[Federal Register Volume 90, Number 64 (Friday, April 4, 2025)]
[Proposed Rules]
[Pages 14743-14771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05480]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0332; FRL-12563-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
4.5e)
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 May 5, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0332 at https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting and visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Ira L. Lyons, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1481; 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-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (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 identified in Unit III. 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:
[[Page 14744]]
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 (e.g., 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 May 5, 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.
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.
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)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov//epa-dockets.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs include PMN substances that are subject to
orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The TSCA orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying TSCA orders, consistent with TSCA section
5(f)(4).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
During review of the PMNs submitted that are the subject to these
proposed SNURs, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. Based on these findings outlined in Unit III.,
TSCA section 5(e) Orders requiring the use of appropriate exposure
controls were
[[Page 14745]]
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.
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
[[Page 14746]]
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 April 4, 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 non-confidential chemical
identities).
Basis for the SNUR (e.g., effective date of and basis for
the TSCA Order).
Potentially useful information.
The regulatory text section of the proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
These proposed SNURs include PMN substances that are subject to
orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying TSCA Orders, consistent with TSCA section
5(f)(4).
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are
as follows:
PMN Number: P-18-360 (40 CFR 721.12077)
Chemical Name: Oxirane, 2-methyl-, polymer with 2,4-diisocyanato-1-
methylbenzene, 2-methyloxirane polymer with oxirane ether with 1,2,3-
propanetriol (3:1), and oxirane, cashew nutshell liq.- and Pr alc. -
blocked.
CASRN: 1227870-90-7.
Effective Date of TSCA Order: May 2, 2024.
Basis for TSCA Order: The PMN states that the use will be as a two-
component adhesive and protective coating for marine and infrastructure
applications. Based on test data for the residual, EPA has identified
concerns for skin sensitization, and skin, eye, and respiratory tract
irritation for the feedstock residual. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No use of the PMN substance other than as a two component
adhesives and protective coating for marine and infrastructure
applications;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; 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, skin irritation, and eye irritation 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.
PMN Number: P-20-87 (40 CFR 721.12078)
Chemical Name: Alcohols, C8-10- iso-, C9-rich, ethoxylated.
CASRN: 2368929-19-3.
Effective Date of TSCA Order: March 21, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
component in hard surface cleaners and laundry detergent. Based on a
structural alert and the category of use, EPA has identified concerns
for lung effects (surfactancy) and irritation to the skin,
[[Page 14747]]
eyes, and respiratory tract. Based on comparison to analogous chemical
substances, EPA has also identified concerns for acute toxicity
(mortality), skin and eye irritation, systemic effects, and
reproductive/developmental effects. Based on comparison to analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 142 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 of the PMN substance to a concentration of
3% or greater in formulation for use in a consumer product;
No use of the PMN substance other than as a surfactant in
hard surface cleaners and laundry detergents;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 142 ppb;
Use of a NIOSH-certified gas/vapor 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
specific target organ toxicity, pulmonary effects, reproductive
toxicity, developmental toxicity, skin irritation, eye damage, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-21-198 (40 CFR 721.12079)
Chemical Name: Reaction product of polyester with alpha.-
hydro-.omega.-hydroxypoly (oxy-1,4- butanediyl) and 1,1'-
methylenebis[isocyanatobenzene] (generic).
CASRN: 302217.
Effective Date of TSCA Order: February 23, 2024.
Basis for TSCA Order: The PMN states that the use will be as a hot
melt moisture cure adhesive for the industrial floor and door industry.
Based on comparison to analogous chemical substances for the residual,
EPA has identified skin and respiratory sensitization, skin, eye, and
respiratory tract irritation, acute toxicity, and pulmonary effects for
the residual. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
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 skin
sensitization, skin irritation, eye damage, 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.
PMN Number: P-21-205 (40 CFR 721.12080)
Chemical Name: Benzene, [2-[(2-methyl-1-undecen-1-yl) oxy]ethyl]-.
CASRN: 2489743-82-8.
Effective Date of TSCA Order: February 29, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive in household consumer
products. Based on submitted test data on the PMN substance, EPA has
identified concerns for skin sensitization, systemic, and developmental
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
No processing for use or use of the PMN substance in
consumer products where the concentration of the PMN substance exceeds
1% by weight;
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 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.
PMN Number: P-21-213 (40 CFR 721.12081)
Chemical Name: Siloxanes and silicones, alkyl methyl, dimethyl
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 26, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a textile finishing agent. Based on the
use of the PMN substance and the structural alert for siloxanes, EPA
has identified concerns for lung waterproofing. Based on the structural
alert for siloxanes and information provided in the SDS, EPA has also
identified concerns for acute toxicity,
[[Page 14748]]
skin irritation, 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:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No processing for use or use of the PMN substance in
consumer product formulations;
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, specific target organ toxicity, pulmonary effects, skin
irritation, and eye damage 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.
PMN Number: P-22-19 (40 CFR 721.12082)
Chemical Name: Protein sodium complexes, polymers with aromatic
acid chloride, ethylene diamine and amino acid (generic).
CASRN: 302206.
Effective Date of TSCA Order: December 12, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a film-forming polymer. Based on
structure, EPA has identified concerns for lung overload. Based on
physical/chemical properties and protein structure of the PMN substance
and a feedstock residual, EPA has also identified concerns for lung
surfactancy, irritation to the skin, eyes, and respiratory tract, and
skin and respiratory sensitization. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to workers;
No processing of the PMN substance for use in a consumer
product where the concentration of a confidential component of the New
Chemical Substance listed in the Order in the consumer product exceeds
0.1% and to the extent that remaining unknown components do not exhibit
sensitizing properties;
No use of the PMN substance in consumer products where the
concentration of the confidential component listed in the Order exceeds
0.1%;
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, skin irritation, 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.
