2 

### Noviflumuron Preliminary Work Plan – Table of Contents

OVERVIEW ...................................................................................................................... ............. 3

ANTICIPATED DATA NEEDS .................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY ................................................................... 4

CHEMICAL FACTS ................................................................................................................ ...... 5

USE AND USAGE INFORMATION ............................................................................................ 5

RECENT ACTIONS ................................................................................................................ ....... 6

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 6

TIMELINE ...................................................................................................................... ................ 8

NEXT STEPS .................................................................................................................... ............. 8

Appendix – Additional Areas Considered in the Noviflumuron Registration Review ............ 10

References:

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

1. Registration Review Problem Formulation for Noviflumuron

. Koper, C. and E. Odenkirchen. August 19, 2014.

2. Noviflumuron Human Health Scoping Document in Support of Registration Review . Rury, K. and V. Chen. July 15, 2014.

3. Noviflumuron : Tier I Review of Human Incidents

. Evans, E. and S. Recore. May 8, 2014.

These and other supporting documents for the no viflumuron registration review case may be found in the docket EPA-HQ-OPP-2014-0566 at http://www.regulations.gov

.3 OVERVIEW

The docket for noviflumuron is now open, initiati ng the first public comment period for this registration review (docke t number EPA-HQ-OPP-2014-0566). Noviflumuron is a benzoylphenylurea insect growth regulator registered for use as bait around ornamental trees, buildings, wood decks, wood fences, and wood utility poles to control subt erranean termites; and
as an indoor crack and crevice tr eatment to control cockroaches. There are no registered food or agricultural uses, and noviflumur on products are used primarily in residential, commercial, institutional, and industrial areas. This Prelim inary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about noviflumuron, highlighting anticipated data and assessment needs, identifying th e 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 noviflumuron.

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 ab out noviflumuron 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 noviflumuron. The Agency encourages all inte rested stakeholders to review the PWP and Appendix and to provide comments and addition al 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 iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pest icide manufacturers; commercial, institutional, residential, and other users of pes ticides; or the public at large.

The Preliminary Work Plan begins by listing th e anticipated data need s for noviflumuron. Next, it discusses the statutory and re gulatory authority for Registrati on Review. Then the document provides chemical facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration revi ew timeline for noviflumuron. Finally, the Appendix to this document includes identifica tion and discussion of some areas that are considered generally in Registra tion Review along with some a dditional chemical case-specific

information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data need s for noviflumuron. For additional discussion of the anticipated data needs, see the Registration Review Problem Formulation for Noviflumuron

and Noviflumuron Human Health Assessment Scoping Document in Support of Registration

Review

.

Table 1: Anticipated Data Needs for the Noviflumuron Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Noviflumuron
850.2100 Avian acute oral (passerine) TGAI 12 850.2300 Avian reproduction (upland game and waterfowl) TGAI 24

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

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-2009-0154-0028

2 http://www.epa.gov/oppsrrd1/registration_review/5 comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of noviflumuron.

CHEMICAL FACTS

Table 2 provides a summary of th e chemical facts for noviflumuron.

Table 2: Chemical Facts for Noviflumuron

PC code 118204

Case Number 7434

CAS Number 121451-02-3 Year first registered 2003 Pesticide Type Insect growth regulator

Chemical class Benzoylphenylurea Reregistration Eligibility Decision (RED) Not subject to reregistration because this chemical was registered
after 1984.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable. There are no tolerances for this chemical.

Cumulative group Noviflumuron has not b een identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation There are no estab lished tolerances for noviflumuron. Dual-use Noviflumuron is registered fo r conventional pesticidal uses only and has no registered antimicr obial or biopesticidal uses. Non-pesticidal uses There are no identifi ed non-pesticidal uses of noviflumuron.

Pesticide Re-evaluation Division, Chemical Review Manager Dana L. Friedman, friedman.dana@epa.gov , 703-347-8827

Registration Division, Product Manager Mark Suarez, suarez.mark@epa.gov , 703-305-0120

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for noviflumuron.

Table 3: Noviflumuron Use and Usage Information

Summary of Use Noviflumuron is an insect growth regulator registered for use in a bait station to prevent molting and development of subterranean

termites
, and crack-and-crevice treatment for cockroaches. Only pest management professionals license d by t he state to apply termite

control products may use noviflumuron

Use Sites Registered for use as a ba it around ornamental trees, buildings, wood decks, wood fences, wood u tility poles for subterranean6 Table 3: Noviflumuron Use and Usage Information

termites, and indoor/outdoor crac k-and-crevice treatment for

cockroaches Summary of Usage EPA has very limited us age data for noviflumuron due to its nonagricultural use. Formulation Type(s)/ Application Method(s) Noviflumuron products are formulat ed as ready-to-use gel baits in syringe applicators, and as impregnated bait stations. Technical Registrant(s) Dow AgroSciences No. of Registrations 7 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; and geographic limitations on use.

