96 
would like to have some other control that you forgot to write to ask them 
for. So some of the specification of tests is going to have to continue to 
evo lve . 
DR. FREDRICKSON: Are there any other comments or questions? 
DR. HELINSKI: If someone wants to develop B. subtilis as HVl, then 
you have to worry about spores, which you don't have to worry about with 
E. coli . If you want to develop Streptomyces as an HVl, then you have to 
worry about mycelia versus single cells. So it is very difficult to come 
up with a generalized set of criteria that would apply to all organisms. 
I think it is best, in a sense, to put the initiative on the investigator 
first to come up with what he or she feels are reasonable criteria, and 
then have an expert group evaluate this. 
MR. HELMS: Is a record left behind from that process than can be 
examined by anyone who thinks it is inadequate? 
DR. FREDRICKSON: Dr. Gartland. 
DR. GARTLAND: Are you referring to the criteria for the — 
MR. HELMS: Yes, in other words, when you send in and you say I want 
this to be an HV2 system, and Dr. Gottesman says, "Well, I wish you had per- 
formed these tests and reported to us as follows," and you do that, is that all 
housed somewhere and exposed to the public view, should anyone wish to — ? 
DR. GARTLAND: Yes, let me explain. The protocols for testing an EK2 
phage and plasmid system are written up. They are a matter of record. They 
are in the process of being published in the Recombinant DNA Technical Bulle- 
t in , and the first issue is going to have an article on the phage systems. 
All the other systems are certainly available and documented in our files, 
and they also will be published in the Bulletin when decisions are made. 
DR. FREDRICKSON: Yes, we intend to keep a clear public record of that 
activity. I would want to correct, though, when you said "HV systems." 
Clearly we are not dealing in that HV terminology yet. These are proposed 
revisions, just for clarification. 
MR. HELMS: Of course. 
DR. FREDRICKSON: Mr. Hutt. 
MR. HUTT: Is it fair to ask Bob Sinsheimer, upon listening to what Bob 
Bock has suggested in terms of objective criteria, whether you think that 
would solve some of your difficulty in this area, and whether you think it is 
a feasible approach? 
DR. SINSHEIMER: Well, it would certainly be helpful, and I should think 
it would be feasible. It doesn't entirely relieve my concern, because the 
concern is not merely what is the pathogenicity, let us say of E. coli K-12 
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