PMN Number: P-22-22 (40 CFR 721.12083)
Chemical Name: Aryl-substituted-heterocyclic-polyamine, reaction
products with polyethylene glycol alkyl-ether, and nitrogen and alkyl-
substituted benzene (generic).
Accession No.: 302046.
Effective Date of TSCA Order: September 28, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a dispersing additive. Based on comparison
to analogous chemical substances and the surfactant-like structure of
the PMN substance, EPA has identified concerns for lung effects. Based
on the surfactant-like structure of the PMN substance, EPA has also
identified concerns for irritation to the skin, eyes, and respiratory
tract. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in 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
irritation, eye damage, 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.
PMN Number: P-22-59 (40 CFR 721.12084)
Chemical Name: Thermomycolin, Malbranchea cinnamomea origin,
expressed in genetically modified Trichoderma reesei.
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: May 16, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
enzyme in laundry and dishwashing detergents. Based on comparison to
analogous chemical substances, EPA has identified concerns for
irritation to the skin, eyes, and respiratory tract, respiratory
sensitization and allergenic effects, and point-of-contact effects in
the Gastrointestinal (GI) tract. Based on comparison to analogous
chemical substances, EPA predicts toxicity to
[[Page 14749]]
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 of the PMN substance other than by import
into the United States (i.e., no domestic manufacture) in a liquid
formulation;
No processing for use or use of the PMN substance in
consumer products unless the concentration of the PMN substance in the
consumer product is less than 0.1% by weight;
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 water during processing unless the
PMN substance is deactivated before releasing to water. To deactivate
the New Chemical Substance, adjust the pH to 2 or below and incubate
for 30 minutes; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin irritation, 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.
PMN Number: P-22-83 (40 CFR 721.12085)
Chemical Name: Oils, sandalwood, santalene synthase-modified
Rhodobacter sphaeroides-fermented, from D-Glucose, oxidized.
CASRN: 2576531-09-2.
Effective Date of TSCA Order: May 8, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a perfume. Based on submitted test data on
the PMN substance and information provided in the SDS, EPA has
identified concerns for skin irritation and skin sensitization. Based
on the hydrocarbon structure of the PMN substance, EPA has also
identified concerns for solvent neurotoxicity. Based on comparison to
analogous chemical substances and components of the PMN substance, EPA
has also identified concerns for acute neurotoxicity, skin irritation,
skin sensitization, and systemic effects. Based on comparison to
analogous vinyl/allyl/propargyl alcohols, 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:
No processing for use or use of the PMN substance in
consumer products where the concentration of the PMN substance exceeds
1% by weight;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 1 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
specific target organ toxicity, neurotoxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-22-89 (40 CFR 721.12086)
Chemical Name: Carboxylic acid substituted carbomonocycles, polymer
with dialkyl-alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl)
oxy]alkyl ester (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: January 2, 2024.
Basis for TSCA Order: The PMN states that the use will be as a UV
cured resin for dry toner printing. Based on comparison to analogous
acrylates/methacrylates, EPA has identified concerns for skin, eye, and
respiratory tract irritation and skin sensitization. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
No processing for use or use of the PMN substance in
consumer products;
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 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.
PMN Number: P-22-90 (40 CFR 721.12087)
Chemical Name: 4,8,11-Dodecatrienal.
CASRN: 1000399-21-2.
Effective Date of TSCA Order: April 5, 2024.
[[Page 14750]]
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a perfume. Based on submitted test data on
the PMN substance, EPA has identified concerns for skin irritation and
skin sensitization. Based on comparison to analogous chemical
substances, EPA has also identified concerns for systemic effects.
Based on submitted test data on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
13 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 of the PMN substance for use in consumer
products only where the concentration of the PMN substance is less than
1% concentration by weight;
Use of the PMN substance only where the concentration of
the PMN substance in the product is less than 1% concentration by
weight;
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, in surface water concentrations that
exceed 13 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
specific target organ toxicity, toxicokinetics, 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.
PMN Number: P-22-91 (40 CFR 721.12088)
Chemical Name: Alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: March 18, 2024.
Basis for TSCA Order: The PMN states that the use will be as a UV
cured resin for dry toner printing. Based on comparison to analogous
acrylates/methacrylates, EPA has identified concerns for skin, eye, and
respiratory tract irritation and skin sensitization. Based on
comparison to analogous acrylates/methacrylates, 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 release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 3 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 eye
irritation, skin irritation, skin sensitization, 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.
PMN Number: P-22-93 (40 CFR 721.12089)
Chemical Name: Alkenoic acid, alkyl-substituted alkyl ester,
polymer with (polyalkylamino)alkyl alkylalkenoate, alkyl-substituted
alkylalkenoate, .alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-1,2-
ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-initiated,
compds. with polyethylene glycol phosphoric acid-based alkyl ether
(generic).
Accession No.: 302499.
Effective Date of TSCA Order: April 11, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive used for pigment
stabilization. Based on comparison to analogous chemical substances,
EPA has identified concerns for lung effects (surfactancy) and eye
irritation. Based on comparison to analogous cationic polymers and the
standard toxicity profile for phosphate, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 18 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. The
requirements of this section do not apply to quantities of the
substance after they have been incorporated into an article. To protect
against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 18 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
[[Page 14751]]
determined that the results of pulmonary effects, eye irritation, 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.
PMN Numbers: P-22-130 (40 CFR 721.12090), P-22-131 (40 CFR 721.12091),
P-22-132 (40 CFR 721.12092), P-22-133 (40 CFR 721.12093), P-22-134 (40
CFR 721.12094), and P-22-135 (40 CFR 721.12095)
Chemical Names: Maltodextrin, octanoate (P-22-130), Maltodextrin,
hexadecanoate (P-22-131), Maltodextrin, decanoate (P-22-132),
Maltodextrin, octadecanoate (P-22-133), Maltodextrin, dodecanoate (P-
22-134), and Maltodextrin, tetradecanoate (P-22-135).
