Page 1 of 125



## Revised Ecological Risk Assessment for the Section 3 New Use

Registration of Tolfenpyrad

IUPAC Name: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [4

- ( p

- tolyloxy)benzyl]pyrazole

- 5

- carboxamide.

CAS Name: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [[4

- (4

- methylphenoxy)phenyl]methyl]

- 1 H

pyrazole

- 5

- carboxamide.

CAS Number: 129558

- 76

- 5.

U.S. EPA PC Code: 090111

DP Barcode: 408705

Team Members Larry Liu, Fate Scientist Brian Montague, Fishery Biologist

Peer Review Justin Housenger , Biologist Keith Sappington, Senior Science Advisor Dr. Michael Barrett, Senior Fate Scientist

ERB5 Branch Chief

Mah Shamim

Date of ApprovalPage 2 of 125



## Contents

1 Executive Summary

................................ ................................ ................................ ................................ ...... 4

2.0 Problem Formulation

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

2.1 Nature of Regulatory Action

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

2.2 Stressor Source and Distribution

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

2.2.1 Mode of Action and Nature of the Chemical Stressor

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

2.3 Pesticide Use Characterization and Scope of the Potential Use Area

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

2.4 Receptors

................................ ................................ ................................ ................................ ....................... 11

2.4.1 Aquatic and Terrestrial Effects

...................................................................................... 11

2.4.2 Ecosystems Potentially at Risk

...................................................................................... 11

2.4.3 Ecological Effects

..................................................................................................... 12

2.5 Conceptual Model

..................................................................................................................... 12

2.5.1 Risk Hypotheses

....................................................................................................... 12

2.5.2 Conceptual Diagram

................................................................................................ 13

2.6 Analysis Plan

........................................................................... ................................................ 15

2.6.1 Measures of Exposure and Effects

................................................................................. 15

2.6.2 Data Gaps

.............................................................................................................. 17

3.0 Exposure Analysis

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

3.1 Use ch aracterization

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

3. 2 Environmental Fate and Transport Characterization

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

3.2.1 Fate in water

............................................................................................................ 26

3.2.2 Fate in air

............................................................................................................... 26

3.2.3 Field Studies

........................................................................................................... 26

3.2.4 Bioconcentration Studies

...................................................... ....................................... 27

3.2.5 Fate Properties of Transformation Products

....................................................................... 27

3.3 Aquatic Exposure Estimates

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

3.3.1 Modeled Exposure in Surface Water and Pore Water

............................................................ 30

3.3.2 Aquatic Exposure Monitoring and Field Data

..................................................................... 32

3.4 Terrestrial Wildlife Exposure Estimates

................................ ................................ ................................ ........ 32

3.4.1 Inhalation Exposure

................................................................................................... 34

3.4.2 Dermal Exposure

...................................................................................................... 34

3.4.3 Drinking Water Exposure

....................................... ..................................................... 34

3.4.4 Exposure of Piscivorous Wildlife

................................................................................... 35

3.5 Terrestrial and Semi

- Aquatic Plant Exposure Estimates

................................ ................................ .............. 37

4.0 Ecological Effects Analysis

................................ ................................ ................................ ........................ 38

4.1 Aquatic Effects Summary

................................ ................................ ................................ ............................... 38

4.1. 1 Toxic Effects to Fish

.................................................................................................. 38

4.1.2 Toxic Effects to Aquatic Invertebrates

............................................................................. 41

4.1.3 Toxic Effects to Aquatic Vascular Plants and Algae

............................................................. 43

4.2 Terrestrial Effects Summary

................................ ................................ ................................ .......................... 44

4.2.1 Toxic Effects on Birds

................................................................................................ 44

4.2.2 Toxic Effects on Mammals

.......................................................................................... 46

4.2.3 Toxic Effects on Terrestrial Invertebrates

......................................................................... 48

4.2.4 Toxic Effects on Terrestrial Plants

................................................................................. 49Page 3 of 125

4.5 Review of ECOTOX Data

................................ ................................ ................................ .............................. 50

4.6 Review of Incident Data

................................ ................................ ................................ ................................ 50

5.0 Risk Characterization

................................ ................................ ................................ ................................ . 51

5.1 Risk Estimation Process: Integration of Exposure and Effects Data

................................ ............................ 51

5.1.1 Non

- target Aquatic Fish, Invertebrates, and Plants

.................. ............................................. 51

5.1.2 Non

- target Terrestrial Animals (Terrestrial Diet)

................................................................. 54

5.1.3 Non

- target Terrestrial Animals (Aquatic Prey)

................................................................... 58

5.1.4 Terrestrial and Semi

- aquatic Plants

................................................................................. 59

5.1.5 Non

- Target Insect Pollinators

....................................................................................... 59

5.2 Risk Description

................................ ................................ ................................ ................................ ............ 61

5.2.1 Risks of Tolfenpyrad to Aquatic Organisms

...................................................................... 61

5.2.2 Risks of Tolfenpyrad to Terrestrial Organisms

................................................................... 64

6.0 Description of Assumptions and Limitations

................................ ................................ ............................ 68

6.1 Assumptions and Limitations Related to Exposure for all Taxa

................................ ................................ .... 68

6.2 Assumptions and Limitations Related to Exposure for Terrestrial Species

................................ ................... 68

6.3 Assumptions and Limitations Related to Exposure for Aquatic Species

................................ ........................ 69

6.4 Assumptions and Limitations Related to Effects Assessment

................................ ................................ ......... 70

7.0 Literature Cite d.........................................................................................................71

Appendix A. Summary of minor degradates formation from degradation of tolfenpyrad and the chemical

structures Appendix B. Proposed route of degradation of tolfenpyrad in aerobic soil system and minor degradate

formation Appendix C. Model Descriptions/ Inputs/ Outputs Appendix D. Risk Quotient Methods and Level

- of

- Concern Definitions

A ppendix E

. KABAM Bioaccumulation Assessment Results Appendix F . Health Effects Division mammalian toxicity profile Appendix G. ECOSAR results for tolfenpyrad and its major degradation products Appendix H

. Endangered Species Policy and Guidance InformationPage 4 of 125



## 1 Executive Summary

Nichino America is seeking new registrations for the active ingredient tolfenpyrad. These proposed registrations would be the first outdoor uses of the chemical (indoor greenhouse use is now registered)

. Nichino has made significant changes to the original ly proposed 2012 label

rates , removed aerial use on certain crops

, and removed some crop uses with higher application

rates. This current assessment is based on the 2013 revised labels for tolfenpyrad 15EC and

t olfenpyrad 15SC. The proposed uses of tolfenpyrad for both products include citrus fruit (Crop Group 10), grapes (raisin, table, wine), apple, crabapple, loquat, mayhaw, quince, pear (oriental pear), leafy vegetables (Crop Group 4), cucurbit vegetables (Cr op Group 9), potatoes, brassica (cole) leafy vegetables (Crop Group 5), fruiting vegetables (Crop Group 8 plus okra), cotton

, stone fruit (Crop Group 12), tree nuts (Crop Group 14), and Ornamental greenhouse uses. Outdoor uses listed above consist of signi ficant potential acreage exceeding 16 million acres (based 2007 USDA Agricultural Census).

Tolfenpyrad is a pyrazole insecticide proposed for use to control thrips, aphids and scales through the egg, larval, nymph, and adult stages. Tolfenpyrad has activi ty against several economically important insect pests of vegetable, fruits, nuts, vines, and row crops. It is active on Hemiptera, Thysanoptera, Lepidop t era, Coleoptera, Diptera, Orthoptera, Eriophid mites and Tarsonemid mites. It has activity on all deve lopment stages of target insects. Tolfenpyrad also has fungicidal activity against certain species of powdery mildew and downy mildews.

The original ecological risk assessment was completed in 2012. In th e 2012 risk assessment,

EFED used a total toxic r esidue (TTR) method for surface water and pore water estimated

environmental concentrations ( EECs ) that included tolfenpyrad and its four major degradates (PCA, PT

- CA, PT(A)

- 4OH, and PAM). In early 2013, the registrant submitted two revised

labels and fou r rainbow trout toxicity studies performed with these degradates

. F indings in those

four studies indicated that the degradates are much less toxic than the parent compound. Based on this data, a determination was made that only parent tolfenpyrad will be included in the

current risk assessment of the proposed tolfenpyrad uses.

Environmental F

ate Profile

Tolfenpyrad and its transformation products are expected to undergo moderate degradation in the environment. In soil, tolfenpyrad is expected to be hardly mobile (with K OC 

### 29,380). Two major acidic degradates detected in the soil and aquatic metabolism studies (PCA and PT

- CA ) are mobile , with K OC 

### values of 12.5 and 19, respectively. Tolfenpyrad has the potential to

contaminate sur face water via spray drift and runoff of residues sorbed to sediment. The high

octanol

- water partition coefficient for tolfenpyrad (log K OW 

### = 4.3

- 5.6) suggests a potential for bioaccumulation in aquatic food webs. B ased on total radioactivity

- based resid ues, the BCF in

whole fish is 4,168 , confirming its relatively high bioaccumulation potential. However, this BCF is lower than what would be predicted based on high K OW 

### alone, which indicates tolfenpyrad is

metabolized by fish to a significant extent

.Page 5 of 125



### It should be noted that tolfenpyrad was modeled in this assessment as relatively persistent if only one metabolism study type was available. If additional metabolism and mobility studies are available, EECs could be refined and may result in lower values.

Ecological T

oxicity P rofile

Tolfenpyrad is classified as very highly toxic to freshwater fish ( LC 50 

### = 0.16 μg a.i./L ) and aquatic invertebrates (E C 50 

### = 1.0 μg a.i./L ) on an acute exposure basis. It is also highly toxic to estuarine/marine fish ( LC 50 

### = 3.4 μg a.i./L ) on an acute exposure basis. The formulated product showed similar toxicity as the TGAI to fish and aquatic invertebrates. The NOAEC for c hronic

effects on survival, growth and reproduction of freshwater and estuarine/marine fish occurre d as

low as 0.18 μg TRR/L. Chronic reproduction effects to freshwater invertebrates were observed at

0.48 μg a.i./L with NOEC at 0.24 μg a.i./L

. Toxicity to some algal species is also observed at low levels, with an acute EC 50 

### of 1.0 μg a.i./L

. However, toxicity to aquatic vascular plants was not observed at concentrations approaching the limit of solubility of tolfenpyrad in water. Importantly, recent data submitted on the acute toxicity of four degradates of tolfenpyrad ( PAM,

PCA

, PT

- CA and PT( A)

- 4OH ) indicate the degradates are much less toxic than parent material to fish by at least three orders of magnitude.

With birds, tolfenpyrad is classified as moderately toxic on an acute oral exposure basis (LD 50 

### = 87 mg a.i./kg

- bw) and slightly toxic on an acute dietary basis (LC 50 

### = 1348 ppm in the diet).
However, c hronic effects to egg production observed in birds at 9.7 ppm and 24 ppm for mallard and bobwhite quail

. Because adverse effects were observed at all treatment levels in these studies, the chronic avian NOAEC cannot be determined at this time.

Tolfenpyrad is classified as moderately toxic to mammals on an acute exposure basis (LD 50 

### = 239 mg a.i./kg

- bw) but displays much greater toxicity on a chronic exposure basis (NOAEC = 0.86 mg a.i./kg

- bw/d). It is also highly toxic to the honey bee, with an acute contact LD 50 

### of 0.47 ug a

. i

. /bee and an acute oral LD 50 

### of 0.63 ug a

. i

. /bee . With terrestrial plants, EC25 values exceeded the maximum single application rate of 0.27 lb a.i./A.

Ecological Risk Summary

Based on newly estimated environmental concentrations

, this scre ening

- level risk assessment

indicates that the proposed new uses of tolfenpyrad pose potential acute risks to fish, amphibians, freshwater invertebrates, birds, mamma ls and some species of algae ( Table 1.1 )

. The potential

for c hronic risks to freshwater and estuarine/marine fish, birds, terrestrial

- phase amphibians, reptiles, and mammals is also evident based on the proposed label application rates and modeled

exposure levels. High acute toxicity to honey bees indicates acute risk is possible to non

- target pollinators from acute contact, direct ingestion of residues, or exposure to treated foliar surfaces. All proposed uses resulted in risk estimates that exceeded leve ls

- of

- concern for terrestrial and aquatic organisms, with the exception of vascular aquatic plants. Secondary risks are predicted for piscivorous mammals and birds.Page 6 of 125



### Table 1.1. Ecological risk estimation summary for tolfenpyrad

Taxon Acute Risk Chronic Ris k

Acute LOC

Exceeded? ( Yes/No ) (3) Acute RQ

Range Chronic LOC

Exceeded?

Yes/No (4) Chronic RQ

Range

Birds (1) Yes <0.01

- 2.5 Yes >0.6

- >14

Mammals Yes <0.01

- 0.25 Yes 0.4

- 70

Bees and other Insect

Pollinators Yes 1.6

- 23 NA NA

Freshwater fish (2) Yes 0.7

- 17 Yes 0. 05

- 3.6

Freshwater

invertebrates Yes 0.1

- 2.7 Yes 0.04

- 2.9

Marine/estuarine fish Yes 0.03

- 0.8 3 Yes 0. 0 5

- 2.5

Marine/estuarine

invertebrates Yes <0.01

- <0.3 6 No 0.0 2

- 0. 38

Aquatic plants NA NA Nonvascular

– Yes

Vascular

– No 0.1

- 5. 6

<0.01

- 0.09

Terrestrial and semi

aquatic plants

– monocots and dicots NA NA Dicots

– No

Monocots

- No ND

(1) In absence of toxicity data, birds are used as a surrogate for reptiles and terrestrial

- phase amphibians. (2) In absence of toxicity data, freshwater fish are used as a surrogate for aquatic

- phase amphibians. (3) The acute LOC for listed and non

- listed aquatic animals is 0.05 and 0.5, respectively. (4) The chronic LOC for listed and non

- listed aquatic and terrestrial animals is 1.0. NA = not applicable; ND = not determined . RQ values that exceed the listed species LOC are shown in bold

.



### Data gaps

The following e nvironmental f ate d ata gaps have been identified , which if filled, could materially affect the risk assessment conclusions :

Aerobic Soil Metabolism (835.4100)

Since only one aerobic soil w as selected from CA, the submitted stud y do es not represent
all the proposed use area s and its half

- life was multiplied by three as a safety factor in modeling to account for expected variability . Acc ordi ng to the proposed labels, tolfenpyrad can be used on citrus fruit, grapes, apple, crabapple, loquat, mayhaw, quince, pear, leafy vegetables, cucurbit vegetables, potatoes, brassica (cole) leafy vegetables, fruiting vegetables, cotton, stone fruit, tree nu ts, and greenhouse. If t he registrant wou ld

submit additional aerobic soil metabolism studies in which soil samples are collected from the proposed use areas , aquatic EECs could be lower

.

Fish Bioconcent r ation (850.1730) The submitted fish bioconcentration study neither measured tolfenpyrad nor identified degradates in fish tissues, but shows a potential for bioconcentration of these chemicals (BCF = 4,168 L/kg w.w. in whole fish) based on total radioactive residues in fis h tissue

and water. Although any in vivo biotransformation of tolfenpyrad by fish would result inPage 7 of 125



### less parent material in fish tissue (and a lower BCF based on parent chemical), metabolism of the chemical in the exposure water would lead to a higher BCF b ased on parent chemical in water). Therefore, considering the high bioaccumulation potential of tolfenpyrad in fish, its persistence and the large spatial scale of its proposed use patterns, a new BCF study in which residues of parent chemical and metabol ites are measured should be submitted to the Agency.

Although an a naerobic a quatic m etabolism (835.4400) study was submitted using only one water/sediment system , additional data are not being requested because such data would not likely alter the risk conclusions. Specifically, the existing anaerobic aquatic metabolism half life ( 385 days) was multiplied by 3X to address uncertainty associated with the availability of degradation rate information for less than two aquatic/sediment systems. Removal of this 3X factor would not materially affect the aquatic risk conclusions given that the existing half life is still very long ( 385 days).

The following ecological toxicity data gaps have been identified , which if filled, could materially

affect the risk c onclusions :

Whole sediment toxicity, freshwater and estuarine/marine (/chronic)

. Based on the proposed use pattern and environmental fate properties of tolfenpyrad, it is expected to partition extensively to aquatic sediments. In consideration of its high toxicity to aquatic invertebrates, whole sediment toxicity data are needed to evaluate the potential for chronic toxicity to benthic invertebrate species.

Avian reproduction test, upland gamebird and waterfowl species (850.2 300)

. A chronic

avian NOAEL was not determined but is estimated at < 9.7 ppm for mallard and < 24.3 ppm for bobwhite quail based on observed effects in these studies (MRIDs 48250428, 48250429

, 48250430

, 48250431 ) . There is need to determine the safe level of chronic exposure to birds for the purposes of accurately determining chronic risk to birds.

Additional Exposure and Effects Data for Bees. The Tier 1 risk assessment indicates acute

LOC are exceeded from bo th the diet and contact routes of exposure for honey bees. Since the Tier 1 risk assessment is based on conservative assumptions regarding exposure, additional data the residues of tolfenpyrad in pollen and nectar would help to refine the Tier 1 dietary r isk

assessment results. Such residue information can be obtained from field residue trials with the product applied to one or more crop s in accordance with the label. Pending results of the refined Tier 1 assessment, results on the effects of tolfenpyrad on honey bees at the whole hive level may be needed. Alternatively, risk mitigation measures can be taken to avoid exposure of bees to tolfenpyrad, such as restricting applications during periods of bloom.Page 8 of 125



## 2.0 Problem Formulation

2.1 Nature of Regulat ory Action

The purpose of this assessment is to evaluate the environmental fate and ecological risks for the proposed new outdoor use registrations of the chemical tolfenpyrad and to evaluate the potential

to cause unreasonable adverse effects to the environment, as required under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). Potential effects to Federal endangered and threatened wildlife and plants are also considered under the Endangered Species Act in order to ensure that the regist ration of tolfenpyrad is not likely to jeopardize such listed species or adversely modify their habitat. To these ends, this assessment follows U.S. EPA’s guidance on conducting ecological risk assessments and policies for assessing risk to non

- target and listed organisms (U.S. EPA, 1998 and U.S. EPA, 2004).

The U.S. EPA pesticide registration process is a determination of whether a pesticidal product is eligible for registration and, if so, an enforceable description of how the pesticide may be used.

A l abel represents the legal document which stipulates how and where a given pesticide may be

used. End

- use labels describe the formulation type, acceptable methods of application, where the product may be applied, and any restrictions on how applications may be conducted. Thus, potential use described by the propose pesticide labels is assessed.

2.2 Stressor Source and Distribution

2.2.1 Mode of Action and Nature of the Chemical Stressor

Tolfenpyrad is a pyrazole insecticide proposed for use to control thr ips, aphids and scales through the egg, larval, nymph, and adult stages. It is also labeled for use as contact fungicide on the newest label. Tolfenpyrad impairs energy metabolism in the target pest. It works by inhibiting cellular respiration in the mito chondria. As a result, Tolfenpyrad causes rapid cessation of feeding and death of the pest usually within 24

- 48 hours. The chemical is classified as a Group 21A mitochondrial complex I electron transport inhibitor ( METI) insecticide (IRAC, 2011). See Secti on 3.2.1 for a summary of the chemistry and environmental fate data for tolfenpyrad

.

2.3 Pesticide Use Characterization and Scope of the Potential Use Area

The proposed uses of tolfenpyrad include citrus fruit (Crop Group 10), grapes (raisin, table, wine) , apple, crabapple, loquat, mayhaw, quince, pear (oriental pear), leafy vegetables (Crop Group 4), cucurbit vegetables (Crop Group 9), potatoes, brassica (cole) leafy vegetables (Crop Group 5), fruiting vegetables (Crop Group 8 plus okra), cotton, stone fr uit (Crop Group 12), tree nuts (Crop Group 14), and ornamentals in greenhouses. The proposed use areas are found throughout the United States and are not limited to a particular geographic region. Since these are the first proposed outdoors uses of tolfen pyrad in the United States, no prior crop usage data

is available. The proposed uses encompass a potential acreage of over 16 million acres based onPage 9 of 125



### USDA 2007 Crop Census estimates. Cotton represents the largest portion of the crop acreage potential, fol lowed by tree nuts, potato, grapes and citrus. This analysis may be revised when the new 2012 USDA census is completed. Many minor crops in these categories on the Tolfenpyrad labels were not covered individually in the census. Indoor greenhouse use is not included below.

Table 2.1 Major Crop Acreage Estimates Based on USDA 2007 Agricultural Census Crop Group Major groups estimated by USDA* U.S. acreage totals

Citrus Limes, grapefruit, orange, lemon, tangerine 1,005,806

Cotton Cotton all states 10,493,238

Cucurbits Cucumber, honeydew, watermelon, pumpkin,

squashes (all) ,cantaloupe, and other melons 541,161

Fruiting Vegetables Tomatoes (all types) , bell peppers, other peppers,

eggplant, okra , and huckleberry 547,998

Brassica Vegetables B roccoli , cabbage (all), brussel sprout, cauliflower,

kale, mustard greens, and collards 281,209

Grapes (all) Raisin, table, and wine 1,051,047 Leafy Vegetables Celery, spinach, rhubarb, parsely , lettuce (head and

leaf types) 392,658

Pome Fruit Apples, pears, other non

- citrus 476,986

Potato Sweet and white potatoes 1,131,963

Stone Fruit Apricot, cherries(sweet & tart), nectarine, peach,

plum, prune, pomegranate, and persimmon 483,126

Tree nuts Almond. c hesnut, filberts, hickory, macadamia, pecan,

pistachio, walnut, and others 1,857,179

This assessment includes the products Tolfenpyrad 15EC and Tolfenpyrad 15SC. Tolfenpyrad 15EC is formulated as a 15% active ingredient emulsifiable concentrate (1.29 lb ai/gal) and also

known as Hachi

- Hachi ® 

### or Rycar ®



### . Tolfenpyrad 15SC is formulated as a 15% active ingredient soluble concentrate (1.31 lb ai/gal) and is also called Torac ® 

### . Tolfenpyrad 15EC is currently registered for a greenhouse use only in the United States.

According to the proposed labels, applicati ons will be made using air, ground, airblast, air curtain and chemigation equipment. Table 2.2 contains the proposed use information, including single and seasonal application rates, maximum number of applications, etc. for each use. Rates of application f

or crops range from 0.14 to 0.27 lbs a.i./A in varying numbers of gallons of

diluent. Rates of application for ornamental plants in greenhouse range from 0.20 to 0.31 lbs a.i. per 10,000 square feet. Use restrictions on the proposed label include a 150 fe et buffer for aerial applications near fish

- bearing aquatic habitats to protect endangered species. A 15

- foot vegetative buffer between field edge and down

- gradient aquatic habitats is also included on the proposed labels. Spray drift management provisio ns include avoiding aerial applications when wind speed is greater than 10 mph and during periods of temperature inversions. The use of tolfenpyrad in the state of New York is prohibited

.Page 10 of 125



### Table 2. 2 Revised New Uses of Tolfenpyrad (Formulations 15EC and 1 5SC).

Use Sites Application Method

(Buffer Zone) Single

Application Rate (lb ai/A) Maximum

Applications per Season Minimum

Application Interval (days) Maximum Seasonal

Application Rate

(lb ai/A)

Citrus fruit (Crop Group 10

- 10) ground application

or aerial application (with 150

- ft buffer zone) 0.14

- 0.27 2

4 per year 14 0.54

Cotton ground application or

aerial appl ication ( west of MS river only, with 150

- ft

buffer zone ) 0.14

- 0.21 2 14 0.42

Grapes (raisin, table, wine) ground appl ication

only 0.14

- 0.27 2 14 0.41

Brassica (cole) leavy vegetables (Crop Group 5) ground application or

aerial appl ication (with 150

- ft buffer zone) 0.14

- 0.21 2 14 0.42

Pome fruit (Crop Group 11

- 10) ground appl ication

only 0.14

- 0.27 2 14 0.41

Brassica (cole) leavy vegetables (Crop Group 5) ground application or

aerial application (with 150

- ft buffer zone) 0.14

- 0.21 2

4 per year 14 0.42

Leafy vegetables (except Brassica veg.)(Crop Group 4) ground application or

aerial application

west of MS river (with 150

- ft buffer zone) 0.14

- 0.21 2

4 per year 14 0.42

Cucurbit vegetables (Crop Group 9) ground application or

aerial appl ication

west of MS river (with 150

- ft buffer zone) 0.14

- 0.21 2

4 per year 14 0.42

Fruiting vegetables (Crop Group 8

- 10) ground application or

aerial application

west of MS river (with 150

- ft buffer zone) 0.14

- 0.21 2

4 per year 14 0.42

Stone fruit (Crop Group 12) ground appl.

0.14

- 0.27 2 14 0.54

Tree nuts (Crop Group 14) ground appl. 0.14

- 0.27 2 14 0.54Page 11 of 125

Use Sites Application Method

(Buffer Zone) Single

Application Rate (lb ai/A) Maximum

Applications per Season Minimum

Application Interval (days) Maximum Seasonal

Application Rate

(lb ai/A)

Potatoes ground application

or aerial application

west of MS river

buffer zone not required ) 0.14

- 0.21 2 14 0.42

Ornamental plants in greenhouse ground appl. 0.20

- 0.31 lb ai/10,000 sq ft 2 10 0. 62 lb ai/10,000 sq

ft

Notes: 1. Tolfenpyrad is not registered for use or sale in the state of New York.

2. Labels state the maintenance of a minimum 15

- foot wide vegetable filter strip for all crops. 3. Tolfenpyrad 15EC Insecticide (15% a.i.) EPA Reg No. 71711

- 31 (1.29 lb ai/gal); Tolfenpyrad 15SC Insecticide (15% a.i.) EPA Reg No. 71711

- XX (1.31 lb ai/gal)



### 2.4 Receptors

2.4.1 Aquatic and Terrestrial Effects

The receptors are the biological organisms that are exposed to the chemical stressor (U.S. EPA, 1998). Agency risk assessments use a surrogate species approach in evaluation of pesticides. Toxicological data generated from surrogate test species is intended to be representative of broad taxonomic groups and are used to extrapolate to potential effects on a variety of species.

Acute and chronic toxicity data includes studies submitted by pesticide registrants and/or

available in open literature. This includes toxicity data on the technical grade active ingredient, degradates, and formulated products when available.

Open literature stud ies are primarily identified through U.S. EPA’s publicly available ECOTOX

database http://cfpub.epa.gov/ecotox/ ) literature search engine

. The evaluation of unpublished registrant submissions and published sour ces of data may provide insight into the direct and indirect effects of tolfenpyrad on biotic communities from loss of species that are sensitive to the chemical and from changes in structure and functional characteristics of affected communities.

2.4.2 Ecosystems Potentially at Risk

In general terms terrestrial ecosystems potentially at risk could include the treated field or orchards and areas immediately adjacent to the treated field or orchard that may receive drift or

runoff. Terrestrial habitats adj acent to the treated area could include other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats

and uncultivated areas.

Freshwater aquatic ecosystems include water bodies adjacent to or downst ream from the treated field including water bodies such as ponds, lakes, reservoirs, semi aquatic habitats such as marshes or ditches and flowing waterways such as streams or rivers. In coastal areas aquatic habitat may includes salt mashes, tidal rivers, irrigation canals and bogs.Page 12 of 125



### 2.4.3 Ecological Effects

Ecological measurement endpoints for this risk assessment would be based on toxicity information for tolfenpyrad in a suite of registrant

- submitted toxicity studies and in the publicly available open lit erature including the ECOTOX database.

With outdoor uses of conventional pesticides under FIFRA

, registrant

- submitted toxicity studies

are generally required for organisms in the following broad groupings:

1. Birds (mallard duck or bobwhite quail and a pa sserine species): Birds are also used as a surrogate species for terrestrial

- phase amphibians and reptiles

2. Freshwater fish ( generally rainbow trout and bluegill sunfish ): Fish values are used as a surrogate data for aquatic

- phase amphibians if no amphibian data is available.

3. Freshwater invertebrates : (usually crustacea such as Daphnia sp.)

4. Estuarine/marine fish : ( generally the sheepshead minnow)

5. Estuarine/marine invertebr ates : (Mollusc and Crustacean usually Oyster or Mysid)

6. Terrestrial plants : (monocots and dicots

– 10 species)

7. Aquatic plants : (vascular and non

- vascular plants

– 5 species)

8. Terrestrial Pollinator Insect : (honeybee)

9. Mammals : (laboratory rat are generally used as a surrogate for wild mammals)

Within each of these very broad taxonomic groups, an acute and /or chronic endpoint is selected

from the availabl e test data if testing with those taxa are available. Data submitted for other taxonomic groups may be r eviewed and considered as well. Data for metabolites of concern and certain formulations may also be required on a case by case basis.

2.5 Conceptual Model

A conceptual model provides a written description and visual representation of the predicted

relati onships between the potential routes of tolfenpyrad exposure and the predicted effects for the assessment endpoint. A conceptual model consists of two major components: risk hypotheses and a conceptual diagram (U.S. EPA, 1998).

2.5.1 Risk Hypotheses

For to lfenpyrad, the following ecological risk hypothesis is being employed for this risk

assessment:

Given the widely proposed uses of tolfenpyrad and its environmental fate properties, there is a likelihood of exposure to non

- target terrestrial and aquatic or ganisms.

When used in accordance with the label, tolfenpyrad will result in potential adverse effects upon the survival, growth, and reproduction of non

- target terrestrial and aquatic organisms.Page 13 of 125



### 2.5.2 Conceptual Diagram

In order for a chemical to pose an ecological risk, it must reach habitats and organisms in biologically significant concentrations. An exposure pathway is the means by which a contaminant moves in the environment from the point of application to the effected organisms.

Environmental tra nsport medium must include a feasible route of exposure. In addition, the potential mechanisms of transport and transformation must be understood, especially for metabolites or degradates of toxicological concern. The assessment of ecological exposure path ways, therefore, includes an examination of the source, the potential migration pathways for the chemical, and the determination of potential exposure routes for the organisms exposed including ingestion, inhalation, direct contact and dermal absorption pa thways

. Figures 2

- 1 and

2

- 2 represent conceptual models of exposure pathways for terrestrial organisms that may be potentially exposed to tolfenpyrad. Figure 2

- 3 contains the conceptual model for potential exposure of aquatic organisms to tolfenpyrad.

Figure 2

- 1 . Conceptual diagram for tolfenpyrad effects on terrestrial organisms via commonly assessed exposure routes

. Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk. 

## Stressor

Source

Receptors

Attribute Change Applications of Tolfenpyrad

Direct application Spray drift

Birds / Terrestrial

phase amphibians / reptiles / mammals/

Insect s Juvenile

Adult Terrestrial

i nver ts

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain

Reduction in

prey Habitat integrity Reduction in primary productivity

Reduced cover Community change Terrestrial/riparian plants grasses/forbs, fruit, seeds (trees, shrubs) Runoff

Mammals 

## Exposure

Media Soil

Ingestion Ingestion

Ingestion Ingestion Dermal uptake/Ingestion A tmospheric

transport

Root uptake
Wet/dry

deposition

Birds / Amphibians IngestionPage 14 of 125



### Figure 2

- 2 . Conceptual diagram for tolfenpyrad effects on terrestrial organisms via drinking water and inhalation.

.

Figure 2

- 3 . Conceptual diagra m for tolfenpyrad exposure and effects on aquatic organisms.Page 15 of 125



### Mechanisms of release of tolfenpyrad based on current label applications are air, ground,

airblast

, air curtain and/or chemigation application of emulsifiable and suspension concentrate products. The conceptual model and subsequent analysis of exposure and effects are based on the parent tolfenpyrad. Though four degradates (PCA, PAM, PT

- CA, and PT(A)

- 4OH) are ex pected to be present

, their low acute toxicity to fish indicates they will be of low initial concern for fish within aquatic habitats. No data is available to charact eriz e their potential to adversely a ffect

terrestrial vertebrate s, aquatic invertebrate s or aquatic and semi a quatic plants. However, for aquatic invertebrates and algae, ECOSAR estimates of toxicity suggest the degradates are substantially less toxic than the parent chemical ( Appendix G )

.

Volatilization is not expected to be a significant route of dissipation f or this chemical as the Henry’s Law constant for tolfenpyrad is 1.7x10 - 6 

### atm•m 3 

### •mol

- 1



### . Concentrations of tolfenpyrad and its degradates, when sorbed to soil and transported to surface waters may be ecologically significant when runoff events occur or if o ff target spray drift after aerial or airblast application in close proximity to the treatment area occurs. Tolfenpyrad is not likely to leach to ground water whereas its acidic degradates (PCA and PT

- CA) may leach to ground water. Based on its high hydro phobicity and BCF approximating 4000 L/kg w.w., the potential exists for bioaccumulation of tolfenpyrad in aquatic food webs and subsequent exposure to piscivorous

wildlife.

2.6 Analysis Plan

This assessment characterizes the environmental fate and effects of tolfenpyrad and determines whether there is potential for risks to non

- target organisms based on the proposed use patterns. In order to complete this process available environmental fate, ecotoxicity, and physicochemical property data were taken from s tudies submitted to the Agency. Studies were first reviewed to determine their acceptability relative to published U.S. EPA guidelines.

The risk quotient approach used to estimate the potential for adverse effects on non

- target terrestrial and aquatic organisms compares estimated exposure levels to laboratory

- derived toxicity values. For the screening

- level assessment of tolfenpyrad, the deterministic, risk quotient (RQ) method has been used to compare model estimated exposure with measured toxicity v alues. Estimated Environmental Concentrations (EECs) are divided by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s levels of concern (LOCs) (USEPA 2004a). These criteria are used to indicate if applications of tolfen pyrad, as directed on the label, will have the potential to cause adverse effects to non

- target organisms by

exceedance of these thresholds.

In the event that endpoints from submitted ecotoxicity studies are non

- definitive, the Guidance for Using Non

- Defi nitive Endpoints in Evaluating Risks to Listed and Non

- listed Animal Species and the Guidance for Using Non

- Definitive Endpoints in Evaluating Risks to Listed and

Non

- listed Plant Species will be consulted (U.S. EPA, 2011a and U.S. EPA, 2011b).

2.6.1 Meas ures of Exposure and Effects

Methods for Prediction of Exposure LevelsPage 16 of 125



### The proposed label application rates for the use of tolfenpyrad on representative food and non

food crops were selected for modeling environmental concentrations for this base

- level

d eterministic (risk

- quotient based) assessment. The most sensitive toxicity endpoints from surrogate test species are used to estimate treatment

- related effects on survival, growth, and reproduction. EECs used in the aquatic ecological risk assessment are based on the parent tolfenpyrad. Degradate testing produced much less toxic endpoints than the parent for freshwater fish (the most sensitive tested group for technical ai) and these estimated concentrations were not

modeled.

For the aquatic assessment, EECs are produced by use of the latest version PRZM/EXAMS

model.

Terrestrial exposure is estimated with the following models. More detailed explanations may be

obtai ned in appendices or by web access at http://www.epa.gov/oppefed1/models/terrestrial/

. Actual model runs and outputs ar e also included in the appendix C

.

The T

- REX model ( Version 1.5 .1) calculates the residues on avian and mammalian food items to estimate acute and chronic dietary exposure and risk. As a conservative approach, the modeled environmental exposure concentrations are the single

- day maximum.

The TerrPlant model (version 1.2. 2) provides screening level estimates of exposure to terrestrial plants from single pesticide applications. TerrPlant derives pesticide EECs in chemical drift and runoff. The model does not consider exposures to plants from multiple pesticide applications. RQs are developed for non

- listed and listed species of monocots and dicots inhabiting dry and

semi

- aquatic areas which are adjacent to pesticide treatment sites.

T he potential for inhalation risk to birds and mammals was assessed using the Screening Too l for Inhalation Risk (STIR, version 1.0, November 2010).

Drinking water exposure potential for mammals or birds is predicted using Screening Imbibition Program (SIP 1.0, July 2010) using tolfenpyrad’s solubility and the highest application rate.

The KA BAM model (K OW 

### (based) Aquatic BioAccumulation Model) version 1.0 was used as the primary tool for evaluating the potential exposure and risk to birds and mammals tha t feed on aquatic organisms. This model will be applied in consideration of existing data on bioconcentration for tolfenpyrad and selected model parameters ( e.g., in vivo metabolism rate or Km) may be adjusted to reflect current information.

Measures of Effect

Table 2.2 lists the measures of environmental exposure and ecological effects used to assess the potential risks of tolfenpyrad to non

- target organisms (U.S. EPA, 2004).Page 17 of 125



### Table 2.2. Measures of Environmental Exposure and Ecological Effects Used to Assess the

Potent ial Risks of Tolfenpyrad to Non

- target Organisms
Assessment Endpoint Abundance ( i.e.

, survival, reproduction, and growth) of

individuals and communities Measures of Effect Measures of Exposure

birds, reptiles and terrestrial

- phase amphibians Bobwhite quail/ mallard duck acute oral LD 50 Bobwhite quail/ mallard duck sub

- acute dietary

LC 50 Bobwhite quail/ mallard duck chronic reproduction NOAEC and LOAEC Maximum

residues on food items (foliar) Survival, reproduction, and growth of individuals and populations of mammals Laboratory rat acute oral LD 50 Laboratory rat 2

- generation NOAEC and

LOAEC Freshwater fish and aquatic

- phase amphibian

- individuals and communities . Acute Fish

- Rainbow trout and bluegill sunfish

LC 50 Chronic

- Freshwater Fish NOAEC and LOAEC

with Fathead minnow Peak EEC

60

- day average

EEC

Freshwater invertebrate( individuals and communities) Acute

- Daphnid EC 50 Peak EEC

Chronic

- Daphnid life cycle NOAEC and

LOAEC 21

- day average

EEC

Estuarine/marine fish and estuarine/marine

invertebrate

- individuals or communities Acute Fish: Sheepshead minnow acute LC 50 Acute Mollusc:Eastern oyster EC 50 Acute Crustacean: Mysid LC 50 Peak EEC

Chronic Fish Sheepshead NOAEC/LOAEC Chronic Crustacean:Mysid NOAEC/LOAEC 60

- day average

EEC

21

- day average

EEC

Survival of beneficial insect populations Honeybee acute contact LD 50 Hazard assessment only Maintenance and growth of individuals and populations of terrestrial plants from standing crop or biomass Monocot EC 25 and NOAEC values for seedling emergence and vegetative vigor (survival and growth rate)

Dicot EC 25 and NOAEC values for seedling emergence and vegetative vigor (survival and growth rate) Estimates of runoff and spray

drift to non

- target

areas

Maintenance and growth of individuals and populations of aquatic plants from standing crop or biomass Vascular plant EC 50 and NOAEC values for growth rate and biomass measurements

Non

- vascular plant EC 50 and NOAE C values for growth rate and biomass measurements Peak EEC



### 2.6.2 Data Gaps

Environmental Fate Data Requirements

With the exception of aerobic aquatic metabolism, only one soil or sediment system was

included in each of the metabolism studies. In the absence of additional studies to better quantify the range in metabolism rates, EFED is multiplying the half

- lives by 3X to provide a potential upper bound on the expected range in average metabolism half lives . According to the proposed labels, t olfenpyr ad can be used over numerous crops as described in Table 1.1 . ThePage 18 of 125



### registrant should submit additional aerobic soil meta bolism studies in which soil are collected from the proposed use areas.

The submitted fish bioconcentration study neither measured tolfenpyrad nor identified degradates in fish tissues, but shows a potential for bioconcentration of these chemicals (BCF = 4,168 L/kg w.w. in whole fish) based on total radioactive residues in fish tissue and water. Although any in vivo biotransformation of tolfenpyrad by fish would result in less parent material in fish tissue (and a lower BCF based on parent chemical), metabolism of the chemical in the exposure water would lead to a higher BCF based on parent chemical in water). Therefore, given the bi oaccumulation potential of tolfenpyrad in combination with its persistence and proposed use patterns, a new BCF study in which residues of parent chemical and metabolites are measured should be submitted to the Agency.

Table 2.3. Environmental Fate Data Requirement for Tolfenpyrad.

Study Title Guideline MRID Study

Classification Additional Data Needed?

Hydrolysis 835.2120 47447713 Acceptable No

Photodegradation in

Water 835.2240 47463701 Acceptable No

Photodegradation on Soil 835.2410 47447715 Acceptable No

Photodegradation in Air 835.2370

--- Waived No

Aerobic Soil Metabolism 835.4100 47447716

48250406 (amended report

from 47447716) Acceptable Yes. Studies using three

additional soils are needed.

Anaerobic Soil

Metabolism 835.4200 48250407 Acceptable No

Aerobic Aquatic

Metabolism 835.4300 48250408

48953811 Acceptable No

Anaerobic Aquatic

Metabolism 835.4400 48250409 Acceptable No

Mobility

- Adsorption/Desorption 835.1230 47447712 (parent) 48250404 (PCA

and PT

- CA) Acceptable

Acceptable for

PT

- CA study Supplemental for PCA study No

Terrestrial Field Dissipation (CA, FL, WA, MI) 835.6100 48250410 Acceptable NoPage 19 of 125

Study Title Guideline MRID Study

Classification Additional Data Needed?

Fish Bioconcentration 850.1730 48250424 Supplemental Yes. A study in which parent and its degradates

are identified and quantified is needed.

ECM/ILV in soil 835.6100

850.7100 48250454

Analytical

method in soil and storage stability analysis (parent, PCA,

and PT

- CA) Acceptable

No

48250456 Analytical method (ILV) in soil (parent, PCA, and PT

CA) Acceptable

47447727 Laboratory method analysis in soil (parent, PCA, and PT

CA) Acceptable

ECM/ILV in water 850.7100 48250443 (parent) Acceptable No



### Ecological Effects Data Gaps

A summary of the submitted data and justification for additional data needed to fill ecological toxicity data gaps considered of high value to the risk assessment is provided in Table 2.4

.

Table 2. 4 Ecotoxicity Data Requirements

Study Title Guideline MRID (s) Study

Classification Additional Data Needed?

Avian oral toxicity 850.2100 48250426 Supplemental No. The acute oral study for passerine species is supplemental due to treatment

related regurgitation . The E D 50 us ed for

risk assessment was set based on regurgitation response, but no mortality or body weight changes occurred in birds regardless of regurgitation

. Therefore, the

ED 50 is considered conservative. Furthermore, the oral LD 50 for bobwhite quail (87 mg ai /kg bw) is close to the passerine ED 50 (58 mg ai/kg bw); therefore, a substantial increase in the passerine LD 50 above the current ED 50 would not affect the risk conclusions 47447722 AcceptablePage 20 of 125



### Study Title Guideline MRID (s) Study

Classification Additional Data Needed?

because the bobwhite quail LD 50 would be

used for risk estimation.

Avian dietary toxicity 850.2200 47447723 Acceptable No

48250427 Acceptable

Avian reproduction 850.2300 48250428

48250429 Supplemental Yes

, a definitive NOAE L was not
established in the available chronic avian

t oxicity studies conducted with

T olfenpyrad. 48250430

48250431 Supplemental

Honeybee acute contact toxicity 850.3020 48250432 Acceptable No

Honeybee toxicity of residues on foliage 850.3030 48250433 Supplemental No. T he submitted toxicity of residues on foliage study for honey bees was classified as supplemental because an RT 25 could not be determined. The mortality response observed in the study did not follow a

dose

- response pattern (40%, 13% and 20% at 8, 24 and 48 hours, respectively).

At 48 hours (test termination), mortality was high (20%) compared to the control mortality (5%). Therefore, the RT 25 is likely between 8 and 48 hours

. Field Testing for

Pollinators 850.3040 Yes, pending pollinator risk mitigation

measures.

Freshwater fish

–

a cute toxicity 850.1075 47447721 Acceptable No.

48250415 Supplemental

48250413 Acceptable

48250416 Supplemental

474477 19 Supplemental

47447720 Supplemental

4825041 7 Supplemental

Saltwater fish

–

a cute toxicity 850.1075 48250414 Acceptable No.

Freshwater

invertebrates

–

a cute toxicity 850.1010 47490701 Acceptable No. One study was submitted that

examine d tolfenpyrad end

- use product toxicity to freshwater invertebrates , but considered supplemental as concentrations

were not measured

. 47447718

with 15

EC Supplemental

Saltwater invertebrates

– a cute toxicity 850.1025

850.1035 48250412 Supplemental No. A definitive LC 50 could not be calculated for the saltwater mysid or eastern oyster, due to lack of effects at the highest treatment level. However, t he peak

modeled surface water concentrations did

not exceed the highest concentration tested

in th ese stud ies 48250411 Supplemental

freshwater invertebrate life cycle test 850.1300 48250418 Acceptable No

.Page 21 of 125



### Study Title Guideline MRID (s) Study

Classification Additional Data Needed?

Saltwater

invertebrates

– life cycle test 850.1350 48250420 Supplemental No. T he available study used a total radioactive residues to quantify tolfenpyrad exposure (the radioactivity was not assigned to either the parent compound or degradates)

. However, degradates are not considered of toxicological concern to aquatic organisms.

Freshwater fish

– early life stage test

/life cycle test 850.1400

850.1500 48250422

48250423 Supplemental

Supplemental No

. Growth results from ELS test not

considered reliable; Results from fish full life cycle study considered supplemental

due to use of total radioactive residues instead of parent chemical

Saltwater fish

– early life stage test

/life cycle test 850.1400

850.1500 48250421 Supplemental No

. T he available study used a total radioactive residues to quantify tolfenpyrad exposure (the radioactivity was not assigned to either the parent compound or degradates). Howev er, degradates are not considered of toxicological concern to aquatic organisms.

Whole sediment toxicity test, freshwater

invertebrates

Whole sediment toxicity test, saltwater

invertebrates 48250425 Supplemental Yes. Although the LOAEC from this study was greater than the highest test concentration, t he predicted pore water exposure concentrations exceed the highest pore water concentration in th is study. The high partitioning, toxicity and persistence of tolfenpyrad indicate that chronic (life cycle) s ediment toxicity data

are needed to assess risks to benthic aquatic invertebrates.

Terrestrial Plant toxicity: Tier s I/ II seedling emergence 850.4225 48250434 Supplemental No.

Terrestrial Plant toxicity: Tier s I/ II vegetative vigor 850.4250 48250435 Acceptable No

.

Aquatic Plant Growth: algae 850. 5400 47447725 Acceptable No

48250437 Supplemental

47447726 Supplemental

48250441 Supplemental

48250438 Supplemental

48250439 Supplemental

48250440 Supplemental

Aquatic Plant Growth: vascular plants 850.4400 48250436 Supplemental No. The submitted tolfenpyrad toxicity study with the aquatic vascular plant species Lemna gibba did not allow

calculation of a definitive EC 50 . However,Page 22 of 125



### Study Title Guideline MRID (s) Study

Classification Additional Data Needed?

no risk concerns were expected to this taxon using a more conservative estimate of toxicity, the available NOAEC from this study. Therefore, no additional data is requested at this time

Freshwater

I nvertebrate life cycle test 850.1300 48250418 Acceptable No

.

Saltwater

invertebrates

– life cycle test 850.1350 48250420 Supplemental No. T he available study used a TRR to quantify tolfenpyrad exposure (the radioactivity was not assigned to either the parent compound or degradates ). However, the degradates are not considered of toxicological concern to

aqu atic organisms.



## 3 .0 Exposure Analysis

3.1 Use characterization

See Section 2.3 for an overview of the proposed pesticide usage for this new use assessment.

3. 2 Environmental Fate and Transport Characterization

Based on the submitted environmental fate data and reported physical

- chemical properties, tolfenpyrad and its transformation products are expected to undergo moderate degrad ation in the

environment. Tolfenpyrad has the potential to contaminate surface wat er via spray drift and

runoff of residues sorbed to sediment. Since tolfenpyrad is currently proposed for use on many crops, deposition off

- field or into surface water via spray drift is likely.

In the laboratory, tolfenpyrad degraded to PAM, PCA, PT(A )

- 4OH, PT

- CA, PT

- CHO, PT

- OH,

OH

- PAM, and OH

- PT

- OH in aqueous photolysis (linear half

- life = 23.6 days, 12 hour light/dark cycle), soil photolysis (linear half

- life = 48.1 days, 12 hour light/dark cycle), aerobic soil (nonlinear half

- life = 15.1 days and IO R), anaerobic soil (nonlinear half

- life = 216.6 days), aerobic aquatic (nonlinear half

- life, total system = 14.5 days and IORE half

- life, total system = 5.1 days), and anaerobic aquatic (nonlinear half

- life, total system = 385.1 days) conditions. Tolfenpy rad was essentially stable under laboratory hydrolysis conditions. Under terrestrial field conditions, tolfenpyrad degraded to PCA and PT

- CA (tolfenpyrad nonlinear half

- lives = 1.8

- 6.6 days). PCA and PT

- CA are expected to be mobile ( K OC 

### values of 12.5 an d 19 mg/L, respectively)

.

In an aerobic sandy loam soil environment in the laboratory, 20.7

- 51.7% of the applied tolfenpyrad was present at 21 days, decreasing to 1.6

- 2.8% at 365 days. In an anaerobic sandy loam soil environment in the laboratory, 27.7

- 54.4% of the applied was present almost exclusively in the soil at 44 days post

- treatment (30

- 31 days post

- flooding), decreasing to 11.6

-Page 23 of 125



### 51.3% at 135

- 136 days post

- treatment (122 days post

- flooding). In an aerobic aquatic pond

water

- sandy loam sediment en vironment, 14.1

- 23.5% of the applied was present only in the sediment at 30 days, decreasing to 4.1

- 7.2% at 101 days post

- treatment. In an aerobic aquatic

lake water

- sand sediment environment, tolfenpyrad in the water column decreased from 90.1

- 100.5% of the applied at day 0 to 1.6

- 4.9% at 7 days and was not detected thereafter, while tolfenpyrad in the sediment increased from 7.0

- 9.4% of the applied at day 0 to a maximum 60.4% at 3 days and was 1.5

- 1.9% at 100 days. In an anaerobic aquatic pond water

- loam sediment environment in the laboratory, 71.2% of the applied was present in the sediment only at 33 days, decreasing to 48.9% at 367 days post

- treatment. Tolfenpyrad is essentially stable to hydrolysis with 90.3

- 93.7% of the applied remaining after 31 da ys at pH 5, 7, and 9. Under field conditions it appears that a combination of processes takes place and that this chemical dissipates faster in the field than predicted by the available laboratory studies. Tolfenpyrad degrades and dissipates quickly and was detected up to 59 days in sand soil and not detected after 30, 7 and 31 days in loam, sandy loam and loamy sand soils, respectively.

In soil, tolfenpyrad is expected to be hardly mobile. In four soils (sandy clay loam, sandy loam, clay loam and loamy sand), the adsorption soil

- water partition coefficients (K d 

### ) were 123

- 1,101 mg/L, and the organic carbon partition coefficients ( K OC 

### ) were 18,882

- 40,364 mg/K g oc 

### in the

four soils with organic matter contents of 0.7

- 6.8% and pHs of 5.6

- 7.9 . The octanol

- water partition coefficient (log K OW 

### ) of tolfenpyrad was 4.3 (MRID 47447701). However, another much higher K OW 

### of tolfenpyrad (log K OW 

### 5.61) was reported in a field dissipation study (MRID 48250410). As requested, the registrant had submitted this study to OPP in 2012 (MRID 48953811).

Tolfenpyrad moderately degrades under aerobic conditions (half

- lives of 14

- 15 days in aerobic soil and aerobic aquatic water

- sediment systems, and dissipation half

- lives of 1.8

- 6.6 days under terrestrial field conditions). Under anaerobic conditions, tolfenpyrad is considerably more persistent (half

- life 216.6 days in anaerobic soil and 385.1 days in anaerobic aquatic water

se diment system). The compound is relatively involatile (vapor pressure 3 x 10 - 7 

### mmHg) and essentially hardly mobile in soil. Therefore, it is not expected to leach to ground water. Due to

the low K OC 

### values, PCA and PT

- CA may leach to ground water.

Tolfenpyrad degrades to PT(A)

- 4OH; and via cleavage of the tolyloxy group at the N

- C bond to PAM, which is oxidized to PCA; and via oxidation of the terminal methyl group of the tolyloxy ring to form PT

- OH, which is further oxidized to PT

- CHO and PT

- CA (se e Appendix B for the proposed metabolism pathway). Tolfenpyrad ultimately degrades to CO 2 

### and bound residues

under all conditions. Table 3.1 summarizes the chemical and environmental fate data for tolfenpyrad. These were derived from information submitte d under environmental fate guidelines. Hydrolysis, aqueous and soil photolysis, aerobic and anaerobic soil metabolism, aerobic and anaerobic aquatic metabolism, adsorption

- desorption and terrestrial field dissipation studies were conducted with tolfenpyra d.Page 24 of 125



### Table 3.1. Summary of physical/chemical and environmental fate and transport properties of tolfenpyrad and its transformation products.

Parameter Value (S) (units) MRID Comment A

Chemical Name Tolfenpyrad:

IUPAC: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [4

- ( p

tolyloxy)benzyl]pyrazole

- 5

- carboxamide.

CAS: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [[4

- (4

- methylphenoxy)phenyl]methyl]

- 1 H

- pyrazole

- 5

-

carboxamide.

PAM : IUPAC: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

pyrazole

- 5

- carboxamide.

PT

- CA (Tolfenpyrad

- PT

- CA):

4

- [4

- ({[(4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

- pyrazol

5

- yl)carbonyl]amino}methyl)phenoxy]benzoic

acid

.

OH

- PAM:

4

- Chloro

- 3

- (1

- hydroxyethyl)

- 1

- methyl

- 1H

pyrazole

- 5

- carboxamide

.

PT

- OH:

4

- Chloro

- 3

- ethyl

- N

- {4

- [4

- (hydroxymethyl)phenoxy]benzyl}

- 1

- methyl

- 1H

pyrazole

- 5

- carboxamide.

PT

- CHO:

4

- Chloro

- 3

- ethyl

- N

- [4

- (4

- formylphenoxy)benzyl]

- 1

- methyl

- 1H

- pyrazole

5

- carboxamide.

PCA (Tolfenpyrad

- PCA):

4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

- pyrazole

- 5

-

carboxylic acid.

PT(A)

- 4OH (PT(A)

- 4

- OH):

4

- Chloro

- 3

- ethyl

- N

- (4

- hydroxybenzyl)

- 1

- methyl

- 1H

- pyrazole

- 5

- carboxamide. Product chemistry –

Molecular Weight Tolfenpyrad: 385.7 g/mole

PT

- CA: 413.9 g/mole PCA: 118.6 g/mole Product chemistry –

Solubility (25 o C) Tolfenpyrad: 0.087 mg/L in water 6.92 g/L in n

- heptane 218 g/L in xylene >250 g/L in 1,2

- dichloroethane 50.8 g/L in methanol 43.7 g/L in n

- octanol 250 g/L in acetone and ethyl acetate 368 g/L in acetone Product chemistry -

Vapor Pressure (25 o C) Tolfenpyrad:

3 x 10 - 7 mmHg Product chemistry –Page 25 of 125



### Parameter Value (S) (units) MRID Comment A

Henry’s Law Constant (25 o C) 1.7x10 - 6 atm•m 3 •mol

- 1 Product chemistry Estimated from water

solubility and vapor

pressure pKa

– – –

Octanol

- Water

Partition Coefficient
(log 

### K OW , 25 o C) Tolfenpyrad:

4.3

5 .61 4744770 5

48250410

48747601 -

pH not reported

-

Hydrolysis Half

Life (25 o C) pH 5 pH 7 pH 9 Tolfenpyrad:

t 1/2 = 3,465 days

t 1/2 = 693.1 days

Stable 47447713 Pyrazole label. At pH 5 and 7, the half

- lives were extrapolated beyond the duration of the study.

Aqueous Photolysis Half

- life (pH 7 buffer, 25 o C) Tolfenpyrad:

t 1/2 = 9.6 days (combined labels; continuous

irradiation)

or

t 1/2 = 23.6 days (combined labels; environmental

12 hour light/dark cycle) 47463701 Pyrazole and tolyloxy

labels. Tolfenpyrad was stable in dark controls

Soil Photolysis

Half

- life (25 o C) Tolfenpyrad:

t 1/2 = 22.2 days (combined labels; continuous

irradiation)

or

t 1/2 = 48.1 days (combined labels; environmental

12 hour light/dark cycle) 47447715 Pyrazole and tolyloxy labels. Tolfenpyrad was stable in the pyrazole label control, and declined in the tolyloxy label

.

Aerobic Soil

Metabolism

Half

- life (25 o C, 75% of 1/3 bar) Tolfenpyrad:

t 1/2 = 15.1 days (combined labels; non

- linear). 474 47716

48250406 Pyrazole and tolyloxy

labels. Sandy loam soil

from California.

Anaerobic Soil

Metabolism Tolfenpyrad:

t 1/2 = 216.6 days (combined labels; total system,

non

- linear). 48250407 Pyrazole and tolyloxy labels. Sandy loam soil

from California. Aerobic Aquatic

Metabolism Tolfenpyrad:

t 1/2 = 14.5 days (combined labels; total system,

non

- linear).

t 1/2 = 5.5 days (combined labels; total system,

non

- linear). 48250408

4895 3811 Pyrazole and tolyloxy

labels. Pond water

- sandy

loam sediment from

California.

Pyrazole and tolyloxy

labels. Pond water

- sandy

sediment from North

Dakoda. Anaerobic Aquatic

Metabolism Tolfenpyrad:

t 1/2 = 385.1 days (pyrazole label; total system,

non

- linear). 48250409 Pyrazole labels. Pond

water

- loam sediment from

California. Adsorption Tolfenpyrad 

### K OC = 29,380 L/kg OC

(mean of 18882, 40364, 27525, and 30750)

PT

- CA 

### K OC = 19 L/Kg OC
PCA 

### K OC = 12.5 L/Kg OC 47447712

48250404 Two soils (clay loam and

sandy loam) for PCA study. Four soils (clay loam, two sandy loam, and sandy clay loam) for

PT

- CA studyPage 26 of 125



### Parameter Value (S) (units) MRID Comment A

Terrestrial Field Dissipation Tolfenpyrad:

t 1/2 = 1.8

- 6.6 days (four soils, non

- linear). 48250410 Sand soil from Florida, loam soil from Michigan, sandy loam from California, and loamy soil from Washington

Fish

Bioconcentration Maximum BCFs in two test concentrations (0.015 and 0.045 ppm): BCF in edible = 2,119x and 1,973x BCF in nonedible = 6,948x an d 7,227x BCF in whole fish = 4,167x and 4,168x 482504 24 Pyrazole labels. Well

water from MD was used. Bluegill was used.



### Studies conducted with both pyrazole and tolyloxy radiolabels include: aqueous photolysis, soil photolysis, aerobic and anaerobic soil metabolism, and aerobic and anaerobic aquatic metabolism. Studies conducted with pyrazole radiolabel only include hydrol ysis, adsorption

desorption, and fish bioconcentration.

3.2.1 Fate in water

Tolfenpyrad may enter surface water through spray drift when applied using a ground spray or aerial spray in an open air environment (currently approved for greenhouse use only), or in particularly adverse conditions through runoff of sediment bound residues (erosion ) from agricultural fields. If it does reach surface water, tolfenpyrad is expected to be slow to degrade
to PAM, PT

- CA, PT

- OH, and PT

- CHO under ideal conditions for photodegradation. In the absence of sunlight, tolfenpyrad is stable to hydrolysis. Being hardly mobile, tolfenpyrad is not expected to leach to ground water. Due to the low K OC 

### values , PCA and PT

- CA may leach to ground water.

3.2.2 Fate in air

Based on its low vapor pressure (4 x 10 - 5 

### Pa at 25°C), tolfenpyrad is not likely to partition sign ificantly to air. Volatile products other than CO 2 

### were not detected in volatile traps in the laboratory studies; the majority of the applied radioactivity was recovered in the soil. At environmentally relevant pH ranges, tolfenpyrad is not likely to vap orize from soil or water at a significant level. Some movement of bound residues on wind

- borne soil particles is a possibility. However, long

- range transport in air is not likely to be a dissipation route of concern for tolfenpyrad.

