Document ID: EPA-HQ-OPPT-2008-0252-0124
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Multi-Walled Carbon Nanotubes and Single-Walled Carbon Nanotubes
Posted Date: 2010-09-17T04:00Z

[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Rules and Regulations]               
[Page 56880-56889]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se10-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2008-0252; FRL-8835-5]
RIN 2070-AB27

 
Multi-Walled Carbon Nanotubes and Single-Walled Carbon Nanotubes; 
Significant New Use Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under section 
5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical 
substances which were the subject of Premanufacture Notices (PMNs). The 
two chemical substances are identified generically as multi-walled 
carbon nanotubes (MWCNT) (PMN P-08-177) and single-walled carbon 
nanotubes (SWCNT) (PMN P-08-328). This action requires persons who 
intend to manufacture, import, or process either of these two chemical 
substances for a use that is designated as a significant new use by 
this final rule to notify EPA at least 90 days before commencing that 
activity. EPA believes that this action is necessary because these 
chemical substances may be hazardous to human health and the 
environment. The required notification would provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: This final rule is effective October 18, 2010.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2008-0252. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8974; e-mail address: alwood.jim@epa.gov.
     For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use either of the chemical substances contained in 
this final rule: Multi-walled carbon nanotubes (MWCNT) (PMN P-08-177) 
and single-walled carbon nanotubes (SWCNT) (PMN P-08-328). Potentially 
affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of

[[Page 56881]]

entities not listed in this unit could also be affected. The North 
American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether this action 
might apply to certain entities. To determine whether you or your 
business may be affected by this action, you should carefully examine 
the applicability provisions in Sec.  721.5. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.
     This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127: 
see also 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR 
part 707, subpart B). Chemical importers must certify that the shipment 
of the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. In addition, any persons 
who export or intend to export a chemical substance that is the subject 
of this final rule on or after October 18, 2010 are subject to the 
export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What Action is the Agency Taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for two chemical 
substances which were the subject of PMNs. The two chemical substances 
are identified generically (due to confidentiality claims) as multi-
walled carbon nanotubes (MWCNT) (PMN P-08-177) and single-walled carbon 
nanotubes (SWCNT) (PMN P-08-328). This action requires persons who 
intend to manufacture, import, or process either of these two chemical 
substances for an activity that is designated as a significant new use 
by this final rule to notify EPA at least 90 days before commencing 
that activity.
    Previously, in the Federal Register issue of June 24, 2009 (74 FR 
29982) (FRL-8417-6), EPA issued direct final SNURs on these two 
chemical substances (see Sec. Sec.  721.10155 and 721.10156). However, 
EPA received notices of intent to submit adverse comments on these 
SNURs. Therefore, as required by Sec.  721.160(c)(3)(ii), in the 
Federal Register issue of August 21, 2009 (74 FR 42177) (FRL-8433-9), 
EPA withdrew the direct final SNURs on these two chemical substances 
and subsequently proposed SNURs using notice and comment procedures in 
the Federal Register issue of November 6, 2009 (74 FR 57430) (FRL-8436-
8). More information on the specific chemical substances subject to 
this final rule can be found in the direct final or proposed SNURs. The 
record for the direct final and proposed SNURs on these two chemical 
substances was established in the docket under docket ID number EPA-HQ-
OPPT-2008-0252. That docket includes information considered by the 
Agency in developing the direct final rule and this final rule 
including comments on those rules.
    EPA received several comments on the proposed rule. A full 
discussion of EPA's response to these comments is included in Unit V. 
of this document. Based on these comments, EPA is issuing a modified 
final rule on these chemical substances that:
     1. Retains the proposed workplace protection, specific use, 
aggregate manufacturing and importation volume limitations, and release 
to water provisions.
     2. Provides clarification on the exemptions from applicability of 
the SNUR.
     3. Provides additional human health and environmental summary 
information to support EPA's findings under Sec.  721.170(b)(4)(ii) and 
EPA's findings in the proposed rule.
See the proposed rule for a discussion of EPA's findings and 
recommended testing.
    In response to comments on the applicability of the SNURs, EPA 
included in the regulatory text clarifying language for those forms of 
the subject PMN substances which are exempt from the provisions of the 
SNURs. These exemptions apply to quantities of the PMN substances:
      After they have 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.
    In response to comments on the basis for the SNURs, EPA developed 
revised Human Health Effects and Environmental Effects Summaries for 
carbon nanotubes (CNTs). See Unit V. of this document. These summaries 
specify EPA's current hazard concerns as supported by available 
information and data. See Unit X. of this document for a list of those 
sources.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use. Persons who 
must report are described in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same notice requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA may take regulatory action under 
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it 
has received the SNUN. If EPA does not take action, EPA is required 
under TSCA section 5(g) to explain in the Federal Register its reasons 
for not taking action.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C. 
2612) import certification requirements promulgated in Customs and 
Border Patrol regulations at 19 CFR 12.118 through 12.127: see also 19 
CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, 
subpart B). Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA. For importers of chemical substances subject to a final SNUR 
those requirements include the SNUR. In addition, any persons who 
export or intend to export a chemical substance identified in a final 
SNUR are subject to the export notification provisions of

