[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66599-66612]
[FR Doc No: 2019-26224]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0697; FRL-10002-30]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (18-4)

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 chemical substances that are
the subject of premanufacture notices (PMNs), and TSCA Orders. The
SNURs require persons who intend to manufacture (defined by statute to
include import) or process any of these chemical substances for an
activity that is designated as a significant new use by this rule to
notify EPA at least 90 days before commencing that activity. 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
by that determination.

DATES: This rule is effective on February 3, 2020. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
December 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_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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
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 January 6, 2020
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.

B. How can I access the docket?

    The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by the docket identification (ID) number listed at the top
of this document, is available at http://www.regulations.gov or at the
Office of Pollution Prevention and

Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 29
chemical substances that are the subject of PMNs. 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.
    In the Federal Register of March 19, 2019 (84 FR 99996) (FRL-9986-
83), EPA proposed a SNUR for these 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 for the proposed rule.
    The record for the SNUR was established in the docket under docket
ID number EPA-HQ-OPPT-2018-0697. That docket includes information
considered by the Agency in developing the proposed and final rules,
public comments submitted for the rule, and EPA's responses to public
comments received on the proposed rule.

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

    TSCA section 5(a)(2) (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 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, and taken such
actions as are required in association with that determination (15
U.S.C. 2604(a)(1)(B)(ii)). In the case of a determination other than
not likely to present unreasonable risk, the applicable review period
must also expire before manufacturing or processing for the new use may
commence.

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 40 CFR 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). These requirements include the
information submission requirements of TSCA sections 5(b) and 5(d)(1),
the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the use is not likely to present
an unreasonable risk of injury under the conditions of use for the
chemical substance or take such regulatory action as is associated with
an alternative determination before the manufacture or processing for
the significant new use can commence. In the case of a determination
other than not likely to present unreasonable risk, the applicable
review period must also expire before manufacturing or processing for
the new use may commence. If EPA determines that the 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

    When the Agency issues an Order under TSCA section 5(e), TSCA
section 5(f)(4) requires that the Agency consider whether to promulgate
a SNUR for any use not conforming to the restrictions of the Order or
publish a statement describing the reasons for not initiating the
rulemaking. TSCA section 5(a)(2) 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 determining 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 TSCA section 5(a)(2) factors listed in this
unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from seven entities on the proposed
rule. The Agency's responses are described in a separate Response to
Public Comments document contained in the public docket for this rule,
EPA-HQ-OPPT-2018-0697. As described in the Response to Public Comments
document, EPA is finalizing the SNURs as proposed, as the only changes
were correcting some CFR citations in the regulatory text.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping
requirements for these chemical substances in 40 CFR part 721, subpart
E. In Unit IV. of the proposed rule (84 FR 9999; March 19, 2019), 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 TSCA section 5(e) Order.
     Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the TSCA Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.

