80 
DHEW. S1713 does not meet these needs as well as H.R. 11192 seems 
to do. 
2. Do we agree with the conclusion of the Federal Interagency 
Committee on Recombinant DXA Research (March. 1977) that no 
present authority is sufficient to deal with recombinant DXA tech- 
niques in every regard? Yes. As we discussed in detail before your Sub- 
committee on Xovember 8. only Section 361 of the Public Health Act 
has the potential to meet this broad mandate. However. 361 does not 
meet every aspect of the situation, as will be explained in the next 
few questions. 
3. Could Section 361 be used to cover the private sector? Yes. 
4. "What problems might arise from use of Section 361 to regulate 
recombinant DXA research? One concern often raised is the notion 
that invoking Section 361 would seem to some to acknowledge a sig- 
nificant risk of transmission of communicable disease. Present evidence 
makes such risks strictly conjectural. Section 361. of course, was not 
written to regulate research. Its use in this regard may provide prece- 
dent for broad intrusions into the research environment, with Con- 
gressional debate. Section 361 does not deal with hazards to the en- 
vironment that can be shown to have no primary or secondary effect 
on human health. 
5. What are the authorities of the Secretary under Section 361 ? 
For a comprehensive analysis, you should inquire of the General 
Counsel at DHEW. Probably you have done so already. Our own 
review suggests that Section 36i. together with Section 368, provides 
broad statutory authority for the development of detailed regulations 
for essentially all of the functions you name. 
6. Compare the authority of the Secretary under Section 361 with 
that under the currently proposed legislation. In the absence of de- 
tailed analysis from DHEW on Section 361, such a comparison is not 
feasible. Certainly, authorities would be far more explicit under the 
sjDecific bills than under Section 361. 
7. Does the Secretary have authority under Section 361 to preempt 
State and local actions concerning recombinant DXA research and 
related activities? The Secretary apparently would not have the au- 
thority to preclude State or local actions more stringent than the 
national standards or regulations. 
I hope that these responses are helpful to you in the current delib- 
erations. 
Yours sincerely, 
Frank Press, Director. 
[Appendix B — 339] 
