Significant New Use Rule for Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-, 12083-12087 [2015-05069]
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Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Rules and Regulations
The docket for this
deviation, [USCG–2015–0065] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140, on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC, 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Joe M. Arca,
Project Officer, First Coast Guard
District, telephone (212) 514–4336,
joe.m.arca@uscg.mil. If you have
questions on viewing the docket, call
Cheryl Collins, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION: The
Metro-North (Park Avenue) Bridge
across the Harlem River, mile 2.1, at
New York City, New York, has a vertical
clearance in the closed position of 25
feet at mean high water and 30 feet at
mean low water. The existing bridge
operating regulations are found at 33
CFR 117.789(c).
The waterway is transited by
commercial vessels.
The bridge owner, Metro-North,
requested a temporary deviation from
the normal operating schedule to
facilitate electrical repairs as a result of
damage incurred from Hurricane Sandy.
Under this temporary deviation, the
Metro-North (Park Avenue) Bridge may
remain in the closed position from
March 13, 2015 through May 21, 2015.
The habitual users can transit under
the bridge without requesting bridge
openings due to the high vertical
clearance under the bridge.
There are no alternate routes for
vessel traffic; however, vessels that can
pass under the closed draw during this
closure may do so at all times. The
bridge may not be opened in the event
of an emergency.
The Coast Guard will inform the users
of the waterways through our Local and
Broadcast Notice to Mariners of the
change in operating schedule for the
bridge so that vessels can arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
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ADDRESSES:
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Dated: February 23, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist,
First Coast Guard District.
[FR Doc. 2015–05233 Filed 3–5–15; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2015–0085]
Drawbridge Operation Regulations;
Cheesequake Creek, Morgan, NJ
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the operation of
the New Jersey Transit Rail Operations
(NJTRO) railroad bridge across
Cheesequake Creek, mile 0.2, at Morgan,
New Jersey. This deviation is necessary
to allow the bridge owner to perform
structural repairs at the bridge. This
deviation allows the bridge to remain
closed on three consecutive weekends.
DATES: This deviation is effective from
6 a.m. on March 14, 2015 through 7 p.m.
on March 28, 2015.
ADDRESSES: The docket for this
deviation, [USCG–2015–0085] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140, on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC, 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Joe M. Arca,
Project Officer, First Coast Guard
District, telephone (212) 514–4336,
joe.m.arca@uscg.mil. If you have
questions on viewing the docket, call
Cheryl Collins, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION: The
NJTRO railroad bridge across
Cheesequake Creek, mile 0.2, at Morgan,
New Jersey, has a vertical clearance in
the closed position of 3 feet at mean
high water and 8 feet at mean low water.
SUMMARY:
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The existing bridge operating
regulations are found at 33 CFR
117.709(b).
The waterway is transited by seasonal
recreational vessels of various sizes.
The bridge owner, NJTRO, requested
a temporary deviation from the normal
operating schedule to facilitate
structural repairs at the bridge.
Under this temporary deviation the
NJTRO railroad bridge shall remain in
the closed position for three consecutive
weekends from 6 a.m. on Saturday
through 7 p.m. on Sunday on the
following dates: March 14 and 15,
March 21 and 22, and March 28 and 29,
2015.
The draw shall maintain its normal
operating schedule at all other times.
There are no alternate routes for
vessel traffic; however, vessels that can
pass under the closed draw during this
closure may do so at all times. The
bridge may be opened in the event of an
emergency.
The Coast Guard will inform the users
of the waterways through our Local and
Broadcast Notice to Mariners of the
change in operating schedule for the
bridge so that vessels can arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: February 23, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist,
First Coast Guard District.
[FR Doc. 2015–05234 Filed 3–5–15; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2011–0941; FRL–9922–30]
RIN 2070–AB27
Significant New Use Rule for Pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is finalizing a significant
new use rule (SNUR) under the Toxic
Substances Control Act (TSCA) for the
chemical substance Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- that was the
SUMMARY:
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subject of premanufacture notice (PMN)
P–07–204. This action requires persons
who intend to manufacture (including
import) this 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. The required
notification will 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 April
6, 2015.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2011–0941, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket, available
at https://www.epa.gov/dockets.
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. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substance Pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- (PMN P–07–204;
CAS No. 870778–34–0) contained in
this final rule. 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:
• Manufacturers 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 these SNURs
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of this final rule are
subject to the export notification
provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see § 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, under
TSCA section 5(a)(2), for the chemical
substance Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- (PMN P–07–204;
CAS No. 870778–34–0) codified at 40
CFR 721.10509. This final rule 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 September
21, 2012 (77 FR 58666) (FRL–9357–2),
EPA issued a direct final SNUR for the
chemical substance. EPA received
notice of intent to submit adverse
comments for the direct final SNUR. In
response to that notification a rule was
proposed in the Federal Register issue
of January 23, 2013 (78 FR 4806) (FRL–
6369–9). In response to the proposed
rule, EPA received one public comment
from the submitter of PMN P–07–204.
