83_FR_5625 83 FR 5598 - Modification of Significant New Use of a Certain Chemical Substance

83 FR 5598 - Modification of Significant New Use of a Certain Chemical Substance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 27 (February 8, 2018)

Page Range5598-5602
FR Document2018-02461

EPA is proposing to amend the significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for Oxazolidine, 3,3'-methylenebis[5-methyl-, which was the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN). This action would amend the SNUR to allow certain new uses reported in the SNUN without requiring additional SNUNs and make the lack of certain worker protections a new use. EPA is proposing this amendment based on review of new and existing data as described for the chemical substance. A SNUR requires persons who intend to manufacture (including 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 initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA conducted a review of the notice, made an appropriate determination on the notice, and took such actions as are required with that determination.

Federal Register, Volume 83 Issue 27 (Thursday, February 8, 2018)
[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Proposed Rules]
[Pages 5598-5602]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02461]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0941; FRL-9973-02]
RIN 2070-AB27


Modification of Significant New Use of a Certain Chemical 
Substance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the significant new use rule (SNUR) 
under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 
Oxazolidine, 3,3'-methylenebis[5-methyl-, which was the subject of a 
premanufacture notice (PMN) and a significant new use notice (SNUN). 
This action would amend the SNUR to allow certain new uses reported in 
the SNUN without requiring additional SNUNs and make the lack of 
certain worker protections a new use. EPA is proposing this amendment 
based on review of new and existing data as described for the chemical 
substance. A SNUR requires persons who intend to manufacture (including 
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 initiates EPA's evaluation of the intended use within the 
applicable review period. Manufacture and processing for the 
significant new use would be unable to commence until EPA conducted a 
review of the notice, made an appropriate determination on the notice, 
and took such actions as are required with that determination.

DATES: Comments must be received on or before February 23, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0941, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     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: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division, Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8974; 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, 
process, or use the chemical substance contained in this rule. 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 or processors of the chemical substance 
(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 modified SNUR must 
certify their compliance with the SNUR requirements. The EPA policy in 
support of import certification appears at 40 CFR part 707, subpart B. 
In addition, any persons who export or intend to export the chemical 
substance that is the subject of a final rule 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.

[[Page 5599]]

    Because TSCA now requires EPA to make determinations for all SNUNs 
and the Lautenberg Act includes other changes applying to section 5 
submissions, the appropriateness of the advance compliance provision in 
Sec.  721.45(h) is questionable. Therefore, the Agency would suspend 
the applicability of the provision for these significant new uses, and 
will pursue a resolution of the issue.

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 preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the agency taking?

    EPA is proposing amendments to the SNUR for the chemical substance 
in 40 CFR 721.10461. This proposed action would require persons who 
intend to manufacture or process this chemical substance for an 
activity that is designated as a significant new use by this amended 
rule to notify EPA at least 90 days before commencing that activity. 
The required notification would initiate EPA's evaluation of the 
intended use within the applicable review period. Manufacture and 
processing for the significant new use would be unable to commence 
until EPA conducted a review of the notice, made an appropriate 
determination on the notice, and took such actions as are required with 
that determination.

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. of this document. Once EPA determines that 
a use of a chemical substance is a significant new use and promulgates 
a SNUR, TSCA section 5(a)(1)(B) requires persons to submit a 
significant new use notice (SNUN) to EPA at least 90 days before they 
manufacture or process the chemical substance for that use. Persons who 
must report are described in Sec.  721.5.

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, (but see discussion 
in Unit II.A. of advance compliance under 40 CFR 721.45(h)), 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 these SNURs must 
comply with the same notice requirements and EPA regulatory procedures 
as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, 
these requirements include the information submission requirements of 
TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA 
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 
CFR part 720.
    Once EPA receives a SNUN, EPA must make a determination under TSCA 
section 5(a)(3). If EPA determines that the new use, under the 
conditions of use, is not likely to present unreasonable risk of injury 
to health or the environment, the submitter of the SNUN may immediately 
commence manufacture or processing for the new use. Otherwise, EPA must 
take regulatory action under TSCA section 5(e) or 5(f) to control the 
activities for which it has received the SNUN.

D. Effective Date of Final Rule

    EPA proposes to make the final rule effective 15 days after 
publication. There is good cause for a 15-day effective period, because 
the rule largely relieves a restriction, and because the SNUR 
modification pertains only to new uses, there are no persons who need 
time to adjust existing operations.

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.
    In EPA's determination of the appropriate modification of the scope 
of the existing significant new use for the chemical substance that is 
the subject of this SNUR, EPA considered relevant information about the 
toxicity of the chemical substance, likely human exposures and 
environmental releases associated with possible uses, taking into 
consideration the four bulleted TSCA section 5(a)(2) factors listed in 
this unit.

IV. Substance Subject to a Proposed Significant New Use Rule Amendment

    EPA is proposing to amend the significant new use and recordkeeping 
requirements for one chemical substance in 40 CFR part 721 Subpart E. 
In this unit, EPA provides the following information for the chemical 
substance:
     PMN number and SNUN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for 
non-confidential chemical identities).
     Federal Register publication date and reference for the 
final SNUR previously issued.
     Basis for the Proposed Amendment.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.

