Lilly Research Laboratories 
A Division of Eli Lilly and Company 
307 East McCarty Street 
Indianapolis Indiana 46285 
Irving S Johnson. Ph D 
Vice President 
January 17, 1983 
Dr. William J. Gartland, Jr., Director 
Office of Recombinant DNA Activities 
Department of Health and Human Services 
National Institutes of Health 
Beth es da, MD 20205 
Dear Dr. Gartland: 
Your memorandum of a few months ago solicited comments on the 
Revised NIH Guidelines for recombinant DNA research from the 
Institutional Biosafety Committees (IBCs). We have formulated the 
fol lowing reply: 
In general, we do not see any serious problems with the current 
version of the guidelines. Our IBC delegates technical respon- 
sibility for review of experimental protocols to a subcommittee; 
recommendations of that group are then examined by the IBC 
members in an expeditious manner. We find this to be an 
efficient, operational scheme. As public acceptance of the 
results of scientific risk assessment grows, we would encourage 
the transfer of all decision-making authority to the institu- 
tions — since they do, in fact, bear the ultimate responsibility 
for all actions of their laboratories and production operations. 
Containment requirements have not been a problem. Our labora- 
tories have been accustomed to dealing with experiments 
demanding good microbiological techniques for many years; in 
nearly all requirements, the current guidelines are simply 
reinforcing the need to observe good laboratory practice. 
The IBC has scheduled monthly meetings; however, it has not 
been necessary for the group to meet with that much regularity. 
With our established procedures, it is often possible to 
circulate straightforward protocols for review and action by 
mail. The composition of the IBC membership — as established 
according to the guidelines — precludes its functioning as a 
general biosafety committee; its scope is limited to recombinant 
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