Docket Number EPA-HQ-OPP-2016-0114 

www.regulations.gov 

Triadimefon and Triadimenol Preliminary Work Plan 

Approved 

by: 

Date: 

Registration Review: Initial Docket 

Case Numbers 2700 & 7008 

March 2016 

Steve Knizner 

Director Director 

Pesticide Re-evaluation Division Antimicrobials Division 
Triadimefon and Triadimenol Preliminary Work Plan- Table of Contents 

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

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

STATUTORY AND REGULATORY AUTHORITY ................................................................... 7 

CHEMICAL FACTS ...................................................................................................................... 9 

USE AND USAGE INFORMATION .......................................................................................... 10 

RECENT ACTIONS ..................................................................................................................... 12 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW .............................. 13 

TIME LINE ....................................................... ............................................................................. 17 

NEXT STEPS ............................................................................................................................... 17 

Appendix -Additional Areas Considered in the Triadimefon and Triadimenol Registration 

Review ........................ ..... .. .... ......... ............................. ........................ ............. ........................ 18 

References: 

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

based on the following documents: 

1. Triadimefon and Triadimenol: Registration Review Problem Formulation. N.E. Federoff. 

March 14,2016. 

2. Triadimefon and Triadimenol. Human Health Assessment Scoping Document in Support of 

Registration Review. Michael A. Doherty. March 23, 2016. 

3. Triadimefon: Tier I (Scoping) Review of Human Incidents and Epidemiology. Elizabeth 

Evans. February 2, 2016. 

4. Triadimenol: Tier I (Scoping) Review of Human Incidents and Epidemiology. Elizabeth 

Evans. February 2, 2016. 

5. BEAD Chemical Profile (BCP)for Registration Review: Triadimefon (109901) and 

Triadimenol (127201) Tara Chandgoyal. March 30,2016. 

2 
6. Triadimefon (109901) Screening Level Usage Analysis (SLUA). July 18, 2014. 

7. Triadimenol (127201) Screening Level Usage Analysis (SLUA). July 21,2014 

8. EFED Table 1 Report Ingredient: Triadimefon (109901). November 6, 2014. 

9. EFED Table 1 Report Ingredient: Triadimenol (127201). October 8, 2014. 

10. HED Master Label Report Ingredient: Triadimefon (109901). November 6, 2014. 

11. HED Master Label Report Ingredient: Triadimenol (127201). October 8, 2014. 

These and other supporting documents for the triadimefon and triadimenol registration review 

case may be found in the docket EPA-HQ-OPP-2016-0114 at http://www.regulations.gov. 

3 
OVERVIEW 

The docket for triadimefon and triadimenol is now open, initiating the first public comment 

period for this registration review (docket number EPA-HQ-OPP-20 16-0 114). This case includes 

the following active ingredients (a.i.): triadimefon and triadimenol. Triadimefon and triadimenol 

are triazole-derivative fungicides. Triadimenol is a metabolite oftriadimefon and is also a 

registered active ingredient. Triadimefon is registered as an antimicrobial fungicide to preserve 

wood and as a conventional fungicide for use on pine seeds/seedlings, Christmas trees, 

ornamental plantings and landscapes (exterior/interior), and turf in commercial and residential 

settings. Triadimenol is registered as a conventional fungicide for seed treatment on barley, com, 

cotton, oats, rye, sorghum, and wheat. There are no antimicrobial registrations for the a.i. 

triadimenol. 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 triadimefon and triadimenol, 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 triadimefon and triadimenol. 

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 triadimefon and triadimenol and what types 

of new data or other information would be helpful for the Agency to receive as it moves toward a 

decision on triadimefon and triadimenol. 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 triadimefon and 

triadimenol. 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 triadimefon and 

triadimenol. 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 

Tables 1 and 2 below summarizes anticipated data needs for triadimefon and triadimenol. For 

additional discussion of the anticipated data needs, see the Triadimefon and Triadimenol: 

Registration Review Problem Formulation and Triadimefon and Triadimenol. Human Health 

Assessment Scoping Document in Support of Registration Review. 

