[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Rules and Regulations]
[Pages 33283-33299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13363]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0079; FRL-12386-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
3.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs) and are also
subject to an Order issued by EPA pursuant to TSCA. The SNURs require
persons to notify EPA at least 90 days before commencing the
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 in the SNUR. The required notification initiates
EPA's evaluation of the conditions of that use for that chemical
substance. In addition, the manufacture or processing for the
significant new use may not commence until EPA has conducted a review
of the required notification; made an appropriate determination
regarding that notification; and taken such actions as required by that
determination.
DATES: This rule is effective on September 15, 2025. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on July
31, 2025.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2024-0079, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jordan Garbin, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-4156; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information on TSCA: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2).
B. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical
substances identified in this document. These chemical substances were
the
[[Page 33284]]
subject of PMNs and are also subject to an Order issued by EPA pursuant
to TSCA section 5(e)(1)(A), as required by the determinations made
under TSCA section 5(a)(3)(B). The 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). The SNURs
require persons who intend to manufacture or process any of these
chemical substances for an activity that is designated as a significant
new use in the SNURs to notify EPA at least 90 days before commencing
that activity.
Previously, EPA proposed SNURs for these chemical substances in the
Federal Register of December 17, 2024 (89 FR 102046 (FRL-12386-01-
OCSPP)). The docket includes information considered by the Agency in
developing the proposed and final rules, including public comments and
EPA's responses to the comments received as discussed in Unit II.D.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in this document. The following list of
North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40
CFR part 707, subpart B. Importers of chemical substances in bulk form,
as part of a mixture, or as part of an article (if required by rule)
must certify that the shipment of the chemical substance complies with
all applicable rules and orders under TSCA, including regulations
issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance identified in this document 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 SNUN
reporting requirements for potential manufacturers and processors of
the chemical substances identified in this document. This analysis,
which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN. 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)). 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 pre-
existing export notification requirements under TSCA section 12(b) and
the implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
II. Background
A. General Information About SNURs
Unit II. of the proposed rule provides general information about
SNURs, and additional information about EPA's new chemical program is
available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
B. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA
concluded that the proposed significant new uses were not ongoing. If
EPA subsequently determines that such a use was ongoing as of the date
of publication of the proposed rule and did not cease prior to issuance
of the final rule, EPA will not designate that use as a significant new
use in the final rule. EPA has no information to suggest that any of
the significant new uses identified in this rule meet this criterion.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B)
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. The objective of EPA's approach is to
ensure that a person cannot impede finalization of a SNUR by initiating
a significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
In the unlikely event that before a final rule becomes effective a
person begins commercial manufacturing (including importing) or
processing of the chemical substances for a use that is designated as a
significant new use in that final rule, such a person 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 wait until all TSCA
[[Page 33285]]
prerequisites for the commencement of manufacture or processing have
been satisfied.
Issuance of a 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 on the internet at
https://www.epa.gov/tsca-inventory.
C. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, TSCA order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to or reasonably ascertainable by
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the
Agency has the authority to require appropriate testing. To assist with
EPA's analysis of the SNUN, submitters are encouraged, but not
required, to provide the potentially useful information as identified
for the chemical substance in Unit III.C. of the proposed rule.
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. of the
proposed rule may not be the only means of providing information to
evaluate the chemical substance associated with the significant new
uses. However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA sections 5(e) or 5(f).
EPA recommends that potential SNUN submitters contact EPA early enough
so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
D. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed SNURs and prepared a
Response to Comment document that provides the Agency responses. The
comments and the Response to Comment document are available in the
docket. As described in the Response to Comment document, EPA is
finalizing these SNURs with the following changes (listed by PMN Number
and proposed 40 CFR citation):
For P-23-37 (40 CFR 721.12069), P-23-44 (40 CFR
721.12070), P-23-80 (40 CFR 721.12071), P-23-93 (40 CFR 721.12072), and
P-23-172 (40 CFR 721.12076), EPA incorporated the requirements of 40
CFR 721.72(e) to include a de minimis provision of 1.0% for consistency
with the underlying Orders for these substances. EPA also corrected the
significant new use regarding the manner in which the substance is
imported. The significant new use now reads ``It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less.''
In addition to the changes to respond to comments, EPA identified
the need to revise the following proposed SNURs (listed by PMN Number
and proposed 40 CFR citation):
For P-21-170 (40 CFR 721.12048), EPA addressed an
inadvertent omission in the industrial, commercial, and consumer
activities paragraph of the regulatory text by including processing for
use or use of the substance where the concentration of the substance in
the final product exceeds 0.008% as a significant new use. In the
Federal Register of December 17, 2024 (89 FR 102051), EPA proposed to
designate this use as a significant new use, but inadvertently omitted
it from the proposed regulatory text appearing on page 102064.
