UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Date: September 03, 2014 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Benzovindiflupyr: Occupational and Residential Exposure and Risk Assessment 

for the Proposed Uses of the New Fungicide, on Cereals, Blueberries, Com, 

Cotton, Cucurbits, Fruiting vegetables, Small Fruit Vines climbing subgroup 

(except fuzzy kiwifruit), Legume Vegetables, Peanuts, Pome fruit, Rapeseed, 

Tuberous and Corm, Ornamentals Crops and Turf grass. 

PC Code: 122305 

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 

Risk Assessment 

Tadayon, Chemist Branch ~~ ;/ 

Health Effects Division (7509P) 

Office of Pesticide Programs 

DP Barcode: 0421981 

Decision No.: 473382 

Regulatory Action: Section 3 

Case No.: NA 

CAS No.: 1072957-71-1 

40CFR: NA 

ExpoSAC 

ExpoSAC 

Reviewer, 

Reviewer, 

Bridgett 

Kelly Lowe 

Bobowiec ~ 

~ 

~ 

Exposure Science Advisory Committee (Exp5SAC) I HED 

THROUGH: Michael S. Metzger, Branch Chief u /) fJ . Kt-·-

Risk Assessment Branches V and VI {;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 Division (RD) requested that the Health Effects Division (HED) conduct an 

occupational and residential exposure and risk assessment for all of the proposed uses of a 

new fungicide, benzovindiflupyr, including agricultural uses on wheat, triticale, barley, 

rye, 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 vegetables, ornamentals (greenhouses and outdoor nurseries and 

turfgrass (including sod farms)). 

It is HED policy to use the best available data to assess exposure. Several sources of generic 

data were used in this assessment as surrogate data in the absence of chemical-specific data, 

including Pesticide Handlers Exposure Database Version 1.1 (PHED I. I); the Agricultural 

Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force 

(ORETF) dataset) and the Residential SOPs (Lawns!Turt). Some of these data are proprietary, 

and subject to the data protection provisions of the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). 

Note: This memorandum was reviewed by the Exposure Science Advisory Committee 

(ExpoSAC) on 8/21/ 2014. 

Page 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 Residential 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 Dehydrogenase 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. Benzovindiflupyr, 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, turfgrass and

on ornamentals (greenhouses and outdoor nurseries).

Eight formulated end-use products were evaluated in this assessment including emulsifiable 

concentrations (ECs) and water dispersible granules (WDGs).

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 ft2or 0.0068 lb

ai/gallon. The proposed labels require occupational handlers 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 Profile

For the proposed use sites, there is a potential for short-term and intermediate-term occupational 

exposure to benzovindiflupyr during mixing, loading, applying, and other handling tasks; and 

during post-application activities. There is potential for short-term residential exposure during 

handling and post-application activities from the registered uses of benzovindiflupyr on turf, 

parks, golf courses, sod farms, nurseries and ornamental plantings. Chronic exposure is not 

expected for the proposed agricultural uses because of the benzovindiflupyr use-pattern. 

Although benzovindiflupyr 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 

potential for continuous occupational exposure. Additionally, since 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 exposure 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 dose (1,000 

mg/kg/day); therefore, a dermal non-cancer exposure assessment is not required for 

benzovindiflupyr. 
Page 5 of 27

The CARC committee determined based on a weight-of-evidence approach of the overall tumor 

profile that benzovindiflupyr should have a cancer classification 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 high acute toxicity via the 

oral (Toxicity Category II) route of exposure, and moderate toxicity via the dermal (Toxicity 

Category III) and inhalation (Toxicity Category III) 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 benzovindiflupyr 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 benzovindiflupyr on susceptible plants such as flowers, ornamental 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 3,600,000, 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 

benzovindiflupyr application to all purposed uses ranged from 900 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 benzovindiflupyr at this time. If new policies or procedures 

are put into place, the Agency may revisit the need for a quantitative occupational postapplication inhalation exposure assessment for benzovindiflupyr. 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 Agricultural 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/pesticides/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 benzovindiflupyr. 

