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### Fluoxastrobin Preliminary Work Plan – Table of Contents

OVERVIEW ...................................................................................................................... ............. 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY ................................................................... 6

CHEMICAL FACTS ................................................................................................................ ...... 6

USE AND USAGE INFORMATION ............................................................................................ 7

RECENT ACTIONS ................................................................................................................ ....... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE ...................................................................................................................... .............. 10

NEXT STEPS .................................................................................................................... ........... 10

Appendix – Additional Areas Considered in the Fluoxastrobin Registration Review ............. 11

References:

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

1. Problem Formulation for the Ec ological Risk and Drinking Wa ter Exposure Assessments to be conducted for the Registration Review of Fluoxastrobin. Rochelle F. H. Bohaty, Ph.D., December 2, 2015.

2. Fluoxastrobin. Human Health Assessment Sc oping Document in Support of Registration

Review . Minerva Mercado, Donald Wilbur , Meheret Negussie. December 9, 2015.

3. Fluoxastrobin: Tier I (Scoping) Review of Human Incidents and Epidemiology. Elizabeth Evans, Shanna Recore. November 10, 2015.

4. BEAD Chemical Profile for Regist ration Review: Fluoxastrobin (028869). Leonard Yourman, Cynthia Doucoure, Derek Berwald. June 10, 2015.

5. Fluoxastrobin (028869) Screening Level Usage Analysis (SLUA). April 10, 2015.3 6. Fluoxastrobin (028869) EFED Table 1 Report. March 3, 2015

7. Fluoxastrobin (028869) HED Master Label Report. March 3, 2015.

These and other supporting documents for the fl uoxastrobin registrati on review case may be found in the docket EPA-HQ-OPP-2015-0295 at http://www.regulations.gov

.4 OVERVIEW

The docket for fluoxastrobin is now open, initiati ng the first public comment period for this registration review (docket number EPA- HQ-OPP-2015-0295). Fluoxast robin is a broadspectrum strobilurin fungicide that is used on crops such as corn, soybeans, wheat, peanuts, peppers, potatoes and non-agricultur al uses such as turf and orna mentals. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about fluoxastrobin, highlighting anticipated 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 timelin e for completing the registration review for fluoxastrobin.

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 fluoxastrobin 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 fluoxastrobin. The Agency encourages all inte rested 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 Preliminary Work Plan begins by listing the anticipated data needs for fluoxastrobin. Next, it discusses the statutory and re gulatory authority for Registrati on Review. Then the document provides chemical facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration revi ew timeline for fluoxastrobin. Finally, the Appendix to this document includes identifica tion and discussion of some areas that are considered generally in Registra tion Review along with some a dditional chemical case-specific

information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data need s for fluoxastrobin. For additional discussion of the anticipated data needs, see the Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments to be conducted for the Registration Review of Fluoxastrobin and Fluoxastrobin. Human Health Assessment Scopi ng Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Fluoxastrobin Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Fluoxastrobin

850.6100 Analytical Method in Water (Independent lab validation) TGAI 12

850.1770 Whole Sediment: Chronic Invertebrates

Freshwater TGAI 12

850.1760 Whole Sediment: Chronic Invertebrates Marine TGAI 12

Nonguideline Honey Bee Larvae Acute Oral Toxicity TGAI 12

Nonguideline Honey Bee Larvae Chronic Oral Toxicity TGAI 12

Nonguideline Honey Bee Adult Chronic Oral Toxicity TGAI 12

Nonguideline Semi-Field Testing For Pollinators TEP 24

Nonguideline Field Trial of Residues in Pollen and Nectar TEP 24

850.3040 Field Testing for Pollinators TEP 24
TGAI = technical grade active ingredie nt; TEP = typical end-use product;

1 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-2009-0154-00286 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. 2

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 fluoxastrobin.

CHEMICAL FACTS

Table 2 provides a summary of th e chemical facts for fluoxastrobin.

