[Federal Register Volume 90, Number 118 (Monday, June 23, 2025)]
[Rules and Regulations]
[Pages 26437-26453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11489]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2024-0077; FRL-12348-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
2.5e)
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 August 22, 2025. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on July
7, 2025.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2024-0077, 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: Punam Tyagi, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1176; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information on TSCA: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is 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 December 2, 2024 (89 FR 95688 (FRL-12348-01-
OCSPP)). The docket includes information considered by the Agency in
developing the proposed and these final rules, including public
comments and EPA's responses to the comments received as discussed in
Unit II.D.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in this document. The following list of
North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40
CFR part 707, subpart B. Importers of chemical substances in bulk form,
as part of a mixture, or as part of an article (if required by rule)
must certify that the shipment of the chemical substance complies with
all applicable rules and orders under TSCA, including regulations
issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance identified in this document are subject to
the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers and processors of
the chemical substances identified in this
[[Page 26438]]
document. This analysis, which is available in the docket, is briefly
summarized here.
1. Estimated Costs for SNUN Submissions
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN. If a
SNUN is submitted, costs are an estimated $45,000 per SNUN submission
for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)). These estimates reflect the costs and fees
as they are known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the pre-
existing export notification requirements under TSCA section 12(b) and
the implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
II. Background
A. General Information about SNURs
Unit II. of the proposed rule provides general information about
SNURs, and additional information about EPA's new chemical program is
available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
B. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA
concluded that the proposed significant new uses were not ongoing. If
EPA subsequently determines that such a use was ongoing as of the date
of publication of the proposed rule and did not cease prior to issuance
of the final rule, EPA will not designate that use as a significant new
use in the final rule. EPA has no information to suggest that any of
the significant new uses identified in this rule meet this criterion.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B)
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. The objective of EPA's approach is to
ensure that a person cannot impede finalization of a SNUR by initiating
a significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
In the unlikely event that before a final rule becomes effective a
person begins commercial manufacturing (including importing) or
processing of the chemical substances for a use that is designated as a
significant new use in that final rule, such a person would have to
cease any such activity upon the effective date of the final rule. To
resume their activities, these persons would have to first comply with
all applicable SNUR notification requirements and wait until all TSCA
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
[[Page 26439]]
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:
For PMN P-21-194 (40 CFR 721.11968), EPA has included the
90% primary and secondary wastewater treatment allowance as required in
the release to water section of the Order.
For PMNs P-23-49 (40 CFR 721.11988); P-23-124 (40 CFR
721.11989); P-23-50 (40 CFR 721.11990); P-23-83 (40 CFR 721.11991); P-
23-125 (40 CFR 721.11992); P-23-147 (40 CFR 721.11993); and P-23-104
(40 CFR 721.11994), EPA corrected the significant new use regarding the
manner in which the substance is imported. The significant new use now
reads ``It is a significant new use to import the substance other than
in solution, unless in sealed containers weighing 5 kilograms or
less.''
For PMNs P-21-202 (721.11969); P-23-49 (40 CFR 721.11988);
P-23-124 (40 CFR 721.11989); P-23-50 (40 CFR 721.11990); P-23-83 (40
CFR 721.11991); P-23-125 (40 CFR 721.11992); P-23-147 (40 CFR
721.11993); and P-23-104 (40 CFR 721.11994), EPA modified the hazard
communication requirements by adding a reference to 40 CFR 721.72(e)
and setting the associated de minimis concentration at 1.0%.
For PMNs P-23-83 (40 CFR 721.11991); P-23-125 (40 CFR
721.11992); and P-23-147 (40 CFR 721.11993), EPA corrected the
timeframe for manufacture to 9 months rather than 18 months.
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing, i.e.,
December 2, 2024 (89 FR 95688 (FRL-12348-01-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 are exempted 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.
The listing of the OMB control numbers of the collection
instruments and their subsequent codification in the table in 40 CFR
9.1 satisfies the display requirements of the PRA and OMB's
implementing regulations at 5 CFR part 1320. Since this ICR was
previously subject to public notice and comment prior to OMB approval,
and given the technical nature of the table in 40 CFR part 9, EPA finds
that further notice and comment to amend it is unnecessary. As a
result, EPA finds that there is ``good cause'' under section
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice
and comment.
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.).
[[Page 26440]]
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 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
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 17, 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 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, amend the table by adding entries for Sec. Sec.
