### 1 

# Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the Registration Review of Fluopicolide

CAS Registry Number: 239110

- 15

- 7

PC Code: 027412

Prepared by: Michael Lowit, Ph.D., Ecologist Anita Ullagaddi, Biologist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division 1200 Pennsylvania Ave nue , NW

Mail Code 7507P Washington, DC 20460 Reviewed by: He Zhong, Ph.D

. , Biologist Meghan Radtke, Ph.D., Biologist

March 14 , 2013 N Cl

C H 2 

### F

F F

N H

O Cl Cl

### 2 Table of Contents

1. Purpose

................................ ................................ ................................ ................................ ....... 3

2. Problem Formulation

................................ ................................ ................................ ................. 3

2.1. Natu re of Regulatory Action

................................ ................................ ............................... 3

2.2. Previous Assessments

................................ ................................ ................................ ......... 3

3. Stressor Source and Distribution

................................ ................................ ............................... 3

3.1. Mode of Action

................................ ................................ ................................ ................... 3 3.2. Overview of Pesticide Use and Usage

................................ ................................ ................ 4 3.3. Environmental Fate and Transport

................................ ................................ ...................... 8

3.4. Clean Water Act

................................ ................................ ................................ ................ 12 4. Recept ors

................................ ................................ ................................ ................................ .. 12 4.1. Effects to Aquatic Organisms

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

................................ ................................ ....................... 14

4.3. Incident Databases Review

................................ ................................ ............................... 16 5. Conceptual Model

................................ ................................ ................................ .................... 16 5.1. Risk Hypothesis

................................ ................................ ................................ ................. 17 5.2. Conceptual Diagram

................................ ................................ ................................ ......... 17 6. Analysis Plan

................................ ................................ ................................ ........................... 20

6.1. Stressor s of Concern

................................ ................................ ................................ ......... 20 6.2. Measures of Exposure

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

6.3. Measures of Effect

................................ ................................ ................................ ............ 22 6.4. Integration of Exposure and Effects

................................ ................................ ................. 22

6.5. Deterministic and Probabilistic Assessment Methods

................................ ...................... 22 6.6. Endangered Species Assessment

................................ ................................ ...................... 23 6.7. Endocrine Disruptor Screening Program

................................ ................................ .......... 23 6.8. Drinking Water Assessment

................................ ................................ ............................. 23 7. Preliminary Identification of Data Gaps

................................ ................................ .................. 23 7.1. Fate Data Gaps

................................ ................................ ................................ .................. 24 7.2. Effects Data Gaps

................................ ................................ ................................ ............. 25

8. References

................................ ................................ ................................ ................................ 28 Appendix A. SIP Re sults for Degradate BAM

................................ ................................ ............. 29

### 3 1. Purpose

The purpose of this problem formulation is to provide an understanding of what is known about the environmental fate, ecological effects, and currently registered uses of fluopicolide. This document provides a plan for analyzing data relevant to fluopicolide and for conducting environmental fate, ecological risk, endangered species, and drinking water exposure

assessment s for its registered uses. Additionally, this problem formulation identifies data gaps, uncertainties, and potential assumptions used to address those uncertainties relative to characterizing the potential ecological risk associated with the registered us es of fluopicolide.

2. Problem Formulation

2.1. Nature of Regulatory Action

As part of the implementation of the new Registration Review program 1 

### pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the United Sta tes Environmental Protection Agency (the Agency or EPA) is beginning its evaluation of fluopicolide to determine whether it continues to meet the FIFRA standard for registration. This problem formulation in support of the Registration Review of fluopicolid e will be posted in the initial docket, which will open the public phase of the review process.

2.2. Previous Assessments

Fluopicolide was first registered in the US in 2007. EFED has conducted two ecological risk assessments and five drinking water asse ssments (DWA)

. The previous risk assessments

identified risk concern for birds ( acute and chronic for ornamentals ; chronic for ornamentals ), mammals ( chronic; all uses), listed fish ( acute; ornamentals ) , and listed terrestrial plants (all

uses )

. Ad ditionally, risk concern was identified for mammals ( chronic; turf and ornamentals ) from exposure to the major degradate, 2,6

- dichlorobenzamide (BAM)

.

3. Stressor Source and Distribution

Fluopicolide is a fungicide reg istered for agricultural and non

- ag ricultural use

. The formulat ed product, a suspension concentrate

, may be applied by ground or aerial equipment, depending on the crop. Application methods include broadcast, chemigation, spray, soil drench treatment, band treatment, and container

- plant treatment. BAM will be considered in the risk assessment as appropriate.

3.1. Mode of Action

Fluopicolide belongs to the Fungicide Resistance Action Committee (FRAC) group B5. It is a systemic fungicide that controls oomycete pathogens shown to delocalize spectrin

- like proteins. Fluopicolide is labeled for use against a wide range of oomycete (Phycomycete) diseases

1 http://www.epa.gov/oppsrrd1/registration_review/

### 4 including downy mildews ( Plasmopara, Pseudoperonospara, Peronospora, Bremia ), late blight ( Phytophthora ), and some Pythium species.

3.2. Overview of Pesticide Use and Usage

Uses and application rates are based on the most recent label use information system report (LUIS report), provided by the Biological and Economic Analysis Division (BEAD) ( 10/31/2012 )

. The maximum appl ication rates and application methods are listed in Table 1

. The Registration Review risk assessment will be based on current label information at the time of the assessment, as provided by BEAD

.

To reduce uncertainty in the risk assessment, the Agency requests that the registrant provide additional label information where necessary on the number of applications per year, the total amount applied per year rather than on a per season basis , and the application interval

.

Table 1. Maximum Application Rate s for Registered Uses of Fluopicolide

Use Site Application Method Maximum Single Application

Rate (lb ai / A ) Maximum

Number of Applications

per Crop

Cycle Maximum

Seasonal Application

Rate (lb ai / A ) Minimum Application

Interval

(days)

Agricultural Uses

Brassica (head and stem) vegetables A 0.12 5 4 NS (0.5) 7

G (Chemigation, soil drench treatment, spray) 0.125

4 NS (0.5) 7

Bulb vegetables A 0.125 4 NS (0.5) 7

G (Chemigation, spray) 0.125 4 NS (0.5) 7

Carrot (including tops) A 0.125 3 0.374 14

G (Band treatment, broadcast, chemigation, spray) 0.125

3 0.374 14

Cucurbit vegetables A 0.125 4 NS (0.5) 7

G (Chemigation, soil drench treatment, spray) 0.125

4 NS (0.5) 7

Fruiting vegetables A 0.125 4 NS (0.5) 7

G (Chemigation, spray) 0.125 4 NS (0.5) 7

Fruits (unspecified) G (Soil drench treatment) 27.133 2 NS (54.266) NS (7)

