### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### Date: September 03, 2014 OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION



### Subject: Benzovindiflupyr: Occupational and Res id ential Exposu re and Risk Assessment

for the Propo sed Uses of the New Fungicide

, on Cereals, Blueberries, Com

, Cotton, Cucurbits, Fruitin g v egetables, Small Fruit V i nes climbing subgroup (except fuzzy kiwifruit), Legume Vegetab l es, Peanuts, Pome fruit, Rapeseed,

Tuberous and Corm, Ornamentals Crops and Turf grass

.

PC Code: 12230 5 Registration Nos.: I 00-1, 100 -2, I 00-3, 100-4,

100-5

, 100-6, 100-7, 100 -8 andl00-9

Petition No.:

Risk Assessment Type: Occupational / Residential Exposure Assessment

TXRNo.:NA

MRID No.: NA



### From: Seyed Tadayon,

# Chemist**~~** Risk Assessment Branch ;/

Health Effects Division (7509P)

Office of Pesticide Programs DP Barcode: 0421981

Decision No.: 473382

Regulatory Action: Section 3

Case No.: NA

CAS No.: 1 072957-7 1- 1
40CFR : NA



### ExpoSAC Reviewer, Bridgett Bobowiec

## ~**~** ExpoSAC Reviewer, Kell y Lowe

### ~ Exposure Sc i ence Advisory Committee (Exp5SAC) I 

### HED

THROUGH: Michael S. Metzger, Branch Chief 

# u /)

fJ

# . 

# Kt

- ·-

Risk Assessment Branches V and V I 

# {;t(tH 

# A

Health Effects Division (7509P)

Office of Pesticide Programs

TO: Danette Drew, Senior Risk Assessor

Risk Assessment Branch V

Health Effects Division (7509P)

Office of Pesticide Programs

Page 1 

### of27

### Introduction

The Registration Di vision (RD) requested that the Health Effects Division (HED) conduct an occupationa l and residential exposure and risk assessment for all of the proposed uses of a

new fungicide, benzovindiflupy r, including agricultural uses on wheat, triticale, barley,

r ye, oat, blueberries (nonbearing), com
, cotton, cucurbits, fruiting vegetables, small fruit vines climbing subgroup (except fuzzy kiwifruit),legume vegetables, peanuts

, pome fruit, rapeseed
(canola), tuberous and corm vegetab les

, ornamentals (greenhouses and outdoor nurseries and turfgrass (including sod farms)).



### It is HED policy to use the best avai l able data to assess exposure. Several so urces of gene ri c data were used in this assessme nt as surrogate data in the absence of chemical-specific data, including Pesticide Handlers Exposure Database Version 1.1 (PHED I. I) ; the Agricultural

Handler Expo sure Task Force (AHETF) database ; the Outdoor Re sidential Exposure Task Force ( ORETF) data set) and the Residential SOPs (Lawns!Turt). Some of these data are propr ie tary,

and subject to the data protection prov i s i ons of the Federa l I nsecticide

, Fungic i d e, and

Rodenticide Act (FIFRA).

Note : T hi s memorandum was r eviewe d by the Exposu re Science Advisory Committee (ExpoSAC) on 8/21 / 2014

.

P age 2 of27

### Page 3 of 27 Table of Contents

1.0 Executive Summary

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

2.0 Conclusions/Regulatory Recommendations/Data Deficiencies

................................ .......... 6

2.0 Risk Assessment Conclusions and Recommendations

................................ ........................ 6

2.1 Summary of Risk Estimates

................................ ................................ ............................. 6

2.2 Label Recommendations from Occupational Assessment

................................ ............... 6

2.3 Label Recommendations from Residential Assessment

................................ .................. 6

2.4 Data Deficiencies and Requirements

................................ ................................ ............... 6

3.0 Hazard Characterization

................................ ................................ ................................ ....... 7

4.0 Use Profile

................................ ................................ ................................ ........................... 9

5.0 Residentia l Exposure and Risk Estimates

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

5.2 Residential Risk Estimates for Use in Aggregate Assessment

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

5.4 Spray Drift

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

5.5 Residential Bystander Post

- Application Inhalation Exposure

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

6.0 Occupational Exposure and Risk Estimates

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

6.1 Agricultural Occupational Handler Exposure/Risk Estimates

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

6.2 Occupational Post

- application Exposure/Risk Estimates

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

6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

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

6.3 Restricted Entry Interval

................................ ................................ ................................ 22 Appendix A. Summary of Occupational Handler Non

- Cancer Algorithms

................................ 24 Appendix B. Summary of Residential Post

- Application Non

- Cancer Algorithms

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

### Page 4 of 27

1.0 Executive Summary

Benzovindiflupyr is a member of the SDHI ( Succinate D ehydrogenase Inhibitors )

. Review of the submitted petition is being conducted as a tri

- lateral review work

- share effort which will be carried out in part with Canada (PMRA) and the Mexico. Benzovindiflup yr
, also known as
SolatenolTM

, is a broad spectrum foliar fungicide for control of certain diseases on cereals (wheat, triticale, barley, rye and oat), blueberries (non

- bearing), corn, cotton, cucurbit vegetables, fruiting vegetables, small fruit vines climbing (except fuzzy kiwifruit )

, legume vegetables, peanuts, pome fruit, rapeseed (Canola), tuberous and corm vegetables , turf grass and

on o rnamentals (greenhouses and outdoor nurseries)

.

Eight formulated end

- use products were evaluated in this assessment including emulsifiable concentrations (ECs) and w ater dispersible granules (WDG s )

.

Proposed Use Profile Benzovindiflupyr may be applied via broadcast application including aerial

, chemigation, airblast or groundboom application on various crops at the maximum single application rate of The maximum application rate for all uses is 0. 089 lb ai/A

, 0. 236 lb ai/1000 ft 2 

### or 0.0068 lb ai/gallon. The proposed labels require occupational h andlers to wear the following personal protective equipment (PPE): long

- sleeved shirts, long pants, chemical resistant gloves, coveralls and protective eyewear. The 12 hour restricted entry interval (REI) listed on the labels is appropriate.

Exposure P rofile For the proposed use sites, there is a potential for short

- term and intermediate

- term occupational

exposure to b enzovindiflupyr during mixing, loading, applying, and other handling tasks; and during post

- application activities. There is potential f or short

- term residential exposure during handling and post

- application activities from the registered uses of b enzovindiflupyr on turf, parks, golf courses, sod farms, nurseries and ornamental plantings. C hronic exposure is not expected for the proposed agricultural uses because of the b enzovindiflupyr use

- pattern. Although b enzovindiflupyr will be registered for use on a number of crops for multiple applications, the retreatment intervals range from 7 days to 21 days for most uses, limiting the potentia l for continuous occupational exposure. Additionally, s ince the same endpoint and point of departure were selected for short

- and intermediate

- term durations, short

- term exposure and risk estimates are considered to be protective of intermediate

- term expo sure and risk.

