Proposed Rule2025-19673
Modification of Significant New Use Rules of Certain Chemical Substances (23-1.M)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 28, 2025
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs), a Microbial Commercial Activity Notice (MCAN) for one substance, and in some cases significant new use notices (SNUNs). This action would amend the SNURs to (1) allow certain new uses reported in the SNUNs or PMNs without additional notification requirements, (2) modify the significant new use notification requirements based on the actions and determinations for the SNUN or PMN submissions or based on the examination of new test data or other information, and (3) make technical amendments to several SNURs. EPA is proposing these amendments based on our review of new and existing data for the chemical substances.
Full Text
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[Federal Register Volume 90, Number 206 (Tuesday, October 28, 2025)]
[Proposed Rules]
[Pages 48717-48725]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19673]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 206 / Tuesday, October 28, 2025 /
Proposed Rules
[[Page 48717]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721 and 725
[EPA-HQ-OPPT-2022-0863; FRL-12967-01]
RIN 2070-AB27
Modification of Significant New Use Rules of Certain Chemical
Substances (23-1.M)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to amend the significant new use rules
(SNURs) for certain chemical substances identified herein, which were
the subject of one or more premanufacture notices (PMNs), a Microbial
Commercial Activity Notice (MCAN) for one substance, and in some cases
significant new use notices (SNUNs). This action would amend the SNURs
to (1) allow certain new uses reported in the SNUNs or PMNs without
additional notification requirements, (2) modify the significant new
use notification requirements based on the actions and determinations
for the SNUN or PMN submissions or based on the examination of new test
data or other information, and (3) make technical amendments to several
SNURs. EPA is proposing these amendments based on our review of new and
existing data for the chemical substances.
DATES: Comments must be received on or before November 28, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0863, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting and visiting the docket, along with more information about
dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Brianna Godwin, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 565-0076; email address:
<a href="/cdn-cgi/l/email-protection#27404843504e490945554e464949466742574609404851"><span class="__cf_email__" data-cfemail="583f373c2f3136763a2a3139363639183d2839763f372e">[email protected]</span></a>.
For general information on SNURs: 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:
<a href="/cdn-cgi/l/email-protection#47303e3428292069302e2b2b2e262a0722372669202831"><span class="__cf_email__" data-cfemail="c7b0beb4a8a9a0e9b0aeababaea6aa87a2b7a6e9a0a8b1">[email protected]</span></a>.
For general information on TSCA: The TSCA Assistance Information
Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-
1404; email address: <a href="/cdn-cgi/l/email-protection#0a5e59494b2742657e6663646f4a6f7a6b246d657c"><span class="__cf_email__" data-cfemail="89dddacac8a4c1e6fde5e0e7ecc9ecf9e8a7eee6ff">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. 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 factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.). Procedures and criteria for modifying
or revoking SNUR requirements appear at 40 CFR 721.185 or 725.984 (for
microorganisms).
B. What action is the Agency taking?
EPA is proposing amendments to the SNURs for certain chemical
substances in 40 CFR part 721, subpart E and part 725, subpart M (for
microorganisms). A SNUR for a chemical substance designates certain
activities as a significant new use. Persons who intend to manufacture
or process the chemical substance for the significant new use must
notify EPA at least 90 days before commencing that activity. The
required notification (i.e., a SNUN) initiates EPA's evaluation of the
intended use. Manufacture and processing for the significant new use
may not commence until EPA has conducted a review of the notice, made
an appropriate determination on the notice, and taken such actions as
are required in association with that determination.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed 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:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements in 19 CFR 12.118 through 12.127; see also 19 CFR
127.28. The EPA policy in support of import certification appears at 40
CFR part 707, subpart B. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including regulations issued under TSCA sections
5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20 or 40 CFR 725.920 (for microorganisms),
any persons who export or intend to export a chemical substance
identified in this document are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
D. What are the incremental economic impacts of this action?
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
[[Page 48718]]
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your comment, please
follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at <a href="https://www.epa.gov//epa-dockets">https://www.epa.gov//epa-dockets</a>.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
A. Significant New Use Determination Factors
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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining whether and how to modify EPA's identification of
significant new uses for the chemical substances that are the subject
of these SNURs, EPA considered the four factors specifically identified
in TSCA section 5(a)(2) and relevant information about the toxicity of
the chemical substances, and potential human exposures and
environmental releases that may be associated with the substances.
