2

Sulfometuron Methyl Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 4

Sulfometuron Methyl Facts 5

Use and Usage Information 5

Recent Actions 6

Anticipated Risk Assessments for Registration Review 7

Timeline 9

Next Steps 9

Appendix - Additional Areas Considered in Sulfometuron Methyl’s Registration Review

10

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 Environmental Fate, 

Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments for Sulfometuron Methyl. Barrett, Sternberg. December 10, 2012.

2. Sulfometuron Methyl: Human Health Assessment Scoping Document in Support of 

Registration Review. Britton, Liccione, Savoia. November 8, 2012

3. BEAD Sulfometuron Methyl Chemical Profile. Alsadek, Ratnayake, Smearman. August 1, 

2012.

4. Sulfometuron Methyl: Review of Human Incidents. Recore. August 1, 2012.

5. Sulfometuron Methyl: PRD Label Data Report Food/Feed & Non-Food/Non-Feed Uses 

Considered in Registration Review Work Planning.

These and other supporting documents for the Sulfometuron Methyl registration review case may 

be found in docket EPA-HQ-OPP-2012-0433 at http://www.regulations.gov.
3

OVERVIEW

The docket for sulfometuron methyl is now open, initiating the first public comment period for

this registration review (docket number EPA-HQ-OPP-2012-0433). Sulfometuron methyl is a 

sulfonylurea herbicide. It is a non-food/non-feed use chemical currently registered for 

commercial pre- and post-emergent applications to manage annual and perennial broadleaf 

weeds and grasses in non-agricultural sites (i.e., forestry, rights of way, non-crop industrial sites, 

and unimproved turf). This Preliminary Work Plan (PWP) document explains what EPA's 

Office of Pesticide Programs knows about sulfometuron methyl, 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 

sulfometuron methyl’s review.

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 sulfometuron methyl and what types of new 

data or other information would be helpful for the Agency to receive as it moves toward a 

decision on sulfometuron methyl. 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 sulfometuron methyl. 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 sulfometuron methyl. 

Next, it discusses the statutory and regulatory authority for Registration Review. Then the 

document provides sulfometuron methyl’s facts, use and usage information, recent actions, the 

anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix 

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

generally in Registration Review along with some additional sulfometuron methyl case-specific 

information.
4

ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for sulfometuron methyl. For additional 

discussion of the anticipated data needs, see the Registration Review: Preliminary Problem 

Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health 

Drinking Water Exposure Assessments for Sulfometuron Methyl and Sulfometuron Methyl: 

Human Health Assessment Scoping Document in Support of Registration Review.

Anticipated Data Needs for Sulfometuron Methyl’s Registration Review

Guideline 

Number Study Title Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.6100

Environmental Chemistry Methods and Associated 

Independent Laboratory Validation for soil and 

water1

TGAI 24

835.4100 Aerobic soil metabolism TGAI & TEP 24

870.7800 Immunotoxicity Study TGAI 12

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

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 website2

.

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 

 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

http://www.epa.gov/oppsrrd1/registration_review/
5

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 sulfometuron methyl.

SULFOMETURON METHYL FACTS

PC code 122001

Case Number 3136 

CAS Number 74222-97-2

Year first registered 1982

Pesticide Type Herbicide

Sulfometuron Methyl

class

Sulfonylurea

Reregistration Eligibility 

Decision (RED)

2008 (Amended in December 2009 and April 2011)

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not Applicable

Cumulative group Not Applicable

40 CFR Citation Not Applicable – No Tolerances

Dual-use Not Applicable

Non-pesticidal uses Sugar cane ripener in Brazil

Pesticide Re-evaluation 

Division, Sulfometuron 

Methyl Review Manager

Rusty Wasem, wasem.russell@epa.gov, 703-305-6979

Registration Division, 

Product Manager

Bo Davis, davis.kable@epa.gov, 703-306-0415

USE AND USAGE INFORMATION

Please see the BEAD Sulfometuron Methyl Chemical Profile in the registration review docket for 

more details.

Summary of Use Sulfometuron methyl is a sulfonylurea herbicide. It is a nonfood/non-feed use chemical currently registered for commercial 

pre- and post-emergent applications to manage annual and 

perennial broadleaf weeds and grasses.

Use Sites Non-crop areas, airports, asphalt paving, bare ground, barrier strips, 

fence rows, farm yards, industrial sites, lumber yards, railroads, 

right-of-way, roadsides, sewage disposal areas, swamps, storage 

tank farms, forest trees, ornamental lawns and turf, drainage 

systems, drained canals, uncultivated areas, loading docks 

(outdoor), and storage areas (outdoor)

Summary of Usage The Agency has limited usage information on non-agricultural sites. 

Available data from 2006 show use of sulfometuron methyl by 
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lawn care operators totaling an estimated 38,000 lbs. a.i.

(Kline and Company, Inc., 2006). Sulfometuron methyl was

considered one of the top ten herbicides for forestry and timberland 

between 2001 and 2006. EPA also found that sulfometuron methyl 

was applied to over 1.5 million non-agricultural acres in the late 

1990's.

Formulation Types Sulfometuron methyl is formulated as a water dispersible granular 

and soluble concentrate. 

Application Methods Sulfometuron methyl is applied using ground or aerial application 

methods.

