“For large scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions need be no greater 
than those for the host organism unmodified 
by recombinant DNA techniques." 
Dr. McKinney reviewed sane of the written comments that had been 
received on this proposal and noted that some contained 
alternative language to the proposal. Dr. McKinney asked to be 
placed on record as opposing the adoption of the portion of the 
proposed language which refers to laboratory level experiments in 
that BL1 requirements represent nothing more than good laboratory 
practices and are not restrictive. 
As far as the application of BL1-LS in large-scale production of 
exempt organisms. Dr. Young had referred in his letter to 
manufacturers who utilized conditions of at least BL1-LS "to 
ensure compliance with the NIH Guidelines." Dr. McKinney noted 
that these manufacturers were not obligated to comply with the 
NIH Guidelines and that even in complying with the NIH Guidelines 
the recommendation to use BL1-LS is just that, a recommendation. 
In closing. Dr. McKinney stated he felt the proposed amendment by 
Dr. Young dealing with large-scale fermentation did not offer any 
advantage over present language and suggested the RAC reject the 
proposal . 
Dr. McGarrity said he had come to a different conclusion than Dr. 
McKinney. He stated the word ".latitude" could be interpreted 
many different ways. IBCs may interpret it differently, and Dr. 
Young's proposal clarifies this in a more objective manner. 
Further, he felt the fact that this proposal came from the 
Commissioner of FDA does carry some weight in that he is the 
chief regulator in this whole area. 
Dr. Cohen suggested the proposal be split in two. For the first 
part dealing with laboratory experiments, no change, in his view, 
was necessary since BL1 conditions are simply good laboratory 
practice. However, with respect to large-scale, he agreed that 
the wording "sane latitude" is not really helpful to the IBCs. 
He said he would like to see the terminology reworded for large- 
scale production to encourage modifications appropriate to the 
degree of safety required. 
Dr. Gottesman said she agreed on not changing the sentence 
dealing with laboratory experiments. For large-scale 
experiments, she felt it important to maintain IBC oversight on a 
case-by-case basis. But she agreed that to strengthen this 
concept of latitude there should be a rewording of that statement 
and she suggested a statement such as: 
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