Document ID: EPA-HQ-OPPT-2020-0588-0069
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances (21-1.5e)
Posted Date: 2022-12-02T05:00Z

[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Rules and Regulations]
[Pages 73941-73955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25807]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 721, and 725

[EPA-HQ-OPPT-2020-0588; FRL-8582-01-OCSPP]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (21-
1.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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) and a Microbial Commercial 
Activity Notice (MCAN). 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

[[Page 73942]]

notice, and has taken such actions as are required by that 
determination.

DATES: This rule is effective on January 31, 2023. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
December 16, 2022.

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 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 or 40 CFR 725.920 for the microorganism), 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-2020-0588, 
is available online at https://www.regulations.gov and in-person 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. Additional instructions 
on commenting and visiting the docket, along with more information 
about dockets generally, is 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 and an MCAN. 
Previously, in the Federal Register of June 11, 2021 (86 FR 31239) 
(FRL-10022-56), EPA proposed SNURs for these chemical substances and 
established the record for these SNURs in the docket under docket ID 
number EPA-HQ-OPPT-2020-0588. That 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

[[Page 73943]]

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. When this rule was proposed on June 11, 2021 
(86 FR 31239) (FRL-10022-56), EPA cross referenced 40 CFR 
721.1725(b)(1), the procedures to deal with the situation where a 
specific significant new use is CBI, in order to apply it other SNURs 
where certain significant new uses have been claimed as CBI. Since the 
proposed rule, however, EPA has finalized amendments to 40 CFR 721.11 
(87 FR 39756, July 5, 2022), which now provides a means by which bona 
fide submitters can determine whether their substance is subject to the 
SNUR and for EPA to disclose the confidential significant new use 
designations to a manufacturer or processor who has established a bona 
fide intent to manufacture or process a particular chemical substance. 
As such, EPA has removed the proposed references to 40 CFR 
721.1725(b)(1) for SNURs that certain significant new uses have been 
claimed as CBI because the procedure in 40 CFR 721.11 now applies to 
all SNURs containing any CBI, including the significant new use.
    Under these procedures 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 tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in 40 CFR 721.11 
into a single step to identify if a chemical substance is subject to 
part 721 and if a specific use would be a significant new use under the 
rule.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from three 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 made a change to one of the proposed rules as 
described in the response to comments.
    EPA made additional changes to the proposed rules because it 
inadvertently proposed incorrect terms in several SNURs. The revised 
language better reflects the language used in the underlying TSCA 
Orders for these chemical substances and these changes make the SNUR 
requirements consistent with those TSCA Orders. EPA received no 
comments on these requirements. For the SNURs for P-18-327 at 
721.11588, P-18-218 at 721.11581, P-18-217 at 721.11580, and P-18-178 
at 721.11579, EPA changed the language in paragraph (a)(1) exempting 
SNUR requirements from ``completely reacted (cured)'' to ``completely 
entrained,'' which more accurately reflects the exemption language in 
the underlying TSCA Orders. For the SNURs for P-16-424 at 721.11574 and 
P-20-42 at 721.11601, EPA removed the proposed reporting requirement 
specified at 721.72(g)(2)(iv). This would have required the inclusion 
of the term ``use respiratory protection'' in hazard communication 
materials; however, this requirement was not in the underlying TSCA 
Orders for these two chemical substances. For the SNUR for P-20-42 at 
721.11601, EPA added the reporting requirement specified at 721.72(f). 
This allows persons subject to the SNUR to use any existing hazard 
communication program that meets the requirements of the SNUR. The 
underlying TSCA Order for this chemical substance contains this 
requirement.

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).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA Order usually requires that potentially exposed 
employees wear specified respirators unless actual measurements of the 
workplace air show that air-borne concentrations of the PMN substance 
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs 
provisions in TSCA Orders include requirements addressing performance 
criteria for sampling and analytical methods, periodic monitoring, 
respiratory protection, and recordkeeping. No comparable NCEL 
provisions currently exist in 40 CFR part 721, subpart B, for SNURs. 
Therefore, for these cases, the individual SNURs in 40 CFR part 721, 
subpart E, will state that persons subject to the SNUR who wish to 
pursue NCELs as an alternative to the 40 CFR 721.63 respirator 
requirements may request to do so under 40 CFR 721.30. EPA expects that 
persons whose 40 CFR 721.30 requests to use the NCELs approach for 
SNURs that are approved by EPA will be required to comply with NCELs 
provisions that are comparable to those contained in the corresponding 
TSCA Order.

