38048 
Federal Register / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Ouldellnes for Research Involving 
Recombinant DNA Molecules 
Table of Contents 
I. Scope of the Guidelines 
I-A — Purpose 
I-B — Definition of Recombinant DNA 
Molecules 
I-C — General Applicability 
1-D — General Definitions 
n. Containment 
III. Containment Guidelines for Covered 
Experiments 
ni-A — Experiments that Require RAC 
Review and NIH and IBC Approval 
Before Initiation 
III-B — Experiments that Require IBC 
Approval Before Initiation 
III-^l — Experiments Using Human or 
Animal Pathogens (Class 2, Class 3, 
Class 4, or Class 5 Agents) as Host- 
Vector Systems 
III-B-2 — Experiments in which DNA from 
Human or Animal Pathogens (Class 2, 
Class 3, Class 4, or Class 5 Agents] is 
Cloned in Nonpathogenic Prokaryotic or 
Lower Eukaryotic Host-Vector Systems 
III-B-3 — Experiments Involving the Use of 
Infectious Animal or Plant Viruses or 
Defective Animal or Plant Viruses in the 
Presence of Helper Virus in Tissue 
Culture Systems 
lII-B-4 — Recombinant DNA Experiments 
Involving Whole Animals or Plants 
III-B-5 — Experiments Involving More than 
10 Liters of Culture 
III-C — Experiments that Require IBC 
Notice Simultaneously with Initiation of 
Experiments 
III- D — Exempt Experiments 
rV. Roles and Responsibilities 
IV- A — Policy 
rV-B — Responsibilities of the Institution 
IV-B-1 — General Information 
rV-B-2 — Membership and Procedures of 
the IBC 
rV-B-3 — Functions of the IBC 
rV-B-4 — Biological Safety Officer 
IV-B-5 — Principal Investigator 
IV-B-5-a — PI— General 
IV-B-5-b — Submissions by the PI to NIH 
IV-B-5-C — Submissions by the PI to the 
IBC 
IV-B-5-d — PI Responsibilities Prior to 
Initiating Research 
IV-B-5-e — PI Responsibilities During the 
Conduct of the Research 
IV-C — Responsibilities of NIH 
IV-C-1 — Director 
IV-C-l-a — General Responsibilities of the 
Director, NIH 
rV^C-l-b — Specific Responsibilities of the 
Director, NIH 
IV-C-2 — Recombinant DNA Advisory 
Committee 
IV-C-3 — The Office of Recombinant DNA 
Activities 
IV-C-4 — Other NIH Components 
IV-D — Compliance 
V. Footnotes and References of Sections I-IV 
VI. Voluntary Compliance 
VI-A — Basic Poiicy 
VI-B — IBC Approval 
VI-C — Certification of Host-Vector 
Systems 
VI-D — Requests for Exemptions and 
Approvals 
VI-E— Protection of Proprietary Date 
Appendix A. Exemptions Under III-D-4 
Appendix B. Classification of 
Microorganisms on the Basis of Hazard 
Appendix B-I — Classification of Etiologic 
Agents 
Appendix B-l-A — Class 1 Agents 
Appendix B-I-B — Class 2 Agents 
Appendix B-I-B-1 — Bacterial Agents 
Appendix B-I-B-2 — Fungal Agents 
Appendix B-I-B-3 — Parasitic Agents 
Appendix B-I-B-4 — Viral, Rickettsial, and 
Chlamydial Agents 
Appendix B-I-C— -Class 3 Agents 
Appendix B-I-C-1 — Bacterial Agents 
Appendix B-I-C-2 — Fungal Agents 
Appendix B-I-C-3 — Parasitic ^ents 
Appendix B-I-C-4 — Viral, Rickettsial, and 
Chlamydial Agents 
Appendix B-I-D — Class 4 Agents 
Appendix B-I-D-1 — Bacterial Agents 
Appendix B-I-D-2 — Fungal Agents 
Appendix B-l-D-3 — Parasitic Agents 
Appendix B-I-D-4 — Viral, Rickettsial, and 
Chlamydial Agents 
Appendix B-II — Classification of 
Oncogenic Viruses on the Basis of 
Potential Hazard 
Appendix B-II-A — Low Risk Oncogenic 
Viruses 
Appendix B-II-B — Moderate-Risk 
Oncogenic Viruses 
Appendix B-III — Class 5 Agents 
Appendix B-IU-A — Animal Disease 
Organisms Which are Forbidden Entry 
into the United States by Law 
Appendix B-UI-B — Animal Disease 
Organisms and Vectors Which are 
Forbidden Entry into the United States 
by USDA Policy 
Appendix B-III-C — Organisms Which May 
Not Be Studied in the United States 
Except At Specified Facilities 
Appendix B-IV — ^Footnotes and References 
of Appendix B 
Appendix C. Exemptions Under III-D-5 
Appendix C-I — Recombinant DNAs in 
Tissue Culture 
Appendix C-II — Experiments Involving E. 
