[Federal Register Volume 89, Number 113 (Tuesday, June 11, 2024)]
[Proposed Rules]
[Pages 49770-49796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12620]
[[Page 49769]]
Vol. 89
Tuesday,
No. 113
June 11, 2024
Part V
Environmental Protection Agency
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40 CFR Part 721
Significant New Use Rules on Certain Chemical Substances (23-3.5e);
Proposed Rule
Federal Register / Vol. 89 , No. 113 / Tuesday, June 11, 2024 /
Proposed Rules
[[Page 49770]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2023-0328; FRL-11825-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (23-
3.5e)
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 chemical substances that were
the subject of premanufacture notices (PMNs) and are also subject to a
TSCA Order. A SNUR requires persons who intend to manufacture (defined
by statute to include import) or process a particular chemical
substance for an activity that is identified as a significant new use
in the SNUR to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
conditions of use identified in the notification to EPA. 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 July 11, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0328, online at https://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting and visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: 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: 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 chemical substances that were the
subject of PMNs as discussed in Unit III. These SNURs, if finalized as
proposed, would require persons who intend to manufacture or process
any of these chemical substances for an activity that is designated as
a significant new use to notify EPA at least 90 days before commencing
that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances contained in this proposed rule. The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS) codes 325 and 324110, e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification rules under TSCA (https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to the import provisions in TSCA
section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR
12.118 through 12.127 (see also 19 CFR 127.28), and the EPA policy in
support of import certification at 40 CFR part 707, subpart B. Chemical
importers must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including
regulations issued under TSCA sections 5, 6, 7 and TSCA 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 July 11, 2024 are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing significant
new use notice (SNUN) reporting requirements for potential
manufacturers (including importers) and processors of the chemical
substances subject to these proposed SNURs. This analysis, which is
available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of
[[Page 49771]]
export notifications for the chemical substances covered by these
SNURs, as stated in the accompanying economic analysis, the estimated
cost of the export notification requirement on a per unit basis is
approximately $106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made by EPA 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 for the chemical substances,
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. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) Orders requiring the use of
appropriate exposure controls were negotiated with the PMN submitters.
As a general matter, EPA believes it is necessary to follow the TSCA
Orders with a SNUR that identifies the absence of those protective
measures as significant new uses to ensure that all manufacturers and
processors--not just the original submitter--are held to the same
standard.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying TSCA Orders,
consistent with TSCA section 5(f)(4).
To have an opportunity to review and evaluate data
submitted in a SNUN before the submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Chemical
Substance Inventory (TSCA) Inventory. Guidance on how to determine if a
chemical substance is on the TSCA Inventory is available at https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final
determination or other disposition of the confidentiality claim under
40 CFR part 2 procedures, EPA is required to keep this information
confidential. EPA promulgated a procedure to deal with the situation
where a specific significant new use is CBI, at 40 CFR 721.11.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends 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 tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR 721.11
into a single step.
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If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
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
conditions of 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 conditions of use of the chemical substance is not
likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to publish a statement of EPA's findings in the Federal
Register.
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
substances and the PMN submitters are required by the TSCA Orders to
submit a SNUN before undertaking activities which 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 at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to or reasonably ascertainable by
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the
Agency has the authority to require appropriate testing. To assist with
EPA's analysis of the SNUN, submitters are encouraged, but not
required, to provide the potentially useful information 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.C. for
these chemical substances 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
information 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 to provide useful
[[Page 49773]]
information with their SNUN submission.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
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 June 11, 2024 as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.D.
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 this document).
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
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 rules 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 the proposed SNURs in this
document?
The substances subject to the proposed rules in this document are
as follows:
PMN Number (Proposed CFR Citation): P-20-96 (40 CFR 721.11829)
Chemical Name: Unsaturated dicarboxylic acid polymer with 2-
(dialkylamino)alkyl-alkyl-alkanoate, N,N-dialkyl-alkene amide, 2-
propenamide and salt of alkyl-substituted alkene sulfonate (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 8, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in a papermaking process. Based on a
structural alert for aliphatic amines, the acid moieties, and a
confidential residual substance, EPA has identified concerns for skin,
eye, and respiratory tract irritation. Based on comparison to analogous
polyamphoteric polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 490 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:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified gas/vapor respirator with an APF
of at least 10 where there is a potential for inhalation exposure;
No manufacture of the PMN substance unless the percentage
of the confidential reactant listed in the Order represents 10% or less
(by weight) of the PMN substance;
No release of the PMN substance resulting in surface water
concentrations that exceed 490 ppb; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of 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 (Proposed CFR Citation): P-21-2 (40 CFR 721.11830)
Chemical Name: Octadecanoic acid, 12-hydroxy-, polymer with
aziridine, 2-oxepanone and tetrahydro-2H-pyran-2-one, reaction products
with disubstituted heteropolycycle (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 4, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymer in coatings. Based on a
structural alert for aliphatic amines, EPA has identified concerns for
lung effects (cationic binding) and irritation to the skin, eyes, and
respiratory tract. Based on comparison to analogous polycationic
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 50 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 use of the PMN substance in consumer products;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 50 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure during non-
spray applications;
Use of a NIOSH-certified respirator with an APF of at
least 10,000 where there is a potential for inhalation exposure during
spray applications;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has
[[Page 49774]]
determined that the results of skin irritation, eye irritation/
corrosion, pulmonary effects, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number (Proposed CFR Citation): P-21-19 (40 CFR 721.11831)
Chemical Name: Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 17, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a fragrance ingredient. Based on submitted
test data on PMN substance, EPA has identified concerns for acute
neurotoxicity and kidney effects, and 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 or the environment. To protect against
these risks, the Order requires:
No use of the PMN substance other than as a fragrance
ingredient for making fragrance oils by blending (mixing) with other
fragrance ingredients;
No use of the PMN substance at a concentration of 0.5% (by
weight) or greater in consumer products;
No domestic manufacture of the PMN substance (i.e., import
only);
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-21-48 (40 CFR 721.11832), P-21-
130 (40 CFR 721.11833), P-21-131 (40 CFR 721.11834), P-21-177 (40 CFR
721.11835), P-21-204 (40 CFR 721.11836), and P-22-12 (40 CFR 721.11837)
Chemical Names: Sulfonium, tricarbocyclic-, polyfluoropolyhydro-
2,2-dicarbocyclic -4,7-methano-1,3-benzodioxole-5-alkanesulfonate (1:1)
(generic) (P-21-48), Sulfonium, tricarbocyclic-, 2-[3,5-
bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) (generic) (P-21-130), Sulfonium, tricarbocyclic-,
2-(4-alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate
(1:1) (generic) (P-21-131), Sulfonium,
monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) (generic) (P-21-177), Sulfonium, bis(3,4-
polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) (generic) (P-21-204), and Sulfonium,
tricarbocyclic-, 2-heteroatom-substituted-4-
(halocarbocyclic)carboxylate (1:1) (generic) (P-22-12).