CASRNs: 2736503-99-2 (P-22-130), 1516876-50-8 (P-22-131), 1516876-
47-3 (P-22-132), 1159570-68-9 (P-22-133), 512180-33-5 (P-22-134), and
2736504-00-8 (P-22-135).
Effective Date of TSCA Order: April 9, 2024.
Basis for TSCA Order: The PMNs state that the uses will be as
surface tension reducing agents for use in production enhancement in
oil wells, surfactants for use in the manufacture of industrial
products, consumer, and household products, wetting agents in
agriculture, wetting agents/emulsifiers in personal care products, and
as emulsifiers/surface reduction in household and industrial products.
Based on intended use and structure, EPA has identified concerns for
lung toxicity (surfactant effects). Based on comparison to analogous
chemical substances, EPA has also identified concerns for serious eye
damage for P-22-130, P-22-132, and P-22-134. 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. To protect against these risks, the Order
requires:
Use of a NIOSH-certified particulate respirator with an
APF of at least 1000 where there is a potential for inhalation
exposure;
Manufacture, processing, or use of the PMN substances only
in aqueous dispersions;
No processing for use or use of the PMN substances in
consumer products that are spray applied;
No processing for use or use of the PMN substances in
consumer products if the concentration of the PMN substances is equal
to or exceeds 3% by weight in the consumer product;
No use of the PMN substances as agricultural wetting
agents;
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, eye irritation, and toxicokinetics testing may be
potentially useful to characterize the health effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-22-139 (40 CFR 721.12096)
Chemical Name: Dialkylhydroxylamine (generic).
Accession No.: 302353.
Effective Date of TSCA Order: March 11, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an antioxidant/process stabilizer. Based
on comparison to analogous chemical substances, EPA has identified
concerns for skin sensitization and systemic effects. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
Manufacture of the PMN substance only when using local
exhaust ventilation (LEV) and particulate filters with at least 90%
efficiency to control dust released to air;
The form giving process may be conducted on the PMN
substance only when using LEV and HEPA dust filters with at least 99%
efficiency to control dust released to air during transfer;
The form giving process may be conducted on the PMN
substance only when using an enclosed system with HEPA dust filters
with at least 99% efficiency to control dust released to air during all
processing steps other than transfer;
No use of the PMN substance other than as an antioxidant
process stabilizer;
Use of a NIOSH-certified particulate 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 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.
PMN Number: P-22-154 (40 CFR 721.12097)
Chemical Name: Acetyl, alkyl, alkenoic acid, ethyl ester (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: November 29, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a fragrance ingredient for use in laundry
applications. Based on submitted test data on the PMN substance, EPA
has identified concerns for acute toxicity, skin sensitization,
systemic effects, and developmental effects. Based on comparison to
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 2 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a
[[Page 14752]]
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
consumer products where the concentration of the PMN substance exceeds
1%;
No manufacture or processing of the PMN substance in any
manner that results in 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, 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
pulmonary effects, developmental effects, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-22-155 (40 CFR 721.12098)
Chemical Name: 2-Alkyl-1,2-heteropolycycle-3-one (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 11, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a physical property modifier for
polyurethanes and as a modifier for polyurethane blends. Based on
submitted test data on the PMN substance, EPA has identified concerns
for skin corrosion and portal-of-entry (oral) effects. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for acute toxicity, eye corrosion, skin sensitization, portal-
of-entry (oral and inhalation) effects, and systemic effects. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
Processing or use of the PMN substance only in the form of
a liquid;
Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture) in the form of a liquid;
No processing for use or use of the PMN substance in a
consumer product formulation;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 1 ppb;
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
neurotoxicity, skin irritation/corrosion, eye irritation/corrosion,
skin sensitization, pulmonary effects, specific target organ toxicity,
and aquatic toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-22-157 (40 CFR 721.12099)
Chemical Name: 1,2-Ethanediamine, N1, N2-dimethyl-N1-(1-
methylethyl)-N2-[2-[methyl(1-methylethyl)amino]ethyl]-.
CASRN: 1042950-30-0.
Effective Date of TSCA Order: May 9, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
polyurethane catalyst. Based on submitted test data on the PMN
substance, EPA has identified concerns for acute toxicity, skin
corrosion, and systemic and developmental effects. Based on comparison
to analogous chemical substances, EPA has also identified concerns for
eye and respiratory tract corrosion and skin sensitization. Based on
submitted test data on the PMN substance and comparison to analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 650 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 650 ppb;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 during manufacturing and processing (a respirator with an
APF of at least 50 may be used if a minimum ventilation airflow of
3,500 standard cubic feet per minute is maintained in the work area)
and a respirator with an APF of at least 50 during use where there is a
potential for inhalation exposure;
No processing for use or use of the PMN substance in a
consumer product;
Use of the PMN substance only as a polyurethane catalyst;
No processing for use or use of the PMN substance at a
concentration > 3% by weight;
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
specific target organ toxicity testing may be
[[Page 14753]]
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.
PMN Number: P-22-167 (40 CFR 721.12100)
Chemical Name: 1,2-Cycloalkanedicarboxylic acid, 1,2-bis(2-
oxiranylalkyl) ester, reaction products with unsaturated carboxylic
acid (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: March 29, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in photolithography. Based on comparison to
analogous acrylates/methacrylates, EPA has identified concerns for
skin, eyes, and respiratory irritation and skin and respiratory tract
sensitization. Based on submitted test data on the PMN substance and
comparison to analogous acrylates/methacrylates and esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 460 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;
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 460 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, skin irritation, skin sensitization, 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.