PMN Number P-03-325 and SNUN Number S-17-4

    Chemical name: Oxazolidine, 3,3'-methylenebis[5-methyl-
    CAS number: 66204-44-2.
    Federal Register publication date and reference: September 21, 2012 
(77 FR 58666) (FRL-9357-2).
    Basis for the modified significant new use rule: The PMN stated 
that the use of the chemical substance is as a metalworking fluid. The 
original SNUR

[[Page 5600]]

was issued based on meeting the concern criteria at Sec.  
721.170(b)(3)(i), (b)(4)(i), and (b)(ii). EPA identified concerns for 
toxicity to aquatic organisms at concentrations exceeding 40 and 100 
parts per billion (ppb) in surface waters, salt and fresh, 
respectively. EPA also identified concerns for systemic toxicity and 
severe skin and eye irritation. The original SNUR required notification 
if the chemical substance was used other than as a metalworking fluid 
and involving environmental releases during manufacture, processing or 
use that would result in surface water concentrations exceeding a 
concentration of 40 ppb in surface saltwater or 100 ppb in freshwater.
    On April 12, 2017 EPA received a SNUN, S-17-4 for the chemical 
substance for the significant new use as an anti-corrosive agent in 
oilfield operations and hydraulic fluids. The 90-day review period for 
the SNUN expired on October 30, 2017. Based on the activities described 
in the SNUN, a consent order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a determination that 
the substance may present an unreasonable risk of injury to human 
health and the environment.
    EPA identified concerns, based on test data on the substance and on 
new data regarding the expected release of formaldehyde from the 
substance, for skin and eye irritation, neurotoxicity, mutagenicity, 
oncogenicity, allergic responses, and developmental toxicity. In 
addition to the existing water release notification requirements under 
the SNUR, the Consent Order for S-17-4 requires the SNUN submitter to 
provide personal protective equipment and respirators to workers to 
prevent dermal and inhalation exposure, refrain from unloading, 
processing, or using the substance without using enclosed equipment or 
systems, label containers and provide worker training, and use the 
substance only as an anti-corrosive agent in oilfield operations and 
hydraulic fluids and as a metalworking fluid. The modified SNUR 
proposes to designate as a ``significant new use'' the absence of these 
protective measures.
    Recommended testing: The results of a formaldehyde release assay 
(ASTM D5197 or ISO 16000-3) would help characterize the health effects 
of the chemical substance.
    CFR citation: 40 CFR 721.10461.

V. Rationale for the Proposed Rule

    During review of the PMN and SNUN submitted for the chemical 
substance that is the subject of this proposed SNUR, EPA identified 
concerns, as discussed in Unit IV, associated with reasonably foreseen 
changes from the conditions of use identified in the PMN and the 
requirements of the consent order for the SNUN. EPA determined that 
those changes could result in changes in the type or form of exposure 
to the chemical substance and/or increased exposures to the chemical 
substance and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substance.

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. EPA solicits comments on whether any of the uses 
proposed as significant new uses are ongoing. EPA designates February 
8, 2018 as the cutoff date for determining whether the new use is 
ongoing. 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 public release of the proposed SNUR rather than as of the 
effective date of the final rule. If uses begun after public release 
were considered ongoing rather than new, it would be difficult for EPA 
to establish SNUR notice requirements, because a person could defeat 
the SNUR by initiating the proposed significant new use before the rule 
became effective, and then argue that the use was ongoing as of the 
effective date of the final rule.
    Thus, any persons who begin commercial manufacture or processing 
activities with the chemical substance that are not currently a 
significant new use under the current rule but which would be regulated 
as a ``significant new use'' if this proposed rule is finalized, must 
cease any such activity as of the effective date of the rule if and 
when finalized. To resume their activities, these persons would have to 
comply with all applicable SNUR notice requirements and wait until the 
notice review period, including all extensions, expires.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. There is an 
exception: TSCA section 5(b)(1) requires development of test data where 
the chemical substance subject to the SNUR is also subject to a rule, 
order or consent agreement under TSCA section 4 (15 U.S.C. 2603).
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 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. Unit IV. lists recommended 
testing for the subject proposed listed SNUR. 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 http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at 
http://www.sourceoecd.org.
    The recommended testing specified in Unit IV. of the proposed rule 
may not be the only means of addressing the potential risks of the 
chemical substance. However, SNUNs submitted without any test data may 
increase the likelihood that EPA will take action under TSCA section 
5(e) or 5(f), particularly if satisfactory test results have not been 
obtained from a prior PMN or SNUN submitter. EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notice requirements and EPA regulatory procedures as 
persons submitting a PMN, including submission of test data on health 
and environmental effects as described in 40 CFR 720.50. SNUNs must be 
on EPA Form No. 7710-25, generated using e-PMN software, and submitted 
to the Agency in accordance with the procedures set forth in 40 CFR 
721.25 and 40 CFR 720.40. E-PMN software is available electronically at 
https://

[[Page 5601]]

www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-
tsca.

IX. Economic Analysis

    EPA evaluated the potential costs of SNUN requirements for 
potential manufacturers and processors of the chemical substances in 
the proposed rule. The Agency's complete Economic Analysis is available 
in the docket under docket ID number EPA-HQ-OPPT-2011-0941.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed action would modify a SNUR for a chemical substance 
that was the subject of a PMN and a SNUN. 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 
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 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 SNUN submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
rule.
    This 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 will be impacted by this proposed 
rule. As such, EPA has determined that this rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the UMRA sections 202, 203, 204, or 205 (2 
U.S.C. 1501 et seq.).

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 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 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 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.

[[Page 5602]]

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: January 24, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

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

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

0
2. Amend Sec.  721.10461 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2).
0
c. Revise paragraph (b)(1).
0
d. Add paragraph (b)(3).
    The additions and revisions read as follows:


Sec.  721.10461  Oxazolidine, 3,3'-methylenebis[5-methyl-.

    (a) * * *
    (1) The chemical substance identified as oxazolidine, 3,3'-
methylenebis[5-methyl- (PMN P-03-325 and SNUN S-17-4; CAS No. 66204-44-
2) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3), (4) (use of the respirator only applies to 
inhalation exposures to the substance when manufactured in the United 
States), when determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63 (a)(1) and (4) engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 1,000), (a)(6)(v), (vi), (b) 
(concentration set at 0.1 percent), and (c). It is a significant new 
use for the substance to be unloaded, processed and used other than 
with fully enclosed equipment.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b) (concentration set at 0.1 percent), (c), (d), (f), 
(g)(1)(allergic or sensitization response), (ii), (iii), (v), (vi), 
(ix), (2)(i), (ii), (iii), (v), (iv), (3)(i), (ii), (4) (do not release 
to water such that concentrations exceed 40 or 100 ppb in saltwater or 
freshwater, respectively), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use is use other than 
as a metalworking fluid and an anti-corrosive agent in oilfield 
operations and hydraulic fluids.
    (iv) Release to water: Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 40 (saltwater) and N = 100 
(freshwater)).(b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    * * *
    (3) Advance compliance. The provisions of Sec.  721.45(h) do not 
apply to significant new uses to which this section applies.

