Page 3 of 19



### 1.0 EXECUTIVE SUMMARY

A previous assessment by HED ( D279301, J. Miller, 8/18/05 ) assessed occupational worker

expo sure and risk from the use of propiconazole during seed piece dip on sugarcane and aerial ; chemigation; and groundboom activities on cereal grains

. N o risks of concern for m ixers/loaders, applicators , and flaggers were noted. H owever
, policy revisions such as updates to the Occupational Pesticide Handler Exposure Data (OPHED) http://www.epa.gov/opp00001/science/handler

- exposure

- data.html (e.g., changes in transfer

coefficients for field workers; unit exposures for handlers; spray drift; worker protection and volatilization of pesticides) have prompted exposure assessment revisi ons. There are no proposed residential uses at this time; however, there are existing residential uses that have been reassessed in this document to reflect updates to HED’s 2012 Residential SOPs ( http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html ), along with policy changes for body weight assumptions. The revision of residential exposures will impact the human health aggregate risk assessment for Propiconazole. Each assumption and factor is detailed in the 2012

Residential SOPs (http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html).

Use Profile Propiconazole 1

- [[2

- (2,4

- dichlorophenyl)

- 4

- propyl

- 1,3

- dioxolan

- 2

- yl]methyl]

- 1 H

- 1,2,4

- triazole) is a systemic triazole

- type fungicide that provides broad spectrum disease control on a variety of

food and non

- food crops. Non

- food uses include use on commercial, public and residential ornamentals, landscapes and turf. Agricultural applications of propiconazole are made using

gr ound or aerial equipment. Propiconazole is applied to non

- food areas by both occupational and residential handlers. Occupational application methods for non

- food uses include , seed piece dip, tree injection, and handheld equipment (i.e., low

- pressure han dwand, handgun sprayer, backpack sprayer). Residential applications are made with handheld equipment.

Proposed New Use The Interregional Research Project No. 4 (IR

- 4) has submitted an application for the registration of products containing propiconazole for foliar use sugarcane . The products are manufactured by Syngenta Crop Protection, Inc. under the trade name Tilt ® 

### Fun gicide (EPA Reg. No. 100

- 617) and Quilt Xcel ® 

### Fungicide (EPA Reg. No. 100

- 1324). A 7 day PHI is proposed for forage and hay

. R esidential exposures are not expe cted based on the proposed uses, however the proposed new use will affect the aggregate exposer , therefore an updated residential exposure assessment was

conducted

. The revision of residential exposures will impact the human health aggregate risk

assessment for Propiconazole

. Each assumption and factor is detailed in the 2012 Residential

SOPs (http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html).

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

- cancer occupational post

- application inhalation exposure assessment was not performed for propiconazole 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 propiconazole

.

Personal Protective Equipment For all labels, directions state that applicators and handlers must wear a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks, chemical resistant gloves

, and protective eyewear.Page 4 of 19



### Hazard Concerns The toxicological endpoints used in the curre nt assessment of aerial , groundboom

, and chemigation application s were taken from the most recent toxicology memorandum completed in December, 2005 ( TXR 0053960, A. Khasawinah ). The body weight of 80 kg (combined adults)

was used for all calculations.

T he short

- term dermal

, inhalation , and incidental oral POD ( NOAEL ) chosen was 30 mg/kg/day

from an Acute Neurotoxicity study in rats , based on clinical signs of toxicity (piloerection in one male, diarrhea in one fem ale, tip toe gait in 3 females).

The intermediate

- term dermal

, inhalation , and incidental oral POD ( NOAEL ) chosen was 10 mg/kg/day from a 24 month Oncogenicity study in mice, based on non

- neoplastic liver effects (increased liver weight in males and increase in liver lesions: masses/raised ar eas/ swellings/nodular areas mainly). Since the dermal and inhalation endpoints are based on similar effects, the doses were combined for a total MOE.

Occupational Handlers Occupational handler exposure is expected for individuals involved in commercial aerial, chemigation, and groundboom exposure scenarios. For all dermal and inhalation exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100; Inhalation LOC = 1000)

with label

- specified PPE and, therefore, are not of concern to HED.

