31 
MR. DACH: No, I didn't mean to leave that impression. I mentioned 
them, though, to point out that the concept of safety was central rather 
than the concept of non-novelty. 
DR. FREDRICKSON: And the other point I would like to make, Mr. Dach, 
is that the record will be open for 30 more days and that I would urge both 
you and Ms. Pfund, who have directed some criticism at the development of 
the Guidelines with respect to the scientific information, to ask those 
scientists who have commented to you in regard to them to please supply us 
with the scientific background and their arguments, because it is on that 
basis that we will have to come to some conclusions about this definition. 
MR. DACH: I hope to be able to persuade them to do that. 
DR. FREDRICKSON: I think we are precisely on time for the coffee break, 
and we will adjourn for exactly 15 minutes. 
(Brief recess.) 
DR. FREDRICKSON: The Committee will come back to order to hear from 
public witnesses, the first of which is Dr. Arthur Schwartz from the Univer- 
sity of Michigan. Dr. Schwartz. 
DR. SCHWARTZ: Thank you. 
I just want to say a few words about the preamble, if you will. I 
think one problem is the lack of representation of dissenting opinion, and 
there was some. I think another problem is the lack of invitation to even 
participate to professionals in the field of risk-assessment outside the 
field of microbiology. Thirdly, I would like to simply reaffirm what I 
consider to be a big problem about the timing. Once a great deal of effort 
and expense has gone into the publication of a draft, the ability to revise 
it later on becomes very diminished, and I think a very good example of 
this process is with the Rasmussen report, the Reactor Safety Study 1400, 
which created a draft, but the public and dissenting input into the draft 
was largely ineffective in changing it once it was put out. 
DR. FREDRICKSON: Are there questions for Dr. Schwartz? 
Mr. Hutt? 
MR. HUTT: Dr. Schwartz, do you have any specifics about this lack 
of risk-assessment? 
DR. SCHWARTZ: Actually, I will be talking about the risk-assessment 
in the subsequent portions. 
MR. HUTT: Okay, fine. 
[ 235 ] 