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
In those instances where EPA is proposing to expand the scope of a
significant new use or identify an additional significant new use, the
Agency identified concerns, as discussed in Unit III.C, associated with
certain potential new uses. EPA considered the factors discussed in
Unit II.A, and EPA determined that uses of concern could result in
changes in the type or form of exposure to the chemical substance,
increased exposures to the chemical substance, and/or changes in the
reasonably anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of the chemical substance.
In those instances where EPA is proposing to narrow the scope of a
significant new use, EPA has (1) received significant new use or
premanufacture notices for some of the activities designated as
significant new uses of the substance and, after reviewing such
notices, concluded that there is no need to require additional notice
from persons who propose to engage in identical or similar activities;
or (2) received test data or other information that led the Agency to
conclude that certain activities designated as significant new uses are
not likely to present an unreasonable risk of injury to health or the
environment.
2. Objectives
EPA proposes SNURs because the Agency has determined it is
appropriate:
<bullet> To have an opportunity to review and evaluate data
submitted in a SNUN before the submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
<bullet> To 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 the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under 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 at <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
C. Significant New Uses Claimed as CBI
The SNURs that EPA is proposing to modify include 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 or 40 CFR part 725, subpart C (for microorganisms). Absent a
final determination or other
[[Page 48719]]
disposition of the confidentiality claim under 40 CFR part 2
procedures, EPA is required to keep this information confidential. EPA
promulgated a procedure to deal with the situation where a specific
significant new use or specific chemical identity is CBI, at 40 CFR
721.11.
Under these procedures a manufacturer or processor may request EPA
to identify the confidential 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. If EPA concludes that
the person has shown a bona fide intent to manufacture or process the
chemical substance, EPA will identify the confidential significant new
use to that person. Since some of the specific chemical identities of
the chemical substances subject to these SNURs are also CBI,
manufacturers and processors may similarly request EPA to determine
whether a chemical substance is subject to these SNURs, and can combine
the bona fide submission for confidential significant new use and
specific chemical identity under the procedure in 40 CFR 721.11 into a
single step.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A
and (for microorganisms) 40 CFR part 725, subpart L. These provisions
describe persons subject to SNURs, recordkeeping requirements,
exemptions to reporting requirements, and applicability of the rule to
uses occurring before the effective date of the rule. Pursuant to 40
CFR 721.1(c) or 725.900(b) (for microorganisms), persons subject to
SNURs must comply with the same requirements and EPA regulatory
procedures as submitters of PMNs (or MCANs) 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), 5(h)(2), 5(h)(3), and
5(h)(5) and the regulations at 40 CFR part 720 or part 725 (for
microorganisms). In addition, provisions relating to user fees appear
at 40 CFR part 700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the significant new use of the chemical substance 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.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also <a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. For one of the SNURs addressed in this proposed rule,
EPA is proposing to designate as a ``significant new use'' additional
uses that are not currently specifically designated as a significant
new use under the SNURs, but which would be designated as a significant
new use requiring notification if this proposed rule is finalized. EPA
solicits comments on whether any of these uses are ongoing. These
specific significant new uses are:
<bullet> For the SNUR at 40 CFR 721.10471, (1) use without personal
protective equipment when workers are dermally exposed to the chemical
substance; (2) use without a National Institute for Occupational Safety
and Health (NIOSH)-certified respirator with an assigned protection
factor (APF) of at least 50 when workers are exposed by inhalation to
the chemical substance; (3) manufacture of the chemical substance in
any manner that results in inhalation exposure; (4) release of the
chemical substance resulting in surface water concentrations that
exceed 11 ppb; (5) use of the chemical substance in a consumer product;
and (6) use of the chemical substance without establishing a hazard
communication program.
