17 
DR. FREDRICKSON: Fine. 
Mr. Hutt. 
MR. HUTT: I could find no procedure in the proposal, Don, as to how 
this entire process would be carried out, and in view of the admitted dif- 
ficulty of defining what is and what is not novel, particularly what Bob 
just said, it would seem terribly important that the Guidelines contain 
a detailed procedure that the list — which I think is an excellent idea — 
of exempt, non-novel experiments be set out for public comment before it 
would be adopted so that the scientific community could either agree or 
disagree . 
DR. FREDRICKSON: Yes, Dr. Ahmed? 
DR. AHMED: I have one question about the synthetic DNA molecules with 
respect to the NIH Guidelines. Have you given any thought to when such 
guidelines apply to such a — what you call constructing and handling? For 
example, if a chemist, not a molecular biologist, is constructing a DNA 
molecule synthetically, and it is not really at the stage of exchanging 
in the biological system, do the NIH Guidelines apply then? When will the 
NIH Guidelines apply? That is the question I have, basically. Have you 
given that much thought? 
DR. FREDRICKSON: Dr. Littlefield, can you comment on that? 
DR. LITTLEFIELD: I think we would like to have guidelines apply only 
when the material is in a living organism, but not when it is outside. 
DR. AHMED: The question I am trying to raise, I guess by implica- 
tion, is that suppose you did produce a synthetic DNA that may have certain 
replicative potential and have certain properties. Well, then what? Un- 
less you end up in a biological setting, it is not much of a problem, is 
it? 
DR. FREDRICKSON: I think that is a question that can be addressed 
right here. Dr. Singer, do you want to comment on that? 
DR. SINGER: Yes. I would start out by saying that the answer to the 
second question, in my judgment, is no. I would just repeat what Dr. Little- 
field said, that the first sentence of the definition, I think, makes it 
very clear that such molecules in a purely chemical setting are not covered 
by the items in this document. 
DR. FREDRICKSON: I take it that the import here is that the creation 
of a synthetic DNA is such an enormously common process in a wide variety 
of activities in molecular biology and biochemistry that only a very small 
number of those might involve attempting to put that synthetic gene into an 
organism. Is that it? 
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