The first meeting of the Large-Scale Review working Group of the Recombinant 
ENA Advisory Committee (RAC) was called to order at 2:05 p.m. Wednesday, 
April 22, 1981. Ct. McKinney, co-chairman of the large-Scade Review Working 
Group, began the meeting by requesting the members of the working group to 
identify thonselves, their affiliations, their backgrouvJ and interests. 
Dr. Bems, co-chairman of the Large-Scale Review working Gtxxip, presented 
his views on the role of the group. He said RAC had instructed the ^ hoc 
working group to evaluate questions dealing with large-scale procedures and 
facilities. He said the working group would function in a oompletely advisory 
capacity. The Large-Scale Review Working Group might also apprc^iately advise 
institutions, individuals and ocmpanies working in the area of recanbinant 
ENA technology on physiced oontaiment standards and procedures. Dr. McKinney 
emphasized that while the function of the ccmmittee was to serve RAC in an 
advisory capacity, he hoped the working group would serve industry by providing 
assistance and guidemxre. 
Er. McKinney suggested that one issue the working group might consider is 
whether and/or how large-scale submissions from institutions receiving NIH 
funds might be handled. Er. McKinney said he expected to see an increase in 
the mirtjer of universities at which scale-up of growth of recombinant organisms 
is permitted and expressed concern that these IBCs might lack expertise in 
fermentation technology. He suggested that the performance of IBCs that over- 
see large-scale procedures might be examined. Mr. Barbeito of the NIH Division 
of Safety supported this view. 
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