[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Rules and Regulations]
[Pages 38210-38223]
[FR Doc No: 2013-15032]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-0279; FRL-9390-6]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 17
chemical substances which were the subject of premanufacture notices
(PMNs). Fifteen of these chemical substances are subject to TSCA
section 5(e) consent orders issued by EPA. This action would require
persons who intend to manufacture, or process any of these 17 chemical
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: This final rule is effective August 26, 2013.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2010-0279, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OPPT Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Alwood, Chemical Control Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use any of the 17 chemical substances contained in this
final rule. Potentially affected entities may include, but are not
limited to:
     Manufacturers, or processors of the 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;
see also 19 CFR 127.28. 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. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance that is the subject of this final rule 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 17 chemical
substances which were the subject of PMNs. Fifteen of these chemical
substances are subject to TSCA section 5(e) consent orders issued by
EPA. The final SNURs for these substances are based on and consistent
with the provisions in the underlying consent order. The final SNURs
designate as a significant new use manufacture (including import) or
processing in the absence of the protective measures required in the
corresponding consent order. The final SNURs for the 2 remaining
substances are not subject to a consent order under TSCA section 5(e).
In these two cases, EPA has determined in the final SNURs that these
significant new use activities, ``(i) are different from those
described in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and (ii) may be accompanied by changes in
exposure or release levels that are significant in relation to the
health or environmental concerns identified'' for the PMN substance.
This action requires persons who intend to manufacture, or process
these 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 December 28, 2011 (76
FR 81447) (FRL-9326-2), EPA proposed SNURs for these seventeen chemical
substances. More information on the specific chemical substances
subject to this final rule can be found in the Federal Register
documents proposing the SNURs. The record for the SNURs for these
seventeen chemical substances was established in the docket under
docket ID number EPA-HQ-OPPT-2010-0279. That docket includes
information considered by the Agency in developing the proposed and
final rules, including comments on those rules.
    EPA received numerous 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 modified
final rules for these chemical substances as described in Unit V. of
this document.

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,
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 final 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.

III. Rationale and Objectives of the Final Rule

A. Rationale

    During review of the PMNs submitted for these chemical substances,
EPA concluded that for 15 of the 17 chemical substances, regulation was
warranted under TSCA section 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, a
TSCA section 5(e) consent order requiring the use of appropriate
exposure controls was negotiated with

the PMN submitter. The SNUR provisions for these chemical substances
are consistent with the provisions of the TSCA section 5(e) consent
order. These final SNURs are issued pursuant to Sec.  721.160. See the
docket under docket ID number EPA-HQ-OPPT-2010-1075 for the
corresponding consent orders.
    In the other two cases, where the uses were not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec.  721.170 were met. For
additional discussion of the rationale for the SNURs on these
chemicals, see Units II. and V. of the proposed rule.

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, 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,
or processing a listed chemical substance for the described significant
new use.
     EPA will be able to regulate prospective manufacturers, 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, 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/existingchemicals/pubs/tscainventory/index.html.

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
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, taking into consideration the four bulleted TSCA section
5(a)(2) factors listed in this unit.

V. Response to Comments on Proposed SNURs

    Comment 1: One commenter stated that the practice of EPA
negotiating consent orders with the PMN submitter first without public
comment or input has limited the public's ability to use the comment
process to change requirements for SNURs based on consent orders and
has contributed to SNURs requiring personal protective equipment rather
than following the industrial hygiene hierarchy of controls where
personal protective equipment is the last option selected to control
exposures.
    EPA Response: EPA issues orders under section 5(e) of TSCA in
response to PMNs submitted under Section 5(a) of TSCA. EPA can only
negotiate consent orders with persons who submitted the PMN. Because
the consent order only restricts the activities of the PMN submitter,
EPA issues a SNUR to extend the same requirements to all manufacturers,
and processors. SNURs are issued either using notice and comment
rulemaking or as direct final rules. Regardless of which procedure is
used, the public is permitted an opportunity to comment. In accordance
with the procedural rules for promulgating SNURs based on section 5(e)
orders (see 40 CFR 721.160(b)), such SNURs are generally based on and
consistent with the underlying section 5(e) consent order. However, EPA
may also designate additional activities as significant new uses
(SNUs). These additional SNUs may be in response to public comment. For
an example, see the response to Comment 14.
    Comment 2: A commenter objected to the requirement that domestic
manufacture of certain PMN substances is not permitted. The commenter
states that if it is unacceptable for Americans to be exposed to these
substances, then it is unacceptable for other humans to be exposed.
Conversely, the commenter stated that if these substances can be
manufactured safely then Americans should also have that opportunity.
    EPA Response: The SNUR does not prevent domestic manufacture from
occurring, it only requires notification beforehand. Because domestic
manufacture is not currently anticipated and may never occur, EPA does
not review potential risks associated with domestic manufacture when a
PMN is submitted with an indication that the substance will only be
imported and not domestically manufactured. EPA did not review or
address potential risks of manufacture outside the United States
because the statutory authority of TSCA is not applicable to actions
outside the United States. If and when a person decides to begin
domestic manufacture of the substance, the SNUN review will then permit
EPA to assess and address potential risks associated with the SNU
before they occur.
    Comment 3: For the SNUR for the chemical substance which was the
subject of PMN P-04-244, one commenter stated that there was no need
for a production volume limit for the SNUR, based on the limited use of
the PMN substance as a herbicide intermediate, minimal toxicity
effects, and the use of personal protective equipment to limit
exposures. Another commenter, who is subject to the consent order,
stated that they would petition the Agency to eliminate the testing
requirement in the consent order. The second commenter recommended that
EPA finalize the SNUR after the agency takes action on the petition.
    EPA Response: The consent order requires testing at a specific
production volume limit, which is the basis for the production volume
limit of manufacture of the PMN substance contained in the SNUR at
Sec.  721.80(q). After reviewing the petition to modify the consent
order, EPA decided to retain the testing requirement in the consent
order, because the petitioner did not submit alternative data that
addressed the testing requirement in the consent order. EPA retained
the testing requirement in the consent order at a

