Recombinant DNA Advisory Committee - 03/1-2/93 
X. ADDITION TO THE POINTS TO CONSIDER OF THE NIH GUIDELINES 
REGARDING THE SAFETY OF DELIVERY /EXPRESSION SYSTEMS AND REPORT 
ON MURINE RCR ASSAYS/DR. MILLER 
Review— Dr. Miller 
Dr. Walters called on Dr. Miller to initiate discussion of the document entitled: Safety of 
Delivery /Expression Systems and Report on Murine RCR Assays, submitted by Dr. W. 
French Anderson of the Southern California School of Medicine, Los Angeles, and Drs. 
Gerard J. McGarrity and Robert Moen of GTI, Gaithersburg, Maryland. 
Dr. Miller asked if the report was being considered for inclusion in the Points to Consider 
or for endorsement by the RAC as a state-of-the-art guide for investigators about the 
recommended procedures for RCR testing. Dr. Wivel explained that the report was 
included as a proposed action to the Points to Consider and published in the Federal 
Register to provide the RAC with the option to include specific RCR assay requirements 
and minimal levels of RCR detection if necessary. Addition of language to the Points to 
Consider by the RAC is an option, not a directive. 
Dr. Miller explained that the investigators originally submitted an RCR report to the 
RAC at the December 1992 meeting. At that meeting, the RAC made several 
recommendations regarding additions and corrections to the report. This revised report 
incorporated all of the RAC's suggestions and is a comprehensive summary of murine 
RCR assays. The report should not be included in the Points to Consider due to the 
rapidly evolving nature of the field. This report should be used as a guide for those 
investigators who are considering submission of human gene transfer protocols which 
involve murine retrovirus vector. 
Review-Miller (for Dr. Geiduschek) 
In Dr. Geiduschek's absence, Dr. Miller summarized Dr. Geiduschek's written critique of 
the report. Dr. Geiduschek's comments indicated that he is satisfied with the revised 
version of the report. In particular, he was pleased to see that a section was included 
that analyzed the dynamics of RCR breakout events. Dr. Geiduschek states that, "The 
report is to be regarded as a review of status, not as a final resolution of the safety 
issues." Dr. Geiduschek outlines the following stipulations for endorsement of the 
report: (1) that the experiment cited on pages 191 and 193 (RAC mailing) are to be 
repeated sufficiently to establish a time criterion for breakout events, and (2) the fraction 
of each production lot that will be monitored should be large, i.e., a minimum of 5%. 
Dr. Geiduschek's written comments indicate that the investigators have agreed to these 
stipulations, and that these provisions coincide with their own activities and plans. 
Recombinant DNA Research, Volume 17 
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