Page **2** of **19**

**1.0 Executive Summary**  Fluxapy roxad (1 H

- Py razole
- 4 - carboxamide, 3 - (difluoromethyl)
- 1 - methyl
- N - (3, 4, 5

– trifluoro[1,1
- biphenyl]
- 2 - yl ) belongs to the succunate
- dehydrogenase (SDH) inhibitor class of f ungicides . Furthermore, f luxapy roxad is a broad based fungicide that provides preventive seed and seedling protection f

rom several seed and soil borne diseases. Fluxapyroxad is being reviewed as part of a joint review plan . Partners in the global review include BASF Corporation , Australia (APVMA), Canada (PMRA) and New Zealand
. This document assesses the occupational exposure and risk for all the newly proposed uses of fluxa py roxad . All other active ingredients are assessed in separate memoranda. Proposed U se Profile The proposed use of the fungicide fluxapy roxad (BAS 700F ) is for seed and foliar applications on cereal grains, sorghum, legume vegetables (succulent and dry), oil seed crops (canola and sunflower), peanuts, pome fruit, stone fruit, root and tuber vegetables (potatoes and sugar beets), fruiting vegetables, and cotton. Fluxapy roxad (BAS 700 F) is formulated in an emulsifiable concentrate (BAS 700 01F) and in five suspension concentrate formulations ( BAS 700 02, BAS 700 03, BAS 700 04F, BAS 703 01F, and BAS 703 02F). Applications may be performed by using groundboom, airblast , aerial , and standard slurry or mist
- ty

pe seed treatment equipment. There is a potential for short
- and intermediate
- term occupational exposure to f luxapy roxad during mixing, loading, application, seed treatment (sewing, bagging, and multiple activities), planting activities and post
- application activities, however chronic exposure is not expected for the proposed use patterns
. Label Recommendations Pome fruit may

be harvested on the day

of application (0
- day

PHI), while edible
- podded legume vegetables h ave a (7
- day

PHI), however all other crops (see table 3a) assessed in this document have a (21
- day

PHI). The restricted
- entry interval (REI) is 12 hours. The personal protective equipment (PPE) for this assessment is long
- sleeved shirt and long pants plu s shoes and socks. The labels submitted to HED prohibit greenhouse and transplant applications as well as on farm seed treatment. Hazard Concerns A NOAEL of 9.0 mg/kg/day was selected for the short
- term inhalation exposure point of departure . This NOAEL w as based on a 28 day dietary study in rats , where changes in thyroid hormone levels and thyro id follicular hy pertrophy /hy perplasia were observed
. A NOAEL of 7.3 mg/kg/day

was selected for the interm ediate
- term inhalation point of departure . This NOAEL was based on a 90 day

dietary study in rats , where changes in thyroid hormone levels and thyroid follicular hypertrophy/hy perplasia were noted as well. 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 (i.e. no inhalation absorption factor). A 28 - day dermal toxicity

in rats was conducted and no effects were observed ( LOAEL = Not observed). Therefore, the quantification of short
- and intermediate
- term dermal risk is not required since no hazard was identified. The occupational level of concern (LOC) for the margin of exposure (MOE) is < 100,Page **3** of **19**

based on the standard uncertainty factors for intra
- species variation (10X) and inter
- species extrapolation (10X). Fluxapy roxad has low acute oral, dermal, and inhalation toxicity, regist ering toxicity categories of (III, III, and IV ) , respectively
. Fluxapy roxad is not irritating to the eyes, only slightl y irritating to the skin, and n ot a dermal sensitizer. Fluxapy roxad is classified as “not likely” to be carcinogenic; therefore a quantitative cancer assessment was not conducted. Occupational Handlers Occupational handler exposure is expected for individuals involved in commercial seed treatm ent (primary

handlers), and planting of treated seeds (secondary handlers) as well as mixer loaders, applicators and flaggers for foliar applications via aerial, airblast, and groundboom
. The inhalation risk estimates do not exceed HED’s L OC , and therefore , are not of concern to HED. Occupational Post
- Application

– Foliar Applications The potential for short
- and intermediate
- term exposure to fluxapy roxad during o ccupational post - application activities is likely ; h owever dermal and inhalation risk exposures were not assessed in this memorandum. Occupational Post
- Application

– Seed Treatments The potential for short
- and intermediate
- term occupational exposure to fluxapy roxad during post - application activities is unlikely because s u stained levels of contact with treated seed is not expected after the seed has been placed in the soil or other planting media. Therefore, no quantitative post
- application assessment is required for exposure to treated seeds that have already been planted
. Residential Exposure Residential exposures and risk are not assessed in this document because the proposed uses of fluxapy roxad do not involve applications by residential handlers or commercial applicators in residential settings at this time and there are no existing or proposed residential uses. Review of Human Research This risk assessment relies in part on data from studies in which adult human subjects were intentionally

expo sed to a pesticide or other chemical. These studies, which comprise the Pesticide Handlers Exposure Database (PHED), and the Agricultural Handler Exposure Task Force (AHETF), have been determined to require a review of their ethical conduct, have received that review, and have been determined to be ethical.Page **4** of **19**