Grapes A 0.125 4 NS (0.5) 7

G (Chemigation, spray) 0.125 4 NS (0.5) 7

### 5 Use Site Application Method Maximum Single Application

Rate (lb ai / A ) Maximum

Number of Applications

per Crop

Cycle Maximum

Seasonal Application

Rate (lb ai / A ) Minimum Application

Interval

(days)

Leafy vegetables A 0.125 4 NS (0.5) 7

G (Spray) 0.125 4 NS (0.5) 7

Lettuce A 0.114 NS NS 10

G (Chemigation, spray) 0.114 NS NS 10

Potato (white/Irish) A 0.125 4 NS (0.5) 7

G (Band treatment, seed piece treatment, spray) 0.125

4 NS (0.5) 7

Root and tuber vegetables A 0.125 4 NS (0.5) 7

G (Spray) 0.125 4 NS (0.5) 7

Tree nuts G (Soil drench treatment) 27.133 2 NS (54.266) NS (7)

Non

- agricultural Uses

Christmas tree plantations

, ornamental and/or shade trees, ornamental ground cover, ornamental herbaceous plants,

ornamental non

flowering plants, ornamental woody

shrubs and vines G (Soil drench treatment) 27.133 2 NS (54.266) NS (7)

Golf course turf,

c ommercial/

i ndustrial lawns

, ornamental sod farm (turf), recreation area lawns,

residential lawns G (Chemigation, spray) 0.271 NS (2) 1 0.542 1 14

Ornamental lawns

and turf G (Broadcast, chemigation) 0.268 NS (2) 1 0.536 1 NS (7 days)

NA = Not applicable. NS = Not specified; n umbers in parentheses are assumed. G = ground; A = aerial

1 maximum annual number of applications per year and maximum annual application rate

Some labels state that, for certain uses, a fungicide with a different mode of action should be used following the second application of fluopicolide. If labels do not state that the application interval should then increase by the appropriate length of ti me, it will be assumed that the interval stays the same.

### 6 Fluopicolide u sage data was obtained from BEAD’s Chemical Profile ( 11/1/2012 ) and Screening Level Usage Analysis ( 4/13/2012 ). Estimates of fluopicolide usage are presented in Figures 1

and 2 and Table 2 . The usage of fluopicolide increased from 2008 to 2011 with the greatest

average usage on cucumbers, lettuce, and squash in terms of both lb ai applied and area treated. On average, the states with the most agricultural usage in terms of lb ai app lied are Georgia, Michigan, and California

. Another measure of usage is use intensity (expressed as lb ai applied per 1000 acres of farm land). This differs from the application rate, which is expressed as lb ai applied per treated acre. Figure 3 spatial ly represents the use intensity of fluopicolide in the United States, which was greatest in Florida, the Mid

- Atlantic, and New England.

Figure 1. Agricultural Usage Data for Fluopicolide (2008

- 201 1 )

Figure 2. Agricultural Usage Data for Fluopicolide Top Crops (2008

- 201 1 )

### 7 Table 2. Screening Level Estimates of Agricultural Uses of Fluopicolide (Annual Average)

Crop lb ai Percent Crop Treated
Average % Maximum %

Cucumbers 3,000 10 20

Lettuce 1,000 <2.5 10

Onions <500 <2.5 < 2.5

Peppers <500 5 10

Pumpkins <500 <2.5 5

Spinach <500 10 10

Squash 1,000 5 10

Watermelons <500 <2.5 <2.5



### Figure 3. Fluopicolide Usage by Crop Reporting District (2006

- 2010)
This is a map of agricultural pesticide usage at the Crop Reporting District (CRD) level. CRDs are boundaries created by USDA NASS which are aggregates of counties (USDA, 2010). Pesticide usage is displayed as average pounds (for the years 2006

- 2010) per 1,000 acres of farmland in a CRD to normalize for the variation in farmland between CRDs. Farmland acreage was obtained from USDA (2007). [see original Chemical Profile for full references]

### 8 3.3. Environmental Fate and Transport

Vapor pressure (3.03 x 10 - 7 

### Pa at 20 o 

### C) and Henry's Law Constant (3

. 84 x 10 - 5 

### Pa m 3 

### mol - 1 

### ) indicate a low possibility of vola tilization of fluopicolide from soil and water. Laboratory data indicate that fluopicolide is stable to hydrolysis, photolysis (soil and water), aerobic soil metabolism, and anaerobic aquatic metabolism. Based on available laboratory and field studies, one major (2,6

- dichlorobenzamide (BAM) 2 

### ; >10% appl ied) and t hree minor (PCA, AE

06080000 3



### , and AE C648995; <10% applied) degradates of fluopicolide were identified. 4 

### The adsorption coefficient for fluopicolide (mean Koc = 340) suggests that leaching c ould be a route of dissipation. T he available terrestri al field dissipation study showed fluopicolide was typically

detected at a depth range of 0

- 15 cm (all four test sites ) and less frequently at greater depths (e.g., a depth of 45

- 75 cm at one test site on only a single da y). Consistent with laboratory data

, t he terrestrial field dissipation study also indicates that fluopicolide is persistent (118

- 347 day

half

- lives) in terrestrial environments. Fluopicolide has a low potential to bioaccumulate based on the Log Pow (3.26), the rapid depuration (0.49 day hal f

- life), and BCF (44x edible tissue,

186 x non

- edible tissue, and 111x whole fish). A detailed assessment of the environmental fate studies can be found in the new chemical risk assessment (DP 325803+).

The major degradate, BAM, is stable to hydrolysis, aq ueous photolysi s, and aerobic soil

metabolism. Vapor pressure ( 4 .3 x 10 - 4 

### Pa ) and Henry's Law Constant (1.2 x 10 - 4 

### Pa m 3 

### mol - 1 

### ) indicate a low possibility of vola tilization from soil and water. The adsorption coefficient for BAM (mean Koc = 35) suggests that leaching could be a route of dissipation. BAM was typically detected at a depth range of 0

- 15 cm in the available terrestrial field dissipation study and less frequently at greater depths (45

- 60 cm).

The p hysical, chemical, and environmental fate properties of fluopicolide and BAM are summarized in Table 3 and Table 5 , respectively

. Table 4 summarizes the maximum formation of fluopicolide degradation products

.