. Table 1: Anticipated Data Needs for the Registration Review ofTriadimefon 

Data Needed for Estimated Conventional Use Guideline Time frame 

. 

Study Title1 Test (C) or Number1 (Months from Material Antimicrobial 

Use (A) receipt of DC I) 

90-day subchronic inhalation 

870.3465 toxicity TGAI c 24 

Field accumulation in rotational 

860.1900 crops2 TEP c 24 

Foliar dislodgeable residue 

875.2100 dissipation3 TEP c 24 

Independent laboratory validation 

850.6100 of analytical methods (soil +water) TGAI c 24 

Non- Frozen storage stability TGAI c 12 guideline 

835.2410 Photodegradation on soil TGAI c 12 

Terrestrial plant toxicity (seedling 

850.4100 emergence) TEP c 12 

Terrestrial plant toxicity (vegetative 

850.4150 vigor) TEP c 12 

Non- Honey bee adult acute oral TGAI c 12 guideline 

Non- Honey bee adult chronic oral TGAI c 12 guideline 

Non- Honey bee larval acute exposure TGAI c 12 guideline 

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=EP A-HQ-OPPT -2009-0154-0028 2 Additional data (extended field residue data) may be required depending upon result of limited field residue data 3 Applicable to use on pineapple. 

5 
·~"· 

Table 1: Anticipated Data Needs for the Registration Review of Triadimefon 

;-<1,., 

Data Needed for 

Estimated Conventional Use Guideline Timeframe Study Title1 Test (C) or Number1 (Months from Material Antimicrobial 

Use (A) receipt ofDCI) - Non- Honey bee larval chronic exposure TGAI c 12 guideline 

Non- Residues in pollen and nectar4 

TEP c 24 guideline 

Non- Semi-field testing for pollinators5 

TEP c 24 guideline 

850.3040 Full-field testing for pollinators6 

TEP c 24 

875.1400 Inhalation Exposure - Indoor - TEP A 24 Applicator Data 7 

875.1200 Dermal Exposure - Indoor - TEP A 24 Applicator Data3 

875.1700 Product Use Information8 TEP A 12 

875.2300 Indoor Surface Residue Dissipation9 TEP A 12 

Aerobic soil metabolism (three 

835.4100 soils) TGAI C+A 24 

Aerobic aquatic metabolism study 

835.4300 (two systems) TGAI C+A 24 

835.4400 Anaerobic aquatic metabolism TGAI C+A 24 

Estuarine/marine fish early life850.1400 stage toxicity test TGAI C + A 12 

4 Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and /or other lines of 

evidence, and the need for a refined pollinator risk assessment. 5 The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined 

based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment. 6 The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data 

and the need for a refmed pollinator risk assessment. 7 The following surrogate applicator exposure data/scenarios are needed for antimicrobial uses: mixing/loading, 

wettable powders, dip/spray sapstain, and pressure treatment. 8 Product use data for antimicrobials uses is needed to clarify uses, application rates (wood retentions), and 

application equipment. 9 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. This data is needed for antimicrobials uses only. See the Problem Formulation regarding 

the use of proprietary data generated by the Antimicrobial Exposure Assessment Task Force 11 and the Sapstain 

Industry Group. 

6 
Table 1: Anticipated Data Needs for the Registration Review of Triadimefon 

Data Needed for Estimated Conventional Use 

Guideline Study Title 1 Test (C) or 

Timeframe 

Number

1 (Months from Material Antimicrobial 

Use (A) receipt of DCI) 

Non- Chronic toxicity to benthic 

guideline invertebrates (three species) 10 TGAI C+A 12 

850.4550 Aquatic plant with blue-green alga 11 

TEP C+A 12 

TGAI = techmcal grade acttve mgredtent; TEP = typtcal end-use product; 

Table 2: Anticipated Data Requirements for the Registration Review of Triadimenol 

Data Needed for Estimated 

Guideline 

Conventional Use Timeframe 

Number12 Study Title1 

Test Material 

(C) or 

(Months from Antimicrobial Use 

(A) receipt of DCI) 

' 

835.4100 Aerobic soil metabolism TGAI c 24 

Independent laboratory validation 

850.6100 of analytical methods (soil + TGAI c 24 

water) 