[[Page 73944]]

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.

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.
    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.

[[Page 73945]]

    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 analyses are 
available in each 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. 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 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.

C. 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, only a fraction of these were from 
small businesses. In addition, the Agency currently offers relief to 
qualifying small businesses by reducing the SNUN submission fee from 
$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.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

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

F. Executive Order 13175: Consultation and Coordination With Indian 
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

[[Page 73946]]

governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175 
(65 FR 67249, November 9, 2000), do not apply to this action.

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

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children. 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.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use and because this action is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

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

K. 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.

40 CFR Part 721

    Administrative practice and procedure, Chemicals, Environmental 
protection, Hazardous substances, Reporting and recordkeeping 
requirements.

40 CFR Part 725

    Administrative practice and procedure, Biologics, Chemicals, 
Environmental protection, Hazardous substances, Imports, Labeling, 
Microorganisms, Occupational safety and health, Reporting and 
recordkeeping requirements.

    Dated: November 17, 2022.
Tala Henry,
Deputy 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 in numerical order entries 
for Sec. Sec.  721.11571 through 721.11602 under the undesignated 
center heading ``Significant New Uses of Chemical Substances'' to read 
as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                             OMB control
                      40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11571..................................................    2070-0012
721.11572..................................................    2070-0012
721.11573..................................................    2070-0012
721.11574..................................................    2070-0012
721.11575..................................................    2070-0012
721.11576..................................................    2070-0012
721.11577..................................................    2070-0012
721.11578..................................................    2070-0012
721.11579..................................................    2070-0012
721.11580..................................................    2070-0012
721.11581..................................................    2070-0012
721.11582..................................................    2070-0012
721.11583..................................................    2070-0012
721.11584..................................................    2070-0012
721.11585..................................................    2070-0012
721.11586..................................................    2070-0012
721.11587..................................................    2070-0012
721.11588..................................................    2070-0012
721.11589..................................................    2070-0012
721.11590..................................................    2070-0012
721.11591..................................................    2070-0012
721.11592..................................................    2070-0012
721.11593..................................................    2070-0012
721.11594..................................................    2070-0012
721.11595..................................................    2070-0012
721.11596..................................................    2070-0012
721.11597..................................................    2070-0012
721.11598..................................................    2070-0012
721.11599..................................................    2070-0012
721.11600..................................................    2070-0012
721.11601..................................................    2070-0012
721.11602..................................................    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.  721.11571 through 721.11602 in numerical order to 
subpart E to read as follows:

Sec.
* * * * *
721.11571 Hindered amine alkyl ester compounds (generic).
721.11572 N-alkyl-dialkylpiperidine (generic).
721.11573 Tetraalkylpiperidinium halide (generic).
721.11574 Tetraalkylpiperidinium hydroxide (generic).
721.11575 Amidoamino quaternary ammonium salt (generic).
721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt 
(generic).
721.11577 Benzenediamine, ar-chloro-ar, ar-diethyl-ar-methyl-.
721.11578 1,4-benzenedicarboxylic acid, 1,4-dipentyl ester, branched 
and linear.
721.11579 Dialkyltin dialkylcarboxylate (generic).

[[Page 73947]]

721.11580 Alkyltin dodecylthioester (generic).
721.11581 Alkyltin tetradecylthioester (generic).
721.11582 Undecanol, branched.
721.11583 Hydroxy alkanoic acid, compds. with aminoalkoxyalcohol-
epoxy polymer-alkanolamine reaction products (generic).
721.11584 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with 
ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-
dimethylethyl)-4-hydroxy-, 2,2-bis(hydroxymethyl)butyl ester.
721.11586 1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1).
721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester.
721.11588 Mixed metal oxide (generic).
721.11589 Amines, polyethylenepoly-, triethylenetetramine fraction, 
polymers with guanidine hydrochloride (1:1).
721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) 
ester.
721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, 
branched and linear.
721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
721.11594 Alkenylamide (generic).
721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride 
(generic).
721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, 
acetate (salt) (generic).
721.11597 Alkanedioic acid, compds. with substituted arylalkylamine-
arylalcohol disubstituted alkane-the diglycidyl ether of a 
arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-
[(2-aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction 
products (generic).
721.11598 Polyazaalkane with oxirane and methyloxirane, haloalkane 
(generic).
721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
721.11600 Octanal, 7(or 8)-formyl-.
721.11601 Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-
alkanesulfonate (1:1) (generic).
721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether 
(generic).
* * * * *

