2 

### Bromacil 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 9

Next Steps 9

Appendix

– Additional Areas Considered in Bromacil’s Registration Review 10

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 Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Bromacil and Bromacil Lithium salt (Case No. 0041)

. Baris, Miller

. May 22, 2012.

2. Bromacil; Human

- Health Assessment Scoping Document in Support of Registration

Review

. Levy, Rodriguez, Tyler, Van Alstine. May 9, 2012.

3. BEAD Chemical Profile for Registration Review: Bromacil (012301)

. Ratnayake, Alsadek, Ranville. December 5, 2011.

4. Bromacil: Review of Human Incidents

. Recore. February 29, 2012.

5. PRD Label Data Report: Food/Feed & Non

- Food/Non

- Feed Uses Considered in Registration Review Work Planning . November 23, 2011.

6. Bromacil (012301) Screening Level Usage Analysis (SLUA)

. August 9, 2011.

These and other supporting documents for the bromacil registration review case may be found in

the docket EPA

- HQ

- OPP

- 2012

- 0445 at http://www.regulations.gov

.3 OVERVIEW

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

- HQ

- OPP

- 2012

- 0445 )

. Both bromacil (PC Code: 012301) and bromacil lithium salt (PC Code: 012302) are incorporate d into the bromacil case. Bromacil is a broad spectrum herbicide registered for use to control weeds in the agricultural food crops citrus a nd pineapple. T he 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

. This Preliminary Work Plan (PWP) document explains what EPA's

Office of Pesticide Programs knows about bromacil

, 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 completi ng bromacil’s review

.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about bromacil and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on bromacil

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comm ents 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 specif ically 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 pestici des; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for bromacil

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides bromacil 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 egistratio n R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for bromacil . For additional discussion of the anticipated data needs, see 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) , May 22, 2012 and Bromacil; Human

Health Assessment Scoping Document in Su pport of Registration Review May 9, 2012

.

Anticipated Data Needs for Bromacil’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.1230 Adsorption/Desorption, Batch Equilibrium 1 TGAI 12

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 2 TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence, Tier

II TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor, Tier II TEP 12

870.3465 90

- day inhalation toxicity TGAI 24

870.6200 Neurotoxicity screening battery (acute and subchronic) TGAI 24 (12 each)

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

- use product ;

1 Guideline 835.1240 is not anticipated to be required for registration review as the additional data needed to fulfill this requirement (i.e. batch equilibrium data) are covered in this guideline.

2 Data are needed for either one waterfowl or one upland game species.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 envi ronment 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

s ure 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 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

. T he Agen cy 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 wha t 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 F ina l W ork P lan (FWP) and anticipated schedule for the registration review of bromacil.

BROMACIL CHEMICAL FACTS

PC code s 012301 and 012302

Case Number 0041

CAS Number s 314

- 40

- 9 and 53404

- 19

- 6

Year first registered 19 61 Pesticide Type herbicide

Chemical Class uracil

R eregistration Eligibility Decision (R E D) August 1996

Cumulative group NA

40 CFR Citation Permanent tolerances are established for residues of bromacil, including its metabolites and degradates (expressed as bromacil), in

and/or on food and /or feed commodities under 40 CFR §180.210

. Tolerances are established for residues of this herbicide on citrus and pineapple.

Dual

- use NA

Non

- pesticidal uses NA

3 http://www.epa.gov/oppsrrd1/registration_review/6 Pesticide Re

- evaluation Division, Chemical Review Manager Steven Snyderman, snyderman.steven@epa. gov , 703

- 347

- 0249

Registration Division

, Product Manager Kable (Bo) Davis, davis.kable@epa.gov

, 703

- 306

- 0415

Please see the BEAD Chemical Profile for Registration Review: Bromacil (012301) in the registration review docket for more details

. USE AND USAGE INFORMATION

Summary of Use Broad

- spectrum herbicide registered for use to control weeds in the agricultural food crops citrus and pinea pple and in a variety of non

agricultural uses.

Use Sites B oth bromacil and its lithium salt are registered for use to control weeds and brush in nonagricultural areas including ornamentals, forestry, rangeland, uncultivated agricultural areas, commercial, industrial and institutional maintenance, refuse storage areas, and rights

- of

- way for weed and brush control and as a total vegetation management tool. Only bromacil is registered for use as a soil

treatment on citrus and for post

- harvest application on pineapples. Summary of Usage From 2006

- 2010, the annual total agricultural usage of bromacil averaged approximately 370,000 pounds active ingredient for 260,000 treated acres. The use of bromacil in nurseries and greenhouse s was less than 500 lbs. a.i. in 2004. In 2006 use on turf farms was less than 500 lbs. a.i. and approximately 4,000 lbs. a.i. on landscape. Formulation Type(s) Emulsifiable concentrate, granular, liquid ready

- to

- use, pellets or tablets, pressu rized liquid, soluble concentrate, wettable powder,

and water

- dispersible granules. Application Method(s) Products can be applied by aerosol cans, aerial application

, groundboom, spreader

, handheld sprayers , sprinkler, granule applicator, and mechanical s prayers. Technical Registrant (s) E. I. Du Pont de Nemours and Company, Agan Chem Mfg, Ltd. No. of Registrations 54 Section 3 products 4 and 2 Section 24c registrations in Hawaii and Washington state.

