65 
The Library of Coxgress, 
CoXGRESSIOXAi, RESEARCH SERVICE, 
Washington. D.C.. May 12, 1928. 
To : Hon. Harrison H. Schmitt. 
From: American Law Division. 
Subject: Questions concerning the applicability of section 361 of the 
Public Health Service Act to recombinant DXA research. 
The following memorandum has been prepared in response to your 
several questions regarding HEW’s regulatory authority under Sec- 
tion 361 of the Public Health Service Act (42 LhS.C. § 264). Speci- 
fically, you have requested our opinion as to the regulatory scope of 
Section 361 andits applicability topublic and private recombinant 
DXA research. 
Initially, we must agree, based on our own extensive research, with 
the Federal Interagency Committee on Recombinant DXA Research 
that “no single legal authority or combination of authorities currently 
exist that would clearly reach all research and other uses of recombi- 
nant DXA techniques and meet all the requirements/’ In a paper we 
prepared last December, we came to the same conclusion : 
In brief, comprehensive regulation of the products result- 
ing from recombinant DXA research techniques does not ap- 
pear feasible under current laws. At best, regulation will be 
piecemeal and dependent on the uses for which those products 
are intended. Regulation will be dispersed throughout several 
federal agencies, where the research activities involved come 
under the respective department or agency mandate and it 
will be limited by the purposes enumerated in the appropriate 
authorizing legislation. 
Several of your questions deal with Section 361 (42 U.S.C. § 264). 
While it can certainly be argued that section 361 does authorize the 
Secretary of HEW to promulgate regulations to protect the public 
from the introduction or spread of any suspect communicable disease, 
thus authorizing the regulation of recombinant DXA research, it is a 
highly disputed interpretation of the section. The section, on its face, 
refers to the prevention of the spread, etc. of communicable diseases. 
Admittedly the language of Section 361 ( a ) is rather broad. However, 
specific statutory limitations in subsections (b), (c) and (d) to “dis- 
eases as may be specified” and to the control of interstate and foreign 
travel of infected persons, suggest that control of private intrastate 
research to assure protection of the public and environment from un- 
known dangers and unspecified diseases may well be outside the scope 
of the section. It can hardly be argued that Congress intended, when 
the original quarantine law was enacted, * 1 or superceded, that this regu- 
latory authority extended to research which is just now becoming feas- 
ible. While there is no doubt that Congress intended the appropriate 
federal authorities to have broad and flexible powers (i.e. “the use of 
conventional public-health enforcement methods”) 1 to prevent the 
spread of dangerous and destructive disease, it surely did not mean 
that scientific research was to be pervasively regulated. 
1 Originally enacted In 1S79 (Act of Mar. 3, 1S79), superseded in 1S93 (27 Stat. 449), 
and in 1944 (58 Stat. 703.1. 
1 This language is from the House report accompanying the 1944 amendments. 
[Appendix B — 324] 
