Docket Number EPA-HQ-OPP-2015-0098 

www.regulations.gov 

Lufenuron Final Work Plan 

Registration Review 

Case Number 7627 

September 2015 

Approved by: :i3:=;h~ p l.AA./ 'b 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: 

INTRODUCTION 

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

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

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

review docket (EPA-HQ-OPP-2015-0098). Lufenuron is a benzoylurea insecticide registered for 

use against subterranean termites. There are no registered food or agricultural uses, and 

lufenuron products are registered for use to control active infestations in structures including 

houses, apartment buildings, industrial buildings, laboratories, non-food/feed areas of stores, 

warehouses, schools, nursing homes, hospitals, restaurants, and hotels. 

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 time line for lufenuron. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on lufenuron since the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

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

opened on March 30, 2015 and closed on May 29, 2015, the Agency received four public 

comments. Comments were submitted by Syngenta, Center for Biological Diversity (CBD), 

Physicians Committee for Responsible Medicine, and FIFRA Endangered Species Task Force 

(FESTF). CBD and FESTF's comments addressed endangered species data, risk assessment, 

and the consultation process. The Physicians Committee for Responsible Medicine suggested an 

alternative approach to data development that would reduce the number of animals to be tested. 

Syngenta provided editorial comments and valuable usage information, and also presented 

rationales for not requiring two ecotoxicology studies. In the PWP, EPA also solicited 

comments to the specific topics of environmental justice, water quality concerns, and trade 

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

1 http://www.epa.gov/oppsrrd (/registration _review/ 

2 

Summarized below are public comments from CBD, Physicians Committee for Responsible 

medicine, FESTF and Syngenta to the anticipated registration review data needs, risk 

assessments, or timeline, or are of a broader regulatory nature. The Agency responses related to 

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

Comments Received on the Problem Formulation. Public comments and EPA responses in their 

entirety are located in the docket, EPA-HQ-OPP-20 15-0098. 

Comments submitted by CBD in EPA-HQ-OPP-2015-0098-0008. 

Comment: CBD 's comments focus on the EPA 's duty to consult with the U. S. Fish and Wildl(fe 

Service and the National Marine Fisheries Service (the Services) on the registration review of 

lufenuron, in accordance with the ESA. The CBD comments mention various aspects of the risk 

assessment and management processes for listed species, including use of the best available data 

to develop endangered species risk assessments. and evaluation of effects on endangered and 

threatened species and their designated critical habitat. 

Response: EPA has reviewed the comments from CBD on the lufenuron PWP and plans to 

address many of the concerns raised by CBD 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 lufenuron in 

connection with the development of its registration review decision for this pesticide. 

In November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to endangered and threatened (listed) species 

from pesticides. The Interim Approaches were developed jointly by the agencies in response to 

the National Academy of Sciences' (NAS) recommendations and reflect a common approach to 

risk assessment shared by the agencies as a way of addressing scientific differences between the 

EPA and the Services. The NAS report2 outlines recommendations on specific scientific and 

technical issues related to the development of pesticide risk assessments that EPA and the 

Services must conduct in connection with their obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on November 

15, 2013 . In addition, the EPA presented the joint Interim Approaches at the December 2013 

Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and 

Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April 

and October 2014, allowing additional opportunities for stakeholders to comment on the Interim 

Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of 

a phased, iterative process for developing the Interim Approaches, the agencies will also 

consider public comments on the Interim Approaches in connection with the development of 

upcoming Registration Review decisions. 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 

April2013 Report" 3, dated November 1, 2013. 

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

2 http://www.nap.edu/catalog.php?record_id=18344 

3 http://www.epa.gov/espp/20 13/nas.html 

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designated critical habitat, the ecological problem formulation supporting this Final Work Plan 

for lufenuron does not describe the specific ESA analysis, including effects determinations for 

specific listed species or designated critical habitat, to be conducted during registration review. 

In the ecological problem formulation document, EPA described the screening-level risk 

assessment to determine the potential effects of lufenuron on all taxa of non-target wildlife and 

plants, which will assume that listed species and their designated critical habitats may be present 

in the vicinity of the application of lufenuron. This screening-level assessment will allow EPA 

to focus its future evaluations on the types of species where the potential for effects exists once 

the scientific methods being developed by the agencies have been fully vetted. While the 

agencies continue to develop a common method for ESA analysis, the planned screening-level 

risk assessment for the registration review of lufenuron will describe the level of ESA analysis 

completed for this particular registration review case. Once the agencies have fully developed 

and implemented the scientific methods necessary to complete risk assessments for endangered 

and threatened (listed) species and their designated critical habitats, these methods will be 

applied to subsequent analyses for lufenuron as part of completing this registration review. 

Comments submitted by FESTF in EPA-HQ-OPP-2015-0098-0011. 

Comment: FESTF's comments concern the endangered species assessment and data developed 

by the Task Force on species proximity to areas treated with pesticides, including lufenuron. 

FESTF notes that the technical registrant for lufenuron, Syngenta, is a FESTF member and 

entitled to rely on FESTF data. 

