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EPA/OPPTS RIN: 2070-AB61 Publication ID: Fall 1996 
Title: Rulemaking Concerning Certain Microbial Products (Biotechnology) Under the Toxic Substances Control Act (TSCA) 
Abstract: EPA is promulgating a regulation under the Toxic Substances Control Act (TSCA) for the oversight of certain microbial products of biotechnology. The rule would be issued under the authority of Section 5 of TSCA, which generally requires that new chemical substances must be reviewed by EPA before they are introduced into commerce. The rule will contain mechanisms for exemption as well as actual exemptions, guidance on how the TSCA Inventory will be used, and EPA's approach to Research and Development with biotechnology microorganisms. 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 700    40 CFR 720    40 CFR 721   
Legal Authority: 15 USC 2604/TSCA 5   
Timetable:
Action Date FR Cite
NPRM  09/01/1994  59 FR 45526   
Final Action  11/00/1996    
Additional Information: SAN No. 2326. ^PRFA: Y
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations 
Included in the Regulatory Plan: No 
Agency Contact:
Paul Campanella
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M,
Washington, DC 20460
Phone:202 564-8091
Email: Campanella.Paul@epa.gov