# Baseline Ecological Risk Assessment for the

N ewActive Ingredient - Flutriafol

IUPAC Chemical Name: RS)
- 2,4'
- difluoro
- a - (1H
- 1,2,4
-triazol
- 1
- yl methyl)benzhydryl alcohol

CAS Chemical Name: α - (2
- Fluorophenyl)
- α - (4
- fluorophenyl)
- 1H
- 1,2,4
-triazole
- 1
- ethanol

CAS Number: 76674
- 21
- 0 PC Code: 128940 Prepared by: U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch III 1200 Pennsylvania Ave., NW

Mail Code 7 507P Washington, DC 20460 Stephen Carey , Biologist Luc y Shanaman, Chemist Stephanie Sy slo, Environmental Scientist/RAPL Reviewed by: Mary Frankenberry , Statistician Brian Anderson, Biologist Mark Corbin , Senior Environmental Scientist Jim Hetrick, Seni or Environmental Scientist



# N N N C

H 2 

# O H F F2 TABLE OF CONTENTS I. EXECUTIVE SUMMARY......................................................... ................. 5 II. PROBLEM FORMULATION.................................. ............... ....................... 18 A. NATURE OF REGULATORY ACTION....................... .............. ................. 18 B. STRESSOR SOURCE AND DISTRI BUTION............................... ............ ... 18 1. Nature of the Chemical Stressor.......................................... ............ 18 2. Overview of Pesticide Usage................................. ............. .............. 2 0 C. RECEPTORS.......................................................... .................... ......... 2 0 1. Aquatic Effects.................................................... ......... ......... ...... 2 1 2. Terrestrial Effects........................................................ ................ 2 1 3. Ecosystem at Risk.................................................... .................. ... 2 3 D. ASSESSMENT ENDPOINTS.................................................... ............... 2 3 E. CONCEPTUAL MODEL...................................................... .................. 2 4 1. Risk Hyp othesis...................................................... ............... .... .. 2 4 2. Conceptual Model.......................... ........................ ................... ... 2 4 F. ANALYSIS PLAN............................................. ................. ............. 2 7 1. Preliminary Identification of Data Gaps and Methods............ .......... .... 2 7 2. Measures of Effects and Expo sure...................................... ............. 28 a. Measures of Exposure............................................. ............ 28 b. Measures of Effects ................................. .................. ......... 29 III. ANALYSIS.................................................................... ................... ....... 3 1 A. USE CHARACTERIZATION......................................... ............... ......... 3 1 B. EXPOSURE CHARACTERIZATION ...................................... ............ .... 3 2 1. Environmental Fate and Transportation Characterization.......... ......... ... 3 2 a. Summary of Environmental Fate of Flutriafol ................ ........ ... 3 2 b. Persistence and Transformation ........................... ........... ...... 3 3 c. Transport and Mobility....................................... ............ ... 3 4 d. Field Studies .............................. ........... ... ... ..................... 3 5 2. Measures of Aquatic Exposure.................................... ............. ....... 3 5 a. Aquatic Exposure Modeling ........................... ............. ......... 3 5 b. Modeling Results......................................................... ........... ..... .......... 3 6 c. Aquatic Exposure Monitoring and Field Data............... ......... ... 3 7 3. Measures of Terrestrial Exposure....................................... ............. 3 73 a. Terrestrial Exposure Modeling for Spray Applications...... ...... ... 3 7 4. Measures of Incidental Spray Drift Exposure................................ ......... ........ 4 1 C. ECOLOGICAL EFFECTS CHARACTERIZATION ............. .......... ............ 4 2 1. Aquatic Effects Characterization.................................... .............. ... 4 3 2. Terrestrial Effects Characterizatio n....................... ... ... ........... ......... 5 1 IV. RISK CHARACTERIZATION............................. .................. ........................... 57 A. RISK ESTIMATION

– INTEGRATION OF EXPOSURE AND EFFECTS DATA..................................................... ................. ............. 58 1. Non - target Aquatic Animals and Plants ................................. ........... 60 a. Fish ...................................................... ............... ......... 6 2 b. Invertebrates .............................. ............. ........................ 6 4 c. Aquatic Plants .......................................... ............... ......... 6 5 d. Aquatic - phase Amphibians................................................. ............. .... 67 2. Non - target Terrestrial Animals .............................. ............ ............ 67 a. Birds ............................................................ ............ ... 67 b. Mammals... ...................................................... ............... 7 1 c. Terrestrial - phase Amphibians and Reptiles....................... ................ 7 4 d. Beneficial Insects................................................................ ................... 7 4 3. Non - target Terrestrial Plants in Terrestrial and Semi- aquatic Environments ........................................................................... .... 7 4 B. RISK DESCRIPTION..................................................... ................ ........ 75 1. Risks to Aquatic Animals and Plants.................................. .............. .... 77 a. Aquatic Animals ................................................... ............ 77 b. Aquatic Plants ................................. ................ ............... 8 0 c. Aquatic - phase Amphibians.................................................... ........... .. 8 2 2. Risks to Non - target Terrestrial Animals and Plants.............. ... ......... .... 8 2 a. Terrestrial Animals............................................. ............. ... 8 2 b. Terrestrial Plants............................................. .... ... ......... ... 88 c. Terrestrial- phase Amphibians and Reptiles... ................. ................... 88 d. Beneficial Insects............................................ ................. ...................... 88 3. Review of Incident Data............................................. .............. ...... 89 4. Endocrine Effect s ........................................................ ................ 89 5. Federally Threatened and Endangered (Listed) Species Concerns ...... ...... 89 a. Action Area............................................. ............... ............ 89 b. Taxonomic Groups Potentially at Risk..................... ......... ....... 9 0

1. Discussion of Risk Quotients............... ....... ............... 9 1 2. Probit Dose Response Relationship................... ...... ... 9 2 3. Data Related to Under - represented........... ....... .......... 94 4. Implications of Sub - lethal Effects.... ....... ................... 94 c. Indirect Effect s Analysis..................... ......... .... .. .................. 94 d. Critical Habitat.............. ................. ............ ....................... 94 e. Direct Effect Co - occurrence Analysis....... ...... .......... ... ............ 95 f. Indirect Effect Co - occurrence Analysis.............. ......... .............. 964

C. ASSUMPTIONS, UNCERTAINTIES, STRENGTHS AND LIMITATIONS OF THE FLUTRIAFOL ASSESSMENT.................... ......... ........ .................. 97 REFERENCES......................................................................................... .......................... .............. 10 1 APPENDICES Appendix A. Environmental Fate Assessment and Data Summary ...... ..... ........................... 1 02 Appendix B. Aquatic Exposure Modeling and Results (GENEEC2 and PRZM/EXAMs ) ......... 1 37 Appendix C. Aquatic Risk Quotients................................. .................. ........................ 1 4 7 Appendix D. Terrestrial Birds and Mammals Exposure Modeling and Results (TREX v1.3.1) ... 1 50 Ap pendix E. Terrestrial Plants Exposure Modeling and Results (TerrPlant v 1.2.2) ... ........... ... 1 72 Appendix F. Ecological Effects Data........................... ................... ............................... 1 75 Appendix G . Flutriafol Ecological Effects Bibliography............... .............. ........................ 203 App endix H . Flutriafol Environmental Fate Bibliography ..................... .................... ........................ 2 0 8 Appendix I . Direct Effects Endangered Species Analysis for Apples....... ....... ................................. Compact Disc Ap pendix J. Ind irect Effects Endangered Species Analysis for Apples ...... ............ ................... Compact Disc Appendix K . D irect Effects Endangered Species Analysis for Soybeans...... .... ........... .................. Compact Disc Appendix L. Indirect Effects Enda ngered Species Analysis for Soybeans........ ........ ........................ Compact Disc Appendix M. PRZM Input File for Runoff, Erosion, Leaching Assessment ...... ........ ........................ 2 14 FI GURES AND GRAPHS Figure 1. Flutriafol .................. ...................... ........................... ....... ... ......... ........ 19 Figure 2. Flutriafol Environmental Risk Conceptual Model .................. ....... ............... ... 26 Figure 3 . Time Series of Flutriafol Concentrations in Surface Soil (10 cm depth) for the MS Soybean Scenario.......................................... .................. ....... ............... ... 34 Graph IV- 1. Number of Applications Required to Exceed the LOC of 1 for Adverse Effects of Grow th and Reproduction to Birds ............................. ............... .................................... 925

I. EXECUTIVE SUMMARY A. Nature of the C hemical Stressor The new active ingredient, flutriafol ((RS)
- 2,4'
- difluoro
- a - (1H
- 1,2,4
- triazol
- 1
- yl methyl)benzhydryl alcohol); CAS Reg No. 4787
- LL) is a triazole derivative used as a s ys temic fungicide. Flutriafol belongs to a group of demethylation inhibitors (DMI fungicides ). While testing for this chiral compound was conducted on the racemic mixture, no data are available for either of the resolved isomers, and onl y one of the minor degradate s forming in the laboratory studies retained a chiral center . The mode of action for this conazole fungicide, flutriafol, is as a sterol biosy

nthesis inhibitor ( SBI ) that inhibits microsomal sterol demethylation in membranes
. Common with all other DMIfungicides, flutriafol has a nitrogen atom that attaches to th e center of an iron group within the cy tochrome, which prevents or blocks the formation of ergosterol during demethylation
. F or a conozol e fungicide, the triazol moiety of toxicological concern is expected as a degradation product. There were no major de gradation products reported in any studies submitted in support of this registration. Flutriafol degraded with half
- lives greater than a year in most environmental compartments
. There is one proposed product for flutriafol: TOPGUARD TM Fungicide ( EPA Re g. No. 67760
- T L) , also known as Flutriafol 125 g/LSC
. It is used to control scab , powdery mildew , and quince and cedar apple rust on apples and soy bean rust , fro geye leaf spot, cercospora blight and leaf spot, brown spot, powdery mildew on s oy

beans. TOPGUARD TM Fungicide (1 1.8 % ai ) is a soluble concentrate containing 1.04 pound per gallon of the active ingredient flutriafol that can be diluted with water
. It is worthwhile to note that a comparison of the available formulated product (TOPGUARD fungicide) and flutriafol technical toxicity data shows that the formulated product (TOPGUARD fungicide) , when values are expressed in terms of the active ingredient, is approximately

30 to 50
- fold more toxic than the active ingredient in an aquatic environment
. B. Po tential Risk to Non - target Animals and Plants The Agency ’s Levels of Concern (LOCs) for potential risk to animals and plants is determined when a RQ exceeds one or more of the following risk presumption categories. When there is a LOC exceedance, it indic ate s that a pesticide used as directed has the potential to cause adverse effects on non
- target wildlife. LOCs currently address the following risk presumption categories: (1) acute risk

– when a RQ is equal to or greater than the LOC of 0.5 to animals , ( 2) acute restricted use

– when a RQ is equal to or greater than the LOC of 0.2 and 0.1 for terrestrial and aquatic animals, respectivel y , (3) acute endangered species

– when a RQ is equal to or greater than the LOC of 0.1 and 0.05 for terrestrial and aquatic animals, respectivel y , (4) chronic risk

– when a RQ is equal to or greater than the LOC of 1.0 to animals , and (5) non listed and listed plant risk
- when a RQ is equal to or greater than the LOC of 1.0 to plants
. Table I - 1 presents the RQs for terre strial and aquatic animals and plants exposed to flutriafol and its formulated product ( Flutriafol 125 g/L)
.6

Table I - 1. Summary of Risk Quotient Calculations for Flutriafol and Flutriafol 125 g/L SC Exposures to Terrestrial and Aquatic Animals and Plants . * Species Flutriafol RQs Flutriafol 125 g/L SC RQs Exposure Model Used Aquatic Animals and Plants Freshwater Fish Ac ute RQs: <0.01 Chronic RQs: <0.1 Ac ute RQs: <0.01

GENEEC2 Estuarine/marine Fish Ac ute RQs: <0.01 Chronic RQs: <0.1 Ac ute RQs: <0.01 F reshwater Invertebrates Ac ute RQs: <0.01 Chronic RQs: <0.1 Ac ute RQs: < 0.01 Estuarine/marine Invertebrates Ac ute RQs: <0.01 Chronic RQs: <0.1 Ac ute RQs: < 0.01 Aquatic Vascular Plants Non
- listed RQs: <0.1 Listed RQs: <0.1

– 0.6 Aquatic Non
- Vascular Pl ants Non
- listed RQs: <0.1 Listed RQs: <0.1
-- 0.1 Terrestrial Anim als and Plants Birds Ac ute RQs: <0.01

– 0. 25 Chronic RQs: <0.1

– 2. 2 -- T
- REX Mammals Ac ute RQs: <0.01

– 0. 4 Chronic RQs: <0.1

– 1.8 Ac ute RQs: <0.01 Terrestrial Monocots Non
- listed RQ s: <0.1 Listed RQs: <0.1 TERRPLANT Terrestrial Dicots Non
- listed RQs: <0.1 Listed RQs: <0.1 * Values in bold are LOC exceedances Tables I - 2 and I - 3 provide a summary of the environmental risk conclusions of the active ingredient (AI ) to aquatic and terrestrial animals and plants , respectivel y, from proposed use patterns for apples and soy beans
. The environmental risk conclusions for the AI are based on the most sensitive toxicity

endpoints and maximum use scenarios. Details of the environmental risk co nclusions for the AI can be found in the Risk Description section ( Section IV.B )
. Table I - 2 . Flutriafol (AI) : Summary of Environmental Risk Conclusions for Aquatic Animals & Plants Assessment Endpoint Use Patterns with LOC Exceedances Summarized Risk C haracterization Ac ute and Chronic Risk to Freshwater Fish ( and Aquatic
-phase Amphibians ) and Invertebrates. None No acute or chronic LOC exceedances for freshwater fish , aquatic
-phase amphibian , and invertebrate species exposed to the AI
.
Ac ute and Chronic Risk to Estuarine/Marine Fish and Invertebrates None No acute LOC exceedances for estuarine/marine fish and invertebrate species exposed to the AI
. D ue to lack of chronic to xicity data , the risks are uncertain
. H owever, there are no chronic LOC exce edances using estimated NOAECs
. Risk to Aquatic Vascular and Non
- vascular Plants None There are no LOC exceedances for non
- listed and listed aquatic plants (both vascular and nonvascular) exposed to the AI
.7

Table I - 3 . Flutriafol (AI ) : Summary of Envi ronmental Risk Conclusions for Terrestrial Animals and Plants Risk Conclusion Use Patterns with LOC Exceedances Summarized Risk Characterization

Ac ute Risk to Birds (including terrestrial
phase amphibians and reptiles) Apple : T wo or mo re applications, the acute endangered LOC is exceeded for small
- sized birds. At 4 or mo re applications, the LOC is exceeded for medium
- sized birds. Soy bean: No LOC exceedance for one or two applications. At the maximum number of applications (3) with 14
- day intervals, the acute endangered LOC is exceeded. If the reapplication interval is increased to 21 days from 14 days, there are no acute LOC exceedances. Apple: The a cute restricted use and acute endangered LOCs are exceeded for small
- and medium
- sized birds foraging on the assessed food items except fruits, pods, large insects, and seeds
. There are no acute LOC exceedances for large
- sized birds (1000g). Sma ll
- sized (20g) birds and medium
- sized (100g) birds (including terrestrial
-phase amphibians and reptiles) foraging in or near an apple site with two applications or more wo uld be at risk for adverse effects o n survival as a result of exposure to the AI
. Soy bean (3 times @ 0.06 lb ai/A with 14
- day interval) : The a cute endangered LOC is exceeded for small
- sized birds feeding on short grass. No acute LOC exceedances for 100 g and 1000 g birds , reptiles, and terrestrial
-phase amphibians exposed to flutriafol technical. S mall
- sized birds feeding in or near a soy bean field would be at risk for adverse effects on survival as a result of exposure to the AI
. Soy bean (3 times @ 0.06 lb ai/A with 21
- day interval) : There are no acute LOC exceedances for any birds of any weight classes exposed to the AI.

Chronic Risk to Birds (including terrestrial
phase amphibians and reptiles) A pple: T wo or more applications, the acute endangered LOC is exceeded for birds feeding on short grass. At 3 or more applications, the LOC is exceeded for birds feeding on broadleaf plants and small insects. It requires 4 or more applications for potential risk to birds feeding on tall grass. Apple: T he c hronic risk LOC is exceeded for birds foraging short grass , tall grass, broadleaf plants and small insects following flutriafol application s to apples. B irds of all weight classes (including terrestrial
-pha se amphibians and reptiles) foraging food items with flutriafol residues in or near an apple site with two application s or more would be at risk for adverse effects o n growth and reproduction as a result of exposure to the AI
. Soy bean : No chronic LOC exce edances for birds of all weight classes, including terrestrial
-phase amphibians and reptiles exposed to the AI
.

Ac ute Risk to Mammals Apple : One or more application(s), the acute endangered LOC is exceeded for small
- and medium
- sized mammals, two or more applications to exceed the LOC for large
- sized mammals
. Soy bean : No exceedance for one application. At 2 or more applications, the acute endangered LOC is exceeded Apple: T he acute risk, acute restricted use, and acute endangered LOCs are exceeded for all weight classes (15g, 35g, 1000g) of mammals foraging on the assessed food items except fruits, pods, large insects, and seeds. The 15g, 35g, 1000g mammals foraging in or near an apple site would be at risk for adverse effects on survival as a result of exposure to AI
. Soy bean (3 times @ 0.06 lb ai/A with either a 14
- day or 21
- day interval): T he acute restricted and acute endangered LOCs are exceeded for 15 g and 35 g mammals feeding on short grass. There are no acute LOC exceedances for 1000 g mammals or for 15 and8

Table I - 3 . Flutriafol (AI ) : Summary of Envi ronmental Risk Conclusions for Terrestrial Animals and Plants Risk Conclusion Use Patterns with LOC Exceedances Summarized Risk Characterization for some mammals. 35 g mammals that feed on tall grass, broadleaf plants, insects, and seeds. The 15g and 35g mammals foraging on short grass in or near a soybean field wo uld be at risk for adverse effects on survival as a result of exposur e to the AI
.

Chronic Risk to Mammals Apple : No exceedance for two applications. At 3 or more applications, the acute endangered LOC is exceeded for small and medium size d mammals. Apple: The chronic risk LOC is exceeded for 15g mammals foraging short grass, tall grass, broadleaf plants and small insects, for 35g mammals foraging short grass, broadleaf plants, and small insects, and 1000g mammals foraging short grass following flutriafol applications to apples. All weight classes of mammals feeding on s hort grass and some feeding on tall grass, broadleaf plants and small insects in or near an apple field would be at risk for adverse effects on reproduction and grow

th as a result of exposure to the AI
. Soy bean: No chronic LOC exceedances for mammals of a ll weight classes exposed to the AI.
Risk to Beneficial Insects None Available honeybee toxicity data indicate that flutriafol technical is practically non
- toxic to honeybees from direct treatment; therefore, precautionary label language to protect bees f rom flutriafol exposures is not required. Risk to Terrestrial Plants None No listed or non
- listed LOC exceedances for terrestrial mo nocots and dicots exposed to the AI via runoff and spray drift following one application to apple or soy bean
. The formul ated product of flutriafol (Flutriafol 125 g/L SC) has been shown to be more toxic to aquatic animals than the technical grade active ingredient
. The risk s to the formulated product must be assessed rather than just those to the active ingredient. For th is assessment with the formulated product as a whole , the product toxicity values were compared to AgDRIFT exposure concentrations for any potential risks to aquatic animals
. AgDRIFT exposure concentrations for the formulation are derived b y assuming that the agriculturall y applied formulation immediately reach es adjacent non
- target sites through spray drift. The model, AgDRIFT , onl y estimat e s spray drift (or ‘acute’ ) exposure concentration s ; chronic exposure estimation s (from runoff or spray drift) are not possible for the formulated product, Flutriafol 125 g/L SC , and the risks from chronic exposure (from runoff or spray drift) to aquatic animals based on the product toxicity values (mg form/L) are therefore not included in this assessment
. Tables I - 4 an d I - 5 provide a summary of the environmental risk conclusions of the formulated product as a whole (based on the combination of the AI and inerts , the “product toxicity values” ) to terrestrial and aquatic animals and plants, respectively
. Details of the environmental risk9

conclusions for the formulation can be found in the Risk Description section ( Section IV.B )
. Table I - 4 . Flutriafol Formulated Product: Summary of Environmental Risk Conclusions for Terrestrial Animals & Plants Assessment Endpoint Use P atterns with LOC Exceedances Summarized Risk Characterization
Ac ute Risk s to Mammals None For the formulated product, there are no acute LOC exceedances for mammals exposed to the formulated product following one application to soybean or apple
. Risk to Terrestrial Plants None No listed or non
- listed LOC exceedances for terrestrial mo nocots and dicots exposed to the formulated product via spray drift following one application to apple or soy bean
. Table I - 5 . Flutriafol Formulated Product: Summary of E nvironmental Risk Conclusions for Aquatic Animals & Plants Assessment Endpoint Use Patterns with LOC Exceedances Summarized Risk Characterization
Ac ute Risks to Freshwater and Estuarine/marine Fish None No acute LOC exceedances for freshwater and estuarine/marine fish exposed to the formulat ed product via spray drift following one application of flutriafol 125 g/L SC to soybean and apple. Ac ute Risk to Freshwater Invertebrates None No acute LOC exceedances for freshwater invertebrates exposed to the f

ormulated product via spray drift following one application of flutriafol 125 g/L SC to soybean and apple
. Ac ute Risk to Estuarine/marine Invertebrates None T here are no acute LOC exceedances for estuarine/marine invertebrates adjacent to apple and soybe an sites exposed to the product via spray drift following one application. Risk to Aquatic Vascular and Non
- vascular Plants None No listed or non
- listed LOC exceedances for aquatic plants, both vascular and nonvascular, exposed to the formulated product via spray drift following one application. C. Exposure Characterization Flutriafol is a fungicide that is expected to be persistent and moderatel y mobile in the environment . Because leaching, runoff, erosion, and accumulation in soil are possible proce sses controlling the environmental fate of flutriafol, PRZM modeling was conducted to assess the contribution of each process in controlling the environmental fate of flutriafol under field conditions. PRZM modeling predicted that the dominant route of dis sipation for flutriafol is leaching below the root zone ; the contributions from runoff and erosion were much less. Results from n on - guideline field dissipation studies showed that following multiple applications over a number of ye ars, flutriafol residu es were found in the soil to the maximum depth sampled.10

However, no field data quantifying the maximum depth of leaching under actual use conditions have been provided. As a result , the combination of modeling predictions and field observations of leach ing would indicate a potential for flutriafol to contaminate ground water. Al though PRZM modeling results did not indicate that accumulation in soil was the controlling dissipation process, modeled flutriafol concentrations in soil remained steady at an elevated level for the duration of the simulation. This is consistent with both the laboratory data (half

- li ves of more than one ye ar in aerobic soil ) and data from the same terrestrial field dissipation studies mentioned above which showed flutriafol ac cumulation with repeated applications
. Although no major degradation products of flutriafol have been identified in the fate studies, 1,2,4
- triazole has been identified as a minor degradate in the submitted fate studies, and has been determined to be a human health concern by the OPP Health Effects Division (HED)
. 1,2,4
- Triazole is a common degradate of all conazole pesticides and its fate properties and toxicity will be addressed b y the Agency 1 in a separate assessment at a later date and are not includ ed in this assessment. E stimated environmental concentrations (EECs) in water are estimated using the Tier I model GENEEC2 (Version 2.0; August 1, 2001 ), which simulates exposure in a standard pond of the active ingredient to aquati c species resulting from deposition, runoff, and spray drift . Based on the labeled information to control apple scab on apples at a maximum application rate of 0.11 lb a.i./A, applied 4 times at 7 day intervals, the maximum model predicted peak, 21
- day , and 60
- day GENEEC EECs are 0.02 1 mg a.i./L, 0.0 2 1 mg a.i./L, and 0.0 2 1 mga.i./L , respectivel y. Because the RQs for listed aquatic vascular plants exceeded the level of concern of 1.0 with the generic Tier I EECs, the T ier II model PRZM (Version 3.12.2) /EXAM S (Version 2.98.04) was used to estimate the surface water EECs from different geographical locations. To control apple scab on North Carolina apples, the maximum model predicted peak, 21
- day , and 60
- day PRZM/EXAMs EECs are 0.01 mg a.i./L , 0.0091 mg a. i./L, and 0.008 mg a.i./L , respectivel y. Terrestrial exposure to birds and mammals are considered using the T
- REX (Ver.1.3.1) model to estimate residues on food ty pes as the result of flutriafol application. Based on the maximum labeled application rate for apples (0.11 lbs ai/A), applied 4 times at 7
- day intervals was used to predicted the highest dietary
- based residue for the assessed food items that could be foraged b y the animals. The EECs for short grass, tall grass, broadleaf forage/small insects, and seeds/large insects are 86.8 mgai/kg, 39.8 mg ai/kg, 4 8 .8 mgai/kg, and 5.4 mgai/kg, respectivel y. EECs based on maximum application rates for non
- target terrestrial plants are estimated using the TerrPlant (Ver 1.3.1) model in this risk assessment. Exposure estimates from off
- site spray

drift to areas adjacent to treated areas were generated using the AgDRIFT model (Ver 2. 0.1). Quantitative exposure modeling for formulations is based on the expectation that the varying phy sical
- chemical properties of individual components will control the environmental fate of the formulated product. Thus, it is not possible to calculate acute or chronic exposure estimates to aquatic animals and plants via runoff or chronic exposure estimates to any

of these taxa vi a spray drift since it is unlikely that the components of the
1 http://www.epa.go v/opprd001/factsheets/tetraHHRA.pdf11

formulation will drift or runoff to these non
- target areas together as an unit after repeated applications
. D. Effects Characterization Aquatic Effects Available acute toxicity

data for aquatic animals (freshwater, estuarine and marine) indicate th e AI is no more than slightly toxic to fish and is slightly toxic to invertebrates
. Chronic effects for the AI are reduced post
- hatch survival of freshwater fish at 9.5 mg ai/L ; the NOAEC is 4.8 mg ai/L . Significant effects o n reproduction and growth in freshwater invertebrates were observed at a range of NOAEC value s of 0.31 mg ai/L to 1.0 mg ai/L for the active ingredient
. C hronic toxicity

of the AI to estuarine/marine animals is not available . A cute to chronic ratio (ACR) values were derived from different fish or invertebrate species to estimate the estuarine/marine fish and invertebrate NOAECs
. The estimated NOAECs for estuarine/marine fish and invertebrates exposed to the AIare >11 mg ai/L and 0.013 mg ai/L, respectivel y. Comparison of toxicity

studies using the AI and the formulation blank group in its formulated product studies suggests the toxicity of one or more inert (inactive) ingredient s is considerabl y higher in aquatic environm ents than the toxicity of the active ingredient. The L C 50 and EC 50 for freshwater fish and invertebrates exposed to the formulated product (Flutriafol 125 g/L SC) are 7.6 mg form/L and 6.8 mg form/L , respectivel y. The formulat ed product caused reproducti ve effects in freshwater invertebrates as low as 0.33 mg form/L; the NOAEC is 0.1 mg form/L. The acute toxicity

of the formulated product (Flutriafol 125 g/L SC) to estuarine/marine animals was not available . Therefore, acute to acute ratio (AAR) values w ere used to estimate the estuarine/marine fish and invertebrate acute toxicity values for the formulated product. The estimated LC 50 and EC 50 for estuarine/marine fish and invertebrates exposed to the formulat ed product are > 16.5 mg form/Land 2.5 mg form/L, respectivel y. Exposure to the formulated product resulted in growth inhibition of cell density in marine diatom s (aquatic non
- vascular plant s ), with the lowest EC 50 of 0.46 mg ai/L (NOAEC = 0.1 mg ai/L). For duckweed , the EC 50 for the formulated produ ct is 0.78 mg ai/L (NOAEC <0.13 mg ai/L ; EC 05 = 0.018 mg ai/L). Terrestrial Effects Available acute toxicity

data indicate that the AI is slightly toxic to practically nontoxic to upland game birds and waterfowl via o ral gavage and subacute dietary route s. No acute oral toxicity data are available for a passerine bird tested with the AI. Available toxicity data with upland game bird and waterfowl suggest flutriafol could be toxic to passerine birds
. C hronic studies for the AI show reproductive effects of reduced hatchability in upland game birds and waterfowl at 95 and 97.5 mg ai/kg diet, respectively . The avian NOAEC s are <95 and 39.2 mg ai/kg diet , respectivel y .12

Acute toxicity

data indicate the AI is moderatel y t o slightly toxic to mammals. Results o f the 2
- generation study with the A I indicate reproductive effects with a reduction in parent body weight gains, effects on the liver, litter size and fertility index observed at 1000 mg ai/kg diet (males 88.7 mg ai/kg bw/day ; females 103 mg ai/kg bw/day) with a corresponding NOAEC of 240 mg ai/kg diet (males 20.6 mg ai/kg bw/day ; females 21.9 mg ai/kg bw/day). Available Flutriafol 125 g/L SC toxicity data indicate the product is not toxic to mammals ( LD 50 >2000 mg form/kg
- bw)
. Acute contact honey

bee studies indicate that flutriafol and its formulat ed product s are practically nontoxic to honey

bees
. Terrestrial plant toxicity

studies with monocots and dicots indicate the formulat ed product of flutriafol did not cause 25% inhibition at the limit dose o f 0.12 lbs ai/A
. E. Endangered (Listed) Species As shown in Table I - 6 , this ecological risk assessment for use of flutriafol on soy bean s and apple s indicates direct effects LOCs exceedances for birds, terrestrial
- phase amphibians, reptiles, and mammals . Therefore, there is potential for indirect effects to all listed terrestrial animal and plant taxa that depend on those animals as pollinators or seed dispersers, mammal or reptile burrows for habitat, feeding, or cover requirements, and for survival, growth, or reproduction. The listed animal and plant species that reside in areas where flutriafol may be used are summarized in a

ppendices J and K for a

pples and appendices L and M for s oy beans
. Table I - 6 . Listed Taxonomic Groups Potentially at Risk for Direct or Indirect Effects as a Result of Flutriafol Applications (Applications are for Terrestrial Outdoor Uses where Apples and Soybeans are grown Nationwide). Listed Taxon Direct Effects Uses of Direct Effects

Concern Indirect

Effects Uses of Indire ct Effects

Concern Terrestrial and Semi
Aquatic Plants

– mo nocots No None Yes 3 ,4 Apple and Soybean Terrestrial and Semi
Aquatic Plants
-- dicots No None Yes 3 ,4 Apple and Soybean Terrestrial Invertebrates No None Yes 3,4 Apple and Soybean Birds and Rep tiles 1 Yes Apple and Soybean 6 Yes 3,4 Apple and Soybean Terrestrial
-phase Amphibians 1 Yes Apple and Soybean 6 Yes 3,4 Apple and Soybean Mammals Yes Apple and Soybean 5 Yes 3,4 Apple and Soybean Aquatic Vascular Plants No Apple Yes 3,4 Apple and Soybean Fres hwater Fish and Aquatic
-phase Amphibians 2 No None None None Freshwater Invertebrates No None None None Estuarine/marine Fish No None None None Estuarine/marine No None None None13

Invertebrates Aquatic Nonvascular Plants No None Yes 3,4 Apple and Soyb ean 1 Birds are used as surrogate species for terrestrial
-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, terrestrial
-phase amphibians and reptilian species are considered equivalent. 2 Fish are used as a surrogate for aquatic phase amphibians; therefore, potential direct and indirect effects to endangered fish and aquatic
-phase amphibian species are considered equivalent. 3 Potential indirect effects on a taxon attributable to direct effects on birds, terrestrial
-phase amphibians and reptiles. 4 Potential indirect effects on a taxon attributable to direct effects on mammals. 5 Both soybean uses to control soybean rust and leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew
. 6 For contro l of leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew growing on soybeans only. The baseline risk assessment for endangered species indicates that the active ingredient, flutriafol, exceed s the LOCs for the specified use scenario s tabulated in Table I - 7 for apples and Table I - 8 for soy

beans for the following taxonomic groups: Table I - 7 . Flutriafol Endangered Species LOC Exceedances for Apple Use Levels of Concern Taxa Acute Endangered Species Chronic

Risk Listed Plants Birds (including Reptiles and Terrestrial
-phase Amphibians) 20 g Yes Yes 100 g Yes 1000 g No Mammals 15 g Yes Yes 35 g Yes Yes 1000 g Yes Yes Freshwater (including Aquatic
phase Amphibians) and Estuarine/marine Fish No No Freshwater and Estuarine/marine Invertebrates No No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No14

Table I - 8 . Flutriafol Endangered Species LOC Exceedances for Soybean Use Levels of Concern Taxa Acute Endangered Species Chronic

Risk Listed Plants Birds (including Reptiles and Terrestrial
-phase Amphibians) 20 g Yes 1 No 100 g No 1000 g No Mammals 15 g Yes 2 No 35 g Yes 2 No 1000 g No No Freshwater (including Aquatic
phase Am

phibians) and Estuarine/marine Fish No No Freshwater and Estuarine/marine Invertebrates No No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No 1 Based on 3 applications @ 0.06 lb ai/A with a 14
- day interval. 2 Based on 3 applications @ 0.06 lb ai/A with a 14 day interval and 3 applications @ 0.06 lb ai/A with a 21
- day interval. The baseline risk assessment for endangered species indicates that the formulat ed product of flutriaf ol, Flutriafol 125 g/L SC, exceed s the LOCs for the specified use scenario tabulated below ( Table I - 9 for apples and soy beans) for the following taxonomic groups: Table I - 9 . Flutriafol 125 g/L SC Endangered Species LOC Exceedances for Apple and Soybean Us es 1 Levels of Concern Taxa Acute Endangered Species Listed Plants Birds (including Reptiles and Terrestrial
-phase Amphibians) 20 g No data 100 g 1000 g Mammals 15 g No 35 g No 1000 g No Freshwater (including Aquatic
phase Amphibians ) and Estuarine/marine Fish No Freshwater Invertebrates No Estuarine/marine Invertebrates No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No 1 Based on the formulated product as a whole F. Uncertainties and Data Gaps 1. Environmental Fate and Exposure Assessment15

 Several non
- guideline terrestrial field dissipation studies with applications over multiple ye ars showed that flutriafol residues were found at all sampling depths throughout the duration of the studies. However, no field data quantifying the depth of leaching under actual use conditions have been provided. As a result , the combination of leaching and persistence would indicate a potential for ground water contamination.

 No major degradates (10% or more of applied test material residues) of flutriafol were identified in any

submitted studies. The persistence of the parent compound suggests that major degradates might have formed if the multiple year terrestri al field dissipation studies had tested for degradation products (MRID s 47115502, 47090431). The minor triazol degradate of known toxicity (1,2,4
- triazole) , which has been identified in laboratory soil photoly sis and anaerobic aquatic metabolism studies i s a human health concern b y the OPP Health Effects Division (HED) 2 , has not been considered in this ecological assessment by the OPP Environmental Fate and Effects Division (EFED) , but will be assessed at a later dat e in an OPP cumulative assessment.

 Several non
- guideline terrestrial field dissipation studies with applications over multiple ye ars indicate that flutriafol residues will remain undegraded, allowing residues to carry
- over from year to year under actual use conditions. As a result, it is dif ficult to estimate the maximum amount of flutriafol residues which might accumulate from successive annual applications.

 Since the varying phy sical
- chemical properties of individual components of the formulated product ( Flutriafol 125 g/L SC ) will result in progressively different formulation constituents in the environmental media over time and there are no data about the environmental fate properties of the product , GENEEC2 and PRZM/EXAMs are unable to generate exposure concentrations of the product for comparison with the available toxicity data on the product
. For this assessment , acute risk s of the formulated product (Flutriafol 125 g/L SC) to aquatic animals was compared with the toxicity value of the formulated product as a whole to the AgDRIFT expo sure concentrations
.
 Since the AgDRIFT EECs are used as spray drift (or ‘ acute ’) exposure endpoints in the assessment, no chronic exposure endpoints (from spray drift or runoff) are available for the formulated product. Thus, i t is not possible to evaluat e the chronic exposure of the formulated product (active and inert ingredients) to animals and plants
.
 Flutriafol residues have been detected in surface samples taken from the Svalbard archipelago ice cap in arctic Norway . This seems to contradict both field volatility and Henry ’s Law Constant data , which would predict a low likelihood of long
- distance transpor t . In an article appearing in Environmental Science and Technology 3 , it has been suggested that atmospheric persistence combines with long term atmospheric transport due to fast moving

2 http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf 3 Hermanson, Mark H, et. al, Current
- Use and Legacy Pesticide History in the Austfonna Ice Cap, Svalbard, Norway , Environmental Science and Technology, 2005 , vol. 39 , pp. 8163

– 8169.16

summer air masses. EFED has no means of quantifying this atmospheric transport at this time. 2. Ecological Effects Additional uncertainty results from the lack of ecological effects information and/or data as fol lows :

 Toxicity

d ata for freshwater fish and invertebrates, mammals, and terrestrial and aquatic plants with the formulated product , Flutriafol 125 g/L SC, are available. A comparison of the available formulated product (TOPGUARD fungicide) and technical grade toxicity data shows the formulated product, when results are expressed in terms of the active ingredient, is approximately

30 to 50
- fold more toxic than technical grade flutriafol in an aquatic environment
. Formulation blank data suggest the greater toxicity of the formulated product is not due to sy

nergistic effects of the combination of the active ingredient and inerts, but is due to the toxicity

of one or more of the inert ingredients. A change in the inert ingredients for TOPGUARD could mitigate the toxicity to aquatic organisms and plants.

 There are no avian acute oral toxicity data available for passerine birds. The survival of passerine birds exposed to the active ingredient (AI) is uncertain. A risk assessment for acute exposure to passerine birds is needed based on flutriafol’s agricultural uses on soy beans and apples. In addition, the AI is classified as slightl y t oxic to upland game birds (partridge). Since the 40 CFR 158 guidelines were updated, the Agency has worked to finalize its updat e to the data requirements in 40 CFR 158, which were promulgated in October 2007. An avian acute oral study

with a passerine bird is required to support the terrestrial outdoor use patterns that are expected to reach this environment . Given the acute LOC e xceedance s for non - passerine birds in this baseline risk assessment, it is possible that passerine birds would be at risk from flutriafol exposures. The data will be utilized to determine whether the Agency ’s current measures are effective for protecting p asserine birds.

 There are no chronic toxicity data available for estuarine/marine fish and inverteb rates; thus, the potential chronic risk of flutriafol is quantitatively estimated using ACR (acute to chronic ratio) values
. Until chronic toxicity data are available , the potential risks to estuarine/marine animals are uncertain
. Given that there are no chronic L OC exceedances using estimated toxicity values of the active ingredient (AI ) combined with the indication of minimal acute and chronic risk s for f

reshwater animals, chronic risk to estuarine/marine animals exposed to the AI is expected to be minimal. However, if data are submitted and are lower than the estimated NOAECs, the potential risk to the reproduction and growth of estuarine/marine fish and invertebrates may be underestimated.

 There are no toxicity

data available for estuarine/marine fish and invertebrates with the formulat ed product, Flutriafol 125 g/L SC , to evaluate the toxicity of the active ingredient (AI) in its formulated product ; thus, the potential acute risk of the product to these taxa is quantitatively

estimated using AAR (acute to acute ratio) values. Until these toxicity data are available, the potential risks to estuarine/marine fish and invertebrates are uncertain.17

Submission of estuarine/marine toxicity studies with Flutriafol 125 g/L SC would reduce the uncertainty associated with using an AAR
.
 Technical grade active ingredient or formulation t oxicity data on sediment dwelling organisms have not been submitted. Based on th e persistence of flutriafol in water and the toxicity of flutriafol to other aquatic organisms, toxicity data on sediment dwelling organisms would greatl y strength en this assessment.

3. Endangered Species

 With L OC exceedances for direct effects to b irds, reptiles, terrestrial
- phase amphibians, and mammals based on flutriafol use in agricultural areas where so ybeans and apples are grown, LOCATES was run for all listed birds, reptiles, terrestrial
- phase amphibians, and mammals in the database to determ ine the potential for co
- occurrence of listed species locations with areas of potential fungicide use. Consequentl y, based on the information available at this step in the assessment process, it is presumed that all listed birds, reptiles, terrestrial
- pha se amphibians, and mammals are potentiall y affected directly and indirectly to all th o se taxa that are dependant on these taxa from the flutriafol uses in agricultural areas, should exposure actuall y occur. Additional analysis of listed species locations, refinement of the action area associated with flutriafol regulatory decisions, and the biology of the potentially

affected species would be needed before an effects determination can be made for any of the co
located species identified by this assessment.18

I I . PROBLEM FORMULATION The purpose of this risk assessment is to assess ecological risks associated with the new active ingredient , flutriafol ( (RS)
- 2,4'
- difluoro
- a - (1H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol) , and its formulated produc t, Flutriafol 125 g/L SC , when use d on apples and soy beans
. As such, this document articulates the purpose and objectives of the risk assessment, evaluates the nature of the problem, and provides a plan for anal yz ing the data and characterizing the risk(s) (EPA, 1998). A. Nature of Regulatory Action Under the authority

of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Cheminova, Inc. is seeking the registration of the new active ingredient, flutriafol , for use as a sy stemic fungicide on app les and soy bean s . B. Stressor Source and Distribution 1. Nature of the Chemical Stressor The new active ingredient, flutriafol ( (RS)
- 2,4'
- difluoro
- a - (1H
- 1,2,4
- triazol
- 1
- yl methyl)benzhydryl alcohol ), is a triazole derivative used as a s ys temic conazole f ungicide (Figure 1)
. Flutriafol belongs to a group of demethylation inhibitors (DMI fungicides). The mode of action for flutriafol is as a sterol biosy nthesis inhibitor (SBI) that inhibits microsomal sterol demethyl ation in membranes. Common with all oth er DMI fungicides, flutriafol has a nitrogen atom that attaches to the center of an iron group within the cy tochrome, which prevents or blocks the formation of ergosterol during demethylation. F lutriafol is a member of the triazole class of fungicides. Other members of this class are registered for use in the United States. Flutriafol is registered in other countries as well. A summary

of selected phy sical, chemical, and environmental fate properties of flutriafol is presented in Table II - 1
. Abiotic degradation through hydrol ys is and aqueous photolysis are very slow for flutriafol. In soil, flutriafol is persistent, with a half
- life value of more than one ye ar . F lutriafol degraded more rapidly under anaerobic aquatic environments with a total half
- life value of about 6 weeks
. Freundlich soil:water partitioning coefficients for flutriafol ranged from 3.2 to 9.8 L/kg. Organic carbon partitioning coefficients ranged from 140 to 420 L/kg
- OC. These data suggest flutriaf

o l is moderatel y mobile in terrestrial and aquatic environments. Bioaccumulation is not expected due to the low octanol
- water partitioning coefficient ( log Kow value of 2.3). Field dissipation studies show that flutriafol is persistent and mobile. Additionally, there was accumulation of flutriafol in soil in long field dissipation studies. The potential for mobility and high persistence of flutriafol suggest that leaching is the major route of dissipation. Although the vapor pressure and Henry ’s Constant of flutriafol are low, flutriafol residues have been detected in surface samples taken from the Svalbard archipelago ice cap in arctic Norway4 indicating a potential for long term atm ospheric transport. It has been

4 Hermanson, Mark H, et. al, Current
- Use and Legacy Pesticide History in the Austfonna Ice Cap, Svalbard, Norway , Environmental Science and Technology, 2005 , vol. 39, pp. 8163

– 8169.19

theorized that transport results from a combination of apparent atmospheric persistence and fast moving summer air masses. EFED has no means of quantifying this atmospheric transport at this time, and, as a result, this remains an uncertainty in this assessment. Due to the slow degradation of flutriafol, major degradates were not detected in either laboratory or field studies. Minor degradates of flutriafol, which were onl y reported in two studies, a soil photoly sis study

and an anaerobic aquatic metabolism study include 1 ,2,4
- triazole , triazole acetic acid , triazole alanine , 2,4’
- difluorobenzophenone , and c arbon dioxide (CO 2 ). With the exception of 1,2,4
- triazole, none of the degradates above were considered a human health concern b y the OPP Health Effects Division (HED). 1,2,4
- Triazole was a minor degradate in the submitte d studies, but is a common degradate to other conazole fungicides. 1 ,2,4
- Triazole has been determined to be a human health concern. As a result, its fate properties and toxicity will be addressed b y the Agency in a separate assessment. The chemical structure of flutriafol is provided in Figure 1
. Figure 1. Chemical Structures (a) Flutriafol 

### NN N C

H 2 

### O H F F 

# N N H N (b) 1,2,4 - Triazol e

Table II - 1 Physical, Chemical and Environmental Fate Properties of Flutriafol Physical and Chemical Properties Chemical Name (common) Flutriafol Chemical Name (CAS) α - (2
- Fluorophenyl)
- α - (4
- fluorophenyl)
- 1H
- 1,2,4
- triazole
- 1
- ethanol Chemical Abstract Number (CAS Number) 76674
- 21
- 0 Chemical Class conazole Molecular Weight (g/mol) 301.3 Aqueous Solubility (20  C) 130 mg/L pKa 2.3 A Vapor Pressure 4 x 10 - 7 Pa Henry’s Law Constant ( 20  C) 1.3 x 10 - 11 atm x m 3 x mol - 1 Octanol/water Partition Coefficient (log Kow at pH7) 2.29 B20

Table II - 1 Physical, Chemical and Environmental Fate Properties of Flutriafol Physical and Chemical Properties Environmental Fate Properties Hydroly sis Half

- life (pH 5, 7) t 1/2 = stable Aqueous Photolysis Half
- life t 1/2 = stable Soil Photolysis Half

- life t 1/2 = 72.2 days (extrapolated) Aerobic Soil Metabolism Half
- lives (total system) t 1/2 = 120, 161, 257, 84, 98, 315, 3466, 347, and 239 weeks Anaerobic Metabolism Half
- lives (total system) t 1/2 = < 1 day in water t 1/2 = > 365 days in total system Aerobic Aquatic Metabolism Half
- lives t 1/2 = 42.6 days in water

t 1/2 = > 100 days in total system Soil
- Water Partitioning Coefficients (Koc ) 498, 205, 379, 230, 340, 428, 140 Bio accumulation in Fish Maximum BCF values are 6.8 for whole fish (day 3), 4.7 for muscle tissue (day 3), and 12.2 for viscera tissue (day 21) Terrestrial Field Dissipation (total system; non
- linear) t 1/2 = 1155, 3466, 2310, 990, 408, 1733, 105, 99, 696, and 261days A http://sitem.herts.ac.uk/aeru/footprint/en/Reports/353.htm B http://www.google.com/search?hl=en& q=Flutriafol+kOW In addition to the new active ingredient, the Agency has identified concerns with the new formulated product ( Flutriafol 125 g/L SC ). For risk assessment purposes, this assessment considers exposure to the active ingredient , as well as its formulated product, Flutriafol 125 g/L SC
. 2. Overview of Pesticide Usage Cheminova, Inc. is seeking the registration of flutriafol as a new fungicide for use to control fungal diseases on soy

beans and apples
. Flutriafol is formulated as a soluble c oncentrate (Flutriafol 125 g/L SC) for broadcast foliar application to crops through ground and aircraft spray equipment
. Flutriafol 125 g/L SC is labeled as TOPGUARD TM for agricultural use. Further characterization of the use is provided in Section III -A
. C. Receptors Registrant
- submitted toxicological studies with surrogate test species will be utilized for this baseline risk assessment for flutriafol ( Table II - 2 ). T oxicological 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 taxonomic groupings. A complete discussion of all toxicity data available for this risk assessment for TGAI , formulat ed products , and the resulting measurements of effect selected for each taxonomic group are included in Section III.C and Appendix F
.21

The receptor is the biological entity that is exposed to the stressor (EPA, 1998). A cute and chroni c toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate the potential direct effects of flutriafol to the aquatic and terrestrial receptors identified in this section. This includes tox icity data on the tec hnical grade active ingredient and its formulated products. The open literature studies are identified through EPA’s ECOTOX database http://cfpub.epa.gov/ecotox/), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial and aquatic plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of flutriafol on biotic communities f rom loss of species that are sensitive to the chemical and from changes in structure and functional characteristics of the affected communities. 1. Aquatic Effects The toxicity

of flutriafol technical to aquatic animals and plants is assessed using acute and chronic laboratory

studies submitted by

the registrant to the Agency . Acute toxicity data for flutriafol technical are available for surrogate freshwater fish, the rainbow trout ( Oncorhynchus mykiss ) and bluegill sunfish ( Lepomis macrochirus ), as well as for a surrogate f reshwater invertebrate, the water flea ( Daphnia magna ). Acute toxicity data for flutriafol technical are available for surrogate estuarine/marine fish, sheepshead minnow ( Cyprinodon variegatus ), as well as for surrogate estuarine/marin e invertebrates, Eastern oy ster (Crassostrea virginia) and mys id shrimp (Americamysis bahia). D ata are available to evaluate chronic effects to freshwater fish (rainbow trout) and invertebrates (water flea). The potential chronic effects to estuarine/marin e fish and invertebrates are uncertain because chronic toxicity data for flutriafol technical are not available
. T oxicity studies are available to evaluate the effects of flutriafol to aquatic plants. Effects data for freshwater fish and invertebrates are available for the flutriafol formulat ed product, Flutriafol 125 g/L SC. Effects to aquatic animals and plants from flutriafol degradates are not available ; therefore , the toxicological concern s to those species are uncertain. S ince measured residue of the degradates are less than 10% of parent equivalents and a structure anal ys is of the degradates suggest s that the degradates are less toxic than the parent compound to aquatic animals , it is likely that the degradates are not a toxicological concern
. An exception to this is the minor degradate 1,2,4
- triazole. This degradate is a common degradate to other conazole fungicides and its fate properties and toxicity

will be addressed b y the Agency in a separate assessment. 2. Terrestrial Effects The effe ct of flutriafol technical on all bird species is estimated from acute, subacute and chronic studies on two preferred species, bobwhite quail ( Colinus virginianus ) and mallard duck ( Anas platyrhynchos ) and an acceptable upland game bird species, the red
- le gged partridge ( Alectoris rufa)
. However, data are not available for passerine birds. These bird species also act as surrogates for reptiles and terrestrial
- phase amphibians when data on those species are not available . Effects of flutriafol technical and its formulated product on mammals are estimated from acute and chronic rat studies reviewed b y the Registration Division (RD) and Health Effects Division (HED).22

A cute contact honey

bee toxicity

test s with flutriafol technical and flutriafol formulat ed pro ducts (IMPACT®, SC JF 8496) are available to assess the potential risk to non
- target terrestrial invertebrates. Terrestrial plant studies (seedling emergence and vegetative vigor) are available to evaluate the effects of flutriafol to terrestrial monocot s and dicots. Effects to terrestrial animals and plants from flutriafol degradates were not available ; therefore , the toxicological concerns to those species are uncertain
. S tructure anal ys is suggest s that the degradates are less toxic than the parent c ompound to aquatic animals . It may be similarly

the case that the degradates are not a toxicological concern to terrestrial animals and plants. Table II - 2 provides a summary of the taxonomic groups and the surrogate species tested to provide potential acute ecological effects data to non - target animals and plants
. Inaddition, the table provides a preliminary overview of the potential acute toxicity of flutriafol by

providing the acute toxicity

classifications. Table II - 2. Test Species Evaluated for Assessing Potential Ecological Effects of Flutriafol TGAI and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification Birds 1 [Oral ] Mallard duck ( Anas platyrhyncho s ) [Oral] Bobw

hite quail ( Colinus virginianus ) [Oral] Red
- legged p artridge ( Alectoris rufa ) Slightly to p ractically non - toxic [ Dietary] Mallard duck (

Anas platyrhynchos ) [Dietary] Bobwhite quail ( Colinus virginianus ) Slightly to p ractically non - toxic Mammals Laboratory rat (Rattus norvegicus ) Laboratory mouse (

Mus musculus) Moderately to slightly toxic Beneficial insects Honey bee ( Apis melli fera L. ) Practically non
- toxic Freshwater fish2 Bluegill sunfish ( Lepomis macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Slightly toxic Freshwater invertebrates W ater flea ( Daphnia magna ) Slightly toxic Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus ) No more than slightly toxic Estuarine/marine invertebrates Eastern Oyster ( Crassostrea virginica ) My sid ( Americamysis bahia ) Slightly toxic
Terrestrial plants 3 [ Seedling Emergence and Vegetative Vigor ] Monocot

– Corn, Onion, Ryegrass, Wheat [ Seedling Emergence and Vegetative Vigor ] Dicot

– Cabbage, Lettuce, Radish , Soybean, Sugar beet , Tomato Not classified
Aquatic plants and algae Vascular

– Duckweed ( Lemna gibba ) Non
- Vascular
- Green algae (Pseudokirchneriella subcapitata ) , Blue
- green algae ( Anabaena flos

- aquae ), Freshwater diatom (

Navicula pelliculosa ), Marine diatom ( Skeletonema costatum ) Not classified

1 Birds represent surrogates for amphibians (terrestrial phase) and reptiles. 2 Freshwater fish may be surrogates for amphibians (aquatic phase). 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.23

3. E cosystems at Risk The terrestrial ecos ys tems ty picall y at risk include the treated area and areas immediately adjacent to the treated are a that might receive spray drift, runoff, or wind
- erosion of soil particles. Aquatic ecos ys tems ty picall y at risk include water bodies receiving runoff and /or drift from treated sites
. For both terrestrial and aquatic animal species, direct and indirect acute and chronic exposures are considered. Risk will be assessed to terrestrial plants assumed to exclusively occur in areas immediately

adjacent to, and in transition areas receiving runoff and spray drift from treated areas. The labeled uses of f lutriafol could result in exposure to aquatic and terrestrial animals and plants inhabiting flowing, non
- flowing or transient freshwater/marine water bodies , wetlands and transitional areas, and to wild lands (forests and ecotones, such as edge and riparian habitats) adjacent to the agricultural use of flutriafol . For uses in coastal areas where apples are grown , aquatic habitat also includes marine and estuarine ecos ys tems . D. Assessment Endpoints Assessment endpoints are defined as “explicit express ions of the actual environmental value that is to be protected.” Defining an assessment endpoint involves two steps: 1) identifying the valued attributes of the environment that are considered to be at risk; and 2) operationall y defining the assessment end point in terms of an ecological entity (i.e., a community

of fish and aquatic invertebrates) and its attributes (i.e., survival and reproduction). Therefore, selection of the assessment endpoints is based on value entities (i.e., ecological receptors), the ecos ys tems potentially

at risk, the migration pathway s of pesticides, and the routes by which ecological receptors are exposed to pesticide
- related contamination. The selection of clearl y defined assessment endpoints is important because they provide dire ction and boundaries in the risk assessment for addressing risk management issues of concern. A summary

of the assessment and measurement endpoints selected to characterize potential ecological risks associated with exposure to flutriafol are summarized in Table II - 3 . The ecological relevance of selecting these assessment endpoints is as follows: 1) complete exposure pathway s exist for these receptors , 2) the receptors may be potentially

sensitive to pesticides in affected media and in residues on plants, seeds, and insects , and 3) the receptors could potentially

inhabit areas where pesticides are applied or areas where runoff and/or drift may impact the sites. This ecological risk assessment estimate s exposure concentrations ba sed on labeled maximum appl ication rates, maximum number of applications, and minimum intervals between applications. E xposure scenarios are proposed to evaluate potential risks to non - target wildlife and plants from flutriafol treatments in apple and soy bean sites
. Five exposure sc enarios were estimated for the proposed uses of flutriafol : 4 ground applications at maximum application rate of 0.11 lbs ai/A with a 7 day reapplication interval ; 3 ground applications at 0.06 lb ai/A with a 21 day reapplication interval; 3 aerial application s at 0.06 lb ai/A with a 21 day reapplication interval; 3 ground applications at 0.06 lb ai/A with a 14 day interval; and 3 aerial applications at 0.06 lb ai/A with a 14 day interval.24

This assessment is intended to represent high
- end exposures at a national level. Likewise, the most sensitive toxicity

endp oints are used from surrogate test species to estimate treatment
related direct effects on acute mortality and chronic reproductive, growth and survival assessment endpoints. Toxicity tests are intended to determine effects of pesticide exposure on birds, mammals, fish, terrestrial and aquatic invertebrates, and terrestrial and aquatic plants. These tests include short
- term acute, subacute, and reproduction studies and are typicall y arranged in a hierarchical or tiered s ys tem that progresses from basic laboratory tests. The toxicity studies are used to evaluate the potential of a pesticide to cause adverse effects, to determine whether further testing is required, and to determine the need for pre cautionary label statements to minimize the potential adverse effects to non
- target animals and plants (CFR 40 §158.202, 2002). In order to protect threatened and endangered species, all assessment endpoints are measured at the individual level. Measuring endpoints at the individual level also provides insight about risks at higher levels of biological organization (e.g. populations and communities). For example, pesticide effects on individual survivorship have important implications for both populati on growth increase and habitat carrying capacity
. E. Conceptual Model 1. Risk Hypotheses Risk hy potheses are specific assumptions about potential adverse effects (i.e. changes in assessment endpoints) and may be based on theory

and logic, empirical data , mathematical models, or probability

models (EPA, 1998). For this assessment, the risk is stressor
- linked, where the stressor is the release of flutriafol to the environment. The following risk hy pothesis is presumed for this baseline assessment. The use of

flutriafol and its formulated product as a fungicide for terrestrial outdoor uses will result in exposure to terrestrial and aquatic animals and plants
. Based on the persistence and mobility of

flutriafol , the mode of action, the application methods, and food

- web of the target terrestrial ecosystems, flutriafol and its formulated product have the potential to cause reduced survival, and reproductive and growth impairment for both terrestrial and aquatic animal and plant species. 2. Conceptual Model The conceptual model is used to depict the potential routes of exposure from flutriafol and its formulated product when used as a fungicide on apples and soy beans in terrestrial outdoor settings. All potential routes of exposure are considered and presented in the conceptual model ( Figure 2 ). The conceptual model generically depicts the potential source of flutriafol, release and transport mechanisms, receiving media, biological receptor types, and effects endpoints of potential concern. In order for a chemical to pose an ecological risk, it must reach ecological receptors in25

biologicall y significant concentrations. An exposure pathway is the means by which a contaminant moves in the environment from a source to an ecological receptor. For an ecologic al exposure pathway to be complete, it must have a source, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure. The assessment of ecological exposure pathway s, therefore, includes an examinatio n of the source and potential migration pathway s for constituents, and the determination of potential exposure routes ( e.g. , ingestion, inhalation, dermal contact). Potential exposure pathway s by which flutriafol may

inadvertentl y affect non
- target plant and animal populations in aquatic areas are drift during spray application and runoff/leaching of contaminated water from treated areas to untreated areas. In semi
- aquatic areas, the exposure routes are drift during spray application, runoff events (off
- s ite movement of contaminated water), leaching, atmospheric transport, and wind erosion of contaminated soil particles. There may be exposure to non
- target terrestrial plants adjacent to treated areas via drift, runoff and atmospheric transport from transi tional sites or wetlands that may be dry during certain periods, or via wind
- blown treated soil particles from those pathway s for aquatic species. In addition, sediment
- dwelling organisms may be exposed to flutriafol because the pesticide is expected to b e persistent in water
. Exposure through aquatic media will mainly be to the parent compound since flutriafol is persistent in the environment.26 Application of Flutriafol and its Formulation Product to Apples and Soybeans through Ground and

Aerial Spray Equipment in Agricultural Settings Stressor
Direct Ground Deposition Volatilization/ Wi nd Suspension Leaching

No n - Target Plants:
• Seedling emergence
• Vegetative v igor
• Re du ctions in cell density/ biomass in aquatic plants Source: Transport P athw ay

Terrestrial Animals:

• Le thality
• Reproductive/developmental effects Aquatic Animals and Plants:
• Effects to survival, growth, and reproduction Source: Exposure Media

Exposure Point

Re ceptors

Attribute Changes Terrestrial Food Residues (foliage, fruit, insects)

Direct Contact & Ingestion

Terrestrial Vertebrates and Invertebrates Direct Contact/ Ro ot Uptake

Terrestrial Upland Plants Surface Wa ter Sediment Groundwater

Gill/Integument Uptake
Aquatic Invertebrates & Vertebrates Upland Soil and Foliage Riparian/ We tland Foliage/Soil Spray Drift Runoff/ Erosion

Uptake/ Adsorption Riparian/ We tland Plants Aquatic

Plants

Plant Population Re du ced Population growth

Figure 2. Flutriafol Environmental Risk Conceptual Model Solid line indicate possible pathway Bolded line indicate likely pathway27

F. Analy sis Plan In order to address the risk hy pothesis, the potential for adverse effects on non
- target aquatic and terre strial animals and plants is estimated. In the following sections, the use, environmental fate, and ecological effects of flutriafol and it s formulat ed product are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to effects concentration) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient
- based approach does not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. Such estimates may be possible through a more refined, probabilistic assessment; however, they are be yond the scope of this baseline assessment. This analy sis provides the basis for estimating and describing risks, identifying uncertainties in the risk hy pothesis, and recommendations for new data collection if needed to fill the data gaps
. This assessment only

considers the potential effects of flutriafol fungicide exposure as a result of the currently proposed uses. The Agency does not routinely

include an evaluation of mixtures of active ingredients, either those mixtures of multiple active ingredients in product formulations or those in the applicator’s tank. In the case of the product formulations of active ingredients (that is, a registered product containing more than one active ingredient), each active ingredient is subject to an individual risk as sessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing the active ingredient, they

may be used qualitatively

or quantitatively

in accordance with the Agen cy ’s Overview Document and the Services’ Evaluation Memorandum (U.S., EPA 2004; USFWS/NMFS 2004). For this baseline ecological risk assessment, estimated environmental concentrations (EECs) for aquatic and terrestrial s ys tems were calculated using expos ure scenarios for soy bean and apple use according to label information. EECs were calculated using T
- REX (version 1.3.1), GENEEC2 (version 2.0 ), PRZM (Version 3.12.2) /EXAMs (Version 2.98.04 ), and the AgDRIFT (V ersion 2.0.1). Baseline terrestrial and aquatic concentrations represent values for a generic crop grown in a generic location which have been chosen to represent all crop uses. EECs, and the resulting risk quotients from the TerrPlant model for terrestrial plants growing in dry and semi
- aquatic enviro nments, are generated by using the seedling emergence and vegetative vigor toxicity information at the maximum proposed application rate. 1. Preliminary Identification of Data Gaps and Methods The environmental fate database for parent compound flutriafol is essentially complete. The available data are generally sufficient for risk assessment purposes of the parent compound, flutriafol. Several studies (e.g. terrestrial field dissipation) are classified as supplemental due to a failure to identify

all pos sible toxic degradation products. The triazol degradate, which was identified in studies where both major and minor degradates were characterized, is a common degradate to proposed and registered conazole pesticides. A cumulative assessment for residues of the triazol degradate has been separately assessed by

OPP for human health effects. They will be assessed separately for ecological effects by EFED at a later date, and are not included in28

this assessment
. The ecological toxicity

database for flutri afol is largely complete for terrestrial and aquatic animals and plant species. The following uncertainties and information gaps are identified as part of the problem formulation: An avian acute oral ecological toxicity study with passerine birds is required to satisfy EPA guidelines. Toxicity data on sediment dwelling animals are not available. Even though flutriafol is expect ed to persist in the environment and repeated applications may lead to accumulation of flutriafol residues in the sediment, th e toxicity of the AI to those animals is uncertain . Based on the high toxicity of flutriafol to other aquatic animals , toxicity data on sediment dwelling animals would greatl y strength en this assessment. There are additional uncertainties associated with using the acute
- to - acute ratio (AAR) and acute - to - chronic ratio (ACR) to estimate acute and/or chronic toxicity values for aquatic animals. The ratios derived for these aquatic animals assume that the ratios from different species are conserve d across sp ecies (i.e., sunfish to minnow) . I f data on the specific species are submitted and are higher or lower than the derived toxicity value for these aquatic animals, then risk could be under
- or over - estimated, respectivel y. 2. Measures of Exposure and Effects
a. Measures of Exposure Aquatic Animals and Plants Tier I simulation model GENEEC2 (Version 2.0; August 1, 2001 ) and Tier 2 PRZM (Version 3.21.2)/EXAMS (2.98.04) are used to generate estimated environmental concentrations (EECs) of the active ingre dient
. The predicted peak, 21
- day , and 60
- day concentrations are used to estimate acute and chronic risks to aquatic animals inhabiting shallow
- water aquatic communities that receive runoff during rainfall events and/or drift of the active ingredient from adjacent use sites. GENEEC2 assumes application of the active ingredient to a 10
- hectare agricultural field, planted solely in a generic crop, that drains into an adjacent 1
- hectare water body, 2 meters deep (20,000 m 3 volume) with no outlet. This gene ric agricultural scenario is representative of flutriafol use on apples and so ybeans, and is likely to result in conservative estimates of exposure. GENEEC2 considers adsorption of the active ingredient to soil or sediment, direct deposition of spray drif t into the water body, and degradation of the pesticide in soil before runoff and within the water body . It is a single event model, meaning that it assumes one single large rainfall/runoff event from a standard size field to a standard size ecological po nd.29

PRZM/EXAMS modeling assumes application of the active ingredient to a 10
- hectare agricultural field that drains into an adjacent 1
- hectare water body , 2 meters deep (20,000 m 3 volume ) with no outlet. Unlike GENEEC2, PRZM/EXAMS modeling considers site s pecific properties (ie, soil type and meterology) and agronomic practices (ie, pesticide application timing, pesticide application method) for specific crops. Thirty year model simulations are conducted to provide an estimate of 1 in 10 year peak, 21
- day average and 60 day average EECs. Model input parameters are selected based on laboratory fate data in accordance with EFED’s input parameter guidance 5

. Tier I modeling is conducted based on the maximum potential number of applications , maximum appli cation rate s, and the shortest application interval. Five exposure scenarios were estimated for the proposed uses of flutriafol: 4 ground applications at maximum application rate of 0.11 lbs ai/A with a 7 day reapplication interval; 3 ground applications at 0.06 lb ai/A with a 21 day reapplication interval; 3 aerial application s at 0.06 lb ai/A with a 21 day

reapplication interval; 3 ground applications at 0.06 lb ai/A with a 14 day interval; and 3 aerial applications at 0.06 lb ai/A with a 14 day interval
. Tier II PRZM/EXAMS modeling was conducted for apples using 4 ground spray applications at a maximum application rate of 0.11 lbs ai/A with a 7 day reapplication interval. In circumstances whe re toxicity data with the formulated product were available, A gDRIFT (Version 2.1) was used to generate estimated environmental concentrations (EECs) for the formulat ed product that may drift immediately to water bodies adjacent to the application sites. The predicted spray

drift EECs were used to estimate risk to aquatic animals and plants inhabiting shallow
- water aquatic communities that receive incidental spray drift of the formulated product from adjacent use sites. Terrestrial Animals and Plants The potential exposure pathway s for terrestrial plants and animals include deposition from spray applications, runoff/leaching from treated areas, spray drift, and wind erosion of soil particles resulting in residues on non
- target species as well as residues on food items for non
- target species. As part of the terrestrial assessment, EFED used the model s T
- REX (ver. 1.3.1.) and TerrPlant (ver. 1.2.2) to estimate exposure concentrations of flutriafol to non
- target terrestrial animals and plants, respectively
. T
- REX assumes application of the active ingredient to a one
- acre agricultural field that settles on food items of avian and mammalian species (short and tall grass, broadleaf forage, large and small insects, fruits, pods, and seeds) within the field. TerrPlant assumes application of the active ingredient to a one
- acre agricultural field that drifts and/or is subject to runoff off site to adjacent fields of non
- target plants. AgDRIFT (Version 2.1) was used to estimate environmental concentrations (EECs) of the end
use product that may

drift to areas adjacent to the application sites. The predicted spray drift EECs are used to estimate risk to terrestrial animals inhabiting the edge of the field that receive incidental spray

drift of the formulated product from adjacent use sites.

