Significant New Use Rules on Certain Chemical Substances (21-3.5e), 13696-13713 [2023-04157]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Rules and Regulations]
[Pages 13696-13713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04157]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2021-0568; FRL-9779-02-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (21-
3.5e)

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 were 
the subject of premanufacture notices (PMNs). 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. The required notification 
initiates EPA's evaluation of the use, under the conditions of use for 
that chemical substance, within the applicable review period. Persons 
may not commence manufacture or processing for the significant new use 
until EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
by that determination.

DATES: This rule is effective on May 5, 2023. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on March 20, 
2023.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4163; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers

[[Page 13697]]

are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions 
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, which would 
include 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 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 dockets?

    The dockets include information considered by the Agency in 
developing the proposed and final rules. The docket for this action, 
identified by docket identification (ID) number EPA-HQ-OPPT-2021-0568, 
is available at https://www.regulations.gov and 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 https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for certain 
chemical substances which were the subject of PMNs. Previously, EPA 
proposed SNURs for these chemical substances and established the record 
for these SNURs in the following Federal Register and docket ID number:
     June 24, 2022 (87 FR 37783) (FRL-9779-01-OCSPP); Docket ID 
No. EPA-HQ-OPPT-2021-0568.
    EPA will address finalizing the proposed SNURs for certain chemical 
substances not included in this final rule in a future Federal Register 
document. The docket includes information considered by the Agency in 
developing the proposed and final rules, including public comments and 
EPA's responses to the public comments received.

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 bulleted TSCA section 5(a)(2) 
factors listed in Unit III.

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. Pursuant to 
40 CFR 721.1(c), persons subject to these SNURs must comply with the 
significant new use notice (SNUN) requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA 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 and before 
the manufacture or processing for the significant new use can commence, 
EPA must either determine that the significant new use is not likely to 
present an unreasonable risk of injury or take such regulatory action 
as is associated with an alternative determination. If EPA determines 
that the significant new use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
findings.

III. Significant New Use Determination

A. Considerations for Significant New Use Determinations

    When the Agency issues an order under TSCA section 5(e), section 
5(f)(4) requires that the Agency consider whether to promulgate a SNUR 
for any use not conforming to the restrictions of the TSCA 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, and 
potential human exposures and environmental releases that may be 
associated with possible uses of these chemical substances, in the 
context of the four bulleted TSCA section 5(a)(2) factors listed in 
this unit.

B. Procedures for Significant New Uses Claimed as CBI

    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.
    Under the procedures in 40 CFR part 721.11 a manufacturer or 
processor may request EPA to determine whether a specific 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 identify any confidential 
significant new use designations 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 721.11 into a single step to 
identify if a chemical substance is subject to 40 CFR part 721 and if a 
specific use would be a significant new use under the rule.
    In the proposed SNURs, EPA referenced 40 CFR 721.1725(b)(1) each 
time the agency proposed issuing a SNUR containing a significant new 
use

[[Page 13698]]

designation containing CBI. Since, EPA has modified the bona fide 
procedure in 40 CFR 721.11 of subpart A so that it applies to all SNURs 
containing any CBI, including the significant new use (87 FR 39764, 
July 5, 2022 (FRL-5605-02-OCSPP)). EPA has revised the regulatory text 
in the final rule and removed the reference to 40 CFR 721.1725(b)(1) 
each time the agency issued a final SNUR containing a significant new 
use designation containing CBI.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from two identifying entities on the 
proposed rules. The Agency's responses are presented in the Response to 
Public Comments document that is available in the public docket for 
this rulemaking. EPA updated the chemical IDs in the SNURs for P-19-98, 
P-20-58, and P-21-63 as described in the response to comments.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for chemical substances in 40 CFR part 721, subpart E. In 
Unit IV. of the proposed SNURs, EPA provided the following information 
for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as confidential business information (CBI)).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Effective date of and basis for the TSCA Order.
     Potentially Useful Information. This is information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the chemical substances if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
these rules.
    The regulatory text section of these rules specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits and other uses designated in the rules, may be 
claimed as CBI.
    These final rules include PMN substances that are subject to orders 
issued under TSCA section 5(e)(1)(A), as required by the determinations 
made under TSCA section 5(a)(3)(B). Those TSCA Orders require 
protective measures to limit exposures or otherwise mitigate the 
potential unreasonable risk. The final 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 TSCA Orders, consistent with TSCA section 5(f)(4).

