[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36610-36612]
[FR Doc No: 2011-15555]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64691; File No. SR-NASDAQ-2011-079]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Implementation Date for Several Rules in Connection With
Trading System Enhancements

 June 16, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on June 8, 2011, The NASDAQ Stock Market LLC (``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ is filing with the Securities and Exchange Commission
(``Commission'') a proposal for the NASDAQ Options Market (``NOM'') to
extend the time period where certain rules, in connection with several
trading system enhancements, are implemented from May 2011 to August
2011, as described below. The Exchange will announce the specific
implementation schedule by Options Trader Alert, once the rollout
schedule is finalized.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to extend the time
period where certain rules, in connection with several trading system
enhancements, are implemented from May 2011 to August 2011. The
Exchange intends to rollout these enhancements in August 2011.\3\ The
Exchange will announce the specific implementation schedule by Options
Trader Alert, once the rollout schedule is finalized.
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    \3\ The Commission notes that NASDAQ intends to begin
implementation of these two rules by August 31, with the specific
implementation scheduled to be announced via Options Trader Alert,
as stated above. In the event that this does not occur by August 31,
NASDAQ has represented that it will file a proposed rule change to
establish the revised time period. See e-mail from Edith Callahan,
Principal Associate General Counsel, The NASDAQ OMX Group, Inc., to
Steve L. Kuan, Special Counsel, Division of Trading and Markets,
Commission, on June 16, 2011.
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    Previously, the Exchange filed two proposed rule changes indicating
an implementation date of May 31, 2011.\4\ The first one amended
various rules to: (a) Permit market maker assignment by option rather
than by series; (b) adopt a $5 quotation spread parameter; and (c)
amend the quoting requirement for Market Makers.\5\ The second one
modified the procedures for the opening of trading at the start of the
trading day and at the resumption of trading following a trading halt
on NOM.\6\ The implementation of both of those rules is now scheduled
for August 2011. At the time the Exchange filed those two filings, the
Exchange expected implementation to occur in May. However, since that
time, additional enhancements have been finalized and filed as well,\7\
all of which are intended to be implemented together. The Exchange
needed more time to implement the enhancements. As a result,
participants will have additional time to adapt to the enhancements.
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    \4\ The Exchange has also filed other proposed rule changes in
connection with these enhancements, but established the
implementation date as on or about August 1, 2011, such that it does
not need to be revised.
    \5\ Securities Exchange Act Release No. 64054 (March 8, 2011),
76 FR 14111 (March 15, 2011) (SR-NASDAQ-2011-036). The
implementation date in the filing was May 31, 2011.
    \6\ Securities Exchange Act Release No. 64463 (May 11, 2011), 76
FR 28257 (May 16, 2011) (SR-NASDAQ-2011-037). The implementation
date in the filing was May 31, 2011.
    \7\ See e.g., Securities Exchange Act Release No. 64312 (April
20, 2011), 76 FR 23351 (April 26, 2011) (SR-NASDAQ-2011-053).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system, and, in general, to protect
investors and the public interest, because it merely extends an
implementation period for two NOM enhancements, which should provide
NOM Participants additional time to adapt to the enhancements.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
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    The Exchange has requested the Commission to waive the 30-day
operative delay so that NOM Participants will know that these two rules
are not yet implemented. The Exchange noted that it will announce the
specific implementation schedule by Options Trader Alert, once the
rollout schedule is finalized. The Commission hereby grants the
Exchange's request and believes such waiver is reasonable as it would
provide notice to NOM participants with respect to the change in
implementation date and is consistent with the protection of investors
and the public interest.\12\ Accordingly, the Commission designates the
proposed rule change operative upon filing with the Commission.
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    \12\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-079 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2011-079. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2011-079 and should be submitted on or before
July 13, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-15555 Filed 6-21-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Rules and Regulations]
[Pages 13531-13543]
[FR Doc No: 2019-06624]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0575; FRL-9991-19-OCSPP]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 13 chemical substances which
are the subject of premanufacture notices (PMNs). This action requires
persons to notify EPA least 90 days before commencing manufacture
(defined by statute to include import) or processing of any of these 13
chemical substances for an activity that is designated as a significant
new use by this rule. The required notification initiates EPA's
evaluation of the intended use within the applicable review period.
Persons may not commence manufacture or processing for the significant
new use until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required as a result of that determination.

