Attachment III - Page 1 
WORKING GROUP ON P ICff’EEHNOLOGY COORDINATION 
RECCMRINANT DNA ADVISORY COMMITTEE 
MARCH 1, 1985 
POINTS FOR CONSIDERATION 
1. All laboratory research using recanbinant ENA and FNA regardless of its 
potential or eventual applications is appropriately overseen and should 
continue to be overseen by the Recanbinant ENA Advisory Committee (RAC) imder 
the NIH Guidelines. Any new regulatory scheme should confirm that labora- 
tory research continue to be exempt from regulation per se. Other agencies 
may want to urge their applicants to abide by the NIH Guidelines during 
the laboratory research phase of commercial product develcpment. 
2. Flexibility has been critical to NIH's development of the Guidelines in 
this rapidly develcping field. NIH's flexibility should be retained, and 
we strongly recommend that sufficient flexibility be incorporated into 
oversight by other agencies. 
3. Open discussion of the appropriate use of biotechnology by the RAC has 
helped to insure public input into and confidence in policy decisions 
in this field. Therefore, vhile specific decisions on specific applications 
may necessarily be done in closed sessions, it is important that scientific 
oversight committees continue to provide a public forum to the extent 
possible. 
4. On the basis of data acquired over the past ten years, the RAC has exempted 
some classes of experiments from all special review and assigned to the 
Institutional Riosafety Committees the responsibilities for o/ersight 
of other experiments. This has permitted the RAC to concentrate on 
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