1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CEMICAL SAFETY AND 

POLLUTION PREVENTION

PC Code: 080302

DP Barcode: 414232

June 25, 2014

MEMORANDUM

SUBJECT: Ecological Risk Assessment for Proposed Section 3 New Use for Fluopyram for 

Seed treatments for soybean and cotton

TO: Shaja Joyner, Risk Manager 20

Fungicide Branch

Registration Division (PRD) (7505P)

FROM: Geoffrey Sinclair, Ph.D., Biologist

Mohammed Ruhman, Ph.D., Senior Agronomist

Environmental Risk Branch V

Environmental Fate and Effects Division (7507P)

THROUGH: Mah Shamim, Ph.D., Branch Chief

Environmental Risk Branch VI

Environmental Fate and Effects Division (7507P)

This memo contains the findings of an ecological risk assessment for two new labels (Fluorpyram 

ST: EPA Reg. No 264-XXX that contains 48.4% a.i. or 5 lbs per gallon, and the amended label of 

Luna Privilege: EPA Reg. No. 264-1078 that contains 41.5% a.i. or 4.16 lbs per gallon) for four 

new uses: cotton seed treatment, in-furrow cotton application, soybean seed treatment, and peanut

applications. Fluorpyram is a fungicide and current formulations for fluopyram include suspension 

concentrates for the chemical alone (41.5% a.i), or with other fungicides including tebuconazole, 

trifloxystrobin, pyrimethanil, or prothioconazole. Fluopyram and /or its mixtures have agricultural 

uses on apples, watermelons, selected dry beans, grapes (wine), peanuts, potatoes, strawberries, 

sugerbeet, and tree nuts applied by ground, airblast, and aerial spray into foliage. The registrant is 

seeking registration of fluopyram for new uses as a fungicide to prevent and/or control fungal

diseases on cotton (as a seed treatment and in-furrow application during planting), soybeans (as 

seed treatment only) and Peanuts (in-furrow application during planting and as foliar spray). The 

biochemical mode of action of this chemical involves the inhibition of the enzyme succinate 

dehydrogenase within the fungal mitochondrial respiratory chain, thus blocking electron transport.
2

I. Previous Use Patterns and Ecological Risk Assessments

The ecological risk assessment that was previously conducted was an Environmental Fate and 

Ecological Risk Assessment for the Section 3 New Uses Registration of Fluopryram covering 

uses on almonds, apples, watermelons, selected dry beans, grapes (wine), peanuts, potatoes, 

strawberries, sugar beet, and tree nuts (DP Barcode: D353315, 369756, and 385637 dated 

8/29/11). Current formulations for fluopyram include suspension concentrates for the chemical 

alone (41.5% a.i), or with other fungicides including: tebuconazole (17.6% with 17.6% 

fluopyram), trifloxystrobin (21.4% with 21.4% fluopyram), pyrimethanil (33.8% with 11.3% 

fluopyram), or prothioconazole (17.4% with 17.4% fluopyram). Fluopryam has a maximum 

single application rate of 0.222 lb a.i./A and a maximum seasonal application rate of 0.444 lb a.i. 

/ A. 

The results of this screening-level risk assessment suggest the potential for chronic risk to nontarget mammals, birds, reptiles and terrestrial-phase amphibians based on modeled exposure 

resulting from spray applications of fluopyram. RQs for acute exposure were not calculated in 

the previous risk assessment due to non-definitive endpoints that were higher than the highest 

concentrations tested. Because of this, the author of previous assessment presumed low acute 

risk concerns (at levels below the levels of concern) exist for mammals, birds, reptiles and 

terrestrial-phase amphibians. An addendum was submitted to the Environmental Fate and 

Ecological Risk Assessment for Fluopyram Registration to correct the endpoints and risk 

quotients reported for the mammalian toxicity studies (DP Barcode: 396805). The corrected 

calculations still indicate chronic risk concerns using dose-based RQs, although a noticeable shift 

in magnitude occurs. All dietary-based RQs are below the level-of-concern.

Fluopyram shows low acute toxicity to terrestrial invertebrates on the basis of acute oral and 

contact studies on bees. Some reproductive effects to soil dwelling invertebrates were observed 

at high levels of fluopyram exposure (5.8 mg/L). Overall risk to terrestrial plant species is below 

the level of concern but some uncertainty exists with the effects of fluopyram on the seedling 

emergence of one dicot species, buckwheat due a non-definitive endpoint lower than the limit 

test concentration. In response to this uncertainty, a new study on this dicot species was since 

submitted (MRID 48934301) and results are reviewed in the current new use registration within 

this document. The use of the fluopyram at proposed label rates presents low risk to all aquatic 

taxa, including freshwater fish and aquatic invertebrates, estuarine/marine fish and aquatic 

invertebrates, aquatic-phase amphibians, freshwater and estuarine/marine benthic invertebrates 

and aquatic vascular and non-vascular plants. Acute RQs were not calculated due to nondefinitive endpoints higher than the highest concentrations tested but risk was presumed to be 

lower than the levels of concern for both listed and non-listed species.

II. Proposed New Use Patterns

Four new use patterns are included in this assessment associated with two labels (Table 1). The

first proposed new label Fluopyram ST (EPA Reg. No. 264-XXX) is applied as a seed treatment 

for cotton and soybeans. The maximum application rates for cotton seed treatments are 0.066 lbs 

a.i./A. This equates to 0.35 mg a.i./seed or 1.97 fl oz per 100,000 seeds. The maximum 

application rates for soybeans seed treatments are 0.138 lbs a.i./A. This equates to 0.25 mg 
3

a.i./seed or 1.97 fl oz per 140,000 seeds. The seed treatments stipulate the following restriction: 

do not apply more than 0.45 lb of fluorpyram per acre per year including seed treatment, soil, 

and foliar uses for this crop or other registered crops.

