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EPA/OCSPP RIN: 2070-AJ87 Publication ID: Spring 2011 
Title: ●CBI: PMN Amendments Claiming Chemical and Microorganism Identity as Confidential in Data From Health and Safety Studies Submitted Under TSCA Prior to the Commencement of Manufacture 
Abstract: EPA is developing proposed amendments to its new chemical and microorganism premanufacture regulations with respect to the information submitted to the EPA under the Toxic Substances Control Act (TSCA). The EPA is developing regulations so that the procedures for claiming chemical or microorganism identity as confidential business information (CBI) in data from health and safety studies are consistent with the language of section 14(b) of TSCA. As a general rule, TSCA section 14(b)(1) provides that health and safety studies and data from health and safety studies are not entitled to confidential treatment, with an exception for information that "discloses processes used in the manufacturing or processing of a chemical substance or mixture," or, in the case of a mixture, where release of the data discloses the portion of a mixture comprised by a particular substance. Chemical identity is part of a health and safety study. As such, chemical identity associated with a health and safety study is not entitled to confidential treatment unless it falls into the exemption under TSCA section 14(b)(1). This action will increase transparency related to chemicals and microorganisms undergoing review prior to the commencement of manufacture, and is also likely to increase the availability to the general public of health and safety data on chemicals in commerce. 
Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
CFR Citation: 40 CFR 720.90(c)    40 CFR 725.92(c)    40 CFR 72   
Legal Authority: 15 USC 2613   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL:  
Sectors Affected: 325 Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Ryan Wallace
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Washington, DC 20460
Phone:202 564-8824

Scott Sherlock
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7408M,
Washington, DC 20460
Phone:202 564-8257
Fax:202 564-8251