USEPA Slated to Propose New Nanomaterial Rules in 2010

This post was written by David Wagner.

Last month, the U.S. Environmental Protection Agency (USEPA) reported in its Unified Agenda that two rules related to nanomaterials may be proposed this year. The first possible regulation is a reporting rule for as yet unspecified nanoscale materials under Section 8 of the Toxic Substances Control Act (TSCA). A notice of this proposed rulemaking is slated for June 2010. The second possible regulation, under Section 4 of TSCA, is a test rule for certain multi-wall carbon nanotubes as well as nanoscale clay and alumina. USEPA reported that notice of the test rule is scheduled to be published in November 2010.

The Unified Agenda, which is published twice a year, provides information about Federal regulatory and deregulatory activities, and includes descriptions about USEPA regulations currently under development or recently completed. 

With respect to the proposed reporting rule for certain nanoscale materials, USEPA reported that the “rule would propose that persons who manufacture these nanoscale materials notify USEPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide USEPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.” 

As for the proposed test rule for certain multi-wall carbon nanotubes and nanosized clays and alumina, USEPA explained that a test rule may be needed to determine the health effects of these materials. It said that “[t]he results of the tests that could be required under this rule would assist USEPA in understanding the health effects of the substance to manage/minimize any potential risk and exposure. Results could also help with establishing a correlation between the chemical/physical properties and health effects needed to protect the health of workers handling the substance.” 

Recent EPA Notice Indicates Intent to Develop a Data Collection Rule for Nanoscale Materials

This post was written by David Wagner.

On August 4, EPA published a report discussing its intent to develop a data collection rule for nanoscale materials under Toxic Substances Control Act’s (TSCA) Section 8(a). Section 8(a) requires certain manufacturers, importers, or processors of a chemical substance to maintain records and submit reports of production and exposure information. 

The report, prepared by the TSCA Interagency Testing Committee (ITC), stated EPA’s intent to develop a proposed TSCA Section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials. The ITC was established to make recommendations to the EPA Administrator regarding chemical substances and mixtures to which EPA should give priority consideration for testing under Section 4 of TSCA, which gives EPA the authority to require chemical manufacturers and processors to test chemical substances and mixtures. 

The report identified the need for additional data for the following nanoscale materials: fullerenes; carbon black; titanium oxide nanowires; titanium oxide nanoparticles; zinc oxide; nanosilver; single–walled carbon nanotubes; multi–walled carbon nanotubes; carbon nanofibers; nanoceramic particles; and nanoclays. The report added that “EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this [report] are either included in [the proposed Section 8(a) rule] or are otherwise new chemical substances subject to premanufacture notification (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA Section 4 rule to develop needed environmental, health, and safety data.” 

Comments on the notice are due by September 3, 2009.