54 
ing to the use of section 361 to regulate recombinant DXA research, 
they nonetheless recommend, that the Secretary of HEW “give the 
most serious consideration” to promulgating standards under section 
361 if the legislative committees conclude the existing authority is ade- 
quate. The majority report also suggests that the Secretary prepare 
for the use of section 361. 
The effect of these statements, in my view, is to give unj ustified and 
ill-advised support to the use of section 361 to regulate recombinant 
DNA research in lieu of legislation. At this time, 1 am opposed to any 
language in the report that might suggest that the subcommittee con- 
siders section 361 to be appropriate for regulation of recombinant 
DXA research. 
The majority's recommendations regarding section 361 are some- 
what surprising inasmuch as the applicability of that statutory au- 
thority to recombinant DNA research was not a subject of the hear- 
ings held by the subcommittee. The only reference to that section 
during the entire course of the hearings on recombinant DNA research 
was made by Dr. Gilbert Omenn of the Office of Science and Technol- 
ogy Policy. Dr. Omenn expressed the opinion that regulation by in- 
voking a law designed to protect against contagion would amount to 
overkill. There is no support in the hearing record for application 
of section 361 of the PHSA to recombinant DNA research. 
The majority apparently has been persuaded by subsequently ac- 
quired evidence that application of section 361 would be appropriate. 
I am not so convinced. In fact, information presently available indi- 
cates many problems associated with use of this section to control 
recombinant DNA research. 
As the majority report acknowledges, section 361 refers only to 
“communicable diseases” affecting human beings. Its application to 
plants, animals, or the general environment is questionable at best. 
Clearly, section 361 was not intended by Congress to apply to basic 
scientific research activities such as with recombinant DNA. Support 
for this conclusion can be found in the report of the Federal Inter- 
agency Committee on Recombinant DNA Research and a response 
from the Congressional Research Service (CRS) , both of which agree 
that “no single legal authority or combination of authorities currently 
exist that would clearly reach all research and other uses of re- 
combinant DNA techniques and meet all the requirements.” (See at- 
tachment D. ) 
Moreover, there is some question as to the application of section 
361 to activities of a purely intrastate character. The most recent 
court decision construing section 361 ruled that the scope of this sec- 
tion extends to intrastate activity where necessary to prevent the 
interstate spread of disease. ( State of Louisiana v. Mathews , 42T F. 
Supp. 174 (1977)). With reference to DNA research, there is no evi- 
dence to support the position that intrastate regulation is necessary 
to prevent the interstate spread of communicable disease. Any hazards 
arising from recombinant DNA research are at this time purely specu- 
lative and highly unlikely. 
The Department of HEW has stated on several occasions that it 
prefers legislation, and that the use of section 361 to regulate re- 
combinant DNA activities would be both inappropriate and inade- 
[ Appendix B — 313] 
