10 
it was stated, has a broader responsibility for enforcing safety 
regulations — and such enforcement should not be limited to NIH 
employees and awardees. 
Generally, those commentators who had attended the public 
hearing in February 1976 also expressed reservations about requiring 
compliance through the patent system. A number pointed out the dif- 
ficulty in exercising regulatory controls through the patent process. 
They urged that regulation might better be carried out by a Govern- 
ment agency responsible for all recombinant DNA research. One 
commentator noted that the universities do not have the capability 
to monitor their licensees for compliance with the Guidelines and 
that, necessarily, such responsibility would have to rest with 
the Federal Government. Another commentator, however, believed 
that the enforcement of compliance by licensees should rest with 
the universities holding the patents. The rationale for this view 
was that the Government has not assumed the primary role of enforcer 
in other patent circumstances and that an exception should not be 
created for recombinant DNA research. 
Ill . Interagency Committee 
A. Mandate of the Interagency Committee 
The Secretary of HEW, with the approval of the President, estab- 
lished in October 1976 an Interagency Committee on Recombinant DNA 
Research chaired by the Director of the NIH. The Committee was chartered 
to review the nature and scope of Federal and private-sector activities 
related to recombinant DNA research, to determine the applicability 
[ 12 ] 