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 e quipment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season ; geographic limitations on use

.

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).7 **•** U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

.

**•** M edian and 90 th

**•** A pplication timing (date of first application and application intervals)

– national, state, and county

. percentile reported use rates (lbs a

. i

. / acre ) from usage data

– national, state, and county

.

**•** Usage/use information for non

- agricultural uses /s ites

.

**•** Typical application interval (days)

.

**•** S tate or local use restrictions

.

**•** F oreign technical registrants not listed above who supply technical bromacil to the US

market

.

RECENT ACTIONS

There are no recent actions for the bromacil case

.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for bromacil was completed on January 29, 1996 in preparation for the Reregistration Eligibility Decision (RED)

. T he most recent ecological and environmental fate risk assessment was completed 1996 for the same

purpose . Findings and conclusions from these risk assessments are summarized in the Registration Review: Preliminary Problem Formulation for Environmental Fa te and Ecological Risk, Endangered Species, and Drinking Water Assessments for Bromacil and Bromacil Lithium salt (Case No. 0041) , May 22, 2012 and Bromacil; Human

- Health Assessment Scoping Document in Support of Registration Review , May 9, 2012

.

During r egistration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of bromacil

. For human health, EPA anticipates the need to conduct revised dietary and occu pational risk

assessment s during registration review

. If toxicological endpoints or points of departure are

revised based on the data that are anticipated to be required for registration review

, they will be

considered 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 anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

Anticipated Risk Assessments for Bromacil’s Registration Review

Type of Risk Assessment Incl ude? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Y8 Human Health Dietary

Food Y Registered for the food crops citrus and pineapple Drinking water Y Occupational Handlers (m ixer s, loader s, applicators ) Y

Post

- application Y

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

Incidental oral N Companion animal N

Recreational N

Other Aggregate Y E valuates the combined risk from dietary and residential exposures.

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

chemical.

Tolerances Y Tolerance expression update needed to reflect current Agency policy

.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

**•** Information on more sensitive endpoints that may be used in the risk assessment specifically information on ecological toxicity data for any species found to be more

sensitive than those outlined in the Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments for Bromacil and Bromacil Lithium salt (Case No. 0041) , May 22, 2012

**•** Use information that will refine analysis of areas planted with pineapple in the state of

Hawaii.

**•** Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

**•** Water quality m onitoring data collected since the 1996 RED (see Appendix for further details)

.9 TIMELINE

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

review

.

Registration Review for [insert pesticide]

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and Public Comment Period 2012

– June

Close Public Comment 2012

– August Case Development

Final Work Plan 2012

– November

Issue DCI 2013

– July

– Sept.

Data Submission 2015

– July

– Sept. Open Public Comment Period for Draft Risk Assessments 2017

– Jan.

– March

Close Public Comment Period 2017

– April

– June Registration Review Decision Open Public Comment Period for Proposed Registration Review

D ecision 2017

– July

– Sept.

Close Public C omment P eriod 2017

– Oct.

– Dec. Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 Total ( years ) 6

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 bromacil

.10 

### Appendix

– Additional Areas Considered in Bromacil’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 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 (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 M RLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding

the nature of the concern

.

Water Quality:

Bromacil is not identified as a cause of impairment for any water bodies listed as im paired under section 303(d) of the Clean Water Act 5

. In addition, n o Total Maximum Daily Load s (TMDL)

has been developed for bromacil 6 . More information on impaired water bodies and TMDLs can

be found at the Agency’s website 7

. The Agency invites submissi on 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 Re view 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 poli cies. 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 bromacil 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.htm11 ENDANGERED SPECIES :

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

conducted for bromacil

. The ecological risk assessment planned during registration review will allow the Agency to determine whether bromacil’s use has “no effect” or “may affect” federally

listed threatened or en dangered 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 bromacil , 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, repr oductive 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 reregistration decision for bromacil

, 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), bromacil 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 estr ogen, 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 ef fect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 6712 chemicals, which contains 58 pesticide active ingredients and 9 iner t ingredients. Bromacil 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, requiring the submission of EDSP screening assays for bromacil

. 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 website 9

.

HUMAN STUDIES :

Occupational

Past bromacil risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many differe nt pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Database

. EPA has reviewed all the studies supporting

these multi

- pesticide generic exposur e databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. A ll applicable r equirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued reliance on

these studies

.

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