**2.0 Hazard Profile**  There is a potential for short
- and intermediate
- term occupational exposure to fluxapy roxad during mixing, loading, application, seed tre atment activities ( sewer, bagger, multiple activities, and planters) , and post
- application activities. Chronic exposure is not expected for the proposed use patterns associated with fluxapy roxad
. Occupational Dermal Exposure (Short
- and Intermediate
- Term) A 28 - day dermal toxicity study in rats (MRID 47923571) was conducted and no effects were observed ( LOAEL = Not observed). Therefore, the quantification of short
- and intermediate
term dermal risk is not required since no hazard was identified. Occupational Inhalation Exposure (Short - and Intermediate
- Term) A NOAEL of 9.0 mg/kg/day was selected for the short
- term inhalation exposure point of departure. This NOAEL was based on a 28 day dietary study in rats (MRID 47923564), where changes in thyroid hormone levels and thyroid follicul ar hy pertrophy /hy perplasia were observed. A NOAEL of 7.3 mg/kg/day was selected for the interm ediate
- term inhalation exposure point of departure . This NOAEL was based on a 90 day dietary study in rats (MRID 47923567), where changes in thyroid hormone levels and thyroid follicular hypertrophy/hy perplasia were noted as well. 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 (i.e. no inhalation absorption factor)
. The occupati onal L OC for an MOE = 100 is based on the standard uncertainty factors for intra
- species variation (10X) and inter
- species extrapolation (10X). An FQPA safety factor of 1X was assigne d. F luxapy roxad is characterized as “not likel y to be carcinogenic to humans”; therefore, cancer risk was not assessed. The acute toxicity and endpoint selections for fluxapy roxad are summarized in Tables 1 and 2, respectivel y. **Table 1. Acute Toxi**  **city Profile for F**  **luxapyroxad** GDLN Study T ype MRID Results Tox Category 870.1100 Ac ute Oral [rat] 47593558 LD 50 >2,000 mg/kg III 870.1200 Ac ute Dermal [rat] 47593559 LD5 50 >2,000 mg/kg III 870.1300 Ac ute Inhalation [rat] 47593560 LC5 50 >5.1 mg/L/ 4 hr IV 870.2400 Ac ute Eye Irritation

[White New

Zealand rabbit] 47593562 Not irritating IV 870.2500 Ac ute dermal Irritation [rabbit] 47593561 Slight dermal irritant IV 870.2600 Dermal Sensitization [Guinea Pig] 47593562 Not a sensitizer IVPage **5** of **19**

**P oint**  **of Departure**  **(POD** ) = A data point or a n 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 me mbers of the human population (intra
- species). **FQPA** SF = FQPA Safety Factor. **RfD** = reference dose. **MOE** = margin of exposure. **LOC** = level of concern. **N/A** = not applicable. **3.0 Use Profile**  Fluxapy roxad belongs to the succunate
- dehydrogenase (SDH) inhibitor class of fungicides. Fluxapy roxad is a fungicide that provides preventive seed and seedling protection from several seed and soil borne diseases. The proposed use of the fungicide fluxapy roxad (BAS 700F) is for seed and foliar applications on cereal grains, legume vegetables (succulent and d ry), oil seed crops (canola and sunflower), peanuts, pome fruit, stone fruit, root and tuber vegetables (potatoes and sugar beets), fruiting vegetables, and cotton. **Table 2. Summary of Toxicological Doses and Endpoints for Fluxapyroxad** Exposure/ Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of

Concern for Risk Assessment Study and

Toxicological Effects Dermal Short
- Term (1
- 30 days) Intermediate
- Term (1
- 6 months NOAEL= 1000 mg/kg/day NA NA 28 - day dermal toxicity in rats (MRID 47923571) LOAEL = No hazard identifie d and therefore quantification is not required

Inhalation Short
- Term (1
- 30 days) NOAEL= 9 mg/kg/day UF A= 10 x

UF H=10 x FQPA SF= 1 x Occupational MOE = 100 mg/kg/day 28 day dietary study in rats (MRID 47923564) LOAEL = 176 mg/kg/day based on thyroid follicular hypertrophy/hyperplasia and clinical chemistry changes.