PMN Number: P-22-192 (40 CFR 721.12101)
Chemical Name: Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-
substituted polycarbocyclicalkanesulfonate (1:1) (generic).
CASRN: 302579.
Effective Date of TSCA Order: April 26, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for photolithography.
Based on the physical/chemical properties of the PMN substance (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 1999) and test data on structurally similar substances, the
PMN substance is a potentially persistent, bioaccumulative, and toxic
(PBT) chemical. EPA estimates that the anion, the incineration product,
the cation, and the cation photodegradation product of the PMN
substance will persist in the environment for more than six months,
estimates a bioaccumulation factor for the cation photodegradation
product of the PMN substance of greater than or equal to 1,000, and
estimates an unknown bioaccumulation factor for the cation and anion of
the PMN substance. Based on sulfonium compounds, EPA has identified
concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, eye corrosion, ocular lethality, neurological
effects, and systemic effects for the sulfonium cation of the PMN
substance. Based on the photo reactivity of the PMN substance, EPA has
also identified concerns for photosensitization for the sulfonium
cation of the PMN substance. Based on the reactivity of the PMN
substance, EPA has also identified concerns for irritation to the skin,
eyes, and respiratory tract for the sulfonium cation of the PMN
substance. Based on comparison to analogous chemical substances, EPA
has also identified concerns for mutagenicity for the sulfonium cation
of the PMN substance. Based on comparison to analogous chemical
substances for the perfluoro anion, EPA has also identified concerns
for acute toxicity, skin irritation, eye corrosion, GI tract
irritation, and systemic, reproductive, and developmental effects for
the anion. Based on a potential incineration by-product, EPA has also
identified concerns for local, neurotoxic, and systemic effects. EPA
was unable to estimate the environmental hazard of the PMN substance.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health 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 modification of the processing or use 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.
[[Page 14754]]
PMN Number: P-23-38 (40 CFR 721.12102)
Chemical Name: Formaldehyde, polymer with phenol, carboxyalkyl
ethers, alkali salts, compds. with (dialkylamino)alkanol (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: January 2, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
crosslinker (hardener) for various water dilutable backbone binders to
obtain high chemical resistant protective layers for heat curing metal
application. Based on test data for the cation of the PMN substance,
EPA has identified concerns for acute toxicity, portal-of-entry
(inhalation) effects, skin corrosion, eye corrosion, skin
sensitization, neurotoxicity, systemic effects, and reproductive/
developmental effects for the cation of the PMN substance. Based on
comparison to analogous phenols and to the physical/chemical properties
of the PMN substance, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 120 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
No manufacture, processing, or use of the PMN substance
for commercial use;
No manufacture or processing of the PMN substance in any
manner that results in the generation of a vapor, mist, dust, or
aerosol;
No processing for use or use of the PMN substance as a
consumer product;
Use of the PMN substance only in an enclosed process;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 120 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 acute
toxicity, developmental toxicity, eye irritation/corrosion,
neurotoxicity, pulmonary effects, reproductive toxicity, skin
corrosion, skin sensitization, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-23-42 (40 CFR 721.12103)
Chemical Name: Oxirane, alkyl-, polymer with oxirane, monoethers
with polyethylene glycol alkenyl ether (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 29, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
intermediate to produce polymers. Based on submitted test data on the
PMN substance, EPA has identified concerns for skin corrosion. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for systemic and developmental effects. Based on the structure
of the PMN substance, EPA has also identified concerns for lung
effects. Based on comparison to analogous nonionic surfactants and on
submitted test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 982 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;
Use of the PMN substance only as an intermediate for use
in producing polymers;
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
specific target organ toxicity, developmental toxicity, pulmonary
effects, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-23-43 (40 CFR 721.12104)
Chemical Name: Oxirane, alkyl-, polymer with oxirane, sulfate,
ethers with polyethylene glycol alkenyl ether, salt (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: April 29, 2024.
Basis for TSCA Order: The PMN states that the use will be as an
intermediate to produce polymers. Based on structure and submitted test
data on the PMN substance, EPA has identified concerns for lung effects
(surfactancy). Based on submitted test data on the PMN substance, EPA
has also identified concerns for skin irritation. Based on comparison
to analogous chemical substances, EPA has also identified concerns for
clinical signs and portal-of-entry (oral) effects. Based on comparison
to analogous anionic surfactants and on comparison to analogous
chemical substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 1,000 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;
[[Page 14755]]
Use of the PMN substance only as an intermediate for use
in producing polymers;
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
specific target organ toxicity, pulmonary effects, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-23-61 (40 CFR 721.12105)
Chemical Name: Alkanoic acid, substituted, polymer with substituted
alkanoic acid, from fermentation of fermentable sugars (generic).
CASRN: 302397.
Effective Date of TSCA Order: March 22, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a plastic resin. Based on comparison to
analogous chemical substances, EPA has identified concerns for skin
irritation, eye irritation, and skin sensitization. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Use of 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, skin irritation, and skin sensitization testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-23-74 (40 CFR 721.12106)
Chemical Name: 2-Propenoic acid, 2-methyl-, C13-15-branched and
linear alkyl esters.
CASRN: 90552-04-8.
Effective Date of TSCA Order: April 8, 2024.
Basis for TSCA Order: The PMN states that the use will be as a
monomer used in the production of polymers. Based on submitted test
data on the PMN substance and comparison to analogous methacrylates,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 0.13 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, into waters of the United States; and
Establishment of a hazard communication program, including
precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity 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.
PMN Number: P-23-126 (40 CFR 721.12107)
Chemical Name: Alken-1-ol (generic).
CASRN: 302580.
