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Summary

The U.S. Environmental Protection Agency, referred to hereafter as EPA or the Agency, is 

proposing to grant a conditional registration under section 3(c)(7)(C) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) for the new active ingredient, benzovindiflupyr. 

Registration is proposed for benzovindiflupyr use on cereals (wheat, triticale, barley, rye, and 

oat), blueberries (non-bearing), corn (field, pop, and sweet), cottonseed (subgroup 20C), cucurbit 

vegetable (group 9), fruiting vegetables (crop group 8-10), small fruit vines climbing, except 

fuzzy kiwifruit (subgroup 13-07F), legume vegetables (subgroup 6C), peanuts, pome fruit (crop 

group 11-10), rapeseed (subgroup 20A), tuberous and corm vegetable (subgroup 1C), turf grass 

and ornamentals. In addition, tolerances will be established to cover all of the food uses. The 

Agency is also proposing to establish tolerances for residues of benzovindiflupyr in or on these 

crops under the Federal Food, Drug and Cosmetic Act (FFDCA). Tolerances will also be 

established for imported coffee bean and sugarcane.

Benzovindiflupyr belongs to the succinate dehydrogenase inhibitor (SDHI) pyrazolecarboxamides class of fungicides and is effective against a broad range of fungal diseases. Other 

pyrazole-carboxamide fungicides currently registered in the United States include, fluxapyroxad, 

penflufen, penthiopyrad, and sedaxane. Benzovindiflupyr’s mode of action is an inhibitor of the 

succinate dehydrogenase generation mechanism of the citric acid cycle. 

Benzovindiflupyr is formulated as a technical and eight end-use products. The active ingredient 

benzovindiflupyr is a (50:50) racemic mixture. The proposed benzovindiflupyr end use products 

consist of either emulsifiable concentrate or water dispersible granule formulations. 

Emulsifiable concentrate formulations compose of benzovindiflupyr as the single active 

ingredient (10.27% a.i.) or compose of the following co-formulants: 7.5%:11.25% 

benzovindiflupyr: difenoconazole; 2.24%:11.25% benzovindiflupyr: difenoconazole; and 7.24%: 

12.07% benzovindiflupyr: propiconazole. Water dispersible granule formulations compose of 

the multiple active ingredients benzovindiflupyr (15% a.i.) and azoxystrobin (30% a.i.). 

Background

On 11/27/2012, EPA received an application from Syngenta Crop Protection for registration of 

the new fungicide benzovindiflupyr (also known as Solatenol and SYN545192). The application 

was also submitted for simultaneous review by the Pest Management Regulatory Agency

(PMRA) of Canada and the Federal Commission for the Protection against Sanitary Risk

(COFEPRIS) of Mexico. The EPA, the PMRA and COFEPRIS combined their resources and

conducted a "joint review"of benzovindiflupyr. Each country conducted an initial 

(primary) review of particular elements of the overall data package which contained a total of 

328 studies. 

Each country's team of scientists peer-reviewed the primary reviews of their counterparts to

reach consensus on the evaluation of the data. While continuing to consult and coordinate, 

human health and ecological risk assessments were developed by each country individually. 

The proposed application methods for benzovindiflupyr include foliar sprays (ground, aerial, and 

chemigation), soil applications (in-furrow and banded) and soil drench applications. Proposed 
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application rates range from 0.046 to 0.089 lb a.i./A. The maximum seasonal application rate is

0.272 lbs. a.i./A. Application intervals range between 7 and 21 days. 

Tolerances were requested for cereals (wheat, triticale, barley, rye, and oat), corn (field, pop, and 

sweet), cottonseed (subgroup 20C), cucurbit vegetable (group 9), fruiting vegetables (crop group 

8-10), small fruit vines climbing, except fuzzy kiwifruit (subgroup 13-07F), legume vegetables 

(subgroup 6C), peanuts, pome fruit (crop group 11-10), rapeseed (subgroup 20A), tuberous and 

corm vegetable (subgroup 1C), turf grass and ornamentals. The petitioner also requested import 

tolerances for residues of benzovindiflupyr on imported coffee and sugarcane. 

