[Federal Register Volume 90, Number 210 (Monday, November 3, 2025)]
[Proposed Rules]
[Pages 49148-49177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19756]
[[Page 49147]]
Vol. 90
Monday,
No. 210
November 3, 2025
Part III
Environmental Protection Agency
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40 CFR Part 721
Significant New Use Rules on Certain Chemical Substances (24-5.5e);
Proposed Rule
Federal Register / Vol. 90, No. 210 / Monday, November 3, 2025 /
Proposed Rules
[[Page 49148]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0281; FRL-12742-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
5.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs) and are also
subject to an Order issued by EPA pursuant to TSCA. 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 proposed as a significant new use by this rulemaking to notify
EPA at least 90 days before commencing that activity. The required
notification initiates EPA's evaluation of the conditions of that use
for that chemical substance. In addition, the manufacture or processing
for the significant new use may not commence until EPA has conducted a
review of the required notification, made an appropriate determination
regarding that notification, and taken such actions as required by that
determination.
DATES: Comments must be received on or before December 3, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0281, online at https://www.regulations.gov. 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Andrew Sullivan, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 565-0605; email address:
[email protected].
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:
[email protected].
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: [email protected].
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.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in
Unit III. These SNURs, if finalized as proposed, would require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
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:
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
(https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40
CFR part 707, subpart B. Importers of chemical substances in bulk form,
as part of a mixture, or as part of an article (if required by rule)
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, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after December 3, 2025 are subject to 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?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
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
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)). 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
[[Page 49149]]
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 https://www.regulations.gov. If you wish to include CBI in your comment, please
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov//epa-dockets.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
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:
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 the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs 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). The TSCA orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed 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).
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.
During review of the PMNs submitted that are subject to these
proposed SNURs, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. Based on these findings outlined in Unit III.,
TSCA section 5(e) Orders requiring the use of appropriate exposure
controls were negotiated with the PMN submitters. As a general matter,
EPA believes it is necessary to follow the 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.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying TSCA Orders,
consistent with TSCA section 5(f)(4).
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.
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 proposed 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 https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR parts 2 and 703. Absent a final determination or other
disposition of the confidentiality claim under these regulations, EPA
is required to keep this information confidential. EPA promulgated a
procedure at 40 CFR 721.11 to deal with the situation where a specific
significant new use is CBI. Under these procedures, a manufacturer or
processor may ask EPA to identify the confidential significant new use
subject to the SNUR. 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
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.
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D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
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), persons subject to SNURs must comply with
the same 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),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
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 https://www.epa.gov/tsca-import-export-requirements.
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. The chemical substances subject to this proposed rule
have undergone premanufacture review and received determinations under
TSCA section 5(a)(3)(C). TSCA Orders have been issued for these
chemical substances and the PMN submitters are required by the TSCA
Orders to submit a SNUN before undertaking activities that would be
designated as significant new uses in these SNURs. Additionally, the
identities of many of the chemical substances subject to this proposed
rule have been claimed as confidential per 40 CFR 720.85, further
reducing the likelihood that another party would manufacture or process
the substances for an activity that would be designated as a
significant new use. Based on this, the Agency believes that it is
highly unlikely that any of the significant new uses identified in Unit
III. are ongoing.
When the chemical substances identified in Unit III 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. 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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
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). 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 as identified
for the chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). 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 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 that provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates November 3, 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:
[[Page 49151]]
PMN number (the proposed CFR citation assigned in the
regulatory text section of the proposed rule).
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service Registry Number (CASRN) or
Accession Number (if assigned for confidential chemical identities).
Basis for the SNUR (effective date of and basis for the
TSCA Order).
Potentially useful information.
The regulatory text section of the proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
These proposed SNURs 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 proposed 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.
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are
as follows, listed by PMN number and with the proposed CFR citation.
P-18-281 and P-21-77 (40 CFR 721.12147)
Chemical name: Cyclic sulfate (generic) (P-18-281 and P-21-77).
CASRN: Not available.
Effective dates of TSCA Orders: January 4, 2025 (P-18-281 Modified
Order for SoulBrain MI, Inc.) and April 26, 2022 (P-18-281 joint
submitters and P-21-77).
Basis for action: PMN P-18-281 states that the generic (non-
confidential) use will be as an electrolyte additive. Based on test
data on the PMN substance and comparison to analogous substances, EPA
identified concerns for genetic toxicity, skin sensitization,
carcinogenicity, systemic effects, corrosion to the skin, eyes, and
respiratory tract, and acute toxicity. Based on comparison to analogous
substances, EPA also identified concerns for systemic and
carcinogenicity effects for the hydrolysis product. Based on comparison
to analogous neutral organic substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 152 ppb. EPA
issued Orders for the PMN submitter and joint submitters 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. To protect against these risks, the
Orders require:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate or combination
particulate and gas/vapor respirator with an APF of at least 50 (where
there is a potential for inhalation exposure) if the PMN submitter uses
only up to the confidential annual production volume (measured on a
year-to-year basis) at a use site and receives the PMN substance at 1%
or less in formulation; or, if these conditions are not met, an APF of
at least 1,000;
No domestic manufacture of the PMN substance (i.e., import
only);
Processing only at SoulBrain MI, Inc.'s Northville, MI
facility;
No processing of the PMN substance above 5% in
formulation;
No processing or use of the PMN substance other than for
the confidential use allowed in the Order;
No release of more than 8.3 kg/year of the PMN substance
in the form of dust stack air releases;
No disposal of the PMN substance by incineration unless
the PMN substance has been fully reacted with water or when using a
hazardous waste incinerator with >=99.999% efficiency;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 152 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
These Orders, effective April 26, 2022, required the PMN submitters
to process the PMN substance at SoulBrain MI, Inc.'s facility in
Northville, MI, among the other restrictions identified above.