Hazard Concerns

Estimated short

- and intermediate

- term inhalation and short

- term incidental oral exposures were compared to the oral no observed adverse effect level (NOAEL) of 8.2 mg/kg/day from a rat reproduction toxicity study in which decreased body weight and food consumption was observed at the lowest observed adverse effect level (LOAEL) of 19.4 mg/kg/day. In the 28

- day dermal toxicity study in rats, no dermal or systemic toxicity was seen up to the limit dos e (1,000 mg/kg/day); therefore, a dermal non

- cancer exposure assessment is not required for

b enzovindiflupyr

.

### Page 5 of 27

The CARC committee determined based on a weight

- of

- evidence approach of the overall tumor profile that b enzovindiflupyr should have a cancer cla ssification of “ Suggestive Evidence of Carcinogenic Potential ”

.

The level of concern (LOC) for both occupational and non

- occupational risk is for margins of exposure (MOEs) less than 100. For non

- cancer and cancer risk assessment, inhalation exposure

is assumed to be equivalent to oral absorption. Benzovindiflupyr has h igh acute toxicity via the oral (Toxicity Category I I) route of exposure

, and moderate toxicity via the dermal (Toxicity Category III) and inhalation (Toxicity Category I II ) routes of exposure. Benzovindiflupyr produces moderate eye irritation and is not a dermal irritant or sensitizer.

Residential Exposure and Risk There are residential uses purposed in this petition. The purposed b enzovindiflupyr labels

indicate that they are to be used on established ornamental turf lawns, parks, golf courses, nurseries and ornamental plantings. Because the labels specify nursery grown ornamentals, and

to avoid drift of b enzovindiflupyr on susceptible plants such as flowers, ornament al trees, shrubs, and other desirable plants, a residential handler assessment has only been conducted for use on

turf. Residential exposure and risks from use on turf were assessed using the 2012 HED

Residential SOPs. All residential handler non

- cancer inhalation risk estimates were not of concern and the MOEs ranged from 180 ,000 to 20,000,000

. All residential post

- application incidental oral estimated MOEs ranged from 8 ,000 to 3

, 6 00,000, and were not of concern to

HED.

Occupational Exposure and Risk The occupational handler exposure and risk estimates indicate that short

- and intermediate

- term

non

- cancer inhalation MOEs are not of concern to HED (i.e., MOEs > 100) with baseline attire (i.e., no respirator) . With baseline attire, the inhalation MOEs for all handler scenarios for

b enzovindiflupyr application to all purposed uses ranged from 9 00 to 10 ,000,000.

Non

- cancer post

- application risks were not assessed because adverse effects were not seen in the

28

- day dermal toxicity study up to the Limit Dose (1,000 mg/kg/day). Based on the Agency's current practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for b enzovindiflupyr at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post

application inhalation exposure assessment for b enzovindiflupyr

. The 12 hour restricted entry interval (REI) listed on the labels is appropriate.

Human Studies Review

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Agricultu ral Handler Exposure Task Force (AHETF) database and

, the Residential SOPs (lawns and turf)

, and are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements. For certain studies that review may have included review

### Page 6 of 27

by the Human Studies Review Board. Descriptions of data sources as well as guidance on their

use can be found at http://www.epa.gov/pesticide s/science/handler

- exposure

- data.html and http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html

. 2.0 Risk Assessment Conclusions and Recommendations

There are no occupational/residential risk estimates of concern associated with the proposed new

uses of b enzovindiflupyr

.

2.1 Summary of Risk Estimates

Occupational Exposure and Risk Estimates The results of the occupational handler exposure and risk assessment i ndicate that short

- and

intermediate

- term inhalation risks do not exceed HED’s LOC (i.e. an MOE < 100 for short

- term exposures and intermediate

- term exposures) at baseline mitigation (no PPE). Since the short

and intermediate

- term PODs are the same, the inhalation MOEs are also the same, ranging from

9 00 to 10,000,000 . Dermal handler and post

- application exposure and risk assessments were not

conducted because a dermal hazard was not identified for b enzovindiflupyr

.

Residential Exposure and Risk Estimates The results of the residential handler exposure and risk assessment indicate that short

- term inhalation risks do not exceed HED’s LOC (i.e. an MOE < 100 ). Handler risk estimates for all

scenarios are not of concern. Short

- term inhalation MOEs r ange from 180 ,000 to 20,000,000

. Although residential dermal exposure is expected following the treatment of turf, a quantitative

post

- application dermal risk assessment was not conducted because a dermal hazard was not

identified for b enzovindiflupyr

. Short

- term incidental oral post

- application risk estimates for all scenarios are not of concern to HED ( MOEs range from 8 ,000 to 3

, 6 00,000) because they exceed the level of concern (LOC) for incidental oral exposure (i.e. an MOE < 100)

.

2.2 Label Recommen dations from Occupational Assessment

There are no label recommendations based on the occupational assessment.

2.3 Label Recommendations from Residential Assessment

There are no label recommendations based on the residential assessment.

2.4 Data Defici encies and Requirements

There are no data deficiencies or data requirements for the new active ingredient,

b enzovindiflupyr

.

The b enzovindiflupyr database lacks a turf transferable residue (TTR) study. In accordance with the updated Part 158 data requirements (2007), a TTR study is required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses . As part of the Revised Residential SOPs, HED analyzed all of the available TTR data and selected new liquid

### Page 7 of 27

and granular default values for the fraction of the application rate available for transfer after a turf application (FAR). This default is 1% fo r formulations applied as liquids; the proposed uses only apply to liquid formulations of b enzovindiflupyr . Of the available TTR studies submitted to the Agency, the maximum FAR value seen using a liquid product was 6.1% or 6.1 times higher

than the defau lt residue transfer value. Therefore, HED decided that a calculated MOE of approximately 10 times higher than the LOC (e.g., an MOE > 1,000 if the LOC = 100) using the default residue transfer values would provide an adequate margin of safety for any pote ntially higher residues seen in a chemical

- specific TTR study (Guidance for Requiring/Waiving TTR and DFR Studies, 06/07/2012). A TTR study is not required for b enzovindiflupyr at this time

since the incidental oral MOEs for children is > 8,000

.

The b enz ovindiflupyr database also lacks dislodgeable foliar residue (DFR) studies. In accordance with the updated Part 158 data requirements (2007), one or more DFR studies are required when a pesticide has residential or occupational uses that could result in p ost

application dermal exposure. Because there is no hazard via the dermal route of exposure, a non

cancer dermal post

- application risk assessment was not performed for b enzovindiflupyr

. Therefore, DFR studies are not needed for b enzovindiflupy r at this time. If the PODs change, the need for DFR studies may be reevaluated in the future to refine the post

- application

assessment.

