[Federal Register Volume 90, Number 210 (Monday, November 3, 2025)]
[Proposed Rules]
[Pages 49180-49207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19757]
[[Page 49179]]
Vol. 90
Monday,
No. 210
November 3, 2025
Part IV
Environmental Protection Agency
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40 CFR Part 721
Significant New Use Rules on Certain Chemical Substances (25-2.5e);
Proposed Rule
Federal Register / Vol. 90, No. 210 / Monday, November 3, 2025 /
Proposed Rules
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2025-0314; FRL-12931-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (25-
2.5e)
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-2025-0314, 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: Punam Tyagi, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1176; 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 $45,496 per SNUN
submission for large business submitters and $14,976 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
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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/dockets/commenting-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 the 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 has determined it
is appropriate:
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
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under the procedure in 40 CFR 721.11 into a single step.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
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.
[[Page 49183]]
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
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 (e.g., 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).
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-18-104 (40 CFR 721.12184)
Chemical Name: Heteroaromatic substituted alkanoic acid, [2,2-
bis[[(1-oxo-2-propen-1-yl)oxy]methyl]- 1,3-propanediyl] ester, dioxide
homopolymer (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: October 3, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
halogen-free flame retardant for use in thermoplastic polymers. Based
on the PMN substance meeting the criteria of being insoluble in water
and being non-reactive, respirable, and a high molecular weight
polymer, EPA has 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:
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture) and only if the
concentration of the PMN substance in formulation does not exceed the
confidential percentage by weight listed in the Order;
Use of the PMN substance only as a halogen-free flame
retardant for use in thermoplastic polymers;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 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
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-18-413 (40 CFR 721.12185)
Chemical Name: Ethanol, 2,2-difluoro-, 1-acetate.
CASRN: 1550-44-3.
Effective Date of TSCA Order: October 10, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a specialty additive. Based on submitted
test data on the PMN substance, EPA has identified concerns for
systemic effects, immunotoxicity, portal-of-entry effects, and
reproduction and developmental toxicity. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
skin and eye corrosion, portal-of-entry effects, systemic effects, and
neurotoxicity for the incineration and hydrolysis products. Based on
potential oral toxicity for systemic effects, EPA identified a drinking
water equivalent level (DWEL) of 554 ppb. Based on submitted test data
on the PMN substance and comparison to analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
670 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
other than in an enclosed process;
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 554 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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
occupational/workplace exposure monitoring may be potentially useful to
characterize the exposure 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-21-88 (40 CFR 721.12186)
Chemical Name: Heterocyclic epoxide polymer with mixed substituted
glycols and acid anhydride (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 28, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a molding compound. Based on comparison to
analogous chemical substances and test data for feedstock residuals,
EPA has identified concerns
[[Page 49184]]
for acute toxicity, acute neurotoxicity, skin, eye, and respiratory
tract irritation, eye corrosion, skin sensitization, mortality,
systemic effects, respiratory tract effects, local irritation effects
(stomach), reproductive/developmental effects, and genotoxicity for the
low molecular weight fractions of the PMN substance and the feedstock
residuals. Based on the weight of evidence, EPA has also identified
concerns for respiratory sensitization. Based on OncoLogic results, EPA
has also identified concerns for carcinogenicity for the low molecular
weight fractions and a feedstock residual. Based on comparison to
analogous polyepoxides and esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 7 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 1,000 where there is a potential for inhalation exposure;
No manufacture of the PMN substance as a solid without the
use of a fume hood, dust collector, or other engineering controls with
at least 25% combined capture and removal efficiency of aggregate
releases of the total process, unless in an enclosed process;
No processing or use of the PMN substance as a solid
without the use of a fume hood, dust collector, or other engineering
controls with at least 25% combined capture and removal efficiency,
unless in an enclosed process;
No release of the PMN substance, or any waste stream
containing the PMN substance, to water;
No disposal of the PMN substance, or waste streams
containing the PMN substance, other than by incineration or hazardous
waste landfill in compliance with RCRA subtitle C; and
Establishment of a hazard communication program, including
human health and environmental 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
developmental toxicity, reproductive toxicity, 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-21-215 (40 CFR 721.12187)
Chemical Name: Pyridinium, 3-carboxy-1-methyl-, inner salt.
CASRN: 535-83-1.
