Docket Number EPA-HQ-OPP-20 15-0061 

www.regulations.gov 

Tetraconazole Final Work Plan 

Registration Review 

Case Number 7043 

February 2016 

Approved by: 

Date: 

Yu-Ti g Guilaran, Director 

Pesticide Re-evaluation Division (7508P) 

Office of Pesticide Programs 

US Environmental Protection Agency 

Phone: 703-308-8157 
INTRODUCTION 

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

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

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

review docket (EPA-HQ-OPP-2015-0061). Tetraconazole is a demethylation inhibiting (DMI) 

fungicide registered for use on soybeans, sugar beets, corn (field, pop), peanuts, and pecans, to 

control Cercospora blight, frogeye leaf spot, powdery mildew, brown spot, and anthracnose. It is 

also registered for some crops in the crop subgroups 13-07F (small fruit vine climbing subgroup, 

except fuzzy kiwifruit) and 13-070 (low growing berry subgroup, excluding cranberry). 

Currently, there are no registered non-agricultural uses for tetraconazole. 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 sections discussing any updates since the PWP was issued, comments 

received during the public comment period for the PWP, and agency responses. These sections 

are followed by registration review planned data needs, risk assessments expected to be 

conducted, and the projected registration review timeline for tetraconazole. Lastly, there is a 

discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

Since the PWP, the agency received a new use petition for fruiting vegetables (crop group 9 and 

I 0), cucurbit vegetables group (crop group 9) and revising tolerances for sugar beets for 

tetraconazole, in September 2015 . In the PWP, guideline 875.2100 was cited as a data need but 

the data were required as a condition of registration. Because it was previously conditionally 

required, this data requirement will not be included in the FWP or the registration review Data 

Call-In Notice (DCI). The data have been submitted and undergoing review. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

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

opened on September 30, 2015, and closed on November 30,2015, the Agency received no 

public comments. 

PLANNED DATA NEEDS 

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

2 
Table 1 below summarizes the planned data needs for tetraconazole based on the Registration 

Review: Preliminary Problem Formulation for Environmental Fate Ecological Risk, 

Endangered Species, and Drinking Water Exposure Assessments for Tetraconazole and 

Tetraconazole, Human Health Risk 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 Tetraconazole Registration Review 

Estimated 

Guideline Timeframe 

Numbe.-2 Study Title 

Test Material (Months from 

receipt ofDCI) 

Anticipated Data Needs for the Parent Tetraconazole 

835.4200 Anaerobic soil metabolism3 TGAI 24 

835.4400 Anaerobic aquatic metabolism4 TGAI 12 

860.1380 Storage stability in soil and water TGAI 12 

Environmental Chemistry Methods and TGAI 850.6100 Associated Independent Laboratory Validation 12 

(soil and water) 

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12 

850.1400 Fish early-life stage (saltwater) TGAI 12 

850.4100 Terrestrial plant toxicity, seedling emergence TEP 12 

850.4150 Terrestrial plant toxicity, vegetative vigor TEP 12 

850.1500 Fish life cycle (freshwater) TGAI 24 

850.4500 Algal toxicity (freshwater green alga, freshwater TGAI 12 

and marine diatom) 

850.4550 Cyanobacteria (Anabaenajlos-aquae) toxicity TGAI 12 

850.2100 A vi an oral toxicity (passerine) TGAI 12 

Whole sediment-chronic (Two freshwater 

Non- amphipods, Hyalella azteca and Chironomus TGAI 12 

guideline tentans, and one estuarine/marine amphipod, 

Leptoche irus plumulosus). 

Non- Honeybee adult chronic oral toxicity TGAI 12 

guideline 

Non- Honeybee larval acute and chronic oral toxicity TGAI 12 

guideline 

Non- Semi-field testing for pollinators5 TEP 24 

guideline 

2 On June 27, 20 12, EPA announced certain revisions in harmonized guideline series 850 - Ecologica l Effects Tests 

- including renumbering and other designations or changes for some guideline studi es. See " Final Test 

Guidelines; OCS PP 850 Series; Notice of Availability" 77 FR 38282, June 27,20 12. 

http://www .regulations. gov/# ! documentDetai I; D=EP A-1-10-0PPT -2009-0 154-0028 3 Four soil systems 4 One additiona l water/sed iment system 

3 
Table 1: Planned Data Needs for the Tetraconazole Registration Review 

Estimated 

Guideline Study Title 

Timeframe 

Number Test Material (Months from 

receipt of DCI) 

850.3040 Field testing for pollinators5 TEP 24 

Non- Residues in pollen and nectar5 TEP 24 guideline 

Prior Data Required as Conditions of Registration for Tetraconazole 

875.2100 Dislodgeable foliar residue and turf transferable TGAI 

7/21/2015 

residues6 (Received) 

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

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

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

including an endangered species assessment, for all uses oftetraconazole. For human health, 

EPA will conduct revised dietary, occupational, and aggregate risk assessments during 

registration review. If toxicological endpoints or points of departure are revised based on data 

received during 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. 

5 Pending review of lower Tier studies. 6 This guideline data requirement is based on the conditions of registration ; therefore, it will not be included in the 

registration review data call-in. 

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Table 4: Planned Risk Assessments for the Tetraconazole Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y The Agency will conduct a comprehensive ecological 

including endangered species assessment, including an endangered species 

assessment. 

Incidents Will For a discussion of reported ecological incidents for 

check for tetraconazole, see page 14 ofthe Problem Formulation. 

updates There are currently no ecological incidents reported for 

tetraconazole. 

Human Health ,, ' 

Dietary 

Food y As part of the registration review, the dietary risk 

assessment may be revisited. 

Drinking water y Concentrations in drinking water will be reevaluated as 

part of registration review. 

Occupational 

Handlers (mixers, loaders, y Occupational handler and post-application dermal and 

applicators) inhalation assessments will be revised to reflect all 

Post-application y potential exposure scenarios, updated policies, exposure 

data, and any updated toxicological PODs. 

Residential 

Handlers N Tetraconazole is not used in residential settings, so a 

residential handler assessment is not needed. 

Post-application N Tetraconazole is not used in residential settings. A 

conventional residential post-application assessment is 

not needed. The need for drift and volatility 

assessments will be considered during registration 

review. 

Other 

Aggregate y A revised aggregate assessment may be required to 

reflect revised dietary exposure estimates and/or 

changes to the toxicological PODs. 

Cumulative N Tetraconazole is a member of the triazole-containing 

class of pesticides. Structural similarities do not 

constitute a common mechanism of toxicity and there is 

currently no evidence to indicate that members of this 

class share a common mechanism of toxicity. 

Tolerances y The Agency will revisit the tolerances during 

registration review. 

Incidents Will For a discussion of reported human incidents for 

check for tetraconazole, see page 1 1 of the Scoping Document and 

updates the Tetraconazole: Tier I (Scoping) Review of Human 

Incidents. 

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TIMELINE 

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

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

Table 5: Proj ected Tetraconazole Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period September-20 15 

Close Public Comment November-20 15 

Case Development 

Final Work Plan February-20 16 

Issue DCI April-June -2016 

Data Submission April-June -2018 

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

Assessments 7 

Registration Review Decision 

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

Registration Review Decision 

Registration Review Decision and Begin Post-Decision 2021 

Follow-up 

Total (years) 6 

7 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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NEXT STEPS 

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

and human health studies for tetraconazole through a Data Call-In Notice, expected to be issued 

in between April and June of2016. 

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