2.1 Summary of Risk Estimates

Occupational Exposure and Risk Estimates

The results of the occupational handler exposure and risk assessment indicate 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 shortand intermediate-term PODs are the same, the inhalation MOEs are also the same, ranging from 

900 to 10,000,000. Dermal handler and post-application exposure and risk assessments were not 

conducted because a dermal hazard was not identified for benzovindiflupyr.

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 range 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 benzovindiflupyr. Short-term incidental oral post-application risk estimates for all 

scenarios are not of concern to HED (MOEs range from 8,000 to 3,600,000) because they exceed 

the level of concern (LOC) for incidental oral exposure (i.e. an MOE < 100).

2.2 Label Recommendations 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 Deficiencies and Requirements

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

benzovindiflupyr.

The benzovindiflupyr 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% for formulations applied as liquids; the proposed uses 

only apply to liquid formulations of benzovindiflupyr. 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 default 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 potentially 

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 benzovindiflupyr at this time 

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

The benzovindiflupyr 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 postapplication dermal exposure. Because there is no hazard via the dermal route of exposure, a noncancer dermal post-application risk assessment was not performed for benzovindiflupyr. 

Therefore, DFR studies are not needed for benzovindiflupyr 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 benzovindiflupyr is summarized in Table 3.1. 

Table 3.1. Summary of Acute Toxicity Data for Benzovindiflupyr

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

LD50=66.3 mg/kg

(HED calculation)

Note: The LD50 value for hydroxybenzovindiflupyr (SYN546039) is >2000 mg/kg 

(MRID 48604458), putting doubt on this LD50

value for benzovindiflupyr. Animals were fasted 

prior to dosing, which can sensitize them to 

mitochondrial toxins. At the 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)

LD50>2000 mg/kg III

870.1300 Acute Rat Inhalation Toxicity Study 

(Nose-Only) (2010, MRID 48604429)

LC50> 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 1X for all population subgroups and exposure scenarios. 

The toxicological PODs and endpoints for benzovindiflupyr 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 Benzovindiflupyr 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

(females) 

mg/kg/day

UFA= 10x

UFH= 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 ShortTerm (1-30 days) 

and IntermediateTerm (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 

benzovindiflupyr at the Limit Dose (1000 mg/kg/day) to rats for 28 days. 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 benzovindiflupyr 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. UFA = 

extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human 

population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk 

assessment. UFDB = 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 equivalent 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 and/or fetal 

effects.

4.0 Use Profile 

There are numerous end-use product labels purposed with benzovindiflupyr as the active 

ingredient. These include liquid and water dispersible granular formulations. The labeled use 

sites include various agricultural crops, golf courses, nurseries, landscape ornamentals, 

residential/commercial turf, and sod farms. The purposed uses are soil or foliar application, and

are applied either via aerial, airblast, chemigation, groundboom or handheld equipment. The 

maximum application rates for all uses is 0.089 lb ai/A (0.236 lb ai/1000 ft2or 0.0068 lb ai/gal). 

The REI for all the proposed uses is 12 hours. 

Based on the proposed use patterns, it has been determined 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 below. 

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

Table 4.1 Summary of purposed labels for Benzovindiflupyr Products

Product Name/Formulation Registration No Active Ingredient Uses

Benzovindiflupyr Technical 100-1 Benzovindiflupyr Crop, Turf

&ornamental

s

A15457/Emulsifiable Concentrate 100-2 Benzovindiflupyr Crop

A15457LG/Emulsifiable Concentrate 100-3 Benzovindiflupyr Turf

A18126/Water Dispersible Granular 100-4 Benzovindiflupyr + Azoxystrobin Crop

A18126LG/ Water Dispersible Granular 100-5 Benzovindiflupyr + Azoxystrobin Turf

MURALTM/ Water Dispersible Granular 100-6 Benzovindiflupyr + Azoxystrobin Ornamentals

