Proposed Significant New Use Rule for Multi-walled Carbon Nanotubes, 5546-5551 [2010-2256]
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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Proposed Rules
wastes involved in the manufacture,
use, and disposal of explosives.
2. Even with respect to activities
regulated by OSHA, the proposed rule
had a limited scope. It would not have
covered the sale or use of consumer and
public display fireworks (72 FR 18799).
OSHA’s construction standards at 29
CFR 1926 subpart U cover the hazards
associated with blasting in the
construction and demolition industries.
The general industry uses addressed by
the proposal include blasting of rocks,
slag pockets, and beaver dams, as well
as blasting associated with metal
hardening, stump removal, pond
creation, and avalanche control, and
various types of blasting used to create
art sculptures. Compared to the use of
explosives by the construction and
demolition industries, these general
industry uses do not require large
amounts of explosives, and employers
perform them relatively infrequently.
Moreover, employers engaged in the
manufacture of explosives (other than
blasting agents) and pyrotechnics must
already meet the requirements
contained in OSHA’s Process Safety
Management (PSM) Standard at 29 CFR
1910.119, which covers working
conditions during the manufacture of
highly hazardous chemicals (29 CFR
1910.109(k)). The PSM Standard
addresses many of the hazards
associated with the manufacture of
explosives and pyrotechnics.
3. Finally, OSHA did not propose
substantive changes to many of the
requirements in the existing standard.
Whether or not the rulemaking
continues, the existing protective
provisions addressing hazards
associated with storing explosives;
transporting explosives; using
explosives and blasting agents; packing,
marking, and storing explosives at piers,
railway stations, and cars or vessels;
mixing, storing, and transporting
blasting agents; mixing water gel
explosives; storing ammonium nitrate;
and storing small arms ammunition,
small arms primers, and small arms
propellants, will remain in effect.
The limited scope of the rulemaking
and the breadth of existing Federal
protections necessarily constrained the
relative safety benefits of the
rulemaking, especially when compared
with OSHA’s higher priority rulemaking
activities. The Preliminary Economic
and Regulatory Screening Analysis
conducted by OSHA in conjunction
with the proposed rule supports this
conclusion (72 FR 18828). In this
analysis, OSHA examined the extent to
which the proposed rulemaking would
reduce the number of deaths and
injuries attributable to explosive
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accidents in general industry by
reviewing its accident-investigation
reports for the years 1992–2002. OSHA
concluded that compliance with the
new requirements of the amended
standard might have prevented only one
of the 39 documented explosives
accidents. Therefore, the proposed
standard would have had limited
benefit for workers exposed to explosive
hazards.
B. Using Limited Resources Efficiently
In light of these limited benefits,
OSHA cannot justify allocating the
substantial resources it would need to
utilize in order to issue a new proposal,
analyze comments submitted by the
regulated community, conduct a
hearing, and promulgate an amended
standard. As noted above, the existing
standard already addresses many of the
hazards associated with explosives, and
much of the proposal involved
clarifying the terms and scope of that
standard. The proposal would have: (1)
Increased the clarity and focus of the
standard by rewriting requirements in
plain language, correcting internal
inconsistencies and duplicative
requirements, and removing references
to public safety that are beyond OSHA’s
regulatory authority; (2) increased
harmonization with other Federal
standards that regulate explosives; 1 and
(3) addressed the scope of preemption
by other Federal agencies (notably DOT
and ATF) of OSHA authority over
working conditions in the explosives
industry. While these revisions could
have reduced confusion among the
regulated community regarding
compliance and enforcement authority,
they would have no substantive effect
on the safety measures employers must
take to control explosives hazards.
By withdrawing this proposal, OSHA
can devote the resources that would
have been utilized in completing the
rulemaking to deservedly higherpriority projects. For example, OSHA
recently announced a rulemaking to
reduce combustible dust hazards in
general industry. Combustible dust
explosions have resulted in more than
130 deaths and 780 injuries since 1980.
