THE UNIVERSITY OF ROCHESTER 
mWwsk 
SCHOOL OF MEDICINE AND DENTISTRY • SCHOOL OF NURSING 
STRONG MEMORIAL HOSPITAL 
601 ELMWOOD AVENUE 
Frank E. Young, M.D., Ph.D. 
Dean of School of Medicine & Dentistry 
Director of Medical Center 
275-3407 
February 19, 1980 
Elizabeth Milewski, Ph.D. 
Scientist Administrator 
Office of Recombinant DNA Activities 
National Institute of Allergy and 
Infectious Diseases 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Dr. Milewski: 
Thank you very much for your photocopies of comments in response 
to the request for public comment on draft standards for large-scale 
research and production. The comments clearly fall into two categories. 
Category one represents those that are detail analyses of the specific 
language. Here I .believe we need to rely on Emmett Barkley's digest of 
comments and synthesis of conflicting views. Particularly relevant will 
be the comments from Upjohn and Eli Lilly. In this arena the major con- 
cern appears to be with the type of consideration given to the scale-ups 
in relation to research laboratory procedures. As I have reviewed this 
again, I believe that the question of the apron versus a holding tank for 
liquid that is spilled from a fermenter is an important issue and one 
that we must discuss further. The rest of the comments are clearly 
detail and can be harmonized quite readily with the guidelines. 
A second concern relates to the Pl-LS category that was not included 
in our original write-ups. This was an oversight. We should determine 
whether those organisms, in which there is merely self-cloning, fall 
under this guideline at all or are totally exempt. My own feeling would 
be that the exempt experiments should be exempt for scale-up as well with 
the exception that informational MUA's are submitted, that is, the project 
be registered. This would enable Pl-LS-1 to be used for those organisms 
which are exchanges and might require a little more surveillance. 
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