[[Page 56882]]

TSCA section 12(b) (15 U.S.C. 2611 (b)) (see Sec.  721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

III. Rationale and Objectives of the Rule

A. Rationale

     During review of the PMNs submitted for these two chemical 
substances, EPA concluded that regulation was warranted under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), pending the development 
of information sufficient to make reasoned evaluations of the human 
health effects of the chemical substances. 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 including the recent 
modifications to the consent orders. These final SNURs are issued 
pursuant to Sec.  721.160. EPA also finds that, based on the 
environmental effects data, the PMN substances meet the concern 
criteria at Sec.  721.170(b)(4)(ii). See the docket under docket ID 
number EPA-HQ-OPPT-2008-0252 for the corresponding consent orders. For 
additional discussion of the rationale for the SNURs on multi-walled 
carbon nanotubes (MWCNT) (PMN P-08-177) and single-walled carbon 
nanotubes (SWCNT) (PMN P-08-328) see Units II. and V. of this document.

B. Objectives

    EPA is issuing these final SNURs for specific chemical substances 
that have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this final 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.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Inventory. Guidance on how 
to determine if a chemical substance is on the TSCA Inventory is 
available on the Internet at http://www.epa.gov/opptintr/newchems/pubs/
invntory.htm.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
     To determine what would constitute a significant new use for the 
two chemical substances that are the subject of these final SNURs, EPA 
considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, and the four bulleted TSCA section 
5(a)(2) factors listed in this unit.

V. Response to Comments on Proposed SNURs on Multi-Walled Carbon 
Nanotubes and Single-Walled Carbon Nanotubes

    EPA received comments from numerous submitters on the proposed 
rules for MWCNTs that are the subject of PMN P-08-177 and SWCNTs that 
are the subject of PMN P-08-328. A discussion of the comments received 
and the Agency's responses follows.
    Comment 1: The SNURs did not properly identify the chemical 
identity of the substances and the submitter of the PMNs did not claim 
the chemical name of the substances as CBI; therefore there is no basis 
for the use of bona fide procedures under 40 CFR part 721. Further, EPA 
did not give any objective identifying information to identify specific 
substances subject to the SNURs. It was requested that EPA clarify the 
particular chemical identity of the substances covered by these SNURs 
and how users can tell the difference.
    Response: The SNURs for MWCNTs and SWCNTs did properly present the 
chemical identity of the PMN substances. The SNURs contain the same 
objective identifying information as hundreds of previously published 
SNURs where the chemical identity was claimed as CBI. EPA published the 
generic name along with the PMN number to identify that a distinct 
chemical substance was the subject of the PMN without revealing the 
confidential chemical identity of the PMN substance. Because of a lack 
of established nomenclature for CNTs, EPA has allowed PMN submitters to 
represent their CNTs using a name such as CNT, MWCNT, or SWCNT while 
submitting a detailed description of the CNTs using specific structural 
characteristics. In these instances, the PMN submitters claimed those 
specific structural characteristics as CBI. If an intended 
manufacturer, importer, or processor of CNTs is unsure of whether its 
CNTs are subject to this or any other SNUR, the company can either 
contact EPA or obtain a written determination from EPA pursuant to the 
bona fide procedures at Sec.  721.11.
    EPA is using the specific structural characteristics, for all CNTs 
submitted as new chemicals substances under TSCA, to develop standard 
nomenclature for placing these chemical substances on the TSCA 
Inventory. EPA has compiled a generic list of those structural 
characteristics entitled ``Material Characterization of Carbon 
Nanotubes for Molecular Identity (MI) Determination & Nomenclature.'' A 
copy of this list is available in the docket for this SNUR. If EPA 
develops a more specific generic name for these materials, that name 
will be made publicly available.
    Comment 2: Reviewing the proposed SNUR gives the impression that 
EPA considered that MWCNTs and SWCNTs were categories of new substances 
that may present unreasonable risks to human health. EPA informally 
noted that the SNURs apply only to the specific CNTs in the PMNs. It 
appears that EPA has taken the position that some CNTs made by 
different manufacturers are different chemical substances for purposes 
of reporting new chemicals under TSCA. EPA should clarify ``whether the 
SNURs are intended to apply to the PMN substances made by other 
manufacturers.''

