DocketNumber EPA-HQ-OPP-2012-0413 www.regulations.gov



# Triphenyltin Hydroxide (TPTH) Final WorkPlan Registration Review Case Number 99
May2013

Approved by:

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Date: Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Division

### INTRODUCTION This is the Environmental Protection Agency's (EPA orthe Agency) Final Work Plan (FWP) for the registration review oftriphenyltin hydroxide (TPTH), also known as fentin hydroxide. This workplan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the TPTH registration review docket (EPA-HQ-OPP-2012-0413). TPTH is a non-systemic foliar fungicide registered for use to control early and late blight onpotatoe.s; Colorado potato beetle and leafspot on sugarbeets; and scab, brown leafspot and other diseases onpecans. In addition to its fungicidal activity, TPTH exhibits anti-feeding properties for surface-feeding in.sects. There are no registeredresidential uses, and TPTH products are used primarily in agricultural areas. The Agency is implementing the registration reviewprogram 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 overtime. The registrationreviewprogram is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meetthe statutory standard. The public phase ofregistration reviewbegins when the initial docket is opened for each case. Information onthis program is provided onthe Agency's website. 1
The FWP begins with any updates since the PWP was issued. Next is a summary ofsubstantive comments received during the public commentperiod for the PWP concerning anticipated data needs, expected risk assessments, orthe estimated timeline identified in the PWP, and a summary ofthe Agency's responses to those comments. This section is followed byregistration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for TPTH. Lastly, there is a discussion ofnext steps. 

### UPDATES SINCE THE PWPWAS ISSUED Based oncomments provided by the Physicians' Committee for Responsible Medicine after the PWP was issued, and considering submitted immunotoxicity studies in rats and mice as well as data available in the published literature, the Agencyhas determined thatthe anticipated data requirement in the PWP for an immunotoxicity study (GLN 870.7800) is no longer required. As a result, in the TPTH FWP, the immunotoxicity study has beenremoved from the list of anticipated datarequirements in Table 1. 

### SUMMARY OF COMMENTS AND AGENCY RESPONSES Duringthe 60-daypublic commentperiod onthe TPTH PWP, which opened onDecember 12, 2012 and closed on February 12, 2013, the Agency received two comments. Comments were submitted bythe FIFRA Endangered Species Task Force (FESTF) and the Physicians Committee for Responsible Medicine (PCRM). The comments do not address the timeline described in the PWP, butthey do address the plannedecological andhuman healthrisk assessments and data requirements. Inthe PWP, EPA also solicited comments onthe specific topics ofenvironmental

1http:Ilwww.epa.govI**opp~rrd**1/registration _reviewI 2

### justice, water quality concerns, and trade irritants, butno comments or information were received on those issues. Summarized below are public commentsthat resulted in changes to the anticipated registration review data needs, or are ofa broader regulatory nature. Public comments and EPA responses in their entirety are located inthe docket, EPA-HQ-OPP-2012-0413. Agency responses related to the anticipated data needs are in the EPA Health Effects Division (HED) memo titled TPTH (I'riphenyltin Hydroxide). Response to Comments; Recommendation for Immunotoxicity Study Waiver. Commentsubmitted by FESTF in EP A-HQ-OPP-2012-0413-0009: 

### 1. Comment: "The technical registrants, as identifiedon thefact sheet includedin the Registration Review Summary, include Bayer CropScience andNufarmAmericas, Inc., which are FESTFmembers andare entitledto rely on FESTFdata. " 

### Response: The Agency thanks FESTF for the comment and will considerthis information during registration review. Comment submitted by PCRM in EPA-HQ-OPP-2012-0413-0010: 

### 2. Comment: "Regarding the Immunotoxicity data request, we found four studies that may be useful in the riskassessmentprocess. We encourage theAgency to waive the request for a newImmunotoxicity study for TPTHbasedon the dataprovidedby these studies. " 

### Response: The Agency has determined that the requirement for an immunotoxicity study has been satisfied based on submitted immunotoxicity studies in mice and rats as well as the data available in the published literature.



### 3PLANNED DATANEEDS Table 1below summarizes the planned data needs for TPTH based onthe Registration Review: PreliminaryProblem Formulationfor Environmental Fate, EcologicalRisk, Endangered Species, andHuman Health Drinking Water ExposureAssessments for Triphenyltin Hydroxide (I'PTH), the TPTH (I'riphenyltin Hydroxide). Health Effects Division (HED) ScopingDocument for RegistrationReview, and the TPTH (I'riphenyltin Hydroxide). Response to Comments; Recommendation for Jmmunotoxicity Study Waiver. The table has been updated sincethe PWP to reflect public comments which resulted in changes to the data needs.
Table 1: Planned Data Needs for the TPTH Registration Review Estimated Guideline Timeframe Number Study Title Test Material (Months from

