2 

### Flumetralin Prel iminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

................................ ................................ ............................ 7

RECENT ACTIONS

................................ ................................ ................................ ....................... 8

ANTICIPATED R ISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ 8

TIMELINE

................................ ................................ ................................ ................................ .... 13

NEXT STEPS

................................ ................................ ................................ ............................... 13

Appendix

– Additional Areas Considered i n the Flumetralin Regist ration Review

................. 14

References:

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

1. Problem Formula tion for the Environmental Fate and Ecological Risk in Support of the Registration Review of Flumetralin

. Kiernan, B.; Ibrahim, A. December 9, 2015

.

2. Flumetralin . Human Health Risk Assessment for Registration Review

. Bever, R.; Taylor, L.; Lloyd, M. December 15 , 2015

.

3. Flumetralin : Tier 1 (Scoping) Review of Human Incidents/Epidemiology . Recore , S; Evans, E. October 22, 2015

.

4. BEAD Chemical Profile (BCP) for Registra tion Review: Flumetralin (123001 )

. Yourman, L.; Paisley

- Jones, C

. June 17, 2015

.

5. Flumetralin (123001 ) Screening Level Usage Analysis ( SLUA )

. January 8, 2015.3 6. Flumetralin (123001 ) EFED Table 1 Report

. February 19, 2015

.

7. Flumetralin (123001 ) HED Master Label Report. February 19, 2015

.

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

in the docket EPA

- HQ

- OPP

- 2015

- 0076 a t http://www.regulations.gov

.4 OVERVIEW

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

- HQ

- OPP

- 2 015

- 00 76 )

. F lumetralin is registered for conventional pesticide use as a plant growth regulator to control axillary bud growth (suckers) on certain types of tobacco plants

. This Preliminary Work Plan (PWP) document explains what

EPA's Office of Pesticide Programs knows about flumetralin

, 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 regi stration review for flumetralin

.

This PWP also includes a summary of the draft human health risk assessment for flum etralin’s registration review. The last comprehensive human health risk assessment for flumetralin was completed in support of the 2007 Rer egistrati on Eligibility Decision (RED). Only minor updates

to the RED human health risk assessment were required to meet current risk assessment standards, so EPA developed a combined scoping document and draft human health ri sk

assessment for flumetralin. The last ecological risk assessment for flumetralin was also completed to support the RED. The ecological risk assessment and data needs for flumetralin’s registration review are discussed in the Problem Formula tion for the Environmental Fate and Ecologic al Risk in Support of the Registration Review of Flumetralin

. T his document does not

include the draft eco logical risk assessment, as it cannot be conducted until the data needs are

addressed. The draft risk human health risk assessment document and ecolog ical problem

formulation are posted in the docket, along with the flumetralin PWP and other supporting documents, for a 60

- day public comment period.

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

. 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

mak ing process for this chemical. In addition t o general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically s eeks comments and information. Interested stakeholders could include:

environmental non

- profit or interest g roups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the a nticipated data needs for flumetralin

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, conclusions of the draft

human health risk assessment , an overview of the planned ecol ogical risk assessments, and a projected registration review timeline for flumetralin

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

R eview along with some addition al chemical case

- specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summar izes a nticipated data needs for flumetralin

. For additional discussion of the anticipated data needs, see the document titled Problem Formula tion for the Environmental

Fate and Ecological Risk in Support of the Registration Review of Flumetralin and the document

titled Flumetralin . Human Health Risk Assessment for Registration Review

.

Table 1: Anticipated Data Needs for the Flumetralin Registration Review

Guideline

N umber 1 Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

835.2240 Aquatic photolysis TGAI 12

835.2410 Soil photolysis TGAI 12

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic aquatic metabolism TGAI 24

835.6100 Terrestrial field dissipation study TGAI 24

850.6100 Enforcement Analytical Method (ECM) and corresponding Independent Laboratory V alidat ion (ILV) report for soil TGAI 12

850.6100 Enforcement Analytical Method (ECM) and corresponding Independent Laboratory Validation (ILV) report for water TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.450 0 Aquatic non

- vascular plant toxicity 2 TGAI 12

850.4550 Aquatic non

- vascular plant toxicity 2 TGAI 12

Non

- GDLN (OECD 213) Tier I honeybee adult acute oral toxicity TGAI 12

Non

- GDLN Tier I honeybee adult chronic oral toxicity TGAI 12

Non

- GDLN
(OECD 237) Tier I honeybee larval acute oral toxicity TGAI 12

Non

- GDLN Tier I honeybee larval chronic oral toxicity TGAI 12

Non

- GDLN Tier II field trial of residue s in pollen and nectar 3 TEP 24

Non

- GDLN
(OECD 75) Tier II semi

- field testing for honeybee toxicity (tunnel/enclosure or colony feeding) 3 TEP 24

1 On June 27, 2012, EPA announced certain revisions in harmonized guideli ne series 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 While data on green algae are used provisionally in the EFED Problem Formulation, the underlying study has not

been reviewed by EPA. Further, studies using three other taxa of aquatic nonvascular species are necessary to complete a risk assessment.

