2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of sulfometuron methyl . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the sulfometuron methyl registration review docket (EPA

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- 0433 ). Sulfometuron methyl is a sulfonylurea herbicide. It is a non

- food/non

- feed use ch emical 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).

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 stand ard for registration. Changes in science, public policy, and pesticide use practices occur over time. 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. The public phase of registration review begins when the initial docket is opened for each case.

Informatio n on this program is provided on the Agency’s website

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The FWP begins with any updates since the PWP was issued. Next is a summary of substantive

comments received during the public comment period for the PWP concerning anticipated data

needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a

summ ary of the Agency’s response s to th o se comments

. This section is followed by registration

review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for sulfometuron methyl

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on sulfometuron methyl since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Sulfometuron Methyl Preliminary Wor k Plan

, which opened on December 14, 2012 and closed on February 12, 2013 , the Agency received five public comments. Comments were submitted by the technical registrant DuPont and the FIFRA Endangered Species Taskforce (FESTF) . The comments address the p lanned ecological an d human health risk assessments, data requirements , use and usage information, and water quality

concerns . In the PWP, EPA also solicited comments on the specific topics of environmental justice and trade irritants, but no comments or information were received on those issues.

This section does not capture every comment made about the PWP nor all of the Agency’s

responses. Summarized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory

nature. Public comments and EPA responses in their entirety are located in the docket, EPA

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1 http://www.epa.gov/oppsrrd1/registration_review/3 HQ

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- 0433 . Summarized public comments and Agency responses rel ated to the anticipated ecological risk assessment are in the Response to DuPont Crop Protection Comments regarding EFED Problem Formulation on the Registration Review of Sulfometuron (D409662)

while those relevant to the anticipated human health risk asse ssment are in the Sulfometuron Methyl: Response to Comments for the Human Health Scoping Document in Support of Registration Review (D409661)

.

Comments submitted by FIFRA Endangered Species Task Force (FESTF) in EPA

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1. Comment: FESTF submitted a comment that sulfometuron methyl technical registrants DuPont and Nufarm Limited are members of the FESTF task force and are entitled to rely on data submitted by FESTF

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Response: The Agency thanks FESTF for its comment and will consid er this information as it conducts the registration review process and makes its registration review decision.

Comments submitted by the technical registrant Du P ont in EPA

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3. Comment: DuPont informed the Agency of international uses and proposed uses of sulfometuron methyl

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Response: The Agency appreciates this information and will consider this information as it conducts the registration review process and makes its registration review decision.

4. Comment: DuPont offered some corrections to use estimates for lawn care operators cited in the BEAD Chemical Profile for Registration Review

.

Response: The Agency appreciates this information and will consider this information as it conducts the registration revi ew process and makes its registration review decision.

5. Comment: DuPont wants to ensure that sulfometuron methyl’s rangeland restoration use is included in future risk assessments conducted to support registration review.

Response : The Agency will c onduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of s ulfometuron methyl. For human health, if exposure or toxicological estimates change, EPA may revise dietary, residential, and occupational risk assessments during registration review.

6. Comment: DuPont note d that the PWP incorrectly state s that sulfometuron methyl is not labeled for agricultural uses. DuPont point s out that sulfometuron methyl containing products are registered for use in forestry, conifer and hardwood cultivation, and rangeland restoration. All of these uses are considered a gricultural crops and regulated under the Worker Protection Standard for Agricultural Workers.

Response: The Agency appreciates this clarification an d will correct this use distinction

in future documents.4 7. Comment: DuPont commented that it is unaware of any ecological incident or water quality monitoring data for sulfometuron methyl which has not already been reported to the Agency in

accordance with FIFRA 6(a)(2). DuPont also intends to continue reporting all incidents in compliance with FIFRA reporting requirements. Specifically regarding water quality monitoring data, DuPont has become aware of water quality monitoring data and DuPont has

repo rted this data to EPA in accordance with FIFRA 6(a)(2). Since there is no established maximum contaminant levels ( MCL s) for sulfometuron methyl all detections have been reported as Category "G

- C" in accordance with regulations. Since 1998 there have been s even reported detections. These reports reflect second

- hand information received from state regulatory agencies and other individuals. DuPont does not have any self

- generated water quality monitoring data.

Response: EPA appreciates DuPont sharing this in formation.

Comments submitted by the technical registrant DuPont in EPA

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8. Comment : DuPont c omment ed on EPA ’s classification of sulfometuron methyl as toxicity category III based on a 1980 eye irritation study in rabbits ( MRID 00071412 ) . This 1980 study

was conducted with a 75% formulation and has recently been repeated with a 99.1% technical grade sulfometuron methyl (MRID 416 7 2807). The more recently conducted study ( MRID

41672807 ) demonstrates sulfometuron methyl is less of an ocular irritant than previously demonstrated by the 1980 study (MRID 00071412)

. DuPont requests that the Agency review the newer eye irritation study and reconsider sulfometuron methyl’s toxicity classification.

Response: EPA will review the above r eferenced study (MRID 416 7 2807) and consider it for use in classification of eye irritation for sulfometuron methyl.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for s ulfometuron methyl based on the Registration Review: Preliminar y 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

. The planned data needs have not changed from what was

included in the PWP

.5 Table 1. Planned Data Needs for Sulfometuron Methyl’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

850 .6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation for S oil and

W ater 2 TGAI & Degradates 3 12

835.4100 Aerobic S oil M etabolism TGAI & TEP 24

870.7800 Immunotoxicity Study TGAI 12
TGAI = technical grade active ingredient; TEP = typical end

- use product ;

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of s ulfometuron methyl

. For human health, EPA will conduct revised dietary, residential

, and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the

data that are required for regis tration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

Table 2 below summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.

Table 2. Planned Risk Assessments for Sulfometuron Methyl’s Registration Review

Type of Risk Assessment Conduct? Notes

Eco l ogical 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.

2 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

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3 Environmental chemistry methods should be submit ted with their associated independent laboratory validations for parent sulfometuron methyl and its major degradates sulfometuron pyrimidine amine (IN

- X0993), sulfometuron sulfonamide (IN

- D5803), and saccharin (IN

- 581) in water and soil.6 Incidents Yes The planned assessment will consider ecological incidents attributed to sulfometuron methyl use. 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 May be updated and will reflect any revisions or updates to the toxicological endpoints.

Occupational 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 t his time.

If post

- application 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.7 Incidents The planned assessment will consider human incidents attributed to sulfometuron methyl use. For a

discussion of sulfometuron methyl’s reported human incidents, see Sulfometuron Methyl: Review of Human

Incidents in docket EPA

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TIMELINE

EPA has created the following estimated timeline for th e completion of the s ulfometuron methyl registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Sulfometuron M ethyl

– 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

- May

Issue DCI 2014

- Jan.

- Mar.

Data Submission 2016

- Jan.

- Mar.

60

- day Public Comment Period for Draft Risk Assessments 4 2017

- Jul.

- Sep. Registration Review Decision

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

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for s ulfometuron methyl through a D ata C all

- I n Notice , expected to be

issued in early 2014.

4 The regulations governing Registration Review 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). The Agency plans to provide a 60 calendar day public comment period for draft risk asse ssment s as a general standard of practice

.