CASRNs: Not available.
Effective Date of TSCA Order: December 22, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography.
Based on the physical/chemical properties of the PMN substances (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 1999) and in the absence of data, the PMN substances and
photolysis products are potentially persistent, bioaccumulative, and
toxic (PBT) chemicals. EPA estimates that the PMN substances will
persist in the environment for more than two months and that their
potential to bioaccumulate is unknown. EPA estimates that the
photolysis products will persist in the environment for more than two
months and estimates a bioaccumulation factor of greater than or equal
to 1,000. Based on the reactivity of the PMN substances, EPA has
identified concerns for photosensitization. Based on information
provided in the SDS and data on analogues, EPA has also identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on data on sulfonium compounds, EPA has also 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 substances. Based on
comparison to analogous substances, EPA has also identified concerns
for mutagenicity. Based on analogue data, EPA has also identified
concerns for thyroid, liver, and reproductive (developmental) toxicity
for the anion for PMNs P-21-48, P-21-130, P-21-131, P-21-177, and P-21-
204. Based on test data on salicylic acid and sodium salicylate and a
structural alert for phenols, EPA has also identified concerns for
acute toxicity, eye irritation, neurotoxicity, reproductive and
developmental effects for P-22-12. Based on protein binding alert for
benzyl phenyl ethers, EPA has also identified concerns for skin
sensitization for P-22-12. Based on data on a potential incineration
product, EPA has identified concerns for local and systemic effects.
Based on insufficient information, the PMN substance has unknown
toxicity to aquatic organisms. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substances may present an unreasonable risk of injury to human health
or the environment. To protect against these risks, the Order requires:
No manufacture of any of the PMN substances beyond the
time limits specified in the Order without submittal to EPA the results
of certain testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No modification of the processing or use 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 use
stated in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
[[Page 49775]]
Import of the PMN substances only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes stated in 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 (Proposed CFR Citation): P-21-55 (40 CFR 721.11838)
Chemical Name: Fatty acids, reaction products with polyamine-
polyacid polymer and fatty acid (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 29, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an adhesive used for coating formulations.
Based on structural alert for aliphatic amines, EPA has identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on a potential metabolite and confidential residual, EPA has also
identified concerns for systemic (body weight, adrenal, and clinical
chemistry), reproductive, and developmental effects. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
Manufacture of the PMN substance only in a manner that
results in an amine value of no more than 127 mg KOH/g;
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
irritation, eye damage, 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 Numbers (Proposed CFR Citations): P-21-71 (40 CFR 721.11839) and P-
21-72 (40 CFR 721.11840)
Chemical Names: Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-(1-methylethoxy)-, sodium salt (1:1) (P-21-71)
and Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-
butoxy-, sodium salt (1:1) (P-21-72).
CASRNs: 2304726-53-0 (P-21-71) and 2304726-56-3 (P-21-72).
Effective Date of TSCA Order: October 5, 2022.
Basis for TSCA Order: The PMNs state that the uses will be as
flotation aids in sulfide ore mining. Based on surfactant properties,
EPA has identified concerns for lung effects and skin and eye
irritation. Based on data on carbon disulfide, EPA has also identified
concerns for neurotoxicity and systemic, reproductive, and
developmental effects for the hydrolysis product. Based on comparison
to analogous esters, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 350 ppb (P-21-71) and 150 ppb (P-
21-72). 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:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No use of the PMN substances other than as flotation aids
in sulfide ore mining at mines with valid permits (State, Federal, or
Tribal) for operations and waste handling;
No domestic manufacture of the PMN substances (i.e.,
import only); and
No release of the PMN substances resulting in surface
water concentrations that exceed 150 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, developmental toxicity, eye damage, neurotoxicity,
reproductive toxicity, skin irritation, specific target organ toxicity,
and pulmonary effects testing may be potentially useful to characterize
the health and environmental effects of the PMN substances. Although
the Order does not require these tests, the Order's restrictions remain
in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-21-73 (40 CFR 721. 11841)
Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester,
branched and linear.
CASRN: 2449089-78-3.