Inhalation Intermediate
Term (1
- 6 months) NOAEL= 7.3

mg/kg/day UF A= 10 x

UF H=10 x FQPA SF= 1 x Occupational MOE = 100 mg/kg/day 90 day dietary study in rats (MRID 47923567) LOAEL = 276 mg/kg/day based on thyroid follicular hypertrophy/hyperplasia and clinical chemistry changes. Cancer (oral, dermal, inhalation) **Classification:** Not likely to be carcinogenic to humansPage **6** of **19**

Fluxapy roxad (BAS 700 F) is formulated in an emulsifiable concentrate (BAS 700 01F) and in five liquid formulations (BAS 700 02, BAS 700 03, BAS 700 04F, BAS 703 01F, and BAS 703 02F). Applications may

be performed by

using groundboom, airblast, aerial, and standard slurry or mist
- ty pe seed treatment equipment. A summary

of the proposed use profile is presented in Table s 3 a and 3b
. **Table 3 a**  **. Summary of Directions for Use of Fluxapyroxad.**  Product [EPA File Reg. No.] Form

ulation ty pe Crops Application Method Max. Application.

Rate s (lb ai/A) Max.

Application Rate/Season (lb ai/A) EPA: 7969 - GRN EPA: 7969 - GRR EPA: 7969 - GNA EPA: 7969 - GNO EPA: 7969 - GRE (Technical) Em

ulsifiable Concentrate Dried shelled peas, beans,

edible
-podded legume vegetables, fruiting vegetables, oilseed crops (flax, rape, and sunflower seed), pome fruits, stone fruits, sugar beet, tuberous and c orn vegetables (incl. p otatoes), cereal grains, peanut, sorghum, cotton, soy bean Aerial

(fixed wing) Groundboom Air Blast Chemigation Range from

0. 9

– 0.18 (4.5 oz – 11 oz.) Depending on crop 0 .35

(22 oz.)

**Table 3b. Summary of Directi**  **ons for Use of Fluxapyroxad on S eed.**  Product [EPA File Reg. No.] Seed Crop Application Equipment Maximum Application Rates (lb ai/lb seed)

EPA: 7969 - GNI Beans and Peas

(CG6 and CG7) Commercial

Seed Treatment Facility Standard Slurry or Mist
Ty pe Application Equipment Range from

0.0001 - 0.0005 lb ai/lb seed (2.36 oz./100 lbs of seed) Depending on crop seed Soy bean Sunflower and safflower Cereal Grains (CG 15 and 16) Sorghum Cotton PeanutPage **7** of **19**

**4.0 Residential (Non**  **- Occupational) Exposure/Risk Characterization**  There are no residential uses proposed for fluxapy roxad in this registration action, therefore a residential exposure assessment was not conducted. Residential By stander Post - Application Inhalation Exposure Based on the Agency's current practices, a quantitative post
- application inhalation exposure assessment was not performed for fluxapy roxad at this time. However, volatilization of pesticides may

be a potential source of post
- application inhalation exposure to individuals nearby to pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesti cides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory

Panel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ) and is in the process of evaluating the SAP report. The Agency may , as appropriate, develop policies and procedures to identify the need for and, subsequently , the way to incorporate post
a pplication inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative post
- application inhalation exposure assessment for fluxapy roxad
. Spray Drift Spray drift is alway s a potential source of exposure to residents nearby to spraying operations. This is particularly

the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from the ground application method emplo yedfor fluxapy roxad
. The Agency

has been working with the Spray Drift Task Force, 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 w ebsite for more information at http://www.epa.gov/opp00001/factsheets/spraydrift.htm). On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Ag ency has completed its evaluation of the new database submitted by

the Spray

Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy

on how to appropriatel y apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied b y air, orchard airblast and ground hydraulic methods. After the policy

is in place, the Agency

may impose further refinements in spray drift management practices to reduce off
- target drift with specific products with significant risks associated with drift. Although a quantitative residential post
- application inhalation exposure assessment was not performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation exposure assessment was perform ed for flaggers. This exposure scenario is representative of a worse case inhalation (drift) exposure and may be considered protective of most outdoor agricultural and commercial post
- application inhalation exposure scenarios
.Page **8** of **19**

**5.0 Occupational Exposur** **e /**  **Risk Characterization** There is a potential for short
- and intermediate
- term occupational exposure to fluxapy roxad during mixing, loading, application, seed treatment activities (sewer, bagger, multiple activities, and planters), and post
- application activities. Chronic exposure is not expected for the proposed use patterns associated with fluxapy roxad
. **5.1 Occupational Handler**  **(Foliar application)** The anticipated use patterns and current labeling indicate several occupational scenarios based on ty pes of equipment and techniques that can potentially be used for fluxapy

roxad applications. For the purpose of this exposure/risk assessment, the occupati onal handler scenarios are short
and intermediate
- term in duration and are as follows: Mixer/L oader 1. Open mixing/loading for aerial application; 2. Open mixing/loading for groundboom application; 3. Open mixing/loading for airblast application ; Applicator 1. Applying spray s via aerial applications; 2. Applying spray s via groundboom applications ; 3. Applying spray s via airblast applications; 4. Applying spray s via chemigation (covered b y the aerial application mixer/loaders (same rate and area treated) * Flagger The Agency

has evaluated scenarios that may be limited in nature such as flagging during aerial applications because engineering controls (i.e. Global Positioning Satellite technology) are now predominantly

used as indicated by

the 1998 National Agricultural Aviation Association (NAAA) survey

of their membership. It appears, however flaggers are still used in approximately

