Dr. Foglesong said Lilly was asking for RAC approval but that the 
IBC was maintaining the option to require a containment level 
higher than that approved by the RAC, and that approval was being 
sought for both experimental and production methodology. 
Dr. McKinney suggested that the IBC should compare their good 
industrial practices at least against BL1-LS so judgments can be 
made as to what exactly will be done. The focus should not be 
limited to infectivity or pathogenicity of the organism being 
fermented and environmental concerns should be taken into 
account. He said Dr. Johnson had already alluded to concern over 
the issue of antigenicity of the culture. 
Dr. McKinney noted the proposal stated, "It is intended that the 
effluents from the process, including the biomass will be 
inactivated prior to removal from the facility." Lilly believes 
the strain to be safe insofar as any viable cells of this 
organism which would reach the environment would be at low 
concentration and not hazardous to man or the environment. 
Dr . McKinney said he wanted to know if in fact it was intended 
that the biomass and the waste from the process would be 
discharged into the environment, and if so, how this would be 
done. However, he stressed he was in basic agreement with the 
process and the intended method of operation. 
Dr. McGarrity said Dr. Pramer and he had discussed this proposal 
and that Dr. Pramer had implied he viewed this proposal 
favorably. Dr. Miller said the FDA was essentially in agreement 
that the organism is wholely appropriate to be grown at a lower 
containment level and the recombinant DNA modification was not 
significant to raise the level of containment. 
Dr. McKinney reiterated his concern about potential environmental 
impact because he felt there was a lack of data addressing 
introduction of this organism into the environment. 
Dr. McGarrity asked if this same concern would hold true on the 
discussion of the revision of Appendix K-l where the IBCs were 
allowed, where appropriate, to lower containment from BL1-LS. 
Dr. McKinney replied this would apply, however the institution 
would then assume the responsibility, rather than NIH supplying 
approval . 
Dr. Fordham from Novo Scientific said all such products would 
undergo an environmental assessment before approval by other 
agencies such as EPA or FDA. 
Dr. Foglesong said with more than ten years' experience with 
recombinant DNA technology and several decades experience in 
fermentation technology it is the belief of Lilly that the LU-4 
strain constructed by Lilly, like its non-recombinant 
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