Effective Date of TSCA Order: September 1, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
plasticizer in PVC articles like roofing membranes, flooring, or coated
fabrics. Based on the potential hydrolysis product, EPA has identified
concerns for reproductive and developmental effects. Based on test data
on the PMN substance and comparison to neutral organic substances, EPA
predicts the PMN substance may be toxic to aquatic organisms and has
unknown toxicity to sediment dwelling environmental organisms. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information
[[Page 49776]]
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:
Use of personal protective equipment where there is a
potential for dermal exposure;
No processing or use of the PMN substance in a consumer
product;
No processing or use of the PMN substance other than as a
plasticizer in polyvinyl chloride (PVC) articles;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No release of the PMN substance, or any waste stream
containing the PMN substance, into water or into any environmental
media destined for water.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require this test, 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 (Proposed CFR Citation): P-21-74 (40 CFR 721.11842)
Chemical Name: 1,3-Butadiene, homopolymer, hydrogenated, 2-
(ethenyloxy)ethyl-terminated.
CASRN: 2511154-73-5.
Effective Date of TSCA Order: March 28, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a resin component of an adhesive
formulation. Based on potential epoxidation of the terminal C=C bonds,
EPA has identified concerns for dermal and respiratory sensitization,
reproductive and developmental effects, genotoxicity, and
carcinogenicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
No use of the PMN substance in consumer products;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
Use of the PMN substance only for the confidential use
listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
Use of 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.
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
sensitization, germ cell mutagenicity, specific target organ toxicity,
reproductive toxicity, and developmental toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-21-89 (40 CFR 721.11843) and P-
21-90 (40 CFR 721.11844)
Chemical Names: Lignin, modified, reaction products with alkylamine
by-products, hydrochlorides (generic) (P-21-89) and Lignin, modified,
reaction products with alkylamine by-products (generic) (P-21-90).
CASRNs: Not available.
Effective Date of TSCA Order: July 25, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as an emulsifier (P-21-89) and a component
in paving formulations (P-21-90). Based on the cationic binding of
amines to lung membranes, EPA has identified concerns for lung effects.
Based on analogue data, EPA has also identified concerns for corrosion
to the skin and eyes for P-21-90. Based on comparison to analogous
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 2 ppb (P-21-89). Based on
comparison to analogous polyamphoteric polymers, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 12 ppb (P-
21-90). 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:
Use of personal protective equipment where there is a
potential for dermal exposure to P-21-90;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No manufacture, processing, or use in any manner that
results in inhalation exposure;
No manufacture, processing, or use in any manner that
results in direct air releases to the environment except during loading
or unloading of transport containers;
No release of PMN P-21-89 resulting in surface water
concentrations that exceed 2 ppb; and
No release of PMN P-21-90 resulting in surface water
concentrations that exceed 12 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity and specific target organ toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substances. EPA has also determined that the results of skin corrosion
and serious eye damage testing may be potentially useful to
characterize the health effects of P-21-90. 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 (Proposed CFR Citation): P-21-124 (40 CFR 721.11845)
Chemical Name: Sulfonium, triphenyl-, salt with fluoroalkyl 5-
[[Page 49777]]
sulfobicyclo[2.2.1]heptane carboxylate (1:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: December 22, 2022.
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 in the absence of data, the PMN substance is a
potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA
estimates that the PMN substance may potentially persist in the
environment for more than six months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on the reactivity of
the PMN substance, EPA has identified concerns for photosensitization.
Based on data on sulfonium compounds, EPA has also 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 comparison to analogous substances, EPA has also identified concerns
for genetic toxicity. Based on perfluoro analogue data, EPA has also
identified concerns for thyroid, liver, and reproductive
(developmental) toxicity for the anion. Based on data on a potential
incineration product, EPA has also identified concerns for local and
systemic effects. Based on insufficient information, the PMN substance
has unknown toxicity to aquatic organisms. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No 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 as an onium salt that
generates strong or weak acid in lithography process;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed in 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 (Proposed CFR Citation): P-21-137 (40 CFR 721.11846)
Chemical Name: Triazine-trione, tris(isocyanatoalkyl)-, polymer
with substituted diisocyanato alkylcarbomonocycle, hydro-
hydroxypoly(oxyalkanediyl)and hydro-hydroxypoly[oxy(alkyl-alkanediyl)],
aliphatic alkyl amine-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 3, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an industrial additive. Based on
information in the SDS, comparison to analogous chemical substances,
and test data on a residual, EPA has identified concerns for eye, skin,
and respiratory irritation, eye and skin corrosion, acute toxicity,
acute neurotoxicity, systemic effects, portal-of-entry effects,
mutagenicity, and reproductive effects. Based on the potential of the
PMN substance as a crosslinker, EPA has also identified concerns for
skin sensitization. Based on comparison to analogous substituted ureas,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 15 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 use of the PMN substance in consumer products;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 15 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
reproductive toxicity, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Number (Proposed CFR Citation): P-21-138 (40 CFR 721.11847)
Chemical Name: Lithium metal oxide (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 31, 2022.
Basis for TSCA Order: The PMN states that the use will be as an
electrode material for use in the manufacture of batteries. Based on
the physical/chemical properties of the PMN substance and comparison to
analogous respirable, poorly soluble particulates, EPA has identified
concerns for lung effects (lung overload). Based on comparison to
analogous chemical substances, EPA has also identified concerns for
systemic, reproductive, and developmental effects. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
[[Page 49778]]
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:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate respirator with an
APF of at least 1,000 if the dust control capture and reduction rate is
at less than 90% where there is a potential for inhalation exposure;
Use of a NIOSH-certified particulate respirator with an
APF of at least 50 if the dust control capture and reduction rate is at
least 90% where there is a potential for inhalation exposure;
No domestic manufacture of the PMN substance (i.e., import
only);
No disposal of the PMN substance or waste streams
containing the PMN substance other than by landfill or incineration;
No use of the PMN substance in a consumer product;
No use of the PMN substance other than in the manufacture
of batteries; 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 testing may be potentially useful to characterize the health
effects of the PMN substance. Although the Order does not require this
test, 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 (Proposed CFR Citation): P-21-140 (40 CFR 721.11848)
Chemical Name: Soybean oil, oleic acid-high, epoxidized.
