Dr. Donald S. Fredrickson 
Page F our 
twenty or more years and would we be more secure? I submit that any 
bright graduate student could construct ominous and catastrophic scenarios 
with any known organism. Therefore, I believe quite strongly that the 
suggestion to defer recombinant DNA research until an entirely new 
host-vector system is developed will confront us with the same dilemma 
we face now and I challenge any group of scientists to provide evidence to 
the contrary. 
2. The guidelines as they are now worded are probably too inflexible; 
moreover, they are unnecessarily vague on how the flexibility the Com- 
mittee desired could be achieved. For example, at La Jolla the Committee 
agreed that study sections should be able to take into account novel research 
objectives and experimental designs in interpreting and implementing the 
guidelines. Already there are innovations in experimental procedures that 
provide novel kinds of containment over and above that mandated in the 
guidelines; where increased safety can be documented, I believe it is 
appropriate to permit scientific review bodies to allow changes in the type 
of conventional physical containment or even the stringency of the biolog- 
ical containment. These should be ad hoc , carefully considered and any 
such rulings and their bases should become part of the body of knowledge 
that can guide others. Any procedure that frustrates scientific genius and 
its innovations will thwart rather than promote progress towards achieving 
greater safety. Iron-clad regulations or complex licensing requirements 
that can be changed only by acts of Congress would, I believe, be destruc- 
tive rather than helpful. The only regulatory model I can now accept for 
monitoring or regulating recombinant DNA research in all possible settings 
is the one used for radioisotopes. Their sale, distribution, use and dis- 
posal are regulated for use in high schools, research labs, industry etc. 
Local committees, mandated and regulated by state and federal law, play 
a key role in monitoring compliance with safety regulations. 
3. The function of local biohazard committees may also need some 
review. The present recommendation was intended to minimize the need 
for expert scientific peer review at each and every institution where this 
work would be carried on. Thus the suggestion that only certification of 
the physical containment should be considered locally. But I can see that 
in many institutions there is the scientific competence to advise investi- 
gators on scientific matters, e. g. , experimental design, choice of host 
and vectors, assessment of risks etc. Such advice should not be admon- 
ished or discouraged when it is available; instead investigators should be 
encouraged to seek such advice from their local committees. 
Let me say once again how pleased I was for the opportunity to 
participate in the deliberations of your Advisory Committee's hearings. 
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