5 http://www.epa.gov/oppefed1/models/water/input_guid ance2_28_02.htm30 b. Measures of Effects Measures of ecological effects are obtained from submitted guideline studies conducted with a limited number of surrogate species on flutriafol . 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 lab oratory

conditions and their standardized use for toxicity studies of a variety

of chemicals. S ubmitted ecological effects data comply with good laboratory

testing requirements. These data are summarized in the Ecologica l Effects Section and in Appendix F
. As stated above, toxicity

testing does not represent all species of birds, mammals, or aquatic animals. Only

a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish (2000 +) and bird (680+) species in the United States. For mammals, acute studies are usuall y limited to the laboratory rat. Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish. In addition, neither reptiles nor amphibian data a re available. The risk assessment assumes that avian, terrestrial
- phase amphibian and reptilian toxicities are similar. The same assumption is used for fish and aquatic
- phase amphibians. A summary

of the assessment and measurement endpoints selected to characterize potential ecological risks associated with exposure to technical grade , the active ingredient in the formulated product, and its formulated product are summarized in Table II -3
.

Table II - 3 . Summary of Assessment Endpoints and Measures of Ecological Effects * Assessment Endpoint Surrogate Species and Measures of Ecological Effect 1 Me asures of Exposure
Birds 2 Survival Partridge a cute oral LD 50 Bobwhite and mallard subacute dietary LC 50 Upper bound residues on food items (foliar) Reproduction and growth Bobwhite and mallard chronic reproduction NOAEC and LOAEC Mammals Reproduction

and growth Laboratory rat oral reproduction chronic NOAEC and LOAEC Survival Laboratory mouse acute oral LD 50 Laboratory rat acute oral LD 50 Spray dri ft EEC 6
Freshwater fish 3 Survival Rainbow trout and bluegill sunfish acute LC 50 Peak EEC 4 Spray drift EEC 7 Reproduction and growth Freshwater fish chronic (early life
- stage) NOAEC and LOAEC 60
- day average EEC 4
Freshwater invertebrates Survival Water flea acute EC 50 Peak EEC 4 Spray drift EEC 7 Reproduction and growth Water flea chronic (life cycle) NOAEC and LOAEC 21
- day average EEC 4

Estuarine/marine fish Survival Sheepshead minnow acute LC 50 Peak EEC 4 Spray drift EEC 7 Reproduction and growth Sheepshead minnow chronic (early life
- stage) NOAEC and LOAEC * (no study available) 60
- day average EEC 4 Estuarine/marine Survival Eastern oyster acute EC 50 and mysid acute LC 50 Peak EEC 431 Table II - 3 . Summary of Assessment Endpoints and Measures of Ecological Effects * Assessment Endpoint Surrogate Species and Measures of Ecological Effect 1 Me asures of Exposure invertebrates Spray drift EEC 7

Reproduction and growth My sid chronic NOAEC and LOAEC * (no study available) 21
- day average EEC 4 Terrestrial plants 5 Survival and grow th Monocot and dicot seedling emergence and vegetative

vigor EC 25 and NOAEC (or EC 05 ) values Estimates of runoff and spray drift to non
- target areas Insects Survival (not

quantitatively assessed) Honeybee acute contact LD 50 Maximum application rate Aquatic plants and algae Survival and

grow th Algal (marine diatom) and vascular plant (duckweed) EC 50 and NOAEC values for grow th rate and biomass m easurements Peak EEC 4 Spray drift EEC 7

1 If species listed in this table represent most commonly encountered species from submitted studies, risk assessment guidance indicates most sensitive species tested within taxonomic group are to be used for ba seline risk assessments. 2 Birds represent surrogates for amphibians (terrestrial phase) and reptiles. 3 Freshwater fish may be surrogates for amphibians (aquatic phase). 4 Based on GENEEC2 active ingredient modeling
. 5 Four species of two families of mono cots - one is corn, six species of at least four dicot families, of which one is soybeans. 6 Based on AgDRIFT modeling; only used when mammal acute oral toxicity data with the formulat ed product is available. 7 Based on AgDRIFT modeling; only used when aquatic animal and plant acute toxicity data with the formulat ed product is available. * LD 50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; LOAEC = Lowest observed adverse effect concentration; LC 50 = Lethal concentration to 50% of the test population; EC 50/EC 25 = Effect concentration to 50%/25% of the test population. III. ANALYSIS A. Use Characterization C heminova In c. is seeking the registration for the new active ingredient, flutriafol, for use to control fungal disease s on apples and soy beans. Flutriafol can be formulated as a soluble concentrate. Methods of application include foliar broadcast spray via ground or air. To control fungal diseases on apples, a maximum application rate of 0.11 lbs ai/A with no more than four applications per season is proposed. The shortest reapplication interval for apples is 7 day s. For flutriafol treatments in soy bean fields to control soy bean rust as per label information, a maximum application rate of 0.06 lbs ai/A applied no more than 3 times with 21
- day reapplication intervals is recommended. F or control of frogeye leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew in soybean fields , the label recommends 3 applications at 0.06 lbs ai/A with a reapplication interval of 14 day s. This risk assessment focuses exclusively on the use patterns of flutriafol for control of susceptible fungal diseases on apples and so yb eans. Use patterns tabulated in Table III - 1 below serve as the basis for selecting the appropriate application rates and method used as part of the input parameters needed to obtain EECs with simulation models.32

Table III - 1. Flutriafol Application Information Metho d of Application Crop Maximum Application Rate l b a.i./A Maximum Number

of Applications (Interval) PHI

(Days) Maximum

Seasonal Use Rate lb a.i./A Broadcast Foliar Spray (ground) Apple 0.11 4 applications (7 to 14
- day interval) 14 0.4 4 Broadcast Foliar Spray (ground & aerial) Soybean 0.06 3 application s (21 to 35
- day interval) 21 0.23 Broadcast Foliar Spray (ground & aerial) Soybean 0.06 3 applications ( 14 to 21
- day interval) 21 0.23 B. Exposure Characterization 1. Environmental Fate and Transport Characterization
a. Summary Flutriafol is a con azole fungicide that is expected to be persistent and moderatel y mobile in the environment with the major routes of d egradation through biotic processes . L aboratory anaerobic aquatic data suggests more rapid degradation in aquatic environmental compartments (t 1⁄2 = 6 weeks). Flutriafol has a half
- life of greater than one ye ar in soil , and therefore repeated applications may

lead to accumulation in soil . Flutriafol is expected to reach surface water through drift, atmospheric transport (as indicated by det ection in Arctic ice samples) , runoff, leaching, and/or erosion
. Based on PRZM modeling, the dominant route of dissipation for flutriafol is leaching below the root zone. These modeling data are consistent with observations of flutriafol leaching in fiel d dissipation studies as well as laboratory mobility data. Table III - 2. Environmental Fate Properties of Flutriafol PARAMETER VALUE SOURCE COMMENT Molecular Weight 301.3 amu Calculated Henry’s Law Constant 1.3 x 10 - 11 atm x m 3 x mol - 1 Vapor Pressure 4 x 10 - 7 Pa (25 ○ C) Aqueous Solubility 130 mg/L Hydroly sis half
- life < 1 year MRID 47090416 (pH 4 7, 9) Aqueous Photolysis half
- life < 1 year MRID 47287601

MRID 47090417 Photodegradation on Soil half
- life = 72.2 days MRID 474 18401 Continuous irradiation Aerobic Soil Metabolism half
- lives = 6,932, 840, 1127, 1799, 588, 686, 2205

days MRID 47090421

MRID 4709042233

Table III - 2. Environmental Fate Properties of Flutriafol PARAMETER VALUE SOURCE COMMENT Aerobic Aquatic Metabolism (total system) half
- lives = 42.6 and 36.3 days MRID 47090419 Anaerobic Soil Metabolism (total system) half
- liv e s = 6,932, 840, 1127, 1799, 588, 686, 2205

days MRID 470090424 Soil Partition Coefficient (Kd) 3.7, 13.6, 10.6, 6.5, 2.0 MRID 47090425 MRID 47090426 MRID 47090427 Koc = 264, 340, 428, 140, 498, 205, 379
Bioconcentration in Fish 4.7 X 12.2 X 6.8 X M RID 47090437 edible tissue visceral tissue whole fish

Terrestrial Field Dissipation (total system) half
- life = 1155 days; half
- life = 3466 days, half
- life = 2310 days, half
- life = 1155 days, half
- life = 866 days, half
- life = 770 days, half
- life = 866 days, half
- life = 1155 days, half
- life = 1386 days. MRID 47115502 MRID 47090431 - West Horsley, United

Kingdom Loamy sand.

- Boxford, United Kingdom

- Clay loam.

- Chalgrove, United Kingdom Sandy clay loam.

- Lichtenhagen, Germany soil type not reported.

- Lichtenhagen, Germany soil type not reported

- Mottingen, Germany soil type not reported.

- Damsdorf, Germany soil type not reported

- Bohringen, Germany/ soil type not reported

- Wankendorf, Germany soil type not reported b. Persistence and Transformation Flutriafol is stable to both hydrol ys is and aquatic photoly sis , and moderately resistant to photodegradation on soil
. Flutriafol biodegrades with half
- lives of more than a ye ar under aerobic and anaerobic conditions , in both terrestrial and total
- system aquatic environments. Laboratory

anaerobic aquatic data suggests more rapid degradation in aquatic environmental compartments (t 1⁄2 = 6 weeks). On the whole, f lutriafol is expected to degrade with a half
- life of more than one ye ar in the environment. Repeated applications may lead to accumulation of flutriafol residues in soil. As a result, it is expected to persist for years, and to build up with successive annual applications in both aerobic and anaerobic environments
. The degradates of flutriafol were onl y reported in two studies, a soil photoly sis study and an anaerobic aquatic metabolism study

include 1 ,2,4
- triazol e , triazole acetic acid , triazole alanine , 2,4’
- difluorobenzophenone , and c arbon dioxide
.34 c. Transport and Mobility Batch equilibrium data on flutriafol suggest that the compound will sorb to soil with moderate affinity and display

moderate mobility (Kd values range from 2.0 to 13). Because f lutriafol biodegrades with half

- lives of more than a year under aerobic and anaerobic conditions , in both terrestrial and total
- system aquatic environments , there is a potential for build
- up in soil with repeat ed applications
. Because leaching, runoff, erosion, and accumulation in soil are probable processes controlling the environmental fate of flutriafol, PRZM modeling was conducted to assess the contribution of each process in controlling the environmental fate of flutriafol under field conditions. The PRZM modeling was conducted using the standard MS soybean scenario (Appendix M ). Extensive accumulation of flutriafol residues in soil was not observed in the MS soy bean scenario (Figure 3). The time seri es of soil flutriafol concentration s in the surface 10
- cm of soil indicates rapid d ecline after the initial spike resulting from flutriafol applications. This observation was not expected because of the high persistence of flutriafol in soil. Nevertheles s, after the initial spikes and declines, flutriafol concentrations remained steady at an elevated level f or the duration of the simulation.

Day 0 500 1000 1500 2000Soil Concentration (mg/kg)

0.0 0.2 0.4 0.6 0.8 1.0 1.2

Figure 3 : Time Series of Flutriafol Concentrations in Surface Soil (10 cm depth) for the MS Soybean Scenario Additional PRZM modeling was conducted to explain the lack of flutriafol accumulation in the surface soil layer in the MS soy bean scenario. Table III
- 3 illustrates the relative contribution of probable dissipation pro cess on applied flutriafol over 30 year s of PRZM simulation
.35

Table III - 3 : Contribution of Dissipation Processes for Flutriafol Use on Soybeans in MS Compound Percentage of Applied Parent Compound in Leachate, Runoff, Erosion Leaching Runoff Eros ion Flutriafol 67.060 0.100 0.001 Based on the above anal ysis, the predicted dominant route of dissipation for flutriafol is leaching below the root zone; the contributions from runoff and erosion are much less. These modeling data are consistent with observations of flutriafol leaching in field dissipation studies as well as laboratory

mobility data. Although this compound has a partial vapor pressure of 400 nPa 2.5 x 10 - 8 torr at 26°C and a Henry ’s Law Constant of 1.3 x 10 - 11 atm x m 3 x mol - 1 , wh ich would indicate a low likelihood for dissipation into the atmosphere, i t has been observed that long
- range atmospheric transport can move flutriafol at least as far as the surface of Norwegian ice caps 6

.

d. Field Studies Dissipation occurred with h alf
- lives between 106 to 13,566 day s in terrestrial field studies
. This is consistent with the submitted, laboratory
- derived data. Due to the length of the studies, and the persistence of flutriafol, major degradates were not detected in either laboratory or field studies. Had these studies been conducted for greater length of time, it is conceivable that degradation products may have formed at concentrations greater than ten percent of parent equivalents
. 2. Measures of Aquatic Exposure
a. GENEEC2 E xposure Model ing The Tier I simulation GENEEC2 (Version 2.0; August 1, 2001) is used to determine EECs for aquatic exposure resulting from use of flutriafol on terrestrial outdoor sites
. GENEEC2 uses a standard pond scenario which a ssumes application of the active ingredient to a 10
- hectare agricultural field that drains into an adjacent 1
- hectare water body , 2 meters deep (20,000 m 3 volume) with no outlet. GENEEC2 considers adsorption of the pesticide to soil or sediment, incorporation of the pesticide at application, direct deposition of spray drift into the water body , and degradation of the pesticide in soil before runoff and within the water body . It is a single event model, meaning that it assumes one single large rainfall/runoff event occurs and removes a large quantity of pesticide at one time from the field to a pond. The model and information about its assumptions are available at the EPA’s water modeling website, http://www.epa.gov/oppefed1/models/water/
. Model input parameters were selected according to standard input guidance and are presented in Table III - 4
. Exposure is estimated based on three use scenarios , in which the chemical is assumed by

the model to be applied over the entire 10
- ha field. Because flutriafol is used in
6 Hermanson, Mark H, et. al, Current
- Use and Legacy Pesticide History in the Austfonna Ice Cap, Svalbard, Norway , Environmental Science and Technology, 2005 , vol. 39, pp. 8163

– 8169.36

terrestrial outdoor settings, the GENEEC2 model is used to derive Estimated Environmental Concentrations (EECs) for the three use scenarios that are assumed to be conservative and likel y to be representative of exposure occurring in an agricultural setting
. Table II I - 4. Summary of Flutriafol Environmental Fate Data Used for the Aquatic Ecological Effects Assessment Inputs for Tier I GENEEC Modeling

Fate Property Input Value MRID (or source) Molecular Weight 301.3 Aqueous Solubility 130 m g/L Aqueous Photol ysis Half
- Life stable 47287601 47090417 Aerobic Soil Metabolism Half
- Life stable (time 1⁄2 = 6,932 , 840, 1127, 1799, 588, 686, 2205 days ) 47090421 47090422 Hydroly sis Half

- Life stable 47090416 Aerobic Aquatic Metabolism Half
- Life ( total system) Stable b ased on uncertainty in whole system data (water colum n only = 49.2 days ) 90% confidence bound calculated in accordance with water model input guidance 47090419 Anaerobic Aquatic Metabolism Half
- Life (benthic) stable 470090424 Koc 140 ( lowest non - sand v alue) 47090425 47090426 47090427 Application Efficiency Apples Soybeans 99 percent 99 (ground) and 95 percent (aerial) EFED Guidance Crop Managem ent Maximum Application Rate Apples Soybeans 0. 11 lb. a.i./acre 0.06 lb. a.i./acre Product Label (67760
- TL ) Maximum Num

ber of Applications Apples Soybeans 4 3 Product Label (67760
- TL ) Application Interval Apples Soybeans 7 days 21 days Product Label (67760
- TL ) Application Method Apples Soybeans ground ground and aerial Product Label (67760
- TL ) Incorporation Depth 0 cm Product Label (67760
- TL )

b. GENEEC2 Mo d eling Results Aquatic active ingredient EECs generated from GENEEC2 for the labeled uses of flutriafol on terrestrial outdoor sites are listed in Table III - 5
. These results represent peak and 4
- , 21
- , 60
- , and 90
- day

average estimates of surface water concentrations in the standard farm pond for use as acute and chronic exposure endpoints. The results for the maximum exposure scenario s , appropriate for use in calculating baseline risk quotients, are presented in bold; other values are provided for characterization purposes. Model output files for these estimates are in Appendix B .1
.37

Table III - 5 . Surface Wat er EECs for the Proposed Uses of Flutriafol on Apples and Soybean Calculated by GENEEC2

Scenario Peak (μg ai/L) 96 Hour

(μg ai/L) 21 Day

(μg ai/L) 60 Day

(μg ai/L) 90 Day

(μg ai/L) Ground Spray to Apples (0.11 lb ai/A x 4 apps x 7 D intervals) 21.2 21 .2 21.1 20.9 20.7 Ground Spray to Soybeans (0.06 lb ai/A x 3 apps x 14D intervals) 8.7 8.7 8.6 8.5 8.5 Aerial Spray to Soybeans (0.06 lb ai/A x 3 apps x 14D intervals) 10.1 10.1 10.0 10.0 9.9 Ground Spray to Soybeans (0.06 lb ai/A x 3 apps x 21D intervals) 8.7 8.7 8.6 8.5 8.5 Aerial Spray to Soybeans (0.06 lb ai/A x 3 apps x 21D intervals) 9.0 9.0 9.0 8.9 8.8

c. PRZM/EXAMs Exposure Modeling Tier II PRZM/EXAMS modeling was conducted to address aquatic exposure issues for aquatic plants. Input parameter s for PRZM/EXAMS modeling are shown in Table III - 6 . Tier II estimated environmental concentrations of flutriafol are shown in Table III - 7. These results represent the 1 in 10 year peak and 4
- , 21
- , 60
- , and 90
- day average estimates of surface water concentrations in the standard farm pond for use as acute and chronic exposure endpoints
. Table II I - 6. Summary of Flutriafol Environmental Fate Data Used for the Aquatic Ecological Effects Assessment Inputs for Tier II PRZM/EXAMS Modeling

Fate Property Inp ut Value MRID (or source) Molecular Weight 301.3 Aqueous Solubility 130 m g/L Aqueous Photolysis Half
- Life stable 47287601 47090417 Aerobic Soil Metabolism Half
- Life 90 th percentile of mean = 3247 days Mean=2025 days SD=2244 days N= 7 (time 1⁄2 = 6 ,932 , 840, 1127, 1799, 588, 686, 2205 days ) 47090421 47090422

Hydroly sis Half

- Life Stable 47090416 Aerobic Aquatic Metabolism Half
- Life ( total system) 100 days for total systemhalf - life 47090419 Anaerobic Aquatic Metabolism Half
- Life (benthic) 365 day s for total systemhalf - life 470090424 Koc 322 (m ean Koc) 47090425 47090426 47090427 Application Efficiency Apples 99 percent EFED Guidance38 Crop Managem ent Maximum Application Rate Apples 0. 11 lb. a.i./acre Product Labe l (67760
- TL) Maximum Num

ber of Applications Apples 4 Product Label (67760
- TL) Application Interval Apples 7 days Product Label (67760
- TL) Application Method Apples ground Product Label (67760
- TL) Incorporation Depth 0 cm Product Label (67760
- TL)

D. PRZM/EXAMs Modeling Results Aquatic active ingredient EECs generated from PRZM/EXAM S for the labeled uses of flutriafol on terrestrial outdoor sites are listed in Table III - 7
. These results represent peak and 4
- , 21
- , 60
- , and 90
- day

average estimates of surface water concentrations in the standard farm pond for use as acute and chronic exposure endpoints. The results for the maximum exposure scenario, appropriate for use in calculating baseline ri sk quotients, are presented in bold; other values are provided for characterization purposes. Model output files for these estimates are in Appendix B .2
. Table III - 7 . Surface Water EECs for the Proposed Uses of Flutriafol on Calculated by PRZM/EXAMS

S cenario Peak (μg ai/L) 96 Hour

(μg ai/L) 21 Day

(μg ai/L) 60 Day

(μg ai/L) 90 Day

(μg ai/L) NC Apples 9.88 9.75 9.11 7.92 7.20 OR Apples 3.04 3.02 2.93 2.74 2.61 PA Apples 6.74 6.68 6.26 5.44 4.95

c. Aquatic Exposure Monitoring and Field Data No m onitoring data are available for flutriafol as this is the first registered use in the United States
. 3. Measures of Terrestrial Exposure

a. Terrestrial Exposure Modeling for Spray Applications39

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, emphasizing a dietary

exposure route for uptake of pesticide active ingredients. These exposures are considered as surrogates for terrestrial
- phase amphibians as well as reptiles. For exposure to terrestrial wildlife, such a s birds and small mammals, pesticide residues on food items are estimated, based on the assumption that animals are exposed to a single pesticide residue in a given exposure scenario. For flutriafol spray

applications, estimation of pesticide concentrations in wildlife food items focuses on quantifying possible dietary ingestion of residues on vegetative matter and insects. No field residue data or field study information is available for flutriafol ; therefore, the residue estimates were based on a nomo gram that relates food item residues to pesticide application rate. The residue EECs were generated from a spreadsheet
- based model (T
- REX version 1.3.1) that calculates the decay

of a chemical applied to foliar surfaces for single or multiple applications , and is based on the methods of Hoerger and Kenaga (1972) as modified b y Fletcher et al. (1994). Uncertainties in the terrestrial EECs are primaril y associated with a lack of data on interception and subsequent dissipation from foliar surfaces. T
- REX doe s not differentiate between aerial or ground applications, the method of application is not considered ; thus, the soy bean aerial scenario is not evaluated
. To provide potential exposure s to non - target birds and mammals based on proposed label uses of flutriafol on apples and so ybeans , residue EECs were calculated using three scenarios: four applications at 0.1 1 lb ai/A with a 7 day reapplication interval ( apple use ), three applications at 0.0 6 lb ai/A with a 21 day reapplication interval ( soy bean use to co ntrol soy

bean rust) , and three applications at 0.06 lb ai/A with a 14 day reapplication interval (soy bean use to control frogeye leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew)
. EECs were calculated using a foliar dissipation de fault half
- life of 35 day s (Willis and McDowell, 1987). The active ingredient EECs on terrestrial food items may be compared directly

with dietary toxicity data or converted to an oral dose (see Table s III - 7 and III - 8 ) . The residue concentration is conv erted to dail y oral dose based on the fraction of body weight consumed daily as estimated through allometric relationships. The risk assessment for flutriafol uses upper bound predicted residues as the measure of exposure ( Table s III - 6, - 7 , - 8 ) ; however, m ean EECs are also presented for characterization purposes
. Table I II - 6 . Terrestrial Dietary - Based EECs (Bird and Mammal) Following Flutriafol Spray Application. Uses # of App. x App.

Rate Food Item s Upper Bound EEC 1 ( mgai/kg ) Me an EEC 2 ( mgai/kg ) App les 4 applications at

0.11 lb ai/A with 7 day intervals Short Grass

Tall Grass Sm . Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 86.8 39.8 48.8 5.4 30.7 13.0 16.3 2.5 Soy bean 3 applications at

0.06 lb ai/A with 14 day intervals Short Grass

Tall Gr ass Sm . Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 33.58 15.39 18.89 2.10 11.89 5.04 6.30 0.98 Soy bean 3 applications at

0.06 lb ai/A with 21 day intervals Short Grass

Tall Grass Sm . Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 30.2 13.8 17.0 1.9 10.7 4.5 5.7 0.940 1 Used to determine the potential risk to non
- target wildlife and the need to consider regulatory action. 2 Used to further evaluate the likelihood of adverse ecological effects to non
- target species.
Table III - 7 . Terrestrial Dose - Based EECs (Birds) Following Flutriafol Spray Application. Uses # of App. x

App. Rate Food item s Avian Classes and Body Weights small mi d large 20 g 100 g 1000 g Upper Bound EEC (mg ai/kg) 1
Apples 4 applications at

0.11 lb ai/A with 7 day intervals Short Grass 98.9 56.4 25.2

Tall Grass 45.3 25.8 11.6 Sm . Insects, Broadleaf Plants 55.6 31.7 14.2 Lg. Insects, Fruits, Pods 6.2 3.5 1.6
Soy beans 3 applications at

0.06 lb ai/A with 14 day intervals Short Grass 38.25 21.81 9. 77

Tall Grass 17.53 10.00 4.48 Sm . Insects, Broadleaf Plants 21.51 12.27 5.49 Lg. Insects, Fruits, Pods 2.39 1.36 0.61
Soy beans 3 applications at

0.06 lb ai/A with 21 day intervals Short Grass 34.4 19.6 8.8

Tall Grass 15.8 9.0 4.0 Sm . Inse cts, Broadleaf Plants 19.3 11.0 4.9 Lg. Insects, Fruits, Pods 2.2 1.2 0.6 Me an EEC (mg ai/kg) 2 Apples 4 applications at

0.11 lb ai/A with 7 day intervals Short Grass 35.0 20.0 8.9

Tall Grass 14.8 8.5 3.8 Sm . Insects, Broadleaf Plants 18.5 10.6 4.7 Lg. Insects, Fruits, Pods 2.9 1.6 0.7
Soy beans 3 applications at

0.06 lb ai/A with 14 day intervals Short Grass 13.56 7.73 3.45

Tall Grass 5.74 3.27 1.46 Sm . Insects, Broadleaf Plants 7.18 4.09 1.83 Lg. Insects, Fruits, Pods 1.12 0.64 0.2 8
Soy beans 3 applications at

0.06 lb ai/A with 21 day intervals Short Grass 12.2 7.0 3.1

Tall Grass 5.2 2.9 1.3 Sm . Insects, Broadleaf Plants 6.5 3.7 1.6 Lg. Insects, Fruits, Pods 1.0 0.6 0.3 1 Used to determine the potential risk to non
- target wildlife and the need to consider regulatory action. 2 Used to further evaluate the likelihood of adverse ecological effects to non
- target species.4142 Table III - 8 . Terrestrial Dose - Based EECs (Mammals) Following Flutriafol Spray Application. Uses # of App. x App.

Rate Food item s Mam mal Classes and Body Weights Herbivores / Insectivores Granivores small mi d large small mi d large 15 g 35 g 1000 g 15 g 35 g 1000 g Upper bound EEC (mg ai/kg) 1 Apples 4 applications at

0.11 lb ai/A with 7 day intervals Short Grass 82.76 57.20 13.26

Tall Grass 37.93 26.22 6.08 Sm . Insects, Broadleaf Plants 46.55 32.18 7.46 Lg. Insects, Fruits, Pods 5.17 3.58 0.83 1.15 0.79 0.18 Soy beans 3 applications at

0.06 lb ai/A with 14 day intervals Short Grass 32.02 22.13 5.13

Tall Grass 14.68 10.14 2.35 Sm . Insects, Broadleaf Plants 18.01 12.45 2.89 Lg. Insects, Fruits, Pods 2.00 1.38 0.32 0.44 0.31 0.07 Soy beans 3 applications at

0.06 lb ai/A with 21 day intervals Short Grass 28.76 19.88 4.61

Tall Grass 13.18 9.11 2.11 Sm . Insects, Broadleaf Plants 16.18 11.18 2.59 Lg. Insects, Fruits, Pods 1.80 1.24 0.29 0.40 0.28 0.06 Me an EEC (mg ai/kg) 2 Apples 4 applications at

0.11 lb ai/A with 7 day intervals Sho rt Grass 29.31 20.26 4.70

Tall Grass 12.41 8.58 1.99 Sm . Insects, Broadleaf Plants 15.52 10.73 2.49 Lg. Insects, Fruits, Pods 2.41 1.67 0.39 0.54 0.37 0.09 Soy beans 3 applications at

0.06 lb ai/A with 14 day intervals Short Gra ss 11.30 7.85 1.78

Tall Grass 4.79 3.32 0.76 Sm . Insects, Broadleaf Plants 5.98 4.16 0.94 Lg. Insects, Fruits, Pods 0.93 0.65 0.15 0.21 0.15 0.03 Soy beans 3 applications at

0.06 lb ai/A with 21 day intervals Short Grass 10.15 7.05 1.60

Tall Grass 4.30 2.99 0.68 Sm . Insects, Broadleaf Plants 5.37 3.73 0.85 Lg. Insects, Fruits, Pods 0.84 0.58 0.13 0.18 0.13 0.03 1 Used to determine the potential risk to non
- target wildlife and the need to consider regulatory action. 2 Us ed to further evaluate the likelihood of adverse ecological effects to non
- target species.43

TerrPlant, a Tier I model, predicts EECs for terrestrial plants located in dry and semi
- aquatic areas adjacent to the treated field. The active ingredient EECs are based on the application rate , soil incorporation, runoff fraction, drift fraction and solubility of the pesticide in water and drift characteristics, which depend on ground and aerial applications. The amount of flutriafol that runs off is a proportion of the application rate and is assumed to be 5% based on flutriafol’s solubility of >100 mg/Lin water. Drift from ground and aerial app lications are assumed to be 1% and 5%, respectivel y, of the application rate. An application efficiency of 100% is assum ed for aerial application. For this terrestrial exposure assessment, ground and aerial application method s to plants for flutriafol are considered in TerrPlant , which adds the third exposure scenario

– 1 aerial application at 0.06 lb ai/A according the lab el for soy bean use which permits aerial applications
. For a standard scenario on an agricultural field when applications are occurring on land, EFED’s runoff scenario for terrestrial plants inhabiting dry areas adjacent to a field is characterized as “she et runoff” (one treated acre to an adjacent acre: a 1:1 ratio) and inhabiting semi
- aquatic or wetland areas adjacent to a field is characterized as “channelized runoff” (10 treated acre to a distant low
- lying acre: a 10:1 ratio). Details of the TerrPlant m odel and EECs are presented in Table III - 9 and in Appendix E
. TABLE III - 9 . EECs for Terrestrial Plants Located Adjacent to Flutriafol (broadcast spray application) Treated Sites. Terrestrial Use Application Method (Non - granular) Concentration (lbs ai/A)

Total Loading to Areas Adjacent to Treated Areas 1 Total Loading to Semi Aquatic Areas Adjacent to Treated Areas 2 Drift to Adjacent Areas 3 Apples (0.11 lb ai/A) Ground Unincorp. 4 0.0066 0.0561 0.0011 Soy bean ( 0.06 lb ai/A) Ground Unincorp. Aerial 0.0036

0.006 0.0306 0.033 0.0006

0.003 1 EEC = Sheet Runoff + Drift (1% for ground; 5% for aerial) 2 EEC = Channelized Runoff + Drift (1% for ground; 5% for aerial) 3 EEC for ground (appl. rate x 1% drift); for aerial (appl. rate x 5% drift) 4 EEC for Unincorporated Ground Spray Application

4. Measures of Incidental Spray Drift Exposure E xposure estimates from spray drift are generated using the AgDRIFT (ver 2.0.1) model, which predicts spray

drift (or ‘acute’) EECs for non
- target terrestrial and aqu atic animals and aquatic plants exposed immediately to the toxicity of the formulat ed product as a whole by incidental application as a result of drift. Exposure modeling for spray drift EECs is limited to situations, as in this case for flutriafol, where available data indicate that the formulat ed product is more toxic to aquatic animals and plants than the technical grade active ingredient
. The limitation on the quantitative exposure modeling for formulations is based on the expectation that the varying phy sical
- chemical properties of individual components of pesticide formulations will result in progressively different formulation constituents in the environmental media over time. As the proportions of formulation components in the environmental media differ from the proportions in the tested formulation, the assumption that environmental residues are toxicologically equivalent to tested formulations cannot be supported beyond the time period44

immediately

following product application. For terrestrial bio ta, exposure modeling is limited to dietary exposure to residues for a time period immediately following product application, while exposure modeling for aquatic biota is limited to direct introduction of the formulation to surface waters immediatel y follo wing application
. Spray drift (or ‘a cute ’) EECs are presented in Table III - 10
. EECs generated from AgDRIFT for the labeled uses of F lutriafol 125 g/L SC on terrestrial outdoor sites are listed in Table III - 9
. These results represent estimates of spray drift concentrations to non - target areas adjacent to treated areas immediately following a single application
. Since the AgDRIFT EECs are used as ‘ acute ’ exposure endpoints in the assessment, no chronic exposure endpoints (from spray

drift or runoff) are available for the formulated product. For agricultural applications, spray

drift was estimated based on the default assumptions that 5% of the application rate of the formulation reaches the adjacent sites for aerial spray and 1% of the application rate for ground spray
. The results for the maximum exposure scenario, appropriate for use in calculating baseline risk quotients, are presented in bold; other values are provided for characterization purposes. Table III - 10 . Spray Drift EECs for the Proposed Flutr iafol 125 g/L SC Uses on Apples and Soybean Calculated by AgDRIFT .

Scenario Application Rate (lbs formulat ed product/A) Application Method

(ground or aerial) Acute EEC from Spray Drift (μg form/L) Apples 0.92 Ground 1.4
Soy beans 0. 5 Ground 0. 77 0. 5 A erial 3.6 C. Ecological Effects Characterization Ecological effects studies have been submitted for flutriafol (technical grade: EPA Reg. No. 4787
- LL) and the flutriafol formulat ed prod uct, F lutriafol 125 g/L SC . In the ecological effects characterization section and in Appendix F , all exposure concentrations and toxicity values are expressed based on the active ingredient (a.i.) and its formulated product (form)
. Following implementation of the Overview document (USEPA, 2004a), EFED has begun incorporating data from open literature into ecological risk assessments (USEPA, 2004b). Toxicity data from open literature are identified via the ECOTOX search engine and maintained by EPA/ORD. Inorder to be included in the ECOTOX database, papers must meet the following minimum criteria:

 the toxic effects are related to a single chemical exposure;  the toxic effects are on an aquatic or terrestrial plant or animal species;  there is a biologic al effect on live, whole organisms;45

 a concurrent environmental chemical concentration/dose or application rate is reported; and  there is an explicit duration of exposure. Data that passes the ECOTOX screen is evaluated along with the registrant
- submitted data, and may be incorporated qualitatively or quantitativel y into the risk assessment. In general, effects data in the open literature that are less than, more conservative than, or surrogates the registrant
submitted data are considered. The degree to which open literature data is quantitatively or qualitatively

characterized is dependant on whether the information is relevant to the assessment endpoints (i.e., maintenance of survival, reproduction, and growth) identified in the problem formulation. Fo r example, endpoints such as behavior modifications are likely to be qualitatively evaluated, because it is unclear whether such modifications cause a reduction in species survival, reproduction, and/or growth. Specific open literature data that are consi dered include the following: (1) the endpoint is more sensitive than those identified in the registrant data; (2) the data is for under represented taxa (i.e., amphibians); (3) the data includes endpoints not normally evaluated in registrant studies, but ecologicall y relevant; and (4) the data surrogates the missing/unavailable registrant data. A search for open literature (ECOTOX) data on flutriafol did not produce any results even though flutriafol has been registered in other countries with previously generated toxi city, effects, and fate studies ; therefore, the data in the risk assessment are based on the studies submitted by the registrant
. A summarized table of toxicity endpoints selected for aquatic and terrestrial risk assessment can be found in Tables IV- 4 , IV- 5 and IV- 12
. 1. Aquatic Effects Characterization a. Aquatic Animals (1) Acute Effects 

### Freshwater Fish, Acute Fish toxicity

studies for two fre shwater species using the technical grade active ingredient (TGAI ) are required to establish the acute toxicity of flutriafol to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish (a warm water fish). Acute studies submitted for the trout and sunfish categorize the TGAI as slightly toxic to freshwater fish on an acute toxicity basis. Results of the acute studies with freshwater fish indicate bluegill sunfish is more sensitive to the TGAI than rainbow trout; therefor e, the sunfish LC 50 value of 33 mg ai/L with the TGAI is used to evaluate potential acute effects of the TGAI to freshwater fish
. In addition, the registrant provided supplement acute studies with these freshwater species using the formulat ed product of flutriafol , Flutriafol 125 g/L SC . The lowest freshwater fish 96
- h L C 50 for Flutriafol 125 g/L SC is 7.9 mg form/L , The study authors suggest the high toxicity of flutriafol in the formulat ed end use product to fish is primarily due to the toxicity

of inerts , not the AI, in the formulation
. The guideline requirement for acute freshwater fish toxicity (MRIDs 470903 10, 47090311 , 47090312 ) , with the exception of the sunfish with Flutriafol 125 g/L SC (MRID46

47090309) , fulfills the OPPTS 850.1075 test guideline for acute toxicity of flutriafol to freshwater fish
. The available freshwater fish toxicity data for flutriafol is discussed below and summarized in Table III - 1 1
. Table III - 1 1 . Freshwater Fish Acute Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC Species % ai 96 - hour LC 50 (m g ai/L) Toxicity

Category MRID No.

Author/Year Study

Classification Flutriafol TGAI Rainbow trout (Oncorhynchus mykiss) 93 52.3 A Slightly toxic 47090311 Hill, R.W. (1982) Acceptable Bluegill sunfish (Lepomis macrochirus) 93 33 B Slightly toxic 47090310 Hill, R.W. (1985) Acceptable Flutriafol 125 g/L SC Rainbow trout (Oncorhynchus mykiss) 11.6 7.9 mg form/L N/A 47090312 Sankey (1993) Acceptable Bluegill sunfish (Lepomis macrochirus) 11.9 20 mg form/L N/A 47090309 Palmer, Sutherland, and Kendall (2007) Supplemental 1
A Trout 95% Confidence Interval = 45.3
- 58.9 mg ai/L; probit slope = N/A (binomial method) B Sunfish 95% Confidence Interval = 23
- 44 mg ai/L; probit slope and 95% C.I. = 4.04 ( 1.99
- 6.09) 1 Do es not satisf

y the OPP guideline requirement for an acute freshwater fish toxicity study with the formulated product, Flutriafol 125 g/L SC, but does provide useful information that suggest the high toxicity of flutriafol in the formulated end use product to fish is primarily due to the toxicity of the formulation inerts, not the active ingredient component of the formulation. Despite the supplemental classification because an EC 50 could not be established for the formulation inerts , the data are considered useful for c haracterizing the aquatic toxicity profile of the formulation inert ingredients relative to the active ingredient (i.e., the formulation ingredients are more toxic to fish than the active ingredient at an amount equal to the highest dose used in the study)
. 

### Aquatic - phase Amphibians No amphibian toxicity

studies were submitted or located in the open literature. Consequentl y, the freshwater fish toxicity

data are used as a surrogate for aquatic
- phase amphibian species, and toxicity between taxa is assumed to be similar. 

### Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the acute toxicity of flutriafol to aquatic invertebrates. The preferred test species is Daphnia magna, a water flea
. Submitted data indicate the TGAI is categorized as no more than slightly to slightly

toxic to Daphnia magna with acute 48
- hour EC 50 s of 67.1 and >63.5 mgai/L ( Table III - 1 2 ). Results of the acute studies with freshwater invertebrates indicate the daphnid E C 50 value of 67.1 mg ai/Lwith the TGAI is used to evaluate potential acute effects of the TGAI to freshwater invertebrates
. In addition, the registrant provided supplement acute toxicity data with Daphnia magna using Flutriafol 125 g/L SC, a flutriafol f ormulat ed product . The 96
- h LC 50 for the formulated product based on immobili ty is 7.05 mg form/L
. Similar to fish, the study authors suggest the greater toxicity of AI in the formulat ed product to invertebrates is primaril y due to the toxicity of inerts ,47

not the AI , in the formulation
. The guideline requirement ( OPPTS 850.1010 ) for acute invertebrate toxicity is fulfilled (MRID s 47090304 , 47090305 ). The available freshwater invertebrate toxicity data is discussed and summarized in Table III - 1 2 , below. Ta ble III - 1 2 . Freshwater Invertebrate Acute Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC Species % ai 48 - hour EC 50 (m g ai/L) Toxicity

Category MRID No.

Author/Year Study

Classification Flutriafol TGAI Water flea (Daphnia magna) 93.0 >63.5 No more than slightly toxic 47090304

Hamer and Hill. 1982. Acceptable 67.1 A Slightly toxic Acceptable Flutriafol 125 g/L SC Water flea ( Daphnia magna ) 11.8 7.05 mg form/L N/A 47090305 Kent, S. 1994. Acceptable A Daphnid 95% Confidence Interval = 58.8
- 78.0 mg ai/L; Probit slope (95% C.I.) = 5.43 ( 3.41
- 7.45) 

### E stuarine/Marine Fish, Acute Acute toxicity

testing with estuarine/marine fish using the TGAI is required for flutriafol because the end
- use product may

be applied directly

to water and/or is expe cted to reach this environment due to its potential use in coastal areas where apples are grown . An acute toxicity study with the TGAI ( Table III - 1 3 ) was performed with the preferred test species, sheepshead minnow. The TGAI 96
- hour LC 50 is > 72.2 mg ai/L, the highest concentration tested, respectively ; therefore, the AI is categorized as no more than slightl y toxic to estuarine/marine fish on an acute basis. No acute toxicity

data with estuarine/marine fish tested with the formulat ed product, Flutriafol 125 g/L , is available. The OPPTS guideline 850.1075 for estuarine/marine fish is fulfilled (MRID 47090308 ). Acute studies with estuarine/marine fish using the formulated product were not submitted ; therefore, the toxicity

of the product itself to estuarine/marine fish from acute exposure to the formulated product ( Flutriafol 125 g/L SC ) is uncertain
. An acute to acute ratio (AAR) value derived from different fish species are used to estimate the acute toxicity value of the product itself to estuarine/marine fish because valid acute L C 50 values are available for calculation (see below)
. The estimated LC 50 is >17 mg form/L. There is uncertainty associated with the estimated LC 50 for the product because the acute toxicity data do not allow for a definitive determination of the relative sensitivity

of freshwater and estuarine/marine fish. 1) Sunfish acute value of the TGAI = 33 mg ai/L = 36 (AAR) Sunfish acute value of the AI in the product 0.92 mg ai/L 2) S heepshead minnow acute value of TGAI = >72.2 mg ai/L = > 2 mg ai/L (estimated acute value of AAR 36 AI in the product) 2a) Sheepshead minnow acute value of formulat ed product = >2 mg ai/L ( estimated) / 11.9% = >17 mg form/L48

The available estuarine/marine fish toxicity data is summarized in Table III - 1 3
.



### Estuarine and Marine Invertebrates, Acute Acute toxicity

testing with estuarine/marine invertebrates using the TGAI is require d for flutriafol because the end
- use product may be applied directly

to water and/or is expected to reach this environment due to its potential use in coastal areas where apples are grown . The preferred test species are mys id shrimp and Eastern o ys ter. S tudies with E astern o ys ter and my sid shrimp show that the TGAI is categorized as slightly toxic to these species ( Table III - 1 4 ) on an acute basis. N o acute toxicity

data with estuarine/marine invertebrates tested with the formulated product are available. Results of the acute studies with estuarine/marine invertebrates indicate mollusk is more sensitive to the TGAI than shrimp; consequently , the TGAI EC 50 value of 25 mg ai/L for Eastern oy ster is used to evaluate potential acute effects of the AI to estuarine/marine invertebrates. The OPPTS guideline s 850.10 2 5 and 850.1035 for mollusks and shrimp are fulfilled (MRIDs 470903 06 and 470903 07 ). Acute studies with the formulated product on estuarine/marine invertebrates were not submitted ; therefore, the acute toxicity values of the AI in its formulated product and the product itself to estuarine/marine invertebrates from acute exposure to the formulated product (Flutriafol 125 g/L SC ) are uncertain
. A cute to acute ratio (AAR) derived from different invertebrate species are employed to estimat e the acute toxicity value of the product itself to estuarine/marine invertebrates because valid acute L C 50 values are available for calculation. Based on calculations (see below) , the estimated EC 50 is 2.5 mg form/L. There is uncertainty associated with the estimated EC 50 of the product for estuarine/marine fish because the acute toxicity data do not allow for a definitive determination of the relative sensitivity of freshwater and estuarine/marine invertebrates. 1) Daphnid acute value of the TGAI = 67.1 mg ai/L = 80 (AAR) Daphnid acute value of the AI in the product 0.83 mg ai/L 2) Oyster acute value of

TGAI = 25 mg ai/L = 0.3 mg ai/L (estimated acute value of AI in the product) AAR 80 2a) Estuarine/marine invertebrate acute value of formulated product = 0.3 mg ai/L ( estimated) / 11.9% = 2.5 mg Table III - 1 3 . Estuarine/Marine Fish Acute Toxicity with Flutriafol TGAI and Flutriafol 1 25 g/L SC Species % ai 96 - hour LC50 (m g ai/L ) Toxicity

Category MRID No.

Author/Year Study Classification Flutriafol TGAI Sheepshead minnow (Cyprinodon variegatus) 95.1 >72.2 * No more than slightly toxic 47090308

Palmer, Sutherland, Kendall, Krueger. 2006. Acceptable Flutriafol 125 g/L SC Estuarine/marine Fish N/A >17 mg form/L N/A AAR N/A * The LC 50 was greater than the highest concentration; therefore, it was not possible to produce a probit slope and 95% confidence intervals. N/A

– Not applica

ble AAR

– Acute to acute ratio using freshwater fish data with TGAI alone and the AI value of the formulated product x 11.9%
.49

form/L ( estimated) The available estuarine/marine invertebrate toxicity data for flutriafol are discussed below and summarized in Table III - 1 4
. Table III - 14 . Estuarine/Mar ine Invertebrate Acute Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC Species % ai. 96 - hour LC 50/EC 50 ( mgai/L) Toxicity

Category MRID No.

Author/Year Study

Classification Flutriafol TGAI Eastern oyster (shell deposition) (Crassostrea virginica) 95.1 E C 50 = 2 5 A Slightly toxic 47090306 Palmer, Sutherland, Kendall, and Krueger. 2006. A cceptable My sid (Americamysis bahia) 95.1 LC 50 = 34.9 B Slightly toxic 47090307 Palmer, Sutherland, Kendall, and Krueger. 2006. Acceptable Flutriafol 125 g/L SC Estuarine/marine Invertebrate N/A 2.5 mg form/L N/A AAR N/A A Oyster 95% Confidence Interval = 17
- 38 mg ai/L; Probit slope (95% C.I.) = 2.14 (0.9

– 3.74 (estimated)) B Mysid 95% Confidence Interval = 30.8
- 47.2 mg ai/L; Probit slope (95% C.I.) = N/A (binomial method). N/A

– Not applicable AAR

– Acute to acute ratio using freshwater invertebrate data with TGAI alone and the AI value of its formulated product. (2) Chronic Effects 

### Freshwater Fish, Chronic A freshwater fish earl y life
- stage test using the TGAI is required to establish the chronic toxicity o f flutriafol to fish. The preferred test species is f athead minnow. EFED will use this TGAI NOAEC value of 4.8 mg ai/L to evaluat e potential chronic effects of the AI to freshwater fish
. The OPPTS 850.1400 guideline is fulfilled (MRID 47090317). The avail able freshwater fish earl y life
- stage toxicity data is discussed below and summarized in Table III - 1 5
. Chronic fish data with the formulat ed product of flutriafol are not available.50

Tabl e III - 1 5 . Freshwater Fish Early Life - Stage Toxicity with Flutriafo l TGAI and Flutriafol 125 g/l SC Species % ai NOAEC (m g ai/L) LOAEC

(m g ai/L) Endpoints

Affected MRID No.

Author/Year Study

Classification Flutriafol TGAI Fathead minnow (Pimephales promelas ) 95.1 4.8 9.5 Larval survival , clinical signs of toxicity, te rminal grow th 47090317

Palmer, Kendall, and Krueger. 2007. acceptable Flutriafol 125 g/L SC Freshwater Fish N/A No Data No Data N/A No Data N/A N/A

– not applicable 

### Freshwater Invertebrate, Chronic A freshwater aquatic invertebrate life
- cycle test u sing the TGAI is required to establish the chronic toxicity of flutriafol to freshwater invertebrates. The preferred test is a 21
- day life cycle on Daphnia magna
. EFED will use the lowest NOAEC of 0.31 mg ai/L to evaluate potential chronic effects of the A I to freshwater invertebrates. In addition, the registrant provided chronic toxicity data with Daphnia magna using the formulat ed product of flutriafol. The NOAEC value of the AI in the formulated product is 0.013 mg ai/L. Again , the study

authors sugges t the greater toxicity of flutriafol in the formulat ed end use product to invertebrates is primarily due to the toxicity

of inerts , not the AI, in the formulation
. The OPPTS guideline 850.1400 is fulfilled for MRID 47090314 but not fulfilled for MRID 4709 0315 and 4709031 6
. The available freshwater invertebrate life cycle data is discussed below and summarized in Table III - 1 6 and Appendix F
. Table III - 1 6 . Freshwater Aquatic Invertebrate Life - Cycle Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC S pecies %

ai NOAEC (m g ai/L) LOAEC

(m g ai/L) Endpoints

Affected MRID No.

Author/Year Study

Classification Flutriafol TGAI Water flea (Daphnia magna) 95.5 0.31 0.55 Length , offspring per adult 47090314

Williams et al . 1990. Acceptable 94.4 1.0 3.2 Adult survival, o ffspring per a dult 47090315 Bätscher. 2004. Supplemental 1 Flutriafol 125 g/L SC Water flea (Daphnia magna) 12.5 0. 1 mg form/L 0. 34 Larval survival, offspring per adult 47090316

Batscher, R. 2004. Supplemental 1 1 Not all test solutions from ea ch treatment level were analyzed. The author reported that only the biologically relevant levels were analyzed. 

### Estuarine and Marine Fish and Invertebrates, Chronic Chronic TGAI studies on estuarine/marine fish and invertebrates were not submitted ; therefore, the toxicity of the TGAI to estuarine/marine species from chronic exposure to flutriafol is uncertain
.51

Therefore, acute to chronic ratios (ACRs) derived from different fish or invertebrate species are employed to estimat e the chronic toxicity of th e TGAI to estuarine/marine fish and invertebrates because valid acute EC 50 and chronic NOAEC values are available for calculation . There is uncertainty associated with the estimated chronic NOAEC for estuarine/marine fish and invertebrates because the acute toxicity data with the TGAI do not allow for a definitive determination of the relative sensitivity of freshwater and estuarine/marine fish or invertebrates. In addition, there are no chronic studies on estuarine/marine fish and invertebrates with the f ormulated product, Flutriafol 125 g/L SC. A fish acute to chronic ratio analy sis was used to determine the estuarine/marine fish chronic value (NOAEC) of the TGAI. The NOAEC is >11 mg ai/L
. 1) Sunfish acute value = 33 mg ai/L = 6.9 Fathead minnow chronic value 4.8 mg ai/L 2) Sheepshead minnow acute value = >72.2 mg ai/L (actual) = >11 mg ai/L (estimated chronic value)

ACR 6.9 An invertebrate acute to chronic ratio anal ys is is used to determine the estuarine/marine invertebrate chronic value (NOAEC) of the TGAI. The NOAEC is 0.16 mg ai/L
.

1) Daphnid acute value = 67.1 mg ai/L = 216 Daphnid chronic value 0.31 mg ai/L 2) Mysid acute value = 34.9 mg ai/L (actual) = 0.16 mg ai/L (estimated chronic value)

ACR 216 There is uncertainty associated with the estimated NOAEC value s of the AI for estuarine/marine organisms because if submitted chronic toxicity data with the product is lower or higher than the estimated value, the toxicity of the AI to estuarine/marine organisms might be under
- or over estimated, respectively
. In summary , when an ACR or a factor e stimated toxicity value is used for risk quotient calculations, this does not replace the data gap and cannot be used to satisfy any OPP guidelines. 7 An ACR analy sis is used as a tool to determine the need for additional testing to address the data gap or uncertainty. (3) Sublethal Effects Sublethal effects observed in the acute aquatic animal studies included loss of equilibrium, lethargy , surfacing , erratic/ceased swimming, quiescence, sounding, dark discoloration, irregular/labored/rapid respiration, coughing, swelling in gut area, and l yi ng on bottom at concentrations higher than observed for mortality or immobilization . In addition to acute studies, the sublethal effects observed in the chronic studies were production of young daphnids b y first generation parents, growth in daphnids and reproduction and growth in fish.

7 EFED memorandum dated June 7 2005, “Use of Acute
- to - Chronic Ratios in Support of Ecological Risk Assessment of Pesticides. ”52 (4) Field Studies No field studies were submitted or identified in the open li terature for use in this assessment.

b. Aquatic Plants A quatic plant toxicity

studies ( Table III - 1 7 ) using the TGAI or TEP are required to establish the toxicity of flutriafol to non
- target aquatic plants. The registrant submitted TEP T ier II testing with five species ; the species are freshwater green alga (Pseudokirchneriella subcapitata) , duckweed (Lemna gibba) , marine diatom (S keletonema costatum) , blue
- green algae (A nabaena flos

- aquae) , and a freshwate r diatom. Of the four non
- vascular species tested with the formulated product (TEP) , the marine diatom is the most sensitive non
- vascular plant. Results with one vascular species and four nonvascular species indicate that non - vascular species are more sen sitive to the formulated product containing flutriafol than vascular species. The 14
- day EC 50 for the vascular plant (duckweed) is 0.78 mg ai/L (EC 05 = 0.018 mg ai/L), based on biomass; and the lowest 4
- day EC 50 for the non
- vascular plant (marine diatom) i s 0.46 mg ai/L (NOAEC = 0.1 mg ai/L), based on biomass. These aquatic plant toxicity studies (MRIDs 47090330, 47090331, 47090332, 47090333, 47090334) are scientifically sound for a formulat ed product ; however, they do not satisfy the OPPTS 850.5400 guideline requirement for a Tier II freshwater alga toxicity study . These studies are classified as supplemental because data were not available to establish an EC 50 for the formulation inerts . However, the studies provide useful information suggesting that the t oxicity of the AI in the formulated product to freshwater vascular plants and algae is primarily due to the formulation inerts, not the active ingredient in the formulation. Despite the supplemental classification because an EC 50 could not be established , the data are considered useful for characterizing the aquatic toxicity profile of the formulation inert ingredients re lative to the active ingredient (i.e., the formulation ingredients are more toxic to fish than the active ingredient at an amount equal t o the highest dose used in the study). The available aquatic plant toxicity studies are discussed below and summarized in Table III - 1 7
.53

Table III - 1 7 . Toxicity of Flutriafol 125 g/L SC (formulat ed product) to Nontarget Aquatic Plants - Tier II

Species % ai EC 50 NOAEC MRID No., Author/Year Study Classification Flutriafol 125 g/L SC Vascular Plant
- Duckweed Lemna gibba 11.9 0.78 mg ai/L (6.6 mg form/L) 0.018 A mg ai/L

(0.15 mg form/L) 47090330

Desjardins, Kendall, and Krueger. 2006. Supplemental 1 N on - Vascular Plant
- marine

diatom Skeletonema costatum 11.9 0.46 mg ai/L (3.4 mg form/L) 0.1 mg ai/L

(0.84 mg form/L) 47090331

Desjardins, Kendall, and Krueger. 2006. Supplemental 1 Non
- Vascular Plant
- freshwater

diatom Navicula pelliculosa 11.9 1.0 mg ai/L 0.35 mg ai/L 47090332 Desjardins, Kendall, and Krueger. 2006. Supplemental 1 Non
- Vascular Plant
- freshwater

green algae Pseudokirchneriella subcapitata 11.9 0.6 mg ai/L 0.24 A mg ai/L 47090333 Desjardins, Kendall, and Krueger. 2007. Supplemental 1 Non
- Vas cular Plant
- f

reshwater blue
- green algae Anabaena flos

- aquae 11.9 14 mg ai/L 2.9 mg ai/L 47090334 Desjardins, Kendall, and Krueger. 2007. Supplemental 1
A Based on the EC 05 because the NOAEC was determined to be lower than the lowest test concentration
. 1 Data were not available to establish an EC50 for the formulation inerts.

2. Terrestrial Effects Characterization a. Terrestrial Animals (1) Acute Effects 

### Birds

– acute oral An acute oral toxicity

study using the technical grade of the active ingredient (TGAI) is required to establish the acute toxicity of flutriafol to birds. T he preferred guideline non - passerine test species is either mallard duck (a waterfowl) or Northern bobwhite quail (an upland game bird) , and a passerine bird
. The registrant submitted data with mallard duck, bobwhite quail , and red
- legged partridge to esta

blish the acute toxicity

of flutriafol TGAI to birds. No data with a passerine bird has been submitted to establish the toxicity of flutriafol TGAI to passerine birds. The submitted acute data indicate that the TGAI is categorized as sli ghtly toxic to upl and game bird s and practicall y non - toxic to waterfowl with oral LD 50 values of 616
- 81 0 and >5000 mg a.i./kg bw, respectivel y ( Table III - 1 8 ). Results of the acute oral studies with birds indicate the red
- legged partridge is more sensitive to the TGAI than the mallard duck and likel y the quail ; therefore, the partridge LD 50 value of 616 mg ai/kg
- bw is used to evaluate potential acute effects of the TGAI to birds via the oral route
. Without data on a passerine bird, the guideline requirement (OPPTS 850.2100 ) is not fulfille d for acute oral toxicity to birds exposed to the TGAI
. The duck (MRID 47090318) and quail (MRID 47471301) studies are classified as acceptable; the partridge study (MRID 47090319) is classified as supplemental because mortality of 5% or m ore occurred during the acclimation period
. The description and classification of the available avian acute oral toxicity data are discussed below and summarized in Table III - 1 8
. No avian acute oral toxicity data with the formulat ed product of flutriafol are available
.54

Table III - 1 8 . Avian Acute Oral Toxicity with Flutriafol TGAI Species % ai LD 50 (mg ai/kg bw) Toxicity

Category MRID No. Author/Year Study Classification Passerine bird No data No data No data No data No data Red
- legged p artridge ( Alectoris rufa) 93 616 A Slightly toxic 47090319

Roberts and Fairley. 1982. Supplemental 1 Mallard duck ( Anas platyrhynchos ) 93 > 5000 B Practically nontoxic 47090318

Roberts and Fairley. 1982. Acceptable Northern bobwhite quail (Colinus virginianus) 95.1 8 1 0 Sl ightly toxic 47471301

Hubbard and Beavers. 2008. Acceptable
A Partridge 95% Confidence Interval = 342
- 1108 mg ai/kg bw ; Probit slope = N/A (binomial method) B A probit slope along with 95% confidence intervals could not be calculated due to lack of a co ncentration
- response relationship. 1 >5% mortality occurred during acclimation 

### Birds

– subacute dietary Two dietary

studies using the TGAI are required to establish the subacute toxicity of flutriafol to birds. The preferred test species are mallard duck (waterfowl) and bobwhite quail (upland game bird). The submitted data indicate the 8
- day acute dietary

L C 50 for duck and quail to be 4062 and 6352 mg ai/kg diet, respectively . Therefore, the TGAI is categorized as slightl y toxic to waterfowl and practically

non - toxic to upland game birds on a subacute dietary basis ( Table III - 1 9 ). Results of the acute dietary

studies with birds indicate the mallard duck is more sensitive to flutriafol TGAI than the bobwhite quail; therefore, the duck LD 50 value of 40 62 mg ai/kg
- diet is used to evaluate potential acute effects of the TGAI to birds via the dietary route . The guideline (OPPTS 850.2200) is fulfilled for a subacute dietary study with birds. The description and classification of the available avian subacut e dietary studies are discussed be low and summarized in Table III - 1 9 and Appendix F
. No avian subacute dietary toxicity data with the formulated product of flutriafol are available
. Table III - 1 9 . Avian Subacute Dietary Toxicity with Flutriafol TGAI Spec ies % ai 10 - Day LC 50 (mg ai/kg - diet) Toxicity

Category MRID No.

