of terrestrial and aquatic field dissipation half

- lives with the input values used in PRZM/EXAM S shows that in the field, flutolanil did not persist as much as anticipated by the model.

While these facts appear to point towards lower persistence for flutolanil than used in the modeling, there is uncertainty as to what degree there is persistence or no persistence. For comparison purposes, the same NC peanut scenario (aerial applications), was performed , but using an aerobic aquatic metabolism half

- life of 365 days (instead of 1095 days) and an anaerobic aquatic metabolism half

- life of 4745 days (13 years , instead of stable ) , in a theoretical

PRZM/EXAMS run . The yearly maximum values were as shown below . It is noted that there was no buildup of flutolanil with time (some increase was observed from approximately 1961 to 1970).

Year Peak 96 hr 21 D ay 60 Day 90 Day Yearly

1961 9.114 8.919 8.355 7.393 6.917 3.083

1962 18.82 18.43 17.87 16.19 15.54 10.47

1963 25.69 25.37 24.24 22.61 20.44 16.26

1964 30.82 30.51 29.86 29.32 28.85 23.49

1965 31.23 30.98 30.13 29.36 28.85 26.85

1966 36.48 36.09 34.76 33.5 6 33.06 28.84

1967 35.2 34.93 34.09 32.95 32.51 30.6

1968 40.83 40.42 38.85 36.97 36.22 32.82

1969 44.57 44.15 43.05 41.4 40.67 36.44

1970 50.7 50.13 49.07 47.35 46.06 40.06

1971 46.93 46.56 45.22 44.33 43.93 41.45

1972 54.28 53.86 52.1 50.41 49.5 43.51

19 73 49.74 49.4 48.7 47.6 46.89 44.5

1974 50.95 50.53 49.03 47.79 47.04 44.2

1975 62.35 61.58 58.98 54.83 53.14 46.61

1976 52.89 52.51 51.22 50.36 49.9 46.79- Page 127 of 196

- 1977 55.22 54.79 53.3 51.67 51.12 47.89

1978 56.48 55.99 54.2 51.65 50.5 48.11

1979 55.61 55.24 54.1 2 52.84 52.84 48.65

1980 50 49.88 49.78 49.55 49.35 47.45

1981 50.38 50.16 49.44 48.53 48.02 45.8

1982 47.95 47.91 47.74 47.33 47.01 44.84

1983 44.3 44.01 43.17 42.72 42.51 41.28

1984 59.28 58.61 56.89 53.23 51.49 44.56

1985 51.79 51.42 49.94 48.98 47.94 4 5.42

1986 55.1 54.6 53.12 50.61 49.49 45.59

1987 53.11 52.7 51.68 50.05 49.13 45.56

1988 48.35 48.09 47.46 46.51 46.15 44.93

1989 48.89 48.55 47.33 45.98 45.67 43.61

1990 43.68 43.4 42.89 42.55 42.27 40.77



### A comparison of the surface waters 1

- in

- 10 year E ECs is provided in Table 4. 2 7 . In both instances, the EECs did not decrease substantially from the peak to the 21 day to the 60 day averages; however, for the special run, the EECs were less than one half of the EECs obtained in PRZM/EXAMS using the stand ard input values , for a reduction of over 50%

. Table 4. 2 7 also has an example run for the FL nursery scenario, soil drench. The FL nursery scenario provides an example of a run with multiple applications in a year.

Table 4. 2 7 . Surface Water Estimated E nvironmental Concentrations (EECs) for the Use of

Flutolanil on Peanuts (Aerial Application), and FL Nursery (Soil Drench Application), Using Standard Input Values and Without Using the 3X Factor in the Input Parameters 1

Scenario (bold font)/ Crops/Uses

Re presented App

. Method App.

Rate

(lb a.i./A) Date of

First Application (dd

- mm) Number

of Apps

. App

. Interval

(days) Water Column

Peak

EEC (μg/L) 21

- day

average

EEC (μg/L) 60

- day

average

EEC (μg/L)

STANDARD INPUT PARAMETER S

03 NC peanut /

Peanuts Aer ial 2.00 06

- 07 1 N/A 129 126 124

19 FL nursery / Nursery stock,

ornamentals & fruits (unspecified) Soil

drench 21.5 01

- 03 4 21 4690 4610 4530

MODIFIED INPUT PARAMETERS

03 NC peanut /

Peanuts Aerial 2.00 06

- 07 1 N/A 56.4 54.2 52.7

19 FL nursery /
Nursery s tock,

ornamentals & fruits (unspecified) Soil

drench 21.5 01

- 03 4 21 2260 2170 2110

1 EECs were rounded to three significant figures

.



### Table 4. 2 8 shows the resultant RQs for the NC peanut and FL nursery scenarios for standard vs

. modified PRZM/EXAMS input s. As stated previously, modified input parameters within PRZM/EXAMS yield acute and chronic RQs that are approximately 2.3 fold less than those derived from standard input parameters. As a result (for the two modeled scenarios) acute and

chronic risk to estuarine/marine invertebrates remains above the LOC for both uses for modified parameters but acute and chronic risk to all other assessed taxa falls below the level of concern for the modified FL nursery scenario.- Page 128 of 196

- 

### Table 4. 2 8 . Resultant Acute and Chroni c RQs for Aquatic Taxa Comparing Standard PRZM/EXAMS Inputs vs. Modified with the Peanut (Aerial Application) and Nursery (Soil Drench Application) Use s 1

Scenario (bold font)/ Crops/Uses Represented FW Fish FW Inverts E/M Fish 2 E/M Inverts

Acute Chronic Acute Chronic Acute Chronic Acute Chronic

03 NC peanut /

Peanuts (STANDARD

INPUT PARAMETERS) 0.05 0.56 0.02 0.24 0.99 11.2

19 FL nursery/ Nursery stock,

ornamentals &

fruits (unspecified) (STANDARD

INPUT PARAMETERS) 1.88 20. 6 0.69 8.70 36.1 40 8

03 NC peanut /

Peanuts (MODIFIED

INPUT PARAMETERS) 0.02 0.24 0.01 0.10 0.43 4.80

19 FL nursery/ Nursery stock,

ornamentals &

fruits (unspecified) (MODIFIED

INPUT PARAMETERS) 0.90 10.1 0.33 4.09 17.4 192

1 Bolded and shaded values indicate an exceedance of a n LOC, italicized values represent a potential to exceed an

LOC

2 Acute and chronic risk to estuarine/marine fish was not estimated as there were no mortalities in the acute study up to solubility limit and no chronic fish study is available. An acute

- to

- chronic ratio (ACR) was not utilized to estimate chronic toxicity as there is a high level of uncertainty in using an ACR with a non

- definitive acute toxicity endpoint.



### 4.2.1.9 Evaluation of the Frequency of Exposure Estimate Excursions above Levels of Concern (f ocus on Estuarine/Marine Invertebrates)

Risk quotients are commonly calculated on the basis of the 1 in 10 year return frequency values from the multiple years of modeled daily receiving water exposures. The modeling, however, is

a rich set of estimates comprising daily model predictions of concentrations for three decades of pesticide use. Additional analysis of this data set was made to compare the entire time series of exposures to the acute toxicity endpoints (modified to correspond with Agency level s of concern). This was conducted for the same scenarios that the modified input parameters were conducted for ( i.e

. , NC peanuts aerial scenario and FL nursery soil drench scenario). Focus was- Page 129 of 196

- 

### placed on effects to estuarine/marine invertebrate risks (the taxa that most uses of flutolanil had RQs for that exceeded acute and chronic LOCs) and involved comparison of daily estimates to the acute estuarine/marine toxicity endpoint adjusted for non

- listed species level of concern (LC 50 

### x 0.05) and for the listed species level of concern (LC 50 

### x 0.05). The following table ( Table 4. 2 9 ) presents the number of days that exceeded the adjusted toxicity endpoints. The

table shows that when the A gency ’s level of concern is triggered using the screening level approach, this is not expected to be an isolated incident only limited to a single exposure event. Modeling results for 30 years would suggest exposure events exceed the adjusted acute effects endpoints quite often, ranging from 0 days to more than 10800 days, depe nding on the scenario

modeled and LOC examined

.

Table 4. 2 9 : LOC Excursions for Freshwater Aquatic Invertebrates from PRZM/EXAMS Standard PRZM/EXAMS Inputs vs. Modified with the Peanut (Aerial Application) and Nursery (Soil Drench Application) Use s

Use Tot al Days Days LOC Exceeded from

PRZM/EXAM Simulation

Acute NL 1 Acute L 1

03 NC peanut / Peanuts (STANDARD INPUT PARAMETERS) 10957 7498 10693

19 FL nursery/ Nursery stock, ornamentals & fruits (unspecified) (STANDARD INPUT PARAMETERS) 10957 10855 10892

03 NC peanut / Peanuts (MODIFIED INPUT PARAMETERS) 10957 0 10471 19 FL nursery/ Nursery stock, ornamentals & fruits (unspecified) (MODIFIED INPUT PARAMETERS) 10957 10853 10892

Acute NL= Acute non

- endangered species (lowest LC50 X 0.5 ) = (0.13 X 0.5 = 0. 065 ) Acute L= Acute endangered listed species (lowest LC50 X 0.05) = (0.13 X 0.05 = 0.0065)

Chronic = Lowest invertebrate chronic NOEC

1 Acute comparison represents daily peak concentration from PRZM/EXAMS time series with Acute NL or Acute L endpo ints



### 4. 2 .2. Risks to Terrestrial Organisms

Risk to mammals and birds is estimated with the T

- REX model as discussed previously. The T

REX model assumes a default foliar dissipation half life of 35 days in the absence of available data showing a lowe r value. Traditional ground and aerial foliar spray uses are modeled as well

as seed treatment uses of flutolanil. The soil drench uses of flutolanil were not modeled in T

REX due the model being unable to simulate these types of uses. Further informati on can be

found in the uncertainties and limitations section.

4.2.2.1. Birds , Reptiles, and Terrestrial

- phase Amphibians

Potential risks to birds , reptiles, and terrestrial

- phase amphibians are evaluated using a cute and chronic toxicity data for the most sensitive bird species for which data are available, and the most sensitive dietary item and size class for that species.

The acute dose

- based RQs for birds, reptiles and terrestrial

- phase amphibians are uncertain given that they are expressed as bein g “less than,” values due to the fact that they are based on a non

-- Page 130 of 196

- 

### definitive “greater than,” L D 50 

### estimate s . While there is uncertainty in estimating risk from a

non

- d efinitive endpoint, even these upper bound RQs can be thought of as a “worst case,”

sce nario of risk as they represent what the RQ would be at most

.

The available acute oral toxicity study did not determine a definitive LD 50 

### as there were no

mortalities observed up to and including the highest treatment group (2000 mg a.i.kg

- bw). Despit e a LD 50 

### not being achieved , some use modeled in T

- REX estimate flutolanil residues several fold higher than the available toxicity study tested up to. While it cannot be definitively

stated that there is a true LOC exceedance for acute dose

- based risk to birds, some uses indicate

the potential to exceed an acute LOC based on the fact that the true LD 50 

### could lie anywhere above the 2000 mg a.i/kg

- bw threshold.

Worth noting is that all potential acute LOC exceedances for the food uses were below the acute high risk LOC of 0.5, that is, all potential exceedances were of the acute endangered species and acute restricted use LOC. For the turf and nursery stock uses, the potential to exceed all acute

LOCs was indicated.

The acute dietary

- based RQs for birds, reptiles and terrestrial

- phase and amphibians are uncertain in that they expressed as being “less than,” values due to the fact that they are based on

a non

- definitive “greater than,” LC 50 

### estimate s . While there is uncertainty in estimating risk

from a no n

- d efinitive endpoint, even these upper bound RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ would be at most

.

As for acute dose based risk to birds, the available avian dietary toxicity study did not show

mortalit y effects up to and including the top treatment concentration of 5243 mg a.i/kg

- diet). Therefore, when considering repeat applications and the persistence of flutolanil residues on terrestrial food items, some uses indicate the potential to exceed an acut e LOC based on T

- REX indicating the presence of a flutolanil residues higher than the 5243 mg a.i/kg

- diet threshold and

the fact that the true LC 50 

### lies somewhere above this value.

All turf and nursery stock (ornamental and fruit s, unspecified ) had the po tential to exceed at least

one acute LOC for at least one flutolanil contaminated food item

.

The potential for acute dietary based risk to birds was confined to the turf and nursery stock uses.

All food items had the potential of risk to exceed the le vel of the acute high risk LOC of 0.5 for all food items except fruits, pods, and seeds, as well as for arthropods for the golf course fairway use in Florida only. For the nursery stock uses, the potential for risk above the level of the 0.5

LOC was indic ated for multiple food items, again with fruits, pods, and seeds indicating potential risk below the level of the LOC.

Chronic dietary

- based RQs w ere determined using definitive NOAEC values from available avian reproduction studies and therefore the resu ltant RQs have a higher degree of certainty.

. There were 6 of 11 (55%) flutolanil uses that exceeded the chronic LOC for at least one food item. These uses were most of the turf uses as well as a nursery stock use. There were no LOC

exceedances for the golf course fairway in Florida use. The scenario that indicated most food- Page 131 of 196

- 

### item exceedances was the golf course greens, tees, and aprons use, with risk indicated to all food items except for fruits, pods, and seeds. For the nursery stock use, the lower ra te did not result in any LOC exceedances for all food items with the higher rate indicating risk above LOC to birds consuming all food items except fruits, pods, and seeds.

The effect at the LOAEC of the available avian reproduction studies show a reduc tion in eggs laid for one species and a reduction in eggshell thickness for the other species. Available terrestrial field dissipation studies show flutolanil half lives ranging from 27

– 81 days depending

on the study location and soil type. The default foliar dissipation half life value of 35 days was

used in T

- REX, which simulates exposure out to 105 days

. The results of the modeling indicate that flutolanil residues on food items are persistent enough to remain at or above the level of the

NOAEC for most turf and nursery stock uses modeled for the 105 day exposure that T

- REX

simulates

.

There were no acute or chronic exceedances of any LOC for birds for all seed treatment uses for flutolanil. Again

, these RQs are subject to the same uncertainty in r egards to being determined

with non

- definitive endpoints as broadcast applications were that are described earlier.

A study derived slope was not available and so the individual effect chance was estimated using the default slope of 4.5. The resultant c hance of effect was 1 in 4.8 X 10 8



### . Furthermore , there were no reported wildlife incidents for flutolanil involving birds in either the EIIS database or

the American Bird Conservancy maintained Avian Incident Monitoring System ( AIMS )

database.

4.2.2.2. Mammals

Potential risks to mammals are evaluated using T

- REX, acute and chronic toxicity data for laboratory rats, and the most sensitive dietary item and size class for that species. For mammals the most sensitive RQ in T

- REX is for the small mammal c onsuming short grass. The specific EECs for each species are for the same size mammals and same dietary items as those considered for acute exposure. Chronic effects are estimated using the lowest available NOAEC from a chronic study for mammals. Dietar y

- based EECs are divided by toxicity values to estimate chronic dietary

- based RQs.

The acute and chronic dose

- based and dietary

- based RQs for mammals are expressed as being “less than,” values due to the fact that they are based on a non

- definitive “grea ter than,” L D 50 

### and NOAEL estimate s, respectively . While there is uncertainty in estimating risk from a non

d efinitive endpoint, even these upper bound RQs can be thought of as a “worst case,” scenario of risk as they represent what the RQ would be at mos t

.

The available acute oral toxicity study for mammals did not determine a definitive LD 50 

### as there

were no mortalities observed up to and including the highest treatment group (5000 mg a.i.kg

bw). Despite a LD 50 

### not being achieved , some uses modeled in T

- REX estimate flutolanil residues higher than the available toxicity study tested up to when repeated applications and

foliar dissipation half life is considered. While it cannot be definitively stated that there is a true- Page 132 of 196

- 

### LOC exceedance for acute dose

- based risk to birds, some uses indicate the potential to exceed an

acute LOC based on the fact that the true LD 50 

### could lie anywhere above the 5000 mg a.i/kg

- bw

threshold.

In further characterizing the acute dose based RQs to mammals, there was no potenti al for risk above the level of the acute LOCs indicated for all food uses. For the turf uses, the potential for risk above the acute endangered species and acute restricted use LOCs were indicated for small and medium sized mammals consuming at least one flutolanil contaminated food item. Large mammals consuming short grass was determined to have the potential for risk above the LOC for the golf course greens, tees, and aprons use. For the nursery stock uses, only the high application rate modeled indica ted the potential for risk, with all RQs for all acute dose based

LOC potential exceedances being below the acute high risk LOC of 0.5 ( i.e. , only acute endangered species and acute restricted use LOCs could potentially be exceeded).

Similarly for chronic toxicity to mammals, available data did not indicate any effects up to and including the highest treatment concentration (20,000 mg a.i/kg

- diet, equivalent to 1936 mg a.i/kg

- bw/day) . Despite this, for two uses (turf and nursery stock), dose

- based chronic EECs returned results that would be above the level of the highest treatment concentration in the mammalian reproduction study (when foliar dissipation half life and repeat applications are taken into account). While a not a true LOC exceedance, the uses on turf and nursery stock have the potential to exceed the chronic LOC for dose

- based risk as the true NOAEC falls somewhere above the 1936 mg a.i/kg

- bw/day threshold. The potential to exceed the chronic LOC was not

indicated for all food uses and for th e turf uses, only the golf course greens, tees, and aprons use

had the potential to exceed for the LOC for small and medium sized mammals consuming short grass only. There was the potential for the RQ above the LOC indicated for the higher application rat e nursery stock use one for all size classes of mammals consuming at least one

flutolanil contaminated food item.

For c hronic dietary

- based RQs

, t here were no uses of flutolanil that had the potential to exceed the chronic LOC when expressed as dietary

- ba sed RQs.