Table 3

. Physical, Chemical, and Environmental Fate Properties of Fluopicolide

Parameter Value Reference Comments

Chemical Fluopicolide

Chemical Name 2,6

- dichloro

- N

- {[3

- chloro

- 5

- (trifluoromethyl)

- 2

- pyridyl]methyl}benzamide MRID 46474001

MRID 46474002

Empirical Formula C 14 H 8 Cl 3 F 3 N 2 O

CAS Number 239110

- 15

- 7

Structure

2 BAM is also a degradation product of dichlobenil (PC code 027401).

3 Tentative identification

4 A few minor degradates were unidentified. N Cl

C H 2 F

F F

N H

O Cl

Cl

### 9 Parameter Value Reference Comments

SMILES Clc2cccc(Cl)c2C(=O)NCc1ncc(cc 1Cl)C(F)(F)F

Selected Physical/Chemical Parameters

Molecular mass 383.59 MRID 46474001

MRID 46474002

Water Solubility (20°C) 3.02 mg/L MRID 46474020

Log Pow (22°C) 3.26 MRID 46474018

Vapor pressure (20°C) 3.03x10 - 7 Pa MRID 46474023

Henry’s law constant (20°C) 3.84 x10 - 5 Pa·m 3 /mol Calculated

Persistence

Hydrolysis (pH 5, 7, and 9) Stable 1 MRID 46708420 Acceptable

<1% decline at 30 days

Aqueous Photolysis (t 1⁄2 ) Stable 1 MRID 46708422 Acceptable

t 1/2 = 170 days

Soil Photolysis (t 1⁄2 ) Stable 1 MRID 46708424

MRID 46708425 Acceptable

t 1/2 = 80 days

Supplemental

t 1/2 = 182 days

Aerobic Soil Metabolism (t 1⁄2 ) Stable 1 MRID 46708427

MRID 46708428 Supplemental

DT 50 >120 days

Acceptable

t 1/2 = 391, 458 days

Anaerobic Aquatic Metabolism (t 1⁄2 ) Stable 1 MRID 46708429 Acceptable

System DT 50 >365 days

Moved from water to

sediment
Bioaccumulation in Bluegill Sunfish (Depuration t 1⁄2)

(BCF) 0.49 days

44x in edible tissue, 186x in

non

- edible tissue, and 111x in whole fish) MRID 46708446 Acceptable

Average of high and

low treatment

concentrations

Mobility

Koc 283

- 373 mL/g MRID 47040401 Acceptable

Field Dissipation

Terrestrial Field Dissipation (t 1⁄2 ) 118

- 347 days MRID 46708430 Acceptable

1 Stable indicates half

- life extrapolated well beyond the study duration.

### 10 Table 4. Fluopicolide Degradates Identified in Environmental Fate Studies

Degradate

Name IUPAC Name Major Degradates (>10% formed) Minor Degradates (<10% formed)

Maximum Percent Formed

AE C653711 (BAM) 2,6

- dichlorobenzamide Aerobic Soil Metabolism : 40.2% (Day 369, still forming)

MRID 46708428 Hydrolysis : 4% at pH 7 (Day 30

– study termination)

Aqueous photolysis : 4.5% (Day

31

– study termination)

MRID 46708422

Soil Photolysis : 8.58% (Day 15

– study termination)

MRID 46708424

Aerobic Soil Metabolism : 14.4% (Day 56)

MRID 46708427

Anaerobic Aquatic Metabolism : 2.7%, total system (Day 181)

MRID 46708429

Terrestrial field dissipation : 6.6% (Day 28, 60, 121, and 150 in WA soil)

MRID 46708430

AE C657188 (PCA) 3

- Chloro

- 5

- trifluoromethylpyridin

e

- 2

- carboxylic acid -- Aerobic Soil Metabolism : 4.7% (Day 94)

MRID 46708428 7.3% (Day 42)

MRID 46708427

Soil Photolysis : 2.6% (Day 15

– study termination)

MRID 46708425

Anaerobic Aquatic Metabolism : 1.5%, total system (Day 19 and 62)

MRID 46708429

Terrestrial field dissipation : 4.7% (Day 7 in CA soil)

MRID 46708430

Metabolite A 2,6

- Dichloro

- N

- [(3

- chloro

- 5

- trifluoromethyl

- 2

- pyridinyl) hydroxymethyl]

benzamide 1 -- Aerobic Soil Metabolism : 7.8% (Day 116)

MRID 46708428

AE C648995 [3

- Chloro

- 5

- (trifluoromethyl)

- 2

- pyridyl] methylammonium -- Soil Photolysis : 0.29% (Day 15

– study termination)

MRID 46708425

### 11 Degradate

Name IUPAC Name Major Degradates (>10% formed) Minor Degradates (<10% formed)

Maximum Percent Formed

chloride

Unidentified

-- -- Aqueous photolysis: each <

3.5%

MRID 46708422

Soil Photolysis: 0.22% (Day 15

– study termination)

MRID 46708425

Aerobic Soil Metabolism: highest 5.5% (Day 273)

MRID 46708428 highest 3% (Day 98)

MRID 46708427

Anaerobic Aquatic Metabolism:

each less than 2%

MRID 46708429

1 Tentative identification.



### Table 5. Physical, Chemical, and Environmental Fate Properties of BAM

Parameter Value Reference Comments

Chemical BAM

Chemical Name 2,6

- Dichlorobenzamide HSDB 1

Empirical Formula C 7 H 5 Cl 2 NO

CAS Number 2008

- 58

- 4

Structure

SMILES Clc2cccc(Cl)c2C(=O)N

Selected Physical/Chemical Parameters

Molecular mass 190.03 HSDB 1

Water Solubility (23°C) 2700 mg/L

Vapor pressure (25°C) 4 .3 x10 - 4 Pa

Henry’s law constant 1.2 x10 - 4 Pa ·m 3 /mol

Persistence

Hydrolysis (pH 5, 7, and 9) Stable 2 MRID 46708419 Supplemental

<3% decline at 30 days (pH 7)

Aqueous Photolysis (t 1⁄2 ) Stable 2 MRID 45280303 Acceptable

No degradation at 31 days

Aerobic Soil Metabolism (t 1⁄2 ) Stable 2 MRID 45575901 Acceptable

t 1/2 = 1430 and 1780 days O Cl Cl

N 2 H

### 12 Parameter Value Reference Comments

Mobility

Koc 21

- 51 mL/g MRID 45539402 Acceptable

1 http://toxnet.nlm.nih.gov/cgi

- bin/sis/htmlgen?HSDB (accessed 11/7/12)

2 Stable indicates half

- life extrapolated well beyond the study duration.



### 3.4

. Clean Water Act

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

. 5 

### In addition, a Total Maximum Daily Load (TMDL) h as not been developed

. 6 

### The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 7 

### , in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

4. Receptors

Consistent with the process described in the Overview Document (U S EPA, 2004), the risk

assessment for fluopicolide will rely on a surrogate species approach. Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature will

be used t o evaluate the potential direct and indirect effects of fluopicolide to aquatic and terrestrial receptors. This includes toxicity on the technical grade active ingredient, degradates, and when available, formulated products ( e.g. , “Six

- Pack” studies). The open literature studies are identified through EPA’s ECOTOXicology (ECOTOX) database 8 

### , which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and

wildlife.