721.11960 through 721.11994 in numerical order under the undesignated
center heading ``Significant New Uses of Chemical Substances'' to read
as follows:
[[Page 26441]]
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.11960........................................... 2070-0038
721.11961........................................... 2070-0038
721.11962........................................... 2070-0038
721.11963........................................... 2070-0038
721.11964........................................... 2070-0038
721.11965........................................... 2070-0038
721.11966........................................... 2070-0038
721.11967........................................... 2070-0038
721.11968........................................... 2070-0038
721.11969........................................... 2070-0038
721.11970........................................... 2070-0038
721.11971........................................... 2070-0038
721.11972........................................... 2070-0038
721.11973........................................... 2070-0038
721.11974........................................... 2070-0038
721.11975........................................... 2070-0038
721.11976........................................... 2070-0038
721.11977........................................... 2070-0038
721.11978........................................... 2070-0038
721.11979........................................... 2070-0038
721.11980........................................... 2070-0038
721.11981........................................... 2070-0038
721.11982........................................... 2070-0038
721.11983........................................... 2070-0038
721.11984........................................... 2070-0038
721.11985........................................... 2070-0038
721.11986........................................... 2070-0038
721.11987........................................... 2070-0038
721.11988........................................... 2070-0038
721.11989........................................... 2070-0038
721.11990........................................... 2070-0038
721.11991........................................... 2070-0038
721.11992........................................... 2070-0038
721.11993........................................... 2070-0038
721.11994........................................... 2070-0038
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. Sec. 721.11960 through 721.11994 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11960 Polyester polyol (generic).
721.11961 Polyester polyol (generic).
721.11962 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-
bis-[2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
721.11963 1-Propanamine, 3-methoxy-N,N-dimethyl-.
721.11964 Soybean oil, mixed esters with diethylene glycol, phthalic
acid and terephthalic acid.
721.11965 Soybean oil, epoxidized, polymer with bisphenol A, alkyl
glycidyl ether, epichlorohydrin, polyethylene glycol and
trihydroxyalkane (generic).
721.11966 Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl] alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium
sodium salts (generic).
721.11967 Siloxanes and silicones polyether, polymer with aliphatic
isocyanate, 2-dimethylaminoethanol and polyglycol ether (generic).
721.11968 Siloxanes and Silicones, di-Me,
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
721.11969 Sulfonium, carbomonocycle
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester
(generic).
721.11970 Aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
721.11971 Aromatic diacid, polymer with alkyldiacid, alkyldiols,
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11972 Aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, polypropylene, alkylhydroxyacid glycolester,
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (generic).
721.11973 Diketone compound metal complex (generic).
721.11974 Poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).
721.11975 Substituted polyalkylenepoly, reaction products with
substituted heteromonocycle substituted heteromonocycle polyalkylene
derivs (generic).
721.11976 Alkylphosphonic acid, calcium salt (generic).
721.11977 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (generic).
721.11978 Alkylamine, alkoxysilyl-, hydrolyzed (generic).
721.11979 Alkylphosphonic acid, disodium salt (generic).
721.11980 Alkenoic acid, alkanediyl ester, polymer with
bis(substituted alkyl)-alkanediol polymer with alkylene oxides
alkenoate, and alkanamine (generic).
721.11981 Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and
[(polyalkylsilyl)substituted]-terminated (generic).
721.11982 Cadmium tin oxide (Cd2Sn04).
721.11983 Polyhydroxyalkanoate (generic).
721.11984 Polyhydroxyalkanoate (generic).
721.11985 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
721.11986 Aromatic diacid, polymer with alkyldiols, hexanedioic
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene]
(generic).
721.11987 Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
721.11988 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate,
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
721.11989 Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).
721.11990 Substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate
(1:1), polymer with 3-ethenylphenol and
heterosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-
(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (generic).
721.11991 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate,
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
721.11992 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom
substituted carbomonocyclic-2-heteroatom substituted carbomonocyclic
heteropolycycle-5-alkanesulfonate (1:1) (generic).
721.11993 Sulfonium, tris(heteroatom-substituted carbomonocyclic),
salt with polyhydro-polyfluoro-heteroatom-substituted alkyl
heteropolycyclic-heteroatom-substituted aryl heteroatom-substituted
benzoate (1:1) (generic).
721.11994 Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic
ester (generic).
* * * * *
Sec. 721.11960 Polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polyol (PMN P-16-377) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For
[[Page 26442]]
purposes of Sec. 721.72(g)(1), this substance may cause: specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that would result in respirable particle sizes below 10
microns.
(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) and (f) 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. 721.11961 Polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polyol (PMN P-16-378) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) 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: 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.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that would result in respirable particle sizes below 10
microns.
(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) and (f) 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. 721.11962 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,
3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,4,8,10-tetraoxa-
3,9-diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1-methyl-1- phenylethyl)-
4-(1,1,3,3-tetramethylbutyl)phenoxy]- (PMN P-18-346; CASRN 1507339-21-
0) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (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: skin
sensitization, eye irritation, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) 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 (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. 721.11963 1-Propanamine, 3-methoxy-N,N-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanamine, 3-
methoxy-N,N-dimethyl- (PMN P-20-44; CASRN 20650-07-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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%.
