[Federal Register Volume 90, Number 210 (Monday, November 3, 2025)]
[Proposed Rules]
[Pages 49016-49044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19755]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0514; FRL-12730-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (25-
1.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs) and are also
subject to an Order issued by EPA pursuant to TSCA. The SNURs require
persons who intend to manufacture (defined by statute to include
import) or process any of these chemical substances for an activity
that is proposed as a significant new use by this rulemaking to notify
EPA at least 90 days before commencing that activity. The required
notification initiates EPA's evaluation of the conditions of that use
for that chemical substance. In addition, the manufacture or processing
for the significant new use may not commence until EPA has conducted a
review of the required notification, made an appropriate determination
regarding that notification, and taken such actions as required by that
determination.
DATES: Comments must be received on or before December 3, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0514, online at https://www.regulations.gov.
[[Page 49017]]
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: Joseph Said, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-0848; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information on TSCA: The TSCA Assistance Information
Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-
1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in
Unit III. These SNURs, if finalized as proposed, would require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed rule. The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40
CFR part 707, subpart B). Importers of chemical substances in bulk
form, as part of a mixture, or as part of an article (if required by
rule) must certify that the shipment of the chemical substance complies
with all applicable rules and orders under TSCA, including regulations
issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after December 3, 2025 are subject to TSCA section 12(b) (15
U.S.C. 2611(b)) and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)). The costs of submission for SNUNs will not
be incurred by any company unless a company decides to pursue a
significant new use as defined in these SNURs. Additionally, these
estimates reflect the costs and fees as they are known at the time of
this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
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.
[[Page 49018]]
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 wants:
To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying TSCA Orders,
consistent with TSCA section 5(f)(4).
To have an opportunity to review and evaluate data
submitted in a SNUN before the submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Chemical
Substance Inventory (TSCA Inventory). Guidance on how to determine if a
chemical substance is on the TSCA Inventory is available at https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR parts 2 and 703. Absent a final determination or other
disposition of the confidentiality claim under these regulations, EPA
is required to keep this information confidential. EPA promulgated a
procedure at 40 CFR 721.11 to deal with the situation where a specific
significant new use is CBI. Under these procedures, a manufacturer or
processor may ask EPA to identify the confidential significant new use
subject to the SNUR. The manufacturer or processor must show that it
has a bona fide intent to manufacture or process the chemical
substance. If EPA concludes that the person has shown a bona fide
intent to manufacture or process the chemical substance, EPA will
identify the confidential significant new use to that person. Since
most of the chemical identities of the chemical substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in 40 CFR 721.11 into a single
step.
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.
[[Page 49019]]
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also https://www.epa.gov/tsca-import-export-requirements.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review and received determinations under
TSCA section 5(a)(3)(C). TSCA Orders have been issued for these
chemical substances and the PMN submitters are required by the TSCA
Orders to submit a SNUN before undertaking activities that would be
designated as significant new uses in these SNURs. Additionally, the
identities of many of the chemical substances subject to this proposed
rule have been claimed as confidential per 40 CFR 720.85, further
reducing the likelihood that another party would manufacture or process
the substances for an activity that would be designated as a
significant new use. Based on this, the Agency believes that it is
highly unlikely that any of the significant new uses identified in Unit
III. are ongoing.
When the chemical substances identified in Unit III. are added to
the TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. Persons who begin manufacture or processing of the
chemical substances for a significant new use identified on or after
the designated cutoff date specified in Unit III.A. would have to cease
any such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and EPA would have to take
action under TSCA section 5 allowing manufacture or processing to
proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, TSCA order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to or reasonably ascertainable by
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the
Agency has the authority to require appropriate testing. To assist with
EPA's analysis of the SNUN, submitters are encouraged, but not
required, to provide the potentially useful information as identified
for the chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit III. may not
be the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA sections 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
III. Chemical Substances Subject to these Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates November 3, 2025 as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
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).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual
[[Page 49020]]
measurements of the workplace air show that air-borne concentrations of
the PMN substance are below a New Chemical Exposure Limit (NCEL). The
comprehensive NCELs provisions in TSCA Orders include requirements
addressing performance criteria for sampling and analytical methods,
periodic monitoring, respiratory protection, and recordkeeping. No
comparable NCEL provisions currently exist for SNURs in 40 CFR part
721, subpart B. Therefore, for these cases, the individual SNURs in 40
CFR part 721, subpart E, will state that persons subject to the SNUR
who wish to pursue NCELs as an alternative to the 40 CFR 721.63
respirator requirements may request to do so under 40 CFR 721.30. EPA
expects that persons whose 40 CFR 721.30 requests to use the NCELs
approach for SNURs that are approved by EPA will be required to comply
with NCELs provisions that are comparable to those contained in the
corresponding TSCA Order.
