2 

### Bromuconazole Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 3

STA TUTORY AND REGULATORY AUTHORITY

................................ ................................ ... 4

CHEMICAL FACTS

................................ ................................ ................................ ...................... 4

USE AND USAGE INFORMATION

................................ ................................ ............................ 5

RECENT ACTIONS

................................ ................................ ................................ ....................... 6

ANTICIPATED R ISK 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 summarize s 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 Suppor t 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 ht tp://www.regulations.gov

.3 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

, h ighlighting 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, b y sharing this information in the docket, to inform the public of what it knows about bromuconaz ole 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 Appen dix 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, reside ntial, 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

. I t also discusses the statutory and regulatory authority for

R egistration R eview. The PWP also provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review t imeline for

bromuconazole

. Finally, the Appendix to this document includes identification and discussion of some areas that are generally considered in R egistration R eview along with some additional

chemical case

- specific information.

ANTICIPATED DATA NE EDS

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/

.4 STATUTORY AND REGULAT ORY 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), b ased 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 marketpla ce can be used safely. Informatio n 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

. T he Agency will consider benefits information and data as required b y 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 believ es 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 devel op a F inal W ork P lan (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/5 Table 2: Chemical Facts for Bromuconazole

Chemical class Triazole

R eregistration Eligibility Decision (R E D) 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 cumulat ive 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) 3 06

- 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.6 Table 3 : Bromuconazole Use and Usage Information

Application Method(s) Bromuconazole is applied by handheld sprayers

.

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

.

Number of Registrations Bromuconazole has 2 Section 3 products 2

.

Restricted Use Bromuconazole is not a restricted use pesticide.

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 equip ment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season

.

• U se distribution ( e.g. , geographical distribution)

.

• Typical a pplication timing information

– national, state, and county

.

• F oreign 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 environm ental

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 associ ated 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

.

T he 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 Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).7 assessment s
, as well as any changes to the standard operating procedures or default exposure assumptions.

T able 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

Eco logical 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 ecologi cal 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 intend s to conduct a revised occupational handler and post

- application exposure and risk assessment during registration review. Post

- application Yes

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

.8 TIMELINE

EPA has created the follow ing estimated timeline for the completion of the bromuconazole registration review in Table 5 below

.

Table 5: Projected Bromuconazole Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

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

Assessment 3 2015

– September

Close Public Comment 2015

– November Case Development

Final Work Plan 2016

– February

6 0

- day Public Comment Period for Draft HED Risk

Assessment 3 201 6 Oct.

– Dec

.

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 20 1 7 Jul

. – Sept.

Registration Review Decision and Begin Post

- Decision

Follow

- up 20 1 8

Total (years) 3

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 f inal w ork p lan for the registration

review of bromuconazole

.

3 The regulations governing Registration Review generally require the A gency 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

A gency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.9 

### Appendix

– Additional Areas Considered in the Bromuconazole 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.

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, n o Total Maximum Daily Load s (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 Process 7 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Envi ronmental 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 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 con ducted a screening level enda ngered 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_303 d?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_r eview/water_quality_sop.htm10 As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemi cals. 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 suscepti ble 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 differen t 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 devel oped 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 Admin istrator 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, androge n, 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, 2013 8 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 pestic ides, 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 exposure databas es, 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 requiremen ts 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

.