2 
Section I-D-6 prcrfiibits scale up of recombinant DNA experiments above ten 
liters of culture. D:. Jbhnson's proposal would remove large-scale 
procedures involving ^ ooli EKl, cerevisiae laboratory strains and HVl 
B. subtilis host-vector systems from the requirement for prior PAC review 
and approval; rather the Institutional Biosafety Committee (IBC) of each 
institution would review and approve large-scale proposals involving these 
host-vector systems. Dr. Bems said that RAC review of large-scale experi- 
ments would be substantially reduced if this proposed modification in the 
Guidelines is accepted by the RAC and approved by the Director, NIH. 
Dc, Bems said that in the past, the majority of large-scale prc^sals reviewed 
by the RAC have been "voluntary submittals" from industrial firms. Hiese 
reviews supported the development of large-scale methods during a period 
v^en the Federal agencies (e.g., USDA and FDA) having proximate regulatory 
authority have not in 5 >leroented standards or guidelines for the use of recom- 
binant DNA technology. While these agencies send liaison members to the 
RAC, the agencies do not exercise voting privileges; Dr. Bems said he and 
Dr. McKinney felt that this meeting might appropriately provide an opportunity 
for the agencies to discuss from their perspective, the effects of the 
proposed changes to the NIH Guidelines. 
Dr. Mc^^inney asked if any industrial representatives present at the meeting 
might explain their company's views on the NIH voluntary submissicxi program. 
Mr. Silverman, a legal counsel for Stauffer Chemical Company, said his company 
would abide voluntarily by the NIH Guidelines because of legal considerations. 
Industry recognizes that local government has a great interest in this area, 
and dealing adequately on the Federal level would aid in interacting with 
local government. In addition, Stauffer Chemical Company scientists want to 
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