The Public Health Research Institute 
OF THE City of New York, Inc. 
ABS FIRST Avenue, new York, N. Y. 10016 
Tei.. (212) 481- 
January 11 , 1982 
Dr. William ,J. Gartland, Jr. 
Dept, of Health & Human Services 
Public Health Service 
National Institutes of Health 
Bethesda, MD 20205 
Dear Bi 1 1 : 
This is in response to the alternative proposals currently under 
consideration for revision of the NIH Guidelines for Recombinant DNA 
Research. To put it very simply, I feel that the Bal timore-Campbel 1 
proposal to eliminate all mandatory aspects of the Guidelines and re- 
place them with a voluntary code of practices is premature. I offer 
the following ideas in support of this posittioh; 
1) I agree that the chance of a significantly hazardous accident 
arising during any shotgun cloning experiment is sufficiently small to 
justify reduction to PI containment of all such experiments, regardless 
of host, vector, etc. 
2) Nevertheless, I am not sufficiently reassured regarding the 
possibility of hazardous outcomes in certain specific experiments to be 
willing to eliminate all mandatory controls. These experiments are the 
following: a) cloning experiments that are likely to result in the pro- 
duction of infectious pathogenic virusus (I note that it has recently 
been found that a cDNA copy of the poliovirus genome gives rise to infec- 
tious vfrus.es upon introduction into mammalian cells (Racaniello and Bal- 
timore, Science 214:916, 1981). b) The deliberate introduction of or- 
ganisms containing cloned DNA into the environment. The ecological 
impact of unknown organisms in new habitats has so often been disastrous 
that I would not want to see this being done without at least the oppor- 
tunity for public review and approval beforehand, c) The introduction 
of antibiotic resistance genes into organisms that do not naturally 
harbor such genes, where there is a possibility of therapeutic compromise 
as a consequence, d) Cloning experiments with toxins as described in 
appendix G of the extant Guidelines should continue to be regulated 
(I do not agree entirely with the provisions of appendix G, but that is 
another matter). 
I feel that it is appropriate to point out here that it is probably 
incorrect to regard £. col i K12 as absolutely innocuous. On the one hand, 
it has been shown that K12 is capable of colonizing the mammalian gut 
under special circumstances (note that most wild strains of £. coli will 
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