29 
thorough examination of the recommended changes, but the subcom- 
mittee accepts the view that recent findings justify a careful revision 
of the physical and biological containment standards for certain ex- 
periments. There is also a clear need to correct existing procedural 
deficiencies and to devise ways of applying the standards to privately 
supported research activities, including appropriate methods of moni- 
toring and enforcing compliance. Because the sanctions and admin- 
istrative section of the current guidelines are predicated upon the NTH 
grant review process, legislation cannot merely ‘‘extend” the guidelines 
to the private sector. 
For these reasons, the subcommittee favors a provision requiring 
promulgation of standards and requirements necessary to secure and 
maintain compliance as soon as practicable after passage of legislation. 
This approach would permit both substantive and procedural amend- 
ments to the guidelines. The subcommittee strongly supports the 
discretion of the administering agency to make further changes in the 
standards, provided that the supporting evidence is published and 
there is ample opportunity for public comment. In order to avoid pro- 
longed delay in issuing the initial regulations, however, it may be 
necessary to modify the requirements of the Administrative Proce- 
dure Act. 
WHO SHOULD REGULATE 
The recombinant DNA debate has generated a variety of proposals 
for national and local regulatory agencies, commissions, and commit- 
tees. At issue is the extent to which research scientists should be en- 
trusted with responsibility for their own conduct, individually or 
through peer review, or be subjected to external scrutiny and control. 
Related issues are the proper balance between Federal and State or 
local responsibilities and the appropriate role of lay persons in the 
regulation of recombinant DNA research. 
in legislative terms, these issues raise the following questions : First, 
which F ederal agency should have authority to issue and enforce rules 
governing recombinant DNA research ? Second, what apparatus 
should be established to provide expert assessment of the risks associ- 
ated with such research and to recommend measures to protect public 
health and the environment against those risks? Third, what should 
be the responsibilities of institutions and investigators conducting re- 
combinant DNA research? Fourth, should the Federal Government 
preempt the authority of States and localities in the interest of uni- 
form regulation? 
Federal agency 
Several witnesses discussed the merits and drawbacks of leaving 
regulatory authority with the National Institutes of Health. Joseph 
Grady of the Upjohn Co.’s Department of Infectious Disease Research 
and William Rutter of the University of California at San Francisco 
argued that NIH has the greatest expertise for evaluating physical 
and biological containment of recombinant DNA material and should 
therefore be the monitoring agency; but their view was in the minor- 
ity. The NIH Director himself stated that there is “an inherent con- 
flict of interest” in the agency’s both sponsoring the research and act- 
ing as its “policeman.” He also said that NIH has little capability or 
[Appendix B — 288] 
