US EPA - Pesticides - Reregistration Eligibility Decision .

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United StatesEnvironmental ProtectionAgencyPrevention, Pesticidesand Toxic Substances(7508C)EPA XXX-X-XX-XXXSeptember, 2005ReregistrationEligibility Decision forTau-fluvalinate

Reregistration Eligibility Decision (RED) forTau-fluvalinateList ACase No. 2295Approved by:Debra Edwards, Ph.D., DirectorSpecial Review andReregistration DivisionDate:ii

TABLE OF CONTENTSExecutive Summary . . 1I.Introduction.5II.Chemical Overview .6A. Regulatory History .6B. Chemical Identification .6C. Use Profile.7D. Estimated Usage of Pesticide.8III.Summary of Tau-fluvalinate Risk Assessments .8A. Human Health Risk Assessment .91. Toxicity of Tau-fluvalinate.9a.Toxicity Profile.9b. FQPA Safety Factor Determination.10c.Toxicological Endpoints for Risk Assessment .112. Dietary Exposure and Risk .12a.Exposure Assumptions .12b. Estimated Drinking Water Concentration .13c.Population Adjusted Dose .13d.Dietary (Food and Drinking Water) Risk Estimates.143. Residential and Non-Occupational Exposure.154. Aggregate Exposure and Risk.155. Occupational Risk .16a.Occupational Toxicity.16b. Occupational Handler Risk .17c.Occupational Post-Application Risk .196.Human Incident Data .20B. Environmental Risk Assessment .201. Environmental Fate and Transport .212. Ecological Risk Estimations .213. Risk to Aquatic Organisms .224. Risk to Terrestrial Organisms .25a.Birds .26b. Mammals .265. Non-Target Insects .276. Non-Target Plant Exposure and Risk.287. Ecological Incidents.288. Risk to Federally Listed Endangered and Threatened Species .28IV.Risk Management, Reregistration, and Tolerance Reassessment Decision .29A. Determination of Reregistration Eligibility.29B. Regulatory Position .291. Food Quality Protection Act Findings .29a. “Risk Cup” Determination.29b. Determination of Safety to U.S. Population.30c. Determination of Safety to Infants and Children .302. Endocrine Disruptor Effects .30iii

3.Cumulative Risks.31C. Tolerance Reassessment Summary.31D. Regulatory Rationale.321. Human Health Risk .322. Environmental Risk.33a. Fish and Aquatic Invertebrate Risk.34b. Avian Risk.35c. Mammalian Risk .35d. Non-Target Terrestrial and Aquatic Plant Risk.35e. Non-Target Insects .36E. Labeling Requirements .361. Endangered Species Considerations .362. Spray Drift Management .36V. What Registrants Need to Do .37A. Manufacturing Use Products .371. Additional Generic Data Requirements .372. Labeling for Manufacturing-Use Products.39B.End-Use Products .391. Additional Product-Specific Data Requirements .392. Labeling for End-Use Products.39C. Labeling Changes Summary Table.40VI.Appendices.45iv

GLOSSARY OF TERMS AND ymg/LMOEMRIDMUPNANAWQANIOSHNPDESNRActive IngredientAcute Population Adjusted DoseAmerican Nursery and Landscape AssociationAnticipated ResidueAgricultural Re-entry Task ForceBioconcentration FactorCode of Federal RegulationsChronic Population Adjusted DoseConfidential Statement of FormulaUSDA Continuing Surveys for Food Intake by IndividualsData Call-InDietary Exposure Evaluation ModelDislodgeable Foliar ResidueDevelopmental NeurotoxicityDrinking Water Level of Comparison.Emulsifiable Concentrate FormulationEngineering ControlElectron Capture DetectionEstimated Drinking Water ConcentrationEstimated Environmental ConcentrationEnvironmental Protection AgencyEnd-Use ProductFood and Drug AdministrationFederal Insecticide, Fungicide, and Rodenticide ActFederal Food, Drug, and Cosmetic ActFood Quality Protection ActFunctional Observation BatteryGranular FormulationGas ChromatographyGuideline NumberHighest Average Field TrialIndex ReservoirMedian Lethal Concentration. A statistically derived concentration of a substance that can be expectedto cause death in 50% of test animals. It is usually expressed as the weight of substance per weight orvolume of water, air or feed, e.g., mg/l, mg/kg or ppm.Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% ofthe test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed asa weight of substance per unit weight of animal, e.g., mg/kg.Level of ConcernLimit of DetectionLowest Observed Adverse Effect LevelMicrograms Per GramMicrograms Per LiterMilligram Per Kilogram Per DayMilligrams Per LiterMargin of ExposureMaster Record Identification (number). EPA's system of recording and tracking studies submitted.Manufacturing-Use ProductNot ApplicableUSGS National Water Quality AssessmentNational Institute of Occupational Safety and HealthNational Pollutant Discharge Elimination SystemNot Requiredv

