7 
a product unquestionably beyond its jurisdiction. For example, 
although drugs and pesticides are absolutely and specifically 
excluded from TSCA's definition of "chemical substances," 4/ 
EPA nonetheless has asserted that "a microbe that is genetically 
engineered to produce a drug or pesticide may be subject to 
regulation under TSCA." 5/ 
C. Why EPA Should Not Exercise the Scope of 
Authority It Seeks 
1 . The Scope Is Beyond That Granted by TSCA 
A significant flaw in EPA's analysis of the scope of its 
authority is its claim of authority over the closed fermentation 
process. Testing authority and restrictive authority clearly 
apply to the product being manufactured and not to substances 
that are part of the process. The Administrator is empowered to 
require testing only for products that, once manufactured, may 
present an unreasonable risk, 67 not for components of the 
process itself. 
The legislative history of TSCA, moreover, specifically 
precludes EPA jurisdiction over the process components of 
4/ 15 U.S.C. §§ 2602 (B ) (vi ) and (ii), respectively. 
5/ EPA Position Paper at 23. In the context of^the paper, it 
is clear that "may be subject" means "can be" and not 
"might be." 
6/ 15 U.S.C. § 2603. 
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