CASRN: 2410202-82-1.
Effective Date of TSCA Order: September 1, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
chemical intermediate to prepare acrylate-containing oil, which is
subsequently polymerized to prepare a viscosity modifier for asphalt.
Based on analogous epoxides, EPA has identified concerns for
reproductive effects and carcinogenicity. Based on OECD QSAR Toolbox
results and test data for a functional analogue, 4-vinylcyclohexene
diepoxide, EPA has also identified concerns for carcinogenicity. Based
on test data for an analogue, epoxidized soybean oil, EPA has also
identified concerns for systemic effects and reproductive effects.
Based on OECD QSAR Toolbox identification as a respiratory sensitizer,
the new chemical substance having bifunctional reactive groups which
can crosslink proteins, and the respiratory tract not having a stratum
corneum protective layer like the skin to inhibit absorption, EPA has
also identified concerns for respiratory sensitization. Based on
insufficient information, toxicity to sediment-dwelling organisms is
unknown. 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:
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste steam
containing the PMN substance, into waters of the United States;
No use of the PMN substance other than as a chemical
intermediate to prepare acrylate-containing oil, which is subsequently
polymerized to prepare a viscosity modifier for asphalt;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, skin irritation, eye irritation/
corrosion, reproductive toxicity, developmental toxicity,
carcinogenicity, and sediment organism 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 (Proposed CFR Citation): P-21-180 (40 CFR 721.11849)
Chemical Name: Sulfonium, (halocarbomonocycle)diphenyl-, salt with
1-heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: December 20, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be 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 the absence
of data, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
substance will persist in the environment for more than six months and
the bioaccumulation potential is unknown and that the cation photolysis
product has the potential to bioaccumulate and be persistent in the
environment. Based on the reactivity of the PMN substance, EPA has
identified concerns for photosensitization. Based on data on sulfonium
compounds and information provided in the SDS, EPA has also 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 comparison to analogous substances, EPA has also
identified concerns for mutagenicity. Based on analogue data and the
OECD QSAR Toolbox, EPA has also identified concerns for thyroid, liver,
and reproductive (developmental) toxicity and skin sensitization for
the anion. Based on data on a potential incineration product, EPA has
identified concerns for local and systemic effects. Based on
insufficient information, the PMN substance has unknown toxicity to
aquatic organisms. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
[[Page 49779]]
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No 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
stated in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed in 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 (Proposed CFR Citation): P-21-199 (40 CFR 721.11850)
Chemical Name: 1,6-Disubstituted hexane (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 7, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a processing aid. Based on comparison to
analogous chemical substances, EPA has identified concerns for acute
toxicity, irritation to the skin, eyes, and respiratory tract,
respiratory and skin sensitization, neurotoxicity, systemic effects,
genotoxicity, reproductive, and developmental effects. Based on
structural alerts, EPA has also identified concerns for
carcinogenicity. Based on comparison to analogous chemical substances,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 23 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
No release of the PMN substance, or any waste steam
containing the PMN substance, into waters of the United States;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No disposal of the PMN substance or waste streams
containing the PMN substance other than by hazardous waste
incineration;
No use of the PMN substance in a consumer product; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye damage, skin irritation, pulmonary effects, skin
sensitization, specific target organ toxicity, neurotoxicity, genetic
toxicity, reproductive toxicity, developmental toxicity,
carcinogenicity, and aquatic toxicity testing may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-21-201 (40 CFR 721.11851)
Chemical Name: 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-N3-tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N1-
hexadecyl-2-hydroxy-N1,N1,N3,N3,N3-pentamethyl-, chloride (1:2); 1,3-
Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-,
chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-N3-octadecen-1-yl, chloride (1:2).
CASRNs: 1622255-87-1; 63560-76-9; 197862-16-1; and 2748681-38-9.
Effective Date of TSCA Order: April 12, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
surfactant in a cationic latex asphalt emulsion formulation. Based on
the intended use and structure, EPA has identified concerns for
surfactant effects of the lung. Based on comparison to analogous
chemical substances, EPA also identified concerns for skin irritation/
corrosion, eye irritation/corrosion, mortality, systemic, and
neurotoxic, and developmental effects. Based on comparison to analogous
cationic (quaternary ammonium) surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 21 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 use of the PMN substance in consumer products;
No manufacture, processing, or use of the PMN substance in
any manner or method that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 21 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, acute toxicity, neurotoxicity, specific target organ
toxicity, pulmonary
[[Page 49780]]
effects, developmental toxicity, skin irritation, skin corrosion, and
eye damage 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 (Proposed CFR Citation): P-21-206 (40 CFR 721.11852)
Chemical Name: Alkanes, branched and linear (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 25, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of
gasoline. Based on data on analogous mixtures, EPA has identified
concerns for skin irritation, neurotoxicity, systemic toxicity,
developmental toxicity, portal-of-entry effects via the inhalation
route, and carcinogenicity. Based on data on representative
constituents of the PMN substance, EPA has also identified concerns for
eye irritation, acute toxicity, acute neurotoxicity, reproductive
toxicity, portal-of-entry effects via the oral route, aspiration
hazard, and genetic toxicity. Based on information provided in the SDS,
EPA has also identified concerns for aspiration hazard, flammability,
skin irritation, eye irritation, and acute neurotoxicity. Based on the
chemical composition, EPA has also identified hydrocarbon pneumonia/
aspiration hazard. EPA also assumes respiratory tract irritation is a
hazard. Based on comparison to analogous neutral organic substances,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 3 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substance
other than for use as a fuel, fuel additive, or regulated blendstock
subject to 40 CFR part 79 or 1090, including as a component of gasoline
or ethanol base fuel (E85);
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program.