Supporting documentation

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-

0141, is available at http://www.regulations.gov. For a listing of the supporting assessments and 

reference documents please refer to the Docket Posting Memorandum. 

Chemical Evaluation

In evaluating a pesticide registration application, the EPA assesses a wide variety of

exposure information (i .e., where and how the pesticide is used) and environmental fate

(i.e., how the chemical will move in the environment) and toxicity studies (i.e., effects on

humans and other non-target organisms) to determine the likelihood of adverse effects (i.e.,

risk) from exposures associated with the proposed use of the product. Risk assessments are

deve loped to evaluate the environmental fate of the compound as well as how it might

affect a wide range of non-target organisms including humans, terrestrial and aquatic

wildlife (plants and animals). On the basis of these assessments, EPA evaluates and

approves language for each pesticide label to ensure the directions for use and safety

measures are appropriate to mitigate potential risk. In this way, the pesticide's label helps

to communicate essential limitations and mitigations that are necessary to ensure the 

pesticide does not pose unreasonable adverse effects on the environment. It is a FIFRA

violation to use a pesticide in a way that is inconsistent with the label.

1. Assessment of Risk to Human Health

EPA requires a wide range of studies in order to assess a pesticide. For benzovindiflupyr, the 

database of studies required to support the assessment of risk to human health is complete. 

Benzovindiflupyr has low acute toxicity by the dermal and inhalation routes, with moderate 

toxicity via the oral route. It is not a dermal sensitizer, but causes mild skin irritation and 

moderate eye irritation. Tables 1 and 2 summarize the toxicological doses and endpoints selected 

for use in the human health risk assessment for benzovindiflupyr.
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Table 1. Summary of the Toxicological Doses and Endpoints selected for use in the 

Human Health Risk Assessment for Benzovindiflupyr.

Exposure/ 

Scenario

Point of Departure

and Uncertainty/

Safety Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute 

Dietary

(All 

Populations, 

including 

Infants and 

Children)

NOAEL=10 

mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF= 1x

Acute RfD = 0.10 

mg/kg/day

aPAD =0.10 

mg/kg/day

Acute neurotoxicity screening 

battery (rat) 

NOAEL=10 mg/kg/day. LOAEL = 

30 mg/kg/day based on multiple 

clinical observations, decreases in 

mean body temperature, decreases 

in locomotor activity parameters, 

reduced food consumption and/or 

decreases in mean grip strength.

Chronic 

Dietary 

(All 

Populations)

Parental/Offspring 

NOAEL = 8.2 

(females) mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF= 1x

Chronic RfD = 

0.082

mg/kg/day

cPAD = 0.082 

mg/kg/day

2-Generation Reproduction Study 

(rat) 

Parental/Offspring NOAEL = 8.2 

mg/kg/day (F)

LOAEL = 19.4 mg/kg/day (F) 

based on decreased body weight 

and decreased food consumption 

in parental animals as well as 

increases in liver weights, 

centrilobular hepatocellular 

hypertrophy, increased incidence 

of cell hypertrophy in the pars 

distalis of the pituitary, reduced 

body weight, delayed preputial 

separation, and decreased spleen 

weights in the F1 and/or F2 

offspring.

Incidental 

Oral 

Short –Term 

(1-30 days)

Parental/Offspring 

NOAEL = 8.2 

mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF= 1x

Residential LOC 

for MOE = 100

Two-Generation Reproduction 

Toxicity Study (rat)

Parental/Offspring NOAEL = 8.2 

mg/kg/day (F)

LOAEL = 19.4 mg/kg/day (F)

based on decreased body weight 

and decreased food consumption 

in parental animals as well as 

increases in liver weights, 

centrilobular hepatocellular 

hypertrophy, increased incidence 

of cell hypertrophy in the pars 

distalis of the pituitary, reduced 

body weight, delayed preputial

separation, and decreased spleen weights 

in the F1 and/or F2 offspring.
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Table 1. Summary of the Toxicological Doses and Endpoints selected for use in the 

Human Health Risk Assessment for Benzovindiflupyr.