There were no acute or chronic exceedances of any LOC for mammals for all seed treatment uses for flutolanil. Again these RQs are subject to the same uncertainty in regards to being

determined with non

- definitive endpoints as broadcast applica tions were that are described

earlier.

A study derived slope was not available and so the individual effect chance was estimated using the default slope of 4.5. The resultant chance of effect was 1 in 4.18 x 10 8



### . Furthermore , there were no reported wil dlife incidents for flutolanil involving mammals.

4.2.2.3. Terrestrial Invertebrates

Based on the available data for young adult honey bees, flutolanil is classified as practically

nontoxic to non

- target terrestrial invertebrates on an acute contact exp osure basis. Flutolanil was also shown to be practically n on toxic as residues on foliage. Currently there is no risk- Page 133 of 196

- 

### estimation process for non

- listed terrestrial invertebrates. An uncertainty with the terrestrial

invertebrate assessment is that the ava ilable toxicity study was conducted with a formulated product and not TGAI.

T here are n o reported incidents for terrestrial invertebrates associated with the application of

flutolanil have been reported.

4.2.2.4. Terrestrial Plants

Risk to terrestrial plants in dry areas and semi

- aquatic areas resulting from runoff and spray drift

of flutolanil was estimated using the TerrPlant (v.1.2.2) model. The TerrPlant derived EECs are compared to the most sensitive monocot and dicot EC 25 

### to generate a non

- liste d species RQ and compared to the most sensitive NOAEC or EC 05 

### to generate a listed species RQ. The listed and

non

- listed terrestrial plant LOC is 1. The most sensitive monocot in the vegetative vigor study was ryegrass with significant effect on weight a t the two lowest and two highest treatment concentrations. Consequently, an EC 25 

### and NOAEC value could not be determined and risk estimation to listed dicots resulting from spray drift only could not be conducted.

There was not a most sensitive dicot in dentified in the vegetative vigor study due to lack of toxicity and therefore the EC 25 

### was a “>” value. As a result, non

- listed RQs are preceded by a “<,” value to indicate a worst case scenario of risk. All endpoints from the seedling emergence study we re definitive.

The results of the risk estimation indicated that there were no LOC exceedances for nonlisted monocot plant species in all modeled areas resulting from multiple exposure routes. As mentioned previously, risk to listed species could not be estimated due significant effects on weight in the vegetative vigor study at all concentrations but the middle treatment concentrations. This pattern of the data precluded the regression model to converge and

therefore an EC 05 

### was not able to be estimated that would normally serve in place of a non

definitive (i.e. “<”) NOAEC value. For dicot species, risk above the level of the LOC was

indicated for listed species in semi

- aquatic areas resulting from exposures of runoff and spray

drift for all turf uses as well as the nursery stock use with the high application rate. Additionally, nonlisted dicots in semi aquatic areas and listed dicots in dry areas had risk indicated above the LOC for the golf course greens, tees, and aprons use.

4.2.2.5. Risk to Birds and Mammals as a Result of Bioaccumulation in

Food Items

As mentioned previously, a KABAM analysis was performed based on the log K OW 

### of flutolanil and the potential for the chemical to bioaccumulate in the tissues of aquatic organisms. Typically, the P RZM/EXAMS scenario that yields the highest pore and surface water

concentrations is used as the representative scenario to be protective of all uses of a given chemical. For flutolanil, that use was the soil drench application method for the nursery stock use. As a preliminary estimation of the RQs resulted in LOC exceedances with that use, additional uses were modeled to attempt to cover a range of residues that might be present in- Page 134 of 196

- 

### wildlife tissues. These uses included the ground spray method for the nu rsery stock use, the highest exposure turf scenario, the highest exposure rice scenario, and the highest exposure food crop scenario (NC peanuts).

The results of KABAM indicate that acute dose and dietary

- based RQs exceed the acute LOCs for birds only, and further only for certain uses. There were no chronic risk concerns above the

LOC for birds and no acute and chronic risk concerns above the LOC for mammals.

For the soil drench nursery stock scenario (the highest exposure scenario for flutolanil), acute dose based risk above the LOC was indicated for sandpipers and rails consuming flutolanil

contaminated organisms . Additionally, acute dietary based risk above the LOC was indicated for all modeled avian species. While the acute dose based RQs all h ad the potential to be above all acute LOCs (RQs ranged from < 0.49

– < 0.95 ), the dietary based RQs had the potential to exceed only the acute endangered species and acute restricted use LOCs (RQs ranged from < 0.10

–

< 0.20 ). As mentioned previously, there were no avian chronic risks and no acute or chronic

mammalian RQs with the potential to be above the LOC.

The same nursery stock use was modeled as a ground spray application method and the resultant RQs indicated that there was the potential to exceed the LOC for sandpipers and rails only. All RQs had the potential to exceed the acute endangered species and acute restricted use LOC only (RQs ranged from < 0.23

– < 0.44 ). The same potential exceedances findings were indicated (avian acute dose based for sandpipers and rails) for the rice use, although the RQs were lower (RQs ranged from < 0.12

– < 0.23 ). There were no potential acute or chronic LOC exceedances for birds and mammals for the turf and peanut uses.

The results of the KABAM analysis show that while some uses of flutolanil indicate avian acute dose based risk to two species resulting from the consumption of contaminated food items, this risk is restricted to the nursery stock use and highest exposure scenario use to rice. All food crops and tur f uses indicated a level of risk below all LOCs. The RQs from the modeled uses of KABAM suggest that while flutolanil has the potential to bioaccumulate, the depuration is rapid and fairly complete as the risk above the level of the acute high risk LOC (0 .5) was only indicated for one use and the highest exposure scenario method for that use (nursery stock soil drench). The same use modeled as a ground spray had risk findings indicated that exceeded only the acute endangered species and acute restricted u se LOCs for two species (sandpipers and rails). KABAM assumes that the sandpiper diet is roughly 1/3 each of benthic invertebrates, filter feeders, and small fish. For rails, that diet is assumed to be 50% benthic invertebrates and

50% small fish. The d ata and KABAM analysis indicate that flutolanil residues are depurated rapidly from fish tissue but there is no availabl e data to indicate the depuration rate from

invertebrates or other taxa.

Again , as mentioned previously in the risk characterization se ction , for acute risk estimation to birds and mammals, and chronic risk to mammals, RQs are stated to have the potential to exceed the LOC as a result of the submitted toxicity studies not indicating mortality up the top concentrations tested (2000 mg a.i/kg

- bw and 5000 mg a.i/kg

- bw for birds and mammals, respectively).- Page 135 of 196

- 

## 5

. Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine inf luence, 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 test s and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of Problem Formulation for the Registration review of Flutolanil, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p),

flutolanil is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

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

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E , A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal 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 available 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.

Under FFDCA section 4 08(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 5 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disru ptors.

Flutolanil is on List 1 for which EPA has received all the required Tier 1 assay data. The Agency is currently reviewing all of the assay data received for the appropriate List 1 chemicals and planning to make the conclusions of those reviews avai lable in early 2015.“ For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 6

6 http://www.epa.gov/endo/- Page 136 of 196

- 

## 6

. Federally Threatened and Endang ered (Listed) Species of

Concern

Based on this screening

- level assessment, there are potential risks of direct effects to listed birds, mammals, freshwater and estuarine/marine fish, invertebrates, and sediment dwelling invertebrates, aquatic vascular pla nts, and terrestrial dicot plant species from the use of flutolanil on some of its registered use sites. Listed species of birds, mammals, freshwater and

estuarine/marine fish and invertebrates taxa may also be affected through indirect effects because

of the potential direct effects on listed and non

- listed species. Potential direct effects on listed birds, mammals, freshwater and estuarine/marine fish, invertebrates, and sediment dwelling invertebrates, aquatic vascular plants, and terrestrial dicot pla nt species from the use of flutolanil may be associated with modification of P rimary C onstituent E lements (PCEs) of designated critical habitats, where such designations have been made. However, a t this current stage of the Registration Review process, it is premature to make effects determinations for listed species

until further scientific analysis and refinements are conducted , based on recommendations received from the National Academy of Sciences’ (NAS) National Research Council (NRC) April 2013 repor t, available at http://www.nap.edu/catalog.php?record_id=18344 . The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that are compliant with the Endangered Species Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The EPA along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectiv ely, the Services), and the U.S. Department of Agriculture (USDA), released a summary of their implementation plan for assessing risks of pesticides to listed species ahead of the stakeholder workshop held on November 15, 2013. This plan was developed in response to the NAS’ recommendations, including a common approach to risk assessment as a way of addressing scientific differences between EPA and the Services. During the workshop, the agencies received feedback from the public on the interim scientific approaches that were developed as part of the initial implementation of the NAS recommendations. These approaches will be jointly implemented and vetted as part of a phased iterative process. Once fully vetted, EPA will further refine the listed species effects determination portion of this risk assessment.

To make effects determinations for individual listed species, useful refinements may include, but are not limited to, analyses of: 1) more detailed, species

- specific ecological and biological data; 2) more detailed and accurate information on flutolanil use patterns; and 3) sub

- county level spatial proximity data for the co

- occurrence of potential effects areas and listed species and any designated critical habitat. Examples of such refinements are described below.

EFED is currently developing tools that are expected to further refine the assessment and are designed to support effects determinations for individual federally listed species and their designated critical habitats (where applicable). S cientific information obtained from the

Services , and other reliable sources is being collated by EFED to address all currently listed species. Th is information is be ing stored in an Office of Pesticide Programs (OPP) P esticide

R egistration I nformation S y ste M (PRISM) listed species knowledgebase. The listed species knowledgebase consist s of an information repository that houses biological and behavioral- Page 137 of 196

- 

### information relevant to individual species ( e.g. , habitat, diet, and life history, including specific

t emporal and spatial associations) and a document repository that contains supporting documents ( e.g ., USFWS recovery plans) and electronic information ( e.g ., GIS data files). For terrestrial taxa, biological information relevant to the assessment ( e.g ., d iet and body weight) will be used to parameterize exposure estimates using a method consistent with currently used methods in the

T

- REX and T

- HERPS models.

Refinements will also include more detailed analyses of the registered uses and specific use patt erns that result in either “Likely to Adversely Affect” (LAA) or “Not Likely to Adversely Affect” (NLAA) determinations for federally listed species. The analyses may include more information on where, when, and how flutolanil is used on all use sites

. A ctual usage data (when available) and national land

- cover datasets that indicate potential use sites [ e.g ., N ational L and

C over D ataset (NLCD), C rop land D ata L ayer (CDL)] may be used to support a more refined analysis of where flutolanil is reasonably expe cted to be used. Similarly, refinements on the timing of applications and a more in

- depth exploration of agronomic practices for flutolanil may be included as part of the refinement.

The refinements based on individual species data; additional, detailed usage information, when available; and recommendations from the NRC report are expected to help to more accurately identify potential areas of effect and to better inform effects and habitat determinations for listed species and any designated critical hab itats.

6 .1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by flu tolanil use and not merely the immediate area where flu tolanil is applied. At the initial screening

- level, the risk assessment considers broadly described taxonomic groups and conservatively estimates exposure for organisms that are co

- located with the pesticide treatment area. This means that terrestrial plants and wildlife are assumed to be located on or adj acent to the treated site and aquatic organisms are assumed to be located in a surface water body adjacent to the treated site , except in the case of direct application to aquatic

habitat

.

6

. 2

. Taxonomic Groups Potentially at Risk

If the assumptions as sociated with the screening

- level action area result in RQs that are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary. Furt hermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects on listed species that depend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may

extend to indirect effects u pon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species, the locations of- Page 138 of 196

- 

### these species, and the locations of use sites are considered to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentially include areas of expos ure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, the conceptual model s addressing proposed new flutolanil uses, and the associated exposure and effects analyses conducted for the flutolanil screening

- level risk assessment are in Sections 2 to 3 . The assessment endpoints used in the screening

- level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and sur vival, reproduction, and growth of aquatic and terrestrial plant species from both direct acute and chronic exposures. These assessment endpoints address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any ac tion they authorize does not appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQs) which, integrating exposure and ef fects, are calculated for broad based taxonomic groups in the screening

- level risk assessment presented in Section 4.

Both acute and chronic risk to listed species LOCs are considered in the screening

- level risk assessment to identify direct and indirect effects to taxa of listed species. This section identifies direct effect concerns, by taxa, that are triggered by exceeding listed species LOCs in the screening

- level risk assessment ( Table 6. ) , with an evaluation of the potential probability of individual effects for exposures that may occur at the established listed species LOC ( Table 6. )

. Data on exposure and effects collected under field and laboratory conditions are e valuated to make determinations on the predictive utility of the direct effect screening assessment findings to listed species. Additionally, the results of the screen for indirect effects to listed species, using

direct effect acute and chronic LOCs for each taxonomic group, is presented and evaluated.

Table 6. 1 . Potential Effects to Federally Listed Taxa Associated with Direct or Indirect

Effects from the Registered Uses of Flu tolanil

Listed Plant Taxon Direct Effects Indirect Effects to Listed

Taxon t hrough Direct

Effects on ...

Terrestrial and semi

- aquatic plants

– monocots and dicots Yes Birds, Mammals

Aquatic nonvascular plants Yes Fish 1

Aquatic vascular plants Uncertain 4 Aquatic nonvascular plants,

Fish 1

Listed Animal Taxon Direct Effects Indirec t Effects to Listed Taxon through Direct

Effects on ... Acute Chronic

Terrestrial invertebrates ND ND ND- Page 139 of 196

- Listed Plant Taxon Direct Effects Indirect Effects to Listed

Taxon t hrough Direct

Effects on ...

Mammals Yes Yes 3 Plants, Fish 1

, 2

Birds Yes Yes 3 Plants, Fish 1, 2

Reptiles Yes Yes 3 Plants

Amphibians Yes 1 Yes 3 Plants, Aquatic nonvascular plants, Fish 1

, Freshwater

invertebrates 1, Mammals

Freshwater fish Yes 1 Yes 3 Aquatic nonvascular plants,

Freshwater invertebrates 1

Freshwater invertebrates (crustaceans) Yes 1 No Aquatic nonvascular plants,

Fish 1

Molluscs Yes 1 ND Aquatic nonvascular plants,

Fish 1

Estuarine/marine fish No 5 No Aquatic nonvascular plants,

Estuarine/marine

invertebrates 1

Estuarine/marine invertebrates (crustaceans) Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

Freshwater benthic organisms Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

Estuarine/marine benthic organisms Yes 1 Yes 3 Aquatic nonvascular plants,

Fish 1

ND = Not determined

1 Acute risk exceeds the listed species LOC only for fish, aquatic amphibians, and aquatic invertebrates exposed to at least one registered use of flutolan il

2 Indirect effects to birds and mammals that eat fish or amphibians.

3 Chronic risk exceeds the LOC for at least one registered use of flutolanil

4 RQs for listed aquatic vascular plants are non

- definitive “>” values, with uncertain level of risk above wh at actual

determinations were.

5 Based on no mortality observed up to and including the limit of solubility.



### 6.3. Listed Species Occurrence Associated with Registered Uses

The screening

- level risk assessment for flu tolanil assumes that it may be applied nationwide, including U.S. territories and possessions. Therefore, no federally listed species are excluded from the screening level analyses, unless otherwise indicated ( e.g. , if only listed due to Similarity of Appearance to another listed species). A spatial co

- occurrence analysis that compares the best available data regarding flutolanil potential and documented use areas and listed species occurrence is needed to more explicitly address potential risk to listed species of concern. The- Page 140 of 196

- 

### Agency has req uested data to support this analysis from the Federal Endangered Species Task Force (FESTF ).



## 7. Conclusions

The risk hypothesis identified in the problem formulation stated

, g iven the registered uses of flutolanil, and its environmental fate properties ( persistence and low mobility), there is possible acute and chronic exposure to non

- target aquatic and terrestrial organisms. Previous risk assessments have identified risk to birds, and listed and non

- listed species of aquatic

estuarine/marine invertebrat es, including those living in the benthos. This assessment tests the hypothesis that, when used in accordance with the label, flutolanil exposure may result in adverse effects upon the survival, growth, and reproduction of non

- target aquatic and terrestr ial plants and animals. After reviewing the most recent environmental fate and effects data for flutolanil, the screening

- level assessment concludes that registered uses of the fungicide flutolanil may result in risk to both listed and non

- listed species of aquatic and terrestrial animals, aquatic plants and wildlife.

The main route of dissipation of flutolanil is through aerobic soil metabolism ( half

- lives 190

- 320 days). In laboratory tests, flutolanil was resistant to hydrolysis at all pHs tested and resistant to photolysis

, both in water (only 8% decline in 1 month) and on soils. Flutolanil also appears to be relatively persistent under anaerobic soil metabolism (representative half

- lives of ≥284 days),

and under aerobic and anaerobic aquatic metabo lism ( with half

- lives of greater than one year and greater than 13 years, respectively)

. When flutolanil is applied to the field, it is expected to reach crop canopy (via foliar applications or translocated since it is a systemic pesticide), and the soil (through incorporation on planted seeds, or foliar applications). Flutolanil can reach adjacent bodies of water through drift or runoff (dissolved or in eroded soil). Given the relatively high persistence of this chemical, and despite its relatively high K OC 

### s, it may also have the potential to leach to subsurfaces. Field dissipation studies appear to indicate that in the field various dissipation processes may occur. There are several terrestrial field dissipation studies and a long term study, which sh ow half

- lives of 27

- 126 days (excluding the second half

- life calculated for one of the studies for which a biphasic pattern was observed. Additionally, aquatic field dissipation studies yielded also a wide range of half

- lives of 63

- 303 and parent flutolan il remained mainly in the sediment. Flutolanil m ay be transported to surface water through erosion of soil particles containing bound flutolanil or dissolved in runoff water. Flutolanil does not have any major (>10%) degradation products. Desisopropyl f lutolanil ( DIP ) and other minor product s w ere less than 4% of the applied in all the environmental fate studies. DIP appears to be more mobile than the parent compound. Since it was only a minor product and it was often sporadically detected, EFED did no t include it as a stressor of concern. This is consistent with the HED’s approach.

