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.