Federal Register / Vol. 47. No. 77 / Wednesday. April 21. 1982 / Notices 
17175 
degr«« * * *. The Committee therefore 
recommends that the Guidelines be adjusted 
as necessary, but not abolished completely, 
nor made purely voluntary. 
The Chairman of the Cambridge. 
Massachusetts. Biohazards Committee 
stated; 
We recognize the need to simplify the 
Guidelines, particularly the specification of 
containment levels. We do not. however, 
think It wise or necessary to abolish 
Institutional Biosafety Committees * * *. Our 
own perception Is that the measured 
evolution of the Guidelines has been a model 
of the way new technologies can be 
introduced into densely populated areas with 
maximum safety and public reassurance. 
A University Vice Chancellor wrote: 
The Biosafety Committee feels strongly 
that whatever the federal action will be. 
every iiutitution should maintain a strong 
review board. For reasons of consistency 
throughout the scientific world and across 
state lines and to forestall posssible state 
legislative activities. It was agreed that 
mandatory controls would be preferable. In 
addition, the community members 
commented that “in an era whan science la 
suspect in the community, evidence of 
institutional review is most imporlanL'* 
An industrial commentator wrote; 
Plrst. we would like to support the 
continuing evolution of the recombinant DNA 
guidelines as our body of knowledge 
concerning this technology increases * * * 
Ws believe Or. Gottssman's proposal in 
general achieves these objectives, by setting 
reasonable standards for experiments for 
which sufficient information exists to do so 
and by assigning oversight responsibillUes for 
certain experiments to the IBC and the NTH 
based on a rational assessment of potential 
ha sard. 
One member of the RAC wrote; 
I believe it to be premature to do sway 
with all mandatory aspects of the 
guidelines * * * The alternative proposal by 
Susan Gottesman conatnictlvely deals with 
my cofKema while still doing away with 
much of the undesirable red tape and delays. 
Another RAC member wrote; 
I feel that to eliminate all mandatory 
aspects of the Guidelines and replace them 
with a voluntary code of practices is 
premature. 
Another RAC member wrote; 
I have come to the conclusion that, at least 
for now. we should retain the mandatory 
nature of the guidelines for recombinant DNA 
research, and the requirements for 
Institutional Biosafety Committees * * * My 
recommendation is to have a limited period 
of more relaxed regulations by supporting the 
Gottesman proposal now and immediately 
work to simplify the guidelines further as 
appropriate. 
Another commentator wrote: 
While decreased NIH supervision of large 
classes of nonhazardoua experiments is 
certainly desirable, the RAC proposal goes 
rather too far, in my view, in the direction of 
removing controls. It would seem desirable to 
maintain some NDi oversight of experiments 
involving a degree of risk, as in Dr. 
Cottesman's suggested revision. 
Another commentator wrote: 
Part of the lesson is to avoid extremes, and 
that is what Dr. Cottesman's proposal tries to 
accomplish. I urge the RAC to adopt a final 
recommendation that embodies the basic 
philosophy expressed in her proposal. 
A biological safety officer stated: 
* * * some sort of organized structure for 
the review of recombinant DNA research 
activities should still be required at 
institutions with researchers engaged in this 
type of work if they are to continue to receive 
NIH funding. 
Another commentator wrote: 
I favor strongly the retention of IBC 
oversight and current NDI compliance 
requirements as advocated by Dr. Gottesman. 
Another commentator wrote: 
* * * it is my opinion that the RAC 
proposal to dismantle the Guidelines and the 
review process would be a major mistake. 
Simplification of the Guidelines might well be 
useful, as proposed in the Alternative 
Proposal. 
Another commentator wrote; 
The Baltimore/Campbell proposal 
described in the Federal Raster would 
eliminate any meaningful controls of 
Recombinant DNA technology and would 
create a major hazard to the public health 
and safety 
A Nobel Prize winner wrote: 
|I| wish now to register strong objection to 
the Baltimore/Campbell proposal described 
in the Federal Register of December 4. 1961. 
proposing that the NIH Guidelines be 
changed from mandatory to voluntary. 
Another Nobel Prize winner wrote: 
Philosophically. I am most in sympathy 
with the propos^ guidelines in the December 
4 Federal Raigistar. Certainly, in hindsight, 
such guidelines are all that should have been 
present when recombinant DNA work was 
just beginning. However, now that we have 
had the history of the last years and the 
public concern about recombinant DNA I 
question whether we can go back to 
essentially no regulation. I believe that we 
cannot and need some mechanism to protect 
in the future both the Infant genetic 
engineering Industry and academic work with 
recombinant DNA. Therefore. I support a 
revision like that of Dr. Gottesman described 
in the December 7 Federal Register. 
As noted above in Part II-A of this 
announcement, the RAC at their 
February 8-9. 1982, meeting 
recommended that the Gottesman 
proposal be adopted. My response is 
given in Parts U-B and IV of this 
announcement. 
Both the December 4 and December 7 
Proposals Co Too Far 
Ten commentators felt not only the 
December 4 proposal, but even the 
December 7 proposal, went too far in the 
direction of relaxing the Guidelines. 
The Chairman to the IBC of the 
Harvard Medical Area, speaking for the 
IBC, wrote: 
It is our concern that the relaxation of the 
NIH Guidelines would lead some local 
communities to regulate this activity with 
different standards. The impact of such an 
occurrence could be devastating to the 
sdentific community and the public in the 
long term ’ * * It is our committee's opinion 
that a relaxation such as the ones beirtg 
proposed will create many problems. 
The Chairman of the IBC of the 
Harvard University Faculty of Arts and 
Sciences wrote; 
Although not quite unanimous, the majority 
of members carried reservations concerning 
some of the changes being proposed. Of 
utmost concern was the speed with which the 
relaxation is being considered. 
A letter on behalf of the Boston. 
Massachusetts. Biohazards Committee 
stated; 
’ * * we wish to indicate our strong 
disagreement to the three current proposals 
for revision of existing guidelines for RDNA 
research (Baltimore-Campbell. RAC and 
Gottesman) which appeared in the Federal 
Register of December 4. and 7, 1981. We 
support the continued measured and 
reasonable improvement in the current 
guidelines, but we believe that the current 
proposals in their present form are not 
consistent with this aim. 
Another commentator wrote: 
I would much prefer to see the RAC carry 
out a full review of its policy of the last three 
years of progressively dismantling controls, 
and to decide to strengthen the guidelines 
Another commentator wrote: 
I favor continuation of the present 
Guidelines writh their capacity for evolution; I 
would accept the Gottesman revisions as the 
"lesser-of-two-evlls" but do not endorse 
them. 
1 note that the RAC carefully 
considered the points made in these 
letters, but they were more convinced 
by the arguments made in support of the 
Gottesman proposal. 1 concur with this 
analysis. 
Special Concern for Maintaining the 
Role of Institutional Biosafety 
Committees 
One letter sent by the three 
Congressmen, all members of the 
Committee on Science and Technology, 
raised concerns about the September 
1981 RAC proposal. They wrote: 
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