[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Rules and Regulations]
[Pages 35624-35639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14256]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721 and 725
[EPA-HQ-OPPT-2024-0074; FRL-11916-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
1.5e)
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 a Microbial
Commercial Activity Notice (MCAN) and are also subject to an Order
issued by EPA pursuant to TSCA. The SNURs require persons to notify EPA
at least 90 days before commencing the manufacture (defined by statute
to include import) or processing of any of these chemical substances
for an activity that is designated as a significant new use in the
SNUR. The required notification initiates EPA's evaluation of the
conditions of that use for that chemical substance. In addition, the
manufacture or processing for the significant new use may not commence
until EPA has conducted a review of the required notification; made an
appropriate determination regarding that notification; and taken such
actions as required by that determination.
DATES: This rule is effective on September 29, 2025. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
August 12, 2025.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2024-0074, 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: Geraldine Hilton, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-8986; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information on TSCA: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the factors in TSCA section 5(a)(2).
B. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical
substances identified in this document. These chemical substances were
the subject of PMNs and a Microbial Commercial Activity Notice (MCAN)
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 August 20, 2024 (89 FR 67368 (FRL-11916-01-OCSPP)).
The docket includes information considered by the Agency in developing
the proposed and final rules, including public comments and EPA's
responses to the comments received as discussed in Unit II.D.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in this document. The following list of
North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a
[[Page 35625]]
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 or 40 CFR 725.920 (for microorganisms),
any persons who export or intend to export a chemical substance
identified in this document are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers and processors of
the chemical substances identified in this document. This analysis,
which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN. If a
SNUN is submitted, costs are an estimated $45,000 per SNUN submission
for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)). These estimates reflect the costs and fees
as they are known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the pre-
existing export notification requirements under TSCA section 12(b) and
the implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
II. Background
A. General Information About SNURs
Unit II. of the proposed rule provides general information about
SNURs, and additional information about EPA's new chemical program is
available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
B. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA
concluded that the proposed significant new uses were not ongoing. If
EPA subsequently determines that such a use was ongoing as of the date
of publication of the proposed rule and did not cease prior to issuance
of the final rule, EPA will not designate that use as a significant new
use in the final rule. EPA has no information to suggest that any of
the significant new uses identified in this rule meet this criterion.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B)
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. The objective of EPA's approach is to
ensure that a person cannot impede finalization of a SNUR by initiating
a significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
In the unlikely event that before a final rule becomes effective a
person begins commercial manufacturing (including importing) or
processing of the chemical substances for a use that is designated as a
significant new use in that final rule, such a person would have to
cease any such activity upon the effective date of the final rule. To
resume their activities, these persons would have to first comply with
all applicable SNUR notification requirements and wait until all TSCA
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
[[Page 35626]]
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 or 40 CFR 725.160 [for microorganisms]).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing. To assist with EPA's analysis of the SNUN,
submitters are encouraged, but not required, to provide the potentially
useful information as identified for the chemical substance in Unit
III.C. of the proposed rule.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit III. of the
proposed rule may not be the only means of providing information to
evaluate the chemical substance associated with the significant new
uses. However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA sections 5(e) or 5(f).
EPA recommends that potential SNUN submitters contact EPA early enough
so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
D. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed SNURs and prepared a
Response to Comment document that provides the Agency responses. The
comments and the Response to Comment document are available in the
docket. As described in the Response to Comment document, EPA is
finalizing these SNURs with the following changes (listed by PMN Number
and proposed 40 CFR citation):
For P-20-175 (40 CFR 721.11897), P-20-176 (40 CFR
721.11898), and P-20-178 (40 CFR 721.11899), based upon review of
submitted data indicating the substances are expected to have low
environmental hazard, EPA removed the proposed release to water
requirements and also modified the proposed hazard communication
requirements by removing the proposed reference to 40 CFR 721.72(g)(3);
and,
For P-22-86 (40 CFR 721.11918), P-22-122 (40 CFR
721.11919), P-22-179 (40 CFR 721.11920), P-22-180 (40 CFR 721.11921),
and P-22-129 (40 CFR 721.11923), EPA incorporated the requirements of
40 CFR 721.72(e) to include a de minimis provision of 1.0% (for P-22-
86, P-22-122, and P-22-0129) or 0.1% (for P-22-179 and P-22-180) for
consistency with the underlying Orders for these substances. For P-22-
86, P-22-122, P-22-0179, and P-22-180, EPA also corrected the
significant new use regarding the manner in which the substance is
imported. The significant new use now reads ``It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less.''
