Proposed Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-Dimethylpropyl Ester, 5761-5765 [2013-01589]
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[FR Doc. 2013–01656 Filed 1–25–13; 8:45 am]
BILLING CODE 3720–58–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2012–0864; FRL–9370–5]
RIN 2070–AB27
Proposed Modification of Significant
New Uses of Ethaneperoxoic Acid, 1,1Dimethylpropyl Ester
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Under the Toxic Substances
Control Act (TSCA), EPA is proposing to
amend the significant new use rule
(SNUR) for the chemical substance
identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, which was the
subject of premanufacture notice (PMN)
P–85–680. This action would amend the
SNUR to allow certain uses without
requiring a significant new use notice
(SNUN), and would extend SNUN
requirements to certain additional uses.
EPA is proposing this amendment based
on review of new toxicity test data.
DATES: Comments must be received on
or before February 27, 2013.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2012–0864, 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. ATTN: Docket ID
Number EPA–HQ–OPPT–2012–0864.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
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SUMMARY:
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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–
2012–0864. 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
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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: Jim
Alwood, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8974; email address:
alwood.jim@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.
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
identified as ethaneperoxoic acid, 1,1dimethylpropyl ester (PMN P–85–680).
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 manufacturers
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.
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
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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
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A. What action is the agency taking?
In the Federal Register of June 26,
1990 (55 FR 26102), EPA published a
final SNUR (codified at § 721.1560 and
redesignated as § 721.3020) for the
chemical substance identified as
ethaneperoxoic acid, 1,1dimethylpropyl ester (PMN P–85–680),
in accordance with the procedures at
§ 721.160. A SNUR requires persons
who intend to manufacture, import, or
process the chemical substance for an
activity designated as a significant new
use to notify EPA at least 90 days before
commencing that activity.
EPA is proposing to amend the scope
and requirements of the SNUR as
detailed in this unit. Because the
chemical identity of the chemical
substance is no longer confidential, EPA
is using the specific chemical name and
CAS number to identify the chemical
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substance. The docket established for
this proposed SNUR is available under
docket ID number EPA–HQ–OPPT–
2012–0864. The docket includes
information considered by the Agency
in developing the proposed rule and the
modified TSCA section 5(e) consent
order negotiated with the PMN
submitter.
PMN Number P–85–680
Chemical name: Ethaneperoxoic acid,
1,1-dimethylpropyl ester.
CAS number: 690–83–5
Effective date of the TSCA section 5(e)
consent order: January 30, 1986.
Federal Register publication date and
reference: June 26, 1990 (55 FR 26111).
Basis for modification of the SNUR:
The TSCA section 5(e) consent order
was issued under sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(II) based on the
finding that the chemical substance may
present an unreasonable risk of injury to
human health. To prevent any
unreasonable risk the order required
dermal and respiratory protection to
exposed workers, establishment of a
hazard communication program, limited
the specific use of the PMN substance
as described in the consent order, and
required disposal into a waste disposal
well. EPA subsequently modified the
consent order to allow disposal by
landfill and incineration. The proposed
SNUR for this chemical substance is
based on and consistent with the new
data and findings discussed in the two
paragraphs below. The proposed SNUR
designates as a ‘‘significant new use’’
any purposeful or predictable releases of
the PMN substance in concentrations
that exceed 61 parts per billion (ppb) in
surface waters.
Human health toxicity: EPA received
a petition from a second manufacturer
to revoke the SNUR based on toxicity
testing on structurally analogous
peroxide compounds, conducted after
the SNUR was issued. Based on the new
data EPA concurred with the finding
that the PMN substance did not present
a carcinogenicity hazard. EPA has also
changed its human health findings for
the TSCA new chemicals program
peroxide category (https://www.epa.gov/
oppt/newchems/pubs/
npcchemicalcategories.pdf).
