c 
Lilly Research Laboratories 
A Division of Eli Lilly and Company 
307 East McCarty Street 
Indianapolis. Indiana 46285 
Irving S Johnson. Ph D. 
Vice President 
April 18, 1983 
Dr. Richard M. Krause, Director 
National Institute of Allergy and 
Infectious Diseases 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Krause: 
At its meeting on April 11, the Recombinant DNA Advisory Committee 
voted to recommend that the large-scale recommendations for research 
and production using recombinant organisms be incorporated into the 
NIH Guidelines. Aside from this abrupt departure from established 
NIH policy not to regulate recombinant DNA or other production 
operations, and notwithstanding the obvious fact that the major 
functionaries in this area would not be NIH grantees, there are some 
internal discrepancies which this proposed change would acerbate. 
We are concerned, in general, about those experiments that are now 
considered exempt under the laboratory guidelines. A situation could 
be created in which organisms considered safe enough to be exempt 
under laboratory guidelines would not be exempt under large-scale 
guidelines. It has been shown repeatedly that an increase in volume 
of fermentation of a safe organism does not result in production of 
an unsafe organism. 
For the above reasons, we respectfully request your serious 
evaluation of the RAC proposal with the hope that you will agree 
with us regarding its inadvisability. 
Sincerely yours 
ISJ/rl 
cc: Dr. W. J. Gartland, Jr. 
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