COVINGTON 5. BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Five 
whether any risk assessment is possible. It is, of course, 
relatively easy to criticize any form of risk assessment, 
since this is a fairly new field and there are inherent 
uncertainties in analyzing a still-emerging area of research 
like recombinant DNA. I am not satisfied, however, with 
his suggestion that risk assessment in this area may well 
not be feasible. Even if definitive answers cannot be ob- 
tained, we must do the best that we can at this time. It 
is simply unacceptable to contend that, since definitive 
risk assessment is not feasible, all research on recombinant 
DNA molecules should cease; this would mean that the re- 
search needed to engage in more definitive risk assessment 
would itself be precluded. If Dr. Schwartz's approach were 
applied to all human endeavor, the progress of civilization 
would be substantially impeded if not halted for fear of un- 
known risks. 
The difficulty of risk assessment in this area is, 
on the other hand, one reason for continuing the policy of 
proceeding with caution on research with recombinant DNA 
molecules. As more becomes known, risk assessment will be- 
come less speculative and more reliable. 
Ill 
In general, I believe the process has been working 
exactly as one would have hoped. Faced with the realization 
that they carry the burden of showing to society that re- 
search on recombinant DNA molecules can be conducted without 
unreasonable risk, scientists have responded in their finest 
tradition. They have undertaken substantial research and 
analysis to demonstrate that the risk is small and that the 
potential benefits outweigh that risk. Those immediately 
involved in laboratory experimentation on recombinant DNA 
molecules have enlisted other scientists who can bring rele- 
vant data and information to bear on this matter. The result 
has been the development of a great deal more information 
bearing on the risks of this type of research than was avail- 
able, for example, at the time of the February 1976 meeting. 
From all of the information made available at the 
December 1977 meeting, I continue to concur that the poten- 
tial benefits of research on recombinant DNA molecules out- 
weigh the risks of this research. As you know, I supported 
the general thrust of the original draft Guidelines, while 
[Appendix A — 243] 