NOAELNo Observed Adverse Effect LevelNOECNo Observed Effect LevelOPPEPA Office of Pesticide ProgramsOPPTSEPA Office of Prevention, Pesticides and Toxic SubstancesPADPopulation Adjusted DosePCAPercent Crop AreaPDPUSDA Pesticide Data ProgramPHEDPesticide Handler's Exposure DataPHIPreharvest IntervalppbParts Per BillionPPEPersonal Protective EquipmentppmParts Per MillionPRZM/EXAMS Tier II Surface Water Computer ModelREDReregistration Eligibility DecisionREIRestricted Entry IntervalRfDReference DoseRQRisk QuotientSCI-GROW Tier I Ground Water Computer ModelSAPScience Advisory PanelSFSafety FactorSLCSingle Layer ClothingSLNSpecial Local Need (Registrations Under Section 24C of FIFRA)TGAITechnical Grade Active IngredientUSDAUnited States Department of AgricultureUSGSUnited States Geological SurveyUFUncertainty FactorUVUltravioletWPSWorker Protection Standardvi

TAU-FLUVALINATE TEAMOffice of Pesticide Programs:Health Effects Risk AssessmentSusan StantonJeff EvansRobert TravagliniJose MoralesJohn DohertyEcological Fate and Effects Risk AssessmentMark CorbinPamela HurleyBiological and Economics Analysis AssessmentBill GrossTimothy KielyElisa RimColwell CookRegistration DivisionGeorge LaroccaRisk ManagementMolly ClaytonKimberly NesciNeil Andersonvii

Executive SummaryEPA has completed its reregistration eligibility determination and tolerance reassessmentdecision for the pesticide tau-fluvalinate. There is one tolerance being reassessed for tau fluvalinate. The risk assessments, which are summarized below, are based on review of therequired target data base supporting the use patterns of currently registered products andadditional information received. The Agency has determined that products containing tau fluvalinate are eligible for reregistration provided that data and regulatory needs are addressedand labels are amended accordingly. The decision is discussed fully in this document.Tau-fluvalinate is a broad-spectrum insecticide/miticide in the pyrethroid class ofpesticides. It is registered for a single food use (beehives/honey) and several non-food uses,including ornamentals (outdoor and container-grown, greenhouse, interior plantscapes, dip forcuttings), building surfaces/perimeters, ant mounds and certain crops (carrots and brassica/colecrops) grown for seed. Tau-fluvalinate was first registered in one of its earlier forms, racemicfluvalinate, in 1983. With an estimated 11,000 pounds of active ingredient (a.i.) used per year, ithas minimal domestic usage. The majority of the usage is in commercial greenhouses and onoutdoor field- and container-grown ornamentals. The residential uses are very limited(approximately 600 pounds a.i. annually on spot application to ant mounds and outdoor buildingperimeters), and no homeowner applications are allowed. Therefore, there is little potential forresidential exposure.EPA is not currently following a cumulative risk approach based on a commonmechanism of toxicity for the pyrethroid class of pesticides. Although all pyrethroids interactwith sodium channels, there are multiple types of sodium channels, and it is currently unknownwhether they have similar effects on all channels. In addition, we do not have a clearunderstanding of effects on key downstream neuronal function, e.g., nerve excitability, nor do weunderstand how these key events interact to produce their compound-specific patterns ofneurotoxicity. There is ongoing research by both the EPA’s Office of Research andDevelopment and the pyrethroid registrants to evaluate the differential biochemical andphysiological actions of pyrethroids in mammals. This research is expected to be completed by2007. When the results of this research are available, the Agency will make a determination ofcommon mechanism of toxicity as a basis for assessing cumulative risk.Overall Risk SummaryTau-fluvalinate dietary risks from food and drinking water sources are low and not ofconcern to the Agency. Although tau-fluvalinate is labeled for use in residential areas, neither aresidential handler estimate nor a residential post-application estimate was necessary, becausethere is little potential for exposures from these uses. For ecological risks, tau-fluvalinateexceeds the Agency level of concern (LOC) for acute and chronic risk to aquatic organisms, andexceeds the Agency LOC for chronic risk to mammals. Risk to terrestrial invertebrates may alsobe a concern, because tau-fluvalinate is highly toxic to bees. There is uncertainty, however,surrounding the aquatic organism toxicity values used in this assessment. Exposureconcentrations in the available studies were either not measured or were inconsistent. The acutetoxicity studies for all aquatic species were classified as supplemental because of the apparent1

