Page 2 of 13 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, b enzovindiflupyr. Registration is proposed for b enzovindiflupyr use on cereals (wheat, triticale, barley, rye, and oat), blueberries (non

- bearing), corn (fi eld, 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. T he Agency is also proposing to establish tolerances for residues of b enzovind iflupyr 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) pyrazole

carboxamides 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 actio n 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 follo wing 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 benzovin diflupyr (15% a.i.) and azoxystrobin (30% a.i.).

Background

On 11/27/2012 , EPA received a n application from Syngenta Crop Protection for registration of the new fungicide benzovindiflupyr (also known as Solatenol and SYN545192). The application
was als o submitted for simulta n eous review by the P e st Management R egulatory Agency (PMRA) of Canada and the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) of Mexico . The E PA, the PMRA and COFEPRIS combined the i r resources and
cond u cted a "joint revie w " of benzovindiflupyr. Ea c h coun t ry conducted an in i t ial (prima r y) review of particular e l em e nts of the ov e r a ll d a ta package which contained a total of
328 studies.

Each countr y 's team of sc i en t i sts p e e r

- r e v i ew e d the primary reviews of their counterparts to

r ea c h c o nsensus on t h e eval uat i o n of the data. While con t inui n g to consu l t and coordinat e , human health and ecol o g i cal r i s k assessments were developed by each country indi v i dually.

The proposed application methods for b enzovindiflupyr include foliar spray s (ground, aerial, and chemigation)

, soil applications (in

- furrow and banded) and soil drench applications . ProposedPage 3 of 13 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

- 20 13

- 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 evaluat i n g a pe s t icide regi s t ration application, the EPA assesses a wide variety of

exposure i nf o r m a t ion ( i

. e. , where and how t he pesticide is used) and environmen t a l fate (i.e., how the chemic a l will move in the environment) and toxicity studies (i. e

. , e f f ects on humans and other no n

- tar g et orga n i sms) to deter m i ne the likelihood of adverse effects (i. e

. ,

r isk) from exposures associated with the proposed use of the product. Risk assessme n t s are dev e loped to evaluate the environmental f ate of the compound as well as how it might
affect a wide range of non

- targe t organisms i ncluding hum a n s , te rrestrial and aquatic
wildlife (plants and animals). On the basis of these assessments, EPA evaluates and

approves language for each pesticide lab e l to ensure the di re c t ions for use and safety

measures are appropriate to m i t i gate potential risk. In this wa y , the pesticid e ' s label helps

to communicate essential limitations and m i t i g a

t ions that are necessary to ensure the pesticide does not pose unreasonable adverse effects on the environment. I t is a FI F RA
viol a t ion to use a pes t i cide in a way that is inconsistent with the label.

1. Assessment of Risk to Human Health

EPA requires a w i de 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 i s 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.Page 4 of 13 Table 1 . Summary of the T oxi cological D oses and E ndpoints selected for u se in the
H uman H ealth R isk A ssessment for B enzovindiflupyr. 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
UF A = 10x
UF H = 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
UF A = 10x
UF H = 10x FQPA SF= 1x Chronic RfD =
0.082 mg/kg/day

cPAD = 0.082 mg/kg/day 2

- Generation Reproduction Study (rat)
Parental/Off spring 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 decr eased spleen weights in the F1 and/or F2 offspring.
Incidental
Oral
Short

– Term (1

- 30 days) Parental/Offspring
NOAEL = 8.2 mg/kg/day
UF A = 10x
UF H = 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

o f 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.Page 5 of 13 Table 1 . Summary of the T oxi cological D oses and E ndpoints selected for u se in the
H uman H ealth R isk A ssessment for B enzovindiflupyr. 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, t here 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
UF A = 10x
UF H = 10x FQPA SF= 1x Residential LOC
for MOE = 100 2

- Generation Reproduction Study (rat)
Parental/Off spring 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 hep atocellular 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. T he 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. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the hu man population (intraspecies). UF L = use of a LOAEL to extrapolate a
NOAEL. UF S = use of a short

- term study for long

- term risk assessment. UF DB = to account for the absence of key data (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.Page 6 of 13 Table 2

. Summary of Toxicological Doses for Benzovindiflupyr for u se 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

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, neuro, or immunotoxicity.

