266 
appear to be overly restrictive on the upper end of the scale. I think that 
I concur with one of the previous statements on that point of view. 
On the other hand, these proposed revisions might be too loose on the 
lower end of the scale, particularly if we don't know specifically what the 
dangers are. I am assuming here that we are taking a broader point of view, 
if we read the definition here at the beginning. It talks about the possibil- 
ity of adversely affecting the environment, which is a very general state- 
ment, not just the risk of infection. So all this applies specifically to 
that potential danger. 
So I feel somewhat uncomfortable with this relaxation of the Guidelines 
at the lower end. I guess that, at least, what one should attempt to do is 
to define properly what one means by novel or non-novel recombinant DNA. I 
think there is some confusion there, so that should be clarified. And from 
my point of view, it should be clarified if there is any doubt that a specific 
research project belongs or not — whether the Guidelines should apply in that 
case . 
I am also somewhat troubled, I guess, at the implications of incorpo- 
rating more experiments under this category. There seems to be a lot of 
bureaucracy that is implied by the fact that the Guidelines apply at all. 
So really, if it could be done, I would recommend that for the lowest con- 
tainments, Pl+EKl, the bureaucracy be simplified so that it is easier to 
carry out these experiments and, at the same time, to include more experi- 
ments which would otherwise not be under the Guidelines. So, if these two 
things happen together, I think that would be beneficial. 
Now, so much for general points. I have very few specific points to 
make, and I think most of them have been done already. Let me just stress 
once again that this definition of which experiments are actually under the 
Guidelines should be clarified. Perhaps another point worth mentioning is 
in connection with the statements of Dr. Schwartz, specifically referring to 
the fact that professionals in the risk assessment field should be involved, 
say, in the preparation of the Environmental Impact Statement. That probably 
does not apply any more to these revised Guidelines, but I hope in the future 
it will. It is just one of the interdisciplinary facts that other people 
should also be involved in these assessments. I am all for establishing 
training programs, and other points have already been mentioned. Let me 
mention one last point — which has not been brought up again — and that is 
the establishment of a data base. I realize it's very hard to state whether 
somebody is sick or not if you are trying to establish a very good data 
base, but it can really do no harm just to begin to collect data for future 
reference. From this point of view, it would be helpful if one could some- 
what extend the data base, covering not just the normal experiments under the 
Guidelines, but those now excluded in the revision. This would be a possi- 
bility to broaden the data base, facilitating later analysis. I think these 
are all the comments I have. 
DR. FREDRICKSON: Thank you very much. Dr. Molina. 
[ 470 ] 
