MINUTES OF MEETING - June 5-6 
9 
Ms. King said that she was troubled by a compliance system where only some 
aspects of a situation are reviewed. She was basically opposed to certify- 
ing an application when no adequate means of ensuring compliance exists. 
She felt the RAC does not have the legal authority to regulate industry 
and said voluntary compliance, in her experience, is not a viable over- 
sight mechanism. She said, however, she found Dr. Gottesman's proposal 
preferable to the current situation. 
Dr. Campbell said he supported Dr. Gottesman's proposal. However, he 
shared the concerns that Dr. Baltimore voiced about infinite scale-up. 
He suggested that any recombinant organism that is propagated in very 
large volumes should be subjected to some type of testing in terms of 
toxicity, antigenicity, etc. 
Mr. Thornton said that by action of the RAC, and by approval by the 
Director, NIH, the charge to the RAC now includes oversight of a program 
of voluntary compliance. He stated that the U.S. system of government 
is based upon consent and that consent to be bound by the NIH Guidelines 
has been expressed. He hoped that changes from the current situation 
would be done by a orderly process. 
Dr. Novick said he would be comfortable supporting Dr. Gottesman's 
proposal if the RAC would go on record as endorsing, in principle, the 
bill introduced by Senator Stevenson's, S. 2234. Ms. King noted that 
the RAC had gone on record as supporting the concept of mandatory 
compliance. 
Dr. Young suggested that the RAC might adept language indicating that 
in the recommendation of scientific feasibility and levels of physical 
containment, the action of the RAC should not be construed as an 
industrial certification. 
Dr. Baltimore said that Dr. Gottesman's proposal, in the long term, 
would be an appropriate role for the RAC. However, he expressed concern 
that adoption of Dr. Gottesman's proposal, at the present time, would 
create a vacuum of oversight. Therefore, he proposed that Dr. Gottesman's 
proposal be forwarded to the Interagency Committee as RAC's view of a long- 
term goal. Ms. King said she shared Dr. Baltimore's concern for orderly 
process, but felt the RAC should begin definite orderly action towards its 
goal. 
Dr. Goldstein said that approximately a year ago the RAC indicated to the 
Director, NIH, that the RAC was uncertain of its role in voluntary ccrpl i- 
ance, and requested that other federal agencies be cane involved in this 
area. He said that the Federal Interagency Committee has convened several 
times since then, but has made no concrete proposals. Dr. Goldstein said 
the RAC should not continue in its present mode. He suggested that the 
surest mechanism to have the Interagency Committee assume responsibility 
is for RAC to disclaim any further responsibility. Dr. Baltimore said 
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