3.0 Hazard Characterization Acute Toxicity The acute toxicity of b enzovindiflupyr is summarized in Table 3.1.

Table 3.1. Summary of Acute Toxicity Data for B enzovindiflupyr

Guideline [OCSPP] Study Title Results Toxicity Category

870.1100 Acute Rat Oral Toxicity Study

(2010, MRID 48604427) Up

- Down Method 17.5 (N=1), 55 (N=4), 175 (N=3) mg/kg LD 50 =66.3 mg/kg (HED calculation)

Note: The LD 50 value for hydroxy

b enzovindiflupyr (SYN546039) is >2000 mg/kg (MRID 48604458), putting doubt on this LD 50 value for b enzovindiflupyr . Animals were fasted prior to dosing, which can sensitize them to

mitochondrial toxins. At th e dose of 55 mg/kg, there were only 1 of 4 animals died, which is not 50% lethality. II

870.1200 Acute Rat Dermal Toxicity

(2010, MRID 48604428) LD 50 >2000 mg/kg III

870.1300 Acute Rat Inhalation Toxicity Study

(Nose

- Only) (2010, MRID 48604429 ) LC 50 > 0.56 mg/L III

870.2400 Primary Rabbit Eye Irritation Study

(2011, MRID 48604431 ) Moderately Irritating III

870.2500 Primary Rabbit Skin Irritation Study

(2010, MRID 48604430 ) Mild Irritant IV

870.2600 Local Lymph Node Assay, Mouse

(2010, MRID 48604432 ) Non

- Sensitizer NA

### Page 8 of 27

Toxicological PODs Used for Risk Assessment

HED has selected PODs for use in occupational and residential risk assessment and has concluded that, based on the available hazard and exposure data

, the Food Quality Protection Act (FQPA) safety factor is reduced to 1 X for all population subgroups and e xposure scenarios.

The toxicological PODs and endpoints for b enzovindiflupyr are summarized in Table 3.2

. Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.

Toxicological PODs Used for Risk Assessment

Table 3.2. Summary of Toxicological Doses and Endpoints for B enzovindiflupy r Use in Residential and Occupational Human Health Risk Assessments

Exposure/

Scenario Point of

Departure Uncertainty/FQP

A Safety Factors RfD, PAD,

Level of

Concern for

Risk

Assessment Study and Toxicological Effects

Incidental Oral

Short

- Term (1

- 30 days)

Inhalation

Short

- Term (1

- 30 days) and

Intermediate

Term (1

- 6 months) NOAEL =

8.2 ( fe males) mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Residential

and occupational

LOC

MOE = 100 Reproduction Study , Parental Effects :

NOAEL: 6.8 mg/kg/day (M), 8.2 mg/kg/day (F)

LOAEL: 40.5 mg/kg/day (M), 19.4 mg/kg/day (F) due to decreased body weight, decreased body weight gain, and decreased food consumption.

Dermal Short

Term (1

- 30 days)

and Intermediate

Term (1

- 6 months) A POD and endpoint of concern is not recommended and quantification of dermal risk is not

required since no systemic or dermal toxicity was seen following repeated dermal applications of

b enzovindiflupyr a t the Limit Dose (1000 mg/kg/day) to rats for 28 da ys. Additionally, there are no concerns for developmental, reproductive, neuro, or Immunotoxicity

.

Cancer (oral, dermal, inhalation) The CARC committee determined based on a weight

- of

- evidence approach of the overall tumor profile that b enzovindiflupyr should have a cancer classification of “ Suggestive Evidence of Carcinogenic Potential ”

. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short

- term study for long

- term risk

assessment. UF DB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.



### Absorption Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equival ent to the estimated toxicity by the oral route of exposure.

Body Weight

### Page 9 of 27

The standard body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoints selected were not developmental an d/or fetal

effects.

4 .0 Use Profile

There are numerous end

- use product labels purposed with b enzovindiflupyr as the active ingredient. These include liquid and water dispersible granular formulations

. The labeled use sites include various agricultural crops, golf courses, n urseries, landscape ornamentals, residential/commercial turf, and sod farms. The purposed uses are soil or foliar application

, and are applied either via aerial, airblast, chemigat ion, groundboom or handheld equipment. The maximum application rate s for all uses is 0. 089 lb ai/A (0. 236 lb ai/1000 ft 2 

### or 0.0 068 lb ai/gal).

The REI for all the proposed uses is 12 hours.

Based on the proposed use patterns, it has been determine d that the potential exposure scenarios

that will need to be assessed include short

- and intermediate

- term occupational and residential exposures (handler and post

- application). A summary of the proposed use directions are

included in Table 4.1 and 4.2 be low.

Syngenta Crop Protection, Inc purposed the following products for registration:

Table 4.1 Summary of purposed labels for Benzovindiflupyr Products

Product N a me/Formulation Regi s tr a tion No Acti v e Ingredient Us e s

Benzovi n difl u pyr Tec h nical 100

- 1 Benzovindiflupyr Crop, T urf

&orn a menta l

s A15457/ Emulsifiable Concentrate 100

- 2 Benzovindiflupyr Crop
A1 5 457 L G/ Emulsifiable Concentrate 100

- 3 Benzovindiflupyr Turf

A18126/ Water Dispersible Granular 100

- 4 Benzovindif l upyr + Azoxys t robin Crop

A18126LG/ Water Dispersible Granular 100

- 5 Ben z ovindiflupyr + Azoxys t robin Turf

MUR A LTM/ Water Dispersible Granular 100

- 6 Benzovindiflupyr + Azoxys t robin Ornamenta l s
A18993/ Emulsifiable Concentrate 100

- 7 Benzovindiflu p yr + prop i conazole Crop

A19334/ Emulsifiable Concentrate 100

- 8 Benzovindiflu p yr+ difenoconazole Crop

ASCERNIT Y TM/ Water Dispersible Granular 100

- 9 Benzovindiflupyr+ difenoconazole Turf



### Mixture of benzovindiflupyr and current registered uses (sa m e use p atter n s) of azoxystro b in, propiconazole and difenoconazole are purpose d to be used on agricultural crops

, turf and

ornamentals.

### Page 10 of 27

Table 4. 2 . Summary of Proposed Directions for Use of B enzovindiflu p yr Crop s Maximum Product Rate/A/application (fl oz/A) /

l b ai/A Maximum total

fl oz/A/

season /Number of application Pre

- Harvest

Interval (PHI) (days) Minimum Re

treatment Interval (days)

Emulsifiable Concentrate F ormulation Products (A15457, A19334, A18993)

Blueberries ( non

- bearing) 10.5/0.068 or 0.0068lb ai/gal (label recommends 10 gallons /A dilution) 21/2 365 10

Canola 10.5/1 30 NA

Cereals (wheat, triticale, barley, rye and oat) 21/2 7 14

Corn 42/4 7 7

Corn, sweet 42/4 7 7

Cotton 31.5/3 45 10

Cucurbits 42/4 0 7

Fruiting Vegetables (tomatoes/peppers) 42/4 0 7

Grapes 42/4 21 7

Legumes (6C) 21/2 14 14

Soybeans 21/2 14 7
Tuberous and Corm subgroup 1C (potatoes)

foliar 42/4 14 7

Peanuts 13.7/0.089 (label recommends 10 gallons /A dilution) 41/3 30 14

Tuberous and Corm subgroup 1C (potatoes) soil 42/4 14 7

Pome 7/0.046 27.6/4 30 7

Turf 10.3/0.067

or 0.236/1000ft 2
(0.0015lb ai/1000ft 2 )

or 0.0023 1 b ai/gal (label recommends 30 gallons /A dilution) 41.4/4 NA 14

- 21

Ornamentals 10.5/0.068

o r 0.00068 lb ai/gal (label recommends 100 gallons /A dilution) 28/3 NA 7

- 21

Water Dispersible Formulation Products(MURAL TM

, A18126)

