8 
Drs. McGarrity, Gottesman, and Tblin suggested the working group focus on 
developing the body of a working group document; an appropriate title may 
become obvious after the document is written. 
Dr. Arntzen suggested part A, Source organisms , of the TSCA document (Attachment 
VII) should be substituted for sections II and III of the subgroup draft document 
(Attachment IV ) . 
Dr. Lacy suggested the term "nucleic acid" be substituted for the term "DMA" in 
any document developed by the working group. He noted that some research 
efforts might utilize RNA. Dr. McGarrity said the NIH Guidelines define recom- 
binant DtCA molecules as either: (i) molecules vhich are constructed outside 
living cells by joining natural or synthetic DNA segments to DMA molecules 
that can replicate in a living cell, or (ii) DNA molecules that result from 
the replication of those described in (i). 
Dr. Gottesrran suggested the working group develop a structural outline for a 
working group document. She suggested a working group document should focus 
primarily on the unique characteristics of the recombinant organism and should 
ask for information pertinent to determining the degree of modification of the 
organism. A working group document should also require information on modifi- 
cation methods and on testing. 
Dr. Gottesrran said RAC will require monitoring information and data to be gener- 
ated in order to develop a data base pertinent to organisms modified by recom- 
binant DNA technology; therefore, a working group document should clearly state 
that information generated from test cases will form the data base for future 
reviews. Dr. Vidaver suggested such a statement should appear at the end of a 
working group document. 
Dr. Arntzen suggested a working group document should have a preamble, should 
be applicable to all classes of microorganisms, and should ask the investigator 
to explain the purpose of the experiment and to define the scope of the proposal. 
Dr. Pramer said a preamble to a working group document should include a statement 
recognizing the complexity of the subject. Dr. Clowes said the preamble should 
indicate that the document attempts to be pertinent to a wide variety of circum- 
stances, thus, some informational requests will be irrelevant for some proposals. 
Dr. Colwell supported Dr. Clowes' statement. 
Dr. McGarrity suggested a working group document should include the language 
found in the first two paragraphs of the subgroup preliminary draft document 
(Attachment IV). Dr. McKinney suggested the first paragraph of the working 
group document should read: 
"Experiments in this category require specific review by the Recombinant 
DISPA. Advisory Committee (RAC) and approval by the National Institutes of 
Health (NIH) and the Institutional Biosafety Committee (IBC) before initi- 
ation. Relevant information on the proposed experiments should be submitted 
to the Office of Recombinant DMA Activities (ORDA)." 
[ 18 ] 