(GLN) receiptofDCI)
835.4100 Aerobic Soil Metabolism2 TGAior 24 PAIRA 850.1300 Aquatic Invertebrate Life Cycle (freshwater) TGAI 12 850.1350 Aquatic Invertebrate Life Cycle (saltwater) TGAI 12 850.1400 Fish Early-Life Stage (saltwater) TGAI 12 850.2100 Avian oral toxicity (passerine species) TGAI 12 Environmental Chemistry Methods and Associated 850.6100 Independent Laboratory Validation for soil and water3 TGAI 12
The study listed below was previously required through a generic data call-in (GDCI-083601-17847), issued in November 1999, received in January 2001, and is currently under EPA review. This study is listed in this document as background; it will NOT be included in the anticipated Registration Review DCI as it is already required through the earlier DCI. 835.1230 (listed as Adsorption/Desorption TGAI or Under EPA 163-1 in (Batch Equilibrium) 4 PAIRA review 1999 GDCI) TGAI = techmcal grade act1ve mgred1ent; TEP = typical end-use product; PAIRA = pure act1ve mgred1ent radiolabeled;

2 Since acceptable aerobic soil metabolism data on two soils out ofthe four soils required in GLN 835.4100 have been submitted to EPA previously, acceptable data on two more soils are required. Soils should be representative ofsoils on which TPTH use is expected to occur. Ifa foreign soil is used, it must be demonstrated to be comparable to a U.S. soil. Registrants should consult the guideline 835.4100 for further guidance. 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 ofAvailability" 77 FR 38282, June 27, 2012

. http:/ /www.regulations.gov/ #!documentDetaii:D=EPA-HO-OPPT-2009- 0154-0028 4 The 1999 GDCI stated the following: "Adsorption/desorption studies are required in order for the Agency to perform environmental fate assessments

. The submitted adsorption/desorption study was a thin-layer chromatography (TLC) study, which does not provide Kds, which are necessary for fate assessments. A batch study is required."
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### RISKASSESSMENTS FORREGISTRATION REVIEW During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses ofTPTH. Forhuman health, EPA will conduct revised dietary and occupational risk assessments during registration review. If toxicological endpoints orpoints of**~eparture** 

### are revised based onthe data that are required for registration review, they will be considered in the new assessments, as will any changes to the standard operatingprocedures or default exposure assumptions. Table 2 below summarizes the planned registration**r~view** 

### risk assessments based on the EFED Problem Formulation and HED Scoping Document. The planned assessments have not changed from what was included inthe PWP.


### Table 2: Planned RiskAssessments for the TPTHRegistration Review



## - Type ofRiskAssessment Conduct? Notes 

## Eeoio&iiilf iict·' EnvirC»iimentaiFate .· 

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### Comprehensive ecological y 

### The Agency plans to evaluate risks to nontarget (species to be 

### assessed terrestrial and aquatic organisms, including Federallyinclude terrestrial and aquatic listed threatened and/or endangered species. organisms), including endangered species Incidents Will check for For a discussion ofreported ecological incidents for updates TPTH, see page 14 ofthe Problem Formulation. 

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## ...' :;•, Dietary Food y 

### The Agency anticipates conducting a revised dietary risk assessment. Drinking water y 

### The Agencyplans to conduct a drinking water exposure assessment for TPTH. Occupational Handlers (mixers, loaders, y 

### The Agency anticipates conducting a revised applicators) occupational exposure and risk assessment during registration review. Post-application y 

### The Agency anticipates conducting a revised assessment for post-application exposures from TPTH. The need for a bystander inhalation risk assessment for TPTH also will be examined. Residential Handlers, post-application, TPTH is not registered for use in residential settings. incidental oral, and N 

### Therefore, a residential exposure assessment is not recreational required. Other

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### Aggregate 

### y Evaluates the combined risk from dietary and residential exposures. Since there are . no residential uses ofTPTH, the aggregate risk estimate will be equivalentto the dietary risk estimate. Cumulative N TPTH is not a member ofa cumulative group and no cumulative risk assessment is planned. Tolerances 

### y The tolerance expression will be revised to ensure that it appropriately covers the metabolites and degradates ofTPTH and that it specifies the residues to be measured for each commodity. Incidents Will check for For a discussion ofreported human incidents for updates TPTH, see page 8 ofthe Scoping Document and the TPTH (Fentin Hydroxide):Review of Human Incidents.



### TIMELINE
EPA has created the following estimated timeline for the completion ofthe TPTH registration review in Table 3 below. The projectedtimeline has not changed since the PWP.
Table 3: Registration Review for TPTH- Projected Registration Review Timeline Activities Estimated Date Openingthe Docket Open Docket and Open 60-day Public Comment Period for PWP and December 2012

- Supporting Documents ComQleted Close Public Comment



## - February 2013

- Completed Case Development 

# . Issue Final Work Plan May2013- Completed Issue DCI 2014- Jan- March Data Submission 2016- Jan- March Open 60-day Public Comment Period for Draft

### RiskAssessments;) 2017- July- Sept. Registration Review Decision Open 60-day Public Comment Period for Proposed Registration Review 2018- Jan- March Decision Issue Registration Review Decision and Begin Post-Decision Follow-up 2018 Total (years) 6

5 The regulations governing Registration Review generally require the Agency to provide a public comment period

ofat least 30 calendar days for draft risk assessments; see 40 CFRPart 155.53(c). For conventional pesticides, the Agencyplans to provide a 60 calendar day public comment period generally for draft risk assessments. 

### 6NEXT STEPS 

### As noted previously, the Agency plans to require several environmental fate and ecological effects studies for TPTH through a Data Call-In Notice, expectedto be issued in 2014.

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