DEPARTMENT OF HEALTH & HUMAN SERVICES 
DEPARTMENT OF HEALTH & HUMAN 
National Institutes of Health 
National Heart, Lung, 
and Blood Institute 
Memorandum 
Date January 4, 1983 
From Acting Chairman, NIH Biosafety Committee 
Subject Comments on Revised Guidelines 
To 
Director, Office of Recombinant DNA Activities, NIH 
Under the revised Guidelines, the majority of experiments that are done at 
the NIH fall into the exempt class, III-D. As a result, the NIH Biosafety Committee 
had only two meetings in 1982 which dealt with experiments under III-B. The Committee 
met three times to consider containment for one experiment under III -A . 
There are no obvious problems with the revised Guidelines although with so many 
exempt experiments and the others falling in class III-B, our need to consult the 
Guidelines has been very limited. The one exception was the III -A case. 
The experiment under 1 1 1 -A took a great deal of the committee's time, but 
perhaps not an inappropriate amount because it was a difficult case (Dr. John 
Murphy's diphtheria toxin cloning). 
There have been no instances in which our committee has disagreed with the RAC 
regarding containment for a particular experiment. 
The Guidelines are neither too relaxed or too stringent. 
The NIH Biosafety Committee handles matters of safety other than Recombinant 
DNA research. 
In general, the few amendments to MUAs which we have considered have been poorly 
presented by the Pis and the members have had to be provided with and have had to 
reread the original MUAs. Perhaps it would be useful to have a standard form (as we 
did for Registration Documents) which would include information from the original 
MUA as well as the proposed changes in a concise fashion. 
Kira K. Lueders, Ph.D. 
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