I NTRODUCTION

This is the Environm ental 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

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- 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, an d 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 (F IFRA), 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 f or each case.

Informatio n 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 anticipat ed data

needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se 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 For ce (FESTF) , Center for Biological Diversity (CBD), and the noviflumuron registrant, Dow

A gro Sciences . 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/

2registration review data needs, risk assessments, or timeline, or are of a broader regulatory

nature. Public comments and EPA responses in th eir entirety are located in the docket, EPA

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- 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 Formu lation.

Comments submitted by FIFRA Endangered Species Task Force in EPA

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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 i ts 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

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. 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 addit ion, 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 novifl umuron 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 a nd 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 Ap proaches 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 present ed 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 wi ll 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

3approaches. 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 Repor t," 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 immediate ly 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 Techn ologically 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

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- 0038 , allows for early interaction with the Services under informal

consultati on. 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 Service s 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 refin ed 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.

C omments submitted by Dow Agr o Sciences in EPA

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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 Agro Sciences 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 qu estion 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 non

definitive (LD50 is actually greater than limit dose tested) and allowing f or 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 predictio ns 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).

B ased on the data available and given the low likelihood of a mu ch different lethal threshold for passerines

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

4to 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 bi rds to treated termites is low and birds will consume both treated and non

treated termites.

Response: Preliminary analysis indicates that treated termites as small perc entage 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 t he exposure pathway is complete, inclusive of residues within potential prey.

In the absence of a reproduc tion 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. Th is method assumes t hat the relationship in

mammal s is conserved in anoth er 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 no viflumuron

. However, this remaining uncertainty is an important limitation for conducting an endangered species assessment and it would be eliminated by provision of an empirically

- ba sed avian reproduction endpoint . Therefore, the avian reproduction stud y 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.

. Table 1: Anticipated Data Needs for the Noviflumuron Registration Review

Guideline

Number 2 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata 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

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5RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he 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

o ccupational risk assessment s 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 assessment s
, as well as any changes to the standard operating p rocedures 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 assessment s

.

6Table 2 : Anticipated Risk Assessments for the Noviflumuron Registration Review

Type of Risk Assessment Conduct? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y Risk to b irds, 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 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 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 E valuates 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 substa nces. 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

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TIMELINE

7EPA 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 D ocket 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 Assessments 3 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 pro vide a 60 calendar day public comment period generally for draft risk assessments.

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