DC 
quate. (See attachment E.) Because of my concerns over the possible 
application of section 361, 1 wrote to the Secretary of HEW on May 4, 
1978, asking for his views on the scope and nature of authority in- 
cluded under section 361. (See attachment F.) The Secretary's formal 
response has yet to be received. 
In response to a similar inquiry, the Director of OSTP acknowl- 
edged that use of section 361 to regulate recombinant DXA research 
could create problems because (1) it acknowledges a significant risk 
of transmission of communicable disease, (2) it creates precedent for 
broad intrusions into the research environment, and (3) it does not 
apply to hazards to the environment that have no etfect on human 
health. (See attachment G.) 
At the very least, application of section 361 to recombinant DXA 
research would be subject to legal challenge. Section 361 has been 
employed in the past exclusively to regulate known human disease 
organisms, as well as known carriers of these organisms. There is no 
legal precedent supporting the application of section 361 to purely 
hypothetical risks. Given the complexity of the issue, use of section 
361 is likely to generate litigation which would further cloud the 
status of legislative and administrative etforts. 
I am also concerned about the scope of regulatory authority granted 
to the Secretary of HEW under section 361. On its face, it would 
grant to the Secretary unbridled discretion to promulgate and en- 
force such regulations as he deems necessary, and to take other meas- 
ures necessary to carry out the regulations. There are no apparent 
restrictions in the law on the power of the Secretary nor are there 
procedural requirements that he must follow in implementing and en- 
forcing these standards. It is my fear that by encouraging action by 
the Secretary of HEW to regulate a form of basic scientific research 
under an unusually broad grant of authority without a specific and 
clear mandate, we could unwittingly be initiating a dangerous regu- 
latory precedent for all basic science and technology. It is especially 
unsettling that this broad discretion would be given to the Department 
of HEW, the largest and most bureaucratic regulatory entity in the 
world. Under these circumstances, I cannot agree with the conclusion 
implicit in the majority’s recommendation that it would be prefer- 
able to avoid legislation if the Secretary can be persuaded to act 
under section 361. 
There are numerous other deficiencies with the recommended use 
of section 361. Violations of section 361 would be punishable under 
section 368(a) of the PHSA by a fine of not more than $1,000 or by 
imprisonment for not more than 1 year. This is extraordinary punish- 
ment for violations of rules governing hypothetical and unproven 
risks. There is no sunset provision or other similar provision limiting 
the duration of any regulations or other action taken by the Secretary 
pursuant to section 361. There is no Federal preemptive authority 
under this section. The authority of the Secretary in relationship 
with other Federal laws would not be specified. It would not contain 
Administrative Procedure Act or Xational Environmental Policy 
Act waivers for initial promulgation of the XIH guidelines as regu- 
lations. Section 361 would not authorize the Secretary of HEW to 
waive regulatory requirements for activities that pose no significant 
risk to health or the environment. In view of all these deficiencies, the 
23 - 890—78 5 
[Appendix B — 314] 