Effective Date of TSCA Order: January 22, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
primarily aqueous alkaline electroplating solution that produces a
nominal zinc (Zn)-nickel (Ni) alloy deposit on iron bearing substrates
(this deposit improves the corrosion resistance of the iron bearing
substrates that it is applied to; the PMN substance is a secondary
brightening additive that is used in instances where the inherent
specularity of the plating deposit is unsatisfactory). Based on
comparison to analogous chemical substances, EPA has identified
concerns for eye and respiratory tract irritation, clinical signs
(niacin flush), systemic effects, and reproductive/developmental
effects. Based on comparison to analogous chemical substances, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 770 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 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;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 770 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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, reproductive effects, developmental
toxicity, serious eye damage, 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-22-60 (40 CFR 721.12188) and P-22-61 (40 CFR 721.12189)
Chemical Names: Polyol allyl ether, homopolymer terpene ether and
polyol allyl ether, homopolymer, alkyl ethers (generic) (P-22-60 and P-
22-61).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 19, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as intermediates. Based on comparison to
analogous chemical substances, EPA has identified concerns for
carcinogenicity, genetic toxicity, portal-of-entry (oral) effects,
acute toxicity, corrosion to all tissues, skin sensitization, and
systemic effects. Based on the pH of the chemical substances, EPA has
also identified concerns for irritation to skin, eyes, and respiratory
tract. Based on potential activation of the terminal allyl moieties to
yield DNA-reactive metabolites, EPA has also identified concerns for
genetic toxicity and carcinogenicity. Based on the potential for
epoxidation of terminal double bonds and subsequent formation of
functional reactive groups capable of binding carrier proteins, EPA has
also identified concerns for skin and respiratory sensitization. Based
on information in the SDS, EPA has also identified concerns for acute
toxicity and skin sensitization. Based on comparison to analogous
chemical substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 18 ppb (P-22-60) and 2 ppb (P-22-
61). The Order was issued under TSCA sections
[[Page 49185]]
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 manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
No processing for use or use of the PMN substances in a
consumer product formulation;
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;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health and environmental 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
toxicokinetics, acute toxicity, skin irritation/corrosion, eye
irritation/corrosion, skin sensitization, specific target organ
toxicity, pulmonary effects, genetic toxicity, carcinogenicity, and
aquatic 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-22-64 (40 CFR 721.12190) and P-22-65 (40 CFR 721.12191)
Chemical Names: Polyol allyl ether, polymer with alkylene oxides,
terpene ether and polyol allyl ether, polymer with alkylene oxides,
alkyl ethers (generic) (P-22-64 and P-22-65).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 19, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as intermediates. Based on comparison to
analogous chemical substances, EPA has identified concerns for
carcinogenicity, genetic toxicity, portal-of-entry (oral) effects,
acute toxicity, corrosion to all tissues, skin sensitization, and
systemic effects. Based on the pH of the chemical substances, EPA has
also identified concerns for irritation to skin, eyes, and respiratory
tract. Based on potential activation of the terminal allyl moieties to
yield DNA-reactive metabolites, EPA has also identified concerns for
genetic toxicity and carcinogenicity. Based on the potential for
epoxidation of terminal double bonds and subsequent formation of
functional reactive groups capable of binding carrier proteins, EPA has
also identified concerns for skin and respiratory sensitization. Based
on comparison to analogous nonionic surfactants, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 101 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 manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
No processing for use or use of the PMN substances in a
consumer product formulation;
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;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health and environmental 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
toxicokinetics, acute toxicity, skin irritation/corrosion, eye
irritation/corrosion, skin sensitization, specific target organ
toxicity, pulmonary effects, genetic toxicity, carcinogenicity, and
aquatic 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-22-66 (40 CFR 721.12192) and P-22-67 (40 CFR 721.12193)
Chemical Names: Polyol allyl ether, polymer with alkylene oxides,
terpene ether sulfate, ammonium salt and polyol allyl ether, polymer
with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-
22-66 and P-22-67).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 19, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as additives for adhesives and coatings.
Based on comparison to analogous chemical substances, EPA has
identified concerns for acute toxicity, corrosion to all tissues, skin
sensitization, portal-of-entry (oral) effects, systemic effects, and
genetic toxicity. Based on structure, comparison to analogous chemical
substances, and the intended use as a surfactant, EPA has also
identified concerns for carcinogenicity, respiratory sensitization, and
lung effects. Based on comparison to analogous chemical substances, EPA
predicts that one substance (P-22-66) is expected to have low
environmental hazard and that toxicity to aquatic organisms may occur
at concentrations that exceed 98 ppb for the other substance (P-22-67).
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 manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
No processing for use or use of the PMN substances in a
consumer product formulation;
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;
[[Page 49186]]
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health and environmental 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
toxicokinetics, skin corrosion, eye corrosion, skin sensitization,
specific target organ toxicity, pulmonary effects, genetic toxicity,
carcinogenicity, acute toxicity, and aquatic 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-22-153 (40 CFR 721.12194)
Chemical Name: 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester,
reaction products with 2-oxepanone homopolymer 2-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]ethyl] ester and phosphorous oxide (P2O5).
CASRN: 2548699-72-3.
Effective Date of TSCA Order: March 7, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
adhesion promoter in a resin used for adhesives and/or sealants in
industrial assembly or manufacturing operations and in outdoor repair
operations for windmill blades. Based on comparison to analogous
acrylates/methacrylates, EPA has identified concerns for irritation to
the skin, eyes, and respiratory tract and skin and respiratory tract
sensitization. Based on comparison to analogous chemical substances,
EPA has also identified concerns for skin irritation, systemic effects,
neurotoxicity, and carcinogenicity. Based on the presence of
methacrylates, skin and/or respiratory sensitization alerts in the OECD
QSAR Toolbox, and the weight of the scientific evidence, EPA has also
identified concerns for skin and respiratory sensitization for the low
molecular weight fractions. Based on data for a residual/hydrolysis
product, EPA has also identified concerns for neurotoxicity, skin
irritation, eye irritation/corrosion, skin sensitization, and systemic
effects. Based on a structural alert for phosphate esters, EPA has also
identified concerns for delayed neurotoxicity and genetic toxicity.
