Lilly Research Laboratories 
A Division of Eli Lilly and Company 
307 East McCarty Street 
Indianapolis. Indiana 46285 
I S Johnson. Ph D 
Vice President 
November 3, 1980 
Dr. Donald S. Fredrickson 
Director 
Building One, Room 124 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Re: Recombinant DNA Research 
During the Research Advisory Committee meeting of September 
25-26, several actions were taken which should facilitate the 
proper development of recombinant DNA technology. However, one 
recommendation adopted by the committee for your consideration 
is inconsistent with prior actions taken by the RAC and is in 
our view most inappropriate. Specifically, the RAC proposed 
the establishment of a permanent subcommittee of the RAC on 
large-scale practices. The responsibilities of that 
subcommittee are defined as follows: 
A large-scale review subcommittee of the RAC shall be 
established with the responsibility of advising the RAC 
on procedures and facilities designed pertaining to 
large-scale operations and on the performance of local 
IBC's in reviewing physical containment facilities. 
The subcommittee shall invite participation by the NIH 
Biosafety staff, NIOSH, OSHA, CDC, FDA, EPA, and USDA. 
We consider the establishment of a subcommittee along the lines 
proposed to be ill-advised for the following reasons: 
(1) The proposed subcommittee jurisdiction with respect 
to large-scale operations is inconsistent with prior 
RAC actions. The RAC has previously recognized that 
the increased volume involved in so-called "large- 
scale" experiments does not result in increased risks 
at least insofar as the escape of organisms is con- 
cerned. This is inherent in the RAC proposal to 
delete paragraph 2 of section I-D-6 of the Guidelines 
is noted in 45 F.R. 50526 (July 29, 1980). 
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