10 to 15 percent of aerial application operations. In cases like these, the Agency strongl y encourages the use of the engineering control sy stem, but will continue to evaluate risks for flaggers and any other population where a clear exposure pathway exists until the potential for exposure is eliminated. The Agency is aware that NAAA is conducting another survey of its membership on exposure issues and will consider those results as is timely and appropriate. For pesticide handlers, HED presents estimates of dermal exposure for “baseline” (i.e. workers wearing a single layer of work clothing consisting of a long sleeved shirt, long pants, sh oes, plus socks and no protective gloves, as well as for “baseline” and the use of protective gloves or other personal protective equipment (PPE), as might be necessary
. The fluxapy roxad product labels for foliar treatments recommend applicators and other handlers to wear long
- sleeved shirt and long pants, and shoes plus socks.Page **9** of **19**

**5.2 Occupational Handler**  **(Seed Treatment)** Occupational seed treatment handlers may experience short
- and intermediate
- term exposure to fluxapy roxad while performing seed treatment activities in commercial settings. In addition, occupational secondary

handlers may

experience short
- and intermediate
- term exposure while planting fluxapy

roxad
- treated seeds. No chemical
- specific handler exposure data were submitted in support of this use pattern. For assessing commercial seed treatment and seed planting activities, unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed Treatment and MRID 47054702. The amount of active ingredient handle d depends on the application rate (lb ai/lb seed) and the pounds of seed treated in a day (or the pounds of seed that can be planted in a day), all of which vary depending upon the seed type. Values for the amount of seed treated and planted per day were obtained from HED ExpoSAC Policy 15. The results are presented in Table 5 . Treating Seed (Primary

Handler) Potential occupational exposure scenarios from the use of fluxapy roxad as a commercial seed treatment include:  Mixing, loading, appl ying liquid fo rmulations;  Bagging treated seed;  Sewing bags; and  Multiple activities. Ty pically , for large
- scale commercial seed treatments, workers perform only those specific individual tasks listed above; however, it is assumed that workers also may perform multiple activities throughout the day . As a result a “multiple activities” scen ario (i.e. where one worker performs all seed treatment tasks such as loading/applying, sewing, bagging, cleaning, calibration, repair, forklift driver, etc.) was addressed. Planting Treated Seed (Secondary Handler) Potential occupational exposure scenarios from the use of fluxzpy roxad as a commercial seed treatment include planting treated seed (secondary handler). Planting treated seed consists of the farmer purchasing bags of treated seed, placing the seed in the hopper and applying seed to fields (considered a secondary handler exposure scenario). The fluxapy

roxad product labels for seed treatment recommend applicators and other handlers to wear long
- sleeved shirt and long pants, and shoes plus socks. **5.3 Exposu**  **re Data, Factors and Assumptions** 1. Application Rates The proposed tr eatment range is 0.09

– 0.18 lb ai/ acre for aerial, groundboom, and airblastPage **10** of **19**

exposure scenarios, depending on the specific crop. The proposed seed treatment maximum application rate ranges from 0.01
- 0.05 lb ai/ 100 lb seed (2.36 oz/100 lbs seed .) , depending on the specific crop. The maximum application rates (episodic and yearl y) are shown in Table 3 a and 3b . The maximum single application rates were used in the ris k assessment. 2. Body Weight The average adult weight of 8 0 kg wa s used for estimating inhalation exposure
. 3. Exposure Duration It is anticipated that o ccupational fluxapy roxad exposures will generally occur in short
- (1
- 30 day s) and intermediate
- (1
- 6 months) term durations. Based on use data and label instructions, HED believes that occupational exposures may occur over a single day

or up to weeks at a time for many use - patterns and that intermittent exposure over several weeks may also occur. Some applicators may

appl y these products over a period of weeks, because they are commercial applicators who are completing multiple applications for multiple clients. Long
- term expos ures are not expected, therefore, a long
- term assessment was not conducted. 4. Inhalation Absorption Factor Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the o ral route of exposure. 5. Handler Exposure Data Foliar Applications : No chemical
- specific inhalation handler exposure data were submitted in support of this registration. To assess handler exposures for regulatory actions when chemical
specific monitoring data are not available, HED relies on the most scientifically
- reliable surrogate data currentl y available from various sources such as the Pesticide Handlers Exposure Data base (PHED), and the Agricultural Handler Exposure Task Force (AHETF). Some of this data, such as the industry task force data, is compensatory, subject to the data protection provisions of FIFRA. HED policies on use of surrogate data, including their sources, are presented in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (http://www.epa.gov/pesticides/science/handler
- exposure - table.pdf ) and (http://www.epa.gov/pesticides/science/handler
- exposure - data.html)
. Seed Treatment: No chemical
- specific handler exposure data were submitted in support of this use pattern. For assessing commercial seed treatment and seed planting activities, unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed Treatment and MRID 47054702. 6. Area Treated and Amount Handled Foliar applications: The daily areas treated were defined for each handler scenario b y determining the amount that can be reasonable treated in a single day . When possible, the assumptions for daily

