2



### Tebuconazole Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 4

STATUTORY AND REGULATORY AUTHORITY

................................ ................................ ... 7

CHEMICAL FACTS

................................ ................................ ................................ ...................... 7

USE AND USAGE INFORMATION

................................ ................................ ............................ 8

RECENT ACTIONS

................................ ................................ ................................ ..................... 10

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

.............................. 10

TIMELINE

................................ ................................ ................................ ................................ .... 13

NEXT STEPS

................................ ................................ ................................ ............................... 14

Appendix

– Additional Areas Considered in the Tebuconazole Registration Review

............. 15

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. Registration Review

– Preliminary Problem Formulation for Ecological Risk and Drinking Water Assessments for Tebuconazole . November 24, 2015

2. Tebuconazole

. Human Health Scoping Document in Support of Registration Review

. December 7, 2015

3. Tebuconazole: Tier I (Scoping) Review of Human Incidents an d Epidemiology. October 28,

2015

.

4. BEAD Chemical Profile (BCP) for Registration Review: Tebuconazole (128997) . August 18, 2015

5. Tebuconazole (128997) Screening Level Usage Analysis (SLUA)

. April 29, 20153

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

found in the docket EPA

- HQ

- OPP

- 2015

- 0378 at http://www.regulations.gov

.

OVERVIEW

The docket for tebuconazole is now open, initiating the first public comment period f or this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0378 ) . Tebuconazole is a fungicide registered as a conventional pesticide with agricultural and non

- agricultural use patterns

, and as an antimicrobial pesticide with wood preservative, materials p reservative, and metalworking

fluid uses.

This Preliminary Work Plan (PWP) document explains what the United States Environmental Protection Agency’s (USEPA, EPA or “the Agency”) Office of Pesticide Programs (OPP) knows

about tebuconazole , 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 tebuconazole

.

The registr ation 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 tebuconazole and what t ypes of new data or other information would be helpful for the Agency to receive as it moves toward a decision on

tebuconazole . The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional informa tion 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 i nformation. 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 tebuconazole

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent ac tions, the anticipated risk assessments, and a projected registration review timeline for tebuconazole

. 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

information.4

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for tebuconazole

. For additional discussion of the anticipated data needs, see the Registration Review

– Preliminary Problem Formulation for Ecological Risk and Drinking Water Assessments for Tebuconazole and Tebuconazole. Human Health Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Tebuconazole Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for Tebuconazole

– Conventional and Antimicrobial Uses

850.4500 Algal toxicity study 2

, 3 TGAI 12

850.4550 Cyanobacteria toxicity 3 TGAI 12

Non

guideline Freshwater chronic sediment toxicity 4 TGAI 24

Non

guideline Estuarine/marine chronic sediment toxicity 5 TGAI 24

Anticipated Data Needs for Tebuconazole

– Conventional Uses Only

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.3020 Adult honey bee acute contact toxicity TGAI 12

850.3030 Honey bee toxicity of residues on foliage 6 TEP 12

850.3040 Field testing for pollinators (Tier 3) 6 TEP 24

850.4100 Seedling emergence (Tier 2) TEP 12

850.4150 Vegetative vigor (Tier 2) TEP 12

850.6100 Environmental chemistry methods/independent

laboratory validations in soil, water 7 TGAI 12

875.2100 Dislodgeable foliar residue and turf transferable

residues TEP 12

Non

guideline Acute oral toxicity to adult honey bees (Tier 1) 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 Algal t oxicity data required on t wo species of non

- vascular plants (freshwater and marine diatoms)

. 3 In a Federal Register Notice dated June 27, 2012, EPA split the Public Draft OPPTS 850.5400 test guideline into two test guidelines: OCSPP 850.4500 and OCSPP 850.4550. See “Final Test Guidelines; O CSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

2009

- 0154

- 0028

. 4 Chronic sediment toxicity data required on two freshwater species (an amphipod and a midge) in support of conventional uses. Only the freshwater amphipod data are required in support of antimicrobial uses.

5 C hronic sediment toxicity data required on one species o f estuar ine/marine amphipod in support of both

conventional and antimicrobial uses.

6 Study may be waived depending on results of Tier 1 pollinator studies.

7 ECM/ILV needed for soil and water.5

Table 1: Anticipated Data Needs for the Tebuconazole Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

guideline Acute oral toxicity to larval honey bees (Tier 1) TGAI 12

Non

guideline Chronic oral toxicity to adult honey bees (Tier 1) TGAI 12

Non

guideline Chronic oral toxicity to larval honey bees (Tier 1) TGAI 12

Non

guideline Field trial of residues in pollen and nectar 6 TEP 24

Non

guideline Semi

- field testing for pollinators 6 TGAI /TEP 24

Anticipated Data Needs for Tebuconazole

– Antimicrobial Uses Only

835.1110 Activated sludge sorption isotherm 8 TGAI 12

835.3110 Ready biodegradation 9

, 10 TGAI 12

835.3220 Porous pot 10 , 11 TGAI 12

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

- HQ

OPPT

- 2009

- 0152

- 0003

. 9 EPA has a published final guideline 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 Activated Sludge Respiration

I nhibition test.

10 The results of the Activated Sludge Respiration Inhibition Test (ASRI), GLN 850.3300, will determine which of the four biodegradation tests is/are required. ◦If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i) Bio degradation in Activated Sludge Study, GLN 835.3280 or (ii) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, GLN 835.3240, or (iii) the Porous Pot Test, GLN 835.3220 is required. If the ASRI test EC50 is greater than 20 mg/L,

then the registrant must conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge, or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot Test. ◦If the Ready Biodegradability study is cond ucted and passes, then no further testing is required. If, however, the antimicrobial fails the Ready Biodegradability study, then the (i) Biodegradation in Activated Sludge, or (ii)

Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, or (iii) the Porous Pot study is required.

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

- HQ

OPPT

- 2009

- 015 2

- 0024

. The biodegradation study required is based on results of an Activated Sludge Respiration

Inhibition test.

12 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.

13 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 te st.

14 EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study under guideline 850.3300: http://www.regulation s.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0021

. 15 OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd

ilibrary.org/content

/book/9789264070080

- en

. 16 The following data/scenarios are needed: pressure treatment, liquid pour, sapstain, brush/roller, and airless

sprayer.6

Table 1: Anticipated Data Needs for the Tebuconazole Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.3240 Simulation tests

— aerobic sewage treatment: A.

activated sludge 10, 12 TGAI 12

835.3280 Simulation tests to assess the biodegradability of

chemicals discharged to wastewater 10, 13 TGAI 12

850.3300 Activated sludge respiration inhibition (ASRI ) 14, 15 TGAI 12

875.1200 16 Dermal Applicator Data TEP 12

875.1400 16 Inhalation Applicator Data TEP 12

875.1700 Product Use Data TEP 12

875.2300 17 Indoor Residue Data (wipe study) TEP 12

TGAI = technical grade active ingredient; TEP = typical end

- use product

17 The wipe study is based on the need to assess dermal and incidental oral exposures to children playing on pressure treated decks and play sets.7

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, 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 o ccurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 11

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide A ct (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 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 F inal W ork P lan (FWP) and anticipated schedule for the registration review of tebuconazole

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for tebuconazole

.

Table 2: Chemical Facts for Tebuconazole

PC code 128997

Case Number 7004

CAS Number 107534

- 96

- 3

Year first registered 1994 Pesticide Type Fungicide

Chemical class Triazole

R eregistration Eligibility Decision (R E D) Tebuconazole was registered after November 1984 and therefore,

was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable. A TRED for tebuconazole was not needed because existing tolerances were re

- assessed as part of a new use/new tolerance action in 1999 ( 64 FR 1132, January 8, 1999 )

.

11 http://www2.epa.gov/pesticide

- reevaluation8 Table 2: Chemical Facts for Tebuconazole

Cumulative group Not applicable. Tebuconazole 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 tebuconazole are established in 40 CFR § 180.474

. There are no tolerances or tolerance exemptions for the antimicrobial uses of tebuconazole.

Dual

- use Tebuconazole is registered for conventional and antimicrobial

uses.
Non

- pesticidal uses There are no identified non

- pesticidal uses of tebuconazole.

Pe sticide Re

- evaluation Division, Chemical Review Manager José Gayoso, gayoso.jose@epa.gov, (703) 347

- 8652

Antimicrobials Division,

Chemical Review Manager Rachel Ricciardi, ricciardi.rachel@epa.gov, (703) 347

- 0465

Registration Division

, Product Manager Hope Johnson, johnson.hope@epa.gov, (703) 305

- 5410

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for tebuconazole

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Tebuconazole (128997), August 18, 2015

, in

the tebuconazole r egistration review docket for more details

.

Table 3: Tebuconazole Use and Usage Information

Summary of Use Tebuconazole is a systemic fungicide with protective, curative, and eradicant properties.