DATES: This rule is effective on June 4, 2019. For purposes of judicial
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 19,
2019.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; 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 substances 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 one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after May 6, 2019 are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for 13 chemical
substances which were the subject of PMNs P-16-192, P-16-354 and P-16-
355, P-16-380 through P-16-385,
P-16-483 and P-16-484, P-16-575, and P-16-581. These SNURs require
persons who intend to manufacture or process any of these chemical
substances for an activity that is designated as a significant new use
to notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register of October 16, 2018 (83 FR
52179) (FRL-9984-93), EPA proposed a SNUR for these 13 chemical
substances in 40 CFR part 721 subpart E. More information on the
specific chemical substances subject to this final rule can be found in
the Federal Register documents proposing the SNUR. The record for the
SNUR was established in the docket under docket ID number EPA-HQ-OPPT-
2017-0575. That docket includes information considered by the Agency in
developing the proposed and final rules. EPA received a number of
public comments on this rule. Those comments and EPA's responses are
found in Unit IV.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and taken such actions as are required in association
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in
Unit V., the general SNUR provisions are found at 40 CFR part 721,
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  721.1(c), persons subject to these SNURs must comply with the
same SNUN 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 either determine that the significant new use
is not likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
before the manufacture or processing for the significant new use can
commence. If EPA determines that the significant new use is not likely
to present an unreasonable risk, EPA is required under TSCA section
5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.

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 authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from 15 entities on the proposed rule.
The Agency's responses are described below.

Anonymous and Generally Supportive Comments

    EPA received a number of anonymous (and submitter-identified)
comments in support of the Agency's proposed Significant New Use Rules
(SNURs). These comments were general in nature, citing the importance
of Agency review of these 13 chemicals to protect human health and the
environment. No response is required.

Challenges to Underlying TSCA Sec.  5(a)(3) Determinations

    Comment 1: EPA received multiple comments regarding the manner in
which these proposed Significant New Use Rules (SNURs) operate. One
comment requested that, in light of alleged legal and factual
deficiencies, EPA withdraw both the proposed SNURs and the underlying
``not likely'' determinations and instead issue determinations, section
5(e) orders, and post-order section 5(f) SNURs based on a finding that
the chemical substances ``may present an unreasonable risk to health or
the environment'' under section 5(a)(3)(B). Another comment stated that
EPA may not rely on ``non-5(e) SNURs'' to make a ``not likely'' finding
under section 5(a)(3)(C) and has failed to provide a legal and factual
basis for its determination as required by section 5(g), but
nevertheless supports the need to promulgate these SNURs at this time
because otherwise there will be no protections at all in place for
these chemical substances. The commenter stated that EPA found risks to
workers for a number of the chemical substances subject to these
proposed SNURs, absent protective measures that EPA expects will be
implemented and will provide sufficient protection, and that EPA's risk
determination for these chemicals should not assume there will be full
compliance with all of the controls recommended in an associated Safety
Data Sheet and that such compliance would be adequate to protect
workers.
    Response: These comments constitute challenges to certain TSCA
Sec.  5(a)(3) determinations rather than to the basis for or the
content of the SNURs, which EPA has promulgated using its discretion to
issue SNURs under TSCA Sec.  5(a)(2). Because these comments are not
germane to this rulemaking, EPA is not responding to these comments in
this notice and declines to withdraw the SNURs on the basis of these
comments. Regardless, EPA has already defended the legal and factual
basis for the TSCA Sec.  5(a)(3) determinations that these comments
reference in a prior legal challenge. See Brief of U.S. Environmental
Protection Agency in NRDC v. USEPA, 2d Cir. Docket No. 18-25.

Regulation of Workplace Risks

    Comment 2: Several commenters argued that where EPA finds
unreasonable risks to workers in the absence of certain protective
measures (e.g., personal protective equipment, engineering controls,
etc.), EPA must identify as a significant new use any use of the
chemical that occurs without those protections. Specifically, the
commenters stated that, where EPA finds unreasonable risk to workers
absent certain protective measures, the Agency must issue an order to
address workplace risks--as well as consider promulgating a significant
new use rule--because in these circumstances ``the manufacture,
processing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk

factors, including an unreasonable risk to a potentially exposed
subpopulation.'' 15 U.S.C. 2604(e)(1)(A)(ii)(I). In following, the
commenters state EPA ``shall issue an order . . . to prohibit or limit
the manufacture, processing, distribution in commerce, use, or disposal
of such substance or to prohibit or limit any combination of such
activities to the extent necessary to protect against an unreasonable
risk of injury to health or the environment.'' Id. Sec.  2604(e)(1)(A).
After issuing that order, EPA must consider whether to promulgate a
significant new use rule ``that identifies as a significant new use any
manufacturing, processing, use, distribution in commerce, or disposal
of the chemical substance that does not conform to the restrictions
imposed by the * * * order'' or publish a statement justifying the
decision not to promulgate the SNUR. 15 U.S.C. 2604(f)(4). According to
the commenters, Congress spoke clearly and required EPA to regulate
unreasonable risks that a chemical substance ``may present'' under
TSCA. The commenters contend that nothing in the text of TSCA allows
EPA to simply assume that sufficient protective measures will be
implemented to eliminate potential unreasonable risks; such an
assumption essentially negates TSCA Sec.  5(e), which could not be
Congress's intention. And, the commenters claim, EPA cannot find that a
chemical is not likely to present an unreasonable risk based solely on
EPA's unjustified ``expectation'' that sufficient protective measures
will be implemented . . . EPA effectively found risks to workers for
several chemical substances subject to these proposed SNURs, absent
protective measures that EPA simply ``expects'' will be implemented and
will provide sufficient protection. Commenters assert that EPA's risk
determination for these chemicals should not assume there will be full
compliance with all of the controls recommended in an associated Safety
Data Sheet and that such compliance would be adequate to protect
workers. Because EPA relied on these protective measures in its
analysis of risk, commenters state that EPA should identify any
condition of use without these protective measures to be a significant
new use, meriting advance notification to EPA.
    Response: To the extent these comments argue that the Agency should
have issued orders under Section 5(e) or 5(f) of TSCA, EPA believes
they are beyond the scope of the SNUR for which EPA is specifically
soliciting comments and are properly directed to the Section 5(a)(3)
determinations that pertain to the underlying PMNs for the SNUR. EPA is
therefore not responding to these comments here. However, EPA is
responding to comments that pertain specifically to the SNUR, i.e.,
those regarding the uses that should be subject to the SNUR, as well as
the assertion that EPA must include certain worker protection
provisions in the SNURs on the basis of TSCA Section 5(f)(4).
    EPA disagrees with the comment that, with respect to scenarios
where EPA expects that worker protection requirements under other
federal/state authorities would mitigate risks to workers, EPA must
designate all uses without those protections as ``significant new
uses''. Section 5(a)(2) of TSCA does not mandate that any specific uses
be designated as significant. Instead, EPA has discretion as to which
new uses to designate as significant. As mentioned in the ``not
likely'' determination documents for the subject PMNs in this batch
SNUR (see https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely), in
exercising its discretion regarding which new uses should be designated
as significant under section 5(a)(2), EPA expects compliance with
federal and state laws, such as worker protection standards or disposal
restrictions, unless case-specific facts indicate otherwise. Further,
any workplace risks will be mitigated if exposures are appropriately
controlled, and EPA expects that employers will require and workers
will use the appropriate controls (e.g., personal protective equipment
such as impervious gloves and/or respirators), consistent with the
Safety Data Sheet prepared by the PMN submitter, in a manner adequate
to protect them.
    With respect to comments regarding TSCA Section 5(f)(4), EPA notes
that because no applicable TSCA Section 5(e) or 5(f) orders have been
issued, the requirements of TSCA Section 5(f)(4) are not triggered.
Therefore, EPA need not make changes in the proposed SNUR to correspond
to Section 5(e) and 5(f) orders that have not been issued.

SNURs Lack Provisions To Notify Downstream Processors and Users of
Agency Concerns

    Comment 3: One commenter suggested that the proposed SNURs lack
notification requirements for worker protection and hazard
communication programs to ensure that risks to workers and the public
from downstream activities are identified and addressed and fail to
provide notice to downstream processors and users of the PMN
substance's environmental effects and EPA's required limits on release
to water.
    Response: 40 CFR 721.5 requires manufacturers and processors to
either file a SNUN before distributing the chemical substance in
commerce or notify downstream customers of the existence of a SNUR on a
particular chemical substance (or determine that such users have
notice). Thus, one of two possibilities will occur: (1) Downstream
customers do receive notice of the SNUR, or (2) notification of
downstream uses becomes unnecessary because the manufacturer or
processors submits a SNUN to EPA, and the Agency either determines that
such manufacture and processing is not likely to present unreasonable
risk, or takes appropriate regulatory action to address the risks.

Impact on Downstream Users

    Comment 4: One commenter similarly identified impacts of SNURs on
downstream users who ``often must struggle to figure out when a product
they use is covered by a SNUR,'' particularly when the proposed SNUR
provides only the generic name of a confidential chemical substance, or
when the proposed SNUR covers the use of a chemical substance in an
article. The comment also notes that the burden and compliance risks
are greatest when the proposed SNUR contains reporting requirements.
The commenter indicates that downstream users may depend on voluntary
disclosure by the supplier or a downstream formulator/distributor, in
contrast to the mandatory reporting requirements in place under a 5(e)
order. The comment concludes that EPA should take steps to close the
gap between proposal and finalization of SNURs by finalizing SNURs
expeditiously, by notifying submitters of EPA's likelihood of
promulgating a SNUR, and by requesting companies alert downstream users
of impending SNURs.
    Response: The Agency is aware of the impacts of the issuance of a
SNUR, including and beyond those specific to the actual TSCA
notification requirement. EPA's focus is to take appropriate action
under TSCA to control potential risks to human health or the
environment from exposure or release of a new chemical, including
requiring notification of potential significant new uses.

CBI and Disclosure of Health and Safety Information

    Comment 5: EPA received multiple comments critical of EPA's process
in promulgating the proposed SNURs. One

comment requested that EPA extend the comment period and make CBI
available for review with appropriate safeguards to avoid depriving the
public of a meaningful opportunity to participate. The commenter stated
that TSCA does not extend CBI protection to any health and safety study
which is submitted under TSCA, including underlying information and
occupational exposure studies. In addition to the scientific analyses
developed by EPA (e.g., engineering reports, Structure Activity Team
reports), which fall under this definition, other information that is
generally required to be submitted with PMNs, such as toxicity studies,
information on worker exposure, and the majority of information in
Safety Data Sheets, also fall under this definition. EPA must disclose
this information to the public. Despite these mandates, the commenter
argues that EPA has failed to disclose this health and safety
information. The comment states that EPA's SAT reports, engineering
reports, and exposure reports all constitute or contain health and
safety information that EPA must disclose, yet for P-16-575 (as an
example provided by the commenter) EPA has largely redacted these
documents.
    Response: EPA recognizes that TSCA Section 14 does not protect from
disclosure certain confidential information described in Section 14(b),
including health and safety information. However, Section 14 does not
require that EPA make a final confidentiality determination for all
information submitted under TSCA and claimed as CBI as part of a PMN
review, and EPA has not made a determination regarding the eligibility
for confidential treatment of the information referenced in the
comment. Here, EPA balanced the need for sufficient information in the
public record to fully explain the bases for its decisions with the
protections for CBI in section 14. With regard to EPA technical support
reports underlying the section 5 determination, they are not covered by
section 14(b)(2), which specifically refers to health and safety
studies submitted to EPA. EPA provided sufficient information in the
public record to fully explain the bases for its decisions while
preserving the submitter's confidentiality claims through generally
accepted means, including the aggregation of certain data in the public
docket, presentation of ranges of values, or masking of manufacturing
site locations to prevent CBI disclosure.

Identifying ``Significant New Uses'' for SNURs

    Comment 6: The commenter considers the approach taken for these
proposed SNURs that found ``not likely to present an unreasonable
risk'' under the conditions of use described in the PMNs to be
generally consistent with the requirements of the 2016 amendments to
TSCA. To the extent that this approach also represents potential
improvements in the Agency's ability to provide more timely review of
PMNs, the commenter supports the approach. The commenter encourages EPA
to take a risk-based approach--with particular focus on changes
occurring in the conditions of use of a substance that can affect
exposure (i.e., human exposure and environmental releases)--in
identifying what changes in the conditions of use that will constitute
significant new uses, and to consider the potential burden on
downstream users when designating potential new uses to be significant.
The commenter further encouraged EPA to use its discretion to consider
``all relevant factors,'' including the cost of submitting SNUNs, the
burden of compliance with SNUR reporting requirements such as Chemical
Data Reporting (CDR) and TSCA section 12(b) export notification
reporting, and the compliance risk caused by vague regulations, in
promulgating 5(a)(2) SNURs to minimize regulatory burdens on downstream
users.
    Response: EPA agrees that it should--and does--identify significant
new uses only after consideration of the ``relevant factors''
identified in TSCA section (a)(2) ((1) the ``projected manufacturing or
processing volume of a chemical substance''; (2) the ``type or form of
exposure of human beings or the environment'' to the chemical
substance; (3) the ``magnitude and duration of exposure of human beings
or the environment'' to the environment; and (4) the ``reasonably
anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal'' of the chemical substance).
However, the Agency typically does not have all of the data specific
enough for each of the aforementioned factors to support risk
assessment(s) for anticipated changes that are not part of the PMN.
Hence, such information would be provided if and when a SNUN is
submitted that would provide such information for the significant new
use. Another commenter supported this approach, explaining that future
risks not contemplated in the PMN will be addressed by analysis of a
significant new use notice (SNUN) which streamlines the current system
which typically runs much longer than 90 days proscribed in TSCA. As to
other regulatory requirements such as CDR or export notification, the
Agency understands the impact and coordinates with those programs to
eliminate inefficiencies. Furthermore, the Agency flags chemical
substances on the TSCA Inventory that are regulated with a SNUR. For
interpretation of SNUR notification requirements, the regulated
community is encouraged to contact the Agency by using the options
outlined in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections
of the SNUR preamble.