When estimates of flutolanil exposure in terrestrial and aquatic environments are compared to the available ecotoxicity data, the results of the screening

- level assessment indicate a potential

for acute and chronic risk to birds and mammals , acute and chronic risk to freshwater fish and invertebrates, freshwater and estuarine/marine benthic invertebrates, listed and non

- listed species of aquatic vascular plants and the pote ntial of risk to listed aquatic vascular plants. While acute- Page 141 of 196

- 

### and chronic risk above the LOC was more widespread across all uses for aquatic species, terrestrial risk was mainly restricted to a few uses, that is, the nursery stock and certain turf uses.

Off

- site transport of flutolanil to surface water presents risk to listed and non

- listed species of aquatic nonvascular plants ( e.g. , algae); it is uncertain to what degree algicidal or algistatic effects in the aquatic plant community may result in indir ect effects to other organisms. While available data suggest that flutolanil is practically non

- toxic to bees, risk to listed species of terrestrial invertebrates cannot be precluded.

Flutolanil (with its low solubility and moderately high K OW 

### and K OC 

### s ) has the propensity to bind to the sediment. A screening level analysis has shown flutolanil to pose chronic risk above the LOC in both the pore water and sediment compartments. Depuration after termination of exposure was rapid with more than 95

- 99% of the total residue recovered depurated in 3 days.

These results would indicate a low propensity to bioconcentrate or bioaccumulate . A preliminary analysis shows that acute and chronic risk to birds and mammals consuming fish exposed to flutolanil is belo w levels of concern for most modeled scenarios , presumably based

on flutolanil’s readiness to depurate rapidly from tissues.

In the aquatic environment the input half

- lives used in modeling were indicative of high persistence as follows: stable to hydroly sis, stable to aqueous photolysis, 1095 days for aerobic aquatic metabolism (3X the available value), and stable to anaerobic aquatic metabolism. Evaluation of the results of the aquatic modeling shows an increasing trend of the EECs in

PRZM/EXAMS. There are a number of reasons why the estimated environmental exposure concentrations (EECs), and consequently the RQs, may have been conservative and possibly they are overestimates. These include: a) the PRZM/EXAMS input parameters may have been overly conse rvative, b) the field dissipation studies point towards lower persistence than noted

from the results of PRZM/ EXAMS, c) since the chemical shows medium to high pest resistance
[ as indicated by Fungicide Resistance Action Committee or FRAC for chemicals in Group 7 ] , it may not be applied as often as modeled in PRZM/EXAMS, and d) that the standard pond used in PRZM/EXAMS does not include flow or turnover, which may remove part of the flutolanil received in the pond. This may cause that, for moderately to hi ghly persistent chemicals, the chemical would build up with time and the model c ould overestimate EECs, when compared to real life concentrations in the environment for a similarly sized pond that does have an outlet that could remove portions of the fluto lanil received in the pond. While these facts appear to point towards lower persistence for flutolanil than used in the modeling, in the absence of additional

data there is uncertainty as to what degree there is persitance or no persistence for flutolanil

. Despite that they may have been conservative; the input values were used in the absence of

additional soils and sediments as per the current input parameter guidance. Therefore, there is uncertainty as to how much the EECs may have been overestimated.

Risk determinations for currently registered uses of flutolanil and proposed uses are shown in

Tables 7.1 and 7.2 , respectively. For currently registered uses, nursery stock poses potential risk to every taxon that RQs were estimated for. Furthermore, a ll currently registered uses except the seed treatment use to cotton and sugarbeet had RQs that exceeded acute and chronic LOCs for surface water and benthic estuarine/marine invertebrates. For proposed uses of flutolanil, the- Page 142 of 196

- 

### rice use had RQs that exceed ed acute and chronic LOCs for all assessed aquatic taxa. All proposed uses had RQs that exceeded acute and chronic LOCs for surface water and benthic estuarine/marine invertebrates. In addition, the proposed turf uses also had RQs that exceeded

acute and chronic LOCs for birds and mammals as well as listed and non

- listed terrestrial plants.- Page 143 of 196

- 

### Table 7 .1. Summary of Risk Determinations for Currently Registered Uses of Flutolanil (a bolded and shaded “ X ” represents an LOC exceedance) 9

Use (inclusive of all scenarios) FW fish FW

inverts E/M

Fish 8 E/M

inverts FW Benthic

inverts 5 E/M Benthic

Inverts 5 Birds 6 Mammals 6 Terrestrial plants 7 Aquatic plants 4AcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicListedNon-listedListedNon-listed

Peanuts 1 X X X X X X

Potato 2 X X X X X

Cotton Soybean X X X X Sugarbeet

Rice X X X X X X X X X X

Turf 3 X X X X X X X X X Nursery Stock X X X X X X X X X X X X X X X X X X

1 Inclusive of all use s except proposed ground banded application

2 Includes in

- furrow and seed treatment applications

3 Includes ornamental lawns and turf, recreation lawns, industrial, commercial, and residential lawns

4 Exceedances are for non

- listed non

- vascular plants

5 Chronic RQs inclusive of all potential compartments (sediment

- based, pore water

- based, pore water/surface water

- based)

6 Inclusive of both dose and dietary based risk an d of all terrestrial food items

7 Inclusive of both monocots and dicots

8 Acute and chronic risk to estuarine/marine fish was not estimated as there were no mortalities in the acute study up to solub ility limit and no chronic fish study

is available. An acu te

- to

- chronic ratio (ACR) was not utilized to estimate chronic toxicity as there is a high level of uncertainty in using an ACR wit h a non

definitive acute toxicity endpoint.

9 An italicized “ X ’ denotes that the acute or chronic exposure has the potential to exceed the LOC. See Risk Characterization section for more information.- Page 144 of 196

- 

### Table 7

. 2 . Summary of Risk Determinations for Proposed Uses of Flutolanil (a bolded and shaded “ X ” represents an LOC exceedance) 8

Use (inclusive of all scenarios) FW fish FW inverts E/M Fish 7 E/M inverts FW

Benthic

inverts 4 E/M

Benthic

Inverts 4 Birds 5 Mammals 5 Terrestrial plants 6 Aquatic plants 3AcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicAcuteChronicListedNon-listedListedNon-listed

Peanuts 1 X X X X X

Brassica (cole leafy vegetables plus turnip greens) X X X X X

Rice X X X X X X X X X X

Turf 3 X X X X X X X X X X X

1 Ground banded applications only

2 Includes golf courses, sod farms, spot fields, residential, institutional, municipal and commercial areas

3 Exceedances are for non

- listed non

- vascular plants

4 Chronic RQs inclusive of all potential compartments (sediment

- based, pore water

- based, pore water/surface wate r

- based)

5 Inclusive of both dose and dietary based risk and of all terrestrial food items

6 Inclusive of both monocots and dicots

7 Acute and chronic risk to estuarine/marine fish was not estimated as there were no mortalities in the acute study up to solu bility limit and no chronic fish study

is available. An acute

- to

- chronic ratio (ACR) was not utilized to estimate chronic toxicity as there is a high level of uncertainty in using an ACR wit h a non

definitive acute toxicity endpoint.

8 An italicized “ X ’ de notes acute or chronic exposure has the potential to exceed the LOC. See Risk Characterization section for more information.- Page 145 of 196

- 

## 8. Uncertainties, Limitations , and Identification of Data Gaps

8.1. Environmental Fate

8.1.1. Data Gaps Uncertainties

The enviro nmental fate database for flutolanil is substantially complete, as evidenced by the presence of all environmental fate laboratory and field studies. It is noted that for the aquatic metabolism studies, besides the fact that only one sediment in each study is available (usually

two sediments are required for a chemical ), the duration of these studies was very short compared to the calculated half

- lives. The aerobic aquatic metabolism study was conducted for a period of 30 days, compared to a half

- life of 1 year; meanwhile, the anaerobic aquatic metabolism study was conducted for 1 year, compared to a half

- life of >13 years. Therefore, the results were extrapolated and are highly uncertain. Furthermore, the aerobic soil metabolism for

three of four soils w as conducted for 180 days, compared to half

- lives of ≥190 days

, with the exception of one soi l that was conducted for 1 year . These issues bring uncertainty to the aquatic modeling results (see also Section 8.1.7 ).

8.1.2. Maximum Use Scenario

The scre ening

- level risk assessment focuses on characterizing potential ecological risks resulting from a maximum use scenario, which is determined from labeled statements of maximum application rate and number of applications with the shortest time interval betwe en applications. The frequency at which actual uses approach this maximum use scenario may be dependent on pest resistance, timing of applications, cultural practices, and market forces.

8.1.3. Aquatic Modeling with PRZM/EXAMS

The standard ecological water body scenario (EXAMS pond) used to calculate potential aquatic exposure to pesticides such as flutolanil is intended to represent conservative estimates, and to avoid underestimating the actual exposure. The standard scenario consists of applicatio n to a 10

- hectare field bordering a 1

- hectare, 2

- meter deep (20,000 m 3 

### ) pond with no outlet. Exposure estimates generated using the EXAMS pond is intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man

- made and natural ponds, and intermittent and lower order streams. As a group, there are factors that make these water bodies more or less vulnerable than the EXAMS pond. Static water bodies tha t have larger ratios of pesticide

- treated drainage area to water body volume would be expected to have higher peak EECs than the EXAMS pond. These water bodies will be either smaller in size or have larger drainage areas. Smaller water bodies

have limite d storage capacity and thus may overflow and carry pesticide in the discharge, whereas the EXAMS pond has no discharge. As watershed size increases beyond 10

- hectares, it becomes increasingly unlikely that the entire watershed is planted with a single cro p that is all treated simultaneously with the pesticide. Headwater streams can also have peak concentrations higher than the EXAMS pond, but they likely persist for only short periods of time and are then carried and dissipated downstream.- Page 146 of 196

- 

### The Agency ack nowledges that there are some unique aquatic habitats that are not accurately captured by this modeling scenario and modeling results may, therefore, under

- or over

- estimate exposure, depending on a number of variables. For example, some organisms may inh abit water bodies of different size and depth and/or are located adjacent to larger or smaller drainage areas than the EXAMS pond. However, the existing EXAMS pond represents the best currently available approach for estimating aquatic exposure to pestici des.

In general, the linked PRZM/EXAMS model produces EECs that are expected to be exceeded

once within a ten

- year period. The Pesticide Root Zone Model is a process or “simulation” model that calculates what happens to a pesticide in an agricultural fie ld on a day

- to

- day basis. It considers factors such as rainfall and plant transpiration of water, as well as how and when the pesticide is applied. It has two major components: hydrology and chemical transport. Water movement is simulated by the use of generalized soil parameters, including field capacity, wilting point, and saturation water content. The chemical transport component can simulate pesticide application on the soil or on the plant foliage. Dissolved, adsorbed, and vapor

- phase

concentrati ons in the soil are estimated by simultaneously considering the processes of pesticide uptake by plants, surface runoff, erosion, decay, volatilization, foliar wash

- off, advection, dispersion, and retardation.

Uncertainties associated with each of these i ndividual components add to the overall uncertainty of the modeled concentrations. Additionally, model inputs from the environmental fate degradation studies are chosen to represent the upper confidence bound on the mean values that are not expected to be exceeded in the environment approximately 90 percent of the time. Mobility input values are chosen to be representative of conditions in the environment. The natural variation in soils adds to the uncertainty of modeled values. Factors such as applicat ion date, crop emergence date, and canopy cover can also affect estimated concentrations, adding to the uncertainty of modeled values. Factors within the ambient environment such as soil temperatures, sunlight intensity, antecedent soil moisture, and surf ace water temperatures can cause actual aquatic concentrations to differ for the modeled values.

8.1

. 4

. Buffer Zone to Estuarine/Marine Bodies of Water for the Uses on

Turf

F or the uses on turf and application rates above 4.2 lb a.i./A, label s have restri ctions such as the following in the label of ProStar 70WP Fungicide : “ For use rates over 2

. 2 oz per 1,000 sq. ft. do not apply ProStar 70WP Fungicide within 100 ft

. of any estuary or marine habitat or within 100

ft

. of any ditches, drainage tiles

, or othe r waterways that drain directly into (within 

## 1⁄2 mile of

estuaries or marine habitats. ” As a refinement, the spray drift value for a buffer zone of 100 ft

towards freshwater bodies or 2,640 ft to estuarine/marine bodies of water for ground applications

was determined in AgDRIFT v.2.1.1

. Accordingly, the EECs are presented and compared in

Table 4.18 . As expected, the EECs decreased when the value of spray drift was decreased (around 15

- 16% for a buffer zone of 100 ft and 30

- 31% for a buffer zone of 2,640 ft

.

Unlike spray drift, tools are currently not available to evaluate the effectiveness of a setback on- Page 147 of 196

- 

### runoff and loadings. The effectiveness of setbacks is highly dependent on the condition of the vegetati on . For example, a well established, healthy veg etative setback can be a very effective means of reducing runoff and erosion from agricultural fields. Alternatively, a setback of poor vegetative quality or a setback that is channelized can be ineffective at reducing loadings. Until such time as a quan titative method to estimate the effect of vegetative setbacks on various conditions on pesticide loadings becomes available, the aquatic exposure predictions are likely to overestimate exposure where healthy vegetative setbacks exist and underestimate expo sure where poorly developed, channelized, or bare setbacks exist.

8.1. 5

. Uncertainties regarding dilution and chemical transformations in

estuaries

PRZM/EXAMS modeled EECs are intended to represent exposure of aquatic organisms in relatively small ponds a nd low

- order streams. Therefore it is likely that EECs generated from

the PRZM/EXAMS model will over

- estimate potential concentrations in larger receiving water bodies such as estuaries, embayments, and coastal marine areas because chemicals in runoff

wat er (or spray drift, etc. ) should be diluted by a much larger volume of water than would be found in the ‘typical’ EXAMS pond. However, as chemical constituents in water draining from

freshwater streams encounter brackish or other near

- marine

- associated co nditions, there is potential for important chemical transformations to occur. Many chemical compounds can undergo changes in mobility, toxicity, or persistence when changes in pH, E h 

### (redox potential), salinity, dissolved oxygen (DO) content, or temperatu re are encountered. For example, desorption and re

- mobilization of some chemicals from sediments can occur with changes in salinity ( Jordan et al. , 2008; Means, 1995; Swarzenski et al. , 2003) , changes in pH ( e.g ., Wood and Baptista 1993 ), E h 

### changes ( Veld e and Church, 1999; Wood and Baptista, 1993 ) , and other factors. Thus, although chemicals in discharging rivers may be diluted by large volumes of water within receiving estuaries and embayments, the hydrochemistry of the marine

- influenced

water may negat e some of the attenuating impact of the greater water volume; for example, the effect of dilution may be confounded by changes in chemical mobility (and/or bioavailability) in brackish water. In addition, freshwater contributions from discharging streams and rivers do not instantaneously mix with more saline water bodies. In these settings, water will commonly remain highly stratified, with fresh water lying atop denser, heavier saline water

– meaning that exposure to concentrations found in discharging s tream water may propagate some distance beyond the outflow point of the stream (especially near the water surface). Therefore, it is not assumed that discharging water will be rapidly diluted by the entire water volume within an estuary, embayment, or oth er coastal aquatic environment. PRZM/EXAMS model results should be considered consistent with concentrations that might be found near the head of an estuary unless there is specific information

– such as monitoring data

– to indicate otherwise. Condition s nearer to the mouth of a bay or estuary, however, may be closer to a marine

- type system, and thus more subject to the notable buffering, mixing, and diluting capacities of an open marine environment. Conversely, tidal effects (pressure waves) can propag ate much further upstream than the actual estuarine water, so discharging river water may become temporarily partially impounded near the mouth (discharge point) of a channel, and resistant to mixing until tidal

forces are reversed.- Page 148 of 196

- 

### The Agency does not cu rrently have sufficient information regarding the hydrology and hydrochemistry of estuarine aquatic habitats to develop alternate scenarios for assessed listed species that inhabit these types of ecosystems. The Agency acknowledges that there are unique

b rackish and estuarine habitats that may not be accurately captured by PRZM/EXAMS modeling results, and may, therefore, under

- or over

- estimate exposure, depending on the aforementioned

variables.

8.1. 6

. Aquatic Modeling with PFAM

The refined PFAM model provide s estimates of pesticide active ingredient in the water in the treated rice paddy, which is considered to constitute conservative concentration estimates for

w ater in rice production areas.

In running PFAM, the conservative assumption was employed , that no flooding events occurred prior to permanent flood. A common practice in rice production is to “flush” the fields 2

- 3 times between planting and establishment of the permanent flood, depending on the moisture level in soil ( BEAD’s internal memora ndum dated August 22, 2011 ). Such flushing would presumably act to partially remove flutolanil from soil/sediment, such that concentrations in paddy water during the permanent flood would be lessened. Because the model runs done using PFAM do

not account for this effect, modeled concentrations may be higher than concentrations in permanent flood waters of rice fields on which flushing has been conducted.

In modeling it was assumed that, once a permanent flood is established , and prior to chemical applica tion , the flood may be maintained until 2 to 3 weeks before harvesting, allowing for more exposure of flutolanil in the water. G iven its relative stability in the aerobic and anaerobic aquatic environment, the chemical concentrations may be higher than if the field was not permanently flooded.

In the PFAM modeling, upper 90 th 

### percentile confidence limits on mean half

- lives for degradation in unflooded soil were used for flutolanil , in accordance with EPA guidance. Use of

th ese values may exaggerate the stability of flutolanil in the soil compartment, thereby generating conservative E E C estimates for flutolanil

. Furthermore, three times the calculated

half

- lives of aerobic and anaerobic aquatic metabolism were used for such processes. Given the

observe d relative persistence of the chemical under such circumstances, the EECs may be

overestimated.

