EPA Plans to Address Confidentiality Claims in Health and Safety Studies under the Toxic Substances Control Act


Source: SOCMA
Related Topics: Toxic Substances Control Act (TSCA)

EPA will begin a general practice of reviewing confidentiality claims for chemical identities in health and safety studies, and in data from health and safety studies, submitted under the Toxic Substances Control Act (TSCA) in accordance with Agency regulations at 40 CFR part 2, subpart B. Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture. Where a chemical identity does not explicitly
contain process information or reveal portions of a mixture, EPA expects to find that the information would clearly not be entitled to confidential treatment. This builds on similar efforts regarding confidentiality of chemical identities listed on the public version of the TSCA Chemical Substances Inventory (TSCA Inventory) and submitted in notifications pursuant to TSCA section 8(e), discussed in the Federal Register of January 21, 2010.

DATES: EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — in accordance with this guidance on August 25, 2010. Though EPA is not required to solicit comment for this action, comments received before this date will inform these reviews.

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