coli K-12 Host-Vector Systems 
Appendix C-III — Experiments Involving 
Saccharomyces cerevisiae Host-Vector 
Systems 
Appendix C-IV — Experiments Involving 
Bacillus subtilis Host- Vector Systems 
Appendix C-V — Footnotes and References 
of Appendix C 
Appendix D. Actions Taken Under the 
Guidelines 
Appendix E. Certified Host-Vector Systems 
Appendix F. Containment Conditions for 
Cloning of Genes Coding for the 
Biosynthesis of Molecules Toxic for 
Vertebrates 
Appendix F-I — General Information 
Appendix F-II — Containment Conditions 
for Cloning of Toxic Molecule Genes in 
E. coli K-12 
Appendix F-III — Containment Conditions 
for Cloning of Toxic Molecule Genes in 
Organisms Other than E. coli K-12 
Appendix F-IV — Specific Approvals 
[2] 
Appendix G. Physical Containment 
Appendix G-I — Standard Practices and 
Training 
Appendix G-II — Physical Containment 
Levels 
Appendix G-II-A — PI Level 
Appendix G-II-A-1 — Laboratory Practices 
Appendix G-Il-A-2 — Containment 
Equipment 
Appendix G-II-A-3 — Special Laboratory 
Design 
Appendix G-II-B — P2 Level 
Appendix G-II-B-1 — Laboratory Practices 
Appendix G-II-B-2 — Containment 
Equipment 
Appendix G-II-B-3 — Special Laboratory 
Design 
Appendix G-II-C — P3 Level 
Appendix G-II-C-1 — Laboratory Practices 
Appendix G-II-C-2 — Containment 
Equipment 
Appendix G-II-C-3 — Special Laboratory 
Design 
Appendix G-II-D — P4 Level 
Appendix G-II-D-1 — Laboratory Practices 
Appendix G-U-D-2 — Containment 
Equipment 
Appendix G-U-D-3 — Special Laboratory 
Design 
Appendix G-III — Footnotes and References 
of Appendix G 
Appendix H. Shipment 
Appendix I. Biological Containment 
Appendix I-I — Levels of Biological 
Containment 
Appendix I-I-A — HVl 
Appendix I-I-A-1 — EKl 
Appendix I-I-A-2 — Other HVl 
Appendix I-I-B — HV2 
Appendix I-Il — CertiHcation of Host- 
Vector Systems 
Appendix I-Il-A — Responsibility 
Appendix I-II-B — Data To Be Submitted 
for Certification 
Appendix I-Il-B-1 — HVl Systems Other 
than E. coli K-12 
Appendix I-U-B-2 — ^HV2 Systems 
Appendix I-III — Footnotes and References 
of Appendix I 
Appendix J. Federal Interagency Advisory 
Committee on Recombinant DNA 
Research 
I. Scope of the Guidelines 
I-A. Purpose. The purpose of these 
Guidelines is to specify practices for 
constructing and handling (i) 
recombinant DNA molecules and (ii) 
organisms and viruses containing 
recombinant DNA molecules. 
I-B. Definition of Recombinant DNA 
Molecules. In the context of these 
Guidelines, recombinant DNA molecules 
are defined as either (i) molecules which 
are constructed outside living cells by 
joining natural or synthetic DNA 
segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA 
molecules that result from the 
replication of those described in (i) 
above. 
Synthetic DNA segments likely to 
yield a potentially harmful 
i' 
