2 Foramsulfuron 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 10

Next Steps 10

Appendix

– Additional Areas Considered in Foramsulfuron’s Registration Review 1 1

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 the Ecological Exposure and Risk Assessment for Foramsulfuron. November 15, 2012

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

Review

. November 8, 2012

.

3. BEAD C hemical Profile for Registration Review: Foramsulfuron

. July 5, 2012

.

4. Foramsulfuron: Review of Human Incidents

. July 19, 2012

.

5. Foramsulfuron Screening Level Usage Analysis

. January 10, 2012

6. Foramsulfuron Label Data Report

. May 31, 2012

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

found in the docket EPA

- HQ

- OPP

- 2012

- 0387 at http://www.regulations.gov

.3 OVERVIEW

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

- HQ

- OPP

- 2012

- 0387 )

. Foramsulfuron is a selective herbicide registered for use on corn and non

- agricultural sites, such as golf courses and residential lawns, to control post

- emergent grass and broadleaf weeds. Foramsulfuron belongs to the sulfonylurea herbicide family. This P reliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about foramsulfuron , highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conduc ting the review, and providing an anticipated timeline for completing

foramsulfuron’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 foramsulfuron and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on

foramsulfuron. The Agency encourag es 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

commo dity 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 foramsulfuron. Next, it discusses the statutory and regulatory authority for R egistration R eview

. Then the document provides foramsulfuron’s 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

Table 1 below summarizes anticipated data needs for foramsulfuron. For additional discussion of the anticipated data needs, see the November 15, 2012 Registration Review

– Preliminary Problem Formulation for the Ecological Exposure and Risk Assessment for Foramsulfuron and the November 8, 2012 Foramsulfuron. Human Health Assessment Scoping Document in Support of Registration Review

.

Table 1 : Anticipated Data Needs for Foramsulfuron’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.2410 Soil p hotolysis TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence 1 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor 1 TEP 12

850.4400 Aquatic plant toxicity, vascular plants 1 TEP 12

850.6100 Environmental chemistry methods and

associated independent laboratory validation

for soil and water 1 TGAI 12

870.7800 Immunotoxicity TGAI 12

Non

guideline Plant reproduction 2 TGAI 12

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 chan ges 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 Based in part on a review of previously submitted data for another sulfonyl urea herbicide, the Agency has determined that generation of new non

- guideline plant reproduction s tudies for each sulfonyl urea herbicide is

unnecessary. The previously submitted data provide sufficient information for EPA to characterize potential impacts of the sulfonyl urea her bicides on plant reproduction. Therefore, to satisfy this requirement, re gistrants may wish to consider citing these existing data in response to the DCI.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 scientif ic 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 a nd 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 r egistration 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 3

.

The Agency is implementing the regist ration 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 r egulations 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 in the doc ket 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 foramsulfuron.

Table 2 provides a summary of the current regulatory status of foramsulfuron

.

Table 2: FORAMSULFURON CHEMICAL FACTS

PC code 122020

Case Number 7252

CAS Number 173159

- 57

- 4

Year first registered 2002 Pesticide Type Herbicide

Chemical class Sulfonylurea

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

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not part of a cumulative risk assessment.

40 CFR Citation A t olerance exemption for foramsulfuron is established in 40 CFR

180.1219

. Tolerances have been established for isoxadifen

- ethyl, a safener

found in two foramsulfuron products, in 40 CFR 180.570.

3 http://www.epa.gov/oppsrrd1/registration_review/6 Dual

- use Conventional pesticidal uses only.

Non

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

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

- 04 15

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for foramsulfuron. Please see the July 5, 2012 BEAD Chemical Profile for Registration Review: Foramsulfuron in the registration review

docket for more details

.

Table 3: USE AND USAGE INFORMATION Summary of Use Selective herbicide registered for post

- emergent control of annual and perennial grass and broadleaf weeds.

Use Sites Agricult ural registered uses include fiel d corn

, sweet corn , and

popcorn . Non

- agricultural register ed uses include golf courses, sports fields, home and commercial lawns, cemeteries, parks, recreational areas, roadsides, school grounds, and sod farms. Summary of Usage From 2002

- 2010, the annual total agricultural usage of foramsulfuron averaged approximately 17,000 pounds a.i. . Less than one percent of the corn crop is treated annually.

The main non

- agricultural use of foramsulfuron is on golf courses. The reported amount of foramsulfuron used on golf courses approximately doubled from 500 lbs. a.i. in 2004 to 1,000 lbs. a.i. in 2006. Usage data on other non

- ag uses are not available. Formulation Type s E mulsifiable concentrate s. Application Method s Ground applications with tractor mounted ground sprayers and aerial applications.

Technical Registrant Bayer Cropscience No. of Registrations Section 3 products 4 : 5

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 ; formulations ; application methods and equipment ; maximum application rates ; frequency of

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

( http://oaspub.epa.gov/pe stlabl/ppls.home ).7 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/ A ) 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 technical registrants not listed above who supply technical foramsulfuron to the

US market

RECENT ACTIONS

Foramsulfuron product Tribute Solo WB32 Herbicide, registration number 264

- 686, is undergoing voluntary cancellation. The Federal Register No tice for this request ( FRL

- 9351

- 8 ) was published on July 6, 2012. Unless the Agency receives substantive comments by January 2, 2013, which is the end of the 180

- day comment period , or unless the registrant withdraws its request, the Agency intends to canc el the product at the end of the comment period

.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for foramsulfuron was completed

on December 20, 2006 for a registration

- related new use request for sweet corn and popcorn. T he most recent ecological and environmental fate risk assessment was completed on September 21,

2006 for the same purpose

. Findings and conclusions from these risk assessments are

summarized in the November 15, 2012 Reg istration Review

– Preliminary Problem Formulation for the Ecological Exposure and Risk Assessment for Foramsulfuron and the November 8, 2012 Foramsulfuron Human Health Assessment Scoping Document in Support of Registration Review.