Non- Frozen storage stability c 12 guideline TGAI 

Estuarine/marine acute 

850.1025 invertebrate toxicity (mollusk) TGAI c 12 

Estuarine/marine acute 

850.1035 invertebrate toxicity (shrimp) TGAI c 12 

10 Whole sediment; three test species: freshwater amphipod, freshwater midge, and estuarine/marine amphipod. The 

Agency's Environmental Fate and Effects Division recommends that the registrant consider Agency-wide guidelines 

for chronic testing of freshwater and estuarine/marine organisms, because the 850 guidelines are in the process of 

being finalized. A protocol must be submitted for review prior to initiating the studies. 11 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-OPPT2009-0 154-0028. 12 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 -2009-0 154-0028 

7 
... Table 2: Anticipated Data Requirements for the Registration Review ofTriadimenol 

Data Needed for Estimated I' Conventional Use 

Guideline Study Title1 

,_ (C) or 

Timeframe 

Number12 Test Material (Months from ~ Antimicrobial Use 

(A) receipt of DCI) ~ 

Estuarine/marine acute fish 

850.1075 toxicity (sheepshead minnow) TGAI c 12 

Estuarine/marine invertebrate full 

850.1350 life-cycle toxicity (mysid) TGAI c 24 

850.4400 Aquatic plant with Lemna spp TEP c 12 

Terrestrial plant toxicity 

850.4100 (seedling emergence) TEP c 12 

Non- Chronic toxicity to benthic 

TGAI 

c 

guideline invertebrates (three species) 12 

Non- Honey bee adult acute oral TGAI 

c 

guideline 12 

Non- Honey bee adult chronic oral TGAI c 

guideline 12 

Non- Honey bee larval acute exposure TGAI 

c 

guideline 12 

Non- Honey bee larval chronic TGAI 

c 12 guideline exposure 

Non- Residues in pollen and nectar 13 TEP 

c 24 guideline 

Non- Semi-field testing for TEP 

c 

guideline pollinators 14 24 

850.3040 Full-field testing for pollinators 15 

TEP c 24 

TGAI = technical grade active ingredient; TEP = typical end-use product 

13 Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and /or other lines of 

evidence, and the need for a refined pollinator risk assessment. 14 The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined 

based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment. 15 The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data 

and the need for a refined pollinator risk assessment. 

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 EPA, 

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.

16 

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 15 5.40. 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 triadimefon and triadimenol. 

CHEMICAL FACTS 

Table 3 provides a summary of the chemical facts for triadimefon and triadimenol. 

Table 3: Chemical Facts for Triadimefon and Triadimenol 

PC codes Triadimefon: 109901 and Triadimenol: 127201 

Case Number Triadimefon: 2700 and Triadimenol: 7008 

CAS Number Triadimefon: 43121-43-3 and Triadimenol: 55219-65-3 

Year first registered Triadimefon: 1968 and Triadimenol: 1984 

Pesticide Type Both triadimefon and triadimenol are fungicides. 

Chemical Class Triazole 

Reregistration Eligibility Reregistration Eligibility Decision for Triadimefon. August 1, 

Decision (RED) 2006. 

Tolerance Reassessment Tolerance Reassessment for Triadimenol. August 1, 2006. 

Eligibility Decision 

(TRED) 

16 http://www2.epa.gov/pesti cide-reevaluation 

9 
Table 3: Chemical Facts for Triadimefon and Triadimenol 

Cumulative group Not applicable. Triadimefon and triadimenol have not been 

identified as a member of a cumulative group that shares a 

common mechanism of toxicity. However, this class of 

compounds does produce common metabolites that will be 

assessed separately from their parent compounds in an aggregates 

strategy that takes into account the multiple active ingredients 

involved in their formation and the various sources of exposure. 

40 CFR Citation Triadimefon: 

A permanent tolerance for residues of triadimefon (as triadimefon 

plus triadimenol, expressed as triadimefon) in/on pineapple is 

currently listed in 40 CFR 180.410. There are no tolerances or 

tolerance exemptions for the antimicrobial uses of triadimefon. 

