Proposed Federal Regulations Related to Nanomaterials Coming in February?

This post was written by David Wagner.

If the U.S. Environmental Protection Agency (USEPA) stays on schedule, look for February to bring two proposed rules regarding nanomaterials. One proposed rulemaking would establish reporting requirements for certain nanoscale materials. The other proposal is a significant new use rule that would require persons who manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to notify the Agency at least 90 days before they make, import, or use that nanoscale chemical. Both were previewed in USEPA’s FY 2011 Regulatory Agenda.

Proposed Reporting of Nanoscale Materials under TSCA Section 8(a)

Under section 8(a) of the Toxic Substances Control Act (TSCA), this month USEPA plans to propose reporting requirements for persons who are manufacturing, importing, or processing nanoscale materials in commerce. The rule would require these persons to 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 would provide USEPA with an opportunity to evaluate the information and consider additional action under TSCA.

Proposed Significant New Use Rule

Also in February, USEPA intends to propose a significant new use rule (SNUR) under section 5(a)(2) of TSCA that would designate as a significant new use, any use of chemical substances as nanoscale materials after the proposed date of the rule. The SNUR would require persons who manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a notice to the Agency at least 90 days before commencing that activity. The SNUR would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program and other information. The required notification would provide USEPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

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.”