Exposure/ 

Scenario

Point of Departure

and Uncertainty/

Safety Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

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 benzovindiflupyr at the Limit Dose 

(1000 mg/kg/day) to rats for 28 days. Additionally, there are no concerns for 

developmental, reproductive, neurotoxicity, or immunotoxicity.

Inhalation 

Short-term 

(1-30 days) 

and 

Intermediate

-Term (1-6 

months)

Parental/Offspring 

NOAEL: 8.2 

mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF= 1x

Residential LOC 

for MOE = 100

2-Generation Reproduction Study 

(rat) 

Parental/Offspring NOAEL = 8.2 

mg/kg/day (F)

LOAEL = 19.4 mg/kg/day (F)

based on decreased body weight 

and decreased food consumption 

in parental animals as well as 

increases in liver weights, 

centrilobular hepatocellular 

hypertrophy, increased incidence 

of cell hypertrophy in the pars 

distalis of the pituitary, reduced 

body weight, delayed preputial 

separation, and decreased spleen 

weights in the F1 and/or F2 

offspring.

Cancer 

(oral, 

dermal, 

inhalation)

Classification: “Suggestive Evidence of Carcinogenic Potential” Quantification 

of carcinogenicity is not required. The RfD would be protective of noncarcinogenic and carcinogenic effects observed in the rat carcinogenicity study 

or mode of action studies conducted at higher doses. 

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). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
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Table 2. Summary of Toxicological Doses for Benzovindiflupyr for use in Occupational 

Human Health Risk Assessments.

Exposure/ 

Scenario

Point of Departure

and Uncertainty 

Factors

Level of 

Concern for 

Risk Assessment

Study and Toxicological 

Effects

Dermal

Short-Term (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.

Inhalation Short 

(1-30 days) and 

Intermediate-term 

(1-6 months)

NOAEL: 8.2 

mg/kg/day (F)

UFA= 10x

UFH= 10x

Occupational 

LOC for MOE = 

100

2-Generation Reproduction 

Study (rat) 

Parental/Offspring 

NOAEL = 8.2 mg/kg/day 

(F). LOAEL = 19.4 

mg/kg/day (F) based on 

decreased body weight and 

decreased food 

consumption in parental 

animals as well as increases 

in liver weights, 

centrilobular hepatocellular 

hypertrophy, increased 

incidence of cell 

hypertrophy in the pars 

distalis of the pituitary, 

reduced body weight, 

delayed preputial 

separation, and decreased 

spleen weights in the F1 

and/or F2 offspring.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Suggestive Evidence of Carcinogenic Potential”

Quantification of carcinogenicity is not required. The RfD would be 

protective of non-carcinogenic and carcinogenic effects observed in the 

rat carcinogenicity study or mode of action studies conducted at higher 

doses. 

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). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
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EPA has not made a common mechanism of toxicity finding as to benzovindiflupyr and other 

carboxamide class pesticides. 

Acute and chronic dietary (food and drinking water combined) risk estimates for the proposed 

uses of benzovindiflupyr did not exceed the Agency’s level of concern (LOC) for the general 

U.S. population or any population subgroup, including infants and children. The acute and 

chronic dietary exposure assessments were conservative in utilizing unrefined analyses with

tolerance level residues, 100% crop treated, and default processing factors. 

There is the potential for residential exposures from the proposed uses of benzovindiflupyr on 

turf and ornamentals. Adult and children exposure estimates are not of risk concern. While there 

is the potential for post-application dermal exposures from residential uses, no dermal hazard 

was identified in the toxicity database for benzovindiflupyr. Therefore, a quantitative postapplication dermal risk assessment was not necessary or completed. Residential dermal 

exposures are not of risk concern. 

In accordance with FQPA, the Agency considered aggregate pesticide exposures and risks from 

food, drinking water, and residential exposures. Based on the proposed uses of benzovindiflupyr, 

combined (or aggregate) exposures can occur from dietary sources (food and water) and during 

or following use in residential settings. There are no aggregate risk estimates of concern for 

adults or children exposed to benzovindiflupyr as a result of the proposed uses.