OSHA is also preparing to propose a
standard governing occupational
1 For instance, by adopting the ATF system to
classify explosives storage magazines, or by
following the example of DOT, which adopted the
United Nations Globally Harmonized System of
Classification and Labeling of Chemicals to classify
explosives. This rulemaking goal is actively being
addressed, as OSHA recently issued a proposal to
conform its Hazard Communication Standard, 29
CFR 1910.1200, to the GHS. (74 FR 50280.) This
proposal generally adopts the GHS’s requirements
for classifying, labeling, and providing safety data
sheets for explosives.
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exposure to respirable silica. Inhalation
of this substance, which is extremely
widespread, causes lung disease,
silicosis and lung cancer. Terminating
the explosives rulemaking will free
resources for these and other highimpact proceedings.
C. Conclusion
Based on the findings discussed in the
preceding section, OSHA concludes that
terminating the proposed rulemaking
will not diminish worker protection
because § 1910.109, along with other
OSHA standards and the standards of
other Federal agencies, provide workers
with substantial protection from
explosive hazards. In addition,
alternatives exist to increase the
protection afforded by, and to improve
the clarity of the standard. Therefore,
terminating the proposed rulemaking
will enable OSHA to devote its limited
resources to other rulemakings that will
provide greater protection to workers
from occupational hazards than would
the proposed rulemaking.
III. Authority and Signature
David Michaels, PhD MPH, Assistant
Secretary of Labor for Occupational
Safety and Health, U.S. Department of
Labor, 200 Constitution Avenue, NW.,
Washington, DC, 20210, directed the
preparation of this notice. It is issued
pursuant to Sections 4, 6, and 8 of the
Occupational and Safety and Health Act
of 1970 (29 U.S.C. 653, 655, 657),
Secretary’s Order 5–2007 (72 FR 31160),
and 29 CFR part 1911.
Signed at Washington, DC, on January 29,
2010.
David Michaels,
Assistant Secretary of Labor for Occupational
Safety and Health.
[FR Doc. 2010–2273 Filed 2–2–10; 8:45 am]
BILLING CODE 4510–26–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2009–0686; FRL–8796–7]
RIN 2070–AB27
Proposed Significant New Use Rule for
Multi-walled Carbon Nanotubes
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the chemical substance
identified generically as multi-walled
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carbon nanotubes (P–08–199). This
action would require persons who
intend to manufacture, import, or
process the substance for an activity that
is designated as a significant new use by
this proposed rule to notify EPA at least
90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
that activity before it occurs.
DATES: Comments must be received on
or before March 5, 2010.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2009–0686, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2009–0686.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2009–0686. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
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that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Jim
Alwood, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8974; e-mail address:
alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you manufacture, import,
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process, or use the chemical substance
contained in this proposed rule.
Potentially affected entities may
include, but are not limited to:
• Manufacturers, importers, or
processors of the subject chemical
substance (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
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127 and 19 CFR
127.28 (the corresponding EPA policy
appears at 40 CFR part 707, subpart B).
Chemical importers must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA. Importers of
chemicals subject to a final SNUR must
certify their compliance with the SNUR
requirements. In addition, any persons
who export or intend to export a
chemical substance that is the subject of
this proposed rule on or after March 5,
2010 are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM
as CBI and then identify electronically
within the disk or CD-ROM the specific
information that is claimed as CBI. In
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addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
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EPA is proposing this SNUR using
notice and comment procedures. This
SNUR will require persons to notify
EPA at least 90 days before commencing
the manufacture, import, or processing
of the specific multi-walled carbon
nanotubes identified by the notice for
any activity designated by this SNUR as
a significant new use. Receipt of such
notices allows EPA to assess risks that
may be presented by the intended uses
and, if appropriate, to regulate the
proposed use before it occurs.
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
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new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture,
import, or process the chemical
substance for that use. The mechanism
for reporting under this requirement is
established under § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
final rule. Provisions relating to user
fees appear at 40 CFR part 700.
