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Founded 1938 Under Auspices of National Research Council 
October 26, 1976 
Dr. Donald S. Fredrickson 
Director 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Thank you for the materials on recombinant DNA 
molecules recently submitted to us. We are 
pleased to learn that you have determined to seek 
the advice of the industrial community in this new 
and complex field of research. 
As you know. Industry has an excellent record of safe 
handling of pathogens and other toxic agents. Although 
I can not speak for all of industry or even all members 
of the Industrial Research Institute, I believe that 
I.R.I. member companies engaged in this research effort 
will comply with the NIH guidelines relevant to physical 
and biological containment. 
With respect to your guidelines for DNA recombinant 
research, I want to take this opportunity to point out 
several problems which are of concern. The first 
problem Is one of assuring industry that the con- 
fidentiality of its research and development efforts 
will be protected. If the guidelines were to be 
followed totally, a great deal of information on a 
company's research and development plans would have 
to be provided to an extramural advisory committee. 
Such information might then be subject to disclosure 
under the Freedom of Information Act or even through 
informal channels. Protection of trade secrets is an 
important incentive to research in all areas. 
A second problem concerns the limitation on size of 
experiment. As currently worded, the specification 
is cause for concern among some of our member companies , 
and requires additional discussion before the guidelines 
are finalized. 
Finally, there is the question of commercial development 
of government-funded inventions in this area. We are 
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V. 