Occupational exposures are anticipated from the proposed uses of benzovindiflupyr. All 

occupational exposure scenarios assessed using baseline clothing and default non-chemical 

specific assumptions resulted in estimated short- and intermediate-term inhalation margin of 

exposure (MOE) well above the LOC (100) and are therefore not of concern. While there is the 

potential for post-application exposure to workers, no dermal hazard was identified. Therefore, a 

quantitative occupational post-application dermal risk assessment is not required and was not 

completed. There are no risk concerns for dermal exposures.

The Worker Protection Statement interim Restricted Entry Interval (REI) of 12 hours is adequate 

to protect agricultural workers from post-application exposures to benzovindiflupyr. 

No data deficiencies were identified with respect to the human health evaluation.

2. Assessment of Ecological Risk

Benzovindiflupyr is very persistent in terrestrial and aquatic environments. Benzovindiflupyr’s

low solubility and mobility indicate that it may leach in small quantities. Benzovindiflupyr is not 

expected to escape from dry or moist soil surfaces or water bodies to the atmosphere via 

volatilization given its low vapor pressure. Benzovindiflupyr that is applied to crops and soil 

may be transported to surface water via erosion of benzovindiflupyr-ladened soil particles 

concurrent with rain events after application. Benzovindiflupyr residues are expected to be 
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readily washed off from crops as suggested from foliar dissipation half-lives ranging between 0.6 

– 20 days. 

When estimates of benzovindiflupyr exposure considering all proposed uses in terrestrial and 

aquatic environments are compared to the available ecotoxicity data, the resulting risk quotients 

(RQs) indicated a potential for risk to most, but not all aquatic and terrestrial taxa. Risks above 

the level of concern (LOC) were not identified for aquatic plants (both vascular and nonvascular) or terrestrial plants. Avian chronic RQs did not exceed the LOC in any class scenario. 

Acute risks to mammals did not exceed the LOC. 

Acute and chronic risks were identified for freshwater fish and estuarine/marine fish with RQs 

ranging 0.1 to 2.4; where the LOC=0.5 (acute) and 0.4 to 10.8; where the LOC=1 (chronic). For 

terrestrial organisms, acute dose-based risk to birds was identified in all size classes of birds. 

RQs for acute exposures to birds ranged from 0.1 - 4.6; LOC= 1.0). There was also chronic 

dose-based risk identified in all size classes of mammals with RQs ranging from 0.03-2.3; 

LOC=1.0. 

In an effort to reduce the RQ exceedances, several label mitigations were proposed by the 

applicant (eg., reduced application rates, reduced number of applications, longer re-treatment 

intervals, and prohibition of aerial application for some crops). As a result, chronic risks to 

estuarine/marine organisms were resolved for all proposed crop uses. However, risks with acute 

freshwater fish (RQ = 0.18 – 1.49) and chronic freshwater fish (RQ = 0.7 – 5.3) remained. 

Chronic risks to mammals where reduced to RQs ranging between 0.01 and 1.1. Acute avian

risks were reduced to RQ ranging between <0.1 – 2.9. Details of the mitigation and resulting 

RQs are detailed in the addendum to Section 3 Environmental Fate and Ecological Assessment. 

The Agency has recently issued interim guidance for assessing the potential risks of pesticides to 

bees and the data needed to support such assessments (USEPA et al., 2014). The guidance 

document indicates that if exposure of bees to a pesticide is expected, a Tier I risk assessment is 

conducted. The Tier I assessment is intended to be sufficiently conservative that chemicals that 

result in no LOC exceedances are considered to represent a relatively low risk for potential 

adverse effects to bees. 

The available data (acute oral and contact toxicity studies both for adult bees) suggest that 

benzovindiflupyr is practically non-toxic to bees and preliminary exposure modeling and RQ 

analysis suggests that risk to adult bees via the contact and oral exposure pathways is below the 

level of concern. Therefore, precautionary label language for bees is not necessary at this time. 

