167 
DR. FREDRICKSON: Right. 
DR. GOTTESMAN: Before DNA which was 99 percent pure could be worked 
with at a one-lower level than was set for shotgun experiments — 
DR. FREDRICKSON: You are talking about the old 1976 Guidelines on page 
27918? 
DR. GOTTESMAN: Yes. Okay, so pure DNA was in the 1976 Guidelines, 
allowed to be worked with at a lower level — although it was never entirely 
clear, I think, in the 1976 Guidelines, who made that decision that the DNA 
was 99 percent pure and who allowed that lower containment to be used. I 
think in practice it has been a local decision, made by the local biohazard 
committee, I guess, in most cases. 
DR. FREDRICKSON: Yes, it was a local decision, deliberately so, at 
that time. 
DR. GOTTESMAN: Okay; well, this one-step lowering for purified DNA 
which has been characterized — that rule is now also to be applied to purified 
clones, which of course are more than 99 percent pure, as well as chemically 
purified DNA. I think that is really what it amounts to, and then any further 
lowering to the levels that were allowed in the current Guidelines — that is, 
P2+EK1 for nonexchangers, and P1+EK1 for exchangers now--would continue to 
have to come to the Recombinant Advisory Committee. 
In addition, there has been a slight change in that we haven't mandated 
what level things can be lowered to by the Recombinant Advisory Committee, 
so in some cases they might now lower it all the way to P1+EK1, for instance. 
I don't know if that is terribly clear. 
DR. FREDRICKSON: I think this discussion is very helpful to me. It 
may not be to everyone else, because we are aware of this question. Trying 
to refer all these things centrally, this one question of a step-down deci- 
sion to the RAC or to NIH impresses me as being possibly technically impossi- 
ble. There are just too many decisions. But we would certainly, if we ves- 
ted that authority in the institutional biohazards committees, want to have 
a notification of that action to ORDA so that we are constantly maintaining 
a registry of where we are in regard to containment on these experiments. 
MR. DACH : I was wondering if I could get an answer to that question 
about why the experiments were--how the demarcation of the lines were be- 
tween the different physical — I mean, if that can be answered generally. 
DR. FREDRICKSON: I am sorry, would you repeat the question? 
MR. DACH: Maybe it is a naive question, and if it is I won't ask it 
again. I didn't get a conceptual feeling, and maybe I just need to have it 
explained to me again, for how finally the decision was made to slot, let's 
say, certain plant experiments in P3 versus P2. Was that based on specific 
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