2 Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of chlorfenapyr. The Final Work Plan includes the expected registration review timeline. The FWP also a ddresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in the chlorfenapyr registration review docket (E PA-HQ-OPP-2010-0467) and any ot her comments concerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agency
believes are needed to make a registration review decision.

The Agency is implementing the registra tion review program and will review each registered pesticide every 15 years to determin e whether it continues to meet the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA) standard for registration. Changes in science, public policy, and pestic ide use practices occur over time. The registration review program is intended to make sure that, as the ab ility to assess risk evolves and as policies and practices change, all registered pesticides contin ue to meet that statutory standard. The public phase of registration review begins when the ini tial docket is opened for e ach case. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

.

Chlorfenapyr (case number 7419) is a pyrrole insecticide and miticide registered for use in greenhouses and other structures to control mites, termites, spider s, and insects. Chlorfenapyr is not a restricted use pesticide. Registered us es of chlorfenapyr include residential settings, but applications can only be made by pest manageme nt professionals. Chlorfenapyr is a proinsecticide (i.e., the biological activity depends on its activation to another chemical). The parent compound is converted to the N-dealkylated meta bolite, which functions as an uncoupler of oxidative phosphorylation in mitochondria. Ch lorfenapyr was first registered in 2001 and therefore was not subject to the reregistration process under FIFRA.

This document makes final the work plan for the chlorfenapyr registration review

processes.

Actions since Publication of PWP

A chlorfenapyr product previ ously contained the following label statement, “Compost any discarded plant material that has been tr eated.” The label language allowing composting has been removed through a label amendment. Th e following prohibition has been added to the revised final label stamped November 2, 2010, “ DO NOT compost any discarded plant materials that have been treated with this product.”

Comments Received on Preliminary Work Plan

On June 23, 2010 EPA opened a 60-day pub lic comment period for the registration review of chlorfenapyr. The comment period ended on August 23, 2010. The Preliminary Work

Plan document can be located in the chlorfenapyr registra tion review docket (EPA-HQ-OPP2010-0467) at www.regulations.gov

.3 During the public comment period, the Agency received comments from the BASF Corporation, the FIFRA Endangered Species Task Force (FESTF), and the Physicians Committee for Responsible Medicine (PCRM). A detailed description of the BASF and PCRM comments as well as the Agency’s response to thes e comments is availabl e in separate response memoranda from the Agency’s Environmental Fate and Effects Divi sion (EFED) and Human Health Effects Division (HED), which can be lo cated in the chlorfena pyr registration review docket (EPA-HQ-OPP-2010-0467) at www.regulations.gov . The Agency’s response to FESTF’s comment is below. The comments received change the anticipated data and risk assessment needs that were described in the PWP; howev er, the timeline remains unchanged. The revised anticipated data and risk assessmen t needs are detailed below.

In the PWP, EPA solicited comments on three specific topics: environmental justice, water body impairment and trade irritants. No comments or information were received during the public comment period concerning these issues.

Comment from FESTF

In June of 2004, March of 2005, and Oct ober 19, 2007, the FIFRA Endangered Species Task Force (FESTF) submitted its Information Management System ( FESTF Information Management System (IMS): Documentati on of Structure and Function of IMS 1.1

, MRID #
46325901 ) and documentation of the beta-tested IMS, NatureServe data ( FESTF Task Force Information Management System (IMS): Beta-Tes ted IMS 2.0 and Access to NatureServe Data - Final Report

, MRID #46486301 ) and NatureServe Data Evaluation and Review ( MRID
#47260101 ). These data fulfill the data requirements spelled out in Pesticide Registration Notice 2000-2 and provide the best available data necessary for the proximity analysis of Chlorfenapyr use and listed species locations.

The leading registrant, as identified on the fact sheet included in the Registration Review Summary, is BASF Corporation (B ASF), a FESTF member. BASF is entitled to rely on FESTF data (See Attachment A for our current list of members and companies who have reached an agreement allowing reliance on FESTF data submissions).

Agency Response

The Agency thanks FESTF for its comment. As discussed below in the Anticipated Risk Assessment and Data Needs section, the Agency has determined that there is no outdoor environmental exposure from the use of chlorfen apyr and will not conduc t an ecological risk assessment during registration review.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting a comprehens ive human health risk assessment for all uses of chlorfenapyr and its metabolites of concer n. Below is a summary of the issues relevant to the registration review process for chlorfenapyr.4 Ecological Risk

In the PWP, the Agency anticipated c onducting a comprehensive ecological risk assessment, including an endangered species asse ssment, for all uses of chlorfenapyr and its
metabolites of concern. This was due to two uses that could result in outdoor environmental exposure. However, due to a label amendment explained below and re-examination of potential environmental exposure, the Agency has determin ed that there is no environmental exposure, and an ecological risk assessment is not needed.

The first use identified in the PWP as ha ving potential outdoor environmental exposure was application to fruiting ve getables grown in a greenhouse. The Agency believed that exposure could occur because the la bel stated to “Compost any dis carded plant material that has been treated.” However, following publication of the PWP, the registrant amended the label to prohibit composting of chlorfenapyr -treated material. Therefore, the Agency has determined that this use no longer results in outdoor environmen tal exposure and an ecolo gical risk assessment

for this use is not needed.

