[Federal Register Volume 90, Number 211 (Tuesday, November 4, 2025)]
[Rules and Regulations]
[Pages 49218-49234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19773]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0332; FRL-12563-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
4.5e)
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 January 5, 2026. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EDT) on
November 18, 2025.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2024-0332, 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: Ira L. Lyons, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1481; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental
[[Page 49219]]
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information on TSCA: The TSCA Assistance Information
Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-
1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2).
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 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 April 4, 2025 (90 FR 14743 (FRL-12563-01-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, i.e., 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
[[Page 49220]]
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
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-24-42 (40 CFR 721.12110), EPA added ``respiratory
sensitization'' to the list of required human health hazards statements
in the hazard communication paragraph to correct an omission in the
proposed SNUR.
In addition to the change to respond to a comment, EPA identified
the need to revise the following proposed SNURs (listed by PMN Number
and proposed 40 CFR citation):
For P-22-155 (40 CFR 721.12098) and P-22-157 (40 CFR
721.12099), 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-22-83 (40 CFR 721.12085), EPA modified the release
to water requirements to reflect a provision in the Order allowing
wastewater treatment to be considered when computing estimated surface
water concentrations to correct an omission in the proposed SNUR.
For P-22-154 (40 CFR 721.12097), 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-18-360 (40 CFR 721.12077), P-20-87 (40 CFR
721.12078), P-22-83 (40 CFR 721.12085), P-22-89 (40 CFR 721.12086), P-
22-91 (40 CFR 721.12088), P-22-130 (40 CFR 721.12090), P-22-131 (40 CFR
721.12091), P-22-132 (40 CFR 721.12092), P-22-133 (40 CFR 721.12093),
P-22-134 (40 CFR 721.12094), P-22-135 (40 CFR 721.12095), P-22-139 (40
CFR 721.12096), P-22-155 (40 CFR 721.12098), P-22-157 (40 CFR
721.12099), and P-23-126 (40 CFR 72.12107), EPA added a reference to
paragraph 721.63(a)(6) in the requirements for protection in the
workplace to correct an omission in these proposed SNURs.
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., April
4, 2025
[[Page 49221]]
(90 FR 14743 (FRL-12563-01-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 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
[[Page 49222]]
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: October 28, 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. 721.12077 through 721.12111 to subpart E to read as
follows:
* * * * *
Sec.
721.12077 Oxirane, 2-methyl-, polymer with 2,4-diisocyanato-1-
methylbenzene, 2-methyloxirane polymer with oxirane ether with
1,2,3-propanetriol (3:1), and oxirane, cashew nutshell liq.- and Pr
alc. -blocked.
721.12078 Alcohols, C8-10-iso-, C9-rich, ethoxylated.
721.12079 Reaction product of polyester with .alpha.-hydro-.omega.-
hydroxypoly (oxy-1,4- butanediyl) and 1,1'-
methylenebis[isocyanatobenzene] (generic).
721.12080 Benzene, [2-[(2-methyl-1-undecen-1-yl) oxy]ethyl]-.
721.12081 Siloxanes and Silicones, alkyl methyl, dimethyl (generic).
721.12082 Protein sodium complexes, polymers with aromatic acid
chloride, ethylene diamine and amino acid (generic).
721.12083 Aryl-substituted-heterocyclic-polyamine, reaction products
with polyethylene glycol alkyl-ether, and nitrogen and alkyl-
substituted benzene (generic).
721.12084 Thermomycolin, Malbranchea cinnamomea origin, expressed in
genetically modified Trichoderma reesei.
721.12085 Oils, sandalwood, santalene synthase-modified Rhodobacter
sphaeroides-fermented, from D-Glucose, oxidized.
721.12086 Carboxylic acid substituted carbomonocycles, polymer with
dialkyl-alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl)
oxy]alkyl ester (generic).
721.12087 4,8,11-Dodecatrienal.
721.12088 Alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked
(generic).
