Proposed Significant New Use Rule for Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, 81437-81441 [2011-33256]
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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules
Board of Patent Appeals and
Interferences was filed under 35 U.S.C.
134 and § 41.31 of this title and ending
on the date an appeal brief in
compliance with 41.37 or a request for
continued examination in compliance
with § 1.114 was filed;
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Dated: December 15, 2011.
David J. Kappos,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2011–33150 Filed 12–27–11; 8:45 am]
BILLING CODE 3510–16–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2011–0633; FRL–9325–9]
RIN 2070–AB27
Proposed Significant New Use Rule for
Phenol, 2,4-dimethyl-6-(1methylpentadecyl)Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the chemical substance
identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209;
CAS No. 134701–20–5). This action
would require persons who intend to
manufacture, import, or process the
substance for an activity that is
designated as a significant new use by
this proposed rule to notify EPA at least
90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
that activity before it occurs.
DATES: Comments must be received on
or before January 27, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2011–0633, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
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SUMMARY:
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Rm. 6428, 1201 Constitution Ave. NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2011–0633.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2011–0633. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
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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. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, import,
process, or use the chemical substance
contained in this proposed rule.
Potentially affected entities may
include, but are not limited to:
• Manufacturers, importers, or
processors of the subject chemical
substance (NAICS codes 325 and
324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 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
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U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a final SNUR
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
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vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
Under section 5(a)(2) of TSCA, EPA is
re-proposing a SNUR previously
proposed for phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209;
CAS No. 134701–20–5) in the Federal
Register of September 9, 1998 (63 FR
48157) (FRL–6020–8) but which was not
finalized. In the 1998 proposed SNUR,
based on submitted test data, EPA
expressed concerns for liver toxicity,
kidney toxicity, adrenal toxicity, and
blood toxicity. Additionally, based on
submitted test data and analogy to
phenols, EPA was also concerned that
toxicity to aquatic organisms would
occur at concentrations as low as 1 part
per billion (ppb). EPA determined that
use of the substance as described in the
Premanufacture Notice (PMN) did not
present an unreasonable risk because
workers would not be subject to
significant dermal exposures and there
were no significant environmental
releases. EPA also determined that other
potential uses of the substance may
result in significant dermal exposures to
workers and significant environmental
releases. Based on this information, the
PMN substance met the concern criteria
at § 721.170 (b)(3)(i) and (b)(4)(i). In the
1998 proposed SNUR, EPA proposed
worker protection requirements as
specified in § 721.63 (a)(2)(i) and (a)(3),
release to water restrictions as specified
in § 721.90 (a)(1), (b)(1), and (c)(1) and
associated recordkeeping requirements.
Recently, EPA re-evaluated the
information now available on phenol,
2,4-dimethyl-6-(1-methylpentadecyl)-.
Since the PMN was initially reviewed,
the Agency’s Ecological Structure
Activity Relationships (EcoSAR) dataset
for phenols has been significantly
updated to include 203 chemicals, up
from 78 chemicals. The additional
number of data points has increased the
robustness of the category, which has
changed the underlying Quantitative
Structure Activity Relationships
(QSAR). As a result, when the most
recent version of EcoSAR was run for
phenol, 2,4-dimethyl-6-(1methylpentadecyl)- in 2011, the
program predicted no adverse
ecotoxicological effects at saturation for
this substance. Additionally, measured
water solubility data submitted to the
Agency subsequent to the 1998 proposal
support the new EcoSAR prediction of
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no expected acute or chronic adverse
ecological effects.
Therefore, based upon the new
EcoSAR predictions and the measured
water solubility data, EPA now
concludes that the ecological hazard
and risk of this substance are low. EPA
no longer determines that this substance
may present an unreasonable risk to the
aquatic environment. As a result EPA,
based on the new data received and the
Agency’s predictive tools, no longer
finds that the PMN substance meets the
concern criteria at § 721.170 (b)(4)(i).
Therefore, EPA is re-proposing this
SNUR, retaining the previously
proposed worker protection
requirements specified in § 721.63
(a)(2)(i) and (a)(3), while removing the
proposed release to water restrictions
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
This proposed SNUR would require
persons to notify EPA at least 90 days
before commencing the manufacture,
import, or processing of the chemical
substance identified as phenol, 2,4dimethyl-6-(1-methyl pentadecyl)-,
(PMN P–94–209; CAS No.134701–20–5),
for any activity preliminarily designated
by this proposed 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. The record
established for this proposed SNUR is
available in the docket under Docket ID
number EPA–HQ–OPPT–2011–0633.