Effective Date of TSCA Order: May 21, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical raw material used in pheromone
production. Based on submitted test data on the PMN substance, EPA has
identified concerns for irritation/corrosion to skin, respiratory
tract, and eyes. Based on submitted test data on the PMN substance and
comparison to analogous neutral organics, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 238 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a
consumer product;
Use of a NIOSH-certified gas/vapor respirator with an APF
of at least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure;
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 eye
irritation, pulmonary effects, 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
[[Page 14756]]
Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Numbers: P-23-176 (40 CFR 721.12108) and P-23-179 (40 CFR
721.12109)
Chemical Names: Sulfonium, bis (dihalo carbomonocycle)
carbomonocycle-, salt with dihalo-sulfoalkyl trisubstituted benzoate
(generic) (P-23-176) and Sulfonium,
bis(dihalocarbomonocycle)carbomonocycle-, salt with substituted-
dihalobenzoate (generic) (P-23-179).
CASRN: 302386 (P-23-176), not available (P-23-179).
Effective Date of TSCA Order: March 6, 2024.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as ingredients used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substances (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and test data on
structurally similar substances, the PMN substance are potentially
persistent, bioaccumulative, and toxic (PBT) chemicals EPA estimates
that the PMN substances will persist in the environment for more than
six months and estimates a bioaccumulation factor of greater than or
equal to 1,000. Based on sulfonium compounds, EPA has identified
concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, eye corrosion, neurological effects, and systemic
effects for the sulfonium cation of the PMN substances. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for genetic toxicity. Based on the photo reactivity of the PMN
substances, EPA has also identified concerns for photosensitization.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for systemic and developmental effects for the
anion component of the PMN substances. Based on a potential
incineration product, EPA has also identified concerns for local and
systemic effects via inhalation exposure. Based on OECD Toolbox
results, EPA also identified concerns for skin sensitization (P-23-176)
for the anion. Based on DEREK prediction for the anion, EPA has also
identified systemic (thyroid) toxicity (P-23-179) for the anion. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
No manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA the results of
certain testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No processing of the PMN substances in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential uses
listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, unless in
sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
PMN Number: P-24-42 (40 CFR 721.12110)
Chemical Name: Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-,
salt with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle)
carbopolycycle (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: March 6, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and test data on
structurally similar substances, the PMN substance is a potentially
persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates
that the anion, the cation, the incineration product, and the cation
photodegradation product of the PMN substance will persist in the
environment for more than six months. EPA estimates that the anion and
the cation have unknown bioaccumulation potential, that the
incineration product may accumulate in organisms by mechanisms other
than lipophilic partitioning, and that the cation photodegradation
product has a bioaccumulation factor of greater than or equal to 1,000.
Based on 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 comparison to analogous chemical
substances, EPA has also identified concerns for genetic toxicity for
the sulfonium cation of the PMN substance. Based on the photo
reactivity of the PMN substance, EPA has also identified concerns for
photosensitization for the sulfonium cation of the PMN substance. Based
on OECD QSAR Toolbox results, EPA has also identified concerns for skin
and respiratory tract sensitization for the anion. Based on an
incineration product, EPA has identified concerns for local,
neurological, developmental, and systemic effects via inhalation
exposure. 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;
[[Page 14757]]
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.
PMN Number: P-24-97 (40 CFR 721.12111)
Chemical Name: Sulfonium, tris(4-fluorophenyl)-,
(substitutedphenoxy)alkyl substitutedbenzoate (1:1) (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: May 13, 2024.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for contained use for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substance (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 1999) and
test data on structurally similar substances, the PMN substance is a
potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA
estimates that the anion, cation, incineration product, and cation
photodegradation product of the PMN substance will persist in the
environment for more than six months. EPA estimates that the anion and
the cation have unknown bioaccumulation potential, that the
incineration product may accumulate in organisms by mechanisms other
than lipophilic partitioning, and that the cation photodegradation
product has a bioaccumulation factor of greater than or equal to 1,000.
Based on sulfonium compounds, EPA has identified concerns for acute
toxicity, irritation to the skin and respiratory tract, eye corrosion,
genetic toxicity, and neurological and systemic effects for the
sulfonium cation of the PMN substance. Based on the photoreactivity of
the PMN substance, EPA has also identified concerns for
photosensitization for the sulfonium cation of the PMN substance. Based
on OECD Toolbox results, EPA has also identified concerns for skin
sensitization for the anion. 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.
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. 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. Send any
comments about the accuracy of the burden estimate, and any suggested
methods for improving the collection instruments or instruction or
minimizing respondent burden, including using automated collection
techniques.
C. 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
[[Page 14758]]
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, 13 in
FY2021, 11 in FY2022, and 15 in FY2023, 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.
D. 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.
E. 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.
F. 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.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the intended uses to identify potential risks and
take appropriate actions before the activities commence.
H. 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.
I. 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: March 26, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, 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. 721.12077 through 721.12111 to Subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.12077 Oxirane, 2-methyl-, polymer with 2,4-diisocyanato-1-
methylbenzene, 2-methyloxirane polymer with oxirane ether with
1,2,3-propanetriol (3:1), and oxirane, cashew nutshell liq.- and Pr
alc. -blocked.
721.12078 Alcohols, C8-10-iso-, C9-rich, ethoxylated.
721.12079 Reaction product of polyester with alpha.-hydro-.omega.-
hydroxypoly (oxy-1,4- butanediyl) and 1,1'-
methylenebis[isocyanatobenzene] (generic).
721.12080 Benzene, [2-[(2-methyl-1-undecen-1-yl) oxy]ethyl]-.
721.12081 Siloxanes and Silicones, alkyl methyl, dimethyl (generic).
721.12082 Protein sodium complexes, polymers with aromatic acid
chloride, ethylene diamine and amino acid (generic).
