16 
with each of these proposals on an ad hoc basis, and examine the record, 
and the arguments, and make a decision. 
DR. SPIZIZEN: That is correct. 
DR. FREDRICKSON: Now, ladies and gentlemen of the Committee, do you 
have some question or discussion about what you have just heard presented 
on the Guidelines? 
Dr „ Sinsheimer. 
DR,. SINSHEIMER: Don, I have two comments. One, that allowing for 
all the difficulties of semantics, I have trouble with the words "normal 
physiological processes," because I don't exactly know what is meant by 
"normal,," For example, it is not clear to me that it is normal in nature 
that E^ coli takes up DNA after being treated with calcium chloride, et 
cetera. Is that a normal physiological process? You can see what I am 
getting at. 
DR., FREDRICKSON: I do. 
DR. SINSHEIMER: And it seems to me that the definition therefore 
needs to refer somehow, some way, to be more quantitatively expressed: 
Something that occurs only under some very special condition or at some 
really wholly unknown frequency, would not be considered a normal physio- 
logical process. 
The second thing that concerns me again may be a semantic matter. It 
says, "In general, recombinant DNA molecules will not be considered novel 
when all the components are derived from genomes known to replicate within 
the organism." Once you have formed the genome, then that now can replicate 
within the organism. In other words, there is a possible progression here 
that I don't think is intended, but the wording would not exclude it. 
DR. FREDRICKSON: I wonder if, Dr. Littlefield and Dr. Singer, since 
you are sort of official hosts at the podium for this purpose, if you would 
care to exchange or comment upon the comments, please do so at each interval 
before you take another one. 
DR. LITTLEFIELD: I have a feeling it wouldn't be worthwhile. We 
had trouble enough writing this definition in a small committee. I would 
rather take these valuable suggestions back to the Committee and try again. 
DR. FREDRICKSON: I agree with you, that unless you feel a strong compul- 
sion or a need to intervene, that we should — 
DR. LITTLEFIELD: Maybe some of the members of the RAC would want to 
speak to this, but I would prefer to take these remarks back. 
[ 220 ] 
