6958 
Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 1936 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Guidelines for Research Involving 
Recombinant DNA Molecules 
Way 1S86. 
These N1H Guidelines supersede 
earlier versions and will be in effect 
until further notice. 
Table of Contents 
I. Scope of Guidelines 
I-A — Purpose 
I-B — Definition of Recombinant DMA 
Molecules 
1-C — General Applicability 
I-D — General Definitions 
II. Containment 
III. Guidelines for Covered Experiments 
III— A — Experiments that Require RAC 
Review and NIH and IDC Approval 
Before Initiation 
III— B — Experiments that Require IBC 
Approval Before Initiation 
M-B-l — Experiments Using Human or 
Animal Pathogens (Class 2, Class 3. 
Class 4. or Class 5 Agents) as Host- 
Vector S> stems 
III-B-2 — Experiments in Which DMA from 
Human or Animal Pathogens (Class 2, 
Class 3, Class 4, or Class 5 Agents) is 
Cloned in Nonpathoger.ic Prokaryotic or 
Lower Eukaryotic Host-Vector Systems 
III— 3— 3 — Experiments Involving the Use of 
Infectious Animal or Plant DNA or RMA 
Viruses or Defective Animal or Plant 
DNA or RNA Viruses in the Presence of 
Helper Vims in Tissue Culture Systems 
III— 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 
UI-D— Exempt Experiments 
IV. Roles and Responsibilities 
IV- A — Policy 
IV-B — Responsibilities cf the Institution 
IV-B-1 — General Information 
IV-B-2 — Membership and Procedures of 
the IBC 
IV-B-3 — Functions of the IBC 
IV-E-4 — Biological Safety Officer 
IV-B-5 — Principal Investigator (PI) 
IV-B-5-a — PI — General 
IV-B-S-b — Submission by tha 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 
FV-C-l-b — Specific Responsibilities of the 
Director. NIH 
IV-C-2 — Recombinant DNA Advisory 
Committee 
IV-C-3 — Office of Recombinant DNA 
Activities 
IV-C— 4 — Other NIH Components 
[ 2 ] 
IV-D — Compliance 
V. Footnotes and References of Sections I— IV 
VL Voluntary Compliance 
VT-A — Basic Policy 
VI-B — !BC Approval 
VI-C — Certification of Host-Vector 
Systems 
VI-D — Requests for Exemptions and 
Approvals 
Vl-E — Protection of Proprietary Data 
Appendix A. Exemptions Under UI-D— 1 
Appendix B. Classification of 
Microorganisms on the Basis of Hazard 
Appendix B-I — Classification of Etiologic 
Agents 
Appendix B-I-A — Class 1 Agents 
Appendix B-i-B— Class 2 Agents 
Appendix B-I-B-l — Bacterial Agents 
Appendix B-l-B-2 — Fungal Agents 
Appendix 3-I-B-3 — Parasitic Agents 
Appendix 3-I-B-4 — Viral. Rickettsial, and 
Chlamydial Agents 
Appendix B-I-C — Class 3 Agents 
Appendix B-I-C-l — Bacterial Agents 
Appendix E-I-C-2 — Fungal Agents 
Appendix B-I-C- 3 — Parasitic Agents 
Appendix B-I-C-4 — Viral. Rickettsial, and 
Chlamydial Agents 
Appendix B-I-D — Class 4 Agenls 
Appendix B-i-D-1 — Bacterial Agents 
Appendix 3-I-D-2 — Fungal Age.nt3 
Appendix B-I-D-3 — Parasitic Agents 
Appendix E-I-D-4 — Viral. Rickettsial, and 
Chlamydia! Agents 
Appendix B— n — - Classification of 
Onccgenic Viruses on the Basis of 
Potential I Isz3rd 
Appendix B-il-A — Low-Risk Oncogenic 
Viruses 
Appendix B— II— B — Moderate-Risk 
Oncogenic Viruses 
Appendix B— III. — Class 5 Agents 
Appendix B— III— A — Animal Disease 
Organisms Which are Forbidden Entry 
into the United States by Law 
Appendix B— III— 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 Host-Vector Systems 
Appendix C-!V — Experiments Involving 
Bacillus subtilis Host-Vector Systems 
Appendix C-V — Extrachromosomal 
Elements of Gram Positive Organisms 
Appendix C-VI — 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-! — 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 ip 
Organisms Other than E. coli K-12 
Appendix F-IV — Specific Approvals 
Appendix C. Physical Containment 
Appendix C-I — Standard Practices and 
Training 
Appendix G — II — Physical Containment 
Levels 
Appendix G-II-A — Biosafety Level 1 (BLi j 
Appendix G-II-A-1 — Standard 
Microbiological Practices 
Appendix C-Il-A-2 — Special Practices 
Appendix G-II-A-3 — Containment 
Equipment 
Appendix C-II-A— 4 — Laboratory Facilities 
.Appendix C— I!— B — Biosafety Level 2 (BL2) 
Appendix G-II-B-1 — Standard 
Microbiological Practices 
Appendix G-II-B-2 — Special Practices 
Appendix G-II-3-3 — Containment 
Equipment 
Appendix G — II— B — 4 — Laboratory Facilities 
Appendix G-Il-C — Biosafety Level 3 (BL3) 
Appendix G-II-C-l — Standard 
Microbiological Practices 
Appendix G-II-C-2 — Special Practices 
Appendix G-II-C-3 — Containment 
Equipment 
Appendix C-II-C— 4 — Laboratory Faciliti es 
Appendix G-II-D — Biosafety Level 4 (EL-5) 
Appendix C-II-D-1— Standard 
Microbiological Practices 
Appendix G-II-D-2 — Special Practices 
A.ppendix C-II-D-3 — Containment 
Equipment 
Appendix G-II-D— 1 — Laboratory Facilities 
Appendix C— 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 — HV1 
Appendix I-I-A-l — EKl 
Appendix I-I-A.-2 — Other HVl 
Appendix I-I-B — HV2 
Appendix I— II — Certification of Host- 
Vector Systems 
Appendix I— II— A — Responsibility 
Appendix I— II— B — Data to be Submitted for 
Certification 
Appendix I— II— 3—1 — HVl Systems Other 
than E. ccii K-12 
Appendix I— II— 3— 2 — HV2 Systems 
Appendix I— III — Footnotes and References 
of Appendix I 
Appendix J. Biotechnology Science 
Coordinating Committee 
Appendix K. Physical Containment for Large- 
Scale Uses of Organisms Containing 
Recombinant DNA Molecules 
Appendix K-I — Selection of Physical 
Containment Levels 
Appendix K-II — BL1-LS Level 
Appendix K— III — BL2-LS Level 
Appendix K-IV — BL3-LS Level 
Appendix L. Release into the Environment of 
Certain Plants 
Appendix L-I — General Information 
Appendix L-II — Criteria Allowing Review 
by the RAC Plant Working Group 
Recombinant DNA Research, Volume 1 1 
