2 

### Kresoxim-methyl Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 4

Chemical Facts 5

Use and Usage Information 5

Recent Actions 6

Anticipated Risk Assessments for Registration Review 6

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in Kresoxim-methyl’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: Prelim inary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Dr inking Water Assessmen ts for Kresoximmethyl

. Elizabeth Riley, Iwona Maher. November 20, 2012.

2. Kresoxim-methyl. Human Health Assessment Scoping Document in Support of Registration Review . Myron S. Ottley, Meheret Negu ssie, Nancy Tsaur. November 30,

2012.

3. BEAD Chemical Profile for Registrati on Review: Kresoxim-methyl (129111). Carl Chen, Rafael Prieto, John Faulkner. June 5, 2012.

4. Kresoxim-methyl: Review of Human Incidents . Shanna Recore. October 9, 2012.

These and other supporting documents for the kresoxi m-methyl registration review case may be found in the docket EPA-HQ-OPP-2012-0861 at http://www.regulations.gov

.3 OVERVIEW

The docket for kresoxim-methyl is now open, initia ting the first public comment period for this registration review (docket number EPA-HQ-O PP-2012-0861). Kresoxim-methyl is a fungicide

in the strobilurin class that in hibits spore germination, sporulat ion, and mycelia growth on leaf surfaces. It is registered for use on pome fruits, cucurbits, grapes, pecans, commercial greenhouses, shade and lath-houses, outdoor nurseries and non-residential landscape areas. This Preliminary Work Plan (PWP) document explai ns what EPA's Office of Pesticide Programs knows about kresoxim-methyl, highlighting anticip ated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline fo r completing kresoxim-methyl’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 kresoxim-methyl and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on kresoxim-methyl. The Agency encourages all in terested stakeholders to review the PWP and Appendix and to provide comments and addition al information that will help the Agency’s decision-making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The PWP begins by listing the anticipated data n eeds for kresoxim-methyl. Next, it discusses the statutory and regulatory author ity for Registration Review. Then the document provides kresoxim-methyl’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 anticipated data needs for kresoxim-methyl. For additional discussion of the anticipat ed data needs, see the Registration Review: Preliminary Problem Formulation for Environmental Fate and Ec ological Risk, Endangered Species, and Drinking Water Assessments for Kresoxim-methyl and Kresoxim-methyl. Human Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for Kresoxim-methyl’s Registration Review

Guideline

Number Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

850.1350 Aquatic Invertebrate Chronic Life Cycle (saltwater) TGAI 12

850.1400 Fish Early-Life Stage (saltwater) TGAI 12 850.2100 Avian Acute Oral (p asserine species) TGAI 12 860.1340 Residue Analytical Method TGAI 24 870.7800 Immunotoxicity TGAI 12
TGAI = technical grade active ingredient

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 1

.

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

1 http://www.epa.gov/oppsrrd1/registration_review/5 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 kresoxim-methyl. Table 2 provides a summary of the current regulatory status of kresoxim-methyl.

Table 2: KRESOXIM-METHYL CHEMICAL FACTS

PC code 129111

Case Number 7026

CAS Number 143390-89-0 Year first registered 1998 Pesticide Type Fungicide

Chemical class Strobilurin Reregistration Eligibility Decision (RED) Kresoxim-methyl was register ed after November 1984, and therefore was not subject to reregistration.

Tolerance Reassessment Decision (TRED) Not applicable

Cumulative group Not applicable

40 CFR Citation Tolerances for kresoxim -methyl are established in 40 CFR 180.554. Dual-use Conventional pe sticidal uses only. Non-pesticidal uses No non-pestic idal uses of kresoxim-methyl.

Pesticide Re-evaluation Division, Chemical Review Manager Katie Weyrauch, weyrauch.katie@epa.gov , (703) 308-0166

Registration Division, Product Manager Mary Waller, waller.mary@epa.gov , (703) 308-9354

USE AND USAGE INFORMATION Table 3 summarizes the use and usage inform ation for kresoxim methyl. Please see the BEAD Chemical Profile for Registrati on Review: Kresoxim-methyl (129111) in the registration review

docket for more details.

Table 3: USE AND USAGE INFORMATION Summary of Use Kresoxim-methyl is a systemic fungicide in the strobilurin class. Kresoxim-methyl inhibits spor e germination, sporulation, and mycelia growth on the leaf surface , and is registered to control diseases such as apple scab and powdery mildew. Use Sites Registered for use on agricu ltural and non-agricultural use sites, including pome fruit, grapes, pecans, cucurbits, and ornamental plants in nurseries and greenhouses. Summary of Usage From 2006-2010, kresoxim-methyl’s annual agricultural usage averaged 30,000 pounds of active ingredient, treating an average of 250,000 acres. The average applic ation rate was 0.12 pounds active ingredient per acre. Formulation Type Water dispersible granules Application Methods Ground, aerial, manua lly pressurized handwand, and hose-end6 sprayer Technical Registrant BASF Corporation No. of Registrations 4 Section 3 product registrations; 2 technical and 2 end-use products 2

. Restricted Use No

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.

 Certain kresoxim-methyl labels are unclear with respect to application parameters like the size of the treated area, the extent of a trea ted “spot,” retreatment intervals, or maximum annual application rates. EPA expects to approximate these parameters in order to conduct a quantitative assessment for kresoxi m-methyl. The Agency will work with registrants to clarify kres oxim-methyl product labels.