Author/Year Study

Classification Northern bobwhite quail (Colinus virginianus) 9 3 6352 A Practically nontoxic 47090321

Roberts. 1986. Acceptable Mallard duck ( Anas platyrhynchos ) 9 3 4062 B Slightly toxic 47090320 Roberts, Fairley, and Al mond. 1982. Acceptable A Quail 95% Confidence Interval = 5240
- 7700 mg ai/kg
- diet; probit slope = N/A (binomial method) B Duck 95% Confidence Interval = 2985
- 5521 mg ai/kg
- diet; probit slope = N/A (binomia l method) 

### Mammals Wild mammal testing is required on a case
- by
- case basis, depending on the results of lower Tier laboratory

mammalian studies, intended use pattern and pertinent environmental fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health Effects Division (HED) substitute for wild mammal testing. These toxicity values are reported55

below in Table III - 20 and summarized in Appendix F
. The results indicate that the TGAI is categorized as moderatel y to slightl y to xic (LD 50 range = 179

– 1480 mg/kg
- bw) to small mammals , while its formulated product is not toxic (LD 50 >2000 mg form/kg) to rat on an acute oral basis. Results of the TGAI acute oral studies with mammal indicate the mouse is more sensitive to flutriafol than the rat; therefore, the mouse TGAI LD 50 value of 179 mg ai/kg
- bw ; as well as, the rat formulat ed product LD 50 value of >2000 mg form/kg
bw , are used to evaluate potential acute effects to mammals
. Table III - 20 . Mammalian Acute Toxicity f or Flutriafol TGAI and Flutriafol 125 g/L SC . Species % ai Test Type LD 50 (mg ai/kg bw) Affected

Endpoints MRID No.

Author, Year Toxicity

Category Flutriafol TGAI
Rat (Sprague
- D awley) 93 acute oral Male = 1140 1 Females = 1480 LD 50 Com

bined > 1000 and < 1500 Mortality 47090335 Slightly toxic

Mouse ( Mus musculus

) Males = 365 2 Females = 179 LD 50 Com

bined not reported Mortality Moderately toxic Flutriafol 125 g/L SC Rat 11.9 acute oral LD 50 Males and Females: >2000 mg form/kg
- bw Mortality 47090003 Practically nontoxic 1 Male (95% Confidence Limits 880
- 1470 mg/kg bw) ; Female (95% Confidence Limits 1090
- 1980 mg/kg bw) 2 Male (95% Confidence Limits 312
- 434 mg/kg bw) ; Female (95% Confidence Limits could not be calculated) 

### Reptiles and Terrestrial - phase Amphibians No amphibian or reptile toxicity studies were submitted or located in the open literature. Consequently , the avian toxicity data are used as a surrogate for ter restrial
- phase amphibian and reptilian species, and toxicity between taxa is assumed to be similar. 

### Beneficial Insects A honey bee acute contact study

using the TGAI is required for flutriafol because its use as a fungicide treatment use will result in ho ney bee exposure ( Table III - 2 1 ). The acute contact LD 50 , using the honey

bee, Apis mellifera , is derived from a laboratory study designed to estimate the quantity of toxicant required to cause 50% mortality in a test population of bees. The contact 48
- h LD 50 is >50 μg ai/bee for the TGAI
. In addition , the registrant provided acute contact studies using the formulat ed product of flutriafol
. The lowest contact 48
- h LD 50 for the formulation is >10.5 μg ai/bee. Results of the acute contact studies with honey bee s indicate the TGAI and formulat ed product of flutriafol are practicall y non - toxic to bees on a contact exposure basis. The guideline (OPPTS 850.3020) is fulfilled. The contact test s (MRID s 47090326 , 47090327 ) are classified as acceptable for the TGAI and formulat ed product of flutriafol
. S upplemental non - guideline56

honey bee acute oral test s with flutriafol and its product were also submitted and are included in the honey bee study
. The description and classification of the available honey bee acute contact an d oral studies are discussed below and summarized in Table III - 2 1 and Appendix F
. Table III - 2 1 . Acute Contact and Oral Toxicity of Flutriafol TGAI and Flutriafol 125 g/L SC to Honeybees Species % ai LD50/LC50 (μg ai/bee) Toxicity

Category* MRID No. Study Classification Flutriafol TGAI Honey be e 93 >50 Practically non
toxic 47090326

McIntosh and Wilkinson. 1982. Acceptable >2 Not categorized Supplemental † Flutriafol 125 g/L SC Honey bee (contact) 12.7 >52.5 Practically non
toxic 47090326

McIntosh and Wilkinson (1982) Acceptable >10.5 Practically non
toxic Acceptable Honey bee (oral ) 47 N/A Supplemental † >50 N/A Supplemental † Honey bee (contact) 12.1 1280 μg/bee or 1% of sucrose Practically nontoxic 47090327 Kleiner, R (1994) Acc eptable Honey bee (oral) >24 N/A Supplemental 1 † Acute oral
- a non - guideline study * The LD 50 s were greater than the highest concentration; therefore, it was not possible to calculate a probit slope and 95% confidence intervals. (2) Chron ic Effects 

### Birds , Reproduction Avian reproduction studies using the TGAI are required to establish the chronic toxicity of flutriafol to birds, especially preceding or during the breeding seaso n ( Table III - 2 2 ) . The preferred test species are mallard duck and bobwhite quail. The data that were submitted show the reproduction NOAEC for duck and quail to be 39.2 and <95.0 mgai/kg diet, respectivel y. Results indicate mallard duck is more sensitive to the TGAI than bo bwhite quail; therefore, the duck NOAEC value of 39.2 mg ai/kg
- diet is used to evaluate potential chronic effects of the TGAI to birds
. The guideline (OPPTS 850.2300) is fulfi lled. The duck study (MRID 47090322) is classified as accep table while the quail study (MRID 47090323) is considered supplemental in the absence of an NOAEC as a result of significant effects at all test levels
. The description and classification of the available avian reproduction studies are discussed below and summarized in57

Table I II - 2 2 and Appendix F
. No avian reproduction toxicity data with the formulated product of flutriafol are available. Table III - 22 . Chronic Toxicity of Flutriafol TGAI to Bobwhite Quail and Mallard Ducks. Species %

a.i. NOAEC (m g ai/kg diet) LOAEC

(m g ai/ kg diet) Affected

endpoints MRID no.

Author/Year Study

classification Northern bobwhite quail (Colinus virginianus) 94.4 <95.0 95.0 Reproduction 47090323 Thompson. 2007. Supplemental 1 Mallard duck ( Anas platyrhynchos ) 95.1 39.2 97.5 Reproduction 47090 322 Tem ple. 2006. Acceptable

1 The ratio of hatchling survival to number of eggs set and 14
- day old survivor weight was adversely affected at all treatment levels ; therefore , a chronic toxicity threshold could not be determined. 

### Mammals, Reproducti on In a 2
- generation reproduction study ( Table III - 2 3 ) with rats exposed to the TGAI , there were no reproductive effects observed for both sexes at concentrations of 0, 60, 240, and 1000 ppm (calculated to be 0, 4.8, 20.6 and 88.7 mg/kg bw/day in parental (P) males; and 0, 5.5, 21.9 an d 103 mg/kg bw day

in P females ). The reproductive LOAEL (Male/Female) is determined to be >1000 ppm ( > 88.7 /> 103 mg ai/kg bw/day), while the parental and offspring LOAEL and NOAEL are both 1000 ppm (88.7/103 mg ai/kg bw/day) and 240 ppm (20.6/21.9 mg ai/kg bw/day) , respectivel y. The lowest NOAEL of 240 ppm and 20.6 mg ai/kg bw/day from this study are used in the risk assessment. The available mammal ian reproduction study is summarized in Table III 2 3 and discussed in Appendix F
. N o mammalian reproduction toxicity data with the formulat ed product of flutriafol are available.

Table III - 2 3 . Mammalian Reproductive Toxicity for Flutriafol TGAI . Species % ai Test

Type Toxicity ppm (mg/kg bw/day) Affected Endpoints MRID No.

Study author Classification

Rat (Sprague Dawley) 93 2
- generation Parental NOAEL = 240 (20.6 in P males; 21.9 in P females) LOAEL = 1000 (88.7 in P males; 103 in P female s) decreased body weight gains, food consumption, effects on liver 47090351 Reproductive NOAEL = 1000 (88.7

– 103)

LOAEL >1000 None Offspring NOAEL = 240 (20.6 in P males;

21.9 in P females) LOAEL = 1000 (88.7 in P males; 103 in P females) decreas ed live birth index and litter size, effects on liver58 (3) Sub - lethal Effects In the acute s tudies with birds and mammals, s ublethal effects observed included subdued behavior, weakness, squatti ng, prostration, unsteadiness, body weight, food consumption, clinical signs of toxicity, pale/blotchy livers , and l yi ng on floor at levels higher than for mortality
. In addition to acute studies, the sublethal effects observed in the chronic studies with birds were eggs laid per female , eggs set per female, shell thickness, viable embryos, % viable embryos of eggs set, l ive 3
- week embryos , % live 3
- week embryos of viable embryos , % normal hatchlings, % normal hatchlings of eggs laid , % normal hatchlings of eggs set , % normal hatchlings o f live 3
- week embryos, % hatchling survival % 14
- day survivors , % 14
- day

survivors of eggs set , maternal body weight , and survivor body weight. The sublethal effects observed in the rat reproduction study were body weight g ains, food consumption, effects on liver, live birth index, and litter size. The observed sub
- lethal effects in these chronic studies with birds and mammals occurred at levels higher than or equal to the NOAEC. (4) Field Studies Data were not available to evaluate population recovery , age - class strengths, or shifts in species composition of terrestrial animals when exposed to flutriafol
.

b. Terrestrial Plants Terrestrial plant studies are required for all terrestrial outdoor pesticides. T errestrial plant toxicity studies were conducted to establish the toxicity of flutriafol formulat ed product at the maximum dose to non - target terrestrial plants. The recommendations for seedling emergence and vegetative vigor studies are for testing of (1) six species of at least four dicotyl edonous families, one species of which is soy

bean ( Glycine max), and the second of which is a root crop, and (2) four species of at least two monocotyledonous families, one of which is corn (Zea mays ). Results with monocots and dicots indicate that seedling emergence and vegetative vigor were not inhibit ed by 25% or more via exposure to the flutriafol formulation at 0.12 lb ai/A. Even though 25% inhibition was not evident in the studies, a statistically significant reduction of dry weight (ryegrass) in the vegetative vigor study was observed ; resulting in the need for a tier II study with ryegrass . After reviewing all studies, the s eedling emergence NOAEC is > 0.12 lb ai/A (MRID 47090328) ; and the vegetative vigor NOAEC is ≥0.12 lb ai/A (MRIDs 47090329 and 47689801)
. The three studies are acceptable and fulfill the guideline s ( OPPTS 850.4100 and 850.4150)
. The description and classifi cation of the available terrestrial plants studies are discussed below and summarized in Table s III - 2 4 , III - 2 5 , and III - 2 6
. 

### Seedling Emergence Table III - 2 4 . Summary of Tier I Seedling Emergence Results for Flutriafol 125 g/L SC * Species Most sensitive

endpoint %

Inhibition t - Test 1

(p - value) Significant

Effect ? (yes or no) MRID

Author/Year Study

Classification Corn Length 4.8 n/a No 47090328 Porch, Acceptable Onion Dry

w eight 6.9 0.63 No59

Ryegrass Emergence 8.8 0.23 No Martin, and Krueger. 2006. Wheat Length 1.6 n/a No Cabbage Dry

w eight 6.1 0.42 No Lettuce Dry

w eight 6.8 0.44 No Radish Length 2.8 n/a No Soy bean Dry

w eight 9.0 0.32 No Sugar beet Emergence 3.2 n/a No Tomato None 0.0 n/a No * 11.9% flutriafol, tested at the maximum application rate of 0.12 lb ai/A 1 A t
- test is required when any endpoint exhibits > 5% inhibition at the maximum dose when compared to negative control. For any endpoint with less than 5% inhibition, a t
- test is not required. 2 A p - value of 0.05 or smaller indicates a signifi cant effect at the maximum dose
. 

### Vegetative Vigor Table III - 25 . Summary of Tier I Vegetative Vigor Results for Flutriafol 125 g/L SC * Species Most sensitive

endpoint %

Inhibition t - Test 1

(p - value) Significant

Effect ? (yes or no) MRID

Author/Year Study

Classification Corn Length 0.9 n/a No 47090329 Porch, Martin, and Krueger. 2006. Acceptable Onion None
- 4.2 n/a No Ryegrass Dry

w eight 17.1 0.009 Yes Wheat Length 0.9 n/a No Cabbage None
- 6.5 n/a No Lettuce None
- 4.5 n/a No Radish Dry

w eight 6.7 0.22 No Soy bean Dry

w eight 1.8 n/a No Sugar beet Dry

w eight 15.1 0.32 No Tomato None
- 6.0 n/a No * 11.9% flutriafol, tested at the maximum application rate of 0.12 lb ai/A 1 A t
- test is required when any en dpoint exhibits > 5% inhibition at the maximum dose when compared to negative control. For any endpoint with less than 5% inhibition, a t
- test is not required. 2 A p - value of 0.05 or smaller indicates a significant effect at the maximum dose
. Table III - 2 6 . Summary of Tier II Vegetative Vigor Results for Flutriafol 125 g/L SC with Ryegrass* Species EC50

(lb ai/A) EC25

( lb ai/A) N OAEC

( lb ai/A) Affected

endpoints MRID no.

Author/Year Study

classification Ryegrass >0.26 >0.26 0.26 None 47689801 Porch, Martin, and Krueger. 2009. Acceptable * 11.9% flutriafol, tested at the maximum application rate of 0. 26 lb ai/A IV. RISK CHARACTERIZATION Risk characterization provides the final step in the risk assessment process. In this step, exposure and effects characterization are integrated to provide an estimate of risk relative to OPP’s established levels of concern (LOCs). The results are then interpreted for the risk manager through a risk description and s ynth esized into an overall conclusion.60

A. Risk Estimation - Integration of Exposure and Effects Data A deterministic approach is used to evaluate the likelihood of adverse ecological effects to non
target species. In this approach, risk quotients (RQs) ar e calculated b y dividing exposure estimates (EECs) by

ecotoxicity

values for non
- target species, both acute and chronic.

RQ = EXPOSURE/TOXICITY RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used b y OPP to indicate potential risk to non
- target wildlife and the need to consider regulatory action. Exceedance of the LOC by the RQ indicate s that a pesticide used as directed has the potential to cause adverse effects on non
- target wildlife. LOCs currentl y address the fo llowing risk presumption categories: (1) acute risk
- potential for acute risk to non
- target animals which may warrant regulatory

action in addition to restricted use classification, (2) acute restricted use

– potential for acute risk to non
- target animals , but may be mitigated through restricted use classification, (3) acute endangered species

– endangered species may be potentially

affected by use, (4) chronic risk

– potential for chronic risk may warrant regulatory

action, endangered species may

potentially

be affected through chronic exposure, (5) non - listed plant risk
- potential for effects in non
- target (non
- listed) plants, and (6) listed plant risk

– potential for effects in listed plants. Currently , EFED does not perform baseline assessments for c hronic risk to plants or acute or chronic risks to non
- target insects. For acute studies on taxa where no effects were observed at any concentration level, the RQ is not calculated. For acute studies on taxa where an LC/LD 50 is not established due to ins ufficient mortality but reported some mortality in the study, an RQ is not calculated , and the study is discussed further in the Risk Description section. Risk presumptions, along with the corresponding RQs and LOCs are tabulated below in Tables IV- 1, - 2, and - 3 :61 Table IV- 1. Risk

Presumptions for Terrestrial Animals Risk Presumption RQ LOC Birds : Acute Risk EEC 1 /LC 50 or LD 50/sqft2 or LD 50 /day3 ≥ 0.5 Acute Restricted Use EEC/LC 50 or LD 50/sqft or LD 50/day (or LD 50 < 50 mg ai/kg) ≥ 0.2 Endangered Species EEC/LC 50 or LD 50/sqft or LD 50/day ≥ 0.1 Chronic Risk EEC/NOAEC ≥ 1 Wild Mammals : Acute Risk EEC/LC 50 or LD 50/sqft or LD 50/day ≥ 0.5 Acute Restric ted Use EEC/LC 50 or LD 50/sqft or LD 50/day (or LD 50 < 50 mg ai/kg) ≥ 0.2 Endangered Species EEC/LC 50 or LD 50/sqft or LD 50/day ≥ 0.1 Chronic Risk EEC/NOAEC ≥ 1 Invertebrates: Endangered Species EEC/LD 50 ≥ 0. 05
1 EEC=abbreviation for Estimated Environmental Concentration (mg ai/kg) on avian/mammalian food items 2 mg/ ft 3 mg of toxicant consumed/day LD 50 * wt. of bird LD 50 * wt. of bird Table IV- 2. Risk

Presumptions for Aquatic Animals Risk Presumption RQ LOC Acute Risk EEC 1 /LC 50 or EC 50 ≥ 0.5 Acute Restricted Use EEC/LC 50 or EC 50 ≥ 0.1 Acute Endangered Species EEC/LC 50 or EC 50 ≥ 0.05 Chronic Risk EEC/NOAEC ≥ 1 1 EEC = (mg ai/L or μg ai/L) in water Table IV - 3. Risk Presumptions for Plants Risk Presumption RQ LOC

Terrestrial Plants in Terrestrial and Semi-Aquatic Areas: Non
- Listed Species EEC 1 /EC 25 ≥ 1 Listed Species EEC/NOAEC or EC 05 3 ≥ 1 Aquatic Plants: Non
- Listed Species EEC 2/EC 50 ≥ 1 Listed Species EEC/NOAEC or EC 05 3 ≥ 1 1 E EC = lbs ai/acre 2 EEC = (μg ai/L or mg ai/L) in water 3 An EC 05 is only used when a definitive NOAEC is not available.62

The following section presents the acute and chronic risk quotients calculated for flutriafol and its formulated product and the L OCs (if any) that are exceeded. Further discussion of the risk quotients and uncertainties in the assessment is presented in Section IV and Appendices C , D, and E
. 1. Non - target Aquatic Animals and Plants For this baseline risk ass essment with aquatic animals and plants , acute and chronic RQs are derived based on ecological toxicity data for both the AIalone and its formulated product , Flutriafol 125 g/L SC, and then compared to the EECs generated from GENEEC2 , PRZM/EXAMs, and AgDRIFT
. For this assessment, acute and chronic risks to aquatic animals exposed to the AIalone are calculated b y comparing the acute and chronic toxicity values of the AIalone to GENEEC EECs, while the risks for aquatic animals exposed to the formulated pro duct are calculated b y dividing the acute toxicity value of the product itself (mg form/L) by AgDRIFT EECs. The risks for aquatic plants adjacent to soy bean sites exposed to flutriafol are calculated b y comparing the toxicity

values of the AI in its formul ated product to GENEEC EECs , while the risks for aquatic plants adjacent to apple sites are compared with PRZM/EXAMs EECs
. Table IV- 4 presents the toxicity endpoint values used to calculate acute and chronic risk quotients ( RQs ) and estimate risk to aquatic receptors from exposure through spray drift and surface runoff/leaching with GENEEC2 EECs ( Table III - 5 ) or PRZM/EXAMS EECs ( Table III - 7 )
. Details of the acute and chronic EEC calculations for aquatic animals and plants are provided in Section III.2
. The potential risk s to aquatic animals and plants are described further in the Risk Description section.63

Table IV - 4 . Flutriafol TGAI Toxicity Endpoint Values for Assessing Risk to Aquatic Animals and Plants Exposure Scenario Species Exposure Duration To xicity Endpoint

Value Endpoint Reference (Classification) Freshwater Fish Ac ute Bluegill sunfish

Lepomis macrochirus 96 hour LC 50 = 33 mg ai/L Survival MRID 47090310 (Acceptable) Chronic Fathead minnow

Pimephales promelas Early Life Stage NOAEC = 4.8 mg ai/L Survival and Grow th MRID 47090317

(Acceptable) Freshwater Invertebrates Ac ute Water flea

Daphnia magna 48 hour EC 50 = 67 .1 mg ai/L Immobility MRID 47090304 (Acceptable) Chronic Life
- cycle NOAEC = 0.31 mg ai/L Grow th MRID 47090314

(Acceptable) Es tuarine/Marine Fish Ac ute Sheepshead minnow

Cyprinodon variegatus 96 hour LC 50 >72.2 mg ai/L Survival MRID 47090308 (Acceptable) Chronic NOAEC = > 11 mg ai/L 1 Ac ute to Chronic Ratio Estuarine/Marine Invertebrates Ac ute Eastern oyster

Crassostrea virginia (shell deposition) 96 hour EC 50 = 25 mg ai/L Grow th MRID 47090306

(Acceptable) Chronic NOAEC = 0.16 mg ai/L 2 Ac ute to Chronic Ratio 1 Estimated using an acute to chronic ratio (ACR) as follows: Sheepshead minnow LC 50 x minnow NOAEC  sunfish LC 50 = estimated estuarine/marine fish NOAEC 2 Estimated using an acute to chronic ratio (ACR) as follows: My sid EC 50 x daphnid NOAEC  daphnid EC 50 = estimated estuarine/marine invertebrate NOAEC In addition to aquatic toxicity studies for the active ingre dient, Table IV- 5 presents the toxicity endpoint values of the registrant
- submitted studies on Flutriafol 125 g/L SC, the formulat ed product containing 11.9% active ingredient flutriafol. The formulated product tested is the same product proposed f

or regis tration as a formulated product of the new chemical. These toxicity endpoint values are used to further assess the risks to fish and invertebrates from the formulated product because of concerns that the toxicity of the formulat ed product is significantly more toxic than the active ingredient alone
. Therefore, the risks to the formulated product must be assessed rather than to just the active ingredient alone
. B ased on available formulation data, it appears that the enhanced toxicity

of the formulation is d

ue to the presence of the inert ingredient (s) within the formulatio n, rather than the AI.64

Table IV - 5 . Flutriafol 125 g/L SC Toxicity Endpoint Values for Assessing Risk to Aquatic Animals Exposure Scenario Species Exposure Duration Toxicity Endpo int Value Endpoint Reference (Classification) Freshwater Fish Ac ute Bluegill sunfish

Lepomis macrochirus 96 hour LC 50 = 7.9 mg form/L Survival MRID 4709031 2 (Acceptable) Estuarine/marine Fish Ac ute LC 50 = >17 mg form/L 1 AAR Freshwater Invertebrates Ac ute Water flea

Daphnia magna 48 hour EC 50 = 0.83 mg ai/L (7.05 mg form/L) Immobility MRID 47090305 (Acceptable) Estuarine/marine Invertebrates Ac ute EC 50 = 2.5 mg form/L 2 AAR Aquatic Plants
Nonvascular Marine diatom

Skeletonema costatum 96
- hour EC 50 = 0.46 mg ai/L ; (3.9 mg form/L) NOAEC = 0.1 mg ai/L ; (0.84 mg form/L) Grow th MRID 47090331

( Supplemental 4 )
Vascular Duckweed

Lemna gibba 7day EC 50 = 0.78 mg ai/L ; (6.6 mg form/L) EC 05 = 0.018 mg ai/L 3 ; (0.15 mg form/L) Grow th MRID 47090330

(Supple me ntal 4 )
1 Estimated using an acute to acute ratio (AAR) as follows: Sheepshead minnow LC 50 of AI value in product x sunfish LC 50 of AI value in product  sunfish LC 50 of the TGAI = estimated estuarine/marine fish LC 50 of the AI in its formulated product x 11.9% = estimated estuarine/marine fish LC 50 of the product
. 2 Estimated using an acute to acute ratio (AAR) as follows: Oyster EC 50 of AI value in product x daphnid EC 50 of AI value in product  daphnid LC 50 of the TGAI = estimated estuarine/marine invertebrate LC 50 of the AI in its formulated product x 11.9% AI = estimated estuarine/marine invertebrate LC 50 of the product. 3 With inhibition observed at all treatment levels, the NOAEC is determined to be below the lowest treatment level. The surroga te EC 05 is used in the absence of a NOAEC to calculate the risks to endangered aquatic nonvascular plants. 4 Data were not available to establish a dose
- response curve for the formulation inerts
. AAR

– acute to acute ratio

a. Fish A cute Risk Quotients of the AI alone For the apple use scenario with the TGAI , the acute RQ of <0.01 does not exceed the acute endangered LOC of 0.05 for freshwater fish , therefore, there are no acute LOC exceedances for the soy bean use scenarios because the EECs /RQs are lower than the apple scenario
. A definitive acute toxicity threshold was not established for estuarine/marine fish (acute LC 50 > 72.2 mg ai/L), RQs are not quantitativel y estimated
. The results for freshwater fish are provided in Table IV- 6
.65

Table IV - 6 . Flutriafol Acute Risk Quotients for Freshwater Fish Based On a Bluegill Sunfish LC 50 of 33 m g ai/L and for Estuarine/m arine Fish Based on a Sheepshead Minnow LC 50 of >72.2 mg ai/L. Site / Application Method / Rate in lbs ai/A (No. of Apps.) Sunfish LC50 (m g ai/L) Minnow

LC50 (m g ai/L) Peak

GENEEC EEC ( m g ai/L) F reshwater F ish

Acute RQ (EEC/ Sunfish LC50) Estuarine/marine

F ish Acute RQ (EEC/ Minnow LC50) Apples / ground 0.11 ( 4 ) 33 >72.2 0. 0 21 < 0.01 RQ not estimated Acute Risk Quotients of the Formulated Product itself Using AgDRIFT EECs f

rom the soy

bean aerial scenarios with the toxicity value for the formulat ed product itself

, the acute RQ of <0.01 does not exceed the acute endangered species LOC of 0.05 for freshwater fish. Thus, no acute LOC exceedances for the apple ground and soy bean ground scenarios because the RQ s are lower than the soybean aerial scenario s . There is a potential for acute exposure to estuarine/marine fish from the product , but acute risks are not quantitativel y estimated because toxicity information on the formulat ed product, Flutriafol 125 g/L SC, was not established (estimated acute LC 50 >17 mg form/L) and will be discussed qualitatively

in the Risk Description section
. The results for freshwater fish are provided in Table IV- 7
. Table IV - 7 . Flutriafol 125 g/L SC Formulat ed Product Acute Risk Quotients for Freshwater Fish Based On a Sunfish LC 50 of 0.92 mgai/L and 7.9 m g form/L Site / Application Method Sunfish LC50 (m g ai/L) Sunfish

LC50 (m g form/L) Peak

GENEEC EEC (m g ai/L) AgDRIFT

EEC 1 (m g form/L) Acute RQ

(EEC/ TGAI) Acute RQ

(EEC/ FORM) soy bean / aerial N/A 7.9 N/A 0.0036 N/A <0.01 apple / ground 0.92 N/A 0.021 N/A 0.035 N/A
1 Based on acute EECs (Table III
- 4) from spray drift alo ne, excluding runoff assumptions. Chronic Risk Quotients of the AI alone For the proposed uses of the AI alone , the chronic risk L OC is not exceeded for freshwater fish from multiple applications . Using the highest estimated GENEEC EEC for the ground spray to apple scenario/lowest NOAEC combination (60
- day EEC value of 0. 0 2 1 mg ai/L) and the corresponding chronic NOAEC (4.8 mg ai/Lfor freshwater fish), the highest chronic RQ is <0.01 , which is below the chronic risk LOC of 1
. C hronic RQs for freshwater f ish based on the other use scenarios including ground and aerial application to soy beans are also less than the LOC
. Therefore, an RQ summary table for chronic exposure of flutriafol TGAI to freshwater fish is not provided. N o chronic toxicity data for the AI alone with estuarine/marine fish is available , a fish acute to chronic ratio was used to estimate the estuarine/marine fish chronic value (NOAEC) of >11 mg ai/L
. The estimated NOAEC value of >11 mg ai/L is not a definitive chronic toxicity threshold for66

estuarine/marine fish exposed to the AI alone ; thus , chronic RQs for estuarine/marine fish are not quantitatively

estimated
. b. Invertebrates Acute Risk Quotients of the AI alone Based on the most conservative exposure scenario (apple) for the AI alo ne , the acute RQ s of <0.1 do not exceed the acute listed species LOC of 0.05 for freshwater and estuarine/marine invertebrates . All other acute RQs for both freshwater and estuarine/marine invertebrates are less than 0.01 for all other scenarios. The results for freshwater and estuarine/marine invertebrates exposed to the AI alone are provided in Table IV- 8
. Table IV - 8 . Flutriafol Acute Risk Quotients for Invertebrates Based On a Daphnid EC 50 of 67 m g ai/L and for Estuarine/marine Invertebrates Based on an Eastern oyster EC 50 of 25 m g ai/L . Site/ Application Method/ Rate in lbs ai/A (No. of Apps.) Daphnid

E C50 ( mgai/L ) Oyster

EC50 (m g ai/L) Peak

GENEEC EEC (m g ai/L) FW Invertebrates

Acute RQ (EEC/ Daphnid E C50) E/M Invertebrates

Acute RQ (EEC/ Oyster EC50 ) Apples / ground 0.11 ( 4 ) 67 25 0.021 <0.01 < 0.01 Acute Risk Quotients of the Formulated Product itself Based on the most conservative exposure scenario ( soy bean aerial ) for Flutriafol 125 g/L SC , the acute RQs of <0.01 do not exceed th e acute endangered species LOC of 0.05 for freshwater and estuarine/marine invertebrates exposed to the formulated product itself . All other spray

drift RQs for both freshwater and estuarine/marine invertebrates are less than 0.01 for all other scenarios
. The results are provided in Table IV- 9
. Table IV - 9. Flutriafol 125 g/L SC Formulat ed Product Acute Risk Quotients for Invertebrates Based On a Daphnid EC 50 of 7.05 m g form/L and Estuarine/marine Invertebrate LC 50 of 2.5 m g form/L
Site/ Application Me thod Daphnid E C50 ( mg form/L ) E/M

Invertebrate E C50 ( mgform/L ) AgDRIFT

E EC 1 (m g form/L) FW Inv.

Acute RQ (EEC/ FORM ) E/M Inv.

Acute RQ (EEC/ FORM ) Soy bean / aerial 7.05 2.5 0.0036 <0.01 <0.01 1 Based on acute EECs from spray drift alone, excluding runoff assumptions. Chronic Risk Quotients of the AI alone Based on available toxicity data of the AI alone and flutriafol application in apple and so ybean sites, the chronic risk LOC is not exceeded for freshwater invertebrates
. Using the estimated E EC for the standard pond scenario/NOAEC combination (21
- day EEC value of 0. 0 2 1 mg ai/L for ground application to apples ) and the corresponding chronic NOAEC (0.31 mg ai/L for freshwater invertebrates ), the chronic RQ is 0. 068 , which is well below the chronic risk L OC of 1
. RQs for the other scenarios are not expected to exceed the chronic LOC because EECs from the se exposure67

scenarios are lower than the most conservative scenario. Therefore, an RQ summary table is not provided. N o chronic toxicity

data f or the AI alone with estuarine/marine invertebrates was available to estimate a chronic NOAEC value, an invertebrate acute to chronic ratio analysis was used to determine the estuarin e/marine invertebrate chronic value (NOAEC) of 0.16 mg ai/L
.

1) Daphnid acute value = 67 .1 mg ai/L = 216 (ACR) Daphnid chronic value 0.31 mg ai/L 2) Mysid acute value = 34.9 mg ai/L (actual) = 0.16 mg ai/L (estimated chronic value)

ACR 216 3) 21
- day EEC/Mysid chronic value = 0.03 2 (actual) = 0. 2 (RQ) 0.16 mg ai/L (estimated chronic value) Assuming an estimated NOAEC value of 0.16 mg ai/L for e stuarine/marine invertebrates exposed to the AIalone , the chronic RQ of 0.2 does not exceed the chronic risk and endangered species LOC of 1. Therefore, i t is un likely that the chronic LOC would be exceeded for estuarine/marine invertebrates when exposed to the AI onl y .

c. Aquatic Plants There is a potential for exposure of the active ingredient to aquatic vascula r and nonvascular plant species. T oxicity

data with the ty

pical end
- use product are used to estimate the risks of the AI in its product t o aquatic plants as a result of runoff and drift , while the risks to the formulation itself for aquatic plants are based on spray drift onl y . (1) Non - listed Plants Non
- listed Plant Risk Quotients ofAI in its Formulated Product The toxicity

value o f the AI in its formulated product with peak GENEEC EEC of all scenarios does not exceed the non
- listed plant L OC of 1.0 for aquatic vascular and non
- vascular plant s . Res ults are provided in Table IV- 1 0
. Table IV - 1 0 . Flutriafol 125 g/L SC Formulat ed Prod uct Risk Quotients for Non - listed Aquatic Plants Based On a Duckweed EC50 of 0.78 m g ai/L and a Diatom EC50 of 0.46 m g ai/L 1 Scenario Peak GENEEC EEC (m g ai/L) Toxicity Non - Listed Plant RQs

Vascular Non - Vascular Vascular Non - V ascular Ground Spray to A

pples (0.11 lb ai/A x 4 apps x 7D intervals) 0.021 0.78 0.46 0.0 3 0.0 5 1 Detailed calculations for GENEEC EECs are provided in Section III.268

Non
- listed Plant Risk Quotients of the Flutriafol Formulated Product itself For the total toxicity

of the formulat ed product with AgDRIFT EECs , there are no exceedances of the non
- listed LOC for both vascular and non
- vascular plants exposed to spray drift via ground spray to apples and from ground/aerial spray to soy beans . Results are provided in T able IV- 1 2
. Tab le IV - 1 1 . Flutriafol 125 g/L SC Formulat ed Product Risk Quotients for Non - listed Aquatic Plants Based On a Duckweed EC50 of 6.6 m g form/L and a DiatomEC50 of 3.9 m g form/L 1 Scenario AgDRIFT EEC (m g form/L) Toxicity (m g form/L) Non - Listed Plant RQs

V ascular Non - Vascular Vascular Non - V ascular Aerial Spray to Soy

beans (0. 5 lb form

/A x 3 apps x 7D intervals) 0.0036 0.78 0.46 <0.1 0.03 1 Detailed calculations for acute EECs are provided in Section III.4
.

(2) Listed Plants Listed Plant Risk Quotien ts of the AI in its Formulated Product
a. Risk Quotients for Listed Aquatic Plants Adjacent Soybean Sites The toxicity

value of the AI in its formulated product with peak GENEEC EEC do not exceed the listed plant L OC of 1.0 for aquatic vascular and nonv ascular plants adjacent to treated so ybean sites. Results are provided in Table IV- 1 2
. Table IV - 1 2 . Flutriafol 125 g/L SC Formulat ed Product Risk Quotients for Listed Aquatic Plants Based On a Surrogate Duckweed EC05 of 0.018 m g ai/L and a DiatomNOAEC o f 0.1 m g ai/L 1 Scenario Peak GENEEC EEC (m g ai/L) Toxicity Listed Plant RQs

Vascular Non - Vascular Vascular Non - V ascular Ground Spray to Soybeans (0.6 lb ai/A x 3 apps x 14D intervals) 0.0086 0.018 0.1 0.5 <0.1 Aerial Spray to Soybeans (0.6 lb ai/A x 3 apps x 14D intervals) 0.01 0.018 0.1 0.6 <0.1 Ground Spray to Soybeans (0.6 lb ai/A x 3 apps x 21D intervals) 0.0087 0.018 0.1 0.5 <0.1 Aerial Spray to Soybeans (0.6 lb ai/A x 3 apps x 21D intervals) 0.009 0.018 0. 1 0.5 <0.1
* Bold value indicate LOC exceedance (*exceeds the listed plant LOC of 1) A EC 05 is used in absence of NOAEC 1 Detailed calculations for GENEEC EEC s are provided in Section III.2. b. Risk Quotients for Listed Aquatic Plants Adjacent Apple Sites69

When the toxicity

value s of the AI in its product are compared with tier II PRZM/EXAMs EECs for apple use in different geographical locations , the refined RQ s do not exceed the listed plant LOC of 1.0 for both aquatic vascular and nonvascular plants adjacent to treated apple fields. Thus, there are no LOC exceedances for aquatic plants adjacent apple and soy bean fields. Results are provided in Table IV- 12a
. Table IV - 12a . Flutriafol 125 g/L SC Formulated Product Risk Quotients for Listed Aquatic Plants Based On a Surrogate Duckweed EC05 of 0.018 m g ai/L and a DiatomNOAEC of 0.1 m g ai/L 1,2 Scenario Peak PRZM/EXAMs EEC (m g ai/L) Toxicity Listed Plant RQs

Vascular Non - Vascular Vascular Non - V ascular NC Apples 0.01 0.018 A 0.1 0.6 0.1 OR Apples 0.003 0.018 0.1 0. 2 <0.1 PA Apples 0.006 0.01 8 0.1 0.3 <0.1 * Bold value s indicate LOC exceedance (*exceeds the listed plant LOC of 1) A EC 05 is used in absence of NOAEC 1 Detailed calculations for GENEEC EEC s are provided in Section III.2. 2 Ground Spray to Apples (0.11 lb ai/A x 4 apps x 7D interv als) Listed Plant Risk Quotients of the Flutriafol Formulated Product itself Based on available toxicity data f or F lutriafol 125 g/L SC itself and AgDRIFT EECs , there are no exceedance s of the listed plant LOC for vascular and nonvascular aquatic plants receiving exposure via spray

drift alone from adjacent treated soy bean sites ( Table IV- 1 3 ). All other RQs for listed plants are less than 1.0 for all other scenarios
. Table IV - 1 3 . Flutriafol 125 g/L SC Formulat ed Product Risk Quotients for Listed Aquatic Plants Based On a Surrogate Duckweed EC 0 5 of 0. 15 mg form/L and a DiatomNOAEC of 0. 84 mg form/L 1,2 Scenario AgDRIFT EEC (m g form/L) Toxicity Listed Plant RQs

Vascular Non - Vascular Vascular Non - V ascular Aerial Spray to Soy

beans (0. 5 lb form

/A x 3 app s x 7D intervals) 0.0036 0.15 A 0. 84 <0.1 <0.1
A EC 05 is used in absence of NOAEC 1 Detailed calculations for acute EECs are provided in Section III.4
.

d. Aquatic - phase Amphibians and Reptiles EFED currentl y uses surrogate data (freshwater fish) for aquatic
- phase amphibians. Risks are qualitatively

discussed in the Risk Description section. 2. Non - target Terrestrial Animals For this baseline risk assessment with terrestrial animals, acute and chronic RQs are derived based on ecological toxicity

data for both the AI alone and its formulated product, Flutriafol 125 g/L SC, and then compared to the EECs generated from T
- REX and AgDRIFT. Acute and chronic RQs for70

terrestrial animals exposed to the AI alone are calculated by comparing the acute and chro nic toxicity values of the AI alone to T
- REX EECs
. Acute RQs for the product itself are calculated b y dividing the acute toxicity value of the flutriafol formulat ed product itself to AgDRIFT EECs. Table s IV- 1 4 and IV- 1 5 present the AI alone and its formul ated product toxicity endpoint values , respectivel y, used to calculate RQs and estimate risk to terrestrial receptors from flutriafol residues as a result of direct deposition and spray drift from broadcast applications. Details of the RQ calculations for terrestrial animals are provided below and in Appendix D
. The potential risk s to terrestrial animals are described further in the Risk Description section.
Table IV - 1 4 . Flutriafol Toxicity Endpoint Values for Assessing Risk t o Terrestrial Anim als Exp osure Scenario Species Exposure Duration Toxicity Endpoint

Value Endpoint Reference (Classification) Mam mal Ac ute Oral Laboratory

mo use (20 g) Single Oral

Dose LD 50 Females = 179 mg

ai/kg bw Survival MRID 47090335 (Acceptable) Chronic Reproduction Lab oratory rat 2
- generation NOAEC = 240 mg ai/kg
diet (20.6 mg ai/kg bw /day in P 1 males ). Parental and

offspring toxicity MRID 47090351

(Acceptable) Birds
Ac ute Oral Red
- legged

Partridge ( 430g ) Alectoris rufa Single Oral

Dose LD 50 = 616 mg ai/kg bw None MRI D 47090319 (Acceptable) Subacute Dietary Mallard duck

Anas platyrhynchos 8 days LC 50 = 4062 mg ai/kg
diet None MRID 47090320 (Acceptable)

Chronic Mallard duck

Anas platyrhynchos one

generation NOAEC = 39.2 mg

ai/kg
- diet Reproduction (percentage of hatch lings of live 3
- week embryos, percentage of hatchling of eggs set, 14
- day survivors, and number of hatchling) MRID 47090322

(Acceptable)

Insects Ac ute Contact Honey Bee

Apis mellifera 96 hour LD 50 > 50 μg ai/bee None MRID 47090326 (Acceptable)71

Table IV - 1 5 . Flutriafol 125 g/L SC Toxicity Endpoint Values for Assessing Risk t o Terrestrial Animals Exposure Scenario Species Exposure Duration Toxicity Endpoint

Value Endpoint Reference (Classification) Mam mal Ac ute Oral Laboratory rat Single Oral Dose LD 50 = >2000 mg

form /kg bw Survival MRID 47090003 (Acceptable) Insects Ac ute Contact Honey Bee

Apis mellifera 96 hour LD 50 > 10.5 μg ai/bee None MRID 47090326 (Acceptable) Two ty pes of risk quotients are calculated to evaluate the risks to birds and mamm als based on the estimated dietary

residue concentrations determined from the Kenaga nomogram: (1) dietary based RQs; and (2) dose based RQs. These RQs are not equivalent. Dietary risk quotients are calculated b y directl y comparing the concentration of a pesticide administered (or estimated to be administered) to experimental animals in the diet in a toxicity study to the concentration estimated to be on selected food items. These risk quotients do not account for the fact that smaller
- sized animals nee d to consume more food relative to their body weight than larger animals or th ose differential amounts of food are consumed depending on the water content and nutritive value of the food. The dose
- based risk quotients do account for these factors. The do se - based RQs incorporate the ingestion rate
- adjusted exposure from the various food items to the different weight classes of birds and mammals and the weight class
- scaled toxicity endpoints. Details can be found in Appendix D
. Formulas presented below are used to calculate dose
- based and dietary based risk quotients: Table IV- 1 6 . Formulas Used to Calculate Dose - Based and Dietary- Based Risk Quotients Duration Dose or

Dietary RQ Surrogate

Organism Equation Ac ute Dose
-based Birds and mammals Ac ute Daily Exposure (mg/kg
-bw) / adjusted LD 50 (mg/kg
bw) Dietary
-based Birds Kenaga EEC (mg/kg
- food item) / LC 50 (mg/kg
- diet) Chronic Dietary
-based Birds and mammals EEC (mg/kg
- food item) / NOAEC (mg/kg
- diet) Dose
-based Mammals only EEC (mg/kg
-bw) / Adjus ted NOAEL (mg/kg
-bw)

a. Birds Before the two RQ types are calculated for birds , the EECs and toxicity values are adjusted based on food intake and body weight differences so that they are comparable for a given weight class of ani mal. The size classes assessed are small (20
- gram), medium (100
- gram), and large (1000
- gram) birds
. For birds, only acute values (LD 50 s) are adjusted because dose
- based risk quotients are not calculated for the chronic risk estimation. The avian LD 50 of 6 16 mg/kg
- bw is used in this assessment to derive acute dose
- based risk quotients. However, extrapolation from one bird to another needs to consider differences in the scaling of toxicity for differences in body

weight.72

Therefore, the red
- legged partridge LD 50 of 616 mg/kg
- bw is adjusted for birds of various sizes based on the following formula, recommended b y Mineau et al. 1996:

Adj. LD 50 = LD 50 (AW/TW) (a
- 1) where adj. LD 50 is the median 50% lethal dose for the species being assessed, LD 50 is the median lethal dose in the test organism, AW is the body weight of the assessed organism, TW is the body weight for the test organism, and a is the slope of the regression line for estimating the assessed species LD 50 from the test species LD 50 (EFED default value of 1.15). Adjusted LD 50 s are calculated for small (20
- gram), medium (100
- gram), and large (1000
- gram) birds. The test organism is a red
- legged partridge with an average body weight of 0. 43 kg ( 430 grams) in the control group of the study . The resulting adjusted LD 50 s are in Table IV- 1 7 below. Table IV- 1 7 . Adjusted Avian LD 50 s for 20 - , 100 - , and 1000 - gram Birds Based on an LD 50 of 616 mg/kg - bw in Red - legged Partridge. Avian Class Body Weight Adjusted LD 50 Small 20 38 9 Mid 100 4 95 Large 1000 6 99 Acute Risk Quotients of the AI alone Table III - 1 8 presents the avian dose
- based RQs for the AI alone on apples and soy beans. For apple uses, the dose
- based RQs of 0. 2 5, 0.1 2 , and 0. 14 exceed the acute LOCs for 20 g birds consuming short grass, t all grass, and broadleaf forage/small insects and the dose
- based RQ of 0. 11 exceeds the acute LOC for 100 g birds consuming short grass. For small
- sized (20g) birds consuming short grass, the restricted use and endangered species LOCs are exceeded. The end angered species LOC is also exceeded for 20 g birds consuming the assessed food items except fruits, pods, seeds, and large insects. For mid
- sized (100 g) birds consuming short grass, the endangered species LOC is exceeded; the acute LOCs are not exceed fo r 100 g birds consuming tall grass, broadleaf forage, small insects, fruits, pods, seeds, and large insects. There is no exceedance of the acute LOCs for large
- sized (1000 g) birds consuming any of the assessed food items based on a maximum application of 0.11 applied 4 times with 7 day reapplication intervals. For so ybean use s and dose
- based RQs, there is an exceedances of the avian acute endangered species LOC for 20 g birds consuming maximum predicted residues of the AI on short grass based on a maximum application of 0.06 lbs ai/A applied 3 times with 14 day reapplication intervals. On the other hand, there is no exceedance of the acute LOCs for medium
- and large
- sized birds feeding on any of the assessed feed items or small
- sized birds feeding on tall grass, broadleaf plant, small and large insects, and seeds based on 3 applications of 0.06 lb ai/A with 14
- day reapplication intervals. There is no exceedance for all weight classes of birds feeding in or near a soy bean field when the reapplication interv al is increased to 21 day s from 14 day s . These LOC exceedances indicate that small
- and medium
- sized birds may be at risk for adverse effects on survival from exposure to the AI alone as a result of the labeled uses of the pesticide
. Potential acute ris k to birds is discussed further in the Risk Description section.73

Table IV - 1 8 . Upper Bound Kenaga, Flutriafol Acute Avian Dose - Based Risk Quotients for Apple and Soybean Uses
Site Size

Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Br oadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ Apple 20 38 9 99 0 . 2 5 ** 45 0.1 2 * 56 0.1 4 * 6 0.02

100 4 95 56 0.1 1 * 26 0.0 5 32 0.0 6 4 0.01 1000 6 99 25 0.0 4 1 2 0.02 1 4 0.0 2 2 <0.01 Soy bean (14
- day intervals ) 20 38 9 38 0.1 * 18 0.05 22 0.06 3 <0.01

100 4 95 22 0.05 10 0.02 12 0.03 1 <0.01 1000 6 99 10 0.01 5 0.01 6 0.01 0.6 <0.01 Soy bean (21
- day intervals) 20 38 9 34 0.09 16 0.04 19 0.05 2 <0.01

100 4 95 20 0.04 9 0.02 11 0.02 1 <0.01 1000 6 99 9 0.01 4 0 .01 5 0.01 0.6 <0.01 Bold value indicates LOC exceedance (**exceeds the LOC of 0.2 for restricted use and LOC of 0.1 for endangered species; *exceeds the LOC of 0.1 for endangered species) Table IV- 19 presents the avian dietary
- based RQs for the AI alon e on apples and soy beans. For apple and so ybean uses, the dietary
- based RQs from acute exposure of the AI alone to birds are all ≤ 0.0 2 . Therefore , there are no exceedances of the avian acute LOC for birds consuming the maximum predicted residues on these food items.
Table IV - 19 . Upper Bound Kenaga, Flutriafol Subacute Avian Dietary Based Risk Quotients for Apple and Soybean Uses
Site LC50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ Apple 4062 87 0.0 2 40 0.01 49 0.0 1 5 <0.01 Soy bean (14
- day intervals) 4062 32 0.01 14.5 <0.01 18 <0.01 2 < 0.01 Soy bean (21
- day intervals) 4062 30 0.01 14 <0.01 17 <0.01 2 <0.01 Size class not used for dietary risk quotients Chronic Risk Quotients of the AI alone To evaluate the chronic risk of the AI alone to birds, dietary
- based RQs are calculated using the mallard duck NOAEC of 39.2 mg/kg
- diet. The RQs are detailed in Table IV- 2 0 and in Appendix D
. The RQ s of 2. 21 , 1. 01 , and 1. 25 for the proposed use of the AI alone on apples exceeds the LOC for chronic risk to birds consuming short grass, tall grass, and broadleaf plants and small insects ,74

respectivel y . These exceedances indicate that birds may be at risk for adverse chronic effects to reproduction from chronic exposure to the AI alone as a result of the labeled apple uses . These chronic risks to birds are discussed further in the Risk Description section. For the soy bean use scenarios modeled ( Ta ble IV- 2 0 ) , there are no chronic L OC exceedances for birds consuming any of the assessed food items in soy bean fields.
Table IV - 2 0 . Upper Bound Kenaga, Flut riafol Chronic Avian Dietary Based Risk Quotients for Apple and Soybean Uses
Site NOAEC

( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ Apple 39.2 87 2. 2 1 * 40 1. 01 * 49 1. 25 * 5 0. 14 Soy bean (14D interval) 39.2 32 0.86 14.5 0.39 18 0.48 2 0.05 Soy bean (21D interval) 39.2 3 0 0.77 1 4 0.35 1 7 0.43 2 0.05 Size class not used for dietary risk quotients Bold values indicate LOC exceedances (*exceeds the LOC of 1 for chronic risk)

b. Mammals Using similar methodology to that employed for birds, the female mouse LD 50 of 179 mg/kg
- bw and the rat NOAEL of 20.6 mg/kg day /bw are adjusted to allow for an assessment of risk to mammals of various sizes based on th e following formula, which was recommended by Mineau et al. 1996: Adj. LD 50 or NOAEL = LD 50 or NOAEL (TW/AW) 0.25 LD 50 , TW, and AW were previously defined. Adjusted LD 50 s and NOAELs are calculated for small (15
- gram), medium (35
- gram), and large (1000
- gram) mammals. The test organisms are a mouse and a rat with a reference body weight of 20 and 350 grams, respectively . The resulting adjusted LD 50 s and NOAEL s are in Table IV- 2 1 below. Table IV- 2 1 . Adjusted Mammalian LD 50 s and NOAELs for 15 - , 35 - , a nd 1000 - gram Mammals Based on an Female Mouse LD 50 of 179 and NOAEL of 240 mg/kg - diet and 2 0.6 mg/kg/day- bw in Female Rat Mammalian Class Body Weight Adj usted LD50 A djusted NOAE L Small 15 192 4 5 Mid 35 156 3 7 Large 1000 67 1 6 Acute Risk Quotients of the AI alone For both proposed uses on apple and soy bean , the dose
- based RQs for the AI alone exceeded the acute LOCs for all weight classes of mammals consuming short grass with the exception of 1000 g75

birds consuming short grass in soy bean sites. In Tab le IV- 2 2 , the RQs for the AI alone are as high as 0. 4 which exceeds the restricted use and endangered species LOCs for mammals consuming short grass in apple sites . For apple use, the RQs of 0.1

– 0. 2 for mammals consuming tall grass and RQs of 0.2

– 0. 24 for mammals consuming broadleaf plants/small insects , with the exception of 1000 g mammals consuming tall grass , exceed s the acute restricted use and endangered species LOC s . F or 1000 g mammals consuming tall grass , only the endangered species LOC is exce eded
. The dose
- based RQs for all weight classes of mammals consuming fruits, pods, and large insects and granivores are < 0.03 and do not exceed the acute L OCs. These exceedances indicate that mammals may

be at risk for adverse effects on survival from acut e exposure to the AI alone as a result of the labeled uses of the pesticide and will be discussed in the Risk Description section. Dietary
- based RQs are not estimated for mammals since acute dietary mammal studies are not available. Table IV - 2 2 . Upper Bo und Kenaga, Flutriafol Acute Mamm alian Dose - Based Risk Quotients For Apple and Soybean Uses
Site Size

Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ Apple 15 192 83 0. 4 ** 38 0. 2 ** 47 0. 24 ** 5 0.03 1 0.01

35 156 57 0. 4 ** 26 0.2** 32 0. 2 ** 4 0.0 2 1 <0.01 1000 67 13 0. 2 ** 6 0.1* 7 0. 1 * 1 0.0 1 0.2 <0.01 Soy bean (14
- day intervals) 15 192 32 0.2** 14.5 0.08 18 0.09 2 0.01 0.4 0.00

35 156 22.1 0.1** 10.1 0.07 12.5 0.08 1.4 0.01 0.3 0.00 1000 67 5.1 0.08 2.4 0.03 2.9 0.04 0.32 0.00 0.07 0.00 Soy bean (21
- day intervals) 15 192 29 0.2 ** 13 0.07 16 0.08 2 0.01 0.4 <0.01

35 156 20 0.1 * 9 0.06 11 0.07 1 <0.01 0.3 <0.01 10 00 67 5 0.07 2 0.03 3 0.04 0.3 <0.01 0.06 <0.01 Bold value indicates LOC exceedance (***exceeds the LOC of 0.5 for acute, restricted use, and endangered species; **exceeds the LOC of 0.2 for restricted use and endangered species; *exceeds the LOC of 0.1 f or endangered species) Acute Risk Quotients of the Formulated Product itself A definitive acute toxicity threshold was not established for mammals exposed to the formulated product (acute LC 50 > 2000 mg form/kg); consequently , RQs are not quantitatively e stimated and are discussed further in the Risk Description section. Chronic Risk Quotients of the AI alone To evaluate the chronic risk to mammals, dose
- based and dietary
- based RQs for the AI alone are calculated using the rat NOAEL of 20.6 mg/kg bw/day and NOAEC of 240 mg/kg
- diet from the 2
- generation study in rats. The dose
- based RQs are detailed in Table IV- 2 3 and in Appendix D . The dietary
- based RQs are detailed in Appendix D
. Assuming maximum residue levels of the proposed uses, the dietary
- based ri sk quotients of the AI alone do not exc eed the chronic LOC for mammals. H owever, the dose
- based risk quotients for the 15 g and 35 g weight classes of mammals exceed the chronic risk LOC of 1. The chronic LOC of76

the AI alone is exceeded for 15 g and 35 g m ammals consuming short grass and exceeded for 15 g mammals consuming broadleaf plants and small insects in apple sites. These exceedances indicate that mammals may

be at risk for adverse effects on reproduction and growth from chronic exposure to the AI al one as a result of the labeled uses for apples and will be discussed in the Risk Description section. For so ybean uses and dose
- based RQs, there are no chronic LOC exceedances for mammals of all weight classes consuming any of the food items. Table IV - 2 3 . Upper Bound Kenaga, Flutriafol Chronic Mammalian Dose - Based Risk Quotients for Apple and Soybean Uses
Site Size

Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Gra nivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ Apple 15 4 5 83 1.8 38 0.84 47 1.0 5 0.1 1 0.03

35 3 7 57 1.6 26 0. 7 32 0.88 4 0.1 1 0.02 1000 1 6 13 0.84 6 0. 4 7 0. 5 1 0.05 0.2 0.01 Soy bean (14
- day intervals) 15 45 32.0 0.08 14.7 0.04 18 0.05 2 0.01 0.4 4 0.00

35 37 22.1 0.07 10.1 0.03 12.5 0.04 1.4 0.00 0.31 0.00 1000 16 5.1 0.04 2.4 0.02 2.9 0.02 0.32 0.00 0.07 0.00 Soy bean (21
- day intervals) 15 45 29 0.6 13 0.3 16 0.3 2 0.04 0.4 0.01

35 37 20 0.5 9 0.2 11 0.3 1 0.03 0.3 0.01 1000 16 5 0.3 2 0. 1 3 0.2 0.3 0.02 0.06 <0.01 Bold values indicate LOC exceedances (excess the LOC of 1 for chronic risk)

c. Terrestrial - phase Amphibians and Reptiles EFED currentl y uses surrogate data (birds) for terrestrial amphibians and reptiles. Risks are qualit atively

discussed in the Risk Description section. d. Beneficial Insects Potential risks to beneficial insects are discussed in the Risk Description section of this document. 3. Non - target Terrestrial Plants in Terrestrial and Semi - aquatic Environments Table IV- 2 4 presents the toxicity endpoint values used to calculate RQs and estimate risk to terrestrial receptors from flutriafol residues as a result of direct deposition and spray drift from ground and aerial applications. De tails of the RQ calculations for terrestrial plants are provided below and in Appendix E
. The potential risks to terrestrial plants are discussed further in the Risk Description section.77

Table IV - 2 4 . Flutriafol 125 g/L SC Toxicity Endpoint Values for As sessing Risk to Terrestrial Plants Exposure Scenario Species Exposure Duration Toxicity Endpoint

Value Endpoint Reference (Classification) Terrestrial Plants Seedling Emergence Monocot

–

ryegrass 21
- day EC 25 >0.12 lb ai/A; NOAEC > 0.12 lb ai/A None MRID 47090328 (Acceptable) Dicot

– soy bean EC 25 >0.12 lb ai/A; NOAEC > 0.12 lb ai/A None Vegetative Vigor Monocot
-

ryegrass EC 25 >0.12 lb ai/A; NOAEC > 0.12 lb ai/A None MRID 47090329 (Acceptable) Dicot

– sugar beet EC 25 >0.12 lb ai/A; NOAEC > 0.12 lb ai/A None Risk Quotients of the AI in its Formulated Product to Non
- Listed and Listed Monocots and Dicots Table IV- 2 5 presents RQs for the formulated product of flutriafol to terrestrial plants via ground and aerial spray

applications. For the propose d new uses of flutriafol and the maximum application rates of 0.06 and 0.11 lbs ai/A, both non
- listed and listed LOCs are not exceeded for all monocots and dicots located adjacent to treated areas, in semi
- aquatic areas, and as a result of off s ite runoff and/or spray

drift. Table IV - 2 5 . Terrestrial Plant Risk Quotient Summary for Flutriafol 125 g/L SC 1,2,3 , 4
Scenario Non - listed RQs Listed RQs

Terrestrial Adjacent area Semi - aquatic

Adjacent area Drift Terrestrial Adjacent area Semi - aquatic

Adjacent a rea Drift Maximum Rate for Apples (0. 11 lb ai/A) Ground spray Monocot <0.1 <0.47 <0.1 <0.1 <0.47 <0.1 Dicot <0.1 <0.47 <0.1 <0.1 <0.47 <0.1 Maximum Rate for Soybeans (0.06 lb ai/A) Ground spray Monocot <0.1 <0.26 <0.1 <0.1 <0.26 <0.1 Dicot <0.1 <0.2 6 <0.1 <0.1 <0.26 <0.1 Aerial spray Monocot <0.1 <0.28 <0.1 <0.1 <0.28 <0.1 Dicot <0.1 <0.28 <0.1 <0.1 <0.28 <0.1 1 Detailed calculations for RQs and TerrPlant Ver. 1.2.2 input and output are provided in Appendix E. 2 RQs for ground and/or aerial spray applications in this table were calculated for the maximum application rates for each uses
. 3 Non
- listed toxicity thresholds (EC 25 ) were all >0.12 lb ai/A for seedling emergence monocot, seedling emergence dicot, vegetative vigor monocot, and vegetative vi gor dicot. 4 Listed toxicity thresholds (NOAEC/EC 05 ) were all > 0.12 lb ai/A for seedling emergence monocot, seedling emergence dicot, vegetative vigor dico t And vegetative vigor monocot. B. Risk Description The risk hypothesis states that the use of f lutriafol and its formulated product as a fungicide for terrestrial crop sites has the potential to adversely affect survival , reproduction, and/or growth of78

non - target aquatic and terrestrial animals and plants, including Federally
- listed endangered and threatened species. Based on the available ecotoxicity data and predicted environmental exposures, risks may

occur to the following taxonomic groups based on the proposed new uses of the AI alone and/ or its formulated product of flutriafol : Apple s ( 4 appl ications @ 0.11 lb ai/A with 7 - day intervals) The acute endangered species level of concern (LOC) is estimated to be exceeded for these taxa when ground applied to apple sites:

 acute dose
- based exposure of the AIalone to 20 g b irds ( including terrestri al
- phase amphibians and reptiles) feeding on short grass , tall grass, broadleaf forage, and small insects,  acute dose
- based exposure of the AI alone to 100 g birds ( including terrestrial
- phase amphibians and reptiles) feeding on short grass, and  acute dose
- based exposure of the AIalone to 15 g, 35 g, and 1000 g mammals feeding on short grass, tall grass, broadleaf forage and small insects , The acute restricted use level LOC is estimated to be exceeded for these taxa when ground applied to apple sites :

 acute dose
- based exposure of the AIalone to 20 g birds ( including terrestrial
- phase amphibians and reptiles) feeding on short grass ,  acute dose
- based exposure of the AIalone to 15 g and 35 g mammals feeding on short grass, tall grass, broadleaf forage and small insects, and  acute dose
- based exposure of the AIalone to 1000 g mammals feeding on short grass The chronic risk LOC is estimated to be exceeded for these taxa when ground applied to apple sites:

 chronic dietary
- based exposure of the AIalone to birds ( including terrestrial
- phase amphibians and reptiles) feeding on short grass, tall grass, and broadleaf plants and small insects,  chronic dose
- based exposure of the AIalone to 15 g mammals feeding on short grass, broadleaf plants and small insects , and  chronic dose
- based exposure of the AIalone to 35 g mammals feeding on short grass, , Soybeans (3 applications @ 0.06 lb ai/A with 14 - day intervals) The acute endangered species LOC is estimated to be exceeded for these taxa when ground or aeriall y applied to so ybean sites:

 acute dose
- based exposure of the AIalone to 20 g birds feeding on short grass and  acute dose
- based exposure of the AIalone to 15 g and 35 g mammals feeding on short grass79

Soybean s (3 applications @ 0.06 lb ai/A with 21 - day in tervals) The acute endangered species LOC is estimated to be exceeded for these taxa when ground or aeriall y applied to so ybean sites:

 acute dose
- based exposure of the AIalone to 15 g and 35 g mammals feeding on short grass The acute restricted use LOC is estimated to be exceeded for these taxa when ground or aeriall y applied to soy

bean sites:

 acute dose
- based exposure of the AIalone to 15 g mammals feeding on short grass Apples and Soybeans However, the AI alone and its formulated product do n ot exceed the endangered s pecies LOCs for the following group ( s ) :

 acute and chronic exposure s to freshwater fish (inclu ding aquatic
- phase amphibians),  acute and chronic exposures to estuarine/marine fish,  acute exposure to freshwater invertebrate s ,  expo sure to non - listed aquatic vascular and nonvascular plants ,  exposure to listed aquatic vascular and nonvascular plants, and  exposure to non - listed and listed terrestrial plants 1. Risks to Aquatic Animals and Plants In the conceptual model, spray drif t and surface runoff/leaching to adjacent bodies of water are predicted as the most likely sources of exposure of flutriafol to non
- target aquatic animals and plants. Risks to aquatic species (i.e. fish, invertebrates, and plants) are assessed based on mo deled estimated environmental concentrations (EECs) and available toxicity data. The aquatic EECs for the ecological exposure to the acute and chronic toxicity values of the AIalone are estimated using GENEEC2 ( Table III - 5 ) or PRZM/EXAMs ( Table III - 7 ) , while the ecological exposure to the acute toxicity

of the formulated product itself is estimated using AgDRIFT ( Table III - 10 ). For fish and invertebrates , the first part focuses on the risk of the active ingredient alone to these species. The latter part s focus on the risks of the formulated product itself to these species because it appears that Flutriafol 125 g/L SC is more toxic than the active ingredient alone to aquatic species. For aquatic plants, risk is assessed based on the active ingredient in it s formulated product.

a. Aquatic Animals 

### Acute Ris k to Freshwater and Estuarine/marine Fish

(1) Acute Risk of the AI Alone to Fish80

Available acute toxicity

data indicates that the AI alone is slightly toxic to freshwater fish and no more than sli ghtl y toxic to estuarine/marine fish on an acute basis. The acute RQs based on the AI alone for freshwater fish are all <0.01 and do not exceed the acute listed LOC of 0.05
. Acute RQs for estuarine/marine fish exposed to the AI alone are not quantitatively calculated; in order to compare these acute values for freshwater and estuarine/marine fish with an exposure value, the highest peak GENEEC EEC of 0.021 mg ai/L in surface water is selected from the apple use scenario. A comparison of the ecotoxicity valu es of the AI alone listed above (L C 50 values ranging from 33

– >72.2 mg ai/L) with the peak GENEEC EEC ( 0.021 mg ai/L), indicates a 1 5 00 to 34 00
- fold difference between the highest peak EEC and the concentrations which produced a lethal effect on 50% of th e fish species. The fish L C 50 value of the AI alone w ould need to be ≤0. 42 mg ai/Lto yield an RQ that exceeds the acute endangered LOC of 0.05.