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are
as follows, listed by PMN number and with the proposed CFR citation:
P-20-138 (40 CFR 721.12112)
Chemical name: Alkane diglycidyl ether, polymer with alkyl-
cycloalkane diamines (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: October 11, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
curing agent for a 2-part epoxy adhesive formulation used to make
composite structures for industries such as marine, automotive, and
wind energy. Based on test data on a residual and the structure of the
PMN substance, EPA has identified concerns for acute toxicity, skin,
eye, and respiratory tract irritation and corrosion, skin
sensitization, respiratory tract/pulmonary effects, systemic effects,
and reproductive/developmental effects. Based on comparison to
analogous polycationic polymers, 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:
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
No processing for use or use of the PMN substance in a
consumer product;
No use of the PMN substance in any manner that is a spray
application;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 1 ppb;
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 acute
toxicity, eye irritation/corrosion, skin irritation/corrosion, skin
sensitization, pulmonary effects, specific target organ toxicity,
reproductive toxicity, developmental toxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-21-101 (40 CFR 721.12113)
Chemical name: Benzenesulfonic acid, polyalkyl derivs., calcium
salts (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: October 22, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a lubricant and lubricant additive. Based
on comparison to analogous chemical substances, EPA has identified
concerns for skin, eye, and respiratory tract irritation, skin
sensitization, local (stomach irritation) effects, 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:
Processing for use and use of the PMN substance only for
the confidential use listed in the Order;
No processing for use or use of the PMN substance in a
consumer product;
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; 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, skin sensitization, and
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-22-68 (40 CFR 721.12114)
Chemical name: 2-Propanamine, 1,1'-[(1-
methylethylidene)bis(oxy)]bis-.
CASRN: 2267262-12-2.
Effective date of TSCA Order: October 22, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
epoxy component used in a reaction with other components to produce an
epoxy article. Based on submitted test data on the PMN substance, EPA
has identified concerns for skin, eye, and respiratory tract corrosion.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for skin sensitization, acute toxicity, systemic
effects, and reproductive and developmental effects. Based on the
weight of the scientific evidence, EPA has also identified concerns for
respiratory sensitization. Based on
[[Page 49021]]
comparison to analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 260 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
No processing for use or use of the PMN substance in a
consumer product;
Use of a NIOSH-certified respirator with an APF of at
least 50 (or 1,000 if spray applied) 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 hazardous waste incineration;
Notwithstanding the disposal restriction in the order, no
release of the PMN substance, or any waste stream containing the PMN
substance, resulting in surface water concentrations that exceed 60
ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
corrosion, eye irritation/corrosion, skin sensitization, acute
toxicity, specific target organ toxicity, reproductive toxicity, and
developmental toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-22-95 (40 CFR 721.12115), P-22-96 (40 CFR 721.12116), P-22-97 (40 CFR
721.12117), P-22-98 (40 CFR 721.12118), P-22-99 (40 CFR 721.12119), and
P-22-100 (40 CFR 721.12120)
Chemical names: Glycolipids, sophorose-contg., yeast-fermented,
from glycerides and carbohydrates (generic) (P-22-95, P-22-96, P-22-97,
P-22-98, P-22-99, and P-22-100).
Accession Nos.: 302897 (P-22-95); not available (P-22-96, P-22-97,
P-22-98, P-22-99, and P-22-100).
Effective date of TSCA Order: October 11, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as surfactants for consumer, commercial, and
industrial applications. Based on submitted test data on the PMN
substances, EPA has identified concerns for eye irritation. Based on
comparison to analogous chemical substances and the surfactant
properties of the PMN substances, EPA has also identified concerns for
respiratory tract irritation and lung effects. Based on comparison to
analogous chemical substances, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 550 ppb. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
No processing for use or use of the PMN substances at a
concentration of 3% or greater by weight in formulation in a consumer
product;
No use of the PMN substances for commercial or industrial
use at greater than the confidential percentage by weight in
formulation listed in the Order;
No use of the PMN substances in spray applications unless
contained in an enclosed process, except for the confidential use
listed in the Order;
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 or
compliance with a NCEL of 0.0078 mg/m\3\ as an 8-hour time-weighted
average to prevent inhalation exposure;
No release of the PMN substances, or any waste stream
containing the PMN substances, resulting in surface water
concentrations that exceed 550 ppb of the PMN substances in aggregate;
and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN 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-22-116 (40 CFR 721.12121)
Chemical name: Carbopolycycle octa-alkene, alkenylaryloxy-
(generic).
Accession No.: 303094.
Effective date of TSCA Order: November 25, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a monomer. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-6097-7))
and test data on structurally similar substances, the PMN substance is
a potentially 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 1,000. Based on
comparison to analogous chemical substances, EPA has identified
concerns for acute toxicity, skin, eye, and respiratory tract
irritation, skin sensitization, pulmonary, neurological, reproductive,
and systemic effects, genetic toxicity, and carcinogenicity. Based on
OECD QSAR Toolbox Alert, EPA has also identified concerns for
respiratory sensitization. Based on comparison to analogous neutral
organics, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 5 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To
[[Page 49022]]
protect against these risks, the Order requires:
No manufacture of the PMN substance above the confidential
annual production volume listed in the Order;
No manufacture, processing, or use of the PMN substance
without capture of all airborne releases of the PMN substance resulting
from manufacture, processing, or use and either landfill, incinerate,
or route through a HEPA filtration system with a minimum control
efficiency of 90%;
Use of the PMN substance only for the confidential use
listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
Use of a NIOSH-certified particulate respirator with an
APF of at least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, carcinogenicity, eye irritation/corrosion, genetic toxicity,
neurotoxicity, pulmonary effects, reproductive toxicity, skin
irritation, skin sensitization, specific target organ toxicity,
persistence, bioaccumulation, and aquatic toxicity testing may be
potentially useful to characterize the health, environmental fate, 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-22-143 (40 CFR 721.12122)
Chemical name: Acetamide, N-[3-[alkyl(carbomonocyclic)
substituted]carbomonocycle]-, coupled with diazotized 2-substituted-3-
halo-5-nitrobenzonitrile (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: September 14, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
exhaust dyeing of cotton and cotton blends. Based on comparison to
analogous chemical substances, EPA has identified concerns for systemic
effects. Based on comparison to analogous anilines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
Import of the PMN substance into the United States (i.e.,
no domestic manufacture) only below the confidential annual volume
listed in the Order;
No 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;
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, in surface water concentrations that
exceed 2 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, genetic toxicity, carcinogenicity, 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-22-168 (40 CFR 721.12123)
Chemical name: Amides, alkyl, N-[3-(dimethylamino)propyl]
(generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: November 27, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
chemical intermediate for surfactant end-products. Based on comparison
to analogous chemical substances and submitted test data on the PMN
substance, EPA has identified concerns for acute toxicity, skin
corrosion, point-of-contact effects, and systemic effects. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for eye corrosion. Based on comparison to analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No manufacture, processing, or use of the PMN substance
other than in liquid form;
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, in surface water concentrations that
exceed 2 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation/corrosion, pulmonary effects, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA
[[Page 49023]]
based on submission of this or other relevant information.