According to § 721.1(c), persons subject
to this SNUR must comply with the
same notice requirements and EPA
regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include
the information submission
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 1612)
import certification requirements
promulgated at 19 CFR 12.118 through
12.127, and 19 CFR 127.28 (the
corresponding EPA policy appears at 40
CFR part 707, subpart B). Chemical
importers must certify that the shipment
of the chemical substance complies with
all applicable rules and orders under
TSCA. Importers of chemical substances
subject to a final SNUR must certify
their compliance with the SNUR
requirements. In addition, any persons
who export or intend to export a
chemical substance identified in a final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2612 (b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
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• 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
substance that is the subject of this
proposed SNUR, EPA considered
relevant information about the toxicity
of the chemical substance, likely human
exposures and environmental releases
associated with possible uses, and the
four bulleted factors listed in TSCA
section 5(a)(2) in this Unit.
For the multi-walled carbon
nanotubes described in P–08–199, EPA
believes that certain changes from the
use scenario described in the PMN
could result in increased exposures,
thereby constituting a ‘‘significant new
use.’’ EPA has determined that activities
proposed as a ‘‘significant new use’’
satisfy the two requirements stipulated
in § 721.170(c)(2), i.e., 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.
IV. Substance Subject to this Proposed
Rule
EPA is proposing to establish
significant new use and recordkeeping
requirements for a chemical substance
in 40 CFR part 721, subpart E. This
SNUR applies only to the multi-walled
carbon nanotubes described in P–08–
199. In the past, some stakeholders have
asked whether these types of SNURs
apply to all variants of carbon
nanotubes. This is not the case.
PMN Number P–08–199
Chemical name: Multi-walled carbon
nanotubes (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as an additive/
filler for polymer composites and
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support media for industrial catalysts.
Based on test data on analogous
respirable, poorly soluble particulates
and on other carbon nanotubes (CNTs),
EPA identified concerns for lung effects,
immunotoxicity, and mutagenicity from
exposure to the PMN substance. For the
uses described in the PMN, worker
inhalation and dermal exposures are
minimal due to the use of adequate
personal protective equipment.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that use of the
substance without the use of gloves and
protective clothing, where there is a
potential for dermal exposure; use of the
substance without a National Institute
for Occupational Safety and Health
(NIOSH)-approved full-face respirator
with an N100 cartridge, where there is
a potential for inhalation exposure; or
use other than as described in the PMN,
may cause serious health effects. Based
on this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of the
following tests would help characterize
the human health effects of the PMN
substance: A bacterial reverse mutation
test (OPPTS Harmonized Test Guideline
870.5100) in vitro; a mammalian
erythrocyte micronucleus test (OPPTS
Harmonized Test Guideline 870.5395 or
Organisation for Economic Co-operation
and Development (OECD) 474 test
guideline) in vivo, in bone marrow, by
the intraperitoneal route; an
immunotoxicity test (OPPTS
Harmonized Test Guideline 870.7800);
and a 90–day inhalation toxicity test
(OPPTS Harmonized Test Guideline
870.3465), including a post-exposure
observation period of up to 3 months.
Evaluation should include markers of
damage, oxidant stress, cell
proliferation, the degree/intensity and
duration of pulmonary inflammation,
and cytotoxic effects and histopathology
of pulmonary issues, in addition to the
standard requirements in the OPPTS
Harmonized Test Guideline 870.3465.
CFR citation: 40 CFR 721.10183.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the chemical
substance P–08–199, EPA determined
that one or more of the criteria of
concern established at § 721.170 were
met, as discussed in Unit IV.
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B. Objectives
EPA is proposing this SNUR for a
chemical substance that has undergone
premanufacture review because the
Agency wants to achieve the following
objectives with regard to the significant
new uses designated in this proposed
rule:
• EPA would receive notice of any
person’s intent to manufacture, import,
or process a listed chemical substance
for the described significant new use
before that activity begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing a listed chemical substance
for the described significant new use.
