Docket Number EPA-HQ-OPP-2012-0387 

www.regulations.gov 

Foramsulfuron Final Work Plan 

Registration Review 

Case Number 7252 

June 2013 

Approved by: ::o 

Date: 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 
2

INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of foramsulfuron. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the foramsulfuron

registration review docket (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.

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. 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. 

Information on this program is provided on the Agency’s website.

1

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 

summary of the Agency’s responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected

registration review timeline for foramsulfuron. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The immunotoxicity data requirement is no longer required for foramsulfuron. The Agency 

decided that such data would be unlikely to result in a Point of Departure (POD) based on the 

lack of toxicity observed in the database and the low concern for sulfonylurea herbicides as a 

class to target the immune system. Therefore, the current toxicology database for foramsulfuron 

is adequate to assess risk to human health. Furthermore, the Agency does not plan to conduct an 

occupational handler risk assessment since no new human health data will be required.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Foramsulfuron Preliminary Work Plan, which 

opened on December 14, 2012 and closed on February 12, 2013, the Agency received one public 

comment from the FIFRA Endangered Species Task Force. The comment does not address the

timeline described in the PWP. In the PWP, EPA also solicited comments on the specific topics 

of environmental justice, water quality concerns, and trade irritants, but no comments or 

information were received on those issues. A summary of the comment and the Agency’s 

response are provided below. The public comment in its entirety is located in the docket, EPAHQ-OPP-2012-0387. 

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

Comment submitted by the FIFRA Endangered Species Task Force in EPA-HQ-OPP-2012-

0387-0009.

1. Comment: The FIFRA Endangered Species Task Force (FESTF) submitted a comment 

informing the Agency that the technical registrant for foramsulfuron is a member of the 

FESTF and is entitled to rely on FESTF data on endangered species proximity to 

foramsulfuron uses.

Response: The Agency thanks FESTF for its comment and will take this under consideration.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for foramsulfuron based on 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. The planned data needs have 

changed from what was included in the PWP. The Immunotoxicity study is no longer required.

Table 1: Planned Data Needs for the Foramsulfuron Registration Review

Guideline 

Number2 Study Title2

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.2410 Soil photolysis TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence2 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor2 TEP 12

850.4400 Aquatic plant toxicity, vascular plants2 TEP 12

850.6100

Environmental chemistry methods and 

associated independent laboratory validation 

for soil and water2

TGAI 12

Nonguideline Plant reproduction3 TGAI 12

TGAI = technical grade active ingredient; TEP = typical end-use product;

 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028

3 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.
4

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will 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. This is a 

change in the planned assessments from what was included in the PWP. Since no new human 

health data will be required, the Agency does not plan to conduct an occupational handler risk 

assessment. Table 2 below summarizes the planned registration review risk assessments.

Table 2: Planned Risk Assessments for the Foramsulfuron 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 Will check for 

updates

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)

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.

Residential

Handlers N Based on lack of observed toxicity regardless of route 

of exposure, EPA does not anticipate the need to 
5

Table 2: Planned Risk Assessments for the Foramsulfuron Registration Review

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

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 Will check for 

updates

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.

TIMELINE

EPA has created the following estimated timeline for the completion of the foramsulfuron

registration review in Table 3 below. The projected timeline has not changed since the PWP. 

Table 3: Registration Review for Foramsulfuron – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period December 2012 - Completed

Close Public Comment February 2013 - Completed

Case Development

Final Work Plan June 2013 - Completed

Issue DCI 2014 – Jan – March

Data Submission 2015 – Jan – March

60-day Public Comment Period for Draft Risk Assessments4 2016 – July – Sept.

Registration Review Decision

 4 The regulations governing Registration Review generally 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). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
6

Table 3: Registration Review for Foramsulfuron – Projected Registration Review Timeline

Activities Estimated Date

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

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

effects studies for foramsulfuron through a Data Call-In Notice, expected to be issued in 2014.