techniques; the IBC can specify higher containment if it deems it 
necessary. " 
Dr. Van Houten, the Chairman of the IBC at Schering-Plough 
Corporation said the IBC there felt they had the power to lower 
containment, but they did not feel comfortable with the possible 
associated environmental release. He said IBCs would appreciate 
studies being conducted to reassure IBC members that if such 
decisions to lower containment are made there are sound 
scientific facts upon which to base those decisions. 
Dr. McKinney replied saying establishment of the biosafety levels 
was based on assessment of risk associated with working with the 
recombinant organisms and principally the risk to humans . He 
suggested possibly a "Points to Consider" document should be 
developed for guidance to IBCs in considering whether they should 
lower containment below BL1 . Further, he suggested industry 
could come up with good industrial large-scale practices criteria 
which could be used for IBCs to measure their decisions. 
Dr. Johnson reiterated that if industry were to be forced into 
case-by-case review of large-scale fermentation production, it 
would place the American industry at a distinct economic 
disadvantage, because the rest of the world is operating under 
generic exclusion criteria. Dr. Miller said there were 
requirements for an entirely closed system in use for low-risk, 
well understood and often used industrial organisms. 
Dr. Foglesong from Eli Lilly said another consideration, aside 
from processing in the fermentor, is processing outside. Under 
BL1-LS standards you are required to inactivate the organism 
before removing it from the fermentor. 
Dr. Gottesman restated the amended wording for Appendix K-I as 
follows : 
"The BL1-LS level of physical containment is 
recommended for large-scale research or production of 
viable organisms containing recombinant DNA molecules 
which require BL1 containment at the laboratory scale. 
For large-scale fermentation experiments involving 
non-pathogenic and non-toxicogenic recombinant strains 
of host organisms having an extended history of safe 
industrial use, the IBC may set large-scale containment 
conditions at those appropriate for the host organism 
unmodified by recombinant DNA techniques and consistent 
with good industrial large-scale practices." 
Dr. McGarrity ruled that this wording was substantially different 
from that of the motion on the floor, whereupon Dr. Gellert 
withdrew his motion and Dr. Pramer his second. Mr. Mannix moved 
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Recombinant DNA Research, Volume 13 
