Attachment XIV - Page 2 
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considered did not exist before in nature and, therefore, may have same 
unexpected properties. If the organism is essentially identical to one 
found in nature, then it can be treated in the same way as natural analog . 
The Guidelines for Research Involving Recombinant ENA Molecules exempt 
certain organisms from the requirements of the Guidelines because they 
represent variants which may arise by natural means (see Sections III-D-2, 
III-D-3, and III-D-4). Thus, vhile sill experiments involving release of 
recombinant DNA containing organisms must undergo NIH review (under Section 
III-A-2), the probability of a unique organism being formed should be 
relatively lew for those organisms vhich meet the requirements of Sections 
III-D-2, III-D-3, and III-D-4. 
2) What is the probability of the establishment in the environment of the 
recombinant organism or the recombinant DNA it contains. Survival of the 
organism, stability of the inserted ENA, and ability of the organism to 
grow and compete with other organisms will all be relevant in dete mining 
this probability value. In addition, the possible mechanisms for transfer 
of the recombinant DNA to other organisms and the availability of those 
organisms at the release site will be important. Finally, the nurrber of 
organisms to be released will help determine hew stability and transfer 
information should be interpreted . 
3) What is the probability of the organism or a product of the organism causing 
ham? For this consideration, one should assume that establishment in the 
environment has occurred. The probability of ham can be estimated from 
an analysis of the known properties of the parental unmodified organism. 
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