Significant New Use Rule for Phenol, 2,4- dimethyl-6-(1-methylpentadecyl)-, 41692-41697 [2012-17276]
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Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Rules and Regulations
permitted to move during the
enforcement period. Vessels remaining
in the regulated area during the
enforcement period are subject to
inspection and examination by Coast
Guard and other law enforcement
officials. Persons desiring to access their
vessels within the regulated area are
subject to security screenings.
(2) Hillsborough River. All waters of
Hillsborough River, including adjacent
lands 20 feet shoreward of the mean
high water mark of Hillsborough River,
south of an imaginary line between the
following points: Point 1 in position
27°56′44″ N, 82°27′37″ W; and Point 2
in position 27°56′44″ N, 82°27′33″ W.
All persons and vessels are prohibited
from entering or remaining within the
regulated area unless authorized by the
Captain of the Port St. Petersburg or a
designated representative.
(3) Seddon Channel. All waters of
Seddon Channel, including adjacent
lands 20 feet shoreward of the mean
high water mark of Seddon Channel,
north of an imaginary line between the
following points: Point 1 in position
27°55′52″ N, 82°27′13″ W; and Point 2
in position 27°55′54″ N, 82°27′08″ W.
All persons and vessels are prohibited
from entering or remaining within the
regulated area unless authorized by the
Captain of the Port St. Petersburg or a
designated representative.
(4) Sparkman Channel. All waters of
Sparkman Channel, including adjacent
lands 20 feet shoreward of the mean
high water mark of Sparkman Channel.
Recreational vessels are prohibited from
entering or remaining in the regulated
area unless authorized by the Captain of
the Port St. Petersburg or a designated
representative. Commercial vessels are
authorized to enter or transit the
regulated area, but will be subject to
compliance with security protocols
established by the Captain of the Port St.
Petersburg, including:
(i) Have an approved NOA submitted
in accordance with 33 CFR part 160 that
indicates a mooring at a facility located
within the security zone or at a facility
that requires transit of the zone;
(ii) Inspection and examination of all
commercial vessels and persons
requesting authorization to transit the
regulated area (including positive
identification checks); and
(iii) Embarkation of law enforcement
personnel during authorized regulated
area transits.
(5) Unnamed Channel North of Davis
Islands. All waters of the unnamed
channel north of Davis Islands,
including adjacent lands 20 feet
shoreward of the mean high water mark
of the unnamed channel north of Davis
Islands, east of an imaginary line
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between the following points: Point 1 in
position 27°56′16″ N, 82°27′40″ W; and
Point 2 in position 27°56′18″ N,
82°27′43″ W. All persons and vessels are
prohibited from entering or remaining
within the regulated area unless
authorized by the Captain of the Port St.
Petersburg or a designated
representative.
(6) Ybor Channel. All waters of Ybor
Channel, including adjacent lands 20
feet shoreward of the mean high water
mark of Ybor Channel. Recreational
vessels are prohibited from entering or
remaining in Ybor Channel unless
authorized by the Captain of the Port St.
Petersburg or a designated
representative. Commercial vessels are
authorized to enter or transit Ybor
Channel, but will be subject to
compliance with security protocols
established by the Captain of the Port St.
Petersburg, including:
(i) Have an approved NOA submitted
in accordance with 33 CFR part 160 that
indicates a mooring at a facility located
within the security zone or at a facility
that requires transit of the zone;
(ii) Inspection and examination of all
commercial vessels and persons
requesting authorization to transit the
regulated area (including positive
identification checks); and
(iii) Embarkation of law enforcement
personnel during authorized regulated
area transits.
(7) Ybor Turning Basin. All waters of
Ybor Turning Basin, including adjacent
lands 20 feet shoreward of the mean
high water mark of Ybor Turning Basin.
Recreational vessels are prohibited from
entering or remaining in Ybor Turning
Basin unless authorized by the Captain
of the Port St. Petersburg or a designated
representative. Commercial vessels are
authorized to enter or transit Ybor
Turning Basin, but will be subject to
compliance with security protocols
established by the Captain of the Port St.
