Page 2 of 8 Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of clothianidin . The FWP includes the expected registration review timeline. The FWP also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document , which was posted in the clothianidin registration review docket (EPA

- HQ

- OPP

- 2011

- 0 865 ), and any other 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 r egistration review decision.

The Agency is implementing the registration review program and will review each registered pesticide every 15 years to determine whether it continues to meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) stan dard 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 register ed 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 at: http://www.epa.gov/oppsrrd1/registration_review/

.

Clothianidin is a broad

- spectrum, systemic neonicotinoid insecticide registered for use to control chewing and sucking pests on a number of row and tree crops and turf. It is also registered for use i n poultry houses and recreational and residential settings. Clothianidin induces paralysis and death in insects by enhancing nicotinic acetylcholine receptor activity. Clothianidin is a degradate of thiamethoxam that is also going through the registratio n review process (Case # 7614). Products containing c lothianidin were first registered in 2003 and, therefore, clothianidin was not subject to reregistration.

Comments Received on and Changes Made Since the Preliminary Work Plan

On December 21, 2011 EPA opened a 60

- day public comment period on the PWP for the registration review of clothianidin . During the public comment period the Agency received more than 120,000 comments. Most comments were the result of a letter writing campaign asking EPA to s uspend the use of clothianidin. However, there were several comments on the use of clothianidin and some substantive comments from registrants and other stakeholders. Comments received did not result in a modification to the anticipated data needs or timeline detailed in the clothianidin PWP. However, there were three studies which were listed in error as required in the PWP and one study that was erroneously omitted from the PWP

. The required data list in this FWP corrects these errors . For detail s see Table I at the end of this document.

On March 20, 2012, the EPA received an emergency citizen petition seeking suspension of registration for clothianidin. The petition requested action within 90 days. The agency is reviewing the petition and is in the process of responding to the petitioners' allegation that clothianidin poses an imminent hazard to pollinators. Many of the matters raised in the March 20, 2012 petition were also received as comments during the 60 day comment period on the Preliminar y Work Plan (PWP) for the Registration Review of Clothianidin . Comments receivedPage 3 of 8 on the PWP that are duplicated in the March 20, 2012 petition will only be responded to in the Agency’s responses to this petition

. An overview of the comments and the Age ncy’s response is presented in the “Summary of Comments and Agency Respons es” section of this document.

Risk Assessment and Data Needs

The Agency anticipates conducting a comprehensive ecological risk assessment, including an endangered species assessmen t , and a revised human health risk assessment for all uses of clothianidin

. The following is a summary of the issues relevant to the registration review of clothianidin

. Ecological Risk:

• The most recent ecological risk assessment for clothianidin was completed in 2010 in support of the registration of clothianidin for use as seed treatmen ts on mustard and
cotton.

• The Agency has not conducted a risk assessment that supports a complete endangered species determination for clothianidin . The ecological r isk assessment planned during registration review will allow the Agency to determine whether clothianidin ’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

• On Ja nuary 19, 2011, the Center for Biological Diversity and the Pesticide Action Network North America filed a lawsuit in the United States District Court for the Northern District of California, against the EPA for allegedly failing to undergo consultation wi th the United States Fish and Wildlife Service and the National Marine Fisheries Service regarding the effects of over 350 pesticides, including clothianidin , on over 200 endangered and threatened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C 11

- 00293 (N.D.Cal.)

.

• Previous risk assessments have assessed most major and minor degradates and the Agency concluded that they are expected to be as toxic or less toxic than parent clothianidin. Uncertainty regarding the clothianidin degradate thiazolylmethylguanidine (TMG) remain and the Agency will requir e data on th is degradate to support registration review.

• The environmental fate and effects database is largely complete for clothianidin with the exception of effects data on avian and terrestrial invertebrate species.Page 4 of 8 • B ased upon the current use pattern and the current available database on clothianidin , the Agency is requiring the following ecological fate and effects data for use in conducting a complete ecological risk assessment, including an endangered species assessment

.

