79 
I am unclear as to the specific regulatory authority of the Sec- 
retary under Section 361. Please provide a comprehensive analysis 
of the Secretary ; s total authority under Section 361 to regulate 
recombinant DNA research and related activities, including but 
not limited to the following items : 
a. extension of the NIH guidelines to non-Federally funded 
research ; 
b. authority to license facilities ; 
c. authority to inspect facilities ; 
d. authority to promulgate regulations for administration and 
enforcement of the guidelines ; 
e. sanctioning authority with respect to civil penalties, injunc- 
tive authority, and criminal penalties ; 
f. role of local biohazard committees. 
— Please compare the authority of the Secretary regarding recom- 
binant DNA research and related activities under Section 361 
with the authority of the Secretary under Senate Amendment 1713 
and H.R. 11192. 
— Does the Secretary have authority under Section 361 to preempt 
State and local actions concerning recombinant DNA research 
and related activities? 
To assure that the Senate is informed on these very important issues 
prior to consideration of the pending legislation, I would request that 
you respond to this letter by May 13, 1978. Thanlc you for your con- 
tinued cooperation. 
Very truly yours, 
Harrison H. Schmitt. 
U.S. Senator. 
ATTACHMENT G 
Executive Office of the President, 
Office of Science and Technology Policy. 
Washington , D.C., May IS. 1978. 
Hon. Harrison H. Schmitt, 
U.S. Senate . 
Washington , D.C. 
Dear Jack: Thank you for your letter of May S, with questions 
about current legislation which would regulate recombinant DXA 
research and its applications. 
Many of the issues you have raised, of course, we have discussed in 
previous correspondence and during the hearings on November 8 and 
February 10. As Gil Omenn testified to the House Science and Tech- 
nology Subcommittee on April 11. we do support the passage of H.R. 
11192. A copy of that testimony is attached. 
Responses to your specific questions follow: 
1. Analysis of the key provisions of the H.R. 11192 and S1713. The 
Administration prefers H.R. 11192 for the reasons stated in the Omenn 
testimony of April 11. The kev provisions are the authority to waive 
regulation of much work which is judged to bear minimal risk: the 
authority to carry out potentially “high-risk” experiments in order to 
assess actual risks; and the mechanism for uniform national standards 
and regulations, with a means for local appeal to the Secretary of 
[Appendix B — 338] 