P-22-186 (40 CFR 721.12124)
Chemical name: Phosphoric acid, dialkyl ester, transition metal
salt (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: September 19, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an oil additive. Based on submitted test
data on the PMN substance, EPA has identified concerns for eye and skin
irritation, systemic effects, reproductive and developmental effects,
and lung effects (surfactancy). Based on submitted test data on the PMN
substance and comparison to analogous chemical substances, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
32 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:
Processing for use or use of the PMN substance in a
consumer product only if the concentration of the PMN substance does
not exceed the confidential concentration by weight listed in the Order
in the consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 32 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, neurotoxicity, pulmonary effects, reproductive/
developmental toxicity, skin irritation, and specific target organ
toxicity testing may be potentially useful to characterize the health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
P-23-16 (40 CFR 721.12125)
Chemical name: 2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-.
CASRN: 2337348-25-9.
Effective date of TSCA Order: October 16, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for paints, UV inks, coatings,
etc. Based on comparison to analogous chemical substances, EPA has
identified concerns for systemic effects. Based on submitted test data
on the PMN substance, EPA has also identified concerns for respiratory,
skin, and eye irritation, and skin sensitization. Based submitted test
data on the PMN substance, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 230 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:
Processing for use or use of the PMN substance in a
consumer product only if the concentration of the PMN substance is less
than 1% by weight in the consumer product;
Processing for use or use of the PMN substance in an
industrial or commercial product only if the concentration of the PMN
substance is less than or equal to 2% by weight in the industrial or
commercial product;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 230 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity and chronic 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-23-47 (40 CFR 721.12126)
Chemical name: Heteromonocyclic, dialkyl amide, substituted alkyl
salt (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: December 17, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive in plating baths. Based on
test data for a potential metabolite, EPA has identified concerns for
reproductive 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;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance in a
consumer product;
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 1600 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will
[[Page 49024]]
be designated by this SNUR. EPA has determined that the results of
reproductive toxicity testing may be potentially useful to characterize
the health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-23-87 (40 CFR 721.12127)
Chemical name: Oxirane, 2-methyl-, polymer with 2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane, monoether with .alpha.-
butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)].
CASRN: 1973415-03-0.
Effective date of TSCA Order: October 31, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
adhesive and sealant for various applications. Based on comparison to
analogous chemical substances, EPA has identified concerns for acute
toxicity, systemic effects, and irritation to the skin, eyes, and
respiratory tract. Based on the reactivity of the PMN substance, EPA
has also identified concerns for irritation to skin, eyes, and
respiratory tract. Based on comparison to analogous alkoxysilanes, EPA
has also identified concerns for 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 processing for use or use of the PMN substance in a
consumer product unless the concentration of the PMN substance is less
than 3% (by weight) in the consumer product;
No use of the PMN substance in a commercial or industrial
product unless the concentration of the PMN substance in the product
does not exceed the confidential percentage (by weight) listed in the
Order;
No spray application of the PMN substance unless done in
an enclosed process;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; 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
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-127 (40 CFR 721.12128)
Chemical name: Polysaccharide lyase (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: December 6, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
ingredient in laundry detergent that is used for degradation of stains
on fabric. Based on comparison to analogous chemical substances, EPA
has identified concerns for respiratory sensitization. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 98 ppb if not
deactivated. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the Order requires:
Manufacture of the PMN substance only in liquid solution;
Processing and use of the PMN substance only in a liquid
formulation;
Processing for use and use of the PMN substance only for
use as an ingredient in laundry detergent that is used for degradation
of stains on fabric;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States if the
PMN substance is not deactivated before releasing 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
pulmonary effects and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-130 (40 CFR 721.12129)
Chemical name: Fatty acids reaction products with
polyalkylpolyamines, salts (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: January 16, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in asphalt. Based on structure
and intended use, EPA has identified concerns for lung toxicity
(surfactant effects). Based on comparison to analogous chemical
substances, EPA has also identified concerns for skin sensitization and
irritation, eye irritation, and systemic effects. Based on comparison
to analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 0.7 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;
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;
Manufacture, processing, or use of the PMN substance only
in liquid or asphalt formulation;
No release of the PMN substance, or any waste stream
containing the PMN
[[Page 49025]]
substance, into waters of the United States; 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, 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-23-133 (40 CFR 721.12130)
Chemical name: Fatty acids reaction products with alcoholamine
reaction by-products, salts (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: January 16, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in asphalt. Based on the
physical/chemical properties of the PMN substance (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 4, 1999
(FRL-6097-7)) and test data on structurally similar substances, the PMN
substance is a potentially 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 1,000.
