Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-Dimethylpropyl Ester, 46283-46287 [2013-18180]
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46283
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
submitted under FFDCA section 408(d),
such as the tolerance in this final rule,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 22, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.569, revise paragraphs
(a)(1) introductory text and (a)(2) to read
as follows:
■
§ 180.569 Forchlorfenuron; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of
forchlorfenuron, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea).
*
*
*
*
*
(2) Temporary tolerances are
established for residues of
forchlorfenuron, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring on forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea).
Parts per
million
Commodity
Almond .....................................................................................................................................................................
Almond, hulls ...........................................................................................................................................................
Cherry, sweet ...........................................................................................................................................................
Fig ............................................................................................................................................................................
Pear .........................................................................................................................................................................
Pistachio ..................................................................................................................................................................
Plum, prune, fresh ...................................................................................................................................................
*
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[FR Doc. 2013–18182 Filed 7–30–13; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
BILLING CODE 6560–50–P
40 CFR Part 721
[EPA–HQ–OPPT–2012–0864; FRL–9392–4]
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RIN 2070–AB27
Modification of Significant New Uses
of Ethaneperoxoic Acid, 1,1Dimethylpropyl Ester
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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Under the Toxic Substances
Control Act (TSCA), EPA is finalizing an
amendment to 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 requires persons
who intend to manufacture or process
the chemical substance for a use that is
designated as a significant new use by
this final rule to notify EPA at least 90
days before commencing that activity.
EPA believes that this action is
necessary because new uses of the
SUMMARY:
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chemical substance may be hazardous to
human health. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
that activity before it occurs.
DATES: This final rule is effective August
30, 2013.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2012–0864, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Please review the visitor
instructions and additional information
about the docket available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: 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. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, 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 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
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you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127, and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a SNUR must
certify their compliance with the SNUR
requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export the chemical substance
that is the subject of a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b)(15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
II. Background
A. What action is the agency taking?
EPA is finalizing an amendment to
the SNUR for the chemical substance
identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680),
codified at 40 CFR 721.3020. This final
action requires persons who intend to
manufacture or process the chemical
substance for an activity that is
designated as a significant new use by
this final rule to notify EPA at least 90
days before commencing that activity.
This rule was proposed in the Federal
Register issue of January 28, 2013 (78
FR 5761) (FRL–9370–5). EPA received
no public comments in response to the
proposal. Therefore, the Agency is
issuing a final SNUR, as proposed that:
1. Removes the significant new use
requirements for protective equipment,
hazard communication, and specific
uses identified in the consent order.
2. Modifies significant new use
requirements for environmental releases
by removing notification requirements
for disposal and adding notification
requirements for water releases above 61
parts per billion (ppb).
3. Revises the recordkeeping
requirements to reflect the modified
SNUR requirements.
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B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors, listed in Unit IV.
of this document. Once EPA determines
that a use of a chemical substance is a
significant new use, TSCA section
5(a)(1)(B) requires persons to submit a
significant new use notice (SNUN) to
EPA at least 90 days before they
manufacture or process the chemical
substance for that use. Persons who
must report are described in § 721.5.
III. Rationale for the 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 the
proposed rule to amend this SNUR,
included in the Federal Register issue
of January 28, 2013 (78 FR 5761)
(‘‘proposed amended rule’’), and in the
original final rule 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 hazard communication and
appropriate exposure, use, and disposal
controls was negotiated with the PMN
submitter. The SNUR provisions for this
chemical substance were consistent
with the provisions of the original TSCA
section 5(e) consent order. The SNUR
was promulgated pursuant to § 721.160,
and codified at § 721.1560 and
redesignated as § 721.3020.
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. of the
proposed amended rule), and
consideration of the factors included in
TSCA section 5(a)(2) (see Unit IV.), 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.
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IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute 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, 1,1dimethylpropyl 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.
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V. Applicability of the Significant New
Use Designation
If uses begun after the proposed rule
was published were considered ongoing
rather than new, any person could
defeat the SNUR by initiating the
significant new use before the final rule
was issued. Therefore, EPA has
designated the date of publication of the
proposed rule as the cutoff date for
determining whether the new use is
ongoing. Consult the Federal Register
document of April 24, 1990 (55 FR
17376) for a more detailed discussion of
the cutoff date for ongoing uses.
Any person who began commercial
manufacture or processing of the
chemical substance identified as
ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680),
for any of the significant new uses
designated in the proposed SNUR
modification after the date of
publication of the proposed SNUR, must
stop that activity before the effective
date of the final rule. Persons who
ceased those activities will have to first
comply with all applicable SNUR
notification requirements and wait until
the notice review period, including any
extensions, expires, before engaging in
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any activities designated as significant
new uses. If a person were to meet the
conditions of advance compliance
under § 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
§ 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.
