Page 1 of 27 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

PC Code: 123001 DP Barcode: 427466

Dec ember 0 9 , 2015

MEMORANDUM

Subject: Problem Formulation for the Registration Review Environmental Fate and Ecological Risk of Flumetrali n

To: Katherine St. Clair , Chemical Review Manager Kevin Costello

, Branch Chief Risk Management and Implementation Branch 2 Pesticide Re

- Evaluation Division (7508P)

From: B rian D. Kiernan , Biologist Ibrahim Abdel

- Saheb, Environmental Scientist En vironmental Risk Branch 6 Environmental Fate and Effects Division (7507P)

Through: Mark Corbin, Branch Chief Monica Wait, RAPL Environmental Risk Branch 6 Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Di vision (EFED) has completed the problem formulation (PF) for the upcoming environmental fate and ecological risk for the r egistration r eview of the plant growth regulator flumetralin (PC Code 1 23001 ).

Flumetralin is registered for use as a systemic plant growth reg ulator (PGR) intended to control axillary growth (suckers) in tobacco crops.

T he use pattern for flumetralin has not changed since the Reregistra t ion Eligibility Decision (RED) in 200 7 and there have been minimal new data submitted to EPA since that time ; however, data gaps remain

. This document contains a preliminary risk review based on the currently available data. This will serve as a basis for the preliminary risk assessment which will be conducted when the existing data gaps have been add ressed.Page 2 of 27 Taxa considered po tentially at risk based on the provisional assessment are listed fish from acute exposure, birds and mammals from chronic exposure

, and terrestrial plants. There are no data for aquatic nonvascular plants

, and therefore risk wo uld be presumed.

Data Gaps

The environmental fate dataset for flumetralin is sparse. An acceptable study has been submitted only for hydrolysis, and supplemental studies have been submitted for aerobic and anaerobic soil metabolism, soil mobility, and f ish bioaccumulation.

T he require d studies under 40 CFR Part 158 include:

Environmental Fate

• Aquatic Photolysis (835.2240)

• Soil Photolysis (835.2410)

• Aerobic Aquatic Metabolism (835. 4 3 00 )

• Anaerobic Aquatic Metabolism (835.4400)

• Terrestrial Field Dissipat ion study (835.6100)

• Enforcement Analytical method for Water and corresponding independent laboratory validation (ILV) (850.6100)

• Enforcement Analytical Method for Soil and corresponding ILV (850.6100)

Ecological Effects

• Flumetralin use may be of exposur e concern for pollinators visiting off

- site plants that are contaminated by spray drift . Acceptable toxicity data to honey bee adult s and larvae have not been submitted for flumetralin and these data are needed to fulfill EPA’s recent policy on pollinator protection 1

. A T ier I study on the toxicity of residues on foliage (OCSPP 850.3030) is not needed since results of the honey bee acute contact LD 50 is >100 μg a.i./bee , well above the 11 μg a.i./bee trigger criterion

. The following six Tier I

, II and III honey bee studies

, yet to be submitted for flumetralin

, are required 2 :

o H oneybee adult and larval acute oral toxicity study (following OECD 237 , Tier I )

o H oneybee adult 10

- day chronic oral (special study ; Tier I )

o H oneybee larval repeated dose study (specia l study renamed as honeybee larval chronic oral toxicity study , Tier I )

o Semi

- field testing for pollinators (special study, Tier II).

o F ield testing for pollinators (OCSPP 850.3040 , Tier III )

o F ield trial of residues in pollen and nectar (special study , Tie r II I )

1 (Guidance for Assessing Pesticide Risks to Bees, 06.23.2014; signed by Donald Brady, Director, EFED; http://www2.epa. gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf )

2 The need for higher Tier semi

- field and full field pollinator studies for flumetralin will be determined after review of these Tier I studies.Page 3 of 27 Note that it is possible to conduct the larval chronic oral study in such a way as to derive both an LD 50 (acute endpoint of interest) and a NOAEC (chronic endpoint of interest) from a single study. If the chronic larval toxicity study is conducted in such a way that it derives both an LD 50 and NOAEC, then a separate acute larval toxicity stud ies are not needed. For pollinator studies without finalized guidelines, protocols should be submitted for EPA review and comment prior to study initiation.

• Aquatic nonvascular plants (Guidelines 850.4500, 850.4550). While data on green algae are used provisionally in this review (FOOTPRINT database; http://sitem.herts.ac.uk/aeru/footprint/ ) , the underlying study has not been reviewed by EPA. This study shou ld be submitted for EPA review. Further, three (cyanobacteria, centric diatom, pinnate diatom) other taxa of aquatic nonvascular species are necessary to complete a risk
assessment.

• Avian acute oral toxicity (Guideline 850.2100)

. D ata have not been sub mitted for a passerine species exposed to flumetralin , under the 40 CFR Part 158 data requirements. Alt hough the available bobwhite quail study indicates flumetralin has low toxicity to upland game bird species, it is uncertain whether passerines may be mo re or less sensitive to this chemical as a result of their higher metabolic rate and differing metabolic pathways. Given the reproduction effects of n umber of survivors, hatchlings, viable embryos, and live embryos observed in birds, EFED cannot preclude t he potential risk to passerines which are small

- sized birds.Page 4 of 27 

## Problem Formulation for the Environmental Fate and Ecological Risk in Support of the Registration Review of Flumet ra lin

N

- (2

- chloro

- 6

- fluorobenzyl)

- N

- ethyl

- α,α,α - trifluoro

- 2,6

- dini tr o - p - toluidine 

### CAS Registry Number: 62924

- 70

- 3 PC Code: 12 3001

Prepared by: Brian D. Kiernan , Biologist Ibrahim Abdel

- Saheb

, Environmental Scientist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch VI 1200 Pennsylvania Ave., NW Mail Code 7507P Washington, DC 20460 Reviewed by: Nathan Miller

, Biolog ist William P. Eckel, Ph. D., Senior Science Advisor Monica Wait

, RAPL Mark Corbin, ERB6 Chie f

December , 2015 

### Office of Chemical Safety and Pollution PreventionPage 5 of 27 

### Contents
1. Introduction

................................ ................................ ................................ ............................. 6 2. Conclusions

................................ ................................ ................................ ............................. 6 2.1. E cological Risk Assessments

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

................................ ................................ ............................... 8 3. Environmental Fate and Transport

................................ ................................ ............................. 8 3.1. Transformation Products

................................ ................................ ................................ 11 4. Receptors and Effects

................................ ................................ ................................ ........... 11 4.1. Effects to Aquatic Organisms

................................ ................................ ........................ 12 4.2. Effects to Terrestrial Organisms

................................ ................................ .................... 13 4.3. Ecological Incidents