For P-21-170 (40 CFR 721.12048), P-22-58 (40 CFR
721.12058), P-22-75 (40 CFR 721.12059), P-22-78 (40 CFR 721.12060), P-
23-36 (40 CFR 721.12068), and P-23-64 (40 CFR 721.12073), EPA made
minor edits to the language in the industrial, commercial, and consumer
activities paragraph to be consistent with previous SNURs that had
similar requirements.
For P-18-325 (40 CFR 721.12044), P-21-170 (40 CFR
721.12048), P-21-184 (40 CFR 721.12049), P-22-25 (40 CFR 721.12055), P-
22-58 (40 CFR 721.12058), P-22-75 (40 CFR 721.12059), P-22-78 (40 CFR
721.12060), and P-22-82 (40 CFR 721.12062) EPA simplified the
requirements in the industrial, commercial, and consumer activities
paragraph by removing inadvertent duplication of certain significant
new uses.
For P-18-127 (40 CFR 721.12043), P-18-325 (40 CFR
721.12044), P-20-14 (40 CFR 721.12045), P-21-164 (40 CFR 721.12047), P-
21-170 (40 CFR 721.12048), P-21-184 (40 CFR 721.12049), P-22-3 (40 CFR
721.12050), P-22-4 (40 CFR 721.12051), P-22-5 (40 CFR 721.12052), P-22-
6 (40 CFR 721.12053), P-22-49 (40 CFR 721.12056). P-22-50 (40 CFR
721.12057), P-22-58 (40 CFR 721.12058), P-22-75 (40 CFR 721.12059), P-
22-78 (40 CFR 721.12060), P-22-80 (40 CFR 721.12061), P-22-121 (40 CFR
721.12063), P-22-145 (40 CFR 721.12064), P-22-175 (40 CFR 721.12065),
P-22-30 (40 CFR 721.12067), P-23-36 (40 CFR 721.12068), and P-23-72 (40
CFR 721.12074), EPA simplified the requirements in the hazard
communication paragraph by referencing 40 CFR 721.72(g)(3)(iii) rather
than referencing 721.72(g)(3) and writing out the required
environmental hazard statement.
For P-22-3 (40 CFR 721.12050), P-22-4 (40 CFR 721.12051),
P-22-5 (40 CFR 721.12052), and P-22-6 (40 CFR
[[Page 33286]]
721.12053), EPA modified the language in the release to water paragraph
to be consistent with previous SNURs that had similar requirements.
For P-22-58 (40 CFR 721.12058) and P-23-36 (40 CFR
721.12068), EPA made minor changes to the language in the industrial,
commercial, and consumer activities paragraph to more closely align the
significant new uses with the terms of the underlying TSCA Orders for
these substances.
For P-22-121 (40 CFR 721.12063) and P-22-175 (40 CFR
721.12065), EPA replaced the generic chemical name with the specific
chemical name and CASRN because the CBI claim for this information has
been relinquished by the PMN submitter.
For P-23-72 (40 CFR 721.12074), EPA modified the language
in the industrial, commercial, and consumer activities paragraph to
clarify that ``40% by weight'' is referring to the concentration of the
substance in the final formulation.
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing, i.e.,
December 17, 2024 (89 FR 102046 (FRL-12386-01-OCSPP)). This designation
is explained in more detail in Unit II.B.
B. What information was provided for each chemical substance?
In Unit III.C. of the proposed rule, EPA provided the following
information for each chemical substance subject to these SNURs:
PMN number (the 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) or
Accession Number (if assigned, for confidential chemical identities).
Basis for the SNUR (e.g., effective date of and basis for
the TSCA Order).
Potentially useful information.
The regulatory text section of this document specifies the chemical
substances and activities designated as significant new uses. Certain
new uses, including production volume limits and other uses designated,
may be claimed as CBI, as discussed in more detail in Unit II.C. of the
proposed rule.
In addition, as discussed in Unit III.B. of the proposed rule,
these SNURs include PMN substances that are subject to orders issued
under TSCA section 5(e)(1)(A), as required by the determinations made
under TSCA section 5(a)(3)(B). Those TSCA Orders require protective
measures to limit exposures or otherwise mitigate the potential
unreasonable risk. As such, the 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).