Petersburg, including:
(i) Have an approved NOA submitted
in accordance with 33 CFR part 160 that
indicates a mooring at a facility located
within the security zone or at a facility
that requires transit of the zone;
(ii) Inspection and examination of all
commercial vessels and persons
requesting authorization to transit the
security zone (including positive
identification checks); and
(iii) Embarkation of law enforcement
personnel during authorized regulated
area transits.
(b) Definition. The term ‘‘designated
representative’’ means Coast Guard
Patrol Commanders, including Coast
Guard boat coxswains, petty officers,
and other officers operating Coast Guard
vessels, and Federal, state, and local
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officials designated by or assisting the
Captain of the Port St. Petersburg in the
enforcement of the regulated areas.
(c) Regulations. (1) All persons and
vessels desiring to enter or remain
within the regulated areas may contact
the Captain of the Port St. Petersburg by
telephone at (727) 824–7524, or a
designated representative via VHF radio
on channel 16, to request authorization.
A Port Community Information
Bulletin is available on the Coast Guard
internet web portal at https://
homeport.uscg.mil. Port Community
Information Bulletins are located under
the Port Directory tab in the Safety and
Security Alert links.
(2) If authorization to enter or remain
within the regulated areas is granted by
the Captain of the Port St. Petersburg or
a designated representative, all persons
and vessels receiving such authorization
must comply with the instructions of
the Captain of the Port St. Petersburg or
a designated representative.
Recreational vessels authorized to enter
the regulated areas may be subject to
boarding and inspection of the vessel
and persons onboard.
(3) The Coast Guard will provide
notice of the regulated areas by Local
Notice to Mariners, Broadcast Notice to
Mariners, public outreach, and on-scene
designated representatives.
(d) Effective Date. This rule is
effective from 12:01 p.m. on August 25,
2012 through 11:59 a.m. on August 31,
2012.
Dated: June 28, 2012.
S.L. Dickinson,
Captain, U.S. Coast Guard, Captain of the
Port.
[FR Doc. 2012–17086 Filed 7–13–12; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2011–0633; FRL–9349–4]
RIN 2070–AB27
Significant New Use Rule for Phenol,
2,4- dimethyl-6-(1-methylpentadecyl)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 identified as
phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209;
CAS No. 134701–20–5). This action
requires persons who intend to
SUMMARY:
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manufacture, import, or process the
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 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 August
15, 2012.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2011–0633. 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:
Abeer Hashem, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (202) 564–1117;
email address: hashem.abeer@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: TSCAHotline@epa.gov.
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DATES:
SUPPLEMENTARY INFORMATION:
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I. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, import,
process, or use the chemical substance
contained in this final rule. Potentially
affected entities may include, but are
not limited to:
• Manufacturers, importers, or
processors of the subject chemical
substance (NAICS codes 325 and
324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a final SNUR
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
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 for the
chemical substance identified as
phenol, 2,4-dimethyl-6-(1methylpentadecyl)-, (PMN P–94–209;
CAS No. 134701–20–5). This action
requires persons who intend to
manufacture, import, or process the
subject chemical substance for an
activity that is designated as a
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significant new use by this final rule to
notify EPA at least 90 days before
commencing that activity. This rule was
proposed in the Federal Register of
December 28, 2011 (76 FR 81437) (FRL–
9325–9). In response to the proposed
SNUR, EPA received two public
comments. One commenter stated that
‘‘phenol is not a safe product to use.’’
As discussed in Units II. and IV. of the
proposed rule, EPA did identify
potential hazards for the PMN substance
(which is a different chemical substance
than ‘‘phenol’’) but did not find a
potential unreasonable risk. EPA
proposed this SNUR to require
notification so that EPA could evaluate
potential risks from any new uses.