[[Page 56883]]

    Response: The SNURs and the findings in the SNURs apply only to the 
specific CNTs that were the subject of PMNs P-08-177 and P-08-328. As 
noted in the public comments to this SNUR, EPA has also received and 
reviewed numerous other new chemical notices for CNTs. EPA acknowledges 
that CNTs made by different manufacturers and processes may be 
considered different chemical substances for purposes of reporting new 
chemical substances under TSCA. EPA will make this determination on a 
case-by-case basis. The Agency will assess and manage the risks of CNTs 
in a similar manner when that assessment is based on similar data. EPA 
may assess and manage CNTs differently as new data becomes available, 
especially in cases where there are new environmental health and safety 
data for specific CNTs.
    Comment 3: Specify how EPA defines CNT chemical identities so that 
downstream users can determine when processing of CNTs sufficiently 
change them so that a new substance is formed that requires new 
chemical notification under TSCA?
    Response: Processing activities that causes a chemical reaction, 
where new chemical bonds are formed, could result in new chemical 
substances reportable under TSCA. However, processing activities that 
change the physical state or physical properties would not result in a 
new chemical substance reportable under TSCA. Companies with specific 
questions for specific materials should contact the Agency for a 
Prenotice Consultation. See http://www.epa.gov/oppt/newchems/pubs/
roster.htm for Agency contact information.
    Comment 4: In some instances companies may not be able to make the 
certifications required to make a bona fide submission and obtain an 
identity determination under Sec.  721.11 for carbon nanotubes.
    Response: Companies that manufacture, import, or process CNTs can 
identify the specific structural characteristics referenced in the 
response to ``Comment 1'' in order to file a bona fide submission. EPA 
recommends that companies that have any questions regarding the 
information required or the need for a bona fide submission for CNTs 
contact the Agency. See http://www.epa.gov/oppt/newchems/pubs/
roster.htm for Agency contact information.
    Comment 5: The SNURs did not include one of the terms included in 
the consent order which exempts from the Order's requirements 
quantities of the PMN substances that have been completely reacted 
(cured). EPA should clarify (1) whether quantities of the PMN 
substances that have been completely reacted (cured) are subject to the 
disposal restrictions in the SNURs; (2) what other terms of the SNURs 
are applicable once the PMN substances have been fixed to a substrate 
or encapsulated within plastic; and (3) applicability of the entire 
SNURs once the PMN substances have been incorporated into an article.
    Response: EPA agrees that all terms of the consent orders should be 
included in the SNURs and has now amended the regulatory text to 
include an exemption from SNUR requirements once the PMN substance has 
been completely reacted or cured. EPA has also developed new, more 
specific language that addresses applicability of the consent orders 
once the PMN substances have been fixed to a substrate or encapsulated 
within a plastic or other matrix. The Agency has included this new 
language in the regulatory text of the SNURs to exempt from SNUR 
requirements PMN substances that have been 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. As stated in Sec.  
721.45(f), once a chemical substance has been incorporated into an 
article the notification requirements of the SNUR do not apply. The 
term ``article'' is defined in 40 CFR 720.3(c).
    Comment 6: The proposed rules do not reference highly controlled 
circumstances of use where exposure criteria are met.
    Response: The rules do not reference exposure criteria or exposure-
based criteria. The rules establish significant new uses that may 
result in changes of the types, forms, magnitude, and duration of 
exposures. A SNUR requires notification before any persons manufacture 
or process for a significant new use so that EPA can evaluate any 
potential exposures and assess potential risks.
    Comment 7: The rules require manufacturers and importers to provide 
testing at a specified production volume.
    Response: The SNURs require notification when a manufacturer or 
importer exceeds a maximum aggregate manufacturing and importation 
volume limit. The 90-day inhalation toxicity study (Harmonized Test 
Guideline 870.3465) is EPA's recommended testing in the proposed SNURs 
preamble. This is the same study required in the TSCA section 5(e) 
consent orders for the PMN substances before the PMN submitter exceeds 
the specified aggregate maximum manufacturing and importation volume. 
Other manufacturers or importers who intend to conduct testing or send 
a SNUN if they believe that they will exceed that limit, are encouraged 
to contact EPA to avoid duplicative testing, to identify alternative 
testing, and to discuss protocols for any testing to be conducted.
    Comment 8: Differences in legislation could result in different 
market situations for companies in the United States and the European 
Union. Emphasis was placed on the utility of taking into account the 
volumes of manufacture or importation of a substance, the potential 
hazard and/or exposures when proposing requirements for generation of 
information on substances. EPA was encouraged to ensure convergence of 
requirements, minimize the economic burden on industry, and the number 
of tests on vertebrate animals through development of tools, especially 
testing approaches and subsequent guidance, under the OECD Working 
Party on Manufactured Nanomaterials.
    Response: EPA agrees with these comments. When considering testing 
requirements, EPA takes into account all of the factors suggested by 
the commenter. However, differences in legislation do result in 
different regulatory situations in each jurisdiction. EPA is committed 
to addressing all of the issues identified by the commenter under the 
Organization for Economic Cooperation and Development (OECD) Working 
Party on Manufactured Nanomaterials. EPA participates in or chairs each 
project in the OECD Working Party.
    Comment 9: EPA should further clarify the meaning of predictable or 
purposeful releases to water. For example, a regulated entity may seek 
to comply with this standard by using a well-designed filtration 
system. Manufacturers and engineers cannot warrant 100% removal. 
Because there is no evidence to believe that trace losses in water may 
cause significant environmental harm, the proposed standard should 
allow for small but arguably predictable losses associated with well 
designed filtration systems without triggering notice obligations. 
Carbon nanotubes occur naturally and are produced from many 
anthropogenic sources, making the proposed rule impractical and 
unenforceable (i.e., one cannot necessarily distinguish between 
incidental carbon nanotubes found in nature and these PMN Substances). 
Adopting a 100% restriction on any arguably predictable loss of the PMN 
Substances under such circumstances

