22 
the process for manufacturing a product excluded from TSCA, as 
well as the products themselves, are beyond the purview of the 
statute. If the government decides to seek a more felicitous 
regulatory tool, it should work with industry, public interest 
groups, and the scientific community towards the development of 
a rationale scheme to promote its regulatory goals while pre- 
serving the United States' international competitive position 
and the viability of the smaller genetic engineering firms. 
III. COMMENTS ON RECOMMENDATIONS (2) - (6) 
Genentech also disagrees with recommendations (2)- (6). 
The purpose of Genentech's comments are not to question the 
wisdom of additional regulation of deliberate release. It would 
note, however, that it is unclear how further regulation of "low 
probability of high consequence risks" will produce benefit, 
given that "predicting the specific type, magnitude, or proba- 
bility of environmental effects associated with a deliberate 
release will be extremely difficult at the present time." 42 / 
, Since "there are almost no accepted methodologies for 
evaluating the safety of genetically engineered products," 43/ 
42/ See conclusions of the Gore Report, 49 Fed. Reg. 17683. 
43 / See Clay Statement at 11. 
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