p. 6 — VII-B-3-b. The requirement for a "curb or similar architectural 
feature" does not recognize the construction and features of large 
scale fermenters. Based on our many years of experience, we feel 
that the possible rupture of stainless steel fermentation vessels 
is so remote as to warrant its exclusion from consideration. 
We do not feel that the P3-LS level of containment is a realistic 
entity as discussed before. We feel a much, safer approach, is to 
require sufficient characterization studies of the recombinant DNA 
organism to allow its derating to P2-LS or Pl-LS. 
Sincerely, 
James D. Punch, Ph.D. 
John H. Coats, Ph.D. 
Co-chairman, Upjohn Recombinant 
DNA Advisory Committee 
/dsc 
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