2

Propiconazole Preliminary Work Plan – Table of Contents

OVERVIEW ................................................................................................................................... 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY................................................................... 8

CHEMICAL FACTS ...................................................................................................................... 8

USE AND USAGE INFORMATION............................................................................................ 9

RECENT ACTIONS..................................................................................................................... 11

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW.............................. 12

TIMELINE.................................................................................................................................... 15

NEXT STEPS ............................................................................................................................... 15

Appendix – Additional Areas Considered in the Propiconazole Registration Review ............ 16

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Problem Formulation of the Environmental Fate and Ecological Risk in Support of the 

Registration Review of Propiconazole. Carey, Stephen, Abdel-Saheb, Ibrahim, Breithaupt, 

James, Cherry, Daniel, Mostaghimi, Siroos. December 9, 2015.

2. Propiconazole: Human Health Risk Scoping Document in Support of Registration Review. 

Morton, Thurston, O’Rourke, Kelly, Khasawinah, Abdallah, Mottl, Nathan, Tao, Jenny, 

Biswas, Sumitra Bose. December 10, 2015.

3. Tier I (Scoping) Review of Human Incidents and Epidemiology. Evans, Elizabeth, Recore 

Shanna. November 24, 2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Propiconazole (122101).

Chandgoyal, Tara, Prieto, Rafael A. and Smearman, Stephen. October 20, 2015.
3

5. Propiconazole (122101) Screening Level Usage Analysis (SLUA). April 17, 2015.

6. EFED Table 1 Report. July 10, 2015.

7. HED Master Label Report. July 10, 2015.

These and other supporting documents for the propiconazole registration review case may be 

found in the docket EPA-HQ-OPP-2015-0459 at http://www.regulations.gov.
4

OVERVIEW

The docket for propiconazole is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0459). Propiconazole is a systemic 

fungicide registered for use on a number of agricultural, non-agricultural, and antimicrobial sites. 

This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs

knows about propiconazole, highlighting anticipated data and assessment needs, identifying the 

types of information that would be especially useful to the Agency in conducting the review, and

providing an anticipated timeline for completing the registration review for propiconazole. 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about propiconazole and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

propiconazole. The Agency encourages all interested stakeholders to review the PWP and 

Appendix and to provide comments and additional information that will help the Agency’s 

decision-making process for this chemical. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for propiconazole. Next, 

it discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for propiconazole. Finally, the 

Appendix to this document includes identification and discussion of some areas that are 

considered generally in Registration Review along with some additional chemical case-specific 

information.
5

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for propiconazole. For additional discussion 

of the anticipated data needs, see Problem Formulation of the Environmental Fate and 

Ecological Risk in Support of the Registration Review of Propiconazole and Propiconazole: 

Human Health Risk Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the Propiconazole Registration Review

Guideline 

Number

(GLN)1

Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Propiconazole

835.11102,9 Activated sludge sorption isotherm (ASSI) TGAI 12

835.31103,9 Ready biodegradability TGAI 12

835.32204,9 Porous pot test TGAI 12

835.32405,9 Simulation test – aerobic sewage treatment: A. 

activated sludge units TGAI 12

835.32806,9

Simulation tests to assess the primary and 

ultimate biodegradability of chemicals discharged 

to wastewater

TGAI 12

850.10757, 8 Freshwater fish acute toxicity (fathead minnow) TGAI 12

850.14007,8 Estuarine/marine fish early-life stage (ELS) TGAI 12

850.21007 Avian oral toxicity (passerine) TGAI 12

 1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests 

– including renumbering and other designations or changes for some guideline studies. See “Final Test 

Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 2 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0003 . 3 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0017 . The biodegradation study required is based on results of an Activated Sludge Respiration 

Inhibition test

4 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0024 . The biodegradation study required is based on results of an Activated Sludge Respiration 

Inhibition test.

