Dr. McGarrity said a revised Section III-A-2 had been recommended 
by the RAC at its September 29, 1986, meeting although it still 
had not been acted upon by Dr. Wyngaarden. He noted differences 
between the wording recommended at the September 1986 meeting and 
the proposed language above. He said a multidisciplinary effort 
will be needed to develop Appendices M, N, and 0. 
Dr. McGarrity said in closing that regardless of RAC's action on 
this proposal that he strongly urged “that an immediate effort be 
made to develop standards for the environmental issues 
surrounding vaccines developed by recombinant techniques. - 
Dr. Gottesman said she felt the proposal included changes which 
were significant in setting up a structure for including 
Appendices M, N, and 0. However, even if the proposed changes 
were to be made part of the NIH Guidelines, nothing would change 
in the review of specific applications until the actual text of 
Appendices M, N, and 0 was written. A RAC working group would 
formulate Appendices M, N, and 0, and then put these out for 
public comment. Before becoming part of the NIH Guidelines, the 
RAC would review the proposed text of the appendices. She stated 
that a vote in support of the new proposed Section III-A-2 is 
thus basically a vote in support of a concept with a chance to 
subsequently review the actual text of the appendices. The 
second sentence of the proposed Section III-A-2 is an attempt to 
get more substance into the term "deliberate release" and to 
indicate that it should not have a pejorative connotation. 
Sections b. and c. of the proposed Section III-A-2 are identical 
to recommendations voted on by RAC at the previous meeting and 
under consideration by Dr. Wyngaarden. She said she favored the 
revision of Section III-A-2 of the NIH Guidelines proposed by the 
working group. 
Dr. Korwek asked how this proposed change in Section III-A-2 
found at tab 12 86/11 related to a further change in Section III- 
A-2 found at tab 1286/III. Drs. Gottesman and Talbot pointed out 
that the RAC proposed certain changes in Section III-A-2 at the 
previous RAC meeting. Tab 1286/11 proposes certain additional 
changes, and RAC should consider this first. Tab 1286/III 
proposes further changes, and this will subsequently be 
con sider ed . 
Dr. Sharpies reminded the RAC she had voiced considerable 
objection to the changes in Section III-A-2 recommended by the 
RAC at its September 29, 1986, meeting and clarified that her 
ranarks today were not to be taken as referring to those changes; 
she had not changed her mind regarding her obj ections to those 
changes. In regard to the further changes proposed in tab 
1286/11, she stated she had no objection to the incorporation of 
the term "planned introduction" to describe or amplify what 
constitutes a "deliberate release." However she said that she 
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