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Bromuconazole Preliminary Work Plan – Table of Contents

OVERVIEW ................................................................................................................................... 3

ANTICIPATED DATA NEEDS .................................................................................................... 3

STATUTORY AND REGULATORY AUTHORITY................................................................... 4

CHEMICAL FACTS ...................................................................................................................... 4

USE AND USAGE INFORMATION............................................................................................ 5

RECENT ACTIONS....................................................................................................................... 6

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 6

TIMELINE...................................................................................................................................... 8

NEXT STEPS ................................................................................................................................. 8

Appendix – Additional Areas Considered in the Bromuconazole Registration Review............ 9

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Preliminary Ecological Risk Assessment for Registration Review for Bromuconazole (PC 

Code: 120503; DP Barcode: D427264). José L. Meléndez and Geoffrey Sinclair, Ph.D.,

September 15, 2015.

2. Bromuconazole. Human Health Scoping Document in Support of Registration Review. 

Barry O’Keefe and Vincent Chen, July 20, 2015.

3. Bromuconazole: Tier 1 (Scoping) Review of Human Incidents. Shanna Recore and 

Elizabeth Evans, July 20, 2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Bromuconazole (120503). Carl 

Chen, Rafael Prieto, and Stephen Smearman, March 31, 2015.

These and other supporting documents for the bromuconazole registration review case may be 

found in the docket EPA-HQ-OPP-2015-0535 at http://www.regulations.gov.
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OVERVIEW

The docket for bromuconazole is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0535). Bromuconazole is a fungicide 

which is formulated as an emulsifiable concentrate and is solely registered for use on greenhouse 

roses to control black spot. This Preliminary Work Plan (PWP) document explains what EPA's 

Office of Pesticide Programs knows about bromuconazole, 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 the 

registration review for bromuconazole.

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 bromuconazole and what types of new data 

or other information would be helpful for the Agency to receive as it moves toward a decision on 

bromuconazole. 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 

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 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.

This PWP does not list any anticipated data needs and announces the availability of the

ecological and fate risk assessment (which includes a screening level endangered species 

assessment (ESA)) for bromuconazole. It also discusses the statutory and regulatory authority for 

Registration Review. The PWP also provides chemical facts, use and usage information, recent 

actions, the anticipated risk assessments, and a projected registration review timeline for 

bromuconazole. Finally, the Appendix to this document includes identification and discussion of 

some areas that are generally considered in Registration Review along with some additional 

chemical case-specific information.

ANTICIPATED DATA NEEDS

There are no anticipated data needs for bromuconazole. For additional discussion of the

available data, see the Preliminary Ecological Risk Assessment for Registration Review for 

Bromuconazole (PC Code: 120503; DP Barcode: D427264) and the Bromuconazole. Human 

Health Scoping Document in Support of Registration Review, available in the public docket 

EPA-HQ-OPP-2015-0535, which can be accessed on http://www.regulations.gov/. 
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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 website.

1

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 for the PWP, HED Scoping, and EFED Preliminary Risk Assessment (PRA), 

the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration 

review of bromuconazole.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for bromuconazole.

Table 2: Chemical Facts for Bromuconazole

PC code 120503

Case Number 7035

CAS Number 116255-48-2

Year first registered September 30, 2002

Pesticide Type Fungicide

 1 http://www.epa.gov/oppsrrd1/registration_review/
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Table 2: Chemical Facts for Bromuconazole

Chemical class Triazole

Reregistration Eligibility 

Decision (RED)

Not applicable. Bromuconazole was registered after November 

1984 and therefore was not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable. There are no established tolerances for 

bromuconazole.

Cumulative group Not applicable. Bromuconazole has not been identified as a 

member of a cumulative group that shares a common mechanism 

of toxicity.

40 CFR Citation There are no established tolerances for bromuconazole.

Dual-use Bromuconazole is registered for conventional pesticidal uses only 

and has no registered antimicrobial or biopesticidal uses.

Non-pesticidal uses There are no identified non-pesticidal uses of bromuconazole.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Name: James Parker

Email: parker.james@epa.gov

Phone: (703) 306-0469

Registration Division, 

Product Manager

Name: Hope Johnson

Email: johnson.hope@epa.gov

Phone: 703-305-5410

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for bromuconazole. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Bromuconazole (120503) dated March 31, 

2015 in the registration review docket for more details.

Table 3: Bromuconazole Use and Usage Information

Summary of Use Bromuconazole is a foliar fungicide registered only for use on 

greenhouse roses to prevent and control certain diseases of roses 

(e.g. black spot (Diplocarpon rosoea)).

Summary of Usage Bromuconazole was registered on September 30, 2002. However,

quantitative information on bromuconazole usage is not available.

