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INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of bromuconazole. This work plan addresses the one public comment

received concerning the Preliminary Work Plan (PWP), which was posted in the bromuconazole

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

registered for use on greenhouse roses to prevent and control certain diseases associated with

rose plants (e.g., black spot (Diplocarpon rosoea)). The sole bromuconazole end-use product is 

formulated as an emulsifiable concentrate. 

The EPA 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 when the initial docket is opened for each case. Information 

on this program is provided on the Agency’s website.

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The FWP begins with any updates since the PWP was issued. Next is a summary of any

substantive comment(s) received during the public comment period for the PWP, and the 

Agency’s response to that comment. This section is followed by registration review planned 

data needs, risk assessments expected to be conducted, and the projected registration review 

timeline for bromuconazole. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no updates on bromuconazole since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the bromuconazole PWP, which opened on 

October 2, 2015 and closed on December 1, 2015, the Agency received one public comment. 

The comment was submitted by the FIFRA Endangered Species Task Force (FESTF), and did 

not affect the anticipated registration review data needs, risk assessments, or timeline. 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 issues.

This section contains a summary of the FESTF comment received and the EPA’s response. The 

full FESTF comment is located in the docket, EPA-HQ-OPP-2015-0535, accessible at 

www.regulations.gov. 

Comments submitted by FESTF in EPA-HQ-OPP-2015-0535-0007.

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1. Comment: The FESTF comment indicated that the technical registrant of bromuconazole 

(Valent USA Corporation) is a current member of FESTF, and as such, is entitled to the FESTF 

data on federally-listed threatened and endangered species. 

Response: The Agency thanks FESTF for their comment and will consider the appropriate 

information at the time of the endangered species assessment. 

PLANNED DATA NEEDS

No data needs were identified to assess bromuconazole during the registration review process.

RISK ASSESSMENTS FOR REGISTRATION REVIEW

As part of the initiation of this registration review for bromuconazole, the EPA has already 

completed a comprehensive ecological risk assessment, including an endangered species 

assessment for bromuconazole’s single use on greenhouse roses. Based upon these assessments, 

at this time, the EPA does not anticipate conducting a new full ecological risk assessment for 

bromuconazole for registration review. For human health, the EPA will conduct a revised 

occupational handler and post-application exposure risk assessment. If toxicological endpoints 

or points of departure are revised based on the data that are required for registration review, they 

will be considered in the new assessment, as well as any changes to the standard operating 

procedures or default exposure assumptions.

Table 1 below summarizes the planned risk assessment based on the Problem Formulation/Risk 

Assessment and Scoping Document. The planned assessment(s) for bromuconazole have not 

changed from what was identified in the PWP.
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Table 1: Planned 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 quantitative 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

(Completed)

For a discussion of reported ecological incidents for 

bromuconazole see the Preliminary Ecological Risk 

Assessment for Registration Review for 

Bromuconazole, dated September 15, 2015 at 

www.regulations.gov in docket number EPA-HQOPP-2015-0535-0004.

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.

TIMELINE

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

registration review in Table 2 below. The projected timeline has not changed since the PWP. 
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Table 2: Registration Review for Bromuconazole – Projected 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 

Assessment2

September 2015 – Completed 

Close Public Comment November 2015 – Completed 

Case Development

Final Work Plan February 2016 – Completed 

60-day Public Comment Period for Draft HED Risk 

Assessment

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

As noted previously, the Agency plans to publish a bromuconazole preliminary human health

risk assessment for public comment in 2016.

 2 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.