[[Page 56884]]

would impose significant and unnecessary costs on the nation's 
burgeoning nanotechnology industry.
    Response: Purposeful or predictable releases to water include any 
intentional or reasonably foreseeable releases to water from a waste 
stream you identify as part of a manufacturing process or other 
industrial process. For example, when filling out a PMN (EPA Form 7710-
25), submitters are asked to identify environmental releases of the PMN 
substance from their manufacturing process and other known industrial 
processes. Section 5(d) of TSCA, which specifies the required content 
of the PMNs, refers to TSCA section 8(a)(2) which specifies a standard 
of requiring information that is ``known to or reasonably ascertainable 
by'' the PMN submitter. Any water releases of the PMN substance 
identified in the PMN would qualify as purposeful or predictable 
releases. The commenter example, a waste stream subject to water 
filtration before release to water, qualifies as a purposeful or 
predictable release to water.
    Purposeful or predictable releases to water would not include 
accidents or spills. This significant new use designation was not 
intended to prevent every single molecule of a subject chemical 
substance from being released to surface waters. For the uses 
identified in PMNs P-08-177 and P-08-328, EPA did not identify any 
purposeful or predictable releases to water. To prevent any potential 
unreasonable risks, EPA prohibited predictable or purposeful releases 
to water as a restriction in the consent orders and also designated 
such water releases as significant new uses in the SNURs. EPA is 
willing to consider alternatives that establish an acceptable level of 
release to water in these SNURs and future CNT submissions when 
information on the toxicity, exposure, and fate for that specific CNT 
is available. EPA has included a significant new use designation of no 
purposeful or predictable releases to water in SNURs for hundreds of 
PMN substances. EPA will continue this approach on a case-by-case basis 
depending on the findings in the SNUR and the environmental exposures 
identified in the PMN.
    Comment 10: EPA should clarify that the term predictable or 
purposeful releases to waters of the United States does not prevent 
disposal of the PMN substance as a solid waste.
    Response: General SNUR provisions at Sec.  721.3 define the term 
``Waters of the United States'' as having the meaning set forth in 40 
CFR 122.2 which describes surface waters of the United States. This 
does not prevent disposal of the PMN substances as a solid waste in 
landfills or by incineration. In addition, as stated in the response to 
``Comment 5,'' the terms of the SNUR do not apply once the PMN 
substance is completely reacted or 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.
    Comment 11: EPA should clarify what constitutes a dust including if 
the term dust applies only to dry forms and what types of exposure to 
dusts are included.
    Response: The term dust applies to any dry solid particle with a 
size ranging from submicroscopic to macroscopic. It does not apply to 
wet forms. As stated in the terms of the consent orders and SNURs, the 
standard for using the required personal protective equipment is to 
protect anyone who is reasonably likely to be exposed dermally or by 
inhalation to the PMN substance in the form of a dust. It does not 
matter how the dust is generated.
    Comment 12: The Agency did not give an adequate basis for the no-
release-to-water provision. Request the Agency to consider establishing 
a safe level of exposure in water utilizing SNUR provisions in Sec.  
721.90 (b)(2), (b)(3), and (b)(4). Another commenter stated that EPA 
should not issue a SNUR before there is evidence that the PMN substance 
may present an ``unreasonable risk.''
    Response: EPA is not required to make a ``may present unreasonable 
risk'' finding in order to issue a SNUR. As discussed in Unit IV. of 
this document, TSCA section 5(a)(2) describes the factors EPA must 
consider when issuing a SNUR. EPA may issue a SNUR for a new chemical 
substance subject to a TSCA section 5(e) consent order as described at 
Sec.  721.160, or for a new chemical substance that has completed PMN 
review as described at Sec.  721.170, when, respectively, activities 
other than those described in the TSCA section 5(e) consent order or 
the PMN may result in significant changes in human exposure or 
environmental release levels and/or that concern exists about the 
chemical substance's health or environmental effects. See Sec.  
721.170(a).
    The TSCA section 5(e) consent orders for these PMN substances, 
which are the bases for these SNURs, do include a finding that the PMN 
substances may present an unreasonable risk to human health. In 
addition to referencing potential risks to workers exposed by 
inhalation and dermal routes, the consent orders also reference 
potential risks to the general population from exposures via releases 
to water, landfill, or incineration. While the TSCA New Chemicals 
Program's Poorly Soluble Respirable Particles chemical category (see 
``Human Health Effects Summary for CNTs,'' in the response to ``Comment 
13'') does not specifically reference these routes of exposure, EPA 
identified a potential unreasonable risk from these exposures based on 
a lack of environmental fate and exposure data for CNTs to make a 
reasoned evaluation.
    EPA's review of the PMNs did not identify any predictable or 
purposeful releases to water. To prevent any potential unreasonable 
risks, EPA prohibited predictable or purposeful releases to water as a 
restriction in the consent orders and also designated such water 
releases as significant new uses in the SNURs. EPA is willing to 
consider alternatives that establish an acceptable level of release to 
water in a modification to these SNURs and future CNT submissions when 
information on the toxicity, exposure, and fate for that specific CNT 
is available. The response to ``Comment 13'' also contains information 
supporting EPA's environmental effects findings and terms in the 
consent orders and SNURs.
    Comment 13: It was noted that more recent signed and draft consent 
orders contain additional updated hazard assessment information for 
both health and environmental concerns. It was suggested this language 
should be referenced in the final SNURs so that all of EPA's concerns 
are described in a similar manner for all SNURs pertaining to CNTs.
    Response: EPA is continually refining and adding to its risk 
assessment and risk management approaches especially for new chemical 
substances such as CNTs that have limited available hazard, exposure, 
and fate data. Recent consent orders for CNTs do cite additional data 
which was not part of the basis for the consent orders or SNURs for 
these PMN substances, P-08-177 and P-08-328. EPA is incorporating this 
most current language in the next two paragraphs as part of this 
preamble to the final rules. This language does repeat some of the 
information found in the consent order for the PMN substances. EPA has 
also placed, in the reference section of this document (Unit X. of this 
document), and in the docket references to publicly available data on 
the health and environmental effects of CNTs. These data support the 
findings and significant new use designations already made in the rule. 
The environmental effects summary is also being used in CNT consent 
orders to support a finding of