[FR Doc. 2018-02461 Filed 2-7-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                 5598                  Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Proposed Rules

                                                    • Does not impose an information                     ENVIRONMENTAL PROTECTION                              follow the instructions at http://
                                                 collection burden under the provisions                  AGENCY                                                www.epa.gov/dockets/contacts.html.
                                                 of the Paperwork Reduction Act (44                                                                              Additional instructions on
                                                 U.S.C. 3501 et seq.);                                   40 CFR Part 721                                       commenting or visiting the docket,
                                                    • Is certified as not having a                       [EPA–HQ–OPPT–2011–0941; FRL–9973–02]                  along with more information about
                                                 significant economic impact on a                                                                              dockets generally, is available at http://
                                                                                                         RIN 2070–AB27                                         www.epa.gov/dockets.
                                                 substantial number of small entities
                                                 under the Regulatory Flexibility Act (5                 Modification of Significant New Use of                FOR FURTHER INFORMATION CONTACT: For
                                                 U.S.C. 601 et seq.);                                    a Certain Chemical Substance                          technical information contact: Kenneth
                                                    • Does not contain any unfunded                                                                            Moss, Chemical Control Division, Office
                                                                                                         AGENCY:  Environmental Protection                     of Pollution Prevention and Toxics,
                                                 mandate or significantly or uniquely
                                                                                                         Agency (EPA).                                         Environmental Protection Agency, 1200
                                                 affect small governments, as described
                                                 in the Unfunded Mandates Reform Act                     ACTION: Proposed rule.                                Pennsylvania Ave. NW, Washington, DC
                                                 of 1995 (Pub. L. 104–4);                                                                                      20460–0001; telephone number: (202)
                                                                                                         SUMMARY:   EPA is proposing to amend                  564–8974; email address:
                                                    • Does not have Federalism                           the significant new use rule (SNUR)                   moss.kenneth@epa.gov.
                                                 implications as specified in Executive                  under section 5(a)(2) of the Toxic                      For general information contact: The
                                                 Order 13132 (64 FR 43255, August 10,                    Substances Control Act (TSCA) for                     TSCA-Hotline, ABVI-Goodwill, 422
                                                 1999);                                                  Oxazolidine, 3,3′-methylenebis[5-                     South Clinton Ave., Rochester, NY
                                                    • Is not an economically significant                 methyl-, which was the subject of a                   14620; telephone number: (202) 554–
                                                 regulatory action based on health or                    premanufacture notice (PMN) and a                     1404; email address: TSCA-Hotline@
                                                 safety risks subject to Executive Order                 significant new use notice (SNUN). This               epa.gov.
                                                 13045 (62 FR 19885, April 23, 1997);                    action would amend the SNUR to allow
                                                                                                         certain new uses reported in the SNUN                 SUPPLEMENTARY INFORMATION:
                                                    • Is not a significant regulatory action             without requiring additional SNUNs
                                                 subject to Executive Order 13211 (66 FR                                                                       I. General Information
                                                                                                         and make the lack of certain worker
                                                 28355, May 22, 2001);                                   protections a new use. EPA is proposing               A. Does this action apply to me?
                                                    • Is not subject to requirements of                  this amendment based on review of new                   You may be potentially affected by
                                                 Section 12(d) of the National                           and existing data as described for the                this action if you manufacture, process,
                                                 Technology Transfer and Advancement                     chemical substance. A SNUR requires                   or use the chemical substance contained
                                                 Act of 1995 (15 U.S.C. 272 note) because                persons who intend to manufacture                     in this rule. The following list of North
                                                 application of those requirements would                 (including import) or process this                    American Industrial Classification
                                                 be inconsistent with the CAA; and                       chemical substance for an activity that               System (NAICS) codes is not intended
                                                    • Does not provide EPA with the                      is designated as a significant new use by             to be exhaustive, but rather provides a
                                                 discretionary authority to address, as                  this proposed rule to notify EPA at least             guide to help readers determine whether
                                                 appropriate, disproportionate human                     90 days before commencing that                        this document applies to them.
                                                 health or environmental effects, using                  activity. The required notification                   Potentially affected entities may
                                                 practicable and legally permissible                     initiates EPA’s evaluation of the                     include:
                                                 methods, under Executive Order 12898                    intended use within the applicable                      • Manufacturers or processors of the
                                                 (59 FR 7629, February 16, 1994).                        review period. Manufacture and                        chemical substance (NAICS codes 325
                                                                                                         processing for the significant new use                and 324110), e.g., chemical
                                                    The SIP is not approved to apply on                  would be unable to commence until
                                                 any Indian reservation land or in any                                                                         manufacturing and petroleum refineries.
                                                                                                         EPA conducted a review of the notice,                   This action may also affect certain
                                                 other area where EPA or an Indian tribe                 made an appropriate determination on
                                                 has demonstrated that a tribe has                                                                             entities through pre-existing import
                                                                                                         the notice, and took such actions as are              certification and export notification
                                                 jurisdiction. In those areas of Indian                  required with that determination.
                                                 country, the rule does not have tribal                                                                        rules under TSCA. Chemical importers
                                                                                                         DATES: Comments must be received on                   are subject to the TSCA section 13 (15
                                                 implications as specified by Executive
                                                 Order 13175 (65 FR 67249, November 9,                   or before February 23, 2018.                          U.S.C. 2612) import certification
                                                 2000), nor will it impose substantial                   ADDRESSES: Submit your comments,                      requirements promulgated at 19 CFR
                                                 direct costs on tribal governments or                   identified by docket identification (ID)              12.118 through 12.127 and 19 CFR
                                                 preempt tribal law.                                     number EPA–HQ–OPPT–2011–0941, by                      127.28. Chemical importers must certify
                                                                                                         one of the following methods:                         that the shipment of the chemical
                                                 List of Subjects in 40 CFR Part 52                         • Federal eRulemaking Portal: http://              substance complies with all applicable
                                                                                                         www.regulations.gov. Follow the online                rules and orders under TSCA. Importers
                                                   Environmental protection, Air                         instructions for submitting comments.                 of chemicals subject to a modified
                                                 pollution control, Incorporation by                     Do not submit electronically any                      SNUR must certify their compliance
                                                 reference, Intergovernmental relations,                 information you consider to be                        with the SNUR requirements. The EPA
                                                 Lead, Nitrogen dioxide, Ozone,                          Confidential Business Information (CBI)               policy in support of import certification
                                                 Particulate matter, Reporting and                       or other information whose disclosure is              appears at 40 CFR part 707, subpart B.
                                                 recordkeeping requirements, Sulfur                      restricted by statute.                                In addition, any persons who export or
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                                                 oxides, Volatile organic compounds.                        • Mail: Document Control Office                    intend to export the chemical substance
                                                    Authority: 42 U.S.C. 7401 et seq.                    (7407M), Office of Pollution Prevention               that is the subject of a final rule are
                                                   Dated: January 25, 2018.                              and Toxics (OPPT), Environmental                      subject to the export notification
                                                                                                         Protection Agency, 1200 Pennsylvania                  provisions of TSCA section 12(b) (15
                                                 Onis ‘‘Trey’’ Glenn, III,
                                                                                                         Ave. NW, Washington, DC 20460–0001.                   U.S.C. 2611(b)) (see § 721.20), and must
                                                 Regional Administrator, Region 4.                          • Hand Delivery: To make special                   comply with the export notification
                                                 [FR Doc. 2018–02146 Filed 2–7–18; 8:45 am]              arrangements for hand delivery or                     requirements in 40 CFR part 707,
                                                 BILLING CODE 6560–50–P                                  delivery of boxed information, please                 subpart D.


