Attachment V - page 1 
RECOMBINANT DMA ADVISORY COMMITTEE 
NATIONAL INSTITUTES OF HEALTH 
APPLICATION PROCEDURES EOK LARGE-SCALE 
RECOMBINANT DMA EXPEkIMENTS 
Tr.e current Guidelines for Research Involving Recombinant DMA Molecules 
( Federal Register / December 22, 1S78) contain two statements concerning 
large-scale experiments. In the section on prohibitions the following 
provision appears: 
The following experiments are not to be initiated at the present 
time 
I-D-6. Large-scale experiments (e.g., more than 10 liters of 
culture) with organisms containing recombinant DNAs, unless the 
recombinant DNAs are rigorously characterized and the absence of 
harmful sequences established [3J . (See Section IV-E-l-b-(3)-(d) . ) 
The second statement is included in the section of the Guidelines on 
roles and responsibilities: 
The [NIH] Director is responsible for the following actions:... 
IV-E-l-b-(3)-(d) . Authorizing, under procedures specified by the 
RAC (Recombinant DMA Advisory Committee] , large-scale experiments 
(i.e., involving more than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized and free of harmful sequences 
(see Footnote 3 and Section I-D-6);... 
This memorandum specifies the procedures to be followed by applicants 
for exceptions to the 10-liter limit. 
1. For each research project proposing to exceed the 10-liter limit, 
the applicant shall file a request with the NIH Office of Recombinant 
DMA Activities (ORDA) . The request should include the following 
information: 
a. The Memorandum of Understanding and Agreement (MUA) submitted 
to the local Institutional Biosafety Committee. The MUA should 
include, or have appended to it, a summary paragraph which 
describes the proposed project in language that is comprehensible 
to non-specialists. 
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