Ecotoxicity concerns: Based on data
from ecotoxicity studies on structurally
analogous peroxy esters and neutral
organic chemicals, also conducted after
the SNUR was issued, EPA identified
potential environmental concerns if the
PMN substance was released to surface
waters. The second manufacturer also
conducted and submitted the results of
an acute algal study on the PMN
substance. Based on the submitted
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ecotoxicity testing for algae and
analogue data, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 61 ppb of the
PMN substance in surface waters.
The Agency concluded, after
examining the new human health
toxicity information, that its finding
under section 5(e)(1)(A)(ii)(I) of TSCA in
the original TSCA section 5(e) consent
order that certain activities involving
the substance may present an
unreasonable risk of injury to human
health is no longer supported. The
Agency also concluded based on the
ecotoxicity information, that the PMN
substance meets the concern criteria at
§ 721.170 (b)(4)(i) and (b)(4)(ii).
To conform with these findings, the
Agency is proposing the following
modifications to the SNUR:
1. Removing the significant new use
requirements for protective equipment,
hazard communication, and specific
uses identified in the consent order.
2. Modifying significant new use
requirements for environmental releases
by removing notification requirements
for disposal, and adding notification
requirements for water releases above 61
ppb.
3. Revising the recordkeeping
requirements to reflect the modified
SNUR requirements.
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075) and an aquatic invertebrate
acute toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.3020.
B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the TSCA section 5(a)(2)
factors, listed in Unit III. of this
document. Once EPA determines that a
use of a chemical substance is a
significant new use, TSCA section
5(a)(1)(B) and 40 CFR part 721 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.
EPA may respond to SNUNs by,
among other things, issuing or
modifying a TSCA section 5(e) consent
order and/or amending the SNUR
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promulgated under TSCA section
5(a)(2). Amendment of the SNUR will
often be necessary to allow persons
other than the SNUN submitter to
engage in the newly authorized use(s),
because even after a person submits a
SNUN and the review period expires,
other persons still must submit a SNUN
before engaging in the significant new
use. Procedures and criteria for
modifying or revoking SNUR
requirements appear at § 721.185.
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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 to human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance identified as ethaneperoxoic
acid, 1,1-dimethylpropyl ester (PMN P–
85–680), 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. Rationale for the Proposed Rule
During review of PMN P–85–680, the
chemical substance identified as
ethaneperoxoic acid, 1,1dimethylpropyl ester, EPA concluded
that regulation was warranted under
TSCA section 5(e), pending the
development of information sufficient to
make reasoned evaluations of the health
or environmental effects of this
chemical substance. The basis for such
findings is outlined in Unit II. of this
document and in the Federal Register
document of June 26, 1990 (55 FR
26102). Based on these findings, a TSCA
section 5(e) consent order requiring the
use of appropriate exposure controls
were negotiated with the PMN
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submitter. The SNUR provisions for this
chemical substance are consistent with
the provisions of the original TSCA
section 5(e) consent order. This SNUR
was promulgated pursuant to § 721.160.
After the review of new test data
subsequent to issuance of the TSCA
section 5(e) consent order for P–85–680
and associated SNUR (see Unit II.), and
consideration of the factors included in
TSCA section 5(a)(2) (see Unit III.), EPA
determined that the chemical substance
meets one or more of the concern
criteria in § 721.170(b), but that these
criteria are no longer met for the
personal protective equipment, hazard
communication, and specific use
notification requirements.
Consequently, EPA is proposing this
modification to the SNUR at § 721.3020
according to procedures in §§ 721.160
and 721.185.
V. Applicability of 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 section
5(a)(1)(B) of TSCA 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 as of the
effective date of the final rule.
Thus, any persons who begin
commercial manufacture, import, or
processing activities with the chemical
substances that are not currently a
significant new use under the current
rule but which would be regulated as a
‘‘significant new use’’ if this proposed
rule is finalized, must cease any such
activity as of 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
SNUR before the effective date. If a
person were to meet the conditions of
advance compliance under § 721.45(h),
the person would be considered to have
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met the requirements of the final SNUR
for those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require the development of any
particular test data before submission of
a SNUN. There are two exceptions:
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.
