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EPA/OCSPP RIN: 2070-AJ87 Publication ID: Spring 2013 
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 considering a proposal to amend the procedures under 40 CFR 720 and 725 for submitting information for new chemicals and microorganisms under the Toxic Substances Control Act (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 proposal would amend the procedures for claiming chemical or microorganism identity as confidential business information (CBI) in data from health and safety studies to be consistent with the language of section 14(b) of the Toxic Substances Control Act (TSCA). This action would also increase transparency related to chemicals and microorganisms undergoing review prior to the commencement of manufacture, and would also increase the availability to the general public of health and safety data on chemicals in commerce. 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 720.90    40 CFR 725.92    40 CFR 725.94   
Legal Authority: 15 USC 2613   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2013 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html  
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
7408M,
Washington, DC 20460
Phone:202 564-8824
Email: Wallace.Ryan@epa.gov

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
Email: sherlock.scott@epa.gov