Another commenter stated that EPA
should include an exemption for worker
protection requirements when the PMN
substance was present in a mixture at
low concentrations, specifically at less
than 1.0 percent. The commenter also
stated that the SNUR should contain an
exemption from the requirements of the
rule including recordkeeping when it is
incorporated into certain substrates. The
commenter suggested these exemptions
because the PMN substance is often
used as an additive in thermoplastic
polymer matrices and in mixtures at
concentrations less than 1.0 percent.
Because EPA does not expect significant
risks from these activities, EPA will
include these exemptions in the final
rule. Therefore, the Agency is issuing a
final SNUR that:
1. Adds protection in the workplace
requirements under § 721.63 for dermal
protection.
2. Includes an exemption from the
requirements under § 721.63 when the
substance is present in a mixture less
than 1.0 percent.
3. Removes all release to water
requirements under § 721.90.
4. Includes an exemption from all
requirements of the rule including
recordkeeping once the PMN substance
has been incorporated into polymer
matrices.
5. Revises the recordkeeping
requirements under § 721.125 to reflect
the modified significant new uses.
This final SNUR requires persons to
notify EPA at least 90 days before
commencing the manufacture, import,
or processing of the chemical substance
identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)-, (PMN P–94–209,
CAS No.134701–20–5), for any activity
designated by this final SNUR as a
significant new use. Receipt of such
notices allows EPA to assess risks that
may be presented by the intended uses
and, if appropriate, to regulate the
proposed use before it occurs.
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B. What is the Agency’s authority for
taking this action?
export notification requirements in 40
CFR part 707, subpart D.
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including those listed in TSCA section
5(a)(2). Once EPA determines that a use
of a chemical substance is a significant
new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture,
import, or process the chemical
substance for that use. Persons who
must report are described in § 721.5.
III. Rationale and Objectives of the
Final Rule
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C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
final rule. Provisions relating to user
fees appear at 40 CFR part 700.
According to § 721.1(c), persons subject
to this SNUR must comply with the
same notice requirements and EPA
regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include
the information submission
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 2612)
import certification requirements
promulgated in Customs and Border
Patrol regulations at 19 CFR 12.118
through 12.127; see also 19 CFR 127.28.
Chemical importers must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA. For importers of the
chemical substance subject to this final
SNUR those requirements include the
SNUR. 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 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
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A. Rationale
During review of the PMN submitted
for the chemical substance phenol, 2,4dimethyl-6-(1-methylpentadecyl)-, EPA
concluded that one or more of the
criteria of concern established at
§ 721.170 were met, as discussed in
Units II. and IV. of the proposed rule (76
FR 81437).
B. Objectives
EPA is issuing this final 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 final rule:
• EPA will receive notice of any
person’s intent to manufacture, import,
or process a listed chemical substance
for the described significant new use
before that activity begins.
• EPA will have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing a listed chemical substance
for the described significant new use.
• EPA will be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
substance before the described
significant new use of that chemical
substance occurs, provided that
regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Inventory. Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
Internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
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• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorized EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance that is the subject to this final
SNUR, EPA considered relevant
information about the toxicity of the
chemical substance, likely human
exposure and environmental releases
associated with possible uses, taking
into consideration the four bulleted
TSCA section 5(a)(2) factors listed in
this unit, and the regulations at
§ 721.170 for issuing a SNUR after
receipt of a PMN.
V. Applicability of Rule to Uses
Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register
issue of April 24, 1990 (55 FR 17376),
EPA has decided that the intent of
TSCA section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication were considered
ongoing rather than new, it would be
difficult for EPA to establish SNUR
notice requirements because a person
could defeat the SNUR by initiating the
significant new use before the rule
became effective, and then argue that
the use was ongoing before the effective
date of the final rule.
Any person who began commercial
manufacture, import, or processing of
the chemical substance for any of the
significant new uses designated in the
proposed rule after the date of
publication of the proposed rule must
stop that activity before the effective
date of this final rule. To resume their
activities, these persons would have to
comply with all applicable SNUR notice
requirements and wait until the notice
review period, including any extensions
expires.
