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 Flucarbazone-sodium Registration Review. 12

References:

This Preliminary Work Plan summarizes 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. 06/05/13
3

7. HED Master Label Report. Flucarbazone-sodium. 06/05/13

These and other supporting documents for the flucarbazone-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 wheat, 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 review for flucarbazone-sodium.

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 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 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 flucarbazone-sodium. 

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 flucarbazone-sodium. 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.
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 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4100 Aerobic Soil Metabolism2 TGAI 24

Outstanding Data Requirements from Conditional Registration(s)3

835.4300 Aerobic Aquatic Metabolism TGAI -

850.1025 Acute Toxicity Estuarine and Marine Organisms –

Oyster

TGAI

-

850.1035 Acute Toxicity Estuarine and Marine Organisms –

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 2000 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 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.

4

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 flucarbazone-sodium.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for flucarbazone-sodium.

Table 2: Chemical Facts for Flucarbazone-sodium

PC code 114009

Case Number 7251

CAS Number 181274-17-9

Year first registered 2000

Pesticide Type Herbicide

Chemical class Sulfonylaminocarbonyltriazolinone

Reregistration Eligibility 

Decision (RED)

Because it was registered after November 1984, flucarbazonesodium was not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Because 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 Flucarbazone-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-sodium 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

Jolene 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: Flucarbazone-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 wheat, 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 wheat, including durum, winter wheat, grasses 

grown for seed, and conifers (plantations/nurseries)

Non-Agricultural: ornamental lawns and turf, including golf 

courses

Summary of Usage From 2008-2012, flucarbazone-sodium’s annual agricultural usage 

averaged 36,000 pounds of active ingredient (A. I.) treating an 

average of 2.4 million acres, for an average application rate of 

0.015 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) Water 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 LifeSciences
8

Table 3: Flucarbazone-sodium Use and Usage Information

No. of Registrations Seven Section 3 products5; Four Section 24c products

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.

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 information would include acres treated and application rates, timing and 

frequency of applications, and target pests of these uses.

Confirmation 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.

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

Median and 90th percentile reported use rates (lbs ai/A) from usage data – national, state, 

and county.

Typical application timing (date of first application and application intervals) – national, 

state, and county.

Usage/use information for non-agricultural uses.

Typical application interval (days).

State or local use restrictions.

Foreign 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 in tree nurseries, on residential turf, on golf courses, and 

on sod farms. The 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 Flucarbazone-Sodium. 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

flucarbazone-sodium. For human health, EPA anticipates the need to conduct revised dietary, 

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

 

5

Section 3 product labels can be obtained from the Pesticide Product 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 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.

Table 4: Anticipated Risk Assessments for the Flucarbazone-sodium 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 

Yes 

Incidents Will check for 

updates

There are multiple cases of terrestrial plant incidents 

for flucarbazone sodium, including a misuse of the 

product on corn, 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 revised 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 revised dietary risk assessment may be necessary 

to reflect the potential revised Estimated Drinking 

Water Concentrations (EDWCs).

Occupational

Handlers (mixers, loaders, 

applicators)

Yes A revised occupational exposure/risk assessment may 

be necessary to reflect updates to the Health Effects 

Divisions (HEDs) exposure policies, including 

updates to default exposure data and assumptions for 

body weights. An occupational exposure/risk 

assessment may

also need to be reassessed if changes to the toxicity 

endpoints or uncertainty factors are made during 

Registration Review.

Post-application Yes

Residential
10

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 flucarbazonesodium 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

TIMELINE

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

registration review in Table 5 below.

Table 5: Projected Flucarbazone-sodium Registration Review Timeline

Activities Estimated Date

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.
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Table 5: Projected Flucarbazone-sodium Registration Review Timeline

Activities Estimated Date

60-day Public Comment Period for Draft Risk 

Assessments6

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 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 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, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
12

Appendix – Additional Areas Considered in the Flucarbazone-sodium

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:

Flucarbazone-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, no Total Maximum Daily 

Loads (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 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 Process10 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_

group_name=PESTICIDES

9

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

10 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 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 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 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 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, 201311 and includes some 

 

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

chemicals.
14

pesticides scheduled for registration review and chemicals found in water. 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.12

HUMAN STUDIES:

Occupational and Residential

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 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.

 

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