Dr. McKinney noted that Section III-B-5 of the NIH Guidelines 
inposes upon the IBCs the obligation to establish the containment 
level for large-scale experiments. Dr. Gottesman underlined the 
fact that the proposal would not change the requirement for IBC 
review. She suggested not accepting the first sentence of Dr. 
Young's proposal, i.e. , keeping the text as is for laboratory- 
scale experiments. For the large-scale experiments, she 
suggested accepting Dr. Young's proposal, but with the addition 
of the word "generally", i.e., "....conditions generally need be 
no greater..." She said the word "generally" would involve 
overall advice to the IBCs, but they could raise containment in 
specific cases if they believed it was indicated. Mr. Mitchell 
asked Dr. Gottesman if she meant this wording to apply to all 
three sections being discussed. She replied that she did. 
Dr. Gottesman then moved that the RAC not accept the first 
sentence proposed by Dr. Young but accept the second sentence, 
modified to read: 
"For large-scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions generally need be no 
greater than those for the host organism 
unmodified by recombinant DNA techniques." 
Dr. Qpstein seconded the motion, and Drs. Walters and McKinney 
said they supported it. 
Dr. Vidaver suggested that the clause "provided that the new 
product is neither toxic nor allergenic to humans, " might be 
added to the end of the sentence. Dr. Gottesman stated that if 
such cloning produced molecules which were highly toxic for 
vertebrates they would be covered under Section III-A-1 of the 
NIH Guidelines. 
Dr. Cohen said that perhaps one could say: 
"Ihe appropriate physical conditions are 
those consistent with good manufacturing 
processes as used for the host organism 
without recombinant DNA. " 
Dr. John Keene f ran Abbott Laboratories said that the RAC should 
be dealing with the safety associated with recombinant DNA, not 
the product. In industry, one looks at the safety of personnel 
and protecting them from any untoward effects regardless of the 
use of recombinant organisms. 
Mr. Mitchell then asked Dr. Gottesman to state the current motion 
as amended for purpose of a vote. She stated the proposal is to 
change that paragraph in Appendices C-II, C-III, and C-IV which 
currently begins, "For large-scale..." to now read: 
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