SERA TR-056-16-03b Spinosad: Human Health and Ecological Risk Assessment FINAL REPORT Submitted to: Dr. Harold Thistle USDA Forest Service Forest Health Technology Enterprise Team 180 Canfield St. Morgantown, WV 26505 Email: [email protected] USDA Forest Service Contract: AG-3187-C-12-0009 USDA Forest Order Number: AG-3187-D-15-0076 SERA Internal Task No. 56-16 Submitted by: Patrick R. Durkin Syracuse Environmental Research Associates, Inc. 8125 Solomon Seal Manlius, New York 13104 E-Mail: [email protected] Home Page: www.sera-inc.com September 24, 2016 Table of Contents LIST OF TABLES ........................................................................................................................ vii LIST OF FIGURES ..................................................................................................................... viii LIST OF APPENDICES .............................................................................................................. viii ACRONYMS, ABBREVIATIONS, AND SYMBOLS ................................................................ ix COMMON UNIT CONVERSIONS AND ABBREVIATIONS .................................................. xii CONVERSION OF SCIENTIFIC NOTATION ......................................................................... xiii EXECUTIVE SUMMARY ......................................................................................................... xiv 1. INTRODUCTION ...................................................................................................................... 1 1.1. Chemical Specific Information ............................................................................................ 1 1.2. General Information ............................................................................................................. 2 2. PROGRAMS DESCRIPTION ................................................................................................... 5 2.1. Overview .............................................................................................................................. 5 2.2. Chemical Description and Commercial Formulations ......................................................... 5 2.3. Application Methods ............................................................................................................ 8 2.4. Mixing and Application Rates ............................................................................................. 8 2.5. Use Statistics ........................................................................................................................ 9 3. HUMAN HEALTH .................................................................................................................. 12 3.1. HAZARD IDENTIFICATION ........................................................................................ 12 3.1.1. Overview ..................................................................................................................... 12 3.1.2. Mechanism of Action .................................................................................................. 12 3.1.3. Pharmacokinetics and Metabolism ............................................................................. 13 3.1.3.1. Distribution and Metabolism ............................................................................... 13 3.1.3.2. Dermal Absorption............................................................................................... 14 3.1.3.2.1. First-Order Dermal Absorption..................................................................... 14 3.1.3.2.2. Zero-Order Dermal Absorption .................................................................... 15 3.1.3.3. Excretion .............................................................................................................. 16 3.1.4. Acute Oral Toxicity .................................................................................................... 17 3.1.4.1. Standard Registrant Studies ................................................................................. 17 3.1.4.2. Other Data ............................................................................................................ 18 3.1.5. Subchronic or Chronic Systemic Toxic Effects .......................................................... 19 3.1.6. Effects on Nervous System ......................................................................................... 21 3.1.7. Effects on Immune System ......................................................................................... 22 3.1.8. Effects on Endocrine System ...................................................................................... 22 3.1.9. Reproductive and Developmental Effects .................................................................. 24 3.1.9.1. Developmental Studies ........................................................................................ 24 3.1.9.2. Reproduction Studies ........................................................................................... 24 3.1.10. Carcinogenicity and Mutagenicity ............................................................................ 25 ii 3.1.11. Irritation and Sensitization (Effects on the Skin and Eyes) ...................................... 26 3.1.11.1. Skin Irritation ..................................................................................................... 26 3.1.11.2. Skin Sensitization............................................................................................... 26 3.1.11.3. Ocular Effects .................................................................................................... 27 3.1.12. Systemic Toxic Effects from Dermal Exposure ....................................................... 27 3.1.13. Inhalation Exposure .................................................................................................. 28 3.1.14. Adjuvants and Other Ingredients .............................................................................. 29 3.1.14.1. Other Ingredients ............................................................................................... 29 3.1.14.2. Adjuvants ........................................................................................................... 30 3.1.15. Impurities and Metabolites ....................................................................................... 30 3.1.15.1. Metabolites ......................................................................................................... 30 3.1.15.2. Impurities ........................................................................................................... 31 3.1.16. Toxicologic Interactions ........................................................................................... 31 3.2. EXPOSURE ASSESSMENT .......................................................................................... 33 3.2.1. Overview ..................................................................................................................... 33 3.2.2. Workers ....................................................................................................................... 33 3.2.2.1. General Exposures ............................................................................................... 33 3.2.2.2. Accidental Exposures........................................................................................... 34 3.2.3. General Public ........................................................................................................... 35 3.2.3.1. General Considerations ........................................................................................ 35 3.2.3.1.1. Likelihood and Magnitude of Exposure ....................................................... 35 3.2.3.1.2. Summary of Assessments ............................................................................. 36 3.2.3.2. Direct Spray ......................................................................................................... 37 3.2.3.3. Dermal Exposure from Contaminated Vegetation ............................................... 37 3.2.3.4. Contaminated Water ............................................................................................ 38 3.2.3.4.1. Accidental Spill ............................................................................................. 38 3.2.3.4.2. Accidental Direct Spray/drift for a Pond or Stream ...................................... 38 3.2.3.4.3. GLEAMS Modeling...................................................................................... 39 3.2.3.4.4. Other Modeling Efforts ................................................................................. 40 3.2.3.4.5. Monitoring Data ............................................................................................ 41 3.2.3.4.6. Concentrations in Water Used for Risk Assessment .................................... 42 3.2.3.5. Oral Exposure from Contaminated Fish .............................................................. 42 3.2.3.6. Dermal Exposure from Swimming in Contaminated Water ................................ 43 3.2.3.7. Oral Exposure from Contaminated Vegetation.................................................... 44 3.3. DOSE-RESPONSE ASSESSMENT ................................................................................. 47 3.3.1. Overview ....................................................................................................................