MINUTES OF MEETING - June 5-6 
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2. the regulation of a rapidly evolving science without passage of 
special statutes, avoiding inflexibility often attendant upon such 
legislation. 
These important conditions are among those necessary for maintenance 
of parity among the nations for safe use of this technology and access 
bo its benefits. It is essential that the RAC, whose deliberations 
affect the course of this field of science throughout so much of the 
world, not alter these conditions by precipitous changes in its 
procedures. 
Nevertheless, I am sympathetic to this malaise of the RAC. We must 
try to relieve it — and to move NIH back from what some see as a 
position on the brink of regulatory involvement. In thinking about 
such relief, I note especially the rising interests of OSHA and 
NIOSH in ascertaining any threats to workers inherent in industrial 
scale-ups. FDA and other regulatory agencies have also begun to 
test their reflexes in a similar way. FDA sponsored here this week 
a useful meeting on industrial application of recombination for 
production of biologies. 
It is apprepria te that these agencies begin to consider their 
mandates as industrial use of recombinant techniques grows. CTie of 
the earliest tasks of the Federal Interagency Advisory Committee on 
Recombinant DNA Research (IAC) was an analysis of the authorities of 
the regulatory agencies in this area. The results indicated that no 
single agency has 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 applications — 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. Fur- 
thermore, 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 
DNA activities that facilitate appropriate evolution of guidelines. 
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 
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