3.2.3 F ield S tudies

Four terrestrial field dissipation studies for tolfenpyrad were provided. Half

- lives ranged from

1.8

- 6.6 days. PT

- CA and PCA were detected 0

- 15 cm soil depths. PCA was also detected 15

- 30 cm soil depths.Page 27 of 125



### 3.2.4 B ioconcentration Studies

A bioconcentration in fish study for tolfenpyrad was provided. The test species was bluegill sunfish. However fish samples and exposure water were analyzed for t otal radioactive residues only and concentrations of tolfenpyrad in the fish samples and expo sure water were not determined. However, tolfenpyrad is stable to hydrolysis and under laboratory aqueous photolysis (12 hour light/dark cycle) has a half

- life of 23.6 days, therefore, the radioactive residues present in the exposure water are likely to b e tolfenpyrad. Steady

- state BCF values

were 1

, 577 for edible tissues, 4

, 959 for nonedible tissues, and 3

, 008 for whole fish tissues for

total residues. Maximum BCF values were 1

, 973 (28 days) for edible tissues, 7,227 (28 days) for nonedible tissues, and 4,168 (28 days) for whole fish tissues, based on total residues. Uptake rate constants (k 1 

### ) were 294, 1

, 243, and 680 days - 1 

### and depuration rate constants (k 2 

### ) were 0.209, 0.235, and 0.224 days - 1 

### for edible, nonedible, and whole fish tissues, respectively.

3.2.5 Fate Properties of Transformation Products

The major transformation products (formed in amounts greater than or equal to 10% of applied radioactivity) resulting from the degradation of tolfenpyrad are: PAM (aqueous and soil photolysis, aerobic aqu atic metabolism), PCA (tolfenpyrad

- PCA; aerobic soil and aerobic aquatic metabolism and terrestrial field dissipation), PT

- OH (aqueous photolysis), PT

- CHO (aqueous photolysis), PT(A)

- 4OH (anaerobic soil) and PT

- CA (tolfenpyrad PT

- CA; soil photolysis, aerob ic and anaerobic soil metabolism, aerobic and anaerobic aquatic metabolism and terrestrial field dissipation ) ( Table 3. 2 ). Although some of the degradates described above as major degradates detected in some studies, some of these major degradates could b e detected as minor degradates in other studies. In addition, two minor degradates were detected (see Appendix A for minor degradates and the chemical structures for all identified degradates)

.

The identified minor transformation products (formed in amou nts less than 10% of applied radioactivity) resulting from degradation of tolfenpyrad under laboratory conditions are: PAM (aqueous and soil photolysis, dark control, aerobic and anaerobic soil, and anaerobic aquatic),

PT

- OH (aqueous and soil photolysis, aerobic soil), PT

- CHO (soil photolysis), PT

- CA (aqueous and soil photolysis), OH

- PAM (soil photolysis), PCA (anaerobic soil and anaerobic aquatic),

OH

- PT

- OH (anaerobic soil and aerobic aquatic water

- sediment) and PT(A)

- 4OH (a erobic soil and anaerobic aquatic) ( Table 3.9 ).

The degradates PCA and PT

- CA are expected to be highly mobile. For PCA in two soils (clay loam and sandy loam) and PT

- CA in four soils (clay loam, sandy loam, sandy loam, and sandy clay loam), the adsorpt ion soil

- water partition coefficients (K d 

### ) were 0.11

- 0.49 and 0.01

- 2.00 mg/L, respectively. The octanol

- water partition coefficient (log K OW 

### ) and pH of PCA and PT

CA were not reported. The Freundlich adsorption coefficients ( K OC 

### ) of PCA were 6

- 9 (PT

- CA

n ot determined) in two soils with organic matter contents of 1.9

- 5.6% and pHs of 5.5

- 5.7 (1:1, soil:water ratio). PCA and PT

- CA are classified as highly mobile (FAO 2000).Page 28 of 125



### Table 3.2. Summary of major degradate formation from degradation of Tolfenpyrad.

STUDY TYPE MAJOR DEGRADATE and MAXIMUM CONCENTRATION SOURCE

MRID PAM (% applied) PT

- CA (%

applied) PCA (% applied) PT

- CHO (% applied) PT

- OH (%

applied) PT(A)

- 4OH (%

applied)

Batch Equilibrium – –

– – – – –

Hydrolysis

– –

– – – – 47447713

Aqueous Photolysis 10.8% at 307.5

hours (irradiated pyrazole label) – – 9.7% at 102 hours (irradiated pyrazole label)

10% at 143 hours (irradiated tolyloxy label) 9.3% at 318 hours

(7.1% and 11.5% in the replicates ;irradiated tolyloxy label) – 47463701

Soil Photolysis 11.3% at 310.3

hours (irradiated pyrazole label) 13% at 313.5

hours (irradiated tolyloxy label) – – – – 47447715

Aerobic Soil

Metabolism – 36.9% at 30 days (tolyloxy label) 34% at 63 days

(pyrazole label)

– – – 47447716

48250406

Anaerobic Soil

Metabolism – 41.6% at 44 days, total system (pyrazole label) – – – 20.4% at 136 days, total system, (pyrazole label) 48250407

Anaerobic Aquatic

Metabolism – 18.0% at 90 days, total system (pyrazole label) – – – – 48250409

Aerobic Aquatic

Metabolism 11.8% at 30 days,

total system (pyrazole label) 50.1% at 30 days,

total system (tolyloxy label) 48.9% at 101

days, total system (pyrazole label) – – – 48250408

Aerobic Aquatic

Metabolism 16.1% at 30 days,

total system (pyrazole label) 50.3% at 7 days,

total system (pyrazole label) 64.3% at 100

days, total system (pyrazole label) - - - 48953811

Terrestrial Field Dissipation – detected at 14 days in loamy

sand soil detected at 13

days in sandy

loam soil – – – 4825410

Studies conducted with both pyrazole and tolyloxy radiolabels include: aqueous photolysis, soil photolysis, aerobic and anaer obic soil metabolism, aerobic and anaerobic aquatic metabolism and terrestrial field dissipation. Studies conducted with pyrazole radiolabel only include hydrolysis and adsorption

- desorption. The non

- guideline analytical methods study was not radiolabelled.



### Tolfenpyrad degrades to PAM (see the aerobic soil metabolism pathway in Appendix B ) via cleavage of the tolyloxy group at the N

- C bond. PAM is formed at maximums of 10.8% of applied in aqueous photolysis, 11.3% in soil photolysis, and 11.8% in aerobic aquatic metabolism. PAM further oxidizes to PCA at a maximum of 34.0% of applied in aerobic soil, 48.9% in aerobic aquatic water

- sediment, and 19.8% in terrestrial field dissipation study. Tolfenpyrad also degrades via oxidation of the terminal methyl group of the tolyloxy ring to

form PT

- OH at a maximum average of 9.3% of applied in aq ueous photolysis, which is further

oxidized to PT

- CHO at a maximum of 10.0% of applied in aqueous photolysis and PT

- CA at maximums of 13.0% of applied in soil photolysis, 36.9% of applied in aerobic soil, 41.6% in anaerobic soil (total system), 50.1% in a erobic aquatic water

- sediment (total system), 18.0% in anaerobic aquatic water

- sediment (total system), and 26.6% in terrestrial field dissipation study. PT(A)

- 4(OH) is also formed via hydrolytic cleavage of the phenyl group in the tolyloxy moietyPage 29 of 125



### at maxim ums of 20.4% in anaerobic soil (total system), and 7.8% in anaerobic aquatic water

sediment (total system). Tolfenpyrad ultimately degrades to CO 2 

### and transforms to bound

residues.

The degradation of tolfenpyrad to PAM, and also to PT

- OH and PT

- CHO, via aqueous photolysis is only likely to be significant in clear, shallow water. In actual environmental systems, aqueous photolysis is likely to proceed at a much slower rate due to the attenuation of light due to increasing depth of water bodies, light adso rption by suspended solids, and natural obstruction of sunlight. The remaining minor transformation products, OH

- PAM and PT(A)

- 4OH, are not expected to form in high concentrations in the environment.

Major Degradates

Major environmental degradates of a compound may be of exposure concern for surface water. The major transformation products resulting from the degradation of tolfenpyrad are: PAM, PCA, PT

- OH, PT

- CHO, PT(A)

- 4OH and PT

- CA. Of these six major degradates, EFED is more concerned about PCA, PT

- CA, PT(A)

- 4OH, and PAM due to their high residue levels and

because PT

- CHO and PT

- OH were only formed via aqueous photolysis, which is not likely to be the dominant route of degradation. These degradates of exposure concern were identified to help

the ROCK S determine which of them are of risk (rather than exposure) concern. At the ROCKS meeting, the team decided to include tolfenpyrad and its four major degradates (PCA, PT

- CA, PT(A)

- 4OH, and PAM) as residues of concern in drinking water due to the lack of toxicity information. Total residues approach was used to estimate exposure to the tolfenpyrad residues of concern in drinking water. This approach involves the use of total

- residues degradation half

lives based on the sum of residues of concern at each sampling interval in submitted laboratory degradation studies. Also, the chemical properties and soil mobility of the residue of concern most vulnerable to environmental transport are typically used to represent the chemical properties and soil mobility of all residues.

After the completion of the 2012 Tofenpyrad Ecological Risk Assessment ( D383821) , the registrant submitted additional rainbow trout toxicity studies. These studies produced toxicity values over 4000 times lower than the parent for this species. Based on the findings in these studies, EFED has decided to use parent compound only in modeling in the current ecological

risk assessment.

3. 3 Aquatic Exposure Estimates

The Tier II models, Pesticide Root Zone Model (PRZM v3.12.2, May 12, 2005) linked with EXposure Analysis Modeling System (EXAMS v2.98.04.06, Apr. 25, 2005) via the PE model shell (PE v5.0, Nov. 15, 2006, i.e. , PRZM/EXAMS) were run to estimate screening

- lev el exposure of surface water sources to tolfenpyrad residues following the proposed uses. For those crops required a buffer zone of 150 feet in aerial application, AGDRIFT was used to estimate the spray drift prior to PRZM/EXAMS.

The PE model generates EECs of tolfenpyrad residues that may occur in surface water down gradient from applications on terrestrial crops. The PRZM model simulates pesticide movementPage 30 of 125



### and transformation from crop application through soil residue processes. The EXAMS model

simula tes pesticide loading via runoff, erosion, and spray drift assuming a standard watershed of 172.8 ha that drains into an adjacent pond. EXAMS (PE) model and associated users manuals may be downloaded from the U.S. Environmental Protection Agency (EPA) Wat er Models web

page ( http://www.epa.gov/oppefed1/models/water/index.htm ).

3.3.1 Modeled Exposure in Surface Water and Pore Water

In order to assess the impact of the use of tolfenpyrad on t he resulting EECs, the application inputs for representative food use in modeling were selected ( Table 3. 3 ). Since only one aerobic soil metabolism study and one anaerobic aquatic metabolism study were s u bmitted, the

metabolic half

- lives used in modeling were timed by 3.

Table 3. 3 . PRZM/EXAMS Chemical Input Parameters for Tolfenpyrad.

Input Parameter Value Justification Source

Molecular Weight (g/mol) 385.7

- Product Chemistry

Solubility in Water (mg/L) 0.087

- Product Chemistry

Vapor Pressure ( mmHg) 3 x 10 - 7

- Product Chemistry

Hydrolysis Half

- life at pH 7 (days) 693

- 47447713

Aqueous Photolysis

Half

- life (days) 25.6 Linear half

- life 47447715

Organic Carbon Partition Coefficient (L/kg) 29,380 Mean of 18,882, 40,364, 27,525, and 30,750 47447712

Aerobic Soil Metabolism

Half

- life (days) 45.3 (15.1x3) Non

- linear half

- life 47447716

48250406

Aerobic Aquatic Metabolism

Half

- life (days) 24.3 Non

- linear half

- life 48250408

48952801

Anaerobic Aquatic

Metabolism Half

- life (days) 1,155.3

(385.1x3) Non

- linear half

- life 48250409



### Th e current ecological risk assessment is based on tolfenpyrad. Based on the revised labels (such as including a 150

- ft buffer zone for aerial application, additional modeling was performed using the same approa ch on all representative food uses as well as all application methods.

Tables 3. 4 and 3. 5 showed EECs in surface water and pore water, respectively. Tolfenpyrad was modeled in this assessment as relatively persistent because of limited number of aerobi c soil and anaerobic aquatic metabolism studies are available. If additional fate studies are available, EECs could be refined and would likely result in lower values.

Table 3. 4

. EECs (μg a.i. /L) for surface water based on tolfenpyrad use patterns, application methods (aerial, ground, and airblast equipment)

Scenario* Peak EEC 21

- Day EEC 60

- Day EEC Aerial Application

CA citrus 0.21 0.07 0.05Page 31 of 125

Scenario* Peak EEC 21

- Day EEC 60

- Day EEC

FL citrus 0.78 0.26 0.22

TX cotton 2.68 0.67 0.47

CA cotton 0.20 0.08 0.02

CA tomatoes 0.17 0.17 0.04

CA lettuce 0.11 0.11 0.08 Fl cabbage 0.79 0.04 0.02 ID potato 0.31 0.11 0.09 Airblast Application NC apple 1.62 0.55 0.41 PA apple 1.24 0.47 0.41 OR apple 0.85 0.36 0.28

CA citrus 0.48 0.15 0.01

FL citrus 0.19 0.32 0.28 GA peach 0.14 0.32 0.22

GA Pecans 1.44 0.40 0.31



### Ground Boom, Air Curtain Sprayers or other application method

MS Cotton 2.80 0.88 0.67

FL cucumber 0.55 0.18 0.15

CA Tomato 0.13 0.04 0.03 CA Grapes 0.17 0.06 0.04 FL Cabbage 0.78 0.11 0.13

CA Lettuce 0.21 0.09 0.08 ID potato 0.30 0.10 0.08

* See Table 2.2 for application rate information and Table 3.3 for input parameters used to generate the aquatic

EECs. Aquatic EECs for all aerial applications except potato include a 150 ft spray drift buffer per the proposed

label.



### Table 3.5

. EECs (μg a.i. /L) for Pore Water Based on Tolfenpyrad Use patterns, Application Methods (aerial, ground, and airblast equipment)

Scenario* Peak EEC 21

- Day EEC 60

- Day EEC Aerial Application

CA citrus 0.03 0.03 0.03

FL citrus 0.16 0.16 0.16

TX cotton 0.31 0.31 0.31

CA cotton 0.04 0.04 0.04

CA tomatoes 0.03 0.02 0.02

CA lettuce 0.06 0.06 0.06 Fl cabbage 0.01 0.01 0.01 ID potato 0.06 0.06 0.06 Airblast Application NC apple 0.29 0.29 0.28 PA apple 0.29 0.29 0.28 OR apple 0.20 0.20 0.20

CA citrus 0.06 0.06 0.06

FL citrus 0.19 0.19 0.19 GA peach 0.14 0.14 0.14

GA Pecans 0.22 0.22 0.21 CA Grapes 0.07 0.07 0.07

Ground Application Ground Boom, Air Curtain or other methodPage 32 of 125

Scenario* Peak EEC 21

- Day EEC 60

- Day EEC

MS Cotton 0.50 0.49 0.48

FL cucumber 0.10 0.10 0.10

CA Tomato 0.02 0.02 0.02 FL Cabbage 0.09 0.09 0.09

CA Lettuce 0.01 0.01 0.01 ID potato 0.06 0.06 0.06 CA Grapes 0.03 0.03 0.02

* See Table 2.2 for application rate information and Table 3.3 for input parameters used to generate the pore water

EECs. Aquatic EECs for all aerial applications except potato include a 150 ft spray drift buffer per the proposed

label.



### 3.3.2 Aquatic Exposure Monitoring and Field Data

No national

- scale monitoring data were available for this chemical in the United States . Though indoor greenhouse use is approved no outdoor uses have been registered to date

.

3. 4 Terrestrial Wildlife Exposure Estimates

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals emphasizing uptake of pesticide residues on contaminated vegetative matter and insects as dietary items. Pesticide residues on food items are estimated based on the assu mption that organisms are exposed to a single pesticide residue in a given exposure scenario. The residue estimates from spray applications are based on extensive crop/residue research and the resulting nomogram by Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994). The research correlated residue levels on various terrestrial plant and insect surfaces immediately following application at various rates in the field. The maximum residue concentration is an upper

- bound defined by Fletcher et al

. (1994) for each food group was derived from literature and tolerance

data.

Dissipation of tolfenpyrad residues on food items following sin gle and multiple applications

were predicted using a first

- order residue degradation half

- life with the T

- REX v1.5 .1 model. T

REX assumes a default foliar dissipation half

- life estimate of 35 days (Willis and McDowell, 1987). This half

- life is used in lieu of foliar dissipation data specific for tolfenpyrad. The maximum predicted residues on avian and mammalian food i tems (dietary EECs) as a result of applications to a variety of c rop areas are provided in Table 3. 6 and 3. 7

.

The residues or EECs on food items may be converted to an ingested single acute oral dose or compared directly with sub

- acute dietary toxicity d ata. Single oral dose estimates represent an exposure scenario where absorption of the pesticide is maximized over a single ingestion event. The EEC is converted to an oral dose by multiplying the EEC by the percentage of body weight

consumed as estimated through allometric relationships. These consumption

- weighted EECs are determined for each food source and body size for birds (20, 100, and 1000 g) and mammals (15, 35, and 1000 g). EEC equivalent doses for birds and mammals are given in Tables 3. 6 and 3. 7

, respectively. Example output from T

- REX for the maximum use scenario is included in Appendix C

.Page 3 3 of 125



### Table 3. 6 Predicted avian exposure concentration estimates for Tolfenpyrad
Dietary Category Dietary

EEC (mg a.i. /kg diet) Dose Based EEC (mg a.i./kg

- bw)

Small (20 g) Medium

(100 g) Large

(1000 g)

Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear

, oriental pear , stone fruits and tree nuts ( 2 apps at 0.27 lb ai/acre , 14

- d interval)
Short grass 114 130 74 33
Tall grass 52 59 34 15
Broadleaf plants 64 73 42 19
Fruits/pods/ seeds 7 8 5 2

Arthropods 44 50.8 29 13

Seeds 1.8 1.0 0.46

Cucurbits (4 applications at 0.21 lb a.i./acre , 14

- d interval)

Short grass 139 159 91 4
Tall grass 64 73 42 19
Broadleaf plants 78 89 51 23
Fruits/pods/ seeds 9 10 6 3
Arthropods 55 62 36 16

Seeds 2.2 1.3 0.6 Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton (2 apps at 0.21 lb a.i./acre , 14

- d interval)
Short grass 89 101 58 26
Tall grass 41 47 26 12
Broadleaf plants 49 57 33 14
Fruits/pods 6 6 4 2
Arthropods 35 39 23 10

Seeds 1.4 0.8 0.36



### Table 3. 7 . Upper

- bound mammalian exposure concentration estimates for Tolfenpyrad
Dietary Category Dietary

EEC (mg a.i./kg diet) Dose Based EEC (mg a.i./kg

- bw)

Small (15g) Medium

(35 g) Large

(1000 g)

Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear

, oriental pear , stone fruits and tree nuts ( 2 apps at 0.27 lb ai/acre , 14

- d interval)
Short grass 114 109 75 17
Tall grass 52 50 34 8
Broadleaf plants 64 61 42 10
Fruits/pods 7 7 5 1.0
Arthropods 44 43 29 6.8

Seeds 1.8 1.0 0.46

Cucurbits (4 applications at 0.21 lb a.i./acre , 14

- d interval)

Short grass 139 133 92 21
Tall grass 64 61 42 10
Broadleaf plants 78 75 52 12Page 34 of 125

Dietary Category Dietary

EEC (mg a.i./kg diet) Dose Based EEC (mg a.i./kg

- bw)

Small (15g) Medium

(35 g) Large

(1000 g)

Fruits/pods 9 8.3 6 1.3
Arthropods 46 52 32 15

Seeds 2.2 1.3 0.6 Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton (2 apps at 0.21 lb a.i./acre , 14

- d interval)
Short grass 89 84 58 14
Tall grass 41 39 27 6.2
Broadleaf plants 49 48 33 7.6
Fruits/pods 6 5 3.6 0.9
Arthropods 35 39 23 10

Seeds 1.4 0.8 0.36



### 3.4.1 Inhalation Exposure

The screening risk assessment also considered acute inhalation exposure from spray material in droplet form at the time of application and vapor phase pesticide volatilizing from treated surfaces. Based on STIR tool (version 1.0) results acute inhalation f rom tolfenpyrad application is not considered an appreciable route of exposure for mammals or birds. See A ppendi x C for model output details.

3.4.2 Dermal Exposure

Though dermal exposure via direct application of ground or aerial spray and by incidental contact with contaminated vegetation, soil and water is expected from labeled methods of application, this screening assessment does not quantify d ermal tolfenpyrad e xposure to terrestrial organisms.

3.4.3 Drinking Water Exposure

Drinking water exposure to a pesticide active ingredient may be the result of consumption of surface water or consumption of the pesticide in dew or other water on the surfaces of treated

vege tation. For pesticide active ingredients with the potential to dissolve in runoff, puddles on the treated field may contain the chemical. The SIP tool (version 1.0) estimates the potential for exposure concerns to birds and mammals via drinking water alon e. Tolfenpyrad’s solubility in water (0.087 mg/L) and toxicity to avian and mammalian species are inputs for the potential

upper

- bound drinking water calculations. For the acute oral endpoints, 58 mg a.i./kg bw (ebra

finch ED 50 

### ) was selected for birds and 239 mg a.i./kg bw (rat LD 50 

### ) for mammals. Inputs for weight of the test organisms included 0.012 kg for birds (mean body weight of birds at zebra finch test initiation) and 0.35 kg for mammals (the default body weight for rats). For birds, a

definitive NOA EC was not established, due to effects at the lowest treatment levels in both submitted reproductive studies (9.7 mg a.i./kg diet for mallard duck and 24.3 mg a.i./kg diet forPage 35 of 125



### bobwhite quail). Therefore, the potential for chronic effects from drinking wate r exposure was not estimated. The c hronic NOA EL value is 0.86 mg a.i./kg bw for mammals

.

Based on the available information, tolfenpyrad exposure through drinking water alone does not present an acute concern for mammals or birds or chronic concern for m ammals. The potential chronic concern from drinking water exposure for birds could not be estimated at t his time

. Based on the assumption employed in SIP that the chemical will be present at the level of solubility, the estimated upper

- bound exposure to bi rds is 0.0150 mg/kg bw. Therefore, any chronic toxicity effects observed at this level would prompt drinking water concerns for tolfenpyrad. However, without definitive chronic NOAECs for birds, the potential concern to

this taxon as a result of chronic dr inking water exposure remains an uncertainty

.

3.4.4 Exposure of Piscivorous Wildlife

Predicted Residues in Aquatic Prey

Two approaches were used to predict residues of tolfenpyrad (and degradates) in aquatic organisms. The first approach relied on the KABAM model (v. 1.0) which uses a food web bioaccumulation model to estimate chemical concentrations in tissues of aquatic organisms. The primary chemical

- specific inputs to the KABAM model are K OW 

### , K OC 

### , surface water EEC, and pore water EEC. For this screening level assessment, the surface water and pore water EEC were selected from the exposure scenario yielding the highest EECs (TX Cotton). Other input parameters are shown below in Table 3.8 and all input parameters and calculations are shown in Ap pendix E.

Table 3.8. Chemical characteristics of Tolfenpyrad (TX Cotton Scenario)

. Characteristic Value Comments/Guidance

Pesticide Name Tolfenpyrad

(TX Cotton)

Log K OW 

### 5.61 Table 3.1

K OW 

### 407380

. K OC 

### (L/kg OC) 29380 Table 3.1 Time to steady state (T S 

### ; days) 113 This value is calculated automatically from the Log K OW 

### value entered above.

Pore water EEC (μg/L) 0.31 From 60

- d average EEC for TX Cotton scenario ( Table 3.5 )

Water Column EEC (μg/L) 0.47 From 60

- d average EEC for TX Cotton scenario ( Table 3.4 )



### Importantly, available data from the BCF study with tolfenpyrad (MRID 48250424) indicates substantially lower bioconcentration than that predicted by the KABAM model using default rates of chemical metabolism by biota (Km = 0). Therefore, mean respiratory uptake and

elimination rate constants determined for whole fis h were selected from the BCF study and used as input for small, medium and large fish (K 1 

### = 651.5 L/kg

- d; K 2


### – 0.214 d - 1 

### ). Since the elimination rate constant from the BCF study represents total elimination (sum of respiratoryPage 36 of 125



### elimination, metabolism , die tary elimination), rate constants for all but respiratory elimination

were set to zero for fish.

The resulting predicted concentrations of tolfenpyrad in the aquatic food web are shown in Table

3.9.

Table 3.9. Estimated concentrations of Tolfenpyrad (TX Cotton) in ecosystem components.

Ecosystem Component Total

concentration (μg/kg

- ww) Lipid

normalized

concentration (μg/kg

- lipid) Contribution

due to diet (μg/kg

- ww) Contribution

due to respiration (μg/kg

- ww) Water (total)* 0.47 N/A N/A N/A

Water (freely dissolved)* 0.47 N/A N/A N/A Sediment (pore water)* 0.31 N/A N/A N/A Sediment (in solid)** 364 N/A N/A N/A Phytoplankton 8,036 401795 N/A 8,035.90 Zooplankton 7,146 238190 735.24 6,410.46

Benthic Invertebrates 8,559 285299 1,958.67 6,600.29

Filter Feeders 5,610 280498 1,263.39 4,346.58

Small Fish 3,254 81354 1,855.85 1,398.30

Medium Fish 2,392 59793 990.41 1,401.32 Large Fish 1,712 42796 284.30 1,427.53 * Units: μg/L; **Units: μg/kg

- dw



### The predicted BCF and BAF values for tolfenpyrad are shown in Table 3.10 . Notably, BCF values for whole fish are similar to those from the submitted BCF study. The predicted BCF and BAF values for the lower food web components are greater than those for fish because no

information was available for es timating metab olism rates for these organisms and no adjustments were made to model

- calculated rates for uptake, elimination or metabolism.

Table 3.10 . Total BCF and BAF values of Tolfenpyrad (TX Cotton) in aquatic trophic levels.

Trophic Level Total BC F (μg/kg

- ww)/(μg/L) Total BAF (μg/kg

- ww)/(μg/L) Phytoplankton 19555 17098 Zooplankton 13933 15204

Benthic Invertebrates 14957 18211

Filter Feeders 9832 11936

Small Fish 2993 6924

Medium Fish 2993 5089 Large Fish 3044 3642



### The second approach used to predict tolfenpyrad in aquatic organisms involved the use of the measured bioconcentration factor (BCF). Specifically, a steady

- state, whole

- fish BCF of 3,008 L/kg wet wt was used in conjunction with the maximum 60

- d average EE C in surface water (0.47) to estimate tolfenpyrad TROC in fish tissue . This whole body fish BCF represents concentrations of parent tolfenpyrad and any degradate s that formed during the exposure portionPage 37 of 125



### of the BCF study. Because residues of specific degradates were not quantified in this BCF study,

it is not known what fraction of the residues in water or fish tissue represented parent or degradation products.

Using the results of the empirical fish BCF studies, the residue concentrations in fish can be predicted using the following equation:

Residue in fish (μg/kg wet wt) = BCF (L/kg whole fish) * 60

- d EEC (μg/L)

For the parent compound: If the BCF is multiplied by the maximum 60

- day EEC for tolfenp yrad, then the predicted residue concentration in fish is 3008 L/kg wet wt x 0. 47 μg/L =

1 ,413 μg/kg wet wt or 1. 4 mg/kg wet wt

.

These residue values are used for risk estimation in Section 5.1.

3. 5 Terrestrial and Semi

- Aquatic Plant Exposure Estimates

Terrestrial and semi

- aquatic plants may be exposed to pesticides from runoff, spray drift, or

volatilization. Semi

- aquatic plants are those that inhabit low

- lying wet areas that may be dry at certain times of the year. The runoff scenario in TerrPlant v1.2.2 is: (1) based on a pesticide's water solubility and the amount of pesticide present on the soil surface and its top one centimeter, (2) characterized as "sheet runoff" (one treated acre to an adjacent acre) for dry areas, (3) characterized as "chan nel runoff" (10 acres to a distant low

- lying acre) for semi

- aquatic or wetland areas, and (4) based on runoff values of 1, 2, and 5% for water solubility values of <10,

10

- 100, and >100 ppm, respectively. Spray drift is assumed as (1) 1% for ground applica tion, (2) 5% for aerial, airblast, forced air, and spray chemigation applications, and (3) 0% for granular applications. Currently, EFED derives plant exposure concentrations from a single maximum application rate only. Exposure through volatilization is n ot accounted for in this baseline assessment. However, based on the low vapor pressure of tolfenpyrad, volati li zation is not expected to be a significant route of exposure. EECs are presented in Table 3. 11 . The TerrPlant model outputs are provided in Appen dix D.

Table 3. 11 . Tolfenpyrad exposure to terrestrial and semi

- aquatic plants based on maximum proposed use rate

Description Ground spray EECs (lbs a.i./A) Aerial spray EECs (lbs a.i./A)

Runoff to dry areas 0.0027 0.0021

Runoff to semi

- aquatic areas 0.027 0.021
Spray drift 0.0027 0.0021
Total for dry areas 0.0027 0.0042

Total for semi

- aquatic areas 0.0297 0.0231Page 38 of 125



## 4 .0 Ecological Effects Analysis

Only studies submitted by the registrant were evaluated to determine the effects of tolfenpyrad

on non

- target organisms. A search of the public ECOTOX database ( http://cfpub.epa.gov/ecotox ) on January 12, 2011 did not yield any additional aquatic or terrestrial open literature studies for tolfenpyrad. No eco logical incidents hav e been reported to the Agency for tolfenpyrad in the

United States.

4.1 Aquatic Effects Summary

The acute and chronic toxicity of tolfenpyrad was determined for a variety of fish, invertebrate and algal species. Acute toxicity studies were also conducted on selected species with the end

use products, as well as 4 acute freshwater fish studies with the degradates PT(A)

- 4OH, PCA,

PAM and PT

- CA a nd the r ainbow trout

, Oncorhynchus mykiss and 1 acute stu dy with PC

- TA

and a freshwater c arp
, Cyprinus carpio

.

In studies where only nominal concentrations are reported, tolfenpyrad toxicity is may be underestimated or overestimated, particularly if tolfe npyrad is unstable in the test conditions and degrades to metabolites that differ from those that comprise the modeled exposure concentrations. Stability problems were observed in the submitted acute studies with Tolfenpyrad 15SC conducted with one fish s pecies. The studies that reported nominal concentrations only were not used in risk estimation.

4.1.1 Toxic Effects to Fish

Acute Toxicity

Freshwater Fish For freshwater fish species, tolfenpyrad is very highly toxic on an acute basis ( Table 4.1 )

. Freshwater fish studies are also used as a surrogate for aquatic

- phase amphibians. In 96

- hour studies with bluegill ( Lepomis macrochirus ), the LC 50 

### is 0.94 μg ai/L for tolfenpyrad technical

and LC 50 

### is 1.02 μg ai/L for the end

- use product Tolfenpyrad 15% SC (MRIDs 47447721 and 48250415). The bluegill study with the end

- use product was classified as supplemental, due to poor recovery of the test compound under the static conditions of the test.