EPA will not determine that a use is a ``significant new use'' if
information reasonably available to the Agency, including that received
during the period for public comment, establishes that the use is
ongoing at the time the proposed rule is published in the Federal
Register. It is therefore incumbent on any entity who believes they
have an ongoing use to inform EPA of that fact during the comment
period for a proposed SNUR. If a use that was not identified during the
comment period is subsequently demonstrated to have been ongoing at the
time the proposed rule was published, such information should be
brought to EPA's attention immediately.
Persons who begin manufacture or processing of the chemical
substances for a significant new use identified on or after the
designated cutoff date specified in Unit III.A. would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and EPA would have to take
action under TSCA section 5 allowing manufacture or processing to
proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
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 <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, 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 or reasonably ascertainable by
them (see 40 CFR 720.50 or 40 CFR 725.160 [for microorganisms]).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing. To assist with EPA's analysis of the SNUN,
submitters are encouraged, but not required, to provide the potentially
useful information identified for the chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to
consult
[[Page 48720]]
with the Agency pertaining to protocol selection. Furthermore, pursuant
to TSCA section 4(h), which pertains to reduction of testing in
vertebrate animals, EPA encourages consultation with the Agency on the
use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
The potentially useful information described in Unit III. may not
be the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA sections 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Significant New Use Rule
Amendments and Proposed Changes
A. What is the designated cutoff date for determining whether the new
use is ongoing for these chemical substances?
EPA designates October 28, 2025 as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
<bullet> CFR citation for the existing SNUR that EPA is proposing
to amend.
<bullet> PMN (or MCAN) and SNUN number(s), as applicable.
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
<bullet> Federal Register citation(s) for the previously issued
final rules(s).
<bullet> Basis for the proposed amendment.
C. Which chemical substances are subject to the proposed amendments?
The substances subject to the proposed amendments presented in this
document are as follows:
CFR citation: 40 CFR 721.1725.
PMN and SNUN number(s): P-82-438.
Chemical name: Benzoic acid, 3,3'-methylenebis [6 amino-, di-2-
propenyl ester.
CASRN: 61386-02-5.
Final rule FR citation(s): May 6, 1986 (51 FR 16687) (FRL-2926-9).
Basis for the proposed amendment: Certain new chemical SNURs have a
significant new use designation that is based on confidential business
information (CBI) in a PMN or other TSCA section 5 notice and
therefore, not disclosed in the published SNUR. In the Federal Register
of May 6, 1986 (51 FR 16687), EPA promulgated a procedure at 40 CFR
721.1725(b)(1) under which a manufacturer or processor could request
that EPA determine whether a specific use would be a significant new
use under the rule. The procedure required a manufacturer or processor
to establish a bona fide intent to manufacture or process the chemical
substance and to identify the specific use for which it intended to
manufacture or process the chemical substance. Many subsequent SNURs
with confidential significant new uses include a cross-reference to the
provisions of 40 CFR 721.1725(b)(1).
In the Federal Register of July 5, 2022 (87 FR 39756) (FRL-5605-02-
OCSPP), EPA finalized updates to the regulations governing significant
new uses of chemical substances under TSCA. This rule modified the
existing bona fide procedure for CBI chemical identities in 40 CFR
721.11 to apply to all SNURs containing any CBI, including the
significant new use. Accordingly, the previous procedure at 40 CFR
721.1725(b)(1) is now obsolete and unnecessary. EPA is proposing to
amend this SNUR to replace the bona fide procedure at paragraph (b)(1)
with a statement directing readers to the updated regulations at 40 CFR
721.11.
Potentially useful information: None.
CFR citation: 40 CFR 721.2076.
PMN and SNUN number(s): P-00-7, SN-5-1, SN-06-4, SN-07-3, SN-07-5.
Chemical name: D-Glucuronic acid, polymer with 6-deoxy-L-mannose
and D-glucose, acetate, calcium magnesium potassium sodium salt.
CASRN: 595585-15-2.
Final rule FR citation(s): December 17, 2003 (80 FR 37165) (FRL-
9928-93).
