Significant New Use Rules on Certain Chemical Substances (23-3.5e), 49770-49796 [2024-12620]
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telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
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)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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:
wysong.william@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
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SUMMARY:
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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-exportrequirements).
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
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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
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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-chemicalsunder-toxic-substances-control-act-tsca.
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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
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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
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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
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section 13 import certification
requirements. See also https://
www.epa.gov/tsca-import-exportrequirements.
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 ePMN 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-toxicsubstances-control-act-tsca.
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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-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
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
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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.
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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 nonconfidential 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:
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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, 2propenamide and salt of alkylsubstituted 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,
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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, 2oxepanone and tetrahydro-2H-pyran-2one, 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
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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-2oxocycloalkanecarboxylate (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
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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-, polyfluoropolyhydro2,2-dicarbocyclic -4,7-methano-1,3benzodioxole-5-alkanesulfonate (1:1)
(generic) (P–21–48), Sulfonium,
tricarbocyclic-, 2-[3,5bis(haloalkyl)phenyl]-.alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-2-alkyl4,7-alkano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic) (P–21–
130), Sulfonium, tricarbocyclic-, 2-(4alkoxyhalocarbomonocyclic)-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro4,7-methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic) (P–21–
131), Sulfonium,
monocarbocyclicbisarylpolyhaloalkyl,
.alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic) (P–21–
177), Sulfonium, bis(3,4polyhalocarbocyclic)aryl-, .alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro2,2-diaryl-4,7-methano-1,3heteropolycyclic-5-alkanesulfonate (1:1)
(generic) (P–21–204), and Sulfonium,
tricarbocyclic-, 2-heteroatomsubstituted-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
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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);
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• 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.
• 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 Number (Proposed CFR Citation):
P–21–55 (40 CFR 721.11838)
PMN Numbers (Proposed CFR
Citations): P–21–71 (40 CFR 721.11839)
and P–21–72 (40 CFR 721.11840)
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
Chemical Names: Poly[oxy(methyl1,2-ethandiyl)], .alpha.-(dithiocarboxy).omega.-(1-methylethoxy)-, sodium salt
(1:1) (P–21–71) and Poly[oxy(methyl1,2-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;
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• 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: 1,4Cyclohexanedicarboxylic acid, 1,4dinonyl 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
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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.
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 Number (Proposed CFR Citation):
P–21–74 (40 CFR 721.11842)
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 byproducts, 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
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
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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-
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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
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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, hydrohydroxypoly(oxyalkanediyl)and hydrohydroxypoly[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, portalof-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
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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),
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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 acrylatecontaining oil, which is subsequently
polymerized to prepare a viscosity
modifier for asphalt. Based on
analogous epoxides, EPA has identified
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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 sedimentdwelling 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
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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:
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• 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
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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: 1,3Propanediaminium, 2-hydroxyN1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3Propanediaminium, N1-hexadecyl-2-
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49779
hydroxy-N1,N1,N3,N3,N3-pentamethyl-,
chloride (1:2); 1,3-Propanediaminium,
2-hydroxy-N1,N1,N1,N3,N3pentamethyl-N3-octadecyl-, chloride
(1:2); 1,3-Propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethylN3-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
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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.
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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 1,4benzenedicarboxylic acid, 1,4- dimethyl
1,4-benzenedicarboxylate, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1′methylenebis[isocyanatobenzene]
(generic) (P–22–29), Polyester with 1,4benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1′methylenebis[4- isocyanatobenzene]
(generic) (P–22–30), and Polyester with
1,4-benzenedicarboxylic acid, 2,2dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol,
aliphatic polyester, 3-hydroxy-2,2dimethylpropyl 3-hydroxy-2,2dimethylpropanoate, 1,3isobenzofurandione 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
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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
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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
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• 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
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• 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
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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, betapolyhalopolyhydro-heteropolycyclic-5alkanesulfonate (1:1) (generic) (P–22–
150), Sulfonium, tricarbocyclic-, 2heteroatom-substituted-4alkylcarbomonocyclecarboxylate (1:1)
(generic) (P–22–152), Sulfonium,
tricarbocyclic-, salt with [polyhydro-2alkyl-5-(polyhalo-2-heteroalkyl)- alkano1,3-hetropolycyclic]alkyl polyhaloaryl
ester (1:1) (generic) (P–22–161), and
Sulfonium, tricarbocyclic-, alpha, alpha,
beta, beta-polyhalopolyhydroheteropolycyclic-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)
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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
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vapor, dust, mist, or aerosol in a nonenclosed 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/lawsregulations-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
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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
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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.
