COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Three 
to the lowest level that can reasonably be achieved, that the 
level of risk to the public is extremely small, and that the 
potential benefits are substantial and are significantly greater 
than those risks. This principle has been embodied in all new 
public health and safety legislation for at least the past 20 
years, and prevades public opinion today. It is therefore 
essential that the preamble to the final guidelines be expanded 
to discuss the potential risks and benefits at length, to satisfy 
this "burden of proof." 
A number of the specific provisions in the guidelines 
raised substantial questions in my mind. Obviously, I am not 
technically trained and thus have no qualifications to determine 
the adequacy of or justification for many of these specific pro- 
visions. With respect to each of the provisions, however, it 
does seem clear to me that the preamble to the final guidelines 
must be expanded to deal directly with the issues that both non- 
scientists and scientists have raised. Again, this is one aspect 
of satisfying the burden on the scientific community to show to 
the public that a favorable benefit/risk ratio exists. 
At the meeting, there were, of course, strong views 
expressed both that the guidelines are too conservative and are 
too liberal. It is not sufficient, as you know, simply to say 
that the present draft of the guidelines must be about right, 
since the criticism from the opposing sides appears equally 
balanced. The "middle ground" approach is often fallacious. 
What is needed, instead, is a reasoned analysis of the views 
expressed by all who attended the meeting, a statement of the 
resolution of the issues that arose, and a specific rationale 
for the resolution of each such issue. All points of view were 
well-represented at that meeting and there was full opportunity 
for them to be stated and explained. All speakers seemed extremely 
well-intentioned, serious, and dedicated both toward the 
advancement of science and adequate protection of the public. 
Their specific concerns clearly deserve close attention by you, 
in articulating the results of your decision. 
Much of my probing during the meeting, as well as during 
the breaks, was designed to determine whether any aspect of the 
proposed guidelines was clearly unsupported or irrational. As 
I have already stated, it is not feasible for me to attempt to 
offer any specific technical recommendations on the scientific 
issues, beyond this very broad type of determination. On the 
basis of the material I have read and the discussion at the meet- 
ing, there are only a very few areas where I can offer specific 
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