US EPA - Pesticides - Revised Tetramethrin RED US EPA .

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United StatesEnvironmental ProtectionAgencyPrevention, Pesticidesand Toxic Substances(7508P)EPA 738-R-08-012ReregistrationEligibility Decision(RED) Document forTetramethrinRevised April 2010

TABLE OF CONTENTSI. Introduction. 1II. Chemical Overview. 2A. Regulatory History. 2B. Chemical Identification. 2C. Use Profile. 3D. Estimated Usage of Pesticide. 4III. Summary of Tetramethrin Risk Assessments . 6A. Human Health Risk Assessment. 61. Toxicity of Tetramethrin. 72.Carcinogenicity of Tetramethrin . 103.Metabolites and Degradates. 104.Dietary Exposure and Risk (Food and Water) . 115. Residential Exposure and Risk . 116.Aggregate Exposure and Risk. 167.Occupational Exposure and Risk . 168.Cumulative Exposure and Risk . 189.Tetramethrin Human Incident Reports. 19B. Environmental Risk Assessment. 201.Environmental Fate and Transport. 202.Ecological Exposure and Risk. 213.Adverse Ecological Incidents . 244.Endangered Species Considerations . 25IV. Risk Management, Reregistration, and Tolerance Reassessment Decision. 27A. Determination of Reregistration Eligibility. 27B. Public Participation. 27C. Regulatory Position. 271. Regulatory Rationale . 272.Endocrine Disruptor Screening Program. 293.Endangered Species . 29D. Labeling Requirements. 30V. What Registrants Need to Do. 31A. Manufacturing Use Products . 311.Additional Generic Data Requirements. 312.Labeling for Manufacturing-Use Products . 31B. End-Use Products. 321.Additional Product-Specific Data Requirements. 322.Labeling for End-Use Products . 32C. Labeling Changes Summary Table . 34Appendix A. Non-Food and Non-Feed Use Patterns Subject to the Reregistration ofTetramethrin . 52Appendix B. Data Supporting Guideline Requirements for Tetramethrin. 53Appendix C. Technical Support Documents. 56Appendix D. Bibliography . 57Appendix E. Tetramethrin Acute Mammalian Toxicity Batching . 64

Glossary of Terms and EIRfDRQSFSLCSLNTGAIUSDAUFUFdbActive IngredientCode of Federal RegulationsConfidential Statement of FormulaData Call-InDislodgeable Foliar ResidueDevelopmental NeurotoxicityEmulsifiable Concentrate FormulationEstimated Environmental ConcentrationEnvironmental Protection AgencyEnd-Use ProductFederal Insecticide, Fungicide, and Rodenticide ActFederal Food, Drug, and Cosmetic ActGranular FormulationGuideline NumberHigh pressureMedian 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 ConcernLowest Observed Adverse Effect LevelLow pressureMilligram Per Kilogram Per DayMilligrams Per LiterMargin of ExposureMaster Record Identification (number). EPA's system of recording and tracking studies submitted.Manufacturing-Use ProductNot ApplicableNon-Dietary Exposure Task ForceNot Likely to Adversely AffectNot RequiredNo Observed Adverse Effect LevelEPA Office of Pesticide ProgramsEPA Office of Prevention, Pesticides and Toxic SubstancesPercent Crop AreaPesticide Handler's Exposure DataPreharvest IntervalParts Per BillionPersonal Protective EquipmentParts per MillionReregistration Eligibility DecisionRestricted Entry IntervalReference DoseRisk QuotientSafety FactorSingle Layer ClothingSpecial Local Need (Registrations Under Section 24(c) of FIFRA)Technical Grade Active IngredientUnited States Department of AgricultureUncertainty FactorDatabase Uncertainty Factoriv

TETRAMETHRIN TEAM MEMBERSOffice of Pesticide Programs:Health Effects Risk AssessmentBecky DaissMarquea KingAbdallah KhasinawahMatt CrowleySusan HummelEcological Fate and Effects Risk AssessmentWilliam EckelWanda HallRichard LeeIbrahim Abdel-SahebDana SpatzBiological and Economics Analysis AssessmentLaVerne DobbinsNikhil MallampalliJihad AlsadekRegistration DivisionRichard GebkenCarmen RodiaRisk ManagementJacqueline GuerryMonica WaitNeil Andersonv

