2 

### TPTH Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessments for Registration Review 7

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in TPTH’s Registration Review 10

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Triphenyltin Hydroxide (TPTH)

. Milians and Sayer. November 29, 2012.

2. TPTH (Triphenyltin Hydroxide). Health Ef fects Division (HED) Scoping Document for Registration Review. Sahafeyan, McCarroll, and Bobowiec. December 4, 2012.

3. BEAD Chemical Profile for Registration Revi ew: Triphenyltin Hydroxide (TPTH) also Known as Fentin Hydroxide (083601). Chandgoyal, Doucoure, and Faulkner. June 25,

2012.

4. TPTH (Fentin Hydroxide): R eview of Human Incidents . Recore. July 19, 2012.

These and other supporting documents for the TPTH registration review case may be found in the docket EPA-HQ-OPP-2012-0413 at http://www.regulations.gov

.3 OVERVIEW

The docket for triphenyltin hydroxide (TPTH), al so known as fentin hydroxide, is now open, initiating the first public comment period for th is registration review (docket number EPA-HQOPP-2012-0413). TPTH is a non-systemic foliar fungici de registered for use to control early and late blight on potatoes; Colorado potato beetle and leaf spot on s ugar beets; and scab, brown leaf spot and other diseases on pecans. In additi on to its fungicidal activity, TPTH exhibits antifeeding properties for surface-feeding insects. There are no registered residential uses, and TPTH products are used primarily in agricultural areas. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pe sticide Programs knows about TPTH, highlighting anticipated data and assessment needs, identify ing the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing TPTH’s review.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t TPTH and what types of new data or other information would be helpful for the Agency to r eceive as it moves toward a decision on TPTH. The Agency encourages all interested stakehol ders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision-making process for this chemical. In addition to gene ral areas on which persons may wish to comment,

there are some areas identified in the PWP a nd Appendix about which the Agency specifically

seeks comments and information. Interested st akeholders could include : environmental nonprofit or interest groups; pesticide manufacturer s; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pestic ides; or the public at large.

The Preliminary Work Plan begins by listing th e anticipated data need s for TPTH. Next, it discusses the statutory and regul atory authority for Registration Review. Then the document provides TPTH’s chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix to this

document includes identification a nd discussion of some areas that are considered generally in Registration Review along with some addi tional chemical case-specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipa ted data needs for TPTH. For additional discussion of the anticipated data needs, see the Registration Review: Prelimin ary Problem Formulation for Environmental Fate, Ecological Risk, Endangere d Species, and Human Health Drinking Water Exposure Assessments for Tri phenyltin Hydroxide (TPTH) and TPTH (Triphenyltin Hydroxide). Health Effects Division (HED) Scopi ng Document for Registration Review

.

Table 1: Anticipated Data Needs for TPTH’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism TGAI or

PAIRA 24

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

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation for soil and

water 1 TEP 12

870.7800 Immunotoxicity TGAI 12
The study listed below was previously required th rough a generic data call-in (GDCI-083601-17847), issued in November 1999, and is still outstanding. Th is study is listed in this document as background;

it will NOT be included in the anticipated Registration Re view DCI as it is already required through the
earlier DCI.

835.1230 (listed as

163-1 in

1999 GDCI) Adsorption/Desorption (Batch Equilibrium) 2 TGAI or

PAIRA due 11/2000

TGAI = technical grade active ingredient; PAIRA = pure active ingredient radiolabeled; TEP = typical end-use product

1 On June 27, 2012, EPA announced certain revisions in harmoni zed guideline series 850 – Ecological Effects Tests – including renumbering and other designations or ch anges for some guideline studies. See “F inal Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!doc umentDetail;D=EPA-HQ-OPPT-2009-

0154-0028

2 The 1999 GDCI stated the following: “Adsorption/desorption st udies are required in order for the Agency to perform environmental fate assessments. The submitted adsorption/desorpti on study was a thin-layer chroma tography (TLC) study, which does not provide Kds, which are necessary for fa te assessments. A batch study is required.”5 STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website 3

.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses

and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of TPTH.

Table 2 provides a summary of the cu rrent regulatory status of TPTH.

Table 2: TPTH Chemical Facts

PC code 083601

Case Number 99

CAS Number 76-87-9 Year first registered 1979 Pesticide Type Fungicide

Chemical class Conventional chemical Reregistration Eligibility Decision (RED) September 1999

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable

40 CFR Citation Tolerances for TPTH are established in 40 CFR 180.236 Dual-use Conventional pesticidal uses only Non-pesticidal uses No non-pesticidal uses of TPTH

3 http://www.epa.gov/oppsrrd1/registration_review/6 Pesticide Re-evaluation Division, Chemical Review Manager Susan Bartow, bartow.susan@epa.gov, 703-603-0065

Registration Division, Product Manager Tony Kish, kish.tony@epa.gov, 703-308-9443

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for TPTH. Please see the BEAD Chemical Profile for Registration Review : Triphenyltin Hydroxide (TPTH) also Known as Fentin Hydroxide (083601) in the registration review docket for more details.

Table 3: TPTH Use and Usage Information

Summary of Use TPTH is a non-systemic foliar fungicide registered for use on agricultural crops. TPTH belongs to a class of chemicals that inhibits oxidative phosphorylation and fungal growth. In addition to itsfungicidal activity, TPTH exhibits anti-feeding properties for surfacefeeding insects. TPTH is registered for use on pecans primarily for control of scab, brown leaf spot, and other diseases. For potatoes, TPTH is registered for use to control early and late blight. For sweet potatoes, TPTH is registered for use to control Colorado potato beetle and leaf spot.