areas treated are taken from HED’s ExpoSAC Policy #9 “Standard ValuesPage **11** of **19**

for Dail y Acres Treated in Agriculture”, which was revised on July 5, 2000. Values used for area treated in each scenario included 350 and 120 0 acres for applications with fixed
- wing aircraft (crop specific), 350 acres for flagging, 80 and 200 acres for groundboom applications (crop specifi c), and 20 acres for airblast applications. Seed Treatment : The amount of active ingredient handled depends on the application rate (lb ai/lb seed) and the pounds of seed treated in a day (or the pounds of seed that can be planted in a day), all of which vary

depending upon the seed ty pe. Values for the amount of seed treated and planted per day

were obtained from HED ExpoSAC Policy 15. Amount of Seed Treated per Day (Primary Handler) :
 Beans and Peas (CG6 and CG7)

– 194, 000  Soy bean
- 718, 000  Sunflower and safflower
- 718, 000  Cereal Grains (CG 15 and 16) o Barley

– 718,000 lbs, o Oat

– 718,000 lbs o Triticale

– 718,000 lbs, o Rye - 718,000 lbs, o Wheat

– 718,000 lbs,  Corn (field, sweet, pop)

– 550, 000  Sorghum
- 718, 000  Cotton

– 160, 000  Peanut

– (Loader/Applicat or = 120,000 ), (Sewer, Bagger, and Multiple activities = 718,000 ) Amount of Seed Treated per Day (Secondary

Handler) :
 Beans and Peas (CG6 and CG7)

– 194, 000 lbs,  Soy bean
- 20 , 000 lbs,  Sunflower and safflower

– 7,700 lbs,  Cereal Grains (CG 15 and 16) o Barley

– 19,000 lbs, o Oat - 26,000 lbs o Triticale

– 20,000 lbs, o Rye - 24,000 lbs, o Wheat

– 30,000 lbs,  Corn (field, sweet, pop)

– 3 , 000 lbs,  Sorghum

– 8 00 lbs,  Cotton

– 3,600 lbs,  Peanut

– 11,000 lbs,Page **12** of **19**

Handler Exposure Calculations Handler risks were calculated using the Margin of Exposure (MOE) which is a ratio of the calculated daily

dose to the NOAEL of concern. Daily dose values are calculated using relevant application parameters (i.e., rate and area treated) along with unit exposures. Exposures are then adjusted for body weight and absorption factors as appropriate to calculate dose levels. Daily Exposure : The daily

exposures were calculated as described below.

 **Daily exposure = (Unit exposure x application rate x Daily Area Treated)** Where: Daily

Exposure = Amount (mg ai/day) amount inhaled that is available for

inhalation absorption; Unit Exposure = Unit exposures (mg ai/lb ai) derived from June 2011 Surrogate Table; Application Rate = lbs ai per acre; Daily Area Treated = acres per day Daily Dose: The dail y dose (inhalation) was calculated b y adjusting the daily inhalation exposure values b y body wei ght and accounting for inhalation absorption. For adult handlers using fluxapy

ro xad, an average body weight of 8 0 kg was used.

 **Daily Dose = (Daily exposure x absorption factor)/ Body weight** Where: Daily

Dose = Absorbed dose (mg ai/kg body weight/day); Daily Exposure = Amount (mg ai/day) inhaled; Absorption Factor = 100% for inhalation Body Weight = 8 0 kg Margins of Exposure **:** The daily doses were then compared to the NOAELs to assess the risk as an MOE. The MOEs were calculated using the formula below:

 **MOE = NOAEL/Dose** Where: MOE **=** Margin of Exposure (unit less) Dose **=** mg/kg/day NOAEL **=** No Observed Adverse Effects Level (mg/kg/day)Page **13** of **19**

Occupational Handler Exposure Summary Foliar applications: The short
- and intermediate
- term occupational handler inhalation exposure s for all mixer/loaders, applicators, and flaggers are summarized in Table 4. For occupational handler exposure scenarios, the inhalation risk estimates do not exceed HED’s LOC (MOEs ≥ 100) at baseline exposure and, therefore, are not of concern to HED. HED has no data to assess exposures to pilots using open cockp its. The only data available are for exposure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the engineering control (enclosed cockpits) and baseline attire (lo ng - sleeve shirt, long pants, shoes, and socks); pilots are not required to wear protective gloves. Primary/Secondary Handler (Seed Treatment) The short
- , and intermediate
- term occupational handler exposure s summary for all seed treatment exposure scenarios is summarized in Table 5
. For occupational seed treatment (primary /secondary) exposure scenarios, the inhalation risk estimates do not exceed HED’s LOC ( MOEs ≥ 100) at baseline exposure and, theref ore, are not of concern to HED. Furthermore, an inhalation study

