195 
There is great need to clarify the difference between "shall" and 
"should" in these guidelines, and I won't dwell on that, because I perceived 
it as different from the drafting committee, and I think any lawyer would. 
There is a need to include things from the minutes that were not in- 
cluded, such as what happens in the procedural mechanism for determining 
what happens to the existing material that could no longer be used. 
There must be clarification of how EK2 gets approved. We went into 
that yesterday. 
Frankly, I think I will simply omit the rest on this list in view of 
the limits of time, but there is some drafting work that seems advisable. 
Let me talk now about probably the issue that more people have raised 
and expressed concern about than any other, at least those of us from the 
public sector, or the private sector, member of the public. 
(Laughter. ) 
We are all worried about proliferation of laboratories and experiments 
and loss of control over this entire process. No one is concerned, I think, 
about the laboratories that are represented in this room from the leading 
institutions and medical schools, and so on. We are concerned — and it was 
crystallized in the form of what will happen in the local high school labo- 
ratory. Perhaps it was unfortunate that we used that example, but that was 
intended simply to illustrate a concern about the problem. 
These guides would only be enforceable, whether they are regulations or 
guidelines or laws, they would only be enforceable by denial of NIH funds. 
They would not apply to industry, to foundations, to high schools, to many, 
many colleges and other instituions. I think it highly unlikely that the 
American public would allow that situtation to exist in light of these 
concerns . 
If these go no further than that, and if the work of all that has gone 
forward to date rests at that point, I think it highly likely that Congress 
would be forced to deal with this issue. The question then is, is there 
something further that could be done to broaden the scope of the regulation 
without opening up Pandora's Box of a rigid governmental control at all 
levels of development in this area. 
Don, I am sorry, I am going to go on a few more minutes. I realize I 
am taking more than my allotted 5 minutes. 
Now, there are various regulatory models in my judgment that could be 
considered. At one extreme, and I will say I personally do not agree with 
it before I describe it, would be the type of control exercised by the Food 
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