Page 3 of Attachment J 
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It is appropriate that these agencies begin to consider their mandates 
as industrial use of recombinant techniques grows. One of the earliest 
tasks of the Federal Interagency Advisory Committee on Recombinant DNA 
Research ClAC) was an analysis of the authorities of the regulatory agencies 
in this area. The results indicated that no single agency had clear authority 
over laboratory research, but there obviously were appropriate roles for such 
agencies in the oversight and regulation of industrial -scale use of recombinant 
methodologies. All the regulatory agencies also have continuously been kept 
fully informed of the activities concerning the NIH Guidelines, through their 
membership on the IAC, and through their liaison membership on the RAC. 
At the same time, it should be stated here with candor that no federal 
regulatory agency presently has anything like the in-house competence to 
perform — for industrial appl ications — all of the present tasks of the RAC. 
Development of such competence will require time and expense, and it would not 
arise suddenly upon the passage of any statute. Furthermore, we are still at 
a stage where the creation of more than one RAC in this country— one for 
industry, one for non-profit research. — would be inefficient and destroy the 
unity of information-sharing and decision-making about the many aspects of 
handling recombinant DMA activities that facilitate appropriate evolution of 
guide! ines . 
It is, however, apparent that in taking any actions appearing to validate 
physical containment on an industrial scale, the NIH also has insufficient 
in-house competence, and, like the RAC, must rely on consultants. In these 
determinations, a regulatory agency like OSRA , or its researcher partner, NIOSH, 
can use consultants as effectively as can NIH, and may have more staff competence. 
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