Significant New Use Rule on Certain Chemical Substances, 45990-45995 [2017-21237]
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D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on the 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. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, this rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section.
E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
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F. Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969 (42
U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves a safety
zone that would prohibit persons and
vessels from transiting through a one
square mile regulated area during a
three day air show lasting nine hours
daily. It is categorically excluded from
further review under paragraph 34(g) of
Figure 2–1 of the Commandant
Instruction. A Record of Environmental
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Consideration supporting this
determination is available in the docket
where indicated under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6 and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T07–0577 to read as
follows:
■
§ 165.T07–0577 Safety Zone, Blue Angels
Air Show; St. Johns River, Jacksonville, FL.
(a) Regulated area. The following area
is a safety zone located on the St. Johns
River in Jacksonville, FL. All waters of
the St. Johns River encompassed within
an imaginary line connecting the
following points: Starting at Point 1 in
position 30°13′41″ N.; 081°39′45″ W.
thence due east to Point 2 in position
30°13″41″ N.; 081°38′35″ W. thence
south to Point 3 in position 30°14′27″
N.; 081°38′35″ W. thence west to Point
4 in position 30°14′27″ N.; 081°39′45″
W. thence following the shoreline north
back to the point of origin. These
coordinates are based on North
American Datum 1983.
(b) Definition. The term ‘‘designated
representative’’ means Coast Guard
Patrol Commanders, including Coast
Guard coxswains, petty officers, and
other officers operating Coast Guard
vessels, and Federal, state, and local
officers designated by or assisting the
Captain of the Port Jacksonville in the
enforcement of the regulated area.
(c) Regulations. (1) All persons and
vessels are prohibited from entering,
transiting through, anchoring in, or
remaining within the regulated area
unless authorized by the Captain of the
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Port Jacksonville or a designated
representative.
(2) Persons and vessels desiring to
enter, transit through, anchor in, or
remain within the regulated area may
contact the Captain of the Port
Jacksonville by telephone at (904) 714–
7557, or a designated representative via
VHF–FM radio on channel 16, to
request authorization. If authorization is
granted, all persons and vessels
receiving such authorization must
comply with the instructions of the
COTP Jacksonville or a designated
representative.
(3) The Coast Guard will provide
notice of the regulated area through
Broadcast Notice to Mariners via VHF–
FM channel 16 or by on-scene
designated representatives.
(d) Enforcement period. This rule will
be enforced daily from 8 a.m. until 5
p.m. from November 3, 2017 through
November 5, 2017.
Dated: September 28, 2017.
Todd C. Wiemers,
Captain, U.S. Coast Guard, Captain of the
Port Jacksonville.
[FR Doc. 2017–21196 Filed 10–2–17; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2016–0207; FRL–9966–84]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is finalizing 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 bimodal
mixture consisting of multi-walled
carbon nanotubes and other classes of
carbon nanotubes, which was the
subject of premanufacture notice (PMN)
P–11–482. This action requires persons
who intend to manufacture (defined by
statute to include import) or process the
chemical substance for a use that is
designated as a significant new use by
this final rule to notify EPA at least 90
days before commencing that activity.
The required notification initiates EPA’s
evaluation of the intended use within
the applicable review period.
Manufacture and processing for the
significant new use is unable to
commence until EPA has conducted a
SUMMARY:
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review of the notice, made an
appropriate determination on the notice,
and take such actions as are required
with that determination. 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.
This final rule is effective
November 2, 2017.
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2016–0207. 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., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
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.
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substance identified
generically as bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes (PMN P–11–482). The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include, but are
not limited to:
Manufacturers (including importers)
or processors of the subject chemical
substance (NAICS codes 325 and
324110), e.g., chemical manufacturing
and petroleum refineries.
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. 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 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 the chemical substance
that is the subject of a proposed or final
SNUR 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.