EPA has promulgated provisions to
allow persons to comply with this
SNUR before the effective date. If a
person meets the conditions of advance
compliance under § 721.45(h), the
person is considered exempt from the
requirements of the SNUR.
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:
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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
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Unit IV. of the proposed rule lists the
testing recommended by EPA for the
chemical substance phenol, 2,4
dimethyl-6-(1-methylpentadecyl)-.
Specifically, EPA has determined that a
dermal absorption study (Office of
Pollution Prevention and Toxics
(OPPTS) Test Guideline 870.3250)
would help characterize the health
effects of the PMN substance.
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 and test
reporting. To access the harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
The recommended tests 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.
• 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 § 721.1(c), persons
submitting a SNUN must comply with
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the same notice requirements and EPA
regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in
§ 720.50. SNUNs must be 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 §§ 721.25 and
720.40. 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, importers, and
processors of the chemical substance
subject to this final rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2011–0633.
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
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this final
rule. This listing of the OMB control
numbers and their subsequent
codification in the CFR satisfies the
display requirements of PRA and OMB’s
implementing regulations at 5 CFR part
1320. This Information Collection
Request (ICR) was previously subject to
public notice and comment prior to
OMB approval, and given the technical
nature of the table, EPA finds that
further notice and comment to amend it
is unnecessary. As a result, EPA finds
that there is ‘‘good cause’’ under section
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41695
553(b)(3)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), to
amend this table without further notice
and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action would not impose any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified
pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), that promulgation
of a SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this rule.
This rule is within the scope of the
February 18, 2012 certification. Based
on the economic analysis discussed in
Unit 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.
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D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
final rule. As such, EPA has determined
that this final rule does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of sections 202, 203, 204,
or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
E. Executive Order 13132
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This final rule does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This final rule does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
With Indian Tribal Governments
(65 FR 67249, November 9, 2000) do not
apply to this final rule.
wreier-aviles on DSK5TPTVN1PROD with RULES
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.
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I. National Technology Transfer and
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
X. Congressional Review Act
The Congressional Review Act,
5 U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This rule is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: June 30, 2012.
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.
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2. The table in § 9.1 is amended by
adding 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.
*
*
*
*
*
40 CFR Citation
*
*
OMB Control No.
*
*
*
Significant New Uses of Chemical
Substances
*
*
*
*
721.5725 .......................
*
*
*
*
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 § 721.5725 to subpart E to read
as follows:
■
§ 721.5725 Phenol, 2,4-dimethyl-6-(1methylpentadecyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209;
CAS No. 134701–20–5) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance after
it has been completely reacted (cured);
embedded or incorporated into a
polymer matrix that has been reacted
(cured); or embedded, encapsulated, or
incorporated into a permanent solid
matrix (does not include slurries) that is
not intended to undergo further
processing, except for mechanical
processing.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(2)(i), (a)(3), and (b) (concentration set
at 1.0 percent).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
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Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Rules and Regulations
(a), (b), (c), (d), and (e) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2012–17276 Filed 7–13–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2010–0846; FRL–9698–3]
Stay of the Effectiveness of
Requirements; Approval and
Promulgation of Implementation Plans;
New Mexico; Federal Implementation
Plan for Interstate Transport of
Pollution Affecting Visibility and Best
Available Retrofit Technology
Determination
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The EPA is granting an
administrative stay of the final rule
titled ‘‘Approval and Promulgation of
Implementation Plans; New Mexico;
Federal Implementation Plan for
Interstate Transport of Pollution
Affecting Visibility and Best Available
Retrofit Technology Determination’’
under the authority of the
Administrative Procedure Act (APA) for
90 days. Today’s action reflects this stay
in the Code of Federal Regulations.
DATES: Effective July 16, 2012. 40 CFR
52.1628 is stayed until October 15,
2012.