Based on comparison to analogous esters, methacrylates, and inorganic
phosphate, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3 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 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 3 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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, genetic toxicity, skin sensitization, skin irritation,
respiratory irritation, eye irritation/corrosion, 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-22-165 (40 CFR 721.12195)
Chemical Name: Alkyl acid, 2-hydroxy-, methyl substituted alkyl
ester (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: January 13, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an industrial process chemical. Based on
comparison to analogous chemical substances and data for hydrolysis
products and a metabolite of the chemical substance, EPA has identified
concerns for lung toxicity (surfactancy), eye corrosion, respiratory
tract irritation, clinical signs, neurotoxicity, systemic effects,
reproductive and developmental effects, and carcinogenicity. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 231 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 1,000 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance other
than for the confidential use listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 231 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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, 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
[[Page 49187]]
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-9 (40 CFR 721.12196) and P-23-10 (40 CFR 721.12197)
Chemical Names: Cysteine, cyclic alkyl, ethyl ester; alkylthio
ketone (P-23-9 and P-23-10) (generic).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: October 4, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as fragrance ingredients for use in laundry
applications. Based on submitted test data on the PMN substances, EPA
has identified concerns for skin sensitization. Based on test data for
a stereoisomer, EPA has also identified concerns for skin irritation
for the degradation product for the P-23-9 substance. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for systemic effects. Based on test data on the degradation
products, EPA has also identified concerns for acute toxicity, skin,
eye, and respiratory tract irritation, systemic effects (body weight,
liver, kidney, and lungs) and reproductive effects for the P-23-10
substance. Based on submitted test data on the PMN substances and
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 substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
No manufacture or processing of the PMN substances in any
manner that results in inhalation exposure to the PMN substances;
No processing for use or use of the PMN substances in a
consumer product unless the concentration of the PMN substances does
not exceed 0.1% (P-23-9) or 1% (P-23-10) by weight in the consumer
product;
No land application of the PMN substances, or waste
streams containing the PMN substances, to agricultural lands;
Use of personal protective equipment where there is a
potential for dermal exposure;
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 and environmental 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 chronic
aquatic 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-23-32 (40 CFR 721.12198)
Chemical Name: 1,3-Propanediol, polymer with 1,3-
diisocyanatomethylbenzene.
CASRN: 67517-96-8.
Effective Date of TSCA Order: June 13, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
prepolymer in industrial belting, no-crush wheels, and a general
replacement for polytetramethylene ether glycol (PTMEG)-based cast
urethane parts. Based on comparison to analogous diisocyanates, EPA has
identified concerns for skin sensitization and lung toxicity. Based on
test data for a residual, EPA has also identified concerns for acute
toxicity, skin and respiratory sensitization, lung toxicity, systemic
effects, reproductive/developmental effects, genotoxicity, and
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;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
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 acute
toxicity, skin sensitization, pulmonary effects, specific target organ
toxicity, reproductive toxicity, developmental toxicity, genetic
toxicity, and carcinogenicity 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-23-118 (40 CFR 721.12199)
Chemical Name: Glycerides from fermentation of genetically modified
microorganism, ethoxylated, reaction products with ethanol, polycyclic
isocyanate (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: March 4, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a reactant. Based on comparison to
analogous diisocyanates, EPA has identified concerns for skin and
respiratory sensitization, skin, eye, and respiratory tract irritation,
and pulmonary 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 personal protective equipment where there is a
potential for dermal exposure;
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, use, or disposal of the PMN
substance in any manner that results in inhalation exposure to the PMN
substance;
Manufacture of the PMN substance in a formulation only
where the percentage of the unreacted confidential substance listed in
the Order does not
[[Page 49188]]
exceed the confidential percentage by weight listed in the Order;
No disposal of the PMN substance, or waste streams
containing the PMN substance, other than by hazardous waste
incineration and the disposal must be at a facility that is in
compliance with RCRA subtitle C; 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, pulmonary effects, skin irritation, and skin sensitization
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-23-142 (40 CFR 721.12200)
Chemical Name: Alkenal, 9-(acetyloxy)-, (E)- (generic).
Accession No.: 302751.
Effective Date of TSCA Order: June 11, 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 and
respiratory tract irritation, and systemic, reproductive, and
developmental effects for the PMN substance and the alcohol ester
hydrolysis product. Based on comparison to analogous chemical
substances and potential oxidation that is expected to produce
bifunctional reactive groups, EPA has also identified concerns for
respiratory sensitization for the alcohol ester hydrolysis product.
Based on comparison to analogous aldehydes and esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 7
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:
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 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 substance, or waste streams containing
the PMN substance, only by incineration;
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 sensitization, pulmonary effects, specific target
organ 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-23-173 (40 CFR 721.12201)
Chemical Name: Cellulose, alkoxyalkyl ether, alkali metal salt
(generic).
Accession No.: 303061.
Effective Date of TSCA Order: January 10, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component used in battery manufacturing.
Based on test data for the cation, EPA has identified concerns for
systemic effects, neurotoxicity, reproductive effects, and
developmental effects. Based on comparison to analogous chemical
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 120 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 10 where there is a potential for inhalation exposure;
No use of the PMN substance other than for the
confidential use listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 120 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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, reproductive 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-24-4 (40 CFR 721.12202)
Chemical Name: Benzoylated amino acid salt (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 28, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a plastic production aid. Based on
comparison to analogous chemical substances, EPA has identified
concerns for systemic effects. Based on comparison to analogous
chemical substances and information provided in the SDS, EPA has also
identified concerns for eye irritation. 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
[[Page 49189]]
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 10 where there is a potential for inhalation exposure;
Manufacture of the PMN substance only below the
confidential annual production volume listed in the Order;
No processing for use or use of the PMN substance other
than 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
pulmonary effects, reproductive toxicity, developmental toxicity, 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-24-79 (40 CFR 721.12203)
Chemical Name: Alkylated succinimide (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: February 26, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a fuel additive. 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 1999) 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 comparison to
analogous chemical substances, EPA has identified concerns for systemic
effects. Based on comparison to analogous imides, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 0.036 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 the PMN substance only for the confidential use
listed in the Order;
Manufacture, processing, and disposal of the PMN substance
only in a manner that does not result in inhalation exposure to the PMN
substance;
No release of the PMN substance, or waste streams
containing the PMN substance, to water;
No disposal of the PMN substance, or waste streams
containing the PMN substance, other than by hazardous waste
incineration in compliance with RCRA, including RCRA subtitle C; and
Establishment of a hazard communication program, including
human health and environmental 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, persistence, specific target organ toxicity, sediment
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health, environmental, and fate 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-24-82 (40 CFR 721.12204)
Chemical Name: 2-Propenoic acid, 3-bromo-2,2-bis(bromomethyl)propyl
ester.
