Recombinant DMA Advisory Committee - 5/30-31/91 
greater expertise, whether they could not simply be dropped from the NIH Guidelines and a 
note sent to the AGRAC to make sure that the categories of experiments now covered in the 
NIH Guidelines be included in the USDA Guidelines? Dr. ToUn said the only problem with 
this was that they could not have oversight over experiments which are not funded by USDA 
Therefore they could not require review of NIH-funded deliberate release experiments. 
Dr. Atlas said he felt a crucial issue was the trigger for national review could be deleted while 
maintaining the ability for an IBC to send a protocol forward which it was not able to deal 
with for some reason and still expect it to be reviewed by the RAC. Dr. Wivel said that not 
only could they do this, but in fact, they frequently write in asking guidance from the RAC 
which is normally supplied by ORDA without bothering the RAC. He said the removal of 
these paragraphs would in no way affect this ability to consult and, indeed, request RAC 
review of a protocol by a local IBC. 
Dr. Carmen brought up the issue of regulation of transgenic animals. Dr. Tolin said that if 
recombinant DNA were involved the NIH Guidelines would apply. Dr. Miller noted that there 
were other ways to make transgenic animals, without using recombinant DNA and that these 
are not covered by the NIH Guidelines. Dr. Carmen asked if the RAC were not a suitable 
forum to review such experiments because of the traditionally ethical, humanistic manner in 
which it has viewed recombinant DNA research. He asked Dr. Wivel to comment on the 
situation in which an experiment was being proposed which would fall under the NIH 
Guidelines and whether the RAC would feel that since another Federal agency was reviewing 
it that may not have the same expertise, it should be reviewed by the RAC. Dr. Wivel said 
the question would really be one of risk assessment, level of risk and level of containment 
needed to negate the level of risk. 
Dr. Mclvor said a distinction should be made between a naturally genetically manipulated 
animal and a transgenic animal, and that furthermore what is really being discussed in this 
proposal is microorganisms, rather than plants or animals. However, he said if transgenic 
animals were to be included in this proposal he felt that this needed to remain under RAC 
purview. 
A long discussion ensured over the issue of transgenic animals in which Dr. Mclvor continued 
by noting his feeling that the RAC was the proper place to review such issues. Dr. Wivel 
noted that this came back to the issue of product versus process, and that if the product, the 
transgenic animal, produced no risk to the environment that there was no reason to review 
the release unless such risk were possible. Furthermore, he added that the RAC did not 
possess the expertise in many of these areas to assess this risk. Dr. McGarrity added that the 
'Talbot Amendment" would still come into play and that if another agency were reviewing 
such experiments the RAC would not review such experiments unless they were funded by the 
NIH. 
Dr. Schaechter said he felt these discussions were far afield from the question of why the 
RAC would maintain any function that is not purely recombinant DNA He said that human 
gene therapy was an "exception" to this philosophy. He noted that the NIH Director had 
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