9 
said there may be potential for confusion in the Guidelines because 
Appendix A and Appendix C both list organisms "exempt" from the Guidelines. 
To address this concern Dr. McKinney suggested the word "exemptions" in 
Appendix A be replaced with the word "exclusions." Mr. Mitchell suggested 
such a modification in the Guidelines as well as that proposed in tab 
1171 would have to be published in the Federal Register for 30 days of 
public cament. Dr. McKinney agreed this issue would be better discussed 
at a future RAC meeting. 
Dr. McKinney moved adoption of the proposal to amend Appendix G. 
Dr. McGarrity seconded the motion. By a vote of twenty in favor, none 
opposed, and no abstentions, the motion was carried. 
IV. AMENDMENT OF PROCEDURES FOR SCALE-UP OF ORGANISMS LISTED IN APPENDIX C 
Dr. McKinney introduced the proposal (tab 1156/1, 1154, 1163, 1173, 1174) 
to modify procedures for large-scale operations involving organisms 
listed in Appendix C. He said the proposed amendment has a lengthy and 
complicated history. 
In May 1983, Dr. Irving S. Johnson of Eli Lilly and Company proposed that 
procedures be modified for experiments involving more than 10 liters of 
culture of "exempt" organisms listed in Appendix C of the NIH Guidelines 
for Research Involving Recombinant DNA Molecules. In September 1983, 
Dr. Max Marsh of Lilly Research Laboratories offered an alternate modifica- 
tion of Appendix C and requested it be referred to the RAC Large-Scale 
Review Working Group. The proposals were reviewed by the RAC at its 
September 19, 1983, meeting and referred to the Large-Scale Review Working 
Group. The Large-Scale Review Working Group met on February 7, 1984. 
After evaluating data and discussing the issues, the Large-Scale Review 
Working Group proposed the following modifications to the Guidelines: 
(1) In Appendix K-II-D of Appendix K-II, Pl-LS Level , the word 
"minimize" would be substituted for "prevent." Appendix K-II-D 
would read as follows: 
"Appendix K-II-D. Exhaust gases removed from a closed system or 
(Other primary containment shall be treated by filters which have 
efficiencies equivalent to HEPA filters or by other equivalent 
procedures (e.g., incineration) to minimize the release of viable 
organisms containing recombinant DNA molecules to the environment." 
(2) The second paragraph of Appendix C-II, Experiments Involving E. coli 
K-12 Host-Vector Systems ? Appendix C-III, Experiments Involving 
Saccharcmyces cerevisiae Host-Vector Systems ; and Appendix C-IV, 
Experiments Involving Bacillus subtilis Host-Vector Systems ; would 
be modified to read as follows: 
"For these exempt laboratory experiments, PI physical containment 
conditions are recommended." 
[ 462 ] 