is not required at this time. HED is currently in the process of revising ExpoSAC Policy 15 in efforts to update the dail y amount of seed treated in commercial seed treatment facilities. With the increasing demand for hy bridized treated se eds, there have been modifications not only in the seed treatment equipment, but in the market shares of new and currentl y registered pesticide products. HED understands that d

ue to the high cost of producing hy brid seeds, direct seeding is done in a prec ision manner which requires lower volumes of seed per acre. However, this does not provide a direct correlation to the amount of seed which is treated in the commercial seed treatment facilities. Over the past several years, HED has received submissions f rom Industry

for the use of several seed treatment pesticides which provide a range of daily amounts of vegetable seeds treated (1,000 to 5,500 lbs).Page 14 of 19 **Table 4: Short and Intermediate -**  **Term Risk Assessment For Agricultural Uses of Fluxapyroxad**
**Exposure Scenario**  **Inhalation**

**Unit Exposure**  **(μg/lb ai) 1**  **Crops Application**  **Rate (lb ai/A)**  **2 Area** 

**Treated (A/day)**  **3 MOE**  **4**

**Short -**  **Term Intermediate** 

**- term**  **Inhalation Mixer/Loader** 

Aerial Fixed Wing (enclosed cockpit) 0.219 Fruiting vegetables, oilseed crops (flax, rape, and sunflower seed), pome fruits, stone fruits, sugar beet, tuberous and corn vegetables (incl. Potatoes),oat, peanut, rye, triticale 0. 09 350 100 ,000 85 ,000

Dried shelled beans 0. 18 52 ,000 42 ,000 corn, soybean, wheat 0. 09 1200 30 ,000 25 ,000

Groundboom (open Cab) 0.219 Dried shelled beans 0. 18
80 23 0,000 19 0,000 Fruiting vegetables, oilseed crops (flax, rape, and sunflower seed), pome fruits, stone fruits, sugar beet, tuberous and corn vegetables (incl. Potatoes),oat, peanut, rye, triticale 0.09 46 0,000 37 0,000
corn, soybean, wheat 200 18 0,000 15 0,000 Airblast (open cab) stone fruits 0.11 4 0 7 50 ,000 61 0 ,000 **Applicator**

Aerial Fixed Wing (enclosed cockpit) 0.068 Fruiting vegetables, oilseed crops (flax, rape, and sunflower seed), pome fruits, stone fruits, sugar beet, tuberous and corn vegetables (incl. Potatoes),oat, peanut, rye, triticale 0. 09 350 34 0,000 27 0,000

Dried shelled beans 0.18 17 0 ,000 14 0 ,000 corn, soybean, wheat 0. 09 1200 98 ,000 8 0 ,000Page 15 of 19

**Exposure Scenario**  **Inhalation**

**Unit Exposure**  **(μg/lb ai) 1**  **Crops Application**  **Rate (lb ai/A)**  **2 Area** 

**Treated (A/day)**  **3 MOE**  **4**

**Short**   ** Term** **6 Intermediate** 

**- term**  **Inhalation Applicator** 

Groundboom (open Cab) Chemigation 7 0.068 Dried shelled beans 0.18
80 15 0,000 12 0,000 Fruiting vegetables, oilseed crops (flax, rape, and sunflower seed), pome fruits , sugar beet, tuberous and corn vegetables (incl. Potatoes),oat, peanut, rye, triticale 0.09 29 0,000 24 0,000
corn, soybean, wheat 200 12 0,000 95 ,000 Airblast (open cab) S tone fruits 0.11 4 0 36 ,000 29 ,000 **Flagging** Aerial Fixed Wing (enclosed cockpit) 0.35 corn, soybean, wheat 5 0. 18 35 0 33 ,000 26 ,000
1 Inhalation unit exposure values represent no respirator. 2 Application rates are based on maximum values found in proposed labels 3 Daily area treated is based on the area that can be reasonably applied in a single day for e ach exp osure scenario of concern based on the application method and formulation/packaging type. (standard EPA/OPP/HED values). 5 Corn, Soybeans, and Wheat have the most conservative MOEs, therefore representative for Flagging activities. 6 Short
- /Intermediate
- Term MOE = Inhalation NOAEL ( 9.0 mg/kg/day or 7.3 mg/kg/day ) / Daily Inhalation Dose). The LOC is 100. 7 Chemigation : Aerial applicator MOEs are protective. * Daily Dose (mg/kg/day) was calculated by Unit Exposure * 100 % Inhalation a bsorption factor * A

ppl ication rate * Area treated} / 7 0 kg. **Table 5**  **. Summary of**  **Short -**  **and Intermediate -**  **Term Handler Exposures and Risks for Fluxapyroxad**  **(Seed Treatment Only).**  **Seed Type Inhal** 

