3 
Dr. Robert McKinney, Chair, called the meeting of the Large-Scale Review Working 
Group to order at 9:15 a.m., February 7, 1984. Dr. McKinney introduced the ad 
hoc consultant, Ms. Debra Hunt of the University of North Carolina to the 
workinq group. Dr. McKinney then recounted the history of the proposal which 
the RAC had remanded to the working group for consideration. 
Dr. McKinney said Dr. Irving S. Johnson of Lilly Research Laboratories, a 
division of Eli Lilly and Company, proposed that procedures be modified for 
experiments involving more than 10 liters of culture of "exempt" organisms, 
i.e., those listed in Appendix C of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules. Specifically, Dr. Johnson proposed the following 
two changes in the Guidelines: 
1. Delete statements in all sections of Appendix C that refer to large-scale 
experiments, viz: "Large-scale experiments (e.g., more than 10 liters of 
culture) require prior IBC review and approval. (See Section III-B-5)." 
2. Modify Section III-B-5 to read as follows: 
"III-B-5. Experiments With Non-Exenpt Organisms Involving More Than 10 
Liters of Culture. The appropriate containment will be decided by the 
IBC. Where appropriate, the large-scale containment recommendations of 
the NIH should be used (See Appendix K)." 
Dr. McKinney said this proposal was reviewed by the RAC at its September 19, 
1983, meeting. During the 30 day comment period (prior to the meeting) one 
comment was received from a RAC member; this comment was discussed by the RAC at 
the September 19 meeting. The comment encouraged the RAC to reject the proposal 
and to retain the current provisions of the Guidelines for the following reasons: 
"The current Guidelines provide adequate guidance for establishing 
containment levels and reflect practices appropriate to these levels. 
They provide institutions and the NIH the necessary degree of over- 
sight for activities involving large-scale research or production with 
organisms containing recombinant DNA. This oversight is viewed as 
essential for activities in which the NIH is a participant. In addi- 
tion, the experiments exempted under Appendix C of the Guidelines are 
recommended to be conducted under PI physical containment conditions. 
This equates with Pl-LS for research or production quantities in excess 
of 10 liters." 
The RAC generally supported this position. 
In response to this letter. Dr. Max Marsh of Eli Lilly and Company offered an 
alternative revision of the Guidelines (Attachment II) and suggested to the 
RAC that the issue be remanded to the Large-Scale Review Working Group for 
review. He specified two areas of large-scale cperations that Eli Lilly and 
Company wished to see reviewed : (1) the types of filters used in the air exhaust 
system, and (2) handling of large-scale cperations outside of the fermenters. 
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