Summary of Revisions to the Tetramethrin Reregistration Eligibility DecisionThe Reregistration Eligibility Decision (RED) document for Tetramethrin was signed onJune 23, 2008, and is available on the Federal Docket Management System (FDMS), available athttp://www.regulations.gov (document # EPA-HQ-OPP-2008-0014-0019). Although a publiccomment period did not follow the RED, the Agency did receive comments from the registrantsregarding the need for clarification and corrections in Appendix A, as well as clarification oflabel statements in Table 12, Summary of Labeling Changes for Tetramethrin. Further, in the2008 RED, the Agency assessed the indoor aerosol space spray scenario at a maximumapplication rate of 0.25% active ingredient (a.i). To support indoor aerosol space spray productsup to 0.35% a.i., the registrants submitted a revised Cumulative and Aggregate Risk EvaluationSystem (CARES ) assessment for this scenario and a short-term incidental oral benchmark dose(BMD) analysis in order to revise the endpoint for incidental oral exposure. Finally, theregistrants requested the Agency review existing acute toxicological studies previously submittedto the Agency in order to address data gaps identified in the 2008 RED document.As a result of these post-RED discussions with the registrants and the review of existingand new toxicity data, the Agency has revised the Tetramethrin RED, where appropriate, in orderto correct any errors, clarify the intent of its risk mitigation captured in Table 12, reflect therevised occupational and residential risk assessments, and revise the acute toxicity data gaps anddata-call in requirements.The major revisions to the human health risk assessment and data needs are as follows: The Agency reviewed the Guideline 870.2400 Primary Eye Irritation Testing (MRID#41609611) submitted by Sumitomo Chemical Inc., and found the study to be acceptable.Therefore, in Section III, Summary of Tetramethrin Risk Assessments, the acute toxicityprofile (Table 2) was revised to reflect this data requirement as fulfilled and tetramethrinas a category III eye irritant. Additionally, the need for Guideline 870.2400 Primary Eye Irritation Testing wasremoved from Section V, Additional Generic Data Requirements. The Agency determined the “Evaluation of Potential Human Health Risks Associatedwith Residential Uses of Tetramethrin: Revised Supplemental – Short-term OralBenchmark Dose Analysis,” (MRID# 47921601) submitted by the registrant onNovember 30, 2009 to be acceptable. As a result, the short-term incidental oral endpointfor use in the human health risk assessment was revised from 25 mg/kg/day to 61.1mg/kg/day. The occupational handler inhalation risk assessment was revised to reflect the increasedrate of 0.35% for aerosol space sprays. The revised margin of exposure (MOE) of 9,000is below the Agency’s level of concern (LOC), and therefore, continues to be not ofconcern to the Agency (MOEs 1,000 are not of concern).vi

The residential handler risk assessment was also revised to reflect the increased rate of0.35% for aerosol space sprays. The revised MOE of 54,000 is below the Agency’sLOC, and therefore, continues to be not of concern to the Agency. The residential postapplication CARES assessment was also revised to reflect the revised short-termincidental oral end-point and the increased use rate for the indoor aerosol space spray. Inthe 2008 RED, the inhalation MOE for this scenario (using a use rate of 0.25% a.i.) wasnot of concern (MOEs 1,000) at the 99.88th percentile. In the revised CARESassessment, this use scenario (with an application rate of 0.35% a.i. and revised incidentaloral endpoint) is not of concern at the 99.9 percentile (MOE 1,131), and therefore, iseligible for reregistration. The increased use rate of 0.35% is specified in Appendix A.Section 5, What Registrants Need to Do, has been amended to require two additionalgeneric data requirements, Guideline 830.7050 UV / Visible Absorption and Guideline 870.7800Immunotoxicity. Both are new studies which are now required for all pesticide activeingredients. The Additional Product-Specific Data Requirements section has also been amendedto include efficacy data requirements for public health pests and companion animal studies fortetramethrin products used on domestic animals. The determination of which efficacy studieswould be required for tetramethrin was still on-going at the time of publication of the June 2008RED.A number of revisions have also been made to the Summary of Labeling Changes forTetramethrin (Label Table), Table 12, for clarification and to reflect updates in labeling ontetramethrin end-use products. Among the updates are the following: The Agency is requiring the following label statements to reduce the potential ecologicalexposure of tetramethrin. While some of the label statements are additions to the LabelTable, others appeared in Table 12 of the June 28, 2008 Tetramethrin RED document;however, they have been revised slightly to be consistent with other pyrethroid nonagricultural outdoor product labeling.oIncorporation of PR Notice 2008-1, “Environmental Hazard General LabelingStatements on Outdoor Residential Use Products” on appropriate outdoor nonagricultural end-use products.o Products labeled for General Outdoor Surface and Space Sprays (exceptoutdoor fogging devices):“All outdoor applications must be limited to spot or crack-and-crevice treatmentsonly, except for the following permitted uses: Treatment to soil or vegetation around structures; Applications to building foundations up to a maximum height of 3 feet.Other than applications to building foundations, all outdoor applications toimpervious surfaces such as sidewalks, driveways, patios, porches and structuralsurfaces (such as windows, doors, and eaves) are limited to spot treatments orcrack-and-crevice applications, only.”vii

o Products labeled for use around or near floor drains must contain thefollowing statement:“Application is prohibited directly into sewers or drains, or to any area like agutter where drainage to sewers, storm drains, water bodies, or aquatic habitat canoccur. Do not allow the product to enter any drain during