Federal Register / Vol. 46, No. 233 / Friday, December 4, 1981 / Notices 
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different from the risks associated with 
other kinds of genetic research, the end 
result may be an increase in virulence, 
host range, or survivability of some 
pathogens. 
Given these conclusions, the majority 
of those present at the July 9 meeting 
supported a proposal which adopts the 
containment provisions of the Baltimore- 
Campbell proposal, but retains the 
mandatory aspect of the guidelines. A 
minority preferred either a “voluntary 
code of practice” as stipulated in the 
original Baltimore-Campbell proposal, or 
an end to all specifications for working 
with recombinant DNA, apart from 
those stipulations of “good laboratory 
practice.” 
The text of the proposal as approved 
by the subcommittee, with a comparison 
to current (July 1, 1981) guidelines is 
attached. In addition, an examination of 
the state of our knowledge about 
recombinant DNA risks, to be used as a 
rationale for change, is attached. 
We suggest the following procedures: 
(1) RAC consider and modify if 
necessary, the working group’s proposal 
and the supporting rationale statement, 
(2) The modified proposal and rationale 
be published in the Federal Register and 
elsewhere, if appropriate, for public 
comment, (3) All comments be 
considered by the working group and 
recommendations for change, based on 
the comments, be made. The final 
version should once again be published 
in the Federal Register. (4) RAC take 
final action on the proposal. This might 
occur at the January 1982 RAC meeting, 
or possibly at the following meeting, if 
more time for comment is considered 
necessary. 
Recombinant DNA Advisory Committee 
Working Group on Revision of the 
Guidelines, National Institutes of Health 
Chairman 
Gottesman, Susan K., Ph. D., Senior 
Investigator, Laboratory of Molecular 
Biology, National Cancer Institute, National 
Institutes of Health, Bethesda, Maryland 
20205, (301) 496-2095 
Adelberg, Edward A., Ph. D., Department of 
Human Genetics, School of Medicine, Yale 
University, New Haven, Connecticut 06510, 
(203) 436-0821 
Berns, Kenneth 1., Ph. D., M.D., Chairman, 
Department of Immunology and Medical 
Microbiology, University of Florida, 
College of Medicine, Gainesville. Florida 
32610, (904) 392-3311 
Goldstein, Richard, Ph. D., Associate 
Professor, Department of Microbiology and 
Molecular Genetics, Harvard Medical 
School, Boston, Massachusetts 02115, (617) 
732-1911 
Harris, Jean L., M.D., Secretary of Human 
Resources, Commonwealth of Virginia, 
Office of Governor, Post Office Box 1475, 
Richmond, Virginia 23219, (804) 786-7765 
King, Patricia A., J.D., Georgetown University 
Law School, 600 New Jersey Avenue, N.W., 
Washington, D.C. 20001, (202) 624-8213 
Levine, Myron M., M.D., Director, Center for 
Vaccine Development, Division of 
Infectious Diseases, University of 
Maryland School of Medicine, Baltimore, 
Maryland 21201, (301) 528-7588 
Lewis, Herman W., Ph. D., Senior Scientist for 
Recombinant DNA, Division of Physiology, 
National Science Foundation, Washington, 
D.C. 20550, (202) 357-7647 
Mason, James O., M.D., Dr. Ph., Executive 
Director, Utah State Department of Health, 
Post Office Box 2500, Salt Lake City, Utah 
84113, (801) 533-6111 
Nightingale, Elena O., Ph. D., M.D., Senior 
Program Officer. Institute of Medicine, 
National Academy of Sciences, 
Washington, D.C. 20418, (202) 389-6963 
Tolin, Sue A., Ph. D., Science and Education 
Administration, Cooperative Research, U.S. 
Department of Agriculture, Washington, 
D.C. 20250, (202) 447-5741 
Williams, Luther S., Ph. D., Professor, 
Department of Biology, Washington 
University, Campus Box 1137, St. Louis? 
Missouri 63130, (314) 889-6843 
Zinder, Norton, Ph. D., Professor. Rockefeller 
University, 1230 York Avenue, New York. 
New York 10021, (212) 360-1322 
Executive Secretary 
Gartland, William |(. Jr., Ph. D., Director, 
Office of Recombinant DNA Activities, 
National Institute of Allergy and Infectious 
Diseases, National Institutes of Health, 
Bethesda. Maryland 20205, (301) 496-6051 
Revision of the July 1, 1981 Guidelines 
Proposed by Working Group on 
Revision of the Guidelines, July 9, 1981 
(1) Section I-A of the Guidelines 
would be amended to read as follows: 
I-A. Purpose. The purpose of these 
Guidelines to specify standard practices 
for constructing and handling (i) 
recombinant DNA molecules and (ii) 
organisms and viruses containing 
recombinant DNA molecules. 
(2) Section I-D of the Guidelines, 
Prohibitions, would be eliminated. 
(3) Part III of the GuitJelines would be 
replaced with the following language: 
Part III discusses experiments covered 
by the Guidelines. The reader should 
first consult Part I, where exempt 
experiments are listed. 
Where recommended physical 
containment levels applicable to non- 
recombinant DNA experiments exist for 
either the host or the vector (such as 
those specified by the GDC Guidelines, 
or the USDA Quarantine Regulations), 
recombinant DNA experiments should 
be carried out at containment levels at 
least as high as those recommended for 
non-recombinant DNA experiments. If 
there is clear evidence that the donor 
DNA will significantly change the 
pathogenicity of the host, the 
containment level appropriate to the 
anticipated change will be applied. 
Otherwise, all experiments may be 
carried out under conditions of Pi or Pl- 
LS physical containment. 
(4) Those membership specifications 
of the IBC to be found in Section IV-D of 
Section IV of the Guidelines would be 
eliminated. 
BILLING CODE 4110-08-M 
