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EPA Defining Regulatory Intentions Towards Nanotechnology (Updated 4/19/2010)

Within the last two weeks, EPA has more clearly defined its regulatory intentions regarding nanotechnology and will be enacting a number of regulatory measures under TSCA and FIFRA in 2010 as well as strengthening its enforcement efforts.

EPA will issue a TSCA section 8(a) reporting rule this summer, possibly June, for all nanomaterials currently on the market. This rule will require companies to report on data for existing uses, production volumes, methods of manufacture and processing, exposure and release information, available health and safety data, and specific physical properties, along with chemical and structural characteristics.

Additionally, EPA will issue by November 2010 a Section 4 test rule for single and multi-walled carbon nanotubes with relatively high production and exposure scenarios, nanoclays and alumina.

By the end of 2010, EPA plans to issue a categorical significant new use rule (SNUR) under TSCA section 5(a)(2) in order to regulate the nanoparticle versions of chemicals currently on the TSCA inventory list.  According to the EPA website, a Significant New Use Notice (SNUN) must be submitted at least 90 days prior to the manufacture, import or process of a nanomaterial. According to an April 5th briefing from Beveridge and Diamond, PC, this “SNUR would apply to any chemical for which more than 10% of its particle range is 1-100 nanometers, unless already reported as a new use.”

According to Michael Bellot, Chief of the Chemical Risk and Reporting Enforcement Branch in the Office of Enforcement and Compliance Assistance (OECA), approximately two-thirds of EPA’s enforcement actions in 2009 were taken against nanomaterial producers.  EPA inspectors are focusing on ensuring that companies file premanufacture notices (PMNs) appropriately and comply with any SNURs.  They will also review low volume exemptions (LVEs) in order to make certain exemption requests are actually filed.  However, according to the April 5th Beveridge and Diamond brief, the only exemption EPA has been granting for any nanomaterials is for low-exposure, low-release chemicals and not the low volume exemption.

Finally, EPA will issue a Pesticide Registration Notice within a few months that will require all pesticide registrants to report the presence of any nanomaterials under the FIFRA §6(a)(2) adverse effects reporting requirement.  Trade associations are continuing to work on this issue and have requested clarification regarding EPA’s official “position” on nanotechnology regulation. This will be in continuing development as trade associations discuss the reasoning behind EPA’s decision to incorporate FIFRA §6(a)(2) reporting and potential alternatives that can be used.

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