Basis for the proposed amendment: The proposed amendment to the
SNUR would amend the CASRN of the chemical substance from 125005-87-0
to 595585-15-2. The change was agreed upon between EPA and the PMN
submitter in order to incorporate sufficient information to adequately
and uniquely identify the polysaccharide gum produced by the
fermentation of a particular bacteria.
Potentially useful information: None.
CFR citation: 40 CFR 721.10070.
PMN and SNUN number(s): P-05-309, SN-13-4.
Chemical name: 1,3-Butanediol, 3-methyl-.
CASRN: 2568-33-4.
Final rule FR citation(s): September 19, 2007 (72 FR 53483) (FRL-
8135-8).
Basis for the proposed amendment: P-05-309 states that the PMN
substance will be used as an inkjet ink. Based on test data on the PMN
substance and on analogous chemicals, EPA predicted concerns for
developmental toxicity, liver toxicity, blood/immune system effects and
possibly digestive tract and kidney effects. EPA did not determine that
the proposed processing or use of the substance may present an
unreasonable risk. EPA did determine, however, that domestic
manufacture or use of the substance other than as described in the PMN
may cause serious health effects. Based on this information, the PMN
substance met the concern criteria at Sec. 721.170(b)(1)(i)(C),
(b)(3)(ii), and (b)(4)(ii). On September 19, 2007, EPA issued a SNUR
for P-05-309 which included the following significant new uses:
domestic manufacture and use other than the use in the PMN.
On January 30, 2013, EPA received SNUN S-13-4 for use as a fixing
agent of ink for inkjet printers. EPA determined that the new use will
not present an unreasonable risk of injury to human health. The
proposed amendment to the SNUR would remove use as a fixing agent of
ink for inkjet printers from the scope of the significant new use and
would require notification for any uses not listed in the SNUR or PMN.
Potentially useful information: EPA has determined that certain
information may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
this SNUR. EPA has determined that the results of developmental or
chronic toxicity testing may be potentially useful to characterize the
health effects of the substance.
CFR citation: 40 CFR 721.10471.
[[Page 48721]]
PMN and SNUN number(s): P-03-622, SN-17-5, SN-20-7, SN-21-4, SN-23-
7.
Chemical name: 2-Propenoic acid, 1,1'-(3-methyl-1,5-pentanediyl)
ester.
CASRN: 64194-22-5.
Final rule FR citation(s): September 21, 2012 (77 FR 58698) (FRL-
9357-2).
Basis for the proposed amendment: P-03-622 states that the generic
(non-confidential) use of the substance will be as a component of a UV
coating agent. For P-03-622, based on structure activity relationships
(SAR) analysis of test data on analogous acrylates, EPA identified
concerns for oncogenicity, mutagenicity, sensitization, irritation to
membranes, and developmental toxicity. In addition, based on Ecological
Structure Activity Relationships (EcoSAR) analysis of test data on
analogous acrylates, EPA predicted toxicity to aquatic organisms may
occur if releases of the substance to surface waters, from uses other
than as described in the PMN, exceed releases from the assessed use
described in the PMN. As stated in the PMN, the substance will be
imported and not manufactured in the United States. For the use
identified in the PMN, significant worker exposures are not expected
during processing and use activities and significant environmental
releases are not expected. Therefore, EPA did not determine that the
proposed processing or use of the substance may present an unreasonable
risk. EPA determined, however, that domestic manufacture or use of the
substance other than as described in the PMN may cause serious health
effects and significant adverse environmental effects. Based on this
information, the PMN substance met the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). On September 21, 2012,
EPA issued a SNUR for P-03-622 which included the following significant
new uses: domestic manufacture and use other than as described in the
PMN (generically, use as a component of a UV coating agent). EPA also
recommended certain human health and environmental toxicity testing in
the SNUR.
On January 27, 2017, EPA received SNUN SN-17-5 for use as a monomer
used in production of UV curable coatings and printing inks. After
review of SN-17-5, information available to EPA indicated that there is
a potential for human or environmental exposure to the SNUN substance,
that the SNUN substance may present a risk to workers exposed via the
dermal route for irritation, sensitization, and other toxicological
endpoints, and the SNUN substance may present a risk to aquatic
organisms if released to water in sufficient quantity. On August 2,
2017, EPA issued an Order for SN-17-5 under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. The submitter of SN-17-5 is subject to the
following Order requirements:
<bullet> Submittal to EPA of certain human health and environmental
toxicity testing before manufacturing (including import) a total of
61,000 kilograms of the substance;
<bullet> Use of a NIOSH-certified full-facepiece respirator with an
APF of at least 50 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment including impervious
gloves where there is a potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary, statements on each label and in the SDS;
<bullet> No release of the substance, or any waste stream
containing the substance, resulting in surface water concentrations
that exceed 1 part per billion (ppb);
<bullet> Use the substance only as a monomer for use in production
of UV curable coatings and printing inks; and
<bullet> Manufacture of the substance only by import into the
United States (i.e., no domestic manufacture).
On July 21, 2020, EPA received SNUN SN-20-7 for domestic
manufacturing and use as a component of UV curable coatings and
printing inks. After review of SN-20-7, information available to EPA
indicates that there is a potential for human or environmental exposure
to the SNUN substance and that the SNUN substance may present a risk to
workers exposed via the dermal route for local dermal effects and skin
sensitization, may present a risk to workers exposed via the inhalation
route for irritation, sensitization and respiratory effects, and may
present risk to aquatic organisms from chronic exposure to the
environment based on the chronic COC of 12 ppb being during use.
Therefore, EPA determined according to TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I) that the new uses may present an unreasonable
risk to human health and that an Order was required to protect against
those risks. On September 18, 2023, EPA issued an Order for SN-20-7
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. The submitter of SN-20-7
and the submitter's two confidential joint submitters are subject to
the following Order requirements:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> No release of the substance resulting in surface water
concentrations that exceed 12 ppb;
<bullet> No use of the substance in a consumer product;
<bullet> No use of the substance other than as a component of UV
curable coatings and printing inks or for the additional confidential
use listed in the Order; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements, on each label and in the SDS.
The submitter of SN-20-7 and the submitter's two confidential joint
submitters are permitted to manufacture the substance domestically in
accordance with the requirements listed above.
On March 31, 2021, EPA received SNUN SN-21-4 for the generic use as
a monomer. Based on submitted test data on the substance, information
provided in the SDS, and comparison to analogous chemical substances,
EPA has identified concerns for acute inhalation toxicity; irritation
to eyes, skin, and respiratory tract; skin sensitization; systemic
effects; and developmental effects. Based on physical/chemical
properties of the substance, EPA also identified concerns for
aspiration hazard. Based on the bifunctional reactive groups (terminal
alkenes) indicating potential for protein crosslinking, EPA has also
identified concerns for respiratory sensitization. Based on comparison
to analogous acrylates and methacrylates, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 12 ppb. On
August 16, 2022, EPA issued an Order for SN-21-4 under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. The submitter of SN-21-4 is subject to the
following Order requirements:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
[[Page 48722]]
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> No release of the substance resulting in surface water
concentrations that exceed 12 ppb;
<bullet> No use of the substance in a consumer product;
<bullet> No use of the substance other than for the confidential
use listed in the Order; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements, on each label and in the SDS.
On January 9, 2023, EPA received SNUN SN-23-7 for use as a
component of UV curable coatings and printing inks, manufacturing
additive, adhesives, composites, 3D printing, and coating systems.
Based on test data on the substance and information provided in the
SDS, EPA has identified concerns for acute inhalation toxicity;
irritation to eyes, skin, and respiratory tract; skin sensitization;
systemic effects; and developmental effects. Based on analogous data,
EPA also identified concerns for respiratory effects. Based on the
bifunctional reactive groups, EPA identified concerns for respiratory
sensitization. Based on acute and chronic toxicity data on the SNUN
substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 11 ppb. On July 19, 2024, EPA issued an
Order for SN-23-7 under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. The
submitter of SN-23-7 is subject to the following Order requirements:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> No manufacture in any manner that results in inhalation
exposure to the substance;
<bullet> No release of the substance resulting in surface water
concentrations that exceed 11 ppb;
<bullet> No use of the substance in a consumer product;
<bullet> No use of the substance other than for use as a component
of UV curable coatings and printing inks, additive manufacturing,
adhesives, composites, 3D printing, and coating systems; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed amendment to the SNUR would remove domestic
manufacture and use of the substance other than as described in PMN P-
03-622 (including a confidential use) from the significant new uses,
allowing these conditions of use to occur without notification to EPA.