In addition to the changes to respond to comments, EPA identified
the need to revise the following proposed SNURs (listed by PMN Number
and proposed 40 CFR citation):
For P-22-13 (40 CFR 721.11913) and P-22-15 (40 CFR
721.11914), EPA made minor edits to the significant new use regarding
the use of dust collection in the industrial, commercial, and consumer
activities paragraph to be consistent with the Order.
For P-18-356 (40 CFR 721.11894), P-18-357 (40 CFR
721.11895), P-19-188 (40 CFR 721.11896), P-21-32 (40 CFR 721.11901), P-
21-33 (40 CFR 721.11902), P-21-96 (40 CFR 721.11905), P-21-98 (40 CFR
721.11906), P-21-126 (40 CFR 721.11907), P-21-175 (40 CFR 721.11908),
P-22-10 (40 CFR 721.11912), P-22-13 (40 CFR 721.11913), P-22-15 (40 CFR
721.11914), P-22-37 (40 CFR 721.11914), P-22-54 (40 CFR 721.11917), and
P-22-162 (40 CFR 721.11924), EPA simplified the requirements in the
hazard communication paragraph by referencing 40 CFR 721.72(g)(3)(iii)
rather than referencing 721.72(g)(3) and writing out the required
environmental hazard statement.
For P-20-178 (40 CFR 721.11899), EPA updated the generic
name of the chemical substance. A provisional generic name was used in
the proposed rule.
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.,
August 20, 2024 (89 FR 67368 (FRL-11916-01-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
[[Page 35627]]
found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action establishes SNURs for new chemical substances that were
the subject of PMNs. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order 12866
(58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because a significant new use rule for a new chemical under TSCA
section 5 is exempt from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in
FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction
of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-
5597-1)), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive 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.
[[Page 35628]]
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 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
40 CFR Part 725
Environmental protection, Administrative practice and procedure,
Biologics, Chemicals, Hazardous substances, Imports, Labeling,
Occupational safety and health, Reporting and recordkeeping
requirements.
Dated: July 24, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, 40 CFR chapter I is amended
as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11894 through 721.11924 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.11894 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, sodium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated phenolic resin salt, polymer with acetone-phenol reaction
products, formaldehyde and phenol, sodium salt (PMN P-18-356) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii) and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion; serious
eye damage; reproductive toxicity; 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=6.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11895 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, potassium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated phenolic resin salt, polymer with acetone-phenol reaction
products, formaldehyde and phenol, potassium salt (PMN P-18-357) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii) and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion; serious
eye damage; reproductive toxicity; 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=6.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11896 Octadecanamide, N,N-dialkyl, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
octadecanamide, N,N-dialkyl, salts (PMN P-19-188) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
[[Page 35629]]
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (g)(3)(iii) and (g)(5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity; serious eye damage.
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=34.
(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. 721.11897 Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl,
methyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid N-
[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (PMN P-20-
175) 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: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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) 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. 721.11898 Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl
ester (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as acid N-
(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (PMN P-20-176) 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: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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) 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. 721.11899 Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(isocyanatophenyl) alkyl]carbocycle]amino]carbonyl]oxy]ethyl ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(isocyanatophenyl)
alkyl] carbocycle]amino]carbonyl]oxy]ethyl ester (PMN P-20-178) 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
[[Page 35630]]
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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) 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. 721.11900 Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines, C36-
alkylenedi-, polymers with 5,5'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis[2-aminophenol] (PMN P-21-15; CASRN
2419899-87-7) 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 (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 use the substance other than as a raw material
in a temporary bonding adhesive formulation. The adhesive is used to
bond completed semiconductor wafers to a backing substrate to
facilitate mechanical grinding of the wafer to reduce its thickness. It
is a significant new use to manufacture, process, or use the substance
in any manner that results in worker 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 (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. 721.11901 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)-
(PMN P-21-32; CASRN 2304726-48-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity; skin corrosion; serious eye damage; skin sensitization;
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
or use the substance in any manner in formulation containing the
substance at greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy- (PMN P-21-33; CASRN 2304726-50-7), N
should be calculated using the combined number of kilograms of both
substances released per site per day.