Occupational Post

- Application

Post

- application exposure is expected for individuals involve d in hand weeding ; scouting; thinning; hand harvesting; i rrigation. The dermal risk estimates do not exceed HED’s LOC and, therefore, are not of concern to HED. Based on a quantitative post

- application assessment, the 12

- hour REI on the proposed label is acceptable for sugarcane and cereal grains.

Based on the Agency's c urrent practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for propiconazole 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 propiconazole

.

Residential Exposure There are no proposed residential uses at this time; however, there are existing residential uses that

have been reassessed in this document to reflect u pdates to HED’s 2012 Residential SOPs ( http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html ) , along with policy changes for body weight assumptions. The revis ion of residential exposures will impact the human health aggregate risk assessment for Propiconazole. Each assumption and factor is detailed in the 2012

Residential SOPs (http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html).

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 ResidentialPage 5 of 19



### SOPs (list specific SOP); other registrant

- submitted exposure monitoring studies (list MRID); published literature study, etc] , are (1) subject to ethi cs 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 http://www.epa.gov/pesticides/science/handler

- exposure

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

- app

- exposure

- data.html

.

2.0 HAZARD CHARACTERIZATION

T he toxicology database for propiconazole is adequate for evaluating and characterizing propiconazole toxicity and selecting endpoints for purposes of this risk assessment. An immunotoxicity is study required as part of new 40 CFR Part 158 data requirement s for registration of a pesticide has been submitted and indicates no evidence of immunotoxicity.

The toxicological endpoints used in the current assessment of aerial, groundboom, and chemigation applications were taken from the most recent toxicology mem orandum completed in December, 2005 (TXR 0053960, A. Khasawinah). The body weight of 80 kg (combined adults)

was used for all calculation s with a dermal absorption factor of 40%. Propiconazole is classified as a class “C” Possible human carcinogen

.

Propiconazole has low to moderate toxicity in experimental animals by the oral (Category III), dermal (Category III) and inhalation routes (Category IV), is moderately irritating to the eyes (Category III), minimally irritating to the skin (Category IV) an d is a dermal sensitizer.

Occupational Dermal , Inhalation, and Incidental Oral Exposu re (Short

- Term )

The short

- term dermal, inhalation, and incidental oral POD (NOAEL) chosen was 30 mg/kg/day from an Acute Neurotoxicity study in rats, based on clinical signs of toxicity (piloerection in one male, diarrhea in one female, tip toe gait in 3 females). The occupational level of concern is 100, based on the standard uncertainty factors for intra

- species variation (10X) and inter

- species extrapolation (10X).

Occupational Dermal, Inhalation , and Incidental Oral Exposure ( Intermediate

- Term)

The intermediate

- term dermal, inhalation, and incidental oral POD (NOAEL) chosen was 10 mg/kg/day from a 24 month Oncogenicity study in mice, based on non

- neoplastic liver effects (increased liver weight in males and increase in liver lesions: masses/raised areas/ swellings/nodular areas mainly). The occupational level of concern is 100, based on the standard uncertainty factors for intra

- species variation (10X) and inter

- species extrapolation (10X).

A s ummar y of the endpoint s election and a cute t oxicity profile are presented in tables 1 and 2 respectfully.

.Page 6 of 19 

### Table 1. Summary of Toxicological Doses and Endpoints for Propiconazole 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

Incidental Oral

short

- term NOAEL= 30

mg/kg/day UF A = 10x

UF H =10x Residential LOC

for MOE = 100 Occupational

LOC for MOE =

100 Acute Neurotoxicity Study

- Rats

LOAEL = 100 mg/kg/day based on clinical signs of toxicity (piloerection in one male, diarrhea in one female, tip toe gait in 3

females).

Incidental Oral

Intermediate

- term NOAEL= 10

mg/kg/day UF A = 10x

UF H =10x Residential LOC

for MOE = 100 Occupational

LOC for MOE =

100 24 Month Oncogenicity Study

- Mice

LOAEL = 50 mg/kg/day based on non

neoplastic liver effects (increased liver weight

in males and increase in liver lesions:

masse s/raised areas/ swellings/nodular areas

mainly).

Dermal

Short

- Term (1

- 30 days) NOAEL= 30

mg/kg/day

Dermal Absorption

Factor = 40% UF A = 10x

UF H =10x Residential LOC

for MOE = 100 Occupational

LOC for MOE =

100 Acute Neurotoxicity Study

- Rats

LOAEL = 100 mg/kg/day based on clinical signs of toxicity (piloerection in one male, diarrhea in one female, tip toe gait in 3

females).

