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# Preliminary Environmental Fate and Ecological Risk Assessment for the Registration Review of Flufenacet

(4' – fluoro – N – isopropyl – 2 - [5 - (trifluoromethyl) - 1,3,4 – thiadiazol – 2 -yloxy] acetanilide Flufenacet (CAS 142459-58-3)



### P

repared by: Geoffrey Sinclair, Biologist Gabe Rothman, Environmental Scientist U. S. Environmental Protection Agency Office of Pesticide Programs

E nvironmental Fate and Effects Division

E nvironmental Risk Branch V 1200 Pennsylvania Ave., NW

M

ail Code 7507P Washington, DC 20460 R eviewed by: Mah Shamim, Branch Chief

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### Table of Contents

1. Executive Summary ............................................................................................................. ... 4

2. Use Characterization .......................................................................................................... ..... 6

3. Exposure Characterization ..................................................................................................... . 6

3.1 Environmental Fate and Transport Summary .................................................................. 6

3.2 Exposure Pathways .......................................................................................................... 8

3.3 Aquatic Exposure Analysis ............................................................................................ 10

3.4 Terrestrial Exposure Analysis ........................................................................................ 14

4. Ecological Effects Characterization ...................................................................................... 21

4.1 Aquatic Effects Summary .............................................................................................. 21

4.2 Terrestrial Effects Summary .......................................................................................... 25

4.3 Degradate toxicity .......................................................................................................... 2 8

4.4 ECOTOX Open Literature ............................................................................................. 31

4.5 Review of Incident Data ................................................................................................. 31

5. Risk Characterization ......................................................................................................... ... 32

5.1. Risk Estimation .............................................................................................................. 33

5.2. Risk Description ............................................................................................................. 42

5.2.1 Risk to Non-Target Aquatic Organisms ..................................................................... 42

5.2.2 Risk to Non-Target Terrestrial Organisms ................................................................. 47

5.2.3 Uncertainties, Assumptions, and Limitations ............................................................. 55

6. Endocrine Disruptor Screening Program .............................................................................. 57

7. Federally Threatened and Endangered (Listed) Species of Concern .................................... 58

Conclusions ................................................................................................................... ................ 60

8. References .................................................................................................................... ......... 63 Appendix A. Environmental Fate and Ec ological Effects Data for Flufenacet ........................... 65 Appendix B. Status of Environmental Fate a nd Ecological Effects Studies for Flufenacet ........ 80 Appendix C. Formation and Declin e of Flufenacet Metabolites ................................................. 84 Appendix D. Sample SWCC and PRZM-GW Files .................................................................. 104 Appendix E. Sample TREX Files .............................................................................................. 1 08 Appendix F. Sample KABAM Files .......................................................................................... 112 Appendix G. Risk Quotient Method .......................................................................................... 11 7

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# 1. Executive Summary

Scope and Rationale for Registra tion Review Risk Assessment

This document contains the environmental fate a nd ecological risk assessments for the registered

uses of the chemical flufenacet. This risk assessm ent is intended to address the potential ecological risks associated with the registered uses of fluf enacet and is intended to update but not replicate previous assessments. Previous assessments are discussed in the flufenacet problem formulation (DP D382416).

Since these assessments, no new environmental fate data has been submitted that would impact the ecological risk assessment. However, this assessment evaluates ex posure from both parent flufenacet and its thiadone degradate (hereafter thia done) in aquatic environments for the first time. Thiadone forms in water at levels up to 84.3 percent of applied 55 days after application. Refer to

Section 4.3 for further justification.

Six new ecological toxicity studies have been submitted in response to the data requested during the problem formulation stage including parent fl ufenacet chronic toxicity to sheepshead minnow (MRID No. 49244201), acute toxicity to mysid shri mp (MRID No. 49119001), chronic toxicity to mysid shrimp (MRID No. 49119002), acute toxicity to a passerine species (MRID No. 49244202), and mallard duck (MRID No. 44246801). Furthermore, new toxicity data for vascular aquatic plant (Duckweed) and non-vascular plant Selenastrum capricornutum were submitted for the flufenacet thiadone degradate (MRID No. 48897612 and 45796115 respectively). While these

studies have been reviewed and considered in th is risk assessment, ther e are also seven studies submitted currently being reviewed which examine th e toxicity of flufenacet in its form with coformulated products on both vegetative vigor (Guideline number 850.4150) and seedling emergence (Guideline number 850.4100) of terrestr ial plant species. Th ese studies examine Flufenacet SC500 (MRIDs 48897605 and 48897609), Fluf enacet & Isoxaflutole WG 58 (MRIDs 48897606 and 48897610), Flufenacet and Isoxaflutole SC 48 0 (MRIDs 48897607 and 48897611), and Axiom 68DF (MRID 48897688) products. Due to tim e constraints, these studies are still being reviewed and have not been considered in this risk assessment as of this time, but will be in the

future.

Flufenacet Current Registered Uses

Flufenacet is a pre-emergent herbicide and is ap plied as a broadcast surface spray, banded surface spray, or is incorporated into soil for all uses. Current labels allow the use of flufenacet on corn for silage, sweet corn, field co rn, grasses grown for seed, soyb eans, triticale and wheat. The maximum labeled single application rate for flufen acet is 0.8019 lbs a.i./A for corn for silage, field corn, and sweet corn, 0.4420 lbs a.i. /A for grasses grown for seed, 0.4644 lbs. a.i./A for soybeans, and 0.3400 lbs a.i./A for both triticale and wheat, w ith maximum crop cycle applications specified

the same for each use.

Flufenacet belongs to a class of compounds called the oxyacetamides that act by inhibiting mitosis and cell division ( http://www.plantprotec tion.org/hrac/MOA.html ). Like other acetamide

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### herbicides, flufenacet inhibits root and shoot grow th of germinating seeds and very small emerged seedlings.

Environmental Fate and Exposure Summary

Flufenacet residues have the ability to reach nearby water bodies equivalently in a dissolved state

via runoff and sorbed state via erosion based on its soil organic carbon – water partition coefficient 209 – 762 mL/g and solubility value of 56 mg/L. The primary degradation of flufenacet occurs with biodegradation in aerobic soil and aerobic water envir onments via cleavage of the ether linkage (see Figures 1 and 2 ). It is moderately persistent in both soil and water environments with half-lives ranging between 23.1 – 63.6 days in aerobic soil e nvironments and 18 – 77 days in aerobic aquatic environments. The toxic degr adate of concern, the thiadone degradate of flufenacet, forms in water bodies at levels of up to 84.3 percent of applied wh ere it is persistent with half-lives ranging between 160 – 303 days in aerobic and an aerobic environments. Thiadone more readily biodegrades in top soil with half -lives ranging between 2.0 – 2.8 days in aerobic environments, and therefore is not likely to be av ailable for runoff in large quantities as compared to quantities at which it is obser ved to form in water bodies.

While flufenacet is applied prior to the emergen ce of crops, exposure to flufenacet residues is possible for terrestrial organisms. Insectivores and granivores may inge st food items on fields

treated with flufenacet residues. Exposure is further plausibl e given flufenacet’s moderate persistence in terrestrial e nvironments (half-lives rangi ng between 23.1 – 63.6 days).

Ecological Effects Summary and Risk Conclusions

When estimates of flufenacet expos ure in terrestrial and aquatic environments are compared to the available ecotoxicity data, the results of the scr eening-level assessment indicate a potential for risk above the level of concern to both aquatic and terre strial taxa for proposed uses of flufenacet.

Refer to Table 30 and Table 31 in the Conclusions Section of this document ( Section 5) which present the risks of concerns f ound for all aquatic and terrestrial organisms, respectively, resulting from the proposed uses of flufenacet specified by crop.

Flufenacet is moderately toxic to aquatic animals (invertebrates an d fish). In general, risk quotients for aquatic organisms are calculated cons idering a single total t oxic residue estimated exposure concentration (EEC) incl uding flufenacet and its thiadone degradate in the surface water column for each crop. Risk concerns exist for only a quatic plants for all uses (non-listed and listed RQs ranging between 1.6-60.2) but not for any aquatic animal taxa for all uses. Risks to aquatic plants are predominantly driven by runoff as opposed to spray drift as risk conclusions largely do not change when removing the contribution of spray drift. Given the risks identified for aquatic plants, separate EECs of flufenacet and thiadone ar e presented. Overall, risks remain to aquatic plants upon further examination when separating the EECs (see Section 5.1 and Table 17 for further explanation).

For terrestrial wildlife, flufenacet is slightly toxic to mammals on an acute basis, slightly to highly toxic to birds on an acute basis, practically non-tox ic to terrestrial invertebrates on an acute contact basis. Since the time of the problem formulation, the Agency now also requires acute and chronic

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### toxicity studies submitted for larval bees and chronic feeding studies for adult bees. While flufenacet was classified as practically non-toxi c to honey bees on an acute contact basis, the impacts of flufenacet on chronic exposure to adu lts or on the biology of larvae currently constitute an uncertainty in this assessment.

Acute avian risk to threatened and endangered birds was identifie d for every use of flufenacet (RQs as high as 0.41) and chronic avian risk was identified for every use except wheat and triticale (RQs as high as 2.19). Acute risk to endangered mammals was identified for corn uses (RQs as high as 0.14) while chronic mammalian risk was identi fied for every use (RQs as high as 7.3). The most direct risks to animals and birds with pre- emergent flufenacet applications may occur due to ingestion of arthropods and seeds containing applied fluf enacet residues on the field. However, risks may also occur with short grass and non-cr op broadleaf plants off the treated field given

runoff of flufenacet residues from the treated field. The extent of exposure under the runoff scenario is uncertain given the nature of terrestri al exposure estimates available on the treated field only.

Larger risk concerns associated with flufenacet uses are identified with terrestrial plants. Terrestrial plant risk was identifi ed for every use of flufenacet (non-listed and listed RQs ranging between 0.2–25.5), and both runoff and spray drift proc esses contribute to the overall risk. Buffers required to mitigate the spray drift to terrestrial plants ranged from 3 feet to 988 feet depending on application method and application rate (Tables 26 – 29)

.



# 2. Use Characterization

Current labels allow the usage of flufenacet on co rn for silage, sweet corn, field corn, grasses grown for seed, soybeans, triticale and wheat. Flufenacet maximum ap plication rates are 0.8019 lbs a.i./A for corn for silage, field corn, and sw eet corn, , 0.442 lbs a.i./A for grasses grown for seed, 0.4644 lbs. a.i./A for soybeans, and 0.34 lbs a.i./A for both triticale and wheat. These maximum application rates are specified as a single or crop-cycle basis. Flufenacet is only used as a pre-emergent herbicide and is applied as a broadcast surface spray, banded surface spray, or via soil incorporated methods for all uses.

The screening-level use assessment (SLUA) estimate s of agricultural uses of flufenacet indicate that usage on corn alone accoun ts for roughly 88% of the tota l use (USEPA 2010). Usage of flufenacet is applied on at most 5% of the total crop area treated for agricultural uses. Flufenacet usage is concentrated in the corn and soybean belt of the Midwest, North Carolina, Southern High Plains, and Oregon.



# 3. Exposure Characterization

3.1 Environmental Fate and Transport Summary

This document presents a summary on the fate a nd transport behavior for both flufenacet and its thiadone degradate in the environm ent given that there is a comple te dataset of fate studies for

both constituents. Section 3.C of the original problem form ulation document (DP Barcode: D382416; EPA 2011) can be referred to for further details. No new envi ronmental fate studies

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### have been submitted since the original problem fo rmulation with the exception of environmental chemistry methods (ECMs) and independent laborat ory validations (ILVs) in soil and water for flufenacet and its thiadone, alcohol, oxalate, and sulfonic acid degradates. The table summarizing the quality classifications for each study is provided in Appendix B

.

Flufenacet can exist both in the di ssolved phase and sorbed phase in soil at equivalent levels, with

K oc 

### values ranging from 209 – 762 mL/g oc 

### (MRID No. 43441137) and aqueous solubility value of 56 mg/L. Therefore, flufenacet has th e ability to reach ground water via leaching processes and aquatic environments via runoff and erosion processes. Flufenacet will not likely predominately exist in the vapor-phase given its vapor pr essure of 2.11 x 10 -7 

### torr and Henry’s

Law Constant of 2.12 x 10 -8 

### atm•m 3 

### /mol.

Flufenacet is moderately persistent in soil a nd water with primary decline occurring due to biodegradation in aerobic environments over time. Flufenacet half-lives range from 23.1 days – 63.6 days in aerobic soil environments (MRID Nos. 43441141, 43441135, and 43850058) and 18 – 77 days in aerobic aquatic environments (MRID Nos. 45796112 and 44580203). Flufenacet is stable in anaerobic soil environments (MRID No. 43850059) and persistent in anaerobic aquatic systems with a half-life of 492 days (MRID No. 43850060). Flufenacet is stable due to abiotic degradation processes includi ng hydrolysis and photolysis in water and soil (MRID Nos. 43441134, 43850056, and 43850057). The overall moderate persistence of flufenacet in the

environment is verified from field di ssipation studies (MRID Nos. 43850062,43850063). The

molecular structure of fl ufenacet is shown in in Figure 1 below.

Figure 1. Molecular structure for flufenacet.

In general, flufenacet breaks down in both soil a nd water by separating into anilide and thiadone components via cleavage of the ether linkage (MRID Nos. 43441141, 43441135, 43850058, 45796112, 44580203). The entire thiadone group (right hand side of the parent molecule in Figure 1) remains completely intact and is persistent in aerobic and anaerobic aqua tic environments with half-lives ranging betw een 160 - 303 days (MRID Nos. 4579110 and 45796111), but is more labile

in aerobic soil environments w ith half-lives ranging 2.0 – 2.8 days (MRID No. 45796109). In both soil and water, the anilide group (left hand side of the parent molecule) exhibits more complex serial degradation processes to alcohol, methyl sulfoxide, oxylate, and sulfonic acid by-products. The anilide by-products described above are all detect ed at major levels (greater than 10 percent of applied) in the aerobic soil, anaerobic soil, aerobic aquatic, and an aerobic aquatic metabolism laboratory studies (MRID No s. 43441141, 43441135, 43850058, 45796112, and 44580203). However, the thiadone degradate is only detected at major levels in water likely given its high persistence in aerobic and anaerobic aquatic environments and more labile nature in aerobic soil environments (MRID Nos. 43441141, 43441135, 43850058, 45796112, 44580203, 4579110, 45796111, and 45796109). Refer to Tables C-1 and C-2 in Appendix C for detailed information

on the formation and decline for all of the degradates in soil and water.

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### Both the thiadone degradate and flufenacet have been identified as the residue s of concern in this ecological risk assessment (see Section 4.3 for a complete discussion). Given thiadone’s highly labile nature in soil, substant ial translocation of the thiadone degradate via leaching to ground water and runoff to aquatic environments is not likely. However, the thiadone degradate is expected to form at high levels from biod egradation of flufenacet residues which reach

surface water. Once the thiadone degradate forms, it is li kely to be persistent in water for a long duration as indicated by its ha lf-life of 160 – 303 days in aerobic and anaerobic aquatic environments. It should be noted that as compared to flufenacet, a more substantial portion of the thiadone degradate material would likely remain in the water column ra ther than sorbed to sediment given its K oc 

### values in the rang e of 29 – 58 (MRID N o. 43441140). The thiadone degradate in water is not anticipated to exist in the vapor-phase at large levels given its Henry’s

Law Constant of 1.2 x 10 -7 

### atm•m 3 

### /mol. The molecular structure of the thiadone degradate is

shown in Figure 2

.

Figure 2. Molecular structure for the flufenacet thiadone degradate.



## 3.2 Exposure Pathways

Flufenacet and its thiadone degradate are cons idered to be the primary stressors for aquatic organisms in this risk assessment. In aquatic environments, the thiadone degradate is formed at major levels in aerobic water envi ronments of up to 84.3% of applie d 55 days after application due to cleavage of the parent flufenacet molecule as a result of biodegradation in aerobic environments. Since the thiadone degradate is generally more m obile than the parent, the environmental fate characteristics specific to flufenacet and thiadone w ill be incorporated separately into the aquatic exposure analysis using formation-decline appr oach. In this approach, the total residue concentration that is predicted reflects the declin e of the parent and the subsequent formation and decline of the degradate as stipulat ed by their unique fate properties. It should be noted that while the unique fate characteristics of thiadone will be considered separately in aquatic exposure estimation, aquatic EECs will initially be presented as a total toxi c residue, and refined if risk is

indicated to show fluefenacet and thiadone specific EECs. Refer to Section 3.1 in this document

or Section 3.C in the problem formulation for a further de scription of the behavior of the thiadone degradate in the environment. . Furthermore, refer to Appendix C on the formation of thiadone and other major degradates., and Table 13 of Section 4.3 supporting the findings on the expected relative toxicity of the thiadone degradate and all other major degradates to parent flufenacet. In the terrestrial environment, only parent fluf enacet is considered the primary stressor for terrestrial organisms since thiadone does not form at major levels in soil

The identification of relevant environmental exposu re pathways to flufenacet applications for this

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### risk assessment evaluating impact to non-target or ganisms are further discussed in detail below:

 Aquatic Exposure : Flufenacet’s potential to be tran sported to water bodies and aquatic

habitats in both a dissolved state in runoff or sorb ed state to erodible soil particles is a relevant pathway associated with flufenacet applications. The moderate persistence of flufenacet in the environment lends itself to being available to runoff and erosion off-site transport processes. Furthermore, off-site spray drif t deposition of flufenacet to water bodies nearby applications may also adversel y impact aquatic organisms. In addition, once flufenacet reaches a water body, there is the potential for its thiadone degradate to form. Freshwater and estuarine marine fish and invertebrates as well as aquatic plants in the water column may be impacted. Limited exposure is expected occur with benthic and sediment-dwelling organisms given flufenacet is not expected to build up in sediment and organic matter given

its measured K oc 

### in the range between 209 – 762 mL/g and log K ow 

### of 3.2. Refer to the problem formulation document for furt her details (DP Barcode: D382416; EPA 2011).

 Dietary Exposure : Direct dietary exposure to non-targ et terrestrial organisms (birds and mammals) is possible with the application of fl ufenacet. While flufenacet is applied prior to the emergence of crops, insectivores and gr anivores may ingest food items possessing the flufenacet residues. Dietary exposure is also possible given the moderate persistence of

flufenacet in the terre strial environment.

Furthermore, indirect dietary exposure may resu lt from aquatic exposure to fish (discussed above). Therefore, piscivor ous birds and mammals feeding on contaminated fish may potentially be exposed. Bioaccumulation potentia l of flufenacet residues is possible in fish given flufenacet’s moderately high Log K ow 

### value of 3.20 and moderately high steady-state BCF values in fish of up to 103X (MRID Nos. 43441127 and 43441139).

 Terrestrial plants: Given the herbicidal characteristics of flufenacet, adverse impacts to non-target terrestrial plants ar e expected. Exposure may occur via the runoff of residues offsite from treated fields to adjacent lands cove red with non-targeted ve getation. Furthermore, off-site deposition of flufenacet due to spray drift may also adversely impact non-target terrestrial plants. Another potenti al route of exposure that exists to terrestrial plants includes application of irrigation water to non-target plants and crops from ground and surface water sources possessing flufenacet residues. This is possible given its moderate persistence in the environment and ability to move to surface water via runoff and ground water via leaching.

 Terrestrial invertebrates: Dietary and contact exposure to terrestrial invertebrates are possible pathways with flufenacet applications. Crops on fields pre-treated with flufenacet may potentially uptake flufenacet residues. Crops containing flufenacet residues may potentially attract terrestrial in vertebrates (e.g., benefi cial insects) resulting in dietary and

contact exposure.

Drinking water and inhalation exposure to t errestrial animals are not expected to be of

concern as verified by results of the Screening Imbibition Program (SIP version 1.0, 6/15/2010) and the Screening Tool for Inhalation Risk (STI R version 1.0; 11/23/2010), respectively. SIP is available publically a t: http://www.epa.gov/oppefed1/models /terrestrial/sip/sip_user_guide.html.

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### STIR may be accessed on-line at: http://www.epa.gov/oppefed1/models/terrestrial/stir /stir_user_guide.html. The analyses using SIP and STIR are presented in the problem formulation document (DP Barcode: D382416; EPA 2011).

Risk hypotheses are specific assumptions about potential a dverse effects ( i.e. , changes in assessment endpoints) and may be based on theory a nd logic, empirical data, mathematical models, or probability models (EPA 1998). For flufenac et, the following ecological risk hypothesis is being employed for this risk assessment:

Given the proposed ground and aeri al foliar spray uses of fluf enacet and its environmental fate properties, there is a likelihood of expos ure with flufenacet and its thiadone degradate to non-target aquatic organisms, and with flu fenacet alone for terrestrial organsims.

When used in accordance with th e label, flufenacet results in potential adverse effects upon the survival, growth, and reproduction of non- target terrestrial and aquatic organisms.



## 3.3 Aquatic Exposure Analysis

Aquatic Exposure Estimation Modeling

Estimated exposure concentrations for aquatic an imals and plants in su rface waters for labeled flufenacet applications are estimated using The Surface Water Concentrati on Calculator interface (SWCC version 1.21, dated February 19, 2015). Comb ined exposures from parent flufenacet and its thiadone degradate are pres ented using the formation-decline method accounting for the presence of both compounds simultaneously in th e environment over time. The formation-decline method is selected for this analysis since thiadone is more mobile than parent flufenacet. Refer to beginning of Section 3.2 for further information on the form ation-decline method. The SWCC is

available on-line at: http://www.epa.gov/oppefed1/models/water/#swcc

.

In this assessment, exposure estim ates for each of the current cr op uses presente d represent the highest and most vulnerable exposure for flufenacet use sites across the c ountry which its used including the Midwestern Corn Be lt, Southern Plains, North Carolin a, and Oregon. For all of the agricultural crop uses, broadcast su rface spray applications to bare ground are evaluated since this is the conservative application scenario for runoff. The fate parameters and use-specific input parameters for the SWCC surface water modeling are shown in Table 1 and Table 2, respectively. The EECs of flufenacet and its thiadone degradat e in surface water are shown for aerial and ground applications in Table 3 . The SWCC output f iles are provided in Appendix C

.

Table 1. SWCC input parameter values used for su rface water aquatic exposure estimation with flufenacet and its thidadone degradate. SWCC Input Parameter Input Value and Unit (Flufenacet/Thiadone Degradate) Source

Physical Chemical Properties Molecular Weight (g/mol) 363/170 MRID 43441102 and 43850001

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### Table 1. SWCC input parameter values used for su rface water aquatic exposure estimation with flufenacet and its thidadone degradate. SWCC Input Parameter Input Value and Unit (Flufenacet/Thiadone Degradate) Source

Vapor Pressure (torr) 2.40 x 10 -11 

### /1.5x10 -2 MRID 43441102 and 43850001 

### Solubility in Water (mg/L) 56/200,000 MRID 43441102 and 43850001 

### Soil-Water Partition Coefficient (K oc 

### ) (mL/g) 434.4/43.5 Average values

MRID 43441137 and 43441140



### Environmental Fate Properties Hydrolysis at pH7 (t 1/2 

### ) Stable/Stable MRID 43441134 and 45796107



### Aerobic soil metabolism (t 1/2 

### ), Reference Temperature, and Degradate Molar Formation Fraction 48.2 days at 25°C/ 2.77 days at 25°C

Deg. Molar Formation

Frac.:1.0 2 MRID 43441141, 43441135, 43850058, & 48604493

Upper 90 TH percent confidence

interval 1



### Aerobic aquatic metabolism (t 1/2 

### ), Reference Temperature, and Degradate Molar Formation Fraction 77.1 days at 25°C/160 days at

25°C

Deg. Molar Formation

Frac.:1.0 2 MRID 45796112, 44580203, &

45796111

Upper 90 TH percent confidence

interval 1



### Anaerobic aquatic metabolism (t 1/2 

### ) and Reference Temperature 492 days at 25°C /303 days at

25°C

Deg. Molar Formation

Frac.:1.0 2 MRID 43850060, 43850061, &

45796110

Upper 90 th percent confidence

interval 1



### Aqueous Photolysis (t 1/2 

### ) and

Reference latitude Stable at 45°N/Stable at 45°N MRID 43850056 and 46997401

1 The upper 90 th percent confidence bount half-life calculated as follows: t 1/2 input = ݐ ଵ/ଶ ത ത ത ത ത

+ (t 90, n-1 x σ )

n 1/2

where ݐ ଵ/ଶ ത ത ത ത ത

is the mean of the set of half lives from each study, t 90, n-1 is the one-sided t value for the 90 th percent
confidence bound, σ is the standard deviation of the set of half- lives determined from each study, and n is the sample size of the set of half-l ives determined from each study.

2 A value of 1 is selected based on a one-to-one stoichiometric relationship in the formation pathway of thiadone from parent flufenacet.Page 12 of 1181Crop scenarios presented highest exposure and most vulnerable scenario for all flufenacet uses confined to the Midwest, North Carolina, Southern HighPlains, and Oregon.2Maximum single application rate specified on product labels.3Specified on product labels.4The most conservative application method evaluated based on crop uses specified on product labels.5EFED input parameter guidance for aerial and ground applications.6Spray drift fraction for aerial and ground applications from Table 2 of EPA, 2013, “Guidance on Modeling Offsite Deposition ofPesticides via Spray Drift”.Table 2. SWCC crop scenario and application methods input parametervalues for flufenacet aquatic exposure estimation.Crop UseSWCC Application Method and Crop Scenario Input ParametersSWCC Scenario andWeather Station1ApplicationRate(kg a.i./ha)2Number ofApplicationsandRetreatmentInterval2ApplicationTimeWindow3ApplicationMethods4ApplicationEfficiency5Spray DriftFraction6Corn(Sweet, Field, and Silage)IL Corn14842.dvf(Peoria, IL)0.8981 app.15 daysbefore cropemergenceGroundSpray0.99 0.062Soybeans MI Beans14826.dvf(Flint, MI)0.520Wheat and Triticale ND Wheat14914.dvf(Fargo, ND)0.386Grass Seed OR Grass Seed24232.dvf(Salem, OR)0.495

### Page 13 of 118 

### Table 3. SWCC estimated upper bound concentrations in the

surface water column for flufenacet and flufenacet thiadone total toxic residue at the highest application rate for proposed crop uses (flufenacet equivalent ppb).