[[Page 56885]]

potential unreasonable risk. EPA also finds that, based on the 
environmental effects data, the PMN substances meet the concern 
criteria at Sec.  721.170(b)(4)(ii).
    ``Human Health Effects Summary for CNTs'': Absorption is expected 
to be poor via all routes for CNTs based on test data for chemicals 
with similar molecular structures and chemicals with similar physical/
chemical properties. Data on other analogous substances indicate the 
potential for generation of increased amounts of respirable or 
absorbable particles during processing and use of nanoscale materials. 
Further evaluation is needed to determine the toxicity of nanoscale 
materials for all routes of exposure. In addition, there are concerns 
for lung effects, based on EPA's Poorly Soluble Respirable Particulates 
chemical category. See www.epa.gov/oppt/newchems/pubs/
cat02.htm#Respirable. Based on test data for analogous chemicals, 
including other CNTs, there are concerns for pulmonary toxicity, 
fibrosis, carcinogenicity, mutagenicity, and immunotoxicity. There are 
also data suggesting that pulmonary deposition of some nanoscale 
materials, including CNTs in the agglomerated form, may induce 
cardiovascular toxicity when these nanoscale materials are inhaled. The 
major health concerns are for potential pulmonary toxicity, fibrosis, 
and cancer to workers exposed via inhalation. Based on the uncertainty 
of the characterization and exposure of nanoscale materials in general, 
there may be additional potential for translocation across the dermis 
and effects on target organs.
    ``Environmental Effects Summary for CNTs'': Toxicity from exposure 
to CNTs has been reported in many aquatic species at concentrations 
that exceed estimated solubility limits. Although CNTs are not 
appreciably water soluble as manufactured, aqueous suspensions can be 
easily formed by reaction with strong acids, ozone, or dispersing 
agents. Recent laboratory research shows that CNTs may be combined with 
dissolved organic matter to form stable aqueous suspensions. To date, 
there is a lack of available studies on CNTs which investigate a broad 
range of production methods, sources, purification, functionalization, 
etc. EPA expects that some fraction of the CNTs, if released into the 
environment, will eventually become suspended in water. Sublethal 
effects, including respiratory stress, ventilation rate, gill mucus 
secretion, gill damage, and aggressive behaviors, have been noted for 
SWCNTs in fish at levels as low as 100 parts per billion (ppb). Liver 
cell injuries were readily apparent at these exposure levels, 
suggesting the possibility of liver tumor formation over longer 
exposure periods. These injuries are notable as the effects were seen 
in cells closest to blood vessels, suggesting transport of respired or 
ingested SWCNTs via the blood stream. Some effects in the gut lumen 
were also observed at these exposure levels. Further studies need to be 
conducted before EPA can establish a concentration of concern. Such 
studies must measure actual concentrations of CNTs and control for the 
effects of contaminants, solvents, and physical factors such as 
blockage of gills or intestines. Before such testing is conducted, 
advanced fate testing may be needed to determine the environmental 
behavior. EPA also finds that, based on the environmental effects data, 
the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).

VI. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    As discussed in the Federal Register issue of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is 
best served by designating a use as a significant new use as of the 
date of publication of the proposed SNUR rather than as of the 
effective date of the final rule. If uses begun after publication were 
considered ongoing, rather than new, it would be difficult for EPA to 
establish SNUR notice requirements because a person could defeat the 
SNUR by initiating the proposed significant new use before the rule 
became effective, and then argue that the use was ongoing as of the 
effective date of the final rule.
    Any person who began commercial manufacture, import, or processing 
of multi-walled carbon nanotubes (PMN P-08-177) or single-walled carbon 
nanotubes (PMN P-08-328) for any of the significant new uses designated 
in the proposed SNUR after the date of publication of the proposed SNUR 
must stop that activity before the effective date of this final rule. 
Persons who ceased those activities will have to meet all SNUR notice 
requirements and wait until the end of the notification review period, 
including all extensions, before engaging in any activities designated 
as significant new uses. If, however, persons who began manufacture, 
import, or processing of either of these chemical substances between 
the date of publication of the proposed SNUR and the effective date of 
this final SNUR meet the conditions of advance compliance as codified 
at Sec.  721.45(h), those persons would be considered to have met the 
final SNUR requirements for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. There are two 
exceptions:
     1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
     2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
 In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) 
listing covering the chemical substance, persons are required only to 
submit test data in their possession or control and to describe any 
other data known to or reasonably ascertainable by them (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In cases where EPA issued a 
TSCA section 5(e) consent order that requires or recommends certain 
testing, see Unit II. of the proposed rule which lists those tests, 
descriptions of tests are provided for informational purposes. EPA 
strongly encourages persons, before performing any testing, to consult 
with the Agency pertaining to protocol selection. To access the 
Harmonized Test Guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.'' The Organisation for Economic Co-operation and 
Development (OECD) test guidelines are available from the OECD Bookshop 
at http://www.oecdbookshop.org or SourceOECD at http://
www.sourceoecd.org.
    In the TSCA section 5(e) consent orders for the two chemical 
substances regulated under this final rule, EPA has established an 
aggregate maximum manufacturing and importation volume limits in view 
of the lack of data on the potential health and environmental risks 
that may be posed by the significant new uses or increased exposure to 
the chemical substances. These limits cannot be exceeded unless the PMN 
submitter first submits the results of toxicity tests that would permit 
a reasoned evaluation of the potential risks posed by these chemical 
substances. Under recent TSCA section 5(e) consent orders, each PMN 
submitter is required to submit each study at least 14 weeks (earlier 
TSCA section 5(e) consent orders required submissions at least 12 
weeks) before reaching the specified production limit. Listings of

[[Page 56886]]

the tests specified in the TSCA section 5(e) consent orders are 
included in the proposed rule for these chemical substances. The SNURs 
contain the same volume limits as the TSCA section 5(e) consent orders. 
Exceeding these production limits is defined as a significant new use. 
Persons who intend to exceed this limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
    The recommended tests may not be the only means of addressing the 
potential risks of the chemical substance. However, SNUNs submitted 
without any test data may increase the likelihood that EPA will respond 
by taking action under TSCA section 5(e), particularly if satisfactory 
test results have not been obtained from a prior PMN or SNUN submitter. 
EPA recommends that potential SNUN submitters contact EPA early enough 
so that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

     As stated in Unit II.C. of this document, according to Sec.  
721.1(c), persons submitting a SNUN must comply with the same notice 
requirements and EPA regulatory procedures as persons submitting a PMN, 
including submission of test data on health and environmental effects 
as described in 40 CFR 720.50. SNUNs must be submitted to EPA on EPA 
Form No. 7710-25 in accordance with the procedures set forth in Sec.  
721.25 and 40 CFR 720.40. This form is available from the Environmental 
Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, 
DC 20460-0001. Forms and information are also available on-line at 
http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements 
for potential manufacturers, importers, and processors of the chemical 
substances during the development of the direct final rule. The 
Agency's complete Economic Analysis is available in the docket under 
docket ID number EPA-HQ-OPPT-2008-0252.

