4 
MINUTES OF MEETING - June 5-6 
Dr. Fredrickson announced the appointment of Mr. Ray Thornton as the 
Chairperson of the RAC effective July 1, 1980. Dr. Fredrickson noted 
that Mr. Thornton is President designate of Arkansas State University. 
He wished Mr. Thornton success in both these roles. Dr. Setlow introduced 
Dr. lino of the thiversity of Tokyo, Japan, a liaison representative to 
the RAC. 
II. VOLUNTARY COMPLIANCE 
Dr. Fredrickson addressed the following statement on voluntary compliance 
to the RAC: 
"I am aware that the RAC has engaged in much discussion of the task it 
has accepted to review applications involving proprietary information. 
Usually, these are submitted by private concerns not supported by 
federal funds and in voluntary compliance with the NIH Guidelines. 
Particularly, some members of the RAC have chafed under the need for 
examination and approval of scale-up operations in industry, a result 
of the 10-liter limit in the Guidelines. Certainly, most members 
find the task onerous and not a few still find distasteful the scien- 
tific review of information which is subject to safeguards including 
criminal penalties for violation. Some members of the RAC also are 
of the opinion: 
1. that the task involves judgments about apparatus for physical 
containment which do not rest upon the same experience and train- 
ing useful for decisions about molecular biology and other 
aspects of recombinant technology; or 
2. that when the judgments about physical containment require site 
inspections in industry, such visits belie the insistence of NIH, 
and its Director, that this agency eschews a regulatory role; 
3. and several members believe consideration of any part of an 
application from the private sector, perhaps even any proprietary 
data, should be done only by a regulatory agency, which NIH is not 
I am grateful to all the members of the RAC, whatever their views on 
this subject, for subordinating their feelings to the extent that 
they have continued to carry out these important duties. In so doing, 
they have made it possible for all users of recombinant technology in 
the U.S.A. to do so under two important conditions that obtain in 
nearly all other advanced countries of the world. These are: 
1. the determination of appropriate procedures by a single national 
body, responsible for interpreting and developing uniform national 
guidelines, and 
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