2 

### Flufenpyr-ethyl Preliminary 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 RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE ...................................................................................................................... .............. 11

NEXT STEPS .................................................................................................................... ........... 11

Appendix – Additional Areas Considered in th e Flufenpyr-ethyl Registration Review .......... 12

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Registration Review – Problem Formulation fo r the Ecological Risk and Drinking Water Exposure Assessments for Flufenpyr-ethyl

. Wolf, Farruggia, Louie-Juzwiak. December 4,

2014.

2. Flufenpyr-ethyl. Human Health Assessmen t Scoping Document and Preliminary Human

Health Risk Assessment in Support of Registration Review. Tyler, Perron, Venkateshwara. November 26, 2014.

3. New Chemical Review – Environmental Ri sk Assessment for the Proposed Uses of Flufenpyr Ethyl on Sugarcane and Soybeans . Carey, Nguyen, Erickson, Syslo. September 15, 2003.

4. Data Review and Addendum for Flufenpyr-et hyl (S-3153 WDG Herbicide) on Terrestrial Animals, Aquatic Organisms, and Plants . Carey, Smith. November 4, 2003.3 5. Flufenpyr-ethyl: Tier I R eview of Human Incidents . Recore, Evans. August 20, 2014.

These and other supporting documents for the fluf enpyr-ethyl registration review case may be found in the docket EPA-HQ-OPP-2014-0768 at http://www.regulations.gov

.4 OVERVIEW

The docket for flufenpyr-ethyl is now open, ini tiating the first public comment period for this registration review (docket number EPA-HQ- OPP-2014-0768). Flufenpyr-e thyl is a contact herbicide currently registered for the post-emergen ce control of broadleaf weed species, and is a light-dependent peroxidizing herbicide (LDPH). Th is class of herbicides is known to have a photo-toxic mode of action in pl ants and possibly in animals. LDPHs may be more toxic to plants and aquatic animals when exposed to natural sunlight, such as exposure conditions in the field. Flufenpyr-ethyl is formul ated as a water dispersible gra nular. Application equipment and methods for flufenpyr-ethyl in clude ground application, soil band treatment, soil broadcast, direct spray, and aerial applicati on. Flufenpyr-ethyl is registered for use on field corn, soybeans, and sugarcane. There are no registered reside ntial uses for any flufenpyr-ethyl product.

This Preliminary Work Plan (PWP) document expl ains what EPA's Office of Pesticide Programs knows about flufenpyr-ethyl, highlig hting anticipated data and asse ssment needs, identifying the types of information that would be especially useful to the Agen cy in conducting the review, and providing an anticipated timeline for completing th e registration review for flufenpyr-ethyl. This PWP also includes a summary of the draft human h ealth risk assessment fo r registration review. As there are no anticipated human health data needs and only minor updates were required to meet current assessment standards, EPA developed a combined scoping document and draft

human health risk assessment. Bo th that draft human health risk assessment and this Preliminary Work Plan are now in the docket and a 60-day public comment period for them has commenced.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t flufenpyr-ethyl and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on flufenpyr-ethyl. The Agency encourages all in terested stakeholders to review the PWP and Appendix, and associated draft human health ri sk assessment 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-prof it or interest groups; pesticide manufacturers; agricultu ral labor or commodity groups; commerc ial, institutional, residential, and other users of pesticides ; or the public at large.

The Preliminary Work Plan begins by listing th e anticipated data need s for flufenpyr-ethyl. Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use and usag e information, recent act ions, the anticipated ecological risk assessment, a summary of the draf t human health risk assessment, and a projected registration review timeline for flufenpyr-ethyl. Finally, the Appendix to this document includes

identification and discussion of some areas that are considered generally in registration review along with some additional chemical case-specific information.5 ANTICIPATED DATA NEEDS

Table 1 summarizes anticipated data needs for fl ufenpyr-ethyl. For additional discussion of the anticipated data needs, see the Registration Review – Problem Formulation for the Ecological Risk and Drinking Water Exposure A ssessments for Flufenpyr-ethyl and Flufenpyr-ethyl. Human Health Assessment Scoping Document and Pre liminary Human Health Risk Assessment in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Flufenpyr-ethyl Registration Review

Guideline

Number 1 Study Title 1 Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Flufenpyr-ethyl

NonGuideline Honey bee adult acute oral toxicity TGAI 12

NonGuideline Honey bee adult chronic oral toxicity TGAI 12

NonGuideline Honey bee larval acute oral toxicity TGAI 12

NonGuideline Honey bee larval chronic oral toxicity TGAI 12

NonGuideline Semi-field testing for pollinators TEP or

TGAI 24

NonGuideline Field trial of residues in pollen and nectar TEP 24

850.3040 Field testing for pollinators TEP 24
TGAI = technical grade active ingredie nt; TEP = typical end-use product;

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline 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 Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-00286 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 2

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The 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 information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of flufenpyr-ethyl.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for flufenpyr-ethyl.