In this case, EPA recommends persons,
before performing any testing, to consult
with the Agency pertaining to protocol
selection. 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 modified TSCA section 5(e)
consent order for the chemical
substance that would be regulated under
this proposed rule does not require
submission of the test at any specified
time or volume. However, the
restrictions on manufacture, import,
processing, distribution in commerce,
use, and disposal of the PMN substance
would remain in effect until the consent
order is modified or revoked by EPA
based on submission of that or other
relevant information. These restricted
activities cannot be commenced unless
the PMN submitter first submits the
results of toxicity tests that would
permit a reasoned evaluation of the
potential risks posed by this chemical
substance. The test specified in the
modified TSCA section 5(e) consent
order is included in Unit II. The
proposed SNUR would contain the same
restrictions as the modified TSCA
section 5(e) consent order. Persons who
intend to commence non-exempt
commercial manufacture, import, or
processing for those activities proposed
as significant new uses would be
required to notify the Agency by
submitting a SNUN at least 90 days in
advance of commencement of those
activities.
The recommended testing specified in
Unit II. of this document may not be the
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only means of addressing the potential
risks of the chemical substance.
However, SNUNs submitted 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 substance.
• Potential benefits of the chemical
substance.
• Information on risks posed by the
chemical substance compared to risks
posed by potential substitutes.
VII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in
§ 720.50. SNUNs must be 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 evaluated the potential costs of
establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
during the development of the direct
final rule. The Agency’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2012–0864.
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IX. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would modify a
SNUR for a chemical substance that is
the subject of a PMN and TSCA section
5(e) consent order. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
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seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under the
PRA, unless it has been approved by
OMB and displays a currently valid
OMB control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA has amended the table
in 40 CFR part 9 to list the OMB
approval number for the information
collection requirements contained in
this proposed rule. This listing of the
OMB control numbers and their
subsequent codification in the CFR
satisfies the display requirements of
PRA and OMB’s implementing
regulations at 5 CFR part 1320. This
Information Collection Request (ICR)
was previously subject to public notice
and comment prior to OMB approval,
and given the technical nature of the
table, EPA finds that further notice and
comment to amend it is unnecessary.
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:
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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 proposed
rule.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the economic
analysis discussed in Unit VIII. and
EPA’s experience promulgating SNURs
(discussed in the certification), EPA
believes that the following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300. Therefore, the
promulgation of the SNUR would not
have a significant economic impact on
a substantial number of small entities.
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reason to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any 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
E:\FR\FM\28JAP1.SGM
28JAP1
Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Proposed Rules
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.
c. Remove paragraphs (a)(2)(iii) and
(a)(2)(iv).
■ d. Revise paragraph (b)(1).
■ e. Remove paragraph (b)(3).
The revisions read as follows:
■
§ 721.3020 Ethaneperoxoic acid, 1,1dimethylpropyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
ethaneperoxoic acid, 1,1dimethylpropyl ester (PMN P–85–680;
CAS No. 690–83–5) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=61).
(ii) [Reserved]
(b) * * *
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
*
*
*
*
*
[FR Doc. 2013–01589 Filed 1–25–13; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
J. Executive Order 12898
47 CFR Part 54
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 FR7629,
February 16, 1994).
[WC Docket Nos. 10–90 and 05–337; DA
12–1561, 12–1687, 12–2011, 12–2029, 13–70]
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: January 15, 2013.
Maria J. Doa,
Director, Chemical Control Division, 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:
tkelley on DSK3SPTVN1PROD with
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Amend § 721.3020 as follows:
a. Revise the section heading.
b. Revise paragraphs (a)(1), (a)(2)(i),
and (a)(2)(ii).
■
■
■
VerDate Mar<15>2010
16:17 Jan 25, 2013
Jkt 229001
Wireline Competition Bureau Releases
Connect America Phase II Cost Model
Virtual Workshop Discussion Topics
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Wireline Competition Bureau releases
for discussion a number of virtual
workshop topics related to the
development and adoption of the
forward-looking cost model for Connect
America Phase II.