Based on structure and intended use, EPA has identified concerns for
lung toxicity (surfactant effects). Based on comparison to analogous
chemical substances, EPA has also identified concerns for eye
irritation, skin corrosion, skin sensitization, and systemic effects.
Based on comparison to analogous aliphatic amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
0.039 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;
Manufacture, processing, or use of the PMN substance only
in liquid or asphalt formulation;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
bioaccumulation, eye irritation, pulmonary effects, skin corrosion,
skin sensitization, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the fate,
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-23-134 (40 CFR 721.12131)
Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
hydro-.omega.-[[2-[(1-chloro-9-oxo-9H-thioxanthen-4-yl)oxy]acetyl]oxy]-
, ether with 2,2-bis(hydroxymethyl)-1,3-propanediol (4:1).
CASRN: 1003567-83-6.
Effective date of TSCA Order: July 15, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a photoinitiator for UV curing of
monomeric and oligomeric acrylate-based printing inks. Based on
comparison to analogous chemical substances to the residual, EPA has
identified concerns for eye corrosion. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Manufacture of the PMN substance only below a molecular
weight of 10,000 Daltons;
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
corrosion 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-23-144 (40 CFR 721.12132)
Chemical name: L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., calcium
salts.
CASRN: 1917323-93-3.
Effective date of TSCA Order: September 21, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
retarder for use in gypsum-based construction materials. Based on
submitted test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 405 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 the environment. To protect against
these risks, the Order requires:
No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 405 ppb; and
[[Page 49026]]
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
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-23-149 (40 CFR 721.12133)
Chemical name: Dialkyltin fatty acids ester (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: November 18, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
catalyst. Based on comparison to analogous organotins, EPA has
identified concerns for systemic effects (including neurological and
immunological) and acute toxicity. Based on comparison to analogous
chemical substances, EPA has also identified concerns for developmental
effects. Based on comparison to analogous organotin compounds, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 47 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
Manufacture or processing of the PMN substance only in a
manner that does not generate vapor, mist, dust, or aerosol containing
the PMN substance;
Use of the PMN substance only if the concentration of the
PMN substance does not exceed 1.0% by weight in formulation;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States; 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, neurological effects, reproductive/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-23-166 (40 CFR 721.12134)
Chemical name: Polypropylene glycol allyloxymethyl acrylate
(generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: January 8, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a monomer for UV curable application.
Based on submitted test data on the PMN substance, EPA has identified
concerns for skin irritation. Based on comparison to analogous chemical
substances, EPA has also identified concerns for acute toxicity, skin
sensitization, systemic effects, and respiratory sensitization. Based
on comparison to analogous acrylates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 10 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 10 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization, acute toxicity, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-167 (40 CFR 721.12135)
Chemical name: Bisalkyldiacid fluorophosphate salt (generic).
Accession No.: 302773.
Effective date of TSCA Order: July 15, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in battery production. Based on submitted
test data on the PMN substance, EPA has identified concerns for acute
toxicity, neurotoxicity, skin irritation, eye corrosion, skin
sensitization, and systemic effects. Based on test data for hydrolysis
products, EPA has also identified concerns for skeletal fluorosis and
respiratory tract corrosion. Based on test data for the cation, EPA has
also identified concerns for neurotoxicity, systemic, reproductive, and
developmental effects. Based on submitted test data on the PMN
substance and comparison to analogous chemical substances, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
53 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
[[Page 49027]]
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Notwithstanding the disposal restriction in the order, no
release of the PMN substance, or any waste stream containing the PMN
substance, resulting in surface water concentrations that exceed 53
ppb;
Disposal of the PMN substance, or any waste stream
containing the PMN substance, only by incineration;
Use of personal protective equipment where there is a
potential for dermal exposure; 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 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-23-168 (40 CFR 721.12136)
Chemical name: Sulfamide fluorophosphate salt (generic).
Accession No.: 303038.
Effective date of TSCA Order: August 9, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in battery production. Based on the physical/
chemical properties of the PMN substance (as described in the New
Chemical Program's PBT category at 64 FR 60194; November 4, 1999 (FRL-
6097-7)) and test data on structurally similar substances, the PMN
substance hydrolysis product is a potentially PBT chemical. EPA
estimates that the PMN substance hydrolysis product will persist in the
environment for more than six months and has unknown bioaccumulation
potential. Based on submitted test data on the PMN substance, EPA has
identified concerns for acute toxicity and skin, eye, and respiratory
tract corrosion. Based on comparison to analogous chemical substances,
EPA has also identified concerns for neurotoxicity, systemic effects,
and reproductive and developmental effects for the hydrolysis products.
Based on comparison to analogous phosphates inorganic and submitted
test data on the PMN substance, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Disposal of the PMN substance, or any waste stream
containing the PMN substance, by incineration;
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, eye irritation/corrosion, neurotoxicity, pulmonary effects,
reproductive toxicity, developmental toxicity, and specific target
organ toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-178 (40 CFR 721.12137)
Chemical name: Benzenamine, 4,4'-(9H-fluoren-9-ylidene)bis-.
