Page 3 of 19

1.0 EXECUTIVE SUMMARY

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

exposure and risk from the use of propiconazole during seed piece dip on sugarcane and aerial; 

chemigation; and groundboom activities on cereal grains. No risks of concern for mixers/loaders, 

applicators, and flaggers were noted. However, 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 revisions. 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]-1H-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 

ground 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 handwand, 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®Fungicide (EPA Reg. No. 100-617) and 

Quilt Xcel®Fungicide (EPA Reg. No. 100-1324). A 7 day PHI is proposed for forage and hay. 

Residential exposures are not expected 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 Agency'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 current assessment of aerial, groundboom, and 

chemigation applications 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. 

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 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). 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 involved in hand weeding; scouting; 

thinning; hand harvesting; irrigation. 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 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.

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 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).

Human Studies Review

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

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

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

database; the ARTF database; ExpoSAC Policy 14 (SOPs for Seed Treatment); the Residential 
Page 5 of 19

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

published literature study, etc], are (1) subject to ethics review pursuant to 40 CFR 26, (2) have 

received that review, and (3) are compliant with applicable ethics requirements. For certain 

studies, the ethics review may have included review by the Human Studies Review Board. 

Descriptions of data sources, as well as guidance on their use, can be found at 

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

The 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 requirements 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 memorandum completed in 

December, 2005 (TXR 0053960, A. Khasawinah). The body weight of 80 kg (combined adults) 

was used for all calculations 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) and is a dermal sensitizer. 

Occupational Dermal, Inhalation, and Incidental Oral Exposure (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 summary of the endpoint selection and acute toxicity 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

UFA= 10x

UFH=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

UFA= 10x

UFH=10x

Residential LOC 

for MOE = 100

Occupational 

LOC for MOE = 

100

24 Month Oncogenicity Study - Mice

LOAEL = 50 mg/kg/day based on nonneoplastic liver effects (increased liver weight 

in males and increase in liver lesions: 

masses/raised areas/ swellings/nodular areas 

mainly).

Dermal 

Short- Term

(1-30 days)

NOAEL= 30 

mg/kg/day

Dermal 

Absorption 

Factor = 40%

UFA= 10x

UFH=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 

IntermediateTerm 

(1-6 months)

NOAEL= 10 

mg/kg/day

Dermal 

Absorption 

Factor = 40%

UFA= 10x

UFH=10x

Residential LOC 

for MOE = 100

Occupational 

LOC for MOE = 

100

24 Month Oncogenicity Study - Mice

LOAEL = 50 mg/kg/day based on nonneoplastic liver effects (increased liver weight 

in males and increase in liver lesions: 

masses/raised areas/ swellings/nodular areas 

mainly).

Inhalation 

Short-Term (1-30 

days)

NOAEL= 30 

mg/kg/day

UFA= 10x

UFH=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 

IntermediateTerm

(1-6 months)

NOAEL= 10 

mg/kg/day

24 Month Oncogenicity Study - Mice

LOAEL = 50 mg/kg/day based on nonneoplastic 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, . UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the 

human population (intra-species) . UFDB = 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 concern
Page 7 of 19

Table 2: Propiconazole Acute Toxicity Profile

Guideline

No. Study Type MRID # Results Toxicity Category

81-1 Acute Oral - rat 00058591 LD50 =1517 mg/kg III

81-2 Acute Dermal-rabbit 00058596 LD50 = >4000 mg/kg III

81-3 Acute Inhalation - rat 41594801 LC50 = >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 proposed 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 chemigation 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 the 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

Occupational handler exposure scenarios were assessed for 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) with 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 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 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 applications;

APPLICATORS

1. Applying sprays with aerial equipment;

 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), the 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 Reference Table” (http://www.epa.gov/opp00001/science/handler-exposuretable.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:

1200 acres for mixing/loading to support aerial applications,

350 acres for mixing /loading chemigation applications

200 acres for mixing/loading to support groundboom applications,

1200 acres for applying with aerial equipment,

200 acres for applying with groundboom 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 Factors

The 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 long 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 amount 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 of 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 

calculated 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

(μg/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

0.175

1,200

220 0.219 37.6 0.219

0.23 0.00057 0.039 0.00057 130 750 43 250

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 2,300
Page 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

(μg/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) LOCf = 100

Aerial

(Enclosed

Cockpit)

0.175

1,200 No Data

5

(Eng. 

Control)

0.068

(Eng. 

Control)

No Data

0.0053

(Eng. 

Control)

0.0002

(Eng. 

Control)

No Data

5,500

(Eng. 

Control)

No 

Data

1,800

(Eng. 

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

(Eng. 

Control)

0.068

(Eng. 

Control)

No Data

0.00098

(Eng. 

Control)

0.0001

(Eng. 

Control)

No Data 8,500 No 

Data

2,800

(Eng. 

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 5,200
Page 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

(μg/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 0.175 350 11 35 12 35 0.0034 0.00028 0.0037 0.00027 8,200 7,600 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 03/12, and located at http://www.epa.gov/opp00001/science/handlerexposure-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, therefore 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 postapplication 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, known 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-appexposure-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 425640-03; 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: AG-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 990046: 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-application propiconazole residues are expected for individuals involved in hand weeding; 

scouting; thinning; hand harvesting, and irrigation. For all dermal post-application exposure 

scenarios, risk estimates do not exceed HED’s LOC (Dermal 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 labels. 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/cm2) = dislodgeable foliar residues corresponding to DAT, based on chemical specific data and application rate.

 4. TC (cm2/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 

Exp.Time)] / [(CF: 1000 μg/mg) x (80-kg Body Weight). Short-Term NOAEL = 30 mg/kg/day; Intermediate-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 postapplication activities in previously treated fields. These potential sources include volatilization of 

pesticides and re-suspension of dusts and/or particulates that contain pesticides. The Agency 

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

Table 5. Summary of Estimated Post-Application MOEs for Sugarcane and Cereal Grains

Crop

Application 

Rate

(lb ai/A) 1

DAT2 DFR 3

(μg/cm2)

TC 4

(cm2/hr) Activity 4

MOE5

LOC = 100

ShortTerm

IntermediateTerm

Sugarcane 0.175 0 0.059*

70 Hand 

weeding 18,00,000 6,100,000

1,100 Scouting 1,200,000 390,000

17,600 Hand 

harvesting 73,000 24,000

Cereal 

Grains 0.114 0 0.184**

70

Hand 

Weeding, 

Thinning 

5,800,000 1,900,000

210 Scouting, 1,900,000 650,000

1,100 Scouting, 370,000 120,000

1,900 Irrigation 210,000 72,000
Page 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 appropriate, develop policies and 

procedures, to identify the need for and, subsequently, the way to incorporate occupational postapplication inhalation exposure into the Agency's risk assessments. If new policies or procedures 

are put into place, the Agency may revisit the need for a quantitative 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 exposure 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 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). 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), and 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)

Inhl. Unit 

Exposure 

(ug/lb ai)

Maximum 

Application 

Ratea

(lb ai/ft2)

Or

(lb ai/Acre)

Area 

Treated or 

Amount 

Handled 

Dailyb

Dermal Inhalation Total

Dose 

(mg/kg/day)c MOE d Dose (mg/kg/day)e MOEf MOEg

Mixer/loader/Applicator

Low Pressure

Handwand/

Ornamentals

100

63,000 18

5.5 x 10-81,200 ft2

0.000021 1,400,000 5.9 x10-95.1 x 1091.4 x 106

Hose-end

Sprayer/

Ornamentals

58,000 1.4 0.000019 1,600,000 1.2 x 10-96.5 x 1010 1.6 x 106

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/ft2)

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 exposure to individuals nearby to pesticide 

applications. The Agency sought expert advice and input on issues related to volatilization of 

pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 

(SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html) and is in the process of 

evaluating the SAP report. The Agency may, as appropriate, develop policies and procedures to 

identify the need for and, subsequently, the way to incorporate post-application inhalation 
Page 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 case 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 Lead Agencies 

for pesticide regulation and other parties to develop the best spray drift management practices (see 

the Agency’s Spray Drift website for more information at 

(http://www.epa.gov/opp00001/factsheets/spraydrift.htm). On a chemical by chemical basis, the 

Agency is now requiring interim mitigation measures for aerial applications that must be placed on 

product labels/labeling. The Agency has completed its evaluation of the new database submitted 

by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a 

policy on how to appropriately apply the data and the AgDRIFT computer model to its risk 

assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the 

policy is in place, the Agency may impose further refinements in spray drift management practices 

to reduce off-target drift with specific products with significant risks associated with drift.

Although a quantitative residential post-application inhalation exposure assessment was not 

performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation 

exposure assessment was performed for flaggers. This exposure scenario is representative of a 

worse case inhalation (drift) exposure and may be considered protective of most outdoor 

agricultural and commercial post-application inhalation exposure scenarios. 

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 Numbers: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-exposure-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).