INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of noviflumuron. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the noviflumuron 

registration review docket (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. 

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

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency’s website.

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The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received during the public comment period for the PWP concerning anticipated data 

needs, expected risk assessments, or the estimated timeline identified in the PWP, and a 

summary of the Agency’s responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected

registration review timeline for noviflumuron. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no updates on noviflumuron since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Noviflumuron Preliminary Work Plan, which 

opened on September 24, 2014 and closed on November 24, 2014 the Agency received two 

public comments. Comments were submitted by the FIFRA Endangered Species Task Force 

(FESTF), Center for Biological Diversity (CBD), and the noviflumuron registrant, Dow 

AgroSciences. The comments do not address the timeline described in the PWP, but they do 

address the planned ecological risk assessment and data requirements. In the PWP, EPA also 

solicited comments on the specific topics of environmental justice, water quality concerns, and 

trade irritants, but no comments or information were received on those issues.

This section does not capture every comment made about the PWP nor all of the Agency’s 

responses. Summarized below are public comments that resulted in changes to the anticipated

1 http://www.epa.gov/oppsrrd1/registration_review/

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registration review data needs, risk assessments, or timeline, or are of a broader regulatory 

nature. Public comments and EPA responses in their entirety are located in the docket, EPAHQ-OPP-2014-0566. Summarized public comments and Agency responses related to the 

anticipated ecological risk assessment or data needs are in the Response to Dow AgroScience 

Comments on Noviflumuron Problem Formulation.

Comments submitted by FIFRA Endangered Species Task Force in EPA-HQ-OPP-2014-

0566-0006.

1. Comment: FESTF submitted a comment informing the Agency that the technical registrant of 

noviflumuron is a member of the FESTF (or a company having met its data compensation 

obligations) and is entitled to rely on FESTF data.

Response: The Agency thanks FESTF for its comment and will take this under consideration.

Comments submitted by Center for Biological Diversity in EPA-HQ-OPP-2014-0566--0007.

2. Comment: Under the Endangered Species Act, it is EPA’s duty to consult with the U.S. Fish and 

Wildlife Service and National Marine Fisheries Service on the reregistration of noviflumuron and 

approval of all noviflumuron end-use product labels. In addition, the EPA must make defensible 

“Not Likely to Adversely Affect” and “Likely to Adversely Affect” determinations as a 

prerequisite for defensible “Jeopardy” and “No Jeopardy” determinations. EPA and the 

services must assess the adverse impacts of noviflumuron in critical habitat.

Response: EPA plans to address many of the concerns raised in the comments from Center 

for Biological Diversity as part of the implementation plan for assessing the risks of pesticides 

to listed species based on the recommendations of the April 2013 National Academy of 

Sciences (NAS) report. EPA will address concerns specific to noviflumuron in connection 

with the development of its registration review decision for noviflumuron. 

The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344, outlines 

recommendations on specific scientific and technical issues related to the development of 

pesticide risk assessments that are compliant with the Endangered Species Act and the Federal 

Insecticide, Fungicide, and Rodenticide Act. In November, the EPA, along with the U.S. Fish 

& Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectively, 

the Services), and the U.S. Department of Agriculture (USDA), released a summary of their 

joint Interim Approaches for assessing risks to listed species from pesticides. The Interim 

Approaches were developed in response to the NAS' recommendations and reflect a common 

approach to risk assessment shared by the Agencies as a way of addressing scientific 

differences between EPA and the Services. The joint Interim Approaches were released prior 

to the stakeholder workshop held on November 15, 2013. EPA presented the joint Interim 

Approaches at the December 2013 PPDC and SFIREG meetings, allowing additional 

opportunities for stakeholders to comment on the Interim Approaches. The Agencies will 

consider public comments on the Interim Approaches prior to implementing them. The 

Agencies intend to jointly implement these approaches as part of a phased iterative 

process. EPA will refine its listed species risk assessments based on these interim 

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approaches. The details of the joint Interim Approaches are contained in the white paper 

"Interim Approaches for National-Level Pesticide Endangered Species Act Assessments 

Based on the Recommendations of the National Academy of Sciences April 2013 Report," 

dated November 1, 2013, available at http://www.epa.gov/espp/2013/nas.html.

Regarding the Center for Biological Diversity's request for EPA to begin informal 

consultation with the Services immediately after the workplan for noviflumuron is finalized, 

EPA plans to follow the March 2013 stakeholder engagement paper ("Enhancing Stakeholder 

Input in the Pesticide Registration Review and ESA Consultation Processes and Development 

of Economically and Technologically Feasible Reasonable and Prudent Alternatives") to 

identify the appropriate time for initiation of consultation, either formal or informal, with the 

Services. The stakeholder engagement paper, jointly developed by the EPA, USDA, and the 

Services and available at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP2012-0442-0038, allows for early interaction with the Services under informal 

consultation. EPA and the Services acknowledge that early interaction as part of informal 

consultation may result in refinements to EPA's effects determinations that can improve the 

efficiency of the ESA compliance process. For example, EPA may involve the Services at the 

earliest stages of registration review. In general, EPA plans to initiate formal ESA 

consultation, if necessary, at the final decision stage in the registration review 

process. Consulting later in the process allows the EPA to develop more refined ecological 

risk assessments and to engage stakeholders in discussions that should result in more focused 

consultation packages that may include risk mitigation for listed species.