Rainbow trout ( Oncorhynchus mykiss ) appeared to be slight ly more sensitive to tolfenpyrad than bluegill based on the available acute studies. For the technical product, the LC 50 

### for rainbow trout is 0.163 μg ai/L, and in the submitted study conducted with Tolfenpyrad 15% SC, the LC 50 

### for this species is 0.114 μg ai/L (MRIDs 48250413 and 48250416). The rainbow trout study with

the end

- use product was classified as supplemental, due to poor recovery of the test compound

under the static conditions of the test.Page 39 of 125



### Three acute studies with tolfenpyrad technical and carp ( Cyprinus carpio ) were also submitted.

All three studies were classified as supplemental. For the carp study using tolfenpyrad technical,

the LC 50 

### is 3.2 μg a.i./ L (MRID 47447719). This study was determined to be supplemental due to instability of the te st material under the test conditions. For the carp study using tolfenpyrad EC, the LC 50 

### is 45 μg a.i. /L (MRID 47447720). This study was also classified as supplemental because only nominal test concentrations were reported. An additional study was submitt ed with

carp exposed tolf

enpyrad SC. In this test, the LC 50 

### is 20 μg a.i./ L , but the study is classified as supplemental because the chemical concentrations were not analytically verified and the results

are based on nominal concentrations ( MRID 48250417).

Estuarine/Marine Fish

The single acute study was submitted for estuarine/marine fish indicates that tolfenpyrad is very highly toxic to this taxon on an acute basis . This study was conducted with tolfenpyrad technical and the test species sheepshead minnow ( Cyprinodon variegatus ) and the 96

- hour LC 50 

### is 3.38 μg ai/L (MRID 48250414).

Chronic Toxicity

Freshwater Fish

Both a 33

- day early life stage study and a 30

- week full life cycle study were submitted for the freshwater fish species fathead minnow ( Pimephales promelas ). In the early life stage study, effects on growth were observed at the all treatment levels, 0.014 μg TRR/L to 484 μg TRR/L, compared to the negative control. However, the negative control re sults were confounded by the fact that one exceptionally large fish was present in this group, and skewed the variance for weight measurements. In addition, seven fish were lost in transfer during the test, and this could

result in more food for the remain ing test organisms in the negative control. Therefore, the growth results for this test are not reliable, and the NOAEC is for survival only. This may potentially underestimate toxicity, due to the lack of a reliable growth endpoint for this study. (MRID 4 8250422). This study is classified as supplemental, because the chemical concentrations were only reported in terms of total radioactive residues, and the observed radioactivity was not characterized as parent or degradates . In addition, substantial variab ility in the measured chemical concentrations occurred among samples within a given treatment level. In the full life cycle study, the NOAEC is 0.189 μg ai/L , based on reductions in juvenile survival and clinical signs of toxicity at the 0.395 μg ai/L trea tment level and higher (MRID 48250423). The study was also classified as supplemental, because the treatment concentrations were only reported in

terms of total radioactive residues and the observed radioactivity was not characterized as parent or degradat es

.

Estuarine/Marine Fish An early life stage study with the estuarine/marine fish species sheepshead minnow ( Cyprinodon variegatus ) was also submitted for tolfenpyrad technical. In this study, the NOAEC is 0.186 μg ai/L , based on reductions in growth and clinical signs of toxicity at the 0.573 μg ai/L treatment level and higher (MRID 4825042 1 ) . This study is classified as supplemental, due to analytical variability in test concentration measurements and because the treatment concentrations were only re ported in terms of total radioactive residues. The observed radioactivity was not characterized as parent or degradates

.Page 40 of 125 

### Degradation Products

Tofenpyrad PCA, PC

- TA, PT(A)

- 4OH and PAM metabolites were of less concern with fish with

observed acute LC 50 

### values ranging from 640 ppb to over 10,000 ppb , which are over 4000 times less toxic than the parent for Rainbow trou t (LC 50 

### 0.163 ppb)

.

Table 4. 1 summarizes the available tolfenpyrad toxicity studies submitted to the Agency for fish species.

Table 4.1 Acute and chronic toxicity of tolfenpyrad and its major degradation products to

fish.

Percent

Active Ingredient Species Toxicity Value (Endpoints) Acute Toxicity

Classification Study

Classification MRID

citation

99.5 Bluegill sunfish

,

Lepomis m acrochirus 96 hr LC 50 = 0.94 μg a.i./L

NOAEC = 0.24 μg a.i./L Very highly

toxic Acceptable 47447721

15.4 SC Bluegill sunfish 96 hr LC 50 = 1.02 μg a.i./L

NOAEC = 0.37 μg a.i./L Very highly

toxic Supplemental 48250415

99.5 Rainbow trout,

O ncorhynchus mykiss 96 hr LC 50 = 0.163 μg a.i./L*

NOAEC = 0.059 μg a.i./L Very highly

toxic Acceptable 48250413

15.4 Rainbow trout 96 hr LC 50 = 0.740 μg form /L ( = 0.114 ppb of active/L) NOAEC = 0.387 μg form ./L Very highly

toxic Supplemental 48250416

99.3 Common carp
,

Cyprinus carpio 96 hr LC 50 = 3

. 2 u g a.i./L

NOAEC < 2 .4 u g a.i./L Very highly

toxic Supplemental 474477 19

15.5 E C Common carp 96 hr LC 50 = 45 ug form /L

NOAEC = 18 ug form

/L H ighly toxic Supplemental 47447720

15.9 SC Common carp 96 hr LC 50 = 20 ug form /L NOAEC = 10 ug form /L H ighly toxic Supplemental 4825041 7

99.4 Fathead minnow,

Pimephales promelas 33 Day Early Life NOAEC =

0.188 * μg TRR/L LOAEC = 0.484 μg TRR/L Not applicable Supplemental 482504 22

99.4 Fathead minnow 210 Day Lifecycle NOAEC = 0.189 μg T RR/L LOAEC = 0.395 μg TRR/L Not applicable Supplemental 482504 23

99.5 S heepshead minnow

,

Cyprinodon variegatus 96 hr LC 50 = 3.38 μ g a.i./L *

NOAEC = 1.22 μ g a.i./L Very highly

toxic Acceptable 48250414

99.4 S heepshead minnow 34 day Early Life NOAEC = 0.186 μg TRR/L* LOAEC = 0.573 μg TRR/L Not applicable Supplemental 482504 21

Metabolite Acute Toxicity Test Results

99.6 PT(A)

- 4OH Rainbow trout 3100 ug ai/L Moderately

toxic Acceptable 48953801

99.7 PCA Rainbow trout > 9700 ug ai/L > Moderately

toxic Acceptable 48953802

99.7 PAM Rainbow trout >10,000 ug ai/L > Slightly

t oxic Acceptable 48953803

100 PT

- CA Rainbow trout 640 ug ai/L Moderately Acceptable 48953804Page 41 of 125



### 4.1.2 Toxic Effects to Aquatic Invertebrates

Acute Toxicity

Freshwater Invertebrates Tolfenpyrad technical is very highly toxic to aquatic invertebrates on an acute basis ( Table 4.2 )

. Based on observations of daphnid immobilization at measured concentrations, the 48

- hour EC 50



### was 1 μg a.i./ L (MRID 47490701). An acute aquatic invertebrate toxicity test for the end

- use product T olfenpyrad 15EC was also submitted. This study also indicated very high toxicity to daphnids, with a 48

- hour EC 50 

### of 1

. 2 μg a.i./ L (MRID 47447718). However, this study reported only nominal concentrations and is classified as supplemental.

Estuarine/marine Invertebrates

Two studies were submitted that examined the acute toxicity of tolfenpyrad to estuarine/marine invertebrate species. In a test conducted on the saltwater mysid ( Americamysis bahia) , the 96

- hour LC 50 

### was determined to be greater than 12 μg ai/L (MRID 48250412). This study was classified as supplemental, because t he test material was not tested at high enough concentrations

to determine a definitive LC 50 

### . An acute 96

- hour study was also conducted with the eastern oyster ( Crassostrea virginica ), which resulted in an EC 50 

### greater than 7.8 μg a.i./L (MRID 48250411). This study is classified as supplemental because the test concentrations did not

bracket the EC 50



### .

Chronic Toxicity

Freshwater Invertebrates

A full

- life cycle study with tolfenpyrad technical was submitted for the freshwater invertebrate Daphnia magna (MRID 48250418). Based on the results of this study, chronic effects such as delayed offspring production and reduction in the number of offspring were observed at

concentrations of 0.482 μg a.i./L or greater. The NOAEC for this study was defined as 0.244 μg a.i./L

.

Estuarine/marine Invertebrates

A full

- life cycle study with tolfenpyrad technical was submitted for the saltwater mysid Americamysis bahia (MRID 48250420). Based on the results of this study, chronic effects such as reductions in offspring pr oduction and juvenile survival were observed at concentrations of 5.4 μg a.i./L or greater. The NOAEC for this study was defined as 2.3 μg a.i./L. This study was classified as supplemental due to analytical variation and because the treatment concentration s were only reported in terms of total radioactive residues (the observed radioactivity was not characterized as parent or degradates ).

Benthic Invertebrates

A 28

- day spiked sediment study with the freshwater benthic midge Chironomus riparius was submitte d that examined the effects of tolfenpyrad technical on emergence and development rate. toxic

PC

- TA Common carp 940 ug ai/L Moderately

toxic 48660302Page 42 of 125



### In this study, no adverse effects were observed on midge emergence or development rate at the highest treatment level, > 0. 391 μ g TRR/kg sediment or > 0.0 2 9 μ g TRR/L pore water . This study is considered supplemental information, as the treatment concentrations were reported in terms

of total radioactive residues (the observed radioactivity was not characterized as parent or degradate) , the test was not conducted with an OC SPP guidelines species (MRID 48250425) and no reproductive endpoints were evaluated.

Transformation Products

No acute or chronic aquatic toxicity information was submitted for any degradate of tolfenpyrad with aquatic invertebrates.

Table 4.2 summarizes the available tolfenpyrad toxicity studies submitted to the Agency for aquatic invertebrates.

Table 4.2 . Tolfenpyrad Toxicity to Aquatic Invertebrates

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Acute

Toxicity

Classification Study

Classification MRID

citation

48

- hour

acute 99.3 Daphnia

magna (daphnid) EC 50 = 1.00 μg

a.i./L*

NOAEC = 0.500 μg a.i./L Very highly

toxic Acceptable 47490701

48

- hour

acute 15.5

Tolfenpyrad

15 EC Daphnia

magna (daphnid) EC 50 = 1.2 μg

a.i./L

NOAEC = 0.30 μg a.i./L Very highly

toxic Supplemental 47447718

21

- day

chronic

life

- cycle 99.5 Daphnia

magna (daphnid) NOAEC = 0.244

μg a.i./L*

LOAEC = 0.482 μg a.i./L Not applicable Acceptable 48250418

28

- day

chronic 99.4 Chironomus riparius (midge) Time

- Weighted

Average

Sediment

Concentrations

NOAEC: 0. 391

μ g TRR/kg

LOAEC: > 0. 391

μ g TRR/kg

Time

- Weighted Average Pore

Water

Concentrations

NOAEC: 0.029

μ g TRR/L

LOAEC: > 0.029

μ g TRR/L Not applicable Supplemental 48250425

96

- hour

acute 99.5 Crassostrea virginica (Eastern EC 50 > 7.80 μg

a.i./L

NOAEC = 1.82 Could not be

determined Supplemental 48250411Page 43 of 125



### 4.1.3 Toxic Effects to Aquatic Vascular Plants and Algae

The submitted tolfenpyrad technical study for Lemna gibba indicates that tolfenpyrad is not toxic aquatic vascular plants up to the highest concentration tested, 30 μg a.i./L (MRID 48250436). This study was classified as supplemental because the EC 50 

### value could not be defined.

Tolfenpyrad technical showed a range of phytotoxic effects to algae. The EC 50 

### values in the submitted studies ranged from 1.00 μg a.i./L for Pseudokirchnierella subcap itata (freshwater algae) to greater than 87 μg a.i./L for another freshwater algal species, Anabaena flos

- aquae

. Many of the submitted studies with tolfenpyrad technical were considered supplemental because

the treatment concentrations did not allow calcul ation of a definitive EC 50 

### . The study conducted with tolfenpyrad technical and Skeletonema costatum is considered supplemental because the initial cell density in this study is approximately 1/8 the recommended density in OCSPP 850.

5400 (MRID 48250440).

Two acute algal studies were also submitted for the tolfenpyrad end

- use products. For tolfenpyrad 15% EC, the EC 50 

### is 18 0 μg ai/L (MRID 47447726). However, this study reported only nominal concentrations and is classified as supplemental. Another submitte d study with tolfenpyrad 15% SC resulted in an EC 50 

### of 320 μg ai/L (MRID 48250441 ) . This study was also classified as supplemental because no measured concentrations were reported.

Table 4. 3 summarizes the available tolfenpyrad toxicity studies for aquat ic vascular plants and algae. The Office of Pesticide Programs has not established toxicity classifications for aquatic plants.

Table 4.3 . Tolfenpyrad Toxicity to Aquatic Vascular Plants and Algae oyster) μg a.i./L

96

- hour

acute 99.5 Americamysis

bahia (saltwater mysid) L C 50 > 12 μg

a.i./L NOAEC = 12 μg

a.i./L Could not be

determined Supplemental 48250412

35

- day

chronic life cycle 99.5 Americamysis

bahia (saltwater mysid) NOAEC = 2.3 μg

TRR/L* LOAEC = 5.4 μg

TRR/L Not applicable Supplemental 48250420

*Toxicity value used in risk estimation.

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Study

Classification MRID

citation

7

- day 99.5 Lemna gibba (duckweed) EC 50 >30 μg a.i./L

NOAEC = 30 μg a.i./L* Supplemental 48250436

72

- hour

acute 99.3 Pseudokirchnierella subcapitata (freshwater algae) EC 50 = 1.00 μg a.i./L*

NOAEC = 0.500 μg a.i./L* Acceptable 47447725Page 44 of 125



### 4.2 Terrestrial Effects Summary

Fourteen studies were submitted that evaluated the effects of tolfenpyrad to terrestrial non

- target organisms. The plant studies were conducted using a technical end

- use product (TEP), Tolfenpyrad 15% SC. Tolfenpyrad acute toxicity to birds and mammals ranges from practically

non

- toxic to moderately toxic. Chronic effects were also observed at environmentally

- relevant

concentrations for birds and mammals.

4.2.1 Toxic Effects on Birds

Toxicity studies with tolfenpyrad were performed with bobwhite quail ( Colinus virginianus ), mallard duck (

Anas platyrhynchos ), and zebra finch ( Poe phila guttata ) . An overview of avian toxicity data is given in Table 4. 4

.

Acute and short

- term dietary toxicity

For avian species, tolfenpyrad is moderately toxic on an acute oral basis, and slightly toxic based

on a 5

- day dietary study. Bird studies are also used as a surrogate for terrestrial

- phase amphibians and reptiles. The LD 50 

### for bobwhite quail ( Colinus virginianus ) was 87 mg ai/kg bw,

b ased on an acute oral dosing followed by a 14

- day observational period (MRID 47447722). In the acute oral study with the zebra finch ( Poephila guttata ), an LD 50 

### could not be calculated due to substantial levels of regurgitation at all treatment levels in t he study. T he calculated ED 50 

### for this study was 58.0 mg a.i./kg bw, based on treatment

- related regurgitation effects (MRID

48250426 ).

For the 5

- day dietary studies conducted with avian species, the LC 50 

### was 1348 mg ai/kg diet for bobwhite quail and the LC 50 

### was 3543 mg ai/kg diet for mallard duck (MRIDs 47447723 and 48250427). 96

- hour

acute 99.5 Pseudokirchnierella subcapitata (freshwater algae) EC 50 > 10 μg a.i./L

NOAEC = 2.7 μg a.i./L Supplemental 48250437

72

- hour

acute 15.5

Tolfenpyrad

15 SC Pseudokirchnierella

subcapitata (freshwater algae) EC 50 = 180 μg ai/L

NOAEC = 102 μg a.i./L Supplemental 47447726

72

- hour

acute 15.9

Tolfenpyrad

15E C Pseudokirchnierella

subcapitata (freshwater algae) EC 50 = 320 μg a.i./L

NOAEC = 5 μg a.i./L Supplemental 48250441

96

- hour

acute 99.5 Anabaena flos

- aquae (freshwater algae) EC 50 >87 μg a.i./L

NOAEC = 87 μg a.i./L Supplemental 48250438

96

- hour

acute 99.5 Navicula pelliculosa (freshwater diatom) EC 50 >24 μg a.i./L

NOAEC = 24 μg a.i./L Supplemental 48250439

96

- hour

acute 99.5 Skeletonema costatum (marine diatom) EC 50 = 5.2 μg a.i./L

NOAEC = 1.2 μg a.i./L Supplemental 48250440

*Toxicity value used in risk estimation.Page 45 of 125 

### Chronic toxicity

Two studies were submitted that examined the chronic toxicity of tolfenpyrad dietary exposure to avian species. Tolfenpyrad showed chronic toxic effects to birds at levels as low 9.7 mg a.i./kg diet. Both the study submitted for bobwhite quail ( Colinus virginianus ) or mallard duck ( Anas platyrhynchos ) were classified as supplemental, as effects were observed at the lowest trea tment
level and a NOAEC could not be defined.

In the submitted chronic study with bobwhite quail, eggs set/eggs laid was reduced by 4 percent (statistically significant) at the lowest treatment level, 24.3 mg a.i./kg diet. The biological significance of t his reduction is not clear however, as the number of eggs set/eggs laid was not

observed at the other two higher treatment levels. The number of hatchlings/eggs laid was reduced by 9

- 15% at the two lowest treatment levels and not the highest treatment leve l. In this study, hatchling survival per pen is also reduced at the second highest treatment level only, 51.1 mg a.i./kg diet. No other parameters showed statistical difference from the controls (MRIDs 48250430 and 48250431).

In the study with mallard duc ks, a statistically

- significant reduction in the number of eggs set to eggs laid was observed at all treatment levels

, 9.7 mg a.i./kg diet and greater. The reduction did not increase with dose and remained fairly constant, between a 10 to 11 percent reduct ion compared to the controls (MRIDs 48250428 and 48250429).

Table 4. 4 summarizes the available tolfenpyrad toxicity studies conducted with avian species.

Table 4.4 . Tolfenpyrad Toxicity to Birds

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Acute

Toxicity

Classification Study

Classification MRID

citation

Acute single oral dose, 14

- day

observation period 99.5 Zebra finch ( Poephila

guttata ) E D 50 = 58.0 mg

a.i./kg bw *

NOAEL < 13.0 mg a.i./kg bw Could not be

determined Supplemental 48250426

Acute single oral dose, 14

- day

observation period 99.3 Northern bobwhite quail ( Colinus virginianus ) LD 50 = 87 mg

a.i./kg bw

NOAEL <25 mg a.i./kg bw Moderately

toxic Acceptable 47447722

Subacute 5

- day dietary

exposure, 4

- day

observation period 99.3 Northern bobwhite quail ( Colinus virginianus ) LC 50 = 1348 mg

a.i./kg diet *

NOAEC <156 mg a.i./kg diet Slightly toxic Acceptable 47447723

Subacute 5

- day dietary

exposure, 4

- day

observation period 99.5 Mallard duck ( Anas platyrhynchos ) LC 50 = 3543 mg

a.i./kg diet

NOAEC <98 mg a.i./kg diet Slightly toxic Acceptable 48250427Page 46 of 125



### 4.2.2 Toxic Effects on Mammals

Acute oral, dermal and inhalation studies with tolfenpyrad were conducted on rats. A one

generation reproduction study with tolfenpyrad was also submitted. Results of the mammalian toxicity studies are summarized in Table 4. 5 . Formal reviews of the acute mammalian data were conducted by the Registration Division (DP 354428). The Health Effects Division reviewed the chronic mammalian dietary study described be low (D383820)

. All studies were classified as acceptable.

Acute toxicity

Tolfenpyrad is practically nontoxic to moderately toxic to mammals on an acute oral basis ( m ale

LD 50 

### ≥ 386 mg a.i./kg bw; f emale LD 50 

### ≥ 150 mg a.i./kg bw ; c ombined LD 50 

### ≥ 239 mg a.i ./kg

bw ). Mortality was observed at all treatment levels, excluding the lowest treatment (50 mg a.i./kg bw). Of the treated animals, 1 of 5 rats died at 75 mg a.i./kg bw , 1 of 10 rats died at 100 mg a.i./kg bw , 2 of 10 rats died at 150 mg a.i./kg bw , 6 of 10 rats died at 250 mg a.i./kg bw , 4 of 5

rats died at 500 mg a.i./kg bw and 4 of 5 rats died at 750 mg a.i./kg bw . Clinical signs of toxicity were observed at treatment levels as low as 50 mg a.i./kg bw, and included thin appearance, red

stained face, alopecia on the nape of neck, soft stool, and yellow stained urogenital area (MRID 47457501).

On an inhalation basis, the tolfenpyrad mammalian LC 50 

### males > 2.21 mg a.i./L, LC 50 

### females > 1.50 mg a.i./L and LC 50 

### combined > 1.82 mg a.i./L. One of 10 test animals died at this treatment level. At the two highest treatment levels (3.99 mg a.i./L and 5.32 mg a.i./L), 2 out of 10 and 7 out 10 test animals died, respectively. L ungs were abnormally red, had dark patches, hemorrhagic, and dark foci in animals that died or were sacrificed (MRID 47447734 ).

Chronic toxicity

Chronic reproductive effects were observed at low levels of tolfenpyrad exposure. In the

submitted one

- generation reproduction conducted on rats, the parental NOAEL was 15 ppm or 0.86/0.92 mg a.i ./kg/day for males and females, respectively. Decreased body weight gain and 20

- week

chronic dietary

exposure 99.5 Mallard duck ( Anas platyrhynchos ) NOAEC <9.7

mg ai/kg diet

LOAEC = 9.7 mg ai/kg diet Not applicable Supplemental 48250428

and

48250429

22

- week

chronic dietary

exposure 99.5 Northern bobwhite quail ( Colinus virginianus ) NOAEC <24.3

mg ai/kg diet

LOAEC = 24.3 mg ai/kg diet Not applicable Supplemental 48250430

and

48250431

*Toxicity value used in risk estimation.Page 47 of 125



### food consumption were observed at tolfenpyrad concentrations of 50 ppm ( 2.7/2.9 mg/kg/day ) and greater. Adverse effects on body weight of offspring were observed at the same level s, resulting in an offspring NOAEL of 50 ppm. The gestation duration for female rats was

increased at treatment levels of 100 ppm ( 4.8/4.4 mg a.i./kg/day) and greater. Therefore, the NOAEL in this study for reproductive endpoints was 50 ppm ( 2.7/2.9 mg/kg/ day ) (MRID 47447816). Table 4. 5 summarizes the available tolfenpyrad toxicity studies conducted with mammalian species.

Tab le 4.5 . Tolfenpyrad Toxicity to Mammals

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Acute

Toxicity

Classification Study

Classification MRID

Citation

Single oral dose, 14

- day

observation period 99.3 Laboratory

Rat ( Rattus norvegicus ) Male LD 50 ≥ 386 mg

a.i./kg bw

Female LD 50 ≥ 150 mg a.i./kg bw

Combined LD 50 ≥ 239 mg a.i./kg bw * Moderately

nontoxic to practically

nontoxic Acceptable 47457501

4

- hour

inhalation dose (nose only) Purity not

reported,

technical grade

active ingredient Laboratory

Rat ( Rattus norvegicus ) Male LC 50 ≥ 2.21 mg

a.i./L

Female LC 50 ≥ 1.50 mg

a.i./L

Combined LC 50 ≥ 1.82 mg a.i./L Not applicable Acceptable 47457734

One

generation rat reproduction study, dietary

exposure began 4 weeks prior to mating and

lasted throughout mating, gestation and

lactation periods 99.8 Laboratory

Rat ( Rattus norvegicus ) Parental NOAEL = 15

ppm or 0.86/0.92 mg a.i./kg bw/day *

Parental LOAEL = 50 ppm or 2.7/2.9 mg a.i./kg bw/day

Reproductive NOAEL = 50 ppm or 2.7/2.9 mg a.i./kg bw/day Reproductive LOAEL = 100 ppm or 4.8/4.4 mg a.i./kg bw/day

Offspring NOAEL = 15 ppm or 0.86/0.92 mg

a. i./kg bw/day * Offspring LOAEL = 2.7/2.9 mg a.i./kg bw/day Not applicable Acceptable 47447816

*Toxicity value used in risk estimation.Page 48 of 125



### 4.2.3 Toxic Effects on Terrestrial Invertebrates

The honey bee is used as a surrogate for all terrestrial non

- target invertebrates. For the technical grade active ingredient, tolfenpyrad is classified as highly toxic based on the acute contact honey bee study (LD 50 

### = 0.47 μg a.i./bee). Similarly, the acu te oral study with honey bees resulted in an

LD 50 

### of 0.63 μg a.i./bee. Behav ioral abnormalities included un coordinated movements and apathy in both the acute contact and oral study

.

In the acute contact study at 24 hours, 3, 13, 40, 30, and 7% of bees in the 0.16, 0.3, 0.6, 1.3, and 2.5 μg ai/bee test levels (all test concentrations), respectively, displayed uncoordinated movements and apathy. Most of the bees were dead at the 0.6 μg ai/bee treatment level and above. After 96 hours, 10 and 3% of the remai ning bees in the 0.6 and 1.3 μg ai/bee test levels, respectively, displayed abnormalities.

In the acute oral study at 4 hours, 3, 13, and 77% of bees in the 0.39, 0.69, and 1.16 μg ai/bee test levels (three highest test concentrations), respectively, disp layed uncoordinated movements and apathy. By 48 hours there were no abnormalities present, but there was almost complete mortality in the 1.16 μg ai/bee test level.

In this study, 40 percent of the bees died following exposure to tolfenpyrad residues age d 8 hours after application at 0.266 lbs ai/A (approximately twice the maximum application rate in currently proposed labels). After 24 hours, 13 percent of exposed bees died. Twenty percent of bees died when exposed to tolfenpyrad residues 48 hours post

- a pplication. Although the treatment bee response to residues aged 24

- hours or greater was not statistically significant from the control (5% mortality), the mortality at these treatment levels was substantial and did not

follow a dose

- response pattern. The RT 25 

### is likely between 8 hours and 48 hours, and NOAEL could not be determined in this study.

The results from both the acute and contact toxicity tests conducted with terrestrial invertebrates

are summarized in Table 4. 6

.

Table 4.6 . Tolfenpyrad Toxicit y to Nontarget Terrestrial Invertebrates

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Acute

Toxicity

Classification Study

Classification MRID

Citation

96

- hour

acute
contact and oral toxicity

test 99.3 Honey bee (Apis mellifera ) Contact toxicity

LD 50 = 0.47 μg

a.i./bee ; NOAEL = 0.3 μg a.i./bee Oral toxicity

LC 50 = 0.63 μg

a.i./bee ; NOAEL = 0.27 μg a.i./bee Highly toxic Contact toxicity test: Acceptable

Oral toxicity

test: Supplemental 48250432

24

- hour

exposure to
foliar

residues 16.5% a.i.

(Tolfenpyrad 15% SC) Honey bee

(Apis mellifera ) 8 hours< RT 25 <48

hours

NOAEL = could

not be determined Not applicable Supplemental 48250433Page 49 of 125



### 4.2.4 Toxic Effects on Terrestrial Plants

There were no effects in the submitted studies that resulted in an inhibition of 25% or greater for any parameter measured. The seedling emergence and vegetative vigor studies were conducted with a single treatment level of 0. 265 lbs a.i./A, which approxim ate s the current maximum single application rate of 0.27 lb a.i./A. Some uncertainty exists regarding the effects of tolfenpyrad on seedling emergence, as a NOAEC could not be established for one dicot species, Lactuca sativa (lettuce). For lettuce, tolfe npyrad exposure at 0.265 lbs a.i./A caused up to 14 percent inhibition of seedling emergence and survival (MRID 48250434).

Both studies were conducted with Tolfenpyrad 15SC. No studies have been submitted that examine the toxicity of Tolfenpyrad 15EC to t errestrial plants.

The results of the two available tolfenpyrad studies with terrestrial plants are summarized in

Table 4. 7

. The Office of Pesticide Programs has not established toxicity classifications for terrestrial plants.

Table 4.7 . Tolfenpyrad Toxi city to Terrestrial Plants

Study Type Percent

Active Ingredient Species Toxicity Value (Endpoints) Study

Classification MRID

Citation

Seedling

emergence 16.3

(Tolfenpyrad 15% SC) Monocot species :

(corn, Zea mays ; onion, Allium cepa ;

ryegrass, Lolium

perenne ; and wheat,

Triticum aestivum )

Dicot species : (radish, Raphanus sativus ; sugarbeet, Beta vulgaris ; lettuce,

Lactuca sativa ; flax,

Linum usitatissimum ; soybean, Glycine max ; and tomato, Lycopersicon

esculentum ) Monocot species *

EC 25 /IC 25 :

> 0.265/0.270 lbs ai/A

EC 05 /IC 05 : >0.265/0.270 lbs ai/A

NOAEC: 0.265/0.270

lbs ai/A

Dicot species

EC 25 /IC 25 : >0.265 lbs

ai/A

EC 05 /IC 05 : <0.265 lbs

ai/A

NO A EC: <0.265 lbs

ai/A (based on 14%

reduction in lettuce seedling emergence and survival) Supplemental 48250434

Vegetative vigor 16.3

(Tolfenpyrad 15% SC) Monocot species :

(corn, Zea mays ; onion, Allium cepa ;

ryegrass, Lolium

perenne ; and wheat,

Triticum aestivum )

Dicot species : (radish, Raphanus sativus ; Monocot species

EC 25 /IC 25 : >0.265 lbs

ai/A

EC 05 /IC 05 : >0.265 lbs

ai/A

NOAEC: 0.265 lbs

ai/A Acceptable 48250435Page 50 of 125



### 4.5 Review of ECOTOX Data

A search of the public ECOTOX database ( http://cfpub.epa.gov/ecotox ) was conducted on January 12 , 2011 . No studies were found that evaluated the effects of tolfenpyrad on non

- target organisms.

4.6 Review of Incident Data

There are no ecological incidents reported for tolfenpyrad, as expected for a chemical with no previously registered outdoor uses.

A review of the Ecological Incident Information System ( EIIS, v. 2.1) and Aggregate Incident databases for ecological inci dents involving tolfenpyrad was completed on December 27 , 2011.

