[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Proposed Rules]
[Page 57430-57436]
[DOCID:fr06no09-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0252; FRL-8436-8]
RIN 2070-AB27

Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing 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.
The two substances are identified generically as multi-walled carbon
nanotubes (P-08-177) and single-walled carbon nanotubes (P-08-328).
These substances are subject to TSCA section 5(e) consent orders issued
by EPA. The consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
proposed SNURs on these substances are based on and consistent with the
provisions in the underlying consent orders. The proposed SNURs
designate as a ``significant new use'' the absence of the protective
measures required in the corresponding consent orders. This action
would require persons who intend to manufacture, import, or process
either of these two substances for an activity that is designated as a
significant new use by this proposed rule to notify EPA at least 90
days before commencing that activity. 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: Comments must be received on or before December 7, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0252, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania

Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2008-0252. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0252. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: 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., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically 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<PHONE_NUMBER>, 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 general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    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:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
     Manufacturers, importers, or processors of one or both
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 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
and 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 a final SNUR 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 proposed rule on or after December 7, 2009 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.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.

    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing significant new use rules (SNURs) under section
5(a)(2) of TSCA for two chemical substances which were the subject of
premanufacture notices (PMNs). The two substances are identified
generically as multi-walled carbon nanotubes (P-08-177) and single-
walled carbon nanotubes (P-08-328). These substances are subject to
TSCA section 5(e) consent orders issued by EPA, which require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs on these substances are
based on and consistent with the provisions in the underlying consent
orders. The proposed SNURs designate as a ``significant new use'' the
absence of the protective measures required in the corresponding
consent orders. These SNURs would require persons who intend to
manufacture, import, or process either of these two substances for an
activity that is designated as a significant new use to notify EPA at
least 90 days before commencing that activity.
    In the Federal Register of June 24, 2009 (74 FR 29982) (FRL-8417-
6), EPA issued direct final SNURs on these two substances in accordance
with the procedures at Sec.  721.160(c)(3)(i). EPA received a notice of
intent to submit adverse comments on these SNURs. Therefore, as
required by Sec.  721.160(c)(3)(ii), in the Federal Register of August
21, 2009 (74 FR 42177) (FRL-8433-9), EPA withdrew the direct final
SNURs and is now issuing this proposed rule on the two substances. The
record for the direct final SNURs on these substances was established
as docket EPA-HQ-OPPT-2008-0252. That record includes information
considered by the Agency in developing the direct final rules and the
notice of intent to submit adverse comments.

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. The mechanism
for reporting under this requirement is established under 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.
1612) import certification requirements promulgated at 19 CFR 12.118
through 12.127, and 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 chemical substances subject
to a final SNUR must certify their compliance with the SNUR
requirements. 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 TSCA section 12(b) (15 U.S.C. 2612 (b)) (see
Sec.  721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

III. 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 proposed SNURs,
EPA considered relevant information about the toxicity of the chemical
substances, likely human exposures and environmental releases
associated with possible uses, and the above four factors listed in
TSCA section 5(a)(2).

IV. Substances Subject to this Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping
requirements for two chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name if the specific name is
claimed as CBI).
     CAS number (if assigned for non-confidential chemical
identities).
     Basis for the TSCA section 5(e) consent order.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
     CFR citation assigned in the regulatory text section of
this proposed rule.
    The regulatory text section of this proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production limits and other uses designated in this

proposed rule, may be claimed as CBI. Unit VIII. discusses a procedure
companies may use to ascertain whether a proposed use constitutes a
significant new use.
    This proposed rule concerns two PMN substances that are subject to
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I)
where EPA determined that activities associated with the PMN substances
may present unreasonable risk to human health. Those consent orders
require protective measures to limit exposure or otherwise mitigate the
potential unreasonable risk. The so-called proposed ``5(e) SNURs'' on
these PMN substances are issued pursuant to Sec.  721.160, and are
based on and consistent with the provisions in the underlying consent
orders. The proposed 5(e) SNURs would designate as a ``significant new
use'' the absence of the protective measures required in the
corresponding consent orders.
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: September 1, 2009
(amended).
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a property
modifier in electronic applications and as a property modifier in
polymer composites. The order was issued under sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous
respirable, poorly soluble particulates and on other carbon nanotubes
(CNTs), EPA believes that the PMN substance may cause lung effects. To
protect against this risk, the consent order requires use of a National
Institute for Occupational Safety and Health (NIOSH)-approved full-face
respirator with N-100 cartridges. Based on physical properties of the
PMN substance, EPA believes it may cause health effects via dermal
exposure. To protect against this risk, the consent order requires that
workers wear gloves and protective clothing impervious to the chemical
substance. The consent order also prohibits any predictable or
purposeful release of the PMN substance into the waters of the United
States. The proposed SNUR would designate as a ``significant new use''
the absence of these protective measures.
Toxicity concern: There is a concern for lung health effects based on
data for poorly soluble particulates and for other CNTs, and for lung
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study in rats (OPPTS Harmonized Test Guideline
870.3465 or Organisation for Economic Co-operation and Development
(OECD) 413 test guideline) with a post exposure observation period of
up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis;
and certain material characterization data would help characterize
possible effects of the PMN substance. In the consent order, the PMN
submitter has agreed not to exceed a specified production volume or
production time limit (whichever comes first) without performing these
tests.
CFR citation: 40 CFR 721.10155.
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 1, 2009
(amended).
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a property
modifier in electronic applications and as a property modifier in
polymer composites. The order was issued under sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous
respirable, poorly soluble particulates and on other carbon nanotubes
(CNTs), EPA believes that the PMN substance may cause health effects.
To protect against this risk, the consent order requires use of a
NIOSH-approved full-face respirator with N-100 cartridges. Based on
physical properties of the PMN substance, EPA believes it may cause
health effects via dermal exposure. To protect against this risk, the
consent order requires that workers wear gloves and protective clothing
impervious to the chemical substance. The consent order also prohibits
any predictable or purposeful release of the PMN substance into the
waters of the United States. The proposed SNUR would designate as a
``significant new use'' the absence of these protective measures.
Toxicity concern: There is a concern for health effects based on data
for poorly soluble particulates and for other CNTs, and for lung
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study in rats (OPPTS Harmonized Test Guideline
870.3465 or OECD 413 test guideline) with a post exposure observation
period of up to 3 months, including BALF analysis; and certain material
characterization data would help characterize possible effects of the
PMN substance. In the consent order, the PMN submitter has agreed not
to exceed a specified production volume or production time limit
(whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10156.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for these two chemical
substances, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the human health 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 proposed 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
proposed SNURs are issued pursuant to Sec.  721.160.