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action establishes SNURs for new chemical substances that were
the subject of PMNs. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order 12866
(58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because a significant new use rule for a new chemical under TSCA
section 5 is exempt from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in
FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction
of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-
5597-1)), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or
[[Page 33287]]
uniquely affect small governments. Based on EPA's experience with
proposing and finalizing SNURs, State, local, and Tribal governments
have not been impacted by SNURs, and EPA does not have any reasons to
believe that any State, local, or Tribal government will be impacted by
these SNURs. In addition, the estimated costs of this action to the
private sector do not exceed $183 million or more in any one year (the
1995 dollars are adjusted to 2023 dollars for inflation using the GDP
implicit price deflator). The estimated costs for this action are
discussed in Unit I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the intended uses to identify potential risks and
take appropriate actions before the activities commence.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 14, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, 40 CFR chapter I is amended
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. 721.12043 through 721.12076 to Subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.12043 Heptane, 2-methoxy-2-methyl-.
721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-
propanol] (1:1) (generic).
721.12045 Sugars, polymer with alkanetriamine (generic).
721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
721.12047 2-Butanone, oxime, reaction products with
trimethoxymethylsilane.
721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
721.12049 Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
721.12052 Formic acid, compd. with 2-methyl-1,5- pentanediamine
(2:1).
721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine
(1:1).
721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-
oxo-2-propen-1-yl)oxylethyl]carbamates] (generic).
721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with
dialkyl-alkanediol (2:1) (generic).
721.12056 Aryl, polymer with formaldehyde, glycidyl ether, reaction
products with amino alkyl-alkane diamine, cyclohexanediamine and
alkylene (alkylcyclohexanamine) (generic).
721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
721.12058 Methanesulfonamide, l,l,l-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
721.12059 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-.
721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl
ethers, phosphates, salt (generic).
721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-
(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-
(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)-.
721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer
with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
721.12063 1-Propene, 1,1,3,3-tetrachloro-.
721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle
bis(alkyleneoxy)]bis[alkanediol] (generic).
721.12065 Silsesquioxanes, Me vinyl, hydroxy and methoxy and
[(trimethylsilyl)oxy]- terminated.
721.12066 Vegetable oil, polymer with pimelin ketone, oxymethylene
and polymethylenepolyphenylene isocyanate (generic).
721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with silicic
acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
721.12068 Castor oil, polymer with dicyclopentadiene, maleic
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(generic).
[[Page 33288]]
721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle
sulfonic acid salt (generic).
721.12073 Alkanediol, substituted, polymer with diisocyanatoalkane,
substituted heterocycle-modified (generic).
721.12074 Halosubstituted carbopolycycle, polymer with substituted
carbomonocycles and oxybis[alkanol] (generic).
721.12075 Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and
triisocyanate (generic).
721.12076 Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
* * * * *
Sec. 721.12043 Heptane, 2-methoxy-2-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as heptane, 2-methoxy-
2-methyl- (PMN P-18-127; CASRN 76589-16-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
sensitization and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance unless by import into the United States in a
solution of no greater than 5% by weight (i.e., no domestic
manufacture). It is a significant new use to process the substance
unless in a solution of no greater than 5% by weight of the substance.
It is a significant new use to process for use or use the substance in
consumer products unless the concentration of the substance is less
than 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=210.
(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. 721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-
iminobis[2-propanol] (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol]
(1:1) (PMN P-18-325) 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), (g)(3)(iii) and (g)(5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to the substance. It is
a significant new use to process for use or use the substance other
than as an industrial cross-linking catalyst.
(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. 721.12045 Sugars, polymer with alkanetriamine (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as sugars,
polymer with alkanetriamine (PMN P-20-14) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=191.
(b) Specific requirements. The provisions of Subpart A of this part
[[Page 33289]]
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. 721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as isooctadecanamide,
N,N-bis(2-ethylhexyl)- (PMN P-21-86; CASRN 1616494-50-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in a polymer.
(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), 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.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance for use in a consumer
product where the concentration of the substance in the consumer
product formulation exceeds the confidential percentage listed in the
Order. It is a significant new use to use the substance in a consumer
product where the concentration of the substance exceeds the
confidential percentage listed in the Order.