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                                                                       Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Proposed Rules                                           5599

                                                   Because TSCA now requires EPA to                      this determination by rule after                        • The projected volume of
                                                 make determinations for all SNUNs and                   considering all relevant factors,                     manufacturing and processing of a
                                                 the Lautenberg Act includes other                       including the four bulleted TSCA                      chemical substance.
                                                 changes applying to section 5                           section 5(a)(2) factors, listed in Unit III.            • The extent to which a use changes
                                                 submissions, the appropriateness of the                 of this document. Once EPA determines                 the type or form of exposure of human
                                                 advance compliance provision in                         that a use of a chemical substance is a               beings or the environment to a chemical
                                                 § 721.45(h) is questionable. Therefore,                 significant new use and promulgates a                 substance.
                                                 the Agency would suspend the                            SNUR, TSCA section 5(a)(1)(B) requires                  • The extent to which a use increases
                                                 applicability of the provision for these                persons to submit a significant new use               the magnitude and duration of exposure
                                                 significant new uses, and will pursue a                 notice (SNUN) to EPA at least 90 days                 of human beings or the environment to
                                                 resolution of the issue.                                before they manufacture or process the                a chemical substance.
                                                                                                         chemical substance for that use. Persons                • The reasonably anticipated manner
                                                 B. What should I consider as I prepare                  who must report are described in                      and methods of manufacturing,
                                                 my comments for EPA?                                    § 721.5.                                              processing, distribution in commerce,
                                                    1. Submitting CBI. Do not submit this                                                                      and disposal of a chemical substance.
                                                                                                         C. Applicability of General Provisions
                                                 information to EPA through                                                                                      In addition to these factors
                                                 regulations.gov or email. Clearly mark                    General provisions for SNURs appear                 enumerated in TSCA section 5(a)(2), the
                                                 the part or all of the information that                 in 40 CFR part 721, subpart A. These                  statute authorized EPA to consider any
                                                 you claim to be CBI. For CBI                            provisions describe persons subject to                other relevant factors.
                                                 information in a disk or CD–ROM that                    the rule, recordkeeping requirements,                   In EPA’s determination of the
                                                 you mail to EPA, mark the outside of the                exemptions to reporting requirements,                 appropriate modification of the scope of
                                                 disk or CD–ROM as CBI and then                          (but see discussion in Unit II.A. of                  the existing significant new use for the
                                                 identify electronically within the disk or              advance compliance under 40 CFR                       chemical substance that is the subject of
                                                 CD–ROM the specific information that                    721.45(h)), and applicability of the rule             this SNUR, EPA considered relevant
                                                 is claimed as CBI. In addition to one                   to uses occurring before the effective                information about the toxicity of the
                                                 complete version of the comment that                    date of the rule. Provisions relating to              chemical substance, likely human
                                                 includes information claimed as CBI, a                  user fees appear at 40 CFR part 700.                  exposures and environmental releases
                                                 copy of the comment that does not                       According to § 721.1(c), persons subject              associated with possible uses, taking
                                                 contain the information claimed as CBI                  to these SNURs must comply with the                   into consideration the four bulleted
                                                 must be submitted for inclusion in the                  same notice requirements and EPA                      TSCA section 5(a)(2) factors listed in
                                                 public docket. Information so marked                    regulatory procedures as submitters of                this unit.
                                                 will not be disclosed except in                         PMNs under TSCA section 5(a)(1)(A). In
                                                                                                         particular, these requirements include                IV. Substance Subject to a Proposed
                                                 accordance with procedures set forth in                                                                       Significant New Use Rule Amendment
                                                 40 CFR part 2.                                          the information submission
                                                    2. Tips for preparing your comments.                 requirements of TSCA section 5(b) and                   EPA is proposing to amend the
                                                 When preparing and submitting your                      5(d)(1), the exemptions authorized by                 significant new use and recordkeeping
                                                 comments, see the commenting tips at                    TSCA section 5(h)(1), (h)(2), (h)(3), and             requirements for one chemical
                                                 http://www.epa.gov/dockets/                             (h)(5), and the regulations at 40 CFR                 substance in 40 CFR part 721 Subpart E.
                                                 comments.html.                                          part 720.                                             In this unit, EPA provides the following
                                                                                                           Once EPA receives a SNUN, EPA                       information for the chemical substance:
                                                 II. Background                                          must make a determination under TSCA                    • PMN number and SNUN number.
                                                 A. What action is the agency taking?                    section 5(a)(3). If EPA determines that                 • Chemical name (generic name, if
                                                                                                         the new use, under the conditions of                  the specific name is claimed as CBI).
                                                   EPA is proposing amendments to the                    use, is not likely to present                           • Chemical Abstracts Service (CAS)
                                                 SNUR for the chemical substance in 40                   unreasonable risk of injury to health or              number (if assigned for non-confidential
                                                 CFR 721.10461. This proposed action                     the environment, the submitter of the                 chemical identities).
                                                 would require persons who intend to                     SNUN may immediately commence                           • Federal Register publication date
                                                 manufacture or process this chemical                    manufacture or processing for the new                 and reference for the final SNUR
                                                 substance for an activity that is                       use. Otherwise, EPA must take                         previously issued.
                                                 designated as a significant new use by                  regulatory action under TSCA section                    • Basis for the Proposed Amendment.
                                                 this amended rule to notify EPA at least                5(e) or 5(f) to control the activities for              • Tests recommended by EPA to
                                                 90 days before commencing that                          which it has received the SNUN.                       provide sufficient information to
                                                 activity. The required notification                                                                           evaluate the chemical substance (see
                                                 would initiate EPA’s evaluation of the                  D. Effective Date of Final Rule                       Unit VII. for more information).
                                                 intended use within the applicable                         EPA proposes to make the final rule                  • CFR citation assigned in the
                                                 review period. Manufacture and                          effective 15 days after publication.                  regulatory text section of this rule.
                                                 processing for the significant new use                  There is good cause for a 15-day
                                                 would be unable to commence until                                                                             PMN Number P–03–325 and SNUN
                                                                                                         effective period, because the rule largely
                                                 EPA conducted a review of the notice,                                                                         Number S–17–4
                                                                                                         relieves a restriction, and because the
                                                 made an appropriate determination on                    SNUR modification pertains only to                      Chemical name: Oxazolidine, 3,3′-
                                                 the notice, and took such actions as are                new uses, there are no persons who                    methylenebis[5-methyl-
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                                                 required with that determination.                       need time to adjust existing operations.                CAS number: 66204–44–2.
                                                                                                                                                                 Federal Register publication date and
                                                 B. What is the agency’s authority for                   III. Significant New Use Determination                reference: September 21, 2012 (77 FR
                                                 taking this action?                                        Section 5(a)(2) of TSCA states that                58666) (FRL–9357–2).
                                                    Section 5(a)(2) of TSCA (15 U.S.C.                   EPA’s determination that a use of a                     Basis for the modified significant new
                                                 2604(a)(2)) authorizes EPA to determine                 chemical substance is a significant new               use rule: The PMN stated that the use
                                                 that a use of a chemical substance is a                 use must be made after consideration of               of the chemical substance is as a
                                                 ‘‘significant new use.’’ EPA must make                  all relevant factors, including:                      metalworking fluid. The original SNUR


