20 
problems will £u:ise when controls are removed." She further stated that "no 
ocnparative studies of the risks of small- and large-scale wotic have been 
carried cut, and any statements comparing these risks are developed against 
a background of very wide uncertainty." She refers to several concerns 
raised in the CEC report. 
Dr. McGarrity said that the CBC report raises concerns but eilso states that 
industrial fermentaticn processes are unlikely to be contaminated because 
fermentation failure is a very expensive problem. Tb be productive, fer- 
menters must operate almost continuously. He said these economic facts 
argue for strong quality control meMures in industry. Dr. McGarrity added 
that the authors of the CEC report were "iupressed by the well documented 
care" taken by the industry "to ensure the wholesomeness of their products." 
Dr. McGarrity said that the CEC report tends to support Dr. Johnson's position 
rather than Dr. Wright's. Dr. McGarrity then seconded Dr. McKinney's motion 
for approval. 
Mr. “Itxjmton then recognized Dr. Wright. She said that the CEC report is the 
only report that has bron written on the haz^u:ds of the industrial uses of 
genetic biotechnology. She said that the CEC report states: (1) that the 
scale of the use of microorganisms is going to expand so greatly that this 
area should be carefully examined, and (2) this work should be regulated. 
She said she %«s not convinced by Dr. McGarrity 's arguments aux3 said the 
RAC has not yet addressed several areas of serious concern. 
Mr. Thornton then recognized Dr. Max Marsh of Eli Lilly and Company. 
Dr. Marsh noted that Dr. Wright's September 2 letter states that Dr. Johnson's 
proposal "would exempt large-scale work involving ^ ooli K-12, Saccharomyces 
oerevisiae , tocillus subtil is , and any other host-vector system listed in 
Append ix”c of the Guidelines." Dr. Marsh pointed out that Dr. Wright is 
incorrect in claiming this would extend to "any other host-vector system." 
Dr. Johnson's proposal was very specific as to the three specified host- 
vector systems which would be covered by this amendment. 
In addition. Dr. Marsh pointed out that a continuous fermentation operation 
is a very complex process which is computer controlled. It is very easy with 
the continuous monitoring utilized to detect contamination. 
Dr. Miller of FDA said that both the consuming public and the biotechnology 
industry would be served by this change in Section I-D-6. 
Dr. Saginor said that since this proposal would delegate responsibility to 
IBCs, he wanted to mention for the record his concern that IBCs be kept in 
place, in relation to agenda item III considered earlier in the meeting. 
[2111 