A18993/ Emulsifiable Concentrate 100-7 Benzovindiflupyr + propiconazole Crop

A19334/ Emulsifiable Concentrate 100-8 Benzovindiflupyr+ difenoconazole Crop

ASCERNITYTM/ Water Dispersible Granular 100-9 Benzovindiflupyr+ difenoconazole Turf

Mixture of benzovindiflupyr and current registered uses (same use patterns) of azoxystrobin, 

propiconazole and difenoconazole are purposed to be used on agricultural crops, turf and 

ornamentals.
Page 10 of 27

Table 4.2. Summary of Proposed Directions for Use of Benzovindiflupyr

Crops Maximum Product 

Rate/A/application (fl oz/A)/ 

lb ai/A

Maximum total 

fl oz/A/ 

season/Number 

of application

Pre-Harvest 

Interval 

(PHI) (days)

Minimum Retreatment Interval 

(days)

Emulsifiable Concentrate Formulation 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 0.236/1000ft2

(0.0015lb ai/1000ft2)

or 0.0023 1b ai/gal 

(label recommends 30 

gallons /A dilution)

41.4/4 NA 14-21

Ornamentals 10.5/0.068

or 0.00068 lb ai/gal

(label recommends 100 

gallons /A dilution)

28/3 NA 7-21

Water Dispersible Formulation Products(MURALTM,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 Benzovindiflupyr

Crops Maximum Product 

Rate/A/application (fl oz/A)/ 

lb ai/A

Maximum total 

fl oz/A/ 

season/Number 

of application

Pre-Harvest 

Interval 

(PHI) (days)

Minimum Retreatment 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 benzovindiflupyr

will result in residential handler and post-application exposure in residential settings. The 

benzovindiflupyr 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 in 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 benzovindiflupyr on the susceptible 

plants 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 quantitative 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 exposure scenarios have been assessed:

Residential Handler:

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

ornamentals (0.0023 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 (0.0015 lb 

ai/1000 ft2), 

 Mixing/loading/applying liquids with a backpack sprayer to turf and ornamentals (0.0023

lb ai/gal) 

 Mixing/Loading/applying WDG with a hose-end sprayer 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 (0.0015lb ai/1000 

ft2).

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 20,000,000. 

Table 5.1.1:Residential Handler Non-cancer Exposure and Risk Estimates for Benzovindiflupyr

Exposure Scenario Level of 

Concern

Inhalation 

Unit 

Exposure

(mg/lb ai)

Maximum 

Application 

Rate1

Area

Treated or 

Amount 

Handled 

Daily2

Inhalation

Dose

(mg/kg/day)3 MOE4

Emulsifiable Concentrate(EC)

M/L/A with a Hose-end Sprayer to Turf and 

Ornamentals 100 0.022 0.067 lb ai/A 0.5 acres 0.0000092 890,000

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

and ornamentals 100 0.018 0.0023 lb ai/gal 5 gal 0.0000026 3,200,000

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

ai/ ft2 1000 ft2 0.00000041 20,000,000

M/L/A with a backpack sprayer to Turf and ornamentals 100 0.14 0.0023 lb ai/gal 5gals 0.00002 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 ft2 1000 ft2 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 benzovindiflupyr labels.

2 Exposure Science Advisory Council Policy #9.1.

3

Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) 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-Application 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 3,600,000, and were 

not of concern to HED. 

Table 5.1.2: Residential Post-Application Non-cancer Exposure and Risk Estimates for Benzovindiflupyr

Lifestage Post-application Exposure Scenario Dose1 MOEs2

Child Turf - sprays

Hand to Mouth 0.0010 8,000

Object to Mouth 0.000031 260,000

Incidental Soil Ingestion 0.0000023 3,600,000

1 Hand-to-Mouth = [Hand residue loading (mg/cm2

) x (fraction hand surface area mouthed/event (0.127/event) x typical surface area of one 

hand (150 cm2)) 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 cm2). 