DATES: Comments are due on or before
February 27, 2013 and reply comments
are due on or before March 14, 2013. If
you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: You may submit comments,
identified by WC Docket Nos. 10–90 and
05–337, by any of the following
methods:
SUMMARY:
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
5765
D Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
D Federal Communications
Commission’s Web Site: https://
fjallfoss.fcc.gov/ecfs2/. Follow the
instructions for submitting comments.
D Virtual Workshop: In addition to
the usual methods for filing electronic
comments, the Commission is allowing
comments, reply comments, and ex
parte comments in this proceeding to be
filed by posting comments at https://
www.fcc.gov/blog/wcb-cost-modelvirtual-workshop-2012.
D People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by email: FCC504@fcc.gov
or phone: (202) 418–0530 or TTY: (202)
418–0432.
For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Katie King, Wireline Competition
Bureau at (202) 418–7491 or TTY (202)
418–0484.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s Public
Notices in WC Docket Nos. 10–90, 05–
337; DA 12–1561, 12–1687, 12–2011,
12–2029, 13–70 released October 9,
2012, October 19, 2012, December 11,
2012, December 17, 2012, and January
17, 2013 as well as information posted
online in the Wireline Competition
Bureau’s Virtual Workshop. The
complete text of the Public Notices is
available for inspection and copying
during normal business hours in the
FCC Reference Information Center,
Portals II, 445 12th Street SW., Room
CY–A257, Washington, DC 20554.
These documents may also be
purchased from the Commission’s
duplicating contractor, Best Copy and
Printing, Inc. (BCPI), 445 12th Street
SW., Room CY–B402, Washington, DC
20554, telephone (800) 378–3160 or
(202) 863–2893, facsimile (202) 863–
2898, or via the Internet at https://
www.bcpiweb.com. In addition, the
Virtual Workshop may be accessed via
the Internet at https://www.fcc.gov/blog/
wcb-cost-model-virtual-workshop-2012.
I. Introduction
1. On November 18, 2011, the Federal
Communications Commission
(Commission) released the USF/ICC
Transformation Order, 76 FR 73829,
November 29, 2011, adopting a
framework for providing ongoing
support to areas served by price cap
E:\FR\FM\28JAP1.SGM
28JAP1
Agencies
[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Proposed Rules]
[Pages 5761-5765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01589]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2012-0864; FRL-9370-5]
RIN 2070-AB27
Proposed Modification of Significant New Uses of Ethaneperoxoic
Acid, 1,1-Dimethylpropyl Ester
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing to amend the significant new use rule (SNUR) for the chemical
substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester,
which was the subject of premanufacture notice (PMN) P-85-680. This
action would amend the SNUR to allow certain uses without requiring a
significant new use notice (SNUN), and would extend SNUN requirements
to certain additional uses. EPA is proposing this amendment based on
review of new toxicity test data.
DATES: Comments must be received on or before February 27, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0864, 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. ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0864. 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-
2012-0864. 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: Jim
Alwood, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8974; email address: alwood.jim@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 identified as
ethaneperoxoic acid, 1,1-dimethylpropyl ester (PMN P-85-680).
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
manufacturers 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.
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
[[Page 5762]]
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?
In the Federal Register of June 26, 1990 (55 FR 26102), EPA
published a final SNUR (codified at Sec. 721.1560 and redesignated as
Sec. 721.3020) for the chemical substance identified as ethaneperoxoic
acid, 1,1-dimethylpropyl ester (PMN P-85-680), in accordance with the
procedures at Sec. 721.160. A SNUR requires persons who intend to
manufacture, import, or process the chemical substance for an activity
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
EPA is proposing to amend the scope and requirements of the SNUR as
detailed in this unit. Because the chemical identity of the chemical
substance is no longer confidential, EPA is using the specific chemical
name and CAS number to identify the chemical substance. The docket
established for this proposed SNUR is available under docket ID number
EPA-HQ-OPPT-2012-0864. The docket includes information considered by
the Agency in developing the proposed rule and the modified TSCA
section 5(e) consent order negotiated with the PMN submitter.
