Recombinant DNA Advisory Committee - 7/31/90 
Dr. Epstein said he could understand the need for consultation, 
but outside of the framework of a formal meeting and Federal 
Register notification. Dr. Miller replied that a consultation 
could be done during a regular subcommittee meeting, or by 
consulting with individual members of the HGTS who are expert in 
certain areas. He noted that scientific experts at FDA, who are 
bench scientists, are also willing to consult on these issues. 
Dr. McGarrity said he did not know if the committee had been 
spoiled by the protocols it had received thus far, but that the 
standard for future applications has been set for everyone else. 
He noted that Dr. Wivel does consult with investigators 
extensively and that is part of the duties of ORDA. 
Dr. Parkman said he thought people go away disappointed when 
their expectations are not fulfilled. The committee should make 
it very clear that the review of a proposal is different from 
responses to "think pieces." He said this may lessen some of the 
disappointment. He said the St. Jude's proposal could have been 
handled much more expeditiously if this had been the case. The 
committee could have spent a short time letting the investigators 
know about the deficiencies in the protocol without having to go 
through educating the entire committee to the proposal and 
discussing it in detail. 
Dr. Parkman said that the issue of the dual role (consultation 
and review) of the HGTS is something that needs to be looked at, 
but that probably it could perform this function for another year 
or two. Ultimately, the consultative role would have to be 
accomplished outside of regularly scheduled meetings. For the 
present. Dr. Parkman said he would like to see the subcommittee 
continue both these functions. 
VII . Discussion on Review of Appendix K of the "NIH Guidelines"; 
Dr. McGarrity called on Dr. Riley to begin the discussion of this 
agenda item. Dr. Riley said the Industrial Biotechnology 
Association (IBA) and the Pharmaceutical Manufacturers 
Association (PMA) had proposed that Appendix K of the NIH 
Guidelines be modified to make it possible for large scale, i.e., 
greater than 10 liters, culture of organisms produced with 
recombinant DNA techniques to be dealt with at a safety level 
described as "good industrial large-scale practice." This class 
of organisms is harmless (described as non-pathogenic, non- 
toxigenic, not producing toxins, and in other ways considered 
safe) . She noted that safety level had been adopted for use by 
the Organization for Economic Cooperation and Development (OECD) , 
a European based international organization, for dealing with 
large-scale work with microorganisms. 
Recombinant DNA Research, Volume 14 
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