 Object-to-Mouth = ((Object Residue (μg/cm2) x CF1 (1.0E-3 mg/μg) x Object Surface Area Mouthed/Event (10 cm2/event)) x (Exposure 

Time (1.5 hrs/day) x #Replenishment Intervals/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(0.000001))/Body Weight (11 kg).

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

 The inhalation exposure estimate from treating ornamentals with a manually pressurized 

handwand 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 MOE2

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 methods (e.g., groundboom and 

airblast) employed for benzovindiflupyr. 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 Offices 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

(http://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 quantitatively 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 Assessment (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 Federal 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 report 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

benzovindiflupyr.

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 

applications 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 levels 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

agricultural uses. The quantitative exposure/risk assessment developed for occupational handlers 

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

benzovindiflupyr. 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 applications,

 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 chemigation 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 mechanicallypressurized 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 

handler 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 handler 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 occupational 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 exposures”, are outlined in the “Occupational Pesticide Handler Unit 

Exposure Surrogate Reference Table1”, which, along with additional information on HED policy 

on use of surrogate data, including descriptions of the various sources, can be found at the 

Agency website2. 

 

1 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf

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 based on HED Expo 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 application 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, the 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 multiple 

clients within a region).

Mitigation/Personal Protective 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., enclosed cabs or cockpits, watersoluble 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 engineering 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 Exposure 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 handler 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 only engineering control 

(enclosed cockpit) data are available to assess risks to handlers operating aircrafts.

The Agency matches quantitative occupational exposure assessment with appropriate 

characterization of exposure potential. While HED presents quantitative risk estimates for 

human flaggers when 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 risk estimates of concern for applicators.

Table: 6.1.1. Short- and Intermediate-Term Occupational Risk assessment for Benzovindiflupyr

Exposure Scenario Crop or Targeta

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

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 Crops4

0.219

0.046

350

0.000044 190,000

Sod Farms6 0.067 0.000064 130,000

Typical Field Crops2 0.089 0.0000853 96,000

Typical Field Crops1

0.068

350 0.000065 130,000

High-Acreage Field Crops3 1200 0.000224 37,000

Mixing/Loading 

Liquids for Airblast 

Application

Nursery Plants 20 0.0000037 2,200,000

Orchard Crops4 0.046 40 0.0000050 2,000,000

Mixing/Loading 

Liquids for 

Chemigation

Orchard Crops4 0.046

350

0.0000441 190,000

Typical Field Crops2 0.089 0.0000853 100,000

Sod Farms6 0.068 0.000065 130,000
Page 19 of 27

Table: 6.1.1. Short- and Intermediate-Term Occupational Risk assessment for Benzovindiflupyr

