2



### Flucarbazone

- sodium 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

................................ ................................ ................................ ............................... 11

Appendix

– Additional Areas Considered in the F lucarbazone

- sodium Registration Review

. 12

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. EFED Registration Review Problem Formulation for Flucarbazone Sodium

. E. Arnold, R.
Shamblen

. 10/31/13

2. Flucarbazone

- Sodium

. Human Health Assessment Scoping Document in Support of Registration Review . C. Smith, M. Perron, J. Van Alstine. 11/04/13

3. Flucarbazone

- sodium: Tier I Review of Human Incidents

. S. Recore, E. Evans

. 08/29/13

.

4. BEAD Chemical Profile for Registration Review: Flucarbazone

- sodium (114009)

. S. Ratnayake, R. Prieto, T. Wyatt

. 05/22/13

5. Flucarbazone

- sodium (114009) Screening Level Usage Analysis (SLUA)

. 05/07 /13

6. EFED Label Data Report

. Flucarbazone

- sodium

. 06/05/1 33

7. HED Master Label Report

. Flucarbazone

- sodium . 06/05/13

These and other supporting documents for the f lucarbazone

- sodium registration review case may be found in the docket EPA

- HQ

- OPP

- 2013

- 0283 at http://www.regulations.gov

.4

OVERVIEW

The docket for flucarbazone

- sodium is now open , initiating the first public comment period for
this registration review (docket number EPA

- HQ

- OPP

- 2013

- 0283 )

. Flucarbazone

- sodium is a systemic herbicide registered for use for the post

- emergence control of wild oat, green foxtail, and other grass and broadleaf weeds found in spring w heat , including durum, and winter wheat.
Flucarbazone

- sodium is also registered for use on grasses grown for seed, on conifers (plantations/nurseries), and on ornamental lawns and turf

. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about flucarbazone

- sodium

, 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 revi ew for flucarbazone

- sodium

.

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 flucarbazone

- sodium and what types of new data or other information would be helpful for the Agency to receive as it moves toward a
decision on flucarbazone

- sodium

. The Agency encourages all interested stakeholders to review
the PWP an d 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, residenti al, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for flucarbazone

- sodium

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the
docume nt provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for flucarbazone

- sodium

. 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 needs for flucarbazone

- sodium . For additional
discussion of the anticipated data needs, see the EFED Registration Review Problem Formulation for Flucarbazone Sodium and Flucarbazone

- Sodium

. Human Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the flucarbazone

- sodium Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism 2 T GAI 24

Outstanding Data Requirements from Condition al Registration (s) 3

835.4300 Aerobic Aquatic Metabolism TGAI

-

850.1025 Acute T oxicity E stuarine and M arine O rganisms

–

O yster TGAI

-

850.1035 Acute T oxicity E stuarine and M arine O rganisms

–

Mysid TGAI

-

850.1075 Estuarine/Marine Fish Acute Toxicity TGAI

- 850.2100 Avian Oral Acute Toxicity

– Passerine TGAI

- 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

2 Data are anticipated from studies that are conducted using two additional soils.

3 The studies listed in this section were previously required as a condition of registration in 200 0 and data have been
submitted and are in review. These studies will not be included in the anticipated Registration Review DCI because they are already required as a condition of registration

.6

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

. 4

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 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 F inal W ork P lan (FWP) and anticipated schedule for the registration review of flucarbazone

- sodium

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for flucarbazone

- sodium

.

Table 2: Chemical Facts for F lucarbazone

- sodium

PC code 114009

Case Number 7251

CAS Number 181274

- 17

- 9

Year first registered 2000 Pesticide Type Herbicide

Chemical class Sulfonylaminocarbonyltriazolinone

R eregistration Eligibility Decision (R E D) Because it was registered after November 1984, flucarbazone

sodium was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) B ecause this was registered as a new chemical subsequent to the passage of FQPA , flucarbazone

- sodium does not have a TRED.

