18 
existing Guidelines. It is the committee’s view that this procedure 
being followed by the NIH is the most appropriate to produce deci- 
sion documents and put changes into effect as rapidly as possible and 
in accordance with the Administrative Procedures Act. The provi- 
sions of H.R. 11192 should not imply that any change in the guidelines 
automatically requires the completion of the longer procedures re- 
quired for processing an EIS on all actions. The Secretary should 
have freedom to move expeditiously to make changes in the Guide- 
lines as necessary to protect the environment and health, but he should 
be equally free to insure an optimal environment for research. The 
assessment procedure to determine the need for an EIS should pro- 
vide maximum flexibility during the experimental period Of this 
legislation. 
Conflict of Interest 
In, a dissenting view to the report of the Committee on Interstate 
and Foreign Commerce, several Members expressed a concern, that 
“H.R. 11192 places NIH, through the Secretary, in the position of 
being both promoter and regulator, a situation similar to that of the 
nqy-clefunct . Atomic Energy Commission. There is an Obvious con- 
diet of interest inherent in this situation.” Based on the Administra- 
tion’s plan for implementation of the regulatory provisions of this 
bill, as outlined in testimony before the subcommittee, it is doubtful if 
such an inerent “conflict of interest” exists. Regarding earlier legisla- 
tive proposals the Administration stated that : 
NIH [will] recommend the revisions in the guidelines, re- 
view and clarify the technical issues, and handle, if you will, 
the standard setting, the philosophy, the scientific input, and 
then turn over to [the Center for Disease Control] the func- 
tions of licensing facilities and maintaining the registry and 
operating and promulgating standards. Both organizations 
would obviously have to be involved in training workers and 
in working with those outside the Federal Establishment as 
well as inside that are involved in recombinant DNA 
research. 
The record also shows that : 
NIH, for the past 18 months, has worked closely with 
the . . . (CDC) concerning safety aspects of the Guidelines. 
. . Close coordination and consultation with the Food and 
Drug Administration and the Environmental Protection 
Agency will be essential since these agencies’ regulatory au- 
thorities will come into play when recombinant DNA research 
inventions are ready for commercial development. The Occu- 
pational Safety and Health Administration will exercise its 
regulatory authority in the workplace. 
The committee’s interest in resolving potential conflict of interest 
situations within NIH stems not only from usual concerns, but also 
from a concern that turning NIH into regulatory agency would do 
great damage to its principal function — the support of high quality 
research. The committee is satisfied that efforts are being made to meet 
these concerns. 
[Appendix B — 206] 
