In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".
This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:
Sec. 721.10155 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j) and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
The language affecting SWCNTs is the same.
Following receipt of a notice to file adverse comments, EPA withdrew the SNURs affecting MWCNTs and SWCNTs on 08/21/2009. A proposed final rule was published in the Federal Register on 11/06/2009. This proposed rule retained the language of the original direct rule while also adding new language regarding the release of the MWCNTs and SWCNTs into water. The added language is italicized and bolded below.
Sec. 721.10155 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
Again, the language for SWCNTs was the same.
After receiving and reviewing comments submitted by the public about the proposed rule, EPA added more new language clarifying that the requirements of the rule didnot apply after the substances had been cured, incorporated or embedded into a polymer matrix that had been cured or is a solid that will not undergo anymore chemical processing. Again, the added language is italicized and bolded below.
Sec. 721.10155 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting–(1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the chemical substance after it has been completely
reacted (cured); incorporated or embedded into a polymer matrix that
itself has been reacted (cured); or embedded in a permanent solid
polymer form that is not intended to undergo further processing except
for mechanical processing.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tightfitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
EPA has issued these final SNURs to achieve four objectives:
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.
In the review of the comments received in response to the proposed final rule, EPA specifies that these SNURs apply only to "the specific CNTs that were the subject of PMNs P-08-177 P-08-328. . . . EPA acknowledges that CNTs made by different manufacturers and processes may be considered different substances for purposes of reporting new chemical substances under TSCA. EPA will make this determination on a case-by-case basis." Other comments filed focused on what the commenters contend is the near impossibility of achieving 100% filtration of CNTs from the waste streams produced by manufacturing or processing of these substances and discharged into U.S. waters.
This rule comes into effect on 10/18/2010. To read the comments submitted and supporting materials, please go here.
