UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Date: 7/23/2013 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Fluxapyroxad; Occupational and Residential Exposure Assessment for a 

Proposed Use on a wide range of food and seed commodities. 

PC Code: 138009 DP Barcode: 403943, 404520, 404524, 

404525, 404527,404529, 404532, 405413 

Decision No.: 466686, 4 75980, 466653 Registration No.: 7969-306, 7969-307, 

7969-308, 7969-309, 7969-310, 7969-311 , 

7969-312, 7969-GLE, 7969-GUO, 7969-

GLN 

Petition No.: 2F8053, 2F8058, & 3F8161 Reeulatory Action: Section 3 Registration 

Risk Assessment Type: Single Chemical Aggregate Case No.: 3125 

TXRNo.: NA CAS No.: 907204-31-3 

MRIDNo.: NA 40 CFR: 180.666 

FROM: James 

Angela 

S. 

Howard, 

Miller, E

PhD., 

nvironmental 

Toxicologist 

Scientist c;::1 <f~ J{ ~ 

Risk 

Health 

Assessment 

Effects Division 

Branch 

(7509P) 

4 

1\ _/~ 

~ 

THROUGH: ~a S. Davis, Acting Chief ~(~ _ V fJt..~ n'-f1'-<- l 

Susan V. Hummel, Branch Senior ~tt""'-

Thurston G. Morton, Chemist 

Risk Assessment Branch 4, HED (7509P) 

TO: Olga Odiott, Risk Manager 

Fungicide Branch 

Registration Division (7505P) 

Introduction 

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an 

exposure and risk assessment for the proposed new uses of the active ingredient fluxapyroxad on 

a wide range of food and seed commodities. It is HED policy to use the best available data to 

assess exposure. Several sources of generic data were used in this assessment as surrogate data 

in the absence of chemical-specific data, including Pesticide Handlers Exposure Database 

Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) 

Page I of34 
database; the Outdoor Residential Exposure Task Force (ORETF) database; the 

Agricultural Reentry Task Force (ARTF) database; ExpoSAC Policy 14 (SOPs for Seed 

Treatment), and the Residential SOPs (section 3 "Lawns and Turf'). Some of these data are 

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

and Rodenticide Act (FIFRA). 

Page 2 of34 
Page 3 of 34

Table of Contents

1.0 Executive Summary............................................................................................................. 4

2.0 Risk Assessment Conclusions and Recommendations........................................................ 6

2.1 Data Deficiencies and Requirements ............................................................................... 7

3.0 Hazard Characterization....................................................................................................... 7

4.0 Use Profile ........................................................................................................................... 9

5.0 Residential Exposure and Risk Estimates.......................................................................... 13

5.1 Residential Handler Exposure/Risk Estimates............................................................... 14

5.2 Residential Post-application Exposure/Risk Estimates.................................................. 15

5.3 Residential Risk Estimates for Use in Aggregate Assessment ...................................... 16

5.4 Spray Drift...................................................................................................................... 17

5.5 Residential Bystander Post-Application Inhalation Exposure ....................................... 17

6.0 Occupational Exposure and Risk Estimates ...................................................................... 18

6.1 Occupational Handler Exposure/Risk Estimates............................................................ 18

6.2 Occupational Post-application Exposure/Risk Estimates .............................................. 25

6.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates...................... 26

Appendix A. Summary of Occupational and Residential Non-cancer Algorithms..................... 27
Page 4 of 34

1.0 Executive Summary

Fluxapyroxad (3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1Hpyrazole-4-carboxamide) is a fungicide belonging to the carboxamide class of chemicals. It is 

currently registered for use on a wide range of crops to control a broad spectrum of fungal 

diseases. Fluxapyroxad is a pyrazole carboxamide. This assessment provides information to 

support a Section 3 registration for the use of the fungicide fluxapyroxad for seed and foliar uses 

on bulb vegetables, leafy vegetables, brassica vegetables, cucurbit vegetables, and root and tuber 

vegetables (subgroup 1B). Also, for foliar uses on the caneberry subgroup, bushberry subgroup, 

small fruit vine climbing subgroup, low growing berry subgroup, turf, tree nuts and sugarcane. 

In addition, the registrant is amending the tolerance for the stone fruit crop group, and amending

the use on rice. This document addresses the exposures and estimated risk associated with the 

proposed new and amended uses of fluxapyroxad. 

Proposed Use Profile

The quantitative Inhalation only exposure/risk assessment developed is based on individuals 

involved commercial seed treatment (primary handlers), and planting treated seeds (secondary 

handlers) as well as aerial, flagging, airblast, chemigation, mechanically pressurized handgun, 

and groundboom applicators as well as residential handler applications to turf using a hose-end 

sprayer, a manually pressurized handgun, and a backpack sprayer. 

The formulations are Imbrex Xemium Brand Fungicide (7969-306, an emulsifiable concentrate 

(EC) containing 5.96% fluxapyroxad, 0.52 lb ai/gal with application rates ranging from 0.09 to 

0.18 lb ai per acre and a PHI range of 0-28 days.); Xemium 2.78 Fungicide ST (7969-307, for 

seed treatment, 28.78% ai, 2.78 lbs ai/gal with application rates ranging from 0.02 to 0.25 lb ai 

per 100 lb of seed); Xemium 2.72 Fungicide ST (7969-308, for seed treatment, 28.70% ai, 2.72 

lbs ai/gal with application rates ranging from 0.02 to 0.25 lb ai per 100 lb of seed); Sercadis

Xemium Brand Fungicide (7969-309, EC formulation with 26.55% ai, 2.47 lb ai/gal with 

application rates ranging from 0.09 to 0.18 lb ai per acre and a PHI range of 0-28 days); Merivon 

Xemium Brand Fungicide (7969-310, with fluxapyroxad at 21.26% ai, 2.09 lb ai/gal with 

application rates ranging from 0.09 to 0.18 lb ai per acre and a PHI range of 0-14 days), and 

Priaxor Xemium Brand Fungicide (7969-311, with fluxapyroxad at 14.33% ai, 1.39 lb ai/gal with 

application rates ranging from 0.06 to 0.10 lb ai per acre and a PHI range of 0-29 days); along 

with a new product Xemium 703 Fungicide ST (7969-GLE, for seed treatment, 21.26% ai, 2.09 

lbs ai/gal with application rates ranging from 0.01 to 0.08 lb ai per 100 lb of seed). 

In addition, there are two proposed new products for turf use. These products are Xzemplar 

Fungicide (7969-GUO, 26.55% ai, 2.47 lb ai/gal with application rates ranging from 0.14 to 0.22 

lb ai per acre and a RTI of 14 days) and Lexicon Intrinsic Fungicide (7969-GLN, 14.33% ai, 

1.39 lb ai/gal with application rates ranging from 0.16 to 0.23 lb ai per acre and a RTI of 14 

days). The pre-harvest interval (PHI) ranges from 0 day up to 28 days depending on the crop, 

with a 14 to 28 day RTI for turf and the restricted entry interval (REI) or 12 hours for all 

crops/labels. The proposed labels allow for applications via aerial, groundboom, chemigation 

and/or airblast equipment depending on the crop. The proposed labels require occupational 

handlers to wear the following personal protective equipment (PPE): mixers, loaders, applicators 

and other handlers (seed treatment activities) wear long-sleeved shirt and long pants, chemical 
Page 5 of 34

resistant gloves, protective eyewear, and shoes plus socks. However, as noted above only 

inhalation exposure was accessed.

Exposure Profile

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

inhalation 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. Residential handler and 

incidental oral exposures were assessed for homeowner applications to turf. 

Hazard Concerns

The POD for short-term inhalation exposure [No Observable Adverse Effect Level (NOAEL) = 

9 mg/kg/day] was selected from the 28-day dietary study in rats based on thyroid effects (thyroid 

follicular hypertrophy/hyperplasia). The POD for intermediate-term inhalation exposure [No 

Observable Adverse Effect Level (NOAEL) = 7.3 mg/kg/day] was selected from a 90-day 

dietary study in rats based also on thyroid effects. The POD for short-term incidental Oral 

exposure [No Observable Adverse Effect Level (NOAEL) = 9 mg/kg/day] was selected from a 

28 day toxicity study in rats based on changes in thyroid hormones and thyroid follicular 

hypertrophy/hyperplasia. PODs for short- and intermediate-term dermal exposure were not 

selected. No hazards were identified for exposures via the dermal route in a 28-day dermal 

toxicity study at the limit dose and the dermal absorption study indicates that there is low 

absorption (8.38%) via the dermal route in rats. Further, although developmental toxicity was 

not assessed in the dermal toxicity study, the Agency has low concern for developmental toxicity

for fluxapyroxad. An uncertainty factor of 100x was applied to endpoints selected for all 

exposure routes (10x for interspecies extrapolation, 10x for intraspecies variation).

Oral studies were extrapolated for assessment of inhalation hazards, since no repeated-dose 

inhalation studies were available. The HASPOC met on January 17, 2013 to discuss the need for 

a subchronic inhalation study for fluxapyroxad (TXR # 0056561). The decision was made that 

this requirement could be waived and a subchronic inhalation study is not required. The weight 

of the evidence used to support this decision included: the low acute inhalation toxicity of 

fluxapyroxad, the low volatility of fluxapyroxad and the large margin of exposure demonstrated 

in the exposure assessment.

Fluxapyroxad is classified as “not likely” to be carcinogenic; therefore a quantitative cancer 

assessment was not conducted. 

Residential Exposure and Risk

Residential Handlers

The residential handler exposure and risk estimates indicate that short-term inhalation MOEs are 

not of concern to HED (i.e., MOEs > 100).The inhalation MOEs range from 420 to 280,000.

Residential Post-application 

The residential incidental oral, hand to mouth, object to mouth, soil ingestion exposures and risk 

estimates indicate that short-term MOEs are not of concern to HED (i.e., MOEs > 100). The
Page 6 of 34

MOEs range from 2,600 to 1,200,000. The aggregate MOE is 2,600 and not of concern to HED 

(i.e., MOEs > 100).

Occupational Exposure and Risk

Occupational Handlers

The occupational handler exposure and risk estimates indicate that short- and intermediate-term

inhalation MOEs are not of concern to HED (i.e., MOEs > 100). The inhalation MOEs range 

from 16,000 to 330,000.

Seed Treatment

Seed treatment (primary and secondary handler) occupational handler estimates indicate that 

short- and intermediate-term inhalation MOEs are not of concern to HED (i.e., MOEs > 100). 

The inhalation MOEs range from 1,100 to 8,800,000,000.

Occupational Post-Application

Based on the Agency's current practices, a quantitative non-cancer occupational post-application 

inhalation exposure assessment was not performed for fluxapyroxad at this time. 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. Although a quantitative 

occupational post-application inhalation exposure assessment was not performed, an occupation 

inhalation exposure assessment was performed. 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. 

Human Studies Review

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. These data, which include [studies from 

PHED 1.1; the AHETF database; the Outdoor Residential Exposure Task Force (ORETF) 

database; the ARTF database; ExpoSAC Policy 14 (SOPs for Seed Treatment); the 

Residential SOPs (list specific SOP); other registrant-submitted exposure monitoring 

studies (list MRID); published literature study, etc], are (1) subject to ethics review pursuant 

to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics 

requirements. For certain studies, the ethics review may have included review by the Human 

Studies Review Board. Descriptions of data sources, as well as guidance on their use, can be 

found at the Agency website1. 

2.0 Risk Assessment Conclusions and Recommendations

There are no occupational or residential risk estimates of concern associated with the proposed 

new uses of fluxapyroxad (i.e., MOEs > 100). 

 

1

http://www.epa.gov/pesticides/science/handler-exposure-data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html
Page 7 of 34

2.1 Data Deficiencies and Requirements

Turf Transferable Residue (TTR): In accordance with the updated Part 158 data requirements 

(2007), a TTR study is required for all occupational (e.g., sod farms, golf courses, parks, and 

recreational areas) or residential turf uses. As part of the recent revision to the Health Effects 

Division’s 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment, 

HED analyzed all available data and selected new liquid and granular default values for the 

fraction of the application rate available for transfer after a turf application (FAR).

2

 These 

defaults are 1% for formulations applied as liquids (i.e., emulsifiable concentrates, liquids, 

wettable powders, dry flowables, etc.) and 0.2% for granular formulations. Of the available TTR 

studies submitted to the Agency, the maximum FAR value seen using a liquid product was 6.1%

or 6.1 times higher than the default residue transfer value. The maximum FAR value seen in a 

TTR study using a granular product was 0.69% or 3.5X the default residue transfer value. 

Therefore, for both liquid and granular formulations, a calculated MOE of approximately 10 

times higher than the level of concern (e.g., an MOE > 1,000 if the LOC = 100) using the default 

residue transfer values would provide an adequate margin of safety for any potentially higher 

residues seen in a chemical-specific TTR study (Guidance for Requiring/Waiving Turf 

Transferrable Residue (TTR) and Dislodgeable Foliar Residue (DFR) Studies. 6/7/2012, 

Exposure Science Advisory Council). A TTR study is not required for fluxapyroxad at this time 

since the [ hand-to-mouth] MOE is greater than]10 times the LOC based on default values for the 

fraction of application rate available for transfer after a turf application.

Dislodgeable Foliar Residue (DFR): No hazards were identified for exposures via the dermal 

route; therefore no DFR related information was used in this assessment.

3.0 Hazard Characterization

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.

 

2

http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 8 of 34

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. Table 1 presents a summary of the acute 

toxicity information for fluxapyroxad.

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

Table 2 Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in 

Residential and Occupational Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of 

Concern for Risk 

Assessment

Study and Toxicological Effects

Dermal Shortand 

IntermediateTerm

No hazard identified 28-day dermal toxicity study in rats

LOAEL = Not observed

Inhalation 

Short-Term 

(1-30 days)

NOAEL= 9

mg/kg/day

UFA=10x

UFH=10x

Occupational/

Residential LOC 

for MOE = 100

28-day oral toxicity study in rats

LOAEL = 176 mg/kg/day based on 

changes in thyroid hormones and 

thyroid follicular 

hypertrophy/hyperplasia

Inhalation 

Intermediateterm

(1-6 months)

NOAEL= 7.3

mg/kg/day

UFA=10x

UFH=10x

Occupational/

Residential LOC 

for MOE = 100

LOAEL = 35.1 mg/kg/day based on 

thyroid follicular 

hypertrophy/hyperplasia

Incidental 

Oral ShortTerm

(1-30 days)

NOAEL= 9

mg/kg/day

UFA=10x

UFH=10x

Residential LOC 

for MOE = 100

28-day oral toxicity study in rats

LOAEL = 176 mg/kg/day based on 

changes in thyroid hormones and 

thyroid follicular 

hypertrophy/hyperplasia
Page 9 of 34

Table 2 Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in 

Residential and Occupational Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of 

Concern for Risk 

Assessment

Study and Toxicological Effects

Cancer (oral, 

dermal, 

inhalation)

Classification: Not likely to be carcinogenic to humans at doses sufficient to induce liver 

and/or thyroid tumors.

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). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

Absorption

A dermal absorption factor was not used for the exposure assessment. Since no inhalation 

absorption data are available, toxicity by the inhalation route is considered to be equivalent to the 

estimated toxicity by the oral route of exposure.

Body Weight

The standard body weight for the general population (80 kg) was used for all exposure scenarios 

covered in this risk assessment since the endpoints selected were not developmental and/or fetal 

effects.

4.0 Use Profile 

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. A summary of the proposed use profile is presented in Tables 3.
Page 10 of 34

Table 3. Summary of Directions for Use of Fluxapyroxad

Appl. Timing, 

Type, and 

Equip.

Formulation

Applic. Rate

(lb ai/A)

(lb ai/100lb 

seed) for 

seed 

treatment

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Berries and Small Fruits (inc caneberries, bushberries, strawberries, etc)

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.18 3 0.54

0

(caneberry, 

bushberry, lowgrowing berry)

14

(grape and small 

fruit vine 

climbing 

subgroup)

Use Directions and Limitations: A minimum 7-day RTI is specified. Mix Imbrex (7969-306), 

Sercadis (7969-309), Merivon (7969-310), Priaxor (7969-311) with water only for crops in the 

caneberry and bushberry crop group. Do not make more than 2 sequential applications before 

alternating to a labeled non-Group 7 fungicide. Not registered in CA.

Brassica Vegetables

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.09 3 0.27 3

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not make more than 2 

sequential applications before alternating to a labeled non-Group 7 fungicide. Not registered in 

CA.

Seed 

Treatment

28.78% SC (7969-307)

28.7% SC (7969-308)

21.26% (7969-GLE)

0.04

0.08 (GLE)

Not 

applicable

Not 

applicable Not applicable

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Bulb Vegetables

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.18 3 0.54 7

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not make more than 2 

sequential applications before alternating to a labeled non-Group 7 fungicide. Not registered in 

CA.

Seed 

Treatment

28.78% SC (7969-307)

28.7% SC (7969-308)

21.26% (7969-GLE)

0.04 (0.25 

for onion 

smut)

0.08 (GLE)

Not 

applicable

Not 

applicable Not applicable
Page 11 of 34

Table 3. Summary of Directions for Use of Fluxapyroxad

Appl. Timing, 

Type, and 

Equip.

Formulation

Applic. Rate

(lb ai/A)

(lb ai/100lb 

seed) for 

seed 

treatment

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Cucurbit Vegetables

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.09 3 0.27 0

Use Directions and Limitations: A minimum 7-day RTI is specified. Mix Imbrex (7969-306), 

Sercadis (7969-309), Merivon (7969-310), Priaxor (7969-311) with water only. Do not make 

more than 2 sequential applications before alternating to a labeled non-Group 7 fungicide. Not 

registered in CA.

Seed 

Treatment

28.78% SC (7969-307)

28.7% SC (7969-308)

21.26% (7969-GLE)

0.04

0.06 (GLE)

Not 

applicable

Not 

applicable Not applicable

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Grapes

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.09 (0.18) 6 (3) 0.54 14

Use Directions and Limitations: A minimum 10-day RTI is specified. The safety of all possible 

tank mixtures with Imbrex (7969-306), Sercadis (7969-309), Merivon (7969-310), Priaxor 

(7969-311) has not been tested. Safety should be confirmed prior to application. Do not make 

more than 2 sequential applications before alternating to a labeled non-Group 7 fungicide. Not 

registered in CA.

Leafy Vegetables

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.18 3 0.54 1

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not apply Imbrex, 

Sercadis, Merivon, Priaxor to spinach as a tank mix. The safety of all possible tank mixtures 

with Imbrex (7969-306), Sercadis (7969-309), Merivon (7969-310), Priaxor (7969-311) has not 

been tested on leafy vegetables. Safety should be confirmed prior to application. Do not make 

more than 2 sequential applications before alternating to a labeled non-Group 7 fungicide. Not 

registered in CA except for lettuce drop on leaf and head lettuce.

Seed 

Treatment

28.78% SC (7969-307)

28.7% SC (7969-308)

21.26% (7969-GLE)

0.04-2 

depending on 

target disease

0.06 (GLE)

Not 

applicable

Not 

applicable Not applicable
Page 12 of 34

Table 3. Summary of Directions for Use of Fluxapyroxad

Appl. Timing, 

Type, and 

Equip.

Formulation

Applic. Rate

(lb ai/A)

(lb ai/100lb 

seed) for 

seed 

treatment

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Rice

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309) 0.13 2 0.27 28

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not make more than 2 

sequential applications before alternating to a labeled non-Group 7 fungicide. Not registered in 

CA.

Seed 

Treatment

28.78% SC (7969-307)

28.7% SC (7969-308) 0.05 Not applicable

Not 

applicable Not applicable

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Root Vegetables Crop Subgroup 1B

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.09 3 0.27 7

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not make more than 2 

sequential applications before alternating to a labeled non-Group 7 fungicide. Not registered in 

CA.

Seed 

Treatment

28.7% SC (7969-308)

21.26% (7969-GLE)

0.04

0.06 (GLE)

Not 

applicable

Not 

applicable Not applicable

Use Directions and Limitations: Rate is expressed in lb ai/100 lb seed. Apply in enough water 

to ensure adequate coverage, but without damaging the seed.

Sugarcane

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

14.33% EC (7969-311)

0.11 2 0.22 14

Use Directions and Limitations: A minimum 7-day RTI is specified. Do not make more than 2 

sequential applications before alternating to a labeled non-Group 7 fungicide. Not registered in 

CA.

Tree Nuts

Ground, 

Aerial or 

Chemigation

5.96% EC (7969-306)

26.55% EC (7969-309)

21.26% EC (7969-310)

14.33% EC (7969-311)

0.11 3 0.33 14

Use Directions and Limitations: A minimum 7-day RTI is specified except for pistachio which 

has an RTI of 10 days. Do not make more than 2 sequential applications before alternating to a 

labeled non-Group 7 fungicide. For aerial do not use less than 10 gallons of spray solution per 

acre. Not registered in CA.
Page 13 of 34

Table 3. Summary of Directions for Use of Fluxapyroxad

Appl. Timing, 

Type, and 

Equip.

Formulation

Applic. Rate

(lb ai/A)

(lb ai/100lb 

seed) for 

seed 

treatment

Max. No. 

Applic. per 

Season

Max. 

Seasonal 

Applic. 

Rate

(lb ai/A)

PHI

(days)

Turf

Ground, 

Aerial, 

Chemigation, 

and/or 

Mechanically 

Pressurized 

Hand Gun

26.55% SC (7969-GUO)

14.33% SC (7969-GLN) 0.23 N/A 0.80 N/A

Use Directions and Limitations: A 14-28 day RTI is specified for turf applications. Do not 

make more 2 sequential applications in the Fall and Spring, or more than 0.80 lbs ai/Acre per 

Acre per season. Do not make more than 2 sequential applications before alternating to a 

labeled non-Group 7 fungicide. Aerial applications are to be conducted for Sod farms only with 

a 100 ft. buffer in the State of NY.

1. The restricted entry interval (REI) is 12 hours for all crops/labels 

5.0 Residential Exposure and Risk Estimates

The proposed uses are expected to result in residential exposure: therefore, a quantitative 

residential exposure assessment was conducted. A summary of the proposed use profile is 

presented in Table 4.

Table 4. Short-Term Residential Handler Exposure and Risk Estimates for Fluxapyroxad.

Exposure 

Scenario

Target 

MOE

Inhl. Unit 

Exposure 

(ug/lb ai)

Maximum 

Application Ratea

(lb ai/gal)

Or

(lb ai/Acre)

Area 

Treatedb

Inhalation

Dose 

(mg/kg/day)c MOEd

Mixer/loader/Applicator (Turf-Lawns)

Hose-end 

Sprayer/

100

0.022 0.23 0.5 Acres 0.000032 280,000

ManuallyPressurized 

Handwand

0.018

2.47 5 Acres

0.0028 3,200

Backpack 

Sprayer 0.14 0.022 420

Based on registered or proposed label (0.023 lb ai/A) and (2.47 lb ai/gal):

Exposure Science Advisory Council Policy #9.1.

Inhalation Dose = Inhalation Unit Exposure (ug/lb ai) x Conversion Factor (0.001 mg/ug) x Application Rate (lb ai/acre or gal) x Area Treated or 

Amount Handled (A or gallons/day) / BW (kg).

Inhalation MOE = Inhalation NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day).
Page 14 of 34

5.1 Residential Handler Exposure/Risk Estimates

HED uses the term “handlers” to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct tasks related to applications and that 

exposures can vary depending on the specifics of each task. Residential handlers are addressed 

somewhat differently by HED as homeowners are assumed to complete all elements of an 

application without use of any protective equipment.

The quantitative exposure/risk assessment developed for residential handlers is based on the 

following scenarios: 

1. Open mixing/loading/applying for a hose-end sprayer application to turf (homeowner 

lawns);

2. Open mixing/loading/applying for a manually pressurized handgun. application to turf 

(homeowner lawns);

3. Open mixing/loading/applying for a backpack sprayer application to turf (homeowner 

lawns).

Residential Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

handler risk assessments. Each assumption and factor is detailed below.

Application Rate:

See table 4 for specifics.

Unit Exposures and Area Treated or Amount Handled:

Unit exposure values and estimates for area treated or amount handled were taken from HED’s 

2012 Residential SOPs3. See table 4 for specifics.

Exposure Duration: 

Residential handler exposure is expected to be short-term in duration. Intermediate-term

exposures are not likely because of the intermittent nature of applications by homeowners; 

however, there are some instances where longer-term exposures are possible (e.g., pet care uses).

Residential Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate exposure and dose for residential handlers can be found in 

Appendix A and/or the 2012 Residential SOPs4.

Summary of Residential Handler Non-Cancer Exposure and Risk Estimates

Fluxapyroxad does not pose a dermal risk; therefore, only inhalation exposures for handlers were 

calculated. For all residential handler exposure scenarios, inhalation MOEs exceed HED’s LOC 

(inhalation LOC = 100), and therefore not of concern to HED (i.e., MOEs > 100). See table 4 

for specifics.

 

3 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html

4 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 15 of 34

5.2 Residential Post-application Exposure/Risk Estimates

There is the potential for post-application exposure for individuals exposed as a result of being in 

an environment that has been previously treated with fluxapyroxad. The quantitative 

exposure/risk assessment for residential post-application exposures is based on the following 

scenarios: 

1. Hand to Mouth

2. Object to Mouth

3. Incidental Soil Ingestion

The lifestages selected for each post-application scenario are based on an analysis provided as an 

Appendix in the 2012 Residential SOPs5. These lifestages are not the only lifestages that could 

be potentially exposed for these post-application scenarios; however, the assessment of these 

lifestages is health protective for the exposures and risk estimates for any other potentially 

exposed lifestages.

Residential Post-application Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

post-application risk assessment. Each assumption and factor is detailed in the 2012 Residential 

SOPs5.

Residential Post-application Non-Cancer Exposure and Risk Equations

The algorithms used to estimate residential post-application exposure and dose can be found in 

Appendix A and/or the 2012 Residential SOPs5.

Summary of Residential Post-application Non-Cancer Exposure and Risk Estimates

Residential estimated risks far exceed the level of concern (LOC) of 100, and are, therefore, not 

of concern. A summary of the residential post-application exposures and risks are provided 

below in Table 5.

Table 5. Residential Post-application Non-cancer Exposure and Risk Estimates for 

Fluzapyroxad.

Lifestage

Post-application Exposure Scenario Application 

Rate

1

(lb ai/acre)

Dose 

(mg/kg/day)2 MOEs3

Use Site Route of Exposure

Adult

Turf/Lawns

Inhalation N/A: no dermal endpoint

Child

Hand to Mouth

0.23

0.0035 2,600

Object to Mouth 0.00011 85,000

Incidental Soil 

Ingestion 0.0000078 1,200,000

1. Based on registered or proposed label (Reg. No. 7969-GUO, 7969-GLN).

2. Dose (mg/kg/day) equations: HtM: E = [HR * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)

(Freq_HtM/N-Replen)/BW)]. OtM: E = [OR* CF1 * SAMO * 

(ET * N_Replen) * (1- (1- SEO)

(Freq_OtM/N_Replen)/BW)]. ISI: E = [OR* CF1 * SAMO * (ET * N_Replen) * (1- (1- SEO)(Freq_OtM/N_Replen))/BW]

3. MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day).

 

5 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 16 of 34

It is noted that the 0.23 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children. As this rate is equal to or higher than many of 

agricultural application rates, this scenario is protective of any exposure of farm children via 

spray drift from agricultural fluxapyroxad applications.

5.3 Residential Risk Estimates for Use in Aggregate Assessment

The recommended residential exposure for use in the children 1<2 years old aggregate 

assessment reflects hand-to-mouth exposures from children playing on turf. The residential doses 

to be used for the aggregate risk assessment and the source of those exposures are shown in 

Table 6, below. 

1. Bolded risk estimates should contribute to the residential exposure portion of the aggregate assessment. 

2. Residential Handler Dose = the highest handler dose for each applicable lifestage of all scenarios assessed from Table 5.

3. Residential Handler MOE = the MOEs associated with the highest doses identified in Table 5.

4. Residential Post-application Dose = the highest post-application dose for each applicable lifestage of all scenarios assessed from Table 6. 

5. Residential Post-application MOE = the MOEs associated with the highest doses identified in Table 6

6. Lifestage population was combined (BW = 80) due to an inhalation only assessment with MOEs well above 100.

7. For aggregate exposure, HtM will be used, whereas this scenario is the most conservative.

There are no residential use scenarios that would result in potential intermediate-term exposure 

to fluxapyroxad; therefore, an intermediate-term aggregate risk assessment is not required.

Table 6. Recommendations for the Short- and Intermediate-Term Residential Exposures for the 

Fluxapyroxad Aggregate Assessment 1

Lifestage

Handler Exposure 

(mg/kg/day) 2

Residential 

Handler Total 

Exposure 

(mg/kg/day) 3

Residential 

Handler 

Total MOE 4

Post-application Exposure 

(mg/kg/day) 5

Residential 

Post-application 

Total Exposure 

(mg/kg/day)

Residential 

Postapplication 

MOE Dermal Inhalation Dermal Inhalation Oral 6

Short-Term

Adult 

Male N/A 0.022 0.022 420 N/A N/A N/A N/A N/A

Adult 

Female N/A 0.022 0.022 420 N/A N/A N/A N/A N/A

Child N/A N/A N/A N/A N/A N/A 0.0035 0.0035 2600

Intermediate-Term

Adult 

Male

Adult N/A N/A

Female

Child
Page 17 of 34

5.4 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 [chemical]. 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 information6. 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 risk estimates 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. 

It is noted that the 0.23 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children. As this rate is equal to or higher than many of 

agricultural application rates, this scenario is protective of any exposure of farm children via 

spray drift from agricultural fluxapyroxad applications.

5.5 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 primarily because of the low acute 

inhalation toxicity (Toxicity Category III and IV), low vapor pressure (insert VP), and the low 

proposed use rate (0.xx lb ai/A). However, volatilization of pesticides may be a source of postapplication inhalation exposure to individuals nearby pesticide applications. The Agency sought 

expert advice and input on issues related to volatilization of pesticides from its Federal 

Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, 

and received the SAP’s final report on March 2, 20107. The Agency is in the process of 

evaluating the SAP report and may, as appropriate, develop policies and procedures to identify 

the need for and, subsequently, the way to incorporate post-application inhalation exposure into 

the Agency's risk assessments. If new policies or procedures are developed, the Agency may 

revisit the need for a quantitative post-application inhalation exposure assessment for 

fluxapyroxad.

 

6 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm 

7 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 18 of 34

6.0 Occupational Exposure and Risk Estimates

6.1 Occupational Handler Exposure/Risk Estimates

Occupational handler and post-application exposure scenarios were assessed to support proposed 

crop, turf, and seed treatment uses. Based on the product labels and information provided by the 

registrant, short- and intermediate-term exposure is assessed for occupational handlers and postapplication activities. Chronic exposure is not expected for the proposed use patterns. Only 

inhalation exposures are assessed for proposed new uses of fluxapyroxad. Dermal exposures are 

not assessed because PODs for short- and intermediate-term dermal exposure were not selected 

because fluxapyroxad does not pose a dermal hazard. Labels for fluxapyroxad formulations 

require that mixers, loaders, applicators and other handlers (seed treatment activities) wear longsleeved shirt and long pants, chemical resistant gloves, protective eyewear, and shoes plus socks. 

The quantitative exposure/risk assessment developed for occupational handlers is based on the 

following scenarios: 

Mixing and Loading Scenarios

• Open mixing/loading for aerial application;

• Open mixing/loading for groundboom application;

• Open mixing/loading for airblast application.

• Open mixing/loading for chemigation application.

Application Scenarios

• Applying sprays with aerial equipment;

• Applying sprays with groundboom equipment;

• Applying sprays with airblast equipment;

Mixing/Loading/Applying Scenarios

• Open mixing/loading/applying for manually pressurized handgun application.

Flagging: 

Flagging for liquid aerial applications

Seed Treatment

(Primary Handler – Treating Seed)

Mixing, loading, applying liquid formulations;

Bagging treated seed;

Sewing bags; and

Multiple activities

(Secondary Handler – Planting Seed)

Planting treated seed consists of the farmer purchasing bags of treated seed, placing the seed 

in the hopper and applying seed to fields.
Page 19 of 34

Occupational Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational 

handler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate: 

• Maximum label application rates for aerial, groundboom, chemigation and airblast:

 0.09 – 0.23 lb ai/A

• Maximum label application rates for mechanically pressurized handgun:

1.39 – 2.47 lb ai/gal

• Maximum label application rates for seed treatment:

0.01- 0.25 lb ai/100 lb seed 

Area Treated or Amount Handled:

• Area treated for aerial, groundboom and airblast application: 

1200 acres per day for aerial application to high acreage field crops

350 acres per day for aerial application to typical field crops, grapes, and sod

350 acres per day for chemigation application to typical field crops

80 acres per day for groundboom application to sod and typical field crops

40 acres per day for groundboom application to turf (golf course)

40 acres per day for airblast application to orchards (tree nuts/grapes)

 5 acres per day for groundboom application to turf (golf course tees and greens only)

5 acres per day for mechanically pressurized handgun application to turf (parks, athletic 

 fields, commercial areas)

• Amount (pounds) of Seed Treated per Day (Primary Handler) 

- Brassica vegetables – 3,000

- Bulb vegetables - 3,000

- Cucurbit vegetables - 339,5000

- Leafy vegetables – 3,000

- Rapeseed – 125,000

- Rice – 302,500

- Root/tuber vegetables – 800,000)

• Amount (pounds) of Seed Planted per Day (Secondary Handler)

- Brassica vegetables – 112.45

- Bulb vegetables - 756.88

- Cucurbit vegetables - 614.60

- Leafy vegetables – 4.84

- Rapeseed – 60,550

- Rice – 17,424

- Root/tuber vegetables – 418.18

Amount of Seed Planted Per Day:

The amount of seed planted per day is based on information provided in the HED Reviewer’s 

Aid to Calculating Occupational Exposures from Activities Related to Agricultural Seed 

Treatment (November 29, 2012) and the BEAD Acres Planted per Day and Seeding Rates of 

Crops Grown in the United States,
Page 20 of 34

Seed treatment exposure duration: 

Treatment of the proposed seeds is expected to result in short- and intermediate-term exposure. 

On- Farm seed treatment exposure and risk

HED assumes that the commercial seed treatment risk assessment is protective of on-farm seed 

treatment because the commercial and farm equipment are similar but the on-farm throughput is 

significantly less than in commercial seed treatment.

Exposure Duration: 

HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months 

as intermediate-term.

Unit Exposures:

It is the policy of HED to use the best available data to assess handler exposure. Sources of 

generic handler data, used as surrogate data in the absence of chemical-specific data, include 

PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force (ORETF) 

database, or other registrant-submitted occupational exposure studies. Some of these data are 

proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The 

standard values recommended for use in predicting handler exposure that are used in this 

assessment, known as “unit exposures”, are outlined in the “Occupational Pesticide Handler Unit 

Exposure Surrogate Reference Table8”, which, along with additional information on HED policy 

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

Agency website9.

Absorption

A dermal absorption factor was not used for the exposure assessment. Since no inhalation 

absorption data are available, toxicity by the inhalation route is considered to be equivalent to the 

estimated toxicity by the oral route of exposure.

Body Weight

The standard body weight for the general population (80 kg) was used for all exposure scenarios 

covered in this risk assessment since the endpoints selected were not developmental and/or fetal 

effects.

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate non-cancer exposure and dose for occupational handlers can be 

found in Appendix A.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

HED is not concerned with inhalation margins of exposure (MOEs) which are not less than the 

level of concern (LOC) of 100. All worker exposures are assessed as short- and intermediateterm based on label prescribed uses and expected exposure durations. Exposure and risk 

estimates indicate non-cancer risks are not of concern for occupational handler activities for the 

 

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

9 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html
Page 21 of 34

proposed new uses (MOEs > 100). Summaries of occupational handler exposure and risk 

calculations, assumptions, and results are provided in Tables 7, and 8.

Table 7: 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 Intermed-Term

Inhalation

Mixer/Loader 

Aerial

Fixed Wing

(enclosed 

cockpit)

0.219

Turf (sod farms, golf courses, 

commercial lawns, parks, rec. 

areas, cemeteries)

0.23

350

41,000 33,000

Vegetables:

Berries and small fruits, Bulb, 

Leafy (except Brasica), 

Strawberries

0.18 52,000 42,000

Vegetables:

Brassica leafy, Cucurbit, 

Grapes, Root and tuber (except 

sugar beet). Sorghum and 

Millet

0.09

1200

30,000 25,000

Rice 0.135 20,000 16,000

Groundboom 

(open Cab)

0.219

Sod

0.23

80 180,000 140,000

Turf (sod farms, golf courses, 

commercial lawns, parks, rec. 

areas, cemeteries)

40 360,000 290,000

Vegetables:

Berries and small fruits, Bulb, 

Leafy (except Brasica), grapes, 

and Strawberries

0.18 80 230,000 190,000

Sorghum and Millet 0.09 200 180,000 150,000

Airblast

(open cab)

Orchard

(Tree Nuts)

0.11 40 70,000 600,000

Chemigation

Turf (sod farms, golf courses, 

commercial lawns, parks, rec. 

areas, cemeteries)

0.23 350 41,000 33,000
Page 22 of 34

Table 7: 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 Intermed-Term

Inhalation

Vegetables:

Berries and small fruits, Bulb, 

Leafy (except Brasica), 

Strawberries and Grapes

0.18 52,000 42,000

Sorghum and Millet 0.09 1200 30,000 25,000

Applying 

Aerial

Fixed Wing

(enclosed 

cockpit) 5

0.34

Turf (sod farms, golf courses, 

commercial lawns, parks, rec. 

areas, cemeteries)

0.23

350

Exposure estimates are 

expected to be protected by 

mixer/loader, whereas 

application is conducted 

mechanically while the pilot 

in inside the aircraft. 

Vegetables:

Berries and small fruits, Bulb, 

Leafy (except Brasica), 

Strawberries

0.18

Vegetables:

Brassica leafy, Cucurbit, 

Grapes, Root and tuber (except 

sugar beet).

Sorghum and Millet 0.09

1200

Rice 0.135

Groundboom 

(open Cab) 0.034

Turf (sod farms, golf courses 

"fairways", commercial lawns, 

parks, rec. areas, cemeteries). 

0.23

80

110,000 93,000

Vegetables:

Berries and small fruits, Bulb, 

Leafy (except Brasica), 

Strawberries,

Brassica leafy, Cucurbit, 

Grapes, Root and tuber (except 

sugar beet).

0.18 150,000 120,000

Sorghum and Millet 0.09 200 36,000 29,000
Page 23 of 34

Table 7: 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 Intermed-Term

Inhalation

Airblast

(open cab)

(Chemigation)5

4.71

Orchard

(Grapes and Tree Nuts)

0.18 200 21,000 17,000

Mixing/Loading/Applying

Mechanically 

Pressurized 

Handgun

1.9

Turf (sod farms, golf courses 

"fairways", commercial lawns, 

parks, rec. areas, cemeteries).

0.23 5 330,000 270,000

Flagging 

Aerial

Fixed Wing

(enclosed 

cockpit)

0.35 Sorghum and Millit60.09 1200 19,000 15,000

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).

4

Short-/Intermediate-Term MOE = Inhalation NOAEL (9.0 mg/kg/day or 7.3 mg/kg/day ) / Daily Inhalation Dose). The LOC is 100.

5 Aerial and Chemigation: Groundboom applicator MOEs are protective, whereas areal and chemigation application is done mechanically.

6

Sorghum, and Millit have the most conservative MOEs, therefore representative for Flagging activities.

* Daily Dose (mg/kg/day) was calculated by Unit Exposure * 100 % Inhalation absorption factor * Application rate * Area treated} / 80 kg. {Where: 

inhalation absorption is assumed to be 100%}

Seed treatment (primary and secondary handler) occupational handler estimates are summarized 

below.

Table 8. Short- and Intermediate-Term Primary and Secondary Handler Exposures and Risks for Fluxapyroxad 

Seed Treatment 

Seed Type

Inhal 

UEa

mg/lb

Max App Rateb

lb ai/lb seed

Amt Treatedc

lb seed/day

Inhal Dosed

mg/kg/day

Short-Term 

Inhal MOEe

Intermediate-Term 

Inhal MOEf

Loader/Applicator (No Respirator)

Brassica 

Vegetables 0.00034 0.0004 3,000 0.0000051 1,800,000 1,400,000 

Bulb Vegetables 0.00034 0.0025 3,000 0.000032 280,000 230,000 

Cucurbit 

Vegetables 0.00034 0.0004 339,500 0.00058 16,000 13,000

Leafy Vegetables 0.00034 0.0004 3,000 0.0000051 1,800,000 1,400,000

Rapeseed 0.00034 0.0002 125,000 0.00011 85,000 69,000
Page 24 of 34

Table 8. Short- and Intermediate-Term Primary and Secondary Handler Exposures and Risks for Fluxapyroxad 

Seed Treatment 

Seed Type

Inhal 

UEa

mg/lb

Max App Rateb

lb ai/lb seed

Amt Treatedc

lb seed/day

Inhal Dosed

mg/kg/day

Short-Term 

Inhal MOEe

Intermediate-Term 

Inhal MOEf

Rice 0.00034 0.0005 302,500 0.00064 14,000 11,000

Root and Tuber 0.00034 0.0004 800,000 0.0014 6,600 5,400

Sewer (No Respirator)

Brassica 

Vegetables 0.00023 0.0004 3,000 0.0000035 2,600,000 2,100,000

Bulb Vegetables 0.00023 0.0025 3,000 0.000022 420,000 340,000

Cucurbit 

Vegetables 0.00023 0.0004 339,500 0.00039 23,000 19,000

Leafy Vegetables 0.00023 0.0004 3,000 0.0000035 2,600,000 2,100,000

Rapeseed 0.00023 0.0002 125,000 0.000072 130,000 100,000

Rice 0.00023 0.0005 302,500 0.00043 21,000 17,000

Root and Tuber 0.00023 0.0004 800,000 0.00092 9,800 7,900

Bagger (No Respirator)

Brassica 

Vegetables 0.00016 0.0004 3,000 0.0000024 3,800,000 3,000,000 

Bulb Vegetables 0.00016 0.0025 3,000 0.000015 600,000 490,000 

Cucurbit 

Vegetables 0.00016 0.0004 339,500 0.00027 33,000 27,000

Leafy Vegetables 0.00016 0.0004 3,000 0.0000024 3,800,000 3,000,000

Rapeseed 0.00016 0.0002 125,000 0.00005 180,000 150,000

Rice 0.00016 0.0005 302,500 0.0003 30,000 24,000

Root and Tuber 0.00016 0.0004 800,000 0.00064 14,000 11,000

Multiple Activities (No Respirator)

Brassica 

Vegetables 0.0016 0.0004 3,000 0.000024 380,000 300,000

Bulb Vegetables 0.0016 0.0025 3,000 0.0015 60,000 49,000 

Cucurbit 

Vegetables 0.0016 0.0004 339,500 0.0027 3,300 2,700

Leafy Vegetables 0.0016 0.0004 3,000 0.000024 380,000 300,000

Rapeseed 0.0016 0.0002 125,000 0.0005 18,000 15,000

Rice 0.0005 302,500 0.003 3,000 2,400

Root and Tuber 0.0016 0.0004 800,000 0.0064 1,400 1,100

Planters

Brassica 

Vegetables 0.0034 0.0004 112.45 0.000000024 56,000,000 45,000,000

Bulb Vegetables 0.0034 0.0025 756.88 0.000001 60,000,000 49,000

Cucurbit 

Vegetables 0.0034 0.0004 614.60 0.00000013 69,000,000 56,000,000

Leafy Vegetables 0.0034 0.0004 4.84 0.000000001 8,800,000,000 7,100,000,000

Rapeseed 0.0034 0.0002 60,550 0.000016 560,000 450,000

Rice 0.0005 17,424 0.0000019 4,900,000 3,900,000
Page 25 of 34

Table 8. Short- and Intermediate-Term Primary and Secondary Handler Exposures and Risks for Fluxapyroxad 

Seed Treatment 

Seed Type

Inhal 

UEa

mg/lb

Max App Rateb

lb ai/lb seed

Amt Treatedc

lb seed/day

Inhal Dosed

mg/kg/day

Short-Term 

Inhal MOEe

Intermediate-Term 

Inhal MOEf

Root and Tuber 0.0034 0.0004 418.18 0.000000089 100,000,000 82,000,000

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, and Acres planted per day and 

seeding rates of crops grown in the United States (3/24/2011)

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 (80 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.

The Agency matches quantitative occupational exposure assessment with appropriate 

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

flaggers where appropriate, agricultural aviation has changed dramatically over the past two 

decades. According the 2012 National Agricultural Aviation Association (NAAA) survey of 

their membership, the use of GPS for swath guidance in agricultural aviation has grown steadily 

from the mid 1990’s. Over the same time period, the use of human flaggers for aerial pesticide 

applications has decreased steadily from ~15% in the late 1990’s to only 1% in the most recent 

(2012) NAAA survey. The Agency will continue to monitor all available information sources to 

best assess and characterize the exposure potential for human flaggers in agricultural aerial 

applications.

HED has no data to assess exposures to pilots using open cockpits. The only data available is for 

exposure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the 

engineering control (enclosed cockpits) and baseline attire (long-sleeve shirt, long pants, shoes, 

and socks); per the Agency’s Worker Protection Standard stipulations for engineering controls, 

pilots are not required to wear protective gloves for the duration of the application. With this 

level of protection, there are no risk estimates of concern for applicators.

6.2 Occupational Post-application Exposure/Risk Estimates

Occupational post-application dermal exposure was not assessed for fluxapyroxad, since 

fluxapyroxad does not pose a dermal risk. Based on the Agency's current practices, a 

quantitative occupational post-application inhalation exposure assessment was not performed for 

fluxapyroxad at this time. However, an inhalation exposure assessment was performed for 

occupational handlers and this assessment resulted in risk estimates that did not exceed HED’s 

level of concern at baseline inhalation PPE. Since handler exposure resulting from application of 

pesticides outdoors is likely to result in higher exposure than post-application exposure; these 

handler inhalation exposure estimates would be protective of most occupational post-application 

inhalation exposure scenarios. 

The potential for post-application 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 
Page 26 of 34

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 postapplication assessment is required for exposure to treated seeds that have already been planted.

6.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates

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

assessment was not performed for fluxapyroxad at this time primarily because of the low acute 

inhalation toxicity (Toxicity Category III and IV), low vapor pressure (insert VP), and the low 

proposed use rate. 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 resuspension of dusts and/or particulates 

that contain pesticides. The Agency sought expert advice and input on issues related to 

volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on 

March 2, 201010. The Agency is in the process of evaluating the SAP report as well as available 

post-application inhalation exposure data generated by the ARTF 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.

A 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.

Restricted Entry Interval

Short- and intermediate-term post-application risk estimates were not a concern on day 0 (12 

hours following application) for all post-application activities. Under 40 CFR 156.208 (c) (2) 

(iii), ai’s classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation 

are assigned a 12-hour REI. Therefore, the [156 subpart K] Worker Protection Statement interim 

REI of 12 hours is adequate to protect agricultural workers from post-application exposures to 

fluxapyroxad. 

 

10 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 27 of 34

Appendix A. Summary of Occupational and Residential Non-cancer Algorithms

1) RESIDENTIAL

Residential Non-cancer Handler Algorithms

Dermal and Inhalation Handler Exposure Algorithm:

Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, for a given 

formulation-application method combination, is estimated by multiplying the formulationapplication method-specific unit exposure by an estimate of the amount of active ingredient 

handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day);

UE = unit exposure (mg/lb ai);

AR = application rate (e.g., lb ai/ft2, lb ai/gal); and

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

Residential Non-cancer Dose Calculations

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

as:

D = E *AF / BW

where:

D = dose (mg/kg-day);

E = exposure (mg/day);

AF = absorption factor (dermal and/or inhalation); and

BW = body weight (kg).

Residential Non-cancer Post-application Algorithms

Post-application Dermal Exposure Algorithm – Physical Activities on Turf

Exposure resulting from contacting previously treated turf while performing physical activities is 

calculated as shown below. Residential post-application exposure assessment must include 

calculation of exposure on the day of application. Therefore, though an assessment can present 

exposures for any day “t” following the application, it must include “day 0” exposure.

E = TTRt * CF1 * TC * ET
Page 28 of 34

where:

E = exposure (mg/day);

TTRt = turf transferable residue on day t (μg/cm2);

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

TC = transfer coefficient (cm2/hr); and

ET = exposure time (hr/day).

Dermal absorbed doses are calculated as:

BW

E AF D*

where:

D = dose (mg/kg-day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A-X: Turf (Physical Activities) -- Inputs for Residential Post-application Dermal Exposure

Algorithm Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) [input]

F

Fraction of AR as TTR 

following application (if 

chemical-specific data is 

unavailable)

L/WP/WDG 0.01

Granules 0.002

FD

Daily residue dissipation 

(if chemical-specific data 

is unavailable)

(fraction)

L/WP/WDG 0.1

Granules 0.1

TC

Transfer 

Coefficient 

(cm2/hr)

L/WP/WDG

Adults 180,000

Children 1 < 2 years old 49,000

Granules

Adults 200,000

Children 1 < 2 years old 54,000

ET Exposure Time

(hours per day)

Adults 1.5

Children 1 < 2 years old 1.5

BW Body Weight

(kg)

Adults 80

Children 1 < 2 years old 11

L/WP/WDG = Liquids/Wettable Powders/Water-dispersible Granules

Post-application Hand-to-Mouth Exposure Algorithm– Physical Activities on Turf

Exposure from hand-to-mouth activity is calculated as follows (based on the algorithm utilized in 

the SHEDS-Multimedia model):

E = [HR * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)

(Freq_HtM/N-Replen))]
Page 29 of 34

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

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

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

ET = exposure time (hr/day);

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

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

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

and

SA * 2

Fai *DE

HR

H

hands

where:

HR = hand residue loading (mg/cm2);

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

study (unitless);

DE = dermal exposure (mg); and

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

Dose, normalized to body weight, is calculated as:

BW

E

D

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A-X: Turf (Physical Activities) – Inputs for Residential Post-application Hand-to-Mouth Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

Faihands

Fraction of ai on hands 

from dermal transfer 

coefficient study

(unitless)

Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SAH

Typical surface area of one hand (cm2), children 1 < 

2 years old 150

AR Application rate

(mass active ingredient per unit area) [input]

HR Residue available on the hands (mg/cm2) Calculated via (DE * Faihands)/SAH
Page 30 of 34

Table A-X: Turf (Physical Activities) – Inputs for Residential Post-application Hand-to-Mouth Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

FM

Fraction hand surface area mouthed

(fraction/event) 0.127

N_Replen Replenishment intervals per hour

(intervals/hr) 4

ET Exposure time 

(hrs/day) 1.5

SE Saliva extraction factor

(unitless) 0.48

Freq_HtM Hand-to-mouth events per hour

(events/hr) 13.9

BW Body Weight

(kg) Children 1 < 2 years old 11

Post-application Object-to-Mouth Exposure Algorithm– Physical Activities on Turf

Exposure from object-to-mouth activity is calculated as follows (based on the algorithm utilized 

in SHEDS-Multimedia):

E = [OR* CF1 * SAMO * (ET * N_Replen) * (1- (1- SEO)

(Freq_OtM/N_Replen))]

where:

E = exposure (mg/day);

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

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

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

ET = exposure time (hr/day);

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

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

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

and

OR = AR * FO * CF2 * CF3

where:

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

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

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

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

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

Dose, normalized to body weight, is calculated as:
Page 31 of 34

BW

E

D

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A-X: Turf (Physical Activities) – Inputs for Residential Post-application Object-to-Mouth Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

AR Application rate (to turf)

(mass active ingredient per unit area) [input]

FO Fraction of AR as OR following application 10.01

SAMO

Surface area of object mouthed 

(cm2/event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SEO

Saliva extraction factor

(fraction) 0.48

ET Exposure time 

(hours per day) 1.5

Freq_OtM Object-to-mouth events per hour (events/hr) 8.8

BW Body Weight (kg) Children 1 < 2 years old 11

1 This SOP assumes that all of the residue on the turf could be transferred to the object (e.g., object residue is 

equal to turf transferable residue).

Post-application Incidental Soil Ingestion Exposure Algorithm– Physical Activities on Turf

Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

where:

E = exposure (mg/day);

SRt = soil residue on day "t" (μg/g);

SIgR = ingestion rate of soil (mg/day); and

CF1 = weight unit conversion factor (1 x 10-6g/μg).

and

E = SRt * SIgR * CF1

SRt = AR * FS * (1-FD)

t

* CF2 * CF3 * CF4

where:
Page 32 of 34

SRt = soil residue on day "t" (μg/g);

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

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

FD = fraction of residue that dissipates daily (unitless);

T = post-application day on which exposure is being assessed;

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

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

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

Dose, normalized to body weight, are calculated as:

BW

E

D

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A-X: Turf (Physical Activities) – Inputs for Residential Post-application Incidental Soil Ingestion 

Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) [input]

FS Fraction of AR available in uppermost 1 cm of soil

(unitless) 1

FD

Daily residue dissipation

(fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50

BW Body weight (kg) Children 1 < 2 years old 11

2) OCCUPATIONAL EXPOSURE

Occupational Non-cancer Handler Algorithms

Potential daily exposures for occupational handlers are calculated using the following formulas:

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

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

A = area treated or amount handled (e.g., A/day, gal/day).
Page 33 of 34

The daily doses are calculated using the following formula:

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each application handler scenario are 

calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to 

the daily dose of concern. The daily dermal and inhalation dose received by occupational 

handlers are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational 

handlers for each exposure route. All MOE values are calculated using the following formula:

where:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

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

Occupational Non-cancer Post-application Algorithms

Potential daily exposures for occupational post-application workers are calculated using the 

following formulas:

where:

DFRt = dislodgeable foliage residue on day "t" (μg/cm2),

AR = application rate (lb ai/acre),

F = fraction of ai retained on foliage or 25% (unitless),

D = fraction of residue that dissipates daily or 10% (unitless), and

t = number of days after application day (days).
Page 34 of 34

where:

E = exposure (mg ai/day),

TC = transfer coefficient (cm2/hr),

DFRt = dislodgeable foliar residue on day “t” (μg/cm2), and

ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each scenario are calculated using a Margin 

of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. 

The daily dermal dose received by occupational post-application workers is compared to the 

appropriate POD (i.e., NOAEL) to assess the risk to occupational post-application workers. All 

MOE values are calculated using the following formula:

where:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

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

Occupational Seed Treatment 

See Memorandum: Acres planted per Day and Seeding Rates of Crops Grown in the United 

States (March 24, 2011).

See Memorandum: Reviewer’s Aid to Calculating Occupational Exposures from Activities 

Related to Agricultural Seed Treatment (November 29, 2012).

See Memorandum: Seed Treatment Standard Operating Procedure #14