Recombinant DMA Advisory Committee - 5/30-31/91 
made a decision that the RAC not look at the issue of transgenic animals and that it is not 
a mandate of the committee. 
Dr. Atlas asked that if the committee voted to approve the proposal to remove these sections 
from the NIH Guidelines that an advisory be sent to local review boards to tell them that the 
RAC is not getting out the business totally and that they need to continue to review these 
proposals at the local level. 
Dr. McGarrity said he assumed if this proposal were passed that all of the work on the 
appendices currently approved by the RAC but not yet promulgated formally would be turned 
over to the USDA and that they would no longer need be added to the NIH Guidelines.^ Dr. 
Tolin said she would see that as the process and that the USDA Guidelines, when 
promulgated, would then fill in where Appendices L, M, N, and O now are proposed in the 
NIH Guidelines. 
Dr. Miller asked if recombinant DNA release experiments would still have to go to the IBCs 
under such a framework. Dr. Tolin said they would unless they were exempt. Dr. Wivel said 
there were many such exempt categories and that the IBCs would still have the prerogative 
to look at an experiment and designate a containment level based on risk. 
Dr. Mclvor asked for clarification as to whether this change in wording would result in 
experiments which will release transgenic animals into the environment which are reviewed 
by another agency to not come to the NIH at all. Dr. Wivel said this was correct. Dr. Mclvor 
said that he could not support such a proposal and that he felt these experiments were within 
the realm of recombinant DNA research and should be reviewed by the RAC. 
Dr. Bourquin noted that even if the language were left in the NIH Guidelines, the project 
probably would not be reviewed by NIH, unless that project was supported by NIH funds. Dr. 
Mclvor said that he did not believe this to be true since most of this type of research was 
being done at institutions which did have some NIH support and thus would fall under the 
purview of RAC. 
Dr. Post moved that the RAC accept the proposal, as printed, with the condition that ORDA 
make any other housekeeping changes needed in the NIH Guidelines to be consistent with it. 
Dr. Schaechter seconded the motion. 
There being no further discussion. Dr. McGarrity put the motion to a vote. The motion 
passed by a vote of 9 in favor, 5 opposed, and 3 abstentions. 
Dr. McGarrity then asked the committee to take a short, 5 minute recess, and to reconvene 
to finish the agenda. 
Dr. McGarrity called the committee back to order at 1:30 p.m., and asked Dr. Ledley to 
present the next agenda item. 
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Recombinant DNA Research, Volume 14 
