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For Formetanate Hydrochloride US Environmental Protection Agency Office of Pesticide Programs Reregistration Eligibility Decision for Formetanate Hydrochloride When EPA concluded the N-methyl carbamate cumulative risk assessment in September 2007, all tolerance reassessment and reregistration eligibility decisions for individual N-methyl carbamate pesticides were considered complete. N-methyl carbamate Interim Reregistration Eligibility Decisions (IREDs), therefore, are considered completed REDs. Combined PDF document consists of the following: • Completion of the Tolerance Reassessment and Final Reregistration Eligibility Decisions for the N-methyl Carbamate Pesticides (September 24, 2007) • Formetanate Hydrochloride IRED United States Prevention, Pesticides Environmental Protection and Toxic Substances March 2006 Agency (7508C) EPA 738-R-06-015 Interim Reregistration Eligibility Decision for Formetanate Hydrochloride Interim Reregistration Eligibility Decision (IRED) Document for Formetanate Hydrochloride Case Number 0091 Approved by: Date: Debra Edwards, Ph. D. Director Special Review and Reregistration Division Table of Contents Formetanate Hydrochloride Interim Reregistration Eligibility Decision Team...................... i Glossary of Terms and Abbreviations ........................................................................................ ii Abstract......................................................................................................................................... iv I. Introduction ............................................................................................................................... 1 II. Chemical Overview.................................................................................................................. 2 A Chemical Identity...................................................................................................................... 2 B Regulatory History............................................................................................................ 3 B. Use and Usage Profile ...........................................................................................................3 III. Summary of Risk Assessment ............................................................................................... 3 A. Human Health Risk Assessment..........................................................................................4 1. Toxicity............................................................................................................................... 4 2. Dietary Exposure and Risk from Food and Drinking Water ....................................... 6 4. Residential Risk................................................................................................................. 8 5. Aggregate Risk .................................................................................................................. 9 6. Occupational Exposure and Risk .................................................................................... 9 7. Human Incident Summary............................................................................................. 12 B. Ecological Risk.....................................................................................................................12 1. Environmental Fate and Transport .............................................................................. 12 Environmental Effects.............................................................................................................13 2. Environmental Effect...................................................................................................... 13 a. Aquatic Organism Risk .............................................................................................. 13 b. Terrestrial Organism Risk......................................................................................... 14 3. Ecological Incidents ........................................................................................................ 15 4. Risk to Endangered Species ........................................................................................... 16 IV. Interim Risk Management, Reregistration, and Tolerance Reassessment Decision...... 16 A. Determination or Reregistration Eligibility .....................................................................16 B. Public Comments and Responses ......................................................................................17 C. Regulatory Position.............................................................................................................17 1. Food Quality Protection Act Findings .......................................................................... 17 a. "Risk Cup" Determination ........................................................................................ 17 c. Endocrine Disruptor Effects ...................................................................................... 18 d. Cumulative Risks........................................................................................................ 18 2. Interim Tolerance Summary ......................................................................................... 18 D. Regulatory Rationale .........................................................................................................19 1. Human Health Risk Management................................................................................. 19 a. Dietary Risk Mitigation (food and drinking water)................................................. 19 b. Residential Risk Mitigation ....................................................................................... 20 c. Occupational Risk Mitigation .................................................................................... 20 2. Ecological Risk Management and Mitigation .............................................................. 22 3. Significance of Formetanate HCl Use ........................................................................... 23 4. Spray Drift....................................................................................................................... 23 5. Endangered Species Considerations ............................................................................. 23 V. What Registrants Need to Do................................................................................................ 24 A. Manufacturing-Use Products.............................................................................................25 1. Additional Generic Data Requirements........................................................................ 25 B. End-Use products ................................................................................................................25 1. Additional Product-Specific Data Requirements......................................................... 25 2. Labeling for End-Use Products ..................................................................................... 25 VI. Appendices ............................................................................................................................ 34 A. Table of Use Patterns for Formetanate.................................Error! Bookmark not defined. C. Technical Support Documents...........................................................................................39 D. Bibliography ........................................................................................................................41 E. Generic Data Call-In...........................................................................................................49 F. Product-Specific Data Call-In ............................................................................................50 G. EPA's Batching of Formetanate HCl Products for Meeting Acute Toxicity Data Requirements for Reregistration............................................................................................... 51 H. List of Registrants Sent Data Call-Ins ..............................................................................52 I. List of Available Related Documents and Electronically Available Forms....................53 Formetanate Hydrochloride Interim Reregistration Eligibility Decision Team Biological and Economics Assessment David Brassard Environmental Fate and Effects Risk Assessment Ibrahim Abdel Saheb Richard Lee Health Effects Risk Assessment Danette Drew John Doherty Susan Stanton Seyed Tadayon Registration Support Dan Kenny Risk Management Demson Fuller Laura Parsons i 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, and Cosmetic Act FQPA Food Quality Protection Act GLN Guideline Number IR Index Reservoir LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
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