2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review of etridiazole. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the etridiazole registration review docket (EPA-HQ- OPP-2014-0414) . Etridiazole is a soil fungici de in the thiazole family registered for use to control primarily Pythium and Phytophthora soil water mold species.
Etridiazole is also used to control bacteria in genus Nitrosomonas . Etridiazole is registered for use on field cotton, turf (golf c ourses), nursery stock, tobacco fl oat bed seedling treatments, and greenhouse ornamentals as well as for mixing in potting soil for commercial greenhouse use. In addition, etridiazole has been approved for certain Special Local Need (S LN) greenhouse uses on tomatoes. There are currently no regist ered residential uses for etridiazole.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. Changes in scienc e, public policy, and pesticide us e practices occur over time. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard. The public phase of registration review begins wh en the initial docket is opened for each case. Information on this program is provided on the Agency’s website. 1

The FWP begins with any updates since the PWP wa s issued. Next is a summary of substantive comments received during the public comment peri od for the PWP concerning anticipated data needs, expected risk assessments, or the estimated timeline identified in the PWP, and a summary of the Agency’s responses to those comme nts. This section is followed by registration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for etridiazole. La stly, there is a discus sion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on etridiazole since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Etridiazole Preliminary Work Plan, which opened on June 25, 2014 and closed on August 25, 2014, the Agency received six public comments. Regional data on the use and usage of etridiazole are provided by the College of Tropical Agriculture and Human Resources of the University of Hawai‘i at M ā noa (EPA-HQOPP-2014-0414-0011) and the Western Integrated Pest Management Center (EPA-HQ-OPP2014-0414-0014). Data are offered rela ting to the potential effects of etridiazole on threatened and endangered species by the Center for Biological Diversity (EPA-HQ-OPP-2014-0414-0009) and FIFRA Endangered Species Task Force (F ESTF) (EPA-HQ-OPP-2014- 0414-0012). A letter from the Physicians Committee for Responsible Me dicine asked EPA to limit the use of testing on live animals where possible, and comments by registrant MacDermid Ag ricultural Solutions,

1 http://www.epa.gov/oppsrrd1/registration_review/3 Inc. outlined a proposal for how the company intends to satisfy the Agency’s list of planned data
needs. The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data re quirements. 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.

This section does not capture every comment made about the PWP nor all of the Agency’s responses. No public comments resulted in change s to the anticipated re gistration review data needs, risk assessments, or timeline from those outlined in the etridiazole PWP. Public comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP-2014- 0414. Summarized public comments and Agency re sponses related to the anticipated ecological
risk assessment or data need s are included in the document Response to the Initial 60-Day Public Comment on: “Registration Review: Draft Pr oblem Formulation for Environmental Fate, Ecological Risk, Endangered Species and Human Health Drinking Water Exposure Assessments for Etridiazole (05/06/14; PC Code 084701; DP Barcode 417576). ” The Agency thanks all
commenters and will consider the information su pplied by them as EPA conducts its registration
review of etridiazole.4 PLANNED DATA NEEDS

Table 1 below summarizes the planned da ta needs for etridiazole based on the Registration Review: Draft Problem Formula tion for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Wate r Exposure Assessments for Etridiazole

, Etridiazole Human Health Risk Assessment Scoping Do cument in Support of Registration Review, and the response to public comments document Response to the Initial 60-Day Public Comment on: “Registration Review: Draft Problem Formulati on for Environmental Fa te, Ecological Risk, Endangered Species and Human Health Drinking Water Exposure Assessments for Etridiazole (05/06/14; PC Code 084701; DP Barcode 417576). ” The planned data needs have not changed
from what was included in the PWP. As the Agency works toward implementing its Guidance for Assessing Pesticide Risks to Bees 2 , additional data may be requi red for etridiazole to assess non-target exposure to bees.

Table 1: Planned Data Needs for the Etridiazole Registration Review

Guideline

Number 3 Study Title Test
Material Estimated

Timeframe

(Months from receipt of DCI)

Planned Data Needs for the Parent Etridiazole

835.4300 Aerobic aquatic metabolism TGAI 24 835.4400 Anaerobic aquatic metabolism TGAI 24

850.1350 Mysid chronic toxicity test TGAI 12

850.1400 Fish early life stage toxicity test (estuarine/marine only) TGAI 12

850.1500 Freshwater fish life cycle toxicity test TGAI 24

850.2100 Avian acute oral toxicity (passerine species) TGAI 12

850.3020 Honeybee acute contact toxicity TGAI 12

850.4100 Terrestrial plant toxicity, seedling

emergence TEP 12

850.4150 Terrestrial plant toxi city, vegetative vigor TEP 12

850.4400 Aquatic plant toxicity test (using Lemna

ssp. ) TEP 12

850.6100 Environmental chemistry methods and associated independent laboratory
validations 4 TGAI 12

2 Guidance is available at: http://www2.epa.gov/sites/ production/files/2014- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