4.1. Effects to Aquatic Organisms

A summary of the aquatic toxicity data for fluopicolide and degradation products from registrant

- submitted studies is provided in Table 6

. F luopicolide is moderately to highly acutely

toxic to freshwater and estuarine/marine fish and moderately acutely to xic to freshwater and

estuarine/marine invertebrates. Chronic effects to freshwater fish included effec ts on larval length at 294 μg/L. C hronic effects to freshwater invertebrates included a reduction in the number of neonates per surviving adult at 370 μg/L. No chronic studies for estuarine/marine fish

or invertebrates were submitted. The marine diatom was the most sensitive non

- vascular aquatic plant; however, a definitive NOAEC could not be established due to effects occurring at the

lowest concentrat ion tested. No effects were observed in the vascular plant study. For taxa with available data, the major degradate BAM was less toxic than fluopicolide to aquatic organis ms.

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name =PESTICIDES

7 http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1

- sop.pdf

8 http://www.epa.gov/ecotox

### 13 For 3

- chloro

- 5

- trifluoromethylpyridine

- 2

- carboxylic acid (a minor degradate) , the re was one acute freshwater fish study available; this degradate is less toxic than fluopicolide

. Table 6. Summary of Toxicity of Fluopicolide and Degradation Products to Aquatic Organisms
Study Type Species Toxicity Value & Category MRID & Status Fluopicolide

Acute

– Freshwater

Fish

850.1075 Rainbow trout (Oncorhynchus mykiss ) 96

- hr LC 50 : 349 μ g/L * NOAEC: 152 μg/L Highly toxic 467084

- 38 Acceptable

Acute

– Freshwater

Fish

850.1075 Bluegill sunfish ( Lepomis macrochirus ) 96

- hr LC 50 : 720 μg/L

NOAEC: 540 μg/L Highly toxic 467084

- 37 Acceptable

Acute

– Freshwater

Fish

850.1075 Common carp ( Cyprinus carpio ) 96

- hr LC 50 : 1300 μg/L NOAEC: 250 μg/L

Moderately toxic 467084

- 39 Acceptable

Acute

– Freshwater

Fish

850.1075 Ricefish ( Oryzia s latipes ) 96

- hr LC 50 : 670 μg/L NOAEC = 420 μg/L Highly toxic 467084

- 40 Acceptable

Acute

– Freshwater

Fish

850.1075 Zebra fish ( Brachydanio rerio ) 96

- hr LC 50 : 1700 μg/L NOAEC: 960 μg/L

Moderately toxic 467084

- 41 Acceptable

Chronic

– Freshwater

Fish

850.1 400 Fathead minnow ( Pimephales promelas ) NOAEC = 151 μg/L * LOAEC = 294 μg/L (based on larval length) 467084

- 45 Acceptable

Acute

– Estuarine/Marine

Fish

850.1075 Sheepshead minnow (Cyprinodon variegatus ) 96

- hr LC 50 : 410 μg/L * NOAEC: 200 μg/L Highly toxic 467084

- 42 Acceptable

Acute

– Freshwater

Invertebrate

850.1010 Water flea ( Daphnia magna ) 48

- hr EC 50 : >1700 μg/L * NOAEC: 1700 μg/L

Moderately toxic 467084

- 33 Acceptable

Chronic

– Freshwater

Invertebrate

850.1300 Water flea ( Daphnia magna ) NOAEC: 190 μg/L * LOAEC: 370 μg/L (based on number of neonates per surviving adult) 467084

- 44 Acceptable

Acute

– Estuarine/Marine

Invertebrate

850.1025 Eastern oyster ( Crassostrea virginica ) 96

- hr EC 50 : >2600 μg/L * NOAEC: 2600 μg/L

Moderately toxic 467084

- 34 Acceptable

Acute

– Estuarine/Marine

Invertebrate

850.1035 Mysid shrimp ( Americamysis bahia ) 96

- hr LC 50 : 3200 μg/L * NOAEC: 1600 μg/L

Moderately toxic 457084

- 35 Acceptable

Aquatic

– Non

vascular Plants

850.4500 &

850.4550 Green algae ( Pseudokirchneriella subcapitata ) Tier I TGAI

96

- hour EC 50 : >1800 μg/L

96

- hour EC 05 : < 1800 μg/L

NOAEC: <1800 μg/L (based on cell density) 467086

- 49 Supplemental

Green algae ( Pseudokirchneriella subcapitata ) Tier II TGAI

96

- hour EC 50 : 2600 μg/L NOAEC: 590 μg/L (based on cell density) 467086

- 09 Acceptable

### 14 Study Type Species Toxicity Value & Category MRID & Status

Blue

- green algae ( Anabaena flos

- aquae ) Tier I TGAI

96

- hour EC 50 : >2200 μg/L

NOAEC: 2200 μg/L (no effects) 467086

- 08 Acceptable

Marine diatom ( Skeletonema costatum ) Tier II TGAI

96

- hour EC 50 : 51 μg/L *

96

- hour EC 05 : <1.4 μg/L *

NOAEC: <1.4 μg/L *

(based on biomass ) 467085

- 10 Supplemental

Aquatic

– Vascular

Plants

850.4400

Tier I I Duckweed ( Lemna gibba ) TGAI

7

- day EC 50 : >3200 μg/L *

NOAEC: 3200 μg/L * ( no effects ) 467085

- 07 Acceptable

Degradate BAM

Acute

– Freshwater

Fish

850.1075 Rainbow trout (Oncorhynchus mykiss ) 96

- hr LC 50 : 246,000 μg/L Practically non

- toxic 467084

- 36 Acceptable

Chronic

– Freshwater

Fish

850.1400 Rainbow trout (Oncorhynchus mykiss ) NOAEC = 10,000 μg/L LOAEC = 18,000 μg/L (based on 60

- day survival, length,

and weight) 00156312 Supplemental

Acute

– Freshwater

Invertebrate

850.1010 Water flea ( Daphnia magna ) 48

- hr EC 50 : 184,1 00 μg/L NOAEC: 101,000 μg/L

Practically non

- toxic 467084

- 32 Acceptable

Chronic

– Freshwater

Invertebrate

850.1300 Water flea ( Daphnia magna ) NOAEC: 320,000 μg/L LOAEC: >320,000 μg/L (based on reproduction and 21

- day survival) 00156312 Supplemental

Aquatic

– Non

vascular Plants

850.4500

Tier I I Freshwater diatom ( Navicula pelliculosa ) 96

- hour EC 50 : >10,000 μg/L NOAEC: 10,000 μg/L ( no effects ) 467085

- 11 Acceptable

Degradate 3

- chloro

- 5

- trifluoromethylpyridine

- 2

- carboxylic acid

Acute

– Freshwater

Fish

850.1075 Rainbow trout (Oncorhynchus mykiss ) 96

- hr LC 50 : 102,000 μg/L NOAEC: 102,000 μg/L

Practically non

- toxic 467084

- 43 Acceptable

* Most sensitive endpoint; w ill be used for risk quantification, as appropriate. TGAI = Technical grade active ingredient