Crop Use (SWCC Scenario) Surface Water Column EECs (μg/L)

Peak 21-day 60-day

Corn (IL Corn) 26.5 25.4 23.7

Soybeans (MI Beans) 9.0 8.5 8.3

Wheat and Triticale (ND Wheat) 6.7 6.5 6.3

Grass Seed (OR Grass Seed) 4.5 4.3 4.1

*Bold text indicate maximum values.

1 One-in-ten year estimated value.



### Water Quality Monitoring Data

There are some water monitoring da ta available for flufenacet and it s degradates in surface water, stream water, and ground water from the US GS National Water Quality Assessment (NAWQA) and EPA’s Storage and Retrieval Warehouse (STORET) monitoring da tasets. In general, these monitoring data indicate that the SWCC and PRZM-GW modeling provide reasonably protective estimates of aquatic exposure. In addition, th ere are additional monito ring data in untreated drinking water, finished drinki ng water, as well ground water in the EPA Pesticide Data Program (PDP). With all of these data, it should be no ted that there are no indications whether or not these data represent targeted sampling observations. However, there is also a targeted Prospective Ground Water Study submitted by the registrant for fl ufenacet and its degradates available as well (MRID No. 46997402).

The NAWQA monitoring dataset encompasses 1,860 samp les of parent fluf enacet at various surface water and ground water monitoring sites fo r the period between 2001and 2012. Flufenacet degradates are not known to have been sampled. The nature of detections of flufenacet in the NAWQA data are summarized below:

 Flufenacet was detected in stream water 14 times out of 797 total surf ace water samples at various sites in Iowa, Nebraska, Ohio, Maryla nd, and South Carolina. Concentrations of up to 0.31 ppb were detected in Dodge County, Iowa.

 Flufenacet was detected in wells 3 times out of 895 total ground water samples at various

sites in Iowa and Minnesota. Concentr ations of up to 0.04 ppb in ground water were detected in Buena Vista County, Iowa.

 Flufenacet was detected twice out of 222 tota l samples in stream sediment pore water, both instances in Nebraska, with concentra tions of up to 0.74 ppb detected in Colfax County.

### Page 14 of 118 

###  Flufenacet was detected at once out of 36 to tal samples at a dist ributed drinking water facility in Sandova County, NM at concentrations of up to 0.04 ppb. Details on the exact siting of concentrations within influe nt or finished water was not provided.

An expanse of water monitoring information related to sampling of flufenacet’s oxalate degradate in Minnesota is available from the STORET database. The sampling occurred between the years 2010 – 2013. No detec tions were found out of 2,069 samples.

There is a further expanse of monitoring data available from EPA’s PDP from drinking water facilities and ground water well for flufenacet. Flufenacet was only detected once in finished surface water out of 964 samples. However, the magnitude of detection was really large at 75 ppb. This detection occurred in Indiana in 2007. Flufenacet was not sampled in ground water in

the PDP.

Furthermore, there is a targeted prospective ground water study conducted in six monitoring wells encompassing shallow wells (15 to 25 ft. below ground surface) and deep wells (25 to 30 ft. below ground surface) for flufenacet, and its thiadone degradate (MRID No. 46997402). The monitoring study was conducted concurrent to a pre- emergent application of Flufenacet in a corn field possessing silt loam soil located in the town of Minden in Central Nebraska during June of 1995. The monitoring data with each constituent is described below:

 Flufenacet was only detected one time in a sh allow well at 0.04 ppb within 30 days of the application.

 The thiadone degradate was detected extensivel y but at low levels starting at 119 days after the application in both in shallow a nd deep wells. Concentra tions ranged as high 0.18 ppb at 501 days after the application. The thiadone degradate was not detected after 1,155 days after the application.



## 3.4 Terrestrial Exposure Analysis

Terrestrial wildlife exposure estimates are typi cally calculated for birds and mammals. This assessment focuses on the dietary expos ure route for birds and mammals (see Section 3.2 ). For exposure to terrestrial organisms, such as bi rds and small mammals, pe sticide residues on food items are estimated, based on the assumption that organisms are exposed to a single pesticide residue in a given e xposure scenario.

a. Terrestrial Animal Dietary Exposure Estimation

A primary concern with flufenacet is that bi rds and mammals may be exposed shortly after application through oral or dietary exposure to seeds or insects when foraging in the treated fields for nesting material or food. Therefore estimati on of pesticide concentr ations in wildlife food items focuses on quantifying possible dietary i ngestion of residues on vegetative matter and insects. The EFED terrestrial exposure model T-REX (T-REX, Version 1. 5, released 03/2012) is used to estimate exposures and risks to avian and mammalian species. Input values for avian and

### Page 15 of 118 

### mammalian toxicity as well as chemical appli cation and foliar dissipation half-life data are required to run the model. Th e model provides estimates of e xposure concentrations and risk quotients (RQs). Specifically, the model provid es estimates of concen trations (upper-bound and mean) of chemical residues on the surface of diffe rent types of foliage and insects that may be dietary sources of exposure to avian, mammalia n, reptilian, or terrestrial-phase amphibian receptors. The surface residue concentration (ppm ) is estimated by multiplying the application rate (pounds active ingredient per acre) by a value specific to each food item. These values (termed the Hoerger-Kenaga estimates) along with a more detailed discussion of the methodology implemented by T-REX, are presented in Appendix E (T-REX Model).

Input values used for estimating avian and mamma lian exposure risks to fl ufenacet are summarized

in Table 4

Table 4. Input parameters used in T- REX v 1.2.5 to determine terrestrial EECs for the maximum flufenacet spray application scenarios.

Input Parameters Value Source

Single Application

Rate (lb a.i./A) 

### Corn (sweet and field), soybeans 0.8019

Product

labels



### Soybean 0.4644

Grass Seed 0.442

Wheat, Triticale 0.3448

Foliar Half-life 35 days Default

value 1

Number of Applications (Interval between Applications, days) 

### All flufenacet uses 1 Product

labels

Avian Oral LD 50 461 mg/kg-bw (canary) MRID

49244202

Avian Reproduction

NOEAC 88.0 ppm (mallard) MRID

43441120

Mammal LD 50 589 mg/kg-bw (rat) MRID

43441104

Mammal NOAEC 1.3 mg/kg-diet (rat) MRID

3850033

1 The foliar half-life did not infl uence the prediction of the te rrestrial EECs for flufenacet because only one application of flufenacet is allowed per season, and thus the peak concentration occurs immediately after this single application before any dissipation occurs.



### By comparing estimated exposure concentrations to acute and chronic toxi city reference values, RQs are calculated. The EECs on food items may be co mpared directly with dietary toxicity data or converted to an oral dose, as is done for small mammals. For mammals, the residue

### Page 16 of 118 

### concentration is converted to da ily oral dose based on the fraction of body we ight consumed daily as estimated through mammalian allometric relations hips. The screening-level risk assessment for flufenacet uses upper-bound predicted residues as the measure of exposure. Consideration is given to different types of feeding strategies for mammals, including herbivores, insectivores and granivores. Dose-based exposures are estimated for three weight classes of birds (20 g, 100 g, and 1000 g) and three weight classes of mammals ( 15 g, 35 g, and 1000 g). Summaries of the predicted upper-bound residues of flufenacet that may be exp ected to occur on selected avian or mammalian food items immediately following application for the maximum use scenario are presented in Tables 5, 6, and 7.

For the maximum flufenacet applic ation scenario, concentrations fo r different forage types ranged from 0.8 to 219.2 ppm for upper-bound residues a nd 0.36 to 77.63 ppm for mean residues. Flufenacet concentrations were highest on the su rfaces of short grass and lowest on the seeds.Page 17 of 118Table 5. Avian TREX dose-based EECs (mg/kg).Useandapplicationrate(lbsa.i./A)20g"Small"Bird100gram"Medium"Bird1000gram"Large"Bird

Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods Seeds Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods Seeds Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods SeedsCorn(SweetandField)(0.8019)219.2100.5123.313.785.83.0125.057.370.37.849.01.756.025.631.53.521.90.8Soybean(0.4644)126.958.271.47.949.71.872.433.240.74.528.41.032.414.918.22.012.70.5GrassSeed(0.442)120.855.468.07.647.31.768.931.638.84.327.01.030.814.117.41.912.10.4Wheat,Triticale(0.3448)94.243.253.05.936.91.353.724.630.23.421.00.724.111.013.51.59.40.3Page 18 of 118Table 6. Mammalian TREX dose based EECs (mg/kg).Useandapplicationrate(lbsa.i./A)15gram"Small"Mammal35gram"Medium"Mammal1000gram"Large"Mammal

Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods Seeds Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods Seeds Short Grass Tall Grass Broadleaf Plants Fruits/pods Arthropods SeedsCorn(SweetandField)(0.8019)183.584.1103.211.571.92.5126.858.171.37.949.71.829.413.516.51.811.50.4Soybean(0.4644)106.348.759.86.641.61.573.433.741.34.628.81.017.07.89.61.16.70.2GrassSeed(0.442)101.146.456.96.339.61.469.932.039.34.427.41.016.27.49.11.06.30.2Wheat,Triticale(0.3448)78.936.244.44.930.91.154.525.030.73.421.40.812.65.87.10.85.00.2

### Page 19 of 118 Table 7. TREX dietary-based EECs (mg/kg).

Use and application

rate (lbs a.i./A)Short GrassTall GrassBroadleaf PlantsFruits/podsArthropods



### Corn (Sweet and
Field)
(0.8019) 192 88 108 12 75

Soybean
(0.4644) 111 51 63 7 44

Grass Seed

(0.442) 106 49 60 7 42

Wheat & Triticale
(0.3448) 83 38 47 5 32



### b. Terrestrial Plant Exposure Estimation

There are three routes of exposure to terrestrial plants for flufenacet . Off-site transport via spray drift and runoff are two of these exposure routes. The third is the application of irrigation water to non-target crops and plants potentially contaminated with flufenacet residues.

The TerrPlant model (v. 1.2.2; December 26, 2006) evaluates terrestrial plant exposure contributions from runoff and spray drift. It is used to derive EECs rele vant to terrestrial and wetland plants. The model employs the assumption that default fractions of the intended application are transported to an adjacent fiel d through runoff and spray drift. Measures of exposure to terrestrial plants are expressed as a fraction of the mass of the flufenacet applied to the

treated field. TerrPlant EECs are shown in Table 8 below.

### Page 20 of 118 

### Table 8. TerrPlant EECs (lbs. a.i./A) for fluf enacet exposure to terrestrial and wetland plants resulting from runoff and spray drift.

Use (application rate ‐ lbs a.i./A) Description of Area EEC

(lbs a.i/A)

Corn (Sweet and Field) (0.8019) Runoff to dry areas 

### 0.008

Runoff to semi-aquatic areas 

### 0.080

Spray drift 

### 0.008

Total for dry areas 

### 0.016

Total for semi-aquatic areas 

### 0.088

Soybean
(0.4644) Runoff to dry areas 

### 0.005

Runoff to semi-aquatic areas 

### 0.046

Spray drift 

### 0.005

Total for dry areas 

### 0.009

Total for semi-aquatic areas 

### 0.051

Grass Seed

(0.442) Runoff to dry areas 

### 0.004

Runoff to semi-aquatic areas 

### 0.044

Spray drift 

### 0.004

Total for dry areas 

### 0.009

Total for semi-aquatic areas 

### 0.049

Wheat & Triticale (0.3448) Runoff to dry areas 

### 0.007

Runoff to semi-aquatic areas 

### 0.069

Spray drift 

### 0.003

Total for dry areas 

### 0.010

Total for semi-aquatic areas 

### 0.072



### Potential exposure via flufenacet residues in irrigati on water applied to non-target plants and crops

can be estimated from EECs in surface water a nd ground water. For flufenacet, surface water EECs (including flufenacet and flufenacet thia done) are higher than ground water (refer to Appendix D showing ground water estimation modeling results). Therefore, peak EECs for flufenacet only in the surface water column as presented in Table 17 serves as the preliminary basis for deriving equivalent EECs to plants impact ed via this exposure occu rring associated with irrigation practices. Further anal ysis related to this exposure pathway is provided in the Risk Description Section ( Section 5.2.2 ).

### Page 21 of 118 

### c. Terrestrial Invertebrate Exposure Estimation

Exposure to bees is expected w ith applications thr ough boom spray. Drift fr om the boom sprayers or residues may come into contact with pollinators either through di rect contact or contact with residues. Possible exposures fr om either acute contact or oral exposure to the proposed applications rates were calculated using Bee-Rex modeling. To calculate contact exposure, the application rate was multiplied by 2.7 μg a.i./bee. Oral exposure was calculated by multiplying the application rate by ((110 μg a.i./g)*0.292g/day)). For details see the Guidance for Assessing Pesticide Risks to Bees (USE PA, 2014). Estimated dose expos ure concentrations for honeybee contact and oral exposure is presented in Table 9 resulting from each flufenacet use.

Table 9. Flufenacet contact and oral estimated exposure dose concentrations to honeybees.

Use (Application Rate ‐ lbs a.i./A) Contact Exposure (mg/kg) Oral Exposure (mg/kg)

Corn (Sweet and Field)
(0.8019) 

### 2.17 25.76

Soybean
(0.4644) 

### 1.24 14.78

Grass Seed

(0.442) 

### 1.19 14.20

Wheat & Triticale
(0.3448) 

### 0.93 11.06



# 4. Ecological Effects Characterization

The ecological effects characteri zation for flufenacet is based upon registrant-submitted toxicity data for the TGAI (parent flufenacet ) and for specified formulations.



## 4.1 Aquatic Effects Summary

Flufenacet exposure effects on aquatic organisms were determined by assessing freshwater and estuarine/marine taxa. Five new studies (a ch ronic toxicity test w ith the sheepshead minnow (MRID 49244201), an acute and a chronic toxicity test with the mysid shrimp (MRIDs 49119001 and 49119002), and degradate toxicity tests with the fresh water vascular plant Lemna gibba (MRID 48897612) and the non-vascular plant Selenastrum capricornutum (MRID 45796115)

have been submitted and reviewed since the time of the last assessment. These studies are summarized below. The most sensitive endpoints for the remaining taxa that will be used in this risk assessment are presented in Table 10. Refer to the 2010 assessment for more comprehensive descriptions of the studies.

Chronic Toxicity to Sheepshead minnow (Cyprinodon variegatus )

### Page 22 of 118 

### The 35-day chronic toxicity of flufenacet to the early life-stage of sheepshead minnow ( Cyprinodon variegatus ) was studied under flow-through conditions (MRID 49244201). Meanmeasured treatment concentrations were <4.0 (<LOQ, control), 49, 95, 174, 339 and 677 μ g ai/L.

No treatment-related effect on survival was indicated at any level: surviv al (Day 6) ranged from 87.9 to 90.7% for all levels and fry survival (D ay 35) ranged from 95.0 to 98.8%. No treatmentrelated effect on time to hatch was observed. On Days 5 and 6, percent hatch for all levels ranged from 29.3 to 39.3% and 84.3 to 89.3%, respectively, no statistically-significant differences from

the control were found. At the 677 μ g ai/L level, fish were observe d to be swimming at the bottom of the test vessel, except when being fed, beginning on Day 32. Gr owth (at study termination) was the most sensitive endpoint. For both growth parame ters, differences were statistically-significant compared to the control (p=0.05) at the ≥ 95 μ g ai/L levels. Reductions in length were observed to be 4%, 4%, and 7% while reductio ns in weight were observed to by 6%, 9%, and 19% in the 174,

339 and 677 μ g ai/L treatment levels respectively. The overall NOAEC an d LOAEC were 49 and

95 μ g ai/L, respectively, based upon a treatment-related reduction in standard length and dry weight on Day 35 at the ≥ 95 μ g ai/L levels. This study is sc ientifically sound and meets the guideline requirements for an early li fe stage toxicity study with fish. It is therefore classified as acceptable.

Acute Toxicity to Mysid Shrimp ( Mysidopsis bahia )

In a 96 hour acute toxicity test, the saltwater mysid shrimp ( Mysidopsis bahia ) were exposed to

flufenacet in measured concentrations of <LOQ (negative control), 0.29, 0.59, 1.2, 2.3, 4.7, 9.5 mg a.i./L(MRID 49119001). After 96 hours, no mo rtality was observed in the control or ≤ 2.3 mg ai/L treatment groups. At 4.7 and 9.5 mg ai/L, mo rtality was 10 % and 50 % respectively after 48 hours, 20% and 70% respectively after 72 hours and 30% and 95%, respec tively after 96 hours. All mysids in the ≤ 2.3 mg ai/L treatment groups appeared normal. In the 4.7 mg ai/L group, lethargy was observed during the 96-hour interval. In the 9.5 mg ai/L gr oup, signs of toxicity (lethargy or surfacing) were observed during the 48-, 72- an d 96-hour intervals. The LC 50 

### was 5.59 (4.72-6.66) mg ai/L classifying flufenacet as moderately toxic to the mysid shrimp. This study was scientifically sound and met the guideline re quirements for an acute toxicity test with

an estuarine/marine inverteb rate and is classified as acceptable

.

Chronic Toxicity to Mysid Shrimp ( Mysidopsis bahia )

A 31 day chronic toxicity test exposed mysid shrimp neonates (< 24 hours old) were exposed to

mean measured treatment concentrations of <LOQ (negative cont rol), 33, 68, 126, 221, 469 ug a.i./L (MRID 49119002). There were not any sta tistical differences in any of the endpoints (F 0 

### survival (pre-pairing and entire study), reproducti on (mean number of young per female), time to first brood, and sex-specific length and dry weight) relative to the negative control. Reproduction (number of offspring per female) did however exhi bit a 34.4 % reduction re lative to the negative

control. The NOAEC and LOAEC values were visu ally determined to be 221 and 469 μg ai/L, respectively due to the magnitude of this reduc tion. This study was scie ntifically sound and met the guideline requirements for a chroni c toxicity test with an estuarine/marine invertebrate and is

classified as acceptable

.

### Page 23 of 118 

### Table 10. Summary of Acute and Chro nic Toxicity Data for Aquatic Taxa Exposed to Flufenacet.

Exposure

Scenario Species Scientific Name Exposure

Duration Toxicity

Reference

Value (ppm) Endpoints

Affected Reference

(Classification)

Freshwater Fish

Acute Bluegill

Sunfish Lepomis

macrochirus 96 hours LC 50 = 2.26 Mortality MRID

43595501

Moderately

Toxic

(Acceptable)

Chronic Rainbow

Trout Oncorhynchus mykiss 289 days NOAEC/

LOAEC =

0.075/0.138 Growth MRID

45796114

(Supplemental)

Freshwater Invertebrate

Acute Isopod Hyalella azteca 96 hours LC 50 = 2.80 Mortality MRID

43595503

Moderately

Toxic (Acceptable)

Chronic Waterflea Daphnia

21 days NOAEC/

LOAEC =

6.3/12.8 Reproduction MRID

43441126

magna (Number of neonates/repro- (Acceptable)

ductive day &

time to first

brood.)

Estuarine Fish

Acute Sheepshead

Minnow Cyprinodon variegatus 96 hours LC 50 =3.38 Mortality MRID

43441122

Moderately

Toxic (Acceptable)

### Page 24 of 118 

### Table 10. Summary of Acute and Chro nic Toxicity Data for Aquatic Taxa Exposed to Flufenacet.

Exposure

Scenario Species Scientific Name Exposure

Duration Toxicity

Reference

Value (ppm) Endpoints

Affected Reference

(Classification)

Chronic Sheepshead

Minnow Cyprinodon variegatus 35 days NOAEC/

LOAEC =

0.049 /

0.095 Growth (standard length and dry weight) MRID

49244201

(Acceptable)

Estuarine Invertebrates

Acute Mysid Shrimp Mysidopsis bahia 96 hours LC 50 =2.72 Mortality MRID

43441121 Moderately

Toxic

(Supplemental)

Acute Mysid Shrimp Mysidopsis bahia 96 hours LC 50 =5.59 (slope 7.3) Mortality MRID

49119001

Moderately

Toxic

(Acceptable)

Chronic Mysid Shrimp Mysidopsis bahia 28 days NOAEC/

LOAEC =

0.012/0.022 Growth,

Larvae Survival, & Young/Female/ MRID

43595502

Reproductive Day (Supplemental)

Chronic Mysid Shrimp Mysidopsis bahia 31 days NOAEC/

LOAEC =

0.221/0.469 Reproduction (number of

young produced per

surviving

female MRID

49119002

(Acceptable)

Aquatic Plants

Non-Vascular Green Algae Pseudokirchneriella subcapitata 120 hours EC50 =

0.0029

Cell Density MRID

43834402

NOAEC or

EC05 =

0.00252 (Acceptable)

### Page 25 of 118 

### Table 10. Summary of Acute and Chro nic Toxicity Data for Aquatic Taxa Exposed to Flufenacet.

Exposure

Scenario Species Scientific Name Exposure

Duration Toxicity

Reference

Value (ppm) Endpoints

Affected Reference

(Classification)

Vascular Duckweed Lemna gibba 14 days EC50 =

0.00245 Plant/Frond Density MRID

43441132

NOAEC or

EC05 =

0.00044 (Acceptable)



## 4.2 Terrestrial Effects Summary

There have been seven new studies submitted examining the toxicity of flufenacet and coformulations of flufenacet and other active ingr edients on both vegetative vigor (Guideline number 850.4250) and seedling emergence (Guideline numbe r 850.4225) of terrestrial plant species.

These studies examine Flufenacet SC 500 (MRIDs 48897605 and 48897609), Flufenacet & Isoxaflutole WG 58 (MRIDs 48897606 and 48897610), Flufenacet and Isoxaflutole SC 480 (MRIDs 48897607 and 48897611), and Axiom 68DF (MRI D 48897688). These studies are still being reviewed. The results of these studies may indicate that fo rmulated products may be more or less toxic to terrestrial plant species than the terrestrial plants studies currently used in this preliminary risk assessment and may result in buffe rs of different widths necessary to mitigate

risk. Results of these studies wi ll be incorporated into the final risk assessment when the results

become available.

There have also been two studies submitted since th e last assessment for acute avian toxicity; acute toxicity to the passerine species Serinus canaria (MRID 49244202) and acute toxicity to the Mallard duck (MRID 44246801). The most sensitive e ndpoints for the remaini ng taxa that will be used in this risk assessment are presented in Table 11 . Refer to the 2010 problem formulation for more comprehensive descriptions of the studies.

Toxicity to the Passerine Serinus canaria

An acute oral toxicity study of flufenacet to adult canaries ( Serinus canaria ) was submitted since the last assessment (MRID 49244202). Flufenacet t echnical was administered neat to the birds via corn oil-coated gelatin capsules at nom inal doses of 0, 135, 236, 413, 723 and 1265 mg ai/kg bw (adjusted for purity) and birds were assesse d for 14 days. Cumulativ e mortality was 10, 0, 10, 40, 90 and 100% in the control, 135, 236, 413, 723 and 1265 mg ai/kg bw dose levels, respectively;

all treatment-related deaths occu rred by Day 1, with no gender-r elated differences. Ataxia and diminished reaction to stimuli (hypo-reactiv ity) were observed in birds from the ≥ 236 mg ai/kg

dose levels. Effects were noted within 1 hour of dosing, and surviving birds from all levels recovered by Day 2. The 14-day acute oral LD 50 

### (with 95% C.I.) was 461 (291 to 598) mg ai/kg bw classifying flufenacet as moderately toxic to a dult canary on an acute oral basis. This study is acceptable and meets guideline require ments for acute oral toxicity with a passerine species.

### Page 26 of 118 

### Toxicity to the Mallard duck Anas platyrhynchos

The acute oral toxicity of FOE 5043 Technical (Flufenacet) to the Mallard Duck was assessed in a 14 day study (MRID 44246801). Approximately 20 week old mallard ducks (6 per treatment level) were exposed to flufenacet at concentra tions of 0, 60, 100, 250, 500, 1000, and 2000 mg a.i./kg bw. Mortality occurred in the tw o highest treatment levels (2 in the 1000 mg a.i./kg bw treatment and 1 in the 2000 mg a.i./ kg bw treatment). The LD 50 

### was determined to be > 2000 mg a.i./kg bw. The birds did not exhibit signs of toxicity or sign ificant differences in body weight gain and there were not any sublethal effects that were not ed. This toxicity study is classified as supplemental as it is scientifically so und but has deficiencies that limit its usefulness. The study only included 6 replicate birds, not the recommended 10.

