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 P ropiconazole Registration Review

............ 16

References:

This Preliminary Work Plan summarize s 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
typ es 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 pa rticipation component to solicit input from interested stakeholders. The Agency intends, b y 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 proces s 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:

en vironmental 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 anti cipated data needs for propiconazole. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a project ed registration review timeline for propiconazole. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in R egistration R eview along with some additional chemical case

- specific
informati on.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 Propiconazol e and Propiconazole:
Human Health Ri sk Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Propiconazole Registration Review

Guideline

Number (GLN) 1 Study Title 1 Test Material Estimated
Timeframe
(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Propiconazole

835.1110 2

, 9 Activated sludge sorption isotherm (ASSI) TGAI 12

835.3110 3

, 9 Ready biodegradability TGAI 12

835.3220 4

, 9 Porous pot test TGAI 12

835.3240 5

, 9 Simulation test

– aerobic sewage treatment: A. activated sludge units TGAI 12

835.3280 6

, 9 Simulation tests to assess the primary and ultimate biodegradability of chemicals discharged

to wastewater TGAI 12

850.1075 7

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

850.1400 7 ,8 Estuarine/marine fish early

- life stage (ELS) TGAI 12

850.2100 7 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 A vailability” 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

- HQ

OPPT

- 2009

- 0152

- 0003

. 3 EPA has a published final guideli ne for this study: http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

OPPT

- 2009

- 0152

- 0017

. The biodegradation study required is based on results of an Activate d Sludge Respiration
Inhibition test

4 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

OPPT

- 2009

- 0152

- 002 4

. 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

- HQ

OPPT

- 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

- HQ

OPPT

- 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 Title 1 Test Material Estimated
Timeframe
(Months from receipt of DCI)

850.2300 7 Avian re production (mallard duck) TGAI 12

850.3300
or OECD

Test
Guideline
209 9 Activated sludge respiration inhibition (ASRI) TGAI 12

875.1700 9 Product use information (paints and stains) TEP 12

875.2100 7 T urf transferable resides (TTR) TEP 24

875. 2700 9 Product use information (wood preservatives) TEP 12

Non

- GLN 9 Chronic Freshwater Sediment Testing: (Hyallela azteca) (TGAI) TGAI 24

Non

- GLN 9 Chronic Freshwater Sediment Testing: (Chironomus dilutus or C. tentans) TGAI 24

Non

- GLN 9 Chronic Estuarine/Marine Sediment Testing: (Leptocheirus plumulosus) (TGAI) TGAI 24

Non

- GLN

[ OECD
TG 237 (Tier I) ] 7 Honeybee larva e 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 larv ae 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 R esidues 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 Title 1 Test Material Estimated
Timeframe
(Months from receipt of DCI)

Outstanding Data Requirements from Antimicrob ial RED GDCI

- 122101

- 31121 10

Guideline
Number Study Title Status

875.1100 Dermal Exposure

– outdoor

Data in review. 875.1200 Dermal exposure

– indoor

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 envi ronment 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n 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

. T he Agen cy 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 wha t 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 F inal W ork P lan (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

R eregistration Eligibility Decision (R E D) 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

- reevaluation9 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 Tolera nces 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

- p esticidal 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

Antimicrobial s Division,
Chemical review Manager Sandra O’Neill, oneill.sandra@epa.gov , (703) 347

- 0141

Antimicrobials Division,
Product Man ager 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 reg istered for use on a number of agricultural

, non

- agricultural , and antimicrobial sites

. Use Sites Conventional Uses

A gricultural : S tone 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

N on

- A gricultural : C ommercial, public and residential ornamental, landscapes and turf

.

Antimicrobial Uses Propiconazole is registered fo r use in two major antimicrobial use patterns

, material preservative s and wood preservative s . 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, t he conventional use of propiconazole has been increasing since 200 4 with a slight
decrease in use from 2008

- 2010.

For years 2009

- 2013 , propiconazole annual usage averaged

1 4

, 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 resp ectively.
North Dakota is the st ate 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) Convention al p roducts 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 treatment s, dip and spray

treatment, an d 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 products 12 , 3 Section 24 ( c ) products.

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , 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, t he 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

.

• C onfirmation 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

.

• U se distribution ( e.g. , acr eage and geographical distribution of relevant use sites )

.

• M edian and 90 th percentile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

.

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

reg istered 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)

.

• S tate or local use restriction s

.

• F oreign 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 Produ ct Label System (PPLS) website

( ht tp://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 c onduct ed 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 conduct ed in 2013 in support of a new use registration action

. T he most recent ecological and
environmental fate risk assessment was conducted in 201 5 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 a nd Propiconazole: Human Health Risk Scoping Document in Support of Registration Review.

During registration review, t he 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 ris k assessment s 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 assessment s , as well as any changes to
the standard operating p rocedures or default exposure assumptions

.

T able 4 below summarizes the anticipated registration review risk assessments based on the
Problem Formulation and Scoping Document

.13 Table 4: Anticipated Risk Assessme nts for the Propiconazole Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical 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
drink ing 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 I t 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 N o 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 r egistration review.

Y es Antimicrobial Uses: The Agency anticipates the need to conduct new occupational exposure assessments to support wood and material preservation uses.

Residential14 Handlers

Y es 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 v alorization risk assessments for potential exposure to bystanders from agricultural applications wi ll be examined during registration review. Post

- application

Other Aggregate Y es E valuates 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 r egistration r eview.

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 Commente rs: Additional ecological i nformation r equested for this registration

r eview , and of particular interest to EPA, is described below.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring 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: P rojected Propiconazole Registration Review Timeline

Activities Estimated Dat e 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

6 0

- day Public Comment Period for Draft Risk

Assessments 13 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 6 0

- 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 p esticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.16 

### Appendix

– Additional Areas Considered in the Propiconazole Registration
Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade
irrit ants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency
will work to harmonize tolerances and international maximum residue limits (MRL s ) 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, n o Total Maximum Daily Load s (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 Process 17 in order to ensure they can be used quantitatively or qualitatively in pesticide risk asses sments.

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 environm ental 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
atyp ical, 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

15 http://iaspub.epa.gov/tmdl_waters10/attai ns_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

- monitoring

data17 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 as sessment that supports a complete endangered species determination has not been
conducted for propiconazole

. The ecological risk assessment planned during registration review
will allow t he 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

out comes 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 end points 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 ecologi cal 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

Pr ogram (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 e ndocrine 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 intera ct 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 t he 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 ingred ients and 9 inert ingredients. A second list18 of chemicals identified for EDSP screening was published on June 14, 2013 18 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 :

Occupationa l and Residentia l

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 gen eric pesticide exposure databases such as the Pesticide Ha ndlers 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 t hese 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 resea rch was conducted. A ll applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been
satisfied , and t here 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.