Sec.  721.11571  Hindered amine alkyl ester compounds (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. The chemical substance generically identified as hindered 
amine alkyl ester compounds (PMN P-16-167) is subject to reporting 
under this section for the significant new use 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), (a)(2)(i) through (iv), (a)(3) through (6), 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 of 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), gas/vapor 
(all substances in gas form), and combination gas/vapor and particulate 
(gas and liquid/solid physical states are present).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) 
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; respiratory 
complications; central nervous system effects; blood effects. 
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 
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 and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11572  N-alkyl-dialkylpiperidine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as N-
alkyl-dialkylpiperidine (PMN P-16-419) 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), (a)(2)(i) through (iii), (a)(3) through (6), (b), and 
(c). When determining which persons are 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 10. For 
purposes of Sec.  721.63(a)(6), the airborne form(s) of the substance 
include gas/vapor (all substances in the gas form). 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), (g)(1), (g)(2)(i) through (v), (g)(3)(ii), 
(g)(4), and (g)(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; serious eye damage; acute toxicity; specific 
target organ toxicity. For purposes of Sec.  721.72(g)(4), notice to 
users: water release restrictions apply. 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(h).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=286.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.

[[Page 73948]]

    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11573  Tetraalkylpiperidinium halide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
tetraalkylpiperidinium halide (PMN P-16-423) 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), (a)(2)(i), (a)(3), (b), and (c). When determining which 
persons are 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), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(ii), (g)(4), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1.0%. For purposes of Sec.  721.72(g)(1), the 
substance may cause: acute toxicity; specific target organ toxicity; 
reproductive toxicity. For purposes of Sec.  721.72(g)(4), notice to 
users: water release restrictions apply. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 20.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11574  Tetraalkylpiperidinium hydroxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
tetraalkylpiperidinium hydroxide (PMN P-16-424) 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), (a)(2)(i) through (iii), (a)(3), (b), and (c). When 
determining which persons are 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), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(ii), (g)(4), and (g)(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; serious eye damage; acute 
toxicity; specific target organ toxicity; reproductive toxicity. For 
purposes of Sec.  721.72(g)(4), notice to users: water release 
restrictions apply. 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)(4), (b)(4) and (c)(4), where N=20.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11575  Amidoamino quaternary ammonium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
amidoamino quaternary ammonium salt (PMN P-17-235) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 44.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11576  Tri alkyl, mono alkoxy, fatty acid ester, ammonium 
salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as tri 
alkyl, mono alkoxy, fatty acid ester, ammonium salt (PMN P-18-226) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 44.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11577  Benzenediamine, ar-chloro-ar, ar-diethyl-ar-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenediamine, ar-
chloro-ar, ar-

[[Page 73949]]

diethyl-ar-methyl- (PMN P-17-259; CAS No. 1616795-05-1) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the PMN substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 1.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11578  1,4-benzenedicarboxylic acid, 1,4-dipentyl ester, 
branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-dipentyl ester, branched and linear (PMN 
P-18-43; CAS No. 2097734-13-7) 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 PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=2.
    (ii) [Reserved]
    (b) Specific requirements. The provision of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11579  Dialkyltin dialkylcarboxylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dialkyltin dialkylcarboxylate (PMN P-18-178) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
entrained.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are 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 10. 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. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11580  Alkyltin dodecylthioester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkyltin dodecylthioester (PMN P-18-217) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely entrained.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
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) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section

Sec.  721.11581  Alkyltin tetradecylthioester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkyltin tetradecylthioester (PMN P-18-218) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
entrained.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
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) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a stabilizer for 
PVC compounds.
    (iii) 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), (i), and (k) are

