10 
Pr. Tblin suggested that. Appendix C be modified: Appendix C currently applies 
to laboratory experiments. She suggested the second paragraph of Appendix C— II, 
C-III and C-IV might read: 
"For these exempt experiments, PI physical containment conditions are 
rec amended ; for large-scale experiments, Pl-LS is recommended. 
Dr. Levin felt the Eli Lilly proposal was vague and that if any language is 
modified, the working group should specify the minimum amount of data the IBC 
would review. Dr. Miller said the organisms listed in Appendix C are benign, 
and the procedures employing them are subject to the regulatory reviews of 
agencies such as OSIA, FDA, etc. 
Dr. Levin suggested that the data submitted to the IBC should be equivalent to 
the data presented to the working group. Dr. Miller disagreed; he thought the 
conditions would vary fran case to case. Dr. McKinney felt the duties and 
oblioations of the IBCs are defined in the Guidelines. 
Dr. Tolin refined her preposed language to read: 
"For these exempt experiments in the laboratory, PI physical containment 
conditions are recommended . For large-scale fermentation experiments 
with exempt organisms, Pl-LS physical containment conditions are recom- 
mended . However, following review by the IBC of appropriate survival 
data for the particular host-vector systems, certain alternatives may be 
recommended . " 
Dr. Miller suggested that the phrase "by the IBC" be deleted from the pro- 
posed language. Dr. McKinney asked if the proposal should limit the type of 
data reviewed to "survival" data. Dr. Miller suggested that if the modifier 
"survival" is used before "data" the phrase should read "survival and other 
data." He felt data characterizing the organism were also important. 
Dr. folin agreed. 
Dr. McGarrity felt any preposed modifications should be introduced into Sections 
Appendix K-II-B and K-II-D rather than into Appendix C. 
Dr. Tolin moved that the following new paragraph be added to Appendix C-II, 
C-III, and C-IV: 
"For large-scale fermentation experiments, Pl-LS physical containment 
conditions are recommended. However, following a review by the IBC of 
appropriate data for the host- vector system, seme latitude in the appli- 
cation of Pl-LS requirements outlined in Appendix K-II-A through K-II-F 
is permitted, provided operator exposure and environmental losses are 
minimized . " 
Dr. Muth asked if a reference to this language should be included in Appendix K. 
Dr . McKinney suggested that a reference be added to the end of Appendix K-I . 
Dr. Tolin suggested the following sentence be added to the end of Appendix K-I: 
[346] 
