5 
I. CALL TO ORDER AND OPENING REMARKS 
Mr. Robert Mitchell, Acting Chair, called the meeting to order at 9:00 a.m., 
on September 19, 1983. He asked whether a quorum was present and was 
informed by Dr. Gartland that there was a quorum. Mr. Mitchell then intro- 
duced two new RAC members: Dr. Mark Mills of Good Samaritan Hospital in 
Vincennes, Indiana, and Dr. Wolfgang Joklik of Duke University Medical 
Center in Durham, North Carolina. Mr. Mitchell then introduced the two ad 
hoc consultants for the September 19 meeting of the RAC: Dr. Anne Vidaver 
of the University of Nebraska in Lincoln, Nebraska, and Dr. LeRoy Walters 
of Georgetown University in Washington, D.C. 
II. MINUTES OF THE APRIL 11, 1983, MEETING 
Mr. Mitchell called upon Dr. McGonigle to review the minutes (tab 1119) of 
the April 11, 1983, meeting. Dr. McGonigle said he believed the minutes 
were substantively correct and moved approval. Dr. Harvin seconded the 
motion. Mr. Mitchell then called for a voice vote, and the minutes were 
unanimously approved. 
II. PROPOSED AMENDMENT OF PROCEDURES FOR SCALE-UP OF EXEMPT ORGANISMS 
Dr. McGarrity began review of the proposal (tabs 1114, 1117/11, 1121, 
1124) of Dr. Irving S. Johnson of Lilly Research Laboratories, a division 
of Eli Lilly and Company. Dr. Johnson had proposed that procedures be 
modified for experiments involving more than 10 liters of culture of organ- 
isms listed in Appendix C of the Guidelines. Specifically, Dr. Johnson 
preposed 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-Exempt Organisms Involving 
More Than 10 Liters of Culture. The appropriate contain- 
ment will be decided by the IBC. Where appropriate, 
Appendix K, Physical Containment for Large-Scale Uses of 
Organisms Containing Recombinant DNA Molecules , should be 
used." 
Dr. Johnson's letter expressed concern "over the discrepancies between 
laboratory scale and production scale containment requirements - particularly 
for organisms in the categories that are 'exempt' under laboratory conditions. 
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