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 and as further discussed in Unit IV. of 
the proposed rules, 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. Based on such findings, TSCA 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 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
     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.
     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; and
     Be obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under TSCA section 5(a)(3)(C) 
that significant new use is not likely to present an unreasonable risk, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by the Administrator under the 
conditions of use, or make a determination under TSCA section 
5(a)(3)(A) or (B) and take the required regulatory action associated 
with the determination, before manufacture or processing for the 
significant new use of the chemical substance can occur.
    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 
https://www.epa.gov/tsca-inventory.

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 Orders have been issued for all the 
chemical substances that are the subject of this rule, and the PMN 
submitters are prohibited by the TSCA Orders from undertaking 
activities which will be designated as significant new uses. The 
identities of many of the chemical substances subject to this rule have 
been claimed as confidential (per 40 CFR 720.85). 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 the publication dates of the proposed 
rules (see Unit II.) as the cutoff dates for determining whether the 
new uses are 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 the abovementioned dates, that person will have to 
cease any such activity upon the effective date of the final rule. To 
resume their activities, that person would have to first comply with 
all applicable SNUR notification requirements and wait until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.

[[Page 13699]]

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, TSCA 
Order or consent agreement under TSCA section 4, then TSCA section 
5(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, TSCA 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 them or reasonably 
ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs 
and SNUNs, the Agency has the authority to require appropriate testing. 
Unit IV. of the proposed rule lists potentially useful information for 
all SNURs listed in this document. Descriptions are provided for 
informational purposes. The information identified in Unit IV. of the 
proposed rule will be potentially useful to EPA's evaluation in the 
event that someone submits a SNUN for the significant new use. 
Companies who are considering submitting a SNUN are encouraged, but not 
required, to develop the information on the substance.
    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 in vertebrate animals, EPA 
encourages consultation with the Agency on the use of alternative test 
methods and strategies (also called New Approach Methodologies, or 
NAMs), if available, to generate the recommended test data. EPA 
encourages dialog with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h). For more information on alternative test methods and 
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    In some of the TSCA Orders for the chemical substances identified 
in this rule, EPA has established production volume and time limits in 
view of the lack of data on the potential health and environmental 
risks that may be posed by the significant new uses or increased 
exposure to the chemical substances. These limits cannot be exceeded 
unless the PMN submitter first submits the results of specified tests 
that would permit a reasoned evaluation of the potential risks posed by 
these chemical substances. The SNURs contain the same limits as the 
TSCA 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 
proposed rule may not be the only means of addressing the potential 
risks of the chemical substance associated with the designated 
significant new uses. 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 be aware that EPA will be better able to 
evaluate SNUNs that 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. 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 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

X. 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 listed in Unit II.

XI. 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. 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. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is not subject to Executive Order 13771 (82 FR 9339, 
February 3, 2017), because this action is not a significant regulatory 
action under Executive Order 12866.

C. 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 PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The information collection requirements associated with SNURs 
have already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0012 (EPA ICR No. 574). This rule does not impose any 
burden requiring additional OMB approval.
    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

[[Page 13700]]

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. The Information Collection Request (ICR) covering the 
SNUR activities 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.
    If an entity were to submit a SNUN to the Agency, the annual burden 
is estimated to average between 30 and 170 hours per response. This 
burden estimate includes the time needed to review instructions, search 
existing data sources, gather and maintain the data needed, and 
complete, review, and submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
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.

D. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that promulgation of these SNURs would not have 
a significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, EPA has concluded that no small or large entities 
presently engage in such activities. A SNUR requires that any person 
who intends to engage in such activity in the future must first notify 
EPA by submitting a SNUN. Although some small entities may decide to 
pursue a significant new use in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of SNURs covering over 
1,000 chemicals, the Agency receives only a small number of notices per 
year. For example, the number of SNUNs received was 10 in Federal 
fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019, 
seven in FY2020, and 13 in FY2021, 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 she from 
$19,020 to $3,330. This lower fee reduces the total reporting and 
recordkeeping of cost of submitting a SNUN to about $11,164 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.

E. 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.).

F. 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).

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribe 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.

H. 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. EPA interprets Executive Order 
13045 as applying only to those regulatory actions that concern 
environmental health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order.

I. 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.

J. National Technology Transfer and Advancement Act (NTTAA)

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

K. 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).

L. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA 
will submit a rule report containing this rule and other required 
information to each House of the Congress and to the Comptroller 
General of the United States. 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.

[[Page 13701]]

40 CFR Part 721

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

    Dated: February 23, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended as follows:

PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

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; 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, amend the table by adding entries for Sec. Sec.  
721.11687 through 721.11715 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.

* * * * *

------------------------------------------------------------------------
              40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11687.................................  2070-0012
721.11688.................................  2070-0012
721.11689.................................  2070-0012
721.11690.................................  2070-0012
721.11691.................................  2070-0012
721.11692.................................  2070-0012
721.11693.................................  2070-0012
721.11694.................................  2070-0012
721.11695.................................  2070-0012
721.11696.................................  2070-0012
721.11697.................................  2070-0012
721.11698.................................  2070-0012
721.11699.................................  2070-0012
721.11700.................................  2070-0012
721.11701.................................  2070-0012
721.11702.................................  2070-0012
721.11703.................................  2070-0012
721.11704.................................  2070-0012
721.11705.................................  2070-0012
721.11706.................................  2070-0012
721.11707.................................  2070-0012
721.11708.................................  2070-0012
721.11709.................................  2070-0012
721.11710.................................  2070-0012
721.11711.................................  2070-0012
721.11712.................................  2070-0012
721.11713.................................  2070-0012
721.11714.................................  2070-0012
721.11715.................................  2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

Subpart E--Significant New Uses for Specific Chemical Substances

0
4. Add Sec. Sec.  721.11687 through 721.11715 in numerical order to 
subpart E to read as follows:

Sec.
* * * * *
721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl 
alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and 
tris-[(alkylamino) alkyl] phenol (generic).
721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-
alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked 
(generic).
721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) 
ester.
721.11690 Carbomonocylic-oxazolidine (generic).
721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).
721.11692 Phosphoric acid, polymer with 2,2-bis(hydroxymethyl)-1,3-
propanediol and 1,2-ethanediol.
721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-
substituted)ethyl ester (generic).
721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-
acyl derivs. (generic).
721.11695 Modified graphene (generic).
721.11696 Maltodextrin, polymer with 2-propenoic acid and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride 
(1:1), sodium salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium 
salt (1:2)-initiated.
721.11697 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112)
721.11698 Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113)
721.11699 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114)
721.11700 Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115)
721.11701 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116)
721.11702 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117)
721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated 
(generic).
721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-
1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, 
inorganic salt (generic).
721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate 
(1:1) (generic).
721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-
methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) 
(generic).
721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-
alkenesulfonic acid (1:1) (generic).
721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy 
carbomonocyclic salt (generic).
721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (generic).
721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer 
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) 
(generic).
721.11713 Pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).
721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).
721.11715 Nonane, branched.
* * * * *

[[Page 13702]]

Sec.  721.11687  Fatty acids, tall-oil polymers with aminoalkyl, 
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine 
fraction, and tris-[(alkylamino)alkyl] phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, 
polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) 
alkyl] phenol (PMN P-18-143) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11688  Isocyanic acid, polyalkylenepolycycloalkylene ester, 
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol 
and 1-alkoxy alkanol and alkylene diol blocked (PMN P-18-154) 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) and (3) 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 (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
respiratory sensitization; germ cell mutagenicity. For purposes of 
Sec.  721.72(g)(3), this substance may be: toxic to aquatic life. 
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). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11689  1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester (PMN P-18-
273; CAS No. 84731-70-4) 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) and (3), (b), 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. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
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 (k).
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11690  Carbomonocylic-oxazolidine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbomonocylic-oxazolidine (PMN P-18-290) 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) and (3) through (5), (a)(6)(v) and (vi), (b), 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 10. For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f) and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: eye irritation; specific target 
organ toxicity. For