L abels also have restrictions for applications near marine/estuarine areas. For example, for Convoy ® 

### Fungicide , for the use on rice, the following statement i s shown in the supplemental

label: “ This pesticide is toxic to shrimp. Do not apply this product within three miles of any estuarine/marine waterways or watershed.” The actual EECs to which an estuarine/marine body of water would be exposed (and hence the RQs), are likely overestimated since PFAM cannot account for this type of buffer zone. The main processes that are expected to occur in transit to the estuarine/marine bodies of water are likely dilution and aerobic aquatic metabolism (half

- life is 1 yea r). Since residence times are unlikely to be very high, dilution may take an important role in the ‘dissipation’ of fl utolanil in such circumstances

.- Page 149 of 196

- 

### 8.1 .7

. Uncertainties Related to the Accumulation of Residues with Time

Evaluation of the results of the modeling shows an increasing trend of the EECs in PRZM/

EXAMS. There are a number of reasons why the estimated environmental exposure concentrations (EECs) may have been conservative and possibly they are overestimates. These include: a) that the PRZM/EX AMS input parameters may have been overly conservative due to the use of a 3X uncertainty factor on half

- lives which were in turn extrapolated from the study duration, b) that field dissipation studies point towards lower persistence than noted from the

re sults of PRZM/EXAMS both in the aquatic and terrestrial media, c) since the chemical belongs to FRAC Code 7 fungicides, and shows medium to high pest resistance it may not be applied as often as modeled in PRZM/EXAMS, where the maximum application rates an d minimum interval between applications were employed (i t appears that the chemical would not be used on the field for several consecutive years, or that there would not be many consecutive applications in a given year ), and d) the standard pond in PRZM/EX AMS does not have flow or water turnover which would have caused a portion of the chemical to be discharged away from the pond. This may cause that, for moderately to highly persistent chemicals, the chemical would build up with time and the model would o verestimate EECs, when compared to real life concentrations in the environment for a similarly sized pond that does have an outlet that could remove portions of the flutolanil received in the pond.

8.2. Ecological Effects

There are a number of areas of un certainty in the aquatic and terrestrial risk assessments. The toxicity assessment for terrestrial and aquatic plants and animals is limited by the number of species tested in the available toxicity studies. Use of toxicity data on representative species does not provide information on the potential variability in susceptibility to acute and chronic

exposures.

For each proposed use, the risk assessment is based on the maximum application rate on the proposed label. The frequency at which actual uses app roach these maximum scenarios is dependent on the resistance to the pesticide, the timing of applications, and market forces. Exposure and risks could be overestimated if the actual application rates, frequency of application, or number of applications are lower than the input parameters used for the conservative exposure scenario that was modeled. However, if there are conditions under which there is more than one growing season for a crop within a single year, exposure estimates and risk to aquatic and t errestrial organisms could be significantly underestimated.

Furthermore, there is uncertainty with some of the aquatic organism dataset for flutolanil. Several fish and aquatic invertebrate toxicity studies observed low to moderate percent

recoveries o f the test material with precipitate being observed in certain studies. Therefore, it is

uncertain about the bioavailability of flutolanil in the aquatic media which in turn may underestimate the toxicity of flutolanil to freshwater and estuarine/marine f ish and invertebrates as well as aquatic plants.- Page 150 of 196

- 

### 8.2.1. Terrestrial Exposure Assessment

This risk assessment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of flutolanil , maximum num ber of applications, and the shortest interval between applications. However, several uncertainties and model limitations are noted and should be considered in interpreting the results of this terrestrial

risk assessment.

8.2.1.1. Uncertainties Associated with T

- REX

There is uncertainty in the modeled terrestrial EECs and resultant RQs for a few flutolanil uses. Specifically, while T

- REX can simulate seed treatment scenarios, it does not allow for a seed planting depth to be specified. For the four flutolanil seed treatment uses, the label specifies a planting depth of 3⁄4 to 1 inch depending on the crop. T

- REX conservatively assumes that the treated seed is broadcast across the field without planting dept h and that 100% is available for consumption, differentiating itself from PRZM/EXAMS in which incorporation depth can be specified via the CAM input. As show in the risk estimation section however, there were no acute or chronic RQs above the LOC for bird s and mammals.

Additionally, there were a few flutolanil uses in which the soil drench method of application was specified. T

- REX cannot accurately simulate this type of exposure as it would assume the entire application rate would be sprayed on the fiel d and all terrestrial food items included. Label directions for soil drench methods usually advise the applicator to direct the spray so that no vegetative matter would be sprayed and therefore resultant EEC and RQs in T

- REX for these uses would be very c onservative and contrary to label directions. Therefore, these uses were not modeled but a conservative assumption would be to assume an equal measure of risk as the foliar spray application method for the same crops that soil drench is approved for use w ith.

Finally , there is uncertainty with T

- REX in how the model simulates systemic chemicals like

flutolanil. T

- REX only considered residues directly on terrestrial food items and therefore may

underestimate the concentration s within the plant.

8.2.2. Ro utes of Exposure

Dietary Exposure

Screening

- level risk assessments for spray applications of pesticides assume that 100% of the diet is relegated to single food types foraged only from treated fields. These assumptions are likely to be conservative for m any species and will tend to overestimate potential risks. The assumption of 100% diet from a treated area may be realistic for acute exposures, but long

- term exposures modeled as single food types composed entirely of material from a treated field is

unce rtain.- Page 151 of 196

- 

### Dermal Exposure

The screening assessment does not consider flutolanil dermal exp osure to terrestrial organisms. The Agency is actively pursuing modeling techniques to account for dermal exposure via direct application of spray and by incidenta l contact with contaminated vegetation, soil and water.

8.2.3. Age Class and Sensitivity of Effects Thresholds

It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant. The screening risk assessment acute toxicity data for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes. Similarly, acute dietary testing with birds is also performed on juveniles, with mallard being 5

- 10 days old and quail at 10

- 14 days of age.

Testing of juveniles may overestimate the toxicity of direct acting pesticides in adults. As juvenile organisms do not have fully developed meta bolic systems, they may not possess the ability to transform and detoxify xenobiotics equivalent to the older/adult organism. The screening risk assessment has no current provisions for a generally applied method that accounts for this uncertainty. In so far as the available toxicity data may provide ranges of sensitivity information with respect to age class, the risk assessment uses the most sensitive life

- stage information as the conservative screening endpoint.

8.2.4. Lack of Effects Data for Amphibia ns and Reptiles

Currently, toxicity studies on amphibians and reptiles are not required for pesticide registration. Since these data are lacking, the Agency uses fish as surrogates for aqu atic phase amphibians and birds as surrogates for terrestrial phase amphibians and reptiles. If other species are more or less

sensitive to flutolanil than the surrogates, risks may be under

- or overestimated, respectively. The Agency is not limited to a b ase set of surrogate toxicity information in establishing risk assessment conclusions. The Agency also considers toxicity data on non

- standard test species when available. Further research is needed to determine whether, in general, reptiles and

terrestri al

- phase amphibians are suitably represented by bird species in assessing risks for

flutolanil and fish are an appropriate surrogate for aquatic

- phase amphibians.

8.2.5. Use of the Most Sensitive Species Tested

Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does not necessarily mean that the selected toxicity endpoints reflect sensitivity of the most sensitive species existin g in a given environment. The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability among species to a particular chemical. The relationship between the sensitivity of the most sensitive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty. In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitiv ity and the most sensitive species tested.- Page 152 of 196

- 

### O ganisms consume a variety of dietary items and may exist in a variety of sizes at different life stages. For foliar applications of liquid formulations, T

- REX estimates exposure for the following dietary item s: short grass, tall grass, broadleaf plants/small insects, fruits/pods/seeds/ large insects, and seeds for granivores. Birds (used as a surrogate for amphibians and reptiles), and mammals, consume all of these items. The size classes of birds represent ed in T

- REX are the small (20 g), medium (100 g), and large (1000 g). The size classes for mammals are small (15 g), medium (35 g), and large (1000 g). EECs are calculated for the most sensitive dietary item and size class for birds (surrogate for terres trial

- phase amphibians and reptiles) and

mammals. Table 6

- 1 shows the percentages of the EECs and RQs of the various dietary classes for each size class as compared to the most sensitive dietary class (short grass) and size class (small mammal or bird). This information could be used to further characterize potential risk that is specific to the diet of birds and mammals. For example, if a mammal only consumes broadleaf plants and small insects and the RQ was 100 for small mammals consuming short

grass, the RQ for small mammals that only consumed broadleaf plants and small insects would be 56 (100 x 0.56).

Table 8.1. Percentage of EEC or RQ for the Specified Dietary Items and Size Classes as Compared to the EEC or RQ for The Most Sensitive Dietary Ite ms (Short Grass) and Size Class (Small Bird or Small Mammal)

Dietary Items Percentage of EECs or RQs for the Specified Dietary Items and Size Class as compared to the EEC or RQ for Small Birds 1 or Small Mammals Consuming Short Grass

Birds: Dose Based EEC s and RQs

Size Class Small, 20 g Mid, 100 g Large, 1000 g

EEC RQ EEC RQ EEC RQ

Short Grass 100% 100% 57% 45% 26% 14%

Tall Grass 46% 46% 26% 21% 12% 7%

Broadleaf plants/small

Insects 56% 56% 32% 25% 14% 8%

Fruits/pods/see ds/large insects 6% 6% 4% 3% 2% 1%

Granivores 1% 1% 1% 1% 0.4% 0.2%

Mammals: Dose

- Based EECs and RQs

Size Class Small, 15 g Mid, 35 g Large, 1000 g

EEC RQ EEC RQ EEC RQ

Short Grass 100% 100% 69% 85% 16% 46%

Tall Grass 46% 46% 32% 39% 7% 21%

Broadleaf plants/small

Insects 56% 56% 39% 48% 9% 26%

Fruits/pods/see ds/large insects 6% 6% 4% 5% 1% 3%

Granivores 1% 1% 1% 1% 0.2% 0.6%
Mammals and Birds: Dietary

- based EECs and RQs for all Size Classes 2

Short Grass 100%

Tall Grass 46%- Page 153 of 196

- Dietary Items Percentage of EECs or RQs for the Specified Dietary Items and Size Class as compared to the EEC or RQ for Small Birds 1 or Small Mammals Consuming Short Grass

Broadleaf plants/sm

Insects 56%

Fruits/pods/se e

ds/lg insects 6%

1 The percents of the maximum RQ shown here for birds are based on the Agency’s default avian scaling factor of

1.15.

2 Percentages for dose

- based chronic EECs and RQs for mammals are equivalent to the acute dose

- based EECs and RQs.



### In the risk assessment, RQs were only calculated for the most sensitive dietary class relevant to the organisms assessed. For most organisms, not enough data is available to conclude that birds or mammals may not exclusively feed on a dietary class for at least some time period. However, most birds and mammals consume a variety of dietary items and thus the RQ will overestimate risk to those organisms. Additionally, some organisms will not feed on all of the dietary classes. For example, many amphibians would only consume insects and not any plant material.

8.2.7. Sublethal Effects

When assessing acute risk, the screening risk assessment relies on the acute mortality endpoint as well as a suite of sublethal responses to the pesticide, as determined by t he testing of species response to chronic exposure conditions and subsequent chronic risk assessment. Consideration

of additional sublethal data in the effects determination is exercised on a case

- by

- case basis and only after careful consideration of the n ature of the sublethal effect measured and the extent and quality of available data to support establishing a plausible relationship between the measure of effect (sublethal endpoint) and the assessment endpoints. However, the full suite of sublethal

effe cts from valid open literature studies is considered for the characterization purposes.

To the extent to which sublethal effects are not considered in this assessment, the potential direct

and indirect effects of flutolanil on listed species may be undere stimated.- Page 154 of 196

- 

## 9. References

American Bird Conservancy (ABC). 2007. Avian Incident Monitoring System. Available

online at http://www.abcbirds.org/abcprogram s/policy/pesticides/aims/aims/simple.cfm

.

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.D., S.Z. Cohen, N.L. Barnes, J. Lam, and Q. Ma. 2010

. Urban Pesticides Risk Assessment and Management Review : Quantitative Analysis of Over 20 Years of Golf Course Monitoring Studies. Environmental Toxicology and Chemistry, Vol. 29, No. 6, pp. 1224

– 1236, 2010

.

Di Toro, DM, CS Zarba, DJ Hansen, WJ Berry, RC Swartz, CE Cowan, SP Pavlou, HE Allen, NA Thomas and PR Paquin. 1991. Technical basis for establishing sediment quality criteria for nonionic organic chemicals using equilibrium partitioning. Environ. Toxicol.

Chem. 10:1541

- 1583.

Fisher, H.B, List, E.J, Koh, R.C.Y., Imberger, J., and Brooks, N.H. (1979) Mixing in Inland and

Coastal Waters . Academic Press, Ney York, NY. pp. 126

- 127.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the

EPA food

- chain (Kenaga) nomogram, and instrument for estimating pesticide residues on plants. Environmental Toxicology and Chemistry 13 (9):1383

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Food and Agriculture Organization of the United Nations. FAO PESTICIDE DISPOSAL

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### 8 .1

. Submitted Environmental Fate Studies



## 161

- 1 Hydrolysis

MRID Citation Reference

40342940 Daly, D.; Ediger, K. (1987) W14 Hydrolysis of [Carbon 14]

- Fluto

- lanil as a Function of pH at 25 [degrees]C: ABC Final Report #35399. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 28 p.

No MRID 1988. Hydrolysis of Flutolonil in comparison wit Mepronil



## 161

- 2 Photodegradation

- water

MRID Citation Reference

41841208 Carpenter, M.; Fennessey, M. (1991) Determination of Photodegradat

- ion of [Carbon

14

- Flutolanil] in Aqueous Solution: Lab Project Number: 3 5176R: E642

- 01

- 87. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 41 p.

41841209 Bashir, M. (1991) Identification of Degradation Products of Flutol

- anil in an Aqueous Photosensitized Solution: Lab Project Number: 38426: E642.0 1.87. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 34 p.



## 161

- 3 Photodegradation

- soil

MRID Citation Reference

41841210 Carpenter, M. (1991) "Determination of the Photolysis Rate of Flut

- olanil on the
Surface of Soil": Lab Project Number: 38480: 500AU Unpublished study prepared by Analytical Bio

- Chemistry Laborato

- ries, Inc. 33 p.

43175810 Hallberg, C. (1994) Determination of the Photolysis Rate of Flutolanil on the Surface of Soil: Amendment 1: Lab Project Nu mber: 38480: 500AU. Unpublished study prepared by ABC Laboratories, Inc. 24 p.



## 162

- 1 Aerobic soil metabolism

MRID Citation Reference

40342941 Aizawa, H. (1982) W20

- Flutolanil: Decomposition Test of Flutolanil in Soil: Laboratory Project ID No. 56

- 076

- (3). Unpublished study prepared by Mitsubishi

Kasei Institute of Toxicological and Environmental Sciences. 38 p.- Page 159 of 196

- 40342942 Nakamura, Y.; Ishikawa, K.; Kuwatsuka, S. (1977) Degradation of benthiocarb in soils as affected by soil conditions. Jour nal of Pesticide Science 2:7

- 16.

45756601 Swanson, M. (1996) Aerobic Soil Metabolism of (Carbon 14)

- Flutolanil: Final Report: Lab Project Number: A55786/W70: SC920104: 520 AU. Unpublished study prepared by Battelle Columbus Operations. 137 p.



## 162

- 2 Anaerobic soil metabolism

MRID Citation Reference

49075001 Mallipudi, N.M. and L. Cooke. 2013. Anaerobic soil metabolism of [ 14 C] Flutolanil. Unpublished study performed by Eurofins Product Safety Labs (EPSL), Dayton, New Jersey, and Symbiotic R esearch LLC, Mount Olive, New Jersey; sponsored by Nihon Nohyaku Company Ltd., Tokyo, Japan; and submitted by Nichino America, Wilmington, Delaware. EPSL Study No.: 31754. Symbiotic Research Final Report No.: SR20130114A. Experiment started March 31, 2011, and terminated January 24, 2013 (p. 9). Final report issued February 26, 2013.



## 162

- 3 Anaerobic aquatic metab.

MRID Citation Reference

41841211 Daly, D.; Williams, M. (1991) Anaerobic Aquatic Metabolism of [Carbon 14]

- Flutolanil: Lab Projec t Number: 36762: E642.02.88. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 71 p.



## 162

- 4 Aerobic aquatic metab.

MRID Citation Reference

41841212 Daly, D. (1989) "Aerobic Aquatic Metabolism of [Carbon 14]

- Flutola

- n il: Lab Project Number: 36763. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 42 p.



## 163

- 1 Leach/adsorp/desorption

MRID Citation Reference

40342943 Daly, D. (1987) W13

- Soil/Sediment Adsorption

- Desorption with [Car

- bon 14]

- Flutolanil: ABC Final Report #35398. Unpublished study prepared by Analytical Bio

Chemistry Laboratories, Inc. 52 p.

41841213 Daly, D. (1991) “ Soil/Sediment Adsorption

- Desorption of Soil Incor

- porated [Carbon- Page 160 of 196

- 14]

- Flutolanil Following Aerobic Ag ing ” : Lab Project Number: 37793: E642.03.89. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 35 p.

42606626 Williams, M.; Heim, L. (1992) Soil/Sediment Adsorption

- Desorption of (Carbon 14)

- Desisopropyflutolanil: Lab Project Numb er: 40410. Unpublished study prepared by ABC Labs, Inc. 58 p.

42606627 Williams, M.; Berghaus, L. (1992) Soil/Sediment Adsorption

- Desorption of (Carbon 14)

- Flutolanil: Lab Project Number: 40130. Unpublished study prepared by ABC Labs, Inc. 58 p.