Triadimenol: 

Permanent tolerances for residues oftriadimenol (as triadimenol 

plus its butanediol metabolite calculated as triadimenol) are listed 

in 40 CFR 180.450. 

Dual-use Triadimefon is registered for conventional and antimicrobial uses. 

Triadimenol is registered for conventional uses only. 

Non-pesticidal uses There are no identified non-pesticidal uses of triadimefon and 

triadimenol. 

Pesticide Re-evaluation Christina Motilall, motilall.christina@epa.gov, (703) 603-0522 

Division, Chemical 

Review Manager 

Antimicrobials Division, Rachel Ricciardi, ricciardi.rachel@epa.gov, (703) 347-0465 

Chemical Review 

Manager 

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

Product Manager 

Antimicrobials Division, Jacqueline Hardy, hardy.jacgueline@epa.gov, (703) 308-6416 

Product Manager 

USE AND USAGE INFORMATION 

Table 4 summarizes the use and usage information for triadimefon and triadimenol. Please see 

the BEAD Chemical Profile (BCP) for Registration Review: Triadimefon (1 09901) and 

Triadimenol (12 7201) in the registration review docket for more details. 

10 
Table 4: Triadimefon and Triadimenol Use and Usage Information 

Summary of Use 

Summary of Usage 

Triadimefon: 

Triadimefon was first registered as a fungicide in the U.S. in 1968 

(USEP A, 2006) and a Triadimefon RED and Triadimenol TRED 

was published in 2006. 

Triadimefon was initially registered for food uses, such as apples, 

pears, grapes, raspberries as well as other non-food uses. As part 

of the RED, all food uses were removed except for pineapple. 

Current uses of triadimefon include Christmas trees, forest trees, 

non-bearing fruit trees, commercial/industrial lawns, residential 

and recreational lawns, golf course turf, ornamentals, and 

pineapple. 

The antimicrobial uses of triadimefon include wood treatment for 

wood-based composite products, wood products intended for 

above ground and in-ground contact, reconstituted wood-based 

composite products, and veneer-based wood products. 

Triadimenol: 

Triadimenol was first registered in 1984. Triadimenol is mainly 

used as cotton seed treatment for protection from soil-borne 

fungal pests. It is also registered as a seed treatment for barley, 

corn, cotton, oats, rye and wheat. Triadimenol is also registered as 

a fungicide for grasses. 

Triadimefon: 

Agricultural: According to private market usage data from 1998 

to 2012, usage for triadimefon decreased from approximately 

12,000 lbs. a.i. in 1998 to less than approximately 50 lbs. a.i. in 

2012. 

Non-agricultural: use of triadimefon for turf management and 

horticulture was approximately 4 7 thousand lbs. a.i. in 2002, 61 

thousand lbs. a.i. in 2004. Current estimates of non-agricultural 

use of triadimefon is 114 thousand lbs. a.i. on turf and 

floriculture. 

Usage data are not available for antimicrobial uses. 

Triadimenol: 

11 
Table 4: Triadimefon and Triadimenol Use and Usage Information 

Agricultural: Based on private market usage data from 2006-

2012, usage for triadimenol averaged approximately 1,500 

pounds active ingredient (lbs. a.i.) annually. 

Formulation Type(s) Triadimefon: Wettable powder, fluid concentrate, dry flowable, 

ready-to-use, granular and soluble concentrate. 

Triadimenol: Flowable concentrate and soluble liquid concentrate. 

Application Method(s) Triadimefon is applied as chemigation, spray, broadcast, tree 

injection treatment, seed treatment, mixing or milling treatment, 

dip/spray sapstain, and wood pressure treatment. 

Triadimenol is applied as a seed treatment. 

Technical Registrant(s) Triadimefon: Lanxess Corporation, Bayer CropScience 

Triadimenol: Bayer CropScience 

No. of Registrations Triadimefon: 19 Section 3 products 17 

Triadimenol: 2 Section 3 products 

Restricted Use No 

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

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

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

application methods and equipment; maximum application rates; frequency of 

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

geographic limitations on use. 

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

• Median and 901

h percentile reported use rates (lbs a.i./A) from usage data - national, 

state, and county. 

