DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
NATIONAL CANCER INSTITUTE 
September 12, 1978 
Dr. Donald Fredrickson 
Director, NIH 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
I would like to comment on the Proposed Revised Guidelines for recombinant 
DNA research. The proposed reduction in some of the excessive controls and 
restrictions on this kind of work is amply justified by all information avail- 
able. These changes in the Guidelines will no doubt facilitate and accelerate 
the application of recombinant DNA technology to many important projects in 
basic and applied research without creating any hazard to workers or the 
general population. 
I would like to urge that serious considerations be given to the possibility 
of further reducing regulatory levels in this area. In practice it would pro- 
bably be most effective if the Proposed Guidelines were put in force while the 
possibility of further changes is considered. From all information available, 
much of which is referred to in the Proposed Guidelines, it is clear that no 
single documented fact has come to light that would actually show any hazard 
deriving from recombinant DNA or organisms harboring such DNA. Further, on the 
basis of existing knowledge it is very difficult to construct a logical scenario 
of a dangerous situation. Given these facts one must question on general grounds 
the need for regulation of these activities. In particular, it would seem quite 
clear that characterized cloned eukaryotic DNA elements in E. coli pose no 
conceivable hazard. I would like to suggest that consideration be given to a 
change in the Guidelines so that institutional biohazard committees would be 
empowered to exempt characterized clones from further regulation. Such action 
would be most appropriate on the basis of known facts and would reduce the 
regulatory burden on all parties concerned. 
Sincerely yours, 
Igor B. Dawid , Ph.D. 
Head, Developmental Biochemistry Section 
Laboratory of Biochemistry 
[A— 122] 