Table 11. Summary of Toxicity for Terrestrial Taxa Exposed to Flufenacet

Exposure

Scenario Species Scientific

Name Exposure

Duration Toxicity

Reference

Value Effects Reference

(Classification)

Mammals

Acute Laboratory

Rat Rattus norvegicus Acute Oral LD 50 = 589 mg/kg Mortality MRID

43441104

(Acceptable)

Chronic Laboratory

Rat Rattus norvegicus 2-generation reproduction NOAEL =

1.3 mg/kg/day Increase in pup death in early

lactation (including cannibalism). MRID 3850033 (Acceptable)

Invertebrates

Acute

Contact Honey bee Apis mellifera 48 hours > 25 μg

ai/bee Mortality 44112201

(Acceptable)

Birds

Acute(Dosebased) Bobwhite Quail Colinus virginianus 15 days LD 50 = 1608 mg a.i./kg Mortality MRID

43441113

(Acceptable)

Acute(Dosebased) Mallard

Duck Anas platyrhynchos 14 days LD 50 > 2000 mg

a.i./kg Mortality MRID

44246801

(Supplemental)

Acute(Dosebased) Canary Serinus

canaria 14 days LD 50 = 461 mg a.i./kg Mortality MRID

49244202

(Acceptable) Moderately

toxic

### Page 27 of 118 Table 11. Summary of Toxicity for Terrestrial Taxa Exposed to Flufenacet

Exposure

Scenario Species Scientific

Name Exposure

Duration Toxicity

Reference

Value Effects Reference

(Classification)

Acute(Dietarybased) Bobwhite Quail Colinus virginianus 11 days LD 50 = 5317 mg

a.i./kg Mortality MRID

43441114

(Acceptable)

Acute(Dietarybased) Mallard

Duck Anas platyrhynchos 11 days LD 50 = 4970 mg

a.i./kg (slope 6.44) Mortality MRID

43441115

(Acceptable)

Chronic Mallard

Duck Anas platyrhynchos 21 weeks

NOAEL = 88 ppm Increase in

number of eggs cracked

and decrease

in normal hatchlings

and survivors MRID

43441120 (Acceptable)

Reproduction

Plants

Seedling Emergence Sorghum

Sorghum vulgare 21 days EC25 =

0.006 lbs

a.i./A Shoot Dry Weight MRID

43465002

(Monocot) NOAEL =

0.004 lbs

a.i./A (Acceptable)

Tomato

Lycopersicon

esculentum 21 days EC25 =

0.022 lbs

a.i./A Shoot Dry Weight MRID

43465002

(Dicot) NOAEL =

0.007 lbs

a.i./A (Acceptable)

Vegetative

Vigor Sorghum

Sorghum vulgare 21 days EC25 =

0.017 lbs

a.i./A Shoot Height MRID

43465002

(Monocot) NOAEL =

0.008 lbs

a.i./A (Acceptable)

Cucumber

Cucumis

sativus 21 days EC25 =

0.032 lbs

a.i./A Shoot Dry Weight MRID

43465002

(Dicot) NOAEL =

0.016 lbs

a.i./A (Acceptable)

### Page 28 of 118 

## 4.3 Degradate toxicity

As described in Section 3.1 , flufenacet is subject to degrada tion to various products in the environment via multiple pathways via its cleavage to thiadone, and its anilide alcohol, methylsulfoxide, oxylate, and sulfonic acid by-produc ts potentially impacti ng aquatic organisms. Extensive ecological toxicity studies exist with the flufenacet thiadone degradate for aquatic organisms, and results for the studies are shown in Table 12 below. The thiadone degradate is as toxic or slightly less toxic to aquati c animals than parent flufenacet (LC 50 

### range = 8.4 to 31.7 ppm per MRID 45796101, 45796102, 45796103, 45796104, and 45796106). In addition, data suggest equivalent toxicity of thiadone relative to parent flufenacet to aquatic non-vascular and vascular plants. One study since the last assessment was submitted for toxicity of thiadone on aquatic vascular plants, summarized below:

Toxicity to Duckweed ( Lemna gibba )

A 7-day acute toxicity study exposed the fres hwater aquatic vascul ar plants (duckweed, Lemna gibba G3) to Flufenacet-thiadone at mean measured concentrations of <0.100 (<LOQ, negative control), 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L (MRID 48897612). The mean frond

number had inhibitions relati ve to the negative control of 15, 12, 28, 37, 65, 84, and 91% for

mean measured concentrations of 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L, respectively. The frond number growth rate had i nhibitions relative to th e negative control of 6.87, 5.77, 14.2, 19.7, 43.8, 76.6, and 100% for mean measured concentrations of 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L, respectively. Th e frond number yield had inhibitions relative to the negative c ontrol of 17, 14, 31, 41, 71, 92, and 100% for mean measured concentrations of 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L, respectively. The mean

frond area had inhibitions relative to the ne gative control of 13, 11, 30, 45, 73, 88, and 91% for

mean measured concentrations of 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L, respectively. The frond area growth rate had i nhibitions relative to th e negative control of 1.90, 5.81, 11.1, 20.0, 51.4, 88.2, and 98.3% for mean measured concentrations of 1.54, 2.60, 5.13, 10.2, 20.8, 41.3, and 84.1 mg ai/L, respectively. The NOAEC values based on frond number yield, frond number growth rate, and frond area were <1.54 mg ai/L, in terms of mean measured

concentrations. The IC 05 

### for frond area growth rate was 1.101 mg/L and was slightly lower than the range of concentrations tested so should be interpreted with some caution. IC 50 

### values based frond area was 10.34 mg ai/L. This study is scientifically sound and meets the guideline requirements for a toxicity test us ing a freshwater vascular plant. It was therefore classified as acceptable

.

### Page 29 of 118 Table 12. Summary of endpoints in aquatic toxicity studies for the flufenacet thiadone degradate.

Test Group Species Scientific

Name Exposure

Duration Toxicity

Reference

Value (ppm) Endpoints

Affected Reference

(Classification)

Vascular with

flufenacetthiadone Duckweed Lemna gibba 14 days EC50 =

10.34

Frond area MRID

48897612

NOAEC

or EC 05 =

1.101 (Acceptable)

Non-Vascular

with Thiadone Green Algae Seleanstrum capricornutum 120 hours EC50 =

6.4 Cell Density MRID

45796115

NOAEC

or EC 05 =

0.94 (Acceptable)

Freshwater fish Bluegill

Sunfish Lepomis

macrochirus 96 hrs LC 50 = 18.6 Mortality MRID

45796101

Slightly toxic

(Supplemental)

Freshwater fish Rainbow

Trout Oncorhynchus mykiss 96 hrs LC 50 = 8.4 Mortality MRID

45796102

Moderately

toxic

(Supplemental)

Freshwater

Invertebrate Daphnid Daphnia Magna 96 hrs LC 50 = 31.7 Mortality MRID

45796103

Slightly toxic

(Acceptable)

Estuarine/Marine

Fish Sheepshead

Minnow Cyprinodon variegatus 96 hrs LC 50 =15.3 Mortality

and

sublethal

effects MRID

45796104

Slightly toxic

(Supplemental)

Estuarine/Marine

Invertebrate Saltwater Mysid Mysidopsis

bahia 96 hrs LC 50 >
15.1 Mortality MRID

45796106

Slightly toxic

(Acceptable)



### For the additional degradates in the aquati c environment, the ECOSAR (v.1.11) module of EPISUITE (v.4.1) was employed to es timate the toxicity of these de gradates as compared to the registrant submitted studies available for parent flufenacet and the thiadon e degradate. ECOSAR uses structure activity relationships (SAR) to pred ict the toxicity of compounds that share similar

### Page 30 of 118 

### structural moieties. Th e toxicity of each degr adate is presented in Table 13 to enable comparison to laboratory submitted studies. ECOSAR indicates th at only thiadone is predicted to have similar toxicity to the parent flufenacet compound. ECOS AR modelling suggested that the degradates were significantly less toxic than the parent compound. Because of this only registrant submitted toxicity studies for both the parent flufenacet compound and flufenacet’s thiadone degradate were used to compare to estimated environmental con centrations. Registrant submitted studies on both flufenacet and thiadone suggest however that flufen acet is more toxic than the thiadone degradate, particularly for aquatic plants. Regardless, the stressor of concern for ecological risk in aquatic

environments will consider both residues of parent flufenacet and its thiadone degradate, since these compounds possess most toxicity by a wide margin as opposed to its anilide degradates. Furthermore, thiadone is included in this assessment since it is observed to reach very high levels, up to 84.3 percent of applied flufenacet.

Table 13. ECOSAR predicted toxicity (m g a.i/L) of flufenacet degradates.

Stressor (Endpoint

Source) Endpoint (in mg a.i/L)

ECOSAR

CLASS Vascular

Plant (EC50 / NOAEC) Nonvascular

Plant (EC50 / NOAEC) Freshwater

Fish LC 50 /

NOAEC Freshwater

Invertebrate

EC 50 /

NOAEC (different species) Estuarine/

Marine

Fish LC 50 Estuarine

/Marine

Invertebr

ate EC 50

Flufenacet (registrant

submitted studies) NA 0.00245 /

0.00044 0.0029 /

0.00252 2.26 / 0.075 2.8 / 6.3 3.38 2.72

Flufenacet (ECOSAR estimates) Amides 0.614 /

0.956 0.614 /

0.956 15.059 /

0.053 9.5 / 1.18 13.464 1.2

Thiadone (registrant

submitted studies) 

### NA 1.34/1.01 6.4/0.94 8.4 31.7 15.3 >15.1

Thiadone (ECOSAR estimates) Hydrazines

/Thiocarba

mates 0.39 / 0.14 0.39 / 0.14 1.3 / 0.05 4.4 / 0.24 3.9 2.7

Methylsulf

ide (ECOSAR Estimate)* Amides 55 / 21 55 / 21 2807 / 1.3 8441 / 112 2425 77

Oxalate (ECOSAR Estimate) Neutral Organics 531/ 108 531/ 108 2219 / 190 1127 / 81 144 573

### Page 31 of 118 

### Table 13. ECOSAR predicted toxicity (m g a.i/L) of flufenacet degradates.

Stressor (Endpoint

Source) Endpoint (in mg a.i/L)

ECOSAR

CLASS Vascular

Plant (EC50 / NOAEC) Nonvascular

Plant (EC50 / NOAEC) Freshwater

Fish LC 50 /

NOAEC Freshwater

Invertebrate

EC 50 /

NOAEC (different species) Estuarine/

Marine

Fish LC 50 Estuarine

/Marine

Invertebr

ate EC 50

Sulfonic

Acid (ECOSAR Estimate)* Amidesacid 97.6 / 62 97.6 / 62 3793 / 3.7 6406 / 195 3319 157

Flufenacet

Alcohol (ECOSAR Estimate) Amides 4.2/ 3.2 4.2/ 3.2 150 / 0.189 211 / 8.4 132.5 7.1



### In terrestrial environments, pare nt flufenacet is moderately pers istent in the environment with

aerobic soil metabolism half-lives of 34 to 64 days. Furthermore, si nce thiadone itself has a short half-life in terrestrial environments, its availabili ty to terrestrial animals on an acute or long-term basis may be limited, decreasing the potential for acute and chronic risk to these species. Therefore, given the resulting limi ted exposure anticipated to terrestrial plants and animals, modeling exposure to these organisms will use parent flufenacet alone.



## 4.4 ECOTOX Open Literature

Open literature studies are identified us ing EPA’s ECOTOXicology database (ECOTOX) (USEPA, 2007 c ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected communities. Findings from this su rvey did not provide any information that would significantly affect this risk assessment.



## 4.5 Review of Incident Data

Incident reports submitted to EPA since approximately 1994 have been tracked by assignment of “incident numbers” in an Incident Data System (IDS), microfiched, and then entered into a second database, the Ecological Incident Information Sy stem (EIIS; USEPA 2007b). An effort has also

been made to enter information to EIIS on incide nt reports received prior to establishment of current databases. Incident reports are not received in a consistent format ( e.g. , states and various laboratories usually have their own formats), may involve multiple incidents involving multiple chemicals in one report, and may report only part of a given incident investigation ( e.g. , residues). While some progress has been made in recent years in getting incident reports submitted and

### Page 32 of 118 

### entered, there has never been the level of resources a ssigned to incidents that there has been assigned to the tracking and review of la boratory toxicity studies, for example.

A preliminary review of the EIIS and the Avia n Monitoring Information System (AIMS), which is maintained by the American Bird Conservancy, indicates there are no incidents for wildlife. However, there are 64 plant incide nt reports involving te rrestrial exposure to flufenacet that have been reported and none that involve aquatic species. Flufenacet wa s applied to agricultural crops (corn, soybeans, and winter wheat) and in most cas es the treated crop itself was affected. Only two incidents showed that flufenacet damaged crops via drift to another crop. The magnitude of damage ranged from a small area (1 acre) to the en tire treated crop, with most being at least greater than 50% of the treated crop or more than 100 acres.

In addition to the incidents recorded in EIIS, addi tional incidents have been reported to the Agency in aggregated incident reports. Pesticide registra nts report certain types of incidents to the Agency as aggregate counts of incidents occurring per product pe r quarter. Ecological incidents reported in aggregate reports include those categorized as “minor fish and wildlife” (W-B), “minor plant” (P-B), and “other nontarget” (ONT ) incidents. “Other nontarget” incidents include reports of

adverse effects to insects and other terrestrial i nvertebrates. For flufen acet, registrants have reported 994 minor plant incidents but no minor fish and wildlife incide nts or other nontarget

incidents.

In the risk assessment, the incidents will be furthe r evaluated to determine if the reported incidents

represent current patterns of use for flufenacet. Examples of additional considerations are mitigation ( e.g ., reduced application rates), product cancellations, and ch anges in use patterns that

have occurred since the date of the reported incidents.

An absence of reported incidents should not be c onstrued as the absence of incidents. Incident reports for non-target organisms typically provide information only on mortality events and plant damage incidents. Except for phytotoxic effects in terrestrial plants, sublethal effects, such as reduced growth or impaired reproduction, are rare ly reported. EPA’s changes in the registrant reporting requirements for incidents in 1998 may account for a reduced number of reported incidents. Registrants are now only required to submit detailed information on ‘major’ fish, wildlife, and plant incidents. Mi nor fish, wildlife, and plant incide nts, as well as all other nontarget incidents, are generally reported aggregately and ar e not included in the EIIS. In addition, there have been changes in state monitoring efforts due to a lack of resources. However, the incident data that are available suggest that exposure pathways for flufenacet are complete and that exposure levels are sufficient to resu lt in field-observable effects.



# 5. Risk Characterization

Risk characterization is the integration of expos ure and effects characteriz ation to determine the ecological risk from the use of flufenacet and the likelihood of eff ects on aquatic life , wildlife, and plants based on varying pesticide- use scenarios. The risk charac terization provides an estimation and a description of the risk ; articulates risk assessment assumptions, limitations, and uncertainties; synthesizes an overall conclusion; and provides the risk managers with information to make regulatory decisions.

### Page 33 of 118 

## 5.1. Risk Estimation

Results of the exposure modeling and toxicity eff ects data are used to evaluate the likelihood of adverse ecological effects on non-target species. For the assessment of flufenacet risks, the risk quotient (RQ) method is used to compare expos ure and measured toxicity values (refer to Appendix G ). Estimated environmental concentrations (EECs) are divided by the most sensitive acute and chronic toxicity values. The RQs are th en compared to the Agency’s levels of concern (LOCs). These LOCs, summarized in Appendix G , are the Agency’s inte rpretive policy and are used to analyze potential risk to non-target organisms and the need to consider regu latory action.

These criteria are used to indicat e when a pesticide’s use as directed on the label has the potential

to cause adverse effects on non-target organisms.

a) Non-target Aquatic Animals and Plants

 Acute Risk to Aquatic Animals

Acute RQs were derived for exposur e of freshwater and estuarine/ma rine fish and invertebrates to total toxic residues including the parent a. i. flufenacet and its degradate thiadone ( Table 14 ). No acute RQs exceeded the LOCs for acute risk (0.5), acute restricted use (LOC 0.1), or acute listed risk (LOC 0.05) for the modeled crops for either th e parent a.i. alone, thia done alone, or the total toxic residues resulting from flufenacet ap plication. RQs ranged from <0.01 to 0.01.

Table 14. Acute RQs for fish and aqua tic invertebrates exposed to the

total toxic residues of flufenacet (parent plus thiadone degradate).

Use/

SWCC

Scenario Surface

Water

EECs (Peak) FW

Fish FW

Invert SW

Fish SW

Invert FW

Fish FW

Invert SW

Fish SW

Invert

LC /

EC50 LC /

EC50 LC /

EC50 LC /

EC50 RQ RQ RQ RQ

(μg/L) (μg/L) (μg/L) (μg/L) (μg/L)

Corn (IL Corn) 26 2260 2800 3380 5,590 0.01 0.01 0.01 0.00

Soybeans (MI Beans) 9 2260 2800 3380 5,590 <0.01 <0.01 <0.01 <0.01

Grass Seed (OR Grass Seed) 5 2260 2800 3380 5,590 <0.01 <0.01 <0.01 <0.01

Wheat and

Triticale (ND Wheat) 7 2260 2800 3380 5,590 <0.01 <0.01 <0.01 <0.01



###  Chronic Risk to Aquatic Animals

### Page 34 of 118 

### Chronic RQs were derived for exposure of freshwat er fish and invertebrates and estuarine/marine

invertebrates to total toxic resi dues that included the parent a. i. flufenacet and its degradate thiadone ( Table 15 ). No chronic RQs exceeded the LOC (1) for the modeled crops from either the parent a.i. alone (flufenacet ), thiadone alone, or the total t oxic residues (flufenacet+thiadone) resulting from flufenacet application. RQs ranged from <0.01 to 0.48.

Table 15. Chronic RQs for fish and aquatic invertebrates exposed to the total toxic residues of flufenacet (paren t plus thiadone degradate).

Use/

SWCC

Scenario Surface Water

EECs 

### FW

Fish FW

Invert SW

Fish SW

Invert FW

Fish FW

Invert SW

Fish SW

Invert

21-day 60-day 

### NOAEC NOAEC NOAEC NOAEC RQ RQ RQ RQ (μg/L) (μg/L) (μg/L) (μg/L) (μg/L)

Corn (IL Corn) 25 24 

### 75 6300 49 221 0.32 <0.01 

### 0.48 0.11

Soybeans (MI Beans) 9 8 

### 75 6300 49 221 0.11 <0.01 

### 0.17 0.04

Grass

Seed (OR

Grass Seed) 4.3 4.1 

### 75 6300 49 221 0.06 <0.01 

### 0.08 0.02

Wheat

and

Triticale (ND Wheat) 7 6 

### 75 6300 49 221 0.08 <0.01 

### 0.13 0.03



### * Fish toxicity data was compared to the 60 day EEC while the invertebrate toxicity data was compared to the 21 day EEC.



###  Risk to Aquatic Plants

RQs are first derived for exposure of aquatic plants considering total toxic residues (flufenacet and thiadone) ( Table 16 ). RQs exceeded the LOC for both vascul ar and non-vascular plants for all the modeled crops for both the parent a.i. a nd total toxic residues for both listed and non-listed species. RQs for the total toxic residues ranged from 1.6 to 60.2. Given these exceedances, the formation-decline method utilized in aquatic expos ure estimation allows fo r further pr esentation of the parent a.i. contribution a nd thiadone degradate cont ribution to the overal l total toxic residue RQ. Flufenacet only and thiadone only RQs are presented in Table 17 . The RQs still exceeded for the parent a.i. alone ranging from 1.0 to 39.5. However, there were not any LOC exceedances

for either listed or non-li sted aquatic plants when exposed to the degradate thiadone alone with all RQs less than 0.01 because thiadone is much less toxic than the parent flufencacet.

### Page 35 of 118 

### Table 16. RQs for non-vascular and vascular plan ts exposed to the total toxic residues of flufenacet (parent flufenacet plus thiadone degradate).

Use/

SWCC

Scenario Peak

Surface

Water

EECs (μg/L) 

### Toxicity Values (μg/L) 

### RQs

Non

‐ Vascular

Plant Vascular Plant Non

‐ Vascular

Plant Vascular Plant

Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed

EC50 NOAEC EC50 NOAEC EC50 NOAEC EC50 NOAEC

Corn (IL Corn) 

### 26 2.90 2.52 2.45 0.44 9.1 10.5 10.8 60.2

Soybeans (MI Beans) 

### 9 2.90 2.52 2.45 0.44 3.1 3.6 3.7 20.5

Grass

Seed (OR

Grass Seed) 

### 5 2.90 2.52 2.45 0.44 1.6 1.8 1.9 10.3

Wheat

and

Triticale (ND Wheat) 

### 7 2.90 2.52 2.45 0.44 2.3 2.7 2.7 15.2

* RQs exceeding the LOCs shown in bold text.



### Table 17. RQs for non-vascular and vascular pl ants exposed to the parent a.i. only and thiadone degradate only.

Use/

SWCC

Scenario Peak

Surface

Water

EECs (μg/L) 

### Toxicity Values (μg/L) 

### RQs

Non

‐ Vascular

Plant Vascular Plant Non

‐ Vascular

Plant Vascular Plant

Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed

EC50 NOAEC EC50 NOAEC EC50 NOAEC EC50 NOAEC



## Flufenacet (parent only)

Corn (IL Corn) 17.4 

### 2.9 2.5 2.5 0.4 6.0 6.9 7.1 39.5

Soybeans (MI Beans) 5.6 

### 2.9 2.5 2.5 0.4 1.9 2.2 2.3 12.8

Grass Seed (OR Grass Seed) 2.8 

### 2.9 2.5 2.5 0.4 1.0 1.1 1.2 6.5

Wheat and

Triticale (ND Wheat)

3.9 

### 2.9 2.5 2.5 0.4 1.3 1.5 1.6 8.8

### Page 36 of 118 

### Table 17. RQs for non-vascular and vascular pl ants exposed to the parent a.i. only and thiadone degradate only.

Use/

SWCC

Scenario Peak

Surface

Water

EECs (μg/L) 

### Toxicity Values (μg/L) 

### RQs

Non

‐ Vascular

Plant Vascular Plant Non

‐ Vascular

Plant Vascular Plant

Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed Non

‐ listed Listed

EC50 NOAEC EC50 NOAEC EC50 NOAEC EC50 NOAEC



## Thiadone (degradate only)

Corn (IL Corn) 9 

### 6400 940 10340 1010 <0.01 <0.01 <0.01 <0.01

Soybeans (MI Beans) 3 

### 6400 940 10340 1010 <0.01 <0.01 <0.01 <0.01

Grass Seed (OR Grass Seed) 2 

### 6400 940 10340 1010 <0.01 <0.01 <0.01 <0.01

Wheat and

Triticale (ND Wheat) 3 

### 6400 940 10340 1010 <0.01 <0.01 <0.01 <0.01

* RQs exceeding the LOCs shown in bold text.



### b) Non-target Terrestrial Animals

 Acute Risk to Birds and Mammals

Avian Species

Acute RQs were derived for exposure of birds ( Table 18 ) using toxicity endpoints for the canary (MRID 49844202). Dose-based RQs exceeded the endangered species LOC (0.1) for 20g ‘small’ birds that feed on short grass and broadleaf plants for all uses of flufenacet (RQs ranged from 0.12 to 0.48). Dose based RQs for small birds range d from 0.08 to 0.27 for tall grass and arthropods with all uses except for wheat exceeding the en dangered species LOC. RQs did not exceed the endangered species LOC for fruits/pods.

Dose-based RQs exceeded the endangered species LOC (0.1) for 100 g ‘medium’ birds that feed on short grass for all uses excep t wheat with RQs ranging from 0.09 to 0.22. The listed species LOC (0.1) was also exceeded at the highest applic ation rate used on corn in the tall grass and broadleaf plant categories. There were not any other LOC exceedances for any other dietary items

for medium or la rge birds.

### Page 37 of 118 Table 18. Acute dose

‐ based RQs for birds due to exposure to proposed uses of flufenacet.

Use (application

rate ‐ lbs a.i./A) Small Medium LargeShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeeds

Corn (Sweet and

Field)
(0.8019) 0.48 0.22 0.27 0.03 0.19 0.01 0.22 0.10 0.12 0.01 0.08 <0.01 0.07 0.03 0.04 <0.01 0.03 <0.01

Soybean (0.4644) 0.28 0.13 0.16 0.02 0.11 0.00 0.12 0.06 0.07 0.01 0.05 <0.01 0.04 0.02 0.02 <0.01 0.02 <0.01

Grass Seed

(0.442) 0.27 0.12 0.15 0.02 0.10 0.00 0.12 0.05 0.07 0.01 0.05 <0.01 0.04 0.02 0.02 <0.01 0.01 <0.01

Wheat and

Triticale
(0.3448) 0.21 0.09 0.12 0.01 0.08 0.00 0.09 0.04 0.05 0.01 0.04 <0.01 0.03 0.01 0.02 <0.01 0.01 <0.01

Acute listed species LOC = 0.1; Acute Restricted Use LOC = 0.2; Non

‐ listed animals acute LOC = 0.5 * RQs exceeding the LOCs shown in bold text.



### Mammalian Species

Definitive acute dose-based RQ values for mammalian receptors ranged from <0.01 to 0.14 ( Table 19 ). Based on these results, endangered sp ecies LOC (0.1) was exceeded for 15g and 35g mammals that feed on short grass adjacent to sweet corn and soybe ans applications of flufenacet. No dietary data were submitted.

Table 19. Acute dose based RQs for mammals for flufenacet uses.

Use (application

rate ‐ lbs a.i./A) Small Medium LargeShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeeds

Corn (Sweet and

Field)
(0.8019) 0.14 0.06 0.08 0.01 0.06 <0.01 0.12 0.06 0.07 0.01 0.05 <0.01 0.06 0.03 0.04 <0.01 0.03 <0.01

Soybean
(0.4644) 0.08 0.04 0.05 0.01 0.03 <0.01 0.07 0.03 0.04 <0.01 0.03 <0.01 0.04 0.02 0.02 <0.01 0.01 <0.01

Grass Seed

(0.442) 0.08 0.04 0.04 <0.01 0.03 <0.01 0.07 0.03 0.04 <0.01 0.03 <0.01 0.04 0.02 0.02 <0.01 0.01 <0.01

Wheat and

Triticale
(0.3448) 0.06 0.03 0.03 <0.01 0.02 <0.01 0.05 0.02 0.03 <0.01 0.02 <0.01 0.03 0.01 0.02 <0.01 0.01 <0.01

### Page 38 of 118 Table 19. Acute dose based RQs for mammals for flufenacet uses.

Use (application

rate ‐ lbs a.i./A) Small Medium LargeShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeedsShortGrassTallGrassBroadleafPlantsFruits/podsArthropodsSeeds

Acute listed species LOC = 0.1; Acute Restricted Use LOC = 0.2; Non

‐ listed animals acute LOC = 0.5 * RQs exceeding the LOCs shown in bold text.



###  Chronic Risk to Birds and Mammals

Avian Species

Chronic dietary-based RQs for birds ranged from 0.06 to 2.19 ( Table 20 ). RQs in the short grass dietary item exceeded the chronic LOC of 1.0 for all uses except for wheat and ranged from 1.21 to 2.19. The use rate of corn exceeded the chronic LOC for all dietary items that included short grass, tall grass, and broadleaf plants.

Table 20. Chronic dietary

‐ based RQs for birds due to exposure to proposed uses of flufenacet.

Use (application rate ‐ lbs a.i./A)ShortGrassTallGrassBroadleafPlantsFruits/podsArthropods

Corn (Sweet and Field)
(0.8019) 2.19 1.00 1.23 0.14 0.86

Soybean (0.4644) 1.27 0.58 0.71 0.08 0.50

Grass Seed

(0.442) 1.21 0.55 0.68 0.08 0.47

Wheat and Triticale
(0.3448) 0.94 0.43 0.53 0.06 0.37

Chronic LOC = 1.0 * RQs exceeding the LOCs shown in bold text.



