Attachment III - Page 2 
DRAFT 
V. RISK ANALYSIS 
Small-scale field testing is a necessary part of risk analysis 
since artificial environments are not adequate simulations of 
natural environments. However, field testing must not be 
undertaken until results of testing in artificial contained 
environments, together with careful consideration of the genetics, 
biology, and ecology of the non-modified and the modified 
organisms, enable a reasonable prediction that no environmental 
risk will result from the release of the modified organism in the 
small-scale test. In this section, the information presented in 
Sections II, III and IV should be summarized to present an 
analysis of risk to the environment in the test as it is proposed. 
The issues addressed might include, but not be limited to, the 
following lines of argument. 
A. The nature of the organism 
1. The role of the non-modified organism in the environment of the 
test site is essentially understood, including any adverse effects 
on other organisms. 
2. Analysis of the genetic modification (eg. deletion, insertion, 
modification of specific DNA sequences) would predict that the 
probability of adverse effects on the environment is low. 
3. Analysis of the tests conducted under contained environments 
would predict that the modified organism would behave no 
differently, except for the known genetic modification, from the 
non-modified organism in the environment of the test site. 
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