• EPA would be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
substance before the described
significant new use of that chemical
substance occurs, provided that
regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
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 https://www.epa.gov/opptintr/
newchems/pubs/invntory.htm.
VI. Notice and Comment Procedures
EPA is issuing this SNUR by notice
and comment procedure, as described in
§ 721.170(d)(4). In accordance with
§ 721.170(d)(4)(ii)(A), persons are being
given the opportunity to submit
comments on or before March 5, 2010
on whether EPA should establish
notification requirements.
VII. Applicability of the Proposed Rule
to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. EPA solicits comments on
whether any of the uses proposed as
significant new uses are ongoing.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule were considered ongoing rather
than new, it would be difficult for EPA
to establish SNUR notice requirements
because a person could defeat the SNUR
by initiating the significant new use
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before the rule became final, and then
argue that the use was ongoing before
the effective date of the final rule. Thus,
persons who begin commercial
manufacture, import, or processing
activities with the chemical substances
that would be regulated as a ‘‘significant
new use’’ through this proposed rule,
must cease any such activity before the
effective date of the rule if and when
finalized. To resume their activities,
these persons would have to comply
with all applicable SNUR notice
requirements and wait until the notice
review period, including all extensions,
expires.
EPA has promulgated provisions to
allow persons to comply with this
proposed SNUR before the effective
date. If a person were to meet the
conditions of advance compliance
under § 721.45(h), the person would be
considered exempt from the
requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN, except where the chemical
substance subject to the SNUR is also
subject to a test rule under TSCA
section 4 (see TSCA section 5(b)).
Persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
EPA recommended certain testing in
Unit IV. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the OPPTS
harmonized test guidelines referenced
in this document electronically, please
go to https://www.epa.gov/oppts and
select ‘‘Test Methods and Guidelines.’’
The Organisation for Economic Cooperation and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
The recommended tests may not be
the only means of addressing the
potential risks of the chemical
substance. However, SNUNs submitted
for significant new uses without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior PMN or SNUN submitter. EPA
recommends that potential SNUN
submitters contact EPA early enough so
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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Proposed Rules
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substance.
• Potential benefits of the chemical
substance.
• Information on risks posed by the
chemical substance compared to risks
posed by potential substitutes.
IX. SNUN Submissions
As stated in Unit II.C., according to
§ 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 § 720.50. SNUNs must be
mailed to the Environmental Protection
Agency, OPPT Document Control Office
(7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
Information must be submitted in the
form and manner set forth in EPA Form
No. 7710–25. This form is available
from the Environmental Assistance
Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460–0001
(see § § 721.25 and 720.40). Forms and
information are also available
electronically at https://www.epa.gov/
opptintr/newchems/pubs/
pmnforms.htm.
X. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substance
subject to this proposed rule. EPA’s
complete economic analysis is available
in the public docket.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
XI. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish a
SNUR for a chemical substance that was
the subject of a PMN. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under the
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14:18 Feb 02, 2010
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PRA, unless it has been approved by
OMB and displays a currently valid
OMB control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA would amend the table
in 40 CFR part 9 to list the OMB
approval number for the information
collection requirements contained in
this proposed rule. This listing of the
OMB control numbers and their
subsequent codification in the CFR
satisfies the display requirements of
PRA and OMB’s implementing
regulations at 5 CFR part 1320. This
Information Collection Request (ICR)
was previously subject to public notice
and comment prior to OMB approval,
and given the technical nature of the
table, EPA finds that further notice and
comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), to amend this table without
further notice and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action would not impose any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
in this unit. The requirement to submit
a SNUN applies to any person
(including small or large entities) who
intends to engage in any activity
described in the rule as a ‘‘significant
new use.’’ Because these uses are ‘‘new,’’
based on all information currently
available to EPA, it appears that no
small or large entities presently engage
in such activities. A SNUR requires that
any person who intends to engage in
such activity in the future must first
notify EPA by submitting a SNUN.
