Recombinant DNA Advisory Committee - 10/16/90 
before final adoption. Dr. McGarrity asked for clarification as 
to whether this meant that the staff would prepare the GLSP 
level, making it consistent with the rest of Appendix K. Then 
the subcommittee would review this and, if the subcommittee 
approves it, it would be brought back at the next meeting of the 
RAC for final approval. Dr. Riley said this is what she had 
envisioned. 
Dr. McGarrity asked if the suggestions by the FDA and UCLA would 
be tentatively accepted along with all the other modifications 
which Dr. Riley presented. She said this would be the case. 
Dr. Atlas noted that if the suggestions from FDA to change two 
requirements in Criteria 14 and 28 were taken this would, in 
fact, be a change from the current NIH Guidelines , He asked if 
the issues of accepting the suggestion of the FDA and the 
approval of the table were a single issue to be put before the 
subcommittee. Dr. Riley said these were separable issues and 
that they will have to be addressed separately by the 
subcommittee . 
Dr. Miller asked whether it would be possible for the RAC to 
approve the revision based upon final review and approval by the 
subcommittee on Revision of the NIH Guidelines , rather than to 
put this issue off until the next full RAC meeting. 
Dr. McGarrity asked Dr. Wivel for an interpretation on this 
proposal by Dr. Miller. He noted that in the past the RAC had 
required approval of the Human Gene Therapy Subcommittee before 
allowing a vote of the full RAC on any proposal, but he was not 
sure whether this ruling was specific only to the Human Gene 
Therapy Subcommittee. Dr. Wivel said that in practice the RAC 
does not vote on any matter under discussion by a subcommittee 
until that subcommittee has cleared it to come before the full 
committee. 
Dr. McGarrity called on Dr. Rebecca Goldburg of the Environmental 
Defense Fund (EDF) to make comments on the proposed change to the 
NIH Guidelines. She said the EDF opposed the changes to Appendix 
K for the following three reasons: 
1. The appendix broadens the RAC's focus from small-scale 
research to large-scale industrial operations; 
2. The Environmental Protection Agency (EPA) is currently 
working on regulations for commercial production of 
chemicals using biotechnology, and the adoption of this 
appendix would create a loophole to bypass the EPA 
rulemaking procedure; and. 
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