A search for tolfenpyrad was also conducted in the American Bird Conservancy’s Avian Incident Monitoring System (AIMS), which contains publicly available data on reported avian incidents involving pesticides ( http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfm ). sugarbeet, Beta vulgaris ; lettuce,

Lactuca sativa ; flax,

Linum usitatissimum ; soybean, Glycine max ; and tomato, Lycopersicon

esculentum ) Dicot species

EC 25 /IC 25 : >0.265 lbs

ai/A

EC 05 /IC 05 : >0.265 lbs

ai/A

NOAEC: 0.265 lbs

ai/A

* Measured concentrations for all species except onion, sugarbeet, and tomato were <LOQ (<0.0352 lbs ai/A, control), and 0.265 lbs ai/A, and were <LOQ (<0.0362 lbs ai/A , control), and 0.270 lbs ai/A for onion, sugarbeet, and tomato.Page 51 of 125



## 5 .0 Risk Chara cterization

Risk characterization is the integration of exposure and effects characterization to determine the potential for ecological risks to non

- target organisms including aquatic life, wildlife, and plants from the use of tolfenpyrad according to the proposed labels. The risk characterization provides an estimation and description of the risk; articulates risk assessment assumptions, limitations, and uncertainties; synthesizes an overall conclusion; and provides the risk managers with

information to ma ke regulatory decisions.

5.1 Risk Estimation Process: Integration of Exposure and Effects Data

Results of the exposure and toxicity effects data are used to evaluate the potential for adverse ecological effects on non

- target species. For the assessment of potential risks of tolfenpyrad (technical grade active ingredient), the risk quotient (RQ) meth od is used to compare exposure and measured acute or chronic toxicity reference values:

RQ = EEC / Toxicity Reference Value

where: EEC is the estimated environmental concentration generated by the exposure scenarios. The RQs are compared to the Agency’s levels of concern (LOCs). These LOCs are the Agency’s interpretive policy and are used to analyze potential risk to non

- target organisms and the need to consider regulatory action (see Appendix H ). These criteria are used to indicate when a pesticide’s use as directed on the label has the potential to cause adverse effects on non

- target organisms.

5.1.1 Non

- target Aquatic Fish, Invertebra tes, and Plants

Peak EECs were compared to definitive acute toxicity endpoints to derive acute risk quotients.

The 21

- day EECs were compared to chronic toxicity endpoints (NOAEC values) to derive chronic risk quotients for invertebrates. The 60

- day EECs we re compared to chronic toxicity endpoints (NOAEC values) to derive chronic risk quotients for fish. Peak EECs were compared

to EC 50 

### values for aquatic plants to calculate risk quotients for non

- listed species and NOEC values to calculate risk quotients for listed plant species . The following risk estimations apply to

TGAI toxicity endpoints.

A summary of the risk quotients for freshwater fish and aquatic invertebrates is presented in

Table 5.1

. For freshwater fish, acute RQ values range from 0.7 to 17 an d exceed the acute risk to listed species LOC of 0.05 (and the non

- listed species LOC of 0.5) for all 2 2 exposure scenarios assessed. Chronic RQ values for freshwater fish range from 0.0 5 to 3.6 and exceed the

chronic risk to listed and non

- listed species LOC of 1.0 for 9 of the 2 2 exposure scenarios assessed. For freshwater aquatic invertebrates, acute RQ values range from 0.1 to 2. 8 and exceed the acute risk to listed species LOC (0.05) and non

- listed species LOC (0.5) in 2 2 and 1 1 exposure scenarios, respectively. Chronic risks to freshwater invertebrates are evident in 10 of

the 2 2 exposure scenarios where RQ values meet or exceed the LOC of 1.0 and range from 0.04

to 3.6

.Page 52 of 125



### Table 5.1 Risk q uotients f reshwater fish and invertebra tes

.

Scenario/

Peak EEC FW Fish Acute RQ FW

Invertebrate

Acute RQ FW

Invertebrate

Chronic RQ FW Fish Chronic

RQ Aerial Application

CA citrus

- 150 ft buffer ( 0.21 ppb ) 1.3 0.2 2.9 0.26

FL citrus

- 150 ft buffer ( 0.78 ppb ) 4.8 0.8 1.0 1.2

TX cotton ( 2.68 ppb ) 1 7 2.7 2.7 2.5

CA cotton ( 0.20 ppb ) 1.2 0.2 0.3 0.1

CA tomatoes ( 0.17 ppb ) 1.0 0.17 0.25 0.2

CA lettuce ( 0.11 ppb ) 0.7 0.1 0.45 0.4

FL ca bbage ( 0.8 ppb ) 4.8 0.8 0.16 0.1
ID potato ( 0.31 ppb ) 1.9 0.3 0.45 0.5 Airblast Application NC apple ( 1.62 ppb ) 10 1.6 2. 3 2.2 PA apple ( 1.24 ppb ) 7.6 1.2 1.9 2.2 OR apple ( 0.85 ppb ) 5.2 0.8 1. 5 1.5

CA citrus ( 0.48 ppb ) 2.9 0.5 0.6 0.05

FL citrus ( 0.19 ppb ) 1.2 0.2 1.3 1.5 GA peach ( 0.14 ppb ) 0. 9 0.1 1.3 1.2 GA p ecan ( 1.44 ppb ) 8.8 1.4 1.6 1.7

Ground Application: Ground Boom, Air Curtain Sprayers, or other method
MS Cotton (2.8 ppb) 

### 17 2.8 3.6 3.6

FL cucumber ( 0.55 ppb ) 3.4 0.5 0.7 0.8

CA t omato ( 0.13 ppb ) 0.8 0.1 0.16 0.16

CA g rapes (0.17 ppb) 1.0 0. 17 0.40 0.2

FL c abbage ( 0.8 ppb ) 4.8 0.8 0.45 0.7

CA l ettuce ( 0.21 ppb ) 1.3 0.2 0.04 0.4 ID potato (0.3 ppb) 1. 8 0.3 0.4 0.4
RQ values in bold exceed the acute risk to listed species LOC of 0.05 or chronic risk LOC of 1.0.

Acute RQ values for freshwater fish and invertebrates are based on an LC 50 = 0.163 ppb a nd 1.0 ppb, respectively. Chronic RQ values for freshwater fish and invertebrates are based on a 60

- d NOAEC of 0.188 ppb and 21

- d NOAEC of 0.224 ppb, respectively.



### A summary of the risk quotients for estuarine/marine fish and aquatic invertebrates is presented

in Table 5. 2

. For estuarine/marine fish, acute RQ values range from 0. 03 to 0.8 3 and meet or exceed the acute risk to listed species LOC (0.05) and the non

- listed species LOC (0.5) for 1 8

and 2 of the 2 2 exposure scenarios assessed, respectively. Chronic RQ values for

estuarine/marine fish range from 0.0 5 to 2. 5 and exceed the chronic risk to listed and non

- listed species LOC of 1.0 for 9 of the 2 2 exposure scenari os assessed. For estuarine/marine aquatic invertebrates, acute RQ values range from <0.014 to <0.3 6 . These acute RQ values are expressed as “less than” values because a definitive E C 50 

### was not reached in the acute test for the most acutely sensitive estu arine/marine invertebrate species tested ( EC 50 

### was > 7.8 ppb). Therefore, only the upper bounds of the acute RQ values can be defined, assuming that the EC 50 

### was actually 7.8 ppb. Based on the upper bound of the acute RQ values, 10 of the 2 2 acute RQ

valu es could potentially exceed the acute risk to listed species LOC (0.05) and none exceed thePage 53 of 125



### acute risk to non

- listed LOC of 0.5. However, the upper bound of these acute RQ values is relatively close to the listed species LOC of 0.05 (most are within a fac tor of 3). No c hronic

risks to estuarine/marine invertebrates are evident as none of the 2 2 exposure scenarios assessed resulted in RQ values that exceeded the LOC (1.0).

Table 5. 2

. Risk Quotients for e stuarine/ m arine fish and invertebrates

Scenario/

Peak EEC Est/Mar. Fish

Acute RQ Est/Mar.

Invertebrate

Acute RQ Est/Mar.

Invertebrate

Chronic RQ Est/Mar.

Fish Chronic RQ Aerial Application

CA citrus

- 150 ft buffer (0.21 ppb) 0.06 <0.027 0.03 0.26

FL citrus

- 150 ft buffer ( 0.78 ppb) 0.23 < 0.10 0.11 1.2 TX cotton ( 2.68 ppb) 0.80 <0.35 0.29 2.5 CA cotton ( 0.20 ppb) 0.06 <0.03 0.03 0.1 CA tomatoes ( 0.17 ppb) 0.05 <0.02 0.07 0.2

CA lettuce ( 0.11 ppb) 0.03 <0.014 0.05 0.4

FL c abbage ( 0.8 ppb) 0.24 <0.10 0.017 0.1
ID potato (0.31 ppb) 0.09 <0.04 0.05 0.5 Air Blast Application NC apple ( 1.62 ppb) 0.48 <0.21 0.24 2.2 PA apple ( 1.24 ppb) 0.37 <0.16 0.2 2.2 OR apple ( 0.85 ppb) 0.25 <0.11 0.16 1.5 CA citrus ( 0.48 ppb) 0.14 <0.06 0.06 0.05 FL citrus ( 0.19 ppb) 0.14 <0.03 0.14 1.5 GA peach ( 0.14 ppb) 0.04 <0.018 0.14 1.2

GA p ecan ( 1.44 ppb) 0.42 <0.18 0.17 1.7

Ground Application: Ground Boom, Air Curtain Sprayers, or other method

MS Cotton (2.8 ppb) 

### 0.83 < 0.36 0.38 1.7
FL cucumber ( 0.55 ppb) 0.16 <0.07 0.08 0.8 CA tomato ( 0.13 ppb) 0.04 <0.02 0.017 0.16 CA grapes (0.17 ppb) 0.05 <0.02 0.026 0.2 FL cabbage ( 0.8 ppb) 0.23 <0.10 0.05 0.7

CA lettuce (0.21 ppb) 0.06 <0.03 0.04 0.4 ID potato (0.3 ppb) 0.09 <0.04 0.04 0.4
RQ values in bold exceed the acute risk to listed species LOC of 0.05 or chronic risk LOC of 1.0. Acute RQ values for estuarine/marine fish and invertebrates are based on an LC 50 = 3.38 ppb for sheepshead minnow

and an EC 50 of >7.8 ppb for eastern oyster , respectively. Chronic RQ values for estuarine/marine fish and

invertebrates are based on a 60

- d NOAEC of 0.18 6 ppb for sheepshead minnow and 2 8

- d NOAEC of 2.3 ppb for mysid shrimp , respectively.



### Risk quotients for aquatic plants are provided in Table 5. 3 . For non

- listed and listed vascular aquatic plants, risk quotients do not exceed the LOC of 1.0. The risk quotients are expressed as “less than” values for listed aquatic plants because the EC 50 

### upon which they are based was non

definitive (> 30 ppb). For non

- vascular aquatic plants, RQ values range from 0.1 to 2. 8 for non

listed species and 0.1 to 5. 6 for listed species, indicating risk to non

- vascular plants for selected crop exposure scenarios.Page 54 of 125



### Table 5.3

. Risk quotients for vascular and non

- vascular aquatic plants

Scenario/

Peak EEC Vascular aquatic plant RQ Listed

Vascular Aquatic Plant RQ Non

- Vascular

Aquatic plant RQ Listed Non

Vascular Plant RQ

Aerial Application

CA citrus

- 150 ft buffer (0.21 ppb) <0.006 0.006 0.2 0.4

FL citrus

- 150 ft buffer ( 0.78 ppb) <0.026 0.026 0.8 1.5 TX cotton ( 2.68 ppb) <0.089 0.089 2.7 5.4 CA cotton ( 0.20 ppb) <0.006 0.006 0.2 0.4 CA tomatoes ( 0.17 ppb) <0.006 0.006 0.2 0.3

CA lettuce ( 0.11 ppb) <0.003 0.003 0.1 0.2 FL cabbage ( 0.8 ppb) < 0.026 0.026 0.8 1.6 ID potato (0.31 ppb) < 0.01 0.01 0.3 0.6
Airblast Application NC apple ( 1.62 ppb) < 0.054 0.054 1.6 3.2 PA apple ( 1.24 ppb) < 0.04 0.04 1.2 2.5 OR apple ( 0.85 ppb) < 0.026 0.026 0.8 1.7 CA citrus ( 0.48 ppb) < 0.016 0.016 0.5 1.0 FL citrus ( 0.19 ppb) < 0.006 0.006 0.2 0.4 GA peach ( 0.14 ppb) < 0.005 0.005 0.1 0.3 GA pecan ( 1.44 ppb) < 0.05 0.05 1.4 2.9 Ground Application
MS Cotton (2.8 ppb) 

### <0.09 0.09 2.8 5.6 FL cucumber ( 0.55 ppb) < 0.018 0.018 0.5 1.1 CA tomato ( 0.13 ppb) < 0.004 0.004 0.1 0.3 CA grapes (0.17 ppb) < 0.006 0.006 0.17 0.3 FL cabbage ( 0.8 ppb) < 0.026 0.026 0.8 1.6

CA lettuce (0.21 ppb) < 0.006 0.006 0.2 0.4 ID potato (0.3 ppb) < 0.01 0.01 0.3 0.6
RQ values for vascular aquatic plants determined using an EC 50 of > 30 ppb (non

- listed) and NOAEC of 30 ppb (listed). RQ values for non

- vascular aquatic plants determined using an EC50 of 1.0 ppb (non

- listed) and 0.50 ppb (listed). RQ values in bold exceed the LOC of 1.0 for plants.



### 5.1.2 Non

- target Terrestrial Animals (Terrestrial Diet)

Birds

For the technical grade active ingredient, the lowest acute oral toxicity endpoint was an E D 50 

### of

5 8 mg a.i./kg bw for the zebra finch and a dietary LC 50 

### of 1348 ppm based the bobwhite quail

.

Avian acute RQ values are shown in Table 5. 4 for each proposed application scenario. Considering all the size classes and dietary categories, acute oral and diet

- based RQ values rangePage 55 of 125



### from <0.01 to 2.5

. On an acute dietary basis, only 1 RQ value meets or e xceeds the avian acute risk to endangered species LOC of 0.1 (curcurbits, short grass). On a n acute dose basis, acute RQ values exceed the endangered species LOC (0.1) for all exposure scenarios assessed and for most of the food items for small (20g)

, med ium (100g) , and large (1000g) size birds. Acute oral RQ values exceed ed the acute risk to non

- listed avian LOC (0.5) for most dietary categories for small birds (20g) and primarily just for short grass and broadleaf plants for medium size birds (100g). N one of the acute oral RQ values exceeded the acute risk to non

- listed species L OC (0.5) for large birds (1000g).

Table 5. 4 Avian Acute Dietary or Oral Dose

- Based Risk Quotients
Feeding Category Dietary RQ Dose

- Based RQ

Small (20 g) Medium

(100 g) Large

(1000 g) Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear, oriental pear, s tone

fruit and tree nuts 2 apps @ 0.27 lb a.i./acre (14

- day interval) Short grass 0.08 2.1 0.9 3 0.29 Tall grass 0.04 0.9 5 0.4 3 0.13 Broadleaf plants 0.05 1.2 0.5 2 0. 17 Fruits/pods 0.01 0.1 0.06 0.02 Arthropods 0.03 0.81 0.36 0.12

Seeds 0.01 0.03 0.01 <0.01

Cucurbits (4 apps at 0.21 lb a.i./ A, 14

- d interval) Short grass 0.10 2.5 1.1 0.36 Tall grass 0.05 1. 2 0.52 0.17 Broadleaf plants 0.06 1.4 0.64 0.20 Fruits/pods 0.01 0.16 0.07 0.02 Arthropods 0.04 0.99 0.44 0.14

Seeds 0.01 0.04 0.02 0.01 Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton (2 apps at 0.21 lb a.i./ A,

14

- d interval) Short grass 0.07 1.6 0.72 0.23

Tall grass 0.03 0.74 0.33 0.10 Broadleaf plants 0.04 0.91 0.41 0.13 Fruits/pods <0.01 0.10 0.05 0.01 Arthropods 0.03 0.63 0.28 0.09

Seeds <0.01 0.02 0.01 <0.01

Acute avian diet and dose

- based RQ values are based on EEC estimates ( Table 3.6 ) and a dietary LC 50 of 1348 ppm (bobwhite quail) and a n acute oral ED 50 of 58 mg ai/ k g bw (zebra finch) , respectively. Acute RQ values shown in

bold meet or exceed the acute risk to listed species LOC of 0.1.



### Chronic risk quotients for birds could not be expressed on a definitive basis because a NOAEC was not reached in the avian reproductive study with the most sensitive species tested (LOAEC = 9.7 ppm at the lowest test concentration for egg laying)

. Therefore, in order to determine if the avian chronic LOC of 1.0 is exceeded by the proposed uses, non

- definitive (“greater than”) RQ values were calculated using a NOAEC of <9.7 ppm in the diet. These “greater than” RQ values provide the lower bound of the chronic RQ and can be used to determin e if the chronic LOC is

exceeded (but not precisely by how much it is exceeded) . Results from this comparison are provided in Table 5.5 and range from >0.6 to >14. 4

. These non

- definitive RQ values indicate the potential for chronic risk to avian species for all assessed uses and dietary categories except possibly fruits and pods. Given the proximity of the non

- definitive RQ for fruits and pods to thePage 56 of 125



### LOC of 1.0 in combination with the use of a LOAEC to calculate the RQ value, there is reasonable potenti al for chronic risks to occur if a definitive NOAEC was available from the avian reproduction study.

Table 5. 5 Avian Chronic Avian Diet

- Based Risk Quotients

Diet Category Chronic RQ Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear,

oriental pear, stone fruit and tree nuts (2 apps @ 0.27 lb a.i./acre 14

- day interval)

Short grass > 11.7

Tall grass > 5.4 Broadleaf plants > 6.6 Fruits/pods > 0.7 Arthropods >4. 6

Cucurbits (4 apps at 0.21 lb a.i./A, 14

- d interval) Short grass > 14.4 Tall grass > 6.6 Broadleaf plants > 8 .1 Fruits/pods > 0.9 Arthropods > 5.6 Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton (2 apps

at 0.21 lb a.i./A, 14

- d interval) Short grass > 9.1 Tall grass > 4.2 Broadleaf plants > 5 .1 Fruits/pods > 0.6 Arthropods > 3.6

Chronic avian diet

- based RQ values are based on EEC estimates ( Table 3. 6 ) and a dietary NOAEC of < 9.7 ppm, which yield non

- definitive (“>”) RQ values

. The chronic RQ values shown in bold exceed the avian chronic risk to

listed and non

- listed species LOC of 1

.



### Mammals

Acute risk quotients for mammals were calculated using the acute oral rat study submitted for the technical grade active ingredient. Acute dose

- based mammalian RQs are show n in Table 5. 6 for all proposed use scenarios. Considering all the size classes and dietary categories, acute dose

based RQ values range from <0.01 to 0. 25 , which indicates that none exceed the acute risk to

non

- listed species LOC of 0.5 for mammals. Mam malian acute RQ values generally exceeded the acute risk to listed species LOC (0.1) for short grass, tall grass, and broadleaf plants for small (15g) and medium (35g) size mammals; however, the RQ values were within a factor of two of

this LOC.Page 57 of 125



### Table 5. 6 . Acute mammalian dose

- based risk quotients

Feeding Category Dose

- based Risk Quotients

Small (15 g) Medium

(35 g) Large

(1000 g) Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear, oriental pear , s tone fruit and

tree nuts 2 apps @ 0.27 lb a.i./acre (14

- day interval) Short grass 0.21 0.18 0.09 Tall grass 0.09 0.08 0.04 Broadleaf plants 0.12 0.10 0.05 Fruits/pods 0.01 0.01 0.01 Arthropods 0.08 0.07 0.04

Seeds <0.01 <0.01 <0.01

Cucurbits 4 apps @ 0.21 lb a.i./acre (14

- day interval) Short grass 0.25 0.22 0.12 Tall grass 0.12 0.10 0.05 Broadleaf plants 0.14 0.12 0.07 Fruits/pods 0.02 0.01 0.01 Arthropods 0.10 0.08 0.05

Seeds <0.01 <0.01 <0.01

Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton

2 apps @ 0.21 lb a.i./acre (14

- day interval) Short grass 0.16 0.14 0.07 Tall grass 0.07 0.06 0.03 Broadleaf plants 0.09 0.08 0.04 Fruits/pods 0.01 0.01 0.00 arthropods 0.06 0.05 0.03

Seeds <0.01 <0.01 <0.01

Acute mammalian dose

- based RQ values are based on EEC estimates ( Table 3. 7 ) and an acute oral LD 50 of 239 mg/kg bw for the laboratory rat. RQ values shown in bold exceed the mammalian acute risk to listed species LOC

of 0. 1

.



### I n the submitted one

- generation rat reproduction study with dietary t olfenpyrad exposure, the NOAEL was 0.86 mg a.i./kg

- bw/day for males. Chronic RQs are shown in Table 5.5 below. Considering all of the crop scenarios and dietary categories, chronic mammalian RQ values range from 0. 37 to 70.4

. Chronic risk to mammals (sma ll, medium and large) is indicated for all crop exposure scenarios modeled and for all dietary categories except seeds.

Table 5.5. Chronic mammalian dietary and dose

- based risk quotients

Feeding Category Dietary

- based Risk Quotients Dose

- based Risk Quotients

Small (15 g) Medium

(35 g) Large

(1000 g) Citrus fruit, grapes, apples, crabapples, loquat, mayhaw, quince, pear, oriental pear, s tone fruit and

tree nuts ( 2 apps at 0.27 lb a.i./acre

, 14

- day interval) Short grass 7. 6 57. 5 49. 1 26.3

Tall grass 3. 5 26.3 22.5 12. 1 Broadleaf plants 4. 3 32.3 27.6 14.8 Fruits/pods 0.47 3. 6 3. 1 1.6 Arthropods 3.0 22.5 19.2 10.3

Seeds 0.47 0.80 0.68 0.37

Cucurbits ( 4 apps at 0.21 lb a.i./acre

, 14

- day interval)Page 58 of 125

Feeding Category Dietary

- based Risk Quotients Dose

- based Risk Quotients

Small (15 g) Medium

(35 g) Large

(1000 g) Short grass 9.3 70. 4 60.1 32.2 Tall grass 4. 3 32. 3 27. 6 14. 8 Broadleaf plants 5. 2 39. 6 33.8 18.1 Fruits/pods 0.58 4.4 3. 8 2.0 Arthropods 3.6 27.6 23.5 12.6

Seeds 0.58 0.98 0.83 0.45 Leafy vegetables, potatoes, Brassica, fruiting vegetables and cotton ( 2 apps @ 0.21 lb a.i./acre

14

- day interval) Short grass 5.9 44. 7 38.2 20. 5 Tall grass 2.7 20. 5 17.5 9. 4 Broadleaf plants 3.3 25.1 21. 5 11.5 Fruits/pods 0.37 2. 8 2. 4 1. 3 Arthropods 2.3 17.5 15.0 8.0

Seeds 0.37 0.62 0.53 0.28

Chronic mammalian diet

- based RQ values are based on EEC estimates ( Table 3. 7 ) and a dietary NOAEL of was 0 .86 mg a.i./kg

- bw/day (15 ppm diet) for male rats. The chronic RQ values shown in bold exceed the mammalian

chronic risk to listed and non

- listed species LOC of 1

.



### 5.1. 3 Non

- target Terrestrial Animals (Aquatic Prey)

Results from the KABAM aquatic bioaccumulation assessment regarding the potential for risks to piscivorous mammals and birds are shown in Table 5.6 for the crop exposure scenario producing the highest EECs (TX Cotton). Complete model results, input param eters and intermediate calculations are provided in Appendix E . As indicated below, the potential for chronic risks to piscivorous wildlife is indicated for three representative mammal feeding guilds (fog/water shrew, rice rate/star

- nosed mole, and small river otter) and is very close to the chronic LOC of 1.0 for the remaining representative mammalian species. Risks to piscivorous birds are not indicated; however it is noted that the chronic NOAEC used was < 9.7 ppm (diet) based on

the LOAEL from the avi an reproduction study. Therefore, chronic risks to piscivorous birds may be indicates should the actual NOAEL be lower than the LOAEL by approximately a factor

of two.

Table 5. 6. Calculation of RQ values for mammals and birds consuming fish contaminated by Tolfenpyrad (TX Cotton).

Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

Mammalian fog/water shrew 0.010 N/A 2.8 0.50

rice rat/star

- nosed mole 0.008 N/A 2.3 0.34

small mink 0.003 N/A 0.87 0.14 large mink 0.003 N/A 0.96 0.14

small river otter 0.004 N/A 1.0 0.14 large river otter 0.003 N/A 0.80 0.10

Avian sandpipers 0.095 0.004 N/A > 0.60

cranes 0.005 0.004 N/A > 0.57

rails 0.045 0.004 N/A > 0.61Page 59 of 125



### Wildlife Species Acute Chronic

Dose Based Dietary Based Dose Based Dietary Based

herons 0.007 0.004 N/A > 0.56 small osprey 0.004 0.002 N/A > 0.25 white pelican 0.001 0.001 N/A > 0.18



### 5.1.4 Terrestrial and Semi

- aquatic Plants

Terrestrial and semi

- aquatic plants may be exposed to pesticides from runoff and spray drift.

Semi

- aquatic plants are those that inhabit low

- lying wet areas that may be dry at certain times of the year. EECs for terrestrial and semi

- aquatic plants are derived for areas adjacent to the treatment site. Acute RQs for terrestrial plants are derived by dividing the EEC by the EC 25 

### from seedling emergence and vegetative vigor toxicity tests. Acute RQs for listed plant species are calculated by dividing the EEC by the NOAEC (if not available, an EC 05 

### is used) value from toxicity tests.

Terrestrial plant EECs and toxicity endpoints are provided in Tables 3. 11 and 4.7 , respectively. Because no inhibitory effects greater than 25% were observed in either the vegetative vigor or seedling emergence studies with tolfenpyrad 15% SC, RQs were not calculated for non

- listed species. For listed species of monocots, the NOAEC of 0.265 lbs a.i./acre was used to calculate RQs. For listed species of dicots, a NOAEC of 0.265 lbs a.i./acre derived from the submitted vegetative vigor study was used to calculate the potential risk from spray drift exposure only. TerrPlant v1.2.2 ( Appendi x C ) and risk quotient ( RQs ) are summarized in Table 5. 7

.

Based on a single application

, n one of the RQs exceeded the LOC for listed terrestrial plant s.

Table 5. 7 . Tolfenpyrad (RQ) values for plants in dry and semi

- aquatic areas

Plant Type Listed Statu s Dry Semi

- Aquatic Spray Drift Only

Monocot Listed <0.1 <0.1 <0.1

Dicot Non

- listed <0.1 <0.1 <0.1

Dicot Listed Could not be

determined Could not be

determined <0.1 * Based on the maximum proposed application rate

– 0.2 7 lbs a.i./acre. Aerial and ground spray application scenarios resulted in no differences in risk quotient calculations.



### 5.1.5 Non

- Target Insect Pollinators

In September 2012, the USEPA Office of Pesticide Programs published its draft Pollinator Risk Assessment Framework for review by the FIFRA Scientific Advisory Panel. 1 

### In this framework, a tiered approach is used for assessing risks to bees from different routes of exposure to pesticides (direct contact via interception of spray droplet and oral exposure via consumption of

contaminated pollen and nectar). For tolfenpyrad, both contact and oral routes of exposure are relevant since it is proposed for aerial application to crops with no proposed restriction of

1 

### http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2012

- 0543

- 0004Page 60 of 125



### application during blooming periods of crops. As risks are identified in lowe r tiers, additional refinements and data are considered in higher tiers.

Tier 1 of the draft risk assessment framework consists of a screening

- level assessment that requires minimal data but is conservative in the estimation of potential exposure. For di etary

exposure to pesticides , the Tier 1 approach uses the upper

- bound residue for tall grass predicted by the T

- REX model (v. 1.5.1). This is the same model used for establishing screening

- level exposures to terrestrial vertebrates. The upper bound resi due predicted for tall grass (110 mg a.i./kg per lb a.i./A) is considered a reasonably conservative estimate of the upper bound residues of pesticides in pollen and nectar , as detailed in the Agency’s Risk Assessment Framework White Paper . This upper boun d residue value is then converted to a dietary dose received by adult and larval worker bees using pollen and nectar consumption rates for these two life stages, which are 292 and 120 mg/day, respectively

. These consumption estimates represent central

te ndency estimates for the caste of honey bees which are expected to be experience the greatest exposure via the dietary route. Consequently, the dietary based exposure value for larvae is 13 μg a.i./bee per 1 lb a.i./A and the value for adults is 32 μg a.i ./bee per 1 lb a.i./A. Estimated pesticide exposure values are then scaled to a pesticide

- specific application rate by multiplying by the application rate. Finally, the pesticide

- specific dietary exposure estimate is divided by

the acute oral LD 50 

### to det ermine the acute oral RQ. This acute RQ is compared to an acute risk LOC of 0.4 determined specifically for honey bees.

In order to quantify contact exposures due to direct spray, the proposed upper bound value is 2.7 μg a.i./bee per 1 lb a.i./A . This v alue is based on data published by Koch and Weisser 1997 , who measured residues on bees following a series of spray applications

. As with oral exposure, the dose per bee on a 1 lb a.i./A basis is scaled to a pesticide

- specific application rate by multiply ing by the application rate. The acute contact RQ is determined by dividing this scaled pesticide contact dose by the acute contact LD 50 

### and compared to the same LOC of 0.4 for identifying

acute risk concerns.

Results from the Tier 1 acute oral and conta ct screening risk assessment are provided in Table

5.8 . Since the Tier 1 acute RQ values exceed the acute risk LOC of 0.4, the potential for acute risk to honey bees is identified. These results indicate that additional refinements to the Tier 1

risk asse ssment may be appropriate, including use of chemical

- specific residues on pollen and nectar and possibly consideration of exposure and effects at the whole colony level (Tier 2 assessment). They also indicate that practices to mitigation exposure to bees (e.g., restricting application during bloom for oral exposure) may be necessary to reduce acute risk to bees.Page 61 of 125



### Table 5.8 . Tier 1 acute contact and dietary risk quotients for honey bees

Life
Stage Exposure Type Dose ( μ g a.i./bee per 1 lb a.i./A) (1) Tolfenpyrad Dose

for Max Application

Rate ( μ g a.i./bee

per 0. 27 lb a.i./A) Acute

RQ) (2 ) (3) Chronic

RQ) ( 3)

Adult Diet (nectar + pollen) 32 8.64 23 n.a.