Dermal

Intermediate

Term (1

- 6 months) NOAEL= 10

mg/kg/day

Dermal Absorption

Factor = 40% UF A = 10x

UF H =10x Residential LOC

for MOE = 100 Occupational

LOC for MOE =

100 24 Month Oncogenicity Study

- Mice

LOAEL = 50 mg/kg/day based on non

neoplastic liver effects (increased liver weight

in males and increase in liver lesions: masses/raised areas/ swellings/nodular areas

main ly).

Inhalation

Short

- Term (1

- 30 days) NOAEL= 30

mg/kg/day UF A = 10x

UF H =10x Occupational

LOC for MOE =

100 Acute Neurotoxicity Study

- Rats

LOAEL = 100 mg/kg/day based on clinical signs of toxicity (piloerection in one male, diarrhea in one female, tip toe gait in 3

females).

Inhalation

Intermediate

Term (1

- 6 months) NOAEL= 10

mg/kg/day 24 Month Oncogenicity Study

- Mice LOAEL = 50 mg/kg/day based on non

neoplastic liver effects (increased liver weight

in males and increase in liver lesions: masses/raised areas/ swellings/nodular areas

mainly).

Cancer (all routes) Classification: Group C, possible human carcinogen, RfD approach for risk characterization

UF = uncertainty factor, . UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intra

- species) . UF DB = to account for the absence of key date (i.e., lack of a critical study). NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, MOE = margin of exposure, LOC = level of concernPage 7 of 19



### Table 2: Propiconazole Acute Toxicity Profile

Guideline

No. Study Type MRID # Results Toxicity Category

81

- 1 Acute Oral

- rat 00058591 LD 50 

### =1517 mg/kg III

81

- 2 Acute Dermal

- rabbit 00058596 LD 50 

### = >4000 mg/kg III

81

- 3 Acute Inhalation

- rat 41594801 LC 50 

### = >50.84 mg/L IV

81

- 4 Primary Eye Irritation 00058597 Corneal opacity

reversed in 72 hours III

81

- 5 Primary Skin Irritation 00058598 No irritation IV

81

- 6 Dermal Sensitization 00058600 Non sensitizer

-

3.0 PROPOSED USE PATTERNS

Proposed New Use The Interregional Research Project No. 4 (IR

- 4) has submitted an application for the registration of products containing propiconazole for foliar use sugarcane. The products are manufactured by Syngenta Crop Protection, Inc. under the trade name Tilt ® 

### Fungicide (EPA Reg. No. 100

- 617) and Quilt Xcel ® 

### Fungicide (EPA Reg. No. 100

- 1324). A 7 day PHI is prop osed for forage and hay. The maximum application rates specified on the submitted labels (sugarcane = 0.175 lb ai/A); ( cereal grains = 0.114 lb ai/A) and HED standard assumptions for acres treated (1200 for aerial; 350 for aerial/flagger; 350 for chemigat ion and 200 for groundboom applications ), the combined

short

- term and intermediate

- term dermal and inhalation MOEs are not of concern at label specified PPE (long sleeve shirt; long pants; chemical resistant gloves, and protective eyewear). A summary

of t he proposed use profile is presented in Table 3

.

Table 3 . Label Directions for Proposed Uses of Propiconazole

Product EPA

Reg.

No. Use Site Target Application

Methods Maximum

Application

Rate (lb ai/A) PHI

(day) REI (hr) Use Directions/

Limitations

Tilt ®
Fungicide

EC (100

-

617)

Sugarcane Broadcast

Foliar:

Prior to rust development Aerial

Chemigation

Groundboom 0.113

– 0.169

(4 app. / season) 30

45 (Animal Feed) 1 12

hr A minimum

retreatment interval (RTI) of 14 days is proposed.

Quilt

Xcel ®
Fungicide

EC (100

-

1324) 0.128

- 0.175 (4 app. /season) A minimum

retreatment interval (RTI) of 14 days is proposed.

Contains azoxystrobin

also.Page 8 of 19 1. 45 day for animal feed only. 2. 7 day PHI for forage and hay only

.