5 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0034 . The biodegradation study required is based on results of an Activated Sludge Respiration 

Inhibition test.

6 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0036 . The biodegradation study required is based on results of an Activated Sludge Respiration 

Inhibition test.

7 These data are anticipated to be required for conventional use sites.

8 Either 850.1075 or 850.1400 will satisfy the data requirement, both studies will not be required. If an acceptable 

freshwater fish acute toxicity study with a fathead minnow (GLN 850.1075) is submitted, an acute to chronic ration 

(ACR) will be calculated in lieu of a saltwater fish ELS study (GLN 850.1400).
6

Table 1: Anticipated Data Needs for the Propiconazole Registration Review

Guideline 

Number

(GLN)1

Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

850.23007 Avian reproduction (mallard duck) TGAI 12

850.3300

or OECD

Test 

Guideline 

2099

Activated sludge respiration inhibition (ASRI) TGAI 12

875.17009 Product use information (paints and stains) TEP 12

875.21007 Turf transferable resides (TTR) TEP 24

875.27009 Product use information (wood preservatives) TEP 12

Non-GLN9 Chronic Freshwater Sediment Testing: (Hyallela 

azteca) (TGAI) TGAI 24

Non-GLN9 Chronic Freshwater Sediment Testing: 

(Chironomus dilutus or C. tentans) TGAI 24

Non-GLN9 Chronic Estuarine/Marine Sediment Testing: 

(Leptocheirus plumulosus) (TGAI) TGAI 24

Non-GLN 

[OECD 

TG 237 

(Tier I)]

7

Honeybee larvae acute oral toxicity TGAI 12

Non-GLN

[OECD 

TG 213 

(Tier I)]

7

Honeybee adult acute oral toxicity TGAI 12

Non-GLN

(Tier I)7 Honeybee adult chronic oral toxicity TGAI 12

Non-GLN 

(Tier I)7 Honeybee larvae chronic oral toxicity TGAI 12

Non-GLN 

(Tier II)7,9

Semi-field testing for pollinators (tunnel or 

colony feeding studies) TEP 24

850.3040 

(Tier III)7, 

10

Field testing for pollinators TEP 24

Non-GLN 

(Tier III)7, 

10

Residues in pollen and nectar/ Field Residue 

Analysis TEP 36

 9 These studies are anticipated to be included in the DCI. However the need for the data will be determined by EPA 

based upon the results of the Tier 1 honey bee laboratory studies.
7

Table 1: Anticipated Data Needs for the Propiconazole Registration Review

Guideline 

Number

(GLN)1

Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Outstanding Data Requirements from Antimicrobial RED GDCI-122101-3112110

Guideline 

Number Study Title Status

875.1100 Dermal Exposure – outdoor

875.1200 Dermal exposure – indoor Data in review.

875.1300 Inhalation exposure – outdoor

875.1400 Inhalation exposure – indoor

 10 GDCI-122101-31121 was issued on September 13, 2011.
8

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of propiconazole. 11

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for propiconazole. 

Table 2: Chemical Facts for Propiconazole

PC code 122101

Case Number 3125

CAS Number 60207-90-1

Year first registered 1981

Pesticide Type Fungicide 

Chemical class Triazole 

Reregistration Eligibility 

Decision (RED)

July 18, 2006

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable. Tolerance reassessment for propiconazole was 

included in the RED. 

 11 http://www2.epa.gov/pesticide-reevaluation
9

Table 2: Chemical Facts for Propiconazole

Cumulative group Not applicable. Propiconazole has not been identified as a 

member of a cumulative group that shares a common mechanism 

of toxicity.

40 CFR Citation Tolerances for the conventional uses of propiconazole are 

established in §180.434. There are no tolerances or tolerance 

exemptions for the antimicrobial uses of propiconazole.

Dual-use Propiconazole is registered for conventional and antimicrobial 

uses. 

