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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.

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Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

1. Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
2. Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
3. Submit material characterization data within six months (see below);
4. Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
5. Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”
 

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

• Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
• Configuration of nanotube ends (e.g., open, capped);
• Description of any branching;
• Width/diameter of inner most wall/tube (average and range);
• Carbon unit cell ring size and connectivity;
• Alignment of nanotube along long axis (straight, bent, buckled);
• Hexagonal array orientation used in the manufacture of the nanotube;
• Particle size of catalyst used in the manufacture of the nanotube;
• Molecular weight (average and range); and
• Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

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