On June 2, 2023, SoulBrain MI, Inc. requested a modification of
their Order to allow processing of the PMN substance both at SoulBrain
MI, Inc.'s facility in Northville, MI and at their new facility in
Kokomo, IN. EPA performed a risk assessment based on the new intended
conditions of use and subsequently modified the terms of their Order to
mitigate any unreasonable risks to human health and the environment and
issued a modified Order, effective January 4, 2025. To protect against
these risks, the modified Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Prior to conducting exposure monitoring as described in
the modified Order, use of a NIOSH-certified particulate or combination
particulate and gas/vapor respirator with an APF of at least 50 (where
there is a potential for inhalation exposure) if: (1) the PMN submitter
uses only up to the confidential volume specified in the modified Order
of the PMN substance at the PMN submitter's Northville, MI site and
receives the PMN substance at 1% or less in formulation, or (2) the PMN
submitter uses up to the confidential volume specified in the modified
Order of the PMN substance at the PMN submitter's Kokomo, IN site and
receives the PMN substance at 1% or less in formulation; or, if these
conditions are not met, an APF of at least 1,000;
After conducting exposure monitoring as described in the
modified Order, use of a NIOSH-certified respirator with an appropriate
APF based on the results of the exposure
[[Page 49152]]
monitoring described in the modified Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Processing only at SoulBrain MI, Inc.'s Northville, MI and
Kokomo, IN facilities;
No processing of the PMN substance above 5% in
formulation;
No processing or use of the PMN substance other than for
the confidential use allowed in the modified Order;
No release of more than 8.3 kg/year (measured on a year-
to-year basis) of the PMN substance in the form of dust air releases at
SoulBrain MI, Inc.'s Northville, MI facility;
No dust air releases of the PMN substance at SoulBrain MI,
Inc.'s Kokomo, IN facility;
No release of the PMN substance to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
On February 3, 2021, EPA received a second PMN, P-21-77, for the
same substance due to the fact that the review of PMN P-18-281 had not
been completed and the substance had not been added to the TSCA
Inventory. PMN P-21-77 states that the generic (non-confidential) use
will be as a battery additive. Based on the test data on the PMN
substance and comparison to analogous substances, EPA identified
concerns for mutagenicity, skin sensitization, carcinogenicity,
specific target organ toxicity and acute oral toxicity. Based on
comparison to analogous substances, EPA also identified concerns for
systemic and carcinogenicity effects for the hydrolysis product. Based
on comparison to analogous neutral organic substances, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
152 ppb. 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. To
protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate or combination
particulate and gas/vapor respirator with an APF of at least 1,000
where there is a potential for inhalation exposure;
No domestic manufacture of the PMN substance (i.e., import
only);
No manufacture of the PMN substance other than following
the confidential manufacturing restriction described in the Order;
Processing and use of the PMN substance only using the
confidential methods and engineering controls described in the PMN
submission;
No processing or use of the PMN substance other than for
the confidential use allowed in the Order;
No disposal of the PMN substance or waste streams
containing the PMN substance other than through the method(s) described
in the PMN, or by landfill, deep well injection, incineration (only if
the substance has been fully reacted with water or using a hazardous
waste incinerator with >=99.999% efficiency), or release to water as
allowed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 152 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of the following protective measures:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate or combination
particulate and gas/vapor respirator of at least 50 where there is a
potential for inhalation exposure if using only up to the confidential
annual production volume listed in the Order (measured on a year-to-
year basis) at a use site and receiving the PMN substance at 1% or less
in formulation; or, if these conditions are not met, an APF of at least
1,000;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No domestic manufacture of the PMN substance (i.e., import
only);
No processing or use of the PMN substance other than for
the confidential uses allowed in the Orders;
No processing of the PMN substance above 5% in
formulation;
No dust air releases of the PMN substance;
No disposal of the PMN substance or waste streams
containing the PMN substance other than through the confidential
method(s) described in the PMN P-21-77, or by landfill, deep well
injection, incineration (only if the substance has been fully reacted
with water or using a hazardous waste incinerator with >=99.999%
efficiency); and
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 152 ppb.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitters to modify the Orders, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity, specific target organ toxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Orders do not
require these tests, the Orders' restrictions remain in effect until
the Orders are modified or revoked by EPA based on submission of this
or other relevant information.
P-20-73 (40 CFR 721.12148)
Chemical name: 2,5-Furandione, reaction products with alkylamine,
1-octanol and polyethylene glycol alkoxy-ether, acetates (salts)
(generic).
CASRN: Not available.
Effective date of TSCA Order: September 3, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for oil and gas production chemistry. Based
on a structural alert for aliphatic amines, EPA has identified concerns
for irritation to the skin, eyes, and respiratory tract and potential
lung toxicity (cationic binding). Based on structural alerts for
anhydrides and diamines, EPA has identified concerns for respiratory
sensitization. Based on a structural alert for imides, EPA has
identified concerns for acute toxicity. Based on a structural alert for
cationic surfactants, EPA has identified concerns for lung toxicity
(surfactant effects) and irritation to the skin, eyes, and respiratory
tract. Based on a structural alert for polyethers and the structure of
the feedstock residual, EPA has identified additional concerns for lung
toxicity (surfactant effects). Based on a structural alert for acid
groups and test data for a feedstock residual, EPA has identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on test data for feedstock residuals, EPA has identified concerns for
acute toxicity, acute neurotoxicity, clinical signs, skin corrosion,
eye corrosion, skin sensitization, respiratory sensitization, and body
weight, portal-of-entry, lung, kidney, liver, blood, clinical
chemistry, spleen, and bladder effects. Based on comparison to
analogous alcohol ethoxylates, EPA has also identified concerns for
clinical signs and portal-of-
[[Page 49153]]
entry, developmental, liver, kidney, brain, heart, and thyroid effects.
Based on comparison to analogous aliphatic amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
160 ppb. The 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. To
protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 160 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, neurotoxicity, reproductive/developmental toxicity, eye
damage, skin corrosion, skin sensitization, pulmonary effects, specific
target organ toxicity, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-2 (40 CFR 721.12149)
Chemical name: Metal oxide chloride (generic).
CASRN: Not available.
Effective date of TSCA Order: September 17, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for the manufacturing of electronic devices.
Based on the release of hydrolysis products, EPA has identified
concerns for corrosion to the skin, eyes, and respiratory tract. Based
on test data on a hydrolysis product, EPA has also identified concerns
for lung effects, systemic effects, reproductive effects, and lung
carcinogenicity. The 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.
To protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure;
Manufacture of the PMN substance only below the
confidential annual production volume listed in the Order;
Manufacture and processing of the PMN substance only in a
sealed, inert atmosphere environment of a sealed drybox wherever
feasible. For activities performed outside of the drybox that may
generate dust or any exhaust to air, all streams must be treated with
caustic water control technology with a minimum of 90% destruction
efficiency.
Use of the PMN substance only for the confidential use
listed in the Order; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, skin corrosion, eye
damage, carcinogenicity, and reproductive toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-53 (40 CFR 721.12150)
Chemical name: Ethanol, 2-amino-, compds. with polyethylene glycol
hydrogen sulfate C10-16-alkyl ether.
CASRN: 157627-92-4.
Effective date of TSCA Order: July 10, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive in agricultural formulations.
Based on chemical structure, EPA has identified concerns for lung
effects (surfactancy). Based on comparison to analogous chemical
substances, EPA has also identified concerns for skin, eye, and
respiratory tract irritation, acute toxicity, skin sensitization, and
portal-of-entry (oral/irritation), systemic, and reproductive effects.
Based on information in the SDS, EPA has also identified concerns for
skin and eye irritation. Based on submitted test data on the PMN
substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 14 ppb. The 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. To protect against these risks, the
Order requires:
Use of the PMN substance only for the confidential use
listed in the PMN;
Use of personal protective equipment where there is a
potential for dermal exposure;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 14 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye irritation, pulmonary effects, reproductive toxicity,
skin irritation, skin sensitization, aquatic toxicity, and specific
target organ toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the
[[Page 49154]]
Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-22-114 (40 CFR 721.12151)
Chemical name: Edge oxidized carbon matrix (generic).
CASRN: Not available.
Effective date of TSCA Order: September 10, 2024.
