2 
of recombinant DNA molecules enters into a production phase. 
Dr. Fredrickson explained that the suggested legislation would grant 
the Secretary the discretion to determine when the regulatory function 
should pass from one agency to another. The Committee agreed that the 
Secretary should consult with appropriate regulatory bodies when making 
such a determination. 
Def lnit ions 
The Committee agreed that the definition of recombinant DNA molecules 
for the purposes of legislation should be that found in the NIH Guidelines, 
subject to change by the Recombinant DNA Molecule Program Advisory 
Committee, after public and scientific review and with the approval of 
the Secretary. Dr. Fredrickson also explained that the phrase "health 
and environment" Includes plant and animal life. 
Licensure 
Dr. Fredrickson explained that it is not the intent of the licensure 
provision to be used as a means of controlling agency obligations or 
of making judgments regarding the merit of a proposal. In case of a 
dispute over the determination of the containment level, as defined in 
the NIH Guidelines, the regulatory agency would make a determination 
subject to an appeals process which should be developed as the details 
of regulation are set forth. 
Registration 
There was general agreement by the Committee that registration of projects 
and other activities involving the use or production of recombinant DNA 
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