Blueberries (non

- bearing) 7.3/0.068 (label recommends 10 gallons /A dilution) 14.5/2 365 10

Cereals (wheat, triticale, barley, rye and oat) NA 14

Corn 29/4 7 7

Corn, sweet 29/4 7 7

Cotton 21.3/3 45 14

Cucurbits 29/4 1 7

Fruiting Vegetables (tomatoes/peppers) 29/4 0 7

Grapes 29/4 21 10

Legumes (6C) 14.5/2 14 14

Soybeans 14.5/2 14 7

Tuberous and Corm subgroup 1C (potatoes)

foliar 14.5/2 14 7

Peanuts 9.5/0.089 28.5/4 30 14

Tuberous and Corm subgroup 1C (potatoes) soil 14 7

### Page 11 of 27

Table 4. 2 . Summary of Proposed Directions for Use of B enzovindiflu p yr Crop s Maximum Product Rate/A/application (fl oz/A) /

l b ai/A Maximum total

fl oz/A/

season /Number of application Pre

- Harvest

Interval (PHI) (days) Minimum Re

treatment Interval (days)

Turf NA NA NA NA

Ornamental 7/0.067 or 0.00067 lb ai/gal (label recommends 100 gallons /A dilution) 28/4 NA 7

- 21



### 5.0 Residential Exposure and Risk Estimates

There are proposed residential uses with this action. The residential uses of b enzovindiflupyr

will result in residential handler and post

- application exposure in residential settings. The

b enzovindiflupyr labels indicate that they can be used on residential ornamental turf, parks, athletic fields, golf courses, established ornamental plantings, and sod farms. Therefore, residential exposure has been assessed i n this document to reflect using HED’s 2012 Residential SOPs ( http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html )

. Because the labels specify nursery grown ornamentals, and to avoid drift of b enzovindiflupyr on the susceptible pla nts such as vegetables, flowers, ornamental trees, shrubs, and other desirable plants, a residential handler assessment has only been conducted for use on turf. Post

- application dermal exposure is anticipated; however, since there is no dermal hazard, a q uantitative assessment has

not been conducted. Post

- application inhalation exposure in outdoor settings is considered negligible ; therefore, only post

- application incidental oral exposure/risk to children has been

assessed . The following residential expos ure scenarios have been assessed :

Residential Handler:

 Mixing/loading/applying liquids with a manually pressurized handwand to turf and

ornamentals (0.002 3 lb ai/gal),

 Mixing/loading/applying liquids with a hose

- end sprayer to turf and ornamentals ( 0.067

lb ai/A )

,

 Mixing/loading/applying liquids using a sprinkler can to turf and ornamentals (0.0 015 lb

ai/ 1000 ft 2 

### ),

 Mixing/loading/applying liquids with a backpack sprayer to turf and ornamentals (0.002 3 lb ai/gal)

 Mixing/Loading/applying WDG with a h ose

- end s prayer to ornamentals (0.067 lb ai/ A )

,

 Mixing/loading/applying WDG with a manually pressurized handwand to ornamentals (0. 00067 lb ai/gal),

 Mixing/loading/applying WDG using a sprinkler can to ornamentals (0.0 015 lb ai/ 1000

ft 2 

### )

.

Residential Post

- Application:

 Hand

- to

- mouth exposure to treated turf,

 Object

- to

- mouth exposure to treated turf, and

 Treated soil ingestion.

### Page 12 of 27

Summary of Residential Handler Non

- Cancer Exposure and Risk Estimates

Table 5.1.1 presents the residential handler non

- cancer inhalation risk estimates for application to

turf . Residential handler inhalation MOEs were not of concern to HED, and ranged from

180 ,000 to 20

, 0 00,000

.

Table 5.1.1: Residential Handler Non

- cancer Exposure and Risk Estimates for B enzovindiflupyr

Exposure Scenario Level of

Concern Inhalation

Unit Exposure (mg/lb ai) Maximum

Application

Rate 1 Area

Treated or

Amount

Handled Daily 2 Inhalation

Dose (mg/kg/day) 3 MOE 4

Emulsifiable Concentrate (EC)

M/L/A with a Hose

- end Sprayer to Turf and

Ornamentals 100 0.022 0.06 7 lb ai/A 0.5 acres 0.000009 2 890,000

M/L/A with a Manually Pressurized Handwand to Turf

and ornamentals 100 0.018 0.002 3 lb ai /gal 5 gal 0.000002 6 3,200,000

M/L/A with a Sprinkler Can 100 0.022 0.0015/1000 lb

ai/ ft 2 1000 ft 2 0.000 000 41 20,000 ,000

M/L/A with a backpack sprayer to Turf and ornamentals 100 0.14 0.0023 lb ai /gal 5 gals 0.0000 2 410,000

Water Dispersible Granular (WDG)

M/L/A with a Hose

- end Sprayer to Ornamental 100 0.022 0.067 lb ai /A 0.5 acres 0.0000092 890,000

M/L/A with a Manually Pressurized Handwand to

Ornamentals 100 1.1 0.00067 lb

ai /gal 5 gal 0.000046 180,000

M/L/A with a Sprinkler Can to Ornamentals 100 0.022 0.0015/1000 ft 2 1000 ft 2 0.00000041 20,000,000

M/L/A with a backpack sprayer to Ornamentals 100 1.1 0.00067 /gal 5gals 0.000046 180,000

1 Based on purposed b enzovindiflupyr labels

. 2 Exposure Science Advisory Council Policy #9.1.

3 Inhalation Dose = Inhalation Unit Exposure ( μ g/lb ai) x Conversion Factor (0.001 mg/ μ g) x Application Rate (lb ai/acre or gal) x Area Treated or Amount Handled (A or gallons/day) / BW ( 80 kg).

4 Short

- Term Inhalation MOE = Short

- Term Inhalation NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day) where NOAEL = 8.2 mg/kg/day

.



### Summary of Residential Post

- Applica tion Non

- Cancer Exposure and Risk Estimates

Table 5.1. 2 presents the residential post

- application incidental oral exposure risk estimates from treated turf. Residential incidental oral risk estimates ranged from 8,000 to 3, 6 00 ,000, and were

not of concern to HED.

