In the context of auto- immune disease, however, the gene speci- 
fying any foreign protein must be considered potentially harmful. 
7. The expression of even a "normal" metabolic enzyme 
in human, animal or plant cells which was not under the control 
of the cell's normal complex regulatory mechanism, could lead 
to severe metabolic disruptions and an ensuing disease 
state, similar to existing cases of metabolic disease 
where the defect is in a regulatory gene, rather than 
once coding for a specific enzyme. 
Both the NIH guidelines and the Impact Statement recognize 
that humans harboring or infected by bacteria or viruses con- 
taining recombinant DNA may, under certain conditions, suffer 
a variety of serious adverse health effects. If such modified 
bacterial or viral agents can survive and propagate outside the 
laboratory and thus produce new identical organisms capable of 
producing infection and/or toxic effects on human beings, there 
exists the potential for a "communicable disease" within the 
meaning of Section 361 of the Public Health Service Act (42 
U.S.C. §264) (see Section II above). Because some of the 
organisms created by recombinant DNA research have never existed 
before, the health and environmental effects of such novel 
microorganisms are inherently unpredictable. Nevertheless, the 
danger of the creation of a potentially serious communicable 
disease organism makes it incumbent upon the Department of 
Health, Education and Welfare to exercise its statutory authority 
and take whatever regulatory measures are necessary to protect 
the public health. 
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