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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > EPA Updates Information of Nano Regs

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The U.S. Environmental Protection Agency's (EPA) July 7, 2011, Regulatory Agenda contains information of interest to nanotechnology stakeholders. The Regulatory Agenda is a summary of all rulemaking initiatives -- advanced, proposed, and near final -- that EPA has in the pipeline. The document is an excellent resource that lawyers and interested others routinely review to get a sense of what is coming down the pike.

July 20th, 2011

EPA Updates Information of Nano Regs

The U.S. Environmental Protection Agency's (EPA) July 7, 2011, Regulatory Agenda contains information of interest to nanotechnology stakeholders. The Regulatory Agenda is a summary of all rulemaking initiatives -- advanced, proposed, and near final -- that EPA has in the pipeline. The document is an excellent resource that lawyers and interested others routinely review to get a sense of what is coming down the pike.

The current Regulatory Agenda includes several notices concerning nanoscale materials that nano stakeholders may be interested in knowing.

First, EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011. See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201104&RIN=2070-AJ47 for more information.

Second, EPA is developing a Significant New Use Rule (SNUR) for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states "those two efforts were combined into a single rulemaking." EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however. More information on the agenda is available at http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201104&RIN=2070-AJ54

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