Recombinant DNA Advisory Committee - 10/16/90 
table." He said this would at least make the reader cognizant of 
the fact that other regulations and guidelines may apply and 
still be applicable. 
Dr. Atlas questioned whether this was necessary since the NIH 
Guidelines are limited to experiments funded by the NIH and that 
other Federal, state, local, and regulations can be applied 
independently. He said this type of footnote could be put on the 
entire NIH Guidelines , He suggested perhaps the same intent 
could be easier dealt with by changing the title of the table to 
"Summary of Containment Levels Under the NIH Guidelines He 
noted that in this way, if the table were to be used as a 
separate table, independent of the rest of the document this 
would clarify where it came from and to what it refers. 
Dr. Clewell said that he agreed in general with the setting up of 
this category of "Good Large-Scale Practice" and the proposal as 
modified by the subcommittee. 
Dr. McGarrity asked for clarification as to whether the footnotes 
would remain in the Appendix. Dr. Riley said this was one of the 
things the subcommittee felt ORDA needed to look at. She said it 
was anticipated that Footnote 2 would be deleted, but she left 
that decision up to ORDA. The staff would be responsible for 
ensuring that the grid and any prose associated with the grid 
would conform with the existing guidelines for BL1-BL3. In 
addition, the description in the table for the GLSP level should 
reflect what is found in the prose passages of Appendix K-II. 
Dr. Post said that he was concerned that the text that appears in 
The Federal Register draft is not as complete as the text that 
appears in the existing Appendix K-II, and stressed the necessity 
for ORDA to ensure that the prose in the table is transcribed 
properly from Appendix K-II. He suggested perhaps it would be 
better for ORDA complete their review before further review by 
the committee. Dr. Riley said this may provide for a more 
expeditious review. 
Dr. Henry I. Miller of the Food and Drug Administration (FDA) 
agreed with Dr. Post in his assessment of the notice in The 
Federal Register, He added that FDA had submitted written 
comments which included minor suggestions, but overall he felt 
the wording in the notice reflected the contents of the NIH 
Guidelines and was appropriate to the standard levels of 
practice. 
Dr. Riley noted that there were suggestions which were made both 
in the FDA letter as well as one from Dr. Silverman of the 
University of California at Los Angeles as to suggested changes 
in Appendix K-II. She asked Dr. Miller if he would like to 
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