The second proposed new label is a label amendment of the LUNA PRIVILEGE product (EPA 

Reg. No. 264-1078) for an in-furrow application for both cotton and peanuts. The maximum 

single application rate is 0.222 lbs a.i./A and a maximum seasonal application rate is 0.222 lbs 

a.i./A for cotton. For peanuts, the maximum single application rate is 0.222 lbs a.i./A with a 

minimum 14 day interval and the maximum seasonal application rate is 0.445 lbs a.i./A. This 

label contains the following restrictions:

 Do not apply more than 13.7 fl of LUNA PRIVILEGE per acre per season

 Do not apply with aerial application equipment

 To limit disease resistance, do not make more than 2 sequential applications of LUNA 

PRIVILEGE or any Group 7-containing fungicide before rotating with a fungicide of a 

different group.

Table 1 Proposed New and amended use patterns for fluopyram

Crop Form 1 Maximum Rates (lbs a.i/A)

Minimum 

Intervals 

(days)

Application Method(s) and 

Timing

Cotton seed treatment 1 0.066 20.066 Not Applicable Seed Treatment at planting

Cotton 2 0.222 0.222 Not Applicable

In-Furrow application at 

planting

Cotton total 1 & 2 0.066 + 0.222 0.288 Not Applicable

Two separate applications at 

planting

Soybean seed treatment 1 0.138 30.138 Not Applicable Seed Treatment at planting

Peanuts 2 0.222 0.445 14

Assume Ground application 

at time of seeding (Infurrow) + another foliar 

application post- emergence 

(Ground, Air Or 

Chemigation)

1Form= Formulation: 1= Fluopyram ST: EPA Reg. No. 264-XXX (a.i Fluopyram alone); and 2= Luna® Privilege: 

EPA Reg. No. 264-1078 (a. I Fluopyram alone)

2 Calculations of the cotton seeds application rate/A is based on BEAD maximum seeding rate of 85,000 seeds/A: 

Application Rate= 0.07716 X (85,000/100,000)= 0.065586 lbs a.i /A

3 Calculations of soybean seeds application rate/A is based on BEAD maximum seeding rate of 250,000 seeds/A: 

Application Rate= 0.07716 X (250,000 140,00)= 0.137786 lb a.i /A

In consideration of the new labels it was necessary to execute new PRZM/EXAMS runs to 

represent the new crops of cotton (using scenarios CAcottonWirrigSTD and MScottonSTD); 

soybeans (using the scenario MSsoybeanSTD); and peanuts (using the scenario NCpeanutSTD). 

Additionally, Tier II Surface Water Concentration Calculator (Version 1.100) is to be used 

instead of PE-5 as per the recent EFED policy.
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III. Estimating Exposure EECs from Surface Water Sources

With few exceptions, the exact procedure/parameters used previously in the Ecological Risk 

Assessment (DP Barcode: 353315, 360756, 385637 dated August 29, 2011) were used in 

modeling the proposed new uses (US EPA 2011). The exceptions include the use of appropriate 

application parameters (Table 1), scenarios, and the following inputs:

a. Cotton: the 1st application is with seeds at a depth of 1.27 cm and the 2nd

application is in-furrow by ground equipment (0.062 drift) incorporated at the 

same depth of 1.27 cm;

b. Soybeans: Only one application (no other registration for this crop) with seeds at 

a depth of 1.91 cm.

c. Peanuts: The 1st application is in-furrow by ground equipment (0.062 drift) 

incorporated at a depth of 3.81 cm and the 2nd application is foliar by air (0.125 

drift).

Tier II Surface Water Concentration Calculator (Version 1.100) using PRZM5 and VVWM) was 

used for modeling. The results for the new uses are summarized in Table 2, below. 

Table 2 A summary of surface water EECs (in ppb) for the proposed new uses of fluopyram

Crop: Scenario Acute (Peak) 21-day 60-day

Cotton: MScotton 11.0 10.8 10.6

Cotton: CAcotton 3.39 3.29 3.17

Soybeans: MSsoybeans 0.38 0.36 0.35

Peanuts: NCpeanuts 14.3 14.1 13.8
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IV. Effects Summary

Table 3 shows the acute and chronic effects data that were used for estimating risk to aquatic 

animals and plants. 

Table 3. Toxicity reference values for aquatic organisms exposed to fluopyram

technical or formulated fluopyram (Fluopyram SC 500A, 41.5% active 

ingredient).