• Typical application timing (date of first application and application intervals) - national, 

state, and county. 

• Usage/use information for non-agricultural uses. 

• Typical application interval (days). 

• State or local use restrictions. 

• Foreign technical registrants not listed above who supply technical triadimefon and 

triadimenol to the US market. 

RECENT ACTIONS 

The RED/TRED was completed in 2006, and in 2009 the Agency assessed use of triadimefon on 

residential lawns/turf. Since that time no other regulatory actions have occurred with either 

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

(http:/ /oaspub.epa. gov/pestlab 1/ppls.home ). 

12 
triadimefon or triadimenol. Triadimefon was among the List 1 compounds to undergo the 

Endocrine Disruption Screening Program. The Agency has received and reviewed all of the Tier 

1 assay data for triadimefon and the other List 1 chemicals. Based on weight of evidence 

considerations, mammalian and wildlife EDSP Tier 2 testing are NOT recommended since there 

was a lack of convincing evidence of potential interaction with the estrogen, androgen or thyroid 

pathways. These reviews are available in the chemical-specific public dockets, see EPA-HQOPP-20 16-0114 for triadimefon; triadimenol was not included on List 1 or List 2. 

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 see the 

Appendix, or visit our website. 18 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

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

ecological risk assessment for all uses of triadimefon and triadimenol (both antimicrobial and 

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

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

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

be required for registration review, they will be considered in the new assessments, as well as 

any changes to the standard operating procedures or default exposure assumptions. 

Table 5 below summarizes the anticipated registration review risk assessments based on the 

Triadimefon and Triadimenol: Registration Review Problem Formulation and Triadimefon and 

Triadimenol Human Health Assessment Scoping Document in Support of Registration Review. 

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

13 
Table 5: Anticipated Risk Assessments for the Registration Review of 

Triadimefon and Triadimenol 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y ESA? 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Incidents Will check for For a discussion of reported ecological incidents see 

updates the Triadimefon and Triadimenol: Registration 

Review Problem Formulation. 

Human Health 

Dietary 

Food y An updated drinking water analysis (combining 

residues of triadimefon and triadimenol) is anticipated 

for registration review. 

An updated dietary analysis for the conventional uses Drinking water y is anticipated in order to incorporate (i) updated 

drinking water exposure estimates; (ii) anticipated 

rotational crop residue data, and; (iii) the most recent 

dietary consumption estimates. 

The wood treatment uses of triadimefon and 

triadimenol are not expected to significantly 

contribute to dietary (drinking water) exposure, and 

no other dietary exposure is anticipated from the 

antimicrobial uses of these compounds. 

Occupational 

Handlers (mixers, loaders, y An updated occupational handler assessment is 

applicators) anticipated for the conventional uses of both 

triadimefon and triadimenol that will reflect any 

revised endpoints and updated exposure inputs and 

methodologies. 

Occupational handler risks from the antimicrobial 

uses of triadimefon will also be evaluated during 

registration review based upon anticipated data 

requirements. 

14 
Post-application y A revised occupational post-application risk 

assessment is anticipated for the conventional uses of 

triadimefon and triadimenol to reflect updates to postapplication exposure assumptions and assessment 

methodologies. 

Occupational post-application exposure is not 

anticipated from the antimicrobial uses of 

triadimefon. 

Residential 

Handlers y For triadimefon, a revised residential handler 

assessment is anticipated for the conventional uses 

that will incorporate updated residential exposure 

assumptions and methodologies. 

For triadimenol, there are no residential handler 

exposures from the conventional uses. 

No residential handler exposures are associated with 

the antimicrobial uses of triadimefon. 

Post-application y For triadimefon, residential post-application 

exposures will be assessed for the turf and garden 

uses. 

Post-application exposures (both dermal and hand-tomouth) from the antimicrobial wood preservative use 

of these compounds (e.g., pressure treated play sets 

and decks) will be assessed during registration 

review. 

For triadimenol, there are no residential postapplication exposure scenarios, and so an assessment 

is not anticipated. 

Other 

Aggregate y An updated aggregate risk assessment which takes 

into account the conventional and antimicrobial uses 

of these compounds is anticipated for registration 

review. 