CASRN: 3217-37-6.
Effective Date of TSCA Order: May 13, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive used in 3D printing ink
formulations. Based on comparison to analogous acrylates and OECD QSAR
toolbox results, EPA has identified concerns for irritation and
sensitization. Based on the OECD QSAR Toolbox alert for Michael
Addition and comparison to analogous acrylates, EPA has also identified
concerns for respiratory sensitization. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
skin irritation, eye irritation, and genetic toxicity. Based on
comparison to analogous chemical substances of the pentaerythritol
tribromide hydrolysis product, EPA has also identified concerns for
acute toxicity, eye irritation, genetic toxicity, systemic effects,
reproductive/developmental effects, and carcinogenicity. Based on test
data for the acrylic acid hydrolysis product, EPA has also identified
concerns for skin corrosion, serious eye damage, respiratory tract
corrosion, systemic effects, and developmental effects. Based on
comparison to analogous acrylates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 4 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;
Manufacture of the PMN substance only by import into the
United States in ink cartridges (i.e., no domestic manufacture);
No processing, use, or disposal of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No processing for use or use of the PMN substance in a
consumer product;
The PMN substance, or cartridges or waste streams
containing the PMN substance, must be disposed of by hazardous waste
incineration in compliance with RCRA;
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 and environmental 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
[[Page 49190]]
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,
acute toxicity, carcinogenicity, serious eye damage, reproductive
toxicity, skin corrosion, skin sensitization, 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-24-85 (40 CFR 721.12205)
Chemical Name: Siloxanes and Silicones, di-Me, 3-[[[[4-[(4-
isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl
group-terminated.
CASRN: 1411848-76-4.
Effective Date of TSCA Order: March 3, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
curative for polyurethane sealant. Based on comparison to analogous
diisocyanates, EPA has identified concerns for acute toxicity
(inhalation), irritation to the skin, eyes, and respiratory tract, skin
and respiratory sensitization, and pulmonary toxicity. 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:
Manufacture, processing, or use of the PMN substance only
in a manner that does not result in inhalation exposure to the PMN
substance;
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; 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, skin irritation, and skin
sensitization 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-24-102 (40 CFR 721.12206) and P-24-103 (40 CFR 721.12207)
Chemical Names: Polyester polymer with polyether polymer and 1,1'-
methylenebis(4-isocyanatobenzene) (generic) (P-24-102) and polyester
polymer with polyether polymer and 1,1'-methylenebis(isocyanatobenzene)
(generic) (P-24-103).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: January 28, 2025.
Basis for TSCA Order: The PMNs state that the uses will be as
industrial adhesives. Based on the structure of the PMN substances and
comparison to analogous diisocyanates, EPA has identified concerns for
skin and respiratory sensitization and irritation to the skin, eyes,
and respiratory tract. 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 substances in a
consumer product;
No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
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 eye
irritation, pulmonary effects, skin irritation, and skin sensitization
testing may be potentially useful to characterize the health 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-24-129 (40 CFR 721.12208)
Chemical Name: Alkanoic acid, mercapto-, ((((mercapto-oxoalkoxy)-
(mercapto-oxoalkoxy)alkyl)alkoxy)alkyl)-((mercapto-oxoalkoxy)alkyl)-
alkanediyl ester (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 7, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a monomer. Based on comparison to
analogous chemical substances, EPA has identified concerns for acute
toxicity, skin sensitization, and systemic and developmental effects.
Based on OECD QSAR Toolbox results, EPA has also identified concerns
for respiratory sensitization. Based on comparison to analogous thiols
and mercaptans, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1.6 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 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 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, resulting in surface water concentrations
that exceed 1.6 ppb; and
Establishment of a hazard communication program, including
human health and environmental 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
[[Page 49191]]
be designated by this SNUR. EPA has determined that the results of skin
sensitization, acute toxicity, pulmonary effects, developmental
toxicity, specific target organ toxicity, toxicokinetics, 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-24-185 (40 CFR 721.12209) and P-25-28 (40 CFR 721.12210)
Chemical Names: Sulfonium, triphenyl-, salt with fluorosulfoalkyl-
fluoroalkyl substituted-heterotricycloalkane-carboxylate (1:1)
(generic) (P-24-185) and heteroonium,
tri(substitutedaromatichydrocarbon)-, nitrate (1:1) (generic) (P-25-
28).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: March 5, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the PMN substances will be for contained use for
microlithography for electronic device manufacturing. 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 1999) and
in the absence of data, the PMN substances and photolysis products are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the PMN substances will persist in the environment for
more than two months and that their potential to bioaccumulate is
unknown. EPA estimates that the photolysis products will persist in the
environment for more than two months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on comparison to
analogous compounds, EPA has identified concerns for acute toxicity,
irritation to the skin and respiratory tract, eye corrosion,
neurological effects, and systemic effects for the cations of the PMN
substances. Based on the photoreactivity of the PMN substances, EPA has
also identified concerns for photosensitization. Based on comparison to
analogous chemical substances, EPA also identified concerns for genetic
toxicity. Based on the OECD QSAR Toolbox alert, EPA has also identified
concerns for skin sensitization for the anion of P-24-185. Based on
test data of an analogue, EPA has also identified concerns for
carcinogenicity, genetic toxicity, blood toxicity (methemoglobinemia),
and systemic, reproductive, and developmental effects for the anion of
P-25-28. Based on insufficient information, the PMN substances have
unknown toxicity to aquatic organisms. 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 or the environment. To protect against these risks, the
Order requires:
No manufacture of the PMN substances 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 and environmental precautionary statements on each label
and in the SDS;
No processing of the PMN substances in any way that
generates a dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed the Order.