Catch-All Significant New ``Use''

    Comment 7: One commenter suggested that EPA should generally
designate as a significant new use any use of a chemical substance
other than the uses EPA evaluated in its PMN review and determined are
not likely to present an unreasonable risk. In particular, the
commenter identified P-16-192, P-16-380-385, and 16-575, as SNURs for
which other types of triggers for notification (e.g., manufacture in a
certain physical form, or manufacture, processing, or use to result in
inhalation exposure) were used. Although the commenter supports
inclusion of these triggers, it comments that EPA must also require
notification for use other than that which EPA has reviewed.
    Response: Commenters suggested approach is overly broad. TSCA
requires that EPA evaluate new chemicals under their conditions of use,
including the intended, known and reasonably foreseen circumstances of
manufacture, processing, distribution in commerce, use and disposal.
Based upon EPA's review of the relevant PMNs, the Agency identified
uses that are appropriate for designation as ``significant new uses''
in order to ensure that EPA has an opportunity to review those uses in
a SNUN submission at a later date and address any unreasonable risks at
that time. TSCA Sec.  5(a)(2) does not require EPA to take the catch-
all approach advocated by commenters, and EPA believes a more tailored
approach is warranted to avoid unduly burdensome regulations.

Being More Specific in 40 CFR 721.80

    Comment 8: One commenter suggested that EPA must clearly specify
the cross references to EPA's general regulations in the SNURs. A
number of proposed SNURs state that the significant new uses are
``requirements as specified in 721.80.'' Since 40 CFR 721.80 contains
25 possible significant

new use designations, this is misleading.
    Response: The Agency understands the confusion. Where one of the 25
specific significant new use designations in 721.80 is not being used,
in the interest of transparency and clarity, the Agency generally lists
``Industrial, commercial, and consumer activities. Requirements as
specified in Sec.  721.80'' and follows with a complete sentence
describing the actual activity. EPA will modify its approach so that
where it is not citing a specific designation in 721.80, the Agency
will drop the phrase ``Requirements as specified in Sec.  721.80.'' For
example, the SNUR at 40 CFR 721.11182 is finalized simply as:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance other than in an
amorphous form.
    In response to this comment, the Agency is making a similar change
to these 721.80 designations in all the final SNURs in this batch rule,
except the SNURs at 721.11190 and 721.11191. Those two SNURs
specifically cite 721.80(j), which is the confidential use identified
in the associated PMN submission for those SNURs.

Regulatory Burden of SNURs for Safer Chemicals

    Comment 9: One comment was regarding an enzyme used in the
polymerization of glucose that would be subject to a proposed SNUR due
to concerns with respiratory sensitization. The commenter stated that
enzymes are recognized to have a positive and sustainable environmental
profile and inherently low toxicity compared to other chemicals, and
that this SNUR is a signal that it will be significantly more
challenging to bring new enzymes to market and may decrease innovation
that can address global challenges as highlighted by the UN Sustainable
Development Goals. The commenter additionally voiced concern for the
lengthy review time for PMN submissions.
    Response: To the extent commenter is disputing the outcome of a PMN
review, these comments are more properly directed to the specific PMN
determination and not this SNUR rulemaking. As mentioned previously in
the response to Comment 1, this comment constitutes challenges to the
corresponding TSCA Sec.  5(a)(3) determinations rather than to the
basis for or the content of the SNURs, which EPA has promulgated using
its discretion to issue SNURs under TSCA Sec.  5(a)(2). Nonetheless,
the Agency is aware of, and working to remedy, the increased length of
time it has been taking to review and reach decision on section 5
notices as it implements the amendments to TSCA.