Table 2: Chemical Facts for Flufenpyr-ethyl

PC code 108853

Case Number 7262

CAS Number 188489-07-8 Year first registered 2003 Pesticide Type LDPH Chemical class Pyridazinone Reregistration Eligibility Decision (RED) Because it was registered afte r November 1984, flufenpyr-ethyl was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable due to flufenpyr-ethyl’s recent registration.

2 http://www.epa.gov/oppsrrd1/registration_review/7 Table 2: Chemical Facts for Flufenpyr-ethyl

Cumulative group Not applicable. Flufenpy r-ethyl has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation Tolerances for flufe npyr-ethyl are established in 40 CFR §180.595. Dual-use Flufenpyr-ethyl is registered for conventional pesticidal uses only and has no registered antimicr obial or biopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses of flufenpyr-ethyl.

Pesticide Re-evaluation Division, Chemical Review Manager Steven Snyderman, snyderman.steven@epa.gov, 703-347-0249

Registration Division, Product Manager Kathryn Montague, monta gue.kathryn@epa.gov, 703-305-1243

USE AND USAGE INFORMATION

Table 3 summarizes the use information for flufenpyr-ethyl based on the 2003 registration

action.

Table 3: Flufenpyr-ethyl Use and Usage Information

Summary of Use Flufenpyr-ethyl is a c ontact herbicide regi stered for the postemergence control of broadleaf weed species. Use Sites Agricultural use on field co rn, sugarcane, and soybeans. No residential or public re creational area uses. Summary of Usage EPA data sources do not reflect any usage of flufenpyr-ethyl since its original registration in 2003. Formulation Type(s) Formulated as a water dispersible granular. Application Method(s) Products can be a pplied by tractor mounted conventional ground sprayer, soil band treatment, so il broadcast, direct spray, and aerial application. Technical Registrant(s) Valent U.S.A. Corporation No. of Registrations Two Section 3 products 3

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

3 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).8  Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

 Usage/use information for non-agricultural uses.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply tech nical flufenpyr-ethyl to the

US market.

RECENT ACTIONS

There are no recent actions for flufenpyr-ethyl.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent ecological and environmental fate risk assessment was completed in 2003 when flufenpyr-ethyl was registered as a new chemical with EPA. A comprehensive human health risk assessment for flufenpyr-ethyl was completed on November 26, 2014, prior to which the most recent human health risk assessment was completed in 2003 for flufenpyr-ethyl’s initial registration. Findings and conclusions from th ese risk assessments are summarized in the Registration Review – Problem Formulation fo r the Ecological Risk and Drinking Water Exposure Assessments for Flufenpyr-ethyl and Flufenpyr-ethyl. Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration

Review.

During registration review, the Agency anticipate s the need to conduct a revised aquatic animal risk assessment, a risk assessment for pollinators, and an endangered species assessment for all uses of flufenpyr-ethyl. If toxi cological endpoints or points of departure are revised based on the data that are anticipated to be required for regist ration review, they will be considered in the new assessment, as well as any changes to the sta ndard operating procedures or default exposure assumptions.

Table 4 below summarizes the recently completed draft human health risk assessment and the anticipated ecological and environmental fate risk assessment for registration review.9 Table 4: Anticipated Ecologica l and Environmental Fate Risk Assessments and Summary of
Draft Human Health Risk Assess ment for the Flufenpyr-ethyl Registration Review

Type of Risk Assessment Conduct/ed? Notes

Ecological and Environmental Fate Ecological risk assessment for aquatic organisms, pollinators, and an endangered species biological

evaluation Y

Incidents Will check for updates There are no reported ecologi cal incidents for flufenpyrethyl.