## 164

- 1 Terrestrial field dissipation

MRID Citation Reference

41837803 Castro, L. (1991) Dissipation of Flutolanil on Bare Soil Following Application of Flutolanil 50 WP, USA, 1989: Lab Project Number: R642.07.89. Unpublished study prepared by NOR

- AM Chemical Co. 63 p.

41837804 Castro, L. (1991) Dissipation of Flutolanil in Soil following Application of Flutolanil 50WP to Turf, USA, 1989: Lab Project Number: R642.10.89: 38122. Unpublished study prepared by Nor

- Am Chemical Co. in assoc. with ABC Labo ratories, Inc. 65 p.

42606616 Castro, L. (1991) Stability of Flutolanil and Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of Two Years: Lab Project Number: E642.05.88. Unpublished study prepared by NOR

- AM Chemical Co. 42 p.

4317 5809 Castro, L. (1993) Dissipation of Flutolanil in Soil Following Application of SN 84364 50WP To Peanuts, USA, 1988: Lab Project Number: R642.04.88. Unpublished study prepared by NOR

- AM Chemical Co. (Analytical Services Dept. and Residue Chemistry Dept.) . 84 p.

45756602 Castro, L. (1994) Dissipation of Flutolanil on Bare Soil Following Application of Flutolanil 50 WP: Lab Project Number: FLUTOLANIL/W43: R642.07.89: B002392. Unpublished study prepared by Nor

- Am Chemical Company. 97 p.

45756603 Castro, L. (1995) Dissipation of Flutolanil in Soil Following Application of Flutolanil 50 WP to Turf, USA, 1998: Lab Project Number: 38122: B002400: R642.10.89. Unpublished study prepared by ABC Laboratories, Inc. and AgrEvo Research Center. 117 p.

48714001 Wil loh, J.M. 2011. Independent laboratory validation of the flutolanil analytical method described in Nihon Nohyaku Co., Ltd. Final report no. LSRC

- A07

- 161A (amended), study protocol no. GE

- 04, 07

- 0127, entitled “Validation of analytical method for
flutolanil in soil.” Report prepared by Morse Laboratories, LLC, Sacramento, California, sponsored and submitted by Nihon Nohyaku Co. Ltd., Tokyo, Japan; 134 pages. Final report issued September 21, 2011.

48763101 Ihara, T. 2007. Validation of analytical method for flutolanil in soil. Report prepared by Nihon Nohyaku Co., Ltd., Osaka, Japan, sponsored and submitted by Nichino America, Inc., Wilmington, Delaware (p. 2); 32 pages. Final report issued December 7, 2007.- Page 161 of 196

- 

## 164

- 2 Aquatic field dissipation

MRID Cit ation Reference

42606616 Castro, L. (1991) Stability of Flutolanil and Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of Two Years: Lab Project Number: E642.05.88. Unpublished study prepared by NOR

- AM Chemical Co. 42 p.

42606 618 Castro, L. (1992) Aquatic Field Dissipation of Flutolanil following Use at Highest Recommended Label Rates in Rice: Lab Project Number: R642.06.89. Unpublished study prepared by NOR

- AM Chemical Co. and ABC Labs. 138 p.

43292603 Castro, L. (1993) Flut olanil/W62: Aquatic Field Dissipation of Flutolanil Following Application of MONCUT 50WP to Rice at Highest Recommended Label Rates, USA, 1991: Lab Project Number: AU/91R/03. Unpublished study prepared by NOR

- AM Chemical Co., Residue Chemistry Dept. 94 p.

48796401 Willoh, J.M. 2012. Independent laboratory validation of the flutolanil analytical method described in Nihon Nohyaku Co., Ltd. Final report no. LSRC

- A11

- 010A, study protocol no. GE

- 04, 11

- 0001, entitled “Validation of analytical method for flutol anil in

water.” Report prepared by Morse Laboratories, LLC, Sacramento, California, sponsored and submitted by Nihon Nohyaku Co. Ltd., Tokyo, Japan; 118 pages. Final report issued April 6, 2012.



## 164

- 3 Forest field dissipation

MRID Citation Referen ce

42606616 Castro, L. (1991) Stability of Flutolanil and Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of Two Years: Lab Project Number: E642.05.88. Unpublished study prepared by NOR

- AM Chemical Co. 42 p.



## 164

- 5 Long term soil dissipation

MRID Citation Reference

42606616 Castro, L. (1991) Stability of Flutolanil and Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of Two Years: Lab Project Number: E642.05.88. Unpublished study prepared by NO R

- AM Chemical Co. 42 p.

43175804 Castro, L. (1993) Long

- Term Field Dissipation of Flutolanil under Conditions of Peanut Cultivation Initiated 1989, USA: Lab Project Number: R642.08.89. Unpublished study prepared by NOR

- AM Chemical Co.; ABC Laboratories. 114 p.- Page 162 of 196

- 

## 165

- 1 Confined rotational crop

MRID Citation Reference

42606619 Downey, S.; Meyer, B. (1992) Uptake of (Carbon 14)

- Flutolanil Residues in Soil by Rotational Crops under Confined Conditions: Lab Project Number: E642.03.87. Unpublis hed study prepared by NOR

- AM Chemical Co. in cooperation with Landis Int'l and ABC Labs. 165 p.

1988 Confined crop rotation study protocol



## 165

- 2 Field rotational crop

MRID Citation Reference

42606616 Castro, L. (1991) Stability of Flutola nil and Desisopropyl Flutolanil in Soil under Freezer Conditions for a Period of Two Years: Lab Project Number: E642.05.88. Unpublished study prepared by NOR

- AM Chemical Co. 42 p.

43175803 Brady, S. (1994) Flutolanil

- Derived Residues in or on Rotational Crops Following Application of Moncut 50WP to Peanuts at Highest Recommended Label Rate: Lab Project Number: AU

- 91R

- 05. Unpublished study prepared by NOR

- AM Chemical Co. 241 p.

45702001 Winkler, V. (2002) Rotational Crop Plant Back Interval (PBI) Restric tions for Moncut Fungicide Use on Potatoes: Lab Project Number: VW030602: E642.03.87. Unpublished study prepared by Gowan Co. and Nichino America Inc. 21 p. {OPPTS 860.1900}

45709501 Winkler, V.; Chisholm, K. (2002) Rotational Crop Plant Back Interval (P BI) Restrictions for Moncut Fungicide Use on Potatoes: Lab Project Number: R

- 3052:
VW030602: E642.03

- 87. Unpublished study prepared by Gowan Co. 21 p. {OPPTS 860.1900}



## 165

- 3 Accumulation

- irrig crop

MRID Citation Reference

42606615 Castro, L. (1992) Residues of Flutolanil in Crops and Soil Irrigated with Water Drained from Rice Fields Treated with Flutolanil 50WP: Lab Project Number: R642.03.90. Unpublished study prepared by NOR

- AM Chemical Co. 89 p.- Page 163 of 196

- 

## 165

- 4 Bioaccumulation in f ish

MRID Citation Reference

40342944 Sudo, Y. (1984) W4

- Flutolanil: Test on the Degree of Bioaccumula

- tion of a, a, a

Trifluoro

- 3'

- isopropoxy

- o

- toouanilide (Test Sub

- stance No. S

- 837) in Carp: Report No. 35524E. Unpublished study prepared by Che micals Inspection & Testing Institute. 62

p.

41841214 Forbis, A. (1991) Uptake, Depuration and Bioconcentration of [Carb

- on 14]

- Flutolanil by Bluegill (Lepomis macrochirus): Lab Project Number: 37902: E642.04.89. Unpublished study prepared by Analy

- tic al Bio

- Chemistry Laboratories, Inc. 39 p.

41841215 Heitkamp, J. (1991) Characterization of [Carbon 14]

- Flutolanil Residues in Bluegill (Lepomis macrochirus) Water and Tissues: Lab Project Number: 38946: E642.04.89. Unpublished study prepa

- red by Analyti cal Bio

- Chemistry Laboratories, Inc. 58 p.

No MRID Fish Bioacculmulation Protocol related documents



## 165

- 5 Bioaccum

- aquatic non

- target

MRID Citation Reference

42641101 Brady, S. (1992) Flutolanil

- Derived Residues in or on Crayfish Grown in Rice Paddies Treated with Flutolanil 50 WP: Lab Project Number: R642.02.90. Unpublished study prepared by Nor

- Am Chemical Co. 132 p.



### 8 .2. Submitted Ecotoxicity Studies



## 71

- 1 Avian Single Dose Oral Toxicity

–

MRID DOC NUM Citation Reference

40342929 2049632 Roberts, N.; Fairley, C. (1986) W8

- The Acute Oral Toxicity (LD50) of Flutolanil to the Mallard Duck: Laboratory Project ID No. NNU 21BT/861566. Unpublished study prepared by Huntingdon Research Centre. 31 p.

40342930 2049629 Roberts, N.; Fairley, C. (1987) W9

- The Acute Oral Toxicity (LD50) of Flutolanil to the Bobwhite Quail: Laboratory Project ID No. NNU 20BT/861565. Unpublished study prepared by Huntingdon Re

search Centre. 31 p.



## 71

- 2 Avian Dietary Toxicity- Page 164 of 196

- MRID DOC NUM Ci tation Reference

40342931 2049630 Roberts, N.; Fairley, C. (1986) W10

- The Subacute Dietary Toxicity (LC50) of Flutolanil to the Mallard Duck: Laboratory Project ID No. NNu 23BT/861568. Unpublished study prepared by Huntingdon Research Centre. 28 p.

40342932 2049631 Roberts, N.; Fairley, C. (1986) W7

- The Subacute Dietary (LC50) of Flutolanil to the Bobwhite Quail: Laboratory Project ID No. NNU 22BT/861567. Unpublished study prepared by Huntingdon Research Centre. 29 p.



## 71

- 4 Avian Reproducti on

MRID DOC NUM Citation Reference

42932301 2049652 Beavers, J.; Hoxter, K.; Jaber, M. (1993) W64 Flutolanil: Flutolanil
Technical: A One

- Generation Reproduction Study with the Bobwhite (Colinus virginianus): Lab Project Number: 244

- 108. Unpublishe d study prepared by Wildlife International Ltd. 167 p.

42932302 2049653 Beavers, J.; Hoxter, K.; Jaber, M. (1993) W64 Flutolanil: Flutolanil
Technical: A One

- Generation Reproduction Study with the Mallard (Anas platyrhynchos): Lab Project Number: 244

- 109 . Unpublished study prepared by Wildlife International Ltd. 173 p.



## 72

- 1 Acute Toxicity to Freshwater Fish

MRID DOC NUM Citation Reference

40342933 2049633 Bowman, J. (1987) W16 Acute Toxicity of Flutolanil Technical to Rainbow Trout (Salmo gairdneri): ABC Final Report #35378. Un

published study prepared by Analytical Bio

- Chemistry Labora

tories, Inc. 143 p.

40342934 2049634 Bowman, J. (1987) W17 Acute Toxicity of Flutolanil Technical to Bluegill Sunfish (Lepomis macrochirus): ABC Final Report #35377. Unpublished study prepared by Analytical Bio

- Chemistry Labora

tories, Inc. 149 p.

40342936 2049635 Tsuchiya, K.; Sugimoto, T. (1982) W6

- Report on Flutolanil Toxicity Tests on Aquatic Organisms: Laboratory Project ID No. W

- 3001. Unpublishe d study prepared by Institute of Life Science Re

search. 35 p.- Page 165 of 196

- 41841216 2049638 Bowman, J. (1990) Acute Toxicity of Flutolanil Technical to Fathead Minnow (Pimephales promelas): Lab Project Number: 38101: E642.05 .89. Unpublished study prepared by Analy tical Bio

Chemistry Laboratories, Inc. 39 p.



## 72

- 2 Acute Toxicity to Freshwater Invertebrates

MRID DOC NUM Citation Reference

40342936 2049635 Tsuchiya, K.; Sugimoto, T. (1982) W6

- Report on Flutolanil Toxicity Tests on Aquatic Organisms: La boratory Project ID No. W

- 3001. Unpublished study prepared by Institute of Life Science Re

search. 35 p.

41841217 2049639 Hicks, S.; Young, B.; Forbis, A. (1990) Acute Toxicity of Flutolan

- il to Daphnia magna: Lab Project Number: 38718: E642.08.89. Un

published study prepared by Analytical Bio

- Chemistry Laboratori

es, Inc. 40 p.



## 72

- 3 Acute Toxicity to Estuarine/Marine Organisms

MRID DOC NUM Citation Reference

40342937 2049636 Chemicals Inspection & Testing Institute (1981) W5

- Flutolan il: Acute Toxicity of NHF

- 136 to Striped Mullet: Laboratory Project ID No. 34322E. Unpublished study. 9 p.

41841218 2049640 Bowman, J.; Gormley, M. (1991) Acute Toxicity of Flutolanil Technical to Sheepshead Minnow (Cyprinodon variegatus): Lab Project Nu mber: 38719: 502 AU. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 30 p.

41841219 2049641 Ward, T.; Boeri, R. (1991) Acute Flow

- through Mollusc Shell Deposi

- tion Test with Flutolanil: Lab Project Number: 9062

- AB:
E642.09 .89. Unpublished study prepared by Resource Analysts, Inc. 55 p.

41841220 2049642 Forbis, A. (1991) Acute Toxicity of Flutolanil to Mysidopsis bahia: Lab Project Number: 38720: E642.07.89. Unpublished study

prepa

- red by Analytical Bio

- Chemistry Laboratories , Inc. 44 p.

42606620 2049646 Bowman, J.; Friesen, K. (1992) Acute Flow

- through Toxicity of Flutolanil Technical to Crayfish: Lab Project Number: 39851. Unpublished study prepared by ABC Labs, Inc. 29 p.



## 72

- 4 Fish Early Life Stage/Aquatic Invert ebrate Life Cycle Study

MRID DOC NUM Citation Reference- Page 166 of 1 96

- 41841221 2049643 Rhodes, J.; Gormley, M. (1991) Early Life

- Stage Toxicity of Flutol

anil Technical to the Fathead Minnow (Pimephles promelas) Under

Flow

- Through Conditions: Lab Project Number : 38436: E642.06.89. Unpublished study prepared by Analytical Bio

Chemistry Laborato

- ries, Inc. 63 p.

41850807 2049645 Blakemore, G.; Burgess, D. (1991) 21

- Day Chronic Static Renewal Toxicity of Flutolanil to Daphnia magna: Flutolanil/W 48: Final Report #38721; 503 AU. Unpublished study prepared by Analytical

Bio

- Chemistry Laboratories, Inc. 51 p.

43511601 2049654 Boeri, R.; Kowalski, P.; Ward, T. (1995) Life

- Cycle Toxicity of Flutolanil to the Mysid, Mysidopsis bahia: Lab Project Number:
522AU: 481

- NI : W66. Unpublished study prepared by T.R. Wilbury Labs, Inc. 51 p.

43552001 2049655 Rhodes, J.; Muckerman, M. (1995) W69 Flutolanil: Early Life

- Stage Toxicity of Flutolanil to the Fathead Minnow (Pimephales promelas)

Under Flow

- Through Conditions: Final Report: Lab Project Number: 41685. Unpublished study prepared by ABC Labs, Inc. 176 p.



## 122

- 2 Aquatic plant growth

MRID DOC NUM Citation Reference

41841223 2049644 Bogers, M. (1990) Scenedesmus Subpicatus, Fresh Water Algal
Growth Inhibitio n Test with Flutolanil Technical: Lab Project Number: 024467. Unpublished study prepared by R C C Notox B.V. 25 p.

41841224 2049664 Hughes, J. (1990) The Toxicity of Flutolanil Technical to Selenast

rum capricornutum: Lab Project Number: B643

- 01

- 4: 507 AU. Unpu

- blished study prepared by Malcolm Pirnie, Inc. 25 p.

42606621 2049647 Hughes, J. (1990) The Toxicity of Flutolanil Technical to Anabaena

flos

- aquae: Lab Project Number: B643

- 01

- 5. Unpublished study prepared by Malcolm Pirnie, Inc. 23 p.

42606 622 2049648 Hughes, J. (1990) The Toxicity of Flutolanil Technical to Lemna gibba G3: Lab Project Number: B643

- 01

- 8. Unpublished study prepared by Malcolm Pirnie, Inc. 22 p.

42606623 2049649 Hughes, J. (1991) The Toxicity of Flutolanil Technical to
Skele tonema costatum: Lab Project Number: B643

- 01

- 7. Unpublished study prepared by Malcolm Pirnie, Inc. 23 p.

42606624 2049650 Hughes, J. (1991) The Toxicity of Flutolanil Technical to Navicula pelliculosa: Lab Project Number: B643

- 01

- 6. Unpublished study

pre pared by Malcolm Pirnie, Inc. 23 p.

42606625 2049651 Hughes, J. (1991) The Toxicity of Flutolanil Technical to Navicula pelliculosa at the Concentration Equivalent to the Maximum- Page 167 of 196

- Treatment Rate for Rice: Lab Project Number: B643

- 02

- 1. Unpublished study p repared by Malcolm Pirnie, Inc. 23 p.



## 141

- 1 Honey bee acute contact

MRID DOC NUM Citation Reference

40342938 2049637 Matsuura, M. (1987?) W3

- Flutolanil: Effects of Moncut Dry Flow

able on Honey Bee: Laboratory Project ID No. N3001. Unpubli shed study prepared by Mie University. 8 p.



