34 
preparation of either an envirormental impact statement or an 
environmental assessment." 
In explanation of this proposed change, Messrs. Rifkin and Rogers stated: 
"Where it is uncertain vhether a particular experiment may or may not 
have a significant impact on the environment, then, at the least, an 
environmental assessment (EA) must be prepared explaining the conclusion 
reached on the question of significant impact, and the relevant environ- 
mental agencies must be involved in that assessment process. See CEQ 
Regs. §§1501.3, 1501.4, and 1508.9. At issue here are the great variety 
of deliberate release experiments that have potential environmental 
impacts." 
Dr. Krause, the Director of the National Institute of Allergy and Infectious 
Diseases (NIAID) , carmen ted in the January 5, 1984, Federal Register on 
the proposed amendments. Dr. Krause said: 
"The NIH Recaribinant DNA Advisory Committee (RAC) does not have the 
responsibility to determine, and it is not appropriate for the NIH 
Guidelines for Recaribinant DNA Research to state, vhat is, or is not, 
required by the National Envirormental Policy Act (NEPA) (42 U.S.C. 
4321 et seq.) and the regulations (40 CFR Part 1500) promulgated by 
the Council on Envirormental Quality (CEQ) to assure the uniform 
implementation of that Act. It is not the function of the RAC to 
determine vhat NEPA and the CEQ regulations require. The RAC is not 
constituted to interpret points of law and the requirements of NEPA. 
Specifically, it is not a function of RAC to determine when an 
envirormental assessment is required by NEPA. 
"Furthermore, the Foundation on Economics Trends, Jeremy Rifkin, Michael 
W. Pox, Environmental Action, Inc., and the Environmental Thsk Force 
have raised these issues in a lawsuit against the Department of Health 
and Human Services, the National Institutes of Health, and the National 
Institute of Allergy and Infectious Diseases. The suit (Civil Action 
No. 83-2714) seeks to have the United States District Court for the 
District of Columbia decide if additional envirormental review is 
required by NEPA and the CEQ guidelines with respect to the procedures 
in the Guidelines for NIH approval of releases into the environment of 
organisms containing recombinant DNA and specific approvals given under 
those procedures. The decision of the District Court, or a higher 
court if an appeal is taken, will be binding on all the parties. 
"It should also be noted that a proposal similar to that now proposed by 
Messrs. Rifkin and Rogers was considered and rejected by the Director, 
NIH, at the time of the revision of the NIH Guidelines in December 1978. 
NIH Director Donald Fredrickson wrote in the Federal Register (43 FR 
60083, Decorber 22, 1978), 'Another commentator urged that for waiver 
of the prohibition of deliberate release into the environment, the 
Guidelines explicitly require compliance with the tfeitional Environmental 
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