Table 5.1. 2 : Residential Post

- Application Non

- cancer Exposure and Risk Estimates for B enzovindiflupyr

Lifestage Post

- application Exposure Scenario Dose 1 MOEs 2

Child Turf

- sprays Hand to Mouth 0.0010 8,000
Object to Mouth 0.00003 1 260,000
Incidental Soil Ingestion 0.0000023 3,600,000

1 Hand

- to

- Mouth = [Hand residue loading (mg/cm 2 ) x (fraction hand surface area mouthed/event (0.127/event) x typical surface area of one hand (150 cm 2 )) x (exposure time (1.5 hrs/day)*number of replenishment intervals/hr (4 intervals/hr) x (1

- (1

- saliva extraction factor (0.5)^(number of hand

- to

- mouth contact events per hour (13.9 events/hr); Hand Residue Loading = (fraction of ai on hands compared to total

surface residue from dermal TC study (0.06) x dermal exposure (mg))/typical surface area of one hand (150 cm 2 ). Object

- to

- Mouth = ((Object Residue (μg/cm 2 ) x CF1 (1.0E

- 3 mg/μg) x Object Surface Area Mouthed/Event (10 cm 2 /event)) x (Exposure Time (1.5 hrs/day) x #Replenishment I ntervals/hr (4)) x (1

- ((1

- Extraction by Saliva (0.48))^(#Object

- to

- Mouth Events/hr (8.8 events/hr)/#Replenishment intervals/hr))))/Body Weight (11kg)

. Soil Ingestion = (Soil Residue (7.0746975 μg/g) x Ingestion Rate (50 mg/kg/day) x CF(0.0 00001))/Body Weight (11 kg).

2 MOE = NOAEL/Daily Dose (mg ai/kg/day); Oral NOA EL = 8.2 /kg/day.

### Page 13 of 27

5. 2 Residential Risk Estimates for Use in Aggregate Assessment

Table 5. 2 .1 reflects the residential risk estimates that are recommended for use in the aggregate

assessment for b enzovindiflupyr

.

 The inhalation exposure estimate from treating ornamentals with a m anually p ressurized

h andwand is recommended for inclusion in the non

- cancer aggregate assessment.

 Hand

- to

- mouth exposure of children 1 to <2 years old is recommended for inclusion in the aggregate assessment.

### Page 14 of 27 Table 5. 2 .1. Recommendations for the Residential Exposures for the Bezovindiflupyr Aggregate Assessment.

Lifestage Exposure Scenario Dose (mg/kg/day) 1 MOE 2

Dermal Inhalation Oral Total Dermal Inhalation Oral Total

Adult

Male Handler: Treating Turf NA 0.000046 N/A 180,000 NA 0.000046 N/A 180,000

Adult Female

Child NA NA NA HTM

0.0010 0.0010 NA NA 8,000 8,000

1 Dose = the highest dose for each applicable lifestage of all residential scenarios assessed . Total = dermal + inhalation + incidental oral

2 MOE = the MOEs associated with the highest residential doses . Total = 1 ÷ (1/Dermal MOE) + (1/Inhalation MOE) + (1/Incidental Oral MOE)

### Page 15 of 27

5

. 4 Spray Drift

Spray drift is a potential source of exposure to those nearby pesticide applications. This is particularly the case with aerial application, but, to a lesser extent, spray drift can also be a potential source of exposure from the ground application method s (e.g., groundboom and airblast) employed for b enzovindiflupyr

. The agency has been working with the Spray Drift Task Force (a task force composed of various registrants which was developed as a result of a

Data Call

- In issued by EPA), EPA Regional Offic es and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the agency’s Spray Drift website for more information ( htt p://www.epa.gov/opp00001/factsheets/spraydrift.htm ) . The agency has also developed a policy on how to appropriately consider spray drift as a potential source of exposure in risk assessments for pesticides. The potential for spray drift will be quantitat ively evaluated for each pesticide during the Registration Review process which ensures that all uses for that pesticide will be considered concurrently. The approach is outlined in the revised (2012) Standard Operating Procedures For Residential Risk Ass essment (SOPs)

- Residential Exposure Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift. This

document outlines the quantification of indirect non

- occupational exposure to drift.

5

. 5 Residential Bystander Post

- Application Inhalation Exposure

Volatilization of pesticides may be a source of post

- application inhalation exposure to individuals nearby pesticide applications. The agency sought expert advice and input on issues related to volatilization of pesticides from its F ederal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The agency has evaluated the SAP r eport and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html )

. During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, route

- specific inhalation toxicological studies) or further analysis is required for

b enzovindiflupyr

.

6.0 Occupational Exposure and Risk Estimates

6.1 Agricultural Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applica tions and exposures can vary depending on the specifics of each task. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure l evels to differ in a manner specific to each application event.

### Page 16 of 27

Based on the anticipated use patterns and current labeling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed agric ultural uses. The quantitative exposure/risk assessment developed for occupational handlers

is ba sed on several scenarios which include mixing/loading/applying liquid formulation of

b enzovindifl u pyr

. The use sites are summarized in Section 4.0. Methods of application include aerial, airblast, chemigation, groundboom, and handheld equipment. Refer to Table 6.1.1 for a

detailed list of each scenario.

 Mixing/loading liquids to support aerial applications,

 Mixing/loading liquids to support chemigation appli cations,

 Mixing/loading liquids to support groundboom applications,

 Mixing/loading liquids to support airblast applications

,

 Mixing/loading water dispersible granular to support aerial applications,

 Mixing/loading water dispersible granular to support ch emigation applications,

 Mixing/loading water dispersible granular to support groundboom applications,

 Mixing/loading water dispersible granular to support airblast applications

 Applying sprays with goundboom equipment,

 Applying sprays with aircraft,

 Applying sprays with airblast equipment,

 Flagging to support aerial spray applications,

 Mixing/loading/applying liquid and water dispersible granular via backpack,

 Mixing/loading/applying liquid and water dispersible granular via mechanically

pressurized handgun,

 Mixing/loading/applying liquid and water dispersible granular via manually

- pressurized

handwand

.

Occupational Handler Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational

h andler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate : Refer to the proposed use pattern table in Section 4.0.

Unit Exposures: It is the policy of HED to use the best available data to assess h andler exposure. Sources of generic handler data, used as surrogate data in the absence of chemical

- specific data, include PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant

- submitted occupation al exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit ex posures”, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 1 

### ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Age ncy website 2



### .

1 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pd f

2 Available: http://www.epa.gov/pesticides/science/handler

- exposure

- data.html

### Page 17 of 27

Area Treated or Amount Handled : The area treated or amount handled is b ased on HED Exp o SAC Policy No. 9.1. Refer to Table 6.1.1 for these assumptions for each scenario.

 1200 acres for aerial application to high acreage crops

,

 350 acres for aerial application to typical acreage crops

,

 60 acres for aerial and groundboom applications to nurseries

,

 200 acres for ground application to high acreage crops

,

 80 acres for ground application to typical acreage crops

,

 80 acres for ground applicatio n to sod farms

,

 40 acres for ground application to golf courses and field ground ornamentals

,

 350 acres for chemigation applications

,

 5 acres or 40 gallons for backpack and manually

- pressurized handwand applications

,

 5 acres or 1000 gallons for mechanically

- pressurized handgun

.

Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months

as intermediate

- term. Exposure duration is determined by many factors , including the exposed population, th e use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one

- month time frame; however, there may be a large agribusiness and/or commercial applicators who may apply a product over a period of weeks (e.g., completing multiple applications for mult iple clients within a region).