Basis for TSCA additive Order: The PMN states that the generic
(non-confidential) use will be as an anode material and a corrosion
protection. Based on comparison to analogous chemical substances, EPA
has identified concerns for lung effects and systemic effects. EPA was
unable to estimate the environmental hazard of the PMN substance. The
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. To
protect against these risks, the Order requires:
Use of a NIOSH-certified respirator with an APF of at
least 10,000 where there is a potential for inhalation exposure or
compliance with a NCEL of 0.00733 mg/m\3\ as an 8-hour time-weighted
average to prevent inhalation exposure;
Manufacture of the PMN substance only below the
confidential annual production volume listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water;
Use of the PMN substance only for the confidential use
listed in the Order; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-22-123 (40 CFR 721.12152)
Chemical name: Propaneamine, 3-(alkyloxy)-, structural variants
(generic).
CASRN: Not available.
Effective date of TSCA Order: July 24, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a mineral processing aid. Based on
comparison to analogous chemical substances and information provided in
the SDS, EPA has identified concerns for acute toxicity, skin, eye, and
respiratory tract corrosion, portal-of-entry (oral), systemic effects,
and reproductive and developmental effects. Based on comparison to
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 6 ppb. The 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. To protect against these
risks, the Order requires:
Use of the PMN substance only for the confidential use
listed in the Order;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 6 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin corrosion, eye corrosion, specific target organ
toxicity, reproductive toxicity, developmental toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-22-124 (40 CFR 721.12153)
Chemical name: Propanenitrile, 3-(alkyloxy)-, structural variance
(generic).
CASRN: Not available.
Effective date of TSCA Order: July 24, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
site-limited intermediate. Based on comparison to analogous chemical
substances, data on residuals, a solvent, and a potential metabolite,
and information provided in the SDS, EPA has identified concerns for
acute toxicity, skin and eye irritation, skin sensitization,
neurotoxicity, genotoxicity, carcinogenicity, and systemic,
reproductive, and developmental effects. EPA calculated a drinking
water equivalent level (DWEL) of 45 ppb that is protective for these
effects. Based on comparison to analogous neutral organics, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 76 ppb. The 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. To protect against these risks, the Order
requires:
Use of the PMN substance only as a site-limited
intermediate;
No manufacture of the PMN substance with the confidential
residual feedstock listed in the Order present at greater than 1% by
weight;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 45 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has
[[Page 49155]]
determined that the results of skin irritation, skin sensitization,
genotoxicity, carcinogenicity, eye irritation, reproductive toxicity,
developmental toxicity, specific target organ toxicity, neurotoxicity,
acute toxicity, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-126 (40 CFR 721.12154)
Chemical name: Cellulose, polymer with 1,1'-[2-ethyl-2-[(3-
mercapto-1-oxopropoxy)methyl]-1,3-propanediyl] bis(3-
mercaptopropanoate) and 1,2,3-propanetriol bis(2-methyl-2-propenoate),
peroxydisulfuric acid ([(HO)S(O)2]2O2) ammonium salt (1:2)- and sodium
(disulfite) (2:1)-initiated.
CASRN: 2696236-02-7.
Effective date of TSCA Order: July 18, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
polymer for microcapsules containing fragrance that can be used in
different home-care and personal-care applications including fabric
conditioners, powders, and scent boosters. Based on the high molecular
weight, negligible water solubility, and inert properties of the PMN
substance, EPA has identified concerns for lung overload. The 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. To protect against these risks, the
Order requires:
No processing for use or use of the PMN substance in
consumer products where the concentration of the PMN substance exceeds
the confidential percentage by weight listed in the Order;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity and pulmonary effects testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-137 (40 CFR 721.12155)
Chemical name: Alkyl dialkylamine (generic).
CASRN: Not available.
Effective date of TSCA Order: August 22, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
intermediate for making quaternary ammonium salt. Based on comparison
to analogous chemical substances, EPA has identified concerns for acute
toxicity, skin corrosion, eye corrosion, respiratory irritation, and
portal-of-entry, systemic, and reproductive effects. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 110 ppb. The
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. To
protect against these risks, the Order requires:
No manufacture of the PMN substance above the confidential
annual production volume listed in the Order;
No manufacture, processing, or use of the PMN substance at
any facility not equipped with pollution controls with a destruction
efficiency of 99.98% or greater;
No use of the PMN substance other than as a chemical
intermediate for a quaternary ammonium salt;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration or deep well injection;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin irritation/corrosion, eye irritation/corrosion,
reproductive toxicity, pulmonary effects, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-138 (40 CFR 721.12156)
Chemical name: Tetraalkylammonium chloride (generic).
CASRN: Not available.
Effective date of TSCA Order: August 22, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
intermediate for making hydroxide salt. Based on comparison to
analogous chemical substances, EPA has identified concerns for acute
toxicity, skin and eye irritation, systemic, and neurotoxic effects.
Based on comparison to analogous chemical substances and dialkyl
quaternary cationic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 210 ppb. The 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. To protect against
these risks, the Order requires:
No manufacture, processing, or use of the PMN substance at
any facility not equipped with pollution controls with a destruction
efficiency of 99.98% or greater;
No use of the PMN substance other than as an intermediate
for making hydroxide salt;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
[[Page 49156]]
Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration or deep well injection;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, neurotoxicity, skin irritation, eye irritation, specific
target organ toxicity, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-185 (40 CFR 721.12157)
Chemical name: 1,3,5-Cycloheptatriene.
CASRN: 544-25-2.
Effective date of TSCA Order: June 21, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
chemical intermediate. Based on comparison to analogous chemical
substances, EPA has identified concerns for acute toxicity, skin, eye,
and respiratory tract irritation, respiratory tract corrosion, skin
sensitization, portal-of-entry effects, systemic effects, and solvent
narcosis-type effects. Based on comparison to analogous chemical
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 0.1 ppb. The 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 or the environment. To protect against these risks, the
Order requires:
Manufacture, processing, or use of the PMN substance only
when using engineering control measures that ensure that loading and
unloading of transport containers does not result in inhalation
exposures to the PMN substance;
Use of the PMN substance only as a chemical intermediate;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye irritation, skin irritation, skin sensitization, specific
target organ toxicity, pulmonary effects, and aquatic toxicity testing
may be potentially useful to characterize the health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-23-15 (40 CFR 721.12159)
Chemical name: Amines, polyalkylenepoly, (disubstitutedcarboxy)
derivs., alkali metal salts (generic).
CASRN: Not available.
Effective date of TSCA Order: August 20, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a water treatment chemical. Based on
submitted test data on the PMN substance, EPA has identified concerns
for skin irritation, systemic, reproductive, and developmental effects.
Based on measured pH data for the PMN substance, EPA has also
identified concerns for corrosion to the skin, eyes, and respiratory
tract. Based on comparison to analogous chemical substances and
hydrolysis products, EPA has also identified concerns for acute
toxicity, mortality, neurotoxicity, skin corrosion, eye corrosion, skin
sensitization, and portal-of-entry (oral), systemic, ocular,
reproductive, and developmental effects. Based on submitted test data
on the PMN substance, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 23 ppb. The 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. To protect against these
risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 23 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
corrosion, specific target organ toxicity, and aquatic toxicity testing
may be potentially useful to characterize the health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-23-30 (40 CFR 721.12160)
Chemical name: Phenol, polyalkylcarbo bis-, polymer with 2-
carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl]
ether (generic).
CASRN: Not available.