( 2 ) Acute Risk of the Formulated Product itself to Fish Risk to aquatic receptors from exposure to the formulated product containing the active and inert ingredients is estimated through spray drift alone. The L C 50 values for freshwater and estuarine/marine fish exposed to the formulated product itself range fro m 7.9 mg form/L to >17 mg form/L. A comparison of ecotoxicity values of the formulation with the highest AgDRIFT EEC for the so ybean aerial scenario (0.0036 mg form/L) for Flutriafol 125 g/L SC indicates a 2200 to 4722
- fold difference between the highest AgDRIFT EEC and the concentrations which produced a lethal effect on 50% of the fish species. A fish L C 50 of the formulated product would need to be ≤0.072 mg form/L to yield an RQ that exceeds the acute endangered LOC of 0.05.

(4) Acute Risk Summary for Fish Exposed to the AI alone and to its Formulat ed Product Based on the available information, this ecological risk assessment for freshwater and estuarine/marine fish, including Federally
- listed endangered and threatened species, suggests there is no indication of risk for adverse effects on survival to fish, both freshwater and estuarine/marine species, from acute exposure to flutriafol and its formulated product as a result of the labeled uses (Appendix C ). There is some uncertainty regarding the acute to acute ratio (AAR) value from different fish s pecies to evaluate the acute risk of the formulated product to estuarine/marine fish; however, if estuarine/marine fish survival studies are submitted and are more or less toxic than estimated, then risks may be under
- or over - estimated , respectively , for this taxonomic group. The submission of acute Flutriafol 125 g/L SC data with estuarine/marine fish would be useful in reducing the uncertainty. 

### Chronic Risk to Freshwater and Estuarine/marine Fish

(1) Chronic Risk of the AI alone to Fish Following chronic exposure to the AI alone , the NOAEC for freshwater fish is 4.8 mg ai/L based on significant reductions of post
- hatch survival and the estimated NOAEC value for estuarine/marine fish is >11 mg ai/L. Chronic risk quotients for the AI alone to freshwater and estuarine/marine are well below the chronic LOC. A comparison of the NOAECs of the AI alone81

with the highest 60
- day

GENEEC EEC (0.0 2 1 mg ai/L) indicates a 154 to 354
- fold difference between the EEC and the concentrations that produced no significant reproductive or growth effects. A fish NOAEC value of the A I alone w ould need to be ≤0.0 29 mgai/Lto yield an RQ that exceeds the chronic risk LOC of 1.0.

( 2 ) Chronic Risk Summary for Fish Exposed to the AI alone Consequently , freshwater and estuarine/marine fish species are not at risk for adverse effects on reproduction and growth from exposure to the AI alone
. Similar to the acute risks for fish, there is some uncertainty regarding the acute to chronic ratio (ACR) value derived from different fish species to evaluate the chronic risk of AIalone to estuarine/marine fish. H owever, if estuarine/marine fish early life
- stage studies with the AI alone are submitted and are more sensitive than estimated, then risks may be underestimated for this taxonomi c group. The submission of chronic toxicity data with estuarine/marine fish would be useful in reducing the uncertainty. 

### Acute Risk to Freshwater and Estuarine/marine Invertebrates

(1) Acute Risk of the AI Alone to Invertebrates Flutriafol , the active ingredient, is slightly toxic to both invertebrate species . Based on the most conservative aquatic exposure scenario for the AI alone , the peak GENEEC EEC is 0.0 21 mg ai/L
. Compared to the daphnid and oy ster acute toxicity value s of 67 and 25 mg ai/L , resp ectivel y, the RQs are <0.01 and do not exceed the acute listed species LOC of 0.05. A comparison of the ecotoxicity

values of the AI alone listed above ( acute toxicity values ranging between 25

– 67 mg ai/L) with peak GENEEC EEC in surface water (0.02 1 m g ai/L) indicates a 1190 to 31 00
- fold difference between the EEC and the concentrations which produced an effective concentration on 50% of the invertebrate species. An invertebrate EC 50 value of the AI alone w ould need to be ≤0. 42 mg ai/L to yi eld an RQ that exceeds the acute endangered LOC of 0.05.

( 2 ) Acute Risk of the Formulated Product itself to Invertebrates Risk to aquatic receptors from exposure to the formulated product containing the active and inert ingredients is estimated through spray drift alone. The E C 50 values for freshwater and estuarine/marine invertebrates exposed to the formulated product itself range from 2.5 mgform/L to 7.0 mg form/L . A comparison of ecotoxicity values of the formulation itself with the highest AgDRIFT EEC for the soy bean aerial scenario (0.0036 mg form/L) for Flutriafol 125 g/L SC indicates a 694 to 1944
- fold difference between the highest AgDRIFT EEC and the concentrations which produc ed an immobility effect on 50% of the invertebr ates s pecies. An invertebrate E C 50 value of the formulated product itself would need to be ≤0. 072 mg form/Lto yield an RQ that exceeds the acute endangered LOC of 0.05.

(3 ) Acute Risk Summary for Invertebrates Exposed to the AI Alone and to its Formulat ed Product82

Based on the available information, this ecological risk assessment for freshwater and estuarine/marine invertebrates, including Federally
- listed endangered and threatened species, suggests that risk of adverse effects at levels that exceed L O Cs to survival to invertebrates is expected to be minimal for freshwater and estuarine/marine species, from acute exposure to the AI alone
. For the formulated product itself, the acute risks to invertebrates inhabiting water bodies adjacent to treated apple and soy

bean fields are expected to be minimal. Similar to the risks for fish, there is s ome uncertainty regarding the AAR value derived from different invertebrate species to evaluate the acute risk of the formulated product to estuarine/marine invertebrates . H owever, if estuarine/marine invertebrate survival studies with the formulated product ( Flutriafol 125 g/L SC ) are submitted and are more or less sensitive than estimated, then risks may be under
- or over - estimated , respectively , for this taxonom ic group. The submission of acute toxicity data using Flutriafol 125 g/L SC with estuarine/marine invertebrates would be useful in reducing the uncertainty. 

### Chronic Risk to Freshwater and Estuarine/marine Invertebrates

(1) Chronic Risk of the AI Alone to Invertebrates Following chronic exposure to the AI alone , the NOAEC for freshwater invertebrates is 0.31 mg ai/Lbased on significant reductions of growth and reproduction and the estimated NOAEC value for estuarine/marine invertebrates , based on an ACR of 216, is 0.12 mg ai/L. There are no chronic LOC exceedances for freshwater and estuarine/marine invertebrates based on the most conservative aquatic exposure scenarios; thus, freshwater invertebrates, including Federall y- listed endangered and threatened species, there is no indication for adverse effects on reproduction and growth at levels that exceed LOCs from chronic exposure to the active ingredient alone . An invertebrate NOAEC of the A I alone would need to be ≤0.0 29 mg ai/L to yi eld an RQ that exceeds the chronic risk LOC of 1.0.

( 2 ) Chronic Risk Summary for Invertebrates Exposed to the AI Alone Based on the available information, this ecological risk assessment for freshwater and estuarine/marine invertebrates, including Federally
- listed endangered and threatened species, suggests there is no indication of risk for adverse effects on reproduction and growth to invertebrates, both freshwater and estuarine/marine species, from chronic exposure to the AI alone
.

b. Aquatic Plants 

### Risk to Non - listed Plants

( 1 ) The Risks of the AI in its Formulated Product to Non - listed Aquatic Plants83

The non - listed toxicity values of the AIin its product for non
- listed aquatic vascular and nonvascular pl ants are 0.78 mg ai/L and 0.46 mgai/L , respectivel y. Based on the most conservative exposure scenario and peak GENEEC EECs, the non
- listed plant RQs of <0.1 do not exceed the LOC for non
- listed aquatic vascular and nonvascular plants adjacent to soy bean and apple sites exposed to the AI in its product (Flutriafol 125 g/L SC ) as a result of runoff and spray drift. ( 2 ) The Risks of the Formulated Product itself to Non - listed Aquatic Plants Risk to non - listed aquatic plants from exposure to the formulated product containing the active and inert ingredients is estimated through spray drift alone. The EC 50 values of the formulated product itself for non
- listed aquatic vascular and nonvascular plants are 6.6 mg form/Land 3.9 mg form/L, respectivel y. A compari son of the ecotoxicity values of the formulation with the highest AgDRIFT EEC for the so ybean aerial scenario (0.0036 mg form/L), the RQs are <0.1 and do not exceed the LOC for non
- listed aquatic vascular and nonvascular plants as a result of spray drift
. 

### Risk to Listed Plants

( 1 ) The Risks of the AI in its Formulated Product to Listed Aquatic Plants The listed toxicity values of the AIin its product for listed aquatic vascular and nonvascular plants are 0.018 mg ai/L and 0.1 mg ai/L, respectivel y. Bas ed on the most conservative exposure scenario and peak GENEEC EECs, the RQ s of <0.6 do not exceed the LOC for listed aquatic vascular and nonvascular plants adjacent to soy bean sites exposed to the AI in its product as a result of runoff and spray drift
. B ased on the refined exposure scenario and peak PRZM/EXAMs EECs, the RQ s of <0.6 do not exceed the L OC for listed aquatic vascular and nonvascular plants adjacent to apple sites
. ( 2 ) The Risks of the Formulated Product itself to Listed Aquatic Plants Ri sk to listed aquatic plants from exposure to the formulated product containing the active and inert ingredients is estimated through spray drift alone. The EC 50 values of the formulated product itself for listed aquatic vascular and nonvascular plants are 6.6 mg form/Land 3.9 mg form/L, respectivel y. A comparison of the ecotoxicity values of the formulation with the highest AgDRIFT EEC for the so ybean aerial scenario (0.0036 mg form/L), the RQs are <0.1 and do not exceed the LOC for listed aquatic vascular and nonvascular plants as a result of spray drift. (4) Summary of the Risks to Aquatic Plants Exposed to the AI in its Formulated Product and to the Formulated Product itself This ecological risk assessment for aquatic plants, including Federally
- liste d endangered and threatened species, suggests that listed aquatic plants inhabiting water bodies adjacent to treated84

apple and so ybean sites are unlikely to be at risk for adverse effects on survival and growth from exposure to the AI in its product and th e formulated product itself. In addition, there is uncertainty regarding the toxicity value used on the assumption that the formulation inerts in the formulated product is more toxic than the AI to evaluate the risk of the AI alone to aquatic plants
. The submission of toxicity data with the AI alone with aquatic plants would be useful in reducing the uncertainty.

c. Aquatic - phase Amphibians EFED currentl y uses surrogate data (freshwater fish) for non
- target aquatic amphibians. Freshwater fish risk data indicates that aquatic
- phase amphibians are not anticipated to be at risk for adverse effects on survival, growth , and reproduction from exposures to the AI alone (acute and chronic) as a result of runoff and spray drift or its formulated product (acute onl y) as a result of spray drift to adjacent water bodies following flutriafol treatments in soy bean and apple sites. Thus, there is no indication of risk for adverse effects on survival , reproduction, and growth to aquatic
- phase amphibians exposed to the active ingredient of flutriafol. 2. Risks to Terrestrial Animals and Plants In the conceptual model, dietary ingestion of flutriafol residues on vegetative matter and insects on treated areas and off

- site spray

drift and runoff of the residues to low
- l yi ng untreated areas are predicted as the most likely sources of exposure of flutriafol to non
- target terrestrial animals and plants. Risks to terrestrial species (i.e. birds, mammals and plants) are assessed based on modeled estimated environmental concentrations (EECs) and available toxicity data. Terrestrial EECs for the ecological exposure to the acute and chronic toxicity values of the AIalone are estimated using T
- REX ( Table III - 6 , - 7 , and - 8 ) and TerrPlant ( Table III - 9 ) ; for the ecological exposure to the acute toxicity

of the formulat ed product itself is estimated using AgDRIFT ( Table III - 10 )
. Mammal toxicity

data with the formulated product (Flutriafol 125 g/L SC) is available for evaluation in this ecological risk assessment. Thus, for mammals, the first part focuses on the risk of the AI alone to mammals; then, the latter parts focus on the risks of the formulated product to mammals.
a. Terrestrial Animals 

### Acute Risk to Birds For spraying in apple sites , the dose
- based RQs of 0.1 1
- 0. 2 5 exceed the acute restricted use and endangered species LOCs for small
- sized (20 g) and medium
- sized (100 g) birds consuming short grass and/or tall grass, broadleaf forage, and small insects with residues of the AI alone
. N o acute LOC exceedances for large - sized (1000 g) birds and those birds that forage mainly on fruits, pods, seeds, and large insects with residues of the AI alone
. S mall and medium sized birds may be at risk for adverse effects on survival from acute exposure to AI residues alone as a re sult of the labeled uses for control of s cab , powdery mildew , or quince or cedar apple rust on apples
. In addition, th e85

RQs from mean Kenaga EECs indicate no exceedance of the LOC for 20 g birds foraging any of the feed items with AI residues alone
. For s praying in soy

bean fields using the 14
- day reapplication interval , the dose
- based RQ of 0.1 exceeds the acute endangered species LOC for small
- sized birds feeding on short grass with residues of the AI alone
. There is no exceedance of the acute LOCs for sm all
- sized bird feeding on tall grass, broadleaf plants, large and small insects, and seeds and for medium
- and large
- sized birds feeding on any of the assessed food items. When the reapplication interval is increased to 21 day s , for soy

bean use, there are no acute LOC exceedances for all weight classes of birds foraging food items with residues of the AI alone
. The RQs from mean Kenaga EECs did not exceed the LOCs for acute risk to birds in soy bean fields. Although there is an exceedance of the acute LOC, the potential risk for adverse effects on survival is based on the assumption that small
- and medium
- sized birds are feeding exclusively within agricultural areas where apples and so yb eans are grown. The exceedance to birds follo wing flutriafol treatments is based on the assumption that birds occupy , exclusively and permanently , the area of apple and so ybean uses, and forag e on f eed items with AI residues alone
. To the extent that those birds do not reside exclusively and permanently

within the use area, exposure will be less and risk is presumably less. In addition, the risks to passerine bird species forging in or nearb y treated areas cannot be precluded at this time. Until toxicity data is submitted, the potential impact to passerine birds to flutriafol is uncertain and these birds are assumed to be directl y affected b y the active ingredient as well. The maximum use scenario for apples in this baseline risk assessment assumes four applications of flutriafol per season at 0.11 lbs ai/A an d 7
- day reapplication intervals to birds. F or 20 g birds feeding on short grass, there is a potential for risk if flutriafol is applied two or more times and for 20 g birds feeding on tall grass, broadleaf plants, and small insects , i t require s three or more applications o f the AI alone to exceed the LOC. It requires four or more applications for potential risk to 100 g birds feeding on short grass with residues of the AI alone
. For soy beans, the increase of the reapplication interval to 21 day s from 14 day s results in no acute LOC exceedances for birds. In an effort to characterize the potential risk to birds based on dietary exposures from apple and soy bean uses, dietary
- based EECs were estimated and compared to the L C 50 of the AIalone. The subacute toxicity

value of 408 2 mg/kg
- diet is compared to predicted avian doses on food residues of the AI alone . The dietary
- based RQs of <0.01

– 0.3 do not exceed the acute LOCs for birds foraging vegetative matter and insects with flutriafol residues. Thus , avian species residing in soy bean sites are not at risk to adverse effects on survival from acute dietary exposure to the AI alone as a result of the labeled uses. The acute ris ks to birds from the formulated product itself are not estimated since bird acute studies with the formulated product or extrapolated values are not available. However, mammal acute data with the formulated product suggest the product is less toxic than the AI ; it is possible86

that birds are not at risk to the formulated product, Flutriafol 125 g/L SC. Submi ssion of acute studies of the formulated product with birds would be helpful in removing the uncertainty
. 

### Chronic Risk to Birds For spraying in apple sites per label and maximum predicted residue levels (upper bound EECs), the chronic RQs of 1. 0

– 2. 2 e xceed the chronic risk LOC (LOC >1.0) for birds feeding on short grass, tall grass, broadleaf forage/small insects with residues of the AI alone . For application s of flutriafol to soy

beans , the re is no exceedance of the chronic risk LOC for birds feeding o n any of the assessed food items with residues of the AI alone
. Furthermore , there are no LOC exceedances for birds foraging fruits, pods, seeds or large insects with flutriafol residues in apple or so ybean sites
. In an effort to further characterize the potential risk to birds from application s to apples ( 0. 11 lb ai/A x 4 applications w ith 7D intervals ) and so yb eans (0.06 lb ai/A x 3 applications with 21D intervals and 0.06 lb ai/A x 3 applications x 14D intervals ) , terrestrial dietary exposures of the A I alone were esti mated and compared to the NOAEC of 39.2 mg ai/kg
- diet. On the other hand, the chronic RQs for the soy

beans were 0.05 to 0. 86 , which are lower than the LOC of 1. Thus, birds are at risk for adverse effects on growth and reproduction from chronic dietary exposure to the AI alone as a result of the apple use , but not for so ybean use . Although there is an exceedance of the chronic LOC, the potential risk for adverse effects on growth and reproduction is based on the assumption that birds are fe eding exclusively within agricultural areas where apples are grown. The exceedance to birds following application s to apples is based on the assumption that birds occup y, exclusively and permanentl y, the area of proposed use , and foraging feed items with f lutriafol residues. To the extent that those birds do not reside exclusively and permanentl y within the area, exposure will be less and risk is presumably less. The chronic risks to birds from the formulated product itself are not estimated since bird reproduction studies with the formulated product , modeling, or extrapolated values are not available. Graph IV- 1 below illustrates the number of applications needed to exceed the L OC for chronic risk to birds based on four applications of 0. 11 lb ai/A at 7 day s intervals with a default foliar half
life of 35 day s. Based on the graph, the upper
- bound Kenaga EECs exceed the L OC of 1 (NOAEC = 39.2 mg ai/kg diet) for birds foraging short grass after two application s ; birds foraging broadleaves/small insects aft er three applications; and birds foraging tall grass after four applications. Based on the available information, this ecological risk assessment for non - passerine and passerine birds , including Federally
- listed endangered and threatened species, suggests there is a potential for risk to adverse effects on survival, reproduction , and growth to birds , both non - passerine and passerine species, foraging on or near treated apple sites from exposure to the AI alone
. For birds foraging on or near so yb ean fields, there is no indication of risk for adverse effects on survival, reproduction, and growth to birds from exposure to the active ingredient of flutriafol.87 Terrestria l R esi dues (u pper bound est ima te s)

vs Av ia n LO Cs (a s di etar

y concent rat io ns)

0. 00 10. 00 20. 00 30. 00 40. 00 50. 00 60. 00 70. 00 80. 00 90. 00 100. 00

0 4 8 12 16 20 24 28 32 36 40 44 48 51 55 59 63 67 71 75 79 83 87 91 95 99 103 Day sConcentration (mg ai/kg dietary item)

Sh ortG ras s Ta ll Gr as s Br oadl eaf pl ant s/sm I ns ec ts Fruit s/p ods /se eds /lgin se cts Av ia n Chroni c L OC Graph IV - 1 . Number of applications required to exceed the LOC of 1 for adverse effects of growth and reproduction to birds.88



### Acute Risk to Mammals

(1) Acute Risk of the AI Alone to Mammals Based on the highest exposure scenario (apples) for the AI alone and upper bound EECs, the dose
based RQs of 0.1

– 0.4 exceed the acute restricted use and endangered species L OCs for 15 g, 35 g and 1000 g mammals where apples are grown. For both soy bean use s (3 applications @ 0.06 lb ai/A with either 14
- day

or 21
- day

intervals) , the acute restricted use and endangered LOCs are exceeded for 15 g and 35 g mammals feeding on short grass with residues of the AI alone . The dose
- based RQs for all weight classes of mammals that consum e fruits, pods, and large insects and granivores are < 0.03 for all use scenarios and do not exceed the acute LOCs. Thus , these exceedance s indicate that mammals may be at risk for adverse effects on survival from acute exposure to the AI alone as a result of the labeled uses of the fungicide. The maximum use scenario for so ybeans and apples in this baseline risk assessment assumes three an d four applications, respectivel y, per season. Considering lower numbers of applications at 0.11 lbs ai/A and 7
- day

reapplication intervals (apple), for 15 g and 35 g mammals feeding on short grass, there is a potential for risk if flutriafol is applied on e or more times. For 15 g and 35 g mammals feeding on tall grass, broadleaf plants, and small insects and for 1000 g mammals feeding on short grass , it requires two or more applications of the AI to exceed the LOC. It requires four or more applications to 1000 g mammals feeding on broadleaf forage and small insects. Considering lower numbers of applications at 0.06 lbs ai/A and either 14
- day or 21
- day intervals (so ybean), for 15 g and 35 g mammals feeding on short grass with residues of the AI alone , there is a potential for risk if flutriafol is applied two or more times to exceed the LOC. The dietary
- based risks for the AI alone are not estimated since dietary mammal studies or extrapolated values are not available.

(2) Acute Risk of its Formulated Pro duct itself to Mammals Acute RQs for mammals exposed to the formulated product itself are not quantitatively calculated. In order to compare the acute value of the product itself to mammal with an exposure value, the highest AgDRIFT EEC of 0.0036 mg form/L is selected from the soy bean aerial use scenario. A comp arison of the ecotoxicity value of the product itself ( >2000 mg form/kg) with the highest EEC, indicates a 556,000
- fold difference between the AgDRIFT EEC and the concentration which produced a leth al effect on 50% of the mammalian species.

(3) Acute Risk Summary for Mammals Exposed to the AI alone and to its Formulated Product Although there is an exceedance of the acute LOCs for the AI alone , the potential risk for adverse effects on survival is based on the assumption that mammals are feeding exclusively within agricultural areas where apples and so ybeans are grown. The exceedance to 15 g, 35 g, and 1000 g mammals following flutriafol treatments is based on the assumption that mammals occup y, exc lusively

and permanently , the area of apple and soy bean uses, and forage on feed items with residues of the AI alone . To the extent that those mammals do not reside exclusively and89

permanentl y within the area, exposure will be less and risk is presumabl y l ess. In addition, for the soy bean scenario s with residues of the AI alone , the RQs from mean Kenaga EECs did not exceed LOCs. There are exceedances from mean Kenaga EECs with some mammals in the apple scenario, however. In addition, the formulated product of flutriafol, Flutriafol 125 g/LSC, is not toxic to mammals and the potential acute risk of the formulated product to mammals is likely to be minimal. 

### Chronic Risk to Mammals For spraying in apple sites and maximum predicted residue levels (upper bound EECs), the dietary
- based risk quotients do not exceed LOC of 1 for chronic risk to mammals . However, based on dose
- based RQs, there is an exceedance of the chronic risk LOC for 15g and 35g mammals consuming short grass, an exceed ance for 15 g mammals co nsuming broadleaf plants and small insects in apple fields with residues of the AI alone . On the other hand, for soy bean use s and dose
based RQs, there were no L OC exceedances for mammals foraging any of the assessed food items with residues of the AI alon e . Consequently , some mammal species are at risk for adverse effects on growth and reproduction from chronic exposure to the AI alone as a result of the applications in these areas where apples are grown
. The maximum use scenario for apples assumes four applications per ye ar. Considering lower numbers of applications, for 15 g and 35 g mammals feeding on short grass, there is a potential for chronic risk if flutriafol is applied to apples three or more times. Again, although there is an exceedance of the chronic L OC for the AI alone , the potential risk for adverse effects on growth and reproduction is based on the assumption that mammals are feeding exclusively

within agricultural areas where apples are grown. The exceedance to those mammals following a

pplications in apple sites is based on the assumption that mammals occupy , exclusively and permanently , the area of proposed use, and forag e on feed items with residues of the AI alone
. To the extent that those mammals do not reside exclusively and permanently

within the area, exposure will be less and risk is presumably less. The chronic risks to mammals from the formulated product itself are not estimated since mammal reproduction studies with the formulated product , modeling, or extrapolated values are not available. Based on the available information, this ecological risk assessment for mammals, including Federall y- listed endangered and threatened species, suggests there is a potential for risk to adverse effects on survival, reproduction, and growth to mammals foraging on or near treated apple sites from exposure to the AI alone. For mammals foraging in or near treated soy bean fields exposed to 3 applications of 0.06 lb ai/A with 14
- day intervals , there is a potential risk for adverse effects on surv ival to mammals from exposure to the AIalone . On the other hand, there is no indication of risk for adverse effects on reproduction and growth to mammals foraging on or near treated soy bean fields from 3 applications of the AI at 0.06 lb ai/A with 21
- day intervals
.90 b. Terrestrial Plants In the conceptual model, spray drift, runoff and wind erosion of soil particles with resulting residues on upland and/or wetland foliage and soil are the most likel y sources of flutriafol exposure to non - target terre strial plants, including Federall y- listed endangered and threatened species. Risks to terrestrial plants species are assessed based on modeled EECs and available toxicity data of the AI in its formulated product . As part of the baseline assessment, expos ure concentrations of flutriafol to non - target terrestrial plants are modeled according to the labeled maximum application rates for the proposed uses. Terrestrial plant exposures were estimated using the TerrPlant 1.2.2 model. 

### Risk to Non - listed Terres trial Plants Based on the toxicity

data presented in Ecological Effects section, the results indicate that for soy bean and apple uses, the non
- listed plant LOC is not exceeded for monocots and dicots located adjacent to treated areas, inhabiting semi
- aquatic areas, and as a result of a combination of runoff and /or spray drift. 

### Risk to L isted Terrestrial Plants The listed plant LOC is not exceeded for monocots and dicots located adjacent to treated apple and soy bean areas, inhabiting semi
- aquatic areas, and as a result of a combination of runoff and /or spray drift.
c. Terrestrial - phase Amphibians and Reptiles EFED currentl y uses surrogate data (birds) for non
- target terrestrial amphibians and reptiles. Bird risk data indicate that terrestrial
- phase amph ibians and reptiles may be at risk for adverse effects on survival, growth and reproduction from acute and chronic dietary exposures to the AI alone as a result of consuming contaminated short grass, tall grass, broadleaf forage, and small insects followin g spraying in apple sites
. Also, the bird risk data indicates that terrestrial
- phase amphibians and reptiles may be at risk for adverse effects on survival from acute dietary exposures to the AIalone as a result of consuming contaminated short grass follo wing treatments in soy bean fields. However, the resulting bird acute risk data for the so ybean scenario indicates that when the reapplication interval is increased to 21 days from 14 day s, the terrestrial
- phase amphibians and reptiles are not anticipated t o be at risk from flutriafol treatments via acute or chronic exposures. Since terrestrial
- phase amphibians do not produce eggs in the exact manner as birds, the phy siology

of female amphibian s that are developing eg gs within their body are similar to female birds . Thus, the observed adverse effects o n hatchability in avian reproduction studies with the AI indicate terrestrial
- phase amphibians may have hatchability difficulties from exposure to the contaminated food items with residues of the AI alone
.

d. Beneficial Insects The available terrestrial insect toxicity data, based on tests with honey bees, suggest that the AI91

alone and its formulated product are practicall y non - toxic to bees on an acute contact basis. The LD 50 values range from >10.5 μg ai/bee to >155 μg ai/bee. Risk to beneficial insects in the direct treatment area exposed to the AI alone or its formulated product is expected to be minimal; consequentl y, precautionary labeling for honey

bee protections is not required at this time. 3. Review of Incident Data FIFRA 6(a) ( 2) incident data add lines of evidence to risk predictions from the baseline assessment thus supporting the risk predictions with actual effects in the field. As expected for a new pesticide, n o incidents of flutriafol damage are recorded in the Ecological Incident Information Sy stem (EIIS) as of August 2008. 4. Endocrine Effects EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended b y FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Foll owing the recommendations of its Endocrine Disruptor Screening and Testing Advisory

Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of the program, androgen and thyroid hormone s ys tems, in addition to the estrogen hormone s ys tem. EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife. When the appropriate screening and/or testing protocols being considered under the Agency ’s Endocrine Disrupter Screening Pro gram (EDSP) have been developed and vetted, flutriafol may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. 5. Federally Threatened and Endangered (Listed) Species Concerns
a. Action Area For listed species assessment purposes, the action area is considered to be the area affected directly or indirectl y b y the Federal action and not merely the immediate area involved in the action. At the initial baseline , the risk assessment considers broadly described taxonomic groups and so conservativel y assumes that listed species within those broad groups are co
- located with the pesticide treatment area. This means that terrestrial plants and wildlife are assumed to be located on or adjacent to the treated site and aquatic animal s and plants are assumed to be located in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area that has the relatively highest potenti al exposure to the pesticide, and that exposures are likely to decrease with distance from the treatment area. At this time EFED cannot make a “no effect” or “may effect” determination if the assumptions associated with the baseline action area result in RQs that are below or above the listed species LOCs since the Service(s) has not identified which listed species and critical habitat are potentiall y implicated. Furthermore, if RQs are below the listed species LOCs for a given taxonomic group , this may indicate a “no concern” for indirect effects upon listed species that depend upon the taxonomic group covered by the RQ as a resource. However, in situations where the baseline92

assumptions lead to RQs in excess of the listed species LOCs for a given tax onomic group, a potential for a "may

affect" conclusion could exist and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon 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 these species, and the locations of use sites could be considered along with available information on the fate and transport properties of the pesticide t o determine the extent to which baseline assumptions regarding an action area appl y to a particular listed animal. These subsequent refinement steps could consider how this information would impact the action area for a particular listed animal and may po tentially

include areas of exposure that are downwind and downstream of the pesticide use site.

b. Taxonomic Groups Potentially at Risk The baseline risk assessment for endangered species indicates that flutriafol TGAI exceed s the LOCs for the specif

ied use scenario tabulated in Table IV- 2 6 for apples and Table IV- 2 7 for soy beans for the following taxonomic groups: Table IV- 2 6 . Flutriafol TGAI Endangered Species LOC Exceedances for Apple Use Levels of Concern Taxa Acute Endangered Species Chroni c

Risk Listed

Plants Birds ( including Reptiles and Terrestrial
-phase Amphibians) 20 g Yes Yes 100 g Yes 1000 g No Mammals 15 g Yes Yes 35 g Yes Yes 1000 g Yes Yes Freshwater ( including Aquatic
phase Amphibians) and Estuarine/marine Fish No No Freshwater and Estuarine/marine Invertebrates No No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No93

Table IV- 2 7 . Flutriafol TGAI Endangered Species LOC Exceedances for So ybean Use Levels of Concern Taxa Acute Endangered Species Chronic

Risk Listed

Plants Birds ( including Reptiles and Terrestrial
-phase Amphibians) 20 g Yes No 100 g No 1000 g No Mammals 15 g Yes No 35 g Yes No 1000 g No No Freshwater ( including Aquatic
phase Amphibians) and Estuarine/marine Fish No No Freshwater and Estuarine/marine Invertebrates No No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No The bas eline risk assessment for endangered species indicates that the formulated product of flutriafol, Flutriafol 125 g/L SC, exceed s the LOCs for the specified use scenario tabulated below ( Table IV- 2 8 for apples and soybeans ) for the following taxonomic group s: Table IV- 2 8 . Flutriafol 125 g/L SC Endangered Species LOC Exceedances for Apple and Soybean Uses Levels of Concern Taxa Acute Endangered Species Listed Plants Birds (including Reptiles and Terrestrial
-phase Amphibians) 20 g No data 100 g 1000 g Mammals 15 g No 35 g No 1000 g No Freshwater (including Aquatic
phase Amphibians) and Estuarine/marine Fish No Freshwater Invertebrates No Estuarine/marine Invertebrates No Terrestrial Monocots No Terrestrial Dicots No Aquatic Vascular Plants No Aquatic Non
- Vascular Plants No

1 . Discussion of Risk Quotients The Agency ’s LOC for endangered and threatened birds, mammals, terrestrial
- phase amphibians , reptiles, and aquatic vascular plants are exceeded for the use of flutriafol as outlined in previous sections. Should estimated exposure levels occur in proximity to listed resources, the available94

baseline information may suggest a potential concern for direct effects on listed species within these taxonomic groups listed above associated with the currentl y supported uses of flutriafol.

2. Probit Dose Response Relationship 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 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 (mortality or i mmobilization) should exposure at the EEC actually occur for a species with sensitivity to the active ingredient alone and to the fraction active ingredient in the product 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 toxicity

measures of effect for each taxonomic group that is relevant to this baseline 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. In addition to a single effects probability

estimate based on the mean, upper and lower estimates of the e ffects probability

are also provided to account for variance in the slope, if available. Based on the available acute toxicity

for flutriafol TGAI and it s formulated product , a summary of the probit dose
- response anal ys is is provided in Table IV- 29
. Incases where dose
- response curves are unavailable, event probabilities are calculated for the listed species LOC based on a default slope assumption of 4.5 with 95% confidence interval of 2 and 9 as per original Agency assumptions of ty p ical slope cited in Urban and Cook (1986). Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed b y the U.S. EPA, OPP, Environmental Fate and Effects Division (Jun e 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds for that estimate) as the slope parameter for the spreadsheet. The desired threshold for the probability of an individual effect is also derived based on the calculated acute RQ, if available. For flutriafol, a probit dose response anal ys is was performed for toxicity studies with the TGAI and its formulated product for which slopes with 95% confidence intervals are available (i.e., TGAI studies with freshwater fish (sunfish), freshwater invertebrates (daphnid), estuarine/marine invertebrates (shrimp), bird oral (partridge), and bird dietary (duck) plus formulated product studies with freshwater fi sh (sunfish) and freshwater invertebrates (d aphnid). N o significant mortality was observed in acute toxicity studies with the TGAI for estuarine/marine fish (sheepshead), thus, the probit dose response analy sis was not performed for this taxon. The p robability

of an individual effect was estimated at the acute endangered species LOC for aquatic and terrestrial animals ( Table IV- 29 ). Plants and oy ster s are not included in the probability anal ys is because it is not possible to establish a relationship using continuous data. This anal ys is is presented in the following table.95

Table IV- 29 . Probit Dose Response Relationship Analysis Taxa Test

Material Acute Effect

Slope (95% C.I.) Chance of

Individual Effect at Listed Species LOC (95% C.I.) Chance of Individual

Effect at Derived Acute RQ 1 (95% C.I.) Com ment

Freshwater Fish Technical

Grade Mortality Slope

= 4.04 (2

– 6.1) 1 in 1.36E + 7

(1 in 216 to 1 in 9.6E + 14) 1 in 5.8 E+33

(1 in 1.3E+9 to 1 in 1.8E+75 ) None
%AI of product Mortality

Slope N/A = 4.5 (2

– 9) 1 in 4.2E+8

(1 in 216 to 1 in 1.8E+31) 1 in 3.5E+10

(1 in 557 to 1 in 6.4E+38) Data insufficient to allow for probit slope derivation; therefore, the default slope of 4.5 with lower and upper bounds of 2

– 9 was used. Estuarine/marine Fish Technical

Grade No significant

mo rtality observed Not calculated;

no mortality observed Not calculated; no

mo rtality observed Probit analysis not performed due to no significant mortality for e stuarine/marine fish

Freshwater Invertebrates Technical

Grade Immobilization

Slope = 5.43 ( 3.41
- 7.45 ) 1 in 1.2E+12

(1 in 2.2E+5 to 1 in 6.2E+21 1 in 2.64E+71

(1 in 9.3E+28 to 1 in 1.2E+133) None
%AI of product Immobilization

Slope N/A = 4.5 (2

– 9) 1 in 4.2E+8

(1 in 216 to 1 in 1.75E+31) 1 in 6.3E+ 9

(1 in 386 to 1 in 7.5E+35 ) Data insufficient to allow for probit slope derivation; therefore, the default slope of 4.5 with lower and upper bounds of 2

– 9 was used. Estuarine/marine Invertebrates

– shrimp Technical

Grade Mortality Slope

N/A = 4.5 ( 2
- 9 ) 1 in 4.2E+8

(1 in 216 to 1 in 1.75E+31) 1 in 2.1E+42

(1 in 1.8E+9 to 1 in 1. 0 E +165 ) The actual slope and its

95% C.I. are greater than 95% ; therefore, the default slope of 4.5 with lower and upper bounds of 2

– 9 was used.
Bird oral dose Technical

Grade 4.5 (2
- 9) 1 in 3E+5 (1 in 44 to 1 in 9E+18) 1 in 57 (1
. 8%)

(1 in 6 to 1 in 8.1E+4) The actual slope and its 95% C.I. are greater than 95% ; therefore, the default slope of 4.5 with lower and upper bounds of 2

– 9 was used. Bird dietary Technical

Grade 4.5 (2
- 9) 1 in 3E+5 (1 in 44 to 1 in 9E+18) 1 in 2.8E+11 (3.6E
12%) (1 in 862 to 1 in 2.1E+42) The actual slope and its

95% C.I. are greater than 95% ; therefore, the default slope of 4.5 with lower and upper bounds of 2

– 9 was used. As shown in Table IV- 29 , the probability for acute direct effects (mortality or immobilization) of the active ingredient to individual listed birds , freshwater fish and invertebrates, estuarine/marine fish and invertebrates at the listed species LOC range from 1 in 3E +5 (3.3E - 4 %) for birds to 1 in 1.2E +12 (8.3E - 11 %) for freshwater invertebrates . Howev er, at the highest derived RQ value for the uses of flutriafol, the chance of an individual effect for these taxa increase to approximately 1
. 8% for birds via the oral route, 3.6E - 1 0 % for birds via the dietary route , 1.7E - 32 % for freshwater fish,96

4.8E - 41 % for estuarine/marine invertebrates, and 3.8E - 70 % for freshwater invertebrates
.

3. Data Related to Under - represented Taxa Effects data from anal yz ed sources (ECOTOX Database, PAN Databas e) or registrants
- submitted studies with under
- represented taxa are not available for this baseline risk assessment.

4. Implications of Sublethal Effects Adverse effects observed in the reproduction toxicity studies with birds indicate significant effects of numerous reproduction endpoints at 97.5 mg ai/kg diet (NOAEC = 39.2 mg ai/kg diet). Effects observed in the 2
- generation study with rats indicate a reduction in body weight gains, food consumption, and on effects on the liver in parents at 1000 mg ai/kg diet (NOAEC = 240 mg ai/kg diet (20.6 mg/kg bw/day male; and 21.9 mg/kg bw/day female)); decrease in live birth index and litter size and on effects on the liver of offspring at 1000 mg ai/kg diet (NOAEC = 240 mg ai/kg diet).
c. Indirect Effects Analysis Modeled exposures for the following taxonomi c groups indicate LOC exceedances for birds consuming short grass, tall grass and broadleaf forage/small insects; consequently , there is a potential for indirect effects to listed species dependent upon birds for food, pollination or seed dispersal, or us i ng burrows or cover requirements for shelter and breeding habitat. In addition, since birds serve as the surrogate for terrestrial
- phase amphibians and reptiles, there is concern for potential indirect effects to listed species dependent on listed terrestrial
- phase amphibians and reptiles. Also, the LOC is exceeded for 15 g and 35 g mammals; there is a concern for potential indirect effects to listed species dependent on listed mammals.

d. Critical Habitat In the evaluation of pesticide effects on designated critical habitat, consideration is given to the phy sical and biological features (constituent elements) of a critical habitat identified by the U.S Fish and Wildlife and National Marine Fisheries Services as essential to the conservation of a listed species and which may require special management considerations or protection. The evaluation of impacts for a baseline pesticide risk assessment focuses on the biological features that are constituent elements and is accomplished using the baseline taxo nomic anal ys is (risk quotients, RQs) and listed species levels of concern (LOCs) that are used to evaluate direct and indirect effects to listed animals. The baseline risk assessment has identified potential concerns for indirect effects on listed species for those animals and plants dependant upon birds, mammals, terrestrial
- phase amphibians, and reptiles. In light of the potential for indirect effects, the next step for EPA and the Service(s) is to identify which listed species and critical habitat are potentially implicated. Analy

tically , the identification of such species and critical habitat can occur in either of two way s. First, the agencies could determine whether the action area overlaps critical habitat or the occupied range of any listed speci es. If so, EPA would examine whether the pesticide's potential impacts on non
-97

endangered species would affect the listed species indirectly or directl y affect a constituent element of the critical habitat. Alternatively , the agencies could determine whic h listed species depend on biological resources, or have constituent elements that fall into, the taxa that may be directly or indirectl y impacted b y the pesticide. Then EPA would determine whether use of the pesticide overlaps the critical habitat or the occupied range of those listed species. At present, the information reviewed b y EPA does not permit use of either anal ytical approach to make a definitive identification of species that are potentially impacted indirectly

or critical habitats that is pot entially

impacted directly

by the use of the pesticide. EPA and the Service(s) are working together to conduct the necessary anal ys is. This baseline risk assessment for critical habitat provides a listing of potential biological features that, if they

are constituent elements of one or more critical habitats would be of potential concern. These correspond to the taxa identified above as being of potential concern for indirect effects and include the following: birds, mammals, reptile s , and terrestrial
- ph ase amphibians. This list should serve as an initial step in problem formulation for further assessment of critical habitat impacts outlined above, should additional work be necessary
.

e. Direct Effect Co - occurrence Analysis Because the Endangered Species LOC for birds, mammals, reptiles , and terrestrial
- phase amphibians is exceeded for the proposed uses of flutriafol on apples and the endangered species LOC for birds and mammals is exceeded for soy beans, LOCATES was run for all listed birds, mammal s, reptiles, and terrestrial
- phase amphibians to determine the potential for co
- occurrence of listed animals locat ed with in areas of expected pesticide use. When baseline assessment information suggests that a listed species occurs in counties where a pesticide is used, there is a potential for a direct effect from flutriafol use, should exposure actually occur. The animal taxa that reside in those areas, and the basis for the designation, are in Appendices J and L
. Additional analy sis of listed animal lo cations, refinement of the action area associated with flutriafol regulatory

decisions, and the biology of the potentially

affected species would be needed before an effects determination can be made for any of the co
- located species identified by this ass essment. LOCATES is used to preliminarily identify areas where listed animals could be located within the counties in USA where the proposed uses for flutriafol are labeled. Consequently , based on the information available at this step in the assessment p rocess, it is presumed that all listed bird, mammal, terrestrial
- phase amphibian, and reptile specie s are potentiall y directl y affected from flutriafol uses for agricultural areas. Such potential concerns are limited by the true potential for exposures of critical resources to modeled flutriafol levels. L OCATES listed 153 endangered/threatened bird, mamm al, terrestrial
- phase amphibian , and reptile species located in areas where apples are grown. Eighty (80) endangered/threatened bird and mammal species are listed in areas where soy

beans grown nationwide. Consequently , based on the information available, it is presumed listed species reside in areas of expected pesticide use ( Table IV- 3 0 ).98

Table IV- 30 Number of Listed Species Located in Crop Areas in the Un ited States of America. Crop Affected Counties Affected States No. of Species Apples 1,6 94 48 153 Soybeans 1,665 41 80

f. Indirect Effect Co - occurrence Analysis The baseline risk quotients for birds, reptiles, mammals, aquatic vascular plants, and ter restrial
phase amphibians exceed the L OC for endangered species. In accordance with established procedures , such findings suggest a potential concern for indirect effects to listed animal and plant species with both narrow (i.e., species that are obligates or have very specific habitat or feeding requirements) and general dependencies (i.e., cover ty pe requirements) on plants or animals as a resource or important habitat component. L OCATES is used to preliminarily identify listed animal and plant species th at are located within the counties in USA where flutriafol could be used on apples and so ybeans . This analy sis considered all animal and plant taxonomic groups (i.e., conifers/cycads, monocots, dicots, ferns, lichens, mammals, insects, fish , and invertebrates) that depend on those listed animal species; terrestrial and aquatic plants that require birds and mammals as pollinators or seed dispersers; species that require mammal or reptile burrows for shelter or breeding habitats; and aquatic animals and plant s that require cover requirements. In addition, L OCATES is used to identify species that could be potentially indirectly

affected by flutriafol effects on listed species from apple and soy bean uses in counties of USA. The animal and plant species that resi de in those areas, and the basis for the designation, are in Appendices J and L and are summarized in Table IV- 3 1 , below . Such potential concerns are limited by the true potential for exposures of critical animal and plant species resources to modeled flutriafol levels and the relationship between ‘directl y a ffected’ listed species and ‘indirectly a ffected’ listed species. Consequentl y, additional analysis of listed species locations, refinement of the action area associated with flutriafol regulatory decis ions, and the biology of the potentially

affected species would be needed before an effects determination can b e made for any of the co
- located species identified by

this assessment for potential indirect effects.
Table IV - 3 1 . Listed Taxonomic Groups Po tentially at Risk for Direct or Indirect Effects as a Result of Flutriafol Applications (Applications are for Terrestrial Outdoor Uses where Apples and Soybeans are grown Nationwide). Listed Taxon Direct Effects Uses of Direct Effects

Concern Indirect

E ffects Uses of Indirect Effects

Concern Terrestrial and Semi
Aquatic Plants

– mo nocots No None Yes 3 ,4 Apple and Soybean Terrestrial and Semi
Aquatic Plants
-- dicots No None Yes 3 ,4 Apple and Soybean Terrestrial Invertebrates No None Yes 3,4 Apple and So ybean Birds and Reptiles 1 Yes Apple and Soybean 6 Yes 3,4 Apple and Soybean Terrestrial
-phase Amphibians 1 Yes Apple and Soybean 6 Yes 3,4 Apple and Soybean99

Mammals Yes Apple and Soybean 5 Yes 3,4 Apple and Soybean Aquatic Vascular Plants No Apple Yes 3,4 App le and Soybean Freshwater Fish and Aquatic
-phase Amphibians 2 No None None None Freshwater Invertebrates No None None None Estuarine/marine Fish No None None None Estuarine/marine Invertebrates No None None None Aquatic Nonvascular Plants No None Yes 3,4 Apple and Soybean 1 Birds are used as surrogate species for terrestrial
-phase amphibians and reptiles; therefore, potential direct and indirect effects to endangered avian, terrestrial
-phase amphibians and reptilian species are considered equiva lent. 2 Fish are used as a surrogate for aquatic phase amphibians; therefore, potential direct and indirect effects to endangered fish and aquatic
-phase amphibian species are considered equivalent. 3 Potential indirect effects on a taxon attributable to direct effects on birds, terrestrial
-phase amphibians and reptiles. 4 Potential indirect effects on a taxon attributable to direct effects on mammals. 5 Both soybean uses to control soybean rust and leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew
. 6 For control of leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew growing on soybeans only. C . A ssumptions, Uncertainties, Strengths and Limitations of the Flutriafol Assessment. Maximum use scenario This screening
- level risk assessment relies on labeled statements of the maximum rate of flutriafol applications, the maximum number of applications, and the shortest interval between applications. Together, these assumptions constitute a maximum use scenario and can overestimate risk. However, the maximum use scenario must be considered because it is a reflection of the allowable use of flutriafol . The frequency at which actual uses approach these maximums is dependent on the number and timing of applications, and market forces. In addition, rates of application less than the maximum rate are also considered. Lack of data on degradates There are several areas of uncertainty in the terrestrial and the aquatic species risk assessments that could potentially

cause an underestimation of risk. First, this assessment accounts only for exposure of non
- target species to the active ingredient alone , the AI in its for mulated product, and formulated product itself

, but not to its degradates. The risks presented in this assessment c ould be underestimated if degradates also exhibit toxicity under the conditions of use proposed on the label. The degradates of flutriafol were not reviewed in this assessment; however, 1,2,4
- triazole is a common degradate of all conazole pesticides and it s fate properties and toxicity will be addressed b y the Agency in a separate assessment
. Uncertainties with GENEEC 2 model Extrapolating the risk conclusions from the standard pond scenario modeled by GENEEC2 may100

either underestimate or overestimate the potential risks. Major uncertainties with the standard runoff scenario are associated with the phy sical construct of the watershed and representation of vulnerable aquatic environments for different geographic regions. The phys icochemical properties (pH, redox conditions, etc.) of the standard farm pond are based on a Georgia farm pond. These properties are likel y to be regionally specific because of local hydrogeological conditions. Any alteration in water quality parameters may impact the environmental b ehavior of the pesticide, depending upon the specific properties of a given chemical (for example, pH and dependant hydrol ys is). The farm pond represents a well
- mixed, static water body . Because the farm pond is a static water body (no flow through), it do es not account for pesticide removal through flow through or accidental water releases. However, the lack of water flow in the farm pond provides an environmental condition for accumulation of persistent pesticides. The assumption of uniform mixing does no t account for stratification due to thermoclines (e.g., seasonal stratification in deep water bodies). Additionally , the phys ical construct of the standard runoff scenario assumes a watershed:pond area ratio of 10 to 1. This ratio is recommended to maintai n a sustainable pond in the Southeastern United States. The use of higher watershed:pond ratios (As recommended for sustainable ponds in drier regions of the United States) may lead to higher pesticide concentrations when compared to the standard watershed :pond ratio. Furthermore, long range atmospheric transport is beyond the scope of either GENEEC2 or AgDRIFT assessments, and has not been considered here. Location of wildlife species For baseline terrestrial risk assessments for listed species, a generic bird or mammal is assumed to occup y either the treated field or adjacent areas receiving or ingesting pesticide at a rate commensurate with the treatment rate on the field. Model predictions suggest that this assumption leads to an overestimation of exposure to species that do not occup y the treated field
. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species occup y, exclusively and permanently, the treatment area being modeled. This assumption leads to a maximum level of exposure in the risk characterization. To the extent that a species does not reside exclusively

and permanentl y in treated areas, exposure will be less, and presumabl y less. Routes of exposure Baseline risk assessment s for granular applications of pesticides consider dietary exposure alone. Other routes of exposure, not considered in this assessment, are discussed below:

- In cidental soil ingestion exposure The baseline risk assessment does not consider incidental soil ingestion. Available data suggests that up to 15% of the diet can consist of incidentally ingested soil depending upon species and feeding strategy

(Beyer et al. 1994).

- Inhalation exposure The baseline risk assessment does not consider inhalation e xposure. Such exposure may occur through two potential sources: (1) vapor phase pesticide volatilizing from treated surfaces and (2)101

airborne particulate (soil, vegetative material, and pesticide dusts/crystals/flakes). Theoretically , inhalation of pesticide a ctive ingredient in the vapor phase may be another source of exposure for some pesticides under some exposure situations. However, considering its low vapor pressure value ( 4 x 10 - 7 mm Hg), it is unlikely that flutriafol will exist in the gaseous phase at any considerable amount to cause any adverse effects via inhalation.

- Dermal exposure The screening assessment does not consider dermal exposure, except as it is indirectly included in calculations of risk indices based on lethal doses per unit of pesti cide treated area. Dermal exposure may

occur through three potential sources: (1) direct application of flakes/crystals to terrestrial wildlife in the treated area, (2) incidental contact with contaminated vegetation, or (3) contact with contaminated water or soil. The available measured data related to wildlife dermal contact with pesticides are extremely limited. The Agency

is actively

pursuing modeling techniques to account for dermal exposure via direct application of granules and b y incidental contac t with vegetation. Dietary Intake

– The Differences between Laboratory and Field Conditions The acute and chronic characterization of risk rel y on comparisons of wildlife dietary residues with LC 50 or NOAEC values expressed in concentrations of pesticides in laboratory feed. These comparisons assume that ingestion of food items with flutriafol residues in the field occurs at rates commensurate with those in the laboratory . Although the screening assessment process adjusts dry
- weight estimates of food int ake to reflect the increased mass in fresh weight wildlife food intake estimates, it does not allow for gross energy and assimilative efficiency differences between wildlife food items and laboratory feed. On gross energy

content alone, direct comparison of a laboratory dietary concentration
- based effects threshold to a fresh
- weight pesticide residue estimate would result in an underestimation of field exposure by

food consumption by

a factor of 1.25

– 2.5 for most food items. Only for seeds would the direct comparison of dietary threshold to residue estimate lead to an overestimate of exposure. Differences in assimilative efficiency between laboratory

and wild diets suggest that current screening assessment methods do not account for a potentially import ant aspect of food requirements. Depending upon species and dietary matrix, bird assimilation of wild diet energy ranges from 23

– 80%, and mammal’s assimilation ranges from 41
- 85% (U.S. Environmental Protection Agency , 1993). If it is assumed that laboratory chow is formulated to maximize assimilative efficiency

(e.g., a value of 85%), a potential for underestimation of exposure may exist by assuming that consumption of food in the wild is comparable with consumption during laboratory

testing. In the screening process, exposure may be underestimated because metabolic rates are not related to food consumption. Finally , the screening procedure does not account for situations where the feeding rate may be102

above or below requirements to meet free
- living met abolic requirements. Gorging behavior is a possibility

under some specific wildlife scenarios (e.g., bird migration) where the food intake rate may be greatly

increased. Kirkwood (1983) has suggested that an upper
- bound limit to this behavior might be the ty

pical intake rate multiplied by a factor of 5. Use of the most sensitive species tested A small number of surrogate species are used in this baseline risk assessment. It is not possible to determine whether the species tested are more or less sensitive than species that may be exposed to flutriafol
. In addition , it is assumed that fish are approximately as sensitive as aquatic
- phase amphibians and that bird are approximately as sensitive as terrestrial
- phase amphibians and reptiles. However, no data are available to support these conclusions. Lack of field studies Although not required, field studies would assist in determining the actual extent of potential indirect effects to plants that depends on mammals and birds as pollinators and to animals that depends on reptile or mammal burrows for shelter and habitat. Age class and sensitivity of effect thresholds It is generall y recognized that test organism age may have a significant impact on the observed sensitivity

to a toxicant. The screening risk a ssessment acute toxicity data for fish are collected on juvenile fish between 0.1 and 5 grams. Aquatic invertebrate acute testing is performed on recommended immature age classes (e.g., first instar for daphnids, second instar for amphipods, stoneflies and mayflies, and third instar for midges). Acute dietary

testing with birds is performed on juveniles, with mallard being 5
- 10 days old and bobwhite quail 10
- 14 day s old. Testing of juveniles may

overestimate toxicity

at older age classes for pesticidal active ingredients because younger age classes may not have the enzymatic s ys tems associated with detoxifying xenobiotics. The baseline risk assessment has no current provisions for a generall y applied method that accounts for this uncertainty
. As far as th e 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. Acute and Chronic LOCs The risk characterization section of this assessment includes an evaluation of the potential for individual effects at an exposure level equivalent to the L OC. This evaluation is based on the median lethal dose estimate and dose/response relationship established for the effects st udy corresponding to each taxonomic group for which the L OCs are exceeded. The dose
- response curve representing a given taxa is generated from one study using one species. It is likel y that the103

resulting dose
- response relationship does not represent the re sponse of all species within a taxa. The risk estimates are based on acute and chronic effects in the laboratory ; therefore, these risk estimates do not directly

take into account uncertainties such as laboratory
- to - field sensitivity differences. These include uncertainty regarding the error introduced when extrapolating from laboratory

to field effects at a given concentration. For example, mortality in the field could be greater in populations previously stressed by

other pesticide exposures, temperature stress, habitat loss, predation, or competition for limited resources. Field mortality and reduction in growth and reproduction could be lower if the laboratory population were to represent an unusually sensitive species. REFERENCES U.S. EPA. 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances. Office of Pesti cide Programs. Washington, D.C. January 23, 2004. U.S. EPA. 2004b. Interim Guidance of the Evaluation Criteria for Ecological Toxicity Data in the Open Literature. Phases I and II. Procedures for Identifying, Selecting and Acquiring Toxicity Data Publis hed in the Open Literature for Use in Ecological Risk Assessments. Office of Pesticide Programs. July

16, 2004. U.S. EPA. 2000. Wildlife Exposure Factors Handbook. Office of Research and Development, Washington, D.C. EPA/600/R
- 93/187. December 1993. Ho erger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative data as a basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte, eds. , Environmental Quality and Safety : Chemistry , Toxicology , and Technology , Georg Thieme Publ, Stuttgart, West Germany , pp. 9
- 28. Support Document # 14. 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 p esticide residues on plants. Environ. Tox. Chem. 13:1383
- 1391.104



### Appendix A. Environmental Fate Assessment and Data Summary Flutriafol is stable to both hydrol ys is and aquatic photoly sis. Flutriafol is a fungicide that is expected to be is per sistent and moderatel y mobile in the environment, with its major routes of dissipation through biotic degradation. Flutriafol biodegrades with half
- lives of more than a year under aerobic and anaerobic, in both terrestrial and total
- sy stem aquatic environments. L aboratory anaerobic aquatic data suggests more rapid degradation in aquati c environmental compartments (t 1⁄2 = 6 weeks)
. Repeated applications may lead to accumulation of flutriafol residues in soil ; a s a result, flutriafol is expected to persist f or ye ars, and to build up with successive annual applications in both aerobic and anaerobic soil environments . D egradates of flutriafol were onl y reported in two studies, a soil photolysis study and an anaerobic aquatic metabolism study . They include 1 ,2 ,4
- triazole , triazole acetic acid , triazole alanine , 2,4’
- difluorobenzophenone , and c arbon dioxide
. No major degradation products (i.e. > 10% of applied) were identified in any water or soil studies. As indicated b y the adsorption/desorption coeffici ents, flutriafol is moderately mobile in the laboratory tested soils. This moderate potential for mobility , combined with the persistence demonstrated in laboratory metabolism half

- lives greater than one year, indicate that under some environmental conditions, flutriafol does possess the potential to reach groundwater. Flutriafol is expected to reach surface water through drift, runoff, leaching, and/or erosion ; drift and leaching are predicted to be the major contributors
. Further, the vapor pressure of flutriafol indicates that volatility is not a major route of dissipation for this chemical in the environment. Field studies were inadequate to demonstrate a potential for flutriafol to significantly leach to ground water. While sufficient data to cal culate ten half
- life values have been submitted, all test plots were located at foreign testing sites. Itwas not determined if any of these sites were comparable to domestic test sites, none of the soil samples were anal yz ed for the formation of any degradation products, and storage stability data were often absent. However, flutriafol was detected in some test sites at the 30 cm sample depth, demonstrating that flutriafol has the ability to slowly leach through the soil profile, and shows a potential to eventually reach ground water. Additionally , 6 non
- guideline terrestrial field dissipation studies, most with applications over multiple years, indicate that flutriafol residues will remain undegraded, allowing residues to carry
over from ye ar to ye ar under actual use conditions. When terrestrial field dissipation half
- lives were calculated for test plots with multi
- ye ar applications (1 to 8 years), they were on the order of ye ars. Reported carry
- over ranged from between 9% and 48% calculated with data from 2 to >8 ye ars. Amounts of flutriafol residues reported in the aquatic and sediment phases of the test sy stem at each sampling interval appear in Table A- 2 , below. Due to the length of the studies, and the persistence of flutriafol, major degradate s were not detected in either laboratory or field studies. Minor degradates of flutriafol, which were only reported in two studies, a soil photolysis study and an anaerobic aquatic metabolism study include 1 ,2,4
- triazole , triazole acetic acid , triazole al anine , 2,4’
- difluorobenzophenone , and c arbon dioxide (CO 2 ). With the exception of 1,2,4
- triazole, none of the degradates above were considered a human health concern b y the OPP Health Effects Division (HED). 1,2 ,4
- Triazole was a minor degradate in the su

bmitted studies, but is a common degradate to other fungicides. ,2,4
- Triazole has been determined to be a human health concern. 1,2,4
- Triazole is a common degradate of all105

conazole pesticides. As a result, its fate properties and toxicity will be address ed b y the Agency in a separate assessment.

Figure A - 1. Flutriafol Chemical Structure

Figure A - 2. 1.2.4 - Triazole Chemical Structure



## N N H N N N N C

H 2 

## O H F F106

Table A- 1 Physical, Chemi cal and Environmental Fate Properties of Flutriafol Physical and Chemical Properties Chemical Name (common) Flutriafol Chemical Name (CAS) α - (2
- Fluorophenyl)
- α - (4
- fluorophenyl)
- 1H
- 1,2,4
- triazole
- 1
- ethanol Chemical Abstract Number (CAS Number) 76674
- 21
- 0 Chemical Class Conazole Molecular Weight (g/mol) 301.3 Aqueous Solubility (20  C) 130 mg/L pKa Not reported. Neutral non
- dissociating . Vapor Pressure 4 x 10 - 7 Pa Henry’s Law Constant ( 20  C) 1.3 x 10 - 11 atm x m 3 x mol - 1 Octanol/water Partition Coefficient (log Kow at pH7) 2.29 Environmental Fate Properties Hydroly sis Half

- life (pH 5, 7) t 1/2 = stable Aqueous Photolysis Half
- Life t 1/2 = stable Photo degradation on Soil Half
- Life t 1/2 = 72.2 days (continuous irradiation) Aerobic Soil Metabolism Half
- Lives (total system) t 1/2 = 120, 161, 257, 84, 98, 315, 3466, 347, and 239 weeks Anaerobic Metabolism Hal f
- Lives (total system) t 1/2 = < 1day in water t 1/2 = > 365 days in total system Aerobic Aquatic Metabolism Half
- Lives t 1/2 = 42.6 days in water

t 1/2 = > 100 days in total system Soil
- Water Partitioning Coefficients (Koc) 498, 205, 379, 230, 340, 428, 140 Bioaccumulation in Fish Maximum BCF values were 6.8 for w hole fish (day 3), 4.7 for muscle tissue (day 3), and 12.2 for viscera tissue (day 21) Terrestrial Field Dissipation (total system; non
- linear) t 1/2 = 1155, 3466, 2310, 990, 408, 1733, 105, 99, 696, and 261days107

Table A - 2 : Biotransformation of [ 14 C]flutriafol, expressed as percentage of applied radioactivity (mean  s.d., n = 2).