CASRN: 15499-84-0.
Effective date of TSCA Order: January 1, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
ingredient in lens resins for photoelectric conversion adapters. Based
on the physical/chemical properties of the PMN substance (as described
in the New Chemical Program's PBT category at 64 FR 60194; November 4,
1999 (FRL-6097-7)) and test data on structurally similar substances,
the PMN substance is a potentially 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
1,000. Based on comparison to analogous chemical substances and
information provided in the SDS, EPA has identified concerns for eye
irritation. Based on comparison to analogous chemical substances, EPA
has also identified concerns for systemic effects and carcinogenicity.
Based on comparison to analogous unhindered anilines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
0.0009 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 in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States; 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
[[Page 49028]]
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, eye
irritation, carcinogenicity, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
fate, 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-23-181 (40 CFR 721.12138)
Chemical name: Alkanedioic acid, polymer with mixed alkanediol,
polyalkyl glycol, carbomonocycle carbomonocycle, alkane carbopolycycle
diisocyanate (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: November 19, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an adhesive. Based on comparison to
analogous diisocyanates, EPA has identified concerns for acute toxicity
(inhalation), skin irritation, eye irritation, respiratory irritation,
skin sensitization, respiratory sensitization, 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:
Manufacture, processing, or use of the PMN substance only
in a manner that does not generate vapor, mist, dust, or aerosol
containing 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, skin irritation, eye irritation, pulmonary effects, 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-24-18 (40 CFR 721.12139)
Chemical name: 2-Propenoic acid, 2-methyl-, butyl ester, polymer
with 2-dodecylhexadecyl 2-methyl-2-propenoate, 2-oxepanone homopolymer,
2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-
tetradecyloctadecyl 2-methyl-2-propenoate.
CASRN: 2854367-08-9.
Effective date of TSCA Order: November 18, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for lubricating oil. Based on
comparison to analogous chemical substances, EPA has identified
concerns for lung effects (lung overload) and 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 human health. To protect against these risks, the
Order requires:
Manufacture, processing, or use of the PMN substance only
in a liquid formulation;
Use of the PMN substance only as an additive for
lubricating oil;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation and pulmonary effects testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-24-36 (40 CFR 721.12140)
Chemical name: Poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy-
(generic).
Accession No.: 303050.
Effective date of TSCA Order: October 17, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an intermediate. Based on test data for a
metabolite, EPA has identified concerns for systemic and reproductive
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:
Processing for use and use of the PMN substance only as an
intermediate;
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
reproductive/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-24-67 (40 CFR 721.12141)
Chemical name: Methanethioic acid, 1,1'-tetrathiobis-, O1,O1'-
bis(1-methylethyl) ester.
CASRN: 69303-50-0.
[[Page 49029]]
Effective date of TSCA Order: November 26, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
rubber accelerator. Based on submitted test data on the PMN substance,
EPA has identified concerns for acute toxicity and skin irritation.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for acute toxicity, skin irritation, skin
sensitization, and systemic effects. Based on comparison to analogous
neutral organics, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 330 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 use of the PMN substance in a spray application;
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, in surface water concentrations that
exceed 169 ppb;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; 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
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-24-69 (40 CFR 721.12142)
Chemical name: Oxa-thiaspiro alkane, oxide (generic).
CASRN or Accession No.: Not available.
Effective date of TSCA Order: December 16, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
additive for use in battery electrolyte formulations. Based on
submitted test data on the PMN substance, EPA has identified concerns
for acute toxicity and respiratory tract irritation. Based on
alkylation potential, substructure, and comparison to analogous
chemical substances, EPA has also identified concerns for genetic
toxicity 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;
Manufacture, processing, and use of the PMN substance only
in an enclosed process;
No processing for use or use of the PMN substance in a
consumer product;
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, into waters of the United States; 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 genetic
toxicity, carcinogenicity, and pulmonary effects testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-100 (40 CFR 721.12143) and P-24-101 (40 CFR 721.12144)
Chemical names: Sulfonyl carbamate of propoxylated alkyl alcohol
(generic) (P-24-100) and Sulfonyl carbamate of ethoxy/propoxylated
alkyl alcohol ethoxy (generic) (P-24-101).
CASRNs or Accession Nos.: Not available.
Effective date of TSCA Order: November 4, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as wetting agents. Based on the structure of
the PMN substances, EPA has identified concerns for lung effects
(surfactancy). Based on comparison to analogous chemical substances and
test data on a feedstock residual of P-24-100, EPA has also identified
concerns for skin, eye, and respiratory tract irritation, systemic
effects, developmental and reproductive effects, acute toxicity, and
neurotoxicity. Based on comparison to analogous carbamate esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 41 ppb (P-24-100) and 1,000 ppb (P-24-101). The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
No processing for use or use of the PMN substances in a
consumer product;
No manufacture, processing, or use of the PMN substances
in any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substances;
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, resulting in surface water
concentrations that exceed 41 ppb in aggregate; 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
[[Page 49030]]
toxicity, eye irritation, pulmonary effects, reproductive/developmental
toxicity, skin irritation, specific target organ 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-24-160 (40 CFR 721.12145)
Chemical name: Iodonium, bis(dialkyl carbomonocycle) salt with
alkyl carbomonocycle hetero-acid (generic).