     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
    These PMN chemical substances are subject to Orders under TSCA
section 5(e)(1)(A)(ii)(I) where EPA determined that activities
associated with the PMN substances may present unreasonable risk to
human health or the environment. Those Orders require protective
measures to limit exposures or otherwise mitigate the potential
unreasonable risk. The SNURs 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).
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) Order usually requires that
potentially exposed employees wear specified respirators unless actual
measurements of the workplace air show that air-borne concentrations of
the PMN substance are below the New Chemical Exposure Limit (NCEL). The
comprehensive NCELs provisions in TSCA section 5(e) Orders include
requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR
part 721, subpart B, for SNURs. Therefore, for these cases, the
individual SNURs in 40 CFR part 721, subpart E, will state that persons
subject to the SNUR who wish to pursue NCELs as an alternative to the
40 CFR 721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use
the NCELs approach for SNURs that are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) Order.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that regulation was
warranted under TSCA section 5(e), pending the development of
information sufficient to make reasoned evaluations of the health or
environmental effects of the chemical substances. The basis for such
findings is outlined in Unit IV. Based on these findings, TSCA section
5(e) Orders requiring the use of appropriate exposure controls were
negotiated with the PMN submitters. As a general matter, EPA believes
it is necessary to follow TSCA section 5(e) Orders with a SNUR that
identifies the absence of those protective measures as Significant New
Uses to ensure that all manufacturers and processors--not just the
original submitter--are held to the same standard.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To 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).
     To 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.
     To 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.
     To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
    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.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) Orders have been issued
for all the chemical substances, and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from undertaking activities which will
be designated as significant new uses. The identities of 23 of the 29
chemical substances subject to this rule have been claimed as
confidential. Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this rule are ongoing.
    Furthermore, EPA designated August 27, 2018 (the date of public
release of the original direct final and proposed rules) 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 August 27, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons will 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 developing 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 (40 CFR 720.50).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing, under 40 CFR part 721, subpart E. In Unit
IV. of the original proposed rule (84 FR 9999; March 19, 2019), lists
potentially useful information to EPA's evaluation.
    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.
Furthermore, pursuant to TSCA section 4(h), which pertains to reduction
of testing on 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).
    In some of the TSCA section 5(e) Orders for the chemical substances
regulated under this rule, EPA has established production volume
limits. These limits cannot be exceeded unless the PMN submitter
submits the results of specified tests. The SNURs contain the same
production volume limits as the TSCA section 5(e) Orders. Exceeding
these production limits is defined as a significant new use. Persons
who intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described
in the TSCA Orders 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 PMN substances. Further, any such testing
request on the part of 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.
    The potentially useful information identified in Unit IV. of the
original proposed rule may not be the only means of addressing the
potential risks of the chemical substance. However, submitting a SNUN
without any test data or other information may increase the likelihood
that EPA will take action under TSCA sections 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 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 40 CFR
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 40 CFR
721.1725(b)(1) with that under 40 CFR 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 40 CFR 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 40 CFR 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-2018-0697.

XII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This action establishes SNURs for several new chemical substances
that were the subject of PMNs and TSCA section 5(e) Orders. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the 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 the 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 activities in this action have already
been approved by OMB pursuant to the 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 using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (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 RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this SNUR will 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. 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, 14 in FY2017, and 18 in FY2018
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: Federalism

    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 (64 FR 43255,
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    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 (65 FR 67249, November 9, 2000), do not apply
to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (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: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (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: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

XIII. Congressional Review Act (CRA)

    Pursuant to the CRA (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: November 26, 2019.
Tala Henry,
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 entries for Sec. Sec.  721.11221 through 721.11246
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
------------------------------------------------------------------------

                                * * * * *
721.11221...............................................       2070-0012
721.11222...............................................       2070-0012
721.11223...............................................       2070-0012
721.11224...............................................       2070-0012
721.11225...............................................       2070-0012
721.11226...............................................       2070-0012
721.11227...............................................       2070-0012
721.11228...............................................       2070-0012
721.11229...............................................       2070-0012
721.11230...............................................       2070-0012
721.11231...............................................       2070-0012
721.11232...............................................       2070-0012
721.11233...............................................       2070-0012
721.11234...............................................       2070-0012
721.11235...............................................       2070-0012
721.11236...............................................       2070-0012
721.11237...............................................       2070-0012
721.11238...............................................       2070-0012
721.11239...............................................       2070-0012
721.11240...............................................       2070-0012
721.11241...............................................       2070-0012
721.11242...............................................       2070-0012
721.11243...............................................       2070-0012
721.11244...............................................       2070-0012
721.11245...............................................       2070-0012
721.11246...............................................       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.  721.11221 through 721.11246 to subpart E to read as
follows:

Subpart E Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11221 Fatty acids, C16 and C18-unsatd., Me esters, chlorinated.
721.11222 Chlorinated complex esters (generic).
721.11223 Sodium branched chain alkyl hydroxyl and branched chain
alkenyl sulfonates (generic).
721.11224 Spiro tetrafluoroborate (generic).
721.11225 2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.
721.11226 2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-
methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride (1:1).
721.11227 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.
721.11228 Aliphatic polyamines, polymers with bisphenol A and
epichlorohydrin (generic).
721.11229 Epoxy-amine adduct, methanesulfonates (generic).
721.11230 Modified ethylene-vinyl alcohol copolymer (generic).
721.11231 Cashew, nutshell liq., polymer with acid and halohydrin
(generic).
721.11232 Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic).
721.11233 Cashew nut shell liquid, branched polyester-polyether
polyol (generic).
721.11234 Methylene diphenyl diisocyanate terminated polyurethane
resin (generic).
721.11235 2-Furancarboxylic acid, tetrahydro-.
721.11236 Heteromonocycle, homopolymer, alkyl substituted carbamate,
alkyl ester (generic).
721.11237 Polysiloxanes, di alkyl, substituted alkyl group
terminated, alkoxylated, reaction products with alkanoic acid,
isocyanate substituted-alkyl carbomonocycle and polyol (generic).
721.11238 Substituted carbomonocycle, polymer with substituted
heteromonocycle and substituted polyalkylene glycol (generic).
721.11239 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid,
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl
substituted carbomonocycle and alkyl substituted alkanediol
(generic).
721.11240 Substituted carbomonocycle, polymer with
diisocyanatoalkane, substituted alkylacrylate blocked (generic).
721.11241 1,2-Ethanediol, 1,2-dibenzoate.
721.11242 Alkenoic acid, reaction products with
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with
isocyanatoalkane and substituted alkanoic acid, substituted
monoacrylate alkanoate-blocked (generic).
721.11243 Aromatic dicarboxylic acid, compound with alkane diamines,
polymer with alkane diamine and dicarboxylic acid (generic).
721.11244 Aromatic dicarboxylic acid, compound with alkyl diamines,
homopolymer (generic).
721.11245 Aspartic acid, tallow modified diester (generic).
721.11246 Substituted alkanediol, polymer with heteromonocycles,
alkenoate, metal complexes (generic).
* * * * *

Sec.  721.11221  Fatty acids, C16 and C18-unsatd., Me esters,
chlorinated.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids, C16
and C18-unsatd., Me esters, chlorinated (PMN P-15-353, CAS No. 1642303-
17-0) 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(k). It is a significant new use to
manufacture the substance beyond three years.
    (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.
    (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.  721.11222  Chlorinated complex esters (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
chlorinated complex esters (PMN P-15-433) 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(k). It is a significant new use to
manufacture the substance beyond three years.
    (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.
    (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.  721.11223  Sodium branched chain alkyl hydroxyl and branched
chain alkenyl sulfonates (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as sodium
branched chain alkyl hydroxyl and branched chain alkenyl sulfonates
(PMN P-16-186) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iv), (3), (6)(v) and (vi) (particulate), (b)
(concentration set at 1.0%), and (c). When determining which persons
are reasonable likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposures, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii) and (ix) (eye irritation), (2)(i) and (v) (eye protection), (4)(i)
through (iii), and (5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k). It is a significant new use to
manufacture, process or use of the substance in a manner that results
in inhalation exposure to vapor, dust, spray, mist, or aerosol.
    (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 (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 significant new use rule.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11224  Spiro tetrafluoroborate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as spiro
tetrafluoroborate (PMN P-16-207) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) through (5) and (6) (particulate), (b)(concentration set
at 1.0%), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (4), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposures, where feasible. For Sec.
721.63(a)(5), respirators must provide a NIOSH assigned protection
factor of at least 1000.
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.2 mg/m\3\ as
an 8-hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to Sec.  721.63 respirator requirements may request to do
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv) and
(ix), (2)(i) through (iv) and (v), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used. For Sec.
721.72(g)(2)(iv), use respiratory protection, or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
0.2 mg/m\3\.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k), and (q).
    (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 (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.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11225  2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-methoxyphenyl)-4,5-
difluoro-, phenylmethyl ester (PMN P-16-246, CAS No. 1391033-38-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iv), (3) through (6)(i) and (ii), (v) and
(vi), (b) (concentration set at 0.1%), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the

operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor of at least
50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) and
(ii), (iv), (vi), (vii) and (ix), (2)(i) through (v), (3)(i) and (ii),
(4)(iii), and (5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k). It is a significant new use to
manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (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 (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)(iii)
of this section.

Sec.  721.11226  2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride
(1:1).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (PMN P-16-516; CAS
No. 2173150-90-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iv), (3) through (6)(i) and (ii), (v) and
(vi), (b) (concentration set at 0.1%), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For Sec.  721.63(a)(5), respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set 0.1%), (f), (g)(1)(i) and
(ii), (iv), (vi), (vii) and (ix), (2)(i) through (v), (3)(i) and (ii),
(4)(iii), and (5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k). It is a significant new use to
manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (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 (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)(iii)
of this section.