SUMMARY:
EPA has established a
docket for this action under Docket ID
No. EPA–R06–OAR–2010–0846. All
documents in the docket are listed in
the Federal eRulemaking portal index at
https://www.regulations.gov and are
available either electronically at https://
www.regulations.gov or in hard copy at
EPA Region 6, 1445 Ross Ave., Dallas,
TX, 75202–2733. To inspect the hard
copy materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
A reasonable fee may be charged for
copies.
wreier-aviles on DSK5TPTVN1PROD with RULES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Agustin Carbo-Lugo, EPA Region 6,
(214) 665–8037, CarboLugo.Agustin@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document wherever
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‘‘we,’’ ‘‘us,’’ ‘‘our,’’ or ‘‘the Agency’’ is
used, we mean the EPA. Unless
otherwise specified, when we say the
‘‘San Juan Generating Station,’’ or
‘‘SJGS,’’ we mean units 1, 2, 3, and 4,
inclusive.
I. Background
On August 22, 2011, the EPA
published a final rule disapproving a
portion of the State Implementation
Plan (SIP) revision received from the
State of New Mexico on September 17,
2007, for the purpose of addressing the
‘‘good neighbor’’ requirements of
section 110(a)(2)(D)(i) of the Clean Air
Act (CAA or Act) for the 1997 8-hour
ozone National Ambient Air Quality
Standards (NAAQS or standards) and
the 1997 fine particulate matter (PM2.5)
NAAQS (the ‘‘NM FIP Rule’’, 76 FR
52388). In that action, EPA disapproved
the New Mexico Interstate Transport SIP
provisions that address the requirement
of section 110(a)(2)(D)(i)(II) that
emissions from New Mexico sources do
not interfere with measures required in
the SIP of any other state under part C
of the CAA to protect visibility. We
found that New Mexico sources, except
the San Juan Generating Station (SJGS),
were sufficiently controlled to eliminate
interference from those sources with the
visibility programs of other states. EPA
promulgated a Federal Implementation
Plan (FIP) requiring the implementation
of nitrogen oxides (NOX) and sulfur
dioxide (SO2) emission limits necessary
at the San Juan Generating Station to
prevent such interference. This FIP also
addresses the Regional Haze (RH) Best
Available Retrofit Technology (BART)
requirement for NOX for SJGS. In
addition, EPA implemented sulfuric
acid (H2SO4) hourly emission limits at
the SJGS, to minimize the contribution
of this compound to visibility
impairment. Finally, we found that
compliance with the NOX, SO2, and
H2SO4 emission limits must be within 5
years of the effective date of our final
rule consistent with the requirements of
the regional haze regulations.
Petitions for judicial review of the
final rule were subsequently filed in the
United States Court of Appeals for the
Tenth Circuit. The petitioners bringing
those challenges are WildEarth
Guardians, Public Service of New
Mexico (PNM), and New Mexico
Governor Susana Martinez with the
New Mexico Environment Department.
By a letter to the EPA Administrator,
dated April 26, 2012, the Governor of
New Mexico requested ‘‘a short term
(90-day) stay’’ of the federal
implementation plan to evaluate the
potential for alternatives to the rule
requirements. She presents a stay as
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41697
being necessary for ‘‘meaningful,
productive negotiations’’ that may lead
to an avoidance of litigation. By a letter
to the acting Regional Administrator of
EPA Region 6, dated May 8, 2012, PNM
also requested ‘‘an opportunity to
engage in productive discussions as
proposed by Governor Martinez.’’
We support discussions of any
alternatives to the federal
implementation plan that would be
consistent with regional haze rule
requirements and the requirements of
section 110(a)(2)(D)(i)(II) of the CAA. If
such an alternative arises through
discussions with the State of New
Mexico, as well as other stakeholders, it
may provide a basis for submittal by the
state of a revised SIP, withdrawal of the
FIP, and the resolution of pending
litigation.