Exposure 

Scenario

% Active 

Ingredient Species Exposure Duration

Toxicity 

Reference 

Value

Reference

Classification

Freshwater Fish

Acute

TGAI Rainbow Trout

96 hours

LC50>1.78 mg 

a.i./L MRID 47372328

94.70% Oncorhynchus 

mykiss

NOAEC=1.78 

mg a.i./L Acceptable

TEP Rainbow Trout

96 hours

LC50 >46.4 

mg a.i./Lb MRID 47372333

41.50% Oncorhynchus 

mykiss

NOAEC=1.31 

mg a.i./L Supplemental

Chronic

TGAI

Fathead minnow 

Pimephales 

promelas

33 days

NOAEC = 

0.135 mg 

a.i./L

MRID 47372336

94.70%

LOAEC = 

0.269 mg 

a.i./L

Acceptable

Freshwater Invertebrates

Acute

TGAI Water flea

48 hours

EC50>17 mg 

a.i./L MRID 47372324

94.70% Daphnia magna NOAEC=17 

mg a.i./L Acceptable

TEP Water flea

48 hours

EC50>38.2 mg 

a.i./L MRID 47372325

41.50% Daphnia magna NOAEC=11.6 

mg a.i./L Acceptable

Chronic

TGAI Water flea

21 days

NOAEC = 

1214 μg a.i./L MRID 47372334

94.70% Daphnia magna LOAEC = 

2996 μg a.i./L Acceptable

Estuarine/Marine Fish

Acute

TGAI Sheepshead 

minnow

96 hours

LC50 >0.98 

mg a.i./La MRID 47372330

94.70% Cyprinodon 

variegatus

NOAEC=0.98 

mg a.i./L Acceptable

Chronic No Data
6

Estuarine/Marine Invertebrates

Acute

TGAI Saltwater mysid 

Americamysis 

bahia

96 hours

EC50>0.51 mg 

a.i./L MRID 47372327

94.70% NOAEC=0.27 

mg a.i./L Acceptable

Chronic No Data

Freshwater Benthic Invertebrates

Acute No Data

Chronic

TGAI Midge 

54 days

Sediment 

concentrations MRID 47372339

94.70% Chironomus tentans

NOAEC = 26 

mg a.i./kg 

sediment

Supplemental

LOAEC = 48 

mg a.i./kg 

sediment

Pore water 

concentrations

NOAEC = 3.8 

mg a.i./L pore 

water

LOAEC = 8.8 

mg a.i./L pore 

water

Estuarine/Marine Benthic Invertebrates

Acute

TGAI Saltwater amphipod

10 days

Sediment 

value: MRID 47372338

94.70% Leptocheirus 

plumulosus

LC50 > 100 

mg a.i./kg 

sediment

Acceptable

NOAEC=100 

mg a.i./kg 

sediment

Pore water 

value:

LC50 > 7.5 mg 

a.i./L pore 

water

NOAEC = 7.5 

mg a.i./L pore 

water
7

Chronic

TGAI Saltwater amphipod

28 days

Sediment 

concentrations MRID 47372335

94.70% Leptocheirus 

plumulosus

NOAEC = 36 

mg TRR/kg 

sediment

Supplemental

LOAEC = 92 

mg TRR/kg 

sediment

Pore water 

concentrations

NOAEC = 2.5 

mg TRR/L 

pore water

LOAEC = 5.9 

mg TRR/L 

pore water

Aquatic Plants

TGAI

Pseudokirchneriella 

subcapitata 96 hours

EC50 = 4.3 mg 

a.i./L MRID 47372403

94.70% NOAEC = 

1.46 mg a.i./L Acceptable

(biomass)

TEP

Pseudokirchneriella 

subcapitata 72 hours

EC50 = 3.4 mg 

a.i./L MRID 47372407

41.50% NOAEC = 

1.17 mg a.i./L Acceptable

(cell density)

Fluopyramlactame 

(metabolite)

Pseudokirchneriella 

subcapitata 72 hours

EC50 >8.87 

mg a.i./L MRID 47372418

94% NOAEC = 

8.87 mg a.i./L Acceptable

(for both cell 

density and 

growth rate)

Macrophyte TGAI Duckweed

7 days

EC50 = 2.6 mg 

a.i./L MRID 47372401

94.70% Lemna gibba NOAEC = 

0.28 mg a.i./L Acceptable
8

(frond number 

based on 

yield)

TEP Duckweed

7 days

EC50 = 2.9 mg 

a.i./L MRID 47372402

41.60% Lemna gibba NOAEC = 

1.04 mg a.i./L Acceptable

(frond number 

based on 

yield)

a These values were used for evaluation of risk via spray drift only.

Table 4 shows the acute and chronic effects data that were used for estimating risk to terrestrial 

animals and plants. 

Table 4. Toxicity reference values for terrestrial organisms exposed to 

fluopyram technical or formulated fluopyram (Fluopyram SC 500A, 41.5% 

active ingredient). 

Exposure 

Scenario

% Active 

Ingredient Species Exposure Duration

Toxicity 

Reference Reference

Value

Mammals

Acute

TGAI Laboratory 

Rat 

Single oral 

dose 

LD50 > 2000 

mg a.i./kg 

bw

MRID

(94.7% a.i.) (Rattus 

norvegicus) 47372430

Acceptable

Chronic 

TGAI

Laboratory 

Rat (Rattus 

norvegicus)

90-day 

dietary 

study

NOAEL = 

13 mg a.i./kg 

bw/day 

MRID 

47372441

(94.7% a.i.)

LOAEL = 61 

mg a.i./kg 

bw/day

Acceptable

Birds

Acute

TGAI

Northern 

bobwhite quail 

(Colinus 

virginianus) 

and zebra 

Single oral 

dose 

LD50 >2000 

mg a.i./kg 

bw

MRIDs 

47372341 

(94.5% a.i. 

[bobwhite] and Acceptable
9

94.7% a.i 

[zebra finch]).

finch 

(Taeniopygia 

guttata)

and 

47567007

Supplemental

Acute

TGAI

Northern 

bobwhite quail 

(Colinus 

virginianus)

5-Day 

dietary 

LC50 >4785 

mg a.i./kg 

diet

MRID 

47372343

(95.0% a.i.)

Acceptable 

Chronic

TGAI Bobwhite 

quail

Avian 

reproduction 

study 

(dietary 

exposure, 

one 

generation) 

NOAEC = 

46.7 mg 

a.i./kg dieta

MRIDs 

47372344

(94.7% a.i.)

