The administrative regulations to be promulgated unde? this sub- 
section are exempted ftQm the provisions of section , 55$ , of title, 5, 
United States Code, the Administrative Procedure Act. They are 
to take effect upon their publication in' the Federal Register., t 
This method of rulemaking was chosen iso as to establish adminis- 
trative regulations as soon as possible after enactment, without the 
lengthy procedures involved in the promulgation* of; regulations ac- 
cording to' the provisions of the Administrative Procedure Act. It is 
generally considered that Since the administrative regulations per se 
do not deal with a potential hazard to < health or the environment, 
there would be no perversion of the intent of the law to waive the 
Administrative Procedure Act. However, since - the committee recog- 
nizes that there could well be public concern over even administrative 
regulations, the Secretary shall provide interested persons* with ; an 
opportunity to present written comments, and may also provide an 
opportunity for the oral presentation of views and arguments. After 
consideration of the comments so received, the Secretary may by order 
make appropriate revisions in the regulations. 
APPLICABILITY OF THE NATIONAL ENVIRONMENTAL POLICY; ACT OF 1969, 
During its consideration of H.R. 11192, the committee deleted sub- 
section 102(e) which provided that the National Environmental Pol- 
icy Act of 1969 (NEPA) shall not apply to any action under tifle I 
of the bill. The committee believes such a statutory exemption from 
NEPA is both unnecessary and an unwise precedent. The elimination 
of subsection (e), furthermore, will not adversely affect the basic 
thrust of the proposed legislation — prompt application of. the present" 
NIH guidelines to non-NIH grantees, 
Subsections 102(a) (1) (Ay and (B) of the bill will' make the sec- 
tions II and III of the Guidelines initially applicable to all persons 
by operation of law, not through a fulepnaking process by in admin- 
istrative agency. NEPA’s Requirements, however, are applicable only 
to actions of Federal administrative agenCiCs, and not to the Congress. 
Hence, NEPA would be inapplicable to the' requirements of these sub- 
sections, i.e. the application of the guidelines either as they were pub- 
lished on July 7, 1976, or any revision thereof made prior to the 10th 
day after the date of enactment of this bill. 
Moreover, under the . Supreme Courts ruling in Flint Ridge Devel- 
opment Co. v. Scenic Rivers Association of Oklahoma, 426 U:S. 776 
(1976), the requirements of NEPA could not Serve to delay the issu-< 
ance, under section 102(d) of the bill, of the' regulations for the ad- 
ministration of the requirements made by section. 102. In its Flint 
Ridge decision, the Supreme Court ruled that the mandatory limita- 
tion of .30 days imposed by the Interstate Land Sales Disclosure Act 
(ILSpA)r was inconsistent with the NEPA’s requirement of an envi- 
ronmental impact statement (EIS). because, an EIS could not possibly 
be accomplished within 30 days; and hence made NEPA’s EtS re- 
quirement inapplicable to the actions prescribed bv the ILSDA. Sub^ 
sectiop 102 ( d) of the committee bill requires the 'Secretary to promul- 
gate effective administrative regulations within, thef 90-day period 
beginning on the date of enactment of this - bill. Under tici&Flint Ridge 
decision, these initial administrative regulations may not be delayed 
[Appendix B — 149] 
