VIII 
or possibly by administrative action under the authority of section 361 
of the Public Health Service Act, which in the past has been used to 
control a variety of infectious and some noninfectious agents. The Sec- 
retary of HEW has expressed a preference for a specific legislative 
mandate. If Congress does not act on legislation, however, the Secre- 
tary should reconsider using the authority of the Public Health Serv- 
ice Act. 
In either case, recombinant DNA should be defined as broadly as it 
is defined in the current NIH guidelines. It is also assumed that the 
standards for research will be similar if not identical to those required 
by the guidelines, which prohibit certain presumably dangerous ex- 
periments, require certification of the safety of host-vector systems, 
and prescribe physical and biological containment measures for the 
conduct of permissible experiments. The administering agency should 
have authority to revise the standards periodically, provided tnat there 
is opportunity for public comment and examination of the supporting 
data. There should also be authority to exempt from the requirements 
those classes of experiments that are shown to pose no significant risk 
to health or the environment and to waive the ban on particular experi- 
ments whose results are necessary to assess the risks of recombinant 
DNA research. In all of these actions the administrator should have 
the advice of a group of qualified scientists and laypersons, including 
members of the present NIH Recombinant DNA Molecule Program 
Advisory Committee. 
The subcommittee recommends that institutions be certified to con- 
duct recombinant DNA research. The certificate should be conditional 
upon the appointment and conduct of an institutional biosafety com- 
mittee to approve research projects, certify laboratory facilities, pro- 
vide for the training of laboratory workers and researchers, monitor 
the health of persons exposed to recombinant DNA materials, and keep 
such records and make such reports as are deemed necessary. For in- 
formational purposes, research projects should be registered in ad- 
vance with the administering Federal agency. Because it would be 
inappropriate to disqualify an entire institution in the event of viola- 
tions by a single or a few researchers, the F ederal administrator should 
have authority, subject to procedural safeguards, to suspend the activi- 
ties of such offenders for a period of time. In cases of serious knowing- 
violations of the standards, civil penalties would be appropriate. Fed- 
eral agencies sponsoring or conducting recombinant DNA research 
would retain authority to terminate funding of activities being con- 
ducted in violation of the standards. Certification, registration, in- 
spection and reporting responsibilities should be delegated to the Cen- 
ter for Disease Control or another agency apart from NIH. To protect 
the confidentiality of trade secrets and patentable inventions, there 
should be a procedure for notifying and consulting with researchers, 
both publicly and privately funded, prior to disclosure of information 
by the Government. 
The subcommittee recommends that legislation contain a limited pre- 
emption provision barring States and communities from prohibiting 
recombinant DNA research or imposing physical and biological con- 
tainment requirements exceeding the Federal standards. However, 
[Appendix B — 259] 