Although some small entities may
decide to pursue a significant new use
in the future, EPA cannot presently
determine how many, if any, there may
be. However, EPA’s experience to date
is that, in response to the promulgation
of over 1,000 SNURs, the Agency
receives on average only 5 notices per
year. Of those SNUNs submitted from
2006–2008, only one appears to be from
a small entity. In addition, the estimated
reporting cost for submission of a SNUN
(see Unit IX.) is minimal regardless of
the size of the firm. Therefore, the
potential economic impacts of
complying with this SNUR are not
expected to be significant or adversely
impact a substantial number of small
entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR
29684) (FRL–5597–1), the Agency
presented its general determination that
final SNURs are not expected to have a
significant economic impact on a
substantial number of small entities,
which was provided to the Chief
Counsel for Advocacy of the Small
Business Administration.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
would not have a significant adverse
economic impact on a substantial
number of small entities. The rationale
supporting this conclusion is discussed
E. Executive Order 13132
This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
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Fmt 4702
Sfmt 4702
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 reason to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any affect on small
governments subject to the requirements
of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
E:\FR\FM\03FEP1.SGM
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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Proposed Rules
Dated: January 27, 2010.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention
and Toxics.
Federalism (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would not significantly or uniquely
affect the communities of Indian Tribal
governments, nor would it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
Therefore, it is proposed that 40 CFR
part 721 be amended as follows:
Jkt 220001
Office of the Secretary
49 CFR Part 23
[Docket No. OST–2010–0022]
1. The authority citation for part 721
would continue to read as follows:
Participation by Disadvantaged
Business Enterprises in Airport
Concessions
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
DOT.
2. Add § 721.10183 to subpart E to
read as follows:
§ 721.10183 Multi-walled carbon
nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as multi-walled carbon
nanotubes (PMN P–08–199) 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 § 721.63
(a)(1), (a)(2)(i), (a)(2)(ii), (a)(4), (a)(5)
(National Institute for Occupational
Safety and Health (NIOSH)-approved
full-face respirators with N100
cartridges), (a)(6)(i), and (c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (additive/filler
for polymer composites and support
media for industrial catalysts).
(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 § 721.125
(a), (b), (c), (d), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2010–2256 Filed 2–2–10; 8:45 am]
BILLING CODE 6560–50–S
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
14:18 Feb 02, 2010
DEPARTMENT OF TRANSPORTATION
RIN 2105–AD88
PART 721—[AMENDED]
List of Subjects in 40 CFR Part 721
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5551
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AGENCY:
ACTION:
Office of the Secretary (OST),
Notice of proposed rulemaking.
SUMMARY: The Department of
Transportation is proposing to remove
the ‘‘sunset’’ provision from its rule
governing the airport concessions
disadvantaged business enterprise
program. The rule would instead
provide for periodic program reviews. In
addition, in the interest of initiating a
program review, the Department is
soliciting comments on any changes that
should be made in the rule. These
comments would assist the Department
in reviewing the rule and, if warranted,
proposing modifications to it in the
future.
DATES: Comments on the proposal to
remove the sunset provision must be
received by March 5, 2010. Responses to
the request for comments on potential
modifications to the rule must be
received by November 1, 2010. Latefiled comments will be considered to
the extent practicable.
ADDRESSES: You may submit comments
(identified by the agency name and DOT
Docket ID Number OST–2010–0022) by
any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and follow
the online instructions for submitting
comments.
• Mail: Docket Management Facility:
U.S. Department of Transportation, 1200
New Jersey Avenue, SE., West Building
Ground Floor, Room W12–140,
Washington, DC 20590–0001.
• Hand Delivery or Courier: West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE., between
9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays.
• Fax: 202–493–2251.