Human Health Dietary Food Y An updated chronic dietary (food and drinking water) exposure and risk assessment was conducted. The chronic dietary exposure estimates were below the Agency’s level of concern (LOC) for the general U.S. population and all popu lation subgroups. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y An updated occupational exposure assessment for flufenpyr-ethyl was conducted for mixers/loaders, applicators, and flagge rs for aerial and groundboom applications. Inhalation risk estimates were not of concern. EPA assessed only i nhalation exposures since

a dermal hazard was not identified. Post-application N The Agency did not assess post-application dermal exposures since a dermal hazard was not identified. Post-application inhalation exposures were not assessed

either as the handler inha lation exposure estimates are expected to be protective of most occupational postapplication inhalation exposure scenarios.

Residential Handlers N There are no proposed or registered products containing flufenpyr-ethyl that would re sult in residential handler exposure as there are no regi stered residential uses. Therefore, a conventional residential exposure assessment was not performed. However, a quantitative spray drift assessment was c onducted and risk estimates from ground boom and aerial applications are not of

concern. Post-application Y10 Table 4: Anticipated Ecologica l and Environmental Fate Risk Assessments and Summary of
Draft Human Health Risk Assess ment for the Flufenpyr-ethyl Registration Review

Type of Risk Assessment Conduct/ed? Notes

Other Aggregate Y As there are no register ed residential uses, the aggregate risk assessment is equivale nt to the chronic dietary assessment. The chronic aggregate (food + drinking water) exposure and risk es timates did not exceed the Agency’s LOC.

Cumulative N EPA has not made a common mechanism of toxicity finding as to flufenpyr-ethyl and any other substances and flufenpyr-ethyl does not appear to produce a toxic metabolite produced by other substances. Therefore,

EPA has assumed that flufe npyr-ethyl does not have a common mechanism of toxicity with other substances. Tolerances Y The tolerance expr ession for flufenpyr-ethyl was

reviewed and recommendations for updates were made on page 7 of Flufenpyr-ethyl. Human Health Assessment Scoping Document and Preliminary Human

Health Risk Assessment in Support of Registration

Review.

Incidents Will check for updates There were no incidents involving flufenpyr-ethyl reported to either OPP Incide nt Data System (IDS) or Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides for the time period from

1998 to 2010.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).11 TIMELINE

EPA has created the following estimated timelin e for the completion of the flufenpyr-ethyl registration review in Table 5 below.

Table 5: Projected Flufenpyr-et hyl Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 4 2014 – December Close Public Comment 2015 – February Case Development Final Work Plan 2015 – May Issue DCI 2015 July – Sept. Data Submission 2017 July – Sept. 60-day Public Comment Period for Draft Risk

Assessments 5, 6 2019 Jan. - March

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 Oct. – Dec.

Registration Review Decisi on and Begin Post-Decision Follow-up 2020

Total (years) 6

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration review of flufenpyr-ethyl.

4 The Agency is seeking comment on the PWP and the dr aft human health risk assessment during this comment period.

5 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.

6 The Agency expects to seek comment on the draft ecological and environmental fate risk assessments at this time.12 

### Appendix – Additional Areas Considered in the Flufenpyr-ethyl Registration
Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) 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, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Flufenpyr-ethyl is not identified as a cause of impairment for any wa ter bodies listed as impaired under section 303(d) of the Clean Water Act. 7 In addition, no Tota l Maximum Daily Loads (TMDL) have been developed for flufenpyr-ethyl. 8 More information on impaired water bodies and TMDLs can be found at the Agency’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 Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 10 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to flufenpy r-ethyl 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://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm13 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for flufenpyr-ethyl. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of flufenpyr-ethyl has “no effect” or “may affect” federally listed threatened or endangere d species (listed species) or their designated

critical habitats. When an assessment conclude s that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildlife

Service and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most rece nt registration decisi on for flufenpyr-ethyl, EPA
reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), flufenpyr-ethyl is subject to th e endocrine screening part of th e Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredient s and 9 inert ingredients. A second list

of chemicals identified for EDSP sc reening was published on June 14, 2013 11 and includes some

11 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.14 pesticides scheduled for registration review and chemicals found in water

. Neither of these lists

should be construed as a list of know n or likely endocri ne disruptors.

For further information on the status of the ED SP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our

website. 12

HUMAN STUDIES:

Occupational

Past flufenpyr-ethyl risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pest icide to determine their dermal and inhalation exposure. Many such studies, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pest icide Handlers Exposure Database (PHED), the Agricultural Handler Exposure Task Force (AHETF) database, and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporti ng these multi-pesticide generic exposure databases, and has found no cl ear 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 wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies.

12 http://www.epa.gov/endo/