26 
measures adopted in numerous other countries. The further possibility 
that such a disease would be resistant to present methods of preven- 
tion and treatment enhances the reasonableness of these measures. 
Section 361 does refer only to communicable diseases affecting hu- 
man beings. Presumably, there are or will be recombinant DNA ex- 
periments that could pose a risk of injury to plants, animals, or the 
environment but not of human infection. If necessary, however, the 
protection of nonhuman animals and plants might be achieved in 
cooperation with the Secretary of Agriculture using his authority 
under the animal quarantine laws (21 U.S.C. Ill, 111, 111(b), 123, 
and 131(a)) and the Federal Plant Pest Act (7 U.S.C. 150bb and 
150dd), which are similar in purpose and structure to section 361. 
(See letter from the Secretary of Agriculture in appendix.) 
In any event, according to recent court opinions, the National Envi- 
ronmental Policy Act (12 U.S.C. 4321 et seq.) imposes a duty on 
Federal agencies to protect the environment in all major actions 
whether or not an authorizing statute specifically provides for envi- 
ronmental protection. 
Of greater concern to the subcommittee is whether an effective and 
appropriate regulatory system could be established under section 361. 
Its use to prohibit certain binds of scientific experiments, prescribe 
standards for the conduct of others, certify research facilities, or reg- 
ister research projects would indeed be unprecedented. The act would 
not limit the power of State and local governments to impose stand- 
ards at variance with the Federal standards. The criminal penalties 
in section 361 would be inappropriate except for the most serious 
willful violations of the regulations that result in harm. Nevertheless, 
the agency is the appropriate one and the delegation of authority 
broad. The Secretary or Surgeon General would not be encumbered by 
specific statutory requirements in revising or rescinding regulations as 
warranted by new scientific evidence. There is also merit in avoiding 
the necessity for Congress to legislate, perhaps repeatedly, in highly 
technical areas of scientific research that are conceivably but not dem- 
onstrably hazardous. 
The subcommittee has not reached a final judgment on the legal is- 
sues relating to the use of section 361 of the Public Health Service Act 
to regulate recombinant DNA research. In view of the Secretary’s ap- 
parent desire for specific new authority for this purpose, the subcom- 
mittee believes that legislation is the more likely and preferable course 
of action. However, the subcommittee recommends that the Secretary 
of HEW give serious consideration to promulgating standards and 
procedures under the authority of section 361 if Congress does not 
complete action on legislation or if the legislative committees with jur- 
isdiction conclude that existing authority is adequate. The Secretary 
should prepare for this contingency. The testimony before the sub- 
committee left no doubt that the application of NIH standards to all 
recombinant DNA research should be accomplished as expeditiously 
as possible. 
SCOPE, IMPLEMENTATION AND DURATION OF LEGISLATION 
The consensus that regulation of all recombinant DNA research 
should be “based” on sections II (Containment) and III (Experimen- 
ts Appendix B — 285] 