During registration re view, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of

foramsulfuron. For human health, based on lack of observed toxicity regardless of route of

exposure, EPA does not anticipate the need to conduct any updated human health risk

assessment s during registration review

. However, an occupational handler risk assessment may be conducted pending the results of the anticipated immunotoxicity study.

Table 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.8 Table 4: Anticipated Risk Assessments for Foramsulfuron’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 Y The ecological risk assessment may consider risk

from isoxadifen

- ethyl, a safener found in the two foramsulfuron products registered for use on corn

.

The risk assessment may also consider risk from major degradate s , such as AEF130619 and F0338795. See Table 8 on page 9 of the Problem Formulation for a list of major degradates.

Incidents Y For a discussion of foramsulfuron’s reported ecological incidents, see page 17 of the Problem

Formulation.

Human Health Dietary

Food N B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to conduct any updated human health risk assessments during registration review. Drinking water N B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to conduct any updated human health risk assessments during registration review. Occupational Handlers (m ixer s, loader s, applicators ) TBD B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to conduct any updated human health risk assessments during registration review. However, an occupational handler risk assessment may be conducted pending the results of the anticipated immunotoxicity study.

Post

- application N B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to

cond uct any updated human health risk assessments during registration review.

Residential

Handlers N B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to conduct any updated human health risk assessments during registration review.

Post

- application N B ased on lack of observed toxicity regardless of route of exposure, EPA does not anticipate the need to conduct any updated human health risk assessments during registration review.

Other9 Aggregate N Since there are no dietary or residential risks, the Agency does not anticipate e valuat ing the combined risk from dietary and residential exposures.

Cumulative N The Agency has not made a common mechanism of toxicity finding as to foramsulfuron and any other

su bstances and foramsulfuron does not appear to produce a toxic metabolite produced by other

substances.

Tolerances N Foramsulfuron is exempt from tolerances.

Incidents N Based on the low frequency of incident cases reported for foramsulfuron, there d oes not appear to be a

concern at this time that would warrant further investigation into human incidents. For a discussion

of foramsulfuron’s reported human incidents, see

page 6 of the Scoping Document.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , 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)

• Major degradate toxicity data

• Information regarding effects of foramsulfuron on plant reproduction (e.g., fruit numbers, seed numbers, volume and weight of seed, number of flowers)

• Label clar ifications including maximum number of applications per year, maximum application rate per year, and the minimum application treatment interval10 TIMELINE

EPA has created the following estimated timeline for the completion of foramsulfuron’s registration review in Table 5 below

.

Table 5: Registration Review for Foramsulfuron

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2012

- December

Close Public Comment 2013

- February Case Development

Final Work Plan 2013

- May

Issue DCI 2014

– Jan

– March

Data Submission 2015

– Jan

– March

30

- day Public Comment Period for Draft Risk Assessments 2016

– July

– Sept. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 2017

– Jan

– March

Registration Review Decision and Begin Post

- Decision Follow

- up 2017 Total (years) 5

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 foramsulfuron.11 Appendix

– Additional Areas Considered in Foramsulfuron’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 re view 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 (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 markets, providing as much specific ity as possible regardi ng the nature of the concern. Because foramsulfuron is exempt from tolerances, the Agency does not anticipate any trade irritant issues for it.

Water Quality:

Foramsulfuron is not identified as a cause of impairment for any water b odies listed as impaired under section 303(d) of the Clean Water Act 5

. In addition, no Total Maximum Daily Loads (TMDL) have been developed for foramsulfuron 6

. More information on impaired water bodies and TMDLs can be found at the Agency’s website 7

. The A gency 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 8 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 foramsulfuron 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.

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

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

gr oup_name=PESTICIDES

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

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12 ENDANGERED SPECIES :

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

conducted for foramsulfuron. The ecological risk assessment planned during registration review will allow the Agency to determine whether foramsulfuron’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their desi gnated 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 Se rvices), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network

North America filed a lawsuit in the United States District Court for the Northern District of California, against the Environmental Protect ion Agency (EPA) for allegedly failing to undergo

consultation with the United States Fish and Wildlife Service and the National Marine Fisheries Service regarding the effects of over 350 pesticides, including foramsulfuron, on over 200 endangered and thre atened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C 11

- 00293 (N.D.Cal.).

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential advers e 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 ecol ogical 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 foramsulfuron 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),

foramsulfuron 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 inte ract 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

wil l 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 October13 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingred ients and 9 inert ingredients

. Foramsulfuron 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, requirin g the submission of EDSP screening assays for foramsulfuron. 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 webs ite 9

.

HUMAN STUDIES :

EPA risk assessments for the herbicide foramsulfuron do not rely on data from studies in which human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure, since quantitative exposure as sessments were not conducted.

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