27 
tal Guidelines) of the NIH guidelines does not resolve a variety of con- 
troversial and technical legislative issues. How should recombinant 
DNA research activities be defined? Should regulation be temporary 
in the expectation that further research will demonstrate the safety 
of all recombinant DNA experimentation or that public concern will 
diminish? Should legislation simply extend the present NIH stand- 
ards to non-NIH- funded research projects or require new regulations 
to be issued? Are the Julv 1976 guidelines or the changes recommended 
to the Director of NIH by the Recombinant Advisory Committee the 
appropriate basis of regulation? What provisions should be made for 
future changes in the standards to reflect new scientific evidence of 
greater or reduced risk? Should legislation exempt from the standards 
experiments that are proven to be safe or to duplicate DNA exchanges 
that occur naturally? 
Several of these questions reflect the concern of the scientific com- 
munity that needless restrictions may be instituted and thereafter per- 
petuated. For example, there have been various proposals to appoint 
a committee of experts to study the evidence relating to the hazards 
attributed to recombinant DNA research and to report its findings to 
Congress and the executive branch within a specified time. Proponents 
of a study commission appear to assume that further scientific investi- 
gation will show that most if not all recombinant DNA experiments 
pose negligible risks to health and the environment. On tlxis assump- 
tion that regulation will be necessary only until the commission has 
completed its work, they favor short-term or “interim” legislation. 
Various witnesses before the subcommittee supported the inclusion in 
legislation of a sunset clause that would compel Congress to reconsider 
the need for regulation of recombinant DNA research after a few 
years. 
The subcommittee also heard proposals to limit the scope of regula- 
tion. Philip Handler urged that only P3 and P4 facilities be required 
to be licensed and inspected. Halvorson would exempt Pl-level experi- 
ments from all regulation. Others have recommended that the law 
direct the Secretary to identify “non-novel” experiments, producing 
DNA recombinants that are known to occur in nature and are there- 
fore presumably safe; these would be exempt from regulation alto- 
gether. Alternatively, the definition of recombinant DNA research 
activities could exclude certain kinds of experiments. 
A related issue concerns the pending revisions of the physical and 
biological containment standards required by the July 1976 guidelines. 
These changes were recommended by the NIH Recombinant Adv'sory 
Committee, published in the Federal Register on September 27. 1977, 
and are now being considered by the Director. In the subcommittee^ 
hearings, representatives of environmental organizations argued that 
no conclusive evidence exists to justify relaxation of the present stand- 
ards. On the other hand, several scientists, while approving some 
prohibitions and restrictions on experiments, are convinced that these 
requirements are too stringent, at least with respect to uses of E. roll 
K-12 host-vector systems. They preferred that the proposed revisions 
of the guidelines be the basis of regulation under new legislation. A 
number of witnesses urged that any future administrator have author- 
ity to modify the standards in light of new scientific data, whether such 
[Appendix B — 286] 