II. Background
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FOR FURTHER INFORMATION CONTACT:
A. What action is the Agency taking?
For technical information contact:
Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (202) 564–9232;
email address: moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
EPA is finalizing a SNUR for the
chemical substance identified
generically as bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes (PMN P–11–482). This final
action requires persons who intend to
manufacture or process the chemical
substance 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. In
the Federal Register of June 8, 2017 (79
FR 26644) (FRL–9959–37), EPA
proposed a SNUR for this chemical
substance that was the subject of P–11–
SUPPLEMENTARY INFORMATION:
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45991
482. EPA received no comments to the
proposed SNUR and is finalizing the
SNUR as proposed. See the proposed
SNUR for details and the basis of the
proposed SNUR.
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 the four bulleted TSCA
section 5(a)(2) factors listed in Unit III
of this document. 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 (15
U.S.C. 2604(a)(1)(B)(i)). TSCA
furthermore prohibits such
manufacturing or processing from
commencing until EPA has conducted a
review of the notice, made an
appropriate determination on the notice,
and taken such actions as are required
in association with that determination
(15 U.S.C. 2604(a)(1)(B)(ii)). As
described in Unit V., the general SNUR
provisions are found at 40 CFR part 721,
subpart A. Persons who must report are
described in § 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 these SNURs must comply with the
same SNUN 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 must either determine that the
significant new use is not likely to
present an unreasonable risk of injury or
take such regulatory action as is
associated with an alternative
determination before the manufacture or
processing for the significant new use
can commence. If EPA determines that
the significant new use is not likely to
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present an unreasonable risk, EPA is
required under TSCA section 5(g) to
make public, and submit for publication
in the Federal Register, a statement of
EPA’s findings.
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 authorizes EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance identified generically as
bimodal mixture consisting of multiwalled carbon nanotubes and other
classes of carbon nanotubes (PMN P–
11–482), 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 TSCA section 5(a)(2)
factors listed in this unit.
IV. Rationale and Objectives for the
Rule
jstallworth on DSKBBY8HB2PROD with RULES
A. Rationale
During review of the PMN P–11–482,
the chemical substance identified
generically as bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes, EPA concluded that one or
more of the criteria of concern
established at § 721.170 were met. For
additional discussion on this chemical
substance, see Unit II. of this rule.
B. Objectives
EPA is issuing this SNUR for a
specific chemical substance which has
undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this rule:
• EPA will receive notice of any
person’s intent to manufacture or
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process a TSCA Chemical Substance
Inventory (TSCA Inventory) 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 either determine
that the prospective manufacture or
processing is not likely to present an
unreasonable risk, or to take necessary
regulatory action associated with any
other determination, before the
described significant new use of the
chemical substance occurs.
• 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 https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
V. 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 designated
the date of public release/web posting 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 identified in
this rule 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
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requirements of the final SNUR for
those activities.
VI. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require developing any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception:
Development of test data is required
where the chemical substance subject to
the SNUR is also subject to a rule, order
or consent agreement under TSCA
section 4 (see TSCA section 5(b)(1)).
In the absence of a TSCA section 4
test rule covering the chemical
substance, persons are required only to
submit information in their possession
or control and to describe any other
information known to or reasonably
ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs
and SNUNs, the Agency has the
authority to require appropriate testing.
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 OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
In the TSCA section 5(e) consent
orders for the chemical substances
regulated under this rule, EPA has
established production volume limits in
view of the lack of data on the potential
health and environmental risks that may
be posed by the significant new uses or
increased exposure to the chemical
substances. These limits cannot be
exceeded unless the PMN submitter first
submits the results of toxicity tests that
would permit a reasoned evaluation of
the potential risks posed by these
chemical substances. Under recent
TSCA section 5(e) consent orders, each
PMN submitter is required to submit
each study at least 14 weeks (earlier
TSCA section 5(e) consent orders
required submissions at least 12 weeks)
before reaching the specified production
limit. Listings of the tests specified in
the TSCA section 5(e) consent orders are
included in Unit IV. The SNURs contain
the same production volume limits as
the TSCA section 5(e) consent orders.
