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carried out. Such investigation needs, at minimum, to include the 
following : 
1. assessment of the disposal of large quantities of recombinant 
organisms into effluent systems 
2. pharmacologically-active proteins produced by gene-splicing 
in large quantities should be adequately pre-tested for 
effects on humans and the environment. 
3. experimentation to include anaerobic bacteria and wild strains 
of E. coli. 
If the data derived from these investigations indicate that, with 
specified safeguards, it would not be premature to proceed, then the 
following should be included among those requirements for projects 
exceeding the 10 liter limit: 
1. sufficient evidence to demonstrate that the subjects 
for cloning would not be harmful 
2. prohibition of release of recombinant organisms into 
the environment (drains, effluent, waste, etc.) without 
meticulous testing to ensure that all organisms are 
inactivated 
3 . ongoing health surveillance and maintenance of health records 
of employees 
It seems to us patently clear that protection of the public health requires 
that industry comply with NIH regulations. Historically, industrial self- 
policing has never worked. It is not likely that there is any reason to 
suspect a change in this area, nor can we permit ourselves the luxury of ex- 
perimentation with voluntary compliance; the technology of recombinant DNA 
does not allow much margin for error. We wish, therefore, to underline our 
unequivocal support for reqaired compliance with regulation by industry, 
which was voted for by the NIH Recombinant DNA Advisory Committee. 5 
We need to keep in mind the tragic failures of the nuclear energy industry: 
only by open, full disclosure of facts and data, regulation of public and 
private sectors, and a cautious approach will we be able to avoid a biological 
Three Mile Island, 
Reducing laboratory containment standards and permitting exemptions without 
supporting data constitute neither a cautious nor a scientific approach. We 
hope that your tenure- in office will be marked by a change from current NIH 
philosophy and practice to one of caution that would be more appropriate to 
an agency whose "mission is to improve the health of the American people".^ 
FRS :fh 
4 . U . S . Government 
Organizational Manual 
Yours very truly, 
Francine Robinson 
Executive Director 
5, S, Krimsky and D. Ozonoff , "Recombinant DNA: Scope and Limits of Regulation", 
American Journal of Public Health, December 1979. 
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