Effective date of modified TSCA Order: February 19, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymer of insulating materials. Based
on the physical/chemical properties of the PMN
[[Page 49157]]
substance (as described in the New Chemical Program's PBT category at
64 FR 60194, November 4, 1999 (FRL-6097-7)) and test data on
structurally similar substances, the PMN substance is a potentially
persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates
that the PMN substance will persist in the environment for more than
six months and estimates a bioaccumulation factor of greater than or
equal to 5,000. Based on potential formation of epoxides and the
potential for cross-linking, EPA has identified concerns for skin and
respiratory sensitization. Based on comparison with analogous chemical
substances, EPA has also identified concerns for acute toxicity
(inhalation route), skin, eye, and respiratory tract irritation,
pulmonary, neurological, reproductive, and systemic effects, genetic
toxicity, and carcinogenicity. EPA issued an Order, effective July 26,
2024, 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. To protect against these risks, the
Order requires:
Manufacture and processing of the PMN substance only in
liquid form;
No processing or use of the PMN substance in any manner
that results in inhalation exposure to the PMN substance;
Use of the PMN substance only for the confidential use
listed in the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
On January 13, 2025, EPA received a request from the PMN submitter
to modify the language in Written Agreement and Exemptions sections of
the Order. EPA approved the request and issued a modified Order,
effective February 19, 2025, replacing ``unless completely reacted and
cured'' with ``upon being dried to the extent that no release of the
New Chemical Substance can be detected.''
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, carcinogenicity, genotoxicity, reproductive toxicity,
pulmonary effects, skin sensitization, skin irritation, neurotoxicity,
eye irritation, and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-46 (40 CFR 721.12161)
Chemical name: Siloxanes and silicones, di-alkyl, hydroxy-
terminated, polymers with substituted alkane and substituted silane
(generic).
CASRN: Not available.
Effective date of TSCA Order: July 26, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a process aid for the fabrication of
molded articles. Based on comparison to analogous chemical substances,
the reactivity of the PMN substance and test data for a hydrolysis
product, EPA has identified concerns for acute toxicity and corrosion
to the skin, eyes, and respiratory tract. Based on the siloxane
structure of a hydrolysis product, EPA has also identified concerns for
lung toxicity (waterproofing). Based on test data for a hydrolysis
product, EPA has also identified concerns for acute toxicity, lung,
systemic, and reproductive effects. Based on comparison to analogous
chemical substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 570 ppb. The 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. To protect against these
risks, the Order requires:
Manufacture, processing, and use of the PMN substance only
in liquid solution formulation;
No processing for use or use of the PMN substance in a
consumer product;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye corrosion, skin corrosion, pulmonary effects,
reproductive toxicity, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-23-65 (40 CFR 721.12162)
Chemical name: Alkyl acid, 2[hyphen]hydroxy[hyphen], methyl
substituted alkyl ester (generic).
CASRN: Not available.
Effective date of TSCA Order: September 16, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an industrial process chemical. Based on
chemical structure, EPA has identified concerns for lung toxicity
(surfactancy). Based on comparison to analogous chemical substances and
test data on hydrolysis products and a metabolite, EPA has also
identified concerns for skin and respiratory tract irritation, eye
corrosion, clinical signs, neurotoxicity, systemic effects,
reproductive and developmental effects, and carcinogenicity. Based on
comparison to analogous esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 220 ppb. The 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. To protect against
these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
[[Page 49158]]
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 220 ppb;
Processing for use and use of the PMN substance only for
the confidential use listed in the Order; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity, developmental toxicity, eye irritation/corrosion,
neurotoxicity, pulmonary effects, skin irritation, specific target
organ toxicity, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-69 (40 CFR 721.12163)
Chemical name: Oils, Pisum sativum, polymers with 1,6-
diisocyanatohexane, 1,5-diisocyanatopentane, glycerol and maltodextrin.
CASRN: 3063505-38-1.
Effective date of TSCA Order: August 29, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
encapsulating shell polymer for fragrance encapsulates for industrial
or household consumer products such as detergents and fabric softeners.
Based on comparison to analogous chemical substances, EPA has
identified concerns for lung effects (i.e., lung fibrosis). The 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. To protect against these risks, the
Order requires:
No processing of the PMN substance for use in a consumer
product that can be spray applied;
No manufacture, processing, or use of the PMN substance in
any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substance; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-23-79 (40 CFR 721.12164)
Chemical name: Rosin, maleated, polymer with benzoic acid,
glycerol, propylene glycol and 3a,4,7,7a-tetrahydro-1,3-
isobenzofurandione.
CASRN: 2766660-60-8.
Effective date of TSCA Order: September 10, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a non-reactive resin to improve ink
performance. Based on comparison to analogous chemical substances and
information in the SDS, EPA has identified concerns for eye irritation,
skin sensitization, and respiratory sensitization. Based on comparison
to analogous esters, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 2 ppb. The 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. To protect against these
risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance in a
consumer product;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin sensitization, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-23-88 (40 CFR 721.12165)
Chemical name: Glycine, reaction products with oxidized
maltodextrin.
CASRN: 2837980-16-0.
Effective date of TSCA Order: July 25, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a flotation aid for the extraction and
removal of ore and a coagulation aid to assist in the removal of waste
products in a wastewater treatment plant. Based on test data for
chelators, EPA has identified concerns for systemic and developmental
toxicity. Based on OncoLogic results, EPA has also identified concerns
for carcinogenicity. The 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.
To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
[[Page 49159]]
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-89 (40 CFR 721.12166)
Chemical name: Maltodextrin, 6-[3-(dimethyl-2-propen-1-
ylammonio)propyl] ether, chloride.
CASRN: 2839190-60-0.
Effective date of TSCA Order: July 25, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a mining and mineral processing agent and
as an industrial wastewater processing agent. Based on the intended use
as a chelator, EPA has identified concerns for developmental and
systemic effects. Based on allyl content, EPA has also identified
concerns for genotoxicity, carcinogenicity, and skin and respiratory
sensitization. Based on comparison to analogous cationic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 14 ppb. The 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. To protect against these risks, the Order
requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 14 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, carcinogenicity, genetic toxicity, pulmonary effects, skin
sensitization, toxicokinetics, reproductive effects, and specific
target organ toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-90 (40 CFR 721.12167)
Chemical name: Dextran, 3-(dimethyl-2-propen-1-ylammonio)propyl
ether, chloride.
CASRN: 2878360-71-3.
Effective date of TSCA Order: July 25, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a mining and mineral processing agent and
as an industrial wastewater processing agent. Based on intended use as
a chelator, EPA has identified concerns for developmental and systemic
effects. Based on allyl content, EPA has also identified concerns for
genotoxicity, carcinogenicity, and skin and respiratory sensitization.
Based on comparison to analogous cationic polymers, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb. The 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. To
protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 2 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, carcinogenicity, genetic toxicity, pulmonary effects, skin
sensitization, toxicokinetics, reproductive effects, and specific
target organ toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-91 (40 CFR 721.12168)
Chemical name: Maltodextrin, oxidized, reaction products with
ethylenediamine.
CASRN: 2824987-68-8.