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 substances 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.
P-24-187 (40 CFR 721.12211)
Chemical Name: Alkyl transition metal alkoxide (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: January 14, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical intermediate. Based on
reactivity and comparison to analogous chemical substances, EPA has
identified concerns for skin, eye, and respiratory tract corrosion.
Based on test data for hydrolysis products, EPA has also identified
concerns for systemic effects, neurological effects, developmental
effects, and lung toxicity. Based on comparison to analogous chemical
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 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 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 use of the PMN substance other than for the
confidential use listed in the Order;
No manufacture, processing, or use of the PMN substance in
any manner that generates a vapor, mist, dust, or aerosol outside of a
fully enclosed system containing the PMN substance;
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 and environmental 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, skin irritation/corrosion, eye
irritation/corrosion, neurotoxicity, developmental 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
[[Page 49192]]
based on submission of this or other relevant information.
P-24-189 (40 CFR 721.12212)
Chemical Name: Silsesquioxanes, alkyl Ph
alkoxy(halosubstitutedphenyl), polymers with silicic acid (H4SiO4)
tetra-Me ester, hydroxy-terminated (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: December 16, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for contained use for microlithography for
electronic device manufacturing. Based on comparison to analogous
chemical substances, EPA has identified concerns for acute inhalation
toxicity and lung 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 manufacture, 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; 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 and pulmonary 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-25-3 (40 CFR 721.12213) and P-25-4 (40 CFR 721.12214)
Chemical Names: Phenoxathiinium, 10-phenyl-,
tricycloalkylcarbomonocyclesulfonate (1:1) (generic) (P-25-3) and
sulfonium, triphenyl-, heteropolyclyclecarboxylate (1:1) (generic) (P-
25-4).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: February 11, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the PMN substances will be for contained use for
microlithography for electronic device manufacturing. 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 1999) and
in the absence of data, the anion, cation, and cation photodegradation
product of the P-25-3 substance and the anion and cation
photodegradation product of the P-25-4 substance are potentially
persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates
that the anion and cation of P-25-3 will persist in the environment for
more than six months and that their potential to bioaccumulate is
unknown. EPA estimates that the anion of P-25-4 will persist in the
environment for more than six months and that its potential to
bioaccumulate is unknown. EPA estimates that the cation
photodegradation products of P-25-3 and P-25-4 will persist in the
environment for more than six months and estimates a bioaccumulation
factor greater than 5,000. Based on comparison to analogous sulfonium
compounds, EPA has identified concerns for acute toxicity, irritation
to the skin and respiratory tract, eye corrosion, neurological effects,
and systemic effects for the sulfonium cations of the PMN substances.
Based on the photoreactivity of the cations of the PMN substances, EPA
has also identified concerns for photosensitization. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for genetic toxicity. Based on insufficient information, the
anions of the PMN substances have unknown toxicity. Based on
insufficient information, the PMN substances have unknown toxicity to
aquatic organisms. 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
or the environment. To protect against these risks, the Order requires:
No manufacture of the PMN substances 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 and environmental precautionary statements on each label
and in the SDS;
No processing of the PMN substances in any way that
generates a dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
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 substances 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.
P-25-16 (40 CFR 721.12215)
Chemical Name: Trihaloaromatmic iodonium dicyclo salt with
polyhaloalkyl carbomonocycle hetero-acid (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 2, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for photoacid generator
use at customer sites. 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 1999) and in the absence of data, the cation
and anion of the PMN substance, and the cation photolysis product are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the anion and cation will persist in the
[[Page 49193]]
environment for more than six months and that the potential to
bioaccumulate is unknown. EPA estimates that the cation 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.
Based on comparison to analogous chemical substances, EPA has
identified concerns for acute toxicity, skin irritation, and systemic
and reproductive (developmental) toxicity for the anion. Based on OECD
QSAR Toolbox alerts, EPA has also identified concerns for skin and
respiratory sensitization for the anion. Based on OECD QSAR Toolbox
alerts and Oncologic results, EPA has also identified concerns for
carcinogenicity for the anion. Due to insufficient information, EPA was
unable to estimate the hazards of the cation. Based on the
photoreactivity of the PMN substance, EPA has also identified concerns
for photosensitization. Based on comparison to analogous chemical
substances, EPA also identified concerns for genetic toxicity. 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 and environmental precautionary statements on each label
and in the SDS;
No processing of the PMN substance in any way that
generates a 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, unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
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.
P-25-20 (40 CFR 721.12216) and P-25-21 (40 CFR 721.12217)
Chemical Names: Sulfonium, triphenyl-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic) (P-25-20)
and sulfonium, tri(halosubstitutedphenyl)-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic) (P-25-21).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: February 4, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the PMN substances will be for contained use for
microlithography for electronic device manufacturing. 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 1999) and
test data on structurally similar substances, the anion and the cation
photodegradation product of the P-25-20 substance and the cation,
anion, and cation photodegradation product of the P-25-21 substance are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the anion of P-25-20 and the anion and cation of P-25-21
will persist in the environment for more than six months and that their
potential to bioaccumulate is unknown. EPA estimates that the cation
photodegradation products of P-25-20 and P-25-21 will persist in the
environment for more than six months and estimates a bioaccumulation
factor greater than 5,000. Based on comparison to analogous sulfonium
compounds, EPA has identified concerns for acute toxicity, irritation
to the skin, eyes, and respiratory tract, eye corrosion, neurological,
and systemic effects for the sulfonium cations of the PMN substances.