Inhalation Short (1

- 30 days) and

Intermediate

- term (1

- 6 months) NOAEL: 8.2 mg/kg/day (F)

UF A = 10x

UF H = 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. T he RfD would be protective of non

- carcinog enic 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. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a
NOAEL. UF S = use of a short

- term study for long

- term risk assessment. UF DB = to account for the absence of key data (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.Page 7 of 13 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 b enzovindiflupyr 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.

T here 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 resid ential uses, no dermal hazard was identified in the toxicity database for benzovindif l upyr . Therefore, a quantitative post

application dermal risk assessment was not necessary or completed. Residential dermal exposures are not of risk concern.

In accord ance 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 an d 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 u ses of benzovindif l upyr. 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. Th ere 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 b enzovindifl u pyr

.

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 th at 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 bePage 8 of 13 readily washed off from crops as suggest ed from foliar dissipation half

- liv es 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 quoti ents (RQs) indicate d 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 non

vascular) or terrestrial plants. Avian chronic RQs d id not exceed the LOC in any class scenario.

Acute risks to mammals did not exceed the LOC.

A cute and chronic risk s 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.

R Qs 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 r isks to

e stuarine/ m arine 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 th at 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 f or 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. T herefore, precautio nary 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 b ees) 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 th at further define exposure or through additional toxicity data from Tier II semi

- field or Tier III full

- field studies

conducted with whole colonies.Page 9 of 13 3. Alternatives

The Agency identified several fungicides that may serve as alternatives for the crop sites and pest spectrum on the proposed b enzovindiflupyr product labels. Benzovindiflupyr is expected to be an alternative to certain SDHI fungicides including penthiopyrad, fluopyram, sedaxane, and boscalid. Additional fungicides that benzovindiflupyr may se rve 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 Leafspo t. 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 h as been identified in the field, benzovindiflupyr may serve as an alternati ve 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 benzovindi flupyr 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 contr ol 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 ma nagement 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 effec tive 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 b enzovindifl u pyr 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 b enzovindifl u pyr petitions requesting the establishment of tolerances for a variety of commodities. No comments were received.Page 10 of 13 Data Gaps

There are no outstanding data requirements in accordance with 40 CFR Parts 158 for
b enzovindifl u pyr. 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 su fficient 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 0.2 72 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 inten ds 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

.Page 11 of 13 - 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 v egetative 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,

whea t, canola, pome fruits and turf.

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

a bsen ce 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 scree ning

- 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 feedi ng 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 Agen cy is proposing to requir e 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 non

guideline studies:

a. Acute oral toxicity to larval h oney 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.Page 12 of 13 A schedule for submitting larval and adult honey bee protocols and studies will be determined during the Final Reg ulatory Decision stage.

Due to benzonvindiflupyr’s persistent nature and risks to aquatic organism, t he Agency is also requir ing a study to confirm the environmental fate and surface water

- runoff and the impact of

v egetative 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 reg ulatory decision stage.

In the event that ad verse 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

T he Agency is proposing to conditionally register the new active ingredient benzovindiflupyr

u nder 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), cu curbit 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 veg etable (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 a n environmental protocol
and stud ies 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 ingredi ent 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)
durin g 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 determine d the following:

1) A ll 40 CF R 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

s chedule 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 c oncluded that use of

b enzovindiflupyr will not cause unreasonable adverse effects . Although calculated ecologicalPage 13 of 13 risks are not eliminated for all taxa with the proposed mitigation, they are reduced. Risks to non

listed 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 b enzovindiflupyr to create a barrier between appl ication 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) U se of the pesticide is in the public interest. B enzovindiflupyr is expected t o 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

b enzovindiflupyr 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. Additi onally, 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 (non

bearing), cor n (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 grou p 11

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

.