Non-Animal Testing

    Comment 10: One commenter supports this approach of addressing
potential risks that the subject chemicals may present under reasonably
foreseen conditions of use, while finding that under the intended
conditions of use, they are not likely to present unreasonable risks.
In contrast, the commenter states, in its early implementation of the
amended TSCA, EPA addressed such potential risks in consent agreements
with PMN submitters. In these cases, the commenter notes, EPA
frequently required health and ecotoxicity testing, including hundreds
of vertebrate animal tests requiring tens of thousands of animals. The
commenter therefore supports EPA's new approach, which is consistent
with TSCA's requirements to reduce and replace the use of vertebrate
animals in the testing of chemical substances and promote the
development and timely incorporation of new test methods and strategies
that are not based on vertebrate animals. In addition, it protects
human health and the environment by addressing potential risks when the
conditions of use under which they arise are intended, either as
identified in PMNs or in SNUNs, while reducing the burden on PMN
submitters and streamlining the review process.
    Response: As mentioned in the preamble to this SNUR, any
recommendation for information identified by EPA was made based on
EPA's consideration of available screening-level data, if any, as well
as other available information on appropriate testing for the chemical
substance. Further, any such testing identified by EPA that includes
testing on vertebrates was made after consideration of available
toxicity information, computational toxicology and bioinformatics, and
high-throughput screening methods and their prediction models. EPA also
recognizes that whether testing/further information is needed will
depend on the specific exposure and use scenario in the SNUN. EPA
encourages all SNUN submitters to contact EPA to discuss any potential
future testing. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing in vertebrate animals, EPA encourages
consultation with the Agency on the use of alternative test methods and
strategies (also called New Approach Methodologies, or NAMs), if
available, to generate the recommended test data. EPA encourages dialog
with Agency representatives to help determine how best the submitter
can meet both the data needs and the objective of TSCA section 4(h).

Do Not Use SNURs as Information Gathering Tool, Tracking Tool

    Comment 11: One commenter urged EPA to not rely on SNURs as tools
for tracking use and production of chemical or for otherwise gathering
potentially useful information, but instead suggested that EPA rely on
provisions like section 8 which specifically authorize such acts.
    Response: EPA is not issuing a requirement to develop any data or
information as a result of these SNURs. It is the responsibility of a
SNUN submitter to provide any such information as required by TSCA
section 5 and SNUN regulations at 40 CFR part 721. Regarding
potentially useful information, EPA encourages all SNUN submitters to
contact EPA to discuss any potential future testing. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping
requirements for 13 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information

identified by EPA was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the chemical substance. Further, any such
testing identified by EPA that includes testing on vertebrates was made
after consideration of available toxicity information, computational
toxicology and bioinformatics, and high-throughput screening methods
and their prediction models. EPA also recognizes that whether testing/
further information is needed will depend on the specific exposure and
use scenario in the SNUN. EPA encourages all SNUN submitters to contact
EPA to discuss any potential future testing. See Unit VIII. for more
information.
     CFR citation assigned in the regulatory text section of
these rules.
    The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.
    The chemical substances that are the subject of these SNURs
completed premanufacture review. EPA has initially determined under
TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from
the conditions of use described in the PMNs could result in changes in
the type or form of exposure to the chemical substances and/or
increased exposures to the chemical substances and/or changes in the
reasonably anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of the chemical substances.
Consequently, EPA is designating these changes as significant new uses.

PMN Number: P-16-192

    Chemical Name: Silanized amorphous silica (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a reinforcing filler for the production of rubber goods. Based on
test data for crystalline silica, EPA identified concerns for lung
effects if the chemical substance is not used following the limitations
noted below. The conditions of use of the PMN substance as described in
the PMN include the following protective measures:
    Manufacture of the PMN substance in an amorphous form.
    The SNUR designates as a ``significant new use'' the absence of
this protective measure.
    Potentially useful information: EPA has determined that certain
information about the physical-chemical properties of the PMN substance
may be potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use designated by this SNUR.
EPA has determined that information about the physical form, particle
size, and water solubility would help characterize the potential health
effects of the PMN substance.
    CFR citation: 40 CFR 721.11182.

PMN Numbers: P-16-354 and P-16-355

    Chemical name: Esteramine (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a chemical intermediate.
Based on the physical/chemical properties of the PMN substances and
Structure Analysis Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for irritation and
developmental/reproductive toxicity, and aquatic toxicity at surface
water concentrations exceeding 1 part per billion (ppb), if the
chemical substances are not used following the limitations noted below.
The conditions of use of the PMN substances as described in the PMNs
include the following protective measures:
    1. No release of a manufacturing, processing, or use stream
associated with any use of the substances, other than the confidential
chemical intermediate use described in the PMNs, into the waters of the
United States exceeding a surface water concentration of 1 ppb; and
    2. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the aquatic and human health toxicity of the PMN
substances may be potentially useful to characterize the health and
environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
designated by this SNUR. EPA has determined that the results of
specific organ toxicity and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substances.
    CFR citation: 40 CFR 721.11183.

