Year End Nanotechnology Developments

Year End Nanotechnology Developments

By William J. Walsh, Of Counsel, Pepper Hamilton LLP

The Environmental Protection Agency's Inspector General (IG) issued a report, EPA Needs to Manage Nanomaterial Risks More Effectively, December 29, 2011 critiquing EPA's regulation of nanomaterials (i.e., particles or fibers with a diameter of 0.1 millionths of a meter), including its lack of required upfront testing and  the operation of statutory protections for confidential  business information, which the IG views as inhibiting peer reviews and oversight by external parties.  The IG urges more coordination internally within EPA, more communication to the public, and that EPA address the limits on its ability to detect, assess, and regulate the risks from nanomaterials.

On December 28th (the day before the Inspector General's report was issued), EPA proposed a significant new use rule (SNUR) for, among other substances, multi-walled carbon nanotubes (generic) (P-10-246) and [5,6] fullerene-C84-D2d (PMN P-09-57).

EPA is using these SNURs to ensure that all manufacturers, importers, and processors of the same chemical substances are subject to similar requirements (e.g., those subject to a consent order and others not working under such an order) EPA's decision to issue SNURs was based primarily on existing data on potential inhalation risks from nanosized particles and nanotubes and potential impacts on aquatic life.

In response to the IG Report's criticisms, EPA pointed out that since 2005 it has reviewed more than 120 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes, and taken a number of actions to control and limit exposures to nanoscale materials.  Similarly, EPA is also proposing a policy classifying any application for registration of a pesticide product containing nanoscale material as an application for a "new" active or inert ingredient.

In summary, while EPA continues to regulate nanomaterials and stakeholders, the Inspector General and GAO, among others, urge even more aggressive action.

Nanotechnology

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