Recombinant DMA Advisory Committee - 5/30-31/91 
in fact had a situation come up in which an experiment did fall through the crack as far as 
review was concerned and that the research agency sponsoring the research provided an 
environmental assessment so the experiment could be done. She said it was clear from this 
case that IBCs are not yet totally comfortable in making approvals without better guidance 
from the Federal Government and she said this was one of the aims of AGRAC. 
Ms. Buc suggested a compromise might be to delete the requirement that such experiments 
come to the RAC, but leave the possibility in place for RAC deliberation on them if 
requested. 
Dr. Doi noted that from an IBC viewpoint it is felt that USDA is the proper place to review 
these proposals since they have more experience with the kinds of issues being faced in 
agriculture. He said he felt that once the USDA Guidelines are in place the AGRAC will 
be a much better place to review environmental release experiments. 
Dr. Atlas commented that he felt the EPA and USDA were the proper agencies to deal with 
the issues of environmental release once they get their procedures and review structures in 
place. However, he noted that this still left the issue of foreign experiments done with NIH 
funds open, and in fact seemed to leave the local IBC as the only group judging whether a 
project funded by NIH and undertaking an environmental release in a foreign country should 
be approved. He said he felt it was a disservice to the Director of NIH to be removing the 
RAC from this oversight role. 
Dr. Wivel said that the United States participates actively in the OECD meeting in Europe 
and that the current climate in Europe is for stronger regulatory procedures than in the 
United States and therefore the likelihood of vigorous review and more restrictions being 
placed on investigators than in the U.S. 
Dr. McGarrity also noted that paragraph I-C of the NIH Guidelines states: 
"The Guidelines are applicable to projects done abroad if they are supported by NIH 
funds." 
Therefore, any project done, for any purpose, involving recombinant DNA in any way funded 
by the NIH would fall under the jurisdiction of the NIH Guidelines^ regardless of whether the 
sections proposed for removal are in the document or not. 
Dr. Krogstad asked Dr. Wivel to comment on the issue of deliberate release in third world 
countries where it could be expected to be more likely to take place in order to develop new 
crops and where there is less history and tradition of regulation. Dr. Wivel said that there is 
a group of third world countries who are drafting a "Code of Conduct" for environmental 
release experiments, and he said there is sufficient distrust in the third world that they are 
doing this totally separate, rather than as part of any other recognized international groups. 
Dr. Leventhal asked that if the AGRAC was better able to deal with these issues because of 
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Recombinant DNA Research, Volume 14 