The recommended testing specified in
Unit II.A. of the proposed rule may not
be the 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 substances.
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VII. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
regulatory procedures as persons
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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 and processors
of the chemical substance during the
development of the direct final rule. The
Agency’s complete Economic Analysis
is available in the docket under docket
ID number EPA–HQ–OPPT–2012–0864.
IX. Statutory and Executive Order
Reviews
A. Executive Order 12866
This action modifies 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 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 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.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
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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.
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C. Regulatory Flexibility Act
On February 18, 2012, EPA certified
pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), that promulgation of
a SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this rule.
This rule is within the scope of the
February 18, 2012 certification. Based
on the Economic Analysis discussed in
Unit VIII. and EPA’s experience
promulgating SNURs (discussed in the
certification), EPA believes that the
following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300. Therefore, the
promulgation of the SNUR would not
have a significant economic impact on
a substantial number of small entities.
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
final rule. As such, EPA has determined
that this final rule does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any affect
on small governments subject to the
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requirements of sections 202, 203, 204,
or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
E. Executive Order 13132
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This final rule does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This final rule does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
With Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply
to this final rule.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: July 16, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, 40 CFR part 721 is
amended as follows:
G. Executive Order 13045
PART 721—[AMENDED]
This action is not subject to Executive
Order 13045, entitled Protection of
Children From Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
■
H. Executive Order 13211
This action is not subject to Executive
Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
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1. The authority citation for part 721
continues to read as follows:
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) and
(a)(2)(i).
■ c. Remove and reserve paragraph
(a)(2)(ii) and remove paragraphs
(a)(2)(iii) and (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
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§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
*
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[FR Doc. 2013–18180 Filed 7–30–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
48 CFR Parts 1504, 1509, 1511, 1516,
1522, 1523, 1528, and 1552
[EPA–HQ–OARM–2013–0294 FRL 9837–4]
Administrative Revisions to EPAAR
Environmental Protection
Agency.
ACTION: Direct final rule.
AGENCY:
The EPA is taking direct final
action on administrative changes to the
EPA Acquisition Regulation (EPAAR).
This action revises the EPAAR, but does
not impose any new requirements on
Agency contractors. The revisions in
this direct final rule will make minor
corrections to and streamline Agency
acquisition processes to be consistent
with and non-duplicative of the Federal
Acquisition Regulation (FAR). EPA is
issuing a final rule because the changes
are administrative in nature and does
not anticipate receiving adverse
comments.
SUMMARY:
This rule is effective September
30, 2013 without further action, unless
adverse comment is received by August
30, 2013. If adverse comment is
received, the EPA will publish a timely
withdrawal of the rule in the Federal
Register.
DATES:
Submit your comments,
identified by Docket ID No. EPA–HQ–
OARM–2013–0294, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• Email: docket.oei@epa.gov.
• Fax: (202) 566–1753.
• Mail: EPA–HQ–OARM–2013–0294,
OEI Docket, Environmental Protection
Agency, 2822T, 1200 Pennsylvania Ave.
NW., Washington, DC 20460. Please
include a total of three (3) copies.
• Hand Delivery: EPA Docket CenterAttention OEI Docket, EPA West, Room
B102, 1301 Constitution Ave. NW.,
Washington, DC 20004. Such deliveries
are only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OARM–2013–
0294. EPA’s policy is that all comments
ehiers on DSK2VPTVN1PROD with RULES
ADDRESSES:
VerDate Mar<15>2010
17:54 Jul 30, 2013
Jkt 229001
received will be included in the public
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 https://
www.regulations.gov or email. The
https://www.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
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public 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. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. 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 either
electronically in https://
www.regulations.gov Federal Register,
or in hard copy at the Government
Property-Contract Property
Administration Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the EPA Docket Center is
(202) 566–1752. This Docket Facility is
open from 8:30 a.m. to 4:30 p.m.,
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
46287
Monday through Friday, excluding legal
holidays.
FOR FURTHER INFORMATION CONTACT:
Daniel Humphries, Policy, Training and
Oversight Division, Office of
Acquisition Management (3802R),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460; telephone number: 202–564–
4377; email address:
humphries.daniel@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
1. Submitting Classified Business
Information (CBI). Do not submit this
information to EPA through https://
www.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:
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
• 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.
• Explain why you agree or disagree,
suggest alternatives, and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
• Make sure to submit your
comments by the comment period
deadline identified.