Adult Direct contact 2.7 0.729 1.6 n.a.

(1 ) Source: USEPA 2012. Draft Pollinator Risk Assessment Framework

(2) Based on a 48

- h acute contact LD 50 of 0. 47 μ g ai/bee for TGAI and acute oral LD 50 of 0.37 μ g ai/bee

for TGAI ( M RID 48250432 )

. ( 3 ) Bolded value exceeds the acute risk LOC of 0.4



### 5.2 Risk Description

A screening

- level risk assessment, based on the proposed uses of tolfenpyrad, suggests that predicted levels of tolfenpyrad in the environment, when compared with the most sensitive toxicity values for a given taxa, may result in direct advers e effects to birds, mammals, fish, aquatic invertebrates and nonvascular aquatic plants. Risks to aquatic vascular plants and terrestrial plants are below Agency levels of concern. Tolfenpyrad is also highly toxic to non

target pollinator insects and poss ibly other terrestrial invertebrates from contact, ingestion or foliar residue exposures. The following discussion is intended to characterize the previous risk estimation of tolfenpyrad in the context of all available information and considers the sensit ivity and uncertainty associated with the risk estimation methods and available data.

5.2.1 Risks of Tolfenpyrad to Aquatic Organisms

T he Tier II model Pesticide Root Zone Model (PRZM v3.12.2) linked with EXposure Analysis Modeling System (EXAMS v2.98.4. 6) via the model shell PRZM/EXAMS (PE v5.0, Nov. 15, 2006) was run to estimate baseline

- level exposures for grape scenario. The PRZM model simulates pesticide movement and transformation on and across the agricultural field resulting from crop applications . The EXAMS model simulates pesticide loading via runoff, erosion, and spray drift assuming a “standard” 1

- ha pond, 2

- m deep (20,000 m 3 

### ) with no outlet that borders a

10

- ha treated field. Simulations are run for multiple (usually 30) years, and the Agenc y estimates peak and running mean values that are expected once every ten years based on the daily values generated during the simulation. The coupled PE models and users manuals are available from the U.S. Environmental Protection Agency Water Models web

- page (U.S. EPA, 2011).

Exposure estimates generated using this “standard” pond are intended to represent a wide variety of vulnerable water bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetlands, vernal pools, man

- m ade and natural ponds, and intermittent and first

- order streams. As a group, there are factors that make these water bodies more or less vulnerable than the standard surrogate pond. Static water bodies that have larger ratios of pesticide

- treated drainag e area to water body volume would be expected to have higher peak EECs than the standard pond. These water bodies will be either smaller in size or have large drainage areas. Smaller water bodies have limited storage capacity and thus may overflow and ca rry pesticide in the discharge, whereas the standard pond has no discharge. As watershed size increases, itPage 62 of 125



### becomes increasingly unlikely that the entire watershed is planted with a non

- major single crop that is all treated simultaneously with the pestici de. Headwater streams can also have peak concentrations higher than the standard pond, but they likely persist for only short periods of time and are then carried and dissipated downstream . The surface water and pore water EECs calculated for aquatic org anism risk assessment are provided in Tables 3.4 and 3.5

. A discussion of the risk assessment for various taxonomic groups of aquatic organisms is provided below.

Fish and Aquatic

–

Phase Amphibians

The potential for acute risks to listed and non

- listed freshwater and estuarine/marine fish is indicated for the proposed uses of tolfenpyrad. Specifically, acute RQ values for freshwater fish (r ange : 0.7

- 17 ) exceed the acute risk to listed and non

- liste d species LOC of 0. 0 5 and 0.5, respectively, for all 22 crop exposure scenarios modeled. These RQ values are based on 1 in 10

year peak EECs for tolfenpyrad that range from 0.11 and 2.8 μg a.i./L , respectively and an acute

LC 50 

### of 0.1 63 μg a.i./L for rain bow trout exposed to TGAI (the most acutely sensitive of the three species tested). In considering the acute LC 50 

### values for the other two freshwater fish species (0.94 and 3.2 μg a.i./L for bluegill and carp, respectively), the range in acute sensitivity for tested freshwater fish is about 30X. However, acute risk would still be expected for some exposure scenarios even with these less acutely sensitive fish species. For estuarine/marine fish, the magnitude of the acute RQ values are lower than those fo r freshwater fish (range: 0.03

- 0.83 ) due the lower sensitivity of the single tested species (sheepshead minnow; LC 50 

### = 3.38 μg a.i./L ). These acute RQ values exceeded the acute risk to listed and non

- listed species LOC of 0.05 and 0.5, respectively, in 18 and two of the 22 crop exposure scenarios modeled. The crop exposure scenarios that yield the highest acute risk potential to fish include TX cotton, NC apple, PA apple OR apple, GA pecan, and MS cotton, with acute RQs exceeding the acute risk to FW fish LOC of 0.5 by 10X or higher. It is noted that all EECs determined for aerial app lication include a

150ft buffer.

The potential for chronic risk to freshwater and estuarine/marine fish from the proposed uses of tolfenpyrad is also indicated for 9 of the 22 crop exposure scenarios modeled for each taxonomic

group. Chronic RQ values range from 0.0 5 to 3.6 for freshwater fish and from 0.05 to 2.5 for

estuarine/marine fish. It is worthy to note that the chronic early life stage NOAEC for freshwater fish (0. 188 μg a.i. with fathead minnow ) is actually somewhat higher than the 96

- h LC 50 

### of 0.114 μg a.i./L for rainbow trout. The reason for this similarity between the acute and chronic endpoints for freshwater fish is not known with certainty, but is likely related to different species upon which the acute and chronic toxicity endpoints are based. It is not ed that rainbow trout are more acutely sensitive than warm water fish (bluegill, carp) by 9X and 30X, respectively. Therefore, it is reasonable to expect that if the chronic toxicity of tolfenpyrad were also determined on rainbow trout, a lower NOAEC woul d have been achieved. Another possible reason for this similarity in acute and chronic toxicological endpoints may relate to the study limitations associated with the chronic NOAEC of 0.188 μg a.i./L with fathead minnow. Specifically, results from growth measurements were deemed unreliable for that study and the NOAEC was based on survival only (see Section 4.1). However, the freshwater fish full life cycle NOAEC for the same species (0.189 μg a.i./L based on reductions in survival) was nearly

identical to the ELS NOAEC (0.188 μg a.i./L). Furthermore, a nearly identical NOAEC wasPage 63 of 125



### observed with the sheepshead minnow (0.186 μg a.i./L based on reductions in growth). All three chronic toxicity studies were based on total radioactive residues (TRR) and did n ot directly measure parent chemical in exposure solutions. As a result, it is possible that actual freshwater and estuarine/marine NOAEC values for parent tolfenpyrad may be lower than those based on TRR if parent chemical was undergoing degradation durin g the study. As discussed previously in Section 4.1, the toxicity of the major transformation products of tolfenpyrad to freshwater fish ( PCA, PC

- TA, PT(A)

- 4OH and PAM ) was three orders of magnitude less than parent tolfenpyrad.

Aquatic Invertebrates

Th e potential for acute risks to listed and non

- listed freshwater invertebrates is indicated for the proposed uses of tolfenpyrad. Specifically, freshwater invertebrate acute RQ values range from

0.1 to 2. 8 and exceed the acute risk to listed species LOC (0 .05) and non

- listed species LOC (0.5) in 22 and 11 exposure scenarios, respectively. For estuarine/marine invertebrates, a potential for acute risk to listed invertebrates was identified (RQ range: <0.014 to <0.3 6)

. However, acute risks to non

- listed inve rtebrates were not evident since acute RQ values were

below the non

- listed species LOC of 0.5. The potential for acute risk to listed estuarine/marine invertebrates is much less certain compared to freshwater invertebrates because the acute EC50 value upo n which the estuarine/marine RQ values are based is a non

- definitive value (> 7.8 μg a.i./L for eastern oyster). Thus, only the upper bound of the acute RQ values could be determined by basing it on the maximum concentration tested in this study (7.8 μg a .i./L). At the highest and second most highest test concentrations, 37 % and 44% inhibition in shell deposition occurred. These observations suggest that the actual EC 50 

### value may be relatively close to the highest test concentration of 7.8 μg a.i./L. For mysid shrimp, the EC 50 

### was > 12 μg a.i./L.

Chronic risks to freshwater invertebrates are evident in 10 of the 22 exposure scenarios where RQ values meet or exceed the LOC of 1.0 and range from 0.04 to 3.6

. These chronic RQ values

are based NOAEC of 0 .244 μg a.i./L determined for reproductive effects on the cladoceran, D.

magna

. Furthermore, chronic EECs exceed the LOAEC of 0.482 μg a.i./L from this study, with reflects the onset of significant reductions in the number of offspring. For estuarine/mar ine invertebrates, chronic risks were not evident for any of the 22 exposure scenarios evaluated.

For freshwater benthic invertebrates, a pore water NOAEC of 0.0288 μg a.i./L was determined

for a 28

- d exposure of the midge, C. riparius . Importantly, no significant adverse effects on emergence or development rate were observed in any exposure concentration tested in this study. Furthermore, effects on reproduction were not included, which is required for USEPA chronic life cycle sedime nt toxicity testing. All but four of the 21

- d EECs in pore water (Table 3.5) exceed this unbounded NOAEC of 0.0288 μg a.i./L, with the maximum EEC exceeding by a factor of 10. Therefore, there is a potential for chronic risks to benthic aquatic invertebr ates for the proposed tolfenpyrad uses; however, risk estimation is highly uncertain due to the aforementioned limitations of the sediment toxicity study.Page 64 of 125 

### Aquatic Plants

The submitted tolfenpyrad technical study for Lemna gibba indicates that tolfenpyrad is not toxic aquatic vascular plants up to the highest concentration tested, 30 μg a.i./L (MRID 48250436 ). As a result, risk quotients do not exceed the LOC of 1.0 f or non

- listed and listed vascular aquatic pla nts and the potential risk to aquatic vascul ar plants is considered low

. It is noted that the

unbounded NOAEC of 30 μg a.i./L is within a factor of two of the reported solubility of tolfenpyrad in water (87 μg a.i./L ).

For non

- vascular aquatic plants, RQ values range from 0.1 to 2. 8 for non

- listed species and 0.1

to 5. 6 for listed species, indicating risk to non

- vascular plants for selected crop exposure scenarios. Phytotoxic effects to algae occurred at concentrations ranging from 1 to greater than

87 μg a.i./L.

Vegetative Buffers

It should be recognized that the proposed tolfenpyrad labels contain a statement that includes

“ constructing and maintaining a minimum 15

- foot wide vegetative filter strip of grass or the permanent vegetation between field edge and down gradient aquatic habitat”. At this time, however, EFED does not have standard, approved models for evaluating the effect of vegetative buffers on aquatic EECs. Furthermore, the performance of the vegetative buffer in reducing aquatic exposure to pesticides is expected t o vary depending on the vegetation type, density, topography, soil characteristics, and maintenance of the buffer. Therefore, acute and chronic risks to aquatic organisms may be lower to the extent that the 15

- foot vegetative buffers reduce pesticide load ings to aquatic ecosystems.

5.2. 2 Risks of Tolfenpyrad to Terrestrial Organisms

Birds, Terrestrial

- phase Amphibians and Reptiles

Acute risk to birds (and by extension, terrestrial

- phase amphibians and reptiles) are indicted on

the basis of acute oral do se

- based exposures, with RQ values ranging from <0.01 to 2.5 (Table 5.4) . These RQ values are based on the most sensitive avian acute toxicity value (ED 50 

### of 58 mg a.i./kg

- bw for zebra finch based on dose

- dependent increase in regurgitation. No mortality occurred for finch which did not regurgitate the dose during this study and all fish appeared asymptomatic by the end of the study. Therefore, it seems likely that the actual LD 50 

### for finch would be higher than the ED 50 

### based on regurgitation; however how much higher is uncertain. The next highest acute toxicity value is for bobwhite quail (87 mg a.i./kg

- bw). Although there is uncertainty associated with the acute oral passerine toxicity value because it is based on a non

lethal (but ecologically relevan t) response, acute dose

- based RQ values for bobwhite quail are nearly equivalent to those based on the finch ED 50 

### , thus rendering this uncertainty of little consequence to the acute avian risk conclusions. On a dietary acute exposure basis, only one RQ

val ue meets or exceeds the avian acute risk to endangered species LOC of 0.1 (curcurbits, short grass).Page 65 of 125



### Chronic risk to birds is indicated based on a comparison of the peak EECs on terrestrial food

items and non

- definitive (“less than”) avian reproduction NOAEC of < 9.7 ppm in diet (chronic RQ range: >0.6 to >14. 4 ). These non

- definitive RQ values indicate the potential for chronic risk to avian species for all assessed uses and dietary categories except possibly fruits and pods. It is noted that the predi cted upper bound residues of tolfenpyrad on short grass, tall grass, broadleaf plants and arthropods exceed the chronic avian LOAEC of 9.7 ppm in the diet for the first 176, 137, 146 and 129 days of the T

- REX simulation for the 4 x 0.21 lb a.i./A applicati on rate for

cucurbits ( Figure 5.1 ) . Furthermore, even when mean predicted residues on terrestrial food items are considered, the predicted concentrations are approximately 1/3 those based on the upper bound residue estimates and thus, still exceed the chr onic avian LOAEL of 9.7 for all proposed uses and with most dietary categories. One possible refinement to the avian risk

estimation is the use of a chemical

- specific foliar dissipation half life instead of a default half life

of 35

- d. If the tolfenpyrad foliar half life was substantially shorter than the default value of 35 days, then the number of days residues exceed the avian LOAEL would be reduced. However, chronic risk concerns would still occur since the peak residue from a single application exceeds

the avian LOAEL.

Figure 5.1. T

- REX

- predicted upper bound concentrations of tolfenpyrad on terrestrial food items based on cucurbits (4 x 0.21 lb a.i./A @ 14

- d interval) in relation to avian acute and chronic dietary toxicity levels of concern Avian chronic LOAEL of 9.7 ppmPage 66 of 125



### Acute risks to p iscivorous birds are not indicated based on bioaccumulation modeling with KABAM in combination with measured uptake and elimination rates of tolfenpyrad in fish using the exposure scenario producing the greatest aquatic EECs. The lower bound of chronic RQ values for piscivorous birds does not exceed the chronic LOC; however, given its close proximity to the chronic LOC (within a factor of two), the potential for chronic risk cannot be discounted because a definitive NOAEC was not available from this study.

Mammals

None of the acute

- dose based RQ values derived using T

- REX exceed the acute risk to non

- listed LOC of 0.5 for mammals ( Table 5.5 ). However, the acute dose

- based RQ exceed the listed species LOC of 0.1 by up to a factor of 2.5 (small mammals consuming short grass) indicating potential acute risk to listed mammals (mostly small and medium size categories).

The potential for chron ic risks to mammals is much higher compared to acute risks, with chronic

dose

- based RQ values ranging from 0. 37 to 70.4 , depending on mammalian size class and dietary item. Chronic risk to mammals (small, medium and large) is indicated for all crop

exposu re scenarios modeled and for all dietary categories except seeds. The chronic mammalian

dose

- based RQ values are derived using a chronic mammalian NOAEL of 0.86 mg a.i./kg

bw/day for male rats

. On a chronic dietary basis, chronic risk is also indicated wi th RQ values ranging from 0.37 to 9.3

. The overall potential for chronic risks to mammals is not expected to be sensitive to the use of a default foliar half life (35

- days) or upper bound estimates of dietary residues ( Figure 5.2 ).Page 67 of 125



### Figure 5.2. T

- REX

- predicted upper bound concentrations of tolfenpyrad on terrestrial food items based on cucurbits (4 x 0.21 lb a.i./A @ 14

- d interval) in relation to mammalian acute and chronic dietary toxicity levels of concern



### For piscivorous mammals, acute risks are not indicated based on KABAM modeling ( Table 5.6 ). However, chronic risks are indicate on a dose

- basis, with RQ values ranging from 0.8 to 2.8 depending on species. The higher RQ values are indicated for species that consume a substantial portion of their aquatic diet from the lower portions of the aquatic food web (e.g., benthic invertebrates being consumed by the fog/water shrew and rice rat/star

- nose mole). Since data were not available from which to derive a tolfenpyrad metabolism rate constant for aquatic invertebrates, a default value of zero was used. This resulted in the prediction of higher residues of tolfenpyrad at the lower portion of the aquatic food webs compared to fish. If tolfenpyrad metabolism in aquatic invertebrates is similar t o that in fish, then chronic risks to these species

would be lower.

Terrestrial Plants

Risk to listed terrestrial plants is not indicated based on the maximum single application rates, as RQ values did not exceed the list and non

- listed LOC for terrestr ial plants. Because noPage 68 of 125



### inhibitory effects greater than 25% were observed in either the vegetative vigor or seedling emergence studies with tolfenpyrad 15% SC, RQs were not calculated for non

- listed species. For listed species of monocots, the NOAEC of 0.2 65 lbs a.i./acre was used to calculate RQs. For listed species of dicots, a NOAEC of 0.265 lbs a.i./acre derived from the submitted vegetative vigor study was used to calculate the potential risk from spray drift exposure only. TerrPlant v1.2.2 ( Appendix C ) and risk quotient ( RQs ) are summarized in Table 5. 7.



## 6 .0 Description of Assumptions and Limitations

6.1 Assumptions and Limitations Related to Exposure for all Taxa

Though there are a number of areas of uncertainty in the aquatic and terrestrial risk assessments

, many of the predicted environmental exposure levels do exceed the observed toxicity levels for many of the surrogate terrestrial and aquatic species tested t o date. Protective chronic levels of concern are exceeded for single as well as multiple application scenarios.

This screening

- level risk assessment relies on labeled statements of the maximum rate of tolfenpyrad application, the maximum number of appl ications, and the shortest interval between applications. Actual usage in the field may vary dependent on pest abundance.

6.2 Assumptions and Limitations Related to Exposure for Terrestrial Species

Due to very low chron ic effect levels for both avian spec ies tested, there is concern that dermal and inhalation exposure to direct spray and dietary ingestion of residues on food matter could lead to reproductive effects

. Many species have been observed to nest or raise broods in citrus and other types of frui t orchards. Young in nests are particularly susceptible in that they cannot leave the area. Adults may take flight at the sound of application equipment if there is adequate warning. See appendix I for listing of species that have been observed nesting i n orchards. Direct contact or oral ingestion for pollinators is also a major potential exposure route for crops such as almonds which are dependent on the pollination. Whether these taxa are exposed is dependent on whether infestations of target pests re quiring treatment occur in early spring months or bloom periods.

Chemical half

- life used in terrestrial exposure modeling

In the absence of actual foliar half

- life data , an assumption of 35 days was used for the terrestrial exposure modeling for avian and mammalian species. This default is based on the highest reported half

- life value (36.9 days) for foliar dissipation data for pesticides, as reported by Willis

and McDow ell (1987).

Likelihood of direct or indirect exposure

It is assumed that certain terrestrial species will be present in the treated area being modeled. Many a vian and mammalian species have been observed nesting, brood rearing and /or foraging in proposed crop areas. Others may be less directly a ffected if occupying adjacent areas receiving spray drift, but foraging activities in treated areas may follow after applications are completed.Page 69 of 125



### Differences f

eeding behavior from test scena rios The acute studies have a fixed exposure period, not allowing for the differences in response of individuals to different durations of exposure. Further, for the acute oral study, tolfenpyrad is

administered in a s ingle dose which does not mimic a wil d bird’s exposure through multiple feedings. Also, it does not account for absorption rate of the chemical into the animal. Because exposure occurs over several days, both the accumulated dose and elimination of the chemical from the body for the duration of the exposure will determine the exact exposure to wildlife.

Variation in diet composition The risk assessment and calculated RQs assume 100% of the diet is relegated to single food types foraged only from treated fields. The assumption of 100% diet from a single food type may be realistic for acute exposures, but diets are likely to be more variable over longer periods

of time . T hus, chronic exposures should assume a variety of food types for certain species.

Exposure routes other than dietary Only dietary exposure is included in the exposure assessment for risk quotient calculation. Other exposure routes are possible for animals in treated areas. These routes include ingestion of contaminated drinking water, dermal exposure (by direct or indirect m eans) and inhalation. Drinking water and inhalation exposure were assessed using two available screening tools. Because tolfenpyrad does not volatilize appreciably, inhalation does not appear to be a significant contributor to the overall exposure. The low solubility of the chemical and relatively high level of binding also suggest that runoff and puddles on the treated field are unlikely to contain the chemical at levels that may adversely impact avian or mammalian species, when drinking water exposure is considered alone. The Office of Pesticide Programs does not currently have modeling tools to assess dermal exposure to non

- target birds and mammals. Because all potential routes of exposure are not considered aggregately, the risks of a toxic response to

t olfenpyrad is underestimated in this risk assessment.

Choice of K

OW 

### Value for KABAM Modeling

A log K OW 

### of 5.61 was used as input to the KABAM model for evaluating risks to piscivorous birds and mammals from the proposed uses of tolfenpyrad. This was the h ighest of the two

available K OW 

### values. Using this value, a maximum chronic RQ of 2.8 was identified for the fog/water shrew. No acute risks were identified for birds or mammals and no chronic risks were identified for birds. If the other available log K OW 

### (4.3) was used, no acute or chronic risks would be identified to birds or mammals (maximum chronic mammalian RQ of 0.76).

6.3 Assumptions and Limitations Related to Exposure for Aquatic Species

The fate and transport database for tolfenpyrad was limited (for example, only one soil or one sediment system was used in each of the aerobic/anaerobic soil/aquatic metabolism studies), but sufficient to conduct aquatic modeling for exposure assessment of aquatic species.

1. Since only one aerobic soil or anaerobic aquatic sediment system was included and all aero b ic soil/anaerobic metabolism studies were selected from CA, the submitted studies may not represent all the proposed use areas.Page 70 of 125



### 2. Tolfenpyrad was modeled in this assessment as relativ ely persistent (half

- lives were timed with a factor of 3) because of limited number of metabolism studies are available (only one aerobic soil and one anaerobic aquatic sediment system were studied in each of the metabolism studies). If additional metabol ism studies are available, EECs could be refined and would likely

result in lower values.

3 . T olfenpyrad is a new chemical, no monitoring data were available to compare to the model

estimates.

6.4 Assumptions and Limitations Related to Effects Assessment

Toxicity of degradates to terrestrial and aquatic invertebrate/plant taxa

Acute t ests with freshwater fish show toxicity is moderate to low for the four degradates tested (LC50 values range from 768 ppb for the PT

- CA to >10,000 ppb for the PAM degradate) . These levels are well above expected EEC levels. However

, no testing results for these degradates with other taxa has been provided. Thus

, conclusions regarding toxicity of degradates to these taxa cannot be made with any certainty.

Age class and sensitivity of effects thresholds It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant. In general, testing of aquatic organisms is conducted with juvenile organisms. Testing of juvenil es may overestimate toxicity of older age classes for pesticide active ingredients

.

Use of the most sensitive species tested Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does no t necessarily mean that the selected toxicity endpoint reflect sensitivity of the most sensitive species existing in a given environment. Levels of concern have been established at lower than a ratio of 1.0 in order to add some measure of conservatism, but it is not certain whether this accounts for the most sensitive organisms. If available, t he Agency also considers toxicity data on non

- standard test species

.

Acknowledgements The authors of this document would like to thank Justin Housenger and Dr. Mic hael Barrett for

their valuable contributions to the assessment and secondary review of the initial review

.Page 71 of 125



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48953803 Brougher, D.; Kendall, T.; Krueger, H.; et al. (2012) (Inert Ingredient): A 96

- Hour Static Acute Toxicity

Test with the Rainbow Trout (Onco rhynchus mykiss): Final Report. Project Number: 397A/160, W/10036. Unpublished study prepared by Wildlife International Ltd. 39p.

48953804 Brougher, D.; Kendall, T.; Gallagher, S. et al. (2012) PT

- CA: A 96

- Hour Static Acute Toxicity Test with

the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: W/10038, 397A/162. Unpublished study prepared by Wildlife International Ltd. 40p.Page 77 of 125



### Appendix A. Summary of Minor Degradate Formation from Degradation of Tolfenpyrad

and the chemical Structures

Summary of minor degradate formation from degradation of Tolfenpyrad.

STUDY

TYPE MINOR DEGRADATE and MAXIMUM CONCENTRATION SOURCE

MRID PAM (% applied) PT

- CA (%

applied) OH

- PAM

(% applied) PCA (%

applied) PT

- OH

(% applied) PT

- CHO

(% applied) PT(A)

-

4OH (% applied) OH

- PT

OH (% applied)

Batch Equilibrium – – – – – – – –

Hydrolysis

– – – –

– – – – 47447713

Aqueous Photolysis 0.3% at 69

hours (dark pyrazole label) 4.0% at 307.5

hours (irradiated pyrazole label)

2.4% at 216

hours (irradiated tolyloxy label) – – 6.2% at 212.1

hours (irradiated pyrazole label) – – – 47463701

Soil Photolysis 0.9% at 213

-

310.3 hours (dark pyrazole label) 0.7% at 144.5

hours (irradiated pyrazole label)

2.0% at 310.3 hours (dark pyrazole label)

4.7% at 313.5 hours (dark tolyloxy label) 3.5% at 310.3

hours (irradiated pyrazole label) – 1.3% at 310.3

hours (irradiated pyrazole label)

0.2% at 213 hours (dark pyrazole label)

1.3% at 145.5

hours (irradiated tolyloxy label)

0.2% at 70.5,

145.5

- 313.5 hours (dark tolyloxy label) 6.6% at 310.3

hours (irradiated pyrazole label)

1.3% at 44.6 hours (dark pyrazole label)

2.0% at 47

hours (irradiated tolyloxy label)

0.3% at 94 hours (dark tolyloxy label) – – 47447715

Aerobic Soil

Metabolism 3.8% at 90

days (pyrazole label) – – – 0.3% at 1 day (tolyloxy label) – 4.3% at 30 days (pyrazole label) – 47447716

48250406

Anaerobic

Soil

Metabolism 4.9% at 136

days, total

system (pyrazole label) – – 4.6% at 135 days, water (tolyloxy label) – – – 0.2% at 135 days, water (tolyloxy label) 48250407

Anaerobic Aquatic

Metabolism 2.2% at 3

days, total

system (pyrazole label) – – 0.4% at 241 days, total

system (pyrazole label) – – 7.8% at 182 days, total

system (pyrazole label) – 482504.9Page 78 of 125



### Summary of minor degradate formation from degradation of Tolfenpyrad.

STUDY

TYPE MINOR DEGRADATE and MAXIMUM CONCENTRATION SOURCE

MRID
PAM (% applied) PT

- CA (%

applied) OH

- PAM

(% applied) PCA (%

applied) PT

- OH

(% applied) PT

- CHO

(% applied) PT(A)

-

4OH (% applied) OH

- PT

OH (% applied)

Aerobic Aquatic

Metabolism – – – – – – – 0.1% at 30 days, water (tolyloxy label) 48250408

- - 1.3% at 60 days – – – – - 48953811

Terrestrial

Field Dissipation – Detected only

in 0

- 15 cm soil depth – – – – – – 48250410

Studies conducted with both pyrazole and tolyloxy radiolabels include: aqueous photolysis, soil photolysis, aerobic and anaerobic soil metabolism, aerobic and anaerobic aquatic metabolism and terrestrial field dissipation. Studies conducted with pyrazole radiolabel only include hydrolysis and adsorption

- desorption. The non

- guideline analytical methods study was not radiolabelled

.Page 79 of 125



### Chemical Structures of Tolfenpyrad and its Degradates

Tolfenpyrad

IUPAC Name: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [4

- ( p

- tolyloxy)benzyl]pyrazole

- 5

- carboxamide.

CAS Name: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- N

- [[4

- (4

- methylphenoxy)phenyl]methyl]

- 1 H

pyrazole

- 5

- carboxamide.

CAS Number: 129558

- 76

- 5.

SMILES String: C3(Cl)C(CC)=NN(C)C=3C(=O)NCC1C=CC(OC2=CC=C(C)C=C2)=CC=1

( EPI Suite, v3.12 SMILES string from ISIS .MOL file). Empirical formula: C 21 

### H 22 

### ClN 3 

### O 2 

### Molecular formula: C 21 

### H 22 

### ClN 3 

### O 2



### [Pyrazole ring

- 3

- 14 

### C]Tolfenpyrad [PYR

14 

### C]Tolfenpyrad [Pyrazole

- 3

- 14 

### C]Tolfenpyrad [Pyrazole

14 

### C]Tolfenpyrad [Py

14 

### C] Tolfenpyrad

* = Location of the radiolabel.

[Tolyloxy ring

14 

### C]Tolfenpyrad [TO

14 

### C]Tolfenpyrad [To

14 

### C]TolfenpyradPage 80 of 125



### [Tolyloxy

14 

### C]Tolfenpyrad

* = Location of the radiolabel.



## PAM

IUPAC Name: 4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

- pyrazole

- 5

- carboxamide (ISIS/Draw with

ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.



## PCA [Tolfenpyrad

- PCA]

IUPAC Name : 4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

- pyrazole

- 5

- carboxylic acid (ISIS/Draw with

ACD/Name add

- in).

CAS Name : Not reported.

CAS Number : Not reported.Page 81 of 125



## PT

- CHO

IUPAC Name: 4

- Chloro

- 3

- ethyl

- N

- [4

- (4

- formylphenoxy)benzyl]

- 1

- methyl

- 1H

- pyrazole

- 5

-

carboxamide (ISIS/Draw with ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.



## PT

- OH

IUPAC Name: 4

- Chloro

- 3

- ethyl

- N

- {4

- [4

- (hydroxymethyl)phenoxy]benzyl}

- 1

- methyl

- 1H

pyrazole

- 5

- carboxamide (ISIS/Draw with ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.Page 82 of 125



## PT

- CA [Tolfenpyrad

- PT

- CA]

IUPAC Name: 4

- [4

- ({[(4

- Chloro

- 3

- ethyl

- 1

- methyl

- 1H

- pyrazol

- 5

-

yl)carbonyl]amino}methyl)phenoxy]benzoic acid (ISIS/Draw with

ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.



## PT(A)

- 4OH [PT(A)

- 4

- OH]

IUPAC Name: 4

- Chloro

- 3

- ethyl

- N

- (4

- hydroxybenzyl)

- 1

- methyl

- 1H

- pyrazole

- 5

-

carboxamide (ISIS/Draw with ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.Page 83 of 125



## OH

- PT

- OH

IUPAC Name: 4

- Chloro

- 5

- [({4

- [4

- hydroxymethyl)phenoxy ]benzyl}amino)carbonyl]

- 1

-

methyl

- 1H

- pyrazole

- 3

- carboxylic acid (ISIS/Draw with ACD/Name add

in).