### 4.2. Effects to Terrestrial Organisms

Table 7 summarizes the terrestrial toxicity data for fluopicolide and the degradate BAM

. F luopicolide is practically non

- toxic to birds and mammals on an acute basis. Chronic effects

were redu ctions in hatchling body weight and the proportion of hatchl ing survivors to number hatched for bobwhite quail and reductions in viable embryos, live embr yos, number hatched, the ratios of number hatched to eggs laid and set, hatchling survival, and the proportion of survivors to eggs set for ma llard duck

. Fluopicolide is practically non

- toxic to honey bees. In the seedling emergence study, no effects were observed for monocots and the only dicot affected was

buckwheat

. However, the study was not conducted at the maximum labeled single application rate. In the vegetative vigor study, no effects were observed for dicots and the only monocot

### 15 affected was ryeg rass. However, the study was not conducted at the maximum labeled single application rate. BAM i s more acutely toxic to mammals than fluopicolide

.

Table 7. Summary of Toxicity Studies of Fluopicolide and the Degradate BAM to Terrestrial Organisms
Study Type Species Toxicity Value & Category MRID & Status Parent Fluopicolide

Acute

– Avian Oral

850.2100 Bobwhite Quail (Colinus virginianus ) LD 50 : >225 0 mg/kg

- bw/day NOAEL: 2250 mg/kg

- bw/day Practically non

- toxic 467084

- 48 Acceptable

Acute

– Avian Oral

850.2100 Mallard Duck ( Anas platyrhynchos ) LD 50 : >225 0 mg/kg

- bw/day NOAEL: 2250 mg/kg

- bw/day Practically non

- toxic 467084

- 47 Acceptable

Acute

– Avian Dietary

850.2200 Bobwhite Quail (Colinus virginianus ) LC 50 : >579 0 mg/kg

- diet NOAEC: 1780 mg/kg

- diet (based on body weight gain) Practically non

- toxic 467085

- 01 Acceptable

Acute

– Avian Dietary

850.2200 Mallard Duck ( Anas platyrhynchos ) LC 50 : >579 0 mg/kg

- diet NOAEC: 3300 mg/kg

- diet (based on body weight gain) Practically non

- toxic 467084

- 49 Acceptable

Chronic

– Avian

Reproduction

850.2300 Bobwhite Quail (Colinus virginianus ) NOAEC: 162 mg/kg

- diet *

LOAEC: 404 mg/kg

- diet ( based on hatchling body weights

and the proportion of hatchling

survivors to number hatched ) 467085

- 03 Acceptable

Chronic

– Avian

Reproduction

850.2300 Mallard Duck ( Anas platyrhynchos ) NOAEC: 162 mg/kg

- diet *

LOAEC: 404 mg/kg

- diet ( based on proportion of eggs set to eggs laid and eggshell thickness ) 467085

- 02 Acceptable

Acute

– Mammalian

Oral

870.1100 Rat ( Rattus norvegicus ) LD 50 : >2 000 mg/kg

- bw Practically non

- toxic 467099

- 03 Acceptable

Acute

- Mammalian

Inhalation

870.1300 Rat ( Rattus norvegicus ) LC 50 : >1.789 mg/L 467099

- 05 Acceptable

Chronic

– Mammalian Reproduction

870.3800 Rat ( Rattus norvegicus ) NOA EC: 500 mg/kg

- diet *

LOAEC: 2000 mg/kg

- diet (based on decreased body weight and organ weight changes in F0, F1, and F2 pups ) 464741

- 24

464741

- 25 Acceptable

Acute

– Contact Toxicity

850.3020 Honey Bee ( Apis mellifera ) L D 50 : >100 μg/bee NOAEL: 100 μg/bee Practically non

- toxic 467085

- 04 Acceptable

Seedling Emergence

Tier I

850.4100 Dicots: buckwheat, cucumber, soybean, sunflower, tomato, turnip

Monocots: corn, onion, ryegrass, wheat TEP

Dicot: EC 25 : >0.121 lb ai /acre

NOAEC: <0.121 lb ai /acre * (based on buckwheat shoot height)

Monocot: EC 25 : >0.121 lb ai /acre

NOAEC : 0.121 lb ai /acre * (no effects) 467085

- 05 Supplemental

### 16 Study Type Species Toxicity Value & Category MRID & Status Vegetative Vigor

Tier I

850.4150 Dicots: buckwheat, cucumber, soybean, sunflower, tomato, turnip

Monocots: corn, onion, ryegrass, wheat TEP

Dicot: EC 25 : > 0.121 lb ai /acre

NOAEC: 0.121 lb ai /acre * (no effects)

Monocot: EC 25 : >0.121 lb ai /acre

NOAEC: <0.121 lb ai /acre * (based on ryegrass dry weight) 467085

- 05 Supplemental

Degradate BAM

Acute

– Mammalian

Oral

870.1100 Rat ( Rattus norvegicus ) LD 50 : 1470 mg/kg

- bw * Slightly toxic 00111402

Not classified

Seedling Emergence

Tier I I

850.4100 Dicots: cucumber, oilseed rape, pea, soybean, sugar

beet

Monocots: corn, oat, onion Dicot: EC 25 : >11.640 μg/kg

- soil 1
NOAEC: 11.640 μg/kg

- soil 1

(no effects)

Monocot: EC 25 : 6.3 μg/kg

- soil 1

NOAEC: 0.722 μg/kg

- soil 1
(based on onion dry weight) 467085

- 06 Acceptable

* Most sensitive endpoint; w ill be used for risk quantification, as appropriate. TEP: Typical end

- use product

1 Assuming 907,185 kg soil in an acre:

Dicot: EC 25 : >11.640 μg/kg

- soil >23.28 lb BAM /acre NOAEC: 11.640 μg/kg

- soil 23.28 lb BAM /acre

Monocot: EC 25 : 6.3 μg/kg

- soil 12.6 lb BAM /acre NOAEC: 0.722 μg/kg

- soil 1.444 lb BAM /acre



### 4.3. Incident Databases Review

No incidents involving fluopicolide were reported as of November 6, 2012 in the Ecological Incident Information System ( EIIS ) maintained by the Environmental Fate and Effects Division, the Aggregate Summary Module (ASM) o f Office of Pesticide Program’s Incident database maintained by the Information Technology and Resource Management Division, or the Avian Incident Monitoring System (AIMS) 9



### . It should be noted that a lack of reported incidents does

not indicat e little or no ecological risk

.

