72 Jane Street 
New York NY 10014 
(212) 675-7173 
1 
X 
Coalition for Responsible Genetic Research 
ADVISORY COUNCIL 
John S. Bird M.D. 
Dr. 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* 
Dr. Marvin Kalkstein* 
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. George Wald*, 
Nobel Laureate 
Susanna Waterman* 
Dr. Joseph Weizenbaum* 
Dr. Susan Wright* 
*£xecutive Committee 
MEMBERSHIP: 
PARTIAL LISTING 
Walter Askinas M.D. 
David R. Brower 
Rev. Roger Burgess 
Sir MacFarlane Burnet, 
Nobel Laureate 
Stuart Chase 
Citizens Rights Committee 
Glen 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. Golomb 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. Origenes 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 Garb M.D. 
Membership Secretary 
July 29, 1981 
Dr. William Gartland 
ORDA 
National Institutes of Health 
Bethesda, Md. 20014 
Deat Df; Gartland: 
Our organization herewith submits comments on the Baltimore/ 
Campbell proposal to downgrade the Recombinant DNA Guidelines from 
regulation to a recommended code of practice . Recent broad exemp- 
tions and elimination of prdhlbl felons in recommended DNA research 
by the NIH make it especially impelling to maintain the guidelines 
as regulations . 
The Baltlmore/Campbell proposal would remove those mechanisms 
essential to the enforcement of the guidelines. Given the intensely 
competitive nature of the research and its development, this proposal 
would facilitate lower safety standards and less careful procedures. 
For some individuals and groups, regulation alone acts as a deterrent. 
Under the Guidelines as regulation, the existence of Institution- 
al Biosafety Committees is required with these committees responsible 
to the NIH. The IBC’s exercise a measure of control over over the ad- 
equacy of safety procedures and the detection of hazards. They func- 
tion, as well, as boards for the consideration of scientifically inad- 
equate or improperly-conducted research. Linkage of IBC's with the 
NIH is of prime importance in maintenance of standards. 
Industry has been complying with the NIH regulations voluntarily. 
Should "recommended standards" be substituted for the regulations, it 
is quite likely that industrial compliance will become meaningless: 
competitive pressures may well activate industry to take advantage of 
unregulated shortcuts to large-scale production. Historically, indus- 
trial self -policing has not been successful. 
There are still many unanswered questions for this emerging tech- 
nology (new host-vector systems, exchange of genetic material in the 
environment, etc.). Non-mandatory standards might convey a sense of 
"safeness" that would tend to close off the issue of potential risks. 
The optimum course of action should reasonably include risk assessment 
experimentation to keep pace with recombinant DNA research and develop- 
ment. 
Further reason for mandatory Guidelines is the question of uniform- 
ity. Voluntary standards would be adopted as "required" by some Instl- 
Francine R. Simring 
Executive Director 
[ 598 ] 
