Docket Number: EPA-HQ-OPP-2010-0915 www.regulations.gov



## Tau-fluvalinate Summary Document

Registration Review: Initial Docket

December 201023 

### TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 11

III. Summary of Data Gaps 16

______________________ __________________

Please Note

This document summarizes the Environmental Protection Agency's current position on taufluvalinate based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, and Endangered Species A ssessments for Tau-fluvalinate. December 15, 2010.

2. Tau-fluvalinate. Human Health Assessm ent Scoping Document in Support of Registration Review. November 8, 2010.

3. Tau-fluvalinate Reregistration Eligibility Decision. September 2005. (Available from http://www.epa.gov/oppsrrd1/ REDs/taufluvalinate_red.pdf )

4. Updated Review of Tau-fluvalinate Incident Reports. August 19, 2010.

5. Screening Level Use Analysis (SLUA) for Tau-fluvalinate. January 21, 2010.

6. Appendix A for Tau-fluvalinate. January 13, 2010.

Additional supporting documents for tau-fluvalin ate may be found in the docket located on the

internet at www.regulations.gov

.4 I. Preliminary Work Plan – Tau-fluvalinate

Introduction:

The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program. All pesticides sold or distributed in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and 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 practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www. epa.gov/oppsrrd1/registration_review/.

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 belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of tau-fluvalinate.

Tau-fluvalinate is a broad-spectrum insecticide/mitici de in the pyrethroid cla ss of pesticides. It is registered for a single food use (beehive s/honey) and several non- food uses, including ornamentals (outdoor and containe r-grown, greenhouse, interior plan tscapes, dip for cuttings), building surfaces/perimeters, ant mounds and certa in crops (carrots and brassica/cole crops) grown for seed. It is registered for use on resi dential outdoor sites such as ornamental plants, ground cover, and shrubs. Tau-fluvalinate was first re gistered in one of its earlier forms, racemic fluvalinate, in 1983. Tau-fluvalinate was the subj ect of a Reregistrati on Eligibility Decision (RED), which was completed on September 28, 2005.

Anticipated Risk Assessment and Data Needs:

The Agency intends to require data needed to update and revise the eco logical risk assessment for tau-fluvalinate (including an endangered species risk assessment). The Agency also intends to require data needed to update and revise the human health risk assessment. Below is a summary of the issues relevant to the registra tion review of tau-fluva linate and the data the Agency plans to require.5 Ecological Risk:

• The most recent ecological risk assessment was completed in 2005 to support the taufluvalinate RED.

• 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 use of tau-fluvalinate has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an asse ssment 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 National Marine Fisheries Services (the Services), as appropriate.

• An updated ecological assessment is planned to be conducted to incorporate new data and any relevant changes to risk assessment methodologies.

• The Agency intends to require the followi ng data in order to conduct a complete ecological risk assessment, including an e ndangered species assessment, for all uses:

o Guideline (GLN) 850.4100 – Seedling emergence Tier II 1

o GLN 850.4150 – Vegetative vigor, Tier II 1

o GLN 850.4400 – Aquatic plant growth (v ascular plant toxicity), Tier II 1

o GLN 850.5400 – Aquatic plant growth (a lgal plant toxicity), Tier II 1

o GLN 835.4300 – Aerobic aquatic metabolism

o GLN 834.4400 – Anaerobic aquatic metabolism

o GLN 835.6100 – Terrestrial field dissipation

o GLN 850.1025 – Acute toxicity to estuarine/ marine invertebrate for the oyster

o GLN 850.1350 – Aquatic invertebrate life-cycle for mysid shrimp

o GLN 850.2100 – Avian oral toxicity test for passerine species

1 The Agency anticipates requiring a Tier II study. A Ti er I study may be conducted in lieu of a Tier II study with the understanding that adverse effects (even if <25%) would necessitate a Tier II study as well. The purpose of a Tier II study is to establish eith er a No Observed Adverse Effect Concentration (NOAEC) or a concentration at which there is a 5% ob served effect (EC05) to be used in an endangered species risk assessment for nontarget plants. If neither an NOAEC nor an EC05 value is available, then the Agency may have to presume that tau-fluvalinat e "may affect" listed nontarget plant species in the registration review endangered species risk assessment.6 o Non-guideline – Test for Measuring th e Effects of Sediment Associated Contaminants on Survival, Growth, and Reproduction on Hyalella azteca in USEPA 2000 Methods for Measuring the Toxicity and Bioaccumulation of