Instructions: You must include the
agency name (Office of the Secretary,
DOT) and Docket number (OST–2010–
0022) for this notice at the beginning of
your comments. You should submit two
copies of your comments if you submit
them by mail or courier. Note that all
comments received will be posted
without change to https://
www.regulations.gov including any
E:\FR\FM\03FEP1.SGM
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Agencies
[Federal Register Volume 75, Number 22 (Wednesday, February 3, 2010)]
[Proposed Rules]
[Pages 5546-5551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2256]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2009-0686; FRL-8796-7]
RIN 2070-AB27
Proposed Significant New Use Rule for Multi-walled Carbon
Nanotubes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance identified generically as multi-walled
[[Page 5547]]
carbon nanotubes (P-08-199). This action would require persons who
intend to manufacture, import, or process the substance for an activity
that is designated as a significant new use by this proposed rule to
notify EPA at least 90 days before commencing that activity. The
required notification would provide EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit that
activity before it occurs.
DATES: Comments must be received on or before March 5, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0686, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2009-0686. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0686. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
For technical information contact: Jim Alwood, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail
address: alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substance contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part
707, subpart B). Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to a final SNUR must certify
their compliance with the SNUR requirements. In addition, any persons
who export or intend to export a chemical substance that is the subject
of this proposed rule on or after March 5, 2010 are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In
[[Page 5548]]
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is proposing this SNUR using notice and comment procedures.
This SNUR will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of the specific
multi-walled carbon nanotubes identified by the notice for any activity
designated by this SNUR as a significant new use. Receipt of such
notices allows EPA to assess risks that may be presented by the
intended uses and, if appropriate, to regulate the proposed use before
it occurs.
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use. The mechanism
for reporting under this requirement is established under Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to this SNUR must comply
with the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
Chemical importers are subject to the TSCA section 13 (15 U.S.C.
1612) import certification requirements promulgated at 19 CFR 12.118
through 12.127, and 19 CFR 127.28 (the corresponding EPA policy appears
at 40 CFR part 707, subpart B). Chemical importers must certify that
the shipment of the chemical substance complies with all applicable
rules and orders under TSCA. Importers of chemical substances subject
to a final SNUR must certify their compliance with the SNUR
requirements. In addition, any persons who export or intend to export a
chemical substance identified in a final SNUR are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2612 (b)) (see
Sec. 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four bulleted factors listed in TSCA
section 5(a)(2) in this Unit.
For the multi-walled carbon nanotubes described in P-08-199, EPA
believes that certain changes from the use scenario described in the
PMN could result in increased exposures, thereby constituting a
``significant new use.'' EPA has determined that activities proposed as
a ``significant new use'' satisfy the two requirements stipulated in
Sec. 721.170(c)(2), i.e., 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.
IV. Substance Subject to this Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for a chemical substance in 40 CFR part 721, subpart E.
This SNUR applies only to the multi-walled carbon nanotubes described
in P-08-199. In the past, some stakeholders have asked whether these
types of SNURs apply to all variants of carbon nanotubes. This is not
the case.
PMN Number P-08-199
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an
additive/filler for polymer composites and
[[Page 5549]]
support media for industrial catalysts. Based on test data on analogous
respirable, poorly soluble particulates and on other carbon nanotubes
(CNTs), EPA identified concerns for lung effects, immunotoxicity, and
mutagenicity from exposure to the PMN substance. For the uses described
in the PMN, worker inhalation and dermal exposures are minimal due to
the use of adequate personal protective equipment. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without the use of gloves and
protective clothing, where there is a potential for dermal exposure;
use of the substance without a National Institute for Occupational
Safety and Health (NIOSH)-approved full-face respirator with an N100
cartridge, where there is a potential for inhalation exposure; or use
other than as described in the PMN, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health effects of the
PMN substance: A bacterial reverse mutation test (OPPTS Harmonized Test
Guideline 870.5100) in vitro; a mammalian erythrocyte micronucleus test
(OPPTS Harmonized Test Guideline 870.5395 or Organisation for Economic
Co-operation and Development (OECD) 474 test guideline) in vivo, in
bone marrow, by the intraperitoneal route; an immunotoxicity test
(OPPTS Harmonized Test Guideline 870.7800); and a 90-day inhalation
toxicity test (OPPTS Harmonized Test Guideline 870.3465), including a
post-exposure observation period of up to 3 months. Evaluation should
include markers of damage, oxidant stress, cell proliferation, the
degree/intensity and duration of pulmonary inflammation, and cytotoxic
effects and histopathology of pulmonary issues, in addition to the
standard requirements in the OPPTS Harmonized Test Guideline 870.3465.