specific production volume limit to address EPA's finding that the
available information is insufficient to permit a reasoned evaluation
of the health effects of the PMN substance at larger production
volumes. Thus, the final rule will contain the same production volume
limit for manufacture. If the person subject to the consent order
submits the required testing before exceeding the production volume
limit, that person is permitted to exceed the production volume limit
without a significant new use notification. EPA will review the testing
results and take appropriate action to continue to address any
potential unreasonable risks. Processors of the PMN substance are not
subject to the production volume limit.
    Comment 4: EPA should make it clear to PMN submitters of carbon
nanotubes and other nanomaterials that required test methods will be
decided on a case-by-case basis and that preference will be given to in
vitro nanomaterial-specific methods. There are several EPA and National
Academy of Science testing strategies that support this approach. In
addition to problems with extrapolating information from animal studies
to humans for conventional chemicals, nanomaterials possess unique
physical and toxicological properties that render animal testing even
more problematic. It is critical to completely and accurately
characterize nanomaterials and then apply in vitro and in silico
methods within an integrated test strategy. In the event that
additional data is requested, EPA should require manufacturers to use
high-throughput methods that have been specifically designed for
nanomaterials in order to reduce reliance on animal-based testing.
    EPA Response: EPA identified recommended testing in the preamble of
the proposed SNUR. Any manufacturers, or processors who intend to
conduct testing or submit a SNUN are encouraged to contact EPA prior to
commencing testing to avoid duplicative testing, to identify
alternative testing, and to discuss protocols and testing strategies
for any testing to be conducted. EPA recognizes the potential value of
high-throughput methods, in vitro nanomaterial specific methods, and
integrated testing strategies for nanomaterials. EPA continues to
evaluate proposed testing methods for carbon nanotubes and other
nanomaterials. In assessing this on a case-by-case basis, EPA will
continue to consider the alternatives identified by the commenter.
    Comment 5: The chemical name for P-10-476 should include the word
brominated.
    EPA Response: EPA agrees that brominated is part of the chemical
name and will include the corrected chemical name in the final SNUR.
    Comment 6: All data regarding environmental and health effects of
nanomaterials, especially adverse effects, should be made publicly
available. EPA must challenge claims of confidential business
information (CBI) by manufacturers. EPA could disclose CBI in
connection with a public proceeding to determine whether a nano product
causes unreasonable adverse effects on health or the environment, if
EPA finds such disclosure is necessary in the public interest.
    EPA Response: EPA is committed to ensuring that CBI claims do not
limit the public availability of environmental and health effects data
beyond the confidentiality protections provided in TSCA Section 14. EPA
has well established provisions that provide, as appropriate, a
mechanism to evaluate CBI claims to ensure such claims are consistent
with the statute. Regarding the chemical substances that are
nanomaterials and intended to be subject to the proposed SNUR, each
consent order and SNUR clearly articulates the basis for EPA's findings
and describes the data used to assess health and environmental effects
