28 
evidence reveals that the risks are greater or less than is now thought 
to be the case. 
There have also been various suggestions for incorporating the 
guidelines in law. The simplest approach is said to be a provision that, 
upon enactment of legislation, the guidelines will be applicable to all 
sponsors and conductors of recombinant DNA research without fur- 
ther administrative action. A second alternative, which anticipates the 
need for procedural provisions appropriate to the private sector, is to 
extend the guidelines as interim rules and require the promulgation 
of final regulations within a specific period of time. Third, Congress 
could dispense with the interim extension of the guidelines and require 
that comprehensive regulations be issued. 
Views of the subcovrumittee 
The subcommittee believes that knowledge of the effects of recom- 
binant DNA experimentation will be acquired over the course of years 
in the normal process of scientific investigation. Progress in assessing 
its safety will be accompanied by rapid development of the technique 
and use of a variety of host-vector systems, each requiring evaluation. 
From this perspective, the subcommittee prefers the creation of an ad- 
visory apparatus, including scientists and lay persons, operating on 
a continuing basis rather than a special commission directed to reach 
a final judgment within an arbitrary time period. When the prospec- 
tive uses of recombinant DNA techniques are better known, it will be 
necessary to address the moral and public policy issues of human ge- 
netic engineering, perhaps by a Government-appointed group of ex- 
perts and laypersons. Because these advanced applications are not 
yet subject to verification or regulation, however, the subcommittee 
believes that legislation should deal only with the health and environ- 
mental consequences of recombinant DNA research. On the other 
hand, it sees merit in a sunset provision to insure a reassessment of 
both the need for and effectiveness of Federal regulation. Since these 
judgments cannot be made for some time after the regulations become 
effective, the subcommittee recommends that the law expire no earlier 
than 3 years after its enactment. 
The legislation’s definition of recombinant DNA should be the defi- 
nition in the current NIH guidelines. The administering agency should 
have authority to remove restrictions on certain categories of experi- 
ments ; but the criterion should be that the experiments pose no signifi- 
cant risk to public health or the environment, and the test procedures 
and criteria for assessing such risks should be published with the regu- 
lations. The concept of “non-novelty” is ambiguous and not invariably 
indicative of safety. The subcommittee recognizes a certain anomaly 
in restricting operations that occur in nature but believes that the 
basis for removing such restrictions should be consistent with the 
purpose of the legislation. To insure that important risk- assessment 
studies can be carried out, the subcommittee recommends that the 
administrator be authorized to waive the ban on presumably dangerous 
research for individual experiments to be conducted under specified 
conditions and supervision. 
The scheduling of the subcommittee’s hearings shortly after pub- 
lication of the proposed revision of the guidelines did not permit a 
\ 
[Appendix B — 28 7 ] 