The second use identif ied in the PWP as having potential outdoor environmental exposure

was a pplication to soil underlying a concrete sl ab prior to the slab being poured (during construction) . The PWP stated that there is a potential for exposure to chlorfenapyr in adjacent
areas via runoff from the use site if a major rain event occurred after application but prior to pouring of the concrete slab. However, after re-examining this use pattern, the Agency has determined that the potential for outdoor environmental exposure is ne gligible. This is due to the
fact that a small area would be treated before the concrete was applie d and the time between application and pouring of the concrete slab would be minimal. Therefore, the Agency concludes that outdoor environmental exposure woul d not occur as a result of this use and an ecological risk assessment for th is use is no longer needed.

Refer to the document, Registration Review –Problem Formulation Revised Based on Public Comments for Ecological Risk, En vironmental Fate, and Endangered Species Assessments for Chlorfenapyr (PC Code 129093; DP Barcode 383511) , for a detailed discussion of the anticipated ecological risk assessment needs.

Human Health Risk:

A summary of the anticipated risk assessm ent and data needs for the human health
assessment follows:

• As part of registration review, the Agency anticipates conducting a new dietary risk
assessment which utilizes the most current version of DEEM-FCID TM (2.03). The new dietary exposure assessment will evaluate potential secondary resi dues of chlorfenapyr and its metabolites in/on livestock commodities due to consumption of feed items with chlorfenapyr residues resulting from the estab lished food/feed handling area use. If any proposed uses of chlorfenapyr are deemed to result in contamination of drinking water, estimated drinking water concentrations (EDWCs) will be incorporated in the dietary

assessment.5 • As part of registration review, the Agency also expects to conduc t revised residential postapplication as well as occupational handl er and postapplication assessments. The
revised residential assessment will include dermal and incidental oral routes of exposure. Two occupational handler scenar ios that were not previously assessed will be assessed during registration review and, in addition, several occupational handler scenarios may
need to be assessed in accordance with changes to the hazard assessment. The occupational post application exposure assessment will be conducted using current labeled application rates, updated tran sfer coefficients, and in acco rdance with changes to the

hazard assessment.

• To reflect current Agency policy, the tolera nce expression in 40 CFR Part 180.513 will be reviewed during registration review to ensure that it appropriately covers the metabolites and degradates of chlorfenapyr and that it sp ecifies the residues to be measured for each commodity.

• The FQPA factor will also need to be ev aluated based upon the changes in policy, the developmental neurotoxicity (DNT), 28-de rmal, immunotoxicity, and 90-day inhalation studies. These studies may also lead to revision of the curre nt endpoints for future risk

assessments.

• The Agency anticipates needi ng the following data in order to conduct a complete human health risk assessment for chlorfenapyr:

o Guideline 870.7800 - Immunotoxicity (chlorfenapyr)

• The PWP included guideline 870.3200 - 28-day De rmal Toxicity (r at) and Guideline 870.3465 - 90-day Inhalation Toxicity (rat) as anticipated data needs; however, the studies have been submitted to the Agency. Therefore, it appears at this time that pending review, they may not need to be called in during registration review.

• Please refer to the document, Chlorfenapyr - Human Health Assessment Scoping Document in Support of Registration Review , for a detailed discussion of the anticipated

risk assessment and data needs for human health.

Other anticipated data needs:

• Guideline 830.7050 - UV/Visible Light Abso rption. This study is a new data requirement under 40 CFR Part 158 for regi stration of a pesticide (food and non-food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s identity/composition and the wavelengths at which the compound may be susceptible to photochemical degradation.

Endocrine Disruptor Screening Program:

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may6 designate.” The EDSP employs a two-tiered ap proach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and establish a quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was sele cted based on the potenti al for human exposure through pathways such as food and water, resi dential activity, and cer tain post-application agricultural scenarios. Th is list should not be construed as a list of known or likely endocrine disruptors.

Chlorfenapyr is not among the group of 58 pes ticide active ingredients on the initial list
to be screened under the EDSP. Under FFDCA sec. 408(p) the Agen cy must screen all pesticide chemicals. Accordingly, EPA anticipates issuin g EDSP orders/data call-ins for all Registration Review cases, including those for which EPA ha s already opened a Registration Review docket for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, plea se visit our website: http://www.epa.gov/endo/.

Timeline:

EPA has created the following estimated time line for the completion of the chlorfenapyr registration review.7 Registration Review for Chlorfenapyr – Projected Registration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – June Close Public Comment 2010 – August Case Development

Final Work Plan 2010 – November Issue DCI 2011 – July – Sept. Data Submission 2013 – July – Sept. Open Public Comment Period for Preliminary Risk Assessments 2015 – Jan. – March Close Public Comment Period 2015 – April - June Registration Review Decision Open Public Comment Period for Proposed Registration Review Decision 2015 – July - Sept.

Close Public Comment Period 2015 – Oct. – Dec. Final Registration Review Decision and Begin Post-Decision Follow-up 2016 Total (years) 6

Next Steps

The Agency plans to issue a Data Call-In (DCI) for chlorfenapyr in 2011. These new
data will be used to conduct the risk assessments outlined in this FWP for all chlorfenapyr uses.