170 
MS. PFUND: Oh, yes. Allen Campbell here was Che chairman of the bio- 
hazards committee at the institution I attended, and I have talked to him 
several times about this. 
DR. FREDRICKSON: You talked to him. 
Mr. Hutt. 
MR. HUTT: I have one question in the nature of trying to understand 
your point, because I simply missed the point. You said you wanted a pro- 
vision for increasing in the P level under circumstances? I simply didn't 
catch it . 
MS. PFUND: I don't think I said that at any point. 
MR. HUTT: Maybe it wasn't an essential point. Let me go on to one 
other point. I will ask you privately later, because I missed one of the 
things that you went over quickly. 
You did talk about concern on exempting manufacture of large quantities 
for fear that this would lead to commercialization. I have proceeded under 
my legal interpretation, and I would like to know whether you have a different 
one, that when that occurs there are at least three and probably more regula- 
tory statutes that begin to apply, such as OSHA, the Toxic Substances Law, the 
Clean Air and Water Acts, the Food and Drug Act, et cetera. And that these 
Guidelines apply only to research qua research. The moment any aspect of 
commercialization occurs, it is blanketed by this myriad of Federal regulatory 
statutes that otherwise exist. Now, if your understanding is different, I 
would appreciate having it. 
MS. PFUND: Well, for one thing, I think there is an element of contro- 
versy in just how to establish the right mechanism for applying these agencies' 
regulations to private industry in this matter. I think that has come up in 
the hearings which have been held on this subject in the Congress. 
MR. HUTT: Yes, but I am talking about the current statutory provisions 
automatically apply if, for example, any of this were in any way purposely 
applied to a human being. It would be regarded by FDA as a drug which would 
be impermissible until there was approval by the Food and Drug Administration 
to do it. 
MS. PFUND: Okay, but you are not necessarily applying this to a human 
being when you are increasing the quantity of whatever it is you are pro- 
duc ing . 
MR. HUTT: Yes, 
Toxic Substances Act 
tection Agency prior 
but the moment you get to commercialization, under the 
you have to give notification to the Environmental Pro- 
to actually commercially producing it. 
My question is, Is my understanding of those provisions incorrect? 
[ 374 ] 