5 . Conceptual Model

The conceptual model for fluopicolide provides a written description and visual representation of the predicted relationships between fluopicolide , potential routes of exposure, and the predicted

effects for the assessment endpoints. A conceptual model consists of two major components: risk hypothesis and a conceptual diagram (USEPA, 1998).

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

### 17 For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of

expo sure for ecological receptors, and a feasible route of exposure.

5 .1. Risk Hypothesis

Based on the application methods, mode of action, fate and transport, and the sensitivity of non

target aquatic and terrestrial species, fluopicolide and the major degra date BAM have the potential to reduce survival, reproduction, and/or growth of non

- target terrestrial and aquatic organisms when used in accordance with the current labels. These non

- target organisms include Federally

- listed threatened and endangered species as well as non

- listed species.

5 .2. Conceptual Diagram

In addition to direct spray, t he environmental fate properties of fluopicolide indicate that runoff

and spray drift represent potential transport mechanisms of fluopicolide to aquatic and terrestrial

habitats where non

- target organisms may be exposed. These transport mechanisms are depicted in the conceptual models b elow ( Figures 4, 5

, and 6 ) along with the receptors of concern and the potential attribute changes in the receptors due to exposure to fluopicolide

.

### 18 Figure 4 . Conceptual Model for Exposu re and Effects of Fluopicolide to Aquatic Organisms. Dotted Lines Indicate Exposure Pathways that Have a Low Likelihood of Contributing to Ecological Risk.

*Leaching potential based on Koc but available terrestrial field dissipation studies showed little l eaching.

** Route of exposure includes only ingestion of fish and aquatic invertebrates 

### Stressor

Source

Receptors

Attribute Change Fluopicolide applied to use site

Spray drift

Aquatic animals

Invertebrates

Vertebrates
Piscivorous mammals

and birds **

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae and

vascular plants Reduction in prey
Modification of PCEs

related to prey availability Habitat integrity Reduction in primary productivity

Reduced cover Community change
Modification of PCEs related to

habitat Surface water/

Sediment Runoff

Aquatic Animals

Invertebrates
Vertebrates 

### Exposure

Media

Uptake/gills or integument

Ingestion Ingestion Atmospheric transport

Wet/dry deposition Soil Leaching to
Groundwater *

Uptake/gills or integument

Aquatic Plants

Non

- vascular
Vascular Uptake/cell, roots, leaves Riparian plants

terrestrial

exposure pathways see

Figure 6.2

### 19 Figure 5 . Conceptual Model for Exposure and Effects of Fluopicolide to Terrestrial Organisms. Dotted Lines Indicate Exposure Pathways that Have a Low Likelihood of Contributing to Ecological Risk.

Stressor

Source

Attribute Change Fluopicolide applied to use site

Direct application Spray drift

Terrestrial

vertebrates* Terrestrial

Inverts*

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain

Reduction in prey and
food
Modification of PCEs

related to prey availability Habitat integrity Reduction in primary productivity

Reduced cover Community change
Modification of PCEs related

to habitat Terrestrial plants grasses/forbs, fruit, seeds (trees, sh rubs) Runoff

Terrestrial

vertebrates* * 

### Exposure Media & Receptors Soil

Ingestion Ingestion Dermal uptake/Ingestion Atmospheric transport

Root uptake/contact

Wet/dry deposition

Ingestion Leaching to
Groundwater * Irrigation

water

* Leaching potential based on Koc but available terrestrial field dissipation studies showed little leaching. ** See Figure 6 for drinking water and inhalation exposure pathways for terrestrial vertebrates and ingestion of residues in dew by terrestrial invertebrates.

### 20 Figure 6 . Conceptual Model for Drinking Water and Inhalation Exposure Pathways for Terrestrial Vertebrates and Ingestion of Residues in Dew by Terrestrial Invertebrates. Dotted Lines Indicate Exposure Pathways that Have a Low Likelihood of Contributing to Ecological Risk.

6 . Analysis Plan

In order to address the risk hypothesis, the potential for adverse effects on the environment will be estimated. The use, environmental fate, and ecological effects of fluopicolide and BAM will be characterized and integrated to assess the potential for risk.

This analysis plan may be revised depending upon a full review of the data available in the open literature and the information submitted by the public in response to the opening of the registration review docket.

6 .1. Stressors of Concern

Fluopicolide and its major degradate

, BAM (formed 40.2% in an aerobic soil metabolism study),

will be considered as the stressors of concern. Available fate data suggests that BAM is persistent like fluopicolide but more mobile. Available toxicity data suggests that BAM is less Stressor

Sour ce

Attribute Change Fluopicolide applied to use site

Direct application Spray drift

Terrestrial

vertebrates Terrestrial
invertebrates

Individual organisms

Reduced survival Reduced growth

Reduced reproduction Food chain Reduction in prey and
food
Modification of PCEs

related to prey availability Habitat integrity Reduction in primary productivity

Reduced cover Community change
Modification of PCEs related

to habitat Runoff



### Exposure Media Dew (formed on terrestrial plants) Atmospheric transport



### Receptors Puddles (formed on treated fields)

Imbibition Inhalation Air

### 21 toxic than fluopicolide to aquatic organisms and terrestrial plants but more acutely toxic to

mammals. Therefore, the potential for risk to mammals due to exposure to BAM will be assessed separately from fluopicolide. The toxicity of BAM to birds is unknown due to lack of data, but it

will be assumed that BAM toxic ity to birds is similar to that o f mammals. For all other taxa, only fluopicolide risk will be assessed.

The Agency does not routinely include, in its risk assessments, an evaluation of mixtures of active ingredients, either those mixtures of multiple active ingredients in product formu lations or those in the applicator’s tank. In the case of the product formulations of multiple active ingredients (that is, a registered product containing more than one active ingredient), each active ingredient is subject to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing more than one active ingredient, they may be used qualitatively or quantitatively in accordance with the Ag ency’s Overview Document and the Servic es’ Evaluation Memorandum (US EPA

, 2004; USFWS/NMFS

, 1998 ).

6 .2. Measures of Exposure

There is potential for exposure to non

- target organisms through consumption of contaminated food items ( e.g., treated insects or vegetation), direct application, runoff, and spray drift. Fluopicol i de concentrations in aquatic and terrestrial environments will be modeled using the maximum labeled application rates, the maximum number of applications, the minimum application intervals, and application methods that have the greatest potential for off

- sit e transport. Additionally, the Agency will assess available monitoring data.

Aquatic Exposure

T ier II models PRZM ( P esticide R oot Z one M odel, v3.12.3; June, 2006 ) and EXAMS ( EX posure A nalysis M odeling S ystem, version 2.98.04.06, April 2005) in the PE5 shell 10 

### will be used to estimate environmental concentrations (EECs) of fluopicolide in surface waters.

Terrestrial Exposure

T

- REX (v 1.5) 11 

### will be used to estimate avian and mammal exposure to fluopicolide

. The

default 35

- day foliar dissipation half

- life will be used. If risk quotients exceed levels of concern

, the foliar dissipation half

- life may be refined using available magnitude of residue studies.