B. Objectives

    EPA is proposing these 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 proposed rule:
     EPA would 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 would 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 would 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 would 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.

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

    To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this proposed
rule have undergone premanufacture review and are subject to TSCA
section 5(e) consent orders. The PMN submitters are prohibited by these
TSCA section 5(e) consent orders from undertaking activities which EPA
is proposing as significant new uses. EPA solicits comments on whether
any of the uses proposed as significant new uses are ongoing.
    As discussed in the Federal Register 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 rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule 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 significant new use
before the rule became final, and then argue that the use was ongoing
before the effective date of the final rule. Thus, persons who begin
commercial manufacture, import, or processing activities with the
chemical substances that would be regulated as a ``significant new
use'' through this proposed rule, must cease any such activity before
the effective date of the rule if and when finalized. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under Sec.  721.45(h), the person
would be considered exempt from the requirements of the SNUR.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN, except where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)). 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 Sec.
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, Unit IV. 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. Many OPPTS Harmonized Test Guidelines are now
available on the Internet. Please go to http://www.epa.gov/oppts and
select ``Test Methods and Guidelines'' on the left-side navigation
menu. 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 proposed rule, EPA has established
production volume limits in view of the lack of data on the potential
health 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 the tests specified in the TSCA section 5(e) consent orders
are included in Unit IV. The SNURs contain the same production 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 the production 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 for
significant new uses without any test data may increase the likelihood
that EPA will take 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. Procedural Determinations

    By this action, EPA is proposing certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final
determination or other disposition of the confidentiality claim under
40 CFR part 2 procedures, EPA is required to keep this information
confidential. EPA promulgated a procedure to deal with the situation
where a specific significant new use is CBI. This rule cross-references
Sec.  721.1725(b)(1) and is similar to that in Sec.  721.11 for
situations where the chemical identity of the chemical substance
subject to a SNUR is CBI. This procedure is cross-referenced in each
SNUR that includes specific significant new uses that are CBI.
    Under these procedures a manufacturer, importer, or processor may
request EPA to determine whether a proposed use would be a significant
new use under the rule. The manufacturer, importer, or processor must
show that it has a bona fide intent to manufacture, import, or process
the chemical substance and must identify the specific use for which it
intends to manufacture, import, or process the chemical substance. If
EPA concludes that the person has shown a bona fide intent to
manufacture, import, or process the chemical substance, EPA will tell
the person whether the use identified in the bona fide submission would
be a significant new use under the rule. Since the chemical identities
of the chemical substances subject to these SNURs are also CBI,
manufacturers, importers, and processors can combine the bona fide
submission under the procedure in Sec.  721.1725(b)(1) with that under
Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission

would not be a significant new use, i.e., the use does not meet the
criteria specified in the rule for a significant new use, that person
can manufacture, import, or process the chemical substance so long as
the significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

IX. SNUN Submissions

    As stated in Unit II.C., 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 Sec.
720.50. SNUNs must be mailed to the Environmental Protection Agency,
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see Sec.  Sec.  721.25 and
720.40). Forms and information are also available electronically at
http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

X. 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 public docket.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several 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 the 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 would amend the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed 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 would 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 would 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 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 1,000 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 IX.) is minimal regardless of the size of the firm. Therefore, 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 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 would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would 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 would not have a substantial direct effect on States,
on the relationship between the national 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly or uniquely affect the
communities of Indian Tribal governments, nor would 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 proposed 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 proposed rule 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).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: October 26, 2009.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as
follows:

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

    2. By adding new 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.
    (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.
    3. By adding new 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.
    (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.

[FR Doc. E9-26818 Filed 11-5-09; 8:45 am]

BILLING CODE 6560-50-S