Technical Registrants Celsius Property B.V., E.I. DuPont de Nemours and Company, 

NuFarm Limited

No. of Registrations Approximately 19 FIFRA Section 3 registrations3 and no FIFRA 

Section 24(c) registrations

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.

• 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/1000 sq ft) from usage data –

national, state, and county

• 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 or domestic technical registrants not listed above who supply technical 

sulfometuron methyl to the US market

RECENT ACTIONS

The revised RED for sulfometuron methyl was completed in December 2009. The sulfometuron 

methyl RED mitigation was further modified in April 2011. These documents as well as the 

assessments supporting the sulfometuron methyl RED may be found in docket EPA-HQ-OPP2008-0194 at www.regulations.gov. 

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

(http://oaspub.epa.gov/pestlabl/ppls.home).
7

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for sulfometuron methyl was 

completed in August 2008 to support the RED. The most recent ecological and environmental 

fate risk assessments were completed in July 2008 to support the RED and in February 2009 to 

support a new use on rangeland. Findings and conclusions from these risk assessments are 

summarized in the Registration Review: Preliminary Problem Formulation for Environmental 

Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments for Sulfometuron Methyl and Sulfometuron Methyl: 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

sulfometuron methyl. Under the current use patterns, EPA does not anticipate the need to revise

the residential and occupational risk assessments during registration review. Likewise, under the 

current registered use patterns, EPA does not anticipate the need to revise the dietary (drinking 

water only) risk assessment. However, a revised human health risk assessment may be required 

if changes that warrant such a revision occur such as new use patterns, toxicological endpoints 

or points of departure change based on the data that are anticipated to be required for registration 

review, or any changes to the standard operating procedures or default exposure assumptions.

The table below summarizes the anticipated registration review risk assessments.

Anticipated Risk Assessments for Sulfometuron Methyl’s 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 Risk assessment will be conducted on parent 

sulfometuron methyl. 

Incidents Yes For a discussion of sulfometuron methyl’s reported 

ecological incidents, see page 28 of the Problem 

Formulation.

Human Health

Dietary

Food No No food uses

Drinking water No Will be updated if estimated concentrations are 

updated in new drinking water assessment or if there 

are any revisions to the toxicological endpoints.

Occupational
8

Handlers (mixers, loaders, 

applicators)

No Based upon current use patterns, a new occupational 

handler assessment is not needed at this time. If 

occupational exposure estimates or toxicological 

endpoints change, the occupational handler 

assessment will be updated.

Post-application No Based upon current use patterns, a new occupational 

post-application assessment is not needed at this time. 

If occupational exposure estimates or toxicological 

endpoints change, the occupational handler 

assessment will be updated.

Residential

Handlers No Not registered for residential use.

Post-application No Not registered for residential use.

Other

Aggregate No Evaluates the combined risk from dietary and 

residential exposures. There are no registered 

residential uses. 

Cumulative No Sulfometuron methyl has not been identified as a 

member of a common mechanism group for 

cumulative risk assessment.

Tolerances No There are no registered food uses, and therefore no 

tolerances. 

Incidents For a discussion of sulfometuron methyl’s reported 

human incidents, see Sulfometuron Methyl: Review of 

Human Incidents in docket EPA-HQ-OPP-2012-0433 

at http://www.regulations.gov

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).

Additional use information requested for this registration review, and of particular interest to 

EPA, is described below.

• Information about the use of sulfometuron methyl on non-agricultural sites such as: 

ornamental forest trees, loading docks (outdoor), and storage areas (outdoor).
9

TIMELINE

EPA has created the following estimated timeline for the completion of sulfometuron methyl’s

registration review.

Registration Review for Sulfometuron Methyl – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2012 – Dec.

Close Public Comment 2013 – Feb.

Case Development

Final Work Plan 2013 - Mar.-Jun.

Issue DCI 2014 - Jan. - Mar.

Data Submission 2016 - Jan. - Mar.

Open 30-day Public Comment Period for Draft Risk Assessments 2017 - Jul. - Sep.

Registration Review Decision

Open 60-day Public Comment Period for Proposed Registration Review 

Decision

2018 - Jan. - Mar.

Registration Review Decision and Begin Post-Decision Follow-up 2018

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 sulfometuron methyl.
10

Appendix – Additional Areas Considered in Sulfometuron Methyl’s

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. Because sulfometuron methyl is not registered for food/feed uses in 

the U.S., it has no U.S. tolerances; therefore, the Agency does not anticipate any trade irritant 

issues for it.

Water Quality:

Sulfometuron methyl is not identified as a cause of impairment for any water bodies listed as 

impaired under section 303(d) of the Clean Water Act4

. In addition, no Total Maximum Daily 

Loads (TMDL) have been developed for sulfometuron methyl5. More information on impaired 

water bodies and TMDLs can be found at the Agency’s website6

. 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 Process7 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 sulfometuron methyl compared to the general population.

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

5

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

group_name=PESTICIDES

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

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
11

Please comment if you are aware of any sub-populations that may have atypical, unusually 

high exposure compared to the general population.

ENDANGERED SPECIES:

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

conducted for sulfometuron methyl. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether sulfometuron methyl use 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 sulfometuron methyl, 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), 

sulfometuron methyl 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. Sulfometuron 

methyl is not among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP 

orders/data call-ins, requiring the submission of EDSP screening assays for sulfometuron methyl 
12

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website8

.

HUMAN STUDIES:

Past sulfometuron methyl 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.

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