(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. 721.11902 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (PMN P-21-33;
CASRN 2304726-50-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (g)(3)(iii) and
[[Page 35631]]
(g)(5). For purposes of Sec. 721.72(g)(1), this substance may cause:
acute toxicity; skin corrosion; serious eye damage; skin sensitization;
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
or use the substance in any manner in formulation containing the
substance at greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-21-32; CASRN 2304726-48-
3), N should be calculated using the combined number of kilograms of
both substances released per site per day.
(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. 721.11903 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer
with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with
dialkyalkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-
[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl
carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with
dialkyalkanamine (PMN P-21-75) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50, or 1000 if spray
applied.
(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 corrosion;
skin irritation; serious eye damage; eye irritation; respiratory
sensitization; reproductive toxicity; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11904 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide,
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol
and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol
reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-
alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted
carbomonocycle, dialkylalkanediol and polyalkylene
glycol(hydroxyalkyl)alkyl alkyl ether (PMN P-21-80) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50, or 1000 if spray
applied.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11905 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)
bis[heteromonocycle], bis(2-methyl-2-propenoate) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with 2,2'-[(1-
methylethylidene)bis(4,1-
[[Page 35632]]
phenyleneoxymethylene)] bis[heteromonocycle], bis(2-methyl-2-
propenoate) (PMN P-21-96) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii) and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation; eye irritation; respiratory sensitization; skin
sensitization; reproductive toxicity; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11906 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or
3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.',
.alpha.''-ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted
benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.''-ether with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-21-98) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii) and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: skin
irritation; eye irritation; skin sensitization; specific target organ
toxicity; 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 or process the substance in any manner or method that
results in inhalation exposure. It is a significant new use to use the
substance in formulations at concentrations greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=12.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11907 Substituted heteromonocycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine,
(alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol],
reaction products with metal oxide and dialkanolamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted heteromonocycle, polymer with haloalkyl substituted
heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-
carbomonocycle] and oxybis[alkanol], reaction products with metal oxide
and dialkanolamine (PMN P-21-126) 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 destroyed.
(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=230.
(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. 721.11908 Carbonic acid, diphenyl ester, polymer with 1,4-
butanediol and 1,10-decanediol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol (PMN P-
21-175; CASRN 1615685-41-0) 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 destroyed.
(2) The significant new uses are:
[[Page 35633]]
(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=22.
(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), 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. 721.11909 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-
alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 3,5,8-
trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-
2,6-dialkyl-7-oxo-, alkyl ester (PMN P-22-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or 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: eye irritation; reproductive
toxicity; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process for use or use the substance other than
as a crosslinker in formulating general purpose sealants and adhesives.
It is a significant new use to process for use or use the substance in
consumer products other than in the form of a paste. It is a
significant new use to process for use or use the substance where the
concentration of the substance exceeds 6% by weight in consumer
products. 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. 721.11910 .beta.-N-Acetylhexosaminidase (expressed in
genetically modified Bacillus licheniformis strain ATJI0138).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as .beta.-N-
acetylhexosaminidase (expressed in genetically modified Bacillus
licheniformis strain ATJI0138) (PMN P-22-8; CASRN 9012-33-3) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure. It is a significant new
use to process the substance to greater than 1% in formulation for use
in a consumer product.
(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. 721.11911 Alkanes, C4-9-branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C4-9-
branched and linear (PMN P-22-9; CASRN 2577172-51-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
incorporated into a fuel or refined or blended into other chemical or
fuel formulations.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than as a fuel, a refinery feedstock, a chemical feedstock, or a fuel
blending additive or component.
[[Page 35634]]
(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 (f), and (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. 721.11912 Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-,
3-(trimethoxysilyl)propyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino
alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-
(trimethoxysilyl)propyl ester (PMN P-22-10) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii) and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; serious
eye damage; reproductive toxicity; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=80.
(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. 721.11913 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo,
aryl ester (PMN P-22-13) 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) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii) and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: eye
irritation; skin sensitization; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture, process, or use the substance in solid form without using
a dust collection system with a combined capture and control efficiency
of at least 32%.
