2 
lines were promulgated. The excuse that the guidelines were urgently needed 
does not exist with respect to the revisions and the efforts of the NIH thus 
far constitute a failure to comply with NEPA. 
1. Necessity of preparing an Environmental Impact Statement 
First, a thorough environmental impact statement on the proposed revisions 
is clearly required by the law. An environmental assessment is insufficient. 
The revisions are both major and significant, and the direction of change will 
significantly increase the possibility of affecting health and the environment. 
The comprehensive lowering of containment standards, the exemptions, the possi- 
bility of exceptions to prohibited experiments, all contribute to an increased 
risk to health and the environment. The revisions will lead to a significant 
expansion of recombinant research in addition to reduced safeguards on the sev- 
eral hundred recombinant DNA research projects already underway in this coun- 
try. Moreover, the revisions will have worldwide impact on guidelines being 
used in Great Britain, the European continent, Japan, Israel, Australia, and 
likely even the USSR, because of the leading role the NIH has played in setting 
recombinant DNA research standards on a worldwide basis. 
Even a casual perusal of the CEQ Guidelines and HEW procedures governing 
NEPA compliance demonstrates the necessity of a full environmental impact 
statement for the proposed revisions. Both the CEQ Guidelines, 40 CFR §1500.5 
(a)(3), and the HEW General Administration Manual, Subsection 30-10-50 C.5., 
provide that modification or amendment of existing regulations, policies and 
programs are subject to NEPA requirements. In Dulles v. Volpe , 541 F.2d 442 
(4th Cir. 1976), the court held that expanded airport use required an environ- 
mental impact statement and discussed the legislative history of NEPA: 
The House Committee was concerned that unless agencies were somehow forced 
to consider environmental factors in their decision making, "bureaucratic 
inertia" would frustrate the policies of the Act [footnote omitted] . 
These expressions of legislative purpose and concern indicate that Con- 
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