Exposure Scenario Crop or Targeta

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A or

lbai/gal

Acres or 

gals mg/kg/day LOC = 100

Typical Field Crops1

High-Acreage Field Crops3

Greenhouse Plants5

60 0.0000112 730,000 Nursery Plants5

Mixing/Loading 

Liquids for 

Groundboom 

Application

Golf Courses6

(tees and greens only) 0.067 5 0.00000033 3,000,000

Golf Courses6

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

Field-Grown Ornamentals5

0.068

40 0.0000075 1,100,000

Nursery Plants6

60 0.0000112 730,000 Greenhouse Plants5

Sod Farms6 0.067

80

0.0000146 560,000

Typical Field Crops2 0.089 0.0000195 420,000

Typical Field Crops1

0.068 0.0000149 550,0000

High-Acreage Field Crops3 200 0.0000373 220,000

Mixer/Loader Water Dispersible Granular

Mixing/Loading 

WDG for Aerial 

Application

Typical Field Crops2

8.36

0.089 350 0.0035 2,300

Typical Field Crops1

0.068

350 0.00266 3,100

High-Acreage Field Crops3 1200 0.00914 900

Mixing/Loading 

WDG for 

Chemigation

Typical Field Crops2 0.089

350

0.0035 2,300

Typical Field Crops1

0.068 0.00266 3,100 High-Acreage Field Crops3

Greenhouse Plants5

0.067 60 0.00045 18,000 Nursery Plants5

Mixing/Loading 

WDG for Airblast 

Application

Nursery Plants 0.067 20 0.00015 55,000

Mixing/Loading 

WDG for 

Groundboom 

Application

Typical Field Crops2 0.089 80 0.0008 1,000

Typical Field Crops1

0.068 80 0.00061 13,000

High-Acreage Field Crops3 200 0.0015 5,400

Greenhouse Plants5

0.067 60 0.00045 18,000

Nursery Plants5

Field-Grown Ornamentals5

Nursery Plants6

Greenhouse Plants5

Applicator

Applying Sprays for 

Aerial Application

Orchard Crops4

0.0049

0.046

350

0.00000099 8,300,000

Sod Farms6 0.067 0.00000144 5,700,000

Typical Field Crops2 0.089 0.00000191 4,300,000

Typical Field Crops1

0.068 350 0.00000146 5,600,000

High-Acreage Field Crops3 1200 0.000005 1,600,000

Applying Sprays for 

Groundboom 

Application

Golf Courses6

(tees and greens only)

0.34

0.067

5 0.00000143 5,700,000

Golf Courses6

(fairways, tees, and greens) 40 0.0000114 720,000

Field-Grown Ornamentals 0.068 40 0.0000116 710,000

Nursery Plants5

0.068 60 0.0000174 470,000 Greenhouse Plants5

Sod Farms6 0.067 80 0.0000228 360,000
Page 20 of 27

Table: 6.1.1. Short- and Intermediate-Term Occupational Risk assessment for Benzovindiflupyr

Exposure Scenario Crop or Targeta

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A or

lbai/gal

Acres or 

gals mg/kg/day LOC = 100

Typical Field Crops2 0.089 80 0.0000303 270,000

Typical Field Crops1

0.068 80 0.000231 350,000

High-Acreage Field Crops3 200 0.0000578 140,000

Flagger

Flagging for Aerial 

Applications

Orchard Crops4

0.35

0.046

350

0.0000705 120,000

Sod Farms6 0.067 0.000103 80,000

Typical Field Crops1

0.068 0.000104 79,000 High-Acreage Field Crops3

Typical Field Crops2 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

Landscaping6

(turf, lawns, athletic fields, parks, etc) 2.58 0.0023lb ai/gal 0.00000296 3,000,000

M/L/A Liquids for 

ManuallyPressurized 

Handwand Sprayers

Greenhouse Plants (Foliar)5

30 0.00068

lb ai/gal 40

gallons

0.00001 800,000 Nursery Plants (Foliar)5

Landscaping5(trees/shrubs/bushes)

Landscaping (plants/flowers)5

Landscaping6

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

M/L/A Liquids for 

MechanicallyPressurized 

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

Nursery Plants (Ground/Soil) 3.9 0.0000331 300,000 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 Crops2 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 9,500,000

Landscaping 5(trees/shrubs/bushes) 140 0.000047 170,000 Landscaping (plants/flowers)5
Page 21 of 27

Table: 6.1.1. Short- and Intermediate-Term Occupational Risk assessment for Benzovindiflupyr

Exposure Scenario Crop or Targeta

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A or

lbai/gal

Acres or 

gals mg/kg/day LOC = 100

M/L/A WDG 

formulation for 

ManuallyPressurized 

Handwand Sprayers

Greenhouse Plants (Foliar)5

30 0.00067

lb ai/gal

40

gallons 0.0000101 810,000

Nursery Plants (Foliar)5

Landscaping5(trees/shrubs/bushes)

Landscaping (plants/flowers)5

M/L/A WDG for 

MechanicallyPressurized 

Handgun Sprayers

Greenhouse Plants (Foliar)5

120 0.00067

lb ai/gal

1000

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

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 Crops2

(Ground/Soil)

a Crop or Target

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

Blueberries, canola, cucurbits, fruiting vegetables, grapes, legumes, peanuts, tuberous and corm vegetables.

