Page 2 of 19

1.0 Executive Summary

Fluxapyroxad (1H-Pyrazole-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 

fungicides. Furthermore, fluxapyroxad is a broad based fungicide that provides preventive seed 

and seedling protection from 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 

fluxapyroxad. All other active ingredients are assessed in separate memoranda. 

Proposed Use Profile

The proposed use of the fungicide fluxapyroxad (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. Fluxapyroxad (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-type seed treatment equipment. 

There is a potential for short- and intermediate-term occupational exposure to fluxapyroxad 

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 have 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 plus 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 was based on a 28 day dietary study in rats, where changes in thyroid 

hormone levels and thyroid follicular hypertrophy/hyperplasia were observed. A NOAEL of 7.3 

mg/kg/day was selected for the intermediate-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/hyperplasia 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). 

Fluxapyroxad has low acute oral, dermal, and inhalation toxicity, registering toxicity categories 

of (III, III, and IV), respectively. Fluxapyroxad is not irritating to the eyes, only slightly 

irritating to the skin, and not a dermal sensitizer.

Fluxapyroxad 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 

treatment (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 LOC, and therefore, are not of concern to 

HED. 

Occupational Post-Application – Foliar Applications

The potential for short-and intermediate-term exposure to fluxapyroxad during occupational 

post-application activities is likely; however 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 fluxapyroxad during 

post-application activities is unlikely because sustained 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 

fluxapyroxad 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 exposed 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 fluxapyroxad 

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 fluxapyroxad. 

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 intermediateterm 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 follicular hypertrophy/hyperplasia were observed.

A NOAEL of 7.3 mg/kg/day was selected for the intermediate-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/hyperplasia 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 occupational LOC 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 assigned. Fluxapyroxad is characterized as “not likely to be carcinogenic to humans”; 

therefore, cancer risk was not assessed. The acute toxicity and endpoint selections for 

fluxapyroxad are summarized in Tables 1 and 2, respectively.

Table 1. Acute Toxicity Profile for Fluxapyroxad

GDLN Study Type MRID Results Tox Category

870.1100 Acute Oral [rat] 47593558 LD50 >2,000 mg/kg III

870.1200 Acute Dermal [rat] 47593559 LD550 >2,000 mg/kg III

870.1300 Acute Inhalation [rat] 47593560 LC550 >5.1 mg/L/ 4 hr IV

870.2400 Acute Eye Irritation 

[White New Zealand rabbit] 47593562 Not irritating IV

870.2500 Acute dermal Irritation [rabbit] 47593561 Slight dermal irritant IV

870.2600 Dermal Sensitization [Guinea Pig] 47593562 Not a sensitizer IV
Page 5 of 19

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 (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

Fluxapyroxad belongs to the succunate-dehydrogenase (SDH) inhibitor class of fungicides. 

Fluxapyroxad is a fungicide that provides preventive seed and seedling protection from several 

seed and soil borne diseases. 

The proposed use of the fungicide fluxapyroxad (BAS 700F) is for seed and foliar applications 

on cereal grains, 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. 

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 

identified and therefore 

quantification is not 

required

Inhalation Short-Term

(1-30 days)

NOAEL= 9 

mg/kg/day

UFA= 10 x

UFH=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 IntermediateTerm (1-6 months)

NOAEL= 7.3 

mg/kg/day

UFA= 10 x

UFH=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 humans
Page 6 of 19

Fluxapyroxad (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-type seed treatment equipment. 

A summary of the proposed use profile is presented in Tables 3a and 3b. 

Table 3a. Summary of Directions for Use of Fluxapyroxad.

Product 

[EPA File

Reg. No.]

Formulation

type

Crops Application

Method

Max. Application. 

Rates

(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)

Emulsifiable 

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 corn vegetables (incl. 

potatoes),cereal grains, 

peanut, sorghum, cotton, 

soybean

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 Directions for Use of Fluxapyroxad on Seed.

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 MistType Application 

Equipment

Range from

0.0001 - 0.0005 lb ai/lb seed

(2.36 oz./100 lbs of seed)

Depending on crop seed

Soybean

Sunflower and 

safflower

Cereal Grains (CG 

15 and 16)

Sorghum

Cotton

Peanut
Page 7 of 19

4.0 Residential (Non-Occupational) Exposure/Risk Characterization

There are no residential uses proposed for fluxapyroxad in this registration action, therefore a 

residential exposure assessment was not conducted.

Residential Bystander Post-Application Inhalation Exposure

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for fluxapyroxad 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 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/2009/120109meeting.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 postapplication 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 fluxapyroxad.

Spray Drift

Spray drift is always 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 employed for fluxapyroxad. 

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 website 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 Agency 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 appropriately apply the data and the AgDRIFT computer model to 

its risk assessments for pesticides applied by 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 performed 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 Exposure/Risk Characterization

There is a potential for short- and intermediate-term occupational exposure to fluxapyroxad 

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 fluxapyroxad. 

5.1 Occupational Handler (Foliar application)

The anticipated use patterns and current labeling indicate several occupational scenarios based 

on types of equipment and techniques that can potentially be used for fluxapyroxad applications. 

