2 

### Rotenone Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 5

Anticipated Risk Assessment s for Registration Review 6

Timeline 9

Next Steps 9

Appendix

– Additional Areas Considered in Rotenone ’s Registration Review 10

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. Registration Review : Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessment s for Rotenone

. Thomas Steeger, Cheryl Sutton

. September 8 , 2015.

2. Rotenone

. Human Health Assessment Scoping Document in Support of Registration

Review

. Bridgett Bobowiec, Sumitra Bose Biswas, Nancy McCarroll

. August 22 , 2015.

3. BEAD Chemical Profile for Registration Review: Rotenone ( 071003 ). Colwell Cook, Cynthia Doucoure, Elizabeth Hill . March 1 1 , 201 5

.

4. Rotenone : Tier I Review of Human Incidents . Elizabeth Evans, Shanna Recore. June 4

, 201 5

.

These and other supporting documents for the rotenone registration review case may be found in

the docket EPA

- HQ

- OPP

- 201 5

- 0 572 at http://www.regulations.gov

.3 OVERVIEW

The docket for Rotenone is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 201 5

- 0 572 )

. Rotenone is a naturally occurring compound present in

, and derived from the root of several plants . Rotenone is

formulated as a restricted use piscicide used to manage fish populations in lakes, ponds, reservoirs, rivers, and streams. There are no agricultural or residential uses for rotenone

. This Preliminary Work Plan (PWP) document summarizes wha t EPA's Office of Pesticide Programs

knows about rotenone

, identifies anticipated data and assessment needs, identifies the types of information that would be especially useful to the Agency in conducting the review , and provides an anticipated timeline fo r completing the rotenone registration review

.

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 rotenone and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on

rotenone

. The Agency encourages all interested stakeholders to review the PWP , it s Appendix

, and support documents 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, i nstitutional, residential, and other users of pesticides; or the public at large.

The P WP begins by listing the anticipated data needs for rotenone

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document pro vides

rotenone ’s 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 topics that a re considered generally in

R egistration R eview along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

The table below summarizes anticipated data need s for rotenone . For additional discussion of the anticipated data needs, see the Registration Review : Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Rotenone (9/8 /15 ) and Rotenone

. Human Health Assessment Scoping Document in Support of

Re gistration Review ( 8 / 22 /15 )

.

Anticipated Data Needs for Rotenone Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.1230 Adsorption/Desorption TGAI 24

8 35

. 2120 Hydrolysis TGAI 24

835.2370 Aqueous Photolysis TGAI 24

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.1010 Freshwater Invertebrate Acute Toxicity TEP 12

850.1025 Estuarine/Marine Mollusc Acute Toxicity TGAI 12

850.1075 Freshwater Fish Acute Toxicity

– Rainbow trout TEP 12

850.2300 Avian Reproduction

– waterfowl and upland game bird species TGAI 24

850.1735 Whole Sediment 10

- Day Freshwater Invertebrate TGAI 12

Non

Guideline Whole Sediment Chronic Freshwater and/or

Marine Invertebrate TGAI 2 4

TGAI = technical grade active ingredient TEP = typical end use product

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 envi ronment 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n on the registration review program is provided on EPA’s website 1

.

1 http://www.epa.gov/oppsrrd1/registration_review/5 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 by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket opening 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 Agenc y will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of rotenone

.

ROTENONE CHEMICAL FACTS

PC code 071003

Case Number 0255

CAS Number 83

- 79

- 4 Year first registered 1947 Pesticide Type Piscicide

Chemical class Isoflavone Reregistration Eligibility Decision (RED) Completed in 2007

Cumulative group NA

40 CFR Citation An exemption from tolerances was granted for rotenone, and the exemptions is currently listed under 40 CFR § 180.905.

Non

- pesticidal uses NA

Pesticide Re

- evaluation Division, Chemical Review Manager Kelly Ballard, ballard.kelly@epa.gov

, (703) 305

- 8126

Registration Division, Product Manager Mark Suarez

, suar ez.mark@epa.gov , (703) 30 6

- 0415

USE AND USAGE INFORMATION FOR ROTENONE

Please see the BEAD Chemical Profile for Registration Review: Rotenone ( 071003 ) in the registration review docket for more details

.

Type of Pesticide Rotenone is a restricted use piscicide

. Use Sites There are no agricultural use sites for rote n one.

Non

- agricultural use sites for rotenone are aquatic areas, including lakes, ponds, reservoirs, rivers, streams, and in aquaculture. Summary of Usage EPA has limited data from other f ederal and state government agencies indicating small amount s of usage of rotenone. Formulation Types Dust, liquid, emulsifiable concentrate, and wettable powder

.6 Application Methods Rotenone is applied with aircraft, backpack sprayer, drip can, or

handheld or hand

- directed nozzle to the water surface

. Technical Registrant s There are no technical registrants * . However, there are three registrants with manufacturing formulation products: Central Garden & Pet Company, Foreign Domestic Chemical Corp, and

TIFA International LLC.

Number of Registrations Twelve Section 3 products and two Section 24 (c) product s 2

. There is also an Experimental Use Permit.