### Mammalian Species

Chronic dietary-based RQs for mammals ranged from 0.2 to 7.4 ( Table 21 ). The chronic RQs for flufenacet uses on corn, soybean, grass seed, and wheat triticale (application rates ranging from 0.3448 lbs a.i./A to 0.8019 lbs a.i./A) exceeded the chronic LOC for all dietary items but fruits/pods.

### Page 39 of 118 Table 21. Chronic dietary based RQs for mammals due to exposed to proposed uses of

flufenacet.

Use (application rate ‐ lbs a.i./A)ShortGrassTallGrassBroadleafPlantsFruits/podsArthropods

Corn (Sweet and Field)

0.8019 7.4 3.4 4.2 0.5 2.9

Soybean (0.4644) 4.3 2.0 2.4 0.3 1.7

Grass Seed 0.442 4.1 1.9 2.3 0.3 1.6

Wheat Triticale (0.3448) 3.2 1.5 1.8 0.2 1.2

Chronic LOC = 1.0

All values are chronic values * RQs exceeding the LOCs shown in bold text.



###  Risks to Piscivorous Birds and Mammals

Given the indications that flufenacet residues will bioaccumulate in the tissues of exposed fish, there is the potential for flufenacet exposure to piscivorous birds and mammals through diet.

KABAM v.1.0 was run on the use which resulted in th e highest exposure in the environment (corn, application rate = 0.80 19 lbs. a.i./A – see Table 3 ). There were not any acute or chronic exceedances that resulted from the highest applica tion rates of flufenacet. The resulting acute and chronic RQs are all <0.01 for piscivorous birds and ranged from <0.01 for acute exposure to 0.2 for dose based chronic exposure for piscivorous mammals. The KABAM run can be accessed in Appendix F. These minimal impacts are expected given flufenacet’s moderate log K ow 

### of 3.20

and BCF of 103X.

c) Risk to Non-target Terrestrial Plants

There are seven studies that are still in review that examine the toxicity of flufenacet and coformulations of flufenacet and other active herb icidal ingredients on both vegetative vigor (Guideline number 850.4250) and seedling emerge nce (Guideline number 850.4225) of terrestrial plant species. These studies examine Flufenacet SC500 (MRIDs 48897605 and 48897609), Flufenacet & Isoxaflutole WG 58 (MRIDs 48897606 and 48897610), Flufenacet and Isoxaflutole SC 480 (MRIDs 48897607 and 48897611), and Axiom 68DF (MRID 48897688). The results of these studies may indicate that fo rmulated products may be more or less toxic to terrestrial plant species than the terrestrial plants studies currently used in this preliminary risk assessment and may result in buffers of different widths necessary to mitigate risk. Results of these studies will be incorporated into the final risk assessment when the results become available.

RQs resulting from off-site transport from runoff a nd spray drift of flufenacet are presented below. In general, monocots were more sensitive to fluf enacet than dicots. RQs ranged from 0.6 to 25.5

for monocots and from 0.2 to 14.6 for dicots.

The risk resulting from the movement of flufenacet residues to irrigation water that may be applied to non-target plants and crops is discu ssed in the Risk Description Section ( Section 5.2 ). Exposure

### Page 40 of 118 

### estimates for this exposure pathway are based on peak flufenacet surface water column concentrations as presented in Table 3 for each use.

Monocotyledon Species

RQs for monocots ranged from 0.6 to 22.1. Us es on corn (application rates 0.8019) exceeded

both the listed and non-listed LOC of 1.0 for every scenario modeled ( Table 22 ). Uses on soybean, grass seed, and wheat (application rates 0.4644, 0.442, 0.3448 lbs a.i./A respectively) exceeded the listed species LOC for every scenario modele d and non-listed species’ LOC for both the runoff and spray drift in both dr y and semi-aquatic areas.

Table 22. Monocot RQs from applicatio ns of flufenacet in the modeled scenarios of Runoff and Spray Drift in Dry areas, Runoff and Spray Drift in Semi-Aquatic Areas, and Spray Drift only

.

Use (application rate ‐ lbs a.i./A) Monocot RQ Values

Runoff and Runoff and

Spray Drift Only Spray Drift Spray Drift

(Dry Areas) (Semi

‐ Aquatic Areas)

Nonlisted

Species Listed
Species 1 Nonlisted
Species Listed
Species 1 Nonlisted
Species Listed
Species

Corn (Sweet and Field)
(0.8019) 

### 2.7 4.0 14.7 22.10 1.3 2.0

Soybean (0.4644) 

### 1.5 2.3 8.5 12.8 0.8 1.2

Grass Seed

(0.442) 

### 1.5 2.2 8.1 12.2 0.7 1.1

Wheat and

Triticale
(0.3448) 

### 1.7 2.6 12.1 18.1 0.6 0.9

* RQs exceeding the LOCs shown in bold text.



### Dicotyledon Species

RQs for dicots ranged from 0.02 to 14.6 ( Table 23 ). Use on corn (application rate = 0.8019 lbs a.i./A) exceeded the listed speci es LOC for every scenario mode led. The non-listed species LOC was only exceeded for corn in the runoff and spray dr ift in semi-aquatic areas scenario. For use on soybeans, grass seed, and wheat (applicati on rates 0.46, 0.442, 0.3448 lbs a. i./A respectively) RQs ranged from 0.2 to 10.3. RQs exceeded the lis ted species LOC for only the runoff and spray drift in dry and semi-aquatic areas but not in the spray dr ift only scenario. The RQ from soybean and grass seed applications exceeded the non-listed species LOC only in the runoff and spray drift in semi-aquatic areas scenario.

### Page 41 of 118 

### Table 23. Dicot RQs from applicatio ns of flufenacet in the modeled scenarios of Runoff and Spray Drift in Dry areas, Runoff and Spray Drift in Semi-Aquatic Areas, and Spray Drift only.

Use (application rate ‐ lbs a.i./A) Monocot RQ Values

Runoff and Runoff and

Spray Drift Only Spray Drift Spray Drift

(Dry Areas) (Semi

‐ Aquatic Areas)

Nonlisted

Species Listed
Species 1 Nonlisted
Species Listed
Species 1 Nonlisted
Species Listed
Species

Corn (Sweet and
Field)
(0.8019) 

### 0.7 2.3 4.0 12.6 0.4 1.1

Soybean (0.4644) 

### 0.4 1.3 2.3 7.3 0.2 0.7

Grass Seed

(0.442) 

### 0.4 1.3 2.2 6.9 0.2 0.6

Wheat and

Triticale
(0.3448) 

### 0.5 1.5 3.3 10.3 0.2 0.5

* RQs exceeding the LOCs shown in bold text.



### d) Risk to Terrestrial Invertebrates

Bees may be exposed to flufenacet via direct appli cations, drift from boom or aerial spray, or from residues on treated crops. There ar e no any acute or chronic toxicity studies submitted for larval bees or chronic feeding studies for adult bees. Therefore, RQs resulting from only contact exposure to flufenacet re sidues are presented in Table 24 . The RQs are less than values because the toxicity endpoint did not show any toxicity at the highest con centrations tested. Using these values the RQ is not expected to be higher than those report for acute contact exposure.

### Page 42 of 118 

### Table 24. Contact RQs for bees that result from applications of flufenacet.

Use (Application Rate

‐ lbs a.i./A) Contact RQs

Corn (Sweet and Field)
(0.8019) 

### <0.09

Soybean
(0.4644) 

### <0.05

Grass Seed

(0.442) 

### <0.05

Wheat & Triticale
(0.3448) 

### <0.04

Acute LOC for bees is 0.4.



### Using calculations from Bee-Rex modeling, the RQ s for contact ranged from <0.04 to <0.09 which were below the Agency’s established LOC of 0.4. Based on this, the risk from contact exposure is expected to be low. The timing of applica tion may also reduce exposur e to pollinators if early in the growing season when plants are not flower ing. There was not an acute oral study submitted for flufenacet. If the endpoint was sim ilar to that of the contact study (>25  g/bee) which was practically non-toxic RQs woul d range from <0.4 to <1.0.



## 5.2. Risk Description

5.2.1 Risk to Non-Target Aquatic Organisms

Aquatic Animals

The acute studies that test the toxicity of TGAI to freshwater and estuarine/marine fish and invertebrates, indicate that flufen acet is slightly to moderately t oxic on acute basis. This coupled with low estimated aquatic concentrations results in RQs below the level of concern for these taxa.

Risk estimates for freshwater and estuarine/marine fish and invertebrates show that flufenacet does not pose acute risks to these taxa ( Table 14) . It also does not pose indi rect risk for non-listed or listed species that rely on them as a food source. In addition, results of st udies testing toxicity of aquatic animals to thiadone, show th at thiadone is as toxic as or less toxic than the parent. Therefore, the risk to thiadone will likely be low as well.

The chronic studies that test th e toxicity of TGAI to these or ganisms showed higher toxicity; however, due to the low levels of flufenacet estim ated to contaminate waterways, RQs were low

and showed no chronic risk to freshwater fish a nd freshwater and estuarine/marine invertebrates ( Table 15 )

Based on the available data, the po tential for acute and chronic risk s to aquatic animals is low. However, a potential for indirect effects to these species does exist because of the high risks to aquatic plants (see below). Ma ny aquatic animals are directly and/or indirectly dependent upon aquatic plants for food and/or sh elter during various life-stages.

### Page 43 of 118 

### Aquatic Plants

Based on data and the predicted aquatic exposures, there is potential risk to non-listed and listed vascular and non-vascular plant species ( Table 16 ). RQs were exceeded for listed and non-listed vascular and non-vascular plants for all crop uses modeled for the total toxic residues flufenacet and its thiadone degradate. However given th ese exceedances, RQs calculated from flufenacet and thiadone specific EECs are fu rther explored. RQs resulting from exposure to thiadone alone did not result in any LOC exceedance for either li sted or non-listed species from any use that was modeled due to thiadone being less toxic than the parent flufenacet compound ( Table 17 ).

Since flufenacet is applied as a spray, non-target aquatic plants may come into contact with flufenacet and its degradates in runoff or spray drif t. Flufenacet’s moderate mobility suggests that it does have the ability to be transported via runoff and erosion to water systems. Several small detections and one large detecti on of flufenacet up to 75 ppb in surface water monitoring data provides evidence supporting this exposure scen ario. In addition, si nce this product is a preplant/pre-emergent herbicide, there will be little vegetation on the field to filter the drift movement of the spray droplets. Once in the wa ter, flufenacet is stable to hydrolysis and photolysis. Thiadone, the metabolite of concern is al so stable to hydrolysis and is persistent in aquatic conditions. Therefore, if flufenacet ente rs water systems, non-target aquatic plants may

be at risk.

Overall, the contribution of spray drif t to the overall risk to aquatic plants is small. This is due to flufenacet’s ability to runoff in larg e quantities in the areas of the c ountry that it used. Furthermore, ground spray applications which are used in the va st majority of flufenacet uses limit the overall impacts from spray drift. Table 25 shows the RQs which result from runoff impacts only. Risks remain for vascular listed species with all flufenacet uses. Figures 3, 4, 5, and 6 show only slight reductions to RQs when spray drift is eliminated with the corn, soybean, wheat/triticale, and grass seed uses with ground spray applications. . Ho wever, RQs still remain above the LOCs for all uses except for the grass seed use where RQs fall below the LOCs when spray drift has not impact

with non-listed and listed non vascul ar plants and non-listed vascul ar plants. Given that runoff appears to drive the risk to all aquatic plants fo r all of the uses for ma ny cases, spray drift buffer zones are not likely to result in substantial mitigati on of the risk which is found for aquatic plants. It is possible that spray drift may drive the risk in other regions not shown herre, particularly in

the Western U.S. over drier areas where flufenacet is applied. However, exploratory analysis using the AgDrift model indicates that spray drift bu ffer zones required to mitigate the risk extend beyond 1,000 feet and therefore are not feasible to implement.

Table 25. Runoff-only risk quotients and resulti ng risk conclusions due to flufenacet and thiadone exposure to aquatic plants.

Use Risk Quotients and Remaining Risk Conclusions Without Spray Drift (Yes/No)

Non-Vascular

Non-Listed Non-Vascular

Listed Vascular

Non-Listed Vascular

Listed Corn 7.4 (Yes) 8.6 (Yes) 8.8 (Yes) 49.2 (Yes) Soybean 1.9 (Yes) 2.2 (Yes) 2.3 (Yes) 12.6 (Yes) Wheat/Triticale 0.6 (No) 0.7 (No) 0.8 (No) 4.1 (Yes)

### Page 44 of 118 

### Table 25. Runoff-only risk quotients and resulti ng risk conclusions due to flufenacet and thiadone exposure to aquatic plants.

Use Risk Quotients and Remaining Risk Conclusions Without Spray Drift (Yes/No)

Non-Vascular

Non-Listed Non-Vascular

Listed Vascular

Non-Listed Vascular

Listed Grass Seed 1.5 (Yes) 1.8 (Yes) 1.8 (Yes) 10.1 (Yes)

Figure 3. Comparison of total runoff and spray-drift RQs and runoff-only RQs for non vascular, non-listed aquatic plant species. 0 10 20 30 40 50 60 70

Corn Forestry Soybeans Grass Seed Wheat and TriticaleRiskQuotients 

## Overall Contribution of Spray Drift on Non Vascular Aquatic Plant

Non

‐ Listed Species Risk Quotients for Flufenacet Uses

RQ's: Runoff and

Spray Drift

RQs: Runoff and

No Spray Drift

LOC

### Page 45 of 118 

### Figure 4. Same as figure 3 except for non vascular, listed aquatic plant species. 0 10 20 30 40 50 60 70

Corn Forestry Soybeans Grass Seed Wheat and TriticaleRiskQuotients 

## Overall Contribution of Spray Drift on Non Vascular Aquatic Plant

Listed Species Risk Quotients for Flufenacet Uses

RQ's: Runoff and

Spray Drift

RQs: Runoff and

No Spray Drift

LOC

### Page 46 of 118 

### Figure 5. Same as figure 3 except for vas cular, non-listed aquatic plant species. 0 10 20 30 40 50 60 70

Corn Forestry Soybeans Grass Seed Wheat and TriticaleRiskQuotients 

## Overall Contribution of Spray Drift on Vascular Aquatic Plant

Non

‐ Listed Species Risk Quotients for Flufenacet Uses

RQ's: Runoff and

Spray Drift

RQs: Runoff and

No Spray Drift

LOC

### Page 47 of 118 

### Figure 6. Same as figure 3 except for vascular, listed aquatic plant species.



## 5.2.2 Risk to Non-Target Terrestrial Organisms

The nature of the magnitude and duration of risk resulting from acute a nd chronic exposure via

intake of flufenacet residues for birds and mammal s is discussed below. Based on the nature of pre-emergent applications with flufenacet, the mo st direct risks will resu lt from ingestion of arthropods and seeds possessing flufenacet resi dues. Risks are further plausible given flufenacet’s moderate persisten ce in terrestrial environments (half-lives ranging between 23.1 – 63.6 days).

Additional risks with broadleaf plan ts (not associated with crops) as well as short grass and long grass containing flufenacet residues are also possi ble with spray drift to areas containing grass offsite from the treated cultivated area. However, the exact contribution due to spray drift is not explicitly quantified in TREX. 0 10 20 30 40 50 60 70

Corn Forestry Soybeans Grass Seed Wheat and TriticaleRiskQuotients 

## Overall Contribution of Spray Drift on Vascular Aquatic Plant

Listed Species Risk Quotients for Flufenacet Uses

RQ's: Runoff and

Spray Drift

RQs: Runoff and

No Spray Drift

LOC

### Page 48 of 118 

### Birds

 Acute Risk (Oral-based)

Based on the submitted acute oral toxicity studies on birds and mammals, flufenacet is categorized as moderately toxic to birds on an acute oral basis. The LD 50 

### for the canary was determined to be 461 mg ai/kg bw (MRID 49844202). There were not any exceedances above the acute level of concern (0.5) for non-listed species. For listed species however, there were numerous RQs for small birds that exceeded the listed species LOC of 0.1. All proposed uses of flufenacet resulted in dose-based RQs that exceeded the endangered species LOC of 0.1 in small birds feeding on short grass and broadleaf plants. Medium sized birds feeding on short grass at all application rates, broadleaf plants at the two highest applicati on rates, and tall grass at the highest application rate, exceeded the listed species LOC as well ( Table 18 ).

While acute risk is determined by examining uppe r-bound residue levels, bird s exposed to residues at a magnitude comparable to mean residue levels left on food items woul d pose less risk to both

size classes of birds. At the tw o highest application rates, RQs de rived from mean residue levels do not exceed any LOCs for medium sized birds and only exceed th e listed species LOC for small birds for short grass and arthropods (RQ range fr om 0.11 and 0.17). At the two highest application rates, short grass residues woul d take roughly 33 and 41 days, and broadleaf plants 4 and 12 days, for the residues to drop below the Agency’s LOC for listed species.

 Chronic Risk (Dietary-based)

Chronic dietary risk was identified for birds cons uming short grass, tall gr ass and broadleaf plants at the highest application rates (RQs = 2.19, 1.0, 1.23 respectively). Risk was also identified from consumption of short grass from soybean an d grass seed applications (RQs 1.27 and 1.21 respectively) ( Table 20 ). These RQs are based on a reproduc tion study that shows increase in number of eggs cracked and decrease in normal hatchlings and survivors. Based on the toxic effects on birds and the RQs that exceed the LOC, chronic risk to birds exist when feeding around flufenacet application sites.

Mammals

 Acute Risk (Oral-based)

There was not any risk identified for non-listed ma mmals of any size. RQs did however exceed the listed species LOC for both small and medium sized mammals for the two highest application rates (ranging from 0.1 to 0.14) when consuming shor t grass. Examination of RQs that result from mean residues on these food items did not exceed any LOCs ( Table 19 ).

### Page 49 of 118 

###  Chronic Risk (Dietary-based)

Relative to the use patterns identifi ed in this assessment, exposure of flufenacet spray application is expected to result in chronic risk to mammals. As shown in Table 21 , most dose-based RQs for chronic risk to mammalian species are above th e chronic risk LOC (1) for all maximum spray application scenarios considered in this risk assessment (RQ range = 0.18 to 64.22). Specifically, chronic dose-based RQs exceed the LOC for mammals feeding on short grass (RQ range = 12.6 to 64.22), tall grass (RQ range = 5.8 to 29.43), br oadleaf plants (RQ range = 7.11 to 36.12), and fruits/pods (RQ range = 0.79 to 4.1), arthropods (RQ range = 4.95 to 25.2), and seeds (RQ range (0.18 to 0.89) for all modeled crop scenarios.

In addition, chronic dietary-based RQs exceed the chronic LOC for all modeled scenarios for mammals feeding on short grass (RQ range = 3.2 to 7.4), tall grass (RQ range = 1.5 to 3.4), and broadleaf plants (RQ range = 1.8 to 4.2) and arthropods (RQ range = 1.2 to 2.9). Mammalian RQs are based on a 2-generation repr oduction study that shows evidence of dose-related decreases in litter size, pup viabilit y, and pup body weight.

Based on the toxic effects on reproduction in mamma ls and the high RQ values, chronic risk to mammals from application of flufenacet is high, esp ecially since some of the proposed applications of flufenacet may occur during the spring/summer , coinciding with the reproductive season for

most animals.

In addition, the metabolite of flufenacet, thiadone, has been identified as toxic to mammals and birds. However, since thiadone has a short aer obic soil half-life (2.0-2.8 days) and is highly mobile, it may not be available to terrestrial anim als on a long-term basis, decreasing the chronic risk to these species.

To bound the estimates of risk to mammals and birds resulting from chronic exposure to flufenacet, RQs using mean Kenaga residue values in add ition to upper-bound values were calculated. Using the non-conservative mean residue values, impl ying that higher predicte d residue values are expected half the time, for all modeled scenarios, dose-based RQs for all sizes of mammals feeding on short grass, tall grass, and broadleaf plants (RQ range = 1.9 to 22.75) still exceed the chronic LOC; however, for mammals that feed on fruits /pods, there are fewer exceedances with mean residues (only for 15g and 35g mammals feeding on fruits/pods for the sweet corn modeled scenario and 15g mammals that feed on fruits/pods (RQ = 1.08) for the grass modeled scenario). There are also fewer exceedances for the dietary RQs for mammals with s hort grass and arthropods exceeding the chronic LOC for the third highest app lication rate and only short grass exceeding at the lowest application rate.

Piscivorous Birds and Mammals

There were no exceedances to piscivorous birds or mammals feeding on fish containing flufenacet

and thiadone residues. The result ing acute and chronic RQs are <0.01 for piscivorous birds. Acute RQs for piscivorous mammals was also <0.01 while chronic RQs for piscivorous mammals ranged from 0.02 to 0.2. Likely reasons for marginal impacts include flufenacet’s relatively low application rate and log K ow 

### 3.2 value indicating a marginal poten tial for flufenacet residues to

### Page 50 of 118 

### bind to fatty tissues. While BCF values are as high as 103X, 98 percent of flufenacet and other radioactive residues depurated within 15 da ys after exposure 103X (MRID Nos. 43441127 and 43441139).

Terrestrial Invertebrates

Results of the acute contact toxici ty studies with honey bees demons trate that flufenacet TGAI is practically non-toxic to benefici al insects on an acute basis (LD 50 

### > 25 μ g a.i./bee). RQs for acute risk are below 0.09 which is below the LOC of 0.4 ( Table 24 ). Therefore, non-target insects are at low risk through acute contact expo sure from application to flufenacet. However, there is a potential for indirect risk due to the hi gh toxicity of flufenacet to terrestrial plants. Many invertebrates rely on plants during a part of their life cycles. Data concerning chronic exposure to adult and larval honeybees as well as acute exposure to larval honeybees is also lacking so there is more uncertainty as to the risk from other exposure routes to flufenacet.

Terrestrial Plants

 Runoff and Spray Drift Exposure

Current terrestrial phytotoxicity data and the predicted expos ures from the TerrPlant model generally indicate that there is risk to non-listed and listed monocotand dicot terrestrial and semiaquatic plant species. Data from a Tier-2 vegetative vigor study indicate that the most sensitive monocot was sorghum with an EC 25 

### /NOAEC of 0.017/0.008 lbs a.i./A a nd the most sensitive dicot

was cucumber with an EC 25 

### /NOAEC of 0.032/0.016 lbs a.i./A. The calculated risk quotients for terrestrial and semi-aquatic plants do exceed th e level of concern for most listed and non-listed terrestrial plants in adjace nt areas and semi-aquatic ar eas (RQ range = 0.2 to 25.5; Tables 22 and

23 ), indicating risk to terrestrial plants.

To further analyze the potential risk from fluf enacet use to non-target plants, the AgDrift model was used to predict spray drift deposition, and to determine the distance from the edge of the

treated site where the risk from spray drift alone is equal to the LOC for listed and non-listed plants. It is important to recognize, though, that risk from runoff is not considered in this analysis. However, risk to plants from sp ray applications may also be re duced through the in corporation of spray drift buffers. In this analysis, the buffer di stances to where the spra y drift deposition fraction equals the vegetative vigor EC 25 

### for evaluating risk to non-listed plants as well as the distance where the spray drift deposition fraction equals th e vegetative vigor NOAEL for evaluating risk to listed plants are determined. Beyond these distances, the risk from sp ray drift alone is not expected

to exceed the LOC. Table 26 and Table 27 provide buffer distances for both monocots and dicots respectively using the default droplet size dist ributions in the AgDRIF T model for both ground and aerial applications (droplet sizes per the American Society of Agricultural and Biological Engineers or ASABE: very fine to fine for ground applications a nd fine to medium for aerial applications). This is done since flufenacet labe ls do not specify droplet size distributions. Ground applications are modeled with both high and lo w boom applications (1. 27 and 0.5 meters above the ground respectively).

For monocots, spray drift buffer distances that resulted from low boom gr ound applications ranged

### Page 51 of 118 

### from 20 feet for non-listed species at the lowest application rate, to 95 feet for listed species exposed to the highest application rates ( Table 26) . These spray drift buffer distances increase for high boom applications and ranged from 52 feet fo r non-listed species at the lowest application rate to 236 feet for listed species at the highest application rate. Spray drift buffer distances to mitigate risk for monocots from aerial applications were 374 and 988 feet for non-listed and listed species respectively (Table 26)

.

Table 26. Modeled spray drift buffer distances needed to mitigate risk to the most sensitive monocot species for applications with very fine to fine droplet size spectrum (ground applications) and fine to medium droplet size spectrum (aerial applications).

Use (application

rate - SPRAY DRIFT BUFFER DISTANCES

lbs a.i./A) Very Fine to Fine Droplet Spectrum Fine to Medium Droplet Spectrum

Ground High Boom Ground Low Boom Aerial (1.27 m height) (0.5 m height)

Nonlisted Listed Nonlisted Listed Nonlisted Listed

Corn (Sweet

and Field) 118 236 43 95 NA NA

-0.8019

Soybean 69 144 26 52 NA NA -0.4644

Grass Seed 66 138 26 49 NA NA

-0.442

Wheat &

Triticale (0.3448) 52 108 20 39 NA NA

MONOCOT EC 25 = 0.017 lbs. a.i./A; NOA EC = 0.008 lbs. a.i./A

*NA means not applicable since application method is not allowed for use as per product labels.



### For dicots, spray drift buffer distances that resulted from low boom gr ound applications ranged from 13 feet for non-listed species at the lowest application rate to 46 feet for listed species exposed to the highest application rates (Table 27) . These buffer distances increased for high boom applications and ranged from 30 feet for non-lis ted species at the lowest application rate to 125 feet for listed species at the highest applicati on rates. Spray drift buffer distances to mitigate risk for dicots from aerial applications were 200 and 400 feet for non-listed and listed species respectively (Table 27)

.

### Page 52 of 118 Table 27. Modeled spray drift buffer distan ces needed to mitigate risk to the most sensitive dicot species for applicat ions with very fine to fine droplet size spectrum (ground applications) and fine to medium droplet size spectrum (aerial ap plications).

