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 Avenue, 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

H2

F

F

F

N

H

O Cl

Cl
2

Table of Contents

1. Purpose....................................................................................................................................... 3

2. Problem Formulation ................................................................................................................. 3

2.1. Nature 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. Receptors.................................................................................................................................. 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. Stressors 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 Results 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 

assessments 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 uses of fluopicolide.

2. Problem Formulation

2.1. Nature of Regulatory Action

As part of the implementation of the new Registration Review program1 pursuant to Section 3(g) 

of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the United States 

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 fluopicolide 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 assessments (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). Additionally, 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 registered for agricultural and non-agricultural use. The formulated 

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 application 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 Rates 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 0.125 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 nonflowering plants, 

ornamental woody 

shrubs and vines

G

(Soil drench treatment) 27.133 2 NS

(54.266)

NS

(7)

Golf course turf, 

commercial/

industrial lawns, 

ornamental sod farm 

(turf), recreation 

area lawns, 

residential lawns

G

(Chemigation, spray) 0.271 NS

(2)1 0.5421 14

Ornamental lawns 

and turf

G

(Broadcast, 

chemigation)

0.268 NS

(2)1 0.5361 NS

(7 days)

NA = Not applicable. NS = Not specified; numbers 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 time, it will be assumed that the interval stays the same. 
6

Fluopicolide usage 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 applied 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 spatially 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 (2008-2011)

Figure 2. Agricultural Usage Data for Fluopicolide Top Crops (2008-2011)
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 20o C) and Henry's Law Constant (3.84 x 10-5 Pa m3 mol-1

) 

indicate a low possibility of volatilization 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% applied) and three minor (PCA, AE 

060800003

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

adsorption coefficient for fluopicolide (mean Koc = 340) suggests that leaching could be a route 

of dissipation. The available terrestrial 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 day). Consistent with laboratory data, 

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

186x 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, aqueous photolysis, and aerobic soil 

metabolism. Vapor pressure (4.3 x 10-4 Pa) and Henry's Law Constant (1.2 x 10-4 Pa m3 mol-1) 

indicate a low possibility of volatilization 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 physical, 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 C14H8Cl3F3N2O

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

H2

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·m3/mol Calculated

Persistence

Hydrolysis (pH 5, 7, and 9) Stable1 MRID 46708420 Acceptable

<1% decline at 30 days

Aqueous Photolysis (t 1⁄2 ) Stable1 MRID 46708422 Acceptable

t1/2 = 170 days 

Soil Photolysis (t 1⁄2 ) Stable1 MRID 46708424

MRID 46708425

Acceptable

t1/2 = 80 days

Supplemental 

t1/2 = 182 days

Aerobic Soil Metabolism (t 1⁄2 ) Stable1 MRID 46708427

MRID 46708428

Supplemental 

DT50 >120 days

Acceptable

t1/2 = 391, 458 days 

Anaerobic Aquatic Metabolism (t 1⁄2 ) Stable1 MRID 46708429 Acceptable

System DT50>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] 

benzamide1

-- 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 HSDB1

Empirical Formula C7H5Cl2NO

CAS Number 2008-58-4

Structure

SMILES Clc2cccc(Cl)c2C(=O)N

Selected Physical/Chemical Parameters

Molecular mass 190.03 HSDB1

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·m3/mol

Persistence

Hydrolysis (pH 5, 7, and 9) Stable2 MRID 46708419 Supplemental

<3% decline at 30 days 

(pH 7)

Aqueous Photolysis (t 1⁄2 ) Stable2 MRID 45280303 Acceptable

No degradation at 31 

days 

Aerobic Soil Metabolism (t 1⁄2 ) Stable2 MRID 45575901 Acceptable

t1/2 = 1430 and 1780 days 

O Cl

Cl

N2H
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) has 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 Process7

, 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 (USEPA, 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 to 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) database8

, 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. Fluopicolide is moderately to highly acutely 

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

estuarine/marine invertebrates. Chronic effects to freshwater fish included effects on larval 

length at 294 μg/L. Chronic 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 concentration 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 organisms.

