Table of Contents: Regulatory Impact Analysis

  TABLE OF CONTENTS                                                        Page
List of Figures  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-1   
I.    INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1    
    A.   Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1   
    B.   Current Policy and the Final Rule . . . . . . . . . . . . . . . . I-3    
    C.   Overview of Regulatory Requirements . . . . . . . . . . . . . . . I-6    
    D.   Structure of the RIA. . . . . . . . . . . . . . . . . . . . . . . I-11       
II.    THE REGULATED COMMUNITY . . . . . . . . . . . . . . . . . . . . . . II-1    
    A.   Overview of Microbial Applications Subject to TSCA. . . . . . . . II-1    
    B.   Biotechnology Industry Overview . . . . . . . . . . . . . . . . . II-2    
    C.   University Research . . . . . . . . . . . . . . . . . . . . . . . II-12 
III.    BENEFITS OF THE FINAL RULE . . . . . . . . . . . . . . . . . . . . III-1    
    A.   Overview of Risks of Novel Microorganisms . . . . . . . . . . . . III-1    
    B.   Risk Reduction from Microbial Regulation. . . . . . . . . . . . . III-3    
    C.   Qualitative Assessment of Incremental Benefits. . . . . . . . . . III-8  
IV.    INDUSTRY COSTS. . . . . . . . . . . . . . . . . . . . . . . . . . . IV-1    
    A.   Overview of Industry Cost Methodology and Results . . . . . . . . IV-1    
    B.   Types and Numbers of Microbial Submissions to EPA . . . . . . . . IV-6
    C.   Unit Costs of MCANs, Tier I and II Exemptions,
          and TERAs . . . . . . . . . . . . . . . . . . . .  . . . . . . . IV-10
    D.   Post Review Monitoring, Reporting, and Controls . . . . . . . . . IV-23
    E.   Other Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-25
    F.   Per Product Costs of Reporting and Controls . . . . . . . . . . . IV-36
    G.   Costs of Regulatory Alternatives and Sensitivity
          Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-36
V.    GOVERNMENT COSTS . . . . . . . . . . . . . . . . . . . . . . . . . . V-1
    A.   Overview of EPA Cost Methodology. . . . . . . . . . . . . . . . . V-1
    B.   Peer Review Advisory Committee Costs. . . . . . . . . . . . . . . V-3
    C.   Review Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . V-6
    D.   Baseline Costs. . . . . . . . . . . . . . . . . . . . . . . . . . V-13
    E.   Incremental Costs to EPA for the Final Rule . . . . . . . . . . . V-13  
VI.    EFFECTS OF THE FINAL RULE ON INNOVATIVE ACTIVITY. . . . . . . . . . VI-1
    A.   The Final Rule's Effects on Innovation  . . . . . . . . . . . . . VI-1
    B.   Links Between Regulatory Burdens And Innovative
          Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . VI-5
    C.   Summary of Considerations . . . . . . . . . . . . . . . . . . . . VI-7 
VII.    INTERNATIONAL CONSIDERATIONS . . . . . . . . . . . . . . . . . . . VII-1
    A.   Introduction  . . . . . . . . . . . . . . . . . . . . . . . . . . VII-1
    B.   Effects of the Final Rule on International
          Competitiveness  . . . . . . . . . . . . . . . . . . . . . . . . VII-1
VIII.    EFFECTS OF THE PROPOSED RULE ON SMALL BUSINESSES. . . . . . . . . VIII-1
    A.   Small Business Impact Analysis  . . . . . . . . . . . . . . . . . VIII-1
    B.   Regulatory Flexibility Analysis . . . . . . . . . . . . . . . . . VIII-6
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R-1  

APPENDICES

APPENDIX A: RESULTS OF ICF BIOTECHNOLOGY SURVEY. . . . . . . . . . . . . . A-1
APPENDIX B: SUMMARY OF INFORMATION COLLECTED FROM TELEPHONE
         CONVERSATIONS WITH INDUSTRY REPRESENTATIVES AND
         UNIVERSITY RESEARCHERS. . . . . . . . . . . . . . . . . . . . . . B-1
APPENDIX C: NUMBERS OF SUBMISSIONS . . . . . . . . . . . . . . . . . . . . C-1
APPENDIX D: INDUSTRY COST CALCULATIONS AND OPTIONS/
         SENSITIVITY ANALYSES. . . . . . . . . . . . . . . . . . . . . . . D-1
APPENDIX E: CONFIDENTIAL BUSINESS INFORMATION  . . . . . . . . . . . . . . E-1
APPENDIX F: REGULATORY COSTS ON A PER-PRODUCT BASIS. . . . . . . . . . . . F-1
APPENDIX G: DEVELOPMENT COSTS AND EXPECTED RETURNS . . . . . . . . . . . . G-1
APPENDIX H: COST MEMORANDA FOR DETERMINING EPA PER SUBMISSION. . . . . . . H-5
APPENDIX I: INTERNATIONAL REGULATION OF GENETICALLY MODIFIED 
         MICROORGANISMS