X. References

    The following is a listing of those documents used to prepare the 
preamble to this final rule. A copy of this list is available in the 
docket for this final rule under docket ID number EPA-HQ-OPPT-2008-
0252, which is available for inspection as specified under ADDRESSES.
    1. Baun A, Hartmann NB, Grieger K, and Kusk KO. (2008) Ecotoxicity 
of Engineered Nanoparticles to Aquatic Invertebrates: A Brief Review 
and Recommendations for Future Toxicity Testing. Ecotoxicology. 17:387-
395.
    2. Blaise C, Gagne F, Ferard JF, and Eullaffroy P. (2008) 
Ecotoxicity of Selected Nano-Materials to Aquatic Organisms. 
Environmental Toxicology. 23:591-598.
    3. Bonner JC, et al. (2009) Inhaled multi-walled carbon nanotubes 
stimulate a pleural inflammatory response in the lung of mice. Society 
of Toxicology. Abstract No. 2205.
    4. Cheng J, Flahaut E, and Cheng SH. (2007) Effect of Carbon 
Nanotubes on Developing Zebrafish (Danio rerio) Embryos. Environmental 
Toxicology and Chemistry. 26:708-716.
    5. EPA. (2010) Material Characterization of Carbon Nanotubes for 
Molecular Identity (MI) Determination & Nomenclature. Available in the 
docket under docket ID number EPA-HQ-OPPT-2008-0252.
    6. Farre M, Gajda-Schrantz K, Kantiani L, and Barcelo D. (2009) 
Ecotoxicity and Analysis of Nanomaterials in the Aquatic Environment. 
Analytical and Bioanalytical Chemistry. 393:81-95.
    7. Hubbs A, Mercer RR, Coad JE, and Batelli LA. (2009) Persistent 
pulmonary inflammation, airway mucous metaplasia and migration of 
multi-walled carbon nanotubes from the lung after subchronic exposure. 
The Toxicologist. 108:A2193.
    8. Hyung H, Fortner JD, Hughes JB, and Kim JH. (2007) Natural 
Organic Matter Stabilizes Carbon Nanotubes in the Aqueous Phase. 
Environmental Science & Technology. 41:179-184.
    9. Klaine SJ, Alvarez PJJ, Batley GE, Fernandes TF, Handy RD, Lyon 
DY, Mahendra S, McLaughlin MJ, and Lead JR. (2008) Nanomaterials in the 
Environment: Behavior, Fate, Bioavailability, and Effects. 
Environmental Toxicology and Chemistry. 27:1825-1851.
    10. Lam CW, James JT, McClusky R, and Hunter R. (2004) Pulmonary 
Toxicity of Single-Walled Carbon Nanotubes in Mice 7 and 90 Days after 
Intratracheal Instillation. Toxicological Sciences. 77:126-134.
    11. Landsiedel, et al. (2009) Carbon nanotubes tested in 5- and 90-
day inhalation studies in rats. Society of Toxicology. Abstract No. 
2194.
    12. Ma-Hock L, Treumann S, Strauss V, Brill S, Luizi F, Mertler M, 
Wiench K, Gamer AO, van Ravenzwaay B, and Landsiedel R. (2009) 
Inhalation toxicity of multiwall carbon nanotubes in rats exposed for 3 
months. Toxicological Sciences. 112:468-481.
    13. Mitchell LA, Gao J, Wal RV, Gigliotti A, Burchiel SW, and 
McDonald JD. (2007) Pulmonary and systemic immune response to inhaled 
multiwalled carbon nanotubes. Toxicological Sciences. 100:203-214.
    14. Mouchet F, Landois P, Sarremejean E, Bernard G, Puech P, 
Pinelli E, Flahaut E, and Gauthier L. (2008) Characterisation and in 
vivo ecotoxicity evaluation of double-wall carbon nanotubes in larvae 
of the amphibian Xenopus laevis. Aquatic Toxicology. 87:127-137.
    15. Muller J, Huaux F, Moreau N, Misson P, Heilier J, Delos M, 
Arras M, Fonseca A, Nagy JB, and Lison D. (2005) Respiratory toxicity 
of multi-wall carbon nanotubes. Toxicology and Applied Pharmacology. 
207: 221-231.
    16. Nurkiewicz TR, Porter DW, Hubbs AF, Cumpston JL, Chen BT, 
Frazer DG, and Castranova V. (2008) Nanoparticle inhalation augments 
particle-dependent systemic microvascular dysfunction. Particle and 
Fibre Toxicology. 5:1. Available at http://
www.particleandfibretoxicology.com/content/5/1/1.
    17. Petersen EJ, Huang Q, and Weber Jr WJ. (2008) Ecological Uptake 
and Depuration of Carbon Nanotubes by Lumbriculus variegatus. 
Environmental Health Perspectives. 116:496-500.
    18. Poland CA, Duffin R, Kinloch I, Maynard A, Wallace WAH, Seaton 
A, Stone V, Brown S, MacNee W, and Donaldson K. (2008) Carbon nanotubes 
introduced into the abdominal cavity of mice show asbestos-like 
pathogenicity in a pilot study. Nature Nanotechnology. 3:423-428.
    19. Roberts AP, Mount AS, Seda B, Souther J, Qiao R, Lin S, Ke PC, 
Rao AM, and Klaine SJ. (2007) In vivo Biomodification of Lipid-Coated 
Carbon Nanotubes by Daphnia magna. Environmental Science & Technology. 
41:3025-3029.
    20. Schladweiler, et al. (2009) Single-walled carbon nanotubes 
induced pulmonary and vascular response following intratracheal 
instillation. Society of Toxicology. Abstract No. 2203.

