Attachment IV - Page 1 
POINTS to CONSIDER FDR SUBMISSIONS INVOLVING TESTING IN THE ENVIRONMENT 
OF MICROORGANISMS DERIVED BY RECOMBINANT DNA TECHNIQUES 
Experiments in this category require specific review by the Reccnbinant ENA 
Advisory Camittee (RAC) and approvals by the National Institutes of Health 
(WIH) and 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 
DNA 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 DNA techniques. 
These following 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 DNA 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, some 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 depend on the properties of the parental 
organism and the effect of the modification on these properties. 
RELEASE INTO THE ENVIRONMENT 
WORKING GROUP DRAFT 10/30/84 
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