Attachment IV - Page 2 
& 06 EQT €. milCHCLL 
A T law 
April 5, 1985 
Dr. Bernadine Healy Bulkley 
Page Two 
The following specific recommendations were adopted by the 
Working Group: 
1. All laboratory research conducted by university or 
industry laboratories, using kecomb inant DNA and RNA, regardless 
of its potential or eventual applications, is appropriately 
overseen, and should continue to be overseen by RAC under NIH 
guidelines. Any new regulatory scheme should confirm that 
laboratory research continue to be exempt from regulation per se. 
Other agencies may want to urge their applicants to abide by 
NIH guidelines during the laboratory phase of commercial product 
development. 
2. Flexibility has been critical in the development of 
this technology and the establishment of its guidelines. This 
flexibility should be retained . The Working Group strongly 
recommends that sufficient flexibility be incorporated into the 
oversight program of other agencies in order that they remain 
current with expanding technology. 
3. Open discussion in public meetings by RAC, particularly 
of generic issues, has been very important, and has helped to 
ensure public input and confidence in policy decisions in this 
field. Therefore, while specific decisions on certain proposals 
may necessarily be made in closed sessions at individual agencies, 
it is important that the Biotechnology Science Board continue to 
provide and encourage public forums at every level, and to the 
fullest extent possible. 
4. On the basis of information acquired over the last 
10 years, RAC has exempted some classes of experiments from all 
special review, and assigned to institutional biosafety commit- 
tees the responsibilities for oversight of other experiments. 
This has .permitted RAC to concentrate on the cases which are of 
major concern. We feconmend that the exempt classes of experi - 
ments be considered carefully as examples of possible categories 
"6t experiments which might be' appropriate for expedited review. 
Not all applications should be required to be subject to the 
full review structure. 
5. That the oversight function should, in the futur e, 
be performed at a Cabinet-level agency such as proposed . The 
OEfice of the Assistant Secretary of Health appears to be an 
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