### 4.0 Occupational Handler Exposure and Risk Estimates

Occupatio nal handler exposure scenarios were assessed fo r the proposed use of propiconazole on sugarcane and cereal grains. For all dermal and inhalation exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100; Inhalation LOC = 100 ) wi th label

- specified PPE and, therefore, are not of concern to HED. Since the dermal and inhalation endpoints are based on similar effects, the doses are combined for a total MOE. See table 3 for details.

HED uses the term handlers to describe those indivi duals 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 on 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 occupational handlers is based on the following scenarios:

MIXER/LOADER

1. Open mixing/loading EC for aerial applications;

2. Open mixing/loading EC for chemigation applications;

3. Open mixing/loading EC for groundboom applicati o ns;

APPLICATORS

1. Applying sprays with ae r ial equipm e nt;
2

. Applying sprays with groundboom equipment ;

Note: Chemigation is an irrigation system that does not have an applicator. It is applied mechanically. Tilt ®
Fungicide

EC (100

-

617) Cereal

Grains: Wheat; Barley; Oats; Rye;

Triticale Broadcast

Foliar Aerial

Chemigation

Groundboom 0.056

- 0.113

(2 app. /season) 14

7 (Forage

and Hay) 2 12

hr A minimum

retreatment interval (RTI) of 14 days is proposed.

Quilt

Xcel ®
Fungicide

EC (100

-

1324) 0.056

- 0.112 (2 app. /season) A minimum

retreatment interval (RTI) of 14 days is proposed.

Contains azoxystrobin

also. Quilt ®
Fungicide

EC (100

-

1178) 0.056

- 0.114 (2 app. /season)Page 9 of 19



### FLAGGERS

1. Flagging for aerial applications ;

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 the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), t he Agricultural Handler Exposure Task Force (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 Refere nce Table” (http://www.epa.gov/opp00001/science/handler

- exposure

table.pdf) , which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at http://www.epa.gov/pesticides/science/handler

- exposure

- data.html

.

Area/Amount Treated Based on HED ExpoSAC Policy No. 9.1, the area treated in a day was assumed to be:

12 0 0 acres for mixing/loading to support aerial applications, 350 acres for mixing /loading chemigation applications

20 0 acres for mixing/loading to support groundboom applications,

12 0 0 acres for applying with aerial equipment,

20 0 acres for applying with gro undboom equipment, and 350 acres for flagging to support aerial applications.

Body Weight The average adult body weight of 80 kg was used for estimating short

- , and intermediate

- term dermal and inhalation daily dose calculations.

Absorption Factor s
T he short

- and intermediate

- term dermal absorption factor is 40%.

Personal Protective Equipment (PPE) For pesticide handlers, this assessment presents “baseline” and “label specific PPE (i.e. workers wearing a single layer of work clothing consisting of a lo ng sleeved shirt, long pants, shoes, plus socks and protective eyewear ) calculations. See table 3 for specifics.

Equations and Calculations

Daily Dose: Daily dose (dermal and inhalation) is calculated by normalizing the daily exposure (dermal or inhalation) value by body weight and accounting for absorption factors:

Average Daily Dose (mg/kg/day) = Daily Exposure (mg ai/day) x { Absorption Factor } Body Weight (kg)Page 10 of 19



### Where:

Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given scenario (mg pesticide active ingredient/kg body weight/day), Daily Exposure = Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amou nt inhaled that is available for inhalation absorption, Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as the skin or lungs, and Body Weight = Body weight determined to represent the population o f interest in a

risk assessment.

Margin of Exposure (MOE): The daily dermal and inhalation dose received by occupational handlers was compared to the appropriate PoD (i.e. NOAELs) to assess the risk to occupational handlers. All MOE values were

calcu lated using the following formula:

MOE = NOAEL (mg/kg/day)

Average Daily Dose (mg/kg/day)

Where:

MOE = Margin of exposure value used by HED to represent risk or how close

a chemical exposure is to being a concern (unitless),

ADD = Average daily dose (ADD) is absorbed dose received from exposure to

pesticide, and

NOAEL = Dose level in a toxicity study, where no observed adverse effects occurred in

the study.

