Recombinant DMA Advisory Committee - 5/30-31/91 
1. Section I-C refers to experiments abroad and that EPA and USD A/ APHIS has 
no jurisdiction abroad; and, 
2. Section III-A-1 states that "If experiments in this category are submitted to 
another Federal agency the RAC will not review them,” and this would then 
remove the requirement for experiments not reviewed by another Federal 
agency to obtain RAC approval. 
Therefore, if paragraph III-A-2 is removed from the NIH Guidelines, all that would be 
required would be the prior approval of the local IBC. Further, this would apply to all 
organisms now listed as exempt under the NIH Guidelines and that this would cause such 
experiments to not even be reviewed by the local BBCs. She said she was not sure that this 
is what was intended by the proposals. 
In conclusion. Dr. Tolin noted that the USDA Guidelines were published for comment in 
February and the comment period closed on April 2, 1991. She said the AGRAC had just 
met and had received 70 comments on those guidelines and she expected revisions would have 
to be made and republished for comment at some future date. She was unsure of a target 
date for implementation of the USDA Guidelines but noted that USDA was collaborating and 
coordinating with other regulatory agencies in this respect as well. 
Dr. Henry Miller of the Food and Drug Administration (FDA) said that he thought the 
AGRAC Guidelines lacked regulatory requirements and teeth because of lack of sanctions 
for violation. Further, he said that continued NIH involvement in deliberate release 
experiments was not necessary, not sufficient, and confounded the ability of regulatory 
agencies to carve out categorical exemptions from what needs to be dealt with on a case-by- 
case basis. He urged the RAC to approve the proposal to delete these paragraphs from the 
NIH Guidelines. 
Dr. McGarrity gave a brief historical outline of the issue of deliberate release as it was viewed 
by the RAC over the years. He noted that the USDA had developed their guidelines with the 
aim of dovetailing with the NIH Guidelines. He said the committee should take a serious view 
of their role as being advisory to the NIH Director and that the real issue was whether a void 
would be created in oversight by removal of these paragraphs. Furthermore, he noted that 
the RAC had not reviewed an environmental release protocol since 1984. 
Dr. Wivel underlined the fact that the removal of these paragraphs would not in any way 
affect the way which local IBCs deal with environmental release and the fact that the RAC 
does not see the proposals is a reflection of the structure which has been developed for a 
decentralized system of review of these protocols. 
Dr. Post asked what would happen if the RAC no longer had responsibility for review and an 
IBC had a problem with review of a proposal. He asked if the AGRAC was properly 
constituted to deal with such situations. Dr. Tolin responded by saying that the AGRAC had 
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