(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. 721.11914 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo-
(PMN P-22-15) 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) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. 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; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture, process, or use the substance in solid form without using
a dust collection
[[Page 35635]]
system with a combined capture and control efficiency of at least 32%.
(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. 721.11915 Polyphosphoric acids, esters with heteromonocycle
homopolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyphosphoric acids, esters with heteromonocycle homopolymer (PMN P-
22-37) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii) and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion; skin
irritation; serious eye damage; eye irritation; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
the substance to greater than 1% in formulation. It is a significant
new use to use the substance in a formulation containing the substance
at a concentration greater than 1%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
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. 721.11916 Silica gel, reaction products with alkyl metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silica
gel, reaction products with alkyl metal salt (PMN P-22-44) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
completely destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. 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: eye irritation; skin
irritation; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c).
(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. 721.11917 Graphene nanoplatelets (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
graphene nanoplatelets (PMN P-22-54) 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:
(i) Completely reacted or cured; or
(ii) Embedded into a permanent solid polymer form that is not
intended to undergo further processing, except mechanical processing or
physical blending.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(iii) and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this
[[Page 35636]]
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(k), (v)(3), and (x)(3). It is a
significant new use to manufacture the substance other than by import
into the United States in the form of a solution (i.e., no domestic
manufacture). It is a significant new use to process the substance in
any manner that generates inhalation exposure. It is a significant new
use to use the substance in an application method where the
concentration of the substance in the formulation exceeds the
confidential concentration listed in the Order.
(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. 721.11918 Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-
carbopolycycle, hetero-acid)benzenesulfonate (1:1) (PMN P-22-86) 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; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, 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. 721.11919 Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-
trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1)
(PMN P-22-122) 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; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, 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. 721.11920 Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt
with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
[[Page 35637]]
trisubstitutedbenzoate (1:1) (PMN P-22-179) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or adhered (during photolithographic processes) onto a semiconductor
wafer surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e) the
concentration is set at 0.1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic toxicity; carcinogenicity; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, 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. 721.11921 Dibenzothiophenium, 5-phenyl-, 4-[1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl
trisubstitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-
triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1)
(PMN P-22-180) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic 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 0.1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic toxicity; carcinogenicity; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, 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. 721.11922 .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-
1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl
ethers, chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as .beta.-
cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-
benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers,
chlorides (PMN P-22-115; CASRN 2683011-63-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been incorporated into
an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), 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; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
particle size less than 20 microns. It is a significant new use to
process for use or use the
[[Page 35638]]
substance in consumer products except when incorporated into an
article.
(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. 721.11923 Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate,
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate
and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate,
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate
and 4-hydroxyphenyl 2-methyl-2-propenoate (PMN P-22-129) 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; 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 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. 721.11924 Haloalkylfurancarboxaldehyde (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
haloalkylfurancarboxaldehyde (PMN P-22-162) 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
(destroyed).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (g)(3)(iii) and (g)(5). For
purposes of Sec. 721.72(g)(1), this substance may cause: acute
toxicity; skin irritation; serious eye damage; skin sensitization;
genetic toxicity; reproductive toxicity; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c), and (o). It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
(iv) Disposal. It is a significant new use to dispose of the
substance, or any waste streams containing the substance, other than by
hazardous waste incineration achieving at least 99.99% destruction of
the substance.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=540.
(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.
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
3. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
4. Add Sec. Sec. 725.1082 to subpart M to read as follows:
Subpart M--Significant New Uses for Specific Microorganisms
Sec. 725.1082 Microorganism expressing enzymes (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically-modified microorganism identified generically as
microorganism expressing enzymes (MCAN J-23-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) It is a significant new use to manufacture, process, or use the
microorganism other than in a
[[Page 35639]]
fermentation system that meets all of the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate
to which the microorganism fermentation broth is added after the
standard industrial fermentation is completed is initiated only after
the inactivation of the microorganism as delineated in Sec.
725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and
processors of this microorganism.
(2) Modification or revocation of certain notification
requirements. The provisions of Sec. 725.984 apply to this section.
[FR Doc. 2025-14256 Filed 7-28-25; 8:45 am]
BILLING CODE 6560-50-P