................................ ................................ ................................ ....... 14 5. Exposure Pathways of Concern

................................ ................................ ............................ 15 6. Analysis Plan

................................ ................................ ................................ ........................... 15 6.1. Stressors of Concern

................................ ................................ ................................ ....... 15 6.2. Measures of Exposure

................................ ................................ ................................ ... 15 6.4 Preliminary R isk Review

................................ ................................ ............................... 17 7. Federally Threatened and Endangered (Listed) Species Concerns

................................ ....... 19 8. Endocrine Disruptor Screening Program (EDSP)

................................ ............................... 20 9. Environmental Fate and Ecological Effects Data

................................ ................................ . 20 9.1. Environmental Fate

................................ ................................ ................................ ............ 20 9.2. Effects

................................ ................................ ................................ ................................ 22Page 6 of 27 

## 1. Introduction

EFED evaluated the most recent ecolog ical risk assessments for flumetralin in association with the updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registration review. With few new data submitted and no new actions since the EFED reregistration eligibility decision ( RED ) chapter issued in 200 7 , EFED proceeded with a preliminary risk review using the latest EPA science policies and risk assessment methodologies based the data currently available for fl umetralin

.

Flumetralin is used as a plant growth regulator on tobacco crops. Flumetralin is a pplied as a post

- emergent plant growth regulator on tobacco crops to control the growth of axillary buds (suckers) after removal of the apical meristem (‘top ping’), thus forcing the plants to expend energy in growing the existing leaves larger, rather than in new growth. The specific mechanism of action is not well documented. It is applied once per growing season by ground or handheld
spray , or in some case s, dropline or jug applications

. Applications are made when “most tobacco plants are in the elongated button to early flower stage,” when topping typically occurs. Timing of topping varies by region, but generally occur s between June and August.

Flumetr alin has been registered since 1983 for this use only, and is undergoing registration review in the United States. There are currently three Section 3 technical products and four active end

- use products registered for flumetralin. The labels allow applic ation at a maximum rate of 1.2 pounds of active ingredient per acre ( lb a

. i

. /A )

. A 2015 Screening Level Usage Analysis performed by BEAD showed that between 2004 and 2012 an average of 35 percent, and up to 55 percent, of tobacco crops were treated with f lumetralin. Between 2009 and 2013, approximately 103,000 pounds of f lumetralin were applied at an average application rate of 0.6 lbs a.i./ A over 170,000 acres annually

. While overall usage has increase d in recent years , the geographic distribution of a pplication has remained fairly consistent. From 2003 to 2007 and 2008 to 2013 over half of f lumetralin was applied in North Carolina, followed distantly by Kentucky and Virginia, with the remaining 15 percent of usage split between six to ten other states

. The average percent crop treated (PCT) for use of flumetralin on tobacco during 2007 was 35% for b urley t obacco a nd 60% for dark tobacco.



## 2. Pre liminary Risk Conclusions

**2.1. Ecological Risk Assessments** 

The Agency previously conducted an ecological risk assessment for flumetralin during reregistration , EFED’s RED chapter issued in 2007 (July 10, 2007; D326441 )

. The major ecological conclusions pre sented in the previous risk assessment were as follows:Page 7 of 27 Table 1. Summary of Risk Concerns Identified for Flumetralin in Previous Assessments

Uses Taxa with Acute LOC Exceedances Taxa with Chronic LOC Exceedances Taxa with No LOC Exceedances B ioconcentration? Persistence Degradates of Concern

Tobacco Terrestrial and aquatic plants Birds and their surrogates 1

, mammals, listed fish Terrestrial invertebrates 2

, aquatic invertebrates No , based on KABAM N o None

1 Chronic risk presumed for birds due to lack of data.

2 B ased on acute contact t oxicity with adult bees; recent data requirements outstanding

.

As a resul t of the preliminary risk review for Registration Review, EFED de termined that flumetralin exposures to aquatic organisms continue to be minimal because the new aquatic EECs (Estimated Environmental Concentrations) are similar to previous calculated EECs. Hence, discussions of risks to aquatic organisms have not been updated in this document, but rather are summarized from the RED. Details of the aquatic risk conclusions can be found in the 200 7 EFED RED chapter

.



### • Fish and Aquatic Invertebrates: There are no acute or chronic risks indicated for nonlisted fish and invertebrates , although the listed species LOC is exceeded for acute risk to freshwater fish

. There are no data examining effects of chronic exposure to estuarine/marine animals; however, the fish endpoint would need to be half that for freshwater fish for there to be an exceedance and the invertebrate endpoint would need to be lower still.

• Aquatic Plants: There are no LOC exceedances for aquatic vascular plants based on Lemna gibba data

. T here are no Agency

- reviewed data for the effect of flumetralin on aquatic nonvascular plants and adverse effects are assumed.

For terrestrial animals, the avian chronic risk conclusions will change from the RED due to submission of new data. Previously r isk to birds from chronic exposure was assumed. While the new data results in an upper

- bound RQ of 1.2 (exceeding the LOC of 1.0), the exceedance is only for birds foraging on short grass. The potential risk to mammals remains similar to that described i n the previous assessment, with RQs up to 8.3. Terrestrial plants, as expected , remain

a concern.

• Birds: There are no acute LOC exceedances for birds ; because the endpoints are non

definitive (greater than the highest dose) RQs are not calculated and ri sk is presumed to be low. Only the upper

- bound chronic RQ for foragers on short grass (1.2) exceeds the LOC. Chronic risks were presumed in the RED due to lack of avian reproduction data. R eproduction data are now available and have been reviewed by EPA (MRIDs 48800302 and 48800301 ).Page 8 of 27 • Terrestrial

- phase Amphibians and Reptiles: Terrestrial

- phase amphibians and reptiles were not assessed previously. EFED currently uses surrogate data (birds) for terrestrial

phase amphibians and reptiles when taxa

- specific d ata are not available. There were no LOC exceedances for birds via the oral and dietary routes; these findings also apply to terrestrial

- phase amphibians and reptiles.



### • Mammals: There are no acute concerns for mammals ; there were no effects seen in the

av ailable acute dose study

. RQs are not calculated but risk is presumed to be low

. However, as described in the previous assessment, there is potential risk to mammals from chronic exposure, with RQs up to 8.3.



### • Terrestrial Invertebrates (Pollinators): Ter restrial invertebrates were previously not assessed quantitatively. Based on the available acute contact study, effects to terrestrial invertebrates are not expected. However, acute dietary risk to adult honeybees cannot be ruled out

. Chronic dietary ri sk to adult honeybees and acute and chronic dietary risk to larval honeybees is uncertain due to a lack of data. While tobacco is very attractive to pollinators when in bloom, topping (which removes the inflorescence ) limits the availability of flowers on the crops.