rapid decline of the test material in the static studies, most likely due to adsorption of tau fluvalinate to the glass chambers. In addition, the chronic studies had analytical variability. TheAgency intends to issue a data call in (DCI) requiring additional data to address this area ofuncertainty.Dietary Risk – Food and Drinking WaterThe acute dietary risk estimates for the U.S. general population and all populationsubgroups are less than 6% of the acute population adjusted dose (aPAD). The Agency’s levelof concern (LOC) is 100% of the aPAD, and therefore, acute dietary risk estimates are below theAgency’s LOC. Similarly, the chronic aggregate risk estimates for the U.S. general populationand all population subgroups are less than 1% of the chronic population adjusted dose (cPAD)and, therefore, below the Agency’s LOC.Residential RiskAlthough tau-fluvalinate is labeled for use in residential areas, neither a residentialhandler estimate nor a residential post-application estimate was necessary since there is littlepotential for exposure from these uses. Tau-fluvalinate may be applied, primarily by spotapplication, in residential areas to outdoor building surfaces/perimeters and ant mounds bycommercial applicators only (i.e., no homeowner applications are permitted).Aggregate RiskAggregate risk refers to the combined risk from food, drinking water, and residential andany non-occupational (if applicable) exposures. In the case of tau-fluvalinate, the aggregate riskestimates only consider combined food and drinking water exposures because no residential usesare expected to contribute to chronic or acute exposures of this chemical. The acute aggregaterisk estimates for the U.S. general population and all population subgroups are less than 6% ofthe aPAD and, therefore, below the Agency’s level of concern. Similarly, the chronic aggregaterisk estimates for the U.S. general population and all population subgroups are less than 1% ofthe cPAD and, therefore, below the Agency’s level of concernOccupational RiskWorkers can be exposed to tau-fluvalinate through mixing, loading, applying thepesticide, or re-entering treated sites. A dermal exposure assessment was not conducted, sincedermal exposure to tau-fluvalinate is expected to be largely self-limiting due to the irritation thatoccurs on contact with the pyrethroid pesticide. Current labels require the use of chemicalresistant gloves for all applicators and handlers.The Agency has concern for inhalation margins of exposure below 100. All inhalationmargins of exposure (MOEs) for tau-fluvalinate exceed 100 for all occupational handlerscenarios assessed at baseline personal protective equipment (long sleeve shirt, long pants, shoesand socks), and are therefore, not of concern.2

With the exception of the greenhouse uses, post-application inhalation exposure to tau fluvalinate is expected to be minimal. Potential post-application inhalation exposure ingreenhouses will be mitigated by the ventilation requirements of the Worker Protection Standard(WPS). For these reasons, a post-application inhalation exposure assessment was not deemednecessary for tau-fluvalinate. However, to confirm that the established restricted-entry interval(REI) of 12 hours is adequate, the Agency is requiring the registrant to conduct an inhalationpost-application exposure study.Ecological RiskThe Agency has conducted a screening-level ecological and environmental riskassessment for the registered uses of tau-fluvalinate. Based on the available data, the Agencyhas identified potential acute and chronic risks of concern to aquatic organisms and chronic risksof concern to mammals. There is also a concern for non-target terrestrial invertebrates. Thescreening-level risk assessment does not indicate a risk concern for birds.There is significant uncertainty with the risk estimations due to the uncertaintysurrounding the toxicity values used in this assessment. The toxicity data for all aquatic specieswere classified as supplemental due to the likely adsorption of tau-fluvalinate to the glasschambers. The toxicity of tau-fluvalinate could be greater than indicated by the assessment. TheAgency is requiring additional data to address this area of uncertainty.While there are slight estimated exceedence of the LOC for some terrestrial and aquaticspecies, and uncertainty surrounding the aquatic organism toxicity values, the ecological riskassociated with the use of tau-fluvalinate is expected to be limited based on its use pattern,amount used, and toxicity profile. The majority of the outdoor uses of tau-fluvalinate are innurseries, which generally are not present in large contiguous acreages. Moreover, much of theuse in nurseries is for containerized plants, and applications in nurseries are made by hand wand.Although the groundboom application method for tau-fluvalinate is prohibited for nurseries, themodeling the Agency uses is based on the use of a groundboom; thus, the Agency’s currentenvironmental modeling capabilities are limited in being able to quantitatively refine exposureestimates to aquatic organisms. While it is recognized that hand wand application is moretargeted than the groundboom application method, resulting in less runoff and

Reregistration Eligibility Decision for Tau-fluvalinate . Reregistration Eligibility Decision (RED) for Tau-fluvalinate . Biological and Economics Analysis Assessment Bill Gross Timothy Kiely Elisa Rim Colwell Cook . (approximately 600 pounds a.i. annually on spot application to ant mounds and outdoor building

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