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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.
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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
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11829 through
721.11862 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
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721.11829 Unsaturated dicarboxylic acid
polymer with 2-(dialkylamino)alkylalkyl-alkanoate, N,N-dialkyl-alkene
amide, 2-propenamide and salt of alkylsubstituted 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-2oxocycloalkanecarboxylate (generic).
721.11832 Sulfonium, tricarbocyclic-,
polyfluoropolyhydro-2,2-dicarbocyclic
-4,7-methano- 1,3-benzodioxole-5alkanesulfonate (1:1) (generic).
721.11833 Sulfonium, tricarbocyclic-, 2[3,5-bis(haloalkyl)phenyl]-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro2-alkyl-4,7-alkano-1,3-heteropolycyclic5-alkanesulfonate (1:1) generic).
721.11834 Sulfonium, tricarbocyclic-, 2-(4alkoxyhalocarbomonocyclic)-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro4,7-methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic).
721.11835 Sulfonium,
monocarbocyclicbisarylpolyhaloalkyl,
.alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic).
721.11836 Sulfonium, bis(3,4polyhalocarbocyclic)aryl-, .alpha.,
.alpha., .beta, .beta.-polyhalopolyhydro2,2-diaryl-4,7-methano-1,3heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
721.11837 Sulfonium, tricarbocyclic-, 2heteroatom-substituted-4(halocarbocyclic)carboxylate (1:1)
(generic).
721.11838 Fatty acids, reaction products
with polyamine-polyacid polymer and
fatty acid (generic).
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721.11839 Poly[oxy(methyl-1,2-ethandiyl)],
.alpha.-(dithiocarboxy)-.omega.-(1methylethoxy)-, 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)ethylterminated.
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, hydrohydroxypoly(oxyalkanediyl)and hydrohydroxypoly[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, 2hydroxy-N1,N1,N1,N3,N3-pentamethylN3-tetradecyl-, chloride (1:2); 1,3Propanediaminium, N1-hexadecyl-2hydroxy-N1,N1,N3,N3,N3-pentamethyl-,
chloride (1:2); 1,3-Propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethylN3-octadecyl-, chloride (1:2); 1,3Propanediaminium, 2-hydroxyN1,N1,N1,N3,N3-pentamethyl-N3octadecen-1-yl, chloride (1:2).
721.11852 Alkanes, branched and linear
(generic).
721.11853 Polyester with 1,4benzenedicarboxylic acid, 1,4- dimethyl
1,4-benzenedicarboxylate, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1′methylenebis[isocyanatobenzene]
(generic).
721.11854 Polyester with 1,4benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3- hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1′methylenebis[4- isocyanatobenzene]
(generic).
721.11855 Polyester with 1,4benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1′-
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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, betapolyhalopolyhydro-heteropolycyclic-5alkanesulfonate (1:1) (generic).
721.11860 Sulfonium, tricarbocyclic-, 2heteroatom-substituted-4alkylcarbomonocyclecarboxylate (1:1)
(generic).
721.11861 Sulfonium, tricarbocyclic-, salt
with [polyhydro-2-alkyl-5-(polyhalo-2heteroalkyl)- alkano-1,3hetropolycyclic]alkyl polyhaloaryl ester
(1:1) (generic).
721.11862 Sulfonium, tricarbocyclic-,
alpha, alpha, beta, betapolyhalopolyhydro-heteropolycyclic-5alkanesulfonate (1:1) (generic).