Exceeding these production limits is
defined as a significant new use.
Persons who intend to exceed the
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production limit must notify the Agency
by submitting a SNUN at least 90 days
in advance of commencement of nonexempt commercial manufacture or
processing.
Any request by EPA for the triggered
and pended testing described in the
Consent Order was made based on
EPA’s consideration of available
screening-level data, if any, as well as
other available information on
appropriate testing for the PMN
substance. Further, any such testing
request on the part of EPA that includes
testing on vertebrates was made after
consideration of available toxicity
information, computational toxicology
and bioinformatics, and highthroughput screening methods and their
prediction models.
The recommended tests specified in
Unit IV. of the proposed rule may not
be the only means of addressing the
potential risks of the chemical
substance. However, submitting a SNUN
without any test data may increase the
likelihood that EPA will take action
under TSCA section 5(e), particularly if
satisfactory test results have not been
obtained from a prior PMN or SNUN
submitter. EPA recommends that
potential SNUN submitters contact EPA
early enough so that they will be able
to conduct the appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
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VII. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 721.25. E–PMN software is
available electronically at https://
www.epa.gov/reviewing-newchemicalsunder-toxic-substancescontrol-act-tsca/how-submit-e-pmn.
VIII. Economic Analysis
EPA evaluated the potential costs of
establishing SNUN requirements for
potential manufacturers and processors
of the chemical substance during the
development of the direct final rule. The
Agency’s complete Economic Analysis
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is available in the docket under docket
ID number EPA–HQ–OPPT–2016–0207.
IX. Scientific Standards, Evidence, and
Available Information
EPA has used scientific information,
technical procedures, measures,
methods, protocols, methodologies, and
models consistent with the risk
assessment documents included in the
public docket. These information
sources supply information relevant to
whether a particular use would be a
significant new use, based on relevant
factors including those listed under
TSCA section 5(a)(2).
The clarity and completeness of the
data, assumptions, methods, quality
assurance, and analyses employed in
EPA’s decision are documented, as
applicable and to the extent necessary
for purposes of this proposed significant
new use rule, in Unit II and in the
documents noted above. EPA
recognizes, based on the available
information, that there is variability and
uncertainty in whether any particular
significant new use would actually
present an unreasonable risk. For
precisely this reason, it is appropriate to
secure a future notice and review
process for these uses, at such time as
they are known more definitely. The
extent to which the various information,
procedures, measures, methods,
protocols, methodologies or models
used in EPA’s decision have been
subject to independent verification or
peer review is adequate to justify their
use, collectively, in the record for a
significant new use rule.
X. Statutory and Executive Order
Reviews
A. Executive Order 12866
This action establishes a SNUR for the
chemical substance that is the subject of
a PMN and 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 (PRA)
According to the 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
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45993
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 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 (RFA)
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (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 SNUR submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this action.
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This action 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 $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
D. Unfunded Mandates Reform Act
(UMRA)
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 UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
I. National Technology Transfer and
Advancement Act (NTTAA)
jstallworth on DSKBBY8HB2PROD with RULES
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
VerDate Sep<11>2014
15:04 Oct 02, 2017
Jkt 244001
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.
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.
2. In § 9.1, add the following section
in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
In addition, 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.
*
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This rule is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: September 15, 2017.
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]
1. The authority citation for part 9
continues to read as follows:
■
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
*
*
OMB control
No.
*
*
*
Significant New Uses of Chemical
Substances
*
*
*
*
721.10927 .............................
*
*
XI. Congressional Review Act
*
40 CFR citation
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).
*
*
*
*
*
*
*
2070–0012
*
*
*
PART 721—[AMENDED]
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add § 721.10927 to subpart E to
read as follows:
■
§ 721.10927 Bimodal mixture consisting of
multi-walled carbon nanotubes and other
classes of carbon nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes (PMN P–11–482) 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)(3),
(a)(4), (a)(6) (particulate), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
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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. A
National Institute for Occupational
Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face
respirator equipped with N–100, P–100,
or R–100 cartridges, or power air
purifying particulate respirator with an
Assigned Protection Factor (APF) of at
least 50 meets the requirements of
§ 721.63(a)(4).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). A
significant new use is any use involving
an application method that generates a
vapor, mist or aerosol.