Compound - Test System Sampling times (days posttreatment) 0 0.25 1 2 7 14 30 60 100 Flutriafol
- Unite d Kingdom stream water- sand sediment under aerobic conditions MRID 47090419 Water 94.66  0.53 84.11  4.00 83.68  0.66 77.32  4.30 67.82  1.58 52.98  1.68 36.92  3.74 21.72  0.18 19.75  0.15 Sediment 2.81 

0.47 6.36  2.95 6.74  1.12 14.11  1. 73 24.97  1.16 34.31  1.70 51.21  5.53 66.23  1.35 61.81  1.74 Total Sy stem 97.47 

1.00 90.46  1.05 90.42  1.78 91.43  2.56 92.79  0.42 87.29  0.02 88.13  1.80 87.95  1.17 81.56  1.89 Compound - Test System Sampling times (days posttreatmen t) 0 0.25 1 2 7 14 30 60 100 Flutriafol
- United Kingdom river water- silt loam sediment under aerobic conditions MRID 47090419 Water 88.18  2.28 74.79  4.65 77.73  0.42 75.77  1.75 61.58  0.71 56.00  5.20 34.52  0.88 20.91  1.95 12.86  0.56 Se diment 10.64 

2.13 12.84  1.25 11.37  1.12 16.06  2.47 27.09  0.82 35.38  4.03 55.68  0.22 71.52  2.95 75.50  0.04 Total Sy stem 98.82 

0.16 87.62  3.39 89.10  1.56 91.83  0.72 88.67  0.12 91.38  1.17 90.20  0.67 92.42  0.99 88.36  0.52 Compound - Test System Sampling times (days posttreatment) 0 7 14 30 58 90 181 272 365 Flutriafol
California pond water
- sand clay loam sediment under anaerobic conditions MRID 47090424 Water 8.4  0.0 8.4  0.7 4.4  0.0 4.4  0.2 4.7  0.2 4.5  0.0 3.3  0.1 2.3  0.4 4.6  0.1 Sediment 88.4 

0.8 78.0  0.4 86.6  0.1 85.3  0.5 83.5  1.0 83.3  1.5 79.3  0.4 78.2  2.3 83.1  1.6 Total Sy stem 96.7 

0.8 86.4  0.3 91.0  0.1 89.7  0.6 88.2  1.2 87.8  1.4 82.6  0.3 80.5  2. 7 87.7  1.7108 

### Summary of Submitted Data Hydrolysis MRID 47090416 The hydroly sis of [triazole
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity >97.3%), at a nominal test concentration of 1.0  g a.i./mL , was studied at 25  C in sterile aqueous buffered pH 5 (0.01M acetate), pH 7 (0.01M phosphate), and pH 9 (0.01M borate) solutions that were stored in the dark for up to 30 day s. The test sy stem consisted of sterilized 50
- mLErlenmeyer flasks containing treated buffer solution ( 30 mL). One flask was prepared for each pH level. Duplicate aliquots were collected from each flask at 0, 2, 8, 16, and 30 day s post treatment. Volatiles were not collected. Samples were anal yz ed as collected, without manipulation or modification, for total [ 14 C]residues using L SC. [ 14 C] Flutriafol and its transformation produ cts were isolated and quantified using TLC and identified by retention time and comparison to unlabeled reference standards. During the study , the temperature of the buffer solutions were measured at ca . 24
- hour intervals and were maintained at 25  C. The pHs of the buffer solutions showed no appreciable variation throughout the study period (<0.1 pH units). The sterility of the test solutions was not determined. Overall recoveries were 98.2  1.5% of the applied radiation. There was no pattern of los s of material over time. [ 14 C]Flutriafol was stable in the pH 5, 7, and 9 solutions. No major or minor transformation products were isolated. This study is classified as acceptable. Aqueous Photolysis MRID 47090417 The aqueous phototransformation of [triazolyl
14 C]
- and [methine
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiopurity

>96.1%), at 1.0 mg a.i./L, was studied at 25  1  C in sterile aqueous buffered pH 7 (0.01M phosphate) solution that was continuously irradiated using a UV
- filtered x enon arc lamp (280
- 420 nm) for ca . 9 day s. The intensity of the artificial light was equivalent to ca . 66 days of Florida sunshine. The test sy stem consisted of sterilized glass, water
- jacketed vessels containing treated bulk buffer solution covered wi th quartz lids and placed under the irradiation apparatus. Volatiles were trapped in 0.1M hydrochloric acid , two traps containing a mixture of ethanolamine , and 2
- ethox yethanol. Duplicate aliquots of each irradiated buffer solution were collected for analy sis at ca . 0, 8.8, and 9.6 day s; dark controls were collected at 9 day s. Samples were anal yz ed as collected, without manipulation or modification, by LSC and TLC. [ 14 C] Flutriafol and its transformation products were isolated and quantified using TLC an d identified by retention time and comparison to unlabeled reference standards
. The sterility of the test solutions was not determined. [Triazolyl
14 C]flutriafol and [methine
14 C]flutriafol were stable in the irradiated and dark control solutions. No ma

jor or minor transformation products were isolated. This study is classified as acceptable.109

MRID 47090418 The quantum yield of unlabeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- yl methyl)benzhydryl alcohol (flutriafol; purity 98.8%), at a measured con centration of 25.72 mg a.i./L , was studied in pure water and irradiated continuously using a Xenon high stability short arc lamp for 5 hours at 20  C. Nine irradiated samples and ten dark control samples were collected from the bulk solutions after 5 hours of irradiation . Identification of flutriafol was confirmed using HPL C. Flutriafol was identified by comparison to an external reference standard. Sterility

checks and pH measurements were not performed. Mass balances were not determined. The amount o f light absorbed b y flutriafol in units of mEinstein was determined using a QuantaCount. . The quantum yield of flutriafol was determined from the number of mmol of flutriafol photoly

zed divided by

the number of mEinstein of light it absorbed. After 5 h ours of irradiation, an absorption of 1,501,800 “counts” of light were measured (equivalent to 7.06 x 10 - 4 mEinstein). The quantum yield was determined to be zero since there was no measurable photodegradation. Based on HPL C anal ys is, the apparent loss o f flutriafol due to photoly sis was 0.4%, which is a decrease in concentration of 0.1 mg/L after 5 hours of irradiation. Based on these results, the study author concluded that the irradiation of flutriafol did not result in a significant decrease in the initial test concentration. The study author determined that because the quantum yield for photoly sis of flutriafol in pure water is zero, degradation of flutriafol in the environment as a result of the direct absorption of sunlight will not be a significant process. This study is classified as supplemental. This was a quantum yield study , meant to supplement Subdivision N guidelines Soil Photolysis MRID 47090420 The phototransformation of [triazole
14 C] and [carbinol
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - ( 1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity  98%) was studied on sandy loam soil (pH 7.25, organic matter 4.27%) from England under artificial light for 7 day s or natural sunlight for 30 day s . Flutriafol was applied to the soil at the proposed application rate of 94 g a.i./ha. The samples were irradiated using alternating “sunlight” ultraviolet and “black light” lamps for 7 day s. The intensity

of the lamp and a comparison of the artificial light source to natural sunlight were not provided. Samples were also irradiated under natural sunlight in Berkshire, England from May 18 to June 17, 1982. The test sy stem consisted of soil
- covered glass plates that were air
- dried and treated with [ 14 C]flutriafol. The artificial light plates were placed into borosilicate glass test tubes that were continuously rotated on a merry
- go - round accessory located within the photochemical reactor. Dark controls were not employed. The natural sunlight plates were placed into quartz gla ss conical flasks and placed outside in an unshaded location. Dark control plates were placed into quartz glass conical flasks wrapped in110

aluminum foil. Irradiated samples were collected at 0, 1, 4, and 7 days posttreatment for the artificial light plate s and irradiated samples and dark controls were collected at 30 day s posttreatment for the natural sunlight plates. Soils were extracted twice with acetonitrile and twice with acetonitrile:water. The soil extracts and extracted soils were anal yz ed for to tal radioactivity using LSC. Flutriafol and its transformation products were isolated and quantified using TLC and identified by comparison to unlabeled reference standards of flutriafol and five possible transformation products. Meaningful half

- lives fo r flutriafol under artificial light conditions could not be determined because data were provided for onl y two sampling intervals; under natural sunlight conditions data were provided for only one sampling interval. This study is classified as supplemental. Meaningful half

- lives could not be determined because of inadequate sampling intervals. The incubation temperature used during both experiments was not reported. A comparison of the artificial light source to natural sunlight was not reported, and th e light/dark photoperiod was not reported. For the artificial light samples, the study was terminated after only 7 day s of irradiation, at which time 70.4
- 76.5% of the applied [ 14 C]flutriafol remained undegraded in the soil. Results Synopsis Label: Triazole. Soil ty pe: Sandy loam soil. Source of irradiation: Alternating “sunlight” ultraviolet and “black light” lamps. Half
- life for Dark: Not applicable. Half
- life for Irradiated: Not determined. Major and minor transformation produc ts/dark: Not applicable. Major transformation products/irradiated: None. Minor transformation products/irradiated: 1H
- Triazole (Compound IV). Source of irradiation: Sunlight. Half
- life for Dark: Not determined. Half
- life for Irradiated: Not determined. M ajor and minor transformation products/dark: Not reported. Major transformation products/irradiated: None. Minor transformation products/irradiated: 1H
- Triazole (Compound IV).
Label: Carbinol. Soil ty pe: Sandy loam soil. Source of irradiation: Alternating “sunlight” ultraviolet and “black light” lamps. Half
- life for Dark: Not applicable. Half
- life for Irradiated: Not determined. Major and minor transformation products/dark: Not applicable. Major transformation products/irradiated: None. Minor transformation products/irradiated: Difluorobenzophenone (Compound VI).111

Source of irradiation: Sunlight. Half
- life for Dark: Not determined. Half
- life for Irradiated: Not determined. Major and minor transformation products/dark: Not reported. Major transformation products/irradiated: None. Minor transformation products/irradiated: Difluorobenzophenone (Compound VI). MRID 47 418401 The phototransformation of [ 14 C
- triazole ]
- and [ 14 C
- carbinol ]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity 99.3% and 98.7%), was studied on sandy clay loam soil (pH 7.0, organic carbon 1.3%) from California irradiated under artificial light for 312.5 hours ( ca . 1 3 day s)
. Flutriafol was applied to the soil at an actual application rate of 1.02
- 1.0 6 mg a.i./kg soil. The samples were continuously irradiated using a filtered xenon arc lamp (300
- 800 nm) for 312.5 hours ( ca . 13 day s), which was equivalent to 31
- 32 day s of natural summer sunlight at 40°N
. The test s ys tem consisted of thin air
- dried soil layers treated with [ 14 C]flutriafol in quartz dishes (50 mm diameter) equipped with a side arm
. The dishes were submerged in a continuously

circulating water bath and placed beneath the xenon lamp. Humidified air was drawn over the soil in the sample dishes and passed through a volatile trapping s ys tem. The dark controls were prepared in P yrex dishes that were wrapped in aluminum foil and plac ed in an incubator in the dark. Duplicate irradiated samples and dark controls (triazole label only) were collected at 0, 26, 71.3, 144.5, 221.6, and 312.5 hours
. Soil samples were extracted three to four times with acetonitrile:water. The combined soil extracts, volatile trapping solution s, and extracted soils following combustion were anal yz ed for total radioactivity

using LSC
. [ 14 C] Flutriafol and its transformation products w ere anal yz ed using reverse
- phase HPLC and identified by comparison to unlabeled reference standard s, with the identification confirmed using one - and two
- dimensional TL C . Selected nonextractable residues were partitioned into humin, humic acid and fulvic acid fractions and anal yz ed b y LSC. Since flutriafol in the dark controls were stable, the p hototransformation half
- life for [ 14 C] flutriafol is equivalent to the half
- life observed in the irradiated samples. Based on first
order linear regression analy sis , the phototransformation half - life of flutriafol (combined labels) is 1,732.9 hours (72.2 d ay s), based on the length of continuous light exposure used in the study . This half

- life is of uncertain value since it is extrapolated beyond the duration of the study ( ca . 13 day s). For the irradiated samples of both labels, flutriafol decreased from an average of 94.2
- 94.8% of the applied at time 0 to 78.8
- 81.2% at 312.5 hours (study termination). No transformation products were identified from either the irradiated soil or the dark controls; average maximum s of residues were no greater than 5. 8 %
. This study

is classified as supplemental , because the study was terminated before the half
- life of the test material was established. No significant deviations from good scientific practices were noted. However, no additional information would be ob tained b y repetition of this study . The study provides sufficient information to predict that flutriafol will be stable to photolysis on soil surfaces.112

Results Synopsis Soil ty pe: S andy cl ay loam soil. Source of irradiation: Xenon arc lamp. Triazole label Half
- life for Dark: Stable. Half
- life for Irradiated: 1,386 hours (r2 = 0. 7432 ). No major transformation products were isolated in the irradiated samples. Minor transformation products/ irradiated: CO 2 . No major or minor transform ation products were isolated in the dark control samples. Carbinol label Half
- life for Dark: Not determined. Half
- life for Irradiated: 2,310.5 hours (r2 = 0. 5437 ). No major transformation products were isolated in the irradiated samples. Minor transformation products/ irradiated: CO 2 . Dark controls were not used for the Carbinol label
. Aerobic Soil Metabolism MRID 47090421 The biotransformation of [triazole
- 3,5
- 14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol, radiochemical purity 99.9% ) was studied in a sandy

loam soil from North Dakota for 365 day s under aerobic conditions in darkness at 25  1  C and a soil moisture content of 75% o f the water holding capacity
. [ 14 C]Flutriafol was applied at a rate of 1.04 mg a.i./kg, which was reported to be equivalent to 1 kg a.i./ha. The test s ys tem consisted amber glass bottles containing moistened treated soil that were connected to individual flow
- through volatile trapping s ys tems. Moistened, CO 2 - free air was continuously

forced through a sample bottle, then through one vial of ethylene gl yc ol to collect organic volatiles and two vials of 10% NaOH to collect CO 2 . Duplicate samples were colle cted at 0, 7, 14, 29, 61, 91, 180, 271 and 365 day s posttreatment. The soil was extracted with acetonitrile:water , once by shaking and once by

overnight Soxhlet extraction. Aliquots of the individual extracts were anal yz ed using LSC. The shaking and Soxhlet extracts were combined, and aliquots were anal yz ed using LSC and HPL C. Flutriafol and its transformation compounds were identified by comparison to unlabeled reference standards. Identification of flutriafol was confirmed using TLC. Aliquots of the volatile trapping solutions were anal yz ed using L SC. The extracted soil was anal yz ed using L SC following combustion. The temperature , aerobicity and moisture content of the soil were reportedly maintained throughout the experiment. Treated soil was s hown to be viable throughout the study . There was no pattern of decline over time. No major transformation products were isolated and no minor transformation products were identified. Based on the study results, flutriafol is relativel y stable in aerobi c soil, degrading to several very

minor components, CO 2 and bound residues over a period of decades. This study is classified as supplemental.113

Results Synopsis: Test system used: Sandy loam soil. Linear half

- life: 6,932 day s (r2 = 0.4187). Nonlinear half

- life: 6,932 day s (r2 = 0.9996). Observed DT 50 : >365 day s. Major transformation products: No major transformation products were isolated. Minor transformation products: CO 2 . MRID 47090422 The biotransformation of [triazole
- 3,5
- 14 C]
- and [carbinol
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol, radiochemical purity 99%) was studied in six soils all from the United Kingdom.

 a sandy clay loam soil (18 Acres, pH 6.8, organic matter 4. 7
- 4.9%);
 a coarse sandy loam/loamy coarse sand soil (Frensham, pH 5.7
- 5.8, organic matter 1.8
- 2.3%);
 a sandy clay loam soil (Flexford, pH 5.6, organic matter 4.4%);
 a sandy loam soil (Horsley, pH 6.5, organic matter 2.7%);
 a clay soil (Boxford, pH 7.7 , organic matter 4.3%) and
 a sandy clay loam soil (Chalgrove, pH 6.4, organic matter 3.7%) Multiple experiments were conducted. It was not stated whether any guidelines were used to design the study protocol. The submitter did not know if the study wa s conducted according to any GLP standards. In one experiment, the 18 Acres and Frensham soils were treated with [triazole
- 3,5
- 14 C]flutriafol at 96 g a.i./ha and incubated for 36 weeks under aerobic conditions in darkness at 20  1  C and a soil moisture content of 40% of the water holding capacity. The test system consisted of glass pots containing moistened treated soil. Like samples were placed inside a glass cylinder and connected to a volatile trapping s ys tem. Moistened, CO 2 - free air was continuou sly drawn through 0.05M H 2 SO 4 , 2
- methoxyethanol, and ethanolamine solutions. In a companion experiment, the Flexford, Horsley , Boxford, and Chalgrove soils were treated with [triazole
- 3,5
- 14 C]flutriafol at 84 g a.i./ha and incubated for 18 weeks as described. Samples of the 18 Acres and Frensham soils were treated with [carbinol
14 C]flutriafol at 95 g a.i./ha and incubated as described. The volatile trapping s ys tem consisted only of the ethanolamine solutions. Single pots of each soil were collected at 0, 3, 9, and 18 weeks posttreatment, with the exceptions that the 18 Acres and Frensham soils were also collected at 36 weeks. Volatiles were collected at each sampling interval. The time 0 soil samples were extracted twice by refluxing114

with acetonitrile:water for 1 and then 2 hours. Samples collected after time 0 were Soxhlet
extracted twice with acetonitrile:water for 18 hours/extraction. The soil extracts and volatile trapping solutions were analyzed for total radioactivity using LSC. The soil e xtracts were anal yz ed b y one - dimensional TL C. Flutriafol was identified by comparison to an unlabeled reference standard. The extracted soil was anal yz ed using LSC following combustion. For the flooded soil, the water layer was removed prior to soil extraction and analyzed using L SC and TL C; the soil was analyzed as described. Recoveries were variable, but there was no pattern of decline over time in any soil. In all six soils, flutriafol was relatively stable under the conditions of the study . Volati le [ 14 C]organics were reported as not significant. Additional experiments in which the temperature, moisture content, aerobicity or application rate were varied were conducted using 18 Acres soil. In all experiments , [ 14 C]flutriafol was stable to relati vel y stable. This study is classified as supplemental. Except for CO 2 , no minor transformation products were identified. Additionally , it could not be determined if the British soils used in this study

are comparable to soils found in a ty pical flutriaf

ol use area in the United States. Results Synopsis: Test system used: 18 Acres sandy clay loam soil (triazole plus carbinol labels). Linear half

- life: 120 weeks (r2 = 0.5273). Nonlinear half

- life: 116 weeks (r2 = 0.9962). Observed DT 50 : >36 weeks. Test system used: Frensham coarse sandy loam/loamy coarse sand soil (triazole plus carbinol labels). Linear half

- life: 161 weeks (r2 = 0.5036). Nonlinear half

- life: 158 weeks (r2 = 0.9978). Observed DT 50 : >36 weeks. Test system used: Fl exford sandy clay loam soil. Linear half

- life: 257 weeks (r2 = 0.2306). Nonlinear half

- life: 257 weeks (r2 = 0.9988). Observed DT 50 : >18 weeks. Test system used: Horsley sandy loam soil. Linear half

- life: 84 weeks (r2 = 0.8546). Nonlinear half

- life: 86 we eks (r2 = 0.9994). Observed DT 50 : >18 weeks. Test system used: Boxford clay soil. Linear half

- life: 98 weeks (r2 = 0.8702). Nonlinear half

- life: 98 weeks (r2 = 0.9996). Observed DT 50 : >18 weeks. Test system used: Chalgrove sandy clay loam soil.115

Linear half

- life: 315 weeks (r2 = 0.1015). Nonlinear half

- life: 301 weeks (r2 = 0.9979). Observed DT 50 : >18 weeks. All soils: Major transformation products: No major transformation products were isolated. Minor transformation products: CO 2 . MRID 47090423 The b iotransformation of nonradiolabeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol, purity not reported) was studied in three European standard soils:

 Speyer 2.2 sand (pH 6.2, organic matter 3.6%) from Germany ,  Speyer 2.3 sand (pH 7.5, organic matter 1.5%) fro m Germany and
 Warfield loamy

sand soil (pH 5.7, organic matter 3.5%) from the United Kingdom, for 52 weeks under aerobic conditions in darkness at 20  C and a soil moisture content of 40% of the water holding capacity. [ 14 C]Flutriafol was applied at a rate of 1 mg a.i./kg, equivalent to a field rate of ca. 1 kg a.i./ha. The test s ys tem consisted conical flasks containing moist treated soil that were stoppered with cotton wool. Volatiles were not collected. Duplicate flasks were collected at 0, 2, 4, 6 , 8, 16, 32 and 52 weeks posttreatment. The soil was extracted by refluxing with acetonitrile:pH 9 water. The soil extracts were partitioned with ethylacetate and purified by adsorption chromatography , then analyzed for flutriafol using gas
- liquid chrom atography with nitrogen selective detection. The extracted soil was not analyzed. The temperature, soil aerobicity and soil moisture content were reportedly maintained throughout the experiment. The samples were anal yz ed only for flutriafol. A material balance could not be determined. Flutriafol was relativel y stable under the conditions of the study . This study is classified as supplemental. Insufficient details about the study methods and materials were provided to allow a critical evaluation of the experiment. Samples were anal yz ed only for flutriafol. Transformation products and other residues were not quantified , and there was no material balance. Results Synopsis: Test system used: Speyer 2.2 sand soil from Germany. L inear half

- life: 3,466 weeks (66.5 ye ars; r2 = 0.0197). Nonlinear half

- life: Stable. Observed DT 50 : >52 weeks. Test system used: Speyer 2.3 sand soil from Germany. Linear half

- life: 347 weeks (6.7 ye ars; r2 = 0.5134). Nonlinear half

- life: 433 weeks (8.3 ye ars; r2 = 0.9992).116

Observed DT 50 : >52 weeks. Test system used: Warfield loamy sand soil from the United Kingdom. Linear half

- life: 239 weeks (4.6 ye ars; r2 = 0.9200). Nonlinear half

- life: 239 weeks (4.6 ye ars; r2 = 0.9998). Observed DT 50 : >52 weeks. Al l soils: Major and minor transformation products were not determined. Anaerobic Soil Metabolism MRID 47090424 The biotransformation of [triazole
- 3,5
- U
14 C]
- labeled (RS)
- 2,4 ′
- difluoro
α - (1H
- 1,2,4
- triazol
- 1
- yl methyl)benzhydryl alcohol (flutriafol; radioch emical purity 99.9% ) was studied in pond water
- sandy clay loam sediment sy stems from California for 365 day s under anaerobic conditions in darkness at 25  1  C. Based on the water volume, [ 14 C]flutriafol was applied at a rate of 0.75 mg a.i./L. The sedim ent:water ratio was ca . 1:1.4 . For the time 0 sy stems, the test apparatus consisted of sealed, 250
- mLamber bottles. For all other intervals, the test apparatus consisted of 250
- mLtwo - chambered biometer flasks with 10% NaOH in the side
chamber to trap C O 2 and a poly urethane foam plug in the connecting side
- arm to trap organic volatiles. To generate anaerobic conditions, the water
- sediment s ys tems were pre - incubated in the sealed flasks for >14 day s prior to treatment and the test solution applied under nitrogen atmosphere. Following treatment, duplicate flasks were collected after 0, 7, 14, 30, 58, 90, 181, 272 and 365 day s of incubation. Water layers were separated from sediment by centrifugation, decanted, filtered and analyzed directly . Sediment samples were extracted once with acetonitrile:water via shaking, followed b y an overnight Soxhlet extraction using the same solvent . Resulting e xtracts were combined, filtered and concentrated under nitrogen. Water layers, sediment extracts, extracted sedi ment and trapping materials were analyzed for total radioactivity

using LSC. Water layer and sediment extract samples were analyzed for flutriafol and its transformation products via reverse
- phase HPL C. In addition to parent flutriafol, reference standards of possible transformation products 1,2,4
- triazole
- 1
- alanine, 1,2,4
- triazole
- 1
- acetic acid and 1,2,4
- triazole were available for identification purposes. Identification of parent [ 14 C]flutriafol was confirmed via one
- dimensional, normal
- phase TLC again st reference standard. The test conditions presented in the study appear to have been maintained throughout the 365
- day incubation. Conditions in the treated s ys tems were strongl y reducing to moderatel y reducing with average redox potentials of
- 88  86 mV at the water
- sediment interface; dissolved oxygen and pH levels averaged 0.79  0.71 mg/L and 8.15  0.62, respectivel y. Following application of [ 14 C]flutriafol to the water layer, [ 14 C]residues rapidly partitioned from the water layer to the sediment with only 8.4% of the applied detected in the water layer at time 0; mean distribution ratios (water:sediment) were 1:9
- 11 at 0
- 7 day s and 1:  14 thereafter. Formation of 14 CO 2 and volatile [ 14 C]organic compounds were negligible at any interval.117

Flutriaf ol was relativel y stable in the total sy stem, with dissipation occurring though rapid translocation from the aqueous phase to the sediment and only minor formation of several nonvolatile products, bound sediment residues, CO 2 and volatile organic compounds
. C alculated half
- lives were not determined. No major transformation products were detected, and onl y trace amounts (  0.5% of applied) of three minor products were identified in the water layer. This study is classified as acceptable. Results Synopsis: Test system used: Pond water - sandy clay loam sediment from California. Linear half

- life in water: ND (not determined). Linear half

- life in sediment: ND. Linear half

- life in the total sy stem: ND. Non
- linear half

- life in water: ND. Non
- linear half

- life in sediment: ND. Non
- linear half

- life in total sy stem: ND. Observed DT 50 in water: <1 day
. Observed DT 50 in sediment: >365 day s. Observed DT 50 in total system: >365 day s. Major transformation products: No major transformation p roducts were isolated. Minor transformation products: 1,2,4
- Triazole
- 1
- alanine (maximum 0.5% of applied in water layer). 1,2,4
- Triazole
- 1
- acetic acid (maximum 0.3% in water layer). 1,2,4
- Triazole (maximum 0.1% in water layer). CO 2 (maximum 0.7% of applied)
. Volatile organics (maximum 0.1% of applied). Aerobic Aquatic Metabolism MRID 47090419 The biotransformation of [triazole
- 3,5
- 14 C]
- labeled (RS)
- 2,4 ′
- difluoro
- α - (1H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity  99.5% ) was studied in stream water
- sand sediment and river water
- silt loam sediment sy stems from the United Kingdom for 100 day s under aerobic condition s in darkness at 20  2  C. Based on the theoretical water volume, [ 14 C]flutriafol was applied at a rate of ca . 0.43 mg a.i./L. The test apparatus consisted of cylindrical, glass vessels connected to a continuous flow
- through s ys tem with traps for the col lection of CO 2 and volatile organics. Sediment and water were pre
incubated 37 day s, then, following treatment, duplicate vessels per s ys tem ty pe were collected after 0, 0.25, 1, 2, 7, 14, 30, 60 and 100 day s of incubation. Water layers were drawn off vi a pipette and concentrated by rotary evaporation for TL C analy sis. Sediment samples were Soxhlet
- extracted twice with acetonitrile, followed by acetonitrile:water; resulting extracts were118

combined and concentrated via rotary evaporation for TL C anal ys is. Water layers, sediment extracts, extracted sediment, trapping solutions and incubation vessel rinses were anal yz ed for total radioactivity

using LSC. Water layer and sediment extract samples were anal yz ed for flutriafol and its transformation products vi a normal
- phase, one
- dimensional TL C using two solvent sy stems. Onl y one reference standard , flutriafol , was used for identification purposes. The test conditions were moderatel y reducing to strongl y oxidizing in the water layers and primarily reducing to moderatel y reducing in the sediments with mean redox potentials of +306  102 mV and +23  75 mV. Dissolved oxygen and pH in the water layers averaged 69  20% and 7.71  0.33. There were no significant losses nor consistent patterns of decline in rec overies of applied radiolabeled material during the course of the study. Overall partitioning of [ 14 C]residues between the water layers and sediments was similar for the two s ys tems. Following application of [ 14 C]flutriafol to the water layer, [ 14 C]resid ues partitioned from the water layer to the sand. Formation of 14 CO 2 and volatile [ 14 C]organic compounds were negligible at any interval. Flutriafol gradually

translocated from the water layers to the sediments during the incubation, but overall dissipation from the total sy stems was very slow. For both sediments and total sy stems, flutriafol observed DT 50 values were >100 day s. Consequently , calculated half
- lives were not determined. No major nonvolatile transformation products were detected, and no minor products were identified. Flutriafol slowly dissipated in the total sy stem, with primary dissipation occurring though gradual translocation from the aqueous phase to the sediment, and only minor formation of several nonvolatile products, bound sediment residues, CO 2 and volatile organic compounds. This study

is classified as supplemental
. No attempt was made to identify potentially

toxic minor degradation products of flutriafol. Results Synopsis: Test system used: Stream wa ter - sand sediment from the United Kingdom. Linear half

- life in water : 42.6 day s (r2 = 0.8891). Linear half

- life in sediment: ND (not determined). Linear half

- life in the total sy stem: ND. Non
- linear half

- life in water : 27.9 day s (r2 = 0.9374). Non
- line ar half

- life in sediment: ND. Non
- linear half

- life in total sy stem: ND. Observed DT 50 in water: ca . 20 day s. Observed DT 50 in sediment: >100 day s. Observed DT 50 in total system: >100 day s.119

Major transformation products: No major transformation products were isolated. Minor transformation products: CO 2 (maximum 0.56% of applied)
. Volatile organics (maximum 0.02% of applied). Test system used: River water - silt loam sediment from the United Kingdom. Linear half

- life in water : 36.3 day s (r2 = 0.9610). Lin ear half

- life in sediment: ND. Linear half

- life in the total sy stem: ND. Non
- linear half

- life in water : 28.4 day s (r2 = 0.9592). Non
- linear half

- life in sediment: ND. Non
- linear half

- life in total sy stem: ND. Observed DT 50 in water : ca . 18 day s. Obser ved DT 50 in sediment: >100 day s. Observed DT 50 in total system: >100 day s. Major transformation products: No major transformation products were isolated. Minor transformation products: CO 2 (maximum 0.15% of applied). Volatile organics (maximum 0.01% of a pplied). Adsorption/Desorption MRID 47090425 The adsorption/desorption characteristics of [tri az ole
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol) were studied in a sandy loam soil and a clay

loam soil, each from North Dakota, in a batch equilibrium experiment. The adsorption phase of the study was carried out b y equilibrating soil with [ 14 C]flutriafol at nominal test concentrations of 0.25, 2.5, 4.5, 11.5, and 24.5 mg a.i./kg soil, in the dark at 25  C f

or 24 hours. The equilibrating solution used was 0.01M CaCl 2 solution with a soil solution ratio of 1:5 for all soils. The desorption phase of the study was carried out b y replacing the adsorption solution with an equivalent volume of 0.01M CaCl 2 solutio n and equilibrating in the dark at 25  C for 24 hours. A single desorption step was performed for each test soil. The supernatant solutions after adsorption and desorption were separated by centrifugation, and anal yz ed for total radioactivity using LSC. Following the desorption phase, high
- dose soils were extracte d twice with acetonitrile:water , and anal yz ed for total radioactivity using L SC. The radioactivity

in the soil residue after desorption was determined by combustion. Aliquots of the high
- dose adsorption and desorption supernatants and soil extracts were analyzed for [ 14 C]flutriafol using HPLC.120

The experimental temperature emplo yed during the study was reported to be maintained at 25  C. This study

is classified as supplemental. The study was co nducted using only two soil ty

pes. However, when the mobility values reported in this study are combined with the values from the other submitted mobility

study , MRID Number 47090426, the mobility data requirement for flutriafol is satisfied. Results Synopsis: Soil ty pe: Sandy loam. Amount adsorbed: 36.3
- 63.0% of the applied. Adsorption Kd : 3.7 Adsorption Koc : 264 Freundlich adsorption Kd : 3.2 Freundlich adsorption Koc : 230 Amount desorbed: 30.6
- 47.5% of the adsorbed. Deso rption Kd : Not reported. Desorption Koc : Not reported. Freundlich desorption Kd : 3.9 Freundlich desorption Koc : 279 Soil ty pe: Clay loam. Amount adsorbed: 75.1
- 101.6% of the applied. Adsorption Kd : 13.6 Adsorption Koc : 340 Freundlich adsorption Kd : 11.1 Freundlich adsorption Koc : 278 Amount desorbed: 14.9
- 29.8% of the adsorbed. Desorption Kd : Not reported. Desorption Koc : Not reported. Freundlich desorption Kd : 14. 5 Freundlich desorption Koc : 361 MRID 47090426 The adsorption/desorption charac teristics of [triazole
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol) were studied in a loamy sand soil and a clay

loam soil, each from France, in a batch equilibrium experiment. The adsorption phase of the study was carried out by

equilibrating air
- dried soil with [ 14 C]flutriafol at nominal test concentrations of 0.095, 0.49, 0.975, 4.9, and 9.7 mg a.i./kg soil, in the dark at 20  2  C for 24 hours. The equilibrating solution used was 0.01M CaCl 2 solution with a soil solution ratio of 1:5 for al l soils. The desorption phase of the study was carried out by

replacing the adsorption solution with an equivalent volume of 0.01M CaCl 2 solution and equilibrating in the dark at 20  2  for 48 hours. A single desorption step was performed for each test soil. The supernatant solutions after adsorption and desorption were separated by centrifugation, and were anal yz ed for total radioactivity using LS C. Following the desorption phase, high
- dose soils were extracted three times with acetonitrile:water, and anal yz ed for total radioactivity using121

LSC. The radioactivity

in the soil residue after desorption and extraction was determined by combustion. Aliquots of the high
- dose adsorption and desorption supernatants and soil extracts were anal yz ed for [ 14 C]flutriafol using HPLC. This study is classified as supplemental. Itcould not be determined if the foreign test soils were comparable to soils found in ty pical use areas in the United States. Mass balances were determined for high
- dose soils only. The stu dy was conducted using only

two soil ty

pes. However, when the mobility values reported in this study are combined with the values form the other submitted mobility study , MRID Number 47090425, the mobility

data requirements for flutriafol are satisfied. Results Synopsis: Soil ty pe: Loamy s and. Amount adsorbed: 66.3
- 71.6% of the applied. Adsorption Kd : 10
. 6 Adsorption Koc : 428 Freundlich adsorption Kd : 9. 8 Freundlich adsorption Koc : 395 Amount desorbed: 23.3% of the adsorbe d (high
- dose onl y)
. Desorption Kd : Not reported. Desorption Koc : Not reported. Freundlich desorption Kd : 13. 7 Freundlich desorption Koc : 553 Soil ty pe: Clay loam. Amount adsorbed: 53.4
- 61.1% of the applied. Adsorption Kd : 6.5 Adsorption Koc : 140 F reundlich adsorption Kd : 5.8 Freundlich adsorption Koc : 123 Amount desorbed: 33.5% of the adsorbed. (high
- dose onl y)
. Desorption Kd : Not reported. Desorption Koc : Not reported. Freundlich desorption Kd : 7.3 Freundlich desorption Koc : 156 MRID 4709042 7 The adsorption/desorption characteristics of [triazole
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol) were studied in a loamy sand soil and a loam soil, each from England; and a silt loam soil from France, in a batch equilibrium experiment. The adsorption phase of the study was carried out by

equilibrating air
dried soil with [ 14 C]flutriafol at nominal test concentrations of 0.25, 0.5, 2, 5, and 10 mg a.i./kg soil, at 20  2  C for 24 hours. The equilibrating solution used was 0.01M CaCl 2 solution with a soil solution ratio of 1 :10 for all soils. The desorption phase of the study was carried out b y replacing the adsorption solution with an equivalent volume of 0.01M CaCl 2 solution and equilibrating at 20  2  for 24 hours. Three desorption steps were performed for each test so il.122

The supernatant solutions after adsorption and each desorption step were separated b y centrifugation, and were anal yz ed for total radioactivity using LSC. Following the third desorption step, high
- dose Bayonvillers silt loam soils were extracted thre e times with acetone, and anal yz ed for total radioactivity using LS C. The radioactivity in the soil residue after extraction was determined by combustion. Aliquots of the high
- dose Bayonvillers silt loam desorption supernatants and soil extracts were an alyz ed for [ 14 C]flutriafol using TLC. The experimental temperature emplo yed during the study was reported to be maintained at 20  2  C
. [ 14 C]Flutriafol was stable in high
- dose Bayonvillers silt loam desorption supernatants and soil extracts following th e third desorption step, comprising  96.5% of the total radioactivity in the samples. Mass balances for soils at the end of the adsorp tion phase were not reported. This study is classified as supplemental. The study was conducted using only three soil typ es. It could not be determined if the foreign test soils were comparable to soils found in ty pical use areas in the United States. Material balances were not provided for all test soil/test concentration combinations. Results Syn opsis: Soil ty pe: Lillyfield loamy sand. Amount adsorbed: 11.7
- 18.8% of the applied. Adsorption Kd : 2.0 Adsorption Koc : 498 Freundlich adsorption Kd : 1.3 Freundlich adsorption Koc : 295 Amount desorbed: Not reported. Desorption Kd : 4.7 Desorption Koc : 1048 Freundlich desorption Kd : Not reported. Freundlich desorption Koc : Not reported. Soil ty pe: Bayonvillers silt loam. Amount adsorbed: 14.8
- 20.4% of the applied. Adsorption Kd : 2. 5 Adsorption Koc : 205 Freundlich adsorption Kd : 1.9 Freundlic h adsorption Koc : 157 Amount desorbed: 90.9% of the adsorbed. (high
- dose onl y)
. Desorption Kd : 4.2 Desorption Koc : 353 Freundlich desorption Kd : Not reported. Freundlich desorption Koc : Not reported. Soil ty pe: Hyde Farm loam. Amount adsorbed: 35. 7
- 44.0% of the applied. Adsorption Kd : 7.2 Adsorption Koc : 379123

Freundlich adsorption Kd : 5.7 Freundlich adsorption Koc : 304 Amount desorbed: Not reported. Desorption Kd : 10.9 Desorption Koc : 588 Freundlich desorption Kd : Not reported. Freundlich deso rption Koc : Not reported. MRID 47090428 The adsorption partition coefficients of flutriafol were determined for 16 European soils: four sandy loam soils, four sandy clay loam soils, three clay

soils, two organic clay soils, and a lo amy sand soil, each from the United Kingdom, and a clay loam and a silt loam, each from Germany . For each test soil, control and treated soil samples were collected from a series of trials in which flutriafol was applied at 0.19
- 0.25 kg a.i./ha/year annually for 9 ye ars or at 0, 2, and 4 kg a.i./ha in a single dose at 3 years prior to sampling. The study was submitted under US EPA OPP Guideline 163
- 1 . H owever, the guidance used to design the study protocol was not identified. This study was designed to evaluate the effect of time on the adsorption properties of flutriafol in soil. As such, the study was not designed as a typical batch equilibrium or column leaching study
. The test soils were dried and sieved prior to use. For the soils from the treated plots, duplicate aliquots were added to Teflon tubes with sealing caps. Aliquots of 0.01M CaCl 2 solution were added and the samples were thoroughl y shaken and continuously mixed on an end
- over- end shaker at 20  1  C. For the soils from the untreat ed plots, duplicate aliquots were pre
equilibrated with 0.01M CaCl 2 solution in Teflon tubes, then fortified with flutriafol which had been dissolved in methanol, at test concentrations of 100  g/mL and 1000  g/mL. The samples were thoroughl y shaken and c ontinuously mixed on an end
- over- end shaker at 20  1  C. After 24 hours, all samples were centrifuged and aliquots of the supernatants were stored frozen at
- 15  2  C. For the “aged residues” samples, aliquots of the soils were extracted b y refluxing in acetonitrile:pH 9 water. The extracts were cleaned up by liquid/liquid partition and adsorption chromatography on Florisil. Aliquots were anal yz ed for flutriafol using a gas chromatograph fitted with a nitrogen selective thermionic detector and the inter nal standardization technique. For the “freshl y applied” samples, the thawed 24
- hour aqueous supernatants were passed through a bonded phase C 18 silica column which was then eluted with methanol. The eluent was evaporated to dry

ness under a stream of roo m temperature air and the residue was redissolved in hexane. Aliquots were analyzed for flutriafol using a gas chromatograph fitted with a nitrogen selective thermionic detector and the an internal standardization technique. Samples were not anal yz ed for transformation products of flutriafol. For the “freshl y applied” samples , the measured Kd values ranged from 1.4 to 73 . C orresponding Koc values ranged from 110 to 590. For the “aged residues” samples , Kd values ranged from 2.4 to 130 . C orresponding Koc values ranged from 190 to 1300. This study is classified as supplemental. All soil s used were foreign soils collected either from seven fields treat ed once three ye ars previous to sampling, or from nine fields tre ated annually for nine ye ars previous to124

soil sample collection
. After all applications, the flutriafol was incorporated into the first 20 centimeters soil, and allowed to age in the open environment. These “aged residues” were desorbed from the soils through reflux. Material balances were not determined. As a result, mobility values derived from this study should not be used a s model input parameters. MRID 47 345401 The behaviour of [triazole
14 C]
- labeled (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol ( [ 14 C] flutri afol) was studied in four European soils: a silty clay soil and a silty

clay loam soil , each from France; and a loam soil and a loamy sand soil , each from Germany. This study was designed to evaluate the effect of time on the adsorption properties of flu triafol in soil. As such, the study was not designed as a ty

pical batch equilibrium or column leaching study . The non - guideline study was comprised of what the study authors describe as a “ time dependent sorption experiment ” and a “ concentration dependent sorption experiment ”. For the time dependent sorption experiment , the test soils were dried and sieved prior to use. [ 14 C] f lutriafol was applied moistened soils at a rate of 0.117 mg a.i./kg in cylindrical metabolism flasks connected to individual flo w - through volatile trapping s ys tems. S oils were aged for up to 308 day s under aerobic conditions in darkness at 20  2  C ; d uplicate samples were collected at 0, 30, 70, 120, 203, and 308 day s posttreatment. T he aged soil s were transferred to centrifuge tubes, 0.01M CaCl 2 solution was added to yield soil solution ratios of 1:1 (w:v), and the tubes were shaken at 2 0  2  C for 48 hours
. For the concentration dependent sorption experiment , flasks were prepared as described for the time dependent sorption fl asks, except that the test soils were treated with [ 14 C]flutriafol at 0.012, 0.038, 0.117, 0.39, and 1.16 mg a.i./kg, and the samples were collected only at day 0
. Traps were not employed. One extraction step was performed for each test soil. All sample s were centrifuged and aliquots of the supernatant solutions analy zed for total radioactivity

using LSC ; aliquots of the supernatant solution s were partitioned with ethyl acetate and anal yz ed for flutriafol using HPL C and TL C. The soil was further extract ed with acetonitrile:water (4:1, v:v), up to three times by shaking and once b y Soxhlet extraction ; aliquots of the combined extracts were anal yz ed using L SC and HPL C. The presence of f lutriafol was identified by comparison to an unlabeled reference stand ard ; the identity of flutriafol was confirmed using TLC. Samples were also for transformation products of flutriafol. In the time dependent sorption experiment , distribution coefficients (derived from the amount of flutriafol in the soil extracts to the concentration of flutriafol in the 0.01M CaCl 2 solution) increased with time of aging; higher percentages in the extracts tracked with higher time
- 0 Kds. In the concentration dependent sorption experiment , s orption of flutriafol increased with decreasing t est concentration applied to the soil s. This non - guideline study is classified as providing ancillary information on the mobility of flutriafol in soils. An adsorption phase was not conducted for the time dependent sorption or concentration dependent sor ption experiments , so it was not performed according to guidelines for adsorption/desorption studies. As a result, mo bility values derived from this study should not be used as model input parameters.125

Bioconcentration in Fish MRID 47090437 The bioaccumulation of [ 14 C
- triazole]labeled, [ 14 C
- carbinol]labeled, and unlabeled (RS)
- 2,4 ′
- Difluoro
- α - (1H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; specific activity

2.6 MBq/mmol), prepared as a mixture dissolved in methanol, was studied in bluegill sunfish (

Lepomis macrochirus ) at a nominal concentration of 50 mg/L under flow
through conditions. The study was conducted in 1982 prior to the adoption of current registration guidelines, but was submitted under USEPA OPP Guideline 165
- 4. The test sy s tem consisted of two 80
- L glass test aquaria. One was treated with [ 14 C]flutriafol and one served as a control. The test aquaria were filled with aerated, dechlorinated “mains” dilution water at a flow rate of 250 mL/minute using calibrated flow
- meters. [ 14 C]Flutriafol, dissolved in methanol, was delivered into the dilution water of the exposure aquarium. A 0.4% methanol solution was delivered into the dilution water of the control aquarium. The solutions were injected continuously into each aquarium, using a Series II Micrometering Pump, at flow rate of 1 mL/minute. The aquaria were equilibrated for 24 hours prior to addition of the fish. The fish were exposed for 21 day s at ca. 18  C . Following exposure, a 7
- day depuration phase was initiated by

transferring 60 of the remaining fish from the control and exposure test vessels to fresh test vessels that were continuously replenished with dilution water. Seven fish were collected after 1, 3, 7, 14, and 21 day s of exposure and after 1, 3, and 7 days of depuration. Three fish were frozen whole and analy zed by L SC following combustion. The remaining fish were separated into muscle and viscera tissue and anal yz ed by L SC following combustion. Water samples were collected from the exposed and control vesse ls dail y during the exposure period. Aliquots were analyzed directly by L SC. Additional water samples were collected from the treated test vessels after 0, 3, 10, 17, and 21 day s of exposure, and were anal yz ed b y LSC and TL C following solvent extraction. Water quality

parameters were reportedl y monitored and maintained throughout the study period. Aeration was used to maintain the ox ygen content in the water. The fish removed for analysis had a mean body weight of 0.87  0.23 g and a mean body length o f 37.0  2.6 mm. Based on TL C anal ys is of additional water samples collected on days 0, 3, 10, 17, and 21 of exposure, [ 14 C]flutriafol was relativel y stable, accounting for 86
- 93% of the recovered radioactivity . Flutriafol was the onl y compound detected. In whole fish, muscle, and viscera tissues, [ 14 C]flutriafol residues rapidly accumulated and reached a plateau within 3
- 21 day s of exposure. Maximum BCF values were 6.8 for whole fish (day 3), 4.7 for muscle tissue (day 3), and 12.2 for viscera tissue ( day 21). During the 7
- day

depuration period, [ 14 C]flutriafol residues in the whole fish decreased to a mean of 20% b y 1 day , and to 2% by 7 days. In the muscle tissue, [ 14 C]flutriafol residues decreased b y a mean of 3% at 1 day of depuration. In the vis cera tissue, [ 14 C]flutriafol residues decreased to a mean of 31% by 1 day of depuration, and to 1
- 3% b y 3
- 7 day s depuration. This126

study is classified as acceptable. Terrestrial Field Dissipation MRID 47090429 The dissipation of [triazole
- 3,5
- U
14 C]
- l abeled (RS)
- 2,4 ′
- difluoro
- α - (1H
1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity 99.9% ) was studied in sandy loam, clay

loam and sandy

clay loam soils in the United Kingdom for 24 weeks under field conditions. [ 14 C]Flutriafol was applied at a nominal rate of 250 g a.i./ha. This study does not appear to have been designed to fulfill Subdivision N guideline requirements. The test sy stem consisted of a single treated field plot per site; the sandy loam soil was bare ground, whil e the clay

loam and sandy

clay loam soils were sown to barel y just prior to treatment. The test solution was applied using a hand
- pumped sprayer. Following treatment, duplicate soil cores were collected after 0, 6, 12 and 24 weeks from the sandy loam plo t, and after 0, 5, 8 and 24 weeks from the clay

loam and sandy

clay loam plots. Plants, when present, were pulled from the soil cores upon sampling and retained for analysis. Soil cores were segmented and reflux extracted twice with acetonitrile:water. Soil extracts, extracted soil and plant material were anal yz ed for total radioactivity using LSC. The initial extract was conc entrated via rotary evaporation , then anal yz ed for flutriafol and its transformation products via one
- dimensional, normal
- phase TLC against reference standard. Only one reference standard , flutriafol , was used for identification purposes. A second confirmatory method was not utilized. Recoveries between replicate cores were highl y variable, which the study authors attributed to the small number of samples taken at each interval and/or variability due to the hand
- spraying application method. For all three soils, the majority of the [ 14 C]residues were recovered in the 0
- to 10
- cm soil depth at all intervals Dissipation of parent flutriafol appeared fastest in the sandy loam and slowest in the clay loam, but significant variability of the results between replicate cores and between sampling intervals preclude any accurate interpretation of the results. Additionally, as the sandy l oam soil was bare ground, but both the clay loam and sandy clay loam soils were cropped, what effect, if any, cropping may

have had could not be assessed. No major transformation products were detected and no minor products were identified. Flutriafol slowly

dissipated under field conditions . Residues remained primarily in the 0
- to 10
- cm soil horizon, with formation of bound soil residues and minor formation of at least one nonvolatile product. At the sandy loam soil site, an additional test s ys tem c onsisted of plastic cylinders embedded into bare ground, and the soil within each cylinder was treated with [ 14 C]flutriafol at 290 g a.i./ha. The test solution was applied dropwise via pipette to the soil surface. Following treatment, soil within half of the cylinders was planted with barley . During the initial 7 weeks posttreatment, half of the bare ground and half of the cropped cylinders were alternatel y covered with a glass dome connected to a flow
- through s ys tem with traps for the collection of CO 2 and volatile organics. V olatiles were collected for 24
- hour intervals. An entire cylinder was sampled at 0, 3, 12, 18 and 33 weeks posttreatment for the bare ground soil and at 3, 12 and 33 weeks for127

cropped soil. Plants , when present, were pulled from the soil upon sampling and retained for anal ys is. Soil and plant material were analyzed as described above. Trapping solutions were anal yz ed for total radioactivity by L SC. There were no significant differences in the patterns of dissipation or recoveri es of residues between the bare ground and cropped soil. The study authors noted that growth of the barley was poor and none survived after 12 weeks; weeds were allowed to grow and collected as plant material. The majority of the [ 14 C]residues were recovered in the 0
- to 10
- cm soil depth at all intervals. This study

is classified as supplemental. No attempt was made to identify potentiall y toxic degradation products of flutriafol. It was not established that the foreign test soils, where this study was conducted, are comparable to soils that would be found at intended use sites for flutriafol in the United States. For the portion of this study conducted at the clay loam and sandy clay loam soil sites , results were too variable to accuratel y assess dissipation of flutriafol and its residues. Results Synopsis: Test system used: Sandy loam soil in the United Kingdom; bare ground plot. Linear half

- life: 15.1 weeks (r2 = 0.5195). Non
- linear half

- life: 17.0 weeks (r2 = 0.5246). Observe d DT 50 : ca . 18 weeks. Major transformation products: None detected
. Minor transformation products: None identified
. Test system used: Clay loam soil in the United Kingdom; cropped plot. Linear half

- life: 142 weeks (r2 = 0.0061). Non
- linear half

- life: 49. 5 weeks (r2 = 0.0494). Observed DT 50 : ND (not determined). Major transformation products: None detected
. Minor transformation products: None identified
. Test system used: Sandy clay loam soil in the United Kingdom; cropped plot. Linear half

- life: 42.2 weeks (r2 = 0.0516). Non
- linear half

- life: 32.4 weeks (r2 = 0.0775). Observed DT 50 : ND. Major transformation products: None detected
. Minor transformation products: None identified
. Test system used: Sandy loam soil in the United Kingdom; bare ground + crop ped, in ground cylinders. Linear half

- life: 37.3 weeks (r2 = 0.8794). Non
- linear half

- life: 33.8 weeks (r2 = 0.8784). Observed DT 50 : ca . 30 weeks. Major transformation products: None detected
. Minor transformation products: None identified
.128

MRID 4709043 1 Soil dissipation/accumulation of flutriafol ( (RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol ) under Euro pean field conditions was studied using bare plots at six sites in Germany . The plots were sown with spring barley or oats following spring application of the test substance, or with winter wheat following fall application of the test substance to mimic normal agricultural practices. Soil textures were not reported for any of the test sites. The experiment was not carried out in accordance with any reported guidelines or stand ards. However, a portion of the laboratory phase of the study was conducted in compliance with the Principles of Good L aboratory Practice laid down in the United Kingdom Department of Health Compliance programme (1989)
. Flutriafol was sprayed once at eac h test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at each site. Following application, the plots were raked to a depth of 2
- 3 cm to incorporate the test chemical. The maximum label rate was not reported. Total precipitation during the study period at each of the six test sites was not reported. A control plot was not specified. The application rate was not verified at any of the six test sites using application monitoring devices. Field spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. Soil samples were collected from Site 1 from 102 to 1993 day s, from Site 2 from 0 to 1779 day s, from Site 3 from 0 to 2195 day s, from Site 4 from 0 to 1814 day s, from Site 5 from 109 to 1299 day s, and from Site 6 from 102 to 2010 day s following the test application to a depth of 0
- 30 cm. Soil cores were generall y sectioned into 0
- 5, 5
- 10, 10
- 20, and 20
- 30 cm segments. Soil samples were reflux extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned
- up using adsorption chromatography, and anal yz ed for flutriafol by gas - liquid chromatography with nitrogen selective detection. Samples were not analyzed for transformation products of flutri afol. This study

is classified supplemental. In spite of the deficiencies in this study , sampling was conducted for a sufficient length of time to demonstrate the persistence of flutriafol on the order of years in terrestrial environments, and that dete ctions of flutriafol at the bottom of the sampled column shows an ability

to slowly leach through the soil profile. A storage stability study was not conducted. No attempt was made to identify potentially

toxic minor degradation products of flutriafol. Sampling was not conducted to a sufficient depth to define leaching. S oil was not characterized, and the registrant did not demonstrate comparability between the test site soil and U.S. soil. RESULTS SYNOPSIS Site 1 Location/soil ty

pe: Lichtenhagen, Germany/ Not reported. Half
- life: 1155 day s (r2 = 0.8479; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissip ation routes: Could not be determined.129

Site 2 Location/soil ty

pe: Lichtenhagen, Germany/ Not reported. Half
- life: 866 day s (r2 = 0.8353; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transfor

mation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 3 Location/soil ty

pe: Mottingen, Germany/ Not reported. Half
- life: 770 day s (r2 = 0.8308; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 4 Location/soil ty

pe: Damsdo rf, Germany/ Not reported. Half
- life: 866 day s (r2 = 0.7031; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 5 Location/soil ty

pe: Bohringen, Germany/ Not reported. Half
- life: 1155 day s (r2 = 0.5453; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products det ected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 6 Location/soil ty

pe: Wankendorf, Germany/ Not reported. Half
- life: 1386 day s (r2 = 0.7094; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined.

