Docket Number EPA-HQ-OPP-2010-0422 www.regulations.gov

Fenpropathrin Summary Document Registration Review: Initial Docket

June 20103 TABLE OF CONTENTS

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I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 12

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. EFED Registration Review Problem Formulation for Fenpropathrin . USEPA, June 16, 2010.

2. Fenpropathrin

. Human Health Assessment Scoping Document in Support of Registration

Review . USEPA, April 27, 2010.

3. Fenpropathrin- ADDENDUM to D371484 Hum an Health Assessment Scoping Document in Support of Registration Review . USEPA, June 10, 2010.

4. PRD Appendix A: Food/Feed & Non-Food/Non- Feed Uses Considered in Registration Review Work Planning – Fenpropathrin (127901) . USEPA, June 2, 2009.

5. Screening Level Estimates of Agricu ltural Uses of Fenpropathrin (127901). USEPA, August 7, 2009.

6. Fenpropathrin Review of Human Incidents . USEPA, February 25, 2010.

All supporting documents for the registration review of Fenpropathrin are located in docket EPAHQ-OPP-2010-0422 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Fenpropathrin

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registrati on review program. All pesticides distributed or sold in the United St ates (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency ), based on scientific data showing that they

will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration re view program is intended to make sure that, as the ability to assess risk evolves and as policies an d practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use prac tices will occur over time. Through the registration review program, the Agency periodi cally reevaluates pesticides to ma ke sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state whatit knows about the pesticide and what additional risk analyses and data or information it believes ar e needed to make a regist ration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of fenpropathrin.

Fenpropathrin is a type II pyrethroid inse cticide and acaracide registered for use on ornamentals and agricultural crops , which include apples, cantaloupes , grapefruit, grapes, oranges, pears, peppers, strawberries and tomatoes. Si nce fenpropathrin was first registered in 1989, it was not subject to a Reregistration Eligibility Decisi on (RED). In 1997, EPA assessed tolerances of fenpropathrin consistent with FQPA (62 Fed. Reg. 63,029, November 26, 1997).

Below is a summary of the issues relevant to the registration review of fenpropathrin and the data the Agency anticipates needing.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting a comprehens ive ecological risk a ssessment, including an endangered species risk assessment, for all uses of fenpropathrin. The Agency also anticipates conducting an occupational human exposure risk asse ssment. Further human health risk assessments may be needed if the Agency determines that there is residential bysta nder exposure or revises fenpropathrin’s endpoints of toxicological concern.5 Ecological Risk

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

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination. The ecological risk assessment planned during registration review will allow the Agency to determine whether fe nopropathrin’s use has “no effect” or “may affect” federally listed threatened or endangere d species (listed species) or their designated

critical habitats. When an assessment conclude s that a pesticide’s use “may affect” a listed species or its designated critical habitat, th e Agency will consult with the U.S. Fish and

Wildlife Service and/or National Marine Fisher ies Service (the Servic es), as appropriate.

• The Agency anticipates needing the following da ta in order to conduct a complete ecological risk assessment, including an endanger ed 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)

1 Registrants may opt to conduct a Tier I study. However, 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.6 • For a more detailed discussion of the anticipated ecological ri sk assessment and data needs, please refer to the EFED Registration Review Problem Formulation for Fenpropathrin , dated June 16, 2010. This document is located in the docket.

Human 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 abbreviated a ssessment 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 additional experimentation, spec ific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evalua te the potential for increased susceptibility of young organisms. A meeting of the FIFRA Scientific Advisory Panel (SAP) is planned for July 2010. 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 imm unotoxic 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 reproduction and developmental neurotoxicity (DNT) data for fenpropathrin, is currently 1X. However, 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 a dult animals to pyrethroids. Therefore, the Agency is investigating the need for additi onal experimentation, specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evalua te the potential for increased susceptibility of young organisms. The FQPA safety factor will be re-evaluated 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 dur ing registration review to ensure that it appropriately c overs the metabolites and degradat es of fenpropathrin and that it specifies the residues to be measured for each commodity.

• In the 2008 risk assessment, dietary risk esti mates (food and water) were below the Agency’s level of concern. Therefore, the Agency doe s not anticipate conducting a new dietary risk assessment unless endpoints and safety factors for fenpropathrin are revised.7 • Fenpropathrin has no residential uses. However, residential exposure could potentially result from the volatilization and transport of fenpr opathrin from treated areas. The Agency will

evaluate the need for a reside ntial bystander inhalation risk assessment during registration review. The Agency is in the process of ev aluating whether new polic ies or procedures are necessary to identify when and how to inco rporate residential inha lation exposure in the Agency’s risk assessments. If new policies or procedures are deve loped, the Agency may decide to conduct a bystander inhalation risk assessment.