(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. 721.12047 2-Butanone, oxime, reaction products with
trimethoxymethylsilane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-butanone, oxime,
reaction products with trimethoxymethylsilane (PMN P-21-164; CASRN
2639393-45-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, carcinogenicity, serious eye damage, reproductive toxicity,
skin irritation, skin sensitization, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to load or unload the substance for manufacture,
processing, or use in any manner unless under a gas (e.g., nitrogen)
blanket. It is a significant new use to use the substance unless at 4%
or less by weight in formulation. It is a significant new use to apply
the substance for use unless by roll, brush, or dip coating.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,6-
bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-
cycloalkyladien-1-one (generic) (PMN P-21-170) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, skin sensitization, genetic
toxicity, carcinogenicity, reproductive toxicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance
[[Page 33290]]
beyond an annual production volume of 10 kilograms. It is a significant
new use to process for use or use the substance other than as a color
indicator for frying oil breakdown. It is a significant new use to
process for use or use the substance where the concentration of the
substance in the final product exceeds 0.008%. It is a significant new
use to manufacture, process, or use the substance in any manner that
results in the release of the substance to air except with the use of a
HEPA filtration system.
(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. 721.12049 Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids, soya,
reaction products with ammonia-ethanolamine reaction by-products (PMN
P-21-184; CASRN 2378512-59-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, skin irritation, serious eye damage, eye
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in the generation of vapor, mist, aerosol, or dust.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,5-pentanediamine,
2-methyl-, hydrochloride (1:2) (PMN P-22-3; CASRN 34813-63-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, and eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 in aggregate of P-22-3,
P-22-4, P-22-5, and P-22-6.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,5-pentanediamine,
2-methyl-, hydrochloride (1:1) (PMN P-22-4; CASRN 1840915-04-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, serious eye damage, skin corrosion, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any
[[Page 33291]]
manner that results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 in aggregate of P-22-3,
P-22-4, P-22-5, and P-22-6.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12052 Formic acid, compd. with 2-methyl-1,5-pentanediamine
(2:1).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as formic acid, compd. with
2-methyl-1,5-pentanediamine (2:1) (PMN P-22-5; CASRN 1836131-73-7) 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), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 in aggregate of P-22-3,
P-22-4, P-22-5, and P-22-6.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine
(1:1)
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as formic acid, compd. with
2-methyl-1,5-pentanediamine (1:1) (PMN P-22-6; CASRN 1836131-75-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, skin irritation, serious eye damage, eye irritation, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=570 in aggregate of P-22-3,
P-22-4, P-22-5, and P-22-6.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-
[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-
1- yl)oxylethyl]carbamates] (PMN P-22-11) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, respiratory
sensitization, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in
[[Page 33292]]
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. 721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with
dialkyl-alkanediol (2:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, 2-(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol
(2:1) (PMN P-22-25) 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), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, genetic toxicity, carcinogenicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (t). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing 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. 721.12056 Aryl, polymer with formaldehyde, glycidyl ether,
reaction products with amino alkyl-alkane diamine, cyclohexanediamine
and alkylene (alkylcyclohexanamine) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as aryl,
polymer with formaldehyde, glycidyl ether, reaction products with amino
alkyl-alkane diamine, cyclohexanediamine and alkylene
(alkylcyclohexanamine) (PMN P-22-49) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, skin corrosion, serious eye
damage, respiratory sensitization, skin sensitization, genetic
toxicity, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. 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=2.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as alkene,
alkoxy-, polymer with alkoxyalkene (PMN P-22-50) 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 (a)(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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
[[Page 33293]]
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. 721.12058 Methanesulfonamide, l,l,l-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Methanesulfonamide,
l,l,l-trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1) (PMN
P-22-58; CASRN 91742-21-1) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, serious
eye damage, skin irritation, reproductive toxicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(b) and (k). It is a significant new use to
process the substance in any manner that generates a vapor, mist,
aerosol, or dust that results in inhalation to workers. It is a
significant new use to use the substance in an application method that
generates a vapor, mist, aerosol, or dust that results in inhalation to
workers. It is a significant new use to use the substance other than in
the form of a liquid.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=100.
(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. 721.12059 H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-isoindole-
1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- (PMN P-22-75;
CASRN 15458-48-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) 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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance beyond an annual production volume of 3,000
kilograms. It is a significant new use to use the substance other than
as a monomer used to produce an unsaturated polyester resin.
(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. 721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-
isoalkyl ethers, phosphates, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl ethers,
phosphates, salt (PMN P-22-78) 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), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that generates a vapor, mist, aerosol, or dust. It is a
[[Page 33294]]
significant new use to process for use or use the substance other than
as a dispersing agent for pesticide formulations.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=23.
(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. 721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-
aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl),
.alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and
poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-(iminodi-2,1-
ethanediyl)bis[.omega.-(2-aminoethoxy)- (PMN P-22-80; CAS Nos. 24991-
53-5 and 90350-34-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or 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), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, and skin sensitization.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.7.
(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. 721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester,
polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer with trihalo
(trihaloalkyl) alkyl alkyl alkenoate (PMN P-22-82) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in dried photoresist.