Use Sites TPTH is registered for use on pecans, potatoes, and sugar beets. It is not registered for non-agri cultural/residential use. Summary of Usage During the years of 2006-2010, on average, approximately 230,000 pounds of TPTH were reported to have been used to treat 950,000

acres. Formulation Type(s) TPTH is formulated as a wettable powder and flowable concentrate. Application Method(s) Products can be appl ied by ground and aerial spraying, as well as chemigation (irrigation supply water system). Technical Registrant(s) Bayer CropScience; Nufarm Americas, Inc.; and United Phosphorus, Inc. No. of Registrations 10 Section 3 products 4 and 8 Section 24(c) products.

Restricted Use Yes

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Confirmation of the maximum application rate of active ingredient per season for pecans, potatoes, and sugar beets.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

4 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).7  Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Application timing (date of firs t application and application in tervals) – national, state, and county.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrant s not listed above who supply technical TPTH to the US

market.

RECENT ACTIONS

On October 8, 2009, the Agency included TPTH on the third Contaminant Candidate List (CCL 3) issued since the Safe Dri nking Water Act (SDWA) amendments of 1996. The CCL 3 is a list

of contaminants that are curren tly not subject to any proposed or promulgated national primary drinking water regulations, that are known or anticipated to occu r in public water systems, and which may require regulation under SDWA (FRL 51850).

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for TPTH was completed in September 1999 in preparation for the Reregist ration Eligibility Deci sion. The most recent ecological and environmental fate risk asse ssment was completed June 1999 for the same purpose. Findings and conclusions from these risk assessments are summarized in the Registration Review: Preliminary Problem Form ulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Triphenyltin Hydroxide (TPTH) and TPTH (Triphenyltin Hydroxide) . Health Effects Division (HED) Scoping Document for Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an endangere d species assessment, for all uses of TPTH. For human health, EPA anticipates the need to conduct revised dietary an d occupational risk assessments during registration review. If toxico logical endpoints or po ints of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in the new assessments, as well as an y changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.8 Table 4: Anticipated Risk Assessments for TPTH’s 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 Y The Agency plans to eval uate risks to nontarget terrestrial and aquati c organisms, including Federally-listed threaten ed and/or endangered species.

Incidents Y For a discussion of TPTH’s reported ecological incidents, see page 14 of the Problem Formulation.

Human Health Dietary

Food Y The Agency anticipates conducting a revised dietary

risk assessment.

Drinking water Y The Agency plans to conduct a drinking water exposure assessment for TPTH.

Occupational

Handlers (mixers, loaders, applicators) Y The Agency anticipates conducting a revised 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, incidental oral, and

recreational N TPTH is not registered for us e in residential settings. Therefore, a residential exposure assessment is not required.

Other

Aggregate Y Evaluates the combined risk from dietary and residential exposures. Since there are no residential uses of TPTH, the aggregate risk estimate will be equivalent to the dietary risk estimate.

Cumulative N TPTH is not a member of a 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 of TPTH and that it specifies the residues to be measured for each commodity.

Incidents Y For a discussion of TPTH’s reported human incidents, see page 8 of the Scoping Document.9 Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Fate or toxicity data for the monophenyltin (MPT) degradate.

 Information (e.g., fate or toxicity data) rega rding inorganic forms of tin (Sn) once TPTH

is released in the environment.

 Information regarding whether MPT is more likely to form as an oxide or a hydroxide compound under certain circumstances.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).

TIMELINE

EPA has created the following estimated timelin e for the completion of TPTH’s registration
review in Table 5 below.

Table 5: Registration Review for TPTH – Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2012 - December Close Public Comment 2013 - February Case Development Final Work Plan 2013 - May

Issue DCI 2014 – Jan – March

Data Submission 2016 – Jan – March 30-day Public Comment Period for Draft Risk Assessments 2017 – July – Sept. Registration Review Decision 60-day Public Comment Period fo r Proposed Registration Review

Decision 2018 – Jan – March

Registration Review Decision and Begin Post-Decision Follow-up 2018 Total (years) 6

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration

review of TPTH.10 

### Appendix – Additional Areas Considered in TPTH’s Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

TPTH is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act 5 . In addition, no Total Maximum Daily Loads (TMDLs) have been developed for TPTH 6 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 7

. The Agency invites submission of water quality data for this pesticide. To the extent possible, data should c onform to the quality standards in Appendix

A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Re view Risk Assessment and Management Process 8 in order to ensure they can be us ed quantitatively or qua litatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to TPTH compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

7 http://www.epa.gov/owow/tmdl/

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm11 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for TPTH. The ecological risk asse ssment planned during registration review will allow the Agency to determine whether TPTH’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Se rvices), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network

North America filed a lawsuit in the United States District Court for the Northern District of California, against the Environmental Protecti on Agency (EPA) for allegedly failing to undergo

consultation with the United States Fish and W ildlife Service and the National Marine Fisheries Service regarding the eff ects of over 350 pesticides, including TPTH (listed as fentin hydroxide in the lawsuit), on over 200 endangered and th reatened species throughout the United States (Center for Biological Diversity, et al . v. EPA, et al., No. C 11-00293 (N.D.Cal.)

.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its reregistration decision for TPTH, EPA reviewed these data and selected the most sensitive endpoi nts for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), TPTH is subject to the endocrine screening part of the Endocrine Disruptor Screenin g Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 6712 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. TPTH is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for TPTH. For further information on the status of the EDSP, the policie s and procedures, the lis t of 67 chemicals, future lists, the test guidelines and the Tier 1 screeni ng battery, please visit our website 9

.

HUMAN STUDIES:

Occupational

Past TPTH risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pest icide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Databa se. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databa ses, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevai ling at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subj ects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on

these studies.

9 http://www.epa.gov/endo/