Mitigation/Personal Protec tive Equipment: Occupational handler exposure assessments are completed by HED using different levels of risk mitigation. Typically, HED uses a tiered approach. The lowest tier is designed as the baseline exposure scenario (i.e., long

- sleeve shirt, long pants, shoes, socks, no respirator). If risk estimates are of concern at baseline attire, then increasing levels of PPE (i.e., gloves, respirators) are evaluated. If risk estimates remain a concern with maximum PPE, then engineering controls (i.e., encl osed cabs or cockpits, water

soluble packaging, and closed mixing/loading systems) are evaluated. This approach is used to ensure that the lowest level of risk mitigation that provides adequate protection is selected, since the addition of PPE and enginee ring controls involves an additional expense to the user and (in the case of PPE) also involves an additional burden to the user due to decreased comfort and dexterity and increased heat stress and respiratory stress.

Occupational Handler Non

- Cancer Expos ure and Risk Estimate Equations The algorithms used to estimate non

- cancer exposure and dose for occupational handlers can be

found in Appendix A

.

Combining Exposures/Risk Estimates

### Page 18 of 27

The dermal route of exposure does not need to be combined with the assessed inhalation route of

exposure or included in the aggregate risk assessment because there is no identified dermal

hazard.

Summary of Occupational Handler Non

- Cancer Exposure and Risk Estimates The results of the occupational handl er exposure and risk assessment indicate that short

- and

intermediate

- term inhalation risks do not exceed HED’s LOC (i.e. an MOE < 100 ) at baseline mitigation (no PPE)

. Since the short

- and intermediate

- term PODs are the same, the inhalation

MOEs are also the same, ranging from 900 to 10,000,000

. Note that o nly engineering control (enclosed cockpit) data are available to assess risks to handlers operating aircrafts.

The Agency matches quantitative occupational exposure assessment with appropriate

charact erization of exposure potential. While HED presents quantitative risk estimates for human flaggers whe n appropriate, agricultural aviation has changed dramatically over the past

two decades. According the 2012 National Agricultural Aviation Association ( NAAA) survey of their membership, the use of GPS for swath guidance in agricultural aviation has grown steadily from the mid 1990’s. Over the same time period, the use of human flaggers for aerial pesticide applications has decreased steadily from ~15% in the late 1990’s to only 1% in the most recent (2012) NAAA survey. The Agency will continue to monitor all available information sources to best assess and characterize the exposure potential for human flaggers in agricultural aerial applications.

HED has no data to assess exposures to pilots using open cockpits. The only data available is for exposure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the engineering control (enclosed cockpits) and baseline attire (long

- sleeve shirt, long pants, shoes, and socks); per the Agency’s Worker Protection Standard stipulations for engineering controls, pilots are not required to wear protective gloves for the duration of the application. With this level of protection, there are no ris k estimates of concern for applicators.

Table: 6.1.1

. S hort

- and Intermediate

- Term Occupational Risk assessment f or B enzovindifl u pyr

Exposure Scenario Crop or Target a Baseline

Inhalation

Unit Exposure b Maximum

Application

Rate c Area

Treated or

Amount

Handled Daily d Baseline Inhalation

Dose e MOE f

μg/lb ai lb ai/A or

lbai/gal Acres or

gals mg/kg/day LOC = 100

Mixer/Loader Emulsifiable Concentrate

Mixing/Loading Liquids for Aerial Application Orchard Crops 4

0.219 0.046

350 0.000044 190,000

Sod Farms 6 0.067 0.000064 130,000 Typical Field Crops 2 0.089 0.0000853 96,000 Typical Field Crops 1

0.068 350 0.000065 130,000 High

- Acreage Field Crops 3 1200 0.000224 37,000 Mixing/Loading Liquids for Airblast Application Nursery Plants 20 0.0000037 2,200,000

Orchard Crops 4 0.046 40 0.0000050 2,000,000

Mixing/Loading Liquids for Chemigation Orchard Crops 4 0.046

350 0.0000441 190,000 Typical Field Crops 2 0.089 0.0000853 100,000

Sod Farms 6 0.068 0.000065 130,000

### Page 19 of 27

Table: 6.1.1

. S hort

- and Intermediate

- Term Occupational Risk assessment f or B enzovindifl u pyr

Exposure Scenario Crop or Target a Baseline

Inhalation

Unit Exposure b Maximum

Application

Rate c Area

Treated or

Amount

Handled Daily d Baseline Inhalation

Dose e MOE f

μg/lb ai lb ai/A or

lbai/gal Acres or

gals mg/kg/day LOC = 100

Typical Field Crops 1
High

- Acreage Field Crops 3

Greenhouse Plants 5 60 0.0000112 730,000 Nursery Plants 5

Mixing/Loading Liquids for

Groundboom Application Golf Courses 6 (tees and greens only) 0.067 5 0.00000033 3,000,000

Golf Courses 6 (fairways, tees, and greens) 0.067 40 0.0000073 1,000,000

Field

- Grown Ornamentals 5

0.068 40 0.0000075 1,100,000 Nursery Plants 6 60 0.0000112 730,000 Greenhouse Plants 5

Sod Farms 6 0.067

80 0.0000146 560,000 Typical Field Crops 2 0.089 0.0000195 420,000 Typical Field Crops 1 0.068 0.0000149 550,0000 High

- Acreage Field Crops 3 200 0.0000373 220,000

Mixer/Loader Water Dispersible Granular

Mixing/Loading

WDG for Aerial Application Typical Field Crops 2

8.36 0.089 350 0.0035 2,300
Typical Field Crops 1
0.068 350 0.00266 3,100

High

- Acreage Field Crops 3 1200 0.00914 9 00

Mixing/Loading

WDG for Chemigation Typical Field Crops 2 0.089

350 0.0035 2,300 Typical Field Crops 1 0.068 0.00266 3,100 High

- Acreage Field Crops 3

Greenhouse Plants 5 0.067 60 0.00045 18,000 Nursery Plants 5
Mixing/Loading

WDG for Airblast Application Nursery Plants 0.067 20 0.00015 55,000

Mixing/Loading

WDG for

Groundboom Application Typical Field Crops 2 0.089 80 0.0008 1,000 Typical Field Crops 1 0.068 80 0.00061 13,000 High

- Acreage Field Crops 3 200 0.0015 5,400

Greenhouse Plants 5

0.067 60 0.00045 18,000 Nursery Plants 5

Field

- Grown Ornamentals 5
Nursery Plants 6

Greenhouse Plants 5
Applicator

Applying Sprays for Aerial Application Orchard Crops 4

0.0049 0.046

350 0.00000099 8,300,000

Sod Farms 6 0.067 0.00000144 5,700,000 Typical Field Crops 2 0.089 0.00000191 4,300,000 Typical Field Crops 1 0.068 350 0.00000146 5,600,000 High

- Acreage Field Crops 3 1200 0.000005 1,600,000

Applying Sprays for

Groundboom Application Golf Courses 6 (tees and greens only)

0.34 0.067 5 0.00000143 5,700,000

Golf Courses 6 (fairways, tees, and greens) 40 0.0000114 720,000

Field

- Grown Ornamentals 0.068 40 0.0000116 710,000 Nursery Plants 5 0.068 60 0.0000174 470,000 Greenhouse Plants 5

