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Fluometuron Preliminary Work Plan – Table of Contents

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

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

STATUTORY AND REGULATORY AUTHORITY................................................................... 7

CHEMICAL FACTS ...................................................................................................................... 7

USE AND USAGE INFORMATION............................................................................................ 8

RECENT ACTIONS....................................................................................................................... 9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 9

TIMELINE.................................................................................................................................... 11

NEXT STEPS ............................................................................................................................... 11

Appendix – Additional Areas Considered in the Fluometuron Registration Review............... 12

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Registration Review –Preliminary Problem Formulation for Ecological Risk and 

Environmental Fate, Endangered Species, and Drinking Water Assessments for 

Fluometuron. Parker, Ronald; Hartless, Christine. March 15, 2016. 

2. Fluometuron. Human Health Assessment Scoping Document in Support of Registration 

Review. Van Alstine, Julie; Shelat, Shalu; McCarroll, Nancy. March 2, 2016. 

3. Fluometuron Tier I (Scoping) Review of Human Health Incidents and Epidemiology. 

Evans, Elizabeth; Recore, Shanna. March 3, 2016.

4. BEAD Chemical Profile (BCP) for Registration Review: Fluometuron (PC 035503). 

Ratnayake, Sunil; Alsadek, Jihad; Smearman, Stephen. March 4, 2016.

5. Fluometuron (035503) Screening Level Usage Analysis (SLUA). August 27, 2015.
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6. EFED Table 1 Report. May 28, 2015.

7. HED Master Label Report. May 28, 2015.

These and other supporting documents for the fluometuron registration review case may be 

found in the docket EPA-HQ-OPP-2015-0746 at http://www.regulations.gov.
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OVERVIEW

The docket for fluometuron is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0746). Fluometuron is a selective 

herbicide registered for the control of broadleaf weeds and grass weeds in cotton. In addition to 

the cotton use, there is one Section 24(c) special local needs label in North Carolina (EPA SLN No. 

NC-120002) for application to wildflowers for control of certain annual broadleaf weeds. 

Distribution and use of this product is restricted to North Carolina Department of Transportation

personnel only. There are no registered non-agricultural uses. This Preliminary Work Plan (PWP) 

document explains what EPA's Office of Pesticide Programs knows about fluometuron

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 fluometuron.

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 fluometuron and what types of new data or 

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

fluometuron. 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 fluometuron. 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 fluometuron. 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 fluometuron. For additional discussion of 

the anticipated data needs, see the Registration Review –Preliminary Problem Formulation for 

Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments 

for Fluometuron and Fluometuron. Human Health Assessment Scoping Document in Support of 

Registration Review. 

Table 1: Anticipated Data Needs for the Fluometuron Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Fluometuron

835.4100 Aerobic aquatic metabolism TGAI 24

850.2100 Avian acute oral toxicity test (passerine species) TGAI 12

850.3040 Field testing for pollinators2, 4 TEP 24

850.4100 Seedling emergence and seedling growth TEP 12

850.4150 Vegetative vigor TEP 12

850.6100 Environmental Chemistry and associated 

Independent Laboratory Validation, soil TGAI 12

850.6100

Environmental Chemistry Methods and 

associated Independent Laboratory Validation, 

water 

TGAI 12

860.1650 Submittal of Analytical Reference Standards 

(parent and metabolites) 

Parent and 

metabolites 24

Nonguideline 

(OECD 

213)

Honeybee adult acute oral toxicity2, 3 TGAI 12

Nonguideline 

(OECD 

237)

Honeybee larvae acute oral toxicity2, 3 TGAI 12

Nonguideline Honeybee adult chronic oral toxicity2, 3 TGAI 12

Nonguideline Honeybee larvae chronic oral toxicity2, 3 TGAI 12

 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 2 Additional guidance for the necessity and conduct of the bee studies is provided here: 

http://www2.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance 3 Tier 1 (Laboratory-based studies)
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Table 1: Anticipated Data Needs for the Fluometuron Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Nonguideline Residues in pollen and nectar/Field residue 

analysis2, 4 TEP 24

Nonguideline 

(OECD 

75)

Semi-field testing for pollinators (tunnel or 

colony feeding studies)2, 4 TGAI or TEP 24

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

 4 Tier 2 and 3 (Semi-field and full field colony-level studies). The need for a higher-tiered test for pollinators will be determined 

based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.
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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.

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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 fluometuron.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for fluometuron.

Table 2: Chemical Facts for Fluometuron

PC code 035503

Case Number 0049

CAS Number 2164-17-2

Year first registered 1974

Pesticide Type Herbicide

Chemical class Photosystem II Phenylurea herbicide 

Reregistration Eligibility 

Decision (RED)

September 2005

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable, tolerance reassessment was included in the RED. 

 5 http://www2.epa.gov/pesticide-reevaluation
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Table 2: Chemical Facts for Fluometuron

Cumulative group Not applicable. Fluometuron has not been identified as a member 

of a cumulative group that shares a common mechanism of 

toxicity.

40 CFR Citation Tolerances for fluometuron are established in §180.229

Dual-use Not applicable.