**UE** a **Max App**

**Rate**b **Am t** 

**Treated** c **Inhal ation** 

**Dose** d **Short -**  **Term**

**Inhal ation**  **MOE** e **Intermediate -**  **Term**

**Inhal ation**  **MOE** f mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100

**LOADER/APPLICATOR (no respirator)** Peanuts 0.00034 0.000 1 120,0 00 0. 0 00 05 1 18 0 ,000 14 0 ,000 Dried Shelled Beans 0.00034 0.0001 194,000 0.00 0 0 82 110 ,000 89 ,000 Soy bean 0.00034 0.000 1 718,000 0.000 3 1 29 ,0 00 24 ,0 00Page 16 of 19 **Table 5**  **. Summary of**  **Short -**  **and Intermediate -**  **Term Handler Exposures and Risks for Fluxapyroxad**  **(Seed Treatment Only).**  **Seed Type Inhal** 

**UE** a **Max App**

**Rate**b **Am t** 

**Treated** c **Inhal ation** 

**Dose** d **Short -**  **Term**

**Inhal ation**  **MOE** e **Intermediate -**  **Term**

**Inhal ation**  **MOE** f mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100 Cereal Grains 0.00034 0.000 5 718,000 0.00 15 0 5,9 00 4 , 8 00 Corn 0.00034 0.000 5 550,000 0.00 1 2 0 7 ,700 6 , 2 00 Cotton 0.00034 0.000 2 160,000 0.000 1 4 66 ,000 54 ,00 0 Sunflower and safflower 0.00034 0.000 2 718,000 0.000 6 1 15 ,0 00 12 ,0 00 Sorghum 0.00034 0.000 2 718,000 0.000 61 15 ,000 12 ,0 00 **SEWER (no respirator)** Peanuts 0.00023 0.000 1 718,000 0.00 02 1 44 ,0 00 35 ,0 00 Dried Shelled Beans 0.00023 0.00 0 1 194,000 0.0 00 0 6 16 0 ,000 13 0 , 000 Soy bean 0.00023 0.00 0 1 718,000 0.0 0 02 1 44 ,0 00 35 , 0 00 Cereal Grains 0.00023 0.000 5 718,000 0.0 0100 8,7 00 7,1 00 Corn 0.00023 0.0005 550,000 0.000 79 11 ,000 9,2 00 Cotton 0.00023 0.000 2 160,000 0.000 92 98 ,000 7 9 ,000 Sunflower and safflower 0.00023 0.000 2 718,000 0.00 04 1 22 ,0 00 18 ,0 00 Sorghum 0.00023 0.000 2 718,000 0.00 04 1 22 ,0 00 18 ,0 00 **BAGGER (no respirator)** Peanuts 0.00016 0.0001 718,000 0.00014 63 ,000 51 ,0 00 Dried shelled Beans 0.00016 0.0001 194,000 0.00004 23 0,000 19 0 ,000 Soy bean 0.00016 0.0001 718,000 0.00014 63 ,000 51 ,0 00 Cereal Grains 0.00016 0.0005 718,000 0.0007 2 13 ,000 10,000 Corn 0.00016 0.0005 550,000 0.00055 16 ,000 13 ,000 Cotton 0.00016 0.0002 160,000 0.000 0 6 14 0 ,000 11 0 ,000 Sunflower and safflower 0.00016 0.0002 718,000 0.000 29 31 ,0 00 25 ,0 00 Sorghum 0.00016 0.0002 718,000 0.000 29 31 ,000 25 ,0 00 **MULTIPLE ACTIVITIES (no respirator)** Peanuts 0.0016 0.0001 718,000 0.00 1 4 0 6,3 00 5,1 0 0 Dried Shelled Beans 0.0016 0.0001 194,000 0.00 0 39 23 ,0 00 19 ,0 00Page 17 of 19 **Table 5**  **. Summary of**  **Short -**  **and Intermediate -**  **Term Handler Exposures and Risks for Fluxapyroxad**  **(Seed Treatment Only).**  **Seed Type Inhal** 

