'?. Jan... Street 
New York N Y 10014 A 
(212) 675-71 73 /A 
Coalition for Responsible Genetic Research 
ADVISORY COUNCIL 
John S. Bird M.D. 
Or. Irwin Bross 
Helen Caldicott M.D.* 
Dr. Liebe Cavalieri* 
John C. Cobb M.D * 
Dr. Douglas DeNike 
Dr. Key Dismukes* 
W. Jack Frumin M.D. 
Solomon Garb M.D.* 
Steven Havas M.D .* 
Dr. Ruth Hubbard’ 
Di. Marvin Kaikstein’ 
J.R. Kent M.D. 
Dr. Jonathan King’ 
Dr. Sheldon Krimsky* 
Elliot Linzer’ 
Pamela Lippe* 
Joyce Milton 
Lewis Mumford * 
Dr. Stuart Newman* 
Christine Oliver M.D.' 
David Ozonoff M.D * 
Dr. Barbara Rosenberg* 
David Straton M.D.* 
Dr. Ceorge Wald*, 
Nobel Laureate 
Susanna Waterman* 
Dr. Joseph Weizenbaum* 
Dr. Susan Wright’ 
* Executive Committee 
MEMBERSHIP: 
PARTIAL LISTING 
Walter Askinas M.D. 
David R. Brower 
Rev. Roger Burgess 
Sir MacFarlane Burnet, 
Nobel Laureate 
Stuart Chase 
Citizens Rights Committee 
Clen C. Cobb M.D. 
Dr. C. David Elm 
William D. Furst M.D. 
Reverend David A. Furuness 
Mariano L Galaineva M.D. 
W.B. Gamble Jr. M.D. 
F.M. Colomb M.D 
Dr. Mario A. Gonzalez 
Harold J. Harris M D. 
Dr. Kenneth L. Jackson 
Father Walter T. Kelleher 
Hadley Kirkman M.D 
Dr. Laura Kratz 
Henry D. Lauson M.D. 
Dr. Herbert Manning 
Edwin F. Matthews Jr. 
Edward Miller M D. 
Robert Murphy M.D. 
Maurice L. Ongenes M.D. 
Dr. Aurelio Peccei 
Henry Pinkerton M D. 
Eliot Porter 
Dr. Jerome Prager 
Dr. Steven Price 
Sister Mary E. Reichert 
Abby Rockefeller 
Lewis M. Schiffer M.D. 
Solomon Carb M.D. 
Membership Secretary 
Francine R. Simring 
Executive Director 
January 21, 1980 
The Honorable Patricia Roberts Harris 
Secretary 
Department of Health, Education and Welfare 
Washington, D.C. 20201 
Dear Secretary Harris: 
Responding to the request for comment on large-scale recom- 
binant DNA projects, we wish to register the following points: 
1. The. upper limit of IQ liters of culture of recombinant 
DNA organisms has prevailed in NTH Recombinant DNA 
Guidelines since June 23, 1976.. Great pressure for 
exemptions from this limit is being brought to bear by 
those whose interest lies mainly in the industrial 
application of this controversial technology. 
2., Recent NTH" risk assessment experimentation indicates 
greater hazard than previously thought: 
a., recombinant DNA molecules survive for four 
days in sewage and the human gut-*- 
h., naked polyoma DNA can cause, infection in 
sterile mica^ 
c. gene-splice products, can cause tumors in 
experimental animals^ 
3.’ Risk assessment of large-scale projects has not been 
pursued although industrial scale-up would involve 
volume-oriented production of recombinants carrying 
hormones (Insulin, somatostatin, etg.) and other human 
substances (e.g. interferonF. The impact on human and 
other populations is not known (i.e. anaphylaxis, auto- 
immune diseases, etc.) and investigation has yet to be 
initiated . 
■— ) A. Expanding the volume of production sharply increases 
the chance for biologic mishap. 
S, 
V Before exemptions from- the 10 liter limit can be considered, exper- 
'(£) imentation to assess the risks of large-scale production must be 
fj! 
1. S. Levy and B. Marshall, "Survival of E. coli Host-Vector Systems 
z=i in the Human Intestinal Tract", Recombinant DNA Bulletin 2/7 /79 
A 2 . B. Rosenberg and L» Simon, "Recombinant DNA:Have Recent Experi- 
K ments Assessed All the Risks?", NATURE, 282, December 20-7, 1979. 
3. "Molecular Cloning of Polyoma Virus DNA in Escherichia coli; Onco- 
genicity Testing in Hamsters", SCIENCE, 205, March 2, 1979. 
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