LILLY RESEARCH LABORATORIES 
DIVISION OF ELI LILLY ANO COMPANY 
INDIANAPOLIS, INDIANA 4SIOS 
I t. JOHNSON, Ph.D 
net MttiMNT 
November 30, 1979 
Dr. Donald S. Fredrickson 
Director, National Institutes of Health 
Room 124, Building 1 
National Institutes of Health 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
RE: PROPOSED PART VII - PHYSICAL CONTAINMENT GUIDELINES FDR 
LARGE-SCALE USES OF ORGANISMS CONTAINING RECOMBINANT DNA 
MOLECULES AS NOTED IN 44 FED. REG. 63074 (NOV. 1, 1979) 
We submit herewith the views of Eli Lilly and Company. 
Lilly is engaged in the research, development, and production 
of pharmaceutical products for human and animal health. The 
current research programs at Lilly include the utilization of 
recombinant DNA technology. Lilly was the first industrial firm 
to register, submit, and receive approval for a large-scale 
experiment under existing NIH Guidelines . Consequently, the 
company has an interest in this proposal. 
We have examined the proposed physical Guidelines for large 
scale uses of organisms containing recombinant DNA molecules 
and are pleased to have the opportunity to comment upon their.. 
We believe the Working Group has made a sincere and thought- 
ful attempt to develop such physical Guidelines but feel that 
(1) they reflect extension of small-scale laboratory Guidelines, 
(2) they do not adequately reflect appropriate experience, know- 
ledge of large-scale fermentation procedures and recognition of 
reliability of the equipment used in commercial production, and 
(3) these guidelines are ultimately tied to the scale-up 
approval procedures discussed at the September 6-7, RAC meeting 
and should be reviewed in light of consideration and comments 
relative to those procedures. 
Only two physical containment levels are recognized by the 
Working Group, i.e. , P2-LS and P3-LS. This approach continues 
to perpetuate tfie misconception of increased volume being 
equivalent to increased risk. It has been documented that the 
10L level was arbitrarily/selected in both the U.K. and U.S. 
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