PMN Number P-85-680
Chemical name: Ethaneperoxoic acid, 1,1-dimethylpropyl ester.
CAS number: 690-83-5
Effective date of the TSCA section 5(e) consent order: January 30,
1986.
Federal Register publication date and reference: June 26, 1990 (55
FR 26111).
Basis for modification of the SNUR: The TSCA section 5(e) consent
order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(II)
based on the finding that the chemical substance may present an
unreasonable risk of injury to human health. To prevent any
unreasonable risk the order required dermal and respiratory protection
to exposed workers, establishment of a hazard communication program,
limited the specific use of the PMN substance as described in the
consent order, and required disposal into a waste disposal well. EPA
subsequently modified the consent order to allow disposal by landfill
and incineration. The proposed SNUR for this chemical substance is
based on and consistent with the new data and findings discussed in the
two paragraphs below. The proposed SNUR designates as a ``significant
new use'' any purposeful or predictable releases of the PMN substance
in concentrations that exceed 61 parts per billion (ppb) in surface
waters.
Human health toxicity: EPA received a petition from a second
manufacturer to revoke the SNUR based on toxicity testing on
structurally analogous peroxide compounds, conducted after the SNUR was
issued. Based on the new data EPA concurred with the finding that the
PMN substance did not present a carcinogenicity hazard. EPA has also
changed its human health findings for the TSCA new chemicals program
peroxide category (https://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf).
Ecotoxicity concerns: Based on data from ecotoxicity studies on
structurally analogous peroxy esters and neutral organic chemicals,
also conducted after the SNUR was issued, EPA identified potential
environmental concerns if the PMN substance was released to surface
waters. The second manufacturer also conducted and submitted the
results of an acute algal study on the PMN substance. Based on the
submitted ecotoxicity testing for algae and analogue data, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
61 ppb of the PMN substance in surface waters.
The Agency concluded, after examining the new human health toxicity
information, that its finding under section 5(e)(1)(A)(ii)(I) of TSCA
in the original TSCA section 5(e) consent order that certain activities
involving the substance may present an unreasonable risk of injury to
human health is no longer supported. The Agency also concluded based on
the ecotoxicity information, that the PMN substance meets the concern
criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
To conform with these findings, the Agency is proposing the
following modifications to the SNUR:
1. Removing the significant new use requirements for protective
equipment, hazard communication, and specific uses identified in the
consent order.
2. Modifying significant new use requirements for environmental
releases by removing notification requirements for disposal, and adding
notification requirements for water releases above 61 ppb.
3. Revising the recordkeeping requirements to reflect the modified
SNUR requirements.
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) and an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.3020.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the TSCA section 5(a)(2) factors, listed in
Unit III. of this document. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
and 40 CFR part 721 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. [emsp14]721.5.
EPA may respond to SNUNs by, among other things, issuing or
modifying a TSCA section 5(e) consent order and/or amending the SNUR
[[Page 5763]]
promulgated under TSCA section 5(a)(2). Amendment of the SNUR will
often be necessary to allow persons other than the SNUN submitter to
engage in the newly authorized use(s), because even after a person
submits a SNUN and the review period expires, other persons still must
submit a SNUN before engaging in the significant new use. Procedures
and criteria for modifying or revoking SNUR requirements appear at
Sec. 721.185.
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 to human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester (PMN P-85-680), 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. Rationale for the Proposed Rule
During review of PMN P-85-680, the chemical substance identified as
ethaneperoxoic acid, 1,1-dimethylpropyl ester, EPA concluded that
regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health or environmental effects of this chemical substance. The
basis for such findings is outlined in Unit II. of this document and in
the Federal Register document of June 26, 1990 (55 FR 26102). Based on
these findings, a TSCA section 5(e) consent order requiring the use of
appropriate exposure controls were negotiated with the PMN submitter.