721.12089 Alkenoic acid, alkyl-substituted alkyl ester, polymer with
(polyalkylamino)alkyl alkylalkenoate, alkyl-substituted
alkylalkenoate, .alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-
1,2-ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-
initiated, compds. with polyethylene glycol phosphoric acid-based
alkyl ether (generic).
721.12090 Maltodextrin, octanoate.
721.12091 Maltodextrin, hexadecanoate.
721.12092 Maltodextrin, decanoate.
721.12093 Maltodextrin, octadecanoate.
721.12094 Maltodextrin, dodecanoate.
721.12095 Maltodextrin, tetradecanoate.
721.12096 Dialkylhydroxylamine (generic).
721.12097 2-Tridecenoic acid, 2-acetyl-4-methyl-, ethyl ester.
721.12098 2-Alkyl-1,2-heteropolycycle-3-one (generic).
721.12099 1,2-Ethanediamine, N1, N2-dimethyl-N1-(1-methylethyl)-N2-
[2-[methyl(1-methylethyl)amino]ethyl]-.
721.12100 1,2-Cycloalkanedicarboxylic acid, 1,2-bis(2-oxiranylalkyl)
ester, reaction products with unsaturated carboxylic acid (generic).
721.12101 Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-
substituted polycarbocyclicalkanesulfonate (1:1) (generic).
721.12102 Formaldehyde, polymer with phenol, carboxyalkyl ethers,
alkali salts, compds. with (dialkylamino)alkanol (generic).
721.12103 Oxirane, alkyl-, polymer with oxirane, monoethers with
polyethylene glycol alkenyl ether (generic).
721.12104 Oxirane, alkyl-, polymer with oxirane, sulfate, ethers
with polyethylene glycol alkenyl ether, salt (generic).
721.12105 Alkanoic acid, substituted, polymer with substituted
Alkanoic acid, from fermentation of fermentable sugars (generic).
721.12106 2-Propenoic acid, 2-methyl-, C13-15-branched and linear
alkyl esters.
721.12107 Alken-1-ol (generic).
721.12108 Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-,
salt with dihalo-sulfoalkyl trisubstituted benzoate (generic).
721.12109 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt
with substituted-dihalobenzoate (generic).
721.12110 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt
with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle)
carbopolycycle (generic).
721.12111 Sulfonium, tris(4-fluorophenyl)-,
(substitutedphenoxy)alkyl substitutedbenzoate (1:1) (generic).
* * * * *
Sec. 721.12077 Oxirane, 2-methyl-, polymer with 2,4-diisocyanato-1-
methylbenzene, 2-methyloxirane polymer with oxirane ether with 1,2,3-
propanetriol (3:1), and oxirane, cashew nutshell liq.- and Pr alc. -
blocked.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with 2,4-diisocyanato-1-methylbenzene, 2-methyloxirane polymer
with oxirane ether with 1,2,3-propanetriol (3:1), and oxirane, cashew
nutshell liq.- and Pr alc. -blocked (PMN P-18-360; CASRN 1227870-90-7)
is subject to reporting under this section for the significant
[[Page 49223]]
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 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance other than as a two-component adhesive and protective coating
for marine and infrastructure applications.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12078 Alcohols, C8-10-iso-, C9-rich, ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alcohols, C8-10-
iso-, C9-rich, ethoxylated (PMN P-20-87; CASRN 2368929-19-3) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (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, serious eye damage, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance to a concentration of 3%
or greater in formulation for use in a consumer product. It is a
significant new use to use the substance other than as a surfactant in
hard surface cleaners and laundry detergents.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=142.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12079 Reaction product of polyester with .alpha.-
hydro-.omega.-hydroxypoly (oxy-1,4- butanediyl) and 1,1'-
methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of polyester with .alpha.-hydro-.omega.-hydroxypoly
(oxy-1,4- butanediyl) and 1,1'-methylenebis[isocyanatobenzene] (PMN P-
21-198; Accession No. 302217) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, respiratory sensitization, skin
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12080 Benzene, [2-[(2-methyl-1-undecen-1-yl) oxy]ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, [2-[(2-
methyl-1-undecen-1-yl) oxy]ethyl]- (PMN P-21-205; CASRN 2489743-82-8)
is subject to reporting under this section for the significant
[[Page 49224]]
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization, specific
target organ toxicity, and reproductive toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance for use in consumer
products where the concentration of the substance exceeds 1% by weight.