II. Today’s Final Rule
A. Issuance of a Stay and Delay of the
Effectiveness of the NM FIP Rule
Pursuant to section 705 of the APA,
the EPA hereby stays the effectiveness
of the NM FIP Rule for a period of 90
days from the date of publication of this
Federal Register notice. By this action,
we are staying the effectiveness of the
rule published in the Federal Register
on August 22, 2011 (76 FR 52388). This
stay of effectiveness will remain in
place for 90 days from today. This
action adds a note to 40 CFR 52.1628
that there is a 90 day stay of the
effectiveness of the NM FIP Rule, but, in
its substance, it does not alter any future
compliance requirements. There are no
compliance obligations under the terms
of the NM FIP that arise during the 90
day period.
Under section 705 of the APA, ‘‘an
agency * * * may postpone the
effective date of [an] action taken by it
pending judicial review.’’ This source of
authority requires an Agency finding
that ‘‘justice requires’’ a temporary stay
of rule requirements. Accordingly, as
groundwork for the mentioned
discussions among the Agency, the State
of New Mexico, and other stakeholders,
EPA now finds that justice requires a
90-day stay of the rule’s effectiveness.
Our temporary stay of the effectiveness
of the NM FIP Rule applies only to any
requirements established in 40 CFR
52.1628 during the 90-day stay and does
not extend the ultimate compliance
timeframe set out in the rule, which is
a statutory requirement under CAA
section 169A(b)(2)(A). Nevertheless,
EPA intends to undertake a future
rulemaking to either: (1) Extend the
compliance time for the NM FIP to
accommodate the stay; or (2) account for
an alternative proposal. If the
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Agencies
[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Rules and Regulations]
[Pages 41692-41697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17276]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0633; FRL-9349-4]
RIN 2070-AB27
Significant New Use Rule for Phenol, 2,4- dimethyl-6-(1-
methylpentadecyl)-
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
identified as phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- (PMN P-94-
209; CAS No. 134701-20-5). This action requires persons who intend to
[[Page 41693]]
manufacture, import, or process the 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 would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it occurs.
DATES: This final rule is effective August 15, 2012.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2011-0633. 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: Abeer Hashem, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-1117; email
address: hashem.abeer@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,
import, process, or use the chemical substance contained in this final
rule. Potentially affected entities may include, but are not limited
to:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemicals subject to a final SNUR
must certify their compliance with the SNUR requirements. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance 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 as
phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, (PMN P-94-209; CAS No.
134701-20-5). This action requires persons who intend to manufacture,
import, or process the subject 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. This rule was
proposed in the Federal Register of December 28, 2011 (76 FR 81437)
(FRL-9325-9). In response to the proposed SNUR, EPA received two public
comments. One commenter stated that ``phenol is not a safe product to
use.'' As discussed in Units II. and IV. of the proposed rule, EPA did
identify potential hazards for the PMN substance (which is a different
chemical substance than ``phenol'') but did not find a potential
unreasonable risk. EPA proposed this SNUR to require notification so
that EPA could evaluate potential risks from any new uses. Another
commenter stated that EPA should include an exemption for worker
protection requirements when the PMN substance was present in a mixture
at low concentrations, specifically at less than 1.0 percent. The
commenter also stated that the SNUR should contain an exemption from
the requirements of the rule including recordkeeping when it is
incorporated into certain substrates. The commenter suggested these
exemptions because the PMN substance is often used as an additive in
thermoplastic polymer matrices and in mixtures at concentrations less
than 1.0 percent. Because EPA does not expect significant risks from
these activities, EPA will include these exemptions in the final rule.
Therefore, the Agency is issuing a final SNUR that:
1. Adds protection in the workplace requirements under Sec. 721.63
for dermal protection.
2. Includes an exemption from the requirements under Sec. 721.63
when the substance is present in a mixture less than 1.0 percent.
3. Removes all release to water requirements under Sec. 721.90.
4. Includes an exemption from all requirements of the rule
including recordkeeping once the PMN substance has been incorporated
into polymer matrices.
5. Revises the recordkeeping requirements under Sec. 721.125 to
reflect the modified significant new uses.