The comment noted that in the time
period between filing of a Notice of
Commencement of Manufacture or
Import in March 2008, and the time of
publication of the direct final SNUR in
September 2012, the company had
entered into an industrial solvent use
that did not specifically fall within the
scope of the 40 CFR 721.80(j) (the
confidential uses identified in the
amended premanufacture notice)
significant new use reporting
requirement contained in the rule.
Therefore, the use was considered an
ongoing use at the time of the direct
final SNUR.
Further, the commenter mentioned
the intent to submit several health and
safety studies on the PMN substance
that were completed after the expiration
of the PMN review period. The
following table identifies the studies
that were subsequently submitted to the
Agency for review and the results of
EPA’s review of those studies:
Study
EPA findings from study
5-day Inhalation toxicity test in rats ..........................................................
Acute dermal toxicity test in rats ..............................................................
Uncertain increase in liver weights at highest dose.
No Observed Adverse Effect Level (NOAEL) of 2,000 milligram/kilogram/day (mg/kg/day).
Not an eye irritant.
Not a skin sensitizer.
Indications of ability to activate the xenobiotic nuclear receptor CAR
(constitutive androstane receptor), but of uncertain significance relative to ability to affect clinical chemistry endpoints.
Not a skin irritant.
Lowest Observed Adverse Effect Level (LOAEL) of 495 parts per million (ppm) based on liver effects.
Uncertain significance.
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Acute eye irritation/corrosion test in rabbits .............................................
Assessment of contact hypersensitivity in the mouse .............................
Color microarray analysis of liver RNA ....................................................
Primary skin irritation/corrosion test in rabbits. ........................................
Sub-acute (29-day) inhalation toxicity test in rats ....................................
Analysis of the effect on primary cell cultures (low potency peroxisome
proliferator-activated receptor (PPAR) agonist).
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Agency review of the 29-day
inhalation toxicity study, which
demonstrated liver effects, along with
the perfluorochemical analog data cited
in the proposed SNUR, demonstrate the
concern cited in the proposed SNUR for
neurotoxicity and liver effects as a result
of unprotected occupational exposures
via the dermal route. Therefore, the
Agency is issuing a final SNUR as
proposed that designates as a significant
new use manufacture or processing of
the substance without impervious
gloves, where there is a potential for
dermal exposure, and simplifies the
wording in the significant new use
designation under 40 CFR 721.80 to
encompass the ongoing use as follows:
‘‘A significant new use is any use of the
substance other than for the specific
confidential industrial solvent uses
identified in the amended
premanufacture notice (PMN).’’
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B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including those listed in TSCA section
5(a)(2). Once EPA determines that a use
of a chemical substance is a significant
new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture or
process the chemical substance for that
use. Persons who must report are
described in § 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 final 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), (2), (3), and (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
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is required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
III. Rationale and Objectives of the
Final Rule
A. Rationale
During review of the PMN for the
chemical substance Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- (PMN P–07–204;
CAS No. 870778–34–0), EPA
determined that one or more of the
criteria of concern established at
§ 721.170 were met. For additional
discussion of the rationale for the SNUR
on this chemical, see Units II., IV., and
V. of the proposed rule.
B. Objectives
EPA is issuing this final SNUR for the
chemical substance Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- (PMN P–07–204;
CAS N. 870778–34–0) because the
Agency wants to achieve the following
objectives with regard to the significant
new uses designated in this final rule:
• EPA will receive notice of any
person’s intent to manufacture or
process a listed chemical substance for
the described significant new use before
that activity begins.
• EPA will have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing a
listed chemical substance for the
described significant new use.
• EPA will be able to regulate
prospective manufacturers or processors
of a listed chemical substance before the
described significant new use of that
chemical substance occurs, provided
that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(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.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
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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 pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)- (PMN P–07–204;
CAS No. 870778–34–0), EPA considered
relevant information about the toxicity
of the chemical substances, likely
human exposures and environmental
releases associated with possible uses,
and the four bulleted TSCA section
5(a)(2) factors listed in this unit.
V. Applicability of the Significant New
Use Designation
If uses begun after the proposed rule
was published were considered ongoing
rather than new, any person could
defeat the SNUR by initiating the
significant new use before the final rule
was issued. Therefore EPA has
designated the date of publication of the
proposed rule as the cutoff date for
determining whether the new use is
ongoing. Consult the Federal Register
Notice of April 24, 1990 (55 FR 17376,
FRL 3658–5) for a more detailed
discussion of the cutoff date for ongoing
uses.
Any person who began commercial
manufacture or processing of the
chemical substance identified as
pentane, 1,1,1,2,3,3-hexafluoro-4(1,1,2,3,3,3-hexafluoropropoxy)- (PMN
P–07–204; CAS No. 870778–34–0) 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.
