Recombinant DMA Advisory Committee - 
information supplied, the protocol could be brought back before the RAC at its next 
meeting. 
Dr. Lotze would do his best to supply the required information and to bring the protocol 
back before the RAC. 
Dr. McGarrity then noted that because of scheduling conflicts, he would reverse the 
order of presentation of the next two agenda items. He called on Dr. Riley to present 
what was originally noted on the agenda as Item IX. 
VIII. REVISION OF APPENDIX K OF THE "NIH GUIDELINES" REGARDING 
ESTABLISHMENT OF GUIDELINES FOR LEVEL OF CONTAINMENT 
APPROPRIATE TO GOOD LARGE SCALE PRACTICES (GLSP): 
Dr. Riley noted that at the last full RAC meeting, the Subcommittee on Large Scale 
Practices was asked to reconvene to discuss several matters. The revision of Appendix K 
was the result of letters from the Industrial Biotechnology Association and the 
Pharmaceutical Manufacturers Association requesting guidance for large scale practices 
for organisms requiring lower levels of containment than called for in Biosafety Levels 1, 
2, and 3, currently embodied in Appendix K. 
Dr. Riley said the subcommittee agreed that such a lower level would be useful and 
should be called "Good Large Scale Practices" (GLSP), analogous to the term "Good 
Large Scale Industrial Practices" for handling volumes of 10 liters or higher of organisms 
considered to be safe and not having an increased hazard due to carrying recombinant 
DNA molecules. 
Dr. Riley said that tab 1412 contained the proposed revisions to Appendix K, beginning 
on page 5. She noted that during the course of the subcommittee's work a grid was 
developed by ORDA staff which incorporated all levels of containment from GLSP 
through BL3-LS for cross-reference to Appendices K and G. 
Dr. Riley suggested that the discussion be divided into two issues, one concerning the 
new lower GLSP level and the other a discussion of the grid. She noted that there were 
some specific recommendations from the subcommittee that call for higher containment 
in some cases. She added that correspondence had been received and dealt with the 
reactions of companies and associations to changes that affect the higher containment 
levels. Dr. Riley called for comments from other members of the subcommittee prior to 
a full committee discussion. 
Dr. Hirano said she wished to discuss the grid first. She said that it nicely summarized 
the differences between GLSP and BLl-LS, BL2-LS, and BL3-LS, but in doing so it had 
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