(Colinus 

Virginianus) 

and Mallard 

duck (Anas 

platyrhynchos)

Acceptable

LOAEC = 

75.7 mg 

a.i./kg dieta

47372345

Supplemental

47372346

Acceptable

Terrestrial Insects

Acute

TGAI Honey bee

96-Hour 

acute 

contact and 

oral toxicity 

test 

Contact 

toxicity

MRID 

47372347

(95.5% a.i.) (Apis 

mellifera)

LD50 >100 

μg test 

material/bee

Contact 

toxicity test:

Acceptable

Oral toxicity

LC50 >102.3 

μg test 

material/bee
10

Acute

TEP Honey bee

96-Hour 

acute 

contact and 

oral toxicity 

test 

Contact 

toxicity

MRID 

47372348

(41.6% a.i.) (Apis 

mellifera)

LD50 > 83.2 

μg a.i./bee

Contact 

toxicity test:

Oral toxicity Acceptable

LC50 > 89 μg 

a.i./bee

Plants - Tier I seedling emergence

Monocot

TEP Oat (Avena 

sativa), perennial 

ryegrass (Lolium 

perenne), barley

(Hordeum vulgare) 

and corn (Zea 

mays)

Single 

application 

at test 

initiation

EC25 >0.444 

lbs a.i./A

MRID 

47372349

(41% a.i.)

NOAEC = 

0.444 lbs 

a.i./A

Acceptable

Dicot

TEP

Sugarbeet (Beta 

vulgaris), oilseed 

rape (Brassica 

napus), soybean 

(Glycine max), 

cucumber 

(Cucumis sativus), 

buckwheat 

(Fagopyrum 

esculentum) and 

sunflower 

(Helianthus 

annuus)

Single 

application 

at test 

initiation

EC25 <0.444 

lbs a.i./A

MRID 

47372349

(41% a.i.)

NOAEC 

<0.444 lbs 

a.i./A

Acceptable

Plants - Tier II seedling emergence

Dicot

TEP Buckwheat

Full test

EC25 <0.444 

lbs a.i./A

MRID* 

48934301

(42% a.i.) (Fagopyrum 

esculentum)

NOAEC 

0.444 lbs 

a.i./A

Supplemental

Plants - Tier I vegetative vigor

Monocot

TEP

Onion (Allium 

cepa), oat

(Avena 

sativa), 

perennial 

ryegrass

(Lolium 

perenne) and 

Single 

application 

at test 

initiation

EC25 >0.222 

lbs a.i./A

MRID 

47372350

(41% a.i.)

NOAEC = 

0.222 lbs 

a.i./A
11

corn (Zea 

mays)

Acceptable

Dicot

TEP

sugarbeet 

(Beta 

vulgaris), 

oilseed rape

(Brassica 

napus), 

cucumber

(Cucumis 

sativus), 

buckwheat 

(Fagopyrum 

esculentum), 

soybean 

(Glycine max) 

and sunflower

(Helianthus 

annuus)

Single 

application 

at test 

initiation

EC25 >0.222 

lbs a.i./A MRID 

(41% a.i.)

NOAEC = 

0.222 lbs 

a.i./A

47372350

Acceptable

*Bolded MRID indicates newly submitted study for this assessment.

In response to a supplemental study examining seedling emergence on the dicot buckwheat, an 

additional seedling emergence study was submitted (MRID 48934301). This study was 

scientifically sound but because this study only examined the dicot buckwheat it is considered 

supplemental. It does however fulfill the guideline requirements when combined with the 

previously submitted seedling emergence study (MRID 47372349). At the application rates of 

0.444 lb a.i. /A buckwheat had inhibitions in emergence and survival of up to 5.4%; however 

there was also a slight promotion shoot length and overall no general trend was observed. The 

maximum nhibition in dry weight was 1.9%, but was observed with promotion of dry weight as 

well. There was no effect in the negative control or any treatment group and the NOAEC was 

established as 0.444 lb a.i. / A.

V. Risk Estimation

A. Risk Estimation for Aquatic Animals

Risks to aquatic animals from the proposed use of fluopryam are summarized in Table 5. For 

aquatic animals, no acute or chronic risks were identified either for listed or non-listed species. 

No chronic toxicity data are available for estuarine/marine invertebrates or fish. When possible 

the Agency uses the acute to chronic ratio (ACR) to bridge missing toxicity data in establishing 

potential risk to taxa with missing data. In this case establishing an ACR was not possible due to 

non-definitive endpoints in the taxa where data did exist. Given the EECs that were generated 

from the new proposed uses, it is reasonable to expect that aquatic animals are at low risk from 

the proposed uses which is similar to the established uses covered in the previous assessment on 
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fluopyram (US EPA 2011).

Table 5. Aquatic Animal RQ Values for Exposure to Fluopyram.

Taxa

Acute 

EEC 

Chronic 

EEC

Acute 

EC/LC50

Chronic 

NOAEC Acute 

RQ

Chronic 

(ug RQ

a.i./L)

(ug 

a.i./L)

(ug 

a.i./L)

(ug 

a.i./L)

Cotton: MS cotton

Freshwater Fish 11 10.6 >1780 135 <0.01 0.08

Freshwater 

Invertebrates 11 10.8 >17000 1,240 <0.01 0.09

Estuarine / 

Marine Fish 11 10.6 >980 - <0.01 -

Estuarine / 

Marine 

Invertebrates

11 10.8 >510 - <0.02 -

Cotton: CA cotton

Freshwater Fish 3.39 3.17 >1780 135 <0.01 0.02

Freshwater 

Invertebrates 3.39 3.29 >17000 1,240 <0.01 <0.01

Estuarine / 

Marine Fish 3.39 3.17 >980 - <0.01 -

Estuarine / 

Marine 

Invertebrates

3.39 3.29 >510 - <0.01 -

Soybeans: MS soybeans

Freshwater Fish 0.38 0.35 >1780 135 <0.01 <0.01

Freshwater 

Invertebrates 0.38 0.36 >17000 1,240 <0.01 <0.01

Estuarine / 

Marine Fish 0.38 0.35 >980 - <0.01 -

Estuarine / 

Marine 

Invertebrates

0.38 0.36 >510 - <0.01 -

Peanuts: NC peanuts

Freshwater Fish 14.3 13.8 >1780 135 <0.01 0.1

Freshwater 

Invertebrates 14.3 14.1 >17000 1,240 <0.01 0.01

Estuarine / 

Marine Fish 14.3 13.8 >980 - 0.01 -

Estuarine / 

Marine 

Invertebrates

14.3 14.1 >510 - 0.03 -
13

B. Risk Estimation for Aquatic Plants

Risks to aquatic plants from the proposed use of fluopyram on cotton, soybeans and peanuts are 

summarized in Table 6. There were not any risks identified for either listed or non-listed species

of aquatic nonvascular and vascular plants. RQ values ranged from < 0.01 to 0.05, which is 

consistent with the low risk determinations in previous assessments. 

