TABLE OF CONTENTS 
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I. Introduction 1 
A. Genentech, Inc 1 
B. Background of Industry 1 
II. Genentech' s Position on the 
First Recommendation 4 
A. Statement of Disagreement 4 
B. EPA Documents Indicate That If the Agency 
Exercises Authority Under TSCA as to 
Deliberate Release of Genetically Engineered 
Organisms, It Will Seek Authority Over The 
Entire Genetic Engineering Industry 6 
C. Why EPA Should Not Exercise 
The Scope of Authority It Seeks 7 
1. The Scope Is Beyond That 
Granted by TSCA 7 
2. The Scope of Authority EPA Desires 
Would Provide Virtually No Benefit ... 9 
a. The Guidelines Are Applicable 
to Industry 10 
b. The Current Regulatory Structure 
Insures Adequate Environmental 
Expertise 13 
c. The Current Regulatory Structure 
Permits Adequate Review of the 
Manufacturing Process 15 
3. The Scope of Authority EPA Desires 
Would Produce Considerable Harm 19 
D. Conclusion 21 
III. Comments on Recommendations (2) - (6) 22 
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