721.12083 Aryl-substituted-heterocyclic-polyamine, reaction products
with polyethylene glycol alkyl-ether, and nitrogen and alkyl-
substituted benzene (generic).
721.12084 Thermomycolin, Malbranchea cinnamomea origin, expressed in
genetically modified Trichoderma reesei.
721.12085 Oils, sandalwood, santalene synthase-modified Rhodobacter
sphaeroides-fermented, from D-Glucose, oxidized.
721.12086 Carboxylic acid substituted carbomonocycles, polymer with
dialkyl-
[[Page 14759]]
alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl) oxy]alkyl
ester (generic).
721.12087 4,8,11-Dodecatrienal.
721.12088 Alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked
(generic).
721.12089 Alkenoic acid, alkyl-substituted alkyl ester, polymer with
(polyalkylamino)alkyl alkylalkenoate, alkyl-substituted
alkylalkenoate, .alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-
1,2-ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-
initiated, compds. with polyethylene glycol phosphoric acid-based
alkyl ether (generic).
721.12090 Maltodextrin, octanoate.
721.12091 Maltodextrin, hexadecanoate.
721.12092 Maltodextrin, decanoate.
721.12093 Maltodextrin, octadecanoate.
721.12094 Maltodextrin, dodecanoate.
721.12095 Maltodextrin, tetradecanoate.
721.12096 Dialkylhydroxylamine (generic).
721.12097 Acetyl, alkyl, alkenoic acid, ethyl ester (generic).
721.12098 2-Alkyl-1,2-heteropolycycle-3-one (generic).
721.12099 1,2-Ethanediamine, N1, N2-dimethyl-N1-(1-methylethyl)-N2-
[2-[methyl(1-methylethyl)amino]ethyl]-.
721.12100 1,2-Cycloalkanedicarboxylic acid, 1,2-bis(2-oxiranylalkyl)
ester, reaction products with unsaturated carboxylic acid (generic).
721.12101 Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-
substituted polycarbocyclicalkanesulfonate (1:1) (generic).
721.12102 Formaldehyde, polymer with phenol, carboxyalkyl ethers,
alkali salts, compds. with (dialkylamino)alkanol (generic).
721.12103 Oxirane, alkyl-, polymer with oxirane, monoethers with
polyethylene glycol alkenyl ether (generic).
721.12104 Oxirane, alkyl-, polymer with oxirane, sulfate, ethers
with polyethylene glycol alkenyl ether, salt (generic).
721.12105 Alkanoic acid, substituted, polymer with substituted
Alkanoic acid, from fermentation of fermentable sugars (generic).
721.12106 2-Propenoic acid, 2-methyl-, C13-15-branched and linear
alkyl esters.
721.12107 Alken-1-ol (generic).
721.12108 Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-,
salt with dihalo-sulfoalkyl trisubstituted benzoate (generic).
721.12109 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt
with substituted-dihalobenzoate (generic).
721.12110 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt
with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle)
carbopolycycle (generic).
721.12111 Sulfonium, tris(4-fluorophenyl)-,
(substitutedphenoxy)alkyl substitutedbenzoate (1:1) (generic).
* * * * *
Sec. 721.12077 Oxirane, 2-methyl-, polymer with 2,4-diisocyanato-1-
methylbenzene, 2-methyloxirane polymer with oxirane ether with 1,2,3-
propanetriol (3:1), and oxirane, cashew nutshell liq.- and Pr alc. -
blocked.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with 2,4-diisocyanato-1-methylbenzene, 2-methyloxirane polymer
with oxirane ether with 1,2,3-propanetriol (3:1), and oxirane, cashew
nutshell liq.- and Pr alc. -blocked (PMN P-18-360; CASRN 1227870-90-7)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the 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), (3) through (5), 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), and (g)(1) and (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 use the
substance other than as a two component adhesives and protective
coating for marine and infrastructure applications.
(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. 721.12078 Alcohols, C8-10-iso-, C9-rich, ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alcohols, C8-10-
iso-, C9-rich, ethoxylated (PMN P-20-87; CASRN 2368929-19-3) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3)(iii) and (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, 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 process the substance to a concentration of 3%
or greater in formulation for use in a consumer product. It is a
significant new use to use the substance other than as a surfactant in
hard surface cleaners and laundry detergents.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=142.
(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
[[Page 14760]]
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. 721.12079 Reaction product of polyester with alpha.-
hydro-.omega.-hydroxypoly (oxy-1,4- butanediyl) and 1,1'-
methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of polyester with alpha.-hydro-.omega.-hydroxypoly
(oxy-1,4- butanediyl) and 1,1'-methylenebis[isocyanatobenzene] (PMN P-
21-198; Accession No. 302217) 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), (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), and (g)(1) and (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). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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. 721.12080 Benzene, [2-[(2-methyl-1-undecen-1-yl) oxy]ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, [2-[(2-
methyl-1-undecen-1-yl) oxy]ethyl]- (PMN P-21-205; CASRN 2489743-82-8)
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), (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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, specific
target organ toxicity, and reproductive toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance for use in consumer
products where the concentration of the substance exceeds 1% by weight.
It is a significant new use to use the substance in consumer products
where the concentration of the substance exceeds 1% by weight.
(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. 721.12081 Siloxanes and Silicones, alkyl methyl, dimethyl
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, alkyl methyl, dimethyl (PMN P-21-213) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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, eye irritation, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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. 721.12082 Protein sodium complexes, polymers with aromatic acid
chloride, ethylene diamine and amino acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as protein
sodium complexes, polymers with aromatic acid
[[Page 14761]]
chloride, ethylene diamine and amino acid (PMN P-22-19; Accession No.