Based on the photoreactivity of the PMN substances, EPA has also
identified concerns for photosensitization. Based on comparison to
analogous chemical substances, EPA also identified concerns for genetic
toxicity for the cations of the PMN substances. Based on OECD Toolbox
results, EPA has also identified concerns for skin sensitization for
the anion. Due to insufficient information, EPA was unable to estimate
the environmental hazard of the PMN 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 or the environment. To protect against these
risks, the Order requires:
No manufacture of the PMN substances 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 substances in any way that
generates dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
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 substances 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
[[Page 49194]]
specified in the Order without performing the required Tier I and Tier
II testing outlined in the Testing section of the Order.
P-25-67 (40 CFR 721.12218)
Chemical Name: Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-
, salt with trihalobenzoate (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: May 19, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. 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 1999) and in the
absence of data, the cation and anion of the PMN substance, and the
cation photodegradation product are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the
anion and cation of the PMN substance will persist in the environment
for more than six months and that their potential to bioaccumulate is
unknown. EPA estimates that the cation photodegradation product 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
comparison to analogous sulfonium compounds, EPA has identified
concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, eye corrosion, neurological, and systemic effects
for the sulfonium cation. Based on photoreactivity, EPA has also
identified concerns for photosensitization. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
genetic toxicity for the cation of the PMN substance. Based on OECD
Toolbox results, EPA has also identified concerns for skin
sensitization for the anion of the PMN substance. 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 and environmental precautionary statements on each label
and in the SDS;
No processing of the PMN substance in any way that
generates 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 unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
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 is exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
EPA always welcomes your feedback on the burden estimates. When
submitting comments on these proposed SNURs, include comments about the
accuracy of the burden estimate, and any suggested methods for
improving the collection instruments or instruction or minimizing
respondent burden, including through the use of automated collection
techniques.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or 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,
[[Page 49195]]
if any, there may be. However, EPA's experience to date is that, in
response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was 9 in fiscal year (FY) 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 $14,967 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. 721.12184 through 721.12218 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.12184 Heteroaromatic substituted alkanoic acid, [2,2-
bis[[(1-oxo-2-propen-1-yl)oxy]methyl]- 1,3-propanediyl] ester, dioxide
homopolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteroaromatic substituted alkanoic acid, [2,2-bis[[(1-oxo-2-propen-1-
yl)oxy]methyl]- 1,3-propanediyl] ester, dioxide homopolymer (PMN P-18-
104) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been entrained in the plastic article.
(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: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized
[[Page 49196]]
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance other than by import
into the United States (i.e., no domestic manufacture) and only if the
concentration of the substance in formulation does not exceed the
confidential percentage by weight listed in the Order. It is a
significant new use to use the substance other than as a halogen-free
flame retardant for use in thermoplastic polymers.
(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. 721.12185 Ethanol, 2,2-difluoro-, 1-acetate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanol, 2,2-
difluoro-, 1-acetate (PMN P-18-413; CASRN: 1550-44-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the chemical substance after they have been
completely entrained in a sealed battery or sealed supercapacitor,
unless or until the article has been shredded or processed such that
exposure to the chemical substance occurs.
(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: reproductive
toxicity, specific target organ toxicity, skin corrosion, and serious
eye damage. 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).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=554.
(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. 721.12186 Heterocyclic epoxide polymer with mixed substituted
glycols and acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterocyclic epoxide polymer with mixed substituted glycols and acid
anhydride (PMN P-21-88) 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 (i.e., the
substance has been reacted or cured 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) 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: acute
toxicity, skin irritation, serious eye damage, eye irritation,
respiratory sensitization, skin sensitization, genetic 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. It is a
significant new use to manufacture the substance as a solid without the
use of a fume hood, dust collector, or other engineering controls with
at least 25% combined capture and removal efficiency of aggregate
releases of the total process, unless in an enclosed process. It is a
significant new use to process or use the substance as a solid without
the use of a fume hood, dust collector, or other engineering controls
with at least 25% combined capture and removal efficiency, unless in an
enclosed process.
(iv) Disposal. It is a significant new use to dispose of the
substance or waste streams containing the substance other than by
incineration or hazardous waste landfill in compliance with RCRA
subtitle C.
(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. 721.12187 Pyridinium, 3-carboxy-1-methyl-, inner salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pyridinium, 3-
carboxy-1-methyl-, inner salt (PMN P-21-215; CASRN 535-83-1) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
completely destroyed.
(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
[[Page 49197]]
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: 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). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=770.
