18 
DR. AHMED: I understand what you are saying, but I would still like 
to raise the issue. 
DR. FREDRICKSON: Right. Are there other comments by the Committee? 
If not, we will have ample opportunity to continue this discussion 
as we hear now from several of the invited witnesses, each of whom is, 
please, again, urged to keep their presentation to within five minutes. 
Should anyone be tempted to go over that, I shall have to give a 30-second 
warning . 
The first witness is Dr. Ronald Cape, who is President of the Cetus 
Corporation in Berkeley, California. Dr. Cape. 
DR. CAPE: Thank you, Dr. Fredrickson. We have several general obser- 
vations, and some specific comments about the proposed revised Guidelines 
which we will bring up at the appropriate time later. I am accompanied by 
Dr. David Gelfand, who is Director of Recombinant Molecular Research at 
Cetus Corporation, and he will supplement some of my remarks. 
First, I notice my name tag says "Industrial Research," but I don't 
presume — we don't talk for industry in any general sense. The views I am 
going to express reflect the viewpoint of our company. Perhaps — no, I will 
say hopefully — others agree with us, but we have not consulted with anybody 
else in preparation of these remarks. 
Our major concern is that these Guidelines and their proposed revi- 
sions do not refer to our operations. That is right. We share the con- 
cern of others that since we don't receive grants from NIH or any other 
government agency, nor do we fund or subsidize work in government-financed 
laboratories, we and others like us in the private sector have no formal 
standing. The NIH Guidelines are the only recognized operating procedures 
governing recombinant DNA work, so for us they are like an operating manual 
— the only way to conduct this work. It is unthinkable to behave otherwise. 
Presumably others in the private sector share this commitment. 
However, consider our position. Since NIH does not provide our funds, 
there is no review process regarding our plans, our protocols, our contain- 
ment, and so forth. What does this mean? It means that we can't officially, 
formally interact with or enlist the assistance of our government in adher- 
ing, as we are committed to do, to the NIH Guidelines. What we want is 
diplomatic recognition. Inadvertently, I am sure, the private sector is 
somehow beyond the pale. We have no structure and no formal basis on which 
to relate to the NIH Guidelines. This is not — I repeat — this is not a 
source of satisfaction to us. 
Some people have suggested that this represents a reason for concern, 
and they suggest that industry is going to exploit this loophole. Far 
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