Accession No.: 303107
Effective date of TSCA Order: November 26, 2024.
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 4, 1999 (FRL-6097-7)) and test data on
structurally similar substances, the PMN substance is a potentially PBT
chemical. EPA estimates that the PMN substance will persist in the
environment for more than six months and has unknown bioaccumulation
potential. EPA estimates that the PMN substance 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 identified concerns
for skin irritation, genetic toxicity, and systemic effects. Based on
the photoreactivity of the PMN substance, EPA has also identified
concerns for photosensitization. Due to a lack of scientific data/
information, EPA is unable to characterize the environmental hazards of
the PMN substance. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No processing of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substance only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, 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-24-190 (40 CFR 721.12146)
Chemical name: Aromatic sulfonium tricyclo salt with alkyl
carbomonocycle hetero-acid (generic).
Accession No.: 303049.
Effective date of TSCA Order: November 26, 2024.
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 4, 1999 (FRL-6097-7)) and test data on
structurally similar substances, the PMN substance is a potentially PBT
chemical. EPA estimates that the PMN substance anion will persist in
the environment for more than six months and has unknown
bioaccumulation potential. EPA also estimates that the PMN substance
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 and respiratory tract, eye corrosion, neurological effects,
and systemic effects for the sulfonium cation of the PMN substance.
Based on the photoreactivity of the PMN substance, EPA has also
identified concerns for photosensitization. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
genetic 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 or
the environment. To protect against these risks, the Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No processing of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substance only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, 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
[[Page 49031]]
II testing outlined in the Testing section of the Order.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action proposes to establish SNURs for new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866 (58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because a significant new use rule for a new chemical under TSCA
section 5 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
EPA always welcomes your feedback on the burden estimates. When
submitting comments on these proposed SNURs, include comments about the
accuracy of the burden estimate, and any suggested methods for
improving the collection instruments or instruction or minimizing
respondent burden, including through the use of automated collection
techniques.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in
FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction
of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the
[[Page 49032]]
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. 721.12112 through 721.12146 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.12112 Alkane diglycidyl ether, polymer with alkyl-
cycloalkane diamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane
diglycidyl ether, polymer with alkyl-cycloalkane diamines (PMN P-20-
138) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 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, serious eye damage, skin corrosion, 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(f) and (o). It is a significant new use to
use the substance in any manner that is a spray application.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12113 Benzenesulfonic acid, polyalkyl derivs., calcium salts
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonic acid, polyalkyl derivs., calcium salts (PMN P-21-101)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12114 2-Propanamine, 1,1'-[(1-
methylethylidene)bis(oxy)]bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanamine,
1,1'-[(1-methylethylidene)bis(oxy)]bis- (PMN P-22-68; CASRN 2267262-12-
2) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators
[[Page 49033]]
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 50, or 1,000 if
spray applied.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, respiratory
sensitization, skin sensitization, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o).
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste steams containing the substance, other than by
hazardous waste incineration.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=60.
(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. 721.12115 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-95; Accession No. 302897) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant new use to process for use or use the substance in consumer
products at a concentration of 3% or greater by weight in formulation.
It is a significant new use to use the substance for commercial or
industrial use at greater than the confidential percentage by weight in
formulation listed in the Order. It is a significant new use to use the
substance in spray applications unless contained in an enclosed
process, other than for the confidential use listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12116 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-96) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant
[[Page 49034]]
new use to process for use or use the substance in consumer products at
a concentration of 3% or greater by weight in formulation. It is a
significant new use to use the substance for commercial or industrial
use at greater than the confidential percentage by weight in
formulation listed in the Order. It is a significant new use to use the
substance in spray applications unless contained in an enclosed
process, other than for the confidential use listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12117 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-97) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant new use to process for use or use the substance in consumer
products at a concentration of 3% or greater by weight in formulation.
It is a significant new use to use the substance for commercial or
industrial use at greater than the confidential percentage by weight in
formulation listed in the Order. It is a significant new use to use the
substance in spray applications unless contained in an enclosed
process, other than for the confidential use listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12118 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-98) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant new use to process for use or use the substance in consumer
products at a concentration of 3% or greater by weight in formulation.
It is a significant
[[Page 49035]]
new use to use the substance for commercial or industrial use at
greater than the confidential percentage by weight in formulation
listed in the Order. It is a significant new use to use the substance
in spray applications unless contained in an enclosed process, other
than for the confidential use listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12119 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-99) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant new use to process for use or use the substance in consumer
products at a concentration of 3% or greater by weight in formulation.
It is a significant new use to use the substance for commercial or
industrial use at greater than the confidential percentage by weight in
formulation listed in the Order. It is a significant new use to use the
substance in spray applications unless contained in an enclosed
process, other than for the confidential use listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12120 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-100) 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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m\3\
in aggregate as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), 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. It is a
significant new use to process for use or use the substance in consumer
products at a concentration of 3% or greater by weight in formulation.
It is a significant new use to use the substance for commercial or
industrial use at greater than the confidential percentage by
[[Page 49036]]
weight in formulation listed in the Order. It is a significant new use
to use the substance in spray applications unless contained in an
enclosed process, other than for the confidential use listed in the
Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed
550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99,
and P-22-100. For purposes of 721.91(a)(7), the control technology is
primary and secondary wastewater treatment as defined in 40 CFR part
133 and the percentage removal of the substance resulting from use of
the specified control technology is 90%.
