270 
developed by NIH to do all kinds of risk assessment under proper guidelines, 
and that this should be conducted, and also should be somehow incorporated 
in future guidelines or in any revisions that you might consider. 
The lack of adequate data base, I think, again goes back to this very 
question of whether or not we are making judgments here on adequate scien- 
tific bases. 
So I would like to summarize my statement by saying that I think most 
of the issues that were dealt with in the last two days were basically the 
issues that have been dealt with on other controversial issues of a scien- 
tific nature in the past, not very different from it. And I hope that any 
solutions we seek to it should follow the same course of action. 
Any specific recommendation that I might make on the Guidelines, I will 
amplify in my written comments. 
DR. FREDRICKSON: Please do, Dr. Ahmed. Thank you. 
Mr. Peter Hutt I introduced yesterday. He is formerly Chief Counsel 
of FDA and Assistant General Counsel in that Department, and is now an 
attorney in Washington. 
Mr. Hutt. 
MR. HUTT: Well, to some extent this is a replay of some of the issues 
that we discussed in February of 1976. Interspersed with the issue of 
revision of the Guidelines, a number of witnesses have raised more basic 
points. Should there be any Guidelines at all? or, the opposite of that 
issue, should there be any DNA research at all? I took the position, and 
feel, if anything, as strongly or more strongly today, that the burden of 
proof for safety still rests on the scientific community. Don, in my letter 
in February of 1976 summarizing my views, there are two paragraphs that I 
think I ought to read on that, because from my standpoint they set the 
stage for determining to what extent you can revise the Guidelines. 
"The public is becoming far more sophisticated with respect to scien- 
tific issues than many in the scientific community recognize. There is wide 
understanding that absolute safety is not attainable and, in any event, is 
not provable. Thus, the term 'safety' is used by me and others, including 
Congress, to mean nothing more than a level of risk that is both reduced as 
far as is reasonably feasible under the circumstances, and does not outweigh 
the potential benefits. At the same time the public clearly expects that 
the burden of showing an acceptably low risk is on those who propose to pro- 
ceed with the projects involved, whether it be industry, academic scientists 
or other groups. 
"It is wholly insufficient, in my view, to argue that no harm has been 
proved. The burden is on the scientific community to prove to the public 
that the risks from research on recombinant DNA molecules have been reduced 
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