11 
"For large-scale, e.g. greater than 10 liters of culture, fermentation 
of these host-vector systems, Pl-LS physical containment conditions 
are recanmended. These fermentations require prior IBC review and 
approval. Fo Hewing review by the IBC of appropriate data for the 
particular host-vector system, the IBC may permit more latitude in the 
application of Pl-LS requirements as outlined in Appendix K-II-A 
through K-II-F." 
Dr. Wensink suggested he would offer a motion concerning these proposed 
alterations. Mr. Mitchell asked Dr. Wensink if he would wait until all 
ccmmsnts on the proposal had been heard before offering a motion. 
Dr. McKinney felt the word "experiments" could be applied to large-scale 
systems; he felt this word captured the intent of the Guidelines. 
Dr. Wensink said he was suggesting the word "fermentations" be substituted 
for "experiments" but he could appreciate Dr. McKinney's opinion. 
Dr. Miller of the Food and Drug Administration (FDA) said FDA has a great 
deal of experience with the oversight of large-scale fermentations. He 
said FDA endorses the proposed amendments as they clarify the NIH Guide- 
lines and cure consistent with FDA's goal of establishing flexible standards. 
Dr. McKinney said he would proceed by offering a separate motion on each 
proposed item of the working group proposal. He moved acceptance of item 
one of the proposal. Dr. Wensink seconded the motion. 
By a vote of twenty in favor, none opposed, and no abstentions, the motion 
carried. 
Dr. Wensink moved RAC accept the alternative NIH staff language of item 
four of the proposed amendment. Dr. McKinney seconded the motion. 
By a vote of twenty in favor, none opposed, and no abstentions, the motion 
was carried. 
Dr. Wensink said he would drop his suggestion to eliminate the word 
"experiment" in item three. Instead, he moved acceptance of itans two and 
three with the proviso that the language of the fifth paragraph of Appen- 
dices C-II, C-III, and C-IV be moved to proposed item three. The language 
of Appendices C-II, C-III, and C-IV reads as follows: 
"Large-scale experiments (e.g., more than 10 liters of culture) require 
prior IBC review and approval (See Section III-B-5)." 
Dr. Talbot pointed out that the status of the requirement for IBC review 
of large-scale procedures would be unclear under Dr. Wensink 's proposed 
modification since Dr. Wensink proposes to move this paragraph frem the 
exceptions to exemptions section into the exemptions section. Dr. Talbot 
preferred the language proposed by the Large-Scale Review Working Group. 
Dr. Wensink agreed to drop his proposed modification. He moved acceptance 
[ 464 ] 
