Dr. William J. Gartland, Jr. 
September 14, 1983 
Page 5 
Attachment II - Page 5 
"Large scale experiments (e.g., more than 10 liters culture) 
require prior IBC review and approval (See Section III — B— 5 - ) . Since 
these host-vector systems are exempt from the guidelines at the 
laboratory level and have been shown not to represent a significant 
risk to health or the environment, some latitude in the application 
of the Pl-LS containment requirements as outlined in Appendix K-II-A 
to F is permitted. For example, at the discretion of the IBC, 
certain large scale transfer and processing operations may be carried 
out beyond the fermentaton state with viable recombinant organisms 
provided operator exposure and environmental losses are minimized." 
Sincerely yours. 
Max M. Marsh 
Research Advisor 
Secretary, Lilly Institutional 
Biosafety Committee 
References attached: (1) GMAG Note 14, September 1982 
(2) S.L. Gorbach, J. Infectious Diseases 
137, 615-23 (1978) 
cc: Ms. I. M. Brandt 
Dr. I. S. Johnson 
Dr. G. J. McGarrity 
Dr. R. W. McKinney 
Dr. W. L. Muth 
Dr. B. Talbot 
[ 357 ] 