• Terrestrial Plants: Flumetralin is expected to adversely affect sensitive terrestrial plants, with RQs up to 22 for non

- listed plants and 28 for listed species.



### 2.3. **Clean Water Act Programs**

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

. No a quatic benchmarks have been established for flumetralin and are not availa ble at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm . Any data submitted or otherwise located as part of the registration review process may be used to update aquatic life benchmarks if applicable.



## 3 . Environmental Fate and Transport

Based on K oc values, flumetralin is hardly mobile to immobile (F AO Mobility Clas s es; K oc range of 24,000

- 183,000) and is very persistent in aerobic soil, with a hal f

- life longer than 3 years in one foreign soil. In an anaerobic foreign soil, flumetralin degraded with a half

- li fe of 42 days. Soil metabolism data obtained using U.S. soils are classified as "not acceptabl e

. " Fl u metralin is stable to hydrolysis. All data submitted for photodegradation (in water and on soil ) were n ot acceptable, so it is unknown whether that might be a significant potential route of degradat i on in
t he environment. Although both of the submitted terrestrial field dissipation studies were cl a ssifie d as " unacceptable " for multiple reasons, the available parent concentration data indicate that p ersistence and accumulation of the parent compound may be expected in the field.

The log K ow of 5.45 indicates a high potential to accumulate in such o rganisms ; however, the available BCF data indicates differently ( Table 2 ) . Flumetralin has low volatility and low waterPage 9 of 27 solubility. The only information available on flumetralin degradates was obtained from the anaerobic soil metabolism study conducted on a foreign (U.K.) soil. A major degradate, COA

275536 (chemical name was not provided; structure presented in Appendix I) was detected at a maximum of 33% of the applied (60 days post

- flooding). A minor degradate, CGA

- 27 6 432, was detected at a maximum of 2% of the applied (60 days post

- flooding). In that study, bound

res i dues were a maximum of 18% at 60 days post

- flooding and volatiles were negligible. In anaerobic soil, flumetralin appears to degrade via sequential reduction of the nitro (N O 2 ) group to amin es (NH 2 ) to yield the major degradate CGA

- 275536 (an aniline) and the minor degradate CGA

- 276432, with formation of additional unidentified minor polar/nonpolar products and bound soil residues.

There is a potential for flumetralin to reach surface water through spray drift, as the compound may be applied by ground spray . Because flumetralin is persis t ent in s urface soils, there is also the potential for it to reach surface water through surface runoff eit h er in solution or adsorbed to the soil. Based on t he high adsorption coefficients, it is unlikely that th e re wi l 1 be significant contamination of surface water with flumetralin through subsurface flow. Because most s o ils used to grow tobacco undergo conventional tillage, flumetralin remaining on s urface s oils should eventually be transferred to subsurface soils where it could be expected to degrade or remain adsorbed to soil.

Based on the results of a terrestrial field dissipation study, in whic h leaching was o b served (to 15

- 30 cm), flumetralin appears to have some potential to leach to grou n dwater. However, these results conflict with those from the laboratory mobility studies which indi c ate high levels of adsorption to soil and, therefore, little or no mobility in soil. The potentia l to leach may be
grea ter when there is excessive rainfall or irrigation, particularly if either of these o ccur s close to the ti m e of application, or if the soil conditions allow f or paths of preferential flow. Al so, b e cause ads o rption is highly correlated to organic matter con tent, there may be a greater potenti al for leaching in l ower organic matter soils, such as those used to grow tobacco.

A selection of flumetralin environmental fate and transport properties is summarized in Table 2 below.

Table 2. Physical Chemical and Environmental Fate Properties of Flumetralin

. Parameter Value Source Selected Physical/Chemical Parameters
Chemical Structure

Empirical Formula http://pubchem.ncbi.nlm.nih.Page 10 of 27 Table 2. Physical Chemical and Environmental Fate Properties of Flumetralin

. Parameter Value Source
C 16 H 12 ClF 4 N 3 O 4 gov/compound/flumetralin#s ection=Top

I UAPC Name dinitrophenyl

- U

- 14C]labeled N

- (2

- chloro

- 6

- fluorobenzyl)

- N

- ethyl

- a,a,atrifluoro

- 2,6

- dinitro

- p

toluidine http://pubchem.ncbi.nlm.nih. gov/compound/flumetralin#s

ec tion=Top

CAS Name chloro

- N

- [2,6

- dinitro

- 4

- (trifluoromethyl)phenyl]

- N

- ethyl

- 6

- fluorobenzenemethanamine http://pubchem.ncbi.nlm.nih. gov/compound/flumetralin#s ection=Top

CAS No. 62924

- 70

- 3 http://pubchem.ncbi.nlm.nih. gov/compound/flumetralin#s ection=Top PC Code No. 123001

SMILES string: CCN(CC1=C(C=CC=C1Cl)F)C2=C(C=C(C=C2[ N+](=O)[O

- ]) C(F)(F)F)[N+](=O)[O

- ] http://pubchem.ncbi.nlm.nih. gov/compound/flumetralin#s ection=Top Molecular Weight g/mol 421.7 http://pubchem.ncbi.nlm.nih. gov/compound/flumetralin#s ection=Top Vapor pressure 2.4 x 10

- 7 Torr (0.032 mPa) Pesticide Manual, 10 th Ed., Brit. Crop Protection Council, and The Roy a l Soc. of Chem. 1994 Aqueous solubility ( 20 ° C) 0.07 mg/L Pesticide Manual, 10 th Ed., Brit. Crop Protection Council, and The Roy a l Soc. of Chem. 1994 Henry’s Law Constant 1.9E

- 6 atm

- m 3

- mole

- 1 Calculated from vapor
pressure, Solubility and molecular wt. Log Kow at pH 7 5.45 Pesticide Manual, 10 t h Ed., Brit. Crop Protection Council, and The Roy a l Soc. of Chem. 1994 Persistence Hydrolysis half

- life (pH 5, 7, 9) Stable MRID41761508

Aqueous photolysis half

- life (d) No Data

Aerobic soil metabolism half

- life (d) 1220 MRID 42566201a

Anaerobic soil metabolism half

- life (d) 42 MRID 42566201b

Anaerobic aquatic metabolism half

- life No Data

Aerobic aquatic metabolism half

- life (total system) No Data

Terrestrial Field Dissipation half

- life (days) The rate of dissipation of flumetralin could not be d etermined. Both studies are classified as not acceptable. MRID 43014002; MRID 43014003

.Page 11 of 27 Table 2. Physical Chemical and Environmental Fate Properties of Flumetralin

. Parameter Value Source
Bioaccumulation in Fish 612 MRID 43014003; Acc # 001117114; MRID 48148701 Mobility Adsorption/desorption Organic Carbon Normalized Soil Partition Coefficient (Koc) : 28846, 51100, 182776, 23875 MRID 41761512



### 3.1. Transformation Products

The only information available on flumetralin degradates was obtained from the anaerobic soil metabolism study conducted on a foreign (U.K.) soil. A major degradate, COA

- 275536 (chemical name was not provided; structure presented below) wa s detected at a maximum of 33% of the applied (60 days post

- flooding).