Restricted Use Yes
*Please note: There are no technical registrants , only formulating registrants

, due to the compound not being synthesized but rather extracted and then formulated into the product.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive ecological risk assessment for rotenone was completed in 2006 in support of the RED. The most r ecent comprehensive human health risk assessment w as also completed in 200 6 in support of the RED. Findings and conclusions from these risk assessments

are summarized in the Registration Review : Preliminary Problem F ormulation for Ecological

Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for

Rotenone ( 9 / 8 /1 5) and Rotenone. Human Health Assessment Scoping Document in Support of Registration Review ( 8 / 22 /15 )

.

During registration review , t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of rotenone

. For human health, EPA anticipates the need to conduct revised dietary (drinking water only), residential post

- application

, and occupational risk assessments during registration review.

The table below summarizes the anticipated registration review risk assessments based on the

Problem Formulation and Scoping Document

.

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 Anticipated Risk Assessment s for Rotenone Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological

risk assessment

, including endangered species Y

Ecological Incidents Will check for updates For a discussion of reported e cological incidents for

rotenone , see page 12 of the Problem Formulation.

Human Health Dietary

Food N There are no food uses registered for rotenone; therefore a dietary exposure assessment for food in not required. Drinking water Y The Agency anticipates updating the drinking water analysis for rotenone, and so an updated dietary assessment for water only is anticipated for registration

review

. Occupational Handlers (mixers, loaders, applicators) Y An updated quantitative occupational handler exposure

assessment for all formulations and application

scenarios is needed for r egistration r eview.

Post

- application N It is unlikely that workers will come in contact with previously rotenone

- treated water and any pos t

application exposure is likely less than exposure to handlers and applicators. T herefore a quantitative occupational post

- application exposure assessment is

not anticipated for r egistration r eview.

Residential

Handlers N There are no proposed or current residential uses for rotenone; therefore a quantitative residential handler exposure assessment is not anticipated for r egistration

r eview.

Post

- application Y The Agency anticipates updating its residential post

applicatio n swimming analysis (for possible exposure to those who may swim in rotenone

- treated waters).

The need for a spray drift and volatilization assessment may be considered for r egistration r eview.

Other Aggregate Y An updated aggregate assessment may incorporate updated dietary (drinking water only) and updated residential post

- application exposures.

Cumulative N The Agency has not determined whether rotenone shares a common mechanism of toxicity with other

chemical substances.8 Tolerances N As per 40 CFR §180. 905 , rotenone is exempt from the requirement of a tolerance on all food commodities.

Human Health Incidents Will check for updates For a discussion of reported human health incidents for

rotenone, see pages 8

- 9 of the Scoping Document and

the Rotenone : Tier I Review of Human Incidents

document.

Guidance for Commenters: Additional areas of use and usage related information and ecological information requested for this registration review, and of particular interest to EPA, is 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 ; and geogr aphic limitations on use

.

• U se distribution ( e.g. , g eographical distribution of relevant use sites )

.

• M edian and 90 th percentile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

.

• Typical a pplication information

– national, state, and county

.

• Usage/use information

.

• Typical application interval (days).

• S tate or local use restrictions

.

• Foreign technical registrants not listed above who supply technical rotenone to the US market (if applicable).

• Ec ological incidents (non

- target plant d amage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring data (see Appendix for further details).

TIMELINE

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

review

.

Registration Review for Rotenone

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Comment Period 201 5

– September

Close Public Comment 201 5

– November

Case Development

Final Work Plan 201 6

– February

Issue DCI 201 6

– April

– June

Data Submission 201 8

– April

– June9 Registration Review for Rotenone

– Projected Registration Review Timeline

Activities Estimated Date

60

- Day Public Comment Period for Draft Risk Assessments 3 201 9

– October

– December Registration Review Decision

60

- Day Public Comment Period for Proposed Registration Review

Decision 20 20

– July

– August Registration Review Decision and Begin Post

- Decision Follow

- up 20 2 1 Total (years) 6

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 Final Work Plan for the registration

review of rotenone

.

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 con ventional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.10 

### Appendix

– Additional Topics Considered in the Rotenone Re gistration

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:

Rotenone 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)

ha s been developed for rotenone 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, submissions should include the key data elements noted in

the OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data 7 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 rotenone compared to the general population. Please comment if you are aware of any sub

- po pulations that may have atypical, unusually high exposure compared to the general population.

ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determination has not been

conducted for rotenone

. The ecological risk assess ment planned during registration review will allow the Agency to determine whether rotenone ’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.

4 http://iaspub.ep a.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5 http://iaspub.epa.gov/tmdl_wat ers10/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.htm11 ENDOCRINE DISRUPTO R 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 carcin ogenicity, 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 cycl icity, 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 re

- registration decision for rotenone

, EPA reviewed these data

and se lected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), rotenone is subject to the endocrine screening part of the Endocrine Disr uptor Screening Program (E DSP).

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 estr ogen, 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 ef fect.

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 iner t 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 kn own 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

8 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 f or the final second list of

chemicals.

9 http://www.epa.gov/endo/12 HUMAN STUDIES :

Occupational and Residential

Past rotenone 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 Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database , and the Outdoor Residential Exposure Task Force (ORETF) Datab ase

. 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. A ll applicable requirements 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

.