Sod Farms 6 0.067 80 0.0000228 360,000

### Page 20 of 27

Table: 6.1.1

. S hort

- and Intermediate

- Term Occupational Risk assessment f or B enzovindifl u pyr

Exposure Scenario Crop or Target a Baseline

Inhalation

Unit Exposure b Maximum

Application

Rate c Area

Treated or

Amount

Handled Daily d Baseline Inhalation

Dose e MOE f

μg/lb ai lb ai/A or

lbai/gal Acres or

gals mg/kg/day LOC = 100

Typical Field Crops 2 0.089 80 0.0000303 270,000 Typical Field Crops 1 0.068 80 0.000231 350,000 High

- Acreage Field Crops 3 200 0.0000578 140,000
Flagger

Flagging for Aerial Applications Orchard Crops 4

0.35 0.046

350 0.0000705 120,000

Sod Farms 6 0.067 0.000103 80,000 Typical Field Crops 1 0.068 0.000104 79,000 High

- Acreage Field Crops 3

Typical Field Crops 2 0.089 0.000136 60,000

Mixer/Loader/Applicator Emulsifiable Concentrate

M/L/A Liquids for Backpack Sprayers Orchard (Ground/Soil) 4 2.58 0.0046 lb ai/gal)

40

gallons 0.0000059 1,000,000

Greenhouse Plants (Foliar) 5 140

0.00068 lb ai/gal 0.000048 170,000 Nursery Plants (Foliar) 5

Nursery Plants (Ground/Soil) 5 2.58 8.78e

- 7 3,000,000

Landscaping 5 (trees/shrubs/bushes) 140 0.000048 170,000 Landscaping (plants/flowers) 5
Landscaping 6 (turf, lawns, athletic fields, parks, etc) 2.58 0.0023

lb ai/gal 0.00000296 3,000,000

M/L/A Liquids for Manually

Pressurized Handwand Sprayers Greenhouse Plants (Foliar) 5

30 0.00068 lb ai/gal 40

gallons 0.00001 800,000 Nursery Plants (Foliar) 5
Landscaping 5 (trees/shrubs/bushes) Landscaping (plants/flowers) 5

Landscaping 6 (turf, lawns, athletic fields, parks, etc) 30 0.0023 lb ai/gal 0.000035 240,000

M/L/A Liquids for Mechanically

Pressurized Handgun Sprayers Orchard Crops (Foliar) 4 3.9 0.0046 lb ai/gal

1000

gallons 0.000224 37,000 Orchard Crops (Ground/Soil) 4
Greenhouse Plants (Foliar) 5 120

0.00068 lb ai/gal 0.000102 80,000 Greenhouse Plants (Ground/Soil) 5
Nursery Plants (Foliar) 5

3.9 0.0000331 300,000 Nursery Plants (Ground/Soil) 5
Landscaping (trees/shrubs/bushes) 5
Typical Field Crops (Foliar) 1 3.9 0.0068 lb ai/gal 0.000331 25,000 Typical Field Crops 1 (Ground/Soil) Typical Field Crops (Foliar) 2 3.9 0.0089 lb ai/gal 0.000434 19,000 Typical Field Crops 2 1 (Ground/Soil)

Golf Courses (tees and greens only) 6

1.9 0.067 5

acres 0.00000796 1,000,000 Golf Courses (fairways, tees, and

greens) 6 Landscaping (turf, lawns, athletic fields, parks, etc) 6

Mixer/Loader/Applicator Water Dispersible Granular

M/L/A WDG

formulation for Backpack Sprayers Greenhouse Plants (Foliar) 5 140

0.00067 lb ai/gal 40 0.000047 170,000 Nursery Plants (Foliar) 5
Nursery Plants (Ground/Soil) 5 2.58 0.00000086 9

, 5 00,000 Landscaping 5 (trees/shrubs/bushes) 140 0.000047 170,000 Landscaping (plants/flowers) 5

### Page 21 of 27

Table: 6.1.1

. S hort

- and Intermediate

- Term Occupational Risk assessment f or B enzovindifl u pyr

Exposure Scenario Crop or Target a Baseline

Inhalation

Unit Exposure b Maximum

Application

Rate c Area

Treated or

Amount

Handled Daily d Baseline Inhalation

Dose e MOE f

μg/lb ai lb ai/A or

lbai/gal Acres or

gals mg/kg/day LOC = 100

M/L/A WDG

formulation for Manually

Pressurized Handwand Sprayers Greenhouse Plants (Foliar) 5

30 0.00067 lb ai/gal 40

gallons 0.0000101 810,000 Nursery Plants (Foliar) 5
Landscaping 5 (trees/shrubs/bushes)

Landscaping (plants/flowers) 5

M/L/A WDG for Mechanically

Pressurized Handgun Sprayers Greenhouse Plants (Foliar) 5

120 0.00067 lb ai/gal 1000

gallons 0.000101 8,100 Greenhouse Plants (Ground/Soil) 5
Nursery Plants (Foliar) 5
Nursery Plants (Ground/Soil) 5

3.9 1000 gallons 0.000033 250,000 Landscaping (trees/shrubs/bushes) 5
Typical Field Crops (Foliar) 1 0.0068 lb ai/gal 0.00033 25,000 Typical Field Crops 1 (Ground/Soil) Typical Field Crops (Foliar) 2 0.0089

lb ai/gal 0.000434 19,000 Typical Field Crops 2 (Ground/Soil)

a Crop or Target

1 Typical Field Crops at 0.068 lb ai/A or 0.0068 lb ai/gal.

B lueberries, canola, cucurbits, fruiting vegetables, grapes, legumes

, peanuts, tuberous and corm vegetables.

2 Typical Field Crops at 0.089 lb ai/A or 0.0 0 89 lb ai/ga l ( 10 gals/A dilution) Peanuts, s and tuberous and corm vegetables (soil directed)

. 3 High

- Acreage Field Crops at 0.068 lb ai/A or 0.0068 lb ai/gal. Corn, cotton, cereals and, soybeans.

4 Orchard crops Pome fruits at 0.046 lb ai/A or 0.0046 lb ai/gal

. 5 Nursery Plants” include ornamentals, vegetables, trees, container stock , g reenhouse p lants includ ing ornamentals, roses, cut flowers, container

stock and vegetables at 0.068 lb ai/A or 0.00068 lb ai /gal (100 gals /A dilution)

. 6 Turf and sod farms 0.067 lb ai/A or 0.0023 lb ai/gal

b Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2012); Level of mitigation = Bas eline.

c Based on the maximum application rat es on the proposed labels (Reg. Nos 100

- 1 to 100

- 9, See table 4.1 and 4.2)

. d Exposure Science Advisory Council Policy #9.1.

e Inhalation Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) ÷ BW ( 80 kg).

f Short

- term and intermediate

- term Inhalation MOE = Inhalation NOAEL ( 8.2 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).



### 6

. 2 Occupational Post

- application Exposure/Risk Estimates

HED uses the term post

- application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re

entry exposure). Such exposures may occur when workers enter previously treated area s to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post

- application exposure.