TerrPlant (v 1.2.2) 1 1 

### will be used to calculate EECs for characterizing exposure to terrestrial and

semi

- aquatic plants.

Fluopicolide is a systemic compound and the exposure models ( T

- REX and TerrPlant ) do not account for residues found in plant material ( i.e., leaves, stems, stalks, seeds, pollen, and nectar)

. Therefore, exposure to these translocated residues is uncertain for birds, mammals, and insects

such as bees that consume plant materials

. The Agency seeks comments from the public on

10 http:// www.epa.gov /oppefed1/models/water

11 http:// www.epa.gov/oppef ed1/models/terrestrial

### 22 estimating exposure and characterizing risk to terrestrial organisms due to exposure to translocated residues in plant materials.

The Screening Imbibition Program (SIP v.1.0) is used during the problem formulation phase of Registration Review to provide an upper

- bound estim ate of exposure to birds and mammals from pesticides through drinking water alone. SIP was not used b ecause avian and mammalian acute

toxic ity values were non

- definitive . It is assumed that acute and chronic exposure through drinking water alone would no t be a concern for birds and mammals for fluopicolide

. However, a potential acute concern was identified for mammals exposed to BAM ( Appendix A ).

The Screening Tool for Inhalation Risk (STIR v.1.0) is used during the problem formulation phase of Registra tion Review to assess the potential for exposure and risk to bird s and mammals through inhalation of fluopicolide . The exposure pathways that are assessed by this tool include both droplet inhalation and vapor phase inhalation. STIR was not used b ecause a vian and mammalian acute toxicity values were non

- definitive . I t is assumed that exposure through inhalation would not be a concern for birds and mammals (acute rat inhalation LC 50 

### > 1.789 mg/L; MRID 467099

- 05 ).

6 .3. Measures of Effect

Toxicity effects data will be used as measures of direct and indirect effects to biological receptors (USEPA, 2004). As discussed previously, data will be obtained from registrant

submitted studies and from literature studies identified in ECOTOX.

Quan titative assessment of risks will be based on study endpoints that can be directly linked to the Agency’s assessment endpoints of impaired survival, growth, and reproduction. Sub

- lethal effects ( e.g. lethargy and changes in coloration) will be evaluated q ualitatively. Available

incident data will be used to further characterize risk.

The assessment of risk for direct effects to non

- target organisms will make the assumption that

the toxicity of fluopicolide to birds is similar to ter restrial

- phase amphibians and reptiles. The same assumption will be made for fish and aquatic

- phase amphibians.

6 .4. Integration of Exposure and Effects

T he risk quotient (RQ) method will be used to compare exposure and measured toxicity values. Exposu re estimates will be divided by acute and chronic toxicity values. The resulting RQs will

then be compared to the Agency’s Levels of Concern (LOCs). In ad dition, other lines of

evidence will be considered, such as reported incidents

. These criteria are used to indicate when

the use of fluopicolide , as directed on the labels, has the potential to cause adverse direct or

indirect effects to non

- target organisms.

6 .5. Deterministic and Probabilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the deterministic point

- estimate based approach described in the risk assessment. Depending on the risk manager’s need for

### 23 additional information regarding risk, an effort may be made to further describe risk usi ng probabilistic tools that the Agency has developed. These tools have been reviewed by FIFRA Scientific Advisory Panels 12 

### and have been deemed as appropriate means of refining assessments where deterministic approaches have identified risks.

6 .6. Endange red Species Assessment

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to Federally

- listed threatened and/or endangered (listed) species from registered uses of fluopicolide . This assessme nt will be conducted i n accordance with the Overview Document (USEPA, 2004), provisions of ESA, and the Services’ Endangered Species

Consultation Handbook (USFWS/NMFS, 1998).

6 .7. Endocrine Disruptor Screening Program

As required by Federal Food, Drug and Cosmetic Act (FFDCA) section 408(p), fluopicol i de is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP) 13



### . Fluopicolide is not in the first or second group s of pesticide active ingredients to be screened

under the EDSP.

6 .8. Drinking Water Assessment

The last DWA was conducted in 2010 (DP 370764)

. A DWA will be conducted to support the future human health dietary risk assessment of fluopicolide in registration review

. Among other update s, the DWA will include identified uses with higher application rates than previously

assessed and incorporate recently available fate data for BAM. The DWA will incorporate model estimates of fluopicolide and BAM, the major degradate of conce rn, in surface water and ground water. BAM will be assessed separately because the compound has toxicity endpoints that are different from those of fluopicolide and dichlobenil (PC code 027401), which also degrades to BAM.

Fluopicolide and BAM s urface water c oncentrations will be estimated using PRZM /EXAMS and

g round water concentrations will be estimated using t he Screening Concentration in Ground Water (SCI

- GROW, v2.3) model and the PRZM

- GW model 14 

### . The DWA will also include a summary of available sur face and ground water monitoring data

.

7

. Preliminary Identification of Data Gaps

Available studies submitted to fulfill environmental fate and ecological effects guideline requirements, as well as outstanding data gaps for fluopicolide , are defined in Sections 7

. 1 and

7. 2

.

12 http://www.epa.gov/scipoly/sap/index.htm

13 http://www.epa.gov/endo/

14 http://www.epa.gov/oppefed1/models/water/

### 24 7

. 1 . Fate Data Gaps

Table 8 lists the status of the fate and transport data requirements for fluopicolide

. BAM was identified as a major degradate (formed > 40.2% in an aerobic soil metabolism study) of fluopicolide. Available data suggests that BAM is persistent like fluopicolide but more mobile. Currently, EFED has an invalid aerobic aqu atic metabolism study with BAM. Acceptable data

are important because BAM is a residue of concern in fluopicolide and dichlobenil drinking water assessments. EFED will assume that BAM is stable to aerobic aquatic metabolism in the

absence of data. EFED does not recommend requesting additional data that is likely to confirm

that BAM is stable.

Table 8 . Environmental Fate Data and Data Gaps for Fluopicolide

Guideline Description MRID Classification Data
Gap? Comments

835.2120 Hydrolysis 46708420 Acceptable No 1 Although the data requirement is not filled, additional data are not expected to substantially change the study results. EFED

does not recommend requesting additional

data.

2 These data are required under 40 CFR part 158 for terrestrial

outdoor uses. Fluopicolide will be

considered stable i n the

absence of data (consistent with other fate data). EFED does

not recommend requesting data if it is likely confirm that fluopicolide is stable.