(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. 721.12121 Carbopolycycle octa-alkene, alkenylaryloxy- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbopolycycle octa-alkene, alkenylaryloxy- (PMN P-22-116; Accession
No. 303094) 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 or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, respiratory sensitization,
skin sensitization, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture, process, or use the substance without capturing all
airborne releases of the substance from manufacture, processing, or use
and either landfill, incinerate, or route through a HEPA filtration
system with a minimum control efficiency of 90%.
(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. 721.12122 Acetamide, N-[3-[alkyl(carbomonocyclic)
substituted]carbomonocycle]-, coupled with diazotized 2-substituted-3-
halo-5-nitrobenzonitrile (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acetamide, N-[3-[alkyl(carbomonocyclic) substituted]carbomonocycle]-,
coupled with diazotized 2-substituted-3-halo-5-nitrobenzonitrile (PMN
P-22-143) 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, genetic 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), (o), and (t). It is a significant new
use to process or use the substance in any manner that results in
inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2. For purposes of
721.91(a)(7), the control technology is primary and secondary
wastewater treatment as defined in 40 CFR part 133 and the percentage
removal of the substance resulting from use of the specified control
technology is 90%.
(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. 721.12123 Amides, alkyl, N-[3-(dimethylamino)propyl] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amides,
alkyl, N-[3-(dimethylamino)propyl] (PMN P-22-168) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, and
[[Page 49037]]
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (v)(1), (v)(2), (v)(4), (w)(1),
(w)(2), (w)(4), (x)(1), (x)(2), and (x)(4). It is a significant new use
to manufacture, process, or use the substance in any manner that
results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12124 Phosphoric acid, dialkyl ester, transition metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphoric acid, dialkyl ester, transition metal salt (PMN P-22-186) 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: eye
irritation, skin 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(y)(1) and (2). It is a significant new use
to manufacture or process the substance in a manner that generates a
dust, vapor, mist, or aerosol containing the substance. It is a
significant new use to process for use or use the substance in a
consumer product unless the concentration of the substance does not
exceed the confidential concentration by weight listed in the Order in
the consumer product.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=32.
(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. 721.12125 2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol, 1,3-
bis[(3-methyl-2-buten-1-yl)oxy]- (PMN P-23-16; CASRN 2337348-25-9) 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) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process for use or use the substance in a
consumer product unless the concentration of the substance is less than
1% by weight in the consumer product. It is a significant new use to
process for use or use the substance in an industrial or commercial
product unless the concentration of the substance is less than or equal
to 2% by weight in the industrial or commercial product.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=230.
(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. 721.12126 Heteromonocyclic, dialkyl amide, substituted alkyl
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocyclic, dialkyl amide, substituted alkyl salt (PMN P-23-47)
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), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive
[[Page 49038]]
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1600.
(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. 721.12127 Oxirane, 2-methyl-, polymer with 2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane, monoether with .alpha.-
butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with 2-[[3-(triethoxysilyl)propoxy]methyl]oxirane, monoether
with .alpha.-butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)] (PMN
P-23-87; CASRN 1973415-03-0) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance when completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through(d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process for use or use the substance in a
consumer product unless the concentration of the substance is less than
3% (by weight) in the consumer product. It is a significant new use to
use the substance in a commercial or industrial product unless the
concentration of the substance in the product does not exceed the
confidential percentage (by weight) listed in the Order. It is a
significant new use to spray apply the substance unless done in an
enclosed process.
(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. 721.12128 Polysaccharide lyase (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polysaccharide lyase (PMN P-23-127) 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), (g)(3))iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: respiratory
sensitization. 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(v)(1), (v)(2), (v)(4), (w)(1), (w)(2),
(w)(4), and (x)(1), (x)(2), and (x)(4). It is a significant new use to
process for use or use the substance other than as an ingredient in
laundry detergent that is used for degradation of stains on fabric.
(iii) Release to water. It is a significant new use to release the
substance, or any waste steam containing the substance, into waters of
the United States if the substance is not deactivated before release to
water. To deactivate the substance, hold at a heat of 65 [deg]C or
greater for at least 10 minutes.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12129 Fatty acids reaction products with
polyalkylpolyamines, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids reaction products with polyalkylpolyamines, salts (PMN P-23-130)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance other than in a liquid or
asphalt formulation. It is a significant new use to manufacture,
process, or use the substance in any
[[Page 49039]]
manner that results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12130 Fatty acids reaction products with alcoholamine
reaction by-products, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids reaction products with alcoholamine reaction by-products, salts
(PMN P-23-133) 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
chemical has been reacted or cured to the extent that no release of the
chemical 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
corrosion, eye irritation, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance other than in a liquid or
asphalt formulation. 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)(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. 721.12131 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
hydro-.omega.-[[2-[(1-chloro-9-oxo-9H-thioxanthen-4-yl)oxy]acetyl]oxy]-
, ether with 2,2-bis(hydroxymethyl)-1,3-propanediol (4:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-hydro-.omega.-[[2-[(1-chloro-9-oxo-9H-
thioxanthen-4-yl)oxy]acetyl]oxy]-, ether with 2,2-bis(hydroxymethyl)-
1,3-propanediol (4:1) (PMN P-23-134; CASRN 1003567-83-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: 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(o). It is a significant new use to
manufacture the substance at a molecular weight of 10,000 Daltons or
greater.