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                                                 5600                  Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Proposed Rules

                                                 was issued based on meeting the                         discussed in Unit IV, associated with                 4 covering the chemical substance,
                                                 concern criteria at § 721.170(b)(3)(i),                 reasonably foreseen changes from the                  persons are required only to submit test
                                                 (b)(4)(i), and (b)(ii). EPA identified                  conditions of use identified in the PMN               data in their possession or control and
                                                 concerns for toxicity to aquatic                        and the requirements of the consent                   to describe any other data known to or
                                                 organisms at concentrations exceeding                   order for the SNUN. EPA determined                    reasonably ascertainable by them (see
                                                 40 and 100 parts per billion (ppb) in                   that those changes could result in                    § 720.50). However, upon review of
                                                 surface waters, salt and fresh,                         changes in the type or form of exposure               PMNs and SNUNs, the Agency has the
                                                 respectively. EPA also identified                       to the chemical substance and/or                      authority to require appropriate testing.
                                                 concerns for systemic toxicity and                      increased exposures to the chemical                   Unit IV. lists recommended testing for
                                                 severe skin and eye irritation. The                     substance and/or changes in the                       the subject proposed listed SNUR.
                                                 original SNUR required notification if                  reasonably anticipated manner and                     Descriptions of tests are provided for
                                                 the chemical substance was used other                   methods of manufacturing, processing,                 informational purposes. EPA strongly
                                                 than as a metalworking fluid and                        distribution in commerce, and disposal                encourages persons, before performing
                                                 involving environmental releases during                 of the chemical substance.                            any testing, to consult with the Agency
                                                 manufacture, processing or use that                                                                           pertaining to protocol selection. To
                                                                                                         VI. Applicability of the Proposed Rule
                                                 would result in surface water                                                                                 access the OCSPP test guidelines
                                                                                                         to Uses Occurring Before Effective Date
                                                 concentrations exceeding a                                                                                    referenced in this document
                                                                                                         of the Final Rule
                                                 concentration of 40 ppb in surface                                                                            electronically, please go to http://
                                                 saltwater or 100 ppb in freshwater.                        To establish a significant new use,                www.epa.gov/ocspp and select ‘‘Test
                                                    On April 12, 2017 EPA received a                     EPA must determine that the use is not                Methods and Guidelines.’’ The
                                                 SNUN, S–17–4 for the chemical                           ongoing. EPA solicits comments on                     Organisation for Economic Co-operation
                                                 substance for the significant new use as                whether any of the uses proposed as                   and Development (OECD) test
                                                 an anti-corrosive agent in oilfield                     significant new uses are ongoing. EPA                 guidelines are available from the OECD
                                                 operations and hydraulic fluids. The 90-                designates February 8, 2018 as the cutoff             Bookshop at http://
                                                 day review period for the SNUN expired                  date for determining whether the new                  www.oecdbookshop.org or SourceOECD
                                                 on October 30, 2017. Based on the                       use is ongoing. EPA has decided that the              at http://www.sourceoecd.org.
                                                 activities described in the SNUN, a                     intent of TSCA section 5(a)(1)(B) is best
                                                                                                                                                                  The recommended testing specified in
                                                 consent order was issued under TSCA                     served by designating a use as a
                                                                                                                                                               Unit IV. of the proposed rule may not
                                                 sections 5(a)(3)(B)(ii)(I) and                          significant new use as of the date of
                                                                                                                                                               be the only means of addressing the
                                                 5(e)(1)(A)(ii)(I), based on a                           public release of the proposed SNUR
                                                                                                                                                               potential risks of the chemical
                                                 determination that the substance may                    rather than as of the effective date of the
                                                                                                                                                               substance. However, SNUNs submitted
                                                 present an unreasonable risk of injury to               final rule. If uses begun after public
                                                                                                                                                               without any test data may increase the
                                                 human health and the environment.                       release were considered ongoing rather
                                                                                                                                                               likelihood that EPA will take action
                                                    EPA identified concerns, based on test               than new, it would be difficult for EPA
                                                                                                                                                               under TSCA section 5(e) or 5(f),
