6 
tion to commercial firms include, but are not limited to, the need to 
work with greater volumes of material and avoiding unnecessary dup- 
plication or overlap with existing statutes such as the Toxic Substances 
Control Act, the Federal Food, Drug, and Cosmetic Act and the Public 
Health Services Act. 
The Subcommittee believes that legislation to authorize the exten- 
sion of the Guidelines for Research Involving Recombinant DNA 
Molecules should have a definite termination date, perhaps after a 
period of two years, and that the need to continue such regulation 
should then be reexamined. There are important constitutional issues 
of freedom of inquiry which must be carefully considered if scientific 
research is not to be suppressed. The determination of the need to 
regulate and how to conduct such regulating is not always clear, and 
hasty, ill-conceived legislation may produce more harm than good 
to the spirit of free inquiry. There is no question that there is a need 
for Government to protect society when there is a clear threat to that 
society. However, tne determination of this threat is not always an 
easy task and this is the case in the evaluation of the risk from re- 
combinant DNA research. Science is a dynamic process; the public 
often tends to want to “fix” the response permanently. It becomes a 
difficult matter to construct controls sufficiently flexible to provide 
a protective response which can be modified easily as definitions of 
risk become; clearer. 
The Subcommittee concludes that the issue of whether Federal 
preemption should be included in any legislation which may be 
enacted to regulate recombinant DNA research requires careful 
consideration. While Federal regulations for the conduct of research 
generally should apply in order to insure a national standard of 
conduct, and hopefully similar international criteria, State and local 
communities have shown that valuable contributions can be made 
when citizens are adequately informed and interested. Procedures 
need to be established whereby States and local communities can 
provide this type of input and can even seek standards higher than 
those set nationally under special circumstances. The involvement 
of local communities could be assured in a number of ways, but 
broad participation on joint representative committees, such as 
bio-hazards committees holding frequent open hearings, have proven 
to be useful forums for allaying public fears about new and complex 
issues in science. Perhaps local citizens participating in biohazard 
committees monitoring and enforcing actions required by Federal 
legislation could assist in identifying the need for revision of the 
Federal Guidelines and associated legislation 
C. RISK-BENEFIT ASSESSMENTS 
Risk-benefit assessments are not a need peculiar to recombinant 
DNA research. However, it is obvious that it is not possible at the 
present time to use traditional forms of risk-benefit assessment 
which have evolved for other technological applications where quanti- 
fication of the risk, as with radioactive materials, is more readily 
achieved. The evaluation of the future social impact of recombinant 
DNA research is particularly difficult to accomplish because of 
the many intangible factors requiring consideration. Estimates of 
benefit-risk are frequently based upon speculation and such discus- 
[ Appendix B — 57] 