[[Page 73950]]

applicable to manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section

Sec.  721.11582  Undecanol, branched.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as undecanol, branched 
(PMN P-18-256; CAS No. 203743-00-4) is subject to reporting under this 
section for the significant new use described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the PMN 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(g).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 4.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11583  Hydroxy alkanoic acid, compds. with 
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as hydroxy 
alkanoic acid, compds. with aminoalkoxyalcohol-epoxy polymer-
alkanolamine reaction products (PMN P-18-283) 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), (a)(2)(i) through (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) and (v), (g)(3)(ii), 
(g)(4)(iii), 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; skin sensitization; eye 
irritation; specific target organ 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) 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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11584  1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxy methyl]oxirane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 1,3-
propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with ethyleneamine, 2-
(chloromethyl)oxirane, 2-[[4-(1,1-dimethylethyl)phenoxy]methyl]oxirane, 
2,2'-[1,6-hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxy methyl]oxirane (PMN P-18-298) 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 PMN 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). It is a significant new use to 
manufacture, process, or use the PMN substance for an application 
method that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=50.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11585  Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-dimethylethyl)-4-hydroxy-, 2,2-bis(hydroxymethyl)butyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenepropanoic 
acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxy-, 2,2-
bis(hydroxymethyl)butyl ester (PMN P-18-310; CAS No. 2101609-93-0) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), 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 1,000. 
For purposes of Sec.  721.63(a)(6), the airborne form(s) of the 
substance include gas/vapor and particulate.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.16 
mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator

[[Page 73951]]

requirements may request to do so under Sec.  721.30. Persons whose 
Sec.  721.30 requests to use the NCELs approach are approved by EPA 
will be required to follow NCELs provisions comparable to those 
contained in the corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(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; 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) 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 (h), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11586  1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-octadecanaminium, 
N,N-dimethyl-N-[3-(triethoxysilyl)propyl]-, chloride (1:1) (PMN P-18-
318; CAS No. 62117-57-1) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a surface 
treatment for added lubricity and anti-static properties. It is a 
significant new use to use the substance in an application method that 
results in inhalation exposure to workers.
    (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 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11587  2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl 
ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
2-methyl-, 3-methyl-3-buten-1-yl ester (PMN P-18-323; CAS No. 156291-
88-2) 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 PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), 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) and gas/vapor 
(all substances in the gas form).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) 
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; developmental 
effects; systemic effects; respiratory effects; skin sensitization; 
respiratory sensitization. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(k).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 98.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11588  Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as mixed 
metal oxide (PMN P-18-327) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely entrained.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), 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 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include 
particulate (including solids or liquid droplets).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.1 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

[[Page 73952]]

under Sec.  721.30. Persons whose Sec.  721.30 requests to use NCELs 
approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(2), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: cancer; skin 
sensitization; respiratory 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. For purposes of Sec.  721.72(g)(2), 
when using this substance: 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 0.1 mg/m\3\, and use skin protection.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h) are applicable to manufacturers and processors 
of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11589  Amines, polyethylenepoly-, triethylenetetramine 
fraction, polymers with guanidine hydrochloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amines, 
polyethylenepoly-, triethylenetetramine fraction, polymers with 
guanidine hydrochloride (1:1) (PMN P-18-347; CAS No. 1902936-67-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) 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%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(i) and (ii), 
(g)(4)(i), 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: acute toxicity; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 2.
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11590  Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 4,4'-(1-
methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1, 13-
diene, glycidyl ether (PMN P-18-405; CAS No. 647028-24-8) 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 PMN 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). It is a significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 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 modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11591  1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) 
ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester (PMN P-19-36; 
CAS No. 25900-07-6) 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 PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3) through (6), 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 
of 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 3.
    (b) Specific requirements. The provisions of subpart A of this part 
may 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 (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11592  Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, branched and linear

[[Page 73953]]