Non-pesticidal uses There are no identified non-pesticidal uses of propiconazole. 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Linsey Walsh, walsh.linsey@epa.gov, (703) 347-8030

Registration Division, 

Product Manager

Shaja Joyner, joyner.shaja@epa.gov, (703) 308-3194

Antimicrobials Division, 

Chemical review 

Manager 

Sandra O’Neill, oneill.sandra@epa.gov, (703) 347-0141

Antimicrobials Division, 

Product Manager

Jacquie Hardy, hardy.jacqueline@epa.gov, (703) 308-6416

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for propiconazole. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Propiconazole (122101) in the registration 

review docket for more details.

Table 3: Propiconazole Use and Usage Information

Summary of Use Propiconazole is a systemic fungicide of the triazole (conazoles) 

chemical class that is registered for use on a number of 

agricultural, non-agricultural, and antimicrobial sites. 

Use Sites Conventional Uses

Agricultural: Stone fruit crop group 12, citrus fruits crop group 

10, tree nut group 14, cereal grains group 15, apples, bananas, 

beets, bushberry 13-07B, caneberry 13-07A, dry beans, succulent 

beans (snap), bulb vegetables, carrots, celery, cilantro leaves, 

coriander, corn, cranberry, grasses grown for seed, low growing 

berry 13-07G, mint, mushroom houses-empty, ornamentals, 

parsley, peanuts, pineapple, pistachio, plantain, rapeseed 20A, 

sorghum, soybeans, strawberry, sugar beet, sugarcane, sunflower, 

and tomato.
10

Table 3: Propiconazole Use and Usage Information

Non-Agricultural: Commercial, public and residential ornamental, 

landscapes and turf. 

Antimicrobial Uses 

Propiconazole is registered for use in two major antimicrobial use 

patterns, material preservatives and wood preservatives. Use sites 

for these two categories include the following: adhesives, paints, 

stains, coatings, rubber and plastic products, inks, metalworking 

fluids, lumber, log buildings, roof shingles, wood siding, 

millwork, plywood, wallboard, ceiling tiles, fencing, and 

textiles/canvas.

Summary of Usage Based on private market usage data, the conventional use of 

propiconazole has been increasing since 2004 with a slight 

decrease in use from 2008-2010. 

For years 2009-2013, propiconazole annual usage averaged 

14,000,000 pounds active ingredient (A.I.) treating an annual 

average of 17,000,000 acres, and an overall average application 

rate of 0.084 pounds A.I. per acre. 

Spring and winter wheat are the top crops accounting for 

approximately 50% of propiconazole usage. However, in terms of 

highest percent crop treated (PCT) celery, hazelnuts and pluots 

each account for an average of 55, 45, and 55 PCT respectively. 

North Dakota is the state with the highest usage with 17% of 

propiconazole of total pounds of A.I. applied (2009-2013). 

No usage data are available for the antimicrobial uses of 

propiconazole.

Formulation Type(s) Dry flowable, emulsifiable concentrate, ready to use, soluble 

concentrate, flowable concentrate, suspoemulsion, granular, and 

formulation intermediate. 

Application Method(s) Conventional products can be applied via ground and aerial 

broadcast spray, sprinkler irrigation, hose-end and pup-up 

sprayer, backpack and mist blower, dip treatment, or by 

chemigation. 

Antimicrobial products can be applied via brush/roller, airless 

sprayer, both non-pressure and pressure treatments, dip and spray 

treatment, and liquid pouring.

Technical Registrant(s) Syngenta Crop Protection, LLC; Nufarm Limited; Helena 

Chemical Company; Lanxess Corporation; Albaugh, LLC;

Janssen PMP; Dow Agrosciences LLC; ADAMA Irvita N.V.;

Sharda Cropchem Limited; Tide International; USA, Inc.;
11

Table 3: Propiconazole Use and Usage Information

Willowood Propiconazole, LLC; Jiangsu Fengdang Crop Science 

Co. LTD 

No. of Registrations 149 Section 3 products12, 3 Section 24(c) products. 

