United States Prevention, Pesticides EPA 738-R-09-304 Environmental Protection and Toxic Substances May 2009 Agency (7508P) Reregistration Eligibility Decision (RED) for Coppers Revised May 2009 TABLE OF CONTENTS Glossary of Terms and Abbreviations ........................................................................................... v Amendment to the Coppers Reregistration Eligibility Decision .............................................. 1 EXECUTIVE SUMMARY .......................................................................................................... 8 II. Chemical Overview............................................................................................................. 15 A. Regulatory History.......................................................................................................... 15 B. Chemical Identification .................................................................................................. 15 C. Use Profile........................................................................................................................ 18 D. Estimated Usage of Copper Pesticides .......................................................................... 21 III. Summary of Coppers Risk Assessments........................................................................... 25 A. Human Health Risk Assessment.................................................................................... 25 1. Background on Copper .............................................................................................. 26 2. Exposure Sources of Copper...................................................................................... 26 3. Human Metabolism of Copper .................................................................................. 27 4. Toxicity Summary for Copper................................................................................... 27 5. FQPA Safety Factor Considerations......................................................................... 31 6. Aggregate Risk from Coppers (Dietary and Residential) ....................................... 32 7. Occupational Exposure .............................................................................................. 32 8. Incidence Data on Copper Exposure......................................................................... 33 B. Ecological Risk Assessment............................................................................................ 33 1. Environmental Fate .................................................................................................... 34 2. Ecological Exposure and Risk.................................................................................... 35 3. Ecological Incidents .................................................................................................... 59 A. Determination of Reregistration Eligibility ..................................................................... 61 B. Public Comments and Responses .................................................................................. 61 C. Regulatory Position......................................................................................................... 62 1. FQPA Findings............................................................................................................ 62 2. Endocrine Disruptor Effects ...................................................................................... 63 3. Cumulative Risks ........................................................................................................ 63 4. Endangered Species .................................................................................................... 64 D. Tolerance Reassessment Summary ............................................................................... 64 1. Tolerances Proposed to be Revoked.......................................................................... 64 2. Tolerances Listed Under 40 CFR §180.1021 ............................................................ 65 E. Regulatory Rationale...................................................................................................... 66 1. Human Health Risk Management............................................................................. 66 2. Ecological Risk Management for Non-target Organisms ....................................... 68 3. Urban Uses................................................................................................................... 78 4. Advisory Language ..................................................................................................... 80 5. 303(d) - Designated Impaired Water Bodies ............................................................ 81 V. What Registrants Need to Do............................................................................................. 86 A. Manufacturing-Use Products......................................................................................... 86 1. Generic Data Requirements....................................................................................... 86 2. Labeling for Manufacturing-Use Products .............................................................. 86 B. End-Use Products........................................................................................................ 86 1. Additional Product-Specific Data Requirements..................................................... 86 ii C. Labeling Changes Summary Table ............................................................................... 88 APPENDIX A. ........................................................................................................................... 100 APPENDIX B. ........................................................................................................................... 106 APPENDIX C. ........................................................................................................................... 112 APPENDIX D. ........................................................................................................................... 113 APPENDIX E. ........................................................................................................................... 122 APPENDIX F. ........................................................................................................................... 123 APPENDIX G............................................................................................................................ 148 iii Coppers Reregistration Eligibility Decision Team Office of Pesticide Programs Antimicrobials Division Diane Isbell Kathryn Jakob Biological and Economic Analysis Division Andrew Lee Jenna Carter Richard Michell William Phillips, II, Ph.D. Environmental Fate and Effects Division James Hetrick, Ph.D. Paige Doelling Brown, Ph.D. Health Effects Division Alan Nielsen Christina Jarvis Elissa Reaves Registration Division Tony Kish Risk Management Rosanna Louie Kevin Costello Neil Anderson Office of General Counsel Andrew Simons iv Glossary of Terms and Abbreviations ai Active Ingredient aPAD Acute Population Adjusted Dose APHIS Animal and Plant Health Inspection Service ARTF Agricultural Re-entry Task Force BCF Bioconcentration Factor CDC Centers for Disease Control CDPR California Department of Pesticide Regulation CFR Code of Federal Regulations ChEI Cholinesterase Inhibition CMBS Carbamate Market Basket Survey cPAD Chronic Population Adjusted Dose CSFII USDA Continuing Surveys for Food Intake by Individuals CWS Community Water System DCI Data Call-In DEEM Dietary Exposure Evaluation Model DL Double layer clothing {i.e., coveralls over SL} EC Emulsifiable Concentrate Formulation EDSP Endocrine Disruptor Screening Program EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. EP End-Use Product EPA U.S. Environmental Protection Agency EXAMS Tier II Surface Water Computer Model FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FOB Functional Observation Battery FQPA Food Quality Protection Act FR FederalRegister GL With gloves IDFS Incident Data System IPM Integrated Pest Management RED Reregistration Eligibility Decision LADD Lifetime Average Daily Dose LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause death in 50% of test animals, usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm. LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of substance per unit weight of animal, e.g., mg/kg. LOAEC Lowest Observed Adverse Effect Concentration LOAEL Lowest Observed Adverse Effect Level LOC Level of Concern LOEC Lowest Observed Effect Concentration mg/kg/day Milligram Per Kilogram Per Day MOE Margin of Exposure MP Manufacturing-Use Product MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted. MRL Maximum Residue Level N/A Not Applicable NASS National Agricultural Statistical Service NAWQA USGS National Water Quality Assessment v NG No Gloves NMFS National Marine Fisheries Service NOAEC No Observed Adverse Effect Concentration