4 
the public, arrf a notice of all deliberations should be published in the Federal 
Register . 
Mr. Mitchell asked whether the preposed review structure will deal with science 
as a unified whole or whether review will depend on proposed application and 
only be reviewed frem certain technical aspects. He asked whether risk appraisal 
would be separated from risk management. 
Mr. Mitchell said another consideration is vh ether the various agencies will 
have sufficient technical staff to evaluate the proposals and to organize and 
run the proposed advisory committees. 
Dr. McKinney felt the oversight scheme proposed in the December 31, 1984, Federal 
Register had not been carefully developed; a great deal of work is required to 
sort out various responsibilities and the ramifications of the proposed structure. 
For example, the Federal Register suggests the RAC would be called upon to 
interact with IEEA and EPA in order to provide advice and guidance in the 
scientific area. What then is the role of the NIH, a nonregulatory agency, in 
regulatory processes? 
Dr. McKinney said the Federal Register announcement caused him a great deal of 
concern; he questioned how the NIH would continue to pursue its mission under 
this proposed oversight scheme. The proposed schane may impose a heavy 
bureaucratic burden on NIH, and there is a real risk of losing the flexibility 
under which the NIH and researchers have functioned to date. 
Dr. McKinney said the Federal Register does not address several important 
issues. These include; what will be the fete of the NIH Guidelines for Research 
Involving Recombinant DNA Molecules under this proposed structure? Will each 
of the agencies develop their own set of guidelines? What will be the impact 
on local regulations such as those of Cambridge, Massachusetts, which mandate 
that the NIH Guidelines are the safety standards to be used within the locale? 
What will be the impact on other Federal agencies which have adopted the NIH 
Guidelines as their standards for safety? What wall be the fete of the NIH 
Guidelines if the regulatory agencies make them statutory? Will the NIH be 
unable to modify the NIH Guidelines without extensive hearings and legislative 
modifications in statutes? Flexibility in response to scientific information 
is one of the most important features of the NIH Guidelines. This feature, so 
important to the success of the NIH effort at oversight for recombinant DNA 
technology, may be lost under the proposed oversight scheme. 
Dr. McKinney said EPA clearly asks in the Federal Register announcement whether 
EPA should incorporate the NIH Guidelines into their legal rules. He suggested 
that if the NIH Guidelines become statutory, laboratory research may be faced 
with restrictions which do not currently exist, e.g., inspections. 
Dr. McKinney said the Federal Register announcement does not attempt to address 
the issue of where scientific research stops and commercial application begins. 
He thought the Federal Register as written suggests vaccine development projects 
carried cut by NIH institutes would fall under the purview of the regulatory 
agencies . 
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