Effective date of TSCA Order: August 9, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a flotation aid for the extraction and
removal of ore and a coagulation aid to assist in the removal of waste
products in a wastewater treatment plant. Based on test data for
chelators, EPA has identified concerns for systemic and developmental
toxicity. Based on OncoLogic results, EPA has also identified concerns
for carcinogenicity for the inhalation route. Based on comparison to
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 2 ppb. The 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. To protect against these risks, the
Order requires:
No processing for use or use of the PMN substance in a
consumer product;
[[Page 49160]]
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 2 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-92 (40 CFR 721.12169)
Chemical name: Maleic modified rosin polyol ester cyclic acid
(generic).
CASRN: Not available.
Effective date of TSCA Order: September 12, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive in ink formulations. Based on
comparison to analogous chemical substances and information in the SDS,
EPA has identified concerns for eye irritation, skin sensitization, and
respiratory sensitization. Based on comparison to analogous esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 540 ppb. The 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. To protect against these risks, the Order
requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure, or at
least 1,000 when the PMN substance is spray applied;
No processing for use or use of the PMN substance in a
consumer product; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin sensitization, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-23-123 (40 CFR 721.12170)
Chemical name: Phenol, polyalkylcarbomonocycle bis-, polymer with
2- carbomonocyclichaloheteromonocycle,
bis[(alkenylcarbomonocyclic)alkyl] ether (generic).
CASRN: Not available.
Effective date of modified TSCA Order: December 23, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymer of insulating materials. Based
on potential formation of epoxides and the potential for cross-linking,
EPA has identified concerns for skin and respiratory sensitization.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for acute toxicity (inhalation route), skin, eye,
and respiratory tract irritation, pulmonary, neurological,
reproductive, and systemic effects, genetic toxicity, and
carcinogenicity. EPA issued an Order, effective July 26, 2024, 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. To protect against these risks, the Order
requires:
Manufacture and processing of the PMN substance only in
liquid form;
No processing or use of the PMN substance in a consumer
product;
No processing or use of the PMN substance in any manner
that results in inhalation exposure to the PMN substance;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
On December 17, 2024, EPA received a request from the PMN submitter
to modify the language in Written Agreement and Exemptions sections of
the Order. EPA approved the request and issued a modified Order,
effective February 19, 2025, replacing ``unless completely reacted and
cured'' with ``upon being dried to the extent that no release of the
New Chemical Substance can be detected.''
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye irritation, skin irritation, skin sensitization, genetic
toxicity, pulmonary effects, neurotoxicity, reproductive toxicity,
carcinogenicity, and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-135 (40 CFR 721.12171)
Chemical name: Alken-1-ol, 1-acetate (generic).
Accession No.: 302591.
Effective date of TSCA Order: May 21, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for a destructive use. Based on comparison to
analogous chemical substances, EPA has identified concerns for skin,
eye, and respiratory tract irritation and skin sensitization. Based on
comparison to analogous esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 16 ppb. The 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
[[Page 49161]]
to permit a reasoned evaluation, the substance may present an
unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Use of a NIOSH-certified gas/vapor respirator with an APF
of at least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, skin corrosion, skin sensitization, eye irritation, eye
corrosion, pulmonary effects, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-23-152 (40 CFR 721.12172)
Chemical name: 1-Alkanethiol, 3-(trialkoxysilyl)- hydrolysis
products with silica, oxidized (generic).
CASRN: Not available.
Effective date of TSCA Order: July 8, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in a chemical mechanical planarization (CMP)
slurry. Based on comparison to analogous respirable, poorly soluble
particulates, EPA has also identified concerns for lung effects (lung
overload). The 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. To protect
against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-23-160 (40 CFR 721.12173)
Chemical name: Alkenoyl chloride, 3-methyl- (generic).
CASRN: Not available.
Effective date of TSCA Order: May 21, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for a destructive use. Based on comparison to
analogous chemical substances, data for hydrolysis products, and OECD
QSAR Toolbox and Oncologic results, EPA has identified concerns for
corrosion to all tissues, acute toxicity, systemic effects, and skin
and respiratory sensitization. The 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.
To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, pulmonary effects, skin sensitization, and specific target
organ toxicity testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-23-164 (40 CFR 721.12174)
Chemical name: Bismuth, 1,1',1'',1'''-(1,2-
ethanediyldinitrilo)tetrakis[2-propanol] 2-(2-ethoxyethoxy)ethanol
neodecanoate polypropylene glycol complexes.
CASRN: 2374117-53-8.
Effective date of TSCA Order: June 21, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
gelling catalyst for polyurethanes. Based on test data for dissociation
products of the PMN substance, EPA has identified concerns for skin,
eye, and respiratory tract irritation and systemic effects. The 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. To protect against these risks, the
Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of the PMN substance only if the concentration of the
PMN substance does not exceed the confidential percentage by weight in
the final (end use) formulation listed in the Order; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
[[Page 49162]]
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, and specific target organ toxicity testing
may be potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-169 (40 CFR 721.12175)
Chemical name: Alkane, bis(chlorosilane) (generic).
CASRN: Not available.
Effective date of TSCA Order: July 31, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an intermediate. Based on test data for a
hydrolysis product, EPA has identified concerns for corrosion to the
skin, eyes, and respiratory tract. Based on comparison to analogous
chemical substances of the hydrolysis product, EPA has also identified
concerns for acute toxicity, systemic, reproductive, and developmental
effects. The 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. To protect against
these risks, the Order requires:
Use of the PMN substance only as an intermediate;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin corrosion, eye corrosion, specific target organ
toxicity, reproductive toxicity, developmental toxicity, and pulmonary
effects testing may be potentially useful to characterize the health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-23-174 (40 CFR 721.12176)
Chemical name: Mixed metal oxide (generic).
CASRN: Not available.
Effective date of TSCA Order: July 25, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component used in battery manufacturing.
If respirable particles are inhaled, EPA has identified concerns for
respiratory effects, carcinogenicity, and genetic toxicity. Based on
comparison to analogous chemical substances and test data on
components, EPA has also identified concerns for skin sensitization,
respiratory sensitization, and systemic, reproductive, and
developmental effects. Based on comparison to analogous chemical
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 5 ppb. The 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. To protect against these risks, the
Order requires:
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
Processing of the PMN substance only with a composition of
the confidential substance listed in the Order less than the
confidential percentage listed in the Order;
Processing of the PMN substance only as described in the
Order or using process/engineering controls that achieve exposures no
greater than those achieved using the controls described in the Order;
Use of the PMN substance only for the confidential use
listed in the Order;
Disposal of the PMN substance, or any waste stream
containing the PMN substance, if disposed of domestically, must be
disposed in accordance with RCRA Subtitle D Landfill requirements or
RCRA Subtitle C Hazardous Waste Landfill requirements for wastes from
equipment cleaning and deionization of defective cells generated during
processing or use, and by RCRA Subtitle C Hazardous Waste Landfill
requirements for all other wastes;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water;
Personal breathing zone (PBZ) exposure monitoring for
workers likely to have inhalation exposure to the PMN substance, as
described in the Order;
Prior to conducting exposure monitoring, use of a NIOSH-
certified respirator with an APF of at least 1,000 where there is a
potential for inhalation exposure;
After conducting exposure monitoring, use of a NIOSH-
certified respirator with an appropriate APF based on the results of
the exposure monitoring as described in the Order;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
biosolubility, specific target organ toxicity, reproductive toxicity,
developmental toxicity, genetic toxicity, skin sensitization, pulmonary
effects, carcinogenicity, neurotoxicity, and aquatic toxicity testing
may be potentially useful to characterize the health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-23-188 (40 CFR 721.12177)
Chemical name: Alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl
ester (generic); Alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl
ester (generic).
