25 
DR. FREDRICKSON: Thank you, Ms. Pfund. Will you wait there, please, 
for discussion by members of the Committee? 
I should simply comment, I think, in reference to your opening remark, 
that the Guidelines have not been revised downward, and that is the purpose 
of this hearing, to determine in what way the revisions should be made, if 
any . 
MS. PFUND: I didn't mean to say that these revisions are going to 
be accepted as they are, but the point is that when they were being dis- 
cussed and when these ideas were coming up, there was not the debate or 
the input from this diverse a group. 
DR. FREDRICKSON: I might ask whether Dr. Helinski, for example — and 
particularly he from the Recombinant Advisory Committee, which labored very 
long to provide these revisions and their justifications or rationale that 
you see in the Green Book--Dr. Helinski, would you like to comment on what 
Ms. Pfund has said, or do you reserve your time? 
DR. HELINSKI: I am sorry, comment on what? 
DR. FREDRICKSON: Have you a comment to make about new knowledge 
re levant — 
DR. HELINSKI: I think I would simply underscore what you have said, 
that there is always a question of what is the proper point for extensive 
public input in the case of revisions of guidelines. We have, as I will 
describe in some detail this afternoon, done our very best to obtain all 
the relevant information and new experimental data to support our proposed 
revisions. It was our intention to make this recommendation to the Director 
of the National Institutes of Health, knowing that this public hearing would 
be held to give everyone an opportunity to discuss the proposed revisions, 
and as provided in this Green Book, to consider the documentation for our 
proposed revisions. 
DR. FREDRICKSON: Mr. Hutt? 
MR. HUTT: Could you give us some idea, though, why the information 
in the Green Book was not put as the preamble to the Federal Register notice? 
I believe that is the point that Ms. Pfund is making. 
MS. PFUND: It is not just that. I mean, people rely on the Chang-Cohen 
experiment, they rely on the report from the Falmouth Conference, and I 
don't see that there is a consensus of opinion on these data. It just 
takes a few phone calls to certain scientists, to members of professional 
societies, to get comments on these experiments which don't make the 
grandiose conclusions that seem to proliferate here. 
MR. HUTT: Well, but at least, why all this material, which I think 
I certainly found very helpful — why that was not prepared ahead of time so 
that those reading the Federal Register would have that background. . . . 
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