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below.

• Certain propiconazole labels are unclear with respect to application parameters such as 

the size of the treated area, the extent of a treated “spot,” retreatment intervals, or 

maximum annual application rates. Without further information, EPA expects to use 

conservative assumptions to approximate these parameters in order to conduct a 

quantitative risk assessment. However, the Agency will work with registrants to clarify 

information on propiconazole product labels, especially the maximum annual application 

rates for non-agricultural uses including golf courses, turf, and ornamental lawns.

• Confirmation of the following label information: sites of application; formulations;

application methods and equipment; maximum application rates; frequency of 

application, application intervals, and maximum number of applications per season; and 

geographic limitations on use.

• Use distribution (e.g., acreage and geographical distribution of relevant use sites).

• Median and 90th percentile reported use rates (lbs ai/A) from usage data – national, state, 

and county.

• Typical application timing (date of first application and application intervals) for each 

registered crop – national, state, and county.

• Usage/use information for non-agricultural uses.

• Typical application interval (days).

• If more than one application is typically made, the typical re-application interval (per 

crop).

• State or local use restrictions.

• Foreign technical registrants not listed above who supply technical propiconazole to the 

US market.

• Recent resistance reports for propiconazole in populations of important target pests, in 

particular, cases of cross-resistance to other fungicides. 

RECENT ACTIONS

There are several pending new food use applications under agency review. 

 12 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home).
12

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for propiconazole (conventional 

uses) was conducted in 2015 in support of a new use registration action. The most recent human 

health risk assessment (antimicrobial uses) for propiconazole was conducted in 2011 to 

incorporate new paint and stain data. The most recent drinking water assessment was conducted 

in 2013 in support of a new use registration action. The most recent ecological and 

environmental fate risk assessment was conducted in 2015 for a new use registration action. 

Findings and conclusions from these risk assessments are summarized in the Problem 

Formulation of the Environmental Fate and Ecological Risk in Support of the Registration 

Review of Propiconazole and Propiconazole: Human Health Risk Scoping Document in Support 

of Registration Review. 

During registration review, the Agency anticipates the need to conduct a comprehensive

ecological risk assessment, including an endangered species assessment, for all uses of

propiconazole. For human health, EPA anticipates the need to conduct revised dietary, 

residential, and occupational risk assessments during registration review. If toxicological 

endpoints or points of departure are revised based on the data that are anticipated to be required 

for registration review, they will be considered in the new assessments, as well as any changes to 

the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated registration review risk assessments based on the 

Problem Formulation and Scoping Document.
13

Table 4: Anticipated Risk Assessments for the Propiconazole Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate

Comprehensive ecological 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Yes 

 

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

propiconazole see page 13 of the Problem 

Formulation.

Human Health

Dietary

Food No The need for an updated dietary assessment for 

propiconazole will be considered during registration 

review. For conventional and antimicrobial uses, the 

Agency does not anticipate the need for a revised 

dietary assessment unless indicated by revised 

drinking water estimates.

It should be noted, that the Agency has previously 

assessed dietary risk from triazole-derived 

metabolites, 1-2,4-traizole and its conjugates 

triazolylanine and triazolyacetic acid, resulting from 

exposure to conazole fungicides (including 

propiconazole) as a group. The need for an updated 

dietary triazole assessment will be determined at the 

time of registration review.

Drinking water Yes It is anticipated that an updated drinking water 

assessment for propiconazole will be needed. 

It is also anticipated that an updated drinking water 

assessment will be needed for triazole-derived 

metabolites, 1-2,4-triaolze and its conjugates 

triazolyanin and triazolyacetic acid. 

Occupational

Handlers (mixers, loaders, 

applicators)

&

Post-application 

No

Conventional Uses: The Agency does not anticipate 

the need for a revised occupational assessment.

