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Federal Register / Vol. 47, No. 60 / Monday. March 29, 1982 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
AGENCY: National Institutes of Health. 
PHS. HHS. 
action: Notice of actions under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth actions 
taken by the Acting Director, NIAID, by 
authority of the Director, NIH, under the 
1981 Guidelines for Research Involving 
Recombinant DNA Molecules (46 FR 
34462). 
EFFECTIVE DATE: March 29, 1982. 
FOR FURTHER INFORMATION CONTACT.* 
Additional information can be obtained 
from Dr. William |. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda, 
Maryland 20205 (301) 496-6051. 
SUPPLEMENTARY INFORMATION: I am 
promulgating today several major 
actions under the NIH Guidelines for 
Research Involving Recombinant DNA 
Moelcules. These proposed actions were 
published for comment in the Federal 
Register of December 7, 1981 (46 FR 
59734), and January 6, 1982 (47 FR 732). 
and reviewed and recommended for 
approval by the Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on February 8-9, 1982. In 
accordance with Section IV-E-l-b of 
the NIH Guidelines, I find that these 
actions comply with the Guidelines and 
present no significant risk to health or 
the environment. 
Part I of this announcenient provides 
background information on the actions. 
Part II provides a summary of the major 
actions. 
The decision on the “Gottesman 
proposal” which was also recommended 
by the RAC at their February 8-9. 1982, 
meeting, will be issued at a later date. 
I. Decisions on Actions Under 
Guidelines 
A. Request for Permission to Clone 
Subgenomic Segments of the Foot and 
Mouth Disease Virus. The RAC 
considered a proposal submitted by 
Molecular Genetics, Inc. (MGI), of 
Minnetonka, Minnesota, to transfer E. 
coli K-12 clones comprising less than 
75% of the Foot and Mouth Disease 
Virus (FMDV) genome from the Plum 
Island Animal Disease Center (PIADC) 
to the MGI research facility in 
Minnesota and to conduct experiments 
with these clones under Pi containment 
conditions. A notice of this proposal 
was published for 30 days comment in 
the Federal Register of January 6, 1982 
(47 FR 732). No comments were received 
during this period. It was noted that the 
proposal is almost identical to one 
previously approved by NIH. (See 
Federal Register of January 17, 1980, pg. 
1059; July 29. 1980, pg. 50528; and March 
12, 1981, pg. 16455). After discussion, the 
RAC, by a vote of 16 in favor, none 
opposed and 4 abstentions, 
recommended approval of the proposal 
contingent upon review by a working 
group of the RAC of data on infectivity 
testing of the clones, prior to their 
transfer from PIADC. 
I accept this recommendation and text 
has been added to Appendix E of the 
Guidelines indicating this action. 
B. Request to use Bacillus Megaterium 
in Recombinant DNA Experiments 
under Pi Containment. A request 
submitted by Dr. Patricia Vary of 
Northern Illinois University, DeKalb, 
Illinois, to transfer recombinant DNA 
segments derived from E. coli, Bacillus 
subtilis. and Staphylococcus aureus into 
Bacillus megaterium under PI 
containment conditions was considered 
by the RAC at its February 8-9, 1982 
meeting. A notice concerning this 
request appeared in the Federal Register 
of December 7, 1981 (46 FR 59734). No 
comments were received on the 
proposal. 
The RAC, after discussing this 
proposal, recommended approval under 
P2 containment conditions with the 
stipulation that the local IBC be 
authorized to lower containment to Pi 
for specific experiments. The vote for 
approval of this recommendation was 13 
in favor, none opposed, and 1 
abstention. 
I accept this recommendation and text 
has been added to Appendix E of the 
Guidelines indicating this action. 
C. Proposed Pseudomonas Putida 
Host-Vector System. In response to a 
request from Professor Michael 
Bagdasarian of the Max-Plank-Institut 
Fur Molekulare Genetik, Berlin, West 
Germany, a notice was published in the 
Federal Register of December 7, 1981 (46 
FR 59734). The investigator requested 
HVl certification of a new host-vectpr 
system based on Pseudomonas putida 
strain KT2440 and plasmid cloning 
vectors pKT262, pKT263, and pKT264. 
During the public comment period no 
responses were received. 
The RAC discussed this proposal at 
its February 8-9, 1982 meeting. It was 
noted that the cloning system would 
have broad utility. The data indicate 
that the plasmid vectors have been 
constructed to be poorly mobilizable. 
The data submitted meet the criteria for 
HVl. The RAC by a vote of 18 in favor. 
none opposed, and 1 abstention 
reconunended that this system be 
approved as a new HVl system. 
I accept this recommendation, and 
appropriate text has been added to 
Appendix F of the Guidelines. 
D. Request to Clone Plant DNA in the 
Cyanobacterium Anacystis Nidulans. In 
a letter dated September 24, 1981, Dr. 
Lawrence Bogorad of Harvard 
University requested permission to 
initiate, at PI containment, a program 
involving the cloning of DNA from 
chloroplasts of various plants (initially 
primarily from Zea mays] in the 
cyanobacterium Anacystis nidulans 
strain R2. Dr. Bogorad would employ the 
plasmid vector pUCl04, a construct of 
the cyanobacterial plasmid pUCl and 
the E. coli vector pACYCl84. A notice of 
this proposal appeared in the Federal 
Register of January 6, 1982 (47 FR 732) 
for public comment. No comments were 
received on the proposal. 
The RAC discussed the proposal at 
the February 8-9, 1982 meeting. It was 
noted that neither Anacystis nidulans 
nor plant chloroplasts produce toxins. In 
addition, A. nidulans does not exchange 
genetic information with other 
cyanobacteria. By a vote of fourteen in 
favor, none opposed, and no 
abstentions, RAC recommended that the 
project be approved at the PI level of 
containment. 
I accept this recommendation and a 
new entry has been added to Appendix 
E of the Guidelines. 
E. Proposed Inclusion of Yersinia 
Enterocolitica on Sublist A, Appendix A, 
In a letter dated September 22, 1981, Dr. 
Guy Cornelis of the Universite 
Catholique de Louvain, Brussels, 
Belgium requested that Yersinia 
enterocolitica be exempted from the 
Guidelines under the provisions of 
Section I-E-4 by being added to Sublist 
A, Appendix A, of the Guidelines. In 
support of this request. Dr. Cornelis 
supplied data indicating that Y. 
enterocolitica exchanges genetic 
information with E. coli. 
Dr. Cornells’ request was published 
for comment in the December 7, 1981, 
Federal Register (46 FR 59734). No 
comments concerning the request were 
received. 
The RAC discussed the request at the 
February 8-9, 1982 meeting. During the 
discussion, it was noted that some 
strains of Y. enterocolitica cause human 
disease; however, the organism is 
ubiquitous. The frequency of transfer of 
DNA between E. coli and Y. 
enterocolitica is three orders of 
magnitude lower than E. coli — E. coli 
exchange. However, exchange does 
occur and on this basis Y. enterocolitica 
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