Sec.  721.11227  1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, 1,2,4-trinonyl ester (PMNs P-16-271 and P-
16-450, CAS No. 35415-27-1) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) through (3) and (6) (particulate), (b) (concentration set
at 1.0%), and (c). When determining which persons are reasonable likely
to be exposed as required for Sec.  721.63(a)(1), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(iv), (vi) and (ix), (2)(i) and (v), and (4)(i) through (iii) and (v).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (p) (1,750,000 kilograms). It is a
significant new use to use the substance other than as a plasticizer in
wire and cable insulation.
    (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 (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.  721.11228  Aliphatic polyamines, polymers with bisphenol A and
epichlorohydrin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aliphatic polyamines, polymers with bisphenol A and epichlorohydrin
(PMN P-16-388) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3) and (6)(v) and (vi) (particulate),
(b) (concentration set at 1.0%) and (c). When determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace

policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i)
((mucous membrane irritation), (lung irritation), (eye irritation)),
(2)(i) (use gloves and eye protection), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (o).
    (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 (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.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11229  Epoxy-amine adduct, methanesulfonates (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as epoxy-
amine adduct, methanesulfonates (PMNs P-16-489, P-16-490, and P-16-491)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(2)(ii), (3)(i) and (ii), and (5). Alternative hazard and warning
statement that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o). It is a significant new use to
manufacture, process, or use the substances resulting in inhalation
exposure to vapor, mist, or aerosols.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=208 ppb.
    (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), (f) through (h), (i), and (k) 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.  721.11230  Modified ethylene-vinyl alcohol copolymer (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (2) The chemical substance identified generically as
modified ethylene-vinyl alcohol copolymer (PMN P-16-509) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
    (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 with
particle size less than 50 microns.
    (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.  721.11231  Cashew, nutshell liq., polymer with acid and
halohydrin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cashew,
nutshell liq., polymer with acid and halohydrin (PMN P-16-546) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iv), (3) through (6)(v) and (vi)
(particulate), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63 (a)(1) and (4)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor (APF) of at
least 50, or an APF of 1000 where the PMN substance has a use involving
an application method that generates vapor, mist or aerosol.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) ((skin sensitization), (respiratory
sensitization)), (2)(i) through (v), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o).
    (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 (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.  721.11232  Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pentaerythritol ester of mixed linear and branched carboxylic acids
(PMN P-16-589) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) and (6) (particulate), (b) (concentration set at
1.0%), and (c). When determining which persons are reasonable likely to
be exposed as required for Sec.  721.63(a)(1), engineering control
measures (e.g. enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible.