CAS Name: Not reported.

CAS Number: Not reported.

OrPage 84 of 1 25



### OH

- PAM

IUPAC Name: 4

- Chloro

- 3

- (1

- hydroxyethyl)

- 1

- methyl

- 1H

- pyrazole

- 5

- carboxamide

(ISIS/Draw with ACD/Name add

- in).

CAS Name: Not reported.

CAS Number: Not reported.

### 85

Appendix B

. Proposed route of degradation of tolfenpyrad in aerobic soil system, chemical structure of tolfenpyrad and degradates and minor degradate formation

### 86



## Appendix C 

## Terrestrial Model Descriptions/ Inputs /Outputs

EFED Terrestrial Model Descriptions

The T

- REX model ( Version 1.5.1 ) calculates the residues on avian and mammalian food items to estimate acute and chronic dietary exposure and risk. As a c onservative approach, the modeled environmental exposure concentrations are the single

- day maximum.

The TerrPlant model (version 1.2.2) provides screening level estimates of exposure to terrestrial plants from single pesticide applications. TerrPlant deri ves pesticide EECs in chemical drift and runoff. The model does not consider exposures to plants from multiple pesticide applications. RQs are developed for non

- listed and listed species of monocots and dicots inhabiting dry and

semi

- aquatic areas which ar e adjacent to pesticide treatment sites.

This assessment utilizes two screening tools to assess the potential for tolfenpyrad exposure to terrestrial animals via inhalation and drinking water exposure. The potential for inhalation risk to

birds and mamma ls was assessed using the Screening Tool for Inhalation Risk (STIR, version 1.0, November 2010). The STIR tool estimates spray droplet and vapor phase exposure using the physical properties of each chemical, application method and rate and then compares th ese exposure estimates to avian and mammalian toxicity data. The model estimates avian inhalation toxicity values from available mammalian data by applying an adjustment factor representing the difference in lung tissue thickness and surface area between b irds and mammals to the relationship between mammalian

- oral, mammalian

- inhalation, and avian

- oral toxicity values to account for differences in avian and mammalian inhalation toxicity. The Screening Imbibition Program (SIP, version 1.0, July 2010) was used to provide upper

- bound drinking water exposure potential using tolfenpyrad’s solubility, the most sensitive acute and chronic avian toxicity endpoints and the most sensitive acute and chronic mammalian toxicity endpoints.

Additional information on the terrestrial exposure models and screening tools employed in this

risk assessment can be found at http://www.epa.gov/oppefed1/models/terrestrial/

.

### 87



## Example of T

- Rex Input /Output for Citrus application 0.27 Lb ai/Acre

Chemical Application Parameters:

Chemical Name: Tolfenpyrad

Use Citrus

Formulation Tolfenpyrad 15 SC

Application Rate 0.27 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



### Toxicity Endpoints

Avian zebra finch LD50 (mg/kg

- bw) 58.00

Bobwhite quail LC50 (mg/kg

- diet) 1348.00

Mallard duck NOAEL(mg/kg

- bw) 25.00

Mallard duck NOAEC (mg/kg

- diet) 9.70



### Mammals LD50 (mg/kg

- bw) 239.00
LC50 (mg/kg

- diet) 0.00 NOAEL (mg/kg

- bw) 0.86 NOAEC (mg/kg

- diet) 15.00



### TREX Outputs:

Dietary

- based EECs (ppm) Kenaga

Values

Short Grass 113.91

Tall Grass 52.21 Broadleaf plants 64.07 Fruits/pods/seeds 7.12
Arthropods 44.61

### 88

Avian Intermediate Calculations:

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 62.62

100 79.72

1000 112.60



### Avian Results:

Avian Dose

- based EECs (mg/kg

- bw) Avian Classes and Body Weights (grams)

small mid large

20 100 1000

Short Grass 129.73 73.98 33.12

Tall Grass 59.46 33.91 15.18 Broadleaf plants 72.97 41.61 18.63 Fruits/pods 8.11 4.62 2.07 Arthropods 50.81 28.97 12.97

Seeds 1.80 1.03 0.46



### Dose

- based RQs (Dose

- based EEC/adjusted LD50) Avian Acute RQs Size Class (grams)

20 100 1000

Short Grass 2.07 0.93 0.29

Tall Grass 0.95 0.43 0.13 Broadleaf plants 1.17 0.52 0.17 Fruits/pods 0.13 0.06 0.02 Arthropods 0.81 0.36 0.12

Seeds 0.03 0.01 0.00



### Dietary

- based RQs (Dietary

- based EEC/LC50 or NOAEC) RQs

Acute Chronic

Short Grass 0.08 11.74

Tall Grass 0.04 5.38 Broadleaf plants 0.05 6.61 Fruits/pods/seeds 0.01 0.73
Arthropods 0.03 4.60

### 89

Mammalian Intermediate Calculations:

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

15 525.28 1.89

Herbivores/ 35 425.01 1.53

insectivores 1000 183.83 0.66

15 525.28 1.89

Granivores 35 425.01 1.53

1000 183.83 0.66



### Mammalian Results:

Dose

- Based
EECs (mg/kg

- bw) Mammalian Classes and Body weight

(grams)

15 35 1000

Short Grass 108.60 75.06 17.40

Tall Grass 49.78 34.40 7.98 Broadleaf plants 61.09 42.22 9.79 Fruits/pods 6.79 4.69 1.09 Arthropods 42.54 29.40 6.82

Seeds 1.51 1.04 0.24



### 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

Shor t Grass 0.21 57.46 0.18 49.08 0.09 26.31

Tall Grass 0.09 26.34 0.08 22.50 0.04 12.06 Broadleaf plants 0.12 32.32 0.10 27.61 0.05 14.80 Fruits/pods 0.01 3.59 0.01 3.07 0.01 1.64

Arth ropods 0.08 22.50 0.07 19.22 0.04 10.30

Seeds 0.00 0.80 0.00 0.68 0.00 0.37

### 90

Dietary

- based RQs (Dietary

based EEC/LC50 or NOAEC) Mammal RQs

Acute Chronic

Short Grass #DIV/0! 7.59

Tall Grass #DIV/0! 3.48 Broadleaf plants #DIV/0! 4.27 Fruits/pods/seeds #DIV/0! 0.47
Arthropods #DIV/0! 2.97



## TerrPlant Output

TerrPlant v. 1.2.2

– tolfenpyrad maximum aerial and ground use scenarios

Aerial Application on Citrus

Table 1. Chemical Identity.

Chemical Name Tolfenpyrad

PC code 90111

Use Peaches Application Method Aerial
Application Form Spray Solubility in Water (ppm) 0.087

Table 2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.2 7 lb ai/A
Incorporation I 1 none
Runoff Fraction R 0.01 none

Drift Fraction D 0.05 none

Table 3. EECs for Tolfenpyrad. Units in lb ai/A.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.0027

Runoff to semi

- aquatic areas (A/I)*R*10 0.02 7 Spray drift A*D 0.014 Total for dry areas ((A/I)*R)+(A*D) 0.016 2

Total for semi

- aquatic areas ((A/I)*R*10)+(A*D) 0.04 1

Table 4. Plant survival and growth data used for RQ derivation. Units are in lb ai/A.

Seedling Emergence Vegetative Vigor
Plant type EC 25 NOAEC EC 25 NOAEC

Monocot 0.265 0.265 0.265 0.265

Dicot 0.265 0.265 0.265 0.265

### 91

Table 5. RQ values for plants in dry and semi

- aquatic areas exposed to Tolfenpyrad through runoff and/or spray drift.*

Plant Type Listed
Status Dry Semi

- Aquatic Spray Drift

Monocot non

- listed <0.1 0.16 <0.1

Monocot listed <0.1 0.16 <0.1

Dicot non

- listed <0.1 0.16 <0.1

Dicot listed <0.1 0.16 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

Ground application on Grapes

Table 1. Chemical Identity.

Chemical Name Tolfenpyrad

PC code 90111

Use Grapes
Application Method Ground Application Form Spray Solubility in Water (ppm) 0.087

Table 2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.27 lb ai/A
Incorporation I 1 none
Runoff Fraction R 0.01 none

Drift Fraction D 0.01 none

Table 3. EECs for Tolfenpyrad. Units in lb ai/A.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.0027

Runoff to semi

- aquatic areas (A/I)*R*10 0.027 Spray drift A*D 0.0027 Total for dry areas ((A/I)*R)+(A*D) 0.0054

Total for semi

- aquatic areas ((A/I)*R*10)+(A*D) 0.0297

Table 4. Plant survival and growth data used for RQ derivation. Units are in lb ai/A.

Seedling Emergence Vegetative Vigor
Plant type EC 25 NOAEC EC 25 NOAEC

Monocot 0.265 0.265 0.265 0.265

Dicot 0.265 0.265 0.265 0.265

### 92

Table 5. RQ values for plants in dry and semi

- aquatic areas exposed to Tolfenpyrad through runoff and/or spray drift.*

Plant Type Listed Status Dry Semi

- Aquatic Spray Drift

Monocot non

- listed <0.1 0.11 <0.1

Monocot listed <0.1 0.11 <0.1

Dicot non

- listed <0.1 0.11 <0.1

Dicot listed <0.1 0.11 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

### 93

Screening Tool for Inhalation Risk (STIR), version 1.0 Results:

Input

Application and Chemical Information

Enter Chemical Name Tofenpyrad

Enter Chemical Use Citrus
Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 385.7 Enter Chemical Vapor Pressure (mmHg) 3.00E

- 07 Enter Application Rate (lb a.i./acre) 0.27
Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 58
Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 239

Enter Lowest Rat Inhalation LC 50 (mg/L) 1.5
Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35

Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 6.23E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 7.83E

- 04

Adjusted Inhalation LD 50 2.03E+00

Ratio of Vapor Dose to Adjusted Inhalation

LD 50 3.86E

- 04 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.85E

- 02

Ratio of Droplet Inhalation Dose to Adjusted
Inhalation LD 50 1.41E

- 02 Exposure not Likely Significant

Results Mammalian (0.015 kg )

Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 6.23E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 9.84E

- 04

Adjusted Inhalation LD 50 8.93E+01

Ratio of Vapor Dose to Adjusted Inhalation

LD 50 1.10E

- 05 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 3.59E

- 02

Ratio of Droplet Inhalation Dose to Adjusted
Inhalation LD 50 4.02E

- 04 Exposure not Likely Significant

### 94

### 95



## Appendix D

R isk Q uotient Methods and L evel

- of

- C oncern Definitions The Risk Quotient Method is the means by which the Environmental Fate and Effects Division (EFED) integrates the results of exposure and ecotoxicity data. In this method, both acute and chronic risk quotients (RQs) are calculated by dividing exposure estimates by the most s ensitive ecotoxicity values derived from the studies. Calculated RQs are then compared to levels

- of

concern (LOCs). The LOCs are the criteria used by Office of Pesticide Programs to indicate potential risk to non

- target organisms and the need to consider r egulatory action. EFED has defined LOCs for acute risk, potential restricted use, and for listed species. Risk presumptions, along with the corresponding RQs and LOCs are summarized in the table below.

Table D

- 1. Levels of Concern for Assessed Taxa

Risk Presumption RQ LOC

Birds

Acute Risk EEC/LC 50 or LD 50 /sqft or LD 50 /day 0.5

Acute Restricted Use EEC/LC 50 or LD 50 /sqft or LD 50 /day (or LD 50 < 50 mg/kg) 0.2

Acute Listed Species EEC/LC 50 or LD 50 /sqft or LD 50 /day 0.1

Chronic Risk EEC/NOAEC 1

Mammals

Acute Risk EEC/LC 50 or LD 50 /sqft or LD 50 /day 0.5

Acute Restricted Use EEC/LC 50 or LD 50 /sqft or LD 50 /day (or LD 50 < 50 mg/kg) 0.2

Acute Listed Species EEC/LC 50 or LD 50 /sqft or LD 50 /day 0.1

Chronic Risk EEC/NOAEC 1

Aquatic Animals

Acute Risk EEC/LC 50 or EC 50 0.5

Acute Restricted Use EEC/LC 50 or EC 50 0.1

Acute Listed Species EEC/LC 50 or EC 50 0.05

Chronic Risk EEC/NOAEC 1

Terrestrial and Semi

- Aquatic Plants

Acute Risk EEC/EC 25 1

Acute Listed Species EEC/EC 05 or NOAEC 1

Aquatic Plants

Acute Risk EEC/EC 50 1

Acute Listed Species EEC/EC 05 or NOAEC 1

### 96 A ppendix E

. KABAM Inputs and Outputs for TX Cotton Scenario

The KABAM model (K OW 

### (based) Aquatic BioAccumulation Model) version 1.0 was used as the primary tool for evaluating the potential expos ure and risk to birds and mammals that feed on aquatic organisms . KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aquatic organisms which have bioaccumulated these pesticides. The bioaccumulation portion of KABAM is based upon work by Arnot and Gobas (2004) who parameterized a bioacc umulation

model based on PCBs and some pesticides, such as lindane and DDT, in freshwater aquatic ecosystems. KABAM relies on a chemical's octanol

- water partition coefficient (K OW 

### ) to estimate uptake and elimination constants through respiration and diet o f organisms in different trophic levels. Pesticide tissue residues are calculated for organisms at different trophic levels of an aquatic food web. Although the default parameterization of KABAM assumes no chemical metabolism by biota, the metabolism rate constant can be adjusted to reflect appropriate information on chemical metabolism. The model then uses pesticide tissue concentrations in aquatic animals to estimate dose

- and dietary

- based exposures and associated risks to mammals

and bird s consuming aq uatic organisms. The KABAM model and associated documentation can

be found at http://www.epa.gov/oppefed1/models/water/kabam/kabam_user_guide_appendix_d.html

.

Table E

- 1. Chemical characteristics of Tolfenpyrad.

Characteristic Value Comments/Guidance

Pesticide Name Tolfenpyrad Required input

Log K OW 5.61 Required input Enter value from acceptable or supplemental study submitted by registrant or available in scientific literature.

K OW 407380 No input necessary. This value is calculated automatically from the Log K OW value entered above.

K OC (L/kg OC) 29380 Required input Input value used in PRZM/EXAMS to derive EECs. Follow input parameter guidance for deriving this parameter value (USEPA 2002). Time to steady state (T S ; days) 113 No input necessary. This value is calculated automatically from the Log K OW value entered above.

Pore water EEC (μg/L) 0.31 Required input Enter value generated by PRZM/EXAMS benthic file. PRZM/EXAMS EEC represents the freely dissolved concentration of the pesticide in the pore water of the sediment. The appropriate averaging period of the EEC is dependent on the specific pesticide being mod eled and is based on the time it takes for the chemical to reach steady state. Select the EEC generated by PRZM/EXAMS which has an averaging period closest to the time to steady state calculated above. In cases where the time to steady state

exceeds 365 d ays, the user should select the EEC representing the average of yearly averages. The peak EEC

should not be used.

Water Column EEC (μg/L) 2.68 Required input Enter value generated by PRZM/EXAMS water column file. PRZM/EXAMS EEC represents the freely dissolved

### 97

Table E

- 1. Chemical characteristics of Tolfenpyrad.

Characteristic Value Comments/Guidance concentration of the pesticide in the water column. The appropriate averaging period of the EEC is dependent on the specific pesticide being modeled and is based on the time it takes for the chemical to reach steady state. The averaging period used for the water column EEC should be the same as the one selected for the pore water EEC (discussed above).

Table E

- 2. Input parameters fo r rate constants. "calculated" indicates that model will calculate

rate constant.

Trophic level k 1 (L/kg*d) k 2

(d - 1 ) k D

(kg

- food/kg

org/d) k E

(d - 1 ) k M *

(d - 1 ) phytoplankton calculated calculated 0* 0* 0 zooplankton calculated calculated calculated calculated 0

benthic invertebrates calculated calculated calculated calculated 0

filter feeders calculated calculated calculated calculated 0

small fish 651.5 0.214 calculated 0 0

medium fish 651.5 0.214 calculated 0 0 large fish 651.5 0.214 calculated 0 0

* Default value is 0.

k 1 and k 2 represent the uptake and elimination constants respectively, through respiration.

k D and k E represent the uptake and elimination constants, respectively, through diet.

k M represents the metabolism rate constant.

Table E

- 3. Mammalian and avian toxicity data for Tolfenpyrad. These are required inputs.

Animal Measure of effect (units) Value Species If selected species is "other," enter body weight (in kg) here.

Avian LD 50 (mg/kg

- bw) 58 other 0.012

LC 50 (mg/kg

- diet) 1348 Northern bobwhite quail NOAEC (mg/kg

diet) 9.7 mallard duck

Mineau Scaling

Factor 1.15 Default value for all species is 1.15 (for chemical specific values, see Mineau et al.

1996).

Mammalian LD 50 (mg/kg

- bw) 239 laboratory rat

LC 50 (mg/kg

- diet) N/A laboratory rat Chronic Endpoint 0.86 laboratory rat

units of chronic endpoint* mg/kg

- bw

*ppm = mg/kg

- diet

### 98

Table E

- 4. Abiotic characteristics of the model aquatic ecosystem.

Characteristic Value Guidance*

Concentration of Particulate Organic
Carbon (X POC ; kg OC/ L) 0.00E+00

When using EECs generated by PRZM/EXAMS, use a value of “0” for
both POC and DOC. Concentration of Dissolved Organic
Carbon (X DOC ; kg OC/L) 0.00E+00

Concentration of

Dissolved Oxygen (C OX ; mg O 2 /L) 5.0 Default value is 5.0 mg O 2 /L when using EECs generated by
PRZM/EXAMS.

Water Temperature (T; o C) 15 Value is defined by the average water temperature of the EXAMS pond when using EECs generated by PRZM/EXAMS. Model user should consult output file of EXAMS to define this value.

Concentration of Suspended Solids (C SS ; kg/L) 3.00E

- 05 Default value is 3.00x10 - 5 kg/L when using EECs generated by
PRZM/EXAMS.

Sediment Organic
Carbon (OC; %) 4.0% Default value is 4.0% when using EECs generated by PRZM/EXAMS.

*When using pesticide concentrations from monitoring data or mesocosm studies, consult Appendix B of the User’s Guide for specific guidance on selecting values for these parameters.

Table E

- 5. Characteristics of aquatic biota of the model ecosystem.

Trophic Level Wet Weight (kg) % lipids % NLOM % Water Do organisms in trophic level respire some pore water?

sediment* N/A 0.0% 4.0% 96.0% N/A phytoplankton N/A 2.0% 8.0% 90.0% no zooplankton 1.0E

- 07 3.0% 12.0% 85.0% no
benthic invertebrates 1.0E

- 04 3.0% 21.0% 76.0% yes filter feeders 1.0E

- 03 2.0% 13.0% 85.0% yes small fish 1.0E

- 02 4.0% 23.0% 73.0% yes medium fish 1.0E

- 01 4.0% 23.0% 73.0% yes large fish 1.0E+00 4.0% 23.0% 73.0% no *Note that sediment is not a trophic level. It is included in this table because it is consumed by aquatic organisms of the KABAM foodweb. N/A = not applicable

Table E

- 6. Diets of aquatic biota of the model ecosystem.

Diet for: Trophic level in

diet Zoo plankton Benthic

Invertebrates Filter

Feeder Small Fish Medium

Fish Large Fish

sediment* 0.0% 34.0% 34.0% 0.0% 0.0% 0.0% phytoplankton 100.0% 33.0% 33.0% 0.0% 0.0% 0.0% zooplankton 33.0% 33.0% 50.0% 0.0% 0.0%

benthic invertebrates 0.0% 50.0% 50.0% 0.0%

### 99

Table E

- 6. Diets of aquatic biota of the model ecosystem.

Diet for: Trophic level in

diet Zoo plankton Benthic

Invertebrates Filter

Feeder Small Fish Medium

Fish Large Fish

filter feeders 0.0% 0.0% 0.0%

small fish 50.0% 0.0%

medium fish 100.0%

Total 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
*Note that sediment is not a trophic level. It is included in this table because it is consumed by aquatic organisms of the KABAM foodweb.

Table E

- 7. Identification of mammals and birds feeding on aquatic biota of the model ecosystem.

Mammal/Bird # Name Body weight (kg)

Mammal 1 fog/water shrew 0.018

Mammal 2 rice rat/star

- nosed mole 0.085

Mammal 3 small mink 0.45

Mammal 4 large mink 1.8

Mammal 5 small river otter 5

Mammal 6 large river otter 15

Bird 1 sandpipers 0.02

Bird 2 cranes 6.7

Bird 3 rails 0.07

Bird 4 herons 2.9

Bird 5 small osprey 1.25

Bird 6 white pelican 7.5

Table E

- 8. Diets of mammals feeding on aquatic biota of the model ecosystem.

Trophic level in

diet Diet for:

fog/water

shrew rice

rat/star

nosed

mole small

mink large

mink small

river otter large river

otter phytoplankton 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% zooplankton 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

benthic

invertebrates 100.0% 34.0% 0.0% 0.0% 0.0% 0.0%

filter feeders 0.0% 33.0% 0.0% 0.0% 0.0% 0.0%

small fish 0.0% 33.0% 0.0% 0.0% 0.0% 0.0%

medium fish 0.0% 0.0% 100.0% 100.0% 100.0% 0.0% large fish 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%

Total 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%

### 100

Table E

- 9. Diets of birds feeding on aquatic biota of the model ecosystem.

Diet for: Trophic level in

diet sandpipers cranes rails herons small

osprey white

pelican phytoplankton 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% zooplankton 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

benthic

invertebrates 33.0% 33.0% 50.0% 50.0% 0.0% 0.0%

filter feeders 33.0% 33.0% 0.0% 0.0% 0.0% 0.0%

small fish 34.0% 0.0% 50.0% 0.0% 0.0% 0.0%

medium fish 0.0% 34.0% 0.0% 50.0% 100.0% 0.0% large fish 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%

Total 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%

Table E

- 1 0 . Estimated concentrations of Tolfenpyrad (TX Cotton) in ecosystem components.

Ecosystem Component Total
concentration (μg/kg

- ww) Lipid

normalized

concentration (μg/kg

- lipid) Contribution

due to diet (μg/kg

- ww) Contribution

due to respiration (μg/kg

- ww) Water (total)* 0.47 N/A N/A N/A Water (freely dissolved)* 0.47 N/A N/A N/A Sediment (pore water)* 0.31 N/A N/A N/A Sediment (in solid)** 364 N/A N/A N/A Phytoplankton 8,036 401795 N/A 8,035.90 Zooplankton 7,146 238190 735.24 6,410.46

Benthic Invertebrates 8,559 285299 1,958.67 6,600.29

Filter Feeders 5,610 280498 1,263.39 4,346.58
Small Fish 3,254 81354 1,855.85 1,398.30

Medium Fish 2,392 59793 990.41 1,401.32 Large Fish 1,712 42796 284.30 1,427.53 * Units: μg/L; **Units: μg/kg

- dw

Table E

- 1 1 . Total BCFand BAF values of Tolfenpyrad (TX Cotton) in aquatic trophic levels.

Trophic Level Total BCF (μg/kg

ww)/(μg/L) Total BAF

(μg/kg

ww)/(μg/L) Phytoplankton 19555 17098 Zooplankton 13933 15204

Benthic Invertebrates 14957 18211

Filter Feeders 9832 11936
Small Fish 2993 6924

Medium Fish 2993 5089 Large Fish 3044 3642

### 101

Table E

- 12. Lipid

- normalized BCF, BAF, BMF and BSAF values of Tolfenpyrad (TX Cotton) in aquatic trophic levels.

Trophic Level BCF (μg/kg

lipid)/(μg/L) BAF

(μg/kg

lipid)/(μg/L) BMF

(μg/kg

lipid)/(μg/kg

lipid) BSAF

(μg/kg

lipid)/(μg/kg

OC) Phytoplankton 977758 854883 N/A 44 Zooplankton 464442 506787 0.59 26

Benthic Invertebrates 498580 607018 1.35 31

Filter Feeders 491589 596805 1.33 31
Small Fish 74814 173093 0.31 9

Medium Fish 74814 127220 0.33 7 Large Fish 76110 91055 0.72 5

Table E

- 1 3 . Calculation of EECs for mammals and birds consuming fish contaminated by Tolfenpyrad (TX Cotton).
Wildlife Species Biological Parameters EECs (pesticide intake) Body Weight (kg) Dry Food

Ingestion Rate (kg

dry food/kg

bw /day) Wet Food

Ingestion Rate (kg

wet food/kg

bw/day) Drinking

Water

Intake (L/d) Dose

Based (mg/kg

bw/d) Dietary

Based (ppm)

Mammalian fog/water shrew 0.02 0.140 0.585 0.003 5.009 8.56
rice rat/star

nosed mole 0.1 0.107 0.484 0.011 2.823 5.84

small mink 0.5 0.079 0.293 0.048 0.702 2.39 large mink 1.8 0.062 0.229 0.168 0.548 2.39

small river otter 5.0 0.052 0.191 0.421 0.457 2.39 large river otter 15.0 0.042 0.157 1.133 0.269 1.71

Avian sandpipers 0.0 0.228 1.034 0.004 5.9779 5.78

cranes 6.7 0.030 0.136 0.211 0.7460 5.49

rails 0.1 0.147 0.577 0.010 3.4103 5.91

herons 2.9 0.040 0.157 0.120 0.8618 5.48 small osprey 1.3 0.054 0.199 0.069 0.4769 2.39 white pelican 7.5 0.029 0.107 0.228 0.1827 1.71

Table E

- 14 . Calculation of toxicity values for mammals and birds consuming fish contaminated by Tolfenpyrad (TX Cotton).

Wildlife Species Toxicity Values

Acute Chronic

Dose

Based (mg/kg

bw) Dietary

Based (mg/kg

- diet) Dose Based

(mg/kg

- bw) Dietary

Based (mg/kg

diet)

Mammalian fog/water shrew 501.9 N/A 1.81 17.2
rice rat/star

nosed mole 340.5 N/A 1.23 17.2

### 102

Table E

- 14 . Calculation of toxicity values for mammals and birds consuming fish contaminated by Tolfenpyrad (TX Cotton).

Wildlife Species Toxicity Values

Acute Chronic

Dose

Based (mg/kg

bw) Dietary

Based (mg/kg

- diet) Dose Based

(mg/kg

- bw) Dietary

Based (mg/kg

diet)

small mink 224.4 N/A 0.81 17.2 large mink 158.7 N/A 0.57 17.2

small river otter 122.9 N/A 0.44 17.2 large river otter 93.4 N/A 0.34 17.2

Avian sandpipers 62.7 1348.00 N/A 9.7

cranes 149.9 1348.00 N/A 9.7

rails 75.6 1348.00 N/A 9.7

herons 132.2 1348.00 N/A 9.7 small osprey 116.5 1348.00 N/A 9.7 white pelican 152.5 1348.00 N/A 9.7

Table E

- 15 . Calculation of RQ values for mammals and birds consuming fish contaminated by Tolfenpyrad (TX Cotton).

Wildlife Species Acute Chronic

Dose

Based Dietary

Based Dose Based Dietary

Based

Mammalian fog/water shrew 0.010 N/A 2.77 0.50
rice rat/star

nosed mole 0.008 N/A 2.30 0.34

small mink 0.003 N/A 0.87 0.14 large mink 0.003 N/A 0.96 0.14

small river otter 0.004 N/A 1.03 0.14 large river otter 0.003 N/A 0.80 0.10

Avian sandpipers 0.095 0.004 N/A 0.60

cranes 0.005 0.004 N/A 0.57

rails 0.045 0.004 N/A 0.61

herons 0.007 0.004 N/A 0.56 small osprey 0.004 0.002 N/A 0.25 white pelican 0.001 0.001 N/A 0.18

### 103



## Appendix F

Health Effects Division mammalian toxicity profile

Table F

- 1 Acute Toxicity Profile

- Tolfenpyrad

Guideline

No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute Oral

- Rat 47457501 LD 50 Males => 386 mg/kg bw

LD 50 Females =>150 mg/kg bw

LD 50 Combined =>239 mg/kg bw II

870.1200 Acute Dermal

- Rat 47457503 LD 50 Males > 2000 mg/kg bw

LD 50 Females > 3000 mg/kg bw

LD 50 Combined > 2500 mg/kg bw III

870.1300 Acute Inhalation

Rat 47447734 LC 50 Males >2.21 mg/L

LC 50 Females >1.50 mg/L

LC 50 Combined >1.82 mg/L III

870.2400 Acute Eye

Irritation

- Rabbit 47457505 Mildly irritating III

870.2500 Acute Dermal

Irritation

- Rabbit 47457507 Slightly irritating IV

870.2600 Skin

Sensitization

Guinea Pig 47447740 Not Sensitizing

-

Table F

- 2 Subchronic, Chronic and Other Toxicity Profile for Tolfenpyrad Type of Study/Gui

de line Study Title MRID Results

870.3100 90

- Day Oral

Toxicity, Rat w/4 week recovery 47447743 Levels tested: 0, 15, 80, 160 ppm or 0/0, 0.9/1, 4.8/5.2, 9.3/9.3 mg/kg/day in males/females

NOAEL (M/F) =15 ppm or 0.9/1 mg/kg/day LOAEL (M/F) = 80 ppm or 4.8/5.2 mg/kg/day, based on decreased body weight (5

- 9%), body weight gain (8

- 13%), and

food con sumption in both sexes; increased relative liver and kidney weight, hepatocellular hypertrophy and kidney hypertrophy, hyaline droplets in the kidney, brown color change in the liver.; brown color change in the harderian gland along with hypersecretion.

Additionally at 160 ppm, decreased body weight (8

- 26%), body weight gain (35

- 41%) and food consumption; small sex organs (seminal vesicle, ovary, uterus, and vagina; ovarian and uterine atrophy and decreased ovarian weight.

870.3100 90

- Day Oral

Toxicity, Mouse 47463702

and

47447801 Levels tested: 0, 15, 100, 300 pm or 0/0, 2.4/3.0, 15.9/20.2,

46.2/57.9 mg/kg/day in males/females NOAEL (M/F)

- 300 ppm or 46.2/57.9 mg/kg/day LOAEL (M/F)

- not determined in main study; 600 ppm (104/126

### 104

Table F

- 2 Subchronic, Chronic and Other Toxicity Profile for Tolfenpyrad Type of Study/Gui

de line Study Title MRID Results

mg/kg/day) based on dec reased body weights, body weight gains, clinical signs (rough coats, hunched posture, ataxia, hypoactivity), and moribundity/mortality seen in 28 day oral study.

