Proposed Significant New Use Rule on Ethoxylated, Propoxylated Diamine Diaryl Substituted Phenylmethane Ester With Alkenylsuccinate, Dialkylethanolamine Salt, 75085-75089 [2012-30355]
Download as PDF
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules
exemption from the requirement of a
tolerance for residues of trans-1-chloro3,3,3-trifluoropropene (CAS No.
102687–65–0) under §§ 180.910,
180.930, and 180.940 when used as a
pesticide inert ingredient (propellant) in
pesticide formulations. No analytical
method is included as this is a petition
for exemption from the requirements of
a tolerance. Contact: Lisa Austin, (703)
305–7894, email address:
austin.lisa@epa.gov.
2. PP 2E8082. (EPA–HQ–OPP–2012–
0789). Sekisui Specialty Chemicals,
1501 West, LBJ Freeway, Dallas, TX
75234, requests to establish an
exemption from the requirement of a
tolerance for residues of 2-pyrrolidone,
1-ethenyl-, polymer with ethenol (CAS
No. 26008–54–8) under § 180.960 when
used as a pesticide inert ingredient in
pesticide formulations for a packaging
film for unit dose packaging of
pesticides and pool sanitizers. The
petitioner believes no analytical method
is needed because it is not required for
the establishment of a tolerance
exemption for inert ingredients. Contact:
David Lieu, (703) 305–0079, email
address: lieu.david@epa.gov.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 11, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. 2012–30450 Filed 12–18–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2011–0577; FRL–9370–1]
RIN 2070–AB27
Proposed Significant New Use Rule on
Ethoxylated, Propoxylated Diamine
Diaryl Substituted Phenylmethane
Ester With Alkenylsuccinate,
Dialkylethanolamine Salt
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
wreier-aviles on DSK5TPTVN1PROD with
AGENCY:
EPA is proposing a significant
new use rule (SNUR) under the Toxic
Substances Control Act (TSCA) for the
chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
SUMMARY:
VerDate Mar<15>2010
15:12 Dec 18, 2012
Jkt 229001
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt, which was the subject of
premanufacture notice (PMN) P–01–
384. This action would require persons
who intend to manufacture, import, or
process this chemical substance for an
activity that is designated as a
significant new use by this proposed
rule to notify EPA at least 90 days before
commencing that activity. The required
notification would provide EPA with
the opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
the activity before it occurs.
DATES: Comments must be received on
or before January 18, 2013.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2011–0577, 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–2011–0577.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2011–0577. 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
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
75085
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:
Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (202) 564–9232;
email address: moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave. Rochester, NY
14620; telephone number: (202) 554–
1404; email address: 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
E:\FR\FM\19DEP1.SGM
19DEP1
75086
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules
wreier-aviles on DSK5TPTVN1PROD with
generically identified as ethoxylated,
propoxylated diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt (generic). Potentially affected
entities may include:
• Manufacturers, importers, or
processors of the subject chemical
substance (NAICS codes 325 and
324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a final SNUR
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of a proposed or final
SNUR, are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
VerDate Mar<15>2010
15:12 Dec 18, 2012
Jkt 229001
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?
EPA is proposing a SNUR under
section 5(a)(2) of TSCA for the chemical
substance identified generically as
ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester
with alkenylsuccinate,
dialkylethanolamine salt, which was the
subject of PMN P–01–384. This SNUR
would require persons who intend to
manufacture, import, or process the
chemical substance for an activity that
is designated as a significant new use to
notify EPA at least 90 days before
commencing that activity.
In the Federal Register of April 27,
2012 (77 FR 23236) (FRL–9343–4), EPA
issued a direct final rule which
established a SNUR for ethoxylated,
propoxylated diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt (generic) in accordance with the
procedures at 40 CFR 721.160(c)(3)(i).
EPA received notice of intent to submit
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
adverse comments on this SNUR.
Therefore, as required by
§ 721.160(c)(3)(ii), EPA withdrew the
direct final SNUR in the Federal
Register of July 25, 2012 (77 FR 43520)
(FRL–9356–1), and is now issuing this
proposed rule on the chemical
substance. The record for the direct final
SNUR on this substance was established
as docket EPA–HQ–OPPT–2011–0577.
That record includes information
considered by the Agency in developing
the direct final rule and the notice of
intent to submit adverse comments.
