2 of 3 Introduction:

This document amends the Final Work Plan (FWP) for the registration revi ew of imidacloprid. Since the publication of the June 2009 Final Work Plan for the registration review of imidacloprid, the Agency has identified additional data necessary to support the registration review of imidacloprid. This document amends the June 2009 Imidacloprid FWP to include the revised ecological data requireme nts and the revised registration review schedule to account for the additional data requirements. Unless otherwise stated in this amendment, all other elements of the Agency’s 2009 Imidacloprid FWP remain unchanged. Rationales for the additional data requirements can be found in the document entitled “Imidacloprid: Amended Data Requirements for Registration Review” (D378465). This document as well as other supporting

documents can be found in the imidacl oprid docket (EPA-HQ-OPP-2008-0844) at http://www.regulations.gov

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The Agency is implementing the Registration Re view program, pursuant to FIFRA section 3(g), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Cha nges in science, public policy, and pesticide use practices will occur over time. The registration re view program is intended to make sure that, as the ability to assess risk evolves as policies a nd practices change, all registered pesticides continue to meet that statutory standard. The public phase of re gistration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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Imidacloprid is a systemic neonicotinoid nitr oguanidine insecticide used on food crops, ornamentals, turf, seed treatments, domestic pets, and structural pests. Imidacloprid’s mode of toxic action is the disruption of the nervous sy stem by acting as an in hibitor at nicotinic acetylcholine receptors. It was first registered for use in 1994, and as a result was not reviewed under the reregistration process.

Changes to the Ecological Data Needs:

Following additional review of available imidacloprid data, the Agency has concluded that it lacks adequate exposure data to es timate potential risk to terrestr ial invertebrates. Imidacloprid is a systemic insecticide that is taken up by a plant’s roots, and tran slocated throughout plant tissues resulting in residue con centrations in different plant tis sues. The Agency does not have adequate data to understand the pot ential exposure of imidacloprid to terrestrial invertebrates that may be exposed to imidacloprid through reliance on plant flower parts for habitat or diet. In addition to the ecological, fate, and human health data requirements identified in the June 2009 FWP for imidacloprid, the Agency will also re quire the following exposure data to support registration review:3 of 3 • Field Residue Test (Special St udy): Imidacloprid residues in L eaves and/or Nectar and/or Pollen (2 Years) in the following crops: Crop Matrices

o Citrus Leaves, Nectar, and Pollen

o Blueberry Leaves, Nectar, and Pollen

o Stone Fruit (Apples or Cherries) Leaves, Nectar, and Pollen

o Cotton Leaves and Nectar

o Corn Leaves and Pollen

Revised Timeline:

To accommodate the additional 2-year field studies, the Agency will adopt the amended schedule for the registration review of im idacloprid as outlined below.

Revised Registration Review Schedule for Imidacloprid

Activities Estimated Month/Year

Phase 1: Opening the Docket Open Public Comment Period for Imidacloprid Docket Completed 2008– Dec. Close Public Comment Period Completed 2009– Mar. Phase 2: Case Development Final Work Plan (FWP) Completed 2009– Jun.

Amend FWP 2010– Jul. Issue DCI 2010– Aug. Data Submission 2013– Jul.-Aug. Preliminary Risk Assessment & Public Comment 2015– Jan.-Mar. Close Public Comment Period 2015– Apr.-Jun. Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision 2015– Jul.-Sep.

Close Public Comment Period 2015– Oct. – Dec. Final Decision and Begin Post-Decision Follow-up 2016– Jan-Mar.

Total 8 yearsIntroduction:

This is EPA’s Final Work Plan (FWP) for the registration review of imidacloprid. The FWP includes the expected registration review time line. The FWP also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in the initial registration review docket (EPA-HQ-OPP-2008- 0844), and any other

comments on 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 Registration Review program, pursuant to FIFRA section 3(g), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Change s in science, public po licy, and pesticide use practices will occur over time. The registration re view program is intended to make sure that, as the ability to assess risk evolves as policies a nd practices change, all registered pesticides continue to meet that statutory standard. The public phase of regi stration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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Imidacloprid is systemic neonicotinoid nitr oguanidine insecticide used on food crops, ornamentals, turf, seed treatments, domestic pets, and structural pests. Imidacloprid’s mode of toxic action is the disruption of the nervous sy stem by acting as an in hibitor at nicotinic acetylcholine receptors. It was first registered for use in 1994, and as a result was not reviewed under the reregistration process.

Comments Received on Preliminary Work Plan:

The imidacloprid registration review docket r eceived more than 12,000 comments during the 90- day public comment period, which began on Decemb er 17, 2008. The Agency believes that the comments received do not change the data and risk assessment needs or the timeline detailed in the Imidacloprid PWP. An overview of comments is presented in the “Summary of Comments and Agency Responses” section of this document. A more detailed description of the comments received and the Agency’s response to these comments is available in the separate response memoranda from the Agency’s Environmental Fate and Effects Division (EFED), Health Effects Division (HED), and Special Review and Re registration Division (SRRD) located in the imidacloprid docket (EPA-HQ-OPP-2008-0844).

Risk Assessment and Data Needs:

Ecological Risk:

• The most recent risk assessment for all regi stered uses was conducted in October 2007. That assessment did not include a comple te endangered species determination for imidacloprid.

