5 
Dr. Tolin said Section V, Risk Analysis , attempts to offer guidance on synthe- 
sizing ard analyzing the information requested in Sections II, III, and IV of 
the document. The nature of the modified organism and the nature of the pro- 
posed tests are emphasized as major considerations. Part A, The Nature of the 
Organism, of Section V poses a question for each of the major sections of the 
working group document. Part B, The Nature of the Test , of Section V requests 
a surrmary of testing protocol information. Section V does not indicate hew 
the proposal will be reviewed. 
Dr. Robert Colwell of the University of California, Berkeley, felt proposed 
Section V was a good primer. He was troubled, however, by the section's 
declarative format. He suggested the language of proposed Section V be softened 
by adding the phrases "proper and appropriate" and "if necessary." 
Dr. Pimentel agreed proposed Section V was well thought cut. He suggested the 
committee consider substituting the word "predicted" for the word "probability" 
in Section V. 
Dr. McGarrity suggested the working group begin by considering the first two 
sentences of Section V. These sentences read as follows: 
"Small-scale field testing is a necessary part of risk analysis since 
artificial environments are not adequate simulations of natural environ- 
ments. However, field testing must not be undertaken until results of 
field testing in artificial contained environments, together with careful 
consideration of the genetics, biology, and ecology of the nonmodi fied 
and the modified organisms, enable a reasonable prediction that no environ- 
mental risk will result from the release of the modified organism in the 
small-scale test." 
Dr. Gottesrran said the language in the second sentence suggesting test results 
should permit a reasonable prediction of "no environmental risk" is too absolute. 
She pointed out that some risk of adverse environmental effects might be accept- 
able in certain cases in view of potential benefits. In addition, RAC might 
recognize some cases as "trivial" and require less stringent review. 
Dr. Pimentel said the document should not allude to "trivial cases, " as it is 
currently impossible to determine which proposals would require less stringent 
review. Dr. Sharpies agreed; she said even if the organism is familiar, it 
should be evaluated in the context of the proposed field test. 
Dr. Pimentel suggested the first sentence should indicate artificial environ- 
ments are "not fully" adequate simulations. Dr. Vidaver suggested the sentence 
should state artificial environments are "not necessarily" adequate simulations. 
Dr. Colwell suggested artificial environments are "not always" adequate simulations. 
Dr. Carl Mazza of the EPA suggested the first two sentences in Section V be 
deleted. He felt these sentences did not discuss any new concepts; the 
document's preamble states the reasons field testing is necessary. The second 
sentence could be interpreted as categorically stating that field testing must 
not be undertaken until closed system testing indicates no environmental risk 
will occur. 
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