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 irritation, respiratory depression/irritation,
hydrocarbon pneumonia/aspiration hazard, reproductive developmental
toxicity, systemic toxicity, genetic toxicity, carcinogenicity, aquatic
toxicity, and consumer inhalation exposure at gas stations 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 (Proposed CFR Citations): P-22-29 (40 CFR 721.11853), P-22-
30 (40 CFR 721.11854), and P-22-31 (40 CFR 721.11855)
Chemical Names: Polyester with 1,4-benzenedicarboxylic acid, 1,4-
dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3- hydroxy-
2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (generic)
(P-22-29), Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-
1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic
polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4-
isocyanatobenzene] (generic) (P-22-30), and Polyester with 1,4-
benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic
acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl
3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-
methylenebis[isocyanatobenzene] (generic) (P-22-31).
CASRNs: Not available.
Effective Date of TSCA Order: January 6, 2023.
Basis for TSCA Order: The PMNs state that the uses will be as
industrial adhesives. Based on comparison to analogous diisocyanates,
EPA has identified concerns for irritation to skin, eyes, and
respiratory tract, skin and respiratory sensitization, and pulmonary
toxicity for the low molecular weight species present in the PMN
substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health or the
environment. To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure;
No use of the PMN substances in consumer products;
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.
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, skin irritation, eye irritation, skin sensitization,
and specific target organ toxicity 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 (Proposed CFR Citation): P-22-55 (40 CFR 721.11856)
Chemical Name: Aromatic sulfonium tricyclo fluoroalkyl sulfonic
acid salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 31, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a photoacid generator
(PAG) for use in electronics industry. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and in the
absence of data, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
[[Page 49781]]
substance will persist in the environment for more than six months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on the reactivity of the PMN substance, EPA has identified
concerns for photosensitization. Based on test data on the PMN
substance and information provided in the SDS, EPA has also identified
concerns for eye irritation and corrosion, skin and eye corrosion, and
corrosion to mucous membranes. Based on data on sulfonium compounds,
EPA has also 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 comparison to analogous substances, EPA has
also identified concerns for genetic and acute toxicity, eye irritation
and corrosion, and systemic effects. Based on perfluoro analogue data,
EPA has also identified concerns for thyroid, liver, and reproductive
(developmental) toxicity for the anion of the PMN substance. Based on
data on a potential incineration product, EPA identified hazards for
local and systemic effects. EPA was unable to estimate the
environmental hazard of this substance. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No 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 as a photoacid generator;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed in 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 (Proposed CFR Citation): P-22-69 (40 CFR 721.11857)
Chemical Name: Fluoroheteroacid, metal salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 24, 2022.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in batteries. Based on
submitted test data on the PMN substance, EPA has identified concerns
for acute toxicity, skin, respiratory and eye corrosion, skin
sensitization, and systemic effects. Based on data on the hydrolysis
product, EPA has also identified concerns for systemic, reproductive,
and developmental effects. Based on submitted test data on the PMN
substance and comparison to analogous chemical substances, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
380 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:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate respirator with an
APF of at least 50 where there is a potential for inhalation exposure;
No use of the PMN substance in a consumer product;
No release of the PMN substance resulting in surface water
concentrations that exceed 380 ppb; and
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects, developmental effects, specific target organ
toxicity, and chronic fish 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 (Proposed CFR Citation): P-22-147 (40 CFR 721.11858)
Chemical Name: Hydrocarbons, C5-10.
CASRN: 2779559-23-6.
Effective Date of TSCA Order: November 2, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
feedstock for gasoline for racing fuels. Based on comparison to
analogous chemical mixtures and data on the worst case constituents of
the PMN substance, EPA has identified concerns for irritation to the
skin, eye, and respiratory tract, acute toxicity, developmental and
reproductive effects, systemic effects, aspiration hazard, genetic
toxicity, and carcinogenicity. Based on data on constituents of the
mixture, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 25 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
Import, processing, and use of the PMN substance only as a
feedstock for gasoline containing no more than 64% of the PMN substance
where the imported gasoline mixture is regulated under applicable EPA
regulations for fuels, fuel additives, and regulated blendstocks (40
CFR part 1090), fuel additives, and regulated blendstocks (40
[[Page 49782]]
CFR part 1090), registration of fuels and fuel additives (40 CFR part
79).
No domestic manufacture of the PMN substance (i.e., import
only);
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, skin irritation, eye irritation, reproductive/developmental
toxicity, systemic toxicity, genetic toxicity, and carcinogenicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-22-150 (40 CFR 721.11859),
P-22-152 (40 CFR 721.11860), P-22-161 (40 CFR 721.11861), and P-22-177
(40 CFR 721.11862).
Chemical Names: Sulfonium, tricarbocyclic-, alpha, alpha, beta,
beta-polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1)
(generic) (P-22-150), Sulfonium, tricarbocyclic-, 2-heteroatom-
substituted-4-alkylcarbomonocyclecarboxylate (1:1) (generic) (P-22-
152), Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-
(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl
ester (1:1) (generic) (P-22-161), and Sulfonium, tricarbocyclic-,
alpha, alpha, beta, beta-polyhalopolyhydro-heteropolycyclic-5-
alkanesulfonate (1:1) (generic) (P-22-177).
CASRNs: Not available.
Effective Date of TSCA Order: February 6, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography.