2Typical Field Crops at 0.089 lb ai/A or 0.0089 lb ai/ga l( 10 gals/A dilution)

Peanuts, s and tuberous and corm vegetables (soil directed).

3High-Acreage Field Crops at 0.068 lb ai/A or 0.0068 lb ai/gal.

Corn, cotton, cereals and, soybeans.

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

5 Nursery Plants” include ornamentals, vegetables, trees, container stock, greenhouse plants including 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 = Baseline.

c Based on the maximum application rates on the proposed labels (Reg. Nos100-1 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 (80kg).

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 reentry exposure). Such exposures may occur when workers enter previously treated areas 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 dermal 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 particulates 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 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 report and has developed a Volatilization Screening Tool and a subsequent 

Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA-HQOPP-2014-0219). 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 benzovindiflupyr.

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-application 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 post-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 activities 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 exposure 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 specified on the proposed labels is based on the acute toxicity of benzovindiflupyr. 

Benzovindiflupyr 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

short- and intermediate-term post-application risk estimates were not evaluated for

benzovindiflupyr. 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 hours is adequate to protect 

agricultural workers from post-application exposures to benzovindiflupyr. 
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

Where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

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

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

The daily doses are calculated using the following formula:

ADD= 

E * AF

BW

Where:

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

E = exposure (mg ai/day),

AF = absorption factor (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 are compared to the appropriate POD 

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

values are calculated using the following formula:

MOE= 

POD

ADD

Where:

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).
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Appendix B. Summary of Residential Handler and Post-Application Non-Cancer 

Algorithms

RESIDENTIAL NON-CANCER HANDLER ALGORITHMS

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 formulationapplication 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/ft2, lb ai/gal); and

A = area treated or amount handled (e.g., ft2/day, gal/day).

Dermal and/or inhalation absorbed doses normalized to body weight are 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 ALGORITHMS

Post-Application 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 * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)

(Freq_HtM/N-Replen))]

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

FM = fraction hand surface area mouthed / event (fraction/event);

SAH = typical surface area of one hand (cm2);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_HtM = number of hand-to-mouth contacts events per hour (events/hour).
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and

SA * 2

Fai *DE

HR

H

hands



where:

HR = hand residue loading (mg/cm2);

Faihands = fraction ai on hands compared to total surface residue from dermal transfer coefficient 

study (unitless);

DE = dermal exposure (mg); and

SAH = typical surface area of one hand (cm2).

Post-Application 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 * SAMO * (ET * N_Replen) * (1- (1- SEO)

(Freq_OtM/N_Replen))]

where:

E = exposure (mg/day);

OR = chemical residue loading on the object on day “t” (ug/cm2);

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

SAMO = area of the object surface that is mouthed (cm2/event);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SEO = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_OtM = number of object-to-mouth contact events per hour (events/hour).

and

OR = AR * FO * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm2);

AR = application rate (lbs ai/ft2or lb ai/acre);

FO = fraction of residue available on the object (unitless);

CF2 = weight unit conversion factor (4.54 x 108 μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3ft2/cm2or 2.47 x 10-8acre/cm2).

Post-Application Incidental 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 10-6g/μg).

and

SRt = AR * FS * (1-FD)

t

* CF2 * CF3 * CF4

where:

SRt = soil residue on day "t" (μg/g);
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AR = application rate (lbs ai/ft2or lb ai/acre);

FS = fraction of ai available in uppermost cm of soil (fraction/cm);

FD = 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 108 μg/lb);

CF3 = area unit conversion factor (1.08 x 10-3ft2/cm2 or 2.47 x 10-8acre/cm2); and

CF4 = soil volume to weight unit conversion factor (0.67 cm3/g soil).