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Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
eliminated the requirement that each 
institution have an IBC, would have 
eliminated requirements for prior 
approval for certain experiments, would 
have eliminated the prohibitions 
(although two would be retained instead 
as admonishments), and would have 
lowered the containment levels of most 
experiments mandated at P2 or P3 to PI 
recommendation. 
Thirty-five commentators supported 
the principles of the September 1981 
RAC proposal. The Chairman of one IBC 
which unanimously endorsed the 
September 1981 RAC proposal wrote: 
In the CoHimittee's view, recombinant DNA 
per se presents no hazard that is qualitatively 
different from the hazards associated with 
the pathogenicity of the hosts or vectors used. 
Hosts or vectors containing recombinant 
DNA should, therefore, be handled according 
to appropriate guidelines already in 
existence, such as the CDC guidelines for 
work with infectious organisms. 
Another IBC Chairman, reporting the 
unanimous IBC endorsement of the 
September 1981 RAC proposal, wrote: 
It is our Committee’s belief that relaxation 
of the federal guidelines is based on careful 
study by RAC and ORDA and that public 
safety is not jeopardized. 
Another IBC Chairman stated: 
The adoption of these revisions proposed 
by the RAC will, in effect, place recombinant 
DNA research in the same voluntary 
compliance status as that research which 
employs any etiologic agent. 
A County Health Department also 
endorsed the September 1981 RAC 
proposal. A University Vice President in 
reporting endorsement by the University 
of the RAC proposal, stated: 
While we are in complete agreement that 
control of biological systems involving 
recombinant DNA should be at a level 
consistent with the appraised risk, we do not 
believe that the de facto regulation of 
recombinant DNA research, as represented 
by the current 'Guidelines' or by the 
Gottesman F*roposal (FR December 7, 1981, is 
necessary to achieve adequate control). 
A letter stated: 
Based on my experience in medical 
microbiology and my service on the RAC. I 
believe that the RAC proposal described in 
the Federal Register is appropriate and 
sensible. 
A foreign commentator wrote: 
There seems to me to be no valid reason 
for mandatory regulations via guidelines of 
recombinant DNA research since there is no 
evidence that this activity is intrinsically 
hazardous. 
Another commentator wrote: 
The principle of prior review should be 
abandoned. It is needlessly expensive and 
time-consuming. 
A Noble Prize winner wrote: 
It makes no sense to have more stringent 
requirements for research that carries only 
vague hypothetical risks than for experiments 
involving known pathogenic microbes. 
Volimtary guidelines have worked quite well 
for research involving pathogens and should 
work equally well for microbes containing 
recombinant DNA * • • there is no 
scientiHc or social justiHcation for retaining 
rules for recombinant DND research that 
inhibit creativity and waste resources. 
Another Nobel Prize winner wrote: 
There is widespread agreement that the 
risks that were once through! to be so 
plausible are actually remote or possible 
nonexistent. If that judgement is correct, and 
I know of no evidence to indicate otherwise, 
then it seems wasteful of effort and money, 
even counter-productive, to maintain the 
elaborate procedures and organizations that 
were set up to be guard against the 
hypothetical risks. 
I note that the RAC carefully 
considered the points made in these 
letters; however, the RAC members 
were more convinced by the arguments 
made in support of the Gottesman 
proposal. I concur with this analysis. 
Positions Intermediate Between the 
September 1981 RAC Proposal and the 
Gottesman Praposal 
Ten letters were received supporting a 
position intermediate between the 
September 1981 RAC proposal and the 
Gottesman proposal. 
One IBC Chairman, on behalf of his 
biosafety committee, wrote: 
We believe the RAC proposal (Federal 
Register December 4, 1981) goes too far in 
removing certain restrictions, and that the 
Gottesman proposal (Federal Register 
December 7, 1981) is more restrictive than 
necessary. 
The Executive Director of Industrial 
Biotechnology Association (IBA), 
writing on behalf of the Board of 
Directors of the IBA, commented: 
We believe that the December 4 proposal 
by the RAC and the December 7 proposal by 
Dr. Susan Gottesman are each persuasive in 
some respects. Their best features should be 
combined to replace the present guidelines 
with a modernized version that will 
encourage variety and innovation to a greater 
extent, while retaining the confidence of both 
the scientific community and the general 
public. 
The IBA proposal would combine the 
more stringent mandatory "Roles and 
Responsibilities" of the Gottesman 
proposal with the more lenient 
containment levels of the September 
1981 RAC proposal. The opposite 
approach, combining the Gottesman 
proposal containment levels with the 
voluntary nature of the September RAC 
proposal, was advanced by another 
commentator as follows: 
I have studied the two published Federal 
Register proposals for revising the NIH 
Guidelines for Research Involving 
Recombinant DNA and have concluded that 
neither proposal adequately meets the 
current situation * * *. As a result of this 
analysis I would like to propose a middle 
ground between the two published proposals. 
This takes the form of an advisory set of 
Guidelines based on the Gottesman proposal. 
In other words, the Gottesman proposal 
remains substantively intact, but is put in the 
form of recommendations or real Guidelines, 
rather than regulations. 
A former member of the RAC wrote: 
First, I enthusiastically endorse the concept 
of reducing both the containment 
requirements and the administrative review. 
However, as to the means of achieving the 
reduction, I don't find either proposal to be 
fully satisfactory * * *. In summary, I would 
like to see the regulatory aspects of the 
guidelines kept in place for a bare handful of 
experimental systems. 
Another commentator wrote: 
We urge the Recombinant DNA Advisory 
Committee to preserve those mechanisms at 
both the institutional and national levels 
which ensure continuity in judgement in 
determining the appropriate containment 
requirements when new host-vector systems 
are developed, or for other novel applications 
of this technology. 
Another commentator stated: 
However, while endorsing the basic 
tenants of the Gottesman proposal to retain 
some oversight of federally-supported 
research on recombinant DNA, some 
compromise between the Gottesman and 
Baltimore/Campbell proposals to avoid some 
of the unnecessary restrictions of the former 
would seem appropriate. 
Another commentator favored RAC 
adoption of the Gottesman proposal 
now "with a provisional endorsement of 
its own proposal as an objective to be 
achieved” in the future. 
I note that the RAC carefully 
considered the points made in these 
letters, but they favored sppporting the 
December 7 proposal rather than a 
position intermediate between the 
December 7 and December 4 proposals. I 
concur with this analysis. 
Support for the Gottesman Proposal 
Thirty-two commentators favored the 
Gottesman proposal. One IBC Chairman 
reporting unanimous endorsement by 
the IBC stated: 
The Gottesman proposal would greatly 
simplify the current guidelines, eliminating 
considerable confusion, while creating a 
much more usable guide for experimental 
scientists to follow. 
Another IBC Chairman wrote: 
After some discussion, the IBC reached a 
consensus that the current practice does not 
impair research activities to a significant 
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