EPA’s Proposed Nanomaterial Rule

In its first step towards regulating nanoscale materials, EPA plans to impose a one-time electronic reporting and recordkeeping requirement under TSCA on manufacturers, importers and processors of particles ranging from 1-100 nanometers and exhibiting unique characteristics due to their size.  Until now, nanoscale versions of substances already on the TSCA Inventory have been exempt from reporting requirements.

A manufacturer, importer and processor should first assess whether they are subject to the Proposed Rule.  A company handling a nanoscale material is exempt if that material is contained in an “article.”  An article is something that has a specific shape and an end-use that is dependent on that shape.  Anything that is intended to be removed is not considered part of the article and must be reported (e.g., ink from a pen).

A manufacturer, importer and processor may also be exempt from the Proposed Rule if:

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

If you expect to be subject to the Proposed Rule, for starters, we suggest assessing whether:

• You are manufacturing, importing or processing multiple forms of nanoscale material—if so, each form must be reported.
• 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.
• Proprietary information is included in the information you must submit–if so, certain steps must be taken.

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 EPA will hold a public meeting to receive comments at EPA headquarters on June 11.
The comment period is an important opportunity to provide input, and the entire Proposed Rule is subject to change, so stakeholders should comment both on items they support and those they want changed.