June 14, 1979 
Dr. Donald Frederickson, Director 
National Institute of Health 
9000 Rockville Peak 
Bethesda, MD 20205 
Dear Dr. Frederickson: 
In 1973 members of this research conference on Nucleic Acids were the 
first to draw attention to the possibility of biohazards arising from the 
dawning techniques of recombinant DNA. 
In 1977 when evidence was mounting of the inherent safety of such experi- 
ments, this group warned against excessive government regulation, lest 
freedom of inquiry be stifled and the benefits of the research to society 
be lost. 
Now, with the principal risk assessment studies completed, evidence of 
safety has become so strong that recombinant DNA experiments in the EL coli 
K12 host clearly do not pose an extraordinary risk. They should now be 
considered ordinary research, for which voluntary application of appropriate 
laboratory practices by the investigator has always been considered sufficient. 
We therefore strongly support the proposal by Recombinant DNA Advisory 
Committee members Wallace Rowe and Allan Campbell to exempt this class of 
experiments from the N.I.H. Guidelines, retaining, of course, the pro- 
hibition of specific experiments considered potentially hazardous (Federal 
Register 44, 22315 (1979). 
It is in the public interest to eliminate the ponderous burden of bureau- 
cratic registration, regulation and prior restraint from this field of 
research. Current regulations have generated paperwork that has discour- 
aged innovation, delayed, perhaps prevented, scientific advances, and 
escalated costs out of proportion to benefit if any. We are concerned with 
the tendency for bureaucracy to perpetuate itself. The evidence should be 
weighed and reweighed but unless an actual hazard can be identified, there 
is no sound justification for continued regulation. In this case, we 
recommend that the Rowe-Campbell proposal be adopted so that the require- 
ment for an M.U.A. for these experiments will be ended. 
(Signed) 
Kan Agarwal 
Dr. David Apirion 
Minou Bina 
Frederick R. Blattner 
Thomas R. Broker 
University of Chicago 
Washington University 
National Institutes of Health 
University of Wisconsin-Madison 
Cold Spring Harbor Lab. 
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