[[Page 13703]]

purposes of Sec.  721.72(g)(3), this substance may be: toxic to aquatic 
life. Alternative hazard and warning statements that meet the criteria 
of the Globally Harmonized System and OSHA Hazard Communication 
Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=285.
    (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 (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11691  Propoxylated, ethoxylated alkoxyalkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
propoxylated, ethoxylated alkoxyalkyl ether (PMN P-19-73) 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) and (3) through (6) 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; serious 
eye damage; specific target organ toxicity. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. 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 process the substance for use in a consumer 
product where the concentration of the substance is 1% or greater in 
the consumer product formulation.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=24.
    (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, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11692  Phosphoric acid, polymer with 2,2-bis(hydroxymethyl)-
1,3-propanediol and 1,2-ethanediol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphoric acid, 
polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol and 1,2-ethanediol 
(PMN P-19-98; CAS No. 2248116-55-2) 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) and (3) through (6), (b), 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin corrosion; severe eye 
damage; reproductive toxicity; specific target organ toxicity. 
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). It is a significant new use to use the 
substance other than as a flame retardant additive for intumescent 
coatings.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=500.
    (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, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11693  2-Propenoic acid, 2-(hydrogenated animal-based 
nitrogen-substituted)ethyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl 
ester (PMN P-19-122) 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) and (3) through (6) 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for

[[Page 13704]]

Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin corrosion; serious 
eye damage; skin sensitization; reproductive toxicity; specific target 
organ toxicity. For purposes of Sec.  721.72(g)(3), this substance may 
be: toxic to aquatic life. 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 in consumer applications.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11694  2-Propenoic acid, nitrogen-substituted alkyl, N-C16-
18-acyl derivs. (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (PMN 
P-20-83) 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) and (3) through (6) 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin corrosion, serious 
eye damage, skin sensitization, reproductive toxicity, and specific 
target organ toxicity. For purposes of Sec.  721.72(g)(3), this 
substance may be: toxic to aquatic life. 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 in consumer applications.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11695  Modified graphene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified graphene (PMN P-20-5) 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 reacted 
(cured), embedded into a thermoset polymer resin as an intermediate 
step before curing, or embedded into a permanent solid polymer form 
that is not intended to undergo further processing, except mechanical 
processing or physical blending.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) through (6) 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. Where workers are reasonably expected to be exposed by 
inhalation to dust from the substance, dust controls shall be 
implemented that demonstrate an exposure reduction of at least 90%. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
use the substance in an application method that results in inhalation 
exposure to workers.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1) and 
(2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to 
release the substance directly to air.
    (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 (e) and (i) through (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11696  Maltodextrin, polymer with 2-propenoic acid and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride 
(1:1), sodium salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt 
(1:2)-initiated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as maltodextrin, 
polymer with 2-propenoic acid and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]ethanaminium chloride (1:1), sodium salt, 
peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated (PMN 
P-20-58; CAS No. 1646857-41-1) is subject to

[[Page 13705]]

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) and (3), (b), 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. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f) and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
For the purposes of Sec.  721.72(g)(3), this substance may be: toxic to 
aquatic life. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=102.
    (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 (h) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11697  Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(PMN P-20-112) 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 incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11698  Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-113).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with substituted tricarboxylic acid, 
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (PMN P-20-113) 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 incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(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 purposes

[[Page 13706]]

of Sec.  721.63(a)(5), respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11699  Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(PMN P-20-114) 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 incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (a)(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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets). For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 13707]]

Sec.  721.11700  Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-115).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with substituted tricarboxylic acid, 
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (PMN P-20-115) 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 incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11701  Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(PMN P-20-116) 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 incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include. For purposes of Sec.  721.63(b), the 
concentration is set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements:

