9 
"The oxphasis of the investigators discussion should be to provide adequate 
information with which to make an assessment of whether the modified organism 
is f unctionally unique . " 
Dr. Colwell said the prearible to Section III, Environmental Considerations , 
states this concept. Dr. McGarrity suggested this concept might also be stated 
in the preamble to the document. 
Dr. McGarrity suggested the preamble to the document should have three objectives. 
( 1 ) the first paragraph should request that the investigator define the proposed 
experiment; (2) the second paragraph should request an explanation of the 
purpose and objective of the experiment; and (3) the third paragraph should 
explain the rationale behind case-by-case review. Dr. Hirano said the preamble 
should also clearly state that the primary focus of review is to evaluate 
potential ecological effects. 
Dr. Lacy suggested the second and third paragraphs of the current preamble 
(Attachment II) should be fused into one paragraph; the sentence suggested by 
Dr. Sharpies would serve as cement. 
Dr. Pirone reiterated that the preamble should not mention the concept of 
"uniqueness;" the working group and RAC would determine "uniqueness" frcm the 
information provided in the proposal. If the preamble of the draft document 
refers to uniqueness in a very general way, the investigator might draw his 
own conclusion on whether the modified organism is unique. Dr. Lacy strongly 
supported this argument; he thought at most the preamble should only indicate 
that the working group wishes to evaluate risk. 
Dr. Clcwes disagreed. He thought the investigator would be penalized for 
utilizing recombinant DNA techniques in developing the organism if all 
organisms constructed using recombinant DNA techniques are subject to the 
ccnplete testing list devised by the working group. 
Dr. Arntzen agreed the concept of uniqueness should not be mentioned in the pre- 
amble of the working group document. He said the working group must address 
data generated from model systems such as microcosms and greenhouses, evaluate 
the desired effect in the model system, and extrapolate to expected results in 
the field test. The questions to be asked are: (1) why is the experiment being 
performed; (2) what criteria would be used in evaluating the preposed field 
testing; and (3) what was the expression of the desired effect in the greenhouse. 
The purpose of addressing these questions is to £:>redict the effects of field 
testing. An extrapolation from responses to these questions will indicate 
anticipated data and potential risk to the environment. 
Dr. Arntzen said specifically discussing the concept of uniqueness in the 
preamble of the document imparts a philosophical bias which the working 
group should avoid. He said the working group should recognize that a field 
test is not an end in itself. Rather, it is part of a research continuum which 
includes testing in the laboratory; testing in the microcosm, growth chamber 
or greenhouse; limited field testing; and large-scale field testing. 
Dr. Arntzen thought the preamble should: (1) indicate that data developed in 
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