Use (application

rate - lbs

a.i./A) SPRAY DRIFT BUFFER DISTANCES

Very Fine to Fine Droplet Size Spectrum Fine to Medium Droplet Size

Spectrum

Ground High

Boom Ground Low

Boom Aerial (1.27 m height) (0.5 m height)

Nonlisted Listed Nonlisted Listed Nonlisted Listed

Corn (Sweet

and Field) 66 125 23 46 NA NA

-0.8019

Soybean 39 72 13 26 NA NA -0.4644

Grass Seed 36 69 13 26 NA NA

-0.442

Wheat &

Triticale (0.3448) 30 56 13 20 NA NA

DICOT EC 25 = 0.032 lbs. a.i./A; NOAEC = 0.016 lbs. a.i./A

*NA means not applicable since application method is not allowed for use as per product labels.



### The AgDRIFT model was also run with the coar sest droplet sizes for both ground and aerial applications in order to evaluate spray drift bu ffer distances with larger droplet sizes which may be more common with pre-emergent herbicide app lications and to explore the narrowest buffers possible to mitigate the risks due to spray drift w ith the current flufenacet uses. The spray drift buffer distances required to mitigate risk for ground applications with fine to medium/coarse droplet sizes (D V0.5 

### droplet size = 341 microns) with a low boom range from 6.6 feet for non-listed monocot species to 36 feet for lis ted monocot species and the lowest and highest application rates respectively (Table 28) . The buffer distances required to mitigate risk for ground applications with a low boom range from 3.3 feet for non-listed di cot species to 16 feet for listed dicot species and the lowest and highest application rates respectively (Table 29).

. Tables 28 and 29 also provide buffer distances for a high boom scenario as well since labels often say to position height of boom for uniform coverage but to limit drift.

The spray drift buffer distance estimates provided in Tables 28 and 29 are the narrowest buffers that can be achieved assuming ad equately large spray droplets (D V0.5 

### droplet size of 341 micron droplets) and low enough boom heights for monocot s and dicots respectiv ely. The aerial spray buffer estimates assume the coarsest droplet si zes (mean droplet size of 450 microns). Spray

### Page 53 of 118 

### applications that use a finer droplet size in an y application will have significantly larger buffer distances in order to mitigate risk to non-target plants.

Table 28. Modeled spray drift buffer di stances needed to mitigate risk to the most sensitive monocot species fo r applications with fine to medium coarse droplet sizes (ground applications) and coarse to very coarse droplet sizes (aerial applications).

Use (application

rate - lbs a.i./A) SPRAY DRIFT BUFFER DISTANCES

Fine to Medium Coarse Droplet Size Spectrum Fine to Medium Droplet Size

Spectrum
Ground High

Boom (1.27 m height) Ground Low

Boom (0.5 m height) Aerial

Nonlisted Listed Nonlisted Listed Nonlisted Listed

Corn (Sweet

and Field) (0.8019) 26 66 16 36 NA NA

Soybean 13 33 10 20 NA NA -0.4644

Grass Seed 13 33 10 20 NA NA

-0.442

Wheat &

Triticale 10 23 7 13 NA NA

-0.3448

MONOCOT EC 25 = 0.017 lbs. a.i./A; NOA EC = 0.008 lbs. a.i./A

*NA means not applicable since application method is not allowed for use as per product labels.

### Page 54 of 118 Table 29. Modeled spray drift buffer di stances needed to mitigate risk to the most sensitive dicot species for app lications with fine to medium coarse droplet sizes (ground applications) and coarse to very coarse droplet sizes for (aerial applications).

Use (application

rate - lbs a.i./A) SPRAY DRIFT BUFFER DISTANCES

Fine to Medium Coarse Droplet Size Spectrum Fine to Medium Droplet Size

Spectrum

Ground High

Boom (1.27 m height) Ground Low

Boom (0.5 m height) Aerial

Nonlisted Listed Nonlisted Listed Nonlisted Listed

Corn (Sweet

and Field)

13 26 10 16 NA NA

-0.8019

Soybean 7 16 7 10 NA NA

-0.4644

Grass Seed 7 13 7 10 NA NA

-0.442

Wheat &

Triticale 7 10 3 7 NA NA

-0.3448

DICOT EC 25 = 0.032 lbs. a.i./A; NOAEC = 0.016 lbs. a.i./A

**NA means not applicable since application method is not allowed for use as per product labels.



### In general, it should be emphasized that the high est spray drift exposure and resulting buffer zones occur with flufenacet’s corn. Flufenacet is only applied via ground spray or surface applications for corn, but it possesses the highest maximum app lication rate (0.8019 lbs.a i./A). Buffer zones for ground spray are lower than buffer zones for corn as expected given its lower maximum application rate. These buffer zones only mitigate ri sk from spray drift and don’t take into account other exposure routes like runoff.

 Exposure from Application of Irrigation Water Containing Flufenacet Residues

There may also be risk to plants with applica tion of irrigation water ( both ground water and surface water) containing flufenacet residues given its herb icidal properties. Such exposure may occur

### Page 55 of 118 

### with flufenacet’s ability to tran sport to surface water and ground water sources via runoff, erosion, and leaching as demonstrated through various water monitoring studies as well as upper-bound estimated exposure in surface and ground water (see Table 17 . for the presentation on surface water exposure estimation using the SWCC and Appendix D for the presentation on ground water exposure estimation using PRZM-GW). For fl ufenacet, surface water EECs are higher than ground water. Therefore, peak EECs for flufenacet only in the surface water column as presented

in Table 17 (EEC = 17.4  g/L = 17.4 ppb, SWCC IL Corn Scenario) serves as the preliminary basis for deriving equivalent EECs to plants impact ed via this exposure occu rring associated with irrigation practices. To estimate exposure to plan ts when irrigation from surface water sources are contaminated with flufenacet, it was assumed that a field is irrigated with one acre-inch of water containing residues. One acre-in ch of irrigation water is e quivalent to 6,272,640 cubic inches. Therefore, a 1 acre field with 1 inch of water has 3,630 cubic ft , of water (6,272,640 cubic inches x 0.00058 cubic ft/cubic inch), which is equivalent to 27,156 gallons of water (3,630 cubic ft x 7.481 gallons/cubic ft). Therefore, 1 inch of water on the 1 acre field weighs 226,625 lbs (27,156 gallons x 8.3453 lbs/gallon of water). Hence, the estimated exposure concentration for terrestrial plants considering flufenacet upper-bound concentr ations found in surface water is given as

follows: Plant	EEC	 ቀ ୪ୠୱ.ୟ.୧.

୅ 

### ቁ ൌ SWCC	EEC ሺ ppb ሻ x	Conversion	factorሺ ୤୰ୟୡ୲୧୭୬

ଵ,଴଴଴,଴଴଴,଴଴଴ 

### ሻ	x	Water	Weight ୪ୠୱ.

୅ 

### =

17.4	ppb

1,000,000,000 x 226,625	lbs. H ଶ 

### O

A ۯܑ./ .܉ .ܛ܊ܔ	૝ૢ૜૙૙ .૙ ൌ

The resulting RQ based on the most-sensiti ve endpoint for monoc ots (RQ= EEC/NOAEC =

0.00394 lbs. a.i./A ÷ 0.00 80 lbs. a.i./A = 0.49 ) is below the LOC (LOC =1) for both listed and nonlisted plants. For dicots, the RQs are also belo w both LOCs based on its most sensitive endpoint (RQ= EEC/NOAEC = 0.00394 lbs. a. i./A ÷ 0.016 lbs. a.i./A = 0.26 ). In addition, it appears that risks are more certainly higher w ith the runoff and spray drift expos ure scenarios for plants based on the RQs (range of between 0.26 – 0.49) shown in this section above as compared to RQs (range of 1.5 – 22 for listed plants a nd 0.40 – 14.7) presented with sp ray drift and runoff exposure

examined in Section 5.1

.


## 5.2.3 Uncertainties, Assumptions, and Limitations

 Environmental Fate

The environmental fate database for flufenacet is complete with no major data gaps identified.

One source of uncertainty relate d to the behavior of flufenacet in the environment relates to unextractable residues observed in excess of 10 percent of applied over multiple soils in aerobic soil metabolism studies and multiple water-sediment systems in aerobic aquatic metabolism studies (refer to Appendix C which shows the distribution of a ll material from flufenacet applied in soil and water laboratory fate studies). Despite this uncertainty, this risk assessment did not

evaluate this unextracted residues as part of the consideration for total toxic residues. The overall risk conclusions are not likely to change accounti ng for this uncertainty given that risk quotients are very low for aquatic animals (acute RQs< 0.01, chronic RQs<0.48) which are all well below

### Page 56 of 118 

### the listed species LOCs, but much larger for aquatic plants resulting in ri sks of concern broadly with all uses aquatic plants, especially with listed species. This is consistent with flufenacet’s expected mode of action as an herbicide.

The second main uncertainty is re lated to the biodegradation of thia done in water. While relatively persistent, the half-lives for th iadone are determined to be great er than 160 days in the aerobic aquatic environment and 303 days in the anaer obic aquatic environm ent (MRID Nos. 45796111 and 45796110). Observed DT 50 

### s appeared to be close to those values in both studies. However, the source of uncertainty is related to incomple te material balances in both studies (below 90 percent of applied thiadone at some sampling inte rvals). However, this uncertainty is not very substantial considering that minimum material balances ranged between 83.9 – 76.6 percent of applied thiadone. Despite this uncertainty, the 1 60 day half-life value an d 303 day half-life value was input for the thiadone degradate into the SWCC ( Table 1 ). However, since these are long half-lives, and the uncertainty related to incomple te material balances is small, relatively small differences in thiadone exposure estimates are e xpected for acute (peak) and chronic (24-day and 60-day average) surface water con centrations if there was more certainty with these factors.

 Ecological Effects

The ecological effects data are largely complete. The majority of data gaps identified in the problem formulation have been submitted and clas sified as acceptable and are suitable for risk

assessment purposes.

 Aquatic Exposure

In general, upper-bound aquatic exposure estimate s for flufenacet and its thiadone degradate presented in this risk assessment likely accurately reflect where flufenacet is used with high certainty given its few registered uses and since its usage is confined to a specific area of the country. Flufenacet usage is confined to the corn and soybean belt of the Midwest, North Carolina, Southern High Plains, and Oregon.

Surface water upper-bound exposure estimates are generally higher by a large margin than the highest water monitoring concentr ations observed. This may be due to a wide number of factors relating to lower vulnerabilities with rainfall, runo ff, and drainage that ma y have been present at the surface water monitoring sites since the m odeling scenarios depict vulnerable sites. Furthermore, it is a likelihood that surface water monitoring are not sp atially or temporally targeted to applications especially as evident in thei r irregular sampling intervals in many cases.

However, it should be noted that there was one isol ated detection of flufen acet, identified in PDP data, at relatively high le vels of 75 ppb in finished water at a water treatment facility in Indiana in 2007. While this detection is higher in magn itude than the upper-bound EEC in surface water provided in this assessment (17.4 ppb, see Table 17 ); this flufenacet detection at 75 ppb is isolated and as such may be reflective of a distinctive se t of circumstances such as a high-end runoff event

which occurred in the area at the time of this det ection. It is uncertain whether this value would represent a one-in-ten year peak concentration given the relatively small temporal scope of the

### Page 57 of 118 

### monitoring data available for flufenacet. Howeve r, this detection in Indiana provides further evidence of flufenacet surface water exposure in an area where it is highly used.

 Terrestrial Exposure

Toxic response is a function of duration and inte nsity of exposure. For many compounds a gavage dose represents a very short-term high intensit y exposure. Although the dose-based estimates may not reflect reality in that animals do not receive a gavage while feeding, it is possible that a shortduration, high-intensity exposure could occur associat ed with feeding on an agricultural field since many birds may gorge themselves when food ite ms are available. While the dietary-based estimates may suggest greater “realism,” they too suffer from some uncertainties. Primarily, the dietary-based approach assumes that animals in th e field are consuming food at a rate similar to

that of confined laborat ory animals despite the fact that energy content in food items differs between the field and the laboratory as does the energy requirements of wild and captive animals.

Other uncertainties with flufenacet are related to the represen tativeness of T-REX with preemergent applications. Risks occurring indica ted by T-REX due to flufenacet residues on seeds or arthropods located with in treated fields are mo st certain with its pre- emergent applications. However, for risks related to broadleaf plants which may be a surrogate to crops, exposure may occur with the uptake of flufenacet residues in the soil as well as any re sidual residues that are remain in the plant system from the seed after germination. Howe ver, it should be noted that the extent to which flufenacet is systemic is unknow n. While a rough indicator, flufenacet’s log K ow 

### of 3.2 suggests some ability for flufenacet to remain within the plant material for some period of

time.

Furthermore, additional risks with non-crop broadleaf plants as well as with short grass and long grass containing flufenacet residues are also possi ble with spray drift to areas containing grass

offsite from the treated cultivated area. Ho wever, while T-REX would capture the upper-bound exposure in the treated field from these food items; the exact contribution due to spray drift is not explicitly quantified in T-REX.

 Uncertainty in Risk Conclusions

The EC 25 

### and NOAEC values, however, only assess the eff ects on initial plant growth and survival. EPA current tests do not provide information on e ffects to reproduction, fruit formation or fruit yield. However, it is currently assumed that a 25 percent or greater effect on initial plant growth is indicative of subsequent reductions on plant populations, fruit formation and yield. In addition, the number of laboratory test spec ies only account for eight of th e 300 known plant families. The range of sensitivity of various plants to a phyt otoxicant can be significantly higher than that exhibited in the laboratory because of intraspecies and interspecies variability, genetic differences in adaptability to environmental stresses, and magnitude and duration of exposure.



# 6. Endocrine Disruptor Screening Program

### Page 58 of 118 

### As required by FIFRA and FFDCA, EPA reviews nu merous studies to a ssess potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotox icity, developmental, reproductive, and general or systemic toxicit y. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocr ine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnanc y rates, reproductive loss, and sex ratios in offspring. For ecolo gical hazard assessments, EPA ev aluates acute tests and chronic studies that assess growth, devel opmental and reproductive effects in different taxonomic groups.

EPA has developed the EDSP to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered approach to maki ng the statutorily required determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potenti al of a chemical substance to interact with the estrogen, androge n, or thyroid (E, A, or T) horm onal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the availabl e data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by th e substance, and esta blish a dose-response relationship between the dose a nd the E, A, or T effect.

Under FFDCA section 408(p), the Ag ency must screen all pesticid e chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for th e first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredient s. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 

### and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be

construed as a list of known or likely endocrine disruptors.

Flufenacet is not among the group of 58 pesticide active ingredients receivi ng EDSP test orders.

For information on the status of the orders i ssued under the EDSP for each chemical, please visit our website at http://www.epa.gov/endo/ and click on the "Status of EDSP Orders/DCIs" in the Highlights Box. Additional info rmation on the EDSP, including th e policies and procedures, the list of 67 chemicals, the test guid elines and the Tier 1 screening battery, can al so be found at this

website.



# 7. Federally Threatened and Endangered (Listed) Species of
Concern

At this current stage of the Registration Review process, it is premature to make effects determinations for listed sp ecies until further scientific analysis and refinements are conducted,

based on recommendations received from the National Academy of Sciences’ (NAS) National Research Council (NRC) April 2013 report, available at

1 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

### Page 59 of 118 

### http://www.nap.edu/catalog.php?record_id=18344. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that are compliant with the En dangered Species Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The EPA along with the U.S. Fish & Wildlife Se rvice (USFWS), the National Marine Fisheries Service (NMFS) (collectively, the Services), a nd the U.S. Department of Agriculture (USDA), released a summary of their implementation plan for assessing risks of pestic ides to listed species ahead of the stakeholder workshop held on Nove mber 15, 2013. This plan was developed in response to the NAS’ recommendations, including a common approach to risk assessment as a way of addressing scientific di fferences between EPA and the Se rvices. During the workshop, the agencies received feedback from the public on the interim scientific approaches that were developed as part of the initial implementati on of the NAS recommendations. These approaches will be jointly implemented and vetted as part of a phased iterative process. Once fully vetted, EPA will further refine the listed species effects determination portion of this risk assessment.

To make effects determinations for individual listed species, us eful refinements may include, but are not limited to, analyses of: 1) more detaile d, species-specific ecological and biological data; 2)

more detailed and accurate information on flufenacet use patterns; and 3) sub-county level spatial proximity data for the co-occurrence of potential e ffects areas and listed species and any designated critical habitat. Examples of su ch refinements are described below.

EFED is currently developing tools that are exp ected to further refine the assessment and are designed to support effects determinations for individual federally lis ted species and their designated critical habitats (where applicable ). Scientific information obtained from the Services, and other reliable sources is being co llated by EFED to address all currently listed species. This information is being stored in an Office of Pesticide Programs (OPP) Pesticide Registration Information SysteM (PRISM) listed species knowledgebase. The listed species knowledgebase consists of an information repos itory that houses biological and behavioral information relevant to individual species (, habitat, diet, and life hi story, including specific temporal and spatial associations) and a documen t repository that contains supporting documents (e.g., USFWS recovery plans) and el ectronic information (, GIS data files). For terrestrial taxa, biological information relevant to the assessment ( e.g. , diet and body weight) will be used to parameterize exposure estimates using a method c onsistent with currently used methods in the TREX and T-HERPS models.

Refinements will also include mo re detailed analyses of the re gistered uses and specific use patterns that result in either “Likely to Advers ely Affect” (LAA) or “Not Likely to Adversely Affect” (NLAA) determinations for federally list ed species. The analyses may include more information on where, when, and how pirimiphos-met hyl is used on all use sites. Actual usage data (when available) and national land-cover data sets that indicate pot ential use sites [e.g., National Land Cover Dataset (NLCD), Cropland Da ta Layer (CDL)] may be used to support a more refined analysis of where flufenacet is reasonably expected to be used. Similarly, refinements on the timing of applications and a mo re in-depth exploration of agronomic practices for flufenacet may be included as part of the refinement.

### Page 60 of 118 

### The refinements based on individu al species data; additional, detailed usage information, when available; and recommendations from the NRC re port are expected to he lp to more accurately identify potential areas of effect and to better inform effects and habitat determinations for listed species and any designate d critical habitats.



# Conclusions

After reviewing the most recent environmental fate and effects data for flufenacet, the screeninglevel assessment concludes that registered uses of the herbicide may result in risk to both listed and non-listed species of aquatic plants and terrestrial plants and animals.

When estimates of flufenacet expos ure in terrestrial and aquatic environments are compared to the available ecotoxicity data, the results of the scr eening-level assessment indicate a potential for risk to both aquatic plant taxa and terrestrial plant an d animal taxa. There was not any risk identified for aquatic fish or invertebrates in either freshw ater or estuarine environments. Because risk to

water column invertebrates is low on both an acute and chronic basis when compared to both water column and porewater values and the low Koc of fl ufenacet indicates low partitioning to sediment particles, the risk to sediment dwelling organisms is presumed to be low as well. Risk above the

level of concern was identified for aquatic plants (both vascular a nd non-vascular) at all application rates. For the majority of uses, the risk remained whether or not spray drift was eliminated in order to mitigate risk.

Acute dose based risk to endangered birds was identified in all size classes of birds. Avian chronic RQs exceeded the LOC in for every scenario but wheat . Since the application of flufenacet occurs through both ground and aerial spray and residues can be transported to off-site food items there is likely to be both acute and chronic risk to birds. Acute risk to enda ngered mammals was only identified for the highest two application rates. Chronic risk however oc curred at all application rates with RQs that were substantially higher th an the level of concern for both dose-based and dietary based exposure. Therefor e while acute risk to mammals ex ists there is higher risk on a chronic basis to mammals feeding on food items lo cated around application sites. There was not any acute or chronic risk identified from the cons umption of fish contaminated with flufenacet. The available data suggest that flufenacet is practically non-toxic to bees and preliminary modeling and RQ analysis suggests that risk to bees is low. As an herbicide, there is substantial risk to both listed and non-listed offsite plants exposed to flufenacet. For ground a pplications with the remaining corn, soybean, wheat, and grass seed uses , buffer distances range from 6 feet to 236 feet depending on application rate, dr oplet size and boom height.

The overall risk conclusions for aquatic and terr estrial taxa broken down by each use of flufenacet are presented below in Table 30 and Table 31, respectively.Page 61 of 118Table 30. Summary of adverse impacts for aquatic organisms expected from the existing uses of flufenacet.Proposed Use(App. Rate -lbs. a.i./A)Adverse Impacts Expected for Aquatic Organisms? (No/Yes: A = Acute, C=Chronic)FreshwaterFishEstuarine/MarineFishEstuarine/MarineInvertebratesFreshwater andSaltwaterBenthicInvertebrates(Sediment)FreshwaterBenthicInvertebrates(Pore water)SaltwaterBenthicInvertebrates(Pore water)Aquatic PlantsFreshwaterInvertebrates(Water Column)(Water Column)Corn(Sweet andField)(0.8019)No No No No No No NoYesSoybean(0.4644)No No No No No No NoYesGrass Seed(0.442)No No No No No No NoYesWheat &Triticale(0.3448)No No No No No No NoYes*Risks identified applies for listed and non-listed aquatic plants for all uses.Page 62 of 118Table 31. Summary of adverse impacts for terrestrial organisms expected from the existinguses of flufenacet.Proposed Use(App. Rate -lbs. a.i./A)Adverse Impacts Expectedfor Terrestrial Organisms?(No/Yes: A = Acute, C=Chronic)BirdsMammalsPiscivorousBirdsPiscivorousMammalsTerrestrialPlantsTerrestrialInvertebratesCorn (Sweet andField)(0.8019)YesA,CYesA,CNo NoYesNoSoybean(0.4644)YesA,CYesCNo NoYesNoGrass Seed(0.442)YesA,CYesCNo NoYesNoWheat & Triticale(0.3448)YesAYesCNo NoYesNo*Risks identified applies for listed and non-listed terrestrial plants , and chronic risks to mammals and birds for all uses.Acute risks identified for only listedspecies for mammals and birds.

### Page 63 of 118 

# 8. References

CFR 40. 2007. Code of Federal Regulati ons 40 Parts 150 to 189. Protection of the Environment. U.S. Government Printing Office.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instru ment for estimating pesticide residues on plants. Environ. Tox. Chem. 13:1383-1391.

Hoerger, F. and E. E. Kenaga, 1972. Pesticide Re sidues on Plants: Correlation of Representative Data as a Basis for Estimation of their Magnit ude in the Environment. In F. Coulston and F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme Publ., Stuttg art, West Germany, pp. 9-28.

Teske, M. E., & Curbishley, T. B. 2003. AGDISP Version 8.07 User Manual . Prepared For United States Department of Agriculture Forest Serv ice. C.D.I. Technical Note No. 02-06. June

2003.

USEPA, 1998. Guidelines for Ecological Risk A ssessment. Risk Assessment Forum, Office of Research and Development, Washingt on, D.C. EPA/630/R-95/002F. April 1998. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759

USEPA, 2004 Overview of the Ecological Risk Assessment Process in th e Office of Pesticide Programs. U.S. Environmental Protection Ag ency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington DC. January 23, 2004.

USEPA, 2007a. Ecotoxicology (ECOTOX) database. Version 4. Office of Research and Development (ORD) , and the National Heal th and Environmental Effects Research Laboratory's (NHEERL's) Mid-Con tinent Ecology Division (MED). http://cfpub.epa.gov/eco tox/ecotox_home.cfm

USEPA, 2007b. Ecological Incident Information System (EIIS). Environmental Fate and Effects

Division.

USEPA, 2009. Guidance for Selecting Input Para meters in Modeling th e Environmental Fate and Transport of Pesticides. U.S. E nvironmental Protection Agency, Office of Prevention, Pesticides and Toxic Substa nces, Office of Pesticide Programs,

Environmental Fate and Effects Division. Nov. 10, 2009 Online at: http://www.epa.gov/oppefed1/models/w ater/input_parameter_guidance.htm

.

USEPA, 2010 Screening Level Estimates of Ag ricultural Uses on Flufenacet. Biological and Economic Assessment Division, Office of Pe sticide Programs. Dated June 6, 2010.

### Page 64 of 118 

### USEPA, 2014[a]. Surface Water Concentration Calculator User Manual, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division. July 1, 2014.

USEPA, 2014[b]. Guidance for Assessing Pesticid e Risks to Bees. USEPA Office of Pesticide Programs, Health Canada Pest Management Re gulatory Agency, California Department of Pesticide Regulation.

USEPA, 2014[c]. Guidance for Addressing Unex tracted Residues in Laboratory Studies. USEPA Office of Pesticide Programs.

U.S. Fish and Wildlife Service (USFWS) and Na tional Marine Fisheries Service (NMFS), 1998. Endangered Species Consultation Handbook: Procedures for Conducting Consultation

and Conference Activities Under Section 7 of the Endangered Sp ecies Act. Final Draft.

March 1998.

USGS, 2010. National water quality assess ment program. Accessed 2 November 2010. http://water.usgs.gov/nawqa/

.

### Page 65 of 118 

# Appendix A. Environmental Fate and Ecological Effects Data

for Flufenacet

PC Code 121903 Flufenacet Fate Chemistry Bibliography

161-1 Hydrolysis

MRID Citation Reference

43441134 Zeng, Z.; Wood, S. (1992) Stability of FOE 5043 in Sterile Aqueous Buffer Solution: Lab Project Number: F3072401: 102623. Unpublished study prepared by Miles Environmental Research. 25 p.

45796107 Shah, J.; Bloomberg, A. (1999) Hydrolysis Study of Thiadone (A Metabolite of FOE 5043): Lab Project Number: F3072402: 108719: 7410-98-0058-EF-001. Unpublished study prepared by Bayer Corporation. 76 p.



## 161-2 Photodegradation-water

MRID Citation Reference

43850003 Fontaine, L. (1995) Product Chemistry of FOE 5043 Technical: (Stability): Supplement to MRID 43441101: (Contains Data on Aqueous Photolysis of (carbon 14) Phenyl-U FOE 5043 and Photolysis of (carbon 14) Phenyl-U FOE 5043 on Sandy Loam): Lab Project Number: 106246: 106247: 107082. Unpublished study prepared by Bayer Corp. 157 p.