*
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*
*
§ 721.11829 Unsaturated dicarboxylic acid
polymer with 2-(dialkylamino)alkyl-alkylalkanoate, N,N-dialkyl-alkene amide, 2propenamide 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, 2propenamide and salt of alkylsubstituted 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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
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substance may cause: skin corrosion and
eye irritation. For purposes of
§ 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 § 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
§ 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 § 721.185 apply to this
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§ 721.11830 Octadecanoic acid, 12hydroxy-, polymer with aziridine, 2oxepanone 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, 12hydroxy-, polymer with aziridine, 2oxepanone and tetrahydro-2H-pyran-2one, 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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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 § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
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(NIOSH) assigned protection factor
(APF) of at least 50 during non-spray
applications or 10,000 during spray
applications. For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: skin irritation, eye
irritation, and specific target organ
toxicity. For purposes of § 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 § 721.80(o).
(iv) Release to water. Requirements as
specified in § 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
§ 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 § 721.185 apply to this
section.
§ 721.11831 Ethyl 4-alkyl-2oxocycloalkanecarboxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethyl 4-alkyl-2oxocycloalkanecarboxylate (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
§ 721.63(a)(1) and (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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
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of § 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: specific target
organ toxicity. For purposes of
§ 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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11832 Sulfonium, tricarbocyclic-,
polyfluoropolyhydro-2,2-dicarbocyclic -4,7methano- 1,3-benzodioxole-5alkanesulfonate (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-5alkanesulfonate (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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1), engineering
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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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 721.11833 Sulfonium, tricarbocyclic-, 2[3,5-bis(haloalkyl)phenyl]-.alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-2-alkyl-4,7alkano-1,3-heteropolycyclic-5alkanesulfonate (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.-polyhalopolyhydro2-alkyl-4,7-alkano-1,3-heteropolycyclic5-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
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used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
§ 721.11834 Sulfonium, tricarbocyclic-, 2(4-alkoxyhalocarbomonocyclic)-.alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-4,7methano-1,3-heteropolycyclic-5alkanesulfonate (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-1,3heteropolycyclic-5-alkanesulfonate (1:1)
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Sfmt 4702
(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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
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khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 721.11835 Sulfonium,
monocarbocyclicbisarylpolyhaloalkyl,
.alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano1,3-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-4,7methano-1,3-heteropolycyclic-5alkanesulfonate (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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
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18:05 Jun 10, 2024
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apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
§ 721.11836 Sulfonium, bis(3,4polyhalocarbocyclic)aryl-, .alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-2,2-diaryl4,7-methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, bis(3,4polyhalocarbocyclic)aryl-, .alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro2,2-diaryl-4,7-methano-1,3heteropolycyclic-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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 721.80(f), (k), and (t). It is
a significant new use to import the
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49787
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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
§ 721.11837 Sulfonium, tricarbocyclic-, 2heteroatom-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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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
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System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), and (5). For purposes
of § 721.72(e), the concentration is set at
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1.0%. For purposes of § 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
§ 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 § 721.185 apply to this
section.
§ 721.11839 Poly[oxy(methyl-1,2ethandiyl)], .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.-(1methylethoxy)-, 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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For the
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause skin irritation, eye
irritation, reproductive toxicity, and
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specific target organ toxicity. For
purposes of § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11840 Poly[oxy(methyl-1,2ethandiyl)], .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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
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through (f), (g)(1), (3), and (5). For the
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause skin irritation, eye
irritation, reproductive toxicity, and
specific target organ toxicity. For
purposes of § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
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§ 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, 1,4dinonyl 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
§ 721.63(a)(1), (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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
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of § 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For the
purposes of § 721.72(e) the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: reproductive
toxicity and specific target organ
toxicity. For the purposes of
§ 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11842 1,3-Butadiene, homopolymer,
hydrogenated, 2-(ethenyloxy)ethylterminated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-butadiene, homopolymer,
hydrogenated, 2-(ethenyloxy)ethylterminated (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
§ 721.63(a)(1), (3), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
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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 § 721.72(a)
through (d), (f), (g)(1), and (5). For
purposes of § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
§ 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 § 721.72(a)
through (f), (g)(1), (3), and (5). For the
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause specific target
organ toxicity. For purposes of
§ 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.
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(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 § 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
§ 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 § 721.185 apply to this
section.
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§ 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
§ 721.63(a)(1) and (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), and (g)(1), (3) and (5). For
the purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause specific target
organ toxicity. For purposes of
§ 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
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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 § 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
§ 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 § 721.185 apply to this
section.