For all dermal and inhalation exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100; Inhalation LOC = 100 ) with label

- specified PPE and, therefore, are not of

concern to HED. Summaries of the combined short

- and intermediate

- term risk estimates for occupational handlers are included in Table 4

.Page 11 of 19 Table 4

. Agricultural Handler Exposure and Risk for Propiconazole Use on Sugarcane and Cereal Grains

Exposure

Scenario Maxium

App. Rate a

(lb ai/A) Area

Treated
Daily b

(acres) Unit Exposure

( μ g/lb ai) c Dose
(mg/kg/day) d MOEs e

Combined

Short

- term Combined

Int.

- term

Baseline
(BL) Baseline +

Label Spec. PPE Baseline
(BL) Baseline +

Label Spec. PPE Dermal +

Inhalation Dermal +

Inhalation

Dermal Inhal. Dermal Inhal. Dermal Inhal. Dermal Inhal. BL BL+

PPE BL BL+

PPE

Mixing/Loading “Sugarcane” (Emulsifiable Concentrate) LOC = 100

Aerial

0.1 75 1,200

220 0.219 37.6 0.219 0.23 0.00057 0.039 0.00057 130 750 4 3 250

Chemigation 350 0.067 0.00017 0.012 0.00017 440 2,600 150 860

Groundboom 200 0.039 0.000096 0.0066 0.000096 780 4,500 260 1,500

Mixing/Loading “Cereal Grains” (Emulsifiable Concentrate) LOC = 100

Aerial

0.114 1,200

220 0.219 37.6 0.219 0.015 0.00037 0.0257 0.00037 200 1,100 66 380

Chemigation 350 0.044 0.00011 0.0075 0.00011 680 3,900 230 1,300

Groundboom 200 0.025 0.000062 0.0043 0.000062 1,200 6,900 400 2,300Page 12 of 19 Table 4

. Agricultural Handler Exposure and Risk for Propiconazole Use on Sugarcane and Cereal Grains

Exposure

Scenario Maxium

App. Rate a

(lb ai/A) Area

Treated
Daily b

(acres) Unit Exposure

( μ g/lb ai) c Dose
(mg/kg/day) d MOEs e

Combined

Short

- term Combined

Int.

- term

Baseline
(BL) Baseline +

Label Spec. PPE Baseline
(BL) Baseline +

Label Spec. PPE Dermal +

Inhalation Dermal +

Inhalation

Dermal Inhal. Dermal Inhal. Dermal Inhal. Dermal Inhal. BL BL+

PPE BL BL+

PPE

Applying “Sugarcane” (Emulsifiable Concentrate) LOC f = 100

Aerial (Enclosed
Cockpit)

0.1 75 1,200 No Data 5

(E ng. Control) 0.068

(E ng. Control) No Data 0.0053

(E ng. Control) 0.0002

(E ng. Control) No Data 5,500

(E ng. Control) No

Data 1,800

(E ng. Control)

Chemigation N/A

Groundboom Equipment (Open Cab) 200 78.6 0.34 16.1 0.34 0.014 0.00015 0.0028 0.00015 2,200 10,000 720 3,400

Applying “

Cereal Grains ” (Emulsifiable Concentrate) LOC = 100

Aerial (Enclosed
Cockpit)

0.114 1,200 No Data 5

(E ng. Control) 0.068

(E ng. Control) No Data 0.00098

(E ng. Control) 0.0001

(E ng. Control) No Data 8,500 No

Data 2,800

(E ng. Control)

Chemigation N/A

Groundboom Equipment (Open Cab) 200 78.6 0.34 16.1 0.34 0.009 0.000097 0.0018 0.000097 3,300 160,000 1,100 5,200Page 13 of 19 Table 4

. Agricultural Handler Exposure and Risk for Propiconazole Use on Sugarcane and Cereal Grains

Exposure

Scenario Maxium

App. Rate a

(lb ai/A) Area

Treated
Daily b

(acres) Unit Exposure

( μ g/lb ai) c Dose
(mg/kg/day) d MOEs e

Combined

Short

- term Combined

Int.

