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 Assessment s for Registration Review 7

Timeline 9

Next Steps 9

Appendix

- Additional Areas C onsidered in Sulfometuron Methyl ’s Registration Review

10

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 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 s ulfometuron m ethyl 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 wa y, non

- crop industrial sites, and unimproved turf). This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about s ulfometuron m ethyl

, 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

s ulfometuron m ethyl ’s review

.

The registration review process was designe d 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 s ulfometuron m ethyl 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 m ethyl

. The Agency encourages all interested stakeholders to review

the PWP and Appendix and to provide comments and additional information that will hel p the Agency’s decision

- making process for s ulfometuron m ethyl . 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 Preli minary Work Plan begins by listing the anticipated data needs for sulfometuron m ethyl

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides s ulfometuron m ethyl ’s f acts, 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 R egistration R eview along with som e additional s ulfometuron m ethyl case

- specific

information.4 ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for s ulfometuron m ethyl . 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

water 1 TGAI 2 4

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 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 2

.

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

. T he Agen cy 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 A vailability” 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 wha t 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 ina l W ork P lan (FWP) and anticipated schedule for the registration review of s ulfometuron m ethyl

.

SULFOMETURON METHYL FACTS

PC code 122001

Case Number 3136

CAS Number 74222

- 97

- 2

Year first registered 198 2 Pesticide Type Herbicide Sulfometuron Methyl

class Su l fonylurea

R eregistration Eligibility Decision (R E D) 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 deta ils

.

Summary of Use Sulfometuron met hyl is a sulfonyl urea 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.

Use Sites N on

- 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, dr ainage 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 meth yl by6 lawn care operators totaling an estimated 38,000 lbs. a.i. (Kline and Com pany, Inc., 2006). Sulfometuron methyl was

c onsidered 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 Type s Sulfometuron methyl is formulated as a water dispersible granular

and soluble concentrate. Application Method s Sulfometuron methyl is applied using ground or aerial appli cation

methods. Technical Registrant s Celsius Property B.V., E.I. DuPont de Nemours and Company,

NuFarm Limite d No. of Registrations Approx imately 19 FIFRA Section 3 registrations 3 and no FIFRA Section 24(c) registrations

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.

• C onfirmation of the following label information : sites of application ; formula tions ; 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 percentile reported use rates (lbs ai/ 1000 sq ft ) from usage data

– national, state, and county

• A pplication timing (date of first application and application intervals)

– national, state,

and county

• Usage/use information for non

- agricultural uses

• Typical application interval (days)

• S tate or local use restrictions

• F oreign or domestic technical registrants not listed above who supply technical

s ulfometuron m ethyl to the US market

RECENT ACTIONS

The revised RED for s ulfometuron m ethyl was completed in December 200 9

. 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

- OPP

2008

- 0194 at www.regulations.gov

.

3 Section 3 product labels can be obtained from the Pesticide Produ ct 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 s ulfometuron m ethyl was completed in August 2008 to support the RED

. T he most recent ecological and environmental

fate risk assessment s w ere 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

su mmarized 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, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of

s ulfometuron m ethyl

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

the residential and occupational risk assessment s 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 a re anticipated to be required for registration

review

, or any changes to the standard operating p rocedures 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

Eco logical 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 s ulfometuron m ethyl ’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. Occupational8 Handlers (m ixer s, loader s, applicators ) No Based upon c urrent 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 occup ational

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 E valuates 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 Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring data (see Appendix for further details)

.

Additional use information requested for this registration review, and of particular interest to EPA, is described below.

• Information ab o ut the use of sulfometuron methyl on non

- agricultural sites such as: ornamental forest trees, loading docks (outdoor), and storag e areas (outdoor).9 TIMELINE

EPA has created the following estimated timeline for the completion of s ulfometuron m ethyl ’s registration review

.

Registration Review for Sulfometuron Methyl

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket 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

D ecision 2018

- Jan.

- Mar.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 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 s ulfometuron m ethyl

.10 

### Appendix

– Additional Areas Considered in Sulfometuron Methyl ’s 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 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 r esidue 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 and MRLs in key export market s, 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 Act 4

. In addition, n o Total Maximum Daily

Load s (TMDL) have been developed for sulfometuron methyl 5 . More information on impaired

water bodies and TMDLs can be found at the Agency’s website 6

. 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 7 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 en forcement 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 f actors, 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.htm11 Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

ENDAN GERED 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 desi gnated 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 syste mic 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,

an d 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 sul fometuron 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 scr eening 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 ident ify 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 p roceed 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

c hemicals, 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 methyl12 For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test g uidelines and the Tier 1 screening battery, please visit our

website 8

.

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 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 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

.

8 http://www.epa.go v/endo/