It is a significant new use to use the substance in consumer products
where the concentration of the substance exceeds 1% by weight.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12081 Siloxanes and Silicones, alkyl methyl, dimethyl
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, alkyl methyl, dimethyl (PMN P-21-213) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12082 Protein sodium complexes, polymers with aromatic acid
chloride, ethylene diamine and amino acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as protein
sodium complexes, polymers with aromatic acid chloride, ethylene
diamine and amino acid (PMN P-22-19; Accession No. 302206) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure to workers. It is a
significant new use to process the substance for use in consumer
products where the concentration of the confidential component of the
substance listed in the Order in the consumer product exceeds 0.1%. It
is a significant new use to use the substance in consumer products
where the concentration of the confidential component listed in the
Order exceeds 0.1%.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12083 Aryl-substituted-heterocyclic-polyamine, reaction
products with polyethylene glycol alkyl-ether, and nitrogen and alkyl-
substituted benzene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as aryl-
substituted-heterocyclic-polyamine, reaction products with polyethylene
glycol alkyl-ether, and nitrogen and alkyl-substituted benzene (PMN P-
22-22; Accession No. 302046) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been entrained in completely reacted or
cured ink.
(2) The significant new uses are:
[[Page 49225]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12084 Thermomycolin, Malbranchea cinnamomea origin,
expressed in genetically modified Trichoderma reesei.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as thermomycolin,
Malbranchea cinnamomea origin, expressed in genetically modified
Trichoderma reesei (PMN P-22-59) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance when in a formulation at a concentration of
0.1% or less.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, respiratory sensitization, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance other than by import
into the United States (i.e., no domestic manufacture) in a liquid
formulation. It is a significant new use to process for use or use the
substance in consumer products unless the concentration of the
substance in the consumer products is less than 0.1% by weight.
(iv) Release to water. It is a significant new use to release the
substance, or any waste stream containing the substance, into water
during processing unless the substance is deactivated before releasing
to water. To deactivate the New Chemical Substance, adjust the pH to 2
or below and incubate for 30 minutes.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12085 Oils, sandalwood, santalene synthase-modified
Rhodobacter sphaeroides-fermented, from D-Glucose, oxidized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, sandalwood,
santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-
Glucose, oxidized (PMN P-22-83; CASRN 2576531-09-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process for use or use the substance in consumer
products where the concentration of the substance exceeds 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1. For purposes of Sec.
721.91(a)(7), the control technology is primary and secondary
wastewater treatment as defined in 40 CFR part 133 and the percentage
removal of the substance resulting from use of the specified control
technology is 90%.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12086 Carboxylic acid substituted carbomonocycles, polymer
with dialkyl-alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl)
oxy]alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carboxylic acid substituted carbomonocycles, polymer
[[Page 49226]]
with dialkyl-alkanediol and alkanediol, hydroxy-alkyl-oxo-alkenyl)
oxy]alkyl ester (PMN P-22-89) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12087 4,8,11-Dodecatrienal.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4,8,11-
dodecatrienal (PMN P-22-90; CASRN 1000399-21-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to process
the substance for use in a consumer product unless the concentration of
the substance is less than 1% concentration by weight. It is a
significant new use to use the substance unless the concentration of
the substance in the product is less than 1% concentration by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=13.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12088 Alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanol, polymer with isocyanato-(isocyanatoalkyl)-
trialkylcarbomonocycle, alkylene glycol monoacrylate-blocked (PMN P-22-
91) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12089 Alkenoic acid, alkyl-substituted alkyl ester, polymer
with (polyalkylamino)alkyl alkylalkenoate, alkyl-substituted
alkylalkenoate, .alpha.-(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-1,2-
ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-initiated,
compds. with polyethylene glycol phosphoric acid-based alkyl ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkyl-substituted alkyl ester, polymer with
(polyalkylamino)alkyl alkylalkenoate, alkyl-substituted alkylalkenoate,
.alpha.-
[[Page 49227]]
(alkyl-oxo-alkenyl)-.omega.-alkoxypoly(oxy-1,2-ethanediyl), [(alkoxy-
alkyl-alkenyl)oxy]polyalkylsilane-initiated, compds. with polyethylene
glycol phosphoric acid-based alkyl ether (PMN P-22-93; Accession No.