Non-pesticidal uses Not applicable. There are no identified non-pesticidal uses of 

fluometuron. 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Linsey Walsh, walsh.linsey@epa.gov, (703) 347-8030

Registration Division, 

Product Manager

Reuben Baris, baris.reuben@epa.gov, (703) 305-7356

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for fluometuron. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Fluometuron (PC 035503) in the registration 

review docket for more details.

Table 3: Fluometuron Use and Usage Information

Summary of Use Fluometuron is a selective herbicide registered for the control of 

broadleaf and grass weeds in cotton. 

Fluometuron can be tank mixed with other compatible herbicides 

to increase efficacy. 

Use Sites Cotton (section 3) and wildflowers (Section 24(c))

Summary of Usage From 2003-2013, fluometuron annual usage averaged 

approximately 551,000 pounds active ingredient (a.i.) on 

approximately 686,000 acres of cotton, for an average application 

rate of 0.80 lbs. a.i. per acre. The overall use of fluometuron 

decreased significantly after 1998, most likely due to the rapid 

adoption of glyphosate-tolerant cotton. There was a slight 

increase of fluometuron use observed around 2011 that may be 

due to the inclusion of fluometuron in herbicide resistance 

management programs. 

Formulation Type(s) Flowable liquid concentrate and emulsifiable concentrate. 

Application Method(s) Application methods include banded, broadcast, directed spray 

and simple spray, burn down treatment, and soil incorporation. 

Technical Registrant(s) ADAMA AGAN Ltd., Sharda Cropchem Limited 

No. of Registrations 6 Section 3 products6; 1 Section 24(c) product 

Restricted Use No

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

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

• In 2012, EPA required additional restrictions on fluometuron use near drinking water 

wells and on vulnerable soils (e.g., karst topographical features) and removed countyspecific prohibitions in Alabama and Georgia. Labels have recently been updated to 

reflect this change. 

• Registrants have requested the voluntary cancellation of the following products, which 

will be processed through the Federal Register:

o MANA Cotoran 4L (product registration #66222-32) 

o Flomet 4L (product registration #66330-260) 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for fluometuron was completed in 

2005 in preparation for the Reregistration Eligibility Decision. The most recent ecological and 

environmental fate risk assessment was completed in 2005 for the same purpose. Findings and 

conclusions from these risk assessments are summarized in the Registration Review –

Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered 

Species, and Drinking Water Assessments for Fluometuron and Fluometuron. 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

fluometuron. For human health, EPA anticipates 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 Preliminary Problem Formulation and HED Scoping Document.
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Table 4: Anticipated Risk Assessments for the Fluometuron 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 Will check for 

updates

For a discussion of reported ecological incidents for 

fluometuron, see page 15 of the Preliminary Problem 

Formulation.

Human Health

Dietary

Food Y EPA anticipates the need to conduct updated acute, 

chronic, and cancer dietary exposure and risk 

assessments. 

Drinking water Y

Occupational

Handlers (mixers, loaders, 

applicators)

Y EPA anticipates the need to conduct updated 

occupational handler dermal and inhalation 

assessments and a dermal post-application 

assessment.

Post-application Y

Residential

Handlers N There are no proposed or current registrations for 

products containing fluometuron that allow 

residential use. Therefore, residential handler and 

post-application exposure assessments will not be 

needed.

Post-application N

Other

Aggregate Y Evaluates the combined risk from dietary and 

residential exposures. As there are no residential uses, 

the revised aggregate assessment will be equivalent to 

the revised dietary assessment. 

Cumulative N Fluometuron has not been identified as a member of a 

cumulative group that shares a common mechanism 

of toxicity. 

Tolerances Y The tolerance expression in 40 CFR§180.229 will 

need to be updated so that it appropriately covers the 

metabolites and degradates of fluometuron and 

specifies the residues to be measured for each 

commodity.

Incidents Will check for 

updates

For a discussion of reported human incidents for 

fluometuron, see page 10 of the Scoping Document

and the Fluometuron Tier I (Scoping) Review of 

Human Health Incidents and Epidemiology.
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Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below.

• 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 fluometuron

registration review in Table 5 below.

Table 5: Projected Fluometuron Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2016 – March 

Close Public Comment 2016 – May

Case Development

Final Work Plan 2016 – August

Issue DCI 2016 – October – December

Data Submission 2018 – October – December

60-day Public Comment Period for Draft Risk 

Assessments7

2020 April – June

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2021 – January-March

Registration Review Decision and Begin Post-Decision 

Follow-up

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 fluometuron. 

 7 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 Fluometuron 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:

Fluometuron is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.

8

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for fluometuron.

9

 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.

10 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 Process11 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 fluometuron 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.

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

9

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES 10 http://www.epa.gov/owow/tmdl/ 11 http://www2.epa.gov/pesticide-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
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ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been 

conducted for fluometuron. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of fluometuron 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, subchronic 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 reregistration decision for fluometuron 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), fluometuron 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, 201312 and includes some 

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. 

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

chemicals.
14

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.13

HUMAN STUDIES:

Occupational

Past fluometuron 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) and the 

Agricultural Reentry Task Force (ARTF) 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.

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