However, in order for the Agency to complete a Tier 1 risk assessment for honey bees that is 

consistent with the interim assessment methods, the following laboratory-based studies (of 

individual bees) are needed: acute oral toxicity to larval honey bee, chronic oral toxicity to larval 

honey bees and chronic oral study for adult honey bees. If risk concerns are identified in the 

screening-level assessment, the assessment may be refined using data that further define 

exposure or through additional toxicity data from Tier II semi-field or Tier III full-field studies 

conducted with whole colonies. 
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3. Alternatives

The Agency identified several fungicides that may serve as alternatives for the crop sites and pest 

spectrum on the proposed benzovindiflupyr product labels. Benzovindiflupyr is expected to be 

an alternative to certain SDHI fungicides including penthiopyrad, fluopyram, sedaxane, and 

boscalid. Additional fungicides that benzovindiflupyr may serve as an alternative to include 

captan and mancozeb. 

4. Benefits

Benzovindiflupyr is intended to prevent or treat a wide variety of fungal plant diseases. Efficacy 

has been reported for the premix formulations against a broad range of fungal diseases to include 

Gummy Stem Blight, Powdery Mildew, Apple Scab, and Leafspot. Efficacy is also achieved 

with benzovindiflupyr as a solo formulation in rotations with alternatives for a variety of crop 

pathogens. Under conditions where SDHI-resistance has been identified in the field, 

benzovindiflupyr may serve as an alternative to manage pathogens resistance. 

Benefits will also be recognized for benzovindiflupyr application on minor crops (e.g., cucurbits, 

fruiting vegetables, pome fruits) where there are limited registered alternatives. It is not 

anticipated that benzovindiflupyr would enhance yield and/or quality as compared to currently 

registered fungicides in situations where SDHI-resistance has not developed.

Benzovindiflupyr is currently registered in Brazil and other countries in Latin America where it 

provides control of Asian soybean rust. Registration in the U.S. would provide an additional 

control option for growers in the southern part of the U.S. Registration is also in the public’s 

interest for use of benzovindiflupyr on a host of minor crops. 

Resistance management is an important consideration of pesticide stewardship. As such, 

benzovindiflupyr will be sold primarily in premixes or co-packs with other modes of action. To 

reduce the likelihood of resistance development with use of benzovindiflupyr, each of the end 

use formulation labels contain resistance management language inclusive of the Mode of Action 

and the FRAC pesticide code(s). Resistance management recommendations include the 

limitation of no more than two sequential applications and use of effective chemical alternatives 

in rotation programs. Utilization of integrated pest management programs is also encouraged on 

the proposed labeling. 

Public Comments

On 3/30/15, EPA published a Notice of Receipt in the Federal Register of an application for 

registration of benzovindiflupyr and announced a public comment period of 30 days. No 

comments were received.

On 6/5/13, EPA published a Notice of Filing in the Federal Register announcing the receipt of 

the initial filing of the benzovindiflupyr petitions requesting the establishment of tolerances for a 

variety of commodities. No comments were received. 
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Data Gaps

There are no outstanding data requirements in accordance with 40 CFR Parts 158 for 

benzovindiflupyr. However, the Agency is requiring pollinator effects toxicity data to conduct a 

screening level risk assessment to confirm that benzovindiflupyr is not toxic to bees. Although 

several studies were classified as supplemental, the collective data base was sufficient to assess 

benzovindiflupyr. The Agency has determined that the data submitted per 40 CFR Part 158 are 

acceptable. The Agency is not requiring the submission of additional data for those guidelines 

classified as supplemental under 40 CFR Part 158. A listing of the supplemental studies are 

provided in table 3. 

Table 3. Summary of Environmental Studies Classified as Supplemental.

Guideline Number Study MRIDs

835.2240 Aqueous Photolysis 48604507

835.2410 Soil Photolysis 48604495

835.4300 Aerobic Aquatic Metabolism 48604509, 48604510

835.4400 Anaerobic Aquatic Metabolism 48604509, 48604510

835.6100 Terrestrial Field Dissipation -Soil Column 48604502, 48604581

835.6100

Terrestrial Field Dissipation -Foliar 

Dissipation 48604502, 48604581

850.1730 Fish Bioconcentration Factor 48604521

850.6100 ECM/ILV - soil

48604412, 48604413,

48604457

850.2100 Avian Acute Oral Toxicity 48604513

850.2200 Acute Dietary Toxicity 49383802

850.4225 Seedling Emergence, Tier II 48604538

Labeling Requirements

In order to address risks and labeling clarifications that were identified in the human health and 

ecological risk assessments, the following labeling changes will be required to minimize the 

potential for exposure to benzovindiflupyr residues and/or or reduce exposure to humans and the 

environment.