Comments submitted by Dow AgroSciences in EPA-HQ-OPP-2014-0566-0008.

3. Comment: Noviflumuron is practically non-toxic to birds and therefore it is reasonable to 

assume that in the unlikely situation that passerine birds feed on termites that have been dosed 

with noviflumuron, the risk posed is very low. This rationale supports waiving the proposed 

avian oral toxicity study. 

Response: The Agency considered the quantitative assessment Dow AgroSciences attached 

with its comments. Compared to a LD50 of >2000 mg/kg/day it appears that the estimated 

dose would be below the empirically demonstrated no-acute lethality value established for 

non-passerine species. This would be even lower if the dose were halved based on the 

assumption that termite concentrations track linearly with bait concentration of noviflumuron. 

The question is whether passerines would have to be much more sensitive in real testing than 

the bobwhite quail to alter this conclusion. Upon considering that the available data are nondefinitive (LD50 is actually greater than limit dose tested) and allowing for the effects of 

allometric scaling (a 20 gram bird projects acute toxicity thresholds a third to a half of those in 

tested quail and mallards), the likelihood for a much disparate acute lethal threshold that 

would alter acute direct lethal risk predictions for passerines is low. In addition, some of the 

assumptions included in calculating an estimated daily dose are highly conservative (e.g., 

treated termites as the only source of food). 

Based on the data available and given the low likelihood of a much different lethal threshold 

for passerines, the Agency will not require the avian acute oral study (850.2100). Please refer 

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to Response to Dow AgroScience Comments on Noviflumuron Problem Formulation for more 

information. 

4. Comment: The proposed avian reproduction studies should be waived because the 

accessibility of birds to treated termites is low and birds will consume both treated and nontreated termites.

Response: Preliminary analysis indicates that treated termites as small percentage of a bird’s 

diet may be a concern for noviflumuron, so even if accessibility is low, the existing residue 

data for noviflumuron suggest that the exposure pathway is complete, inclusive of residues 

within potential prey.

In the absence of a reproduction endpoint for birds, an extrapolation method can be applied 

that uses available acute and chronic data for mammals and the available acute data for birds 

to estimate a reproduction threshold in birds. This method assumes that the relationship in

mammals is conserved in another vertebrate taxon, birds, which was used in the risk 

assessment for the related active ingredient, hexaflumuron. There are limitations to this 

approach, including the need to use surrogate data from hexaflumuron to derive the endpoint 

for noviflumuron. This method does allow the Agency to conduct its non-target avian risk 

assessment for the registration review of noviflumuron. However, this remaining uncertainty 

is an important limitation for conducting an endangered species assessment and it would be 

eliminated by provision of an empirically-based avian reproduction endpoint. Therefore, the 

avian reproduction study is required.

PLANNED DATA NEEDS

The planned data needs for noviflumuron identified in the PWP, and based on the Registration 

Review Problem Formulation for Noviflumuron, have been updated below to reflect public 

comments. The avian oral toxicity study has been removed. For additional information on this 

change, please refer to Response to Dow AgroScience Comments on Noviflumuron Problem 

Formulation.

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Table 1: Anticipated Data Needs for the Noviflumuron Registration Review

Guideline 

Number2 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Noviflumuron

850.2300 Avian reproduction (upland game and waterfowl) TGAI 24

2 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

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RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of noviflumuron. For human health,

EPA does not anticipate changes to the previously completed dietary, residential, and 

occupational risk assessments during registration review. If toxicological endpoints or points of 

departure are revised based on the data that are required for registration review, they will be 

considered in the new assessments, as well as any changes to the standard operating procedures 

or default exposure assumptions.

Table 2 below summarizes the planned registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document and has been updated since the PWP to 

reflect public comments which resulted in changes to the planned risk assessments.

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Table 2: 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 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

Residential

Handlers N Residential 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

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. 

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.

TIMELINE

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EPA has created the following estimated timeline for the completion of the noviflumuron

registration review in Table 3 below. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Noviflumuron – Projected Registration Review 

Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period September 2014 –

Completed

Close Public Comment November 2014 –

Completed

Case Development

Final Work Plan March 2014 –

Completed

Issue DCI 2015 April - June 

Data Submission 2017 April - June 

60-day Public Comment Period for Draft Risk Assessments3 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

As noted previously, the Agency plans to require one ecological effects study for noviflumuron 

through a Data Call-In Notice, expected to be issued in June 2015. 

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

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.

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