Pesticides EPA 738-R-06-008 Environmental Protection and Toxic Substances April 2006 Agency (7508P)
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Simazine RED April 6, 2006 United States Prevention, Pesticides EPA 738-R-06-008 Environmental Protection and Toxic Substances April 2006 Agency (7508P) Reregistration Eligibility Decision for Simazine Page 1 of 266 Reregistration Eligibility Decision (RED) Document for Simazine List A Case Number 0070 Approved by: Date: April 6, 2006 Debra Edwards, Ph. D. Director Special Review and Reregistration Division Page 2 of 266 Table of Contents Simazine Reregistration Eligibility Decision Team ................................................................... 5 Glossary of Terms and Abbreviations ........................................................................................ 6 Abstract.......................................................................................................................................... 8 I. Introduction............................................................................................................................... 9 II. Chemical Overview................................................................................................................ 10 A. Chemical Identity ................................................................................................................10 B. Use and Usage Profile .........................................................................................................11 C. Tolerances............................................................................................................................12 III. Summary of Risk Assessments ............................................................................................ 13 A. Human Health Risk Assessment ........................................................................................13 1. Hazard Profile ................................................................................................................. 13 2. Dietary Exposure and Risk from Food......................................................................... 18 3. Dietary Exposure and Risk from Drinking Water...................................................... 19 4. Residential Exposure and Risk...................................................................................... 24 5. Aggregate Exposure and Risk........................................................................................ 25 6. Occupational Exposure and Risk.................................................................................. 26 a. Handler Exposure and Risk....................................................................................... 26 b. Post-Application Exposure and Risk ........................................................................ 30 7. Human Incident Summary............................................................................................. 31 B. Ecological Risk Assessment ................................................................................................31 1. Environmental Fate and Transport .............................................................................. 33 2. Aquatic Organism Exposure and Risk ......................................................................... 34 3. Terrestrial Organism Exposure and Risk.................................................................... 37 4. Risk to Endangered Species........................................................................................... 40 5. Ecological Incident Summary ........................................................................................ 41 IV. Risk Management and Reregistration Decision ................................................................ 42 A. Determination of Reregistration Eligibility......................................................................42 B. Public Comments and Responses.......................................................................................43 C. Regulatory Position.............................................................................................................43 1. Food Quality Protection Act Findings .......................................................................... 43 a. "Risk Cup" Determination........................................................................................ 43 b. Determination of Safety to U.S. Population (Including Infants and Children) .... 44 c. Endocrine Disruptor Effects ...................................................................................... 44 d. Cumulative Risks ........................................................................................................ 45 2. Tolerance Summary........................................................................................................ 46 D. Regulatory Rationale ..........................................................................................................49 1. Human Health Risk Management and Mitigation...................................................... 49 a. Dietary Risk Mitigation (Food and Drinking Water).............................................. 49 i. Simazine Surface Water CWS Monitoring Program........................................... 51 ii. Revised Model Concentrations and Additional Confirmatory Data Needs ...... 55 b. Residential Risk Mitigation ....................................................................................... 55 c. Aggregate Risk Mitigation ......................................................................................... 56 d. Occupational Risk Mitigation.................................................................................... 56 2. Environmental Risk Management and Mitigation...................................................... 57 Page 3 of 266 3. Other Labeling Requirements ....................................................................................... 58 4. Threatened and Endangered Species Considerations ................................................. 58 V. What Registrants Need to Do................................................................................................ 59 A. Manufacturing-Use Products .............................................................................................59 1. Additional Generic Data Requirements........................................................................ 59 2. Labeling for Manufacturing-Use Products .................................................................. 61 B. End-Use Products ................................................................................................................61 1. Additional Product-Specific Data Requirements ......................................................... 61 2. Labeling for End-Use Products ..................................................................................... 61 VI. Appendices............................................................................................................................ 78 Appendix A. Simazine Uses and Use-Patterns Eligible for Reregistration ........................79 Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision .....................................................................................83 Appendix C. Technical Support Documents .........................................................................90 Appendix D. Citations Considered to be Part of the Database Supporting the Reregistration Decision (Bibliography) ..........................................................93 Appendix E. Generic Data Call-In (GDCI) .........................................................................249 Appendix F. Product-Specific Data Call-In (PDCI) ...........................................................250 Appendix G. EPA’s Batching of Simazine Products for Meeting Acute Data Requirements for Reregistration...................................................................251 Appendix H. List of Registrants Sent this Data Call-In Notice .........................................255 Appendix I. List of Available Related Documents and Electronically Available Forms 257 Appendix J. Letter to Amend Terms and Conditions of MUP Registrations ..................261 Page 4 of 266 Simazine Reregistration Eligibility Decision Team EPA Office of Pesticide Programs Special Review and Reregistration Division Diane Sherman Bonnie Adler Anne Overstreet Robert McNally Health Effects Division David Soderberg John Liccione Jose Morales Steven Weiss Wade Britton Cathy Eiden Environmental Fate and Effects Division Anita Pease Mary Frankenberry Thuy Nguyen Biological and Economic Analysis Division Bill Phillips Jenna Carter Monisha Kaul Nicole Zinn Stephen Smearman Steve Jarboe Timothy Kiely Arnet (Skee) Jones Registration Division Hope Johnson Jim Tompkins Page 5 of 266 Glossary of Terms and Abbreviations AGDCI Agricultural Data Call-In ai Active Ingredient aPAD Acute Population Adjusted Dose BCF Bioconcentration Factor CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose CSF Confidential Statement of Formulation CSFII USDA Continuing Surveys for Food Intake by Individuals DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration EEC Estimated Environmental Concentration EPA Environmental Protection Agency EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug,