Lilly Research Laboratories 
A Division of Eli Lilly and Company 
307 East McCarty Street 
Indianapolis, Indiana 46285 
Irving S, Johnson. Ph.D 
Vice President 
March 25, 1983 
Dr. William J. Gartland, Jr., Director 
Office of Recombinant DNA Activities 
Department of Health and Human Services 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
We wish to comment on some of the proposed actions to be considered 
by the Recombinant DNA Advisory Committee (RAC) at its meeting on 
April 11, 1983. In particular, we wish to discuss proposal IV. 
[ Fed. Reg. 48, 9437 (1983)]. 
Large scale recombinant DNA operations are employed only after labo- 
ratory studies have provided appropriate process information; such 
experiments are conducted in the laboratory under NIH guidelines. 
The RAC has previously established the policy of not attempting to 
act as a regulatory body for industry - the principal functionary 
using large scale systems. A mechanism for changing the large scale 
recommendations is already in place. We do not see a particular 
need to incorporate these into the NIH guidelines. Other agencies 
already have the authority to deal with manufacturing practices and 
have undertaken evaluations of recombinant DNA procedures. Both EPA 
and NIOSH have had studies and surveys under way for some time. We 
are confident that those evaluations will confirm the fact that large 
scale fermentation of recombinant organisms, wel 1-characteri zed as 
being safe in laboratory studies, is simply an extension of existing 
antibiotic fermentation technology. 
Sincerely yours, 
'ving $. Johnson 
cc: Dr. Harvey S. Price 
IBA Member Companies 
Dr. William L. Muth 
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