3 The need for theses anticipated data requirements is contingent on results of the tier 1 bee studies (including acute

or al toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, and chronic oral toxicity to larval honey bees)

.6 Table 1: Anticipated Data Needs for the Flumetralin Registration Review

Guideline

N umber 1 Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

850.3040 Tier III field testing for pollinator toxicity 3 TEP 24

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 environment when used as directed on product labeling. The registra tion 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

envir onment. 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. Informatio n on this program is provided on EPA’s website

. 4

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 is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses

and data or infor mation 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 Agency will develop a F inal W ork P lan (FWP) and anticipated schedule fo r the registration review of flumetralin

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for flumetralin

.

Ta ble 2: Chemical Facts for Flumetralin

PC code 123001

Case Number 4119

CAS Number 62924

- 70

- 3

Year first registered 1983 Pesticide Type Plant growth regulator

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

- reevaluation7 Ta ble 2: Chemical Facts for Flumetralin

Chemical class 2,6

- Dinitroaniline

R eregistration Eligibility Decision (R E D) 2007

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicabl e; f lumetralin has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation N ot applicable; n o tolerances are required to support the use of

flumetralin on tobacco.

Dual

- use Not applicable; flumetralin is registered for conve ntional pesticidal uses only.

Non

- pesticidal uses There are no identifi ed non

- pesticidal uses of flu m e tralin

. Pesticide Re

- evaluation Division, Chemical Review Manager Katherine St. Clair, stclair.katherine@epa.gov , 703

- 347

- 8778

Registration Division

, Product Manager Tony Kish

, kish.tony@epa.gov, 703

- 308

- 9443

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for flumetralin

. Please see the BEAD Chemical Profile ( BCP) for Regis tration Review: Flumetralin (123001 ) in the registration review

docket for more details

.

Table 3 : Flumetralin Us e and Usage Information

Summary of Use F lumetralin is registered for conventional pesticide use as a plant growth regulator to control axillary bud growth (suckers) on certain types of tobacco plants.

Flumetralin is applied only once or twice per growing season. As a sucker control chemical, flumetralin is applied after the floral portion s of tobac co plants have topped , usually within two days of topping . Flumetralin is absorbed by the plant within a few hours of application and provides residual control throughout the

remainder of the growing season.

There are no registered residential uses.

Use Sites Agricultural Use Sites Flumetralin is registered for use on t obacco only. It is not registered for use on any other agricultural crops.

Non

- Agricultural Use Sites Flumetralin is not registered for any non

- agricultural uses.8 Table 3 : Flumetralin Us e and Usage Information

Summary of Usage I n the period from 2009 to 2013, approximately 103,000 pounds of flumetralin were applied over 170,000 acres annually , treating an average of 50 percent of tobacco crops

. Formulation Type(s) Flumetralin end use products are formulated as emulsifiable

concentrat e s

. Application Method(s) Flumetralin products can be applied by hand or by ground sprayer equipment. Technical Registrant (s) Flumetralin technical registrants include Drexel Chemical Company, MacDermid Agricultural Solutions, and Syngenta.

No. of Registrations As of December 2015, there are seven Section 3 registrations, 5

incl uding three technical products and four end

- use products

. Restricted Use Flumetralin i s not c lassified as 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 equipm ent ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

• Percent of applied flumetralin that is absorbed by tobacco plants.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• Typical application interval (days)

.

• F oreign technical registrants not listed above who supply te chnical flumetralin to the US

market

.

RECENT ACTIONS

There are no recent or pen ding actions. The RED f or flumetralin was signed in September 2007

, and the product reregistration process has been completed.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health and ecological ris k assessment s for flumetralin were completed in support of the 200 7 Reregistra tion Eligibility Decision (RED) , and an updated human health risk assessment was completed in December 2015 for the flumetralin registration review docket opening . F indings and c onclusions from these risk assessments are summarized in

the document titled Problem Formula tion for the Environmental Fate and Ecological Risk in Support of the Registration Review of Flumetralin and the document titled Flumetralin . Human

Health Risk Assessment for Registration Review

.

5 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).9 During registration review, EPA anticipates the need to conduct a comprehensive ecological risk assessment, including a pollinator risk assessment and a n endange red species assessment

, for the

use of flumetralin as a plant grown regulator on tobacco crops

.