Table 6. Acute RQs for non-vascular and vascular aquatic plants exposed to fluopyram. 

EC50

NOAEC 

or EC05

Peak 

Water 

Column 

EEC (μg 

a.i./L)

RQ RQs

Plant Type (μg 

a.i./L)

(μg 

a.i./L)

endangered 

species

other nontarget plants

(Peak 

EEC/EC50) 

c

(Peak 

EEC/NOAEC 

or EC05) d

Cotton: MS cotton

Non-vascular 

plants a 3400 1170 11 0.01 <0.01

Vascular plants b 2600 278 11 0.04 <0.01

Cotton: CA cotton

Non-vascular 

plants a 3400 1170 3.39 <0.01 <0.01

Vascular plants b 2600 278 3.39 0.01 <0.01

Soybeans: MS soybeans

Non-vascular 

plants a 3400 1170 0.38 <0.01 <0.01

Vascular plants b 2600 278 0.38 <0.01 <0.01

Peanuts: NC peanuts

Non-vascular 

plants a 3400 1170 14.3 0.01 <0.01

Vascular plants b 2600 278 14.3 0.05 0.01

a For freshwater green algae (Pseudokirchneriella subcapitata) the EC50 = 3.4 mg a.i./L and 

NOAEC = 1.17 mg a.i./L based on a study with the formulated fluopyram product (41.5% 

active ingredient). The most sensitive endpoint was cell density.

b For duckweed (Lemna gibba), the EC50 = 2.6 mg a.i./L and NOAEC = 0.278 mg a.i./L 

based on a study with fluopyram technical. The most sensitive endpoint was frond number 

based on yield.

c Endangered species LOC > 0.05

d Acute toxicity LOC > 0.5

C. Risk Estimation for Terrestrial Animals

Risks to terrestrial animals were assessed for four proposed new uses. Two new uses were for 

seed treatments to soybeans and cotton. One new use was an in-furrow application to cotton, and 
14

one new use was a consecutive in-furrow application to peanuts followed by a foliar application. 

a) Seed treatments on soybeans and cotton

Calculation of risk quotients from seed treatments require conversion of the application rates 

listed on labels to units required for the T-REX model. Both the conversions and an example TREX run are presented in Appendix 1. 

Risks to both avian and mammalian taxa from seed treatments for both soybeans and cotton are 

presented in Table 7. For soybeans, the seed treatment resulted in an acute risk to listed avian 

species as well as chronic risk to both listed and non-listed species of birds and mammals in all 

weight classes. An RQ of 0.14 in the avian 20 g category exceeded the LOC of 0.1 indicating 

listed species in this weight class may be adversely affected by acute exposures. Avian chronic 

RQs were 17.65 and exceeded the LOC of 1.0 for chronic exposure. Mammalian chronic RQs 

ranged from 2.8 to 6.11, all exceeding the chronic LOC of 1.0, indicating potential chronic 

adverse effects when exposed to fluopyram through soybean seed treatments. There was not any 

mammalian acute risk identified for any mammalian weight class exposed to soybean seed 

treatments.

For the cotton seed treatment there was potential risk to avian taxa identified on both an acute 

and chronic basis. The avian weight class of 20g had an RQ of 0.61 and exceeded the LOC of 

0.5 suggesting potential adverse effects to both listed and non-listed avian species in this weight 

class. The avian weight class of 100 g had a RQ of 0.27 which exceeded the LOCs for acute 

restricted use (LOC = 0.2) and listed species (LOC= 0.1). This suggests that listed species may 

potentially be adversely affected and risks may be mitigated through restricted use patterns. 

Chronic risk was identified in all avian weight classes with an RQ of 74.11 in each category 

greatly exceeding the chronic LOC of 1.0.

The mammalian weight classes of 15g and 35g had RQs of 0.17 and 0.14 respectively. These 

both exceed the LOC for listed species (0.1) and indicate potential adverse effects to listed 

species on an acute exposure basis when exposed to cotton seed treatments. Chronic mammalian 

RQs ranged from 11.75 to 25.66 and all significantly exceeded the chronic LOC of 1.0 indicating 

risk to both listed and non-listed species.

Table 7. Risk quotients for terrestrial animals as a result of seed treatments on soybean and 

cotton.

Risk Quotients†

Soybean

Acute (# 1) Acute (# 2) Chronic

Avian (20 g) 0.14 0.01 17.65

Avian (100 g) 0.06 0.00 17.65

Avian (1000 g) 0.02 0.00 17.65

Mammalian (15 g) 0.04 0.00 6.11

Mammalian (35 g) 0.03 0.00 5.22
15

Mammalian (1000 g) 0.02 0.00 2.80

Cotton

Acute (# 1) Acute (# 2) Chronic

Avian (20 g) 0.61 0.02 74.11

Avian (100 g) 0.27 0.00 74.11

Avian (1000 g) 0.09 0.00 74.11

Mammalian (15 g) 0.17 0.01 25.66

Mammalian (35 g) 0.14 0.01 21.92

Mammalian (1000 g) 0.08 0.00 11.75

Acute RQ #1 = (mg ai /kg-bw/day) / LD50

Acute RQ #2 = mg ai ft-2 /(LD50*bw)

Avian Chronic RQ =mg kg-1 seed / NOAEL

Mammalian Chronic RQ = mg a.i./kg-bw/day / adjusted NOAEL

b) In-furrow applications on cotton

An example of the T-REX model run for the in-furrow application of fluopyram is provided in 

Appendix 2. While the in-furrow application represents a new application pattern it is modeled 

in much the same way as a ground application. As a consequence of this similarity the risk 

picture is similar to those modeled in previous risk assessments but are presented here to capture 

the additional application method. 

