Dr. William J. Gartland 
January 29, 1982 
Page 2 
pathology as well as risk assessment test results have indicated 
no more demonstrable hazard than that expected for the organisms 
from which the recombinant DNA is derived. Consequently, Lilly 
recommends that the current Baltimore/Campbell proposal and Dr. 
Gottesman's recommendations be given careful consideration. 
As the company's experience with recombinant technology has 
progressed and both risk assessment and environmental monitoring 
data have accumulated (some from our own studies on host-vector 
systems for large scale use), we have come to view the constraints 
of the current NIH guidelines with some apprehension. It is now 
apparent that the broad background of four decades of experience 
in antibiotic fermentation is, indeed, applicable to large scale 
production of recombinant organisms and that the evidence of 
responsible conduct of that component of industry strongly 
supports the idea of converting the guidelines to a code of 
standard practice. Thus, philosophically, the status of this new 
technology would be returned to that which has been recognized as 
appropriate throughout more than a century of research on patho- 
genic bacteria and viruses. We view recombinant DNA experiments 
in this same light and conclude that formal controls over this 
activity do not serve a useful purpose. Although research may 
involve consideration of nearly all possible contingencies, it 
precludes certainty as to their occurrence; therefore, research 
in any scientific field always proceeds with some unknown elements 
of risk. However, by the time production status is achieved for 
a recombinant DNA or other product, those elements are no longer 
unknown, and the design and utilization of production facilities 
proceeds on the basis of better identified and tolerable risks, 
if any. 
Company personnel have not explored the total cost of compliance 
with the guidelines for the past five years in detail, but it 
is readily apparent that compliance has involved hundreds of 
thousands of dollars spent on containment facilities for 
experiments which can now be conducted in an ordinary micro- 
biological laboratory — plus several man-years of scientists' 
and other support personnel time spent in preparing, 
distributing, receiving, reading, and filing documents, 
conducting and participating in company and national meetings, 
all with concurrent travel and communications efforts. The 
Baltimore/Campbell proposal appears to embody a logical 
transition to decreased controls in this area. 
We believe that responsible scientists in academic institutions 
and other organizations receiving NIH grants, can and will follow 
the guidelines on a voluntary basis. Should NIH receive informa- 
tion that a specific grantee is not conducting recombinant DNA 
research in a responsible manner, NIH can still exercise 
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