Note: Decreased Body weight gain (42%) was observed at 300 ppm in the range

- finding study; how ever, 600 ppm (the HDT) was selected as the LOAEL for the 90 day mouse study since no effects on body weight gain were seen in this study at 300 ppm.

870.3150 4

- week Oral

Toxicity, Dog (capsule)

13

- week Oral Toxicity, Dog (capsule) 47447805

47447803 Levels tested: 0, 1, 5, 10 mg/kg/day

NOAEL (M/F) = 5 mg/kg/day LOAEL (M/F) = 10 mg/kg/day, based on abnormal feces and liver and kidney histopathology.

Levels tested: 0, 1, 5, 10 mg/kg/day NOAEL (M/F) = 10 mg/kg/day LOAEL (M/F) = Not determined

870.3150 13

- week Oral

Toxicity, Dog (capsule) 47447804 Levels tested: 0, 10, 30, 100 mg/kg/day NOAEL (M/F) = 10 mg/kg/day LOAEL (M/F) = 30 mg/kg/day, based on mortality (1/4 males); clinical signs (no defecation/watery feces, emaciation, decrease in spontaneous movement, and staggering gait); decreased body weights, body weight gains, and food consumption; and effects on the liver (increased cytoplasmic eosinophilia and centrilobular vacuolation in the hepatocytes) and in males, testes (atrophy) and kidney (vacuolization of tubular epithelium).

870.3200 21

- Day Dermal 47447806 Levels tested: 0, 10, 50, 200 mg/kg/day NOAEL (M/F) = 200 mg/kg/day LOAEL (M/F ) = not determined

At ≥ 50 mg/kg/day, decreased body weight gain and food consumption observed.

870.3250 90

- Day Dermal No study Available: Waiver request submitted

870.3465 4

- Week Inhalation

Toxicity, Rat 47447728

and

48250484 (range

finding) Levels tested: 0, 0.50, 2.0, 10 mg/m 3 or 0, 0.0005, 0.002, and 0.01

mg/L NOAEL = 10 mg/m 3 (EPA calculated 2.6 mg/kg/day)

LOAEL = not determined Mortality observed at 26 mg/m 3 (EPA calculated 6.8 mg/kg/day) in range

- finding study. No mortality seen at the next lowest dose

of 10.9 mg/m 3

870.3700a Developmental

Toxicity, Rat (Gavage) 47447809 Levels tested: 0, 1, 3, 4.5 mg/kg/day; GD 6

- 15) Maternal NOAEL =1mg/kg/day Maternal LOAEL = 3 mg/kg/day, based on decreased body weight gains and food consumption Developmental NOAEL = 3 mg/kg/day Developmental LOAEL = 4.5 mg/kg/day, based on increased

incidences of 14 th ribs, decreased fetal body weights, and decreased number of ossified metacarpals.

870.3700b Deve lopmental

Toxicity, Rabbit (Gavage) 47447811 Levels tested: 0, 1, 3, 6 mg/kg/day GD 6

- 18 Maternal NOAEL = 6 mg/kg/day Maternal LOAEL = 9 mg/kg/day. The maternal LOAEL was not established in the current study but was 9 mg/kg/day in the

### 105

Table F

- 2 Subchronic, Chronic and Other Toxicity Profile for Tolfenpyrad Type of Study/Gui

de line Study Title MRID Results

preliminary study (M RID 47447810) based on a single mortality, emaciation, and on decreased body weights, body weight gains, and food consumption Developmental NOAEL = 6 mg/kg/day Developmental LOAEL = 9 mg/kg/day. The developmental LOAEL was not established in the current study but was 9 mg/kg/day in the preliminary study based on increased early resorption and incidences of supernumerary coronary orifices,

fusion of the ossification centers of the caudal vertebral bodies,

13 th ribs, and delayed ossification of the manus

870.3800 2 Generation

Reproduction, Rat (feeding) 47447817 Levels tested: 0, 0.75, 1.5, or 3.0 mg/kg/day.

Parental NOAEL 1.5 mg/kg/day

Parental LOAEL = 3.0 mg/kg/day , based on decreased body weight and body weight gains

, decreased motor activity, reddish tears, and prone position prior to death in two dams. Reproductive NOAEL 1.5 mg/kg/day Reproductive LOAEL= 3.0 mg/kg/day

, based on decreased gestation index, increased gestation duration, a bnormal parturition, and total litter loss Offspring NOAEL = 1.5 mg/kg/day Offspring LOAEL = 3.0 mg/kg/day

, based on decreased pup viability and body weights, and delays in attainment of developmental landmarks (eye opening, pinna folding, surface rightin g reflex)

870.3800 1 Generation

Reproduction, Rat (feeding) 47447816 Levels tested: 0, 15, 50, 100 ppm or 0/0, 0.86/0.92, 2.7/2.9, 4.8/4.4 mg/kg/day.

Parental NOAEL 15 ppm or 0.86/0.92 mg/kg/day

Parental LOAEL = 50 ppm or 2.7/2.9 mg/kg/day

, based on decreased body weight gains and food consumption during pre

mating, and on decreased body weights during gestation and

lactation in the females. Reproductive NOAEL 50 ppm Reproductive LOAEL= 100 ppm or 4.8/4.4, based on increased gestation durat ion Offspring NOAEL = 15 ppm Offspring LOAEL = 50 ppm, based on decreased body weights and body weight gains in both sexes.

870.4100 Chronic Toxicity

- 1

Year, Dog (feeding) 47442818 Levels tested: 0, 1, 5, 10 (reduced from 20) mg/kg/day NOAEL (M/F) 5 mg/ kg/day LOAEL (M/F) 10 mg/kg/day, based on mortality, vomiting, decreased body weights, body weight gains, food consumption,, increased serum alanine aminotransferase in the males, and microscopic liver findings in males and females

870.4200b Chronic/ Oncogenic

ity, 2

- Year, Rat (feeding) 47463704 Levels tested: 0, 15, 40, 80 ppm or 0/0, 0.6/0.7, 1.5/1.9, and 3.1/3.8 mg/kg/day in males/females NOAEL (M/F) 15 ppm or 0.6/0.7 mg/kg/day LOAEL (M/F) 40 ppm or 1.5/1.9 mg/kg/day , based on decreased body weigh t, body weight gain, and food consumption of females, gross changes in the Harderian glands of males, and histopathological changes in the liver, kidney and mesenteric lymph nodes of females and the kidney of males

.

### 106

Table F

- 2 Subchronic, Chronic and Other Toxicity Profile for Tolfenpyrad Type of Study/Gui

de line Study Title MRID Results

870.6200a Acute

Neurotoxicity, Rat ( gavage) 47447831 Levels tested: 0, 20, 40, 60 mg/kg/day in males and 0, 10, 20, or 40 mg/kg/day in females. NOAEL (M/ F) = 1 0 mg/kg/day LOAEL (M/F) = 2 0 mg/kg/day, based on decreases in body weight, body weight gain and food consumption in females.

870.6200b Subchronic

Neurotoxicity, Rat (feeding 47447830 0, 15, 40, 80 ppm or 0/0, 1/1.2, 2.7/3.2, 5.4/6 mg/kg/day NOAEL (M/F) =40 ppm or 2.7/3.2 mg/kg/day LOAEL (M/F) = 80 ppm or 5.4/6 mg/kg/day, based on decreased body weights, body weight gains, and f ood consumption

870.6300 Developmental

Neurotoxicity, Rat No study Available: Waiver request submitted

870.7485 Metabolism, Rat 47447837, 47447836, 47447834, 47447833, and

47447835 The test compound was rapidly absorbed and

excreted. Total recoveries ranged from 91.3

- 99.6% of the administered dose (AD) across all groups and in both sexes. Feces were the predominant route of excretion. Across all single dose groups, 88.2

- 93.2% AD was excreted in the feces and 1.7

- 3.0%

AD was eliminated in t he urine. Negligible amounts of radioactivity were recovered in the expired air and cage wash, both accounting for
≤0.1% AD. In the bile duct

- cannulated rats at 48 h

post

- dosing, the majority of radioactivity was excreted in the bile (51.3

- 69.5% AD), wit h minor amounts eliminated in the feces (3.5

- 8.3% AD) and urine (0.7

- 3.0% AD), indicating that bile was the primary route of excretion for the absorbed test material. Absorption (defined as radioactivity found in the bile, urine, cage wash, and carcass) w as greater in males (72.8

- 77.8% AD) than in females (57.9

- 69.4% AD). Females also had more radioactivity remaining in the gastrointestinal tract, and the amount remaining increased with dose.

870.7600 Dermal

Penetration, Rat 47447839 At 24 hours in the 1 g/L group, the dermal absorption is 13%.

Non guideline

New data Comparative in

vitro dermal absorption study using human and

rat skin 48233401 At 24 hrs, the total absorbed dose (absorbed + absorbable dose) at the high dose was 1.12% in

human skin and 26.78% in rats skin. At the low dose, the total absorbed dose was 6.49% in human

skin and 67.02% in rat skin.

870.7800 Developmental

Immunotoxic ity, Rat (feeding) 47447840 Levels tested: 0, 0.75, 3 mg/kg/day Maternal NOAEL = 0.75 mg/kg/day Maternal LOAEL = 3 mg/kg/day, based on decreased body weight (up to 10%) , body weight gain (up to 36%) , and food consumption in the P generation

Offspring NOAEL = 0.75 mg/kg/day Offspring LOAEL = 3 mg/kg/day, based on decreased survival, body weight, and body weight gains; increased incidence of blackish abdominal cavity and dark green abnormal intestinal content;

### 107

Table F

- 2 Subchronic, Chronic and Other Toxicity Profile for Tolfenpyrad Type of Study/Gui

de line Study Title MRID Results

and decreased thymus and spleen weights in t he F1 and/or F2 generations

Note: No treatment

- related effects noted on the immune system.

### 108

Appendix G . ECOSAR Output for Tolfenpyrad and Metabolites

1. ECOSAR Results for TOLFENPYRAD using ESTIMATED Log Kow of 6.45

SMILES : N(Cc3ccc(Oc2ccc(C)cc2)cc3)C(=O)c1c(CL)c(CC)nn1C CHEM : tolfenpyrad

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C21 H22 CL1 N3 O2

MOL WT : 383.88 Log Kow: 6.45 (KowWin estimate)

Melt Pt: Wat Sol: 0.01186 mg/L (WskowWin estimate)

ECOSAR v1.00 Cl ass(es) Found

------------------------------ Amides Pyrazoles/Pyrroles

Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

========================== = ================== ======== Amides : Fish 96

- hr LC50 0.015 * Amides : Daphnid 48

- hr LC50 0.039 * Amides : Green Algae 96

- hr EC 50 0.048 *

Amides : Fish ChV 8.77e

- 005 Amides : Daphnid ChV 0.000513 !

Amides : Green Algae ChV 0.641 *

Pyra zoles/Pyrroles : Fish 96

- hr LC50 0.009 Pyrazoles/Pyrroles : Daphnid 48

- hr LC50 0.088 * Pyrazoles/Pyrroles : Fish ChV 0.00134 ! Pyrazoles/Pyrroles : Daphnid ChV 0.004 !

=========================== ================== ======== ====== ========== Neutral Organic SAR : Fish 96

- hr LC50 0.050 * (Baseline Toxicity) : Daphnid 48

- hr LC50 0.050 *

: Green Algae 96

- hr EC50 0.133 *

: Fish ChV 0.004 : Daphnid ChV 0.010 : Green Algae ChV 0.109 *

### 109

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted effect.

Note: ! = exclamation designates: The toxic ity value was determined from a predicted SAR using established acute

- to

- chronic ratios and ECOSAR regression techniques which are documented in the supporting Technical Reference Manual. When possible, this toxicity value should be

con sidered in a weight of evidence approach.

Amides :

------- No limitations known at this time.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: >8.5 (LC50) Maximum LogKow: >8.0 (EC50,ChV)

Maximum Mol Wt: 1000

Pyrazoles/ Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemical is greater than 5.0, or if the compound is solid and the LC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4, or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------- ------------------ Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKo w: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

### 110 2. ECOSAR Results for TOLFENPYRAD using MEASURED Log Kow of 4.3

SMILES : N(Cc3ccc(Oc2ccc(C)cc2)cc3)C(=O)c1c(CL)c(CC)nn1C CHEM : tolfenpyrad

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C21 H22 CL1 N3 O2

MOL WT : 383.88 Log Kow: 4.30 (User entered)

Melt Pt: Wat Sol: 0.8191 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------ Amides Pyrazoles/Pyrroles

Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ======== Amides : Fish 96

- hr LC50 0.750 Amides : Daphnid 48

- hr LC50 0.935 * Amides : Green Algae 96

- hr EC50 0.193

Amides : Fish ChV 0.004 Amides : Daphnid ChV 0.012 ! Amides : Green Algae ChV 0.641

Pyrazoles/Pyrroles : Fish 96

- hr LC50 0.140 Pyrazoles/Pyrroles : Daphnid 48

- hr LC50 0.578 Pyrazoles/Pyrroles : Fish ChV 0.018 ! Pyrazoles/Pyrroles : Daphnid ChV 0.033 !

=========================== ================== ======== Neutral Organic SAR : Fish 96

- hr LC50 3.347 * (Baseline Toxicity) : Daphnid 48

- hr LC50 2.550 *

: Green Algae 96

- hr EC50 2.825 *

: Fish ChV 0.302 : Daphnid ChV 0.354 : Green Algae ChV 1.556 *

### 111

Note: * = asterisk desig nates: Chemical may not be soluble enough to measure this predicted effect.

Note: ! = exclamation designates: The toxicity value was determined from a predicted SAR using established acute

- to

- chronic ratios and ECOSAR regression techn iques which are documented in the supporting Technical Reference Manual. When possible, this toxicity value should be considered in a weight of evidence approach.

Amides :

------- No limitations known at this time.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: >8.5 (LC50) Maximum LogKow: >8.0 (EC50,ChV)

Maximum Mol Wt: 1000

Pyrazoles/Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemical is greater th an 5.0, or if the compound is solid and the LC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4, or if the compo und is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exce eds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

### 112 3. ECOSAR Results for PT

- CA using ESTIMATED Log Kow of 5.79 SMILES : N(Cc3ccc(Oc2ccc(cc2)C(=O)(O))cc3)C(=O)c1c(CL)c(CC)nn1C

CHEM : PT

- CA

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C21 H20 CL1 N3 O4

MOL WT : 413.86 Log Kow: 5.79 (KowWin estimate)

Melt Pt: Wat Sol: 0.02864 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------ Amides

- acid Pyrazoles/Pyrroles

- acid

Predicted

ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ========

-- > Acid moeity found: Predicted values multiplied by 10

Amides

- acid : Fish 96

- hr LC50 0.538 *

Amides

- acid : Daphnid 48

- hr LC50 1.121 *

Amides

- acid : Green Algae 96

- hr EC50 0.801 *

Amides

- acid : Fish ChV 0.003

Amides

- acid : Daphnid ChV 0.015 !

Amides

- acid : Green Algae ChV 6.914 *

Pyrazoles/Pyrroles

- acid : Fish 96

- hr LC50 0.226 * Pyrazoles/Pyrroles

- acid : Daphnid 48

- hr LC50 1.698 * Pyrazoles/Pyrroles

- ac id : Fish ChV 0.033 *! Pyrazoles/Pyr roles

- acid : Daphnid ChV 0.078 *!

=========================== ================== ======== Neutral Organi c SAR : Fish 96

- hr LC50 0.199 * (Baseline Toxicity) : Daphnid 48

- hr LC50 0.181 *

: Green Algae 96

- hr EC50 0.370 *

: F ish ChV 0.017 : Daphnid ChV 0.033 * : Green Algae ChV 0.267 *

Note: * = asterisk designates: Chemical may not be soluble

### 113

enough to measure this predicted effect.

Note: ! = exclamation designates: The toxicity value was determined from a predicted SAR using established acute

- to

- chronic ratios and EC OSAR regression techniques which are documented in the supporting Technical Reference Manual. When possible, this toxicity value should be considered in a weight of evidence approach.

Amides :

------- No limitations known at this time.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: >8.5 (LC50) Maximum LogKow: >8.0 (EC50,ChV)

Maximum Mol Wt: 1000

Pyrazoles/Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemi cal is greater than 5.0, or if the compound is solid and the LC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4 , or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

### 114 4. ECOSAR Results fo r PAM using ESTIMATED Log Kow of 1.68 SMILES : NC(=O)c1c(CL)c(CC)nn1C

CHEM : PAM

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C7 H10 CL1 N3 O1

MOL WT : 187.63 Log Kow: 1.68 (KowWin estimate)

Melt Pt: Wat Sol: 1869 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------ Amides Pyrazoles/Pyrroles

Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========== ================ ================== ======== Amides : Fish 96

- hr LC50 43.539 Amides : Daphnid 48

- hr LC50 21.932 Amides : Green Algae 96

- hr EC50 0.507

Amides : Fish ChV 0.257 Amides : Daphnid ChV 0.289 ! Amides : Green Algae ChV 0. 313

Pyrazoles/Pyrroles : Fish 96

- hr LC50 1.943 Pyrazoles/Pyrroles : Daphnid 48

- hr LC50 2.799 Pyrazoles/Pyrroles : Fish ChV 0.216 ! Pyrazoles/Pyrroles : Daphnid ChV 0.224 !

=========================== ================== ======== Neutral Organic SAR : Fish 96

- hr LC50 271.434 (Baseline Toxicity) : Daphnid 48

- hr LC 50 150.621

: Green Algae 96

- hr EC50 56.866

: Fish ChV 25.952 : Daphnid ChV 13.139 : Green Algae ChV 19.400

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted effect.

### 115

Note: ! = exclamation designates: The toxicity value was determined from a predicted SAR using established acute

- to

- chronic ratios and ECOSAR regression techniques which are documented in the supporting Technical Reference Manual. When possible, th is toxicity value should be considered in a weight of evidence approach.

Amides :

------- No limitations known at this time.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: >8.5 (LC50) Maximum LogKow: >8.0 (EC50,ChV)

Max imum Mol Wt: 1000

Pyrazoles/Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemical is greater than 5.0, or if the compound is solid and the LC50 exceeds the water solubility by 10X, no effects at satur ation are predicted for these endpoints.

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4, or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

### 116 5. ECOSAR Results for PCA using ESTIMATED Log Kow of 2.17

SMILES : OC(=O)c1c(CL)c(CC)nn1C

CHEM : PCA

CAS Num:

ChemID1:

ChemID2:

ChemID3:

MOL FOR: C7 H9 CL1 N2 O2

MOL WT : 188.61 Log Kow: 2.17 (KowWin estimate)

Melt Pt: Wat Sol: 700 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------ Pyrazoles/Pyrroles

- acid

Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ========

-- > Acid moeity found: Predicted values multiplied by 10

Pyrazoles/Pyrroles

- acid : Fish 96

- hr LC50 10.406 Pyrazoles/Pyrroles

- acid : Daphnid 48

- hr LC50 18.275 Pyrazoles/Pyrroles

- acid : Fish ChV 1.193 ! Pyrazoles/Pyrroles

- acid : Daphnid Ch V 1.368 !

=========================== ================== ======== Neutral Organic SAR : Fish 96

- hr LC50 104.292 (Baseline Toxicity) : Daphnid 48

- hr LC50 61.431

: Green Algae 96

- hr EC50 28.400

: Fish ChV 9.863 : Daphnid ChV 5.847 : Green Algae ChV 10.603

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted effect.

Note: ! = exclamation designates: The toxicity value was determined from

a predicted SAR using established acute

- to

- chronic ratios and ECOSAR regression techniques which are documented in the supporting Technical

### 117

Reference Manual. When possible, this toxicity value should be considered in a weight of evidence appr oach.

Pyrazoles/Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemical is greater than 5.0, or if the compound is solid and the LC50 exceeds the water solubility by 10X, no effects at saturation are pr edicted for these endpoints.

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4, or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpo ints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limit ations:

---------------------------- Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

6. ECOSAR Results for PT(A)

- 4

- OH using ESTIMATED Log Kow of 3.37 SMILES : CCc1nn(C)c(C(=O)NCc2ccc(O)cc2)c1CL CHEM : (PT(A)

- 4

- OH)

CAS Num:

ChemID1:

ChemID2:

### 118

ChemID3:

MOL FOR: C14 H16 CL1 N3 O2

MOL WT : 293.76 Log Kow: 3.37 (KowWin estimate)

Melt Pt: Wat Sol: 67.2 mg/L (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------ Phenols

Amides

Phenol Amines Pyrazoles/Pyrrol es Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ======== ====== ========== Phenols : Fish 96

- hr LC50 4.347

Phenols : Fish 14

- day LC50 14.579 Phenols : Daphnid 48

- hr LC50 2.571

Phenols : Green Algae 96

- hr EC50 10.350

Phenols : Fish 30

- day ChV 0.491

Phenols : Fish 60

- day ChV 0.009 Phenols : Daphnid 21

- day ChV 0.488 Phenols : Green Algae ChV 4.779 Phenols : Fish (SW) 96

- hr LC50 1.391

Phenols : Earthworm 14

- day LC50 75.119 *

Phenols : Lemna Gibba 7

- day EC50 2.359

Amides : Fish 96

- hr LC50 3.120 Amides : Daphnid 48

- hr LC50 2.821

Amides : Green Algae 96

- hr EC50 0.268

Amides : Fish ChV 0.018 Amides : Daphnid ChV 0.037 !

Amides : G reen Algae ChV 0.491

Phenol Amines : Fish 96

- hr LC50 3.276 Phenol Amines : Daphnid 48

- hr LC50 1.014 Phenol Amines : Green Algae 96

- h r EC50 1.524

Phenol Amines : Fish ChV 0.076 ! Phenol Amines : Daphnid 21

- day ChV 0.084 Phenol Amines : Green Algae ChV 0.347

Pyrazoles/Pyrroles : Fish 96

- hr LC50 0.351 Pyrazoles/Pyrroles : Daphnid 48

- hr LC50 0.997 Pyrazoles/Pyrroles : Fish ChV 0.043 ! Pyrazoles/Pyrroles : Daphnid ChV 0.064 !

=========================== ================== ======== Neutral Organic SAR : Fish 96

- hr LC50 15.679 (Baseline Toxicity) : Daphnid 48

- hr LC50 10.677

: Green Algae 96

- hr EC50 8.076

: Fish ChV 1.444 : Daphnid ChV 1.256 : Green Algae ChV 3.754

Note: * = asterisk designates: Chemical may not be soluble

### 119

enough to measure this predicted effect.

Note: ! = exclamation designates: The toxicity value was determined from a predicted SAR using established acute

- to

- chronic ratios and ECOSAR regression techniques which are documented in the supporting Technical Reference Manual. When possible, this toxicity value should be considered in a weight of evidence approach.

Phenols:

------- For All Acute and Chronic Toxicity Values: If the log Kow of the chemical is greater than the value listed below, or if the compound is solid and the LC50, EC50 or ChV exceeds the water solubility by 10X, no effects at

satur ation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 7.0 (Fish 96

- hr LC50, Daphnid LC50) Maximum LogKow: 6.4 (Fish 14

- day LC50, Earthworm, Lemna) Maximum LogKow: 7.0 (Green Algae EC50 Maximum LogKow: 8.0 (ChV) Maximum LogKow: 5.0 (Fish (SW) 96

- hr LC50, Mysid)

Maximum Mol Wt: 1000

Amides :

------- No limitations known at this time.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: >8.5 (LC50) Maximum LogKow: >8.0 (EC50,ChV)

Maximum Mol Wt: 1000

Phenol Amines :

-------------- For All Acute and Chronic Toxicity Values: If the log Kow of the chemical is greater than the value listed below, or if the compound is solid and the LC50, EC50 or ChV exceeds the wate r solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50) Maximum LogKow: 7.0 (Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50 Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Pyrazoles/Pyrroles :

------------------- For Fish and Daphnid Acute Toxicity Values: If the log Kow of the chemical is greater than 5.0, or if the compound is solid and the LC50 exceeds the

water solubilit y by 10X, no effects at saturation are predicted for these endpoints.

### 120

For Green Algae Acute Toxicity Values: If the log Kow of the chemical is greater than 6.4, or if the compound is solid and the EC50 exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

For All Chronic Toxicity Values: If the log Kow of the chemical is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted for these endpoints.

ECOSAR v1.00 SAR Limitations:

---------------------------- Maximum LogKow: 5.0 (LC50) Maximum LogKow: 6.4 (EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

Baseline Toxicity SAR Limitations:

--------------------------------- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

### 121



## Appendix H

Endangered Species Policy and Considerations

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, and the United States Fish and Wildlife Service (USFWS) for listed wildlife and freshwater organisms, i f they are proposing an "action" that may affect listed species or their designated critical habitat. Each federal agency is required under the Act to ensure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued ex istence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirec tly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02).

To facilitate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly appreciably reduce the likelihood of both the survival and recovery of a l isted species in the wild by reducing the reproduction, numbers, or distribution of any listed species (USEPA 2004a). After the Agency’s screening

- level risk assessment is conducted, if any of the Agency’s listed species LOCs are exceeded for either

direc t or indirect effects, an analysis is conducted to determine if any listed or candidate species

may co

- occur in the area of the proposed pesticide use or areas downstream or downwind that

could be contaminated from drift or runoff/erosion. If listed or ca ndidate species may be present in the proposed action area, further biological assessment is undertaken. The extent to which listed species may be at risk is considered, which then determines the need for the development of a more comprehensive consultati on package, as required by the Endangered Species Act.

The federal action addressed herein is the proposed registration of new uses for tolfenpyrad. It is expected that the new uses of tolfenpyrad will occur nationwide.

### 122

5.3.1 Action Area

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by tolfenpyrad use and not merely the immediate area where tolfenpyrad is applied. At the initial screening

- level, the risk as sessment considers broadly described taxonomic groups and conservatively assumes that listed species within those broad groups are co

- located with the pesticide treatment area. This means that terrestrial plants and wildlife are assumed to

be located on o r adjacent to the treated site and aquatic organisms are assumed to be located in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area, which has the relatively highest po tential exposure to the pesticide, and that exposures are likely to decrease with distance from the treatment area.

Section 5.3.4 of this risk assessment presents the proposed pesticide use sites that are used to

establish initial co

- location of species w ith treatment areas.

5.3.2 Taxonomic Groups Potentially at Risk

If the assumptions associated with the screening

- level action area result in RQs that are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary. Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects on listed species that depend upon the taxonomic group fo r which the RQ was calculated. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species, the locations of

these s pecies, and the locations of use sites are considered to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentially include areas of exposure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, the conceptual models addressing the proposed new tolfenpyrad u ses, and the associated exposure and effects analyses conducted for the tolfenpyrad screening

- level risk assessment are in Sections 3 to 4 . The assessment endpoints used in the screening

- level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and growth of non

- target aquatic and terrestrial plant species from exposure via spray drift and runoff. These assessment endpoints address th e standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action it authorizes does not appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQ values) integrating exposure and effects are calculated for broad

- based taxonomic groups in the screening

- level risk assessment and are presented in Section 5.

### 123

Both acute and chronic risk to li sted species LOCs are considered in the screening

- level risk assessment to identify direct and indirect effects to taxa of listed species. This section identifies direct and indirect effect concerns, by taxa, that are triggered by exceeding listed species LOCs in the screening

- level risk assessment ( Table 5.12 ). Data on exposure and effects collected under field (when available) and laboratory conditions are evaluated to make determinations on the predictive utility of the direct effect screening assessme nt findings to listed species.

### 124



## Appendix I

Bird Specie s U tilizing Proposed Crop areas for N esting
The following information is based on the American Bird Conservancy efforts to document the presence of various species by agricultural areas as recorded in surveys and published open literature. Both the county locations and time of year are included for these observations, but the summaries below were shortened to simply illustrate the species which may be exposed from proposed uses of Tolfenpyrad. It

should not be considered a comprehensive list for all potential bird species that might nest in these crop areas, but rather an indication of the diversity of species that utilize crop areas for nesting and brood rearing of young.

Birds Observed Nesting in Citrus Groves

Common Ground

- Dove, Common Nighthawk, Common Pauraque, Eastern meadowlark, Eastern

To whee, Great tailed Grackle, Inca dove, Loggerhead shrike, Long billed thrasher, Mourning dove, Northern bobwhite, Northern Cardinal, Northern mockingbird, Red

- winged blackbird, White tipped dove, White winged dove, Yellow

- billed cuckoo. In addition, 46 species were observed foraging in citrus

groves

Bird Species Observed Nesting in Orchard Crops American crow, American goldfinch, American redstart, American robin, Baltimore oriole, Barn swallow, Black

- billed cuckoo, Black crowned Night Heron, Brown thr asher, Brown

- headed cowbird, Cassin’s Kingbird (brood rearing and nesting), Cedar waxwing, Chipping sparrow, Common grackle, Common ground dove, Dickcissel, eastern bluebird, Eastern Kingbird, Eastern towhee, European starling, Gray catbird, House finch, House wren, Least flycatcher, Loggerhead shrike, Mourning dove, Northern cardinal, Northern mockingbird, Orange

- crowned Warbler, Red

- winged Blackbird, Savannah Sparrow, Song Sparrow, Tree Swallow, Western Kingbird, White

- tailed Kite, Wood thrush In add ition, 162 species were observed foraging in orchards

Bird Species Observed Nesting in Pome Fruit Orchards American Crow, American Goldfinch, American Redstart, American Robin, American woodcock (brood rearing), Baltimore Oriole, Barn Swallow, Black

- billed Cuckoo, Brown Thrasher, Brown

- headed Cowbird, Cassin's Kingbird (nesting and brood rearing), Cedar Waxwing , Chipping Sparrow, Common Grackle, Eastern Bluebird, Eastern Towhee, European Starling, Gray Catbird, House Finch, House Wren, Indigo Bunting (nesting and brood Rearing), Least Flycatcher, Loggerhead Shrike, Mourning Dove, Northern Cardinal, Northern Mock ingbird, Orange

- crowned Warbler, Savannah Sparrow, Song Sparrow, Tree Swallow, Western Kingbird (nesting and brood rearing), Wood thrush, In addition, 133 species were observed foraging in pome fruit orchards

Bird Species Observed Nesting in Stone fru it Orchards American crow, American robin, Dickcissel with 30 species observed foraging in stone fruit orchards.

Birds Observed Nesting in Nut Crop Orchards American Crow, with 15 species observed foraging in nut crops

Birds Observed Nesting in Fruiting vegetables and Curcurbits Mottled duck with 12 species observed foraging in these crops



### Birds Observed Nesting in Cotton Greater prairie chicken (Aransas County, TX; Refugio County, TX)

### 125