## 141

- 2 Honey bee residue on foliage

MRID DOC NUM Citation Reference

40342939 2049637 Maezawa, Y.; Yamamoto, S. (1987?) W19

- Flutolanil: Effects of

Mon

- cut Against Honey Bee by Aerial Spray: Labora tory Project ID

No. N

- 3002. Unpublished study prepared by Agricultural Aerial

Tech

- nical Center, Japan Agricultural Aviation Association. 8 p.- Page 168 of 196

- Appendix 1 

### A ppendix A . PRZM/EXAMS Sample Input/Output Data

For NC Peanuts, In

- furrow Applications (at plant)

Water Column

stored as Flutolanil.out

Chemical: Flutolanil PRZM environment: NCpeanutSTD.txt modified Tueday, 29 May 2007 at 13:58:46 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06 :14:07

Metfile: w13722.dvf modified Tueday, 26 August 2008 at 06:14:27 Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 3.338 3.258 2.994 2.716 2.619 1.582

1962 4.973 4.914 4.807 4.54 4.404 3.359

1963 7.564 7.472 7.141 6 .786 6.598 5.377

1964 7.611 7.579 7.488 7.438 7.383 6.673

1965 13.52 13.35 12.82 12.28 11.89 9.451

1966 13.09 13.01 12.8 12.52 12.44 11.53

1967 16.41 16.28 16.03 15.54 15.27 13.58

1968 15.62 15.57 15.41 15.3 15.25 14.67

1969 16.52 16.46 16.28 16.06 16 15.3 2

1970 16.95 16.89 16.81 16.65 16.51 15.82

1971 19.95 19.85 19.47 19.22 19.05 17.53

1972 21.54 21.44 21.16 21 20.79 19.39

1973 23.83 23.7 23.3 22.72 22.39 20.89

1974 26.1 25.98 25.77 25.17 24.78 22.91

1975 25.05 24.98 24.73 24.3 24.13 23.52

1976 25.88 25.8 25.7 25.34 25.04 24.08

1977 25.63 25.56 25.33 24.92 24.76 24.46

1978 27.09 27 26.78 26.69 26.67 25.49

1979 26.84 26.79 26.66 26.49 26.46 25.84

1980 29.61 29.47 28.98 28.23 27.93 26.62

1981 28.38 28.31 28.08 27.85 27.79 27.14

1982 29.87 29.76 29.35 28.76 2 8.46 27.39

1983 29.08 29.01 28.84 28.45 28.18 27.33

1984 32.19 32.02 31.39 30.74 30.46 28.51

1985 29.43 29.38 29.2 29.15 29.07 28.68

1986 30.16 30.08 29.8 29.38 29.24 28.61

1987 29.07 29.01 28.92 28.68 28.56 28.3

1988 28.97 28.92 28.74 28.48 28.33 27.94

19 89 29.23 29.17 28.96 28.58 28.34 27.61

1990 30.9 30.79 30.37 29.8 29.52 28.15

Sorted results

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

0.032258064516129 32.19 32.02 31.39 30.74 30.46 28.68

0.0645161290322581 30.9 30.79 30.37 29.8 29.52 28.61

0.09677419 35483871 30.16 30.08 29.8 29.38 29.24 28.51

0.129032258064516 29.87 29.76 29.35 29.15 29.07 28.3

0.161290322580645 29.61 29.47 29.2 28.76 28.56 28.15

0.193548387096774 29.43 29.38 28.98 28.68 28.46 27.94

0.225806451612903 29.23 29.17 28.96 28.58 28.34 27.6 1

0.258064516129032 29.08 29.01 28.92 28.48 28.33 27.39

0.290322580645161 29.07 29.01 28.84 28.45 28.18 27.33

0.32258064516129 28.97 28.92 28.74 28.23 27.93 27.14

0.354838709677419 28.38 28.31 28.08 27.85 27.79 26.62

0.387096774193548 27.09 27 26.78 26.69 26.67 25.84

0.419354838709677 26.84 26.79 26.66 26.49 26.46 25.49- Page 169 of 196

- 0.451612903225806 26.1 25.98 25.77 25.34 25.04 24.46

0.483870967741936 25.88 25.8 25.7 25.17 24.78 24.08

0.516129032258065 25.63 25.56 25.33 24.92 24.76 23.52

0.548387096774194 25.05 24.98 2 4.73 24.3 24.13 22.91

0.580645161290323 23.83 23.7 23.3 22.72 22.39 20.89

0.612903225806452 21.54 21.44 21.16 21 20.79 19.39

0.645161290322581 19.95 19.85 19.47 19.22 19.05 17.53

0.67741935483871 16.95 16.89 16.81 16.65 16.51 15.82

0.709677419354839 16.52 16.46 16.28 16.06 16 15.32

0.741935483870968 16.41 16.28 16.03 15.54 15.27 14.67

0.774193548387097 15.62 15.57 15.41 15.3 15.25 13.58

0.806451612903226 13.52 13.35 12.82 12.52 12.44 11.53

0.838709677419355 13.09 13.01 12.8 12.28 11.89 9.451

0.8709677419354 84 7.611 7.579 7.488 7.438 7.383 6.673

0.903225806451613 7.564 7.472 7.141 6.786 6.598 5.377

0.935483870967742 4.973 4.914 4.807 4.54 4.404 3.359

0.967741935483871 3.338 3.258 2.994 2.716 2.619 1.582

0.1 30.131 30.048 29.755 29.357 29.223 28.489

Aver age of yearly averages: 20.2584

Inputs generated by pe5.pl

- Novemeber 2006

Data used for this run: Output File: Flutolanil

Metfile: w13722.dvf

PRZM scenario: NCpeanutSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Flutolanil Description Varia ble Name Value Units Comments Molecular weight mwt 323.3 g/mol

Henry's Law Const. henry 3.17E

- 9 atm

- m^3/mol

Vapor Pressure vapr 4.87E

- 8 torr Solubility sol 6.53 mg/L

Kd Kd mg/L

Koc Koc 780.7 mg/L Photolysis half

- life kdp 0 days Half

- life Aerobic Aquatic M etabolism kbacw 1095 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife

Aerobic Soil Metabolism asm 308.3 days Halfife Hydrolysis: pH 7 0 days Half

- life

Method: CAM 4 integer See PRZM manual Incorporation Depth: DEPI 2.54 cm Application Rate: T APP 0.832 kg/ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of application rate applied to pond Application Date Date 06

- 05 dd/mm or dd/mmm or dd

- mm or dd

- mmm
Record 17: FILTRA

IPSCND 1

UPTKF 0

Record 18: PLVKRT 0

PLDKRT 0

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)- Page 170 of 196

- 

### Pore Water

stored as Flutolanilben.out

Chemical: Flutolanil PRZM environment: NCpeanutSTD.txt modified Tueday, 29 May 20 07 at 13:58:46 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:07

Metfile: w13722.dvf modified Tueday, 26 August 2008 at 06:14:27 Benthic segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 2.243 2.243 2.2 42 2.239 2.233 1.245

1962 3.916 3.916 3.915 3.913 3.907 3.019

1963 6.01 6.009 6 5.962 5.938 4.995

1964 7.117 7.117 7.115 7.099 7.061 6.415

1965 10.51 10.51 10.51 10.51 10.5 8.758

1966 11.96 11.96 11.96 11.96 11.95 11.19

1967 14.31 14.31 14.31 14.3 14.29 13 .06

1968 14.86 14.86 14.85 14.84 14.83 14.49

1969 15.57 15.57 15.57 15.56 15.55 15.1

1970 16.03 16.03 16.03 16.02 16.01 15.61

1971 18.17 18.17 18.17 18.15 18.14 17.12

1972 20.04 20.04 20.04 20.02 20 18.95

1973 21.43 21.43 21.43 21.41 21.38 20.5

1974 23.57 23.57 23.57 23.55 23.52 22.45

1975 23.73 23.73 23.72 23.7 23.68 23.32

1976 24.37 24.37 24.37 24.34 24.31 23.84

1977 24.51 24.51 24.51 24.5 24.49 24.25

1978 26 26 25.99 25.96 25.93 25.2

1979 26.01 26.01 26.01 25.99 25.97 25.66

1980 27.09 27.09 27.08 27.06 2 7.04 26.25

1981 27.33 27.33 27.33 27.31 27.29 26.95

1982 27.73 27.73 27.73 27.7 27.66 27.16

1983 27.69 27.69 27.68 27.65 27.61 27.21

1984 29.2 29.19 29.19 29.17 29.13 27.99

1985 28.78 28.78 28.77 28.75 28.73 28.59

1986 28.81 28.81 28.81 28.79 28.77 28.45

1 987 28.44 28.43 28.41 28.36 28.33 28.17

1988 28.12 28.12 28.11 28.09 28.06 27.89

1989 27.85 27.85 27.85 27.82 27.79 27.48

1990 28.71 28.71 28.71 28.67 28.63 27.9

Sorted results

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

0.032258064516129 29.2 29.19 29.1 9 29.17 29.13 28.59

0.0645161290322581 28.81 28.81 28.81 28.79 28.77 28.45

0.0967741935483871 28.78 28.78 28.77 28.75 28.73 28.17

0.129032258064516 28.71 28.71 28.71 28.67 28.63 27.99

0.161290322580645 28.44 28.43 28.41 28.36 28.33 27.9

0.193548387096774 2 8.12 28.12 28.11 28.09 28.06 27.89

0.225806451612903 27.85 27.85 27.85 27.82 27.79 27.48

0.258064516129032 27.73 27.73 27.73 27.7 27.66 27.21

0.290322580645161 27.69 27.69 27.68 27.65 27.61 27.16

0.32258064516129 27.33 27.33 27.33 27.31 27.29 26.95

0.35483 8709677419 27.09 27.09 27.08 27.06 27.04 26.25

0.387096774193548 26.01 26.01 26.01 25.99 25.97 25.66

0.419354838709677 26 26 25.99 25.96 25.93 25.2

0.451612903225806 24.51 24.51 24.51 24.5 24.49 24.25

0.483870967741936 24.37 24.37 24.37 24.34 24.31 23.84

0 .516129032258065 23.73 23.73 23.72 23.7 23.68 23.32

0.548387096774194 23.57 23.57 23.57 23.55 23.52 22.45

0.580645161290323 21.43 21.43 21.43 21.41 21.38 20.5

0.612903225806452 20.04 20.04 20.04 20.02 20 18.95- Page 171 of 196

- 0.645161290322581 18.17 18.17 18.17 18.15 18.1 4 17.12

0.67741935483871 16.03 16.03 16.03 16.02 16.01 15.61

0.709677419354839 15.57 15.57 15.57 15.56 15.55 15.1

0.741935483870968 14.86 14.86 14.85 14.84 14.83 14.49

0.774193548387097 14.31 14.31 14.31 14.3 14.29 13.06

0.806451612903226 11.96 11.96 11.96 11.96 11.95 11.19

0.838709677419355 10.51 10.51 10.51 10.51 10.5 8.758

0.870967741935484 7.117 7.117 7.115 7.099 7.061 6.415

0.903225806451613 6.01 6.009 6 5.962 5.938 4.995

0.935483870967742 3.916 3.916 3.915 3.913 3.907 3.019

0.967741935483871 2.243 2.2 43 2.242 2.239 2.233 1.245

0.1 28.773 28.773 28.764 28.742 28.72 28.152
Average of yearly averages: 19.9737333333333

Inputs generated by pe5.pl

- Novemeber 2006

Data used for this run: Output File: Flutolanil

Metfile: w13722.dvf

PRZM scenario: NCpe anutSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Flutolanil Description Variable Name Value Units Comments Molecular weight mwt 323.3 g/mol

Henry's Law Const. henry 3.17E

- 9 atm

- m^3/mol

Vapor Pressure vapr 4.87E

- 8 torr Solubility sol 6.53 mg/L

Kd Kd mg/L

Koc Koc 780.7 mg/L Photolysis half

- life kdp 0 days Half

- life Aerobic Aquatic Metabolism kbacw 1095 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife

Aerobic Soil Metabolism asm 308.3 days Halfife Hydrolysis: pH 7 0 days Half

- life

Method: CAM 4 integer See PRZM manual Incorporation Depth: DEPI 2.54 cm Application Rate: TAPP 0.832 kg/ha Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of application rate applied to pond Application Date Date 06

- 05 dd/mm or dd/mmm or dd

- mm or dd

- mmm
Record 17: FILTRA

IPSCND 1

UPTKF 0

Record 18: PLVKRT 0

PLDKRT 0

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)- Page 172 of 196

- Appendix 2 

### Appendix B

. Example T

- REX (v. 1.5 .1 ) Input and Output for Flutolanil

Table B.1

. T

- REX Model Inputs: Chemical Application Scenarios and Body Mass for Assessed Species.

TREX MODEL INPUTS You must enable macros for this spreadsheet to work correctly These values will be used in the calculation of exposure estimates for foliar, granular, liquid and/or seed applications of pesticides.

Chemical Identity and Application Information

Chemical Name: Flutolanil Application Rate (lb
ai/ acre)

Seed Treatment? FALSE

Use: commerical and industrial lawns

Product name and form: % A.I. (leading zero must be

entered for formulations <1% a.i.): 100.00%

Application Rate (lb ai/acre) 5.94

Half

- life (days): 35

App lication Interval (days): 14

Number of Applications: 4 Are you assessing applications with variable
rates or intervals? no

You MUST scify application day in Columns F and G

- you may enter up to 30 applications

Assessed Species Inputs (opti onal, use defaults for RQs for national level assessments)

What body weight range is assessed (grams)? Birds Mammals

Small 20 15

Medium 100 35

Large 1000 1000- Page 173 of 196

- 

### Table B .2. Avian and Mammalian Toxicity Endpoints for RQ Calculation

.

Avian

Endpoint Toxicity value Indicate test species

below

LD50 (mg/kg

- bw)

2000.00 1

LC50 (mg/kg

- diet) 5243.00 1

NOAEL (mg/kg

- bw) 2

NOAEC (mg/kg

diet) 1920.00 1

Enter the Mineau et al. Scaling Factor 1.15

Mammalian

Acute Study Chronic Study Size (g) of mammal used in toxicity study Default rat body weight is 350 grams 350 350

Endpoint Toxicity value Reference (MRID)

LD50 (mg/kg

- bw) 10000.00

LC50 (mg/kg

- diet)

Reported Chronic Endpoint 20000.00

2 Is estimated daily dose (mg/kg

- bw) reported from the

available chronic mammal study? (yes or no) yes

Enter daily dose (mg/kg

- bw) 1936.00



### Table B .3. Avian Dose

- and Dietary

- based Upper Bound Kenaga EECs and RQs Based on the Registered Use of Flutolanil on Commercial and Industrial Lawns

.

Dose

- based EECs (mg/kg

- bw) Avian Classes and Body Weights (grams)

small mid large

20 100 1000

Short Grass 4493.33 2562.29 1147.17

Tall Grass 2059.44 1174.38 525.79
Broadleaf plants 2527.50 144 1.29 645.28- Page 174 of 196

- Fruits/pods 280.83 160.14 71.70
Arthropods 1759.89 1003.56 449.31

Seeds 62.41 35.59 15.93

Dose

- based RQs (Dose

- based EEC/adjusted LD50) Avian Acute RQs Size Class (grams)

20 100 1000

Short Grass 3.12 1.40 0.44

Tall Grass 1.43 0. 64 0.20
Broadleaf plants 1.75 0.79 0.25
Fruits/pods 0.19 0.09 0.03
Arthropods 1.22 0.55 0.17

Seeds 0.04 0.02 0.01



### T able B

. 4 . Mammalian Dose

- and Dietary

- based Upper Bound Kenaga EECs and RQs Based on the Registered Use of Flutolanil on Commercial a nd Industrial Lawns

.

Dose

- Based EECs (mg/kg

- bw) Mammalian Classes and Body weight

(grams)

15 35 1000

Short Grass 3761.56 2599.74 602.76

Tall Grass 1724.05 1191.55 276.26 Broadleaf plants 2115.88 1462.36 339.05 Fruits/pods 235.10 162.48 37.67 Arthropods 1473.28 1018.23 236.08

Seeds 52.24 36.11 8.37

Dose

- based RQs (Dose

- based EEC/LD50 or NOAEL) Small mammal Medium mammal Large mammal

15 grams 35 grams 1000 grams

Acute Chronic Acute Chronic Ac ute Chronic

Short Grass 0.17 0.88 0.15 0.76 0.08 0.40

Tall Grass 0.08 0.41 0.07 0.35 0.04 0.19 Broadleaf plants 0.10 0.50 0.08 0.42 0.04 0.23 Fruits/pods 0.01 0.06 0.01 0.05 0.00 0.03 Arthropods 0.07 0.35 0.06 0.30 0.03 0.16

Seeds 0.00 0.01 0.00 0.01 0.00 0.01

Dietary

- based RQs (Dietary

- based EEC/LC50 or NOAEC) Mammal RQs

Acute Chronic

Short Grass #DIV/0! 0.20

Tall Grass #DIV/0! 0.09 Broadleaf plants #DIV/0! 0.11 Fruits/pods/seeds #DIV/0! 0.01
Arthropods #DIV/0! 0.08- Page 175 of 196

- Appendix 3 

### Appendix C . Example Terrplant (v. 1.2.2) Input and Output for Flutolanil

Table 1. Chemical Identity.

Chemical Name Flutolanil

PC code 128975

Use ground Application Method Aerial

Application Form Spray Solubility in Water (ppm) 6.53

Table 2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.772 lbs a.i/A

Incorporation I 1 none

R unoff Fraction R 0.01 none

Drift Fraction D 0.01 none

Table 3. EECs for Flutolanil. Units in lbs a.i/A.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.00772

Runoff to semi

- aquatic areas (A/I)*R*10 0.0772 Spray drift A* D 0.00772 Total for dry areas ((A/I)*R)+(A*D) 0.01544

Total for semi

- aquatic areas ((A/I)*R*10)+(A*D) 0.08492

Table 4. Plant survival and growth data used for RQ derivation. Units are in lbs a.i/A.

