3 
Licensure 
Dr. Lewis, USDA, wanted to be certain that the licensure provision of 
this suggested legislation would not be used as a means of controlling 
agency obligations or of making judgments regarding the merit of a proposal. 
Dr. Fredrickson assured him that this was not the intent. 
Dr. Lewis then asked for clarification of who shall determine the containment 
level at which a laboratory is licensed. Dr. Fredrickson explained that 
such a determination would be made by the funding agency, using the Guidelines 
as its standard, and that, in the case of a dispute, the regulatory agency 
would make the determination subject to an appeals process which should be 
developed as the details of regulation are set forth. 
Dr. Finklea, NIOSH, then offered as a motion that serious and willful 
violations of safety standards be punishable by loss of licensure. Ensuing 
discussion brought to light the possibility that all of the recombinant DNA 
activities being conducted within a licensed facility would have to be 
halted in the event of such a violation by a single individual. Rather 
than recommending this measure as part of the suggested elements for legis- 
lation, the Committee agreed that this matter be included in the section of 
the report devoted to Committee views. 
Registration 
There was general agreement by the Committee that registration of projects 
and other activities involving the use or production of recombinant DNA 
molecules was an important element of regulation. It was the consensus 
of the Committee that registration should occur prior to the initiation 
of the project, but that prior approval to commence the project should not 
be required. 
[ 268 ] 