Based on the physical/chemical properties of the PMN substances (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 1999) and in the absence of data, the PMN substances 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 have unknown bioaccumulation potential. EPA
also estimates that the cation photodegradation products will persist
in the environment for more than two months and have bioaccumulation
factors over 1000. Based on data 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 cations of the PMN
substances. Based on the photoreactivity of the PMN substances, EPA has
also identified concerns for photosensitization. Based on the
reactivity of the PMN substances, EPA has also identified irritation to
the skin, eyes, and respiratory tract. Based on comparison to analogous
substances, EPA has also identified concerns for mutagenicity. Based on
OECD QSAR Toolbox results, EPA has also identified hazards for skin
sensitization for P-22-150, P-22-161, and P-22-177, and carcinogenicity
for P-22-161 and P-22-177, and skin sensitization and carcinogenicity
for the anion of P-22-161. Based on anion analogue data, EPA has also
identified concerns for acute toxicity, skin irritation, eye corrosion,
GI tract irritation, and systemic, reproductive and developmental
effects for P-22-150, P-22-161, and P-22-177. Based on data 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 these substances. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
No manufacture of any of the PMN substances beyond the
time limits specified in the Order without submittal to EPA the results
of certain testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
No processing of the PMN substances in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use
stated in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed in 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.
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 and Executive
Order 14094: Modernizing Regulatory 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), as amended by Executive
Order 14094 (88 FR 21879, April 11, 2023).
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
[[Page 49783]]
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 through the use of 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 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 16 in Federal fiscal year (FY) FY2018,
five in FY2019, seven in FY2020, 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 any one year (in 1995 dollars) 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. 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 human health, 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 any of these chemical substances for an activity that is
designated as a significant new use by this rulemaking. This
notification allows EPA to assess the conditions of use 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).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
This action does not concern human health or environmental
conditions and therefore cannot be evaluated with respect to the
potential for disproportionate impacts on non-white and low-income
populations in accordance with Executive Order 12898 (59 FR 7629,
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26,
2023). Although this action does not concern human health or
environmental conditions, the premanufacture notifications required by
these SNURs allow EPA to assess the conditions of use to identify
potential disproportionate risks and take appropriate actions before
the activities commence.
[[Page 49784]]
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 4, 2024.
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. 721.11829 through 721.11862 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11829 Unsaturated dicarboxylic acid polymer with 2-
(dialkylamino)alkyl-alkyl-alkanoate, N,N-dialkyl-alkene amide, 2-
propenamide and salt of alkyl-substituted alkene sulfonate
(generic).
721.11830 Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-
oxepanone and tetrahydro-2H-pyran-2-one, reaction products with
disubstituted heteropolycycle (generic).
721.11831 Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
721.11832 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-
dicarbocyclic -4,7-methano- 1,3-benzodioxole-5-alkanesulfonate (1:1)
(generic).
721.11833 Sulfonium, tricarbocyclic-, 2-[3,5-
bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) generic).
721.11834 Sulfonium, tricarbocyclic-, 2-(4-
alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate
(1:1) (generic).
721.11835 Sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-
1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic).
721.11836 Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha.,
.alpha., .beta, .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-
heteropolycyclic-5-alkanesulfonate (1:1) (generic).
721.11837 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(halocarbocyclic)carboxylate (1:1) (generic).
721.11838 Fatty acids, reaction products with polyamine-polyacid
polymer and fatty acid (generic).
721.11839 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-(1-methylethoxy)-, sodium salt (1:1).
721.11840 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-butoxy-, sodium salt (1:1).
721.11841 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester,
branched and linear.
721.11842 1,3-Butadiene, homopolymer, hydrogenated, 2-
(ethenyloxy)ethyl-terminated.
721.11843 Lignin, modified, reaction products with alkylamine by-
products, hydrochlorides (generic).
721.11844 Lignin, modified, reaction products with alkylamine by-
products (generic).
721.11845 Sulfonium, triphenyl-, salt with fluoroalkyl 5-
sulfobicyclo[2.2.1]heptane carboxylate (1:1) (generic).
721.11846 Triazine-trione, tris(isocyanatoalkyl)-, polymer with
substituted diisocyanato alkylcarbomonocycle, hydro-
hydroxypoly(oxyalkanediyl)and hydro-hydroxypoly[oxy(alkyl-
alkanediyl)], aliphatic alkyl amine-blocked (generic).
721.11847 Lithium metal oxide (generic).
721.11848 Soybean oil, oleic acid-high, epoxidized.
721.11849 Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-
heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (generic).
721.11850 1,6-Disubstituted hexane (generic).
721.11851 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-N3-tetradecyl-, chloride (1:2); 1,3-Propanediaminium,
N1-hexadecyl-2-hydroxy-N1,N1,N3,N3,N3-pentamethyl-, chloride (1:2);
1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-
octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-
N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-yl, chloride (1:2).
721.11852 Alkanes, branched and linear (generic).
721.11853 Polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl
1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3- hydroxy-
2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene]
(generic).
721.11854 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-
1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic
polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
721.11855 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-
1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic
polyester, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-
methylenebis[isocyanatobenzene] (generic).
721.11856 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(generic).
721.11857 Fluoroheteroacid, metal salt (generic).
721.11858 Hydrocarbons, C5-10.
721.11859 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
721.11860 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
alkylcarbomonocyclecarboxylate (1:1) (generic).
721.11861 Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-
5-(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl
polyhaloaryl ester (1:1) (generic).
721.11862 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
* * * * *
Sec. 721.11829 Unsaturated dicarboxylic acid polymer with 2-
(dialkylamino)alkyl-alkyl-alkanoate, N,N-dialkyl-alkene amide, 2-
propenamide and salt of alkyl-substituted alkene sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
unsaturated dicarboxylic acid polymer with 2-(dialkylamino)alkyl-alkyl-
alkanoate, N,N-dialkyl-alkene amide, 2-propenamide and salt of alkyl-
substituted alkene sulfonate (PMN P-20-96) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 10. 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), (g)(1), (3), 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
[[Page 49785]]
substance may cause: skin corrosion and eye irritation. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance unless the percentage
of the confidential reactant listed in the Order represents 10% or less
(by weight) of the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=490.