 Usage/use information for non-agricultural uses.

 State or local use restrictions.

 Foreign technical registrants not listed above who supply te chnical noviflumuron to the
US market.

RECENT ACTIONS

There are no recent actions for noviflumuron.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for noviflumuron was completed in September 2005 for a new use request for the ge l bait formulation of noviflumuron. The most recent ecological and environmental fate risk assessment was completed in 2005 for the same purpose. Findings and conclusions from these risk assessments are summarized in the Registration Review Problem Formulation for Noviflumuron and Noviflumuron Human Health Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an enda ngered species assessment, for all uses of noviflumuron. For human health, EPA does not an ticipate the need to conduct revised dietary, residential, and occupational risk assessments during registration review. A quantitative risk assessment will not be conducted during Registra tion Review because of negligible human exposure from the use pattern of noviflumuron.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the
EFED Problem Formulation and HED Scoping Document.

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

(http://oaspub.epa.gov/pestlabl/ppls.home).7 Table 4: Anticipated Risk A ssessments for the Noviflumuron Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y Risk to birds, reptiles, amphibians, and small mammals will be assessed, including endangered species.

Incidents Will check for updates A preliminary review of incidents indicates no reported ecological incidents associated with the use of

noviflumuron. For additional information, see page

14of the Problem Formulation.

Human Health Dietary

Food N Noviflumuron is considered a non-food/non-feed use pesticide; therefore, a dietary (food and drinking water) exposure assessment is not required. Drinking water N

Occupational Handlers (mixers, loaders, applicators) N Occupational handler an d occupational and postapplication exposure is exp ected to be negligible based on the use pattern. Occupational handler and occupational and residential post-application exposure to noviflumuron are expected to be negligible based on the use pattern of noviflumuron. A qualitative risk assessment was previously completed. Post-application N

Residential Handlers N Residential post-appli cation exposure is expected to be negligible based on the use pattern. Residential handler and occupationa l and residential postapplication exposure to novifl umuron are expected to be negligible based on the use pattern of noviflumuron. A qualitative risk assessment was previously completed. Post-application N

Other Aggregate N Evaluates the combined risk from dietary and residential exposures.

Cumulative N EPA has not made a common mechanism of toxicity finding as to noviflumuron and any other substances,
and noviflumuron does not a ppear to produce a toxic metabolite produced by other substances.

Tolerances N There are no tolerances for noviflumuron.8 Incidents Will check for updates For a discussion of reported human incidents for noviflumuron see page 5 of the Scoping Document

and the Noviflumuron : Tier I Review of Human

Incidents

.

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).

TIMELINE

EPA has created the following estimated ti meline for the completion of the noviflumuron registration review in Table 4 below.

Table 5: Projected Noviflumuron Registration Review Timeline

Activities Estimated Date Opening the Docket
Open Docket and 60-day Public Comment Period 2014 – September

Close Public Comment 2014 – November
Case Development
Final Work Plan 2015 – February
Issue DCI 2015 April - June
Data Submission 2017 April - June
60-day Public Comment Period for Draft Risk

Assessments 4 2018 Oct. – Dec.

Registration Review Decision
60-day Public Comment Period for Proposed Registration Review Decision 2019 July - September

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

Total (years) 6

NEXT STEPS

4 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.9 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 noviflumuron.10 

### Appendix – Additional Areas Considered in the Noviflumuron 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. Because noviflumuron is not registered for food/feed uses in the U.S., it has no U.S. tolerances; therefore, the Agency does not anticipate any trade irritant issues for it.

Water Quality:

Noviflumuron is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 5 In addition, no Tota l Maximum Daily Loads (TMDL) have been developed for noviflumuron. 6 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 7 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 8 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 novifl umuron compared to the general population. Please

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

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

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

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm11 comment if you are aware of any sub-populations 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 noviflumuron. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of noviflumuron has “no effect” or “may affect” federally listed threatened or endangered specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service
and/or National Marine Fisheries Service (the Se rvices), 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 noviflumuron 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), noviflumuron is subject to the endocrine screen ing part of the 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 list12 of chemicals identified for EDSP sc reening was published on June 14, 2013 9 and includes some 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. 10

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

chemicals.

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