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US EPA-Pesticides; Karate, Lambda-Cyhalothrin

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US EPA-Pesticides; Karate, Lambda-Cyhalothrin UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES MEMORANDUM Date: July 18, 2007 Subject: Lambda-Cyhalothrin. Human Health Risk Assessment for the Proposed Food/Feed Uses of the Insecticide on Cucurbit Vegetables (Group 9), Tuberous and Corm Vegetables (Subgroup 1C), Grass Forage, Fodder, and Hay (Group 17), Barley, Buckwheat, Oat, Rye, Wild Rice, and Pistachios. Petition Numbers 5F6994, 3E6593, and 6E7077. PC Code: 128897 DP Numbers: 313315, 324219, 330542 Regulatory Citation: 40CFR §180.438 Chemical Class: Synthetic Pyrethroid Insecticide Trade Names: Warrior®, Karate® From: William T. Drew, Chemist and Risk Assessor Kim Harper, Toxicologist Anant Parmar, Dietary Exposure Assessor Registration Action Branch 2, Health Effects Division (7509P) and Mark Dow, Occupational/Residential Exposure Assessor Alternate Risk Integration Assessment Team Risk Integration Minor Use & Emergency Response Branch Registration Division (7505P) Through: Dennis McNeilly, Chemist Alan Levy, Toxicologist Margarita Collantes, Biologist Richard A. Loranger, Branch Senior Scientist Christina Swartz, Branch Chief Registration Action Branch 2, Health Effects Division (7509P) To: George LaRocca, Risk Manager Daniel Rosenblatt, Risk Manager Bonaventure Akinlosotu, Risk Manager Reviewer Insecticide Branch, Registration Division (7505P) Page 1 of 71 TABLE OF CONTENTS 1.0 Executive Summary.......................................................................................................... 4 2.0 Ingredient Profile............................................................................................................ 11 2.1 Summary of Registered/Proposed Uses................................................................ 11 2.2 Structure and Nomenclature ................................................................................. 13 2.3 Physical and Chemical Properties......................................................................... 13 3.0 Hazard Characterization/Assessment........................................................................... 14 3.1 Hazard and Dose-Response Characterization....................................................... 14 3.1.1 Database Summary................................................................................... 14 3.1.1.1 Studies Available and Considered ............................................. 14 3.1.1.2 Mode of Action, Metabolism, Toxicokinetic Data .................... 14 3.1.2 Toxicological Effects................................................................................ 15 3.1.3 FQPA ........................................................................................................ 15 3.2 Absorption, Distribution, Metabolism, Excretion (ADME) ................................. 16 3.3 FQPA Considerations ........................................................................................... 17 3.3.1 Adequacy of the Toxicity Database.......................................................... 17 3.3.2 Evidence of Neurotoxicity ........................................................................ 17 3.3.3 Developmental Toxicity Studies............................................................... 18 3.3.4 Reproductive Toxicity Study .................................................................... 18 3.3.5 Pre- and/or Post-Natal Toxicity ................................................................ 18 3.3.5.1 Determination of Susceptibility ................................................. 18 3.3.5.2 Degree of Concern Analysis and Residual Uncertainties.......... 19 3.3.6 Recommendation for a Developmental Neurotoxicity Study................... 19 3.3.7 Rationale for the UFDB.............................................................................. 19 3.4 FQPA Safety Factor for Infants and Children ...................................................... 20 3.5 Hazard Identification and Toxicity Endpoint Selection........................................ 20 3.5.1 Acute Reference Dose (aRfD) - General Population................................ 20 3.5.2 Chronic Reference Dose (cRfD) - General Population............................. 21 3.5.3 Incidental Oral Exposure (Short- and Intermediate-Term)....................... 21 3.5.4 Dermal Absorption.................................................................................... 21 3.5.5 Dermal Exposure (All Durations)............................................................. 21 3.5.6 Inhalation Exposure (All Durations)......................................................... 23 3.5.7 Level of Concern for Margin of Exposure................................................ 24 3.5.8 Recommendation for Aggregate Exposure Risk Assessments ................. 24 3.5.9 Classification of Carcinogenic Potential................................................... 24 3.5.10 Summary of Toxicological Doses and Endpoints..................................... 25 3.6 Endocrine disruption............................................................................................. 27 4.0 Public Health and Pesticide Epidemiology Data.......................................................... 27 5.0 Dietary Exposure/Risk Characterization ..................................................................... 27 5.1 Pesticide Metabolism and Environmental Degradation........................................ 27 5.1.1 Metabolism in Primary Crops................................................................... 27 5.1.2 Metabolism in Rotational Crops ............................................................... 27 5.1.3 Metabolism in Livestock........................................................................... 28 5.1.4 Analytical Methodology........................................................................... 28 Page 2 of 71 5.1.5 Environmental Degradation...................................................................... 29 5.1.6 Comparative Metabolic Profile................................................................. 30 5.1.7 Drinking Water Residue Profile................................................................ 31 5.1.8 Food Residue Profile................................................................................. 32 5.1.9 International Residue Limits..................................................................... 33 5.2 Dietary Exposure and Risk ................................................................................... 33 5.2.1 Acute Dietary Exposure/Risk ..................................................................... 34 5.2.2 Chronic Dietary Exposure/Risk .................................................................. 35 5.2.3 Cancer Dietary Risk.................................................................................... 35 5.3 Anticipated Residue and Percent Crop Treated (%CT) Information.................... 36 6.0 Residential (Non-Occupational) Exposure/Risk Characterization ............................ 36 6.1 Handler.................................................................................................................. 37 6.2 Post-Application ................................................................................................... 37 6.3 Spray Drift............................................................................................................ 38 7.0 Aggregate Risk Assessments and Risk Characterization............................................ 39 7.1 Acute Aggregate Risk........................................................................................... 39 7.2 Short- and Intermediate-Term Aggregate Risk..................................................... 39 7.3 Long-Term Aggregate Risk .................................................................................. 39 7.4 Cancer Risk........................................................................................................... 40 8.0 Cumulative Risk Characterization/Assessment........................................................... 40 9.0 Occupational Exposure/Risk Pathway.......................................................................... 40 9.1 Short- and Intermediate-Term Handler Risk ........................................................ 40 9.2 Short- and Intermediate-Term Post-Application Risk .......................................... 45 10.0 Data Needs and Label Requirements............................................................................ 47 10.1 Toxicology ............................................................................................................ 47 10.2 Residue Chemistry................................................................................................ 47 10.3 Occupational and Residential Exposure ............................................................... 47 References:................................................................................................................................... 48 Appendix A: Toxicology Assessment ....................................................................................... 49 A.1 Toxicology Data Requirements ............................................................................ 49 A.2 Toxicity Profiles.................................................................................................... 50 A.3 Executive Summaries............................................................................................ 54 A.4 References………………………………………………………………………..67 Appendix
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