Page Two 
Dr. Fredrickson 
September 7, 1978 
area. Vinyl chloride was used ccrrmercially on a massive scale, with many 
workers and people living near plants being exposed to the material for many 
years, before it was recognized that this chemical is a potent carcinogen. 
One hopes that routine carcinogenicity testing is more cannon today than it 
was decades ago, but the point is that increasing knowledge based in part on 
past mistakes should lead us not to a false sense of security, but to a greater 
awareness of potential problems. There is no justification for weakening con- 
tainment guidelines at this time, after very limited experience in the field, 
except in those specific cases where it can be demonstrated that a lower level 
of containment would offer the same protection to the public. 
We would now like to consider Section IV of the Proposed Guildelines, "Roles 
and Responsibilities" . Of prime concern is the ecu po sition of the Institutional 
Biosafety Ccrrmittee (IBC) . The miniiruri requirement is for five people with 
"experience and expertise to assess the safety of proposed recombinant DNA 
research projects and any potential risks to public health or the environment" 
(P. 33085) . This is rather vague, given the fact that the IBC is delegated 
enormous power to lower restrictions, inspect facilities, approve planned 
experiments, and generally oversee the institution's activities in this area. 
If these local committees are to be given such sweeping authority, they must 
be constituted in such a way as to assure objectivity. 
We would suggest, for example, that the committee consist of seven members, 
with three having direct experience in disciplines relevant to recombinant 
DNA technology, one with experience in other areas of biological safety, one 
a nondoctoral person from a laboratory technical staff, and two representatives 
from the surrounding (non-academic) community. The latter two should have no 
other connection with the institution. Additional "experts" may be used as 
non- voting consultants. 
It is of particular importance that the IBC be shielded from institutional 
pressures because of the authority given them to approve experiments prior to 
NIH review, as well as the authority to lower containment levels. The only 
way to do this is to assure that a majority of the committee members not have 
a close relationship with recombinant D1SA research, and that some of the members 
not have any other connection at all with the institution. 
The IBC is given the duty of insuring that laboratory safety standards are being 
followed. The results of its "periodic inspections” (P. 33085, IV-A-3-a) must 
be made public. 
Sec. IV-A-4-o should be modified to mate it a requirement that containment pro- 
cedures be included in any publications, in part to discourage violation of the 
Guidelines through close peer review. 
[A-89] 