Non

- cancer derm al post

- application risks were not assessed because adverse effects were not
seen in the subchronic 28

- day dermal toxicity study up to the Limit Dose (1,000 mg/kg/day).

### Page 22 of 27

6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

There are multiple potential sources of post

- application inhalation exposure to individuals performing post

- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or p articulates that contain pesticides. The agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received th e SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

OPP

- 2014

- 0219 ). During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, ro ute

- specific inhalation toxicological studies) or further analysis is required for b enzovindiflupyr

.

In addition, the Agency is continuing to evaluate the available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force . Given these two efforts, the Agency will continue to identify the need for and, subsequently, the way to incorporate occupational post

- application inhalation exposure into the agency's risk assessments.

Although a quantitative occupational post

- applica tion inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than pos t

- application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post

- application inhalation exposure scenarios

.

Furthermore, inhalation exposure during dusty mechanical activitie s such as shaking and mechanical harvesting is another potential source of post

- application inhalation

exposure. However, the airblast applicator scenario is believed to represent a reasonable worst case surrogate estimate of post

- application inhalation e xposure during these dusty mechanical harvesting activities. The non

- cancer inhalation risk estimate for commercial airblast application is not of concern (i.e., MOE > 100)

.

The Worker Protection Standard for Agricultural Pesticides contains requirements for protecting workers from inhalation exposures during and after greenhouse applications through the use of ventilation requirements.[40 CFR 170.110, (3) (Restrictions associated with pesticide applications)]

.

6.3 Restricted Entry Interval

The REI spec ified on the proposed labels is based on the acute toxicity of b enzovindifl u pyr

. B enzovindifl u pyr is classified as Toxicity Category III via the dermal route and Toxicity Category IV for skin irritation potential. It is not a dermal sensitizer. Occupational non

- cancer

### Page 23 of 27

s hort

- and intermediate

- term post

- application risk estimates were not evaluated for

b enzovindifl u pyr

. Under 40 CFR 156.208 (c) (2) (iii), ai’s classified as Acute III for acute dermal, eye irritation and primary skin irrigation are assigned a 12

- hour REI. Therefore, the [156 subpart K] Worker Protection Statement interim REI of 12 hour s is adequate to protect agricultural workers from post

- application exposures to b enzovindifl u pyr

.

### Page 24 of 27

Appendix A. Summary of Occupational Handler Non

- Cancer Algorithms

Average Daily Dose Potential daily exposures for occupational handlers are calculated using the following formulas:

E=UE * AR * A * 0.001 mg/ug

W here:

E = e xposure (mg ai/day),

UE = u nit e xposure (μg ai/lb ai),

AR = m aximum application rate according to proposed label (lb ai A or lb ai/gal), and

A = a rea treated or amount handled (e.g., A/day, gal/day).

The daily doses are calculated using the following formula:

ADD= E * AF

BW W here:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day),

E = e xposure (mg ai/day),

AF = absorption fa ctor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure

Non

- cancer risk estimates for each application handler scenario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. The daily inhalation dose received by occupational handlers a re compared to the appropriate POD ( i.e.

, NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE

values a re calculated using the followi ng formula:

MOE= POD

ADD W here:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).

### Page 25 of 27

Appendix B . Summary of Residential Handler and Post

- Application Non

- Cancer Algorithms

RESIDENTIAL NON



### - CANCER HANDLER ALGOR ITHMS



### Dermal and Inhalation Handler Exposure Algorithm

– Turf and ornamental Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, for a given

formulation

- application method combination, is estimated by multiplying the formulation

application method

- specific unit exposure by an estimate of the amount of active ingredient handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate (e.g., lb ai/ft 2 

### , lb ai/gal); and A = area treated or amount handled (e.g., ft 2 

### /day, gal/day).

Dermal and/or inhalation absorbed doses normalized to body weight ar e calculated as:

D = E *AF / BW

where:

D = dose (mg/kg

- day); E = exposure (mg/day); AF = absorption factor (dermal and/or inhalation); and BW = body weight (kg).

RESIDENTIAL NON



### - CANCER POST



### - APPLICATION ALGORITH MS



### Post

- A pplication Hand

- to

- Mouth Exposure Algorithm for Physical Activities on Turf Exposure from hand

- to

- mouth activity is calculated as follows (based on the algorithm utilized in

the SHEDS

- Multimedia model ):

E = [HR * ( F

M 

### * SA H 

### ) * (ET * N_Replen) * (1

- (1

- SE ) (Freq_HtM/N

- Replen) 

### )]

where:

E = exposure (mg/day); HR = hand residue loading (mg/cm 2 

### ); FM = fraction hand surface area mouthed / event (fraction/event); SAH = typical surface area of one hand (cm 2 

### ); ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (inter vals/hour); SE = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_HtM = number of hand

- to

- mouth contacts events per hour (events/hour).

### Page 26 of 27

and

where: HR = hand residue loading (mg/cm 2 

### );

Fai hands 

### = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless); DE = dermal exposure (mg); and

SA H 

### = typical surface area of one hand (cm 2 

### ).

Post

- A pplication Object

- to

- Mouth Exposure Algorithm for Physical Activities on Turf Exposure from object

- to

- mouth activity is calculated as follows (based on the algorithm utilized

in SHEDS

- Multimedia): E = [OR* CF1 * SAM O 

### * (ET * N_Replen) * (1

- (1

- SE O 

### ) (Freq_OtM/N_Replen) 

### )]

where: E = exposure (mg/day); OR = chemical residue loading on the object on day “t” (ug/cm 2 

### ); CF1 = weight unit conversion factor (0.001 mg/μg);

SAM O 

### = area of the object surface that is mouthed (cm 2 

### /event); ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour);

SE O 

### = s aliva extraction factor (i.e., mouthing removal efficiency); and Freq_OtM = number of object

- to

- mouth contact events per hour (events/hour).

and

OR = AR * F O 

### * CF2 * CF3

where: OR = chemical residue loading on the object (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F O 

### = fraction of residue available on the object (unitless); CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

Post

- A pplication Incident al Soil Ingestion Exposure Algorithm for Physical Activities on Turf Exposure from incidental soil ingestion is calculated as follows: E = SRt * SIgR * CF1

where: E = exposure (mg/day); SRt = soil residue on day "t" (μg/g); SIgR = ingestion rate of soil (mg/day); and CF1 = weight unit conversion factor (1 x 10

- 6 

### g/μg).

and SRt = AR * FS * (1

- F D 

### ) t 

### * CF2 * CF3 * CF4

where:

SR t 

### = soil residue on day "t" (μg/g);

### Page 27 of 27

AR = application rate (lbs ai/ft 2 

### or lb ai/acre); FS = fraction of ai available in uppermost cm of soil (fraction/cm);

F D 

### = fraction of residue that dissipates daily (unitless); T = post

- application day on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### o r 2.47 x 10

- 8 

### acre/cm 2 

### ); and CF4 = soil volume to weight unit conversion factor (0.67 cm 3 

### /g soil).