Attachment IV - Page 7 
7 
US REMOVED FROM BOTTOM ON PAGE 1, PAGE 2, AND TOP OF PAGE 3 OF 10/5/84 DRAFT: 
For the evaluation of the risk associated with the release of a recombinant ENA 
containing organism into the environment, the probability of an adverse effect 
will be the product of the probabilities of each of the following three factors. 
The special attention given to recombinant DNA containing organisms is based on 
the assumption that the organism being considered did not exist before in nature 
and, therefore, may have some unexpected properties. If the organism is 
essentially identical to one found in nature, then it can be treated in the 
same way as the natural analog. The Guidelines for Research Involving Recombi- 
nant DNA Molecules exempt certain organisms from the requirements of the Guide- 
lines because they represent variants which may arise by natural means (see 
Sections III-D-2, III-D-3, and III-D-4). Thus, vhile all experiments involving 
release of recombinant DtSA containing organisms must undergo NIH review (under 
Section III-A-2), the probability of a unique organism being formed should be 
relatively low for those organisms vhich meet the requirements of Sections 
III-D-2, III-D-3, and III-D-4. 
What is the probability of the establishment in the environment of the recombi- 
nant organism or the recombinant DNA it contains. Survival of the organism, 
stability of the inserted DNA, and ability of the organism to grow and compete 
with other organisms will all be relevant in determining this probability 
value. In addition, the possible mechanisms for transfer of the recombinant 
DNA to other organisms and the availabiltiy of those organisms at the release 
site will be important . Finally, the number of organisms to be released will 
help determine how stability and transfer information should be interpreted. 
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