EPA Sends OMB Proposed Rule on Confidentiality in TSCA Chemical & Microorganism Notices
On December 27, 2011, the Environmental Protection Agency sent to the Office of Management and Budget a proposed rule entitled, "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." EPA states it 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).
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CBI for processes, substances in mixtures. 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.
No CBI for chemical identity unless exempt. 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).
Chemical and microorganism transparency. EPA states that this rulemaking would 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.