Residential College 
East Quadrangle 
The University of Michigan 
Ann Arbor, Michigan 48109 
(313)763-0176 
January 30, 1984 
Dr. James B. Wyngaarden, M.D. 
National Institutes of Health 
9000 Rockville Pike, 124 NIH 1 
Bethesda, Maryland 20814 
Dear Dr. Wyngaarden: 
I am writing in response to the announcement of several actions to be 
considered by the Recombinant DNA Advisory Committee at its next meeting on 
February 6th and 7th. 
These actions were published in the Federal Register on January 5th, 
but it appears that the notice was not sent out to those on the mailing list 
of the Office of Recombinant DNA Activities until last week. I received the 
notice from ORDA on Friday, January 27th; others with whom I checked also 
received the notice in the latter half of last week. This leaves a week to 
send comments to ORDA and effectively no time for committee members to respond. 
I note that at least four of the actions listed are major policy items: 
1. A proposal to require publication of an environmental impact statement 
or environmental impact assessment for procedures involving release of 
organisms containing recombinant DNA into the environment. 
2. Questions concerning the boundaries for NIH oversight of recombinant DNA 
activities . 
A decision to apply the NTH Guidelines only to work funded by the Federal 
Government will mean that there will be no oversight of work in the private 
sector . 
3. A proposal from a military agency to clone the gene for shiga-like toxin 
in E. coli K-12 at P2 containment. 
A' decision to approve this proposal will generate an important precedent 
for work with the genes for the most potent toxins. No risk assessment experiments 
have been carried out on the safety of cloning the genes for sue- substances, 
and expert opinion is divided on this matter. Thus a decision to approve this 
experiment at P2 will pave the way for further decisions in advance of any direct 
experimental evidence on the hazards of such work. Furthermore, such a decision 
will make it possible for large-scale production of potent toxins to proceed 
without oversight by any government agency and without public knowledge. 
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