Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77375 
if an HV2 B. subtilis host-vector system 
were available. Since an HV2 B. subtilis 
system is in fact now certified (see item 
III of this announcement) I am approving 
the cloning of the Staphylococcus 
aureus Tox A gene in an HV2 Bacillus 
subtilis host-vector system at P3 
containment. Text has been added to 
Appendix E indicating this. 
VIII. Request for Permission to 
Transform Chlamydomonas Reinhardi 
With E. Coli/Saccraromyces Cerevisiae 
Plasmids. 
The RAC at its September 25-26, 1980 
meeting considered similar requests 
from Dr. John Carbon of the University 
of California, Santa Barbara, and Dr. 
Stephen Howell of the University of 
California, San Diego, to introduce E. 
coli-Saccharomyces cerevisiae hybrid 
plasmids containing defined DNA 
segments into Chlamydomonas 
reinhardi under P2 conditions. The host 
is a eukaryotic, unicellular 
photosynthetic green algae. C. reinhardi 
is non-pathogenic, produces no known 
toxin, and is not known to exchange 
genetic information with other 
organisms. 
This proposal was published for 
comment in the Federal Register of 
August 21, 1980. No comments were 
received during the thirty day period for 
comment. 
A motion to approve these 
experiments at the P2 level of 
containment was passed by a vote of 16 
in favor, none opposed, and one 
absention. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
IX. Request For Permission To 
Transform Candida Albicans With E. 
Coli-S. Cerevisiae Plasmid. 
The following notice appeared in the 
Federal Register of August 21, 1980: 
Request for permission to transform 
Candida albicans with E. coli-S. cerevisiae 
plasimids. Dr. P. T. Magee of Michigan State 
University, and Dr. W. Lajean Chaffin of 
Texas Tech University, have requested 
consideration of the appropriate containment 
level for the return of Candida albicans DNA 
to the host of origin. The Candida albicans 
DNA will be cloned in E. coli K-12 or in 
Saccharomyces cerevisiae employing a 
hybrid plasmid vector derived from E. coli K- 
12-S. cerevisiae or the yeast 2 micron 
plasmid. 
During the thirty day comment period, 
no responses were received. 
The RAC discussed this proposal at 
its September 25-26, 1980 meeting. It 
was noted that Candida albicans is a 
normal inhabitant of the flora of man. It 
can be a pathogen in compromised 
individuals but does not produce a 
toxin. This is basically a return of DNA 
to host of origin type of experiment, with 
the intermediate host being either E. coli 
K-12 or Saccharomyces cerevisiae. 
The RAC by a vote of 14 in favor, 1 
opposed, and 3 absentions recommeded 
approval of this proposal at the P2 level 
of containment. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
X. Proposal To Transform Haemophilus 
Influenzae With E. Coli/H. Influenzae 
Hybrid Plasmid 
The RAC at its September 25-26, 1980 
meeting considered a proposal from Dr. 
Hamilton Smith of the John Hopkins 
University to insert an E. coli TnlO tet R 
gene into a naturally-occurring 
Haemophilus plasmid and to use the 
hybrid plasmid to transform H. 
influenzae Rd, a nonpathogenic strain. It 
was noted that a tetracycline resistance 
gene found naturally in Haemophilus is 
genetically related to the TnlO tet R gene 
of E. coli. A motion to approve these 
experiments at the Pi level of 
containment was passed by a vote of 12 
in favor, none opposed, with 7 
abstentions. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
XI. Proposed Exemption For 
Streptococcus Sanguis And 
Streptococcus Pneumoniae 
A request submitted by Dr. Walter 
Guild of Duke University Medical 
Center that Streptococcus sanguis and 
Streptococcus pneumoniae be 
considered as natural exchangers of 
DNA under the exemption category of 
Section I-E-4 and Appendix A of the 
Guidelines was considered by the RAC. 
This proposal was published for 
comment in the Federal Register of 
August 21, 1980. No comments were 
received during the 30 day period for 
comment prior to the September 25-26, 
1980 meeting. 
The evidence presented by the 
investigator demonstrated that these 
organisms exhange genetic material in 
both directions by the natural process of 
transformation. The RAC recommended 
by a vote of 16 in favor, none opposed, 
and 1 absention that a new sublist be 
added to Appendix A of the Guidelines 
exempting recombinant DNA 
experiments between Streptococcus 
sanguis and Streptococcus pneumoniae. 
I accept this recommendation and 
these two organisms have been added 
as sublist F of Appendix A. 
XII. Request For Permission To 
Incorporate Recombinant DNA In 
Zymomonas Mobilis 
The RAC considered a request from 
Drs. B. Montenecourt and D. Eveleigh of 
Rutgers University to permit the cloning 
of DNA derived from Pseudomonas 
strains that are non-pathogenic to 
animals or plants in an E. coli K-12 host, 
followed by transfer of the recombinant 
DNA into Zymomonas mobilis. 
This proposal was published for 
comment in the Federal Register of 
August 21, 1980. No comments were 
received during the 30 day comment 
period. 
The RAC by a vote of 17 in favor, 
none opposed and with no abstentions 
recommended approval at the P2 level 
of containment for the proposed 
experiments. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
XIII. Request To Transform Protoplasts 
of Streptosporangium With 
Recombinant DNA 
The RAC at its September 26, 1980 
meeting considered a proposal to 
transform protoplasts of 
Streptosporangium with a hybrid 
plasmid containing pBR322 plus a 
Streptosporangium plasmid into which 
have been incorporated specified DNA 
segments from Streptomyces species or 
an HVl approved Bacillus subtilis 
cloning vector. 
It was noted that members of the 
Streptosporangium genera are soil 
bacteria and have never been implicated 
in any human, animal, or plant diseases. 
Further, these nutritionally fastidious 
organisms have not been reported to 
produce toxins harmful to humans. 
The motion to approve these 
experiments at the P2 level of 
containment was passed by a vote of 17 
in favor, none opposed, and 1 
abstention. 
I accept this recommendation, and 
text has been added to Appendix E of 
the Guidelines indicating this. 
XIV. Proposed Revision of Subsections 
of Section III-C-1-e 
A notice appeared in the Federal 
Register of January 31, 1980 concerning 
proposed revision of Section III-C-1-e, 
and its subsections. It was 
recommended that Section III-C-1-e, 
Ill-C-l-e-(l), III-C-l-e-(lHa), and III- 
C-l-e-(l)-(b). of the Guidelines be 
changed and that a new Section III— C— 1— 
e-(l)-(c) be added. Section III— C— 1— e — (2) 
would remain unchanged. The RAC, at 
its March 6-7, 1980 meeting, 
recommended adoption of Section IU-C- 
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