E:\FR\FM\31JYR1.SGM
31JYR1
Agencies
[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46283-46287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18180]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2012-0864; FRL-9392-4]
RIN 2070-AB27
Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-
Dimethylpropyl Ester
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
finalizing an amendment to 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 requires persons who intend to manufacture
or process the chemical substance for a use that is designated as a
significant new use by this final rule to notify EPA at least 90 days
before commencing that activity. EPA believes that this action is
necessary because new uses of the
[[Page 46284]]
chemical substance may be hazardous to human health. The required
notification would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it occurs.
DATES: This final rule is effective August 30, 2013.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2012-0864, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact: 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. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
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 or processors of the subject chemical substance
(NAICS codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127,
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to a SNUR must certify their
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export the chemical
substance that is the subject of a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b)(15 U.S.C.
2611(b)) (see Sec. 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
II. Background
A. What action is the agency taking?
EPA is finalizing an amendment to the SNUR for the chemical
substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester,
(PMN P-85-680), codified at 40 CFR 721.3020. This final action requires
persons who intend to manufacture or process the chemical substance for
an activity that is designated as a significant new use by this final
rule to notify EPA at least 90 days before commencing that activity.
This rule was proposed in the Federal Register issue of January 28,
2013 (78 FR 5761) (FRL-9370-5). EPA received no public comments in
response to the proposal. Therefore, the Agency is issuing a final
SNUR, as proposed that:
1. Removes the significant new use requirements for protective
equipment, hazard communication, and specific uses identified in the
consent order.
2. Modifies significant new use requirements for environmental
releases by removing notification requirements for disposal and adding
notification requirements for water releases above 61 parts per billion
(ppb).
3. Revises the recordkeeping requirements to reflect the modified
SNUR requirements.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors, listed in Unit IV. of this document. Once EPA determines that
a use of a chemical substance is a significant new use, TSCA section
5(a)(1)(B) requires persons to submit a significant new use notice
(SNUN) to EPA at least 90 days before they manufacture or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
III. Rationale for the 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 the proposed rule to
amend this SNUR, included in the Federal Register issue of January 28,
2013 (78 FR 5761) (``proposed amended rule''), and in the original
final rule 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 hazard communication and appropriate exposure, use, and
disposal controls was negotiated with the PMN submitter. The SNUR
provisions for this chemical substance were consistent with the
provisions of the original TSCA section 5(e) consent order. The SNUR
was promulgated pursuant to Sec. 721.160, and codified at Sec.
721.1560 and redesignated as Sec. 721.3020.
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. of the proposed amended rule), and consideration of the
factors included in TSCA section 5(a)(2) (see Unit IV.), 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.
[[Page 46285]]
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute 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.
V. Applicability of the Significant New Use Designation
If uses begun after the proposed rule was published were considered
ongoing rather than new, any person could defeat the SNUR by initiating
the significant new use before the final rule was issued. Therefore,
EPA has designated the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing. Consult the
Federal Register document of April 24, 1990 (55 FR 17376) for a more
detailed discussion of the cutoff date for ongoing uses.
Any person who began commercial manufacture or processing of the
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester, (PMN P-85-680), for any of the significant new
uses designated in the proposed SNUR modification after the date of
publication of the proposed SNUR, must stop that activity before the
effective date of the final rule. Persons who ceased those activities
will have to first comply with all applicable SNUR notification
requirements and wait until the notice review period, including any
extensions, expires, before engaging in any activities designated as
significant new uses. If a person were to meet the conditions of
advance compliance under 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.
The recommended testing specified in Unit II.A. of the proposed
rule may not be the 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 substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VII. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same 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.
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 and processors of the chemical substance
during the development of the direct final rule. The Agency's complete
Economic Analysis is available in the docket under docket ID number
EPA-HQ-OPPT-2012-0864.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
This action modifies 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 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 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.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated
[[Page 46286]]
to average between 30 and 170 hours per response. This burden estimate
includes the time needed to review instructions, search existing data
sources, gather and maintain the data needed, and complete, review, and
submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that
promulgation of a SNUR does not have a significant economic impact on a
substantial number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
rule.
This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit VIII.
and EPA's experience promulgating SNURs (discussed in the
certification), EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this final rule.
As such, EPA has determined that this final rule does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This final rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule does not significantly nor uniquely affect the communities
of Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled Consultation and Coordination With
Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply
to this final rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
Protection of Children From Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use and
because this action is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 16, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is 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. 721.3020 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a)(1) and (a)(2)(i).
0
c. Remove and reserve paragraph (a)(2)(ii) and remove paragraphs
(a)(2)(iii) and (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
[[Page 46287]]
Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
* * * * *
[FR Doc. 2013-18180 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P