 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), there 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 LC50: 349 μg/L*

NOAEC: 152 μg/L

Highly toxic

467084-38

Acceptable

Acute – Freshwater 

Fish

850.1075

Bluegill sunfish

(Lepomis macrochirus)

96-hr LC50: 720 μg/L

NOAEC: 540 μg/L

Highly toxic

467084-37

Acceptable

Acute – Freshwater 

Fish

850.1075

Common carp

(Cyprinus carpio)

96-hr LC50: 1300 μg/L

NOAEC: 250 μg/L

Moderately toxic

467084-39

Acceptable

Acute – Freshwater 

Fish

850.1075

Ricefish

(Oryzias latipes)

96-hr LC50: 670 μg/L

NOAEC = 420 μg/L

Highly toxic

467084-40

Acceptable

Acute – Freshwater 

Fish

850.1075

Zebra fish

(Brachydanio rerio)

96-hr LC50: 1700 μg/L

NOAEC: 960 μg/L

Moderately toxic

467084-41

Acceptable

Chronic – Freshwater 

Fish

850.1400

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 LC50: 410 μg/L*

NOAEC: 200 μg/L

Highly toxic

467084-42

Acceptable

Acute – Freshwater 

Invertebrate

850.1010

Water flea 

(Daphnia magna)

48-hr EC50: >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 EC50: >2600 μg/L*

NOAEC: 2600 μg/L

Moderately toxic 

467084-34

Acceptable

Acute –

Estuarine/Marine 

Invertebrate

850.1035

Mysid shrimp 

(Americamysis bahia)

96-hr LC50: 3200 μg/L*

NOAEC: 1600 μg/L

Moderately toxic

457084-35

Acceptable

Aquatic – Nonvascular Plants

850.4500 & 

850.4550

Green algae 

(Pseudokirchneriella 

subcapitata)

Tier I TGAI

96-hour EC50: >1800 μg/L

96-hour EC05: < 1800 μg/L

NOAEC: <1800 μg/L

(based on cell density)

467086-49

Supplemental

Green algae

(Pseudokirchneriella 

subcapitata)

Tier II TGAI

96-hour EC50: 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 EC50: >2200 μg/L

NOAEC: 2200 μg/L

(no effects)

467086-08

Acceptable

Marine diatom

(Skeletonema costatum)

Tier II TGAI

96-hour EC50: 51 μg/L*

96-hour EC05: <1.4 μg/L*

NOAEC: <1.4 μg/L*

(based on biomass)

467085-10

Supplemental

Aquatic – Vascular 

Plants

850.4400

Tier II

Duckweed 

(Lemna gibba)

TGAI

7-day EC50: >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 LC50: 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 EC50: 184,100 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 – Nonvascular Plants

850.4500

Tier II

Freshwater diatom

(Navicula pelliculosa)

96-hour EC50: >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 LC50: 102,000 μg/L 

NOAEC: 102,000 μg/L

Practically non-toxic

467084-43

Acceptable

*Most sensitive endpoint; will 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. 

Fluopicolide is practically non-toxic to birds and mammals on an acute basis. Chronic effects 

were reductions in hatchling body weight and the proportion of hatchling survivors to number 

hatched for bobwhite quail and reductions in viable embryos, live embryos, number hatched, the 

ratios of number hatched to eggs laid and set, hatchling survival, and the proportion of survivors 

to eggs set for mallard 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 ryegrass. However, the study was not conducted at the maximum labeled single 

application rate. BAM is 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)

LD50: >2250 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)

LD50: >2250 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)

LC50: >5790 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)

LC50: >5790 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)

LD50: >2000 mg/kg-bw

Practically non-toxic

467099-03

Acceptable

Acute - Mammalian

Inhalation

870.1300

Rat

(Rattus norvegicus) LC50: >1.789 mg/L 467099-05

Acceptable

Chronic –

Mammalian 

Reproduction

870.3800

Rat 

(Rattus norvegicus)

