SERA TR-052-23-03b Emamectin benzoate Human Health and Ecological Risk Assessment FINAL REPORT Submitted to: Paul Mistretta, COR USDA/Forest Service, Southern Region 1720 Peachtree RD, NW Atlanta, Georgia 30309 USDA Forest Service Contract: AG-3187-C-06-0010 USDA Forest Order Number: AG-43ZP-D-09-0032 SERA Internal Task No. 52-23 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 October 28, 2010 Table of Contents LIST OF TABLES ......................................................................................................................... vi LIST OF FIGURES ....................................................................................................................... vi LIST OF APPENDICES ................................................................................................................ vi ACRONYMS, ABBREVIATIONS, AND SYMBOLS ............................................................... vii COMMON UNIT CONVERSIONS AND ABBREVIATIONS ................................................... ix CONVERSION OF SCIENTIFIC NOTATION ............................................................................ x EXECUTIVE SUMMARY ........................................................................................................... xi 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 ............................................................................................................ 7 2.4. Mixing and Application Rates ........................................................................................... 10 2.5. Use Statistics ...................................................................................................................... 11 2.6. Special Note on Data Limitations and the Treatment of Pine ........................................... 12 3. HUMAN HEALTH .................................................................................................................. 15 3.1. HAZARD IDENTIFICATION ........................................................................................ 15 3.1.1. Overview ..................................................................................................................... 15 3.1.2. Mechanism of Action .................................................................................................. 15 3.1.3. Pharmacokinetics and Metabolism ............................................................................. 16 3.1.3.1. General Considerations ........................................................................................ 16 3.1.3.2. Absorption............................................................................................................ 17 3.1.3.2.1. First-order Dermal Absorption ......................................................................... 17 3.1.3.2.2. Zero-order Dermal Absorption ......................................................................... 19 3.1.3.3. Excretion .............................................................................................................. 20 3.1.4. Acute Oral Toxicity .................................................................................................... 21 3.1.5. Subchronic or Chronic Systemic Toxic Effects .......................................................... 22 3.1.6. Effects on Nervous System ......................................................................................... 23 3.1.7. Effects on Immune System ......................................................................................... 25 3.1.8. Effects on Endocrine System ...................................................................................... 26 3.1.9. Reproductive and Developmental Effects .................................................................. 26 3.1.9.1. Developmental Studies ........................................................................................ 26 3.1.9.2. Reproduction Studies ........................................................................................... 27 3.1.10. Carcinogenicity and Mutagenicity ............................................................................ 27 3.1.11. Irritation and Sensitization (Effects on the Skin and Eyes) ...................................... 28 ii 3.1.12. Systemic Toxic Effects from Dermal Exposure ....................................................... 29 3.1.13. Inhalation Exposure .................................................................................................. 29 3.1.13.1. General Considerations ...................................................................................... 29 3.1.13.2. Combustion of Ash Wood ................................................................................. 29 3.1.14. Adjuvants and Other Ingredients .............................................................................. 30 3.1.15. Impurities and Metabolites ....................................................................................... 31 3.1.15.1. Impurities ........................................................................................................... 31 3.1.15.2. Metabolites ......................................................................................................... 31 3.1.16. Toxicological Interactions ........................................................................................ 32 3.2. EXPOSURE ASSESSMENT .......................................................................................... 33 3.2.1. Overview ..................................................................................................................... 33 3.2.2. Workers ....................................................................................................................... 33 3.2.2.1. General Exposures ............................................................................................... 34 3.2.2.1.1. Studies on Tree-äge ....................................................................................... 34 3.2.2.1.2. Deposition Based Exposure Assessments ..................................................... 34 3.2.2.1.3. Absorption Based Exposure Assessment ...................................................... 36 3.2.2.1.4. Comparison of Methods ................................................................................ 36 3.2.2.2. Accidental Exposures........................................................................................... 38 3.2.3. General Public ........................................................................................................... 39 3.2.3.1. General Considerations ........................................................................................ 39 3.2.3.1.1. Likelihood and Magnitude of Exposure ....................................................... 39 3.2.3.1.2. Summary of Assessments ............................................................................. 40 3.2.3.2. Direct Spray ......................................................................................................... 40 3.2.3.3. Dermal Exposure from Contaminated Vegetation ............................................... 41 3.2.3.4. Contaminated Water ............................................................................................ 41 3.2.3.5. Oral Exposure from Contaminated Fish .............................................................. 44 3.2.3.6. Dermal Exposure from Swimming in Contaminated Water ................................ 44 3.2.3.6. Oral Exposure from Contaminated Vegetation.................................................... 45 3.3. DOSE-RESPONSE ASSESSMENT ................................................................................. 49 3.3.1. Overview ..................................................................................................................... 49 3.3.2. Acute RfD ................................................................................................................... 49 3.3.3. Chronic RfD ................................................................................................................ 50 3.3.4. Surrogate RfD for Occupational Exposures ............................................................... 51 3.3.5. Dose-Severity Relationships ....................................................................................... 52 iii 3.4. RISK CHARACTERIZATION ....................................................................................... 54 3.4.1. Overview ..................................................................................................................... 54 3.4.2. Workers ......................................................................................................................