GLN 850.2100 Acute avian oral toxicity for passerines

GLN 850.3040 Field testing for pollinators (T EP)

Non

- Guideline Pollinator larval toxicity

Non

- Guideline Laboratory pollinator feeding study

Non

- Guideline Residues in pollen and nectar/field residue analysis study Non

- Guideline Chronic sediment toxicity test with midge larvae (with TGAI and the degradate TMG) Non

- Guideline Poultry litter residue study

835.7100 Prospective groundwater study

• T o further evaluate risks to pollinators and other beneficial insects, EPA is requiring data to assess bees as a representative for all beneficial insects. In moving forward with addressing potential risk to these organisms, EPA will consider the recommendations of the Society of Environmental Toxicology and Chemistry (SETAC) Workshop on Pes ticide Risk Assessment for Pollinators, and is working with its federal and state partners, industry, and academia to determine appropriate assessment methodology. For compounds, such as clothianidin , which (1) show acute toxicity to bees and (2) have
exp osure routes for bees, EPA will requir e toxicity and exposure studies to allow for evaluation of risks to pollinators. The registrant should consult with EPA on the conduct of these studies.

• The prospective groundwater study was included as a data gap in Registration Review: Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments of Clothianidin , dated December 13, 2011, but was erroneously omitted from the PWP. The Agency will requi re this study to support registration review.

• Please refer to the document, Registration Review: Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments of Clothianidin , dated December 13, 2011

, located in the docket for a detailed discussion of the anticipated risk assessment and data needs.

Human Health Risk:

• The most recent comprehensive human health risk assessment for clothianidin was completed in 2009 to support new use registrations on berries, Brassica vegetables,Page 5 of 8 cotton, cucurbits, fig, fruiting vegetables, leafy vegetables, peach, pomegranate, soybean, tree nuts, and tuberous and corm vegetables

.

• T he Agency will require the following data for u se in the registration review of clothianidin:

GLN 870.3465 90 day inhalation toxicity GLN 875.2100 Turf transferable residue study Special Study Residue chemistry comparisons of different formulations on select commodities

• Side

- by

- side trials comparing residues from the WDG and SC formulations for leafy vegetables, Brassica vegetables, non

- bell peppers . Furthermore, HED determined that side

- by

- side trials were needed to demonstrate the effect of spray mix adjuvants on resid ue levels.

• Side

- by

- side trials comparing residues from foliar and soil applications to leaf lettuce, mustard greens, peppers, and cucumbers.

• For the human heal th risk assessment, the residue of concern for the dieta ry assessment ( i.e. , drinking water) is parent clothianidin. To support the registration review of clothianidin, the Agency will update the dietary risk assessment for clothianidin to incorporate any changes in policy.

• The Agency will conduct a new residential exposure assessment to incorporat e changes in policy and to incorporate new data from the turf transferable residue study that is required.

• The Agency will calculat e new aggregate risk estimates during this registration review to incorporate any revisions to dietary or residential exposu re estimates

.

• In addition to the dermal and oral hand

- to

- mouth residential exposure assessments, residential bystander inhalation exposures resulting from off

- site transport (e.g., spray drift or volatilization) may occur as a result of applications of clothianidin

. The Agency is in the process of examining its policies and processes regarding assessment of these types of residential exposures. Therefore, t he potential need for a bystander inhalation risk assessment for clothianidin will be examined du ring registration review.

• The Agency will updat e the occupational handler and post application risk assessment, especially for seed treatment uses, to incorporate changes in policy and new agricultural transfer coefficients.

• The tolerance expression for clothianidin will be reviewed during registration review to ensure that it appropriately covers the metabolites and degradates of clothianidin and that it specifies the residues to be measured for each commodity.Page 6 of 8 • The Agency will modify tolerance levels as needed, and work to harmonize tolerances/maximum residue limits (MRL), where possible, in key export markets during registration review.

• Please refer to the document, Clothianidin. Human Health Assessment Scoping document in Support of Registration Revie w, dated December 8 , 2011 , located in the docket for a detailed discussion of the anticipated risk assessment and data needs for human health.

Timeline

EPA has created the following estimated timeline for the completion of the clothianidin registration review.

Registration Review for Clothianidin

– Projected Registration Review Timeline
Activities Estimated Date Opening the D ocket Open Docket and Public Comment Period 2011

– December Close Public Comment 2012

– February Case Development Final Work Plan 2012

– June Issue DCI 2013

– Jan.

– March Data Submission 2016

– Jan.

– March Open Public Comment Period for Draft Risk Assessments 2017

– July

– Sept. Close Public Comment Period 2017

– Oct.

– Dec. Registration Review Decision Open Public Comment Period for Proposed Registration Review D ecision 2018

– Jan.