§ 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 5sulfobicyclo[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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 721.72(g)(1), this substance may
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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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11846 Triazine-trione,
tris(isocyanatoalkyl)-, polymer with
substituted diisocyanato
alkylcarbomonocycle, hydrohydroxypoly(oxyalkanediyl) and hydrohydroxypoly[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, hydrohydroxypoly(oxyalkanediyl) and hydrohydroxypoly[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
§ 721.63(a)(1) and (3), and (c). When
determining which persons are
reasonably likely to be exposed as
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required for § 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 § 721.72(a)
through (d), (f), and (g)(1), (3) and (5).
For purposes of § 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 § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 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 § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), and (5). For the
purposes of § 721.72(e) the
concentration is set at 1.0%. For
purposes of § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11847
§ 721.11848
epoxidized.
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
§ 721.63(a)(1), (3) through (5), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 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)
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Soybean oil, oleic acid-high,
(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
§ 721.63(a)(1) and (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
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control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. For purposes
of § 721.63(b), the concentration is set at
0.1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For
purposes of § 721.72(e), the
concentration is set at 0.1%. For
purposes of § 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
§ 721.11849 Sulfonium,
(halocarbomonocycle)diphenyl-, salt with 1heterosubstituted-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
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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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
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§ 721.11850
(generic).
1,6-Disubstituted hexane
(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
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substance after they have been reacted
or destroyed.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) and (3), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (3), and (5). For
purposes of § 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
§ 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 § 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 § 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
§ 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 § 721.185 apply to this
section.
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§ 721.11851 1,3-Propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3Propanediaminium, N1-hexadecyl-2hydroxy-N1,N1,N3,N3,N3-pentamethyl-,
chloride (1:2); 1,3-Propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3octadecyl-, chloride (1:2); 1,3Propanediaminium, 2-hydroxyN1,N1,N1,N3,N3-pentamethyl-N3-octadecen1-yl, chloride (1:2).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-propanediaminium, 2-hydroxyN1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3propanediaminium, N1-hexadecyl-2hydroxy-N1,N1,N3,N3,N3-pentamethyl-,
chloride (1:2); 1,3-propanediaminium,
2-hydroxy-N1,N1,N1,N3,N3pentamethyl-N3-octadecyl-, chloride
(1:2); 1,3-propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethylN3-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
§ 721.63(a)(1) and (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.63(b), the concentration is set at
0.1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (3), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 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 § 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 § 721.80(o). It is a
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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 § 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
§ 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 § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 721.11852
(generic).
Alkanes, branched and linear
(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
§ 721.63(a)(1) and (3), (b) and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.63(b), the concentration is set at
0.1%.
(ii) Hazard communication.
Requirements as specified in
§ 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
§ 721.125(a) through (i), are applicable
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to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11853 Polyester with 1,4benzenedicarboxylic acid, 1,4- dimethyl 1,4benzenedicarboxylate, 2,2-dimethyl-1,3propanediol, dodecanedioic acid, 1,2ethanediol, aliphatic polyester, 3- hydroxy2,2-dimethylpropyl 3-hydroxy-2,2dimethylpropanoate, 1,3isobenzofurandione 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 1,4benzenedicarboxylic acid, 1,4- dimethyl
1,4-benzenedicarboxylate, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione 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
§ 721.63(a)(1) and (3), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), and (5). For
purposes of § 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 § 721.80(o). It is a
significant new use to manufacture,
process, or use the substance in any
manner that results in inhalation
exposure.
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49793
(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
§ 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 § 721.185 apply to this
section.
§ 721.11854 Polyester with 1,4benzenedicarboxylic acid, 2,2-dimethyl-1,3propanediol, dodecanedioic acid, 1,2ethanediol, aliphatic polyester, 3-hydroxy2,2-dimethylpropyl 3- hydroxy-2,2dimethylpropanoate, 1,3isobenzofurandione 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 1,4benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3isobenzofurandione 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
§ 721.63(a)(1) and (3), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), and (5). For
purposes of § 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 § 721.80(o). It is a
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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
§ 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 § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 721.11855 Polyester with 1,4benzenedicarboxylic acid, 2,2-dimethyl-1,3propanediol, dodecanedioic acid, 1,2ethanediol, aliphatic polyester, 3-hydroxy2,2-dimethylpropyl 3-hydroxy-2,2dimethylpropanoate, 1,3isobenzofurandione 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 1,4benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid,
1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy2,2-dimethylpropanoate, 1,3isobenzofurandione 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
§ 721.63(a)(1) and (3), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), and (5). For
purposes of § 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
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Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 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
§ 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 § 721.185 apply to this
section.