                                                 data on the substance and on new data                   to establish SNUR notice requirements,
                                                                                                                                                               particularly if satisfactory test results
                                                 regarding the expected release of                       because a person could defeat the SNUR
                                                                                                                                                               have not been obtained from a prior
                                                 formaldehyde from the substance, for                    by initiating the proposed significant
                                                                                                                                                               PMN or SNUN submitter. EPA
                                                 skin and eye irritation, neurotoxicity,                 new use before the rule became
                                                                                                                                                               recommends that potential SNUN
                                                 mutagenicity, oncogenicity, allergic                    effective, and then argue that the use
                                                                                                                                                               submitters contact EPA early enough so
                                                 responses, and developmental toxicity.                  was ongoing as of the effective date of
                                                                                                                                                               that they will be able to conduct the
                                                 In addition to the existing water release               the final rule.
                                                                                                            Thus, any persons who begin                        appropriate tests.
                                                 notification requirements under the
                                                                                                         commercial manufacture or processing                     SNUN submitters should be aware
                                                 SNUR, the Consent Order for S–17–4
                                                                                                         activities with the chemical substance                that EPA will be better able to evaluate
                                                 requires the SNUN submitter to provide
                                                                                                         that are not currently a significant new              SNUNs which provide detailed
                                                 personal protective equipment and
                                                                                                         use under the current rule but which                  information on the following:
                                                 respirators to workers to prevent dermal
                                                 and inhalation exposure, refrain from                   would be regulated as a ‘‘significant                    • Human exposure and
                                                 unloading, processing, or using the                     new use’’ if this proposed rule is                    environmental release that may result
                                                 substance without using enclosed                        finalized, must cease any such activity               from the significant new use of the
                                                 equipment or systems, label containers                  as of the effective date of the rule if and           chemical substances.
                                                 and provide worker training, and use                    when finalized. To resume their                          • Information on risks posed by the
                                                 the substance only as an anti-corrosive                 activities, these persons would have to               chemical substances compared to risks
                                                 agent in oilfield operations and                        comply with all applicable SNUR notice                posed by potential substitutes.
                                                 hydraulic fluids and as a metalworking                  requirements and wait until the notice                VIII. SNUN Submissions
                                                 fluid. The modified SNUR proposes to                    review period, including all extensions,
                                                 designate as a ‘‘significant new use’’ the              expires.                                                According to 40 CFR 721.1(c), persons
                                                 absence of these protective measures.                                                                         submitting a SNUN must comply with
                                                                                                         VII. Test Data and Other Information                  the same notice requirements and EPA
                                                    Recommended testing: The results of
                                                 a formaldehyde release assay (ASTM                        EPA recognizes that TSCA section 5                  regulatory procedures as persons
                                                 D5197 or ISO 16000–3) would help                        does not require the development of any               submitting a PMN, including
                                                 characterize the health effects of the                  particular test data before submission of             submission of test data on health and
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                                                 chemical substance.                                     a SNUN. There is an exception: TSCA                   environmental effects as described in 40
                                                    CFR citation: 40 CFR 721.10461.                      section 5(b)(1) requires development of               CFR 720.50. SNUNs must be on EPA
                                                                                                         test data where the chemical substance                Form No. 7710–25, generated using e-
                                                 V. Rationale for the Proposed Rule                      subject to the SNUR is also subject to a              PMN software, and submitted to the
                                                   During review of the PMN and SNUN                     rule, order or consent agreement under                Agency in accordance with the
                                                 submitted for the chemical substance                    TSCA section 4 (15 U.S.C. 2603).                      procedures set forth in 40 CFR 721.25
                                                 that is the subject of this proposed                      In the absence of a rule, order, or                 and 40 CFR 720.40. E–PMN software is
                                                 SNUR, EPA identified concerns, as                       consent agreement under TSCA section                  available electronically at https://


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                                                                       Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Proposed Rules                                            5601

