To; Hon. Ray Thornton 
January 19, 1982 
Page 4 
1) The Final Plan ahd the Update state that "the vast majority of 
information relevant to recombinant DNA risk analysis has already come from 
research not primarily designed to provide information on risk" (emphasis 
added). The fact is that virtually none of this research was designed to 
provide risk information at all .Scientific experiment cannot generally be 
said to prove a proposition which is not part of the initial hypothesis or, 
more importantly, which does not contribute to the research design. What- 
ever the possibilities of this occurring fortuitously in a single experi- 
ment (and the probability is small), the likelihood is increasingly reduced 
as the number of experiments relied upon is multiplied. The researchers 
have not made the necessary observations, performed relevant alterations to 
the experimental conditions, collected pertinent data, analyzed the results 
from a risk perspective, etc. In ti\y opinion the quoted sentence does not 
represent good scientific practice; to base policy on such a procedure 
could lead to significant negative consequences for the public. 
2) The Final Plan and Update continue to proceed as if the only risks 
which are presented by r-DNA experimentation are scientific/physical/environ- 
mental/health ones. This is technocratic thinking in the extreme. Numerous 
commentators, myself included, have repeatedly over the past five years 
raised concerns about non-scientific risks. Yet the Update states "no risks 
of recombinant DNA research have been identified that are not inherent in the 
microbiological and biochemical methodology used in such research." What 
about risks of accidents, of human fallibility, or due to arrogance or careless- 
ness? For example, did the violation of the Guidelines at the University of 
California, San Diego, occur because personnel in Dr. Kennedy's lab cloned the 
wrong virus by mistake? What might be the consequences of other mistakes in 
the future? Or was that California incident due to sabotage, as was first 
suggested ( Science , Vol . 209, pp. 1101-2, 5 Sept. 1980)? What are the risks 
of sabotage (especially considering the often lax supervision of laboratory 
activities provided by IBCs and BSOs)? Or perhaps it was an intentional event 
( Science , Vol. 209, pp. 1494-95, 26 Sept. 1980)? Indeed, the risks of inten- 
tional "misuse" of this new technology of gene recombination are among the 
most important issues raised by the research, yet NIH refuses to acknowledge 
them, no less mount a program to assess and hopefully control them. 
The NIH should be considering a "Non-Scientific Aspects" to its Risk 
Assessment Program. This should involve the talents of social scientists 
(sociologists, anthropologists, psychologists, public policy analysts working 
on risk assessment) and humanists (especially ethicists). This would require 
research activities particularly designed to probe issues such as those above. 
None of the official r-DNA institutions have handled ethical and 
cultural issues well. This attitude is reflected in the OTA Report on Applied 
Genetics. The report's ten page chapter on risk (a rather slender treatment 
of the topic) contains only three sentences regarding ethical and moral concerns 
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