4 http://www.epa.gov/oppsrrd1/registration_review/7 Table 2: Chemical Facts for F lucarbazone

- sodium

Cumulative group Not applicable. Flucarbazone

- sodium has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation Tolerances for flucarbazone

- sodium are established in 40 CFR Part
180.562

. Dual

- use Flucarbazone

- so dium is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses.

Non

- pesticidal uses There are no identified non

- pesticidal uses of flucarbazone

- sodium.

Pesticide Re

- evaluation Division, Chemical
Review Manager J olene Trujillo trujillo.jolene@epa.gov

703

- 347

- 0103 Registration Division, Product Manager Kable Davis davis.kable@epa.gov

703

- 306

- 0415

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for flucarbazone

- sodium

. Please see the BEAD Chemical Profile for Registration Review: Flucarbazone

- sodium (114009). in the registration review docket for more details

.

Table 3 : F lucarbazone

- sodium Use and Usage Information

Summary of Use Flucarbazone

- sodium is a systemic herbicide registered for use for the post

- emergence control of wild oat, green foxtail, and other grass and broadleaf weeds found in spring w heat , including durum,
and winter wheat. Flucarbazone

- sodium is also registered for use on grasses grown for seed, on conifers (plantations/nurseries), and on
ornamental lawns and turf.

Use Sites Agricultural: spring w heat , including durum, winter wheat

, gras ses grown for seed, and conifers (plantations/nurseries)

Non

- Agricultural: ornamental lawns and turf, including golf

courses Summary of Usage F rom 200 8

- 201 2 , flucarbazone

- sodium’s annual agricultural usage averaged 3 6 ,000 pounds of active ingredient (A. I.) treating an average of 2 .4 million acres, for an average application rate of

0.01 5 pounds A.I. per acre. Use in grass seed, conifer, and turf production is not included in this estimate as usage survey data do
not cover these sites. Formulation Type( s) W ater dispersible granules, emulsifiable concentrate, and soluble

concentrate. Application Method(s) This chemical is applied as broadcast and spot treatment. Product can be applied by ground or aerial spraying. Technical Registrant (s) Arysta LifeSciences8 Table 3 : F lucarbazone

- sodium Use and Usage Information

No. of Registrations Seven Section 3 products 5 ; Four Section 24c products

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below. The Agency would like to receive information about the role of flucarbazone

- sodium in the production of grass seed, conifers, and turf, and any benefits it may provide to users. Helpful informati on would include acres treated and application rates

, timing and frequency of applications , and target pests of these uses.

C onfirmation of the following label information : 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

. U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

. M edian and 90 th perc entile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

. Typical a pplication timing (date of first application and application intervals)

– national, state, and county

. Usage/use information for non

- agricultural uses

. Typical app lication interval (days)

. S tate or local use restrictions

. F oreign technical registrants not listed above who supply technical flucarbazone

- sodium
to the US market

.

RECENT ACTIONS

There are no recent actions for flucarbazone

- sodium.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for flucarbazone

- sodium was completed in 2009 for registration for use i n tree nurseries, on residential turf, on golf courses

, and

on sod f arms

. T he most recent ecological and environmental fate risk assessment was completed
2009 for the same purpose . Findings and conclusions from these risk assessments are
summarized in the EFED Registration Review Problem Formulation for Flucarbazone Sodium
and F lucarbazone

- Sodium

. Human Health Assessment Scoping Document in Support of Registration 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
flucarbazone

- sodium

. For human health, EPA anticipates the need to conduct revised dietary,
residential

, and occupational risk assessment s during registration review

. If toxicologic al

5 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website ( http://oaspub.epa.gov/pestlabl/ppls.home ).9

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 default exposure a ssumptions

.

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

EFED Problem Formulation and HED Scoping Document

.

Table 4: Anticipated Risk Assessments for the F lucarbazone

- sodium 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 Yes

Incidents Will check for updates There are multiple cases of terrestrial plant incidents

for flucarbazone sodium , i nclud ing a misuse of the product on c orn, for which there is no registered use.