– March

Close Public C omment P eriod 2018

– April

– June Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 Total ( years ) 7

Next Steps:

The Agency will require ecological effects and a human health studies through a d ata c all

- i n (DCI) , which is expected to be issued in early 2013. This new information will be used to conduct risk assessments for all registered uses of clothianidin

.
Summary of Comme nts Received During Docket Opening

On December 21, 2011 EPA opened a 60

- day public comment period on the PWP for the registration review of clothianidin. The comment period ended on February 21, 2012. Due to the quantity of comments received the Agency accepted comments until February 28, 2012. During the public comment period the Agency received more than 120,000 comments.Page 7 of 8 Comments received did not result in a modification to the anticipated data needs or timeline detailed in the clothianidin PWP.

The majority of the comments were received as a result of a letter writing campaign organized by Beyond Pesticides (BP) and Pesticide Action Network of North America (PANNA) voicing concern that clothianidin presents unacceptable risks to pollinators. The Agency received similar comments, i.e., concern over the risk to pollinators, from beekeepers, private citizens, the National Honey Bee Advisory Board (NHBAB) , and the Rachel Carson Council

. The Agency also received numerous comments in support of clot hianidin from numerous grower and commodity groups; seed manufacturers ; and academics. The technical registrant Valent and the end use registrant Bayer CropScience provided comments regarding the Agency’s ecological risk assessment, the drinking water ass essment, and on the anticipated data requirements discussed in the Clothianidin Preliminary Work Plan. Valent also commented on trade irritants and conditionally required magnitude of residue studies.

Finally, in the PWP , EPA solicited comments on three specific topics: environmental justice, water body impairment s , and trade irritants. During the comment period the Agency rec eived one comment on trade irritants and no c omment on environmental justice and water body impairments.

Comments regarding the ecological fate or effects of clothianidin have been addressed by the Environmental Fate and Effects Division’s document, EFED Response to Comments Submitted to the Clothianidin Registration Review Docket (dated June 11 , 20 12). Comments regarding policy, process , and benefits have been addressed in

, Clothianidin : PRD Response to Comments on Registration Review PWP (Dated June 20 , 20 12 ). Both documents are available in the docket (EPA

- HQ

- OPP

- 20 11

- 0865 ).Page 8 of 8 Data Requirements Table

The table below summarize s data requirement needs for clothianidin . For additional discussion of the data requirement needs, see the Registration Review: Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Exposure Assessment s of Clothianidin , dated December 13, 2011 ; and Clothianidin. Human Health Assessment Scoping document in Support of Registration Review, dated December 8, 2011

.

* The prospective groundwater study was erroneously omitted from the PWP. Table 1

. Clothianidin Registration Review Data Requirements Data Requirement Guideline Number Listed In PWP Listed In FWP

90 day inhalation toxicity GLN 870.3465 Yes, these studies are listed in both the PWP and FWP. The Agency will issue a DCI for these studies. Turf transferable residue study GLN 875.2100 Residue chemistry comparisons of different formulations on select commodities

• Side

- by

- side trials comparing residues from the WDG and SC formulations for leafy vegetables, Brassica vegetables,

non

- bell peppers . Furthermore, HED determined that side

- by

- side trials were needed to demonstra te the effect of spray mix adjuvants on residue levels.

• Side

- by

- side trials comparing residues from foliar and soil applications to leaf lettuce, mustard greens, peppers, and cucumbers. Non

- Guideline

Acute avian oral toxicity for passerines 850.2100 Field testing for pollinators (TEP) 850.3040 Pollinator larval toxicity Non

- Guideline Laboratory pollinator feeding study Non

- Guideline Residues in pollen and nectar/field residue analysis study Non

- Guideline Poultry litter residue study Non

- Guideline Chronic sediment toxicity test with midge larvae (with TGAI and the degradate TMG) Non

- Guideline

Prospective groundwater study * 835.7100 No Yes Honey bee toxicity of residues on foliage (TEP) 850.3030 Yes No. The Agency is only interested in a dditional information from an existing alfalfa residue study

. Aquatic field dissipation (In Review) 835.6200 Yes No. If the study under review is found to be

u nacceptable, the Agency will make conservative assumptions. Chronic sediment toxicity test with midge larvae (the degradate TZNG) Non

- Guideline Yes No. Chronic sediment toxicity testing with midge larvae on the degradate TZNG will not be required to support registration review.