. 3 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 Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

4 An ECM and ILV are planned as needed for soil and water.5 Table 1: Planned Data Needs for the Etridiazole Registration Review

Guideline

Number 3 Study Title Test
Material Estimated

Timeframe

(Months from receipt of DCI)

875.2100 Dislodgeable foliar residue and turf
transferable residues 5 TEP 24

NonGuideline Honeybee acute oral toxicity 6 TGAI 12

NonGuideline Honeybee larval toxicity 7 TGAI 12

Planned Data Needs for Degradate 3-Carb-T 850.1010 Acute toxicity (freshwate r invertebrates) TGAI 12 850.1075 Fish acute toxicity test (freshwater) TGAI 12
Planned Data Needs for Degradate 3-DCMT 850.1075 Fish acute toxicity test (estuarine/marine) TGAI 12
TGAI = technical grade active ingredie nt; 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 a ssessment, for all uses of etri diazole. For human health, EPA
will conduct revised residential (non-occupational) and occupational risk assessments during registration review. If toxico logical endpoints or points of de parture 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 registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Docume nt and the planned assessments have not changed from what was included in the PWP.

5 A turf transferrable residue study is planned as a data requirement.

6 E.g ., OECD 213.

7 E.g. , OECD 237. The planned DCI will require protocol submission prior to study initiation.6 Table 2: Planned Risk Assessments fo r the Etridiazole Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Yes Degradates 3-Carb-T and 3-DCMT will be considered major degradates and will be characterized in the ecological risk assessment.

Incidents Will check for updates For a discussion of reporte d ecological incidents for etridiazole, see page 15 of the Problem Formulation. A search run on March 25, 2014 of the Office of Pesticide Program’s internal database Ecological Incident Information System (EIIS) identified no ecological incident reports for etridiazole.

Human Health Dietary Food No A new dietary assessme nt may be performed if 1) there are any significant changes to toxicological points of departure (PODs) or uncertainty factors, 2) EFED determines that new estimated drinking water concentrations (EDWCs) are necessary using updated models, or 3) residue chem istry review results in recommendations for significantly higher tomato tolerances than currently established. Drinking water No

Occupational Handlers (mixers, loaders, applicators) Yes Updated quantitative handler and post-applicationoccupational risk assessments (cancer and noncancer) will be performed to include updated exposure assessment methodology, and any revisions to toxicological PODs or uncertainty factors. An occupational risk assessment should be performed for the SLN greenhouse tomato use. The new chemical specific greenhouse handler exposure data may be
considered for use in certain handler assessments. Post-application Yes

Residential (Non-Occupational)

Handlers No A residential handler exposure assessment is not required because etridiazole is only applied to use sites that are not treated by residential handlers; there
are no homeowner uses.7 Post-application Yes Etridiazole is pr ohibited from use on residential turf and lawns. However, as etridiazole may be used on golf course turf, adults and children may experience post-application dermal expos ure to etridiazole as aresult of golfing activities. An updated postapplication assessment for golfers on etridiazole treated turf will be pe rformed under registration review since there have been significant changes in exposure assessment methodology since the last assessment (updated 2012 residential SOP).

Other Aggregate No Revised aggregate risk assessments may be performed for etridiazole if there are any significant changes to toxicological PODs or uncerta inty factors, or if there are significant changes to dietary exposure estimates, or if there are significant changes to post-application golfer exposure estimates (based on the 2012 SOPs and on any new TTR data), or if EPA’s
Environmental Fate and E ffect Division (EFED) has determined that new estimated drinking water concentrations (EDWCs) are necessary.

Cumulative No Etridiazole is not a member of a cumulative group and no cumulative risk assessment is planned.

Tolerances Yes Tolerances for etri diazole are established in 40 CFR§180.370. The tolerance for tomatoes will be reevaluated based on the residue data submitted (since the RED) for imported tomatoes. The tolerance expression will be revised to reflect current policy. There are currently no inte rnational maximum residue limits (MRLs) for etridiazol e; therefore, there are no harmonization issues with Codex, Canada, or Mexico. Currently all tomato uses of etridiazole are Special Local Need (SLN) uses rather than Section 3 registrations.

Incidents Will check for updates For a discussion of reported human incidents for etridiazole, see page 15 of the Scoping Document and
the Terrazole: Tier I Review of Human Incidents

.8 TIMELINE

EPA has created the following estimated timeline for the completion of the etridiazole registration review in Table 3 below. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Etridiazole – Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2014 – June Close Public Comment 2014 – August Case Development

Final Work Plan 2014 – November

Issue DCI 2015 Jan. - March

Data Submission 2017 Jan. - March 60-day Public Comment Period for Draft Risk

Assessments 8 2018 July – Sept.

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 April - June

Registration Review Decisi on and Begin Post-Decision Follow-up 2020

Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to requir e several environmental fa te, ecological effects,
and human health studies for etri diazole through a Data Call-In Notic e, expected to be issued in early 2015.

8 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.