(A) As an alternative to the respirator requirements in this
paragraph (a)(2)(i), a manufacturer or processor may choose to follow
the new chemical exposure limit (NCEL) provision listed in the TSCA
section 5(e) Order for this substance. The NCEL is 1.1388mg/m3 as an 8-
hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons who Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(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, 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. 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=1000.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 26443]]
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. 721.11964 Soybean oil, mixed esters with diethylene glycol,
phthalic acid and terephthalic acid.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean oil, mixed
esters with diethylene glycol, phthalic acid and terephthalic acid (PMN
P-21-21) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (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, 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3000.
(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. 721.11965 Soybean oil, epoxidized, polymer with bisphenol A,
alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and
trihydroxyalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as soybean
oil, epoxidized, polymer with bisphenol A, alkyl glycidyl ether,
epichlorohydrin, polyethylene glycol and trihydroxyalkane (PMN P-21-
151) 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
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (2), (g)(3)(iii), and (g)(5).
For purposes of Sec. 721.72(g)(1), this substance may cause:
respiratory sensitization, skin sensitization, and specific target
organ toxicity. For purposes of Sec. 721.72(g)(2), do not spray apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
or use the substance in a spray application.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=140.
(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. 721.11966 Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium
salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal,
[heteropoly cyclic]-, [[[(hydroxyalkyl)amino] sulfonyl)
alkyl]sulfonyl(sulfoalkyl) sulfonyl derivs., ammonium sodium salts (PMN
P-21-168) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(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)(4), (b)(4), and (c)(4), where N=178.
(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. 721.11967 Siloxanes and silicones polyether, polymer with
aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones polyether, polymer with aliphatic isocyanate,
2-dimethylaminoethanol
[[Page 26444]]
and polyglycol ether (PMN P-21-173) 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 embedded into a
textile fiber matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=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. 721.11968 Siloxanes and Silicones, di-Me, [gluconoylamino)alkyl]
dialkylammonio]- hydroxyalkoxy]alkyl group-terminated, (salts)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, (gluconoylamino)alkyl] dialkylammonio]-
hydroxyalkoxy]alkyl group-terminated, (salts) (PMN P-21-194) 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 incorporated into a
textile.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in the generation of a vapor, mist, dust, or aerosol.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=210. 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. 721.11969 Sulfonium, carbomonocycle
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, carbomonocycle bis((trihaloalkyl)carbomonocycle),
substituted carbomonocyclic ester (PMN P-21-202) 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), and (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 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).
[[Page 26445]]
(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. 721.11970 Aromatic diacids, polymer with alkyldiacids,
alkyldiols, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-208) 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, serious eye damage, eye irritation, respiratory
sensitization, skin sensitization, genetic toxicity, carcinogenicity,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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. 721.11971 Aromatic diacid, polymer with alkyldiacid, alkyldiols,
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene
glycol, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-209) 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, serious eye damage, eye irritation, respiratory
sensitization, skin sensitization, genetic toxicity, carcinogenicity,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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. 721.11972 Aromatic diacids, polymer with alkyldiacids,
alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid
glycolester, caprolactone and 1,1'-methylenebis[4- isocyanatobenzene]
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacids, polymer with alkyldiacids, alkyldiols,
benzofurandione, polypropylene, alkylhydroxyacid glycolester,
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (PMN P-21-210)
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, serious eye damage, eye irritation, respiratory
sensitization, skin sensitization, genetic toxicity, carcinogenicity,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as
[[Page 26446]]
specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(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. 721.11973 Diketone compound metal complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
diketone compound metal complex (PMN P-21-212) 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 completely entrained in dried/cured
ink.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin corrosion, serious eye damage, skin irritation, eye
irritation, 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(o) and (t). It is a significant new use to
manufacture the substance in excess of an annual volume of 1,000 kg/yr.
(iv) Disposal. It is a significant new use to dispose of the
substance or waste streams containing the substance other than by
hazardous waste incineration.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(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 (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. 721.11974 Poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (PMN P-21-214) 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 embedded into a textile fiber matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=4.
(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. 721.11975 Substituted polyalkylenepoly, reaction products with
substituted heteromonocycle substituted heteromonocycle polyalkylene
derivs (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyalkylenepoly, reaction products with substituted
heteromonocycle substituted heteromonocycle polyalkylene derivs. (PMN
P-22-18) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation and
[[Page 26447]]
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
for use or use the substance in consumer products at a concentration
greater than 3%. It is a significant new use to manufacture, process,
or use the substance in any manner that results in a dust, mist, or
aerosol.
(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. 721.11976 Alkylphosphonic acid, calcium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphosphonic acid, calcium salt (PMN P-22-21) 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 fully
reacted, cured, destroyed, or entrained in a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) 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: 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 use the substance in consumer products other
than in plastic articles and other plastic parts.