MRID 47090432 Soil dissipation/accumulation of flutriafol ((RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol) under European field conditions was studied using bare plots at three sites in France. Following application, the plots were generally cultivated and cropped in each ye ar of the study foll owing normal agricultural practices. Flutriafol was sprayed once at each test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at each site; plots were not replicated. Following application, the plots were raked to a depth of 2
- 3 cm to incorporate the test chemical. Total precipitation during the study period at each of the three test sites was not reported. A control plot was located an unspecified distance from the treated plot at each test130

site. The application rate was not verified at any of the three test sites using application monitoring devices. Field spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. Samples were collected from Site 1 at 0, 113, 174, 264, 357, 448, 547, 625, 714, 832, 933, 1079, 1282, and 1459 day s, from Site 2 at 0, 96, 189, 272, 378, 541, 776, 904, 1148, 1308, and 1526 day s and from Site 3 at 87, 180, 277, 362, 551, and 723 day s following the test application to a depth of 0
- 30 cm , and were sectioned into 0
- 5, 5
- 10, 10
- 20, and 20
- 30 cm segments. Soil samples were reflux extract ed with acetonitrile:pH 9 water , partitioned into dichloromethane, cleaned
- up using adsorption chromatography, and anal yz ed for flutriafol by gas - liquid chromatography with nitrogen selective detection. Samples were not anal yz ed for transformation products of flutriafol. The storage interval of the test samples prior to anal ys is was not reported. The major route of dissipation of flutriafol under terrestrial field conditions could not be determined because soil was not anal yz ed for transformation products of flutriafol, leaching was not adequatel y determined , and volatilization, plant uptake, and runoff were not studied. This study is classified supplemental. Inspite of the deficiencies in this study , sampling was conducted for a sufficient length of time to demonstrate the persistence of flutriafol on the order of years in terrestrial environments, and that detections of flutriafol at the botto m of the sampled column shows an ability

to slowly leach through the soil profile. A storage stability study was not conducted. No attempt was made to identify potentially

toxic minor degradation products of flutriafol. Sampling was not conducted to a sufficient depth to define leaching. A site use history was not provided for any of the three test sites. The limit of quantitation of the anal ytical method was not reported. S oil samples were excessively composited. S oil was not characterized, and the registrant did not demonstrate comparability between the test site soil and U.S. soil. RESULTS SYNOPSIS Site 1 (Toulouse 71/82) Location/soil ty

pe: Toulouse, France/Sandy clay loam. Half
- life: 990 day s (r2 = 0.6449; based on all d ata from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 2 (Tours 84/82) Location/soil ty

pe: Tours, France/Clay
. Half
- life: 408 day s (r2 = 0.7780; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation rout es: Could not be determined.131

Site 3 (Tours 73/82) Location/soil ty

pe: Tours, France/Silty clay
. Half
- life: 1733 day s (r2 = 0.1586; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformati on products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. MRID 47090433 Soil dissipation/accumulation of flutriafol ((RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol) under Eur opean field conditions was studied using cropped plots at six sites in Germany. Soil textures were not reported for any of the test sites. Flutriafol was applied as a foliar spray at each test site to test plots approximately 0.5
- 1.2 ha using multiple application. Flutriafol was applied annually , between late April and late June, at a target rate of 0.188 kg a.i./ha for the first application and 0.25 kg a.i./ha for subsequent applications. The maximum label rate was not reported. Total precipitation during the study period at each of the six test sites was not reported. Control samples were analyzed alongside test samples. The application rate was not verified at any of the six test sites using application monitoring devices. Fi eld spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. Soil samples were collected from each test site at harvest and in the spring of the following ye ar, following each test application; day 0 samples were not collected. Soil cores were collected to a nominal depth of 0
- 30 cm and were not sectioned. Soil samples were reflux extract ed with acetonitrile:pH 9 water , partitioned into dichloromethane, cleaned
- up using adsorption chromat ography, and analy zed for flutriafol by

gas - liquid chromatography with nitrogen selective detection. The LOD was 0.005
- 0.01 mg/kg. Samples were not analyzed for transformation products of flutriafol. The storage interval of the test samples prior to analy sis was not reported. Half
- lives and DT 90 values could not be calculated for flutriafol for any of the six test sites because flutriafol residues generall y increased annually with each test application and an insufficient number of samples was collecte d following the final application to track the dissipation of flutriafol. Following the last application, soil was only sampled for flutriafol at harvest and in the spring of the following ye ar or only at harvest. Carryover of residues was 27% of the tot al applied flutriafol at Site 1 at the end of the 1563
- day study period
. The major route of dissipation of flutriafol under terrestrial field conditions at the six test sites could not be determined because an insufficient number of samples were collected following the final application to track the dissipation of flutriafol. This study is classified supplemental. The pattern of formation and decline of the transformation products of flutriafol could not be determined. Sampling was not conducted to a sufficient depth to define leaching. A complete site use history

was not provided for any of the six test sites. S oil samples were excessively composited. The registrant did not demonstrate comparability between the test site soil and U.S. soil.132

RESULT S SYNOPSIS Site 1 Location/soil ty

pe: Wankendorf, Germany/ Not reported. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 2 Location/soil ty

pe: Petersdorf, Germany/ Not reported. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyze d for transformation products. Dissipation routes: Could not be determined. Site 3 Location/soil ty

pe: Lichtenhagen, Germany/ Not reported. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 4 Location/soil ty

pe: Neubruchausen, Germany/Not reported. Half
- life: Could not be determined. DT 90 : Could not b e determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 5 Location/soil ty

pe: Mottingen, Germany/ Not reported. Half
- life: Could not b e determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 6 Location/soil ty

pe: Bohringen, Germany/ Not reported. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. MRID 47090434 Soil dissipation/accumul ation of flutriafol (( RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
-133

triazol
- 1
- ylmethyl)benzhydryl alcohol) under European field conditions was studied using cropped plots at four sites in France. The classification sy stem used for the textural classification was not reported. The experiment was not carried out in accordance with any reported guidelines or standards
. Flutriafol was applied as a foliar spray at each test site to test plots ranging from 0.1 to 1.0 ha using multiple applications
. Flutriafol was applied annu all y. The maximum label rate was not reported. Total precipitation during the study period at each of the four test sites was not reported. Control plots were not specified. The application rate was not verified at any of the four test sites using application monitoring devices. Field spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. Soil samples were collected from each test site at harvest and in the spring of the following ye ar, following each test application . D ay 0 samples were not collected. Soil samples were reflux extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned
- up using adsorption chromatography , and anal yz ed for flutriafol by gas - liquid chromatography with nitrogen selective detection. The LOD was 0.005
- 0.01 mg/kg. Samples were not anal yz ed for transformation products of flutriafol. The storage interval of the test samples prior to anal ys is was not reported. Half
- lives and DT 90 values could not be calculated for flutriafol for any of the four test sites because flutriafol residues generall y increased annually with each test application, and an insufficient number of samples was collected following the final appl ication to track the dissipation of flutriafol. Following the last application at each test site in 1989, soil was only sampled for flutriafol at harvest. The major route of dissipation of flutriafol under terrestrial field conditions at the four test sites could not be determined because an insufficient number of samples was collected following the final application to track the dissipation of flutriafol. Additionally, soil was not analyzed for transformation products of flutriafol, leaching was not d etermined, and volatilization, plant uptake, and runoff were not studied. This study is classified supplemental. No significant deviations from good scientific practices were noted. Half
- lives of flutriafol could not be calculated. A storage stability study was not conducted. The pattern of formation and decline of the transformation products of flutriafol could not be determined. A complete site use history was not provided for any of the four test sites. The limit of quantitation of the anal ytical me thod was not reported. Soil samples were excessively composited. Soil was not adequatel y characterized. The registrant did not demonstrate comparability between the test site soil and U.S. soil. RESULTS SYNOPSIS Site 1 Location/s oil ty

pe: VilleFranche, France/Sandy
. Half
- life: Could not be determined. DT 90 : Could not be determined.134

Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 2 Location/soil ty

pe: Tours, France/Chalk. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be det ermined. Site 3 Location/soil ty

pe: Toulouse, France/Sandy clay loam. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Di ssipation routes: Could not be determined. Site 4 Location/soil ty

pe: Reims, France/Chalk. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transf ormation products. Dissipation routes: Could not be determined. MRID 47090435 Soil dissipation/accumulation of flutriafol (( RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol) under Europ ean field conditions was studied using cropped plots at six sites in the United Kingdom. Flutriafol was applied as a foliar spray at each test site to test plots of approximatel y 1 ha using multiple applications. Flutriafol was applied annually , between late March and early July , at a target rate of 0.188 kg a.i./ha for the first application and 0.25 kg a.i./ha for subsequent applications. The maximum label rate was not reporte d. Total precipitation during the study period at each of the six test sites was not reported. Control plots were not specified. The application rate was not verified at any of the six test sites using application monitoring devic es. Field spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. Soil samples were generally collected from each test site at harvest and in the spring of the following ye ar, following each test application, but were generally not collected in the spring following the last application. Day 0 samples were not collected. Soil cores were collected to a nominal depth of 0
- 30 cm and were not sectioned. Soil samples were reflux extracted with acetonitrile:pH 9 water (ratio not reported), partitioned into dichloromethane, cleaned
- up using adsorption chromatography , and anal yz ed for flutriafol by gas - liquid chromatography with nitrogen selective detection. The LOD was 0.005
- 0.01 mg/kg. Sample s were not anal yz ed for transformation products of flutriafol. The storage interval of the test samples prior to anal ys is135

was not reported. The reported calculated mass accounting was based on the measurement of flutriafol in the 0
- 30 cm soil depth and the cumulative applied rate of flutriafol. Half
- lives and DT 90 values could not be calculated for flutriafol for any of the six test sites because flutriafol residues generall y increased annually with each test application, and an insufficient number of samples was collected following the final application to track the dissipation of flutriafol. Following the last application, soil was only sampled for flutriafol at harvest or at harvest and in the spring of the following ye ar. The major route of dis sipation of flutriafol under terrestrial field conditions at the six test sites could not be determined because an insufficient number of samples were collected following the final application to track the dissipation of flutriafol. Additionally, soil was not analyzed for transformation products of flutriafol, leaching was not determined, and volatilization, plant uptake, and runoff were not studied. This study is classified supplemental. Half
- lives of flutriafol could not be calculated. A storage stab ility study was not conducted. The pattern of formation and decline of the transformation products of flutriafol could not be determined. Sampling was not conducted to a sufficient depth to define leaching. A site use history was not provided for any of the six test sites. The limit of quantitation of the anal yt ical method was not reported. S oil samples were excessivel y composited. The registrant did not demonstrate comparability

between the test site soil and U.S. soil. RESULTS SYNOPSIS Site 1 Location/soil ty

pe: Boxford, United Kingdom/Clay loam. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 2 Location/soil ty

pe: Benson, United Kingdom/Clay loam. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation prod ucts. Dissipation routes: Could not be determined. Site 3 Location/soil ty

pe: Chalgrove, United Kingdom/Sandy clay loam. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 4136

Location/soil ty

pe: West Horsley , United Kingdom/Loamy sand. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 5 Location/soil ty

pe: Stanton St John, United Kingdom/Clay loam. Half
- life: Could not be determin ed. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 6 Location/soil ty

pe: White Waltham, United Kingdom/Sandy loam. Half
- life: Could not be determined. DT 90 : Could not be determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. MRID 47115502 Soil dissipation/accumulation o f flutriafol (( RS )
- 2,4 ′
- difluoro
- α - (1 H
- 1,2,4
- triazol
- 1
- ylmethyl)benzhydryl alcohol) under Euro pean field conditions was studied using bare plots at three sites in the United Kingdom. Following application, the plots were generally cultivated and cropped in each ye ar of th e study following normal agricultural practices. This experiment was not carried out in accordance with any reported guidelines or standards. Flutriafol was sprayed once at each test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at each site . Plots were not replicated. Following application, the plots were raked to a depth of 2
- 3 cm to incorporate the test chemical. The maximum label rate was not reported. Total precipitation during the study period at each of the three test sites was not r eported. A control plot was established at each test site, control plots were located an unspecified distance from the treated plot. The application rate was not verified at any of the three test sites using application monitoring devices. Field spikes were not prepared to determine the stability of the parent and transformation products during transport and storage. However, the final four cores were collected at Site 1, the final three cores collected at Site 2 and the final two cores collected at Site 3 were not sectioned, and were anal yz ed as a bulk 0
- 30 cm sample. Soil samples were reflux extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned
- up using adsorption chromatography, and anal yzed for flutriafol b y gas - liquid chromatography with nitrogen selective detection. The LOD was 0.01 mg/kg. Samples were not anal yz ed for transformation products of flutriafol. The storage interval of the test samples prior to analy sis was not reported. As is comm on with terrestrial field dissipation studies, there was a more rapid decline through137

the top 5 cm of the soil profile during the initial year of the study . The DT 90 was not determined. The major route of dissipation of flutriafol under terrestrial field conditions at the three test sites could not be determined because soil was not analyzed for transformation products of flutriafol, leaching was not adequately determined and volatilization, plant uptake, and runoff were not studied. This study

is classi fied as supplemental. In spite of the deficiencies in this study, sampling was conducted for a sufficient length of time to demonstrate the persistence of flutriafol in terrestrial environments. A storage stability study was not conducted. The pattern o f formation and decline of the transformation products of flutriafol could not be determined. Sampling was not conducted to a sufficient depth to differentiate between degradation and leaching. A site use history was not provided for any of the three tes t sites. The limit of quantitation of the anal yt ical method was not reported. S oil samples were excessively composited. Finally , the registrant did not demonstrate comparability between the test site soil and U.S. soil. RESULTS SYNOPSIS Site 1 Location/soil ty

pe: West Horsley , United Kingdom/Loamy sand. Half
- life: 1155 day s (r2 = 0.9158; based on all data from the total 0
- to 30
- cm soil profile). DT 90 : Not determined. Major transformation products detected: Samples not analyzed f or transformation products. Dissipation routes: Could not be determined. Site 2 Location/soil ty

pe: Boxford, United Kingdom/Clay loam. Half
- life: 3466 day s (r2 = 0.4350; based on all data from the total 0
- to 30
- cm soil profile). DT 9 0 : Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined. Site 3 Location/soil ty

pe: Chalgrove, United Kingdom/Sandy clay loam. Half
- life : 2310 day s (r2 = 0.4531; based on all data from the total 0
- to 30
- cm soil profile). DT 9 0: Not determined. Major transformation products detected: Samples not analyzed for transformation products. Dissipation routes: Could not be determined.138

Table 2: Su mmary of Carry- Over Values from Terrestrial Field Dissipation Studies Percent Flutriafol Residue Carryover Study Termination at 0 Day Post- Treatment Approximate Number of Years Post - Treatment 15% 1993 day approximately 51⁄2 years 13% 1779 day approximately 5 years 9% 2195 day approximately 6 years 17% 1814 day approximately 5 years 17% 1299 day approximately 31⁄2 years 23% 2010 day approximately 51⁄2 years 18% 459 day approximately 4 years 4 % 1526 day approximately 4 years 37 % 723 day approximately 2 years 27% 1563 day 19% 1457 day 23% 1399 day 48% 1375 day 17% 1539 day 9% 1172 day 11% 2634 day 19% 2639 day 11% 2675 day 16% 2638 day 45% 2998 day 36% 3013 day 41% 2895 day 35% 2989 day 49% 2998 day 26% 485 day 9% 3050 day >8 ye ars 34% 3044 day >8 years 14% 2670 day >7 years Non - Guideline MRID 47090436 The biotransformation of flutriafol [ (RS)
- 2,4 ′
- difluoro
- α - (1H
- 1,2,4
- triazol
1
- ylmethyl)benzhydryl alcohol] was re
- assessed using existing experimental datasets for laborat ory

soil degradation, field dissipation and water/sediment s ys tem studies to obtain first order DT 50 and DT 90 values by non - linear regression analy sis. Since this study report contains no original data, GLP Standards do not appl y. In accordance with the proposed FOCUS kinetics group recommendations , DT 50 and DT 90 values were calculated from existing raw data using first order non
- linear regression anal ys is as determined by the Solver program within Microsoft Excel (2002). Goodness of fit was assessed two way s, by a formal statistical approach using coefficient of determination (r2 ) and through personal judgment , ‘b y eye’
.139



### Appendix B. Aquatic Exposure Modeling and Results 1. GENEEC2 EECs Apples, Ground application RUN No. 1 FOR flutriafol ON apples * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO
- SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

- ------------------------------------------------------------------- .110( .659) 4 7 140.0 130.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

------------------------------------------------------------- ------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND
- EFF) (POND) (POND)

-------------------------------------------------------------------- 8665.00 2 N/A .00
- .00 .00 .00 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 21.24 21.22 21.11 20.87 20.70 Soybeans, Ground application (21 - day intervals) RUN No. 2 FOR flutriafol ON soybean * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO
- SPRAY INCORP ONE(MULT) INTERVAL Koc (PP M ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .060( .180) 3 21 140.0 130.0 AERL_B( 13.0) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

------------------------- ------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND
- EFF) (POND) (POND)

----------------------------------------------------------------- --- 8665.00 2 N/A .00
- .00 .00 .00 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 9.00 8.99 8.95 8.85 8.78140

Soybeans , Ground application (14 - day intervals) RUN No. 3 FOR flutriafol ON soy * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO
- SPRAY INCOR P ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .060( .180) 3 14 140.0 130.0 GRHIFI( 6.6) .0 .0
FIELD AND STANDARD POND HALFLIFE VA LUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND
- EFF) (POND) (POND)

------------------------ -------------------------------------------- 8665.00 2 N/A .00
- .00 .00 .00 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

--------------------------------------------------------------- ----- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 8.69 8.68 8.64 8.54 8.47 Soybeans, Aerial application (21 - day intervals) RUN No. 4 FOR flutriafol ON soybean * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO - SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .060( .180) 3 21 140.0 130.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND
- EFF) (POND) (POND)

-------------------------------------------------------------------- 8665.00 2 N/A .00
- .00 .00 .00 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

---------------------------- ---------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 8.68 8.68 8.63 8.53 8.46141

Soybeans, Aerial application (14 - day intervals) RUN No. 5 FOR flutriafol ON soy bean * INPUT VALUES *

--------------------------------------------------------- ----------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO
- SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .060( .180) 3 14 140.0 130.0 AERL_A( 24.1) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAI N/RUNOFF (POND) (POND
- EFF) (POND) (POND)

-------------------------------------------------------------------- 8665.00 2 N/A .00
- .00 .00 .00 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------- ------------------------------------------ 10.13 10.13 10.08 9.97 9.90 

### 2. PRZM/EXAMs EECs NC APPLE stored as NCapp.out Chemical: Flutriafol PRZM environment: NCappleSTD.txt modified Tueday, 29 May 2007 at 12:58: 16 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 05:14:08 Metfile: w03812.dvf modified Tueday, 26 August 2008 at 05:14:10 Water segment concentrations (ppb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1965 3.2 3.136 2.901 2.595 2.358 1 .12 1966 4.898 4.822 4.655 4.224 3.89 2.354 1967 4.896 4.843 4.667 4.175 3.89 2.716 1968 4.125 4.062 3.857 3.483 3.264 2.422 1969 2.981 2.959 2.83 2.619 2.457 1.857 1970 2.173 2.145 2.064 1.9 1.821 1.396 1971 2.743 2.705 2.59 2.444 2.28 1.469 1972 3.684 3. 631 3.418 3.272 3.132 1.988 1973 11.18 11.05 10.25 8.795 7.938 4.32 1974 5.298 5.236 5.026 4.77 4.541 3.57 1975 6.416 6.314 5.922 5.419 5.04 3.32 1976 9.327 9.186 8.619 7.54 6.886 4.315 1977 4.218 4.174 4.068 3.914 3.74 3.129 1978 3.621 3.566 3.4 3.179 3 2 .215 1979 3.028 2.984 2.896 2.645 2.495 1.813 1980 5.808 5.71 5.439 4.784 4.332 2.481 1981 6.999 6.896 6.597 5.708 5.174 3.213142

1982 4.131 4.074 3.897 3.547 3.327 2.606 1983 3.27 3.223 3.101 2.899 2.689 1.951 1984 4.377 4.313 4.033 3.742 3.484 2.26 1985 2.6 14 2.584 2.46 2.303 2.214 1.791 1986 2.914 2.872 2.717 2.386 2.197 1.524 1987 12.39 12.14 11.27 9.722 8.739 4.391 1988 4.65 4.608 4.51 4.428 4.344 3.609 1989 4.848 4.798 4.554 4.194 3.955 2.809 1990 4.338 4.279 4.024 3.663 3.515 2.509 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.037037037037037 12.39 12.14 11.27 9.722 8.739 4.391 0.0740740740740741 11.18 11.05 10.25 8.795 7.938 4.32 0.111111111111111 9.327 9.186 8.619 7.54 6.886 4.315 0.148148148148148 6.999 6.896 6.597 5.708 5.174 3.609 0 .185185185185185 6.416 6.314 5.922 5.419 5.04 3.57 0.222222222222222 5.808 5.71 5.439 4.784 4.541 3.32 0.259259259259259 5.298 5.236 5.026 4.77 4.344 3.213 0.296296296296296 4.898 4.843 4.667 4.428 4.332 3.129 0.333333333333333 4.896 4.822 4.655 4.224 3.95 5 2.809 0.37037037037037 4.848 4.798 4.554 4.194 3.89 2.716 0.407407407407407 4.65 4.608 4.51 4.175 3.89 2.606 0.444444444444444 4.377 4.313 4.068 3.914 3.74 2.509 0.481481481481481 4.338 4.279 4.033 3.742 3.515 2.481 0.518518518518518 4.218 4.174 4.024 3. 663 3.484 2.422 0.555555555555556 4.131 4.074 3.897 3.547 3.327 2.354 0.592592592592593 4.125 4.062 3.857 3.483 3.264 2.26 0.62962962962963 3.684 3.631 3.418 3.272 3.132 2.215 0.666666666666667 3.621 3.566 3.4 3.179 3 1.988 0.703703703703704 3.27 3.223 3.1 01 2.899 2.689 1.951 0.740740740740741 3.2 3.136 2.901 2.645 2.495 1.857 0.777777777777778 3.028 2.984 2.896 2.619 2.457 1.813 0.814814814814815 2.981 2.959 2.83 2.595 2.358 1.791 0.851851851851852 2.914 2.872 2.717 2.444 2.28 1.524 0.888888888888889 2.743 2.705 2.59 2.386 2.214 1.469 0.925925925925926 2.614 2.584 2.46 2.303 2.197 1.396 0.962962962962963 2.173 2.145 2.064 1.9 1.821 1.12 0.1 9.8829 9.7452 9.1083 7.9165 7.2016 4.3165 Average of yearly averages: 2.58261538461539 Inputs generated by pe5. pl
- Novemeber 2006 Data used for this run: Output File: NCapp Metfile: w03812.dvf PRZM scenario: NCappleSTD.txt EXAMS environment file: pond298.exv Chemical Name: Flutriafol Description Variable Name Value Units Comments Molecular weight mwt 301.3 g/mol Henry's Law Const. henry 1.3E
- 11 atm - m^3/mol Vapor Pressure vapr 3E
- 9 torr Solubility sol 130 mg/L Kd Kd mg/L Koc Koc 322 mg/L Photolysis half

- life kdp days Half
- life Aerobic Aquatic Metabolism kbacw 100 days Halfife Anaerobic Aquatic Metabolism kbacs 36 5 days Halfife Aerobic Soil Metabolism asm 3247 days Halfife Hydrolysis: pH 7 days Half
- life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI cm Application Rate: TAPP 0.1232 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift D RFT 0.05 fraction of application rate applied to pond Application Date Date 1
- 5 dd/mm or dd/mmm or dd
- mm or dd
-mmm Interval 1 interval 7 days Set to 0 or delete line for single app. app. rate 1 apprate 0.1232 kg/ha143

Interval 2 interval 7 days Set to 0 or de lete line for single app. app. rate 2 apprate 0.1232 kg/ha Interval 3 interval 7 days Set to 0 or delete line for single app. app. rate 3 apprate 0.1232 kg/ha Record 17: FILTRA

IPSCND 1 UPTKF Record 18: PLVKRT

PLDKRT FEXTRC 0.5 Flag for I ndex Res. Run IR EPA Pond Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)


### OR APPLE stored as ORapp.out Chemical: Flutriafol PRZM environment: ORappleSTD.txt modified Tueday, 29 May 2007 at 13:00:08 EXAMS environment: pond298.exv mo dified Tueday, 26 August 2008 at 05:14:08 Metfile: w24232.dvf modified Tueday, 26 August 2008 at 05:15:54 Water segment concentrations (ppb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 1.129 1.111 1.039 0.9153 0.8408 0.4777 1962 1.769 1.749 1.666 1.5 5 1.506 1.159 1963 2.871 2.837 2.711 2.531 2.393 1.894 1964 2.886 2.86 2.75 2.577 2.449 2.121 1965 2.823 2.798 2.693 2.523 2.396 2.108 1966 2.919 2.891 2.778 2.602 2.474 2.178 1967 2.975 2.948 2.831 2.645 2.508 2.156 1968 2.827 2.796 2.743 2.567 2.436 2.11 9 1969 2.718 2.686 2.559 2.451 2.388 2.113 1970 2.824 2.797 2.683 2.501 2.369 2.016 1971 2.644 2.619 2.518 2.397 2.293 2.042 1972 2.99 2.958 2.831 2.624 2.467 2.003 1973 2.763 2.736 2.625 2.454 2.328 1.981 1974 3.039 3.021 2.923 2.674 2.24 1.882 1975 3.107 3.078 2.962 2.788 2.655 2.298 1976 2.78 2.754 2.651 2.486 2.366 1.921 1977 2.418 2.393 2.292 2.117 1.998 1.566 1978 2.819 2.785 2.657 2.432 2.259 1.655 1979 2.489 2.469 2.408 2.321 2.211 1.858 1980 2.749 2.723 2.626 2.561 2.449 2.068 1981 3.24 3.204 3.082 2.865 2.739 2.334 1982 2.914 2.887 2.77 2.585 2.454 2.061 1983 2.586 2.558 2.449 2.284 2.187 1.804 1984 2.679 2.65 2.531 2.412 2.316 1.775 1985 2.955 2.917 2.786 2.539 2.404 1.895 1986 2.605 2.579 2.469 2.293 2.174 1.78 1987 2.89 2.867 2.816 2.228 2.064 1 .793 1988 3.03 3.003 2.92 2.751 2.619 2.254 1989 2.728 2.701 2.59 2.414 2.291 2.012 1990 2.871 2.847 2.735 2.558 2.423 2.087 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 3.24 3.204 3.082 2.865 2.739 2.334 0.064516129032258 1 3.107 3.078 2.962 2.788 2.655 2.298 0.0967741935483871 3.039 3.021 2.923 2.751 2.619 2.254 0.129032258064516 3.03 3.003 2.92 2.674 2.508 2.178 0.161290322580645 2.99 2.958 2.831 2.645 2.474 2.156 0.193548387096774 2.975 2.948 2.831 2.624 2.467 2.121 0.22 5806451612903 2.955 2.917 2.816 2.602 2.454 2.119 0.258064516129032 2.919 2.891 2.786 2.585 2.449 2.113 0.290322580645161 2.914 2.887 2.778 2.577 2.449 2.108 0.32258064516129 2.89 2.867 2.77 2.567 2.436 2.087144

0.354838709677419 2.886 2.86 2.75 2.561 2.423 2 .068 0.387096774193548 2.871 2.847 2.743 2.558 2.404 2.061 0.419354838709677 2.871 2.837 2.735 2.539 2.396 2.042 0.451612903225806 2.827 2.798 2.711 2.531 2.393 2.016 0.483870967741936 2.824 2.797 2.693 2.523 2.388 2.012 0.516129032258065 2.823 2.796 2.683 2.501 2.369 2.003 0.548387096774194 2.819 2.785 2.657 2.486 2.366 1.981 0.580645161290323 2.78 2.754 2.651 2.454 2.328 1.921 0.612903225806452 2.763 2.736 2.626 2.451 2.316 1.895 0.645161290322581 2.749 2.723 2.625 2.432 2.293 1.894 0.67741935483871 2.728 2.701 2.59 2.414 2.291 1.882 0.709677419354839 2.718 2.686 2.559 2.412 2.259 1.858 0.741935483870968 2.679 2.65 2.531 2.397 2.24 1.804 0.774193548387097 2.644 2.619 2.518 2.321 2.211 1.793 0.806451612903226 2.605 2.579 2.469 2.293 2.187 1.78 0.83870967741 9355 2.586 2.558 2.449 2.284 2.174 1.775 0.870967741935484 2.489 2.469 2.408 2.228 2.064 1.655 0.903225806451613 2.418 2.393 2.292 2.117 1.998 1.566 0.935483870967742 1.769 1.749 1.666 1.55 1.506 1.159 0.967741935483871 1.129 1.111 1.039 0.9153 0.8408 0.47 77 0.1 3.0381 3.0192 2.9227 2.7433 2.6079 2.2464 Average of yearly averages: 1.91369 Inputs generated by pe5.pl
- Novemeber 2006 Data used for this run: Output File: ORapp Metfile: w24232.dvf PRZM scenario: ORappleSTD.txt EXAMS environment file: po nd298.exv Chemical Name: Flutriafol Description Variable Name Value Units Comments Molecular weight mwt 301.3 g/mol Henry's Law Const. henry 1.3E
- 11 atm - m^3/mol Vapor Pressure vapr 3E
- 9 torr Solubility sol 130 mg/L Kd Kd mg/L Koc Koc 322 mg/L Photolysis h alf

- life kdp days Half
- life Aerobic Aquatic Metabolism kbacw 100 days Halfife Anaerobic Aquatic Metabolism kbacs 365 days Halfife Aerobic Soil Metabolism asm 3247 days Halfife Hydrolysis: pH 7 days Half
- life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI cm Application Rate: TAPP 0.1232 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift DRFT 0.05 fraction of application rate applied to pond Application Date Date 1
- 5 dd/mm or dd/mmm or dd
- mm or dd
-mmm Interval 1 interval 7 days Set to 0 or delete line for single app. app. rate 1 apprate 0.1232 kg/ha Interval 2 interval 7 days Set to 0 or delete line for single app. app. rate 2 apprate 0.1232 kg/ha Interval 3 interval 7 days Set to 0 or delete line for single app. app. rate 3 apprate 0.1232 kg/ha Record 17: FILTRA

IPSCND 1 UPTKF Record 18: PLVKRT

PLDKRT FEXTRC 0.5 Flag for I ndex Res. Run IR EPA Pond Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run) 

### PA APPLE145

stored as PAapp.out Chemical: Flutriafol PRZM environment: PAappleSTD_V2.txt modified Tueday, 20 May 2008 at 12:00:22 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 05:14:08 Metfile: w14751.dvf modified Tueday, 26 August 2008 at 05:15:00 Water segment concentrations (p pb) Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 2.565 2.51 2.369 2.087 1.912 0.9281 1962 2.312 2.275 2.134 2.008 1.902 1.427 1963 2.064 2.038 1.991 1.828 1.723 1.305 1964 2.675 2.628 2.454 2.262 2.136 1.502 1965 2.185 2.155 2.073 1.956 1.855 1.405 19 66 5.799 5.69 5.307 4.764 4.484 2.14 1967 4.601 4.529 4.254 3.933 3.882 3.336 1968 6.769 6.719 6.3 5.443 4.912 3.247 1969 5.366 5.264 4.962 4.353 4.028 3.012 1970 3.687 3.652 3.564 3.371 3.269 2.631 1971 3.022 2.986 2.86 2.623 2.486 1.997 1972 8.857 8.689 8.009 6.755 6.078 3.404 1973 6.171 6.097 5.712 4.995 4.608 3.44 1974 3.73 3.684 3.534 3.326 3.151 2.463 1975 3.757 3.7 3.465 3.251 3.096 2.231 1976 3.578 3.516 3.308 3.027 2.822 2.015 1977 2.359 2.328 2.207 2.134 2.048 1.581 1978 3.098 3.047 2.939 2.785 2. 699 1.764 1979 3.291 3.244 3.083 2.824 2.638 1.839 1980 4.116 4.051 3.812 3.334 3.057 1.983 1981 2.454 2.425 2.302 2.235 2.158 1.703 1982 8.007 7.888 7.559 6.662 6.05 3.293 1983 5.382 5.317 5.049 4.461 4.115 3.088 1984 6.364 6.27 5.929 5.425 4.958 3.15 198 5 4.795 4.735 4.639 4.277 3.976 2.891 1986 3.29 3.249 3.09 2.783 2.781 2.306 1987 3.794 3.729 3.473 3.061 2.929 2.167 1988 3.102 3.076 2.931 2.631 2.527 1.93 1989 4.212 4.15 3.904 3.805 3.604 2.338 1990 6.471 6.372 5.916 5.15 4.706 2.984 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 8.857 8.689 8.009 6.755 6.078 3.44 0.0645161290322581 8.007 7.888 7.559 6.662 6.05 3.404 0.0967741935483871 6.769 6.719 6.3 5.443 4.958 3.336 0.129032258064516 6.471 6.372 5.929 5.425 4.912 3.293 0.161290322580645 6.364 6.27 5.916 5.15 4.706 3.247 0.193548387096774 6.171 6.097 5.712 4.995 4.608 3.15 0.225806451612903 5.799 5.69 5.307 4.764 4.484 3.088 0.258064516129032 5.382 5.317 5.049 4.461 4.115 3.012 0.290322580645161 5.366 5.264 4.962 4.353 4 .028 2.984 0.32258064516129 4.795 4.735 4.639 4.277 3.976 2.891 0.354838709677419 4.601 4.529 4.254 3.933 3.882 2.631 0.387096774193548 4.212 4.15 3.904 3.805 3.604 2.463 0.419354838709677 4.116 4.051 3.812 3.371 3.269 2.338 0.451612903225806 3.794 3.729 3 .564 3.334 3.151 2.306 0.483870967741936 3.757 3.7 3.534 3.326 3.096 2.231 0.516129032258065 3.73 3.684 3.473 3.251 3.057 2.167 0.548387096774194 3.687 3.652 3.465 3.061 2.929 2.14 0.580645161290323 3.578 3.516 3.308 3.027 2.822 2.015 0.612903225806452 3.2 91 3.249 3.09 2.824 2.781 1.997 0.645161290322581 3.29 3.244 3.083 2.785 2.699 1.983 0.67741935483871 3.102 3.076 2.939 2.783 2.638 1.93 0.709677419354839 3.098 3.047 2.931 2.631 2.527 1.839 0.741935483870968 3.022 2.986 2.86 2.623 2.486 1.764 0.7741935483 87097 2.675 2.628 2.454 2.262 2.158 1.703 0.806451612903226 2.565 2.51 2.369 2.235 2.136 1.581 0.838709677419355 2.454 2.425 2.302 2.134 2.048 1.502 0.870967741935484 2.359 2.328 2.207 2.087 1.912 1.427146

0.903225806451613 2.312 2.275 2.134 2.008 1.902 1.405 0.935483870967742 2.185 2.155 2.073 1.956 1.855 1.305 0.967741935483871 2.064 2.038 1.991 1.828 1.723 0.9281 0.1 6.7392 6.6843 6.2629 5.4412 4.9534 3.3317 Average of yearly averages: 2.31667 Inputs generated by pe5.pl
- Novemeber 2006 Data used fo r this run: Output File: PAapp Metfile: w14751.dvf PRZM scenario: PAappleSTD_V2.txt EXAMS environment file: pond298.exv Chemical Name: Flutriafol Description Variable Name Value Units Comments Molecular weight mwt 301.3 g/mol Henry's Law Const. henry 1.3E
- 11 atm - m^3/mol Vapor Pressure vapr 3E
- 9 torr Solubility sol 130 mg/L Kd Kd mg/L Koc Koc 322 mg/L Photolysis half

- life kdp days Half
- life Aerobic Aquatic Metabolism kbacw 100 days Halfife Anaerobic Aquatic Metabolism kbacs 365 days Halfife Aerobic Soil Metabolism asm 3247 days Halfife Hydrolysis: pH 7 days Half
- life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI cm Application Rate: TAPP 0.1232 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift DRFT 0.05 fraction of applicati on rate applied to pond Application Date Date 1
- 5 dd/mm or dd/mmm or dd
- mm or dd
-mmm Interval 1 interval 7 days Set to 0 or delete line for single app. app. rate 1 apprate 0.1232 kg/ha Interval 2 interval 7 days Set to 0 or delete line for single app. app. rate 2 apprate 0.1232 kg/ha Interval 3 interval 7 days Set to 0 or delete line for single app. app. rate 3 apprate 0.1232 kg/ha Record 17: FILTRA

IPSCND 1 UPTKF Record 18: PLVKRT

PLDKRT FEXTRC 0.5 Flag for I ndex Res. Run IR EPA Pond Flag for runof

f calc. RUNOFF none none, monthly or total (average of entire run)147



### Appendix C. Aquatic Risk Quotients Table C 1. Summarized Acute (or Instantaneous) and Chronic Aquatic Fish Risk Quotients for Flutriafol Treatm ents in Apple and Soybean S ites 1,2,3 ,4,5 Scenario 6,7,8 Freshwater Fish (Acute) Freshwater Fish

(Chronic) Estuarine/Marine

Fish (Acute) Estuarine/Marine

Fish (Chronic) GENEEC2 and TGAI Ground Spray to Apples <0.01 <0.1 <0.01 <0.1 Aerial Spray to Soybeans (14
- day intervals) <0. 01 <0.1 <0.01 <0.1 Aerial Spray to Soybeans (21
- day intervals) <0.01 <0.1 <0.01 <0.1 Ground Spray to Soybeans (14
- day intervals) <0.01 <0.1 <0.01 <0.1 Ground Spray to Soybeans (21
- day intervals) <0.01 <0.1 <0.01 <0.1

AgDRIFT 9 and Formulation Product (T GAI and Inerts) Ground Spray to Apples 1 0 <0.01 N ot calculated Aerial Spray to Soybeans 1 1 <0.01 N ot calculated Ground Spray to Soybeans 1 2 <0.01 N ot calculated Bold values indicate LOC exceedances: *** RQ exceeds the Acute Risk, Acute Restricted Us e, and Endangered Species LOCs; RQ > 0.5 **RQ exceeds the Acute Restricted Use and Acute Endangered Species LOCs; RQ > 0.1 * RQ exceeds the Acute Endangered Species LOC; RQ > 0.05 + RQ exceeds the Chronic Risk and Endangered Species LOC; RQ >1 1 Detailed calculations of GENEEC2 modeling are provided in Appendix B. 2 Acute and chronic toxicity thresholds for flutriafol TGAI are 33 mg ai/L (LC 50 ) and 4.8 mg ai/L (NOAEC), respectively, for freshwater fish. 3 Acute and chronic toxicity thresholds for flutri afol TGAI are >72.2 mg ai/L (LC 50 ) and >11 mg ai/L (estimated NOAEC value), respectively, for estuarine/marine fish. 4 EECs of AgDRIFT modeling are provided in Section III.4 5 Acute toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 7.9 mg form/L (LC 50 ) and >17 mg form/L (estimated LC 50 value), respectively, for freshwater and estuarine/marine fish. 6 Four ground applications of 0.11 lb ai/A with 7 day intervals to apples. 7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans. 8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds. 1 0 One ground application of 0.92 lb form/A to apples. 1 1 One aerial application of 0.5 lb form/A to soybeans. 1 2 One ground application of 0.5 lb form/A to soybeans.148

Table C 2. Summarized Acute (or Instantaneous) and Chronic Aquatic Invertebrates Risk Quotients for Flutriafol Treatm ents in Apple and Soyb ean Sites 1,2,3 ,4,5 Scenario 6,7,8 Freshwater Inv. (Acute) Freshwater Inv.

(Chronic) Estuarine/Marine

Inv. (Acute) Estuarine/Marine

Inv. (Chronic) GENEEC2 and TGAI Ground Spray to Apples <0.01 <0.1 <0.01 <0.1 Aerial Spray to Soybeans (14
- day intervals ) <0.01 <0.1 <0.01 <0.1 Aerial Spray to Soybeans (21
- day intervals) <0.01 <0.1 <0.01 <0.1 Ground Spray to Soybeans (14
- day intervals) <0.01 <0.1 <0.01 <0.1 Ground Spray to Soybeans (21
- day intervals) <0.01 <0.1 <0.01 <0.1

AgDRIFT 9 and Formulation Produ ct (TGAI and Inerts) Ground Spray to Apples 1 0 <0.01 <0.01 Aerial Spray to Soybeans 1 1 <0.01 <0.01 Ground Spray to Soybeans 1 2 <0.01 <0.01 Bold values indicate LOC exceedances: *** RQ exceeds the Acute Risk, Acute Restricted Use, and Endangered Spec ies LOCs; RQ > 0.5 **RQ exceeds the Acute Restricted Use and Acute Endangered Species LOCs; RQ > 0.1 * RQ exceeds the Acute Endangered Species LOC; RQ > 0.05 + RQ exceeds the Chronic Risk and Endangered Species LOC; RQ >1 1 Detailed calculations of GENEEC 2 modeling are provided in Appendix B. 2 Acute and chronic toxicity thresholds for flutriafol TGAI are 67 mg ai/L (EC 50 ) and 0.31 mg ai/L (NOAEC), respectively, for freshwater invertebrates. 3 Acute and chronic toxicity thresholds for flutriafol TGAI are 25 mg ai/L (EC 50 ) and 0.16 mg ai/L (estimated NOAEC value), respectively, for estuarine/marine invertebrates. 4 EECs of AgDRIFT modeling are provided in Section III.4 5 Acute toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 7.0 5 mg form/L (EC 50 ) and 2.5 mg form/L (estimated EC 50 value), respectively, for freshwater and estuarine/marine invertebrates. 6 Four ground applications of 0.11 lb ai/A with 7 day intervals to apples. 7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans. 8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds. 1 0 One ground application of 0.92 lb form/A to apples. 1 1 One aerial application of 0.5 lb form/A to soybeans. 1 2 One ground application of 0.5 lb form/A to soybeans.149

Table C 3. Summarized Aquatic Plant Risk Quotients for Flutriafol Treatm ents in Apple and Soybean Sites 1,2 ,3,4,5 Scenario 6,7,8 Listed Non - Listed Vascular Non - Vascular Vascular Non - vascular GENEEC2 and %AI in Product Ground Spray to Apples 1.8* 0.32 <0.1 <0.1 Aerial Spray to Soybeans (14
- day intervals) 0.6 <0.1 <0.1 <0.1 Aerial Spray to Soybeans (21
- day intervals) 0.5 <0.1 < 0.1 <0.1 Ground Spray to Soybeans (14
- day intervals) 0.6 <0.1 <0.1 <0.1 Ground Spray to Soybeans (21
- day intervals) 0.5 <0.1 <0.1 <0.1 PRZM/EXAMs and %AI in Product Ground Spray to NC Apples 0.6 0.1 <0.1 <0.1 Ground Spray to OR Apples 0.2 <0.1 <0.1 < 0.1 Ground Spray to PA Apples 0.3 <0.1 <0.1 <0.1 AgDRIFT 9 and Formulation Product (TGAI and Inerts) Ground Spray to Apples 1 0 <0.1 <0.1 <0.1 <0.1 Aerial Spray to Soybeans 1 1 <0.1 <0.1 <0.1 <0.1 Ground Spray to Soybeans 1 2 <0.1 <0.1 <0.1 <0.1 Bold values indicate LOC exceedances: * RQ exceeds the Listed Plant LOCs; RQ > 1.0 **RQ exceeds the Non
- listed Plant LOCs; RQ > 1.0 1 Detailed calculations of GENEEC2 and PRZM/EXAMs modeling are provided in Appendix B. 2 EECs as a result of AGDRIFT modeling are pro vided in the Measures of Exposure section. 3 The non
- listed toxicity threshold (EC 50 ) for the %AI in the formulation product is 0.78 mg ai/L for aquatic vascular plants; while the listed toxicity threshold (surrogate EC 05 ) for the %AI in the product is 0.0 18 mg ai/L. NOAEC <0.13 mg ai/L. 4 The non
- listed toxicity threshold (EC 50 ) is 0.46 mg ai/L for aquatic non
- vascular plants; while the listed toxicity threshold (NOAEC) is 0.1 mg ai/L. 5 Non
- listed toxicity thresholds for flutriafol formulation pro duct (TGAI and inerts) are 6.6 mg form/L (LC 50 ) and 3.8 mg form/L (estimated LC 50 value), respectively, for vascular and nonvascular aquatic plants. 6 Listed toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 0.15 mg form/L (LC 50 ) and 0.84 mg form/L (estimated LC 50 value), respectively, for vascular and nonvascular aquatic plants. 6 Four ground applications of 0.11 lb ai/A with 7 day intervals to apples. 7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans. 8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds. 1 0 One ground application of 0.92 lb form/A to apples. 1 1 One aerial application of 0.5 lb form/A to soybeans. 1 2 One ground application of 0.5 lb form/A to soybeans.150



### Appendix D. T - REX (Terrestrial Exposure Model for Birds and Mammals) Input and Output This appendix describes how the model, T
- REX version 1.2.3, estimates the follow ing: (1) residue concentrations on selected food items (mg/kg
- dietary item); (2) dose
- based EECs (mg/kg
- bw) from dietary

concentrations on selected food items; (3) adjusted toxicity values; and risk quotients for birds and mammals. (1) Calculation of dietary concentrations on selected food items T
- REX calculates the pesticide residue concentrations on each selected food item on a daily interval for one ye ar. When multiple applications are modeled, residue concentrations resulting from the final application and remaining residue from previous applications are summed. The maximum concentration calculated out of the 365 days is returned as the EEC used to estimate potential risk to birds and mammals as described below. Dissipation of a chemical applied to foliar surfaces for single or multiple applications is calculated assuming a first order decay rate from the following first order rate equation:

C t = C 0 e - kt or in log form: ln(C t) = ln(C 0 )(
- kT) Where: C t = concentration, parts per million ( mg/kg ), at time T. C 0 = concentration ( mg/kg ), present initially (on day zero) on the surface of selected food items. C 0 is calculated by

m ultiplying the application rate, in pounds active ingredient per acre, by 240 for short grass, 110 for tall grass, and 135 for broad
- leafed plants/small insects and 15 for fruits/pods/large insects for upper bound residue levels. M ean residue levels are derived by multiplying the application rate by 85 for short grass, 36 for tall grass, and 45 for broad
- leafed plant s/small insects and 7 for fruits/pods/seeds/large insects. Residue levels are based on work by Hoerger and Kenaga (1972) as mo dified by Fletcher et al
. (1994). Additional applications are converted from pounds active ingredient per acre to ppm o n the plant surface and the additional mass added to the mass of the chemical still present on the surfaces on the day of application. k = Exponential rate constant = ln 2 ÷ foliar dissipation half
- life. Wh en scientifically valid, statistically robust data are not available, EFED recommends the using a default foliar dissipation half
- life value of 35 day s. T he use of the 35
- day h alf
- life is based on the highest reported value (36.9 days), as reported by Willis and McDowell (1987). t = time, in day s, since the st art of the simulation. Th e initial application is on day 0. The simulation is designed to run for 365 days. The dietary

concentrations estimated using the above methodology may be used directl y to calculate risk quotients, but may also be used to calcul ate dose
- based EECs (mg/kg
- bw) for various size classes of mammals and birds as described below.151

(2) Calculating EEC Equivalent Doses based on Estimated Dietary Concentrations on Selected Bird and Mammal Food Items EECs (mg/kg
- bw) for various size cl asses of mammals and birds may be calculated based on the dietary residue concentrations derived using the equations presented above. To allow for this ty pe of anal ys is, the EECs and toxicity values are adjusted based on food intake and body weight differences so that they

are comparable for a given weight class of animal. The size classes assessed are small (20
- gram), medium (100
- gram), and large (1000
- gram) birds, and small (15
- gram), medium (35
- gram), and large (1000
- gram) mammals. Equations used to c alculate food intake (grams/day) and to adjust toxicity values for dose
- based risk quotients are presented below. Calculating Food Intake for Different Size Classes of Birds and Mammals: Daily food intake (g/day) is assumed to correlate with body weight using the following empirically

derived equation (U.S. EPA, 1993):

Avian consumption F BW W 

 0 648 1 0 651

. * ( ) . where: F = food intake in grams of fresh weight per day (g/day) BW = body

mass of animal (g) W = mass fraction of water in the food (EF ED value = 0.8 for birds and herbivorous mammals, 0.1 for granivorous mammals) Based on this equation, a 20
- gram bird would consume 22.8 grams of food daily (114% of its body weight), a 100
- gram bird would consume 65 grams of food dail y (65% of its body w eight daily), and 1000
- gram bird would consume 290 grams of food dail y (29% of its body weight). These data, together with the residue concentrations (mg/kg
- food item) on selected food items calculated from the Kenaga nomogram, are used to estimate the do se (mg/kg
- bw) of residue consumed b y the three size classes of birds as discussed below. Using a 20
- gram bird as an example, a dietary

concentration of 100 mg/kg
- diet (ppm) x 1.14 kg diet/kg bw (114%) would result in an equivalent dose
- based EEC of 114 mg/kg
- bw. T
- REX calculates food intake based on dry weight and wet weight of food items. The dose
- based assessment uses the wet weight food consumption values by assuming that dietary items are 80% water b y weight. However, if dietary items of a species b eing assessed are known, then a refined dose
- based EEC can be calculated using appropriate water fractions of the food items. A similar relationship between body weight and food intake has been derived for mammals (U.S. EPA 1993): Mammalian food cons umption (g/day)152 F BW

W 

 0 621 1 0 564

. * ( ) . where: F = food intake in grams of fresh weight per day (g/day) BW = body

mass of animal (g) W = mass fraction of water in the food (EFED value = 0.8 for birds and herbivorous mammals, 0.1 for granivorous mamma ls) The scaling factors result in a percent body weight consumed presented in the following table for each weight class of mammal. These values are used in the same manner described for birds to calculate dose
- based EECs (mg/kg
- bw). Note the difference in food intake of granivores compared with herbivores and insectivores. This is caused b y the difference in the assumed mass fraction of water in their diets.

Organismand body weight Food intake (g day - 1 ) a Percent body weight

consumed (day - 1 ) a 15 g 14.3 / 3.2 95 / 21 35 g 23 / 5.1 66 / 15 1000 g 150 / 34 15 / 3 a The first number in this column is specific to herbivores/insectivores. The second number is for granivores. These groups have markedly different consumption requirements. T
- REX calcul ates food intake based on dry weight and wet weight of food items (wet weight is used for RQ calculations). The dose
- based assessment uses the wet weight food consumption values by assuming that dietary

items are 80% water by

weight (10% for granivores). However, if dietary items of a species being assessed are known, then a refined dose
- based EEC can be calculated using appropriate water fractions of the food items. (3) Calculating Adjusted Toxicity Values The dose
- based EECs (mg/kg
- bw) derived above are compared with LD 50 or NOAEL (mg/kg
bw) values from acceptable or supplemental toxicity studies that are adjusted for the size of the animal tested compared with the size of the animal being assessed (e.g., 20
- gram bird). These exposure values are pre sented as mass of pesticide consumed per kg body weight of the animal being assessed (mg/kg
- bw). EECs and toxicity values are relative to the animal’s body weight (mg residue/kg bw) because consumption of the same mass of pesticide residue results in a hi gher body burden in smaller animals compared with larger animals. For birds, only acute values (LD 50 s) are adjusted because dose
- based risk quotients are not calculated for the chronic risk estimation. Adjusted mammalian LD 50 s and reproduction NOAELs (mg/kg
- bw) are used to calculate dose
- based acute and chronic risk quotients for 15
- , 35
- , and 1000
- gram mammals. The following equations are used for the adjustment (U.S. EPA 1993): Adjusted avian LD 50 :153 Adj LD LD AW

TW x

. ( ) 50 50 1
        where: Adj. LD 50 = a djusted LD 50 (mg/kg
-bw) calculated by the equation LD 50 = endpoint reported from bird study (mg/kg
-bw) TW = body weight of tested animal (178g bobwhite; 1580g mallard; 350g rat) AW = body

w eight of assessed animal ( avian : 20g, 100g, and 1000g) x = Mineau s caling factor for birds; EFED default 1.15 Adjusted mammalian NOAELs and LD 50 s (note that the same equation is used to adjust the NOAEL): Adj NOAEL or LD NOAEL or LD TW AW . (
. ) 50 50 0 25
 

    
where: Adj. NOAEL or LD 50 = adjusted NOAEL or LD 50 (mg/kg
-bw) NOAEL or LD 50 = endpoint reported from bird study (mg/kg
-bw) TW = body weight of tested animal (350g rat) AW = body

w eight of assessed animal (15g, 35g, 1000g) (4) Calculating Risk Quotients Two ty pes of risk quotients are calculated by T
- REX based on the estimated dietary residue concentrations determined from the Kenaga nomogram: (1) dietary based RQs; and (2) dose based RQs. These RQs are not equivalent. Dietary risk quotients are calculated by directl y comparing the concentration of a pesticide administered (or estimated to be administered) to experimental animals in the diet in a toxicity study to the concentration estimated to be on selected food items. These risk quotients do not account for the fact that smaller
- sized animals need to consume more food relative to their body weight than larger animals or those differential amounts of food are consumed depending on the water content and nutritive value of the food. The dose
- based risk quotients do account for these factors. The dose
- based RQs incorporate the ingestion rate
- adjusted exposure from the various food items to the different weight classes of birds and the weight class
- scaled toxicity endpoints. Formulas presented below are used to calculate dose
- based and dietary based risk quotients:154

Duration Dose or

Dietary RQ Surrogate

Organism Equation Ac ute Dose
-based Birds and mammals Ac ute Daily Exposure (mg/kg
-bw) / adjusted LD 50 (mg/kg
bw) Dietary
-based Birds Kenaga EEC (mg/kg
- food item) / LC 50 (mg/kg
- diet) Chronic Dietary
-based Birds and mammals EEC ( mg/kg
- food item) / NOAEC (mg/kg
- diet) Dose
-based Mammals only EEC (mg/kg
-bw) / Adjusted NOAEL (mg/kg
-bw) These risk quotients are compared to the Agency ’s L OCs to determine if risk is greater than EFED’s concern level. 

### Soy bean Use – Upper Bound (3 x 0.06 lb ai/A x 21D Interval) Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Soy beans Formulation: TopGuard Ap plication Rate: 0.06 lbs ai/A

Half- life: 35 days Ap plication Interval: 21 days Maximum # A pps./Year: 3 appli cations Length of Simulation: 1 year Endpoints
Av ian Partridge LD50 (mg/kg - bw) 616.00 Ma llard duck LC50 (mg/kg - diet) 4062.00 Ma llard duck NOA EL(mg/kg - bw) 0.00 Ma llard duck NOA EC (mg/kg - diet) 39.20
Ma mmals Mouse LD50 (mg/kg - bw) 179 .00 LC5 0 (mg/kg - diet) 0.00 Rat NOA EL (mg/kg - bw) 20 . 6 0 Rat NOA EC (mg/kg - diet) 240.0 0 Dietary - Based EECs

Food Items Upper Bound EEC (mg ai/kg) Me an EEC

(mg ai/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 30.2 13.8 17.0 1.9 10.7

4.5 5.7 0.9155



### AV IA N EECs and ADJUSTED LD50s
Avian Class Body

Weight (g) Ingestion

(Fdry) (g bw/day) Ingestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Small 20 5 23 114 2.28E - 02 Mi d 100 13 65 65 6.49E - 02 Large 1000 58 291 29 2.9 1E - 01 Avian Body Weight (g) Adjusted LD50 (mg/kg - bw ) 20 388.79 100 494.95 1000 699.13 

## Dose - based EECs (mg/kg - bw )

Food items Av ian Classes and Body Weights small mid large 20 g 100 g 1000 g Upper Bound EEC (mg/kg) Short Grass Tall Grass S m. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 34.4 19.6 8.8 15.8 9.0 4.0 19.3 11.0 4.9 2.2 1.2 0.6 Me an EEC (mg/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 12.2 7.0 3.1 5.2 2.9 1.3 6.5 3.7 1.6 1 .0 0.6 0.3 

### MA MMA LI AN EECs and A DJUSTED LD50s
Mammalian Class Body

Weight Ingestion

(Fdry) (g bwt/day) Ingestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Herbivores/ insectivores 15 3 14 95 1.43E - 02 35 5 23 66 2.31E - 02 1000 31 153 15 1.53E - 01 Granivores 15 3 3 21 3.18E - 03 35 5 5 15 5.13E - 03 1000 31 34 3 3.40E - 02156

Mammalian Class Body Weight Adjusted LD50 Adjusted NOA EL Herbivores/ insectivores 15 192.35 45.28 35 155.63 36.63 1000 67.31 15.84 Granivores 15 192.35 45. 28 35 155.63 36.63 1000 67.31 15.84 

### Dose - based EECs (mg/kg - bw) Mammalian Class es and Body Weight Herbivores and Insectivores Gra n i vores 15 g 35 g 1000 g 15 g 35 g 1000 g Upper Bound EECs (mg ai/kg) Short Grass 28.76 19.88 4.61 Tall G rass 13.18 9.11 2.11 Broadleaf plants and small insects 16.18 11.18 2.59 Fruits/pods/seeds/large insects 1.80 1.24 0.29 0.40 0.28 0.06 Me an EECs (mg ai/kg) Short Grass 10.15 7.05 1.60 Tall Grass 4.30 2.99 0.68 Broadleaf plants an d small insects 5.37 3.73 0.85 Fruits/pods/seeds/large insects 0.84 0.58 0.13 0.18 0.13 0.03 

### RESULTS

– Upper Bound EECs and RQs Table D1 . Upper Bound Kenaga, Acute Avian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 34.36 0.09 15.75 0.04 19.33 0.05 2.15 0.01 100 494.95 19.59 0.04 8.98 0.0 2 11.02 0.02 1.22 0.00 1000 699.13 8.77 0.01 4.02 0.01 4.93 0.01 0.55 0.00 Bold value indicates LOC exceedance Table D2 . Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 30.17 0.01 13.83 0.00 16.97 0.00 1.89 0.00 Size class not used for dietary risk quotients Bold value indicates LOC exce edance157

Table D3 . Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large In sects EEC RQ EEC RQ EEC RQ EEC RQ 39 30.17 0.77 13.83 0.35 16.97 0.43 1.89 0.05 Size class not used for dietary risk quotients Bold values indicate LOC exceedances Table D4 . Upper Bound Kenaga, Acute Mammalian Dose - Based Risk Quotients (3 Applicatio ns @ 0.06 lb ai/A with 21 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 28.76 0.15 13.18 0.07 16.18 0.08 1.80 0.01 0.40 0.00 35 155.63 19.88 0.13 9.11 0.06 11.18 0.07 1.24 0.01 0.28 0.00 1000 67.31 4.61 0.07 2.11 0.03 2.59 0.04 0.29 0.00 0.06 0.00

Table D5 . Upper Bound Kenaga, Chronic Mamm alian Dietary Based Risk Quotients (3 Applicat ions @ 0.06 lb ai/A with 21 Day Intervals) NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 30.17 0.13 13.83 0.06 16.97 0.07 1.89 0.01 Size class not used for dietary risk quotients

Table D6 . Upper Bound Kenaga, Chronic Mamm alian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Pl ants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 28.76 0.64 13.18 0.29 16.18 0.36 1.80 0.04 0.40 0.01 35 36.63 19.88 0.54 9.11 0.25 11.18 0.31 1.24 0.03 0.28 0.01 1000 15.84 4.61 0.29 2.11 0 .13 2.59 0.16 0.29 0.02 0.06 0.00 Bold values indicate LOC exceedances158



### Soy bean Use – Mean EECs and RQs (3 x 0.06 lb ai/A x 21 D intervals)
Table D7 . Mean Kenaga, Acute Avian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Interv als)

Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 12.17 0.031 5.15 0.013 6.44 0.017 1.00 0.003 100 494.95 6.94 0.014 2 .94 0.006 3.67 0.007 0.57 0.001 1000 699.13 3.11 0.004 1.32 0.002 1.64 0.002 0.26 0.000

Table D8 . Mean Kenaga, Subacute Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Gr ass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 10.68 0.003 4.53 0.001 5.66 0.001 0.88 0.000 Size class not used for dietary risk quotients

Table D9 . Mean Kenaga, Chronic Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 39 10.68 0.273 4.53 0.115 5.66 0.144 0.88 0.022 Size class not used for dietary risk quotients Bold value indicates LOC exceedance159

Table D10 . Mean Kenaga, Acute Mam malian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 10.19 0.053 4.31 0.022 5.39 0.028 0.84 0.004 0.19 0.00 35 155.63 7.04 0.045 2.98 0. 019 3.73 0.024 0.58 0.004 0.13 0.00 1000 67.31 1.63 0.024 0.69 0.010 0.86 0.013 0.13 0.002 0.03 0.00

Table D11 . Mean Kenaga, Chronic Mamm alian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)
NOAEC ( mg/kg - diet) EEC s and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 10.68 0.045 4.53 0.019 5.66 0.024 0.88 0.004 Size class not used for dietary risk quotients

Table D12 . Mean Kena ga, Chronic Mamm alian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 10.19 0.225 4.31 0.095 5.39 0.119 0.84 0.019 0.19 0.00 35 36.63 7.04 0.192 2.98 0.081 3.73 0.102 0.58 0.016 0.13 0.00 1000 15.84 1.63 0.103 0.69 0.044 0.86 0.055 0.13 0.008 0.03 0.00160



### Soy bean Use – U pper Bound (3 x 0.06 lb ai/A x 14D Interval) Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Soy beans Formulation: TopGuard Ap plication Rate: 0.06 lbs ai/A

Half- life: 35 days Ap plication Interval: 14 days Maximum # A pps ./Year: 3 applications Length of Simulation: 1 year Endpoints
Av ian Partridge LD50 (mg/kg - bw) 616.00 Ma llard duck LC50 (mg/kg - diet) 4062.00 Ma llard duck NOA EL(mg/kg - bw) 0.00 Ma llard duck NOA EC (mg/kg - diet) 39.20
Ma mmals Mouse LD50 (mg/kg - bw ) 179 .00 LC50 (mg/kg - diet) 0.00 Rat NOA EL (mg/kg - bw) 20 . 6 0 Rat NOA EC (mg/kg - diet) 240.0 0 Dietary - Based EECs

Food Items Upper Bound EEC (mg ai/kg) Me an EEC (mg ai/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 33.58 15.39 18.89 2.10 11.89 5.04 6.30 0.98 

### AV IA N EECs and ADJUSTED LD50s
Avian Class Body

Weight (g) Ingestion

(Fdry) (g bw/day) Ingestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Small 20 5 23 114 2.28E - 02 Mi d 100 13 65 65 6.49 E - 02 Large 1000 58 291 29 2.91E - 01 Avian Body Weight (g) Adjusted LD50 (mg/kg - bw ) 20 388.79 100 494.95 1000 699.13161



## Dose - based EECs (mg/kg - bw )

Food items Av ian Classes and Body Weights small mid large 20 g 100 g 1000 g Upper Bound EEC (m g/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 38.25 21.81 9.77 17.53 10.00 4.48 21.51 12.27 5.49 2.39 1.36 0.61 Me an EEC (mg/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 13.56 7.73 3.45 5.74 3.27 1.46 7.18 4.09 1.83 1.12 0.64 0.28 

### MA MMA LI AN EECs and A DJUSTED LD50s
Mammalian Class Body

Weight Ingestion

(Fdry) (g bwt/day) Ingestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Herbivores/ insectivores 15 3 14 95 1.43E - 02 35 5 23 66 2.31E - 02 1000 31 153 15 1.53E - 01 Granivores 15 3 3 21 3.18E - 03 35 5 5 15 5.13E - 03 1000 31 34 3 3.40E - 02

Mammalian Class Body Weight Adjusted LD50 Adjusted NOA EL Herbivores/ insectivores 15 192.35 45.28 35 155 .63 36.63 1000 67.31 15.84 Granivores 15 192.35 45.28 35 155.63 36.63 1000 67.31 15.84162



### Dose - based EECs (mg/kg - bw) Mammalian Class es and Body Weight Herbivores and Insectivores Granivores 15 g 35 g 1000 g 15 g 35 g 1000 g Upper Bou nd EECs (mg ai/kg) Short Grass 32.02 22.13 5.13 Tall Grass 14.68 10.14 2.35 Broadleaf plants and small insects 18.01 12.45 2.89 Fruits/pods/seeds/large insects 2.00 1.38 0.32 0.44 0.31 0.07 Me an EECs (mg ai/kg) Short Grass 11.30 7.85 1.78 Tall Grass 4.79 3.32 0.76 Broadleaf plants and small insects 5.98 4.16 0.94 Fruits/pods/seeds/large insects 0.93 0.65 0.15 0.21 0.15 0.03 

### RESULTS

– Upper Bound EECs and RQs Table D1 . Upper Bound Kenaga, Acute Avian Dose - Ba sed Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 38 .3 0.1 17.5 0.05 21.5 0.06 2.4 0.01 100 494.95 21.8 0.05 10 0.02 12.3 0.03 1.4 0.00 1000 699.13 9.8 0.01 4.5 0.01 5.5 0.01 0.6 0.00 Bold value indicates LOC exceedance Table D2 . Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 33.6 0.01 15.4 0.00 18.9 0.00 2.1 0.00 Size class not used for dietary risk quotients ; Bold value indicates LOC exceedance Table D3 . Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadl eaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 39 33.6 0.86 15.4 0.39 18.9 0.48 2.1 0.05 Size class not used for dietary risk quotients ; Bold values indicate LOC exceedances163

Table D4 . Upper Bound Kenaga, Acute Mam malian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 32 0.17 14.5 0.08 18 0.09 2 0.01 0.4 0.00 35 155.63 22.1 0.14 10.1 0.07 12.5 0.08 1.4 0.01 0.3 0.00 1000 67.31 5.1 0.08 2.4 0.03 2.9 0.04 0.32 0.00 0.07 0.00

Table D5 . Upper Bound Kenaga, Chronic Mamm alian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals) NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 33.6 0.14 15.4 0.06 1 8.9 0.08 2.1 0.01 Size class not used for dietary risk quotients

Table D6 . Upper Bound Kenaga, Chronic Mamm alian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 32.0 0.08 14.7 0.04 18 0.05 2 0.01 0.44 0.00 35 36.63 22.1 0.07 10.1 0.03 12.5 0.04 1.4 0.00 0.31 0.00 1000 15.8 4 5.1 0.04 2.4 0.02 2.9 0.02 0.32 0.00 0.07 0.00 Bold values indicate LOC exceedances164



### Soy bean Use – Mean EECs and RQs (3 x 0.06 lb ai/A x 14D Intervals)
Table D7 . Mean Kenaga, Acute Avian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 13.6 0.04 5.7 0.02 7.2 0.02 1.1 0.00 100 494.95 7.7 0. 02 3.3 0.01 4.1 0.01 0.64 0.00 1000 699.13 3.5 0.01 1.5 0.00 1.8 0.00 0.28 0.00

Table D8 . Mean Kenaga, Subacute Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Grass Broa dleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 11.9 0.00 5.0 0.00 6.3 0.00 0.98 0.00 Size class not used for dietary risk quotients

Table D9 . Mean Kenaga, Chronic Avian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 39 11.9 0.3 5.0 0.13 6.3 0.16 0.98 0.02 Size c lass not used for dietary risk quotients Bold value indicates LOC exceedance165

Table D10 . Mean Kenaga, Acute Mam malian Dose - Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Sh ort Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 11.3 0.06 4.8 0.02 6 0.03 0.9 0.00 0.2 0.00 35 155.63 7.8 0.05 3.3 0.02 4.2 0.03 0.7 0.00 0.14 0.00 1000 67 .31 1.8 0.03 0.8 0.01 0.96 0.01 0.2 0.00 0.03 0.00

Table D11 . Mean Kenaga, Chronic Mamm alian Dietary Based Risk Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)
NOAEC ( mg/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 11.9 0.05 5.0 0.02 6.3 0.03 0.98 0.00 Size class not used for dietary risk quotients

Table D12 . Mean Kenaga, Chronic Mamm alian Dose - Based Risk Quotients (3 Appli cations @ 0.06 lb ai/A with 14 Day Intervals)
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 11.3 0.25 4 .8 0.1 6 0.13 0.9 0.02 0.2 0.00 35 36.63 7.9 0.21 3.3 0.09 4.2 0.11 0.7 0.02 0.15 0.00 1000 15.84 1.8 0.11 0.8 0.05 0.9 0.06 0.2 0.01 0.03 0.00166



### Ap ple Use Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Ap ples F ormulation: TopGuard Ap plication Rate: 0. 11 lbs ai/A

Half- life: 35 days Ap plication Interval: 7 days Maximum # A pps./Year: 4 applications Length of Simulation: 1 year Endpoints
Av ian Partridge LD50 (mg/kg - bw) 616.00 Ma llard duck LC50 (mg/kg - diet) 4062.00 Ma llard duck NOA EL(mg/kg - bw) 0.00 Ma llard duck NOA EC (mg/kg - diet) 39.20
Ma mmals Mouse LD50 (mg/kg - bw) 179 .00 LC50 (mg/kg - diet) 0.00 Rat NOA EL (mg/kg - bw) 20 . 6 0 Rat NOA EC (mg/kg - diet) 240.0 0 Dietary - Based EECs

Food Items Upper B ound EEC (mg ai/kg) Me an EEC

(mg ai/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 86.81 39.79 48.83 5.43 30.74

13.02 16.28 2.53 

### AV IA N EECs and ADJUSTED LD50s
Avian Class Body

Weight (g) Ingestion

(Fdry) (g bw/day) I ngestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Small 20 5 23 114 2.28E - 02 Mi d 100 13 65 65 6.49E - 02 Large 1000 58 291 29 2.91E - 01 Avian Body Weight (g) Adjusted LD50 (mg/kg - bw ) 20 388.79 100 494.95 1000 699.13167



## Dose - based EECs ( mg/kg - bw )

Food items Av ian Classes and Body Weights small mid large 20 g 100 g 1000 g Upper Bound EEC (mg/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 98.87 56.38 25.24 45.31 25.84 11.57 55.61 31.71 14.20 6.18 3.52 1.58 Me an EEC (mg/kg) Short Grass Tall Grass Sm. Insects, Broadleaf Plants Lg. Insects, Fruits, Pods 35.01 19.97 8.94 14.83 8.46 3.79 18.54 10.57 4.73 2.88 1.64 0.74 

### MA MMA LI AN EECs and A DJUSTED LD50s
Mammalian Class Body

Weight Inges tion

(Fdry) (g bwt/day) Ingestion

(Fwet) (g/day) % body

w gt consumed FI

(kg - diet/day) Herbivores/ insectivores 15 3 14 95 1.43E - 02 35 5 23 66 2.31E - 02 1000 31 153 15 1.53E - 01 Granivores 15 3 3 21 3.18E - 03 35 5 5 15 5.13E - 03 1000 31 34 3 3.40E - 02 Mammalian Class Body Weight Adjusted LD50 Adjusted NOA EL Herbivores/ insectivores 15 192.35 45.28 35 155.63 36.63 1000 67.31 15.84 Granivores 15 192.35 45.28 35 155.63 36.63 1000 67.31 15.84168



### Dose - based EECs (mg/kg - bw) Mam malian Class es and Body Weight Herbivores and Insectivores Granivores 15 g 35 g 1000 g 15 g 35 g 1000 g Upper Bound EECs (mg ai/kg) Short Grass 82.76 57.20 13.26 Tall Grass 37.93 26.22 6.08 Broadleaf plants and small insects 46.55 32. 18 7.46 Fruits/pods/seeds/large insects 5.17 3.58 0.83 1.15 0.79 0.18 Me an EECs (mg ai/kg) Short Grass 29.31 20.26 4.70 Tall Grass 12.41 8.58 1.99 Broadleaf plants and small insects 15.52 10.73 2.49 Fruits/pods/seeds/large i nsects 2.41 1.67 0.39 0.54 0.37 0.09 

### RESULTS – Upper Bound EECs and RQs Table D 13. Upper Bound Kenaga, Acute Avian Dose - Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Interval s )
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Gra ss Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 98.87 0.25 45.31 0.12 55.61 0.14 6.18 0.02 100 494.95 56.38 0.11 25.84 0.05 31.71 0.06 3.52 0.01 1000 699.13 25.24 0.04 11.57 0.02 1 4.20 0.02 1.58 0.00 Bold value indicates LOC exceedance Table D 14. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 86.81 0.02 39.79 0.01 48.83 0.01 5.43 0.00 Size class not used for dietary risk quotients Bold value indicates LOC exceedance169

Table D 15. Upper Bound Kenaga, Chroni c Avian Dietary Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Interval s )

NOAEC (m g/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 39 86.81 2. 21 39.79 1.01 48.83 1.25 5.43 0.14 Size class not used for dietary risk quotients Bold values indicate LOC exceedances

Table D 16. Upper Bound Kenaga, Acute Mammalian Dose - Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Interval s )
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 82.76 0.43 37.93 0.20 46.55 0.24 5.17 0.03 1.15 0.01 35 155.6 3 57.20 0.37 26.22 0.17 32.18 0.21 3.58 0.02 0.79 0.01 1000 67.31 13.26 0.20 6.08 0.09 7.46 0.11 0.83 0.01 0.18 0.00

Table D 17. Upper Bound Kenaga, Chronic Mamm alian Dietary Based Risk Quotients ( 4 Applications @ 0.11 lb ai/A with 7 Day Interval s ) NOAEC (m g/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 86.81 0.36 39.79 0.17 48.83 0.20 5.43 0.02 Size class not used for dietary risk quotients170 Table D 18. Upper Bound Kenaga, Chronic Mamm alian Dose - Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Interval s )
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 82.76 1.83 37.93 0.84 46.55 1.03 5.17 0.11 1.15 0.03 35 36.63 57.20 1.56 26.22 0.72 32.18 0.88 3.58 0.10 0.79 0.02 1000 15.84 13.26 0.84 6.08 0.38 7.46 0.47 0.83 0.05 0.18 0 .01 Bold values indicate LOC exceedances 

### Ap ple Use – Mean EECs and RQs

Table D 19. Mean Kenaga, Acute Avian Dose - Based Risk Quotients ( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 20 388.79 35.01 0.090 14.83 0.038 18.54 0.048 2.88 0.007 100 494.95 19.97 0.040 8.46 0.017 10.57 0.021 1.64 0.003 1000 699.13 8.94 0.013 3.79 0. 005 4.73 0.007 0.74 0.001

Table D 20. Mean Kenaga, Subacute Avian Dietary Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

LC50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 4062 30.74 0.008 13.02 0.003 16.28 0.004 2.53 0.001 Size class not used for dietary risk quotients171

Table D 21. Mean Kenaga, Chronic Avian Dietary Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

NOAEC (m g/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 39 30.74 0.784 13.02 0.332 16.28 0.415 2.53 0.065 Size class not used for dietary ris k quotients Bold value indicates LOC exceedance

Table D 22. Mean Kenaga, Acute Mammalian Dose - Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)
Size Class (gram s) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 192.35 29.31 0.152 12.41 0.065 15.52 0.081 2.41 0.013 0.54 0.00 35 155.63 20.26 0.130 8.58 0.055 10.73 0.069 1.67 0.011 0.37 0.00 1000 67.31 4.70 0.070 1.99 0.030 2.49 0.037 0.39 0.006 0.09 0.00
Table D 23. Mean Kenaga, Chronic Mamm alian Dietary Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)
NOAEC (m g/kg - diet) EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ S ma ll Insects Fruits/Pods/

Seeds/ Large Insects EEC RQ EEC RQ EEC RQ EEC RQ 240 30.74 0.128 13.02 0.054 16.28 0.068 2.53 0.011 Size class not used for dietary risk quotients

Table D 24. Mean Kenaga, Chronic Mamm alian Dose - Based Risk Quotients

( 4 Applications @ 0.11 lb ai/A with 7 Day Intervals)
Size Class (gram s) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants/ Sm all Insects Fruits/Pods/

Seeds/ Large Insects Granivores EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 45.28 29.31 0 .647 12.41 0.274 15.52 0.343 2.41 0.053 0.54 0.01 35 36.63 20.26 0.553 8.58 0.234 10.73 0.293 1.67 0.046 0.37 0.01 1000 15.84 4.70 0.296 1.99 0.126 2.49 0.157 0.39 0.024 0.09 0.01172



### Appendix E. Terrestrial Plants Exposure Modeling and Results (TerrPlant v 1.2.2) 1. Ground Application of 0.06 lbs ai/A to Soybeans Table E 1. Chemical Identity. Chemical Name Flutriafol 125 g/l SC PC code 128940 Use Soybeans Ap plication Method Ground Ap plication Form liquid Solubility in Water (ppm) 130 mg/ L Table E 2. Input parameters used to derive EECs. Input Parameter Symbol Value Units Application Rate A 0.06 lbs ai/A Incorporation I 1 none Runoff Fraction R 0.05 none Drift Fraction D 0.01 none Table E 3. EECs fo r Flutriafol 125 g/l SC. Units in lbs ai/A .