For the purpose of this exposure/risk assessment, the occupational handler scenarios are shortand intermediate-term in duration and are as follows:

Mixer/Loader

1. Open mixing/loading for aerial application;

2. Open mixing/loading for groundboom application;

3. Open mixing/loading for airblast application;

Applicator

1. Applying sprays via aerial applications;

2. Applying sprays via groundboom applications; 

3. Applying sprays via airblast applications;

4. Applying sprays via chemigation (covered by 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

strongly encourages the use of the engineering control system, 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, shoes, 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 fluxapyroxad 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

fluxapyroxad while performing seed treatment activities in commercial settings. In addition, 

occupational secondary handlers may experience short- and intermediate-term exposure while 

planting fluxapyroxad-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 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 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 fluxapyroxad as a commercial seed 

treatment include:

 Mixing, loading, applying liquid formulations;

 Bagging treated seed;

 Sewing bags; and

 Multiple activities.

Typically, 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” scenario (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 fluxzpyroxad 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 fluxapyroxad product labels for seed treatment recommend applicators and other handlers to 

wear long-sleeved shirt and long pants, and shoes plus socks.

5.3 Exposure Data, Factors and Assumptions 

1. Application Rates

The proposed treatment range is 0.09 – 0.18 lb ai/acre for aerial, groundboom, and airblast
Page 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 yearly) are shown in Table 3a 

and 3b. The maximum single application rates were used in the risk assessment.

2. Body Weight

The average adult weight of 80 kg was used for estimating inhalation exposure.

3. Exposure Duration

It is anticipated that occupational fluxapyroxad exposures will generally occur in short- (1-30 

days) 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 apply these products over a period of weeks, because they are commercial 

applicators who are completing multiple applications for multiple clients. Long-term exposures 

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 oral 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 chemicalspecific monitoring data are not available, HED relies on the most scientifically-reliable 

surrogate data currently available from various sources such as the Pesticide Handlers Exposure 

Database (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 by 

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 Values 
Page 11 of 19

for Daily Acres Treated in Agriculture”, which was revised on July 5, 2000. Values used for 

area treated in each scenario included 350 and 1200 acres for applications with fixed-wing 

aircraft (crop specific), 350 acres for flagging, 80 and 200 acres for groundboom applications

(crop specific), 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 type. 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

 Soybean - 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/Applicator = 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,

 Soybean - 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 – 800 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 daily dose (inhalation) was calculated by adjusting the daily inhalation 

exposure values by body weight and accounting for inhalation absorption. For adult handlers 

using fluxapyroxad, an average body weight of 80 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 = 80 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 exposures

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 cockpits. 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 (long-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 exposures 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, therefore, 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 daily 

amount of seed treated in commercial seed treatment facilities. With the increasing demand for 

hybridized treated seeds, there have been modifications not only in the seed treatment 

equipment, but in the market shares of new and currently registered pesticide products. HED 

understands that due to the high cost of producing hybrid seeds, direct seeding is done in a 

precision 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 from 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

230,000 190,000

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

460,000 370,000

corn, soybean, wheat 200 180,000 150,000

Airblast

(open cab) stone fruits 0.11 40 750,000 610,000

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

340,000 270,000

Dried shelled beans 0.18 170,000 140,000

corn, soybean, wheat 0.09 1200 98,000 80,000
Page 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

ShortTerm6Intermediate

-term

Inhalation

Applicator

Groundboom 

(open Cab)

Chemigation7

0.068

Dried shelled beans 0.18

80

150,000 120,000

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

290,000 240,000

corn, soybean, wheat 200 120,000 95,000

Airblast

(open cab) Stone fruits 0.11 40 36,000 29,000

Flagging 

Aerial

Fixed Wing

(enclosed cockpit)

0.35 corn, soybean, wheat50.18 350 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 each exposure scenario of concern based on the application method 

and formulation/packaging type. (standard EPA/OPP/HED values).

5Corn, 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 absorption factor * Application rate * Area treated} / 70 kg. 

Table 5. Summary of Short- and Intermediate-Term Handler Exposures and Risks for Fluxapyroxad (Seed 

Treatment Only).

Seed Type

Inhal 

UEa

Max App 

Rateb

Amt 

Treatedc

Inhalation

Dosed

Short-Term 

Inhalation

MOEe

Intermediate-Term 

Inhalation

MOEf

mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100

LOADER/APPLICATOR (no respirator)

Peanuts 0.00034 0.0001 120,000 0.000051 180,000 140,000

Dried Shelled 

Beans 0.00034 0.0001 194,000 0.000082 110,000 89,000

Soybean 0.00034 0.0001 718,000 0.00031 29,000 24,000
Page 16 of 19

Table 5. Summary of Short- and Intermediate-Term Handler Exposures and Risks for Fluxapyroxad (Seed 

Treatment Only).

Seed Type

Inhal 

UEa

Max App 

Rateb

Amt 

Treatedc

Inhalation

Dosed

Short-Term 

Inhalation

MOEe

Intermediate-Term 

Inhalation

MOEf

mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100

Cereal Grains 0.00034 0.0005 718,000 0.00150 5,900 4,800

Corn 0.00034 0.0005 550,000 0.00120 7,700 6,200

Cotton 0.00034 0.0002 160,000 0.00014 66,000 54,000

Sunflower and 

safflower 0.00034 0.0002 718,000 0.00061 15,000 12,000

Sorghum 0.00034 0.0002 718,000 0.00061 15,000 12,000

SEWER (no respirator)

Peanuts 0.00023 0.0001 718,000 0.00021 44,000 35,000

Dried Shelled 

Beans 0.00023 0.0001 194,000 0.00006 160,000 130,000

Soybean 0.00023 0.0001 718,000 0.00021 44,000 35,000

Cereal Grains 0.00023 0.0005 718,000 0.00100 8,700 7,100

Corn 0.00023 0.0005 550,000 0.00079 11,000 9,200

Cotton 0.00023 0.0002 160,000 0.00092 98,000 79,000

Sunflower and 

safflower 0.00023 0.0002 718,000 0.00041 22,000 18,000

Sorghum 0.00023 0.0002 718,000 0.00041 22,000 18,000

BAGGER (no respirator)

Peanuts 0.00016 0.0001 718,000 0.00014 63,000 51,000

Dried shelled 

Beans 0.00016 0.0001 194,000 0.00004 230,000 190,000

Soybean 0.00016 0.0001 718,000 0.00014 63,000 51,000

Cereal Grains 0.00016 0.0005 718,000 0.00072 13,000 10,000

Corn 0.00016 0.0005 550,000 0.00055 16,000 13,000

Cotton 0.00016 0.0002 160,000 0.00006 140,000 110,000

Sunflower and 

safflower 0.00016 0.0002 718,000 0.00029 31,000 25,000

Sorghum 0.00016 0.0002 718,000 0.00029 31,000 25,000

MULTIPLE ACTIVITIES (no respirator)

Peanuts 0.0016 0.0001 718,000 0.00140 6,300 5,100

Dried Shelled 

Beans 0.0016 0.0001 194,000 0.00039 23,000 19,000
Page 17 of 19

Table 5. Summary of Short- and Intermediate-Term Handler Exposures and Risks for Fluxapyroxad (Seed 

Treatment Only).

Seed Type

Inhal 

UEa

Max App 

Rateb

Amt 

Treatedc

Inhalation

Dosed

Short-Term 

Inhalation

MOEe

Intermediate-Term 

Inhalation

MOEf

mg/lb lb ai/lb seed lb seed/day mg/kg/day LOC = 100 LOC = 100

Soybean 0.0016 0.0001 718,000 0.00140 6,300 5,100

Cereal Grains 0.0016 0.0005 718,000 0.00720 1,300 1,200

Corn 0.0016 0.0005 550,000 0.00550 1,600 1,300

Cotton 0.0016 0.0002 160,000 0.00064 14,000 11,000

Sunflower and 

safflower 0.0016 0.0002 718,000 0.00290 3,100 2,500

Sorghum 0.0016 0.0002 718,000 0.00290 3,100 2,500

PLANTERS (no respirator)

Peanuts 0.0034 0.0001 11,000 0.000047 190,000 210,000

Dried Shelled 

Beans 0.0034 0.0001 8,000 0.000034 260,000 190,000

Soybean 0.0034 0.0001 20,000 0.000085 110,000 86,000

Cereal Grains 0.0034 0.0005 26,000 0.00011 81,000 66,000

Corn 0.0034 0.0005 3,000 0.000064 140,000 110,000

Cotton 0.0034 0.0002 3,600 0.000031 290,000 240,000

Sunflower and 

safflower 0.0034 0.0002 800 0.000068 1,300,000 1,100,000

Sorghum 0.0034 0.0002 800 0.000068 1,300,000 1,100,000

a Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment. 

b Application Rates based on proposed 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 peas, 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 fluxapyroxad at this time; an inhalation 

exposure assessment was performed for occupational handlers. This assessment 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 performing 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/2009/120109meeting.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 fluxapyroxad.

Dermal: A quantitative post-application dermal exposure assessment was not performed since 

no hazard was identified via the dermal route for fluxapyroxad.

Dermal: The potential for post-application dermal exposures following the planting of 

fluxapyroxad-treated seeds is unlikely because sustained levels of contact with treated seed after 

it has been placed in the soil or other planting media would not be expected because 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 exposure 

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 fluxapyroxad, occupational handler and post 

application exposure scenarios did not result in risk estimates of concern. MOEs were ≥100 and 

therefore, risk estimates did not exceed the Level of Concerns (LOC) at the maximum proposed 

application rates. Furthermore, an inhalation study is not required at this time and fluxapyroxad 

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/pesticides/science/handler-exposure-data.html). 

 Pesticides Handlers Exposure Database (PHED)Version 1.1; dated 8/98, AHETF, (HED 

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

 End Point Selection; [(see Memorandum, DP # 376980 titled, Fluxapyroxad (BAS 700F), 

Issues for Consideration by Residues of Concern Knowledge-Base Subcommittee