(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. 721.12132 L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., calcium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as L-Lysine, N-(3-
carboxy-1-oxopropyl) derivs., calcium salts (PMN P-23-144; CASRN
1917323-93-3) 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 incorporated as part of an ``article''
as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(3)(iii), and (5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=405.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), 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. 721.12133 Dialkyltin fatty acids ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkyltin fatty acids ester (PMN P-23-149) 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
[[Page 49040]]
Sec. 721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that generates a vapor, mist, dust, or aerosol containing the
substance. It is a significant new use to use the substance unless the
concentration of the substance does not exceed 1.0% by weight in
formulation.
(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. 721.12134 Polypropylene glycol allyloxymethyl acrylate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polypropylene glycol allyloxymethyl acrylate (PMN P-23-166) 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: acute
toxicity, skin irritation, skin sensitization, respiratory
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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=10.
(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. 721.12135 Bisalkyldiacid fluorophosphate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bisalkyldiacid fluorophosphate salt (PMN P-23-167; Accession No.
302773) 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 incorporated into an article as defined at 40 CFR
720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (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, skin sensitization,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) 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)(4), (b)(4), and (c)(4), where N=53.
(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. 721.12136 Sulfamide fluorophosphate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfamide fluorophosphate salt (PMN P-23-168; Accession No. 303038) 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
sealed within an article such as a battery.
(2) The significant new uses are:
[[Page 49041]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, serious eye damage, skin sensitization,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) 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. 721.12137 Benzenamine, 4,4'-(9H-fluoren-9-ylidene)bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenamine, 4,4'-
(9H-fluoren-9-ylidene)bis- (PMN P-23-178; CASRN 15499-84-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
completely reacted or cured (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: eye
irritation, 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), (y)(1), and (2). It is a significant
new use to manufacture or process the substance in a manner that
generates a dust, vapor, mist, or aerosol 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. 721.12138 Alkanedioic acid, polymer with mixed alkanediol,
polyalkyl glycol, carbomonocycle carbomonocycle, alkane carbopolycycle
diisocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymer with mixed alkanediol, polyalkyl glycol,
carbomonocycle carbomonocycle, alkane carbopolycycle diisocyanate (PMN
P-23-181) 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, 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), (y)(1), and (y)(2). It is a
significant new use to manufacture or process the substance in a manner
that generates a dust, vapor, mist, or aerosol containing 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. 721.12139 2-Propenoic acid, 2-methyl-, butyl ester, polymer with
2-dodecylhexadecyl 2-methyl-2-propenoate, 2-oxepanone homopolymer, 2-
[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-
tetradecyloctadecyl 2-methyl-2-propenoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, butyl ester, polymer with 2-dodecylhexadecyl 2-
[[Page 49042]]
methyl-2-propenoate, 2-oxepanone homopolymer, 2-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]ethyl ester and 2-tetradecyloctadecyl 2-methyl-2-
propenoate (PMN P-24-18; CASRN 2854367-08-9) 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), 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(v)(1), (v)(2), (v)(4), (w)(1), (w)(2),
(w)(4), (x)(1), (x)(2), and (x)(4). 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
use the substance other than as an additive for lubricating oil.
(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. 721.12140 Poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy- (PMN P-24-36;
Accession No. 303050) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(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. 721.12141 Methanethioic acid, 1,1'-tetrathiobis-, O1,O1'-bis(1-
methylethyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as methanethioic acid,
1,1'-tetrathiobis-, O1,O1'-bis(1-methylethyl) ester (PMN P-24-67; CASRN
69303-50-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance 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) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, 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 use the
substance in a spray application.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=169.
(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. 721.12142 Oxa-thiaspiro alkane, oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as oxa-
thiaspiro alkane, oxide (PMN P-24-69) 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 incorporated into an article as
defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative
[[Page 49043]]
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, 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(a) through (c), and (o).
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12143 Sulfonyl carbamate of propoxylated alkyl alcohol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonyl carbamate of propoxylated alkyl alcohol (PMN P-24-100) 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 cured resin or 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: acute
toxicity, skin irritation, eye irritation, reproductive toxicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (y)(2). It is a
significant new use to manufacture or process the substance in a manner
that generates a dust, vapor, mist, or aerosol containing the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100
and P-24-101.
(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. 721.12144 Sulfonyl carbamate of ethoxy/propoxylated alkyl
alcohol ethoxy (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonyl carbamate of ethoxy/propoxylated alkyl alcohol ethoxy (PMN P-
24-101) 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 cured resin or 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: acute
toxicity, skin irritation, eye irritation, reproductive toxicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (y)(1), and (y)(2). It is a
significant new use to manufacture or process the substance in a manner
that generates a dust, vapor, mist, or aerosol containing the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100
and P-24-101.
(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. 721.12145 Iodonium, bis(dialkyl carbomonocycle) salt with alkyl
carbomonocycle hetero-acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle
hetero-acid (PMN P-24-160; Accession No. 303107) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures)
[[Page 49044]]
shall be considered and implemented to prevent exposure, where
feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation, 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 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. 721.12146 Aromatic sulfonium tricyclo salt with alkyl
carbomonocycle hetero-acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic sulfonium tricyclo salt with alkyl carbomonocycle hetero-acid
(PMN P-24-190; Accession No. 303049) 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 (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 (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 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2025-19755 Filed 10-31-25; 8:45 am]
BILLING CODE 6560-50-P