(PMN P-19-52; CAS No. 2242406-13-7) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iii), (a)(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 (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 1,000. 
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 1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (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; respiratory complications; internal organ 
effects; eye corrosion. 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 use. It is a significant 
new use to use the substance where the concentration of the substance 
in the product formulation intended for distribution in commerce 
exceeds 1% by weight.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 34.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11593  1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanamine, N-
butyl-N-[(triethoxysilyl)methyl]- (PMN P-19-53; CAS No. 35501-23-6) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (o). It is a significant new use to 
process and use the substance other than in a liquid formulation.
    (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) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11594  Alkenylamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenylamide (PMN P-19-77) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 4.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11595  Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride (PMN P-19-131) 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 destroyed (e.g., reacted to bind with clay).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(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; 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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is significant new use to 
manufacture, process, or use the PMN substance in a manner that results 
in inhalation exposure.
    (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 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 73954]]

Sec.  721.11596  Aldehyde, polymer with mixed alkane polyamines, 2,2'-
[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate 
(salt) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 4,4'-
(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate 
(salt) (PMN P-19-143) 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 PMN 
substance after they have been completely reacted (cured) or destroyed.
    (2) The significant new uses are:
    (i) 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 PMN substance in a manner that results 
in inhalation exposure to either the PMN substance or to formaldehyde.
    (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 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11597  Alkanedioic acid, compds. with substituted 
arylalkylamine-arylalcohol disubstituted alkane-the diglycidyl ether of 
a arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol 
disubstituted alkane-the diglycidyl ether of a arylalcohol 
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products 
(PMN P-19-144) 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) or destroyed.
    (2) The significant new uses are:
    (i) 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 PMN substance in a manner that results 
in inhalation exposure to either the PMN substance or to formaldehyde.
    (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 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11598  Polyazaalkane with oxirane and methyloxirane, 
haloalkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
polyazaalkane with oxirane and methyloxirane, haloalkane (PMN P-19-145) 
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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), 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: 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.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in a manner that results in inhalation exposure.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 26.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (h), (i) and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11599  Dibromoalkyl ether tetrabromobisphenol A (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dibromoalkyl ether tetrabromobisphenol A (PMN P-19-153) 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), (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)(3)(ii), and (g)(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; 
carcinogenicity; 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) 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 (h), and (k) are

[[Page 73955]]

applicable to manufacturers and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11600  Octanal, 7(or 8)-formyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octanal, 7(or 8)-
formyl- (PMN P-20-29; CAS No. 1607842-40-9) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 17.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11601  Sulfonium, trisaryl-, 7, 7-dialkyl-2-heteropolycyclic-
1-alkanesulfonate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
sulfonium, trisaryl-, 7, 7-dialkyl-2-heteropolycyclic-1-alkanesulfonate 
(1:1) (PMN P-20-42) 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 
the photolithographic process) 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 1.0%. 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 PMN substance other than in solution, unless in 
sealed containers weighing 5 kilograms or less. It is a significant new 
use to process the PMN substance in any way that generates a dust, 
mist, or aerosol in a non-enclosed process. It is a significant new use 
to manufacture the PMN 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 and processors 
of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11602  Alkenoic acid, polymer with (alkyl alkenyl) polyether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenoic acid, polymer with (alkyl alkenyl) polyether (PMN P-20-104) 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). It is a significant new use to 
manufacture, process, or use the substance in a manner that results in 
inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N = 75.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain modification requirements. 
The provisions of Sec.  721.185 apply to this section.
* * * * *

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

0
3. The authority citation for part 725 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

0
4. Add Sec.  725.1081 to read as follows:

Sec.  725.1081  Trichoderma reesei modified (generic).

    (a) Microorganism and significant new uses subject to reporting. 
(1) The genetically modified microorganism generically identified as 
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2)(i) It is a significant new use to manufacture, process, or use 
the microorganism other than in a fermentation system that meets all of 
the following conditions:
    (A) Enzyme production occurs by submerged fermentation (i.e., for 
enzyme production, growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (B) Any fermentation of solid plant material or insoluble substrate 
to which Trichoderma reesei fermentation broth is added after the 
standard industrial fermentation is completed is initiated only after 
the inactivation of the microorganism as delineated in Sec.  
725.422(d).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart L of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
725.950(b)(2) through (4) are applicable to manufacturers and 
processors of this microorganism.
    (2) Modification or revocation of certain notification 
requirements. The provisions of Sec.  725.984 apply to this section.

[FR Doc. 2022-25807 Filed 12-1-22; 8:45 am]
BILLING CODE 6560-50-P