“For large-scale (LS) f ermentation 
experiments, the IBC shall review physical 
containment conditions. Generally conditions 
need be no greater than those for the host 
organism unmodified by recombinant DNA 
techniques. IBC review should include 
consideration of the description of BL1-LS in 
Appendix K-II." 
Dr. Johnson stated that since Dr. Young was a previous member of 
the RAC and is knowledgeable in the molecular biology of B. 
subtil is , that the RAC should take his suggestions seriously. He 
then stated he took issue with Dr. McKinney's statement that 
there was no requirement for manufacturers to obey the NIH 
Guidelines in light of the fact that industry has indicated it 
will obey the NIH Guidelines voluntarily and that regulatory 
agencies insist upon it. 
Dr. Johnson said that in the vast experience with E. coli , B. 
subtil is , and S_. cerevisiae there have been no health associated 
risks involving large-scale production with these organisms 
except for occasional hypersensitivity to secondary metabolites 
in the fermentation process. 
Dr. Johnson said that while he generally supported the thrust of 
the proposal, since the proposal came from an agency which 
regulates the company which anploys him, he felt there could be 
an apparent conflict of interest and that he would like the 
public record to show that he would be abstaining from any vote 
on the proposal. 
Dr. Sharpies asked if the wording proposed by Dr. Young applied 
only to S^. cerevisiae , B. subtil is , and E. coli , to which Dr. 
Talbot replied that that was the case. Dr. William Szkrybalo of 
the Pharmaceutical Manufacturers Association stated that his 
organization felt the proposed revisions were highly important 
clarifications of the NIH Guidelines. They will provide 
“appropriate consistency of policy and practice throughout the 
research process." He said that at present IBCs are reluctant to 
use the "seme latitude" provision. He cited the industry's long 
and distinguished record in fermentation techniques. His 
organization supports Dr. Young's proposal and believes it will 
enhance the strategic planning process at member companies and 
the competitive position of U.S. biotechnology and pharmaceutical 
industries. 
Dr. Miller said he would not have a strong obj ection to 
maintaining the original language where it describes containment 
at laboratory-scale, but that the important change is for large- 
scale and the proposed change for laboratory-scale was added for 
consis tency . 
Recombinant DNA Research, Volume 1 1 
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