Sediment-associated Contaminants with Freshwater Invertebrates (EPA 600/R99/064).

o Non-guideline – Life-cycle Test for Measur ing the Effects of Sediment-associated

Contaminants on Chironomus dilutus or C. tentans in USEPA 2000 Methods for Measuring the Toxicity and Bioaccu mulation of Sediment-associated

Contaminants with Freshwater Invertebrates (EPA 600/R-99/064).

o Non-guideline – Leptocheirus plumulosus in USEPA 2001 Method for Assessing the Chronic Toxicity of Marine and Estu arine Sediment-associated Contaminants with the Amphipod Leptocheirus plumulosus (EPA 600/R-01/020).

• Please refer to the Registration Review: Prelimin ary Problem Formulation for Environmental Fate, Ecological Risk, and Endangered Species Assessments for Taufluvalinate located in the docket, for a detaile d discussion of the anticipated risk

assessment needs.

Human Health Risk:

• The most recent comprehensive human health assessment was completed in September 2005 in support of the tau-fluvalinate RED. Su bsequent to the last risk assessment, the Agency has identified age-dependent pharm acokinetic factors associated with all pyrethroid insecticides that may lead to un certainty regarding effects in children.

• Tau-fluvalinate residential use was restrict ed to commercial applicators in 2005. Therefore, a residential handl er (homeowner) assessment wa s not conducted. However, since the 2005 assessment, two new homeowner end-use products have been registered for use on outdoor residential areas. During registration review, th e Agency plans to assess potential residential ha ndler exposure. A post-appli cation exposure assessment of

the current residential uses of tau-fluvalin ate is not necessary as it is the Agency’s standard practice not to assess post-applic ation residential expos ures from treated ornamentals or from perimeter, spot, and crack and crevice treatments to patios and other

outside surfaces.

• During registration review, a new drinking wa ter assessment will likely be conducted to take into account any new, relevant data s ubmitted to the Agency or published in the literature. Input parameters to the drinki ng water model will also be updated to reflect current input parameter guidance.

• During registration review, the Agency fores ees conducting a full reassessment of dietary (food and water), occupational, residential, and aggregate risk, ta king into account any changes to toxicological endpoints, safety factors, exposure values, and applicable standard operating procedures.7 • The Agency is in the process of examining its policies and processes regarding inhalation risk assessment and anticipates evaluating the need for a bystander inhalation risk

assessment for tau-fluvalinate reside ntial use during re gistration review.

• The developmental n eurotoxicity study ( DNT) was previously not requested for taufluvalinate. However, the Agency has ne w information regarding the potential for increased susceptibility in juveniles from pyrethroid exposures, and therefore, the DNT study is currently required fo r all pyrethroids, including ta u-fluvalinate. Despite the existing DNT requirement, the Agency has determined that conducting additional DNT studies on any pyrethroids is not likely to contribute new in formation relevant for risk assessment. EPA believes the existing DNTs on six pyrethroids (bifenthrin, cyfluthrin, cyhalothrin, cypermethrin, fenpropathrin and de ltamethrin) provide sufficient information

to determine that the conclusions drawn from the DNTs, as combined, are applicable to all pyrethroids. Thus, EPA is hopeful that the registrants with DNT requirements will elect to cite the existing database to satisfy the DNT requirement rather than devoting

new substantial resources associated with performing and evaluating new DNT studies. Detailed considerations supporting th is conclusion can be found in “ Pyrethroids: Evaluation of Data from DNTs & Cons ideration of Comparative Sensitivity”

, available at http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html

.

• The Agency intends to require the following da ta in the registration review DCI for taufluvalinate in order to conduct a complete human health assessment:

o GLN 870.7800 – Immunotoxicity

o GLN 870.1300 – Acute inhalation

o GLN 870.3465 – 90-day i nhalation toxicity 2

o GLN 870.6200 – Acute neurotoxicity

o GLN 870.6300 – Developmental neurotoxicity

o GLN 870.3250 – 90-day dermal toxicity

• The Agency will make a decision regarding the need for an FQPA or other database uncertainty/safety factors for tau-fluvalinate following receipt of re quired toxicity data and following a final determination of the potential for increased susceptibility of infants and children to pyrethroid pest icides based on the results of all available data.