43850056 Kasper, A.; Shadrick, B. (1995) Aqueous Photolysis of (carbon 14)-Phenyl-U FOE 5043: Lab Project Number: F3082401: 106246: 92-B139. Unpublished study prepared by Bayer Corp. 79 p.



## 161-3 Photodegradation-soil

MRID Citation Reference

43850003 Fontaine, L. (1995) Product Chemistry of FOE 5043 Technical: (Stability): Supplement to MRID 43441101: (Contains Data on Aqueous Photolysis of (carbon 14) Phenyl-U FOE 5043 and Photolysis of (carbon 14) Phenyl-U FOE 5043 on Sandy Loam): Lab Project Number: 106246: 106247: 107082. Unpublished study prepared by Bayer Corp. 157 p.

### Page 66 of 118 43850057 Kasper, A.; Shadrick, B. (1995) Photolysis of (carbon 14)-U FOE 5043 on Sandy Loam: Lab Project Number: 106247: F3082101: F3082102. Unpublished study prepared by Bayer Corp. 68 p.

45796108 Lentz, N.; Bloomberg, A. (2001) Soil Photolysis of Thiadone on Loamy Sand (A Metabolite of FOE 5043): Lab Project Number: F3082103: 108721: 7410-98-0055-EF-001. Unpublished study prepared by Ricerca LLC. 54 p.



## 162-1 Aerobic soil metabolism

MRID Citation Reference

43441135 Pangilinan, N.; Smith, D. (1994) Aerobic Soil Metabolism of (Thiadiazole-2-(carbon 14))FOE 5043: Lab Project Number: F3042103: 106420. Unpublished study prepared by Miles Agriculture Division. 69 p.

43441141 Pangilinan, N.; Smith, D. (1994) Aerobic Soil Metabolism of (Phenyl-U- (carbon 14))FOE 5043: Lab Project Number: F3042102: 106408. Unpublished study prepared by Miles Agriculture Division. 89 p.

43850058 Kelley, I.; Wood, S.; McKinney, M. (1995) Degradation of (carbon 14)-U FOE 5043 in Three Soil Types: Lab Project Number: 106664: 92-B153: F3042104. Unpublished study prepared by Bayer Corp. 83 p.

43850066 Shadrick, S.; Kasper, A. (1995) Outdoor Soil Metabolism of (carbon 14)-Thiafluamide (FOE 5043) on California Soils: Lab Project Number:92183: 106210. Unpublished study prepared by Bayer Corp. and PanAgricultural Labs, Inc. 82 p.

45796109 Lentz, N.; Bloomberg, A. (1999) Rate of Aerobic Soil Degradation for Thiadone (A Metabolite of FOE 5043): Amended Report: Lab Project Number: 7410-98-0008-EF-001-001: F3042108: 108722. Unpublished study prepared by Ricerca Inc. 125 p.



## 162-2 Anaerobic soil metabolism

MRID Citation Reference

43850059 Pangilinan, N.; Smith, D. (1995) Anaerobic Soil Metabolism of (carbon 14)-U FOE 5043: Lab Project Number: 106645: F3042106: 94-B-225. Unpublished study prepared by Bayer Corp. 108 p.



## 162-3 Anaerobic aquatic metabolism

MRID Citation Reference

43850060 Pangilinan, N.; Smith, D. ( 1994) Anaerobic Aquatic Metabolism of

### Page 67 of 118 (carbon 14)-U FOE 5043: Lab Project Number: F3042402: 106439: 92-B-93. Unpublished study prepared by Bayer Corp. 89 p.

43850061 Pangilinan, N.; Smith, D. ( 1995) Anaerobic Aquatic Metabolism of (carbon 14)-Thiadiazole-2 FOE 5043: Lab Project Number: 106440: F3042403. Unpublished study prepared by Bayer Corp. 76 p.

45796110 Archer, G.; Korsch, B. (2001) Anaerobic Aquatic Metabolism of (Carbon-14) Thiadone, a Metabolite of FOE5043: Amended Report: Lab Project Number: 7410-98-0038-EF-001-001: F3042408. Unpublished study prepared by Ricerca LLC. 54 p.



## 162-4 Aerobic aquatic metabolism

MRID Citation Reference

44580203 Kelley, I.; Wood, S.; McKinney, M. (1995) Degradability and Fate of (Phenyl-UL-(carbon 14))Foe 5043 in Two Sediment/Water Systems: Lab Project Number: F3042405: 106928. Unpublished study prepared by Bayer Corporation. 83 p.

45796111 Archer, G.; Korsch, B. (2001) Aerobic Aquatic Soil Metabolism of (Carbon-14) Thiadone, a Metabolite of FOE5043: Lab Project Number: 7410-98-0039-EF-001: F3042407: 108723. Unpublished study prepared by Ricerca LLC. 55 p.

45796112 Halarnkar, P.; Irwin, D. (1 997) Aerobic Aquatic Metabolism of (Thiadiazole-2-(Carbon-14)) FOE 5043 in Two Water/Sediment Systems: Lab Project Number: F3042406: 107822. Unpublished study prepared by Bayer Corporation. 55 p.



## 163-1 Leach/adsorption/desorption

MRID Citation Reference

43441136 Kelley, I.; Wood, S. (1994) Leaching of Aged FOE 5043 Residues through Soil Columns: Lab Project Number: F3092101: 105014. Unpublished study prepared by Miles Research and Development Dept. 84 p.

43441137 Kelley, I.; Wood, S. (1992) Adsorption/Desorption of FOE 5043 to Soil: Lab Project Number: F3182101: 103903. Unpublished study prepared by Miles Research and Development Dept. 46 p.

43441138 Kelley, I.; Wood, S. (1993) Addendum to Miles Report No. 103903: Adsorption/Desorption of FOE 5043 to Soil: Lab Project Number: 103903/1. Unpublished study prepare d by Miles Research and Development Dept. 12 p.

43441140 Blumhorst, M.; Yen, P.; Marlow, V. (1994) Soil Adsorption/Desorption of FOE 5043 Degradates: FOE Sulfonic Acid, FOE Methyl Sulfoxide, FOE Oxalate, FOE Alcohol, and Thiadone: Lab Project Number:

### Page 68 of 118 F3182102: 122S19: 106598. Unpublis hed study prepared by EPL BioAnalytical Services, Inc. 122 p.



## 163-2 Volatility - lab

MRID Citation Reference

45796113 Korsch, B.; Malekani, K. (2000) Laboratory Volatilization of (Carbon14) Thiadone from Soil: Lab Project Number: 7410-98-0168-EF-001: F3152101: 108725. Unpublished study prepared by Ricerca, LLC. 53

p.



## 164-1 Terrestrial field dissipation

MRID Citation Reference

43850062 Wood, S.; Lam, C.; Leimkuehler, W. (1995) Terrestrial Field Dissipation of FOE 5043 in North Carolina Soil, 1993: Lab Project Number: 106641: F3022101: ETI-2007MZ01. Unpublished study prepared by Bayer Corp.; Environmental Technologies Institute, Inc.; and Alta Analytical Labs. 185 p.

43850063 Wood, S.; Lam, C.; Leimkuehler, W. (1995) Terrestrial Field Dissipation of FOE 5043 in Wisconsin Soil, 1993: Lab Project Number: CR9312: F3022103: 106643. Unpublished study prepared by Bayer Corp.; Agstat; and Alta Analytical Lab, Inc. 173 p.

43850064 Leimkuehler, W.; Moore, K. (1994) Analytical Method for the Determination of FOE 5043 and Six Metabolites in Soil: Lab Project Number: F3112101: 106917. Unpublished study prepared by Miles, Inc. 53 p.

43850065 Leimkuehler, W.; Moore, K. ( 1994) Supplemental to the Analytical
Method for the Determination of FOE 5043 and Six Metabolites in Soil: Lab Project Number: F3112101: 106917-1. Unpublished study prepared by Miles, Inc. 19 p.

43850066 Shadrick, S.; Kasper, A. (1995) Outdoor Soil Metabolism of (carbon 14)-Thiafluamide (FOE 5043) on California Soils: Lab Project Number:92183: 106210. Unpublished study prepared by Bayer Corp. and PanAgricultural Labs, Inc. 82 p.



## 165-1 Confined rotational crop

MRID Citation Reference

### Page 69 of 118 43441133 Lenz, M.; McKinney, M. (1994) Accumulation of (Phenyl-(carbon 14)) FOE 5043 Residues in Confined Rotational Crops: Lab Project Number: F3051601: 106768. Unpublished study prepared by Miles Research and Development Dept. 87 p.

43850069 Halarnkar, P.; Mennicke, E. (1995) Accumulation of (Thiadiazole-2- (carbon 14)) FOE 5043 Residues in Confined Rotational Crops: Lab Project Number: F3051602: 106639. Unpublished study prepared by Bayer Corp. 54 p.



## 165-2 Field rotational crop

MRID Citation Reference

44253101 Krolski, M. (1997) Replies to Comments and Questions from the EPA Concerning the Metabolism of and the Analytical Methodology Used for FOE 5043: Lab Project Number: 107737. Unpublished study prepared by Bayer Corp. 22 p.

44253103 Krolski, M. (1997) FOE 5043 60 DF--Magnitude of the Residue in Field Rotational Crops: (Final Report): Lab Project Number: 107703: F319RC01: BMS-F3028-94R. Unpubl ished study prepared by Bayer Corp. 1123 p.



## 165-4 Bioaccumulation in fish

MRID Citation Reference

43441127 Gagliano, G. (1994) Uptake, Depuration and Bioconcentration of (carbon 14)-FOE 5043 Technical by Bluegill (Lepomis macrochirus) under Flow-Through Conditions: Lab Project Number: F3030301: 106760. Unpublished study prepared by Miles Environmental Research Section. 41 p.

43441139 Leimkuehler, W.; Moore, K. ( 1994) Identification of Radioactive Residues of Phenyl-(carbon 14)FOE 5043 in Bluegill Sunfish (Lepomis macrochirus): Lab Project Number: F3040301: 106577. Unpublished study prepared by Miles Research and Development Dept. 59 p.



## 166-1 Ground water-small prospective

MRID Citation Reference

45737901 Dyer, D. (2002) Progress Report--July, 2002 FOE 5043 (AXIOM)-- Small-Scale Prospective Ground-W ater Monitoring Study, Corn in Nebraska, 1995: Lab Project Number: F3212402: 200257. Unpublished study prepared by Bayer Corp. 211 p.

### Page 70 of 118 45907901 Dyer, D.; Wood, S.; Helfrich , K. (2001) FOE 5043 (Flufenacet)--SmallScale Prospective Gro und-Water Monitoring St udy, Janesville, Iowa, 1995: Lab Project Number: F3212401: 94401: 1396. Unpublished study prepared by Bayer Corporation and Stone Environmental, Inc. 425 p.

46997402 Dyer, D.; Helfrich, K. (2005) Flufenacet (FOE 5043) -- Small-Scale Prospective Ground-Water Monito ring Study, Minden, Nebraska, 1995. Project Number: F3212402, 004/03548/00, 1397. Unpublished study prepared by Bayer Corp., LFR Levine-Fr icke, Inc. and Alta Analytical Laboratories. 542 p.



## 835.6100 Terrestrial field dissipation

MRID Citation Reference

48897601 Leimkuehler, W.; Bethem, R.; Peterson, R. (1995) Determination of FOE 5043 and Four Metabolites in Soil by High Performance LiquidChromatography Electrospray Tandem Mass Spectrometry (LCESI/MS/MS). Project Number: 1069 64. Unpublished study prepared by Alta Analytical Laboratories. 20p.

48897602 Bruns, G.; Hoshowski, J. (1998) Independent Laboratory Validation of Analytical Method AMFOE2 for the Analysis of Soil for FOE 5043 and Four Metabolite Residues. Project Number: F3112106, 98BA04/REP, 108145/MO/99/013955. Unpublished study prepared by Enviro-Test Laboratories (ETL). 90p.



## 835.6200 Aquatic field dissipation

MRID Citation Reference

48897603 Bethem, R.; Peterson, R.; Leimkuehler, W. et al. (1995) Determination of FOE 5043 and the Alcohol, Oxalate, Thiadone and Sulfonic Acid Metabolites in Groundwater by High Performance LiquidChromatography Electrospray Tandem Mass Spectrometry (LCESI/MS/MS). Project Number: AMFOE3 107138. Unpublished study prepared by Alta Analytical Laboratories. 22p.

48897604 Bruns, G.; Hoshowski, J. (1998) Independent Laboratory Validation of Analytical Method AMFOE3 for the Analysis of Groundwater for FOE

5043 and Four Metabolit e Residues. Project Number: 98BAY05/REP, F3112402, 108265. Unpublished study prepared by Enviro-Test Laboratories (ETL). 85p.



## Non Guideline Selections

44580202 Yen, P.; Kasper, A.; Pangilinan, N. (1997) Fate of FOE 5043 in the Environment (Updated Summary,1997): Lab Project Number: 107720.

### Page 71 of 118 Unpublished study prepared by Bayer Corporation. 84 p.

45796105 MacGregor, J.; Nixon, W. (1998) Analytical Method Verification for the
Determination of the Thiadone Metabolite of FOE 5043 in Saltwater: Lab Project Number: 149C-105: 108335. Unpublished study prepared by Wildlife International Ltd. 32 p. In conjunction with Estuarine Toxicity Studies?

43850068 Lin, H., D.L. Green, and P.S. Fig (1995) Freezer storage stability of [phenyl UL-14C] FOE 5043 in soil. Project # F3132101. Unpublished study performed and submitted by Miles, Inc., Kansas City, MO.

43850067 Lin, H., D.L. Green, and P.S. Fig (1995) Freezer storage stability of seven metabolites 14C FOE 5043 in soil. Project # F3132102. Unpublished study performed and submitted by Miles, Inc., Kansas City, MO.

D201249 Memo on Metabolite determination



## PC Code 121903 Flufenacet Eco Effects Bibliography

71-1 Avian Singl e Dose Oral Toxicity

MRID Citation Reference

43441113 Stafford, T. R. (1992) FOE 5043 Technical: An Acute Oral LD50 With Bobwhite Quail (Colinus virginianus) ID No. 106583. Laboratory: Miles Incorporated Agriculture Division. Research and Development Department, Environmental Research, Stilwell, Kansas. Sponsor: Miles Incorporated Agricultural Division, Kansas City, MO.

44246801 Downs, K.; Hancock, G. (1997) FOE 5043 Technical: An Acute Oral LD50 with Mallards: (Final Report): Lab Project Number: 107700: F3710801. Unpublished study prepared by Bayer Corp. 32 p.



## 71-2 Avia n Dietary Toxicity

MRID Citation Reference

43441114 Toll, P. (1994) FOE 5043 Technical: A Subacute Dietary LC50 with Northern Bobwhite: Lab Project Number: F3721701: 106583. Unpublished study prepared by Miles Environmental Research Section. 48 p.

43441115 Stafford, T. (1993) FOE 5043 Technical: A Subacute Dietary LC50

### Page 72 of 118 with Mallard Duck: Lab Project Number: F3720801: 103814. Unpublished study prepared by Miles Environmental Research Section. 37 p.



## 71-3 Wild mammal toxicity

MRID Citation Reference

44476901 Fairbrother, A.; Hancock, G. (1998) Dietary Toxicity (LC50) of FOE 5043 with Deer Mice (Peromyscus maniculatus): Lab Project Number:
BFOE5043DM-1-97: F3733901: 1078 26. Unpublished study prepared by Ecological Planning and Toxicology, Inc. 97 p.



## 71-4 Avian Reproduction

MRID Citation Reference

43441119 Schmuck, R. (1994) Effects of a Subchronic Dietary Exposure of FOE 5043 Tech. on Bobwhite Quail Including Effects on Reproduction and Health: Laboratory: Bayer AG Crop Protection Research Center Monheim, Institute for Environmental Biology D-51368 Leverkusen. Lab Project Number: F3741701: 106764. Unpublished study prepared by Bayer AG Institute for Environmental Biology. 162 p.

43441120 Hancock, G.; Reynolds, M . (1994 ) Effect of Technical FOE 5043 on Mallard Reproduction: Lab Project Number: F3740801: 106594. Unpublished study prepared by Miles Environmental Research. 121 p.

43441120 G.A. Hancock & M.L. Reynolds (1993 ) Effect of Technical FOE 5043 on Mallard Reproduction. Laboratory: Bayer Corporation (formerly Miles, Inc.) Agricultural Division Research and Development Department Environmental Research, Stilwell, Kansas, Sponsor: Bayer Corporation Agricultural Division, Kansas City , Missouri. Laboratory Report ID:

106594



## 72-1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

### Page 73 of 118 43441116 Gagliano, G.; Roney, D. (1994) Acute Toxicity of FOE 5043 Technical to the Bluegill (Lepomis macrochirus) under Flow-through Conditions: Lab Project Number: F3810301: 106558. Unpublished study prepared by Miles Environmental Research Section. 36 p.

43441117 Gagliano, G.; Bowers, L. (1994) Acute Toxicity of FOE 5043 Technical to the Rainbow Trout (Oncorhynchus mykiss) under Flow-through Conditions: Lab Project Number: F3812201: 106572. Unpublished study prepared by Miles Environmental Research Section. 36 p.

43595501 Bowers, L. (1995) Acute Toxicity of FOE 5043 Technical to the Bluegill (Lepomis macrochirus) Under Static-Renewal Conditions: Lab Project Number: 106674: F3810302. Unpublished study prepared by Miles, Inc. 31 p.

43850007 Bowers, L.; Frank, J. (1995) Acute Toxicity of FOE 5043 Technical to the Rainbow Trout (Oncorhynchu s mykiss) Under Static-Renewal Conditions: Lab Project Number: F3812202: 106673. Unpublished study prepared by Miles Inc. Agricultural Division. 31 p.

45796101 Hall, A.; Lam, C. (1999) Acute Toxicity of Thiadone, a Metabolite of FOE 5043, to the Bluegill (Lepomis ma crochirus): Lab Project Number: F3810901: 108455. Unpublished study prepared by Bayer Corporation. 33 p.

45796102 Bowers, L.; Lam, C. (1998) Acute Toxicity of Thiadone to the Rainbow Trout (Oncorhynchus mykiss) Unde r Static Conditions: Lab Project Number: 108738: F3812203. Unpublished study prepared by Bayer Corporation. 33 p.



## 72-2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

43441118 Bowers, L. (1994) Acute Toxicity of FOE 5043 Technical to the Waterflea (Daphnia magna) under Static Conditions: Lab Project Number: F3820701: 106579. Unpublished study prepared by Miles Environmental Research Section. 27 p.

43595503 Bowers, L. (1995) Acute Toxicity of FOE 5043 Technical to the Hyalella azteca Under Flow-Through Conditions: Lab Project Number: 106908: F3823201. Unpublished study pr epared by Miles, Inc. 33 p.

45796103 Bowers, L.; Lam, C. (1998) Acute Toxicity of Thiadone (a Metabolite of FOE 5043) to the Waterflea Daphnia magna Under Static Conditions: Lab Project Number: F3820702: 108464. Unpublished study prepared by Bayer Corporation. 32 p.



## 72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

### Page 74 of 118 43441121 Wheat, J. (1993) Acute Toxicity of FOE 5043 (Technical) to the Mysid (Mysidopsis bahia): Lab Project Number: J9208007B: 105180: F3832001. Unpublished study prepar ed by Toxikon Environmental Sciences. 50 p.

43441122 Gagliano, G.; Bowers, L. (1994) Acute Toxicity of FOE 5043 to the Sheepshead Minnow (Cyprinodon variegatus) under Static Renewal Conditions: Lab Project Number: F3832801: 106421. Unpublished study prepared by Miles Environmental Research Section. 31 p.

43441123 Wheat, J.; Evans, J. (1993) Acute Effect of FOE 5043 (Technical) on New Shell Growth of the Eastern Oy ster (Crassostrea virginica): Lab Project Number: J9201017B: 105181: F3821501. Unpublished study prepared by Toxikon Environmental Sciences. 49 p.

45796104 Bowers, L.; Lam, C. (1999) Acute Toxicity of Thiadone to the Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions: Lab Project Number: F3832802: 108809. Unpublished study prepared by Bayer Corporation. 32 p.

45796106 Palmer, S.; Krueger, H. (1998) Thiadone Metabolite of FOE 5043: A 96 Hour Flow-Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab Project Number: 149A-113: 108488. Unpublished study prepared by Wildlife International Ltd. 46 p.



## 72-4 Fish Early Life Stage/ Aquatic Invertebrate Life Cycle Study

MRID Citation Reference

43441124 Wheat, J. (1994) FOE 5043 Technical: Chronic Toxicity to the Mysid, Mysidopsis bahia, under Flow-Thr ough Test Conditions: Lab Project Number: J9310003: 106574. Unpublished study prepared by Toxikon Environmental Sciences. 68 p.

43441125 Gagliano, G. (1994) Early Life Stage Toxicity of FOE 5043 Technical to the Rainbow Trout (Oncorhynchus mykiss) under Flow-Through Conditions: Lab Project Number: F3842201: 106761. Unpublished study prepared by Miles Environmental Research Section. 73 p.

43441126 Gagliano, G.; Bowers, L. (1994) Chronic Toxicity of FOE 5043 Technical to the Waterflea (Daphnia magna) under Static Renewal Conditions: Lab Project Number: F3840701: 106762. Unpublished study prepared by Miles Environmental Research Section. 65 p.

43595502 Davis, J. (1995) Chronic Toxi city of FOE 5043 Technical to the Mysid Shrimp (Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: 106675: J9405004. Unpublished study prepared by Toxikon Environmental Sciences. 70 p.

43795301 Gagliano, G. (1995) Early Life Stage Toxicity of FOE 5043 Technical to the Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions: Lab Project Number: 106978: F3842202. Unpublished study prepared by Bayer Corp. 82 p.

### Page 75 of 118 45796114 Palmer, S.; Krueger, H. (1998) Thiadone Metabolite of FOE 5043: A 96 Hour Flow-Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab Project Number: 149A-113: 108488. Unpublished study prepared by Wildlife International Ltd. 46 p.



## 72-5 Fish Full Lifecycle Test

45796114 Hall, A.; Lam, C. (2002) Fathead Minnow (Pimephales promelas) Fish Life Cycle Test with Flufenacet (FOE 5043 Technical): Lab Project Number: F3851201: 109767. Unpublished study prepared by Bayer Corporation. 262 p.



## 72-6 Aquatic org. accumulation

MRID Citation Reference

43441127 Gagliano, G. (1994) Uptake, Depuration and Bioconcentration of (carbon 14)-FOE 5043 Technical by Bluegill (Lepomis macrochirus) under Flow-Through Conditions: Lab Project Number: F3030301: 106760. Unpublished study prepared by Miles Environmental Research Section. 41 p.



## 123-1 Seed germination/seedli ng emergence and vegitative vigor

MRID Citation Reference

43465002 Johns, C. (1994) Tier 2 Seed Germination, Seedling Emergence, and Vegetative Vigor Nontarget Phytot oxicity Study Using FOE 5043: Lab Project Number: 106780: F3201601. Unpublished study prepared by Miles, Inc. 188 p.



## 123-2 Aquatic plant growth

MRID Citation Reference

43441128 Gagliano, G. (1994) Acute Toxicity of FOE 5043 Technical to the Green Alga (Selenastrum capricornutum): Lab Project Number: F3881401: 106763. Unpublished study prepared by Miles Environmental Research Section. 36 p.

43441129 Gagliano, G. (1994) Acute Toxicity of FOE 5043 Technical to the Diatom (Navicula pelliculosa): Lab Project Number: F3881603: 106756. Unpublished study prepared by Miles Environmental Research Section. 34 p.

43441130 Gagliano, G. (1994) Acute Toxicity of FOE 5043 Technical to the

### Page 76 of 118 Marine Diatom (Skeletonema costatum): Lab Project Number: F3881402: 106751. Unpublished study prepared by Miles Environmental Research Section. 35 p.

43441131 Hughes, J.; Alexander, M. (1993) Acute Toxicity of FOE 5043 (Technical) to Anabaena flos-aquae: Lab Project Number: B059/022/1: 105199. Unpublished study prepared by Malcolm Pirnie Inc. 43 p.

43441132 Hughes, J.; Alexander, M. (1993) Acute Toxicity of FOE 5043 (Technical) to Lemna gibba G3: Lab Project Number: B059/022/2: 105198. Unpublished study prepared by Malcolm Pirnie Inc. 42 p.

43834401 Bowers, L.; Dobbs, M. (1995) Acute Toxicity of (carbon 14)-FOE 5043 Technical to the Freshwater Diatom (Navicula pelliculosa): Lab Project Number: 107113: F3883401. Unpublished study prepared by Bayer Corp. 34 p.

43834402 Bowers, L. (1995) Acute Toxicity of (carbon 14)-FOE 5043 Technical to the Green Alga Selenastrum capricornutum: Lab Project Number: 107114: F3883501. Unpublished study prepared by Bayer Corp. 33 p.

43834403 Bowers, L. (1995) Acute Toxicity of (carbon 14)-FOE 5043 Technical to the Marine Diatom Skeletonema costatum: Lab Project Number: 107115: F3883601. Unpublished study prepared by Bayer Corp. 34 p.

43834403 Bowers, L. (1995) Acute Toxicity of (carbon 14)-FOE 5043 Technical to the Marine Diatom Skeletonema costatum: Lab Project Number: 107115: F3883601. Unpublished study prepared by Bayer Corp. 34 p.

43850050 Dobbs, M. (1995) Data Analysis Correction for the Acute Toxicity of FOE 5043 Technical to the Diatom (Navicula pelliculosa): Amended Report: Lab Project Number: F3881603: 106756-1. Unpublished study prepared by Bayer Corp. 20 p.

43850051 Dobbs, M. (1995) Data Analysis Correction for the Acute Toxicity of FOE 5043 Technical to the Marine Diatom (Skeletonema costatum): Amended Report: Lab Project Number: F3881402: 106751-1. Unpublished study prepared by Bayer Corp. 20 p.

43850052 Dobbs, M. (1995) Data Analysis Correction for the Acute Toxicity of FOE 5043 Technical to the Green Alga (Selenastrum capricornutum): Amended Report: Lab Project Number: F3881401: 106763-1. Unpublished study prepared by Bayer Corp. 22 p.