Description Equation EEC Runoff to dry areas (A/I)*R 0.003 Runoff to semi - aquatic areas (A/I)*R*10 0.03 Spray drift A*D 0.0006 Total for dry areas ((A /I)*R)+( A*D) 0.0036 Total for semi - aquatic areas ((A /I)*R*10)+( A*D) 0.0306 Table E 4. Plant survival and growth data used for RQ derivation. Units are in lbs ai/A . Seedling Emergence Vegetative Vigor Plant type EC 25 NOA EC EC 25 NOA EC Monocot >0.12 > 0.12 >0.12 > 0.12 Dicot >0.12 > 0.12 >0.12 > 0.12 Table E 5. RQ values for plants in dry and semi - aquatic areas exposed to Flutriafol 125 g/l SC through runoff and/or spray drift.*

Plant Type Listed Status Dry Semi - Aq uatic Spray Drift Monocot non - listed <0.1 <0. 26 <0.1 Mono cot listed <0.1 <0. 26 <0.1 Dicot non - listed <0.1 <0. 26 <0.1 Dicot listed <0.1 <0.26 <0.1 *If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group. INC - inconclusive173

2. Aerial Application of 0.06 lbs ai/A to Soybeans Table E6 . Chemical Identity. Chemical Name Flutriafol 125 g/l SC PC code 128940 Use Soybeans Ap plication Method Aerial Ap plication Form liquid Solubility in Water (ppm) 130 mg/L Table E7 . Input parameters used to deri ve EECs. Input Parameter Symbol Value Units Application Rate A 0.06 Lbs ai/A Incorporation I 1 none Runoff Fraction R 0.05 none Drift Fraction D 0.05 none Table E8 . EECs for Flutriafol 125 g/l SC. Units in y.

Description Eq uation EEC Runoff to dry areas (A/I)*R 0.003 Runoff to semi - aquatic areas (A/I)*R*10 0.03 Spray drift A*D 0.003 Total for dry areas ((A /I)*R)+( A*D) 0.006 Total for semi - aquatic areas ((A /I)*R*10)+( A*D) 0.033 Table E9 . Plant sur

vival and growth data used for RQ derivation. Units are in Lbs ai/A .

Seedling Emergence Vegetative Vigor Plant type EC 25 NOA EC EC 25 NOA EC Monocot >0.12 > 0.12 >0.12 > 0.12 Dicot >0.12 > 0.12 >0.12 > 0.12 Table E10 . RQ values for plants in d ry and semi - aquatic areas exposed to Flutriafol 125 g/l SC through runoff and/or spray drift.* Plant Type Listed Status Dry Semi - Aq uatic Spray Drift Monocot non - listed <0.1 <0. 28 <0.1 Monocot listed <0.1 <0. 28 <0.1 Dicot non - listed <0.1 <0. 28 <0.1 Di cot listed <0.1 <0. 28 <0.1 *If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group. INC - inconclusive174

3. Ground Application of 0.11 lbs ai/A to Apples Table E11 . Chemical Identity. Chemical Name Flutria fol 125 g/l SC PC code 128940 Use Ap ples Ap plication Method Ground Ap plication Form liquid Solubility in Water ( mg/L ) 130 mg/L Table E12 . Input parameters used to derive EECs. Input Parameter Symbol Value Units Applicati on Rate A 0.11 lbs ai/A Incorporation I 1 none Runoff Fraction R 0.05 none Drift Fraction D 0.01 none Table E1 3. EECs for Flutriafol 125 g/l SC. Units in lbs ai/A .

Description Equation EEC Runoff to dry areas (A/I)*R 0.0055 Runoff to semi - aquatic areas (A/I)*R*10 0.055 Spray drift A*D 0.0011 Total for dry areas ((A /I)*R)+( A*D) 0.0066 Total for semi - aquatic areas ((A /I)*R*10)+( A*D) 0.0561 Table E1 4. Plant survival and growth data used for RQ derivation. Units are in lbs ai/A . Seedling Emergence Vegetative Vigor Plant type EC 25 NOA EC EC 25 NOA EC Monocot >0.12 > 0.12 >0.12 > 0.12 Dicot >0.12 > 0.12 >0.12 > 0.12 Table E1 5. RQ values for plants in dry and semi - aquatic areas exposed to Flutriafol 125 g/l SC through runoff and/or spray drift.*

Plant Type Listed Status Dry Semi - Aq uatic Spray Drift Monocot non - listed <0.1 < 0.47 <0.1 Monocot listed <0.1 < 0.47 <0.1 Dicot non - listed <0.1 < 0.47 <0.1 Dicot listed <0.1 < 0.47 <0.1 *If RQ > 1.0, th e LOC is exceeded, resulting in potential for risk to that plant group.175



### Appendix F. Ecological Effects Data In this risk assessment, surrogate test species of birds, mammals, fish, aquatic and terrestrial invertebrates and plants are used to estimate treatment
- related direct effects on acute mortality or immobility

and chronic reproduction, growth, and survival of non
- target species. Toxicity test values ( i.e. , measures of effect) are derived from the results of registrant
- required animal toxicity studies that are consistent with and meet toxicity testing guidelines (FIFRA 40 CFR Part 158 and 160). Toxicity

tests include short
- term acute, subacute, and reproduction/chronic studies that progress from basic laboratory tests to applied field studies. In addition, avian species are used as surrogates for reptiles while freshwater fish species are used as surrogates for aquatic
- phase amphibians. Toxicity to Aquatic Animals Freshwater Fish, Acute ( OPPTS 850.1075 Freshwater Fish Acute) Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity of flutriafol to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish (a warmwater fish). Results are tabulated below (Table F 1). Table F 1 . Freshwater Fish Acute Toxicity with Flutriafol 1 Species % ai 96 - hour LC 50 (m g ai/L) Toxicity

Category * New/(old) MRID No.

Author/Year Study

Classification Rainbow trout (Oncorhynchus mykiss) 93.0 52.3 A Slightly toxic 47090311 / (163466) Hill, R.W. (1982) Acceptable Bluegill sunfish (Lepomis macrochirus) 93.0 33 B Slightly toxic 47090310 / (163467) Hill, R.W. (1985) Acceptable

* Toxicity Category for Fish and Invertebrates : <0.1 = very highly toxic , 0.1

– 1 = highly toxic , >1
- 10 = moderately toxic , >10

- 100 = slightly toxic , >100 = practically non
- toxic A Trout 95% Confidence Interval (C.I.) = 45.3
- 58.9 mg ai/L (binomial method); Probit slope = 3.89
. B Sunfish 95% C.I. = 23

– 44 mg ai/L; Probit slope = 4.04 1 values in bold are selected for the flutriafol risk assessment. The 96
- hr LC 50 s of flutriafol to freshwater fish range 33

– 52.3 mg ai/L , which fall in the toxicity category as slightl y toxic to freshwater fish on an acute exposure basis. The upgraded studies are scientifically

sound and fulfill the OPPTS 850.1075 guideline requirement for acute toxicity to freshwater fish. MRID: 47090311 In a 96
- h acute toxici ty

study , r ainbow trout ( Oncorhynchus mykiss ) were exposed to PP450 ( f lutriafol) at nominal concentrations of 0 (negative and solvent controls), 10.0, 18.0, 32.0, 56.0, 75.0 and 100.0 mg ai/Lunder flow
- through conditions. The reviewer
- calculated time
- weighted average (TWA) concentrations were <0.50 (<LOQ; controls), 7.9, 14.3, 26.1, 45.3, 58.9 and 111.7 mg ai/L. The TWA L C 50 and NOAEC for mortality were 52.3 and 45.3 mg ai/L, respectivel y. The TWA EC 50 and NOAEC values, based on sub
- lethal effects, were 17.3 and 7.9 mg ai/L, respectivel y. Sub
- lethal effects (i.e., dark discoloration, loss of equilibrium, quiescence,176

labored and/or rapid respiration, swelling of the gut, and coughing) were observed in the groups exposed to 14.3
- 111.7 mg ai/L of PP450. MRID: 47090310 In a 96
- h acute toxicity

study , b luegill s unfish (

Lepomis macrochirus ) were exposed to f lutriafol at nominal concentrations of 0 (negative and solvent controls), 18, 32, 56, 100 and 180 mg ai//L under static conditions; mean
- measured concentrations were <1.8 (<LOQ; controls), 18, 32, 55, 103 and 172 mg ai/L . The 96
- h LC 50 was 33 mg ai/L . The NOAEC value, based on mortality and sub
- lethal effects, was <18 mg ai/L ; an EC 50 value could not be determined. Sub
- lethal effects (hyperactivity, spiraling, loss of balance, coughing and rapid and labored respiration) were reported; however , the study author did not specify

the treatment levels that exhibited these effects. Addition al Freshwater Fish Acute Studies Tested with Formulation Product of Flutriafol Additional freshwater fish toxicity studies with rainbow trout and bluegill sunfish were also submitted by

the registrant on the flutriafol formulation product, Flutriafol 125 g/l SC. Results are tabulated below (Table F 1a). Table F 1a. Freshwater Fish Acute Toxicity with Flutriafol 125 g/l SC (Form ulation Product) Species % a i 96 - hour LC 50 (m g form/L) MRID No.

Author/Year Study

Classification Rainbow trout (Oncorhynchus mykiss) 11.6 7.9 47090312 Sankey (1993) Acceptable Bluegill sunfish (Lepomis macrochirus) 11.9 20 47090309 Palmer, Sutherland, and Kendall (2007) Accepta ble Form

– formulation product The 96
- hr LC 50 s range 7.9

– 20 mg form/L. The studies suggest the high toxicity of flutriafol in the formulation end use product to fish is primarily due to the toxicity of inerts in the formulation , not the active ingredi ent. The studies are scientificall y sound and fulfill the OPPTS 850.1075 guideline requirement for acute toxicity to freshwater fish. MRID: 47090309 In a 96
- h acute toxicity

study , bluegill sunfish (

Lepomis macrochirus ) were exposed to Flutriafol 125 g/L SC (formulation co ntaining the active ingredient f lutriafol) at nominal concentrations of 0 (negative control), 4.7, 7.8, 13, 22, and 36 mg formulation/L . The nominal concentrations based on f

lutriafol were 0 (negative control), 0.56, 0.93, 1.5, 2.6 and 4 .3 mg ai/L under static conditions. The author calculated mean
- measured concentrations of F lutriafol 125 g/L SC were <0.2 (LOQ; control), 4.8, 7.8, 13, 22, and 35 mg formulation/L . The reviewer calculated time
weighted average (TWA) concentrations of flutriafol were <0.200 (<LOQ; controls), 0.568, 0.930, 1.54, 2.59 and 4.22 mg ai/L. The 96
- h L C 50 and NOAEC for mortality were 2.3 and 1.54 mg ai/L, respectivel y. At test termination, the EC 50 and NOAEC values, based on sub
- lethal effects, was >2.59 and 2.59 mg ai/L, respectivel y. It is worthy to note that at 24 hours, sub
- lethal177

effects (surfacing, loss of equilibrium, and lying on bottom of vessel) were observed in the groups exposed to 1.54 and 2.59 mg ai/L. MRID: 47090312 In a 96
- h acute toxicity

stu dy , rainbow trout ( Oncorhynchus mykiss ) were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient f lutriafol) at nominal concentrations of 0 (negative control), 0.75, 1.5, 3.0, 6.0, 12 and 24 mg form/L under flow through conditio ns. The mean - measured concentration of Flutriafol 125 g/L SC were <0.1 (<LOQ; control), 0.63, 1.4, 2.7, 5.6, 11 and 23 mg form/L . The reviewer
- calculated time
- weighted average concentrations (TWA) of the active ingredient were <0.01 (<LOQ; control), 0.073 , 0.16, 0.31, 0.65, 1.28, and 2.67 mg ai/L. The 96
- h LC 50 and NOAEC for mortality were 0.9 and 0.67 mg ai/L, respectivel y. Sub
- lethal effects (e.g., quiescence, sounding, ceased swimming, loss of balance, dark discoloration and irregular respiration) were observed in the 3 highest treatment levels exposed to f lutriafol 125 g/L SC; however, complete mortality was observed at the highest level prior to the first observation at 24 hours. Freshwater Fish, Chronic ( OPPTS 850.1400 Freshwater Fish Early Life Stage) A freshwater fish earl y life
- stage test using the TGAI is required for flutriafol because the end
use product may

be applied directl y to water or is expected to be transported to water from the intended use site
. The preferred test species is fath ead minnow . Results of this test are tabulated below (Table F 2)
. Table F 2. Freshwater Fish Early Life - Stage Toxicity with Flutriafol Under Flow - through Conditions Species % ai NO AEC (m g ai/L ) LOAEC

( mgai/L ) Endpoints

Affected MRID No.

Author/Year Study

Classification Fathead minnow (Pimephales promelas ) 95.1 4.8 9.5 post - hatch survival (most sensitive), post - hatch clinical signs of toxicity, and growth 47090317

Palmer, Kendall, and Krueger (2007) Acceptable Flutriafol caused significant reductio ns in post
- hatch survival of rainbow trout at concentrations of 9.5 mg ai/Land higher establishing a NOAEC of 4.8 mg ai/L . This study is scientifically sound and fulfills the OPPTS 850.1400 guideline requirement for chronic toxicity to freshwater fish. MRID: 47090317 No treatment
- related effects on time to hatch or hatching success were observed. Hatching occurred between day s 3 to 6 at all levels, and hatching success averaged 99 and 91% in the negative and solvent control groups, respectively , compare d to 88, 95, 100, 98, and 90% in the mean - measured 1.2, 2.4, 4.8, 9.5, and 19 mg ai/Ltreatment levels, respectively . The slightl y lower hatching success in the 1.2 and 19 mg ai/Ltreatment groups was primarily due to embryos that died from fungal infecti on on Day 5 (7 and 4 embryos, respectivel y). During the post
- hatch period, a treatment
- related increase in the incidences of clinical signs of toxicity (organisms that were small, weak, or had curved spines) was observed at the two178

highest
- dosage treatment levels (9.5 and 19 mg ai/L) . Furthermore, a treatment
- related effect on post - hatch larval survival was observed at these levels. On Day 33 (study termination), larval survival averaged 94 and 96% in the negative and solvent control groups, respectivel y, compared to 87, 96, 89, 71, and 44% in the mean
- measured 1.2, 2.4, 4.8, 9.5, and 19 mg ai/L treatment groups, respectively
. T reatment - related effects on terminal growth (total length, wet weight, and dry weight) were observed at the highest
- dosage treatment level (19 mg ai/L)
. Freshwater Invertebrates, Acute ( OPPTS 850.1010 Freshwater Invertebrate Acute) A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of flutriafol to aquatic invertebrates. The p referred test species is Daphnia magna . The results are tabulated below (Table F 3 )
.

Table F 3 . Freshwater Invertebrate Acute Toxicity with Flutriafol * Species % ai 48 - hour EC 50 (m g ai/L) Toxicity

Category New / (old)

MRID No. Author/Year Study

Class ification

Water flea (Daphnia magna) 93.0 >63.5 (Test I) Slightly toxic 47090304 / (163468) Hamer and Hill (1982) acceptable 93.0 67 (Test II) Slightly toxic 47090304 / (163468) Hamer and Hill (1982) acceptable Water flea (Test I) EC 50 = 90 mg ai/L; 95% Confidence Interval = 69
- 538 mg ai/L ; Probit slope = Not reported. Water flea (Test II) 95% Confidence Interval = 59 - 78 mg ai/L; Probit slope = 5.43. * Value s in bold are selected for the flutriafol risk assessment. The 48
- hr EC 50 s for water flea exposed to flutriafol technical that range 67
- 90 mg ai/L classifies the test material as slightly to practicall y nontoxic to the freshwater invertebrates on an acute exposure basis. The study is scientifically

sound and fulfills the OPPTS 850.1010 guidel ine requirement for acute toxicity to freshwater invertebrates. MRID: 47090304 The 48
- hour acute toxicity of PP450 ( f

lutriafol) to Daphnia magna was studied twice under static conditions. During the first exposure, daphnids were exposed to nominal concentrations of 0 (negative control), 1, 2, 4, 8, 16, 32 and 64 mg ai/Lfor 48 hours; mean
- measured concentrations were <0.02 (<LOQ; control), 1.0, 1.9, 3.9, 8.1, 15.9, 30.3 and 63.5 mg ai/L. During the second exposure, daphnids were exposed to nominal concentrations of 0 (negative control), 2, 4, 8, 16, 32, 64 and 100 mg ai/Lfor 48 hours; mean
- measured concentrations were <0.3 (<LOQ; control), 1.7, 3.8, 7.7, 15.5, 32.6, 59.5 and 90.1 mg ai/L . Immobilization and dead daphnids were observed after 4, 10, 24 and 48 hours in both tests. The 48
- hour EC 50 value from the first test was >63.5 mg ai/L. The 48
- hour EC 50 value from the second test was 67.1 mg ai/L
. No sub
- lethal observations were made. The 48
- hr NOAEC based on immobility and dead daphnids were 15.9 mgai/Lfrom the first test and 15.5 mg ai/L from the second test. Additional Fresh water Invertebrate Acute Study with Formulation Product of Flutriafol Additional freshwater invertebrate toxicity study with the water flea was also submitted by the re gistrant on the flutriafol formulation product, Flutriafol 125 g/l SC. Results are tabulated179

below (Table F 3 a).

Table F 3a . Freshwater Invertebrate Acute Toxicity with Flutriafol 125 g/l SC Species % ai 48 - hour EC 50 (m g form/L) Toxicity

Category MRID No.

Author/Year Study

Classification Water flea (Daphnia magna) 11.77 7.05 N/A 47090305 Kent, S. (1994) Acceptable Form

– formulation product The 48
- hour EC 50 value is 7.05 mg ai/L
. The study suggest s the high toxicity of flutriafol in the formulation product to daphnids is primarily due to the toxicity

of inerts in the formulation , not the active ingredient. This study with the formulation product of flutriafol is scientifically sound and fulfills the OPPTS 850.1010 guideline requirements for acute to xicity to freshwater invertebrates. MRID: 47090305 The 48
- hour acute toxicity of f lutriafol (125 g/L SC Formulation) to Daphnia magna was studied under static conditions. Daphnids were exposed to nominal concentrations of 0 (negative control), 1.8, 3.2, 5.6, 10, 18 and 32 mg formulation/Lfor 48 hr; the nominal concentrations based on f

lutriafol were 0 (negative control), 0.21, 0.38, 0.66, 1.2, 2.1 and 3.8 mg ai/L. Mean
measured concentrations were <0.013 (<LOQ; control), 0.19, 0.35, 0.62, 1.1, 2.1 and 3 .9 mg ai/L . Mortality and immobility were observed daily
. After 48 hours of exposure, immobility was 0% in the negative control and mean
- measured 0.19, 0.35 and 0.62 mg ai/Ltreatment groups. Complete immobility and dead daphnids were observed in the me an - measured 1.1, 2.1 and 3.9 mg ai/Ltreatment groups. The 48
- hour EC 50 and 95% C.I . w as 0.83 (0.62
- 1.1) mg ai/L. The 48
- hr NOAEC based on immobility was 0.62 mg ai/L. No sub
- lethal effects observations were made. Freshwater Invertebrate, Chronic ( OPPT S 850.1300 Freshwater Invertebrate Life Cycle) A freshwater aquatic invertebrate life
- cycle test using the TGAI is required for flutriafol because the active ingredient may be transported to water from the intended use sites and may be persist in the aquatic environment. The preferred test species is the water flea (Daphnia magna)
. Results of this test are tabulated below (Table F 4)
. Table F 4. Freshwater Aquatic Invertebrate Life - Cycle Toxicity with Flutriafol TGAI* Species % ai NOAEC (m g ai/L) LOAEC

( mgai/L) Endpoint

Affected MRID No.

(Author/Year) Study

Classification

Water flea (Daphnia m agna) 95.5 0.31 0.55 Gro wth (length) 47090314 Williams, Stewart, and Tapp (1990) Acceptable

95.5 1.0 3.2 Reproduction (most sensitive) and survival 47090315

B atscher, R. (2004) Supplemental 1180

Table F 4. Freshwater Aquatic Invertebrate Life - Cycle Toxicity with Flutriafol TGAI* * Values in bold are selected for the flutriafol risk assessment. 1 Only the test solutions of the biologically relevant levels were analyzed in this study. Guideline requires all treatment levels including the biologically relevant levels be analyzed. Results indicate flutriafol caused significant reductions of growth at 0.55 mg ai/L and of reproduction at 3.2 mg ai/Lto Daphnia magna establishing a NOAEC of 0.31 mg ai/L. The studies are both scientifically sound; howe ver, the latter study (MRID 47090315) does not fulfill the OPPTS 850.1300 guideline requirement for chronic toxicity to freshwater invertebrates. MRID: 47090314 The 21
- day
- chronic toxicity of flutriafol to Daphnia magna was studied under static renewal c onditions. Daphnids were exposed to flutriafol at nominal concentrations of 0 (negative control), 0.32, 0.56, 1.0, 1.8, 3.2, and 5.6 mg/L. Mean
- measured concentrations were <0.03
- <0.19 (<LOD, control), 0.31, 0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L, respectively . The mean
measured values are reported since the reviewer’s calculated time
- weighted average (TWA) values were identical to the study author’s mean
- measured concentrations. The 21
- day NOAEC and LOAEC, based on terminal length measurements (the most sensitive endpoint), was 0.31 and 0.55 mg ai/L, respectively. No first
- generation mortality occurred at any test level during the 21
- day study . The time to first brood release was not assessed as a toxicological endpoint and raw data were not provided. It was reported that all first
- generation daphnia from the control, 0.31, and 0.55 mg ai/Ltreatment levels released the first offspring by Day 9, and completed five broods of offspring. The total number of young produced (live and dead) per first
- generati on daphnid averaged 164 for the control group, compared to 164, 159, 123, 19, 0, and 0 for the 0.31, 0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L treatment groups, respectivel y. Differences were statistically
- reduced compared to the control (p=0.05) at the ≥0.97 mg ai/Llevels. Of the total number of offspring produced, 7% were dead on removal from the 1.8 mg ai/Ltreatment level. In addition, aborted broods were observed at the 1.8, 3.2, and 5.6 mg ai/Ltreatment levels beginning on Day

8. The lengths of surviving daphnids after 21 day s averaged 4.53, 4.49, 4.37, 4.34, 4.39, 4.17, and 4.22 mm for the control, 0.31, 0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L treatment levels, respectively . Differen ces were statistically
- reduced compared to the control (p=0.05) at the ≥0.55 mg ai/Llevels. MRID: 47090315 The 21
- day
- chronic toxicity of flutriafol to Daphnia magna was studied under static renewal conditions. Daphnids were exposed to flutriafol at nom inal concentrations of 0 (negative control), 0.10, 0.32, 1.0, 3.2, and 10 mg ai/L . Recoveries of select test solutions indicated that flutriafol was stable under the conditions of the study . Mean
- measured concentrations of the select test solutions were 0 (LOQ not reported; negative control), 1.02 and 3.2 mg ai/L which were identical to the nominal concentrations of 1.0 and 3.2 mg/L. The 21
- day NOAEC and LOAEC, based on complete inhibition of reproduction at the 3.2 mg ai/L level (the most sensitive endpo int), were 1.0 and 3.2 mg ai/L , respectivel y. Survival ranged from 90
- 100% at the control through 3.2 mg ai/Llevels, and was 0% at the 10 mg ai/L level, where all animals had died by Day 5. The time to first brood release was not assessed as a toxicologi cal endpoint during the study. It was reported that all first
- generation da phnia from the ≤0.32 mg ai/L treatment levels released the first offspring b y Day 9 (Friday). At the 1.0 mg ai/L level, the first181

offspring were recorded on Day 12 (Monday , the next observation interval), and it was noted that the total number of offspring produced at this level through Day 14 exceeded the number produced at the ≤0.32 mg ai/L treatment levels. Reproduction was completely inhibited at the 3.2 mg ai/L treatment level. The number of live offspring produced per surviving adult was 81.4 for the control group, and 79.1, 77.6, 75.5, and 0.0 for the 0.10, 0.32, 1.0, and 3.2 mg ai/L treatment groups, respectively . The difference was statistically significant (α=0.05) at the 3.2 mg ai/Llevel. No treatment
- related effect on the lengths of surviving first
- generation daphnids was observed. After 21 day s, lengths averaged 3.89
- 3.99 mm for all levels. In addition, no visible abnormalities (excluding mortality and reduced reproduction rate) were observed in any animal during the test. Additional Freshwater Invertebrate Life - Cycle Study with Formulation Product of Flutriafol Additional freshwater invertebrate life
- cycle study with the water flea was also submitted by the registrant on the flutriafol end use product, Flutriafol 125 g/l SC. Results are tabulated below (Table F 4 a). Table F 4a. Freshwater Aquatic Invertebrate Life - Cycle Toxicity with Flutriafol 125 g/L SC (CHA 1310 - 03) Species % ai NOAEC (m g form/L) LOAEC

( mg form/L) Endpoint

Affected MRID No.

(Author/Year) Study

Classification W ater flea (Daphnia magna ) 12.5 0.10 0.32 Survival and reproduction (most sensitive) 47090316

Batscher, R. (2004) Supplemental 1

1 Only the test solutions of the biologically relevant levels were analyzed in this study. Guideline requires all treatment levels including the biologically relevant levels be analyzed. Results indicate Flutriafol 125 g/l SC caused significant reductions of reproduction at 0.04 mg ai/Lto Daphnia magna establishing a NOAEC of 0.013 mg ai/L. The study suggest s the high toxici ty of flutriafol in the formulation product to daphnids is primarily due to the toxicity

of inerts in the formulation , not the active ingredient. This study is scientifically

sound but does not fulfill the OPPTS 850.1300 guideline requirements for chronic toxicity to freshwater invertebrates. MRID: 47090316 The 21
- day

life
- cycle toxicity

of CHA 1310
- 03 (a soluble concentration formulation containing 12.5% flutriafol) to Daphnia magna was studied under static renewal conditions. Daphnids were exposed to the test material at nominal concentrations of 0 (negative control), 0.032, 0.1, 0.32, 1.0, and 3.2 mg product/L. The reviewer
- calculated nominal concentrations based on f lutriafol were 0 (negative control), 0.004, 0.013, 0.04, 0.13, and 0.4 mg ai/L . Reco veries of select test solutions indicated that flutriafol was stable under the conditions of the study . Mean
- measured concentrations of the select test solutions were 0 (LOQ not reported; negative control), 0.096 and 0.32 mg form/L (0.012 and 0.04 mg ai/L) which were identical to the nominal concentrations of 0.1 and 0.32 mg form/L(0.0125 and 0.04 mg ai/L). The 21
- day NOAEC and L OAEC, based on offspring per parent (reproduction) at the ≥0.04 mg ai/L levels (the most sensitiv e endpoint), were 0.096 and 0.32 mgform/L(0.012 and 0.04 mg ai/L), respectively . Survival was 100% at182

the control through 0.13 mg ai/L levels, and 80% at the 0.4 mg ai/Llevel. The time to first brood release w as not assessed as a toxicological endpoint during the study . It was reported that all first
- generation daphnia from the ≤0.13 mg ai/L treatment levels released the first offspring b y Day 9 (Friday). At the 0.4 mg ai/L level, the first offspring were rec orded on Day 12 (Monday , the next observation interval). Reproduction was inhibited at the ≥0.04 mg ai/Ltreatment levels. The number of live offspring produced per surviving adult was 68.3 for the control group, and 66.0, 63.6, 60.8, 58.6, and 51.1 for the 0.032, 0.1, 0.32, 1.0, and 3.2 mg form/Ltreatment groups, respectivel y. The differences were statisticall y significant (α=0.05) at the 0.32, 1.0, and 3.2 mg form/Llevels. At the 1.0 and 3.2 mg form/Ltreatment levels, dead offspring were observed, mainly in the first brood. No treatment
- related effect on the lengths of surviving first
- generation daphnids was observed. After 21 day s, lengths averaged 3.81
- 3.97 mm for all levels. In addition, no visible abnormalities (excluding mortality , reduced reproduction rate, and dead offspring) were observed in any animal during the test. Estuarine/Marine Fish, Acute ( OPPTS 850.1075 Estuarine/Marine Fish Acute) Acute toxicity

testing with estuarine/marine fish using the TGAI is required for flutriafol be cause the end
- use product is intended for direct application to the marine/estuarine environment or the active ingredient is expected to reach this environment because of its use in coastal counties. The preferred test species is sheepshead minnow. Results are tabulated below (Table F 5). Table F 5. Estuarine/Marine Fish Acute Toxicity with Flutriafol TGAI Species % ai 96 - h LC 50 (m g ai/L) Toxicity

Category MRID No.

(Author/Year) Study Classification Sheepshead minnow (Cyprinodon variegatus) 95.1 >72.2 A No more than slightly toxic 47090308

Palmer, Sutherland, Kendall, et al (2007) Acceptable
A a probit slope along with 95% confidence intervals could not be calculated due to lack of a concentration
- response relationship. The 96
- hour L C 50 value of >72.2 mg ai/Lclassifies flutriafol as no more than slightly toxic to Cyprinodon variegates on an acute exposure basis. This study is scientifically

sound and fulfills the OPPTS 850.1075 guideline requirements for acute toxicity to estuarine/marine fish. MRID: 47090308 In a 96
- h acute toxicity

study , sheepshead minnow ( Cyprinodon variegatus ) was exposed to f lutriafol technical at nominal concentrations of 0 (negative control), 18, 27, 42, 65 and 100 mg ai/Lunder static conditions. The reviewer
- calculated TWA concentrations were <4.00 (LOQ; control), 13.8, 22.2, 34.2, 51.9 and 72.2 mg ai/L
. By test termination, mortality was 45% at the 72 mg ai/L treatment group. The 96
- h LC 50 was >72.2 mg ai/L. The EC 50 and NOAEC values, based on sub
- lethal effects, were 27 .6 and 13.8 mg ai/L, respectivel y. Sub
- lethal effects (lethargy , surfacing, loss of equilibrium and erratic swimming) were observed in the groups exposed to TWA concentrations of 22.2, 34.2, 51.9 and 72.2 mg ai/Lof f lutriafol. Estuarine/Marine Fish, Chronic ( OPPTS 850.1400 Estuarine/Marine Fish Life - Cycle) An estuarine/marine fish life
- cycle toxicity test was not available for flutriafol.183

Estuarine/Marine Invertebrates, Acute ( OPPTS 850.1025 and 850.1035 Estuarine/Marine Invertebrate Acute) Acute toxicity

testing with estuarine/marine invertebrates using the TGAI is required for flutriafol because the end
- use product is intended for direct application to the marine/estuarine environment or the active ingredient is expected to reach this environment because of its use in coastal counties. The preferred test species are mysid shrimp and eastern o yster. Table F 6. Estuarine/Marine Invertebrate Acute Toxicity with Flutriafol TGAI* Species % ai. 96 - h EC 50/ LC 50 (m g ai/L) Toxicity

Category MRID No .

(Author/Year) Study

Classification Mysid shrimp (Americamysis bahia) 95.1 34.9 Slightly toxic 47090307

Palmer, Sutherland, Kendall, et al (2007) Acceptable Eastern oyster (Crassostrea virginia) shell deposition 95.1 25 Slightly toxic 47090306

Palmer, S utherland, Kendall, et al (2007) Acceptable Shrimp 95% Confidence Intervals: 30.8
- 47.2 mg ai/L; Probit slope = 7.43 Oyster 95% Confidence Intervals: 17

– 38 mg ai/L; Probit slope = 2.14 ± 0.864 * Values in bold are selected for the flutriafol risk assessm ent. Since the shrimp L C 50 and oy ster EC 50 fall in the range of 10

– 100 mg ai/L toxicity category , flutriafol is categorized as slightly toxic to estuarine/marine invertebrates on an acute exposure basis. The studies are scientifically sound and fulfil l the OPPTS 850.1025 and 850.1035 guideline requirements for acute toxicity to estuarine/marine invertebrates. MRID: 47090306 The 96
- hour acute toxicity of f lutriafol technical to Crassostrea virginica was studied under flow
- through conditions. Oy sters w ere exposed to nominal concentrations of 0 (negative and solvent controls), 3.2, 5.4, 9.0, 15 and 25 mg ai/L . Time
- Weighted Average (TWA) concentrations were <1.0 (<LOQ; control), 3.23, 5.51, 9.03, 14.6, and 24.2 mg ai/L. Mortality and shell deposition w ere observed dail y. There was no mortality in this study , while inhibition of shell growth in the 3.23, 5.51, 9.03, 14.6, and 24.2 mg ai/L TWA treatment groups was
- 9.3, 4.7, 20.9, 20.9, 23.3, and 53.5%, respectively . The reviewer
- calculated TWA EC 50 (95% C.I .) was 25 (17
- 38) mg ai/L . The TWA NOAEC based on shell deposition was 3.23 mg ai/L. No sub
- lethal effects observations were made. MRID: 47090307 The 96
- hour acute toxicity of f lutriafol to Americamysis bahia was studied under static conditions. My s ids were exposed to nominal concentrations of 0 (negative control), 9.1, 15, 25, 42, 70 mg ai/L. Time Weighted Average (TWA) concentrations were <4.0 (<LOQ; control), 8.1, 13.1, 20.2, 30.8, and 47.2 mg ai/L. Mortality and sub
- lethal effects were observed dail y. After 96
- hours, mortality

was 10, 10, 5, 10, 30, and 100% in the <4.0, 8.1, 13.1, 20.2, 30.8, and 47.2 mg ai/L treatment groups. The reviewer
- calculated TWA L C 50 and NOAEC were 34.9 (30.8
- 47.2) and 20.2 mg ai/L, respectivel y. Lethargy was observed among several mysids at the mean
-184

measured 31 and 47 mg ai/Ltreatment levels; by test termination, all surviving mys ids at the mean - measured 31 mg ai/Ltreatment group were lethargic. Estuarine/Marine Invertebrate, Chronic ( OPPTS 850.1350 Estuarine/Marine Invertebrate Life - Cycle) An estuarine/marine invertebrate life
- cycle toxicity test was not available for flutriafol. Toxicity to Aquatic Plants Aquatic Plants, Tier II (OPPTS 850.4400 and 850.5400 Vascular and Non -Vascular Plants) Aquatic plant testing is required for any fungicide that has outdoor non
- residential terrestrial uses and that may

move off
- site by runoff (solubility

>10 mg/L in water), and/or by drift (aerial) or that is applied directly

to aquatic use sites (except residential). Normall y, Tier I testing with the TGAI or TEP is conducted on duckweed ( Lemna gibba ), a vascular species, and green algae (Skeletonema costatum ), a nonvascular species. Then, Tier II testing is required if either species in Tier I is inhibited 50% or more, and in cludes Selenastrum capricornutum, Anabaena flos

aquae, and a freshwater diatom. Inthis case, the registrant chose to conduct Tier II testing even though it may

not have been triggered. Results based on the formulation product, Flutriafol 125 g/l SC are ta

bulated below ( Table F 7 ). Table F 7. Toxicity of Flutriafol 125 g/l SC to Non - target Aquatic Plants (Tier II) * Species % ai EC 50 (mg ai/L) NOAEC

(mg ai/L) MRID No.,

Author/Year Study

Classification Vascular Plant Species Vascular Plant
- Duckweed L emna gibba 11.9 0.78 (6.6 mg form/L) 0. 0 1 8 1

(0.15 mg form/L) 47090330

Desjardins, Kendall, and Krueger (2006) Supplemental 2 Non Vascular Plant Species Non
- Vascular Plant
- Marine

diatom Skeletonema costatum 11.9 0.46 mgai/L (3.8 mg form/L) 0.1 mgai/L

(0.84 mg form/L) 47090331

Desjardins, Kendall, and Krueger (2006) Supplemental 2 Non
- Vascular Plant
- Blue
green cyanobacteria Anabaena flos

- aquae 11.9 14 2.9 47090334 Desjardins, Kendall, and Krueger (2006) Supplemental 2 Non
- Vascular Plant
- Green

algae Pesudokirchneriella subcapitata 11.9 0.6 0.24 1 47090333 Desjardins, Kendall, and Krueger (2006) Supplemental 2
Non
- Vascular Plant
Freshwater diatom Navicula pelliculosa 11.9 1.0 0.35 47090332 Desjardins, Kendall, and Krueger (2006) Supplemental 2

* Values i n bold are selected for the flutriafol risk assessment. 1 Significant effects were observed at all levels, a NOAEC could not be established; therefore, the EC 05 was used as a surrogate. 2 Data were not available to establish an EC50 for the formulation inerts.185

The Tier II result with the most sensitive nonvascular plant, S. costatum , indicates that growth inhibition of 5.1
- 96 % was observed at concentrations of 0.093

– 0.71 mg ai/L , respectivel y. The Tier II result indicates the marine diatom EC 50 of 0 .46 mg ai/L is used to assess risk of Flutriafol to non - listed nonvascular aquatic plants. It was determined that the NOAEC of 0.1 mg ai/Lis used to assess risk to listed nonvascular aquatic plants. The duckweed EC 50 of 0.78 mg ai/Lis used to evaluate ri sk to non
- listed vascular aquatic plants; the duckweed EC 05 of 0.018 mg ai/Lis used to evaluate risk to vascular aquatic plants that are endangered. In addition, the study suggest s the high toxicity of flutriafol in the formulation product to vascular and nonvascular aquatic plants is primarily due to the toxicity

of inerts in the formulation , not the active ingredient. MRID: 47090330 In a 7
- day

toxicity study , the freshwater floating aquatic vascular plants duckweed ( Lemna gibba ) were exposed to Flutri afol 125 g/L SC (formulation containing the active ingredient Flutriafol) at nominal concentrations of 0 (negative and formulation blank control), 1.1, 2.5, 5.6, 12, 29, 63 mg formulation/L . Based on the active ingredient of flutriafol, the mean
- measured concentrations are <0.0500 (<LOQ; negative and formulation blank controls), 0.13, 0.30, 0.66, 1.5, 3.4 and 7.6 mg ai/Lunder static conditions. The NOAEC, EC 05 and EC 50 values based on biomass, the most sensitive endpoint, are <1.1, 0.15 and 5.6 mg formul ation/L(<0.13, 0.018 and 0.65 mg ai/L), respectively . The % growth inhibition, based on frond counts, in the treated culture as compared to the control ranged from 7.7
- 88%. In addition, significant reductions of biomass were observed at all treatment leve ls (i.e., NOAEC not available). Necrotic fronds were observed in the negative and formulation blank controls, however, onl y 0.29 and 1.1% of the surviving fronds were necrotic. Less than 1% of fronds were chlorotic in the formulation blank controls. Chlo rotic and necrotic fronds were observed in all treatment groups on Day 7 with the percentage of necrotic fronds increasing with increasing concentration. Dead fronds (1.3%) were observed in the highest treatment group at test termination
. MRID: 47090331 In a 96
- hour acute toxicity study , cultures of the marine diatom Skeletonema costatum (CCMP 1332), were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol) at nominal concentrations of 0 (negative and formulation bla nk controls), 0.78, 1.3, 2.2, 3.6 and 6.0 mg form/L. For flutriafol as the active ingredient, the mean
- measured concentrations are 0 (negative and formulation blank controls), 0.10, 0.17, 0.28, 0.47 and 0.78 mg ai/L under static conditions. The NOAEC and E C 50 values based on biomass (the most sensitive endpoint) were 0.10 and 0.46 mg ai/L , respectively . The % growth inhibition, based on cell density , in the treated algal culture as compared to the control ranged from 6.4 to 96%
. There were no compound
- related phy totoxic effects. MRID: 47090332 In a 96
- hour acute toxicity study , cultures of freshwater diatoms Navicula pelliculosa (UTEX 667), were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol) at nominal concentrations of 0 (negative and formulation blank controls), 1.5, 3.0, 6.0, 12, 25, and 50 mg form/L. For flutriafol as the active ingredient, the mean
- measured concentrations are 0 (negative and formulation blank controls), 0.17, 0.35, 0.70, 1.4, 2.9 and 5.9 mg ai/L under static conditions. The NOAEC and EC 50 values based on biomass, the most186

sensitive endpoint, were 0.35 and 1.0 mg ai/L , respectivel y. The % growth inhibition, based on cell density , in the treated algal culture as compared to the control ranged from
- 5.1 to 98%. There were no compound
- related phyt otoxic effects. MRID: 47090333 In a 96
- hour toxicity

study , cultures of freshwater green algae Pseudokirchneriella subcapitata (UTCC 37), were exposed to Flutriafol 125 g/LSC (formulation co ntaining the active ingredient f lutriafol) at nominal concentration of 0 (negative and formulation blank controls), 1.6, 2.6, 4.3, 7.2, 12, and 20 mg form/L. The mean
- measured concentrations of the active ingredient, flutriafol, are 0 (negative and formulation blank controls), 0.19, 0.32, 0.52, 0.89, 1.5 and 2.4 mg ai/Lunder static conditions. The NOAEC, EC 05 and EC 50 values based on biomass, the most sensitive endpoint, were <0.19, 0.24 and 0.60 mg ai/L , respectivel y. The % growth inhibition, based on cell density, in the treated algal culture as compared to the control ranged from 14 to 100%. There were no compound
- related phyt otoxic effects. MRID: 47090334 In a 96
- hour toxicity

study , cultures of freshwater blue
- green algae (C yanobacteria), Anabaena flos

- aqua e (UTCC 67), were exposed to Flutriafol 125 g/L SC (formulation co ntaining the active ingredient f

utriafol) at nominal concentrations of 0 (negative and formulation blank controls), 2.2, 4.9, 11, 24, 54, and 120 mg form/L. The mean
- measured concentrations of flutriafol are 0 (negative and formulation blank controls), 0.26, 0.58, 1.3, 2.9, 6.4 and 14 mg ai/L under static conditions. The NOAEC and EC 50 values based on cell density and biomass, the most sensitive endpoints, were 2.9 and 14 mg ai/L. The % growth inhibition, based on cell density, in the treated algal culture as compared to the control ranged from
- 17 to 44%. There were no compound
- related phy

totoxic effects. Toxicity to Terrestrial Animals Birds, Acute and Subacute ( OPPTS 850.2100 Avian Acut e Oral) An acute oral toxicity

study using the technical grade of the active ingredient (TGAI) is required to establish the toxicity

of flutriafol to birds. The preferred test species is either mallard duck (a waterfowl) or bobwhite quail (an upland game bird) and a passerine bird . Results of avian acute oral toxicity

studies are tabulated below (Table F 8 )
.187 Table F 8 . Avian Acute Oral Toxicity with Flutriafol TGAI Species % ai LD 50 (mg ai/kg bw) Toxicity

Category * New / (old) MRID No.

Author/Year Study Classification Red
- Legged partridge ( Alectoris rufa ) 93 616 A Slightly toxic 47090319

Roberts and Fairley (1982) Supplemental B Northern bobwhite quail (Colinus virginianus) 95.1 810 Slightly toxic 47471301

Hubbard and Beavers (2008) Acceptable
Mallard duck ( Anas platyrhynchos ) 93.0 > 5000 C Practically nontoxic 47090318 / (163464)

Roberts and Fairley (198 2) Acceptable

* Toxicity Category for Birds and Mammals via Oral Route : <10 = very highly toxic , 10
- 50 = highly toxic , 51
- 500 = mo derately toxi c , 501
- 2000 = slightly toxic , >2000 = practically non
- toxic
A Partridge 95% Confidence Intervals = 342

– 1108 mg ai/kg bw; Probit slope = N/A (binomial test). B >5% mortality occurred during acclimation C a probit slope along with 95% confidence intervals could not be calculated due to lack of a concentration
- response relationship. Because the non
- passerine LD 50 falls between 501 and >2000 mg ai/kg
- bw, flutriafol TGAI is categorized as slightly

to practicall y non - toxic to birds on an acute oral bas is. Data with a passerine bird is not available, thus, the guideline (OPPTS 850.2100) is not fulfilled. Red
- legged partridge (MRID 47090319) In summary , cumulative mortality in partridges were 0% (control), 0, 0, 50, 100, and 100% at the 0, 190, 342, 61 6, 1108, and 1995 mg ai/kg bw treatment levels, respectively. All deaths occurred on Day 1
- 6. Clinical signs of toxicity of subdued behavior, unsteadiness, weakness, and squatting and/or prostration were observed in the three highest levels. Treatment
- related effects of reduced food consumption was observed in the 342 and 616 mg ai/kg bw for females. No treatment - related effects on body weight gains or upon necrops y were observed. Mallard duck (MRID 47090318) In summary , of the 1069, 1572, 2312, 3400, and 5000 mg ai/kg
- bw treatment groups, there were no treatment - related effects or signs of toxicity observed in control and the three lowest
- dosage groups. At test termination, three birds in the 3400 mg/kg group and three birds in the 5000 mg/kg group were d ead. Signs of toxicity observed in the dead birds were unsteadiness or unable to stand. No other abnormalities were observed and all surviving birds were in good health. Over day 0 to 3, mean body

weight decreases were observed in all groups with control b irds showing a mean body weight increase. Group mean body weight changes were within normal limits after day 3. Reduced food consumption was observed in the two highest
- dosage groups. A post
mortem examination of the birds revealed pale livers, fluid in th e body cavity , intestines stained red, pale kidney s, hard white lump in body cavity, and white nodule or spots on livers. Birds, Subacute ( OPPTS 850.2200 Avian Subacute Dietary)188

Two subacute dietary

studies using the TGAI are required to establish the subacute toxicity of flutriafol to birds. The preferred test species are mallard duck and bobwhite quail. Results of the tests are tabulated below (Table F 9 )
.

Table F 9 . Avian Subacute Dietary Toxicity with Flutriafol TGAI Species % ai 8 - Day LC 50 (mg ai/kg - diet) Toxicity

Category New / (old)

MRID No. Author/Year Study

Classification Northern bobwhite quail (Colinus virginianus) 93.0 6532 A Practically nontoxic 47090321 /

(163680) Roberts, N.L. and et al (1986) acceptable

Mallard duck ( Anas platyrhynchos ) 93.0 4062 B Slightly toxic 47090320 / (163465) Roberts, Fairley, and Al mond (1982) acceptable

* Toxicity Category for Birds and Mammals via Dietary Route : <50 = very highly toxic , 50

– 500 = highly toxic , 501
- 1000 = moderately toxic , 1001
- 5000 = sl ightly toxic , >5000 = practically non
- toxic
A Quail 95% Confidence Interval = 5240
- 7700 mg ai/kg
- diet ; Probit slope = N/A (binomial test). B Duck 95% CI = 2985
- 5521 mg ai/kg
- diet (moving average) ; Probit slope = 2.7. Because the LC 50 falls between 100 1 and >5000 mg ai/kg
- bw, flutriafol is categorized as slightl y to practicall y non - toxic to birds on a subacute dietary basis. The guideline (OPPTS 850.2200) is fulfilled. Cumulative mortality

in mallard ducks (MRID 47090320) was 0% (control), 10, 10, 30, 80, 70, 100, and 90% in the <LOQ, 1136, 1832, 2955, 4767, 7688, 12400, and 20000 mg ai/kg
- diet treatment groups, respectively . All mortality occurred on Day

3
- 7. Unsteadiness was observed in two highest levels. Treatment
- related effects on body weight an d food consumption were observed at all levels; the effects increased with increasing concentration. Necrops y revealed pale or blotchy livers. Cumulative mortality

in bobwhite quails (MRID 47090321) was 0% (control), 0, 0, 0, 0, 100, and 100% in the <LOQ, 594, 1100, 2180, 5240, 7700, and 10700 mg ai/kg
- diet, respectively . All mortality occurred on Day

1

– 4. Subdued behavior and/or unsteadiness were observed in the three highest levels. A treatment
- related effect on food consumption was observed in the four highest levels. No treatment
- related effects on body weight or upon necropsy were observed. Birds, Chronic (OPPTS 850.2300 Avian Reproduction) Two avian reproduction studies using the TGAI in the diet are required to establish the chronic toxicity of f lutriafol to birds. The preferred test species are mallard duck and bobwhite quail. Results of the tests are tabulated below (Table F 10 )
.189

The data that were submitted show the reproduction NOAEC for duck and quail to be 39.2 an d <95.0 mg ai/kg diet, respectivel y. Results indicate the mallard duck is plausibly more sensitive to flutriafol than the bobwhite quail; therefore, the duck NOAEC value of 39.2 mg ai/kg
- diet is used to evaluate potential chronic effects to birds
. The gui deline (OPPTS 850.2300) is fulfilled. The duck study (MRID 47090322) is classified as acceptable while the quail study (MRID 47090323) is considered supplemental in the absence of an NOAEC as a result of significant effects at all test levels
. MRID: 47090 322 The one
- generation reproductive toxicity of flutriafol to 16 pairs per level of 18
- week old mallard duck (

Anas platyrhynchos ) was assessed over approximately 21 weeks. Flutriafol was administered to the birds in the diet at nominal concentrations of 0 (negative control), 40, 100, 300, and 1000 mg ai/kg dw diet. Mean
- measured concentrations were <20 (<LOD, control), 39.2, 97.5, 315, and 1070 mg ai/kg diet, respectively . The estimated daily dietary dose was 0.0, 6.0, 13.1, 39.4, and 163.8 mg ai/kg bw/day , respectively . There was no treatment
- related mortality or clinical signs of toxicity noted at any

treatment level. However, effects on food consumption and female body weights were observed at the 1070 mg ai/kg diet level. Mean feed consumption was significantly
- increased at the 1070 mg ai/kg diet group compared to the control group during weeks 5 through 9 (153 to 209 g/bird/day compared to 80 to 131 g/bird/day for the control group). Overall, feed consumption averaged 161, 180, 154, 157, and 186 g/bird/day for the control, 39.2, 97.5, 315, and 1070 mg ai/kg diet levels, respectivel y. The body weight of females from the 1070 mg ai/kg diet level was statistically
- reduced compared to the control during Weeks 4 (p<0.05; 1040 versus 1138 g, respective ly) and 21 (p<0.01, 1057 versus 1206 g, Table F 10 . Chronic Toxicity of Flutriafol TGAI to Bobwhite Quail and Mallard Ducks. Species %

a.i. NOAEC (m g/kg - diet) LOAEC

(m g/kg - diet) Most Affected

E ndpoints MRID no.