CASRN: Not available.
Effective date of TSCA Order: August 29, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for a destructive use. Based on comparison to
analogous chemical
[[Page 49163]]
substances, EPA has identified concerns for acute toxicity, respiratory
tract irritation, systemic effects, and reproductive and developmental
effects. Based on comparison to analogous vinyl/allyl/propargyl esters,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 0.6 ppb. The 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
substances may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
No processing for use or use of the PMN substances in a
consumer product;
No manufacture, processing, or use of the PMN substances
other than in an enclosed process;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
Disposal of the PMN substances, or waste streams
containing the PMN substances, only by incineration;
No release of the PMN substances, or any waste stream
containing the PMN substances, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, acute toxicity, developmental effects, pulmonary effects,
reproductive toxicity, and specific target organ toxicity testing may
be potentially useful to characterize the health and environmental
effects of the PMN substances. Although the Order does not require
these tests, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
P-23-190 (40 CFR 721.12178)
Chemical name: Fluorophospholane, substituted, alkyl (generic).
CASRN: Not available.
Effective date of TSCA Order: August 1, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an electrolyte additive. Based on
submitted test data on the PMN substance, EPA has identified concerns
for acute toxicity, skin corrosion, systemic, and reproductive and
developmental effects. Based on test data on a hydrolysis product, EPA
has also identified concerns for acute toxicity (inhalation), pulmonary
effects, skin and eye corrosion, respiratory tract irritation, systemic
effects (skeletal fluorosis, dental, blood, liver, kidney), and
reproductive and developmental effects. The 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. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Manufacture, processing, or use of the PMN substance only
in an enclosed process;
Disposal of the PMN substance, or any waste stream
containing the PMN substance, only by incineration;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation/corrosion, pulmonary effects, and specific target organ
toxicity testing may be potentially useful to characterize the health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-24-71 (40 CFR 721.12179), P-24-72 (40 CFR 721.12180), P-24-73 (40 CFR
721.12181), and P-24-74 (40 CFR 721.12182)
Chemical names: Sulfonyl carbamate of ethoxylated fatty alcohol
(generic) (P-24-71), Sulfonyl carbamate of ethoxylated alkyl alcohol
(generic) (P-24-72), and Secondary alcohol ethoxylate of sulfonyl
carbamate (generic) (P-24-73 and P-24-74).
CASRN: Not available.
Effective date of TSCA Order: August 20, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as wetting agents. Based on the physical/
chemical properties of the PMN substances (as described in the New
Chemical Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-
6097-7)) and test data on structurally similar substances, the PMN
substances are potentially PBT chemicals. EPA estimates that the PMN
substances will persist in the environment for more than six months and
estimates a bioaccumulation factor of greater than or equal to 5,000.
Based on structure, EPA has identified concerns for lung effects
(surfactancy). Based on comparison to analogous chemical substances,
EPA has also identified concerns for skin irritation, eye irritation,
respiratory irritation, and developmental, reproductive, and systemic
effects. Based on test data for residuals and analogues of residuals,
EPA has also identified concerns for gastrointestinal effects, systemic
effects, skin irritation, and eye irritation. Based on comparison to
analogous nonionic polymers and carbamate esters, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 0.8 ppb
for the P-24-72 substance. Based on comparison to analogous carbamate
esters, EPA also predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3.4 ppb and 9.5 ppb respectively for the P-
24-73 and P-24-74 substances. The 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
substances may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
No processing for use or use of the PMN substances in a
consumer product;
No manufacture, processing, or use of the PMN substances
in any manner that generates a vapor, mist, dust, or aerosol;
[[Page 49164]]
Use of personal protective equipment where there is a
potential for dermal exposure;
Disposal of the PMN substances, or waste streams
containing the PMN substances, only by hazardous waste incineration in
compliance with the Resource Conservation and Recovery Act;
No release of the PMN substances, or any waste stream
containing the PMN substances, to water; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
bioaccumulation and biodegradation, aquatic toxicity, eye irritation,
pulmonary effects, reproductive/developmental toxicity, skin
irritation, and specific target organ toxicity testing may be
potentially useful to characterize the fate, health, and environmental
effects of the PMN substances. Although the Order does not require
these tests, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
P-24-122 (40 CFR 721.12183)
Chemical name: Sulfonium, polyphenyl(substituted phenyl)
alkylbenzenesulfonate (generic).
CASRN: Not available.
Effective date of TSCA Order: August 27, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an intermediate for
the electronic industry. Based on the physical/chemical properties of
the PMN substance (as described in the New Chemical Program's PBT
category at 64 FR 60194, November 4, 1999 (FRL-6097-7)) and test data
on structurally similar substances, the cation of the PMN substance and
the PMN substance photolysis product are potentially PBT chemicals. EPA
estimates that the PMN substance cation and photolysis product will
persist in the environment for more than six months and estimates a
bioaccumulation factor of greater than or equal to 5,000 for the
photolysis product and that the cation has unknown bioaccumulation
potential. Based on comparison to analogous sulfonium compounds, EPA
has identified concerns for acute toxicity, irritation to the skin and
respiratory tract, eye corrosion, and neurological and systemic effects
for the sulfonium cation of the PMN substance. Based on the
photoreactivity of the PMN substance, EPA has also identified concerns
for photosensitization. Based on comparison to analogous chemical
substances, EPA has also identified concerns for point-of-contact
effects for the anion. Due to insufficient information, EPA was unable
to estimate the environmental hazard of the PMN substance. The 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 or the environment. To protect against
these risks, the Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No processing of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substance only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution or in sealed
containers weighing 5 kilograms or less; and
No exceedance of an annual importation volume of 6 kg for
any use.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
IV. 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
This action proposes to establish SNURs for 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
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 new chemical under TSCA
section 5 are 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
[[Page 49165]]
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 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 7 in Federal fiscal year (FY) 2020, 9 in
FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction
of these submissions were 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
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 28, 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. Add Sec. Sec. 721.12147 through 721.12183 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.12147 Cyclic sulfate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cyclic
sulfate (PMNs P-18-281 and P-21-77) 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
cured or incorporated into an article as defined in Sec. 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), and (c). When determining which persons
are
[[Page 49166]]
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1,000 or at least 50 when using less than the confidential
annual production volume listed in the Order (measured on a year-to-
year basis) of the substance at a use site and when receiving the
substance at 1% or less in formulation.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, skin sensitization,
genetic toxicity, carcinogenicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than for the confidential uses allowed by the Orders
for P-18-281 and P-21-77. It is a significant new use to process the
substance above 5% in formulation.
