Gartland 
May 23, 1988 
from Eli Lilly and Novo and arguments made before the NIH-RAC in 
support of the modification of Appendices C-II, C-III and C-IV which 
were published in 52 Federal Register 31848-31850, August 24, 1987. It 
is understandable that IBC's, in the present regulatory and political 
climate, might be hesitant to set containment levels below BL1-LS. The 
clarification of the Guidelines made in 1987 was a good first step in 
giving IBC's the guidance they need to set appropriate containment. 
Accepting the current proposal to modify section III-B-5 would go the 
second needed step to give appropriate advice to IBC's and bring the 
Guidelines into conformity with the OECD Guidelines and current 
regulatory decisions. We urge the NIH-RAC to recommend this change to 
the Director of NIH. 
Genencor thanks the NIH for the opportunity to comment on this issue. 
We hope that these comments are useful to NIH-RAC as they deliberate 
this issue. 
Sincerely, 
Alice J. Caddow 
Director of Regulatory 
and Environmental Affairs 
/AJC 
[ 374 ] 
Recombinant DNA Research, Volume 13 
