10 
ever recxnbinant ENA. RAC would ^d^o continue to deal with issues surround- 
ing the prohibitions. He hoped RAC could deed with genered issues of bio- 
heizards euid would aid OXT in formulating the CDC guidelines. Dr. Baltimore 
said the proposal would not greatly affect industry eis industry has volun- 
tarily accepted adherence to the Guidelines. Lastly, Dr. Baltimore quoted 
frem a letter from Dr. Zinder (tab 1017). "It would be an important prece- 
dent for the NIH to disnantle the unneeded regulatory structure. If scien- 
tists are ever aigain to attempt to cope with potenti^d hazeurd, they must 
see that »4iat they believed were temporary measures can be undone." 
Dr. Harris said that examination of the RAC's actions in the last two 
years indicates a gener 2 d movement in the direction the authors propose. 
Although she agreed in principle with the ration^de supporting the prcposal, 
she said she felt waiving NIH and RAC responsibilities in this curea is a 
giant leap deserving very careful evaluation and consideration. She agreed 
that little evidence to date supports the generad public concern about 
potentiail hazards of recombinant EKA, but pointed out that public concern 
and distrust of bioprocessing technologies continues, particularly with 
those technologies v4^ich lend themselves to hunan genetic applications. 
The RAC and the NIH Guidelines both have served to in^ire pi±)lic trust 
and confidence. She said it is her strong conviction that the Guidelines 
have precluded precipitous regulation by local governing groups, by other 
federad agencies, and by Congress; regulations v*iich, if enacted, would 
have stifled inno/ation. Prerature abrogation of the Guidelines might 
sJcew future regulation and public policy. 
Dr. Harris said she personally is more ocmfortable with the recommendation 
to reduce containment levels tham with the proposal to convert the Guide- 
lines to a code of standaund practice. She proposed a two-stage process in 
vhich RAC would consider the recommended reduction in containment levels, 
vhile postponing consideration of converting the Guidelines into a non- 
regulatory code. Dr. Pedoroff and Ms. King endorsed Dr. Harris' statement. 
Ms. King noted Dr. Zinder's plea that scientists "must see that v*iat they 
believed were temporary measures can be undone," but ailso added that the 
public must see that if the RAC undoes the Guidelines, it does so in a 
responsible manner. She agreed that the Guidelines should be reassessed 
and reevaluated. She suggested that RAC or a RAC subcommittee should 
underta)ce such a reevaluation. She urged that public irput should be 
solicited, and observed that a Federal Register announcement is not ade- 
quate. She felt debate with input fron other sectors is important in 
formulating a recommendation concerning the Guidelines. 
Dr. Nightingale said the process by which the status of the Guidelines 
would be altered will greatly influence public acceptance of that alteration. 
Dr. Harris said that process is of primary iitportance because if the public 
perceives the action as inappropriate, a badclash could result. She said 
the process will entail education of concerned citizens. Dr. Brill and 
Ms. King expressed the belief that there is very little public distrust of 
the scientific community in the area of recombinant CNA. The public is 
1991 