Use Sites Tebuconazole is registered for agricultural use on asparagus, barley, beans, beans (dried

- type), beets, brassica (head and stem vegetables), bulb vegetables, field com, popcorn, sweet com,

cotton, cucurbit vegetables, fruiting vegetables (except okra),

gar lic, grapes, hops, leek, oats, okra, dry bulb onions, green onions, peanuts, pome fruits, rye, shallot, soybeans, stone fruits, subtropical/tropical fruit, sunflower, tree nuts, turnip, and wheat.

Tebuconazole is registered for non

- agricultural convention al use

on golf cour se turf, grasses grown for seed, and ornamentals (grasses, trees, shrubs, vines, and flowering plants)

.

Tebuconazole is registered for antimicrobial use as a n above

ground and ground

- contact wood and wood

- based composite product preservative

, as a materials preservative in paper coatings, plastic, glues, adhesives, sealants, and metalworking / cutting fluids

.9 Table 3: Tebuconazole Use and Usage Information

Summary of Usage The primary agricultural use sites for tebuconazole are peanuts (average annual lbs a.i. = 385,000) and wheat (average annual lbs a.i. = 219,000 spring wheat, 192,000 winter wheat) . Average tebuconazole application rates range from 0.032 to 0.189 lb a.i. per acre for the major use sites in the United States. Highest average application rate across all regist ered use sites is 0.251 lb a.i. per acre for sugar beets.

According to the most recent data available, tebuconazole usage in

the Professional Ornamental and Turf market and Consumer market was 38,000 pounds and 10

, 000 lbs, respectively

, in 2011.

Usage da ta are not available for antimicrobial uses. Formulation Type(s) Tebuconazole is formulated as a granular, pelleted/tableted, wettable powder, water dispersible granules, emulsifiable concentrate, flowable concentrate, soluble concentrate, and

solution

- re ady to use (RTU).

Antimicrobial uses are formulated as powders and liquid

concentrates. Application Method(s) Conventional uses are applied by ground or air equipment and as

a seed treatment.

Antimicrobial application methods include liquid pour for metal working fluids, dip, spray, wood pressure treatment

, and remedial

treatment of in

- service wood using brushes and airless sprayers

. Technical Registrant (s) 1. Bayer Environmental Science

2. Winfield Solutions

3. Lanxess Corp.

4. Luxembourg Pamol

5. Albaugh LLC

6. Janssen

7. Nufarm

8. Repar

9. United Phosphorus

10. Adama Irvita N.V.

11. Rotam Limited

12. Source Dynamics, LLC

13. Sharda Cropchem Limited

14. T acoma Ag, LLC

15. A mtide, LLC

16. Tide International, USA, inc.

17. Willowood Tebuconazole, LLC10 Table 3: Tebuconazole Use and Usage Information

No. of Registrations 170 Section 3 products 12

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.

 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

.

 Usage/use information for non

- agricultural uses , specifically

o Site of application

o Maximum application rate

o Application frequency

o M aximum number of app lication per year

 F oreign technical registrants not listed above who supply technical tebuconazole to the

US market

.

RECENT AC TIONS

An import tolerance on oranges was established on May 7, 2014.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for tebuconazole was completed on December 31, 2013 in support of an import tolerance petition on oranges. T he most recent ecological and environmental fate risk assessment was completed in 2013 to evaluate tebuconazole use on home lawns, athletic fields, and sod . Findings and conclusions from these

risk assessments are s ummarized in the Registration Review

– Preliminary Problem Formulation for Ecological Risk and Drinking Water Assessments for Tebuconazole and Tebuconazole. Human Health Scoping Document in Support of Registration Review

.

During registration review, t he A gency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of

tebuconazole

. For human health, during registration review EPA anticipates the need to conduct

revised occupation al and residential post

- application risk assessments for conventional uses, as well as occupational handler and residential handler and post

- application risk assessments for

antimicrobial uses

. 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

.

12 Sec tion 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website ( http://oaspub.epa.gov/pestlabl/ppls.home11

Table 4 below summarizes the antic ipated registration review risk assessments based on the Registration Review

– Preliminary Problem Formulation for Ecological Risk and Drinking Water Assessments for Tebuconazole and Tebuconazole. Human Health Scoping Document in Support of Registration Re view

.12

Table 4: Anticipated Risk Assessments for the Tebuconazole 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 Y T he stressor of ecological concern for terrestrial and aquatic organisms for the ecological risk assessment will only be the parent compound, tebuconazole

.