There were not any acute risks to either birds or mammals associated with the in furrow 

application of fluopyram on cotton. RQs ranged from <0.01 to 0.04 for birds and were 0.01 or 

less for mammals. Chronic risk was determined for birds on a dietary basis feeding on short 

grass (Table 8). Dose-based chronic risk was identified in mammals feeding on short grass and 

broadleaf plants. Small mammals (in the 15 g weight class) had RQs of 1.78 and 1.0 for short 

grass and broad leaf plants respectively. The RQ for mammals in the 35 g weight class was 1.52 

for short grass (Table 9.) There was not any chronic risk to mammals on a dietary basis.

Table 8. Dietary-based chronic RQs for birds exposed to fluopyram based 

on upper-bound residues on short grass, tall grass, broadleaf plants/small 

insects, and fruits/pods/seeds/large insects as calculated by T-REX

Avian Dietary Risk Quotients*

Short 

Grass

Tall 

Grass

Broadleaf 

Plants/ Fruits/Pods/seeds Arthropods

Chronic 

RQs 1.14 0.52 0.64 0.07 0.45

These values were calculated using the maximum application rate (0.222 lb 

a.i./A), the maximum number of applications (1), and a chronic NOAEC = 46.70 

mg a.i./kg diet in bobwhite quail and a default chemical foliar half-life of 35 

days.
16

Table 9. Dose-based chronic RQs for small (15g), intermediate (35g), and large 

(1,000g) mammals exposed to fluopyram based on upper-bound residues on 

short grass, tall grass, broadleaf plants/small insects, fruits/pods/large insects 

and seeds as calculated by T-REX 

Mammalian Chronic Risk Quotient*

Body 

Weight 

(g)

Short 

Grass

Tall 

Grass

Broadleaf 

Plants/ Fruits/Pods Arthropods

Seeds

15 1.78 0.81 1.00 0.11 0.70 0.02

35 1.52 0.70 0.85 0.09 0.59 0.02

1000 0.81 0.37 0.46 0.05 0.32 0.01

* These values were calculated using the maximum application rate (0.222 lb a.i./A), 

the maximum number of applications (2), the minimum application interval (14 

days), and an estimated chronic NOAEL = 0.75 mg a.i./kg body weight/day in rats 

based on the chronic dietary NOAEC = 13 mg ai/kg diet and a default chemical foliar 

half-life of 35 days.

c) Peanut applications

There were not any acute risks, either dose-based or dietary, to either birds or mammals 

associated with the in furrow application of fluopyram on peanuts followed by a foliar 

application with the minimum 14 day interval (Table 1). Dietary-based RQs for both short grass 

and broadleaf plants (RQ = 2.01 and 1.13 respectively) indicated chronic risk to avian taxa under 

the given the proposed uses for peanuts (Table 10). Dosed-based chronic risk to mammals was 

identified for short grass, tall grass, broadleaf plants and arthropods. The RQs for short grass 

exceeded the LOC of 1.0 for all mammalian weight classes with RQs ranging from 3.13 and 1.43

while only the 15 g and 35 g weight classes exceeded the LOC of 1.0 for tall grass, broadleaf 

plants, and arthropods (Table 11). There was not any dietary based chronic risk identified for 

mammals for in-furrow plus foliar use of fluopyram on peanuts. 

Table 10. Dietary-based RQs for birds exposed to fluopyram based on upperbound residues on short grass, tall grass, broadleaf plants/small insects, and 

fruits/pods/seeds/large insects as calculated by T-REX

Avian Dietary Risk Quotients*

Short 

Grass

Tall 

Grass

Broadleaf 

Plants/ Fruits/Pods/seeds Arthropods

Chronic 

RQs 2.01 0.92 1.13 0.13 0.79

a These values were calculated using the maximum application rate (0.222 lb 

a.i./A), the maximum number of applications (2), the minimum application interval 

(14 days), and a chronic NOAEC = 46.70 mg a.i./kg diet in bobwhite quail and a 

default chemical foliar half-life of 35 days.
17

Table 11. Dose-based chronic RQs for small (15g), intermediate (35g), and large 

(1,000g) mammals exposed to fluopyram based on upper-bound residues on 

short grass, tall grass, broadleaf plants/small insects, fruits/pods/large insects 

and seeds as calculated by T-REX 

Mammalian Chronic Risk Quotient*

Body 

Weight 

(g)

Short 

Grass

Tall 

Grass

Broadleaf 

Plants

Fruits / 

Pods Arthropods

Seeds

15 3.13 1.43 1.76 0.20 1.22 0.04

35 2.67 1.22 1.50 0.17 1.05 0.04

1000 1.43 0.66 0.80 0.09 0.56 0.02

* These values were calculated using the maximum application rate (0.222 lb a.i./A), 

the maximum number of applications (2), the minimum application interval (14 

days), and an estimated chronic NOAEL = 0.75 mg a.i./kg body weight/day in rats 

based on the chronic dietary NOAEC = 13 mg ai/kg diet and a default chemical foliar 

half-life of 35 days.