302499) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (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: eye irritation and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=18.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12090 Maltodextrin, octanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
octanoate (PMN P-22-130; CASRN 2736503-99-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12091 Maltodextrin, hexadecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
hexadecanoate (PMN P-22-131; CASRN 1516876-50-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 49228]]
Sec. 721.12092 Maltodextrin, decanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
decanoate (PMN P-22-132; CASRN 1516876-47-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12093 Maltodextrin, octadecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
octadecanoate (PMN P-22-133; CASRN 1159570-68-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12094 Maltodextrin, dodecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
dodecanoate (PMN P-22-134; CASRN 512180-33-5) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to
[[Page 49229]]
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12095 Maltodextrin, tetradecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
tetradecanoate (PMN P-22-135; CASRN 2736504-00-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 1000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: serious eye damage and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
unless in aqueous dispersions. It is a significant new use to process
for use or use the substance in consumer products that are spray
applied. It is a significant new use to process for use or use the
substance in consumer products if the concentration of the substance is
equal to or exceeds 3% by weight. It is a significant new use to use
the substance as an agricultural wetting agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12096 Dialkylhydroxylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
Dialkylhydroxylamine (PMN P-22-139; Accession No. 302353) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been entrained
in an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance without using local
exhaust ventilation (LEV) and particulate filters with at least 90%
efficiency to control dust released to air. It is a significant new use
to conduct the form giving process on the substance without using LEV
and HEPA dust filters with at least 99% efficiency to control dust
released to air during transfer. It is a significant new use to conduct
the form giving process on the substance without using an enclosed
system with HEPA dust filters with at least 99% efficiency to control
dust released to air during all processing steps other than transfer.
It is a significant new use to use the substance other than as an
antioxidant process stabilizer.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12097 2-Tridecenoic acid, 2-acetyl-4-methyl-, ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-tridecenoic acid,
2-acetyl-4-methyl-, ethyl ester (PMN P-22-154; CASRN 960253-23-0) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) 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 sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that results in inhalation exposure. It is a significant new use
to process for use or use the substance in consumer products where the
concentration of the substance exceeds 1%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 49230]]
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12098 2-Alkyl-1,2-heteropolycycle-3-one (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
alkyl-1,2-heteropolycycle-3-one (PMN P-22-155; Accession No. 302717) 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), 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 corrosion, serious eye damage, 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), (o), (v)(1), (2), and (4), (w)(1),
(2), and (4), and (x)(1), (2), and (4).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12099 1,2-Ethanediamine, N1, N2-dimethyl-N1-(1-methylethyl)-
N2-[2-[methyl(1-methylethyl)amino]ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediamine,
N1, N2-dimethyl-N1-(1-methylethyl)-N2-[2-[methyl(1-
methylethyl)amino]ethyl]- (PMN P-22-157; CASRN 1042950-30-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000 during manufacturing
and processing (a respirator with an APF of at least 50 may be used if
a minimum ventilation airflow of 3,500 standard cubic feet per minute
is maintained in the work area), and a respirator with an APF of at
least 50 during use.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (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, reproductive toxicity,
specific target organ toxicity, 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. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance other than as a polyurethane catalyst. It is a significant
new use to process for use or use the substance at a concentration >3%
by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=650.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12100 1,2-Cycloalkanedicarboxylic acid, 1,2-bis(2-
oxiranylalkyl) ester, reaction products with unsaturated carboxylic
acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,2-
cycloalkanedicarboxylic acid, 1,2-bis(2-oxiranylalkyl) ester, reaction
products with unsaturated carboxylic acid (PMN P-22-167) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation, eye irritation, respiratory sensitization, skin
sensitization, and specific target organ toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
[[Page 49231]]
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=460.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12101 Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-
substituted polycarbocyclicalkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, polyfluoro-heteroatom-substituted
polycarbocyclicalkanesulfonate (1:1) (PMN P-22-192; Accession No.
