EPA includes single- and multi-walled carbon nanotubes in ‘significant new use’-rule

Released on Wednesday 24th June 2009

The US Environment Protection Agency (EPA) has issues Significant New Use Rules on Certain Chemical Substances (Federal Register, 24th June 2009), including multi-walled carbon nanotubes and single-walled carbon nanotubes.

The notice explains:
‘A. Rationale: During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 23 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.

In the other 19 cases, where the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

B. Objectives: EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:
  • EPA will receive notice of any person’s intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
  • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
  • EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
  • EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.’

The substances included are:

PMN Number P–08–177

Chemical name: Multi-walled carbon nanotubes (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: August 11, 2008. [...]

 

PMN Number P–08–328

Chemical name: Single-walled carbon nanotubes (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: September 15, 2008. [...]

 

The Direct Final Procedures are described as follows:

‘EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), this rule is effective August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 24, 2009, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30–day period for public comment.'

 

Follow this link to download the full federal Register Notice.

 
Related Links:
On the 11th May, the US Environmental Protection Agency (EPA) published notice in its Regulatory Agenda, stating that ‘a TSCA section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.’ (22nd May 2009)
 
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17th November 2008
EPA Threatens Enforcement against Manufacturers of Carbon Nanotubes and Enacts Significant New Use Rules for Two Other Nanoparticles 
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EPA plans stricter manufacturing conditions and data-call in for nanomaterials
In October 2008, the US Environment Protection Agency (EPA) published a notice on the TSCA inventory status of carbon nanotubes and announced that, some time after 1st March 2009, ‘EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes.’ (21st February 2009)

US EPA publishes notice on TSCA inventory status of carbon nanotubes
The US Environmental Protection Agency (EPA) published in the Federal Register a notice entitled ‘Toxic Substances Control Act Inventory Status of Carbon Nanotubes’, giving notice of the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNTs). (31st October 2008)

US EPA publishes scientific evidence on carbon nanotube inhalation studies
BASF Corporation submitted to the US Environment Protection Agency (EPA) (under Section 8(e) of the Toxic Substances Control Act (TSCA)) results of ‘A Subchronic Inhalation Study in Wistar Rats with Carbon Nano Tube’. (31st October 2008)

 

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