THE UNIVERSITY OF MICHIGAN 
LAW SCHOOL 
Hutchins Hall 
Ann Arson. Michioan asios 
January 29, 1982 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant DNA Activities 
National Institute of Health 
Building 31, Room 4A52 
Bethesda, Maryland 20205 
Dear Dr. Gartland: 
I would like to comment on the proposal of the Recombinant 
DNA Advisory Committee (RAC) to convert the current rDNA 
Guidelines to a voluntary code of standard practice and to 
eliminate prior approval by Institutional Biosafety Conmittees 
before experiments can be begun (or approval by NIH in other 
classes of experiments) . I have followed the rDNA controversy 
closely since its early days. The original Guidelines appeared 
to be an acceptable balance between total prohibition of such 
research and the desire of at least some in the scientific 
community to proceed at full speed. The Guidelines repre- 
sented a govemmentally imposed norm, with regulatory teeth 
consisting of the sanction of refusal or withdrawal of funding, 
that was taken seriously by those engaged in research. I 
strenuously object to the attempt by the RAC to downgrade the 
Guidelines to the status of a moral code. Let me state my 
objection in the form of four propositions. 
I . The risks inherent in rDNA research are neither completely 
understood nor can they be dismissed as trivial . 
The Report of the Working Group on Revision of the Guidelines^ 
while making a case for a scaling down of estimates of hazard 
with regard to certain assumptions regarding the "vinique danger" 
of rDNA research, concludes that "a particular subject of ex- 
periments may still pose some possibility of risk . . . the 
possibility for improving the virulence, host r^e, or surviva- 
bility of some pathogens does seem to exist." The Group asks 
how serious this risk is, suggesting that more risk assessment 
work is needed to confirm that these risks are real or not. 
Evidence that health and environment hazards of rDNA research 
are unfounded is still limited; the thrust toward dismantling 
the regulations seems to relate more to pressure to get on 
with the research in an exciting new scientific area, rather 
than to a rational assessment that new experiments on safety 
issues have resolved them favorably. The burden of proof 
as to safety should still be on the individual researcher, in 
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