Cumulative N EPA is not currently following a cumulative risk 

approach for the triazole fungicides. However, this 

class of compounds does produce common 

metabolites. The metabolites will be assessed 

separately from the parent compounds in an aggregate 

strategy that takes into account the multiple active 

ingredients involved in their formation and the 

various sources of exposure. 

15 
Tolerances y The Agency notes that confined rotational crop data 

indicate that triadimenol residues may be taken up 

and present in rotational crops. During registration 

review, additional data is anticipated to be required 

that will inform this route of exposure, and the 

Agency will consider the need to establish tolerances 

for inadvertent residues of triadimenol in rotational 

crops. 

During registration review, the Agency will also 

review the tolerance expression (for the conventional 

uses) to insure current format and address issues of 

coverage and compliance. 

The Agency has not established tolerances or 

tolerance exemptions for residues for the 

antimicrobial uses of triadimefon. 

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

updates Triadimefon: Tier I (Scoping) Review of Human 

Incidents and Epidemiology and Triadimenol: Tier I 

(Scoping) Review of Human Incidents and 

Epidemiology. 

16 
TIME LINE 

EPA has created the following estimated time line for the completion of the triadimefon and 

triadimenol registration review in Table 6 below. 

Table 6: Projected Triadimefon and Triadimenol Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period 2016- March 

Close Public Comment 2016 -May 

Case Development 

Final Work Plan 20 16 - August 

Issue DCI 2016 October - December 

Data Submission 2018 October - December 

60-day Public Comment Period for Draft Risk 2020 April- June 

Assessments 19 

Registration Review Decision 

60-day Public Comment Period for Proposed 2021 January- March 

Registration Review Decision 

Registration Review Decision and Begin Post-Decision 2021 

Follow-up 

Total (years) 5 

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 triadimefon and triadimenol. 

19 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. 

17 
Appendix- Additional Areas Considered in the Triadimefon and Triadimenol 

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 ofMRLs 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: 

Triadimefon and triadimenol are not identified as a cause of impairment for any water bodies 

listed as impaired under section 303(d) of the Clean Water Act. 20 In addition, no Total Maximum 

Daily Loads (TMDL) have been developed for triadimefon or triadimenol. 21 More information 

on impaired water bodies and TMDLs can be found at the Agency's website.22 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 Process23 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 triadimefon and triadimenol 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. 

20 http://iaspub.epa.gov/tmdl waters I 0/attains nation cy.cause detail 303d?p cause group id=885 21 http://iaspub.epa.gov/tmdl waters I 0/attains nation.tmdl pollutant detail?p pollutant group id=885&p pollutant 

group name=PESTICIDES 22 https://www.epa.gov/tmdl 23 http://www2.epa.gov/pesticide-reevaluation!opp-guidance-submission-state-and-tribal-water-guality-monitoringdata 

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ENDANGERED SPECIES: 

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

conducted for triadimefon and triadimenol. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether use of triadimefon and 

triadimenol 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 Reregistration Eligibility Decision for Triadimefon and Tolerance 

Reassessment for Triadimenol, 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 ), triadimefon and triadimenol are 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 theE, 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 

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identified for EDSP screening was published on June 14, 2013 24 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. 

Triadimefon 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 ofthose reviews are available in the chemical-specific public dockets, see EPA-HQOPP-2016-0114 for triadimefon; triadimenol was not included on List 1 or List 2. 

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.

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HUMAN STUDIES: 

Chemical-specific Human Studies 

Past triadimefon and triadimenol risk assessments have relied in part on human studies which 

involved intentional exposure to triadimefon and triadimenol. In the course of registration review 

EPA will reconsider these studies, as well as any other research involving intentional exposure of 

human subjects to triadimefon and triadimenol brought to its attention. If EPA decides to rely on 

any of these studies, EPA will ensure that all applicable regulatory requirements are met, 

including, but not limited to, the requirements for EPA ethics review and Human Studies Review 

Board review of certain research involving intentional exposure of human subjects. 

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

chemicals. 25 http://www2.epa.gov/endocrine-disruption 

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