and risks. Moreover there were no CBI claims for health and safety data
in the health and safety studies for the substances subject to the
proposed SNUR.
    Comment 7: The proposed regulations fail to address a number of
concerns including addressing the public's and worker's right to know
by not providing for mandatory nano-specific ingredient and warning
labeling requirements.
    EPA Response: The SNURs and the consent orders which are the basis
for the SNURs do not require labeling of nano-specific ingredients or
nano-specific warnings because (1) the basis for the consent orders and
SNURs is not that they are nanomaterials per se, but rather is based on
their specific properties and potential risks, and (2) companies that
manufacture, process, and use chemical substances that are carbon
nanotubes and fullerenes already clearly identify those chemical
substances as nanomaterials.
    Comment 8: The requirements for the proposed SNURs for P-09-54-57
and P-09-142-144 were inconsistent with requirements in the consent
order. Specifically, the proposed SNURs required Sec.
721.63(a)(2)(ii), which is full body protective clothing, when the
consent orders required clothing that covers any other exposed areas of
the arms, legs, and torso. In addition, for P-09-55, the proposed SNUR
includes language that respirators must be used ``with an assigned
protection factor (APF) of at least 50''. The consent order for P-09-55
does not contain language requiring a respirator with an APF of 50.
    EPA Response: Because the use of clothing that covers any other
exposed areas of the arms, legs, and torso, as required by the consent
orders for the PMN substances, is an ongoing use, the proposed SNUR
requirements have been changed in the final rule to be consistent with
the ongoing use. In the final rule, EPA has changed the requirements in
Sec.  721.63 to require clothing that covers any other exposed areas of
the arms, legs, and torso for these SNURS. Because the consent order
for P-09-54-57 does not require that the PMN submitter demonstrate that
the clothing is impervious, the SNUR has been revised accordingly to
reflect the ongoing use. However, the consent order for P-09-142-144
does require that the PMN submitter demonstrate that the protective
clothing is impervious. Therefore, EPA will retain the language in the
final rules for P-09-142-144 that imperviousness must be demonstrated
for the clothing. EPA incorrectly included in the proposed rule for P-
09-55 in Sec.  721.63 the language, ``with an assigned protection
factor (APF) of at least 50''. EPA removed that language for P-09-55 in
the final rule.
    Comment 9: NIOSH recommends a hierarchical approach to reduce
worker exposure that relies on respiratory protection only after other
approaches have been attempted. The proposed rules allow persons who
would be subject to SNURs for CNT to submit data to EPA in support of a
New Chemical Exposure Limit (NCEL) under 40 CFR 721.30. The following
comments pertain primarily to the CNT chemical substances in the
proposed SNURS. To ensure that the PMN substances that are CNT are
handled in a safe manner, EPA may want to add a requirement that
employers submit information about specific workplace exposure controls
in addition to the supporting evidence of airborne exposure data. EPA
should also consider providing guidance on methods to measure process
emissions and worker exposures, and interpretation of those data in
making risk management decisions. NIOSH has published guidance on
general approaches as well as specific CNT information. The basis of
any NCEL should be compatible with current United States government
risk assessment policies and practices used to set occupational
exposure limit. NIOSH recommends that EPA use the