EPA anticipates requiring data to support the p lanned risk assessments. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in the anticipated ecological risk assessment or in

a revised human health risk assessment

, as will any changes to the standard operating p rocedures or default exposure assumptions

.

Table 4 summarizes the recently completed regist ration review human health draft risk assessment and the planned ecological risk assessments as detailed in the document titled

Problem Formula tion for the Environmental Fate and Ecological Risk in Support of the Registration Review of Flumetralin and the document titled Flumetralin . Human Health Risk Assessment for Registration Review

.

Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Flumetralin Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Yes

– to be

conducted EPA anticipates conducting an updated comprehensive ecological risk assessment during registration review. The new assessment will incorporate the most up

- to

- date modeling methodologies, updated toxicological endpoints, and data submitted under the anticipate d registration

review data call

- in.

Incidents Will check for updates For a discussion of reported ecological incidents for

flumetralin , see Section 4.3 of t he document titled

Problem Formula tion for the Environmental Fate and Ecological Risk in Support of the Registration Review of Flumetralin

. Human Health Dietary Dietary Yes

- completed The registration review human health risk assessment did not identify any dietary (drinking water) risks of

concern. For the highest exposed population subgroup, females 13

- 49 years old, acute exposure to flumetralin in drinking water resulted in a di etary risk of < 1.0% of the acute reference dose (aRfD) , which

is well below the Agency’s level of concern. In addition, i ntermediate

- term exposure to flumetralin in drinking water resulted in no risks of concern.10 Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Flumetralin Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Food No Flumetralin is a non

- food use pesticide active ingredient since it is only used on tobacco to control axillary bud (sucker) growth. Dietary exposure to

flu metralin through food is not expected. There is potential for flumetralin to reach drinking water sources through its application to tobacco . The registration review dietary assessment considered dietary exposure to flumetralin in drinking water only

. Dri nking water Yes

- completed EPA conducted an updated a ssessment for flumetralin to incorporate updated drinking water concentrations. Occupational Handlers (mixers, loaders, applicators) Yes

- completed The registration review human health risk assessment did not identify any risks of concern for occupational

handlers of flumetralin

.

In the absence of a n endpoint for dermal toxicity

, dermal handler exposure assessment s were not
conducted . Occupational risk from inhalation exposure to flumetralin was assessed. All occupational handler scenarios for the registered uses

resulted in inhalation MOEs greater than 100 at baseline ( i.e., without respirator y protection ) . MOEs ranged from 3,300 to 44 ,000. HED determined that

n o additional personal protective equipment (PPE)

recommendations (beyond the current recommendations on registered labels) are needed for

flumetralin.

Post

- application No In the absence of a n endpoint for dermal toxicity and in the absence of relevant systemic toxicity, occupational post

- application dermal exposure

assessment s were not conducted for the registration

review of flumetralin

.

Based on the Agency's current pract ices, a quantitative occupational post

- applicat ion inhalation exposure assessment was not performed for

flumetralin . If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post

- application inhalation exposure assessment for flumetralin

.11 Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Flumetralin Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Re

- Ent ry Interval (REI) Yes

- completed In the registration review human health risk assessment, the Agency reviewed the REI on

flumetralin labels. HED is recommending that the

REI be revised to 48 hours on all labels.

Residential

Smoking Yes

- completed It is HED policy to assess only acute exposure to pesticide residues in tobacco products as the chronic

health effects from tobacco use are well documented.

The Agency conducted an assessment of acute inhalation exposure to flumetralin residues in tobac co (via smoking cigarettes). No risks of concern were

identified.

Handlers No A residential handler assessment was n ot completed for registration review because flu m e tralin is not registered for residential use.

Post

- application

Non

- occupational Spray Drift Exposure and Risk Estimates Yes

– completed There are currently no registered or proposed

residential uses for flumetralin

.

Although flumetralin is not registered for residential

use, there is potential for indirect residential exposure via agricu ltural spray drift. EPA conducted a quantitative residential (non

- occupational) post

application spray drift assessment for the registered use on tobacco crops . No r isks of concern were identified at the field’s edge.

Other Aggregate Yes

- completed An aggregate risk assessment e valuates the combined

risk from dietary and residential exposures. EPA conducted an updated aggregate assessment. There are no food or residential uses of flumetralin; therefore, the aggregate risk assessment considered

exposure from drinking water only. Since drinking water exposure resulted in no risks of concern, n o aggregate risks were identified for flumetralin.12 Table 4: Overview of Anticipated Ecological Risk Assessment and Conclusions from Human

Health Draft Risk Assessment for the Flumetralin Registration Review

Type of Risk Assessment To Be

Conducted? Notes

Non

- occupational Bystander

Post

- application Inhalation Exposure and Risk Estimates Will revisit if

necessary V olat ilization of pesticides may be a source of post

application inhalation exposure to individuals nearby

pest icide applications. A tool is being developed for this. Since it is not available for use yet, EPA did not analyze volatilization in the residential p ost

application assessment. During registration review,

EPA will determine if further analysis is required for

flumetralin

. Cumulative No Not applicable; f lumetralin has not been identified as a member of a cumulative group that shares a

common mechanism of toxicity.