Author/Year Study C lassification Northern bobwhite quail (Colinus virginianus) 94.4 <95 95 % survivors of eggs set and 14
- day old survivors’ body weights 47090323

Thompson, H. (2007) Supp lemental 1

Mallard duck ( Anas platyrhynchos ) 95.1 39.2 97.5 Reproduction (percentage of hatchlings of live 3
- week embryos, percentage of hatchling of eggs set, 14
- day survivors, and number of hatchling) 47090322

Temple, Frey, Beavers, et al (2007) Accepta ble

1 Significant effects were observed at all treatment levels, a NOAEC could not be determined. The study needs to establish an N OAEC with lower concentrations.190

respectivel y). Overall, the 1070 mg ai/kg diet group females had a reduction in mean body weight (
- 47 g) while the females in all the other groups had an increase in mean body weight (88 to 143 g). Gross necropsy at study termination indicated increased incidences of small testes in the males and regressed ovaries in the females from the 1070 mg ai/kg diet level that were considered related to treatment. Treatment
- related effects upon reproduction were observed at all test concentrations. At the 39.2 and 97.5 mg ai/kg diet levels, there were apparent treatment
related effects upon hatchability (no. of hatchlings relative to no. of live 3
- week embryos), although the differences were not statisticall y- significant and not clearl y dose
- related. Hatchability

was 63 and 65% for the 39.2 and 97.5 mg ai/kg diet levels, respectively , compared to 80% for the control level. Statistically
- significant adverse effects were detected at the 97.5 mg ai/kg diet level for number hatched, number hatched of eggs set, and hatchling survival. At the 315 mg ai/kg diet level, a treatment
- related reduction (p=0.042) in egg production was observed. A total of 703 eggs were laid at the 315 mg ai/kg diet level, compared to 856 for the control level, and the no. of eggs laid relative to the maximum no. of eggs laid was 59% at the 315 mg ai/kg diet level, compared to 72% for the control level. Numerous treatment
- related reductions in reproduction were adversely affected at the 1070 mg ai/kg diet level compared to the control response (percentages in parentheses below represent reductions from control values).

 eggs laid per female (p ≤0.001; 93%)
 eggs set per female (p ≤0.01; 93%)
 viable embryos (p ≤0.001; 95%)
 Live 3
- week embryos (p ≤0.001; 98%)
 % live 3
- week embryos of viable embryos (p ≤0.001; 57%)
 % normal hatchlings (p ≤0.001; 99%)
 % normal hatchlings of eggs laid (p ≤0.001; 87%)
 % normal hatchlings of eggs set (p ≤0.001; 88%)
 % normal hatchlings of live 3
- week embryos (p ≤0.001; 82%)
 % 14
- day

survivors (p ≤0.001; 99%) The control group produced a total of 558 14
- day old survivors, the 1070 mg ai/kg group produced only two 14
- day

old survivors.
 % 14
- day

survivors of eggs set (p ≤0.001; 89%) There were no treatment
- related differences observed upo n hatchling or 14
- day survivor body weights at the 39.2, 97.5, or 315 mg ai/kg diet levels. As there were onl y three hatchlings and two 14
- day

survivors at the 1070 mg ai/kg diet level, insufficient data were available to assessment these endpoints at thi s level. As of a result, the L OAEC and NOAEC based on significant reductions of hatchability (percentage of hatchlings of live 3
- week embryos, percentage of hatchling of eggs set, 14
- day survivors, and number of hatchling) were 97.5 and 39.2 mg ai/kg diet, respectively
. MRID: 47090323 The one
- generation reproductive toxicity of flutriafol to 20 pairs per level of approximately 6
- month old Northern bobwhite quail ( Colinus virginianus ) was assessed over 22 weeks. Flutriafol was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 100, 300, and 1000 mg/kg diet (not corrected for purity). Mean
- measured concentrations were <LOD1 91

(control), 95.0, 274, and 986 mg ai/kg diet, respectively
. There were no definitive treatment
rel ated effects on any adult parameter, including mortality, clinical effects, body weight, food consumption, or necropsy findings of decedent and surviving animals. In addition, no statistically
- significant differences were observed on the number of cracked eggs per female, the proportion of eggs not cracked to eggs laid, egg shell thickness, the proportion of eggs set to eggs laid, the proportion of hatchling survivors to normal hatchling, and hatchling weight. There were numerous treatment
- related reductions in reproduction at the 986 mg ai/kg diet level compared to the control response (percentages in parentheses below represent reductions from control values).

 eggs laid per female (p ≤0.001; 34%)
 eggs set per female (p ≤0.01; 32%)
 viable embryos (p ≤0.00 1; 48%)
 % viable embryos of eggs set (p ≤0.01; 19%)
 Live 3
- week embryos (p ≤0.001; 65%)
 % live 3
- week embryos of viable embryos (p ≤0.001; 47%)
 % normal hatchlings (p ≤0.001; 98%)
 % normal hatchlings of eggs laid (p ≤0.001; 98%)
 % normal hatchlings of eggs set (p ≤0.001; 98%)
 % normal hatchlings of live 3
- week embryos (p ≤0.001; 97%)
 % 14
- day

survivors (p ≤0.001; 99%) Significant adverse effects for the proportion of hatchling survivor to eggs set and 14
- day survivor weight were observed at all treatment levels. Based on statistically significant effects on survivors as a function of eggs set and body weight, a NOAEC could not be determined in this study (<95.0 mg ai/kg diet). The LOAEC was determined to be 95 mg ai/kg diet. This study

is scientifically

sound, but it does not fulfill the U.S. EPA guideline §OPPTS 850.2300 because a NOAEC could not be determined. As a result, this study is classified as SUPPLEMENTAL. The most sensitive reproductive parameters were the ratio of hatchling survival to number of e ggs set and 14
- day old survivor weight, which was adversel y affected at all treatment levels. The study needs to be repeated at lower concentrations of flutriafol to establish a reproductive NOAEC for this avian species. Supplemental Bird Studies

– Accum ulation and Depletion In a 42
- day

sub
- chronic study

(MRID 47090303), the accumulation and depletion of radioactive flutriafol was examined in tissues of mallard duck ( Anas platyrhynchos ) and bobwhite quail ( Colinus virginianus ). [14C] flutriafol was administered to groups (one pair per sex) of birds once dail y via gelatin capsule at a measured average daily dose rate of 0.21 mg/kg bw. Birds were dosed for up to 28 day s, followed by a 24
- to 360
- hour withdrawal period. Sampling of liver, kidney s, muscle (br east and leg), brain, and fat tissue occurred on Days 7, 14, 21, and 28 and at 7 and 14 day s following the final dose. Results indicated that with the exception of livers, which contained residues of 0.25
- 0.41 mg/kg and 0.17
- 0.23 mg/kg for ducks and quail, respectivel y, during the dosing period, the residues of flutriafol in bird tissue were much lower192

than the dose rate. Residues in the liver were rapidly established (b y 7 days), and did not show any significant accumulation throughout the remaining period . A rapid depletion was observed upon cessation of dosing, with residues ranging from 0.06
- 0.07 mg/kg and 0.02
- 0.04 mg/kg for ducks and quail, respectively , 192 hours after the final dose. Results in tissues of male and female birds were very

similar; expe ct for quail kidney s, where slightl y higher levels were found in male birds. Concentrations of radioactivity were very

similar in breast and leg muscle. No eggs were produced b y any of the birds during the study
. Mammals, Acute and Chronic (OPPTS 870.1100 Acute Mammalian Oral and OPPTS 870.3800 Mammalian Reproduction) Wild mammal testing is required on a case
- by
- case basis, depending on the results of lower tier laboratory

mammalian studies, intended use pattern and pertinent environmental fate characteri stics. In most cases, rat or mouse toxicity values obtained from the Agency's Health Effects Division (HED) substitute for wild mammal testing. These toxicity values are reported (Table F 11) below. Table F 11. Mammalian Toxicity with Flutriafol TGAI a nd Flutriafol 125 g/L SC Species % ai Test Type Toxicity Value Reference (Classification) Flutriafol TGAI laboratory mo use

11.9 acute oral LD 50 Males = 365 ; Females = 179 mg ai/kg
- bw MRID # 47090335 (acceptable)

laboratory rat acute oral LD 50 Male s = 1140; Females = 1480 mg ai/kg
-bw

2
- generation reproduction Parental NOAEL = 240 ppm (20.6 mg ai/kg
- dt in P males; 21.9 in P females) LOAEL = 1000 ppm (88.7 mg ai/kg
- dt in P males; 103 in P females) MRID # 47090351 (acceptable) Reproductive NOAEL = 1000 ppm

(88.7

– 103 mg ai/kg
diet) LOAEL >1000 ppm Flutriafol 125 g/L SC laboratory rat 11.9 acute oral LD 50 Males and Females: >2000 mg form /kg MRID # 47090003

(acceptable) acute dermal LD 50 Males and Females: >2000 mg form /kg MRID # 47090004

(a cceptable) LD 50 Males and Females: > 4 000 mg form /kg MRID # 4709000 5

(acceptable) In the mammalian risk assessment for flutriafol TGAI , the acute oral toxicity value of 179 mg/kg
- bw is used for assessing acute risk to mammalian species. Based the mouse and rat acute oral studies, flutriafol TGAI is moderatel y to slight toxicity to mammals. Even though there was no apparentl y reproduction effects as high as 1000 mg ai/kg
- diet, significant effects of decreased body weight gains, food consumption, and effects on the liver to parental rats and low birth index and litter size along with effects on the liver to offspring rats were observed. The TGAI NOAEL193

is 240 ppm (20.6 P males; 21.9 P females). Available toxicity data with the formulation product, Flutriafol 125 g/L SC, indicates the product acute oral value of >2000 mg form/kg is practicall y nontoxic to rats. MRID: 47090335 In an acute oral toxicity

study , groups of five male and five female Alderley Park (SPF) fasted (16
- 20 hrs before dosing) rats w ere given single gavage doses of P P450 (93% a.i.; Batch No. P10, D 2518/75) in aqueous 0.5% LI SSATAN AC at doses of 750, 1000, 1500, 2000, or 2500 mg/kg bw (10 mL/kg dose volume). Animals were dosed on day 1 and then observed for 14 day s. The animals were 5
- 7 weeks old (males: 140
- 245 g; females: 115
- 190 g) and supplied by the Animal Breeding Unit of the testing laboratory. Mortality was as follows: at 750 mg/kg bw, none; at 1000 mg/kg bw, 2 males and 1 female; at 1500 mg/kg bw, 4 males and 3 females; at 2000 mg/kg bw, 5 males and 3 females; and at 2500 mg/kg bw 5 males and 5 females. The deaths or moribund sacrifices occurred between days 2 and 8. No abnormal clinical signs were seen in females dosed at 750 mg/kg bw; all other rats showed signs of toxic ity
. Dehydration, piloerection, and upward curvature of the spine were seen in 3
- 5 animals from all of the other groups, including males at 750 mg/kg. Other notable findings included decreased abdominal tone, decreased activity, hypothermia, “sides pinche d in,” urinary incontinence or signs thereof, loss of righting reflex, shaking, and loss of stability
. Among survivors, one male from each of the 750, 1000, and 1500 mg/kg groups and one female from each of the 1500 and 2000 mg/kg groups lost weight during day s 1
- 3 or 3
- 6 with recovery by day 8. All surviving animals gained weight during the second week of the study . Red discoloration of the lungs was seen in one 1500 mg/kg male and one 2500 mg/kg male; these were animals that were sacrificed in extremis . LD 50 Males = 1140 mg/kg bw (95% Confidence Limits 880
- 1470 mg/kg bw) LD 50 Females = 1480 mg/kg bw (95% Confidence Limits 1090
- 1980 mg/kg bw) LD 50 Combined > 1000 and < 1500 mg/kg bw Based on the acute oral LD 50 , PP450 is classified as EPA Toxicity Ca tegory II I . This study is classified as acceptable. It does satisfy the guideline requirements for an acute oral study (OPPTS 870.1100; OECD 401) in the rat . MRID: 4709 0335 In an acute oral toxicity

study , groups of five male and /or five female Alderley Park (SPF) fasted (16
- 20 hours) albino mice were given single gavage doses of P P450 (93% a.i.; Batch No. P10, D 2518/75) in aqueous 0.5% LI SSATAN AC at doses of 50 (females onl y) , 100 (females onl y), 200 , 300 (males only), 350 (males only), 400, 600 (female s onl y), 800 and 1000 mg/kg bw , at a standard 10 mL/kg dose volume . Animals were dosed on day 1 and then ob served for 14 day s. The mice we re 5
- 7 weeks old, weighed 22
- 40 g, and were supplied by the Animal Breeding Unit of the testing laboratory
. Mortali ty was as follows: at 50 mg/kg 1/5F; 100 mg/kg: 4/5F; 200 mg/kg: 0/4M & 1/5F; 300 mg/kg; 0/5M; 350 mg/kg: 2/5M; 400 mg/kg: 4/5M & 1/5F; 600 mg/kg: 4/5F; 800 mg/kg: 5/5M & 5/5F; 1000 mg/kg: 5/5M & 4/4F. Deaths occurred between day 1 (the day

of dosing) and day194

4. Signs of toxicity

occurred at all dose levels, and included decreased activity , dehydration, hy pothermia, decreased abdominal tone, ptosis, piloerection, pinched in sides, upward curvature of the spine, loss of corneal reflex and loss of righting reflex. Signs of toxicity were still present in some mice on day

8. Initially, all mice had a decrease in body weight (due to fasting before the dosing). By

day 8 survivors had equaled or surpassed their initial (day
- 1) bodywei ghts. Only some of the mi ce were examined b y necropsy; the lungs of two mice (1M, 1F) dosed at 200 mg/kg appeared red in color. LD 50 Males = 365 mg/kg bw (95% Confidence Limits 312
- 434 mg/kg bw) LD 50 Females = 179 mg/kg bw (95% Conf idence Limits could not be calculated) LD 50 Comb i ned not reported Based on the mouse acute oral LD 50 , PP450 is classif ied as EPA Toxicity Category II . This study is classified as acceptable. It does satisfy the guideline requirements for an acute oral study (OPPT S 870.1100; OECD 401) in the mouse
. MRID: 4709 0351 In a two
- generation reproduction toxicity study , Flutriafol (93%; Batch # P10 ) was administered in the diet to 15 male and 30 female Wistar rats/sex/dose group at dietary levels of 0, 60, 240, or 1000 ppm (calculated to be 0, 4.8, 20.6 and 8 8.7 mg/kg bw/day in P males; and, 0, 5.5, 21.9 and 103 mg/kg bw/day

in P females ) for two successive generations with two litters per generation. The P generation animals were fed the test diets for 12 weeks prior to mating to produce the F1a litters. A fter weaning of the F1a litter, the females were mated with a different male to produce the F1b litters. On post
- natal day (PND) 36, offspring from the F1b litters were selected to be parents and were fed the same test diet concentration as their dam for 1 1 weeks prior to mating to produce the F2a litters. This procedure continued through weaning of the F2b litters which was produced b y mating of the F1b. There were no treatment
- related deaths or clinical signs of toxicity
. Treatment
- related effects on b ody weight gain, food consumption, and food utilization during the pre - mating period were observed at 1000 ppm. Body weight gains were decreased (p<=0.05, unless otherwise noted) at 1000 ppm compared to controls: throughout the pre
- mating period in the P males (decr. 6
- 8%); beginning at Week 7 in the P females (decr. 4
- 6%, not significant [NS] at Week 8); and throughout pre
- mating in the F1 females (decr. 6
- 18%; NS at Week 6). Food consumption was decreased (p<=0.05) at 1000 ppm compared to controls: generall y throughout pre
- mating in the P males (decr. 4
- 7%), resulting in a decrease in total food consumption (Weeks 1
- 12) of 2% (p<=0.01) compared to controls; beginning at Week 6 in the P females (decr. 6
- 8%), resulting in a decrease of 5% (p<=0.01) in to tal food consumption; and at Week 8 in the F1 females (decr. 6%; p<=0.01). Food utilization was increased b y 3% (p<=0.01) compared to controls in the 1000 ppm P males for Weeks 1
- 4. Food utilization was increased b y 10% (p<=0.05) over controls in the F1 females at this dose for Weeks 1
- 4, resulting in an increase of 8% (p<=0.01) for the overall (Weeks 1
- 11)195

pre - mating period. Throughout gestation , cumulative body wei ght gains were decreased b y 3
- 25 % at 1000 ppm in the P dams during both litters and in th e F1 dams during the F2b litter. With the exception of the P females on GD 8 and 22 during the F1a litter and the F1 females on GD 22 during the F2b litter , these decreases were significantly (p<=0.05) different from controls. Absolute and adjusted (for body weight) liver weights were increased (p <= 0.01) by 11
- 29% over controls in both sexes in both generations, with the exception of the absolute liver weight in the P females, which was increased b y 6% over controls (NS). Treatment
- related microscopic findings were found in the liver. Centrilobular hy pertrophy was observed in 1000 ppm males in the P generation (2/15 treated vs 0/15 controls) and F1 generation (4/15 treated vs 0/15 controls). Increased incidences of fatty change in the liver were observe d at this dose in the P generation males (8/15 treated vs 0/15 controls) and females (5/30 treated vs 1/30 controls) and in the F1 generation males (13/15 treated vs 0/15 controls) and females (3/30 treated vs 0/30 controls). Fatty change was also observe d in the 240 ppm F1 males (5/15 treated vs 0/15 controls). The LOAEL for parental toxicity is 1000 ppm ( 88.7 mg/kg bw/day in P males; and , 103 mg/kg bw/day in P females ) based on decreased body weight gains and food consumption and on effects on the live r (increased liver weights, centrilobular hypertrophy, and fatty change). The NOAEL is 240 ppm (20.6 mg/kg bw/day in P males; and , 21.9 mg/kg bw/day in P females ). Although no data were provided, it was stated that the offspring generall y remained in goo d clinical condition and that there were no clinical abnormalities which could be related to treatment. There were no effects of treatment on the offspring survival indices (percent pups surviving to PND 22 and proportion of litters with all pups survivin g to PND 22) or cumulative pup body weight gains throughout the post
- natal period. At necrops y, no macroscopic findings could be attributed to treatment. At 1000 ppm, litter size was decreased (p<=0.05) throughout the post
- natal period in the F1b litter (decr. 17
- 18%) and in the F2a litter (decr. 22
- 23%). The percent of pups born alive was decreased (p<=0.05) in the F2a litter (94.9% treated vs 100% controls) and F2b litter (90.1% treated vs 99.3% controls). The proportion of litters with all pups born alive was decreased at this dose in the F2a litter (15/20 treated vs 18/18 controls) and F2b litter (19/29 treated vs 24/26 controls). In the liver, fatty change was observed at 1000 ppm in the F1b male pups (1/7 treated vs 0/6 controls) and F1b female pups (1/6 treated vs 0/8 controls). Fine vacuolar hepatocy te vacuolation/fatty change was observed in the F2b males (5/10 treated vs 0/10 controls) and F2b females (1/10 treated vs 0/10 controls). The LOAEL for offspring toxicity is 1000 ppm (88.7 mg/kg bw/day in males; and, 103 mg/kg bw/day in females) based on decreased live birth index and litter size and on effects on the liver (fatty change/vacuolation). The NOAEL is 240 ppm (20.6 mg/kg bw/day in males; and, 21.9 mg/kg bw/day in females). There was no apparent effect of treatment on estrous cycle duration or periodicity in the P generation. There were no effects of treatment on precoital interval, gestation duration, or fertility in either litter in either generation. The LOAEL for reproductive tox icity was not196

observed. The NOAEL is 1000 ppm ( 88.7 - 103 mg/kg bw/day). This study is classified as acceptable/guideline and satisfies the guideline requirements (OPPTS 870.3800; OECD 416) for a two
- generation reproduction study in the rat.
MRID: 47090 003 In an acute oral toxicity

study (MRID 47090003 ), 5/sex of Alpk: AP f SD (Wistar
- derived) rat s (age: 8
- 12weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire; 355
- 419 g males and 214
- 248 g females) were given a single oral dose of Flutriafol 125 g/l SC formulation (Batch Reference Number F
- 100; Formulation Reference Number YF7440E; Purity
- 11.9%; cream colored liquid) at a dose of 2000 mg/kg administered by oral gavage. Animals were th en observed for 14 day s. Oral LD 50 Males > 2000 mg/kg Oral LD 50 Females > 2000 mg/kg Oral LD 50 Combined > 2000 mg/kg All animals survived and gained weight. No signs of toxicity were observed. Gross necrops y revealed a red area on the lungs o f one animal which is not considered to be treatment related. Toxicity based on no deaths at the limit dose of 2000 mg/kg. This acute oral study is classified as Acceptable. It does satisfy the guideline requirement for an acute oral study

(OPPTS 870 .1100; OECD 401) in the rat. However, OECD 401 is now an unacceptable protocol. The preferred protocol is OECD 425: Acute Oral Toxicity
- Up
- and
Down Procedure. MRID: 47090004 In an acute dermal toxicity study (MRID 47090004 ), 5/sex of Alpk:AP f SD rats (age: 8
- 12 weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK 353
- 397 g males and 211
- 235 g females) were dermall y exposed to Flutriafol 125 g/l SC formulation (Batch Reference Number F
- 100; Formulation Reference Number YF74 40E; Purity
- 11.9%; cream colored liquid). Two thousand mg/kg of body weight of the test substance was applied evenl y to a dose area of approximately 7 cm x 7 cm on the back of each animal. The test sites were covered with an occlusive dressing which consi sted of a gauze patch covered b y a patch of plastic film held in position by an adhesive bandage secured with tape. After a period of 24 hours, the dressings were removed and the sites were cleansed. Animals were then observed for 14 day s. Dermal LD 50 Males > 2000 mg/kg bw Dermal LD 50 Females > 2000 mg/kg bw Dermal LD 50 Combined > 2000 mg/kg bw Three animals lost weight the first week; all animals except one gained weight b y the end of the study . There were no signs of sy stemic toxi city . Ery thema was noted at 4/10 dose sites resolving b y day

3. Desquamation was noted at one site resolving b y day 9. No macroscopic197

abnormalities were noted at necrops y. Toxicity based on no deaths at the limit dose. This acute dermal study

is cla ssified Acceptable. It does satisfy the guideline requirement for an acute dermal study

(OPPTS 870.1200; OECD 402) in the rat. MRID: 47090005 Inan acute dermal toxicity study (MRID 47090005 ), 5/sex of Alpk:AP f SD rats (age: 8
- 12 weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK 340
- 416 g males and 236
- 276 g females) were dermall y exposed to Flutriafol 125 g/l SC formulation (Batch Reference Number F
- 100; Formulation Reference Number YF7440E; Purity
- 11.9%; cream colored liquid). Four thousand mg/kg of body weight of the test substance was applied evenl y to a dose area of approximately 7 cm x 7 cm on the back of each animal. The test sites were covered with an occlusive dressing which consisted of a gauze patch covered b y a patch of plastic film held in position by an adhesive bandage secured with tape. After a period of 24 hours, the dressings were removed and the sites were cleansed. Animals were then observed for 14 day s. Dermal LD 50 Males > 4000 mg/kg bw Dermal LD 50 Females > 4000 mg/kg bw Dermal LD 50 Combined > 4000 mg/kg bw All animals survived. Three females lost weight the first week; all animals except one gained weight b y the end of the study . Stains around the nose and/or staining with urine were seen in all animals on day s 1 or 2. Ery thema and/or edema were noted at all dose sites resolving by day 7. Desquamation was noted at 9/10 sites resolving by day 14. No macroscopic abnormalities were noted at necrops y. Toxicity based on no death s at 4000 mg/kg. This acute dermal study

is classified Acceptable. It does satisfy the guideline requirement for an acute dermal study

(OPPTS 870.1200; OECD 402) in the rat. Non -target Beneficial Insects, Acute (OPPTS 850.3020 Honeybee Acute Contact) An acute contact study using the TGAI is required to establish the toxicity of flutriafol to beneficial insects. The preferred test species is honeybees. Results of the test are tabulated below (Table F 12). Table F12 . Acute Contact and Oral Toxicity of Flutriafol Technical to Honeybees Species % ai LD50/LC50 (μg ai/bee) Toxicity

Category* MRID No. Study Classification Honey be e 93 >50 (contact) Practically non
toxic 47090326

McIntosh and Acceptable198

Table F12 . Acute Contact and Oral Toxicity of Flutriafol Technical to Honeybees >2 (oral) Not categorized Wilkinson. 1982. Suppl emental † † Acute oral
- a non - guideline study * The LD 50 s were greater than the highest concentration; therefore, it was not possible to calculate a probit slope and 95% confidence interval. Because the LD 50 is greater than 11 μg ai/bee, flutriafol TGAI is categorized as practically non toxic to honey

bees on an acute contact basis. The guideline (OPPTS 850.3020) is fulfilled. By 48 hours in the first contact test with f lutriafol t echnical, mortality was 6.7% in the control and 0, 13.3, 3.3, 0.0 and 3.3% in the 1.0, 5.0, 10, 20 and 50 μg ai/bee treatment groups, respectivel y; no sub
- lethal effects were reported. By 48 hours in the second contact test with f lutriafol t echnical, mortality was 0% in the control and 3.3, 0, 3.3, 6.7 and 0% in the 1.0, 5 .0, 10, 20 and 50 μg ai/bee treatment groups, respectively ; no sub
- lethal effects were reported. Additional supplemental honey bee oral toxicity test indicate s the oral 48
- h L C 50 for flutriafol is >2 μg ai/bee (MRID 47090326). By 48 hours in the first oral test with f lutriafol t echnical, mortality was 0% in the control and 6.7% in the single treatment group; no sub
- lethal effects were reported. By

48 hours in the second oral test with f lutriafol t echnical, mortality was 0% in the control and 2.0 μg ai/bee treatment group and no sub
- lethal effects were reported. Additional Honeybee T oxicity S tudies with Formulation Product of Flutriafol Additional honey

bee studies were also submitted by the registrant on the flutriafol formulation product, Flutriafol 125 g/l SC. Results are tabulated below ( Table F 12 a).

Table F 12a. Acute Toxicity of Formulation Products of Flutriafol to Honeybees Species % ai Toxicity Value Toxicity Category* MRID No. Study Classification Honey bee (contact) 12.7 LD 50 >52.5 μg ai/ bee N/A 47090326 A McIntosh and Wilkinson (1982) Acceptable LD 50 >10.5 μg ai/bee N/A Acceptable Honey bee (oral; non
- guideline study) LC 50 = 47 μg ai/bee N/A Supplemental 1 LC 50 >50 μg ai/bee N/A Supplemental 1 Honey bee (contact) 12.1 LD 50 > 1280 μg/bee or >1% of sucrose N/A 47090327 B Kleiner, R (1994) Acceptable Honey bee (oral; non
- guideline study) LC 50 >198 μg /bee (>24 μg ai/bee) N/A Supplemental 1

* The LD 50 s were greater than the highest concentration tested; therefore, it was not possib le to calculate a probit slope and 95% confidence intervals. A Based on SC JF 8496 formulation product B Based on IMPACT formulation product 1 N ot an EPA guideline study Form = formulation product; ai = active ingredient; N/A = not available199

Results of LD 50 s > 52.5 μg ai/bee and > 1280 μg/bee ( or 1% of sucrose ) indicate that honey bees were not effected to IMPACT or SC JF 8496 formulation products containing flutriafol on an acute contact basis
. The acute contact studies are scientifically sound and fulfill the OPPTS 850.3020 guideline requirement for acute toxicity to beneficial insects. SC JF 8496 Formulation Product of Flutriafol (MRID: 47090326) The honey

bee, ( Apis mellifera ), was exposed to SC JF 8496 (formulation containing flutriafol Technical) for 48 hours in two oral and two contact tests for a total of four definitive toxicity tests. In the two contact tests with SC JF 8496, bees were treated with two ranges of concentrations. One series with the formulation product of SC JF 8496 was prepared wi th acetone and water that consisted of nominal concentrations of 0 (control), 1.0, 2.1, 5.2 and 10.5 μg ai/bee. The second series with the formulation product of SC JF 8496 was prepared with water onl y and consisted of nominal concentrations of 0 (control ), 5.2, 10.5 and 52.5 μg ai/bee. By 48 hours in the first contact test with SC JF 8496, mortality was 0% in the control and 0, 10.0, 10.0 and 0% in the 1.0, 2.1, 5.2 and 10.5 μg ai/bee treatment groups, respectivel y; no sub
lethal effects were reported. In the second contact test with SC JF 8496, mortality was 0% in the control and 0, 0 and 3.3% in the 5.2, 10.5 and 52.5 μg ai/bee treatment groups, respectivel y; no sub
- lethal effects were observed. By 48 hours in the first oral test with SC JF 8496, mortality was 3.3% in the control and 10, 3.3, 3.3, 13 and 57% in the 1.0, 5.0, 10, 20 and 50 μg ai/bee treatment groups, respectively ; no sub
- lethal effects were reported. In the second oral test with SC JF 8496, mortality

was 0% in the control and 3.3, 0, 0 , 3.3 and 47% in the 1.0, 5.0, 10, 20 and 50 μg ai/bee treatment groups, respectivel y; no sub
- lethal effects were reported. The LC 50 values for the first and second oral tests with SC JF 8496 were 47 and >50 μg ai/bee, respectivel y. The LD 50 values for the first and second contact tests with SC JF 8496 were both > 10.5 and > 52.5 μg ai/bee , respectively
. As a result, SC JF 8496 is categorized as practically nontoxic at concentrations of >10.5 and >52.5 μg ai/bee to honey bee on an acute contact basis. IMPA CT Formulation Product of Flutriafol (MRID: 47090327) The honey

bee, Apis mellifera L. , was exposed to IMPACT (formulation containing the active ingredient flutriafol) for 24 hours in the oral test and for 72 hours in the direct contact test. The oral nominal concentrations were 0 (control) and 1% of the sucrose feeding solution or 1280 μg/bee. The actual intake concentration of flutriafol in the single treatment level of the oral toxicity test was 198 μg/bee; however, it was not specified is this concentr ation was based on the active ingredient or the formulated product. Additionally , the 1280 μg/bee treatment was used in the contact test. By

24 hours in the oral test, mortality was 0% in the control and 3% in the 198 μg/bee treatment level. By 72 hours in the direct contact test, mortality was 2% in the control and 0% in 1280 μg/bee treatment level. No sub
- lethal effects were observed in any of definitive tests. The L C 50 value for the oral test was >198 μg/bee. The LD 50 value for the direct contact test was > 1280 μg/bee
. As a result, IMPACT is categorized as practically non
- toxic at a concentration of 1280 μg/bee to honey bees on an acute contact basis. Toxicity to Terrestrial Plants200

Terrestrial plant testing (seedling emergence and vegetative vigor) is required for fungicides that have terrestrial non
- residential outdoor use patterns and that may move off the application site through volatilization (vapor pressure >1.0 x 10 - 5 mm Hg at 25 o C) or drift (aerial or irrigation) and/or that may

have endangered or threatened plant species associated with the application site. For seedling emergence and vegetative vigor testing the following plant species and groups should be tested: (1) six species of at least four dicotyledonous families, one species of which is soy bean ( Glycine max) and the second is a root crop, and (2) four species of at least two monocotyledonous families, one of which is corn (Zea mays ). Tier I tests measure the response of plants, relative to a control, at a test level that is e qual to the highest use rate (expressed as lbs ai/A). Terrestrial Plants, Seedling Emergence and Vegetative Vigor (OPPTS 850.4100 and 850.4150 - Tier I) Results of Tier I testing are presented in the following table (Table F13):
Table F13. Nonta rget Terrestrial Plant Seedling Emergence and Vegetative Vigor Toxicity (Tier I) 1 Species Seedling emergence Vegetative vigor Endpoint 2 % inhibition Endpoint 2 % inhibition

Monocots : Corn Length 4.8 Length 0.9 Onion Weight 6.9 None
- 4.2 Ryegrass Emergence 8.8 Weight 17.1 Wheat Length 1.6 Length 0.9 Dicots : Cabbage Weight 6.1 None
- 6.5 Lettuce Weight 6.8 None
- 4.5 Radish Length 2.8 Weight 6.7 Soybean Weight 9.0 Weight 1.8 Sugarbeet Emergence 3.2 Weight 15.1 To mato None 0.0 None
- 6.0 1 MRIDs no. 47090328 and 47090329; Porch, Martin, and Krueger (2006); 11.9% ai; application rate = 0.12 lb ai/A 2 only the most sensitive endpoint is tabulated Negative % inhibition = growth Seedling Emergence (MRID : 47090328) The effect o f Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol; 11.9%) on the seedling emergence of monocot and dicot crops was studied at mean - measured application rates of 0 (negative and blank controls) and 0.12 lbs ai/A. The growth m edium used in the seedling emergence test was natural soil, classified as a sandy loam soil, with a pH of 7.3 and an organic matter content of 2.2%. Survival, emergence, dry weight and plant height were not significantl y affected in any of the species tes ted. The percentage inhibition in seedling201

emergence in the treated species as compared to the control ranged from
- 9.4% to 8.8%. The most sensitive monocot species, based on an 8.8% inhibition in emergence relative to the negative control, in the seedling emergence test was ryegrass with an EC 25 of >0.12 lbs ai/A and a N OAEC of ≥0.12 lbs ai/A. The most sensitive dicot species, based on a 9.0% inhibition in dry weight relative to the negative control, was so ybean with an EC 25 of >0.12 lbs ai/A and a NOAEC of ≥0.12 lbs ai/A. Corn and tomato were the only species to exhibit no compound
related phyt otoxic effects. There were no clear dose
- dependent effects for the remaining species; however, slight to severe effects were observed in a few instances and effects included leaf curl, necrosis and chlorosis. The guideline (OPPTS 8 50.4100) is fulfilled (MRID 47090328). A seedling emergence multiple
- dose (Tier II) test is not required because none of the test species were inhibited more than 25% or had a significant effect at the maximum application rate of 0.12 lb ai/A. Vegetative Vigor (MRID : 47090329) The effect of Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol; 11.9%) on the vegetative vigor of monocot and dicot crops was studied at mean - measured application rates of 0 (negative and blank controls ) and 0.12 lbs ai/A. The growth medium used in the vegetative vigor test was natural soil, classified as a sandy loam soil, with a pH of 7.3 and an organic matter content of 2.2%. Rye grass was the only species in which plant dry weight was significantl y affected by

Flutriafol 125 g/L SC treatment; plant height and survival were not significantl y affected in any species. The most sensitive monocot, based on a 17.1% inhibition in dry weight relative to the negative control, was ryegrass with NOAEC and EC 25 values of < 0.12 and >0.12 lbs ai/A, respectivel y. The most sensitive dicot, based on a 15.1% inhibition in dry weight relative to the negative control, was sugar beet with NOAEC and EC 25 values of ≥0.12 and >0.12 lbs ai/A, respectivel y. One or more incidental signs of phy to toxicity, such as necrosis, chlorosis, leaf curl and mortality were observed, however, these signs were infrequent and observed on plants from both the treatment and co ntrol groups, and therefore were not attributed to treatment. The guideline (OPPTS 850.4150) is fulfilled (MRID 47090329). A vegetative vigor multiple
- dose (Tier II) test is required for ryegrass because the test species was significantl y effected at the m aximum application rate of 0.12 lb ai/A. All other species were not inhibited 25% or more and were not significantl y affected at the maximum rate. OPPTS 850.4250

– Tier II Results of Tier II testing with ryegrass are presented in the following table (Ta ble F13 a): Table F13a . Summary of Tier II Vegetative Vigor Results for Flutriafol 125 g/L SC with Ryegrass* Species EC50

(lb ai/A) EC25

( lb ai/A) N OAEC

( lb ai/A) Affected

endpoints MRID no.

Author/Year Study

classification Ryegrass >0.26 >0.26 0.26 None 47689801 Porch, Martin, and Krueger. 2009. Acceptable * 11.9% flutriafol, tested at the maximum application rate of 0. 26 lb ai/A202

Vegetative Vigor (MRID 47689801) The effects of Flutriafol 125 g/L SC (AI: Flutriafol) on the vegetative vigor of the monocot ryegrass ( Lolium perenne ) was studied at nominal concentrations of 0 (negative control), 8.40, 16.8, 33.5, 67.0, 134, and 268 g ai/ha, which were equivalent to 0 (negative control), 0.0075, 0.015, 0.030, 0.060, 0.12, and 0.24 lbs ai/A. Measured concentrations were <LOQ (<0.000002, negative control), 0.0081, 0.016, 0.032, 0.064, 0.13, and 0.26 lbs ai/A. The growth medium used in the vegetative vigor test was a mixture of artificial and natural soil, representing a sandy loam, with 1.0% organic carbon, and a pH of 6.2. On Day 21 the surviving plants per pot were measured, recorded and cut for determining the plant dry weight and height. There was no inhibition in survival in ryegrass. The study author’s results indicated that the level of inhibition in plant height and dry

weight was very

low as compared to the control mean (range: 1
- 8% and 0
- 11%, respectivel y) and no clear dose
- response relationship was evident. No phy totoxic effects were observed
. There were no sensitive endpoints for ryegrass, resulting in overall NOAEC, LOAEC, and EC 25 values of 0.26, >0.26, and >0.26 lbs ai/A, respectivel y.203



### Appendix G. Flutriafol Ecological Effects Bibliography Ecological Effects MRID Studies Submitted to EPA Guideline: OPPTS 850.2100 Avian Single Dose Oral Toxicity

------------------------------------------------------------------------------------- MRID: 47090318 (old MRID: 163464) Roberts , N.; Fairley, C. 1982. The Acute Oral Toxicity (LD50) of PP450 to the Mallard Duck. Unpublished study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. ICI/419/82559. Study sponsored by Im perial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study completed on August 13, 1982. 22 pages. MRID: 47090319 Roberts , N.; Fairley, C. 1982. The Acute Oral Toxicity (LD50) of PP450 to the Red
- Legged Partridge. Unpublished study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. ICI 420/82808. Study spo nsored by Im perial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study submitted on November 4, 1982. 26 pages. MRID: 47471301 Hubbard, P.; Beavers, J. 2008. Flutriafol: An Acute Oral Toxicity Study with the Northern bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory Study No. 232/138. Study sponsored by Im perial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study submitted on May 8, 2008. 74 pages. Guideli ne: OPPTS 850.2300 Avian Dietary Toxicity

------------------------------------------------------------------------------------- MRID: 47090320 (old MRID: 163465) Roberts, N.; Fairley, C.; Almond, R. 1982. The Subacute Dietary Toxicity (LD50) of PP450 to the Mallard Duck. Unpublished study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. ICI 421 WL/82630. Study sponsored by Imperi al Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study submitted on November 26, 1982. 34 pages. MRID: 47090321 (old MRID: 163680) Roberts, N., et al. 1986. The Subacute Dietary Toxicity of Flutriafol to the Bobw hite Quail. Unpublished study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Camb ridgeshire, UK. Laboratory Study No. ISN 79BT/86200/2. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. S tudy

submitted on August 6, 1986 . 27 pages. Guideline OPPTS 850.2300 Avian Reproduction

-------- ----------------------------------------------------------------------------- MRID: 47090322 Tem ple, D.; Frey, L.; Beaver, J.; et al. 2007. Flutriafol: A Reproduction Study with the Mallard. Unpublished study performed by Wildlife International Ltd., Easto n, MD. Laboratory Study No. 232
- 127. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study submitted on March 7, 2007. 227 pages. MRID: 47090323 Thompson, H.M. 2007. Flutriafol: Assessment to Determine the Effects on Reproduction in the Bobwhite Quail ( Colinus virginianus ). Unpublished study performed by Environmental Risk Assessment Team, Environmental Biology Group, Central Science Laboratory, York, UK. Laboratory Study No. K3AQ1001. Study submitted by Cheminova A/S, Lemvig, Denmark. Study initiated September 18, 2002, completed on August 3 2007 and originally submitted January 23, 2004. Amended report submitted March 2007. 174 pages.204

MRID: 47090324 Reiss, R. 2007. Analysis of Hatchling Survival in a Bobwhite Quail Reproduction Study for Flutriafol. Unpublished study performed by Expo n ent, Alexandria, VA. Study sponsored by Cheminova A/S, Lemvig, Denmark, and submitted by Cheminova, Inc., Arlington, VA on March 20, 2007. 17 pages. Guideline OPPTS 850.10 75 Freshwater and Saltwater Fish Acute Toxicity

----------------------------------------------------------------------------------------------- MRID: 47090308 Palmer, S.J., C.A. Sutherland, T.Z. Kendall and H.O. Krueger. 2006. Flutriafol: A 96
- Hour Stati c Acute Toxicity with the Sheepshead Minnow ( Cyprinodon variegatus ). Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number 232A
- 106. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed No vember 21, 2006. 64 pages MRID: 47090309 Palmer, Susan J., C.A. Sutherland, T.Z. Kendall, and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 96
- Hour Static Ac ute Toxicity Test with the Bluegill ( Lepomis macrochirus ). Unpublished study performed by Wildli fe International, Ltd., Easton, MD. Laboratory report number 232A
- 105. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed November 22, 2006. 64 pages. MRID: 47090310 (old MRID: 163467) Hill, R.W. 1985. Flutriafol: Determination of Acute Toxicity to Bluegill Sunfish ( Lepomis macrochirus ). Unpublished study performed by Imperial Chemical Industries PLC, Brixham, Devon, TQ5 8BA. Laboratory report number BL/B2684. Study sponsored by Imperial Chemical Industries, PLC and submitted by Che minova A/S, Arlington, VA. Study completed August 19, 1985. 15 pages. MRID: 47090311 (old MRID: 163466) Hill, R.W. 1982. PP450: Determination of the Acute Toxicity to Rainbow Trout ( Salmo gairdneri). Unpublished study performed by Imperial Chemical Industries PLC, Brixham, Devon TQ5 8BA. Laboratory report number J013/B. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study completed August 18, 1982. 21 pages. MRID: 47090312 Sankey, S.A. 1993. F lutriafol: Acute T oxicity to Rainbow T rout ( Oncorhynchus mykiss ) of a 125 g/L SC F orm ulation. Unpublished study performed by Brixham Environmental Laboratory, Brixham, Devon, TQ5 8BA, U.K. Laboratory report number BL4646/B. Study sponsored by Zeneca Agrochemicals, Surrey GU27 3JE, U.K. and submitted by Cheminova, Inc., Arlington, VA. Study completed April 14, 1993. 24 pages. Guideline OPPTS 850.1010 Freshwater Invertebrate Acute Toxicity

----------------------------------------------------------------- ---------------------------- MRID: 47090304 (old MRID: 163468) Hamer, M.J. and I.R. Hill. 1982. PP450: Toxicity to First Instar Daphnia magna . Unpublished study performed by Im perial Chemical Industries, Plant Protection Division, Jealotts Hill Research Station, Bracknell, Berkshire RG 12 6EY. L aboratory report number RJ 0264B. S tudy sponsored by Imperical Chemical Industries and submitted by Cheminova, Inc., Arlington, VA. Study completed September 14, 1982. 13 pages. MRID: 47090305 Kent, S.J. 1994 . Flutriafol: Acute Toxicity to Daphnia magna of a 125 g/L SC Formulation. Unpublished study performed by Brixham Environmental Laboratory, Brixham, Devon TQ5 8BA, U.K. Laboratory report number BL5240/B. Study sponsored by Zeneca Agrochemicals, Fernhur st Haslmere, Surrey GU 27 3JE, U.K. and submitted by Cheminova, Inc., Arlington, VA. Study completed December 13, 1994. 25 pages.205

Guideline OPPTS 850.1025 Estuarine/Marine Mollusk Toxicity (Shell Deposition)

--------------------------------------------- ---------------------------------------- MRID: 47090306 Palmer, S.; Sutherland, C.; Kendall, T.; Krueger, H. 2006. Flutriafol: A 96
- Hour Shell Deposition Test with Eastern Oy ster ( Crassostrea virginica ). Unpublished study performed by Wildlife Internationa l, Ltd., Easton, MD. Laboratory report no. 232A
- 108. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study completed November 21, 2006. 62 pages. Guideline OPPTS 850.1035 Estuarine/Marine Invertebrate Toxicity

---------------------------- --------------------------------------------------------- MRID: 47090307 Palmer, S.; Sutherland, C.; Kendall, T.; Krueger, H. 2006. Flutriafol: A 96
- Hour Static Acute Toxicity Test with the Saltwater Mysid (

Americamysis bahia ). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory report no. 232A
- 107. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study completed November 21, 2006. 63 pages. Guideline OPPTS 850.1300 Freshwater Aquatic Invertebrate Life Cycle

------------------------------------------------------------------------------------- MRID: 47090314 Williams, B.R.H., et al. 1990. Flutriafol: Determination of Chronic Toxicity to Daphnia magna . Unpublished study performed by Imperial Chemical Industries PLC, Brixham, Devon, UK. Laboratory Report No. BL3840/B. Study sponsored by ICI Agrochemicals, Fernhurst, Haslemere, Surry, UK, and submitted by Cheminova, Inc., Arlington, VA. Study initiated April 30, 1990 and submitted Augu st 30, 1990. 24 pages. MRID: 47090315 B ätscher, R. 2004. Influence of Flutriafol Technical on Survival and Reproduction of Daphnia Magna in a Semi
Static Test over Three Weeks. Unpublished study performed by RCC Ltd., Itingen, Switzerland. Laborato ry Report No. 847686. Study sponsored and submitted by Cheminova, Inc., Arlington, VA. Study initiated September 16, 2003 and submitted March 25, 2004. 70 pages. MRID: 47090316 B ätscher, R. 2004. Influence of CHA 1310
- 03 on Surv ival and Reproduction of Daphnia Magna in a Semi
- Static Test over Three Weeks. Unpublished study performed by RCC Ltd., Itingen, Switzerland. Laboratory Report No. 847692. Study sponsored and submitted by Cheminova, Inc., Arlington, VA. Study initiate d September 16, 2003 and submitted March 25, 2004. 70 pages. Guideline OPPTS 850.1400 Freshwater Fish Early- Life Stage

------------------------------------------------------------------------------------- MRID: 47090317 Palmer, S.J. , T.Z. Kendall, and H.O. Krueger. 2007. Flutriafol: An Early Life
- Stage Toxicity Test with the Fathead Minnow (Pimephales promelas ). Unpublished study performed by Wildlife International., Ltd., Easton, MD. Laboratory Project No. 232A
- 109. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study initiated August 24, 2006 and submitted February 1, 2007. 101 pages. Guideline OPPTS 850.3020 Honeybee Acute Contact Toxicity

------------------------------------------------------- ------------------------------ MRID: 47090326 McIntosh, S.; Wilkinson, W. 1982. PP450 (Flutriafol Technical and End
- Use Formulation): Acute Oral and Contact Toxicity to Honey Bees. Unpublished study performed by Imperial Chemical Industries PLC, Bracknell, Berkshire, RG12 6EY. Laboratory Project Identification No. RJ0277B. Study sponsored by Imperial Chemical Industries PLC, Bracknell, Berkshire, England, and submitted by Cheminova, Inc., Arlington, VA. Study completed September 21 1982. 22 pages.206

MRID: 4 7090327 Kleiner, R. 1994. Testing Toxicity to Honeybee
- Apis mellifera L. (Laboratory) According to BBA Guideline VI, 23
- 1 1991. Unpublished study performed by BioChem GmbH , Karlsruhe , Germany. Laboratory Project No. 94 10 48 037. Study sponsored by Zeneca Agro , Emil
- von - Behring

– Str. 2 , 60439 Frankfurt/M , Germany and submitted by Cheminova, Inc., Arlington, VA. Study completed Aug 18 1994. 19 pages. Guideline OPPTS 850.4100 Seedling Emergence

-------------------------------------------------------------- ----------------------- MRID: 47090328 Porch, J.R., K.H. Martin and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants. Unpublished study performed by Wil dlife International, Ltd., Easton, MD. Laboratory Report No. 232
- 13 3 . Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study completed November 13, 2006. 86 pages. Guideline OPPTS 850.4150 Vegetative Vigor

-------------------------------- ----------------------------------------------------- MRID: 47090329 Porch, J.R., K.H. Martin and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants. Unpubl ished study performed by Wildlife International, Ltd., Easton, MD. Laboratory Report No. 232
- 134. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study completed November 13, 2006. 106 pages. Guideline OPPTS 850.4 2 50 Vegetative Vigor

--- --------------------------------------------------------------------------------------------------- MRID: 47689801 Porch, J.R., Krueger, H.O., and Martin, K.H. 2009. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ryegrass. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Project No.: 232
- 147. Study sponsored by Cheminova A/S, Denmark. Study completed February 26, 2009. Guideline OPPTS 850.4400 Aquatic Vascular Plant Toxicity

------------------------------------------------------------------------------------- MRID: 47090330 Desjardins, D., T.Z. Kendall and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 7
- Day Toxicity Test with Duckweed (

Lemna gibba G 3). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory report number 232A
- 110. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed December 21, 2006. 71 pages. Guideline OPPTS 850.5400 Algal Plant Toxicity

------------------------------------------------------------------------------------- MRID: 47090331 Desjardins, D., T.Z. Kendall and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 96
- Hour Toxicity Test with the Marine Diatom ( Skeletonema costatum ). Un published study performed by Wildlife International, Ltd., Easton, MD. Laboratory report number 232A
- 113. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed December 21, 2006. 73 pages. MRID: 47090332 Desjardins, D., T.Z. Kendall and H. O. Krueger. 2006. Flutriafol 125 g/L SC: A 96
- Hour Toxicity Test with the Freshwater Diatom (Navicula pelliculosa ). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory report number 232A
- 112. Study sponsored by Cheminov a A/S, Lemvig, Denmark. Study completed December 21, 2006. 74 pages.207

MRID: 47090333 Desjardins, D., T.Z. Kendall and H.O. Krueger. 2007. Flutriafol 125 g/L SC: A 96
- Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella subcapitata ). Unpubli shed study performed by Wildlife International, Ltd., Easton, MD. Laboratory report number 232A
- 111. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed January 15, 2007. 74 pages. MRID: 47090334 Desjardins, D., T.Z. Kendall and H.O. Kr ueger. 2007. Flutriafol 125 g/L SC: A 96
- Hour Toxicity Test with the Freshwater Alga (

Anabaena flos

- aquae). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory report number 232A
- 114. Study sponsored by Cheminova A/S, L emvig, Denmark. Study completed January 15, 2007. 72 pages. Non - guideline Studies

-------------------------------------------------------------------------------------------- MRID: 47090303 Hawkins, D.R., et al . 1987. Accumulation and Depletion of radioa ctive Residues in the Tissues of Mallard Duck and Bobwhite Quail Following Oral Doses of 14 C
- Flutriafol. Unpublished study performed by Huntingdon Research Centre Ltd., Huntingdon, Cambridgeshire, England. Laboratory Project No. ISN 138/87956. Study sponso red by Im perial Chemical Industries PLC, Bracknell, Berkshire, England, and submitted by Cheminova, Inc., Arlington, VA. Study submitted on August 12, 1987. 44 pages.208



### Appendix H . Environmental Fate Bibliography Hydrolysis Hawkins, D.R., L.F. Elsom, and R. Jackson. 1987. PP450: a hydrolysis study in aqueous solution at pH 5, 7, and 9. Unpublished study performed by

Huntingdon Research Centre Ltd., Cambridgeshire, United Kingdom (p.22); sponsored by Imperial Chemical Industri es PLC (location not reported); and submitted by Cheminova, Inc., Arlington, Virginia. Report No.: HRC/I SN 136/87510. Experimental start date March 3, 1987 and completion date April 16, 1987 (p.12). Final report issued June 10, 1987
. MRID 47090416 Aque ous Photolysis Skidmore, M.W. 1987. Flutriafol: a photol ys is study in aqueous solution at pH 7. Unpublished study performed b y Huntingdon Research Centre Ltd., Cambridgeshire, England (pp.8, 13); sponsored b y IC I P LC Plant Protection Division, Jealott’ s Hill Research Station, Berkshire, England; and submitted by Cheminova Inc., Arlington, Virginia. Study Number: PP450AG03. Report No.: RJ 0607B. Experimental start April 13, 1987 and completion June 16, 1987 (Appendix A, p. 24). Final report issued Dec ember 9, 1987. MRID 47090417 Moffatt, F. 1994. Flutriafol: environmental half
- life and quantum yi eld for direct phototransformation in aqueous solution. Unpublished study performed and sponsored by Zeneca Agrochemicals, Bracknell, Berkshire; and submitted by Cheminova Inc., Arlington, Virginia. Study Number: 93JH187. Report No.: RJ 1581B. Experimental start August 1993 and completion December 1993 (p.10). Final report issued January 27, 1994. MRID 47090418 Soil Photolysis Snow, A.D. and B.D. Cavel l. 1982. PP450: photoly sis on a soil surface. Unpublished study performed and sponsored by I CIPLC Plant Protection Division, Jealott’s Hill Research Station, Berkshire, England; and submitted by Cheminova Inc., Arlington, Virginia. Report No.: RJ 0289 B. Experimental start and completion dates not reported. Final report issued December 16, 1982. MRID 47090420 Hiler, T., and A. Lopez. 2008. Photodegradation of [ 14 C]flutriafol in/on soil by artificial light. Unpublished study

performed by

PTRL West , Inc., Hercules, California. Study sponsored and submitted by

Cheminova A/S, L emvig, Denmark. PTRLReport No.: 1719W
- 1. PTRLProject No.: 1719W. Experiment started January 8, 2008 and completed February 9, 2008 (p. 15). Final report issued April 21 , 200 8
. MRID 47418401 Aerobic Soil Metabolism Hiler, T. 2006. Aerobic soil metabolism of [ 14 C]flutriafol. Unpublished study performed by PTRLWest, Inc., Hercules, California; sponsored by Cheminova A/S, Lemvig, Denmark; and submitted by

Cheminova, In c., Arlington, Virginia. PTRLWest Study No.: 1351W and Report No.: 1351W
- 1. Experiment started March 25, 2005; a completion date was not reported (p.12).209

Final report issued September 20, 2006. MRID 47090421 Vincent, J., B.R. Harvey , D.J. Arnold and I .R. Hill. 1982. PP450: degradation in laboratory incubated soils. Unpublished study performed by

I CIPlant Protection Division, Berkshire, England. Sponsored b y Imperial Chemical Industries PL C and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: RJ 0287B. The experiment initiation and completion dates were not reported. Final report issued November 26, 1982. MRID 47090422 Swaine, H., A. Sapiets and S. Robertson. 1982. PP450: L aboratory study of the degradation in two German Standard Soils and a United Kingdom soil. Unpublished study performed by

I CI Plant Protection Division, Berkshire, United Kingdom; sponsored by Imperial Chemical Industries PLC (ICI agrochemicals are now part of AstraZeneca) and sub mitted by Cheminova, In c., Arlington, Virginia. L aboratory Report No.: RJ 0297B. The experiment start and completion dates were not reported. Final report issued December 17, 1982. MRID 47090423 Anaerobic Soil Metabolism Hiler, T. 2006 . Anaerobic aquatic metabolism of [ 14 C]flutriafol. Unpublished study performed by PTRL West, Inc., Hercules, California (p.1); sponsored by Cheminova A/S, L emvig, Denmark; and submitted by Cheminova, Inc., Arlington, Virginia. PTRL Study No.: 1352W and Report No.: 13 52W
- 1. Experimental start date May 17, 2005 and completion date June 1, 2006 (Table II, p.33). Final report issued September 20, 2006
. MRID 47090424 Aerobic Aquatic Metabolism Waring, A.R. and P. Yeomans. 1993 . ( 14 C)
- Flutriafol: the degradation in water/sediment sy stems. Unpublished study performed by

Hazelton Europe, North Yorkshire, United Kingdom; sponsored b y Zeneca Agrochemicals, Berkshire, United Kingdom; and submitted by Cheminova, In c., Arlington, Virginia. Hazelton Report No.: 38/178
- 1015 (p.1). Experimental start date March 22, 1993, and completion date September 22, 1993 ("practical phase" of study; p.13). Final report issued November 9, 1993
. MRID 47090419 Adsorption/Desorption Hiler, T. 2006. Soil adsorption/desorption of [ 14 C] flutriafol by the batch equilibrium method. Unpublished study

performed by

PTRL West, Inc., Hercules, California; and sponsored and submitted by

Cheminova A/S, L emvig, Denmark. PTRLWest Project Number: 1353W and PTRLWest Report Number: 1353W
- 1. Experi mental start date May 18, 2005, and completion date June 28, 2005 (p.11). Final report issued May 17, 2006. MRID 47090425 Völkel, W. 2004. Adsorption/desorption of 14 C
- flutriafol on two soils. Unpublished study performed b y RCC Ltd., Itingen, Switzerl and; sponsored by Cheminova A/S, L emvig, Denmark; and submitted by

Cheminova Inc., Arlington,Virginia. L aboratory Report Number: 847624 and CHA Doc. No.: 1105 FLU. Experimental start date June 19, 2003, and completion date September 16, 2003 (p.12). Fin al report issued March 4, 2004. MRID 47090426210

Schneider, M. and M.W. Hatfield. 1989. Flutriafol: Adsorption and desorption equilibria in soil. Unpublished study

performed b y IC I Agrochemicals, Bracknell, Berkshire, England; sponsored b y Imperial Chem ical Industries PL C, location information not reported; and submitted by

Cheminova Inc., Arlington,Virginia. L aboratory Report Number: RJ 0759B and Laboratory

Study No.: 89JH100. Experimental start and completion dates were not reported. Final report is sued November 21, 1989. MRID 47090427 Lane, M.C.G and D. Rowe (p.4). 1991. Flutriafol: effect of time on adsorption properties in soil. Unpublished study

performed and sponsored by I CIAgrochemicals, Jealott’s Hill Research Station, Berkshire, United Kingdom and submitted by Cheminova, Inc., Arlington, Virginia. Report No.: RJ 1057B. Study No.: 91JH115. Experimental initiation and completion dates were not provided. Final report issued December 17, 1991 (p.4)
. MRID 47090428 Adam, D. 2006. [ 14 C]
- Flutriafol: time dependent sorption in four soils. Unpublished study performed b y RCC Ltd, Itingen, Switzerland; and sponsored and submitted by Cheminova A/S, Lemvig, Denmark. RCC Study Number: A38553 and CHA Document Number: 1371 FLU. Experimental start date November 16, 2005, and completion date November 6, 2006 (p. 13). Final report issued December 6, 2006. MRID 47345401 Bioconcentration in Fish Hamer, M.J. and I.R. Hill. 1982. PP450: Accumulation in bluegill sunfish in a flow
- through sy stem. Unpublished study performed and sponsored by Imperial Chemical Industries PLC, Berkshire, United Kingdom; and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: RJ 0286B. CHA Document No.: 427 FLU. Experimental start and completion dates were not reported. Final report issued November 5, 1982
. MRID 47090437 Terrestrial Field Dissipation Harvey , B. et al . 1987 . Flutriafol: fate of radiolabelled material under field conditions. Unpublished study

performed by

I CIPlant Protection Division Jealott's Hill Research Station, Berkshire, United Kingdom; sponsored by Imperial Chemical Industries PLC; and submitted by Cheminova, Inc., Arlington, Virginia. I CIReport No.: RJ 0524B. Experimental start (initial application) date April 23, 1982 (p. 14); completion date not reported. Final report issued June 23, 1987
. MRID 47090429 Atreya, N.C. 1991. Flutriafol: Dissipation in soil from studies in Germany (1982
- 1988). Unpublished study

performed by

I CIPlant Protection Division, Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory

Report No.: RJ1081B. CHA Doc No.: 187 FLU. Experiment initiation February 19, 1982 and completion September 21, 1988 (field phase; Tables 1
- 6, pp.12
- 17). Final report issued December 19, 1991. MRID 47090431 Atreya, N.C. and J.P. Dick. 1988. Flutriafol: Dissipation in soil from studies in France (1982
- 1986). Unpublished study performed b y IC I Plant Protection Division, Bracknell, Berkshire, F rance (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia.211

Laboratory

Report No.: M4745B. CHA Doc No.: 188 FLU. Experiment initiation April 6, 1982 and completion August 21, 1986 (field phase; Tables 1
- 3, pp.8
- 9). Final report iss ued July 1, 1988. MRID 47090432 Atreya, N. C. and J. P. Dick. 1988. Flutriafol: Residue levels in soil from annual application to cereals in West Germany (1982
- 1986). Unpublished study performed by

ICIPlant Protection Division, Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: M4747B. Laboratory Study No.: PP450BD04. CHA Doc No.: 199 FLU. Experiment initiation May 14, 1982 and completion June 17, 1986 (field phase; Tables 1
- 6, pp.9
- 14). Final report issued July 1, 1988. MRID 47090433 Atreya, N.C. and G.S. Davy . 1993. Flutriafol: Residue levels in soil from annual application to cereals in France (1982
- 1989). Unpublished study performed b y Zeneca Agrochemicals, Brac knell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, In c., Arlington, Virginia. L aboratory Report No.: TMJ3131B. L aboratory Study No.: PP450BD04. CHA Doc No.: 204 FLU. Experiment initiation May 13, 1982 and completion June 2 8, 1989 (field phase; Tables 1
- 4, pp.11
- 14). Final report issued July 1, 1993
. MRID 47090434 Atreya, N.C. 1991. Flutriafol: Residue levels in soil from annual application to cereals in the United Kingdom (1982
- 1990). Unpublished study performed b y IC I A grochemicals, Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: RJ 1079B. Laboratory Study No.: PP450BD04. CHA Doc No.: 208 FLU. Experiment initiation May 24, 1982 and completion June 27, 1990 (field phase; Tables 1
- 6, pp.1``2
- 17). Final report issued December 19, 1991. MRID 47090435 Atreya, N.C. and D.W. Bewick. 1991. Flutriafol: Dissipation in soil from studies in the United Kingdom (1982
- 1990). Unpublished study pe rformed by

I CIAgrochemicals, Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: RJ 1080B. CHA Doc No.: 185 FLU. Experiment initiation March 26, 1982 and completion August 13, 1990 (field phase; Tables 1
- 3, pp.11
- 12). Final report issued December 19, 1991. MRID 47115502 Non - Guideline Jarvis, T. 2007. Evaluation of flutriafol degradation kinetics from existing soil and water/sediment degradation studies. Unpublished s tudy performed b y Exponent International Ltd., Yorkshire, United Kingdom; sponsored b y Cheminova A/S, Denmark; and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory Project No.: CH12403; Document No.: 1129. Experimental start and completion d ate were not available. Final report submitted March 15, 2007. MRID 47090436212213



### Appendices I, J, K, and L. Direct and Indirect Effects Endangered Species Analysis for Apples and Soybeans The endangered speci es anal ys is appendices can be found on the flutriafol compact disc.214



### APPENDIX M PRZM Input File for Runoff, Erosion, Leaching Assessment MS soybean; 8/9/01 "Yazoo County; MLRA 134; Metfile: W03 940.dvf (old: Met131.met)," *** Record 3: 0.75 0.36 0 25 1 3 *** Record 6
-- ERFLAG 4 *** Record 7: 0.42 0.3 1 10 3 2 356.8 *** Record 8 1 *** Record 9 1 0.2 30 100 3 87 84 87 0 76 *** Record 9a
- e 1 27 1604 2004 0105 0505 1605 0106 1606 0107 1607 0108 1608 0109 1609 0110 1510 1610 .498 .575 .627 .654 .620 .484 .361 .220 .094 .109 .110 .046 .053 .040 .203 .23 9 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 84 84 84 84 84 84 84 84 84 84 84 84 84 84 87 87 0111 1611 0112 1612 0101 1601 0102 1602 0103 1603 0104 .316 .394 .464 .524 .245 .276 .306 .337 .373 .418 .468 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 87 87 87 87 87 87 87 87 87 87 87 *** Record 10
-- NCPDS, the number of cropping periods 30 *** Record 11 160461 010961 101061 1 160462 010 962 101062 1 160463 010963 101063 1 160464 010964 101064 1 160465 010965 101065 1 160466 010966 101066 1 160467 010967 101067 1 160468 010968 101068 1 160469 010969 101069 1 160 470 010970 101070 1 160471 010971 101071 1 160472 010972 101072 1 160473 010973 101073 1 160474 010974 101074 1 160475 010975 101075 1 160476 010976 101076 1 160477 010977 101077 1 160478 010978 101078 1 160479 010979 101079 1 160480 010980 101080 1 160481 010981 101081 1 160482 010982 101082 1 160483 010983 101083 1 160484 010984 101084 1 160485 010985 1010 85 1 160486 010986 101086 1 160487 010987 101087 1 160488 010988 101088 1 160489 010989 101089 1 160490 010990 101090 1 *** Record 12
-- PTITLE Flutriafol
- 3 applications @ 0.0672 0.0672 0.0672 kg/ha *** Record 13 90 1 0 0 *** Record 15
-- PSTNAM Flutriafol *** Record 16 010661 0 2 0.00.0672 .95 .05 150661 0 2 0.00.0672 .95 .05 290661 0 2 0.00.0672 .95 .05 010662 0 2 0.00.0672 .95 . 05 150662 0 2 0.00.0672 .95 .05 290662 0 2 0.00.0672 .95 .05215

010663 0 2 0.00.0672 .95 .05 150663 0 2 0.00.0672 .95 .05 290663 0 2 0.00.0672 .95 .05 010664 0 2 0.00.0672 .95 .05 150664 0 2 0.00.0672 .95 .05 290664 0 2 0.00.0672 .95 .05 010665 0 2 0.00.0672 .95 .05 150665 0 2 0.00.0672 .95 .05 290665 0 2 0.00.0672 .95 .05 010666 0 2 0.00.0672 .95 .05 150666 0 2 0.00.0672 .95 .05 290666 0 2 0.00.0672 .95 .05 010667 0 2 0.00 .0672 .95 .05 150667 0 2 0.00.0672 .95 .05 290667 0 2 0.00.0672 .95 .05 010668 0 2 0.00.0672 .95 .05 150668 0 2 0.00.0672 .95 .05 290668 0 2 0.00.0672 .95 .05 010669 0 2 0.00.0672 .95 .05 150669 0 2 0.00.0672 .95 .05 290669 0 2 0.00.0672 .95 .05 010670 0 2 0.00.0672 .95 .05 150670 0 2 0.00.0672 .95 .05 290670 0 2 0.00.0672 .95 .05 010671 0 2 0.00.0672 .95 .05 150671 0 2 0.00.0672 .95 .05 290671 0 2 0.00.0672 .95 .05 0106 72 0 2 0.00.0672 .95 .05 150672 0 2 0.00.0672 .95 .05 290672 0 2 0.00.0672 .95 .05 010673 0 2 0.00.0672 .95 .05 150673 0 2 0.00.0672 .95 .05 290673 0 2 0.00.0672 .95 .05 010674 0 2 0.00.0672 .95 .05 150674 0 2 0. 00.0672 .95 .05 290674 0 2 0.00.0672 .95 .05 010675 0 2 0.00.0672 .95 .05 150675 0 2 0.00.0672 .95 .05 290675 0 2 0.00.0672 .95 .05 010676 0 2 0.00.0672 .95 .05 150676 0 2 0.00.0672 .95 .05 290676 0 2 0.00.0672 .9 5 .05 010677 0 2 0.00.0672 .95 .05 150677 0 2 0.00.0672 .95 .05 290677 0 2 0.00.0672 .95 .05 010678 0 2 0.00.0672 .95 .05 150678 0 2 0.00.0672 .95 .05 290678 0 2 0.00.0672 .95 .05 010679 0 2 0.00.0672 .95 .05 15 0679 0 2 0.00.0672 .95 .05 290679 0 2 0.00.0672 .95 .05 010680 0 2 0.00.0672 .95 .05 150680 0 2 0.00.0672 .95 .05 290680 0 2 0.00.0672 .95 .05 010681 0 2 0.00.0672 .95 .05 150681 0 2 0.00.0672 .95 .05 290681 0 2 0.00.0672 .95 .05 010682 0 2 0.00.0672 .95 .05 150682 0 2 0.00.0672 .95 .05 290682 0 2 0.00.0672 .95 .05 010683 0 2 0.00.0672 .95 .05 150683 0 2 0.00.0672 .95 .05 290683 0 2 0.00.0672 .95 .05 010684 0 2 0.00.0672 .95 .05 150684 0 2 0.00.0672 .95 .05 290684 0 2 0.00.0672 .95 .05 010685 0 2 0.00.0672 .95 .05 150685 0 2 0.00.0672 .95 .05 290685 0 2 0.00.0672 .95 .05 010686 0 2 0.00.0672 .95 .05 150686 0 2 0.00.0672 .95 .05 290686 0 2 0.00.0672 .95 .05 010687 0 2 0.00.0672 .95 .05 150687 0 2 0.00.0672 .95 .05 290687 0 2 0.00.0672 .95 .05216

010688 0 2 0.00.0672 .95 .05 150688 0 2 0.00.0672 .95 .05 290688 0 2 0.00.0672 .95 .05 010689 0 2 0.00.0672 .95 .05 150689 0 2 0.00.0672 .95 .05 290689 0 2 0.00.0672 .95 .05 010690 0 2 0.00.0672 .95 .05 150690 0 2 0.00.0672 .95 .05 290690 0 2 0.00.0672 .95 .05 *** Record 17 0 1 0 *** Record 18 0 0 0.5 *** Record 19
-- STITLE Loring Silt Loam; HYDG: C *** Record 20 155 0 0 1 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 30 4 3 17 *** Record 33 6 1 13 1.4 0.385 0 0 0 0.0002130.000213 0 0.1 0.385 0.151 1.28 0 2 23 1.4 0.37 0 0 0 0.0002130.000213 0 1 0.37 0.146 0.49 0 3 33 1.4 0.37 0 0 0 0.0002130.000213 0 3 0.37 0.146 0.16 0 4 30 1.45 0.34 0 0 0 0.00 02130.000213 0 5 0.34 0.125 0.12 0 5 23 1.49 0.335 0 0 0 0.0002130.000213 0 1 0.335 0.137 0.07 0 6 33 1.51 0.343 0 0 0 0.0002130.000213 0 3 0.343 0.147 0.06 0 ***Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1
----- 7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 IN FL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5
PRZM INPUT FILE FOR SOIL ACCUMULATION ASSESSMENT All values are the same as above, except for the last 7 lines: TCON TAVE 1 100 RUNF TCUM 0 0 IN FL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5