2 
little chance of a vixus or organism being created which is 
rendered potentially harmful by the addition of recomljinan t DNA 
to its genome, and that if such a harmful agent should arise, the 
probability of the escape of such an organism or virus into the 
environment, either directly or by the infection of laboratory 
personnel, is extremely low. The statement on p. 64, "Any 
potential release of high-risk materials to the environment 
should be prevented by adherence to the NIH Guidelines," indeed 
suggests that the Guidelines have adequately taken into account 
all possible ways in which any potential biological hazard arising 
from reconibinant DNA research could enter the environment, and 
that there is no further need to improve them. This conclusion 
would, thus, appear to be at odds with the statement in the 
introduction quoted above. It is possible that this apparent 
inconsistency reflects a measure of uncertainty on the part of 
the authors of the impact statement. Nevertheless, most of the 
impact statement expresses a great deal of confidence in the 
Guidelines and it is the presumed basis for this confidence that 
will be the subject of much of this discussion. 
The conclusion of the impact statement, that the Guidelines, 
if observed, do indeed afford sufficient safety to the environ- 
ment, is necessarily based upon three implicit assumptions. If 
any of these assumptions is not justified, then it follows that 
neither is the belief that the Guidelines \\?ill provide the measure 
of safety attributed to them in the impact statement. These 
assumptions are: 
Appendix K — 56 