The proposed amendment would instead designate the following activities
as significant new uses: (1) use without worker personal protective
equipment for dermal protection; (2) use without worker PPE of a NIOSH-
certified respirator with an APF of at least 50; (3) use of the
chemical substance without establishing a hazard communication program;
(4) release of the chemical substance to water resulting in surface
water concentrations that exceed 11 ppb; (5) manufacture of the
chemical substance in any manner that results in inhalation exposure;
(6) use other than as a component of UV curable coatings and printing
inks, additive manufacturing, adhesives, composites, 3D printing, and
coating systems; and (7) use of the chemical substance in a consumer
product. Additionally, the amendment would add an exemption from the
SNUR requirements when the substance has been completely reacted or
cured.
Potentially useful information: EPA has determined that certain
information may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
this SNUR. EPA has determined that the results of aquatic toxicity
testing may be potentially useful to characterize the environmental
effects of the SNUN substance.
CFR citation: 40 CFR 721.10966.
PMN and SNUN number(s): P-14-260.
Chemical name: 1-Propene, 2-bromo-3,3,3-trifluoro-.
CASRN: 1514-82-5.
Final rule FR citation(s): September 21, 2017 (82 FR 44093) (FRL-
9959-81).
Basis for the proposed amendment: P-14-260 states that the
substance will be used as a fire extinguishing agent for: portable
extinguishers (onboard aviation and all nonresidential); niche systems
(aircraft, normally unoccupied systems, self-contained automatic fire
extinguishing systems); and streaming systems for aircraft rescue fire
fighting vehicles. Based on test data on the PMN substance, EPA
identified concerns for reproductive effects for unprotected workers
from repeated inhalation exposures. An Order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that
the substance may present an unreasonable risk of injury to human
health and the environment. The submitter of P-14-260 was subject to
the following Order requirements:
<bullet> Manufacture of the substance only by import into the
United States (i.e., no domestic manufacture);
<bullet> Use of personal protective equipment including a National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10 or
compliance with a new chemical exposure limit (NCEL) of 1.0 parts per
million (ppm) as an 8-hour time-weighted average, when there is a
potential for inhalation exposures;
<bullet> Establishment and use of a hazard communication program,
including human health precautionary statements, on each label and in
the Safety Data Sheet (SDS);
<bullet> Processing (including filling of hand-held fire
extinguishers or fire extinguishing systems) of the PMN substance only
in an enclosed process; and
<bullet> Use only as either (1) total flooding agent in unoccupied
spaces, specifically engine nacelles and auxiliary power units (APUs)
in aircraft; or (2) streaming fire extinguishing agent for use only in
handheld extinguishers in aircraft.
On September 21, 2017, EPA issued a SNUR designating significant
new uses based on and consistent with the Order requirements.
On April 20, 2018, EPA received a request from the PMN submitter to
modify the Order to allow two additional uses: streaming in all non-
residential uses (except for commercial home office and personal
watercraft), and niche flooding application for unoccupied spaces, such
as ``not normally occupied volumes'' up to 500 ft\3\ (e.g., large data
storage rooms). EPA assessed exposures from the proposed new uses and
determined that exposures and risk--i.e., acceptable risks, except for
filling of canisters, which is controlled under the original Order--
from the proposed new uses are the same as for the original uses
identified in P-14-260. As a result, EPA modified the Order.
Accordingly, the proposed amendment to the SNUR would reduce the scope
of the significant new uses to exclude the two additional uses.
Potentially useful information: EPA has determined that certain
information may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
this SNUR. EPA has determined that inhalation monitoring data,
collected according to EPA's draft Inhalation
[[Page 48723]]
Monitoring Data Collection Guidelines (available in the docket for this
rulemaking), may be potentially useful to characterize the human health
effects of the substance.