[[Page 13708]]

arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead, 
manganese, mercury, nickel, selenium, silver, vanadium, and zinc. It is 
a significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11702  Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(PMN P-20-117) 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 incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (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 Order for this substance. The NCEL is 0.05 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 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. 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 substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11703  Silsesquioxanes, alkyl, alkoxy- and hydroxy- 
terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (PMN P-20-173) 
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) and (3) through (6), (b), 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f) and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; serious eye damage; specific target organ toxicity. For 
purposes of Sec.  721.72(g)(3), this substance may cause: aquatic 
toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=1.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 13709]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11704  1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 
1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, hexanedioic 
acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-
[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate (PMN P-21-10; 
CAS No. 2460376-09-2) 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) and (3) 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 (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, skin sensitization, and respiratory sensitization. 
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). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11705  Methyl phenylethyl cyclopropanemethanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as methyl 
phenylethyl cyclopropanemethanol (PMN P-21-13) 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) and (3) through (5), (a)(6)(v) and (vi), 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: eye irritation; skin 
sensitization. For purposes of Sec.  721.72(g)(3), this substance may 
be: toxic to aquatic life. 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 use the substance in consumer products unless 
the concentration of the substance is less than 1%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11706  [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, 
inorganic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
[(substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt 
(PMN P-21-17) 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 completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) through (6), 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin sensitization; specific 
target organ toxicity. 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

[[Page 13710]]

new use to use the substance other than as an additive to improve 
physical properties in rubber products.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11707  Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (PMN P-
21-18) 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 or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), 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 (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. 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), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11708  Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-
carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-
benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (PMN P-21-23) 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 or adhered onto a semiconductor wafer surface 
or similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), 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 (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. 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), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11709  Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic 
acid (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-
9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (PMN 
P-21-64) 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 or adhered onto a 
semiconductor wafer surface or similar manufactured article used in the 
production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), 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

[[Page 13711]]

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 (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. 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), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11710  Heteropolycyclic, trihaloalkyl carbomonocycle-, 
hydroxy carbomonocyclic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic 
salt (PMN P-21-27) 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 or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), 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 (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. 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), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11711  Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (PMN P-21-42) 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 or adhered (during photolithographic processes) onto 
a semiconductor wafer surface or similar manufactured article used in 
the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), 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 (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. 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), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 13712]]

Sec.  721.11712  2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer 
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl 
alkenoate and octadecyl alkenoate, acetate (salts) (PMN P-21-54) 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 an article as defined at Sec.  720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), 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. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; and specific target organ toxicity. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. 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 or process the substance in any 
manner that results in inhalation exposure. It is a significant new use 
to use the substance in an application method that results in 
inhalation exposure. It is a significant new use to use the substance 
in a product that is applied by a consumer.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=52. Before totaling the 
releases of the substance to water from all operations at a site as 
described in 40 CFR 721.91(a)(5), you may subtract up to 90 percent for 
any releases that will be treated using primary and secondary 
wastewater treatment as defined in 40 CFR part 133.
    (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, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11713  Pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl 
ester (PMN P-21-63) 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) and (3), (b), 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. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; acute 
toxicity; reproductive toxicity; specific target organ toxicity. For 
purposes of Sec.  721.72(g)(3), this substance may be: toxic to aquatic 
life. 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).
    (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, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11714  Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate 
polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (PMN P-21-65) 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) and (3) through (6) 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. 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). It is a significant new use to use the 
substance in a spray application.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 13713]]

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, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11715  Nonane, branched.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nonane, branched 
(PMN P-21-125; CAS No. 85408-10-2) 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) and (3) through (5), (a)(6)(v) and (vi), (b), 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50. For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%.
    (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 Order for this substance. The NCEL is 0.72 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 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; reproductive toxicity; specific target organ toxicity; 
aspiration hazard. For purposes of Sec.  721.72(g)(3), this substance 
may be: toxic to aquatic life. 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).
    (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, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2023-04157 Filed 3-3-23; 8:45 am]
BILLING CODE 6560-50-P