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 Division2 INTRODUCTION

This is the Environm ental 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 gol f 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 w hen the initial docket is opened for each case.

Informatio n 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 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 foramsulfuron

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The i mmunotoxicity data requirement is no longer required for fora msulfuron. 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 AN D 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 issu es. A summary of the comment and the Agency’s response are provided below

. The p ublic comment in its entirety is located in the docket, EPA

HQ

- OPP

- 2012

- 0387

.

1 http://www.epa.gov/oppsrrd1/registration_review/3 Comment submitted by the FIFRA Endangered Species Task Force in EPA

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- 2012

- 0387

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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 foramsulfur on 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 nee ds have changed from what was included in the PWP

. The Immunotoxicity study is no longer required.

Table 1: Planned D ata Needs for the Foramsulfuron Registration Review

Guideline

Number 2 Study Title 2 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.2410 Soil photolysis TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence 2 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor 2 TEP 12

850.4400 Aquatic plant toxicity, vascular plants 2 TEP 12

850.6100 Environmental chemistry methods and associated independent laboratory validation

for soil and water 2 TGAI 12

Non

guideline Plant reproduction 3 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 Av ailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 0028

3 Based in part on a review of previously submitted d ata 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 char acterize potential impacts of the sulfonyl urea her bicides 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 regard less 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

T able 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 doe s 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 to5 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 Assessments 4 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 D ata C all

- I n Notice , expected to be issued in 2014.