19 
from it. Dr. Fredrickson. This loophole, if such it is, represents a double 
bind to industry. We have a firm public commitment to adhere to the Guide- 
lines and to do so scrupulously. But adhering involves a whole series 
of formal interactions with NIH, and paradoxically, in attempting to in- 
teract with NIH to adhere to the Guidelines, we find that the workings of 
bureaucracy are such that since we don't have grant applications, we can't, 
for example, have formal MUAs , Memoranda of Understanding and Agreement. We 
probably can't get NIH in the official manner to have their review groups 
and study sections consider our P3 plans, our biological containment plans 
and so forth. 
Mr. Chairman, help us to do what everybody wants us to do. Everyone 
in this room wants us to comply with the Guidelines. We want to. So what 
we are asking for is diplomatic recognition. If at first it can only be an 
ad hoc, de facto recognition through some temporary authority, somehow 
sought by and assumed by NIH in revised Guidelines, that will be a start. 
Ultimately we want de jure recognition. That is why we don't merely en- 
dorse a Federal law extending the Guidelines to everyone; we actively seek 
such a law. Again, as we have said in public subcommittee hearings in 
the Senate and in the House, we favor--among the various alternatives which 
have been presented — almost word for word, far and away we prefer the 
Interagency Committee's suggestions, the Interagency Committee chaired by 
yourself, and a report from which was submitted with some proposed recommen- 
dat ions . 
There are a couple of areas to which others will refer, so I won't take 
time to repeat what others will say. Clearly there are certain possible 
Catch-22 situations with respect to public disclosure. There certainly has 
to be — on the part of anyone adhering to the NIH Guidelines — frank and open 
communication with institutional biosafety committees, no question about 
it. But I think there is now general recognition that there has to be some 
clear designation of what formal but open and frank communication consti- 
tutes publication and what does not, so that there is not a precluding of 
possible subsequent patent applications. 
Lastly, I just want to refer to one other kind of activity that per- 
haps has not been fully considered, and that is the fact that we will 
want to develop alternative host-vector systems. They have many possible 
advantages and practicality, and what have you, and this also has to be 
considered in terms of the publication consideration. Thank you very much. 
DR. FREDRICKSON: Thank you, Dr. Cape. Remain at the podium, if you 
will, please. You went quite a bit beyond the introduction and defini- 
tion, but I hold that not against you: you were trying to make a point. 
I would permit now the Committee to question or discuss with Dr. Cape any 
of his comments. 
Mr. Helms. 
[ 223 ] 