 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.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites)

 Median and 90 th percentile reported use rates (lbs ai/acre) from usage data – national, state, and county

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

 Usage/use information for non-agricultural uses

 Typical application retreatment interval (days)

 State or local use restrictions

 Foreign technical registrants not listed above who supply te chnical kresoxim-methyl to

the US market

RECENT ACTIONS

A new use on cucurbits was register ed in 2006 (71 FR 50354; FRL-8088-1).

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for kresoxim-methyl was completed on July 26, 2006 to support the regist ration of kresoxim-methyl on cucurbits. The most recent ecological and environmental fate risk assessment was completed July 12, 2006 for the same purpose. Findings and conclusions from these risk assessments are summarized in the Registration Review: Problem Formulation for the Envi ronmental Fate, Ecological Risk, Endangered Species, and Drink Water Expos ure Assessment for Kresoxim-methyl and Kresoximmethyl: Human Health Assessment Scoping Docu ment in Support of Registration Review.

2 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website (http://oaspub.epa.gov/pestlabl/ppls.home).7 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 kresoximmethyl. For human health, EPA anticipates the n eed to conduct a revised dietary risk assessment during registration review as a ll future drinking water estimates will be based on separate assessments for kresoxim-methyl and its degradate, BF 490-1 in accordance with new Agency policy and guidance. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for regist ration review, they will be considered in the new assessments, as well as any changes to the sta ndard operating procedures or default exposure assumptions.

Table 4 summarizes the anticipated registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk A ssessments for Kresoxim-methyl’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 -

Incidents N No incidents were re ported in either the ecological incident information system (EIIS) or the avian monitory system (AIMS) databases. For additional discussion of kresoxim-methyl ’s reported ecological incidents, see page 14 of the Problem Formulation.

Human Health Dietary Food Y The need for a new dietary assessment will be dependent on whether drinking water estimates are revised. Furthermore, although a new version of DEEM (Version 3.16) has been released, a new dietary risk assessment may not be needed since it is anticipated that the change s in the model will not

affect the risk conclusion. Drinking water Y In accordance with Agency policy, kresoxim-methyl and its degradate, BF 490-1, will be assessed separately for future drinking water assessments. Therefore, if the estimated drinking water concentrations are revised, a new drinking water assessment may be conducted. Occupational8 Handlers (mixers, loaders, applicators) Y A new cancer handler risk assessment may be needed to include all of the regist ered crops, while accounting for changes in occupationa l assessment policy (i.e., unit exposures, body weights, and expected lifespan). Post-application Y A new cancer post- application risk assessment may

be needed to include all of the registered crops, while accounting for changes in occupational assessment policy (i.e., transfer coeffi cients, body weights, and expected lifespan).

Residential Handlers N There are no registered residential uses associated with kresoxim-methyl. Th erefore, a residential handler assessment is not required. Post-application Y A cancer reside ntial post-application exposure assessment was not previously performed. In accordance with the revised residential SOPs, a residential post-application risk assessment is needed to assess potential exposur e resulting from contact

with treated retail ornament als. Revised assessment will account for changes in SOPs (i.e., transfer coefficients, body weight and expected lifespan).

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. If there are changes to the dietary or residential estim ates, a revised aggregate assessment may be preformed. Cumulative N Kresoxim-methyl does not appear to produce a toxic metabolite produced by other substances. EPA has

not made a common mechanism of toxicity finding as to kresoxim-methyl and any other substance. Tolerances Y The data requirement for multi-residue methods is fulfilled; however, the methods are not suitable for

enforcement of tolerances. Incidents N Based on low frequency and severity of incident cases reported for kresoxim-methyl , there does not appear

to be a concern at this time that would warrant further investigation. The Agency will continue to monitor

the incident information a nd if a concern is raised, additional analysis will be included in a risk assessment. For a discussion of kresoxim-methyl reported human incidents, see page 10 of the Scoping

Document.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.9  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 time line for the completion of kresoxim-methyl’s registration review in Table 5 below.

Table 5: Registration Review for Kresoxim- methyl – 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 Open 30-day Public Comment Period for Dr aft Risk Assessments 2017 – July – Sept Registration Review Decision Open 60-day Public Comment Period for 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 kresoxim-methyl.10 

### Appendix – Additional Areas Considere d in Kresoxim-methyl’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:

Kresoxim-methyl is not identifie d as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 3 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for kresoxim-methyl 4 . More information on impaired

water bodies and TMDLs can be found at the Agency’s website 5

. The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in O PP’s Registration Review Risk Assessment and Management Process 6 in order to ensure they can be used quantitatively or qualitatively 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 kresoxim- methyl 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.

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

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

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

6 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 kresoxim-methyl. The ecological risk assessment planned during registration review will allow the Agency to determine wh ether kresoxim-methyl’s use has “no effect” or “may affect” federally listed threatened or endang ered species (listed species) or their designated

critical habitats. When an assessment conclude s that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildlife

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

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 most rece nt registration decisi on for kresoxim-methyl, EPA
reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), kresoxim-methyl is subject to th e endocrine screening part of th e Endocrine Disruptor Screening 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 67 chemicals, which contains 58 pesticide active in gredients and 9 inert ingredients. Kresoximmethyl is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of regi stration review, EPA will issue future EDSP orders/data call-ins, requiring the su bmission of EDSP screening assays for kresoxim-methyl.

For further information on the status of the ED SP, the policies and procedures, the list of 6712 chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our

website 7

.

HUMAN STUDIES:

Occupational

Past kresoxim-methyl 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, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pestic ide 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.

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