2 

### Fluometuron Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 4

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 5

STATU TORY AND REGULATORY AUTHORITY

................................ ................................ ... 7

CHEMICAL FACTS

................................ ................................ ................................ ...................... 7

USE AND USAGE INFORMATION

................................ ................................ ............................ 8

RECENT ACTIONS

................................ ................................ ................................ ....................... 9

ANTICIPATED R ISK 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 summarize s 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 Healt h Assessment Scoping Document in Support of Registration

Review. Va n 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

.3 6. EFED Table 1 Report

. May 28, 2015

.

7. HED Master Label Report. May 28, 2015

.

These and other supporting documents for the fluome t uron registration review case may be

found in the docket EPA

- HQ

- OPP

- 2015

- 0746 at http://www.regulations.gov

.4 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 c ontrol of certain annual broadleaf weeds

. Distribution and u se 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 w hat 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

tim eline 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, b y 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; agri cultural 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 an d regulatory authority for R egistration R eview. 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 R egistration R eview along with some additional chemical case

- specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data nee ds 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 Fl uometuron. Human Health Assessment Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the Fluometuron Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata 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 pollinators 2 , 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

Non

guideline (OECD

213 ) Honeybee adult a cute oral toxici ty 2

, 3 TGAI 12

Non

guideline (OECD

237 ) Honeybee larvae a cute oral toxicity 2

, 3 TGAI 12

No n

g uideline Honeybee adult c hronic oral toxicity 2

, 3 T GAI 12

No n

g uideline Honeybee larvae c hronic oral toxicity 2

, 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

- guida nce

3 Tier 1 (Laboratory

- based studies)6 Table 1: Anticipated Data Needs for the Fluometuron Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

No n

g uideline R esidues in pollen and nectar /Field residue analysis 2

, 4 TEP 24

Non

guideline (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

- tier ed test for pollinators will be determined based upon lower

- tiered tests and/or other lines of data and the need for a refine d pollinator risk assessment.7 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 envi ronment 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 5

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicid e, 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

. T he 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 additi onal 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 F inal W ork P lan (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

R eregistration Eligibility Decision (R E D) September 2005

Tolerance Reassessment Eligibility Decision (TRED) Not applicable, tolerance reassessment was included in the RED.

5 http://www2.epa.gov/pesticide

- reevaluation8 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 no n

- 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 s elective 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 s light

increase of f l uometuron use observed around 2011 that may be

due to the inclusion of fluo meturon 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 si mple spray, burn down treatment, and soil incorporation. Technical Registrant (s) ADAMA AGAN Ltd. , Sharda Cropchem Limited No. of Registrations 6 Section 3 products 6 ; 1 Section 24 ( c ) product

Restricted Use No

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

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

specific prohibitions in Alabama and Georgia. Labels have recently been updated to

r eflect this change.

• Registrants have reque sted 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

. T he 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 Regist ration Review.

During registration review, t he 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 assessment s 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 assessment s
, as well as any changes to the standard operating p rocedures or defa ult exposure assumptions

.

T able 4 below summarizes the anticipated registration review risk assessments based on the

EFED Preliminary Problem Formulation and HED Scoping Document

.10 Table 4: Anticipated Risk Assessments for the Fluometuron Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical 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

fluome t uron, 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

assessment s. 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 E valuates 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 degradat es 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

.11 Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , 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 e stimated timeline for the completion of the fluometuron registration review in Table 5 below

.

Table 5: Projected Fluometuron Registration Review Timeline

Activities Estimated Dat e 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

6 0

- day Public Comment Period for Draft Risk

Assessments 7 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 6 0

- 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 Registrat ion 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.12 Appendix

– Additional Areas Considered in the Fluome t uron Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould 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 (MRL s ) 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 a nd MRLs in key export markets, providing as much specificity as possible regarding

the nature of the concern.

Water Quality:

Flu ometuron is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Cle an Water Act

. 8 In addition, n o Total Maximum Daily Load s (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 Process 11 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, regardl ess 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 seg ments 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/pest icide

- reevaluation/opp

- guidance

- submission

- state

- and

- tribal

- water

- quality

- monitoring

data13 ENDANGERED SPECIES :

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

conducted for fluometuron

. The ecological risk assessment planned d uring 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, sexu al 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 g roups. 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), fluome turon 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 wi ldlife 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 ba ttery 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 wi th 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 ca used 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, 2013 12 and includes some pesticides scheduled for regi stration 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

- 047 7

- 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 lis ts, 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 gen eric pesticide exposure databases such as the Pesticide Ha ndlers 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. A ll applicable requirements of EPA’s Rule f or the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued reliance on

these studies

.

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

- disruption