PMN Numbers: P-16-380, P-16-381, P-16-382, P-16-383, P-16-384, and P-
16-385

    Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-381), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-382), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-384), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-385).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a component of an
electrocoat resin. Based on the physical/chemical properties of the PMN
substances and test data on analogous substances, EPA has identified
concerns for lung effects and toxicity to aquatic organisms at
concentrations that exceed 16 ppb if the chemical substances are not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:

    1. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances; and
    2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 16 ppb.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substances may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
this SNUR. EPA has determined that the results of specific target
organ, pulmonary, and acute aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substances.
    CFR citation: 40 CFR 721.11184 (P-16-380); 40 CFR 721.11185 (P-16-
381); 40 CFR 721.11186 (P-16-382); 40 CFR 721.11187 (P-16-383); 40 CFR
721.11188 (P-16-384); and 40 CFR 721.11189 (P-16-385).

PMN Numbers: P-16-483 and P-16-484

    Chemical names: Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic) (P-16-483) and Inorganic acids, metal salts,
compds. with substituted aromatic heterocycle, (generic) (P-16-484).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of P-16-483 will be as a plastic additive and the
generic (non-confidential) use of P-16-484 will be as a chemical
intermediate. Based on test data submitted on P-16-483 and data for
analogous compounds, EPA has identified concerns for irritation,
specific organ effects, and aquatic toxicity if the chemical is not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:
    1. No use of the substances other than the confidential use
described in the PMNs;
    2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 34 ppb; and
    3. No manufacturing, processing or use of the PMN substances
without the engineering controls described in the PMNs to limit
exposure to dust.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substances may be potentially useful to characterize the effects of
the PMN substances if a manufacturer or processor is considering
submitting a SNUN for a significant new use designated by this SNUR.
EPA has determined that the results of aquatic toxicity and specific
organ toxicity and aquatic toxicity testing would help characterize the
potential health and environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.11190
(P-16-683) and 40 CFR 721.11191
(P-16-684).

PMN Number: P-16-575

    Chemical name: Glucosyltransferase. International Union of
Biochemistry and Molecular Biology Number: <IP_ADDRESS>.
    CAS number: 9032-14-8.
    Basis for action: The PMN states that the use of the substance will
be for polymerization of glucose. Based on the allergenic properties of
proteins and review of surrogate enzymatic protein data submitted, EPA
has identified concerns for respiratory sensitization if the chemical
is not used following the limitations noted below. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
    No manufacture, processing, or use of the PMN substance that
results in inhalation exposures to the substance.
    The SNUR designates as a ``significant new use'' the absence of
this protective measure.
    Potentially useful information: EPA has determined that certain
information about the workplace exposure to the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by this SNUR. EPA has
determined that the results of workplace air monitoring would help
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11192.

PMN Number: P-16-581

    Chemical name: Alpha 1,3-polysaccharide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance
will be as a polymer additive, paper coating component, composite
component, and fiber additive. Based on analogy to high molecular
weight polymers, EPA has identified concerns for lung effects if the
chemical is not used following the limitations noted below. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No use of the substance other than the uses described in the
PMN; and
    2. No manufacture, processing, or use with particle size less than
10 micrometers.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health effects of the PMN substance if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by this SNUR. EPA has determined that
the results of pulmonary effects toxicity testing of the PMN substance
may be potentially useful in characterizing the health effects of the
PMN substance.
    CFR citation: 40 CFR 721.11193.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are the subject of these SNURs and as further discussed in Unit
IV, EPA identified certain reasonably foreseen conditions of use and
other circumstances different from the intended conditions of use
identified in the PMNs and determined that those changes could result
in changes in the type or form of exposure to the chemical substances
and/or increased exposures to the chemical substances and/or changes in
the reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of the chemical
substances.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a

listed chemical substance for the described significant new use.
     EPA is obligated to make a determination under TSCA
section 5(a)(3) regarding the use described in the SNUN, under the
conditions of use. The Agency will either determine under section
5(a)(3)(C) that the significant new use is not likely to present an
unreasonable risk, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use, or make a determination
under section 5(a)(3)(A) or (B) and take the required regulatory action
associated with the determination, before manufacture or processing for
the significant new use of the chemical substance can occur.
     EPA will identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to the restrictions imposed by the underlying
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
    EPA designated October 9, 2018 (the date of web posting of the
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach has been to ensure that a
person could not defeat a SNUR by initiating a significant new use
before the effective date of the final rule.
    In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of October 9, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, that person would have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information 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
potentially useful information for all SNURs listed here. Descriptions
are provided for informational purposes. The potentially useful
information identified in Unit IV. will be useful to EPA's evaluation
in the event that someone submits a SNUN for the significant new use.
Companies who are considering submitting a SNUN are encouraged, but not
required, to develop the information on the substance, which may assist
with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). 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.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at Sec.
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not

met. In the case of a production volume trigger, this means that the
aggregate annual production volume does not exceed that identified in
the bona fide submission to EPA. Because of confidentiality concerns,
EPA does not typically disclose the actual production volume that
constitutes the use trigger. Thus, if the person later intends to
exceed that volume, a new bona fide submission would be necessary to
determine whether that higher volume would be a significant new use.