NOAEC: 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)

LD50: >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: EC25: >0.121 lb ai/acre

NOAEC: <0.121 lb ai/acre*

(based on buckwheat shoot height)

Monocot: EC25: >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: EC25: >0.121 lb ai/acre

NOAEC: 0.121 lb ai/acre*

(no effects)

Monocot: EC25: >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)

LD50: 1470 mg/kg-bw*

Slightly toxic

00111402

Not classified

Seedling Emergence

Tier II

850.4100

Dicots: cucumber, oilseed 

rape, pea, soybean, sugar 

beet

Monocots: corn, oat, onion

Dicot: EC25: >11.640 μg/kg-soil1

NOAEC: 11.640 μg/kg-soil1

(no effects)

Monocot: EC25: 6.3 μg/kg-soil1

NOAEC: 0.722 μg/kg-soil1

(based on onion dry weight)

467085-06

Acceptable

*Most sensitive endpoint; will be used for risk quantification, as appropriate. 

TEP: Typical end-use product 1

Assuming 907,185 kg soil in an acre: 

 Dicot: EC25: >11.640 μg/kg-soil >23.28 lb BAM/acre

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

 Monocot: EC25: 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) of 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 indicate 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 

exposure 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 nontarget aquatic and terrestrial species, fluopicolide and the major degradate 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, the 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 below (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 Exposure 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 leaching.

**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, shrubs)

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

Source

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)

Inhalation Imbibition

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 toxicity to birds is similar to that of 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 formulations 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 Agency’s Overview Document and the Services’ Evaluation Memorandum 

(USEPA, 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. 

Fluopicolide 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-site 

transport. Additionally, the Agency will assess available monitoring data.

Aquatic Exposure 

Tier II models PRZM (Pesticide Root Zone Model, v3.12.3; June, 2006) and EXAMS (EXposure 

Analysis Modeling System, version 2.98.04.06, April 2005) in the PE5 shell10 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)11 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/oppefed1/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 estimate of exposure to birds and mammals from

pesticides through drinking water alone. SIP was not used because avian and mammalian acute 

toxicity values were non-definitive. It is assumed that acute and chronic exposure through 

drinking water alone would not 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 Registration Review to assess the potential for exposure and risk to birds 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 because avian and 

mammalian acute toxicity values were non-definitive. It is assumed that exposure through 

inhalation would not be a concern for birds and mammals (acute rat inhalation LC50 > 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 registrantsubmitted studies and from literature studies identified in ECOTOX. 

Quantitative 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 qualitatively. 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 terrestrial-phase amphibians and reptiles. The 

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

6.4. Integration of Exposure and Effects

The risk quotient (RQ) method will be used to compare exposure and measured toxicity values. 

Exposure 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 addition, 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 using 

probabilistic tools that the Agency has developed. These tools have been reviewed by FIFRA 

Scientific Advisory Panels12 and have been deemed as appropriate means of refining assessments 

where deterministic approaches have identified risks.

6.6. Endangered 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 assessment will be conducted in 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), fluopicolide is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP)13. 

Fluopicolide is not in the first or second groups 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 

updates, 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 concern, 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 surface water concentrations will be estimated using PRZM/EXAMS and 

ground water concentrations will be estimated using the Screening Concentration in Ground 

Water (SCI-GROW, v2.3) model and the PRZM-GW model14. The DWA will also include a 

summary of available surface 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 aquatic 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 in 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 11. 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 

environmental doses are not 

expected to be at least 10 times 

lower than the highest dose 

tested for some of the nonagricultural 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 either a chronic 

estuarine/marine toxicity test 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 11. Available Plant Toxicity Data and Data Gaps for Fluopicolide

Guideline Description MRID Classification Data Gap? Comments

850.4100

Terrestrial Plant 

toxicity: 

Seedling 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: 

Vegetative vigor

467085-05 Supplemental Yes

850.4500 & 

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, Office 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 Conference 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 25oC; mg/L) 2700

Mammalian LD50 (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 LD50 (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.