### 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) ofthe 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 timeline 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 triticonaz ole. 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 th e 60-day public comment p eriod on the Triticonazole Pre limin ary Work Pl an , 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 timeline 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 top ic s of environmental justice , water qu ality conc erns , and trade irritants , but no comments or informati o n w ere re ce ive d on tho se i ss u e s. Comments submitted by FESTF in EPA-HQ-OPP-2015-0602-0010. C omment: Th e tec hn ical reg i s trant fo r triticonaz ole , as identified on t h e fa ct sh ee t in th e P WP, is B ASF Corp or a tion, whic h i s a FE S TF m e mb e r and is entitled to re l y on FESTF da t a .

1 http: //www 2

. ep a.g ov/pe sti c id e -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 Formulationfor 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 Title 2 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 pollinator s 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 ora l 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 guide line 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/#!documentDetai 1;D = EP A-HQ-OPPT-2009-0 154-0028 3 Only the independent laboratory validation portion of this study will be needed for soil. 3

### 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 Formulationfor the Ecological Risk and Drinking Water Exposure Assessments to be conduct ed in Support of Regis tration R eview for Triti c onazole and 

### Triticonazole : Human Health A ssessment Scoping Document in Support of Regis tration 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 , the y will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions. T able 2 below summarizes the planned registration review risk assessments b a sed on the EFED Problem F ormulation and H E D Scoping Document. The planned assessments have not chang ed from what was included in the PWP.

4Ta b le 2: Pla n ned Risk Assess m ents for the Triticonazole Registration Review Type of Risk Assess m ent Conduct? Notes E colotdcal and Environmental Fate Co mprehensi v e 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. H uman 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 bod y weight , Post-application Yes amount treated , and transfer coefficients. Resi dential Handlers No Residential handler and post

- application exposure Post-application No assessments are not needed. However , the Agenc y will examine the need for volatilization and spray drift exposure assessments to bystanders. Other Ag gregate No E valuates the combined risk from dietary and residential exposures . New aggregate exposure assessments are not needed during registration review , unless changes in use s , 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 o f 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) R e view of Human Incidents and Epid emiology 

### TIMELINE EPA has created the following estimated timeline 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 W or k Plan 2 016

- March I ssue D CI 20 1 6

- April-June D ata Submission 2018- April-June 60-day Public Comment Period for Draft Risk Assessments 4 2019- October-December Registration Review Decision 60-day Publ i c C omment Period for Proposed Registration Re v iew 20 20

- Jul y -September D eci s i o n R eg i stration R evie w D ecision and B eg in Post-Decision F ollow-up 2 0 2 1 Total (years) 6 

### NEXT STEPS As n ote d p revi ou s ly , the A ge nc y pl an s to require s everal en vironmental fate and ecol og ic al effects studies for triticonazole through a Data Call-In Notice , expected to be issued later in 2016

.

4 T he regul ati o n s gove rnin g Reg is trati o n Revi e w ge n era ll y re quire th e Age nc y to prov ide a p ubli c co mm e nt p eriod

o f at leas t 30 calendar d ays for draft ri s k assess me nts ; see 40 CF R Part 1 55.53 (c)

. For co nve nti o n a l p es ti c id es , the Age n cy pl an s to pr ovide a 6 0 ca le nd ar d ay publi c co mment p eriod ge nera lly fo r draft ri s k as s ess m e nt s . 6