Dr. Donald S. Fredrickson 
January 13, 1978 
Page 2. 
conversion of E. Coli K-12 to an epidemic pathogen capable of infecting a human 
being- -has not been discussed sufficiently, and as such it is perhaps the weak 
point in the DNA controversy. Some experts appear to be convinced that this 
type of subtle hazards to the ecosystem are practically non-existing; they argue, 
for example, that recombinant DNA experiments merely duplicate events that 
occur extensively in nature. Others argue that the probability of creating harm- 
ful organisms which can survive, reproduce and adapt to the environment is 
greatly enhanced through this experiments. As an outsider to the field I cannot 
judge easily the scientific merits of each side of the argument. Is the current 
status of science in this field such that, indeed, very little, if anything, can be 
said about the seriousness of these risks? Or, are the risks so small that the 
scenarios involving appreciable perturbations to the ecosystem appear farfetched? 
In my opinion, the nature of the situation, which involves imposing an involuntary 
risk to society, demands that the burden of proof lie on those members of the 
scientific community who maintain that recombinant DNA research is quite safe; 
they should provide convincing scientific (besides emotional) arguments in their 
favor. The Environmental Impact Statement on the NIH guidelines (October 1977) 
contains a brief discussion of possible hazardous situations (Section IV-C, pp. 23- 
31), and clearly the possibility of a harmful outcome of recombinant DNA research 
is not ruled out in that document. It states, for example, that ’’current knowledge 
does not permit accurate assessment of whether such changes will be advanta- 
geous, detrimental, or neutral, and to what degree, when considering a particu- 
lar recombinant DNA experiment.” (p. 23). 
In terms of risk assessment, it is very difficult to deal with situations where the 
risk cannot be quantified, where even the very nature of the risk is not well 
defined, and where the probability of occurrence of an event harmful to the environ- 
ment is admittedly small, but the consequences potentially quite serious. The 
only reasonable course of action is to proceed with caution and to try to be alert 
to unforseen consequences. I am, of course, assuming that the benefits of carry- 
ing out recombinant DNA research are potentially very large; otherwise there 
would be no need for society to incur even a small risk. Furthermore , I am not 
considering other issues which surfaced during the December meeting, such as 
the possibility of deliberate misuse of knowledge acquired through this research; 
knowledge in almost all branches of science can also be potentially misused. 
What does all this imply in connection with the proposed revisions to the NIH 
guidelines? It seems to me that overall, the guidelines are drafted to a consid- 
erable extent from the point of view of protecting man from an epidemic, which 
is the hazard that now appears to have been exaggerated (perhaps the very pur- 
pose of the guidelines is not stated with sufficient clarity). Thus, the assignment 
of the various experiments to the many different categories appears somewhat 
arbitrary. In particular, the two extremes in the containment levels referred 
[Appendix A — 215] 
