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Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology under the Toxic Substances Control Act (TSCA)

Executive Summary for the Regulatory Imact Analysis
PDF version of Executive Summary for the Regulatory Imact Analysis
Table of Contents
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Chapter I: Introduction
PDF version of Chapter I: Introduction
Chapter II: The Regulated Community
PDF version of Chapter II: The Regulated Community
Chapter III: Benefits of the Final Rule
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Chapter IV: Industry Costs
PDF version of Chapter IV: Industry Costs
Chapter V: Government Costs
PDF version of Chapter V: Government Costs
Chapter VI: Effects of the Final Rule on Innovative Activity
PDF version of Chapter VI: Effects of the Final Rule on Innovative Activity
Chapter VII: International Considerations
PDF version of Chapter VII: International Considerations
Chapter VIII: Effects of the Proposed Rule on Small Businesses
PDF version of Chapter VIII: Effects of the Proposed Rule on Small Businesses
List of References
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Appendix Cover
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Appendix A: Results of ICF Biotechnology Survey
PDF version of Appendix A: Results of ICF Biotechnology Survey
Appendix B: Summary of Information Collected From Telephone Conversations With Industry Representatives and University Researchers
PDF version of Appendix B: Summary of Information Collected From Telephone Conversations With Industry Representatives and University Researchers
Appendix C: Numbers of Submissions
PDF version of Appendix C: Numbers of Submissions
Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses
PDF version of Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses
Appendix E: Confidential Business Information
PDF version of Appendix E: Confidential Business Information
Appendix F: Regulatory Costs on a Per-Product Basis
PDF version of Appendix F: Regulatory Costs on a Per-Product Basis
Appendix G: Development Costs and Expected Returns
PDF version of Appendix G: Development Costs and Expected Returns
Appendix H: Cost Memoranda for Determining EPA Per Submission Reporting Costs and EPA's Review Process
PDF version of Appendix H: Cost Memoranda for Determining EPA Per Submission Reporting Costs and EPA's Review Process
Appendix I: International Regulation of Genetically Modified Microorganisms
PDF version of Appendix I: International Regulation of Genetically Modified Microorganisms

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