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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))


RIN: 2070-AJ54 (What's this?)

Docket No.: EPA-HQ-OPPT-2010-0572 (What's this?)

Current Phase: Proposal (What's this?)

Abstract:
In April 2015, EPA proposed reporting and recordkeeping requirements under section 8(a) of the Toxic Substances Control Act for certain chemical substances when they are manufactured or processed at the nanoscale.

Specifically, EPA proposed to require persons that manufacture (defined by statute to include import) or process, or intend to manufacture or process these chemical substances to electronically report to EPA certain information, which includes the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. This proposal involves one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. This information would facilitate EPA's evaluation of the materials and a determination of whether further action, including additional information collection, is needed. Consistent with the President's memorandum for Executive Agencies regarding Principles for Regulation and Oversight of Emerging Technologies, this proposed rule would facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.
Timeline

MilestoneDate
Initiated06/11/2009
NPRM: Sent to OMB for Regulatory Review11/18/2010
NPRM: Received by OMB11/22/2010
NPRM: Sent to OMB for Regulatory Review10/06/2014
NPRM: EPA Withdrew Rule from Review10/06/2014
NPRM: Received by OMB10/06/2014
NPRM: Regulatory Review Concluded03/19/2015
NPRM: Published in FR04/06/2015
NPRM: Comment Period Open04/06/2015
NPRM: Comment Period Extension Published in FR07/02/2015
NPRM: Comment Period Closed07/06/2015
NPRM: Comment Period Closed with Extension08/05/2015
Final Rule: Published in FR06/2016 (projected)

Potential Effects

International Effects
This rulemaking is expected to have international trade and investment effects, or otherwise may be of interest to our international trading partners.

Small Entities
EPA notifies the public when a rulemaking is likely to 1) have any adverse economic impact on small entities even though a Regulatory Flexibility Analysis may not be required and/or 2) have significant adverse economic impacts on a substantial number of small entities. The term "small entities" includes small businesses, small governments, and small not-for-profits. (Read a longer explanation on our Small Entities web page.) This rulemaking is likely to impact small entities in the following way(s):
  • Likely to have any adverse economic impact on:
    • small businesses

Participate / Learn More

Comment Period Open (04/06/2015 until 07/06/2015) - Click to access the document on Regulations.gov and comment by clicking "Submit Comment" near the top of the Regulations.gov page.

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Regulatory Review

Some of EPA's rulemakings undergo regulatory review (What's this?), as prescribed by Executive Order 12866 and coordinated by the Office of Management and Budget (OMB). The following list describes which of this rulemaking's stages have completed review and published in the Federal Register, if any, and provides links to the review documents where available. Consult the "Timeline" section of this Web page for the dates of each review.

  • NPRM - This stage of the rulemaking underwent review.
Citations & Authorities

Federal Register Citations

Code of Federal Regulations (CFR) Citation
40 CFR 704

Legal Authority
15 U.S.C. 2604(a);15 U.S.C. 2607(a) Toxic Substances Control Act

Disclaimer

This site provides summaries of priority rulemakings and priority retrospective reviews of existing regulations. We update most of the site at the beginning of each month, though some data is updated more frequently if it is time sensitive. The information on this site is not intended to and does not commit EPA to specific conclusions or actions. For example, after further analysis, EPA may decide the effects of a rule would be different or it may decide to terminate a rulemaking.


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