Dr. Donald Fredrickson 
October 12, 1976 
Page 2 
This action has been justified on the grounds that since 
the research was already in progress, "the escape of potentially 
hazardous organisms was more likely in the absence of NIH 
action, jf that is the case, federally supported research 
conducted before publication of the guidelines would appear to 
have been technically illegal. It obviously cannot be used to 
justify further actions. That would establish a precedent which 
would make the operation of NEPA meaningless. 
The publication of the guidelines has been justified further 
through the claim that their "development . . . was in large part 
tantamount to conducting an environmental impact assessment . 
This claim is not justified because an essential element of the 
process required by NEPA has been lacking. 
NEPA requires consideration of "all reasonable courses of 
action, particularly those that might avoid adverse environmental 
effects . . . including, where relevant, those not within the 
existing authority of the responsible agency."'*'^ The process by 
which the guidelines have been formulated has effectively circum- 
vented this critical procedure. The only body that has had 
substantial impact on policy in this area has been the committee 
charged with the formulation of guidelines. But this committee 
was designed specifically as a technical rather than a policy- 
making body and has not considered policy alternatives explicitly 
However, it has assumed that the traditional mode of science, 
in which facilities proliferate and institutions compete in 
exploiting new and promising techniques, is also appropriate for 
this type of genetic manipulation. In the absence of action by 
any other decision-making body and in the presence of continuing 
research, a de facto policy of proliferation has come into 
existence . 
At the February 1976 hearing before your advisory committee, 
members of the public who attended and who had no involvement 
with the use of gene transplantation techniques either for them- 
selves or for laboratories in which they have an interest, were 
strongly critical of the present policy and the conditions under 
which it is being pursued. Furthermore, members of the committee 
such as Robert Sinsheimer, adopted a similar position. 5 Given 
your expressed desire to take into account the views of members 
of the public, we had hoped to see a thorough examination of 
policy issues initiated. In fact, the question of broad policy 
alternatives were not considered by the national guidelines 
committee, which met two months after the public hearing. That 
committee continued to make policy by default. 
A major argument that has been advanced to justify this 
continuation of the status quo has been that it "strike (s) a 
reasonable balance . . . between concerns to 'go slow' and those 
Appendix K — 31 