3 The available study

tested one sediment

type; two are
recommended. It is unlikely that additional

data will demonstrate that fluopicolide is not

stable. Therefore,

EFED does not recommend requesting

additional data. 835.2240 Aqueous Photolysis 46708422 Acceptable No

835.2410 Soil Photolysis 46708424

46708425 Acceptable
Supplemental No

835.4100 Aerobic Soil Metabolism 46708427

46708428 Supplemental Acceptable Yes `1

835.4200 Anaerobic Soil

Metabolism See

46708429 - No

835.4300 Aerobic Aquatic

Metabolism - - Yes 2

835.4400 Anaerobic Aquatic

Metabolism 46708429 Acceptable Yes 3

835.1230

835.1240 Leaching
Adsorption/Desorption 47040401 Acceptable No

835.6100 Terrestrial Field
Dissipation 46708430 Acceptable No

850.1730 Accumulation in Fish 46708446 Acceptable No

### 25 7. 2 . Effects Data Gaps

The status of effects data requirements are listed in Tables 9 to 1 1

. While an acute avian study for the degradate BAM would reduce uncertainties, in the absence of data, EFED will assume

that BAM toxicity to birds is similar to that of mammals.

Table 9 . Terrestrial Animal Toxicity Data and Data Gaps for Fluopicolide

Guideline Description MRID Classification Data Gap? Comments

850.2100 Avian oral toxicity 467084

- 48 Acceptable

Yes Acceptable avian data were

submitted for the bobwhite quail and mallard duck. However, avian acute oral toxicity data are not available for passerines, which are required under 40 CFR Part

158. Passerine birds may utilize metabolic pathways that are different from larger birds. In addition, avian estimated

environment al doses are not expected to be at least 10 times lower than the highest dose

tested for some of the non

agricultural use patterns. Therefore, EFED recommends requesting a study conducted

with the TGAI. 467084

- 47 Acceptable

850.2200 Avian dietary toxicity 467085

- 01 Acceptable No

-- 467084

- 49 Acceptable

850.2300 Avian reproduction 467085

- 03 Acceptable No

-- 467085

- 02 Acceptable

850.3020 Honeybee acute contact toxicity 467085

- 04 Acceptable No

--

870.1100 Mammalian oral toxicity 467099

- 03 Acceptable No

--

870.3800 Mammalian reproduction toxicity 464741

- 24

464741

- 25 Acceptable No

--

870.1300 Mammalian inhalation toxicity 467099

- 05 Acceptable No

--

TGAI: Technical grade active ingredient

### 26 Table 10 . Aquatic Animal Toxicity Data and Data Gaps for Fluopicolide

Guideline Description MRID Classification Data Gap? Comments

850.1075 Freshwater fish

– Acute toxicity 467084

- 38

467084

- 37

467084

- 39

467084

- 40

467084

- 41 Acceptable Acceptable Acceptable Acceptable Acceptable No

--

850.1075 Estuarine/marine

fish

– Acute toxicity 467084

- 42 Acceptable No

--

850.1010 Freshwater

invertebrates

– Acute toxicity 467084

- 33 Acceptable No

--

850.1025

850.1035 Estuarine/marine

invertebrates

– Acute toxicity 467084

- 34 Acceptable No

--

457084

- 35 Acceptable No

--

850.1400 Freshwater fish

– early life stage test 467084

- 45 Acceptable No

--

850.1400 Estuarine/marine

fish

– early life stage test Not

submitted Not applicable Yes To utilize the acute to chronic ratio to predict chronic toxicity to estuarine/marine fish, both acute and chronic toxicity values are needed

for freshwater fish for the same species. EFED recommends requesting e ither a chronic estuarine/marine toxicity te st or an acute fathead minnow toxicity test. The study should be conducted with

the TGAI.

850.1300 Freshwater

invertebrate

– life cycle test 467084

- 44 Acceptable No

--

850.1350 Estuarine/marine

invertebrates

– life cycle test Not

submitted Not applicable Yes The acute to chronic ratio cannot be utilized to predict chronic toxicity to

estuarine/marine invertebrates because the acute freshwater toxicity

value is non

- definitive. Therefore, EFED recommends requesting a chronic estuarine/marine invertebrate toxicity test conducted with the

TGAI.

TGAI: Technical grade active ingredient

### 27 Table 1 1 . Available Plant Toxicity Data and Data Gaps for Fluopicolide

Guideline Description MRID Classification Data Gap? Comments

850.4100 Terrestrial Plant toxicity:

S eedling emergence 467085

- 05 Supplemental Yes Definitive NOAECs could not

be established for dicots in the seedling emergence study

and monocots in the vegetative vigor study. In addition, the studies were not

conducted at the maximum labeled single application rate. Therefore, EFED

recommends new studies. The

studies should be conducted

with a TEP. 850.4150 Terrestrial Plant toxicity:

V egetative vigor 467085

- 05 Supplemental Yes

850.45 00 &

850.4550 Aquatic Plant Growth: algae 467086

- 49 Supplemental Yes The data requirement is satisfied by MRID 467086

- 09.

467086

- 09 Acceptable No

--

467086

- 08 Acceptable No

--

Not

submitted Not Applicable Yes A freshwater diatom ( Navicula pelliculosa ) study

has not been submitted

. EFED recommends requesting a study conducted

with the TGAI.

467085

- 10 Supplemental Yes A definitive NOAEC could

not be established for the marine diatom ( Skeletonema

costatum ) due to effects occurring at the lowest test concentration. Therefore,

EFED recommends requesting a new study, which

should be conducted with the

TGAI.

850.4400 Aquatic Plant Growth: vascular plants 467085

- 07 Acceptable No

--

TEP: Typical end

- use product TGAI: Technical grade active ingredient

### 28 8. References

USEPA. 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Offic e of Research and Development, Washington, 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 the Office of Pesticide Programs. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington DC. January 23, 2004.

USFWS and NMFS. 1998. Endangered Species Consultation Handbook: Procedures for Conducting Consultation and Conferenc e Activities Under Section 7 of the Endangered Species Act. Final Draft. March 1998.

### 29 Appendix A. SIP Results for Degradate BAM

Table 1. Inputs

Parameter Value

Chemical name BAM
Solubility (in water at 25 o C; mg/L) 2700

Mammalian LD 50 (mg/kg

- bw) 1470
Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 0 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 0 Avian test species Body weight (g) of "other" avian species Mineau scaling factor

Mallard NOAEC (mg/kg

- diet) 0 Bobwhite quail NOAEC (mg/kg

- diet) 0 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Upper bound exposure (mg/kg

- bw) 464.4000 Adjusted toxicity value (mg/kg

- bw) 1130.6660 Ratio of exposure to toxicity 0.4107

Conclusion* Exposure through drinking water alone is a

potential concern for

mammals

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals.