### Date :

Subject: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### February 25, 2013 OF FI CE OF CHEMICAL SAFETY
AND POLLUTIO N PREVENTION



### FLUOXASTROBIN. Occupational a nd Residential Exposure Assessment for
the Pr oposed Use of Fluoxa strob in o n Melons (Subgroup 9 -A ) and Sorghum and a Reevaluation of t he Registered Granular Formu la tion for Residential Use o n Ornamentals.

PC Code: 028869

Decision No .: 465774

Petition No.: 2F8047 DP Ba r code: D405369 Reg istration No.: 66330-64 Regulatory Action : Sec t ion 3

Case No.: NA Risk Assessment Type: Occupational/Residential Exposure Assessment

TX R No.: NA CAS No.: 361377-29-9

4 0 CFR : §180.609 MRIDNo .: NA



### From:

Through:

To: Kr istin Rury, Biologist



## · y_ 

# Q ..---r

Risk Assessmen t B r anch 3 "' 

# 0

He alth E ffects Division (7509P)

Barry O'Keefe, ORE Team Leade r 

# /J

.. 0 

# <){p#n

Risk Assessment Branch 3 '

.**-~** 

### H ea l th Effects Division (7509P)



### and

Jeff Evans Bridget Bobowiec**~~** 

### Expos ure Science Adv i sory Committee (ExpoSAC) 

### I HED

Nancy Tsaur, Chemis t, Ris k Assessor
Risk Assessment Branch 3

Health Effe c ts Division (7590P)

and

Heather Garvie/Shaja Joyner

, RM 20 Fungicide Branch

Divis i on (7505 P)

Page I of30

### Introduction

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

exposure and risk assessment for the newly proposed use of fluoxastrobin on melons (subgroup 9A) and sorghum. In add ition, HED is provid i ng a reassessment of the registered residential

handler use of granular fluoxastrob i n on ornamentals (EPA Reg. Nos. 66330 -380 and 66330- 

### 407).



### It is HED po l icy to use the best available data to assess exposure. Several sources of generic

data were us e d in this assessment as surrogate data in the absence of chemical-specific data, including Pesticide Handle r s Exposure Database Version 1.1 (PHED 1.1 ), the Agricultural

Handler Exposure Task Force (AHETF) database, the Outdoor Residential Exposure Task Force (ORETF) databa se, the Agricultural Reentry Task Force (ARTF) database, and the Residential

SOPs (Gardens/Trees). Some of the se data are proprietary

, and subject to the data protection provisions of the Federa l Inse cticide, F ungicide, and Rodenticide Act (FIFRA).

Note: This memorandum was reviewed by the Exposure Science Advisory Council (ExpoSAC)

on 02/21/2013.

Page 2 of30Page 3 of 30 

### Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ............. 4
2.0 Risk Assessment Conclusions and Recommendations

................................ ........................ 6
2.1 Summary of Risk Estimates

................................ ................................ ............................. 6
2.2 Label Recommendations

................................ ................................ ................................ .. 6
2.3 Data Deficiencies and Requirements

................................ ................................ ............... 6
3.0 Hazard Characterization

................................ ................................ ................................ ....... 8
4.0 Use Profile

................................ ................................ ................................ ........................... 9
5.0 Residential Exposure and Risk Estimates

................................ ................................ .......... 10
5.1 Residential Handler Exposure/Risk Estimates

................................ ............................... 10
5.2 Residential Post

- application Exposure/Risk Estimates

................................ .................. 11
5.3 Residential Risk Estimates for Use in Aggregate Assessment

................................ ...... 12
5.5 Spray Drift

................................ ................................ ................................ ...................... 13
5.6 Residential Bystander Post

- Application Inhalation Exposure

................................ ....... 13
6.0 Occupational Exposure and Risk Estimates

................................ ................................ ...... 14
6.1 Occupational Handler Exposure/Risk Estimates

................................ ............................ 14
6.2 Occupational Post

- application Exposure/Risk Estimates

................................ .............. 20
6.2.1 Occupational Post

- application Inhalation Exposur e/Risk Estimates

...................... 20
6.2.2 Occupational Post

- application Dermal Exposure/Risk Estimates

.......................... 20 Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

..................... 23Page 4 of 30



### 1.0 Executive Summary

Fluoxastrobin is a strobilurin

- class fungicide (also termed methoxyacrylates) that controls foliar fungal diseases and soilborne/seedling fungal diseases

. It works by interrupting mitochondrial respiration in plant

- pathogenic fungi, thus inhibiting spore germination and mycelial growth.

Arysta LifeScience North America, LLC (Arysta) is proposing a new use of fluoxastrobin on melons (subgroup 9

- A) and sorg hum. The proposed formulated end

- use product is labeled under the trade name Fluoxastrobin 480 SC Fungicide (EPA Reg. No. 66330

- 64) and serves as the master label for EVITO® 480 SC fungicide, DISARMTM 480 SC Fungicide, and Fluoxastrobin 480 SC Fungicide Se ed Treatment. Fluoxastrobin 480 SC Fungicide is a suspension concentrate (SC) formulation containing 40.3% active ingredient (ai) by weight (3.98 lb ai per gallon).

Furthermore, HED reassessed the currently registered use of granular fluoxastrobin on r esidential ornamentals based on current policies and toxicological endpoints because this scenario had not previously been re

- evaluated using HED’s 2012 Residential SOPs and changes for body weight assumptions

.

Proposed Use Profile
Fluoxastrobin 480 SC Fungicide may be applied as a foliar spray via groundboom, aircraft, chemigation, and handheld equipment. The maximum single application rate for melons is 5.7 fl oz/A (0.18 lb ai/A) and applications may be repeated on a 7

- day interval, up to a maximum

se asonal application rate of 22.8 fl oz/A (0.72 lb ai/A) per year. The maximum single application rate for sorghum is 4.0 fl oz/A (0.12 lb ai/A) and applications may be repeated on a

14

- day interval, up to a maximum seasonal application rate of 8 fl oz/A (0 .26 lb ai/A) per year. The proposed label requires occupational handlers to wear long pants, long sleeves, shoes, socks, and chemical resistant gloves.

Exposure Profile Based on application rate and label information, exposure is expected to occur for short

- and
intermediate

- term durations for occupational handlers. Exposure in residential settings is expected to be short

- term only. Chronic exposure is not expected for the proposed use patterns.

Hazard Concerns
A short

- term dermal endpoint was not identified. The estimated intermediate

- term dermal and
th e e stimated short

- and intermediate

- term inhalation exposures were compared to the oral No
Observed Adverse Effec t Level ( NOAEL ) of 3.0 mg/kg/day from a 90 day subchronic dog feeding study. Because this point of departure (POD) is from an oral study, the estimated dermal exposures were adjusted by applying a 2.3% dermal absorption factor. Since inhalation absorptio n data are not available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure. This endpoint is not a developmental effect ; therefore, a n 8 0 kg body weight was used in the calculations. The level of concern (LOC) is a margin of exposure (MOE ) of 100 (i.e. an MOE < 100 is of concern)

. Fluoxastrobin is
characterized as “not likel y to be carcinogenic ” to humans.Page 5 of 30



### Residential Exposures and Risk Estimates Existing residential uses of fluoxastrobin were recently reassessed by HED to reflect updates to HED’s 2012 Residential SOPs along with policy changes for body weight assumptions (N. Tsaur, D393846, 05/31/2012 and N. Tsaur, D406106, 10/25/2012)

, except the use of a granular formulation on ornamental plants. There are no registered products that would lead to any residential handler or post

- application risk estimates of concern. Short

- term residential handler (inhalation only) MOEs range from 7,300 to 1

, 1 00,000 for granular fluoxastrobin use on
residential turf. Because there is no short

- term dermal endpoint, and incidental oral post

application exposures are not expected from application to ornamental plants, residential post

application exposure was no t assessed for granular application to ornamentals. However, the

worst

- case post

- application exposure assessments for existing use s on turf have been presented
here for reference

.

Residential Scenarios Recommended for use in Aggregate Assessment
The mo st protective residential exposure risk estimates are included in the aggregate exposure assessment. The recommended residential exposure for use in the adult aggregate risk assessment reflects dermal and inhalation exposure from hand dispersal of granula rs to ornamentals (MOE = 7,300). The recommended residential exposure for use in the children 1<2 years old aggregate assessment reflects hand

- to

- mouth exposures from post

- application exposure to liquid applications to turf (MOE = 390).

Occupational H andler Exposures and Risk Estimates There is potential for short

- and intermediate

- term occupational exposure to fluoxastrobin during handling (e.g. mixing, loading, application). There are no risk estimates of concern at the baseline level of personal pr otective equipment (PPE); all short

- term handler risk estimates ( inhalation only) resulted in MOEs ranging from 3,400 to 7 6,000 ; all intermediate

- term handler risk estimates (dermal + inhalation) resulted in MOEs ranging from 320 to 21,000

.

Occupational Post

- a pplication Exposures and Risk Estimates There is potential for short

- and intermediate

- term occupational exposure during post

- application
activities. There is no short

- term dermal POD selected for fluoxastrobin. There are no
intermediate

- term derma l post

- application risk estimates of concern on day 0 (12 hours after application); all scenarios resulted in MOEs greater than the LOC (100) and ranged from 1,400 to 55,000 on day 0. Based on a quantitative post

- application assessment, the 12

- hour restri cted entry interval (REI) on the proposed label is acceptable for melons (subgroup 9

- A) and sorghum.

Based on the Agency's current practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for fl uoxastrobin 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 fluoxastrobin

.

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 s tudies from
PHED 1.1

, the AHETF database, the Outdoor Residential Expos ure Task Force (ORETF) database, the ARTF database, and the Residential SOPs ( Gardens and Trees ), are (1) subject toPage 6 of 30



### 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 website 1



### .

2.0 Risk Assessment Conclusions and Recommendations

2.1 Summary of Risk Estimates

Reassessment of Registered Granular Use on Ornamentals There are no registered products that would lead to any residential handler or post

- application
risk estimates of concern. Short

- term residential handler (inhalation only) MOEs range from 7,300 to 1

, 1 00,000 for granular fluoxastrobin use on residential turf. Residential post

application exposure was not assessed b ecause there is no short

- term dermal endpoint, and incidental oral post

- application exposures are not expected from application to ornamental plants.

Occupational Handlers There are no risk estimates of concern at the baseline level of personal protective equipment (PPE) . A ll short

- term handler risk estimates (inhalation only) resulted in MOEs ranging from 3,400 to 76,000; all intermediate

- term handler risk estimates (dermal + inhalation) resulted in MOEs ranging from 320 to 21,000.

Occupational Post

-

Application
There is no short

- term dermal POD selected for fluoxastrobin. Based on a quantitative

assessment, t here are no intermediate

- term dermal post

- application risk estimates of concern on day 0 (12 hours after application); all scenarios resulted in MOEs greater than the LOC (100) and ranged from 1,400 to 55,000 on day 0.

2.2 Label Recommendations

There are no l abel recommendations based on the occupational or updated residential exposure

assessments

.

2. 3 Data Deficiencies and Requirements

There are no outstanding data deficiencies or exposure requirements for fluoxastrobin.

HED recently waived the required subchronic inhalation toxicity study for fluoxastrobin (TXR# 0056388). The waiver was granted because: (1) fluoxastrobin has low acute inhalation toxicity and low volatility; (2) the main target organ is the liver following fluoxastrobin exposure; and (3) all occupational inhalation MOEs are > 1,000 using a conservative oral P O D, except for

1 http://www.epa.gov/pesticides/science/handler

- exposure

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

- app

- exposure

- data.htmlPage 7 of 30



### exposure scenarios the Agency considers relatively rare (mixing/loading for granular application to sod and hand dispersal of granular formulations to turf by residenti al handlers).

Residue Data Requirements Turf Transferrable Residue Studies A TTR study is required for fluoxastrobin at this time since the incidental oral hand

- to

- mouth
MOE for small children is less than 1,000 (MOE = 390, LOC = 100) based on default values for the fraction of application rate available for transfer after a liquid application to turf (N. Tsaur, D406106, 10/25/2012).

Dislogeable Foliar Residue (DFR) Studies Following a foliar application, some pesticide residue remai ns on the leaves of the target plant for an individual to contact and remove from the leaf surface resulting in exposure. 2 

### This is represented by a measurement from a standardized sampling method (Iwata, et al., 1977) and is
referred to as DFR. If no stu dy providing DFR measurements is available for a specific pesticide, potential exposure from DFR can be estimated using the application rate and a default value for the fraction of application rate available to be dislodged after a foliar application (F AR 

### )

. In accordance with the updated Part 158 data requirements (2007), one or more DF R stud ies are required when a pesticide has residential or occupational uses t hat could result in post

application dermal exposure. This guidance indicates, however, that OPP may waive the requirement for a DFR study for a specific pesticide if, based on a case

- by

- case estimate of potential exposure calculated using the default F AR 

### , there is an adequate margin of safety for the potential exposures to DFR of the chemical. In such a circumstance, OPP could reasonably determine that the Agency does not need a chemical

- specific DFR study to reach the conclusion that potential exposures to TTR would not pose an unacceptable risk and therefore that the
chemical

- specific DFR study would not be useful in the Agency’s evaluation.

As part of the recent revision to the Health Effects Division’s 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment , HED analyz ed a number of DFR
studies and selected a new default value for the fraction of the application rate available to be dislodged after a foliar application (F AR 

### ). This default value is 25 % and is based on an analysis
of 19 DFR studies where the F AR 

### value ra nged from 2% to 89%. This value is recommended for use in both residential and occupational post

- application assessments. Of the analyzed DF R studies, the maximum F AR 

### value seen was 89% or 3.6 times higher than the default residue
transfer value. Theref

ore, a calculated MOE of approximately 4 times higher than the LOC (i.e., an MOE > 400 if the LOC = 100) using the default dislodged residue value sh ould provide an adequate margin of safety for any potentially higher residues seen in a chemical

- specific D FR study. A DFR study is not required for fluoxastrobin at this time based on default values for the fraction of application rate available for transfer after a foliar application. All intermediate

- term occupational dermal MOE s for post

- application activities are greater than 4 times the LOC

, except for detassling and hand harvesting sweet corn grain on the day of application ( MOE = 220)

. However, detassling and hand harvesting activities for sweet corn would be unlikely to

occ ur on the day of application for a continuous period of 1

- 6 months . In addition, the fluoxastrobin label provides guidance on resistance management, including that weeds are susceptible to strobilurin resistance, so the total number of applications of flu oxastrobin and

2 Described in more detail in http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.htmlPage 8 of 30



### other Group 11 fungicides should be limited and alternated with other fungicides. All other occupational post

- application dermal MOEs are >400. Therefore, a DFR study is not required.

3 .0 Hazard Characterization

The toxicological doses a nd endpoints supporting this label amendment remain unchanged and have been summarized in the previous human health risk assessment (DP 393842 , N. Tsaur, 06/27/2012).

Acute Toxicity

Table 3.1. Acute Toxicity Profile

– Fluoxastrobin (EPA Reg. No. 66330

- 65 )

.

Guideline No. Study Type MRID Results Toxicity Category

870.1100 Acute oral

- rat 45865612 LD 50 > 2000 mg/kg III

870.1200 Acute dermal

- rat 45865613 LD 50 > 2000 mg/kg III

870.1300 Acute inhalation

- rat 45865618 LC 50 = 4.9 mg/L IV

870.2400 Acute eye irritation

- rabbit 45865620 moderate irritant III

870.2500 Acute dermal irritation

- rabbit 45865622 not an irritant IV

870.2600 Skin sensitization

- guinea pig 45865624 not a sensitizer

-



### Toxicological PODs Used for Risk Assessment

Table 3

. 2

. Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary
, Non

Occupational , and Occupational Human Health Risk Assessments a

Exposure/
Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors RfD, PAD,

Level of
Concern for
Risk

Assessment Study and Toxicological Effects

Incidental Oral
Short

- Term (1

- 30 days)
and
Intermediate

Term (1

- 6 months) NOAEL =

3.0 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Residential

LOC for
MOE = 100 90

- day subchronic dog

LOAEL = M/F 24.8/24.2 mg/kg/day based
on dose

- related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular ep ithelium in males).

Dermal Short

Term (1

- 30 days) None: There were no systemic or dermal toxicity findings in a 28

- day dermal toxicity study in

the rat up to the limit dose (1000 mg/kg/day) and there were no developmental or neurotoxicity
concerns raised in other studies.

Dermal
Intermediate

Term (1

- 6 months) NOAEL =

3.0 mg/kg/day

dermal absorption factor =
2.3% UF A = 10X

UF H = 10X FQPA SF = 1X LOC for

MOE = 100 90

- day subchronic dog

LOAEL = M/F 24.8/24.2 mg/kg/day based
on dose

- related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular epithelium in males).Page 9 of 30

Table 3

. 2

. Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary
, Non

Occupational , and Occupational Human Health Risk Assessments a

Exposure/
Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors RfD, PAD,

Level of
Concern for
Risk

Assessment Study and Toxicological Effects

Inhalation
Short

- Term (1

- 30 days)
and
Intermediate

Term (1

- 6 months) NOAEL =

3.0 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X LOC for

MOE = 100 90

- day subchronic dog

LOAEL = M/F 24.8/24.2 mg/kg/day based
on dose

- related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular epithelium in males). Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans.”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapo lation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern.



### Absorption
Since inhalation abso rption data are not available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.

A dermal absorption factor of 2

. 3 % was used for the intermediate

- term dermal exposure

assessment.

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

Table 4 .1. Summary of Proposed Directions for Use of Fluoxastrobin

.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

Rate (fl oz/A) Applic. Rate (lb ai/A) Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations

Melon (Subgroup 9A)

Ground, Aerial. Chemigation,
Handheld Liquid

[66330

- 64]

Contains 3.98 lb ai/gal product 5.7 fl

oz/A 0.18
(0.018 lb ai/gal) 4 0.72 1 There is a minimum interval of 7 days between applications.
Do not apply to Subgroup

9

- A crops in a Greenhouse.
Not approved for use inPage 10 of 30

Table 4 .1. Summary of Proposed Directions for Use of Fluoxastrobin

.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

Rate (fl oz/A) Applic. Rate (lb ai/A) Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations

California.

Sorghum

Ground, Aerial. Chemigation,
Handheld Liquid

[66330

- 64]
Contains 3.98 lb ai/gal product 4.0 fl

oz/A 0.12 2 0.26 21 (grain & stover)

14 (forage) There is a minimum

interval of 14 days between applications
Not approved for use in
California.



### 5 .0 Residential Exposure and Risk Estimates

There are no proposed residential uses at this time; however, there are existing residential uses of granular fluoxastrobin on ornamentals that have been reassessed in this document to reflect updates to HED’s 2012 Residential SOPs 3 

### along with policy changes for body weight assumptions. All other residential uses were reassessed using HED’s 2012 Residential SOPs and updated body weights in the most re cent ORE assessments (N. Tsaur, D393846, 05/31/2012 and N. Tsaur, D406106, 10/25/2012). The revision of residential exposures will impact the human health aggregate risk assessment for fluoxastrobin

.

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. Resi dential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all elements of an application without use of any PPE

.

The quantitative exposure/risk assessment to evaluate the registered uses of granulars on
ornamentals is based on the following scenarios: Applying with a push

- type rotary spreader, Applying with a spoon, Applying with a cup, Applying via Hand dispersal, and Applying with a shaker can.

Residential Handler Exposure Data and Assumptions A series of assump tions and exposure factors served as the basis for completing the residential handler risk assessments. Each assumption and factor is detailed below.

Application Rate : The registered fluoxastrobin labels allow up to 0.0000719 lb ai/ft 2 

### for granular appli cation to ornamental plants.

3 Available: http://www.epa.gov/pesti cides/science/residential

- exposure

- sop.htmlPage 11 of 30



### 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 SOPs 4



### .

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

.

Residential Handler Non

- Cancer Exposure and Risk Estimate Equations The algorithms used to estimate expo sure and dose for residential handlers can be found in Appendix A and/or the 2012 Residential SOPs 5



### .

Combining Exposures/Risk Estimate s: Dermal and inhalation risk estimate s were not combined in this assessment, since the re is no
short

- term dermal POD.

Summary of Residential Handler Non

- Cancer Exposure and Risk Estimates There are no registered products that would lead to any residential handler or post

- application
risk estimates of concern. Short

- term residential handler (inhalation only) MOEs range from 7,300 to 1

, 100 ,000 for granular fluoxastrobin use on residential turf.

Table 5.1. Residential Handler Non

- cancer Exposure and Risk Estimates for Granular Application of
Fluoxastroin to Ornamentals

.

Exposure Scenario Level of Concern Inhalation
Unit Exposure (mg/lb ai) Maximum

Application
Rate (lb
ai/ft 2 ) 1 Area Treated

or Amount Handled Daily (ft 2 ) 2 Inhalation

Dose (mg/kg/day) 3 MOE 4

Mixer/Loader/Applicator

Applying with Push

- type Rotary Spreader

100 0.0026

0.00007 1 9 1200 0.0000028 1,100,000

Applying with a Spoon 0.087 0.000094 32,000

Applying with a Cup 0.013 0.000014 210,000

Hand Dispersal 0.38 0.00041 7,300

Applying with a Shaker
Can 0.013 0.000014 210,000

1 Based on registered label (EPA Reg. No. 66330

- 380 ).

2 Based on HED’s 2012 Residential SOPs ( http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html ).
3 Inhalation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/ ft 2 ) × Area Treated or Amount Handled ( ft 2 /day ) ÷ BW ( 80 kg).

4 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).



### 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 fluoxastrobin. A quantitative post

application exposure assessment for granular application to orname ntals has not been included

4 Available: http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html

5 Available: http://www.epa.gov/pesticides/science/residential

- exposure

- sop.htmlPage 12 of 30



### because of the following reasons: (1) there is no short

- term dermal POD for fluoxastrobin, (2)
intermediate

- term post

- application is not expected in residential settings, and (3) incidental oral ingestion is not expected from ap plications to ornamentals.

Since fluoxastrobin is also registered for use on turf, all other residential uses were reassessed using HED’s 2012 Residential SOPs and updated body weights in the most recent ORE assessments (N. Tsaur, D393846, 05/31/2012 an d N. Tsaur, D406106, 10/25/2012).

Table 5.2 presents the worst

- case post

- application incidental oral MOE values calculated after liquid applications of fluoxastrobin to turf for all registered products . Post

- application risk
estimates for all scenarios are not of concern to HED ( MOEs range from 390 to 180,000)

. The algorithms used to estimate residential post

- application exposure and dose can be found in Appendix A and/or the 2012 Residential SOPs 6 

### Error! Bookmark not defined.

.

Table 5

. 2. Short

- Term Residential Post

- Application Exposure and Risk Estimates for Fluoxastrobin on Turf.

Lifestage Post

- Application Exposure Scenario Dose 1 MOEs 2 mg/kg/day Suspension Concentrate (SC) Liquid Formulation Fluoxastrobin 480 SC Fungicide (EPA Reg. No. 66330

- 64)

3.69 lb ai/gallon Max Single Application Rate: 2.13 lb ai/A From: N. Tsaur, D406106, 10/25/2012

Child 1 to < 2 year old Hand to Mouth 0.0077 390
Object to Mouth 0.00024 13,000
Incidental Soil Ingestion 0.000017 180,000

1 Hand

- to

- Mouth Dose = hand residue loading (mg/cm 2 ) × fraction of hand mouthed (0.127) × surface area of 1 hand (150 cm 2 )

× exposure time (1.5 hrs/day) × # of replenishment intervals/hr (4 int /hr) × (1

- ((1

- saliva extraction factor (0.5))^(Number of
hand

- to

- mouth events per hour (13.9 events/hr) ÷ # of replenishment intervals/hr)) ÷ body weight (11 kg). Object

- to

- Mouth Dose = object residue loading (μg/cm 2 ) × unit conversion factor (0.001 mg/μg) × object surface area mouthed / event (10 cm 2 /event) × exposure time (1.5 hrs/day) × # replenishment intervals/hr (4 int/hr) × (1

- ((1

- saliva extraction factor (0.50))^(# Object

- to

- Mouth Events/hr (8.8 events/hr) ÷ # replenishment intervals/hr)) ÷ b ody weight (11 kg). Soil Ingestion = soil residue (μg/g) × ingestion rate (50 mg/day) × conversion factor (0.000001 g/μg) ÷ body weight (11 kg). Granule Ingestion = % ai in the product × i ngestion r ate (0.3 g/day) × Conversion Factor (1000 mg/g ) ÷ body w eight ( 11 kg)

. 2 MOE = NOAEL ÷ Daily Dose (mg /kg/day)

. Incidental Oral NOAEL= 3. 0 mg/kg/day . Level of concern = 100.



### 5

. 3 Residential Risk Estimates for Use in Aggregate Assessment

Table 5

. 3 reflects the residential risk estimates that are recommended for use in the aggregate
assessment for fluoxastrobin

. The recommended residential exposure for use in the adult aggregate assessment reflects dermal and inhalation exposure from hand dispersal of granulars to ornamentals in residential settings. The recommended residential exposure for use in the children 1<2 years old aggregate
assessment reflects hand

- to

- mo uth exposures from post

- application exposure fr o m liquid applications to turf.

6 Available: http://www.epa.gov/pesticides/science/residenti al

- exposure

- sop.htmlPage 13 of 30

Table 5.3 . Scenarios Recommended for Aggregate Risk Assessment of Fluoxastrobin (Short

- Term Only )

.

Scenario Daily Dose 1,3 MOE 2,4 mg/kg/day

Adults Residential Handler Inhalation Exposure (Applying Granulars via Hand Dispersal) 0.00041 7,300

Children (1 to <2 Years Old)

Post

- Application Incidental Oral Exposure : Hand

- to

- Mouth

(After Liquid Application to Turf) 0.0 077 390

1 Residential Handler Dose = the highest handler dose for each applicable lifestage of all scenarios assessed from all registered fluoxastrobin
residential uses

– taken from Table 5.1. Total = dermal + inhalation.

2 Residential Handler MOE = the MOEs associated with the highest doses identified in Table 5.1.1.
3 Residential Post

- application Dose = the highest post

- a pplication dose for each applicable lifestage of all scenarios assessed from all registered
fluoxastrobin residential uses

- Table 5.2.

4 Residential Post

- application MOE = the MOEs associated with the highest doses identified in Table 5.2.



### 5

. 5 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 applicatio n method employed for fluoxastrobin

. 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 7



### . 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 as sessments 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 sign ificant 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 assessm ent 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

.

5

. 6 Resid ential Bystander Post

- Application Inhalation Exposure

Based on the Agency's current practices, a quantitative post

- application inhalation exposure assessment was not performed for fluoxastrobin at this time primarily because of the low acute
inhalation to xicity (Toxicity Category IV), low vapor pressure ( 4.2 x 10 - 12 

### mm Hg at 20 °C ), and the low proposed use rate (0. 18 lb ai/A). However, volatilization of pesticides may be a source of post

- application inhalation exposure to individuals nearby pesticide app lications. 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,

7 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htmPage 14 of 30



### and received the SAP’s final report on Ma rch 2, 2010 8



### . 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
fluoxastrobin

.

6 .0 Occupational Exposure and Risk Estimates

6 .1 Occupational 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 job functions or tasks related to applications and exposures can vary depending o n the specifics of each task. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure levels to differ in a manner specific to each application event.

Based on the anticipated use patterns and current labeling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed uses. The quantitative exposure/risk assessment developed for occupatio nal handlers is based on the following scenarios: Mixing/L oading liquids for aerial , chemigation, and groundboom application Applying l iquids with aerial and groundboom equipment, and Mixing/L oading/ A pplying with a mechanically pressurized handgun.

Occup ational 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 : All proposed application rates are provided in Table 4.1.

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 protectio n 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 Table 9 

### ”, 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 website 10



### .

8 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html

9 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pdf

10 Available: http://www.epa.gov/pesticides/science/handler

- exposure

- data.htmlPage 15 of 30



### Area Treated or Amount Handled : Based on HED ExpoSAC Policy 9.1, the amount treated or
handle d per day was assumed to be: 350 acres for mixing/loading for aerial application to melons (subgroup 9A), 1200 acres for mixing/loading for aerial application to sorghum, 350 acres for mixing/loading for chemigation application to melons and sorghum

, 80 acres for mixing/loading for groundboom application to melons (subgroup 9A), 200 acres for mixing/loading for groundboom application to sorghum, 350 acres for aerial applications, and 1000 gallons for applications using a mechanically pressurized handgu n to melons (subgroup 9

- A).

Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months as intermediate

- term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for
more than a one

- month time frame; however, there may be a large agribusiness and/or commercial applicators who may apply a product over a period of weeks (e.g., completing multiple applications for multiple clients within a region).

For fluoxastrobin, based on the proposed use, short

- and intermediate

- term exposure(s) are expected because repeated applications may be made to the proposed crops (up to 4 applications per season). Additionally, since the same POD was selected for both short

- and intermediate

term inhalation exposures, the quantitative occupational exposure assessment is protective of both exposure durations. There was no short

- term dermal POD selected for fluoxastrobin; therefore, only intermediate

- term dermal exposure was quantitatively assessed.

Mitigation/Personal Protective Equipment: Estimates of dermal and inhalation exposure were calculated for various levels of PPE. Results are presented for “baseline,” defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and no respirator, as well as baseline with various levels of PPE as necessary (e.g., gloves, respirator, etc). The fluoxastrobin product labels direct mixers, loaders, applicators and
other handlers to wear long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves.

HED recommends that RD ensure the appropriate safety directions and re

- entry restrictions are
included in the label.

Occupational Handler Non

- Cancer Exposure and Risk Estimate Equations The algorithms used to estimate non

- can cer exposure and dose for occupational handlers can be found in Appendix A

.

Combining Exposures/Risk Estimates: Only inhalation exposure was assessed for short

- term durations because no short

- term dermal
POD was selected for fluoxastrobin. Intermediate

- t erm d ermal and inhalation risk estimates were combined in this assessment, since the toxicological effects for these exposure routes werePage 16 of 30



### the same

. Intermediate

- term d ermal and inhalation risk estimates were combined using the following formula:

Total MOE = Point of Departure (mg/kg/day) ÷ Combined dermal + inhalation dose (mg/kg/day)



### Summary of Occupational Handler Non

- Cancer Exposure and Risk Estimates There are no risk estimates of concern at the baseline level of personal protective equipment (PPE); all short

- term handler risk estimates (inhalation only) resulted in MOEs ranging from 3,400 to 76,000; all intermediate

- term handler risk estimates (dermal + inhalation) resulted in MOEs ranging from 320 to 21,000.

The Agency matches quantitative occupational exposure assessment with appropriate characterization of exposure potential. While HED presents quantitative risk estimates for human flaggers where a ppropriate, 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 stea dily 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 a vailable 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 pilo ts 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 engineer ing 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.

Table 6.1.1. Occupational Handler Short

- Term Non

- Cancer Exposure and Risk Estimates for Fluoxastrobin

.

Exposure Scenario Crop or Target Inhalation Unit Exposure ( μ g/lb ai) 1 Maximum

Application

Rate 2 Area

Treated or
Amount

Handled Daily 3 Inhalation

Baseline (No Respirator) Dose (mg/kg/day) 4 MOE 5

Mixer/Loader

Mixing/Loading for Aerial Application Melon (subgroup 9A) 0.219 0.18 lb ai/A 350 0.000173 17,000

Sorghum 0.219 0.12 lb ai/A 1200 0.000394 7,600

Mixing/Loading for Chemigation Application Melon (subgroup 9A) 0.219 0.18 lb ai/A 350 0.000173 17,000

Sorghum 0.219 0.12 lb ai/A 350 0.000115 26,000

Mixing/Loading for
Groundboom Application Melon (subgroup 9A) 0.219 0.18 lb ai/A 80 0.0000394 76,000

Sorghum 0.219 0.12 lb ai/A 200 0.0000658 46,000

ApplicatorPage 17 of 30

Table 6.1.1. Occupational Handler Short

- Term Non

- Cancer Exposure and Risk Estimates for Fluoxastrobin

.

Exposure Scenario Crop or Target Inhalation Unit Exposure ( μ g/lb ai) 1 Maximum

Application

Rate 2 Area

Treated or
Amount
Handled Daily 3 Inhalation

Baseline (No Respirator) Dose (mg/kg/day) 4 MOE 5

Applying with Aerial Equipment Melon (subgroup 9A) 0.068 0.18 lb ai/A 350 0.0000535 56,000

Sorghum 0.068 0.12 lb ai/A 1200 0.000122 25,000

Applying with
Groundboom Melon (subgroup 9A) 0.34 0.18 lb ai/A 80 0.0000613 49,000

Sorghum 0.34 0.12 lb ai/A 200 0.000102 29,000

Flagger

Flagging for Aerial Application Melon (subgroup 9A) 0.35 0.18 lb ai/A 350 0.000276 11,000

Sorghum 0.35 0.12 lb ai/A 350 0.000184 16,000

Mixer/Loader/Applicator

Mixing/Loading/Appl ying for Broadcast Application with Mechanically Pressurized Handgun Melon (subgroup 9A) 3.9 0.018 lb ai/gal 1000 0.000878 3,400

Mixing/Loading/Appl ying for
Drench/Soil/Ground Directed Application with Mechanically Pressurized Handgun Melon (subgroup 9A) 3.9 0.018 lb ai/gal 1000 0.000878 3,400

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( March 2012 ); Level of mitigation: Baseline. Aerial Application is in a closed system at baseline level of PPE.

2 Based on registered or proposed label (Reg. No. 66330

- 6 4 ).
3 Exposure Science Adv isory Council Policy #9.1.
4 Inhalation Dose = Inhalation Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) ÷ BW ( 80 kg).
5 Inhalation MOE = Inhalation NOAEL ( 3.0 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).Page 18 of 30

Table 6 .1. 2

. Occupational Handler Intermediate

- Term Non

- Cancer Exposure and Risk Estimates for Fluoxastrobin

.

Exposure Scenario Crop or Target Dermal Unit Exposure ( μ g/lb ai) 1 Inhalation Unit

Exposure ( μ g/lb ai) 1 Maximum

Applicatio

n Rate 2 Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation Total

Mitigation Level Mitigation Level Dose (mg/kg/day) 4 MOE 5 Dose (mg/kg/day) 6 MOE 7 MOE 8

Mixer/Loader

Mixing/Loading for Aerial Application Melon

(subgroup 9A) 220 0.219 0.18 lb ai/A 350 0.0040 750 0.000173 17,000 720

Sorghum 220 0.219 0.12 lb ai/A 1200 0.00911 330 0.000394 7,600 320

Mixing/ Loading for Chemigation Application Melon (subgroup 9A) 220 0.219 0.18 lb ai/A 350 0.0040 750 0.000173 17,000 720

Sorghum 220 0.219 0.12 lb ai/A 350 0.00266 1,100 0.000115 26,000 1,100

Mixing/ Loading for Groundboom Application Melon (subgroup 9A) 220 0.219 0.18 lb ai/A 80 0.000911 3,300 0.0000394 76,000 3,200

Sorghum 220 0.219 0.12 lb ai/A 200 0.00152 2,000 0.0000658 46,000 1,900

Applicator

Applying with Aerial Equipment Melon

(subgroup 9A) 5 0.068 0.18 lb ai/A 350 0.0000905 33,00 0 0.0000535 56,000 21,000

Sorghum 5 0.068 0.12 lb ai/A 1200 0.000207 14,000 0.000122 25,000 9,000

Applying with Groundboom Melon (subgroup 9A) 78.6 0.34 0.18 lb ai/A 80 0.000325 9,200 0.0000613 49,000 7,700

Sorghum 78.6 0.34 0.12 lb ai/A 200 0.00054 5,500 0.000102 29,000 4,600

Flagger

Flagging for Aerial Application Melon

(subgroup 9A) 11 0.35 0.18 lb ai/A 350 0.000199 15,000 0.000276 11,000 6,300

Sorghum 11 0.35 0.12 lb ai/A 350 0.000133 23,000 0.000184 16,000 9,400

Mixer/l oader/Applicator

Mixing/Loading/Applying for Broadcast Application with Mechanically Pressurized Handgun Melon

(subgroup 9A) 1,300 3.9 0.018 lb ai/gal 1,000 gal 0.00673 450 0.000878 3,400 400

Mixing/Loading/Applying for
Drench/Soil/Ground Directed Application with Mechanically Pressurized Melon (subgroup 9A) 1,300 3.9 0.018 lb ai/gal 1,000 gal 0.00673 450 0.000878 3,400 400Page 19 of 30

Table 6 .1. 2

. Occupational Handler Intermediate

- Term Non

- Cancer Exposure and Risk Estimates for Fluoxastrobin

.

Exposure Scenario Crop or Target Dermal Unit Exposure ( μ g/lb ai) 1 Inhalation Unit

Exposure ( μ g/lb ai) 1 Maximum

Applicatio

n Rate 2 Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation Total

Mitigation Level Mitigation Level Dose (mg/kg/day) 4 MOE 5 Dose (mg/kg/day) 6 MOE 7 MOE 8

Handgun

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2012 ); Level of mitigation: Baseline. Aerial Application is in a closed system at baseline level of

PPE.

2 Based on registered or proposed label (Reg. No. 66330

- 64 ).
3 Exposure Science Advisory Council Policy #9.1.

4 Dermal Dose = Dermal Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A or gal/day) × DAF (%) ÷ BW ( 80 kg).
5 Dermal MOE = Dermal NOAEL ( 3.0 mg/kg/day) ÷ Dermal Dose (mg/kg/ day).

6 Inhalation Dose = Inhalation Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 3.0 mg/kg/day) ÷ Inhal ation Dose (mg/kg/day).
8 Total MOE = NOAEL ( 3.0 mg/kg/day) ÷ Dermal Dose + Inhalation Dose.Page 20 of 30



### 6

. 2 Occupational Post

- application Exposure/ Risk Estimates

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 re

entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop produc tion, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depend o n such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and the chemical’s deg radation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post

- application exposure.

6

. 2 .1 Occupational Post

- application Inhalation Exposure/Risk Estimates

Based on the A gency's current practices, a quantitative post

- application inhalation exposure assessment was not performed for fluoxastrobin at this time primarily because of the low acute inhalation toxicity (Toxicity Category IV), low vapor pressure (4.2 x 10 - 12 

### mm Hg at 20 °C), and the low proposed use rate (0.18 lb ai/A). However, there are multiple potential sources of post

application inhalation exposure to individuals performing post

- application activities in previously treated fields. These potential sources inc lude 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 A ct Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 11



### . 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 fluoxastrobin

.

Although a quantitative occupational post

- application inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers. 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 handle r inhalation exposure estimates would be protective of most occupational post

- application inhalation exposure scenarios.

6

. 2 .2 Occupational Post

- application Dermal Exposure/Risk Estimates

Occupational Post

- application Dermal Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational
post

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

11 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/12 0109meeting.htmlPage 21 of 30



### Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months as intermediate

- term. For fluoxastrobin , based on the proposed use, both
short

- and intermediate

- term post

- application exposure s are expected. The use pattern indicates that repeated application s are allowed, and hand

- setting irrigation and scouting may allow for continuous exposure. Additionally, there was no short

- term dermal POD selected for fluoxastrobin; therefore, only intermediate

- term post

- application exposure has been quantitatively ass essed.

Transfer Coefficients : It is the policy of HED to use the best available data to assess post

application exposure. Sources of generic post

- application data, used as surrogate data in the
absence of chemical

- specific data, are derived from ARTF ex posure monitoring studies, and, as proprietary data, are subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting post

- application exposure that are used in this assessment,
known as “transfer coefficients” , are presented in the ExpoSAC Policy 3 12 

### ” which, along with additional information about the ARTF data, can be found at the Agency website 13



### .

Table 6.2.2

. 1. Anticipated Post

- Application Activities and Dermal Transfer Coefficients.

Proposed Crops Policy Crop Group Category Transfer

Coefficients (cm 2 /hr ) Activities

Cantaloupe, Watermelon Vegetables,
Cucurbits 1900 Hand

- Set Irrigation

550 Hand Harvesting, Mechanically Assisted

Harvesting, Turning

230 Transplanting

90 Scouting, Hand Weeding, Hand Pruning, Thinning Fruit

Sorghum Field/row crop, tall 210 Scouting

70 Hand Weeding



### Application Rate: All proposed application rates are provided in Table 4.1.

Exposure Time : The average occupational workday is assumed to be 8 hours.

Dislodgeable Foliar Residues : Chemical

- specific dislodgeable foliar residue data have not been
submitted for fluoxastrobin

. Therefore, this assessment uses HED’s default assumption that 25% of the application is available for transfer on day 0 following the application and the residues dissipate at a rate of 10% each following day.

Occupational Post

- application Non

- Cancer Intermediate

- Term Dermal Exposure and Risk
Estimate Equations

12 Available: http://www.epa.gov/pesticides/science/exposac_policy3.pdf

13 Available: htt p://www.epa.gov/pesticides/science/post

- app

- exposure

- data.htmlPage 22 of 30



### The algorithms used to estimate non

- cancer exposure and dose for occupational post

- application workers can be found in Appendix A

.

Occupational Post

- application Non

- Cancer Intermediate

- Term Dermal Risk Estimates
There are no intermediate

- term dermal post

- application risk estimates of concern on d ay 0 (12 hours after application); all scenarios resulted in MOEs greater than the LOC (100) and ranged from 1,400 to 55,000.

Table 6

. 2 .2.2

. Occupational Post

- application Non

- Cancer Intermediate

- Term Exposure and Risk Estimates
for Fluoxastrobin

.

Crop/Site Activities Transfer Coefficient (cm 2 /hr) DFR/TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3

Intermediate

- term

Cantaloupe,
Watermelon Hand

- Set Irrigation 1900 0.505 0.00221 1,400

Hand Harvesting, Mechanically Assisted Harvesting, Turning 550 0.505 0.000639 4,700

Transplanting 230 0.505 0.000267 11,000
Scouting, Hand Weeding, Hand Pruning, Thinning
Fruit 90 0.505 0.000105 29,000

Sorghum Scouting 210 0.337 0.000163 18,000

Hand Weeding 70 0.337 0.0000543 55,000

1 DFR = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; where F = 0.25 and D = 0.10 per day

. 2 Daily Dermal Dose = [DFR (μg/cm 2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption (%)] BW ( 80 kg).

3 MOE = POD ( mg/kg/day) / Daily Dermal Dose. Daily Dermal Dose = [DFR /TTR (μg/cm 2 ) × TC × 0.001 mg/μg × 8 hrs/day × dermal absorption factor (%) ] BW ( 80 kg)

.



### Restricted Entry Interval The REI specified on the proposed label is based on the acute toxicity of fluoxastrobin

. Fluoxastrobin is classified as Toxicity Category III via the dermal route and Toxicity Category

IV for skin irritation potential. It is not a skin sensitizer. 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 Prote ction Statement interim REI of 12 hours is adequate to protect agricultural workers from post

- application exposures to fluoxastrobin. Therefore, the proposed REI is adequate.Page 23 of 30



### Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

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 b y multiplying the formulation

application 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/ft 2 

### , lb ai/gal); and A = area treated or amount handled (e.g., ft 2 

### /day, gal/day).

Residential Non

- cancer Post

- application Algorithms

Post

- application Dermal Exposure Algorithm

– Physical Activities on Turf Exposure resultin g 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

where:

E = exposure (mg/day); TTRt = turf transferable residue on day t (μg/cm 2 

### ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 

### /hr); and ET = exposure time (hr/day).

If chemical

- specific TTR data are available, then surface residues from the day of application should be used (assume that individuals could be exposed to residues immediately af ter application). However, if data are not available, then TTR t 

### can be calculated using the following
formula:

TTR t 

### = AR * F * (1

- FD) t 

### * CF2 * CF3

where:Page 24 of 30



### TTRt = turf transferable residue on day t (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre) ; F = fraction of ai as transferable residue following application (unitless); 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 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### / cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Dermal absorbed doses are calculated as:

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

F D Daily residue dissipation

(if chemical

- specific data is unavailable) (fraction) L/WP/WDG 0.1

Granules 0.1

TC Transfer

Coefficient (cm 2 /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 * ( F

M 

### * SA H 

### ) * (ET * N_Replen) * (1

- (1

- SE ) (Freq_HtM/N

- Replen) 

### )]Page 25 of 30



### where:

E = exposure (mg/day); HR = hand residue loading (mg/cm 2 

### ); FM = fraction hand surface area mouthed / event (fraction/event); SAH = typical surface area of one hand (cm 2 

### ); 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

where:

HR = hand residue loading (mg/cm 2 

### );
Fai hands 

### = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless); DE = dermal exposure (mg); and
SA H 

### = typical surface area of one hand (cm 2 

### ).

Dose, normalized to body weight, is calculated as:

where:

D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X : Turf (Physical Activities)

– Inputs for Res idential Post

- application Hand

- to

- Mouth Exposure Algorithm
Notation Exposure Factor (units) Point Estimate(s)

Fai hands Fraction of ai on hands

from dermal transfer coefficient study (unitless) Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SA H Typical surface area of one hand (cm 2 ), children 1 < 2 years old 150

AR Application rate

(mass active ingredient per unit area) [input]

HR Residue available on the hands (mg/cm 2 ) Calculated via (DE * Fai hands )/SA HPage 26 of 30

Table A

- X : Turf (Physical Activities)

– Inputs for Res idential Post

- application Hand

- to

- Mouth Exposure Algorithm
Notation Exposure Factor (units) Point Estimate(s)

F M 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 * SAM O 

### * (ET * N_Replen) * (1

- (1

- SE O 

### ) (Freq_OtM/N_Replen) 

### )]

where:

E = exposure (mg/day); OR = chemical residue loading on the object on day “t” (ug/cm 2 

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

### = area of the object surface th at is mouthed (cm 2 

### /event); ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour);
SE O 

### = 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 * F O 

### * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F O 

### = fraction of residue available on the o bject (unitless); CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Dose, normalized to body weight, is calculated as:Page 27 of 30



### 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]

F O Fraction of AR as OR following application 1 0.01

SAM O Surface area of object mouthed (cm 2 /event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O 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 - 6 

### g/μg).

and

SRt = AR * FS * (1

- F D 

### ) t 

### * CF2 * CF3 * CF4

where:

SR t 

### = soil residue on day "t" (μg/g);

AR = application rate (lbs ai/ft 2 

### or lb ai/acre); FS = fraction of ai available in uppermost cm of soil (fraction/cm);

F D 

### = fraction of residue that dissipates daily (unitless); T = post

- application day on which exposure is being assessed;Page 28 of 30



### CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ); and CF4 = soil volume to weight unit conversion factor (0.67 cm 3 

### /g soil).

Dose, normalized to body weight, are calculated as:

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

F D Daily residue dissipation (fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50

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



### Occupational Non

- cancer Handler Algorithms

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

where:

E = e xposure (mg ai/day),

UE = u nit e xposure (μ g ai/ lb ai),

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

A = a rea treated or amount handled (e.g., A/day, gal/day)

.

The daily doses are calculated using the following formula:

whe re:Page 29 of 30



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

E = e xposure (mg ai/day),

AF = absorption fa ctor (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
h andlers a re compared to the appropriate POD ( i.e.

, NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values a re calculated using the following formula:

where:

MOE = m argin of e xposure: value used by HED to represent risk estimates (unitless),
POD = p oint of d eparture (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

- ap plication workers are calculated using the following formulas:

where:

DFR t 

### = dislodgeable foliage residue on day "t" (μg/cm 2 

### ),

AR = a pplication r ate (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)

.

where:

E = e xposure (mg ai/day),
TC = t ransfer coefficient (cm 2 

### /hr),

DFR t 

### = d islodgeable f oliar r esidue on day “t” (μg/cm 2 

### ), and

ET = e xposure t ime (hours/day).Page 30 of 30



### The daily doses are calculated using the following formula:

where:

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

E = e xposure (mg ai/day),

AF = absorption fa ctor (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 a re calculated using the following formula:

where:

MOE = margin of exposure: value used by HED to represent risk estimates (un itless),
POD = point of departure (mg/kg/day), and

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