CFR citation: 40 CFR 721.11180.
PMN and SNUN number(s): P-17-283.
Chemical name: Arenesulfonic acid, alkyl derivatives, metal salts
(generic).
CASRN: Not Available.
Final rule FR citation(s): December 5, 2019 (84 FR 66596) (FRL-
10001-47).
Basis for the proposed amendment: P-17-283 states that the
substance will be used as a lubricating oil additive for automotive
engine oils. Based on analysis of test data on the substance, EPA
identified a concern for corrosion to skin, eyes, mucous membranes, and
lungs. There are also concerns for surfactant effects on the lung based
on surfactant properties of the compounds and for acute toxicity,
mutagenicity, irritation, and sensitization based on submitted analogue
test data. An Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health and the
environment. The Order was also issued under TSCA sections
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the
substance is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. The
submitter of P-17-283 is subject to the following Order requirements:
<bullet> Submittal to EPA of certain toxicity testing within six
months of filing a notice of commencement (NOC) to EPA;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
<bullet> No manufacture, processing, or use of the substance in any
manner that produces a vapor, mist, spray or aerosol.
The Order also prohibited the company from manufacturing the
substance six months after filing a notice of commencement with the EPA
unless the company conducts sensitization testing. On December 5, 2019,
EPA issued a SNUR designating significant new uses based on and
consistent with the Order requirements.
On September 14, 2018, the PMN submitter submitted the results of
sensitization testing conducted as required by the Order. EPA
concluded, upon review of the test data, that the substance is a
sensitizer. On January 23, 2020, EPA received a request from the PMN
submitter to revise the SNUR to remove the significant new use
requiring notification for manufacture of the substance beyond 6 months
because the Local Lymph Node Assay was completed on the PMN substance.
The proposed amendment to the SNUR would remove this significant new
use.
Potentially useful information: EPA has determined that certain
information may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
this SNUR. EPA has determined that the results of physical-chemical
properties and acute and chronic pulmonary toxicity testing may be
potentially useful to characterize the health effects of the substance.
CFR citation: 40 CFR 725.1080.
MCAN number: J-19-1.
Chemical name: Trichoderma reesei (generic).
CASRN: Not Available.
Final rule FR citation(s): April 30, 2021 (86 FR 22875) (FRL-10016-
30).
Basis for the proposed amendment: EPA included references to 40 CFR
part 721 sections 125 and 185 in the SNUR for this microorganism.
Equivalent sections exist in the regulations under part 725 which are
more appropriate for SNURs for microorganisms. The proposed amendment
would modify the SNUR to reference the recordkeeping requirements
specified at 725.950(b)(2) through (4) (rather than 721.125(a) through
(c)) and the provisions of 725.984 (rather than 721.185). The proposed
amendment would also require recordkeeping to document compliance with
applicable limitations in paragraph (a)(2) of the SNUR rather than the
requirement to keep records as described in 721.125(i).
Potentially useful information: None.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action proposes to modify SNURs for chemical substances that
were the subject of PMNs or MCANs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866 (58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because a significant new use rule for a chemical under TSCA section 5
is exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The 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.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. 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.
EPA always welcomes your feedback on the burden estimates. When
submitting comments on these proposed SNURs, include comments about the
accuracy of the burden estimate, and any suggested methods for
improving the collection instruments or instruction or minimizing
respondent burden, including through the use of automated collection
techniques.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). 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
[[Page 48724]]
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 9 in fiscal year FY2022, 23 in FY2023, and
7 in FY2024, and only a fraction of these submissions was from small
businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs 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 SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to 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. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the intended uses to identify potential risks and
take appropriate actions before the activities commence.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
List of Subjects in 40 CFR Part 721 and 725
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 21, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, EPA proposes to amend 40
CFR chapter I as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Amend Sec. 721.1725 by revising paragraph (b) to read as follows:
Sec. 721.1725 Benzoic acid, 3,3'-methylenebis [6-amino-, di-2-
propenyl ester.
(a) * * *
(1) * * *
(2) * * *
(b) * * *
(1) Determining whether a specific use is subject to this rule. The
provisions of Sec. 721.11 apply to paragraph (a)(1) of this section
and to chemical substances which are subject to a significant new use
rule in subpart E of this part.
