2 

### Rimsulfuron Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessment s for Registration Review 7

Timeline 8

Next Steps 9

Appendix

– Additional Areas Considered in Rimsulfuron ’s R egistration 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 Rimsulfuron . September 13, 2012

2. Rimsulfuron. Human Health Assessment Scoping Document in Support of Registration

Revie w. May 21, 2012

3. Biological and Economic Analysis Divi sion Chemical Profile for Registration Review: Rimsulfuron. April 5, 2012

4. Rimsulfuron: Review of Human Incidents. May 8, 2012

These and other supporting documents for the rimsulfuron registration review case may be found

in the docket EPA

- HQ

- OPP

- 2012

- 0178 at http://www.regulations.gov

.3 OVERVIEW

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

- HQ

- OPP

- 2012

- 0178 )

. Rimsulfuron i s a selective herbicide registered for use to control broadleaf and grassy weeds on various agricultural and

non

- agricultural food and non

- food sites. There are no registered residential uses. This Preliminary Work Plan (PWP) document explains what EPA's O ffice of Pesticide Programs

knows about rimsulfuron

, 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 rimsulfuron’s review

.

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 informatio n in the docket, to inform the public of what it knows about rimsulfuron and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on rimsulfuron

. The Agency encourages all interested stakehold ers 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, in stitutional, residential, and other users of pesticides; or the public at large.

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

. Next, it discusses the statutory and regulatory authority for R egistration R eview. T he n the document provides rimsulfuron chemical 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

R egistration R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for rimsulfuron

. There are no anticipated

human health data needs. For additional discussion of the anticipated data needs, see the September 13, 2012 Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Rimsulfuron and the May 21, 2012 Rimsulfuron. Human Health Assessment Scoping Document in Support of Registration Review

.

Anticipated Data Needs for the Registration Review of Rimsulfuron

Guideline

Nu mber Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835. 4400 Anaerobic aquatic metabolism 1 Degradates 24

835.6100 Terrestrial field dissipation study 2 TGAI and degradates 12

835.6200 Aquatic field dissipation study 2 TGAI and degradates 12

850.1350 Aquatic invertebrate life

- cycle (marine) 3 TGAI 12

850.1400 Estuarine/marine fish early life stage 3 TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence,

Tier II TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor, Tier

II TEP 12

The stud ies listed below w ere previously required and are under review. They will NOT be included in the anticipated Registration Review DCI. However, if the stud ies are not determined to be acceptable, the registrants will have to resubmit or upgrade them

.

835.4100 Aerobic Soil Metabolism TGAI and degradates In review

835.4300 Aerobic aquatic metabolism TGAI and degradates In review

850.1300 Aquatic invertebrate life

- cycle (freshwater) TGAI In review

850.1400 Freshwater fish early life

- stage TGAI In review

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

1 A study has been submitted that is scientifically valid but additional characterizat ion of secondary metabolites is anticipated to be required.

2 See footnote 7 of 40 CFR 158.1300. EPA anticipates requiring only the environmental chemistry analytical

met hods and independent laboratory (ILV) portions of this guideline for soil and water, rather than the full field dissipation study.

3 Results from the review of the submitted freshwater studies may negate the need for additional data.5 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 regis tered 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. Informatio n on this program is provided on EPA’s website 4

.

The Agency is implementing the registration review program pursu ant 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 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 i n 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 rimsulfuron.

RIMSULFURON CHEMICAL FACTS

PC code 129009

Case Number 7218

CAS Number 122931

- 48

- 0

Year first registered 1994 Pesticide Type Herbicide

Chemical class Sulfonylurea

R eregistration Eligibility Decision (R E D) Because it was registered after November 1984, rimsulfuron was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable

40 CFR Citation Tolerances for rimsulfuron are established in 40 CFR 180.478

Dual

- use Conventional pesticidal uses only

Non

- pesticidal uses None specifically for rimsulfuron, but sulfonlyureas are FDA approved for treatment of diabetes.

4 http://www.epa.gov/oppsrrd1/registration_review/6 Pesticide Re

- evaluation Division, Chemical Review Manager Jose Gayoso gayoso.jose@epa.gov (703) 347

- 8652 Registration Division

, Product Manager Kable Bo Davis davis.kable@epa.gov (703) 306

- 0415

USE AND USAGE INFORMATION

Please see the BEAD Chemical Profile for Registration Review: Rimsulfuron in the registration

review docket for more details

.

Summary of Use Selective herbicide registered for use to control pre

- plant, pre

emergence, and post

- emergence broadleaf and grassy weeds.

Use Sites Various crops, primarily corn, as well as various non

- crop uses, including non

- residential lawns and turfs, and uncultivated areas. Summary of Usage In 1998

- 2010, an average of 92,000 lbs. was applied per year to agricultural crops . The top agricultural crops were corn, potatoes, tomatoes, and almonds. Until recent years, agricultural usage was in

decline since 2004.