- The labels must reflect that following application of benzovindiflupyr to primary crops up to 

a seasonal rate of 0.272 lb. ai/A (300 g ai/ha) plant-back intervals of 180 days or longer are to 

be observed for rotated crops. 

- The labels must specify that the use on greenhouse grown tomatoes is not permitted; 

additional residue data would be required if the registrant intends to support a greenhouse 

tomato use. 

- Labels must specify that use on blueberries is restricted to “lowbush” blueberries since these 

are the only variety that have a non-cropping year of production.

- The maximum application rate must be reduced to 0.046 lb ai/A for canola, cereals, corn and 

soybeans and 0.056 lb ai/A for legumes.
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- The labels must reflect a reduced number of applications per year. One application per year 

is allowed for lowbush blueberries, 2 applications per year for corn, and 3 applications per 

year for peanuts.

- Retreatment intervals on labels must be lengthened for pome fruit, soybeans, tuberous and 

potato, corn, sweet corn, cotton, fruiting vegetables, grapes and peanuts. 

- Foliar applications must be removed as an application method for potatoes. The labels must 

prohibit foliar application for potatoes.

- Aerial applications must be removed as an application method for sweet corn, cucurbits, 

fruiting vegetables, cotton and grapes. The labels must prohibit aerial application for these 

crops.

- A vegetative buffer strip for all crops must be added to the end-use product labels in addition 

to aerial spray drift buffers for corn (other than sweet), ornamentals, peanuts, soybeans, 

wheat, canola, pome fruits and turf.

- Application to residential landscapes must be limited to professional applicators only. In 

absence of this prohibition, end-use products would require restricted use classification due 

to acute toxicity concerns for eye irritation. 

Conditional Data Requirements:

The Agency has issued guidance for assessing the potential risks of pesticides to bees and the 

data needed to support such assessments (USEPA et al., 2014). The guidance document indicates 

that if exposure of bees to a pesticide is expected, a Tier I screening-level risk assessment is 

conducted. In addition to the honey bee adult contact toxicity study identified in the 40 CFR part 

158, additional studies are recommended to support a Tier I screening-level risk assessment. 

These studies include: acute oral toxicity to adult honey bees, acute oral toxicity to larval honey 

bees, and chronic oral toxicity to adult honey bees. 

The available data (acute oral and contact toxicity studies for adult bees) suggest that 

benzovindiflupyr is practically non-toxic to bees and preliminary exposure modeling and RQ 

analysis suggests that risk to adult bees via the contact and oral exposure pathways is below the 

level of concern. However, data to address acute and chronic toxicity studies for larval bees and 

chronic feeding studies for adult bees were not submitted. Therefore, risks to terrestrial 

invertebrates is presumed in the absence of data and given benzonvindiflupyr’s potential 

bioavailability to beneficial insects which may be attracted to treated plants. The Agency is 

proposing to require this data to further refine the Agency’s predictions that there is low risk to 

bees. As a condition of the registration, the applicant would need to submit the following nonguideline studies: 

a. Acute oral toxicity to larval honey bee.

b. Chronic oral toxicity to larval honey bees.

c. Chronic oral study for adult honey bees. 

d. Protocols for both of the chronic studies prior to initiating the studies.
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A schedule for submitting larval and adult honey bee protocols and studies will be determined 

during the Final Regulatory Decision stage. 

Due to benzonvindiflupyr’s persistent nature and risks to aquatic organism, the Agency is also

requiring a study to confirm the environmental fate and surface water-runoff and the impact of 

vegetative buffer strips on potential concentrations in water bodies. A protocol must be 

submitted within 120 days of the registration. A schedule for submitting the study will be 

determined during the final regulatory decision stage. 