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (a)(2), (b)(1),
(b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as
specified in § 721.90(b)(1) and (c)(1).
Any predictable or purposeful release of
a manufacturing stream associated with
any use of the substance from any site
is a significant new use other than the
water releases described in the
manufacturing process of PMN P–11–
482.
(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) through (e), (i), (j), and (k)
are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
[FR Doc. 2017–21237 Filed 10–2–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
jstallworth on DSKBBY8HB2PROD with RULES
[EPA–R04–OAR–2017–0045; FRL–9968–73–
Region 4]
Air Plan Approval; South Carolina;
Interstate Transport (Prongs 1 and 2)
for the 2010 1-Hour NO2 Standard
Environmental Protection
Agency.
ACTION: Final rule.
AGENCY:
VerDate Sep<11>2014
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Jkt 244001
The Environmental Protection
Agency (EPA) is taking final action to
approve a revision to the South Carolina
State Implementation Plan (SIP),
submitted by the South Carolina
Department of Health and
Environmental Control (DHEC), on
December 7, 2016, addressing the Clean
Air Act (CAA) interstate transport
(prongs 1 and 2) infrastructure SIP
requirements for the 2010 1-hour
Nitrogen Dioxide (NO2) National
Ambient Air Quality Standard
(NAAQS). The CAA requires that each
state adopt and submit a SIP for the
implementation, maintenance, and
enforcement of each NAAQS
promulgated by EPA, commonly
referred to as an ‘‘infrastructure SIP.’’
Specifically, EPA is taking final action
to approve South Carolina’s December
7, 2016, SIP submission addressing
prongs 1 and 2 to ensure that air
emissions in the State do not
significantly contribute to
nonattainment or interfere with
maintenance of the 2010 1-hour NO2
NAAQS in any other state.
DATES: This rule will be effective
November 2, 2017.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R04–OAR–
2017–0045. All documents in the docket
are listed on the www.regulations.gov
Web site. Although listed in the index,
some information may not be publicly
available, i.e., Confidential Business
Information or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy at
the Air Regulatory Management Section,
Air Planning and Implementation
Branch, Air, Pesticides and Toxics
Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960. EPA
requests that if at all possible, you
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday 8:30 a.m. to
4:30 p.m., excluding Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Andres Febres of the Air Regulatory
Management Section, Air Planning and
Implementation Branch, Air, Pesticides
and Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
SUMMARY:
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
45995
Atlanta, Georgia 30303–8960. Mr.
Febres can be reached by telephone at
(404) 562–8966 or via electronic mail at
febres-martinez.andres@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
By statute, SIPs meeting the
requirements of sections 110(a)(1) and
(2) of the CAA are to be submitted by
states within three years after
promulgation of a new or revised
NAAQS to provide for the
implementation, maintenance, and
enforcement of the new or revised
NAAQS. EPA has historically referred to
these SIP submissions made for the
purpose of satisfying the requirements
of sections 110(a)(1) and 110(a)(2) as
‘‘infrastructure SIP’’ submissions.
Sections 110(a)(1) and (2) require states
to address basic SIP elements such as
requirements for monitoring, basic
program requirements, and legal
authority that are designed to assure
attainment and maintenance of the
newly established or revised NAAQS.
More specifically, section 110(a)(1)
provides the procedural and timing
requirements for infrastructure SIPs.
Section 110(a)(2) lists specific elements
that states must meet for the
infrastructure SIP requirements related
to a newly established or revised
NAAQS. The contents of an
infrastructure SIP submission may vary
depending upon the data and analytical
tools available to the state, as well as the
provisions already contained in the
state’s implementation plan at the time
in which the state develops and submits
the submission for a new or revised
NAAQS.