2 of 5• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination. The ecological risk a ssessment planned during registration review will allow the Agency to determine whether imidacloprid’s use has “no effect” or “may affect” federally listed threatened or e ndangered species (listed species) or their designated critical habitats. When an assessm ent concludes that a pesticide's use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the
U.S. Fish and Wildlife Service and/or Nationa l Marine Fisheries Service (the Services), as. Appropriate.

• Please refer to the November 13, 2008 document, EFED Preliminary Problem Formulation for the Registration Review of Imidacloprid in the registratio n review docket (Document ID EPA-HQ-OPP-2008-0844-003), fo r a detailed discussion of the anticipated ecological risk assessment needs.

• The Agency intends to issue a data call-in in early 2010 to require the following data on imidacloprid to complete these assessments:

o (GLN 835.4300) Aerobic aquatic so il metabolism study using TGAI imidacloprid.

o (GLN 850.3040) Field test for polli nators using TEP imidacloprid.

o (Special Study) Repeat dose field study for pollinators.

o (GLN 850.4100) Tier 1 seedling emer gence study (Tier 1) using TEP imidacloprid.

o (GLN 850.4150 ) Tier 1 vegetative vi gor study using TEP imidacloprid.

o (GLN 850.4400) Tier 1 aquatic plant gr owth study using TGAI imidacloprid.

o (Special Study) Seed leachi ng study using TEP imidacloprid.

Human Health Risk:

• The most recent risk assessment for all us es was conducted in May 2007, and reflects current registrations and uses of imidaclopr id, current FQPA policies, and addresses susceptibility of infants and children and aggregate exposures. Anticipated new toxicity and residential exposure data may require re visions to the dietary risk assessment and residential exposure assessment. A new occupational risk assessment and a companion animal risk assessment, which includes an an alysis of pet incidents, will be required to support registration review.

• Please refer to the December 3, 2008 document, Imidacloprid. Human Health Assessment Scoping Document in Support of Registration Review in the registration review docket (Document ID EPA-HQ-OPP-2008-0844-004), fo r a detailed discussion of the anticipated human health risk assessment needs.

• The Agency intends to issue a data call-in in early 2010 to require the following data to support registration review:

3 of 5o (GLN 870.7800) Immunotoxicity study using TGAI.

o (Special Study) Post-application wood wipe and leaching study

Timeline:

Activities Estimated Month/Year

Phase 1: Opening the Docket Open Public Comment Period for Imidacloprid Docket Completed 2008– Dec.

Close Public Comment Period Completed 2009– Mar. Phase 2: Case Development Final Work Plan (FWP) Completed 2009– Jun.

Issue DCI 2010– Jan.-Mar.

Data Submission 2012– Jan.-Mar. Preliminary Risk Assessment & Public Comment 2013– Jul.-Sep.

Close Public Comment Period 2013– Oct.-Dec. Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision 2014– Jan.-Mar.

Close Public Comment Period 2014– Apr.-Jun Final Decision and Begin Post-Decision Follow-up 2014– Jul-Sep.

Total 6 years

Summary of Comments Receive d During Docket Opening:

During the public comment period, the Agency received over 12,000 comments. The majority of
those comments were received as a result of a letter writing campaign organized by Natural Resources Defense Council (NRDC) voicing concer n that imidacloprid pr esents unacceptable risks to pollinators. The Agen cy received similar comments, i.e., concern over the risk to pollinators, from private citizens, honey beekeeper interests represented by the National Honey Bee Advisory Board (NHBAB), and environm ental advocacy groups like Beyond Pesticides, NRDC, and Sierra Club. Some commenters c ited open literature or provided anecdotal information on the effect of imidacloprid on bees. Other comments were received offering suggestions on how the Agency could collect data or manage the risk of imidacloprid to bees.
Few comments were received re garding the risks presented by imidacloprid either to wildlife species other than pollinators or to humans.

The Agency also received numerous comments in support of imidacloprid from growers; agricultural interest gr oups including the National Cotton Council, National Potato Council, National Sunflower Association, an d the Northwest Horticulture Council; residential pest control users; and academics. The technical registrant provided comments regarding the Agency’s risk assessment and on the anticipated data requireme nts discussed in the Imidacloprid Preliminary

Work Plan.

4 of 5Finally, in the Preliminary Work Plan, EPA solicited comments on three specific topics: environmental justice, water body impairment, a nd trade irritants. Du ring the comment period the Agency received one comment regarding water body impairments, one comment regarding trade irritants, and no comments re garding environmental justice.

Comments relevant to human health have b een addressed by the Health Effects Division’s document, Response to Comments on Human-Health Assessment Scoping Document in Support of Registration Review (dated May 5, 2009). Comments regard ing the ecological fate or effects of imidacloprid have been addressed by the Environmental Fate and Effects Division’s document, Imidacloprid: EFED Response to Co mments on Registration Review PWP (dated June 27, 2009). Comments regarding policy and pro cess have been addressed in Special Review and Reregistration Division’s document, Imidacloprid: SRRD Response to Comments on Registration Review PWP (Dated June 30, 2009). All three documents are available in the docket (EPA-HQ-OPP-2008-0844).

Next Steps

The Agency plans to develop a Data Call-In Noti ce for this pesticide and expects to issue it in January, 2010.

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