Dr. Sharpies agreed to incorporate into her motion the concept that the new working group recommendations would be 
published in the Federal Register if the meetings were held in time and the recomendations were clear enough. 
Dr. Davis requested that the working group consider replacing "deliberate release" with the phrase "deliberate 
introduction" because of the problem of definition of the word "planned." 
Mr. Mitchell took a vote on Dr. Sharpies' motion to recommit the recommendations back to the working group for 
further discussion and clarification and to have their new recommendations published in the Federal Register , if 
possible, prior to the next RAC meeting. 
The motion was passed unanimously with a vote of twenty in favor, none opposed, and no abstentions. 
Dr. Sharpies requested that the Working Group on Definitions be expanded to include additional RAC members who had 
participated in the discussion today. It was agreed to do so. 
IV. PROPOSED AMENDMENT OF SECTION III-A-2 
Mr. Mitchell called on Dr. Gottesman to begin review of the proposed amendment of Section ni-A-2 of the NIH 
Guidelines (Tabs 1264, 1269/1. 1281). 
Dr. Gottesman said since she had proposed the amendment, she wished to explain what it docs and why she had 
proposed it. Basically, the proposal would change the current NIH Guidelines concerning some classes of deliberate 
release experiments so that they would no longer come before the RAC in any form but instead be treated the way 
laboratory experiments of this class are currently treated. Currently there arc certain types of laboratory experiments 
which are exempt from review under the NIH Guidelines, as for instance, experiments involving rearrangement of a 
genome, i.e., "self-cloning," and transfer of DNA from one organism to another when those organisms naturally 
exchange genetic information. However, the NIH Guidelines do not exempt these type of experiments where there is 
deliberate release of such recombinant DNA-containing organisms into the environment. 
Dr. Gottesman explained that among the types of deliberate release experiments which would be exempted from review 
by this proposal the first would be "deletion derivatives not otherwise covered" in the NIH Guidelines. 
The second category of deliberate release experiments to be no longer covered under the NIH Guidelines would be 
organisms covered in Section I1I-D-2, i.e., rearrangements within a single non-chromosomal or viral DNA source 
only. She cited the example of an experiment which rearranges the DNA of a plasmid, puts it back into an organism, 
and deliberately releases it into the environment which would no longer be covered by the NIH Guidelines. She noted 
that the amendment would not change coverage under the NIH Guidelines for experiments where rearrangement of the 
chromosome of bacteria or any other organism had taken place but only change coverage under the NIH Guidelines for 
deletions and rearrangements within non-chromosomal DNA sources, i.e., plasmids or viruses. 
Dr. Gottesman explained that her reasons for proposing the amendment are based on her view that the NIH Guidelines 
were only meant to cover "unique organisms." The previous exemption for laboratory experimentation of classes of 
organisms which were prepared using recombinant DNA but which are not really should now be extended to deliberate 
release of such organisms. 
Dr. Gottesman stated that she believed this amendment is a continuation of the effort already begun in Appendix L to 
classify deliberate release of certain organisms which do not require special review by the RAC. She further stated that 
she has also proposed to the Working Group on Definitions a further step in this direction with the preparation of new 
Appendices M and N, parallel to Appendix L. 
Since deletions occur in nature, deletions made in the laboratory will not result in the creation of unique organisms. 
These types of experiments should be exempted from the NIH Guidelines as well as experiments which result in DNA 
rearrangements within a single non-chromosomal or viral source. 
Dr. Gouesman stated it is very important to realize that this proposal does not guarantee that every deletion is without 
effect or that every deletion will not change the behavior of the organism. However, she submitted that since deletions 
are not "new," they should not be considered by the RAC. Further it is not meant to imply that some deletions should 
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