## 4

. Receptors and Effects

In screening

- level ecological risk assessments, the effects characterization describes the t ypes of effects a pesticide can potentially produce in an animal or plant. This characterization is generally based on registrant

- submitted studies that describe acute and chronic effects information for various aquatic and terrestrial animals and plants; however, these data may also be supplemented by data reported in ECOTOX that have met Agency criteria for acceptability.

Toxicity data reported in this section does not include all species potentially affected by fl umetralin use. Only a few species fo r fish, aquatic invertebrates and birds are used to represent all species in flumetralin use areas . For mammals, toxicity studies are limited for the laboratory rat. Also, neither reptiles nor amphibians are tested. The risk assessment assumes that esti mates of risks to avian species are protective of reptilian and terrestrial

- phase amphibian s . The same assumption is used for fish and aquatic

- phase amphibians. Terrestrial plant data are derived from the vegetative vigor and seedling emergence tests, ty pically on 10 agricultural crop species. Typically, one vascular aquatic plant (Lemna gibba) and four aquatic nonvascular plant species are used to represent potential toxicity to all aquatic plant taxa

.

Most of the studies with non

- target organisms were conducted with flumetralin technical. A typical end

- use product (TEP), Prime+ ® , was the test material in the terrestrial plant seedling emergence and vegetative vigor studies. These studies provide the effects basis for riskPage 12 of 27 estimati on. Tables 3 and 4 provide summary of the aquatic and terrestrial t oxicity data used to characterize the potential ecological effects of flumetralin

. Avian reproduction studies have been submitted since the last risk assessment

, and study summaries are provided below

.



### 4.1

**. Effects to Aquatic Organisms** 

Table 3 . Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Flumetralin

Taxonomic

Group Study Type Surrogate Species Toxicity Value (μ g a.i./L) Acute Toxicity Classification

or Adverse Effect Observe d Source (Study classification)

Freshwater fish 1 Acute Bluegill sunfish ( Lepomis macrochirus ) LC 50 = 23 High ly toxic 43456601 (Acceptable)

Chronic Fathead minnow ( Pimephales promelas ) NOAEC = 0.77 Length and weight 00116598 ( Acceptable )

Freshwater i nvertebrates Acute
Water flea ( Daphnia magna ) EC 50 > 160 No more than High ly toxic 43456602 (Acceptable)

Chronic NOAEC >8.8 None 00116600 (Acceptable)

Estuarine/marine fish Acute Sheepshead minnow ( Cyprinodon variegatus ) LC 50 > 250 No more than Highly toxic 43456603 (Acceptable)

Chronic No data

-- --
Estuarine/marine invertebrates Acute Mysid shrimp ( Mysidopsis bahia ) L C 50 = 93 High ly toxic 43456605 (Acceptable) Chronic No data

-- --

Aquatic plants and algae Vascular Duckwe ed ( Lemna gibba ) EC 50 > 160 NOAEC = 16 biomass 43456606 (Acceptable)
Non

vascular No data No data

-- --

1 Freshwater fish may be surrogates for aquatic

- phase amphibians.Page 13 of 27 

### 4.2. **Effects to Terrestrial Organisms**

Table 4. Summary of the Most Sensitive E ndpoints from Terrestrial Toxicity Studies for Flumetralin

Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification or Chronic Effects Observed Source (Study classification)

Birds 1 Acute oral Passerine No data N/A No data

Acute oral Bobwhite quail ( Colinus virginianus ) LD 50 >2150 mg a.i./kg

bw Practically non

toxic 00094016 (Acceptable)

Subacute Dietary LC 50 >4800 mg a.i./kg

diet Practically non

toxic 00094018 (Acceptable)

Chronic 2 Bobwhite quail ( Colinus virgin ianus )

Mallard duck ( An a s platyrhynchos ) NOAEC = 366 mg a.i./kg

- diet LOAEC = 913 mg a.i./kg

- diet

NOAEC = 243 mg a.i./kg

- diet LOAEC = 493 mg a.i./kg

- diet Hatchlings per live embryo

Hatchling weights, 14d survivor weight, adult female weight gain 4880 0302 ( In review )

48800301 ( In review )

Mammals Acute Oral
Laboratory rat LD 50 > 5 000 mg a.i./kg

bw Practically non

toxic 00093998

Chronic NOAEL = 3 00 mg a.i./kg

- diet ~10% decrease in parental weight 00149532

Terrestrial invertebrates Acute Contact

- Adults

Honey bee LD 50 > 100 μg a.i./bee Practically non

toxic 41761507 (Acceptable) Acute Oral

- Adults No data N/A No data

Acute Oral

- Larval No data N/A No da ta

Chronic Oral

– Adults No data N/A No data

Chronic Oral

- Larval No data N/A No data

Terrestrial plants Seedling Emergence Non

- grass (Tomato) IC 25 = 0.039 lb a.i./A NOAEC = 0.019 lb a.i./A biomass 4141847001 (Acceptable) Grass (ryegrass) IC 25 = 0.006 lb a.i./A NOAEC = 0.0048 lb a.i./A height

Vegetative Vigor Non

- grass (Tomato) IC 25 = 0.014 lb a.i./A NOAEC = 0.0048 lb a.i./A height 41847002 (Acceptable) Grass (ryegrass) IC 25 = 0.027 lb a.i./A NOAEC = 0.019 lb a.i./ A biomass

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles. 2 Data received since the 2007 assessment

.Page 14 of 27 Avian reproduction

The only new ecological effects data received since the RED are from chronic exposure reproduction studies for bobwhite quail ( Colinus virginianus ) and mallard duck ( Anas platyrhynchos ). The submission of these studies a ddressed an important data gap identified in the RED.

A one

- generation reproductive toxicity of f lumetralin to 16 pairs per dose level of 22 weeks old northern bobwhite ( Colinus virginianus ; MRID 48800302 in review) was assessed over 21 weeks. Flumetralin was administered to the birds in the diet at mean

- measured concentrations of <LOQ (<20, control), 145, 366, and 913 mg ai/kg diet. No mortalities or signs of toxicity that were related to the treatment were observed in the control or any of the treatment groups during the 21

- week study. No treatment

- related effects were observed for feed consumption or changes in adult or offspring body weight. There was a statistically significant, dose

- dependent reduction in the number of hatchlings per live embryo (Jo nckheere

- Terpstra, p = 0.0484, 7.71% reduction relative to the control) at the highest treatment level. Therefore, the NOAEC is 366 mg ai/kg diet.

