An article published this month in Nanotechnology Law & Business provides a summary of the U.S. Environmental Protection Agency’s (EPA's) recent regulatory efforts under the Toxic Substances Control Act concerning nanomaterials.

In the article, authors Monica and Monica Jr. examine in detail the regulatory actions made by the EPA during the period of 2008-2009, namely the:

• carbon nanotube federal register notice, in which EPA clarified its treatment of nanomaterials under the TSCA;
• two consent orders with a manufacturer of carbon nanotubes;
• two significant new use rules (SNURs) for siloxane-based nanoparticles: siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles;
• two SNURs for single walled- and multi walled carbon nanotubes, which were then withdrawn;
• impending new testing and data collection rules for certain nanomaterials; and
• the proposed acute toxicity rat inhalation testing regimes.

In each case, the authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging area of regulation.

Following analysis of the regulatory actions the authors conclude that, rather than implementing a generalised approach, the EPA is currently demonstrating a case-by-case approach to the regulation of nanomaterials. Monica and Monica Jr. also highlight the limitations of the proposed animal inhalation testing regime, saying:

'While EPA has taken its job seriously and is requiring (or at least suggesting) that animal inhalation studies be undertaken to get at the science of whether or not these materials present human health concerns, the tests themselves are limited and are not designed for use with nanoscale materials.  Additionally, the tests mandated by EPA will be insufficient to establish either scientific or legal causation'.

The authors close by advocating that, 'EPA should work closely with OECD to promulgate nano-specific animal inhalation tests, as well as long term testing techniques, to accompany any future consent orders or SNURs it may issue'

Click here to read the article in full.