NIOSH REL of 1 ug/m\3\ as an 8 hour-time-weighted average as identified
in its final CNT bulletin. This would be an interim recommendation for
controlling workplace exposures, until results of ongoing research can
elucidate which physical and chemical characteristics of CNT affect
their toxicity and until improved methods to measure airborne exposures
are established.
    EPA Response: EPA agrees that a hierarchy of controls should be
applied and that personal protective equipment is the last resort to
prevent exposures. See EPA's response to comment 14 describing language
it will add to the applicable SNURs in this action. EPA's NCELs
language in consent orders states that preventing exposures is the
preferred method for protecting workers, see: http://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf. Most PMN and SNUN submissions
describe engineering controls and other steps that will be taken to
reduce worker exposures. However, in many cases these measures may not
sufficiently reduce exposures or may not used by every manufacturer or
processor. EPA requires personal protective equipment for workers who
are reasonably likely to be exposed in order to prevent unreasonable
risks. However, persons subject to the SNURs for carbon nanotubes may
submit information under 40 CFR 721.30 on any alternative exposure
controls, including a NCEL, to support a determination that those
exposure controls are equivalent to the requirements in the SNUR. While
EPA encourages submission of as much information as possible to support
that determination, EPA does not require submission of specific
workplace exposure controls in addition to airborne exposure data. EPA
can provide information on the approach used to measure releases and
exposures on a case-by-case basis to support a determination that those
exposure controls are equivalent to the requirements in the SNUR. Such
information would take into consideration the fact that new chemical
substances do not have established methods of detection. When
establishing a NCEL or other alternative exposure control, EPA will
consider all available data including United States government policies
and practices used to set occupational exposure limits. Because of the
uncertainty surrounding the NIOSH REL of 1 ug/m\3\ (as NIOSH noted in
its final CNT bulletin the REL is based on the current analytical limit
of quantification and may not be preventative of all known health
effects see: http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf),
EPA will not adopt the NIOSH REL as a NCEL at this time because EPA
cannot determine that at the REL the potential exposures may not
present an unreasonable risk. EPA will consider the final NIOSH REL or
other alternative exposure controls for CNTs if a submission requesting
such is made under 40 CFR 721.30. This would allow the submitter to
send EPA data in support of a proposed exposure level and to
demonstrate a technique to comply with that level. EPA would then
evaluate the proposal and data as described in 40 CFR 721.30. See:
http://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf and
http://www.epa.gov/oppt/newchems/pubs/ncelresp.pdf, which,
respectively, are EPA's boilerplate TSCA 5(e) consent order containing
a NCEL and EPA's Response to Comments on NCELs in TSCA 5(e) Orders.
These two documents contain additional information on EPA's approach to
NCELs and developing techniques to comply with those requirements.
    Comment 10: Each CNT SNUR includes a statement that this rule does
not apply `` . . . to quantities of the PMN substance after they have
been completely reacted (cured); embedded or incorporated in a polymer
matrix . . . that is not intended to undergo further processing, except
for mechanical processing.'' NIOSH agrees with this approach. The
wording in Sec.  721.10274 of the proposed rule (page 81460) differ
from that in other sections by stating ``. . . or embedded in a
permanent solid polymer form with a concentration of the PMN substance
equal to or below 30 percent. The other sections did not include the
``30 percent'' requirement. Please clarify the basis for EPA's
determination for this particular PMN substance.
    EPA Response: Based on confidential information in the PMN, EPA
determined, that for this PMN substance, P-09-0188, there may not be an
unreasonable risk if the PMN substance was contained in a polymer form
with a concentration of the PMN substance equal to or below 30 percent;
however, EPA is concerned about potential risks above a 30 percent
concentration. Consequently, the consent order does not apply when the
concentration of the PMN substance is equal to or below 30 percent in a
permanent solid polymer form.
    Comment 11: The proposed rules for the carbon nanotube chemical
substances include statements requiring PMNs to include 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, and the reasonably
anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of a chemical substance. A
change in these factors may not necessarily address potential risk to
workers.
    EPA Response: These comments pertain to the four factors identified
in section 5(a)(2) of TSCA that EPA must consider when determining
significant new uses of a chemical substance. EPA must also consider
all other relevant factors. These factors are not requirements for
information that must be included in PMNs or SNUNs. EPA agrees that a
change in these factors does not necessarily result in a risk to human
health or the environment. Persons who intend to manufacture, or
process chemical substances for an activity that is designated as a
significant new use by this final rule must notify EPA at least 90 days
before commencing that activity. This required significant new use
notification would provide EPA with the opportunity to evaluate the
intended new use and to prohibit or limit any activity associated with
the new use. EPA would assess the potential risks from those new uses
and take action to prevent any unreasonable risks to human health or
the environment from activities described in the SNUN.
    Comment 12: One commenter stated that the proposed SNURs for the
carbon nanotubes restrict the uses of the PMN substances to those
specified in the consent order and require certain dermal and
respiratory personal protective equipment. Submission of a PMN or SNUN
will allow EPA to review these chemical substances but would not
address worker safety as the notices would not require reporting of
information relevant to risk assessment. There are several
uncertainties associated with risk assessment of nanomaterials
including a lack of reliable studies, smaller particles may have more
detrimental and more potent effects, and smaller particles may cause
different or greater exposures to humans and the environment. Because
of these uncertainties, risk assessment of nanomaterials will not be
adequate.
    EPA Response: Despite the uncertainties cited by the commenter, EPA
believes that its assessment and risk management of nanomaterials,
although sometimes hampered by a lack of submitted data, is adequate to