Tolerances No Not applicable; no tolerances are required to support

the use of flumetralin on tobacco.

Incidents Will check for updates Based on the low frequency and low severity of incident cases reported for flumetralin , there does not appear to be a concern at this time that would warrant further investigation

. However, t he Agency will

continue to monitor the incident information and if a concern is triggered, additional analysis will be

included in the risk assessment.

For a discussion of reported human incidents for

flumetralin , see Section 10 of the document titled

Flumetralin . Human Health Risk Assessment for Registration Review and see the document titled

Flumetralin : Tier 1 (Scoping) Review of Human Incidents/Epidemiology

.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Submission of existing data on green alga e for EPA review; submission of existing

invert ebrate data for EPA review ; submission of 40 CFR 158 compliant p asserine data; submission of 40 CFR 158 compliant aquatic nonvascular plant data; submission of any existing toxicity data not previously submitted to the Agency . This would help give the Agency a mo re complete understanding of the effects of flumetralin.

• Information on the likelihood of foraging in tobacco fields by birds and mammals given the nicotine in tobacco; information on the magnitude of residues on forage items ; information on the percent of applied flumetralin that is absorbed by tobacco plants . This could help reduce uncertainty and refine conservative assumptions in the Agency’s ecological models.

• M aximum annual application rates per acre (maximum lb ai/A/year) , maximum number of applicati ons per season and/or year, and minimum application intervals on all labels

.13 • Ec ological incidents (non

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

.

• Water quality m onitoring data (s ee Appendix for further details)

.

TIMELINE

EPA has created the following estimated timeline for the completion o f the flumetralin regist ration review in Table 5 below

.

Table 5: Projected Flumetralin Registration Review Timeline

Activity Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period December 2015

Close Public Comment Period February 2016 Case Development

Issue Final Work Plan May 2016

Issue DCI July

– Sept. 2016

Data Submission July

– Sept. 201 8 Open 6 0

- day Public Comment Period for Draft Risk

Assessments 6 Jan.

– March 202 0

Registration Review Decision Open 60

- day Public Comment Period for Proposed Registration Review Decision Oct.

– Dec. 202 0

Issue Registration Review Decision and Begin Post

Decision Follow

- up 2021

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 t he registration

review of flumetralin

.

6 The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk a ssessments; 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.14 Appen dix

– Additional Areas Considered in the Flumetralin 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.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolut ion. The Agency

will work to harmonize tolerances and international maximum residue limits (MRL s ) and may modify tolerance levels to do so, when possible

. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding

the nature of the concern.

Water Quality:

Flumetralin is not identified a s a cause of impairment, as defined under section 303(d) of the

Clean Wate r Act, based on information provided at EPA’s website. 7 In addition, n o Total Maximum Daily Loads (TM DL ) have been developed for flumetralin

. 8 More information on impaired water bodi es and TMDLs can be found at EPA’s website

. 9 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 Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 10 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 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 atypi cal, u nusually high exposure to f lumetralin 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.

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

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

9 http://www.epa.gov/owow/tmdl/

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

- reevaluation/opp

- guidance

- submission

- state

- and

- tribal

- water

- quality

- monitoring

data15 ENDANGERED SPECIES :

A risk assessment that supports a complete endan gered species determina tion h as not been

conducted for flumetralin

. The ecological risk assessment planned during registration review will

allow t he Agency to determine whether use of flumetralin 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 Serv ice and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse

outcom es 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 evaluate s acute tests and chronic studies that assess growth, developmental and reproductive effects in different

taxonom ic groups. As pa rt of its most recent registration and reregistration decision s for

flumetralin

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk

assessment scenarios from the existing hazard database. However, as re quired by FFDCA section 408(p), flumetralin 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

dete rminations. 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 a ny, 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 s creen 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 ingred ients and 9 inert ingre dients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 11 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.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.16 For further information on the status of the EDSP, the policies and procedures, the lists of

c hemicals, future lists, the test guidelines and the Tier 1 screen ing battery, please visit our

website. 12

HUMAN STUDIES :

Occupationa l

Th e current flumetralin human health risk assessment in support of registration review, as well as past flumetralin ri sk assessments

, rely in part on data from studies in which adult hu man 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 Expo sure 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 e ither fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the ti me 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

.

12 http://www2.epa.gov/endo crine

- disruption