National level u sage data for non

- agricultural uses are not available.

Formu lation Type(s) Water dispersible granules (dry flowable), emulsifiable concentrates, soluble concentrates/solids. Application Method(s) Aerial and ground (broadcast, band, chemigation) Technical Registrant (s) DuPont, Cheminova, Quena Plant Protection

No . of Registrations 36 Section 3 registrations 5

Restricted Use There are two restricted use products with the active ingredient rimsulfuron. Registrations 352

- 585 and 352

- 619 are coformulated

with atrazine and are Restricted Use Pesticides due to ground and

surface water concerns.

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.

• Usage/use information for non

- agricultural 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 ; geographic li mitations 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 applica tion and application intervals)

– national, state, and county

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).7 • Typical application interval (days)

• S tate or local use restrictions

• F oreign technical registrants not listed above who supply technical rimsulfuron to the US

market

RECENT ACTIONS

A tolerance on chicory was established on August 3, 2012 ( FRL

- 9355

- 5 ).

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for rimsulfuron was completed on May 4, 2012 for a registration related new use req uest for use on chicory. T he most recent ecological and environmental fate risk assessment was completed March 20, 2012 for the same

purpose . Findings and conclusions from these risk assessments are summarized in the September 13, 2012 Registration Review : Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Rimsulfuron and the May 21, 2012 Rimsulfuron. Human Health Assessment Scoping Document in Support of Reg istration 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

rimsulfuron. For human health, EPA anticipates the need to conduct revised residential and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration revie w
, they will be considered in the new assessment s
, as well as any changes to the standard operating

p rocedures or default exposure assumptions

.

The table below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formu lation and HED Scoping Document

.

Anticipated Risk Assessments for Rimsulfuron’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 Y

Incidents Y For a discussion of rimsulfuron’s reported ecological incidents, see page 22 of the Problem Formulation.

Human Health Dietary

Food N Drinking water N8 Occupational Handlers (m ixer s, loader s, applicators ) Y Occupational handler exposure and risk assessments are anticipated for the following uses: golf course, sod farms athletic fields, industrial and commercial lawns

and similar nonresidential areas; agricultural food crops including soybeans, potatoes, field corn, tomatoes, grapes, various tree fruits, and tree nuts.

Post

- application Y Occupational post

- application exposure and risk

assessments are a nticipated for the following uses: soybeans, potatoes, field corn, tomatoes, grapes, various tree fruits, tree nuts, and golf course turf.

Residential

Handlers N

Post

- application Y Based on the current use patterns, there is only potential for post

- application dermal exposure for recreational golfers. Therefore, a new risk assessment is anticipated for the existing golf course turf use.

Other Aggregate Y A new aggregate assessment may be needed to

include the short

- term dermal exposure for the recreational golfer.

Cumulative N

Tolerances N

Incidents Y For a discussion of rimsulfuron’s reported human incidents, see page 7 of the Scoping Document.

TIMELINE

EPA has created the following estimated timeline for the completion of rimsulfuron’s registration review

.

Registration Review for Rimsulfuron

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period 2012

– September

Close Public Comment 2012

– November Case Development

Final Work Plan 2013

– February

Issue DCI 2013

– Oct.

- Dec.

Data Submission 2015

– Oct.

- Dec. Open 30

- day Public Comment Period for Draft Risk Assessments 2017

– April

- June

Close Public Comment Period 2017

– July

- Sept. Registration Review Decision9 Registration Review for Rimsulfuron

– Projected Registration Review Timeline

Activities Estimated Date Open 60

- day Public Comment Period for Proposed Registration Review

D ecision 2017

– Oct.

- Dec.

Close Public C omment P eriod 2018

– Jan.

- March 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 rimsulfuron.10 

### Appendix

– Additional Areas Considered in Rimsulfuron’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 sou rces of additional information c ould 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.

Water Quality:

Rimsulfuron is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 6

. In addition, n o Total Maximum Daily Load s (TMDL) have been developed for rimsulfuron 7 . More information on impaired water bodies and

TMDLs can be found at the Agency’s website 8

. 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 9 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 popula tion who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to rimsulfuron compared to the general population. Please comment if you are aware of any sub

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

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

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

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

9 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm11 ENDANGERED SPECIES :

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

conducted for rimsulfuron. The ecological risk assessment planned during registration review will allow the Agency to determine whether rimsulfuron’s 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 ap propriate.

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, i ncluding 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 histopatholo gy, 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 repr oductive effects in different taxonomic groups. As part of its most recent registration decision for rimsulfuron 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),

rimsulfuron 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 o ther 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 statutor ily 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 screenin g 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. Rimsulfuron 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 rimsulfuron.12 For further information on the status of the EDSP, the po licies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website 10

.

HUMAN STUDIES :

Occupationa l

Past rimsulfuron 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 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 f or 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.

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