CONTENTS 
Pag# 
Summary of Findings and Recommendations vii 
Introduction ■ 1 
Part I. Principal Findings 5 
Actual and Potential Benefits 5 
The Technique and Its Scientific Significance 5 
Applications of Recombinant DNA Technology 6 
Products from Micro-organisms 6 
Other Applications 7 
Service Industry 7 
Potential Hazards 7 
General Concerns 7 
Experiments with E. coli K-12 as the Host Organism 8 
Creation of a Novel Pathogenic E. coli 9 
Transfer of Recombinant DNA from E. coli K-12 to Other 
Organisms 10 
Development of Further Weakened E. coli Hosts and 
Vectors 10 
Use of Other Host-Vector Systems 11 
Other Concerns 12 
Current Federal Regulation of Research 13 
Origin and Provisions of the NIH Guidelines 13 
Effects of the Guidelines 14 
Deficiencies of the Guidelines 16 
Coverage 16 
Procedures 17 
Regulation of Commercial Applications 20 
Part II. Recommendations 23 
Recommendations for Regulation of Research 23 
Legislative Authority 23 
Scope, Implementation and Duration of Legislation 26 
Who Should Regulate 29 
Federal Agency 29 
Advisory System 30 
Role of Institutions Engaged in Research 30 
Role of State and Local Governments 31 
Procedures 35 
Recommendations for Regulation of Commercial Applications 40 
Locus of Regulatory Responsibility 40 
Applicability of Existing Statutes 41 
Prevention of Hazards 43 
Control of Manufacture 45 
Testing Requirements 46 
Recordkeeping and Reporting Requirements 47 
Minority Views of Senator Schmitt 50 
<v) 
[Appendix B — 256] 