However, the need for updated occupational handler 

and post-application exposure assessments will be 

evaluated during registration review. 

Yes Antimicrobial Uses: The Agency anticipates the need 

to conduct new occupational exposure assessments to 

support wood and material preservation uses.

Residential
14

Handlers

Yes

Updated residential handler and post-application 

exposure assessments are anticipated as being needed 

for both conventional and antimicrobial uses to 

reflect current policies, data, and any updates to the 

toxicity database. 

The need for spray drift and valorization risk 

assessments for potential exposure to bystanders 

from agricultural applications will be examined 

during registration review.

Post-application

Other

Aggregate Yes Evaluates the combined risk from dietary and 

residential exposures.

It’s anticipated that an updated aggregate assessment 

will be needed if a new dietary exposure assessment 

is conducted, and/or if there are changes in estimated 

drinking water concentrations. 

The Agency has previously assessed dietary risk 

from triazole-derived metabolites, 1-2,4-traizole and 

its conjugates triazolylanine and triazolyacetic acid, 

resulting from exposure to conazole fungicides 

(including propiconizole) as a group. The need for 

an updated aggregate triazole assessment will be 

determined at the time of registration review.

Cumulative N/A Propiconazople has not been identified as a member 

of a cumulative group that shares a common 

mechanism of toxicity

Tolerances Yes The Agency anticipates revising the tolerance 

expression during registration review. 

Incidents Will check for 

updates

For a discussion of reported human incidents for 

propiconazole, see page 14 of the Scoping Document

and the Propiconazole: Tier I (Scoping) Review of 

Human Incidents and Epidemiology.

Guidance for Commenters: Additional ecological information requested for this registration 

review, and of particular interest to EPA, is described below.

• Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency.

• Water quality monitoring data (see Appendix for further details).
15

TIMELINE

EPA has created the following estimated timeline for the completion of the propiconazole

registration review in Table 5 below.

Table 5: Projected Propiconazole Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2015 – December

Close Public Comment 2016 – February

Case Development

Final Work Plan 2016 – June

Issue DCI 2016 – July - September

Data Submission 2018 – July - September

60-day Public Comment Period for Draft Risk 

Assessments13

2020 – January – March

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2020 – October – December

Registration Review Decision and Begin Post-Decision 

Follow-up

2021

Total (years) 6

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of propiconazole. 

 13 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
16

Appendix – Additional Areas Considered in the Propiconazole Registration 

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern. 

Water Quality:

Propiconazole is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.

14 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for propiconazole.15 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.

16 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process17 in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to propiconazole compared to the general population.

 14 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 15http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 16 http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/index.cfm 17 http://www.epa.gov/pesticide-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
17

Please comment if you are aware of any sub-populations that may have atypical, unusually 

high exposure compared to the general population.

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been 

conducted for propiconazole. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of propiconazole has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated critical 

habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for propiconazole, EPA 

reviewed these data and selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 

propiconazole is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 
18

of chemicals identified for EDSP screening was published on June 14, 201318 and includes some 

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. 

Propiconazole was included in the first group of chemicals issued an order to conduct Tier 1 

EDSP testing for which EPA has received all of the required Tier 1 assay data. The Agency has 

reviewed all of the assay data received for the appropriate List 1 chemicals, and the conclusions 

of those reviews are available in the chemical-specific public dockets (EPA-HQ-OPP-2009-

0634-0248). For additional information the EDSP program, visit

http://www2.epa.gov/endocrine-disruption

HUMAN STUDIES:

Occupational and Residential

Past propiconazole risk assessments rely in part on data from studies in which adult human 

subjects were intentionally exposed to a pesticide to determine their dermal and inhalation 

exposure. Many such studies, involving exposure to many different pesticides, comprise generic 

pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED), the 

Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task 

Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide 

generic exposure databases, and has found no clear and convincing evidence that the conduct of 

any of them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies.

 18 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.