    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv)
through (vi) and (ix), (2)(i) through (v), (4) (minimize release to
water), and (5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k). It is a significant new use to
manufacture or process this substance in any manner that results in
inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4) and (b)(4), where N=330 ppb.
    (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 (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 significant new use rule.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11233  Cashew nut shell liquid, branched polyester-polyether
polyol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cashew
nut shell liquid, branched polyester-polyether polyol (PMN P-17-116) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (3) and (6) (particulate), (b) (concentration set
at 0.1%) and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
    (ii) Hazard communication: Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)
(sensitization), (2)(i) and (v), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (p) (65,000 kg), and (y)(1). It is a
significant new use to manufacture the PMN substance with greater than
0.1% weight residual cashew nut oil.
    (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 (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.  721.11234  Methylene diphenyl diisocyanate terminated
polyurethane resin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methylene diphenyl diisocyanate terminated polyurethane resin (PMN P-
17-121) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5) and (6)(v) and
(vi) (particulate), (b) (concentration set at 1.0%) and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For Sec.  721.63(a)(5), respirators must
provide NIOSH assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and
(ii) (asthma), (2)(i) through (v), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance for
consumer use or for commercial uses that could introduce the substance
into a consumer setting. It is a significant new use to manufacture the
substance without conducting medical surveillance as specified in the
Order. It is a significant new use to use the substance in a spray
application that results in inhalation exposure to a vapor, dust, mist,
spray, or aerosol.
    (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 (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.  721.11235  2-Furancarboxylic acid, tetrahydro-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-furancarboxylic
acid, tetrahydro- (PMN P-17-328, CAS No. 16874-33-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5) and (6)(v) and
(vi) (particulate), (b) (concentration set at 1.0%), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For Sec.  721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(vi)
((severe eye irritation), (blood effects), (immunotoxicity)), (2)(i)
through (iii) and (v) (eye protection), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f).
    (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 (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.  721.11236  Heteromonocycle, homopolymer, alkyl substituted
carbamate, alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
heteromonocycle, homopolymer, alkyl substituted carbamate, alkyl ester
(PMN P-17-373, chemical A and P-13-373 chemical B) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of the TSCA Order do
not apply to quantities of the substance after they have been
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (3) through (5) and (6)(v) and (vi)
(particulate), (b) (concentration set at 0.1%) and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For Sec.  721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i),
(vii) and (ix) ((sensitization), (systemic effects)), (2)(i) through
(iii) and (v), and (5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to
manufacture the substances unless the number average molecular weight
is greater than or equal to 1000 Daltons. It is a significant new use
to use the substances other than as an ultraviolet curable coating
resin.
    (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 (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.  721.11237  Polysiloxanes, di alkyl, substituted alkyl group
terminated, alkoxylated, reaction products with alkanoic acid,
isocyanate substituted-alkyl carbomonocycle and polyol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polysiloxanes, di alkyl, substituted alkyl group terminated,
alkoxylated, reaction products with alkanoic acid, isocyanate
substituted-alkyl carbomonocycle and polyol (PMN P-17-374) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of the TSCA Order
do not apply to quantities of the PMN substance after they have been
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (3) through (5) and (6)(v) and (vi)
(particulate), (b) (concentration set at 0.1%), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures.) shall be considered and implemented to
prevent exposure, where feasible. For Sec.  721.63(a)(5), respirators
must provide a NIOSH assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i),
(vii) and (ix) ((sensitization), (systemic effects)), (2)(i) through
(iii) and (v), and (5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import
the substance with more than 0.1% residual isocyanate. It is a
significant new use to import the substance at a number average
molecular weight less than 1000 Daltons. It is a significant new use to
use the substance other than as an ultraviolet curable coating resin.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=110.
    (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 (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.

Sec.  721.11238  Substituted carbomonocycle, polymer with substituted
heteromonocycle and substituted polyalkylene glycol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbomonocycle, polymer with substituted heteromonocycle
and substituted polyalkylene glycol (PMN P-18-17) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate),
(b) (concentration set at 0.1%), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For Sec.  721.63(a)(5), respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor of at least 1000.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i)
through (vii) and (ix) (irritation to eyes, lungs, and mucus
membranes), (2)(i) through (v) (avoid eye contact), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized

System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), It is a significant new use to import
the substance if the average molecular weight is less than or equal to
1000 Daltons, more than 10% is less than 500 Daltons, or more than 25%
is less than 1000 Daltons. It is a significant new use to use the
substance other than for primer coating for corrosion protection.
    (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 (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.  721.11239  Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid,
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl
substituted carbomonocycle and alkyl substituted alkanediol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol
reaction products, substituted alkanedioc acid, substituted alkanoic
acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and
alkyl substituted alkanediol (PMN P-18-40) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate),
and (c). When determining which persons are reasonably likely to be
exposed as required for Sec.  721.63(a)(1) and (4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For Sec.  721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 1000.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (vii) and (ix) ((irritation to
eyes, lungs, and mucous membranes), (dermal sensitization),
(respiratory sensitization)), (2)(i) through (v), and (5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import
the substance if the number average molecular weight is less than or
equal to 1000 Daltons or greater than 20% of the acid moiety. It is a
significant new use to use the substance other than as a binder for
ultraviolet curable coating resins.
    (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 (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.  721.11240  Substituted carbomonocycle, polymer with
diisocyanatoalkane, substituted alkylacrylate blocked (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbomonocycle, polymer with diisocyanatoalkane,
substituted alkylacrylate blocked (PMN P-18-46) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate),
(b)(concentration set at 0.1%), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
Sec.  721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor of at least
1000).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i),
(iv), (v), (vii) and (ix) ((irritation to eyes, lungs, and mucus
membranes), (dermal and respiratory sensitization)), (2)(i) through (v)
(avoid eye contact), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import
the substance if the average molecular weight is less than or equal to
1,390 Daltons, more than 11% is less than 500 Daltons, or more than 30%
is less than 1,000 Daltons. It is a significant new use to use the
substance other than as an ultraviolet curable resin.
    (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 (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.  721.11241  1,2-Ethanediol, 1,2-dibenzoate.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-Ethanediol,
1,2-dibenzoate (PMN P-18-47, CAS No. 94-49-5) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely
entrained in a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) through (5) and (6)(v) and (vi) (particulate), (b)
(concentration set at 1.0%), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
Sec.  721.63(a)(5), respirators must provide a National Institute for
Occupational