Section 110(a)(2)(D) has two
components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i)
includes four distinct components,
commonly referred to as ‘‘prongs,’’ that
must be addressed in infrastructure SIP
submissions. The first two prongs,
which are codified in section
110(a)(2)(D)(i)(I), are provisions that
prohibit any source or other type of
emissions activity in one state from
contributing significantly to
nonattainment of the NAAQS in another
state (prong 1) and from interfering with
maintenance of the NAAQS in another
state (prong 2). The third and fourth
prongs, which are codified in section
110(a)(2)(D)(i)(II), are provisions that
prohibit emissions activity in one state
from interfering with measures required
to prevent significant deterioration of air
quality in another state (prong 3) and
from interfering with measures to
protect visibility in another state (prong
4). Section 110(a)(2)(D)(ii) requires SIPs
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Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Rules and Regulations]
[Pages 45990-45995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21237]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2016-0207; FRL-9966-84]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is finalizing 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 bimodal mixture consisting
of multi-walled carbon nanotubes and other classes of carbon nanotubes,
which was the subject of premanufacture notice (PMN) P-11-482. This
action requires persons who intend to manufacture (defined by statute
to include import) or process the chemical substance for a use that is
designated as a significant new use by this final rule to notify EPA at
least 90 days before commencing that activity. The required
notification initiates EPA's evaluation of the intended use within the
applicable review period. Manufacture and processing for the
significant new use is unable to commence until EPA has conducted a
[[Page 45991]]
review of the notice, made an appropriate determination on the notice,
and take such actions as are required with that determination. 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 November 2, 2017.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2016-0207. 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., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at 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 technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@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,
process, or use the chemical substance identified generically as
bimodal mixture consisting of multi-walled carbon nanotubes and other
classes of carbon nanotubes (PMN P-11-482). The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include, but are not limited to:
Manufacturers (including importers) or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
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. 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 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 the chemical
substance that is the subject of a proposed or final SNUR 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 a SNUR for the chemical substance identified
generically as bimodal mixture consisting of multi-walled carbon
nanotubes and other classes of carbon nanotubes (PMN P-11-482). This
final action requires persons who intend to manufacture or process the
chemical substance 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. In the Federal Register of June 8, 2017 (79
FR 26644) (FRL-9959-37), EPA proposed a SNUR for this chemical
substance that was the subject of P-11-482. EPA received no comments to
the proposed SNUR and is finalizing the SNUR as proposed. See the
proposed SNUR for details and the basis of the proposed SNUR.
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 the four bulleted TSCA section 5(a)(2)
factors listed in Unit III of this document. 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 (15 U.S.C.
2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or
processing from commencing until EPA has conducted a review of the
notice, made an appropriate determination on the notice, and taken such
actions as are required in association with that determination (15
U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR
provisions are found at 40 CFR part 721, subpart A. Persons who must
report are described in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to these SNURs must comply
with the same SNUN 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 must either determine that the
significant new use is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination before the manufacture or processing for the
significant new use can commence. If EPA determines that the
significant new use is not likely to
[[Page 45992]]
present an unreasonable risk, EPA is required under TSCA section 5(g)
to make public, and submit for publication in the Federal Register, a
statement of EPA's findings.
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 authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance identified generically as bimodal mixture consisting
of multi-walled carbon nanotubes and other classes of carbon nanotubes
(PMN P-11-482), 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 TSCA
section 5(a)(2) factors listed in this unit.
IV. Rationale and Objectives for the Rule
A. Rationale
During review of the PMN P-11-482, the chemical substance
identified generically as bimodal mixture consisting of multi-walled
carbon nanotubes and other classes of carbon nanotubes, EPA concluded
that one or more of the criteria of concern established at Sec.
721.170 were met. For additional discussion on this chemical substance,
see Unit II. of this rule.