                                                 www.epa.gov/reviewing-new-chemicals-                    Agency, the annual burden is estimated                any unfunded mandate, or otherwise
                                                 under-toxic-substances-control-act-tsca.                to average between 30 and 170 hours                   have any effect on small governments
                                                                                                         per response. This burden estimate                    subject to the requirements of sections
                                                 IX. Economic Analysis
                                                                                                         includes the time needed to review                    202, 203, 204, or 205 of the UMRA
                                                   EPA evaluated the potential costs of                  instructions, search existing data                    sections 202, 203, 204, or 205 (2 U.S.C.
                                                 SNUN requirements for potential                         sources, gather and maintain the data                 1501 et seq.).
                                                 manufacturers and processors of the                     needed, and complete, review, and
                                                 chemical substances in the proposed                     submit the required SNUN.                             E. Executive Order 13132
                                                 rule. The Agency’s complete Economic                      Send any comments about the
                                                                                                                                                                  This action would not have a
                                                 Analysis is available in the docket                     accuracy of the burden estimate, and
                                                                                                                                                               substantial direct effect on States, on the
                                                 under docket ID number EPA–HQ–                          any suggested methods for minimizing
                                                                                                                                                               relationship between the national
                                                 OPPT–2011–0941.                                         respondent burden, including through
                                                                                                                                                               government and the States, or on the
                                                                                                         the use of automated collection
                                                 X. Statutory and Executive Order                                                                              distribution of power and
                                                                                                         techniques, to the Director, Collection
                                                 Reviews                                                                                                       responsibilities among the various
                                                                                                         Strategies Division, Office of
                                                 A. Executive Order 12866                                Environmental Information (2822T),                    levels of government, as specified in
                                                                                                         Environmental Protection Agency, 1200                 Executive Order 13132, entitled
                                                   This proposed action would modify a                                                                         ‘‘Federalism’’ (64 FR 43255, August 10,
                                                 SNUR for a chemical substance that was                  Pennsylvania Ave. NW, Washington, DC
                                                                                                         20460–0001. Please remember to                        1999).
                                                 the subject of a PMN and a SNUN. The
                                                 Office of Management and Budget                         include the OMB control number in any                 F. Executive Order 13175
                                                 (OMB) has exempted these types of                       correspondence, but do not submit any
                                                 actions from review under Executive                     completed forms to this address.                         This proposed rule would not have
                                                 Order 12866, entitled Regulatory                                                                              Tribal implications because it is not
                                                                                                         C. Regulatory Flexibility Act (RFA)
                                                 Planning and Review (58 FR 51735,                                                                             expected to have substantial direct
                                                                                                           On February 18, 2012, EPA certified                 effects on Indian Tribes. This proposed
                                                 October 4, 1993).
                                                                                                         pursuant to RFA section 605(b) (5 U.S.C.              rule would not significantly nor
                                                 B. Paperwork Reduction Act (PRA)                        601 et seq.), that promulgation of a                  uniquely affect the communities of
                                                    According to PRA, 44 U.S.C. 3501 et                  SNUR does not have a significant                      Indian Tribal governments, nor does it
                                                 seq., an Agency may not conduct or                      economic impact on a substantial                      involve or impose any requirements that
                                                 sponsor, and a person is not required to                number of small entities where the                    affect Indian Tribes. Accordingly, the
                                                 respond to a collection of information                  following are true:                                   requirements of Executive Order 13175,
                                                                                                           1. A significant number of SNUNs                    entitled ‘‘Consultation and
                                                 that requires OMB approval under PRA,
                                                                                                         would not be submitted by small                       Coordination with Indian Tribal
                                                 unless it has been approved by OMB
                                                                                                         entities in response to the SNUR.                     Governments’’ (65 FR 67249, November
                                                 and displays a currently valid OMB
                                                                                                           2. The SNUN submitted by any small                  9, 2000), do not apply to this proposed
                                                 control number. The OMB control
                                                                                                         entity would not cost significantly more              rule.
                                                 numbers for EPA’s regulations in title 40
                                                                                                         than $8,300.
                                                 of the CFR, after appearing in the                        A copy of that certification is                     G. Executive Order 13045
                                                 Federal Register, are listed in 40 CFR                  available in the docket for this rule.
                                                 part 9, and included on the related                       This proposed rule is within the                      This action is not subject to Executive
                                                 collection instrument or form, if                       scope of the February 18, 2012                        Order 13045, entitled ‘‘Protection of
                                                 applicable. EPA is amending the table in                certification. Based on the Economic                  Children from Environmental Health
                                                 40 CFR part 9 to list the OMB approval                  Analysis discussed in Unit IX. and                    Risks and Safety Risks’’ (62 FR 19885,
                                                 number for the information collection                   EPA’s experience promulgating SNURs                   April 23, 1997), because this is not an
                                                 requirements contained in this rule.                    (discussed in the certification), EPA                 economically significant regulatory
                                                 This listing of the OMB control numbers                 believes that the following are true:                 action as defined by Executive Order
                                                 and their subsequent codification in the                  • A significant number of SNUNs                     12866, and this action does not address
                                                 CFR satisfies the display requirements                  would not be submitted by small                       environmental health or safety risks
                                                 of PRA and OMB’s implementing                           entities in response to the SNUR.                     disproportionately affecting children.
                                                 regulations at 5 CFR part 1320. This                      • Submission of the SNUN would not
                                                 Information Collection Request (ICR)                    cost any small entity significantly more              H. Executive Order 13211
                                                 was previously subject to public notice                 than $8,300.
                                                 and comment prior to OMB approval,                                                                              This action is not subject to Executive
                                                                                                           Therefore, the promulgation of the                  Order 13211, entitled ‘‘Actions
                                                 and given the technical nature of the                   SNUR would not have a significant
                                                 table, EPA finds that further notice and                                                                      Concerning Regulations That
                                                                                                         economic impact on a substantial                      Significantly Affect Energy Supply,
                                                 comment to amend it is unnecessary. As                  number of small entities.
                                                 a result, EPA finds that there is ‘‘good                                                                      Distribution, or Use’’ (66 FR 28355, May
                                                 cause’’ under section 553(b)(3)(B) of the               D. Unfunded Mandates Reform Act                       22, 2001), because this action is not
                                                 Administrative Procedure Act, 5 U.S.C.                  (UMRA)                                                expected to affect energy supply,
                                                 553(b)(3)(B), to amend this table without                 Based on EPA’s experience with                      distribution, or use and because this
                                                 further notice and comment.                             proposing and finalizing SNURs, State,                action is not a significant regulatory
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                                                    The information collection                           local, and Tribal governments have not                action under Executive Order 12866.
                                                 requirements related to this action have                been impacted by these rulemakings,                   I. National Technology Transfer and
                                                 already been approved by OMB                            and EPA does not have any reasons to                  Advancement Act (NTTAA)
                                                 pursuant to PRA under OMB control                       believe that any State, local, or Tribal
                                                 number 2070–0012 (EPA ICR No. 574).                     government will be impacted by this                     In addition, since this action does not
                                                 This action does not impose any burden                  proposed rule. As such, EPA has                       involve any technical standards,
                                                 requiring additional OMB approval. If                   determined that this rule would not                   NTTAA section 12(d) (15 U.S.C. 272
                                                 an entity were to submit a SNUN to the                  impose any enforceable duty, contain                  note), does not apply to this action.