Safety and Health assigned protection factor of at least 25.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iii),
(iv), (vi), (viii) and (ix) (blood effects), (2)(i) and (ii), (iv) and
(v), (3)(i) and (ii), and (5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to use the
substance other than as a phlegmatizer (stabilizer for compounds
susceptible to detonation) for peroxides for use with polyester and
vinyl ester resins as well as with curable unsaturated polyester and
methacrylic resins.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=10.
    (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 (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.

Sec.  721.11242  Alkenoic acid, reaction products with
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with
isocyanatoalkane and substituted alkanoic acid, substituted
monoacrylate alkanoate-blocked (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, reaction products with
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with
isocyanatoalkane and substituted alkanoic acid, substituted
monoacrylate alkanoate-blocked (PMN P-18-51) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5), and (6)
(particulate), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor of at least
1000.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i) and (ix) ((irritation to eyes,
lungs, and mucous membranes), (dermal sensitization), (respiratory
sensitization)), (2)(i) through (v) (avoid eye contact), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to use the
substance other than as a waterborne ultraviolet curable coating resin
binder for inkjet, ink, or overprint varnish. It is a significant new
use to import the substance with greater than 24% of the branched alkyl
acid moiety content. It is a significant new use to import the
substance with greater than 0.1% isocyanate content.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=660.
    (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 (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.

Sec.  721.11243  Aromatic dicarboxylic acid, compound with alkane
diamines, polymer with alkane diamine and dicarboxylic acid (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dicarboxylic acid, compound with alkane diamines, polymer with
alkane diamine and dicarboxylic acid (PMN P-18-71) 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 with particle size
less than 10 microns.
    (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 significant new use rule.

Sec.  721.11244  Aromatic dicarboxylic acid, compound with alkyl
diamines, homopolymer (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dicarboxylic acid, compound with alkyl diamines, homopolymer
(PMN P-18-79) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance with particle size
less than 10 microns.
    (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 significant new use rule.

Sec.  721.11245  Aspartic acid, tallow modified diester (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aspartic acid, tallow modified diester (PMN P-18-82) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), (b) (concentration set at
1.0%), and (c). When determining which persons are reasonably likely to
be exposed as required for Sec.  721.63(a)(1), engineering control
measures (e.g., enclosure or confinement of the operation, general

and local ventilation) or administrative control measures (e.g.,
workplace policies and procedures) shall be considered and implemented
to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii)
and (iv), (2)(i), (ii) and (v), (3)(i) and (ii), (4)(iii) (above
concentration of 1 part per billion (ppb), and (5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(g). It is a significant new use to
manufacture, process, or use the substance that results in inhalation
exposure. It is a significant new use to manufacture, process and use
the substance other than as stated in the PMN.
    (iv) Disposal. Residuals must be recycled back into the process as
stated in the PMN.
    (v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), (c)(4), where N=1.
    (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 (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 paragraphs (a)(2)(iii)
and (iv) of this section.

Sec.  721.11246  Substituted alkanediol, polymer with heteromonocycles,
alkenoate, metal complexes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanediol, polymer with heteromonocycles, alkenoate, metal
complexes (PMN P-18-130) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (3) through (5) and (6)(v) and (vi)
(particulate), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (4)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor (APF) of at
least 50, or if spray applied an APF of 1000.
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i) ((sensitization),
(mutagenicity)), (2)(i) through (v), and (5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to use the
substance other than as an adhesion promoter for industrial
applications.
    (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 (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. 2019-26224 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P