Director, ORDA 
2 
January 21, 1982 
inadequate for the institution to leave responsibility for 
safety regulations entirely in the hands of individuals in- 
volved in the work. The potential conflict of interest is 
unreasonable, and is inunediately obvious to the surrounding 
community even when it is not obvious to the institution or 
the individuals. For these reasons, we think Institutional 
Biosafety Committees should remain mandatory. For the same 
reasons, we support the continued requirement that such com- 
mittees include at least two members who "represent the 
interests of the surrounding community," Such members give 
local communities a "window" through which to assess an in- 
dustry's impact on local health and environment in a reasoned 
manner, and simply by their presence can provide a healthy 
balance to the deliberations of a safety committee. 
We realize that in many institutions Biosafety Committees 
have had little work and will have even less if the Guidelines 
are further simplified. We believe, however, that IBC review 
is essential for recombinant DNA use involving disease-causing 
agents or the generation of toxins or pharmacological ly-active 
substances. IBC's without such issues to review could either 
not meet, or could profitably direct their attention to the 
other potential biological hazards of their institution 
(radioactivity, toxic chemicals, etc.). 
The other changes proposed in the December 4 Federal 
Register essentially abolish the present regulatory structure. 
Although the periodic revisions of the Guidelines have been 
moving slowly in this direction, we think such a marked accel- 
eration of this trend is unreasonable. The well-intentioned 
mistakes of the general scientific and technical community on 
other issues have left many people in Cambridge (and perhaps 
elsewhere) cynical about scientists' abilities to extrapolate 
very far beyond their immediate past experience, particularly 
if the scientists' own self-interest is involved. For example, 
it seems unreasonable to us to have only an admonition against 
deliberate release into the environment of organisms containing 
recombinant genes for antibiotic resistance and harmful toxins. 
It also seems unreasonable to abolish the Guidelines for bio- 
logical containment and at the same time make the Guidelines 
for physical containment mere recommendations. Finally, we 
think that elimination of the voluntary compliance program will 
leave institutions that use recombinant DNA without NIH funding 
in a peculiar position. 
Our own perception is that the measured evolution of the 
Guidelines has been a model of the way new technologies can be 
introduced into densely populated areas with maximum safety 
and public reassurance. To abandon this process now would be 
( 685 ) 
