28 
MR. DACH: Dr. Fredrickson, I did not get a chance to inform Dr. McCarthy 
I would like to speak on this section, because it was just divided up on the 
new agenda, so I was wondering if I could have a few minutes to make some 
comments on the introduction. 
DR. FREDRICKSON: I am sorry; who are you? 
MR. DACH: Leslie Dach. I am one of the invited witnesses. 
DR. FREDRICKSON: Yes, you may, Mr. Dach, have five minutes. Are you 
Dr. Dach? 
MR. DACH: Mister. 
DR. FREDRICKSON: Mr. Dach, and would you introduce — you are from the 
Environmental Defense Fund? 
MR. DACH: The Environmental Defense Fund, yes. 
I would really like to second a lot of the things that Nancy has said, 
and to stress what she mentioned, that it is a misimpression to say that 
the definitions that emerged from the democratic process from the bills 
relied solely on novelty. The Senate bill, as she mentioned, did specifi- 
cally mention that no recombinant DNA molecule can be excluded from the 
Guidelines unless it is shown not to pose an unreasonable risk to health and 
safety. And the list of non-novel organisms that was included in the Senate 
bill was supposed to have been screened for safety in addition to novelty. 
The House bill also carries a much more restrictive definition of novelty 
than the proposed NIH definition in the revised Guidelines, and is much less 
ambiguous. The House definition refers more specifically to the exchange- 
ability of the DNA that goes into the recombinant DNA molecule with the host 
cell, which really seems to be the important issue here, and which is dealt 
with ambiguously in the Guidelines. 
On that same subject of vagueness, I would just like to point out 
here that the Guidelines were marred throughout by ambiguity and lack of 
clarity. They were obviously not written by people with any experience in 
enforcement. You can't enforce words like "normal physiological processes." 
You can't enforce words like "adequate care shall be taken." When the time 
comes to see whether someone has followed this or not, you just have no 
guideposts to do that with. Loose language creates loopholes. You can 
always come back later and say that it was unclear what it was I was sup- 
posed to do or what it was I was not supposed to do. As I said, that problem 
is pinpointed right at the beginning of the definition with the ambiguity 
that has been pointed out by a lot of the commentators between relying on 
exchangeability of the DNA molecule with a host organism, and in a previous 
sentence limiting the discussion simply to the DNA molecule itself. 
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