(iv) Disposal. It is a significant new use to dispose of the
substance or waste streams containing the substance other than using
the confidential method(s) described in the submission for P-21-77, or
by landfill, deep well injection, or using a hazardous waste
incinerator with >=99.999% efficiency). It is a significant new use to
have dust air releases of the substance.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=152.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12148 2,5-Furandione, reaction products with alkylamine, 1-
octanol and polyethylene glycol alkoxy-ether, acetates (salts)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,5-
furandione, reaction products with alkylamine, 1-octanol and
polyethylene glycol alkoxy-ether, acetates (salts) (PMN P-20-73) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, respiratory
sensitization, skin sensitization, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=160.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12149 Metal oxide chloride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
oxide chloride (PMN P-22-2) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted or destroyed.
(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 (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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin corrosion, serious eye
damage, carcinogenicity, specific target organ toxicity, and
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(k) and (t). It is a significant new use to
manufacture or process the substance other than in a sealed, inert
atmosphere environment of a sealed drybox wherever feasible. For
activities performed outside of the drybox that may generate dust or
any exhaust to air, all streams must be treated with caustic water
control technology with a minimum of 90% destruction efficiency.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49167]]
Sec. 721.12150 Ethanol, 2-amino-, compds. with polyethylene glycol
hydrogen sulfate C10-16-alkyl ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanol, 2-amino-,
compds. with polyethylene glycol hydrogen sulfate C10-16-alkyl ether
(PMN P-22-53; CASRN 157627-92-4) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, skin sensitization,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=14.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12151 Edge oxidized carbon matrix (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as edge
oxidized carbon matrix (PMN P-22-114) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance when entrained in a cured coating or when
incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 10,000.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.00733 mg/m\3\
as an 8-hour time weighted average. Persons who wish to pursue NCELs as
an alternative to Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12152 Propaneamine, 3-(alkyloxy)-, structural variants
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propaneamine, 3-(alkyloxy)-, structural variants (PMN P-22-123) 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)(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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=6.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
[[Page 49168]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12153 Propanenitrile, 3-(alkyloxy)-, structural variance
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanenitrile, 3-(alkyloxy)-, structural variance (PMN P-22-124) 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)(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), (g)(3)(iii), and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, skin sensitization, genetic toxicity,
reproductive toxicity, specific target organ toxicity, and
carcinogenicity. 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). It is a significant new use to
manufacture the substance with the residual confidential feedstock
listed in the Order present at great than 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=45.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12154 Cellulose, polymer with 1,1'-[2-ethyl-2-[(3-mercapto-
1-oxopropoxy)methyl]-1,3-propanediyl] bis(3- mercaptopropanoate) and
1,2,3-propanetriol bis(2-methyl-2-propenoate), peroxydisulfuric acid
([(HO)S(O)2]2O2) ammonium salt (1:2)- and sodium (disulfite) (2:1)-
initiated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cellulose, polymer
with 1,1'-[2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]-1,3-propanediyl]
bis(3- mercaptopropanoate) and 1,2,3-propanetriol bis(2-methyl-2-
propenoate), peroxydisulfuric acid ([(HO)S(O)2]2O2) ammonium salt
(1:2)- and sodium (disulfite) (2:1)-initiated (PMN P-22-126; CASRN
2696236-02-7) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to the substance. It is
a significant new use to process for use or use the substance in
consumer products where the concentration of the substance exceeds the
confidential concentration by weight listed in the Order.
(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 (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12155 Alkyl dialkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
dialkylamine (PMN P-22-137) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(t). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance. It is a significant new use to
manufacture, process, or use the substance at any facility not equipped
with pollution controls with a destruction efficiency of 99.98% or
greater. It is a significant new use to use the substance other than as
a chemical intermediate for a quaternary ammonium salt.
(iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(a)(3), (b)(1), (b)(3), (c)(1), and (c)(3).
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49169]]
Sec. 721.12156 Tetraalkylammonium chloride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tetraalkylammonium chloride (PMN P-22-138) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to the substance. It is
a significant new use to manufacture, process, or use the substance at
any facility not equipped with pollution controls with a destruction
efficiency of 99.98% or greater. It is a significant new use to use the
substance other than as an intermediate for making hydroxide salt.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(3), (b)(1), (b)(3), (c)(1), and (c)(3).
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12157 1,3,5-Cycloheptatriene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3,5-
cycloheptatriene (PMN P-22-185; CASRN 544-25-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or cured.
(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 (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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, eye irritation, skin irritation, skin sensitization, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture, process, or use the substance in any manner unless using
engineering control measures that ensure that loading and unloading of
transport containers does not result in inhalation exposures to the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12158 [Reserved]
Sec. 721.12159 Amines, polyalkylenepoly, (disubstitutedcarboxy)
derivs., alkali metal salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amines,
polyalkylenepoly, (disubstitutedcarboxy) derivs., alkali metal salts
(PMN P-23-15) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, skin sensitization,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=23.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49170]]
Sec. 721.12160 Phenol, polyalkylcarbo bis-, polymer with 2-
carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl]
ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
polyalkylcarbo bis-, polymer with 2-carbomonocyclichaloheteromonocycle,
bis[(alkenylcarbomonocyclic)alkyl] ether (PMN P-23-30) 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 dried to
the extent that no release of the substance can be detected.
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, respiratory sensitization, skin
sensitization, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (w)(1), (w)(2), (w)(4), (x)(1),
(x)(2), and (x)(4). It is a significant new use to process or use the
substance in any manner that results in inhalation exposure to the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12161 Siloxanes and silicones, di-alkyl, hydroxy-terminated,
polymers with substituted alkane and substituted silane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-alkyl, hydroxy-terminated, polymers with
substituted alkane and substituted silane (PMN P-23-46) 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 cured.
(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 (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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (v)(1), (v)(2), (v)(4), (w)(1),
(w)(2), (w)(4), (x)(1), (x)(2), and (x)(4).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12162 Alkyl acid, 2[hyphen]hydroxy-, methyl substituted
alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
acid, 2-hydroxy[hyphen], methyl substituted alkyl ester (PMN P-23-65)
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)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, serious eye damage, reproductive toxicity, specific target
organ toxicity, and carcinogenicity. 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=220.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49171]]
Sec. 721.12163 Oils, Pisum sativum, polymers with 1,6-
diisocyanatohexane, 1,5-diisocyanatopentane, glycerol and maltodextrin.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, pisum
sativum, polymers with 1,6-diisocyanatohexane, 1,5-diisocyanatopentane,
glycerol and maltodextrin (PMN P-23-69; CASRN 3063505-38-1) 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 (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity
(lung effect if the product becomes airborne). 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(y)(1) and (2). It is a significant new use
to manufacture or process the substance in a manner that generates a
vapor, mist, aerosol, or dust. It is a significant new use to process
the substance for use in a consumer product that can be spray applied.
(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 (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12164 Rosin, maleated, polymer with benzoic acid, glycerol,
propylene glycol and 3a,4,7,7a-tetrahydro-1,3- isobenzofurandione.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rosin, maleated,
polymer with benzoic acid, glycerol, propylene glycol and 3a,4,7,7a-
tetrahydro-1,3- isobenzofurandione (PMN P-23-79; CASRN 2766660-60-8) 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 substance after they have
been completely reacted or cured.
