Document ID: EPA-HQ-OPPT-2011-0577-0218
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Ethoxylated, Propoxylated Diamine Diaryl Substituted Phenylmethane Ester with Alkenylsuccinate, Dialkylethanolamine Salt
Posted Date: 2013-05-01T04:00Z

[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Rules and Regulations]
[Pages 25388-25392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10306]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2011-0577; FRL-9385-1]
RIN 2070-AB27

Significant New Use Rule on Ethoxylated, Propoxylated Diamine 
Diaryl Substituted Phenylmethane Ester With Alkenylsuccinate, 
Dialkylethanolamine Salt

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing 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 requires persons who intend to 
manufacture, import, or process this 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. 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: This final rule is effective May 31, 2013.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2011-0577, is available at 
http://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 
http://www.epa.gov/dockets.

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-

[[Page 25389]]

1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substance generically identified 
as ethoxylated, propoxylated diamine diaryl substituted phenylmethane 
ester with alkenylsuccinate, dialkylethanolamine salt. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this document applies to them. Potentially 
affected entities may include:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    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 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 this 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 a significant new use rule (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 final SNUR designates as a significant 
new use the use of the substance other than as an ink colorant, as 
described in the amended PMN. This action requires 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 25236) (FRL-9343-
4), EPA issued a direct final SNUR on this chemical substance in 
accordance with the procedures at Sec.  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 subsequently proposed a SNUR on the chemical substance using notice 
and comment procedures in the Federal Register of December 19, 2012 (77 
FR 75085) (FRL-9370-1). 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 proposed rule.
    EPA did not receive comments on the proposed rule. However, during 
the public comment period, the PMN submitter relinquished the 
confidentiality claim in the original PMN on the use description of the 
PMN substance. Therefore, EPA is issuing the final rule on the chemical 
substance that identifies, under Sec.  721.80(j) in the regulatory 
text, the specific use in the PMN as an ink colorant.

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.  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 final rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the rule to uses occurring before the effective date 
of the final rule. Provisions relating to user fees appear at 40 CFR 
part 700. According to Sec.  721.1(c), persons subject to these SNURs 
must comply with the same notice requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions 
authorized by TSCA sections 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 sections 5(e), 5(f), 6, or 7 to 
control the activities for which it has received the SNUN. If EPA does 
not take action, EPA is required under TSCA section 5(g) to explain in 
the Federal Register its reasons for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substance that is the subject of this final 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. Rationale and Objectives of the Final 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

[[Page 25390]]

Sec.  [emsp14]721.170 were met, as discussed in Unit IV. of the 
proposed rule.

B. Objectives

    EPA is issuing this final SNUR for the chemical substance 
generically identified as ethoxylated, propoxylated diamine diaryl 
substituted phenylmethane ester with alkenylsuccinate, 
dialkylethanolamine salt, which has undergone premanufacture review, 
because the Agency wants to achieve the following objectives with 
regard to the significant new uses designated in this final rule:
     EPA will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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 December 19, 2012 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, import, or processing 
of the chemical substance identified generically as ethoxylated, 
propoxylated diamine diaryl substituted phenylmethane ester with 
alkenylsuccinate, dialkylethanolamine salt (PMN P-01-384) for any of 
the significant new uses designated in the proposed SNUR 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 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. Recommended testing for this 
substance were described in Unit IV. of the proposed rule. 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.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substance.
     Potential benefits of the chemical substance.
     Information on risks posed by the chemical substance 
compared to risks posed by potential substitutes.

VII. SNUN Submissions

    According to Sec.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting a PMN, including submission of test 
data on health and environmental effects as described in 40 CFR 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.  720.40 and Sec.  721.25. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

VIII. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substance 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.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes a SNUR for a chemical substance that 
was the subject of a PMN. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this final rule. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to

[[Page 25391]]

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 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 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 (RFA)

    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.
    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 final 
rule.
    This final 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 (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 will be impacted by this final rule. 
As such, EPA has determined that this final rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

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 (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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 final 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

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: April 24, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. In Sec.  [emsp14]9.1, add the following section in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:

[[Page 25392]]

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

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                                                            OMB Control
                     40 CFR Citation                            No.
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                                * * * * *
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               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
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721.10308...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  [emsp14]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) (ink colorant).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2013-10306 Filed 4-30-13; 8:45 am]
BILLING CODE 6560-50-P