302206) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to workers. It is a
significant new use to process the substance for use in consumer
products where the concentration of the confidential component of the
substance listed in the Order in the consumer product exceeds 0.1%. It
is a significant new use to use the substance in consumer products
where the concentration of the confidential component listed in the
Order exceeds 0.1%.
(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) 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. 721.12083 Aryl-substituted-heterocyclic-polyamine, reaction
products with polyethylene glycol alkyl-ether, and nitrogen and alkyl-
substituted benzene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as aryl-
substituted-heterocyclic-polyamine, reaction products with polyethylene
glycol alkyl-ether, and nitrogen and alkyl-substituted benzene (PMN P-
22-22; Accession No. 302046) 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 completely reacted or
cured ink.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, 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.
(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. 721.12084 Thermomycolin, Malbranchea cinnamomea origin,
expressed in genetically modified Trichoderma reesei.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as thermomycolin,
Malbranchea cinnamomea origin, expressed in genetically modified
Trichoderma reesei (PMN P-22-59) 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 in a formulation at a concentration of
0.1% or less.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, 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. It is a
significant new use to manufacture the substance other than by import
into the United States (i.e., no domestic manufacture) in a liquid
formulation. It is a significant new use to process for use or use the
substance in consumer products unless the concentration of the
substance in the consumer products is less than 0.1% by weight.
(iv) Release to water. It is a significant new use to release the
substance, or any waste stream containing the substance, into water
during processing unless the substance is deactivated before releasing
to water. To deactivate the New Chemical Substance, adjust the pH to 2
or below and incubate for 30 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 14762]]
Sec. 721.12085 Oils, sandalwood, santalene synthase-modified
Rhodobacter sphaeroides-fermented, from D-Glucose, oxidized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, sandalwood,
santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-
Glucose, oxidized (PMN P-22-83; CASRN 2576531-09-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), 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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: 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. It is a
significant new use to process for use or use the substance in consumer
products where the concentration of the substance exceeds 1% by weight.
(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. 721.12086 Carboxylic acid substituted carbomonocycles, polymer
with dialkyl-alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl)
oxy]alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carboxylic acid substituted carbomonocycles, polymer with dialkyl-
alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl) oxy]alkyl ester
(PMN P-22-89) 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) and (3) through (5), 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), and (g)(1) and (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).
(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. 721.12087 4,8,11-Dodecatrienal.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4,8,11-
dodecatrienal (PMN P-22-90; CASRN 1000399-21-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), 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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: 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(k). It is a significant new use to process
the substance for use in a consumer product unless the concentration of
the substance is less than 1% concentration by weight. It is a
significant new use to use the substance unless the concentration of
the substance in the product is less than 1% concentration by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=13.
(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. 721.12088 Alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 14763]]
(1) The chemical substance identified generically as alkanol, polymer
with isocyanato-(isocyanatoalkyl)-trialkylcarbomonocycle, alkylene
glycol monoacrylate-blocked (PMN P-22-91) 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), (3) through (5), 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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12089 Alkenoic acid, alkyl-substituted alkyl ester, polymer
with (polyalkylamino)alkyl alkylalkenoate, alkyl-substituted
alkylalkenoate, .alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-1,2-
ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-initiated,
compds. with polyethylene glycol phosphoric acid-based alkyl ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkyl-substituted alkyl ester, polymer with
(polyalkylamino)alkyl alkylalkenoate, alkyl-substituted alkylalkenoate,
.alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-1,2-ethanediyl),
[(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-initiated, compds. with
polyethylene glycol phosphoric acid-based alkyl ether (PMN P-22-93;
Accession No. 302499) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3)(iii) and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: eye irritation 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=18.
(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. 721.12090 Maltodextrin, octanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
octanoate (PMN P-22-130; CASRN 2736503-99-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 14764]]
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. 721.12091 Maltodextrin, hexadecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
hexadecanoate (PMN P-22-131; CASRN 1516876-50-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(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. 721.12092 Maltodextrin, decanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
decanoate (PMN P-22-132; CASRN 1516876-47-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(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. 721.12093 Maltodextrin, octadecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
octadecanoate (PMN P-22-133; CASRN 1159570-68-9) 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) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration
[[Page 14765]]
of the substance is equal to or exceeds 3% by weight. It is a
significant new use to use the substance as an agricultural wetting
agent.
(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. 721.12094 Maltodextrin, dodecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
dodecanoate (PMN P-22-134; CASRN 512180-33-5) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(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. 721.12095 Maltodextrin, tetradecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
tetradecanoate (PMN P-22-135; CASRN 2736504-00-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(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. 721.12096 Dialkylhydroxylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
Dialkylhydroxylamine (PMN P-22-139; Accession No. 302353) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance without using local
exhaust ventilation
[[Page 14766]]
(LEV) and particulate filters with at least 90% efficiency to control
dust released to air. It is a significant new use to conduct the form
giving process on the substance without using LEV and HEPA dust filters
with at least 99% efficiency to control dust released to air during
transfer. It is a significant new use to conduct the form giving
process on the substance without using an enclosed system with HEPA
dust filters with at least 99% efficiency to control dust released to
air during all processing steps other than transfer. It is a
significant new use to use the substance other than as an antioxidant
process stabilizer.
(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. 721.12097 Acetyl, alkyl, alkenoic acid, ethyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acetyl,
alkyl, alkenoic acid, ethyl ester (PMN P-22-154) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), 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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that results in inhalation exposure. It is a significant new use
to process for use or use the substance in consumer products where the
concentration of the substance exceeds 1%.
(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. 721.12098 2-Alkyl-1,2-heteropolycycle-3-one (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
alkyl-1,2-heteropolycycle-3-one (PMN P-22-155) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been incorporated into
an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), 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), and (g)(1), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, serious eye damage, skin sensitization, and specific target
organ toxicity. For purposes Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (o), (v)(1), (2) and (4), (w)(1), (2)
and (4), and (x)(1), (2) and (4).