Seedling Emergence Vegetative Vigor
Plant type EC 25 NOAEC EC 25 NOAEC

Monocot 3.66 2.2 8.17 8.17

Dicot 1.45 0.54 0.54 0.54

Table 5. RQ values for plants in dry and semi

- aquatic areas exposed to Flutolanil through runoff and/or spray drift.*

Plant Type Listed Status Dry Sem i

- Aquatic Spray Drift

Monocot non

- listed <0.1 <0.1 <0.1

Monocot listed <0.1 <0.1 <0.1

Dicot non

- listed <0.1 <0.1 <0.1

Dicot listed <0.1 0.16 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

Appendix 4- Page 176 of 196

- Appendix 5 

### Appendix D

. STIR Results

.

Input

Application and Chemical Information

Enter Chemical Name Flutolanil

Enter Chemical Use Ornamental

s Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 323.3 Enter Chemical Vapor Pressure (mmHg) 4.87E

- 08 Enter Application Rate (lb a.i./acre) 9.78

Toxicity Properties

**Bird**

Enter Lowest Bi rd Oral LD 50 (mg/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

**Mammal**

Enter Lowest Rat Oral LD 50 (mg/kg bw) 10000

Enter Lowest Rat Inhalation LC 50 (mg/L) 5.98 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35

Output

Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 8.47E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 1.07E

- 04

Adjusted Inhalation LD 50 6.67E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.60E

- 05 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 1.03E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 1.55E

- 01 Proceed to Refinements

Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 8.47E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 1.34E

- 04

Adjusted Inhalation LD 50 3.56E+02

Ratio of Vapor Dose to Adjusted Inhalation LD 50 3.76E

- 07 Exposur e not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 1.30E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 3.65E

- 03 Exposure not Likely Significant- Page 177 of 196

- Appendix 6 

### Appendix E

. SIP Result s

. Table 1. Inputs

Parameter Value

Chemical name Flutolanil

Solubility (in water at 25 o C; mg/L) 6.53

Mammalian LD 50 (mg/kg

- bw) 10000

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

M ammalian NOAEL (mg/kg

- bw) 1000

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

Avian LD 50 (mg/kg

- bw) 2000

Avian test species mallard duck
Body weight (g) of "other" avian species

Mineau scalin g factor 1.15

Mallard NOAEC (mg/kg

- diet) 1920
Bobwhite quail NOAEC (mg/kg

- diet) 1920
NOAEC (mg/kg

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

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

Table 2. Mammalian Results

Parameter Acute Chronic
Upper bound exposure (mg/kg

- bw) 1.1232 1.1232
Adjusted toxicity value (mg/kg

- bw) 7691.6057 769.1606
Ratio of exposure to toxicity 0.0001 0.0015

Conclusion * Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results

Parameter Acute Chronic
Upper bound exposure (mg/kg

- bw) 5.2893 5.2893

Adjusted toxicity value (mg/kg

- bw) 1038.4508 95.2561
Ratio of exposure to acute toxicity 0.0051 0.0555

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

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

- target animals.- Page 178 of 196

- Appendix 7 

### Appendix F . Classifications of Environmental Fate Studies Submitted for

Flu tolanil

Guideline

No Data Requirement Study

ID Study

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

835.2120 Hydrolysis 40342940 Acceptable N/A

835.2240 Photo lysis in

Water 41841208

41841209 Acceptable N/A

835.2410 Photodegradation

on Soil 41841210

43175810 Unacceptable Acceptable N/A

835.2370 Photodegradation

in Air No data

submitted N/A N/A

835.4100 Aerobic Soil

Metabolism 40342941

45756601 Acceptable Acceptable N/A

835.4200 Anaerobic Soil

Metabolism 49075001 Supplemental The results of the sandy loam (referred to as a loam in the study), sandier loamy sand, and clay loam are considered supplemental (upgradable). Insufficient data were provided regarding the soils used in this study, including source, collection and storage procedures, and whether they were free of pesticide residues prior to use. It is unknown if the soils are domestic or comparable to domestic soil at the intended use sites. The registrant should submit further characterization of the soils in order to upgrade the soils from supplemental to acceptable. For guidance on acceptability of soils, should they be of foreign origin, the registrant should consult the following URL (accessed 08/27/2013): http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/en vironmental_fate_tech_team/soils_foreign.htm

. The loamy sand (referred to as a sandy loam in the study), had a pattern of decreasing material balance and did not appear to be a naerobic, given the high oxygen content in the water. These patterns were not present in the

other three soils. EFED has low confidence in the results for this soil and considers them unacceptable. However, at this time given the high persistence demons trated in the other supplemental soils, and the low levels of transformation products, EFED believes that a new soil will not provide significant additional information. Therefore, no data on additional soils will be required.

835.4300 Aerobic Aquatic

Me tabolism 41841212 Acceptable N/A

835.4400 Anaerobic Aquatic

Metabolism 41841211 Acceptable N/A

835.1230 Leaching

Adsorption/ Desorption 42606626

42606627

40342943

41841213 Acceptable Acceptable Acceptable Acceptable N/A

835.1410 Laboratory

Volatil ity No data

submitted N/A N/A

835.6100 Terrestrial Field Dissipation 41837803

43175804

43175809

45756603

45756602 Unacceptable Acceptable Supplemental Acceptable Acceptable N/A

835.6100 Long

- term Soil Dissipation 43175804 Supplemental N/A

835.6200 Aqua tic Dissipation 42606618

43292603 Acceptable Unacceptable N/A

835.6 3 00 Forestry No data

submitted N/A N/A- Page 179 of 196

- Guideline

No Data Requirement Study

ID Study

Classification Classification Justifications or Comments (for Supplemental and Unacceptable Studies)

835.6 4 00 Combination and

Tank Mixes No data

submitted N/A N/A

860.1400 Accumulation in Irrigated Crops 42606615 Acceptable N/A

850.1730 Accumulati on in

Fish 40342944

41841214

41841215 Acceptable Acceptable Acceptable N/A

850.1950 Aquatic Non

target Organism 42641101 Acceptable N/A

835.7100 Ground Water Monitoring No data

submitted N/A Waived on 2/22/95 (DP Barcode D207449)

835.8100 Field Volatili ty No data

submitted N/A N/A

Non

guideline Storage Stability 42606616 Acceptable N/A

850.6100 Environmental Chemistry Methods (ECM)/ Independent Laboratory Validation (ILV)

in Soil 48714001

; 48763101 Supplemental The determination of the LOD and LOQ wer e not based on scientifically acceptable procedures; the fortification procedure was not reported; example calculations were incomplete; validation sample sets did not include a reagent blank; and a phone conversation between the ECM and ILV

laboratories d uring the trial was not documented.

850.6100 Environmental Chemistry Methods (ECM)/ Independent Laboratory Validation (ILV)

in Water 48796401 Supplemental The determination of the LOD/LOQ was not based on scientifically acceptable procedures; example cal culations were incomplete; ECM validation sample sets did not include a reagent blank; and matrix characterization of the river water in the ECM was incomplete. The registrant should provide a separate ECM, with signed and dated Data Confidentiality state ment.

N/A = Not applicable- Page 180 of 196

- Appendix 8 

### Appendix G . Classifications of Ecological Effects Studies Cited in the Risk

Assessment for Flutolanil

Guideline

Subdivision J

(OCSPP) Data Requirement MRID Classification Classification Justification (for Supplemental or Unacceptable Studies)

850.2100 Avian Acute Oral 40342929

40342930 Acceptable Acceptable NA

850.2200 Avian Sub

- acute Dietary 40342931

40342932 Acceptable Acceptable NA

850.2300 Avian Reproduction 42932301

4293230 2 Accep table Acceptable NA

850.1075 Freshwater Fish

– Acute Toxicity 40342933

40342934

40342936

41841216 Acceptable Supplemental Supplemental

Acceptable MRID 40342934 : Definitive LC 50 not achieved

MRID: 40342936 : Use of non

guideline species

850.1010 Freshwater Invertebrate

– Acute Toxicity 41841217

42606620 Acceptable Supplemental MRID 42606620: Use of non

guideline species

850.1075 Estuarine/Marine Fish

– Acute Toxicity 41841218 Acceptable NA

850.1025

850.1035 Estuarine/Marine

Invertebrate

– Acute

Toxicit y 41841219

41841220 Acceptable Acceptable NA

850.1300 Freshwater Invertebrate

– Life Cycle Test 41850807 Acceptable NA

850.1350 Estuarine/Marine

Invertebrate

– Life Cycle Test 43511601 Acceptable NA

850.1400 Freshwater Fish

– Early Life Stage Test 4355 2001 Acceptable NA

850.4225 Terrestrial Plant Toxicity

– Seedling Emergence, Tier I 48603202 Supplemental Poor emergence in controls and treatments confounded ability to assess effect no height and weight

850.4250 Terrestrial Plant Toxicity

– Vegetative Vigor, Tiers I and II 48603201 Supplemental Most sensitive dicot species could

not be determiednbased on lack of definitive endpoints

850.4400 Vascular Aquatic Plant Toxicity, Tiers I and II 42606622 Acceptable NA

8 50.5400 Algal Toxicity Test,

Tiers I and II 41841224

42606621

42606623

42606624

42606625 Acceptable Acceptable Acceptable Acceptable Acceptable NA

850.3020 Honeybee acute contact toxicity 40342938 Acceptable NA- Page 181 of 196

- Guideline

Subdivision J

(OCSPP) Data Requirement MRID Classification Classification Justification (for Supplemental or Unacceptable Studies)

850.1735 Whole sediment acute toxicity invertebrates,

freshwater 48776801 Accep table NA

850.1740 Whole sediment acute toxicity invertebrates,

estuarine/marine 48802201 Acceptable NA



### \- Page 182 of 196

- 

### Appendix 9 Appendix H. KABAM Output

Table 11. Estimated concentrations of Flutolanil in ecosystem components.

Ecosystem Component Total
concentratio n (μg/kg

- ww) Lipid
normalized

concentratio

n (μg/kg

lipid) Contributio

n due to diet (μg/kg

ww) Contributio

n due to respiration (μg/kg

- ww) Water (total)* 1,161 N/A N/A N/A Water (freely dissolved)* 1,161 N/A N/A N/A Sediment (pore water)* 295 N/A N/A N/A Sediment (in solid)** 9,212 N/A N/A N/A
Phytoplankton 335,188 16759403 N/A 335,188.05 Zooplankton 246,238 8207937 511.26 245,726.87

Benthic Invertebrates 259,270 8642330 1, 291.31 257,978.60

Filter Feeders 170,798 8539909 833.29 169,964.88

Small Fish 251,032 6275812 4,025.44 247,007.02

Medium Fish 192,549 4813735 4,892.91 187,656.49 Large Fish 130,636 3265894 3,807.65 126,828.12
* Units: μg/L; **Units: μg/kg

- dw- Page 183 of 196

- Table 12. Total BCFand BAF values of Flutolanil in aquatic trophic levels.

Trophic Level Total BCF (μg/kg

ww)/(μg/L) Total BAF (μg/kg

ww)/(μg/L)
Phytoplankton 297 289 Zooplankton 212 212

Benthic Invertebrates 222 223

Filter Feeders 147 147

Small Fish 286 216

Medium Fish 286 166 Large Fish 297 113

Table 13. Lipid

- normalized BCF, BAF, BMF and BSAF values of Flutol anil in aquatic trophic levels.

Trophic Level BCF (μg/kg

lipid)/(μg/L) BAF (μg/kg

lipid)/(μg/L) BMF (μg/kg

lipid)/(μg/kg

- lipid) BSAF (μg/kg

lipid)/(μg/kg

- OC)
Phytoplankton 14843 14435 N/A 73 Zooplankton 7058 707 0 0.49 36

Benthic Invertebrates 7415 7444 1.05 38

Filter Feeders 7327 7356 1.04 37

Small Fish 7148 5406 0.74 27

Medium Fish 7148 4146 0.65 21 Large Fish 7425 2813 0.68 14

Table 14. Calculation of EECs for mammals and birds consuming fish contaminated by

Flutolanil.
Wildlife Species Biological Parameters EECs (pesticide intake) Body Weight

(kg) Dry Food Ingestion Rate (kg

- dry

food/kg

bw/day) Wet Food Ingestion Rate (kg

wet food/kg

bw/day) Drinking

Water

Intake (L/d) Dose

B ased (mg/kg

bw/d) Dietary

Based (ppm)

Mammalian

fog/water shrew 0.02 0.140 0.585 0.003 151.897 259.27

rice rat/star

nosed mole 0.1 0.107 0.484 0.011 110.151 227.36

small mink 0.5 0.079 0.293 0.048 56.600 192.55

large mink 1.8 0.062 0.229 0.168 44.235 192.55- Page 184 of 196

- small river otter 5.0 0.052 0.191 0.421 36.887 192.55

large river otter 15.0 0.042 0.157 1.133 20.614 130.64

Avian
sandpipers 0.0 0.228 1.034 0.004 235.2144 227.27

cranes 6.7 0.030 0.136 0.211 28.2204 207.39

rails 0.1 0.147 0.577 0.010 147.4778 255.15

herons 2.9 0.040 0.157 0.120 35.6065 225.91

small osprey 1.3 0.054 0.199 0.069 38.4591 192.55

white pelican 7.5 0.029 0.107 0.228 13.9740 130.64

Table 14. Calculation of EECs for mammals and birds consuming fish contaminated by

Fluto lanil.
Wildlife Species Biological Parameters EECs (pesticide intake) Body Weight

(kg) Dry Food Ingestion Rate (kg

dry food/kg

bw/day) Wet Food Ingestion Rate (kg

wet food/kg

bw/day) Drinking

Water

Intake (L/d) Dose

Based (mg/kg

bw/d) Dietary

Based (ppm )

Mammalian

fog/water shrew 0.02 0.140 0.585 0.003 151.897 259.27

rice rat/star

nosed mole 0.1 0.107 0.484 0.011 110.151 227.36

small mink 0.5 0.079 0.293 0.048 56.600 192.55

large mink 1.8 0.062 0.229 0.168 44.235 192.55

small river otter 5. 0 0.052 0.191 0.421 36.887 192.55

large river otter 15.0 0.042 0.157 1.133 20.614 130.64

Avian
sandpipers 0.0 0.228 1.034 0.004 235.2144 227.27

cranes 6.7 0.030 0.136 0.211 28.2204 207.39

rails 0.1 0.147 0.577 0.010 147.4778 255.15- Page 185 of 196

- herons 2.9 0.040 0 .157 0.120 35.6065 225.91

small osprey 1.3 0.054 0.199 0.069 38.4591 192.55

white pelican 7.5 0.029 0.107 0.228 13.9740 130.64

Table 15. Calculation of toxicity values for mammals and birds consuming fish contaminated by Flutolanil.

Wildlife Species Toxicity Values

Acute Chronic

Dose

Based (mg/kg

bw) Dietary

Based (mg/kg

- diet) Dose Based (mg/kg

- bw) Dietary

Based (mg/kg

diet)

Mammalian fog/water shrew 20999.01 0.00 2099.90 20000

rice rat/s tar

nosed mole 14244.99 0.00 1424.50 20000

small mink 9391.04 0.00 939.10 20000

large mink 6640.47 0.00 664.05 20000

small river otter 5143.69 0.00 514.37 20000

large river otter 3908.36 0.00 390.84 20000

Avian
sandpipers 1038 .45 5243.00 N/A 1920

cranes 2483.95 5243.00 N/A 1920

rails 1253.13 5243.00 N/A 1920

herons 2190.74 5243.00 N/A 1920

small osprey 1930.94 5243.00 N/A 1920

white pelican 2526.33 5243.00 N/A 1920

Table 16. Calculat ion of RQ values for mammals and birds consuming fish contaminated by Flutolanil.

Wildlife Species Acute Chronic

Dose

Based Dietary

Based Dose Based Dietary

Based

Mammalian- Page 186 of 196

- fog/water shrew 0.007 #DIV/0! 0.072 0.013

rice rat/star

n osed mole 0.008 #DIV/0! 0.077 0.011

small mink 0.006 #DIV/0! 0.060 0.010

large mink 0.007 #DIV/0! 0.067 0.010

small river otter 0.007 #DIV/0! 0.072 0.010

large river otter 0.005 #DIV/0! 0.053 0.007

Avian
sandpipers 0.227 0.043 N/A 0.118

cranes 0.011 0.040 N/A 0.108

rails 0.118 0.049 N/A 0.133

herons 0.016 0.043 N/A 0.118

small osprey 0.020 0.037 N/A 0.100

white pelican 0.006 0.025 N/A 0.068- Page 187 of 196

- 

### Appendix 10 Appendix I. PFAM Default Values

The following default input parameters were used in the PFAM analysis. These parameters are located on the Physical tab of PFAM version 0.7.

Mass Transfer Coefficient [m/s] represents the mass transfer coefficient betwee n the water column and the benthic zone. It accounts for all means of mass transport and is referenced to the surrogate driving force of aqueous concentration differences. It is a difficult parameter to

measure. Literature and EPA’s own calibrations sug gest a starting estimate of 10 - 8 

### m/s.

Leakage [m/d] represents the dissipation of the pesticide in the water column due to leakage of the water column through the benthic region. The model’s assumption s are that only aqueous

phase pesticide leaks into th e sediment

, the leakage rate is constant

, and only downward such that there is never leakage in the reverse direction ( i.e.

, into the water column). The default

value is 0 m/d.

Reference Depth [m] represents the depth that aquatic measurements were made when determining factors such as suspended solids, biota, and DOC [m]. This usually will be set to

0.1 m

.

Benthic Depth [m] is the depth of the benthic compartment. This is another parameter that is

difficult to estimate ; however, literature and EPA’s o wn calibrations suggest a value of about

0.05 m.

Benthic Porosity [unitless] is the poro sity of the benthic compartment, or por e space volume per total volume

. The d efault value is set to that used by the EPA standard farm pond , 0.50

.

Dry Bulk Density [g/cm 3 

### ] is the rationally defined bulk density: [mass of sediment per total volume of sediment]. The d efault value is set to that used by the EPA standard farm pond , 1.35 g/cm 3



### .

Foc Water Column SS [unitless] is the fraction of organic carbon associated with suspended

sediment. The d efault value is set to th at used by the EPA standard farm pond , 0.04

.