• Tau-fluvalinate is a member of the pyrethroid class of insecticides. This class also includes permethrin, cypermethrin, cyfluthri n, tau-fluvalinate, bife nthrin, fenpropathrin, and lambda-cyhalothrin, among others. EPA developed a draft science policy document

2 While the inhalation guideline calls for a 90-day study duration, a 28-day study duration will satisfy the Agency’s inhalation exposure data needs, and this will be noted in the data call-in that the Agency intends

to issue.8 on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and pyrethroids, draft, May 19, 2009; http://www.regulations.gov/search/R egs/home.html#documentDetail?R=09000064809a6

2df ). This document was supported by the FI FRA Scientific Adviso ry Panel (SAP) and

is available in the docket ( http://www.regulations.gov/search/R egs/home.html#documentDetail?R=0900006480a1f

8d7 ). EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comments. Pesticides with a common 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 Si mulation (SHEDS) probabilistic exposure model, which are important for the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokineti c models for several pyrethroids. The status of both of these research modeling efforts was reviewed by the FIFRA SAP in July, 2010 and meeting materials are available in the docket ( http://www.regulations. gov/search/Regs/home.html#doc ketDetail?R=EPA-HQ-OPP2010-0378 )

. For information regarding EPA’s efforts to evaluate the risk to pyrethroids,

see http://www.epa.gov/oppsrrd1/reevaluati on/pyrethroids-py rethrins.html.

• Please refer to Tau-fluvalinate. Human Health Asse ssment Scoping Document in Support of Registration Review, located in the docket, for a deta iled discussion of the anticipated

risk assessment needs for human health.

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 may 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 issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredient s (ais) 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-application9 agricultural scenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Tau-fluvalinate is not among the group of 58 pesticid e ais on the initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for all registration review cases, including those for which EPA has alr eady opened a registration review docket for a pesticide ai.

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/.

Timeline:

EPA has created the following estimated timeline for the completion of tau-fluvalinate registration review.

Registration Review for Tau-fluvalinate – Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Comment Period 2010 – December Close Public Comment 2011 – February Case Development Final Work Plan 2011 – May

Issue DCI 2012 – Jan. – March

Data Submission 1 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

Decision 2 2018 – Jan. – March

Close Public Comment Period 2018 – April – June Registration Review Decision and Begin Post-Decision Follow-up 2018 Total (years) 8

1. If the registrants choose to cite the 6 previously subm itted DNT studies as explained above, then this time estimate will likely be shortened by approximately 2 years.

2. 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 consid er all comments as well as any additional10 information or data provided in a timely manner pr ior to issuing a final work plan (FWP) for taufluvalinate.

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 tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Tau-fluvalinate 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=88

5 . However, the pyrethroids as a group have been identified as a cause for impairment for three water bodies in Central Valley, CA: Del Puerto Creek, Ingram Creek Site (confluence with Hospital Creek to Hwy 33 crossing) and second In gram Creek Site (confluence with San Joaquin River to confluence with Hospital Creek).

Nonetheless, no Total Maximum Daily Loads (TMD L) have been developed for tau-fluvalinate, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&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 exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in O PP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitati vely in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to tau-fluvalinate, compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to the general population.11 Other Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the risk assessments, incl uding 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 in units rela ted to mass per unit area of treatment

zone

e. frequency of application, applicati on intervals and maximum number of applications per season

f. geographic limitations on use

2. use or potential use di stribution use history

3. application timing (date of first appl ication and applica tion intervals)

4. typical interval (days)

5. state or local use restrictions

6. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

7. monitoring data, including existing or ongoi ng Publically Owned Treatment Works

effluent monitori ng data for the pyrethroids.

Next Steps:

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner, and th en issue a FWP for tau-fluvalinate.

II. FACT SHEET

• Pesticide Chemical (PC) code: 109302

• Chemical Abstract Service (CAS) number: 102851-06-9

• Registration review case number: 2295

• Technical registrant: Wellmark International

• First registered for use in the U.S. in 1983.

• The RED for tau-fluvalinate wa s completed on September 28, 2005.

• There are currently 4 end-use products and 1 technical pr oduct registered.

• There are two Special Local Need (SLN) regi strations for California for use on carrots, brassica vegetables, and cole crops (non- food uses; crops are grown for seed).