(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. 721.12099 1,2-Ethanediamine, N1, N2-dimethyl-N1-(1-methylethyl)-
N2-[2-[methyl(1-methylethyl)amino]ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediamine,
N1, N2-dimethyl-N1-(1-methylethyl)-N2-[2-[methyl(1-
methylethyl)amino]ethyl]- (PMN P-22-157; CASRN 1042950-30-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), 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 during manufacturing
and processing (a respirator with an APF of at least 50 may be used if
a minimum ventilation airflow of 3,500 standard cubic feet per minute
is maintained in the work area), and a respirator with an APF of at
least 50 during use.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, serious eye damage,
[[Page 14767]]
reproductive toxicity, specific target organ toxicity, and skin
sensitization. For the purposes of Sec. 721.72(g)(3), this substance
may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance other than as a polyurethane catalyst. It is a significant
new use to process for use or use the substance at a concentration >3%
by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=650.
(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. 721.12100 1,2-Cycloalkanedicarboxylic acid, 1,2-bis(2-
oxiranylalkyl) ester, reaction products with unsaturated carboxylic
acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,2-
cycloalkanedicarboxylic acid, 1,2-bis(2-oxiranylalkyl) ester, reaction
products with unsaturated carboxylic acid (PMN P-22-167) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), 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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=460.
(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. 721.12101 Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-
substituted polycarbocyclicalkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, polyfluoro-heteroatom-substituted
polycarbocyclicalkanesulfonate (1:1) (PMN P-22-192; Accession No.
302579) 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (2)(i) through (iii) and (v), (3)(i)
and (ii) and (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, 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), (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 a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12102 Formaldehyde, polymer with phenol, carboxyalkyl
ethers, alkali salts, compds. with (dialkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with phenol, carboxyalkyl ethers, alkali salts,
compds. with (dialkylamino)alkanol (PMN P-23-38) 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) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace
[[Page 14768]]
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), and (g)(1), (3)(iii) and (5). For purposes
of Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, serious eye damage, skin sensitization, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a), (m), and (o). It is a significant new
use to manufacture or process the substance in any manner that results
in the generation of a vapor, mist, dust, or aerosol. It is a
significant new use to manufacture, process, or use the substance for
commercial use. It is a significant new use to process the substance
for use by a consumer as a consumer product.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=120.
(b) Specific requirements. The provisions of subpart A of this part
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. 721.12103 Oxirane, alkyl-, polymer with oxirane, monoethers with
polyethylene glycol alkenyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, alkyl-, polymer with oxirane, monoethers with polyethylene
glycol alkenyl ether (PMN P-23-42) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3)(iii) and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion,
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. It is a significant new use to
use the substance other than as an intermediate for use in producing
polymers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12104 Oxirane, alkyl-, polymer with oxirane, sulfate, ethers
with polyethylene glycol alkenyl ether, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, alkyl-, polymer with oxirane, sulfate, ethers with
polyethylene glycol alkenyl ether, salt (PMN P-23-43) 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) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3)(iii) and (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 and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance. It is a significant new use to
use the substance other than as an intermediate for use in producing
polymers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12105 Alkanoic acid, substituted, polymer with substituted
Alkanoic acid, from fermentation of fermentable sugars (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, substituted, polymer with substituted Alkanoic acid,
from fermentation of fermentable sugars (PMN P-23-61; Accession No.
302397) 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 reacted or cured or when incorporated
into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as
[[Page 14769]]
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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, skin
sensitization, and eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to 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. 721.12106 2-Propenoic acid, 2-methyl-, C13-15-branched and
linear alkyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, C13-15-branched and linear alkyl esters (PMN P-23-74; CASRN
90552-04-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted such that less than 1 percent of
the substance remains.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(3)(iii) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) 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 (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. 721.12107 Alken-1-ol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alken-
1-ol (PMN P-23-126; Accession No. 302580) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), 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. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3)(iii) and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion, skin
irritation, serious eye damage, eye irritation, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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. 721.12108 Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-
, salt with dihalo-sulfoalkyl trisubstituted benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis (dihalo carbomonocycle) carbomonocycle-, salt with
dihalo-sulfoalkyl trisubstituted benzoate (PMN P-23-176; Accession No.
302386) 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), (2)(i) and (iii) and (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (2)(i) through (iii) and (v), (3)(i)
and (ii) and (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, 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), (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 a dust, mist, or
aerosol in
[[Page 14770]]
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. 721.12109 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-,
salt with substituted-dihalobenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt with
substituted-dihalobenzoate (PMN P-23-179) 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), (2)(i) and (iii) and (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (2)(i) through (iii) and (v), (3)(i)
and (ii) and (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 a 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. 721.12110 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-,
salt with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle)
carbopolycycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt with (dihalo-
sulfoalkyl) (halo-substituted carbomonocycle) carbopolycycle (PMN P-24-
42) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or adhered (during 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), (2)(i) and (iii) and (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (2)(i) through (iii) and (v), (3)(i)
and (ii) and (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, 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), (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 a 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. 721.12111 Sulfonium, tris(4-fluorophenyl)-,
(substitutedphenoxy)alkyl substitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tris(4-fluorophenyl)-, (substitutedphenoxy)alkyl
substitutedbenzoate (1:1) (PMN P-24-97) 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), (2)(i) and (iii) and (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general
[[Page 14771]]
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), and (g)(1), (2)(i) through (iii) and (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(e), the concentration
is set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: acute toxicity, skin irritation, serious eye damage, skin
sensitization, genetic toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2025-05480 Filed 4-3-25; 8:45 am]
BILLING CODE 6560-50-P