The SNUR provisions for this chemical substance are consistent with the
provisions of the original TSCA section 5(e) consent order. This SNUR
was promulgated pursuant to Sec. [emsp14]721.160.
After the review of new test data subsequent to issuance of the
TSCA section 5(e) consent order for P-85-680 and associated SNUR (see
Unit II.), and consideration of the factors included in TSCA section
5(a)(2) (see Unit III.), EPA determined that the chemical substance
meets one or more of the concern criteria in Sec. 721.170(b), but that
these criteria are no longer met for the personal protective equipment,
hazard communication, and specific use notification requirements.
Consequently, EPA is proposing this modification to the SNUR at Sec.
721.3020 according to procedures in Sec. Sec. 721.160 and 721.185.
V. Applicability of 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 section 5(a)(1)(B) of TSCA 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 as of the effective date of the
final rule.
Thus, any persons who begin commercial manufacture, import, or
processing activities with the chemical substances that are not
currently a significant new use under the current rule but which would
be regulated as a ``significant new use'' if this proposed rule is
finalized, must cease any such activity as of 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
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. [emsp14]721.45(h), the person would
be considered to have met the requirements of the final SNUR for those
activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. There are two
exceptions:
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. In this case, EPA recommends
persons, before performing any testing, to consult with the Agency
pertaining to protocol selection. 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 modified TSCA section 5(e) consent order for the chemical
substance that would be regulated under this proposed rule does not
require submission of the test at any specified time or volume.
However, the restrictions on manufacture, import, processing,
distribution in commerce, use, and disposal of the PMN substance would
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information. These
restricted activities cannot be commenced unless the PMN submitter
first submits the results of toxicity tests that would permit a
reasoned evaluation of the potential risks posed by this chemical
substance. The test specified in the modified TSCA section 5(e) consent
order is included in Unit II. The proposed SNUR would contain the same
restrictions as the modified TSCA section 5(e) consent order. Persons
who intend to commence non-exempt commercial manufacture, import, or
processing for those activities proposed as significant new uses would
be required to notify the Agency by submitting a SNUN at least 90 days
in advance of commencement of those activities.
The recommended testing specified in Unit II. of this document may
not be the
[[Page 5764]]
only means of addressing the potential risks of the chemical substance.
However, SNUNs submitted 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 substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
VII. SNUN Submissions
According to 40 CFR 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
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.
[emsp14]721.25 and 720.40. E-PMN software is available electronically
at https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA evaluated the potential costs of establishing SNUN requirements
for potential manufacturers, importers, and processors of the chemical
substances during the development of the direct final rule. The
Agency's complete economic analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2012-0864.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would modify a SNUR for a chemical substance
that is the subject of a PMN and TSCA section 5(e) consent order. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA has amended the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed rule. This listing
of the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320. This Information Collection Request
(ICR) was previously subject to public notice and comment prior to OMB
approval, and given the technical nature of the table, EPA finds that
further notice and comment to amend it is unnecessary.
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
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the economic analysis discussed in Unit VIII.
and EPA's experience promulgating SNURs (discussed in the
certification), EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any 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
[[Page 5765]]
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 FR7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 15, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Amend Sec. [emsp14]721.3020 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a)(1), (a)(2)(i), and (a)(2)(ii).
0
c. Remove paragraphs (a)(2)(iii) and (a)(2)(iv).
0
d. Revise paragraph (b)(1).
0
e. Remove paragraph (b)(3).
The revisions read as follows:
Sec. 721.3020 Ethaneperoxoic acid, 1,1-dimethylpropyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethaneperoxoic
acid, 1,1-dimethylpropyl ester (PMN P-85-680; CAS No. 690-83-5) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) * * *
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=61).
(ii) [Reserved]
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
* * * * *
[FR Doc. 2013-01589 Filed 1-25-13; 8:45 am]
BILLING CODE 6560-50-P