applies to all five regulatory regions noted in the Framework. 
As regards the predictability of the behavior of these regions, 
it must be remembered that precision in molecular biological 
experiments must not be confused with the precision in the 
predicting of their ecological consequences. 
The regulatory elements in question are placed in the 
organism in order to manipulate, through increasing or decreasing 
the production of a gene product. The effect of this alteration 
of the organism as a whole, or on its relationship to other 
organisms in the environment, would be unknown. 
Some of the possible results would be: a) to make a better 
competitor, thereby changing the biological niche by eliminating 
or decreasing the numbers of other organisms; b) to alter the 
abiotic (e.g., mineral) environment by the altered organism using 
abiotic substances not ordinarily needed; or c) the altered 
organism altering its environment by excreting different amounts 
of substances. 
The operator itself, which is subject to external stimuli by 
small molecules, could be altered in an unpredictable fashion. 
For example, the generation time of the bacteria could be slowed 
or sped up with resulting effects on the altered organism's 
biological niche. 
Thus, the implicit assumption in the BSCC definitions, 
namely, that an organism could be made "novel" (thereby causing 
potential risks to the environment) only by the introduction of a 
new nucleotide base sequence, is clearly false. Changing the 
ratio of gene products by altering any or all of the regulatory 
elements could readily result in "novel," potentially hazardous 
organisms . 
It is equally clear from the cited language in the 
definitions that the BSCC has paid no attention to the possible 
ecological consequences of altering the regulatory elements 
(regions), for, as stated, such regulatory changes can create 
"novel* organisms which are eminently suited to disrupt 
ecological niches. 
Additionally, to the extent that the definitions do not 
include intrageneric, genetically engineered products, such as 
gene deletions or other rearrangements of genetic material, the 
definitions are incomplete and deficient. Gene deletions and 
other intrageneric genetic rearrangements should without question 
be included in the Framework as biotechnology products requiring 
full regulatory review. 
Recombinant DNA Research, Volume 1 1 
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