(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. 721.12188 Polyol allyl ether, homopolymer terpene ether and
polyol allyl ether, homopolymer, alkyl ethers (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, homopolymer terpene ether and polyol allyl ether,
homopolymer, alkyl ethers (PMN P-22-60) 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 completely reacted, cured, or
incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, skin irritation, serious eye damage, eye
irritation, 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) 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. 721.12189 Polyol allyl ether, homopolymer terpene ether and
polyol allyl ether, homopolymer, alkyl ethers (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, homopolymer terpene ether and polyol allyl ether,
homopolymer, alkyl ethers (PMN P-22-61) 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 completely reacted, cured, or
incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, skin irritation, serious eye damage, eye
irritation, 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) 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. 721.12190 Polyol allyl ether, polymer with alkylene oxides,
terpene ether and Polyol allyl ether, polymer with alkylene oxides,
alkyl ethers (generic) (P-22-64).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, polymer with alkylene oxides, terpene ether and polyol
allyl ether, polymer with alkylene oxides, alkyl ethers (PMN P-22-64)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance when completely
reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When
[[Page 49198]]
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, skin irritation, serious eye damage, eye
irritation, 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) 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. 721.12191 Polyol allyl ether, polymer with alkylene oxides,
terpene ether and Polyol allyl ether, polymer with alkylene oxides,
alkyl ethers (generic) (P-22-65).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, polymer with alkylene oxides, terpene ether and polyol
allyl ether, polymer with alkylene oxides, alkyl ethers (PMN P-22-65)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance when completely
reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, skin irritation, serious eye damage, eye
irritation, 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) 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. 721.12192 Polyol allyl ether, polymer with alkylene oxides,
terpene ether sulfate, ammonium salt and Polyol allyl ether, polymer
with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-
22-66).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, polymer with alkylene oxides, terpene ether sulfate,
ammonium salt and polyol allyl ether, polymer with alkylene oxides,
alkyl ether sulfate, ammonium salts (PMN P-22-66) 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 completely reacted,
cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, 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) 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.
[[Page 49199]]
Sec. 721.12193 Polyol allyl ether, polymer with alkylene oxides,
terpene ether sulfate, ammonium salt and Polyol allyl ether, polymer
with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-
22-67).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
allyl ether, polymer with alkylene oxides, terpene ether sulfate,
ammonium salt and polyol allyl ether, polymer with alkylene oxides,
alkyl ether sulfate, ammonium salts (PMN P-22-67) 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 completely reacted,
cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, 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) 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. 721.12194 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester,
reaction products with 2-oxepanone homopolymer 2-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]ethyl] ester and phosphorous oxide (P2O5).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, 2-hydroxyethyl ester, reaction products with 2-oxepanone
homopolymer 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl] ester and
phosphorous oxide (P2O5) (PMN P-22-153; CASRN 2548699-72-3) 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: skin
irritation, serious eye damage, respiratory sensitization, skin
sensitization, carcinogenicity, 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(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=3.
(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. 721.12195 Alkyl acid, 2-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-, methyl substituted alkyl ester (PMN P-22-165) 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: serious eye
damage, 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).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=231.
(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 49200]]
Sec. 721.12196 Cysteine, cyclic alkyl, ethyl ester; alkylthio ketone
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cysteine, cyclic alkyl, ethyl ester; alkylthio ketone (PMN P-23-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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 (degradation product), 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. It is a
significant new use to manufacture or process 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 a
consumer product unless the concentration does not exceed 0.1% by
weight in the consumer product.
(iv) Disposal. It is a significant new use to land apply the
substance, or waste streams containing the substance, to agricultural
lands.
(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. 721.12197 Cysteine, cyclic alkyl, ethyl ester; alkylthio ketone
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cysteine, cyclic alkyl, ethyl ester; alkylthio ketone (PMN P-23-10) 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 (degradation product), skin irritation (degradation product),
eye irritation (degradation product), skin sensitization, reproductive
toxicity (degradation product), 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 or process 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 a
consumer product unless the concentration does not exceed 1% by weight
in the consumer product.
(iv) Disposal. It is a significant new use to land apply the
substance, or waste streams containing the substance, to agricultural
lands.
(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. 721.12198 1,3-Propanediol, polymer with 1,3-
diisocyanatomethylbenzene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-propanediol,
polymer with 1,3-diisocyanatomethylbenzene (PMN P-23-32; CASRN 67517-
96-8) 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), 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, 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(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.
[[Page 49201]]
Sec. 721.12199 Glycerides from fermentation of genetically modified
microorganism, ethoxylated, reaction products with ethanol, polycyclic
isocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycerides from fermentation of genetically modified microorganism,
ethoxylated, reaction products with ethanol, polycyclic isocyanate (PMN
P-23-118) 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 (i.e., the
substance has been reacted or cured 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: eye irritation, respiratory
sensitization, 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(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. It is a significant new use to
manufacture the substance in a formulation unless the percentage of the
confidential unreacted substance listed in the Order does not exceed
the confidential percentage by weight listed in the Order.
(iv) Disposal. It is a significant new use to dispose of the
substance in any manner that results in inhalation exposure to the
substance. It is a significant new use to dispose of the substance
other than by hazardous waste incineration and the disposal must be at
a facility that is in compliance with RCRA subtitle C.
(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 (j) 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. 721.12200 Alkenal, 9-(acetyloxy)-, (E)- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenal, 9-(acetyloxy)-, (E)- (PMN P-23-142; Accession No. 302751) 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), this substance may cause: skin
irritation, 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. Requirements
as specified in Sec. 721.80(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. 721.12201 Cellulose, alkoxyalkyl ether, alkali metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cellulose, alkoxyalkyl ether, alkali metal salt (PMN P-23-173;
Accession No. 303061) 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 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 (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.
(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: 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).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=120.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 49202]]
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. 721.12202 Benzoylated amino acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzoylated amino acid salt (PMN P-24-4) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured (i.e., the substance has been reacted or cured 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) 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: 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(k) and (t).
(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. 721.12203 Alkylated succinimide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylated succinimide (PMN P-24-79) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new 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: 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 or process the substance in any manner that results in
inhalation exposure to the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance in any manner that results in inhalation exposure to the
substance. It is a significant new use to dispose of the substance, or
waste streams containing the substance, other than by hazardous waste
incineration in compliance with RCRA, including RCRA subtitle C.