A one

- generation reproductive toxicity of f lumetralin to 16 pairs per level of 20 weeks old mallard duck ( A nas platyrhynchos ; MRID 48800301 in review) was assessed over 22 weeks. Flumetralin was administered to the birds in the diet at mean

- measured concentrations were <LOQ (<100, control), 243, 493, and 971 mg ai/kg diet. No mortalities that were related to t he treatment were observed in the control or any of the treatment groups during the 22

- week study. No treatment

- related effects were observed for feed consumption or changes in adult male body weight. Adult female body weight gain was statistically reduce d at the mean

- measured 493 and 971 mg ai/kg diet treatment groups relative to the negative control. Slight dose

- dependent and statistically

- significant reductions were observed in hatchling weight and 14

- day survivor weights at the 493 and 971 mg ai/kg die t treatment groups, relative to the negative control. The resulting NOAEC is 243 mg ai/kg diet.



### 4.3. **Ecological Incidents**

The ecological incident information system (EIIS) is an OPP database that houses ecological incidents that have been reported to the Agency. When available, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, and results of any chemical residue analysis or ot her analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the incident resulted from pesticide exposure. The Avian Monitoring System (AIMS) is a database administered by the American Bird Conserv ancy that contains publicly available data on reported avian incidents involving pesticides. Many of the incidents listed in this database are also in the EIIS.

As of July 2015, t here is one reported incident for flumetralin in the EIIS database . The incident is for plant damage to almonds from direct application. The certainty is given as ‘probable’ andPage 15 of 27 the result of accidental misuse

. Almonds are not a registered use for flumetralin, nor is tobacco a widely grown crop in Tehama, CA, where the damag e occurred.

As of July 2015, t here are no incidents for flumetralin reported in the AIMS database. In addition to the incident reports available in EIIS, there were no aggregate incidents reported to the Agency.



## 5

. Exposure Pathways of Concern

The en vironmental fate and toxicity profile for flumetralin suggests that direct spray, spray drift

, and runoff represent the likely exposure pathways for terrestrial and aquatic non

- target organisms. Animal d rinking water and inhalation exposure pathways were also screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods

. 

## 6 . Analysis Plan

6.1. Stressors of Concern

Parent flumetralin is considered as the sole stressor of concern. The major transform ation product, a reduced analog of the parent, found in the anaerobic soil metabolism study is not expected to affect the aquatic EECs or affect terrestrial organisms.



### 6.2. Measures of Exposure

EFED use d standard ava ilable models to evaluate potential exposures to not previously assessed aquatic and terrestrial organisms and/or exposure routes as described at http://www.epa.gov/pesticides/science/model s_db.htm

. Aquatic Exposure Assessment

EFED updated the aquatic EECs using the current surface water model, Surface Water Concentration Calculator (SWCC), to calculate the aquatic EECs for tobacco

. EECs for the registered use on tobacco are based on 1 st application at 1

. 2 lb a.i./A, applied by ground equipment using the available N orth C arolina tobacco scenario. Results are shown in Table 5 (see model input and output in Appendix I I ). For comparison purposes, PRZM/EXAMS E ECs in Table 5 were copied from EFED’s July 10, 2007 risk assessment to compare the old and new EECs for tobacco

. Aquatic EECs calculated using SWCC and PRZM/EXAMS are very similar, with only minor differences observed.Page 16 of 27 Table 5

. Comparison of Aquatic Estimated Environme ntal Concentratio ns (μg/L) for Flumetralin

. Crop (Model) Peak ( μg/L ) 21

- day Avg ( μg/L ) 60

- day Avg ( μg/L ) Tobacco (SWCC

– N C tobacco scenario ) 3.81 0.442 0.335

Tobacco ( PRZM/EXAMS , 2007 ;

NCtobacco scenario ) 2.27 0.46 0.33

Terrestrial Exposure Assessment

Terrestrial Ver tebrates

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals emphasizing dietary uptak e of pesticide through residues on vegetative and insect forage items. Avian terrestrial EECs are considered representative of potent ial exposure for terrestrial

- phase amphibians and reptiles as well. For exposure to terrestrial organisms, pesticide residues on food items are estimated, based on the assumption that organisms are exposed to a single pesticide residue in a given exposure scenario and obtain 100% of their diet from treated areas . Exposure was evaluated using EECs generated from a spreadsheet

- based screening model (T

- REX v.1. 5

. 2 ) that calculates the food ingestion rates of birds and mammals and the dissipation of a chemica l applied to foliar surfaces for single or multiple applications. The terrestrial food item residue estimates are based on the methods of Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994) and food ingestion rates are estimated using allometr ic equations (USEPA, 1993) . When data on the field dissipation of a chemical are absent, as in this case, EFED assumes a 35

- day foliar dissipation half

- life. However, since only one application is allow ed, the foliar dissipation half

- life is not used in calculations for flumetralin.

The Screening Tool for Inhalation Risk (STIR v1.0 ) was used to calculate an upper

- bound estimate of wildlife inhalation exposure using flumetralin ’s vapor pressure and molecular weight for vapor phase exposure as well as th e maximum application rate and method of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity endpoints (rat LD 50 > 5 000 mg/kg

- bw; rat inhalation LC 50 >2. 2 mg/L) as well as th e most sensitive acute oral avian toxicity endpoint ( bobwhite LD 50 = 2150 mg/kg

- bw). Based on the results of the STIR model, exposure through inhalation of spray drift or the vapor phase of flumetralin is not determined to be a potential pathway of concer n for either avian or mammalian species on an acute exposure basis.

The Screening Imbibition Program (SIP v1.0 ) was used to calculate an upper

- bound estimate of wildlife drinking water exposure using flumetralin ’s solubility ( i.e

., 0.07 mg/L at 20 o C), a nd compared to the most sensitive acute and chronic avian and mammalian toxicity endpoints. R esults of the screen indicate drinking water exposure alone is not a concern for birds or mammals

on either acute or chronic basis.Page 17 of 27 Terrestrial Plants

Exposure to uplan d and wetland plants is estimated using the TerrPlant (v1.2.2) screening model. TerrPlant estimates potential exposure from a single application using default assumptions for runoff and spray drift. No changes are made from the 2007 RED chapter.

6.4 Preliminary Risk Review

No changes to the risk conclusion s found in the 2007 EFED RED chapter have resulted from this review except for the evaluation of risk from chronic exposure to avian species (and their surrogate taxa). In short, there are n o acute or chronic risks identified for aquatic organisms, except for listed fish from acute exposure. Additionally, there remain no data for aquatic nonvascular plants with which to assess potential risk to these taxa , thus risk is presumed.