[[Page 56887]]

    21. Shvedova AA, Kisin ER, Mercer AR, Murray AR, Johnson VJ, 
Potapovich AI, Tyurina YY, Gorelik O, Arepalli S, Schwegler-Berry D, 
Hubbs AF, Antonini J, Evans DE, Ku BK, Ramsey D, Maynard A, Kagan VE, 
Castranova V, and Baron P. (2005) Unusual Inflammatory and Fibrogenic 
Pulmonary Responses to Single Walled Carbon Nanotubes in Mice. American 
Journal Physiology Lung Cellular and Molecular Physiology. 10:1152-
1184.
    22. Shvedova AA, Fabisiak JP, Kisin E, Murray AR, Roberts JR, 
Tyurina YY, Antonini JM, Feng WH, Kommineni C, Reynolds J, Barchowsky 
A, Castranova V, and Kagan VE. (2008) Sequential exposure to carbon 
nanotubes and bacteria enhances pulmonary inflammation and infectivity. 
American Journal of Respiratory Cell and Molecular Biology. 38:579-590.
    23. Smith CJ, Shaw BJ, and Handy RD. (2007) Toxicity of Single 
Walled Carbon Nanotubes to Rainbow Trout, (Oncorhynchus mykiss): 
Respiratory Toxicity, Organ Pathologies, and other Physiological 
Effects. Aquatic Toxicology. 82:94-109.
    24. Templeton RC, Ferguson PL, Washburn KM, Scrivens WA, and 
Chandler GT. (2006) Life-Cycle Effects of Single-Walled Carbon 
Nanotubes (SWNTs) on an Estuarine Meiobenthic Copepod. Environmental 
Science & Technology. 40:7387-7393.
    25. Warheit DB, Laurence BR, Reed KL, Roach DH, Reynolds GAM, and 
Webb TR. (2004) Comparative Pulmonary Toxicity Assessment of Single-
wall Carbon Nanotubes in Rats. Toxicological Sciences. 77:117-125.
    26. Wolfarth, MG, et al. (2009) Pulmonary toxicity of multi-walled 
carbon nanotubes. Society of Toxicology. Abstract No. 2196.
    27. Zhu X, Zhu L, Chen Y, and Tian S. (2009) Acute Toxicities of 
Six Manufactured Nanomaterial Suspensions to Daphnia magna. Journal of 
Nanoparticle Research. 11:67-75.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for two new chemical substances 
that were the subject of PMNs and TSCA section 5(e) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR part 9, and included on the related 
collection instrument or form, if applicable. EPA is amending the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this final rule. This listing of 
the OMB control numbers and their subsequent codification in the CFR 
satisfies the display requirements of PRA and OMB's implementing 
regulations at 5 CFR part 1320. This Information Collection Request 
(ICR) was previously subject to public notice and comment prior to OMB 
approval, and given the technical nature of the table, EPA finds that 
further notice and comment to amend it is unnecessary. As a result, EPA 
finds that there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this 
table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of these SNURs will not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is discussed in this unit. The requirement to submit a SNUN 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the final rule as a 
``significant new use.'' Because these uses are ``new,'' based on all 
information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. A SNUR requires 
that any person who intends to engage in such activity in the future 
must first notify EPA by submitting a SNUN. Although some small 
entities may decide to pursue a significant new use in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
over 1,400 SNURs, the Agency receives on average only 5 notices per 
year. Of those SNUNs submitted from 2006-2008, only one appears to be 
from a small entity. In addition, the estimated reporting cost for 
submission of a SNUN (see Unit XI. of this document) is minimal 
regardless of the size of the firm. Therefore, EPA believes that the 
potential economic impacts of complying with these SNURs are not 
expected to be significant or adversely impact a substantial number of 
small entities. In a SNUR that published in the Federal Register issue 
of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its 
general determination that final SNURs are not expected to have a 
significant economic impact on a substantial number of small entities, 
which was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this final rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national

[[Page 56888]]

government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999).

F. Executive Order 13175

    This final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This does 
not significantly or uniquely affect the communities of Indian Tribal 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 9, 2000), do not apply to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use and 
because this action is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9
    Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: September 10, 2010.
Wendy Cleland-Hamnett,
Director, Office of Pollution Prevention and Toxics.

0
 Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. The table in Sec.  9.1 is amended by adding the following sections 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                40 CFR citation                      OMB control No.
------------------------------------------------------------------------
                                * * * * *

------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
                                * * * * *
721.10155......................................                2070-0012
721.10156......................................                2070-0012
                                * * * * *
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  721.10155 to subpart E to 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. 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.

[[Page 56889]]

0
5. Add Sec.  721.10156 to subpart E to read as follows:

Sec.  721.10156  Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting--(1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-08-328) 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.

[FR Doc. 2010-23321 Filed 9-16-10; 8:45 am]
BILLING CODE 6560-50-S