D. Risk Estimation for Terrestrial Plants

As reviewed in the previous assessment, in the vegetative vigor study, sugarbeet had the highest 

level of inhibition in dry weight, a 20.2% reduction in comparison to the negative control at a 

fluopyram application rate of 0.222 lbs a.i./A. The rate applied in the Tier I seedling emergence 

test, 0.444 lbs a.i./A, was greater than the maximum application rate of 0.222 lbs a.i./A. The 

original buckwheat study submitted for the previous risk assessment showed a 50.4% reduction in 

dry weight at 0.444 lbs a.i./A in the seedling emergence test (MRID 47372349; US EPA 2011). A 

more recent Tier II study submitted for this assessement (MRID 48934301) demonstrated that 

there were not any observable effects at the maximum application rates of 0.44 lb a.i./A. The 

NOAEC for this study was 0.4440 lb a.i./A.

A preliminary run of TERR-PLANT was conducted using the maximum application scenarios 

for ground application (both labeled use rates for the combined cotton applications of 0.288 lb 

a.i./A and the application for peanuts of 0.222 lb a.i./A) listed in Table 1. All EECs ranged from 

0.002 (spray drift) to 0.0576 (semi-aquatic areas) lbs a.i./A for ground application for the cotton 

application and from 0.002 (spray drift) to 0.04 (semi-aquatic areas) lbs a.i./A for ground 

application on peanuts. The latter application of 0.222 lb a.i./A was the same as those assessed 

in the previous risk assessment on fluopyram (US EPA 2011). In all scenarios used in this 

assessment, there was not any risk identified to either listed or non-listed monocots and dicots in 

dry and semi-aquatic areas as a result of runoff or spray drift. For the in-furrow peanut scenario 

with application rates of 0.222 lb a.i./A RQs did not exceed the LOC of 1.0 that would indicate 

risk and ranged from <0.01 in dry are areas and in areas exposed to spray drift, to 0.11 in semiaquatic areas. For the cotton scenario with combined application rates of 0.288 lb a.i./A RQs 
18

did not exceed the LOC of 1.0 that would indicate risk and ranged from <0.01 in dry are areas 

and in areas exposed to spray drift, to 0.14 in semi-aquatic areas.

VI. Risk Summary 

The RQs are summarized in the above tables. Risk associated with the proposed new uses of 

fluopyram are confined primarily to terrestrial taxa. Acute risk was indicated from both seed 

treatments with soybeans potentially adversely affecting listed small avian taxa (20g weight 

class) on acute basis and cotton seed treatments potentially adversely affecting both small and 

medium listed avian and mammalian taxa (20 g and 100 g for birds and 15 and 35g for 

mammals) on an acute basis. There was chronic risk indicated for both avian and mammalian tax 

from all four of the proposed new uses.

Citations:

US. EPA 2011. Environmental Fate and Ecological Risk Assessment for Fluopyram

Registration (PC Code 080302; DP Barcodes 353315, 369756, and 385637)
19

VII. Appendix 1: Calculation of the Seed Treatment Applciation 

rates and an Example T-Rex Run for Cotton Seed-Treatment

The application rate for cotton was provided on the label as 0.35 mg ai/seed. This equates to 

1.97 fl oz / 100,000 seeds as is also indicated on the label. According to the Biological and 

Economic Analysis Division (BEAD) in the Office of Pesticide Programs, 1 lb of cotton seeds 

averages 4500 cotton seeds. A hundred count of seeds (cwt) then equates to 450,000 seeds. The 

application rate in fl oz/cwt used in the seed treatment analysis is then calculated as 450,000 X 

1.97)/100,000. Below is the TREX seed treatment runs using the calculations for cotton. This 

was also calculated and run using soybean seed treatments which are not presented below. 

According to BEAD, 1500 seeds make up a pound and therefore 100 lbs of soybean seeds equate 

to 150000. The label states an application rate of 0.25 mg a.i./seed or 1.97 fl oz/140,000 seeds. 

The application rate of the soybean seed treatment comes out to 2.1 fl oz / cwt. 

Chemical Name: Fluopyram ST Application Rate (lb ai/acre)

Seed Treatment? 

(Check if yes)

TRUE Seeding Rate 

(lbs/acre)

 Use: 5 18.9

Product name and 

form: Fluopyram ST

% A.I. (leading zero 

must be entered for 

formulations <1% a.i.): 100.00%

Application rate (fl 

oz/cwt) 8.87

Half-life (days): 35

Application Interval 

(days): 0

Number of 

Applications: 1

Are you assessing 

applications with 

variable rates or 

intervals? no

Chemical: Fluopyram ST

Name of seed treatment formulation: Fluopyram ST

Percent AI in formulation: 

100

Density of product 

(lbs/gal): 5

Endpoints

Reporte

d

Tested 

Body Adjusted LD50

Size class for adjusted 

LD50

Weight (g)

Avian LD50: 2000 178 1440.859037 Small (20g)
20

Avian repro. 

NOAEC: 46.7 1834.285763

Medium 

(100g)

2590.997508

Large 

(1000g)

Mammalian 

LD50: 2000 350 4395.661004 Small (15g)

Mammalian 

NOAEL: 260 3556.55882

Medium 

(35g)

1538.321135

Large 

(1000g)

Adjusted NOAEL for Mammals

Small 

(15g) 28.57179653

Medium 

(35g) 23.11763233

Large 

(1000g) 9.999087375

Animal 

Size Crop

Maximum 

Application 

Rate

Maximum 

Seed 

Application 

Rate

Avian 

Nagy 

Dose

Mammalian 

Nagy Dose Available AI

(lbs ai/A)

(mg ai/kg 

seed)

(mg 

ai/kgbw/day)(mg ai/kgbw/day) (mg ai ft-2)

Small

cotton, all 

or 

unspecified 0.06537326 3460.9375 875.9247 733.275304 0.682165288

Medium 499.4894 506.791334

Large 223.628 117.501348

Crop Risk Quotients†

Avian (20 g) Mammalian (15 g)

Acute (# 1)

Acute (# 

2) Chronic

Acute (# 

1)

