Recombinant DMA Advisory Committee - 5/30-31/91 
Guidelines. 
Dr. McGarrity called on Dr. Wivel for his comments. Dr. Wivel noted that Section III-A of 
the NIH Guidelines describes the four triggers for national review which includes experiments 
involving both human gene therapy as well as deliberate release into the environment. He 
said removal of the deliberate release experiments from this section would not preclude the 
review of environmental release experiments by a local IBC. He noted that this was covered 
in Appendices P and Q of the NIH Guidelines. He said this would simply result in the trigger 
for RAC review being removed. 
Dr. Hirano asked where Appendices P and Q were in the NIH Guidelines. Dr. Wivel 
explained that these appendices had been completed and approved by the RAC, however an 
environmental assessment had still to be completed before they could be officially included 
in the NIH Guidelines, but that investigators are provided with these appendices and advised 
that they are to be viewed as guidance for the investigators although they are not included in 
the formal document yet. 
Dr. Hirano said she had spoken with her local IBC relative to this issue and that they said 
they would be concerned if RAC removed itself from this arena completely insofar as they 
rely on the RAC as a "safety net" for their deliberations. 
Dr. Krogstad said that he had originally felt in favor of the proposal, however that he felt Dr. 
Hirano's points were valid. He said on one hand he felt the trend has been away from RAC 
review of these proposals, however what was needed was a practical way to remove RAC from 
the process without leaving a void in the review process and he said he thought this is the 
process which needed to be addressed. 
Dr. Haselkom said he had no difficulty with the proposed amendments since 99.9 percent of 
the cases are outside the purview of the RAC at this time and most were of an industrial 
nature. Further, he noted that there had been no cases of harm to the environment from any 
experiments conducted thus far. 
Dr. McGarrity called on Dr. Sue Tolin from the USDA for her comments. She said it was 
the position of the USDA that ultimately RAC should not be in the business of reviewing 
experiments dealing with release into the environment and she noted they had been actively 
seeking a mechanism to supply guidance to investigators, whether in academic institutions or 
in industry, but that this mechanism is not yet in place. She noted that USDA was actively 
involved in formulating Appendices P and Q, but noted that even they did not cover planned 
introductions outside of a controlled environment with the exception of at the lowest levels 
in animals. 
Dr. Tolin said she favored deletion of the particular clauses called for in this proposal but that 
she envisioned two problems: 
[654] 
Recombinant DNA Research, Volume 14 