X. SNUN Submissions

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

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2017-0366.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances
that were the subject of PMNs and TSCA section 5(e) consent orders. 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 action. 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)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all
information currently available to EPA, it appears that no small or
large entities presently engage in such activities. A SNUR requires
that any person who intends to engage in such activity in the future
must first notify EPA by submitting a SNUN. Although some small
entities may decide to pursue a significant new use in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemicals, the Agency receives only a small
number of notices per year. For example, the number of SNUNs received
was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in
FY2015, 10 in FY2016, and 14 in FY2017, and only a fraction of these
were from small businesses. In addition, the Agency currently offers
relief to qualifying small businesses by reducing the SNUN submission
fee from $16,000 to $2,800. This lower fee reduces the total reporting
and recordkeeping of cost of submitting a SNUN to about $10,116 for
qualifying small firms. Therefore, the potential economic impacts of
complying with this SNUR are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities, which was provided to the Chief
Counsel for Advocacy of the Small Business Administration.

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

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this action.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: March 27, 2019.
Tala Henry,
Acting Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

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

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

Sec.  9.1   OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances.............................
------------------------------------------------------------------------

                                * * * * *
721.11182...............................................       2070-0012
721.11183...............................................       2070-0012
721.11184...............................................       2070-0012
721.11185...............................................       2070-0012
721.11186...............................................       2070-0012
721.11187...............................................       2070-0012
721.11188...............................................       2070-0012
721.11189...............................................       2070-0012
721.11190...............................................       2070-0012
721.11191...............................................       2070-0012
721.11192...............................................       2070-0012
721.11193...............................................       2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec. Sec.  721.11182 through 721.11193 to subpart E to read as
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11182 Silanized amorphous silica (generic).
721.11183 Esteramine (generic).
721.11184 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).
721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol
A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
721.11186 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts),
(generic).
721.11187 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).
721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol
A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
721.11189 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts),
(generic).
721.11190 Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic).

721.11191 Inorganic acids, metal salts, compds. with substituted
aromatic heterocycle, (generic).
721.11192 Glucosyltransferase, International Union of Biochemistry
and Molecular Biology Number: <IP_ADDRESS>.
721.11193 Alpha 1,3-polysaccharide (generic).

Sec.  721.11182   Silanized amorphous silica (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
silanized amorphous silica (P-16-192) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance other than in an
amorphous form.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11183   Esteramine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
esteramine (PMN P-16-354 and P-16-355) are subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substances in
any manner that results in inhalation exposure. It is a significant new
use to release a manufacturing, processing, or use stream associated
with any use of the substances, other than the confidential chemical
intermediate use described in the premanufacture notices, into the
waters of the United States exceeding a surface water concentration of
1 part per billion (ppb) using the methods described in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (e), and (i) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11184  Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as formic
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
acetates (salts), (P-16-380) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11185   Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically as propanoic acid, 2-
hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
formates (salts), (P-16-381) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.1118  6 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as formic
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
sulfamates (salts), (P-16-382) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in

Sec.  721.125(a) through (c), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11187   Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as formic
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
acetates (salts), (P-16-383) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11188   Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (P-16-384) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11189   Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as formic
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
sulfamates (salts), (P-16-385) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11190   Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
inorganic acids, metal salts, compds. with modified heteroaromatics,
(PMN P-16-483) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the premanufacture notice to limit exposure to
dust.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=34.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11191   Inorganic acids, metal salts, compds. with
substituted aromatic heterocycle, (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
inorganic acids, metal salts, compds. with substituted aromatic
heterocycle, (PMN P-16-484) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the

premanufacture to limit exposure to dust.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=34.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11192   Glucosyltransferase, International Union of
Biochemistry and Molecular Biology Number: <IP_ADDRESS>.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
glucosyltransferase, International Union of Biochemistry and Molecular
Biology Number: <IP_ADDRESS> (PMN P-16-575, CAS No. 9032-14-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11193   Alpha 1,3-polysaccharide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alpha
1,3-polysaccharide (generic) (PMN P-16-581) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a polymer
additive, paper coating component, composite component, or fiber
additive. It is a significant new use to manufacture, process or use
the PMN substance with particle size less than 10 micrometers.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2019-06624 Filed 4-4-19; 8:45 am]
 BILLING CODE 6560-50-P