45796115 Hall, A.; Lam, C. (1999) Toxicity of (Carbon-14)-Thiadone, a Metabolite of FOE 5043, to the Green Alga, Selenastrum capricornutum: Lab Project Number: F3883502: 108823. Unpublished study prepared by Bayer Corporation. 33 p.



## 141-1 Honey bee acute contact

MRID Citation Reference

43465001 Mayer, D. (1994) FOE 5043/H oney Bees Acute Toxicity: Lab Project

Number: 94-002: 106765: F3772901. Unpublished study prepared by Washington State University. 21 p.

### Page 77 of 118 44112201 Mayer, D. (1996) FOE 5043/Honey Bees Acute Toxicity: (Final Report): Lab Project Number: F3712901: 107517: WSU 96-001. Unpublished study prepared by Wash ington State University. 23 p. 

## 850.1035 Mysid acute toxicity test

MRID Citation Reference

49119001 Claude, M.; Martin, K.; Gallagher, S.; et al. (2013) Flufenacet: A 96- Hour Static Acute Toxicity Test wi th the Saltwater Mysid (Americamysis bahia). Project Number: EBFOL242, 149A/248 M/452205/01/1. Unpublished study prepared by Wildlife International, Ltd. 58p.



## 850.1350 Mysid chronic toxicity test

MRID Citation Reference

49119002 Claude, M.; Martin, K.; Gallagher, S.; et al. (2013) Flufenacet: A Flowthrough Life-Cycle Toxicity Test wi th the Saltwater Mysid (Americamysis bahia). Project Number: 149A/246, EBFOL243, M/452207/01/1. Unpublished study prepared by Wildlife International, Ltd. 121p.



## 850.1400 Fish early-life stage toxicity test

MRID Citation Reference

4924420

1 Banman, C.; Alexander, T.; Moore, S. (2013) Early Life Stage Toxicity of Flufenacet Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under Flow-Through Conditions. Project Number: EBFOL244, M/464909/01/1. Unpublishe d study prepared by SynTech Research Laboratory Services, LLC. 102p. Relates to L0001608.



## 850.2100 Avian acute or al toxicity test

MRID Citation Reference

49244202 Christ, M. (2013) Toxicity of Flufenacet Technical During an Acute Oral LD50 with the Canary (Serinus canaria): Final Report. Project Number: 07SRLS13C5, EBFOL245. Unpublished study prepared by SynTech

### Page 78 of 118 Research Laboratory Services, LLC. 47p. Relates to L0001608.



## 850.4225 Seedling emergence, Tier II

MRID Citation Reference

48897605 Friedrich, S. (2005) Flufen acet SC 500: Seedling Emergence and Seedling Growth Test on Terrestrial Non-target Plants: Final Report. Project Number: 04/10/48/104, MO/05/006018. Unpublished study prepared by Biochem Agrar, Labor fuer Biologische und Chemische. 108p.

48897606 Pallett, K.; Gosch, H. (2006) Flufenacet & Isox aflutole WG 58: Effect on Ten Species of Non-target Terr estrial Plants: Seedling Emergence and Seedling Growth Test (Tier 2). Project Number: SE/05/041 EBFOX1171. Unpublished study prepared by Bayer CropScience GmbH. 162p.

48897607 Pallett, K.; Gosch, H. (2006) Flufenacet & Isoxaflutole SC 480 (AE F133402 01 SC40 A401): Effect on Ten Species of Non-target Terrestrial Plants: Seedling Emergence and Seedling Growth Test (Tier 2). Project Number: SE/05/059, EBFOX131. Unpublished study prepared by Bayer CropScience GmbH. 176p.

48897608 Bowers, L. (2000) Tier 2 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Us ing Axiom 58 DF. Project Number: 109592, AX451602, AX451601. Unpublis hed study prepared by Bayer CropScience. 99p



## 850.4250 Vegetative vigor, Tier II

MRID Citation Reference

48897608 Bowers, L. (2000) Tier 2 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Us ing Axiom 58 DF. Project Number: 109592, AX451602, AX451601. Unpublis hed study prepared by Bayer CropScience. 99p.

48897609 Friedrich, S. (2005) Flufenacet SC 500: Vegetative Vigor Test on Nontarget Terrestrial Plants: Final Report. Project Number: 04/10/48/105/MO/05/006019, 04/10/ 48/105. Unpublished study prepared by Biochem Agrar, Labor fuer Biologische und Chemische. 93p.

48897610 Pallett, K.; Gosch, H. (2006) Flufenacet & Is oxaflutole WG 58: Effects on Ten Species of Non-target Terres trial Plants: Vegetative Vigor Test (Tier 2). Project Number: VV/05/042 EBFOX116. Unpublished study prepared by Bayer CropScience GmbH. 130p.

48897611 Pallett, K.; Gosch, H. (2006) Flufenacet & Isoxaflutole SC 480 (AE F133402 01 SC40 A401): Effects on Ten Species of Non-target Terrestrial Plants: Vegetative Vigor Test (Tier 2). Project Number:

### Page 79 of 118 VV/05/060, EBF0X132. Unpublished study prepared by Bayer CropScience GmbH. 131p.



## Non-Guideline Studies

MRID Citation Reference

43850006 Toll, P. (1995) Residues of FOE 5043 on Avian Forage and the Availability of Forage Plants in Corn Fields: Lab Project Number: F3762301: 42497: 107101. Unpublished study prepared by Bayer Corp. Agricultural Division. 56 p.

43948801 Heimbach, F. (1995) Toxicity of FOE 5043 T (Tech.) to Earthworms: Lab Project Number: 107310: E 310 0870-9: HBF/RG 202. Unpublished study prepared by Bayer AG. 22 p.

44246800 Bayer Corp. (1997) Submission of Hazard to Wildlife Data in Support

of FIFRA 6(a)(2) for FOE 5043 ( Thiafluamide ). Transmittal of 1 Study.

46400701 Bloomberg, A. (2004) Tier 3 Acute and Chronic Dietary Exposure Assessments for Flufenacet. Project Number: 201169. Unpublished study prepared by Bayer CropScience LP. 65 p.

48648901 Blanck, M. (2011) Flufenacet (FOE5043) Comp arative Thyroid Sensitivity Assay in the Rat by Dietary Exposure: (Gestational and Lact ational Exposure Phase). Unpublished study prepared by Bayer CropScience. 16p.

48648902 Blanck, M. (2011) Flufenacet (FOE5043) Comp arative Thyroid Sensitivity Assay in the Rat: Complementary Assay: (Gavage Exposure Phas e). Unpublished study prepared by Bayer CropScience. 12p.

48898903 Blanck, M. (2012) Flufenacet (FOE5043) - Co mparative Thyroid Sensitivity Assay in the Rat by Dietary Exposure (Gestational and Lact ational Exposure Phase). Project Number: M/435313/01/1/OCR, SA/11052, LYNX/PSI/N/TXF OX035. Unpublished study prepared by Bayer CropScience. 1056p

48898906 Gomez, C. (2011) Flufenacet - Determinat ion by High Performance Liquid Chromatography Analysis in Ground Rodent Diet. Project Number: M/426082/01/2/OCR, SA/11357. Unpublished study prepared by Bayer CropScience. 20p.

48898907 Tahmasseb, A. (2011) Flufenacet - Stabilit y in Aqueous 0.5 Percent Methylcellulose 400. Project Number: M/418123/01/2/OCR, SA/11177. Unpublished study prepared by Bayer CropScience. 17p.

### Page 80 of 118 

# Appendix B. Status of Environmental Fate and Ecological
Effects Studies for Flufenacet

Table B-1. Available envi ronmental fate data and study classifi cation for flufenacet and thiadone degradate.

Chemical No: 121903 FLUFENACET DATA REQUIREMENTS FOR THE

ENVIRONMENTAL FATE AND EFFECTS DIVISION

Data Requirements Composition 1 Use

Pattern 2 Bibliographic

Citation Study Classification

158.290 ENVIRONMENTAL FATE Degradation Studies – Lab:

161-1 Hydrolysis PAIRA

Thiadone 1 and 2

1 and 2 43441134

45796107 Acceptable Supplemental

161-2 Photolysis in Water PAIRA

Thiadone 1 and 2 43850056

46997401 Acceptable

Acceptable

161-3 Photolysis in Soil PAIRA

Thiadone 1 and 2

1 and 2 43850057

45796108 Acceptable Supplemental

Metabolism Studies – Lab:

162-1 Aerobic Soil

Metabolism PAIRA

PAIRA

PAIRA

Thiadone 1 and 2

1 and 2

1 and 2

1 and 2 43441141

43441135

43850058

45796109 Acceptable Acceptable Supplemental Supplemental

162-2 Anaerobic Soil

Metabolism PAIRA (degradate) 1 and 2 43850059 Supplemental

162-3 Anaerobic Aquatic

Metabolism PAIRA

PAIRA

Thiadone 1 and 2

1 and 2

1 and 2 43850060

43850061

45796110 Acceptable Acceptable Supplemental

162-4 Aerobic Aquatic

Metabolism PAIRA

Thiadone 1 and 2

1 and 2 45796112

44580203

45796111 Acceptable Supplemental

Acceptable Mobility Studies:

163-1 Adorption (unaged) PAIRA

Thiadone 1 and 2

1 and 2 43441137

43441140 Acceptable Acceptable 163-1 Leaching (aged) PAIRA 1 and 2 43441136 Supplemental 163-2 Laboratory volatility Thiadone 1 and 2 45796113 Supplemental 163-3 Field Volatility PAIRA 1 and 2 None submitted Dissipation Studies - Field:

164-1 Terrestrial Field Dissipation

ECM/ILV in soil TEP (DF) TEP (DF) 1 and 2

1 and 2 43850062

43850063

43850064

43850065 Acceptable Acceptable

Invalid Supplemental

Accumulation Studies:

165-4 Fish

Bioaccumulation PAIRA 1 and 2 43441127

43441139 Acceptable

Ground Water Monitoring Studies:

### Page 81 of 118 Table B-1. Available envi ronmental fate data and study classifi cation for flufenacet and thiadone degradate.

Chemical No: 121903 FLUFENACET DATA REQUIREMENTS FOR THE

ENVIRONMENTAL FATE AND EFFECTS DIVISION

Data Requirements Composition 1 Use

Pattern 2 Bibliographic

Citation Study Classification

166-1 Small Scale Prospective Groundwater Study

ECM/ILV in water TEP (DF) 1 and 2 45907901 (in Iowa)

46997402 (in

Nebraska)

45796105 (seawater) Acceptable

Acceptable

Acceptable

Notes:

1. Composition: PAIRA=Pure active ingredient, radiolabeled; TEP=Typ ical end-use Product.

2. Use Patterns: 1 = Terrestrial /Food; 2 = Terrestrial/Feed.

TableB-2. Ecological effects data and study classifications for flufenacet .

Guideline # Data Requirement Test Substance MRID # or

Citation Study Classification

850.2100 Avian Oral LD 50 TGAI 43441113

44246801

49244202

44246801 Acceptable Supplemental

Acceptable

Supplemental

850.2200 Avian Dietary LC 50 TGAI

TGAI 43441114

43441115 Acceptable Acceptable

850.2300 Avian Reproduction TGAI

TGAI 43441119

43441120 Acceptable Acceptable

850.1075 Freshwater Fish LC 50 TGAI

TGAI

TGAI

TGAI 43441116

43595501

43441117

43850007 Acceptable Acceptable Acceptable Acceptable

850.1010 Freshwater

Invertebrate Acute

LC 50 TGAI

TGAI 43441118

43595503 Supplemental Acceptable

850.1075 Estuarine/Marine Fish

LC 50 TGAI 43441122 Acceptable

850.1025 Estuarine/Marine

Mollusk EC 50 TGAI 43441123 Acceptable

850.1035

850.1045

850.1055

850.1075 Estuarine/Marine Shrimp EC 50 TGAI 43441121

49119001 Supplemental Acceptable

### Page 82 of 118 TableB-2. Ecological effects data and study classifications for flufenacet .

Guideline # Data Requirement Test Substance MRID # or

Citation Study Classification

850.1400 Freshwater Fish Early Life-Stage TGAI 43441125

43795301 Invalid Acceptable

850.1400 Estuarine/Marine Fish Early Life-Stage TGAI 4924420 1 Acceptable

850.1300 Aquatic Invertebrate Life-Cycle (freshwater) TGAI 43441126 Acceptable

850.1350 Aquatic Invertebrate Life-Cycle (marine) TGAI 43595502 43441124 49119002 Supplemental Supplemental

Acceptable

850.1500 Fish Full Life-Cycle TGAI 45796114 Supplemental

850.4225 Seedling Emergence (Tier II) 61% 43465002 Acceptable

850.4250 Vegetative Vigor (Tier II) 61% 43465002 Acceptable

850.4400

850.5400 Aquatic Plant Growth (Tier II) TGAI 43441132

43441128

43850052

43834402

43441130

43850051

43834403

43441129

43850050

43834401

43441131

45796115 (thiadone)

48897612 (thiadone) Acceptable

Invalid Acceptable Acceptable

Invalid Acceptable Acceptable

Invalid Acceptable Acceptable Acceptable Acceptable Supplemental

Acceptable

850.3020 Honey Bee Acute

Contact LD 50 TGAI 44112201

43465001 Acceptable

Invalid

850.3030 Honey Bee Residue on Foliage No data submitted NA

### Page 83 of 118 TableB-2. Ecological effects data and study classifications for flufenacet .

Guideline # Data Requirement Test Substance MRID # or

Citation Study Classification

870.1100 Acute Oral Toxicity

to Rat TGAI

TGAI +

Metribuzin 43441104

43441105 Acceptable Acceptable

870.3100 Subchronic Mammal TGAI 43743401

43738101

43619401 Acceptable Acceptable Acceptable

870.3700 Prenatal Developmental Toxicity Study - Rat TGAI 43850030 Acceptable

870.3800 Mammalian Reproduction -- Rat TGAI 3850033 Acceptable

*NA means not applicable

1 Thiadone is a major degradate of flufenacet, to which aquatic plants are likely to be exposed due to the persistence and mobility of thiadone.84Appendix C. Formation and Decline of Flufenacet MetabolitesTable C-1. Flufenacettransformation productsTransformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsAerobic Soil MetabolismTransformation Product 1Thiadone5-(Trifluoromethyl)-1,3,4-thiadiazol-2(3H)-oneor5-Trifluoromethyl-1,3,4-thiadiazol-2(3H)-oneor3-Trifluoromethyl-1,3,4-thiadiazol-2(3H)one3.9% @ 7 d 0.9% @ 368 d 43441135162-1Thiadiazole label/sandy loamAnaerobic Aquatic Metabolism16.0% @ 99 d 16.0% @ 99 d43850061162-3Thiadiazole label/pond watersandy loamAerobic Aquatic Metabolism84.3% @ 55 d 68.7% @ 156 d45796112162-4Thiadiazole label/pond watersilty clay sediment (NESA; entiresystem)63.8% @ 100 d 54.2% @ 156 d45796112162-4Thiadiazole label/pond watersilty clay loam sediment (BRP;entire system)Field Dissipation StudiesBelow LOD (<0.01 ppm)throughout studyBelow LOD (<0.01 ppm)@ 554 d43850062164-1North Carolina loamy sand (0-6inches)Below LOD (<0.01 ppm)throughout studyBelow LOD (<0.01 ppm)@ 466 d43850063164-1Wisconsin loamy sand (0-6inches)85Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsProspective Ground Water StudyBelow the LOQ (10 μg/kg)throughout the studyBelow the LOQ (10μg/kg) at 489 d45907901166-1Sandy loam (0-6 inches)Transformation Product 2Flufenacet methylsulfide4-Fluoro-N-methylethylanalinemethylthioacetamideAerobic Aquatic Metabolism11.4% @ 157 d 11.4% @ 157 d44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entire)4.5% @ 157 d 4.5% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)86Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 3Flufenacet oxalate[(4-Fluorophenyl)(1-methylethyl)]amino]oxoacetic acidor[(4-Fluorophenyl)(1-methylethyl)]amino]2-oxoacetic acidSoil Photolysisirradiated- 0.6% @ 30 ddark- 4.6% @ 30 dirradiated- 0.6% @ 30 ddark- 4.6% @ 30 d43850057161-3Phenyl label/sandy loamAerobic Soil Metabolism26.5% @ 365 d 26.5% @ 365 d43441141162-1Phenyl label/sandy loam6.6% @ 28 d Not detected @ 120 d 43850058162-1Phenyl label/loamy sand15.6% @ 28 dNot detected @ 120 d 43850058162-1Phenyl label/silt loam(Laacherhof)10.0% @ 28 d Not detected @ 120 d 43850058162-1Phenyl label/silt loam (Hofchen)13.0% @ 46 d11.7% @ 88 d 43850066162-1Phenyl label/fine sandy loam7.6% @ 88 d 7.6% @ 88 d 43850066162-1Phenyl label/sandy loamAnaerobic Soil Metabolism14.5% @ 60 d9.9% @ 210 d 43850059162-2Phenyl label/sandy loam87Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsAerobic Aquatic Metabolism4.6% @ 157 d 4.6% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)5.4% @ 157 d 5.4% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)Terrestrial Field Dissipation0.1 ppm @ 5 and 369 d Below LOD (<0.01 ppm)@ 554 d43850062164-1North Carolina loamy sand (0-6inches)0.01 ppm @ 27 and 369 d Below LOD (<0.01 ppm)@ 466 d43850063164-1Wisconsin loamy sand (0-6inches)88Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 4Flufenacet sulfonic acid4-Fluoro-N-methylethylaniline-sulfoacetamideorN-Fluoro-N-methylethylaniline-sulfoacetamideor2-[(4-Fluorophenyl)(1-methylethyl)amino]-oxoethylsulfonic acidSoil Photolysisirradiated- 0.4% @ 15 ddark- 2.2% @ 30 dirradiated- 0.3% @ 30 ddark- 2.2% @ 30 d43850057161-3Phenyl label/sandy loamAerobic Soil Metabolism7.7% @ 180 d 5.3% @ 365 d 43441141162-1Phenyl label/sandy loam25.4% @ 100 d 22.6% @ 120 d43850058162-1Phenyl label/loamy sand26.3% @ 100 d 21.8% @ 120 d43850058162-1Phenyl label/silt loam(Laacherhof)13.5% @ 100-120 d 13.5% @ 120 d43850058162-1Phenyl label/silt loam (Hofchen)2.4% @ 88 d 2.4% @ 88 d 43850066162-1Phenyl label/fine sandy loam1.3% @ 88 d 1.3% @ 88 d 43850066162-1Phenyl label/sandy loamAnaerobic Soil Metabolism6.6% @ 30 d 4.5% @ 210 d 43850059162-2Phenyl label/sandy loam89Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsAerobic Aquatic Metabolism1.65% @ 157 1.65% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; wateronly)3.2% @ 157 d 3.2% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)Terrestrial Field DissipationBelow LOD (<0.01 ppm)throughout studyNot analyzed @ 554 d 43850062164-1North Carolina loamy sand (0-6inches)0.02 ppm @ 14 to 27 d Below LOD (<0.01 ppm)@ 466 d43850063164-1Wisconsin loamy sand (0-6inches)Prospective Ground WaterBelow the LOQ (10 μg/kg)throughout the studyBelow the LOQ (10μg/kg) at 489 d45907901166-1Sandy loam (0-6 inches)Transformation Product 5Flufenacet methylsulfoxide4-Fluoro-N-methylethylanalinemethylsulfenylacetamideSoil Photolysisirradiated- 0.7% @ 30 ddark- 0.6% @ 30 dirradiated- 0.7% @ 30 ddark- 0.6% @ 30 d43850057161-3Phenyl labelAerobic Soil Metabolism0.6% @ 28 d Not detected @ 365 d 43441141162-1Phenyl label/sandy loam90Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberComments1.1% @ 28-56 d Not detected @ 120 d 43850058162-1Phenyl label/loamy sand3.5% @ 56 d 0.7% @ 120 d 43850058162-1Phenyl label/silt loam(Laacherhof)1.5% @ 56 d 0.2% @ 120 d 43850058162-1Phenyl label/silt loam (Hofchen)1.3% @ 88 d 1.3% @ 88 d 43850066162-1Phenyl label/fine sandy loam0.9% @ 88 d 0.9% @ 88 d 43850066162-1Phenyl label/sandy loamAerobic Aquatic Metabolism3.2% @ 157 d 3.2% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)2.2% @ 120 d 1.7% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)91Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 6Flufenacet methylsulfoneN-(fluorophenyl)-N-(1-methylethyl)-2-(methylsulfonyl)acetamideor4-Fluoro-N-methylethylanilinemethylsulfonylacetamideAerobic Soil Metabolism6.6% @ 100 d 4.7% @ 120 d 43850058162-1Phenyl label/loamy sand4.3% @ 120 d 4.3% @ 120 d 43850058162-1Phenyl label/silt loam(Laacherhof)5.6% @ 120 d 5.6% @ 120 d 43850058162-1Phenyl label/silt loam (Hofchen)0.5% @ 46 d 0.3% @ 88 d43850066162-1Phenyl label/fine sandy loamAerobic Aquatic Metabolism6.4% @ 100 d 5.3% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)7.2% @ 120 d 3.8% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)92Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 7Flefenacet thioglycolate sulfoxide4-Fluoro-N-methylethyl-anilinesulfenyldiacetic acid amideAerobic Soil Metabolism3.7% @ 180 d 2.8% @ 365 d 43441141162-1Phenyl label/sandy loam3.3% @ 56 d Not detected @ 120 d 43850058162-1Phenyl label/loamy sand5.5% @ 28 d Not detected @ 120 d 43850058162-1Phenyl label/silt loam(Laacherhof)1.9% @ 28 d Not detected @ 120 d 43850058162-1Phenyl label/silt loam (Hofchen)Anaerobic Soil Metabolism2.6% @ 30 d Not detected @ 210 d 43850059162-2Phenyl label/sandy loamAerobic Aquatic Metabolism2.0% @ 157 d 2.0% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)1.89% @ 60 d 1.38% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)93Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 8Flufenacet alcoholN-(4-fluorophenyl)-2-hydroxyacetamideorN-(4-Fluorophenyl)-2-hydroxy-N-(1-methylethyl)acetamideSoil Photolysisirradiated- 1.0% @ 30 ddark- 0.4% @ 30 dirradiated- 1.0% @ 30 ddark- 0.4% @ 30 d43850057161-3Phenyl labelAerobic Soil Metabolism2.1% @ 44-65 d Not detected @ 365 d 43441141162-1Phenyl label/sandy loam8.1% @ 88 d 8.1% @ 88 d 43850066162-1Phenyl label/fine sandy loam21.2% @ 88 d 21.2% @ 88 d43850066162-1Phenyl label/sandy loamAnaerobic Soil Metabolism1.4% @ 153 d 0.9% @ 210 d 43850059162-2Phenyl label/sandy loamAerobic Aquatic Metabolism0.7% @ 120 d 0.6% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)1.3% @ 157 d 1.3% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)94Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTerrestrial Field Dissipation0.4 ppm @ 1 d Below LOD (<0.01 ppm)@ 554 d43850062164-1North Carolina/Pocalla loamysand0-6 inches0.01 ppm @ 1 to 14 d Below LOD (<0.01 ppm)@ 466 d43850063164-1Wisconsin/ Dickinson sandy loam0-6 inchesProspective Ground WaterBelow the LOQ (10 μg/kg)throughout the studyBelow the LOQ (10μg/kg) at 489 d45907901166-1Transformation Product 9Flufenacet chloroacetanilideN-(4-Fluorophenyl)-2-chloro-N-(1-methylethyl)acetamideAerobic Soil Metabolism5.1% @ 44 d Not detected @ 365 d 43441141162-1Phenyl label/sandy loam0.4% @ 1 d 0.2% @ 88 d 43850066162-1Phenyl label/fine sandy loam0.4% @ 27 d 0.2% @ 88 d 43850066162-1Phenyl label/sandy loam95Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 10Flufenacet N-isomerN-(4-Fluorophenyl)-N-(1-methylethyl)-5-oxo2-(trifluoromethyl)-1,3,4-thiadiazole-4(5H)-acetamideSoil Photolysisirradiated- 1.6% @ 8-15 ddark- 1.8% @ 15 dirradiated- 1.6% @ 30 ddark- 1.5% @ 30 d43850057161-3Phenyl labelAerobic Soil Metabolism2.0% @ 46 d 0.7% @ 88 d 43850066162-1Phenyl label/fine sandy loam1.4% @ 88 d 1.4% @ 88 d 43850066162-1Phenyl label/sandy loamTransformation Product 11Flufenacet thiol dimer2,2'-Dithiobis[N-(4-fluorophenyl)-N-(1-methylethyl)acetamide]Aerobic Soil Metabolism0.8% @ 27 d 0.7% @ 88 d 43850066162-1Phenyl label/fine sandy loamTransformation Product 12Flufenacet thioglycolate4-Fluoro-N-methylethylaniline thiodiaceticacid amideAnaerobic Soil Metabolism1.7% @ 60 d1.4% @ 210 d 43850059162-2Phenyl label/sandy loam96Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 13Flufenacet amine acetateN-(4-Fluorophenyl)-N(1-methylethyl)acetamideAnaerobic Aquatic Metabolism1.6% @ 63-91 d 1.6% @ 91 d 43850060162-3Phenyl label/pond water-sandyloamTransformation Product 14Thiadone-acetate5-Trifluoromethyl-1,3,4-thiadiazol-2-oxyacetic acidAnaerobic Aquatic Metabolism1.8% @ 99 d1.8% @ 99 d43850061162-3Thiadiazole label/pond watersandy loamTransformation Product 15FAIOCS and Flufenacet acidCysteine conjugate of 4'Fluoro-Nisopropanolacetanilide and FOE oxalateFish BCF0.258 mg/kg @ 21 d (nonedible)0.191 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill (Lepomismacrochirus)Transformation Product 16FACSO3-[[2-4-[(4-Fluorophenyl)(1-methylethyl)amino]2-oxoethyl]sulfinyl]analineFish BCF0.327 mg/kg @ 21 d (nonedible)0.114 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill (Lepomismacrochirus)97Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 17FANACSON-Acetyl-3-[[2-[4-fluorophenyl)(1-nethylethyl)amino]-2-oxoethyl]sulfinyl]alanineFish BCF0.444 mg/kg @ 21 d (nonedible)0.097 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill (Lepomismacrochirus)Transformation Product 18FOE GSHN-[2-(Carboxmethyl)amino]-1-[[[[2-[(4-fluorophenyl)(1-methylethyl)amino]-2-oxoethyl]thio]methy]-2-oxoethyl]glutamineFish BCF0.355 mg/kg @ 21 d (nonedible)0.239 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill (Lepomismacrochirus)Transformation Product 19FACSS-[2-[(4-Fluorophenyl)(1-methylethyl)amino]-2-oxoethyl]cysteineFish BCF5.719 mg/kg @ 28 d (nonedible)5.719 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill sunfish(Lepomis macrochirus)0.692 mg/kg @ 21 d(edible)0.631 mg/kg @ 28 d(edible)43441127/43441139165-4Phenyl label/bluegill sunfish(Lepomis macrochirus)98Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsTransformation Product 20FANACSNacetyl-S-[2-[(4-fluorophenyl)(1-methylethyl)amino]-2-oxoethyl]cysteineFish BCF2.431 mg/kg @ 28 d (nonedible)2.431 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill sunfish(Lepomis macrochirus)0.326 mg/kg @ 21 d(edible)0.260 mg/kg @ 28 d(edible)43441127/43441139165-4Phenyl label/bluegill sunfish(Lepomis macrochirus)Transformation Product 21Flufenacet GLUFish BCF0.52 mg/kg @ 21 d (nonedible)0.467 mg/kg @ 28 d(non-edible)43441127/43441139165-4Phenyl label/bluegill sunfish(Lepomis macrochirus)Carbon dioxideAerobic Soil Metabolism50.9% @ 368 d 50.9% @ 368 d43441135162-1Thiadiazole label/sandy loam5.9% @ 365 d 5.9% @ 365 d 43441141162-1Phenyl label/sandy loam14.2% @ 120 d 14.2% @ 120 d43850058162-1Phenyl label/loamy sand99Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberComments23.8% @ 120 d 23.8% @ 120 d43850058162-1Phenyl label/silt loam(Laacherhof)12.0% @ 120 d 12.0% @ 120 d43850058162-1Phenyl label/silt loam (Hofchen)Anaerobic Soil Metabolism1.8% @ 210 d 1.8% @ 210 d 43850059162-2Phenyl label/sandy loamAnaerobic Aquatic Metabolism0.1% @ 91 d 0.1% @ 91 d 43850060162-3Phenyl label/pond water-sandyloam soil1.4% @ 99 d 1.4% @ 99 d 43850061162-3Thiadiazole label/pond watersandy loam soilAerobic Aquatic Metabolism3.4% @ 157 d 3.4% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA; entiresystem)1.5% @ 157 d 1.5% @ 157 d 44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP; entiresystem)15.3% @ 156 d 15.3% @ 156 d45796112162-4Thiadiazole label/pond watersilty clay sediment (NESA; entiresystem)100Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberComments15.0% @ 156 d 15.0% @ 156 d45796112162-4Thiadiazole label/pond watersilty clay loam sediment (BRP;entire system)Unextracted residuesAerobic Soil Metabolism17.7% @ 271 d 16.5% @ 365 d43441141162-1Phenyl label/sandy loam6.9% @ 270 d 6.5% @ 368 d 43441135162-1Thiadiazole label/sandy loam24.4% @ 19 d 19.5% @ 88 d43850066162-1Phenyl label/fine sandy loam25.3% @ 88 d 25.3% @ 88 d43850066162-1Phenyl label/sandy loam42.3% @ 120 d 42.3% @ 120 d43850058162-1Phenyl label/loamy sand37.1% @ 120 d 37.1% @ 120 d43850058162-1Phenyl label/silt loam(Laacherhof)58.0% @ 120 d 58.0% @ 120 d43850058162-1Phenyl label/silt loam (Hofchen)Anaerobic Soil Metabolism32.6% @ 210 d 32.6% @ 210 d43850059162-2Phenyl label/sandy loam101Transformation Product Name andStructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final samplinginterval (Interval)Study andGuidelinenumberCommentsAnaerobic Aquatic Metabolism10.0% @ 63 d6.0% @ 91 d 43850060162-3Phenyl label/pond water-sandyloam soil0.6% @ 64-99 d 0.6% @ 99 d 43850061162-3Thiadiazole label/pond watersandy loam soilAerobic Aquatic Metabolism28.5% @ 157 d 28.5% @ 157 d44580203162-4Phenyl label/pond water-silty clayloam sediment (NESA)46.4% @ 157 d 46.4% @ 157 d44580203162-4Phenyl label/pond water-silty clayloam sediment (BRP)3.3% @ 55 d 2.2% @ 156 d 45796112162-4Thiadiazole label/pond watersilty clay sediment (NESA)9.6% @ 100 d 7.5% @ 156 d 45796112162-4Thiadiazole label/pond watersilty clay loam sediment (BRP)102Table C-2. Thiadone as the TestMaterial transformation products.Transformation ProductName and StructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final sampling interval(Interval)Study andGuidelinenumberCommentsTransformation Product 1Propionic acid conjugate ofthiadoneSoil Photolysisirradiated- 6.1% @ 10 ddark- 12.0% @ 7 dirradiated- 2.9% @ 14 ddark- 2.1% @ 14 d45796108161-3Loamy sand soilAerobic Soil Metabolism10.2% @ 2 d 0.1% @ 10 d 45796109162-1Loamy sand7.0% @ 2 d 0.1% @ 10 d 45796109162-1Sandy loam1.3% @ 1 d Not detected @ 14 d 45796109162-1Silt loamCarbon DioxideSoil Photolysisirradiated- 57.8% @ 14 ddark- 57.6% @ 14 dirradiated- 57.8% @ 14 ddark- 57.6% @ 14 d45796108161-3Loamy sand soilAerobic Soil Metabolism63.2% @ 10 d 63.2% @ 10 d45796109162-1Loamy sand82.1% @ 10 d 82.1% @ 10 d45796109162-1Sandy loam71.8% @ 14 d 71.8% @ 14 d45796109162-1Silt loamAnaerobic Aquatic Metabolism1.9% @ 303 d 1.9 % @ 303 d 45796110162-3Water-silty clay sediment (entire system)103Transformation ProductName and StructureMaximum Percent ofApplied Dose (Interval)Percent of Applied Doseat final sampling interval(Interval)Study andGuidelinenumberCommentsAerobic Aquatic Metabolism10.9% @ 160 d 10.9% @ 160 d 45796111162-4Water-silty clay sediment (entire system)Unextractable residuesAerobic Soil Metabolism20.1% @ 7 d 19.5% @ 10 d45796109162-1Loamy sand8.4% @ 5 d 7.6% @ 10 d 45796109162-1Sandy loam14.7% @ 7-14 d 14.7% @ 14 d45796109162-1Silt loamAnaerobic Aquatic Metabolism3.0% @ 61 d 0.8 % @ 303 d 45796110162-3Water-silty clay sediment (entire system)Aerobic Aquatic Metabolism2.4% @ 160 d 2.4% @ 160 d 45796111162-4Water-silty clay sediment (entire system)