• Impregnated plastic strips used to treat varroa mites in beehives is the only food use, and the only tolerance is for tau- fluvalinate residues in honey.

• Pesticide Re-evaluation Di vision Chemical Review Manager: Molly Clayton, clayton.molly@epa.gov12 • Registration Division Co ntact: Richard Gebken, gebken.richard@epa.gov

Use & Usage Information: (For additional details, please refer to the Appendix A and SLUA documents in the tau-fluvalinate docket.)

• Tau-fluvalinate is a broad-spectrum insectic ide/miticide in the pyrethroid class of pesticides used to control a variety of post-emer gent insects. It is registered for a single food use (beehives/honey) and several non-food uses, including commercial and residential ornamentals (outdoor and container-grown, greenhous e, interior plantscapes, dip for cuttings), building surfaces/perimeters, ant mounds and certain crops (carrots and brassica/cole crops) grown for seed.

• Formulation types include: re ady-to-use liquids, flowable concentrate, and impregnated strips (bee hives).

• Tau-fluvalinate application methods include aerial (in California for the SLN), dipping, spray, fogger outdoor perimeter treatments, a nd impregnated plastic strips. Spoon or

mound drench methods are used for ant mound treatments.

• The maximum concentration in residentia l outdoor use product s is 0.61% ai. Taufluvalinate is labeled for use on greenhouse (non-food) plants, outdoor and interior ornamentals, Eugenia and pepper trees, and mou nd drenches at 0.34 lb ai/A. It is labeled for use on brassica/cole and carrot crops grown for seed in California at 0.15 lb ai/A; on flower and foliage cuttings at 5.0 fl oz ai/ 100 gal (as a dip); and on building perimeters at 3 tsp ai/5 gal/1000 sq ft. Use in beehives is labeled as one strip for each, of five combs or

less in each bee chamber.

• Based on the 2010 SLUA, less than 500 pounds of ta u-fluvalinate ai is used per year for agricultural proposes. It is pr imarily used on carrots grown fo r seed in California. The extent of current non-agricultural uses is unknown.

Recent and Pending Actions :

• The tau-fluvalinate labels have been amended to incorporate mitigation measures specified in the 2005 RED.

• In November, 2006 two new end-use products (EPA registration numbers 72155-71 and 72155-73) were registered for outdoor residential (homeowner) use, on sites such as flowers, ground covers, or namentals, and shrubs.

Ecological Risk Assessment Status :

The following are key findings of the most recent eco logical risk assessments for tau-fluvalinate.

Please refer to the Registration Review: Preliminary Probl em Formulation for Ecological Risk,13 Environmental Fate, Endangered Species, and Drin king Water Assessment for Tau-fluvalinate

, located in the docket, for a detailed discussi on of previous ecological risk assessments.

• The most recent ecological assessment, completed in July 2005, identified potential acute and chronic risks to aquatic organisms and ma mmals. There was also a concern for nontarget terrestrial invertebrates.

• In 2005, there were significant ecological data gaps, which limited the Agency’s ability to assess acute risk to aquatic organisms, a quatic plants, and terrestri al plants and chronic

risk to marine/estuarine invertebrates. Th e risk assessment did not indicate a concern for birds, based on data available at the time

• The use pattern for tau

- fluvalinate suggested that the potential risks would likely be limited to those geographic areas where the chemical is most widely used, including use on ornamentals in California, Oregon, Mich igan, Florida, Pennsylvania, and Texas.

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for taufluvalinate. Please refer to Tau-fluvalinate: Human Health Assessment Scoping Document in Support of Registration Review

, located in the docket, for a de tailed discussion of previous

human health risk assessments.

• The most recent comprehensive human health risk assessment was completed September 2005 in support of reregistration.

Hazard Characterization:

• Tau-fluvalinate, like other pyr ethroid insecticides, causes ne urotoxicity in insects and mammals by the modulation of nerve axon sodi um channels. Pyreth roids interfere with the ability of the nervous system to relay nerv e transmissions resulting in effects such as tremors, excessive grooming, and salivation. Similar signs of neurotoxicity were observed in the guideline studies conducted with tau-fluvalinate.

• Data indicate no evidence of carcinogenicity in mice or rats, and there is no concern for mutagenicity.