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VI. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Recommended testing that would
address the criteria of concern of
§ 721.170 can be found in Unit IV. of the
proposed rule. Descriptions of tests are
provided only for informational
purposes. EPA strongly encourages
persons, before performing any testing,
to consult with the Agency pertaining to
protocol selection.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
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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/opptintr/newchems.
VIII. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
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of the chemical substance during the
development of the direct final rule.
EPA’s complete economic analysis is
available in the docket under docket ID
number EPA–HQ–OPPT–2011–0941.
IX. Statutory and Executive Order
Reviews
A. Executive Order 12866
This final rule establishes 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 (PRA)
According to PRA (44 U.S.C. 3501 et
seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this final
rule. This listing of the OMB control
numbers and their subsequent
codification in the CFR satisfies the
display requirements of PRA and OMB’s
implementing regulations at 5 CFR part
1320. This Information Collection
Request (ICR) was previously subject to
public notice and comment prior to
OMB approval, and given the technical
nature of the table, EPA finds that
further notice and comment to amend it
is unnecessary. As a result, EPA finds
that there is ‘‘good cause’’ under section
553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to
amend this table without further notice
and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
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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 final
rule.
This final rule is within the scope of
the February 18, 2012 certification.
Based on the Economic Analysis
discussed in Unit VIII. 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 action 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:\FR\FM\06MRR1.SGM
06MRR1
Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Rules and Regulations
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 action 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.
rmajette on DSK2TPTVN1PROD with RULES
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).
VerDate Sep<11>2014
15:26 Mar 05, 2015
Jkt 235001
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this final 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 final rule in the
Federal Register. This action 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: February 23, 2015.
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:
■
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.
*
*
*
*
*
OMB Control
No.
40 CFR citation
*
*
*
*
*
Significant New Uses of Chemical
Substances
*
*
*
721.10509 .............................
PO 00000
*
*
Frm 00015
*
Fmt 4700
*
*
Sfmt 9990
*
*
*
*
12087
*
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 § 721.10509 to subpart E to
read as follows:
■
§ 721.10509 Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
pentane, 1,1,1,2,3,3-hexafluoro-4(1,1,2,3,3,3-hexafluoropropoxy)- (PMN
P–07–204; CAS No. 870778–34–0) 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)(3),
(b)(concentration set at 1.0 percent), and
(c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use of the substance other
than for the specific confidential
industrial solvent uses identified in the
amended premanufacture notice (PMN).
(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), and (i) 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. 2015–05069 Filed 3–5–15; 8:45 am]
BILLING CODE 6560–50–P
*
2070–0012
*
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]]>Agencies
[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Rules and Regulations]
[Pages 12083-12087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05069]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0941; FRL-9922-30]
RIN 2070-AB27
Significant New Use Rule for Pentane, 1,1,1,2,3,3-hexafluoro-4-
(1,1,2,3,3,3-hexafluoropropoxy)-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is finalizing a significant new use rule (SNUR) under the
Toxic Substances Control Act (TSCA) for the chemical substance Pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- that was the
[[Page 12084]]
subject of premanufacture notice (PMN) P-07-204. This action requires
persons who intend to manufacture (including import) this 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. The required notification will 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 April 6, 2015.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2011-0941, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket, available at https://www.epa.gov/dockets.
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. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substance Pentane, 1,1,1,2,3,3-hexafluoro-
4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-204; CAS No. 870778-34-0)
contained in this final rule. 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:
Manufacturers 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 these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this final rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
II. Background
A. What action is the agency taking?
EPA is finalizing a SNUR, under TSCA section 5(a)(2), for the
chemical substance Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-
hexafluoropropoxy)- (PMN P-07-204; CAS No. 870778-34-0) codified at 40
CFR 721.10509. This final rule 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 September 21, 2012 (77 FR 58666) (FRL-
9357-2), EPA issued a direct final SNUR for the chemical substance. EPA
received notice of intent to submit adverse comments for the direct
final SNUR. In response to that notification a rule was proposed in the
Federal Register issue of January 23, 2013 (78 FR 4806) (FRL-6369-9).
In response to the proposed rule, EPA received one public comment from
the submitter of PMN P-07-204.
The comment noted that in the time period between filing of a
Notice of Commencement of Manufacture or Import in March 2008, and the
time of publication of the direct final SNUR in September 2012, the
company had entered into an industrial solvent use that did not
specifically fall within the scope of the 40 CFR 721.80(j) (the
confidential uses identified in the amended premanufacture notice)
significant new use reporting requirement contained in the rule.
Therefore, the use was considered an ongoing use at the time of the
direct final SNUR.