§ 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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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
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Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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
§ 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 § 721.185 apply to this
section.
§ 721.11857
(generic).
Fluoroheteroacid, metal salt
(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
§ 721.63(a)(1), (3) through (5), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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 § 721.72(a)
through (d), (f), (g)(1), (3), and (5). For
purposes of § 721.72(g)(1), this
substance may cause: acute toxicity,
skin corrosion, serious eye damage, skin
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sensitization, reproductive toxicity, and
specific target organ toxicity. For
purposes of § 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 § 721.80(o).
(iv) Release to water. Requirements as
specified in § 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
§ 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 § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 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
§ 721.63(a)(1) and (3), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.63(b), the concentration is set at
0.1%.
(ii) Hazard communication.
Requirements as specified in
§ 721.72(a).
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 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
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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
§ 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 § 721.185 apply to this
section.
§ 721.11859 Sulfonium, tricarbocyclic-,
alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, tricarbocyclic-, alpha, alpha, beta, betapolyhalopolyhydro-heteropolycyclic-5alkanesulfonate (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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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
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Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
§ 721.11860 Sulfonium, tricarbocyclic-, 2heteroatom-substituted-4alkylcarbomonocyclecarboxylate (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-4alkylcarbomonocyclecarboxylate (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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 721.72(g)(1), this substance may
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required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed process. It is a significant new
use to manufacture the substance longer
than 9 months.
§ 721.11861 Sulfonium, tricarbocyclic-, salt
(b) Specific requirements. The
with [polyhydro-2-alkyl-5-(polyhalo-2provisions
of subpart A of this part
heteroalkyl)- alkano-1,3-hetropolycyclic]
apply to this section except as modified
alkyl polyhaloaryl ester (1:1) (generic).
by this paragraph (b).
(a) Chemical substance and
(1) Recordkeeping. Recordkeeping
significant new uses subject to reporting.
requirements as specified in
(1) The chemical substance identified
§ 721.125(a) through (i) are applicable to
generically as sulfonium, tricarbo
manufacturers, importers, and
cyclic-, salt with [polyhydro-2-alkyl-5processors of this substance.
(polyhalo-2-heteroalkyl)- alkano-1,3(2) Limitation or revocation of certain
hetropolycyclic]alkyl polyhaloaryl ester
notification requirements. The
(1:1) (PMN P–22–161) is subject to
provisions of § 721.185 apply to this
reporting under this section for the
section.
significant new uses described in
paragraph (a)(2) of this section. The
§ 721.11862 Sulfonium, tricarbocyclic-,
alpha, alpha, beta, beta-polyhalopolyhydrorequirements of this section do not
apply to quantities of the substance after heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
they have been completely reacted or
(a) Chemical substance and
adhered (during photolithographic
significant new uses subject to reporting.
processes) onto a semiconductor wafer
(1) The chemical substance identified
surface or similar manufactured article
generically as sulfonium, tricarbo
used in the production of
cyclic-, alpha, alpha, beta, betasemiconductor technologies.
polyhalopolyhydro-heteropolycyclic-5(2) The significant new uses are:
(i) Protection in the workplace.
alkanesulfonate (1:1) (PMN P–22–177) is
Requirements as specified in
subject to reporting under this section
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c). for the significant new uses described in
When determining which persons are
paragraph (a)(2) of this section. The
reasonably likely to be exposed as
requirements of this section do not
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
VerDate Sep<11>2014
18:05 Jun 10, 2024
Jkt 262001
PO 00000
Frm 00028
Fmt 4701
Sfmt 9990
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
§ 721.63(a)(1), (2)(i) and (iii), (3), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (iii),
(v), (3)(i) and (ii), and (5). For purposes
of § 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 § 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 nonenclosed 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
§ 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 § 721.185 apply to this
section.
[FR Doc. 2024–12620 Filed 6–10–24; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\11JNP2.SGM
11JNP2
]]>Agencies
[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
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 49772]]
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
