APPENDIX J 
is the appropriate locus in light of 
(a) NIH's role as a lead agency in setting the standards, 
(b) the petition by the Environmental Defense Fund to DHEW 
to issue regulations in this area, 
(c) the congressional proposals that placed regulatory responsibility 
in DHEW, and 
(d) the experiences of DHEW' s Center for Disease Control in regulating 
infectious agents, and of its Bureau of Biologies (FDA) in licensing 
the production of biological products, in close cooperation 
with other Federal Departments and agencies. 
This recommendation was formally approved by all members of the Committee. 
The Committee also urges close cooperation and coordination in DHEW between 
the NIH and regulatory agencies to ensure effective implementation of the 
standards set for this research. 
(2) The Scope of Regulation : 
The Committee reviewed at great length the nature and scope of 
regulation. Consideration was given to regulation of all laboratory 
research where hazardous or potentially hazardous substances were employed. 
Dr. Fredrickson reviewed the activities of committees at the NIH other 
than the Recombinant DNA Molecule Program Advisory Committee which have 
been created to study and recommend, if necessary, safety standards 
for other research involving actual or potential biohazards. 
There was general Committee agreement that, for the present, legislation 
should be restricted to recombinant DNA techniques, allowing for sound 
administrative and scientific expertise in developing safety standards 
Appendix J — 17 