Further, the commenter mentioned the intent to submit several
health and safety studies on the PMN substance that were completed
after the expiration of the PMN review period. The following table
identifies the studies that were subsequently submitted to the Agency
for review and the results of EPA's review of those studies:
------------------------------------------------------------------------
Study EPA findings from study
------------------------------------------------------------------------
5-day Inhalation toxicity test in rats. Uncertain increase in liver
weights at highest dose.
Acute dermal toxicity test in rats..... No Observed Adverse Effect
Level (NOAEL) of 2,000
milligram/kilogram/day (mg/kg/
day).
Acute eye irritation/corrosion test in Not an eye irritant.
rabbits.
Assessment of contact hypersensitivity Not a skin sensitizer.
in the mouse.
Color microarray analysis of liver RNA. Indications of ability to
activate the xenobiotic
nuclear receptor CAR
(constitutive androstane
receptor), but of uncertain
significance relative to
ability to affect clinical
chemistry endpoints.
Primary skin irritation/corrosion test Not a skin irritant.
in rabbits..
Sub-acute (29-day) inhalation toxicity Lowest Observed Adverse Effect
test in rats. Level (LOAEL) of 495 parts per
million (ppm) based on liver
effects.
Analysis of the effect on primary cell Uncertain significance.
cultures (low potency peroxisome
proliferator-activated receptor (PPAR)
agonist).
------------------------------------------------------------------------
[[Page 12085]]
Agency review of the 29-day inhalation toxicity study, which
demonstrated liver effects, along with the perfluorochemical analog
data cited in the proposed SNUR, demonstrate the concern cited in the
proposed SNUR for neurotoxicity and liver effects as a result of
unprotected occupational exposures via the dermal route. Therefore, the
Agency is issuing a final SNUR as proposed that designates as a
significant new use manufacture or processing of the substance without
impervious gloves, where there is a potential for dermal exposure, and
simplifies the wording in the significant new use designation under 40
CFR 721.80 to encompass the ongoing use as follows: ``A significant new
use is any use of the substance other than for the specific
confidential industrial solvent uses identified in the amended
premanufacture notice (PMN).''
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use. Persons who must report
are described in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the final 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), (2), (3), and (5), and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA may take regulatory action under TSCA
section 5(e), 5(f), 6, or 7 to control the activities for which it has
received the SNUN. If EPA does not take action, EPA is required under
TSCA section 5(g) to explain in the Federal Register its reasons for
not taking action.
III. Rationale and Objectives of the Final Rule
A. Rationale
During review of the PMN for the chemical substance Pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-
204; CAS No. 870778-34-0), EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met. For
additional discussion of the rationale for the SNUR on this chemical,
see Units II., IV., and V. of the proposed rule.
B. Objectives
EPA is issuing this final SNUR for the chemical substance Pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-
204; CAS N. 870778-34-0) because the Agency wants to achieve the
following objectives with regard to the significant new uses designated
in this final rule:
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (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/.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-
hexafluoropropoxy)- (PMN P-07-204; CAS No. 870778-34-0), EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
V. Applicability of the Significant New Use Designation
If uses begun after the proposed rule was published were considered
ongoing rather than new, any person could defeat the SNUR by initiating
the significant new use before the final rule was issued. Therefore EPA
has designated the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing. Consult the
Federal Register Notice of April 24, 1990 (55 FR 17376, FRL 3658-5) for
a more detailed discussion of the cutoff date for ongoing uses.
Any person who began commercial manufacture or processing of the
chemical substance identified as pentane, 1,1,1,2,3,3-hexafluoro-4-
(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-204; CAS No. 870778-34-0)
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 [emsp14]721.45(h), the
person would be considered to have met the requirements of the final
SNUR for those activities.
[[Page 12086]]
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Recommended testing that would address the criteria of concern of
Sec. 721.170 can be found in Unit IV. of the proposed rule.
Descriptions of tests are provided only for informational purposes. EPA
strongly encourages persons, before performing any testing, to consult
with the Agency pertaining to protocol selection.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
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 Sec. 721.25. E-PMN software is
available electronically at https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA has 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. EPA's
complete economic analysis is available in the docket under docket ID
number EPA-HQ-OPPT-2011-0941.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
This final rule establishes 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 (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this final rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (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
final rule.
This final rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit VIII.
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 action 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.).
[[Page 12087]]
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 action 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).
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this final 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 final rule in the Federal Register. This action 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: February 23, 2015.
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. 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.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB Control No.
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * *
721.10509.............................................. 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. 721.10509 to subpart E to read as follows:
Sec. 721.10509 Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-
hexafluoropropoxy)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-
204; CAS No. 870778-34-0) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 1.0 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any use of the
substance other than for the specific confidential industrial solvent
uses identified in the amended premanufacture notice (PMN).
(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), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
[FR Doc. 2015-05069 Filed 3-5-15; 8:45 am]
BILLING CODE 6560-50-P