Incidents Will check for updates For a discussion of reported ec ological incidents for

tebuconazole , see page 30 of the Problem

Formulation.

Human Health Dietary

Food N The dietary assessment is up to date and therefore not anticipated for Registration Review unless there are increases to the drinking water exposure estimates that need to be incorporated.

Drinking water N The dietary assessment is up to date and therefore not anticipated for Registration Review unless there are increases to the drinking water exposure estimates that need to be incorporated.

Occupational Handlers (mixers, loaders, applicators) N Conventional use occupational handler risk assessments are up to date and therefore not anticipated for Registration Review.

Y Antimicrobial use occupational handler risk

assessments are anticipated for Registration Review in support of wood and material preservation uses

.

Post

- application Y A revised conventional use occupational post

application risk assessment is anticipated to address uncertainty in turf transferable residue s and dislodegable foliar residue s.

N A revised antimicrobial occupational post

- application

risk assessment is not anticipated because a ny exposure for wood pressure treatment plants and machinists will already be captured in the occupational handler assessment.

Residential

Handlers N Conventional use residential handler risk assessments are up to date and therefore not anticipated for Registration Review.13 Y Antimicrobial use residential handler risk assessments

are anticipated for Registration Review in support of the application of treated stains.

Post

- application Y A revised conventional use residential post

application risk assessment is anticipated to ad dress uncertainty in turf transferable residue s.
Y A revised antimicrobial residential post

- application

risk assessment is anticipated to address exposure to treated wood and plastic.

Other Aggregate Y The short

- term aggregate assessment will be re

evaluated when the residential assessment is updated.

Cumulative N T here is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the

conazoles.

Tolerances N A tolerance re

- assessment is not anticipated in Registration Review. However, some tolerance expressions may be updated.

Incidents Will check for updates For a discussion of reported human incidents for

tebuconazole

, see page 14 of the Scoping Document

and the Tebuconazole: Tier I Review of Human

Incidents

.

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 olo gical 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)

.

TIMELINE

EPA has created the following estimated timeline for the completion of the tebuconazole registration review in Table 5 below

.

Table 5: Projected Tebuconazole Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period December 2015

Close Public Comment February 2016 Case Development

Final Work Plan May 2016

Issue DCI July

– Sept. 201614 Table 5: Projected Tebuconazole Registration Review Timeline

Activities Estimated Dat e Data Submission July

– Sept. 2018

6 0

- day Public Comment Period for Draft Risk

Assessments 13 January

– March 2020

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision October

– December 2020

Registration Review Decision and Begin Post

- Decision

Follow

- up April

– June 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 tebuconazole

.

13 The regulations governing Registration Review generally requi re 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.15



### Appendix

– Additional Areas Considered in the Tebuconazole 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 irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency

will work to harmonize tolerances and internation al 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:

Tebuconazole is not identifi ed 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 tebuconazole

. 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 Impaire d 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 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 addres s 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 tebuconazole c ompared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure 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/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_ group_name=PESTICIDES

16 http://www.epa.gov/tmdl

17 http://www2.epa.gov/pesticide

- reeval uation/opp

- guidance

- submission

- state

- and

- tribal

- water

- quality

- monitoring

data16

ENDANGERED SPECIES :

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

conducted for tebuconazole

. The ecological risk assessment planned during registration review

will allow t he Agency to determine whether use of tebuconazole has “no effect” or “may affect” federally listed threatened or endangered s pecies (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 Nat ional 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 stud ies 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, inc luding 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

chron ic studies that assess gr owth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for tebuconazole 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),

tebuconazole is subject to the endocrine screening part of the Endocr ine 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

ch emical 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 relations hip 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 of chemicals identified for EDSP screening was published on June 14, 2013 18 and includes some

18 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.17

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.

Tebuconazole is on List 1 for which EPA has received all 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 (see EPA

- HQ

OPP

- 2015

- 0378 for tebuconazole ).

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website. 19

HUMAN STUDIES :

Occupationa l and Residentia l

The risk assessments which have been previously conducted for tebuconazole rel ied 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, in volving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide

Ha ndlers Exposure Database (PHED), the Agricultural Handler Exposure Task Force (AHETF) database, the Outdoor Residential Exposure Task Force (ORETF)

, the Agricultural Reentry Task Force (ARTF) Database and the Antimicrobial Exposure Assessment Task Force II (AEATF II). EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases,

and has found no clear and conv incing 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. 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

.

19 http://www2.epa.gov/endocrine

- disruption