(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), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (v)(1), (2) and (4), (w)(1), (2) and
(4), and (x)(1), (2) and (4). It is a significant new use to
manufacture the substance other than by import into the United States
(i.e., no domestic manufacture) in a liquid formulation.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12063 1-Propene, 1,1,3,3-tetrachloro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propene, 1,1,3,3-
tetrachloro- (PMN P-22-121; CASRN 18611-43-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, carcinogenicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the
[[Page 33295]]
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 (k). It is a significant new use to
process, use, load, or unload the substance unless under a gas (e.g.,
nitrogen) blanket or in a closed system except that sampling may occur
outside the closed system resulting in exposures.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.15.
(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. 721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle
bis(alkyleneoxy)]bis[alkanediol] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, trialkyl-, diester with carbomonocycle
bis(alkyleneoxy)]bis[alkanediol] (PMN P-22-145) 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), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: acute toxicity,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in any manner that may generate a spray, mist, vapor, or
aerosol containing the substance unless the concentration of the
substance is less than 5.7% by weight.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12065 Silsesquioxanes, Me vinyl, hydroxy and methoxy and
[(trimethylsilyl)oxy]-terminated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silsesquioxanes, Me
vinyl, hydroxy and methoxy and [(trimethylsilyl)oxy]- terminated (PMN
P-22-175; CASRN 2450324-50-0) 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), (a)(3) through (6), (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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance unless the concentration of the substance does not exceed 10%
by weight in formulation.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=7.
(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. 721.12066 Vegetable oil, polymer with pimelin ketone,
oxymethylene and polymethylenepolyphenylene isocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with pimelin ketone, oxymethylene and
polymethylenepolyphenylene isocyanate (PMN P-23-18) 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 (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity,
[[Page 33296]]
skin irritation, eye irritation, respiratory sensitization, skin
sensitization, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with
silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silsesquioxanes, 3-
mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester,
[(trimethylsilyl)oxy]-terminated (PMN P-23-20; CASRN 2796383-42-9) 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), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
sensitization and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12068 Castor oil, polymer with dicyclopentadiene, maleic
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as castor oil, polymer
with dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol,
3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and
triethylene glycol (PMN P-23-36; CASRN 2794200-69-2) 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) 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), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, aerosol, or dust.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=27.
(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. 721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt
(PMN P-23-37) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii)
[[Page 33297]]
and (v), (g)(3)(i) and (ii), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, skin sensitization, genetic toxicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of 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. 721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt
(PMN P-23-44) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, reproductive toxicity, skin sensitization, genetic toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of 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. 721.12071 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-23-
80) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or adhered (during photolithographic
processes) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of 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. 721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle
sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid
salt (PMN P-23-93) 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
[[Page 33298]]
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, reproductive toxicity, skin sensitization, genetic toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing or use of 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. 721.12073 Alkanediol, substituted, polymer with
diisocyanatoalkane, substituted heterocycle-modified (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediol, substituted, polymer with diisocyanatoalkane, substituted
heterocycle-modified (PMN P-23-64) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance 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 (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), and (y)(1) and (2). It is a
significant new use to manufacture or process the substance in any
manner that generates a vapor, mist, aerosol, or dust.
(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. 721.12074 Halosubstituted carbopolycycle, polymer with
substituted carbomonocycles and oxybis[alkanol] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halosubstituted carbopolycycle, polymer with substituted
carbomonocycles and oxybis[alkanol] (PMN P-23-72) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), (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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 0.1%. For purposes of
Sec. 721.72(g)(1), this substance may cause: genetic toxicity,
carcinogenicity, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
for use or use the substance other than in an enclosed roll-coating
lithographic printing machine. It is a significant new use to process
for use or use the substance at a concentration in the final
formulation that exceeds 40% by weight for a coating application.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(2),
(b)(2), and (c)(2).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 33299]]
Sec. 721.12075 Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and
triisocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polymer
of benzenedicarboxylic acid, substituted-benzenedicarboxylic acid,
branched-alkyldiol, alkyldiol and triisocyanate (PMN P-23-94) 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 (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, respiratory
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
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. 721.12076 Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, alkylcarbomonocyclic-polyfluoro-
heteropolycyclic-alkyl sulfonate (1:1), polymer with alkylaryl and
carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
alkylalkanoate]-initiated (PMN P-23-172) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
adhered (during photolithographic processes) onto a semiconductor wafer
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of Subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
* * * * *
[FR Doc. 2025-13363 Filed 7-16-25; 8:45 am]
BILLING CODE 6560-50-P