222 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
eral approach to the controversy; including 
whether or not the problem had been too nar- 
rowly phrased. Similarly, Congress had the 
opportunity in 1977 to reevaluate the entire 
institutional response, taking into account any 
moral objections to the research in addition to 
those concerning safety. Yet the principal bills 
were based on the proposition that the research 
continue in a regulated fashion. 
A related issue is the one of burden of proof. 
Should the proponents of a potentially benefi- 
cial technology be required to demonstrate 
minimal or acceptable risk even if that risk is 
uncertain or even hypothetical? Or should its 
opponents be required to demonstrate unac- 
ceptable risk? If the proposition is accepted that 
those who bear the risks, in this case the public 
as well as the scientists, must judge their ac- 
ceptability, then the burden must be on the pro- 
ponents. The scientific community clearly ac- 
cepted this burden. The moratorium proposed 
by the NAS committee in July 1974 called for a 
suspension of certain types of rDNA experi- 
ments until the risks could be evaluated and 
procedures for adequately dealing with those 
risks could be developed. The Guidelines pro- 
hibited some experiments, specified contain- 
ment levels for others, and required certifica- 
tion of host-vector systems. All actions approved 
by the Director of NIH, including the lessening 
of the restrictions imposed by the original 
Guidelines, have had to meet the requirement of 
presenting “no significant risk to health or the 
environment.” 
Two other criticisms have been directed 
against RAC, particularly in its early days. The 
first concerned inherent conflicts of interest. 
RAC’s members were drawn from molecular 
biology and related fields. One of the early 
drafts of the Guidelines was criticized as being 
“tailored to fit particular experiments that are 
already on the drawing boards. However, 
only a few of the members were actually work- 
ing with rDNA. A more serious criticism was 
the lack of a broad range of expertise. Although 
Wade, “Recombinant DNA: NIH Sets Strict Rules to Launch 
New Technology," 190 Science 1175,1179, 1975. 
“Dr. Elizabeth Kutter, a member of RAC at that time, personal 
communication. Sept. 11 , 1980. 
the risks had been expressed in terms of poten- 
tial hazards to human health and the environ- 
ment, the original RAC had no experts in the 
areas of epidemiology, infectious diseases, bot- 
any or plant pathology, or occupational health. 
It did have one expert in enteric organisms, E. 
coli in particular. 
These shortcomings were eventually rem- 
edied by expanding RAC’s membership to allow 
the appointment of other experts, including 
some from nontechnical fields such as law and 
ethics. In addition to providing knowledge of 
other fields, these members served as disin- 
terested advisors, since they had no direct in- 
terest in expediting the research. Thus, the Gov- 
ernment dealt with the problem of conflicts of 
interest by offsetting the interested group with 
other groups. In view of the need for the tech- 
nical expertise of the molecular biologists, this 
approach seems reasonable; nevertheless the 
matter could probably have been handled more 
expeditiously. Although the April 1975 amend- 
ment to the RAC charter added experts from 
such fields as epidemiology and infectious dis- 
eases, the charter did not reciuire plant expi’i'ts 
until September 1976 (shortly aftei’ the passage 
of the original Guidelines) and occupational 
health specialists until December 1978. In addi- 
tion, while two nontechnical members wen? ad- 
ded in 1976 (one before and one aftei’ passage of 
the Guidelines), their number was not inci’eased 
until Secretary Califano reconstituted the t'om- 
mittee in late 1978. 
The present makeup of RAC is fairly diverse. 
As of September 1980, nine of its members sj)e?- 
cialized in molecular biology or related fields, 
seven were from other scientific disciplines, 
and eight were from the areas of law , public 
policy, the environment, and public or occupa- 
tional health. 23 Moreover, since D(?cemher 1978, 
representatives of the interested Federal agen- 
cies have been sitting as nonvoting members. In 
January 1981, an expert on fermentation was 
added. 
^“Dr. Bernard Talhol, S|)ecial Assislant to Ihi- nii erim MM (wr 
sonal comunication, .Sept. 18. 198(1 