302579) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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
process the substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12102 Formaldehyde, polymer with phenol, carboxyalkyl
ethers, alkali salts, compds. with (dialkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with phenol, carboxyalkyl ethers, alkali salts,
compds. with (dialkylamino)alkanol (PMN P-23-38) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace 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, skin sensitization,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a), (m), and (o). It is a significant new
use to manufacture or process the substance in any manner that results
in the generation of a vapor, mist, dust, or aerosol. It is a
significant new use to manufacture, process, or use the substance for
commercial use. It is a significant new use to process the substance
for use by a consumer as a consumer product.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=120.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12103 Oxirane, alkyl-, polymer with oxirane, monoethers with
polyethylene glycol alkenyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, alkyl-, polymer with oxirane, monoethers with polyethylene
glycol alkenyl ether (PMN P-23-42) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (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
[[Page 49232]]
substance may cause: skin corrosion, reproductive toxicity, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance. It is a significant new use to
use the substance other than as an intermediate for use in producing
polymers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12104 Oxirane, alkyl-, polymer with oxirane, sulfate, ethers
with polyethylene glycol alkenyl ether, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, alkyl-, polymer with oxirane, sulfate, ethers with
polyethylene glycol alkenyl ether, salt (PMN P-23-43) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (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. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance. It is a significant new use to
use the substance other than as an intermediate for use in producing
polymers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12105 Alkanoic acid, substituted, polymer with substituted
Alkanoic acid, from fermentation of fermentable sugars (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, substituted, polymer with substituted Alkanoic acid,
from fermentation of fermentable sugars (PMN P-23-61; Accession No.
302397) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted or cured or when incorporated
into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, skin
sensitization, and eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12106 2-Propenoic acid, 2-methyl-, C13-15-branched and
linear alkyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, C13-15-branched and linear alkyl esters (PMN P-23-74; CASRN
90552-04-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted such that less than 1 percent of
the substance remains.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(iii), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12107 Alken-1-ol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified
[[Page 49233]]
generically as alken-1-ol (PMN P-23-126; Accession No. 302580) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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: skin corrosion, skin
irritation, serious eye damage, eye irritation, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12108 Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-
, salt with dihalo-sulfoalkyl trisubstituted benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis (dihalo carbomonocycle) carbomonocycle-, salt with
dihalo-sulfoalkyl trisubstituted benzoate (PMN P-23-176; Accession No.
302386) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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
process the substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12109 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-,
salt with substituted-dihalobenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt with
substituted-dihalobenzoate (PMN P-23-179) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
adhered (during photolithographic processes) onto a semiconductor wafer
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 49234]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12110 Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-,
salt with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle)
carbopolycycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt with (dihalo-
sulfoalkyl) (halo-substituted carbomonocycle) carbopolycycle (PMN P-24-
42) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or adhered (during photolithographic
processes) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, 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(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12111 Sulfonium, tris(4-fluorophenyl)-,
(substitutedphenoxy)alkyl substitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tris(4-fluorophenyl)-, (substitutedphenoxy)alkyl
substitutedbenzoate (1:1) (PMN P-24-97) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
adhered (during photolithographic processes) onto a semiconductor wafer
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2025-19773 Filed 11-3-25; 8:45 am]
BILLING CODE 6560-50-P