Recombinant DNA Advisory Committee - 7/31/90 
McGarrity noted that legal advice would be given to make sure 
that any language used in effecting this proposed change to the 
NIH Guidelines would be consistent with this legislation as well 
as impact on environmental release which are addressed by the 
U.S. Department of Agriculture and the Environmental Protection 
Agency regulations. 
Dr. Post said it was his understanding that the RAC had already 
allowed local IBCs to take certain categories of work and 
designate they could be done with "good industrial large-scale 
practices." This proposal is merely giving the local IBCs more 
guidance on what constitutes "good industrial large-scale 
practices . " 
Dr. McGarrity said he was not sure that what is currently in the 
NIH Guidelines would apply to effluents coming out of process 
fermenters. This was a major item of concern in the proposal, 
that effluents would have to be sterilized and gases treated 
coming from these closed systems. Dr. Wivel said that this is 
addressed by the qualification that the proposed amendment deals 
with non-toxigenic and non-pathogenic organisms. Dr. McGarrity 
said he would refer this to Dr. Riley's group for further 
discussion and have it brought up again at the October meeting of 
the RAC. 
VIII. Regional Public Hearings: 
Dr. McGarrity called on Dr. Wivel to discuss the regional public 
hearings planned for the fall. Dr. Wivel said that most 
preliminary materials had been distributed as well as the 
schedule of meetings which includes dates, times and meeting 
locations. He said if members of the committee desired changes 
in assigned meeting locations because of travel and schedule 
conflicts that they contact ORDA. 
Dr. Wivel called the committee's attention to the draft of a 
background commentary on the meetings which will be sent to all 
interested parties, and he asked for members' comments on any 
changes that need to be made in this document. He said the 
questions which were included in the document were not meant to 
be inclusive and he welcomed suggestions from members of the 
committee. He said the last two days of meetings had resulted in 
an additional question which he would include in the final 
version of the document. This would pertain to submission and 
review of gene therapy protocols. He asked for comments from the 
committee . 
Dr. Gellert said he felt the question of the use of polymerase 
chain reaction (PCR) as a means of generating "quasi-non- 
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