5 
Dr. McKinney called the attention of the working group to one item of the mandate 
of the Cabinet Council Working Group as stated in the December 31, 1984, Federal 
Register : "Review the function of the NIH Recombinant DNA Advisory Ccnmittee 
and its role in biotechnology commercialization and safety regulation." 
Dr. McKinney noted that although this item was part of the Cabinet Council 
Working Group mandate, the Federal Register announcement gives no indication 
that the function of the RAC had been considered. 
Dr. McKinney said RAC has several generations of experience in dealing with 
industry under the NIH Guidelines. This association began with the inclusion 
in the NIH Guidelines of a section on voluntary compliance. Nonetheless, the 
Federal Register announcement neglects this interaction and any useful informa- 
tion from this NIH-industry oversight effort. 
Dr. Lardy said he vas pleased by the US DA and FDA policy position statements 
in the December 31, 1984, Federal Register . These agencies indicate that 
products of recombinant DNA technology would be regulated in the same manner 
as products from other technolcg ies . He noted, however, that the stated mission 
of the EPA differs frcrm the missions of the USDA or FDA. He wondered how much 
effort would be required to prepare a PreManufacturing Notice (PMN) . He 
also questioned how burdensome the 90 day response period mandated by statute 
would be for the EPA. He said there is a great difference between simply 
recording proposals and reviewing and regulating. 
Dr. Landy said he would prefer the regulatory agencies address themselves to 
commercial applications. RAC and the NIH should continue to address research 
issues. In addition, RAC's mandate to determine whether recombinant ENA poses 
any risks should not be divided among other agencies. 
Dr. Friedman said RAC's experience in risk assessment in recombinant ENA should 
be taken into account in devising an oversight scheme. He noted that the EPA 
appears to raise concerns RAC successfully resolved years ago. He felt the Work- 
ing Group on Biotechnology Coordination should emphasize that RAC's experience 
and wisdom should be utilized. 
Dr. Friedman felt the decentralization of review preposed by the December 31, 
1984, Federal Register could be a good idea; however, the major question is 
vhether decentralization would be manageable or unmanageable. If the sole out- 
come of this decentralization scheme will be confusion and increased bureau- 
cracy, this scheme will fail . 
Dr. Levine said FDA ' s stated approach to the oversight of biolog icals is rational. 
He questioned, however, hew the scheme proposed in the December 31, 1984, Federal 
Register would deal with live viral or bacterial vaccines produced by recombinant 
DNA technology. He said a great number of these types of vaccines will soon 
be available for administration to large populations. Will the administration 
of these live, sometimes replicating agents to large numbers of people constitute 
release into the environment? He thought many of the problems that have arisen 
with proposed field testing of engineered microbes will arise with administration 
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