In view of the hazards posed by the new recombinant DNA technology to both 
humanity and the environment, any formulation of policy dealing with this research 
must consider the mandates of the National Environmental Policy Act (NEPA) . The 
National Institutes of Health should be credited with their issuance of the 
"Draft Environmental Impact Statement" concerning the "Guidelines for Research 
Involving Recombinant DNA Molecules". However, the timing of the release of the Draft 
EIS, three months following the release of the "Guidelines", precludes any possibility 
for unbiased environmental policy review of the "Guidelines". The desire by the NIH 
to_ formulate and release a set of guidelines for this research as soon as possible 
does not explain or excuse their failure to act in accord with NEPA directives. 
The NIH "Draft Environmental Impact Statement" is no less than a violation of both 
the spirit and the letter of the National Environmental Policy Act. 
In summary: (1) The NIH has failed to "initiate and utilize ecological information" 
(NEPA §102 (H)) concerning the dangers of Escherichia coli as a host in recombinant DNA 
work. This failure renders any serious discussion of the monitoring and control of 
pathogenic recombinant organisms intractable at this time. (2) No significant attempts 
have been made to "recognize the worldwide and long-range character of environmental 
problems" (NEPA §102 (F)) that may arise from NIH-supported research. The Draft EIS 
ignores industry's current widespread use of recombinant techniques developed through 
NIH-funded projects. (3) No attempts to "study, develop, and describe appropriate 
alternatives" (NEPA §102 (E)) to the recombinant DNA technology itself have been construed. 
The Draft EIS ignores the development of alternative ^ vitro techniques for the 
cloning and amplification of the genetic material concurrent with the development of the 
recombinant DNA technology. (4) A "systematic, interdisciplinary approach" (NEPA 
§102 (A)) was not employed in the formulation of both the "Guidelines" and the Draft 
EIS. The impact statement provides little evidence of input from groups outside the 
genetics research community, such as input from those directly involved with community 
health. 
The NEPA describes as its purpose to "enrich the understanding of the ecological 
systems and natural resources important to the Nation" (NEPA §2) . Through the NEPA, 
the Congress directs the fullest extent possible all Federal agencies to "initiate 
and utilize ecological information in the planning and development of resource-oriented 
projects" (NEPA § 102(H)). A further understanding of the ecology of coli and its 
plasmids is requisite to an assessment of the hazards of this research. Such an 
understanding can be gained only through active research concerning (a) conditions 
under which plasmids spread within and among species in the biosphere, (b) the ability 
of foreign DNA-containing plasmids to establish and maintain themselves at significant 
levels in naturally occurring bacterial populations, and (c) the survival capabilities 
of plasmids conferring little or no "survival advantage" to naturally occurring hosts. 
In the part of the Draft EIS entitled "The effect of foreign DNA on the survival of 
recipient species" no evidence for the claim that foreign DNA reduces survival 
capabilities of foreign DNA-containing plasmids is given beyond vague selectionist 
platitudes. Unpublished results from the laboratory of Dr. Bruce Levin at the University 
of Massachusetts in Amherst argue contrary to the implications of this claim. Rising 
I health concerns over drug and antibiotic resistance factors should also temper such 
I claims with the requirement for evidence in their support. In addition, Dr.^Ron Davis 
I has demonstrated that coli can be altered phenotypically from his to his by the 
insertion of a plasmid carrying shotgunned yeast genes (1) . This finding seriously 
challenges the rationale of construction and maintenance of EK2 or other weakened hosts, 
in that defects in weakened strains may be corrected by plasmid-carried genetic information. 
Appendix K — 168 
