### 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 V I

Environmental Fate and Effe cts Division (7507P)

This memo contains the findings of an ecological r isk assessment for two new labels (Flu orpyram 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 applicati on, soybean seed treatment, and peanut applications . Fluorpyram is a fungicide and c urrent formulations for fluopyram include suspension

concen trates for the chemical alone (41.5% a.i), or with other fungicides includi ng tebuconaz ole

, trifloxystro bin , pyrimetha nil , or prothiocona zole . 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

see king 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

biochem ical 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 a nd Ecological Risk Assessments

The ecological risk assessment that was previously conducted was an E nvironmental 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

, strawbe rries, suga r beet, and tree nuts (DP Barcode: D353315 , 369756, and 385637 dated

8/29/11 ). Current formulations for fluopyram include s uspension 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 a nd a maximum seasonal a pplication rate of 0.444 lb a.i.

/ A

.

The results of this screening

- level risk assessment suggest the potential for chronic risk to non

target mammals, birds, reptiles and terrestrial

- phase amphibians based on modeled exposure resulting from spray applications of fluopyram. RQs for acute expo sure 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 l ow acut e risk concerns (at levels below the level s 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 m ammalian toxicity studies (DP Barcode: 396805). The corrected

calculations still indica te chronic risk concerns using dose

- base d RQs, although a noticeable shift in magnitude occurs. All die tary

- based RQs are below the level

- of

- concern

.

F luopyram shows lo w acute toxicity to terrestrial invertebrates on the basis of acute oral and

contact studies on bees. S ome reproductive effects to soil dwelling invertebrates were observed at high levels of fluopyram exposure (5.8 mg/L)

. Overall risk to terrestrial plan t 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 uncertai nty, 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. T he 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 non

definitive 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 restricti on : d o 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 max imum 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 2 0.066 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 3 0.138 Not Applicable Seed Treatment at planting

Peanuts 2 0.222 0.445 14 Assume Ground application at time of seeding (In

furrow) + another foliar application post

- emergence (Ground, Air Or Chemigation)

1 Form= 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 soyb ean 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 ne w 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

inst ead of PE

- 5 as per the recent EFED policy.

### 4



# III. Estimating Exposure EECs from Surface Water Sources

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

Assessme nt ( DP Barcode : 3533 1 5 , 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 1 st 

### application is with seeds at a depth of 1.27 cm and the 2 nd



### a pplication 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 1 st 

### application is in

- furrow by groun d equipment (0.062 drift) incorporated at a depth of 3.81 cm and the 2 nd 

### 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 a re 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

### 5



# IV. Effects Summary

Table 3 shows the acute and chronic effects data that were used for estimating risk to aqua tic 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 LC 50 >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 LC 50 >46.4 mg a.i./L

b 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 EC 50 >17 mg

a.i./L MRID 47372324

94.70% Daphnia magna NOAEC=17 mg a.i./L Acceptable

TEP Water flea

48 hours EC 50 >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 LC 50 >0.98 mg a.i./L a 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 EC 50 >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 :

LC 50 > 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 EC 50 = 4.3 mg

a.i./L MRID 47372403

94.70% NOAEC = 1.46 mg a.i./L Acceptable

(biomass)

TEP

Pseudokirchneriella

subcapitata 72 hours EC 50 = 3.4 mg

a.i./L MRID 47372407

41.50% NOAEC = 1.17 mg a.i./L Acceptable

(cell density)

Fluopyram

lactame (metabolite)

Pseudokirchneriella

subcapitata 72 hours EC 50 >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 EC 50 = 2.6 mg

a.i./L MRID 47372401

94.70% Lemna gibba NOAEC = 0.28 mg a.i./L Acce ptable

### 8 (frond number

based on yield)

TEP Duckweed

7 days EC 50 = 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 LD 50 > 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 LD 50 >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 LC 50 >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 diet a MRIDs

47372344

(94.7% a.i.) ( Colinus

Virginianus )

and Mallard duck ( Anas platyrhynchos ) Acceptable

LOAEC = 75.7 mg a.i./kg diet a 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 ) LD 50 >100
μg test
material/bee Contact

toxicity test:

Acceptable

Oral toxicity

LC 50 >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 ) LD 50 > 83.2 μg a.i./bee Contact

toxicity test:

Oral toxicity Acceptable

LC 50 > 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 EC 25 >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 EC 25 <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 EC 25 <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 EC 25 >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 EC 25 >0.222

lbs a.i./A MRID

(41% a.i.) NOAEC =

0.222 lbs

a.i./A 47372350

Acceptable



### *Bolded MRID indicates newly s ubmitted study for this assess ment.

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

scientific ally sound but because this study only examined the dicot buckwheat it is considered supplemental. I t 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 b uckwheat had inhibitions in emergence and survival of up t o 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. T here was no effect in the negative control or any treatment gr oup 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 identi fied either for listed or non

- listed species.

No chronic toxicity data are available for estuarine/marine invertebrates or fish. When possible the Agency uses t he 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

### 12

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

RQ (ug 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.

EC 50 NOAEC

or EC 05 Peak

Water

Column EEC (μg a.i./L) RQ RQs

Plant Type (μg

a.i./L) (μg

a.i./L) endangered species other non

target plants

(Peak

EEC/EC 50 )

c (Peak

EEC/NOAEC

or EC 05 ) 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 EC 50 = 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 EC 50 = 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 f ollowed 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 T

REX run are presented in Appendix 1.

Risks to both avian and mam malian taxa from seed trea t ments 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 i n 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 expos ure. 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 ma mmalian 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 sugge sting 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 t hat listed species may potentially be adversely a ffected 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.

Th e 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

c otton.

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 t his 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 applica tion 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 c hronic 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

- R EX

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 ch ronic 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 fo llowed 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 f or peanuts (Table 10). Dosed

- based chronic risk to mammals was identified for short grass, tall grass, broadleaf plants and arthropods. T he RQs for short grass

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

w hile 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 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 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 o f 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 0.22 2 lbs a.i./A. The original buckwheat study submitted for the previous risk assess ment 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 f rom 0.002 (spray drift) to 0.0576 (semi

- aquatic areas) lbs a.i./A for ground application for the cotton applic ation 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 scen arios 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 semi

aquatic areas. For the cotton scenario with combined application rates of 0.288 lb a.i./A RQs

### 18

di d 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

trea t ments with soybeans potentially adversely affecting listed small a vian 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 ind icated 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 indica ted 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 present ed 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 co mes 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) 

### 8.8 7

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/kg

bw/day) (mg ai/kg

bw/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



# Dose

based
RQs

(Dose

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

15 grams 35 grams 1000 grams

Acute Chronic Acute Chronic Acute Chronic

Short Grass 0.02 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