(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 (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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: eye
irritation, skin sensitization, and respiratory sensitization.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12165 Glycine, reaction products with oxidized maltodextrin.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycine, reaction
products with oxidized maltodextrin (PMN P-23-88; CASRN 2837980-16-0)
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 cured.
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: carcinogenicity and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12166 Maltodextrin, 6-[3-(dimethyl-2-propen-1-
ylammonio)propyl] ether, chloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin, 6-[3-
(dimethyl-2-propen-1-ylammonio)propyl] ether, chloride (PMN P-23-89;
CASRN 2839190-60-0) 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 cured.
(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
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
[[Page 49172]]
considered and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: respiratory
sensitization, skin sensitization, genetic toxicity, carcinogenicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=14.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12167 Dextran, 3-(dimethyl-2-propen-1-ylammonio)propyl
ether, chloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as dextran, 3-
(dimethyl-2-propen-1-ylammonio)propyl ether, chloride (PMN P-23-90;
CASRN 2878360-71-3) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: respiratory
sensitization, skin sensitization, genetic toxicity, carcinogenicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12168 Maltodextrin, oxidized, reaction products with
ethylenediamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
oxidized, reaction products with ethylenediamine (PMN P-23-91; CASRN
2824987-68-8) 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
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause:
carcinogenicity and 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 a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(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 (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12169 Maleic modified rosin polyol ester cyclic acid
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as maleic
modified rosin polyol ester cyclic acid (PMN P-23-92) 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 cured.
(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 (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, or 1,000 when the
substance is spray applied.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: eye
irritation, skin sensitization, and respiratory sensitization.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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
[[Page 49173]]
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12170 Phenol, polyalkylcarbomonocycle bis-, polymer with 2-
carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl]
ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
polyalkylcarbomonocycle bis-, polymer with 2-
carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl]
ether (PMN P-23-123) 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 upon being dried to the extent that no release of the
substance can be detected.
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, skin sensitization, genetic toxicity,
reproductive toxicity, carcinogenicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (w)(1), (w)(2), (w)(4), (x)(1),
(x)(2), and (x)(4). It is a significant new use to process or use the
substance in any manner that results in inhalation exposure to the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12171 Alken-1-ol, 1-acetate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alken-
1-ol, 1-acetate (PMN P-23-135; Accession No. 302591) 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)(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 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12172 1-Alkanethiol, 3-(trialkoxysilyl)- hydrolysis products
with silica, oxidized (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as 1-alkanethiol,
3-(trialkoxysilyl)- hydrolysis products with silica, oxidized (PMN P-
23-152) 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 (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(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 (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12173 Alkenoyl chloride, 3-methyl- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoyl chloride, 3-methyl- (PMN P-23-160) 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)(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
[[Page 49174]]
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), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
skin sensitization, respiratory sensitization, serious eye damage, and
specific target organ toxicity. 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(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12174 Bismuth, 1,1',1'',1'''-(1,2-
ethanediyldinitrilo)tetrakis[2-propanol] 2-(2-ethoxyethoxy)ethanol
neodecanoate polypropylene glycol complexes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as bismuth,
1,1',1'',1'''-(1,2-ethanediyldinitrilo)tetrakis[2-propanol] 2-(2-
ethoxyethoxy)ethanol neodecanoate polypropylene glycol complexes (PMN
P-23-164; CASRN 2374117-53-8) 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 substance after they have been completely reacted or
cured.
(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 (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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance unless the concentration of the substance does not exceed the
confidential percentage by weight in the final (end use) formulation
listed in the Order.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12175 Alkane, bis(chlorosilane) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
bis(chlorosilane) (PMN P-23-169) 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)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
serious eye damage, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12176 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
metal oxide (PMN P-23-174) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been incorporated into an article as
defined at 40 CFR 720.3(c) or when the substance is embedded in or
cured in a matrix.
(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 (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 before conducting
the exposure monitoring described in the Order and then an APF based on
the results of exposure monitoring described in the Order. It is a
significant new use to manufacture the chemical substance without the
monitoring program required in the Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and
[[Page 49175]]
(g)(5). For purposes of Sec. 721.72(g)(1), this substance may cause:
carcinogenicity, genetic toxicity, skin sensitization, respiratory
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
process the substance other than with the confidential substance
described in the Order at a composition less than the confidential
percentage listed in the Order. It is a significant new use to process
the substance other than as described in the Order unless using
process/engineering controls that achieve exposures no greater than
those achieved using the controls described in the Order.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, domestically
other than by RCRA Subtitle D Landfill requirements or RCRA Subtitle C
Hazardous Waste Landfill requirements, for wastes from equipment
cleaning and deionization of defective cells generated during
processing and use, or by RCRA Subtitle C Hazardous Waste Landfill
requirements for all other wastes.
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12177 Alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl
ester; alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl ester; alkenoic
acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl ester (PMN P-23-188) 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)(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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), these substances may cause: acute
toxicity, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c), and (o).
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) 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 (k) are applicable to manufacturers, importers, and
processors of these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12178 Fluorophospholane, substituted, alkyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorophospholane, substituted, alkyl (PMN P-23-190) 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 entrained
in an article as defined at 40 CFR 720.3(c).
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
serious eye damage, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c), and (o).
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12179 Sulfonyl carbamate of ethoxylated fatty alcohol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonyl carbamate of ethoxylated fatty alcohol (PMN P-24-71) 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 cured.
(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
reasonably likely to be exposed as
[[Page 49176]]
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of the
substance other than by hazardous waste incineration in compliance with
the Resource Conservation and Recovery Act.
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12180 Sulfonyl carbamate of ethoxylated alkyl alcohol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonyl carbamate of ethoxylated alkyl alcohol (PMN P-24-72) 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 cured.
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of the
substance other than by hazardous waste incineration in compliance with
the Resource Conservation and Recovery Act.
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12181 Secondary alcohol ethoxylate of sulfonyl carbamate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
secondary alcohol ethoxylate of sulfonyl carbamate (PMN P-24-73 is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after it has been
completely reacted or cured.
(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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, reproductive toxicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of this
substance other than by hazardous waste incineration in compliance with
the Resource Conservation and Recovery Act.
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12182 Secondary alcohol ethoxylate of sulfonyl carbamate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
secondary alcohol ethoxylate of sulfonyl carbamate (PMN P-24-74) 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 it has been
completely reacted or cured.
(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
reasonably likely to be exposed as
[[Page 49177]]
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, reproductive toxicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of this
substance other than by hazardous waste incineration in compliance with
the Resource Conservation and Recovery Act.
(v) 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 (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12183 Sulfonium, polyphenyl(substituted phenyl)
alkylbenzenesulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, polyphenyl(substituted phenyl) alkylbenzenesulfonate (PMN P-
24-122) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered onto a
semiconductor wafer surface or similar manufactured article used in the
production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), (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: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
exceed an annual importation volume of 6 kilograms for any use. It is a
significant new use to import the substance other than in solution,
unless in sealed containers weighing 5 kilograms or less. It is a
significant new use to process the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2025-19756 Filed 10-31-25; 8:45 am]
BILLING CODE 6560-50-P