(2) * * *
0
3. Amend Sec. 721.2076 by revising paragraph (a)(1) to read as
follows:
Sec. 721.2076 D-Glucuronic acid, polymer with 6-deoxy-L-mannose and
D-glucose, acetate, calcium magnesium potassium sodium salt.
(a) * * *
(1) The chemical substance identified as D-glucuronic acid, polymer
with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium
potassium sodium salt (PMN P-00-7; SNUNs S-05-1, S-06-4, S-07-03, and
S-07-5; CAS No. 595585-15-2) is subject to reporting under this section
for the significant new use described in paragraph (a)(2) of this
section.
(2) * * *
(i) * * *
(ii) * * *
(b) * * *
(1) * * *
(2) * * *
0
4. Amend Sec. 721.10070 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
[[Page 48725]]
Sec. 721.10070 1,3-Butanediol, 3-methyl-.
(a) * * *
(1) The chemical substance identified as 1,3-butanediol, 3-methyl-
(PMN P-05-309; SNUN S-13-4; CAS No. 2568-33-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) * * *
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f). It is a significant new use to use
the substance other than as inkjet ink or as a fixing agent of ink for
inkjet printers.
(ii) * * *
(b) * * *
(1) * * *
(2) * * *
0
5. Revise and republish Sec. 721.10471 to read as follows:
Sec. 721.10471 2-Propenoic acid, 1,1'-(3-methyl-1,5-pentanediyl)
ester.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as 2-propenoic acid, 1,1'-(3-
methyl-1,5-pentanediyl) ester (PMN P-03-622; SNUNs S-17-5, S-20-7, S-
21-4, and S-23-7; CAS No. 64194-22-5) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the chemical 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), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity
(inhalation only), skin irritation, eye irritation, respiratory
sensitization, skin sensitization, specific target organ toxicity, and
aspiration hazard. Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture the substance in any manner that results in inhalation
exposure to the substance. It is a significant new use to use the
substance other than as a component of UV curable coatings and printing
inks, additive manufacturing, adhesives, composites, 3D printing, and
coating systems.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=11.
(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
(including importers) and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Amend Sec. 721.10966 by revising paragraphs (a)(2)(iii) to read as
follows:
Sec. 721.10966 1-Propene, 2-bromo-3,3,3-trifluoro-.
(a) * * *
(1) * * *
(2) * * *
(i) * * *
(A) * * *
(1) * * *
(2) * * *
(3) * * *
(4) * * *
(5) * * *
(B) * * *
(ii) * * *
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(c) and (f). It is a significant new use to
use the substance other than as a fire extinguishing agent as a total
flooding agent in unoccupied spaces, specifically engine nacelles and
auxiliary power units (APUs) in aircraft; as a streaming fire
extinguishing agent for use only in handheld extinguishers in aircraft;
streaming in all non-residential uses, except for commercial home
office and personal watercraft; or niche flooding application for
unoccupied spaces, such as ``not normally occupied volumes'' up to 500
ft\3\ (e.g., large data storage rooms).
(b) * * *
(1) * * *
(2) * * *
0
7. Amend Sec. 721.11180 by revising paragraph (a)(2)(iii) to read as
follows:
Sec. 721.11180 Arenesulfonic acid, alkyl derivatives, metal salts
(generic).
(a) * * *
(1) * * *
(2) * * *
(i) * * *
(ii) * * *
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in the generation of a vapor, mist, spray, or
aerosol.
(b) * * *
(1) * * *
(2) * * *
PART 725--SIGNIFICANT NEW USES OF MICROORGANISMS
0
8. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
9. Amend Sec. 725.1080 by revising paragraphs (b)(1) and (2) to read
as follows:
Sec. 725.1080 Trichoderma reesei (generic).
(a) * * *
(1) * * *
(2) * * *
(i) * * *
(ii) * * *
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) and a requirement to maintain records
documenting compliance with limitations in paragraph (a)(2) 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. 2025-19673 Filed 10-27-25; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on October 28, 2025.
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