SLOAN-KETTERING INSTITUTE for GANGER RESEARCH 
November 30, 1979 
Secretary Patricia Harris 
Department of HEW 
Washington, D.C. 
Dear Secretary Harris: 
As you know, the NIH has the responsibility for regulating recombinant 
DNA activities in order to protect the public. I want to draw your attention 
to an important change in philosophic approach which is currently taking place 
in the NIH with respect to public risks. This change is embodied in a pro- 
posed amendment to the Guidelines which will come before the Recombinant DNA 
Advisory Committee (RAC) in December 1979. The amendment, proposed by Dr. Novick, 
would sanction (ex post facto) the recent action of the RAC in exempting a large 
number of current recombinant DNA activities from the Guidelines without waiting 
for the results of risk-assessment tests now in progress and without full evalua- 
tion of existing data that many scientists consider to indicate potential danger. 
The proposal would make the work of the RAC easier by officially eliminating the 
problems of human ignorance and oversight and limiting regulation to cases where 
there is a clearly perceived and definable hazard. Even there, no mechanism 
has been established to ensure that well-established dangers will come to light 
before approval and widespread use of new techniques. 
The problem is that very little is known about these new genetic engineering 
techniques and their possible impact on man and the ecosystem. Howard Green, 
Professor of Law at George Washington University, has made the following comment 
apropos of recombinant DNA technology. "Comparable problems of balancing benefits 
against risks are found in many other areas in which science and technology are 
advancing. One element that is comnon to all of these areas is the fact that 
benefits are always relatively obvious, immediate, and intensely desired, while 
risks are usually relatively remote and speculative. There is, moreover, usually 
no constituency for the risks - very few people have the knowledge, resources, 
or incentive to press the risks upon decision-makers. Our major need is to find 
means through which risks are given time and dignity more equal to that given to 
benefits in the decision-making process". Professor Harvey Brooks of Harvard, 
Chairman of the Congressional Panel on the Health of the Scientific and Technologi- 
cal Enterprise, has also commented that "Until recently, society has acted on the 
principle that new technology should be assumed innocent until proven guilty. This 
was reasonable when technology was less powerful than it is today, but with time 
the price has crept up and the burden of proof has shifted much more onto the 
advocates of the introduction or diffusion of technology. Lack of evidence of 
side effects may now be sufficient reason for deferring a project whose possible 
secondary effects are not fully known or understood." 
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RESEARCH UNIT OF MEMORIAL SLOAN-KETTERING CANCER CENTER 
