11 
whatever you have and figure it out yourself" is not better. If RAC 
cannot find a better mechanism than the CDC classification, IBCs and Pis 
Individually will not be able to make better decisions. 
Ms. King said that the central issue is mandatory vs. voluntary guidelines. 
She said she was concerned with questions of process. She referred to 
Er. Baltimore's statement that only a minority of scientists believe there 
may be some safety concerns with respect to recanbinant DNA research. She 
said the public cannot ascertain vrtiether that statement is accurate. The 
RAC did not cross-examine those vrtx) submitted written comments. Ms. King 
said RAC members should be aware of v*iat she considers to be defects in 
process, and, therefore, err on the side of caution in deciding between the 
December 4 and December 7 proposals. 
Dr. Nightingale praised the more extensive attempts to solicit ocmments on 
these proposals than had occurred in the past. As a result of this, the 
canments received were more varied than in the past. Hov^ver, she felt it 
was only one small step in really assessing vhat the public feels. Referring 
back to Dr. Baltimore's statement. Dr. Nightirgale said that disagreement 
does exist within the scientific community on v^iether there are iniqus 
ri^s of recombinant ENA research. She said that a major issie is volun- 
tary vs. mandatory IBCs. She said that the Decanber 7, 1981, proposal 
could be sirrplified and reorganized to make it easier to read and less 
cumbersome. She suggested that Section III-C could be eliminated; that 
the criteria for defining large-scale could be revised to emphasize inoculum 
size rather than volume; that Section IV could be simplified and reorganized; 
that the bureaucracy within IBCs could be greatly simplified; that 
the section dealing with whole or defective viruses could be simplified; 
that Sections III-B-2-a and Section III-B-2-b dealing with etiological 
agents could be conbined; and that all work in nonpathogens could be 
performed at PI containment. She viewsd the December 7, 1981, proposal as 
a first, very positive step towards reducing complexity and restrictions. 
Dr. Levine attempted to address the question of vhy recombinant ENA 
research is singled out for special consideration while other biomedical 
research, using inherently much more dangerous organisms, is not. He said 
the answer is in the historical context. Work with pathogens has had an 
extraordinary safety record for decades. The reason there was so much 
interest in control of recombinant DNA is that recombinant DNA technology 
became available in the 1970s, in an era of regulation. He cited procedures 
for research involving human subjects, which changed drastically in the 
early 1970s. He said he supports these constraints as they protect the 
piislic, as well as individual subjects, and they facilitate cormnnication 
between the public and clinical investigators. He said being responsive 
to the public is very important and if a significant segment of the 
pitolic is still concerned about recombinant ENA, this ccmmittee should be 
sensitive to that concern. He said that he would like to see something 
like the December 4, 1981, proposal ultimately adopted, but not 'immediately. 
[340] 
