105 
Many people have great interest in alternative, non -E. coli host- 
vector systems. That is clear. The pace at which we go ahead with those 
is obviously what is being discussed. And many of the reasons are docu- 
mented. Other people have made submissions, and I won't even repeat or 
refer to them. But we do have, and I have already stated this, a specific 
interest in these, for reasons firstly, that they may be the favorable way 
to get industrial production as one of the ult imate--and I am not specifying 
a time frame on this--raeans of getting some practical use out of recombinant 
DNA techniques, and there also may be safety factors. We would like to start 
to look into these alternative host-vector systems. 
I think it is important to be very clear that looking at survival, 
looking at survival in natural and non-natural environments, and trans- 
missibility, and disabling wild type organisms does not necessarily involve 
work with recombinant DNA. But certification of host-vector systems does 
involve communication of data to NIH. It is the only way you can do it now. 
Now, my questions are, Will NIH receive such data from industry? Will it 
certify such new systems from industry? Will NIH insist, as the proposed 
Guidelines reiterate, on distributing new host-vector systems to all quali- 
fied applicants for them? I think industry will want to know that. 
We need answers. We want contact and cooperation. That really is 
my major point. I think really right now we are out in the cold without 
any really clear way of handling that communication. 
DR. FREDRICKSON: Do you give the rest of your time to Gelfand? 
DR. CAPE: That is right. 
DR. FREDRICKSON: Do you have any further comments to make, Dr. Gelfand? 
DR. GELFAND: Yes, I do. I want to talk about alternate HV1 systems, 
alternate prokaryotic HV1 systems. We feel that one should not have to 
demonstrate lower survival in the natural environment. It is not clear 
what that means, first of all. If one is dealing, for example, with a 
St reptomyces that was first isolated many years ago in Europe or South 
America, does one have to go back to that soil in Europe or South America 
and attempt to re-isolate the same soil organism? We feel that if one 
is dealing with a nonpathogenic (for plant, human, and other animal) soil 
organism, and if in addition one is using nontransmi ss ib le vectors, if the 
host is nonpathogenic, and if the donor DNA had been isolated from a non- 
pathogenic, Class 1, etiologic agent, either a lower eukaryote or prokaryote, 
then there is absolutely no need for lower survivability for such an HV1 
system. 
DR. FREDRICKSON: Are there comments or questions for either Dr. Cape 
or Dr. Gelfand? 
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