identify and prevent potential unreasonable risks to human health or
the environment from manufacturing processing, and using nanomaterials
including risks to workers . EPA has consistently limited exposures to
and releases of nanomaterials that are new chemical substances to
prevent unreasonable risks through the use of TSCA section 5(e) orders
and SNURs.
    Comment 13: The SNURs for the carbon nanotubes should require
reporting of risk assessment methods and findings, including
nanoparticle dimension and relevant information. Personal protective
equipment should be required as the last step in risk management. The
SNURs should also require some form of engineering and administrative
controls on top of the required personal protective equipment with
exhaust ventilation systems designed, tested, and maintained as per the
recommendations of the American Conference of Governmental Industrial
Hygienists and requiring ongoing risk monitoring.
    EPA Response: If a manufacturer or processor wants to engage in one
of the new uses, the submitter of the SNUN must report all test data
that are in the possession or control of the submitter as well as all
other data concerning health or environmental effects known or
reasonably ascertainable by the submitter, as described in 40 CFR
720.45 and 40 CFR 721.25. Risk assessment methods and findings are not
specifically required in these regulations to be submitted in a SNUN
and EPA has not required them for other SNUNs because they are not
statutorily required to be submitted for section 5 notices under TSCA
Section 5(d)(1). However, pursuant to TSCA Section 5(d)(1)(B),
available information relevant to potential hazards and risks must be
included in a SNUN and could include any relevant risk assessment
findings that have been developed by the SNUN submitter. For example,
SNUN submitters should report any available particle size data for
carbon nanotubes. The SNURs allow for specific engineering and
administrative controls proposed by a submitter under 40 CFR 721.30,
once EPA has evaluated those controls. See also the responses to
comments 9 and 14 for further discussion of engineering and
administrative controls.
    Comment 14: EPA received a similar set of comments from 26 public
submissions. Each of these comments generally stated that EPA's
approach to exclusively requiring personal protective equipment in
SNURs to prevent worker exposure instead of requiring engineering
controls is not following the best occupational health and safety
practices. The commenters suggest approaches that EPA could adopt.
Several commenters identified the ``hierarchy of controls'' approach
for industrial hygiene and workplace safety and controls, where
elimination, substitution, engineering controls, and workplace or
administrative controls should be used before personal protective
equipment. Several commenters stated that persons subject to the SNUR
should follow the OSHA requirements that a hierarchy of controls is
required before employers use personal protective equipment. Some
commenters suggest that EPA should specifically incorporate OSHA
requirements at 40 CFR 1910.134(a)(1) into each SNUR or modify
requirements in the SNUR at Sec.  721.63 to require a hierarchy of
controls. Several commenters also suggested that EPA incorporate into
SNURs applicable to CNT the recommendations in NIOSH Current
Intelligence Bulletin for CNT. Other commenters noted that a NIOSH
Progress Toward Safe Nanotechnology publication, a 2006 Rand Report
summarizing a 2005 workshop, EPA's Nanotechnology White Paper, a NIEHS
report on training workers, ANSI standards, and a Safe Work of
Australia information sheet on use of carbon nanotubes either
specifically recommend a hierarchy of controls or recommend an approach
using engineering controls to prevent exposures before using personal
protective equipment.
    EPA Response: EPA agrees that a hierarchy of controls should be
applied and that personal protective equipment should be the last
option to prevent exposures. EPA's NCELs language in consent orders
states that preventing exposures is the preferred method for protecting
workers. See: http://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf. Most PMN and SNUN submissions describe engineering
controls and other steps that will be taken to reduce worker exposures.
However, in many cases these measures may not sufficiently reduce
exposures or it may not be feasible for every manufacturer or processor
to use engineering controls. EPA requires personal protective equipment
only for workers who are reasonably likely to be exposed in order to
prevent unreasonable risks. It should be noted that OSHA regulations
only recommend but do not require specific engineering controls for
existing chemical substances even when there are available methods for
detecting those chemical substances and there are engineering controls
known to prevent exposures. For new chemical substances, there is often
no data on detection methods and limited data on which engineering
controls prevent worker exposures in all situations. In addition,
because new chemical substances have not previously been in commerce,
there are no specific applicable exposure limits or protective
equipment requirements under any other statute. In the case of
nanomaterials, such as carbon nanotubes, there is currently even more
uncertainty associated with detection methods and effectiveness of
certain engineering controls.
    EPA has added language to the SNURs in this final action to require
engineering controls and administrative controls where feasible but
will not change its approach at this time for new chemical substances
regarding requests for alternative control measures as set out in 40
CFR 721.30, NCELs requirements, or its requirements for personal
protective equipment. Persons who are subject to a SNUR must follow any
personal protective equipment requirements where workers are reasonably
likely to be exposed. Persons subject to SNUR requirements must request
and demonstrate, as set out in 40 CFR 721.30, how any alternative
control methods they propose are equivalent to existing SNUR
requirements.
    Comment 15: EPA also received one comment supporting the SNURs and
another comment discussing efforts of the tire industry to incorporate
nanomaterials into their products.
    EPA response: Neither comment contained a substantive comment
regarding the rule so EPA has no response.

