MINUTES OF MEETING - March 6-7 
30 
on the earlier (November 14, 1979) draft which had been reviewed at the 
previous RAC meeting. Dr. Barkley reported that comments on the first 
draft fell into several broad areas: First, commentators were concerned 
that procedures for laboratory-scale operations appeared to be extended 
to large-scale operations. Second, it was suggested that validation pro- 
cedures be clarified. Third, most commentators placed great emphasis on 
the containment capability of industrial fermentation vessels. The 
working group, therefore, attempted to treat the closed fermentation 
system as the fundamental aspect of containment in large-scale operations 
and attempted in its November 1979 draft to stipulate only two levels of 
containment, P2-LS and P3-LS. In response to comments, the working group 
subsequently concluded that establishing a Pl-LS containment level was 
appropriate. A fourth area addressed by commentators was the monitoring 
of containment systems. The working group felt it appropriate to establish 
monitoring requirements on systems that are actually employed. Fifth, the 
working group also recognized that more attention should be directed to 
health surveillance. The working group has recommended that health 
surveillance requirements be a specific recommendation for the P3-LS 
level . 
Dr. Walters suggested that the revised large-scale physical containment 
standards be published in the Federal Register for an additional period 
for comment. 
Dr. Krimsky said he would present what might be termed a minority report. 
He said that in his experience with regulation of new technologies at the 
level of production, the subpopulations at the greatest risk have little 
or no input into the decision-making process. In his view, it is the 
moral responsibility of those determining industrial standards to actively 
seek input from subgroups at potentially greater risk. Yet, his suggestion 
of bringing representatives of labor before the RAC was denied. He said 
that the revised standards do not reflect a sufficiently deep analysis 
of health surveillance. He felt strongly that the Committee should 
not be involved in what is tantamount to certifying industrial activities, 
but if the RAC is to be involved, labor should be represented and the 
RAC should interact directly with the Industrial Practices Subcommittee 
of the Federal Interagency Committee which has OSHA and NIOSH expertise. 
Dr. Young said he was concerned that the RAC is moving more towards a 
regulatory than an advisory mode. He said he believed the role of the 
RAC should be to be advisory on scientific principles. He expressed con- 
cern that the RAC would become a forum in which industrial procedures are 
"certified." 
Dr. Goldstein said he believed the RAC has exceeded its mandate; in a 
de facto fashion the RAC is regulating the private sector. He said the 
RAC does not possess the expertise to evaluate production aspects. 
[ 65 ] 