CFR citation: 40 CFR 721.10183.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the chemical substance P-08-199, EPA determined
that one or more of the criteria of concern established at Sec.
721.170 were met, as discussed in Unit IV.
B. Objectives
EPA is proposing this SNUR for a chemical substance that has
undergone premanufacture review because the Agency wants to achieve the
following objectives with regard to the significant new uses designated
in this proposed rule:
EPA would receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA would be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
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 https://www.epa.gov/opptintr/newchems/pubs/invntory.htm.
VI. Notice and Comment Procedures
EPA is issuing this SNUR by notice and comment procedure, as
described in Sec. 721.170(d)(4). In accordance with Sec.
721.170(d)(4)(ii)(A), persons are being given the opportunity to submit
comments on or before March 5, 2010 on whether EPA should establish
notification requirements.
VII. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements because a
person could defeat the SNUR by initiating the significant new use
before the rule became final, and then argue that the use was ongoing
before the effective date of the final rule. Thus, persons who begin
commercial manufacture, import, or processing activities with the
chemical substances that would be regulated as a ``significant new
use'' through this proposed rule, must cease any such activity before
the effective date of the rule if and when finalized. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN, except where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)). Persons are required only
to submit test data in their possession or control and to describe any
other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. EPA recommended certain
testing in Unit IV. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to https://www.epa.gov/oppts and select ``Test Methods and Guidelines.'' The
Organisation for Economic Co-operation and Development (OECD) test
guidelines are available from the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under TSCA section 5(e), particularly if
satisfactory test results have not been obtained from a prior PMN or
SNUN submitter. EPA recommends that potential SNUN submitters contact
EPA early enough so
[[Page 5550]]
that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
IX. SNUN Submissions
As stated in Unit II.C., according to Sec. 721.1(c), persons
submitting a SNUN must comply with the same notice requirements and EPA
regulatory procedures as persons submitting a PMN, including submission
of test data on health and environmental effects as described in Sec.
720.50. SNUNs must be mailed to the Environmental Protection Agency,
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see Sec. Sec. 721.25 and
720.40). Forms and information are also available electronically at
https://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance subject to this proposed rule. EPA's complete
economic analysis is available in the public docket.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish a SNUR for a chemical substance
that was the subject of a PMN. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA would amend the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed rule. This listing
of the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320. This Information Collection Request
(ICR) was previously subject to public notice and comment prior to OMB
approval, and given the technical nature of the table, EPA finds that
further notice and comment to amend it is unnecessary. As a result, EPA
finds that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this
table without further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is discussed in this unit. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the rule as a ``significant new
use.'' Because these uses are ``new,'' based on all information
currently available to EPA, it appears that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of over 1,000 SNURs, the
Agency receives on average only 5 notices per year. Of those SNUNs
submitted from 2006-2008, only one appears to be from a small entity.
In addition, the estimated reporting cost for submission of a SNUN (see
Unit IX.) is minimal regardless of the size of the firm. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any affect on small governments subject to the requirements of
sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of
1995 (UMRA) (Public Law 104-4).
E. Executive Order 13132
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
[[Page 5551]]
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly or uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 27, 2010.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add Sec. 721.10183 to subpart E to read as follows:
Sec. 721.10183 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-199) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved full-face
respirators with N100 cartridges), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (additive/filler for polymer composites
and support media for industrial catalysts).
(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), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2010-2256 Filed 2-2-10; 8:45 am]
BILLING CODE 6560-50-S