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EPA’s Proposed Nano Rule: What Should You Be Doing Now?

This article was co-authored by Jo Anne Shatkin, Founder at Vireo Advisors.

In its first step towards regulating nanoscale materials, EPA plans to impose a one-time electronic reporting and recordkeeping requirement under TSCA on manufacturer (“manufacturer” is defined to include importers) and processors of particles ranging from 1-100 nanometers and exhibiting unique characteristics due to their size.

Suggested actions if you are subject to the Proposed Rule:

  • Assess whether you are manufacturing or processing multiple forms of nanoscale material—if so, each form must be reported.
  • Assess whether you have the required information, which includes: production volume, methods of manufacturing and processing, use, exposure and release information, and available health and safety data.
  • Assess whether proprietary information is included in the information you must submit--if so, certain steps must be taken.

Exemptions from the Proposed Rule exist if:

  • The manufacturer or processor’s yearly sales are less than $4M;
  • Certain other reporting under TSCA and the Nanoscale Materials Stewardship Program has already occurred;
  • The substance is contained in an article;
  • The substance is used in small quantities only for R&D;
  • Substances identified solely as an impurity or byproduct;
  • Substances manufactured or processed in small quantities solely for R&D;
  • Any food, food additive, drug, cosmetic, medical device or pesticide;
  • DNA, RNA, proteins; zinc oxide, nanoclays, and chemical substances manufactured at the nanoscale as part of a film on a surface; and
  • Chemical substances that dissociate completely in water to form ions of less than 1 nanometer.

Under the Proposed Rule, reporting must begin for existing substances within six months of the rule’s effective date or at least 135 days before a substance is first manufactured or processed. The public comment period ends on July 6 and more information on how to comment can be found here on EPA’s website.

To view the full Mintz Levin Environmental Law Alert on this topic, click here.

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Katy E. Ward

Contract Attorney

Katy E. Ward practices environmental law and corporate and securities law at Mintz. Katy's environmental law practice includes litigating in state and federal court. Her corporate practice focuses on the venture capital space, representing venture capital firms and emerging companies.