### 104 

# Appendix D. Sample SWCC and PRZM-GW Files

Figure D-1. Sample SWCC output file (IL Corn).



# Summary of Water Modeling of Fl ufenacet_ILCorn and the USEPA

Standard Pond

Estimated Environmental Concentrations for Fluf enacet_ILCorn are presented in Table 1 for the USEPA standard pond with the ILCornSTD field s cenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface & Ground

Water Concentration Calculator Version 1.14. Critical input values for the model are

summarized in Tables 2 and 3.

This model estimates that about 2.1% of Fluf enacet_ILCorn applied to the field eventually reaches the water body. The main m echanism of transport from the field to the water body is by runoff (59.3% of the total transport), followe d by spray drift ( 29%) and erosion (11.7%). In the water body, pesticide dissipates with an effective water column half-life of 168.7 days. (This value does not include di ssipation by transport to the be nthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective averag e half-life = 168.9 days) followed by volatilization (155961.1 days). In the benthic region, pesticide dissipation is negligible (1077. 7 days). The main source of dissipation in the benthic region is metabolism (effective average half -life = 1077.7 days). The vast majority of the pesticide in the benthic region (97.91%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentr ations (ppb) for Flufenacet_ILCorn.

Peak (1-in-10 yr) 17.4

4-day Avg (1-in-10 yr) 17.0

21-day Avg (1-in-10 yr) 16.3

60-day Avg (1-in-10 yr) 14.6

365-day Avg (1-in-10 yr) 7.70

Entire Simulation Mean 5.17

Table 2. Summary of Model Inputs for Flufenacet_ILCorn.

Scenario ILCornSTD

Cropped Area Fraction 1

Koc (ml/g) 434.4

Water Half-Life (days) @ 25 °C 77.1

### 105 Benthic Half-Life (days) @ 25 °C 492

Photolysis Half-Life (days) @ 45

°Lat 0

Hydrolysis Half-Life (days) 0

Soil Half-Life (days) @ 25 °C 48.2

Foliar Half-Life (days) 0

Molecular Wt 363.6

Vapor Pressure (torr) 2.11e-7

Solubility (mg/l) 56

Table 3. Application Schedul e for Flufenacet_ILCorn.

Date (Days

Since Emergence) Type Amount (kg/ha) Eff. Drift

-15 Ground 0.898 0.99 0.062

Figure 1. Yearly Peak Concentrations

### 106 Figure D-2. Sample PRZM-GW output file (WI Sands).

Table 1. Groundwater Results for Flufenacet _WISands and the Wisconsin Corn - WI

Central Sands Scenario.

Peak Concentration (ppb) 12.4

Post-Breakthrough Mean Concentration (ppb) 11

Entire Simulation Mean Concentration (ppb) 4.12

Average Breakthrough Time (days) 8188.552

Throughputs 1.338454

Table 2. Chemical Propertie s for Groundwater Modeling of Flufenacet_WISands.

Koc (ml/g) 434.4

Surface Soil Half Life (days) 48.2

Hydrolysis Half Life (days) 0

Diffusion Coefficint Air (cm2/day) 0.0

Henry's Constant 0.0

Enthalpy (kcal/mol) 0.0

Table 3. Pesticide application scheme used for Flufenacet_WISands. This application scheme was applied every year of the simulation.

Application Days

Relative to Emergence Date (05/01) Application Method Application Rate

(kg/ha)

-15 All pesticide placed at 5.08 cm

below surface 0.898

### 107 Figure 1. Aquifer Breakthrough Curve for Fluf enacet_WISands and the Wisconsin Corn -

WI Central Sands Scenario

### 108 

# Appendix E. Sample TREX Files

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flufenacet

Use 118

Formulation 0

Application Rate 0.8019 lbs a.i./acre

Half-life 35 days

Application Interval 0 days

Maximum # Apps./Year 1

Length of Simulation 1 year
Variable application rates? 0.00



## Endpoints



# Avian Canary LD50 (mg/kg-bw) 461.00

Bobwhite quail LC50 (mg/kg-diet) 0.00

Mallard duck NOAEL(mg/kg-bw) 0.00

Mallard duck NOAEC (mg/kg-diet) 88.00



# Mammals LD50 (mg/kg-bw) 589.00
LC50 (mg/kg-diet) 0.00
NOAEL (mg/kg-bw) 1.30
NOAEC (mg/kg-diet) 26.00 

# Dietary-based EECs

(ppm) Kenaga

Values

Short Grass 192.46

Tall Grass 88.21 Broadleaf plants 108.26 Fruits/pods/seeds 12.03
Arthropods 75.38

Avian Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI

Class Weight (g) (g bw/day) (g/day) consumed (kg-diet/day)

### 109 Small 20 5 23 114 2.28E-02

Mid 100 13 65 65 6.49E-02
Large 1000 58 291 29 2.91E-01

20 5 5 25 5.06E-03

Granivores 100 13 14 14 1.44E-02

1000 58 65 6 6.46E-02
Avian Body Adjusted LD50

Weight (g) (mg/kg-bw)

20 455.71

100 580.14

1000 819.47



# Dose-based EECs

(mg/kg-bw) Avian Classes and Body Weights (grams)

small mid large

20 100 1000

Short Grass 219.19 124.99 55.96

Tall Grass 100.46 57.29 25.65 Broadleaf plants 123.29 70.31 31.48 Fruits/pods 13.70 7.81 3.50 Arthropods 85.85 48.95 21.92

Seeds 3.04 1.74 0.78



# Dose-based RQs

(Dose-based EEC/adjusted LD50) Avian Acute RQs Size Class (grams)

20 100 1000

Short Grass 0.48 0.22 0.07

Tall Grass 0.22 0.10 0.03 Broadleaf plants 0.27 0.12 0.04 Fruits/pods 0.03 0.01 0.00 Arthropods 0.19 0.08 0.03

Seeds 0.01 0.00 0.00



# Dietary-based RQs

(Dietary-based EEC/LC50 or NOAEC) RQs

Acute Chronic

Short Grass #DIV/0! 2.19

Tall Grass #DIV/0! 1.00 Broadleaf plants #DIV/0! 1.23 Fruits/pods/seeds #DIV/0! 0.14 Arthropods #DIV/0! 0.86

### 110 Mammalian Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI

Class Weight (g bwt/day) (g/day) consumed (kg-diet/day)

15 3 14 95 1.43E-02

Herbivores/ 35 5 23 66 2.31E-02

insectivores 1000 31 153 15 1.53E-01

15 3 3 21 3.18E-03

Grainvores 35 5 5 15 5.13E-03

1000 31 34 3 3.40E-02

Mammalian Body Adjusted Adjusted

Class Weight LD50 NOAEL

15 1294.52 2.86

Herbivores/ 35 1047.41 2.31

insectivores 1000 453.04 1.00

15 1294.52 2.86

Granivores 35 1047.41 2.31

1000 453.04 1.00



# Dose-Based EECs

(mg/kg-bw) Mammalian Classes and Body weight

(grams)

15 35 1000

Short Grass 183.49 126.82 29.40

Tall Grass 84.10 58.12 13.48 Broadleaf plants 103.21 71.33 16.54 Fruits/pods 11.47 7.93 1.84 Arthropods 71.87 49.67 11.52

Seeds 2.55 1.76 0.41



# Dose-based RQs

(Dose-based EEC/LD50 or NOAEL) Small mammal Medium mammal Large mammal

15 grams 35 grams 1000 grams

Acute Chronic Acute Chronic Acute Chronic

Short Grass 0.14 64.22 0.12 54.86 0.06 29.41

Tall Grass 0.06 29.43 0.06 25.14 0.03 13.48
Broadleaf plants 0.08 36.12 0.07 30.86 0.04 16.54
Fruits/pods 0.01 4.01 0.01 3.43 0.00 1.84
Arthropods 0.06 25.15 0.05 21.49 0.03 11.52

Seeds 0.00 0.89 0.00 0.76 0.00 0.41

### 111 

# Dietary-based RQs

(Dietary-based EEC/LC50 or NOAEC) Mammal RQs

Acute Chronic

Short Grass #DIV/0! 7.40

Tall Grass #DIV/0! 3.39 Broadleaf plants #DIV/0! 4.16 Fruits/pods/seeds #DIV/0! 0.46
Arthropods #DIV/0! 2.90

### 112 

# Appendix F. Sample KABAM Files

Table 1. Chemical characteristics of Flufenacet.

Characteristic Value Comments/Guidance

Pesticide Name Flufenacet Required input

Log K OW 3.2 Required input Enter value from acceptable or supplemental study submitted by registrant or availabl e in scientific literature.

K OW 1585 No input necessary. This value is calculated automatically from the Log K OW value entered above.

K OC (L/kg OC) 434 Required input Input value used in PRZM/EXAMS to derive EECs. Follow input parameter guidance for deriving this parameter value (USEPA 2002).

Time to steady state (T S ; days) 3 No input necessary. This value is calculated automatically from the Log K OW value entered above.

Pore water EEC (μg/L) 10.5 Required input Enter value generated by PRZM/EXAMS benthic file. PRZM/EXAMS EEC represents the freely dissolved concentration of the pesticide in the pore water of the sediment. The appropriate averaging period of the EEC is dependent on the specific pesticide being modeled and is

based on the time it takes for the chemical to reach steady state. Select the EEC generated by PRZM/EXAMS which has an averaging period closest to the time to steady state

calculated above. In cases where the time to steady state exceeds 365 days, the user should select the EEC representing the average of yearly averages. The peak EEC

should not be used.

Water Column EEC (μg/L) 9.07 Required input Enter value generated by PRZM/EXAMS water column file. PRZM/EXAMS EEC represents the freely dissolved concentration of the pesticide in the water column. The appropriate averaging period of the EEC is dependent on the specific pesticide being modeled and is based on the time it

takes for the chemical to reac h steady state. The averaging period used for the water column EEC should be the same as the one selected for the pore water EEC (discussed above).

Table 3. Mammalian and avian toxicity data for Flufenacet. These are required inputs.

### 113 Animal Measure of effect (units) Value Species If selected species is

"other," enter body weight (in kg) here.

Avian LD 50 (mg/kgbw) 461 other 21.6

LC 50 (mg/kgdiet) Northern bobwhite quail

NOAEC (mg/kg-diet) 88 mallard duck

Mineau Scaling

Factor 1.15 Default value for all species is 1.15 (for chemical specific

values, see Mineau et al. 1996).

Mammalian LD 50 (mg/kgbw) 589 laboratory rat

LC 50 (mg/kgdiet) N/A other

Chronic Endpoint 1.3 laboratory rat

units of chronic endpoint* mg/kg-bw

Table 11. Estimated concentrations of Flufenacet in ecosystem components.

Ecosystem Component Total

concentration

(μg/kg-ww) Lipid

normalized

concentration

(μg/kg-lipid) Contribution

due to diet (μg/kg-ww) Contribution

due to respiration (μg/kg-ww)
Water (total)* 9 N/A N/A N/A
Water (freely dissolved)* 9 N/A N/A N/A
Sediment (pore water)* 11 N/A N/A N/A
Sediment (in solid)** 182 N/A N/A N/A
Phytoplankton 680 33985 N/A 679.69
Zooplankton 500 16652 0.28 499.28

Benthic Invertebrates 549 18291 0.81 547.92

Filter Feeders 364 18194 0.52 363.35

Small Fish 705 17633 3.02 702.32

Medium Fish 708 17690 5.72 701.88 Large Fish 706 17649 10.21 695.75
* Units: μg/L; **Units: μg/kg-dw

Table 12. Total BCFand BAF values of Flufenacet in aquatic trophic levels.

### 114 Trophic Level Total BCF(μg/kgww)/(μg/L) Total BAF(μg/kgww)/(μg/L)
Phytoplankton 77 75 Zooplankton 55 55

Benthic Invertebrates 60 60

Filter Feeders 40 40

Small Fish 77 78

Medium Fish 77 78 Large Fish 77 78

Table 13. Lipid-normalized BCF, BAF, BMF and BSAF values of Flufenacet in aquatic trophic levels.

Trophic Level BCF(μg/kglipid)/(μg/L) BAF(μg/kglipid)/(μg/L) BMF(μg/kglipid)/(μg/kglipid) BSAF(μg/kglipid)/(μg/kgOC)
Phytoplankton 3849 3747 N/A 7 Zooplankton 1835 1836 0.49 4

Benthic Invertebrates 2014 2017 1.09 4

Filter Feeders 2004 2006 1.09 4

Small Fish 1937 1944 1.01 4

Medium Fish 1937 1950 0.98 4 Large Fish 1922 1946 1.00 4

Table 14. Calculation of EECs for mammals and birds consuming fish contaminated by

Flufenacet.
Wildlife Species Biological Parameters EECs (pesticide intake) Body Weight

(kg) Dry Food IngestionRate (kgdry food/kgbw/day) Wet Food IngestionRate (kgwetfood/kgbw/day) Drinking

Water

Intake (L/d) Dose

Based(mg/kgbw/d) Dietary

Based (ppm)

Mammalian

fog/water shrew 0.02 0.140 0.585 0.003 0.322 0.55

rice rat/starnosed mole 0.1 0.107 0.484 0.011 0.262 0.54

small mink 0.5 0.079 0.293 0.048 0.209 0.71

large mink 1.8 0.062 0.229 0.168 0.163 0.71

small river otter 5.0 0.052 0.191 0.421 0.136 0.71

### 115 large river otter 15.0 0.042 0.157 1.133 0.112 0.71

Avian
sandpipers 0.0 0.228 1.034 0.004 0.5612 0.54

cranes 6.7 0.030 0.136 0.211 0.0739 0.54

rails 0.1 0.147 0.577 0.010 0.3633 0.63

herons 2.9 0.040 0.157 0.120 0.0992 0.63

small osprey 1.3 0.054 0.199 0.069 0.1416 0.71

white pelican 7.5 0.029 0.107 0.228 0.0756 0.71

Table 15. Calculation of toxicity values for mammals and birds consuming fish contaminated by Flufenacet.

Wildlife Species Toxicity Values

Acute Chronic

Dose

Based(mg/kgbw) Dietary

Based (mg/kg-diet) Dose Based (mg/kg-bw) Dietary

Based(mg/kgdiet)

Mammalian fog/water shrew 1236.84 N/A 2.73 26

rice rat/starnosed mole 839.03 N/A 1.85 26

small mink 553.13 N/A 1.22 26

large mink 391.12 N/A 0.86 26

small river otter 302.96 N/A 0.67 26

large river otter 230.20 N/A 0.51 26

Avian
sandpipers 161.69 0.00 N/A 88

cranes 386.76 0.00 N/A 88

rails 195.12 0.00 N/A 88

herons 341.11 0.00 N/A 88

small osprey 300.66 0.00 N/A 88

### 116 white pelican 393.36 0.00 N/A 88

Table 16. Calculation of RQ values for mammals and birds consuming fish contaminated by Flufenacet.

Wildlife Species Acute Chronic

Dose

Based Dietary

Based Dose Based Dietary

Based

Mammalian fog/water shrew 0.000 N/A 0.118 0.021

rice rat/starnosed mole 0.000 N/A 0.142 0.021

small mink 0.000 N/A 0.171 0.027

large mink 0.000 N/A 0.189 0.027

small river otter 0.000 N/A 0.203 0.027

large river otter 0.000 N/A 0.220 0.027

Avian
sandpipers 0.003 #DIV/0! N/A 0.006

cranes 0.000 #DIV/0! N/A 0.006

rails 0.002 #DIV/0! N/A 0.007

herons 0.000 #DIV/0! N/A 0.007

small osprey 0.000 #DIV/0! N/A 0.008

white pelican 0.000 #DIV/0! N/A 0.008

### 117 

# Appendix G. Risk Quotient Method

Risk characterization integrates the results of th e exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The mean s of this integration is called the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by acute and chronic ecotoxicity values.

RQ = EXPOSURE/TOXICITY

RQs are then compared to OPP's levels of concern (LOCs). These LOCs are used by OPP to analyze potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate that a pest icide used as directed has the pot ential to cause adverse effects on nontarget organisms. LOCs currently address the following risk presum ption categories: (1) acute risks - regulatory action may be warranted in addition to re stricted use classification, (2) acute restricted use - the potenti al for acute risk is high, but ma y be mitigated through restricted use classification, (3) acute enda ngered species - endangered species may be adversely affected, and (4) chronic risk - the potential for chronic risk is high regula tory action may be warranted. Currently, EFED does not perform assessments for ch ronic risk to plants, acute or chronic risks to insects, or chronic risk from granul ar/bait formulations to birds or mammals.

The ecotoxicity test values (measurement e ndpoints) used in the acu te and chronic risk quotients are derived from required studies. Examples of ecotoxicity values derived from shortterm laboratory studies that assess acute effects are: (1) LC 50 

### (fish and birds), (2) LD 50 

### (birds and mammals), (3) EC 50 

### (aquatic plants and aquati c invertebrates) and (4) EC 25 

### (terrestrial plants). Examples of toxicity test effect levels derive d from the results of l ong-term laboratory studies that assess chronic effects are: (1) LOAEL or L OAEC (birds, fish, and aqua tic invertebrates) and (2) NOAEL or NOAEC (birds, fish and aquatic inve rtebrates). For birds, mammals, fish and aquatic invertebrates the NOAEL or NOAEC generally is used as the ecotoxi city test value in assessing chronic effects, although other values ma y be used when justified. Risk presumptions and the corresponding RQs and LOCs, are tabulated below.

### 118 Table 1. Risk presumptions for terrestrial animals base d on risk quotients (RQ) and levels of concern (LOC).

Risk Presumption RQ LOC

Birds

Acute Risk EEC 1 /LC 50 or LD 50 /ft 2 or LD 50 /day 3 0.5

Acute Restricted Use EEC/LC 50 or LD 50 /ft 2 or LD 50 /day (or LD 50 < 50 mg/kg) 0.2

Acute Endangered Species EEC/LC 50 or LD 50 /ft 2 or LD 50 /day 0.1

Chronic Risk EEC/NOAEC 1

Wild Mammals

Acute Risk EEC/LC 50 or LD 50 /ft 2 or LD 50 /day 0.5

Acute Restricted Use EEC/LC 50 or LD 50 /ft 2 or LD 50 /day (or LD 50 < 50 mg/kg) 0.2

Acute Endangered Species EEC/LC 50 or LD 50 /ft 2 or LD 50 /day 0.1

Chronic Risk EEC/NOAEC 1

1 abbreviation for Estimated Environmental Co ncentration (ppm) on avian/mammalian food items

2 mg/ft 2

3 mg of toxicant consumed/day

LD 50 * wt. of bird

LD 50 * wt. of bird

Table 2. Risk presumptions for aquatic animals based on risk quotients (RQ) and levels of concern (LOC).

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 = (ppm or ppb) in water

Table 3. Risk presumptions for plants based on risk quotients (RQ) and levels of concern (LOC).

Risk Presumption RQ LOC

Terrestrial and Semi-Aquatic Plants

Acute Risk EEC 1 /EC 25 1

Acute Endangered Species EEC/EC 05 or NOAEC 1

Aquatic Plants

Acute Risk EEC 2 /EC 50 1

Acute Endangered Species EEC/EC 05 or NOAEC 1

1 EEC = lbs ai/A

2 EEC = (ppb/ppm) in water