12 
Dr. Pirone said the working group did not appear able to resolve differences 
of opinion on the concepts to be include in the preamble. He suggested the 
working group address the data requirements of the body of the document; 
the working group may be able to construct the preamble from the body of the 
document. Dr. Hirano questioned how the working group would be able to write 
a document if they could not agree on the objective of the document. 
Dr. Clowes said the working group should resolve the issue of whether a geneti- 
cally modified organism biochemically identical to an organism found in nature 
would have to be tested to the same extent as a novel organism. 
Dr. Clcwes felt the body of the document should list all of the information 
requirements the working group felt would be pertinent in evaluating field 
testing of modified microorganisms with the understanding that all testing 
requirements might not be required for all submissions. The RAC would deter- 
mine whether adequate information had been submitted by the investigator. 
Dr. Clcwes said an investigator should not be required to perform all of the 
tests listed in the points to consider document if a genetically modified 
organism is identical to an organism already existing in nature. He thought 
the preamble should state this point; if this concept is not stated in the 
preamble of the document, the investigator might feel obliged to apply every 
test to the modified organism. Dr. Gottesman suggested the third paragraph 
of the preamble to the working group document might include the concept that 
"if an organism is identical to an organism existing in nature, it may then be 
treated as a natural analogue." 
Dr. Pimentel said the investigator should supply information on the organism, 
on its behavior in contained systems such as greenhouses, and on the procedures 
to be used in evaluating the effects of the intended field test. RAC would 
have the cption of requiring submission of additional information if it thought 
the proposal did not address important issues. 
Dr. Lacy feared including the sentence preposed by Dr. Gottesmn in the preamble 
would imply recombinant DNA technology merits special concern. 
Dr. Gottesman said she agreed with Dr. Lacy's intent; she did not feel an 
organism should receive special attention simply because it is constructed 
using recombinant DNA techniques. She was concerned, however, that if the 
working group did not address this issue in the preamble individuals reading 
the document would assume that simply because a points to consider document 
exists special concerns must exist. 
Dr. Pirone felt it was politically unwise to include Dr. Gottesman' s preposed 
statement in the document's preamble. Dr. Miller felt the working group 
document should not state dubious concepts in the preamble. 
Dr. Dan Liberman of the Massachusetts Institute of Technology asked whether the 
working group was attempting to provide instruction to investigators or to 
devise environmental assessments before any data or protocols are available. 
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