- 2 - 
The alternative options discussed in the EIS (Chapter ’/I) are (A) no action, 
(B) NIH prohibition of funding of all experiments with recombinant D.A, (C) develop- 
ment of different Guidelines, (D) no guidelines but NIH consideraticn of each project 
on an individual basis before funding, (E) general federal regulation of all such 
research. Notably absent are the options of federal monopoly over reccrr. :a~.nt I^'A 
activities (exam.ple: Nuclear weapons research and manufacture) and internaticnal 
monopoly utilizing multilaterally supervised sites (example; Recent initiatives 
toward supranational uranium fuel enrichment and reprocessing facilities). 
These latter choices appear certain to grow in public favor. Given the wide- 
spread publicity which followed the mysterioxis outbreak of "Legion fever" in Penn- 
sylvania, the first instance of disease which implicates recombinant organisms will 
probably result in the rapid imposition of general federal regulation. The next 
serious outbreak may well precipitate federal monopoly, and the next, international- 
ization, Detailed planning for the possible implementation of these likely steps 
should begin now, lest proliferation of techniques, apparatus, materials and knowhow 
make their later achievement extremely difficult. Early institution of arrangements 
congruent with the assumption of high hazard will avoid the possibilities of calam- 
itous health damage, political overreaction, and resultant expensive modification or 
scrapping of facilities adjudged no longer acceptable. If later research results 
warrant a reduction of stringency, such easing could be accomplished much more 
readily than could additional safeguards be backfitted on a widely deployed array 
of laboratories and commercial applicationsj should tightening prove necessary. 
Specific Hiatuses in the EIS . A complete and candid EIS should reflect the 
very considerable body o7 federal knowledge amassed in the regulation of radio- 
active materials, hazardous chemicals, and drugs. This knowledge was accum.ulated 
at substantial cost in human life and health. To ignore history is to invite its 
repetition, this time with self -replicating biological materials which are self- 
distributing, unfamiliar to organisms* resistance mechanisms, very diffic\J.t to 
monitor in the environment, and probably impossible to eradicate once they have 
proven their viability. 
Hopefully, the newly passed Toxic Substances Control Act will be promptly 
interpreted to apply to any initial laboratory creation or first industrial use 
of each novel recombinant. Unless this and a variety of other federal questions 
can be fully clarified, both the research practitioners of ENA recombination and 
would-be commercial users face gargantuan uncertainties regarding the regulatory 
outlook for the field. In my detailed critique of the Guidelines, fifteen areas 
of informational deficiency were identified in the form of questions to specific 
government agencies,^ In the public interest these bodies should be required to 
go on record in ansver to these queries, which involve very large implications 
for the economy, public health, agriculture, environmental quality, and national 
security. In summary form, they are as follows: 
--Vulnerability of investigators or their sponsoring institutions to damage 
suits and/or criminal prosecution as a result of injury or death traceable to 
D. DeNike, "The Menace of Unregulated Recombinant ENA Research," August 1976, 
pp, 5-6, Available from the author ($1), 
Appendix K — 173 
