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Federal Register / Vol. 46, No. 54 / Friday. March 20, 1981 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS, DHHS. 
action: Notice of actions under NIH 
guidelines for research involving 
recombinant DNA molecules. 
SUMMARY: This notice sets forth 
proposed actions to be taken under the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
After consideration of these proposals 
and comments by the NIH Recombinant 
DNA Advisory Committee (RAC) at its 
April 23-24, 1981 meeting, the Director 
of the National Institutes of Health will 
issue decisions on these proposals in 
accord with the Guidelines. 
date: Comments must be received by 
April 20, 1981. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office 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 8:30 
a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
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- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following changes and 
amendments under the Guidelines for 
Research Involving Recombinant DNA 
Molecules, as well as actions under 
these Guidelines. 
I. Proposed Revision of Guidelines for 
Recombinant DNA Experiments 
Involvwg E. Coli K-12 and 
Saccharomyces Cerevisiae Host-Vector 
Systems 
Containment requirements and 
administrative procedures for the 
conduct of most recombinant DNA 
experiments involving EKl E. coli K-12 
and laboratory strain Saccharomyces 
cerevisiae host-vector systems are 
currently specified by Section III-O of 
the Guidelines. The chairpersons of 
Institutional Biosafety Committees, at a 
meeting in Washington, D.C. on 
2- A20033 0 1 1 2(06K 19-MAR-8I-15: 34:49) 
November 24-25, 1980, passed by a large 
majority a resolution that experiments 
currently covered by Section Ill-O 
should be made exempt from the 
Guidelines. The chairpersons felt that 
the risks associated with these 
experiments are negligible, and that 
exemption of experiments currently 
covered by Section III-O would reduce 
paperwork by approximately 90%. 
This proposal was discussed by the 
RAC at its meeting on January 8-9, 1981. 
In "straw votes" at the meeting, an 
overwhelming majority of RAC 
members favored doing something to 
reduce materially or eliminate the 
paperwork and reporting functions for 
experiments covered by Section III-O; 
about half the RAC members felt serious 
consideration should be given to 
exempting entirely from the Guidelines 
experiments currently covered by 
Section III-O. The RAC requested that a 
series of options be developed and 
published for comment in the Federal 
Register. Accordingly, the following 
options will be considered at the April 
23-24, 1981 meeting of the RAC. 
Note. — It is recognized that changes will be 
necessary in a number of sections of the 
Guidelines in order to implement whatever 
option is selected. Necessary editorial 
changes will be made by the NIH Director 
when a final decision on the 
recommendations of the RAC is promulgated. 
Option A — Review by an Institutional 
Official of Experiments Covered by 
Section III-O: Under Option A, 
experiments currently covered under 
Section Ill-O would remain under 
Section Ill-O. However, rather than 
requiring IBC review of all registration 
documents, option A would specify that 
experiments covered by Section III-O 
could be reviewed by a designated 
institutional official. This official may be 
a member of the IBC. Large-scale 
experiments (e.g., more than 10 liters of 
culture) would continue to be reviewed 
by procedures specified by RAC. 
Two types of experiments, currently 
covered under Section III-O, are treated 
differently from the majority of 
experiments under this Section. These 
experiments are: 
(1) Experiments involving the cloning 
in E. coli K-12 of DNA from CDC Class 
3 etiological agents. These experiments 
currently require P3 containment 
conditions. 
(2) Experiments involving a deliberate 
attempt to have E. coli K-12 efficiently 
express a eukaryotic gene. This type of 
experiment currently requires prior 
review and approval by the IBC. 
These cases may be handled under 
one of the following suboptions: 
Suboption A-l-a: Under Suboption A- 
1-a, experiments involving DNA from 
[74] 
CDC Class 3 etiological agents would 
continue to require P3 containment and 
continue to require review by the IBC. 
Suboption A-l-b: Under Suboption A- 
1-b, experiments involving Class 3 
agents would continue to require P3 
containment, but review may be 
effected by a designated institutional 
official. 
Suboption A-l-c: Under Suboption A- 
1- c, experiments involving Class 3 
agents would require Pi containment 
and would be reviewed by a designated 
institutional official. This option would 
relax the requirements for these 
experiments to the same level as 
experiments with CDC Class 1 or Class 
2 agents. 
Suboption A-2-a: Under Suboption A- 
2- a, deliberate attempts to obtain 
expression of a eukaryotic gene in E. 
coli K-12 would continue to require 
prior review and approval by the IBC. 
Suboption A-2-b: Under Suboption A- 
2-b, deliberate attempts to obtain 
expression of a eukaryotic gene in E. 
coli K-12 would require prior review by 
a designated institutional official. 
Suboption A-2-c: Under Suboption A- 
2-c, no prior review would be required 
of attempts to obtain expression of a 
eukaryotic gene in E. coli K-12 
Option B — Elimination of Registration 
Requirements for Experiments Covered 
by Section III-O: Under Option B, 
experiments currently covered under 
Section III-O would remain under 
Section III-O. However, under Option B, 
the current requirements for the 
registration and review of experiments 
covered by Section III-O would be 
eliminated. That is, under Option B, no 
registration or review of such 
experiments, by the IBC or by an 
institutional official, would be required. 
Large-scale experiments (e.g., more than 
10 liters of culture) would continue to be 
reviewed by procedures specified by the 
RAC. 
The following suboptions might be 
considered for handling the special 
cases of (1) cloning of DNA from CDC 
Class 3 agents in E. coli K-12, and, (2) 
deliberate attempts to efficiently 
express eukaryotic genes in E. coli K-12. 
Suboption B-l-a: Under Suboption B- 
1-a, experiments involving the cloning 
of DNA from CDC Class 3 etiological 
agents in E. coli K-12 would continue to 
require P3 containment conditions and 
continue to require review by the IBC. 
Suboption B-l-b: Under Suboption B- 
1-b, experiments involving the DNA of 
Class 3 agents would continue to require 
P3 containment conditions. However, no 
registration document would be 
required, nor would review by the IBC 
