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EPA Reworks Strategy For Regulation of Nanomaterials Under TSCA; Proposed Rule Sent to OMB

By: Mark Duvall and Andie Wyatt
October 13, 2014

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The Environmental Protection Agency (EPA) has withdrawn its long-delayed proposal to regulate nanotechnology under the Toxic Substances Control Act (TSCA) and submitted a new alternative proposed rule for consideration and regulatory review by the Office of Management and Budget (OMB). The new proposed reporting rule, submitted by EPA on October 6, 2014, replaces plans that had been under review by OMB since 2010.[1] 

According to the OMB Regulatory Agenda item abstract,[2] the new proposal drops prior plans to propose a significant new use rule (SNUR) under TSCA Section 5(a)(2), which would have required persons intending to manufacture, import, or process designated nanomaterials for new uses to notify EPA at least 90 days in advance.  EPA’s current proposal retains the prior plan “to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.”  The information gathered is intended to enable EPA to evaluate the need for additional regulations under TSCA. The proposed rule is not yet public. 

EPA’s regulatory tracker[3] projects that the proposed rule will be published in the Federal Register around March, 2015.  A period of public comment, EPA response and possible revisions, and further OMB review will follow before the rule can be finalized.  Despite this long timeframe, the proposed reporting rule could be the first major U.S. federal rule to specifically regulate nanomaterials as a category. 

Beveridge & Diamond assists clients with the shifting regulatory landscape affecting nanomaterials. Working alongside our clients’ legal, EHS and technical teams, we help resolve critical environmental and sustainability issues relating to their facilities, products, and operations. For more information, please contact Mark Duvall at mduvall@bdlaw.com or Alexandra Wyatt at awyatt@bdlaw.com, or any member of our Nanotechnology Practice.


[1] See Beveridge & Diamond, P.C., “Update on Developments in EPA Regulation of Nanotechnology,” April 5, 2010.

[2] OMB, Office of Information and Regulatory Affairs (OIRA), Executive Order Submissions Under Review, RIN: 2070-AJ54: EPA/OCSPP Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.

[3] EPA Regulatory Development and Retrospective Review Tracker, Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; a.k.a. Nanoscale - Reporting Rule (TSCA Section 8(a)).

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