Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of fenpropathrin. 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 fenpropathrin registration review docket (E PA-HQ-OPP-2010-0422) 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/

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Fenpropathrin is a type II pyrethroid inse cticide and acaracide registered for use on ornamentals and agricultural crops, which incl ude apples, cantaloupes , grapefruit, grapes, oranges, pears, peppers, strawberries and tomato es. Since fenpropathrin wa s first registered in 1989, it was not subject to a Reregistration Eligib ility Decision (RED). In 1997, EPA assessed tolerances of fenpropathrin consistent with FQPA (62 Fed. Reg. 63,029, November 26, 1997).

This document makes final the work plan for the fenpropathrin registration review.

Comments Received on Preliminary Work Plan

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

Work Plan document can be located in the fe npropathrin registration review docket (EPA-HQOPP-2010-0422) at www.regulations.gov

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During the public comment period the Agency received several comments as described and discussed below from Valent USA, the P hysicians Committee for Responsible Medicine (PCRM) and the FIFRA Endangered Species Task Force (FESTF).

Page 2 of 9Valent Comment : In Table 3.4 – Screening-Level Estim ates of Agricultural Uses of Fenpropathrin, Valent would like to identify some changes to the pounds of AI used for some crops and the Percent Crop Treated.
Percent Crop Treated Crop Lb. A.I. Avg. Max. Reason for Change Apples* 10,000 5% Decline due to MRL Challenges Grapes* 6,000 1% 10% Decline due to MRL Challenges
and new products Oranges* 50,000 30% 50% Increase due to use for Asian Citrus Pysllid, spread of greening
Cotton* ≤ 1,000 ≤ 1% 5% Decline due to acreage shift and other pest

control tools. *Numbers based on 2009 GfK a market research.company report.

EPA Response : The Agency thanks Valent for its comment and will consider this information as it conducts the registration review and makes its registration review

decisions.

Valent Comment : In the SRRD Appendix A: Food/F eed and Non-Food/Non-Feed Uses Considered in Registration Review Work Pl anning, Valent USA woul d like to correct the following numbers in the chart.

For Loquat the Max App Rate should be 0.8006 lb/cc For Pear the Max App Ra te should be 0.8006 lb/cc For Strawberry the Max App Rate sh ould be 0.8006 lb/cc. Also the Max # Apps/CC or Yr for Strawberry should be 2 instead of 1.

EPA Response : The Agency thanks Valent for their comment and upon review, has

found that Valent was correct in that there were inaccuracies in the Appendix A. In response the Agency has corrected the Appe ndix A accordingly to reflect the accurate maximum application rates for loquat, pear and strawberry, and to reflect the correct maximum number of apps/CC or year for strawberry.

FESTF Comment : The FIFRA Endangered Species Task Force (FESTF) commented that the technical registrant for fenpropathrin (Valent USA Co rporation) is a member of the FESTF and is entitled to rely on FESTF data. In their comment, FESTF also noted that they are making every effort to inform registrants who are not currently eligible to rely on FESFT data of the role of FESTF data in listed species assessments and various options for reliance on that data.

Page 3 of 9EPA Response : The Agency thanks FESTF for its comment and will consider this information as it conducts the registration review and makes its registration review

decisions.

Valent USA and PCRM also submitted seve ral comments on the technical information presented in the Registration Review – Preliminary Probl em Formulation for Ecological Risk and Environmental Fate, Endangered Species , and Drinking Water Assessments for Fenpropathrin document, dated February 5, 2010. A detailed description of the technical comments received and the Agency’s response to these comments is available in a separate response memoranda entitled Response to Comments on the Regi stration Review- Environmental Fate and Ecological Risk Assessment Problem Fo rmulation in Support of Registration Review for Fenpropathrin (October 20, 2010) which can be locate d in the fenpropathrin registration review docket (EPA-HQ-OPP-2010-0422) at www.regulations.gov

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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 environmen tal justice or water body impairments. However, the technical registra nt, Valent USA, provided the following comment relevant to trade irritant issues resulting fr om the lack of Maximum Residue Limits (MRLs) and disparities between the U.S. Tolerances and MRLs in key export markets:

Valent Comment : Valent USA would like to take th is opportunity to comment on the issues fenpropathrin is facing with disparities in the MRLs between c ountries. In the EU the lack of MRLs for certain crops is largel y driven by different risk characterization leading to a different acute diet ary toxicity endpoint than in the U.S. As a result we have had rejection of apples with lega l residues. This difference has resulted in a gap between U.S. tolerance and EU MRL creating free export into the EU a challe nge for apple, grape and other fruit commodity groups. In addition, Canada, Taiwan and Japan are also critical markets for the special ty markets fenpropathrin is re gistered for use and face the same issues. An example of this is that earl ier this year a shipment of cherries with legal fenpropathrin residues was seized in Taiwan, and testing of cherries has been increased

in Taiwan and South Korea.