- term

Baseline
(BL) Baseline +

Label Spec. PPE Baseline
(BL) Baseline +

Label Spec. PPE Dermal +

Inhalation Dermal +

Inhalation

Dermal Inhal. Dermal Inhal. Dermal Inhal. Dermal Inhal. BL BL+

PPE BL BL+

PPE

Flagging LOC = 100

Aerial 0.1 75 35 0 11 35 12 35 0.0034 0.00028 0.0037 0.00027 8,2 00 7,6 00 2,700 2,500

a. Application rates = maximum application rates from the parent labels. b. Area treated daily from Science Advisory Council Policy # 9.1. c. Unit Exposures are from the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table,” dated 03 /1 2 , and located at http://www.epa.gov/opp00001/science/handler

expos ure

- table.pdf and (http://www.epa.gov/pesticides/science/handler

- exposure

- data.html)

. d

. Dermal and Inhalation Dose (mg/kg/day) daily unit exposure (μg/lb ai) x application rate (lb ai/acre) x acres treated x 1E

- 3 mg/μg / body weight (80 kg adult).

e. Combined MOE = NOAEL ( 30 mg/kg/day for ST and 10 mg/kg/day for IT) / combined dermal and inhalation daily dose (mg/kg/day). Level of concern = 100. Bold = MOE ≤ 100

. f. LOC = Level Of Concern (target Margin of Exposure or MOE). g. Aerial application rate for Sugarcane (0.175 lb ai/A) is protective of cereal grains, therefor e only flagger for sugarcane was assessed. Aerial : Enclosed Cockpit is an engineering control; therefore the unit exposures and MOEs reflect this

.Page 14 of 19



### 5.0 Occupational Post

- Application Exposure and 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 a re

- entry exposure). Such exposure may occur when workers enter previously treated areas to perform job

functions.

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 Agricultural Reentry Task Force (ARTF) exposure 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, know n as “transfer coefficients”, are presented in the “Science Advisory Council for Exposure (ExpoSAC) Policy 3” (http://www.epa.gov/pesticides/science/exposac_policy3.pdf), which, along with additional information about the ARTF data, can be found at http://www.epa.gov/pesticides/science/post

- app

exposure

- data.html

.



### Post

- application Studies: A total of six studies are described in [memorandum; ( D279301, J. Miller, 8/18/05 )] and listed in this section. These studies described propiconazole residue dissipation and exposure for corn, peaches, rice, pecans, ornamentals and turf.

MRID 42564003: Propiconazole

– Dislodgeable Residue on Corn (North Carolina)

EPA MRID 42 5640

- 03; Report dated 1991. Author Avakian, M; Sponsor: Ciba

- Geigy Corporation Agriculture Division. Submitted by Environmental Technologies Institute, Inc. and EN

- CAS Labs.

MRID 44959701 : Dissipation of Dislodgeable Foliar Residue of Two formulations of Propicoanzole (OrbitTM and OrbitTM 45W) Applied to Peaches. EPA MRID 44959701(0442); Report dated 1999; Author; Rosenheck, L. Report: Lab report Number: 260

- 98: 44580: A G

- 561 Performing Laboratories: ABC Laboratories., Inc.

MRID 45288601: Determination of Transferable Turf Residue on Turf treated with

Banner MAXX ; Report dated (2000); Authors; Rosenheck, L.; Meyer, L. Lab Project

Number 99 0046: 179

- 99. Performing Laboratories: Central California Research Laboratories, Inc.

MRID 40279806 : Author; Honeycutt, R. CGA 64250 (Tilt) Worker Exposure in Pecans Unpublished. Sponsored by: Ciba

- Geigy

MRID 133390 : Author; Honeycutt, R. (1983) CGA 64250 (Tilt) Worker Exposure in Rice: Report No. EIR

- 83011. ( Unpublished study received Dec 12, 1983 under 100

- 617; submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:07222

- C)

MRID 44959702 : Dissipation of Dislodgeable Foliar Residues of Propiconazole (Banner MAXX) ; Applied to Commercial Ornamentals . Rosenheck, L.; Meyer, L.(1999) Final report: Lab Project Number: 1134

- 99. Unpublished study prepared by

Novartis Crop Protection, Inc. 51 p.Page 15 of 19



### HED evaluated these studies and decided that for this occupational post

- application assessment

, the rice study (MRID 133390) DFR values would be used for cereal grains and the corn study (MRID 42564003 ) DFR values would be used for sugarcane.

