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 Assessments for Registration Review 7

Timeline 10

Next Steps 10

Appendix – Additional Areas Considered in Foramsulfuron’s Registration Review 11

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 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 Chemical 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.
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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 Preliminary 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 conducting 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 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 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, 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 Registration Review. 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 Registration Review 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 photolysis TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence1 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor1 TEP 12

850.4400 Aquatic plant toxicity, vascular plants1 TEP 12

850.6100

Environmental chemistry methods and 

associated independent laboratory validation 

for soil and water1

TGAI 12

870.7800 Immunotoxicity TGAI 12

Nonguideline Plant reproduction2 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 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 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 studies for each sulfonyl urea herbicide is 

unnecessary. The previously submitted data provide sufficient information for EPA to characterize potential impacts 

of the sulfonyl urea herbicides on plant reproduction. Therefore, to satisfy this requirement, registrants 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 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 website3.

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 

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 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

Reregistration Eligibility 

Decision (RED)

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 tolerance 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) 306-0415

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 Agricultural registered uses include field corn, sweet corn, and 

popcorn. Non-agricultural registered 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 Types Emulsifiable concentrates.

Application Methods Ground applications with tractor mounted ground sprayers and 

aerial applications.

Technical Registrant Bayer Cropscience

No. of Registrations Section 3 products4: 5

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 

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

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

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/A) 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 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 Notice 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 cancel 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. The 

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 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. 

During registration review, the 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 

assessments 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.
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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 degradates , 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 Based 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 Based 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 (mixers, loaders, 

applicators)

TBD Based 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 Based 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.

Residential

Handlers N Based 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 Based 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.

Other
9

Aggregate N Since there are no dietary or residential risks, the 

Agency does not anticipate evaluating 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 

substances 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 does 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 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)

• 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 clarifications including maximum number of applications per year, maximum 

application rate per year, and the minimum application treatment interval
10

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 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 foramsulfuron.
11

Appendix – Additional Areas Considered in Foramsulfuron’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 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 bodies listed as impaired 

under section 303(d) of the Clean Water Act5

. In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for foramsulfuron6

. More information on impaired water bodies 

and TMDLs can be found at the Agency’s website7. 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 Process8 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_

group_name=PESTICIDES 7 http://www.epa.gov/owow/tmdl/

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
12

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 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.

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 Protection 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 threatened 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 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 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 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 
13

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. 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 callins, requiring 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 website9.

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 assessments were not conducted.

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