Dr. McKinney said this was the underlying issue, the reluctance 
on the part of a number of IBCs to take on the responsibility for 
determining what containment levels will be used. He agreed with 
Dr. Gottesman that the proposed recommendation does nothing that 
the current III-B-5 does not already do. He said a narrative 
could be added to describe good industrial practices but these 
vary according to the process involved and the group performing 
the fermentation. 
Dr. Gartland said he had spent time with representatives from Eli 
Lilly discussing the way the NIH Guidelines are currently 
constructed. In essence, if a small-scale experiment requires 
BL1, then the same experiment done on a large-scale basis would 
require BL1-LS, but the wording "where appropriate" added a 
certain amount of flexibility. 
Dr. Miller said the FDA had proposed over a year and a half ago 
that going to large-scale with exempt organisms such as E. coli , 
B. subtilis , or Saccharomyces required only very low containment, 
and that BL1-LS was unwieldy, expensive and unnecessary for 
academia and for industry. Experience since then has shown that 
utilization of lower than BL1-LS containment for these organisms 
had produced no demonstrable problems and had met with a great 
deal of acceptance and enthusiasm from industry. He said FDA 
urged that some generic criteria be adopted for exactly the same 
reasons, because many of these organisms require only very low 
containment, that BL1-LS is unwieldy, expensive and unnecessary, 
and that this will allow industry to plan for future production 
facilities which will need to be built as the industry expands. 
Dr. Miller said the FDA would prefer criteria closer to the OECD 
proposed generic criteria mainly because these have been adopted 
and accepted throughout the world. 
Dr. Cohen suggested expanding the list of exempt organisms. Dr. 
McKinney suggested deleting the second sentence of the current 
III-B-5 and substituting the statement, "Where appropriate. 
Appendix K shall be used," and allow the IBCs to decide 
appropriate containment on the basis of such data as they deem 
necessary to make their decisions. Dr. Gottesman said she 
believed there could be changes made to Appendix K to add 
flexibility. 
Dr. McKinney said he agreed with Dr. Riley that the NIH 
Guidelines were developed with the greatest concern being 
addressed to risk to humans performing recombinant DNA research. 
This concern has now shifted, as the technology has grown, from 
the laboratory to the environment outside the laboratory and the 
impact of recombinant DNA on the total world. He stressed more 
attention needed to be paid to the total environment but that any 
language needed to be flexible enough to move at the pace of the 
technology. 
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Recombinant DNA Research, Volume 13 