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 § 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
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
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§ 721.1(c), persons subject to these
SNURs must comply with the same
notice requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the
regulations at 40 CFR part 720. Once
EPA receives a SNUN, EPA may take
regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities
for which it has received the SNUN. If
EPA does not take action, EPA is
required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
III. Significant New Use Determination
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Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorized EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance that is the subject of this
proposed SNUR, EPA considered
relevant information about the toxicity
of the chemical substance, likely human
exposures and environmental releases
associated with possible uses, taking
into consideration the four bulleted
TSCA section 5(a)(2) factors listed in
this unit.
IV. Substance Subject to This Proposed
Rule
EPA is proposing to establish
significant new use and recordkeeping
requirements for the chemical substance
identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (P–94–209). In this
unit, EPA provides the following
information for this chemical substance:
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PMN Number P–94–209
Chemical name: Phenol 2,4-dimethyl6-(1-methylpentadecyl)-.
Chemical Abstracts Service (CAS)
number: 134701–20–5.
Basis for action: The PMN states that
the substance will be used as an
antioxidant. EPA is not aware of
additional uses of this PMN chemical
substance. Based on submitted test data,
there is concern for liver toxicity,
kidney toxicity, adrenal toxicity, and
blood toxicity. However, after review of
the PMN EPA determined that use of the
substance as described in the PMN did
not present an unreasonable risk
because workers would not be subject to
significant dermal exposures. EPA has
determined that other potential uses of
the substance may result in significant
dermal exposures to workers. Based on
this information the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(i).
Recommended testing: EPA has
determined that a dermal absorption
study (OPPTS Test Guideline 870.3250)
would help characterize the health
effects of the PMN substance. Test
reports should include protocols
approved by the EPA, certificate of
analysis for the test substance, raw data,
and results.
CFR citation: 40 CFR 721.5725.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of phenol, 2,4dimethyl-6-(1-methylpentadecyl)-, EPA
preliminarily determined that one or
more of the criteria of concern
established at § 721.170 were met, as
discussed in Units II and IV.
B. Objectives
EPA is proposing this SNUR for a
chemical substance that has undergone
premanufacture review because the
Agency wants to achieve the following
objectives with regard to the significant
new uses designated in this proposed
rule:
• EPA would receive notice of any
person’s intent to manufacture, import,
or process a listed chemical substance
for the described significant new use
before that activity begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing a listed chemical substance
for the described significant new use.
• EPA would be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
substance before the described
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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.
VI. Notice and Comment Procedures
EPA is issuing this SNUR by notice
and comment procedure, as described in
§ 721.170(d)(4). In accordance with
§ 721.170(d)(4)(ii)(A), persons are given
the opportunity to submit comments on
or before January 27, 2012 on whether
EPA should establish notification
requirements.
VII. Applicability of the Proposed Rule
to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. EPA solicits comments on
whether any of the uses proposed as
significant new uses are ongoing.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule were considered ongoing rather
than new, it would be difficult for EPA
to establish SNUR notice requirements
because a person could defeat the SNUR
by initiating the significant new use
before the rule became final, and then
argue that the use was ongoing before
the effective date of the final rule. Thus,
persons who begin commercial
manufacture, import, or processing
activities with the chemical substances
that would be regulated as a ‘‘significant
new use’’ through this proposed rule,
must cease any such activity before the
effective date of the rule if and when
finalized. To resume their activities,
these persons would have to comply
with all applicable SNUR notice
requirements and wait until the notice
review period, including all extensions,
expires.
EPA has promulgated provisions to
allow persons to comply with this
proposed SNUR before the effective
date. If a person were to meet the
conditions of advance compliance
under § 721.45(h), the person would be
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considered exempt from the
requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. 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
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
EPA recommended certain testing in
Unit IV. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the OPPTS 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.
IX. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
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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 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.
X. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
subject to this proposed rule. EPA’s
complete economic analysis is available
in the docket under docket ID number
EPA–HQ–OPPT–2011–0633.
XI. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish a
SNUR for a chemical substance that was
the subject of a PMN. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA would amend the table
in 40 CFR part 9 to list the OMB
approval number for the information
collection requirements contained in
this proposed rule, if the SNUR is
subsequently issued as a 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.
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553(b)(3)(B), to amend this table without
further notice and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action would not impose any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
would not have a significant adverse
economic impact on a substantial
number of small entities. The rationale
supporting this conclusion is discussed
in this unit. The requirement to submit
a SNUN applies to any person
(including small or large entities) who
intends to engage in any activity
described in the rule as a ‘‘significant
new use.’’ Because these uses are
‘‘new,’’ based on all information
currently available to EPA, it appears
that no small or large entities presently
engage in such activities. A SNUR
requires that any person who intends to
engage in such activity in the future
must first notify EPA by submitting a
SNUN. Although some small entities
may decide to pursue a significant new
use in the future, EPA cannot presently
determine how many, if any, there may
be. However, EPA’s experience to date
is that, in response to the promulgation
of over 1,000 SNURs, the Agency
receives on average only 5 notices per
year. Of those SNUNs submitted from
2006–2008, only one appears to be from
a small entity. In addition, the estimated
reporting cost for submission of a SNUN
(see Unit IX.) is minimal regardless of
the size of the firm. Therefore, EPA
E:\FR\FM\28DEP1.SGM
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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules
believes that the potential economic
impacts of complying with this SNUR
are not expected to be significant or
adversely impact a substantial number
of small entities. In a SNUR that
published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL–5597–
1), the Agency presented its general
determination that final SNURs are not
expected to have a significant economic
impact on a substantial number of small
entities, which was provided to the
Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any 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).
