Dr. Gottesman pointed out that there are already procedures in the NIH 
Guidelines for approval by other Federal agencies of experiments falling 
under Section III-A. Presumably these clinical trials would be submitted 
to the Food and Drug Administration under Investigational New Drug (IND) 
procedures. Dr. Korwek pointed out that there could be a problem with 
pre-human testing in animals since an IND is not required at this stage. 
He said this could be addressed in an appendix to the NIH Guidelines. 
Dr. Gottesman then moved that: (1) investigators in the field of vaccine 
development be apprised of the options for exemption from RAC review as 
specified in paragraph two of Section III-A, and (2) that a working group be 
organized to develop criteria and procedures for inclusion in an Appendix 0 
(Vaccines) of Section III-A-2. The motion passed by a vote of 11 in favor, 
none opposed, and no abstentions. It was the sense of the working group 
that Appendix 0 cover vaccines, and that Appendix N ccver microorganisms 
other than vaccines. 
III. Definition of Recombinant DNA. 
In response to a question by Dr. Neiman, Dr. Gartland summarized why the 
working group had been asked to consider the definition of "recombinant 
DNA." Dr. Korwek questioned the reasons for reconsidering this definition. 
Dr. Gottesman said that she is not aware that the definition needs to be 
changed to take into account any specific experiments. Dr. Korwek said 
that since Section III-A-2 of the NIH Guidelines will presumably be revised to 
handle deletion derivatives, he favored not changing the basic definition c£ 
recombinant DNA. 
Dr. Riley said she felt it is important to exclude some things from the 
defintion. She then moved the following amendment of a sentence proposed 
by Dr. Landy for inclusion in Section I-B at the September 5, 1986, working 
group meeting: 
"Genomes which contain only deletions, duplications, transpositions, 
single-base changes, or rearrangements are not considered to be 
recombinant ENA irrespective of the method by vhich they were produced. 
Products of translocations within genomes are considered to be recombinant 
DNA." 
Dr. Riley said that this wording would make a distinction between trans- 
positions and translocations which had not been made earlier. 
Dr. Korwek questioned why these concerns could not be handled as exemptions. 
Dr. Gottesman noted that these types of experiments are already exempt in 
the laboratory. An alternative approach to achieve the same end would be 
to reword "b" and "c" in a revised Section III-A-2. 
Dr. Neiman said that these concepts about deletions, etc., pertain particularly 
to microorganisms, but he did not feel that this revision of the definition 
would be generally accepted by those in the scientific community vho (teal 
with more complex organisms with more stable genomes. 
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