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 summarizes 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 and 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, 2015
3

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 for 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 preservative, 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 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 tebuconazole and what types 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 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 tebuconazole. 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 tebuconazole. 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.
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

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for Tebuconazole – Conventional and Antimicrobial Uses

850.4500 Algal toxicity study2, 3 TGAI 12

850.4550 Cyanobacteria toxicity3 TGAI 12

Nonguideline Freshwater chronic sediment toxicity4 TGAI 24

Nonguideline Estuarine/marine chronic sediment toxicity5 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 foliage6 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, water7 TGAI 12

875.2100 Dislodgeable foliar residue and turf transferable 

residues TEP 12

Nonguideline 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028

2 Algal toxicity data required on two 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; OCSPP 850 Series; Notice 

of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT2009-0154-0028. 

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 Chronic sediment toxicity data required on one species of estuarine/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

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

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

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

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

Nonguideline Field trial of residues in pollen and nectar6 TEP 24

Nonguideline Semi-field testing for pollinators6 TGAI/TEP 24

Anticipated Data Needs for Tebuconazole – Antimicrobial Uses Only

835.1110 Activated sludge sorption isotherm8 TGAI 12

835.3110 Ready biodegradation9, 10 TGAI 12

835.3220 Porous pot10, 11 TGAI 12

 

8 EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0152-0003. 

9 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.

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) Biodegradation 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 conducted 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-HQOPPT-2009-0152-0024. 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-HQOPPT-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-HQOPPT-2009-0152-0036. The biodegradation study required is based on results of an Activated Sludge Respiration 

Inhibition test.

14 EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study 

under guideline 850.3300: http://www.regulations.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.oecdilibrary.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

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.3240 Simulation tests—aerobic sewage treatment: A. 

activated sludge10, 12 TGAI 12

835.3280 Simulation tests to assess the biodegradability of 

chemicals discharged to wastewater10, 13 TGAI 12

850.3300 Activated sludge respiration inhibition (ASRI)

14, 15 TGAI 12

875.120016 Dermal Applicator Data TEP 12

875.140016 Inhalation Applicator Data TEP 12

875.1700 Product Use Data TEP 12

875.230017 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 occurs, products in the marketplace can be used safely. Information 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 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 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

Reregistration Eligibility 

Decision (RED)

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-reevaluation
8

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.

Pesticide 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 registration 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), 

garlic, 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 conventional use 

on golf course turf, grasses grown for seed, and ornamentals 

(grasses, trees, shrubs, vines, and flowering plants).

Tebuconazole is registered for antimicrobial use as an aboveground 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 registered 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 data 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-ready 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. Tacoma Ag, LLC

15. Amtide, LLC

16. Tide International, USA, inc.

17. Willowood Tebuconazole, LLC
10

Table 3: Tebuconazole Use and Usage Information

No. of Registrations 170 Section 3 products12

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.

 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.

 Usage/use information for non-agricultural uses, specifically

o Site of application

o Maximum application rate

o Application frequency

o Maximum number of application per year 

 Foreign technical registrants not listed above who supply technical tebuconazole to the

US market.

RECENT ACTIONS

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. The 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 summarized 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, the Agency 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 occupational 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 

assessments, as well as any changes to the standard operating procedures or default exposure 

assumptions.

 

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

(http://oaspub.epa.gov/pestlabl/ppls.home
11

Table 4 below summarizes the anticipated 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 Review.
12

Table 4: Anticipated Risk Assessments for the Tebuconazole 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 

Y The 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 ecological 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 postapplication risk assessment is anticipated to address 

uncertainty in turf transferable residues and 

dislodegable foliar residues.

N A revised antimicrobial occupational post-application 

risk assessment is not anticipated because any 

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 postapplication risk assessment is anticipated to address 

uncertainty in turf transferable residues.

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 reevaluated when the residential assessment is updated.

Cumulative N There 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 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).

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 Date

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. 2016
14

Table 5: Projected Tebuconazole Registration Review Timeline

Activities Estimated Date

Data Submission July – Sept. 2018

60-day Public Comment Period for Draft Risk 

Assessments13

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 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 tebuconazole.

 

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.
15

Appendix – Additional Areas Considered in the Tebuconazole 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:

Tebuconazole 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 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 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 tebuconazole compared 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

15http://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-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
16

ENDANGERED SPECIES:

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

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

will allow the Agency to determine whether use of tebuconazole 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 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 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 

of chemicals identified for EDSP screening was published on June 14, 201318 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-HQOPP-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:

Occupational and Residential

The risk assessments which have been previously conducted for tebuconazole relied 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 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 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. 

 

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