DRAFT 
Attachment V - Pa 
POINTS TO CONSIDER FDR SUBMISSIONS INVOLVING TESTIN3 IN THE ENVIRONMENT f 
OF MICROORGANISMS DERIVED BY RECOMBINANT DNA TECHNIQUES 
Experiments in this category require specific review by the Recombinant ENA 
Advisory Carmittee (RAC) and approvals by the National Institutes of Health 
(NTH) arrl the Institutional Biosafety Committee (IBC) before initiation. The 
IBC is expected to make an independent evaluation although this evaluation need 
not occur before consideration of an experiment by the RAC. Relevant informa- 
tion on the proposed experiments should be submitted to the Office of Recombinant 
ENA Activities (ORDA). The objective of this review procedure is to evaluate 
the potential environmental effects of testing of microorganisms that have 
been modified by recombinant TNA techniques. 
These fbllowinq points to consider have been developed by the RAC Working Group 
on Release into the Environment as a suggested list for scientists preparing 
proposals on environmental testing of microorganisms, including viruses, that 
have been modified using recombinant ENA techniques. The review of proposals 
for environmental testing of modified organisms is being done on a case-by-case 
basis because the range of possible organisms, applications, and environments 
indicate that no standard set of procedures is likely to be appropriate in all 
circumstances. However, seme common considerations allow the construction of 
points to consider such as those below. Information on all these points will 
not be necessary in all cases but will dep>end on the properties of the parental 
organism and the effect of the modification on these properties. 
RELEASE INTO THE ENVIRONMENT 
WORKING GROUP CRAFT 02/11/85 
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