(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. 721.12204 2-Propenoic acid, 3-bromo-2,2-bis(bromomethyl)propyl
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
3-bromo-2,2-bis(bromomethyl)propyl ester (PMN P-24-82; CASRN 3217-37-6)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substances when completely
reacted or cured (i.e., the substance has been reacted or cured 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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, respiratory sensitization, skin corrosion, skin
sensitization, serious eye damage, 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(o). It is a significant new use to
manufacture the substance other than by import into the United States
in ink cartridges (i.e., no domestic manufacture). It is a significant
new use to process or use the substance in any manner that results in
inhalation exposure to the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or cartridges or waste steams containing the substance,
other than by hazardous waste incineration in compliance with RCRA. It
is a significant new use to dispose of the substance in any manner that
results in inhalation exposure to the substance.
[[Page 49203]]
(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. 721.12205 Siloxanes and Silicones, di-Me, 3-[[[[4-[(4-
isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl
group-terminated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, di-Me, 3-[[[[4-[(4-
isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl
group-terminated (PMN P-24-85; CASRN 1411848-76-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured (i.e., the substance has been reacted or
cured 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, eye irritation,
respiratory sensitization, 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(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. 721.12206 Polyester polymer with polyether polymer and 1,1'-
methylenebis(4-isocyanatobenzene) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polymer with polyether polymer and 1,1'-methylenebis(4-
isocyanatobenzene) (PMN P-24-102) 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 (i.e., the substance has been reacted or cured 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: skin irritation, eye
irritation, respiratory sensitization, 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). 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. 721.12207 Polyester polymer with polyether polymer and 1,1'-
methylenebis(isocyanatobenzene) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polymer with polyether polymer and 1,1'-
methylenebis(isocyanatobenzene) (PMN P-24-103) 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 (i.e., the substance has been reacted or cured 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: skin irritation, eye
irritation, respiratory sensitization, 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). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
[[Page 49204]]
(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. 721.12208 Alkanoic acid, mercapto-, ((((mercapto-oxoalkoxy)-
(mercapto-oxoalkoxy)alkyl)alkoxy)alkyl)-((mercapto-oxoalkoxy)alkyl)-
alkanediyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, mercapto-, ((((mercapto-oxoalkoxy)-(mercapto-
oxoalkoxy)alkyl)alkoxy)alkyl)-((mercapto-oxoalkoxy)alkyl)-alkanediyl
ester (PMN P-24-129) 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 (i.e., the
substance has been reacted or cured 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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
sensitization, acute toxicity, respiratory 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=1.6.
(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.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12209 Sulfonium, triphenyl-, salt with fluorosulfoalkyl-
fluoroalkyl substituted-heterotricycloalkane-carboxylate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with fluorosulfoalkyl-fluoroalkyl
substituted-heterotricycloalkane-carboxylate (1:1) (PMN P-24-185) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(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, genetic toxicity, skin irritation,
skin sensitization, serious eye damage, 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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12210 Heteroonium, tri(substitutedaromatichydrocarbon)-,
nitrate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteroonium, tri(substitutedaromatichydrocarbon)-, nitrate (1:1) (PMN
P-25-28) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2) (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 0.1%. For purposes of Sec. 721.72(g)(1), this
[[Page 49205]]
substance may cause: acute toxicity, carcinogenicity, reproductive
toxicity, genetic toxicity, skin irritation, skin sensitization,
serious eye damage, 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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12211 Alkyl transition metal alkoxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
transition metal alkoxide (PMN P-24-187) 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 destroyed.
(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
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). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol outside of a fully enclosed system
containing 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. 721.12212 Silsesquioxanes, alkyl Ph
alkoxy(halosubstitutedphenyl), polymers with silicic acid (H4SiO4)
tetra-Me ester, hydroxy-terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
silsesquioxanes, alkyl Ph alkoxy(halosubstitutedphenyl), polymers with
silicic acid (H4SiO4) tetra-Me ester, hydroxy-terminated (PMN P-24-189)
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: acute 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.
(ii) 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.
(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. 721.12213 Phenoxathiinium, 10-phenyl-,
tricycloalkylcarbomonocyclesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenoxathiinium, 10-phenyl-, tricycloalkylcarbomonocyclesulfonate (1:1)
(PMN P-25-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new
[[Page 49206]]
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 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12214 Sulfonium, triphenyl-, heteropolyclyclecarboxylate
(1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, heteropolyclyclecarboxylate (1:1) (PMN P-25-4)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12215 Trihaloaromatic iodonium dicyclo salt with
polyhaloalkyl carbomonocycle hetero-acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trihaloaromatic iodonium dicyclo salt with polyhaloalkyl carbomonocycle
hetero-acid (PMN P-25-16) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted or adhered
(during photolithographic processes) onto a semiconductor wafer surface
or similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 0.1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin 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(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12216 Sulfonium, triphenyl-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (PMN P-25-20) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures)
[[Page 49207]]
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), (g)(2)(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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12217 Sulfonium, tri(halosubstitutedphenyl)-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tri(halosubstitutedphenyl)-, salt with
heterosubstituteddifluorosubstitutedalkyl substitutedalkyl
trihalosubstitutedcarbomonocycle carboxylate (1:1) (PMN P-25-21) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(2)(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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12218 Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-,
salt with trihalobenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(dihalo carbomonocycle)carbomonocycle-, salt with
trihalobenzoate (PMN P-25-67) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
adhered (during photolithographic processes) onto a semiconductor wafer
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(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), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 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. 2025-19757 Filed 10-31-25; 8:45 am]
BILLING CODE 6560-50-P