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Federal Register / Vol. 44. No. 73 / Friday, April 13, 1979 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Pub. L. 92-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the Linden Hill Hotel. Terrace Room. 
5400 Pooks Hill Road, Bethesda, 
Maryland 20014, on May 21, 22, and 23, 
1979, from 9:00 a.m. to 5.00 p.m. 
The entire meeting will be open to the 
public for consideration of: Lower 
Eukaryote Host-Vector Systems, 
Prokaryote Host-Vectors Other Than E. 
coli K-12, Amendment of Guidelines, 
Actions under exemption I-E-5, 
Exemptions for organisms that exchange 
genetic information (I-E-4), E. coli 
phage-vector systems. EK2 host-vector 
systems, N1H risk-assessment plan. 
Reports of Plasmid and Phage 
Subcommittees, Review of protocols for 
required containment levels, Criteria for 
and the handling of characterized 
clones. Requests for lowering of 
containment levels on the basis of 
characterization of clones, Other 
matters requiring necessary action by 
the Committee. 
Attendance by the public will be 
limited to space available Dr. William J. 
Gartland, Jr., Executive Secretary. 
Recombinant DNA Advisory Committee 
National Institutes of Health, Building 
31, Room 4A52, telephone 301^196-6051, 
will provide materials to be discussed at 
the meeting, rosters of committee 
members and substantive program 
information. A summary of the meeting 
will be available at a later date. 
Dated: March 30. 1979. 
Suzanne L F rsmeau. 
Committee Management Officer. NIH 
(FR Doc 79-11380 Filed 4-11-7* 8 45 am) 
BILLING COOE 4 1 10-08-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS. DHEW. 
ACTION: Notice of proposed actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
Summary: This notice sets forth 
proposals for actions to be taken under 
the 1970 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(Federal Register on December 22, 1978 
(43 FR 60108)]. 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 it? May 21-23, 1979, 
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 
May 14, 1979. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 4A52, 
Nation 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 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Drs. Michael Resnick or Stanley 
Barban, 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 (43 PR 60108), as well as 
actions under these Guidelines. 
1. Cloning of Eukaryotic Viruses in 
Saccharomyces cerevisiae and 
Neurospora crassa 
The RAC at its February 157 I 6 
meeting recommended the use of 
Saccharomyces cerevisiae and 
Neurospora crassa as HVl systems and 
specified certain strains and vectors of 
S. cerevisiae as HV2 host-vector 
systems. The RAC also recommended 
the following containment levels for 
experiments involving complete 
genomes of eukaryotic viruses: 
Experiments involving complete genomes 
of eukaryotic viruses will require P3 + HV1 or 
P2 + HV2 containment. 
General equivalency between both 
the N, crassa and the S. cerevisiae HV 
systems and the E. coli EK systems was 
recommended by the RAC. However, 
there was concern over the possible 
expression of eukaryotic viral genomes 
in the lower eukaryote hos4-vector 
systems. Therefore, the RAC has 
recommended that the cloning of these 
viruses be subject to higher levels of 
containment than those required for 
cloning in E. coli. 
2. Use of Unmodified Laboratory Strains 
of Neurospora crassa 
The RAC at its February 15-16, 1979 
meeting recommended a limited use of 
unmodified laboratory strains of 
Neurospora crassa. The NIH accepted a 
conservative interpretation of the RAC's 
action, limiting its use as a host, at the 
P3 level of containment, for shotgun 
experiments with phages, plasmids, and 
DNA from Class 1 prokaryotes [1] and 
lower eukaryotes that do not produce 
polypeptide toxins. [34] The following 
alternate interpretation of the RAC’s 
action is published for comment and 
further consideration by the RAC: 
Unmodified laboratory strains of 
Neurospora crassa can be used in all 
experiments for which HVl N. crassa 
systems are approved provided that these are 
carried out at physical containment one level 
higher than required for HVl. However, if P3 
containment is specified for HVl N. crassa, 
this level is considered adequate for 
unmodified N. crassa. For P2 physical 
containment, special care must be exercised 
to prevent aerial dispersal of macroconidia, 
including the use of a biological safety 
cabinet. 
3. Modification of Section III-C-6 — 
Transfer of Cloned DNA Between 
Eukaryotes 
The RAC at its February 15-16, 1979 
meeting recommended that a new 
section, III-C-6, be incorporated into the 
Guidelines, as follows: 
III-C-6. Return of DNA Segments to a 
Higher Eukaryotic Host of Origin. DNA from 
a higher eukaryote (Host D) may be inserted 
into a lambdoid phage vector or into a vector 
from a certified EK2 host-vector system and 
propagated in E. coli K-12 under the 
appropriate containment conditions [See 
Section III-A-1). Subsequently, this 
recombinant DNA may be returned to Host D 
and propagated under conditions of physical 
containment comparable to Pi and 
appropriate to the organism under study. [2A] 
Several commentators had requested 
that this section be broadened to perpiit 
the transfer of DNA segments to a 
heterologous eukaryote instead of only 
to the host of origin. The RAC, at its 
February 15-16, 1979 meeting felt that 
the proposal of the commentators would 
require further consideration and more 
explicit formulation. Accordingly, the 
following section has been proposed to 
replace the previously recommended 
Section III-C-6: 
III-C-6. Transfer of cloned DNA segments 
to eukaryotic organisms. DNA from any 
nonprohibited source [Section I-D] which has 
been cloned and propagated in E. coli under 
appropriate physical containment conditions, 
may be transferred with the E. coli vector 
used for cloning to a eukaryotic organism or 
cells in culture and propagated under 
conditions of physical containment 
comparable to PI and appropriate to the 
organism under study. [2A] 
[ 93 ] 
