Recombinant DNA Advisory Committee - 10/16/90 
comment on the FDA suggestions. 
Dr. Miller said the first suggestion the FDA had made was that 
restricted access should be required for the BL2-LS level. He 
noted that in most cases it would be unlikely that an organism 
which requires BL2 containment would not be in a restricted 
access site at either a university or industrial facility. 
Further, Dr. Miller said, that at level BL3-LS HEPA filtration 
should be required for supplying air to and exhausting air from 
the work area in Criterion 28. He noted that it would also be 
unlikely that this would not be already in place at most 
universities and industrial facilities dealing with organisms 
requiring BL3 containment. 
He added that if the suggestion for HEPA filtration is accepted 
that some rewording is suggested to get away from a design 
standard and move towards a performance standard. He suggested 
the following wording for Criterion 28: 
"Supply and exhaust air should be HEPA-f iltered, 
subjected to thermal oxidation, or otherwise treated, 
to prevent release of viable organisms." 
Dr. Mark Foglesong of Eli Lilly & Company agreed with the 
suggestions presented by Dr. Miller and noted that if these 
changes are made on the table that it will require going back and 
making the appropriate changes in the prose in Appendix K of the 
NIH Guidelines . 
Dr. Riley said that Dr. Silverman of UCLA suggested adding an 
explanatory or philosophical statement on page 37847 of The 
Federal Register notice, under Appendix K-I. The sentence would 
read; 
"The four levels set containment conditions at those 
appropriate for the degree of hazard to health or the 
environment posed by the organism, as judged by 
experience with similar organisms unmodified by 
recombinant DNA techniques and consistent with good 
industrial large-scale practices." 
Dr. Robert Murray seconded Dr. Post's earlier proposal that ORDA 
make their review and put together all the changes into a final 
version before the committee is asked to vote on it because of 
the many changes. 
Dr. Riley recommended that the Appendix K modifications be 
approved with all of the changes recommended and that the 
modified version come back to the subcommittee for a final review 
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Recombinant DNA Research, Volume 14 