For a full discussion of reported ecological incidents
for flucarbazone

- sodium

, see page 18 of the Problem
Formulation

. Human Health Dietary

Food Yes A r evised dietary risk assessment may be necessary to reflect the potential revised dietary exposure models, and/or toxicological points of departure ( PODs )

. Drinking water Yes A r evised dietary risk assessment may be necessary to reflect the potential revised Estimated Drinking Water Concentrations ( EDWCs )

. Occupational Handlers (m ixer s, loader s, applicators ) Yes A r evised occupational exposure/risk assessment may be necessary to reflect updates to the Health Effects Divisions ( H EDs) exposure policies, including

u pdates to default exposure data and assumptions for body weights. An o ccupa tional exposure/risk

assessment may also need to be reassessed if changes to the to xicity endpo ints or uncertainty factors are made during Registration Review.

Post

- application Yes

Residential10

Handlers Yes A revised residential exposure/risk assessment may be necessary to reflect updates to HED’s exposure policies, including updates to the Residential Standard Operating Procedures ( SOPs ) and assumptions for body weights. Residential exposure/risk assessments may also need to be reassessed if changes to the toxicity endpoints or uncertainty factors are made during Registration Review.

Post

- application Yes

Other Aggregate Yes The aggregate risk assessment for flucarbazone

sodium may need to be reassessed during Registration Review if dietary or residential exposure estimates are updated, or if changes to the toxicity endpoints or uncertainty factors are made during Registration
Review.

Cumulative No Flucarbazone

- sodium has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances No Tolerances will be revised as discussed on page 11 of
the HED Scoping Document.

Incidents Will check for updates For a discussion of reported human incidents for

flucarbazone

- sodium , see page 11 of the Scoping

Document and the Flucarbazone

- sodium: Tier I Review of Human Incidents

T IMELINE

EPA has created the following estimated timeline for the completion of the flucarbazone

- sodium registration review in Table 5 below

.

Table 5: Projected F lucarbazone

- sodium Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2013

– December

Close Public Comment 2014

– February
Case Development

Final Work Plan 2014

– May

Issue DCI 2014 July

– Sept.

Data Submission 2016 July

– Sept.11 Table 5: Projected F lucarbazone

- sodium Registration Review Timeline

Activities Estimated Dat e
6 0

- day Public Comment Period for Draft Risk

Assessments 6 2018 Jan.

- March

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2018 July

– Sept.

Registration Review Decision and Begin Post

- Decision
Follow

- up 2019

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 flucarbazone

- sodium

.

6 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, 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 F lucarbazone

- sodium 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 regi stration 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 (M RL 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 and MRLs in key export markets, providing as much specificity as possible regarding
the nature of the concern

.

Water Quality:

F lucarbazone

- sodium is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 7 In addition, n o Total Maximum Daily
Load s (TMDL) have been developed for flucarbazone

- sodium

. 8 More information on impaired
water bodies and TMDLs can be found at the Agency’s website

. 9 The Agency invites submission of water quality data for this pesticide. To the extent poss ible, 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 10 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 flucarbazone

- sodium 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.

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

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

gr oup_name=PESTICIDES

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

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm13

ENDANGERED SPECIES :

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

- sodium

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of flucarbazone

- sodium has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated crit ical 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), a s 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 toxici ty, 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 histopa thology, 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 flucarbazone

- sodium 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),

flucarbazone

- sodium 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 oc curring 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 re lationship 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 co ntains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 11 and includes some

11 Se e http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of
chemicals.14

pesticides scheduled for registration r eview and chemicals found in water

. For furt her information on the status of the EDSP, the policies and procedures, the list s of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 12

HUMAN STUDIES :

Occupationa l and Residentia l

Past flucarbazone

- sodium 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 pesti cides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database , and the Outdoor Residential Exposure Task Force (ORETF) Database

. EPA has reviewed all the s tudies 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 for 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

.

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