Foc Benthic [unitless] is the fraction of organic carbon associated with benthic sediment. The

d efault value is set to that used by the EPA standard farm p ond , 0.01

.

SS [mg/L] is the suspended mass in the water column. The d efault value is set to that used by the EPA standard farm pond , 30 mg/L

.

Water Column DOC [mg/L] represents the dissolved organic carbon concentration in the water

column. The d efault value is set to that used by the EPA standard farm pond , 5.0 mg/L . This parameter only affects the photolysis rate.

C hlorophyll, CHL [mg/L] represents the chlorophyll concentration in the water column. The- Page 188 of 196

- 

### d efault value is set to that used by the EPA st andard farm pond , 0.005 mg/L . This parameter only affects the photolysis rate.

Dfac [unitless] is a parameter used in the model EXAMS. It represents th e ratio of the optical path length to vertical depth. The d efault value is set to1.19 as s uggested by EX AMS

documentation

.

Q10 [unitless] is the Q10 value for metabolism. The default value is 2 , which is a typical value- Page 189 of 196

- 

### Appendix 11 Appendix J. HenryWin v.3.20 Output File and Calculation of Heat of Henry

The Heat of Henry or ent halpy of solvation is the enthalpy of phase change from aqueous solution to air solution (Joules/mole). This enthalpy can be approximated from the enthalpy of vaporization ( Schwarzenbach et al

. , 2005), estimates of which can be obtained from EPISuite

amon g other sources.

To estimate the e nthalp y of vaporization using EPI Suite software

, the software is o pen ed , then the HENRYWIN subprogram is selected on the left of the EPISuite screen. On the top menu of the HENRYWIN window item, S how Options is selected

, then Show Temperature Variation

with Results is selected

. T he chemical name of interest is entered and the Calculate button is pushed . EPISuite will give the temperature variation results in the form of an equation: HLC (atm

- m 3 

### /mole) = exp(A

- (B/T)) {T in K}. The enthalpy of vaporization is B (in Kelvin). The enthalpy of solvation ( i.e

. , heat of Henry in J oules/mol) is calculated by multiplying the gas constant (8.314 J/ K

- mol) by the enthalpy of vaporization for the compound (K).

For flutolanil , the h eat of Henry ( 54,872 J/mol) was calculated by multiplyin g the gas constant (8.314 J/mol

- K) by the compounds’ enthalpy of vaporization (6, 6 00 K) estimated by HenryWin (v3.20).

Equation to calculate the Heat of Henry: Heat of Henry = 6600 K x 8.314 J/K

- mol = 54872 J/mol

References

Schwarzenbach, R. P., Gschwend, P. M. an d Imboden, D. M. 2005. Environmental Organic Chemistry, John Wiley & Sons, Inc., Hoboken, NJ

.

The printout from HenryWin for flutolanil is presented below, with the temperature variation

r esults highlighted in red

.

Bond Est : 1.11E

- 009 atm

- m3/mole (1.12E

- 004 Pa

- m3/mole)
Group Est: Incomplete

SMILES : C(F)(F)(F)c1ccccc1C(=O)Nc2cccc(OC(C)C)c2

CHEM : Flutolanil

MOL FOR: C17 H16 F3 N1 O2

MOL WT : 323.32

------------------ --------- HENRYWIN v3.20 Results

--------------------------

Experimental Database Structure Match:

Name : Flutolanil

CAS Num : 066332

- 96

- 5
Exp HLC : 3.18E

- 09 atm

- m3/mole (0.000322 Pa

- m3/mole)
Temper : 25 deg C
Exp Ref : VP/WSOL

Henry LC Temperature Variation: Source: Similar compound slope analogy- Page 190 of 196

- HLC (atm

- m3/mole) = exp(2.5694

- ( **6600** /T)) {T in deg K}

Temp (C) atm

- m3/mole unitless Pa

- m3/mole

-------- ----------- -------- ---------- 0 4.19E

- 010 1.87E

- 008 4.25E

- 005

5 6.47E

- 010 2.84E

- 008 6.56E

- 005

10 9.84E

- 010 4.24E

- 008 9.97E

- 005

15 1.48E

- 009 6.24E

- 008 0.000149

20 2.18E

- 009 9.06E

- 008 0.000221

25 3.18E

- 009 1.3E

- 007 0.000322

30 4.58E

- 009 1.84E

- 007 0.000464

35 6.52E

- 009 2.58E

- 007 0.000661

40 9.18E

- 009 3.57E

- 007 0.00093

45 1.28E

- 008 4.9E

- 007 0.0013

50 1.76E

- 008 6.65E

- 007 0.00179

---------- +

--------------------------------------------- +

--------- +

---------- CLASS | BOND CONTRIBUTION DESCRIPTION | COMMENT | VALUE

---------- +

-------------------------------- ------------- +

--------- +

----------

HYDROGEN | 7 Hydrogen to Carbon (aliphatic) Bonds | |

- 0.8377 HYDROGEN | 8 Hydrogen to Carbon (aromatic) Bonds | |

- 1.2344 HYDROGEN | 1 Hydrogen to Nitrogen Bonds | | 1.2835 FRAGMENT | 2 C

- C | | 0.2326 FRAGMENT | 1 C

- Car | | 0.1619 FRAGMENT | 1 C

- O | | 1.0855 FRAGMENT | 3 C

- F | |

- 1.2553 FRAGMENT | 12 Car

- Car | | 3.1657 FRAGMENT | 1 Car

- CO | | 1.2387 FRAGMENT | 1 CO

- N | | 2.4261 FRAGMENT | 1 Car

- N | | 0.7304 FRAGMENT | 1 Car

- O | | 0.3473

---------- +

--------------------------------------------- +

--------- +

--------- -

RESULT | BOND ESTIMATION METHOD for LWAPC VALUE | TOTAL | 7.344

---------- +

--------------------------------------------- +

--------- +

---------- HENRYs LAW CONSTANT at 25 deg C = 1.11E

- 009 atm

- m3/mole

= 4.53E

- 008 unitless

= 1.12E

- 004 Pa

- m3/mole

-------- +

----------------------------------------------- +

------------ +

-------- | GROUP CONTRIBUTION DESCRIPTION | COMMENT | VALUE

-------- +

----------------------- ------------------------ +

------------ +

-------- | 1 Car (N)(Car)(Car) | ESTIMATE |

- 0.50 | 2 CH3 (X) | |

- 1.24 | 1 CH (C)(C)(O) | | 0.12 | 8 Car

- H (Car)(Car) | | 0.88 | 1 Car (C)(Car)(Car) | | 0.70 | 1 Car (Car)(Car)(O) | |

- 0.43 | 1 Car (Car)(Car)(CO) | |

- 0.84 | 1 O (C)(Car) | | 1.25 | MISSING Value for: C (F)(F)(F)(Car) | MISSING Value for: CO (N)(Car) | MISSING Value for: NH (Car)(CO)

-------- +

----------------------------------------------- +

------------ +

--------

RESULT | GROUP ESTIMATION METHOD for LOG GAMMA VALUE | INCOMPLETE |

- 0.06

-------- +

------------------------- ---------------------- +

------------ +

--------

------------------------------------------------------------------------------

Bond Est : 1.11E

- 009 atm

- m3/mole (1.12E

- 004 Pa

- m3/mole)
Group Est: Incomplete- Page 191 of 196

- SMILES : C(F)(F)(F)c1ccccc1C(=O )Nc2cccc(OC(C)C)c2

CHEM : Flutolanil

MOL FOR: C17 H16 F3 N1 O2

MOL WT : 323.32

--------------------------- HENRYWIN v3.20 Results

--------------------------

Experimental Database Structure Match:

Name : Flutolanil

CAS Num : 066332

- 96

- 5

Ex p HLC : 3.18E

- 09 atm

- m3/mole (0.000322 Pa

- m3/mole)
Temper : 25 deg C
Exp Ref : VP/WSOL

Henry LC Temperature Variation: Source: Similar compound slope analogy

HLC (atm

- m3/mole) = exp(2.5694

- (6600/T)) {T in deg K}

Temp (C) atm

- m 3/mole unitless Pa

- m3/mole

-------- ----------- -------- ---------- 0 4.19E

- 010 1.87E

- 008 4.25E

- 005

5 6.47E

- 010 2.84E

- 008 6.56E

- 005

10 9.84E

- 010 4.24E

- 008 9.97E

- 005

15 1.48E

- 009 6.24E

- 008 0.000149

20 2.18E

- 009 9.06E

- 008 0.000221

25 3.18E

- 009 1.3E

- 007 0.000322

30 4.58E

- 009 1.84E

- 007 0.000464

35 6.52E

- 009 2.58E

- 007 0.000661

40 9.18E

- 009 3.57E

- 007 0.00093

45 1.28E

- 008 4.9E

- 007 0.0013

50 1.76E

- 008 6.65E

- 007 0.00179

---------- +

--------------------------------------------- +

--------- +

---------- CLASS | BO ND CONTRIBUTION DESCRIPTION | COMMENT | VALUE

---------- +

--------------------------------------------- +

--------- +

----------

HYDROGEN | 7 Hydrogen to Carbon (aliphatic) Bonds | |

- 0.8377 HYDROGEN | 8 Hydrogen to Carbon (aromati c) Bonds | |

- 1.2344 HYDROGEN | 1 Hydrogen to Nitrogen Bonds | | 1.2835 FRAGMENT | 2 C

- C | | 0.2326 FRAGMENT | 1 C

- Car | | 0.1 619 FRAGMENT | 1 C

- O | | 1.0855 FRAGMENT | 3 C

- F | |

- 1.2553 FRAGMENT | 12 Car

- Car | | 3.1657 FRAGMENT | 1 Car

- CO | | 1.2387 FRAGMENT | 1 CO

- N | | 2.4261 FRAGMENT | 1 Car

- N | | 0.7304 FRAGMENT | 1 Car

- O | | 0.3473

---------- +

--------------------------------------------- +

--------- +

----------

RESULT | BOND ESTIMATION METHOD for LWAPC VALUE | TOTAL | 7.344

---------- +

--------------------------------------------- +

--------- +

---------- HENRYs LAW CONSTANT at 25 deg C = 1.11E

- 009 atm

- m3/mole

= 4.53E

- 008 unitless

= 1.12E

- 004 Pa

- m3/mole

-------- +

----------------------------------------------- +

------------ +

-------- | GROUP CONTRIBUTION DESCRIPTION | COMMENT | VALUE

-------- +

----------------------------------------------- +

------------ +

-------- | 1 Car (N)(Car)(Car) | ESTIMATE |

- 0.50 | 2 CH3 (X) | |

- 1.24 | 1 CH (C)(C)(O) | | 0.12 | 8 Car

- H (Car)(Car) | | 0.88 | 1 Car (C)(Car)(Car) | | 0.70 | 1 Car (Car)(Car)(O) | |

- 0.43- Page 192 of 196

- | 1 Car (Car)(Car)(CO) | |

- 0.84 | 1 O (C)(Car) | | 1.25 | MISSING Value for: C (F)(F)(F)(Car) | MISSING Value for: CO (N)(Car) | MISSING Value for: NH (Car)(CO)

-------- +

------------------------ ----------------------- +

------------ +

--------

RESULT | GROUP ESTIMATION METHOD for LOG GAMMA VALUE | INCOMPLETE |

- 0.06

-------- +

----------------------------------------------- +

------------ +

--------- Page 193 of 196

- 

### Appendix 12 Appendix K. Flu tolanil and its Minor Transformation Products of

Environmental Fate Studies

Common Name Chemical Name

SMILES Code Structure

Flutolanil
(Parent compound) CAS Name: N

- [3

- (1

- Methylethoxy)phenyl]

-
2

- (trifluoromethyl)benzamide

IUPAC Name: α
, α
, α

- Trifluoro

- 3′

- isopropoxy

- o

- toluanilide

SMILES code:

C(F)(F)(F)c1ccccc1C(=O)Nc2cccc(OC(C)C)

c2 

### F F

F O N H O

C H 3 

### C H 3

M

- 2

Anaerobic soil CAS name: NA

IUPAC name: α, α, α

- Trifluoro

- 4’

- hydroxy

3’

- isopropoxy

- o

- toluanilide

SMILES code:

CC(C)Oc1cc(ccc1O)NC(=O)c2ccccc2C(F)(F

) F F F

F O N H O

C H 3 C H 3

O H

Desisopropyl flutolanil

(DIP , M

- 4 ) (minor
degradate)

Aerobic soil

Anaerobic soil
Anaerobic aquatic CAS Name: N

- (3

- Hydroxyphenyl)

- 2

- (trifluoromethyl)benzamide

IUPAC Name: NA

SMILES code:

C2C=CC=C(C(F)(F)F)C=2C(=O)NC1C=CC

=C(O)C=1 F F

F O N H O H

M

- 6 or MDP (minor

d egradate)

Aerobic soil

Anaerobic soil CAS Name: N

- (3

- Methoxyphenyl)

- 2

- (trifluoromethyl)benzamide

IUPAC Name: α
, α
, α

- Trifluoro

- 3’

- methoxy

o

- toluanilide

SMILES code : COc1cccc(c1)NC(=O)c2ccccc2C(F)(F)F F F

F O N H O C H 3- Page 194 of 196

- 

### Common Name Chemical Name

SMILES Code Structure

M

- 11

Aerobic soil CAS Name: 2

- [3

- [[2

- (Trifluoromethyl)
benzoyl]amino]phenoxy] propanoic acid

IUPAC Name: NA

SMILES code: NA
F F

F O N H O C H 3

C O O H

M

- 7 or HMD

Aerobic soil metabolis m CAS Name: N

- (4

- Hydroxy

- 3

- methoxyphenyl)

- 2

- (trifluoromethyl)benzamide

( 4'

- hydroxy

- 3

- methoxy

- 2

- trifluoromethyl

benzanilide )

SMILES code: NA F F

F O N H O C H 3

O H

M

- 5 or HDP
Anaerobic aquatic CAS Name: N

- (3,4

- Dihydroxyphenyl)

- 2

- (trifluoromethyl)benzamide

3',4'

- dihydroxy

- 2

- trifluorotoluanilide

IUPAC Name: NA

SMILES code: NA F F

F O N H O H

O H

NA = Not available- Page 195 of 196

- 

### Appendix L. Rice Growing Practices

Greater than 90 % of the rice production in the United States occurs in Arkansas, California, Mississippi, Louisiana, and Texas. Rice has also b een grown in Florida, Illinois, Missouri, Oklahoma, and Tennessee 7 

### . Survey data from the National Agricultural Statistics Service (NASS) on rice acres planted in the United States for the year 201 3 are provided in Table L

- 1

.

Table L

- 1 . Summary of acres p lanted with r ice in 20 13 1

State Acreage Planted Percent Production (cwt) Percent

Arkansas 1,076,000 43.3 78,645,000 42.5

California 561,000 22.6 46,148,000 24.9

Louisiana 417,000 16.8 28,016,000 15.1
Mississippi 130,000 5.2 9,159,000 4.9

Missouri 156,000 6.3 10,725,300 5.8

Texas 145,000 9.8 12,384,000 6.7

United States 2,485,000

--- 185,077,000

--- 1 Based on survey data from the from the Quick Stats Database of the National Agricultural Statistics Service

available at http://quickstats.nass.usda.gov/results/6432EC45

- FA6F

- 3DE6

- A48F

- 98F1917AAEA8 (accessed 10/29/2013).



### In general, rice fields are prepared (disking and harrowing) prior to seeding in order to destroy winter vegetation and reduce the chance of seedling drift. The fields are then leveled in order to maintain a flood and reduce runoff. After land preparation, rice seeds are planted via water

seeding or dry

- seeding on well prepared seed beds. If dry

- seeded, the fields are then flushed with irrigation water to obtain a uniform seed germination and seedling emergence. In between planting and establishment of permanent flood (3 to 4 weeks after the seeding), fields may be

flushed several times t o maintain moisture in the soil. Once the permanent flood is established, it is maintained until 2 to 3 weeks before harvesting. Flooded water is released and fields are drained 2 to 3 weeks before harvesting to facilitate harvesting operations that use machines.

In California (Hill et al., 1998), rice is grown primarily in continuously flooded, flow

- through systems, where the rice is seeded by airplane into the water. However, the practice of dry seeding of rice in California has increased due to weed resistance issues (Hill et al. 2006) . Weed control begins within days of planting and continues until the canopy closes over. Flooded paddies are normally drained 2

- 3 weeks prior to harvest. Information from the University of

California Rice Research and Information Program states that paddy water depths typically range from four to greater than eight inches.

In the southeastern United States, rice can be planted via water

- seeding, drill

- seeded, or broadcast dry; however, most of the planting is via wat er

- seeding to control red rice. In dry seed planting, 4

- 6 weeks may elapse between planting and permanent flood establishment, although flooding fields immediately after seeding can improve weed control. A uniform flood depth of

7 Based o n 2007 census data from the Quick Stats Database of the National Agricultural Statistics Service available

at http://quickstats.nass.usda.gov (accessed October 31, 2013)

.- Page 196 of 196

- 

### less than four inches (1

- 2 inches is preferred) is usually maintained prior to rice emergence, and then the flood depth is increased to four inches (Shipp, 2002).

Typical planting and harvesting periods were collected from the USDA (2010) and are provided

in Table L

- 2 below.

Tab le L

- 2 . Typical planting and h arvesting d ates 1

State Planting Harvesting

Arkansas April 14

– May 1 Sep 9

– Oct 10

California May 1

- 25 Sep 15

– Nov 1

Louisiana March 28

– May 1 Aug 4

– Sep 15

Texas March 23

– April 26 Aug 7

– Sep 4 Mississippi April 18

– May 16 Sep 5

– Oct 6 1 Data from USDA (2010)