New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Posted on October 16, 2009 by John C. Monica, Jr.

Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

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EPA Issues Significant New Use Rules for Multi-Walled and Single-Walled Carbon Nanotubes

Posted on June 26, 2009 by John C. Monica, Jr.

In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.



 

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Lab Experiments Suggest "Buckyballs" Not Toxic

Posted on August 29, 2007 by Michael E. Heintz
Recent experiments involving "in vivo" testing of C-60 fullerenes, or "buckyballs" appears to conflicts with prior, "in vitro" tests and shows that the nanomaterials may not be toxic when inhaled.  Scientists at DuPont conducted experiments on lab rats by implanting the C-60 compound into the rats' tracheas and then looked for signs of damage.

Upon review, the scientists determined that while the rats experienced  inflammation and cell damage one day after exposure, but that there appeared to be no long-term damage.  The long term exposure did not differ significantly than the responses noted in the control group.  These results seem to run counter to prior, in vitro tests performed on human cells, that showed some amount of damage. 

These results indicate a couple of points.  First, it is clearly too early in the testing of nanomaterials to declare them, carte blanche, safe or harmful.  Much more study is needed to resolve the apparent conflicts in data results.  Second, testing using in vitro methods alone may not be sufficient to gain a clear understanding of the health impacts on nanomaterials.  Third, using in vitro experiments to predict in vivo responses may be inappropriate. 

These latest results underscore the need for more, and more thorough, research involving nanomaterials and the potential health impacts.  Any stated conclusion concerning the safety of nanomaterials, either that they are safe or toxic, is premature at this stage, and such statements should be viewed with an air of skepticism.
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