273 
deficiencies in the so-called Guidelines, because the regulatory aspects of 
them have not, in my judgment, sufficiently been dealt with. 
As you know — and I won't go over this in any detail, because I don't 
want to take too much time — I have strongly believed, and stated on several 
occasions, that these should be put out under Section 361 of the Public 
Health Service Act. That provision of law provides ample legal authority. 
I have checked with other government attorneys who concur in my legal opinion 
on that. I even checked with the Food and Drug Administration, which said 
it has never given a contrary opinion, and with people there who concur with 
my judgment. They have put out several regulations comparable to this under 
Section 361 of the Public Health Service Act, and if it were illegal here, 
all of those regulations would presumably be illegal elsewhere. 
The problem that occurs if one does not do that is, in a sense, you are 
inviting OSHA, EPA, maybe the Consumer Product Safety Commission, and Lord 
knows who else, into what is otherwise a regulatory void. I think, as I 
said 18 months ago, that the scientific community and NIH deserve to be able 
to keep the lead in this area if indeed they take that responsibility. But 
if they step away from it, which in my judgment is happening when you don't 
use your legal opportunity here, then I think other people may well come in 
and take it away from you. And I personally would think that that would be 
a step backward, because I don't think those other agencies have the exper- 
tise that is here. 
Now, specific substantive issues I will leave, I believe, to a letter 
that I would be happy to send, except for one, and that is the issue of 
bringing industry under the Guidelines. I think it would be a very simple 
thing to do. There are problems of trade secrets, but those have not been a 
barr er to many other regulatory agencies that have faced the identical 
issue. If t. h • ■ ! ood and Drug Admins tr at ion has been able to handle trade 
secret data u.i^er the Investigational New Drug provisions since 1938, I 
would presume that we could find a way for NIH to do it under the DNA 
Guidelines . 
It is, I think, important that this be done in order to reassure the 
country that while these are nonetheless Guidelines, that everyone who has 
a major piece of the action in the research community is nonetheless bringing 
themselves under them. It is my understanding that the industry would be 
willing to do that. 
I have another specific suggestion as to how that could be assured. 
One way would be to have a specific requirement that any university that 
receives any Federal money would have to assure that all research on recom- 
binant DNA conducted by that academic institution would be subject to the 
Guidelines. That could be done by Executive Order, without the necessity of 
new legislation, and it would preclude the situation we heard discussed 
today, on which I have no independent knowledge, but assuming that that 
situation exists, that would certainly take care of it. 
[ 477 ] 
