Attachment IV - Page 15 
I’AHT IV (Cont'd) 
Paqe Eleven 
would require a need for cooperation, communication and coordination 
between autonomous agencies. This would involve a mix of regulatory 
and non-regulatory agencies. 
It was the general consensus that decentralization could be 
satisfactory if indeed it is manageable; but if not manageable, 
such could result in not only confusion and uncertainty, but 
would perhaps result in an overload of the resources and failure 
of the system. A question was raised as to what other areas of 
governmental activity is there in place, or in which there has 
been actual experience which effectively coordinates the duties 
and responsibilities of autonomous agencies. 
Many future applications and issues will be multi-dimensional 
in nature. Not only multi-dimensional in a scientific sense, but 
also multi-dimensional in requiring social and value judgments. 
In order to obtain the full spectrum of viewpoints and expertise, 
a single agency approach would be more successful. It is diffi- 
cult to expect these complex, multi-dimensional issues to be 
adequately addressed in a system comprised of a loose federation 
of agencies. 
Whatever approach is adopted, it must retain the public 
confidence and trust. If a major incident or tragedy would occur, 
it is critical that there be an identifiable agency who bears 
responsibility and accountability. This accountability should 
not be defused throughout a dumber of agencies and/or individuals. 
Whatever mechanism is established, it must earn and retain 
the credibility of science investigators, their staffs and the 
university system itself. It is these individuals and universi- 
ties which must work with the system. If highly knowledgeable, 
expert scientific investigators do not have confidence in the 
system, this could prove to be detrimental to all concerned. 
It is also critical that industry have confidence in the 
system. Without such confidence, it is doubtful that there 
will be a meaningful and expending biotechnology system as is 
now anticipated. Both large and small companies must be able to 
make appropriate long-term plans for research and product develop- 
ment. Any mechanism must be such that it will remain in place 
over a protracted period of time. 
Although the federalization approach appears feasible and 
reasonable, there was doubt expressed that in practicality 6uch 
coul d effectively be coor cT Tn a t e c(T 
Another concern was that any substantial change in the 
existinq structure would perhaps result in a loss of continuity 
and cause delays in the process of research applications and 
the development of commercial products. 
[425] 
