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)

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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