EIS while the Guidelines were being drafted; drafting began 
in February of 1975 and was completed in February of 1976. 
NIH is not exempt from strict compliance with the 
procedural requirements of §102(2) (C) of the National Environmental 
Policy Act. The process of drafting and reviewing the Guidelines 
does not bring NIH within the narrow exception for agency actions 
based on review procedures which substantially comply with NEPA. 
This exception has been defined in a number of cases challenging 
actions taken by the Environmental Protection Administration 
under statutes designed to protect the environment. Environmental 
Defense Fund v. EPA, 489 F2d 427 (D.C. Cir. 1973); P ortland 
Cement Ass ' n v. Ruckleshaus , 486 F2d 375 (D.C. Cir. 1973) . 
The exception has only been applied to EPA, because it is an 
environmental protection agency, when it is acting to protect 
the environment and its action was preceded by full environmental 
review including public participation equivalent to what is 
required under NEPA. NIH is not an environmental protection 
agency; its purpose is to promote scientific research. Whatever 
environmental review was conducted as the Guidelines were 
being drafted would have been colored by NIH's primary purpose 
of promoting research. Without the environmental impact statement, 
we cannot be sure that the environmental impacts of the 
Guidelines and alternatives were properly considered. Also NIH 
did not provide an adequate opportunity for public participation. 
Under the procedures followed by NIH, the general public had 
no opportunity to participate in the promulgation of the 
6 
Appendix K — 132 