B. Objectives
EPA is issuing this SNUR for a specific chemical substance which
has undergone premanufacture review because the Agency wants to achieve
the following objectives with regard to the significant new uses
designated in this rule:
EPA will receive notice of any person's intent to
manufacture or process a TSCA Chemical Substance Inventory (TSCA
Inventory) 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 either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
V. 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 designated the date of public release/web posting 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 identified in this rule 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.
VI. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. 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 OCSPP test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at
https://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for the chemical substances
regulated under this rule, EPA has established production volume limits
in view of the lack of data on the potential health and environmental
risks that may be posed by the significant new uses or increased
exposure to the chemical substances. These limits cannot be exceeded
unless the PMN submitter first submits the results of toxicity tests
that would permit a reasoned evaluation of the potential risks posed by
these chemical substances. Under recent TSCA section 5(e) consent
orders, each PMN submitter is required to submit each study at least 14
weeks (earlier TSCA section 5(e) consent orders required submissions at
least 12 weeks) before reaching the specified production limit.
Listings of the tests specified in the TSCA section 5(e) consent orders
are included in Unit IV. The SNURs contain the same production volume
limits as the TSCA section 5(e) consent orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the
[[Page 45993]]
production limit must notify the Agency by submitting a SNUN at least
90 days in advance of commencement of non-exempt commercial manufacture
or processing.
Any request by EPA for the triggered and pended testing described
in the Consent Order was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substance. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
The recommended tests specified in Unit IV. of the proposed rule
may not be the only means of addressing the potential risks of the
chemical substance. However, submitting a SNUN without any test data
may increase the likelihood that EPA will take action under TSCA
section 5(e), particularly if satisfactory test results have not been
obtained from a prior PMN or SNUN submitter. EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VII. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn.
VIII. Economic Analysis
EPA evaluated the potential costs of establishing SNUN requirements
for potential manufacturers and processors of the chemical substance
during the development of the direct final rule. The Agency's complete
Economic Analysis is available in the docket under docket ID number
EPA-HQ-OPPT-2016-0207.
IX. Scientific Standards, Evidence, and Available Information
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the risk assessment documents included in the public docket. These
information sources supply information relevant to whether a particular
use would be a significant new use, based on relevant factors including
those listed under TSCA section 5(a)(2).
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this proposed significant new use rule, in Unit II and in the documents
noted above. EPA recognizes, based on the available information, that
there is variability and uncertainty in whether any particular
significant new use would actually present an unreasonable risk. For
precisely this reason, it is appropriate to secure a future notice and
review process for these uses, at such time as they are known more
definitely. The extent to which the various information, procedures,
measures, methods, protocols, methodologies or models used in EPA's
decision have been subject to independent verification or peer review
is adequate to justify their use, collectively, in the record for a
significant new use rule.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This action establishes a SNUR for the chemical substance that is
the subject of a PMN and 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 (PRA)
According to the 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
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 (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(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 SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
action.
[[Page 45994]]
This action 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 $8,300.
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 (UMRA)
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 UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
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 (NTTAA)
In addition, 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.
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).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 15, 2017.
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. In Sec. [emsp14]9.1, add the following section in numerical order
under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
721.10927............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10927 to subpart E to read as follows:
Sec. 721.10927 Bimodal mixture consisting of multi-walled carbon
nanotubes and other classes of carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
bimodal mixture consisting of multi-walled carbon nanotubes and other
classes of carbon nanotubes (PMN P-11-482) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)
(particulate), 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
[[Page 45995]]
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. A National
Institute for Occupational Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator
with an Assigned Protection Factor (APF) of at least 50 meets the
requirements of Sec. 721.63(a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). A significant new use is any
use involving an application method that generates a vapor, mist or
aerosol.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as specified in Sec.
721.90(b)(1) and (c)(1). Any predictable or purposeful release of a
manufacturing stream associated with any use of the substance from any
site is a significant new use other than the water releases described
in the manufacturing process of PMN P-11-482.
(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) through (e), (i), (j), 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.
[FR Doc. 2017-21237 Filed 10-2-17; 8:45 am]
BILLING CODE 6560-50-P