EPA Response : The Agency thanks the registrant for their comment and will consider

this information when conduc ting the risk assessments.

The comments received during the comment pe riod do not change the anticipated data

and risk assessment needs or the time line detailed in the fenpropathrin PWP.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting a comp rehensive ecological risk assessment, including an endangered species risk assessment, for all uses of fenpropathrin. The Agency also anticipates conducting an occupational human expos ure risk assessment. Further human health risk assessments may be needed if the Agency determines that there is residential bystander exposure or revises fenpropathrin’s e ndpoints of toxicological concern.

Page 4 of 9Ecological Risk

• The most recent ecological risk assessment was completed in 2008 to support the new uses of fenpropathrin on bushberries, can eberries, olives, currants, peas, fruiting vegetables, stone fruits, tree nuts, pistachios, certain trop ical fruits and barley.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for fenpropathrin. Th e ecological risk asse ssment planned during registration review will allow the Agency to determine whether fenpropathrin’s use has “no effect” or “may affect” federally liste d threatened or endangered species (listed species) or their designated critical habita ts. 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.

• The Agency anticipates needing the followi ng data in order to conduct a complete ecological risk assessment, including an endangered species assessment for fenpropathrin:

o GDLN 835.1230 or 825.1240 – Leaching and adsorption/desorption

o GDLN 835.2240 – Photodegradation in Water

o GDLN 835.4100 – Aerobic Soil Metabolism

o GDLN 835.4200 – Anaerobic Soil Metabolism

o GDLN 835.4300 – Aerobic Aquatic Metabolism

o GDLN 835.4400 – Anaerobic Aquatic Metabolism

o GDLN 835.6100 (footnote 7) – Environm ental Chemistry Methods – soil

o GDLN 835.6200 (footnote 7) – Environmenta l Chemistry Methods – water and

sediment

o GDLN 850.1010 Aquatic Inverteb rate Acute Toxicity ( Hyalella azteca)

o GDLN 850.1400 – Fish Early-Life Stage (estuarine/marine)

o GDLN 850.2100 –Avian Oral Toxicity (passerine species)

o GDLN 850.4100 – Seedling Emergence (Tier II) 1

o GDLN 850.4150 – Vegetative Vigor (Tier II) 1

o GDLN 850.4400 – Aquatic Vascular Plant Growth ( Lemna spp

. ) (Tier II) 1

o GDLN 850.5400 – Algal Toxicity Test (Tier II) 1

o Non-GDLN – Whole Sediment: Chroni c Invertebrates (freshwater and estuarine/marine) ( Hyalella azteca

, Chironomus dilutus, and Leptocheirus plumulosus) (Special Study)

• For a more detailed discussion of the antic ipated ecological risk assessment and data needs, please refer to the EFED Registration Review Problem Formulation for Fenpropathrin , dated June 16, 2010. This docum ent is located in the docket.

1 Registrants may opt to conduct a Tier I study. Howe ver, any adverse effects (even if <25%) identified will necessitate a Tier II study. A Tier II study will enable the Agency to conduct an endangered species assessment for non-target plants.

Page 5 of 9Human Health Risk

• The most recent comprehensive human health risk assessment for fenpropathrin was completed in 2008 to support the new uses of fenpropathrin on bushberries, caneberries, olives, currant, peas, fruiting ve getables, stone fruits, tree nuts , pistachios, certain tropical fruits and barley. In 2009, an abbreviate d assessment was completed to evaluate a proposed low-volume use on citrus as a special local need in Florida.

• The Agency is investigating the need for add itional experimentation, sp ecific to the mode of action and pharmacokinetic characteristics of pyrethroids, to eval uate the potential for increased susceptibility of young organisms. For more information on the pyrethroid developmental neurotoxicity (DNT) requirement, see http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html

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• The toxicology database is incomplete with a data gap for immunotoxic effects (a new requirement for Part 158) and an outstandi ng 90-day inhalation study. The FQPA safety factor, which is based on the rat reproduc tion and developmental neurotoxicity (DNT) data for fenpropathrin, is currently 1X. Ho wever, based on the Agency’s review of existing pyrethroid data, EPA has come to the conclusion that the DNT is not a particularly sensitive study for comparing the sensitivity of young and adult animals to pyrethroids. Therefore, the Agency is investigating the need for additional experimentation, specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evaluate the potential for increased suscep tibility of young organisms. The FQPA safety factor will be re-eva luated for fenpropathrin following a final determination of the potential for increased susceptibility of infants and children to pyrethroid pesticides based on the results of all available data, including those human health data identified within this Preliminary Work Plan as anticipated as being needed.