(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. 721.11830 Octadecanoic acid, 12-hydroxy-, polymer with
aziridine, 2-oxepanone and tetrahydro-2H-pyran-2-one, reaction products
with disubstituted heteropolycycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and
tetrahydro-2H-pyran-2-one, reaction products with disubstituted
heteropolycycle (PMN P-21-2) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 during non-spray
applications or 10,000 during spray applications. 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), (g)(1), (3), 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. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. 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=50.
(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. 721.11831 Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ethyl
4-alkyl-2-oxocycloalkanecarboxylate (PMN P-21-19) 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 the substance is present
at less than 0.5% in formulation.
(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), (g)(1), (3), 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: specific target organ toxicity.
For purposes of Sec. 721.72(g)(3), this substance may be: toxic to
aquatic life. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as a fragrance ingredient for making fragrance
oils by blending (mixing) with other fragrance ingredients. It is a
significant new use to use the substance at a concentration of 0.5% (by
weight) or greater in consumer products.
(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. 721.11832 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-
dicarbocyclic -4,7-methano- 1,3-benzodioxole-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-dicarbocyclic -4,7-
methano- 1,3-benzodioxole-5-alkanesulfonate (1:1) (PMN P-21-48) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering
[[Page 49786]]
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11833 Sulfonium, tricarbocyclic-, 2-[3,5-
bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl]-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-
heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-21-130) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: eye irritation, 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11834 Sulfonium, tricarbocyclic-, 2-(4-
alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta., .beta.-
polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate
(1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic)-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-4,7-methano-1,3-
heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-21-131) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49787]]
Sec. 721.11835 Sulfonium, monocarbocyclicbisarylpolyhaloalkyl,
.alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-
methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-
heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-21-177) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11836 Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-
heteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta.,
.beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-
alkanesulfonate (1:1) (PMN P-21-204) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11837 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-(halocarbocyclic)carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(halocarbocyclic)carboxylate (1:1) (PMN P-22-12) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: eye irritation, 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
[[Page 49788]]
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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11838 Fatty acids, reaction products with polyamine-
polyacid polymer and fatty acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, reaction products with polyamine-polyacid polymer and fatty acid
(PMN P-21-55) 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 they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. 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), (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 Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture the substance in a manner that results in an
amine value of more than 127 mg KOH/g.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11839 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-(1-methylethoxy)-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1-methylethoxy)-,
sodium salt (1:1) (PMN P-21-71; CASRN 2304726-53-0) 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), (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 (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. 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), (g)(1), (3), and (5). For the 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,
reproductive toxicity, and specific target organ toxicity. For purposes
of Sec. 721.72(g)(3), this substance may be toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80 (f). It is a significant new use to use the
substance other than as a floatation aid in sulfide ore mining at mines
with valid permits (State, Federal, or Tribal) for operations and waste
handling.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=150.
(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. 721.11840 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-butoxy-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-butoxy-, sodium salt
(1:1) (PMN P-21-72; CASRN 2304726-56-3) 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 (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. 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)
[[Page 49789]]
through (f), (g)(1), (3), and (5). For the 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, reproductive
toxicity, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as a floatation aid in sulfide ore mining at mines
with valid permits (State, Federal, or Tribal) for operations and waste
handling.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=150.
(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. 721.11841 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester,
branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear
(PMN P-21-73; CASRN 2449089-78-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely bound in a
PVC article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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), (g)(1), (3), and (5). For the 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: reproductive toxicity and
specific target organ toxicity. 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 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 process
or use the substance other than as a plasticizer in polyvinyl chloride
(PVC) articles. It is a significant new use to process the substance
for use in a consumer product.
(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. 721.11842 1,3-Butadiene, homopolymer, hydrogenated, 2-
(ethenyloxy)ethyl-terminated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-butadiene,
homopolymer, hydrogenated, 2-(ethenyloxy)ethyl-terminated (PMN P-21-74;
CASRN 2511154-73-5) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
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), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: respiratory sensitization, skin
sensitization, germ cell mutagenicity, specific target organ toxicity,
and reproductive toxicity. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(k) and (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)(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. 721.11843 Lignin, modified, reaction products with alkylamine
by-products, hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lignin,
modified, reaction products with alkylamine by-products, hydrochlorides
(PMN P-21-89) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For the 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 specific target organ toxicity.
For purposes of Sec. 721.72(g)(3), this substance may be toxic to
aquatic life. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
[[Page 49790]]
(ii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture, process, or use the substance in any manner
that results in inhalation exposure. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in direct air releases to the environment except during loading or
unloading of transport containers.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11844 Lignin, modified, reaction products with alkylamine
by-products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lignin,
modified, reaction products with alkylamine by-products (PMN P-21-90)
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) and (5). For the 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 specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture, process, or use the substance in any manner
that results in inhalation exposure. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in direct air releases to the environment except during loading or
unloading of transport containers.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=12.
(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. 721.11845 Sulfonium, triphenyl-, salt with fluoroalkyl 5-
sulfobicyclo[2.2.1]heptane carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with fluoroalkyl 5-
sulfobicyclo[2.2.1]heptane carboxylate (1:1) (PMN P-21-124) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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) and (t). It is a significant new use to
use the substance other than as an onium salt that generates strong or
weak acid in lithography process. It is a significant new use to import
the substance other than in solution or in sealed containers weighing 5
kilograms or less. It is a significant new use to process the substance
in any way that generates dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to manufacture the substance
longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11846 Triazine-trione, tris(isocyanatoalkyl)-, polymer with
substituted diisocyanato alkylcarbomonocycle, hydro-
hydroxypoly(oxyalkanediyl) and hydro-hydroxypoly[oxy(alkyl-
alkanediyl)], aliphatic alkyl amine-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted
diisocyanato alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl) and
hydro-hydroxypoly[oxy(alkyl-alkanediyl)], aliphatic alkyl amine-blocked
(PMN P-21-137) 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
[[Page 49791]]
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) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, skin irritation, skin sensitization, serious eye damage, eye
irritation, genetic toxicity, reproductive toxicity, specific target
organ toxicity, and respiratory irritation. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. 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=15.