• At the time of reregistration, A 100X uncer tainty factor was used to account for interspecies extrapolation and intraspecies variability (10X and 10X, respectively). Based on a review of both hazard and exposur e data, the Agency reduced the special FQPA safety factor to 1X.

Dietary (Food and Drinking Water):14 • In 2005, exposure from drinking water was inco rporated in the acute and chronic risk assessments using the 1-in-10 year annual p eak and average concentrations of surface water, respectively. Nearly all the estimated dietary exposure to tau-fluvalinate was from drinking water.

• The acute and chronic dietary (food + drinki ng water) risk estimates were below the Agency’s level-of-concern for the gene ral population and a ll population subgroups.

Residential:

• In 2005, since there were no registered homeo wner uses, a residential handler risk assessment was not performed. The commercial a pplications to residential settings were limited to spot treatments or building peri meters, resulting in minimal potential postapplication exposure. In accordance with th e Agency’s standard residential assessment practices, post-app lication risk was not assessed.

Aggregate:

• The 2005 aggregate risk assessment considered only combined food and drinking water exposures. The aggregate risk estimates were below the Agency’s level-of-concern.

Occupational :

• The 2005 occupational risk assessment consider ed inhalation exposure only; risk from potential occupational dermal exposures was not assessed quantitatively. No toxicity endpoint was selected for dermal exposure in available toxicology studies, and dermal exposures to products containing tau-fluvalinate were expected to be largely self-limiting

due to the irritation that occurs as a result of the “pyrethroid reac tion”, characterized by tingling sensations and/or itch ing, often severe, upon contact w ith the chemical. Potential dermal risk was addressed by la beling instructing the user to avoid contact with skin and

instructions to wash the affected area immediately following contact.

• At the time of the RED, the Agency did not have data with which to estimate possible tau-fluvalinate exposures from the greenhouse fogger use. To address this area of uncertainty, the Agency required an occupa tional post-application exposure study for greenhouse exposure scenarios (OPPTS Guidel ine 875.2500). These data were submitted

and confirmed that the 12-hour restricted entry interval specif ied in the 2005 was adequately protective of post-appli cation greenhouse inhalation risk.

• All occupational handler and pos t-application inhalation risk estimates were below the Agency’s level-of-concern.

Cumulative:15 • Tau-fluvalinate is a member of the pyrethroid class of insecticides. This class also includes permethrin, cypermethrin, cyfluthri n, tau-fluvalinate, bife nthrin, fenpropathrin, and lambda-cyhalothrin, among others. EPA developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and pyrethroids, draft, May 19, 2009; http://www.regulations.gov/search/R egs/home.html#documentDetail?R=09000064809a6

2df ). This document was supported by the FI FRA Scientific Adviso ry Panel (SAP) and

is available in the docket (http://www.regulations.gov/search/R egs/home.html#documentDetail?R=0900006480a1f

8d7 ). EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comments. Pesticides with a common 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 Si mulation (SHEDS) probabilistic exposure model, which are important for the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokineti c models for several pyrethroids. The status of both of these research modeling efforts was reviewed by the FIFRA SAP in July, 2010 and meeting materials are available in the docket (http://www.regulations. gov/search/Regs/home.html#doc ketDetail?R=EPA-HQ-OPP2010-0378 ). For information regarding EPA’s effort s to evaluate the risk to pyrethroids, see http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids- pyrethrins.html.

Incidents:

Ecological:

• The Agency consulted the Ecological Incident Information System database for reports of ecological incidents, and no incidences have been reported for tau-fluvalinate.

Human Health:

• The OPP Incident Data System (IDS) and the Sentinel Event Notification System for Occupational Risk-Pesticides (S ENSOR) databases were consu lted for pesticide incident data on the active ingred ient tau-fluvalinate.

o For IDS, from 2000 to May 25, 2010 there are 90 cases reported for taufluvalinate of minor, unknown, or no effects. For these minor incidents, there are no individual reports available that would provide details about the incidents, and single chemical incidents are not distinguish ed from multiple chemical incidents. There was one case reported for tau-fluvali nate in the database with moderate severity. In this case, an unknown age female reported dermal effects.16 o For NIOSH SENSOR from 1998 to 2007, seven cases of low to moderate severity were reported that involved the active i ngredient tau-fluvali nate. The health effects reported included: gastrointestinal , respiratory, ocular , neurological, and

dermal.