• 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 nurseries 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 Pe sticide Handler’s Exposur e Data (PHED) and/or Outdoor Residential Exposure Task Force (ORETF ) 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 post-applic ation inhalation exposure in th e Agency’s occupational risk assessments. If new policies or procedures ar e developed, the Agency may decide to conduct an occupational post-application risk a ssessment for all relevant scenarios.

• Fenpropathrin belongs to the pyr ethroid class of insecticides . This class also includes permethrin, cypermethrin, cyfluthrin, deltame thrin, tau-fluvalinate, and lambda-cyhalothrin, among others. EPA developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and syntheti c pyrethroids (Proposed common mechanism grouping for the pyrethr ins and pyrethroids, draft, May 19, 2009
http://www.regulations.gov/search/Regs/hom e.html#documentDet ail?R=09000064809a62df ) . This document was supported by the FIFRA SAP and is available in the docket. See http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a1f8d7

. EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comm ents. Pesticides with a comm on mechanism of toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going by EPA’s Office of Research and Developm ent (ORD) to make improvements to the Stochastic Human Exposure and Dose Simulation (SHEDS) probabilis tic exposure model, which are important

for the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokinetic models for several pyrethroids . The status of both of these research modeling efforts will be reviewed by the FIFRA SAP in July, 2010. For information regarding EPA’s efforts to evaluate the risk to pyrethroids. See http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html.8 • The Agency anticipates requiring the following data in order to conduct a complete human health risk assessment 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 Scopi ng 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 Require ments) for registration of a pesticide (food and non-food uses). The Agency anticipates requ iring this study to obt ain basic information about the compound’s identity/composition and th e 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 ce rtain substances (incl uding pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effects as th e Administrator may designate.” The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the poten tial of a chemical substance to interact with the estrogen, androge n, or thyroid (E, A, or T) horm onal systems. Chemicals that go through Tier 1 screening and are foun d to have the potential to inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine related effects caused by the subs tance, and establish a quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide ac tive ingredients and 9 iner t ingredients. This

list of chemicals was selected based on the potential fo r human exposure through pathways such as food and water, residential activity, and certain po st-application agri cultural scenarios. This list

should not be construed as a list of known or likely endocrine disruptors.

Fenpropathrin is not among the group of 58 pesticid e active ingredients on the initial list to

be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide9 chemicals. Accordingly, EPA anticipates i ssuing future EDSP orders/data call-ins for all Registration Review cases, including those for whic h EPA has 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, pleas e visit our website: http://www.epa.gov/endo/

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Timeline

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 – 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 Regist ration 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.

Guidance for Commenters

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consider all comments, as well as any additional information or data provided in a timely manner, prior to issu ing a final work plan for the fenpropathrin case.

Trade Irritants

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum10 Residue Limits (MRLs) or dispar ities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possibl e regarding the natu re of the concern.

Environmental Justice

EPA seeks to achieve environmen tal justice, the fair treatmen t and meaningful involvement of all people, regardless of race, color, nati onal origin, or income, in the development, implementation, and enforcement of environmental la ws, regulations, and policie s. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to fenpropath rin compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure, compared to the general population.

Water Quality

Fenpropathrin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=885

. However, the pyrethroids as a group have been iden tified as a cause for impairment for three water bodies in Central Valley, CA: Del Puerto Creek, I ngram Creek Site (confluence with Hospital Creek to Hwy 33 crossing) and second Ingram Creek Site (confluence with San Joaquin River to confluence with Hospital Creek). Nonetheless, no Total Maximum Daily Loads (TMDL) have been developed for fenpropathrin, base d on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_na tion.tmdl_pollutant_deta il?p_pollutant_group_id=88 5&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possi ble, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: In clusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registration R eview Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/registra tion_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.11 Additional Information

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining risk assessments, includ ing any species-specific ecological effects determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information.

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates

e. frequency of application, a pplication intervals, and maxi mum number of applications per season and per year

f. geographic limitations on use

2. Use or potential use distribu tion (e.g., geographical distri bution of relevant uses).

3. Use history.

4. Median and 90 th percentile reported use rates (lb/A, lb 1K sq.ft) from usage data – national, state and county.

5. Application timing (date of firs t application and application intervals) by use – national, state, and county.

6. Usage/use information for non-agricultural uses.

7. Directly acquired county-level usage data (not derived from state level data).

a. maximum reported use rate (lb/ A) from usage data – county

b. median and 90 th percentile number of applications – county

c. total pounds per year – county

d. the year the pesticide was last us ed in the county/sub-county area

e. the years in which the pesticide was applied in the county/sub-county area

8. Typical application interval (days).

9. State or local use restrictions.

10. Ecological incidents specific to fenpropathrin (non-target plant damage and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or beneficial inse ct mortalities) not already reported to the Agency.