VI. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered
ongoing rather than new, any person could defeat the SNUR by initiating
the significant new use before the final rule was issued. Therefore EPA
has designated the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing. Consult the
Federal Register notice of April 24, 1990 (55 FR 17376) (FRL-3658-5)
for a more detailed discussion of the cutoff date for ongoing uses.
    Any person, who began commercial manufacture, or processing of the
chemical substances 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 the final rule. Persons
who ceased those activities will have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires, before engaging in
any activities designated as significant new uses. If a person were to
meet the conditions of advance compliance under 40 CFR 721.45(h), the
person would be considered to have met the requirements of the final
SNUR for those activities.

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. The two exceptions
are:
    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 Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
    In the TSCA section 5(e) consent orders for 15 of the chemical
substances regulated under this rule, EPA has established restrictions
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 restrictions will not be
removed until EPA determines that the unrestricted use will not present
an unreasonable risk of injury or result in significant or substantial
exposure or environmental release. This determination is usually made
based on the results of the required or recommended toxicity tests.
    In cases where EPA issued a TSCA section 5(e) consent order that
requires or recommends certain testing, Unit IV. of the proposed rule
lists tests required or recommended in each of the section 5(e) consent
orders underlying the proposed 5(e) SNURs, and lists tests recommended
for the substances subject to the proposed non-5(e) SNURs. 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.
    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

    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
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
Sec. Sec.  721.25 and 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, and processors of the
chemical substances during the development of the direct final rule.
EPA's complete Economic Analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2010-0279.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for several new chemical
substances that were the subject of PMNs and, in some cases, a TSCA
section 5(e) consent order. 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

    On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that
promulgation of a SNUR does not have a significant economic impact on a
substantial number of small entities where the following are true:
    1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.

    2. The SNUN submitted by any small entity would not cost
significantly more than $8300.
    A copy of that certification is available in the docket for this
rule.
    This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.

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
effect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action will 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 final rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule does not significantly nor 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

    Since this action does not involve any technical standards, NTTAA
section 12(d) (15 U.S.C. 272 note), does not apply to this action.
    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).

XI. 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 final 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: June 14, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, 40 CFR parts 9 and 721 are 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
------------------------------------------------------------------------

                                * * * * *
721.10265................................  2070-0012
721.10266................................  2070-0012
721.10267................................  2070-0012
721.10268................................  2070-0012
721.10269................................  2070-0012
721.10270................................  2070-0012
721.10271................................  2070-0012
721.10272................................  2070-0012
721.10273................................  2070-0012
721.10274................................  2070-0012
721.10275................................  2070-0012
721.10276................................  2070-0012
721.10277................................  2070-0012
721.10278................................  2070-0012
721.10279................................  2070-0012
721.10280................................  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
2. Add Sec.  721.10265 to subpart E to read as follows:

Sec.  721.10265  Ethane, 2-bromo-1, 1-difluoro-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethane, 2-bromo-
1,1-difluoro-. (PMN P-04-244; CAS No. 359-07-9) 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 PMN substance after it has been completely reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), (b)
(concentration set at 0.1 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirator with an assigned
protection factor (APF) of at least 1000 meets the minimum requirements
for Sec.  721.63(a)(4): NIOSH-certified supplied-air respirator
operated in pressure demand or other positive pressure mode and
equipped with a tight-fitting full facepiece.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, or processor may choose to follow
the new chemical exposure limit (NCEL) provisions listed in the TSCA
section 5(e) consent order for this substance. The NCEL is 0.5 mg/m\3\
as an 8-hour time-weighted average. Persons who wish to pursue NCELs as
an alternative to the Sec.  721.63 respirator requirements may request
to do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv)(use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k)(chemical intermediate for a herbicide)
and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable
to manufacturers, 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 paragraph (a)(2)(ii) of
this section.
0
3. Add Sec.  721.10266 to subpart E to read as follows:

Sec.  721.10266   Multi-walled carbon nanotubes (generic) (P-08-733 and
P-08-734).

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as multi-
walled carbon nanotubes (PMNs P-08-733 and P-08-734) are 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 PMN substances after they have been
completely reacted (cured); embedded or incorporated into a polymer
matrix that has been reacted (cured); embedded, encapsulated or
incorporated by the polymer binder into a permanent solid matrix (does
not include slurries) 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)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., physical containment, exhaust
control ventilation, or isolation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. The following National
Institute for Occupational Safety and Health (NIOSH)--certified
respirator with an assigned protection factor (APF) of at least 50
meets the minimum requirements for Sec.  721.63(a)(4): NIOSH-certified
air-purifying, tight-fitting full-face respirator equipped with N-100,
P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (f), (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, and processors of these substances.
    (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 paragraph (a)(2)(ii) of
this section.

0
4. Add Sec.  721.10267 to subpart E to read as follows:

Sec.  721.10267  [5,6]Fullerene-C60-Ih.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as [5,6]Fullerene-C60-
Ih (PMN P-09-54; CAS No. 99685-96-8) 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 PMN substance after it has been completely reacted (cured);
embedded or incorporated into a polymer matrix that itself has been
reacted (cured); 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)(iv), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 filter.