This final SNUR requires persons to notify EPA at least 90 days
before commencing the manufacture, import, or processing of the
chemical substance identified as phenol, 2,4-dimethyl-6-(1-
methylpentadecyl)-, (PMN P-94-209, CAS No.134701-20-5), for any
activity designated by this final SNUR as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs.
[[Page 41694]]
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use. 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 this SNUR must comply
with the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
Chemical importers are subject to the TSCA section 13 (15 U.S.C.
2612) import certification requirements promulgated in Customs and
Border Patrol regulations at 19 CFR 12.118 through 12.127; see also 19
CFR 127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA. For importers of the chemical substance subject to this final
SNUR those requirements include the SNUR. 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 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.
III. Rationale and Objectives of the Final Rule
A. Rationale
During review of the PMN submitted for the chemical substance
phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, EPA concluded that one or
more of the criteria of concern established at Sec. 721.170 were met,
as discussed in Units II. and IV. of the proposed rule (76 FR 81437).
B. Objectives
EPA is issuing this final 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 final rule:
EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at https://www.epa.gov/opptintr/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 that is the subject to this final SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposure and environmental releases associated
with possible uses, taking into consideration the four bulleted TSCA
section 5(a)(2) factors listed in this unit, and the regulations at
Sec. 721.170 for issuing a SNUR after receipt of a PMN.
V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register issue of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
effective, and then argue that the use was ongoing before the effective
date of the final rule.
Any person who began commercial manufacture, import, or processing
of the chemical substance for any of the significant new uses
designated in the proposed rule after the date of publication of the
proposed rule must stop that activity before the effective date of this
final rule. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including any extensions expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec. 721.45(h), the person is considered
exempt from the requirements of the SNUR.
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:
[[Page 41695]]
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. of the proposed rule
lists the testing recommended by EPA for the chemical substance phenol,
2,4 dimethyl-6-(1-methylpentadecyl)-. Specifically, EPA has determined
that a dermal absorption study (Office of Pollution Prevention and
Toxics (OPPTS) Test Guideline 870.3250) would help characterize the
health effects of the PMN substance. 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 and test reporting. To access the harmonized test
guidelines referenced in this document electronically, please go to
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
The recommended tests 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.
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. [emsp14]721.1(c), persons submitting a SNUN must
comply with the same notice requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in Sec. 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance subject to this final rule. EPA's complete
economic analysis is available in the docket under docket ID number
EPA-HQ-OPPT-2011-0633.
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
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA is amending the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this final rule. This listing of
the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320. This Information Collection Request
(ICR) was previously subject to public notice and comment prior to OMB
approval, and given the technical nature of the table, EPA finds that
further notice and comment to amend it is unnecessary. As a result, EPA
finds that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this
table without further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that
promulgation of a SNUR does not have a significant economic impact on a
substantial number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
rule.
This rule is within the scope of the February 18, 2012
certification. Based on the economic analysis discussed in Unit 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.
[[Page 41696]]
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this final rule.
As such, EPA has determined that this final rule does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This final rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule does not significantly nor uniquely affect the communities
of Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled Consultation and Coordination With
Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply
to this final rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
Protection of Children From Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use and
because this action is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions To Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 30, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. The table in Sec. 9.1 is amended by adding the following section in
numerical order under the undesignated center heading ``Significant New
Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR Citation OMB Control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.5725............................................ 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. 721.5725 to subpart E to read as follows:
Sec. [emsp14]721.5725 Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
rule do not apply to quantities of the PMN substance after it has been
completely reacted (cured); embedded or incorporated into a polymer
matrix that has been reacted (cured); or embedded, encapsulated, or
incorporated into a permanent solid matrix (does not include slurries)
that is not intended to undergo further processing, except for
mechanical processing.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(2)(i), (a)(3), and (b) (concentration set at 1.0 percent).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125
[[Page 41697]]
(a), (b), (c), (d), and (e) are applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2012-17276 Filed 7-13-12; 8:45 am]
BILLING CODE 6560-50-P