11. Monitoring data.

12. Any adverse effects in honey bees or other be neficial insects associated with the use of fenpropathrin products.

Next Steps

After the 60-day comment period closes, th e Agency will review and respond to any comments received in a timely manner and then expect s to issue a Final Work Plan in November of 2010 for fenpropathrin.12 II. FACT SHEET

Background Information

• Fenpropathrin registration review case number: 7601

• Fenpropathrin PC Code: 127901; CAS # 39515-41-8

• Fenpropathrin was first registered in the United States in 1989.

• Technical registrant: Vale nt U.S.A. Corporation

• There are 8 FIFRA Section 3 ac tive product registrati ons, which includes one technical use registration.

• Pesticide Re-evaluation Division Contact: Avivah Jakob (Jakob.kathryn@epa.gov)

• Registration Division Co ntact: Olga Odiott ( Odiott.olga@epa.gov ).

Use and Usage Information

For additional usage informa tion and use details refer to Food/Feed & Non-Food/Non-Feed Uses Considered in Registration Revi ew Work Planning – Fenpropathrin (127901) , dated June 2, 2009, which can be located in the fenpropathrin docket.

• Fenpropathrin is a pyrethroid insecticide regi stered for use on ornamentals and on a variety of agricultural uses including apples, cantaloupes, grapefruit, gr apes, oranges, pears, peppers, strawberries and tomatoes.

• The largest agricultural uses of fenpropathrin are strawberries, or anges, pears and grapefruit. The Agency estimates that the maximum percent crop treated of these commodities are respectively 50%, 30%, 20% and 20%.

• Fenpropathrin is registered for use to contro l a variety of arthropods including aphids, worms, moths, beetles, mites, spiders, thrips, flies, fleas and other pe sts in agricultural and ornamental plant situations.

• Fenpropathrin is formulated as an emulsifi able concentrate and a pressurized liquid.

• Fenpropathrin can be applied by aircraft, airb last ground sprayer, broadcast ground sprayer

and aerosol can.

Pending and Recent Actions

• The Agency is currently reviewing the proposed new use of fenpropathrin on tropical fruits. The Agency anticipates making its re gistration decision in November 2010.

• In March 2009, the Agency esta blished tolerances for residu es of fenpropathrin in or on almond hulls, sweet cherry, tart cherry, stone fr uits (crop group 12 – ex cept cherries), tree nuts (crop group 14), pistachio, avocado, black sapote, canistel, mamey, sapote, mango, papaya, sapodilla, star appl e, caneberry and olive.13 Ecological Risk Assessment Status

The primary environmental concerns identified in previous risk assessments were chronic risk to birds and mammals, and acute and chronic ri sk to fish, aquatic inve rtebrates including benthic organisms, reptiles, and terrestrial and aquatic phase amphibians. Fenpropathrin is also toxic to honeybees; therefore, risk to be neficial insects was assumed.

For a detailed discussion of previous ecological risk asse ssments, please refer to the EFED Registration Review Problem Formulation for Fenpropathrin , dated June 16, 2010. This document

is located in the docket.

Human Health Risk Assessment Status

The following are key findings of the human he alth risk assessments conducted to support fenpropathrin registered uses. For a detailed discussion of the human health risk assessment status, please refer to the Fenpropathrin. Human Health Assessm ent Scoping Document in Support of Registration Review, dated April 27, 2010 and the Fenpropathrin- ADDENDUM to D371484 Human Health Assessment Scoping Docu ment in Support of Registration Review , dated June 10,

2010. These documents are located in the docket.

Hazard Characterization

• Fenpropathrin exhibits high acute toxicity throu gh the oral and dermal routes of exposure. Fenpropathrin is a mild eye irrita nt, non-irritating to the skin a nd is not a skin sensitizer. Because of fenpropathrin’s low-vapor pressure, the methods used in previous inhalation studies did not generate inha lation exposures high enough to elicit a toxic response. Therefore, acute inhalation toxicity has not been determined for fenpropathrin.

• Fenpropathrin is classified as “not likely to be carcinogenic to humans” based on carcinogenicity studies in rats and mice.