Tolerances and International Harmonization:

The only U.S. tolerance is established for tau- fluvalinate residues in honey. Currently, Codex, Canada, and Mexico do not have MRLs established for the use of tau-fluvalinate. The Agency will work to harmonize tolerances/MRLs during registration review as appropriate.

DCIs:

A generic DCI (GDCI-109302-26155) was issued for tau-fluvalinate in March 2007. All data requirements identified in the DCI have been fulfilled.

Labels :

Active Section 3 registrations ca n be obtained from the Pesticid e Product Label System (PPLS)

website at http://oaspub.epa.gov/ pestlabl/ppls.home

.

III. Summary of Data Gaps – Tau-fluvalinate

The table below summarizes all anticipated data needs for tau-fluvalinate.

Guideline

Number Anticipated Data RequirementTestMaterialEstimatedTimeframe

850.4100 Seedling emergence Tier II 1 TGAI 12 850.4150 Vegetative vigor, Tier II 1 TGAI 12

850.4400 Aquatic plant growth (vascula r plant toxicity), Tier II 1 TGAI 12

850.5400 Aquatic plant growth (a lgal plant toxicity), Tier II 1 TGAI 12 835.4300 Aerobic aquatic metabolism TGAI 24 835.4400 Anaerobic aquatic metabolism TGAI 24 835.6100 Terrestrial field dissipation TGAI 24 850.1500 Fish full life cycle for one freshwater species TGAI 24 850.1400 Fish early-life stage toxicity test for one freshwater species TGAI 12 850.1350 Aquatic invertebrate life-cycle for mysid shrimp TGAI 12 850.2100 Avian oral toxicity test for passerine species TGAI 12 850.1025 Acute toxicity to estuarine/marine invertebrate for the oyster TGAI 12

Nonguideline Test for Measuring the Effects of Sediment Associated Contaminants on Survival, Growth, and Reproduction on TGAI 2417 Guideline

Number Anticipated Data RequirementTestMaterialEstimatedTimeframe

Hyalella azteca in USEPA 2000 Methods for Measuring the Toxicity and Bioaccumulation of Sediment-associated

Contaminants with Freshwater Invertebrates. EPA 600/R99/064

Nonguideline Life-cycle Test for Measuring the Effects of Sedimentassociated Contaminants on Chironomus dilutus or C. tentans in USEPA 2000 Methods for Measuring the Toxicity and

Bioaccumulation of Sediment-associated Contaminants with

Freshwater Invertebrates. EPA 600/R-99/064 TGAI 24

Nonguideline Leptocheirus plumulosus in USEPA 2001 Method for Assessing the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants with the Amphipod Leptocheirus plumulosus. EPA 600/R-01/020 TGAI 24

870.7800 Immunotoxicity TGAI 12 870.1300 Acute inhalation toxicity study TGAI 8 870.3465 90-day inhalation toxicity study 2 TGAI 24 870.6200 Acute neurotoxicity TGAI 24 870.6300 Developmental neurotoxicity 3 TGAI 48 870.3250 90-day dermal toxicity study TGAI 24

1 The Agency anticipates requiring a Tier II study. A Ti er I study may be conducted in lieu of a Tier II study with the understanding that adverse effects (even if <25%) would necessitate a Tier II study as well. The purpose of a Tier II study is to establish eith er a No Observed Adverse Effect Concentration (NOAEC) or a concentration at which there is a 5% obser ved effect (EC05) to be used in an endangered species risk assessment for nontarget plants. If neither an NOAEC nor an EC05 value is available, then the Agency may have to presume that tau-fluvalinat e "may affect" listed nontarget plant species in the registration review endangered species risk assessment.

2 While the inhalation guideline calls for a 90-day study duration, a 28-day study duration will satisfy the Agency’s inhalation exposure data needs, and this will be noted in the data call-in that the Agency intends

to issue.

3 EPA believes the existing DNTs on six pyrethroids (bif enthrin, cyfluthrin, cyhalothrin, cypermethrin, fenpropathrin and deltamethrin) provide sufficient info rmation to determine that the conclusions drawn from the DNTs, as combined, are applicable to all pyreth roids. Thus, EPA is hopeful that the registrant will cite the existing database to satisfy the DNT requirement rather than devoting new substantial resources to performing and evaluating a new DNT study for tau-fluvalinate.