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 Environmental 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 noviflumuron 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, initiating the first public comment period for this 

registration review (docket 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 subterranean termites; and 

as an indoor crack and crevice treatment to control cockroaches. There are no registered food or 

agricultural uses, and noviflumuron products are used primarily in residential, commercial, 

institutional, and industrial areas. This Preliminary Work Plan (PWP) document explains what 

EPA's Office of Pesticide Programs knows about noviflumuron, 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 

registration review for noviflumuron. 

 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about noviflumuron and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

noviflumuron. The Agency encourages all interested stakeholders to review the PWP and 

Appendix and to provide comments and additional information that will help the Agency’s 

decision-making process for this chemical. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; commercial, institutional, 

residential, and other users of pesticides; or the public at large. 

The Preliminary Work Plan begins by listing the anticipated data needs for noviflumuron. Next, 

it discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for noviflumuron. 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. 

 
4

ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs 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 

Number1 Study Title1 

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 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 registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.2

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. 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 docket 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;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 the 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 been identified as a member of a 

cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation There are no established tolerances for noviflumuron. 

Dual-use Noviflumuron is registered for conventional pesticidal uses only 

and has no registered antimicrobial or biopesticidal uses. 

Non-pesticidal uses There are no identified non-pesticidal uses of 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 licensed by the state to apply termite 

control products may use noviflumuron

Use Sites Registered for use as a bait around ornamental trees, buildings, 

wood decks, wood fences, wood utility poles for subterranean 
6

Table 3: Noviflumuron Use and Usage Information

termites, and indoor/outdoor crack-and-crevice treatment for 

cockroaches 

Summary of Usage EPA has very limited usage data for noviflumuron due to its nonagricultural use. 

Formulation Type(s)/ 

Application Method(s) 

Noviflumuron products are formulated 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 products3

Restricted Use No 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular 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 technical noviflumuron to the 

US market. 

RECENT ACTIONS 

There are no recent actions for noviflumuron. 

ANTICIPATED RISK ASSESSMENTS 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 gel 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 anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of 

noviflumuron. For human health, EPA does not anticipate the need to conduct revised dietary, 

residential, and occupational risk assessments during registration review. A quantitative risk 

assessment will not be conducted during Registration Review because of negligible human 

exposure from the use pattern of noviflumuron. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 

 

3

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
7

Table 4: Anticipated Risk Assessments 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 and occupational and postapplication exposure is expected 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-application exposure is expected to 

be negligible based on the use pattern. Residential 

handler and occupational and residential postapplication 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 

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 appear 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 already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 

TIMELINE 

EPA has created the following estimated timeline 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 

Assessments4

2018 Oct. – Dec. 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

 2019 July - September

Registration Review Decision 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 issue 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 submissions, or reference to sources of additional information could 

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 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, providing 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 impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.5

 In addition, no Total 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 Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process8 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 noviflumuron 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.htm
11

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 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. 

ENDOCRINE DISRUPTOR 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 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 evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for noviflumuron EPA 

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

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 

noviflumuron 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 

determinations. 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 any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 
12

of chemicals identified for EDSP screening was published on June 14, 20139

 and includes some 

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. 

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

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.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/