8 
DiscussiCTi of Prcrfiibition I-D-6 
Dr. Iblin suggested the group discuss in greater detail the proposal to 
eliminate the prohibition concerning scale-up beyoid the 10 liter limit. 
Dr. Bems said the 10 liter limit was instituted with laboratory scale 
procedures in mind. Mr. Barbeito of the NIH Division of Safety said that 10 
liters is the volume which can be totally contained in most standard labora- 
tory procedures, and for this reason was selected as the upper limit for 
small-scale procedures. In the industrial setting, however, concerns such 
as protection of product purity and financial considerations force companies 
to employ vigorous procedures to guard against contamination. Thus, large- 
scale procedures in an industrial setting might logically be viewed in a 
different light from laboratory procedures. 
Dr. McKinney pointed out that industry complies voluntarily with the 10 
liter limit. The 10 liter limit is mandatory only for laboratories supported 
by Federal funding. Dr. Levin pointed out that those cotpanies purchasing 
licensing rights under the Cohen-Boyer patent held by Stanford Uhiversity 
and the University of California would also ccxiply. Mr. Silverman said industry 
will act as if the Guidelines are regulations no matter v*iat their status; 
no company wishes to run the risk of Being found negligent. 
Dr. McKinney asked if industry would continue to submit large-scale prcposals 
to the NIH for review if the 10 liter limit were abolished. Dr. Marsh said 
Eli Lilly and Company would submit information, as industry regards RAC as a 
forum for discussion. Dr. McKinney asked Dr. Marsh if Eli Lilly would notify 
NIH of all recombinant ENA procedures, including those procedures using host- 
vector systems exempt from the Guidelines. Dr. Marsh replied that Eli Lilly 
and Company reporting procedures would comply with NIH Guideline requirements. 
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