The President 
Page Two 
We appreciate the great care NIH has taken, in the 
formulation of these strict guidelines, in obtaining the 
best scientific advice as well as advice from experts in 
law and ethics. Opportunity was also given for the public 
to comment on the guidelines. The environmental impact 
assessment of the guidelines currently being prepared by 
NIH will offer further opportunities for such comment. 
The guidelines will be widely discussed and debated 
with regard to their ultimate adequacy in safeguarding the 
public, and they will no doubt further evolve and develop 
during this debate and as our understanding of recombinant 
DNA advances. Based on the process by which NIH produced 
the present guidelines, we are confident they are a respon- 
sible and major step forward and reflect a sense of social 
responsibility on the part of the research community and 
the NIH. 
However, we are gravely concerned that these relatively 
stringent guidelines may not be implemented in all sectors 
of the domestic and international research communities and 
that the public will therefore be subjected to undue risks. 
The National Institutes of Health has the authority to require 
adherence to the guidelines as a condition of their grants 
and contracts for research, but they cannot enforce the guide- 
lines with respect to other Federal agencies, with respect to 
research in the private sector in this country, and with respect 
to research done in other nations. 
In particular, it is clear that recombinant DNA research 
has great potential in the private sector, such as pharma- 
ceutical manufacture, the oil industry and agricultural products. 
It is also clear that some elements of the guidelines, such 
as limitations on the size of experiments, public disclosure, 
and non-release of materials into the environment, may be 
contrary to the interest and practice of research in private 
industry, and may therefore be ignored. In addition, since 
private sector research will lead to industrial application, 
guidelines must be extended beyond research into application 
and production stages. If the NIH guidelines are necessary 
to protect the public in Federally funded research, it is 
clear they are necessary for privately funded research and 
application as well. 
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