    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k)(an intermediate compound for use in
producing downstream products that will in turn be used in organic
electronic devices and an additive to improve mechanical properties or
conductivity; a compound used to improve the mechanical properties of
rubbers, plastics, and lubricants; or a compound for use as an additive
to increase the conductivity of materials).
    (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, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10268 to subpart E to read as follows:

Sec.  721.10268  [5,6]Fullerene-C70-D5h(6).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as [5,6]Fullerene-C70-
D5h(6) (PMN P-09-55; CAS No. 115383-22-7) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); 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)(iv), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63 (a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (an intermediate compound for use in
producing downstream products that will in turn be used in organic
electronic devices and an additive to improve mechanical properties or
conductivity; a compound used to improve the mechanical properties of
rubbers, plastics, and lubricants; or a compound for use as an additive
to increase the conductivity of materials).
    (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, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
6. Add Sec.  721.10269 to subpart E to read as follows:

Sec.  721.10269  [5,6]Fullerene-C84-D2.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as [5,6]Fullerene-C84-
D2 (PMN P-09-56; CAS No. 145809-19-4) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); 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)(iv), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k)(an intermediate compound for use in
producing downstream products that will in turn be used in organic
electronic devices and an additive to improve mechanical properties or
conductivity; a compound used to improve the mechanical properties of
rubbers, plastics, and lubricants; or a compound for use as an additive
to increase the conductivity of materials).
    (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, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.10270 to subpart E to read as follows:

Sec.  721.10270  [5,6]Fullerene-C84-D2d.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as [5,6]Fullerene-C84-
D2d (PMN P-09-57; CAS No. 145809-20-7) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); 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)(iv), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),

engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (an intermediate compound for use in
producing downstream products that will in turn be used in organic
electronic devices and an additive to improve mechanical properties or
conductivity; a compound used to improve the mechanical properties of
rubbers, plastics, and lubricants; or a compound for use as an additive
to increase the conductivity of materials).
    (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, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10271 to subpart E to read as follows:

Sec.  721.10271  3'H-Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic
acid, 3'-phenyl-, methyl ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3'H-
Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-,
methyl ester, (PMNs P-09-142 and Chemical A in P-09-416, CAS Number
160848-22-6) 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 PMN
substances after they have been completely reacted (cured); embedded or
incorporated 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)(clothing which covers any other exposed
areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k) (use as a compound used in fabrication
and/or operation of electronic devices that enables or improves the
conductivity, efficiency, voltage or other characteristics of the
device, a compound that improves the mechanical properties of
lubricants and plastics, or use as an acceptor molecule in a polymer
coating in an encapsulated organic photovoltaic electronic device) 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, 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 paragraph (a)(2)(ii) of
this section.

0
9. Add Sec.  721.10272 to subpart E to read as follows:

Sec.  721.10272  3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-
butanoic acid, 3'-phenyl-,methyl ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as 3'H-
Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-,
methyl ester (PMNs P-09-143 and Chemical B in P-09-416, CAS Number
609771-63-3) 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 PMN
substances after they have been completely reacted (cured); embedded or
incorporated 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) (clothing which covers any other
exposed areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (use as a compound used in fabrication
and/or operation of electronic devices that enables or improves the
conductivity, efficiency, voltage or other characteristics of the
device, a compound that improves the mechanical properties of
lubricants and plastics, or use as an acceptor molecule in a polymer
coating in an encapsulated organic photovoltaic electronic device) 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, 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 paragraph (a)(2)(ii) of
this section.

0
10. Add Sec.  721.10273 to subpart E to read as follows:

Sec.  721.10273  3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-
butanoic acid, 3'-phenyl-, methyl ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as 3'H-
Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-
,methyl ester (P-09-144 and Chemical C in P-09-416, CAS Number 1051371-
21-1) 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 PMN
substances after they have been completely reacted (cured); embedded or
incorporated 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) (clothing which covers any other
exposed areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (use as a compound used in fabrication
and/or operation of electronic devices that enables or improves the
conductivity, efficiency, voltage or other characteristics of the
device, a compound that improves the mechanical properties of
lubricants and plastics, or use as an acceptor molecule in a polymer
coating in an encapsulated organic photovoltaic electronic device) 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, 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 paragraph (a)(2)(ii) of
this section.

0
11. Add Sec.  721.10274 to subpart E to read as follows:

Sec.  721.10274  Multi-walled carbon nanotubes (generic) (P-09-188).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-09-188) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); or embedded in a permanent solid polymer form
with a concentration of the PMN substance equal to or below 30 percent
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), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (a)(4), engineering control
measures (e.g., physical containment, exhaust control ventilation, or
isolation) or administrative control measures (e.g., workplace policies
and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirator meets the
minimum requirements for Sec.  721.63(a)(4): NIOSH-certified air-
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k), (m), (o), 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, 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 paragraph (a)(2)(ii) of
this section.

