COVINGTON & BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Nine 
mentions authority for inspection as an enforcement tool. 
Administrative provisions requiring reports or imposing 
other enforcement mechanisms are also clearly authorized. 
Thus, it appears that there is an infinite variety of en- 
forcement mechanisms available, and that any of a number 
could be incorporated into a regulation promulgated under 
Section 361. 
VII 
Questions have been raised about the way in which 
the recombinant DNA research guidelines could be enforced 
if they were proposed and promulgated as regulations under 
Section 361. Clearly, it would not be necessary that the 
same government agency issue the regulations and enforce 
them. It would be possible, for example, for NIH to issue 
the regulations (as it presently does) , and for CDC to en- 
force them. I mention CDC because it has jurisdiction over 
the Clinical Laboratories Improvement Act and thus has 
experience in inspection and enforcement with respect to 
scientific laboratories. FDA might also be in a position 
to enforce the regulations, but its other responsibilities 
are so overwhelming that enforcement of recombinant DNA 
research regulations might better be performed by CDC. 
VIII 
At the recent NIH meeting, representatives of the 
pharmaceutical industry stated that industry intends to com- 
ply with the NIH guidelines and would have no objection to 
making them mandatory if certain specific problems were 
overcome. The principal problem involved their concern about 
submission of trade secret information to NIH. I stated at 
that meeting that this issue exists with respect to all 
regulatory agencies, and that FDA, EPA, and the others have 
resolved it without significant difficulty. 
A Federal statute, 18 U.S.C. 1905, explicitly pro- 
vides that trade secret information provided to the govern- 
ment may not be released to the public by any government 
employee under pain of criminal penalty. FDA — which 
regularly receives trade secret information from the regu- 
lated industry with respect to food additives, new drugs. 
[Appendix A — 265] 
