2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of bromacil

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in bromacil’s registration review docket (EPA

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- 0445 ). Bromacil is a broad

- spectrum herbicide registered for use to control weeds in the agricultural food crops citrus and pineapple. The lithium salt is not registered for agricultural uses; though both bromacil and its lithium salt are registered for use to control weeds and brush in several nonagricultural use sites.

The Agency is implementing the re gistration 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.

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

summ ary of the Agency’s response s to th o se comments

. This section is followed by bromacil’s registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There have been no updates since the PWP was issued.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

EPA published the Bromacil Preliminary Work Plan for a 60

- day public comment on Ju ly 6

, 2012 . The Federal R egister Notice announcing the docket opening 2 erroneously listed the comment period end date as August 19, 2012. However, on July 10, 2012, EPA extended the comment period until September 10, 2012 to allow for a full 60

- day public comment period. T he Agen cy received three public comments from DuPont Crop Protection . The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicit ed comments on the specific topics of environmental justice, water quality concerns , and trade irritants, but no

comments or information were received on those issues.

This section does not capture every comment made on the PWP nor all of the Agency’s

responses. Summarized below are public comments that resulted in changes to the anticipated

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

2 See 77 FR 40048; FRL

- 9352

- 1.3 registration review data needs, risk assessments, or timeline, or are of a broader regulatory

nature. Public comments and EPA responses in their enti rety are located in the docket, EPA

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- 2012

- 0445 . Summarized public comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the Response to Comments Submitted to the Bromacil Registration Review Docket (Docket ID: EPA

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- 2012

- 0445; Case #0041) while those relevant to the anticipated human health risk assessment or data needs are in

the Bromacil: Response to Comments on the Human

- Health Assessment Scoping Document and Preliminary Workplan

.

Comment s submitted by DuPont Crop Protection (DuPont) in EPA

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- 2012

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- 0010.

1. Comment: The Agency received a comment from DuPont regarding the toxicology database.

DuPont states that bromacil had been re

- evaluated for potential neurotoxicity to roden ts and

non

- rodents in acute, subchronic, and chronic studies . DuPont believes that based on the available data for bromacil as well as a structure

- activity relationship comparison, it can be concluded that bromacil is not a neurotoxin and the neurotoxicity screening battery can be

waived.

EPA Response: Based on a weight

- of

- evidence approach of all available hazard and exposure information for bromacil, the Agency’s Hazard and Science Policy Council (HASPOC) concluded on November 8 th , 2012 that acute and subchronic neurotoxicity studies are not required for bromacil at this time.

Comments submitted by DuPont Crop Protection in EPA

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- 0011.

2. Comment: DuPont agrees to perform an acute avian toxicity study with bobwhite quail at the

maximu m label rate for use in the risk assessment if requested in a Data Call

- In Notice.

EPA Response: The Agency thanks DuPont for their comment and will review the acute avian toxicity study upon receipt.

3. Comment: DuPont disagrees that tests need to be repeated for the seedling emergence and vegetative vigor studies, even though the original studies submitted utilized technical grade product instead of the required typical end

- use product (TEP).

EPA Response: The Agency believes TEP is sti ll nee ded for said studies as the formulated product contains detergents (surfactants) that are designed to enhance the toxicity of the active ingredient through facilitated uptake and/or transport. In addition, this request is supported by 37 reported incident s involving bromacil and terrestrial plants. As bromacil is an herbicide, an accurate measure of toxicity under field conditions is required in order to design effective mitigation for non

- target terrestrial plants.4 Comments submitted by DuPont Crop Protection in EPA

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- 0012.

4. Comment: DuPont references an open literature study (Sarmah et al., 2009) that they believe might fulfill GDLN 835 .4100

– Aerobic Soil Metabolism

.

EPA Response: The Agency thanks DuPont for their comment and recommends DuPont formally submit the referenced study if Agency review is desired. The Agency will evaluate the study upon receipt and determine its suitability for use in the risk assessment. If found acceptable this study would fulfill the requiremen t for GDLN 835.4100, and DuPont should respond to the DCI with the option to cite an existing study. If however, the study is determined to provide no additional useful information, the Agency will apply the conservative approach discussed in the problem formulation of multiplying the single available degradation half

- life (MRID 40951510) by three to account for potential variability in degradation rates among different soil types.

5. Comment: DuP ont agrees with the Agency that additional data may not significantly alter the conservative nature of the assumed sorption coeffic ient for bromacil. DuPont cite s that reported open literature shows nearly identical values to the database cited in EFED’s

Problem Fo rmulation.

