186 A South Street 
Boston, MA 02111 
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January 20. J 9K 7 
COMMITTEE FOR RESPONSIBLE GENETICS 
91 
Advisory Board 
Nicholas Ashford. Ph.D. 
Heather Baird-Barney. M.S. 
Roy L. Barnes 
Jonathan Beckwith, Ph.D. 
Philip Bereano. J.D.' 
Eula Bingham, Ph.D. 
David Brower 
Liebe Cavalieri, Ph.D.' 
Joseph Collins. Ph.D. 
Donald Comb. Ph.D 
Barry Commoner. Ph.O. 
Molly Coye. M.D. 
David Ehrenfeld. Ph.D., M.D. 
Ernest Englander, Ph.D. 
Rich Engler 
Sam Epstein. Ph.D. 
Richard Falk, J.D. 
Ross Feldberg. Ph D. 
Marcus Feldman, Ph.D 
Cary Fowler 
Lois Gibbs 
Terri Goldberg' 
Richard Gdldstein. Ph.D. 
Stephen Jay Gould. Ph D. 
Colin Gracey' 
Eric Holtzman, Ph.D. 
Ruth Hubbard. Ph D.' 
Vernon Jensen 
Jonathan King, Ph.D.' 
Sheldon Krimsky, Ph D." 
Marc Lappe, Ph.D.' 
Marvin Legator, Ph.D. 
Bruce Levin, Ph.D. 
Richard Levins. Ph.D. 
Richard Lewontin, Ph.D 
Manning Marable. Ph.D. 
Anthony Mazzocchi' 
Everett Mendelsohn, Ph.D. 
Albert Meyerhoff, J.D. 
Claire Nader. Ph.D.' 
Stuart Newman, Ph D.' 
David Noble, Ph.D. 
Judy Norsigian 
Richard Novick, Ph.D. 
Christine Oliver. M.D. 
David Ozonoff, M.D. 
Scott Paradise 
David Pimentel. Ph.D. 
Bernard Rapoport 
Barbara Rosenberg, Ph.D.' 
Barbara Katz Rothman, Ph.D. 
Roger Shinn 
Victor Sidel, M.D. 
Helen Rodriguez -Trias, M.D. 
John Vandermeer, Ph.D 
George Wald. Ph.D. Nobei Laureate 
William Winpisinger 
Steve Wodka 
Sidney Wolfe, M.D. 
Susan Wright, Ph.D.' 
'Executive Council 
Nachama L. Wilker 
Executive Director 
Willliam A. Gar Hand 
Recombinant DNA Advisory Committee 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda. Maryland 20892 
Dear Dr. Gartland: 
On behalf of the Committee for Responsible Genetics (CRG), 1 would like 
to submit the following comments to the Federal Register notice of 
December 19. We will focus our comments primarily on items II and 
III, the proposed revision of Section III-A-2 of the NIH Guidelines and 
item IV. the proposed revisions of Appendices of C-II, C-III. and C-IV. 
1 ) The CRG supports leaving unchanged the definition of recombinant 
DNA and recommends citing each exemption to the definition within the 
guidelines. We do not see sufficient empirical justification within the 
scientific disciplines of the intrinsic safety of deletion mutants of 
microorganisms to warrant broad exemptions of these products of 
recombinant DNA from review by RAC. As an example of this, we refer 
the RAC to the comments of Robert Colwell et al. concerning the 
Coordinated Framework for Regulation of Biotechnology submitted to 
the Office of Science and Technology 1 Policy concerning the Federal 
Register notice of June 26, 1986 for a concise review of many of the 
questions raised within the scientific community. Dr. Colwell and his 
colleagues point out that: 
... Because regulatory regions in the genome serve to control the level of 
production of gene products, in some cases turning production on or off 
entirely, ecologically important aspects of phenotype, such as substrate 
utilization, can certainly be altered by changes in regulatory sequence 
In the same vein, deletion of regulatory sequences (e g the removal of a 
repressor, or of a promoter) clearly can also control gene expression : the 
deletion of an entire gene certainly does However "precisely 
constructed" an organism may be genetically, its ecological phenotype is 
not so easily predicted, and is nonetheless a matter for discovery and 
testing by careful experiments. 
2 1 Referring to proposed changes on section III-A-2 c of the guidelines, 
the CRG objects to the use of the criterion for exemption of laboratory 
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Recombinant DNA Research, Volume 1 1 