(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. 721.11977 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (PMN P-22-32) 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 (residual), skin
irritation (residual), eye irritation (residual), skin sensitization,
respiratory sensitization, genetic toxicity (residual), carcinogenicity
(residual), reproductive toxicity (residual), 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 a vapor, mist, aerosol, or dust.
(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. 721.11978 Alkylamine, alkoxysilyl-, hydrolyzed (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylamine, alkoxysilyl-, hydrolyzed (PMN P-22-33) 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)
[[Page 26448]]
through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, 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. 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 a vapor, mist, aerosol, or dust.
(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. 721.11979 Alkylphosphonic acid, disodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphosphonic acid, disodium salt (PMN P-22-34) 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 fully
reacted, cured, destroyed, or entrained in a polymer matrix.
(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: 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. 721.11980 Alkenoic acid, alkanediyl ester, polymer with
bis(substituted alkyl)-alkanediol polymer with alkylene oxides
alkenoate, and alkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkanediyl ester, polymer with bis(substituted alkyl)-
alkanediol polymer with alkylene oxides alkenoate, and alkanamine (PMN
P-22-35) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (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 1000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity, skin irritation, eye irritation, skin corrosion, serious eye
damage, respiratory sensitization, skin sensitization, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=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. 721.11981 Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and
[(polyalkylsilyl)substituted]-terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, mixed (polyhydro-substituted
heterocyclic) alkyl group and [(polyalkylsilyl)substituted]-terminated
(PMN P-22-38) 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), (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)
[[Page 26449]]
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: 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.
(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. 721.11982 Cadmium tin oxide (Cd2Sn04).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cadmium tin oxide
(Cd2Sn04) (PMN P-22-94; CASRN 12185-56-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 0.1%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, genetic toxicity, specific target organ toxicity, acute
toxicity, reproductive toxicity, and carcinogenicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11983 Polyhydroxyalkanoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyhydroxyalkanoate (PMN P-22-119) 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 plastic
or when completely 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), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) 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.
(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 (h) 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. 721.11984 Polyhydroxyalkanoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyhydroxyalkanoate (PMN P-22-120) 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 plastic
or when completely 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), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), 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
[[Page 26450]]
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.
(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 (h) 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. 721.11985 Glycolipids, sophorose-contg., yeast-fermented, from
glycerides and carbohydrates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycolipids, sophorose-contg., yeast-fermented, from glycerides and
carbohydrates (PMN P-22-151) 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.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=550.
(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. 721.11986 Aromatic diacid, polymer with alkyldiols, hexanedioic
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene]
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic diacid, polymer with alkyldiols, hexanedioic acid,
benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene] (PMN P-22-
178) 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, genetic toxicity, carcinogenicity, reproductive
toxicity, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure. It is a significant new use to manufacture,
process, or use the substance with residual MDI greater than 5% by
weight.
(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. 721.11987 Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, polymer
with 4,4'- bis(chloromethyl)-1,1'-biphenyl (PMN P-23-13; CASRN 208254-
04-0) 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) 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: 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.
(ii) 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) at
concentrations equal to or greater than the confidential concentration
percentage listed in the Order.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=260.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers,
[[Page 26451]]
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. 721.11988 Sulfonium, tricarbo-cyclic-, 2-aryl-
polyfluoropolyhydro-alkano-heteropolycycle-alkanesulfonate (1:1),
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo cyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-49) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or 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
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11989 Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic) (PMN P-23-124) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11990 Substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substitutedheterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (PMN P-23-50) 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
[[Page 26452]]
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
modify the processing or use the substance in any way that generates
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11991 Sulfonium, tricarbocyclic-, 2-aryl-
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1),
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo cyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-83) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the substance longer than 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. 721.11992 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-
heteroatom substituted carbomonocyclic-2-heteroatom substituted
carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbo cyclic-, polyfluoropolyhydro-heteroatom substituted
carbomonocyclic-2-heteroatom substituted carbomonocyclic
heteropolycycle-5-alkanesulfonate (1:1) (PMN P-23-125) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to
[[Page 26453]]
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. 721.11993 Sulfonium, tris(heteroatom-substituted
carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted
alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-
substituted benzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tris(heteroatom-substituted carbomonocyclic), salt with
polyhydro-polyfluoro-heteroatom-substituted alkyl heteropolycyclic-
heteroatom-substituted aryl heteroatom-substituted benzoate (1:1) (PMN
P-23-147) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye
damage, skin sensitization, genetic toxicity, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
modify the processing of the substance in any way that generates dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the substance longer than 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. 721.11994 Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle],
disubstituted carbomonocyclic ester (PMN P-23-104) 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. 2025-11489 Filed 6-20-25; 8:45 am]
BILLING CODE 6560-50-P