EPA Response: DuPont should formally submit the referenced open literature studies to the Agency if they would like these data to be considered at the time of the risk assessment. The Adsorption/Desorption, Batch Equilibrium Study (Guideline 835.1230) noted in the PWP as an anticipated data need will no longer be included in the registration review data call

- in.

6. Comment: DuPont agrees to consider providing an aerobic aquatic metabolism study [Guideline 835.4300] if such a requirement is included in the Data Call

- In.

EPA Response: The Agency will review an aerobic aquatic metabolism study upon receipt. If this study is unacceptable or if DuPont does not submit a study, the Agency would make the conservative assumption that bromacil is stable to microbial degradation in the risk

assessment.

7. Comment: DuPont suggests that an open

- literature laboratory study (Wolf and Martin, 1974 publication ) may fulfill the anaerobic aquatic metabolism data requirement [Guideline 835.4400]. If said study was found un acceptable, DuPont would consider providing an anaerobic aquatic metabolism study as required by the Data Call

- In.

EPA Response: The referenced open

- literature laboratory study was investigated during the problem formulation phase by the Agency. Although EPA has not completed a formal review of this study, an official review will be conducted prior to the initiation of the regist ration

review risk assessment. DuPont should respond to the DCI with the option to cite an existing study . If this study is determined to be inadequate, the Agency w ould make the conservative assumption that bromacil is stable to microbial degradation in the risk assessment.5 PLANNED DATA NEEDS

The table below summarizes the planned data needs for bromacil based on the Registration Review: Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Bromacil and Bromacil Lithium salt (Case No. 0041)

, Bromacil; Human

- Health Assessment Scoping Document in Support of Registration Review

, Bromacil: Response to Comments on the Human

- Health Assessment Scoping Document and Preliminary Workp lan and Response to Comments Submitted to the Bromacil Registration Review Docket (Docket ID: EPA

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. The table has been updated since the PWP to reflect public comments that resulted in changes to the data needs

.

Planned D ata Needs for Bro macil’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism TGAI 24

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.2100 Avian acute oral toxicity 3 TGAI 12

850.4100 Seedling Emergence and Seedling Growth 4 TEP 12

850.4150 Vegetative Vigor 4 TEP 12

870.3465 90

- day inhalation toxicity TGAI 24

870.7800 Immunotoxicity TGAI 12
TGAI = technical grade active ingredient; TEP = typical end

- use product

3 Data are needed for the upland game species Bobwhite Quail

. 4 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00286 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of bromacil

. For human health, EPA

will conduct revised dietary and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are required for registration review

, they will be consid ered 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 planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document

. T he planned assessments have not changed

from what was included in the PWP

.

Planned Risk Assessments for Bromacil’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 bromacil’s reported ecological incidents, see page 66 of the Problem Formulation.

Human Health Dietary

Food Y Registered for the food crops citrus and pineapple. Drinking water Y The assessment will include available surface and groundwater monitoring data, taking into consideration any changes in use patterns that have

occurred. Occupational Handlers (m ixer s, loader s, applicators ) Y

Post

- application Y Required for citrus and pineapple.

Residential

Handlers N There are currently no registered uses of bromacil

and its lithium salts that would result in residential exposure. Therefore, a residential exposure assessment is not needed to support Registration

Review. Post

- application N

Other7 Aggregate Y E valuates the combined risk from dietary and residential exposures. As there are no registered uses that would result in residential exposure, the aggregate risk assessment will be equivalent to the dietary assessment.

Cumulative N Available data do not suggest that bromacil has a common mode/mechanism of toxicity with any other

chemical.

Tolerances Y The tolerance expression for bromacil will be
reviewed during registration review to ensure that it
appropriately covers the metabolites and degradates

of bromacil and that it specifies the residues to be
measured for each commodity.

Incident s Y For a discussion of bromacil’s reported human incidents, see page 14 of the Scoping Document.

TIMELINE

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

review

. The projected timeline has not changed since the PWP.

Registration Review for Bromacil

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period June 2012

– Completed

Close Public Comment August 2012

– Completed Case Development

Final Work Plan December 2012

– Completed

Issue DCI 2013

– July

– Sept.

Data Submission 2015

– July

– Sept.

30

- day Public Comment Period for Draft Risk Assessments 2017

– Jan.

– March Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2017

– July

– Sept.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 Total ( years ) 6

NEXT STEPS

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

and human health studies for bromacil through a data call

- in, expected to be issued in 2013

.