Response: EPA thanks FESTF for its comments and will consider all appropriate information 

for its endangered species assessment and in developing the registration review decision. 

Comments submitted by Physicians Committee for Responsible Medicine in EPA-HQOPP-2015-0098-0009. 

Comment: The Physicians Committee for Responsible Medicine's comments focus on the data 

required for the registration review for lufenuron, recommending that OECD guideline 223 be 

usedfor the acute avian oral toxicity test (OCSPP Guideline 850.2100) in order to reduce the 

number of animals needed for testing. The comments also recommend that the Agency review 

data from the European Food Safety Authority on reproductive endpoints for bobwhite quail. 

Response: EPA appreciates the comment and will consider all available data as appropriate in 

support ofthe risk assessment. Careful consideration ofthe limitations and appropriateness of 

using non-Guideline studies is needed. As an example, OECD guideline 223 recommends using 

test species with low background mortality and a low propensity to regurgitate (historically, 

these would be the Bobwhite quail and Japanese quail). The test design may not be appropriate 

for use with other test species (e.g., passerines). Specific considerations are described in the 

document: "Guidance for Classifying Studies Conducted Using the OECD Test Guideline 223 

(TG223) (Acute Avian Oral Sequential Dose Study)."4 However, based on a review of the 

comments of Syngenta (summarized below), the Agency has determined that the passerine acute 

toxicity data identified in the lufenuron PWP are not needed for risk assessment. 

4 http://www.epa.gov/pesticides/science/efed/policy guidance/team authors/terrestrial biology tech 

team/review_ avian_ acute_ oral_ oecd _ tg223 .htm 

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Comments submitted by Syngenta in EPA-HQ-OPP-2015-0098-0010. 

Comment: Regarding passerine acute oral toxicity, Syngenta argues that, based on information 

on other species, it is unlikely that passerines would ingest enough lufenuron-contaminated 

termites for the associated risks to be of concern. Syngenta presents a similar argument for the 

avian reproductive toxicity data cited in the PWP as a data need. 

Response: EPA agrees with Syngenta' s rationales on the utility of the avian toxicology data and 

concurs that neither study is needed at this time. 

PLANNED DATA NEEDS 

The data needs identified in the PWP were OCSPP Guideline #s 850.2100, avian oral toxicity 

(passerine species), and 850.2300, avian reproduction. Based on its consideration ofthe public 

comments, the Agency is not at this time planning to call-in any data for the registration review 

of lufenuron. 

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 lufenuron. Because of the negligible 

exposure from the registered uses of lufenuron, a quantitative human health risk assessment will 

not be conducted during Registration Review. 

Table 1 below summarizes the planned registration review risk assessments based on the 

Problem Formulation and Scoping Document; the planned assessments have not changed from 

what was included in the PWP. 

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Table 1: Planned Risk Assessments for the Lufenuron Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Incidents Will check for For a discussion of reported ecological incidents for 

updates lufenuron, see page 9 ofthe Problem Formulation. 

Human Health 

Dietary 

Food N Exposures are expected to be negligible. 

Drinking water N 

Occupational 

Handlers (mixers, loaders, N Based on the use pattern, occupational handler and 

applicators) post-application exposure to lufenuron are expected to 

Post -application N be negligible. 

Residential 

Handlers N Labeling indicates that only pest management 

Post -application N professionals licensed to apply termite control 

products by the state may use lufenuron products. 

Neither a bystander spray drift assessment nor a 

volatilization screen is needed. 

Other 

Aggregate N Evaluates the combined risk from dietary and 

residential exposures. Lufenuron is a non-food/nonfeed use pesticide, so a dietary assessment is not 

required. Additionally, lufenuron is used in 

residential settings, but exposure is expected to be 

negligible. 

Cumulative N Lufenuron is not a member of a cumulative group. 

Tolerances N Lufenuron is a non-food/non-feed use pesticide, so no 

tolerances are established. 

Incidents Will check for For a discussion of reported human incidents for 

updates lufenuron, see Lufenuron: Tier I Review of Human 

Incidents and page 5 of the Scoping Document. 

TIME LINE 

EPA has created the following estimated timeline for the completion of the lufenuron registration 

review in Table 2 below. The projected timeline has been updated to reflect impacts of public 

comments received and changes to the planned data needs. 

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Table 2: Registration Review for Lufenuron- Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period March 2015-

Completed 

Close Public Comment May 2015 - Completed 

Case Development 

Final Work Plan September 2015 -

Completed 

60-day Public Comment Period for Draft Risk Assessments5 April-June 2017 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review 2018: January- March 

Decision 

Registration Review Decision and Begin Post-Decision Follow-up 2018 

Total (years) 3 

NEXT STEPS 

The Agency has reconsidered the planned data needs for lufenuron cited in the PWP. The 

Agency does not anticipate requiring any data at this time, and the projected timeline has been 

revised to show that the Agency does not anticipate issuing a Data Call-In at this time. 

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. 

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