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EPA Reworks Strategy For Regulation of Nanomaterials Under Toxic Substances Control Act (TSCA); Proposed Rule Sent to Office of Management and Budget (OMB)

The Environmental Protection Agency (EPA) has withdrawn its long-delayed proposal to regulate nanotechnology under the Toxic Substances Control Act (TSCA) and submitted a new alternative proposed rule for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. 


[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)).

© 2021 Beveridge & Diamond PC National Law Review, Volume IV, Number 296
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About this Author

Mark N. Duvall Chemicals Regulation Attorney Beveridge & Diamond Washington, DC
Principal

Mark has over two decades of experience working in-house at large chemical companies. 

His focus is product regulation at the federal, state, and international levels across a wide range of programs, and occupational safety and health.

He leads the firm’s Chemicals group. His experience under the Toxic Substances Control Act (TSCA) includes enforcement actions, counseling, rulemaking, advocacy, and legislative actions. Since the enactment of TSCA amendments in 2016, he has been heavily involved in advocacy, compliance activity, and litigation arising from EPA's implementation...

202-789-6090
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