Dr. Cohen said he had no major objection to the request, but he 
was slightly concerned because it implies that interpretation is 
left to the principal investigator and that perhaps continued use 
of exchanger lists or definitions of what organisms are covered 
under such amendments may be preferable. 
Dr. McKinney said he was troubled by the lack of definition of 
such terms as "extended history" and "safe industrial use." He 
said "extended history" could be interpreted to mean almost any 
time frame, and that due to lack of recorded fermentation 
accidents and lack of monitoring, there was no way to judge what 
"safe industrial use" was. He said it was important that risk 
assessments be done so that such terms could be eliminated and 
experiments could be judged on the facts at hand, not history 
which may or may not be available for a given material. 
Dr. Pramer said he was not uncomfortable with this broad proposal 
based on the proposals being received from industry, particularly 
if the one from Eli Lilly to be discussed next is taken as an 
example. He said with the past experience with Saccharomyces and 
E. coli , he was willing to accept such a proposal, especially 
since it was still subject to the system of checks and balances 
built into the NIH Guidelines, i.e., IBC review and 
recommendations . 
Dr. Riley said the terms "non-pathogenic" and "non-toxicogenic" 
were generic and needed more definition, and she believed a case- 
by-case review was still necessary until a group could establish 
universally acceptable definitions of organisms that could be 
exempted. 
Dr. Johnson said, in reference to Dr. McKinney’s comments, that 
people had been looking for adverse reactions in large-scale 
fermentation and the only one was allergenicity to products such 
as penicillin, but that workers were avidly monitored. 
Furthermore, if a general approval of organisms widely used in 
large-scale fermentation is not made available, the RAC could 
expect a long list of single case proposals in the coming years 
which could hinder U.S. competitiveness in the field. 
Dr. Gottesman questioned whether the flexibility is already there 
and this just allows for the recognition of the flexibility and 
the problem of specifying containment could be left to the local 
IBCs on a case-by-case basis. 
Dr. McGarrity said he believed local IBCs could recommend lower 
than BL1-LS. Dr. Gartland said the next sentence of the current 
Section III-B-5 recommends following Appendix K, where 
appropriate, and "where appropriate" is the language which 
provides flexibility for the IBC. However, he said, IBCs are 
reluctant to use this. 
Recombinant DNA Research, Volume 13 
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