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 III.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture, import, or
process the chemical substance for that
use. Persons who must report are
described in § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
§ 721.1(c), persons subject to this SNUR
must comply with the same notice
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the
regulations at 40 CFR part 720. Once
EPA receives a SNUN, EPA may take
regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities
for which it has received the SNUN. If
EPA does not take action, EPA is
required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
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
E:\FR\FM\19DEP1.SGM
19DEP1
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorized EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance that is the subject of this
proposed SNUR, EPA considered
relevant information about the toxicity
of the chemical substance, likely human
exposures and environmental releases
associated with possible uses, and the
four bulleted TSCA section 5(a)(2)
factors listed in this unit.
wreier-aviles on DSK5TPTVN1PROD with
IV. Substance Subject to This Proposed
Rule
This proposed SNUR is for a PMN
substance which EPA did not find that
the use scenario described in the PMN
triggered the determinations set forth
under TSCA section 5(e). However, EPA
does believe that certain changes from
the use scenario described in the PMN
could result in increased exposures,
thereby constituting a ‘‘significant new
use.’’ These so-called ‘‘non-section 5(e)
SNURs’’ are promulgated pursuant to
§ 721.170. EPA has determined that
every activity designated as a
‘‘significant new use’’ in all non-section
5(e) SNURs issued under § 721.170
satisfies the two requirements stipulated
in § 721.170(c)(2), i.e., these significant
new use activities, ‘‘(i) are different from
those described in the premanufacture
notice for the substance, including any
amendments, deletions, and additions
of activities to the premanufacture
notice, and (ii) may be accompanied by
changes in exposure or release levels
that are significant in relation to the
health or environmental concerns
identified’’ for the PMN substance.
PMN Number P–01–384
Chemical name: Ethoxylated,
propoxylated diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt (generic).
CAS number: Not available.
VerDate Mar<15>2010
15:12 Dec 18, 2012
Jkt 229001
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a colorant for
aqueous ink applications. Based on
ecological structure activity relationship
(EcoSAR) analysis of test data on
analogous amphoteric dyes, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
70 parts per billion (ppb) of the PMN
substance in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substance to surface water exceed
releases from the use described in the
PMN. For the use described in the PMN,
environmental releases did not exceed
70 ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than as described in
the PMN, or any release of a
manufacturing waste stream containing
the PMN substance into the waters of
the United States without prior
chemical destruction or conversion,
may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10308.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMN submitted
for the chemical substance generically
identified as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt, EPA determined that one or more
of the criteria of concern established at
§ 721.170 were met, as discussed in Unit
IV.
Based upon comments received on
the direct final rule, the proposed SNUR
for 40 CFR 721.10308, includes the
following changes:
1. Redesignation of paragraph (a)(2)(i)
as (a)(2)(ii).
PO 00000
Frm 00023
Fmt 4702
Sfmt 4702
75087
2. Revision of the new paragraph
(a)(2)(ii).
3. Addition of new paragraph (a)(2)(i).
B. Objectives
EPA is proposing this SNUR for
ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester
with alkenylsuccinate,
dialkylethanolamine salt, which has
undergone PMN review, because the
Agency wants to achieve the following
objectives with regard to the significant
new uses designated in this proposed
rule:
• EPA would receive notice of any
person’s intent to manufacture, import,
or process this chemical substance for
the described significant new use before
that activity begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing this chemical substance for
the described significant new use.
• EPA would be able to regulate
prospective manufacturers, importers,
or processors of this chemical substance
before the described significant new use
of that chemical substance occurs,
provided that regulation is warranted
pursuant to TSCA sections 5(e), 5(f), 6,
or 7.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Inventory. Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
Internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
VI. Applicability of the Proposed Rule
to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. The chemical substance
subject to this proposed rule has
undergone premanufacture review. EPA
is soliciting comments on whether any
of the uses proposed as significant new
uses are ongoing.
As discussed in the final SNUR rule
published in the Federal Register issue
of April 24, 1990, (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
previous direct final rule rather than as
of the effective date of this final rule. If
uses begun after publication of the
direct final were considered ongoing
rather than new, it would be difficult for
EPA to establish SNUR notice
requirements because a person could
E:\FR\FM\19DEP1.SGM
19DEP1
75088
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules
wreier-aviles on DSK5TPTVN1PROD with
defeat the SNUR by initiating the
significant new use before this final rule
became effective, and then argue that
the use was ongoing before the effective
date of the rule. Thus, persons who
begin commercial manufacture, import,
or processing of the chemical substances
regulated through this SNUR will have
to cease any such activity before the
effective date of this rule. To resume
their activities, these persons would
have to comply with all applicable
SNUR notice requirements and wait
until the notice review period,
including any extensions, expires.