• The existing residue chemistry database for fenpropathrin is adequate for risk assessment

purposes.

• The tolerance expression in 40 CFR 180.466 will be reviewed during registration review to ensure that it appropriately covers the me tabolites and degradates of fenpropathrin and that it specifies the residues to be measured for each commodity.

• In the 2008 risk assessment, dietary risk estimates (food and water) were below the Agency’s level of concern. Therefore, th e Agency does not anticipate conducting a new dietary risk assessment unless endpoints and safety factors for fenpropathrin are revised.

• Fenpropathrin has no residential uses. Howe ver, residential exposure could potentially

result from the volatilizati on and transport of fenpropathri n from treated areas. The Agency will evaluate the need for a resi dential bystander inha lation risk assessment during registration review. The Agency is in the process of evaluating whether new policies or procedures are necessary to identify when and how to incorporate residential inhalation exposure in the Agency ’s risk assessments. If ne w policies or procedures are developed, the Agency may decide to conduct a bystander inhalation risk assessment.

Page 6 of 9• The Agency does not anticipate conducting an aggregate assessment for fenpropathrin in registration review unless diet ary endpoints and safety fact ors are revised and/or new

inhalation risks to re sidential bystanders need to be assessed.

• All occupational exposure scenar ios have been assessed for fe npropathrin. However, the Agency anticipates reassessing occupational handler and post-application exposures for the use of fenpropathrin on ornamental plants in commercial nurs eries and greenhouses. The ornamental plant uses were last assessed in 1993, and it is anticipated that these uses will need to be reassessed using currently available Pesticide Handler’s Exposure Data (PHED) and/or Outdoor Reside ntial Exposure Task Force (OR ETF) data. In addition, the Agency is in the process of evaluating whether new policies or procedures are necessary to identify when and how to incorporate pos t-application inhalation exposure in the Agency’s occupational risk assessments. If new policies or procedures are developed, the Agency may decide to conduct an occupational post-application risk assessment for all

relevant scenarios.

• Fenpropathrin belongs to the pyr ethroid class of insecticides . This class also includes bifenthrin, cyfluthrin, cyperm ethrin, deltamethrin, lambda -cyhalothrin, permethrin, and tau-fluvalinate, among others. EPA has deve loped a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids, which was supported by the FIFRA Scientific Advisory Panel (SAP). Upon finalization of this science policy, the pyrethroids will be subject to a cumulative risk assessment under the FQPA.

• The Agency anticipates requiring the followi ng data in order to conduct a complete

human health risk assess ment for fenpropathrin:

o GDLN 870.7800 – Immunotoxicity Study

o GDLN 870.3465 – 90-Day Inhalation Study

• For a detailed discussion of th e anticipated human health risk assessment and data needs for fenpropathrin refer to the Fenpropathrin. Human Health Assessment Scoping Document in Support of Registration Review

, dated April 27, 2010 and the Fenpropathrin- ADDENDUM to D371484 Human Health Assessment Scoping Document in Support of Registration Review , dated June 10, 2010. These documents are located in

the docket.

Other Anticipated Data Needs:

• GLDN 830.7050 UV/Visible Li ght Absorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requirements) for registration of a pesticide (food and non-food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s id entity/composition and the wavelengths at which the compound may be suscepti ble to photochemical degradation.

Page 7 of 9Endocrine 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 may designate.” The EDSP employs a two-tiered ap proach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 screening 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. This list should not be construed as a list of known or likely endocrine disruptors.

Fenpropathrin is not among the group of 58 pestic ide 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 i ssuing future EDSP orders/data call-ins for all Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pestic ide 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/

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Page 8 of 9Timeline

The Agency has created the following estimated timeline for the completion of the fenpropathrin registration review.

Registration Review for Fenpropathrin Projected Registrati on 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 – December

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 a nd Begin Post-Decision Follow-up 2016 Total (years) 1 6
1 An assessment of the potential cumulative risk from the pyrethroid class of insecticides may impact this time

estimate.

Next Steps

The Agency plans to issue a Data Call-In (D CI) for fenpropathrin in 2011. The new data

will be used to conduct the risk assessments ou tlined in this FWP for all fenpropathrin uses.

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