Medical College of Georgia 
Augusta, Georgia 30912 
Biological Safety 
(404) 828-2663 
January 15, 1982 
Di rector 
Office of Recombinant DNA Activities 
Building 31, Room 4A52 
National Institutes of Health 
Bethesda, MO 20205 
Dear Sir: 
Having reviewed the recently proposed revisions in the NIH 
recombinant DNA Guidelines, I would like to make several 
comments. First, these NIH Guidelines have been amended on 
a rather frequent basis since they were initially developed. 
This no doubt has made life difficult for institutions which 
have sought to adopt these guidelines as the minimal standards 
for their Institutional Biosafety Committees (IBC's). However, 
it has been widely understood that NIH has made these changes 
as risk assessment data has become known and analyzed. This 
knowledge has been comforting and has made the revisions 
much easier to embrace. 
Another point which I would like to make concerns the efficency 
with which investigators dealing with recombinant DNA molecules 
has been able to be conducted in accordance with these guidelines. 
I have only been the biological safety officer at this institution 
for a very short time, but I have found that recombinant DNA 
research has generally been accomplished smoothly and safely 
within the structure recommended by the guidelines. Nonetheless, 
I have encountered investigators who would not have included 
certain safety considerations into their planning had they 
not been required to do so by the campus IBC and by NIH 
in order to receive their funding. No doubt this same situation 
has occurred at other institutions as well. 
Now I would like to link the previous two statements as they 
apply to the proposed revisions. The Recombinant DNA Advisory 
Committee (RAC) proposal would essentially take NIH out of the 
picture regarding the issuance of guidelines in this particular 
area of research. This action would be appropriate if all 
risk assessment determinations concerning recombinant DNA have 
been made. Although much more knowledge is now known than 
when these guidelines were originally drafted, some risk 
assessment research is still in progress and some has yet to be 
started. Under the RAC proposal, some institutions would 
automatically dismantle their IBC's and drop any sort of re- 
view of recombinant DNA research. Many responsible investigators 
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