mstockstill on DSK4VPTVN1PROD with PROPOSALS
E. Executive Order 13132
This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would not significantly nor
uniquely affect the communities of
Indian Tribal governments, nor would it
involve or impose any requirements that
affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
VerDate Mar<15>2010
17:25 Dec 27, 2011
Jkt 226001
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act
81441
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(2)(i) and (a)(3).
(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
(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. 2011–33256 Filed 12–27–11; 8:45 am]
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.
BILLING CODE 6560–50–P
J. Executive Order 12898
[EPA–HQ–OPPT–2010–1075; FRL–9329–4]
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).
RIN 2070–AB27
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR
part 721 be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. 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.
(2) The significant new uses are:
PO 00000
Frm 00041
Fmt 4702
Sfmt 4702
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
Proposed Significant New Use Rules
on Certain Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the chemical substances
rutile, tin zinc, calcium-doped (CAS No.
389623–01–2) and rutile, tin zinc,
sodium-doped (CAS No. 389623–07–8)
which were the subject of
premanufacture notices (PMNs P–06–36
and P–06–37) and TSCA section 5(e)
consent orders issued by EPA. The
proposed SNURs on these substances,
which are based on and consistent with
the provisions of the underlying consent
orders, would designate as a significant
new use the absence of the protective
measures required in the consent orders.
This action would require persons who
intend to manufacture, import, or
process either of the chemical
substances for an activity that is
designated as a significant new use by
this proposed rule to notify EPA at least
90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
the activity before it occurs.
DATES: Comments must be received on
or before January 27, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
SUMMARY:
E:\FR\FM\28DEP1.SGM
28DEP1
Agencies
[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81437-81441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33256]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0633; FRL-9325-9]
RIN 2070-AB27
Proposed Significant New Use Rule for Phenol, 2,4-dimethyl-6-(1-
methylpentadecyl)-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance identified as phenol, 2,4-dimethyl-6-(1-
methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5). This action
would require persons who intend to manufacture, import, or process the
substance for an activity that is designated as a significant new use
by this proposed rule to notify EPA at least 90 days before commencing
that activity. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs.
DATES: Comments must be received on or before January 27, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0633, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2011-0633. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0633. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For 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. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substance contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15
[[Page 81438]]
U.S.C. 2612) import certification requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. Importers of chemicals subject
to a final SNUR must certify their compliance with the SNUR
requirements. The EPA policy in support of import certification appears
at 40 CFR part 707, subpart B. In addition, any persons who export or
intend to export a chemical substance that is the subject of a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see Sec. [emsp14]721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
Under section 5(a)(2) of TSCA, EPA is re-proposing a SNUR
previously proposed for phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-
(PMN P-94-209; CAS No. 134701-20-5) in the Federal Register of
September 9, 1998 (63 FR 48157) (FRL-6020-8) but which was not
finalized. In the 1998 proposed SNUR, based on submitted test data, EPA
expressed concerns for liver toxicity, kidney toxicity, adrenal
toxicity, and blood toxicity. Additionally, based on submitted test
data and analogy to phenols, EPA was also concerned that toxicity to
aquatic organisms would occur at concentrations as low as 1 part per
billion (ppb). EPA determined that use of the substance as described in
the Premanufacture Notice (PMN) did not present an unreasonable risk
because workers would not be subject to significant dermal exposures
and there were no significant environmental releases. EPA also
determined that other potential uses of the substance may result in
significant dermal exposures to workers and significant environmental
releases. Based on this information, the PMN substance met the concern
criteria at Sec. 721.170 (b)(3)(i) and (b)(4)(i). In the 1998 proposed
SNUR, EPA proposed worker protection requirements as specified in Sec.
721.63 (a)(2)(i) and (a)(3), release to water restrictions as specified
in Sec. 721.90 (a)(1), (b)(1), and (c)(1) and associated recordkeeping
requirements.
Recently, EPA re-evaluated the information now available on phenol,
2,4-dimethyl-6-(1-methylpentadecyl)-. Since the PMN was initially
reviewed, the Agency's Ecological Structure Activity Relationships
(EcoSAR) dataset for phenols has been significantly updated to include
203 chemicals, up from 78 chemicals. The additional number of data
points has increased the robustness of the category, which has changed
the underlying Quantitative Structure Activity Relationships (QSAR). As
a result, when the most recent version of EcoSAR was run for phenol,
2,4-dimethyl-6-(1-methylpentadecyl)- in 2011, the program predicted no
adverse ecotoxicological effects at saturation for this substance.
Additionally, measured water solubility data submitted to the Agency
subsequent to the 1998 proposal support the new EcoSAR prediction of no
expected acute or chronic adverse ecological effects.
Therefore, based upon the new EcoSAR predictions and the measured
water solubility data, EPA now concludes that the ecological hazard and
risk of this substance are low. EPA no longer determines that this
substance may present an unreasonable risk to the aquatic environment.
As a result EPA, based on the new data received and the Agency's
predictive tools, no longer finds that the PMN substance meets the
concern criteria at Sec. 721.170 (b)(4)(i). Therefore, EPA is re-
proposing this SNUR, retaining the previously proposed worker
protection requirements specified in Sec. 721.63 (a)(2)(i) and (a)(3),
while removing the proposed release to water restrictions specified
Sec. 721.90 (a)(1), (b)(1), and (c)(1).
This proposed SNUR would require 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-methyl
pentadecyl)-, (PMN P-94-209; CAS No.134701-20-5), for any activity
preliminarily designated by this proposed 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. The record established for this proposed
SNUR is available in the docket under Docket ID number EPA-HQ-OPPT-
2011-0633.
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 rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to
[[Page 81439]]
Sec. [emsp14]721.1(c), persons subject to these SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, taking into consideration the four bulleted TSCA
section 5(a)(2) factors listed in this unit.
IV. Substance Subject to This Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for the chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)- (P-94-209). In this unit, EPA provides
the following information for this chemical substance:
PMN Number P-94-209
Chemical name: Phenol 2,4-dimethyl-6-(1-methylpentadecyl)-.
Chemical Abstracts Service (CAS) number: 134701-20-5.
Basis for action: The PMN states that the substance will be used as
an antioxidant. EPA is not aware of additional uses of this PMN
chemical substance. Based on submitted test data, there is concern for
liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity.
However, after review of the PMN EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because workers would not be subject to significant dermal exposures.
EPA has determined that other potential uses of the substance may
result in significant dermal exposures to workers. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(i).
Recommended testing: EPA has determined that a dermal absorption
study (OPPTS Test Guideline 870.3250) would help characterize the
health effects of the PMN substance. Test reports should include
protocols approved by the EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.5725.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, EPA
preliminarily determined that one or more of the criteria of concern
established at Sec. [emsp14]721.170 were met, as discussed in Units II
and IV.
B. Objectives
EPA is proposing this SNUR for a chemical substance that has
undergone premanufacture review because the Agency wants to achieve the
following objectives with regard to the significant new uses designated
in this proposed rule:
EPA would receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA would be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Notice and Comment Procedures
EPA is issuing this SNUR by notice and comment procedure, as
described in Sec. [emsp14]721.170(d)(4). In accordance with Sec.
[emsp14]721.170(d)(4)(ii)(A), persons are given the opportunity to
submit comments on or before January 27, 2012 on whether EPA should
establish notification requirements.
VII. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements because a
person could defeat the SNUR by initiating the significant new use
before the rule became final, and then argue that the use was ongoing
before the effective date of the final rule. Thus, persons who begin
commercial manufacture, import, or processing activities with the
chemical substances that would be regulated as a ``significant new
use'' through this proposed rule, must cease any such activity before
the effective date of the rule if and when finalized. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under Sec. 721.45(h), the person
would be
[[Page 81440]]
considered exempt from the requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. EPA recommended certain
testing in Unit IV. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OPPTS 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.
IX. 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 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.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this proposed rule. EPA's complete
economic analysis is available in the docket under docket ID number
EPA-HQ-OPPT-2011-0633.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish a SNUR for a chemical substance
that was the subject of a PMN. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA would amend the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed rule, if the SNUR is
subsequently issued as a 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
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is discussed in this unit. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the rule as a ``significant new
use.'' Because these uses are ``new,'' based on all information
currently available to EPA, it appears that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of over 1,000 SNURs, the
Agency receives on average only 5 notices per year. Of those SNUNs
submitted from 2006-2008, only one appears to be from a small entity.
In addition, the estimated reporting cost for submission of a SNUN (see
Unit IX.) is minimal regardless of the size of the firm. Therefore, EPA
[[Page 81441]]
believes that the potential economic impacts of complying with this
SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any 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 would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add Sec. 721.5725 to subpart E to read as follows:
Sec. 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.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(2)(i) and (a)(3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (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. 2011-33256 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P