Docket Number EPA-HQ-OPP-2015-0098 www.regulations.gov



## Lufenuron Final Wo rk 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

. 1
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 ofthe 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 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/ 2Summarized 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 Comm ents 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 comment s

focus on the EPA ' s duty to consult with th e U. S. Fish and Wildl(f e Se rvice and the N ational 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 report 2 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 ob li gations 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. Gi ven 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
3designated critical habitat, the eco logical 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 ofESA 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-2015-00 98-0011 . 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 Phys ician s Committee f or Res ponsible Medicine in EPA-HQ OPP-2015-0098-0009. Comment: The Physicians Committeefor Responsible Medicine's commentsfocus 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 datafrom 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 4Comm ents submitted by Syngenta in EPA-HQ-OPP -2015 -0098-00 10. Comment: Regardingpasserine acute oral toxicity, S y ngenta argues that , based on information on other species, it is unlikely thatpasserines would ingest enough luf enuron-contaminated termites for the associated risks to be of concern. Syngenta presents a similar argument for the avian reproductive toxicity data cited in th e PWP as a data need. Response : EPA agrees with Syngenta' s rationales on the utility of the avian toxico logy data and concurs that neither study is needed at this time

. PLANNED DATA NEEDS The data needs identified in the PWP were OCS PP Guideline #s 850.2100 , avian oral toxicity (passerine species) , and 850.2300 , avian repro duction . B ased 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 ASSESSMENT S 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 lufenuro n, a quantitative human health risk assessment will not be conducted during Registration Review

. Table 1 below summarizes the p lanned 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

.

5Table 1: Planned Ri sk Assessments for the Lufenuron Regi stration 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 Expos ures 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 volati lization 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 update s lufenuron, see Lufenuron: Tier I Review of Human Incid ents and page 5 of the Scoping Document.
TIMELINE 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.

6Table 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 Assessments 5 April-June 2017 Registration Review Decision 60-day Public Comment Period for Propo sed 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. 7