(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. 721.11847 Lithium metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
metal oxide (PMN P-21-138) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1,000 if the dust control
capture and reduction rate is at less than 90% or at least 50 if the
dust control capture and reduction rate is at least 90%. 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), (g)(1), and (5). For the 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: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o). It is a significant new use to
use the substance other than in the manufacture of batteries.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(2), (b)(1) and (2), and (c)(1) and (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 (j) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11848 Soybean oil, oleic acid-high, epoxidized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean oil, oleic
acid-high, epoxidized (PMN P-21-140; CASRN 2410202-82-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a chemical
intermediate to prepare acrylate-containing oil, which is subsequently
polymerized to prepare a viscosity modifier for asphalt. 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)(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. 721.11849 Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-
heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-
heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (PMN P-21-180) 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
[[Page 49792]]
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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11850 1,6-Disubstituted hexane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,6-
disubstituted hexane (PMN P-21-199) 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 destroyed.
(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), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, respiratory sensitization, skin
sensitization, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. 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 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 exposures.
(iv) Disposal. It is a significant new use to dispose of the
substance other than by hazardous waste incineration.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11851 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-N3-tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N1-
hexadecyl-2-hydroxy-N1,N1,N3,N3,N3-pentamethyl-, chloride (1:2); 1,3-
Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-,
chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-N3-octadecen-1-yl, chloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-,
chloride (1:2); 1,3-propanediaminium, N1-hexadecyl-2-hydroxy-
N1,N1,N3,N3,N3-pentamethyl-, chloride (1:2); 1,3-propanediaminium, 2-
hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); 1,3-
propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-
yl, chloride (1:2) (PMN P-21-201; CASRNs 1622255-87-1; 63560-76-9;
197862-16-1; and 2748681-38-9) 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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (3), 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 corrosion,
skin irritation, serious eye damage, eye irritation, reproductive
toxicity, and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(o). It is a
[[Page 49793]]
significant new use to manufacture, process, or use the substance in
any manner or method 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=21.
(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. 721.11852 Alkanes, branched and linear (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanes, branched and linear (PMN P-21-206) 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 a
fuel.
(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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a).
(iii) Industrial, commercial, and consumer use. It is a significant
new use to manufacture, process, or use the substance other than as a
fuel, fuel additive, or regulated blendstock subject to 40 CFR parts 79
or 1090, including as a component of gasoline or ethanol base fuel
(E85).
(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. 721.11853 Polyester with 1,4-benzenedicarboxylic acid, 1,4-
dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3- hydroxy-
2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl 1,4-
benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3- hydroxy-2,2-dimethylpropyl 3-
hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-
methylenebis[isocyanatobenzene] (PMN P-22-29) 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 policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (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 Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. 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. 721.11854 Polyester with 1,4-benzenedicarboxylic acid, 2,2-
dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic
polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-
propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester,
3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'-methylenebis[4- isocyanatobenzene] (PMN P-
22-30) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been 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 policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (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 Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(o). It is a
[[Page 49794]]
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. 721.11855 Polyester with 1,4-benzenedicarboxylic acid, 2,2-
dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic
polyester, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-
methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-
propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester,
3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'- methylenebis[isocyanatobenzene] (PMN P-22-
31) 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 policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (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 Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. 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. 721.11856 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (PMN P-22-
55) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may cause: skin irritation, acute toxicity, skin corrosion, skin
sensitization, eye irritation, serious eye damage, specific target
organ toxicity, genetic toxicity, and reproductive (developmental)
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (t). It is a significant new use to
use the substance other than as a photoacid generator. It is a
significant new use to import the substance other than in solution,
unless in sealed containers weighing 5 kilograms or less. It is a
significant new use to process the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11857 Fluoroheteroacid, metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroheteroacid, metal salt (PMN P-22-69) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance 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), (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), (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
[[Page 49795]]
sensitization, reproductive toxicity, and specific target organ
toxicity. For purposes of Sec. 721.72(g)(3), this substance may be:
toxic to aquatic life. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and 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=380.
(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. 721.11858 Hydrocarbons, C5-10.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hydrocarbons, C5-10
(PMN P-22-147; CASRN 2779559-23-6) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been incorporated into
gasoline.
(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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a).
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f). It is a significant new use to import,
process, or use the substance other than as a feedstock for gasoline
containing no more than 64% of the substance where the imported
gasoline mixture is regulated under applicable EPA regulations for
fuels, fuel additives, and regulated blendstocks (40 CFR part 1090),
fuel additives, and regulated blendstocks (40 CFR part 1090),
registration of fuels and fuel additives (40 CFR part 79).
(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. 721.11859 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo- cyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-22-
150) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11860 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-alkylcarbomonocyclecarboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo- cyclic-, 2-heteroatom-substituted-4-
alkylcarbomonocyclecarboxylate (1:1) (PMN P-22-152) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). For purposes of Sec. 721.72(g)(1), this substance
may
[[Page 49796]]
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 or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11861 Sulfonium, tricarbocyclic-, salt with [polyhydro-2-
alkyl-5-(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl
polyhaloaryl ester (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo cyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-
2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester
(1:1) (PMN P-22-161) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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,
carcinogenicity, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11862 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo cyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-22-
177) 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), (3), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i)
and (ii), and (5). 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 or 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. 2024-12620 Filed 6-10-24; 8:45 am]
BILLING CODE 6560-50-P