### Docket Number EPA-HQ-OPP-2016-0114 www.regulations.gov



## Triadimefon and Triadimenol Preliminary Work Plan

Approved by:

Da te: 

## 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 TIMELINE
...... . ........... . ...... ... .. ......................... . . ..... . ........... . ... . . . ........ . ... ..... ......................... ......... 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. 26. 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

### ANTI CIPATE D 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 E stimated Conventional Use Guideline Timeframe 

## . Study Title 1 Test (C) or Number 1 (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 crops 2 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 Title 1 Test (C) or N umber 1 (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 pollinators 5 TEP 

# c 24 guideline 850.3040 Full-field testing for pollinators 6 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 te st) 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 applicati on equipment. 9 The wipe study is based on the need to assess dermal and incidental oral exposures to children play ing 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 Indu stry Group
. 6Table 1: Anticipated Data Needs for the Registration Review of Triadimefon Data N eeded for E stimated Conventional U se Guideline Study Title 1 Test (C) or Timeframe Number 1 (Month s from Material Antimicrobial Use (A) receipt of D CI) 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 Title 1 Test Material (C) or (Months from Antimicrobial Use (A) receipt ofDCI) ' 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 sp lit 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 g uideline studies. See " Final Test Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282 , June 27,2012. http :/ /www.regulations.gov/#! documentDetail ; D=E PA-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 Title 1 

### ,_ (C) or Timeframe Number 12 Test Material (Months from**~** Antimicrobial Use (A) receipt ofDCI)**~** 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 line s of data and the need for a refined pollinator risk assessment. 

### 8STATUTORY AND RE GULAT ORY 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. Ta ble 3 : Chemical Facts for Triadimefon and T riadim enol 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. go v/pe sti c id e-reevaluation 9Table 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 oftoxicity. 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 T riadimefon : A permanent tolerance for residues oftriadimefon (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
. T riadimenol: 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.go v, (703) 308-6416 Product Manager



### USE AND USA GE INF ORMATION Table 4 summarizes the use and usage information for triadimefon and triadimenol. Please see the 

### BE AD Chemical Profile (BCP)for Registration Review : Triadimefon (1 

### 09901 ) and Triadimenol (12 7 201 ) in the registration review docket for more details
.

10Table 4: Triadimefon and Triadimenol Us e and Us a ge Information Summary of Use

Summary of U sage Triadimefon : Triadimefon was first registered as a fungicide in the U .S
. in 1968 (USEPA , 2006) and a Triadimefon RED and Triadimenol TRED was published in 2006. Triadimefon was initially registered for food uses , such as apple s, 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 Us e and Us age Inf ormation 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 . Appli cation 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 Crop Science 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 ofparticular 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 90 1 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 U S market. 

### RE CENT AC TIONS 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 label s can be obtained from the Pe sticide Product Label System (PPLS) website (http :/ /oas pub .epa. gov/pe stl ab 1 /ppl s. ho me)
. 12triadimefon 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 RI SK ASSESSMENTS FOR REGI STRATION 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-di sruption
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 Triadim enol: 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 w ater 

### 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.

14Post-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 ofthese 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 .
15Tolerances 

### 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 oftriadimefon. 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 In c ident s and Epidemiology
.

16TIMELINE EPA has created the following estimated timeline 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 pesticide s, 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 FEEDBAC K : 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. 

### Growe rs and oth er stakehold ers are asked to com ment 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 sub miss ion 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 RiskAssessment 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 th at may have aty pical, unusually high exposure compared to th e general populatio n.
20 http ://iaspub .epa .gov/tmdl waters I0/attains nation cy.cause detail 303d?p cause group id= 885 21 http: //iaspub.epa.gov/tmdl waters I0/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 18ENDANGERED SPEC IES: 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. ENDO CRINE 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 ofthe 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 , ofthe 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

19

### 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 ofthese 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 ofthe EDSP, the policies and procedures, the lists of chemicals, future lists , the test guidelines and the Tier 1 screening battery, please visit our website
.2 5 

### 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 ofregistration 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


### 20