35 
Federal preemption upon the presentation of convincing reasons in 
support of stricter standards. A State or political subdivision would 
be permitted to take other actions to assure its citizens that the Federal 
standards were being observed. These actions include registering and 
inspecting facilities, requiring public representation on the institu- 
tional biosafety committee, investigating alleged violations of applica- 
ble regulations, and seeking an injunction to stop a violation. A State 
would also have standing in Federal court to obtain injunctive relief r 
pending an investigation and appropriate action by the Secretary, in 
the unlikely emergency that an activity being conducted in compliance 
with the regulations were found by the court to pose an imminent 
threat to the health of laboratory workers or the general public. Fin- 
ally, a State, community, private organization or citizen should have 
an opportunity to comment to the Secretary on an application to con- 
duct recombinant DNA research. 
PROCEDURES 
A large majority of NIH research grants are made to institutions 
rather than individuals, but it is the principal investigator who bears 
primary responsibility for compliance with the NTH recombinant 
DNA research guidelines and can be held accountable for disregarding 
them. Among other duties, he or she must submit with the grant 
application to NIH a Memorandum of Understanding and Agree- 
ment (MUA), certified by the institutional biosafety committee, and 
describing the proposed experiment and the procedures and facilities 
that will be used to achieve the required levels of physical and bio- 
logical contaimnent. The NIH Office of Kecombinant DNA Activities 
must review and approve or disapprove the proposed MUA before 
the work can begin. In the event of a violation of these procedures or 
standards, NIH’s only recourse is to deny the use of grant funds 
for recombinant DNA experiments or halt further expenditures of 
grant funds if the experiment is in progress. The latter may be an 
embarrassment to the institution but is a relatively severe sanction 
for the principal investigator and his colleagues on the project. NIH 
has taken this action in only one instance, upon discovering that no 
MUA had been approved, as required, for a project begun before the 
guidelines were issued. 
Witnesses before the subcommittee acknowledged the need to devise 
new procedures applicable to privately supported research activities. 
What impressed the subcommittee, however, was the degree of con- 
sensus on elements of a regulatory system appropriate to both the 
academic and industrial sectors. Stetler of the PMA, Halvorson of the 
ASM, Joseph Keyes of the American Association of Modi cal Colleges, 
and OSTP Director Frank Press all advised against licensure of in- 
dividual researchers as “onerous and burdensome” but recommended 
a system of Federal licensing of facilities to conduct recombinant 
DNA work. They said that revocation or suspension of such a license 
would be an effective deterrent to misconduct. Stetler also proposed 
the registration of individual research projects with the Federal 
agency, although primarily for informational purposes. Gradv of 
Upjohn suggested that researchers file the equivalent of an MUA, 
[Appendix B — 294] 