EPA has promulgated provisions to
allow persons to comply with this
SNUR before the effective date. If a
person meets the conditions of advance
compliance under § 721.45(h), the
person is considered exempt from the
requirements of the SNUR.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
In cases where EPA issued a TSCA
section 5(e) consent order that requires
or recommends certain testing, Unit IV.
would list those tests. Descriptions of
tests are provided for informational
purposes. EPA strongly encourages
persons, before performing any testing,
to consult with the Agency pertaining to
protocol selection. To access the OCSPP
test guidelines referenced in this
document electronically, please go to
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
VerDate Mar<15>2010
15:12 Dec 18, 2012
Jkt 229001
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.
VIII. SNUN Submissions
According to § 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 submitted on
EPA Form No. 7710–25, generated using
e-PMN software, and submitted to the
Agency in accordance with the
procedures set forth in §§ 721.25 and
720.40. E–PMN software is available
electronically at https://www.epa.gov/
opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substance
during the development of the direct
final rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2011–0577.
X. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish a
SNUR for one chemical substance that
was the subject of a PMN. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
PO 00000
Frm 00024
Fmt 4702
Sfmt 4702
numbers for EPA’s regulations in Title
40 of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this 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. As a result, EPA finds
that there is ‘‘good cause’’ under section
553(b)(3)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), to
amend this table without further notice
and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action would not impose any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (5 U.S.C.
601 et seq.), that promulgation of a
SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
E:\FR\FM\19DEP1.SGM
19DEP1
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules
2. The SNUR submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this proposed
rule.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the Economic
Analysis discussed in Unit IX. and
EPA’s experience promulgating SNURs
(discussed in the certification), EPA
believes that the following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule when promulgated as
final. As such, EPA has determined that
this proposed rule, when promulgated
as final, 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).
wreier-aviles on DSK5TPTVN1PROD with
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
VerDate Mar<15>2010
15:12 Dec 18, 2012
Jkt 229001
75089
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
§ 721.10308 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate,
dialkylethanolamine salt (generic).
G. Executive Order 13045
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt (PMN P–01–384) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) Release to water. Requirements as
specified in § 721.90(a)(2)(v).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i), and (k) are
applicable to manufacturers, importers,
and processors of the substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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
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, (15 U.S.C. 272
note), does not apply to this action.
[FR Doc. 2012–30355 Filed 12–18–12; 8:45 am]
BILLING CODE 6560–50–P
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).
DEPARTMENT OF DEFENSE
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
[FAR Case 2012–031; Docket 2012–0031,
Sequence 1]
RIN 9000–AM37
Dated: December 10, 2012.
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:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10308 to subpart E to
read as follows:
PO 00000
Frm 00025
Fmt 4702
Sfmt 4702
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 12, 32, and 52
Federal Acquisition Regulation;
Accelerated Payments to Small
Business Subcontractors
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Proposed rule.
AGENCIES:
DoD, GSA, and NASA are
proposing to amend the Federal
Acquisition Regulation (FAR) to
implement the temporary policy
provided by Office of Management and
Budget (OMB) Policy Memorandum M–
12–16, dated July 11, 2012, by adding a
SUMMARY:
E:\FR\FM\19DEP1.SGM
19DEP1
Agencies
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Proposed Rules]
[Pages 75085-75089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30355]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0577; FRL-9370-1]
RIN 2070-AB27
Proposed Significant New Use Rule on Ethoxylated, Propoxylated
Diamine Diaryl Substituted Phenylmethane Ester With Alkenylsuccinate,
Dialkylethanolamine Salt
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under the
Toxic Substances Control Act (TSCA) for the chemical substance
identified generically as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which was the subject of premanufacture
notice (PMN) P-01-384. This action would require persons who intend to
manufacture, import, or process this chemical substance for an activity
that is designated as a significant new use by this proposed rule to
notify EPA at least 90 days before commencing that activity. The
required notification would provide EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit the
activity before it occurs.
DATES: Comments must be received on or before January 18, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0577, 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-2011-0577. The DCO is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0577. 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: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. 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
[[Page 75086]]
generically identified as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt (generic). Potentially affected entities may
include:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemicals subject to a final SNUR
must certify their compliance with the SNUR requirements. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance that is the subject of a proposed or final SNUR, are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec. [emsp14]721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing a SNUR under section 5(a)(2) of TSCA for the
chemical substance identified generically as ethoxylated, propoxylated
diamine diaryl substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which was the subject of PMN P-01-384. This
SNUR would require persons who intend to manufacture, import, or
process the chemical substance for an activity that is designated as a
significant new use to notify EPA at least 90 days before commencing
that activity.