Table 2: Chemical Facts for Fluoxastrobin

PC code 028869

Case Number 7044

CAS Number 361377-29-9 Year first registered 2005 Pesticide Type Fungicide

Chemical class Strobilu rins, methoxyacrylates Reregistration Eligibility Decision (RED) NA

Tolerance Reassessment Eligibility Decision (TRED) Not applicable as a RED was never completed.

2 http://www2.epa.gov/pesticide-reevaluation7 Table 2: Chemical Facts for Fluoxastrobin

Cumulative group No cumulative risk assessme nt is required at this time since the Agency has not made a determin ation regarding a common mode

of action

40 CFR Citation Tolerances for fluoxastr obin are established in 40 CFR §180.609. Dual-use With chlorothalonil, mycl obutanil, tebuconazole, or flutriafol Non-pesticidal uses No non-pesticidal uses.

Pesticide Re-evaluation Division, Chemical Review Manager Bilin Basu, basu.bilin@epa.gov (703) 347-0455

Registration Division, Product Manager Hope Johnson, johnson.hope@epa.gov (703) 305-5410

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage info rmation for fluoxastrobin. Please see the BEAD Chemical Profile for Regist ration Review: Fluoxastrobin in the registration review docket for

more details.

Table 3: Fluoxastrobin Use and Usage Information

Summary of Use Broad-spectrum fungici de registered as a quinone outside inhibitor (QoI). Like other strobi lurin fungicides, fluoxastrobin is site specific and it provides signi ficant control of plant disease caused by a wide range of pathogens. Use Sites Agricultural use sites regi stered for crop subgroups 13-07G low growing berries, 1C tuberous and corm vegetables, 4B leaf petioles, 9A melons, and 9B squa sh/cucumber, as well as corn, fruiting vegetables, peanuts, potat oes, rice, sorghum, soybeans,

and wheat. Fluoxastrobin is al so used on sod farm turf.

For non-agricultural use sites, fluox astrobin is registered for use

on ornamentals and ornamental lawns and turf. Summary of Usage The top uses in terms of average percent cr op treated (PCT) and average pounds a.i. applied a nnually include the following: peanuts, peppers, and wheat, each with an average PCT of <2.5%. The average annual pounds a.i. applied on peppers (1,000) and peanuts (2,000) are relatively lo w, while the pounds a.i. applied on wheat (10,000) is considerably higher. Formulation Type(s) Dry flowable, emulsifiab le, flowable, and soluble concentrates, as well as granules. Application Method(s) Products can be appl ied as broadcast, banded, chemigation, in furrow, or soil drench treatments using either aerial, ground, sprinkler irrigation, or gra nule applicator equipment. Technical Registrants Bayer Cropscience LP; Arysta Lifescience North America, LLC8 Table 3: Fluoxastrobin Use and Usage Information

No. of Registrations 2 Technical registrations, 9 Section 3 products 3 and 2 SLNs

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.

 For some terrestrial uses, the number of appli cations of fluoxastrobin that can be applied per calendar year or the maximum annual applica tion rate for a given use is not explicitly stated on many of the current labels.

 Verify the accuracy of the label informati on that EPA is providi ng, including sites of application; formulations; application me thods and equipment; maximum application rates; frequency of appli cation, application intervals, and maximum number of applications per season; and geographic limitations on use.

 Usage information for non-agricultural uses.

 Foreign technical registrants not listed above who supply te chnical fluoxastrobin to the

US market.

RECENT ACTIONS

There are no recent actions for fluoxastrobin.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for fluoxastrobin was completed March 27, 2013 for new proposed uses on melon subgroup 9A and sorghum, along with establishment of permanent tolerances on meat and amendments to milk and milk fat tolerances. The most recent ecological risk assessment was completed March 19, 2013 to for use on melon and sorghum. Findings and conclusions from these risk assessments are summarized in the Problem Formulation for the Ecol ogical Risk and Drinking Water Exposure Assessments to be Conducted for the Registration Review of Fluoxastrobin and Fluoxastrobin. Human Health Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an enda ngered species assessment, for all uses of fluoxastrobin. For human health, EPA does not an ticipate the need to conduct revised dietary, residential, and occupational risk assessments during registration review . If toxicological endpoints or points of departure ar e 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 any 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.

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

(http://oaspub.epa.gov/pestlabl/ppls.home).9 Table 4: Anticipated Risk A ssessments for the fluoxastrobin 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 will conduct a comprehensive ecological assessment, including an endangered species

assessment.

Incidents Will check for updates For a discussion of reporte d ecological incidents for fluoxastrobin, see page 29 of the Problem

Formulation.

Human Health Dietary

Food N A drinking water assessment and potentially a dietary exposure assessment may be needed if additional data

on non-extracted residues in laboratory fate studies are not provided. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) N An occupational risk assessment is not anticipated to

be needed. Post-application N

Residential

Handlers N A residential risk asse ssment is not anticipated to be

needed. Post-application N

Other Aggregate Y An aggregate risk assessment may be needed if

additional data on non-extracted residues in laboratory fate studies are not provided. Cumulative N There does not appear to be a common mechanism of toxicity between fluoxastr obin and other substances. Tolerances N The Agency will not need to revisit the tolerances during registration review.

Incidents Will continue

to check for updates Based on the low frequency and severity of incident cases reported for fluoxastro bin, there does not appear

to be a concern at this time that would warrant further investigation. For a disc ussion of reported human incidents for fluoxastrobin, see page 2 of the Scoping

Document and the Fluoxastrobin: Tier I (Scoping) Review of Human Incidents and Epidemiology

.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.10  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 the fluoxastrobin registration review in Table 5 below.

Table 5: Projected Fluoxastrobin Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period December 2015 Close Public Comment February 2016 Case Development Final Work Plan April – June 2016 Issue DCI July – September 2016 Data Submission July – September 2018 60-day Public Comment Period for Draft Risk

Assessments 4 January – March 2020

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision October – December 2020

Registration Review Decisi on and Begin Post-Decision Follow-up April – June 2021

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 fluoxastrobin.

4 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.11 

### Appendix – Additional Areas Considered in the Fluoxastrobin 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:

Fluoxastrobin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 5 In addition, no Tota l Maximum Daily Loads (TMDL) have been developed for fluoxastrobin. 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 conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 8 in order to ensure they can be us ed 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 fluoxast robin 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.htm12 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for fluoxastrobin. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of fluoxastrobin has “no e ffect” or “may affect” federally listed threatened or endangered specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’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.

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. Collectivel y, these studies include acute, sub-chronic 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 recent registration decision for fluoxastrobin 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), fluoxastrobin is subject to the endocrine screen ing part of the 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 pest icide active ingredient s and 9 inert ingredients. A second list

of chemicals identified for EDSP sc reening was published on June 14, 2013 9 and includes some

9 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.13 pesticides scheduled for registration review and chemicals found in water

. Neither of these lists

should be construed as a list of know n or likely endocri ne disruptors.

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

website. 10

HUMAN STUDIES:

Occupational and Residential

Past fluoxastrobin 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 Pest icide Handlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Databa se, and the Outdoor Residential Exposure Task Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no cl ear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies

Chemical-specific Human Studies

Past fluoxastrobin risk assessments have relied in part on several human studies which may have involved intentional exposure to fluoxastrobin. In the course of registration review EPA will reconsider these studies, as we ll as any other research involvi ng intentional exposure of human subjects to fluoxastrobin brought to its attention. If EPA decides to rely on any of these studies, EPA will ensure that all applic able regulatory requirements are met, including, but not limited to, the requirements for EPA ethics review and Hu man Studies Review Boar d review of certain research involving intentional exposure of human subjects.

10 http://www2.epa.gov/endocrine-disruption