59368 
Federal Register / Vol. 46, No. 233 / Friday. December 4. 1981 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research: 
Proposed Revised Guidelines 
aoency: National Institutes of Health, 
PHS. DHHS. 
action: Notice of proposed revision of 
the NIH guidelines for research 
involving recombinant DNA molecules. 
SUMMARY: This notice sets forth a 
proposed revision of the 1961 NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules (46 FR 
34462). Interested parties are invited to 
submit comments concerning this 
proposal. This proposal and comments 
on it will be considered by the NIH 
Recombinant DNA Advisory Committee 
(RAC) at its next meeting. 
OATS: Comments must be received by 
February 2. 1962. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, OfTice of Recombinant 
DNA Activities. Building 31. Room 4A52. 
National Institutes of Health, Bethesda. 
Maryland 20205. All comments received 
in timely response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 6:30 
a.m. and S.-OO p.m. 
EOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Drs. Stanley Barban or Elizabeth 
Milewski, Office of Recombinant DNA 
Activities, National Institutes of Health. 
Bethesda. Maryland 20205, (301) 496- 
eoei. 
SURRI.EMENTARY INFORMATION: I am 
today issuing for public comment 
proposed revised NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. This action is taken In 
accordance with Section IV-E-l-b-(l) 
of the NIH Guidelines. This 
announcement introduces the proposed 
revision, then gives the proposed revised 
Guidelines in their entirety, and then 
includes a series of annexes containing 
relevant background documents. These 
annexes are: 
Annex A: Original proposal of Drs. 
David Baltimore and Allan Campbell. 
Annex B: Documents prepared by 
Working Group on Revision of the 
Guidelines. 
Annex C: Minority reports of working 
group members. 
Annex D: Draft Minutes of relevant 
portion of September 10-11, 1981, RAC 
Meeting. 
Annex E: Current NIH Guidelines. 
The history of development of these 
proposed revised Guidelines is as 
follows. Drs. David Baltimore and Allan 
Campbell. RAC members, had proposed 
a major revision of the Guidelines 
(Baltimore-Campbell proposed. Annex 
A), which was considered by the RAC at 
its April 1961 meeting. At the April 1981 
meeting, a Working Group on Revision 
of the Guidelines was established to 
review the Baltimore-Campbell proposal 
as well as other approaches which might 
lead to a major revision of the 
Guidelines. The Working Group met on 
June 1, 1981, and on July 9, 1981. The 
Working Group prepared a proposal for 
revising the Guidelines, a summary of its 
actions, and a document entitled 
"Evaluation of the Risks Associated 
with Recombinant DNA Research." 
These documents appear as Annex B. 
Two minority reports were prepared by 
several members of the Working Group 
(Annex C). The Working Group report 
and the minority reports were 
distributed to RAC members prior to the 
September 1961 meeting. 
The RAC extensively discussed the 
Working Croup's report and other 
approaches to revision of the Guidelines 
at its September 1981 meeting. Draft 
minutes of that discussion constitute 
Annex D. As indicated in those draft 
minutes, the RAC passed by a vote of 16 
in favor. 3 opposed, with 1 abstention, 
the elements of its version of a proposed 
revision of the Guidelines to be 
published for public comment. Based 
upon this proposal. NIH staff prepared 
the proposed revised Guidelines which 
are published immediately following this 
intr^uction, for public comment. For 
comparison, the current NIH Guidelines 
are given in Annex E. 
The proposed revised Guidelines and 
comments on them will be considered 
by the RAC at Its next meeting. 
The major features of the proposed 
revision are: 
1. The Guidelines would cease to be 
mandatory and would become a 
voluntary code of standard practice. 
Requirements that institutions have an 
Institutional Biosafety Committee (IBC), 
that investigators obtain prior approval 
from the IBC before beginning certain 
experiments, that investigators obtain 
prior approval from NIH before 
beginning certain experiments, and the 
section of the Guidelines specifying that 
noncompliance with the Guidelines 
could lead to loss of NIH funds, would 
all be eliminated. 
2. Section III of the Guidelines giving 
containment levels would be greatly 
simplified, and most experiments 
currently mandated at M or P3 
containment would be recommended at 
PI 
3. The prohibitions section (1-D) of the 
Guidelines would be eliminated, 
although two of the previous 
prohibitions would be retained instead 
as admonishments. 
Proposed Guidelines for Research 
Involving Recombinant DNA Molecules 
October 1981. 
Table of Contents 
I. Scope of the Guidelines 
I-A Purpose 
I-B DeHnition of Recombinant DNA 
Molecules 
l-C (Deleted) 
I-D (Deleted] 
l-E Exemptions 
I- F General DeHnitions (see IV-C) 
II. Containment 
II- A Standard Practices and Training 
U-B Physical Containment Levels 
ll-B-1 Pi Level 
11-B-l-a Laboratory Practices 
ll-B-l-b Containment Equipment 
ll-B-l-c Special Laboratory Design 
II-B-2 P2 Level 
II-B-2-a Laboratory Practices 
ll-B-2b Containment Equipment 
II-B-2-C Special Laboratory Design 
lI-B-3 P3 1.evel 
II-B-3-U Laboratory Practices 
ll-B-3-b Containment Equipment 
II-H-3-C Special Laboratory Design 
II-B-4 P4 l^vel 
ll-B-4-a Laboratory Practices 
II-B-4-b Containment Equipment 
II-B-4-C Special Laboratory Design 
Il-C Shipment 
Il-D Biological Containment 
Il-D-1 Levels of Biological Containment 
lI-D-l-a HVl 
n_D_l_b HV2 
lI-D-l-c HV3 
U-O-2 Certification of Host-Vector 
Systems 
Il-D-2-a Responsibility 
il-D-2-b Data To Be Submitted for 
Certification 
II-D-3 Distribution of Certified Host- 
Vectors 
III. Containment Guidelines for Covered 
Experiments 
rV. Roles and Responsibilities 
IV-A (Deleted) 
rV-B (Deleted! 
IV-C General Definitions 
IV-D Responsibilities of the Institution 
IV-E Responsibilities of NIH 
rV-E-1 Director 
IV-F.-2 Recombinant DNA Advisory 
Committee 
lV-E-3 The Office of Recombinant DNA 
Activities 
IV-E-4 Other NIH Components 
IV-F (Deleted) 
IV-G (Deleted) 
V. Footnotes and References 
VI. Voluntary Compliance 
Vl-A to Vl-E (Deleted) 
Vl-F Protection of Proprietary Data 
Appendix A — Exemptions Under I-E-4 
Appendix B — Classification of 
Microorganisms on the Basis of Hazard 
[ 257 ] 