In the Federal Register of April 27, 2012 (77 FR 23236) (FRL-9343-
4), EPA issued a direct final rule which established a SNUR for
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, dialkylethanolamine salt (generic) in
accordance with the procedures at 40 CFR 721.160(c)(3)(i). EPA received
notice of intent to submit adverse comments on this SNUR. Therefore, as
required by Sec. 721.160(c)(3)(ii), EPA withdrew the direct final SNUR
in the Federal Register of July 25, 2012 (77 FR 43520) (FRL-9356-1),
and is now issuing this proposed rule on the chemical substance. The
record for the direct final SNUR on this substance was established as
docket EPA-HQ-OPPT-2011-0577. That record includes information
considered by the Agency in developing the direct final rule and the
notice of intent to submit adverse comments.
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 III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec. [emsp14]721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to this SNUR must comply with the
same notice requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
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
[[Page 75087]]
use must be made after consideration of all relevant factors,
including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substance Subject to This Proposed Rule
This proposed SNUR is for a PMN substance which EPA did not find
that the use scenario described in the PMN triggered the determinations
set forth under TSCA section 5(e). However, EPA does believe that
certain changes from the use scenario described in the PMN could result
in increased exposures, thereby constituting a ``significant new use.''
These so-called ``non-section 5(e) SNURs'' are promulgated pursuant to
Sec. 721.170. EPA has determined that every activity designated as a
``significant new use'' in all non-section 5(e) SNURs issued under
Sec. 721.170 satisfies the two requirements stipulated in Sec.
721.170(c)(2), i.e., these significant new use activities, ``(i) are
different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
PMN Number P-01-384
Chemical name: Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a colorant for aqueous
ink applications. Based on ecological structure activity relationship
(EcoSAR) analysis of test data on analogous amphoteric dyes, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 70 parts per billion (ppb) of the PMN substance in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substance to surface water exceed releases from the use described
in the PMN. For the use described in the PMN, environmental releases
did not exceed 70 ppb for more than 20 days per year. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as described in the
PMN, or any release of a manufacturing waste stream containing the PMN
substance into the waters of the United States without prior chemical
destruction or conversion, may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10308.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMN submitted for the chemical substance
generically identified as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met, as discussed
in Unit IV.
Based upon comments received on the direct final rule, the proposed
SNUR for 40 CFR 721.10308, includes the following changes:
1. Redesignation of paragraph (a)(2)(i) as (a)(2)(ii).
2. Revision of the new paragraph (a)(2)(ii).
3. Addition of new paragraph (a)(2)(i).
B. Objectives
EPA is proposing this SNUR for ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which has undergone PMN review, because the
Agency wants to achieve the following objectives with regard to the
significant new uses designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture, import, or process this chemical substance for the
described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing this chemical substance for the described
significant new use.
EPA would be able to regulate prospective manufacturers,
importers, or processors of this chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substance subject to this proposed
rule has undergone premanufacture review. EPA is soliciting comments on
whether any of the uses proposed as significant new uses are ongoing.
As discussed in the final SNUR rule published in the Federal
Register issue of April 24, 1990, (55 FR 17376), EPA has decided that
the intent of TSCA section 5(a)(1)(B) is best served by designating a
use as a significant new use as of the date of publication of the
previous direct final rule rather than as of the effective date of this
final rule. If uses begun after publication of the direct final were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could
[[Page 75088]]
defeat the SNUR by initiating the significant new use before this final
rule became effective, and then argue that the use was ongoing before
the effective date of the rule. Thus, persons who begin commercial
manufacture, import, or processing of the chemical substances regulated
through this SNUR will have to cease any such activity before the
effective date of this rule. To resume their activities, these persons
would have to comply with all applicable SNUR notice requirements and
wait until the notice review period, including any extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec. [emsp14]721.45(h), the person is
considered exempt from the requirements of the SNUR.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. would list those tests. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. [emsp14]721.1(c), persons submitting a SNUN must
comply with the same notice requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in Sec. 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance during the development of the direct final rule.
EPA's complete economic analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2011-0577.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish a SNUR for one chemical
substance that was the subject of a PMN. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in Title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA is amending the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this 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. As a result, EPA
finds that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this
table without further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
[[Page 75089]]
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant
economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this proposed
rule when promulgated as final. As such, EPA has determined that this
proposed rule, when promulgated as final, would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
E. Executive Order 13132
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
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, (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 10, 2012.
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:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add Sec. 721.10308 to subpart E to read as follows:
Sec. 721.10308 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, dialkylethanolamine salt (PMN P-01-384) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(v).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of the substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2012-30355 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P