In the event that adverse effects are detected, the Agency may reassess whether this product 

poses unreasonable adverse effects on the environment. If the Agency finds unreasonable 

adverse effects, the Agency will proceed with appropriate regulatory action which may include 

cancelling the registration. Additionally, as required under FIFRA Section 6(a)(2), the registrant 

is required to report information concerning unreasonable adverse effects.

Proposed Regulatory Decision

The Agency is proposing to conditionally register the new active ingredient benzovindiflupyr 

under Section 3(c)(7)(C) of FIFRA, on the following food and non-food crops: cereals (wheat, 

triticale, barley, rye, and oat), blueberries (non-bearing), corn (field, pop, and sweet), cottonseed 

(subgroup 20C), cucurbit vegetable (group 9), fruiting vegetables (crop group 8-10), small fruit 

vines climbing, except fuzzy kiwifruit (subgroup 13-07F), legume vegetables (subgroup 6C), 

peanuts, pome fruit (crop group 11-10), rapeseed (subgroup 20A), tuberous and corm vegetable 

(subgroup 1C), turf grass and ornamentals. In addition tolerances without U.S. registrations for 

residues on imported coffee and sugarcane will be established. 

Registration for benzovindiflupyr is contingent on the submission of an environmental protocol 

and studies to address target benzovindiflupyr accumulation in water bodies and buffer strip 

efficacy and bee data listed above.

Under Section 3(c)(7)(C) of FIFRA, the Agency may conditionally register a pesticide 

containing a new active ingredient 1) for a period reasonably sufficient for the generation and 

submission of required data (which are lacking because a period reasonably sufficient for 

generation of the data has not elapsed since the Agency first imposed the data requirement); 2) 

during the period of the conditional registration, use of the pesticide will not cause unreasonable 

adverse effects; and 3) use of the pesticide is in the public interest.

In the case of benzovindiflupyr, the Agency has determined the following: 

1) All 40 CFR Part 158 data requirements have been satisfied for the new active 

ingredient benzovindiflupyr. Nevertheless, the Agency has determined that additional data are 

necessary and should the registration be granted would require they be submitted based on a 

schedule to be determined at that time. Therefore there would not be sufficient time for the data 

to have been generated and submitted by the applicant prior to the requirement being imposed. 

2) Consistent with the decision standards in FIFRA, EPA has concluded that use of 

benzovindiflupyr will not cause unreasonable adverse effects. Although calculated ecological 
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risks are not eliminated for all taxa with the proposed mitigation, they are reduced. Risks to nonlisted species are reduced as a result of lowered application rates, increased application intervals, 

and a reduction to the total number of applications for certain uses. Vegetative buffers and spray 

drift buffers will be required for use of the benzovindiflupyr to create a barrier between 

application sites and bodies of water. Once the Agency receives and reviews the environmental 

monitoring information, adjustments may be made to the labeling, as appropriate. 

3) Use of the pesticide is in the public interest. Benzovindiflupyr is expected to play an 

integral role in the disease and resistance management programs. Registration is also beneficial 

given the proposed use on a host of minor crops. Additionally, it is expected that 

benzovindiflupyr would provide a higher efficacious activity compared to other SDHI 

fungicides, where resistance has developed. 

The Agency believes, in accordance with Section 3(c)(7)(C) of FIFRA, that benzovindiflupyr 

will not cause unreasonable adverse effects. Additionally, registration of benzovindiflupyr is in 

the public interest. Therefore, the Agency is proposing to register the new active ingredient 

benzovindiflupyr for use on or in cereals (wheat, triticale, barley, rye, and oat), blueberries (nonbearing), corn (field, pop, and sweet), cottonseed (subgroup 20C), cucurbit vegetable (group 9), 

fruiting vegetables (crop group 8-10), small fruit vines climbing, except fuzzy kiwifruit 

(subgroup 13-07F), legume vegetables (subgroup 6C), peanuts, pome fruit (crop group 11-10), 

rapeseed (subgroup 20A), tuberous and corm vegetable (subgroup 1C), turf grass and 

ornamentals.