Post

- appli cation propiconazole residues are expected for individuals involved in hand weeding; scouting; thinning; han d harvesting, and irrigation

. For all dermal post

- application exposure scenarios, risk estimates do not exceed HED’s LOC (D ermal LOC = 100), and therefore not of

concern to HED. The post

- application exposure/risk characterization for sugarcane and cereal grains is summarized in Table 5

.

1. Maximum application rate from proposed label s. See table 2 for specifics. 2. DAT = Days after treatment needed to reach the LOC of 100; DAT 0 = the day of treatment/ assumed to be approx. 12 hours. 3. DFR (μg/cm 2 ) = dislodgeable foliar residues corresponding to DAT, based on chemical specific data and application rate. 4. TC (cm 2 /hr) = transfer coefficients and associated activities from ExpoSAC Policy Number 3

. ( http://www.epa.gov/pesticides/science/exposac_policy3.pdf )

5. MOE on corresponding DAT. MOE = NOAEL / Daily Dose. Daily Dose = [(DFR x TC x 40% Dermal absorption x 8 hr

Ex p. Time)] / [(CF: 1000 μg/mg) x (8 0

- kg Body Weight). Short

- Term NOAEL = 30 mg/kg/day; I ntermediate

- term NOAEL = 1 mg/kg/day. The LOC is 100.

* Sugarcane DFR data (MRID 42564003)

** Cereal Grains DFR data (MRID 133390)



### Post

- Application Inhalation: Based on the Agency's current practices, a quantitative occupational post

- application inhalation exposure assessment was not performed for propiconazole at this time. However, there are multiple potential sources of post

- application inhalation exposure to individuals performing post

application activities in previously treated fields. These potential sources include volatilization of pesticides and re

- suspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and inp ut on issues related to volatilization of pesticides from its Federal Table 5 . Summary of Estimated Post

- A pplica tion MOEs for Sugarcane and Cereal Grains

Crop Application

Rate
(lb ai/A) 1 DAT 2 DFR 3

(μg/cm 2 ) TC 4

(cm 2 /hr) Activity 4 MOE 5

LOC = 100

Short

Term In t ermediate

Term

Sugarcane 0.1 75 0 0. 059 * 70 Hand weeding 18

, 00,000 6, 1 0 0,000

1,100 Scouting 1 ,20 0,000 390 ,000

17,600 Hand

harvesting 73

, 0 00 2 4

, 0 00

Cereal

Grains 0.114 0 0. 184 ** 70 Hand Weeding, Thinning 5

, 8 00,000 1, 9 00,000

210 Scouting, 1, 9 00,000 65 0,000

1,100 Scouting, 37 0,000 120 ,000

1,900 Irrigation 21 0,000 72 ,000Page 16 of 19



### Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report as well as available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force and may, as appropr iate, 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 ma y revisit the need for a quantitative occupational post

- application inhalation exposure assessment for propiconazole

.

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 handler inhalation exposur e estimates would be protective of most occupational post

- application inhalation exposure scenarios.

6.0 Residential (Non

- Occupational) Handler Exposure and Risk Estimates

Residential exposures are not expected based on the proposed uses, however the pro posed new use will affect the aggregate exposer, therefore an updated residential exposure assessment was conducted. The revision of residential exposures will impact the human health aggregate risk assessment for Propiconazole. Each assumption and facto r is detailed in the 2012 Residential

SOPs (http://www.epa.gov/pesticides/science/ residential

- exposure

- sop.html). The residential handler exposure /risk characterization for sugarcane and cereal grains is summarized in Table 6.

For all residential handler exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100), an d therefore not of concern to HED. Summaries of the short

- term risk estimates for

residential handlers are included in Table 6.Page 17 of 19 

### Table 6. Short

- Term Residential Handler Exposure and Risk Estimates for Propiconazole.

Exposure

Scenario Target

MOE Dermal

Unit Exposure (ug/lb ai) In hl. Unit

Exposure (ug/lb ai) Maximum

Application

Rate a

( lb ai/ft 2 )