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                                                 5602                  Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Proposed Rules

                                                 J. Executive Order 12898                                § 721.10461 Oxazolidine, 3,3′-                           (ii) Hazard communication program.
                                                                                                         methylenebis[5-methyl-.                               Requirements as specified in
                                                    This action does not entail special
                                                 considerations of environmental justice                    (a) * * *                                          § 721.72(a), (b) (concentration set at 0.1
                                                 related issues as delineated by                            (1) The chemical substance identified              percent), (c), (d), (f), (g)(1)(allergic or
                                                 Executive Order 12898, entitled                         as oxazolidine, 3,3′-methylenebis[5-                  sensitization response), (ii), (iii), (v),
                                                 ‘‘Federal Actions to Address                            methyl- (PMN P–03–325 and SNUN S–                     (vi), (ix), (2)(i), (ii), (iii), (v), (iv), (3)(i),
                                                 Environmental Justice in Minority                       17–4; CAS No. 66204–44–2) is subject to               (ii), (4) (do not release to water such that
                                                 Populations and Low-Income                              reporting under this section for the                  concentrations exceed 40 or 100 ppb in
                                                 Populations’’ (59 FR 7629, February 16,                 significant new uses described in                     saltwater or freshwater, respectively),
                                                 1994).                                                  paragraph (a)(2) of this section.                     and (g)(5). Alternative hazard and
                                                                                                            (2) The significant new uses are:                  warning statements that meet the
                                                 List of Subjects in 40 CFR Part 721                        (i) Protection in the workplace.                   criteria of the Globally Harmonized
                                                   Environmental protection, Chemicals,                  Requirements as specified in                          System (GHS) and OSHA Hazard
                                                 Hazardous substances, Reporting and                     § 721.63(a)(1), (2)(i), (3), (4) (use of the          Communication Standard may be used.
                                                 recordkeeping requirements.                             respirator only applies to inhalation                    (iii) Industrial, commercial, and
                                                                                                         exposures to the substance when                       consumer activities. Requirements as
                                                   Dated: January 24, 2018.                                                                                    specified in § 721.80. A significant new
                                                 Jeffery T. Morris,
                                                                                                         manufactured in the United States),
                                                                                                         when determining which persons are                    use is use other than as a metalworking
                                                 Director, Office of Pollution Prevention and                                                                  fluid and an anti-corrosive agent in
                                                 Toxics.
                                                                                                         reasonably likely to be exposed as
                                                                                                         required for § 721.63 (a)(1) and (4)                  oilfield operations and hydraulic fluids.
                                                   Therefore, it is proposed that 40 CFR                 engineering control measures (e.g.,                      (iv) Release to water: Requirements as
                                                 part 721 be amended as follows:                         enclosure or confinement of the                       specified in § 721.90(a)(4), (b)(4), and
                                                                                                         operation, general and local ventilation)             (c)(4) (N = 40 (saltwater) and N = 100
                                                 PART 721—[AMENDED]                                                                                            (freshwater)).(b) * * *
                                                                                                         or administrative control measures (e.g.,
                                                                                                         workplace policies and procedures)                       (1) Recordkeeping. Recordkeeping
                                                 ■ 1. The authority citation for part 721
                                                                                                         shall be considered and implemented to                requirements as specified in
                                                 continues to read as follows:
                                                                                                         prevent exposure, where feasible, (a)(5)              § 721.125(a) through (i) and (k) are
                                                   Authority: 15 U.S.C. 2604, 2607, and                                                                        applicable to manufacturers and
                                                 2625(c).
                                                                                                         (respirators must provide a National
                                                                                                         Institute for Occupational Safety and                 processors of this substance.
                                                 ■ 2. Amend § 721.10461 as follows:                      Health (NIOSH) assigned protection                       * * *
                                                 ■ a. Revise paragraph (a)(1).                           factor (APF) of at least 1,000), (a)(6)(v),              (3) Advance compliance. The
                                                 ■ b. Revise paragraph (a)(2).                           (vi), (b) (concentration set at 0.1                   provisions of § 721.45(h) do not apply to
                                                 ■ c. Revise paragraph (b)(1).                           percent), and (c). It is a significant new            significant new uses to which this
                                                 ■ d. Add paragraph (b)(3).                              use for the substance to be unloaded,                 section applies.
                                                   The additions and revisions read as                   processed and used other than with                    [FR Doc. 2018–02461 Filed 2–7–18; 8:45 am]
                                                 follows:                                                fully enclosed equipment.                             BILLING CODE 6560–50–P
daltland on DSKBBV9HB2PROD with PROPOSALS




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Document Created: 2018-02-08 00:16:21
Document Modified: 2018-02-08 00:16:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before February 23, 2018.
ContactFor technical information contact: Kenneth Moss, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8974; email
FR Citation83 FR 5598 
RIN Number2070-AB27
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements

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