24 
or cloning systems to be used in the DNA recombinant molecule 
research and provides recommendations to the Director for adoption 
or rejection of such systems. The Advisory Committee to the Director 
of NIH has had the task of assisting the Director in reviewing the 
recommendations of the DNA advisory committee and comments 
from the public. Both of these advisory committees have membership 
not only from the scientific community but also from other disciplines 
such as law, ethics and consumer affairs. Copies of the guidelines and 
of the proceedings of the meetings of these advisory committees 
are widely disseminated to the public and are available upon request. 
Further, the NIH has established a new Office of Recombinant 
DNA Activities to administer and coordinate intramural and extra- 
mural activities at NIH; to review the institutional biohazards 
committees which are required by the guidelines; and to monitor 
reports and information concerning accidents, containment and 
safety research innovation. The other area of importance has been 
the drafting of a proposed Environmental Impact Statement on DNA 
recombinant research. 
Extension of Guidelines 
A separate task of the Federal Interagency Committee on Recom- 
binant DNA Research, created with the approval of President Ford, 
was to examine the need to extend the NIH guidelines to the public 
sector or private sectors not funded by Federal funds. This committee 
reviewed the actions being taken by other nations of the world 
to control or regulate DNA research. As Dr. Fredrickson noted, sev- 
eral countries have already established their own guidelines to govern 
such research. The Director indicated that he had personally visited 
several of the Western European Nations to discuss this issue. It ap- 
peared at the time of his testimony that the regulatory work in other 
nations is being carried out almost entirely by advisory committees, 
some of them quasi-govemmental, others private in nature. The de- 
bate on this issue in these other nations has not been as widespread 
or time consuming as it has been in the United States. There seems to 
be general agreement that the standards for regulating DNA recom- 
binant research should be uniform on an international basis. With the 
evolution of uniform guidelines, a major task now seems to be to try 
and develop a more or less uniform method of insuring that the guide- 
lines are enforced. 
In reporting further on the work of the Federal Interagency Com- 
mittee on DNA Recombinant Research, the Director indicated that 
this body also had examined the applicability of existing legislation to 
provide regulatory authority. The committee’s conclusion was that no 
single legal authority or combination of authorities now exists that 
clearly permits regulation of all research or other uses of recombinant 
DNA techniques. Among the conclusions reached by the committee 
in terms of needed authority, agreement was reached that: (1) regis- 
tration of projects involving the use or production of recombinant 
DNA molecules is needed; (2) facilities should be licensed including 
an acceptance by the facility of responsibility for the activities at the 
facility; (3) a single set of national standards should govern and local 
law should be preempted to insure national standards and regulations ; 
(4) DHEW should continue to cooperate and coordinate with relevant 
Federal departments or agencies in this matter. 
[Appendix B — 73] 
