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Federal Register / Vol. 46, No. 234 / Monday. December 7, 1961 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS. DHHS. 
action: Notice to Proposed 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 
next meeting, the Director of the 
National Institute of Allergy and 
Infectious Diseases will issue decisions 
on these proposals in accord with the 
Guidelines. 
DATE: Comments must be received by 
February 1, 1982. 
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. 
1. Proposed Revision of Guidelines 
Dr. Waclaw Szybalski, McArdle 
Laboratory for Cancer Research, 
University of Wisconsin, Madison, 
Wisconsin, has requested that the 
following sentence be added to the 
current NIH Guidelines: 
“These are only Guidelines based on 
the current state of the research and on 
the concerns of certain individuals or 
groups about the hypothetical risks. 
Individual researchers should use their 
best scientific judgement and peers' 
advice when designing, modifying and 
conducting experiments, and be 
prepared to justify any substantial 
variations when requested, or in their 
applications and progress reports." 
2. Request To Use Bacillus Megaterium 
in Recombinant DNA Experiments 
Under PI Contaiiunent 
Dr. Patricia Vary of Northern Illinois 
University, DeKaib, Illinois, requests 
permission to introduce recombinant 
DNA derived from Staphylococcus 
aureus, E. coli, and Bacillus subtilis into 
Bacillus megaterium under Pi 
conditions. 
3. Proposed EK2 Host- Vector Systems 
Dr. Roy Curtiss, University of 
Alabama, Birmingham, Alabama, 
requests EK2 certification of six 
different E. coli K-12 strains in 
conjunction with various virulent and 
temperate bacteriophage lambda, 
plasmid and cosmid vectors. Dr. Curtiss 
also requests that all previously 
approved vectors be approved as vector 
components of the proposed EK2 host- 
vector systems. Detailed information on 
the proposed host-vector systems has 
been provided by Dr. Curtiss. 
4. Proposed use of EK2 Host- Vector 
Systems for Cloning DNA from Class 3 
and 4 Etiologic Agents 
Dr. Roy Curtiss, University of 
Alabama, Birmingham, Alabama, 
requests permission to use all certified 
EK2 host-vector systems to clone DNA 
fragments from Class 3 and Class 4 
etiologic agents under P2 containment, 
and under Pi containment if the 
recombinant clones are shown not to 
express a virulence determinant that has 
toxic potential. 
As an alternative to this general 
proposal. Dr. Curtiss requests 
permission to clone DNA from Yersinia 
pestis and Mycobacterium leprae into 
EK2 host-vector systems under P2 
containment, and under PI conditions -in 
the absence of expression of virulence 
determinants by the recombinant clones. 
5. Proposed Pseudomonas Putida Host- 
Vector System 
Dr. Michael Bagdasariun of the Max- 
Planck Institute of Fur Molekulare 
Genetik. Berlia West Germany, requests 
HVl certification of a host-vector 
system based on Pseudomonas putida 
strain KT2440 and cloning vectors 
PKT262. pKT263, and pKT264. 
6. Proposed Inclusion of Yersinia 
Enterocolitica on Sublist A, Appendix A 
Dr, Guy Cornells of the Universite 
Catholique de I„ouvain, Brussels, 
Belgium, requests that Yersinia 
enterocolitica be exempted from the 
Guidelines under Section I-E-4 and 
added to Sublist A, Appendix A, on the 
basis that this species exchanges genetic 
information with E. coli. 
7. Proposal for Revision of the 
Guidelines 
Dr. Susan Gottesman of the National 
Cancer Institute of the National 
Institutes of Health has requested that 
the following proposal to modify the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules be 
published in the Federal Register for 
comment: 
/. Introduction 
There seems to be a clear consensus 
that the guidelines require 
simplification, reorganization, and 
possible lowering of containment levels 
for some classes of experiments. The 
Recombinant DNA Advisory Committee 
(RAC) will be considering at its next 
meeting a proposal, published for 
comment in the Federal Register, to 
convert the NIH Recombinant DNA 
Guidelines into a voluntary code of 
practice. This proposal would change 
the detailed listing of containment levels 
to a few paragraphs of advice to the 
investigator. I am recommending an 
alternative approach to revision which 
retains some aspects of the cuirent 
guidelines which I consider necessary 
for the continued orderly development 
of the recombinant DNA field. 
(1) My proposal, as opposed to the 
RAC proposal, retains the requirement 
for IBC oversight of some experiments, 
and retains the current NIH compliance 
requirements. In addition, the record- 
keeping function of the IBC is retained. 
Since many experiments became exempt] 
from the requirements of the Guidelines 
as of July 1, 1981, the remaining 
requirements should not be too 
cumbersome to either the experimenter 
or the IBC. 
(2) My proposal simplifies the 
structure of the Guidelines and 
decreases containment for some classes j 
of experiments. In particular, 
experiments involving non-pathogenic 
prokaryotes and lower eukaryotes couldj 
be carried out at Pi containment. 
Overall, containment levels would not, 
however, be lowered to the extent 
recommended in the RAC proposal. 
II. Summary of Proposed Changes as 
Compared to Current Guidelines 
A. Prohibitions. The word 
“prohibition” will no longer be applied 
to this class of experiments which 
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