2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the A gency ) 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 pr event and control certain diseases associated with

rose plants ( e.g

. , black spot ( Diplocarpon rosoea ))

. The sole b romuconazole 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 stand ard 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 registere d 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 t he PWP was issued. Next is a summary of a ny substantive comment (s) received during the public comment period for the PWP

, and the Agency’s response to th at comment

. This section is followed by registration review planned data needs, risk assessments expe cted 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 (FEST F), 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 submitt ed by FESTF in EPA

- HQ

- OPP

- 2015

- 0535

- 0007

.

1 http://www2.epa.gov/pesticide

- reevaluation3 1. Comment: The FESTF comment indic ated 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, t he EPA has already completed a comprehensive ecological risk assessment, including a n 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 assessm ent 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 r equired for registration review

, they

will be considered in the new assessment

, as well as any changes to the standard operating

p rocedures or default exposure assumptions

.

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

Assessment and Scoping D ocument

. T he planned assessment (s) for bromuconazole have not changed from what was i dentified in the PWP

.4 Table 1 : Planned Risk Assessments for the Bromuconazole 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 es (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 Y es (Completed) For a discussion of reported ecological incidents for

b romuconazole see the Preliminary Ecological Risk Assessment for Registration Review for
Bromuconazole

, dated September 15, 2015 at www.regulations.gov in docket number EPA

- HQ

OPP

- 2015

- 0535

- 0004.

Human Health Dietary

Food N o A dietary assessment is not necessary for bromuconazole because there are no dietary exposures anticipated. Drinking water N o

Occupational Handlers (mixers, loaders, applicators) Y es The EPA intends to conduct a revised occupational handler and post

- application exposure and risk assessment during registration review. Post

- application Y es Residential

Handlers N o A residential assessment is not necessary for

bromuconazole because there are no residential exposures anticipated. Post

- application N o

Other Aggregate N o An aggregate assessment is not necessary for

bromuconazole because there are no residential, food or drinking water exposures anticipated.

Cumulative N o Bromuconazole is not a member of a cumulative

group. Tolerances N o There are no tolerances established for

bromuconazole.

Incidents Will check for

u pdates 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.5 Table 2: Registration Review for Bromuconazole

– Projected Registration Review

Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period for PWP, Scoping document and EFED Draft Risk

Assessment 2 September 2015

– Completed

Close Public Comment November 2015

– Completed Case Development

Final Work Plan February 2016

– Completed

6 0

- 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 bromuconaz ole preliminary human health

risk assessment for public comment in 2016

.

2 The regulations governing registration r eview 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.