For terre strial animals, there are no risks identified for birds (and surrogates) and mammals from acute exposure , but data for passerines are outstanding

. The r isk to mammals from chronic exposure identified in the RED chapter remains, but RQs were recalculated w ith the current version of T

- REX. There is a marginal exceedance of the LOC for birds based on chronic
exposure. For both birds and mammals, RQs are for foraging on the treated field. There is uncertainty regarding their likelihood of foraging directly on tobacco plants given the nicotine

. While other on

- field forage is likely to remain, the magnitude of the residues on such forage items may be less than the model indicates.

The dataset is incomplete for flumetralin regarding effects to terrestrial i nvertebrates. There is no indication of risk based on the available acute contact honeybee study; however acute and chronic oral studies are required for both adult and larval honeybees ( http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollina tor_risk_assessment_guidance_06_19_14.pdf ).

As a plant growth regulator , flumetralin is expected to have impacts on terrestrial plants. The risk identified in the RED remains, with grass species seemingly more sensitive to flumetralin exposure than for bs. As reported in the RED (based on the most sensitive species), RQs for nonlisted species range from 0.62 to 22 and for listed species the RQs range from 1.3 to 27.

Flumetralin has a log Kow greater than five, which is often an indicator of potential f or bioaccumulation or biomagnification. However, a run of the KABAM (v1.0) model in 2007

, which explores the likelihood of food

- chain effects based solely on chemical properties, suggests this route of exposure to not be of concern for flumetralin. Also, based on a new review of the existing BCF study (see Table 2 ), the whole

- fish bioconcentration factor is 612X, which is below the factor typically associated with food

- chain effects ( generally > 1000X).Page 18 of 27 Mammals

Dose

- based chronic RQs are as high as an 8

- fold exceedance of the LOC ( Table 6 ), and there are exceedances for both upper

- bound and mean exposure estimates. T here are no exceedances for dietary

- based RQs. When assessing potential chronic risk to mammals, the dietary

- b ased NOAEC is converted to a dose

- based NOAEL which can be scaled to different mammalian size classes. The dose

- based RQs are calculated using a body weight adjusted and consumption

weighted equivalent dose

. The adjustments account for the fact that smaller

- sized animals have
to co nsume more food in terms of their body weight than larger animals and that there is differential sensitivity to chemicals based on body size

. By expressing the Kenaga nomogram

estimated residues in terms of daily equivalent dose, estimated environmental c oncentrations can then be compared to the dose

- based NOAEC. Both sets of RQs are presented in Table 6

.

Table 6

. Upper

- bound Mammalian Chronic Exposure RQs for Flumetralin.

Forage items Dose

- based Dietary

based

Size class 15g 35g 1000g Short grass 8.3 a 7.11 3.8 0.96 Tall grass 3.8 3.3 1.8 0.44 Broadleaf plants 4.69 4.0 2.15 0.54

Fruits/pods 0.52 0.44 0.24 0.06 b

Arthropods 3.3 2.8 1.5 0.38
Seeds 0.12 0.10 0.0 5 xx

a Bold indicates exceeds chronic risk LOC (RQ≥1.0)

. b Dietary

- based RQs include see ds here.

Birds (surrogate for reptiles and terrestrial

- phase amphibians )

As noted previously, avian reproduction data unavailable at the time of the RED have subsequently been submitted. As a result, the previous assumption of risk to these taxa can be quantitatively investigated. Based on the upper

- bound residues calculated in T

- REX, there is a marginal exceedance of the LOC based on the most sensitive of the available data (mallard duck; Table 7 ). There are no exceedances based on the mean exposure v alues.Page 19 of 27 Table 7

. Upper

- bound Avian Chronic Exposure RQs for Flumetralin.

Forage items Dietary

- based

Short grass 1.19 Tall grass 0.54 Broadleaf plants 0.67

Fruits/pods/seeds 0.07

Arthropods 0. 46

a Bold indicates exceeds chronic risk LOC (RQ≥1.0)

.

7

. Federally Threatened and Endangered (Listed) Species Concerns

In November 2013, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectively, the Services) , and the U.S. D epartment of Agricultur e (USDA) released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the

a g encies in response to the N ational A cademy of S ciences’ (NAS) recommendations and r eflect a common approach to risk assessment shared by the a gencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on
sp ecific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA

. The joint Interim Approaches wer e released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 P esticide P rogram D ialogue C ommittee (PPDC) and S tate

- FIFRA Issues Research and Evaluation Group ( SFIREG ) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consid er public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this preliminary risk assessment for flumetralin does not contain a complete ESA analysis that includes ef fects determinations for specific listed species or designated critical habitat. Although EPA has not yet completed effects determinations for specific species or habitats, for this preliminary assessment EPA conducted a brief screening

level assessment fo r all taxa of non

- target wildlife and plants that assumes for the sake of the assessment that listed species and designated critical habitats may be present in the vicinity of the application of flumetralin . This screening level assessment will allow EPA to focus its futurePage 20 of 27 evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. This screening

- level risk assessment for flumetralin indicates potential ris ks of direct effects to listed birds, mammals, and terrestrial plants when used on tobacco . Listed species of birds, mammals, and terrestrial plants may also be affected through indirect effects because of the potential for direct effects on listed and no n

- listed species upon which such species may rely. Potential direct effects on listed birds, mammals, and terrestrial plants from the use of flumetralin may be associated with modification of Primary Constituent Elements (PCEs) of designated critical habi tats, where such designations have been made. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for flumetralin as part of completing this registration review.

8

. Endocrine Disruptor Screening Program (EDSP)

Flumetralin w as not included in the first group of 67 chemicals issued an order to cond uct Tier 1 EDSP testing. For additional information on the EDSP, visit http://www.epa.gov/endo/

.

