Attachment XIV - Page 1 
POINTS TO CONSIDER FOR SUBMISSIONS INVOLVING RELEASE OF MICROORGANISMS 
CONTAINING RECOMBINANT DNA MOLECULES INTO THE ENVIRONMENT 
Experiments in this category require specific review by the Recombinant CNA 
Advisory Ccrrmittee (RAC) and approval by the National Institutes of Health 
(NIH) and the Institutional Biosafety Committee (IBC) before initiation. 
Relevant information on the proposed experiments should be submitted to the 
Office of Reccmbinant CNA Activities (ORDA) . 
The following outline has been developed by the Working Group on Release into 
the Environment as a suggested list of "Points to Consider" for scientists 
preparing proposals on release into the environment of microorganisms including 
viruses . 
The review of proposals for environmental release of organisms containing 
recombinant DNA is best done on a case-by-case basis. Given the infinite range 
of possible organisms and possible environments no single set of tests is likely 
to answer all questions. However, seme common considerations allow the con- 
struction of "Points to Consider" such as those belcw. 
For the evaluation of the risk associated with the release of a recombinant CNA 
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. 
If the probability of any one of these factors is zero, the risk should be 
considered zero. 
1) Is the organism unique? The special concern given to recombinant CNA 
containing organisms is based on the assumption that the organism being 
RELEASE INTO THE ENVIRONMENT 
WORKING GROUP DRAFT, 10/5/84 
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