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 Assessments for Registration Review 7

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in Bromacil’s Registration Review 10

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 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 incorporated into the bromacil case. 

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. 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 completing 

bromacil’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 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 comments and additional information that will help the Agency’s decisionmaking 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 bromacil. Next, it 

discusses the statutory and regulatory authority for Registration Review. 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 

Registration Review 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; HumanHealth Assessment Scoping Document in Support 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 Equilibrium1 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 toxicity2 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 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 bromacil.

BROMACIL CHEMICAL FACTS

PC codes 012301 and 012302

Case Number 0041

CAS Numbers 314-40-9 and 53404-19-6

Year first registered 1961

Pesticide Type herbicide

Chemical Class uracil

Reregistration Eligibility 

Decision (RED)

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 pineapple and in a variety of nonagricultural uses.

Use Sites Both 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 

greenhouses 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, pressurized 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 sprayers.

Technical Registrant(s) E. I. Du Pont de Nemours and Company, Agan Chem Mfg, Ltd.

No. of Registrations 54 Section 3 products4 and 2 Section 24c registrations in Hawaii 

and Washington state.

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 

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 Product Label System (PPLS) website 

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

• Use distribution (e.g., acreage and geographical distribution of relevant use sites).

• Median and 90th

• Application 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/sites.

• Typical application interval (days).

• State or local use restrictions.

• Foreign 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). The 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 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 Support of Registration Review, May 9, 2012.

During registration review, the 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 occupational risk 

assessments 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 assessments, as well as any changes to the standard operating procedures 

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 Include? Notes

Ecological and Environmental Fate

Comprehensive ecological 

(species to be assessed include 

terrestrial and aquatic 

organisms), including 

endangered species 

Y 
8

Human Health

Dietary

Food Y Registered for the food crops citrus and pineapple

Drinking water Y

Occupational

Handlers (mixers, loaders, 

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 Evaluates the combined risk from dietary and 

residential exposures.

Cumulative N Available data do 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 Commenters: Additional ecological information requested for this 

registration review, 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.

• Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency.

• Water quality monitoring data collected since the 1996 RED (see Appendix for further 

details).
9

TIMELINE

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

review.

Registration Review for [insert pesticide] – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

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 

Decision

2017 – July – Sept.

Close Public Comment Period 2017 – Oct. – Dec.

Registration Review Decision and Begin Post-Decision Follow-up 2018

Total (years) 6

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 bromacil.
10

Appendix – Additional Areas Considered in Bromacil’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.

Water Quality:

Bromacil 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) 

has been developed for bromacil6

. 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 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_

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

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
11

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered 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 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 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, 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 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 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 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 
12

chemicals, which contains 58 pesticide active ingredients and 9 inert 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 callins, 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 website9.

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 different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the 

Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting 

these multi-pesticide generic exposure 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. All 

applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 

CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies.

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