Statement of the Honorable Douglas M. Costle 
Administrator, Environmental Protection Agency 
in the matter of: the Proposed Guidelines for the 
Conduct of Research Using Recombinant DNA — September 15, 1978 
Secretary Califano, Assistant Secretary Richmond, distinguished 
panelists--I am pleased to be able to submit this statement on the 
potential effects of research using recombinant DNA as it may impact 
on the environment. This opportunity for me and for other interested 
persons to inform you of our views is most welcome. While it is 
evident that the proposed revised guidelines on recombinant DNA 
research demonstrate that you are fully conscious of the enormous 
potential made possible by the use of recombinant DNA, they must also 
focus on control procedures to protect the lives and health of 
people and the environment from inadvertent effects of this new 
research procedure. The guidelines as originally proposed and now 
revised, have been carefully studied by a special subcommittee of the 
Environmental Protection Agency's Science Advisory Board, and In 
addition by scientists within EPA. Although these revised guidelines 
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are less stringent than those previously developed by the National 
Institutes of Health, we tend to feel that they may be sufficient to 
safeguard human health from effects arising directly from the use 
of recombinant DNA. 
However, we maintain that the original and revised guidelines 
are deficient with respect to protection of the environment. 
Information is not available on the possible extent to which our 
natural environment is in danger from inadvertant exposure to 
different and more complex forms of genetic material. We must take 
all necessary steps to prevent events which could allow release of 
recombinant DNA into the soils, air, waters, of natural environmental 
systems with consequent unknown impact on the biota of those natural 
systems. In fact, our Science Advisory Board, in a statement 
previously circulated within National Institutes of Health, noted 
the need to perform studies on the survival of host organisms, 
both prior and subsequent to insertion of novel genetic materials, 
in various soil, air, and water samples, and model ecosystems. 
[A-153] 