• In the prenatal developmental studies in rats and rabbits, th e reproduction study in the rat and the developmental neurotoxicity (DNT) st udy, fenpropathrin had no adverse effects on offspring in the absence of maternal effects. Because there was no evidence of increased susceptibility in fetuses following in utero exposure as compared to maternal animals and no concerns regarding exposure estimates unde restimating actual exposures, in the 2008 assessment the Agency reduced the FQPA Safety Factor to 1X. However, 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 comp aring the sensitivity of young and adult animals to pyrethroids. The Agency is investigating th e need for additional experimentation, specific to the mode of action and pharmacokinetic char acteristics of pyrethroi ds, to evaluate the potential for increased susceptibility of young organisms.14 Dietary Risk

• In EPA’s 2008 risk assessment, dietary risk (f ood and water) estimates from all registered fenpropathrin uses were below the Agency’s level of concern.

Residential and Recreational Risk

• There are no registered residen tial uses of fenpropathrin; ther efore, residential exposure has not been previously assessed.

Aggregate Risk

• A residential exposure assessment has not been previously conducted because it is believed that fenpropathrin use does not result in resi dential exposure. Ther efore, aggregate risk estimates are equivalent to the diet ary risk estimates described above.

Occupational Risk

• Past fenpropathrin risk assessments rely in pa rt on data from studies in which adult human subjects were intentionally exposed to a pest icide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handler s Exposure Database (PHED) and the Agricultural Reentry Task Fo rce (ARTF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the

research was conducted. All a pplicable requirements of EPA’ s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) ha ve been satisfied and there is no regulatory

barrier for continued reliance on these studies.

• All occupational exposures resulting from fenprop athrin use have been previously evaluated. The results of previous occupa tional handler exposure assessme nts showed no risk estimates

of concern.

Cumulative Assessment

• Fenpropathrin is a member of the pyrethroid clas s of insecticides. This class also includes permethrin, cypermethrin, cyfl uthrin, tau-fluvalinate, bifent hrin, and lambda-cyhalothrin, among others. EPA developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurr ing pyrethrins and s ynthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and pyrethroids, draft, May 19, 2009; http://www.regulations.gov/search/Reg s/home.html#documentDetail?R=09000064809a15 62df ). This document was supported by the FI FRA Scientific Advisory Panel (SAP) and EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comm ents. Pesticides with a comm on mechanism of toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going by EPA’s Office of Research and Developm ent (ORD) to make improvements to the Stochastic Human Exposure and Dose Simulation (SHEDS) probabilistic exposure model which is important

for the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokinetic models for several pyrethroids . The status of both of these research modeling efforts will be reviewed by the FIFRA SAP in July, 2010. For information regarding EPA’s efforts to evaluate the risk to pyrethroids, http://www.epa.gov/pesticides/cumulative/

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Incidents

• A preliminary review of the Ec ological Incident Informati on System (EIIS) and the Avian
Incident Monitoring System (AIMS) Database identified one incide nt for fenpropathrin.
Fenpropathrin was classified as a “highly pr obable” cause for an incident in 1996 involving
hundreds of fish mortalities (shad, catfish and ca rp) after fenpropathrin application to cotton.

• An updated review of fenpropathrin human inci dent reports was prepared by consulting the OPP Incident Data System (IDS) and the Ce nters for Disease Control and Prevention/ National Institute for Occupational Safety and H ealth Sentinel Event Notification System for Occupational Risk-Pesticides. In the United States, from 2002 to the present, 12 incidents were reported for fenpropathrin. Of those 12 re ported incidents, onl y six incidents were identified as definitely, probably or possibly caused by fenpropa thrin exposure. Three of the six incidents were related to occupational pest icide application while the other three did not involve pesticide application (f urther details are unknown). Th e health effects identified include dermal, neurological a nd ocular. Based on the low se verity and low number of incident cases, there does not appear to be a c oncern at this time that would warrant further investigation.

Tolerances and International Harmonization

• Tolerances are established under 40 CFR 180.466 for residues of fenpropathrin that result from agricultural uses. Tolerances are esta blished in terms of fenpropathrin. There are no Canada maximum residue limits (MRL) for fe npropathrin. Codex MRLs are not harmonized with U.S. tolerances for cattle (meat and meat byproducts), eggs, milk, poultry (meat and meat byproducts), eggplants, dry chili peppers, gh erkin, and tea (green an d black). Some of

the U.S. tolerances that are not harmonized with Codex MRLs may also not be harmonized

with Mexico MRLs because Mexico either a dopts US tolerances or Codex MRLs for import

purposes.16 Data Call-In Status

• No data call-ins (DCIs) have been issued for fenpropathrin.

Labels

• Active Section 3 labels for fenpropathrin can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

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