40 
thanks. However, the primary role of these hearings, and of the Guidelines 
themselves, is to safeguard the population and the ecosystem from avoidable 
harm, and it is to the performance of this charge that our attention must be 
turned 
Now, applications of recombinant DNA technology are rapidly and continu- 
ously proliferating. More and more DNA sequences from an increasing variety 
of organisms are being introduced into bacteria, new vectors are being de- 
veloped, new hosts are being introduced, more and more institutions are sites 
of this activity. As the generation of hybrid organisms proliferates, so will 
the potential hazards. The gap between the construction of chimeric E. coli 
strains and their commercial exploitation is rapidly decreasing, as is evident 
from the article in the current edition of Business Week on somatostatin, 
which talks about the rapid movement of this into production. 
Note that the potential hazard of rapidly introducing altered organ- 
isms into the environment differs from that associated with the introduction 
of new chemicals. Chemicals are not self-reproducing. If by accident, 
oversight, ignorance, or negligence chimeric organisms do reach the en- 
vironment and prove deleterious, they cannot be cleaned up. Stopping their 
production will not necessarily stop their spread or reproduction in the 
ecosystem. It is precisely because of this potentially irreversible char- 
acter that many of us have been singularly concerned about this technology, 
in which the altered agents can reproduce themselves. 
I should say in general my own source of concern over health hazards 
is not on the conversion of E. coli K-12 to a pathogen, but to the trans- 
fer of foreign DNA sequences into wild strains of E. coli which are already 
adapted to some particular niche in the ecosystem, whether the intestinal 
tract of chickens, the urinary tract of human females, or disposal sites 
labeled Clean Land Fill. I note that hospital-acquired E. coli infections 
are an increasing health problem in the United States, and they are gen- 
erally associated with antibiotic-resistant plasmids. 
Now, I will identify what I consider some major problems and inadequa- 
cies in the draft Guidelines, and propose changes. I am concentrating on 
deficiencies, not to deny the presence of major improvements, such as the re- 
quirement of a professional biohazards officer, recognition of the animal 
facilities problem, the hint of dealing with the antibody-resistance problems 
But the major problems are: One, the information base on which the Guidelines 
are drawn are inadequate. In the drawing up of criteria documents, for 
example, levels of uranium dust exposure to miners, Federal agencies usually 
first gather all the available information and they publish it. They put out 
a call, any of you out there who think you know about it, even though we may 
not know of your existence, please come to our meeting. 
The data base should be presented in summary form at the beginning 
of the draft Guidelines. These summaries should include at a minimum the 
general incidence and target organs, urinary tract, gastrointestinal tract, 
kidney, of E. coli infections in the United States. 
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