Or
(lb ai/Acre) Area

Treated or

Amount

Handled Daily b Dermal Inhalation Total

Dose (mg/kg/day) c MOE d Dose (mg/kg/day) e MOE f MOE g



### Mixer/loader/Applicator

Low Pressure

Handwand/

Ornamentals 100 63,000 18

5.5 x 10 - 8 1,200 ft 2 0.000021 1,400,000 5.9 x10 - 9 5.1 x 10 9 1.4 x 10 6

Hose

- end
Sprayer/

Ornamentals 58,000 1.4 0.000019 1,600,000 1.2 x 10 - 9 6.5 x 10 10 1.6 x 10 6

Low Pressure

Handwand/

Turf/Lawns 100 

### Hose

- end Sprayer is protective

Hose

- end Sprayer/

Turf/Lawns 13,400 22 1.8 0.5 Acres 0.060 500 0.000099 300,000 500

Brush/Roller
Applying paint

100 450,000 200

0.0035 lb ai/
1 gal can 0.016 1,900 0.000007 4,300,00 1,900

Airless Sprayer
Applying

Paint 63,000 18 0.0033 9.100 0.00000095 32,000,000 9,100

a. Based on registered or proposed label (0.0024 lb ai/A): [ 0.0024 lb ai/A x A/43,560 sq ft. = 5.5 x 10 - 8 ] or (0.000000055 lb ai/ft 2 )

b. Exposure Science Advisory Council Policy #9.1.

c. Dermal Dose = Dermal 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) x DAF ( 40 %) / BW ( 80 kg).

d. Dermal MOE = Dermal NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day).

e. 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).

f. Inhalation MOE = Inhalation NOAEL (mg/kg /day) / Inhalation Dose (mg/kg/day). Total MOE = NOAEL (mg/kg/day) / (Dermal Dose + Inhalation Dose) OR Total MOE = 1/ [(1/Dermal MOE) + (1/Inhalation MOE)].



### Residential Bystander Post

- Application Inhalation Exposure Based on the Agency's current practices, a quantitative post

- application inhalation exposure assessment was not performed for propiconazole at this time. However, volatilization of pesticides may be a potential source of post

- application inhalation exposu re to individuals nearby to pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ) and is in the process of evaluating the SAP report. The Agency may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate post

- application inhalationPage 18 of 19



### exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative post

- application inhalation exposure assessment for propiconazole

.

Spray Drift Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the c ase with aerial application, but, to a lesser extent, could also be a potential source of exposure from the ground application method employed for Propiconazole . The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State L ead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agency’s Spray Drift website for more information at (http://www.epa.gov/opp00001/factsheets/spraydrift.htm) . On a chemical by chemical b asis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, th e Agency may impose further refinements in spray drift management practices

to reduce off

- target drift with specific products with significant risks associated with drift.

Although a quantitative residential post

- application inhalation exposure assessment was not performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation exposure assessment was performed for flaggers. This exposure scenario is representative of a worse case inhalation (drift) exposure and may be c onsidered protective of most outdoor agricultural and commercial post

- application inhalation exposure scenarios

.

7.0 Residential (Non

- Occupational) Post

- Application Exposure and Risk Estimates

For all residential post

- application exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100), and therefore not of concern to HED. Summaries of the short

- term risk

estimates for residential post

- application activities are included in Table 6.Page 19 of 19

Table 6: Short

- Term Residential Post

- application /Incidental Oral Exposure and Risk Estimates for Propiconazole.

Lifestage Post

- application Exposure Scenario Dose MOEs

Adult

Turf

- sprays Dermal 0.142785 210

Inhalation N/A N/A

Child Dermal 0.282685455 110

Inhalation N/A N/A

Hand to Mouth 0.014490408 2,100

Object to Mouth 0.00044 68,000

Incidental Soil Ingestion 0.000061 490,000



### 8 .0 Conclusion

For all occupational and residential dermal and inhalation exposure scenarios, risk estimates do not exceed HED’s LOC (Dermal LOC = 100; Inhalation LOC = 100 ) and , therefore, are not of concern

to HED.

9.0 References

Label Use Patterns; (EPA Registration Number s : 100

- 671 and 100

- 1324 )

Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( http://www.epa.gov/pesticides/science/handler

- exposure

- table.pdf ) and (http://www.epa.gov/pesticides/science/handler

- exposure

- data.html)

.

Residential Pesticide Handler (http://www.epa.gov/pesticides/science/residential

- e xposure

- sop.html).

End Point Selection; [(Refer to: memorandum December, 2005 ( TXR 0053960, A.

Khasawinah )].

Product description and chemical specific DFR assumptions : [memorandum; (D279301, J. Miller, 8/18/05 ).