Acute (# 

2) Chronic

cotton, all 

or 

unspecified 0.61 0.02 74.11 0.17 0.01 25.66

Avian (100 g) Mammalian (35 g)

Acute (# 1)

Acute (# 

2) Chronic

Acute (# 

1)

Acute (# 

2) Chronic
21

cotton, all 

or 

unspecified 0.27 0.00 74.11 0.14 0.01 21.92

Avian (1000 g) Mammalian (1000 g)

Acute (# 1)

Acute (# 

2) Chronic

Acute (# 

1)

Acute (# 

2) Chronic

cotton, all 

or 

unspecified 0.09 0.00 74.11 0.08 0.00 11.75

† Acute RQ #1 = (mg ai /kg-bw/day) / LD50

Acute RQ #2 =

mg ai ft-2 

/(LD50*bw)

Avian Chronic RQ =

mg kg-1 seed / 

NOAEL

Mammalian Chronic 

RQ = mg a.i./kg-bw/day / adjusted NOAEL

Animal

Nagy allometry

Food ingestion value g/day

20 g Bird 5.061777181

15 g Mammal 3.178078065

100 g Bird 14.4321986

35 g Mammal 5.125113265

1000 g Bird 64.6148732

1000 g Mammal 33.95072796
22

VIII. Appendix 2: T-REX Example Run for In-Furrow Application in 

Peanuts

Chemical Name: Fluopyram ST

 Use 0

 Formulation Fluopyram ST

Application Rate 0.222 lbs a.i./acre

Half-life 35 days 

Application Interval 14 days

Maximum # Apps./Year 2

Length of Simulation 1 year

Variable application rates? no

Endpoints

Avian

Bobwhite quail LD50 (mg/kg-bw) 2000.00

Mallard duck) LC50 (mg/kg-diet) 4604.00

Bobwhite quail NOAEL(mg/kg-bw) 0.00

Bobwhite quail NOAEC (mg/kg-diet) 46.70

Mammals

LD50 (mg/kg-bw) 2000.00

LC50 (mg/kg-diet) 0.00

NOAEL (mg/kg-bw) 13.00

NOAEC (mg/kg-diet) 260.00

Dietary-based EECs 

(ppm)

Kenaga

Values

Short Grass 93.66

Tall Grass 42.93

Broadleaf plants 52.68

Fruits/pods/seeds 5.85

Arthropods 36.68
23

Avian Body 

Ingestion 

(Fdry)

Ingestion 

(Fwet) % body wgt FI

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

Small 20 5 23 114 2.28E-02

Mid 100 13 65 65 6.49E-02

Large 1000 58 291 29 2.91E-01

20 5 5 25 5.06E-03

Granivores 100 13 14 14 1.44E-02

1000 58 65 6 6.46E-02

Avian Body Adjusted LD50

Weight (g) (mg/kg-bw)

20 1440.86

100 1834.29

1000 2591.00

Dose-based EECs 

(mg/kg-bw)

Avian Classes and Body Weights (grams)

small mid large

20 100 1000

Short Grass 106.67 60.83 27.23

Tall Grass 48.89 27.88 12.48

Broadleaf plants 60.00 34.21 15.32

Fruits/pods 6.67 3.80 1.70

Arthropods 41.78 23.82 10.67

Seeds 1.48 0.84 0.38

Dose-based RQs 

(Dose-based EEC/adjusted LD50)

Avian Acute RQs

Size Class (grams)

20 100 1000

Short Grass 0.07 0.03 0.01

Tall Grass 0.03 0.02 0.00

Broadleaf plants 0.04 0.02 0.01

Fruits/pods 0.00 0.00 0.00

Arthropods 0.03 0.01 0.00

Seeds 0.00 0.00 0.00

Dietary-based RQs 

(Dietary-based EEC/LC50 or 

NOAEC)

RQs

Acute Chronic

Short Grass 0.02 2.01

Tall Grass 0.01 0.92

Broadleaf plants 0.01 1.13
24

Fruits/pods/seeds 0.00 0.13

Arthropods 0.01 0.79

Mammalian Results

Mammalian Body 

Ingestion 

(Fdry)

Ingestion 

(Fwet) % body wgt FI

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

15 3 14 95 1.43E-02

Herbivores/ 35 5 23 66 2.31E-02

insectivores 1000 31 153 15 1.53E-01

15 3 3 21 3.18E-03

Grainvores 35 5 5 15 5.13E-03

1000 31 34 3 3.40E-02

Mammalian Body Adjusted Adjusted

Class Weight LD50 NOAEL

15 4395.66 28.57

Herbivores/ 35 3556.56 23.12

insectivores 1000 1538.32 10.00

15 4395.66 28.57

Granivores 35 3556.56 23.12

1000 1538.32 10.00

Dose-Based EECs 

(mg/kg-bw)

Mammalian Classes and Body weight

(grams)

15 35 1000

Short Grass 89.30 61.72 14.31

Tall Grass 40.93 28.29 6.56

Broadleaf plants 50.23 34.72 8.05

Fruits/pods 5.58 3.86 0.89

Arthropods 34.97 24.17 5.60

Seeds 1.24 0.86 0.20

Dosebased 

RQs 

(Dose-based 

EEC/LD50 or 

NOAEL)

Small mammal Medium mammal Large mammal

15 grams 35 grams 1000 grams

Acute Chronic Acute Chronic Acute Chronic

Short Grass 0.02 3.13 0.02 2.67 0.01 1.43
25

Tall Grass 0.01 1.43 0.01 1.22 0.00 0.66

Broadleaf 

plants 0.01 1.76 0.01 1.50 0.01 0.80

Fruits/pods 0.00 0.20 0.00 0.17 0.00 0.09

Arthropods 0.01 1.22 0.01 1.05 0.00 0.56

Seeds 0.00 0.04 0.00 0.04 0.00 0.02