Dr. Donald Fredrickson 
October 12, 1976 
Page 7 
It is clear that this possibility would curtail much gene 
transplantation work. On the other hand, it seems the only way 
to ensure that a disaster does not occur. It must be remembered 
that the "benefits" of work in this area will turn into "costs" 
should research release novel microbes which disrupt the balance 
of the biosphere, or infect its human components. 
Furthermore, we note that the order of procedure we recommend 
is in fact that which was prescribed in the charge to the NIH 
committee which has drawn up guidelines: 
The goal of the Committee is to investigate the current 
state of knowledge and technology regarding DNA recombinants, 
their survival in nature, and transferability to other 
organisms; to recommend programs of research to assess the 
possibility of spread of specific DNA recombinants and the 
possible hazards to public health and the environment; and 
to recommend guidelines on the basis of the research 
results . 
In fact, guidelines have appeared, but research aimed spe- 
cifically at defining the hazards is only just beginning. Why 
was the order of procedure reversed? There may be circumstances 
that explain this reversal. Nevertheless, this major change 
in policy was not decided by the public and now requires a public 
inquiry. 
III. Role of the public in the decision- 
making process 
Proliferation of gene transplantation work at this point 
means that a vast social and ecological experiment will be carried 
out on the public — without its informed consent. The Draft En- 
vironmental Impact Statement claims that the public participated 
in the decision-making process that resulted in the present 
policy. Let it be clear that providing input to a decision- 
making process is a quite different matter from participating in 
one. Decisions on gene transplantation policy have been made 
without representation from those who will be most at risk — for 
example, technicians, maintenance personnel, and graduate students, 
without representation from public interest and environmental 
groups, and without representation from the public at large. 
Through the mechanism of a technical committee, decision- 
making in this area has been concentrated in the hands of re- 
searchers and directors of research establishments, many of 
whom have a clear interest in gene transplantation techniques. 
The efforts of members of the committee and of other scientists 
in the field to control risks have been commendable. But it 
is questionable whether self-regulation of this type can be relied 
on as a means of making public policy. In areas of hazardous 
Appendix K — 36 
