• What things take large/inappropriate amounts of time? 
Our largest amount of time is spent reviewing large scale facility 
designs to ensure inclusion of appropriate containment equipment. To a 
lesser extent, time is expended performing audits of facilities and 
practices. We feel that none of this time is inappropriate since we 
are concerned with assuring the safety of our employees, the 
surrounding community and the environment. 
• In what areas do you disagree with the RAC with regard to containment 
for a particular experiment? 
During his presentation on October 26, Dr. Waitz suggested a change in 
the Guidelines which we would like to reiterate: 
"...in order to provide greater flexibility during scale-up, we 
suggest that the exception to Appendix C-II, C-III and C-IV 
requiring prior IBC review and approval of large scale experiments 
using exempted E, col i K-12, Saccharomyces cerevi si ae and Baci 1 lus 
subti 1 i s Host Vector Systems be changed. An acceptable modi f i cati on 
would require notification of the IBC simultaneously with the 
initiation of experiments where IBC-approved practices and an 
IBC-approved Pl-LS containment facility are used." 
Proposed language changes for the Guidelines can be found in the 
attached copy of Dr. Waitz' presentation. 
Also, Part VII-B-3 of the large scale recommendations mandates that 
aerosol release be prevented during sample collection, material 
addition and culture transfer. The word "prevents" implies an absolute 
condition which at the Pl-LS level is neither realistic nor necessary. 
We suggest that the word "minimizes" be used instead. Such a change is 
consistent with the intent of this section of the recommendations. 
• In what ways are the Guidelines too stringent or too relaxed? 
The containment recommendations have always represented a reasonable 
approach to rDNA research based on known or perceived hazards. As data 
have been accumulated to demonstrate the minimal human risk associated 
with many types of rDNA research, the Guidelines have been relaxed 
accordingly. Thus, we feel that the Guidelines are adequately balanced 
from a containment standpoint. 
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