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

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Executive Summary for the Regulatory Imact Analysis
PDF version of Executive Summary for the Regulatory Imact Analysis (PDF) (12 pp, 29K)

Table of Contents
PDF version of Table of Contents (PDF) (14 pp, 50K)

Chapter I: Introduction
PDF version of Chapter I: Introduction (PDF) (8 pp, 26K)

Chapter II: The Regulated Community
PDF version of Chapter II: The Regulated Community (PDF) (14 pp, 35K)

Chapter III: Benefits of the Final Rule
PDF version of Chapter III: Benefits of the Final Rule (PDF) (12 pp, 32K)

Chapter IV: Industry Costs
PDF version of Chapter IV: Industry Costs (PDF) (43 pp, 678K)

Chapter V: Government Costs
PDF version of Chapter V: Government Costs (PDF) (19 pp, 46K)

Chapter VI: Effects of the Final Rule on Innovative Activity
PDF version of Chapter VI: Effects of the Final Rule on Innovative Activity (PDF) (8 pp, 261K)

Chapter VII: International Considerations
PDF version of Chapter VII: International Considerations (PDF) (12 pp, 34K)

Chapter VIII: Effects of the Proposed Rule on Small Businesses
PDF version of Chapter VIII: Effects of the Proposed Rule on Small Businesses (PDF) (12 pp, 32K)

List of References
PDF version of List of References (PDF) (12 pp, 36K)

Appendix Cover
PDF version of Appendix Cover (PDF) (1 pg, 18K)

Appendix A: Results of ICF Biotechnology Survey
PDF version of Appendix A: Results of ICF Biotechnology Survey (PDF) (49 pp, 924K)

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 (PDF) (12 pp, 38K)

Appendix C: Numbers of Submissions
PDF version of Appendix C: Numbers of Submissions (PDF) (12 pp, 34K)

Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses
PDF version of Appendix D: Industry Cost Calculations and Options/Sensitivity Analyses (PDF) (43 pp, 549K)

Appendix E: Confidential Business Information
PDF version of Appendix E: Confidential Business Information (PDF) (11 pp, 353K)

Appendix F: Regulatory Costs on a Per-Product Basis
PDF version of Appendix F: Regulatory Costs on a Per-Product Basis (PDF) (27 pp, 311K)

Appendix G: Development Costs and Expected Returns
PDF version of Appendix G: Development Costs and Expected Returns (PDF) (5 pp, 18K)

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 (PDF) (20 pp, 807K)

Appendix I: International Regulation of Genetically Modified Microorganisms
PDF version of Appendix I: International Regulation of Genetically Modified Microorganisms (PDF) (22 pp, 75K)


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