2

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 Environmental Protection Agency's current position 

based on the following documents: 

1. Problem Formulation for the Ecological Risk and Drinking Water 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 Scoping 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 Registration Review: Fluoxastrobin (028869). Leonard 

Yourman, Cynthia Doucoure, Derek Berwald. June 10, 2015.

5. Fluoxastrobin (028869) Screening Level Usage Analysis (SLUA). April 10, 2015.
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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 fluoxastrobin registration 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, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0295). Fluoxastrobin is a broadspectrum strobilurin fungicide that is used on crops such as corn, soybeans, wheat, peanuts, 

peppers, potatoes and non-agricultural uses such as turf and ornamentals. 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 timeline for completing the registration review for fluoxastrobin. 

 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about fluoxastrobin and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

fluoxastrobin. The Agency encourages all interested stakeholders 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 general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, 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 regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for fluoxastrobin. Finally, the 

Appendix to this document includes identification and discussion of some areas that are 

considered generally in Registration Review along with some additional chemical case-specific 

information. 

 
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ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs 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 Scoping Document in Support of Registration Review. 

Table 1: Anticipated Data Needs for the Fluoxastrobin Registration Review 

Guideline 

Number1 Study Title1 

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 ingredient; 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 
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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 States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. 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 of no unreasonable 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 program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.2

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

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. The regulations governing registration 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 docket 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 the 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 Strobilurins, 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-reevaluation
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Table 2: Chemical Facts for Fluoxastrobin

Cumulative group No cumulative risk assessment is required at this time since the 

Agency has not made a determination regarding a common mode 

of action 

40 CFR Citation Tolerances for fluoxastrobin are established in 40 CFR §180.609. 

Dual-use With chlorothalonil, myclobutanil, 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 information for fluoxastrobin. Please see the BEAD 

Chemical Profile for Registration Review: Fluoxastrobin in the registration review docket for 

more details. 

Table 3: Fluoxastrobin Use and Usage Information

Summary of Use Broad-spectrum fungicide registered as a quinone outside 

inhibitor (QoI). Like other strobilurin fungicides, fluoxastrobin is 

site specific and it provides significant control of plant disease 

caused by a wide range of pathogens. 

Use Sites Agricultural use sites registered for crop subgroups 13-07G low 

growing berries, 1C tuberous and corm vegetables, 4B leaf 

petioles, 9A melons, and 9B squash/cucumber, as well as corn, 

fruiting vegetables, peanuts, potatoes, rice, sorghum, soybeans, 

and wheat. Fluoxastrobin is also used on sod farm turf. 

For non-agricultural use sites, fluoxastrobin is registered for use 

on ornamentals and ornamental lawns and turf.

Summary of Usage The top uses in terms of average percent crop treated (PCT) and 

average pounds a.i. applied annually 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 low, while the pounds a.i. applied 

on wheat (10,000) is considerably higher. 

Formulation Type(s) Dry flowable, emulsifiable, flowable, and soluble concentrates, as 

well as granules. 

Application Method(s) Products can be applied as broadcast, banded, chemigation, in 

furrow, or soil drench treatments using either aerial, ground, 

sprinkler irrigation, or granule applicator equipment. 

Technical Registrants Bayer Cropscience LP; Arysta Lifescience North America, LLC 
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Table 3: Fluoxastrobin Use and Usage Information

No. of Registrations 2 Technical registrations, 9 Section 3 products3 and 2 SLNs 

Restricted Use No 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below. 

 For some terrestrial uses, the number of applications of fluoxastrobin that can be applied 

per calendar year or the maximum annual application rate for a given use is not explicitly 

stated on many of the current labels. 

 Verify the accuracy of the label information that EPA is providing, including sites of 

application; formulations; application methods and equipment; maximum application 

rates; frequency of application, 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 technical fluoxastrobin to the 

US market. 

RECENT ACTIONS 

There are no recent actions for fluoxastrobin. 

ANTICIPATED RISK ASSESSMENTS 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 Ecological 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 anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of 

fluoxastrobin. For human health, EPA does not anticipate the need to conduct revised dietary, 

residential, and occupational risk assessments during registration review. If toxicological 

endpoints or points 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 any changes to 

the standard operating procedures or default exposure assumptions. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 

 

3

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
9

Table 4: Anticipated Risk Assessments 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 reported 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 assessment is not anticipated to be 

Post-application N needed. 

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 fluoxastrobin 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 fluoxastrobin, there does not appear 

to be a concern at this time that would warrant further 

investigation. For a discussion 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. 
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 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

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

TIMELINE 

EPA has created the following estimated timeline 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 

Assessments4

January – March 2020 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

October – December 2020 

Registration Review Decision 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 issue 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. 
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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 submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, 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, providing 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 Total 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 Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process8 in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, 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 their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to fluoxastrobin 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.htm
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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 effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated critical 

habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

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

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, sub-chronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for fluoxastrobin EPA 

reviewed these data and selected 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 screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether 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 other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the 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 estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects 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 ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 20139

 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 known or likely endocrine disruptors. 

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, 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 pesticide 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), the 

Agricultural Reentry Task Force (ARTF) Database, 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 clear 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 was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier 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 well as any other research involving 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 applicable regulatory requirements are met, including, but not limited to, 

the requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects. 

 

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