Formulation Type(s) Bromuconazole has one end-use product which is formulated as 

an emulsifiable concentrate. 
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Table 3: Bromuconazole Use and Usage Information

Application Method(s) Bromuconazole is applied by handheld sprayers.

Technical Registrant(s) The sole technical registrant is Valent U.S.A. Corporation.

Number of Registrations Bromuconazole has 2 Section 3 products2.

Restricted Use Bromuconazole is not a restricted use pesticide.

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.

• Use distribution (e.g., geographical distribution).

• Typical application timing information– national, state, and county.

• Foreign technical registrants not listed above who supply technical bromuconazole to the 

US market.

RECENT ACTIONS

There are no recent actions for bromuconazole.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for bromuconazole was completed 

in 2002 when bromuconazole was initially registered by EPA. No ecological and environmental 

fate risk assessment was developed for bromuconazole at the time of the initial registration 

because of bromuconazole’s use pattern. Therefore, the current ecological and environmental 

fate risk assessment that has been completed for this registration review is also the most recent 

assessment. Findings and conclusions associated with bromuconazole can be found in both the

Preliminary Ecological Risk Assessment for Registration Review for Bromuconazole (PC Code: 

120503; DP Barcode: D427264) and the Bromuconazole. Human Health Scoping Document in 

Support of Registration Review.

The Agency has already completed a comprehensive ecological risk assessment for registration 

review, including a screening level endangered species assessment (for bromuconazole’s use on 

greenhouse roses). For human health, EPA anticipates the need to conduct a revised 

occupational handler and post-application exposure risk assessment during registration review.

If toxicological endpoints or points of departure are revised, they will be considered in the new 

 2 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

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

assessments, as well as any changes to the standard operating procedures or default exposure 

assumptions.

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Risk Assessment and HED Scoping Document.

Table 4: Anticipated Risk Assessments for the Bromuconazole 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 

Yes,

Completed

A comprehensive risk assessment and screening 

level endangered species assessment has been 

completed and made available for public comment 

in the bromuconazole registration review docket.

Incidents Yes For a discussion of reported ecological incidents

for bromuconazole see the Preliminary Ecological 

Risk Assessment for Registration Review for 

Bromuconazole, dated September 15, 2015

Human Health

Dietary

Food No A dietary assessment is not necessary for 

bromuconazole because there are no dietary 

exposures anticipated.

Drinking water No

Occupational

Handlers (mixers, loaders, 

applicators)

Yes The EPA intends to conduct a revised occupational 

handler and post-application exposure and risk 

Post-application Yes assessment during registration review.

Residential

Handlers No A residential assessment is not necessary for 

bromuconazole because there are no residential 

exposures anticipated.

Post-application No

Other

Aggregate No An aggregate assessment is not necessary for 

bromuconazole because there are no residential, 

food or drinking water exposures anticipated.

Cumulative No Bromuconazole is not a member of a cumulative 

group.

Tolerances No There are no tolerances established for 

bromuconazole.

Incidents Will check for 

updates

For a discussion of reported human incidents for 

bromuconazole, see the Bromuconazole: Tier 1 

(Scoping) Review of Human Incidents dated July 

20, 2015.
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TIMELINE

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

registration review in Table 5 below.

Table 5: Projected Bromuconazole Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period for 

PWP, Scoping document and EFED Draft Risk 

Assessment3

2015 – September

Close Public Comment 2015 – November

Case Development

Final Work Plan 2016 – February

60-day Public Comment Period for Draft HED Risk 

Assessment3

2016 Oct. – Dec.

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2017 Jul. – Sept.

Registration Review Decision and Begin Post-Decision 

Follow-up

2018

Total (years) 3

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 bromuconazole.

 3 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.
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Appendix – Additional Areas Considered in the Bromuconazole 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.

Water Quality:

Bromuconazole is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.

4

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for bromuconazole.

5

 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.

6 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 Process7 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 bromuconazole 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.

ENDANGERED SPECIES:

The EPA has conducted a screening level endangered species assessment for bromuconazole in 

its recent registration review ecological and environmental fate assessment. See “Preliminary 

Ecological Risk Assessment for Registration Review for Bromuconazole (PC Code: 120503; DP 

Barcode: D427264)” dated September 15, 2015 for more discussion regarding the screening 

level ESA for bromuconazole. 

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

 4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 5

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES 6 http://www.epa.gov/owow/tmdl/

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
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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 most recent registration decision for bromuconazole 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), 

bromuconazole 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 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 20138 and includes some 

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. 

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.9

HUMAN STUDIES:

Occupational

 8 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 9 http://www.epa.gov/endo/
11

Past bromuconazole 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.