0
12. Add Sec.  721.10275 to subpart E to read as follows:

Sec.  721.10275  Multi-walled carbon nanotubes (generic) (P-09-0417).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-09-417) 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 PMN substance it has been completely reacted (cured);
embedded or incorporated into a polymer matrix that itself has been
reacted (cured); 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)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., physical containment, exhaust
control ventilation, or isolation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. The following National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at

least 50 meets the minimum requirements for Sec.  721.63(a)(4): NIOSH-
certified air-purifying, tight-fitting full-face respirator equipped
with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k) (plastics additive to improve
electrical, thermal and/or mechanical properties), (m), and (o).
    (iii) Release to Water. Requirements as specified in Sec.
721.90(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, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.10276 to subpart E to read as follows:

Sec.  721.10276  Multi-walled carbon nanotubes (generic) (P-10-39).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-10-39) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); embedded in a permanent solid polymer, metal,
glass, or ceramic 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), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (a)(4), engineering control
measures (e.g., physical containment, exhaust control ventilation, or
isolation) or administrative control measures (e.g., workplace policies
and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
approved protection factor (APF) of at least 50 meets the minimum
requirements for Sec.  721.63(a)(4): NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped with N-100, P-100, or R-100
filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k), (m), (o), and (p)(120,000 kilograms
of the aggregate of P-10-39 and P-10-40 the substance described in
Sec.  721.10277).
    (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, and processors of these substances.
    (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 paragraph (a)(2)(ii) of
this section.

0
14. Add Sec.  721.10277 to subpart E to read as follows:

Sec.  721.10277  Single-walled and multi-walled carbon nanotubes
(generic) (P-10-40).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as single-
walled and multi-walled carbon nanotubes (PMN P-10-40) 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 PMN substance after it has been completely
reacted (cured); embedded or incorporated into a polymer matrix that
itself has been reacted (cured); embedded in a permanent solid polymer,
metal, glass, or ceramic 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), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (a)(4), engineering control
measures (e.g., physical containment, exhaust control ventilation, or
isolation) or administrative control measures (e.g., workplace policies
and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at least 50 meet the minimum
requirements for Sec.  721.63(a)(4): NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped with N-100, P-100, or R-100
filter.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k), (m), (o), and (p)(120,000 kilograms of
the aggregate of P-10-40 and P-10-39 the substance described in Sec.
721.10276).
    (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, and processors of these substances.
    (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 paragraph (a)(2)(ii) of
this section.

0
15. Add Sec.  721.10278 to subpart E to read as follows:

Sec.  721.10278  4,4'-Bipyridinium, 1-(phosphonoalkyl)-1'-substituted-,
salt with anion (1:2) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 4,4'-
Bipyridinium, 1-(phosphonoalkyl)-1'-substituted-, salt with anion (1:2)
(PMN P-10-224) 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)(3)(applicable to gloves only), (a)(4),
(a)(6), (b)(concentration set at 1.0 percent), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at

least 10 meet the minimum requirements for Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with
a loose- fitting hood or helmet and high efficiency particulate air
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet, or
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (f), (j), (s)(1000 kilograms), (v)(1), and
(v)(2).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, 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 paragraph (a)(2)(ii) of
this section.
    The provisions of Sec.  721.1725(b)(1) apply to this section.

0
16. Add Sec.  721.10279 to subpart E to read as follows:

Sec.  721.10279  Multi-walled carbon nanotubes (generic) (P-10-246).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-10-246) 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 PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that itself has
been reacted (cured); 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)(6)(i),
(a)(6)(ii), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., physical containment, exhaust
control ventilation, or isolation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. The following National
Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 50
meet the minimum requirements for Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (B) NIOSH-certified powered air-purifying respirator equipped with
a loose-fitting hood or helmet and high efficiency particulate air
(HEPA) filters; or
    (C) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k) (conductivity additive to resins,
rubber, and to battery electrodes), and (q).
    (iii) Release to water. Requirements as specified in Sec.
721.90(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, 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 paragraph (a)(2)(ii) of
this section.

0
17. Add Sec.  721.10280 to subpart E to read as follows:

Sec.  721.10280  Benzene ethenyl-, polymer with 1,3-butadiene,
brominated.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene ethenyl-,
polymer with 1,3-butadiene, brominated (PMN P-10-476; CAS No. 1195978-
93-8)) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) (manufacture by the method where the
average number molecular weight is in the range of 1000 to 10,000
daltons, or where less than 5 percent of the particles are in the
respirable range of 10 microns or less and the average number molecular
weight is greater than or equal to 10,000 daltons).
    (ii) [Reserved]
    (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), and (i) are applicable to manufacturers, and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2013-15032 Filed 6-25-13; 8:45 am]
BILLING CODE 6560-50-P