**UE** a **Max App**

**Rate**b **Am t** 

**Treated** c **Inhal ation** 

**Dose** d **Short -**  **Term**

**Inhal ation**  **MOE** e **Intermediate -**  **Term**

**Inhal ation**  **MOE** f mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100 Soy bean 0.0016 0.0001 718,000 0.0014 0 6,3 00 5,1 0 0 Cereal Grains 0.0016 0.0005 718,000 0.007 2 0 1,3 00 1,200 Corn 0.0016 0.0005 550,000 0.00550 1,6 00 1,3 00 Cotton 0.0016 0.0002 160,000 0.00 0 64 14 ,0 00 11, 000 Sunflower and safflower 0.0016 0.0002 718,000 0.00 290 3,1 00 2,5 0 0 Sorghum 0.0016 0.0002 718,000 0.00 290 3,1 00 2,5 00 **PLANTERS (no respirator)** Peanuts 0.0034 0.0001 11,000 0.0000 47 190 ,000 21 0 , 000 Dried Shelled Beans 0.0034 0.0001 8,000 0.00003 4 26 0,000 190,000 Soy bean 0.0034 0.0001 20,000 0.0000 85 110 ,000 86 ,000 Cereal Grains 0.0034 0.0005 26,000 0.0001 1 8 1 ,000 66 , 000 Corn 0.0034 0.0005 3,000 0.0000 64 14 0,000 11 0 , 000 Cotton 0.0034 0.0002 3,600 0.00003 1 29 0,000 24 0 , 000 Sunflower and safflower 0.0034 0.0002 800 0.0000 68 1 ,300 ,000 1 ,10 0,000 Sorghum 0.0034 0.0002 800 0.0000 68 1,30 0,000 1 ,10 0,000 a Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment. b Application Rates based on propo sed label uses for fluxapyroxad
. c HED default for lb seed planted per day from HED Exposure Science Advisory Council Policy 15, d Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ lb ai) x application rate (lb ai/lb seed) x amount planted (lb seed/day) x absorption factor (100%) / body weight (70 kg adult). e Short
- term Inhalation MOE = NOAEL (9.0 mg/kg/day for short
- term exposure ) / Inhalation Dose (mg/kg/day). Level of concern = 100. f Intermediate
- term Inhalation MOE = NOAEL (7.3 mg/kg/day for intermediate
- term exposure ) / Inhalation Dose (mg/kg/day). Level of concern = 100. * In the case where there are several crops under the crop group assessed, the crop with the highest amount of seeds planted per day was assessed to cover that crop group (i.e., beans and p eas, cereal grains) **6.0 Occupational Post**  **- application Exposure and Risk**  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 a re - entry exposure). Such exposure may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pest or harvesting.Page 18 of 19

Inhalation: Based on the Agency's current practices, a quantitative occupational post
- application inhalation exposure assessment was not performed for fluxapy roxad at this time; an inhalation exposure assessment was performed for occupational handlers. **This assessmen t resulted in**  **risk estimates that did not exceed HED’s level of concern at baseline inhalation PPE.** 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. However, there are multiple potential sources of post
- application inhalation exposure to individuals perform ing post
- application activities in previously treated fields. These potential sources include volatilization of pesticides and re
- suspension 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. The Agency received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/12010 9meeting.html ). The Agency is in the process of evaluating the SAP report as well as available post
- application inhalation exposure data generated by the Agricultural Reentry Task Force and may , as appropriate, develop policies and procedures, to identify the need for and, subsequently , the way to incorporate occupational post
- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment for fluxapy roxad
. Dermal : A quantitative post
- application dermal exposure assessment was not performed since no hazard was identified via the dermal route for fluxapy roxad. Dermal: The potential for post
- application dermal exposures following the planting of fluxapy roxad
- treated seeds is unlikely because s ustained levels of contact with treated seed after it has been placed in the soil or other planting media would not be expected be cause no routine cultural practice required for the production of agricultural commodities involves such an activity as defined in the no/low contact criteria in the Worker Protection Standard (WPS). Therefore, no quantitative post
- application assessment is required for exposure to treated seeds that have already been planted. Inhalation: Post - application inhalation exposure assessment is not required as exposure is expected to be negligible. Seed treatment assessments provide quantitative inhalation exp osure assessments for seed treaters and secondary handlers (i.e. planters). It is expected that these exposure estimates would be protective of most post
- application inhalation exposure scenarios. **7.0 Conclusion**  For foliar applications and seed treatment using fluxapy roxad, occupational handler and post application exposure scenarios did not result in risk estimates o f concern. MOEs were ≥100 and therefore, risk estimates did not exceed the Level of Concerns (LOC) at the max imum proposed application rat es. Furthermore, an inhalation study is not required at this time and fluxapy roxad is classified as “Not likely to be Carcinogenic to Humans”; therefore, a cancer assessment was not conducted in this registration action.Page 19 of 19

**8 .0**  **References**

 Label Use Patterns; (EPA File Registration No. 7969
- GRE, 7967 - GNA, 7969 - GNT, 7969 - GNI, 7969 - GNO, 7969 - GRN, 7969 - GRR)

 Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (http://www.epa.gov/pesticides/science/handler
- exposure - table.pdf ) and (http://www.epa.gov/pesticide s/science/handler
- exposure - data.html)
.  Pesticides Handlers Exposure Database (PHED)Version 1.1; dated 8/98 , AHETF, (HED Science A dvisory

Council for Exposure Draft Policy #7; dated 1/28/99

 End Point Selection; [(s ee Memorandum, DP # 376980 titled, Fluxapy roxad (BAS 700F), Issues for Consideration by Residues of Concern Knowledge
- Base Subcommittee