Director, Office of Recombinant DNA Activities 
May 25, 1984 
Page 2 
There is an urgent need to circumscribe and define the mission. 
Recommendation No. 3 is too broad, particularly in the context of including 
all forms of genetically engineered organisms created by any and all tech- 
niques, including protoplast fusion, chemical mutation, and other procedures." 
Aside from expense, all inclusive regulations would require countless hours 
of time on the parts of review bodies (possibly on national, state, and 
local levels) and stifle technology and the advancement of knowledge. 
Review would depend upon a quantitative or semiquantitative estimate of 
risk/benefit in many situations where risk/benefit cannot be estimated. 
There should be a clear statement excluding from consideration by any 
panel of release of organisms where the ability to predict accurately 
the specific effects is not only extremely difficult but, in fact, 
impossible. 
(4) It seems appropriate for the task force to first establish the 
need for oversight of research scale releases. Such oversight might be 
found unnecessary. There appears to be no need for EPA to extend its 
authority with additional regulations. 
(5) For recombinant DNA research, NIH has been the appropriate agency 
for approving proposals for deliberate release from commercial biotech- 
nology companies. There appears to be no need for changing this practice. 
(6) The composition of RAC has not deliberately excluded individuals 
specifically trained in ecology and the environmental sciences. There 
appears to be sufficient expertise to consider environmental questions. 
Therefore, the present procedures (see Section IV-C-2) for choosing members 
appear to be satisfactory and do not need change. 
It is felt that the federal government regulates enough activities, 
including those in the biological sciences. Further regulation would 
extend to trivial applications and tend to inhibit, rather than to foster, 
original scientific research. This would impede development of useful 
knowledge and delay or prevent benefits to mankind. 
Sincerely yours 
Saul Kit, Ph. D., Professor and Head 
YM»vv 
Malon Kit, M. D. , Assistant Professor 
David Trkula, Ph. D. , Assistant Professor 
DIVISION OF BIOCHEMICAL VIROLOGY 
SK, MK, DT: gb 
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