9

. Environmental Fate and Ecological Effects Data

9 .1. Environmental Fate

Table 8 identifies environmental fate studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.Page 21 of 27 Table 8 . Submitted Environmental Fate Data for Flumetralin

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk

assessment? Justification and Assumptions EPA will Make in Absence of Data 835.2120 Hydrolysis MRID 41761508 Acceptable N o 835.2240 Aqueous photolysis Acc # 246683a M RID 41761509 MRID 41761510 Not acceptable Not acceptable Not acceptable Yes In lieu of available data, conservative assumptions had to be made in order to cond uct the mo deling to determine EECs. The submissi on of new data, if valid, would decrease t h e uncertainty in the aquatic exposure assessment by providing more accurate values for use in determi ning EECs.
835.2410 Soil photolysis MRID 42566201 Acc # 246683b Not acceptable Not acceptable Yes Information f rom this study enables the Agency to determine the stability of the pesticide when exposed to sunlight and to predict the likelihood of the pesticide persisting in the environment, the photoproducts that are likely to be produced, and their stability when exposed to sunlight.
835.4100 Aerobic soil metabolism MRID 42566201a Supplemental No

835.4200 Anaerobic soil metabolism MRID 42566201b Supplemental No

835.4300 Aerobic aquatic metabolism N o D ata submitted Yes In lieu of available data, conservative a ssumptions had to be made in order to cond uct the mo deling to determined EECs. The submission of new data, if valid, would decrease t h e uncertainty in the aquatic exposure assessment by providing more accurate values for use in determi ning EECs.Page 22 of 27 Table 8 . Submitted Environmental Fate Data for Flumetralin

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk

assessment? Justification and Assumptions EPA will Make in Absence of Data 835.4400 Anaerobic aquatic metabolism N o D ata submitted Yes In lieu of available data, conservative assumptions had to be made in order to cond uct the mo deling to determine EECs. The submission of new data, if valid, would decrease t h e uncertainty in the aquatic exposure assessment by providing more accurate values for use in determi ning EECs.
835.1230 835.1240 Adsorption/ desorption and leaching MRID 41761511 MRID 41761512 Supplemental Supplemental No

835.6100 Terrestrial field dissipation MRID 43014002 MRID 43014003 Not acceptable Yes In lieu of available data, conservative assumptions had to be made in order to conduct the modeling to determine EECs. Storage Stability Study (TFD) N o D ata submitted Yes

850.1730 Fish bioconcentration MRID 43014004 Suppl emental No A new study would not provide significantly different results for flumetralin BCF estimates Environmental Chemistry Method: Water 850.6100 Analytical method in water and independent laboratory validation N o D ata submitted Yes Enforcement anal ytical methods are being routinely requested in registration review for use by state lead agencies

. Environmental Chemistry Method: Soil Analytical method in soil and independent laboratory validation N o D ata submitted Yes Enforcement analytical methods are being routinely requested in registration review for use by state lead agencies

.



### 9 **.2. Effects**

The available e cological effects studies are provided below, with MRID s for each guideline requirement as well as study classifications. Rationale for addi tional data requested is presented below.

Flumetralin may cause exposure of pollinators visiting off

- site plants that are contaminated by spray drift. Acceptable toxicity data to honey bee adults and larvae have not been submitted for flumetralin and the se data are needed to fulfill EPA’s recent policy on pollinator protection. A tier I study on the toxicity of residues on foliage (OCSPP 850.3030) is not needed since results of the honey bee acute contact LD 50 is >100 μg a.i./bee, well above the 11 μg a. i./bee triggerPage 23 of 27 criterion . Considering that flumetralin is used when most tobacco plants are in the elongated button to early flower stage, when topping typically occurs, preceding full bloom , exposure of pollinators visiting tobacco plants is likely minim al; however, other pollinator forage in treated areas is likely

. Thus, the following six Tier I, II and III honey bee studies, yet to be submitted for flumetralin , are required:

o Honeybee adult and larval acute oral toxicity study (following OECD 237, Tie r I)

o Honeybee adult 10

- day chronic oral (special study; Tier I)

o Honeybee larval repeated dose study (special study renamed as honeybee larval chronic oral toxicity study, Tier I)

o Semi

- field testing for pollinators (special study, Tier II).

o Field testing for pollinators (OCSPP 850.3040, Tier III)

o Field trial of residues in pollen and nectar (special study, Tier III)
Note that it is possible to conduct the larval chronic oral study in such a way as to derive both an LD 50 (acute endpoint of interest) and a N OAEC (chronic endpoint of interest) from a single study. If the chronic larval toxicity study is conducted in such a way that it derives both an LD 50 and NOAEC, then a separate acute larval toxicity study is not needed. For pollinator studies without fina lized OECD guidelines, protocols should be submitted for EPA review and comment prior to study initiation.

Although requested, th e need for higher Tier semi

- field and full field pollinator studies for flumetralin will be determined after review of these T ier I studies.

Acceptable acute avian acute oral toxicity data were not submitted for a passerine species exposed to flumetralin , which is now required under the 40 CFR Part 158 data requirements. Though the available studies indicate suggest flumetralin has low acute toxicity to bird species, it is uncertain whether passerines may be more or less sensitive to this chemical as a result of their higher metabolic rate and differing metabolic pathways. An avian oral toxicity study is needed for a passerine s pecies.

Additional data needs are for aquatic nonvascular plants. While data on green algae are used provisionally in this assessment, the underlying study has not been reviewed by EPA. Further, three other taxa of aquatic nonvascular species are neces sary to complete a risk assessment (850.4500; 850.4550) . A review of the Footprint database also suggests there are other invertebrate data available; submission of those studies would help develop a more complete understanding of the effects of flumetral in.

Available Ecotoxicity Studies

MRID/Classification Citation Reference

00094016/Acceptable Fletcher, D.W. (1981) Report to Ciba Geigy Corporation, Agricul

- tural Division: Acute Oral Toxicity Study with CGA

- 41065, Tech

- nical in Bobwhite Quail: BL AL No. 81QD3. (Unpublished study received Jan 28, 1982 under 100

- EX

- 72; prepared by Bio

- Life Associates, Ltd., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:246683

- C)Page 24 of 27 00094017/Acceptable Fletcher, D.W. (1981) Report to Ciba Geigy Corporation, Agri cul

- tural Division: Acute Oral Toxicity Study with CGA

- 41065, Tech

- nical in Mallard Ducks: BLAL No. 81DD1. (Unpublished study received Jan 28, 1982 under 100

- EX

- 72; prepared by Bio

- Life Associates, Ltd., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; C DL:246683

- D)

71

- 2 Avian Dietary Toxicity

MRID Citation Reference

00094018/Acceptable Fletcher, D.W. (1981) Report to Ciba Geigy Corporation, Agricul

- tural Division: 8

- day Dietary LC50 Study with CGA

- 41065 Tech

- nical in Bobwhite Quail: BLAL No. 81 QC 5. (Unpublished study received Jan 28, 1982 under 100

- EX

- 72; prepared by Bio

- Life Associates, Ltd. and Ralston Purina Co., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:246683

- E)
00094019/Acceptable Fletcher, D.W. (1981) Report to Ciba G eigy Corporation, Agricul

- tural Division: 8

- day Dietary LC50 Study with CGA

- 41065 Tech

- nical in Mallard Ducklings: BLAL No. 81DC5. (Unpublished study received Jan 28, 1982 under 100

- EX

- 72; prepared by Bio

- Life Associates, Ltd. and Ralston Purina Co., sub mitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:246683

- F)

72

- 1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

116602/Supplemental Griffen, J.; McAllister, W.; Cranor, W.; et al. (1982) Acute Tox

- icity of CGA

- 41065 to Bluegill Su nfish (Lepomis macrochirus): Static Acute Bioassay Report #28783. (Unpublished study re

- ceived Oct 4, 1982 under 100

- 640; prepared by Analytical Bio

Chemistry Laboratories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:248447

- B)
00116603/Sup plemental Griffen, J.; McAllister, W.; Cranor, W.; et al. (1982) Acute Tox

- icity of CGA

- 41065 to Rainbow Trout (Salmo gairdneri): Static Acute Bioassay Report #28784. (Unpublished study received Oct 4, 1982 under 100

- 640; prepared by Analytical Bio

- Chemis try Laboratories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:248447

- C)
43456601/Acceptable Bettencourt, M. (1994) CGA

- 41065: Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) Under Flow

- Through Conditions: Final Report: Lab Project N umber: 94/8/5428: 1781/0394/6438/ 105. Unpublished study prepared by Springborn Labs, Inc. 75 p.

72

- 2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

00116599/Supplemental Forbis, A.; Boudreau, P.; Franklin, L.; et al. (198 2) Acute Tox

- icity of CGA

- 41065 to Daphnia magna: Static Acute Bioassay Re

- port #28785. (Unpublished study received Oct 4, 1982 under 100

- 640; prepared by Analytical Bio

- chemistry Laboratories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:24 8446

- A)Page 25 of 27 43456602/Acceptable Putt, A. (1994) CGA

- 41065: Acute Toxicity to Daphnids (Daphnia magna) Under Flow

Through Conditions: Lab Project Number: 94/9/5487. Unpublished study prepared by Springborn Labs, Inc. 78 p.

72

- 3 Acute Toxicity to Estua rine/Marine Organisms

MRID Citation Reference

43456603/Acceptable Bettencourt, M. (1994) CGA

- 41065: Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow

- Through Conditions: Final Report: Lab Project Number: 94/9/5479: 1781/0394/6435 / 505. Unpublished study prepared by Springborn Labs, Inc. 74
p. 43456604/Acceptable Dionne, E. (1994) CGA

- 41065: Acute Toxicity to Eastern Oyster (Crassostrea virginica) under Flow

- Through Conditions: Final Report: Lab Project Number: 94/7/5391: 1781/03 94/6436/504. Unpublished study prepared by Springborn Labs, Inc. 81 p.
43456605/Acceptable Bettencourt, M. (1994) CGA

- 41065: Acute Toxicity to Mysids (Mysidopsis bahia) Under Flow

- Through Conditions: Final Report: Lab Project Number: 94/10/5493: 1781/039 4/6434/515. Unpublished study prepared by Springborn Labs, Inc. 79 p.

72

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

MRID Citation Reference

00116598/Acceptable Forbis, A.; Franklin, L.; Boudreau, P.; et al. (1982) Early Lif e Stage Toxicity of CGA

41065 to Fathead Minnows (Pimephales promelas, Rafinesque) in a Flow

- through System: Report #29218. Final rept. (Unpublished study received Oct 4, 1982 under 100

- 640; prepared by Analytical Bio

- Chemistry Laboratories, Inc., submitt ed by Ciba

- Geigy Corp., Greensboro, NC; CDL:248445

- B)
00116600/Acceptable Forbis, A.; Franklin, L.; Boudreau, P.; et al. (1982) Chronic Toxicity of CGA

- 41065 to Daphnia Magna in a Flow

- through System: Report #28969. Final rept. Unpublished study received Oct 4, 1982 under 100

- 640; prepared by Analytical Bio

- Chemistry Laboratories, Inc., submitted by Ciba

- Geigy Corp.

122

- 2 Aquatic plant growth

MRID Citation Reference

43456606/Acceptable Hoberg, J. (1994) CGA

- 41065: Toxicity to Duckweed (Lemna gibba): Final Report: Lab Project Number: 94/8/5425: 1781/0394/ 6437/410. Unpublished study prepared by Springborn Labs, Inc. 72 p.

123

- 1 Seed germination/seedling emergence and vegetative vigor

MRID Citation ReferencePage 26 of 27 41847001/Acceptable Ch etram, R. (1991) Tier 2 Seedling Emergence Nontarget Phytotoxi

- city Study Using Prime + (CGA

- 41065): Lab Project Nos. LR90

- 431; TX

- 90

- 0158. Unpublished study prepared by Pan

- Agricultural Laboratories, Inc. 126 p.
41847002/Acceptable Chetram, R. (1991) T ier 2 Vegetative Vigor Nontarget Phytotoxi

- city Study Using Prime + (CGA

- 41065): Lab Project Nos. LR90

- 429; TX

- 90

- 0158. Unpublished study prepared by Pan

- Agricultural Laboratories, Inc. 150 p.

123

- 2 Aquatic plant growth

MRID Citation Reference

43456606/Acceptable Hoberg, J. (1994) CGA

- 41065: Toxicity to Duckweed (Lemna gibba): Final Report: Lab Project Number: 94/8/5425: 1781/0394/ 6437/410. Unpublished study prepared by Springborn Labs, Inc. 72 p.

141

- 1 Honey bee acute contact

MRID C itation Reference

41761507/Acceptable Kirkland, R. (1991) CGA

- 41065 Technical: Acute Contact Toxicity of CGA

- 41065 to Honey Bees (Apis Mellifera L.): Lab Project Number: CAR 198

- 90. Unpublished study prepared by California Agricultu

- ral Research, In c. 32 p.Page 27 of 27 

## Appendix I. SWCC Model output

Table 1. Estimated Environmental Concentrations (ppb) for Flumetralin.

Peak (1

- in

- 10 yr) 3.81

4

- day Avg (1

- in

- 10 yr) 0.965

21

- day Avg (1

- in

- 10 yr) 0.442

60

- day Avg (1

- in

- 10 yr) 0.335

365

- day Avg (1

- in

- 10 y r) 0.267

Entire Simulation Mean 0.228

Table 2. Summary of Model Inputs for Flumetralin.

Scenario NCtobaccoSTD Cropped Area Fraction 1 Koc (ml/g) 71649

Water Half

- Life (days) @ 25 °C 7320

Benthic Half

- Life (days) @ 25 °C 252 Photolysis Half

- Life (da ys) @ 40 °Lat 0

Hydrolysis Half

- Life (days) 0

Soil Half

- Life (days) @ 22 °C 3660

Foliar Half

- Life (days) 35

Molecular Wt 421.7 Vapor Pressure (torr) 2.4E

- 7 Solubility (mg/l) 0.7

Table 3. Application Schedule for Flumetralin.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
6/27 Ground 1.34 0.99 0.062