Docket Number EPA-HQ-OPP-2015-0602 

www.regulations.gov 

Triticonazole Final Work Plan 

Registration Review 

Case Number 7036 

March 2016 

Approved by: 

Yu-tauilaran 

Director 

Pesticide Re-evaluation Division 

Date: 6/ t S/ I G 
INTRODUCTION 

This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of triticonazole. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the triticonazole registration 

review docket (EPA-HQ-OPP-20 15-0602). Triticonazole is a fungicide in the triazole chemical 

family registered for use on seed treatment for cereal grain crop groups (15 and 16). It is also 

registered for use as a broadcast and spray application on golf course turf, sod farms, 

ornamentals, nursery trees, Christmas trees, and indoor houseplants. 

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. Changes in science, public policy, and pesticide use practices occur over time. 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. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency's website.' 

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received during the public comment period for the PWP concerning anticipated data 

needs, expected risk assessments, or the estimated time line identified in the PWP, and a 

summary of the Agency's responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected 

registration review timeline for triticonazole. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on triticonazole since the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period on the Triticonazole Preliminary Work Plan, which 

opened on October 2, 2015 and closed on December 1, 2015, the Agency received one public 

comment from the FIFRA Endangered Species Task Force (FESTF). The comment did not 

address the time line described in the PWP, the planned ecological and human health risk 

assessments, or the data requirements. In the PWP, EPA also solicited comments on the specific 

topics of environmental justice, water quality concerns, and trade irritants, but no comments or 

information were received on those issues. 

Comments submitted by FESTF in EPA-HQ-OPP-2015-0602-0010. 

Comment: The technical registrant f or triticonazole, as identified on the f act sheet in the 

PWP, is BASF Corporation, which is a FESTF member and is entitled to rely on FESTF 

data. 

1 http://www2.epa.gov/pesticide-reevaluation 

2 
Response: EPA appreciates FESTF's comments and will consider this information during 

registration review. 

PLANNED DATA NEEDS 

Table 1 below summarizes the planned data needs for triticonazole based on the Problem 

Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be conducted 

in Support of Registration Review for Triticonazole and Triticonazole: Human Health 

Assessment Scoping Document in Support of Registration Review. The planned data needs have 

not changed from what was included in the PWP. 

Table 1: Planned Data Needs for the Triticonazole Registration Review 

Estimated 

Guideline Study Title2 

Timeframe 

Number2 Test Material (Months from 

receipt of DCI) 

850.1035 Mysid acute toxicity TGAI 12 

850.2300 Avian reproduction, northern bobwhite TGAI 24 

850.3040 Field testing for pollinators TEP 24 

850.6100 Environmental chemistry methods and associated TGAI 12 independent laboratory validation, water 

850.6100 Environmental chemistry methods and associated TGAI 12 independent laboratory validation, soiP 

Non-GLN 

(OECD Honey bee larvae acute oral toxicity TGAI 12 Test GLN 

237) 

Non-GLN Honey bee larvae chronic oral toxicity TGAI 12 

Non-GLN 

(OECD Honey bee adult acute oral toxicity TGAI 12 Test GLN 

213) 

Non-GLN Honey bee adult chronic oral toxicity TGAI 12 

Non-GLN Residues in pollen and nectar/field residue TEP 24 analysis 

Non-GLN Semi-field testing for pollinators (tunnel or TEP 24 colony feeding studies) 

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

2 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 "Fi nal Test 

Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 2012. 

http://www .regu1ations.gov/#!documentDetai1;D=EP A-HQ-OPPT -2009-0 154-0028 

3 Only the independent laboratory validation portion of this study will be needed for soil. 

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RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent comprehensive human health risk assessment for triticonazole was completed in 

2013 in support of a new use request on outdoor and greenhouse ornamentals. The most recent 

ecological and environmental fate risk assessment was completed in 2013 for the same purpose. 

Findings and conclusions from these risk assessments are summarized in the Problem 

Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be conducted 

in Support of Registration Review for Triticonazole and Triticonazole: Human Health 

Assessment Scoping Document in Support of Registration Review. 

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of triticonazole. For human health, EPA 

will conduct a revised drinking water assessment, and occupational handler and post-application 

exposure risk assessments during registration review. If toxicological endpoints or points of 

departure are revised based on the data that are 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 2 below summarizes the planned registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document. The planned assessments have not changed 

from what was included in the PWP. 

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Table 2: Planned Risk Assessments for the Triticonazole Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecolotdcal and Environmental Fate 

Comprehensive ecological Yes 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

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

updates triticonazole, see page 16 of the Problem 

Formulation. 

Human Health 

Dietary 

Food No A new dietary exposure assessment is not needed 

during registration review unless there are significant 

increases to drinking water exposure estimates. 

Drinking water Yes The need for an updated drinking water assessment 

will be considered during registration review. 

Occupational 

Handlers (mixers, loaders, Yes Needed to account for recent changes in exposure 

applicators) assessment assumptions, including body weight, 

Post -application Yes amount treated, and transfer coefficients. 

Residential 

Handlers No Residential handler and post-application exposure 

Post-application No assessments are not needed. However, the Agency 

will examine the need for volatilization and spray 

drift exposure assessments to bystanders. 

Other 

Aggregate No Evaluates the combined risk from dietary and 

residential exposures. 

New aggregate exposure assessments are not needed 

during registration review, unless changes in uses, 

procedures, or estimated drinking water 

concentrations occur. 

Triticonazole may be considered in an updated 

aggregate drinking water assessment for triazolederivative fungicides. 

Cumulative No Triticonazole has not been identified as a member of a 

cumulative group that shares a common mechanism 

of toxicity. 

Tolerances No 

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Table 2: Planned Risk Assessments for the Triticonazole Registration Review 

Type of Risk Assessment Conduct? Notes 

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

updates triticonazole, see page 9 of the Scoping Document 

and the Triticonazole: Tier 1 (Scoping) Review of 

Human Incidents and Epidemiology 

TIME LINE 

EPA has created the following estimated time line for the completion of the triticonazole 

registration review in Table 3 below. The projected timeline has not changed since the PWP. 

Table 3: Registration Review for Triticonazole- Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period 2015 - September 

Close Public Comment 2015 -December 

Case Development 

Final Work Plan 2016 - March 

Issue DCI 2016 - April-June 

Data Submission 2018- April-June 

60-day Public Comment Period for Draft Risk Assessments4 2019- October-December 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review 2020 - July-September 

Decision 

Registration Review Decision and Begin Post-Decision Follow-up 2021 

Total (years) 6 

NEXT STEPS 

As noted previously, the Agency plans to require several environmental fate and ecological 

effects studies for triticonazole through a Data Call-In Notice, expected to be issued later in 

2016. 

4 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. 

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